As filed with the Securities and Exchange Commission on December 10, 2025.

Registration No. 333-

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

________________________________________________

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

________________________________________________

STARTON HOLDINGS, INC.
(Exact name of registrant as specified in its charter)

DELAWARE
(Jurisdiction of incorporation or organization)

________________________________________________

2834		33-2448745
(Primary Standard Industrial Classification Code Number)		(I.R.S. Employer Identification Number)

215 College Road, Suite 300, Paramus, NJ 07652
(Address, including zip code, and telephone number, including area code, of Registrant’s principal executive offices)

(800) 449-5405
(Registrant’s telephone number, including area code)

________________________________________________

Pedro Lichtinger Waisman
Chairman and Chief Executive Officer
215 College Road, Suite 300
Paramus, NJ 07652
(800) 449-5405
(Name, address and phone number of agent for service)

________________________________________________

Copies of Communications to:

Stephen M. Cohen, Esq.
Lauren Taylor, Esq.
Vincent A. Vietti, Esq.
Fox Rothschild LLP
2001 Market Street, Suite 1700
Philadelphia, PA 19103
Tel: (215) 299-2744
Email: smcohen@foxrothschild.com
lwtaylor@foxrothschild.com
vvietti@foxrothschild.com

Stephen E. Older, Esq.
Andrew J. Terjesen, Esq.
McGuireWoods LLP
1251 Avenue of the Americas
20th Floor
New York, New York 10020
Tel: (212) 548-2100

––––––––––––––––––––––––––––––––––––––––––––––––––––

Approximate date of commencement of proposed sale to the public: As soon as practicable after the effective date of this Registration Statement.

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, please 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 COMMISSION, ACTING PURSUANT TO SAID SECTION 8(a), MAY DETERMINE.

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The information in this prospectus is not complete and may be changed. We may not sell these securities until the registration statement filed with the Securities and Exchange Commission is effective. This prospectus is not an offer to sell these securities and it is not soliciting an offer to buy these securities in any jurisdiction where the offer or sale is not permitted.

Subject to Completion, Dated December 10, 2025

PRELIMINARY PROSPECTUS

STARTON HOLDINGS, INC.

6,666,667 Shares of Common Stock

This prospectus (this “Prospectus”) relates to the initial public offering of 6,666,667 shares of common stock by Starton Holdings, Inc., a Delaware corporation (“we”, “our”, “us”, “Starton” or the “Company”).

Prior to this offering, there has been no public market for our shares of common stock. It is currently estimated that the initial public offering price per share will be between $5.00 and $7.00. We have applied to list our shares of common stock on the NASDAQ Capital Market (“Nasdaq”) under the symbol “STA.” It is a condition to the closing of this offering that the common stock offered hereby has been duly listed on Nasdaq.

We are an “emerging growth company” and a “smaller reporting company” as defined under the federal securities laws and, as such, we have elected to comply with certain reduced reporting requirements for this prospectus and may elect to do so in future filings. See “Prospectus Summary-Implications of Being an Emerging Growth Company and a Smaller Reporting Company.”

The purchase of the securities offered through this Prospectus involves a high degree of risk. See section entitled “Risk Factors” starting on page 12.

NEITHER THE SECURITIES AND EXCHANGE COMMISSION (“SEC”) NOR ANY STATE SECURITIES COMMISSION HAS APPROVED OR DISAPPROVED THESE SECURITIES OR DETERMINED IF THIS PROSPECTUS IS TRUTHFUL OR COMPLETE. ANY REPRESENTATION TO THE CONTRARY IS A CRIMINAL OFFENSE.

	Per share	Total
Initial public offering price	$	$
Underwriting discount(1)	$	$
Proceeds, before expenses, to Starton Holdings, Inc.	$	$

____________

(1) See the section titled “Underwriting” for a description of the compensation payable to the underwriters.

We have granted the underwriters an option for a period of 45 days to purchase up to an additional 1,000,000 shares from the Company, less the underwriting discounts and commission, solely to cover over-allotments, if any.

The underwriters expect to deliver the shares against payment in New York, New York, on or about , 2025.

Revere Securities LLC

Dated: , 2025

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TABLE OF CONTENTS

		Page
GLOSSARY OF DEFINED TERMS		iii
PROSPECTUS SUMMARY		1
THE OFFERING		8
SUMMARY FINANCIAL DATA		10
RISK FACTORS		12
MARKET AND INDUSTRY DATA		47
USE OF PROCEEDS		48
DIVIDEND POLICY		49
DOMESTICATION TRANSACTIONS		50
CAPITALIZATION		52
DILUTION		54
SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS		56
MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS		57
BUSINESS		65
MANAGEMENT		94
EXECUTIVE COMPENSATION		102
CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS, AND DIRECTOR INDEPENDENCE		110
PRINCIPAL STOCKHOLDERS		113
DESCRIPTION OF CAPITAL STOCK		115
SHARES ELIGIBLE FOR FUTURE SALE		120
UNDERWRITING		122
LEGAL MATTERS		131
INTERESTS OF NAMED EXPERTS AND COUNSEL		131
DISCLOSURE OF COMMISSION POSITION OF INDEMNIFICATION FOR SECURITIES ACT LIABILITIES		132
WHERE YOU CAN FIND MORE INFORMATION		133
FINANCIAL STATEMENTS		F-1

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You should rely only on the information contained in this Prospectus. We have not authorized anyone to provide you with different information. We are not making an offer of these securities in any state where the offer is not permitted.

Neither we nor any of the underwriters have authorized anyone to provide any information or to make any representations other than those contained in this prospectus or in any free writing prospectuses we have prepared. Neither we nor any of the underwriters take responsibility for, and can provide no assurance as to the reliability of, any other information that others may give you. This prospectus is an offer to sell only the shares offered hereby, but only under circumstances and in jurisdictions where it is lawful to do so. The information contained in this prospectus is current only as of its date, regardless of the time of delivery of this prospectus or of any sale of our shares of common stock.

Trademarks, Service Marks, and Trade Names

We do not own or have rights to use common law trademarks, service marks, or trade names in connection with our business in the U.S. or in certain foreign jurisdictions.

Solely for convenience, the trademarks, service marks, logos, and trade names referred to in this prospectus are without the ® and ™ symbols, but such references are not intended to indicate, in any way, that we will not assert, to the fullest extent under applicable law, our rights or the rights of the applicable licensors to these trademarks, service marks and trade names. This prospectus contains additional trademarks, service marks and trade names of others, which are the property of their respective owners. All trademarks, service marks and trade names appearing in this prospectus are, to our knowledge, the property of their respective owners. We do not intend our use or display of other companies’ trademarks, service marks, copyrights, or trade names to imply a relationship with, or endorsement or sponsorship of us by, any other companies.

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GLOSSARY OF DEFINED TERMS

As used in this Prospectus, unless otherwise noted or the context otherwise requires:

“we”, “our”, “us”, “our business”, the “Company”, “Starton” and similar references refer to Starton Holdings, Inc. and its subsidiaries.

“ACA” means the Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act.

“AUC” means area under the curve.

“ANDA” means Abbreviated New Drug Application.

“API” means active pharmaceutical ingredients.

“AWP” means Average Wholesale Price.

“BA” means bioavailability.

“BTKi” means Bruton’s Tyrosine Kinase inhibitors.

“CARES Act” means Coronavirus Aid, Relief, and Economic Security Act.

“CAR-T” means chimeric antigen receptor — T cell.

“CLL” means chronic lymphocytic leukemia.

“Code” means the Internal Revenue Code of 1986, as amended.

“CR” means complete response.

“CMC” means chemistry, manufacturing, and controls.

“Cmax” means maximum plasma concentration.

“CMS” means U.S. Centers for Medicare and Medicaid Services.

“cGMP” means Current Good Manufacturing Practices.

“CRO” means contract research organizations.

“CTM” means Clinical Trial Materials.

“DEA” means the U.S. Drug Enforcement Administration.

“DGCL” means the Delaware General Corporation Law, as amended.

“DIA” means Drug-in-adhesive.

“DOJ” means U.S. Department of Justice.

“ECG” means Electrocardiogram.

“Exchange Act” means the U.S. Securities Exchange Act of 1934, as amended.

“FDA” means United States Food and Drug Administration.

“FDC Act” means the United States Federal Food, Drug, and Cosmetic Act.

“FINRA” means Financial Industry Regulatory Authority, Inc.

“FTC” means Federal Trade Commission.

“GAAP” means U.S. generally accepted accounting principles.

“GCPs” means Good Clinical Practices.

“GLP” means good laboratory practice.

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“HIPAA” means Health Insurance Portability and Accountability Act of 1996.

“HITECH” means U.S. Health Information Technology for Economic and Clinical Health Act of 2009.

“IMiD” means immunomodulatory imide drugs.

“IND” means Investigational New Drug.

“IRB” means institutional review board.

“LLD” means lenalidomide.

“MM” means multiple myeloma.

“Nasdaq” means the Nasdaq Stock Market.

“NCCN” means National Comprehensive Cancer Network guidelines.

“NCE” means new chemical entity.

“NDA” means New Drug Application

“NOAEL” means no-observed adverse event level.

“NOLs” means net operating loss carryforwards.

“OCR” means Oral Controlled Release.

“ODA” means Orphan Drug Act.

“ODD” means Orphan Drug Designation.

“OTC” means over the counter.

“ORR” means objective tumor response rate.

“PCT” means Patent Cooperation Treaty of 1970.

“PDUFA” means Prescription Drug User Fee Act.

“PFS” means progression free survival rate.

“PREA” means Pediatric Research Equity Act.

“PTO” means Patent and Trademark Office.

“REMS” means Risk Evaluation and Mitigation Strategy.

“RRMM” means Relapsed Refractory Multiple Myeloma.

“SC” means subcutaneous.

“SCID” means severe combined immunodeficiency.

“SEC” means the U.S. Securities and Exchange Commission.

“Securities Act” means the Securities Act of 1933, as amended.

“TDS” means transdermal delivery systems.

“T1/2” means half-time.

“TCJA” means Tax Cuts and Jobs Act of 2017.

“TEAE” means treatment-emergent adverse event.

“Transfer Agent” means Computershare.

“TTF” means time to total treatment failure.

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PROSPECTUS SUMMARY

This summary highlights selected information contained in greater detail elsewhere in this prospectus and does not contain all of the information that you should consider in making an investment decision. Before investing in our common stock, you should carefully read this entire prospectus, including our financial statements and the related notes appearing at the end of this prospectus and the information set forth under the “Risk Factors,” “Special Note Regarding Forward-Looking Statements” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” sections of this prospectus. Unless the context indicates or suggests otherwise, references to “we,” “our,” “us,” “Starton” or the “Company,” refer to Starton Holdings, Inc., a Delaware corporation.

Overview

We are a clinical-stage biotechnology company focused on improving standard-of-care therapies for people with cancer through application of our proprietary platform of delivery technology systems. We use continuous delivery of FDA-approved, active ingredients in an attempt to develop and bring products to market in either new indications or with enhanced outcomes in existing indications. In collaboration with our consulting company, McKinsey & Company, we evaluated over 80,000 potential applications to identify those applications where we believed our continuous delivery technology would bring the most benefit to patients. Based on the results of that evaluation, we are focused initially on the treatment of hematologic malignancies (blood cancers). Our algorithms also seek to identify drug candidates in areas of significant unmet medical needs that have not been able to achieve FDA approval due to tolerability concerns. This process allows us to prioritize targeted opportunities.

Our lead program, STAR-LLD, is a continuous delivery system of the generic form of Revlimid® (lenalidomide), which is a prescription medicine owned by Bristol Myers Squibb that is currently used to treat adults with multiple myeloma (MM), mantle cell and other lymphomas. With STAR-LLD, we are seeking to develop a subcutaneous and an oral controlled release formulation, as well as a transdermal patch in parallel to improve the probability of success. We are pursuing multiple indications in multiple myeloma and chronic lymphocytic leukemia (CLL), in combinations with CAR-T therapies and potentially expanding in other cancers, including B-cell lymphomas, and solid tumors.

We expect to announce our second program, which is currently in the formulation development stage, within the next 12 to 18 months. It has been our practice to only disclose new programs once we have filed for provisional intellectual property protection.

We also have developed another product candidate, STAR-OLZ, which is a multi-day transdermal delivery of the prescription medicine Zyprexa® (olanzapine), an atypical antipsychotic owned by Eli Lilly and Company, although it is no longer under patent protection. Our STAR-OLZ product candidate targets an indication in chemotherapy induced nausea and vomiting (CINV); however, this program is on hold while we focus on our lead program, STAR-LLD.

Our Platform

Our platform enables the use of continuous drug delivery using three continuous delivery methods: (1) subcutaneous delivery by ambulatory pump, (2) oral controlled release tablet and/or capsule, and (3) transdermal delivery using patch technology. We developed a series of algorithms that enable us to select and prioritize active ingredients from well understood and successfully commercialized medicines, such as Revlimid® (lenalidomide). Our identified candidates are progressing through the required stages of the FDA development process; however, none of our candidates have been approved by the FDA at this point. When selecting possible candidates, we target superiority in efficacy and/or safety to the original medicine delivery form, expansion of use or new indications. Our selected medicines offer what we believe to be the best opportunity to enhance efficacy, patient convenience, and improve the side-effect profile, as well as increase levels of drug treatment compliance. We seek to identify new indications where efficacy data exists, but where tolerability may have prevented the originator from obtaining an on-label indication. We develop and manufacture Phase 1 Good Manufacturing Practices (GMP) quality investigational products using each of the three continuous delivery methods. To maintain cost-efficiency, we outsource the manufacturing of products for Phase 2 and beyond. By exploring development of oral subcutaneous and transdermal delivery methods, we seek to expand the number of medicines we may be able to deliver to patients continuously, based on optimizing the pharmacokinetic/pharmacodynamic characteristics of the medicine to reduce side effects and improve the therapeutic index for each cancer. We believe the development of subcutaneous, oral controlled release, and transdermal delivery methods in parallel using the same drug product have the potential to improve the probability of success of the FDA approving our combination products. The objective of our continuous delivery products is to reduce the drugs’ “area under the curve” (AUC) and maximum blood concentration (Cmax) of a drug in order to improve the therapeutic index for treatment.

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We intend to leverage the 505(b)(2) pathway for nearly all the preclinical activities for our combination product candidates. Because we target off patent medicines or medicines that will be off patent by the time we launch our product, we do not need to develop the manufacturing of the active pharmaceutical ingredient (“API”), as it is readily available through generic manufacturers. However, because we target superiority or new indications for these approved APIs, we will need to conduct full clinical development programs including Phase 1, Phase 2, and Phase 3 clinical programs. In addition, we need to develop the manufacturing process and chemistry, manufacturing, and control (CMC) of the Oral Controlled Release (OCR), transdermal, and subcutaneous (SC) delivery systems. However, pursuing the 505(b)(2) regulatory pathway may not increase the likelihood that our combination product candidate will be approved and may not provide a faster path to regulatory approval. The reference listed drug for the STAR-LLD program is Revlimid® (lenalidomide) for all the Starton delivery platforms.

Overview of Subcutaneous, Oral Controlled Release, and Transdermal Drug Delivery Methods

Subcutaneous drug delivery is a method of delivering drugs below the skin into the layer of tissue beneath the skin. In general, the benefits of subcutaneous delivery include fast absorption, low variability and versatility. Depending on the drug being administered, subcutaneous delivery may allow drugs to absorb more rapidly into the bloodstream and may have broader applicability than other drug delivery methods. For example, on-body injectors are a growing method of delivering insulin to patients.

Oral controlled-release drug delivery provides a mechanism to modulate drug release over time, maintaining therapeutic concentrations while minimizing peaks and troughs associated with conventional immediate-release formulations. By delivering medication at a predetermined rate, controlled-release systems enhance drug exposure consistency, improve pharmacokinetic profiles and therapeutic index, and can reduce dose frequency, which supports adherence in chronic therapy settings. These technologies also help mitigate dose-related adverse effects by avoiding high peak plasma levels and may improve gastrointestinal tolerability for drugs prone to irritation. Additionally, controlled-release platforms can target specific regions of the GI tract, optimize absorption windows, and enable therapeutic use of compounds with short half-lives or narrow therapeutic indices. Collectively, oral controlled-release dosage forms play a critical role in modern pharmaceutical development, offering patient-centric benefits and often improving therapeutic outcomes and safety. Oral controlled release has been used across multiple products and its technology is well understood. We have internally developed an OCR formulation to deliver lenalidomide that is currently awaiting regulatory approval to initiate a human healthy volunteer bioavailability study. We also have engaged Bend Biosciences, a contract development manufacturing organization who specializes in the development and manufacturing of OCR products, to assist in the further development of our OCR formulation for lenalidomide.

Transdermal drug delivery is a method of delivering drugs systemically by applying a drug formulation onto intact and healthy skin. According to the National Institutes of Health, as of April 2023, there were approximately twenty-three (23) prescription transdermal patches available in the U.S. market, as well as multiple over-the-counter transdermal patches. Drug-in-adhesive (DIA) matrix transdermal delivery is the technology behind the majority of the transdermal patches in the market. Transdermal patches provide a non-invasive drug delivery method designed to deliver medication through the skin into systemic circulation at a controlled rate. They bypass gastrointestinal and first-pass hepatic metabolism, which can improve bioavailability and reduce gastrointestinal side effects. By maintaining steady plasma concentrations over extended periods, transdermal systems help avoid peaks and troughs associated with oral dosing, supporting stable therapeutic exposure and improved tolerability. They also enhance patient adherence through less frequent dosing, and are especially useful for drugs with short half-lives, narrow therapeutic windows, or poor oral absorption. In addition, patches offer rapid utility cessation — drug delivery can be stopped simply by removing the patch — providing a safety advantage in dose titration or adverse event management. Overall, transdermal patches are a valuable pharmaceutical modality for controlled systemic drug delivery, especially in chronic therapy settings.

Further, because the FDA considers two of our delivery platforms to be combination products that combine a device (the transdermal patches or subcutaneous pump) with the drug, the regulatory and development process is generally more complex as it frequently involves review by different FDA Centers. Oral controlled release is well accepted and does not face this regulatory complexity.

Overview of STARTICLES and STARSILON

We have a history working with transdermal patches. We have the capability to manufacture early phase products and test the transport of the active molecule across cadaver skin which is the industry standard for testing transdermal products. We have developed proprietary technology to enhance the transport of acceptable drugs using our STARSILON transdermal patch delivery system which may increase the delivery three to five fold over drug in adhesive matrices.

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STARTICLES, which is complementary to our STARSILON platform, refers to proprietary and novel solid-state particulates suspended in a drug-in-adhesive patch for delivery of APIs with traditionally high melting points and low solubility and is intended to improve the availability of the API for achieving higher permeation rates through the skin. STARTICLES as well as STARSILON are transdermal patch technologies that would be filed as combination drug products with the FDA.

The STARSILON and STARTICLES intellectual property, currently patent pending, would, if granted, extend our IP portfolio protection through 2045, excluding any patent term adjustments or patent term extensions. We are the assignee of the IP and we retain full global ownership of the provisional patent applications with the technology and methodology being developed internally.

Development Pipeline for Starton Platform of Product Candidates

Our product STAR-LLD (lenalidomide) reflects our strategy to develop continuous delivery products for new indications or with superior on-label outcomes. The following table summarizes its status. We are developing in parallel three methods to deliver STAR-LLD; subcutaneous (SC), oral controlled release (OCR) and transdermal (TDS) formulations. This provides us with multiple pathways to seek approval for our product candidates and multiple potential opportunities to address patients’ specific needs.

PRODUCT PORTFOLIO FOR CLINICAL ASSETS

Our Strategy

Our strategy is to identify and develop promising drug candidates for our continuous delivery platform and, if we receive regulatory approval, to commercialize products that may be safer and more effective than existing treatments in hematologic malignancies. Drugs that address unmet needs can have access to multiple pathways for approval such as accelerated, breakthrough designation, fast-track, etc. We focus on new indications with existing strong data supporting efficacy and tolerability, or in existing indications where a clear unmet medical need can be addressed. We also focus on drugs that have expired, or close to expiring, patents. We have access to the active ingredients through generic companies that have registered drug master files in the US. Our strategy is based upon our belief that it is more efficient and effective to focus our efforts on approved drug products that are either off-patent or approaching loss of patent exclusivity to provide a faster to market and lower cost. However, there is no guarantee that this approach will result in faster approval, or any approval, of our product candidates.

We have capabilities in the development of OCRs, continuous subcutaneous (SC) delivery and drug-in-adhesive matrix transdermal delivery. We can deliver small molecules and manage different dose sizes, with multiple delivery methods being developed in parallel, while tailoring the characteristics of a specific medicine. In addition to our current programs, we intend to identify and develop other promising drug candidates with our continuous delivery platform. We focus on highly successful drugs that are close to being generic or are generic.

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The goal of each delivery system is to target effective blood concentration for a specific drug which will reduce the AUC and Cmax of a drug to improve tolerability and avoid periods of subtherapeutic dosing due to a short elimination T1/2.

The combination of new indications, proprietary delivery systems, and new dosing regimens form the basis of our intellectual property.

The key components of our strategy are:

• Advance STAR-LLD Through Clinical Trials: Lenalidomide in MM. Lenalidomide is a key part of the standard of care immunomodulatory drugs (IMiD) used in the treatment of MM and lymphoma. We developed a formulation for STAR-LLD and a Phase 1b protocol was authorized by the FDA, which focused on second line RRMM patients who would be using Revlimid® with a proteasome inhibitor and dexamethasone. The study was conducted with a total of six patients. The Phase 1b study was initiated by a contract with a global clinical research organization, dated September 7, 2023. We announced interim, top-line data in June 2024. An abstract with these results was presented at AACR in April 2025. We have submitted the results to and have met with the FDA. The FDA has agreed to allow us to initiate a Phase 2a clinical study in RRMM second line relapsed/refractory patients scheduled to receive bortezomib, dexamethasome and lenalidomide. The “go to market’ indication we will be seeking is for use in high-risk RRMM where there is a significant unmet need. The registration studies will focus on RRMM in patients at 2nd line or higher treatment with high risk for failure from the expression of chromosomal abnormalities or high levels of beta-2 microglobulin.

Upon acceptance of NDA approval, we intend to commercialize STAR-LLD in MM, currently estimated in 2030, which would be after Revlimid becomes fully genericized at the end of the first quarter of 2028.

• Advance STAR-LLD Through Clinical Trials: Lenalidomide in CLL. Currently, there is a black box warning for the use of lenalidomide for CLL; however, the FDA has encouraged us to submit a request for a CLL Phase 1 design meeting to present and discuss options. Upon agreement with the FDA, we intend to run a complete clinical development program. There are currently no IMiD class approved treatments for the most common form of adult leukemia — CLL. Bruton’s Tyrosine Kinase inhibitors (BTKi) are a class of targeted therapies that have become a standard part of treatment for many patients with CLL. Although there are several effective BTK inhibitors in the market and in development, nearly all patients using BTK inhibitors eventually progress following or during their treatment. The standard of care usually follows BTKi failure with a BCL2i like venetoclax. When a patient progresses on a BCL2i and a BTKi there is a limited armamentarium available that provides a meaningful response and survival. To enable a new regimen for this underserved population we have identified BTKi and BCL2i relapsed/refractory patients (typically 3rd line and greater) as a major unmet medical need, in terms of improved tolerability or efficacy. We intend to evaluate the combination of lenalidomide OCR in combination with obinutuzumab. Upon acceptance of NDA approval, we intend to commercialize STAR-LLD in CLL, currently estimated in 2033.

• Enhancement of CAR-T therapies for MM and lymphoma. Chimeric antigen receptor T-cell (CAR-T) therapy has revolutionized treatment for relapsed/refractory hematologic malignancies, offering unprecedented response rates in late-line disease. Despite these advances, in patients with lymphoma 40 – 60% relapse within 12 months of infusion, and post-CAR-T progression is associated with poor survival, typically 6 – 9 months. Data from MM CAR-T therapies indicates failure of 45% and 24% at 12 months with major difference between Ide-cel and Cilta-cel. These patients represent a rapidly expanding population with limited standardized treatment options.

Starton is planning to provide funding for several IIT studies at major academic centers in lymphoma and multiple myeloma. These will examine lymphoma patients who have progressed following CAR-T therapy to recover the function of the CAR-T cells and lead to an objective response, as well as RRMM patients in combination with CAR-T for the first 30-days after the infusion to improve the biochemical response to treatment over CAR-T alone. These studies will provide insight into the mechanisms and success rate of STAR-LLD in each population, and will form the basis for a new drug application (NDA) for the enhancement and success of the combination in patient outcomes. Assuming the studies are successful, we will run a Phase 2 registration trial for each indication. Upon acceptance of NDA approvals, we intend to commercialize STAR-LLD in combination with CAR-T cell therapies in lymphoma and multiple myeloma, currently estimated in 2030 and 2031.

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For any of these pathways, we may not obtain FDA approval in the time frame we anticipate or may never obtain FDA approval. The FDA may also impose additional requirements or require additional studies or protocol amendments during any phase. We cannot guarantee that the FDA will agree with any of our trial designs and may require multiple meetings to develop a pathway forward for any of our candidates in any indication.

• Establish Commercial Operations in U.S. Market. In order for us to commercialize products in U.S. markets, we must obtain regulatory approvals for our product candidates, which is an expensive process that typically takes many years and involves extensive compliance with requirements covering research and development, testing, manufacturing, quality control, labeling, and promotion of drugs for human use. If we receive regulatory approval for our portfolio of continuous delivery products, it is our intention to commercialize such products by deploying sales representatives, medical science liaisons (MSLs), digital marketing, and medical organizations in the U.S. and establishing distributor networks or licensee arrangements in other markets around the world. We believe that establishing our own commercial operations in our core strategic market (the U.S.) strengthens our ability to negotiate with strategic participants in the market and is an important component of our strategy. We also believe that through our strategic relationships with commercial payors and medical organizations we can accelerate the size and development of the market at a marginal incremental cost, and therefore, we may be able to achieve faster and higher market penetrations when compared to commercializing the products ourselves. See the section titled “Risk Factors” for a broader explanation of commercial risks.

With respect to our STAR-LLD product candidates, since Revlimid® is under IP protection until April of 2028 in the U.S., we plan to commercialize STAR-LLD beyond then, subject to receiving all required regulatory approvals.

• Expand Continuous Delivery Platform. We have identified a pipeline of product candidates for formulation and development using a continuous delivery system. We believe each product will have the opportunity to address a significant unmet medical need in its therapeutic area by achieving a new indication, enhance efficacy, and/or reduce side effects. The candidates were identified by our algorithm and screened to ensure technological fit to our platform. As we advance, we intend to continue to prioritize and develop each of these transdermal patch candidates. Product candidates have been selected based on their level of potential for improvement in both efficacy and tolerability as well as fit with the delivery platform including, half-life, molecule size, dose size and specific characteristics of the molecule. Candidates are only disclosed following proof of concept studies that allow us to file for provisional patent protection.

Risks Associated with Our Business

Our business is subject to a number of risks for which investors should be aware before making a decision to invest in our shares of common stock. These risks are more fully described in the section titled “Risk Factors” immediately following this prospectus summary. These risks include, among others, the following:

• We are a clinical stage biotechnology company with a limited operating history and have not yet generated any revenue.

• 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.”

• If we are unable to successfully develop or commercialize any of our existing or new products, or fail to do so on a timely or cost effective basis, our operating results will suffer and the amount of our available liquidity and capital resources will be adversely affected.

• We will need to expend a significant amount of resources on research and development, which may not lead to successful product introductions.

• Failures of or delays in clinical trials are common and have many causes, and such failures or delays could result in increased costs to us and could prevent or delay our ability to obtain regulatory approval and commence product sales for new products.

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• The testing required to support our clinical trials for the regulatory approval of our products is conducted primarily by independent third parties. Any failure by any of these third parties to perform this testing properly and in a timely manner may have an adverse effect upon our ability to obtain regulatory approvals.

• Our products or product candidates may cause adverse effects or have other properties that could delay or prevent their regulatory approval or limit the scope of any approved package insert or market acceptance or result in significant negative consequences during development or following marketing approval.

• If our products or product candidates do not produce the effects intended or if they cause undesirable side effects, our business may suffer.

• We will incur operating losses for the foreseeable future.

• We face intense competition from development companies including startups and large pharmaceutical companies that could limit or even make obsolete our market objectives.

• Our future success depends on our ability to attract and retain key employees and consultants.

• We depend on our ability to protect our intellectual property and proprietary rights.

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

• We and our service providers may be subject to a variety of privacy and data security laws and contractual obligations, which could increase compliance costs, and our actual or perceived failure to comply with such laws and obligations could subject us to potentially significant liability, fines or penalties and otherwise harm our business.

• Our ability to use our net operating loss carryforwards to offset future taxable income may be subject to certain limitations.

• We and our manufacturing partners are subject to extensive governmental regulation and face significant uncertainties and potentially significant costs associated with our efforts to comply with applicable regulations. Any non-compliance may result in fines or other sanctions, including debarment, product seizures, product recalls, injunctive actions, and criminal prosecutions, which could result in material adverse effects to our business, financial position, and results of operations.

• We will require substantial additional financing to achieve our goals, and failure to obtain this necessary capital when needed on acceptable terms, or at all, could force us to delay, limit, reduce or terminate our product development programs, commercialization efforts or other operations.

• Our stock price may be volatile, and you may not be able to resell shares of our common stock at or above the price you paid.

Company Information

Our holding company that is conducting this offering, Starton Holdings, Inc., was incorporated on December 17, 2024 under the laws of the State of Delaware. Starton Therapeutics, Inc., a corporation organized under the laws of British Columbia on February 7, 2017, was formerly our holding company, however, became a subsidiary of Starton Holdings, Inc. as part of a corporate reorganization completed in November 2025, which is described in greater detail in the section titled “Domestication Transactions”. All our business operations are conducted through our subsidiary, Starton Therapeutics, Inc., a Delaware corporation.

Our principal executive offices are located at 215 College Road, Suite 300, Paramus, New Jersey, 07652 USA. Our telephone number is (800) 449-5405. Our corporate web address is www.startontx.com. The information contained on, or accessible through, our website shall not be deemed incorporated into and is not a part of this prospectus or the registration statement of which it forms a part. We have included our website in this prospectus solely as an inactive textual reference.

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

We are an emerging growth company as defined in the Jumpstart Our Business Startups Act of 2012, as amended (JOBS Act). We will remain an emerging growth company until the earlier of (1) the last day of the fiscal year following the fifth anniversary of the closing of this offering, (2) the last day of the fiscal year in which we have total annual gross revenue of at least $1.235 billion, (3) the date on which we are deemed to be a “large accelerated filer” as defined in Rule 12b-2 under the Exchange Act, which would occur if at least $700.0 million of our equity securities are held by non-affiliates as of the last business day of the second quarter of that fiscal year, or (4) the date on which we have issued more than $1.0 billion in non-convertible debt securities during the prior three-year period. An emerging growth company we may take advantage of specified reduced reporting requirements, and we are relieved of certain other significant requirements that are otherwise generally applicable to public companies. As an emerging growth company,

• we may present only two years of audited financial statements, plus unaudited financial statements for any interim period, and related Management’s Discussion and Analysis of Financial Condition and Results of Operations in this prospectus;

• we may avail ourselves of the exemption from the requirement to obtain an attestation and report from our auditors on the assessment of our internal control over financial reporting pursuant to the Sarbanes-Oxley Act of 2002 (Sarbanes-Oxley Act);

• we may provide reduced disclosure about our executive compensation arrangements;

• we are exempt from compliance with the requirements of the Public Company Accounting Oversight Board (PCAOB) regarding the communication of critical audit matters in the auditor’s report on the financial statements; and

• we may not require stockholder non-binding advisory votes on executive compensation or golden parachute arrangements.

We have elected to take advantage of certain of the reduced disclosure obligations in the registration statement of which this prospectus is a part and may elect to take advantage of other reduced reporting requirements in future filings. As a result, the information that we provide to our stockholders may be different than you might receive from other public reporting companies in which you hold equity interests.

In addition, the JOBS Act provides that as an emerging growth company, we can take advantage of an extended transition period for complying with new or revised accounting standards and delaying the adoption of these accounting standards until they apply to private companies. We have elected to avail ourselves of this exemption from new or revised accounting standards, and, therefore, we will not be subject to the same new or revised accounting standards at the same time as other public companies that are not emerging growth companies or those that have opted out of using such extended transition period, which may make comparison of our financial statements with such other public companies more difficult. We may take advantage of these reporting exemptions until we no longer qualify as an emerging growth company, or, with respect to adoption of certain new or revised accounting standards, until we irrevocably elect to opt out of using the extended transition period. As a result, our financial statements may not be comparable to companies that comply with new or revised accounting standards as of public company effective dates.

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 and will be able to take advantage of these scaled disclosures for so long as our common stock held by non-affiliates is less than $250.0 million measured on the last business day of our second fiscal quarter, or our annual revenue is less than $100.0 million during the most recently completed fiscal year and our common stock held by non-affiliates is less than $700.0 million measured on the last business day of our second fiscal quarter.

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THE OFFERING

Shares of Common Stock offered by the Company		6,666,667 shares of common stock
Shares of Common Stock that may be offered by the Company pursuant to the Underwriters Over-Allotment Option		1,000,000 shares of common stock
Shares of Common Stock outstanding before the offering		31,694,386 shares of common stock as of the date hereof, including shares of common stock issuable in the future, if at all, upon the exchange of an equal number of exchangeable shares of Exchangeco.
Shares of Common Stock outstanding after the offering		38,694,386 shares of common stock (or approximately 39,694,386 if the underwriter’s over-allotment option to purchase additional shares of our shares of common stock from us is exercised in full).
Assumed Offering Price by the Company		$6.00
Use of proceeds		We estimate that the net proceeds to us from the sale of shares of our shares of common stock in this offering will be approximately $37,200,000 (or approximately $42,780,000 if the underwriter’s over-allotment option to purchase additional shares of our shares of common stock from us is exercised in full), based upon the assumed initial public offering price of $6.00 per share, which is the midpoint of the estimated offering price range set forth on the cover page of this prospectus, and after deducting estimated underwriting discounts and commissions and estimated offering expenses payable by us. We intend to use a majority of the net proceeds from the offering to support product development activities for STAR-LLD our leading drug delivery candidate; and for working capital and other general corporate purposes, including payment of certain outstanding trade payables and amounts due and owing to related parties. Proceeds are expected to fully fund the Phase 2 multiple myeloma clinical trial for STAR-LLD in relapsed/refractory patients (second line and higher) and allow us to initiate a Phase 1 study in CLL for STAR-LLD and provide working capital that is expected to last for at least one year. See “Use of Proceeds” and “Certain Relationships and Related Transactions, and Director Independence — Deferred Consulting and Service Fees.”
Trading Market		This is the initial public offering of our shares of common stock. We have applied to list the shares of common stock on the NASDAQ Capital Market under the symbol “STA.”
Lock-Up Agreements		We, our successors, all of our directors, officers and holders of more than 5.0% of our outstanding common stock have agreed with the underwriters, subject to certain exceptions, not to sell, transfer or dispose of, directly or indirectly, any of our shares of common stock or securities convertible into or exercisable or exchangeable for our common stock for a period of 180 days after the date of this prospectus. See “Underwriting” for more information.

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Representative’s Warrants		Upon the closing of this offering, we have agreed to issue to Revere Securities LLC, as representative of the underwriters, warrants that will be exercisable for the period commencing six months from the effective date of the registration statement of which this prospectus forms a part and expiring three years after such date, entitling the representative to purchase up to 5% of the number of shares of common stock sold in this offering (including any shares of common stock sold pursuant to the exercise of the underwriter’s option), at an exercise price per share equal to 125% of the public offering price. For additional information regarding our arrangement with the underwriters, see the section titled “Underwriting.”
Risk Factors		The shares of common stock offered hereby involves a high degree of risk and should not be purchased by investors who cannot afford the loss of their entire investment. See “Risk Factors”.

The number of shares of our common stock to be outstanding after this offering is based on 31,694,386 shares of our common stock outstanding as of December 1, 2025, and excludes the following:

• 7,488,778 shares of common stock are issuable upon the exercise of outstanding stock options as of December 1, 2025, issued under our 2025 Omnibus Equity Incentive Plan;

• 844,555 shares of common stock reserved for issuance pursuant to future awards under our 2025 Omnibus Equity Incentive Plan; and

• 9,999,019 shares of special voting shares equal to the number of shares of common stock that are issuable upon the exchange of exchangeable shares issued by Exchangeco in our November 2025 corporate reorganization.

Except as otherwise indicated, all information contained in this prospectus assumes or gives effect to:

• our December 9, 2025 1-for-3 reverse stock split;

• no exercise by the underwriters of their over-allotment option to purchase up to an additional 1,000,000 shares of our common stock; and

• no exercise of the outstanding options described above.

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SUMMARY FINANCIAL DATA

You should read the following summary financial data together with our financial statements and the related notes appearing at the end of this prospectus and the “Management’s Discussion and Analysis of Financial Condition and Results of Operations” section of this prospectus. We derived the statement of operations data for the years ended March 31, 2025 and 2024 from our audited financial statements appearing elsewhere in this prospectus. We derived the summary statements of operations data for six months ended September 30, 2025 and 2024 and the summary balance sheet data as of September 30, 2025 from the unaudited interim financial statements included elsewhere in this prospectus. The unaudited interim financial statements were prepared on the same basis as our audited financial statements and reflect, in the opinion of management, all adjustments, which include only normal, recurring adjustments that are necessary to present fairly the results for the interim periods presented. Our historical results are not necessarily indicative of the results that may be expected in the future, and our results for any interim period are not necessarily indicative of results that may be expected for any full year.

Consolidated Statements of Operations Data

	For the Six Months Ended September 30,						For the Year Ended March 31,
	2025			2024			2025			2024
Operating expenses:
Research and development	$	2,730,968		$	2,887,274		$	5,727,733		$	4,796,926
Research and development – related party		823,425			899,213			1,828,781			1,919,675
General and administrative		3,466,616			3,445,479			6,683,621			8,180,819
General and administrative – related party		36,000			36,000			72,000			100,630
Total operating expenses		7,057,009			7,267,966			14,312,135			14,998,050
Operating loss		(7,057,009	)		(7,267,966	)		(14,312,135	)		(14,998,050	)

Other income (expense):
Interest income, net		3,470			6,237			10,238			39
Interest expense – related party		(9,526	)		—			—			—
Realized gain on sale of assets		__			__			5,000,000			__
Loss on disposal of patents		__			__			(168,370	)		__
Other income (expense)		(80	)		—			(7,702	)		—
Total other income		(6,136	)		6,237			4,834,166			39
Loss before taxes		(7,063,145	)		(7,261,729	)		(9,477,969	)		(14,998,011	)
Income tax benefit		—			—			—			3,460
Net loss		(7,063,145	)		(7,261,729	)		(9,477,969	)		(14,994,551	)
Net loss per common share – basic and diluted		(0.08	)		(0.08	)		(0.11	)		(0.18	)
Weighted average common shares – basic and dilutive		93,341,267			88,545,547			89,886,805			85,414,789
Net loss		(7,063,145	)		(7,261,729	)		(9,477,969	)		(14,994,551	)
Other comprehensive income:
Foreign currency translation adjustments		(14,523	)		(10,141	)		2,869			(45,795	)
Comprehensive loss		(7,077,668	)		(7,271,870	)		(9,475,100	)		(15,040,346	)

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	As of September 30, 2025
	Actual(1)			Pro forma(2)		Proforma as adjusted(3)
Consolidated Balance Sheet Data:
Cash	$	1,071,148		36,738,908		37,810,056
Total assets		6,797,624		36,738,908		43,536,532
Total liabilities		10,145,725		(461,092	)	9,684,633
Total stockholders’ equity (deficit)		(3,348,101	)	37,200,000		33,851,899

____________

(1) The actual balance sheet data represents the historical balance sheet data of Starton Therapeutics, Inc. as of September 30, 2025.

(2) The proforma as adjusted balance sheet data represents the balance sheet data of Starton Holdings, Inc. and reflects the issuance and sale by us of 6,666,667 shares of our common stock in this offering, after deducting the estimated underwriting discounts and commissions and estimated offering expenses payable by us, at an assumed initial public offering price of $6.00 per share, which is the midpoint of the price range set forth on the cover page of this prospectus.

(3) The proforma as adjusted information discussed above is illustrative only and will be adjusted based on the actual initial public offering price and other terms of this offering determined at pricing. A $1.00 increase (decrease) in the assumed initial public offering price of $6.00 per share, which is the midpoint of the price range set forth on the cover page of this prospectus, would increase (decrease) the amount of cash, working capital, total assets and total stockholders’ equity on a proforma as adjusted basis by approximately $6.2 million, assuming the number of shares offered by us, as set forth on the cover page of this prospectus, remains the same and after deducting the estimated underwriting discounts and commissions and estimated offering expenses payable by us. We may also increase or decrease the number of shares we are offering. Each increase (decrease) of 1.0 million shares offered by us would increase (decrease) cash, working capital, total assets and total stockholders’ equity on a proforma as adjusted basis by approximately $5.6 million, assuming the assumed initial public offering price of $6.00 per share, which is the midpoint of the price range set forth on the cover page of this prospectus, remains the same, and after deducting the estimated underwriting discounts and commissions and estimated offering expenses payable by us.

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RISK FACTORS

Investing in our common stock is speculative and involves a high degree of risk. You should carefully consider the risks and uncertainties described below, the section of this prospectus titled “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and our financial statements and related notes appearing at the end of this prospectus, before investing in shares of our common stock. The risks and uncertainties described below are not the only ones we face. Additional risks and uncertainties that we are unaware of, or that we currently believe are not material, may also become important factors that affect us. If any of the following risks occur, our business, operating results and prospects could be materially harmed. In that event, the price of our common stock could decline, and you could lose part or all of your investment. This prospectus also contains forward-looking statements that involve risks and uncertainties. See “Special Note Regarding Forward-Looking Statements.” Our actual results could differ materially and adversely from those anticipated in these forward-looking statements as a result of certain factors, including those set forth below.

Risks Related to Our Financial Condition and Capital Requirements

We are a clinical stage biopharmaceutical company with a limited operating history and no products approved for commercial sale. We have incurred net losses since our inception, we anticipate that we will incur significant losses for the foreseeable future, and we may never achieve or maintain profitability.

We were established and began operations in 2017. Our operations to date have been limited to financing and staffing our company, formulating and developing potential product candidates, licensing product candidates, and conducting preclinical and clinical studies of (i) STAR-LLD for the treatment of MM, CLL and complications resulting from the disease. We have successfully completed Phase 1and 1b clinical studies for STAR-LLD in MM. We have entered a Phase 2a study for STAR-LLD in MM, primarily due to the availability of funds. If successful, and subject to our ability to raise sufficient additional funds, we intend to pursue a Phase 3 clinical study and obtain an NDA for commercialization. In addition, subject to our ability to raise sufficient additional funds, we intend to run clinical trials and commercialize STAR-LLD in CLL and Lymphoma.

Clinical studies have risks inherent to their FDA regulatory process, clinical study design, and execution. In addition, there are risks related to the manufacturing of clinical supplies, active pharmaceutical ingredients, and to manufacture a commercial scale product, arrange for a third party to do so on our behalf, or conduct sales and marketing activities necessary for successful product commercialization. Consequently, predictions about our future success or viability may prove to be inaccurate.

Accordingly, you should consider our prospects in light of the costs, uncertainties, delays and difficulties frequently encountered by companies in the early stages of development, especially early-stage clinical pharmaceutical companies such as ours. Potential investors should carefully consider the risks and uncertainties that a company with a limited operating history will face. In particular, potential investors should consider that we cannot assure you that we will be able to, among other things:

• Successfully implement or execute our current business plan, and we cannot assure you that our business plan is sound;

• Successfully manufacture or engage contract manufacturers to manufacture our clinical product candidates and establish commercial supply;

• Successfully complete the clinical trials necessary to obtain regulatory approval for the marketing of our product candidates;

• Secure market exclusivity and/or adequate intellectual property protection for our product candidates;

• Attract and retain an experienced management team and advisors.

• Secure acceptance of our product candidates in the medical community and with third-party payors and consumers;

• Raise sufficient funds in the capital markets or otherwise to effectuate our business plan; and

• Utilize the funds that we do have and/or raise in the future to efficiently execute our business strategy.

If we cannot successfully execute any of the foregoing, our business may fail, and your investment will be adversely affected.

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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.”

We incurred a net loss of $9.5 million and $15.0 million for the years ended March 31, 2025 and 2024, respectively. We had a working capital deficit of $5.9 million and $9.1 million in the years ended March 31, 2025 and 2024, respectively. Net cash used in operating activities was $8.3 million and $6.5 million in the years ended March 31, 2025 and 2024, respectively. Additionally, we had an accumulated deficit of $73.8 million and $64.3 million as of March 31, 2025 and 2024, respectively. We expect to continue to incur net losses and expects significant cash outflows for the foreseeable future. These conditions raise substantial doubt about our ability to continue as a going concern for the one year period from the date the financial statements are issued. Furthermore, our independent registered public accounting firm’s report included an explanatory paragraph that there was substantial doubt about our ability to continue as a going concern.

We identified a material weakness in our internal control over financial reporting relating to the preparation and review of our financial statements. If the remediation of this material weaknesses is not effective, or if we identify additional material weaknesses in the future or otherwise fail to maintain an effective system of internal controls, we may not be able to accurately or timely report our financial condition or results of operations, which may adversely affect our business.

As a privately-held company, we were not required to evaluate our internal control over financial reporting in a manner that meets the standards of publicly traded companies as required by Section 404(a) of the Sarbanes-Oxley Act, or Section 404. In the course of preparing the financial statements that are included in this prospectus, our management determined that a material weakness existed within our internal controls over financial reporting. The material weakness identified relates to the lack of accounting resources to properly prepare and review our financial statements. We concluded that the material weakness in our internal control over financial reporting occurred because we were a private company and did not have the necessary business processes, systems, personnel, and related internal controls necessary to satisfy the accounting and financial reporting requirements of a public company. In order to remediate the material weakness, we will continue to expend a substantial amount of effort and resources for the remediation and improvement of our internal control over financial reporting.

Even if this offering is successful, we will require substantial additional capital to finance our operations, and failure to obtain this necessary capital when needed on acceptable terms, or at all, could force us to delay, limit, reduce or terminate our development programs, commercialization efforts or other operations.

The development of biopharmaceutical product candidates, including conducting preclinical studies and clinical trials, is a very time-consuming, capital-intensive and uncertain process. Our operations have consumed substantial amounts of cash since inception. We expect our expenses to substantially increase in connection with our ongoing activities, particularly as we conduct our ongoing and planned clinical trials and potentially seek regulatory approval for our leading candidates and any future product candidates we may develop. In addition, if we are able to progress through development and commercialization, we expect to be required to make milestone and royalty payments pursuant to various license or collaboration agreements with third parties. If we obtain regulatory approval for either of our leading candidates or any future product candidates, we also expect to incur significant commercialization expenses related to product manufacturing, marketing, sales, and distribution. Because the outcome of any clinical trial or preclinical study is highly uncertain, we cannot reliably estimate the actual amount of capital necessary to successfully complete the development and commercialization of either of our leading candidates or any future product candidates. Furthermore, following the completion of this offering, we expect to incur additional costs associated with operating as a public company.

Based on our current operating plan, we believe that the net proceeds from this offering, together with our existing cash, will be sufficient to fund our operations through 2026, including funding our working capital needs and a Phase 2 study for STAR-LLD in MM and a Phase 1 study in CLL. We have based these estimates on assumptions that may prove to be wrong, and we could use our capital resources sooner than we currently expect. Our operating plans and other demands for our cash resources may change as a result of many factors currently unknown to us, and we may need to seek additional funds sooner than planned.

The net proceeds of this offering, together with our existing capital, may not be sufficient to complete the development of either of our leading candidates in any form, or any future product candidates, and after this offering, we will require substantial capital in order to advance such development efforts for either of our leading candidates

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and any future product candidates through clinical trials, regulatory approval and commercialization. Accordingly, we will need to obtain substantial additional funding in connection with our continuing operations. Our ability to raise additional funds may be adversely impacted by global economic conditions, disruptions to, and volatility in, the credit and financial markets in the United States and worldwide, and diminished liquidity and credit availability. If the equity and credit markets deteriorate, it may make any necessary debt or equity financing more difficult, more costly and more dilutive. If we are unable to raise capital when needed or on attractive terms, we could be forced to delay, reduce or eliminate our research and development programs or any future commercialization efforts, or even cease operations. We expect to finance our cash needs through public or private equity or debt financings or other capital sources, including potential collaborations, licenses, and other similar arrangements. In addition, we may seek additional capital due to favorable market conditions or strategic considerations even if we believe we have sufficient funds for our current or future operating plans. Attempting to secure additional financing may divert our management from our day-to-day activities, which may adversely affect our ability to develop either of our leading candidates or any future product candidates.

Our future capital requirements will depend on many factors, including without limitation:

• the initiation, type, number, scope, progress, expansions, results, costs and timing of clinical trials and preclinical studies of either of our leading candidates and any future product candidates we may choose to pursue, including the costs of modification to clinical development plans (including an increase in the number, size, duration and/or complexity of a trial) based on feedback that we may receive from regulatory authorities and any third-party products used as combination agents in our clinical trials;

• the costs and timing of manufacturing for either of our leading candidates or any future product candidate, including commercial manufacturing at sufficient scale and encountering higher than expected costs to manufacture our current and future active pharmaceutical ingredients, if any product candidate is approved, including as a result of inflation, any supply chain issues or component shortages;

• slower than expected progress in developing either of our leading candidates or a future product candidate, including without limitation, additional costs caused by such program delays;

• the costs, timing and outcome of regulatory meetings and reviews of either of our leading candidates and developing certain formulations of either of our leading candidates or any future product candidates in any jurisdictions in which we or our current or any future collaborators may seek approval for either of our leading candidates or any future product candidates;

• our efforts to enhance operational systems and hire additional personnel to satisfy our obligations as a public company, including enhanced internal control over financial reporting;

• the timing and payment of milestone, royalty or other payments we must make pursuant to our existing and potential future license or collaboration agreements with third parties;

• the costs and timing of establishing or securing sales and marketing capabilities and commercial compliance programs if either of our leading candidates or any future product candidate is approved;

• higher than expected personnel, consulting or other costs, such as adding personnel or industry expert consultants or pursuing the licensing/acquisition of additional assets;

• higher than expected costs to obtain, maintain, enforce and protect our patents and other intellectual property and proprietary rights;

• our ability to achieve sufficient market acceptance, coverage and adequate reimbursement from third-party payors and adequate market share and revenue for any approved products;

• our ability and strategic decision to develop future product candidates other than either of our leading candidates, and the timing of such development, if any;

• patients’ willingness to pay out-of-pocket for any approved products in the absence of coverage and/or adequate reimbursement from third-party payors;

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• the terms and timing of establishing and maintaining collaborations, licenses and other similar arrangements; and

• our ability to raise sufficient funds when and if required.

Conducting clinical trials and preclinical studies and potentially identifying future product candidates is a time-consuming, expensive, and uncertain process that takes years to complete, and we may never generate the necessary data or results required to obtain regulatory approval and commercialize either of our leading candidates or any future product candidates. If approved, either of our leading candidates and any future product candidates may not achieve commercial success. We expect that our commercial revenue, if any, will initially be derived from sales of either of our leading candidates, which we do not expect to be commercially available for several years, if at all. Commercial success in the United States may depend upon acceptance and coverage by federal healthcare program and third-party payors, and it can be time consuming and costly to demonstrate that any of our products should be covered.

Accordingly, we will need to continue to rely on additional financing to achieve our business objectives. Adequate additional financing may not be available to us on acceptable terms, or at all, including as a result of financial and credit market deterioration or instability, market-wide liquidity shortages, geopolitical events or otherwise.

We may not be able to raise enough capital to fund our operations for the long term.

There can be no assurance that the offering will yield sufficient proceeds to provide enough funding to support its operations for the long term. We may not be able to raise additional debt or equity financing on favorable terms or at all going forward.

If we are unable to successfully develop or commercialize new products, or to do so on a timely or cost effective basis, our operating results will suffer.

Developing and commercializing a new product is time consuming and costly and is subject to numerous factors that may delay or prevent development and commercialization. Our future results of operations will depend to a significant extent upon our ability to successfully gain FDA approval of and commercialize new products in a timely and cost effective manner. There are numerous difficulties in developing and commercializing new products, including:

• The ability to develop products in a timely and cost effective manner and in compliance with regulatory requirements;

• The success of the pre-clinical and clinical testing processes to ensure that new products are safe and effective or chemically identical and bioequivalent to the branded reference listed drug;

• The risk that any of our products presently under development, if and when fully developed and tested, will not perform as expected;

• Delays or unanticipated costs, including delays associated with the completion of clinical trials for our branded products;

• Delays associated with FDA registration, listing and approval processes and the ability to obtain in a timely manner, and maintain, required regulatory approvals;

• Legal actions against our products brought by brand competitors, and legal challenges to our branded products or branded product intellectual property;

• The availability, on commercially reasonable terms, of raw materials, including API and other key ingredients;

• Our ability to scale up manufacturing methods to successfully manufacture commercial quantities of products in compliance with regulatory requirements; and

• Acceptance of our products by physicians, patients, payors and the healthcare community.

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As a result of these and other difficulties, products currently in development may or may not receive necessary regulatory approvals on a timely basis or at all and we may not succeed in effectively managing our development costs. Further, if we are required by the FDA or any equivalent foreign regulatory authority to complete clinical trials in addition to those we currently expect to conduct, to repeat a clinical trial that has already been completed, or if there are any delays in completing preclinical studies, filing an investigational new drug application, or completing clinical trials, our expenses could increase. This risk exists particularly with respect to the introduction of branded products because of the uncertainties, higher costs, and lengthy time frames associated with research and development of such products and the inherent unproven market acceptance of such products.

Our future profitability depends, in part, upon our ability to introduce, on a timely basis, new products.

The timeliness of our product introductions is dependent upon, among other things, the timing of regulatory approval of our products, which to a large extent is outside of our control, as well as the timing of competing products. As additional suppliers introduce comparable pharmaceutical products, price competition intensifies, market access narrows and product sales prices and gross profit percentage decline, often significantly and rapidly. Accordingly, our total revenues and future profitability are dependent, in part, upon our ability to file NDA’s with the FDA and gain approvals timely and effectively. No assurances can be given that we will be able to develop and introduce successful products in the future within the time constraints necessary to be successful. If we are unable to continue to timely and effectively file NDA’s with the FDA, our total revenues, gross profit percentage, and operating results may decline significantly, and our prospects and business may be materially adversely affected.

If any of our products, when developed and approved, cannot be successfully or timely commercialized, our operating results could be adversely affected. We cannot guarantee that any investment we make in developing products will be recouped, even if we are successful in commercializing those products.

We will need to expend a significant amount of resources on research and development, which may not lead to successful product introductions.

We expend resources on research and development primarily to enable us to manufacture and market FDA approved products in accordance with FDA regulations. As we continue to develop new products, we will likely incur increased research, development and licensing expenses. Because of the inherent risk associated with research and development efforts in our industry, our research and development expenditures may not result in the successful introduction of new FDA approved products. Also, after we submit an NDA, the FDA may request that we conduct additional clinical trials for an NDA and conduct post-marketing surveillance of our products if approved. Although manufacturing for our products uses well established technologies, we may encounter delays or technology barriers that delay or even make our products unviable. As a result, we may be unable to reasonably determine the total research, development, and manufacturing costs required to develop a particular product. Finally, we cannot be certain that any investment made in developing products will be recovered, even if we are successful in commercializing the product. To the extent that we expend significant resources on research and development efforts and are not ultimately able to introduce successful new products as a result of those efforts or cost effectively commercialize new products, our business, financial position and results of operations may be materially adversely affected.

We will incur operating losses for the foreseeable future.

Our net loss was approximately $9.5 million and $15.0 million for the years ended March 31, 2025 and 2024, respectively. Our net losses may fluctuate significantly from quarter to quarter and year to year.

We devote significant amounts of financial resources to the research and development of our preclinical and clinical programs. We may incur significant expenses in the future. Some of these expenses will be made in connection with our ongoing activities, as we:

• Launch new products into the marketplace;

• Conduct clinical trials and seek regulatory approval for products;

• Continue development of our pipeline product candidates;

• Conduct preclinical studies for product candidates;

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• Add personnel to continue clinical and preclinical product development efforts; and

• Continue our research and development efforts for new product opportunities, including business development and acquisitions.

To become profitable, we must succeed in developing or acquiring products, obtaining regulatory approval for them, and manufacturing, marketing, and selling those products for which we may obtain regulatory approval. Even if we achieve profitability for any period in the future, we may not be able to sustain profitability in subsequent periods. Our failure to become profitable would depress our market value and could impair our ability to raise capital, expand our business, discover, or develop other products or continue our operations. A decline in the value of our company could cause you to lose all or part of your investment.

We face intense competition from development companies including startups and large pharmaceutical companies that could limit or even make obsolete our market objectives. This could significantly limit our growth and materially adversely affect our financial results.

The pharmaceutical industry is highly competitive. The principal competitive factors in the pharmaceutical industry include:

• Introduction of other brand or generic drug manufacturers’ products in direct competition with our products;

• Ability of generic competitors to quickly enter the market after the expiration of patents or exclusivity periods, diminishing the amount and duration of significant profits;

• Company’s reputation as a manufacturer and distributor of quality products;

• Product appearance and labeling; and

• A company’s breadth of potential product offerings.

We face, and will continue to face, competition from pharmaceutical, biopharmaceutical, and biotechnology companies developing similar products and technologies. Many of our competitors have longer operating histories and greater financial, research and development, marketing, and other resources than we do. Consequently, many of our competitors may be able to develop products or processes competitive with, or superior to, our own. Furthermore, we may not be able to differentiate our products from those of our competitors, to successfully develop or introduce new products, on a timely basis or at all, that are less costly than those of our competitors, or to offer payment and other commercial terms to customers as favorable as those offered by our competitors. The markets in which we compete and intend to compete are undergoing, and are expected to continue to undergo, rapid and significant change. We expect competition to intensify as technological advances and consolidations continue. New developments by other manufacturers and distributors could render our products uncompetitive or obsolete.

Our branded pharmaceutical expenditures may not result in commercially successful products.

We have made significant investments in the development of branded products. We cannot be certain that these development costs will result in the successful development or launch of branded products or will improve the long term profitability of our business. While we endeavor (with our relevant development and manufacturing partners, as applicable) to protect our branded assets by incorporating specialized manufacturing processes and by securing regulatory exclusivities and intellectual property protections, such exclusivities and protections can be subject to legal challenges that might result in a reduction of the exclusivity period or a loss of exclusivity.

We continue to expand our product line. The success of our branded products will be based largely on the successful identification and future development of our product opportunities. We cannot be certain that our branded product expenditures will result in successful research and development of our products leading to the commercially successful launches of these products or will improve the long term profitability of our business.

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A business interruption at our contract manufacturing facilities or at lab facility operated by a related party that we rely on could have a material adverse effect on our business, financial condition, and results of operations.

We produce all of the products we use in research and development at contract manufacturing facilities. These facilities, or the related party lab facility that we rely on for the development, could be subject to earthquakes, power shortages, telecommunications failures, floods, hurricanes, typhoons, fires, extreme weather conditions, medical epidemics and other natural or manmade disasters, or FDA interventions, or business interruptions. A significant disruption at any of these facilities, even on a short term basis, could impair our ability to produce and develop products on a timely basis, which could have a material adverse effect on our business, financial condition, and results of operations.

We depend to a large extent on third-party suppliers for the raw materials for our products, particularly the chemical compounds comprising the API used in the research and development of our products. Although there are multiple sources of these API’s a prolonged interruption in the supply of such products could have a material adverse effect on our business, financial position, and results of operations.

We may purchase raw materials, including API from both U.S. and non-U.S. companies. If we experience supply interruptions or delays, we may have to obtain substitute materials or products, which in turn would require us to obtain amended or additional regulatory approvals, subjecting us to additional expenditures of significant time and resources. We may source raw materials or API from a single source, which increases the risk to our business if supply from that source is interrupted.

In addition, changes in our raw material suppliers, including suppliers of API, could result in significant delays in production and higher raw material costs, because regulatory authorities must generally approve raw material sources for pharmaceutical products, which may be time consuming. Any significant supply interruption could have a material adverse effect on our business, research and development programs, financial condition, prospects, and results of operations. Because the federal drug approval application process requires specification of raw material suppliers, if raw materials from a specified supplier were to become unavailable, FDA approval of a new supplier may be required. A delay in the manufacture and marketing of the drug involved while a new supplier becomes approved by the FDA and its manufacturing process is determined to meet FDA standards could, depending on the particular product, have a material adverse effect on our results of operations and financial condition. Generally, we attempt to mitigate the potential effects of any such situation by providing for, where economically and otherwise feasible, two or more suppliers of raw materials for the drugs that we manufacture. In addition, we may attempt to enter into a contract with a raw material supplier in an effort to ensure adequate supply for certain of our products.

Further, purchasing raw materials from non-U.S. companies involves numerous factors and uncertainties beyond our control including increased shipping costs, the imposition of additional import or trade restrictions, increased custom duties and tariffs, unforeseen delays in customs, currency exchange rates, transportation delays, foreign government regulations, political instability and economic uncertainties in the countries from which we purchase our raw materials. These and other issues affecting our non-U.S. suppliers could have a material adverse effect on our business, financial condition, and results of operations.

Our future success depends on our ability to attract and retain key employees and consultants.

Our future success depends, to a substantial degree, upon the continued service of the key members of our management team. These include Pedro Lichtinger Waisman, Chairman and CEO, Scott Kahn, Chief Financial Officer, Jamie Oliver, Chief Medical Officer, Rod Hartwig, Vice President Research and Development and Manufacturing, and Shannon Wisniewski, Executive Director of Business Development and Program Management. The loss of the services of key members of our management team, or their inability to perform services on our behalf, could have a material adverse effect on our business, financial condition, prospects, and results of operations. Our success also depends, to a large extent, upon the contributions of the staff within our lab facility operated by a related party. We compete for qualified personnel against other biotechnology companies that may offer more favorable employment or contract opportunities. If we are not able to attract and retain the necessary personnel to accomplish our business objectives, we could experience constraints that would adversely affect our ability to support our research and development programs. Although we believe that we have been successful in attracting and retaining skilled personnel in all areas of our business, we cannot provide assurance that we can continue to attract, train and retain such personnel. Any failure in this regard could limit our ability to develop new products. We do not have key person insurance on any of our key employees or consultants.

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We depend on our ability to protect our intellectual property and proprietary rights. We may not be able to keep our intellectual property and proprietary rights confidential and protect such rights.

Our success depends on our ability to protect and defend the intellectual property rights associated with our current and future product opportunities. If we fail to protect our intellectual property adequately, competitors may develop, manufacture and market products similar to, or that may be confused with, our products, and our competitors may obtain regulatory approval to make and distribute other versions of our products. We cannot be certain that patents will be issued with respect to any of our patent applications or that any existing or future patents issued to or licensed by us will provide competitive advantages for our products or will not be challenged, invalidated, circumvented, or held unenforceable in proceedings commenced by our competitors or other third parties. Furthermore, our patent rights may not prevent or limit our present and future competitors from developing, making, importing, using, or commercializing products that are functionally similar to our products. Some of our products, including some of our promoted products, are not protected by patents at all.

We also rely particularly on trade secrets, unpatented know-how and proprietary expertise and continuing innovation to develop and maintain our competitive position. We generally enter into confidentiality agreements with licensees, suppliers, employees, consultants, and other parties. This is done in part because not all our products are protected by patents. We cannot provide assurance that these agreements will not be breached. We also cannot be certain that we will have recourse to adequate remedies in the event of a breach. Disputes may arise concerning the ownership of intellectual property or the applicability of confidentiality agreements. We cannot be sure that our trade secrets and proprietary platform will not be independently developed or otherwise become known by our competitors or, if patents are not issued with respect to internally developed products, if we will be able to maintain the confidentiality of information relating to these products. Efforts to enforce our intellectual property rights can be costly, time consuming, and ultimately unsuccessful. Any failure to adequately prevent disclosure of our know-how, trade secrets and other propriety information could have a material adverse impact on our business and our prospects.

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

The patent position of companies in the pharmaceutical industry generally involves complex legal and factual questions and has been and remains the subject of significant litigation in recent years. Legal standards relating to scope and validity of patent claims are evolving and may differ in various countries. Patent protection must ultimately be sought on a country-by-country basis, which is an expensive and time-consuming process with uncertain outcomes. Any patents we have obtained, or may obtain in the future, may be challenged, invalidated, or circumvented. As a result, the issuance, scope, validity, enforceability, and commercial value of our patent rights are highly uncertain. We may be involved in lawsuits to protect or enforce our patents or the patents of our licensors, which could be expensive, time consuming and unsuccessful.

Proceedings to enforce patent rights could: result in substantial costs and divert our efforts and attention from other aspects of our business; put our patents at risk of being invalidated or interpreted narrowly; put our patent applications at risk of not issuing; and provoke third parties to assert claims against us. We may not prevail in any lawsuits that we initiate, and the damages or other remedies awarded to us, if any, may not be commercially meaningful. Accordingly, our efforts to enforce our intellectual property rights around the world may be inadequate to obtain a significant commercial advantage.

Obtaining and maintaining our patent protection depends on compliance with various procedural, document submission, fee payment and other requirements imposed by governmental patent agencies, and our patent protection could be reduced or eliminated for non-compliance with these requirements.

Periodic maintenance and annuity fees on any issued patent are due to be paid to the PTO and foreign patent agencies in several stages over the lifetime of the patent. The PTO and various foreign governmental patent agencies require compliance with a number of procedural, documentary, fee payment and other similar provisions during the patent application process. While an inadvertent lapse may, in many cases, be cured by payment of a late fee or by other means in accordance with the applicable rules, there are situations in which noncompliance can result in abandonment or lapse of the patent or patent application, resulting in partial or complete loss of patent rights in the relevant jurisdiction. Non-compliance events that could result in abandonment or lapse of a patent or patent application include failure to respond to official actions within prescribed time limits, nonpayment of fees and failure to properly

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prepare and submit formal documents. If we or our licensors fail to maintain the patents and patent applications covering our products or product candidates, our competitors might be able to enter the market, which would harm our business, prospects, and financial position.

Our competitors or other third parties may allege that we, our suppliers, or partners are infringing their intellectual property, forcing us to expend substantial resources in litigation, the outcome of which is uncertain. Any unfavorable outcome of such litigation, including losses related to “at risk” product launches, could have a material adverse effect on our business, financial position, and results of operations.

Pharmaceutical, biotechnology and development startups are ready to enforce their intellectual property protection from entities selling or seeking regulatory approval to manufacture and market generic or other copies of their branded products, or products related to their branded products or technologies. These companies or other patent holders, including patent holders who do not have related products, may allege patent infringement or other violations of intellectual property rights. Patent holders may also bring patent infringement suits against companies that are currently marketing and selling an approved product, including an approved generic product. Litigation often involves significant expense and can delay or prevent introduction or sale of our generic or other products. For example, a certain period of delay may be statutorily prescribed, or a court could grant a patent holder injunctive relief for the period of the litigation. If third party patents are held valid, enforceable, and infringed by our products, we may, unless we could obtain a license from the patent holder, need to delay selling our corresponding product, pay damages, and, if we are already selling our product, cease selling and potentially destroy existing product stock. These risks apply to our product candidates. Third parties, including our competitors, may allege that one of our product candidates violates their patent rights, which would expose us to the same risks. A license may not be available from the patent holder on commercially reasonable terms, or at all. If available, we may choose to take a license under a third party’s patent rights to resolve a dispute, even in the absence of a finding by a court that a patent is valid, enforceable, and infringed.

There may be situations in which we may make business and legal judgments to manufacture, market or sell products that are subject to claims of alleged patent infringement prior to final resolution of those claims by the courts, based upon our belief that such patents are invalid, unenforceable, or are not infringed by our manufacturing, marketing, and sale of such products. This is referred to in the pharmaceutical industry as an “at risk” launch. The risk involved in an at risk launch can be substantial because, if a patent holder ultimately prevails against us, the remedies available to such holder may include, among other things, permanent injunctive relief preventing the sale of the product and damages measured as a reasonable royalty or by the profits lost by the patent holder, which can be significantly higher than the profits we make from selling our product. We could face substantial damages from adverse court decisions in such matters. We could also be at risk for the value of such inventory that we are unable to market or sell.

We may be subject to claims by third parties asserting that we or our employees have misappropriated their intellectual property or claiming ownership of what we regard as our own intellectual property.

We may be subject to claims that our employees or we have inadvertently or otherwise used intellectual property, including trade secrets or other proprietary information, of any such employee’s former employer. We may also in the future be subject to claims that we have caused an employee to breach the terms of his or her non-competition or non-solicitation agreement. Litigation may be necessary to defend against these potential claims.

In addition, while it is our policy to require our employees and contractors who may be involved in the development of intellectual property to execute agreements assigning such intellectual property to us, such employees and contractors may breach the agreement and claim the developed intellectual property as their own.

If we fail in prosecuting or defending any such claims, in addition to paying monetary damages, we may lose valuable intellectual property rights or personnel. A court could prohibit us from using technologies or features that are essential to our products if such technologies or features are found to incorporate or be derived from the trade secrets or other proprietary information of the former employers. Even if we are successful in prosecuting or defending against such claims, litigation could result in substantial costs and could be a distraction to our management team. In addition, any litigation or threat thereof may adversely affect our ability to hire employees or contract with independent service providers. Moreover, a loss of key personnel or their work product could hamper or prevent our ability to commercialize our products.

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We are increasingly dependent on information technology, and our systems and infrastructure face certain risks, including cybersecurity and data leakage risks.

Significant disruptions to our information technology systems or breaches of information security could adversely affect our business. In the ordinary course of business, we collect, store, and transmit large amounts of confidential information, and it is critical that we do so in a secure manner to maintain the confidentiality and integrity of such confidential information. The size and complexity of our information technology systems, and those of our third party vendors with whom we contract, make such systems potentially vulnerable to service interruptions and security breaches from inadvertent or intentional actions by our employees, partners, or vendors, from attacks by malicious third parties, or from intentional or accidental physical damage to our systems infrastructure maintained by us or by third parties. Maintaining the secrecy of this confidential, proprietary, or trade secret information is important to our competitive business position. While we have taken steps to protect such information and invested in information technology, there can be no assurance that our efforts will prevent service interruptions or security breaches in our systems or the unauthorized or inadvertent wrongful use or disclosure of confidential information that could adversely affect our business operations or result in the loss, dissemination, or misuse of critical or sensitive information. A breach of our security measures or the accidental loss, inadvertent disclosure, unapproved dissemination, misappropriation or misuse of trade secrets, proprietary information, or other confidential information, whether as a result of theft, hacking, fraud, trickery, or other forms of deception, or for any other reason, could enable others to produce competing products, use our proprietary technology or information, or adversely affect our business or financial condition. Further, any such interruption, security breach, loss, or disclosure of confidential information, could result in financial, legal, business, and reputational harm to us and could have a material adverse effect on our business, financial position, results of operations or cash flow. See also our “Risk Factor” below entitled “We and our service providers may be subject to a variety of privacy and data security laws and contractual obligations, which could increase compliance costs, and our actual or perceived failure to comply with such laws and obligations could subject us to potentially significant liability, fines or penalties and otherwise harm our business.”

Our ability to use our net operating loss carryforwards to offset future taxable income may be subject to certain limitations.

Our NOLs, and certain other tax attributes could expire unused and be unavailable to reduce future income tax liabilities because of their limited duration or because of restrictions under U.S. tax law. As of March 31, 2025 and 2024, we had NOLs of approximately $36.7 million and $35.4 million, respectively, for federal, and $36.2 million and $29.8 million, respectively, for state income tax purposes. Our federal NOLs do not expire; however, they are only available to offset up to 80% of taxable income for the year they are carried forward to. Our state NOLs begin to expire during the years 2037 through 2043. In addition, as of March 31, 2025 and 2024, we had Canadian NOLs of approximately $2.1 million and $2.0 million, which begin to expire during the years 2037 through 2043. In addition to our NOLs we have U.S. research tax credit carryforwards of approximately $2.4 million, which expire during the years 2037 through 2043.

Under TCJA, federal NOLs generated in tax years ending after December 31, 2017 may be carried forward indefinitely. Under the CARES Act, NOLs carryforwards arising in tax years beginning after December 31, 2017 and before January 1, 2021 may be carried back to each of the 5 tax years preceding the tax year of such loss. Due to our cumulative losses, we do not anticipate that such provision of the CARES Act will be relevant to us. The deductibility of federal NOLs, particularly for tax years beginning after December 31, 2020, may be limited. It is uncertain if and to what extent various states will conform to TCJA or the CARES Act.

In addition, our NOLs are subject to review and possible adjustment by the IRS and state tax authorities. In general, under Sections 382 and 383 of the Code, a corporation that undergoes an “ownership change” is subject to limitations on its ability to use its pre-change NOLs to offset future taxable income. Ownership changes as defined under Sections 382 and 383 will affect our ability to use our NOLs and tax credits in future years. Furthermore, our ability to use the NOLs and credits of companies that we may acquire in the future may also be subject to the same use limitations. For these reasons, we may or may not be able to use a material portion of business credits and state NOLs prior to their statutory expiration, even if we attain profitability.

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We and our manufacturing partners are subject to extensive governmental regulation, and we face significant uncertainties and potentially significant costs associated with our efforts to comply with applicable regulations. Any noncompliance may result in fines or other sanctions, including debarment, product seizures, product recalls, injunctive actions, and criminal prosecutions, which could result in material adverse effects to our business, financial position, and results of operations.

The pharmaceutical industry operates in a highly regulated environment subject to the actions of courts and governmental agencies that influence the ability of a company to successfully operate its business and is subject to regulation by various governmental authorities at the federal, state and local levels with respect to the development, manufacture, labeling, sale, distribution, marketing, advertising and promotion of pharmaceutical products. As a continuous delivery startup, we are subject to extensive regulations by the federal government, principally the FDA and the DEA as well as by state governments.

The FDC Act and other federal, state, and local statutes and regulations govern the testing, manufacture, safety, labeling, storage, disposal, tracking, recordkeeping, approval, advertising, and promotion (including to the healthcare community) of our product candidates. If we, our products, the manufacturing facilities for our products, our CROs, or other persons or entities working on our behalf fail to comply with applicable regulatory requirements either before or after marketing approval, a regulatory agency, such as the FDA, may, depending on the stage of product development and approval, revoke, withdraw, or suspend approvals of previously approved products for cause, debar companies and individuals from participating in the drug approval process, request or in certain circumstances mandate recalls of allegedly violative products, seize allegedly violative products, issue Warning Letters or Untitled Letters, mandate modifications to promotional materials or require the provision of corrective information to healthcare practitioners, amend and update labels or package inserts, suspend or terminate any ongoing clinical trials, refuse to approve pending applications or supplements to applications filed, refuse to allow entry into government contracts, obtain injunctions to close manufacturing plants allegedly not operating in conformity with FDA’s cGMP requirements, stop shipments of allegedly violative products, impose import restrictions on any ingredients or components, including any APIs, that are imported from outside the U.S., impose fines perhaps significant in amount, require entry into a consent decree, which can include imposition of various fines, reimbursements for inspection costs, required due dates for specific actions and penalties for noncompliance and other sanctions imposed by courts or regulatory bodies, including criminal prosecutions. 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 facility where the product is manufactured, a regulatory agency may impose restrictions relative to that product or the manufacturing facility, including requiring product recall, notice to physicians, withdrawal of the product from the market or suspension of manufacturing.

We also cannot predict the likelihood, nature or extent of adverse government regulation that may arise from pending or future legislation or administrative action, either in the U.S. or abroad. Because of these adverse government actions our business may be negatively impacted, and if we are not able to achieve and maintain regulatory compliance, we may not be permitted to market our products or product candidates, which would adversely affect our ability to generate revenues and achieve or maintain profitability.

We are subject to extensive environmental laws and regulation, and we face significant uncertainties and potentially significant costs associated with our efforts to comply with applicable regulations.

Because of the chemical ingredients of pharmaceutical products and the nature of the manufacturing process, the pharmaceutical industry is subject to extensive environmental laws and regulation and the risk of incurring liability for damages and the costs of remedying environmental problems. These requirements include regulation of the handling, manufacture, transportation, storage, use and disposal of materials, including the discharge of hazardous materials and pollutants into the environment. In the normal course of our business, we are exposed to risks relating to possible releases of hazardous substances into the environment, which could cause environmental or property damage or personal injuries, and which could result in (i) our noncompliance with such environmental and occupational health and safety laws and regulations and (ii) regulatory enforcement actions or claims for personal injury and property damage against us. If an unapproved or illegal environmental discharge or accident occurred or if we were to discover contamination caused by prior operations, including by prior owners and operators of properties we acquire, then we could be liable for cleanup, damages, or fines, which could have a material adverse effect on our business, financial position, results of operations and cash flow. In the future, we may be required to increase expenditures in order to remedy environmental problems or comply with changes in applicable environmental laws and regulations. We could also become a party to environmental remediation investigations and activities. These obligations may relate to sites

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that we currently or in the future may own or lease, sites that we formerly owned or operated, or sites where waste from our operations was disposed. Additionally, if we fail to comply with environmental regulations to use, discharge or dispose of hazardous materials appropriately or otherwise to comply with the provisions of our operating licenses, the licenses could be revoked, and we could be subject to criminal sanctions or substantial civil liability or be required to suspend or modify our manufacturing operations. We currently operate from our leased space in New Jersey and we are required to comply with the laws and regulations of New Jersey in addition to any federal laws and regulations. We may in the future establish or acquire operations in other U.S. and/or overseas jurisdictions subject to equally or more stringent laws and regulations. We may in the future establish or acquire operations in other jurisdictions subject to equally or more stringent laws and regulations. Stricter environmental, safety and health laws and enforcement policies could result in substantial costs and liabilities to us, and could subject our handling, manufacture, use, reuse or disposal of substances or pollutants to more rigorous scrutiny than is currently the case. Consequently, compliance with these laws could result in significant capital expenditures, as well as other costs and liabilities, which could materially adversely affect us.

These risks, along with others, have the potential to materially and adversely affect our business, financial position, results of operations and prospects. Although we have developed compliance programs to address the regulatory environment, there is no guarantee that these programs will meet regulatory agency standards now or in the future. Additionally, despite our efforts at compliance, there is no guarantee that we may not be deemed to be deficient in some manner in the future. If we are deemed to be deficient in any significant way, our business, financial position, and results of operations could be materially affected.

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

The time required to obtain approval by the FDA and comparable foreign authorities is unpredictable and typically takes many years following the commencement of clinical trials and depends upon numerous factors, including the substantial discretion of the regulatory authorities. In addition, approval policies, regulations or the type and amount of clinical data necessary to gain approval may change during the course of a product candidate’s clinical development and may vary among jurisdictions.

Our product candidates could fail to receive regulatory approval for many reasons. For example:

• The FDA or comparable foreign regulatory authorities may disagree that our product candidates meet the criteria for the NDA or ANDA regulatory pathway or foreign regulatory pathways;

• We may be unable to demonstrate to the satisfaction of the FDA or comparable foreign regulatory authorities that a product candidate is safe and effective or chemically identical and bioequivalent to its branded reference product for its proposed indication;

• The results of any clinical trials we conduct may not meet the level of statistical significance required by the FDA or comparable foreign regulatory authorities for approval;

• We may be unable to demonstrate that a product candidate’s clinical and other benefits outweigh its safety risks;

• The FDA or comparable foreign regulatory authorities may fail to approve the manufacturing processes or facilities of third party manufacturers with which we contract for clinical and commercial supplies; and

• The approval policies or regulations of the FDA or comparable foreign regulatory authorities may change significantly in a manner rendering our clinical data insufficient for approval.

This lengthy approval process as well as the unpredictability of future clinical trial results may result in our failing to obtain regulatory approval to market certain of our product candidates, which would harm our business, results of operations and prospects significantly. In addition, even if we obtain approval for our product candidates, regulatory authorities may approve any of our product candidates for fewer or more limited indications than we request or may grant approval contingent on the performance of costly post marketing clinical trials or may approve a product candidate with a label that does not include the labeling claims necessary or desirable for the successful commercialization of that product candidate. Any of the foregoing scenarios could harm the commercial prospects for our product candidates.

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Any of these events could prevent us from achieving or maintaining market acceptance of the affected product or product candidate and could substantially increase the costs of commercializing our products and product candidates.

If we are found to have improperly promoted our products, we may be subject to restrictions on the sale or marketing of our products and significant fines, penalties and sanctions, and our image and reputation within the industry and marketplace could be harmed.

The FDA and other regulatory agencies, including regulatory authorities outside the U.S., strictly regulate the marketing and promotional claims that are made about drug products. In particular, promotion for a product must be balanced, truthful, non-misleading, and consistent with its labeling approved by the FDA or by regulatory agencies in other countries. We cannot prevent physicians from prescribing our products for indications or uses that are inconsistent with the approved package insert. If, however, we are found to have promoted such unapproved uses prior to the FDA’s approval for an additional indication, we may, among other consequences, receive Untitled or Warning Letters and become subject to significant liability, including False Claims Act liability, which would materially harm our business. Both the U.S. federal government and foreign regulatory authorities have levied significant civil and criminal fines against companies and individuals for alleged improper promotion and have entered into settlement agreements with pharmaceutical companies to limit inappropriate promotional activities. If we become the target of such an investigation or prosecution based on our marketing and promotional practices, we could face similar sanctions, which would materially harm our business. In addition, management’s attention could be diverted from our business operations, significant legal expenses could be incurred, and our reputation could be damaged.

Manufacturing or quality control problems may damage our reputation for quality production, require costly remedial activities and negatively impact our business, results of operations, and financial condition.

As a continuous delivery startup, we are subject to substantial regulation by various governmental authorities. For instance, we must comply with requirements of the FDA and other healthcare regulators with respect to the manufacture of pharmaceutical products. We must register our facilities, whether located in the U.S. or elsewhere, with the FDA as well as regulators outside the U.S. Also, our products, including our investigational products, must be made in a manner consistent with applicable cGMP regulations, or similar standards in each territory in which we manufacture. The failure of one of our facilities, or a facility of one of our third party suppliers, to comply with applicable laws and regulations may lead to breach of representations made to our customers or to regulatory or government action against us related to products made in that facility.

Our employees and independent contractors, including consultants, vendors and any third parties we may engage in connection with development and commercialization may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements, which could harm our business.

Misconduct by our employees and independent contractors, including consultants, vendors and any third parties we may engage in connection with development and commercialization, could include intentional, reckless or negligent conduct or unauthorized activities that violate: (i) the laws and regulations of the FDA and other similar regulatory authorities, including those laws that require the reporting of true, complete and accurate information to such authorities; (ii) manufacturing standards; (iii) data privacy, security, fraud and abuse and other healthcare laws and regulations; or (iv) laws that require the reporting of true, complete and accurate financial information and data. Specifically, sales, marketing and business arrangements in the healthcare 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 and promotion, sales commission, customer incentive programs and other business arrangements. Activities subject to these laws could also involve the improper use or misrepresentation of information obtained in the course of clinical trials, creation of fraudulent data in preclinical studies or clinical trials or illegal misappropriation of drug product, which could result in regulatory sanctions and cause serious harm to our reputation. It is not always possible to identify and deter misconduct by employees and other third parties, and the precautions we take to detect and prevent this activity may not be effective in controlling unknown or unmanaged risks or losses or in protecting us from governmental investigations or other actions or lawsuits stemming from a failure to comply with such laws or regulations. Additionally, we are subject to the risk that a person or government could allege such fraud or other misconduct, even if none occurred. If any such actions are instituted against us, and we are not successful in defending ourselves or asserting our rights, those actions could have a significant impact on our business and results of operations.

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Risks Related to Development, Clinical Testing, Manufacturing, and Regulatory Approval

Results of preclinical studies, early clinical trials, or analyses may not be indicative of results obtained in later trials, and even if we complete all planned clinical trials in the future, there is no guarantee that at the time of submission the FDA will accept our new drug application (NDA).

The results of preclinical studies, early and mid-stage clinical trials or analyses of our product candidates may not be predictive of the results of later-stage clinical trials. Product candidates in later stages of clinical trials may fail to show the desired safety and efficacy traits despite having progressed through preclinical studies and initial clinical trials. A number of companies in the biotechnology industry have suffered significant setbacks in advanced clinical trials due to lack of efficacy or adverse safety profiles, notwithstanding promising results in earlier trials. In addition, conclusions based on promising data from analyses of clinical results may be shown to be incorrect when implemented in prospective clinical trials.

In the U.S., we are not permitted to market our product candidates until we receive regulatory approval of an NDA from the FDA. The process of obtaining such regulatory approval is expensive, often takes many years following the commencement of clinical trials and can vary substantially based upon the type, complexity and novelty of the product candidates involved, as well as the target indications and patient population. Approval policies or regulations may change, and the FDA and comparable regulatory authorities have substantial discretion in the approval process, including the ability to delay, limit or deny approval of a product candidate for many reasons. Despite the time and expense invested in clinical development of product candidates, regulatory approval of a product candidate is never guaranteed. Of the large number of drugs in development, only a small percentage successfully complete the FDA or foreign regulatory approval processes and are commercialized.

Failures of or delays in clinical trials are common and have many causes, and such failures or delays could result in increased costs to us and could prevent or delay our ability to obtain regulatory approval and commence product sales for new products. We may also find it difficult to enroll patients in our clinical trials, which could delay or prevent development of our product candidates. Moreover, we can also find unexpected or unforeseen or unexpected side effects that can delay or make the product unviable.

We may experience failures of or delays in clinical trials of our product candidates. Our planned clinical trials may not begin on time, have an effective design, enroll a sufficient number of patients, or be completed on schedule, if at all and may not meet primary or secondary endpoints. Our clinical trials may fail or be delayed for a variety of reasons, including, among others: delays in obtaining regulatory approval to commence a trial; delays in reaching agreement with the FDA or equivalent foreign regulatory authorities on final trial design; imposition of a clinical hold for safety reasons or following an inspection of our clinical trial operations or trial sites by the FDA or other regulatory authorities; delays in reaching agreement on acceptable terms with prospective CROs, and clinical trial sites, or failure by such CROs to carry out the clinical trial at each site in accordance with the terms of our agreements with them; delays in obtaining required institutional review board approval at each site; difficulties or delays in having patients complete participation in a trial or return for post treatment follow up, or clinical sites electing to terminate their participation in one of our clinical trials, which would likely have a detrimental effect on subject enrollment; time required to add new clinical sites; or delays or failure by us or our contract manufacturers to produce and deliver sufficient supply of clinical trial materials.

In addition, identifying and qualifying patients to participate in clinical trials of our product candidates is critical to our success. The timing of our clinical trials depends on the speed at which we can recruit patients to participate in testing our product candidates as well as completion of required follow up periods. We may not be able to identify, recruit, and enroll a sufficient number of patients, or those with required or desired characteristics or to complete our clinical trials, in a timely manner. Patient enrollment and completion of the trials is affected by factors including: the severity of the disease under investigation; the design of the trial protocol; the size of the potential patient population; the eligibility criteria for the trial in question; the perceived risks and benefits of the product candidate under trial; the proximity and availability of clinical trial sites for prospective patients; the availability of competing therapies and clinical trials; efforts to facilitate timely enrollment in clinical trials; patient referral practices of physicians; acceptance of our delivery system by patients, and the ability to monitor patients adequately during and after treatment.

If we are unable to initiate or complete our planned clinical trials or any such clinical trial is delayed for any of the above reasons or other reasons, our development costs may increase, our regulatory approval process could fail or be delayed and our ability to commercialize and commence sales of our product candidates could be materially harmed, which could have a material adverse effect on our business.

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The testing required to support our clinical trials for the regulatory approval of our products is conducted primarily by independent third parties. Any failure by any of these third parties to perform this testing properly and in a timely manner may have an adverse effect upon our ability to obtain regulatory approvals.

Our applications for the regulatory approval of our products, incorporate the results of testing and other information that is conducted or gathered primarily by independent third parties (including, for example, manufacturers of raw materials, testing laboratories, CROs, or independent research facilities). Our ability to obtain and maintain regulatory approval of the products being tested is dependent, in part, upon the quality of the work performed by these third parties, the quality of the third parties’ facilities and the accuracy of the information provided by third parties. Our control over any of these factors may be limited. We rely on these parties for execution of our preclinical studies and clinical trials, and control only certain aspects of their activities. Nevertheless, we are responsible for ensuring that each of our trials is conducted in accordance with the applicable protocol, legal, regulatory and scientific standards and our reliance on the CROs does not relieve us of all of our regulatory responsibilities. We and our CROs are required to comply with FDA laws and regulations regarding cGCP guidelines for all of our products in clinical development. Regulatory authorities enforce GCP through periodic inspections of trial sponsors, principal investigators and trial sites.

If we or any of our CROs fail to comply with applicable GCP, the clinical data generated in our clinical trials may be deemed unreliable and the FDA or comparable foreign regulatory authorities may require us to perform additional clinical trials before approving our marketing applications. We also rely on contract laboratories and other third parties, such as CROs, to conduct or otherwise support our nonclinical laboratory studies properly and on time, which are subject to GLP requirements. We cannot assure you that upon inspection by a given regulatory authority, such regulatory authority will determine that any of our clinical trials comply with applicable GCP and GLP regulations. In addition, our clinical trials must be conducted with products produced under the FDA’s cGMP regulations. While we have agreements governing activities of our CROs, we have limited influence over their actual performance. In addition, portions of the clinical trials for our product candidates may be conducted outside of the U.S., which will make it more difficult for us to monitor CROs and perform visits of our clinical trial sites and will force us to rely heavily on CROs to ensure the proper and timely conduct of our clinical trials and compliance with applicable regulations, including GCP and GLP requirements.

Our products or product candidates may cause adverse effects or have other properties that could delay or prevent their regulatory approval or limit the scope of any approved package insert or market acceptance or result in significant negative consequences during development or following marketing approval.

Treatment with our products or product candidates may produce undesirable side effects or adverse reactions or events. Although many of our products or product candidates contain active ingredients that have already been approved, meaning that the side effects arising from the use of the active ingredient or class of drug in our products or product candidates is generally known, our products or product candidates may still cause undesirable or unknown side effects. These could be attributed to the active ingredient or class of drug or to our unique formulation and delivery method of such products or product candidates, or other potentially harmful characteristics. Such characteristics could cause us, our IRBs, clinical trial sites, the FDA, or other regulatory authorities to interrupt, delay or halt clinical trials and could result in a more restrictive label or the delay, denial, or withdrawal of regulatory approval, which may harm our business, financial condition, and prospects significantly.

Further, if any of our products cause serious or unexpected side effects during development or after receiving market approval, a number of potentially significant negative consequences could result. For example, regulatory authorities may impose a clinical hold, withdraw their approval of the product or impose restrictions on its distribution, the FDA may require implementation of risk evaluation and mitigation strategies, regulatory authorities may require the addition of labeling statements, such as warnings or contraindications, we may be required to change the way the product is administered or conduct additional clinical studies, we could be sued and held liable for harm caused to patients, and our reputation may suffer.

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If our products or product candidates do not produce the effects intended or if they cause undesirable side effects, our business may suffer.

If our products or product candidates do not have the effects intended or cause undesirable side effects, our business may suffer. In addition, our products may not have the effect intended if they are not used in accordance with applicable instructions. Furthermore, there can be no assurance that any of the products, even when used as directed, will have the effects intended or will not have harmful side effects in an unforeseen way or on an unforeseen patient population. If any of our products or products we develop or commercialize in the future are shown to be harmful or generate negative publicity from perceived lack of effect or harmful effects, our business, financial condition, results of operations and prospects could be harmed significantly. If the products do not offer a noticeable benefit over the currently marketed formulations, then adoption may also be affected. Further, if the products are equivalent but no better than what’s on the market, FDA may delay or deny approval.

If side effects are identified with our marketed products, or if manufacturing problems occur, changes in labeling of products may be required, which could have a material adverse effect on our sales of the affected products. We or regulatory authorities, including the FDA, could decide that changes to the product labeling are needed to ensure the safety and effectiveness of the products. Label changes may be necessary for a number of reasons, including the identification of actual or potential safety or efficacy concerns by regulatory agencies or the discovery of significant problems with a similar product that implicates an entire class of products. Any significant concerns raised about the safety or efficacy of the products could also result in the need to reformulate those products, to conduct additional clinical trials, to make changes to the manufacturing processes, or to seek re approval of the relevant manufacturing facilities. Significant concerns about the safety and effectiveness of a product could ultimately lead to the revocation of its marketing approval. Under the Food and Drug Administration Amendments Act of 2007, the FDA has broad authority to force drug manufacturers to take any number of actions if previously unknown safety or drug interaction problems arise, including but not limited to, mandating labeling changes to a product based on new safety information (safety labeling changes). New safety issues may require us to, among other things, provide additional warnings or restrictions on product package inserts, even including boxed warnings in the U.S. or similar warnings outside of the U.S., directly alert healthcare providers of new safety information, narrow our approved indications, alter or terminate current or planned trials for additional uses of products, or even remove a product from the market, any of which could have a significant adverse impact on potential sales of the products or require us to expend significant additional funds. The revision of product labeling or the regulatory actions described above could have a material adverse effect on our sales of the affected products and on our business and results of.

Interim “top-line” and preliminary data from our clinical trials that we announce or publish from time to time may change as more patient data become available and are subject to audit and verification procedures that could result in material changes in the final data.

From time to time, we may publish interim “top-line” or preliminary data from our clinical studies. Interim data from clinical trials that we may complete are subject to the risk that one or more of the clinical outcomes may materially change as patient enrollment continues and more patient data become available. Preliminary or “top-line” data also remain subject to audit and verification procedures that may result in the final data being materially different from the preliminary data we previously published. As a result, interim and preliminary data should be viewed with caution until the final data are available. Adverse differences between preliminary or interim data and final data could significantly harm our business prospects.

Our product candidates may cause serious adverse events or undesirable side effects, which may delay or prevent marketing approval, or, if approved, require them to be taken off the market, require them to include safety warnings, or otherwise limit their sales.

Serious adverse events or undesirable side effects caused by STAR-LLD or any other product candidates could cause us or regulatory authorities to interrupt, delay or halt clinical trials and could result in a more restrictive label or the delay or denial of regulatory approval by the FDA or other comparable foreign authorities. Results of any clinical trial we conduct could reveal a high and unacceptable severity and prevalence of side effects or unexpected characteristics. Any clinical trials for our drug product candidates that include STAR-LLD may fail to demonstrate acceptable levels of safety and efficacy which could prevent or significantly delay their regulatory approval or result in a more restrictive label by the FDA or other comparable foreign authorities.

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If unacceptable side effects arise in the development of our product candidates, we, the FDA or the IRBs at the institutions in which our studies are conducted, or the DSMB, if constituted for our clinical trials, could recommend a suspension or termination of our clinical trials, or the FDA or comparable foreign regulatory authorities could order us to cease further development of or deny approval of a product candidate for any or all targeted indications. In addition, drug-related side effects could affect patient recruitment or the ability of enrolled patients to complete a trial or result in potential product liability claims. In addition, these side effects may not be appropriately recognized or managed by the treating medical staff. We expect to have to train medical personnel using our product candidates to understand the side effect profiles for our clinical trials and upon any commercialization of any of our product candidates. Inadequate training in recognizing or managing the potential side effects of our product candidates could result in patient injury or death. Any of these occurrences may harm our business, financial condition, and prospects significantly.

Additionally, if one or more of our product candidates receives marketing approval, and we or others later identify undesirable side effects caused by such products, a number of potentially significant negative consequences could result, including:

• Regulatory authorities may withdraw approvals of such product;

• Regulatory authorities may require additional warnings on the label, such as a “black box” warning or contraindication;

• Additional restrictions may be imposed on the marketing of the particular product or the manufacturing processes for the product or any component thereof;

• We may be required to implement a REMS or create a medication guide outlining the risks of such side effects for distribution to patients;

• We could be sued and held liable for harm caused to patients;

• The product may become less competitive; and

• Our reputation may suffer.

Any of these events could prevent us from achieving or maintaining market acceptance of a product candidate, if approved, and could significantly harm our business, results of operations, and prospects.

The market opportunities for STAR-LLD may be smaller than we anticipate.

Our estimates of market potential have been derived from a variety of sources, including scientific literature, patient foundations, and market research, and may prove to be incorrect. Even if we obtain significant market share for any product candidate, following approval, if the potential target populations are smaller than we anticipate, we may never achieve profitability, for example, by obtaining marketing approval for additional indications.

Even if we obtain regulatory approval for any product candidate, we will still face extensive and ongoing regulatory requirements and obligations and any product candidates, if approved, may face future development and regulatory difficulties.

Even if our product candidates are approved, they will be subject to ongoing regulatory requirements for manufacturing, labeling, packaging, storage, advertising, distribution, promotion, sampling, record-keeping, conduct of post-marketing studies and submission of safety, efficacy and other post-market information, including both federal and state requirements in the United States and comparable requirements outside of the United States. Accordingly, we and others with whom we work must continue to expend time, money and effort in all areas of regulatory compliance, including manufacturing, production and quality control. If a regulatory agency discovers previously unknown problems with a product, such as adverse events of unanticipated severity or frequency, quality of product or disagrees with the promotion, marketing or labeling of a product, such regulatory agency may impose restrictions on that product or us, including requiring recall or withdrawal of the product from the market.

In addition, manufacturers of drug products and their facilities are subject to continual review and periodic inspections by the FDA and other regulatory authorities for compliance with cGMP, regulations and standards. If we or a regulatory agency discovers previously unknown problems with a product, such as adverse events of unanticipated severity or frequency, or problems with the facility where the product is manufactured, a regulatory agency may

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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. If we, our product candidates or the manufacturing facilities for our product candidates fail to comply with applicable regulatory requirements, or undesirable side effects caused by such products are identified, a regulatory agency may:

• issue safety alerts, “Dear Healthcare Provider” letters, press releases or other communications containing warnings about such product;

• mandate modification to promotional materials or require us to provide corrective information to healthcare practitioners;

• require that we conduct post-marketing studies;

• require us to enter into a consent decree, which can include imposition of various fines, reimbursements for inspection costs, required due dates for specific action and penalties for noncompliance;

• seek an injunction or impose civil or criminal penalties or monetary fines;

• suspend marketing of, withdraw regulatory approval of or recall such product;

• suspend any ongoing clinical studies;

• refuse to approve pending applications or supplements to applications filed by us;

• suspend or impose restrictions on operations, including costly new manufacturing requirements; or

• seize or detain products, refuse to import or export products or require us to initiate a product recall.

The occurrence of any event or penalty described above may inhibit our ability to commercialize our products and generate product revenue.

Potential product liability lawsuits against us could cause us to incur substantial liabilities and limit commercialization of any products that we may develop.

The use of STAR-LLD and/or any other product candidates we may develop in clinical trials and the sale of any products for which we obtain marketing approval exposes us to the risk of product liability claims. Product liability claims might be brought against us by patients, healthcare providers, pharmaceutical companies or others selling or otherwise coming into contact with our products. On occasion, large judgments have been awarded in class action lawsuits based on drugs that had unanticipated adverse effects. If we cannot successfully defend against product liability claims, we could incur substantial liability and costs. In addition, regardless of merit or eventual outcome, product liability claims may result in:

• Impairment of our business reputation and significant negative media attention;

• Withdrawal of participants from our clinical trials;

• Significant costs to defend the litigation;

• Distraction of management’s attention from our primary business;

• Substantial monetary awards to patients or other claimants;

• Inability to commercialize STAR-LLD, and/or any other product candidate;

• Product recalls, withdrawals, or labeling, marketing, or promotional restrictions;

• Decreased market demand for any product; and

• Loss of revenue.

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Risks Related to Commercialization

The successful commercialization of STAR-LLD, and/or any other product candidate we develop will depend in part on the extent to which governmental authorities and health insurers establish adequate coverage, reimbursement levels, and pricing policies. Failure to obtain or maintain coverage and adequate reimbursement for our product candidates, if approved, could limit our ability to market those products and decrease our ability to generate revenue.

There is significant uncertainty related to the insurance coverage and reimbursement of newly approved products. In the U.S., third-party payors, including private and governmental payors, such as the Medicare and Medicaid programs, play an important role in determining the extent to which new drugs and biologics will be covered. The Medicare and Medicaid programs increasingly are used as models in the U.S. for how private payors and other governmental payors develop their coverage and reimbursement policies for drugs and biologics. Some third-party payors may require pre-approval of coverage for new or innovative devices or drug therapies before they will reimburse healthcare providers who use such therapies. It is difficult to predict at this time what third-party payors will decide with respect to the coverage and reimbursement for our product candidates.

Therefore, the availability and adequacy of coverage and reimbursement by governmental healthcare programs such as Medicare and Medicaid, private health insurers and other third-party payors are essential for most patients to be able to afford newly approved prescription medications such as STAR-LLD if approved. Our ability to achieve acceptable levels of coverage and reimbursement for products by governmental authorities, private health insurers and other organizations will have an effect on our ability to successfully commercialize our drug and any other product candidates we develop. Assuming we obtain coverage for our product candidates by a third-party payor, the resulting reimbursement payment rates may not be adequate or may require co-payments that patients find unacceptably high. We cannot be sure that coverage and reimbursement in the U.S. or elsewhere will be available for our product candidates or any product that we may develop, and any reimbursement that may become available may be decreased or eliminated in the future.

We may also be subject to extensive governmental price controls and other market regulations outside of the U.S., and we believe the increasing emphasis on cost-containment initiatives in other countries have and will continue to put pressure on the pricing and usage of medical products. In many countries, the prices of medical products are subject to varying price control mechanisms as part of national health systems. Other countries allow companies to fix their own prices for medical products but monitor and control company profits.

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 U.S., the reimbursement for our product candidates may be reduced compared with the U.S. and may be insufficient to generate commercially reasonable revenue and profits. The downward pressure on healthcare costs in general, particularly prescription drugs and biologics and surgical procedures and other treatments, has become intense. As a result, increasingly high barriers are being erected to the entry of new products.

Moreover, increasing efforts by governmental and third-party payors in the U.S. to cap or reduce healthcare costs may cause such organizations to limit both coverage and the level of reimbursement for newly approved products and, as a result, they may not cover or provide adequate payment for our product candidates. We expect to experience pricing pressures in connection with the sale of our product candidates due to the trend toward managed health care, the increasing influence of health maintenance organizations and additional legislative changes.

For example, federal policymakers have intensified efforts to align U.S. prices for branded prescription drugs and biologics with the lowest prices paid in certain foreign markets (often referred to as “most-favored nation” or “MFN” pricing). Recent executive actions have directed federal agencies to communicate MFN-aligned price targets to manufacturers, explore rulemaking to impose MFN pricing where voluntary compliance is not achieved, facilitate direct-to-consumer purchasing channels, and consider additional measures, including importation pathways, enhanced antitrust scrutiny, and export controls on pharmaceuticals products or inputs. Any MFN initiative could reduce our realized net prices in the United States, which we anticipate will be our largest market for our future products. Because MFN constructs typically reference the lowest price available in a basket of developed countries (with or without adjustment for purchasing power), they can create a binding ceiling materially below prevailing U.S. net prices for certain products. The impact could be magnified if MFN benchmarks are set on net (confidential) prices rather than list prices, if MFN prices are extended beyond Medicare or Medicaid into other federal or commercial channels, or if government purchasers condition formulary access, coverage, or contracting on MFN compliance.

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MFN-aligned policies may also intersect with other federal drug pricing initiatives, including Medicare negotiation under Inflation Reduction Act, inflationary rebate provisions, and potential demonstration models under the Center for Medicare and Medicaid Innovation. The cumulative effect of overlapping policies could be materially greater than the effect of any single program, and the timing, scope, and mechanics of these interactions remain uncertain. The ultimate scope, timing, and enforceability of MFN or MFN-like initiatives are uncertain and may be subject to legal challenge, congressional action, administrative discretion, and changes in Administration policy. We cannot predict whether, when, or how MFN pricing or related measures will be implemented, expanded, or enforced, or the extent to which third parties (including payers, PBMs, wholesalers, pharmacies, group purchasing organizations, hospital systems, and international health authorities) will adopt MFN-aligned expectations in their dealings with us if we are successful in commercializing any product. Any of the foregoing, individually or in the aggregate, could have a material adverse effect on our business, financial condition, cash flows, results of operations, and ability to execute our strategy.

It may be difficult for us to profitably sell our products, if and when approved, if coverage and reimbursement for our product candidates are limited by third-party payor policies.

Third-party payors increasingly are challenging prices charged for pharmaceutical products and services, and many third-party payors may refuse to provide coverage and reimbursement for particular drugs or biologics when an equivalent generic drug, biosimilar, or a less expensive therapy is available. It is possible that a third-party payor may consider our product candidates as substitutable and offer to reimburse patients only for the less expensive product.

Even if we show improved efficacy or improved convenience of administration with our product candidates, pricing of existing drugs may limit the amount we will be able to charge for our product candidates. These payors may deny or revoke the reimbursement status of a given product or establish prices for new or existing marketed products at levels that are too low to enable us to realize an appropriate return on our investment in our product candidates. If reimbursement is not available or is available only at limited levels, we may not be able to successfully commercialize our product candidates and may not be able to obtain a satisfactory financial return on our product candidates.

Moreover, no uniform policy for coverage and reimbursement for products exists among third-party payors in the U.S. Therefore, coverage and reimbursement for 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 product candidates to each payor separately, with no assurance that coverage and adequate reimbursement will be applied consistently or obtained in the first instance. Furthermore, rules and regulations regarding reimbursement change frequently, in some cases at short notice, and we believe that changes in these rules and regulations are likely.

Even if STAR-LLD, and/or any product candidate we develop receives marketing approval, it may fail to achieve market acceptance by physicians, patients, third-party payors or others in the medical community necessary for commercial success.

If STAR-LLD, and/or any product candidate we develop receives marketing approval, it may nonetheless fail to gain sufficient market acceptance by physicians, patients, third-party payors, and others in the medical community. If it does not achieve an adequate level of acceptance, we may not generate significant product revenues or become profitable. The degree of market acceptance of our product candidates, if approved, will depend on a number of factors, including but not limited to:

• The efficacy and potential advantages compared to alternative treatments;

• Effectiveness of sales and marketing efforts;

• The cost of treatment in relation to alternative treatments, including any similar generic treatments;

• Our ability to offer our products for sale at competitive prices;

• The convenience and ease of administration compared to alternative treatments;

• The willingness of the target patient population to try new therapies and of physicians to prescribe these therapies;

• The strength of marketing and distribution support;

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• The availability of third-party coverage and adequate reimbursement;

• The prevalence and severity of any side effects; and

• Any restrictions on the use of our product together with other medications.

Because we expect sales of our product candidates, if approved, to generate substantially all of our revenues for the foreseeable future, the failure of our product candidates to find market acceptance would harm our business and could require us to seek additional financing.

If we are unable to establish sales, marketing, and distribution capabilities either on our own or in collaboration with third parties, we may not be successful in commercializing STAR-LLD.

We do not have any infrastructure for the sales, marketing, or distribution of STAR-LLD, and the cost of establishing and maintaining such an organization may exceed the cost-effectiveness of doing so. In order to market and successfully commercialize our drug or any product candidate we develop, we must build our sales, distribution, marketing, managerial and other non-technical capabilities or make arrangements with third parties to perform these services. We expect to build a focused sales, distribution, and marketing infrastructure to market STAR-LLD/in the U.S. There are significant expenses and risks involved with establishing our own sales, marketing, and distribution capabilities, including our ability to hire, retain, and appropriately incentivize qualified individuals, generate sufficient sales leads, provide adequate training to sales and marketing personnel, and effectively manage a geographically dispersed sales and marketing team. Any failure or delay in the development of our internal sales, marketing and distribution capabilities could delay any product launch, which would adversely impact the commercialization of that product. For example, if the commercial launch of STAR-LLD for which we recruit a sales force and establish marketing capabilities is delayed or does not occur for any reason, we would have prematurely or unnecessarily incurred these commercialization expenses. This may be costly, and our investment would be lost if we cannot retain or reposition our sales and marketing personnel.

Factors that may inhibit our efforts to commercialize our product candidates on our own include:

• Our inability to recruit, train and retain adequate numbers of effective sales and marketing personnel;

• The inability of sales personnel to obtain access to physicians or attain adequate numbers of physicians to prescribe our products; and

• Unforeseen costs and expenses associated with creating an independent sales and marketing organization.

If we are unable to build our own sales force or negotiate a collaborative relationship for the commercialization of STAR-LLD we may be forced to delay the potential commercialization of the drug or reduce the scope of our sales or marketing activities. If we need to increase our expenditures to fund commercialization activities for STAR-LLD we will need to obtain additional capital, which may not be available to us on acceptable terms, or at all. We may also have to enter into collaborative arrangements for STAR-LLD at an earlier stage than otherwise would be ideal and we may be required to relinquish rights to it or otherwise agree to terms unfavorable to us. Any of these occurrences may have an adverse effect on our business, operating results, and prospects.

If we are unable to establish adequate sales, marketing, and distribution capabilities, either on our own or in collaboration with third parties, we will not be successful in commercializing our product candidates and may never become profitable. We will be competing with many companies that currently have extensive and well-funded marketing and sales operations. Without an internal team or the support of a third party to perform marketing and sales functions, we may be unable to compete successfully against these more established companies.

Risks Related to Healthcare Laws and Other Legal Compliance Matters

Enacted and future healthcare legislation may increase the difficulty and cost for us to obtain marketing approval of and commercialize our product candidates, if approved, and may affect the prices we may set.

In both the United States and certain foreign countries, there have been a number of legislative and regulatory changes or proposed changes to the healthcare system, many of which have focused on prescription drug pricing and lowering overall healthcare costs, that could impact our ability to sell our products profitably and support future innovation. We expect prescription drug pricing and other healthcare costs to continue to be subject to intense political and social pressures on a global scale.

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In the United States, the President, federal and state legislatures, health agencies and third-party payors continue to focus on containing the cost of healthcare and addressing public concern over access and affordability of prescription drugs. The Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act of 2010 (collectively, the ACA), made significant changes to the U.S. healthcare system, which included expanding healthcare coverage through Medicaid and implementation of the individual health insurance mandate; changing coverage and reimbursement of drug products under Medicare, Medicaid and 340B government programs; imposing an annual fee on manufacturers of branded drugs; and expanding government enforcement authority. The ACA has been the subject of legislative and litigation challenges. We cannot predict what effect, if any, further changes to the ACA would have on our business, if any.

In the current U.S. administration, we are uncertain of the impact or outcome of potential Executive Orders, rescission of rules and policy statements, or new legislation including the imposition of tariffs, especially any relative impact on the healthcare regulatory and policy landscape, or the impact they may have on our business. Any significant spending reductions affecting Medicare, Medicaid or other publicly funded or subsidized health programs, or any significant taxes or fees imposed as part of any broader deficit reduction effort or legislative replacement to the Budget Control Act, or otherwise, could have an adverse impact on our anticipated product revenues.

There have been several recent U.S. Congressional inquiries and proposed and enacted legislation designed to bring more transparency to drug pricing, reduce the cost of prescription drugs, and reform government health care program reimbursement methodologies for prescription drugs. On September 20, 2024, CMS issued a final rule titled “Medicaid Program; Misclassification of Drugs, Program Integrity Updates Under the Medicaid Drug Rebate Program” which may impact our reimbursement and rebate strategy. We expect that health care reform measures that may be adopted in the future may result in increased manufacturer financial liability and additional downward pressure on the price that we may receive for any of our product candidates, if approved. Any reduction in reimbursement from Medicare or other government health care programs may result in a similar reduction in payments from private payors.

The Inflation Reduction Act of 2022 (IRA) included, among other provisions, several measures intended to lower the cost of prescription drugs and related healthcare reforms. Specifically, the IRA authorizes and directs the Centers for Medicare and Medicaid Services (CMS) to set drug prices for certain Medicare Part B and Part D qualified drugs with the greatest expense to the program, with the first year of maximum price applicability to begin in 2026 and an expanding list of selected drugs each year after. The Act further authorizes CMS to levy a financial penalty on pharmaceutical manufacturers that increase the price of certain Medicare Part B and Part D drugs faster than the rate of inflation. Finally, the IRA creates significant changes to the Medicare Part D benefit design by capping Part D beneficiaries’ annual out-of-pocket spending at $2,000 beginning in 2025 and creating new financial liabilities for drug manufacturers and health plans providing Part D benefits. We cannot be sure whether additional or related legislation or rulemaking will be issued or enacted, or what impact, if any, such changes will have on our reimbursement strategy and the profitability of any of our drug candidates, if approved for commercial use, in the future.

Furthermore, legislative and regulatory proposals have been made to expand post-approval requirements, make changes to the Orphan Drug Act and related guidance, reform the 340B Drug Pricing Program, and restrict sales and promotional activities for drugs. With respect to the 340B Drug Pricing Program, recent legislative proposals, as well as judicial challenges to DHHS’s policies, present both opportunities and challenges for drug manufacturers participating in the program. Further, we cannot be sure whether additional legislative changes will be enacted, or whether the FDA regulations, guidance or interpretations will be changed, or what the impact of such changes on the marketing approvals of our product candidates, if any, may be. In addition, increased scrutiny by Congress of the FDA’s approval process may significantly delay or prevent marketing approval, as well as subject us to more stringent product labeling and post-marketing testing and other requirements.

In many international markets, including the European Union, the government regulates prescription drug prices, patient access, and/or reimbursement levels to control the biopharmaceutical budget of their government-sponsored healthcare system. The European Union and some individual countries have announced or implemented measures and may in the future implement new or additional measures, to reduce biopharmaceutical costs to contain healthcare expenditures. These measures vary by country and may include, among other things, non-coverage decisions, patient access restrictions, international price referencing, mandatory discounts or rebates, and cross-border sales of prescription drugs. These measures may impact our reimbursement strategy and could adversely affect our ability to generate revenues or commercialize STAR-LLD or other product candidates in certain international markets.

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At the state level, individual states are experiencing significant economic pressure within their respective Medicaid programs and responding to public concern over the cost of healthcare. States, including California, Florida, Nevada and Maine, among others, have responded to these pressures with a range of legislative enactments and policy proposals designed to control prescription drug prices by, for example, allowing importation of pharmaceutical products from jurisdictions outside the U.S., imposing Prescription Drug Affordability Boards, some with the ability to impose price controls on state drug purchases and imposing transparency measures around prescription drug prices and marketing costs. These measures, which vary by state, could adversely impact our coverage and reimbursement of our product candidates, reduce the ultimate demand for our products, if approved, and put pressure on our product net pricing. Legally mandated price controls on payment amounts by third-party payors or other restrictions could harm our business, results of operations, financial condition and prospects. In addition, regional healthcare authorities and individual hospitals are increasingly using bidding procedures to determine what pharmaceutical products and which suppliers will be included in their prescription drug and other healthcare programs. This could reduce the ultimate demand for STAR-LLD and any future product candidates, if approved, or put pressure on our product pricing, which could negatively affect our business, results of operations, financial condition and prospects.

We expect that these new laws and other healthcare reform measures that may be adopted in the future may result in additional reductions in Medicare and other healthcare funding, more rigorous coverage criteria, new payment methodologies and additional downward pressure on the price that we receive for any approved product. Any reduction in reimbursement from Medicare or other government programs may result in a similar reduction in payments from private payors. There likely will continue to be pressure on prescription drug prices globally and legislative and regulatory proposals, including at the federal and state levels in the U.S., directed at broadening the availability of health care and containing or lowering the cost of health care products and services. The implementation of these cost containment measures or other healthcare reforms may prevent us from being able to generate revenue, attain profitability or commercialize STAR-LLD and any future product candidates, if approved, impact our ability to set a price that we believe is fair for our products, the level of taxes we are required to pay, and the availability of capital.

Our business operations and current and future relationships with investigators, healthcare professionals, consultants, third-party payors, patient organizations, and customers will be subject to applicable healthcare regulatory laws, which could expose us to penalties.

Our business operations and current and future arrangements with investigators, healthcare professionals, consultants, third-party payors, patient organizations, and customers, may expose us to broadly applicable fraud and abuse and other healthcare laws and regulations. These laws may constrain the business or financial arrangements and relationships through which we conduct our operations, including how we research, market, sell and distribute our product candidates, if approved. Such laws include:

• The U.S. federal Anti-Kickback Statute, which prohibits, among other things, persons or entities from knowingly and willfully soliciting, offering, receiving, or providing any remuneration (including any kickback, bribe, or certain rebate), directly or indirectly, overtly or covertly, in cash or in kind, to induce or reward, or in return for, either the referral of an individual for, or the purchase, lease, order, or recommendation of, any good, facility, item, or service, for which payment may be made, in whole or in part, under U.S. federal and state healthcare programs such as Medicare and Medicaid. A person or entity does not need to have actual knowledge of the statute or specific intent to violate it in order to have committed a violation. The U.S. federal Anti-Kickback Statute has been interpreted to apply to arrangements between pharmaceutical manufacturers on the one hand and prescribers, purchasers, and formulary managers on the other hand. Although there are several statutory exceptions and regulatory safe harbors protecting certain common activities from prosecution, they are drawn narrowly, and practices that involve remuneration intended to induce prescribing, purchasing or recommending or arranging for the prescription or purchase of any drug product may be subject to scrutiny if they do not qualify for an exception or safe harbor. This law applies to our marketing practices, educational programs, pricing policies and relationships with healthcare providers. We continue to evaluate what effect, if any, these rules will have on our business;

• The U.S. federal false claims and civil monetary penalties laws, including the civil FCA which, among other things, impose criminal and civil penalties, including through civil whistleblower or qui tam actions, against individuals or entities for knowingly presenting, or causing to be presented, to the U.S. federal government, claims for payment or approval that are false or fraudulent, knowingly making, using or causing to be made or used, a false record or statement material to a false or fraudulent claim, or from knowingly

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making a false statement to avoid, decrease or conceal an obligation to pay money to the U.S. federal government. In addition, the government may assert that a claim including items and services resulting from a violation of the U.S. federal Anti-Kickback Statute or the Federal Food, Drug, and Cosmetic Act (FDC Act) constitutes a false or fraudulent claim for purposes of the FCA. A claim includes “any request or demand” for money or property presented to the federal government. In addition, manufacturers can be held liable under the FCA even when they do not submit claims directly to government payors if they are deemed to “cause” the submission of false or fraudulent claims;

• HIPAA, which imposes criminal and civil liability for, among other things, knowingly and willfully executing, or attempting to execute, a scheme to defraud any healthcare benefit program or 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, any healthcare benefit program, regardless of the payor (e.g., public or private) and knowingly and willfully falsifying, concealing or covering up a material fact or making any materially false statement, in connection with the delivery of, or payment for, healthcare benefits, items or services. Similar to the U.S. federal Anti-Kickback Statute, a person or entity does not need to have actual knowledge of the statute or specific intent to violate it in order to have committed a violation;

• HIPAA, as amended by the HITECH, and their respective implementing regulations, which impose, among other things, specified requirements relating to the privacy, security and transmission of individually identifiable health information without appropriate authorization by covered entities subject to the rule, such as health plans, healthcare clearinghouses and healthcare providers as well as their business associates that perform certain services involving the use or disclosure of individually identifiable health information. HITECH also created new tiers of civil monetary penalties, amended HIPAA to make civil and criminal penalties directly applicable to business associates 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;

• The FDC Act, and its implementing regulations, which prohibits, among other things, the adulteration or misbranding of drugs, biologics and medical devices;

• A wide range of federal and state consumer protection and unfair competition laws, which broadly regulate marketplace activities and activities that potentially harm consumers, including those related to privacy;

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

• Federal laws, including the Medicaid Drug Rebate Program, that requires pharmaceutical manufacturers to report certain calculated product prices to the government or provide certain discounts or rebates to government authorities or private entities, often as a condition of reimbursement under government healthcare programs and the 340B Drug Discount Pricing Program which requires pharmaceutical manufacturers offering their products through the Medicaid program to offer discounts on those drugs to certain 340B covered entities;

• The Drug Supply Chain Security Act (DSCSA), which imposes obligations on entities in the commercial product supply chain, including manufacturers, to identify and track prescription drugs as they are distributed in the U.S

• Analogous U.S. state laws and regulations, including: state anti-kickback and false claims laws, which may apply to our business practices, including but not limited to, research, distribution, sales, and marketing arrangements and claims involving healthcare items or services reimbursed by any third-party payor, including private insurers; state laws that require pharmaceutical companies to comply with the pharmaceutical industry’s voluntary compliance guidelines and the relevant compliance guidance

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promulgated by the U.S. federal government, or otherwise restrict payments that may be made to healthcare providers and other potential referral sources; state laws and regulations that require drug manufacturers to file reports relating to pricing and marketing information, which requires tracking gifts and other remuneration and items of value provided to healthcare professionals and entities; 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 often are not preempted by HIPAA, thus complicating compliance efforts.

Because of the breadth of these laws and the narrowness of the statutory exceptions and regulatory safe harbors available under such laws, it is possible that some of our business activities, including our consulting agreements and other relationships with physicians and other healthcare providers, some of whom receive stock or stock options as compensation for their services, could be subject to challenge under one or more of such laws. Ensuring that our current and future internal operations and business arrangements with third parties comply with applicable healthcare laws and regulations will involve substantial costs. It is possible that governmental authorities will conclude that our business practices do not comply with current or future statutes, regulations, agency guidance or case law involving applicable fraud and abuse or other healthcare laws and regulations.

If our operations are found to be in violation of any of the laws described above or any other governmental laws and regulations that may apply to us, we may be subject to the imposition of civil, criminal and administrative penalties, damages, disgorgement, monetary fines, possible exclusion from participation in Medicare, Medicaid, and other federal healthcare programs, individual imprisonment, contractual damages, reputational harm, diminished profits and future earnings, additional reporting requirements or oversight if we become subject to a corporate integrity agreement or similar agreement to resolve allegations of non-compliance with these laws, and curtailment or restructuring of our operations, any of which could adversely affect our ability to operate our business and our results of operations. If any of the physicians or other providers or entities with whom we expect to do business are found to not be in compliance with applicable laws, they may be subject to criminal, civil or administrative sanctions, including exclusions from government funded healthcare programs and imprisonment, which could affect our ability to operate our business. Further, defending against any such actions can be costly, time-consuming and may require significant personnel resources. Therefore, even if we are successful in defending against any such actions that may be brought against us, our business may be impaired.

Changes in patent laws or patent jurisprudence could diminish the value of patents in general, thereby impairing our ability to protect our products and product candidates.

As is the case with other biotechnology and pharmaceutical companies, our success is heavily dependent on intellectual property, particularly patents. Obtaining and enforcing patents in the biotechnological and pharmaceutical industries involve both technological complexity and legal complexity. Therefore, obtaining and enforcing patents is costly, time-consuming, and inherently uncertain. In addition, the America Invents Act (“AIA”), which was passed in September 2011, resulted in significant changes to the U.S. patent system.

An important change introduced by the AIA is that, as of March 16, 2013, the U.S. transitioned to a “first-to-file” system for deciding which party should be granted a patent when two or more patent applications are filed by different parties claiming the same invention. A third party that files a patent application in the PTO after that date but before us could therefore be awarded a patent covering an invention of ours even if we made the invention before it was made by the third party. This will require us to be cognizant going forward of the time from invention to filing of a patent application, but circumstances could prevent us from promptly filing patent applications on our inventions.

Among some of the other changes introduced by the AIA are changes that limit where a patentee may file a patent infringement suit and providing opportunities for third parties to challenge any issued patent before the PTO. This applies to all of our U.S. patents, even those effectively filed before March 16, 2013. Because of a lower evidentiary standard in PTO proceedings compared to the evidentiary standard in U.S. federal courts necessary to invalidate a patent claim, a third party could potentially provide evidence in a PTO proceeding sufficient for the PTO to hold a claim invalid even though the same evidence would be insufficient to invalidate the claim if first presented in a district court action.

Accordingly, a third party may attempt to use the PTO procedures to invalidate our patent claims that would not have been invalidated if first challenged by the third party as a defendant in a district court action. It is not clear what, if any, impact the AIA will have on the operation of our business. However, the AIA and its implementation could increase the uncertainties and costs surrounding the prosecution of our owned and in-licensed patent applications and the enforcement or defense of our owned and in-licensed patents.

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Additionally, the U.S. Supreme Court has ruled on several patent cases in recent years either narrowing the scope of patent protection available in certain circumstances or weakening the rights of patent owners in certain situations. In addition to increasing uncertainty with regard to our ability to obtain patents in the future, this combination of events has created uncertainty with respect to the value of patents, once obtained. Depending on decisions by Congress, the federal courts and the PTO, the laws and regulations governing patents could change in unpredictable ways that could weaken our ability to obtain new patents or to enforce our existing patents and patents that we might obtain in the future. Similarly, the complexity and uncertainty of European patent laws has also increased in recent years. In addition, the European patent system is relatively stringent in the type of amendments that are allowed during prosecution. Complying with these laws and regulations could limit our ability to obtain new patents in the future that may be important for our business.

If we do not obtain patent term extension in the U.S. under the Hatch-Waxman Act and in foreign countries under similar legislation, thereby potentially extending the term of marketing exclusivity for our products, our business may be materially harmed.

Patents have a limited lifespan. In the U.S., if all maintenance fees are timely paid, the natural expiration of a patent is generally 20 years from its earliest U.S. non-provisional filing date. Various extensions may be available, but the life of a patent, and the protection it affords, is limited. Even if patents covering our products are obtained, once the patent life has expired for a product, we may be open to competition from competitive medications, including generic medications. Given the amount of time required for the development, testing and regulatory review of new products, patents protecting such candidates might expire before or shortly after such candidates are commercialized. As a result, our owned and licensed patent portfolio may not provide us with sufficient rights to exclude others from using or commercializing technologies or products similar or identical to ours.

Depending upon the timing, duration, and conditions of FDA marketing approval of our product candidates, we may be able to extend the term of a patent covering each product candidate under the Drug Price Competition and Patent Term Restoration Act of 1984, referred to as the Hatch-Waxman Act, and similar legislation in the EU. The Hatch-Waxman Act permits a patent term extension of up to five years for a patent covering an approved product as compensation for effective patent term lost during product development and the FDA regulatory review process. Patent term extension cannot extend the remaining term of a patent beyond a total of 14 years from the date of product approval, and only one patent that is applicable to and covers an approved drug may be extended. Similar provisions are available in Europe, such as supplementary protection certificates, and in certain other non-U.S. jurisdictions to extend the term of a patent that covers an approved drug. However, we may not receive an extension if we fail to apply within applicable deadlines, fail to apply prior to expiration of relevant patents or otherwise fail to satisfy applicable requirements. Moreover, the length of a patent term extension could be less than we request. If we are unable to obtain patent term extension or the term of any such extension is less than we request, the period during which we can enforce our patent rights for that product will be shortened and our competitors may obtain approval to market competing products sooner. As a result, our revenue from applicable products could be reduced, possibly materially.

Further, under certain circumstances, the term of a patent covering our products may be extended for time spent during the pendency of the corresponding patent application in the PTO (referred to as Patent Term Adjustment (“PTA”)). The laws and regulations underlying how the PTO calculates the PTA is subject to change and any such PTA granted by the PTO could be challenged by a third party. If we do not prevail under such a challenge, the PTA may be reduced or eliminated, resulting in a shorter patent term, which may negatively impact our ability to exclude competitors.

Because PTA added to the term of patents covering pharmaceutical products has particular value, our business may be adversely affected if the PTA is successfully challenged by a third party and our ability to exclude competitors is reduced or eliminated.

We and our service providers may be subject to a variety of privacy and data security laws and contractual obligations, which could increase compliance costs, and our actual or perceived failure to comply with such laws and obligations could subject us to potentially significant liability, fines or penalties and otherwise harm our business.

We and our service providers maintain and will maintain a large quantity of sensitive information, including confidential business and patient health information, in connection with our preclinical studies and clinical trials, and are subject to laws and regulations governing the privacy and security of such information. The global data protection

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landscape is rapidly evolving, and we and our service providers may be affected by or subject to new, amended or existing laws and regulations in the future, including as our operations continue to expand or if we decide to operate in foreign jurisdictions. These laws and regulations may be subject to differing interpretations, which adds to the complexity of processing personal data. Guidance on implementation and compliance practices is often updated or otherwise revised. This may create uncertainty in our business, affect our ability to operate in certain jurisdictions or to collect, store, transfer, use, share and otherwise process personal information, necessitate the acceptance of more onerous obligations in our contracts, result in liability or impose additional costs on us. These laws are rapidly changing, such that tracking, analyzing, and complying with these laws requires significant time and expenses and can materially impact our business, as it may require investing in additional security system technical upgrades, updating contracts, consent forms, internal policies and procedures, external privacy notices, and other protocols. Any failure or perceived failure by us to comply with federal, state or foreign laws or regulation, our internal policies and procedures or our contracts governing our processing of personal information could result in negative publicity, government investigations and enforcement actions, claims by third parties and damage to our reputation, any of which could have a material adverse effect on our business, financial condition, results of operations and prospects.

As our operations and business grow, we may become subject to or affected by new or additional data protection laws and regulations and face increased scrutiny or attention from regulatory authorities. In the United States, numerous federal and state laws and regulations, including health information privacy laws, data breach notification laws and consumer protection laws (e.g., Section 5 of the Federal Trade Commission Act), that govern the collection, use, storage, transfer, disclosure, protection and other processing of health-related and other personal information could apply to our operations or the operations of our collaborators and third-party providers. In addition, we may obtain health information from third parties (including research institutions from which we obtain clinical trial data) that are subject to privacy and security requirements under HIPAA. While we are not currently a covered entity under HIPAA, our future operations could subject us to HIPAA as a business associate, or even a covered entity. Depending on the facts and circumstances, we could be subject to significant penalties if we violate HIPAA.

In addition, certain state laws govern the privacy and security of health-related and other personal information in certain circumstances, some of which may be more stringent, broader in scope or offer greater individual rights with respect to protected health information than HIPAA, many of which may differ from each other, thus, complicating compliance efforts. These laws are evolving rapidly and may differ from each other in significant ways and may not have the same effect, thus complicating compliance efforts. Such laws and regulations will be subject to interpretation by various courts and other governmental authorities, thus creating potentially complex compliance issues for us and our future customers and strategic partners. Failure to comply with these laws, where applicable, can result in the imposition of significant civil and/or criminal penalties and private litigation. By way of example, the California Consumer Privacy Act (CCPA), which went into effect on January 1, 2020, gives California residents individual privacy rights to access and delete their personal information, opt out of certain personal information sharing, and receive detailed information about how their personal information is used. The CCPA provides for civil penalties for violations, as well as a private right of action for data breaches that are expected to increase data breach litigation. The CCPA may increase our compliance costs and potential liability and many similar laws have been proposed at the federal level and in other states. Further, the California Privacy Rights Act (CPRA) imposes additional data protection obligations on covered businesses, including additional consumer rights processes, limitations on data uses, new audit requirements for higher risk data, and opt outs for certain uses of sensitive data. It also created a new California data protection agency authorized to issue substantive regulations and could result in increased privacy and information security enforcement. The majority of the provisions of the CPRA went into effect on January 1, 2023. Other states are exploring their own laws, which may or may not be similar to the CCPA or the CPRA. Other states have followed California, including, but not limited to, Colorado, Connecticut, Utah, Virginia, and Washington. In the event that we are subject to or affected by HIPAA, the CCPA, the CPRA or other domestic privacy and data protection laws, any liability from failure to comply with the requirements of these laws could adversely affect our financial condition.

There also are a wide variety of privacy laws in other countries that may impact our operations, now or in the future. For example, in Europe, the General Data Protection Regulation (GDPR) imposes stringent requirements regarding the collection, use, disclosure, storage, transfer or other processing of personal data of individuals within the European Economic Area (EEA), including providing information to individuals regarding data processing activities, implementing safeguards to protect the security and confidentiality of personal data, providing notification of data breaches and taking certain measures when engaging third-party processors. Companies that must comply with the GDPR face increased compliance obligations and risk, including more robust regulatory enforcement of data protection requirements and potential fines for noncompliance of up to €20 million or 4% of the annual global revenue of the

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noncompliant company, whichever is greater. The GDPR also confers a private right of action in some circumstances on data subjects and consumer associations to lodge complaints with supervisory authorities, seek judicial remedies and obtain compensation for damages resulting from violations of the GDPR. Among other things, the GDPR requires the establishment of a lawful basis for the processing of data, imposes requirements relating to the consent of the individuals to whom the personal data relates, including detailed notices for clinical trial subjects and investigators, as well as requirements regarding the security of personal data and notification of data processing obligations to the competent national data processing authorities. In addition, the GDPR increases the scrutiny of transfers of personal data from the EEA to the United States and other jurisdictions that the European Commission does not recognize as having “adequate” data protection laws. Recent legal developments in Europe have created complexity and uncertainty regarding transfers of personal data from the EEA to the United States. For example, on July 16, 2020, the Court of Justice of the European Union (CJEU) invalidated the EU-US Privacy Shield Framework (Privacy Shield) under which personal data could be transferred from the EEA to United States entities that 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 the standard contractual clauses 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. The European Commission issued revised standard contractual clauses on June 4, 2021 to account for the decision of the CJEU and recommendations made by the European Data Protection Board. The revised standard contractual clauses must be used for relevant new data transfers beginning on September 27, 2021 and existing standard contractual clauses arrangements must be migrated to the revised clauses by December 27, 2022. The new standard contractual clauses apply only to the transfer of personal data outside of the EEA and not the United Kingdom; the United Kingdom’s Information Commissioner’s Office launched a public consultation on its draft revised data transfers mechanisms in August 2021 and the United Kingdom standard contractual clauses came into force in March 2022, with a two-year grace period. There is some uncertainty around whether the revised clauses can be used for all types of data transfers, particularly whether they can be relied on for data transfers to non-EEA entities subject to the GDPR. 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.

Further, following the withdrawal of the United Kingdom from the European Union and the EEA and the end of the transition period, we have to comply with the GDPR and separately the GDPR as implemented in the United Kingdom, which, together with the amended UK Data Protection Act 2018, retains the GDPR in UK national law. The UK GDPR mirrors the fines under the GDPR and has the ability to fine up to the greater of €20 million/£17 million or 4% of global turnover. The relationship between the United Kingdom and the European Union and the EEA in relation to certain aspects of data protection law remains unclear, and it is unclear how United Kingdom data protection laws and regulations will develop in the medium to longer term. The European Commission has adopted an adequacy decision in favor of the United Kingdom, enabling data transfers from EU member states to the United Kingdom without additional safeguards. However, the UK adequacy decision will automatically expire in June 2025 unless the European Commission re-assesses and renews or extends that decision, which could have implications for our transfer of personal data.

In many jurisdictions, enforcement actions and consequences for noncompliance are rising. If we experience a reportable data breach that is subject to any federal, state, or international data privacy and security laws or if our operations are found to otherwise be in violation of any data privacy and security laws, rules or regulations that apply to us, we may be subject to penalties, including civil and criminal penalties, damages, fines, litigation, and the curtailment or restructuring of our operations, which could adversely affect our ability to operate our business and our financial results. In the United States, these include enforcement actions in response to rules and regulations promulgated under the authority of federal agencies and state attorneys general and legislatures and consumer protection agencies. Compliance in the event of a widespread data breach is costly. Although compliance programs can mitigate the risk of investigation and prosecution for violations of these laws, rules or regulations, we cannot be certain that our program will address all areas of potential exposure and the risks in this area cannot be entirely eliminated, particularly because the requirements and government interpretations of the requirements in this space are constantly evolving. Any action

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against us for violation of these laws, rules or regulations, even if we successfully defend against it, could cause us to incur significant legal expenses and divert our management’s attention from the operation of our business, as well as damage our business or reputation. Moreover, achieving and sustaining compliance with applicable federal and state privacy, security, fraud and reporting laws may prove costly.

Additionally, privacy advocates and industry groups have regularly proposed, and may propose in the future, self-regulatory standards that may legally or contractually apply to us. If we fail to follow these security standards, even if no personal information is compromised, we may incur significant fines or experience a significant increase in costs.

Compliance with U.S. and international data protection laws and regulations could require us to take on more onerous obligations in our contracts, restrict our ability to collect, store, use, transfer, disclose and otherwise process data, update our data privacy and security policies and procedures, or in some cases, impact our ability to operate in certain jurisdictions. Failure by us or our collaborators and our service providers to comply with U.S. and international data protection laws and regulations could result in government enforcement actions (which could include civil or criminal penalties), private litigation and/or adverse publicity and could negatively affect our operating results and business. Moreover, clinical trial subjects about whom we or our potential collaborators obtain information, as well as the providers who share this information with us, may contractually limit our ability to use and disclose such information. Claims that we have violated individuals’ privacy rights, failed to comply with data protection laws, or breached our contractual obligations, even if we are not found liable, could be expensive and time consuming to defend, could result in adverse publicity and adversely affect our business, financial condition, results of operations and prospects. Should any of these events occur, they could have a material adverse effect on our business, financial condition, results of operations and prospects.

Risks Related to the Shares of Common Stock and this Offering

There is no active market for the Company’s securities.

Currently, no active market exists for the shares of common stock and there is no assurance that an active trading market will ever develop or, if developed, that it will be sustained. A purchaser of the shares of common stock may, therefore, be unable to resell the purchased securities. Consequently, holders of the shares of common stock may not be able to liquidate their investment in the event of an emergency or for any other reason, and the purchased securities may not be readily accepted as collateral for a loan. Therefore, proposed investors are advised that the purchase of the shares of common stock should be considered only as a long-term and speculative high-risk investment. Due to the absence of a public market for the purchased securities: (i) investors may not be able to liquidate their investment in the event of an unexpected need for cash; (ii) transferability of the purchased securities is extremely limited; and (iii) in the event of a disposition of the purchased securities, the investor could sustain a loss of all or any part of his investment.

Our management team will have immediate and broad discretion over the use of the net proceeds from this offering and may not use them effectively.

We currently intend to use the net proceeds from this offering to support our product development activities for our lead program, STAR-LLD, including conducting clinical development and managing regulatory affairs for our product candidates; and for working capital and other general corporate purposes, including payment of certain outstanding trade payables and other amounts due and owing to related parties. See “Use of Proceeds” and “Certain Relationships and Related Transactions, and Director Independence — Deferred Consulting and Service Fees.” Our management will have broad discretion in the application of the net proceeds. Our stockholders may not agree with the manner in which our management chooses to allocate the net proceeds from this offering. The failure by our management to apply these funds effectively could have a material adverse effect on our business, financial condition, and results of operation.

We do not have any current plans to pay dividends on our shares of common stock.

We do not anticipate paying any cash dividends in the foreseeable future. If we incur indebtedness in the future to fund our future growth, our ability to pay dividends may be further restricted by the terms of such indebtedness.

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Because a small number of existing stockholders own a large percentage of our voting stock, you will have minimal influence over shareholder decisions.

Existing management has significant stock ownership in the Company representing approximately 24.7% of the issued and outstanding shares of common stock prior to this offering and approximately 20.5% of the issued and outstanding shares of common stock following the consummation of this offering (or approximately 20.0% if the underwriter’s over-allotment option to purchase additional shares of our shares of common stock from us is exercised in full). As a result of such ownership concentration, these individuals will have significant influence over the management and affairs of the Company and its business. It will also exert considerable, ongoing influence over matters subject to stockholder approval, including the election of directors and significant corporate transactions, such as a merger, sale of assets or other business combination or sale of the Company. This concentration of ownership may have the effect of delaying, deferring, or preventing a change in control, impeding a merger, consolidation, takeover or other business combination involving us, or discouraging a potential acquirer from making a tender offer or otherwise attempting to obtain control of the Company, even if such a transaction would benefit other stockholders.

We have operated as a private company and have no experience attempting to comply with public company obligations. Attempting to comply with these requirements will increase our costs and require additional management resources, and we still may fail to comply.

We will face increased legal, accounting, administrative and other costs and expenses as a public company. Compliance with the Sarbanes-Oxley Act of 2002, the Dodd-Frank Act of 2010, as well as rules of the Securities and Exchange Commission and Nasdaq, for example, will result in significant initial cost to us as well as ongoing increases in our legal, audit and financial compliance costs, particularly after we are no longer an “emerging growth company.” The Exchange Act will require, among other things, that we file annual, quarterly and current reports with respect to our business and financial condition. Our management and other personnel will need to devote a substantial amount of time to these compliance initiatives. Moreover, we expect these rules and regulations to make it more difficult and more expensive for us to obtain director and officer liability insurance, and we may be required to incur substantial costs to maintain the same or similar coverage.

As a public company, we expect to become subject to Section 404 of the Sarbanes-Oxley Act relating to internal controls over financial reporting and we expect to incur significant expense and devote substantial management effort toward ensuring compliance with Section 404. We currently do not have an internal audit group, and we will need to hire additional accounting and financial staff with appropriate public company experience and technical accounting knowledge. Implementing any appropriate changes to our internal controls may require specific compliance training for our directors, officers and employees, entail substantial costs to modify our existing accounting systems, and take a significant period of time to complete. Such changes may not, however, be effective in maintaining the adequacy of our internal controls, and any failure to maintain that adequacy, or consequent inability to produce accurate consolidated financial statements or other reports on a timely basis, could increase our operating costs and could materially impair our ability to operate our business. We cannot assure you that our internal controls over financial reporting will prove to be effective.

If we fail to maintain proper and effective internal control over financial reporting in the future, our ability to produce accurate and timely financial statements could be impaired, which could harm our operating results, investors’ views of us and, as a result, the value of our common stock.

Pursuant to Section 404 of the Sarbanes-Oxley Act, our management will be required to report upon the effectiveness of our internal control over financial reporting beginning with the annual report for our fiscal year ending March 31, 2027. When and if we are a “large accelerated filer” or an “accelerated filer” and are no longer an “emerging growth company,” each as defined in the Exchange Act, our independent registered public accounting firm will be required to attest to the effectiveness of our internal control over financial reporting. However, for so long as we remain an emerging growth company, we intend to take advantage of an exemption available to emerging growth companies from these auditor attestation requirements. The rules governing the standards that must be met for management to assess our internal control over financial reporting are complex and require significant documentation, testing, and possible remediation. To comply with the requirements of being a reporting company under the Exchange Act, we will need to upgrade our systems including information technology; implement additional financial and management controls, reporting systems, and procedures; and hire additional accounting and finance staff. If we or, if required, our auditors are unable to conclude that our internal control over financial reporting is effective, investors may lose confidence in our financial reporting, and the trading price of our common stock may decline.

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

We are an emerging growth company, as defined in the Jumpstart Our Business Startups Act of 2012, or the JOBS Act and are eligible to take advantage of certain exemptions from various reporting requirements that are applicable to other public companies that are not emerging growth companies, including, but not limited to, only two years of audited financial statements in addition to any required unaudited interim financial statements with correspondingly reduced “Management’s Discussion and Analysis of Financial Condition and Results of Operations” disclosure, not being required to comply with the auditor attestation requirements of Section 404 of the Sarbanes-Oxley Act of 2002, or the Sarbanes-Oxley Act, reduced disclosure obligations regarding executive compensation in this prospectus and our periodic reports and proxy statements, exemptions from the requirements of holding non-binding advisory votes on executive compensation and seeking stockholder approval of any golden parachute payments not previously approved and not being required to adopt certain accounting standards until those standards would otherwise apply to private companies. We could be an emerging growth company until the last day of the fiscal year following the fifth anniversary of this offering, although circumstances could cause us to lose that status earlier, including if we become a large accelerated filer (in which case we will cease to be an emerging company as of the date we become a large accelerated filer, which, generally, would occur if, at the end of a fiscal year, among other things, the market value of our common stock that is held by non-affiliates exceeds $700 million as of the last business day of our most recently completed second fiscal quarter), if we have total annual gross revenue of $1.235 billion or more during any fiscal year (in which cases we would no longer be an emerging growth company as of March 31 of such fiscal year), or if we issue more than $1.0 billion in non-convertible debt during any three year period before that time (in which case we would cease to be an emerging growth company immediately). Even after we no longer qualify as an emerging growth company, we may still qualify as a “smaller reporting company,” which would allow us to take advantage of many of the same exemptions from disclosure requirements including not being required to comply with the auditor attestation requirements of Section 404 of the Sarbanes-Oxley Act and reduced disclosure obligations regarding executive compensation in this prospectus and our periodic reports and proxy statements. We cannot predict if investors will find our common stock less attractive because we may rely on these exemptions. If some investors find our common stock less attractive as a result, there may be a less active trading market for our common stock and our stock price may be more volatile.

Our Common Share price may be volatile and as a result you could lose all or part of your investment.

In addition to volatility associated with equity securities in general, the value of your investment could decline due to the impact of any of the following factors upon the market price of the shares of common stock:

• disappointing results from our development efforts;

• decline in demand for our shares of common stock;

• downward revisions in securities analysts’ estimates or changes in general market conditions;

• technological innovations by competitors or in competing technologies;

• investor perception of our industry or our prospects; and

• general economic trends.

Stock markets in general have experienced extreme price and volume fluctuations, and the market prices of securities have been highly volatile. These fluctuations are often unrelated to operating performance and may adversely affect the market price of the shares of common stock. We and the underwriters will negotiate to determine the initial public offering price. You may not be able to resell your shares at or above the initial public offering price or at all.

An active, liquid trading market for our common stock may not develop, which may limit your ability to sell your shares.

Prior to this offering, there was no public market for our common stock. Although we have applied to list our common stock on the NASDAQ Capital Market under the symbol “STA,” an active trading market for our shares may never develop or be sustained following this offering. The initial public offering price will be determined by negotiations between us and the underwriters and may not be indicative of market prices of our common stock that will prevail in the open market after the offering. A public trading market having the desirable characteristics of depth, liquidity and

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orderliness depends upon the existence of willing buyers and sellers at any given time, such existence being dependent upon the individual decisions of buyers and sellers over which neither we nor any market maker has control. The failure of an active and liquid trading market to develop and continue would likely have a material adverse effect on the value of our common stock. The market price of our common stock may decline below the initial public offering price, and you may not be able to sell your shares of our common stock at or above the price you paid in this offering, or at all. An inactive market may also impair our ability to raise capital to continue to fund operations by selling shares and may impair our ability to acquire other companies or technologies by using our shares as consideration.

FINRA has adopted sales practice requirements, which may also limit a shareholder’s ability to buy and sell our shares of common stock.

FINRA has adopted rules that require that in recommending an investment to a customer, a broker-dealer must have reasonable grounds for believing that the investment is suitable for that customer. Prior to recommending speculative low-priced securities to their non-institutional customers, broker-dealers must make reasonable efforts to obtain information about the customer’s financial status, tax status, investment objectives and other information. Under interpretations of these rules, FINRA believes that there is a high probability that speculative low-priced securities will not be suitable for at least some customers. FINRA requirements make it more difficult for broker-dealers to recommend that their customers buy our shares of common stock, which may limit your ability to buy and sell our stock and have an adverse effect on the market for our shares.

Investors’ interests in our common stock will be diluted and investors may suffer dilution in their net book value per share of common stock if we issue additional employee/director/consultant options or if we sell additional shares of common stock and/or warrants to finance our operations.

In order to further expand our operations and meet our objectives, any additional growth and/or expanded development activity will likely need to be financed through sale of and issuance of additional shares of common stock. Furthermore, to finance any acquisition activity, should that activity be properly approved, and depending on the outcome of our development programs, we likely will also need to issue additional shares of common stock to finance future acquisitions, growth, and/or additional exploration programs of any or all of our projects. We will also in the future grant to some or all of our directors, officers, and key employees and/or consultants’ options to purchase shares of common stock as non-cash incentives. The issuance of any equity securities could, and the issuance of any additional shares of common stock will, cause our existing stockholders to experience dilution of their ownership interests.

If we issue additional shares of common stock or decide to enter into joint ventures with other parties in order to raise financing through the sale of equity securities, investors’ interests in our company will be diluted and investors may suffer dilution in their net book value per share of common stock depending on the price at which such securities are sold.

Substantial amounts of our outstanding shares may be sold into the market when the lock-up period ends. If there are substantial sales of shares of our common stock, the price of our common stock could decline.

Sales of a substantial number of shares of our common stock in the public market or the perception that these sales might occur could significantly reduce the market price of our common stock and impair our ability to raise adequate capital through the sale of additional equity or equity-linked securities. After this offering, we will have 38,694,386 outstanding shares of our common stock, based on the number of shares outstanding as of December 1, 2025, assuming no exercise of the underwriters’ over-allotment option sold in this offering and no exercise of outstanding options. Of these shares, the 6,666,667 shares of common stock sold in this offering by us, plus any shares sold upon exercise of the underwriters’ over-allotment option, plus shares of common stock held by non-affiliates, will be freely tradeable, without restriction, in the public market immediately following this offering, unless they are purchased by one of our affiliates.

Our directors, executive officers and holders of more than 5.0% of our outstanding shares of common stock or securities convertible into or exchangeable for shares of our common stock have entered into lock-up agreements with the representatives pursuant to which they may not, with limited exceptions, for a period of 180 days from the date of this prospectus, offer, sell or otherwise transfer or dispose of any of our securities, without the prior written consent of the representative of the underwriters. Sales of these shares, or perceptions that they will be sold, could cause the trading price of our common stock to decline. After the lock-up agreements expire, up to an additional shares of common stock will be eligible for sale in the public market, of which shares will be held by directors, executive

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officers and other affiliates and will be subject to volume limitations under Rule 144 under the Securities Act of 1933, as amended (the Securities Act), in each case based on shares of common stock outstanding as of December 1, 2025, and without giving effect to any potential purchases by such persons in this offering.

The issuance of additional shares of shares of common stock may negatively impact the trading price of our securities.

We have issued shares of common stock in the past and will continue to issue shares of common stock to finance our activities in the future. In addition, newly issued or outstanding options, warrants, and broker warrants to purchase shares of common stock may be exercised, resulting in the issuance of additional shares of common stock. Any such issuance of additional shares of common stock would result in dilution to our stockholders, and even the perception that such an issuance may occur could have a negative impact on the trading price of the shares of common stock.

We face risks related to compliance with corporate governance laws and financial reporting standards.

The Sarbanes-Oxley Act of 2002, as well as related new rules and regulations implemented by the SEC and the Public Company Accounting Oversight Board, require changes in the corporate governance practices and financial reporting standards for public companies. These laws, rules and regulations, including compliance with Section 404 of the Sarbanes-Oxley Act of 2002 relating to internal control over financial reporting, referred to as Section 404, materially increased our legal and financial compliance costs and made some activities more time-consuming and more burdensome.

If securities or industry analysts do not publish research, or publish inaccurate or unfavorable research, about our stock or business, the price of our common stock and trading volume could decline.

The trading market for our common stock will depend, in part, on the research and reports that securities or industry analysts publish about us or our business. Securities and industry analysts do not currently, and may never, publish research on our company. If no securities or industry analysts commence coverage of our company or if they cease to cover our company, the trading price for our stock would likely be negatively impacted. In the event that securities or industry analysts initiate coverage, if one or more of the analysts who cover us downgrade our stock or publish inaccurate or unfavorable research about our business, demand for our common stock could decrease and the price of our common stock could decline. In addition, if our operating results fail to meet the forecast of analysts, the price of our common stock would likely decline. If one or more of these analysts cease coverage of our company or fail to publish reports on us regularly, demand for our stock could decrease, which might cause the price of our common stock and trading volume to decline.

Compliance with public reporting requirements will affect the Company’s financial resources.

As a public company, we are subject to certain public reporting obligations as required by federal securities laws, regulations and agencies. The compliance with such reporting requirements will require us to incur significant legal, accounting and other administrative expenses. Additionally, it is a condition to the closing of this offering that the common stock offered hereby has been duly listed on Nasdaq, which means that we will be subject to additional rules and disclosure obligations as required by Nasdaq Capital Market, increasing compliance expenses further. The expenses we may incur will have a significant impact on our financial resources and may lead to a decrease in the value and price of our common stock.

In the event that our common stock is delisted from Nasdaq Capital Market, U.S. broker-dealers may be discouraged from effecting transactions in shares of our common stock because they may be considered penny stocks and thus be subject to the penny stock rules.

The SEC has adopted a number of rules to regulate “penny stock” that restricts transactions involving stock which is deemed to be penny stock. Such rules include Rules 3a51-1, 15g-1, 15g-2, 15g-3, 15g-4, 15g-5, 15g-6, 15g-7, and 15g-9 under the Exchange Act. These rules may have the effect of reducing the liquidity of penny stocks. “Penny stocks” generally are equity securities with a price of less than $5.00 per share (other than securities registered on certain national securities exchanges or quoted on Nasdaq Capital Market if current price and volume information with respect to transactions in such securities is provided by the exchange or system). Our shares of common stock may in the future constitute “penny stock” within the meaning of the rules. The additional sales practice and disclosure

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requirements imposed upon U.S. broker-dealers may discourage such broker-dealers from effecting transactions in shares of our common stock, which could severely limit the market liquidity of such shares of common stock and impede their sale in the secondary market.

A U.S. broker-dealer selling penny stock to anyone other than an established customer or “accredited investor” (generally, an individual with a net worth in excess of $1,000,000 or an annual income exceeding $200,000, or $300,000 together with his or her spouse) must make a special suitability determination for the purchaser and must receive the purchaser’s written consent to the transaction prior to sale, unless the broker-dealer or the transaction is otherwise exempt. In addition, the “penny stock” regulations require the U.S. broker-dealer to deliver, prior to any transaction involving a “penny stock”, a disclosure schedule prepared in accordance with SEC standards relating to the “penny stock” market, unless the broker-dealer or the transaction is otherwise exempt. A U.S. broker-dealer is also required to disclose commissions payable to the U.S. broker-dealer and the registered representative and current quotations for the securities. Finally, a U.S. broker-dealer is required to submit monthly statements disclosing recent price information with respect to the “penny stock” held in a customer’s account and information with respect to the limited market in “penny stocks”.

Stockholders should be aware that, according to the SEC, the market for “penny stocks” has suffered in recent years from patterns of fraud and abuse. Such patterns include (i) control of the market for the security by one or a few broker-dealers that are often related to the promoter or issuer; (ii) manipulation of prices through prearranged matching of purchases and sales and false and misleading press releases; (iii) “boiler room” practices involving high-pressure sales tactics and unrealistic price projections by inexperienced sales persons; (iv) excessive and undisclosed bid-ask differentials and markups by selling broker-dealers; and (v) the wholesale dumping of the same securities by promoters and broker-dealers after prices have been manipulated to a desired level, resulting in investor losses. Our management is aware of the abuses that have occurred historically in the penny stock market. Although we do not expect to be in a position to dictate the behavior of the market or of broker-dealers who participate in the market, management will strive within the confines of practical limitations to prevent the described patterns from being established with respect to our securities.

Delaware law and provisions in our bylaws could make a merger, tender offer or proxy contest difficult, thereby depressing the potential trading price of our common stock.

Our certificate of incorporation and bylaws that will be in effect immediately prior to the completion of this offering will contain provisions that could significantly reduce the value of our shares to a potential acquiror or delay or prevent changes in control or changes in our management without the consent of our board of directors. The provisions in our charter documents will include the following:

• a classified board of directors with three-year staggered terms, which may delay the ability of stockholders to change the membership of a majority of our board of directors;

• no cumulative voting in the election of directors, which limits the ability of minority stockholders to elect director candidates;

• the exclusive right of our board of directors, unless the board of directors grants such right to the stockholders, to elect a director to fill a vacancy created by the expansion of the board of directors or the resignation, death or removal of a director, which prevents stockholders from being able to fill vacancies on our board of directors;

• the required approval of at least 66-2/3% of the shares entitled to vote to remove a director for cause, and the prohibition on removal of directors without cause;

• the ability of our board of directors to authorize the issuance of shares of preferred stock and to determine the price and other terms of those shares, including preferences and voting rights, without stockholder approval, which could be used to significantly dilute the ownership of a hostile acquiror;

• the ability of our board of directors to alter our bylaws without obtaining stockholder approval;

• the required approval of at least 66-2/3% of the shares entitled to vote to adopt, amend or repeal our amended and restated bylaws or repeal the provisions of our certificate of incorporation regarding the election and removal of directors;

• a prohibition on stockholder action by written consent, which forces stockholder action to be taken at an annual or special meeting of our stockholders;

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• an exclusive forum provision providing that the Court of Chancery of the State of Delaware will be the exclusive forum for certain actions and proceedings;

• the requirement that a special meeting of stockholders may be called only by the board of directors, which may delay the ability of our stockholders to force consideration of a proposal or to take action, including the removal of directors; and

• advance notice procedures that stockholders must comply with in order to nominate candidates to our board of directors or to propose matters to be acted upon at a stockholders’ meeting, which may discourage or deter a potential acquiror from conducting a solicitation of proxies to elect the acquiror’s own slate of directors or otherwise attempting to obtain control of us.

We are also subject to the anti-takeover provisions contained in Section 203 of the Delaware General Corporation Law. Under Section 203, a corporation may not, in general, engage in a business combination with any holder of 15% or more of its capital stock unless the holder has held the stock for three years or, among other exceptions, the board of directors has approved the transaction.

Our certificate of incorporation and bylaws provide that the Court of Chancery of the State of Delaware shall be the exclusive forum for certain disputes between us and our stockholders, which could limit our stockholders’ ability to obtain a favorable judicial forum for disputes with us or our directors, officers or employees.

Our certificate of incorporation and bylaws provide that the Court of Chancery of the State of Delaware is the exclusive forum for any derivative action or proceeding brought on our behalf, any action asserting a claim of breach of fiduciary duty, any action asserting a claim against us arising pursuant to the Delaware General Corporation Law, our certificate of incorporation or our bylaws, or any action asserting a claim against us that is governed by the internal affairs doctrine; provided that, the exclusive forum provision will not apply to suits brought to enforce any liability or duty created by the Exchange Act or any other claim for which the federal courts have exclusive jurisdiction; and provided further that, if and only if the Court of Chancery of the State of Delaware dismisses any such action for lack of subject matter jurisdiction, such action may be brought in another state or federal court sitting in the State of Delaware. Nothing in our certificate of incorporation and bylaws precludes stockholders that assert claims under the Exchange Act from bringing such claims in state or federal court, subject to applicable law. Our certificate of incorporation also provides that the federal district courts of the United States of America will be the exclusive forum for resolving any complaint asserting a cause of action arising under the Securities Act. The exclusive forum provision will be applicable to the fullest extent permitted by applicable law, subject to certain exceptions. Section 27 of the Exchange Act creates exclusive federal jurisdiction over all suits brought to enforce any duty or liability created by the Exchange Act or the rules and regulations thereunder. As a result, the exclusive forum provision will not apply to suits brought to enforce any duty or liability created by the Exchange Act or any other claim for which the federal courts have exclusive jurisdiction. It should be noted, however, that there is uncertainty as to whether a court would enforce this provision and that investors cannot waive compliance with the federal securities laws and the rules and regulations thereunder. Section 22 of the Securities Act creates concurrent jurisdiction for state and federal courts over all suits brought to enforce any duty or liability created by the Securities Act or the rules and regulations thereunder.

Any person or entity purchasing or otherwise acquiring any interest in any of our securities will be deemed to have notice of and consented to this provision. This choice of forum provision may limit a stockholder’s ability to bring a claim in a judicial forum that it finds favorable for disputes with us or any of our directors, officers, other employees or stockholders, or could result in increased costs for a stockholder to bring a claim, particularly if they do not reside in or near Delaware, both of which may discourage lawsuits with respect to such claims, although our stockholders will not be deemed to have waived our compliance with federal securities laws and the rules and regulations thereunder. Furthermore, the enforceability of similar choice of forum provisions in other companies’ certificates of incorporation has been challenged in legal proceedings, and it is possible that a court could find these types of provisions to be inapplicable or unenforceable. While the Delaware courts have determined that such choice of forum provisions are facially valid, a stockholder may nevertheless seek to bring a claim in a venue other than those designated in the exclusive forum provisions, and there can be no assurance that such provisions will be enforced by a court in those other jurisdictions. If a court were to find the choice of forum provision that will be contained in our certificate of incorporation and bylaws to be inapplicable or unenforceable in an action, we may incur additional costs associated with resolving such action in other jurisdictions, which could adversely affect our business and financial condition.

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MARKET AND INDUSTRY DATA

We obtained the industry, market and competitive position data used throughout this prospectus from our own internal estimates and research, as well as from industry and general publications, and research, surveys and studies conducted by third parties. Internal estimates are derived from publicly available information released by industry analysts and third-party sources, our internal research and our industry experience, and are based on assumptions made by us based on such data and our knowledge of the industry and market, which we believe to be reasonable. In addition, while we believe the industry, market and competitive position data included in this prospectus is reliable and based on reasonable assumptions, we have not independently verified any third-party information, and all such data involve risks and uncertainties and are subject to change based on various factors, including those discussed in “Risk Factors.” These and other factors could cause results to differ materially from those expressed in the estimates made by the independent parties and by us. In some cases, we do not expressly refer to the sources from which this data is derived. In that regard, when we refer to one or more sources of this type of data in any paragraph, you should assume that other data of this type appearing in the same paragraph is derived from the same sources, unless otherwise expressly stated or the context otherwise requires.

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USE OF PROCEEDS

We estimate that the net proceeds to us from the sale of shares of our shares of common stock in this offering will be approximately $37,200,000, based upon the assumed initial public offering price of $6.00 per share, which is the midpoint of the estimated offering price range set forth on the cover page of this prospectus, and after deducting estimated underwriting discounts and commissions and estimated offering expenses payable by us. If the underwriter’s over-allotment option to purchase additional shares of common stock from us is exercised in full, we estimate that the net proceeds to us would be approximately $42,780,000, after deducting estimated underwriting discounts and commissions and estimated offering expenses payable by us. We intend to use the majority of the net proceeds from the offering to support product development activities for our leading drug delivery candidates, including conducting clinical development and managing our regulatory affairs for our product candidates; and for working capital and other general corporate purposes, including payment of certain outstanding trade payables and amounts due and owing to related parties.

We currently expect to use the net proceeds from this offering as follows:

• approximately $ to advance Phase 1 clinical development of STAR-LLD in CLL;

• approximately $ to advance Phase 2 clinical development of STAR-LLD in MM;

• approximately $ to fund several IIT studies at major academic centers of STAR-LLD in combinations with CAR-T cell therapies in MM and lymphoma;

• approximately $ to pay certain outstanding trade payables and amounts due and owing to related parties for goods and services rendered to us. See “Certain Relationships and Related Transactions, and Director Independence — Deferred Consulting and Service Fees;”

• the balance of approximately $ to fund 1 year of working capital and other general corporate purposes.

Each $1.00 increase or decrease in the assumed initial public offering price of $6.00 per share, which is the midpoint of the estimated offering price range set forth on the cover page of this prospectus, would increase or decrease the net proceeds that we receive from this offering by approximately $6.7 million, assuming that the number of shares offered by us, as set forth on the cover page of this prospectus, remains the same and after deducting the estimated underwriting discounts and commissions payable by us. Similarly, each increase or decrease of 1.0 million in the number of shares of our shares of common stock offered by us would increase or decrease the net proceeds that we receive from this offering by approximately $6.0 million, assuming the assumed initial public offering price remains the same and after deducting the estimated underwriting discounts and commissions payable by us.

The principal purposes of this offering are to increase our capitalization and financial flexibility, create a public market for our shares of common stock, and enable access to the public equity markets for us and our stockholders.

Based on our current plans, we believe that the net proceeds from this offering, together with our existing cash, will be sufficient to fund our operations through 2026.

The net proceeds from this offering, together with our existing cash and cash equivalents, are expected to fully fund the Phase 2a multiple myeloma clinical trial in relapsed/refractory patients (second line and higher) and allow us to initiate a Phase 1 study in CLL for STAR-LLD; however, they are not expected to be sufficient to complete Phase 3 clinical studies or to seek NDA’s for commercialization for STAR-LLD or to pursue further clinical studies for other potential pipeline programs, and we will need to raise substantial additional capital to complete the development of this or any other product candidate. See section entitled “Risk Factors” starting on page 12.

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STOCK SPLIT

On December 9, 2025, we effected a 3 for 1 stock split. The stock split affects all of our stockholders uniformly and did not affect any stockholder’s percentage ownership interest in us. Unless otherwise indicated, and other than the consolidated financial statements and the related notes included elsewhere in this prospectus, information presented in this prospectus is adjusted to reflect our 3 for 1 stock split.

DIVIDEND POLICY

We have never declared or paid cash dividends on our capital stock and have no present intention to pay cash dividends on our common stock for the foreseeable future. Any determination to pay dividends to holders of our common stock will be at the discretion of our board of directors and will depend on many factors, including our financial condition, results of operations, liquidity, earnings, projected capital and other cash requirements, legal requirements, restrictions in the agreements governing any indebtedness we may enter into, business prospects and other factors that our board of directors deems relevant. Investors should not purchase our common stock with the expectation of receiving cash dividends.

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DOMESTICATION TRANSACTIONS

Prior to our corporate reorganization, which was consummated on November 5, 2025, our equity owners held their ownership interests in our subsidiary (and former holding company) Starton Therapeutics Inc., a corporation incorporated under the Business Corporations Act (British Columbia) (“Starton Canada”), which in turn held all of the equity interests in our operating company, Starton Therapeutics, Inc., a Delaware corporation.

As a result of our corporate reorganization, we now own directly or indirectly, Starton Callco ULC, a British Columbia unlimited liability company (“CallCo”), Starton Exchangeco Inc., a British Columbia corporation (“Exchangeco”), Starton Canada, and Starton Therapeutics, Inc., a Delaware corporation. All of our equity owners own all of their equity interests only in our capital stock or in shares of Exchangeco that are exchangeable for our capital stock.

In connection with our corporate reorganization, Exchangeco issued 9,999,019 shares in the capital stock of Exchangeco (“Exchangeable Shares”) to certain Canadian equity owners in Starton Canada in exchange for their shares in Starton Canada with the intention of allowing the Rollover Shareholders to continue deferring tax in Canada following our corporate reorganization for as long as they continue to own Exchangeable Shares. The Exchangeable Shares are exchangeable for shares of our common stock. Holders of Exchangeable Shares also received shares of our special voting stock, which provide the holders of Exchangeable Shares with certain voting rights, by way of a voting trustee, with respect to matters on which holders of shares of our common stock are entitled to vote. The Exchangeable Shares and special voting stock are intended to be the economic and voting equivalent of shares of our common stock.

The following information describes in more detail our current capital structure immediately after our corporate reorganization. The diagrams included in this section are simplified illustrations that summarize our capital structure and are intended only as a supplement to, and not a substitute for, the following information regarding our corporate reorganization.

Post-Reorganization Capitalization

Prior to the completion of this offering, we will have outstanding and reserved for issuance:

• 31,694,386 shares of our common stock;

• 9,999,019 shares of our special voting stock;

• 7,488,778 shares of our common stock issuable upon the exercise, if at all, of Options to purchase 7,488,778 shares of our common stock; and

• 9,999,019 shares of our common stock issuable in the future, if at all, upon the exchange of an equal number of exchangeable shares of Exchangeco.

The former stockholders of Starton Canada through their ownership of Exchangeable Shares of Exchangeco will be the only group of persons who will have an interest in one of our subsidiaries.

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Corporate Structure

Set forth below is a diagram that graphically illustrates, in simplified form, our current corporate structure (following our November 2025 corporate reorganization), prior to the completion of this offering.

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CAPITALIZATION

The following table sets forth our cash as well as our capitalization, as of September 30, 2025 as follows:

• on an actual basis;

• on a pro forma as adjusted basis, giving effect to the sale and issuance by us of 6,666,667 shares of our shares of common stock in this offering, based upon the assumed initial public offering price of $6.00 per share, which is the midpoint of the estimated offering price range set forth on the cover page of this prospectus, after deducting estimated underwriting discounts and commissions and estimated offering expenses payable by us.

The pro forma as adjusted information set forth in the table below is illustrative only and will be adjusted based on the actual initial public offering price and other terms of this offering determined at pricing. You should read this table together with our consolidated financial statements and related notes, and the sections titled “Selected Consolidated Financial and Other Data” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” that are included elsewhere in this prospectus.

	As of September 30, 2025
	Actual(1)			Pro Forma(2)			Pro Forma as adjusted(3)(4)
Cash	$	1,071,148			36,738,908		$	37,810,056
Stockholders’ deficit:
Common stock, $0.001 par value, 200,000,000 shares authorized (31,318,722 issued and outstanding actual and 37,985,389 pro forma and pro forma as adjusted)		55,207,913			(55,169,928	)		37,985
Common stock subscriptions		—			—			—
Additional paid-in capital		22,453,163			92,369,928			114,823,091
Accumulated other comprehensive loss		(119,338	)		—			(119,338	)
Accumulated stockholders’ deficit		(80,889,839	)		—			(80,889,839	)
Total stockholder’s equity (deficit)	$	(3,348,101	)	$	37,200,000		$	33,851,899

____________

(1) The actual capitalization data represents the historical capitalization data of Starton Therapeutics, Inc. as of September 30, 2025. In connection with the Domestication Transactions in November 2025, Starton Holdings, Inc. became the parent company of Starton Therapeutics, Inc.

(2) The proforma as adjusted capitalization data represents the capitalization data of Starton Holdings, Inc. and reflects the pro forma adjustments described in footnote (1) to this table and the issuance and sale by us of 6,666,667 shares of our common stock in this offering, after deducting the estimated underwriting discounts and commissions and estimated offering expenses payable by us, at an assumed initial public offering price of $6.00 per share, which is the midpoint of the price range set forth on the cover page of this prospectus.

(3) Each $1.00 increase or decrease in the assumed initial public offering price of $6.00 per share, which is the midpoint of the estimated offering price range set forth on the cover page of this prospectus, would increase or decrease, as applicable, the amount of our pro forma as adjusted cash, additional paid-in capital, total stockholders’ equity (deficit), and total capitalization by $6.2 million, assuming that the number of shares offered by us, as set forth on the cover page of this prospectus, remains the same, and after deducting estimated underwriting discounts and commissions payable by us. An increase or decrease of 1.0 million shares in the number of shares offered by us would increase or decrease, as applicable, the amount of our pro forma as adjusted cash, additional paid-in capital, total stockholders’ equity (deficit), and total capitalization by $5.6 million, assuming the assumed initial public offering price remains the same, and after deducting estimated underwriting discounts and commissions payable by us.

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If the underwriters’ over-allotment option to purchase additional shares of our shares of common stock from us were exercised in full, pro forma as adjusted cash, additional paid-in capital, total stockholders’ equity (deficit), total capitalization, and shares outstanding as of September 30, 2025 would be $37,810,056, $114,823,091, $33,851,899, $71,661,955, and 37,985,389, respectively.

The number of shares of our shares of common stock that will be outstanding after this offering is based on 31,318,722 shares of our shares of common stock outstanding as of September 30, 2025; however, it excludes the following:

• 7,488,778 shares of common stock issuable upon the exercise of outstanding stock options as of September 30, 2025, issued under our 2025 Omnibus Equity Incentive Plan;

• 844,555 shares of common stock reserved for issuance pursuant to future awards under our Omnibus Equity Incentive Plan;

• 333,333 shares of common stock that may be issued upon the exercise by the underwriters’ of their warrants; and

• 9,999,019 shares of special voting stock issued in connection with our corporate reorganization equal to the number of exchangeable shares that are issued by Exchangeco in our corporate reorganization.

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DILUTION

If you invest in shares of our common stock in this offering, your ownership interest will be diluted to the extent of the difference between the initial public offering price per share of our common stock and the pro forma as adjusted net tangible book value per share of our common stock immediately after this offering. Net tangible book value dilution per share to new investors represents the difference between the amount per share paid by purchasers of shares of our common stock in this offering and the pro forma as adjusted net tangible book value per share of our Common immediately after completion of this offering.

Net tangible book value per share is determined by dividing our total assets, less our net intangible assets, our total liabilities and the value of our total convertible preferred stock by the number of shares of our common stock outstanding. Our historical net tangible book value as of September 30, 2025 was $3.3 million, or $0.11 per share. Our pro forma net tangible book value as of September 30, 2025 was $33.4 million, or $0.73 per share, based on the total number of shares of our common stock outstanding as of September 30, 2025 after giving effect to our corporate reorganization as described in “Domestication Transactions” included elsewhere in this prospectus, and assuming the exchange, for shares of our common stock, of all the exchangeable shares of Exchangeco to be issued in connection with our corporate reorganization.

After giving effect to the sale by us of 6,666,667 shares of our common stock in this offering at the assumed initial public offering price of per share, which is the midpoint of the estimated offering price range set forth on the cover page of this prospectus, and after deducting estimated underwriting discounts and commissions and estimated offering expenses payable by us, our pro forma as adjusted net tangible book value as of September 30, 2025 would have been $33.4 million, or $0.73 per share. This represents an immediate increase in pro forma net tangible book value of $0.84 per share to our existing stockholders and an immediate dilution in pro forma net tangible book value of $5.27 per share to investors purchasing shares of our common stock in this offering at the assumed initial public offering price. The following table illustrates this dilution:

	No exercise of over-allotment option			Exercise of over-allotment option in full
Assumed Initial public offering price per share	$	6.00		$	6.00
Historical net tangible book value per share as of September 30, 2025		(0.11	)		(0.11	)
Increase in pro forma net tangible book value per share attributable to new investors purchasing shares of our common stock in this offering		0.84			0.94
Pro forma net tangible book value per share as of September 30, 2025		0.73			0.83
Dilution in pro forma net tangible book value per share to new investors in this offering	$	5.27		$	5.17

Each $1.00 increase or decrease in the assumed initial public offering price of $6.00 per share, which is the midpoint of the estimated offering price range set forth on the cover page of this prospectus, would increase or decrease, as applicable, our pro forma as adjusted net tangible book value per share after this offering by $0.13, and would increase or decrease, as applicable, dilution per share to new investors purchasing shares of our common stock in this offering by $0.87, assuming that the number of shares offered by us, as set forth on the cover page of this prospectus, remains the same and after deducting estimated underwriting discounts and commissions and estimated offering expenses payable by us. Similarly, each increase or decrease of 1.0 million shares in the number of shares of our common stock offered by us would increase or decrease, as applicable, our pro forma as adjusted net tangible book value by approximately $0.10 per share and increase or decrease, as applicable, the dilution to new investors purchasing shares of our common stock in this offering by $0.10 per share, assuming the assumed initial public offering price remains the same, and after deducting underwriting discounts and commissions and estimated offering expenses payable by us.

If the underwriters’ over-allotment option to purchase additional shares of our common stock from us is exercised in full, the pro forma as adjusted net tangible book value per share of our common stock, as adjusted to give effect to this offering, would be $0.83 per share, and the dilution in pro forma net tangible book value per share to new investors purchasing shares of our common stock in this offering would be $5.17 per share.

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The following table presents, as of September 30, 2025, on a pro forma as adjusted basis as described above and after giving effect to the sale of shares of common stock by us in this offering at an assumed initial public offering price of $6.00 per share, which is the midpoint of the estimated offering price range set forth on the cover page of this prospectus, the differences between the existing stockholders and the new investors purchasing shares of our common stock in this offering with respect to the number of shares purchased from us, the total consideration paid or to be paid to us, which includes net proceeds received from the issuance of shares of our common stock and the average price per share paid or to be paid to us at the assumed initial public offering price of $6.00 per share, which is the midpoint of the estimated offering price range set forth on the cover page of this prospectus, before deducting estimated underwriting discounts and commissions and estimated offering expenses payable by us:

	Shares Purchased			Total Consideration			Average Price per Share
	Number	Percent		Amount		Percent	Average Price per Share
Existing stockholders	31,318,722	82.45	%	$	187,912,332	82%	$	6.00
New investors	6,666,667	17.55	%		40,000,000	18	$	6.00
Total	37,985,389	100.00	%	$	227,912,332	100%		6.00

Each $1.00 increase or decrease in the assumed initial public offering price of $6.00 per share, which is the midpoint of the estimated offering price range set forth on the cover page of this prospectus, would increase or decrease, as applicable, the total consideration paid by new investors and total consideration paid by all stockholders by approximately $6.2 million, assuming that the number of shares of our common stock offered by us, as set forth on the cover page of this prospectus, remains the same and after deducting estimated underwriting discounts and commissions and estimated offering expenses payable by us. Similarly, each increase or decrease of 1.0 million in the number of shares of our common stock offered by us would increase or decrease the total consideration paid by new investors and total consideration paid by all stockholders by approximately $5.6 million, assuming the assumed initial public offering price remains the same and after deducting the estimated underwriting discounts and commissions payable by us.

Except as otherwise indicated, the above discussion and tables assume no exercise of the underwriters’ over-allotment option to purchase additional shares of our common stock from us. If the underwriters’ over-allotment option to purchase additional shares of our Shares of our common stock were exercised in full, our existing stockholders would own 80% and our new investors would own 20% of the total number of shares of our common stock outstanding upon completion of this offering.

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SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS

This prospectus contains forward-looking statements, which are statements other than those of historical fact. These forward-looking statements include, among other things, statements about the parties’ ability to close the financial conditions, results of operations, earnings outlook and prospects of Starton. In addition, any statements that refer to projections, forecasts or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking statements. Forward-looking statements are typically identified by words such as “plan,” “believe,” “expect,” “anticipate,” “intend,” “outlook,” “estimate,” “forecast,” “project,” “continue,” “could,” “may,” “might,” “possible,” “potential,” “predict,” “should,” “would,” “will,” “seek,” and other similar words and expressions, but the absence of these words does not mean that a statement is not forward-looking.

These forward-looking statements are based on information available as of the date of this prospectus and on the current expectations, forecasts and assumptions of the management of Starton, involve a number of judgments, risks and uncertainties and are inherently subject to changes in circumstances and their potential effects and speak only as of the date of such statements. There can be no assurance that future developments will be those that have been anticipated. These forward-looking statements involve a number of risks, uncertainties or other assumptions that may cause actual results or performance to be materially different from those expressed, contemplated or implied by these forward-looking statements. These risks and uncertainties include, but are not limited to, those factors described in “Risk Factors,” and those discussed and identified in public filings made with the SEC by Starton.

Should one or more of these risks or uncertainties materialize or should any of the assumptions made by the management of Starton prove incorrect, actual results may vary in material respects from those projected in or contemplated by these forward-looking statements.

All subsequent written and oral forward-looking statements concerning other matters addressed in this prospectus and attributable to Starton or any person acting on their behalf are expressly qualified in their entirety by the cautionary statements contained or referred to in this prospectus. Except to the extent required by applicable law or regulation, Starton undertakes any obligation to update these forward-looking statements to reflect events or circumstances after the date of this prospectus or to reflect the occurrence of unanticipated events.

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

You should read the following discussion of our financial condition and results of operations in conjunction with our consolidated financial statements and the notes included elsewhere in this prospectus. The following discussion contains forward-looking statements that involve certain risks and uncertainties. Our actual results could differ materially from those discussed in these statements. Factors that could cause or contribute to these differences include those discussed below and elsewhere in this prospectus, particularly under the “Risk Factors” and “Special Note Regarding Forward-Looking Statements” sections.

Overview

We are a clinical-stage biotechnology company focused on improving standard-of-care therapies for people with cancer through application of our proprietary platform delivery technology systems. We use continuous delivery of FDA-approved, active ingredients in an attempt to develop and bring products to market in either new indications or with enhanced outcomes in existing indications. In collaboration with our consulting company, McKinsey & Company, we evaluated over 80,000 potential applications to identify those applications where we believed our continuous delivery platform would bring the most benefit to patients. Based on the results of that evaluation, we are focused initially on the treatment of hematologic malignancies (blood cancers).

Our lead program, STAR-LLD, is a continuous delivery system of the generic form of Revlimid® (lenalidomide), which is a prescription medicine owned by Bristol Myers Squibb that is currently used to treat adults with MM and certain lymphomas. With STAR-LLD, we are seeking to develop both a subcutaneous and an oral controlled release formulation in parallel to improve the probability of success. We are pursuing multiple indications in multiple myeloma and chronic lymphocytic leukemia, and potentially expanding in other cancers, including B cell lymphomas and solid tumors as well as in combination with CAR-T therapies.

Immunomodulatory drugs (IMiDs) are the mainstay of early treatment in a number of hematologic with a potential market of approximately $12 billion as of 2020. We believe our proprietary continuous delivery platform can potentially increase efficacy of approved drugs, make them more tolerable, and expand their potential use; however, we have not obtained regulatory approvals for our product candidates and there can be no assurances that we will obtain regulatory approval in the time frame we anticipate or ever. Our strategic platforms aim to provide a controlled, sustained release. The use of the continuous delivery of lenalidomide allows for lower peaks and higher troughs which provide therapeutic blood levels for the entirety of the dosing interval whereas once-daily oral dosing is associated with sub-therapeutic blood levels of lenalidomide during each day’s dosing.

We have conducted a proof-of-concept study in a mouse model of multiple myeloma, in which the STAR-LLD continuous infusion versus lenalidomide standard of care. Specifically, the tumor volume increase on day 29 was 483% with standard of care versus a-81% reduction in tumor volume in the STAR-LLD group. A delay in the tumor progression was also increased in the continuous infusion group as STAR-LLD.

We have conducted a Phase 1b clinical trial (low-dose lenalidomide STAR-LLD) that yielded positive interim top-line data in relapsed or refractory multiple myeloma (RRMM). The Phase 1b was completed and top-line data has been presented to the FDA. The study was designed to assess the safety, pharmacokinetics, and efficacy of the Company’s STAR-LLD in combination with dexamethasone and bortezomib (Velcade®), and met the primary safety objective while being administered by continuous subcutaneous (SC) infusion. All six patients achieved a partial response (PR) or better.

Since our inception in 2017, we have devoted substantially all of our resources to organizing and staffing our company, acquiring the rights to develop our leading drug delivery candidates, clinical development of our leading candidates, raising capital, identifying potential product candidates, enhancing our intellectual property portfolio and undertaking research and clinical and preclinical studies for our development programs. We do not have any products

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approved for sale and have not generated any product revenue. We have funded our operations to date primarily through the private placement of our common stock. As of September 30, 2025, we received gross proceeds of approximately $48.5 million from the issuance of our common stock and had cash of $1,071,148.

Financial Operations Overview

Revenue

We did not realize any revenue during the years ended March 31, 2025 or March 31, 2024.

Costs and Expenses

Our costs and expenses are primarily the result of the following activities: development of our pipeline of proprietary product candidates; and general and administrative expenses including stock-based compensation. We record our costs and expenses in the following categories:

Research and Development Expenses

The successful development of our current and future product candidates is highly uncertain. This is due to the numerous risks and uncertainties, including the following:

• successful completion of preclinical studies and clinical trials;

• delays in regulators or institutional review boards authorizing us or our investigators to commence our clinical trials or in our ability to negotiate agreements with clinical trial sites or CROs;

• the number and location of clinical sites included in the trials;

• raising additional funds necessary to complete clinical development of our product candidates;

• obtaining and maintaining patent, trade secret and other intellectual property protection and regulatory exclusivity for our product candidates;

• contracting with third-party manufacturers for clinical supplies of our product candidates

• protecting and enforcing our rights in our intellectual property portfolio including, if necessary, litigation; and

• maintaining a continued acceptable safety profile of the products following approval.

We expect our research and development expenses to continue to be significant over the next several years as we develop and/or acquire additional product candidates and technologies. We may hire or engage additional skilled colleagues or third parties to perform these activities, conduct clinical trials and ultimately seek regulatory approval for any product candidate that successfully completes those clinical trials.

In addition, the probability of success for each product candidate will depend on numerous factors, including regulatory approval, competition, manufacturing capability and commercial viability. We will determine which programs to pursue and how much to fund each program in response to the scientific and clinical success of each product candidate, as well as an assessment of each product candidate’s commercial potential.

General and Administrative Expenses

General and administrative expenses consist of salaries, benefits, stock-based compensation and other related costs. Other costs include professional fees for patent-related and other legal expenses, consulting, tax and accounting services; insurances; depreciation and general corporate expenses.

The Company expects to incur additional general and administrative costs as a result of being a publicly traded company, including expenses to comply with the rules and regulations of the SEC and NASDAQ, as well as higher expenses for corporate insurance, director and officer insurance, investor relations, and professional services.

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Results of Operations

Comparison of the Year Ended March 31, 2025 and 2024

	Year ended March 31,
	2025			2024
Operating expenses:
Research and development	$	5,727,733		$	4,796,926
Research and development – related party		1,828,781			1,919,675
General and administrative		6,683,621			8,180,819
General and administrative – related party		72,000			100,630
Total operating expenses		14,312,135			14,998,050
Operating loss		(14,312,135	)		(14,998,050	)

Other income (expense):
Interest income, net		10,238			39
Interest expense – related party		—			—
Realized gain on sale of assets		5,000,000			—
Loss on disposal of patents		(168,370	)		—
Other income (expense)		(7,702	)		—
Loss before taxes		(9,477,969	)		(14,998,011	)
Income tax benefit		—			3,460

Net loss	$	(9,477,969	)		(14,994,551	)

Net loss per common share – basic and diluted	$	(0.11	)		(0.18	)

Weighted average common shares – basic and dilutive		89,886,805			85,414,789

Net loss	$	(9,477,969)			(14,994,551	)
Other comprehensive income (loss):
Foreign currency translation adjustments		2,869			(45,795	)
Comprehensive loss		(9,475,100	)		(15,040,346	)

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Comparison of the six months ended September 30,2025

	Six Months ended September 30,
	2025			2024
Operating expenses:
Research and development	$	2,730,968			2,887,274
Research and development – related party		823,425			899,213
General and administrative		3,466,616			3,445,479
General and administrative – related party		36,000			36,000
Total operating expenses		7,057,009			7,267,966
Operating loss		(7,057,009	)		(7,267,966	)

Other income:
Interest income, net		3,470			6,237
Interest expense – related party		(9,526	)		—
Other income (expense)		(80	)		6,237
Total other income		(6,136	)		6,237
Loss before taxes		(7,063,145	)		(7,261,729	)
Income tax benefit		—			—

Net loss	$	(7,063,145	)	$	(7,261,729	)

Net loss per common share – basic and diluted	$	(0.08	)	$	(0.08	)

Weighted average common shares – basic and diluted		93,341,267			88,545,547

Net loss	$	(7,063,145	)		(7,261,729	)
Other comprehensive income:
Foreign currency translation adjustments		(14,523	)		(10,141	)
Comprehensive loss	$	(7,077,668	)	$	(7,271,870	)

Research and Development Expense

The following table summarizes our research and development expenses for the years ended March 31, 2025 and 2024:

	Year Ended March 31,				Change
	2025		2024		Change
STAR-LLD (lenalidomide) program:
Salary and related expenses	$	717,006	$	1,134,183	$	(417,177	)
Clinical studies		1,534,706		1,193,455		341,252
Laboratory expenses		900,000		1,181,803		(281,803	)
Consulting fees		688,934		731,419		(42,485	)
Other		196,007		574,009		(378,003	)
Total STAR-LLD (lenalidomide) program:		4,036,653		4,814,869		(778,216	)
Other research and development
Stock based compensation	$	1,622,956	$	1,622,142	$	814
Other		1,896,903		279,592		1,617,311
Total Other research and development:		3,519,859		1,901,734		1,618,125
Total research and development expenses:	$	7,556,512	$	6,716,603	$	839,909

The primary focus of our research and development efforts has been on the continued testing and development of our lenalidomide program. Research and development expenses were $7.6 million for the year ended March 31, 2025, consisting of approximately $4.0 million for our lenalidomide program $1.6 million for stock based compensation and

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$2.0 million for other research and development expenses that are not delineated and operating expenses associated with research and development. This compares to expenditures of $6.7 million for the year ended March 31, 2024, consisting of $4.8 million for our lenalidomide program, $1.6 million for stock based compensation and $0.3 million for other research and development expenses. The increase of $0.9 million, or 15.5%, was primarily due to costs associated with the Phase 1b clinical trial of lenalidomide.

The following table summarizes our research and development expenses for the six months ended September 30, 2025 and 2024:

	Six Months Ended September 30,				Change
	2025		2024		Change
STAR-LLD (lenalidomide) program:
Salary and related expenses	$	270,726	$	401,557	$	(130,831	)
Clinical studies		852,528		757,047		95,480
Laboratory expenses		540,000		360,000		180,000
Consulting fees		308,593		371,063		(62,470	)
Other		12,767		116,071		(103,304	)
Total STAR-LLD (lenalidomide) program:		1,984,613		2,005,737		(21,124	)
Other research and development
Stock based compensation		813,724		840,922		(27,198	)
Other		756,056		939,828		(183,772	)
Total Other research and development:		1,569,780		1,780,750		(210,970	)
Total research and development expenses:	$	3,554,393	$	3,786,487	$	(232,094	)

Research and development expenses were approximately 3.6 million for the six months ended September 30, 2025, as compared to approximately 3.8 million for the six months ended September 30, 2024, resulting from various lenalidomide-related projects.

General and Administrative Expense

General and administrative expenses were $6.8 million for the year ended March 31, 2025, as compared to $8.3 million for the year ended March 31, 2024. The decrease of $1.5 million, or 18.1%, is due to decreased professional fees for services and facilities and other expenses.

General and administrative expenses were $3.5 million for the six months ended September 30, 2025, as compared to $3.4 million for the six months ended September 30, 2024.

Liquidity and Capital Resources

Overview

We have historically sourced our liquidity requirements primarily with cash flow from financing activities, such as equity issuances. To date, we have raised gross proceeds of approximately $48.5 million from the issuance of common stock. As of September 30, 2025, we had cash of $1,071,148.

Sources of Liquidity

		Six Months ended September 30,
		2025

Starton Holdings, Inc. S-1