As filed with the U.S. Securities and Exchange Commission on May 1, 2026.

Registration No.

UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549

FORM S-1
REGISTRATION STATEMENT
UNDER
THE SECURITIES ACT OF 1933

Lakewood-Amedex Biotherapeutics Inc.
(Exact Name of Registrant as Specified in its Charter)

Nevada		2834		20-5274304
(State or Other Jurisdiction of Incorporation or Organization)		(Primary Standard Industrial Classification Code Number)		(I.R.S. Employer Identification Number)

8031 Cooper Creek Blvd., Unit 103
University Park, Florida 34201
Telephone: (941) 225-2515
(Address, Including Zip Code, and Telephone Number, Including Area Code, of Registrant’s Principal Executive Offices)

Kelvin Cooper
8031 Cooper Creek Blvd., Unit 103
University Park, Florida 34201
Telephone: (941) 225-2515
(Name, Address, Including Zip Code, and Telephone Number, Including Area Code, of Agent for Service)

Copies to:

Joseph M. Lucosky, Esq.
Lucosky Brookman LLP
101 Wood Avenue South, 5^th Floor
Woodbridge, NJ 08830
Tel. No.: (732) 395-4400
Fax No.: (732) 395-4401

Approximate date of commencement of proposed sale to the public: As soon as practicable after this registration statement becomes effective.

If any of the securities being registered on this Form are to be offered on a delayed or continuous basis pursuant to Rule 415 under the Securities Act of 1933, check the following box. ☒

If this form is filed to register additional securities for an offering pursuant to Rule 462(b) under the Securities Act, check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering. ☐

If this form is a post-effective amendment filed pursuant to Rule 462(c) under the Securities Act, check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering. ☐

If this form is a post-effective amendment filed pursuant to Rule 462(d) under the Securities Act, check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering. ☐

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company” and “emerging growth company” in Rule 12b-2 of the Exchange Act.

Large accelerated filer	☐	Accelerated filer	☐
Non-accelerated filer	☒	Smaller reporting company	☒
		Emerging growth company	☒

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 7(a)(2)(B) of the Securities Act. ☐

The Registrant hereby amends this Registration Statement on such date or dates as may be necessary to delay its effective date until the Registrant shall file a further amendment which specifically states that this Registration Statement shall thereafter become effective in accordance with Section 8(a) of the Securities Act of 1933 or until this Registration Statement shall become effective on such date as the Securities and Exchange Commission, acting pursuant to said Section 8(a), may determine.

The information in this preliminary prospectus is not complete and may be changed. Neither we nor the Selling Stockholders may not sell these securities until the registration statement filed with the Securities and Exchange Commission is effective. This preliminary prospectus is not an offer to sell these securities and is not soliciting an offer to buy these securities in any jurisdiction where the offer or sale is not permitted.

SUBJECT TO COMPLETION, DATED May 1, 2026

PROSPECTUS

LAKEWOOD-AMEDEX BIOTHERAPEUTICS INC.

9,647,726 Shares of
Common Stock

This prospectus relates to the resale from time to time of up to (i) 9,375,000 shares of common stock, par value $0.0001 per share, of Lakewood-Amedex Biotherapeutics Inc., or Common Stock, by a certain selling stockholder with whom we have entered into a securities purchase agreement and registration rights agreement pursuant to a private placement in January 2026, including their pledgees, assignees, donees, transferees or their respective successors-in-interest, or the Investor Selling Stockholder, which is the maximum amount of shares of our Common Stock that may be issued upon conversion of our Series C Preferred Stock held by the Investor Selling Stockholder and (ii) 272,726 shares of our Common Stock held by RBW Capital Partners LLC, or RBW, which were issued to RBW by the company in April 2026 as partial consideration for RBW’s services pursuant to an advisory agreement between the company and RBW dated February 10, 2025, as amended, or the Advisory Agreement. The Investor Selling Stockholder and RBW are collectively referred to herein as the “Selling Stockholders”.

We will not receive any proceeds from the sale of the shares of the Common Stock covered by this prospectus.

Sales of the shares by the Selling Stockholders may occur at fixed prices, at market prices prevailing at the time of sale, at prices related to prevailing market prices or at negotiated prices. The Selling Stockholders may sell the shares to or through underwriters, broker-dealers or agents, who may receive compensation in the form of discounts, concessions or commissions from the Selling Stockholders, the purchasers of the shares, or both.

We are paying the cost of registering the shares as well as various related expenses. The Selling Stockholders are responsible for all selling commissions, transfer taxes and other costs related to the offer and sale of their shares. See “Plan of Distribution” for more information about how the Selling Stockholders may sell or dispose of their shares.

Our Common Stock is traded on The Nasdaq Capital Market under the symbol “LABT.” On 30, 2026, the last reported sale price of our Common Stock was $2.66 per share.

We are an “emerging growth company” as defined under U.S. federal securities laws and, as such, have elected to comply with reduced public company reporting requirements.

Investing in our common stock involves risks. See the “Risk Factors” section beginning on page 11 for risks you should consider before investing in our common stock.

Neither the Securities and Exchange Commission nor any state securities commission has approved or disapproved of these securities or determined if this prospectus is truthful or complete. Any representation to the contrary is a criminal offense.

The date of this prospectus is , 2026

TABLE OF CONTENTS

		Page
CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS		ii
About this Prospectus		iv
PROSPECTUS SUMMARY		1
IMPLICATIONS OF BEING AN EMERGING GROWTH COMPANY AND A SMALLER REPORTING COMPANY		7
SUMMARY OF RISK FACTORS		7
CORPORATE INFORMATION		9
SUMMARY HISTORICAL FINANCIAL AND OTHER DATA		10
RISK FACTORS		11
USE OF PROCEEDS		36
DIVIDEND POLICY		37
MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS		38
BUSINESS		50
MANAGEMENT		92
EXECUTIVE AND DIRECTOR COMPENSATION		98
CERTAIN RELATIONSHIPS AND RELATED PERSON TRANSACTIONS		104
PRINCIPAL STOCKHOLDERS		106
DESCRIPTION OF CAPITAL STOCK		107
SELLING STOCKHOLDERS		110
PLAN OF DISTRIBUTION		111
MATERIAL U.S. FEDERAL INCOME TAX CONSEQUENCES TO NON-U.S. HOLDERS		113
LEGAL MATTERS		119
EXPERTS		119
WHERE YOU CAN FIND MORE INFORMATION		119
INDEX TO FINANCIAL STATEMENTS		F-1

CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS

This prospectus includes statements that express our opinions, expectations, beliefs, plans, objectives, assumptions, or projections regarding future events or future results and therefore are, or may be deemed to be, “forward-looking statements.” All statements other than statements of historical facts contained in this prospectus may be forward-looking statements. These forward-looking statements can generally be identified by the use of forward-looking terminology, including the terms “believes,” “estimates,” “continues,” “anticipates,” “expects,” “seeks,” “projects,” “intends,” “plans,” “may,” “will,” “would” or “should” or, in each case, their negative or other variations or comparable terminology. They appear in a number of places throughout this prospectus, and include statements regarding our intentions, beliefs, or current expectations concerning, among other things, our results of operations, financial condition, liquidity, prospects, growth, strategies, future acquisitions, and the industry in which we operate. By their nature, forward-looking statements involve risks and uncertainties because they relate to events and depend on circumstances that may or may not occur in the future. We believe that these risks and uncertainties include, but are not limited to, those described in the “Risk Factors” section of this prospectus. These factors should not be construed as exhaustive and should be read with the other cautionary statements in this prospectus. Although we base these forward-looking statements on assumptions that we believe are reasonable when made, we caution you that forward-looking statements are not guarantees of future performance and that our actual results of operations, financial condition, and liquidity, and industry developments may differ materially from statements made in or suggested by the forward-looking statements contained in this prospectus. The matters summarized under “Prospectus Summary,” “Risk Factors,” “Management’s Discussion and Analysis of Financial Condition and Results of Operations,” “Business,” and elsewhere in this prospectus could cause our actual results to differ significantly from those contained in our forward-looking statements. In addition, even if our results of operations, financial condition, and liquidity, and industry developments are consistent with the forward-looking statements contained in this prospectus, those results or developments may not be indicative of results or developments in subsequent periods. In light of these risks and uncertainties, we caution you not to place undue reliance on these forward-looking statements. Any forward-looking statement that we make in this prospectus speaks only as of the date of such statement, and we undertake no obligation to update any forward-looking statement or to publicly announce the results of any revision to any of those statements to reflect future events or developments, except as required by applicable law. Comparisons of results for current and any prior periods are not intended to express any future trends or indications of future performance, unless specifically expressed as such, and should only be viewed as historical data.

You should not rely upon forward-looking statements as predictions of future events. We have based the forward-looking statements contained in this prospectus primarily on our current expectations and projections about future events and trends that we believe may affect our business, financial condition, results of operations, and prospects. The outcome of the events described in these forward-looking statements is subject to risks, uncertainties, and other factors described in “Risk Factors” and elsewhere in this prospectus. Moreover, we operate in a competitive and rapidly changing environment. New risks and uncertainties emerge from time to time, and it is not possible for us to predict all risks and uncertainties that could have an impact on the forward-looking statements contained in this prospectus. The results, events, and circumstances reflected in the forward-looking statements may not be achieved or occur, and actual results, events, or circumstances could differ materially from those described in the forward-looking statements.

The forward-looking statements made in this prospectus relate only to events as of the date on which the statements are made. We undertake no obligation to update any forward-looking statements made in this prospectus to reflect events or circumstances after the date of this prospectus or to reflect the latest information or the occurrence of unanticipated events, except as required by law. We may not actually achieve the plans, intentions, or expectations disclosed in our forward-looking statements, and you should not place undue reliance on our forward-looking statements. Our forward-looking statements do not reflect the potential impact of any future acquisitions, mergers, dispositions, joint ventures, or investments we may make.

In addition, statements that “we believe” and similar statements reflect our beliefs and opinions on the relevant subject. These statements are based upon information available to us as of the date of this prospectus, and while we believe such information forms a reasonable basis for such statements, such information may be limited or incomplete, and our statements should not be read to indicate that we have conducted an exhaustive inquiry into, or review of, all potentially available relevant information. These statements are inherently uncertain, and you are cautioned not to unduly rely upon these statements.

USE OF MARKET AND INDUSTRY DATA

This prospectus includes market and industry data that has been obtained from third-party sources, including industry publications, as well as industry data prepared by our management on the basis of its knowledge and experience in the industries in which we operate (including our management’s estimates and assumptions relating to those industries based on that knowledge). Furthermore, references in this prospectus to any publications, reports, surveys, or articles prepared by third parties should not be construed as depicting the complete findings of the entire publication, report, survey, or article, including those discussed under the section entitled “Risk Factors” and elsewhere in this prospectus. Some data are also based on our good-faith estimates. The information in any such publication, report, survey, or article is not incorporated by reference in this prospectus.

TRADEMARKS

We own or have rights to various trademarks, service marks, and trade names that we use in connection with the operation of our business. This prospectus may also contain trademarks, service marks, and trade names of third parties, which are the property of their respective owners. Our use or display of third parties’ trademarks, service marks, trade names, or products in this prospectus is not intended to, and does not imply a relationship with, or endorsement or sponsorship by us. Solely for convenience, the trademarks, service marks and trade names referred to in this prospectus may appear without the ^®, ^™ or ^℠ symbols, but the omission of such references is not intended to indicate, in any way, that we will not assert, to the fullest extent under applicable law, our rights or the right of the applicable owner of these trademarks, service marks and trade names.

iii

ABOUT THIS PROSPECTUS

This prospectus is part of a registration statement on Form S-1 that we filed with the Securities and Exchange Commission, or the SEC, using the “shelf” registration process. Under this shelf registration process, the Selling Stockholders may, from time to time, sell the shares offered by them described in this prospectus. Under this process, the Selling Stockholders may, from time to time, sell the Common Stock covered by this prospectus in the manner described in the section titled “Plan of Distribution.” Additionally, we may provide a prospectus supplement to add information to, or update or change information contained in, this prospectus, including the section titled “Plan of Distribution.” You may obtain this information without charge by following the instructions under the “Where You Can Find Additional Information” section appearing elsewhere in this prospectus. You should read this prospectus and any prospectus supplement before deciding to invest in our common stock.

PROSPECTUS SUMMARY

This summary highlights information contained in greater detail elsewhere in this prospectus and does not contain all of the information that you should consider before deciding to invest in our common stock. You should read the entire prospectus carefully, including the sections titled “Risk Factors,” “Management’s Discussion and Analysis of Financial Condition and Results of Operations,” and our financial statements and the related notes included in this prospectus, before making an investment decision. Some of the statements in this prospectus constitute forward-looking statements. See the “Cautionary Note Regarding Forward-Looking Statements.” Unless otherwise indicated in this prospectus, “Lakewood-Amedex”, “the Corporation”, “the Company”, “we”, “us”, and “our” refer to Lakewood-Amedex Biotherapeutics Inc. and, where appropriate, its subsidiaries.

Overview

We are a biotechnology company focused on leveraging unique, pioneering science to address unmet needs in the treatment of infectious diseases, improving patient outcomes, and significantly reducing the threat posed by antibiotic-resistant bacterial strains, including methicillin resistant Staphylococcus aureus (MRSA), vancomycin resistant Enterococci species (VRE), and others. Antimicrobial resistance (AMR) represents a growing global health crisis, being directly responsible for 1.27 million deaths annually and contributing to nearly 5 million deaths worldwide. The rapid rise of resistant pathogens has rendered many existing antibiotics ineffective against these pathogens, increasing the risk of severe infections, prolonged hospital stays, and substantial economic burdens. Despite this urgent need, the development of new antibiotics has slowed, with most advancements occurring within existing drug classes, leaving these new compounds vulnerable to resistance mechanisms.

Our product candidates consist of antimicrobials targeting acute and chronic infectious diseases, which are delivered locally to the site of infection. As of March 2026, we hold 68 issued and 36 pending patent applications for our products and technologies, with coverage in major pharmaceutical markets. We have successfully completed our first exploratory human clinical trials for our lead product, the broad-spectrum Bisphosphocin^® (anti-bacterial) Nu-3, which is being developed for the topical treatment of mildly infected diabetic foot ulcers (iDFU). We plan to conduct an initial Phase 2a safety and dose response study, followed by a placebo-controlled Phase 2b dose comparative study to identify the optimal dose for Phase 3 trials and eventual commercialization. This study will also determine the most appropriate administration regimen for Nu-3 gel formation in mildly infected diabetic foot ulcers. Additionally, we are advancing early-stage pipeline compounds and are focused on further characterizing them to identify the best clinical indications for non-clinical and clinical evaluation. Advancement of any of our product candidates to the commercialization stage is completely dependent on the outcome of clinical studies that are reviewed and approved by the FDA or other comparable regulatory authorities.

Corporate History and Structure

Headquartered in University Park, Florida, we were originally incorporated in Delaware on July 11, 2006, under the name Nu Pharmas, Inc. (“Nu Pharmas”). We initially focused on antisense RNA research and the contract manufacturing of oligonucleotides. On April 9, 2007, Nu Pharmas acquired substantially all the assets of Renaissance Nutraceuticals, Inc., a Delaware corporation, and subsequently changed its name to Amedex Therapeutics, Inc. (“Amedex Therapeutics”). On November 11, 2007, Amedex Therapeutics acquired substantially all the assets of Lakewood Pharmaceuticals, Inc., a Delaware corporation. On February 1, 2008, Amedex Therapeutics changed its name to Lakewood-Amedex Inc. On June 5, 2025, the Company changed its name to Lakewood-Amedex Biotherapeutics Inc. and redomiciled as a Nevada corporation. On September 29, 2025, the Company filed a certificate of amendment to its articles of incorporation effecting a 1-for-5.92 reverse stock split.

From 2012 to 2013, we shifted our focus toward the development of small molecule antimicrobials, particularly the Bisphosphocin^® class of molecules, which were discovered during the early oligonucleotide testing. Since 2014, we have continued to refine our research and development efforts to address the growing global issue of AMR.

Our Business Strategy

Our strategy is to leverage our deep industry expertise in infectious diseases to advance our lead compound, Nu-3, and expand the Bisphosphocin^® class of antimicrobials to treat a broad range of infections, including those affecting the skin, bladder, and lungs. We have assembled a highly experienced management team with a background in drug discovery, development, and commercialization. Our team has successfully taken compounds from early-stage development all the way to market. In addition, our team possesses strong business development and financial management expertise, supported by a Board of Directors with complementary experience in business leadership and drug development.

Our primary focus is on advancing Nu-3 gel as the lead program for treating iDFU. Beyond this, we are committed to extending the intellectual property surrounding our Bisphosphocin^® discovery and expanding our indication portfolio. We will prioritize drug development activities based on resource allocation and the commercial potential of each indication, ensuring that we maximize the impact and value of our pipeline.

Commercial Opportunity

Commercial opportunity is largely dependent on the medical need, defined as the frequency and severity of a health problem with limited available treatment options.

AMR is recognized as a growing global public health and economic threat. Increasing resistance among bacterial and fungal pathogens has reduced the effectiveness of existing antibiotics and antifungal agents, making certain infections increasingly difficult or, in some cases, impossible to treat. This trend increases the risk of disease transmission, severe illness, disability, and mortality. The World Health Organization and other public health bodies have identified AMR as a priority area for new drug development.

From an economic standpoint, the impact of AMR extends beyond healthcare systems and into broader global productivity and trade. It has been estimated that, if left unaddressed, the global economic toll of AMR could reach approximately $3.8 trillion worldwide in lost gross domestic product (GDP) by 2050.⁵ In the United States alone, treatment of infections caused by six of the most common multidrug-resistant pathogens was estimated to cost over $4.6 billion in 2021.

There is a critical and ongoing need for new antimicrobial therapies that are effective against resistant pathogens. The Bisphosphocin^® class of compounds may address this unmet medical need. The commercial opportunity for a new class of antimicrobial agents that possesses a low probability for inducing resistance is tremendous, spanning many types of infections, including skin and soft-tissue infections, urinary tract infections, and pulmonary infections. An agent that can be delivered locally to the site of infection with a low propensity for resistance and with a low risk of producing systemic side effects while delivering the active antimicrobial at a high concentration to the site of the infection is particularly attractive. The Bisphosphocin^® class has the potential to provide compounds with these properties, which have to then be confirmed in clinical studies and reviewed and approved by the FDA or other comparable regulatory authorities.

As an example of skin and soft-tissue infections, infections in diabetic foot ulcers represent a high medical need. There are approximately 830 million people worldwide suffering from diabetes,¹ with nearly 40 million in the United States alone.² About one-third of them are estimated to develop a diabetic foot ulcer (DFU) during their lifetime, with 50% of them experiencing infections at least once. The risk of complications is high; 20% of diabetic patients with foot ulcers will require amputations.² Infections, especially when left untreated, are a critical risk factor for amputations, alongside the presence of conditions like peripheral arterial disease.³ Studies show that about 15% to 20% of iDFU are caused by resistant pathogens, primarily MRSA.⁴ This underscores the need for rapid and effective treatment in the early stage, including effective elimination of resistant pathogens, to prevent disease progression and potentially devastating complications like amputations. The cost for all DFU related treatments and complications in the United States was estimated at approximately $80 billion in 2018. The Bisphosphocin^® class is amenable to formulation as a topical agent, allowing direct application to the site of infection at high concentration without relevant systemic exposure, which needs to be proven in a thorough pharmacokinetic study once the final dose and formulation have been established.

World Health Organization (WHO), Diabetes Fact Sheet (2024), available at https://www.who.int/news-room/fact-sheets/detail/diabetes.

American Diabetes Association, Statistics About Diabetes, Diabetes in America: Prevalence, Statistics, and Economic Impact.

Armstrong D., et al., Diabetes Care, 1998, 21 (5): 855-859; Oyibo S.O., et al., Diabetes Care, 2001, 24, 84-88; Jia L., et al. PLoS ONE, 2017, 12 (5): 1-15, https://doi.org/10.1371/journal.pone.

Zhou et al, The Global Prevalence of Methicillin-Resistant Staphylococcus Aureus in Patients with Diabetic Foot Ulcers: A Systematic Review and Meta-Analysis, Diabetes, Metabolic Syndrome and Obesity, 2024, 17, 563-574.

World Bank, Drug-Resistant Infections: A Threat to Our Economic Future (2017), Washington, DC: World Bank (license: Creative Commons Attribution CC BY 3.0 IGO).

Similarly, complicated urinary tract as well as pulmonary infections are of increasing global relevance. Complicated urinary tract infections and especially catheter-associated urinary tract infections (CAUTI) are frequently caused by drug resistant bacteria and bacterial biofilm. There are estimated to be approximately 600,000 CAUTI events per year in the US alone. After the placement of a catheter, the daily incidence of bacteriuria is 3-10% and between 90% and 100% of patients who undergo long-term catheterization develop bacteriuria. The estimated total U.S. cost per year for CAUTI is over $450 million. The Bisphosphocin^® class is amenable to formulation as a solution, allowing direct application to the site of infection through the catheter. This local application is expected to achieve high local concentrations in the bladder, and the Company aims to demonstrate that the use of Bisphosphocin^® class is safe in this indication and has a comparable broad-spectrum antimicrobial activity in patients, as shown consistently in vitro and nonclinical in vivo models. In addition, the potential activity against the complicating biofilm, which is viewed as the main reason for recurrent infections, will be explored first in non-clinical in vivo models, followed by a clinical trial program for that indication, which then has to be reviewed and approved by the FDA and comparable regulatory authorities.

Pulmonary infections such as community acquired bronchial pneumonia (CABP), hospital acquired bronchial pneumonia (HABP), and ventilator acquired bronchial pneumonia (VABP) are frequently caused by drug resistant bacteria. The cost of treating HAP ranges from $28,000 to $40,000 per patient, while VABP can cost between $40,000 to $60,000 per patient. The annual economic burden of HAP and VAP in the US is estimated to be over $10 billion, driven by prolonged hospital stays, increased ICU admissions, and extensive use of antibiotics and other therapeutic interventions. In addition, patients with cystic fibrosis have recurrent bacterial and fungal lung infections with organisms such as P. aeruginosa and A. fumigatus, and the occurrence of multidrug-resistant strains is a continuing problem. Inhaled delivery to the site of infection is considered optimum, and the Bisphosphocin^® class is well-suited to be formulated as an aerosol product. This will allow the company to complete the nonclinical testing of our portfolio compounds, such as Nu-8, Nu-10, and Nu-11, and provided the non-clinical data support its safe use, it is planned to file an IND with the FDA to initiate clinical testing in these pulmonary infections using a nebulizer device.

A detailed commercial assessment for the CAUTI and the pulmonary indication will be performed when the development reaches the milestone of an accepted IND and enters the clinical phase.

Our Competitive Strengths

Most drug discovery and development efforts by other companies in the infectious disease area focus on established classes of antimicrobial agents, which are vulnerable to known mechanisms of resistance. These mechanisms include target modification (e.g., peptidoglycan mutation and vancomycin resistance), direct metabolism of the agent (e.g., beta-lactamases and beta-lactam antibiotics), and efflux pump action (e.g., sdrM efflux pump mutations and fluoroquinolones). In contrast, our new class of antimicrobials, the Bisphosphocin^® class, has not shown any such susceptibility to those mechanisms of resistance in established in vitro experiments, including the appropriate controls. In these in vitro experiments designed to induce resistance, the Bisphosphocin^® class has maintained its antimicrobial activity while ciprofloxacin, which was used as a control in these experiments, became subject to resistance development. These in vitro studies need to be extended by testing the potential for resistance development in comparison to several other established antibiotics. These tests can only be performed in vitro, and this is also an established way of testing compounds that are already in clinical use. Only once an antimicrobial is approved by the FDA and other comparable regulatory authorities and is clinically used can it be determined if an antimicrobial will become subject to resistance development over time or not. This will require long-term observational studies, post-marketing surveillance, and ongoing and repeated in vitro testing. In all established in vitro and in vivo non-clinical models, the Bisphosphocin^® class has consistently demonstrated a broad spectrum of activity, being effective against gram-positive, gram-negative, and multidrug-resistant organisms. Confirmation in clinical studies would constitute a significant difference compared to most of the existing antimicrobial classes that are often selective to specific types of infectious organisms. Lastly, the local application of the Bisphosphocin^® class is expected to minimize systemic side effects, which needs to be demonstrated in clinical studies. The local drug application also allows for the use of higher drug concentrations, directly applied to the infection location.

For our lead candidate, Nu-3 gel, we believe that these three key competitive advantages, if confirmed clinically and once reviewed and approved by the FDA and other Health Authorities, will position it to potentially become a competitive and relevant component in the care of iDFU. The rationale behind this is that, if confirmed clinically, Nu-3 gel would not only exhibit the broad-spectrum activity against all regular pathogens but also against resistant pathogens like MRSA, which are not susceptible to antibiotics that are routinely used today as the Standard of Care (SOC) in patients with mildly infected DFU. The problem with this Standard of Care (SOC) practice is that about 15 – 20 percent of infected DFU also involve resistant pathogens. Until microbial testing results are available, the patients may not be receiving effective antimicrobial treatment if their iDFU is caused or involves, for example, MRSA, which may lead to clinical worsening. Nu-3, provided that the available non-clinical evidence can be confirmed in clinical use, would eliminate the dependence and need to wait for microbiological sampling and test results, and allow for immediate treatment regardless of the bacterial pathogen causing the infection. Furthermore, the existing non-clinical evidence needs to be proven, but if confirmed, it gives reason to assume that there is only a minimal concern about the emergence of resistant organisms, as the compound is designed to rapidly eradicate pathogens without showing any signs of resistance development. These same features may also be applicable to other potential uses of the Bisphosphocin^® class, such as in the treatment of urinary tract infections (UTIs) and pulmonary infections.

The Company acknowledges that the results from preclinical studies may not be reproduced in clinical trials and that the outcomes of clinical trials are inherently uncertain.

Differentiating Attributes of the Bisphosphocin^® Class

Based on the available non-clinical data, the Bisphosphocin^® class possesses three unique attributes that we believe set it apart from other antimicrobial agents. These key differentiating features, if confirmed during clinical trials and in further clinical use, and if approved by the FDA, include:

●

A novel mechanism of action is designed to enable rapid elimination of a broad spectrum of bacteria, including resistant pathogens and biofilms. Additionally, it is expected to address and prevent the common challenge of resistance emergence.

●

Direct administration to the site of infection is designed to target the infection directly.

●

Low systematic exposure is expected to minimize the risk of systemic side effects.

By 2014, the Bisphosphocin^® series had undergone extensive non-clinical characterization, with patent protection established and a lead compound advancing to an Investigational New Drug (“IND”) filing for the treatment of iDFU (IND119428). The selection of iDFU as the initial indication was based on the critical medical need and the lack of adequate treatments available.

Development Progress and Pipeline

We are advancing the Bisphosphocin^® class of antimicrobial agents through various preclinical and clinical stages, with a focus on treating infections like iDFU, while also exploring additional applications for conditions like UTIs and pulmonary infections. Below is an overview of their key progress and pipeline:

Clinical Development Progress

In 2015, as part of the regulatory requirements for pharmaceuticals that are applied directly to the skin and wounds, a Phase 1 patch (skin sensitization) study with the solution formulation at 2% concentration was performed. The study titled “A 21-DAY REPEAT INSULT PATCH TEST TO EVALUATE THE IRRITATION POTENTIAL OF ONE TEST PRODUCT (Bisphosphocin Nu-3) ON ABRADED AND INTACT SKIN SITES WITH CONTROLS” was performed in 39 healthy volunteers at BioScience Laboratories, Inc. in Montana. One mild adverse event was reported, which was assessed as not drug related (the subject pulled a shoulder muscle). In intact skin, no significant difference in skin sensitization parameters was observed when compared to the positive control. Some minimal nominal increase compared to the negative control was observed in abraded skin.

In 2016 to 2017, an exploratory Phase 1/2a study (titled: “A Phase I/IIa, Randomized Double Blind, Placebo-Controlled, Dose Escalating Study to Evaluate the Safety and Tolerability of Topically Applied Bisphosphocin™ Nu-3 on Infected Diabetic Ulcers of Subjects with Type I or II Diabetes Mellitus” and corresponding NCT02737722) in patients with iDFU using low concentrations (0.1%, 1% and 2%) of a solution formulation was conducted with full data readout in 2018. The results showed a trend of positive antimicrobial response and improved wound healing, particularly with the 2% solution.

This Phase 1/2a exploratory study was designed as a prospective, multicenter, blinded, randomized (with respect to placebo), dose-escalation, twice-daily for 7 consecutive days trial of Nu-3 solution administered topically in subjects with infected diabetic foot ulcers. A total of 30 subjects were enrolled in 3 successive cohorts (8 subjects/active treatment group) and received 0.1%, 1%, or 2% Nu-3 or placebo (6 subjects). The study enrolled patients at three sites: San Francisco, California (Center for Clinical Research); Oldsmar, Florida (Journey Research); and Franklin, Tennessee (Clinical Research Solutions).

On review of the data, some interesting trends were observed. Post-hoc analyses of the median values of the percentage area reduction from baseline showed a decrease in the size of the ulcer in the 2% Nu-3 group, which was more than twice as large as any other group (placebo, 0.1%, and 1% solution), suggesting that a 2% solution had a positive biological effect on infected diabetic foot ulcers. Consistent with this finding, for virtually all other parameters measured, the 2% cohort had a larger positive effect than placebo or the other cohorts, including the global microbiological response to the Nu-3 treatment.

In conclusion, the study drug was well tolerated. Only 1 subject experienced a treatment emergent adverse event (TEAE) during the study, including a serious adverse event (SAE) that resulted in study drug withdrawal. Both the TEAE and SAE were considered unrelated to the study drug.

This encouraging data led to the decision to switch from a solution to a gel formulation, which adheres better to the skin and wound than a solution. A gel keeps the active drug in a wound area (especially at the bottom of the foot, where many of the diabetic foot ulcers are located) for a longer time. The development of a new formulation started in 2018, and plans for the next clinical study with gel formulation and higher concentrations were planned for 2020, but fundraising had to take place first. The advent of the COVID-19 pandemic in 2020 slowed down work with external vendors, especially in India, to complete the testing with the new formulation.

A Phase 2 study in complicated DFU was initiated in March of 2022 but was halted after the FDA requested an additional wound toxicology study in large animals. The large animal study was designed with positive feedback from the FDA and included higher concentrations and a longer treatment period using the gel formulation. The large animal study was completed in early 2023 and established a high no adverse effect level (NOAEL) that supported the use of higher concentrations of the gel for up to two weeks of treatment.

A revised protocol for a full phase 2b clinical program in patients with mildly infected diabetic foot ulcers, comparing two concentrations of the gel formulation (5% and 10%), in two dosing regimens, once-a-day and twice-a-day, with a placebo control and in a double-blinded design, was discussed successfully with the FDA in 2023. More recently, the company has decided to precede that fully blinded trial with a smaller single-blinded label clinical Phase 2a study using the 2%, 5%, and 10% gels, twice a day, to establish an early proof of concept for potential use of Nu-3 gel in the target patient population and to also demonstrate a dose response. This would provide further feedback and affirmation to proceed with a follow-on Phase 2b trial utilizing the originally planned double-blind, placebo-controlled design. Lakewood-Amedex Biotherapeutics Inc. plans to conduct the open label study immediately after receiving the Series C Preferred Shares investment and the subsequent listing on Nasdaq, which is contingent on SEC and Nasdaq approval and the Series C Preferred Shares financing. The proceeds from the Series C Preferred Shares financing are expected to fund the completion of the Phase 2a study.

Our Current Pipeline for the Bisphosphocin^® Class for Additional Indications:

In addition to the lead compound Nu-3 being advanced into a Phase 2a clinical trial, Lakewood-Amedex Biotherapeutics Inc. has a number of chemically distinct compounds that are at the preclinical stage of development and that are being explored for treating different indications. Therapies for local drug delivery have to consider the specific tissue properties to identify the compound with the most favorable benefit/risk balance in the target organs. Of particular relevance is the compound identification and optimization to maintain the best antimicrobial effects without relevant local toxicity. Lakewood-Amedex Biotherapeutics Inc. is envisioning complicated Urinary Tract Infection (cUTI) and pulmonary infections as ideal targets for local drug delivery with a high medical need.

Among the cUTI infections, the large cohort of CAUTI is of particular interest and relevance. Permanent catheters lead to frequent and repeated infections after just two weeks following placement of an indwelling catheter, and the rate reaches almost 100% after a month. Many chronic conditions require the placement of such catheters permanently or intermittently (e.g., patients with Parkinson’s disease, plegic patients following stroke or trauma, bed bound patients in nursing homes), and the catheter itself becomes a venue for instillation of an antimicrobial solution.

Pulmonary infections are among the most frequent bacterial infections, often hospital acquired, which can be treated with local drug delivery at least in an early stage and also prevent progression to more severe disease. Many of these infections involve resistant bacteria such as Klebsiella pneumoniae, against which the Bisphosphocin^® class of compounds has been shown to be highly effective in in vitro experiments. The development of a pulmonary indication would need to go hand in hand with aerosol formulation development as well as the development of a delivery device (nebulizer).

For both indications, CAUTI and pulmonary infections, the goal is to move the non-clinical programs forward, conducting further profiling of the portfolio compounds Nu-8, Nu-10, and Nu-11, including the use of applicable animal models, to allow for an IND filing and entering into a first clinical phase 1 pilot study.

Important Information Regarding Recent Financing Activities

During February, March, and April 2026, Lakewood-Amedex Biotherapeutics, Inc. (the “Company”) issued a total of seven unsecured promissory notes (the “Notes”) to multiple lenders. Five of the Notes were issued in February and March 2026, each in the principal amount of $25,000. Two additional Notes were issued in April 2026 in the principal amounts of $43,158 and $30,000, respectively, for aggregate gross proceeds of $198,158.

The Notes were issued to one member of the Company’s Board of Directors, who purchased three Notes with an aggregate principal amount of $93,158; to three existing shareholders, who collectively purchased Notes totaling $75,000; and to one third-party lender, who purchased a Note in the principal amount of $30,000.

The Company issued the Notes to provide short-term working capital and to extend its cash runway through the closing of its $7.5 million financing transaction involving the issuance of Series C Convertible Preferred Stock, which closed in April 2026.

The Notes bore interest at a rate of 12% per annum, calculated on a simple interest basis using a 365-day year, commencing on the date funds are advanced. The outstanding principal and accrued but unpaid interest were due and payable on the earlier of (i) five days following the closing of the $7.5 million financing transaction or (ii) June 30, 2026 (the “Maturity Date”). The Company had the right to prepay the Notes at any time without penalty.

The Notes contained customary events of default, including (i) failure to make required payments when due (subject to specified cure periods), (ii) failure to perform material covenants, and (iii) insolvency-related events. Upon the occurrence of an event of default, the applicable lender may declare all outstanding obligations immediately due and payable. The Notes also provided for the payment of reasonable costs of collection and enforcement, including attorneys’ fees. The Notes were unsecured obligations of the Company and were governed by the laws of the State of Florida.

During April 2026, the Company repaid in full all outstanding principal and accrued interest under the Notes, and no amounts remain outstanding thereunder.

On January 31, 2026, we entered into a securities purchase agreement with an accredited investor, pursuant to which we sold, in a private placement exempt from registration provided by Rule 506(b) of the Securities Act, an aggregate of 937,500 shares of Series C Preferred Stock at a price of $10,00 per share, subject to a 20% discount. The securities purchase agreement was a binding contract for the investor, subject only to conditions outside of the investor’s control. The sole investor is an accredited investor that was introduced to the Company through RBW in August 2025.

In accordance with the securities purchase agreement, we amended our articles and filed a certificate of designation to create a new class of Series C Preferred Stock, with an authorized number of 937,500 shares, with the following terms.

The Series C Preferred Stock has a stated value of $10.00 per share and is convertible into Common Stock in an amount determined by the stated value divided by the conversion price.

The conversion price is equal to the lower of (i) $10.00 (the “Fixed Price”), or (ii) 80% of the lowest closing sale price of the Common Stock during the five consecutive trading days immediately preceding the conversion date or other date of determination (the “Variable Price”), but which Variable Price will not be lower than the floor price of $1.00 (the “Floor Price”). The conversion price will be subject to certain adjustments, including if we sell Common Stock at a price lower than the Fixed Price, and in the event of stock splits, stock dividends, and similar transactions (provided that the Fixed Price will not exceed $10.00 and the Floor Price will not exceed $1.00). The Series C Preferred Stock cannot be converted to Common Stock to the extent such conversion would cause the holder to beneficially own more than 4.99% of our outstanding Common Stock.

Holders of Series C Preferred Stock are entitled to receive, when, as and if declared by the Board of Directors, out of funds of the Company legally available therefor, monthly dividends, at the rate of $0.96 per share per year, or 9.6% of the Fixed Price of $10.00 per share, which dividends will be cumulative, and payable in cash or in kind, commencing six months after the date that the Common Stock commenced trading on Nasdaq.

In the event of any liquidation of the Company or any Deemed Liquidation Event (as defined in the articles), holders of Series C Preferred Stock are entitled to an amount per share equal to the greater of (a) the stated value; or (b) such amount per share as would have been payable had all Series C Preferred Stock been converted into Common Stock immediately prior to such event, prior to any payment with respect to the Common Stock.

We have entered into a registration rights agreement with the investor and agreed to file this registration statement for the resale of the Common Stock issuable upon conversion of the Series C Preferred Shares of our Common Stock.

Implications of Being an Emerging Growth Company and a Smaller Reporting Company

As a company with less than $1.235 billion of revenue during our last fiscal year, we qualify as an “emerging growth company” as defined in the Jumpstart Our Business Startups Act of 2012, or the JOBS Act. We may remain an emerging growth company for up to five years from the date of the closing of our public offering, or until such earlier time as we have more than $1.235 billion in annual revenue, the market value of our stock held by non-affiliates is more than $700 million as of the final day of our second fiscal quarter, in which case we would cease to be an “emerging growth company” as of the following final day of our fiscal year, or we issue more than $1 billion of non-convertible debt over a three-year period.

For so long as we remain an emerging growth company, we are permitted and intend to rely on certain exemptions from various public company reporting requirements, including not being required to include an attestation report on internal control over financial reporting issued by our independent registered public accounting firm pursuant to Section 404(b) of the Sarbanes-Oxley Act of 2002, reduced disclosure obligations regarding executive compensation in our periodic reports and proxy statements, and exemptions from the requirements of holding a nonbinding advisory vote on executive compensation and any golden parachute payments not previously approved. In addition, the JOBS Act provides that an emerging growth company can take advantage of an extended transition period for complying with new or revised accounting standards. This provision allows an emerging growth company to delay the adoption of some accounting standards until those standards would otherwise apply to private companies. We have elected to take advantage of this extended transition period under the JOBS Act. As a result, our operating results and financial statements may not be comparable to the operating results and financial statements of other companies that have adopted the new or revised accounting standards.

We are also a “smaller reporting company,” meaning that the market value of our stock held by non-affiliates is less than $700 million, and our annual revenue was less than $100 million during our most recently completed fiscal year. We may continue to be a smaller reporting company if either (i) the market value of our stock held by non-affiliates is less than $250 million measured on the last business day of our second fiscal quarter or (ii) our annual revenue is less than $100 million during the most recently completed fiscal year and the market value of our stock held by non-affiliates is less than $700 million measured on the last business day of our second fiscal quarter. If we are a smaller reporting company at the time we cease to be an emerging growth company, we may continue to rely on exemptions from certain disclosure requirements that are available to smaller reporting companies. For so long as we remain a smaller reporting company, we are permitted and intend to rely on exemptions from certain disclosure and other requirements that are applicable to other public companies that are not smaller reporting companies, such as providing only two years of audited financial statements.

Summary of Risk Factors

Below is a summary of material factors that make an investment in our securities speculative or risky. This summary may not address all of the risks and uncertainties that we face. Additional discussion of the risks and uncertainties summarized in this risk factor summary, as well as other risks and uncertainties that we face, can be found under the section titled “Risk Factors” in this prospectus. The summary below is qualified in its entirety by that more complete discussion of such risks and uncertainties. You should carefully consider the risks and uncertainties described under the section titled “Risk Factors” as part of your evaluation of an investment in our securities:

●

The successful development of biopharmaceutical products is highly uncertain, and our current product candidates have not been approved for commercial sale. We may encounter substantial delays in completing, or ultimately be unable to complete, the development and commercialization of our product candidates.

●

The regulatory approval processes of the FDA, the EMA, and other comparable foreign regulatory authorities are lengthy, time consuming, and unpredictable, and the outcome of preclinical studies or early clinical trials may not predict the success of later trials, and the results may not meet the requirements of the FDA, the EMA, or other regulatory authorities. In addition, our current or future product candidates may cause adverse events, toxicities, or undesirable side effects, which could hinder regulatory approval, market acceptance, or commercial potential.

●

Even if approved, our product candidates may not achieve adequate market acceptance among physicians, patients, healthcare payors, and others in the medical community necessary for commercial success. The sizes of the markets for our product candidates are estimates, and these markets may be smaller than estimated. In addition, we may face significant competition, and if our competitors develop superior, safer, or more cost-effective products, our commercial opportunities could be negatively impacted.

●

We rely, and expect to continue to rely, on third parties for preclinical studies, clinical trials, and manufacturing. If these third parties fail to fulfill their duties, comply with applicable regulations, or meet expected deadlines, it could delay regulatory approval or commercialization of our product candidates, harming our business.

●

Complexities in manufacturing and supply, or changes in manufacturing methods of our anti-infective and anti-microbial products, could increase costs or delay clinical trials and commercial availability.

●

Our relationships with healthcare professionals, clinical investigators, CROs, and third-party payors may be subject to healthcare fraud and abuse laws, exposing us to criminal sanctions, civil penalties, damages, exclusion from government programs, reputational harm, and financial losses. Misconduct or regulatory noncompliance by employees or third parties, including independent contractors such as contract research organizations (“CROs”), could adversely affect our business.

●

Our long-term prospects depend in part on the successful discovery and development of additional product candidates, which may fail or be delayed in development, adversely affecting their commercial viability. We may allocate our limited resources to a specific product candidate or indication and miss opportunities to pursue others that could be more profitable or more likely to succeed.

●

We may develop our current and future product candidates in combination with other therapies, which exposes us to additional risks, and certain of our product candidates are regulated as combination products.

●

If we decide to establish additional collaborations but are not able to establish those collaborations on commercially reasonable terms, we may have to alter our development and commercialization plans.

●

The FDA, the EMA, and other comparable foreign regulatory authorities may not accept data from trials conducted in locations outside of their jurisdiction. Obtaining and maintaining regulatory approval of our product candidates in one jurisdiction does not mean that we will be successful in obtaining regulatory approval of our product candidates in other jurisdictions.

●

The FDA and other regulatory agencies enforce laws and regulations prohibiting the promotion of off-label uses, and we may face difficulties from changes to current regulations and future legislation.

●

If we fail to comply with environmental, health, and safety laws and regulations, we could become subject to fines or penalties or incur costs that could have a material adverse effect on our business.

●

We have never commercialized anti-infective pharmaceuticals before and may lack the necessary expertise, personnel, and resources to successfully commercialize any product candidates. In addition, any product candidates we develop may become subject to unfavorable third-party coverage and reimbursement practices, as well as pricing regulations

●

Our business entails a significant risk of product liability, and if we are unable to obtain sufficient insurance coverage, such inability could have an adverse effect on our business and financial condition.

●

Our success depends on our ability to protect our intellectual property and our proprietary technologies. Patent terms may not provide sufficient protection for our competitive position on product candidates, and if we do not obtain patent term extension for our product candidates, our business may be materially harmed.

●

Intellectual property disputes, including derivation proceedings and litigation, may result in loss of rights, require us to seek licenses from third parties, or lead to reputational harm that could harm our business and stock price.

●

We may not identify relevant third-party patents or may misinterpret their relevance, scope, or expiration, which might adversely affect our ability to develop and market our product candidates, or we may be subject to claims that our employees, consultants, or independent contractors have wrongfully used or disclosed confidential information of third parties.

●

Some of our future intellectual property may result from government-funded programs and therefore be subject to federal regulations, including reporting requirements and U.S. manufacturing preferences. These obligations could limit our exclusive rights and restrict our ability to engage non-U.S. manufacturers.

●

We may not be able to protect our intellectual property rights throughout the world, and if our trademarks and trade names are not adequately protected, then we may not be able to build name recognition in our markets of interest, and our business may be adversely affected.

●

We may need to raise additional capital, which may not be available on favorable terms, if at all, potentially causing dilution to stockholders, restricting our operations, or adversely affecting our business.

●

We will incur increased costs as a result of operating as a public company, and our management will be required to devote substantial time to new compliance initiatives. We will be subject to financial reporting and other requirements for which our systems and resources may not be adequately prepared.

●

There can be no assurance that the Company will be able to comply with the continued listing standards of Nasdaq. If we cannot meet the continued listing requirements of Nasdaq, Nasdaq may delist our securities.

●

Reports published by analysts, including projections in those reports that differ from our actual results, could adversely affect the price and trading volume of our common stock.

●

You may be diluted by future issuances of preferred stock or additional common stock in connection with our incentive plans, acquisitions, or otherwise; future sales of such shares in the public market, or the expectations that such sales may occur, could lower our stock price.

●

Our internal computer systems, or those of our CROs, manufacturers, contractors, consultants, collaborators, or potential collaborators, may fail or experience security or data privacy breaches. Such incidents could lead to increased costs, revenue loss, significant liabilities, reputational harm, and material operational disruptions.

●

Our operations are vulnerable to disruptions from fire, severe weather, power outages, telecommunications failures, terrorist acts, and other uncontrollable events, which could negatively impact our business.

Corporate Information

Our corporate address is 8031 Cooper Creek Blvd., Unit 103, University Park, Florida 34201, and our telephone number is (941) 225-2515. Our website can be found at lakewoodamedex.com. The information contained on our website is not a part of this prospectus, nor is such content incorporated by reference herein, and should not be relied upon in determining whether to make an investment in our shares of common stock.

SUMMARY HISTORICAL FINANCIAL AND OTHER DATA

The following tables set forth our summary of historical financial data for the years ended December 31, 2025 and 2024.

The summary statements of operations data for the years ended December 31, 2025 and 2024 are derived from our audited financial statements and notes that are included elsewhere in this prospectus.

We have prepared the audited financial statements in accordance with the U.S. generally accepted accounting principles (“GAAP”). Our historical results are not necessarily indicative of our results in any future period.

Statement of Operations

	For the Years Ended December 31,
	2025			2024
Statement of Operations Data:
Revenue	$	—		$	—
Operating expenses:
Research and development		1,255,266			2,103,366
General and administrative		2,512,470			1,917,154
Depreciation		4,634			6,300
Total operating expenses		3,772,370			4,026,820
Loss from operations		(3,772,370	)		(4,026,820	)
Other income (expense):
Interest income		25,614			142,596
Realized loss on investment		—			(722	)
Loss on fraud incident		—			(1,042,459	)
Interest expense		(100,881	)		(5,000	)
Other income		—			77,000
Total other income (expense), net		(75,267	)		(828,585	)
Net loss	$	(3,847,637	)	$	(4,855,405	)

	For the Years Ended December 31,
	2025			2024
Statement of Cash Flows Data:
Cash Flows From Operating Activities	$	(1,944,698	)	$	(5,723,322	)
Cash Flows From Investing Activities		—			3,924,664
Cash Flows From Financing Activities		1,500,000			(50,000	)
Cash, End of Period		236,400			681,098

	As of December 31,
	2025			2024
Balance Sheet Data:
Total assets	$	481,598		$	1,070,581
Total liabilities		2,446,135			660,970
Total stockholders’ equity (deficit)		(1,964,537	)		409,611

RISK FACTORS

An investment in our common stock involves a high degree of risk. You should carefully consider the following risks and all of the other information contained in this prospectus before deciding whether to invest in our common stock. If any of the following risks are realized, our business, financial condition, and results of operations could be materially and adversely affected. In that event, the trading price of our common stock could decline, and you could lose all or part of your investment in our common stock. Additional risks of which we are not presently aware, or that we currently believe are immaterial, may also harm our business and results of operations. Some statements in this prospectus, including such statements in the following risk factors, constitute forward-looking statements. See the section entitled “Cautionary Note Regarding Forward-Looking Statements.”

The successful development of biopharmaceutical products is highly uncertain.

Successful development of biopharmaceutical products is highly uncertain and depends on numerous factors, many of which are beyond our control. Product candidates that appear promising in the early phases of development may fail to reach the market due to clinical trial results showing insufficient efficacy (e.g., failure to meet primary or key secondary endpoints) or unacceptable safety or tolerability profiles. Development may also be delayed or halted due to failure to obtain regulatory approvals or delays caused by slow enrollment, high dropout rates, lengthy timeframes to achieve endpoints, extended data analysis, additional FDA data requests, or manufacturing or safety issues. Preclinical results may reveal harmful side effects or inadequate efficacy, and post-marketing requirements or competing proprietary technologies may also hinder commercialization.

Even if we are successful in obtaining marketing approval, commercial success of approved products may also depend in large part on the availability of coverage and adequate reimbursement from third-party payors, including government payors such as the Medicare and Medicaid programs and managed care organizations in the United States or country-specific governmental organizations in foreign countries, which may be affected by existing and future healthcare reform measures designed to reduce the cost of healthcare. Third-party payors could require us to conduct additional studies, including post-marketing studies related to the cost effectiveness of an approved product, to qualify for reimbursement, which could be costly and divert our resources. If government and other healthcare payors were to not provide coverage and adequate reimbursement for our products once approved, market acceptance and commercial success may be reduced. In addition, if any of our product candidates receive marketing approval, we will be subject to significant regulatory obligations regarding the submission of safety and other post-marketing information and reports and registration and will need to continue to comply (or ensure that any third-party providers comply) with current good manufacturing practices, good clinical practices, or good clinical practices for any clinical trials that we conduct post-approval. In addition, there is always the risk that we, a regulatory authority, or a third party might identify previously unknown problems with a product post-approval, such as adverse events of unanticipated severity or frequency. Compliance with these requirements is costly, and any failure to comply or other issues with our product candidates post-approval could adversely affect our business, financial condition, and results of operations.

We have a limited operating history, and none of our current product candidates have been approved for commercial sale, which may make it difficult for you to evaluate our current business and predict our future success.

Biopharmaceutical product development is a highly speculative undertaking and involves a substantial degree of risk. We are at the clinical stage for the development of an anti-infective pharmaceutical company with a limited operating history upon which you can evaluate our business and prospects. None of our current product candidates is approved for commercial sale, and we have not generated any revenue from them. To date, we have primarily focused our resources on company formation, business planning, partnerships, capital raising, R&D, securing intellectual property, and conducting preclinical and clinical studies. As a result, it may be more difficult for you to accurately predict our future success or viability. In addition, we may encounter unforeseen expenses, difficulties, complications, delays, and other known and unknown factors frequently experienced by clinical-stage biopharmaceutical companies. We may also need to transition from a company with a research focus to a company capable of supporting commercial activities. If we do not adequately address these risks or successfully make such a transition, our business will suffer.

We will need to raise additional capital, which may not be available on favorable terms, if at all, potentially causing dilution to stockholders, restricting our operations, or adversely affecting our business.

Developing biopharmaceutical products is a time-consuming, expensive, and uncertain process that takes years to complete. Our operations have required substantial cash since inception, and we expect expenses to increase as we advance clinical trials and seek regulatory approvals for our current and future product candidates. Even if one or more of our product candidates are approved for commercial sale, we anticipate incurring significant costs associated with commercializing any approved product candidate. Expenses may exceed expectations if regulatory authorities such as the FDA or EMA require additional studies beyond our current plans. Other unforeseen costs may also arise. Given the uncertainty in trial design and outcomes, we cannot accurately estimate the total funding needed to complete development and commercialization. Accordingly, we will need to obtain substantial additional funding in order to maintain our continuing operations.

Our estimate as to how long our existing capital will fund our operations is based on assumptions that may prove to be wrong, and we could use our available capital resources sooner than we currently expect. Changing circumstances, including factors beyond our control, could lead us to use capital more quickly than anticipated, requiring us to seek additional funding earlier than planned. Our future funding requirements will depend on many factors, including, but not limited to the following: the initiation, progress, timing, cost, and outcomes of clinical trials and preclinical studies; the advancement of our pipeline and research programs; manufacturing costs, including scale-up activities; potential program expansions for new indications; regulatory requirements and their timing and cost; expenses related to intellectual property protection; competitive developments; licensing, royalty, and milestone payments; general operating expenses; costs to establish sales, marketing, and distribution infrastructure for any approved products; and the ongoing expenses of operating as a public company.

Advancing the development of our product candidates will require a significant amount of capital. In order to fund all of the activities that are necessary to complete the development of our product candidates, we will be required to obtain further funding through equity offerings, debt financings, collaborations and licensing arrangements, or other sources, which may dilute our stockholders or restrict our operating activities. Adequate additional funding may not be available to us on acceptable terms, or at all. Our failure to raise capital would have a negative impact on our financial condition and our ability to pursue our business strategy, and we may have to delay, reduce the scope of, suspend or eliminate one or more of our research-stage programs, clinical trials or future commercialization efforts, grant rights to develop and market product candidates that we would otherwise prefer to develop and market ourselves, obtain funds through arrangement with collaborators on terms unfavorable to us or pursue merger or acquisition strategies, all of which could adversely affect the holdings or the rights of our stockholders.

In addition, we may seek additional capital through equity, debt financing, or strategic collaborations, even if current funds appear sufficient. This may include up-front or milestone payments from strategic collaborations. To the extent that we raise additional capital through the sale of equity or convertible debt securities, your ownership interest will be diluted, and the terms may include liquidation or other preferences and anti-dilution protections that adversely affect your rights as a stockholder. Such financing may also result in the imposition of debt covenants, increased fixed payment obligations, or other restrictions that may adversely affect our ability to conduct our business. If we raise additional funds through collaborations, strategic alliances, or marketing, distribution, or licensing arrangements with third parties, we may have to relinquish valuable rights to our technologies, future revenue streams, research programs, or product candidates, or grant licenses on terms that are not favorable to us.

Risks Related to Development, Regulatory Approval, and Commercialization

The regulatory approval processes of the FDA, the EMA, and other comparable foreign regulatory authorities are lengthy, time consuming, and unpredictable. If we are ultimately unable to obtain regulatory approval for our product candidates, we will be unable to generate product revenue, and our business will be substantially harmed.

Our product candidates are subject to extensive government regulation throughout all stages of development, including research, testing, manufacturing, safety, efficacy, approval, labeling, marketing, and distribution. Rigorous preclinical studies and clinical trials, and an extensive regulatory approval process must be successfully completed in the United States and in many foreign jurisdictions before a new drug can be marketed. We are not permitted to commercialize any product candidate in the United States without obtaining marketing approval from the FDA. Foreign regulatory authorities, such as the EMA, impose similar requirements. Obtaining such approvals is unpredictable, often takes years after clinical trials begin, and depends on factors such as the type, complexity, and novelty of the product. In addition, approval policies, regulations, or the type and amount of clinical data necessary to gain approval may change during product development and may vary among jurisdictions, potentially delaying or preventing approval. Regulatory authorities have substantial discretion in the approval process and may refuse to accept any application or may decide that our data is insufficient for approval and require additional preclinical, clinical, or other data. Even if we eventually complete clinical testing and receive approval, our product candidates may be limited to narrower uses than requested. We cannot provide any assurance that any product candidate we may develop will progress through required clinical testing and obtain the regulatory approvals necessary for us to begin selling them. We have not yet submitted or obtained approval for any product candidate, and it is possible that none of our current or future candidates will ever be approved.

Further, the development of our product candidates and/or regulatory approval may be delayed for reasons beyond our control. Regulatory applications could be denied for many reasons, including the following:

●

Regulatory authorities such as the FDA or EMA may disagree with our clinical trial design, execution, or results, or may conclude that our product candidates are unsafe, only moderately effective, or have side effects or toxicities that prevent approval or limit commercial use;

●

Trial populations may not be sufficiently broad or representative enough to support approval;

●

Regulatory authorities may disagree with our interpretation of data from preclinical or clinical studies;

●

Data from our clinical trials may be insufficient to support the submission of a New Drug Application, or NDA, or other regulatory submission for approval in the U.S. or other regions;

●

We may be unable to show regulatory authorities that a product candidate’s risk-benefit ratio is acceptable for its intended use;

●

Regulatory authorities may not approve our manufacturing processes, testing procedures, specifications, or facilities, including those of third-party manufacturers for clinical and commercial supplies; and

●

Changes in regulatory policies or regulations may render our clinical data insufficient for approval.

The lengthy and unpredictable approval process, along with the uncertainty of clinical trial results, may prevent us from obtaining regulatory approval for any product candidates, significantly harming our business and prospects. Additionally, changes in regulatory policies or new regulations could delay approval of our future candidates, impose additional compliance requirements, or restrict our ability to maintain marketing authorizations.

We may encounter substantial delays in completing, or ultimately be unable to complete, the development and commercialization of our product candidates.

Before we can obtain marketing approval from the FDA, EMA, or other foreign regulators, we must complete preclinical studies and extensive clinical trials to demonstrate safety and efficacy. Clinical testing is expensive, difficult to design and implement, time-consuming, and its ultimate outcome is uncertain. A failure of one or more clinical trials can occur at any stage of the process, and results from preclinical or early-stage trials may not predict success in later phases. Clinical trials can be delayed for a variety of reasons, including delays related to:

●

Disagreements with regulatory authorities (e.g., FDA, EMA) over trial design or implementation;

●

Delays in securing regulatory approval or agreement on trial design;

●

Delays in finalizing agreements with CROs or clinical trial sites due to complex or varying terms;

●

Obtaining approval from one or more independent institutional review boards, or IRBs;

●

Delays in enrollment due to travel or quarantine policies, or other uncontrollable events;

●

Changes to clinical trial protocol;

●

Clinical sites deviating from trial protocol or dropping out of a trial;

●

Delays in manufacturing sufficient quantities of a product candidate or obtaining enough combination therapies for clinical trial use;

●

Subjects not enrolling, dropping out, or failing to return for post-treatment follow-up at expected rates;

●

Lack of adequate funding to continue the clinical trial;

●

Subjects experiencing severe or unexpected drug-related adverse effects;

●

A drug safety management board or DSMB may recommend protocol changes or early termination;

●

Occurrence of serious adverse events in trials of the same class of agents conducted by other companies;

●

Selection of clinical endpoints requiring extended observation or data analysis;

●

A manufacturing facility being ordered to shut down by regulatory authorities due to cGMP violations, or issues like infections or cross-contamination;

●

Third-party clinical investigators losing necessary licenses or failing to conduct trials on schedule or in compliance with protocols, GCP, or regulatory requirements;

●

Third-party contractors not performing data collection or analysis in a timely or accurate manner; and

●

Third-party contractors being debarred or penalized by regulatory authorities, requiring us to find substitutes and potentially invalidating their data for marketing applications;

Conducting clinical trials in foreign countries, as we may do for our product candidates, presents additional risks that may delay completion of our clinical trials. These risks include the failure of enrolled patients in foreign countries to adhere to clinical protocol as a result of differences in healthcare services or cultural customs, managing additional administrative burdens associated with foreign regulatory schemes, as well as political and economic risks relevant to such foreign countries.

Additionally, if the results of our clinical trials are inconclusive or if safety concerns or serious adverse events arise, we may face delays in obtaining marketing approval, receive approval for narrower indications or patient populations than desired, or face approval with significant restrictions, safety warnings, or additional post-marketing testing. We could also be required to include warnings or contraindications on labeling, face legal action, or suffer damage to our reputation. Delays in testing or obtaining marketing approvals will increase our development costs. We cannot predict if our preclinical studies or clinical trials will start as planned, be restructured, or be completed on schedule. Any delays or termination of trials will push back NDA submissions to the FDA or similar regulatory authorities, hindering our ability to commercialize and generate revenue. Even if trials are completed on time, we cannot guarantee the results will support our claims of differentiation, effectiveness, or safety. The FDA has broad discretion and may disagree that our data support our proposed claims.

Moreover, principal investigators for our clinical trials may serve as scientific advisors or consultants to us and receive compensation in connection with such services. Under certain circumstances, we may need to report these relationships to regulatory authorities like the FDA or EMA. If authorities determine that a financial relationship creates a conflict of interest, they may question the integrity of the data and jeopardize the trial’s validity. This could result in delays, rejection, or denial of marketing approval for our product candidates.

Delays or termination of our clinical trials would harm the commercial prospects of our product candidates and delay our ability to generate revenue. These delays would also increase costs, slow development and approval, and jeopardize our ability to start product sales. In addition, many of the factors that cause, or lead to, termination or suspension of, or a delay in the commencement or completion of, factors leading to trial delays or termination could result in regulatory approval denial of a product candidate. Such delays may reduce the period of exclusivity for commercialization, allowing competitors to bring similar products to market first, further harming the commercial viability of our product candidates and our business.

The outcome of preclinical studies or early clinical trials may not predict the success of later trials, and the results may not meet the requirements of the FDA, the EMA, or other regulatory authorities.

Positive results from preclinical studies and early clinical trials do not mean that future clinical trials will be successful. Failure can occur at any time during the clinical trial process. We do not know whether any of our product candidates will perform in current or future clinical trials as they have performed in preclinical studies and early clinical trials. Product candidates in later-stage clinical trials may fail to demonstrate sufficient safety and efficacy to the satisfaction of the FDA, the EMA, and other comparable foreign regulatory authorities despite having progressed through preclinical studies and early-stage clinical trials.

In some instances, there can be significant variability in safety and efficacy results between different clinical trials of the same product candidate due to numerous factors, including changes in trial protocols, differences in size and type of the patient populations, differences in adherence to the dosing regimen and other trial protocols, and the rate of dropout among clinical trial participants. Patients treated with our product candidates may also be undergoing surgical, radiation, and chemotherapy treatments and may be using other approved products or investigational new drugs, which can cause side effects or adverse events that are unrelated to our product candidate. As a result, assessments of efficacy can vary widely for a particular patient, and from patient to patient and site to site within a clinical trial. This subjectivity can increase the uncertainty of, and adversely impact, our clinical trial outcomes. We do not know whether any clinical trials we may conduct will demonstrate consistent or adequate efficacy and safety sufficient to obtain marketing approval to market our product candidates. Most product candidates that begin clinical trials are never approved by regulatory authorities for commercialization.

Additionally, some of our planned clinical trials may utilize an “open-label” or “single-blinded” trial design. An “open-label” clinical trial is one where both the patient and investigator know whether the patient is receiving either the investigational product candidate or an existing approved pharmaceutical or placebo. In a single-blinded trial, the patient does not know which dose is applied. Most typically, open-label as well as single-blinded clinical trials test only the investigational product candidate and sometimes may do so at different dose levels. Both open-label and single-blinded clinical trials are subject to various limitations that may exaggerate any therapeutic effect, as patients in open-label clinical trials are aware when they are receiving treatment. Open-label clinical trials may be subject to a “patient bias” where patients perceive their symptoms to have improved merely due to their awareness of receiving an experimental treatment. In addition, open-label clinical trials may be subject to an “investigator bias” where those assessing and reviewing the physiological outcomes of the clinical trials are aware of which patients have received treatment and may interpret the information of the treated group more favorably, given this knowledge. The results from an open-label trial may not be predictive of future clinical trial results with any of our product candidates, for which we include an open-label clinical trial when studied in a controlled environment with a placebo or active control.

In a single-blinded clinical trial, the investigator is aware of the type of treatment and dosing. These designs are vulnerable to an “investigator bias” in which beliefs and expectations of the investigator can influence the interpretation of observations and hence falsely influence a trial outcome. In addition, the investigator’s knowledge of the treatment and the respective beliefs and expectations may carry over to the patients and influence the true perception of, for example, adverse events.

Moreover, preclinical and clinical data are often susceptible to varying interpretations, and many companies with positive trial results have still failed to obtain regulatory approval. We cannot guarantee that the FDA, the EMA, or other regulatory authorities will interpret our results favorably, and additional trials may be required. This is particularly true for clinical trials in rare diseases, where the small patient population makes traditional trials challenging and regulatory flexibility is often needed. If the results do not meet regulatory standards, we may need to conduct more trials, which could require significant resources. Even if approval is granted, the terms may limit the scope of use and commercial potential. Additionally, changes in regulatory policies could render our clinical data insufficient, delaying or denying approval.

Interim, topline, and preliminary data from our clinical trials may change as more patient data becomes available and undergoes audit and verification, potentially leading to material changes in the final results.

We may periodically disclose interim, preliminary, or topline data from our preclinical studies or clinical trials based on the available data at the time. However, these results are subject to change following further analysis, and the final data could differ significantly due to additional data review, assumptions, or verification. As such, interim and preliminary results should be viewed with caution until final data is available. Differences between preliminary and final data may impact our business prospects. Moreover, regulatory agencies or others may not agree with our assumptions, calculations, or conclusions, which could affect the program’s value, approval, or commercialization. The information we disclose may not always align with what others consider material, and if preliminary data diverges from actual results or regulatory interpretation, our ability to obtain approval and commercialize our product candidates could be jeopardized, impacting our business, results, and prospects.

Our current or future product candidates may cause adverse events, toxicities, or undesirable side effects, either alone or in combination with other drugs. These issues could hinder regulatory approval, market acceptance, and commercial potential, or lead to significant negative consequences.

As with most biopharmaceuticals, our product candidates may cause side effects or adverse events. If clinical trial results reveal unacceptable severity or prevalence of these side effects, we may need to delay or halt trials, face a restrictive label, or experience delays or denials of regulatory approval. Adverse events could also affect patient recruitment, retention, or lead to product liability claims, which could harm our business and prospects. If our product candidates show undesirable side effects or unexpected characteristics, we may need to limit their development to specific populations or conditions where the risks are more acceptable. Adverse side effects may also impact the recruitment and retention of patients and could lead to trial termination or abandonment. Any of these occurrences may prevent us from achieving or maintaining market acceptance of the affected product candidate and may harm our business, financial condition, and prospects significantly.

If significant adverse events or other side effects are observed in any of our current or future clinical trials, we may have difficulty recruiting patients to the clinical trials, patients may drop out of our trials, or we may be required to abandon the trials or our development efforts of that product candidate altogether. Even if a product candidate is approved, the emergence of new side effects could lead to serious regulatory consequences. These include adoption of a Risk Evaluation and Mitigation Strategy (REMS), additional labeling requirements, restricted access, post-marketing studies, or even market withdrawal. We could also face penalties, lawsuits, or reputational damage. Any of these outcomes could limit commercial potential, reduce product usage, and prevent us from achieving or maintaining market acceptance. Any of these events could diminish the usage or otherwise limit the commercial success of our product candidates and prevent us from achieving or maintaining market acceptance of the affected product candidate, if approved by applicable regulatory authorities.

Even if approved, our product candidates may not achieve adequate market acceptance among physicians, patients, healthcare payors, and others in the medical community necessary for commercial success.

Even if our product candidates receive regulatory approval, they may not achieve adequate market acceptance among physicians, patients, healthcare payors, or others in the medical community. Market acceptance will depend on various factors, including: demonstrated efficacy and safety relative to existing treatments; timing of launch versus competing products; approved indications; any restrictions such as boxed warnings, contraindications, or REMS not required of alternatives; perceived advantages over current therapies; cost and pricing relative to alternatives; coverage and reimbursement by payors; ease of administration; willingness of patients and physicians to adopt new treatments; the effectiveness of our marketing efforts; public perception and media coverage; and the emergence of new competing therapies. If any of our product candidates is approved but does not achieve an adequate level of acceptance, we may not generate sufficient revenue from that product candidate, and our financial results could be negatively impacted.

Refrigerated product candidates require specific storage, handling, and administration at the clinical sites.

Our products may require refrigeration or need to be stored at low temperatures in specialized refrigerated containers until immediately prior to use. The handling, warming, and administration of the antimicrobial product would need to be performed according to specific instructions. Failure to properly store, prepare, or administer them according to instructions could compromise their safety or efficacy.

We may develop our current and future product candidates in combination with one or more other approved or unapproved therapies. We may also develop certain product candidates as biologic/drug combination products. These combination approaches may require additional development time and regulatory coordination, particularly within the FDA and comparable foreign agencies. Although the FDA and similar foreign regulatory agencies have systems in place for the review of combination products, we may experience delays in the development and commercialization of our product candidates due to regulatory timing constraints and uncertainties in the approval process.

In addition, even if any product candidate were to receive marketing approval or be commercialized for use in combination, we would continue to face risks that the FDA, the EMA, or comparable foreign regulatory authorities could revoke approval of the therapy used in combination with our product or that safety, efficacy, manufacturing or supply issues could arise with any of those existing therapies. Changes in the standard of care may also require us to conduct additional trials. The occurrence of any of these risks could result in our own product candidates, if approved, being removed from the market or being less successful commercially.

We will not be able to market and sell our product candidates that we develop in combination with an unapproved therapy for a combination indication if that unapproved therapy does not ultimately obtain marketing approval either alone or in combination with our product candidate. Unapproved therapies face the same risks described with respect to our product candidates currently in development and clinical trials, including the potential for serious adverse effects, delay in their clinical trials, and lack of FDA approval. If these therapies are not approved or later face regulatory issues, we may be unable to obtain approval or commercialize our combination products.

We may allocate our limited resources to a specific product candidate or indication and miss opportunities to pursue others that could be more profitable or more likely to succeed.

Because we have limited financial and managerial resources, we focus on research programs, therapeutic platforms, and product candidates that we identify for specific indications. As a result, we may forego or delay the pursuit of opportunities with other therapeutic platforms or product candidates or for other indications that later prove to have greater commercial potential or a greater likelihood of success. Our resource allocation decisions may cause us to fail to capitalize on viable commercial products or profitable market opportunities. Our spending on current and future research and development programs, therapeutic platforms, and product candidates for specific indications may not yield any commercially viable products. If we do not accurately evaluate the commercial potential or target market for a particular product candidate, we may relinquish valuable rights to that product candidate through collaboration, licensing, or other royalty arrangements in cases in which it would have been more advantageous for us to retain sole development and commercialization rights.

Risks Related to Our Business

The sizes of the markets for our product candidates are estimates, and these markets may be smaller than estimated.

The estimates in this prospectus of the annual addressable markets for our product candidates are based on a number of third-party estimates. While we believe the assumptions and the data underlying the estimates are reasonable, these assumptions and estimates may not be correct, and the conditions supporting the assumptions or estimates may change at any time, thereby reducing the predictive accuracy of these underlying factors. As a result, the estimates of the annual addressable market for our product candidates may prove to be incorrect.

Our future operating results are dependent on our ability to successfully discover, develop, obtain regulatory approval for, and commercialize product candidates beyond those we currently have in clinical development. A product candidate can unexpectedly fail at any stage of preclinical or clinical development. The historical failure rate for product candidates is high due to risks relating to safety, efficacy, clinical execution, changing standards of medical care, and other unpredictable variables. The results from preclinical studies or early clinical trials of a product candidate may not be predictive of the results that will be obtained in later stage clinical trials of the product candidate.

The success of our future product candidates depends on several factors, including: generating sufficient data to support clinical trials; obtaining regulatory permission to initiate clinical trials; contracting with the necessary parties to conduct clinical trials; successful enrollment of patients in, and the completion of, clinical trials on a timely basis; the timely manufacture of sufficient quantities of the product candidate and other key materials needed for use in clinical trials; and adverse events in the clinical trials. Even if we successfully advance any other product candidates into clinical development, their success will be subject to all of the clinical, regulatory, and commercial risks described elsewhere in this “Risk Factors” section. Accordingly, we cannot assure you that we will ever be able to discover, develop, obtain regulatory approval of, commercialize, or generate significant revenue from our product candidates.

We have never commercialized anti-infective pharmaceuticals before and may lack the necessary expertise, personnel, and resources to successfully commercialize any product candidates.

We have no experience commercializing anti-infective pharmaceuticals and currently lack a sales force, marketing, or distribution capabilities. To achieve commercial success for our current product candidates, we will rely on the assistance and guidance of those collaborators. For any approved product candidates for which we retain commercialization rights, we will have to develop our own sales and marketing organization or outsource these activities to a third party or enter into a formal partnership agreement with an established pharmaceutical entity.

Our ability to commercialize product candidates depends on factors like recruiting sales and marketing personnel, gaining physician access, and managing the costs of building a sales organization. Developing these capabilities will be expensive and time-consuming and could delay the launch of our product candidates, if approved. If we are unable to build our own distribution and marketing capabilities or to find suitable partners for the commercialization of our product candidates, we may not generate revenues from them or be able to reach or sustain profitability.

We may face significant competition, and if our competitors develop superior, safer, or more cost-effective products, our commercial opportunities could be negatively impacted.

Biotechnology and pharmaceutical industries are characterized by rapidly advancing technologies, intense competition, and a strong emphasis on proprietary and novel products and product candidates. Our competitors have developed, are developing, or may develop products, product candidates, and processes competitive with our product candidates. Our product candidates will compete with existing therapies and new therapies that may become available in the future. We believe that a small number of products are currently under development and may become commercially available in the future, for the treatment of conditions for which we may attempt to develop product candidates. See “Business — Competition” for additional details. Our products may also need to compete with off-label drugs used for similar indications, making it difficult to replace existing therapies with our products.

Many of our current and potential competitors, especially large pharmaceutical and biotechnology companies, have significantly greater financial, manufacturing, marketing, drug development, technical, and human resources, and commercial expertise than we do. These companies have extensive experience in clinical testing, regulatory approvals, patient recruitment, and product manufacturing. Established pharmaceutical and biotechnology companies may also invest heavily to accelerate the discovery and development of novel compounds or to in-license novel compounds that could make the product candidates that we develop obsolete. Smaller companies, particularly those with strong partnerships, could also pose significant competition. As a result, our competitors may succeed in obtaining approval and commercializing products in our field before we do.

Our commercial opportunity could be diminished if our competitors develop and commercialize products that are safer, more effective, have fewer or less severe effects, are more convenient, have a broader label, are marketed more effectively, are reimbursed, or are less expensive than any product candidates that we may develop. They may also obtain marketing approval for their products more rapidly than we may obtain approval for ours, which could result in them establishing a strong market position before we are able to enter the market. Even if the product candidates achieve marketing approval, they may be priced at a significant premium over competitive products. Technological advances by competitors could render our products obsolete or less viable. If we cannot compete effectively, our ability to generate revenue could be negatively impacted.

As a public company, and particularly after we are no longer an emerging growth company, we will incur significant legal, accounting, and other expenses that we did not incur as a private company. In addition, the federal securities laws, including the Sarbanes-Oxley Act, the Dodd-Frank Wall Street Reform and Consumer Protection Act of 2010, and rules and regulations subsequently implemented by the SEC and Nasdaq, have imposed various requirements on public companies, including requirements to file annual, quarterly, and event driven reports with respect to their business and financial condition, and to establish and maintain effective disclosure and financial controls and corporate governance practices. These rules and regulations will increase our legal and financial compliance costs, make certain activities more time-consuming and costly, and require our management and other personnel to devote a substantial amount of time to compliance initiatives. Despite our best efforts, we may not be able to produce reliable financial statements or file such financial statements as part of a periodic report in a timely manner with the SEC or comply with Nasdaq listing requirements. We also expect that these rules and regulations may make it more difficult and more expensive for us to obtain director and officer liability insurance.

Pursuant to Section 404 of the Sarbanes-Oxley Act, we will be required to furnish a report by our management on our internal control over financial reporting, including an attestation report on internal control over financial reporting issued by our independent registered public accounting firm, beginning with the first full year after we become a public company. However, while we remain an emerging growth company, we will not be required to include an attestation report on internal control over financial reporting issued by our independent registered public accounting firm. To achieve compliance with Section 404 of the Sarbanes-Oxley Act, we will be engaged in a process to document and evaluate our internal control over financial reporting, which is both costly and challenging. We will need to continue to dedicate internal resources, potentially engage outside consultants, adopt a detailed work plan to assess and document the adequacy of internal control over financial reporting, continue steps to improve control processes as appropriate, validate through testing that controls are functioning as documented, and implement a continuous reporting and improvement process for internal control over financial reporting. Despite our efforts, there is a risk that neither we nor our independent registered public accounting firm will be able to conclude within the prescribed timeframe that our internal control over financial reporting is effective as required by Section 404 of the Sarbanes-Oxley Act. This could result in an adverse reaction in the financial markets due to a loss of confidence in the reliability of our financial statements. We could also become subject to investigations by the SEC or other regulatory authorities, which could require additional financial and management resources.

As a public company, we are required to maintain disclosure controls and procedures. Disclosure controls and procedures mean our controls and other procedures that are designed to ensure that information required to be disclosed by us in the reports that we file or submit under the Exchange Act is recorded, processed, summarized, and reported, within the time periods specified in the rules and forms of the SEC. We do not expect that our disclosure controls and procedures or our internal control over financial reporting will prevent or detect all errors and all fraud. We believe a control system, no matter how well-designed and operated, can provide only reasonable, not absolute, assurance that the control system’s objectives will be met. Due to the inherent limitations in all control systems, no evaluation of controls can provide absolute assurance that misstatements due to error or fraud will not occur or that all control issues and instances of fraud, if any, have been detected. The design of any system of controls is based in part on certain assumptions about the likelihood of future events, and any design may not succeed in achieving its stated goals under all potential future conditions. Accordingly, because of the inherent limitations in our control system, misstatements due to error or fraud may occur and not be detected.

We have identified material weaknesses in its internal controls over financial reporting, The material weaknesses identified include the following: (i) the Company’s documentation of its system of internal controls (including specific control policies and procedures) is limited, (ii) Segregation of duties in the handling of cash, cash receipts, and cash disbursements is limited primarily based on the small number of employees that comprise the Company’s workforce, (iii) Lack of adequate management review controls over significant accounting areas, including calculations of investments, earnings per share, stock-based compensation, income tax provision, and ROU lease schedules, and (iv) Information technology general controls are not designed and operating effectively to ensure that access to applications and data were adequately restricted to appropriate personnel, ensure segregation of duties, and appropriately monitor the activities of the individuals with access to modify data.

Neither the Company nor its independent registered public accounting firm undertook a comprehensive assessment of its internal control under the Sarbanes-Oxley Act for purposes of identifying and reporting any material weakness in its internal control over financial reporting. The Company is required to do so only after it becomes a public company and it is exempt from the auditor attestation requirements as long as it is an emerging growth company. Had we performed a formal assessment of its internal control over financial reporting or had our independent registered public accounting firm performed an audit of the effectiveness of its internal control over financial reporting, additional material weaknesses may have been identified.

We plan to begin the process of remediating such material weaknesses but there can be no assurance as to when or if we will fully remediate such material weaknesses.

Our independent registered public accounting firm’s report contains an explanatory paragraph that expresses substantial doubt about our ability to continue as a “going concern.”

Our audited financial statements for the year ended December 31, 2025 include an explanatory paragraph from our independent registered public accounting firm expressing substantial doubt about our ability to continue as a going concern. As of December 31, 2025, we had cash of approximately $0.2 million and a working capital deficit of approximately $2.1 million. Further, we have incurred and expect to continue to incur significant costs in pursuit of our financing and the pursuit of our business objectives.

Management’s plan to address this uncertainty includes raising additional capital beyond the proceeds from this offering, which is discussed in the section of this prospectus titled “Management’s Discussion and Analysis of Financial Condition and Results of Operations.” However, we cannot assure you that we will be successful in obtaining such financing on favorable terms, or at all. If we are unable to raise additional capital as and when needed, we may be forced to delay or reduce our business activities, scale back or eliminate planned initiatives, or, in a worst-case scenario, cease operations entirely.

These factors, among others, raise substantial doubt about our ability to continue as a going concern. The financial statements contained elsewhere in this prospectus do not include any adjustments that might result from our inability to consummate this offering or our inability to continue as a going concern.

Risks Relating to Our Dependence on Third Parties

We have relied upon and plan to continue to rely upon third parties, including independent clinical investigators and third-party CROs, to conduct certain aspects of our preclinical studies and clinical trials. While we control only certain aspects of their activities, we remain responsible for ensuring trials comply with protocols, legal and regulatory standards, and our reliance on these third parties does not relieve us of our regulatory responsibilities. All parties must adhere to Good Clinical Practice (GCP) guidelines enforced by the FDA and foreign regulatory authorities through periodic inspections of trial sponsors, principal investigators, and trial sites. If we or any of these third parties fail to comply with applicable GCPs, the clinical data generated in our clinical trials may be deemed unreliable, and additional clinical trials before approving our marketing applications may be required. Our failure to comply with these regulations may require us to repeat clinical trials, which would delay the regulatory approval process. Our business may be adversely affected if any of these third parties violate federal or state fraud and abuse or false claims laws and regulations, or healthcare privacy and security laws. For the risk to manufacturing, see the section on Risks Related to Manufacturing.

Further, there is no guarantee that any such CROs, investigators, or other third parties on which we rely will devote adequate time and resources to our development activities or perform as contractually required. If these parties fail to meet obligations, adhere to protocols, or produce reliable data, our clinical trials may be extended, delayed, or terminated, and we may not be able to obtain regulatory approval for or successfully commercialize our product candidates. Consequently, our results of operations and the commercial prospects for our product candidates would be harmed, our costs could increase, and our ability to generate revenues could be delayed or halted entirely.

Our CROs have the right to terminate their agreements with us in the event of an uncured material breach. In addition, some of our CROs have the ability to terminate their respective agreements with us if it can be reasonably demonstrated that the safety of the subjects participating in our clinical trials warrants such termination, if we make a general assignment for the benefit of our creditors, or if we are liquidated. If any of our relationships with these third-party CROs terminate, finding a replacement on reasonable terms may be difficult and time-consuming. Transitioning to a new CRO can cause delays, increase costs, and divert management focus. Capacity limitations among CROs may also hinder timely support. Despite our efforts to manage these relationships, future disruptions could materially impact our development timelines, business, financial condition, and prospects.

Developing and potentially commercializing our product candidates will require significant additional funding. To support these efforts, we may pursue selective collaborations to enhance our capabilities, potentially accelerate research and development activities, and enable commercialization activities by third parties. Such collaborations could involve upfront costs, increased expenditures, equity dilution, or operational disruption.

We face significant competition in identifying and securing suitable collaborators, and the negotiation process can be complex and time-consuming. Whether we reach a definitive collaboration agreement will depend on several factors, including the collaborator’s resources, expertise, and assessment of our product candidates’ clinical data, regulatory prospects, market potential, manufacturing challenges, competing therapies, and intellectual property. Potential collaborators may choose alternative opportunities they view as more promising or may consider our programs too early-stage. In addition, mergers among large biopharmaceutical companies may result in a reduced number of potential future collaborators. Even if we are successful in entering into a collaboration, the terms and conditions of that collaboration may restrict us from entering into future agreements on certain terms with potential collaborators. Even if we enter a collaboration, we may not be able to negotiate collaborations on a timely basis, on acceptable terms, or at all. If we are unable to secure collaborations on acceptable terms, we may need to delay or scale back development or commercialization efforts, or assume full responsibility for these activities, which would increase our costs and could require additional funding. If we do not have sufficient funds, we may not be able to further develop our product candidates or bring them to market and generate product revenue.

Misconduct or Regulatory Noncompliance by Employees or Third Parties Could Adversely Affect Our Business.

We are exposed to the risk that our employees, independent contractors, consultants, commercial collaborators, principal investigators, CROs, suppliers, and vendors may engage in misconduct or other improper activities. This may include noncompliance with FDA regulations or other regulatory requirements. In particular, sales, marketing, and business arrangements in the health care industry are subject to extensive laws and regulations intended to prevent fraud, misconduct, kickbacks, self-dealing, and other abusive practices. These laws and regulations may restrict or prohibit a wide range of pricing, discounting, marketing, promotion, sales commission, customer incentive programs, and other business arrangements. Misconduct by these parties could also involve the improper use of information obtained in the course of clinical trials, which could result in regulatory sanctions and serious harm to our reputation. It is not always possible to identify and deter misconduct by these parties, and the precautions we take to detect and prevent this activity may not be effective in controlling unknown or unmanaged risks. If any actions are taken against us and we cannot successfully defend ourselves, it could significantly impact our business, resulting in penalties (civil, criminal, or administrative), fines, reputational harm, exclusion from government healthcare programs, and potential damage to profits, future earnings, or operations.

Risks Related to Manufacturing

Complexities in manufacturing and supply of our anti-infective products could delay clinical trials or commercial availability.

The manufacture of anti-infective, antimicrobial products is complex and requires significant expertise and capital investment, including advanced techniques and process controls. Manufacturers of pharmaceutical products often encounter difficulties in production and sourcing, particularly in scaling up, validating the production process, and assuring high reliability of the manufacturing processes (including the absence of contamination), in light of variations and supply constraints of critical components. These problems include logistics and shipping, difficulties with production costs and yields, quality control, including consistency, stability, purity, and efficacy of the product, product testing, operator error, and availability of qualified personnel, as well as compliance with strictly enforced federal, state, and foreign regulations. Furthermore, if contaminants are discovered, such manufacturing facilities may need to be closed for an extended period of time to investigate and remedy the contamination. We cannot assure you that any stability, purity, and efficacy failures, deficiencies, or other issues relating to manufacturing our product candidates will not occur in the future. Additionally, we may fail to manage the logistics of shipping the product candidate to the relevant parties. Logistical and shipment delays and problems caused by us, our vendors, or other factors not in our control, including business interruptions, global supply chain issues, and weather, could prevent or delay the delivery of product candidates to patients.

Changes in product candidate manufacturing or formulation methods may lead to increased costs or delays.

As product candidates proceed through development towards potential commercialization, it is common that various aspects of the development program, such as manufacturing methods, formulation, materials, and processes, are altered along the way in an effort to optimize processes and product characteristics. Such alterations can also occur due to changes in manufacturers. These changes carry the risk that they will not achieve their intended objectives. Any such changes could cause our product candidates to perform differently and affect the results of planned clinical trials or other future clinical trials conducted with product candidates produced using the modified manufacturing methods, materials, and processes. Such changes may also require additional testing, FDA notification, or FDA approval. This could delay the completion of clinical trials, require the conduct of bridging clinical trials, or the repetition of one or more clinical trials beyond those we currently anticipate, increase clinical trial costs, delay approval of our product candidates, and jeopardize our ability to commercialize our product candidates if approved. In addition, we may be required to make significant changes to our upstream and downstream processes across our pipeline, which could delay the development of future product candidates.

If we or our third-party manufacturers use hazardous and biological materials in a manner that causes injury or violates applicable law, we may be liable for damages.

Our research and development activities involve the controlled use of potentially hazardous substances, including chemical and biological materials, by us and our third-party manufacturers. Although we outsource all manufacturing to third parties, we and our manufacturers must comply with federal, state, and local regulations governing the handling, storage, and disposal of these materials. Despite adherence to legal standards, we cannot eliminate the risk of contamination or injury resulting from medical or hazardous materials. As a result of any such contamination or injury, we may incur liability, or local, city, state, or federal authorities may curtail the use of these materials and interrupt our business operations. In the event of an accident, we could be held liable for damages or penalized with fines, and the liability could exceed our resources. We do not currently have any insurance for liabilities arising from medical or hazardous materials, and compliance with applicable environmental laws and regulations is expensive. Current and future regulations could further impair our research, development, and production efforts, negatively affecting our business.

We rely on third parties for manufacturing and may continue to depend on them for future product candidates, and this increases the risk related to the timely and sufficient production of our product candidates.

We depend on third-party manufacturers for compliance with cGMP regulations in producing our product candidates. If these third-party manufacturers fail to comply with the FDA, EMA, or other regulatory standards, they will not be able to secure and/or maintain marketing approval for their manufacturing facilities. We do not have control over the ability of our contract manufacturers to maintain adequate quality control, quality assurance, and qualified personnel. Failure to comply with regulations by us or our third-party manufacturers could result in sanctions being imposed on us, including fines, injunctions, civil penalties, delays, suspension, or withdrawal of approvals, license revocation, seizures or recalls of product candidates, operating restrictions and criminal prosecutions, any of which could adversely affect supplies of our product candidates and harm our business and results of operations. Furthermore, the raw materials for our product candidates may be sourced, in some cases, from a single-source supplier. If we were to experience an unexpected loss of supply of any of our current and future product candidates for any reason, we could experience delays, disruptions, suspensions, or terminations of, or be required to restart or repeat, any pending or ongoing clinical trials.

We rely on third-party manufacturers for the production of our product candidates under the guidance of members of our organization. If these manufacturers fail to meet quality, timing, or other requirements, or if there are supply disruptions, we may be forced to enter into an agreement with another third party, which we may not be able to do on commercially reasonable terms, if at all. Any replacement of our third-party manufacturers could require significant effort and expertise because there may be a limited number of qualified replacements. In some cases, the technical skills or technology required to manufacture our product candidates may be unique or proprietary to us or the third-party manufacturer. We may have difficulty transferring such skills or technology to another third party, and a feasible alternative may not exist. Any need to switch manufacturers would require significant effort, and ensuring the new manufacturer meets the required standards may lead to delays in product development. Failure to meet manufacturing requirements or comply with cGMP regulations could adversely affect our business in a number of ways, including:

●

Inability to meet our product specifications and quality requirements consistently;

●

Inability to initiate or continue clinical trials of our product candidates under development;

●

Delays in submitting regulatory applications or receiving marketing approvals for our product candidates;

●

Inability to commercialize any product candidates that receive marketing approval on a timely basis;

●

Loss of the cooperation of future collaborators;

●

Increased inspections by regulatory authorities;

●

Potential recalls or ceasing development; and

●

Inability to meet market demand, if approved.

Risks Related to Legal and Regulatory Compliance Matters

Healthcare providers and third-party payors play a key role in recommending and prescribing our product candidates. Our arrangements with healthcare professionals, investigators, CROs, payors, and customers may be subject to healthcare laws and regulations, which could limit our marketing, sales, and distribution efforts. Restrictions under applicable federal and state healthcare laws and regulations include the following:

●

The federal Anti-Kickback Statute, which prohibits, among other things, offering or receiving remuneration to induce the purchase of goods or services paid for by federal healthcare programs, with penalties including fines, imprisonment, and exclusion from such programs;

●

The federal civil and criminal false claims laws and civil monetary penalty laws, such as the federal False Claims Act, which penalizes submitting false or fraudulent claims to the government, with whistleblower actions allowed for civil recovery;

●

The Health Insurance Portability and Accountability Act of 1996, or HIPAA, which prohibits, among other things, schemes to defraud healthcare programs and mandates strict privacy and security standards for health information, with penalties for violations;

●

HIPAA, as further amended by the Health Information Technology for Economic and Clinical Health Act of 2009, or HITECH, and their respective implementing regulations, which impose new penalties and extend liability to business associates handling health data;

●

Federal government price reporting laws, which require manufacturers to calculate and report complex pricing metrics in an accurate and timely manner to government programs;

●

Federal consumer protection and unfair competition laws, which broadly regulate marketplace activities and activities that potentially harm consumers;

●

The Affordable Care Act, or ACA, which requires reporting of payments and transfers of value to healthcare providers and disclosing ownership interests of physicians and family members; and

●

State privacy laws that govern the privacy of personal information in specified circumstances, such as the California Consumer Privacy Act or the CCPA, which establishes new data privacy rights and penalties for violations related to personal information.

Additionally, we are subject to state and foreign equivalents of each of the healthcare laws and regulations described above, among others, some of which may be broader than federal regulations. Many U.S. states have adopted laws similar to the federal Anti-Kickback Statute and False Claims Act, and may apply to our business practices, including, but not limited to, research, distribution, sales, or marketing arrangements and claims involving healthcare items or services reimbursed by non-governmental payors, including private insurers. Some states have passed laws that require biopharmaceutical companies to comply with the April 2003 Office of Inspector General Compliance Program Guidance for Pharmaceutical Manufacturers and/or the Pharmaceutical Research and Manufacturers of America’s Code on Interactions with Healthcare Professionals. Several states also impose other marketing restrictions or require biopharmaceutical companies to make marketing or price disclosures to the state and require the registration of biopharmaceutical sales representatives. Privacy and data protection laws from outside of the United States, including, for example, the European Union General Data Protection Regulation and the UK Data Protection Act 2018, or, collectively, the GDPR, also govern the privacy and security of personal information, including health information in some circumstances, and many of these laws differ from each other in significant ways, thus complicating compliance efforts. In addition, in the United States, there are a number of states that have enacted laws that govern the privacy and security of personal information, many of which differ from each other in significant ways and often are not preempted by HIPAA, thus complicating compliance efforts.

The scope and enforcement of each of these laws is uncertain and subject to rapid change, especially in light of the lack of applicable precedent and regulations. Federal and state enforcement bodies have recently increased their scrutiny of interactions between healthcare companies and healthcare providers, which has led to a number of investigations, prosecutions, convictions, and settlements in the healthcare industry. Ensuring business arrangements comply with applicable healthcare and privacy laws can be time and resource-consuming and can divert a company’s attention from the business. Ensuring that our internal operations and future business arrangements with third parties comply with applicable healthcare laws and regulations will involve substantial costs. Authorities may determine that our practices violate current or future statutes, regulations, or guidance, which could result in administrative, civil, or criminal penalties, including fines, damages, exclusion from federal and state healthcare programs, reputational harm, individual imprisonment, or forced restructuring of our operations. We could also face heightened oversight and reporting obligations under a corporate integrity agreement. Defending against enforcement actions can be costly and time-consuming, even if successful, and may impair our operations. Additionally, if our partners, such as physicians or other providers, are found non-compliant, they may face sanctions, including program exclusion and imprisonment, which could negatively impact our business and financial results.

Our business involves significant product liability risks related to the development, testing, manufacturing, and marketing of therapeutic treatments. Product liability claims could delay or halt our development programs and, if we commercialize products, may trigger investigations by the FDA, EMA, or other regulatory bodies into product safety, manufacturing processes, or marketing practices. These investigations could lead to recalls, enforcement actions, or even suspension or withdrawal of approvals. Regardless of the merits or eventual outcome, liability claims can damage our reputation, reduce demand, divert management attention, incur high legal costs, and result in substantial financial liability. We currently do not have product liability insurance, but we may need to obtain product liability insurance prior to marketing any of our product candidates, if approved. Any insurance we have or may obtain may not provide sufficient coverage against potential liabilities. Furthermore, clinical trials and product liability insurance are becoming increasingly expensive. As a result, we may be unable to obtain sufficient insurance at a reasonable cost to protect us against losses caused by product liability claims that could have an adverse effect on our business.

Any product candidates we develop may become subject to unfavorable third-party coverage and reimbursement practices, as well as pricing regulations.

The availability and extent of coverage and adequate reimbursement by third-party payors, including government health administration authorities, private health coverage insurers, managed care organizations, and other third-party payors, is essential for most patients to be able to afford expensive treatments. Our ability to successfully commercialize any product candidates that receive marketing approval, both in the United States and internationally, will largely depend on whether these payors cover and adequately reimburse the cost of our therapies. If reimbursement is unavailable or insufficient, we may not be able to commercialize our products or achieve a return on investment. Even if coverage is provided, the approved reimbursement amount may not be high enough to allow us to establish or maintain pricing sufficient to realize an adequate return on our investment. Coverage and reimbursement may impact the demand for, or the price of, any product candidate for which we obtain marketing approval. If coverage and reimbursement are not available or reimbursement is available only to limited levels, we may not successfully commercialize any product candidate for which we obtain marketing approval. For products administered under the supervision of a physician, obtaining coverage and adequate reimbursement may be particularly difficult because of the higher prices often associated with such drugs.

There is significant uncertainty related to third-party payor coverage and reimbursement of newly approved products. In the United States, no uniform policy of coverage and reimbursement for products exists among third-party payors, and coverage and reimbursement levels for products can differ significantly from payor to payor. Although the Medicare and Medicaid programs are increasingly used as models for how private payors and other governmental payors develop their coverage and reimbursement policies for drugs and biologics, one third-party payor’s determination to provide coverage for a product candidate does not assure that other payors will also provide coverage for the product candidate. As a result, the coverage determination process is often time-consuming and costly, which will require us to provide scientific and clinical support for the use of our product candidates to each third-party payor separately, with no assurance that coverage and adequate reimbursement will be applied consistently or obtained in the first instance. Factors payors consider in determining reimbursement are based on whether the product is: (i) a covered benefit under its health plan; (ii) safe, effective, and medically necessary; (iii) appropriate for the specific patient; (iv) cost-effective; and (v) neither experimental nor investigational. In addition, third-party payors are increasingly demanding predetermined discounts and scrutinizing drug prices, medical necessity, and cost-effectiveness. This may lead to delays in coverage and reimbursement for newly approved drugs. Coverage may be restricted to specific products on formularies, which might exclude some FDA-approved drugs. We may need to conduct expensive pharmacoeconomic studies to justify the value of our product candidates, but there is no guarantee they will be deemed medically necessary or cost-effective. Even if reimbursement is available, the level may be insufficient for a viable return on investment.

Our international operations are subject to extensive governmental price controls and other market regulations. We believe the increasing emphasis on cost containment initiatives in many countries has and will continue to put pressure on the pricing and usage of therapeutics such as our product candidates. Many countries, particularly in the European Union, subject medical product prices to varying price control mechanisms as part of their national health systems, often requiring lengthy pricing negotiations. To obtain reimbursement or pricing approval in some countries, we may be required to conduct a clinical trial that compares the cost-effectiveness of our product candidate to other available therapies. Additional foreign price controls or other changes in pricing regulation could restrict the amount that we are able to charge for our product candidates. Accordingly, in markets outside the United States, the reimbursement for our product candidates may be reduced compared with the United States and may be insufficient to generate commercially reasonable revenue and profits.

If we cannot secure or maintain adequate reimbursement from third-party payors, the adoption of those product candidates and sales revenue will be adversely affected, which could adversely affect the ability to market or sell those product candidates, if approved. Moreover, reimbursement policies may change at any time, and favorable coverage obtained today may not persist in the future.

We face potential liability related to the privacy of health information obtained from our sponsored clinical trials.

Most healthcare providers, including research institutions from which we obtain patient health information, are subject to HIPAA privacy and security regulations. While we are not currently classified as a covered entity or business associate under HIPAA, we could face significant criminal penalties if we knowingly receive health information from a HIPAA-covered entity that has not complied with its disclosure requirements. In addition, we may handle sensitive personal and health information throughout clinical trials, research collaborations, and patient assistance programs, making us subject to state laws requiring breach notifications to affected individuals and regulators. Certain health privacy laws, data breach notification laws, consumer protection laws, and genetic testing laws may apply directly to our operations and/or those of our collaborators, imposing restrictions on our use and dissemination of health information. Patients and providers may have rights limiting how we can use or disclose this information. We may be required to expend significant capital and other resources to ensure ongoing compliance with applicable privacy and data security laws, and even unsubstantiated claims of privacy violations or contractual breaches could be costly to defend and harm our reputation.

Failure to comply with applicable regulatory requirements by us or our third-party contractors could lead to regulatory actions that hinder our ability to develop, commercialize, or sell our product candidates, which may also increase development and marketing costs. Government enforcement actions could generate negative publicity and divert resources from other business areas. Additionally, growing social media use could lead to liability, data breaches, or reputational damage.

We are subject to numerous environmental, health, and safety laws and regulations, including those governing laboratory procedures and the handling, use, storage, treatment, and disposal of hazardous materials and wastes. While our operations do not involve the use of hazardous and flammable materials and do not produce hazardous waste products, we generally contract with third parties for all operations that handle, use, store, and dispose of these materials and wastes. We cannot eliminate the risk of contamination or injury from these materials managed by our vendors. In the event of contamination or injury resulting from their use of hazardous materials, we could be held liable for any resulting damages, and any liability could exceed our resources. We could also incur significant costs associated with civil or criminal fines and penalties. Although we maintain workers’ compensation insurance, we may incur costs due to injuries to our employees resulting from the use of hazardous materials; this insurance may not provide adequate coverage against potential liabilities. We do not maintain insurance for environmental liability or toxic tort claims that may be asserted against us in connection with our storage or disposal of hazardous and flammable materials. In addition, we may incur substantial costs to comply with current or future environmental, health, and safety laws and regulations. These current or future laws and regulations may impair our research, development, or commercialization efforts, and noncompliance may result in substantial fines, penalties, or other sanctions.

The FDA, the EMA, and other comparable foreign regulatory authorities may not accept data from trials conducted in locations outside of their jurisdiction.

If we choose to conduct international clinical trials, the FDA, the EMA, or other regulatory authorities may not accept foreign study data unless it meets certain conditions. In cases where data from foreign clinical trials are intended to serve as the basis for marketing approval in the United States, the FDA will generally not approve the application on the basis of foreign data alone unless (i) the data are applicable to the United States population and United States medical practice; (ii) the trials are performed by clinical investigators of recognized competence and pursuant to current GCP requirements; and (iii) the FDA is able to validate the data through an on-site inspection or other appropriate mean. Additionally, the trials must meet the FDA’s clinical trial requirements, including adequate patient population and statistical power. There can be no assurance that the FDA, the EMA, or any applicable foreign regulatory authority will accept data from trials conducted outside of its applicable jurisdiction. If the data is not accepted, additional trials may be required, which could cause delays, increased costs, and potentially prevent approval for commercialization.

Obtaining and maintaining regulatory approval of our product candidates in one jurisdiction does not mean that we will be successful in obtaining regulatory approval of our product candidates in other jurisdictions.

Obtaining and maintaining regulatory approval of our product candidates in one jurisdiction does not guarantee approval in any other jurisdiction. For example, even if the FDA or the EMA grants marketing approval of a product candidate, comparable regulatory authorities in foreign jurisdictions must also approve the manufacturing, marketing and promotion, and reimbursement of the product candidate in those countries. A failure or delay in obtaining regulatory approval in one jurisdiction may have a negative effect on the regulatory approval process in others. Approval procedures vary among jurisdictions and can involve requirements and administrative review periods different from those in the United States, including additional preclinical studies or clinical trials, as clinical trials conducted in one jurisdiction may not be accepted by regulatory authorities in other jurisdictions. In many jurisdictions outside the United States, a product candidate must be approved for reimbursement before it can be approved for sale in that jurisdiction. Obtaining foreign regulatory approvals and establishing and maintaining compliance with foreign regulatory requirements could result in significant delays, difficulties, and costs that may prevent or delay the introduction of our product candidates. Failure to comply with international regulatory requirements could reduce our market potential and hinder commercialization.

Even if our product candidates receive regulatory approval, they will be subject to significant post-marketing regulatory requirements and oversight. For example, the FDA may require a REMS in order to approve our product candidates, which could entail requirements for a medication guide, physician training, and communication plans or additional elements to ensure safe use, such as restricted distribution methods, patient registries, and other risk minimization tools. In addition, if the FDA, the EMA, or foreign regulatory authorities approve our product candidates, the manufacturing processes, labeling, packaging, distribution, adverse event reporting, storage, advertising, promotion, import, export, and recordkeeping for our product candidates will be subject to extensive and ongoing regulatory requirements. These requirements include submissions of safety and other post-marketing information and reports, registration, as well as ongoing compliance with cGMPs and GCP for any clinical trials that we conduct post-approval. Manufacturers of drug products and their facilities are also subject to continual review and periodic, unannounced inspections by the FDA and other regulatory authorities for compliance with cGMP regulations. If we or a regulatory agency discover previously unknown problems with a product, such as adverse events of unanticipated severity or frequency, or problems with the facilities where the product is manufactured, a regulatory agency may impose restrictions on that product, the manufacturing facility, or us, including requiring recall or withdrawal of the product from the market or suspension of manufacturing.

Failure to comply with FDA, the EMA, or other comparable foreign regulatory requirements may subject our company to administrative or judicially imposed sanctions, including delays or denials of product approvals; restrictions on clinical trials, manufacturing, or specific products; warning or untitled letters; civil or criminal penalties; injunctions; suspension or withdrawal of approvals; product seizures, import bans, recalls, or detentions; and operational restrictions, such as costly new manufacturing mandates or partial shutdowns. The occurrence of any event or penalty may inhibit our ability to commercialize our product candidates and generate revenue, and could require us to expend significant time and resources in response, and could generate negative publicity.

The FDA and other regulatory agencies enforce laws and regulations prohibiting the promotion of off-label uses.

If any of our product candidates are approved and we are found to have improperly promoted them for off-label uses, we may become subject to significant liability. Regulatory agencies like the FDA strictly limit promotional claims to those consistent with a product’s approved labeling. A product may not be promoted for uses that are not approved by the FDA, the EMA, or such other regulatory agencies as reflected in the product’s approved labeling. If we receive marketing approval for a product candidate, physicians may nevertheless prescribe it to their patients in a manner that is inconsistent with the approved label. If we are found to have promoted such off-label uses, we may become subject to significant liability. The U.S. government has imposed substantial fines and legal actions, including injunctions and consent decrees, on companies for allegedly promoting off-label uses. If we fail to manage compliant promotion of our products, we could face serious legal and financial consequences that may adversely impact our business.

We may face difficulties from changes to current regulations and future legislation.

Existing regulatory policies may change, and new government regulations could delay or prevent approval of our product candidates. We cannot predict the nature or impact of future legislation or administrative action in the United States or abroad. If we fail to adapt to changing requirements or maintain compliance, we may lose marketing approval and fail to achieve or sustain profitability. For example, the ACA substantially changed the way healthcare is financed by both the government and private insurers and significantly impacts the U.S. biopharmaceutical industry. Other legislative changes have been proposed and adopted in the United States since the ACA was enacted. These changes include aggregate reductions to Medicare payments and may result in additional reductions in Medicare and other healthcare funding, all of which could have a material adverse effect on customers for our product candidates, if approved, and accordingly, our financial operations.

There have also been several changes and challenges to the 340B drug pricing program, which imposes ceilings on prices that drug manufacturers can charge for medications sold to certain health care facilities. It is unclear how these developments could affect covered hospitals that might purchase our future product candidate and affect the rates we may charge such facilities for our approved product candidates in the future, if any. Moreover, there has been heightened governmental scrutiny in recent years over the manner in which drug manufacturers set prices for their marketed products, which has resulted in several U.S. Congressional inquiries and proposed and enacted federal and state legislation designed to bring more transparency to product pricing, review the relationship between pricing and manufacturer patient programs, and reform government program reimbursement methodologies for pharmaceutical products. The U.S. Congress has indicated that it will continue to seek new legislative measures to control drug costs. Further, on May 30, 2018, the Right to Try Act was signed into law. The law, among other things, provides a federal framework for certain patients to access certain investigational new product candidates that have completed a Phase 1 clinical trial and that are undergoing investigation for FDA approval. Under certain circumstances, eligible patients can seek treatment without enrolling in clinical trials and without obtaining FDA permission under the FDA expanded access program. There is no obligation for a drug manufacturer to make its products available to eligible patients as a result of the Right to Try Act.

We expect that healthcare reforms may result in stricter coverage criteria and downward pricing pressure, particularly from government programs like Medicare, which may influence private payors as well. Cost containment efforts may hinder our ability to generate revenue, achieve profitability, or successfully commercialize our products. Further, proposals to expand post-approval requirements or restrict promotional activities could delay marketing approvals or impose new obligations. Increased congressional scrutiny of FDA processes may also result in more stringent approval standards, labeling, and post-marketing requirements.

Risks Related to Our Intellectual Property

Our success depends on our ability to protect our intellectual property and our proprietary technologies.

Our commercial success depends in part on our ability to obtain and maintain patent protection and trade secret protection for our product candidates, proprietary technologies, and their uses, and to operate without infringing the proprietary rights of others. If we are unable to adequately protect our intellectual property rights, our competitive position could be adversely affected. We generally seek to protect our proprietary position by filing patent applications related to our product candidates in the United States and abroad. However, these applications cannot be enforced unless and until patents are issued, and only to the extent that the issued claims cover the technology. There is no assurance that our applications will result in issued patents, that any patents obtained will provide sufficient protection, or that they will not be challenged, circumvented, or found invalid or unenforceable. Even issued patents may later be found invalid or may be modified or revoked in proceedings before various patent offices or in courts. As such, the scope and effectiveness of future protection for our intellectual property remain uncertain and may not be adequate to secure or maintain a competitive advantage. These uncertainties and/or limitations in our ability to properly protect the intellectual property rights relating to our product candidates could have a material adverse effect on our financial condition and results of operations.

The patent application process involves numerous risks and uncertainties, and there is no assurance that we will successfully obtain or defend patents to protect our product candidates, which include the following:

●

Compliance requirements from the USPTO and foreign patent offices; failure to meet procedural, documentary, or fee-related obligations can result in abandonment or loss of rights;

●

Patent applications may not lead to issued patents;

●

Issued patents may be challenged, invalidated, revoked, circumvented, or found unenforceable, and may not provide a competitive advantage;

●

Uncertainty about the scope and strength of any issued patents, including whether third parties can circumvent or invalidate them;

●

Potential for others to file or obtain patents on similar technologies;

●

Risk that our patents may not cover our product candidates or their uses in the U.S. or abroad;

●

Competitors with greater resources may already hold or seek patents that block or interfere with our development and commercialization efforts;

●

Public policy pressures may lead to reduced patent protection for successful treatments, especially in the context of global health concerns; and

●

Foreign patent laws may be less favorable than U.S. laws, giving competitors in other countries a greater ability to develop and market similar products.

The patent prosecution process is costly and time-consuming, and we may not be able to pursue all desirable patent applications in a timely or cost-effective manner, or in all jurisdictions where protection could be commercially beneficial. Additionally, we may fail to identify patentable aspects of our research and development efforts before it becomes too late to secure protection. As a result, our patents and applications may not be prosecuted or enforced in a way that best serves our business interests. In addition, although we enter into non-disclosure and confidentiality agreements with employees, collaborators, CROs, manufacturers, consultants, advisors, licensors, and other third parties who have access to patentable aspects of our research and development output, any of these parties may breach such agreements and disclose information before a patent application is filed, thereby jeopardizing our ability to seek patent protection.

Composition of matter patents for pharmaceutical products, such as small molecule product candidates, often offer strong intellectual property protection regardless of their use. However, we cannot guarantee that the USPTO or foreign patent offices will find the claims in our pending composition of matter applications patentable, or that issued claims will be deemed valid and enforceable by courts. Product formulation patents for pharmaceutical products, such as small molecule product candidates, often offer strong intellectual property protection regardless of their use.

However, we cannot guarantee that the USPTO or foreign patent offices will find the claims in our pending product formulation applications patentable, or that issued claims will be deemed valid and enforceable by courts. Method of use patents, while useful for protecting specific therapeutic uses, do not prevent competitors from producing identical products for non-patented indications. Furthermore, even if competitors do not actively promote their product for our targeted indications, physicians may prescribe these products “off-label” for our targeted indications. Although off-label prescriptions may infringe our method of use patents, enforcement is difficult as off-label prescribing is both common and challenging to police. The patent landscape for biopharmaceutical companies is highly uncertain and complex, involving intricate legal and factual issues, and has been subject to extensive litigation. As a result, the existence, scope, validity, enforceability, and commercial value of our patent rights are inherently uncertain. Our current and future patent applications may not result in issued patents that adequately protect our product candidates or prevent competitors from commercializing similar products.

Furthermore, the scope of claims in a patent application can be significantly narrowed during prosecution or reinterpreted post-issuance. Even issued patents may not offer meaningful protection or prevent competitors or other third parties from entering the market. Any patents that we file may be challenged or circumvented by third parties or may be narrowed or invalidated because of challenges by third parties. Consequently, we cannot guarantee our product candidates will be protected by valid, enforceable patents. Our competitors or other third parties may develop similar or alternative technologies in a non-infringing way, which could materially impact our business, financial condition, results of operations, and prospects.

The issuance of a patent is not conclusive as to its inventorship, scope, validity, or enforceability. Our patents may not cover our product candidates and may be challenged in courts or patent offices in the United States and abroad. We may be subject to a third-party pre-issuance submission of prior art to the USPTO, or become involved in opposition, derivation, revocation, reexamination, post-grant review, or PGR, and inter partes review, or IPR, or other similar proceedings in the USPTO or foreign patent offices challenging our patent rights. The outcome of such proceedings is unpredictable and may narrow, invalidate, or render our claims unenforceable, potentially enabling third parties to commercialize competing products without compensation to us. We cannot ensure all relevant prior art has been identified or correctly assessed, and unknown unknown or underestimated prior art could negatively affect our patents’ validity or enforceability. Adverse outcomes in these proceedings could reduce the scope of, or invalidate or render unenforceable, our patent rights, allow third parties to commercialize our product candidates and compete directly with us, without payment to us. Such loss of patent rights, loss of exclusivity, or in patent claims being narrowed, invalidated, or held unenforceable could limit our ability to stop others from using or commercializing similar or identical technology and products, or limit the duration of the patent protection of our product candidates. These proceedings may also be costly and time-consuming, diverting key resources even if resolved in our favor. Additionally, any perceived weakening of our patent portfolio could deter potential collaborators or licensors from partnering with us on the development or commercialization of our product candidates.

Specifically, obtaining and enforcing patents in the biopharmaceutical industry involves a high degree of technological and legal complexity. Therefore, obtaining and enforcing biopharmaceutical patents is costly, time-consuming, and inherently uncertain. Changes in the patent laws or in the interpretations of patent laws in the United States and other countries may diminish our ability to protect our inventions, obtain, maintain, and enforce our intellectual property rights, which could affect the value of our intellectual property and may increase the uncertainties and costs surrounding the prosecution of patent applications and the enforcement or defense of issued patents. We cannot predict the scope of claims that will be allowed in our patents or third-party patents. Congress or other foreign legislative bodies may pass patent reform legislation that is unfavorable to us or narrows the scope of our owned and licensed patents. Recent U.S. Supreme Court rulings have limited patent protection in some cases, creating uncertainty regarding the value of existing patents. Unpredictable changes in patent laws, regulations, or decisions by the U.S. Congress, federal courts, or the USPTO could further weaken our ability to obtain and enforce patents.

We may not identify relevant third-party patents or may misinterpret their relevance, scope, or expiration, which might adversely affect our ability to develop and market our product candidates.

We cannot guarantee that any of our patent searches or analyses, including identifying relevant patents, interpreting the scope of patent claims, or determining the expiration of relevant patents, are complete or thorough. It is possible that we have not identified all third-party patents or pending applications that may be relevant or necessary for the commercialization of our product candidates. The scope of a patent claim depends on legal interpretation, the written disclosure in a patent, and its prosecution history. Our interpretation of the scope or relevance of existing or pending patents may be incorrect, potentially impairing our ability to develop or commercialize our products. We may mistakenly conclude that our product candidates do not infringe a third-party patent or fail to anticipate that a pending application will issue with claims of relevant scope. Additionally, we may miscalculate the expiration of a relevant patent, which could also adversely affect our commercialization plans. Our failure to identify and correctly interpret relevant patents may negatively impact our ability to develop and market our product candidates.

The patentability of our inventions partly depends on the scope and content of the “prior art,” or information available to a person of skill in the relevant art prior to the priority date of the claimed invention. There may be prior art of which we are not aware that could impact the patentability of our patent claims or, if issued, affect the validity or enforceability of a patent claim. Additionally, we may not fully understand or identify all third-party intellectual property rights relevant to our product candidates or their uses. Additionally, we may not fully understand or identify all third-party intellectual property rights relevant to our product candidates or their uses. Since patent applications in the United States and many other countries are confidential for typically a period of 18 months after filing, or may not be published at all; we cannot be certain that we were the first to file a patent application for our product candidates. As a result, the issuance, scope, validity, enforceability, and commercial value of our patent rights are highly uncertain.

Our patents or pending applications may also be challenged in courts or patent offices in the United States and abroad. For example, we could face third-party pre-issuance submission of prior art to the USPTO or become involved in PGR procedures, oppositions, derivations, reexaminations, or IPR proceedings, challenging our patent rights or the patent rights of others. An adverse determination in any such challenges may result in loss of exclusivity or in patent claims being narrowed, invalidated, or held unenforceable, in whole or in part, which could limit our ability to stop others from using or commercializing similar or identical technology and products or limit the duration of the patent protection of our technology and products. Given the amount of time required for the development, testing, and regulatory review of new product candidates, patents covering our product candidates may expire before or soon after commercialization. Any failure to obtain or maintain robust patent protection could materially and adversely affect our business, financial condition, results of operations, and prospects.

Some of our future intellectual property may result from government-funded programs and therefore, be subject to federal regulations, including reporting requirements and U.S. manufacturing preferences. These obligations could limit our exclusive rights and restrict our ability to engage non-U.S. manufacturers.

Some of the intellectual property rights we may acquire or license in the future may be generated through the use of U.S. government funding and thus be subject to federal regulations. These regulations grant the government certain rights, including a non-exclusive, non-transferable, irrevocable worldwide license to use inventions for any governmental purpose. Under certain limited circumstances, the government may require us to grant exclusive, partially exclusive, or non-exclusive licenses to third parties for these inventions if it determines that: (i) adequate steps have not been taken to commercialize the invention; (ii) government action is needed to address public health or safety needs; or (iii) action is necessary to meet public use requirements under federal regulations (commonly referred to as “march-in rights”). The government may also claim ownership if an invention is not properly disclosed or if patent applications are not timely filed. Additionally, inventions developed under government funding are subject to certain reporting requirements, compliance with which may require us to expend substantial resources. The government generally requires that all products embodying these inventions, or produced through the use of any of these inventions, be manufactured substantially in the United States. While this requirement may be waived if the owner or assignee of the intellectual property can show that reasonable but unsuccessful efforts have been made to grant licenses on similar terms to potential licensees that would be likely to manufacture substantially in the United States or that under the circumstances domestic manufacture is not commercially feasible, this preference may limit our ability to contract with non-U.S. product manufacturers. To the extent any of our future intellectual property is also generated through the use of U.S. government funding, the provisions of the Bayh-Dole Act may similarly apply.

Derivation or interference proceedings, whether initiated by us or third parties, may be necessary to resolve patent priority or inventorship issues. An unfavorable outcome could result in the loss of patent rights or force us to cease using the related technology or license it from the prevailing party. If a license is not offered on commercially reasonable terms, or if we are unsuccessful in defending such proceedings, it could lead to significant costs, management distraction, and harm to our ability to secure funding, continue clinical trials, or form necessary partnerships for our product candidates. Derivation or interference proceedings provoked by third parties or brought by us or declared by the USPTO or similar proceedings in foreign patent offices may be necessary to determine the priority of inventions with respect to, or correct the inventorship of, our patents or patent applications. In addition, any such intellectual property litigation, including derivation or interference proceedings, may lead to public announcements, rulings, and other interim proceedings that could negatively affect investor perception and the value of our product candidates. Such announcements could also harm our reputation or the market for our future product candidates, which could have a material adverse effect on our business.

Patent terms may not provide sufficient protection for our competitive position on product candidates, and if we do not obtain patent term extension for our product candidates, our business may be materially harmed.

Patents have a limited lifespan, typically 20 years from the first effective filing date in the United States, subject to timely maintenance fees. Although extensions may be available, the term of a patent and the protection it affords are limited. Patents for our product candidates may expire before or shortly after commercialization, so our patent portfolio may not provide us with sufficient rights to exclude others from commercializing products similar or identical to ours. Additionally, while a patent’s lifespan can be extended due to delays caused by the USPTO, any delays caused by the patent applicant during prosecution may reduce or eliminate this extension.

Depending on the timing and specifics of FDA marketing approval, one or more of our U.S. patents may be eligible for limited patent term restoration under the Drug Price Competition and Patent Term Restoration Act of 1984, or the Hatch-Waxman Amendments, which can extend patent life by up to five years. However, a maximum of only one patent may be extended per FDA-approved product. The extension cannot exceed 14 years from the date of product approval, and only those claims covering such approved drug product, a method for using it, or a method for manufacturing it may be extended. Patent term extensions may also be available in certain foreign countries. We may not be granted an extension if we fail to meet deadlines or other requirements, and the extension term could be shorter than requested. If we cannot obtain a patent term extension or if the extension is shorter than requested, our competitors may launch similar products after our patent expires and leverage our data to launch their products earlier. If we do not have sufficient patent life to protect our products, our business and results of operations will be adversely affected.

We may not be able to protect our intellectual property rights throughout the world.

Filing, prosecuting, and defending patents globally would be prohibitively expensive, and our intellectual property rights in some countries may be less extensive than those in the United States, particularly in developing countries with less robust protections. Consequently, we may struggle to prevent third parties from using our inventions in regions where we lack patent protection or where enforcement is weaker, potentially allowing competitors to develop similar products and export them into patent-protected areas, undermining our competitive position.

Protecting and enforcing our intellectual property in foreign jurisdictions can be difficult and costly, as many foreign legal systems do not favor the enforcement of patents, trade secrets, and other intellectual property protection. Enforcing our rights abroad could result in significant costs, potential invalidation of our patents, and even provoke third-party claims. We may not succeed in legal actions we initiate, and any damages awarded may not be commercially meaningful. Additionally, if our trade secrets are disclosed internationally, competitors worldwide could have access to our proprietary information, and such disclosure could have a material adverse effect on our business. Accordingly, our efforts to enforce our intellectual property rights around the world may be inadequate to obtain a significant commercial advantage from the intellectual property that we develop or license. Certain countries, like China and India, have compulsory licensing laws under which a patent owner may be compelled to grant licenses to third parties. In those countries, we may have limited remedies if patents are infringed or if we are compelled to grant a license to a third party, which could materially diminish the value of those patents. In addition, many countries limit the enforceability of patents against government agencies or government contractors, which could materially diminish the value of such a patent. If we are forced to grant a license to third parties with respect to any patents relevant to our business, our competitive position may be impaired, and our business may be adversely affected.

Because of the expense and uncertainty of litigation in certain foreign jurisdictions, we may determine that enforcing our patents or other intellectual property rights, even in cases of infringement, is not practical or in the best interest of our company or shareholders. Our competitors or other third parties may be able to sustain the costs of complex patent litigation or proceedings more effectively than we can because of their greater financial resources and more mature intellectual property portfolios. As a result, we might opt to monitor the situation or pursue non-litigious solutions instead. In addition, ongoing or potential litigation could compromise our ability to raise the funds necessary to continue our clinical trials, continue our internal research programs, in-license needed technology or other product candidates, or enter into development partnerships that would help us bring our product candidates to market.

Failure to protect our trade secrets could harm our business and competitive position.

In addition to the protection afforded by other types of intellectual property, we rely on the protection of our trade secrets, including unpatented know-how, technology, and other proprietary information, to maintain our competitive position. Although we have taken steps to protect our trade secrets and unpatented know-how, including entering into confidentiality agreements with employees, consultants, advisors, and third parties such as contractors and collaborators, we cannot guarantee that all such agreements have been duly executed, and any of these parties may not breach and disclose our proprietary information, and we may not be able to obtain adequate remedies for such breaches. We require our employees to enter into written confidentiality agreements that assign to us any inventions or developments made during their employment, and third-party contractors are also typically bound by non-disclosure agreements limiting their use and disclosure of our confidential information. Enforcing trade secret claims can be difficult, costly, time-consuming, and unpredictable, and some courts inside and outside the United States are less willing or unwilling to protect trade secrets. We may need to share our proprietary information, including trade secrets, with our current and future business partners, collaborators, and contractors located in countries where there is an elevated risk of misappropriation, including from private or state-affiliated actors.

Moreover, competitors may independently discover or otherwise gain access to our trade secrets, and we would have no right to stop them from using the information to compete with us. Loss of trade secret protection could significantly reduce the value of our proprietary information and harm our competitive position. If we fail to seek patent protection before public disclosure or cannot maintain confidentiality, our ability to secure patents or protect trade secrets may be compromised. We may also face claims that we wrongfully hired an employee from a competitor or that we or our employees have wrongfully used or disclosed alleged confidential information of their former employers.

We may be subject to claims that our employees, consultants, or independent contractors have wrongfully used or disclosed confidential information of third parties.

As is common in the biopharmaceutical industry, we engage consultants in addition to our employees to support the development of our product candidates. Many of these individuals have previously worked for, or are currently providing services to, other biopharmaceutical companies, including potential competitors. As a result, we may face claims that we, our employees, contractors, or consultants have inadvertently or improperly used or disclosed trade secrets or proprietary information of their former or current clients. Litigation may be necessary to defend against these claims. In addition to paying monetary damages, an adverse outcome could result in the loss of valuable intellectual property rights or personnel, which could adversely affect our business. Even if we prevail, litigation could result in substantial costs and be a distraction to our management team and other employees.

If our trademarks and trade names are not adequately protected, then we may not be able to build name recognition in our markets of interest, and our business may be adversely affected.

Our current or future trademarks or trade names may be challenged, infringed, circumvented, deemed descriptive or generic, or found to infringe on other marks. If we are unable to protect or continue using these trademarks and trade names, we may lose valuable brand recognition among partners and customers. Trademark applications may be rejected by the USPTO or foreign agencies, and even if accepted, they can be opposed or cancelled by third parties. Although we would be given an opportunity to respond to those rejections, we may be unable to overcome such rejections. In the USPTO and similar agencies abroad, third parties can oppose pending trademark applications or seek to cancel registered trademarks. Opposition or cancellation proceedings may be filed against our trademarks, and our trademarks may not survive such proceedings. If we are unable to establish name recognition based on our trademarks and trade names, we may not be able to compete effectively, and our business may be adversely affected. We may license our trademarks and trade names to third parties, but any misuse or breach of terms on these license agreements could weaken our rights in or diminish the goodwill associated with our trademarks and trade names.

Moreover, any name we have proposed to use with product candidates in the United States may need FDA approval, regardless of whether we have registered it or applied to register it as a trademark, and similar requirements exist in Europe. If the FDA (or an equivalent administrative body in a foreign jurisdiction) objects to any of our proposed proprietary product names, we may need to invest significant time and resources to secure an acceptable alternative that complies with trademark laws, avoids third-party conflicts, and is acceptable to the FDA. Furthermore, in many countries, owning and maintaining a trademark registration may not provide an adequate defense against a subsequent infringement claim asserted by the owner of a senior trademark. Competitors or other third parties may adopt trade names or trademarks similar to ours, thereby impeding our ability to build brand identity and possibly leading to market confusion. In addition, we could face trade name or trademark infringement claims from owners of registered or unregistered marks that are similar to ours. If we assert trademark infringement claims, a court may find our marks invalid, or that the party against whom we have asserted trademark infringement has superior rights to the marks in question. In this case, we could ultimately be forced to cease use of such trademarks.

Risks Related to This Offering and Ownership of Our Common Stock

The market price of shares of our common stock may be volatile.

The public price of our common stock following could be subject to wide fluctuations in response to the risk factors described in this prospectus and others beyond our control, including:

●

The number of shares of our common stock publicly owned and available for trading;

●

Variations in our operating performance and the performance of our competitors in general;

●

Actual or anticipated fluctuations in our quarterly or annual operating results;

●

Publication of research reports by securities analysts about us or our competitors, or our industry;

●

The public’s reaction to our press releases, our other public announcements, and our filings with the SEC;

●

Our failure or the failure of our competitors to meet analysts’ projections or guidance that we or our competitors may give to the market;

●

Additions and departures of key personnel;

●

Changes in laws and regulations affecting our business;

●

Commencement of, or involvement in, litigation involving us;

●

Changes in our capital structure, such as future issuances of securities or the incurrence of additional debt;

●

The volume of shares of our common stock available for public sale; and

●

General economic and political conditions such as recessions, interest rates, fuel prices, foreign currency fluctuations, international tariffs, social, political, and economic risks, and acts of war or terrorism.

In addition, securities exchanges have experienced price and volume fluctuations that have affected and continue to affect the market prices of equity securities of many companies. Stock prices of many companies have fluctuated in a manner often unrelated to the operating performance of those companies. In the past, stockholders have instituted securities class action litigation following periods of market volatility. If we were to become involved in securities litigation, it could subject us to substantial costs, divert resources and the attention of management from our business, and harm our business, results of operations, and financial condition.

If we fail to meet the continued listing requirements of Nasdaq, Nasdaq may delist our securities.

As a public company, we are subject to the reporting requirements and the rules and regulations of the applicable listing standards of Nasdaq. If we fail to maintain compliance with the continued listing standards of Nasdaq, our securities may be delisted, which could negatively affect the market price and liquidity of our securities. In such a case, we may seek to regain compliance by implementing a number of available options. If in the future our securities are delisted from Nasdaq, we could face significant material adverse consequences, including: limited availability of market quotations for our securities; reduced liquidity for our shares; a determination that our shares are “penny stock,” which will require brokers trading in our shares to adhere to more stringent rules and possibly result in a reduced level of trading activity in the secondary trading market for our shares; a limited amount of news and analyst coverage; and decreased ability to issue additional securities or obtain additional financing in the future. In addition, as long as our shares are listed on Nasdaq, U.S. federal law prevents or preempts the states from regulating their sale, although the law does allow the states to investigate companies if there is a suspicion of fraud, and if there is a finding of fraudulent activity, then the states can regulate or bar their sale. If we were no longer listed on Nasdaq, we would be subject to regulations in each state in which we offer our shares.

A significant number of our shares are eligible for sale, and their sale or potential sale may depress the market price of our ordinary shares.

Sales of a significant number of shares of our Common Stock in the public market could harm the market price of our Common Stock. If a significant number of shares were sold, such sales would increase the supply of our Common Stock in the public market, thereby potentially causing a decrease in its price. Some or all of our Common Stock may be offered from time to time in the open market pursuant to effective registration statements and/or compliance with Rule 144, which sales could have a depressive effect on the market for our Common Stock. The sale of a significant portion of such shares when such shares are eligible for public sale may cause the value of our Common Stock to decline in value.

Because we have no current plans to pay cash dividends on our common stock, you may not receive any return on investment unless you sell your common stock for a price greater than that which you paid for it.

We currently intend to retain all available funds and any future earnings to fund the development, commercialization, and growth of our business, and therefore, we do not anticipate declaring or paying any cash dividends on our common stock in the foreseeable future. Any future determination to declare dividends will be made at the discretion of our Board of Directors and will depend on our financial condition, operating results, capital requirements, general business conditions, and other factors that our Board of Directors may deem relevant. Our future ability to pay cash dividends on our common stock may also be limited by the terms of any future debt securities or credit facility. As a result, capital appreciation, if any, of the common stock you purchase in this offering will be your sole source of gain for the foreseeable future.

We are an emerging growth company and a smaller reporting company, and the reduced disclosure requirements applicable to emerging growth companies and smaller reporting companies may make our common stock less attractive to investors.

We are an “emerging growth company,” as defined in the JOBS Act. For as long as we continue to be an emerging growth company, we may take advantage of certain exemptions and relief from various reporting requirements that are applicable to other public companies that are not emerging growth companies, including (i) not being required to comply with the auditor attestation requirements of Section 404 of the Sarbanes-Oxley Act, (ii) having the option of delaying the adoption of certain new or revised financial accounting standards, (iii) reduced disclosure obligations regarding executive compensation in this prospectus and our periodic reports and proxy statements and (iv) exemptions from the requirements of holding a nonbinding advisory vote on executive compensation and shareholder approval of any golden parachute payments not previously approved. We may take advantage of these exemptions until such time as we are no longer an emerging growth company. Accordingly, the information contained herein may be different than the information you receive from other public companies in which you hold stock. Further, pursuant to Section 107 of the JOBS Act, we have elected to take advantage of the extended transition period for complying with new or revised accounting standards until those standards would otherwise apply to private companies. As a result, our operating results and financial statements may not be comparable to the operating results and financial statements of other companies that have adopted the new or revised accounting standards.

We are also a “smaller reporting company” as defined in the Exchange Act. We may continue to be a smaller reporting company even after we are no longer an emerging growth company. We may take advantage of certain of the scaled disclosures available to smaller reporting companies until the fiscal year following the determination that our voting and non-voting common stock held by non-affiliates is $250 million or more measured on the last business day of our second fiscal quarter, or our annual revenues are less than $100 million during the most recently completed fiscal year and our voting and non-voting common stock held by non-affiliates is $700 million or more measured on the last business day of our second fiscal quarter.

It is possible that some investors will find our common stock less attractive as a result of the foregoing, which may result in a less active trading market for our common stock and higher volatility in our stock price.

General Risks

Reports published by analysts, including projections in those reports that differ from our actual results, could adversely affect the price and trading volume of our common stock.

Securities research analysts may establish and publish their own periodic projections for our Company. These projections may vary widely and may not accurately predict the results we achieve. The price of our common stock may decline if our actual results do not match the projections of these securities research analysts. Similarly, if one or more of the analysts who write reports on us downgrade our stock or publish inaccurate or unfavorable research about our business, our stock price could decline. If one or more of these analysts ceases coverage of us or fails to publish reports on us regularly, our stock price or trading volume could decline.

Despite the implementation of security measures, our internal computer systems and those of our current and any future CROs and other contractors, consultants, collaborators, and third-party service providers are vulnerable to damage from computer viruses, cybersecurity threats, unauthorized access, natural disasters, terrorism, war, and telecommunication and electrical failure. Because the techniques used to obtain unauthorized access to, or to sabotage, systems change frequently and often are not recognized until launched against a target, we may be unable to anticipate these techniques or implement adequate preventative measures. We may also experience security breaches that may remain undetected for an extended period. If such an event were to occur and cause interruptions in our operations or result in the unauthorized acquisition of or access to personally identifiable information or individually identifiable health information (violating certain privacy laws such as HIPAA and GDPR), it could result in a material disruption of our drug discovery and development programs and our business operations, whether due to a loss of our trade secrets or other similar disruptions. Some of the federal, state, and foreign government requirements include obligations of companies to notify individuals of security breaches involving personally identifiable information, which could result from breaches experienced by us or by our vendors, contractors, or organizations with which we have formed strategic relationships. Notifications and follow-up actions related to a security breach could impact our reputation, cause us to incur significant costs, including legal expenses and remediation costs. For example, the loss of clinical trial data from completed or future clinical trials could result in delays in our regulatory approval efforts and significantly increase our costs to recover or reproduce the lost data. We also rely on third parties for certain portions of our manufacturing process, and similar events relating to their computer systems could also have a material adverse effect on our business. To the extent that any disruption or security breach were to result in a loss of, or damage to, our data, or inappropriate disclosure of confidential or proprietary information, we could be exposed to litigation and governmental investigations, the further development and commercialization of our product candidates could be delayed, and we could be subject to significant fines or penalties for any noncompliance with certain state, federal and/or international privacy and security laws. Our insurance policies may not be adequate to compensate us for the potential losses arising from any such disruption, failure, or security breach. In addition, such insurance may not be available to us in the future on economically reasonable terms, or at all. Further, our insurance may not cover all claims made against us and could have high deductibles in any event, and defending a suit, regardless of its merit, could be costly and divert management attention.

Our facility is located in a region that experiences severe weather from time to time. We have not undertaken a systematic analysis of the potential consequences to our business and financial results from a major tornado, flood, fire, earthquake, power loss, terrorist activity, or other disasters, and do not have a recovery plan for such disasters. In addition, we currently do not carry sufficient insurance to compensate us for actual losses from interruption of our business that may occur, and any losses or damages incurred by us could harm our business. The occurrence of any of these disruptions could seriously harm our operations and financial condition and increase our costs and expenses.

We could issue a significant number of shares of common stock in the future in connection with investments or acquisitions. Any of these issuances could dilute our existing stockholders, and such dilution could be significant. Moreover, such dilution could have a material adverse effect on the market price for the shares of our common stock.

The future issuance of shares of preferred stock with voting rights may adversely affect the voting power of the holders of shares of our common stock, either by diluting the voting power of our common stock if the preferred stock votes together with the common stock as a single class, or by giving the holders of any such preferred stock the right to block an action on which they have a separate class vote, even if the action were approved by the holders of our shares of our common stock.

The future issuance of shares of preferred stock with dividend or conversion rights, liquidation preferences, or other economic terms favorable to the holders of preferred stock could adversely affect the market price for our common stock by making an investment in the common stock less attractive. For example, investors in the common stock may not wish to purchase common stock at a price above the conversion price of a series of convertible preferred stock because the holders of the preferred stock would effectively be entitled to purchase common stock at the lower conversion price, causing economic dilution to the holders of common stock.

Industry and Market Data

This Prospectus contains estimates made, and other statistical data published by independent parties and by us relating to market size and growth, and other data about our industry. We obtained the industry and market data in this Prospectus from our own research as well as from industry and general publications, surveys, and studies conducted by third parties. This data involves a number of assumptions and limitations and contains projections and estimates of the future performance of the industries in which we operate that are inherently subject to a high degree of uncertainty, and actual events or circumstances may differ materially from events and circumstances reflected in this information. We caution you not to give undue weight to such projections, assumptions, and estimates. In addition, while we believe that the results and estimates from our internal research are reliable, such results and estimates have not been verified by any independent source.

USE OF PROCEEDS

The Selling Stockholders may, or may not, elect to sell their shares of our common stock covered by this prospectus. To the extent any Selling Stockholder chooses to sell their shares of our common stock covered by this prospectus, we will not receive any proceeds from any such sales of our common stock. See “Selling Stockholders” and “Plan of Distribution.”

DIVIDEND POLICY

We have never declared or paid cash dividends on our common stock. We currently intend to retain all available funds and any future earnings to fund the development, commercialization, and growth of our business, and therefore, we do not anticipate declaring or paying any cash dividends on our common stock in the foreseeable future. Any future determination as to the declaration and payment of dividends, if any, will be at the discretion of our Board of Directors. Any such determination will also depend upon our business prospects, operating results, financial condition, capital requirements, general business conditions, and other factors that our Board of Directors may deem relevant. Our future ability to pay cash dividends on our common stock may also be limited by the terms of any future debt securities or credit facility.

MANAGEMENT’S DISCUSSION AND ANALYSIS OF
FINANCIAL CONDITION AND RESULTS OF OPERATIONS

You should read the following discussion and analysis of our financial condition and results of operations together with our financial statements and related notes appearing elsewhere in this prospectus. Some of the information contained in this discussion and analysis or set forth elsewhere in this prospectus, including information with respect to our plans and strategy for our business and related financing, includes forward-looking statements that involve risks and uncertainties. As a result of many factors, including those factors set forth in the section titled “Risk factors,” our actual results could differ materially from the results described in or implied by the forward-looking statements contained in the following discussion and analysis. See also the section titled “Special note regarding forward-looking statements.” Our historical results are not necessarily indicative of the results that may be expected for any period in the future.

Overview and History

Lakewood-Amedex Biotherapeutics Inc. (the “Company,” “Lakewood-Amedex,” “we,” “us,” or “our”), a Nevada corporation headquartered in University Park, Florida, is a clinical-stage biopharmaceutical company focused on the discovery and development of novel antimicrobial therapeutics to address critical unmet medical needs in infectious diseases, particularly those driven by antimicrobial resistance (AMR).

The Company was originally incorporated in Delaware on July 11, 2006, under the name Nu Pharmas, Inc., following the acquisition of substantially all the assets of Renaissance Nutraceuticals, Inc., a Delaware corporation, on April 9, 2007. With an initial focus on antisense RNA technologies and the contract manufacturing of oligonucleotides, Nu Pharmas changed its name to Amedex Therapeutics, Inc. in 2007. On November 11, 2007, Amedex Therapeutics acquired substantially all of the assets of Lakewood Pharmaceuticals, Inc., a Delaware corporation. Subsequently, on February 1, 2008, the Company was renamed Lakewood-Amedex Inc. On June 5, 2025, the Company changed its name to Lakewood-Amedex Biotherapeutics Inc. and re-domiciled as a Nevada corporation. On September 29, 2025, the Company filed a certificate of amendment to its articles of incorporation effecting a 1-for-5.92 reverse stock split.

In 2012 and 2013, the Company transitioned its research focus from oligonucleotide therapeutics to small molecule antimicrobials, particularly a novel class of compounds known as Bisphosphocins^®, which were discovered serendipitously during early-stage antisense RNA testing. Bisphosphocins^® are synthetic antimicrobial nucleotide derivatives that exhibit broad-spectrum activity and have shown potent effects against multiple drug-resistant bacterial strains.

We are addressing the global AMR crisis, which is directly responsible for approximately 1.27 million deaths annually and contributes to nearly 5 million deaths worldwide. The rising threat of drug-resistant pathogens, including MRSA, VRE, and others, has rendered many existing antibiotics ineffective, leading to higher healthcare costs, longer hospital stays, and increased mortality. Despite the urgency of this public health challenge, innovation in antibiotic development has slowed significantly, with many recent approvals derived from existing classes that remain vulnerable to known resistance mechanisms.

Our lead product candidate, Nu-3, is a broad-spectrum Bisphosphocin^® antimicrobial formulated for the topical treatment of chronically infected diabetic foot ulcers (DFUs). We have successfully completed a first-in-human exploratory clinical trial and plan to advance Nu-3 into a Phase 2a safety and dose-response trial, followed by a placebo-controlled Phase 2b study. The Phase 2b study is designed to determine the optimal dosing regimen and support the design of pivotal Phase 3 trials for future regulatory approval and commercialization.

In addition to Nu-3, we are advancing a pipeline of early-stage Bisphosphocin^® compounds such as Nu-8, Nu-10, and Nu-11, targeting a range of acute and chronic infectious indications. These pipeline candidates will undergo further preclinical development to identify the best compound-indication match for advancement into clinical evaluation.

As of March 2026, we held 68 issued patents and had 36 pending patent applications covering our core technologies and product candidates in key global pharmaceutical markets.

Financial Overview

Since inception, we have devoted substantially all of our resources to research and development activities, including preclinical studies and clinical trials, corporate infrastructure development, intellectual property protection, and fundraising efforts. We have not generated any revenue from product sales. From inception through December 31, 2025, we have raised $46.1 million in gross proceeds through the issuance of convertible preferred stock, common stock, and convertible debt.

We have incurred significant net losses since our inception. For the years ended December 31, 2025 and 2024, we reported net losses of $3.8 million and $4.8 million, respectively. As of December 31, 2025, we had an accumulated deficit of $53.4 million. These losses have resulted primarily from expenditures related to our research and development programs and general and administrative expenses. We expect to continue to incur significant losses for the foreseeable future.

Manufacturing and Supply Chain

We do not own or operate any manufacturing facilities and have no current plans to establish internal manufacturing capabilities. We rely on third-party contract development and manufacturing organizations (CDMOs) to produce clinical supply materials and intend to continue this approach for commercial production, if applicable. These third parties are also responsible for packaging, labeling, storing, and distributing our clinical trial materials, and are expected to perform the same functions for any commercial products if and when we receive regulatory approval.

We believe this outsourced model enables us to remain capital-efficient and allows us to focus our resources on advancing our pipeline and enhancing our proprietary development platforms.

Future Operating Plans

We anticipate our operating expenses will increase substantially as we:

●

Advance our lead candidate, Nu-3, through ongoing and future clinical trials;

●

Finalize preclinical development activities for additional pipeline candidates and file Investigational New Drug (IND) applications

●

Conduct preclinical studies and clinical trials for new product candidates;

●

Expand our discovery research programs to identify novel antimicrobial candidates;

●

Seek regulatory approvals for candidates that successfully complete clinical trials;

●

Protect and enhance our intellectual property portfolio;

●

Hire additional clinical, regulatory, scientific, quality, and administrative personnel;

●

Advance our Quality Management System and 21CFR11 compliant Document Management System

●

Secure third-party manufacturing capabilities for future development and commercialization needs;

●

Establish commercial infrastructure for sales, marketing, and distribution;

●

Enhance internal systems and personnel to comply with public company reporting obligations.

Due to the inherent risks and uncertainties associated with pharmaceutical product development, we are unable to predict with certainty the timing or extent of future expenditures or whether we will ever achieve profitability.

Components of Our Results of Operations

Our results of operations have consisted primarily of operating expenses, which include the following components:

Operating Expenses

Our operating expenses are classified into two primary categories:

●

Research and development (“R&D”) expenses

●

General and administrative (“G&A”) expenses

Research and Development Expenses

R&D expenses represent costs incurred in connection with the discovery and development of our product candidates and our proprietary platform technologies. These expenses primarily include:

●

External costs, including fees paid to:

●

Contract research organizations (“CROs”),

●

Contract development and manufacturing organizations (“CDMOs”),

●

Third-party consultants,

●

Research laboratories and other service providers that support our preclinical and clinical development programs.

●

Internal costs, which consist primarily of:

●

Salaries, stock-based compensation, and other employee-related expenses for personnel involved in R&D activities,

●

Facility-related costs directly attributable to R&D operations.

We expense R&D costs as incurred. Costs for certain activities are recognized based on an evaluation of the progress to completion of specific tasks using data such as information provided to us by our vendors, and analyzing the progress of our preclinical and clinical studies or other services performed. To date, a substantial majority of our R&D spending has related to external costs incurred in connection with the development of our product candidates. While we allocate internal resources toward product innovation, early discovery, preclinical development, clinical program management, and oversight of manufacturing partners, we do not currently track R&D expenses on a program-specific basis until a product candidate is designated for development in a specific therapeutic area.

The successful development of our current or any future product candidates is highly uncertain and subject to numerous risks, many of which are beyond our control. These include clinical trial design, regulatory requirements, manufacturing constraints, and evolving government policies. Product candidates at later stages of development typically incur higher costs, primarily due to increased clinical trial size, extended duration, and enhanced regulatory and safety requirements. Accordingly, we expect our R&D expenses to increase substantially in future periods as we:

●

Advance our lead product candidate, Nu-3, through clinical development;

●

Progress additional pipeline candidates through preclinical and clinical phases;

●

Expand our and discovery research programs;

●

Prepare for potential regulatory submissions and commercialization; and

●

Advance our Quality Management System and 21CFR11 compliant Document Management System.

Because of the inherent uncertainty involved in clinical development, we cannot reasonably estimate the timing or total costs required to complete the development of our existing or future pipeline candidates. Our future R&D expenses will depend on numerous factors, including but not limited to:

●

The number, scope, progress, and results of current and future preclinical studies and clinical trials;

●

Per-patient trial costs and trial size;

●

Establishing an appropriate safety profile in both preclinical studies and clinical trials;

●

Geographic scope and the number of clinical sites participating in each study;

●

Patient enrollment rates and duration of follow-up;

●

Number of treatment arms and dosing regimens;

●

Patient discontinuation or drop-out rates;

●

Regulatory feedback or new requirements imposed during development;

●

Costs and timing of clinical supply manufacturing;

●

Changes in applicable laws, regulations, or agency guidance;

●

The potential establishment of development or commercialization partnerships;

●

Obtaining and maintaining patent and trade secret protection and regulatory exclusivity for our product candidates.

Any change in these variables could substantially impact our projected costs, timing, and likelihood of successful development.

General and Administrative Expenses

General and administrative expenses consist primarily of personnel-related expenses for employees in executive, finance, legal, human resources, and other corporate functions. These include salaries, benefits, and stock-based compensation.

G&A expenses also include:

●

Professional fees for legal, accounting, auditing, consulting, and tax services;

●

Legal expenses related to patent filings and intellectual property protection;

●

Facilities-related costs not allocated to R&D;

●

Insurance premiums, including director and officer liability insurance;

●

Travel and other administrative costs.

We expect our general and administrative expenses to increase in future periods as we:

●

Expand our corporate infrastructure to support current and anticipated R&D activities;

●

Increase headcount to support operations as a public company;

●

Incur additional audit, legal, regulatory, compliance, investor relations, and public reporting costs associated with our transition to a publicly traded company.

Other Income (Expense), Net

Interest Income

Interest income consists of income earned from our cash and cash equivalents. We expect interest income to increase in the short term due to higher cash balances resulting from the net proceeds of the Series C convertible Preferred Stock financing outlined under the Proposed Convertible Financing section.

Other Expense

Other expense consists primarily of interest expense related to outstanding debt obligations, a one-time non-operating loss on a fraud incident, and other immaterial non-operating items.

Comparison of the years ended December 31, 2025 and 2024

The following table summarizes our results of operations for the years ended December 31, 2025 and 2024:

	For the Years Ended December 31,
	2025			2024			Change
Revenue	$	—		$	—		$	—
Operating expenses
Research and development		1,255,266			2,103,366			(848,100	)
General and administrative		2,512,470			1,917,154			595,316
Depreciation		4,634			6,300			(1,666	)
Total operating expenses		3,772,370			4,026,820			(254,450	)
Loss from operations		(3,772,370	)		(4,026,820	)		254,450
Other income (expense), net
Interest income		25,614			142,596			(116,982	)
Interest expense		(100,881	)		(5,000	)		(95,881	)
Realized loss on investment		—			(722	)		722
Loss on fraud incident		—			(1,042,459	)		1,042,459
Other income		—			77,000			(77,000	)
Total other income (expense), net		(75,267	)		(828,585	)		753,318
Net loss	$	(3,847,637	)	$	(4,855,405	)	$	1,007,768

Research and development expenses

The following table summarizes our R&D expenses for the years ended December 31, 2025 and 2024:

	For the Years Ended December 31,
	2025		2024		Change
Personnel-related expenses	$	1,158,074	$	1,793,458	$	(635,384	)
Clinical and preclinical expenses		82,016		262,833		(180,817	)
Other expenses		15,176		47,075		(31,899	)
Total research and development expenses	$	1,255,266	$	2,103,366	$	(848,100	)

Research and development expenses were approximately $1.3 million for the year ended December 31, 2025, compared to $2.1 million for the year ended December 31, 2024, representing a decrease of approximately $0.8 million. This decrease was primarily attributable to an approximately $0.6 million reduction in workforce-related expenses, driven by a voluntary reduction in employee compensation, a decrease in headcount, and the reclassification of a portion of salary expenses following the promotion of our Chief Operating Officer to Chief Executive Officer in 2025. As a result of this change in role and responsibilities, approximately 60% of this individual’s compensation was reallocated to general and administrative expenses. The reductions were partially offset by an increase in stock-based compensation of approximately $0.5 million.

In addition, research and development expenses decreased by approximately $0.2 million due to lower clinical costs and development costs, including reduced spending on clinical supplies, formulation activities, regulatory support, and preclinical contract research, consulting services, and travel.

General and administrative expenses

The following table summarizes our general and administrative expenses for the years ended December 31, 2025 and 2024:

	For the Years Ended December 31,
	2025		2024		Change
Personnel-related expenses	$	1,084,329	$	510,396	$	573,933
Professional services		898,044		754,503		143,541
Corporate expenses		378,341		499,017		(120,676	)
Facilities costs		151,756		153,238		(1,482	)
Total general and administrative expenses	$	2,512,470	$	1,917,154	$	595,316

General and administrative expenses were approximately $2.5 million for the year ended December 31, 2025, compared to approximately $1.9 million for the year ended December 31, 2024, representing an increase of approximately $0.6 million. The increase was primarily driven by an approximately $0.6 million increase in personnel-related expenses, largely attributable to higher stock-based compensation. The increase in personnel-related expenses also reflects approximately $0.1 million resulting from the reclassification of a portion of salary expenses following the promotion of our Chief Operating Officer to Chief Executive Officer in 2025, with approximately 60% of that individual’s compensation allocated to general and administrative expenses. These increases were partially offset by a reduction in workforce-related expenses, including a voluntary reduction in employee compensation and related costs of approximately $0.1 million.

Professional services expenses increased by approximately $0.1 million, primarily due to higher legal, audit, and other professional fees of approximately $0.4 million incurred in preparation for our proposed direct listing on the Nasdaq Capital Market, partially offset by a reduction in patent-related costs of approximately $0.3 million.

Corporate expenses decreased by approximately $0.1 million, primarily reflecting lower fundraising-related costs and board-related costs of approximately $0.2 million. Facility costs remained relatively consistent year over year.

Other income (expense), net

Other income (expense), net was approximately $(0.1) million for the year ended December 31, 2025, compared to approximately $(0.8) million for the year ended December 31, 2024, representing a favorable change of approximately $0.7 million. This improvement was primarily attributable to the absence of a one-time loss related to a fraud incident of approximately $1.0 million recorded during the year ended December 31, 2024. The favorable impact was partially offset by lower interest income of approximately $0.1 million, higher interest expense of approximately $0.1 million, and the absence of a one-time receipt of approximately $0.1 million recognized during the year ended December 31, 2024.

Liquidity and Capital Resources

Sources of Liquidity

Since our inception, we have not generated revenue from product sales and have incurred significant operating losses and negative cash flows from operations. We expect to continue to incur substantial losses and use significant cash resources for the foreseeable future as we advance the development of our product candidates.

To date, we have financed our operations primarily through the sale of convertible preferred stock, common stock, and convertible debt. Through December 31, 2025, we have received aggregate gross proceeds of $46.1 million from these financing activities.

As of December 31, 2025, we had cash and cash equivalents of approximately $0.2 million. Based on our current operating plan, these capital resources, together with expected net proceeds from our ongoing private placement memorandum (PPM) offering, are expected to fund our operations for at least 12 months from the date of listing. However, these estimates are based on assumptions that may prove to be inaccurate, and actual results may differ materially. As such, there is substantial doubt about our ability to continue as a going concern.

Our audited financial statements for the years ended December 31, 2025 and 2024 include an explanatory paragraph from our independent registered public accounting firm stating that our recurring losses from operations raise substantial doubt about our ability to continue as a going concern.

Our continued operations will depend on our ability to raise additional capital through equity offerings, debt financings, collaborations, or other strategic arrangements. There can be no assurance that such additional financing will be available on acceptable terms, or at all.

Future Funding Requirements

We anticipate that our expenses will increase significantly as we:

●

Advance our lead product candidate, Nu-3, through clinical development;

●

Continue preclinical development of additional pipeline candidates;

●

Seek regulatory approvals for our product candidates;

●

Build our commercial infrastructure to support future product launches, if approved;

●

Expand our operational, financial, legal, and compliance functions as a public company;

●

Strengthen our intellectual property portfolio; and

●

Hire additional personnel in research, clinical, regulatory, quality, and administrative functions.

Our future capital requirements will depend on many factors, including:

●

The scope, progress, and timing of our Nu-3 clinical trial;

●

The costs, design, and duration of any additional preclinical and clinical trials;

●

Manufacturing scale-up expenses, including establishment of commercial supply;

●

Regulatory feedback and approval pathways in the U.S. and internationally;

●

The timing and terms of any future in-licensing or acquisition transactions;

●

The costs of maintaining and protecting our intellectual property portfolio;

●

The need for additional personnel and infrastructure as we grow;

●

The level of market acceptance and third-party reimbursement of any future approved products;

●

The extent to which we enter into strategic collaborations, partnerships, or licensing arrangements; and

●

Any milestone or royalty payments required under existing or future agreements.

Until such time, if ever, that we are able to generate revenue from product sales, we expect to continue financing our operations through the sale of equity securities, debt financings, government or private grants, and/or licensing or collaboration arrangements.

Should we raise additional funds through the issuance of equity or convertible debt securities, existing stockholders may experience dilution, and the new securities may contain rights, preferences, or privileges senior to those of existing holders. Debt financing, if available, may impose restrictive covenants, and collaboration agreements may require us to relinquish valuable rights to our technologies or future revenue streams.

If we are unable to obtain adequate financing when needed, we may be required to delay, limit, reduce, or terminate our research and development programs or future commercialization efforts, or enter into strategic transactions on unfavorable terms, or cease operations entirely.

Material Cash Requirements from Known Contractual and Other Obligations

Leases

We lease office space in University Park, Florida, under a non-cancelable operating lease that expires on April 30, 2027. For additional information, refer to Note 5 to our audited financial statements included elsewhere in this filing.

Research and Development Commitments

We expect to continue to incur substantial costs related to the ongoing clinical development of Nu-3 and other pipeline candidates. We are in the final stages of entering into new contractual commitments with CROs to support clinical trial execution. Each contract typically remains in effect through the completion of the respective clinical trial. Costs will vary depending on trial size, duration, and scope of services.

We also anticipate continued investments in preclinical development, manufacturing, and regulatory activities to support our broader pipeline.

Cash flows

For the years ended December 31, 2025 and 2024

The following table provides information regarding our cash flows for the years ended December 31, 2025 and 2024:

	For the Years Ended December 31,
	2025			2024
Net cash used in operating activities	$	(1,944,698	)	$	(5,723,322	)
Net cash provided by investing activities		—			3,924,664
Net cash provided by (used in) financing activities		1,500,000			(50,000	)
Net decrease in cash and cash equivalents	$	(444,698	)	$	(1,848,658	)

Operating Activities

Net cash used in operating activities was approximately $1.9 million for the year ended December 31, 2025, compared to approximately $5.7 million for the year ended December 31, 2024, representing a decrease of approximately $3.8 million. The decrease was primarily due to a lower net loss and more favorable working capital changes in the current year. For the year ended December 31, 2025, cash used in operating activities was primarily driven by a net loss of approximately $3.8 million, partially offset by approximately $1.9 million in non-cash charges and favorable changes in operating assets and liabilities. Non-cash adjustments primarily consisted of stock-based compensation expense. Changes in working capital were primarily driven by an increase in trade payables and accrued liabilities, partially offset by a reduction in lease liability.

In comparison, for the year ended December 31, 2024, net cash used in operating activities of approximately $5.7 million was primarily driven by a net loss of approximately $4.8 million and unfavorable changes in operating assets and liabilities of approximately $1.2 million, mainly related to reductions in trade payables and accrued liabilities. These were partially offset by non-cash charges, primarily stock-based compensation expense.

Investing Activities

There were no investing activities during the year ended December 31, 2025.

For the year ended December 31, 2024, net cash provided by investing activities was approximately $3.9 million. These amounts primarily reflected proceeds from the maturity of short-term investments and sale of an investment, partially offset by purchases of such investments.

Financing Activities

Net cash provided by financing activities was approximately $1.5 million for the year ended December 31, 2025. These proceeds were received through a financing, initially consisting of approximately $0.2 million in short-term promissory notes bearing interest at 10% per annum. These notes were subsequently converted into short-term convertible promissory notes under the same interest terms. In total, the Company raised $1.5 million during the year through the issuance of short-term convertible promissory notes, all bearing interest at a rate of 10% per annum.

Net cash used in financing activities for the year ended December 31, 2024 was $50 thousand, attributable to the repurchase of company stock.

Proposed Convertible Financing

The Company has agreed to the terms of a financing of newly created shares of Series C Convertible Preferred Stock (the “Series C Preferred”) as set forth below:

●

Offering of $7,500,000 of Series C Convertible Preferred Stock at an original issuance price of $10.00 per share and original issue discount of 20%.

●

Each share of Preferred Stock is convertible at the option of the holder, at any time and from time to time, at a conversion price that is the lesser of $10.00 per share or a 20% discount to the trailing 5-day average closing price, with a floor of $1.00, resulting in a maximum number of Common Stock of 9,375,000.

●

The closing will take place on the date of the filing for acceleration of this Registration Statement.

●

Officers, Directors, and holders of 10% or more of the Company’s issued and outstanding shares of common stock are subject to a lockup period of the lesser of (i) 180 days from the closing date or (ii) the date of full conversion of the Series C Preferred.

●

All beneficial owners of more than 5% of the Company’s unregistered common stock are subject to a lockup period of the lesser of (i) 180 days from the closing date or (ii) the date of full conversion of the Series C Preferred.

●

The Company will be obligated to file a registration statement registering for resale the shares of common stock underlying the Series C Preferred.

●

The Company shall not issue any type of equity or equity-linked securities without the prior written consent of the Investor before (i) 180 days from the closing date or (ii) the date of full conversion of the Series C Preferred without the written consent of the Series C Preferred investor.

●

The Investor shall be entitled to receive dividends at the rate of ninety-six cents ($0.96) per share per annum, or 9.6% per annum of the liquidation preference of eight dollars ($10.00) per share on the Series C Preferred that have not been converted commencing 180 days from the closing date.

Critical Accounting Policies and Significant Judgments and Estimates

Our financial statements are prepared in accordance with U.S. generally accepted accounting principles (“GAAP”). The preparation of these financial statements requires us to make estimates and judgments that affect the reported amounts of assets, liabilities, expenses, and related disclosures, including the disclosure of contingent assets and liabilities. We evaluate our estimates and assumptions on an ongoing basis. Estimates are based on historical experience, known trends, and other relevant factors believed to be reasonable under the circumstances. Actual results may differ materially from those estimates.

While our significant accounting policies are described in more detail in Note 2 to our financial statements included elsewhere in this filing, we believe that the following accounting policies involve the most significant judgments and estimates used in the preparation of our financial statements.

Research and Development Expenses and Related Prepaid and Accrued Expenses

We recognize research and development (“R&D”) expenses as incurred. These expenses consist primarily of costs incurred in connection with the development of our product candidates, including services performed by third-party contract research organizations (“CROs”), contract manufacturing organizations (“CMOs”), consultants, and other external vendors, as well as internal personnel costs.

Advance payments for goods or services to be used in future R&D activities are deferred and recognized as expenses when the related services are performed or when the goods are received.

Stock-Based Compensation

We account for stock-based compensation in accordance with ASC 718, Compensation — Stock Compensation. We recognize expense for all equity-based awards, including stock options granted to employees, directors, and consultants, based on the grant-date fair value of the awards. The fair value of stock options is estimated using the Black-Scholes option-pricing model. Compensation cost is recognized on a straight-line basis over the requisite service period, which is typically the vesting period of the respective awards.

The determination of grant-date fair value requires management to make several assumptions, including:

●

Risk-free interest rate: Based on U.S. Treasury yields with maturities similar to the expected term of the options at the date of grant.

●

Dividend yield: Assumed to be zero, as we have never declared or paid dividends and do not anticipate doing so in the foreseeable future.

●

Expected term: Estimated using the simplified method, which calculates the average between the vesting date and the contractual term of the option.

●

Expected volatility: Based on the historical volatilities of a group of comparable public companies, as we do not have sufficient trading history of our common stock.

●

Fair value of common stock: Determined based on valuations performed by third-party valuation specialists, considering recent financings and other relevant market data.

These assumptions require significant judgment, and changes in these inputs could materially affect the fair value of future grants and related stock-based compensation expense.

Refer to Note 8 of our financial statements included elsewhere in this filing for additional information regarding the assumptions used in the Black-Scholes model and stock option activity during the periods presented.

As of December 31, 2025, there was no intrinsic value associated with the outstanding stock options.

Determination of Fair Value of Our Common Stock

Prior to the listing of our common stock on a public securities exchange, there had been no public market for our common stock, and, as such, the fair value of our common stock for financial reporting purposes was determined by our Board of Directors with the assistance of management and third-party valuation specialists. The fair value was estimated based on a variety of factors in accordance with the guidelines outlined in the American Institute of Certified Public Accountants Practice Aid, Valuation of Privately Held Company Equity Securities Issued as Compensation.

Our valuations were performed using methodologies that comply with the option-pricing method (“OPM”). These methods consider a range of objective and subjective factors, including:

●

The prices of preferred stock sold to outside investors in arms-length transactions and the rights, preferences, and privileges of the preferred stock relative to common stock;

●

Our historical and projected financial performance and key milestones;

●

The development status of our product candidates, including data from clinical trials and regulatory milestones;

●

The lack of marketability of our common stock;

●

The industry outlook and performance of comparable publicly traded peer companies;

●

The likelihood and timing of a potential liquidity event, such as an initial public offering or sale of the company;

●

General U.S. and global economic and capital market conditions.

After the valuation is performed, our Board of Directors reviews and approves the estimated fair value of our common stock based on the recommendation of management and the analysis provided by our third-party valuation firm.

Following the listing of our common stock, the fair value of our common stock is based on the quoted closing price of our shares on the applicable trading market.

We believe that the methodologies used to determine the estimated fair value of our common stock are consistent with the guidance prescribed by the Financial Accounting Standards Board under ASC 718 and are reasonable for financial reporting purposes.

Off-Balance Sheet Arrangements

We did not have, during the periods presented, and we do not currently have, any off-balance sheet arrangements, as defined under SEC rules, such as relationships with unconsolidated entities or financial partnerships, including structured finance or special purpose entities, that have been established for the purpose of facilitating off-balance sheet arrangements or other contractually narrow or limited purposes.

Recently Issued Accounting Standards

A description of recently issued accounting standards that may potentially impact our financial position, results of operations, or cash flows is included in Note 2 to our financial statements included elsewhere in this filing.

Emerging Growth Company and Smaller Reporting Company Status

We are an “emerging growth company,” as defined in the Jumpstart Our Business Startups Act of 2012, or the JOBS Act. As an emerging growth company, we may take advantage of certain exemptions from various reporting and other requirements that are applicable to other public companies that are not emerging growth companies. These exemptions include:

●

reduced disclosure obligations regarding executive compensation;

●

no requirement to hold nonbinding advisory votes on executive compensation or golden parachute arrangements;

●

an exemption from the auditor attestation requirement of Section 404(b) of the Sarbanes-Oxley Act; and

●

delayed adoption of new or revised accounting standards applicable to public companies until such standards are also applicable to private companies.

We have elected to take advantage of the extended transition period to comply with new or revised accounting standards. As a result, our financial statements may not be comparable to those of companies that comply with public company effective dates.

We will remain an emerging growth company until the earliest of:

●

the last day of the fiscal year in which we have total annual gross revenues of $1.235 billion or more;

●

the last day of the fiscal year in which the market value of our common stock held by non-affiliates is $700 million or more as of the last business day of our second fiscal quarter;

●

the date on which we have issued more than $1.0 billion in nonconvertible debt over a three-year period; or

●

the last day of the fiscal year following the fifth anniversary of the completion of this offering.

We are also a “smaller reporting company,” as defined in Rule 12b-2 of the Exchange Act, meaning that we have either (i) less than $250 million of public float, or (ii) less than $100 million in annual revenues and less than $700 million of public float. As a smaller reporting company, we may take advantage of many of the same reduced disclosure obligations available to emerging growth companies, including reduced disclosure obligations regarding executive compensation.

Quantitative and Qualitative Disclosures About Market Risk

Interest Rate Risk

We are exposed to market risk related to changes in interest rates. As of December 31, 2025, our cash and cash equivalents consisted primarily of cash held in checking and money market accounts. Because of the short-term nature of these instruments, we do not believe a sudden change in interest rates would have a material effect on our financial condition or results of operations.

Foreign Currency Exchange Risk

We currently operate primarily in the United States, and all current transactions conducted by the company are transacted in US dollars and do not have significant exposure to foreign currency exchange risk. However, as we expand clinical activities globally, our exposure to exchange rate fluctuations may increase, particularly with respect to the Euro and other non-U.S. currencies. To date, we have not entered into any foreign currency exchange contracts or other hedging strategies. We do not believe that a hypothetical 10% increase or decrease in exchange rates would have had a material effect on our financial results during the periods presented.

Effects of Inflation

Inflation may increase our cost of operations, particularly labor and research and development expenditures. While inflation has not materially affected our business or results of operations during the periods presented, we continue to monitor its potential impact on future financial performance.

BUSINESS

Stockholders should read this section in conjunction with the more detailed information about the Company contained in this prospectus, including our audited financial statements and the other information appearing in the section entitled “Management’s Discussion and Analysis of Financial Condition and Results of Operations.”

General

Antimicrobial resistance (AMR) represents a growing global health crisis, responsible for 1.27 million deaths annually and contributing to nearly 5 million deaths worldwide. The rapid rise of resistant pathogens has rendered many existing antibiotics ineffective, increasing the risk of severe infections, prolonged hospital stays, and substantial economic burdens. Despite this urgent need, the development of new antibiotics has slowed, with most advancements occurring within existing drug classes, leaving them vulnerable to resistance mechanisms.

Lakewood-Amedex Biotherapeutics Inc., a privately held pharmaceutical company, is addressing this crisis with the development of its Bisphosphocin^® class of antimicrobial agents. Unlike traditional antibiotics, Bisphosphocin^® compounds are being developed with a novel mechanism of action that is designed to destabilize bacterial membranes within minutes, potentially significantly reducing the likelihood of resistance development. This unique approach is designed to make them highly active against a broad spectrum of Gram-positive, Gram-negative, and drug-resistant pathogens, including methicillin resistant Staphylococcus aureus (MRSA) and multidrug-resistant Gram-negative bacteria. The available non-clinical data will need to be confirmed in clinical studies and evaluated by the FDA and comparable regulatory authorities.

The lead compound, Nu-3, is currently advancing through clinical trials for the treatment of infected diabetic foot ulcers (iDFU), a major complication affecting millions of diabetic patients worldwide. Nu-3 is formulated as a topical gel, and based on in vitro and in vivo non-clinical data, potentially offering several advantages over systemic antibiotics, including:

●

Rapid and potent antimicrobial action

●

Broad-spectrum activity, including against resistant bacterial strains.

●

Targeted delivery at the infection site, overcoming circulation challenges in diabetic patients.

●

No expected resistance development

●

Minimal systemic exposure, reducing side effects.

Beyond iDFU, Lakewood-Amedex Biotherapeutics Inc. is exploring additional local drug delivery applications, including complicated urinary tract infections (CAUTI) and pulmonary infections.

A. Introduction to AMR

Antimicrobial resistance (AMR) continues to pose a significant global public health threat, ranking among the top 10 challenges faced by humanity. A Lancet publication in 2022 on the global burden of AMR, with the latest data from 2019, reported that 4.95 million deaths were associated with antimicrobial resistance and that 1.27 million deaths were directly attributable to AMR.⁶ The Centers for Disease Control and Prevention (CDC) reported that in the U.S. alone, more than 2.8 million AMR infections occur each year, with more than 35,000 deaths as a result.⁷

Antimicrobial resistance is a growing global threat and may lead to a future pandemic affecting humanity.⁸Beyond its devastating impact on human lives, AMR also jeopardizes the global economy, with implications for international trade, health care expenditures, and overall productivity. If left unaddressed, by 2050, the economic toll of AMR could reach a staggering $3.8 trillion in global gross domestic product (GDP) loss. Treatment of infections caused by the six leading multi-drug-resistant germs cost more than $4.6B in 2021 in the U.S.⁹

Antimicrobial Resistance Collaborators. (2022). Global burden of bacterial antimicrobial resistance in 2019: a systematic analysis. The Lancet; 399(10325): P629-655. DOI: https://doi.org/10.1016/S0140-6736(21)02724-0.

Antibiotic Resistance Threats in the United States, 2019, Atlanta, GA: U.S. Department of Health and Human Services, CDC (2019 Antibiotic Resistance Threats Report | Antimicrobial Resistance | CDC).

World Bank. 2017. “Drug-Resistant Infections: A Threat to Our Economic Future.” Washington, DC: World Bank. License: Creative Commons Attribution CC BY 3.0 IGO

Nelson et al, National Estimates of Healthcare Costs Associated With Multidrug-Resistant Bacterial Infections Among Hospitalized Patients in the United States, 2021, Clinical Infectious Disease, 2021, 72, S17–26.

AMR is a natural process that happens over time through genetic changes in pathogens. Microbes have several biological mechanisms to induce resistance and promote their survival in the presence of antibiotics and antifungals, and these mechanisms are categorized into four distinct types: 1) preventing antibiotic uptake; 2) modification of the drug target; 3) inactivation of the drug; or 4) removal of the drug through efflux pumps.¹⁰

As a result of drug resistance, antibiotics and antifungal medicines become ineffective and infections become difficult or impossible to treat, increasing the risk of disease spread, severe illness, disability, and death. AMR emergence and spread are accelerated by human activity, particularly in less developed countries. This situation is predominantly linked to the misuse and/or overuse of antimicrobials to treat, prevent, or control infections in humans, animals, and plants (entering the food chain). The discovery and launch of antimicrobial drugs has slowed to a trickle, while resistant organisms have emerged for most classes of drugs. It is clear that new classes of AMR drugs are urgently needed.¹¹

The urgent need for effective antimicrobial drugs is further highlighted by increasing resistance trends. The 2022 World Health Organization (WHO) report on the Global Antimicrobial Resistance and Use Surveillance System (GLASS) report revealed alarming levels of resistance.¹² The resistance rate towards cephalosporin exceeds 50% in Klebsiella pneumoniae, which typically necessitates the use of carbapenems (i.e., “Reserve” antibiotics), while over 50% resistance towards carbapenems in Acinetobacter spp. leaves patients with very few options. Over 60% of N. gonorrhoeae isolates showed resistance to ciprofloxacin, one of the most frequently prescribed oral antibacterials. Similarly, more than 20% of isolates of E. coli, the primary pathogen responsible for urinary tract infections (UTIs), demonstrate resistance to both first-line (ampicillin and co-trimoxazole) and second-line (fluoroquinolone) treatment. While some resistance trends have remained stable over the past 4 years, the rates of bloodstream infections (BSI) caused by resistant E. coli, Salmonella spp., and resistant N. gonorrhoeae infections have increased by at least 15% compared to 2017 figures. Most septic conditions originate from a localized infection that is either misdiagnosed, diagnosed too late, or progresses due to the presence of resistant pathogens. Therefore, it is crucial to prevent a locally treatable infection from becoming systemic by providing effective treatment options for local drug delivery against resistant pathogens.

So far, most new drug developments have occurred in the existing classes of antibiotics, but the new drugs in these classes are susceptible to the same drug resistance mechanisms and are therefore likely to be only temporary solutions; novel drugs from totally new mechanistic classes are urgently needed. In addition to resistance development in bacteria, an increasing concern is a similar development for fungal infections.

B. Bisphosphocin^® Overview

All the data presented in the following sections B a)- f) were obtained from non-clinical in vitro or in vivo experiments. The Company acknowledges that the results from preclinical studies may not be reproduced in clinical trials and that the outcomes of clinical trials are inherently uncertain.

Lakewood-Amedex Biotherapeutics Inc. has discovered a new class of antimicrobials, the Bisphosphocin^® class, being developed with a unique mechanism of action designed to overcome the problem of resistance emergence. Several examples of the class have been extensively profiled non-clinically for their antimicrobial properties, and one member — Nu-3 — has been advanced into the clinic. The physicochemical properties of the Bisphosphocin^® class make them suitable for a wide range of local drug delivery options, such as gel formulations for skin infections, solution formulations for complicated urinary tract infections (cUTI), and solution formulations as aerosols for the treatment of pulmonary infections with the use of a nebulizer. The direct application at the site of infection has the advantage of rapid antimicrobial action, limited systemic exposure, and hence avoidance of most or all systemic side-effects known from systemic antibiotic therapies, such as gastrointestinal side effects and disruptive effects on the intestinal microbiome. Most importantly, initial in vitro data suggest that the novel mechanism of action (see below) makes the possibility of resistance emergence less likely. Our goal is to develop our Bisphosphocin^® compounds to become a valuable and important treatment option for locally treatable infections.

Reygaert W C, An overview of antimicrobial resistance mechanisms of bacteria, AIMS Microbiology, 2018, 4 (3), 482-501.

Antibiotic Resistance Threats, CDC, 2019, Antibiotic Resistance Threats in the United States, 2019.

Global antimicrobial resistance and use surveillance system (GLASS) report 2022, ISBN 978-92-4-006270-2 (electronic version), ISBN 978-92-4-006271-9 (print version)

a) Mechanism of Action

Figure 1: A schematic representation of the mechanism of action of the Bisphosphocin^® class of compounds

The Bisphosphocin^® class of compounds is rapidly cidal in vitro to bacteria through a pH and concentration dependent destabilization of the bacterial cell membrane (see Figure 1 for a schematic of the mechanism), typically achieving this effect in under one minute of exposure. As evidence for the mechanism, exposure of bacteria to increasing concentrations of Nu-3 allows SYTOX green nucleic acid stain to accumulate inside bacterial cells, which is indicative of cell membrane depolarization/destruction and is correlated with the loss of bacterial cell viability (see Figure 2).¹³


Figure 2a		Figure 2b

Figure 2: Bacterial Cytological Profiling (BCP) of Nu-3: E. coli cells were treated with increasing concentrations of Nu-3 and then stained with SYTOX green. Figure 2a shows the time and concentration dependent SYTOX staining, and Figure 2b shows the staining photos, where red staining shows the bacterial membrane, blue staining shows bacterial DNA, and green staining indicates cell membrane disruption.

Lakewood-Amedex Biotherapeutics Inc. data

The activity of the Bisphosphocin^® class of compounds is pH dependent, with the greatest potential potency and activity at low pH values — pH 2 to 4. Compounds with a larger pH range for activity provide an opportunity to match different compounds to different indications, where the pH of the drug delivery formulation can be adjusted to suit the target organ. For example, the skin is more tolerant of lower pHs, whereas formulations designed for the bladder should be at a higher pH — typically > 3.5. Other properties of the Bisphosphocin^® class may also play a role in the tolerance of various tissues to the class.

b) Antibacterial Spectrum

Bisphosphocin^® compounds exhibit a broad-spectrum in vitro antibacterial activity against gram positive, gram negative, and the most relevant resistant bacterial strains, such as MRSA and other resistant pathogens. A partial list of bacteria that are susceptible to Nu-3 and other Bisphosphocin^® compounds is shown in Figure 3 (bacteria shown in red are AMR organisms).¹⁴ Research indicates that the antimicrobial properties of Bisphosphocin^® compounds are effective against several biodefense pathogens, thereby potentially playing a role in national security and public health.

Nosocomial Bacteria		Community Acquired Bacteria
Acinetobacter iwoffii – clinical isolate		Aeromonas hydrophilia – clinical isolate
Acinetobacter baumannii – clinical isolate		Alcaligenes faecalis – clinical isolate
Clostridium difficile – multi-resistant		Borellia burgdorferi
Enterococcus faecalis – W.T. & vancomycin resistant		Haemophilus influenzae
Enterococcus faecium – vancomycin resistant		Mycobacterium tuberculosis – W.T. & MDR
Klebsiella pneumoniae – clinical isolate, NDM-1		Moraxella catarrhalis
Pseudomonas aeruginosa – W.T.		Neisseria meningitidis – rifampicin resistant
Pseudomonas aeruginosa – ciprofloxacin, MDR		Propionibacterium acnes
Serratia marcessens – oxacilllin resistant		Proteus mirabalis
Staphylococcus aureus (MRSA) – vancomycin resistant		Streptococcus pneumoniae – penicillin resistant
Staphylococcus epidermis – oxacillin resistant

*Biodefense Organisms*		Yeast/Fungal Organisms
Bacillus anthracis		Trichophytan rubrum and mentagrophytes
Brucella abortus		Microsporum gypseum
Burkholderia mallei		Aspergillus fumigatus
Burkholderia pseudomallei		Candida albicans
Francisella tularensis		Saccharomyces pastorianis
Yersinia pestis

Lakewood-Amedex Biotherapeutics Inc. data

Figure 3: Organisms in red are AMR organisms

c) Rapid antibacterial effects

In in vitro time kill experiments where bacteria are exposed to the Bisphosphocin^® class of compounds, the cidal action is rapid, with total cell death occurring within minutes at higher concentrations and lower pH values. For example, Nu-3 kills 10⁵ E. coli bacteria within 10 minutes at 25 mg/ml (2.5% solution) and leads to complete eradication in less than 10 minutes at higher concentrations (see Figure 4). Additional bacterial time kills are shown in Figure 5, demonstrating the rapid time kill for a range of bacteria, including AMR strains.¹⁵

Figure 4: In vitro kill kinetics of Nu-3 against E. coli at three different concentrations of Nu-3

Nu-3 concentration required to kill 100%
Bacterium	AMR	1 min	10 min
Bacterium	AMR	mg/ml
E. coli (Uropath)	þ	>20	10
E. coli	Methicillin	-	5 – 10
K. pneumoniae	Susceptible	5	2.5
P. mirabilis	MDR	>20	5
A. baumannii	Sulphamethoxazole	10	2.5
P. aeruginosa	Susceptible	5	1.25
S. aureus	þ	?	?
S. saprophyticus	MDR	2.5	1.25

Lakewood-Amedex Biotherapeutics Inc. data

Figure 5: Time kill of Nu-3 against a range of bacteria at 1 and 10 min

The time-kill assays presented in Figures 4 and 5 were executed by incubating a bacterial culture (approximately 1.0 x 10⁵ CFU/ml in saline) with Nu-3 at the indicated concentrations in Eppendorf tubes, which were kept at room temperature. The surviving bacteria were quantified at 1, 5, 10, and 20 minutes after the incubation period through serial dilution and plating on agar plates.¹⁶In additional in vitro experiments with two other members of the class of antimicrobials, Nu-10 and Nu-11, both compounds showed faster times to kill 100% of E. coli and S. aureus, and at lower concentrations than Nu-3 as shown in Figure 6.

Compound	Species	Strain	Concentration (mg/mL)	Time to 100% kill (min)
Nu-10	E. coli	ATCC 25922	25	<1
Nu-10	E. coli	ATCC 25922	5	5
Nu-11	E. coli	ATCC 25922	25	<1
Nu-11	E. coli	ATCC 25922	1	<1
Nu-10	S. aureus	ATCC 43300	25	<1
Nu-10	S. aureus	ATCC 43300	5	20
Nu-11	S. aureus	ATCC 43300	25	5
Nu-11	S. aureus	ATCC 43300	5	10

Figure 6: Time kill for 100% reduction of E. coli and S. aureus for Nu-10 and Nu-11 at a range of concentrations.

d) Effects on Biofilm

Biofilm formation is a method used by bacteria to evade antibiotics and survive in hostile conditions. It has been identified as a major problem associated with chronic, recurrent, and resistant infections. The majority of the SOC antibiotics demonstrated reduced efficacy against bacteria that have entered a non-replicating state, commonly referred to as dormancy.¹⁷ Recent research indicates that Bisphosphocin^® compounds are effective at killing bacteria even when present in a biofilm environment where bacteria are in a quiescent or dormant state (see Figure 7 for the effect of Nu-3 on S. epidermidis biofilm growth).¹⁸

Figure 7: Increasing concentrations of Nu-3 block S. epidermidis growth and biofilm. Bacteria were grown in the presence or absence of Nu-3 in glass culture tubes for 48h. After visualizing the growth, the media were removed and then stained with a crystal violet stain to visualize biofilm formation.

Lakewood-Amedex Biotherapeutics Inc. data

Kahn et al, Challenges of Antibiotic Resistance Biofilms and Potential Combating Strategies; A Review, Biotech., 2021, 11, 169.

Aikiyoshi et al, 53^rd ICAAC Conference, 2013

e) No Resistance Development

The rapid membrane antimicrobial mode of action of Bisphosphocin^® compounds presents a challenge to resistance development by bacteria, which has been supported by in vitro laboratory experiments using a serial passage of E. coli and MRSA in the presence of Nu-3 for 21 days. The Minimum Inhibitory Concentrations (MICs) for Nu-3 were slightly increased at the end of the experiment for E. coli and unchanged for S. aureus. In contrast, the MIC of the ciprofloxacin control had increased over 2,000-fold for E. coli and over 600-fold for MRSA (see Figure 8). The initial MIC values of 10 mg/ml for Nu-3 were unchanged when assessed against bacteria resistant to Ciprofloxacin, which implies that cross-resistance did not occur.¹⁹

Figure 8: Nu-3 exhibits minimal or no tendency to develop resistance to E. coli and MRSA, whereas ciprofloxacin showed a 2,000-fold and 600-fold decrease in activity to E. coli and MRSA.

f) Minimal systemic exposure and side effects

The Bisphosphocin^® class of compounds is designed for application at the site of infection. In addition to the advantage of being able to target the infection directly, the local application is also designed to provide for limited systemic exposure and hence avoidance of most or all systemic side-effects, such as severe allergic reactions and gastrointestinal side effects that would otherwise occur through disruption of the intestinal microbiome and disruption of gut/intestinal microbiome with subsequent impairment of the immune system. Lakewood-Amedex Biotherapeutics Inc. has demonstrated in vivo that local application produces limited systemic exposure in several animal models, including a large animal porcine toxicology study where Nu-3 was applied to the wounds, in a twice-a-day regimen, for 14 days. Systemic exposure in this study was very low and short-lived, with no adverse effects on any organ system.²⁰ Quantitative testing (pharmacokinetics) of systemic exposure in humans is planned in the upcoming clinical trial.

g) Manufacturing aspects

The Bisphosphocin^® class of compounds is a modified nucleotide molecule and has excellent aqueous solubility, potentially making them adaptable to a range of different drug product formulations and delivery methods. Significant investment has been dedicated to the development of the manufacturing processes required to produce both the Bisphosphocin^® drug substances and drug products. Drug substance manufacturing process development has been conducted for several members of the class and has been carried out on a multikilogram scale under current Good Manufacturing Practices (cGMP) guidelines with high efficiency. In addition, process improvement efforts have reduced the cost of goods and have produced bulk drug substance with improved physical chemistry characteristics. Stability testing of the lead compound — Nu-3 — has shown the bulk drug substance material to be stable for at least five years. Similarly, drug product manufacturing process development has been conducted, and multikilogram quantities of the Nu-3 gel have been manufactured under cGMP guidelines, and the product is suitable for use in clinical trials. Stability testing of the Nu-3 formulation has shown the drug product to be stable for at least twenty-four months. In addition, initial testing for sterility and antimicrobial effectiveness has demonstrated that the drug product is sterile for at least eighteen months and does not require additional preservatives to maintain sterility.

Lakewood-Amedex Biotherapeutics Inc. data

Lakewood-Amedex Therapeutics Inc. data

Additional manufacturing development has been conducted for Nu-10, including process development and initial scale up production to 1 kg of Nu-10 drug substance. Drug product development of a solution formulation of Nu-10 has also been initiated with preliminary stability studies showing drug product stability for at least 6 months at 0-5ºC.

h) Indications

We believe that the Bisphosphocin^® class of compounds is suitable for the treatment of a range of indications. Lakewood-Amedex Biotherapeutics Inc. has a portfolio of compounds that are being profiled for indications such as infected diabetic foot ulcer, urinary tract infections, and pulmonary infections. Figure 9 shows the MIC values for Nu-3, Nu-8, Nu-10, and Nu-11, where Nu-10 and Nu-11 show improved in vitro activity as compared to Nu-3 and Nu-8, against bacteria that are found in both urinary tract and pulmonary infections. Nu-10 and Nu-11 are being further explored in preclinical testing as potential development compounds for the CAUTI or the pulmonary indication development. The decision whether one of the compounds is suited for either of the indications will largely be determined by animal toxicology studies that need to be performed to identify the most favorable benefit-risk profile, taking into consideration the local organ specific tissue conditions.

		MIC (mg/mL)
Species	Strain	Nu-03	Nu-08	Nu-10	Nu-11
A. baumannii	ATCC-19606	3.13	12.50	6.25	0.78
A. radioresistens	MMX-8551	3.13	6.25	6.25	0.78
C. freundii	CDC-0157	3.13	6.25	0.78	0.78
C. striatum	ATCC-6940	>100	3.13	0.39	0.20
E.coli	ATCC-25922	>100	70.63	4.94	3.96
E.coli	MMX-8870	6.25	25.00	6.25	1.56
E. faecalis	ATCC-29212	6.25	12.50	3.13	3.13
E. faecalis	MMX-3353	12.50	12.50	3.13	3.13
E. faecium	ATCC-35667	6.25	12.50	1.56	0.78
E. faecium	MMX-3355	6.25	12.50	1.56	1.56
H. influenzae	ATCC-49247	0.78	3.13	0.39	0.20
K. pneumoniae	ATCC-43816	NT	50.00	6.25	3.13
M. morganii	CDC-0519	6.25	12.50	1.56	0.78
P. aeruginosa	ATCC-27853	110.37	67.83	5.16	2.23
P. mirabilis	CDC-0155	6.25	6.25	1.56	0.78
S. agalactiae	ATCC-13813	1.56	>25	0.39	0.39
S. aureus	ATCC-29213	25.00	25.00	13.02	5.73
S. dysgalactiae	ATCC-6644	1.56	>25	0.39	0.39
S. epidermis	ATCC-12228	3.13	12.50	0.39	0.39
S. haemolyticus	ATCC-29970	6.25	12.50	0.39	0.78
S. marcescens	CDC-0521	3.13	25.00	1.56	1.56
S. pneumoniae	ATCC-49620	1.56	3.13	0.39	0.39
S. pneumoniae	MMX-8138	0.78	3.13	0.39	0.39
S. pyogenes	ATCC-49400	0.78	3.13	0.78	0.78
S. saprophyticus	ATCC-49908	6.25	6.25	0.39	0.39

Figure 9: MIC comparative data for Nu-3, Nu-8. Nu-10, and Nu-11 against a range of bacteria involved in urinary tract and pulmonary infections (NT = Not Tested).

Figure 10 shows a summary of the development status of the portfolio of compounds. Treatment of infected diabetic foot ulcer is the most advanced, and each indication will be further described below.

Figure 10: Current development status of the Lakewood-Amedex Biotherapeutics Inc. compounds

iDFU

Background

One compound — Nu-3 — is in the clinical phase for the selected lead indication of infected Diabetic Foot Ulcers (iDFU). Among the 830 million patients worldwide suffering from Diabetes,²¹ close to 40 million are in the US alone, and about one third of them will develop a diabetic foot ulcer (DFU) in their life, of which about 50% will be infected. Numerous patients experience more than one of these events in their lives. Additionally, a fifth of diabetic patients who have a foot ulcer will need amputation,²² and infections, if not contained, are an important additional risk factor alongside the presence of peripheral arterial disease, for future amputations.²³ This underlines the important role of an early and effective treatment of the infection in an early stage to prevent disease progression, including these devastating complications like amputations. The cost of care for diabetic foot ulcer complications exceeds the cost of treatment of the 5 most costly forms of cancer.²⁴

Global Data has reported the prevalence rates for DFU for many countries/regions, including the USA, Western Europe, India, China, and Brazil. (see Table 1).

Region	CAGR			2016		2020		2025		2030^a
USA^b		4.7	%		3,441,554		4,069,229		4,887,925		6,149,757
Europe^c		3.5	%		944,307		1,073,456		1,238,779		1,471,281
ROW^d		4.2	%		8,759,781		10,272,782		12,094,549		14,856,902
Total		4.3	%		13,145,642		15,415,467		18,221,253		22,477,940

Table 1: DFU Prevalence in millions of patients for the USA, Western Europe, India, China, and Brazil. Footnotes: a — calculated data; b = USA; c = France, Germany, Italy, Spain, UK; d = Canada, Australia, Brazil, China, India, Japan, Mexico, Russia, South Africa, and South Korea.

WHO report on Diabetes, 2024, https://www.who.int/news-room/fact-sheets/detail/diabetes.

Lipsky et al., Clin Infect Dis., 2012, 54, 132-173. doi: 10.1093/cid/cis34.

Armstrong D., et al., Diabetes Care, 1998, 21 (5), pp 855-859; Oyibo S.O., et al., Diabetes Care, 2001, 24, 84-88; Jia L., et al. PLoS ONE, 2017, 12 (5), pp 1-15, https://doi.org/10.1371/journal.pone.0177916.

Armstrong D., Swerdlow M.A., Armstrong A.A., Conte M.S., Padula V., and Bus, S.A., Five year mortality and direct costs of care for people with diabetic foot complications are comparable to cancer, J. Foot and Ankle Res., 2020, 13:16.

Diabetic foot ulcers (DFU) represent a complex and difficult to treat complication of diabetes mellitus. Besides external traumata, three major pathologic conditions appear to be the main contributors to the development of DFUs: ischemia, neuropathy, and infection. Consequently, the treatment of DFUs must consider all these factors and address them as applicable, in addition to proper wound care management, to heal the ulcer. Infection control is hence accepted to be a key success factor in facilitating healing and preventing disease progression to a more severe form of infection, which eventually may lead to amputation.

Curing an infection of a DFU is particularly challenging because i) the infection tends to be polymicrobial in nature, requiring a broad-spectrum antibiotic, ii) the ulcer is prone to re-infections, and iii) the pathogenic bacteria are increasingly becoming resistant to most front-line therapies. A recent meta-analysis suggests that resistant bacteria such as MRSA can be identified in 15-20% of patients with an infected diabetic foot ulcer.²⁵ Recent studies have also estimated that approximately 60% to 80% of chronic infections also involve the formation of biofilm. This contributes to the questionable effects of traditional antibiotics in the treatment of iDFU.²⁶

Today’s standard of care for mildly infected foot lesions includes traditional oral antibiotic therapy (empiric treatment with potential switch of therapy if suggested based on culture results) in addition to thorough wound care, including the use of off-loading restraints. Oral antibiotic therapy, however, is associated with several systemic side effects, such as allergic reactions, disturbance of the normal gut microbiome, and gastrointestinal problems. The biggest limitation, however, seems to be the limited effects of antibiotics in mild iDFU. The main reason for the development of diabetic foot ulcers is the poor perfusion due to peripheral artery disease, which affects the microcirculation in the more superficial tissue layers. For the same reason, it must be assumed that the use of oral medication like an antibiotic may not reliably lead to sufficient concentration of such an antibiotic in a peripheral and a more superficial foot ulcer. Existing guideline recommendations for the use of antibiotics are more an expression of infection stewardship, but are not supported by reliable data. To our knowledge, no data demonstrating an additive effect of oral antibiotics over proper wound care in mild iDFU are published, underlying the need for a more effective antimicrobial treatment and the benefit of local drug delivery to circumvent the problems related to poor perfusion in infection.

Lakewood-Amedex Biotherapeutics Inc.’s Lead compound Nu-3

Studies indicate that Nu-3, as a gel formulation, exhibits the most favorable combination of product features such as a broad spectrum and fast acting antimicrobial activity, including resistant strains; a very low likelihood of resistance development; a low likelihood of systemic side effects and direct effects on the infected area as a topical gel in a disease that is largely driven by poor perfusion and low susceptibility of systemic antibiotic treatments.

A rigorous phase 2 study protocol has been developed and has been fully aligned with the FDA to assess the potential use of Nu-3 gel in iDFU. These discussions resulted in a full alignment on design, eligibility criteria, as well as outcome measures/endpoints for this phase 2 b study. Recently, the Company decided, for business reasons, to first start with a smaller size phase 2a study to establish initial proof of concept in patients before moving into the originally planned phase 2b study. This single blind study will compare three different concentrations of Nu-3 gel, 2%, 5% and 10% with twice-a-day applications. Study population, eligibility criteria, and targeted endpoints are identical to the phase 2b study that has already been discussed and agreed upon with the FDA. Prior to the start of the phase 2a study, this protocol will also be added to the IND, and sufficient time for any additional FDA feedback has been built into the operational planning. Once a dose response curve has been established from this phase 2a study, which, if confirmed, would provide strong evidence for a positive proof of concept, the phase 2b study will follow and will be used to determine the final dose as well as the administration regimen (once-a-day vs twice-a-day) in comparison to placebo. (Details also disclosed on page 5)

Zhou et al, The Global Prevalence of Methicillin-Resistant Staphylococcus Aureus in Patients with Diabetic Foot Ulcers: A systematic Review and Meta-Analysis, Diabetes, Metabolic Syndrome and Obesity, 2024, 17, 563-574.

Pouget et al, Biofilms in Diabetic Foot Ulcers: Significance and Clinical Relevance, Microorganisms, 2020, 8, 1580.

Preclinical Bioactivity of Nu-3

Non-clinical research indicates that Nu-3 displays a broad spectrum of activity against the top ten typical microbial components of an infection of a diabetic foot ulcer. The MICs are summarized in Table 2. More recently, Nu-3 was tested against a range of recently isolated resistant and susceptible organisms, and Nu-3 showed similar MICs against the bacteria, indicating that the antibacterial activity remains robust (see Table 3). It is important to highlight that these MIC numbers were significantly lower, ranging from 8 to 50 times, than the one of the clinical doses (10% gel – 100 mg/ml) that will be studied in the clinical trial.

Bacterial Species		MIC (mg/ml)
Staphylococcus aureus		12.5 – 25
Staphylococcus epidermidis		3.125
Escherichia coli		6.25
Streptococcus dysgalactiae		1.56
Enterococcus faecalis		6.25
Staphylococcus haemolyticus		6.25
Proteus mirabilis		6.25
Pseudomonas aeruginosa		1.56
Acinetobacter radioresistens		3.125
Corynebacterium striatum		1.56
Serratia marcescens		3.125

Table 2: MIC₅₀ data for Nu-3 against the top 10 bacterial isolates from infections in DFU.

Species	Profile	MIC Range
Enterococcus faecalis	VSE(4)	6.25 – 12.5
Enterococcus faecalis	VRE(2)	6.25 – 12.5
Staphylococcus aureus	MSSA(5)	6.25
Staphylococcus aureus	MRSA(11)	3.125 – 12.5

Table 3: MIC₅₀ data for Nu-3 against recent clinical isolates.

VSE = Vancomycin susceptible Enterococci; VRE = Vancomycin resistant Enterococci;
MSSA = Methicillin susceptible S. aureus; MRSA = Methicillin resistant S. aureus.

Nu-3 has been profiled in several in vivo murine skin infection models. In a single-dose study comparing 10% Nu-3 solution vs. 10% Nu-3 gel, the gel outperformed the solution, showing complete inhibition at 1 and 8 hours post-infection in an infection treatment protocol using methicillin resistant S. aureus (MRSA) (see Figure 11a).²⁷ In a multiple dose study comparing once-a-day and twice-a-day dosing of both 5% and 10% gels with a 5-day recovery period, the gel formulations demonstrated effectiveness at the end of the recovery period with little to no reinfection (see Figure 11b).²⁸

Lakewood-Amedex Biotherapeutics Inc. data.

Figure 11a: Murine in vivo MRSA single dose skin infection model: A MRSA infection was introduced to skin abrasions and allowed to establish for 4 hours before applying the treatment — 10% Nu-3 gel, 10% Nu-3 solution, or placebo. The treated sites were then analyzed for bacterial growth at 1-, 2-, 4-, and 8-hours post-infection establishment.

Figure 11b: Murine in vivo MRSA multidose skin infection model: A MRSA infection was introduced to skin abrasions and allowed to establish for 4 hours before applying the treatment — 10% Nu-3 gel qd or bid, or 5% Nu-3 gel qd or bid, or placebo for 5 days, followed by 5-day observation as a recovery period. The treated sites were then analyzed for bacterial growth.

A porcine toxicology study to explore the effects of topical Nu-3 gel (up to 20%) on normal wound healing was conducted at multiples of the expected clinical doses for two weeks. No deleterious effects were seen on wound healing, and no skin sensitization was observed, clearing the way for doses of up to 10% Nu-3 to be used in the clinic.²⁹

Nu-3 Clinical Studies

An exploratory human trial on skin sensitization was conducted with Nu-3 solutions at 1 and 2% and no significant effects were observed. The same concentrations of Nu-3 solution were also studied in a small exploratory Phase1/2 study in iDFU patients where positive trends in the reduction of infection as well as a trend in wound area reduction were observed, supporting the further development of Nu-3.³⁰ A formulation switch from solution to gel was identified as an improvement and a gel formulation has been developed and patented which is supported by the murine data discussed in the previous section.

A new Phase 2b study in infected Diabetic Foot Ulcers has been designed and agreed upon with the FDA (NCT06020235 — ClinicalTrials.gov) comparing 2 different gel-concentrations (5% and 10%) each as either once-a-day or twice-a-day treatments in comparison to a placebo group. The study is fully blinded and primarily determines antimicrobial response and clinical infection improvement, in addition to relevant safety information and wound healing.

The Company recently decided to add a smaller Phase 2a study to the development program to establish a dose response curve in patients testing 3 different active treatments (2%, 5% and 10% gel). With all other relevant protocol components remaining identical to the Phase 2b study that has been discussed and agreed upon with the FDA, this study will allow easy transition from the Phase 2a to the Phase 2b study while at the same time providing important clinical feedback on the potential safety and efficacy of Nu-3.

Additional Indications

Beyond the lead indication of iDFU, we believe that essentially every infection of more superficial wounds could be in scope for Nu-3 gel as treatment. This includes wounds from injuries or burns as well as post-surgical wound infections. Another application for a solution formulation may be for otitis externa, which is frequently observed in children and young adults. All these additional applications would require the respective clinical testing and the subsequent review and approval process by the FDA and comparable regulatory authorities.

Lakewood-Amedex Biotherapeutics Inc. data.

CAUTI

Background

Complicated urinary tract infections and especially catheter-associated urinary tract infections (CAUTI) are frequently caused by drug resistant bacteria and bacterial biofilm³¹. The Bisphosphocin^® class has demonstrated in vitro activity against a broad range of resistant bacteria, including those frequently found in UTI, such as E. coli, K. pneumoniae, and P. aeruginosa, as well as having demonstrated activity against biofilm forming organisms. In addition, in vivo activity has been demonstrated in animal models of UTI. Compounds with a larger pH range for activity provide an opportunity to match different compounds to different indications, where the pH of the drug delivery formulation can be adjusted to suit the target organ. For example, the skin is more tolerant of lower pHs, whereas formulations designed for the bladder should be at a higher pH — typically > 3.5. Lakewood-Amedex Biotherapeutics Inc. is currently screening several new agents from the Bisphosphocin^® class with the goal of selecting the most promising and indication-appropriate candidate to progress into the clinic after the submission of an Investigative New Drug application (IND).

Non-clinical studies conducted as proof of concept utilizing infected rat bladders confirmed that the intravesical administration of Nu-8, as one of the potential compound candidates at a pH of 3.5, significantly reduced bladder colony-forming units (CFUs). Wistar female rats were infected with E. coli through a guided sterile catheter on day 0 and again on day 1. Four hours after the second infection, the rats received either a vehicle or a 5% or 10% Nu-8 solution for a duration of 30 minutes. Following the treatment, the urethral opening was sealed with true seal glue to ensure bladder retention, thereby simulating the clinical conditions of catheterized patients. The intravesical treatment with Nu-8 for 30 minutes demonstrated a notable antibacterial effect in the bladder at both 5% and 10% doses when compared to the vehicle control group (see Figure 12). A similar study using Nu-10 in the rat urinary tract infection model demonstrated a notable antibacterial effect in the bladder at both 2.5% and 5% doses when compared to the vehicle control group (see Figure 13). Throughout both of these studies, all animals appeared to be in normal health.³²

Öztürk R., Murt A., Epidemiology of urological infections: a global burden, World Journal of Urology, 2020, 38, 2669-2679

Lakewood-Amedex Biotherapeutics Inc. data.

Figure 12: The administration of Nu-8 via intravesical delivery for a period of 30 minutes exhibited a significant bactericidal effect against the urinary pathogen E. coli, demonstrating a concentration-dependent response in a rat model of urinary tract infection.

Figure 13: The administration of Nu-10 via intravesical delivery for a period of 30 minutes exhibited a significant bactericidal effect against the urinary pathogen E. coli, demonstrating a concentration-dependent response in a rat model of urinary tract infection.

Further non-clinical research with Nu-8, Nu-10, and Nu-11, and some other portfolio compounds, will be performed to identify the most suitable candidate to be advanced into early clinical development.

Pulmonary

Background

Pulmonary infections such as community acquired bronchial pneumonia (CABP), hospital acquired bronchial pneumonia (HABP), and ventilator acquired bronchial pneumonia (VABP) are frequently caused by drug resistant bacteria. In addition, patients with cystic fibrosis have recurrent bacterial and fungal lung infections with organisms such as P. aeruginosa and A. fumigatus. The Bisphosphocin^® class has demonstrated in vitro activity against a broad range of resistant bacteria, including those frequently found in pulmonary infections such as H. influenzae, K. pneumoniae, and P. aeruginosa. In addition, in vivo activity has been demonstrated in animal models of pulmonary infections caused by Acinetobacter species, P. aeruginosa, and A. fumigatus. Lakewood-Amedex Biotherapeutics Inc. is currently screening several new agents from the Bisphosphocin^® class with the goal of selecting a candidate to progress into the clinic after the submission of an IND.

In vivo animal data

The Bisphosphocin^® Nu-8 shows high activity in the treatment of lung infections caused by a range of organisms. Figure 14 shows three such experiments where the administration of a solution of Nu-8 as an aerosol dramatically reduces the microbial counts in the lung.³³

Figure 14a

Figure 14b

Lakewood-Amedex Biotherapeutics Inc. data.

Figure 14c

Figure 14: Murine Pneumonia models: a) Acinetobacter model; b) Aspergillus model, and c) Pseudomonas model. Neutropenic mice were infected intranasally with the indicated microorganism. Twenty-four hours post-infection, animals were treated intra-nasally by nebulization with Nu-8 (10% nebulized for twenty minutes, twice). At 2-, 4-, and 6-hours post-treatment, animals were terminated; lung tissues were collected to determine the bacterial load. Nu-8 (10%) showed significant antibacterial activity (p<0.05) at 2-, 4-, and 6-hours post-nebulization administration when compared to the vehicle control at 2- and 4-hours.

Intellectual Property

Lakewood-Amedex Biotherapeutic Inc.’s broad antimicrobial technology platform is well protected by an intellectual property portfolio. The broad patent estate comprises 104 patents, 68 of which have been allowed, with the remaining 36 being pending applications. The key patent filings provide protection through at least 2038, and the most recent patent applications will extend protection through 2044, once issued. Our patents cover compositions of matter of the Bisphosphocin^® class and other related classes of compounds; formulations of Nu-3; use patents for the Bisphosphocin^® class; and process patents for the class.

Trademarks

The Company has one registered trademark:

Mark

Filed

Serial No

Granted

Reg No

BISPHOSPHOCIN

12/5/2012

85/795,204

1/1/2014

4,468,925

Patents

The Company has 68 issued patents originally developed by the Company and 36 pending patents originally developed by the Company. The following table outlines each of the patents, both issued and pending, with the application number, the date filed, the patent number (if applicable), the title, status, anticipated expiration date, and portfolio compound(s) associated with the patent.

Country Name

Application #

Date Filed

Patent #

Title

Development
Compounds

Status

Anticipated
Expiration
Date

United States of America

16/006,660

6/12/2018

11096954

Bisphosphocin Gel Formulations And Uses Thereof

Nu-3

Issued

6/12/2038

Australia

2018230805

3/12/2018

2018230805

Antimicrobial Compounds, Compositions, And Uses Thereof

Nu-8, Nu-10, Nu-11

Issued

3/12/2038

Brazil

BR112019018615-8

3/12/2018

BR112019018615-8

Antimicrobial Compounds, Compositions, And Uses Thereof

Nu-8, Nu-10, Nu-11

Issued

3/12/2038

China

201880030624.4

3/12/2018

ZL201880030624.4

Antimicrobial Compounds, Compositions, And Uses Thereof

Nu-8, Nu-10, Nu-11

Issued

3/12/2038

European Patent Office

18763136.1

3/12/2018

3592430

Antimicrobial Compounds, Compositions, And Uses Thereof

Nu-8, Nu-10, Nu-11

Issued

3/12/2038

India

201927040425

3/12/2018

544145

Antimicrobial Compounds, Compositions, And Uses Thereof

Nu-8, Nu-10, Nu-11

Issued

3/12/2038

Japan

2019-570355

3/12/2018

6917078

Antimicrobial Compounds, Compositions, And Uses Thereof

Nu-8, Nu-10, Nu-11

Issued

3/12/2038

Mexico

MX/a/2019/010695

3/12/2018

391911

Antimicrobial Compounds, Compositions, And Uses Thereof

Nu-8, Nu-10, Nu-11

Issued

3/12/2038

New Zealand

757711

3/12/2018

757711

Antimicrobial Compounds, Compositions, And Uses Thereof

Nu-8, Nu-10, Nu-11

Issued

3/12/2038

Republic of Korea

10-2019-7029037

3/12/2018

10-2317158

Antimicrobial Compounds, Compositions, And Uses Thereof

Nu-8, Nu-10, Nu-11

Issued

3/12/1938

European Patent Office

18816615.1

6/12/2018

EP 3638251

Bisphosphocin Gel Formulations And Uses Thereof

Nu-3

Issued

6/12/2038

Country Name

Application #

Date Filed

Patent #

Title

Development
Compounds

Status

Anticipated
Expiration
Date

India

201927053712

6/12/2018

480187

Bisphosphocin Gel Formulations And Uses Thereof

Nu-3

Issued

6/12/2038

Japan

2019-567981

6/12/2018

7148994

Bisphosphocin Gel Formulations And Uses Thereof

Nu-3

Issued

6/12/2038

Hong Kong

62020007940.3

3/12/2018

HK40018480

Antimicrobial Compounds, Compositions, And Uses Thereof

Nu-8, Nu-10, Nu-11

Issued

3/12/2038

Hong Kong

62020015056.8

6/12/2018

HK40025987

Bisphosphocin Gel Formulations And Uses Thereof

Nu-3

Issued

6/12/2038

United States of America

16/505,497

7/8/2019

10752651

Antimicrobial Compounds, Compositions, And Uses Thereof

Nu-8, Nu-10, Nu-11

Issued

3/12/2038

United States of America

16/505,501

7/8/2019

10711028

Antimicrobial Compounds, Compositions, And Uses Thereof

Nu-8, Nu-10, Nu-11

Issued

3/12/2038

United States of America

16/941,627

7/29/2020

10981943

Antimicrobial Compounds, Compositions, And Uses Thereof

Nu-8, Nu-10, Nu-11

Issued

3/12/2038

Australia

2021201251

3/12/2018

20211201251

Antimicrobial Compounds, Compositions, And Uses Thereof

Nu-8, Nu-10, Nu-11

Issued

3/12/2038

United States of America

17/234,430

4/19/2021

11377468

Antimicrobial Compounds, Compositions, And Uses Thereof

Nu-8, Nu-10, Nu-11

Issued

3/12/2038

United States of America

17/396,989

8/9/2021

12156883

Bisphosphocin Gel Formulations And Uses Thereof

Nu-3

Issued

6/12/2038

Japan

2021-115155

3/12/2018

7315248

Antimicrobial Compounds, Compositions, And Uses Thereof

Nu-8, Nu-10, Nu-11

Issued

3/12/2038

Brazil

BR122021011439-0

6/12/2018

BR122021011439-0

Bisphosphocin Gel Formulations And Uses Thereof

Nu-3

Issued

6/12/2038

United States of America

17/856,537

7/1/2022

US 12,030,908

Antimicrobial Compounds, Compositions, And Uses Thereof

Nu-8, Nu-10, Nu-11

Issued

3/12/2038

Republic of Korea

10-2021-7031132

3/12/2018

10-2621577

Antimicrobial Compounds, Compositions, And Uses Thereof

Nu-8, Nu-10, Nu-11

Issued

3/12/2038

Hong Kong

42022051265.1

3/12/2018

HK40060969 B

Antimicrobial Compounds, Compositions, And Uses Thereof

Nu-8, Nu-10, Nu-11

Issued

3/12/2038

Country Name

Application #

Date Filed

Patent #

Title

Development
Compounds

Status

Anticipated
Expiration
Date

United States of America

17/890,102

8/17/2022

11795192

Antimicrobial Compounds, Compositions, And Uses Thereof

Nu-8, Nu-10, Nu-11

Issued

3/12/2038

Australia

2022224829

6/12/2018

2022224829

Bisphosphocin Gel Formulations And Uses Thereof

Nu-3

Issued

6/12/2038

Japan

2022-147051

6/12/2018

7470449

Bisphosphocin Gel Formulations And Uses Thereof

Nu-3

Issued

6/12/2038

Australia

2022256216

10/21/2022

2022256216

Antimicrobial Compounds, Compositions, And Uses Thereof

Nu-8, Nu-10, Nu-11

Issued

3/12/2038

Australia

2022256175

3/12/2018

2022256175

Antimicrobial Compounds, Compositions, And Uses Thereof

Nu-8, Nu-10, Nu-11

Issued

3/12/2038

New Zealand

793633

3/12/2018

Pending

Antimicrobial Compounds, Compositions, And Uses Thereof

Nu-8, Nu-10, Nu-11

Issued

3/12/2038

Republic of Korea

10-2022-7039954

3/12/2018

10-2684529

Antimicrobial Compounds, Compositions, And Uses Thereof

Nu-8, Nu-10, Nu-11

Issued

3/12/2038

New Zealand

798061

3/12/2018

Pending

Antimicrobial Compounds, Compositions, And Uses Thereof

Nu-8, Nu-10, Nu-11

Issued

3/12/2038

United States of America

18/457,288

12/14/2023

12054509

CIP claim development

Nu-8, Nu-10, Nu-11

Issued

3/12/2038

Austria

18816615.1

6/12/2018

EP 3638251

Bisphosphocin Gel Formulations And Uses Thereof

Nu-3

Issued

6/12/2038

Belgium

18816615.1

6/12/2018

EP 3638251

Bisphosphocin Gel Formulations And Uses Thereof

Nu-3

Issued

6/12/2038

Denmark

18816615.1

6/12/2018

EP 3638251

Bisphosphocin Gel Formulations And Uses Thereof

Nu-3

Issued

6/12/2038

Finland

18816615.1

6/12/2018

EP 3638251

Bisphosphocin Gel Formulations And Uses Thereof

Nu-3

Issued

6/12/2038

France

18816615.1

6/12/2018

EP 3638251

Bisphosphocin Gel Formulations And Uses Thereof

Nu-3

Issued

6/12/2038

Germany

18816615.1

6/12/2018

EP 3638251

Bisphosphocin Gel Formulations And Uses Thereof

Nu-3

Issued

6/12/2038

Country Name

Application #

Date Filed

Patent #

Title

Development
Compounds

Status

Anticipated
Expiration
Date

Greece

18816615.1

6/12/2018

EP 3638251

Bisphosphocin Gel Formulations And Uses Thereof

Nu-3

Issued

6/12/2038

Ireland

18816615.1

6/12/2018

EP 3638251

Bisphosphocin Gel Formulations And Uses Thereof

Nu-3

Issued

6/12/2038

Italy

18816615.1

6/12/2018

EP 3638251

Bisphosphocin Gel Formulations And Uses Thereof

Nu-3

Issued

6/12/2038

Netherlands

18816615.1

6/12/2018

EP 3638251

Bisphosphocin Gel Formulations And Uses Thereof

Nu-3

Issued

6/12/2038

Norway

18816615.1

6/12/2018

EP 3638251

Bisphosphocin Gel Formulations And Uses Thereof

Nu-3

Issued

6/12/2038

Portugal

18816615.1

6/12/2018

EP 3638251

Bisphosphocin Gel Formulations And Uses Thereof

Nu-3

Issued

6/12/2038

Spain

18816615.1

6/12/2018

EP 3638251

Bisphosphocin Gel Formulations And Uses Thereof

Nu-3

Issued

6/12/2038

Sweden

18816615.1

6/12/2018

EP 3638251

Bisphosphocin Gel Formulations And Uses Thereof

Nu-3

Issued

6/12/2038

Switzerland

18816615.1

6/12/2018

EP 3638251

Bisphosphocin Gel Formulations And Uses Thereof

Nu-3

Issued

6/12/2038

United Kingdom

18816615.1

6/12/2018

EP 3638251

Bisphosphocin Gel Formulations And Uses Thereof

Nu-3

Issued

6/12/2038

Austria

18763136.1

3/12/2018

EP 3592430

Antimicrobial Compounds, Compositions, And Uses Thereof

Nu-8, Nu-10, Nu-11

Issued

3/12/2038

Belgium

18763136.1

3/12/2018

EP 3592430

Antimicrobial Compounds, Compositions, And Uses Thereof

Nu-8, Nu-10, Nu-11

Issued

3/12/2038

Denmark

18763136.1

3/12/2018

EP 3592430

Antimicrobial Compounds, Compositions, And Uses Thereof

Nu-8, Nu-10, Nu-11

Issued

3/12/2038

Finland

18763136.1

3/12/2018

EP 3592430

Antimicrobial Compounds, Compositions, And Uses Thereof

Nu-8, Nu-10, Nu-11

Issued

3/12/2038

France

18763136.1

3/12/2018

EP 3592430

Antimicrobial Compounds, Compositions, And Uses Thereof

Nu-8, Nu-10, Nu-11

Issued

3/12/2038

Germany

18763136.1

3/12/2018

EP 3592430

Antimicrobial Compounds, Compositions, And Uses Thereof

Nu-8, Nu-10, Nu-11

Issued

3/12/2038

Country Name

Application #

Date Filed

Patent #

Title

Development
Compounds

Status

Anticipated
Expiration
Date

Greece

18763136.1

3/12/2018

EP 3592430

Antimicrobial Compounds, Compositions, And Uses Thereof

Nu-8, Nu-10, Nu-11

Issued

3/12/2038

Ireland

18763136.1

3/12/2018

EP 3592430

Antimicrobial Compounds, Compositions, And Uses Thereof

Nu-8, Nu-10, Nu-11

Issued

3/12/2038

Italy

18763136.1

3/12/2018

EP 3592430

Antimicrobial Compounds, Compositions, And Uses Thereof

Nu-8, Nu-10, Nu-11

Issued

3/12/2038

Netherlands

18763136.1

3/12/2018

EP 3592430

Antimicrobial Compounds, Compositions, And Uses Thereof

Nu-8, Nu-10, Nu-11

Issued

3/12/2038

Norway

18763136.1

3/12/2018

EP 3592430

Antimicrobial Compounds, Compositions, And Uses Thereof

Nu-8, Nu-10, Nu-11

Issued

3/12/2038

Portugal

18763136.1

3/12/2018

EP 3592430

Antimicrobial Compounds, Compositions, And Uses Thereof

Nu-8, Nu-10, Nu-11

Issued

3/12/2038

Spain

18763136.1

3/12/2018

EP 3592430

Antimicrobial Compounds, Compositions, And Uses Thereof

Nu-8, Nu-10, Nu-11

Issued

3/12/2038

Sweden

18763136.1

3/12/2018

EP 3592430

Antimicrobial Compounds, Compositions, And Uses Thereof

Nu-8, Nu-10, Nu-11

Issued

3/12/2038

Switzerland

18763136.1

3/12/2018

EP 3592430

Antimicrobial Compounds, Compositions, And Uses Thereof

Nu-8, Nu-10, Nu-11

Issued

3/12/2038

United Kingdom

18763136.1

3/12/2018

EP 3592430

Antimicrobial Compounds, Compositions, And Uses Thereof

Nu-8, Nu-10, Nu-11

Issued

3/12/2038

Republic of Korea

10-2024-7022774

3/12/2018

10-2772428

Antimicrobial Compounds, Compositions, And Uses Thereof

Nu-8, Nu-10, Nu-11

Issued

3/12/2038

Canada

3,055,932

3/12/2018

tbd

Antimicrobial Compounds, Compositions, And Uses Thereof

Nu-8, Nu-10, Nu-11

Pending

3/12/2038

China

201880038759.5

6/12/2018

tbd

Bisphosphocin Gel Formulations And Uses Thereof

Nu-3

Pending

6/12/2038

New Zealand

759577

6/12/2018

tbd

Bisphosphocin Gel Formulations And Uses Thereof

Nu-3

Pending

6/12/2038

Canada

3,066,722

6/12/2018

tbd

Bisphosphocin Gel Formulations And Uses Thereof

Nu-3

Pending

6/12/2038

Country Name

Application #

Date Filed

Patent #

Title

Development
Compounds

Status

Anticipated
Expiration
Date

United States of America

18/756,504

6/27/2024

tbd

Antimicrobial Compounds, Compositions, And Uses Thereof

Nu-3

Pending

3/12/2038

Mexico

MX/a/2022/015018

6/12/2018

tbd

Bisphosphocin Gel Formulations And Uses Thereof

Nu-3

Pending

6/12/2038

European Patent Office

23196359.6

3/12/2018

tbd

Antimicrobial Compounds, Compositions, And Uses Thereof

Nu-8, Nu-10, Nu-11

Pending

3/12/2038

Japan

2023-111463

3/12/2018

tbd

Antimicrobial Compounds, Compositions, And Uses Thereof

Nu-8, Nu-10, Nu-11

Pending

3/12/2038

Republic of Korea

10-2023-7004991

6/12/2018

tbd

Bisphosphocin Gel Formulations And Uses Thereof

Nu-3

Pending

6/12/2038

India

202328014315

6/12/2018

tbd

Bisphosphocin Gel Formulations And Uses Thereof

Nu-3

Pending

6/12/2038

European Patent Office

23156658.9

6/12/2018

tbd

Bisphosphocin Gel Formulations And Uses Thereof

Nu-3

Pending

6/12/2038

Canada

3,066,722

7/26/2023

tbd

Methods of Synthesis of Nu-3 and Nu-8

Nu-3 and Nu-8

Pending

7/26/2043

United States of America

18/540,055

12/14/2023

tbd

Antiviral compounds, compositions and uses thereof

Nu-8, Nu-10, Nu-11

Pending

12/14/2043

Australia

2023285791

3/12/2018

tbd

Antimicrobial Compounds, Compositions, And Uses Thereof

Nu-8, Nu-10, Nu-11

Pending

3/12/2038

United States of America

18/793,205

8/2/2024

tbd

Bisphosphocin Gel Formulations And Uses Thereof

Nu-3

Pending

3/12/2038

United States of America

PCT/US24/26526

4/26/2024

tbd

Substituted pyrimidone and azapyrimidones and methods of use thereof

None

Pending

TBD

United States of America

PCT/US24/26369

4/26/2024

tbd

Substituted pyrimidinedione compounds, compositions, and uses thereof

None

Pending

TBD

United States of America

PCT/US24/26372

4/26/2024

tbd

Substituted bicyclic heterocycle compounds, compositions, and uses thereof

None

Pending

TBD

Hong Kong

42024088148.2

6/12/2018

tbd

Bisphosphocin Gel Formulations And Uses Thereof

Nu-3

Pending

6/12/2038

India

202428022732

3/12/2018

tbd

Antimicrobial Compounds, Compositions, And Uses Thereof

Nu-8, Nu-10, Nu-11

Pending

3/12/2038

Country Name

Application #

Date Filed

Patent #

Title

Development
Compounds

Status

Anticipated
Expiration
Date

Australia

2024202211

6/12/2018

tbd

Bisphosphocin Gel Formulations And Uses Thereof

Nu-3

Pending

6/12/2038

United States of America

18/933,370

10/31/2024

tbd

Bisphosphocin Gel Formulations And Uses Thereof

Nu-3

Pending

10/31/2044

Republic of Korea

10-2025-7005507

3/12/2018

tbd

Antimicrobial Compounds, Compositions, And Uses Thereof

Nu-8, Nu-10, Nu-11

Pending

3/12/2038

PCT

PCT/US25/17096

2/24/2025

tbd

Nu-3 disodium salt

Nu-3

Pending

2/24/2044

United States of America

63/761,397

2/21/2025

tbd

Substituted tetrahydrofuran compounds, compositions, and uses thereof

None

Pending

2/21/2046

United States of America

63/761,404

2/21/2025

tbd

Substituted tetrahydrofuran compounds, compositions, and uses thereof

None

Pending

2/21/2046

United States of America

63/761,409

2/21/2025

tbd

Phosphorylated heterocyclic molecules with carbon-nitrogen bonds

None

Pending

2/21/2046

United States of America

63/761,411

2/21/2025

tbd

Phosphorylated heterocyclic molecules with carbon-oxygen bonds

None

Pending

2/21/2046

United States of America

19/478,698

4/26/24

Tbd

Substituted
pyrimidinone and azapyrimidinone compounds, compositions, and uses thereof

None

Pending

4/26/2043

European Patent Office

24798058.4

4/26/2024

Tbd

Substituted
pyrimidinone and azapyrimidinone compounds, compositions, and uses thereof

None

Pending

4/26/2043

Japan

2025-562787

4/26/2024

Tbd

Substituted
pyrimidinone and azapyrimidinone compounds, compositions, and uses thereof

None

Pending

4/26/2043

China

202480041541.0

4/26/2024

Tbd

Substituted
pyrimidinone and azapyrimidinone compounds, compositions, and uses thereof

None

Pending

4/26/2043

United States of America

19/478,658

4/26/2024

tbd

Substituted pyrimidinedione compounds, compositions, and uses thereof

None

Pending

4/26/2043

Country Name

Application #

Date Filed

Patent #

Title

Development
Compounds

Status

Anticipated
Expiration
Date

United States of America

19/478,661

4/26/2024

Tbd

Substituted bicyclic heterocycle compounds, compositions, and uses thereof

None

Pending

4/26/2043

European Patent Office

24797997.4

4/26/2024

Tbd

Substituted bicyclic heterocycle compounds, compositions, and uses thereof

None

Pending

4/26/2043

Japan

2025-167137

3/12/2018

Tbd

Antimicrobial compounds, compositions, and uses thereof

Nu-8, Nu-10, Nu-11

Pending

3/12/2038

Competitive Positioning

In our assessment of the competitive landscape for our lead compound, Nu-3, in the treatment of mildly infected diabetic foot ulcers (iDFU), we focus on infection control as a critical component within the overall treatment of iDFU. Many regulated products, most of which are devices, are available to facilitate wound healing. However, we believe that none of them have demonstrated sufficient antimicrobial properties or the ability to tackle resistant pathogens. There is a general consensus that wound healing cannot occur in the presence of active infection. Therefore, the first step in treatment must be infection control, including addressing biofilm. Currently, there are limited treatment options available for this phase of the disease. These can be divided into:

The current standard of care, which includes treatment with an oral antibiotic.

Over-the-counter (OTC) topicals.

Two topical agents are currently in development, with limited public information and a partially different therapeutic focus from iDFU.

The Standard of Care (SOC) treatment consists of wound cleaning (including light debridement), protective measures (wound coverage and pressure reduction), and antibiotic therapy. However, there is no published proof, or even strong evidence, that oral antibiotic therapy adds measurable and reliable benefit beyond basic wound cleaning measures in controlling infection. Diabetic skin lesions on the foot are primarily caused by peripheral microvascular disease, which severely impairs the perfusion of superficial skin and tissue layers. This raises significant doubt about whether oral antibiotics can reach sufficient concentrations at the site of infection. Additionally, treatment guidelines cite the evidence for oral antibiotic use in this setting as limited, if any.

For these reasons, a locally delivered topical treatment that is independent of vascular perfusion represents a missing link in current treatment regimens for patients with mild iDFU, and Nu-3 is designed to fill that gap. Its ability to reliably eliminate resistant pathogens and biofilm means it could be used as a first-line treatment, even before lab culture results are available. Nu-3 has the potential to become the new standard of care. The primary competitive challenge lies in changing existing treatment habits. Addressing this will require early and active involvement of key opinion leaders in clinical trials, engagement with guideline authors to support Nu-3’s inclusion in treatment guidelines, and a strong stream of pre-market scientific communications.

Available OTC topicals are widely used but lack proof of efficacy in the iDFU setting. They are not effective against biofilm, nor are they effective against resistant pathogens. Current use of OTC topicals is limited among treating podiatrists, though further market research is needed. From today’s perspective, OTC topicals do not seem to pose a major competitive challenge.

Growth Strategies

Lakewood-Amedex Biotherapeutic Inc.’s growth strategies include the expansion of indications for its lead product in the treatment of acute bacterial skin and skin structure infections (ABSSSI), as well as the pursuit of additional indications that are amenable to local application. The Company also plans to expand its structure-activity relationship (SAR) efforts to discover new chemical entities with greater potency.

Industry Overview and Opportunity

ID and DFU Market Overview

There is an urgent need for new classes of antibiotics to break the cycle of resistance development and to address the antimicrobial resistance crisis. However, the development of new antibiotics has slowed, with most advancements in recent years occurring within existing drug classes, leaving them vulnerable to resistance mechanisms. These newer drugs are therefore likely to be only temporary solutions. In the last five years (2020 – 2024), there have been 13 new FDA drug approvals for infectious diseases — five antibiotics, two antivirals, three live biotherapeutics, and three antifungals (see Table 4). Ten of the approvals are for small molecules, and all are from established classes of antimicrobials.

Table 4: Antimicrobial FDA drug approvals since 2020

Trade Name	INN name	Approval Date	Type	Indication	Company
Blujepa	Gepotidacin	2025_03	Antibiotic	Uncomplicated UTI	GlaxoSmithKline
Orlynvah	Sulopenem/sulopenem etzadroxil-probenecid	2024_10	Antibiotic	Uncomplicated UTI	Iterum Therapeutics PLC
Exblifep	cefepime + enmetazobactam	2024_02	Antibiotic	Complicated UTI	Allecra Therapeutics GmbH
Voquenza	Vonoprazan, amoxicillin, clarithromycin	2023_11	Antibiotic	H. pylori infection	Phathom
Xacduro	Sulbactam + durlobactam	2023_05	Antibiotic	HABP/VABP	Innovia
Paxlovid	Nirmatrevir, ritonavir	2023_05	Antiviral	Mild to moderate COVID	Pfizer
VOWST	SER-109	2023_04	Live biotherapeutic	Recurrent diarrhea prevention	Seres Therapeutics
Rezzayo	Rezafungin	2023_03	Antifungal	Candidemia and invasive candidiasis	Patheon
Sunleca	Lenacapvir	2022_12	Antiviral	Multidrug-resistant HIV infection	Gilead
Biomictra	BB128	2022_11	Live biotherapeutic	Recurrent diarrhea prevention	Biomebank
Reboyta	RBX2660	2022_11	Live biotherapeutic	Recurrent diarrhea prevention	Ferring Pharmaceuticals
Vivjoa	Otesconazole	2022_04	Antifungal	Vulvovaginal candidiasis	Mycovia
Brexafemme	Ibrexafungerp	2021_06	Antifungal	Vulvovaginal candidiasis	Merck

There are many antibacterial agents in development, and the development status and expected therapeutic targets of the compounds currently in development are summarized in Table 5.³⁴ Approximately 75% of the compounds are from known classes of agents and are therefore susceptible to the development of resistance via established resistance mechanisms. Many agents are being developed for multiple indications, with approximately 25% being developed for acute bacterial skin and skin structure infections (ABSSSI), 20% for urinary tract infections, and 28% for pulmonary infections. In addition, most compounds are targeted for systemic treatment through the oral or intravenous route, with only 3 of the 49 known compounds in development being advanced as topical agents — Recce 327, Pravibismane, and Finafloxacin. Of the three topical agents in development, only two have novel mechanisms of action, which have the potential to avoid resistance, and two are targeted at infections in diabetic foot ulcers. Accordingly, the Lakewood-Amedex Biotherapeutics Inc. Bisphosphocin^®compounds occupy a unique segment of the existing drugs in development and represent a highly differentiated class of agents with a novel mechanism of action and a low potential for resistance development. The local drug delivery at high concentration of a very potent antimicrobial drug represents a novel and relevant targeted approach, especially in conditions like iDFU, in which the use of systemic antibiotics is of questionable value because of the poor perfusion in the infected wound area. In addition, the local application helps avoid the typical side effects of systemic antibiotics.

Adapted and extended from “2023 Antibacterial agents in clinical and preclinical development: an overview and analysis, WHO, ISBN 978-92-4-009400-0.

Table 5: Summary of antibacterial compounds currently in development

Development Phase	Total No		Novel MOA		Established MOA		Topical Agent		Skin/Wound		UTI		Pulmonary
Phase 1		21		3		18		0		2		3		5
Phase 1/2		2		2		0		1		1		1		1
Phase 2		15		5		10		2		6		2		4
Phase 3		11		3		8		0		3		4		4
Totals		49		13		36		3		12		10		14

The two topical treatments targeting the treatment of infections in DFU are Recce 327 and Pravibismane. Recce 327 is being developed by an Australian company, Recce, and the compound demonstrates efficacy against resistant pathogens, with the focus on septic conditions and intravenous applications. In addition, the company is testing a gel formulation in a wound infection population, which also includes patients with iDFU. No fully published studies on existing clinical studies are publicly available, although the company reports the start of a phase 3 study in Indonesia. The details are not available and are not posted on the Australian clinical trial database nor on ClinicalTrials.gov. Pravibismane is being developed by the Microbion Corporation for several target indications with different formulations. One of the indications includes moderately and severely infected DFUs. The only available data published is a post-hoc analysis of a small study that was completed in 2019, which discloses a reduction in wound size. However, no results on infection control and microbiological response are reported, and the data only provide a pooled outcome measure. It is unclear if a sufficient antimicrobial effect exists.

Regulatory Background

In the United States, the FDA regulates pharmaceutical products under the Federal Food, Drug, and Cosmetic Act, or the FDCA, the PHSA, and regulations and guidance documents implementing these laws. The FDCA, PHSA, and their corresponding regulations govern, among other things, the testing, manufacturing, safety, purity, potency, labeling, packaging, storage, record keeping, distribution, reporting, advertising, and other promotional practices involving pharmaceutical products. Consent from the FDA is required before conducting human clinical testing of drug products. FDA approval of a new drug application (NDA) must also be obtained before marketing a new drug. The process of obtaining regulatory approvals and the subsequent compliance with appropriate federal, state, local, and foreign statutes and regulations requires the continued expenditure of substantial time and financial resources.

U.S. Small Molecule New Drug Product Development Process

Any new drug product must be approved by the FDA before it may be legally marketed in the United States. FDA approval is also required before marketing an approved drug product for a new indication or condition of use. The process required by the FDA before a new drug product candidate may be marketed in the United States generally involves the following:

●

Completion of preclinical laboratory tests and in vivo studies in accordance with the FDA’s Good Laboratory Practice (GLP) regulations and applicable requirements for the humane use of laboratory animals or other applicable regulations;

●

Submission to the FDA of an investigational new drug (IND) application, which allows human clinical trials to begin unless the FDA objects (issues a “clinical hold”) within 30 calendar days;

●

Approval by an independent institutional review board (IRB), reviewing each proposed clinical trial and clinical site before each clinical trial may be initiated;

●

Performance of adequate and well-controlled human clinical trials in accordance with the protocol contained in the approved IND and in accordance with the FDA’s Good Clinical Practice (GCP) regulations, and any additional requirements for the protection of human research subjects and their health information, to establish the safety and efficacy of the proposed product candidate for its intended use;

●

Preparation and submission to the FDA of a new drug application (NDA) for marketing approval that includes substantial evidence of safety and efficacy from results of nonclinical testing and clinical trials;

●

Review of the product by an FDA advisory committee, if applicable;

●

Satisfactory completion of an FDA inspection of the manufacturing facility or facilities where the product candidate is produced to assess compliance with current Good Manufacturing Practice (cGMP) requirements and to assure that the facilities, methods, and controls are adequate to preserve the product candidate’s identity, safety, strength, quality, potency, and purity;

●

Potential FDA audit of the nonclinical and clinical trial sites that generated the data in support of the NDA; and

●

Payment of user fees and FDA review and approval of the NDA.

The testing and approval process of product candidates requires substantial time, effort, and financial resources. Satisfaction of the FDA’s pre-market approval requirements typically takes many years, and the actual time required may vary substantially based upon the type, complexity, and novelty of the product or disease. Before testing any product candidate in humans, the product candidate must undergo preclinical testing. Preclinical tests, also referred to as nonclinical studies, include laboratory evaluations of product chemistry, toxicity, and formulation, as well as in vivo animal studies to assess the potential safety and activity of the product candidate and to establish a rationale for therapeutic use. The conduct of the preclinical tests must comply with federal regulations and requirements, including GLPs.

Concurrently with clinical trials, companies usually must complete some long-term preclinical testing, such as animal tests of reproductive adverse events and carcinogenicity, and must also develop additional information about the chemistry and physical characteristics of the drug and finalize a process for manufacturing the drug in commercial quantities in accordance with cGMP requirements. The manufacturing process must be capable of consistently producing quality batches of the product candidate, and, among other things, the manufacturer must develop methods for testing the identity, strength, quality, and purity of the final drug product. Additionally, appropriate packaging must be selected and tested, and stability studies must be conducted to demonstrate that the product candidate does not undergo unacceptable deterioration over its shelf life.

A clinical trial sponsor must submit the results of the preclinical tests, together with manufacturing information, analytical data, any available clinical data or literature, and a proposed clinical protocol, to the FDA as part of the IND. Some preclinical testing may continue even after the IND is submitted. The IND automatically becomes active 30 calendar days after receipt by the FDA, unless before that time the FDA raises concerns or questions related to a proposed clinical trial, including concerns that human research subjects will be exposed to unreasonable health risks, and places the clinical trial on a clinical hold. In such a case, the IND sponsor and the FDA must resolve any outstanding concerns before the clinical trial can begin. The FDA also may impose partial or full clinical holds on a product candidate at any time before or during clinical trials due to safety concerns or non-compliance. If the FDA imposes a clinical hold, trials may not begin or recommence without FDA authorization and then only under the terms authorized by the FDA. Accordingly, we cannot be sure that submission of an IND will result in the FDA allowing clinical trials to begin, or that, once they have begun, those issues will arise that partially or fully suspend or terminate such studies.

Human Clinical Trials Under an IND

Clinical trials involve the administration of the investigational product to healthy volunteers or patients under the supervision of qualified investigators, who generally are physicians not employed by, or under, the control of the trial sponsor. Clinical trials must be conducted under written study protocols detailing, among other things, the objectives of the trial, subject selection and exclusion, the trial procedures, the parameters to be used in monitoring safety, the criteria to be evaluated, and a statistical analysis plan. Each protocol and any amendments to the protocol must be submitted to the FDA as part of the IND.

Further, clinical trials must be conducted in accordance with federal regulations and GCP requirements, which include the requirements that all research subjects provide their informed consent in writing for their participation in any clinical trial, as well as review and approval by an IRB at each study site participating in the clinical trial or a central IRB. An IRB is charged with protecting the welfare and rights of trial participants and considers items such as whether the risks to individuals participating in the clinical trials are minimized and are reasonable in relation to anticipated benefits. The IRB also approves the form and content of the informed consent that must be signed by each clinical trial subject, or their legal representative, reviews and approves the study protocol, and must monitor the clinical trial until completion.

Human clinical trials typically are conducted in three sequential phases that may overlap or be combined:

●

Phase I. The product candidate is initially introduced into a small number of healthy human subjects and tested for safety, dosage tolerance, absorption, metabolism, distribution, excretion, and, if possible, to gain an early understanding of its value in treating patients. In the case of some product candidates for severe or life-threatening diseases, especially when the product candidate may be too inherently toxic to ethically administer to healthy volunteers, the initial human testing is often conducted in patients.

●

Phase II. The product candidate is evaluated in a limited patient population to identify possible adverse effects and safety risks, to preliminarily evaluate the efficacy of the product candidate for specific targeted diseases, and to determine dosage tolerance, optimal dosage, and dosing schedule.

●

Phase III. Phase III clinical trials are commonly referred to as “pivotal” or “registrational” studies, which typically denote a study that presents the data that the FDA or other relevant regulatory agency will use to determine whether or not to approve a product. In Phase III studies, the product candidate is administered to an expanded patient population, generally at multiple geographically dispersed clinical trial sites, in adequate and well-controlled clinical trials to generate sufficient data to statistically demonstrate the efficacy and safety of the product for approval. These clinical trials are intended to establish the overall risk/benefit ratio of the product candidate and provide an adequate basis for product labeling.

Post-approval clinical trials, sometimes referred to as Phase IV clinical trials, may be required by the FDA or may be voluntarily conducted after initial approval. These clinical trials are used to gain additional experience from the treatment of patients in the intended therapeutic indication, particularly for long-term safety follow-up.

During all phases of clinical development, regulatory agencies require extensive monitoring and auditing of all clinical activities, clinical data, and clinical trial investigators. Annual progress reports detailing the results of the clinical trials must be submitted to the FDA.

Written IND safety reports must be promptly submitted to the FDA and the investigators for: serious and unexpected adverse events; any findings from other studies, in vivo laboratory tests, or in vitro testing that suggest a significant risk for human subjects; or any clinically important increase in the rate of a serious suspected adverse reaction over that listed in the protocol or investigator brochure. The sponsor must submit an IND safety report within 15 calendar days after the sponsor determines that the information qualifies for reporting. The sponsor also must notify the FDA of any unexpected fatal or life-threatening suspected adverse reaction within seven calendar days after the sponsor’s initial receipt of the information. Relevant additional information obtained by the sponsor that pertains to a previously submitted IND safety report must be submitted as a follow-up IND safety report. Such a report should be submitted within 15 calendar days after the sponsor receives the information.

Information about certain clinical trials, including a description of the study and, in some cases, study results, must be submitted within specific timeframes to the National Institutes of Health (NIH), for public dissemination on their clinicaltrials.gov website. Manufacturers or distributors of investigational products for the diagnosis, monitoring, or treatment of one or more serious or life-threatening diseases or conditions where no other comparable or satisfactory therapeutic options exist must also have a publicly available policy on evaluating and responding to requests for expanded access, sometimes called “compassionate use,” requests.

Additionally, some clinical trials are overseen by an independent group of qualified experts organized by the clinical trial sponsor that regularly reviews accumulated data and advises the study sponsor regarding the continuing safety of the trial. This group, known as a Data and Safety Monitoring Board (DSMB) or Data and Safety Monitoring Committee (DSMC), may also review interim data to assess the continuing validity and scientific merit of the clinical trial. This group receives special access to unblinded data during the clinical trial and may advise the sponsor to halt the clinical trial if it determines there is an unacceptable safety risk for subjects or on other grounds, such as no demonstration of efficacy.

The FDA may order the temporary or permanent discontinuation of a clinical trial at any time or impose other sanctions if it believes that the clinical trial is not being conducted in accordance with FDA requirements or presents an unacceptable risk to the clinical trial patients. An IRB may also require the clinical trial at the site to be halted, either temporarily or permanently, for failure to comply with the IRB’s requirements or if the trial poses an unexpected serious harm to subjects. The FDA or an IRB may also impose conditions on the conduct of a clinical trial. Clinical trial sponsors may also choose to discontinue clinical trials as a result of risks to subjects, a lack of favorable results, or changing business priorities.

Compliance with Current Good Manufacturing Practices (cGMP)

Requirements: Manufacturers of pharmaceutical products must comply with applicable cGMP regulations, including quality control and quality assurance, and maintenance of records and documentation. Manufacturers and others involved in the manufacture and distribution of such products also must register their establishments with the FDA and certain state agencies. Both domestic and foreign manufacturing establishments must register and provide additional information to the FDA upon their initial participation in the manufacturing process. Establishments may be subject to periodic, unannounced inspections by government authorities to ensure compliance with cGMP requirements and other laws. Discovery of problems may result in a government entity placing restrictions on a product, manufacturer, or holder of an approved NDA, and may extend to requiring withdrawal of the product from the market. The FDA will not approve an NDA unless it determines that the manufacturing processes and facilities are in compliance with cGMP requirements and adequate to assure consistent production of the product within required specifications.

Concurrent with clinical trials, companies usually complete additional preclinical studies and must also develop additional information about the physical characteristics of the product candidate, as well as finalize a process for manufacturing the product candidate in commercial quantities in accordance with cGMP requirements. To help reduce the risk of the introduction of adventitious agents or of causing other adverse events with the use of small molecule products, the PHSA emphasizes the importance of manufacturing control for products whose attributes cannot be precisely defined. The manufacturing process must be capable of consistently producing quality batches of the product candidate, and, among other requirements, the sponsor must develop methods for testing the identity, strength, quality, potency, and purity of the final product. Additionally, appropriate packaging must be selected and tested, and stability studies must be conducted to demonstrate that the product candidate does not undergo unacceptable deterioration over its shelf life.

In relation to the clinical trials that may be conducted in other countries with a view to obtaining a marketing authorization, there are comparable cGMP requirements and other regulatory rules that are implemented nationally.

U.S. FDA Review and Approval Process

Assuming successful completion of the required clinical and preclinical testing, the results of the preclinical tests and clinical trials together with detailed information relating to the product’s CMC, including negative or ambiguous results as well as positive findings, and proposed labeling, among other things, are submitted to the FDA for NDA (new drug application) approval to market the product for one or more indications.

Under the Prescription Drug User Fee Act (PDUFA), as amended, each NDA must be accompanied by a significant user fee. The FDA adjusts the PDUFA user fees on an annual basis. The PDUFA also imposes an annual program fee for approved therapeutic products. Fee waivers or reductions are available in certain circumstances, including a waiver of the application fee for the first application filed by a small business. Additionally, no user fees are assessed on NDAs for product candidates designated as orphan drugs, unless the product candidate also includes a non-orphan indication.

In addition, under the Pediatric Research Equity Act (PREA), an NDA for a new active ingredient, indication, dosage form, dosage regimen, or route of administration, must contain data that are adequate to assess the safety and potential of the product for the claimed indications in all relevant pediatric subpopulations, and to support dosing and administration for each pediatric subpopulation for which the product is safe. Also, applications for product candidates intended for the treatment of adult cancer which are directed at molecular targets that the FDA determines to be substantially relevant to the growth or progression of pediatric cancer, in place of the PREA investigations, sponsors must submit, with the application, reports from molecularly targeted pediatric cancer investigations designed to yield clinically meaningful pediatric study data, using appropriate formulations, to inform potential pediatric labeling. The FDA may, on its own initiative or at the request of the applicant, grant deferrals for submission of some or all pediatric data until after approval of the product for use in adults, or full or partial waivers from the pediatric data requirements. Orphan products are also exempt from the PREA requirements.

The FDA reviews an NDA within 60 days of submission to determine if it is substantially complete before the agency accepts it for filing. The FDA may refuse to file any NDA that it deems incomplete or not properly reviewable at the time of submission and may request additional information. In that event, the NDA must be resubmitted with the additional information. The resubmitted application is also subject to review before the FDA accepts it for filing. Once the submission is accepted for filing, the FDA begins an in-depth, substantive review of the NDA.

The FDA reviews the NDA to determine, among other things, whether the proposed product candidate is safe and effective for its intended use, has an acceptable purity profile, and whether the product candidate is being manufactured in accordance with cGMP to assure and preserve the product candidate’s identity, safety, strength, quality, potency, and purity. The FDA may refer applications for novel therapeutic products or therapeutic products that present difficult questions of safety or efficacy to an advisory committee, typically a panel that includes clinicians and other experts, for review, evaluation, and a recommendation as to whether the application should be approved and under what conditions. The FDA is not bound by the recommendations of an advisory committee, but it considers such recommendations carefully when making decisions. During the product approval process, the FDA will also determine whether a risk evaluation and mitigation strategy (REMS) is necessary to ensure the safe use of the product candidate. REMS use risk minimization strategies beyond the professional labeling to ensure that the benefits of the product outweigh the potential risks. To determine whether a REMS is needed, the FDA will consider the size of the population likely to use the product, the seriousness of the disease, the expected benefit of the product, the expected duration of treatment, the seriousness of known or potential adverse events, and whether the product is a new molecular entity. A REMS could include medication guides, physician communication plans, and elements to assure safe use, such as restricted distribution methods, patient registries, and other risk minimization tools. If the FDA concludes a REMS is needed, the sponsor of the NDA must submit a proposed REMS; the FDA will not approve the NDA without a REMS if required.

Before approving an NDA, the FDA will inspect the facilities at which the product candidate is manufactured. The FDA will not approve the product candidate if it determines that the manufacturing processes and facilities are not in compliance with cGMP requirements or otherwise are not adequate to assure consistent production of the product candidate within required specifications. Additionally, before approving an NDA, the FDA typically will inspect one or more clinical sites to ensure that the clinical trials were conducted in compliance with IND trial requirements and GCP requirements.

On the basis of the NDA and accompanying information, including the results of the inspection of the manufacturing facilities, the FDA may issue an approval letter or a complete response letter. An approval letter authorizes commercial marketing of the product with specific prescribing information for specific indications. A complete response letter generally outlines the deficiencies in the submission and may require substantial additional testing or information in order for the FDA to reconsider the application. If and when those deficiencies have been addressed to the FDA’s satisfaction in a resubmission of the NDA, the FDA will issue an approval letter.

If a product candidate receives regulatory approval, the approval may be significantly limited to specific diseases and dosages, or the indications for use may otherwise be limited. Further, the FDA may require that certain contraindications, warnings, or precautions be included in the product labeling. The FDA may impose restrictions and conditions on product distribution, prescribing, or dispensing in the form of a REMS, or otherwise limit the scope of any approval. The FDA may also require post-marketing clinical trials, sometimes referred to as Phase IV clinical trials, designed to further assess a product’s safety, and testing and surveillance programs to monitor the safety of approved products that have been commercialized.

Every five years, the FDA agrees to specified performance goals in the review of NDAs under the PDUFA. One such current goal is to review standard NDAs in ten months after the FDA accepts the NDA for filing, and priority NDAs in six months, whereupon a review decision is to be made. The FDA does not always meet its PDUFA goal dates for standard and priority NDAs, and its review goals are subject to change from time to time. The review process and the PDUFA goal date may be extended by three months if the FDA requests or the NDA sponsor otherwise provides additional information or clarification regarding information already provided in the submission within the last three months before the PDUFA goal date.

Expedited Development and Review Programs

The FDA has a Fast Track program that is intended to expedite or facilitate the process for reviewing new drugs and biologics that meet certain criteria. Specifically, new drugs and biologics are eligible for Fast Track designation if they are intended to treat a serious or life-threatening condition and preclinical or clinical data demonstrate the potential to address unmet medical needs for the condition. Fast Track designation applies to both the product and the specific indication for which it is being studied. The sponsor can request the FDA to designate the product for Fast Track status any time before receiving NDA approval, but ideally no later than the pre-NDA or pre-BLA meeting.

Any product submitted to the FDA for marketing, including under a Fast Track program, may be eligible for other types of FDA programs intended to expedite development and review, such as priority review and accelerated approval. A product may be eligible for priority review if it is intended to treat a serious or life-threatening condition and, if approved, would provide a significant improvement in safety and effectiveness compared to available therapies.

A Fast Track product may also be eligible for rolling review, where the FDA may consider for review sections of the NDA on a rolling basis before the complete application is submitted, if the sponsor provides a schedule for the submission of the sections of the NDA, the FDA agrees to accept sections of the NDA and determines that the schedule is acceptable, and the sponsor pays any required user fees upon submission of the first section of the NDA.

A product may also be eligible for accelerated approval if it is intended to treat a serious or life-threatening condition and generally provides a meaningful advantage over available therapies. In addition, it must demonstrate an effect on a surrogate endpoint that is reasonably likely to predict clinical benefit or on a clinical endpoint that can be measured earlier than irreversible morbidity or mortality (IMM), which is reasonably likely to predict an effect on IMM or other clinical benefit. As a condition of approval, the FDA may require that a sponsor of a drug receiving accelerated approval perform adequate and well-controlled post-marketing clinical trials. If the FDA concludes that a drug shown to be effective can be safely used only if distribution or use is restricted, it may require such post-marketing restrictions as it deems necessary to assure safe use of the product.

Additionally, a drug may be eligible for designation as a Breakthrough Therapy if the product is intended, alone or in combination with one or more other drugs or biologics, to treat a serious or life-threatening condition and preliminary clinical evidence indicates that the product may demonstrate substantial improvement over currently approved therapies on one or more clinically significant endpoints. The benefits of the Breakthrough Therapy designation include the same benefits as the Fast Track designation, plus intensive guidance from the FDA to ensure an efficient drug development program. Fast Track designation, priority review, accelerated approval, and Breakthrough Therapy designation do not change the standards for approval but may expedite the development or approval process.

Post-Approval Requirements

After approval, there are also continuing annual program user fee requirements for approved products, excluding, under certain circumstances, orphan products.

Rigorous and extensive FDA regulation of pharmaceutical products continues after approval, particularly with respect to cGMP requirements. Manufacturers are required to comply with applicable requirements in the cGMP regulations, including quality control and quality assurance, and maintenance of records and documentation. To help reduce the increased risk of the introduction of adventitious agents, the PHSA emphasizes the importance of manufacturing controls for products whose attributes cannot be precisely defined. The PHSA also provides authority to the FDA to immediately suspend licenses in situations where there exists a danger to public health, to prepare or procure products in the event of shortages and critical public health needs, and to authorize the creation and enforcement of regulations to prevent the introduction or spread of communicable diseases in the United States and between states.

Other post-approval requirements applicable to pharmaceutical products include reporting of cGMP deviations that may affect the identity, potency, purity, and overall safety of a distributed product, record-keeping requirements, reporting of adverse effects, reporting updated safety and efficacy information, and complying with electronic record and signature requirements. In addition, the FDA conducts laboratory research related to the regulatory standards on the safety, purity, and potency of pharmacological products.

In addition, manufacturers and other entities involved in the manufacture and distribution of approved pharmaceuticals are required to register their establishments with the FDA and certain state agencies, list their products, and are subject to periodic announced and unannounced inspections by the FDA and these state agencies for compliance with current cGMP and other requirements, which impose certain procedural and documentation requirements upon us and third-party manufacturers. Manufacturers must continue to expend time, money, and effort in the areas of production and quality control to maintain compliance with current cGMPs. Regulatory authorities may withdraw product approvals or request product recalls if a company fails to comply with regulatory standards, if it encounters problems following initial marketing, or if previously unrecognized problems are subsequently discovered. In addition, changes to the manufacturing process or facility generally require prior FDA approval or notification before being implemented, and other types of changes to the approved product, such as adding new indications and additional labeling claims, are also subject to further FDA review and approval.

Moreover, the Drug Quality and Security Act imposes obligations on manufacturers of pharmaceutical products related to product tracking and tracing.

Adverse event reporting and submission of periodic reports, including annual reports and deviation reports, are required following FDA approval of an NDA. Later discovery of previously unknown problems with a product, including adverse events of unanticipated severity or frequency, or with manufacturing processes, or failure to comply with regulatory requirements, may result in significant regulatory actions. Such actions may include refusal to approve pending applications, license suspension or revocation, imposition of a partial or full clinical hold or termination of clinical trials, warning letters, untitled letters, modification of promotional materials or labeling, provision of corrective information, imposition of post-market requirements including the need for additional testing, imposition of distribution or other restrictions under a REMS, product recalls, product seizures or detentions, refusal to allow imports or exports, total or partial suspension of production or distribution, FDA debarment, injunctions, fines, consent decrees, corporate integrity agreements, suspension and debarment from government contracts, and refusal of orders under existing government contracts, exclusion from participation in federal and state healthcare programs, restitution, disgorgement, or civil or criminal penalties, including fines and imprisonment, and result in adverse publicity, among other adverse consequences.

A sponsor also must comply with the FDA’s advertising and promotion requirements, such as the prohibition on promoting products for uses or in patient populations that are inconsistent with the product’s approved labeling (known as “off-label use”). The FDA and other agencies actively enforce the laws and regulations prohibiting the promotion of off-label uses, and a company that is found to have improperly promoted off-label uses may be subject to significant liability. Violations relating to the promotion of off-label uses may lead to investigations alleging violations of federal and state healthcare fraud and abuse and other laws, as well as state consumer protection laws. Companies, however, may generally share truthful and non-misleading information that is otherwise consistent with a product’s FDA-approved labeling. Discovery of previously unknown problems or the failure to comply with the applicable regulatory requirements may result in restrictions on the marketing of a product or withdrawal of the product from the market, as well as possible civil or criminal sanctions.

Failure to comply with the applicable U.S. requirements at any time during the product development process, approval process, or after approval may subject an applicant or manufacturer to administrative or judicial civil or criminal actions and adverse publicity. These actions could include refusal to approve pending applications or supplemental applications, withdrawal of an approval, clinical hold, suspension or termination of a clinical trial by an IRB, warning or untitled letters, product recalls, product seizures, total or partial suspension of production or distribution, injunctions, fines or other monetary penalties, refusals of government contracts, mandated corrective advertising or communications with healthcare providers, debarment, restitution, disgorgement of profits or other civil or criminal penalties.

Broadly equivalent requirements and controls typically apply in other countries to the submission of marketing authorization applications and, post-approval, to the holding of such marketing authorizations.

The Hatch-Waxman Amendments and Generic Competition

Orange Book Listing

Once a drug product is approved under an NDA, the product is listed in the FDA’s publication, “Approved Drug Products with Therapeutic Equivalence Evaluations,” commonly known as the Orange Book. An NDA-approved drug product will be designated in the Orange Book as a Reference Listed Drug (RLD). Sponsors of approved NDAs are required to list with the FDA patents whose claims cover the product’s active ingredient, formulation, or an approved method of using the drug.

Patent Term Extensions

Depending upon the timing, duration, and specifics of FDA approval of the use of our therapeutic candidates, some of our United States patents may be eligible for limited patent term extension under the Hatch-Waxman Amendments to the FDCA (“Hatch-Waxman”). Hatch-Waxman permits a patent restoration term of up to five years as compensation for patent term lost during drug product development and the FDA regulatory review process. However, patent term restoration cannot extend the remaining term of a patent beyond a total of 14 years from the product or therapeutic candidate’s approval date. The patent term restoration period is generally one-half of the time between the effective date of an IND and the submission date of an NDA, plus the time between the submission date of an NDA and the approval of that application, except that the review period is reduced by any time during which the applicant failed to exercise due diligence. Only one patent applicable to an approved product or therapeutic candidate is eligible for the extension, and the application for extension must be made prior to the expiration of the patent. The USPTO, in consultation with the FDA, reviews and approves the application for any patent term extension or restoration. In the future, we intend to apply for restorations of patent term for some of our currently owned or licensed patents to add patent life beyond their current expiration date, depending on the expected length of clinical trials and other factors involved in the submission of the relevant NDA(s).

ANDA Approval Process for Generic Drugs

Hatch-Waxman also established an abbreviated FDA approval process for generic drugs that are shown to be pharmaceutically equivalent and bioequivalent to drugs previously approved by the FDA through the NDA process. Approval to market and distribute these drugs is obtained by filing an abbreviated new drug application, or ANDA, with the FDA. An ANDA provides for the marketing of a drug product that has the same active ingredients in the same strengths and dosage form as the listed drug and has been shown to be bioequivalent to the listed drug. An ANDA is a comprehensive submission that contains, among other things, data and information pertaining to the active pharmaceutical ingredient, drug product formulation, specifications and stability of the generic drug, as well as analytical methods, manufacturing process validation data, and quality control procedures. ANDAs are termed abbreviated because they generally do not include preclinical and clinical data to demonstrate safety and effectiveness. Instead, a generic applicant must demonstrate that its product is bioequivalent to the innovator drug. In some cases involving drugs with no or limited systemic absorption, an ANDA must include clinical endpoint (efficacy) studies in order to demonstrate bioequivalence. Drugs approved in this way are commonly referred to as “generic equivalents” to the listed drug and can often be substituted by pharmacists under prescriptions written for the original listed drug.

Section 505(b)(2) NDA Approval Process

As an alternative path to FDA approval for modifications to formulations or uses of products previously approved by the FDA under a “full” NDA, an applicant may submit an NDA under Section 505(b)(2) of the FDCA. Section 505(b)(2) was enacted as part of the Hatch-Waxman Amendments and enables the applicant to rely, in part, on the FDA’s previous approval of a similar product, and/or published literature, in support of the safety and/or efficacy of its drug product. Section 505(b)(2) permits the filing of an NDA where at least some of the information required for approval comes from studies not conducted by, or for, the applicant and for which the applicant has not obtained a right of reference. If the Section 505(b)(2) applicant can establish that reliance on the FDA’s previous findings of safety and effectiveness is scientifically appropriate, it may eliminate the need to conduct certain preclinical studies or clinical trials of the new product. The FDA may also require companies to perform additional studies or measurements, including clinical trials, to support the change from the approved reference drug. The FDA may then approve the new product candidate for all, or some, of the label indications for which the reference drug has been approved or for any new indication sought by the Section 505(b)(2) applicant.

ANDA and 505(b)(2) products may be significantly less costly to bring to market than the reference listed drug, and companies that produce generic products are generally able to offer them at lower prices. Moreover, generic versions of RLDs are often automatically substituted for the RLD by pharmacies when dispensing a prescription written for the RLD. Thus, following the introduction of a generic drug, a significant percentage of the sales of any branded product or reference-listed drug is typically lost to the generic product.

ANDA and 505(b)(2) NDA Patent Certification Requirements

Any applicant who files an ANDA seeking approval of a generic equivalent version of a drug listed in the Orange Book or a Section 505(b)(2) NDA referencing a drug listed in the Orange Book must certify to the FDA, as applicable, that (1) no patent information on the drug product that is the subject of the application has been submitted to the FDA; (2) such patent has expired; (3) the date on which such patent expires; or (4) such patent is, in the applicant’s opinion, invalid or will not be infringed upon by the manufacture, use or sale of the drug product for which the application is submitted. This last certification is known as the paragraph IV certification. If an ANDA or 505(b)(2) NDA is submitted to FDA with a Paragraph IV Certification, the applicant must also provide a “Paragraph IV Notification” to the holder of the NDA for the RLD and to the owner of the listed patent(s) being challenged by the applicant, providing a detailed written statement of the bases for the applicant’s position that the relevant patent(s) is invalid or would not be infringed. If the patent owner brings a patent infringement lawsuit against the applicant within 45 days of the Paragraph IV Notification, FDA approval of the ANDA or 505(b)(2) NDA will be automatically stayed for 30 months, or until 7-1/2 years after the RLD’s NDA approval date if the ANDA or 505(b) (2) NDA was filed between 4 years and 5 years after the NDA approval. Any such stay will be terminated earlier if the court rules that the patent is invalid or would not be infringed. The applicant may, in certain circumstances, elect to submit a Section VIII statement with respect to a listed method of use patent, certifying that the proposed ANDA or 505(b)(2) product’s labeling does not contain (or carve out) any language that would infringe a method of use patented listed in the Orange Book for the RLD.

The ANDA or 505(b)(2) application also will not be approved until any applicable non-patent exclusivity listed in the Orange Book for the reference drug has expired, as described in further detail below.

Regulatory Exclusivities

New Chemical Entity Exclusivity

The Hatch-Waxman Amendments provide a period of five years of non-patent marketing exclusivity for the first approved drug containing a new chemical entity (“NCE”) as an active ingredient. An NCE is an active moiety that has not been approved by the FDA in any other NDA. A fixed combination drug product may receive NCE exclusivity if one of its active ingredients is an NCE, but not if all of its active ingredients have previously been approved. An “active moiety” is defined as the molecule or ion responsible for the drug substance’s physiological or pharmacologic action. During the five-year exclusivity period, the FDA cannot accept for filing any ANDA or 505(b)(2) NDA seeking approval of a product that contains the same active moiety, except that the FDA may accept such an application for filing after four years if the application includes a paragraph IV certification to a listed patent. In the case of such applications accepted for filing between four and five years after approval of the reference drug, the 30-month stay of approval triggered by a timely patent infringement lawsuit is extended by the amount of time necessary to extend the stay until 7-1/2 years after the approval of the reference drug NDA.

New Clinical Trial (3-Year) Exclusivity

A drug, including one approved under Section 505(b)(2), may obtain a three-year period of exclusivity for a particular indication or condition of approval, or change to a marketed product, such as a new formulation for a previously approved product, if one or more new clinical trials (other than bioavailability studies) was essential to the approval of the application or supplemental application and was conducted/sponsored by the applicant. Should this occur, the FDA would be precluded from approving any ANDA or Section 505(b)(2) application for the protected modification until after that three-year exclusivity period has run. However, unlike NCE exclusivity, the FDA can accept an application and begin the review process during the 3-year exclusivity period.

Orphan Drug Designation and Orphan Exclusivity Under the Orphan Drug Act

The FDA may grant orphan designation to a drug product intended to treat a rare disease or condition, which is generally a disease or condition that affects fewer than 200,000 individuals in the United States, or more than 200,000 individuals in the United States but for which there is no reasonable expectation that the cost of developing and making the product available in the United States for this type of disease or condition will be recovered from sales of the product.

Orphan drug designation must be requested before submitting an NDA. After the FDA grants orphan drug designation, the identity of the therapeutic agent and its potential orphan use are disclosed publicly by the FDA. Orphan drug designation does not convey any advantage in or shorten the duration of the regulatory review and approval process.

If a product that has orphan designation subsequently receives the first FDA approval for the disease or condition for which it has such designation, the product is entitled to orphan drug exclusivity, which means that the FDA may not approve any other applications to market the same drug for the same indication for seven years from the date of such approval, except in limited circumstances, such as a showing of clinical superiority to the product with orphan exclusivity by means of greater effectiveness, greater safety, or providing a major contribution to patient care or in instances of drug supply issues. However, competitors may receive approval of either a different product for the same indication or the same product for a different indication, but that could be used off-label in the orphan indication. Orphan drug exclusivity also could block the approval of one of our products for seven years if a competitor obtains approval before we do for the same product, as defined by the FDA, for the same indication we are seeking approval, or if a product candidate is determined to be contained within the scope of the competitor’s product for the same indication or disease. If one of our products is designated as an orphan drug and receives marketing approval for an indication broader than that which is designated, it may not be entitled to orphan drug exclusivity. Orphan drug status in the European Union has similar, but not identical, requirements and benefits.

Pediatric Exclusivity

Pediatric exclusivity is another type of non-patent marketing exclusivity available in the United States, and if granted, it provides for the attachment of an additional six months of marketing protection to the term of any existing regulatory exclusivity or listed patents. Under the Best Pharmaceuticals for Children Act, or BPCA, certain therapeutic candidates may obtain an additional 6 months of exclusivity if the sponsor conducts pediatric research and submits new clinical information requested in writing by the FDA, referred to as a Written Request, relating to the use of the active moiety of the product or therapeutic candidate in children. The data do not need to support a label change for pediatric use; rather, the additional protection is granted if the pediatric clinical trial is deemed to have fairly responded to the FDA’s Written Request. Although the FDA may issue a Written Request for studies on either approved or unapproved indications, it may only do so where it determines that information relating to that use of a product or therapeutic candidate in a pediatric population, or part of the pediatric population, may produce health benefits in that population. The issuance of a Written Request does not require the sponsor to undertake the described trials. This is not a patent term extension, but it effectively extends the regulatory period during which the FDA cannot approve another application.

Other Healthcare Laws and Regulations

Our business activities, including but not limited to, research, sales, promotion, distribution, medical education, and other activities following product approval will be subject to regulation by numerous federal and state regulatory and law enforcement authorities in the United States in addition to the FDA, including potentially the Department of Justice, the Department of Health and Human Services (HHS) and its various divisions, including the Office of Inspector General, the Centers for Medicare & Medicaid Services (CMS) and the Health Resources and Services Administration, the Department of Veterans Affairs, the Department of Defense, and state and local governments. Healthcare providers and third-party payors play a primary role in the recommendation and use of pharmaceutical products that are granted marketing approval. Arrangements with third-party payors, existing or potential customers, and referral sources, including healthcare providers, are subject to broadly applicable fraud and abuse laws and regulations, and these laws and regulations may constrain the business or financial arrangements and relationships through which manufacturers conduct clinical research, market, sell, and distribute the products for which they obtain marketing approval. Such restrictions under applicable federal and state healthcare laws and regulations include the following:

●

The federal Anti-Kickback Statute, which prohibits, among other things, persons and entities from knowingly and willfully soliciting, receiving, offering or paying remuneration, directly or indirectly, in cash or kind, in exchange for, or to induce, either the referral of an individual for, or the purchase, order or recommendation of, any good or service for which payment may be made under federal healthcare programs such as the Medicare and Medicaid programs. This statute has been interpreted to apply to arrangements between pharmaceutical manufacturers, on the one hand, and prescribers, purchasers, formulary managers, and other individuals and entities on the other. The Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act (collectively, the ACA), amended the intent requirement of the federal Anti-Kickback Statute such that a person or entity no longer needs to have actual knowledge of this statute or specific intent to violate it in order to commit a violation;

●

The federal civil and criminal false claims, including the civil FCA, and Civil Monetary Penalties Laws which prohibit, among other things, individuals or entities from knowingly presenting, or causing to be presented, claims for payment from Medicare, Medicaid or other third-party payors that are false or fraudulent, or making a false statement to avoid, decrease, or conceal an obligation to pay money to the federal government. Certain marketing practices, including off-label promotion, also may implicate the FCA. In addition, the ACA codified case law that a claim including items or services resulting from a violation of the federal Anti-Kickback Statute constitutes a false or fraudulent claim for purposes of the FCA;

●

The federal Physician Payments Sunshine Act, which requires certain manufacturers of drugs, devices, therapeutic products and medical supplies for which payment is available under Medicare, Medicaid, or the Children’s Health Insurance Program, with specific exceptions, to report annually to the Centers for Medicare & Medicaid Services, or the CMS, information related to payments and other transfers of value made to physicians (defined to include doctors, dentists, optometrists, podiatrists and chiropractors), certain other healthcare professionals (such as physician assistants and nurse practitioners), and teaching hospitals, and ownership and investment interests held by physicians and other healthcare providers and their immediate family members;

●

Health Insurance Portability and Accountability Act of 1996 (HIPAA) prohibits knowingly and willfully executing, or attempting to execute, a scheme to defraud or to obtain, by means of false or fraudulent pretenses, representations or promises, any of the money or property owned by, or under the custody or control of, a healthcare benefit program, regardless of whether the payor is public or private, in connection with the delivery or payment for health care benefits, knowingly and willfully embezzling or stealing from a health care benefit program, willfully obstructing a criminal investigation of a health care offense and knowingly and willfully falsifying, concealing, or covering up by any trick or device a material fact or making any materially false statements in connection with the delivery of, or payment for, healthcare benefits, items, or services relating to healthcare matters. Additionally, the ACA amended the intent requirement of certain of these criminal statutes under HIPAA so that a person or entity no longer needs to have actual knowledge of the statute, or the specific intent to violate it, to have committed a violation; and

●

State and foreign law equivalents of each of the above federal laws, such as anti-kickback and false claims laws which may apply to items or services reimbursed by any third-party payor, including commercial insurers; state laws that require pharmaceutical companies to comply with the pharmaceutical industry’s voluntary compliance guidelines and the relevant compliance guidance promulgated by the federal government or otherwise restrict payments that may be made to healthcare providers and other potential referral sources; state laws that require drug manufacturers to report information related to payments and other transfers of value to physicians and other healthcare providers and drug pricing and/or marketing expenditures; and state and local laws requiring the registration of pharmaceutical sales representatives and state laws governing the privacy and security of health information in certain circumstances, many of which differ from each other in significant ways and may not have the same effect, thus complicating compliance efforts.

Further, we may be subject to data privacy and security regulations by both the federal government and the states and foreign jurisdictions in which we conduct our business. HIPAA, as amended by the Health Information Technology for Clinical Health Act of 2009 (HITECH), and its respective implementing regulations impose certain requirements, including mandatory contractual terms, on covered entities, business associates, and their covered subcontractors relating to the privacy, security, and transmission of certain individually identifiable health information known as protected health information. Among other things, HITECH, through its implementing regulations, makes HIPAA’s security standards and certain privacy standards directly applicable to business associates, defined as a person or organization, other than a member of a covered entity’s workforce, that creates, receives, maintains, or transmits protected health information on behalf of a covered entity for a function or activity regulated by HIPAA. HITECH also strengthened the civil and criminal penalties that may be imposed against covered entities, business associates, subcontractors, and individuals, and gave state attorneys general new authority to file civil actions for damages or injunctions in federal courts to enforce the federal HIPAA laws and seek attorneys’ fees and costs associated with pursuing federal civil actions. In addition, other federal and state laws may govern the privacy and security of health and other information in certain circumstances, many of which differ from each other in significant ways and may not be preempted by HIPAA, thus complicating compliance efforts.

To the extent that any of our products are sold in a foreign country, we may be subject to similar foreign laws and regulations, which may include, for instance, applicable post-marketing requirements, including safety surveillance, anti-fraud and abuse laws, and implementation of corporate compliance programs and reporting of payments or transfers of value to healthcare professionals.

In the EU, the data privacy laws are generally perceived to be stricter than those that apply in the United States and include specific requirements for the transfer of personal data outside the EU to the United States to ensure that EU standards of data privacy will be applied to such data.

Violation of the laws described above or any other governmental laws and regulations may result in significant penalties, including administrative, civil and criminal penalties, damages, fines, the curtailment or restructuring of operations, the exclusion from participation in federal and state healthcare programs, disgorgement, contractual damages, reputational harm, diminished profits and future earnings, imprisonment, and additional reporting requirements and oversight if a person becomes subject to a corporate integrity agreement or similar agreement to resolve allegations of non-compliance with these laws. Furthermore, efforts to ensure that business activities and business arrangements comply with applicable healthcare laws and regulations can be costly for manufacturers of branded prescription products.

Coverage and Reimbursement

Significant uncertainty exists as to the coverage and reimbursement status of any products for which we may obtain regulatory approval. In the United States, sales of any product candidates for which regulatory approval for commercial sale is obtained will depend in part on the availability of coverage and adequate reimbursement from third-party payors. Third-party payors include government authorities and health programs in the United States, such as Medicare and Medicaid, managed care providers, private health insurers, and other organizations. These third-party payors are increasingly reducing reimbursements for medical products and services. The process for determining whether a payor will provide coverage for a drug product may be separate from the process for setting the reimbursement rate that the payor will pay for the drug product. Third-party payors may limit coverage to specific drug products on an approved list, or formulary, which might not include all of the FDA-approved drugs for a particular indication. Additionally, the containment of healthcare costs has become a priority of federal and state governments, and the prices of drugs have been a focus in this effort. The U.S. government, state legislatures, and foreign governments have shown significant interest in implementing cost-containment programs, including price controls, restrictions on reimbursement, and requirements for substitution of generic products. Adoption of price controls and cost-containment measures, and adoption of more restrictive policies in jurisdictions with existing controls and measures, could further limit our net revenue and results.

A payor’s decision to provide coverage for a drug product does not imply that an adequate reimbursement rate will be approved. Further, coverage and reimbursement for drug products can differ significantly from payor to payor. As a result, the coverage determination process is often a time-consuming and costly process that will require us to provide scientific and clinical support for the use of our products to each payor separately, with no assurance that coverage and adequate reimbursement will be applied consistently or obtained in the first instance.

Third-party payors are increasingly challenging the price and examining the medical necessity and cost of medical products and services, in addition to their safety and efficacy. New metrics frequently are used as the basis for reimbursement rates, such as average sales price, average manufacturer price, and actual acquisition cost. In order to obtain coverage and reimbursement for any product that might be approved for sale, it may be necessary to conduct expensive pharmacoeconomic studies in order to demonstrate the medical necessity and rationale of the cost of the product, in addition to the costs required to obtain regulatory approvals. If third-party payors do not consider a product to be cost-saving when compared to other available therapies, they may not cover the product after approval as a benefit under their plans, or if they do, the level of payment may not be sufficient to allow a company to sell its products at a profit.

The marketability of any product candidates for which we or our collaborators receive regulatory approval for commercial sale may suffer if the government and third-party payors fail to provide adequate coverage and reimbursement. In addition, emphasis on managed care in the United States has increased, and we expect it will continue to increase the pressure on pharmaceutical pricing. Coverage policies and third-party reimbursement rates may change at any time. Even if favorable coverage and reimbursement status are attained for one or more products for which we or our collaborators receive regulatory approval, less favorable coverage policies and reimbursement rates may be implemented in the future. The cost containment measures that healthcare payors and providers are instituting, and any healthcare reform, could significantly reduce our revenues from the sale of any approved product candidates. We cannot provide any assurances that we will be able to obtain and maintain third-party coverage or adequate reimbursement for our product candidates in whole or in part.

In the EU, pricing and reimbursement schemes vary widely from country to country. Some countries provide that products may be marketed only after a reimbursement price has been agreed upon. Some countries may require the completion of additional studies that compare the cost of a particular product candidate to currently available therapies. EU member states may approve a specific price for a product, or they may instead adopt a system of direct or indirect controls on the profitability of the company placing the product on the market. Other member states allow companies to fix their own prices for products, but monitor and control company profits. The downward pressure on health care costs has become intense. As a result, increasingly high barriers are being erected to the entry of new products. In addition, in some countries, cross-border imports from low-priced markets exert competitive pressure that may reduce pricing within a country. Any country that has price controls or reimbursement limitations may not allow favorable reimbursement and pricing arrangements.

Health Reform

The United States and some foreign jurisdictions are considering or have enacted a number of legislative and regulatory proposals to change the healthcare system in ways that could affect our ability to sell our products profitably. Among policy makers and payors in the United States and elsewhere, there is significant interest in promoting changes in healthcare systems with the stated goals of containing healthcare costs, improving quality, or expanding access. In the United States, the pharmaceutical industry has been a particular focus of these efforts and has been significantly affected by federal and state legislative initiatives, including those designed to limit the pricing, coverage, and reimbursement of pharmaceutical products, especially under government-funded health care programs, and increased governmental control of drug pricing.

By way of example, in March 2010, the ACA was signed into law, intended to broaden access to health insurance, reduce or constrain the growth of healthcare spending, enhance remedies against fraud and abuse, add transparency requirements for the healthcare and health insurance industries, impose taxes and fees on the healthcare industry, and impose additional health policy reforms. Among the provisions of the ACA of importance to our business are:

●

An annual, non-deductible fee on any entity that manufactures or imports specified branded prescription drugs and biologic agents, apportioned among these entities according to their market share in certain government healthcare programs;

●

An increase in the statutory minimum rebates a manufacturer must pay under the Medicaid Drug Rebate Program to 23.1% and 13.0% of the average manufacturer price for branded and generic drugs, respectively;

●

A methodology by which rebates owed by manufacturers under the Medicaid Drug Rebate Program are calculated for drugs that are inhaled, infused, instilled, implanted, or injected;

●

Extension of a manufacturer’s Medicaid rebate liability to covered drugs dispensed to individuals who are enrolled in Medicaid managed care organizations;

●

Expansion of eligibility criteria for Medicaid programs by, among other things, allowing states to offer Medicaid coverage to certain individuals with income at or below 133% of the federal poverty level, thereby potentially increasing a manufacturer’s Medicaid rebate liability;

●

A Medicare Part D coverage gap discount program, in which manufacturers must now agree to offer 70% point-of-sale discounts off negotiated prices of applicable brand drugs to eligible beneficiaries during their coverage gap period, as a condition for a manufacturer’s outpatient drugs to be covered under Medicare Part D;

●

Expansion of the entities eligible for discounts under the Public Health Service pharmaceutical pricing program; and

●

A Patient-Centered Outcomes Research Institute to oversee, identify priorities in, and conduct comparative clinical research, along with funding for such research.

There have been executive, judicial, and Congressional challenges to certain aspects of the ACA. For example, on June 17, 2021, the U.S. Supreme Court dismissed a challenge on procedural grounds that argued the ACA is unconstitutional in its entirety because the “individual mandate” was repealed by Congress. Thus, the ACA will remain in effect in its current form. Further, prior to the U.S. Supreme Court ruling, on January 28, 2021, President Biden issued an executive order that initiated a special enrollment period for purposes of obtaining health insurance coverage through the ACA marketplace. The executive order also instructed certain governmental agencies to review and reconsider their existing policies and rules that limit access to healthcare, including, among others, re-examining Medicaid demonstration projects and waiver programs that include work requirements, and policies that create unnecessary barriers to obtaining access to health insurance coverage through Medicaid or the ACA. In addition, in August 2022, President Biden signed the Inflation Reduction Act of 2022 (the “IRA”) into law, which, among other things, extends enhanced subsidies for individuals purchasing coverage in ACA marketplaces through plan year 2025. The IRA also eliminates the “donut hole” under the Medicare Part D program beginning in 2025 by significantly lowering the beneficiary’s maximum out-of-pocket cost through a newly established manufacturer discount program.

Other legislative changes have been proposed and adopted in the United States since the ACA. For example, through the process created by the Budget Control Act of 2011, there are automatic reductions of Medicare payments to providers up to 2% per fiscal year, which went into effect in April 2013 and, following passage of the BBA and the Infrastructure Investment and Jobs Act, will remain in effect until 2031 unless additional Congressional action is taken. However, COVID-19 relief support legislation suspended the 2% Medicare sequester from May 1, 2020 through March 31, 2022. Under current legislation, the actual reduction in Medicare payments will vary from 1% in 2022 to up to 4% in the final fiscal year of this sequester.

The heightened governmental scrutiny in the United States of pharmaceutical pricing practices in light of the rising cost of prescription drugs and biologics has resulted in executive orders, congressional inquiries and proposed and enacted federal and state legislation designed to, among other things, bring more transparency to product pricing, review the relationship between pricing and manufacturer patient programs, and reform government program reimbursement methodologies for products. At the federal level, President Trump used several means to propose or implement drug pricing reform, including through federal budget proposals, executive orders, and policy initiatives. For example, on July 24, 2020, and September 13, 2020, the Trump administration announced several executive orders related to prescription drug pricing. Consequently, in September 2020, the FDA released guidance and a final rule to provide a pathway for states to construct and submit plans to import drugs from Canada. On November 20, 2020, the HHS finalized a regulation removing safe harbor protection for price reductions from pharmaceutical manufacturers to plan sponsors under Part D, either directly or through pharmacy benefit managers, unless the price reduction is required by law. The rule also creates new safe harbors for price reductions reflected at the point-of-sale for certain fixed fee arrangements between pharmacy benefit managers and manufacturers. The implementation of the rule has been delayed until 2032. Additionally, on March 11, 2021, President Biden signed the American Rescue Plan Act of 2021 into law, which eliminates the statutory Medicaid drug rebate cap, currently set at 100% of a drug’s average manufacturer price, for single-source and innovator multiple-source drugs, beginning January 1, 2024. In July 2021, the Biden administration released an executive order, “Promoting Competition in the American Economy,” with multiple provisions aimed at prescription drugs. In response to Biden’s executive order, on September 9, 2021, HHS released a Comprehensive Plan for Addressing High Drug Prices that outlines principles for drug pricing reform and sets out a variety of potential legislative policies that Congress could pursue, as well as potential administrative actions HHS can take to advance these principles. In addition, the IRA directs the Secretary of HHS to establish a Drug Price Negotiation Program (the Program) to lower prices for certain single-source prescription drugs and biologics covered under Medicare Parts B and D, based on criteria established under the IRA. Under the Program, the Secretary of HHS will publish a list of “selected drugs,” and will then negotiate maximum fair prices (MFP) with their manufacturers. Beginning in 2026, the first year of the Program, the number will be limited to 10 Part D drugs and biologics. By 2029, and in subsequent years thereafter, the number will increase to 20 drugs and biologics covered under Part D and Part B. Agreements between HHS and manufacturers will remain in place until a drug or biologic is no longer considered a “selected drug” for negotiation purposes. Manufacturers who do not comply with the negotiated prices set under the Program will be subject to an excise tax based on a percentage of total sales of a “selected drug” up to 95% and the potential of civil monetary penalties. Further, the IRA imposes rebates under Medicare Part B and Medicare Part D to penalize price increases that outpace inflation. In addition, the Biden administration released an additional executive order on October 14, 2022, directing HHS to submit a report within ninety (90) days on how the Center for Medicare and Medicaid Innovation can be further leveraged to test new models for lowering drug costs for Medicare and Medicaid beneficiaries.

At the state level, individual states in the United States have increasingly passed legislation and implemented regulations designed to control pharmaceutical and therapeutic product pricing, including price or patient reimbursement constraints, discounts, restrictions on certain product access and marketing cost disclosure and transparency measures, and, in some cases, designed to encourage importation from other countries and bulk purchasing. Some third-party payors also require pre-approval of coverage for new or innovative devices or therapies before they will reimburse healthcare providers that use such therapies.

We expect that these initiatives, as well as other healthcare reform measures that may be adopted in the future, as well as the trend toward managed healthcare and increasing influence of managed care organizations, may result in more rigorous coverage criteria and lower reimbursement, and in additional downward pressure on the price that we receive for any approved product. It is also possible that additional governmental action is taken in response to the COVID-19 pandemic. Any reduction in reimbursement from Medicare or other government-funded programs may result in a similar reduction in payments from private payors. The implementation of current and future cost containment measures or other healthcare reforms may adversely affect our operations and prevent us from being able to generate revenue, attain profitability, or commercialize our product candidates.

Data Privacy and Security

In the ordinary course of our business, we collect, process, and store confidential and sensitive information, including personal information, intellectual property, trade secrets, and proprietary information owned or controlled by ourselves or other third parties. We, and third parties upon whom we rely, use sophisticated information technology, software, and services to process, store, use, generate, transfer, and disclose information, as well as other sensitive information controlled by ourselves or other third parties.

We are also subject to federal, state, and foreign data privacy and security laws and regulations. In the United States, numerous federal and state laws and regulations, including state data breach notification laws, state health information privacy laws, and federal and state consumer protection laws and regulations (e.g., Section 5 of the FTC Act), govern the collection, use, disclosure, and protection of health-related and other personal information could apply to our operations or the operations of our partners, vendors, or other third parties on whom we rely. The legislative and regulatory framework related to the collection, use, retention, safeguarding, disclosure, sharing, transfer, security, and other processing of personal data worldwide is rapidly evolving. The number and scope of data protection laws and regulations are changing, subject to differing applications and interpretations, and may be inconsistent among jurisdictions or in conflict with other rules, laws, or other data processing obligations. Efforts to ensure that our current and future business arrangements, including our relationship with our CROs or other vendors who process data on our behalf, comply with applicable data privacy and data security laws and regulations will involve substantial costs.

For example, HIPAA, as amended by HITECH, and its implementing regulations, impose requirements relating to the privacy, security and transmission of individually identifiable health information on certain health care providers, health plans and health care clearinghouses, known as covered entities, as well as their business associates and covered subcontractors that perform certain services that involve creating, receiving, maintaining or transmitting individually identifiable health information for or on behalf of such covered entities. Entities that are found to be in violation of HIPAA as the result of a breach of unsecured protected health information, a complaint about privacy practices or an audit by HHS, may be subject to significant civil, criminal and administrative fines and penalties and/or additional reporting and oversight obligations if required to enter into a resolution agreement and corrective action plan with HHS to settle allegations of HIPAA non-compliance. Further, entities that knowingly obtain, use, or disclose individually identifiable health information maintained by a HIPAA covered entity in a manner that is not authorized or permitted by HIPAA may be subject to civil and criminal penalties. Even when HIPAA does not apply, according to the FTC, violating consumers’ privacy rights or failing to take appropriate steps to keep consumers’ personal information secure may constitute unfair acts or practices in or affecting commerce in violation of Section 5 of the FTC Act. The FTC expects a company’s data security measures to be reasonable and appropriate in light of the sensitivity and volume of consumer information it holds, the size and complexity of its business, and the cost of available tools to improve security and reduce vulnerabilities. Individually identifiable health information is considered sensitive data that merits stronger safeguards.

Likewise, we expect that there will continue to be new proposed laws, regulations, and industry standards relating to privacy and data protection in the United States, the EU, and other jurisdictions, such as the California Consumer Privacy Act of 2018 (CCPA), which has been characterized as the first “GDPR-like” privacy statute to be enacted in the United States. Although the CCPA exempts certain data processed in the context of clinical trials, the CCPA, to the extent applicable to our business and operations, may increase our compliance costs and potential liability with respect to the personal information we maintain about California residents. The CCPA among other effects, creates individual privacy rights for California consumers (as defined in the law), places increased privacy and security obligations on entities handling certain personal data of consumers or households, requires covered companies to provide disclosures to consumers regarding data collection, use and sharing practices, requires covered companies to allow users to opt-out of certain sales or transfers of personal information, and provides consumers with a private right of action for certain data breaches. The CCPA became effective on January 1, 2020, and the California Attorney General’s authority to begin bringing enforcement actions began on July 1, 2020. As currently written, the CCPA may impact our business activities and exemplifies the vulnerability of our business to the evolving regulatory environment related to personal data and protected health information. Further, the California Privacy Rights Act (CPRA) was recently voted into law by California residents. The CPRA significantly amends the CCPA and imposes additional data protection obligations on covered companies doing business in California, including additional consumer rights processes and opt-outs for certain uses of sensitive data. It also creates a new California data protection agency specifically tasked to enforce the law, which would likely result in increased regulatory scrutiny of California businesses in the areas of data protection and security. The substantive requirements for businesses subject to the CPRA went into effect on January 1, 2023, and became enforceable on July 1, 2023. A similar law, the Consumer Data Protection Act (CDPA), was recently passed in Virginia and went into effect on January 1, 2023.

We are also or will become subject to privacy laws in the jurisdictions in which we are established or in which we sell or market our products or run clinical trials. For example, in the EU, we are subject to Regulation (EU) 2016/679, the GDPR, in relation to our collection, control, processing, and other use of personal data (i.e., data relating to an identified or identifiable living individual). We process personal data in relation to participants in our clinical trials in the European Economic Area (EEA), including the health and medical information of these participants. The GDPR is directly applicable in each EU and EEA Member State; however, it provides that EU and EEA Member States may introduce further conditions, including limitations which could limit our ability to collect, use, and share personal data (including health and medical information), or could cause our compliance costs to increase, ultimately having an adverse impact on our business. As noted above, the GDPR imposes onerous accountability obligations requiring data controllers and processors to maintain a record of their data processing and implement policies as part of its mandated privacy governance framework. It also requires data controllers to be transparent and disclose to data subjects (in a concise, intelligible and easily accessible form) how their personal information is to be used, imposes limitations on retention of personal data; defines for the first time pseudonymized (i.e., key-coded) data; introduces mandatory data breach notification requirements; and sets higher standards for data controllers to demonstrate that they have obtained valid consent for certain data processing activities. We are also subject to EEA rules with respect to cross-border transfers of personal data out of the EEA.

As noted above, recent legal developments in the EU have created complexity and uncertainty regarding transfers of personal data from the EEA to the United States, e.g. on July 16, 2020, the Court of Justice of the European Union (CJEU), invalidated the EU-U.S. Privacy Shield Framework, or the Privacy Shield, under which personal data could be transferred from the EEA to U.S. entities who had self-certified under the Privacy Shield scheme. While the CJEU upheld the adequacy of the standard contractual clauses (a standard form of contract approved by the European Commission as an adequate personal data transfer mechanism, and potential alternative to the Privacy Shield), it made clear that reliance on them alone may not necessarily be sufficient in all circumstances. Use of the standard contractual clauses must now be assessed on a case-by-case basis, taking into account the legal regime applicable in the destination country, in particular applicable surveillance laws and rights of individuals, and additional measures and/or contractual provisions may need to be put in place; however, the nature of these additional measures is currently uncertain.

On June 4, 2021, the European Commission adopted new standard contractual clauses under the GDPR for data transfers from entities that are subject to the GDPR to transfer personal data outside of the EEA. The new standard contractual clauses impose additional obligations, including the obligation to conduct a transfer impact assessment and, depending on a party’s role in the transfer, to implement additional security measures and to update internal privacy practices. If we elect to rely on the standard contractual clauses for data transfers, we may be required to incur significant time and resources to update our contractual arrangements and to comply with new obligations. Additionally, on September 8, 2020, the Swiss Data Protection Authority (the Federal Data Protection and Information Commissioner) concluded that the Swiss-U.S. Privacy Shield does not provide an adequate level of protection for personal data transfer from Switzerland to the U.S. pursuant to the Swiss Federal Act on Data Protection.

As supervisory authorities issue further guidance on personal data export mechanisms, including circumstances where the standard contractual clauses cannot be used, and/or start taking enforcement action, we could suffer additional costs, complaints and/or regulatory investigations or fines, and/or if we are otherwise unable to transfer personal data between and among countries and regions in which we operate, it could affect the manner in which we provide our services, the geographical location or segregation of our relevant systems and operations, and could adversely affect our financial results.

We are subject to the supervision of local data protection authorities in those EU jurisdictions where we are established or otherwise subject to the GDPR. Fines for certain breaches of the GDPR are significant: up to the greater of €20.0 million or 4% of total global annual turnover. Further, following the withdrawal of the United Kingdom from the EU on January 31, 2020, pursuant to the transitional arrangements agreed between the United Kingdom and the EU, we will have to comply with the GDPR and separately the GDPR as implemented in the United Kingdom, each regime having the ability to fine up to the greater of €20 million/£17 million or 4% of global turnover. Following December 31, 2020, and the expiry of the post-Brexit transitional arrangements between the United Kingdom and EU, although it is likely that the data protection obligations of the GDPR will continue to apply to UK-related processing of personal data in substantially unvaried form and fashion, for at least the short term thereafter, the relationship between the United Kingdom and the EU in relation to certain aspects of data protection law remains unclear. For example, it is not yet clear whether the United Kingdom will be the subject of a so-called adequacy decision of the European Commission, and it is therefore unclear how data transfers between EU/EEA Member States and the United Kingdom will be treated. Any changes relating to the UK and EU position regarding aspects of data protection law may lead to additional compliance costs and could increase our overall risk. In addition to the foregoing, a breach of the GDPR or other applicable privacy and data protection laws and regulations could result in regulatory investigations, reputational damage, orders to cease/change our use of data, enforcement notices, an inability to process personal data or to operate in certain jurisdictions, or potential civil claims, including class action type litigation.

Moreover, we use third-party service providers and subprocesses to help us operate our business and engage in processing on our behalf. If we, our service providers, partners, or other relevant third-parties have experienced, or in the future experience, any security incident(s) that result in any data loss, deletion or destruction, unauthorized access to, loss of, unauthorized acquisition or disclosure of, or inadvertent exposure or disclosure of sensitive information, or compromise related to the security, confidentiality, integrity of our (or their) information technology, software, services, communications or data, it may result in a material adverse impact, including without limitation, regulatory investigations or enforcement actions, litigation, or an inability to process data in some jurisdictions. Furthermore, applicable data protection laws, privacy policies, and data protection obligations may require us to notify relevant stakeholders of security breaches, including affected individuals, customers, and regulators. Such disclosures are costly, and the disclosure or the failure to comply with such requirements could result in a material adverse impact, including, without limitation, regulatory investigations or enforcement actions.

For more information on the potential impact of the GDPR, and associated EEA data protection laws, on our business, see the section titled “Risk Factors — Our relationships with healthcare professionals, clinical investigators, CROs, and third-party payors may be subject to healthcare fraud and abuse laws, exposing us to criminal sanctions, civil penalties, damages, exclusion from government programs, reputational harm, and financial losses.”

Additional Regulation

In addition to the foregoing, state and federal laws regarding environmental protection and hazardous substances, including the Occupational Safety and Health Act, the Resource Conservation and Recovery Act, and the Toxic Substances Control Act, affect our business. These and other laws govern the use, handling, and disposal of various biologic, chemical, and radioactive substances used in, and wastes generated by, operations. If our operations result in contamination of the environment or expose individuals to hazardous substances, we could be liable for damages and governmental fines. Equivalent laws have been adopted in other countries that impose similar obligations.

U.S. Foreign Corrupt Practices Act

The U.S. Foreign Corrupt Practices Act (FCPA) prohibits U.S. corporations and individuals from engaging in certain activities to obtain or retain business abroad or to influence a person working in an official capacity. It is illegal to pay, offer to pay or authorize the payment of anything of value, directly or indirectly, to any foreign government official, government staff member, official or employee of a public international organization, or a political party or political candidate for the purpose of influencing any act or decision of the foreign entity in an attempt to obtain or retain business or to otherwise influence a person working in an official capacity. The scope of the FCPA includes interactions with healthcare professionals of foreign state-owned or affiliated hospitals, universities, or research institutions. The FCPA also obligates companies whose securities are listed in the United States to comply with accounting provisions requiring the company to maintain books and records that accurately and fairly reflect all transactions of the corporation, including international subsidiaries, and to devise and maintain an adequate system of internal accounting controls for international operations. Activities that violate the FCPA, even if they occur wholly outside the United States, can result in criminal and civil fines, imprisonment, disgorgement, oversight, suspension, and debarment from government contracts, and refusal of orders under existing government contracts.

Recent Developments

On April 23, 2026, we completed our direct listing, and our common stock began trading on the Nasdaq Capital Market under the symbol “LABT.”

Employees

As of the date of this registration statement, we have 5 full-time employees, all employed in the United States.

Description of Properties

Our corporate headquarters is located in leased office space at 8031 Cooper Creek Boulevard, Unit 103, University Park, Florida 34201.

Legal Proceedings

From time to time, the Company may be subject to various claims, lawsuits, and other legal and administrative proceedings arising in the ordinary course of business. Defending such proceedings is costly and can impose a significant burden on management and employees. The results of any current or future litigation cannot be predicted with certainty, and regardless of the outcome, litigation can have an adverse impact on us because of defense and settlement costs, diversion of management resources, and other factors. Other than as set forth below, the company is not presently a party to any litigation, the outcome of which, if determined adversely to us, would, in our estimation, have a material adverse effect on our business, operating results, cash flows, or financial condition. The Company is not subject to any legal proceedings at this time.

MANAGEMENT

The following table sets forth certain information as of the date of this prospectus about our executive officers and members of our Board:

Directors and Executive Officers	Age	Position/Title
Doug Manion, M.D., FRCP (C)	65	Chairman of the Board
Kelvin Cooper, Ph.D.	71	Chief Executive Officer, SVP Research & Development, Director
Peter Ceccacci	71	Chief Financial Officer, VP Administration
Thomas Balzer, M.D., Ph.D.	67	Chief Medical Officer, SVP Clinical Development
Leonard J. DeRoma	71	Director
Joseph Tucker, Ph.D.	57	Director

Executive Officers and Directors

Doug Manion, M.D., FRCP (C) — Chairman of the Board, age 65, has over 20 years of experience in the pharmaceutical industry in senior management. He has served as Chief Executive Officer and Director of Flare Therapeutics since April 2024. Previously, he held executive roles at six pharmaceutical companies, including Chief Executive Officer of Aclaris Therapeutics from July 2022 to January 2024, Executive Vice President of Research and Development at Arena Pharmaceuticals from July 2021 to March 2022, and Chief Executive Officer of Kleo Pharmaceuticals from May 2017 to January 2021. Dr. Manion holds an undergraduate degree in Civil Engineering and an M.D. from the University of Ottawa. He also completed a Clinical and Bench Research Fellowship at Massachusetts General Hospital and Harvard Medical School.

Dr. Manion has served as our director since July 2021. We believe that Dr. Manion’s extensive corporate and leadership experience in his executive roles at six pharmaceutical companies and his knowledge of Lakewood Amedex Biotherapeutics Inc.’s business qualifies him to serve as a director and Chairman of the Board.

Kelvin Cooper, Ph.D. — Chief Executive Officer, SVP Research & Development, age 71, has more than 45 years of executive experience in the pharmaceutical industry, spanning all aspects of drug discovery and development across multiple therapeutic areas, including infectious diseases, cancer, respiratory, immunology, and inflammation. Dr. Cooper joined Lakewood-Amedex Biotherapeutics Inc. in 2021 as Executive Director of Drug Development. In October 2023, he was promoted to Chief Operating Officer and Senior Vice President of Research and Development, and in February 2025, he was appointed Chief Executive Officer. Prior to joining Lakewood-Amedex Biotherapeutics Inc., Dr. Cooper was the principal and owner of KC Pharma Consulting Inc. from mid-2011 to 2021. Before that, he spent 30 years at Pfizer, where he held various executive leadership roles in both R&D and Commercial divisions. Dr. Cooper holds an undergraduate degree in chemistry from the University of Kingston, London, and a Ph.D. in organic chemistry from the University of Nottingham, England. He is a past recipient of the Captain Black Award for Science and has authored 50 publications and holds 37 patents.

Dr. Cooper has served as our director since February 2025. We believe that Dr. Cooper is well qualified to serve as our director and CEO because of his extensive experience in his non-clinical executive positions at Pfizer, as well as his deep knowledge of Lakewood-Amedex Biotherapeutics Inc.’s portfolio and scientific approach.

Peter Ceccacci — Chief Financial Officer and VP Administration, age 71, Mr. Ceccacci is a seasoned financial executive with more than 30 years of leadership experience across various industries, including healthcare, technology, and public accounting. Mr. Ceccacci joined Lakewood-Amedex Biotherapeutics Inc. in 2009 on a part-time basis. He became a full-time employee in 2021 when he was appointed Chief Accounting Officer, and he was promoted to Chief Financial Officer in February 2025. With a background as an equity partner in public accounting firms and as a senior finance executive, Mr. Ceccacci brings expertise in strategic planning, raising capital, financial planning and analysis, budgeting and forecasting, accounting, and tax compliance. His prior roles include serving as Chief Financial Officer at Genius Central Systems Inc. from July 2019 to March 2021, and as a partner at accounting firms including EisnerAmper and RD Hunter and Company LLP. Mr. Ceccacci holds a Bachelor of Science in Accounting from Susquehanna University and holds a Certified Public Accountant license in Florida and New Jersey (both licenses currently inactive).

We believe that Mr. Ceccacci is well qualified to serve as our Chief Financial Officer because of his extensive experience in financial strategy and management, as well as his knowledge of the finances and systems at Lakewood-Amedex Biotherapeutics Inc.

Thomas Balzer, M.D., Ph.D. — Chief Medical Officer, SVP Clinical Development, age 66, is an accomplished healthcare professional with extensive experience in clinical drug development and medical affairs. Dr Balzer joined Lakewood-Amedex Biotherapeutics Inc. in November 2022 as Senior Vice President of Clinical Development and was promoted to Chief Medical Officer in October 2023. From July 2021 to February 2022, he served as Head of Clinical Development at Thrive Detect, an Exact Sciences Company, where he led the development of a multi-cancer detection liquid biopsy assay. Dr. Balzer spent over 25 years in various roles at Bayer HealthCare, ultimately serving as Vice President and Global Head of Medical Affairs & Clinical Development Radiology at Bayer U.S. in New Jersey, where he oversaw the company’s medical imaging business. Dr. Balzer attended medical school in Berlin, Germany, and completed his residency at the Benjamin Franklin Hospital of the Free University of Berlin. He is board-certified in Germany in Internal Medicine, and he earned his Ph.D. from the Free University for research in neuro-endocrine pharmacology.

We believe that Dr. Balzer is well qualified to serve as our Chief Medical Officer because of his deep knowledge and experience in medical executive positions at Bayer Health Care, as well as his deep knowledge of Lakewood-Amedex Biotherapeutics Inc’s portfolio and scientific approach.

Leonard J. DeRoma — Director, age 71, is an experienced entrepreneur and senior manager with a strong track record of leadership in the banking and securities industries. He has extensive expertise in securities, U.S. Securities and Exchange Commission (SEC) matters, risk management, business development, and derivatives. Mr. DeRoma is the co-founder of Invictus Group, established in 2008. Since 2020, he has served as Chairman of the Board of SN2N LLC, an early-stage cybersecurity company. He has also been a director at Park City Capital since 2016. Mr. DeRoma began his career at Citibank and has held senior roles in fixed-income trading at several major financial institutions, including Citibank, Lehman Brothers, Barclays Capital, and KeyBank-McDonald Investments. He holds a B.S. in Electrical Engineering from the Massachusetts Institute of Technology and an M.B.A. from Harvard Business School.

Mr. DeRoma has served as our director since July 2017. We believe that Mr. DeRoma is well qualified to serve as our director because of his extensive business experience.

Joseph Tucker, Ph.D. — Director, age 57, has served as Chief Executive Officer and Director of Enveric Biosciences Inc. (NASDAQ: ENVB) since September 2021, following Enveric's acquisition of MagicMed Industries, where he served as Chief Executive Officer, President, and Director beginning in 2020. From 2016 to 2022, Dr. Tucker served as Chief Executive Officer, President, and Director of VirTech Bio, Inc., an early-stage biotechnology company. From 2014 to 2020, Dr. Tucker served as Executive Chairman, Chief Executive Officer, President, and Director of Willow Biosciences Inc. (TSX: WLLW) and its predecessor company, Epimeron Inc.. From 2004 to 2007, Dr. Tucker served as Chief Executive Officer, President, and Director of Stem Cell Therapeutics Corp. (TSX: SSS), which he took public via initial public offering and which ultimately merged into Trillium Therapeutics Inc. (NASDAQ: TRIL), later acquired by Pfizer Inc. (NYSE: PFE). Dr. Tucker previously served as Vice President of Resverlogix (TSX: RVX) from 2003 to 2004 and Vice President of Neurostasis, Inc. from 2001 to 2003. Earlier in his career, Dr. Tucker served as a lead health care analyst at Lightyear Capital Inc. and Acumen Capital Partners Inc. from 2000 to 2001. Dr. Tucker holds a Ph.D. and B.Sc. from the University of Calgary and has earned the Certified Financial Planner (C.F.P.) designation from the Financial Planning Standards Council. He is a named inventor on 13 issued U.S. patents. We believe Dr. Tucker is qualified to serve on our Board of Directors due to his extensive experience as a chief executive officer and director of public biotechnology companies, his track record of raising over $100 million in capital, and his expertise in executing strategic transactions including initial public offerings, mergers, and acquisitions.

Corporate Governance

Our business and affairs are managed under the direction of our Board of Directors (“Board”), which currently consists of four members. The number of directors is currently determined by the Board in accordance with our certificate of incorporation and bylaws, which provide that the number of directors shall be determined exclusively by resolution adopted by a majority of the total number of authorized directors, whether or not there exist any vacancies in previously authorized directorships. Each director is elected to serve a one-year term and is to be reelected at each annual meeting of shareholders.

Our officers are appointed by the Board and serve at the discretion of the Board until they are removed or replaced in accordance with our bylaws.

When evaluating whether directors and nominees collectively possess the necessary experience, qualifications, and skills to effectively fulfill the Board’s oversight responsibilities, the Board considers each individual’s background and expertise, as outlined in their biographies. We believe our Board offers an appropriate mix of skills and experience relevant to the size and nature of our business.

Corporate Governance Profile

The structure of our corporate governance includes the following:

●

Our directors satisfy the Nasdaq listing standards for independence;

●

Generally, all matters to be voted on by stockholders are approved by a majority (or, in the case of election of directors, by a plurality) of the votes entitled to be cast by all stockholders present in person or represented by proxy, voting together as a single class;

●

We intend to comply with the requirements of the Nasdaq marketplace rules, including having committees comprised of independent directors; and

●

We currently do not have a stockholder rights plan.

Our directors stay informed about our business by attending meetings of our Board and its committees and through supplemental reports and communications. Our independent directors meet regularly in executive sessions without the presence of our corporate officers or non-independent directors.

Role of the Board in Risk Oversight

The Board actively manages the Company’s risk oversight process and receives periodic reports from management on areas of material risk to the Company, including operational, financial, legal, and regulatory risks. The Board committees will assist the Board in fulfilling its oversight responsibilities in certain areas of risk. The Audit Committee will assist the Board with its oversight of the Company’s major financial risk exposures. The Compensation Committee will assist the Board with its oversight of risks arising from the Company’s compensation policies and programs. The Corporate Governance and Nominating Committee will assist the Board with its oversight of risks associated with board organization, board independence, and corporate governance. While each committee will be responsible for evaluating certain risks and overseeing the management of those risks, the entire Board will be regularly informed about the risks.

Director Independence

The Nasdaq marketplace rules require that, subject to specified exceptions, each member of a listed company’s audit, compensation, and nominations committees be independent, or, if a listed company has no nominations committee, that director nominees be selected or recommended for the board’s selection by independent directors constituting a majority of the board’s independent directors. The Nasdaq marketplace rules further require that audit committee members satisfy independence criteria set forth in Rule 10A-3 under the Exchange Act and that compensation committee members satisfy the independence criteria set forth in Rule 10C-1 under the Exchange Act. These rules require that our Audit Committee be composed of at least three (3) members, all of whom must be independent.

Our Board undertook a review of the independence of our directors and considered whether any director has a material relationship with us that could compromise that director’s ability to exercise independent judgment in carrying out that director’s responsibilities.

Our Board has affirmatively determined that both Dr. Doug Manion, Dr. Joseph Tucker and Leonard J. DeRoma qualify as independent directors, as defined under the applicable Nasdaq corporate governance standards. Our remaining directors are currently searching for a qualified replacement and will appoint that individual in accordance with our bylaws and applicable corporate governance rules.

Board Committees and Meetings

Our Board has established the Compensation Committee, the Finance, Audit, and Risk Committee, and the Nomination and Governance Committee to assist with the performance of the Company’s responsibilities.

Finance, Audit, and Risk Committee

The Board formally established the Finance, Audit, and Risk Committee to assist in fulfilling its oversight responsibilities related to the integrity of the Company’s financial statements, financial reporting process, and systems of internal accounting and financial controls, compliance with legal and regulatory requirements, and the performance of its internal audit function and independent auditors. The Finance, Audit, and Risk Committee is composed of three (3) members, Leonard J. DeRoma, Dr. Joseph Tucker and Dr. Doug Manion, all of whom are independent directors.

Leonard J. DeRoma serves as the chair of the Finance, Audit, and Risk Committee. The primary responsibilities of the committee include:

●

Reviewing and discussing the Company’s annual and quarterly financial statements, including related disclosures and the results of the audit or review, with management and the independent registered public accounting firm;

●

Monitoring the Company’s financial reporting processes and internal control over financial reporting;

●

Overseeing the services performed by the independent registered public accounting firm, including its appointment, compensation, independence, and performance, and serving as the auditor’s direct point of contact with the Board;

●

Facilitating open communication between the independent auditor, management, and the Board;

●

Reviewing any disagreements between management and the independent auditor regarding financial reporting matters;

●

Approving all audit and permissible non-audit services performed by the independent registered public accounting firm; and

●

Establishing procedures for the receipt and handling of complaints regarding accounting, internal accounting controls, or auditing matters.

The Board has determined that each member of the Finance, Audit, and Risk Committee is independent of management and free of any relationships that, in the opinion of the Board, would interfere with the exercise of independent judgment and are independent, as that term is defined under the enhanced independence standards for audit committee members in the Exchange Act and the rules promulgated thereunder.

The Board has determined that Leonard J. DeRoma is the “financial expert” of the Finance, Audit, and Risk Committee, as that term is defined in the rules promulgated by the Securities and Exchange Commission (the “SEC”) pursuant to the Sarbanes-Oxley Act of 2012. The Board has further determined that each member of the Finance, Audit, and Risk Committee is financially literate and that at least one member of the committee has accounting or related financial management expertise, as such terms are interpreted by the Board in its business judgment.

Compensation Committee

The Board formally established a Compensation Committee to assist in fulfilling its oversight responsibilities related to the compensation of the Company’s directors, executive officers, and key employees. The Compensation Committee is composed of three (3) members: Dr. Doug Manion, Dr. Joseph Tucker and Leonard J. DeRoma. All of whom are independent directors, as defined under the general independent standards of the Nasdaq listing standards. The primary responsibilities of the committee include:

●

Establishing and overseeing compensation policies designed to attract, retain, and motivate executive officers and other key employees, while aligning with the Company’s performance and stockholders’ interests;

●

Reviewing and approving corporate goals and objectives for the Chief Executive Officer, evaluating their performance, and setting their compensation based on the evaluation;

●

Reviewing and approving compensation packages for executive officers and other key employees, including base salary, short- and long-term incentive awards, equity-based compensation, and employment or severance agreements;

●

Overseeing the administration of the Company’s incentive and equity-based compensation plans and approving grants or awards made under such plans;

●

Reviewing and making recommendations to the Board regarding compensation of non-employee directors;

●

Overseeing the process of management performance evaluations and succession planning;

●

Retaining, as needed, compensation consultants or other advisors to assist in the evaluation of compensation matters, with full authority to approve their fees and other terms, provided such expenditures are within the Company’s approved budget; and

●

Making regular reports to the Board and conducting an annual performance evaluation of the Committee.

The Compensation Committee will determine and approve all elements of executive officer compensation and will provide recommendations to the Board with respect to non-employee director compensation. The Compensation Committee may not delegate its authority to any other person, other than to a subcommittee.

Corporate Governance and Nominating Committee

Our Board formally established the Corporate Governance and Nominating Committee to assist in fulfilling its responsibilities related to the nomination and governance processes. The Corporate Governance and Nominating Committee is composed of three (3) members: Dr. Doug Manion, Dr. Joseph Tucker and Leonard J. DeRoma. Each of whom is an independent director, as defined under the general independent standards of the Nasdaq listing standards. Dr. Doug Manion, a “non-employee director” under the meaning of Rule 16b-3 of the Exchange Act, serves as the chair of the Corporate Governance and Nominating Committee. The primary responsibilities of the committee include:

●

Assisting the Board in identifying qualified candidates for director and recommending nominees for election at the annual shareholders’ meeting;

●

Leading the annual review of the Board’s performance and recommending actions to improve its effectiveness;

●

Recommending director nominees for each Board committee;

●

Overseeing the annual evaluation process of the performance of the Company’s management;

●

Developing and recommending corporate governance guidelines to the Board, including the Company’s Code of Business Conduct and Ethics;

●

Retaining and overseeing any third-party search firms to assist in identifying potential director candidates, with approval of the search firm’s fees and terms;

●

Evaluating Board member skills and qualifications to ensure the Board remains knowledgeable and diverse;

●

Considering shareholder-recommended director candidates according to the Company’s procedures for shareholder nominations;

●

Developing and monitoring compliance with corporate governance principles and recommending any changes to the Board for approval;

●

Overseeing succession planning for the Chief Executive Officer and other senior officers; and

●

Regularly assessing the relationship between the Board and management, ensuring effective communication.

Code of Business Conduct and Ethics

The Board has adopted a Code of Business Conduct that applies to all of our directors, officers, and employees, including our Chief Executive Officer and Chief Financial Officer, and should also be followed by agents and representatives. The objective of the Code of Business Conduct is to provide guidelines for maintaining our integrity, reputation, honesty, objectivity, and impartiality. The Code of Business Conduct addresses compliance with laws, conflicts of interest, insider trading, fair dealing, corporate opportunities, confidentiality, protection and proper use of company assets, political contributions, health and safety, discrimination and harassment, environmental compliance, record-keeping, payments to government personnel, trade issues, improper influence on auditors, and accurate disclosures. Those subject to the Code must avoid or disclose any situations that may lead to actual, potential, or perceived conflicts of interest. Employees are expected to report any violations or unethical behavior without fear of retaliation. Oversight of the Code is the responsibility of the Board, and directors, officers, and exempt salaried employees are required to annually acknowledge their understanding and compliance.

Clawback Policy

We have adopted a clawback policy that complies with the requirements of Rule 10D-1 under the Exchange Act and the applicable listing standards of the Nasdaq Capital Market prior to the consummation of the offering. Under this policy, in the event we are required to prepare an accounting restatement due to material noncompliance with any financial reporting requirement under the securities laws, we will recover reasonably promptly from our current and former executive officers the amount of erroneously awarded incentive-based compensation received during the three completed fiscal years preceding the date we are required to prepare the restatement.

The policy applies to incentive-based compensation that is received on or after the effective date of the applicable listing standards. We will recover erroneously awarded compensation except to the extent that our board of directors, or a committee thereof, determines that recovery would be impracticable due to certain limited exceptions permitted by Rule 10D-1 and the listing standards.

We will not indemnify any current or former executive officer against the loss of erroneously awarded compensation under the policy.

A copy of our Code of Business Conduct can be found as an exhibit to the registration statement of which this prospectus is a part. You will be able to review this document by accessing our public filings on the SEC’s website at www.sec.gov. In addition, a copy of the Code will be provided without charge upon request from us. We intend to satisfy the disclosure requirement under Item 5.05 of Form 8-K relating to amendments to or waivers from any provision of the Code applicable to our Chief Executive Officer and Chief Financial Officer by posting such information on our website. Please see “Where You Can Find Additional Information.”

Legal Proceedings

To our knowledge, other than as described in the section titled Business — Legal Proceedings in this prospectus, (i) no director or executive officer has been a director or executive officer of any business which has filed a bankruptcy petition or had a bankruptcy petition filed against it during the past ten years; (ii) no director or executive officer has been convicted of a criminal offense or is the subject of a pending criminal proceeding during the past ten years; (iii) no director or executive officer has been the subject of any order, judgment or decree of any court permanently or temporarily enjoining, barring, suspending or otherwise limiting his involvement in any type of business, securities or banking activities during the past ten years; and (iv) no director or officer has been found by a court to have violated a federal or state securities or commodities law during the past ten years.

EXECUTIVE AND DIRECTOR COMPENSATION

We are an “emerging growth company” under applicable SEC rules and are providing disclosure regarding our executive compensation arrangements pursuant to the rules applicable to emerging growth companies, which means that we are not required to provide a compensation discussion and analysis and certain other disclosures regarding our executive compensation. The following discussion relates to the compensation of our named executive officers for 2025 and 2024.

Summary Compensation Table

The following table sets forth the compensation paid by the Company to its chief executive officer and other compensated executive officers. The disclosure is provided for the years ended 2025 and 2024:

Name and Principal Position	Year		Salary $			Bonus $		Stock Options⁽¹⁾ $		Total $
Kelvin Cooper,		2025	$	190,417		$	—	$	372,960	$	563,377
CEO		2024	$	409,167		$	160,000	$	136,808	$	705,975
Peter Ceccacci,		2025	$	160,000		$	—	$	372,960	$	532,960
CFO		2024	$	290,281		$	95,000	$	56,053	$	441,334
Thomas Balzer,		2025	$	177,917		$	—	$	310,800	$	488,717
CMO		2024	$	409,167		$	160,000	$	87,060	$	656,227
Peter B. Corr		2025	$	48,000	⁽²⁾	$	—	$	—	$	48,000
Executive Chair		2024	$	48,000	⁽²⁾	$	—	$	—	$	48,000

(1)

The amounts reported in the “Stock Options” column represent the grant date fair value of the stock option awards granted during the fiscal year, calculated in accordance with FASB ASC Topic 718. The assumptions used in the valuation of these awards are described in Note 8 — Stock-Based Compensation to our financial statements included elsewhere in this prospectus. These amounts do not reflect the actual economic value that will be realized by the named executive officer upon the vesting of the stock options, the exercise of the stock options, or the sale of the common stock underlying such stock options.

(2)

Salary paid with shares of Common Stock.

Employment Agreements

The Company has entered into employment agreements with each of our named executive officers prior to the expected date of the Company’s listing on Nasdaq, including Kelvin Cooper, Peter Ceccacci, and Thomas Balzer. The material terms of these agreements are summarized below.

Dr. Kelvin Cooper has served as our Chief Executive Officer pursuant to an employment agreement dated November 1, 2021, which provided for an initial annual base salary of $260,000, subject to periodic review and adjustment by the Board or Compensation Committee. His base salary was subsequently increased to $350,000 on August 1, 2022, to $360,000 on February 1, 2023, to $390,000 on August 1, 2023 in connection with his promotion to Chief Operating Officer, and to $415,000 on March 16, 2024. Dr. Cooper was also eligible for an annual discretionary bonus, initially targeted at 20% of base salary, which was increased to 30% on August 1, 2022, and to 40% on August 1, 2023, subject to Compensation Committee approval. The agreement also provided for standard benefits, including health care and 401(k) participation, and required 30 days’ notice for termination by either party.

On July 1, 2025, Dr. Cooper entered into a new employment agreement, which provides for an annual base salary of $245,000 until the closing of at least $5 million in financing through a private placement and $490,000 thereafter, subject to periodic review and adjustment. He is also eligible for an annual discretionary bonus targeted at 45% of base salary, subject to Board approval. In connection with this agreement, Dr. Cooper received a grant of 202,703 stock options on July 2, 2025, with an exercise price of $0.39 per share, which vested immediately. The agreement also provides for severance benefits in the event of a termination without cause or resignation for good reason, including 6 months of base salary, a bonus equal to 50% of the prior year’s bonus (or 22.5% of base salary if no prior bonus), accelerated vesting of equity awards, and continued exercisability for the remainder of the 10-year term. In the event of a termination in connection with a change in control, Dr. Cooper is entitled to 18 months of base salary and a bonus equal to 45% of base salary for the first year and 22.5% for the second half-year, based on the salary in effect at the time of the change in control.

Mr. Peter Ceccacci has served as our Chief Financial Officer pursuant to an employment agreement dated March 1, 2021, which provided for an initial annual base salary of $200,000, subject to periodic review and adjustment by the Board or Compensation Committee. His base salary was increased to $240,000 on August 1, 2021, to $267,000 on August 1, 2022, to $275,000 on February 1, 2023, and to $305,000 on March 16, 2024. Mr. Ceccacci was also eligible to receive an annual discretionary bonus targeted at 30% of base salary, subject to Compensation Committee approval. The agreement also provided for standard employee benefits, including health care and participation in a noncontributory 401(k) plan, and required 90 days’ notice for termination by either party.

On July 1, 2025, Mr. Ceccacci entered into a new employment agreement, which provides for an annual base salary of $202,500 until the closing of at least $5 million in financing through a private placement and $405,000 thereafter, subject to periodic review and adjustment. He is also eligible to receive an annual discretionary bonus targeted at 35% of base salary, subject to Board approval. In connection with this agreement, on July 2, 2025, Mr. Ceccacci received a grant of 202,703 stock options with an exercise price of $0.39 per share, which vested immediately. Details regarding his equity awards are included in the Outstanding Equity Awards Table below. The July 2025 agreement also provides for severance benefits in the event of a termination without cause or resignation for good reason, including 6 months of base salary in effect at the time of termination, a bonus equal to 50% of the prior year’s bonus (or 17.5% of base salary if no prior bonus was received), accelerated vesting of equity awards, continued exercisability for the remainder of the 10-year term, and continued benefits during the severance period. In the event of a termination in connection with a change in control, Mr. Ceccacci is entitled to 18 months of base salary and a bonus equal to 35% of base salary for the first 12 months and 17.5% for the final 6 months, based on the salary in effect at the time of the change in control.

Dr. Thomas Balzer has served as our Chief Medical Officer pursuant to an employment agreement dated November 14, 2022, which provided for an initial annual base salary of $350,000, subject to periodic review and adjustment by the Board or Compensation Committee. His base salary was increased to $360,000 on February 1, 2023, to $390,000 on August 1, 2023 in connection with his promotion to Chief Medical Officer, and to $415,000 on March 16, 2024. Dr. Blazer was also eligible to receive an annual discretionary bonus targeted at 30% of base salary, which was increased to 40% on August 1, 2023, subject to Compensation Committee approval. The agreement also provided for standard employee benefits, including health care and participation in a noncontributory 401(k) plan, and required 30 days’ notice for termination by either party.

On July 1, 2025, Dr. Balzer entered into a new employment agreement providing for an annual base salary of $220,000 until the closing of at least $5 million in financing through a private placement and $440,000 thereafter, subject to periodic review and adjustment. He is also eligible to receive an annual discretionary bonus targeted at 40% of base salary, subject to Board approval. In connection with this agreement, on July 2, 2025, Dr. Balzer received a grant of 168,919 stock options with an exercise price of $0.39 per share, which vested immediately. Details regarding his equity awards are included in the Outstanding Equity Awards Table below. The July 2025 agreement provides for severance benefits in the event of a termination without cause or resignation for good reason, including 6 months of base salary in effect at the time of termination, a bonus equal to 50% of the prior year’s bonus (or 20% of base salary if no bonus was received), accelerated vesting of equity awards, continued exercisability for the remainder of the 10-year term, and continuation of employee benefits during the severance period. In the event of a termination in connection with a change in control, Dr. Balzer is entitled to 18 months of base salary and a bonus equal to 40% of base salary for the first 12 months and 20% for the final 6 months, based on the salary in effect at the time of the change in control.

Stock Equity Incentive Plan

2020 Equity Incentive Plan

On November 30, 2020, the Board adopted the 2020 Equity Incentive Plan (the “Plan”). Below is a summary of the Plan, which is qualified in its entirety by the full text of the 2020 Plan, attached hereto as Exhibit 10.1 to the registration statement on Form S-1 of which this prospectus is a part, incorporated herein by reference.

We have adopted the Plan to enable us and our affiliates to recruit and retain highly qualified personnel, provide employees, directors, and consultants with an incentive for productivity, and offer such individuals an opportunity to share in the growth the value of our company. The Plan is administered by the Board, although the Board may delegate some or all of its administrative authority to a committee. Subject to the terms of the Plan, the Board has broad authority to determine eligible participants, grant awards, establish award terms and conditions, adopt administrative rules, and interpret and construe the Plan and any award agreements.

The maximum aggregate number of shares of our common stock that may be issued under the Plan is 1,834,958 shares. If an award expires, terminates, or is canceled or forfeited without having been exercised in full, or if any restricted stock is forfeited or repurchased, or shares are withheld for tax or exercise purposes, such shares will again be available for grant under the Plan. In the event of any recapitalization, stock split, stock dividend, or similar event affecting our capital structure, or in the event of a change of control, the Board may make equitable adjustments to the number and type of shares available under the Plan and outstanding awards, in its discretion.

Awards under the Plan may be granted in the form of incentive stock options or non-qualified stock options, and restricted stock. The exercise price of any stock option granted will not be less than the fair market value of the common stock on the date of grant, or 110% of the fair market value for incentive stock options granted to 10% stockholders. The term of any stock option may not exceed ten years from the date of grant, or five years in the case of incentive stock options granted to 10% stockholders. Options will be vast and exercisable according to the schedule and conditions set forth by the Board. They are generally non-transferable except by will or by the laws of descent and distribution.

Restricted stock awards are subject to restrictions and conditions determined by the Board. During the restriction period, the holder may not sell, assign, pledge, or otherwise transfer the restricted stock. The Board may condition vesting on continued service, attainment of specified performance goals, or other factors. Unless otherwise provided, holders of restricted stock generally have voting and dividend rights, and any dividends paid in the form of securities will be subject to the same restrictions. If the holder’s service terminates before vesting, the unvested shares will generally be forfeited.

Upon termination of service, the treatment of options depends on the circumstances. In the event of death or disability, options may be exercised within 12 months or a shorter period specified by the Board. If terminated for cause, all options (whether or not vested) are immediately forfeited, and previously acquired shares may be subject to repurchase. For other terminations, options may be exercised within 90 days from the date of such termination of service unless otherwise specified. The Board may also cancel awards or seek repayment of gains if a participant has engaged in any detrimental activity, or if a participant receives excess amounts due to financial restatement, miscalculation, or administrative error.

The Board may amend, alter, or discontinue the Plan at any time, subject to stockholder approval if required under applicable law. The Plan provides that no incentive stock options may be granted after the tenth anniversary of the date of Board approval of the Plan (i.e., after November 30, 2030), although awards granted prior to such anniversary may extend beyond such date. The Plan is governed by the laws of the State of Delaware and intended to comply with Sections 409A and Section 422 of the Internal Revenue Code.

Outstanding Equity Awards

The following table sets forth information about the outstanding equity awards held by each of our named executive officers as of December 31, 2025:

Option Awards⁽¹⁾
Name	Grant Date	Number of securities underlying unexercised options (#) exercisable		Number of securities underlying unexercised options (#) unexercisable		Equity incentive plan awards: number of securities underlying unexercised unearned options (#)		Option exercise price ($)		Option expiration date
Kelvin Cooper	7/12/2021¹		10,136		—		—	$	2.78	7/11/2031
	11/1/2021²		13,514		—		—	$	2.78	10/31/2031
	3/2/2023³		25,338		25,338		25,338	$	2.13	3/1/2033
	3/14/2024¹⁰		36,234		36,233		36,233	$	2.13	3/28/2034
	7/2/2025¹¹		202,703		—		—	$	2.31	7/1/2035

Peter Ceccacci	3/1/2021⁴		33,784		—		—	$	2.78	3/1/2031
	3/2/2023⁹		67,568		—		—	$	2.13	3/1/2033
	3/2/2023⁵		25,338		25,338		25,338	$	2.13	3/1/2023
	3/14/2024⁶		7,390		22,171		22,171	$	2.13	3/13/2034
	7/2/2025¹¹		202,703		—		—	$	2.31	7/1/2035

100

Option Awards⁽¹⁾
Name	Grant Date	Number of securities underlying unexercised options (#) exercisable		Number of securities underlying unexercised options (#) unexercisable		Equity incentive plan awards: number of securities underlying unexercised unearned options (#)		Option exercise price ($)		Option expiration date
Thomas Balzer	11/14/2022⁷		38,007		12,669		12,669	$	2.13	11/13/2032
	3/2/2023⁸		16,892		16,892		16,892	$	2.13	3/1/2033
	3/14/2024¹⁰		23,058		23,057		23,057	$	2.13	3/13/2023
	7/2/2025¹¹		168,919		—		—	$	2.31	7/1/2035

(1)

Unless otherwise noted below as an exception, the stock options listed in this table vest over a four-year period, with 25% of the shares vesting on each anniversary of the grant date, subject to the reporting person’s continued service through each vesting date. The specific vesting commencement dates and schedules for each award are as follows:

Option granted on July 12, 2021: 25% vests on each of the first four anniversaries of July 12, 2021, beginning on July 12, 2022 and ending on July 12, 2025.

Option granted on November 1, 2021: 25% vests on each of the first four anniversaries of November 1, 2021, beginning on November 1, 2022 and ending on November 1, 2025.

Option granted on March 2, 2023: 25% vests on each of the first four anniversaries of March 2, 2023, beginning on March 2, 2024 and ending on March 2, 2027.

Option granted on March 1, 2021: 25% vests on each of the first four anniversaries of March 1, 2021, beginning on March 1, 2022 and ending on March 2, 2025.

Option granted on March 2, 2023: 25% vests on each of the first four anniversaries of March 2, 2023, beginning on March 2, 2024 and ending on March 2, 2027.

Option granted on March 14, 2024: 25% vests on each of the first four anniversaries of March 14, 2024, beginning on March 14, 2025 and ending on March 2, 2028.

Option granted on November 14, 2022: 25% vests on each of the first four anniversaries of November 14, 2022, beginning on November 14, 2023 and ending on November 14, 2026.

Option granted on March 2, 2023: 25% vests on each of the first four anniversaries of March 2, 2023, beginning on March 2, 2024 and ending on March 2, 2027.

Exceptions:

Option granted on March 2, 2023: 37,162 shares vested on the grant date and 30,406 shares vested on January 1, 2024, subject to the reporting person’s continued service through each vesting date.

Option granted on March 14, 2024: 25% vests on each of the first four anniversaries of August 1, 2023, beginning on August 1, 2024 and ending on August 1, 2027.

Options granted on July 2, 2025: all shares vested on grant date.

101

Director Compensation

The following table sets forth the compensation paid by the Company to its directors with common stock in lieu of cash. The disclosure is provided for the years ended 2025 and 2024:

Name	Year	Fees Paid in cash ($)		Option Awards ($)		All Other Compensation ($)		Total ($)
Doug Manion	2025	$	24,000	$	—	$	—	$	24,000
	2024	$	24,000	$	—	$	—	$	24,000

Leonard DeRoma	2025	$	24,000	$	—	$	—	$	24,000
	2024	$	24,000	$	—	$	—	$	24,000

Charles Wright⁽²⁾	2025	$	24,000	$	—	$	—	$	24,000
	2024	$	24,000	$	—	$	—	$	24,000

(2)

Charles F. Wright previously served as an independent director but passed away suddenly on December 21, 2025, and was replaced by the recent appointment of Dr. Tucker on April 24, 2026. Accordingly, Dr. Tucker did not receive any compensation in 2025 or 2024.

In connection with their service on the Board of the Company, each non-employee director is compensated pursuant to terms set forth in individual director agreements. The following is a description of the material components of such compensation, consistent with Item 402(r)(3) of Regulation S-K:

Cash Compensation

Each non-employee director receives a quarterly board fee of $6,000, payable in shares of the Company’s common stock. The Chair of the Board receives a quarterly board fee of $12,000, also payable in common stock. These fees are effective as of the date of each director’s agreement with the Company.

Equity Compensation

Upon appointment, each new director is granted 33,784 warrants to purchase shares of the Company’s common stock at an exercise price equal to the prior year-end 409A valuation of the Company’s common stock. These warrants have a ten-year exercise term and vest in four equal installments of 8,446 warrants on each six-month anniversary of the grant date, until fully vested over a two-year period. Unvested warrants are forfeited if a director’s service ends prior to full vesting.

Board Member Duties and Other Terms

Non-employee directors are expected to attend up to four, but no fewer than two, formal Board meetings per year and to be available for ad hoc consultations as needed. Directors also agree to allow the Company to use their name and biographical information in Company press releases and on the Company website in connection with their role as Board members.

The Company reimburses non-employee directors for reasonable and pre-approved travel and lodging expenses incurred in connection with attending Board meetings or other Company-related activities. This service arrangement continues indefinitely unless and until terminated by either the director or the Company, in accordance with the applicable agreement.

102

Termination Provisions

Director agreements continue until terminated by either the director or the Company. Upon termination of service:

●

The director is entitled to any fees earned through the date of termination;

●

Any reasonable expenses incurred prior to termination will be reimbursed;

●

Any unvested warrants are forfeited; and

●

The Company has no further obligation for compensation or reimbursement following termination.

Director Independence

All non-employee directors are considered non-executive and are not employees of the Company. Directors are not eligible for employee benefit plans and are not authorized to enter into contracts or make binding commitments on behalf of the Company. Each director acts independently and is not subject to day-to-day control by the Company.

The following table sets forth information about the outstanding equity awards held by each of our named directors as of December 31, 2025:

Option and Warrant Awards
Name	Grant Date	Number of securities underlying unexercised warrants (#) exercisable		Number of securities underlying unexercised warrants (#) unexercisable		Equity incentive plan awards: number of securities underlying unexercised unearned options (#)		Warrant exercise price		Warrant expiration date
Doug Manion	7/1/2021		33,784		—		—	$	2.78	6/30/2031

Leonard DeRoma	3/31/2016		40,541		—		—	$	5.92	3/30/2028
	3/1/2017		13,514		—		—	$	5.92	2/28/2028
	7/12/2017		33,784		—		—	$	5.92	7/11/2028
	7/12/2020		8,446		—		—	$	2.37	7/11/2030
	7/12/2021		8,446		—		—	$	2.78	7/11/2031
	7/12/2022		8,446		—		—	$	2.13	7/11/2032

Charles Wright⁽²⁾	1/1/2019		33,784		—		—	$	2.90	12/31/2028
	1/1/2022		8,446		—		—	$	2.13	12/31/2031
	1/2/2023		8,446		—		—	$	2.13	1/1/2032

(2)

103

CERTAIN RELATIONSHIPS AND RELATED PERSON TRANSACTIONS

The following describes transactions since January 1, 2022, and currently proposed transactions, to which the Company has been a party and in which the amount involved exceeded or is expected to exceed $120,000, and in which any of the Company’s directors, executive officers, or beneficial owners of more than 5% of the Company’s common stock, or their immediate family members or affiliated entities, had or will have a direct or indirect material interest. The Company believes that the terms and conditions of these transactions were reasonable and consistent with market terms for transactions of this nature.

Related Party Notes Payable (2026)

The Notes contained customary events of default, including (i) failure to make required payments when due (subject to specified cure periods), (ii) failure to perform material covenants, and (iii) insolvency-related events. Upon the occurrence of an event of default, the applicable lender could declare all outstanding obligations immediately due and payable. The Notes also provided for the payment of reasonable costs of collection and enforcement, including attorneys’ fees. The Notes were unsecured obligations of the Company and were governed by the laws of the State of Florida.

During April 2026, the Company repaid in full all outstanding principal and accrued interest under the Notes, and no amounts remain outstanding thereunder.

Related Party Notes Payable (2025)

On March 7, 2025, the Company received proceeds of $200,000 pursuant to a short-term promissory note issued by a board member. An additional promissory note in the principal amount of $50,000 was issued by another board member on April 7, 2025. In May 2025, both notes were amended to conform to the terms of the Company’s $1.25 million convertible note financing, resulting in an aggregate principal amount of $1.5 million of convertible notes outstanding.

Pursuant to the amended terms, the outstanding principal and accrued interest on these notes automatically converted into 205,921 shares of the Company’s common stock at a conversion price of $8.00 per share in connection with the Company’s listing on Nasdaq Capital Market on April 23, 2026. Following such conversion, no amounts remain outstanding under these notes.

104

Related parties include Directors, Officers, and Beneficial Owners of more than 5% of any class of stock. The related parties included in the $1.5 million convertible notes are as follows:

Related parties include the Company’s directors, executive officers, and beneficial owners of more than 5% of common stock of the Company. The related parties participating in the $1.5 million convertible notes are as follows:

Name	Relationship	Amount
Doug Manion, M.D.	Chairman of the Board	$	50,000
Leonard J. DeRoma	Board Member	$	5,000
Peter Ceccacci	Chief Financial Officer	$	25,000
Charles F. Wright	Former Board Member (see footnote (2) on page 111)	$	300,000

Related Party Notes Payable (2022-2024)

As of December 31, 2023, the Company owed $200,000 in principal and $138,020 in accrued interest to Lindesfarne LLC, a related party. Lindesfarne LLC is the Company’s second largest stockholder and is 80% owned by two trusts established for the benefit of the children of the Company’s founder, the late Dr. Roderic Dale. The trustee of these trusts is Ms. Gay Walker, the widow of Dr. Dale. The remaining 20% of Lindesfarne is owned by Mr. Steve Parkinson, the Company’s former CEO and a former director.

On June 28, 2024, these notes payable were converted into 56,307 shares of the Company’s common stock, and the accrued interest of $143,020 was forgiven by Lindesfarne LLC, resulting in a capital contribution to the Company.

105

PRINCIPAL STOCKHOLDERS

Security Ownership of Certain Beneficial Owners and Management

The following table sets forth information regarding the beneficial ownership of our Common Stock, and Series C Preferred Stock as of April 23, 2026 by (a) each stockholder who is known to us to own beneficially 5% or more of the Company’s respective stock; (b) all directors; (c) our executive officers, and (d) all executive officers and directors as a group. Except as otherwise indicated, all persons listed below have (i) sole voting power and investment power with respect to their stock, except to the extent that authority is shared by spouses under applicable law, and (ii) record and beneficial ownership with respect to their stock.

To calculate a specific stockholder’s percentage of beneficial ownership, we include in that stockholder’s calculation those shares underlying options or warrants beneficially owned by that stockholder that are vested or that will vest within 60 days of April 23, 2026. Options or warrants held by other stockholders that are not attributed to the named beneficial owner are disregarded in this calculation. As of April 23, 2026, the Company had 14,368,227 shares of Common Stock issued and 14,320,366 shares outstanding, and 937,500 shares of Series C Preferred Stock issued and outstanding.

Name of Beneficial Owner	Total Common Stock Shares Beneficially Owned		Vested Options/ Warrants		% of Common Stock Beneficially Owned			Total Series C Shares Beneficially Owned^(a)		% of Series C Stock Owned
Named Executive Officers
Kelvin Cooper Ph.D.		0		300,594		2.06	%		0		0	%
Peter Ceccacci		111,326		356,843		3.19	%		0		0	%
Thomas Balzer		0		255,322		1.75	%		0		0	%
Named Directors
Doug Manion MD		51,801		33,784		0.60	%		0		0	%
Leonard J. DeRoma		74,559		113,177		1.30	%		0		0	%
Joseph Tucker		0		0		0.00	%		0		0	%
All executive officers and directors as a group (6 persons)		237,686		1,059,720		8.44	%		0		0	%

5% Stockholders^(b)
HPW Investments Holdings Ltd^(c)		3,435,501		0		23.99	%		0		0	%
Lindesfarne LLC^(d)		2,033,596		0		14.20	%		0		0	%
WFI Equity, LLC^(e)		1,259,684		0		8.80	%		0		0	%
Shakawe Capital LLC^(f)		0		0		0.00	%		937,500		100	%
TLP Management Inc.^(g)		779,496		0		5.44	%		0		0	%
Dr. Ted Brown Jr.^(h)		775,451		0		5.42	%		0		0	%
Total 5% owners		8,283,728		0		57.85	%		937,500		100	%
Total of D&O + 5% Owners		8,521,414		1,059,720		62.30	%		937,500		100	%
Other Beneficial Stockholders
Other Beneficial Stockholders		5,798,952		335,735		41.86	%		0		0	%
Overall Totals		14,320,366		1,395,455		100.00	%		937,500		100	%

(a)	Series C Preferred Shares before conversion to Common Stock

(b)	The entries represent Shareholders with > 5% ownership of their respective class of shares.

(c)	The shares of HPW Investment Holdings are managed by Thomas Kaufmann. The principal business address of HPW Investments Holdings Ltd is PO Box 264, IFC 5, St. Helier, Jersey, JE1, Bailiwick of Jersey.

(d)	The shares of Lindesfarne are managed by Michael Pirooz. The principal address of Lindesfarne is 1409 7^th Ave., Greeley, CO 80631.

(e)	The shares of WFI Equity LLC are managed by Royal Caswell. The principal business address of WFI Equity, LLC is 320 N. Main Street, Suite 200, Ann Arbor, MI 48104.

(f)	The shares of Shakawe Capital LLC are managed by Dimitriy Shapiro. The principal address of Shakawe Capital LLC is 144 Hillside Village, Rio Grande, PR 00745.

(g)	Includes the shares of TLP Investment Partners LLC, Sunshine Charitable Foundation, and Lake Street Capital Fund I LLC, all of which are both managed by Dave Bunning at TLP Management Inc. The principal address of TLP Management Inc. is 1603 Orrington Ave., Ste 450, Evanston, IL 60201.

(h)	Includes the shares owned by Advanta IRA Services LLC FBO Ted Brown Jr., Desiree Brown, Dr Ted Brown Jr & Mrs. Desiree D. Brown, and Dr Ted Brown Jr.

106

DESCRIPTION OF CAPITAL STOCK

The following descriptions are summaries of the material terms of our certificate of incorporation and bylaws. Reference is made to the more detailed provisions of, and the descriptions are qualified in their entirety by reference to, the certificate of incorporation and bylaws, forms of which are filed with the SEC as exhibits to the registration statement of which this prospectus is a part, and applicable law.

Our authorized capital stock consisted of 186,437,500 shares, comprising:

●

125,000,000 shares of Common Stock, par value $0.0001 per share (the “Common Stock”);

●

8,000,000 shares of Series A Convertible Preferred Stock, par value $0.0001 per share (the “Series A Preferred Stock”); and

●

52,500,000 shares of Series B Convertible Preferred Stock, par value $0.0001 per share (the “Series B Preferred Stock”).

●

937,500 shares of Series C Convertible Preferred Stock, par value $0.0001 per share (the “Series C Preferred Stock”).

The rights and preferences of our capital stock are governed by the Certificate of Incorporation and applicable State of Nevada law. The following summarizes the material terms of each class of our capital stock. This summary is qualified in its entirety by reference to our certificate of incorporation and bylaws.

Common Stock

As of April 23, 2026, there were 14,368,227 shares of Common Stock issued and 14,320,366 shares outstanding.

Voting Rights

Holders of Common Stock are entitled to one vote per share on all matters submitted to a vote of stockholders. Common stockholders do not have cumulative voting rights. Any increase or decrease in the authorized number of shares of Common Stock (but not below the number of shares then outstanding) may be approved by the holders of a majority of the voting power of all outstanding shares of capital stock entitled to vote.

Dividend Rights

Dividends may be declared and paid when, as, and if determined by our Board, subject to the rights of preferred stockholders. No dividends may be paid on the Common Stock unless the holders of Preferred Stock receive any dividends to which they are then entitled.

Liquidation Rights

Upon liquidation, dissolution, or winding up, after payment of all debts and liabilities and satisfaction of the liquidation preferences of our Preferred Stock, the remaining assets legally available for distribution will be distributed pro rata to holders of Common Stock.

Other Rights

The Common Stock has no preemptive rights, subscription rights, conversion rights, or redemption rights.

Preferred Stock

Our certificate of incorporation authorizes 61,437,500 shares of Preferred Stock, designated as follows:

●

Series A Preferred Stock: 8,000,000 authorized shares

●

Series B Preferred Stock: 52,500,000 authorized shares

●

Series C Preferred Stock: 937,500 authorized shares

Preferred Stock may be issued in series, with rights and preferences as determined by our Board. The Series C Preferred Stock ranks senior to all of the Series B Preferred Stock, the Series A Preferred Stock, and the Common Stock in terms of liquidation preference and dividend rights.

107

Series C Preferred Shares

We have 937,500 issued and outstanding shares of Series C Preferred Stock, with the following terms.

The Series C Preferred Shares has a stated value of $10.00 per share and is convertible into Common Stock in an amount determined by the stated value divided by the conversion price.

The conversion price is equal to the lower of (i) $10.00 (the “Fixed Price”), or (ii) 80% of the lowest closing sale price of the Common Shares during the five consecutive trading days immediately preceding the conversion date or other date of determination (the “Variable Price”), but which Variable Price will not be lower than the floor price of $1.00 (the “Floor Price”). The conversion price is subject to certain adjustments, including if we sell Common Stock at a price lower than the Fixed Price, and in the event of stock splits, stock dividends, and similar transactions (provided that the Floor Price will not exceed $1.00). The Series C Preferred Shares cannot be converted to Common Stock to the extent such conversion would cause the holder to beneficially own more than 4.99% of our outstanding Common Stock.

Holders of Series C Preferred Shares are entitled to receive, when, as and if declared by the Board, out of funds of the Company legally available therefor, monthly dividends, at the rate of $0.96 per share per year, or 9.6% of the Fixed Price of $10.00 per share, which dividends will be cumulative, and payable in cash or in kind, commencing 6 months after the date that the Common Stock commenced trading on Nasdaq.

Holders of Series C Preferred Shares do not have voting rights except as required by law and except that the Company may not amend its articles in a manner adverse to the rights of the holders of the Series C Preferred Shares.

In the event of any liquidation of the Company or any Deemed Liquidation Event (as defined in the articles), holders of Series C Preferred Shares are entitled to an amount per share equal to the greater of (a) the stated value; or (b) such amount per share as would have been payable had all Series C Preferred Shares been converted into Common Shares immediately prior to such event, prior to any payment with respect to the Common Shares.

Warrants

As of April 24, 2026, we had outstanding warrants to purchase an aggregate of 300,683 shares of Common Stock. These warrants have an exercise price ranging from $2.13 to $10.00 per share and expiring between January 30, 2028, and April 23, 2036. These warrants do not entitle holders to voting rights or dividends prior to exercise. The shares issuable upon exercise are included in this registration statement.

108

Reverse Stock Split

On September 29, 2025, the Company filed a Certificate of Amendment to its Articles of Incorporation with the State of Nevada, pursuant to NRS 78.385 and 78.390, to effect a reverse stock split of its issued and outstanding shares of Common Stock at a ratio of 1-for-5.92 (the “Reverse Stock Split”).

This corporate action was approved by the Board and subsequently by the stockholders holding 60.85% of the voting power of the Company’s outstanding capital stock, in accordance with applicable law and the Company’s Articles of Incorporation.

As a result of the Reverse Stock Split:

●

Every 5.92 shares of the Company’s issued and outstanding Common Stock were automatically combined into one (1) share of Common Stock.

●

The Reverse Stock Split did not change the number of authorized shares of Common Stock or Preferred Stock, but it did update the authorized capital stock structure as reflected in the amended Articles.

●

Proportional adjustments were made to the conversion and/or exercise prices of the Company’s outstanding warrants, options, and convertible securities, as applicable.

●

No fractional shares were issued in connection with the Reverse Stock Split. Any fractional shares resulting from the split were rounded up to the nearest whole share.

The purpose of the Reverse Stock Split was to increase the per-share market price of the Company’s Common Stock in order to satisfy applicable listing requirements of national stock exchanges and to enhance the Company’s capital structure for future growth and financing activities.

Listing

Our common stock is listed on the Nasdaq Capital Market under the symbol “LABT.”

Transfer Agent and Registrar

The transfer agent and registrar for our Common Stock is ClearTrust, LLC, 16540 Pointe Village Drive, Suite 210 Lutz, Florida 33558, Phone: 813.235.4490.

109

SELLING STOCKHOLDERS

The shares of Common Stock being offered by the Investor Selling Stockholder are those issuable to the Investor Selling Stockholder, upon the conversion of the shares of Series C Preferred Stock purchased in the January 2026 private placement. The shares of Common Stock being offered by RBW, are those shares issued by the Company as partial consideration pursuant to an advisory agreement the Company entered into with RBW dated February 10, 2025, as amended. We are registering the shares of Common Stock in order to permit the Selling Stockholders to offer the shares for resale from time to time. Except for the purchase and ownership of the shares of the Series C Preferred Stock, and pursuant to the advisory agreement, respectively, the Selling Stockholders have not had any material relationship with us within the past three years.

The table below lists the Selling Stockholders and other information regarding the beneficial ownership of the shares of Common Stock by each Selling Stockholder. The first column lists the number of shares of Common Stock beneficially owned by each Selling Stockholder, based on its ownership of the shares of Common Stock and Series C Preferred Stock, respectively, as of April 23, 2026, and as to the Investor Selling Stockholder assuming conversion of the Series C Preferred Stock held by the Investor Selling Stockholder on that date, without regard to any limitations on exercises.

The second column lists the shares of Common Stock being offered by this prospectus by the Selling Stockholders

In accordance with the terms of a registration rights agreement with the Investor Selling Stockholder, this prospectus generally covers the resale of the maximum number of shares of Common Stock issuable upon conversion of the related Series C Preferred Stock, determined as if the outstanding Series C Preferred Stock were converted in full as of the trading day immediately preceding the date this registration statement was initially filed with the Commission, each as of the trading day immediately preceding the applicable date of determination and all subject to adjustment as provided in the registration right agreement. The third and fourth columns assume the sale of all of the shares offered by the Selling Stockholders pursuant to this prospectus.

Under the terms of the Series C Preferred Stock, the Investor Selling Stockholder may not convert the preferred stock to the extent such conversion would cause such selling shareholder, together with its affiliates and attribution parties, to beneficially own a number of shares of Common Stock which would exceed 4.99% or 9.99%, as applicable, of our then outstanding shares of Common Stock following such exercise, excluding for purposes of such determination shares of Common Stock issuable upon conversion of such preferred stock which have not been exercised. The number of shares in the second, third and fourth columns does not reflect this limitation. The Selling Stockholders may sell all, some, or none of their shares in this offering. See “Plan of Distribution.”

Name of Selling Shareholder	Number of shares of Common Stock Owned Prior to Offering		Maximum Number of shares of Common Stock to be Sold Pursuant to this Prospectus		Number of shares of Common Stock Owned After Offering (1)		Percent of Shares of Common Stock Beneficially Owned After this Offering (1)
Shakawe Capital LLC (2)		9,375,000		9,375,000		0	0	%
RBW Capital Partners LLC (3)		272,726		272,726		0	0	%
TOTAL		9,647,726		9,647,726		0	0	%

(1)

Assumes that the Selling Stockholders sell all of the shares of Common Stock offered pursuant to this prospectus.

(2)

Dimitriy Shapiro is the Managing Member of Shakawe Capital LLC and has voting and dispositive authority over the shares. The address of Shakawe Capital LLC is 144 Hillside Village, Rio Grande, PR 00745.

(3)

Philip Gaucher is the Managing Partner of RBW Capital Partners LLC and has voting and dispositive authority over the shares. The address of RBW Capital Partners LLC is 101 North Federal Highway, Suite 600, Boca Raton, Florida 33432.

110

PLAN OF DISTRIBUTION

We are registering the shares of common stock issued to the Investor Selling Stockholder and issuable upon exercise or exchange of the Series C Preferred Stock purchases in the January 2026 private placement, and the shares of common stock issued to RBW pursuant to the Advisory Agreement, respectively, to permit the resale of these shares of common stock by the holders of these shares of common stock from time to time after the date of this prospectus. We will not receive any of the proceeds from the sale by the Selling Stockholders of the shares of common stock. We will bear all fees and expenses incident to our obligation to register the shares of common stock.

The Selling Stockholders may sell all or a portion of the shares of common stock held by them and offered hereby from time to time directly or through one or more underwriters, broker-dealers, or agents. If the shares of common stock are sold through underwriters or broker-dealers, the Selling Stockholders will be responsible for underwriting discounts or commissions or agents’ commissions. The shares of common stock may be sold in one or more transactions at fixed prices, at prevailing market prices at the time of the sale, at varying prices determined at the time of sale, or at negotiated prices. These sales may be effected in transactions, which may involve crosses or block transactions, pursuant to one or more of the following methods:

●

on any national securities exchange or quotation service on which the securities may be listed or quoted at the time of sale;

●

in the over-the-counter market;

●

in transactions otherwise than on these exchanges or systems or in the over-the-counter market;

●

through the writing or settlement of options, whether such options are listed on an options exchange or otherwise;

●

ordinary brokerage transactions and transactions in which the broker-dealer solicits purchasers;

●

block trades in which the broker-dealer will attempt to sell the shares as agent but may position and resell a portion of the block as principal to facilitate the transaction;

●

purchases by a broker-dealer as principal and resale by the broker-dealer for its account;

●

an exchange distribution in accordance with the rules of the applicable exchange;

●

privately negotiated transactions;

●

short sales made after the date the Registration Statement is declared effective by the SEC;

●

broker-dealers may agree with a selling securityholder to sell a specified number of such shares at a stipulated price per share;

●

a combination of any such methods of sale; and

●

any other method permitted pursuant to applicable law.

The Selling Stockholders may also sell shares of common stock under Rule 144 promulgated under the Securities Act of 1933, as amended, if available, rather than under this prospectus. In addition, the Selling Stockholders may transfer the shares of common stock by other means not described in this prospectus. If a Selling Stockholder effects such transactions by selling shares of common stock to or through underwriters, broker-dealers or agents, such underwriters, broker-dealers or agents may receive commissions in the form of discounts, concessions or commissions from the selling shareholder or commissions from purchasers of the shares of common stock for whom they may act as agent or to whom they may sell as principal (which discounts, concessions or commissions as to particular underwriters, broker-dealers or agents may be in excess of those customary in the types of transactions involved). The Selling Stockholders may also loan or pledge shares of common stock to broker-dealers that, in turn, may sell such shares.

111

The Selling Stockholders may pledge or grant a security interest in some or all of the shares of common stock owned by them and, if the selling shareholder defaults in the performance of their secured obligations, the pledgees or secured parties may offer and sell the shares of common stock from time to time pursuant to this prospectus or any amendment to this prospectus under Rule 424(b)(3) or other applicable provision of the Securities Act amending, if necessary, the list of selling stockholders to include the pledgee, transferee or other successors in interest as Selling Stockholders under this prospectus. The Selling Stockholders also may transfer and donate the shares of common stock in other circumstances, in which case the transferees, donees, pledgees, or other successors in interest will be the selling beneficial owners for purposes of this prospectus.

To the extent required by the Securities Act and the rules and regulations thereunder, the Selling Stockholders and any broker-dealer participating in the distribution of the shares of common stock may be deemed to be “underwriters” within the meaning of the Securities Act, and any commission paid, or any discounts or concessions allowed to, any such broker-dealer may be deemed to be underwriting commissions or discounts under the Securities Act. At the time a particular offering of the shares of common stock is made, a prospectus supplement, if required, will be distributed, which will set forth the aggregate amount of shares of common stock being offered and the terms of the offering, including the name or names of any broker-dealers or agents, any discounts, commissions and other terms constituting compensation from the selling shareholder and any discounts, commissions or concessions allowed or re-allowed or paid to broker-dealers.

Under the securities laws of some states, the shares of common stock may be sold in such states only through registered or licensed brokers or dealers. In addition, in some states, the shares of common stock may not be sold unless such shares have been registered or qualified for sale in such state or an exemption from registration or qualification is available and is complied with.

There can be no assurance that the Selling Stockholders will sell any or all of the shares of common stock registered pursuant to the registration statement, of which this prospectus forms a part.

The Selling Stockholders and any other person participating in such distribution will be subject to applicable provisions of the Securities Exchange Act of 1934, as amended, and the rules and regulations thereunder, including, without limitation, to the extent applicable, Regulation M of the Exchange Act, which may limit the timing of purchases and sales of any of the shares of common stock by the Selling Stockholders and any other participating person. To the extent applicable, Regulation M may also restrict the ability of any person engaged in the distribution of the shares of common stock to engage in market-making activities with respect to the shares of common stock. All of the foregoing may affect the marketability of the shares of common stock and the ability of any person or entity to engage in market-making activities with respect to the shares of common stock.

We will pay all expenses of the registration of the shares of common stock pursuant to the registration rights agreement, estimated to be $ 50,000 in total, including, without limitation, Securities and Exchange Commission filing fees and expenses of compliance with state securities or “blue sky” laws; provided, however, the Selling Stockholders will pay all underwriting discounts and selling commissions, if any. We will indemnify the Investor Selling Stockholder against liabilities, including some liabilities under the Securities Act, in accordance with the registration rights agreements, or the Investor Selling Stockholder will be entitled to contribution. We may be indemnified by the Investor Selling Stockholder against civil liabilities, including liabilities under the Securities Act that may arise from any written information furnished to us by the PILE Selling Stockholder specifically for use in this prospectus, in accordance with the related registration rights agreements, or we may be entitled to contribution.

Once sold under the registration statement, of which this prospectus forms a part, the shares of common stock will be freely tradable in the hands of persons other than our affiliates.

112

MATERIAL U.S. FEDERAL INCOME TAX CONSIDERATIONS

The following discussion is a summary of the material U.S. federal income tax considerations with respect to the acquisition, ownership, and disposition of shares of our Common Stock issued pursuant to this Offering. This summary does not provide a complete analysis of all potential U.S. federal income tax considerations relating thereto. The information provided below is based upon provisions of the U.S. Internal Revenue Code of 1986, as amended (the “Code”), Treasury regulations promulgated thereunder, administrative rulings, and judicial decisions currently in effect. These authorities may change at any time, possibly retroactively, or the Internal Revenue Service (the “IRS”) might interpret the existing authorities differently. In either case, the tax considerations of owning or disposing of our Common Stock could differ from those described below. As a result, we cannot assure you that the tax consequences described in this discussion will not be challenged by the IRS or will be sustained by a court if challenged by the IRS.

This summary does not address the tax considerations arising under the laws of any non-U.S. state or local jurisdiction, or under U.S. federal gift and estate tax laws, except to the limited extent provided below. In addition, this discussion does not address tax considerations applicable to an investor’s particular circumstances or to investors that may be subject to special tax rules, including, without limitation:

●

banks, insurance companies, or other financial institutions;

●

partnerships or entities or arrangements treated as partnerships or other pass-through entities for U.S. federal tax purposes (or investors in such entities);

●

corporations that accumulate earnings to avoid U.S. federal income tax;

●

persons subject to the alternative minimum tax or Medicare contribution tax on net investment income;

●

tax-exempt organizations or tax-qualified retirement plans;

●

controlled foreign corporations or passive foreign investment companies;

●

dealers in securities or currencies;

●

traders in securities that elect to use a mark-to-market method of accounting for their securities holdings;

●

persons that own, or are deemed to own, more than 5% of our capital stock (except to the extent specifically set forth below);

●

certain former citizens or former long-term residents of the United States;

●

persons who hold our Common Stock as a position in a hedging transaction, “straddle,” “conversion transaction,” or other risk reduction transaction;

●

persons who do not hold our Common Stock as a capital asset within the meaning of Section 1221 of the Code (generally, for investment purposes); or

●

persons deemed to sell our Common Stock under the constructive sale provisions of the Code.

In addition, if a partnership or entity classified as a partnership for U.S. federal income tax purposes is a beneficial owner of our Common Stock, the tax treatment of a partner in the partnership or an owner of the entity will depend upon the status of the partner or other owner and the activities of the partnership or other entity. Accordingly, this summary does not address tax considerations applicable to partnerships that hold our Common Stock, and partners in such partnerships should consult their tax advisors.

INVESTORS CONSIDERING THE PURCHASE OF OUR COMMON STOCK SHOULD CONSULT THEIR OWN TAX ADVISORS REGARDING THE APPLICATION OF THE U.S. FEDERAL INCOME AND ESTATE TAX LAWS TO THEIR PARTICULAR SITUATIONS AND THE CONSEQUENCES OF FOREIGN, STATE, OR LOCAL LAWS, AND TAX TREATIES.

113

Consequences to U.S. Holders

The following is a summary of the U.S. federal income tax consequences that will apply to a U.S. holder of our securities. For purposes of this discussion, you are a U.S. holder if, for U.S. federal income tax purposes, you are a beneficial owner of our securities, other than a partnership, that is:

●

an individual citizen or resident of the United States;

●

a corporation or other entity taxable as a corporation created or organized in the United States or under the laws of the United States, any State thereof, or the District of Columbia;

●

an estate trust whose income is subject to U.S. federal income tax regardless of its source; or

●

a trust (x) whose administration is subject to the primary supervision of a U.S. court and which has one or more “United States persons” (within the meaning of Section 7701(a)(30) of the Code) who have the authority to control all substantial decisions of the trust or (y) which has made a valid election to be treated as a “United States person.”

Distributions

We do not anticipate paying any cash dividends on our common stock in the foreseeable future. However, if we do make distributions in cash or other property on our common stock, those payments will constitute dividends for U.S. tax purposes to the extent paid from our current or accumulated earnings and profits, as determined under U.S. federal income tax principles. To the extent our distributions exceed both our current and our accumulated earnings and profits, the excess will constitute a return of capital that will first reduce your basis in our common stock, but not below zero, and then will be treated as gain from the sale or other disposition of stock as described below under “Sale, Exchange or Other Taxable Disposition of Common Stock.”

Dividend income may be taxed to an individual U.S. holder at rates applicable to long-term capital gains, provided that a minimum holding period and other limitations and requirements are satisfied, with certain exemptions. Any dividends that we pay to a U.S. holder that is a corporation will qualify for the dividends received deduction if the requisite holding period is satisfied, subject to certain limitations. U.S. holders should consult their own tax advisors regarding the holding period and other requirements that must be satisfied to qualify for the reduced tax rate on dividends or the dividends-received deduction.

Sale, Exchange, or Other Taxable Disposition of Common Stock

A U.S. holder will generally recognize capital gain or loss on the sale, exchange, or other taxable disposition of our common stock. The amount of gain or loss will equal the difference between the amount realized on the sale and such U.S. holder’s adjusted tax basis in such common stock. The amount realized will include the amount of any cash and the fair market value of any other property received in exchange for such common stock. A U.S. holder’s adjusted tax basis in its common stock will generally equal the U.S. holder’s acquisition cost or purchase price, less any prior distributions treated as a return of capital. Gain or loss will be long-term capital gain or loss if the U.S. holder has held the common stock for more than one year. Long-term capital gains of non-corporate U.S. holders are generally taxed at preferential rates. The deductibility of capital losses is subject to certain limitations.

Information Reporting and Backup Withholding

In general, information reporting requirements may apply to dividends paid to a U.S. holder and to the proceeds of the sale or other disposition of our common stock, unless the U.S. holder is an exempt recipient. Backup withholding may apply to such payments if the U.S. holder fails to provide a taxpayer identification number, a certification of exempt status, or has been notified by the IRS that it is subject to backup withholding (and such notification has not been withdrawn).

Any amounts withheld under the backup withholding rules will be allowed as a refund or a credit against a U.S. holder’s U.S. federal income tax liability, provided the required information is timely furnished to the IRS.

114

Unearned Income Medicare Tax

A 3.8% Medicare contribution tax will generally apply to all or some portion of the net investment income of a U.S. holder that is an individual with adjusted gross income that exceeds a threshold amount ($200,000, or $250,000 if married filing jointly).

Consequences to Non-U.S. Holders

The following is a summary of the U.S. federal income tax consequences that will apply to a non-U.S. holder of our securities. For purposes of this summary, a Non-U.S. Holder is any beneficial owner of our Common Stock, other than a partnership, that is not:

●

an individual who is a citizen or resident of the United States;

●

a corporation, or other entity taxable as a corporation for U.S. federal income tax purposes, created or organized under the laws of the United States, any state therein, or the District of Columbia;

●

a trust if it (i) is subject to the primary supervision of a U.S. court and one or more U.S. persons have authority to control all substantial decisions of the trust or (ii) has a valid election in effect under applicable U.S. Treasury regulations to be treated as a U.S. person; or

●

an estate whose income is subject to U.S. income tax regardless of source.

If you are a non-U.S. citizen that is an individual, you may, in many cases, be treated as a resident alien, as opposed to a non-resident alien, by virtue of being present in the United States for at least 31 days in the calendar year and for an aggregate of at least 183 days during a three-year period ending in the current calendar year. For these purposes, all the days present in the current year, one-third of the days present in the immediately preceding year, and one-sixth of the days present in the second preceding year are counted. Resident aliens are subject to U.S. federal income tax as if they were U.S. citizens. Such an individual is urged to consult his or her own tax advisor regarding the U.S. federal income tax consequences of the ownership or disposition of our Common Stock.

Dividends

As discussed under “Dividend Policy” above, we do not currently expect to declare or pay dividends to our Common Stockholders in the foreseeable future. In the event that we do make distributions of cash or other property on our Common Stock, those distributions will constitute dividends for U.S. federal income tax purposes to the extent paid from our current or accumulated earnings and profits, as determined under U.S. federal income tax principles. Amounts not treated as dividends for U.S. federal income tax purposes will constitute a return of capital, which will first reduce a Non-U.S. Holder’s adjusted tax basis in shares of our Common Stock, but not below zero. Any remaining excess will be treated as gain realized on the sale or other disposition of our Common Stock and will be treated as described below under “Gain on Sale or Other Taxable Disposition of Our Common Stock.”

Subject to the discussion below on effectively connected income, dividends paid to a Non-U.S. Holder of our Common Stock that is not effectively connected with the Non-U.S. Holder’s conduct of a trade or business in the United States will generally be subject to U.S. federal withholding tax at a rate of 30% of the gross amount of the dividends (or such lower rate specified by an applicable income tax treaty, provided the Non-U.S. Holder furnishes a properly executed IRS Form W-8BEN or W-8BEN-E (or other applicable or successor form) certifying the Non-U.S. Holder’s qualification for the lower treaty rate). A Non-U.S. Holder that does not timely furnish the required documentation, but that qualifies for a reduced treaty rate, may obtain a refund of any excess amounts withheld by timely filing an appropriate claim for refund with the IRS. Non-U.S. Holders should consult their tax advisors regarding their entitlement to benefits under any applicable income tax treaty. If the Non-U.S. Holder holds the stock through a financial institution or other agent acting on the holder’s behalf, the holder will be required to provide appropriate documentation to the agent. The holder’s agent will then be required to provide certification to us or our paying agent, either directly or through other intermediaries. If you are eligible for a reduced rate of U.S. federal withholding tax under an income tax treaty, you may obtain a refund or credit of any excess amounts withheld by filing an appropriate claim for a refund with the IRS in a timely manner.

115

If dividends paid to a Non-U.S. Holder are effectively connected with the Non-U.S. Holder’s conduct of a trade or business in the United States (and, if required by an applicable income tax treaty, are attributable to a permanent establishment or fixed base maintained by the Non-U.S. Holder in the United States), the Non-U.S. Holder will be exempt from the U.S. federal withholding tax described above. To claim the exemption, the Non-U.S. Holder must furnish to the applicable withholding agent a valid IRS Form W-8ECI, certifying that the dividends are effectively connected with the Non-U.S. Holder’s conduct of a trade or business within the United States.

Any such effectively connected dividends will be subject to U.S. federal income tax on a net income basis at the regular rates. A Non-U.S. Holder that is a corporation also may be subject to a branch profits tax at a rate of 30% (or such lower rate specified by an applicable income tax treaty) on such effectively connected dividends, as adjusted for certain items. Non-U.S. Holders should consult their tax advisors regarding any applicable tax treaties that may provide for different rules.

Gain on Sale or Other Taxable Disposition of Our Common Stock

Subject to the discussion below under “Information Reporting and Backup Withholding” and “Foreign Account Tax Compliance Act,” a Non-U.S. Holder will generally not be subject to U.S. federal income tax on any gain realized upon the sale, exchange, or other taxable disposition of our Common Stock unless:

●

the gain (i) is effectively connected with the conduct by the Non-U.S. Holder of a U.S. trade or business, and (ii) if required by an applicable income tax treaty between the United States and the Non-U.S. holder’s country of residence, is attributable to a permanent establishment maintained by the Non-U.S. Holder in the United States (in which the special rules described below apply);

●

the Non-U.S. Holder is an individual who is present in the United States for 183 days or more in the taxable year of the sale, exchange or other disposition of our Common Stock, and certain other requirements are met (in which case the gain would be subject to a flat 30% tax, or such reduced rate as may be specified by an applicable income tax treaty, which may be offset by certain U.S. source capital losses, even though the individual is not considered a resident of the United States); or

●

the rules of the Foreign Investment in Real Property Tax Act (“FIRPTA”) treat the stock as a “U.S. real property interest” as defined in Section 897 of the Code.

The FIRPTA rules may apply to a sale, exchange, or other disposition of our Common Stock if we are, or were within the shorter of the five-year period preceding the disposition and the Non-U.S. Holder’s holding period, a “U.S. real property holding corporation” (a “USRPHC”), as defined in Section 897 of the Code. In general, we would be a USRPHC if interests in U.S. real estate comprised at least half of the value of our business assets. We do not believe that we are a USRPHC, and we do not anticipate becoming one in the future. Even if we become a USRPHC, as long as our Common Stock is regularly traded on an established securities market, such Common Stock will be treated as U.S. real property interests only if beneficially owned by a Non-U.S. Holder that actually or constructively owned more than 5% of our outstanding Common Stock at some time within the five-year period preceding the disposition.

If any gain from the sale, exchange or other disposition of our Common Stock (1) is effectively connected with a U.S. trade or business conducted by a Non-U.S. Holder, and (2) if required by an applicable income tax treaty between the United States and the Non-U.S. Holder’s country of residence, is attributable to a permanent establishment maintained by such Non-U.S. Holder in the United States, then the gain generally will be subject to U.S. federal income tax at the same graduated rates applicable to U.S. persons, net of certain deductions and credits. If the Non-U.S. Holder is a corporation, under certain circumstances, that portion of its earnings and profits that is effectively connected with its U.S. trade or business, subject to certain adjustments, generally would be subject also to a “branch profits tax.” The branch profits tax rate is 30% unless reduced by an applicable income tax treaty.

Non-U.S. Holders should consult their tax advisors regarding potentially applicable income tax treaties that may provide for different rules.

116

U.S. Federal Estate Tax

The estates of non-resident alien individuals generally are subject to U.S. federal estate tax on property with a U.S. situs. Because we are a U.S. corporation, our Common Stock will be U.S. situs property and therefore will be included in the taxable estate of a non-resident alien decedent, unless an applicable estate tax treaty between the United States and the decedent’s country of residence provides otherwise.

Informational Reporting and Backup Withholding

The Code and the Treasury regulations require those who make specified payments to report the payments to the IRS. Among the specified payments are dividends and proceeds paid by brokers to their customers. The required information returns enable the IRS to determine whether the recipient properly included the payments in income. This reporting regime is reinforced by “backup withholding” rules. These rules require the payors to withhold tax from payments subject to information reporting if the recipient fails to cooperate with the reporting regime by failing to provide their taxpayer identification number to the payor, furnishing an incorrect identification number, or failing to report interest or dividends on their returns. The backup withholding tax rate is currently 24%. The backup withholding rules do not apply to payments to corporations, whether domestic or foreign, provided they establish such exemption.

Payments to Non-U.S. Holders of dividends on our Common Stock generally will not be subject to backup withholding, and payments of proceeds made to Non-U.S. Holders by a broker upon a sale of Common Stock will not be subject to information reporting or backup withholding, in each case so long as the Non-U.S. Holder certifies its status as a Non-U.S. Holder (and we or our paying agent do not have actual knowledge or reason to know the holder is a U.S. person or that the conditions of any other exemption are not, in fact, satisfied) or otherwise establishes an exemption. The certification procedures to claim treaty benefits described under “Distributions” will generally satisfy the certification requirements necessary to avoid the backup withholding tax. We must report annually to the IRS any dividends paid to each Non-U.S. Holder and the tax withheld, if any, with respect to these dividends. Copies of these reports may be made available to tax authorities in the country where the Non-U.S. Holder resides. However, under the Treasury regulations, information returns are required to be filed with the IRS in connection with any dividends on our Common Stock paid to the Non-U.S. Holder, regardless of whether any tax was actually withheld. In addition, proceeds of the sale or other taxable disposition of our Common Stock within the United States or conducted through certain U.S.-related brokers generally will not be subject to backup withholding or information reporting, if the beneficial owner certifies, under penalties of perjury, among other things, its status as a Non-U.S. Holder (and the broker does not have actual knowledge or reason to know the holder is a U.S. person) or otherwise establishes an exemption. The payment of proceeds from the disposition of shares of our Common Stock by a Non-U.S. Holder made to or through a non-U.S. office of a broker generally will not be subject to backup withholding and information reporting, except as noted below. Information reporting, but not backup withholding, will apply to a payment of proceeds, even if that payment is made outside of the United States, if you sell our Common Stock through a non-U.S. office of a broker that is:

●

a U.S. person (including a foreign branch or office of such person);

●

a “controlled foreign corporation” for U.S. federal income tax purposes;

●

a foreign person 50% or more of whose gross income from certain periods is effectively connected with a U.S. trade or business; or

●

a foreign partnership if at any time during its tax year (a) one or more of its partners are U.S. persons who, in the aggregate, hold more than 50% of the income or capital interests of the partnership or (b) the foreign partnership is engaged in a U.S. trade or business, unless the broker has documentary evidence that the beneficial owner is a Non-U.S. Holder and certain other conditions are satisfied, or the beneficial owner otherwise establishes an exemption (and the broker has no actual knowledge or reason to know to the contrary).

Backup withholding is not an additional tax. Any amounts withheld under the backup withholding rules may be allowed as a refund or a credit against a Non-U.S. Holder’s U.S. federal income tax liability, provided the required information is timely furnished to the IRS.

117

Foreign Account Tax Compliance Act

A U.S. federal withholding tax of 30% may apply to dividends and the gross proceeds of a disposition of our Common Stock paid to a foreign financial institution (as specifically defined by the applicable rules) unless such institution enters into an agreement with the U.S. government to withhold on certain payments and to collect and provide to the U.S. tax authorities substantial information regarding U.S. account holders of such institution (which includes certain equity holders of such institution, as well as certain account holders that are foreign entities with U.S. owners). This U.S. federal withholding tax of 30% will also apply to dividends, and the gross proceeds of a disposition of our Common Stock paid to a non-financial foreign entity unless such entity provides the withholding agent with either a certification that it does not have any substantial direct or indirect U.S. owners or provides information regarding direct and indirect U.S. owners of the entity. The 30% federal withholding tax described in this paragraph cannot be reduced under an income tax treaty with the United States or by providing an IRS Form W-8BEN or similar documentation. The withholding tax described above will not apply if the foreign financial institution or non-financial foreign entity otherwise qualifies for an exemption from the rules and certifies as such on a Form W-8BEN-E (or any successor of such form). Under certain circumstances, a non-U.S. Holder might be eligible for refunds or credits of such taxes. Holders should consult with their own tax advisors regarding the possible implications of the withholding described herein.

The withholding provisions described above generally apply to proceeds from a sale or other disposition of Common Stock and to payments of dividends on our Common Stock.

THE PRECEDING DISCUSSION OF U.S. FEDERAL TAX CONSIDERATIONS IS FOR GENERAL INFORMATION ONLY. IT IS NOT TAX ADVICE. EACH PROSPECTIVE INVESTOR SHOULD CONSULT ITS OWN TAX ADVISOR REGARDING THE PARTICULAR U.S. FEDERAL, STATE, LOCAL, AND FOREIGN TAX CONSEQUENCES OF PURCHASING, HOLDING, AND DISPOSING OF OUR COMMON STOCK, INCLUDING THE CONSEQUENCES OF ANY PROPOSED CHANGE IN APPLICABLE LAWS.

118

LEGAL MATTERS

The validity of the shares of common stock offered hereby will be passed upon for us by Lucosky Brookman LLP, 101 Wood Avenue South, 5^th Floor, Woodbridge, New Jersey.

EXPERTS

CBIZ CPAs P.C., an independent registered public accounting firm, has audited the financial statements of the Company for the year ended December 31, 2025, as set forth in their report included herein and is included in reliance upon such report and upon the authority of such firm as experts in accounting and auditing. The report of CBIZ CPAs P.C. contains an explanatory paragraph about the ability of the Company to continue as a going concern.

Marcum LLP, an independent registered public accounting firm, audited the financial statements of the Company for the year ended December 31, 2024, as set forth in their report included herein. The report of Marcum LLP contains explanatory paragraphs about the ability of the Company to continue as a going concern and a restatement of previously issued financial statements for a correction of an error.

WHERE YOU CAN FIND MORE INFORMATION

We have filed with the SEC a registration statement on Form S-1 under the Securities Act, with respect to the shares of common stock being offered by this prospectus. This prospectus, which constitutes part of the registration statement, does not contain all the information set forth in the registration statement or the exhibits and schedules filed therewith. Statements contained in this prospectus regarding the contents of any contract or any other document that is filed as an exhibit to the registration statement are not necessarily complete, and each such statement is qualified in all respects by reference to the full text of such contract or other document filed as an exhibit to the registration statement.

Immediately upon the effectiveness of the registration statement of which this prospectus forms a part, we will become subject to the information and reporting requirements of the Exchange Act and, in accordance with this law, will file periodic reports, proxy statements, and other information with the SEC. We also maintain a website at https://lakewoodamedex.com/. Upon the effectiveness of the registration statement of which this prospectus forms a part, you may access these materials free of charge as soon as reasonably practicable after they are electronically filed with, or furnished to, the SEC. Information contained on our website is not a part of this prospectus, and the inclusion of our website address in this prospectus is an inactive textual reference only.

119

INDEX TO FINANCIAL STATEMENTS

LAKEWOOD-AMEDEX BIOTHERAPEUTICS INC.

		Page
Financial Statements For the Years Ended December 31, 2025 and 2024:
Reports of Independent Registered Public Accounting Firms (PCAOB ID: 199)		F-2
Reports of Independent Registered Public Accounting Firms (PCAOB ID: 688)		F-3
Balance Sheets As of December 31, 2025 and 2024		F-4
Statements of Operations For the Years Ended December 31, 2025 and 2024		F-5
Statements of Stockholders’ Equity (Deficit) For the Years Ended December 31, 2025 and 2024		F-6
Statements of Cash Flows For the Years Ended December 31, 2025 and 2024		F-7
Notes to the Financial Statements For the Years Ended December 31, 2025 and 2024		F-8

F-1

REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM

To the Stockholders and Board of Directors of
Lakewood-Amedex Biotherapeutics Inc.

Opinion on the Financial Statements

We have audited the accompanying balance sheet of Lakewood-Amedex Biotherapeutics Inc. (the “Company”) as of December 31, 2025, the related statements of operations, changes in stockholders’ equity (deficit) and cash flows for the year ended December 31, 2025, and the related notes (collectively referred to as the “financial statements”). In our opinion, the financial statements present fairly, in all material respects, the financial position of the Company as of December 31, 2025, and the results of its operations and its cash flows for the year ended December 31, 2025, in conformity with accounting principles generally accepted in the United States of America.

Explanatory Paragraph — Going Concern

The accompanying financial statements have been prepared assuming that the Company will continue as a going concern. As more fully described in Note 1, the Company has a significant working capital deficiency, has incurred significant losses and needs to raise additional funds to meet its obligations and sustain its operations. These conditions raise substantial doubt about the Company’s ability to continue as a going concern. Management’s plans in regard to these matters are also described in Note 1. The financial statements do not include any adjustments that might result from the outcome of this uncertainty.

Basis for Opinion

These financial statements are the responsibility of the Company’s management. Our responsibility is to express an opinion on the Company’s financial statements based on our audit. We are a public accounting firm registered with the Public Company Accounting Oversight Board (United States) (“PCAOB”) and are required to be independent with respect to the Company in accordance with the U.S. federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.

We conducted our audit in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the financial statements are free of material misstatement, whether due to error or fraud. The Company is not required to have, nor were we engaged to perform, an audit of its internal control over financial reporting. As part of our audit we are required to obtain an understanding of internal control over financial reporting but not for the purpose of expressing an opinion on the effectiveness of the Company’s internal control over financial reporting. Accordingly, we express no such opinion.

Our audit included performing procedures to assess the risks of material misstatement of the financial statements, whether due to error or fraud, and performing procedures that respond to those risks. Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the financial statements. Our audit also included evaluating the accounting principles used and significant estimates made by management, as well as evaluating the overall presentation of the financial statements. We believe that our audit provides a reasonable basis for our opinion.

/s/ CBIZ CPAs P.C.

CBIZ CPAs P.C.

We have served as the Company’s auditor since 2013 (such date takes into account the acquisition of the attest business of Marcum LLP by CBIZ CPAs P.C. effective November 1, 2024).

Tampa, Florida
March 11, 2026

F-2

REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM

To the Stockholders and Board of Directors of
Lakewood-Amedex Biotherapeutics Inc.

Opinion on the Financial Statements

We have audited the accompanying balance sheet of Lakewood-Amedex Biotherapeutics Inc. (the “Company”) as of December 31, 2024, the related statements of operations, changes in stockholders’ equity and cash flows for the year ended December 31, 2024, and the related notes (collectively referred to as the “financial statements”). In our opinion, the financial statements present fairly, in all material respects, the financial position of the Company as of December 31, 2024, and the results of its operations and its cash flows for the year ended December 31, 2024, in conformity with accounting principles generally accepted in the United States of America.

Explanatory Paragraph — Going Concern

Explanatory Paragraph — Correction of an Error

As discussed in Note 2 to the financial statements, the Company has restated the financial statements for the year ended December 31, 2024 to correct the calculation net loss attributable to common shareholders used in computing loss per share.

Basis for Opinion

These financial statements are the responsibility of the Company’s management. Our responsibility is to express an opinion on the Company’s financial statements based on our audits. We are a public accounting firm registered with the Public Company Accounting Oversight Board (United States) (“PCAOB”) and are required to be independent with respect to the Company in accordance with the U.S. federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.

We conducted our audits in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audits to obtain reasonable assurance about whether the financial statements are free of material misstatement, whether due to error or fraud. The Company is not required to have, nor were we engaged to perform, an audit of its internal control over financial reporting. As part of our audits we are required to obtain an understanding of internal control over financial reporting but not for the purpose of expressing an opinion on the effectiveness of the Company’s internal control over financial reporting. Accordingly, we express no such opinion.

Our audits included performing procedures to assess the risks of material misstatement of the financial statements, whether due to error or fraud, and performing procedures that respond to those risks. Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the financial statements. Our audits also included evaluating the accounting principles used and significant estimates made by management, as well as evaluating the overall presentation of the financial statements. We believe that our audits provide a reasonable basis for our opinion.

/s/ Marcum LLP

Marcum LLP

We have served as the Company’s auditor from 2013 to June 2025.

Tampa, Florida

May 2, 2025, except for the effects of the reverse stock split described in Note 13, as to which the date is January 9, 2026, and except for the effects of the restatement described in Note 2, as to which the date is March 11, 2026.

F-3

LAKEWOOD-AMEDEX BIOTHERAPEUTICS INC.
BALANCE SHEETS

	As of December 31,
	2025			2024
ASSETS
Current assets:
Cash and cash equivalents	$	236,400		$	681,098
Prepaid expenses and other current assets		68,989			92,883
Total current assets		305,389			773,981

Operating lease right-of-use asset		158,852			274,194
Property and equipment, net		9,225			13,859
Other assets		8,132			8,547
Total assets	$	481,598		$	1,070,581

LIABILITIES AND STOCKHOLDERS’ EQUITY (DEFICIT)
Current liabilities:
Accounts payable	$	381,041		$	166,467
Accrued expenses and other current liabilities		303,872			221,641
Accrued interest – related parties		100,881			—
Operating lease liability – current portion		119,306			112,520
Notes payable – related parties		1,500,000			—
Total current liabilities		2,405,100			500,628

Operating lease liability, net of current portion		41,035			160,342
Total liabilities		2,446,135			660,970

Commitments and Contingencies

Stockholders’ equity (deficit):
Series A convertible preferred stock, voting, $0.0001 par value, 8,000,000 shares authorized, dividends do not accrue, anti-dilution protection, 6,590,045 shares issued and outstanding at December 31, 2025 and 2024, convertible into 1,113,224 shares of common stock, liquidation preference of $7.70 per share or $8,567,059.		659			659
Series B convertible preferred stock, voting, $0.0001 par value, 52,500,000 shares authorized, cumulative dividends at 8%, anti-dilution protection, 23,811,426 shares issued and outstanding, at December 31, 2025 and 2024, convertible into 4,022,206 shares of common stock, liquidation preference of $6.22 per share or $25,001,997.		2,381			2,381
Common stock, $0.0001 par value, 125,000,000 shares authorized; 7,043,330 and 6,991,355 issued; 6,995,469 and 6,943,494 outstanding at December 31, 2025 and 2024, respectively.		704			699
Additional paid-in capital		51,532,849			50,059,365
Accumulated deficit		(53,351,130	)		(49,503,493	)
Treasury stock, 47,861 shares, at cost, at December 31, 2025 and 2024		(150,000	)		(150,000	)
Total stockholders’ equity (deficit)		(1,964,537	)		409,611
Total liabilities and stockholders’ equity (deficit)	$	481,598		$	1,070,581

F-4

LAKEWOOD-AMEDEX BIOTHERAPEUTICS INC.
STATEMENTS OF OPERATIONS

	For the Years Ended December 31,
	2025			2024
Revenue	$	—		$	—

Operating expenses:
Research and development		1,255,266			2,103,366
General and administrative		2,512,470			1,917,154
Depreciation		4,634			6,300
Total operating expenses		3,772,370			4,026,820

Loss from operations		(3,772,370	)		(4,026,820	)

Other income (expense):
Interest income		25,614			142,596
Interest expense		(100,881	)		(5,000	)
Loss on fraud incident		—			(1,042,459	)
Realized loss on investment		—			(722	)
Other income		—			77,000
Total other income (expense), net		(75,267	)		(828,585	)

Net loss	$	(3,847,637	)	$	(4,855,405	)

Basic and diluted net loss per common share	$	(0.84	)	$	(0.99	)

Weighted average number of common shares outstanding, basic and diluted		6,962,718			6,909,063

F-5

LAKEWOOD-AMEDEX BIOTHERAPEUTICS INC.
STATEMENTS OF CHANGES IN STOCKHOLDERS’ EQUITY (DEFICIT)

	Series A Preferred Stock				Series B Preferred Stock				Common Stock				Additional Paid-in		Accumulated			Treasury Stock						Total Stockholders’ Equity
	Shares		Amount		Shares		Amount		Shares		Amount		Capital		Deficit			Shares			Amount			(Deficit)
Balance at January 1, 2024		6,590,045	$	659		23,811,426	$	2,381		6,867,477	$	686	$	49,302,689	$	(44,648,088	)		(33,784	)	$	(100,000	)	$	4,558,327
Stock issued to directors										67,571		7		143,993											144,000
Stock-based compensation														269,669											269,669
Conversion of notes payable – related party for common stock										56,307		6		199,994											200,000
Forgiveness of accrued interest on notes payable – related party														143,020											143,020
Repurchase of common stock																			(14,077	)		(50,000	)		(50,000	)
Net loss																(4,855,405	)								(4,855,405	)
Balance at December 31, 2024		6,590,045	$	659		23,811,426	$	2,381		6,991,355	$	699	$	50,059,365	$	(49,503,493	)		(47,861	)	$	(150,000	)	$	409,611
Stock issued to directors										51,975		5		119,995											120,000
Stock-based compensation														1,353,489											1,353,489
Net loss																(3,847,637	)								(3,847,637	)
Balance at December 31, 2025		6,590,045	$	659		23,811,426	$	2,381		7,043,330	$	704	$	51,532,849	$	(53,351,130	)		(47,861	)	$	(150,000	)	$	(1,964,537	)

F-6

LAKEWOOD-AMEDEX BIOTHERAPEUTICS INC.
STATEMENTS OF CASH FLOWS

	For the Years Ended December 31,
	2025			2024
Cash flows from operating activities:
Net loss	$	(3,847,637	)	$	(4,855,405	)
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation		4,634			6,300
Realized loss on sale of investment		—			722
Stock-based compensation		1,353,489			269,669
Amortization of right-of-use asset		115,342			112,294
Amortization of purchase discounts on investments		—			(66,521	)
Changes in operating assets and liabilities:
Prepaid expenses and other current assets		24,309			(2,794	)
Accounts payable		214,574			(332,599	)
Accrued expenses and other current liabilities		202,231			(753,966	)
Accrued interest – related parties		100,881			5,000
Operating lease liability		(112,521	)		(106,022	)
Net cash used in operating activities		(1,944,698	)		(5,723,322	)

Cash flows from investing activities:
Purchases of investments		—			(4,333,688	)
Proceeds from sale of investment		—			585,198
Proceeds from maturities of investments		—			7,675,000
Purchase of property and equipment		—			(1,846	)
Net cash provided by investing activities		—			3,924,664

Cash flows from financing activities:
Repurchase of stock		—			(50,000	)
Proceeds from notes payable – related parties		1,500,000			—
Net cash provided by (used in) financing activities		1,500,000			(50,000	)

Net decrease in cash and cash equivalents		(444,698	)		(1,848,658	)
Cash and cash equivalents – beginning of the year		681,098			2,529,756
Cash and cash equivalents – end of the year	$	236,400		$	681,098

Non-cash investing and financing activities:
Common stock issued to board members for settlement of accrued board fees	$	120,000		$	144,000

Conversion of principal on notes payable – related party for common stock	$	—		$	200,000

Forgiveness of accrued interest on notes payable – related party	$	—		$	143,020

F-7

NOTES TO FINANCIAL STATEMENTS
FOR THE YEARS ENDED DECEMBER 31, 2025 AND 2024

NOTE 1 — BUSINESS, LIQUIDITY AND CAPITAL RESOURCES

Overview

Lakewood-Amedex Biotherapeutics Inc., a Nevada corporation (“Lakewood-Amedex” or the “Company”), headquartered in University Park, Florida, was formed on July 11, 2006 under the name Nu Pharmas, Inc. (“Nu Pharmas”).

On January 26, 2007, Nu Pharmas acquired substantially all the assets of Renaissance Nutraceuticals, Inc., a Delaware corporation. On April 9, 2007, Nu Pharmas changed its name to Amedex Therapeutics, Inc. (“Amedex Therapeutics”). On November 11, 2007, Amedex Therapeutics acquired substantially all the assets of Lakewood Pharmaceuticals, Inc., a Delaware corporation. On February 1, 2008, Amedex Therapeutics changed its name to Lakewood-Amedex Inc. On June 5, 2025, Lakewood-Amedex Inc. changed its name to Lakewood-Amedex Biotherapeutics Inc. and redomiciled as a Nevada corporation.

Lakewood-Amedex is focused on leveraging unique, pioneering science to address unmet needs in the treatment of serious infectious diseases, improving patient outcomes, and significantly reducing the threat posed by antibiotic-resistant bacterial strains like MRSA, NDM-l, and many others. The Company’s product candidates consist of antimicrobials that are targeted at acute and chronic infectious diseases, and which are delivered locally to the site of infection. As of February 2026, the Company has 68 patents and 36 pending patent applications covering its products and technologies for application in major pharmaceutical markets. The Company has successfully completed its first human clinical trial for its lead product, the broad-spectrum Bisphosphocin^® (anti-bacterial) Nu-3 for the topical treatment of chronically infected diabetic foot ulcers. The Company plans to conduct an additional dose comparative phase 2 study, which is expected to identify the dose for phase 3 and later commercialization, as well as the most appropriate administration regimen for Nu-3 gel formulation in mildly infected diabetic foot ulcers. Furthermore, early-stage pipeline compounds will be further characterized to identify the best compound/clinical indication match for further non-clinical and clinical evaluation.

Liquidity, Capital Resources and Going Concern Considerations

The accompanying financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”) on a going concern basis, which contemplates the realization of assets and the satisfaction of liabilities in the normal course of business. Accordingly, the financial statements do not include any adjustments relating to the recoverability of assets and classification of liabilities that might be necessary should the Company be unable to continue as a going concern. However, there is uncertainty about the Company’s ability to successfully raise cash through financing activities and the Company’s management does not believe that cash on hand will be adequate to fund its limited overhead and other cash requirements over the next 12 months. The Company recognized a net loss of approximately $3.8 million for the year ended December 31, 2025. The Company used approximately $1.9 million in net cash from operating activities for the year ended December 31, 2025 and has historically incurred losses from operations and expects to continue to generate negative cash flows as the Company implements its business plan. These factors raise substantial doubt about the Company’s ability to continue as a going concern within one year after the date that the financial statements are issued.

In order to continue as a going concern, the Company will need, among other things, additional capital resources. Management’s plan is to obtain such resources for the Company by seeking third party equity and/or debt financing and obtaining capital from the board of directors and/or significant shareholders sufficient to meet its minimal operating expenses. In May 2025, the Company raised $1.25 million in gross proceeds through the issuance of short-term convertible promissory notes bearing interest at 10% and maturing on March 31, 2026. In conjunction with this financing, two previously issued short-term notes, $200,000 issued on March 7, 2025, and $50,000 issued on April 7, 2025, were modified to align with the terms of the new convertible notes, resulting in a total of $1.5 million in convertible notes outstanding as of the reporting date. The principal and accrued interest of these notes will automatically convert to registered common stock at $8.00 per share on a direct listing on Nasdaq. The Company has also entered into an agreement with a placement agent and broker dealer to provide consulting services, capital markets advisory services, broker dealer services, and service as a placement agent. The placement agent will assist the Company in preparing for a direct listing on Nasdaq and raising approximately $6.8 million ($7.5 million investment net of estimated expenses) from an offering of Convertible Preferred Stock prior to the date of listing.

F-8

NOTES TO FINANCIAL STATEMENTS
FOR THE YEARS ENDED DECEMBER 31, 2025 AND 2024

NOTE 1 — BUSINESS, LIQUIDITY AND CAPITAL RESOURCES (cont.)

Management cannot provide any assurances that the Company will be successful in accomplishing any of its plans. As such, there is substantial doubt about the Company’s ability to continue as a going concern.

NOTE 2 — SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES

The financial statements presented herein have been prepared in accordance with U.S. GAAP.

Use of Estimates

The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities as of the date of the financial statements, and that affect the amount of expenses reported for each period.

Actual results could differ from those which result from using such estimates. Management also utilizes various other estimates, including but not limited to depreciation, income tax expense, the valuation of deferred tax assets, determining the fair value of the Company’s common stock, the valuation of securities underlying stock-based compensation, and lease-related estimates which include the determination of the lease term, the assessment of renewal or termination options, and the incremental borrowing rate used to measure right-of-use (ROU) assets and lease liabilities. The results of any changes in accounting estimates are reflected in the financial statements of the period in which the changes become evident. Estimates and assumptions are reviewed periodically, and the effects of revisions are reflected in the period that they are determined to be necessary.

Concentrations of Credit Risk

Financial instruments which potentially subject the Company to concentrations of credit risk consist principally of cash and cash equivalents on deposit with financial institutions. The Company maintains its cash and cash equivalents in bank accounts, certain balances of which may exceed federally insured limits. Deposit accounts are insured by the Federal Deposit Insurance Corporation (“FDIC”) up to applicable limits; however, amounts in excess of those limits, as well as certain other cash equivalents, are not insured. As of December 31, 2025, the Company had $150,667 cash and cash equivalents that were either in excess of FDIC-insured limits or otherwise uninsured. In addition, the Company maintains deposits with financial institutions located within the same geographic region, which may result in a concentration of credit risk. The Company has not experienced any losses related to these deposits.

Fair Value Hierarchy

FASB ASC 825-10-50 — “Financial Instruments” requires disclosure of the fair value of certain financial instruments. The carrying value of cash and cash equivalents, prepaid expenses and other current assets, accounts payable and accrued expenses, as reflected in the balance sheets, approximate fair value because of the short-term maturity of these instruments. Our notes payable — related parties have interest rates that approximate market and mature in three months, therefore the carrying amounts approximate their fair values.

F-9

NOTES TO FINANCIAL STATEMENTS
FOR THE YEARS ENDED DECEMBER 31, 2025 AND 2024

NOTE 2 — SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (cont.)

Fair value is defined as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. The established fair value hierarchy requires an entity to maximize the use of observable inputs and minimize the use of unobservable inputs when measuring fair value. Accounting standards describe three levels of inputs that may be used to measure fair value:

●

Level 1 — Observable inputs such as quoted prices (unadjusted) in active markets for identical assets or liabilities;

●

Level 2 — Inputs other than quoted prices that are observable for the asset or liability, either directly or indirectly. These include quoted prices for similar assets or liabilities in active markets; quoted prices for identical or similar assets or liabilities that are not active; and model-driven valuations whose inputs are observable or whose significant value drivers are observable. Valuations may be obtained from, or corroborated by, third-party pricing services;

●

Level 3 — Unobservable inputs to measure fair value of assets and liabilities for which there is little, if any market activity at the measurement date, using reasonable inputs and assumptions based upon the best information at the time, to the extent that inputs are available without undue cost and effort.

The Company uses appropriate valuation techniques based on the available best inputs to measure the fair value of its investments. When available, the Company measures fair value using Level 1 inputs because they generally provide the most reliable evidence of fair value. Level 3 inputs are used only when Level 1 or Level 2 inputs are not available. Valuations are obtained from a third-party custodian and determined using closing prices on nationally recognized stock exchanges.

The methodology described above may produce a fair value calculation that may not be indicative of net realizable value or reflective of future fair values. Furthermore, while the Company believes its valuation methodology is appropriate and consistent with other market participants, the use of different methodologies or assumptions to determine the fair value of certain financial instruments could result in a different fair value measurement at the reporting date.

There were no significant transfers between Level 1 and Level 2 or into or out of Level 3 during the years ended December 31, 2025 and 2024.

Revenue Recognition

The Company recognizes revenue in accordance with ASC 606, “Revenue From Contracts with Customers” (“ASC 606”), which requires that five steps be completed to determine when revenue can be recognized: (i) identify the contract with the customer; (ii) identity the performance obligations in the contract; (iii) determine the transaction price; (iv) allocate the transaction price; and (v) recognize revenue when or as the entity satisfies a performance obligation. The Company records revenue under ASC 606 as services are performed for the customer. The Company did not recognize any revenue during the years ended December 31, 2025 and 2024.

Cash and Cash Equivalents

Cash represents cash deposits held at financial institutions. Cash equivalents include short-term highly liquid investments of sufficient credit quality that are readily convertible to known amounts of cash and have original maturities of three months or less. Cash equivalents are carried at cost, plus accrued interest, which approximates fair value. Cash equivalents are held for the purpose of meeting short-term liquidity requirements, rather than for investment purposes. Cash and cash equivalents are held at major financial institutions or United States Treasury.

F-10

NOTES TO FINANCIAL STATEMENTS
FOR THE YEARS ENDED DECEMBER 31, 2025 AND 2024

NOTE 2 — SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (cont.)

Leases

The Company determines the initial classification and measurement of its right-of-use assets and lease liabilities at the lease commencement date and thereafter if modified. The lease term includes any renewal options and termination options that the Company is reasonably assured to exercise. The present value of lease payments is determined by using the interest rate implicit in the lease, if that rate is readily determinable; otherwise, the Company uses its incremental borrowing rate. The incremental borrowing rate is determined by using the rate of interest that the Company would pay to borrow on a collateralized basis an amount equal to the lease payments for a similar term and in a similar economic environment.

Fixed lease expense for operating leases is recognized on a straight-line basis, unless the right-of-use assets have been impaired, over the reasonably assured lease term based on the total lease payments and is included in general and administrative expenses in the statements of operations.

Variable lease payments that are not based on an index or that result from changes to an index subsequent to the initial measurement of the corresponding lease liability are not included in the measurement of lease right of use (ROU) assets or liabilities and instead are recognized in earnings in the period in which the obligation for those payments is incurred.

Preferred Stock

The Company applies the accounting standards for distinguishing liabilities from equity when determining the classification and measurement of its preferred stock. Preferred shares subject to mandatory redemption are classified as liability instruments and are measured at fair value. Conditionally redeemable preferred shares (including preferred shares that feature redemption rights that are either within the control of the holder or subject to redemption upon the occurrence of uncertain events not solely within the Company’s control) are classified as temporary equity. At all other times, preferred shares are classified as stockholders’ equity.

Net Loss per Common Share

The Company computes earnings per share (“EPS”) in accordance with ASC 260-10 issued by the Financial Accounting Standards Board.

Basic net loss per common share is computed by dividing net loss, adjusted for any undeclared dividends on convertible preferred stock, by the weighted average number of common shares outstanding during the period. Diluted net loss per common share is computed by dividing net loss, adjusted for any undeclared dividends on convertible preferred stock, by the weighted average number of common shares outstanding, plus the impact of common shares, if dilutive, resulting from the exercise of outstanding stock options, warrants and convertible preferred stock.

For the year ended December 31, 2025:

Net loss	$	(3,847,637	)
Series B cumulative dividends (undeclared)		(2,000,160	)
Net loss attributable to common stockholders	$	(5,847,797	)

The following securities are excluded from the calculation of weighted average dilutive common shares because their inclusion would have been anti-dilutive:

	December 31,
	2025		2024
Series A convertible preferred shares		6,590,045		6,590,045
Series B convertible preferred shares		23,811,426		23,811,426
Common stock warrants		266,899		334,467
Stock options		1,269,772		709,594
Total potentially dilutive shares		31,938,142		31,445,532

F-11

NOTES TO FINANCIAL STATEMENTS
FOR THE YEARS ENDED DECEMBER 31, 2025 AND 2024

NOTE 2 — SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (cont.)

Restatement

Subsequent to the issuance of the Company’s financial statements for the year ended December 31, 2024, management identified an error in the calculation of net loss attributable to common stockholders used in computing loss per common share. The error resulted from the omission of $2,000,160 of undeclared dividends on Series B convertible preferred stock from net loss attributable to common stockholders.

The error resulted in an understatement of basic and diluted loss per share for the year ended December 31, 2024. The error did not affect previously reported net loss, total equity, cash flows, or total assets and liabilities.

Management evaluated the materiality of the error in accordance with ASC 250, Accounting Changes and Error Corrections, and concluded that the error was material to the previously issued financial statements for the year ended December 31, 2024. Accordingly, the accompanying financial statements have been Restated to correct the error.

The impact of the restatement on the Company’s statement of operations for the year ended December 31, 2024 was as follows:

	As Previously Reported			Adjustment			As Restated
Net loss	$	(4,855,405	)	$	—		$	(4,855,405	)
Series B cumulative dividends		—			(2,000,160	)		(2,000,160	)
Net loss attributable to common stockholders	$	(4,855,405	)		(2,000,160	)	$	(6,855,565	)
Basic and diluted net loss per share	$	(0.70	)	$	(0.29	)	$	(0.99

Lakewood-Amedex Biotherapeutics Inc. S-1