As filed with the Securities and Exchange Commission on December 12, 2025.

Registration Statement No. 333-

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

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

__________________________________

Invea Therapeutics, Inc.

(Exact name of registrant as specified in its charter)

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Delaware		2834		87-3198325
(State or other jurisdiction of incorporation or organization)		(Primary Standard Industrial Classification Code Number)		(I.R.S. Employer Identification Number)

2614 Boston Post Road, Suite 33B
Guilford, Connecticut 06437
(203) 643-8002
(Address, including zip code, and telephone number of registrant’s principal executive offices)

__________________________________

Krishnan Nandabalan, Ph.D.
Chief Executive Officer and Chairman
Invea Therapeutics, Inc.
2614 Boston Post Road, Suite 33B
Guilford, Connecticut 06437
(203) 643 8002
(Name, address, including zip code, and telephone number, including area code, of agent for service)

__________________________________

Copies to:

Merrill M. Kraines
Todd Kornfeld
McDermott Will & Schulte LLP
One Vanderbilt Avenue
New York, New York 10017-3852
Tel: +1.212.547.5616

Oded Har-Even
Ron Ben-Bassat
Sullivan & Worcester LLP
1251 Avenue of the Americas
New York, NY 10020

Tel: +1.212.660.3000

__________________________________

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

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

If this Form is filed to register additional securities for an offering pursuant to Rule 462(b) under the Securities Act, 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 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 the registration statement shall become effective on such date as the Securities and Exchange 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 state where the offer or sale is not permitted.

Preliminary prospectus

Subject to Completion

Dated DECEMBER , 2025

Shares
Common Stock

Invea Therapeutics, Inc.

This is a firm commitment initial public offering of shares of common stock, par value $0.0001 per share, of Invea Therapeutics, Inc. The anticipated initial public offering price will be between $ and $ per share of common stock. The number of shares of common stock offered hereby is based upon an assumed public offering price of $ per share of common stock, the midpoint of such estimated price range. For a discussion of the factors to be considered in determining the initial public offering price of the common stock, see the section titled “Underwriting”.

Prior to this offering, there has been no public market for our shares of common stock. We have applied to list our shares of common stock on the Nasdaq Capital Market, or Nasdaq, under the symbol “INAI.” It is a condition to the closing of this offering that our shares of common stock shall have been approved for listing on Nasdaq. No assurance can be given that our application will be approved or that trading will develop. If our application is not approved or we otherwise determine that we will not be able to secure the listing of our shares of common stock on Nasdaq, we will not complete this offering.

We are both an “emerging growth company”, as defined in the Jumpstart Our Business Startup Act of 2012, or the JOBS Act, and a “smaller reporting company” under the U.S. federal securities laws and are subject to reduced public company reporting requirements. See the section titled “Prospectus Summary — Implications of Being an Emerging Growth Company and a Smaller Reporting Company” for further information.

Investing in our common stock involves risks that are described in the “Risk Factors” section beginning on page 22 of this prospectus.

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

	Per Share of Common Stock	Total
Initial public offering price	$	$
Underwriting discount and commission(1)	$	$
Proceeds, before expenses, to us	$	$

____________

(1) Underwriting discounts and commissions do not include a non-accountable expense allowance equal to [*]% of the initial public offering price payable to the underwriters. We refer you to “Underwriting” for additional information regarding underwriters’ compensation.

We have granted a 45-day option to the representative of the underwriters to purchase up to an additional shares of common stock, solely for the purpose of covering over-allotments, if any.

The underwriters expect to deliver the shares of common stock on or about , 2025.

ThinkEquity

The date of this prospectus is , 2025

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TABLE OF CONTENTS

		Page
PROSPECTUS SUMMARY		1
THE OFFERING		17
RISK FACTORS		22
SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS		93
MARKET AND INDUSTRY DATA		95
USE OF PROCEEDS		96
DIVIDEND POLICY		99
CAPITALIZATION		100
DILUTION		103
MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS		106
BUSINESS		124
MANAGEMENT		180
EXECUTIVE COMPENSATION		187
CERTAIN RELATIONSHIPS AND RELATED PERSON TRANSACTIONS		200
PRINCIPAL STOCKHOLDERS		206
DESCRIPTION OF CAPITAL STOCK		208
SHARES ELIGIBLE FOR FUTURE SALE		214
MATERIAL U.S. FEDERAL INCOME TAX CONSEQUENCES TO NON-U.S. HOLDERS OF OUR COMMON STOCK		217
UNDERWRITING		221
LEGAL MATTERS		229
EXPERTS		229
WHERE YOU CAN FIND MORE INFORMATION		229

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ABOUT THIS PROSPECTUS

You should rely only on the information contained in this prospectus or in any related free-writing prospectus. We and the underwriters have not authorized anyone to provide any information or to make any representations other than those contained in this prospectus or in any free writing prospectus prepared by us or on our behalf or to which we have referred you. We take no responsibility for, and can provide no assurance as to the reliability of, any information that others may give you. This prospectus is an offer to sell only the shares of common stock offered hereby, but only under circumstances and in jurisdictions where it is lawful to do so. We are not making an offer to sell these shares of common stock in any jurisdiction where the offer or sale is not permitted or where the person making the offer or sale is not qualified to do so or to any person to whom it is not permitted to make such offer or sale.

Persons who come into possession of this prospectus and any applicable free writing prospectus in jurisdictions outside the United States are required to inform themselves about and to observe any restrictions as to this offering and the distribution of this prospectus and any such free writing prospectus applicable to that jurisdiction. See “Underwriting” for additional information on these restrictions.

Neither we nor the underwriters have authorized anyone to provide you with any information or to make any representations that is different from what is contained in this prospectus, any amendment or supplement to this prospectus, or in any free writing prospectuses we may authorize to be delivered or made available to you. Neither we nor the underwriters take responsibility for, and can provide no assurance as to the reliability of, any other information that others may give you. We and the underwriters are offering to sell shares of common stock, and are seeking offers to buy shares of our common stock only in jurisdictions where such offers and sales are permitted. The information contained in this prospectus or in any free writing prospectus is accurate only as of the date on the front of this prospectus or such free writing prospectus, as applicable, regardless of the time of delivery of this prospectus or such free writing prospectus, as applicable, or of any sale of our shares of common stock. Our business, financial condition, results of operations, and prospectus may have changed since the date on the front cover of this prospectus.

For investors outside of the United States: neither we nor the underwriters have done anything that would permit this offering or possession or distribution of this prospectus in any jurisdiction where action for that purpose is required, other than the United States. Persons outside of the United States who come into possession of this prospectus must inform themselves about, and observe any restrictions relating to, the offering of the shares of our common stock and the distribution of this prospectus outside of the United States.

The terms “dollar”, “U.S. dollar”, “USD” or “$” refer to United States dollars, the lawful currency of the United States of America. All references to “shares” or “shares of common stock” in this prospectus refer to our shares of our common stock, par value $0.0001 per share.

We have made rounding adjustments to some of the figures included in this prospectus.

Accordingly, numerical figures shown as totals in some tables may not be an arithmetic aggregation of the figures that preceded them.

TRADEMARKS

All trademarks, trade names and service marks appearing in this prospectus are the property of their respective owners. Solely for convenience, the trademarks and trade names in this prospectus may be referred to without the ® and ™ symbols, but such references should not be construed as any indicator that we or their respective owners will not assert, to the fullest extent under applicable law, our or their rights thereto.

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PROSPECTUS SUMMARY

The following summary highlights selected information contained elsewhere in this prospectus and is qualified in its entirety by the more detailed information and financial statements included elsewhere in this prospectus. This summary does not contain all the information that you should consider in making your investment decision. You should carefully read this entire prospectus, including the matters set forth under “Risk Factors,” “Management’s Discussion and Analysis of Financial Condition and Results of Operations,” “Special Note Regarding Forward-Looking Statements,” and our financial statements and related notes included elsewhere in this prospectus. Unless the context requires otherwise, references in this prospectus to “Invea,” the “Company,” “we,” “us,” and “our” refer to Invea Therapeutics, Inc.

Company Overview

We are a biotechnology company seeking to develop oral, small-molecule therapies for immune-mediated inflammatory diseases, or IMIDs. IMIDs are a diverse group of conditions — including skin or cutaneous inflammatory diseases such as chronic urticaria (commonly known as hives), atopic dermatitis, and prurigo nodularis; joint or rheumatologic and connective tissue disorders, such as rheumatoid arthritis and systemic lupus erythematosus; gut or gastrointestinal diseases, such as inflammatory bowel disease, including Crohn’s disease and ulcerative colitis; lung or respiratory and allergic airway conditions, such as asthma and allergic rhinitis; and autoimmune neurological diseases such as multiple sclerosis — that could result from an imbalanced or dysregulated immune response leading to chronic, multi-system or organ inflammation. Current treatments are often injectable biologics or broad immunosuppressants with safety, convenience and/or cost limitations. Our goal is to develop safe, effective, and convenient oral small molecule therapies that not only reduce inflammation, but also enhance quality of life, and potentially help achieve long-term disease remission.

We currently have two product candidates, including INVA8001, which we plan to advance into Phase 2a clinical development in the European Union, or EU, for chronic inducible urticaria, a debilitating skin condition. We intend to submit a clinical trial application, or CTA, to the competent authorities of the relevant EU member states in the second half of 2026. Subject to clearance of a CTA by the competent authorities of the relevant European Union member states, we plan to initiate a Phase 2a trial for INVA8001 in the EU shortly thereafter. It is intended that we will conduct the trial at the Fraunhofer Society for the Advancement of Applied Research e.V. c/o Charité — University Medicine Berlin, Berlin, Germany, or Fraunhofer Society for the Advancement of Applied Research. We selected the EU to leverage standardized, objective provocation testing using TempTest®, a quantitative tool used to diagnose and induce chronic inducible urticaria under controlled clinical conditions, CE (Conformité Européenne)-marked, and therefore cleared for use in the EU (but not cleared or approved by the United States Food and Drug Administration, or the U.S. FDA), which we believe will enable objective, reproducible endpoints and a higher-confidence assessment of pharmacologic effect. Following completion of a Phase 2a trial in the EU and subject to the trial achieving its clinical endpoints and regulatory clearance, for which there can be no assurance as the outcome of a Phase 2a trial is inherently uncertain, we intend to expand development of INVA8001 into chronic spontaneous urticaria (the second major form of chronic urticaria), prurigo nodularis, and atopic dermatitis as potential future indications in the United States, or U.S., EU, and globally, contingent on the process for regulatory review of marketing applications in those territories and additional future financing. Our second candidate, INVA8003, is in pre-clinical early-stage development with potential applications across multiple IMIDs. If approved by the relevant regulatory authorities, we believe these two product candidates could potentially transform the treatment of several IMIDs with unmet needs. Our current product candidates were identified using the AlphaMeld® Platform, or the AlphaMeld Platform, a technology enabled drug discovery platform described below.

Our goal is to utilize the AlphaMeld Platform, which integrates artificial intelligence, or AI, machine learning, or ML, and generative AI, or GenAI, for drug discovery, together with our team’s expertise, to identify and develop safe, effective, and convenient oral small molecule therapies. We believe that a technology-driven approach will enable us to analyze extensive biological datasets, uncover new disease connections, and identify pathways that potentially contribute to inflammation across multiple IMIDs. This belief is based on our internal research, as well as on published third-party studies that have demonstrated how advanced computational tools can expedite earlier-stage hypothesis generation. However, our approach has not yet been clinically validated, no product candidates discovered using our approach have received regulatory approval to date, and our approach has not yet generated any product revenue. The AlphaMeld Platform has not been clinically validated, and no product candidates identified using this platform by any organization have been successfully developed, approved by the U.S. FDA or

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any foreign drug regulator, or have been commercialized. Our potential future reliance on this platform as a key component of our discovery strategy to identify and nominate additional candidates to our pipeline may not result in any successful product candidate identification or development.

We are still in the early stages of applying AlphaMeld’s AI, ML, and GenAI to drug discovery and have a limited operating history. We have not yet initiated or conducted clinical trials on any product candidates, have not yet generated any product revenue, and our use of AI and associated technologies including the AlphaMeld Platform has not been clinically validated. To date, none of our product candidates identified using these technologies have been successfully developed or received regulatory approval, and we may be unsuccessful in developing or commercializing any product candidates.

We license the AlphaMeld Platform from our parent company, InveniAI LLC, or InveniAI or our Parent. See “Prospectus Summary — Our Approach — Our AI-, ML-, and GenAI-Driven Portfolio” and “Business — Our Approach — Our AI-, ML-, and GenAI-Driven Portfolio” for additional information.

Our lead product candidate, INVA8001, which was identified using the AlphaMeld Platform, is an oral, small-molecule chymase inhibitor designed to selectively target mast cell-driven inflammation, a key driver of multiple IMIDs. Mast cells play a pivotal role in allergic and inflammatory responses, and their development, survival, and proliferation are critically dependent on a particular pathway known as the SCF-c-KIT signaling pathway. Stem cell factor, or SCF, exists in two isoforms — SCF220 (a short form essential for maintaining normal blood cell production, or hematopoiesis, and tissue balance, contributing to homeostasis) and SCF248 (a long form that drives mast cell proliferation). Much like a lock (the c-KIT receptor) and key (the SCF ligand), SCF248 is located on the membrane of mast cells and is activated and released by chymase, an enzyme produced by mast cells that triggers inflammation. Once released, the soluble form of SCF248 binds to the c-KIT receptor on mast cells, initiating intracellular signaling that regulates mast cell survival and proliferation. However, in certain pathological or inflammatory settings, heightened SCF-c-KIT activity may drive excessive mast cell proliferation, accumulation and overactivation, exacerbating inflammation and tissue damage seen in IMIDs. Since the c-KIT receptor is expressed on multiple cell types, including melanocytes (pigment-producing skin cells), hematopoietic stem cells (which give rise to blood cells), germ cells (spermatogonia and ovarian follicle cells involved in reproduction), activated CD8+ T cells, certain epithelial cells, dendritic cells, eosinophils, group 2 innate lymphoid cells, interstitial cells of Cajal, and taste cells, broad c-KIT inhibition has been associated with significant safety concerns including neutropenia, hair color changes, loss of taste and skin hypopigmentation. We believe that therapeutic strategies aimed at modulating the SCF248 ligand to dampen the SCF248-c-KIT pathway could provide greater selectivity for mast cells and potentially mitigate a number of mast cell-driven diseases, offering a potentially novel, safer approach for the treatment of allergic and inflammatory conditions. Unlike c-KIT inhibitors that indiscriminately block SCF-c-KIT signaling, we believe that INVA8001 selectively targets the chymase-SCF248-c-KIT axis on mast cells, sparing SCF220-c-KIT-mediated functions necessary for normal cell homeostasis.

Chymase, the target of INVA8001, is a protease predominantly secreted by mast cells that amplifies the SCF248-c-KIT signaling pathway, in a positive feedback loop, leading to more chymase production and further enhancing mast cell survival and proliferation via activation of SCF248. By disrupting the cycle, we expect INVA8001 to dampen mast cell proliferation while maintaining critical c-KIT functions in other cell types that express the c-KIT receptor, which we believe reduces the risk of systemic side effects and provides a novel approach for the treatment of IMIDs and their related allergic and inflammatory conditions. We in-licensed INVA8001 (formerly ASB17061) from Daiichi Sankyo Company, Limited, or Daiichi Sankyo. The mechanism of action of INVA8001 has not been validated in clinical trials, but the SCF-c-KIT pathway has been shown by third parties to be relevant. We intend to submit a CTA to the competent authorities of the relevant EU member states in the second half of 2026. Subject to clearance of a CTA by the competent authorities of the relevant EU member states, we plan to initiate a Phase 2a clinical trial for INVA8001 in chronic inducible urticaria shortly thereafter. It is uncertain that submission of a CTA will result in EU regulatory authorities allowing this proposed clinical trial to begin on a timely basis, or at all. While a CTA for INVA8001 in chronic inducible urticaria has not yet been submitted, we are preparing for submission and recognize that timelines and feedback from EU regulatory authorities may evolve, including potential requests for additional nonclinical or clinical studies to support trial initiation. Following completion of a Phase 2a trial in the EU and subject to the trial achieving its clinical endpoints and regulatory clearance, for which there can be no assurance as the outcome of a Phase 2a trial is inherently uncertain, we intend to expand the development of INVA8001 into chronic spontaneous urticaria, prurigo nodularis, and atopic dermatitis as potential future indications in the U.S., EU, and globally, contingent on the process for regulatory review of marketing applications in those territories and additional future financing.

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INVA8003, our second product candidate, which was also identified using the AlphaMeld Platform, was designed and optimized for its molecular structure and therapeutic potential using AI, as a novel, oral, small-molecule inhibitor that targets a key adaptor protein known as apoptosis-associated speck-like protein containing a caspase activation and recruitment domain, or ASC, which is essential for assembling and activating inflammasomes. Inflammasomes are multiprotein complexes in immune cells that respond to tissue damage or infection by triggering inflammatory pathways and are believed to drive inflammation in several IMIDs. By inhibiting ASC, we believe that INVA8003 may disrupt these inflammasomes and potentially provide a targeted therapeutic approach for treating a range of diseases across several therapeutic areas, including metabolic disorders such as obesity, gut diseases (such as inflammatory bowel disease and pancreatitis), skin conditions (such as psoriasis and vitiligo), and lung diseases (such as asthma). In 2026, we plan to initiate investigational new drug, or IND, enabling studies, as required by the U.S. FDA, starting with an animal proof-of-concept study in an obesity model. In addition, we plan to prioritize a second indication for which an injectable biologic therapy, known as an interleukin-1β, or IL-1β, inhibitor, is already approved, which we believe may allow us to leverage established clinical insights and regulatory pathways for this common therapeutic target in inflammation, and to conduct an appropriate animal proof-of-concept study in that indication. Given the limitations of biologic therapies, a small-molecule treatment like INVA8003 could, if successfully developed and approved by regulatory authorities, offer advantages such as oral administration, potential safety benefits, ease of use, and broader patient accessibility. However, based on our internal research, while there are several therapies under investigation, no product candidate targeting inflammasomes has been successfully developed to date, and the mechanism of action of INVA8003 has not been validated in clinical trials. Our future development efforts, including planned IND-enabling and GLP toxicology studies, remain subject to significant risks and uncertainties and will require additional future financing to complete, and there can be no assurance that INVA8003 will ultimately receive regulatory approval or achieve commercial success.

The prevalence of IMIDs is significant, impacting multiple organ systems and diverse patient populations. IMIDs can be broadly categorized into cutaneous inflammatory diseases (such as chronic urticaria, atopic dermatitis, and prurigo nodularis), rheumatologic and connective tissue disorders (including rheumatoid arthritis and systemic lupus erythematosus), gastrointestinal inflammatory diseases (such as inflammatory bowel disease, including Crohn’s disease and ulcerative colitis), respiratory and allergic airway conditions (including asthma and allergic rhinitis), and autoimmune neurological diseases (such as multiple sclerosis). Based on publicly available research, we estimate that approximately 200 – 500 million individuals worldwide and approximately 64 million individuals in the U.S. are living with a commonly known IMID. We estimate that approximately 81 million individuals worldwide, approximately 1.5 million individuals in the U.S. and approximately 3.0 million individuals in the EU are living with chronic urticaria. A defining feature of many IMIDs is the dysregulation of an inflammatory response, which can progress from chronic inflammation and over time can change the way tissues are built, causing them to thicken or develop scar tissue — a process known as tissue remodeling and fibrosis. Effectively targeting and correcting this underlying immune dysregulation may present a significant opportunity to develop novel and potentially transformative treatments for IMIDs. We seek to identify key pathways and targets associated with IMIDs through the use of our parent company InveniAI’s AlphaMeld Platform that integrates AI, ML-based algorithms, GenAI, with manually curated frameworks that define and categorize relationships between biological concepts (ontologies). By using the AlphaMeld Platform to analyze the role of entities such as genes (targets), drugs, diseases, symptoms and bioprocesses, we have generated IMID-focused target-drug-disease networks to identify key entities, relationships between entities and the directionality of cause and effect to derive meaningful associations. The AlphaMeld Platform has not been clinically validated, and as yet no product candidates identified using this platform have been successfully developed, approved by the U.S. FDA or commercialized.

While many IMIDs share certain common harmful or immunopathological mechanisms, they differ in the type of immune cells involved. According to our research, treatment options for IMIDs have historically relied heavily on glucocorticoids to manage inflammation. More recently, the landscape has been dominated by injectable biologic agents — such as cytokine-blockade therapies and tumor necrosis factor (TNF) inhibitors — as well as select oral small-molecule therapies, including kinase inhibitors and immunomodulators. We believe that in general, these treatments may carry significant limitations, including safety issues (often accompanied by “black box” warnings), risk of infection, inadequate or waning response, immunogenicity, resistance with chronic use, withdrawal/rebound, compliance challenges due to inconvenient or invasive dosing regimens, and high cost — especially for biologics. Additionally, we believe that both biologics and many small molecules may also result in broad immune suppression, leaving many patients with few or ineffective options. We believe that the current landscape remains constrained by an incomplete understanding of the complex pathways driving immune dysfunction, and that there is a continued unmet need for oral, safe, and effective small-molecule therapies for IMIDs.

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Our Pipeline

We believe our product candidates have the potential to be compelling treatment options for several IMIDs. The image below demonstrates our development pipeline of IMIDs therapies and anticipated milestones.

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* All previous clinical trials of INVA8001 were conducted by Daiichi Sankyo. We have not completed any clinical trials of INVA8001 to date and have not yet obtained regulatory clearance to initiate clinical development. We intend to rely on the data collected from Daiichi Sankyo’s trials to obtain regulatory clearance to initiate clinical development in chronic urticaria. We have had no interactions with the European Medicinal Agency, or EMA, and therefore cannot be certain whether additional nonclinical or clinical studies will be required until we file and receive clearance of a CTA from the relevant EU authorities to initiate clinical development in chronic inducible urticaria. For additional information, see “— Historical Development of INVA8001 —”.

INVA8001

Our lead product candidate, INVA8001, is an oral, small-molecule, highly selective, and potent chymase inhibitor designed to target mast cell-driven inflammation in immune mediated inflammatory diseases. Mast cells, a type of immune cell, play a crucial role in epithelial function, tissue integrity, and immune responses, particularly in allergic reactions and pathogen defense. They are found in connective tissues throughout the body, including the skin, gastrointestinal tract and liver. Mast cells contain cytoplasmic granules rich in histamine, heparin, chymase, and various cytokines, which are released in response to stimuli through a process called degranulation, driving inflammation and immune-response signaling. Mast cell survival and proliferation is dependent on a signaling pathway known as the SCF-c-KIT signaling axis. SCF exists in two isoforms — SCF220 (a short form essential for maintaining normal blood cell production, or hematopoiesis, and tissue balance, contributing to homeostasis) and SCF248 (a long form that drives mast cell proliferation). Chymase, a serine protease released upon mast cell degranulation, plays a central role in this signaling pathway and in mast cell survival and proliferation. It selectively cleaves and activates membrane-bound long-form SCF248, converting it into a soluble form that subsequently binds to c-KIT, a tyrosine kinase receptor expressed on the surface of mast cells. This interaction activates SCF-c-KIT signaling, which promotes mast cell survival and proliferation, creating a positive feedback loop that perpetuates chronic inflammation in several IMIDs. We expect that INVA8001 would disrupt this pathway by inhibiting chymase, thereby preventing the activation and release of the soluble form of SCF248 and its subsequent binding to c-KIT. By selectively dampening mast cell proliferation while preserving normal c-KIT functions in other cell types, INVA8001 aims to reduce mast cell-driven inflammation while minimizing systemic side effects. Since the c-KIT receptor is expressed on multiple cell types, including melanocytes (pigment-producing skin cells), hematopoietic stem cells (which give rise to blood cells), and germ cells (spermatogonia and ovarian follicle cells involved in reproduction), among others, broad c-KIT inhibition has been associated with significant safety concerns including neutropenia, hair color changes, loss of taste and skin hypopigmentation. We believe that therapeutic strategies aimed at modulating the SCF248 ligand, rather than directly inhibiting c-KIT, could provide greater selectivity for mast cells and potentially mitigate a number of mast cell-driven diseases, offering a novel and potentially safer approach for the treatment of allergic and inflammatory conditions. Unlike broad-acting c-KIT inhibitors, which indiscriminately block both SCF isoforms, we believe INVA8001 selectively targets the chymase-SCF248-c-KIT axis on mast cells, sparing SCF220-c-KIT-mediated functions necessary for normal cell homeostasis while lowering

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inflammation and minimizing off-target effects on essential cell types. We believe this selectivity differentiates INVA8001 from traditional c-KIT inhibitors and broad-acting immune suppressants, potentially positioning it as a well-tolerated, oral small-molecule alternative for IMID treatment.

We in-licensed INVA8001 from Daiichi Sankyo in September 2021. INVA8001 has undergone preclinical and clinical testing for use in the treatment of atopic dermatitis, and has demonstrated a well characterized pharmacokinetic, or PK, profile and was well-tolerated in a single ascending dose, or SAD, trial, a multiple ascending dose, or MAD, trial, and a Phase 2 clinical trial conducted by Daiichi Sankyo. All previous clinical trials of INVA8001 were conducted by Daiichi Sankyo in the United States, and we have not initiated any clinical trials for INVA8001 to date. While Daiichi Sankyo’s Phase 2 trial in atopic dermatitis did not meet the primary efficacy endpoints, we have closely analyzed the Phase 2 trial data, the proposed mechanism of action, and its relevance, and we believe that we have identified potential gaps in INVA8001’s trial design. INVA8001 may fail to meet all endpoints in our planned clinical trials, as well, despite changes in the clinical trial design, dose and dosing regimen.

Preclinically, Daiichi Sankyo evaluated the efficacy of INVA8001 in attenuating chymase-mediated cleavage of both recombinant murine and human SCF165. In this proof-of mechanism study, INVA8001 was tested at varying concentrations and INVA8001 dose dependently inhibited the chymase-mediated cleavage of both murine and human SCF, preventing the formation of active c-KIT ligand (the soluble form of SCF). To further support our development strategy, we conducted two additional proof-of-mechanism studies: an in vitro human donor mast cell assay, evaluating INVA8001’s effect on mast-cell activation and degranulation and an in vivo study using an Mdr2 knockout mouse model with elevated mast cells in the liver.

In the in vitro human mast cell assay conducted at the Fraunhofer Society for the Advancement of Applied Research, freshly isolated primary human skin mast cells from a breast tissue sample were passively sensitized with IgE (immunoglobulin E, a type of antibody) and stimulated with anti-IgE to trigger activation and degranulation. INVA8001’s effects were assessed using clinically recognized readouts — chymase activity, percent CD63+ surface expression (mast-cell activation), and tryptase concentration — and benchmarked against two reference agents (comparators): chymostatin (a non-specific chymase inhibitor; tool compound) and a commercially available anti-c-KIT antibody (mechanism control). Assay controls included a negative control (IgE-sensitized, unstimulated cells) and a positive control (IgE-sensitized, anti-IgE, stimulated cells). INVA8001 resulted in approximately 100% inhibition of chymase activity, an approximately 82% reduction in mast-cell activation (CD63+ cells), and an approximately 95% reduction in tryptase concentration (pg/mL). By comparison, chymostatin resulted in an approximately 71% reduction in chymase activity, no change in mast-cell activation (CD63+ cells), and an approximately 24% reduction in tryptase concentration (pg/mL). The anti-c-KIT antibody produced no meaningful changes in these endpoints.

In the in vivo study, conducted at Indiana University (Bloomington, Indiana), we used an Mdr2 knockout mouse model, which exhibits elevated hepatic mast-cell accumulation, to evaluate the effect of chronic dosing of INVA8001 on mast-cell proliferation and its markers. INVA8001 was administered intraperitoneally at 10 mg/kg or 20 mg/kg for two weeks. Treatment with INVA8001 reduced hepatic mRNA expression of the high-affinity IgE receptor, or FcεRI, and mucosal mast-cell protease-1, or Mcpt1, at both doses. Histological assessment also showed substantial accumulation of tryptase, or Tpsb2 – positive cells in model controls using immuno-histochemistry, whereas INVA8001 at 20 mg/kg resulted in an approximately 72% reduction in tryptase-positive mast cells.

We intend to submit a CTA to the competent authorities of the relevant EU member states in the second half of 2026. Subject to clearance of a CTA, for which there is no assurance, by the competent authorities of the relevant EU member states, we plan to initiate a Phase 2a trial for INVA8001 in the EU shortly thereafter. We selected the EU to leverage standardized, objective provocation testing using TempTest®, a quantitative tool used to diagnose and induce chronic inducible urticaria under controlled clinical conditions, CE (Conformité Européenne)-marked, and therefore cleared for use in the EU (but not cleared or approved by the U.S. FDA), enabling objective, reproducible endpoints and a higher-confidence assessment of pharmacologic effect. Following completion of a Phase 2a trial in the EU and subject to the trial achieving its clinical endpoints and regulatory clearance, for which there can be no assurance as the outcome of a Phase 2a trial is inherently uncertain, we intend to expand development of INVA8001 into chronic spontaneous urticaria, prurigo nodularis, and atopic dermatitis as potential future indications in the U.S., EU, and globally, contingent on the process for regulatory review of marketing applications in those territories and additional future financing. This development strategy aligns with other third-party companies conducting similar studies in

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chronic inducible urticaria. It is intended that the study will be conducted at the Fraunhofer Society for the Advancement of Applied Research to evaluate patients over 12 weeks with a placebo and two active treatment arms at 50 mg twice daily, or BID, and 75 mg BID. The trial will assess biomarkers, including chymase, tryptase, and SCF levels, as well as mast cell count, and will evaluate efficacy response through provocative testing outcomes (partial, complete, or no response), pruritus patient-reported outcomes, or PRO, pharmacokinetics, and safety. We believe that these assessments will allow us to demonstrate safety and efficacy to validate INVA8001’s therapeutic potential in mast cell-driven IMIDs. While a CTA has not yet been submitted, we are preparing for submission and recognize that timelines and feedback from EU regulatory authorities may evolve, including potential requests for additional nonclinical or clinical information to support trial initiation. Therefore, it is uncertain that submission of a CTA will result in EU regulatory authorities allowing clinical trials to begin on a timely basis, or at all. We believe that INVA8001 potentially offers an oral, small-molecule potentially safer alternative with a convenient dosing regimen compared to current standard-of-care treatments.

Current Treatment Options and Limitations

Current chronic urticaria treatment guidelines recommend that first-line treatment should be managed with second-generation antihistamines to provide hive and itch symptom control and the avoidance of triggers (e.g., cold, food additives, stress, infections, etc.). For those patients whose symptoms remain uncontrolled following first-line therapy, second-line treatment includes one or more of the following: elevated doses of second-generation antihistamines, the addition of another second-generation antihistamine, an H2 antagonist that blocks the action of histamine at the histamine H₂ receptors, a leukotriene receptor antagonist (anti-inflammatory drugs) and a first-generation antihistamine. Based on published studies, approximately 50% of patients achieve effective symptom relief with standard-dose antihistamines. Those whose chronic urticaria remains uncontrolled following the second-line therapy can advance to additional treatments, which can include injectable biologics, such as omalizumab and dupilumab, and oral agents such as remibrutinib, and cyclosporin or other anti-inflammatory or immunosuppressant agents. For refractory patients, response rates remain limited, with omalizumab having a widely varying complete response rate that may be as low as 26%. As a result, we believe that there remains an unmet medical need for an oral, long-term safe and effective treatment for chronic urticaria.

INVA8003

Our second product candidate, INVA8003, was designed and optimized for its molecular structure and therapeutic potential using AI, as a novel, oral, small-molecule inhibitor of ASC, a critical adaptor protein that facilitates the assembly and activation of various inflammasomes which are key mediators that drive inflammatory responses and cell death. Dysregulated inflammasome activation has been implicated in chronic inflammatory diseases, making inflammasome inhibition a promising therapeutic approach for IMIDs. There are several types of inflammasomes, including NOD-like receptors, or NLRs, comprising of inflammasomes such as NLRP1, NLRP3, NLRP6, NLRP7, NLRP12, and NLRC4, as well as AIM2-like receptors, or ALRs, and the pyrin inflammasome. By inhibiting ASC, INVA8003 aims to modulate inflammasome-driven inflammation, offering a targeted approach that we believe has the potential to address the underlying immunopathology of chronic inflammation across several IMIDs. Prior efforts to develop NLR inflammasome inhibitors, have predominantly focused on NLRP3 and its ATP-binding regions that are also common across different proteins involved in normal human physiological functions, raising potential concerns about tolerability and off-target effects. Instead, our approach targets protein-protein interactions, which we believe may offer a better-tolerated alternative. Additionally, therapies targeting NLRP3 alone may have limited therapeutic efficacy and may be insufficient to fully inhibit the inflammatory response in IMIDs. INVA8003 is designed to potentially provide a broader therapeutic window

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by targeting ASC, a common adaptor protein that is involved in the activation of multiple inflammasomes beyond NLRP3. By inhibiting ASC, we believe that INVA8003 has the potential for broad applicability, and we have identified several IMIDs that we believe could benefit from this more targeted approach.

Potential indications under consideration for INVA8003

In 2026, we plan to initiate IND-enabling studies, as required by the U.S. FDA, starting with an animal proof-of-concept study in an obesity model. In addition, we plan to prioritize a second indication for which an injectable biologic IL-1β, inhibitor, is already approved, which we believe may allow us to leverage established clinical insights and regulatory pathways for this common therapeutic target in inflammation, and to conduct an appropriate animal proof-of-concept study in that indication. Given the limitations of biologics, a small-molecule inhibitor in the indication we identify could potentially offer advantages such as safety, ease of administration, and broader patient accessibility. Based on our knowledge, no other product candidate specifically designed to target inflammasome activation has been approved for commercial use to date, and the INVA8003 mechanism of action has not been validated.

While INVA8003 was designed and optimized for its molecular structure and therapeutic potential using AI as a targeted approach to inhibit the ASC dimerization process and protein-protein interaction specific to inflammasome assembly and believe it may offer a potentially better tolerated approach by avoiding binding pockets that are common across different proteins involved in normal human physiological functions, which were the target of prior attempts at designing NLRP3 inflammasome inhibitors, we will need to conduct lengthy and expensive preclinical studies and eventually clinical trials on INVA8003 and there can be no guarantee that we will achieve the results we anticipate.

Intellectual Property

We hold development and commercialization rights to our pipeline and product candidates. Our product candidates are protected through exclusive intellectual property rights, including filed and issued patents covering composition of matter, dose, dosing regimen, methods of treatment, and formulation. We have rights to a total of sixteen patent applications and patents. We exclusively licensed five issued patents for INVA8001 from Daiichi Sankyo. We also own eleven pending patent applications, including one U.S. pending provisional patent application, one pending international Patent Cooperation Treaty, or PCT, application, and nine pending non-provisional applications in the U.S. and certain foreign jurisdictions pertaining to both INVA8001 and INVA8003. The in-licensed granted U.S. patent covering INVA8001 is expected to expire in 2030, though we may be eligible for a patent term extension of up to five years. Additionally, we have in-licensed patents in Japan and countries within the European Patent Convention (Germany, France, and Great Britain), all of which have comparable expirations in 2030 without extensions of patent terms. Patent applications covering methods of using INVA8001 have also been filed and are currently pending in Canada, the EU, Japan, and the U.S, with potential patents, if granted, expected to expire in 2043. In addition, a PCT application covering certain dosing regimens, formulations, and methods of use for INVA8001 has been filed and is currently pending, with potential patents, if granted, expected to expire in 2045. Finally, patent applications covering the composition of INVA8003 have been filed and are currently pending

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in Canada, China, the EU, Japan, and the U.S., with potential patents, if granted, expected to expire in 2043 without patent term extension. A provisional application relating to INVA8003 was recently filed in 2025, with potential patents, if granted, expected to expire in 2046 without patent term extension.

Our Approach

Immune-Mediated Inflammatory Diseases

Immune-mediated inflammatory diseases encompass a diverse group of conditions characterized by dysregulated immune responses that lead to chronic, multi-system, and organ inflammation. These diseases impose a significant global healthcare burden, affecting millions of patients across multiple organ systems and diverse populations. IMIDs are often chronic, requiring long-term treatment strategies that can be both costly and complex, underscoring the need for novel, more effective, and accessible therapeutic options. IMIDs can be broadly categorized into several key areas:

Cutaneous inflammatory diseases (such as chronic urticaria, atopic dermatitis, and prurigo nodularis), which may significantly impact quality of life due to persistent skin inflammation and severe itching.

Rheumatologic and connective tissue disorders (including rheumatoid arthritis and systemic lupus erythematosus), which may cause progressive joint and systemic damage, potentially leading to disability and increased healthcare costs.

Gastrointestinal inflammatory diseases (including eosinophilic gastrointestinal diseases such as eosinophilic esophagitis, eosinophilic gastritis, inflammatory bowel disease, including Crohn’s disease, and ulcerative colitis), which may result in chronic gastrointestinal inflammation and complications potentially requiring surgical intervention in severe cases.

Respiratory and allergic airway conditions (such as asthma and allergic rhinitis), which may involve persistent airway inflammation potentially leading to significant morbidity and healthcare utilization.

Autoimmune neurological diseases (such as multiple sclerosis), where chronic inflammation and immune-mediated demyelination may result in progressive neurological dysfunction.

Based on publicly available research on the estimated population affected by each of these commonly known IMIDs, we estimate approximately 200 – 500 million individuals worldwide and approximately 64 million individuals in the U.S. are living with a commonly known IMID. Furthermore, those already affected by an IMID face an increased risk of developing another IMID. As the global population continues to age, the prevalence of IMIDs is projected to rise further. Treatment options for IMIDs have historically relied heavily on glucocorticoids to

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manage inflammation and are not an option for long-term treatment due to adverse events, limited efficacy and poor compliance. More recent advances, have led to the development of immune-targeted therapeutics, such as biological agents (cytokine blockade therapies and tumor necrosis factor, or TNF, inhibitors) and small molecule-based therapies (kinase inhibitors and immunomodulators). While small molecules and biologics which are currently used for the treatment of various IMIDs have significantly advanced the management of these conditions, they also have significant disadvantages, including:

• Safety Issues. Oral treatments include black box warnings such as increase in malignancy, adverse cardiovascular events, blood clots and serious infections. Biologics have known side effects such as lymphoma, serious infections, neutropenia, hair color changes, loss of taste, and hypopigmentation.

• Inadequate Response. Patients may see partial or no response. Patients may also develop resistance caused by long-term use.

• Immunogenicity. Biologic treatments may generate anti-drug-antibodies, which could counteract the therapeutic effects of the treatment, lead to resistance and, in rare cases, induce adverse reactions.

• Withdrawal/Rebound. Long term continuous or inappropriate use of topical treatments can result in the development of rebound flares after stopping treatment, such as erythematoedematous and papulopustular.

• Compliance. Inconvenient or invasive dosing regimens seen with the strict and often tedious application regimens of topical treatments and a commitment to a biweekly protocol for injectable administration of biologics often result in poor patient compliance.

• High Cost. Long term treatment requirements for the majority of IMIDs, especially biologics, resulting in a high healthcare burden.

We believe that there continues to be an unmet need for oral, safe and effective small molecule therapies for the treatment of IMIDs.

Our AI-, ML-, and GenAI-Driven Portfolio

We aim to develop oral, safe and effective small molecule therapies that target common IMID pathways involved in the initiation and progression of an inflammatory response, from inflammasome activation to matrix remodeling and fibrosis. The inflammatory process has several components, including inflammatory inducers, sensors, mediators and the tissues that are ultimately affected. Each component follows multiple pathways activated by specific stimuli, such as pathogens or allergens. Targeting and correcting a dysregulated inflammatory response to effectively address IMIDs may present a significant opportunity to develop novel and potentially transformative treatments. We believe that the lack of an in-depth understanding of the immune-pathophysiological mechanisms underlying immune-mediated inflammation has restricted therapeutic options for several IMIDs to merely symptomatic interventions, with limited effectiveness.

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We seek to leverage our expertise together with the AlphaMeld Platform’s AI-, ML-, and GenAI-tools to deconvolute complex biological information and extrapolate potentially significant relationships between a disease, gene (target) and best-fit therapeutic option, to select and validate product candidates.

Our analyses consist of the following steps:

• AI-, ML-and GenAI-Based Association Building. Through our use of our parent company InveniAI’s AlphaMeld Platform that integrates AI, ML-based algorithms and GenAI, with manually curated frameworks that define and categorize relationships between biological concepts (ontologies), we seek to identify key pathways and targets associated with IMIDs. By using the AlphaMeld Platform to analyze the role of key entities such as genes (targets), drugs, diseases, symptoms and bioprocesses, we have generated IMID-focused target-drug-disease networks to identify key entities, relationships between entities and the directionality of cause and effect to derive meaningful associations. Using this approach, and pursuant to our Shared Services Agreement described below, InveniAI delivered to us, an association network of several thousand potential targets to thousands of drugs and hundreds of IMIDs, which we refer to as our target association network. The target association network was developed using the AI, ML, and GenAI technology of the AlphaMeld Platform and publicly available third-party data sets. We believe the AlphaMeld Platform’s AI-, ML-, and GenAI-driven approach has the potential to accelerate the discovery process as well as identify “hidden” connections that may be very difficult to discern with human oversight alone. Furthermore, this approach provides our translational scientists with evidence to support novel discoveries and potentially helps streamline the regulatory pathway of future product candidates. This belief is based on our internal research, as well as on published third-party studies that have demonstrated how advanced computational tools can expedite earlier-stage hypothesis generation. However, our approach has not yet been clinically validated, and no product candidates discovered using our approach have received regulatory approval to date. The AlphaMeld Platform has not been clinically validated, and as yet no product candidates identified using this platform have been successfully developed, approved by the U.S. FDA or any foreign regulator or commercialized. Our potential reliance on this platform as a key component of our discovery strategy may not result in successful product candidate identification or development.

On October 1, 2023, we entered into a license agreement with InveniAI, or the AlphaMeld License, which was amended effective January 1, 2024 and further amended effective September 1, 2025. Under the AlphaMeld License, we have non-exclusive rights to access and use InveniAI’s AlphaMeld Platform for our internal business purposes in the field of immune-mediated inflammatory diseases for a period of three years from January 1, 2024, unless earlier terminated in accordance with its terms, and with automatic renewals for additional one-year periods, unless terminated by either party with prior written notice. The September 1, 2025 amendment to the AlphaMeld License reduced the annual subscription fee to $50,000 per annual subscription term effective January 1, 2024, payable following the successful completion of our initial public offering, at which time we will remit the total accrued fees of $0.1 million as of September 30, 2025, in accordance with mutually agreed payment timing. The AlphaMeld License, as amended, clarifies intellectual property ownership whereby we retain all rights to any inventions, data, know-how, or other intellectual property generated by us through use

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of the AlphaMeld Platform by our scientists, and AlphaMeld Corporation, a wholly owned subsidiary of InveniAI, will execute assignments to effect the transfer of such rights to us upon request without additional consideration. In addition, the September 1, 2025 amendment to the AlphaMeld License assigns all obligations of InveniAI under the agreement to AlphaMeld Corporation, a wholly owned subsidiary of InveniAI. AlphaMeld Corporation owns all intellectual property rights and assets necessary for the operation and commercialization of the AlphaMeld Platform. AlphaMeld Corporation consented to such assignment and agreed to assume all obligations of InveniAI under the agreement. The AlphaMeld License gives us the right to access and use the AlphaMeld Platform to monitor our target association network to identify future product candidates. For more information see “Certain Relationships and Related Person Transactions — Shared Services Agreement with InveniAI” and “Business — Licensing and Collaboration Agreements — InveniAI, LLC –– Use of Proceeds.”

• Prioritization of Product Concepts with Domain Expert Oversight. AI-, ML-, and GenAI-derived associations are rank-ordered by domain experts based on the strength, quality and volume of evidence, as well as clinical relevance, competitive landscape, unmet need, regulatory path and commercial attractiveness. Based on our analysis, we have prioritized two areas that provide evidence of a strong association with disease pathogenesis of several IMIDs: mast cell and inflammasome biology.

• Product Concept Validation and Product Candidate Selection. We have designed our process to help us validate concepts, for which we can identify and in-license relevant product candidates (e.g., INVA8001) or design novel product candidates (e.g., INVA8003).

Our Team

We have a management team that includes individuals who have held senior roles at leading pharmaceutical or biotechnology organizations with extensive collective experience across the drug discovery and development continuum, including research, translational medicine, clinical development, regulatory affairs and policy, patient advocacy and business and corporate development. We intend to leverage our combined expertise in drug discovery and development and AI- and ML-tools to continue building our pipeline of what we believe are promising small molecule oral product candidates for the treatment of IMIDs with unmet needs. Certain of our officers and directors, including Krishnan Nandabalan, Ph.D., Demetrios Kydonieus, J.D., M.B.A. and Jonathan Zalevsky, Ph.D., are also serving as employees, officers and/or directors of InveniAI, our parent company and our largest stockholder, as well as of its wholly owned subsidiary, AlphaMeld Corporation. Krishnan Nandabalan, our Chief Executive Officer, or CEO, and Chairman of the Board, is expected to remain as President, Director and CEO of both InveniAI and its wholly owned subsidiary, AlphaMeld Corporation. Following the completion of our initial public offering, we expect Dr. Nandabalan to spend a minimum of 40 hours a week on the business affairs and operations of Invea. Since May 2025, and as of September 30, 2025, Dr. Okada, our Chief Medical Officer, and Dr. Alesci, our Chief Scientific Officer, are working limited hours at reduced pay due to funding limitations and the need to reduce salary expenses.

For more information see “Risk Factors — Risks Related to Our Relationship with InveniAI — Certain of our directors and officers are currently allocating a portion of their time to InveniAI, where they serve as directors or are employees, which reduces allocation of their time to managing our business and affairs” and “— The management of and beneficial ownership in InveniAI by our executive officers and our directors creates the appearance of conflicts of interest, and may create actual conflicts of interest.”

Our Strategy

Our mission is to transform the lives of patients with chronic IMIDs through the development of oral, safe and effective small molecule product candidates. The key elements of our strategy include:

• Maximize the value of our lead product candidate, INVA8001. We plan to submit a CTA in the second half of 2026 and, subject to regulatory clearance by the competent authorities of the relevant EU member states, we plan to initiate a Phase 2a trial for INVA8001 in chronic inducible urticaria in the EU shortly thereafter. Following completion of a Phase 2a trial in the EU and subject to the trial achieving its clinical endpoints and regulatory clearance, for which there can be no assurance as the outcome of a Phase 2a trial is inherently uncertain, we intend to expand the development of INVA8001 into chronic spontaneous urticaria, prurigo nodularis, and atopic dermatitis as potential future indications in the U.S., EU, and

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globally, contingent on the process for regulatory review of marketing applications in those territories and additional future financing. There can be no assurance, however, that we will obtain the required regulatory clearances, achieve the requisite clinical endpoints, or secure the necessary financing.

• Advance INVA8003 into IND-enabling studies for the treatment of select IMIDs, subject to additional future financing. INVA8003 was designed and optimized for its molecular structure and therapeutic potential using AI, as a novel, oral, small-molecule inhibitor of ASC and its interaction with other components of the inflammasome. We believe that INVA8003, if approved by regulatory authorities, has the potential to have broad applicability across several IMIDs. In 2026, we plan to initiate IND-enabling studies starting with an animal proof-of-concept study in an obesity model. In addition, we plan to prioritize a second indication for which an injectable IL-1β inhibitor is already approved, which we believe may allow us to leverage established clinical insights and regulatory pathways for this common therapeutic target in inflammation, and to conduct an appropriate animal proof-of-concept study in that indication. Given the limitations of biologics, a small-molecule inhibitor in the indications we identify could offer advantages such as safety, ease of administration, and broader patient accessibility. Our future development efforts, including planned IND-enabling and GLP toxicology studies, remain subject to significant risks and uncertainties and will require additional future financing to complete, and there can be no assurance that INVA8003 will ultimately receive regulatory approval or achieve commercial success.

• Continue to identify select IMIDs and nominate additional product candidates for their treatment. We intend to use the AlphaMeld Platform to explore our IMID association network, encompassing several thousand potential targets, to select additional small molecule product candidates, which we can subsequently either in-license or design using AI, for IMIDs where there is a clinically defined unmet need and regulatory pathway for effective oral therapies.

• Selectively enter into strategic collaborations. We plan to enter into strategic collaborations relating to product candidates that we believe have promising utility in disease areas or by patient populations that are better served by the resources of larger biopharmaceutical companies. We may also enter into collaborations for third-party product candidates for which we believe our technologies and expertise may be valuable. No such collaborations have yet been entered into.

Summary Risk Factors

Our business is subject to numerous risks that you should be aware of before making an investment decision. These risks are described more fully in the section titled “Risk Factors” and include, among others:

• We have incurred significant operating losses since inception and anticipate that we will continue to incur significant operating losses for the foreseeable future and may never achieve or maintain profitability. Our independent registered public accounting firm included in its audit opinion for the year ended December 31, 2024 an explanatory paragraph that there is substantial doubt as to our ability to continue as a going concern. Our recurring losses from operations could continue to raise substantial doubt regarding our ability to continue as a going concern.

• We have a limited operating history and have never generated product revenues, which may make it difficult to evaluate the success of our business to date and to assess our future viability.

• Even if this offering is successful, we will need substantial additional funding, and if we are unable to raise capital when needed, we could be forced to delay, reduce, or eliminate our product development programs or commercialization efforts.

• Our approach to the discovery and development of product candidates based on the AlphaMeld Platform is unproven, and we do not know whether we will be able to develop any products of commercial value, or if competing technological approaches will limit the commercial value of our product candidates or render our platform obsolete.

• We are currently substantially dependent on the success of INVA8001, which is our lead product candidate. If we are unable to advance INVA8001 in clinical development, obtain CTA approval and ultimately commercialize INVA8001, or if we experience significant delays in doing so, our business will be materially harmed.

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• The success of INVA8001, INVA8003 or any future product candidates, will depend significantly on coverage and adequate reimbursement or the willingness of patients to pay for these products.

• We were not involved in the early development of INVA8001; therefore, we are dependent on third parties having accurately generated, collected, interpreted and reported data from certain preclinical and clinical trials for INVA8001, which were conducted between 2011 and 2014. We may fail to demonstrate effectiveness of INVA8001 despite a different clinical trial design, and we may observe safety concerns with INVA8001 that have not been observed to date.

• We are very early in our development efforts. If we are unable to successfully develop, receive regulatory approval for and commercialize our product candidates for our planned or any other indications, or successfully develop any other product candidates, or experience significant delays in doing so, our business will be substantially harmed.

• The regulatory approval processes of the U.S. FDA, European Commission, which is the authorizing body for all centrally authorized medicinal products in the EU, which makes binding decisions based on the recommendations of the European Medicinal Agency, or EMA, the UK Medicines and Healthcare Products Regulatory Agency, or MHRA, and comparable foreign authorities are lengthy, time consuming, expensive and inherently unpredictable. If we are not able to obtain the required regulatory clearances for clinical trials and approval of our product candidates, our business will be substantially harmed.

• We have not yet initiated or completed testing of any product candidate in clinical trials. Success in preclinical studies or earlier clinical trials may not be indicative of results in future clinical trials.

• If we are unable to establish sales, marketing and distribution capabilities for INVA8001, INVA8003 or any other product candidate that may receive regulatory approval, we may not be successful in commercializing those product candidates if and when they are approved.

• Even if any of our product candidates receive marketing approval, they may fail to achieve the degree of market acceptance by physicians, patients, third-party payors and others in the medical community necessary for commercial success.

• We will be reliant on a non-exclusive license from InveniAI to use InveniAI’s AlphaMeld Platform to monitor our target association network and increase our pipeline of product candidates. The AlphaMeld Platform may be licensed to our competitors. If this license is terminated, this could delay, prevent or impair our discovery and development of future product candidates.

• We may not be successful in our efforts to increase our pipeline of product candidates by pursuing additional indications for our current product candidates or by in-licensing or acquiring additional product candidates for other diseases or by designing our own product candidates.

• We face substantial competition, which may result in a smaller than expected commercial opportunity and/or others discovering, developing or commercializing products before or more successfully than we do.

• We heavily rely on the exclusive license from Daiichi Sankyo to provide us with intellectual property rights to develop and commercialize INVA8001. If this license is terminated, we would lose our rights to develop and commercialize INVA8001.

• We intend to rely on third parties to conduct a significant portion of our planned clinical trials and potential future clinical trials for product candidates, and those third parties may not perform satisfactorily, including failing to meet deadlines for the completion of such trials.

• We contract with third parties for the manufacture of INVA8001 and INVA8003 for clinical drug supply and expect to continue to do so for commercialization if approved by the relevant regulatory authorities. This reliance on third parties increases the risk that we will not have sufficient quantities of our product candidates or such quantities at an acceptable cost or quality, which could delay, prevent or impair our development or commercialization efforts.

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• The manufacture of our product candidates is complex and difficulties may be encountered in production.

• Our preclinical studies and clinical trials may fail to demonstrate the safety and efficacy of our product candidates, or serious adverse or unacceptable side effects may be identified during the development of our product candidates, which could prevent or delay regulatory approval and commercialization, increase our costs or necessitate the abandonment or limitation of the development of some of our product candidates.

• Certain of our directors and our CEO are currently allocating a portion of their time to InveniAI or its subsidiaries, where they serve as employees, officers or directors, which reduces allocation of their time to managing our business and affairs and creates potential conflicts of interest.

• Stockholder litigation could have a material adverse effect on our business, operating results and financial condition.

• The concentration of ownership of our common stock among our current parent company and existing executive officers, directors and principal stockholders may prevent new investors from influencing significant corporate decisions.

• If we are unable to obtain or protect intellectual property rights or expand the term of our patents, including our patent covering the lead compound underlying INVA8001, which, absent a patent term extension is due to expire in 2030, related to any of our product candidates, we may not be able to compete effectively in our market.

Corporate Information

We were incorporated under the laws of the state of Delaware on October 20, 2021, under the name Invea Therapeutics, Inc. Prior to this offering we were a controlled subsidiary of InveniAI. We expect that InveniAI may remain a significant shareholder following this offering, owning up to % of our outstanding shares of common stock, depending on the number of shares we sell in this offering. InveniAI is a technology company that uses AI and ML to drive innovation across drug discovery and development and is a controlled subsidiary of BioXcel LLC. Our principal executive offices are located at 2614 Boston Post Road Suite 33B, Guilford CT 06437, USA, and our telephone number is +1.203.643.8002. Our website address is https://www.inveatx.com. The information contained on, or that can be accessed through, our website is not incorporated by reference into this prospectus, and you should not consider any such information to be a part of this prospectus. We have included our website address in this prospectus solely as an inactive textual reference.

Certain Unaudited Financial Results

We estimate that our cash was approximately million as of , 2025. This estimate of our cash is unaudited and has been prepared by and is the responsibility of management. This estimate is based on currently available information and does not present all necessary information for an understanding of our financial condition as of , 2025. Our independent registered public accounting firm has not conducted a review of and does not express an opinion or any other form of assurance with respect to this estimate. Accordingly, undue reliance should not be placed on this estimate. The estimate is not necessarily indicative of any future period and should be read in conjunction with our consolidated and combined financial statements and the related notes and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” included elsewhere in this prospectus.

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

Emerging Growth Company

As a company with less than $1.235 billion in revenue during our last fiscal year, we qualify as an “emerging growth company” as defined in the JOBS Act. For so long as we remain an emerging growth company, we may take advantage of relief from certain reporting requirements and other burdens that are otherwise applicable generally to public companies. In particular, these provisions include:

• reduced obligations with respect to financial data, including only being required to present two years of audited financial statements, in addition to any required unaudited interim financial statements, and only two years of related “Management’s Discussion and Analysis of Financial Condition and Results of Operations” disclosure in our initial registration statement;

• an exception from compliance with the auditor attestation requirements of Section 404 of the Sarbanes-Oxley Act of 2002, as amended, or the Sarbanes-Oxley Act, on the effectiveness of our internal control over financial reporting;

• reduced disclosure about our executive compensation arrangements in our periodic reports, proxy statements and registration statements;

• exemptions from the requirements of holding non-binding advisory votes on executive compensation or golden parachute arrangements; and

• an exemption from compliance with the requirements of the Public Company Accounting Oversight Board regarding mandatory audit firm rotation and the communication of critical audit matters in the auditor’s report on financial statements.

We may take advantage of these provisions until the last day of the fiscal year ending after the fifth anniversary of this offering or such earlier time that we no longer qualify as an emerging growth company. We will cease to qualify as an emerging growth company on the date that is the earliest of: (i) the last day of our fiscal year following the fifth anniversary of the date of the completion of this offering, (ii) the last day of the fiscal year in which we have more than $1.235 billion in total annual gross revenues, (iii) the date on which we are deemed to be a “large accelerated filer,” as defined under the Securities and Exchange Act of 1934, as amended, or the Exchange Act, which means 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, or (iv) the date on which we have issued more than $1.0 billion of non-convertible debt over the prior three-year period. We may choose to take advantage of some, but not all, of the available exemptions, and therefore, the information that we may provide holders of our shares of common stock may be different than the information you might receive from other public companies in which you hold equity.

We have elected to take advantage of certain reduced reporting requirements in this prospectus and may elect to take advantage of other reduced reporting requirements in future filings. In particular, in this prospectus, we have provided only two years of audited financial statements and have not included all of the executive compensation related information that would be required if we were not an emerging growth company. Accordingly, the information contained herein may be different than you might obtain from other public companies in which you hold equity interests.

In addition, under the JOBS Act, emerging growth companies can delay adopting new or revised accounting standards until such time as those standards apply to private companies. We have elected to take advantage of this extended transition period to enable us to comply with new or revised accounting standards that have different effective dates for public and private companies until the earlier of the date we (i) are no longer an emerging growth company or (ii) affirmatively and irrevocably opt out of the extended transition period provided in the JOBS Act. As a result of the accounting standards election, we will not be subject to the same implementation timing for new or revised accounting standards as other public companies that are not emerging growth companies, which may make comparison of our financials to those of other public companies more difficult. As a result of these elections, the information that we provide in this prospectus may be different than the information you may receive from other

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public companies in which you hold equity interests. In addition, it is possible that some investors will find our common stock less attractive as a result of these elections, which may result in a less active trading market for our common stock and higher volatility in our share price.

Smaller Reporting Company

We are also a “smaller reporting company,” meaning that the market value of our shares held by non-affiliates plus the proposed aggregate amount of gross proceeds to us as a result of this offering is less than $700 million and our annual revenue was less than $100 million during the most recently completed fiscal year. We may continue to be a smaller reporting company after this offering if either (i) the market value of our shares held by non-affiliates is less than $250 million or (ii) our annual revenue was less than $100 million during the most recently completed fiscal year and the market value of our shares held by non-affiliates is less than $700 million. If we are a smaller reporting company at the time we cease to be an emerging growth company, we may continue to rely on exemptions from certain disclosure requirements that are available to smaller reporting companies. Specifically, as a smaller reporting company we may choose to present only the two most recent fiscal years of audited financial statements in our Annual Report on Form 10-K and, similar to emerging growth companies, smaller reporting companies have reduced disclosure obligations regarding executive compensation. We may continue to be a smaller reporting company until the fiscal year following the determination that we no longer meet the requirements necessary to be considered a smaller reporting company.

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THE OFFERING

Common stock offered by us		shares of common stock (which includes the reserved share program described herein).
Assumed initial public offering price		We estimate that the price per share of common stock will be $ , which is the midpoint of the price range set forth on the cover page of this prospectus.
Over-allotment option		We have granted the underwriters an option for a period of 45 days to purchase from us up to an additional shares of common stock (equal to 15.0% of the total number of shares sold in this offering) at the public offering price per share, to cover over-allotments, if any.
Representative’s Warrants		Upon the closing of this initial public offering, we have agreed to issue to the Representative (or its designated assignees) warrants to purchase a number of our common stock equal to an aggregate of up to shares based on the assumed public offering price (representing 5.0% of the total number of shares of common stock sold in this initial public offering, including any shares of common stock sold upon exercise of the Representative’s over-allotment option), or the Representative’s Warrants. The Representative’s Warrants will have an exercise price equal to $ (representing 125.0% of the initial public offering price of the shares of common stock sold in this initial public offering and may be exercised on a cashless basis if not covered by an effective registration statement. The Representative’s Warrants will not be exercisable for one hundred and eighty (180) days from the commencement of sales in this offering, and will expire four and one-half (4.5) years after the commencement of such sales. For additional information regarding our arrangement with the Representative, please see “Underwriting.”
Common stock to be outstanding immediately after this offering		shares of common stock ( shares of common stock if the underwriters exercise in full their over-allotment option to purchase additional shares of common stock).
Use of proceeds		We estimate that the net proceeds to us from this offering will be approximately $ million (or approximately $ million if the underwriters exercise in full their over-allotment option to purchase additional shares), assuming an initial public offering price of $ per share, which is the midpoint of the price range set forth on the cover page of this prospectus, after deducting the estimated underwriting discounts and commissions and estimated offering expenses payable by us.
		We currently intend to use the net proceeds from this offering, together with our existing cash as follows: (i) approximately $ million to advance the development of INVA8001, including the initiation of a Phase 2a trial and the expected data readout for chronic inducible urticaria, subject to CTA filing and clearance; (ii) approximately $ million to advance the pre-clinical development of INVA8003;

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		(iii) $1.8 million to repay a portion of our outstanding indebtedness to InveniAI under the terms of our line of credit with InveniAI, or the InveniAI Line of Credit; (iv) approximately $ million to pay certain related party secured promissory notes; (v) approximately $ million to repay, if required, certain convertible notes that are not converted in connection with this offering; (vi) approximately $ million to pay outstanding accrued liabilities; (vii) approximately $0.1 million to pay InveniAI for accrued licensing fees under the AlphaMeld License; and (viii) the remainder for general corporate purposes, including working capital, operating expenses and other capital expenditures. See the section titled “Use of Proceeds” for additional information.
Risk factors		Investing in our common stock involves a high degree of risk. You should read the section titled “Risk Factors” for a discussion of factors to consider carefully, together with all of the other information included in this prospectus, before deciding to invest in shares of our common stock.
Proposed Nasdaq Capital Market Symbol		We have applied to list our shares of common stock on the Nasdaq Capital Market under the symbol “INAI”.
Lock-Up Agreements		All of our directors, officers and all holders of our outstanding shares 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 (i) in the case of our executive officers and directors, a period of nine (9) months from the date of the offering, (ii) in the case of any other holder of our shares of common stock or securities convertible into shares of common stock, a period of six (6) months from the date of the offering. Each of the Company and any successors of the Company have agreed, for a period of six (6) months from the closing of the offering, that each will not offer, pledge, sell, contract to sell, sell any option or contract to purchase, purchase any option or contract to sell, grant any option, right or warrant to purchase, lend, or otherwise transfer or dispose of, directly or indirectly, any shares of capital stock of the Company (except pursuant to the Company’s equity incentive plans) or any securities convertible into or exercisable or exchangeable for shares of capital stock of the Company. See “Underwriting” for more information.

The number of shares of our common stock to be outstanding immediately following this offering is based on 11,134,457 shares of our common stock outstanding as of September 30, 2025, after giving effect to the conversion of all of our outstanding shares of preferred stock, including 7,250,000 shares of our Series A preferred stock and 1,092,707 shares of our Series A-1 preferred stock, into an aggregate of 8,342,707 shares of common stock upon the closing of this offering, shares of our common stock issuable upon conversion of an aggregate of $1.2 million of SAFE instruments, or, together, the CEO SAFEs, issued by us to our CEO, and an affiliate of our CEO in March

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2023, which will occur upon the closing of this offering, assuming an initial public offering price of $ per share, which is the midpoint of the price range set forth on the cover page of this prospectus and shares of our common stock upon the mandatory conversion of certain related party convertible debt instruments, which will occur upon the closing of this offering assuming an initial offering price of $ per share, which is the midpoint of the price range set forth on the cover page of this prospectus. Since September 30, 2025, we have not issued any additional shares of common stock.

The number of shares of our common stock to be outstanding immediately following this offering excludes:

• 4,345,250 shares of our common stock issuable upon exercise of stock options under our 2021 Equity Incentive Plan, or the 2021 Plan, outstanding as of September 30, 2025 with a weighted average exercise price of $1.39 per share;

• 53,000 shares of our common stock reserved for future issuance under the 2021 Plan as of September 30, 2025;

• 223,170 shares of our common stock issuable upon exercise of warrants issued in connection with our July 2025 Senior Note (as defined below) outstanding as of September 30, 2025 with an exercise price of $4.81 per share;

• 101,061 shares of our common stock issuable upon exercise of warrants issued after September 30, 2025 with an exercise price of $4.81 per share;

• shares of our common stock reserved for future issuance under our 2025 Equity Incentive Plan, or the 2025 Plan (of which we will grant options to purchase an aggregate of shares of our common stock to certain of our employees and non-employee directors upon the pricing of this offering at an exercise price equal to the initial public offering price), plus a number of shares of common stock not to exceed (consisting of the number of shares that remain available under the 2021 Plan as of immediately prior to the effective date of the 2025 Plan and any shares underlying options outstanding under the 2021 Plan that expire or otherwise terminate prior to exercise or settlement, as applicable, after the effective date of the 2025 Plan), as well as any future increases in the number of shares of common stock reserved for issuance thereunder, as more fully described in the section titled “Executive Compensation — Equity Incentive Plans — 2025 Equity Incentive Plan”;

• shares of our common stock reserved for future issuance under our 2025 Employee Stock Purchase Plan, or the ESPP, which will become effective on the date of the underwriting agreement related to this offering, as well as any automatic increases in the number of shares of common stock reserved for future issuance under the ESPP;

• shares of our common stock issuable upon the conversion of outstanding convertible debt instruments in the principal amount of $ million, assuming an initial public offering price of $ , which is the midpoint of the initial public offering price reflected on the cover of this prospectus; and

Unless otherwise indicated, all information in this prospectus assumes:

• the conversion of all outstanding shares of our preferred stock on a one-for-one basis into shares of our common stock, which will occur upon the closing of this offering;

• the filing and effectiveness of our amended and restated certificate of incorporation, or our amended and restated certificate, immediately prior to the closing of this offering;

• no exercise or cancellation/forfeiture of the outstanding options and warrants referred to above after September 30, 2025;

• no exercise by the underwriters of their option to purchase additional shares of our common stock;

• no exercise of the Representative’s Warrants to purchase up to shares of our common stock at an exercise price equal to 125% of the offering price; and

• no purchase of our shares of common stock by certain of our directors, officers, employees, distributors, dealers, business associates and related persons designated by us through the reserved share program described under “Underwriting — Reserved Shares.”

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SUMMARY FINANCIAL DATA

The following tables set forth our summary financial data for the periods and as of the dates indicated. The following summary statements of operations data for the years ended December 31, 2024, and 2023 have been derived from our audited financial statements included elsewhere in this prospectus. The following summary interim condensed statements of operations data for the nine months ended September 30, 2025, and 2024, and the summary interim condensed balance sheet data as of September 30, 2025, have been derived from our unaudited interim condensed financial statements included elsewhere in this prospectus.

Our audited financial statements included elsewhere in this prospectus have been prepared in accordance with U.S. generally accepted accounting principles, or U.S. GAAP. Our audited financial statements include, in our opinion, all adjustments of a normal and recurring nature that are necessary for the fair statement of the financial information set forth in those statements included elsewhere in this prospectus. Our historical results are not necessarily indicative of the results that may be expected for any period in the future. You should read the following summary financial data together with the section titled “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and our audited financial statements and unaudited interim condensed financial statements and the related notes included elsewhere in this prospectus. The summary financial data included in this section are not intended to replace the financial statements and the related notes included elsewhere in this prospectus.

	Years Ended December 31,						Nine months ended September 30,
(in thousands of USD, except share and per share data)	2024			2023			2025			2024
Statements of Operations Data:								(Unaudited)
Operating costs and expenses:
Research and development	$	2,463		$	5,089		$	495		$	2,179
General and administrative		5,714			3,004			1,542			4,883
Total operating expenses		8,177			8,093			2,037			7,062
Loss from operations		(8,177	)		(8,093	)		(2,037	)		(7,062	)
Interest expense		493			196			523			371
Change in fair value of derivative liability		(1,615	)		1,615			—			(1,266	)
Change in fair value of SAFE		(779	)		(17	)		291			(779	)

Net loss		(6,276	)		(9,887	)		(2,851	)		(5,388	)
Basic and diluted net loss per share attributable to common stockholders	$	(2.45	)	$	(4.21	)	$	(1.06	)	$	(2.13	)
Weighted average common shares outstanding, basic, and diluted(1)		2,558,279			2,348,518			2,699,885			2,533,488
Pro forma net loss per share attributable to common stockholders, basic and diluted (unaudited)(2)
Pro forma weighted average common shares outstanding, basic and diluted (unaudited)(2)

____________

(1) See Note 10 to our audited financial statements and our unaudited interim condensed financial statements included elsewhere in this prospectus for details on the calculation of basic and diluted net loss per share attributable to common stockholders.

(2) Pro forma basic and diluted net loss per share attributable to common stockholders has been prepared to give effect to adjustments to our capital structure arising in connection with the completion of this offering and is calculated by dividing pro forma net loss attributable to common stockholders by the pro forma weighted average common shares outstanding for the period. The unaudited pro forma net loss attributable to common stockholders used in the calculation of unaudited pro forma basic and diluted net loss per share attributable to common stockholders is equal to net loss attributable to common stockholders.

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The unaudited pro forma basic and diluted weighted average common shares outstanding used in the calculation of unaudited pro forma basic and diluted net loss per share for the years ended December 31, 2024 and 2023, and the nine month periods ended September 30, 2025 and 2024, have been prepared to reflect (i) the conversion of all of the outstanding shares of our preferred stock into an aggregate of shares of our common stock, (ii) the issuance of shares of our common stock upon the conversion of $1.2 million of the CEO SAFEs issued by us to our CEO and an affiliate of our CEO in March 2023 and (iii) the issuance of shares of our common stock upon the conversion of outstanding convertible debt instruments in the principal amount of $___, which will occur upon the closing of this offering, assuming an initial public offering price of $ per share, which is the midpoint of the price range set forth on the cover page of this prospectus, as if the conversions had occurred at the beginning of the period, regardless of their issuance dates.

	As of September 30, 2025
	Actual			Pro Forma(1)	Pro Forma As Adjusted(2)
				(in thousands)
Balance Sheet Data:

Cash	$	329		$	$
Debt		11,955
Working (deficit) capital(3)		(9,974	)
Total assets		851
Convertible preferred stock		5,655
Total stockholders (deficit) equity		(22,754	)

____________

(1) Gives effect to the (i) conversion of all of the outstanding shares of our preferred stock into an aggregate of 8,342,707 shares of our common stock upon the closing of this offering, (ii) the issuance of shares of our common stock upon the conversion of $1.2 million of the CEO SAFEs, which will occur upon the closing of this offering, assuming an initial public offering price of $ per share, which is the midpoint of the price range set forth on the cover page of this prospectus, (iii) additional borrowings of $ million under the InveniAI Line of Credit subsequent to September 30, 2025 and (iv) the issuance of shares of our common stock upon the mandatory conversion of certain related party convertible debt instruments, which will occur upon the closing of this offering assuming an initial offering price of $ per share, which is the midpoint of the price range set forth on the cover page of this prospectus.

(2) Gives further effect to (i) the repayment of approximately $1.8 million of aggregate indebtedness under the InveniAI Line of Credit and certain secured related party promissory notes using a portion of the net proceeds of this offering, (ii) payment of approximately $ million to settle outstanding accrued liabilities, (iii) the repayment of approximately $ million of convertible debt, which may convert in connection with this offering, and (iv) the sale of shares of common stock in this offering at an assumed initial public offering price of $ per share, which is the midpoint of the price range set forth on the cover page of this prospectus, after deducting estimated underwriting fees and commissions and estimated offering expenses payable by us. This pro forma as adjusted information is illustrative only and will depend on the actual initial public offering price and other terms of this offering determined at pricing. Each $1.00 increase or decrease in the assumed initial public offering price of $ per share, which is the midpoint of the price range set forth on the cover page of this prospectus, would increase or decrease the pro forma as adjusted amount of each of cash, working (deficit) capital, total assets and total stockholders’ equity by $ 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 and estimated offering expenses payable by us. Each increase or decrease of 1.0 million in the number of shares we are offering would increase or decrease the pro forma as adjusted amount of each of cash, working (deficit) capital, total assets and stockholders’ equity by $ million, assuming no change in the assumed initial public offering price per share and after deducting the estimated underwriting discounts and commissions and estimated offering expenses payable by us.

(3) We define working (deficit) capital as current assets less current liabilities. See our unaudited interim financial statements and related notes as of September 30, 2025, included elsewhere in this prospectus for further details regarding our current assets and current liabilities.

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RISK FACTORS

An investment in our common stock involves a high degree of risk. Before making an investment decision, you should give careful consideration to the following risk factors, in addition to the other information included in this prospectus, including our financial statements and related notes and “Management’s Discussion and Analysis of Financial Condition and Results of Operations,” before deciding whether to invest in our securities. Other risks and uncertainties that we do not presently consider to be material, or of which we are not presently aware, may become important factors that affect our future financial condition and financial performance. The occurrence of any of these, or of any of the adverse developments described in the following risk factors could materially and adversely harm our business, financial condition, results of operations or prospects. In that case, the trading price of our common stock could decline, and you may lose all or part of your investment.

Risks Related to Our Financial Position, Limited Operating History and Need for Additional Capital

We have incurred significant operating losses since inception and anticipate that we will continue to incur significant operating losses for the foreseeable future and may never achieve or maintain profitability.

We have incurred significant operating losses since our inception, and we expect to continue to incur significant expenses and operating losses for the foreseeable future. Our net losses were $2.9 million and $5.4 million for the nine months periods ended September 30, 2025 and 2024, respectively, and $6.3 million and $9.9 million for the years ended December 31, 2024 and 2023, respectively. To date, our business has been primarily financed by InveniAI, in the form of net parent investment and through the InveniAI Line of Credit, as well as net proceeds from the issuance of preferred stock, funds received from issuance of common stock, exercise of stock options, SAFE financings and borrowings from our Chief Executive Officer and his affiliates and through convertible notes. We have no products approved for commercialization and have never generated revenue from product sales.

Only one of our product candidates, INVA8001, has been sufficiently advanced by our licensor to be in a position to commence clinical trials. We intend to submit a CTA to the competent authorities of the relevant EU member states in the second half of 2026. Subject to clearance of a CTA by the competent authorities of the relevant EU member states, we plan to initiate a Phase 2a trial for INVA8001 in the EU shortly thereafter. Following completion of a Phase 2a trial in the EU and subject to the trial achieving its clinical endpoints and regulatory clearance, for which there can be no assurance as the outcome of a Phase 2a trial is inherently uncertain, we intend to expand development of INVA8001 into chronic spontaneous urticaria (the second major form of chronic urticaria), prurigo nodularis, and atopic dermatitis as potential future indications in the United States, or U.S., EU, and globally, contingent on the process for regulatory review of marketing applications in those territories and additional future financing

We have devoted substantially all of our financial resources and efforts to acquiring the rights to and the development of our product candidates, and we expect to continue to incur significant expenses and increasing operating losses for the foreseeable future. We expect that it could be several years, if ever, before we have a commercialized product and generate product sales. Our net losses may fluctuate significantly from quarter to quarter and from year to year. We anticipate that our expenses will increase substantially as we:

• continue to advance the preclinical and clinical development of our current and future product candidates, including our planned clinical trials and manufacturing of INVA8001 and preclinical development of INVA8003, for currently planned and potential future indications;

• pursue regulatory approval for any product candidates that successfully complete clinical trials;

• seek to discover and develop additional product candidates, including through the acquisition or in-licensing of additional product candidates or technologies;

• continue to develop, maintain, expand, and protect our intellectual property portfolio;

• establish a commercialization infrastructure and scale up external manufacturing and distribution capabilities to commercialize any product candidates for which we may obtain regulatory approval;

• adapt our regulatory compliance efforts to incorporate requirements applicable to marketed products;

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• hire additional clinical, manufacturing and manufacturing quality control, regulatory, scientific and administrative personnel;

• add operational, financial and management information systems and personnel, including personnel to support our product development and planned future commercialization efforts; and

• incur additional legal, accounting, and other expenses as a public company.

To become and remain profitable, we must succeed in developing, obtaining regulatory approval for and eventually commercializing product candidates that generate significant revenue. This will require us to be successful in a range of challenging activities, including completing preclinical testing and clinical trials of our product candidates, obtaining regulatory approval, and manufacturing, marketing and selling any product candidates for which we may obtain regulatory approval, as well as discovering and developing additional product candidates or additional indications for existing product candidates. We are only in the preliminary stages of most of these activities and all of our product candidates are in development. We may never succeed in these activities and, even if we do, may never generate any revenue or revenue that is significant enough to achieve profitability.

Even if we achieve profitability, we may not be able to sustain or increase profitability on a quarterly or annual basis. Our failure to become and remain profitable would depress the value of our company and common stock and could impair our ability to raise capital, expand our business, maintain our development efforts, obtain product approvals, diversify our offerings or continue our operations. A decline in the value of our company could also cause you to lose all or part of your investment.

Our recurring losses from operations could continue to raise substantial doubt regarding our ability to continue as a going concern. Our independent registered public accounting firm included in its audit opinion for the year ended December 31, 2024 an explanatory paragraph that there is substantial doubt as to our ability to continue as a going concern. Our ability to continue as a going concern requires that we obtain sufficient funding to finance our operations.

We have incurred significant operating losses since our inception and have never generated product revenue, and it is possible we will never generate product revenue or profit. Meaningful revenues will likely not be available until and unless any current or future product candidates are approved by the European Commission, U.S. FDA or comparable regulatory agencies in other countries and successfully marketed, either by us or a partner, an outcome which may not occur. Accordingly, we have concluded that substantial doubt exists regarding our ability to continue as a going concern. Our audited financial statements appearing at the end of this prospectus have been prepared on a going concern basis, which contemplates the realization of assets and satisfaction of liabilities in the ordinary course of business. Our management has concluded, and in its report on our financial statements for the year ended December 31, 2024, our independent registered public accounting firm included an explanatory paragraph due to our reliance on the support of our stockholders to fund our operations and lack of sufficient capital to fund operations for the next 12 months raising substantial doubt about our ability to continue as a going concern. Furthermore, even after giving effect to the proceeds from this offering, substantial doubt may continue to exist regarding our ability to continue as a going concern. If we are unable to continue as a going concern, we may have to liquidate our assets and may receive less than the value at which those assets are carried on our financial statements, and it is likely that investors will lose all or a part of their investment. Further, the perception that we may be unable to continue as a going concern may impede our ability to pursue strategic opportunities or operate our business due to concerns regarding our ability to discharge our contractual obligations. In addition, if there remains substantial doubt about our ability to continue as a going concern, investors or other financing sources may be unwilling to provide additional funding to us on commercially reasonable terms, or at all.

We have a limited operating history and have never generated product revenues, which may make it difficult to evaluate the success of our business to date and to assess our future viability.

We are a clinical-stage biopharmaceutical company with a limited operating history upon which you can evaluate our business and prospects and base your investment decision. We historically operated as part of our parent, InveniAI, up to the date of our incorporation on October 20, 2021.

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Our operations to date have been largely focused on organizing and staffing our company, raising capital and acquiring the rights to, and advancing the clinical and preclinical development of, our product candidates. We have not yet demonstrated an ability to successfully complete clinical trials, obtain marketing approvals, manufacture products on a commercial scale or arrange for a third party to do so on our behalf, or conduct sales and marketing activities necessary for successful commercialization. Some of the preclinical and clinical development of INVA8001 to date has been conducted by our licensor. Consequently, predictions about our future success or viability may not be as accurate as they could be if we had a longer operating history or a history of successfully developing and commercializing products.

We expect our financial condition and operating results to continue to fluctuate from quarter to quarter and year to year due to a variety of factors, many of which are beyond our control. We will need to eventually transition from a company with a research and development focus to a company capable of undertaking commercial activities. We may encounter unforeseen expenses, difficulties, complications, regulatory obstacles and delays, and may not be successful in such a transition.

Even if this offering is successful, we will need substantial additional funding, and if we are unable to raise capital when needed, we could be forced to delay, reduce or eliminate our product development programs or commercialization efforts.

Our operations have consumed substantial amounts of cash since inception. Identifying potential product candidates and conducting preclinical testing and clinical trials 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 achieve product sales. We expect to continue to incur significant and increasing expenses and operating losses for the foreseeable future as we initiate and conduct clinical trials of our current and potential future product candidates, advance our preclinical programs, seek marketing and regulatory approval for any product candidates that successfully complete clinical trials and commercialize our products, if approved, and service our indebtedness to the extent not repaid with proceeds of this offering. Because the outcome of any clinical trial or preclinical study is highly uncertain, we cannot reliably estimate the actual amount of financing necessary to successfully complete the development and commercialization of any of our product candidates.

In addition, our product candidates, if approved, may not achieve commercial success. Our revenue, if any, will be derived from sales of products that we do not expect to be commercially available for a number of years, if at all. If we obtain marketing approval for any product candidates that we develop or otherwise acquire, we expect to incur significant commercialization expenses related to product sales, marketing, distribution and manufacturing. We also expect an increase in our expenses associated with creating additional infrastructure to support operations as a public company.

As of September 30, 2025, we had $0.3 million of cash on hand. We believe that the anticipated net proceeds from this offering, together with our existing cash, will be sufficient to fund our operating expenses and capital requirements for the next months. This estimate is based on assumptions that may prove to be wrong, and we could use our available capital resources sooner than we expect. Changes may occur beyond our control that would cause us to consume our available capital before that time, including but not limited to changes in and progress of our development activities, acquisitions of additional product candidates, and changes in regulation. Our future capital requirements will depend on many factors, including:

• the scope, progress, costs, timing and results of discovery, preclinical development, laboratory testing and clinical trials for INVA8001, INVA8003 and future product candidates, including any modifications to clinical development plans based on feedback we may receive from regulatory authorities;

• the extent to which we develop, in-license or acquire other product candidates and technologies in our pipeline;

• the costs and timing of process development and manufacturing scale-up activities associated with our product candidates and other programs as we advance them through preclinical and clinical development and, if approved, commercialization;

• the number and development requirements of product candidates that we may pursue;

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• the timing and amount of the milestone, royalty or other payments we must make to Daiichi Sankyo, from whom we have in-licensed INVA8001, or any future licensors;

• the costs, timing and outcome of regulatory review of our product candidates;

• our headcount growth and associated costs as we expand our research and development capabilities and establish a commercial infrastructure;

• the costs and timing of future commercialization activities, including product manufacturing, marketing, sales and distribution, for any of our product candidates for which we receive marketing approval;

• the costs and timing of preparing, filing and prosecuting patent applications, maintaining and enforcing our intellectual property rights and defending any intellectual property-related claims;

• our ability to achieve sufficient market acceptance, coverage and adequate reimbursement from third-party payors (or patients’ willingness to pay out-of-pocket for any approved products in the absence of such coverage) and adequate market share and revenue for any approved products, if any;

• the revenue, if any, received from commercial sales of our product candidates for which we receive marketing approval; and

• the costs of operating as a public company.

We will require additional capital to achieve our business objectives. Additional funds may not be available on a timely basis, on favorable terms or at all, and such funds, if raised, may not be sufficient to enable us to continue to implement our long-term business strategy. Further, our ability to raise additional capital may be adversely impacted by potentially worsening global economic conditions and the recent disruptions to and volatility in the credit and financial markets in the U.S. and worldwide resulting from factors that include but are not limited to, inflation, tariffs, trade restrictions, the Russia-Ukraine conflict and conflicts in the Middle East, diminished liquidity and credit availability, declines in consumer confidence, declines in economic growth, increases in unemployment rates, uncertainty about economic stability, and other factors. If the equity and credit markets deteriorate, it may make any necessary debt or equity financing more difficult to obtain, more costly and more dilutive. If we are unable to raise sufficient additional capital, we could be forced to curtail our planned operations and the pursuit of our growth strategy, or even cease operations.

Raising additional capital may cause dilution to our stockholders, restrict our operations or require us to relinquish rights to our technologies or product candidates.

Until such time, if ever, as we can generate substantial revenue, we may finance our cash needs through a combination of equity offerings, government or private party grants, debt financings and license and collaboration agreements. We do not currently have any committed external source of funds. To the extent that we raise additional capital through the sale of equity or convertible debt securities, your ownership interest may be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect your rights as a common stockholder. Debt financing and preferred equity financing, if available, may involve agreements that include covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures or declaring dividends. Such restrictions could adversely impact our ability to conduct our operations and execute our business plan.

If we raise additional funds through collaborations, strategic alliances or marketing, distribution or licensing arrangements with third parties, we may be required to relinquish valuable rights to our technologies, future revenue streams, intellectual property or product candidates, grant licenses on terms that may not be favorable to us and/or that may reduce the value of our common stock or commit us to future payment streams. If we are unable to raise additional funds through equity or debt financings when needed or on terms acceptable to us, we may be required to delay, limit, reduce or terminate our product development or future commercialization efforts or grant rights to develop and market product candidates that we would otherwise prefer to develop and market ourselves, or on less favorable terms than we would otherwise choose.

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We may not be able to refinance, extend or repay our substantial indebtedness owed to our note holders, which would have a material adverse effect on our financial condition and ability to continue as a going concern.

We anticipate that we will need to raise a significant amount of debt or equity capital in the near future in order to repay our outstanding debt obligations owed to our noteholders when they mature.

On September 20, 2023, the Company entered into a secured promissory note, or, as amended, the Secured Nandabalan Note, with The Nandabalan Trust 2020, dated July 24, 2020, the CEO’s trust, or the Nandabalan 2020 Trust, for a principal amount of $0.3 million. The Secured Nandabalan Note accrued interest at a rate of 15% per annum, calculated based on a 365/366-day year, as applicable, and actual days elapsed. Additionally, pursuant to the terms of the Secured Nandabalan Note, if any amount payable was not paid when due, whether at stated maturity, by acceleration, or otherwise, such overdue amount would bear interest at 20% per annum. The Secured Nandabalan Note was amended on September 19, 2024 and on October 28, 2025, and was to mature on March 31, 2026. As of September 30, 2025, we owed approximately $0.4 million inclusive of principal and interest on the Secured Nandabalan Note.

On January 31, 2025, the Company entered into a related party convertible promissory note, or the January 2025 Convertible Note, with the Nandabalan Trust 2020 for a principal sum of $0.15 million at an interest rate of 12% per annum. The January 2025 Convertible Note had a mandatory automatic conversion feature upon the Company receiving aggregate proceeds of at least $20.0 million in an equity financing. The conversion price was to be determined pursuant to a contractual formula that would result in a price per share that would be lower than the price paid by new investors in such financing. If not converted, all principal and accrued interest would be paid by February 1, 2026. As of September 30, 2025, we owed approximately $0.16 million inclusive of principal and interest on the January 2025 Convertible Note.

On November 1, 2025, the Company entered into a Consolidated Convertible Promissory Note, or the Consolidated Note, with the Nandabalan 2020 Trust, as holder, in the principal amount of approximately $0.6 million. The Consolidated Note amended, restated, and replaced (i) the Secured Nandabalan Note and (ii) the January 2025 Convertible Note. The Consolidated Note bears interest at 7.5% per annum, matures on December 31, 2026, and contains a mandatory conversion feature into shares of capital stock upon the occurrence of the Company receiving aggregate cash proceeds of at least $10.0 million in a financing event to third parties. The Consolidated Note is unsecured, and all liens granted under the prior notes were released in connection with the entry into the Consolidated Note.

On May 28, 2024, the Company entered into a secured promissory note with the Nandabalan 2020 Trust for a principal amount of $0.35 million, which was amended on September 29, 2025, or, as amended, the 2024 Trust Note. The 2024 Trust Note accrues interest at a rate of 9.5% per annum, calculated based on a 365/366-day year, as applicable, and actual days elapsed. Additionally, pursuant to the terms of the 2024 Trust Note, if any amount payable is not paid when due, whether at stated maturity, by acceleration, or otherwise, such overdue amount will bear interest at 14.5% per annum. The 2024 Trust Note matures on May 27, 2026. As of September 30, 2025 we owed approximately $0.4 million inclusive of principal and interest on the 2024 Trust Note.

On October 23, 2024, and October 29, 2024, respectively, the Company entered into two secured promissory notes with the CEO for a principal amount of approximately $0.195 million, or, as amended, the October 2024 Secured Notes. The October 2024 Secured Notes accrue interest at a rate that is 9.5% per annum, calculated based on a 365/366-day year, as applicable, and actual days elapsed. Additionally, pursuant to the terms of the October 2024 Secured Notes, if any amount payable is not paid when due, whether at stated maturity, by acceleration, or otherwise, such overdue amount will bear interest at 14.5%. On October 17, 2025, the October 2024 Secured Notes were amended such that the respective principal amount and all accrued and unpaid interest thereunder shall be due and payable on April 22, 2026 for the October 2024 Secured Note with a principal amount of $0.165 million and April 28, 2026 for the October 2024 Secured Note with a principal amount of $0.03 million. As of September 30, 2025, we owed approximately $0.2 million inclusive of principal and interest on the October 2024 Secured Notes.

On March 31, 2025, the Company issued two convertible promissory notes to certain accredited investors for a total principal amount of $0.3 million, as amended on October 27, 2025, and October 29, 2025, respectively, or the March 2025 Notes. The amendments increased the principal amount of each March 2025 Note from $0.15 million to $0.165 million, for a total principal amount of $0.33 million. The March 2025 Notes bear interest at 18% per annum and mature on December 31, 2025, unless earlier converted or extended by the holder. At the option of the

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holders, the March 2025 Notes are convertible into the same class of equity securities issued in the Company’s next qualified equity financing where the Company raises at least $10.0 million at a 30% discount to the price paid by new investors. If a non-qualified financing occurs, the holder may elect to treat it as a qualified financing for conversion purposes. As of September 30, 2025, the outstanding principal and accrued interest totaled $0.3 million on the March 2025 Notes.

On July 2, 2025, the Company issued to Ascent Partners Fund LLC, or Ascent Partners, a Senior Secured Convertible Promissory Note, or the July 2025 Senior Note, with an aggregate principal amount of $1.1 million for gross cash proceeds of $0.95 million. The difference between the face value and cash proceeds represents an original issue discount of $0.12 million. The July 2025 Senior Note bears interest at 10% per annum, matures on September 1, 2026, and is convertible at the holder’s option into shares of the Company’s common stock at a conversion price equal to 70% of the price per share paid by investors in the Company’s initial public offering or 70% of the price per share implied by the valuation of the Company at the closing of a direct listing of the Company’s securities on a trading market, a reverse takeover or a business combination with a special purpose acquisition company or, if no such transaction has occurred, $4.80 per share, subject to adjustment for stock splits and similar events. The July 2025 Senior Note includes customary covenants and events-of-default provisions and is secured by substantially all the Company’s assets. As of September 30, 2025, we owed approximately $1.2 million inclusive of principal and interest on the July 2025 Senior Note.

On November 19, 2025, the Company issued to Ascent Partners a Senior Secured Convertible Promissory Note, or the November 2025 Senior Note, with an aggregate principal amount of approximately $0.37 million for gross cash proceeds of $0.3 million. The difference between the face value and cash proceeds represents an original issue discount of approximately $0.07 million. The November 2025 Senior Note bears interest at 10% per annum, matures on the earlier of (i) August 19, 2026 or (ii) the closing date of the Company’s initial public offering, and is convertible at the holder’s option into shares of the Company’s common stock at a conversion price equal to 70% of the price per share paid by investors in the Company’s initial public offering or 70% of the price per share implied by the valuation of the Company at the closing of a direct listing of the Company’s securities on a trading market, a reverse takeover or a business combination with a special purpose acquisition company or, if no such transaction has occurred, $4.81 per share, subject to adjustment for stock splits and similar events. The November 2025 Senior Note includes customary covenants and events-of-default provisions and is secured by substantially all the Company’s assets.

We cannot provide any assurances that we will be able to raise the necessary amount of capital to repay these obligations or that we will be able to extend the maturity dates or otherwise refinance these obligations. Upon a default in the debt our noteholders would have the right to exercise their rights and remedies to collect, which would include foreclosing on our assets. Accordingly, a default would have a material adverse effect on our business and, if our noteholders exercise its rights and remedies, we would likely be forced to seek bankruptcy protection.

Unfavorable global conditions could adversely affect our business, financial condition or results of operations.

Our results of operations could be adversely affected by general conditions in the global economy and in the global financial markets, including decades-high inflation, the imposition of tariffs and concerns of a recession in the United States or other major markets due to a number of factors. For example, Russia’s invasion of Ukraine and the Middle East conflicts may lead to a prolonged, adverse impact on global economic, sociopolitical and market conditions. A severe or prolonged economic downturn could result in a variety of risks to our business, including weakened demand for our product candidates, and impair our ability to raise additional capital when needed or on acceptable terms, if at all. A weak or declining economy, sanctions, tariffs, trade restrictions and other global conditions could also strain our suppliers, possibly resulting in supply delays or disruption. While inflation in the United States has been relatively low in recent years, during 2023, 2024 and 2025 to date, the economy in the United States encountered a material level of inflation. The impact of geopolitical developments such as the Russia-Ukraine conflict and conflicts in the Middle East, U.S. monetary policy, new or increased tariffs imposed on imports from countries where our suppliers operate, and global supply chain disruptions continue to increase uncertainty in the outlook of near-term and long-term economic activity, including whether inflation and tariffs will continue, for how long, and at what rate. Increases in inflation and tariffs raise our costs for labor, materials

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and services and other costs required to grow and operate our business, and failure to secure these on reasonable terms may adversely impact our financial condition. Any of the foregoing could harm our business and we cannot anticipate all of the ways in which the current economic climate and financial market conditions could adversely impact our business, financial condition, results of operations and prospects.

Our quarterly and annual operating results may fluctuate significantly, which makes it difficult for us to predict our future operating results and could cause our operating results to fall below expectations or any guidance we may provide. These fluctuations may occur due to a variety of factors, many of which are outside of our control, including:

• the timing and cost of, and level of investment in, research, development, regulatory approval and commercialization activities relating to our product candidates, which may change from time to time;

• the timing and success or failure of preclinical studies or clinical trials for our product candidates or competing product candidates, or any other change in the competitive landscape of our industry, including consolidation among our competitors or partners;

• coverage and reimbursement policies with respect to our product candidates, if approved, and potential future drugs that compete with our products;

• expenditures that we may incur to acquire, develop or commercialize additional product candidates and technologies;

• the level of demand for any approved products, which may vary significantly;

• future accounting pronouncements or changes in our accounting policies;

• the timing and amount of any milestone, royalty or other payments payable by us or due to us under any collaboration, licensing or other similar agreement; and

• changes in general market and economic conditions.

The cumulative effects of these factors could result in large fluctuations and unpredictability in our quarterly and annual operating results. As a result, comparing our operating results on a period-to-period basis may not be meaningful. Investors should not rely on our past results as an indication of our future performance.

This variability and unpredictability could also result in our failing to meet the expectations of industry or financial analysts or investors for any period. If our operating results fall below the expectations of analysts or investors or below any forecasts we may provide to the market, or if the forecasts we provide to the market are below the expectations of analysts or investors, the price of our common stock could decline substantially. Such a stock price decline could occur even when we have met any previous guidance we may have provided.

Risks Related to the Discovery and Development of our Product Candidates

Our approach to the discovery and development of product candidates based on the AlphaMeld Platform is unproven, and we do not know whether we will be able to develop any products of commercial value, or if competing technological approaches will limit the commercial value of our product candidates or render our platform obsolete.

Our business strategy relies in part on our ability to identify, validate, and advance product candidates originating from the AlphaMeld Platform (our proprietary target association network). While we believe this approach may enable faster hypothesis generation and target/pathway prioritization in IMIDs, it remains novel and unproven at clinically meaningful scale. Any product candidates identified by the AlphaMeld Platform may fail to demonstrate safety, pharmacokinetics, pharmacodynamics, or efficacy in preclinical studies or clinical trials, including proof-of-mechanism and proof-of-concept studies, and may not result in regulatory approval or commercial success.

Our success depends on numerous factors, many of which are outside our control, including: the completeness and quality of the disparate data our system ingests; the ability of our models to correctly infer causal biology rather than correlations; the selection and qualification of biomarkers and patient-enrichment strategies; the performance of

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third-party CROs and collaborators; and the translatability of preclinical models to human disease. If our discovery engine yields false positives (advancing ineffective concepts) or false negatives (excluding promising biology), we could invest significant time and resources without generating regulatory-approved products.

Moreover, the competitive landscape for AI-enabled discovery and IMID therapeutics is rapidly evolving. Larger or better-resourced companies, academic groups, and new entrants may develop superior computational methods, access higher-quality data, out-license priority targets, or advance alternative therapeutic modalities (e.g., next-generation biologics, cell therapies) that could reduce the commercial potential of our candidates or make our discovery engine less competitive. Even if we generate clinically active product candidates, competitors may reach the market first, obtain broader labels, secure advantageous pricing or reimbursement, or establish stronger intellectual property, which could materially and adversely affect our business, financial condition, and results of operations.

Our AlphaMeld Platform-based product candidates are based on a novel technology, which makes it difficult to predict the time and cost of product candidate development.

Product candidates sourced through our discovery engine involve scientific, technical, operational, and regulatory uncertainties that complicate planning and cost estimation. For example, (i) our reliance on multi-modal datasets (literature, omics, real-world evidence) requires continuous curation and quality control; (ii) updates to algorithms, feature sets, or training corpora may alter model outputs and require us to re-justify target selection, repeat in vitro/in vivo validation, or conduct bridging studies; (iii) regulators may request enhanced documentation of data lineage, model versioning, and decision rationale underlying candidate nomination, as well as additional nonclinical work to support biomarker strategies or patient selection; and (iv) if we employ companion or complementary diagnostics, their development, analytical validation, and regulatory review could add cost, complexity, and risk to our timelines.

Further, candidates addressing complex IMID biology may require novel endpoints, enrichment criteria, or adaptive trial designs, which can be time-consuming to negotiate and operationalize and may face regulatory uncertainty. Chemistry, manufacturing, and controls (CMC) risks — such as process development, scale-up, comparability, and supply chain robustness — may emerge late and require unplanned investment. We also depend on third parties for critical activities (data providers, CROs, CDMOs, academic collaborators); performance issues, capacity constraints, or compliance lapses at any of these parties could lead to additional studies, protocol amendments, or delays. As a result, actual timelines and costs to achieve key milestones (including IND/CTA clearance, first-in-human, proof-of-concept, and pivotal trials) may differ materially from our expectations, and we may need to raise additional capital or on worse terms than anticipated.

We are currently substantially dependent on the success of INVA8001, which is our lead product candidate. If we are unable to advance INVA8001 in clinical development, obtain regulatory approval and ultimately commercialize INVA8001 or if we experience significant delays in doing so, our business will be materially harmed.

We currently have only two product candidates in development, INVA8001, the intellectual property for which we have in-licensed from Daiichi Sankyo and which we plan to progress into Phase 2a of clinical development for chronic inducible urticaria in the EU, subject to regulatory approval, and INVA8003, which is in the early stage of preclinical development. Our business presently depends substantially on our ability to successfully develop, obtain regulatory approval for and commercialize INVA8001 in a timely manner. This may make an investment in our company riskier than similar companies that have multiple product candidates in active development and may be able to better sustain the delay or failure of a lead product candidate. Our assumptions about INVA8001’s development potential are based on the data generated from preclinical studies and clinical trials conducted by our licensor and our belief that INVA8001 will be shown to be effective with the new indication and trial design. INVA8001 has previously failed to meet all endpoints in a Phase 2 clinical trial conducted by our licensor in a different disease indication, and it may fail to do so in our planned clinical trials, as well, despite changes in the clinical trial design, dose and dosing regimen. We may also observe materially and adversely different safety results as we continue to conduct our clinical trials.

The success of INVA8001 will depend on several factors, including the following:

• successful initiation and enrollment of clinical trials and completion of clinical trials with favorable results;

• acceptance of regulatory submissions by competent authorities of the relevant EU member states, U.S. FDA or comparable foreign regulatory authorities for the conduct of preclinical studies and clinical trials of INVA8001 and our proposed design of planned preclinical studies and clinical trials of INVA8001;

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• the frequency and severity of adverse events in preclinical and clinical trials;

• maintaining relationships with preclinical vendors to ensure successful completion of preclinical studies with favorable results, including toxicology and other studies designed to be compliant with good laboratory practices, or GLP;

• maintaining and establishing relationships with contract research organizations, or CROs, and clinical sites for the clinical development of INVA8001, and ability of such CROs and clinical sites to comply with clinical trial protocols, current good clinical practices, or cGCPs, and other applicable requirements;

• demonstrating the safety and efficacy of INVA8001 to the satisfaction of applicable regulatory authorities;

• receipt and maintenance of marketing approvals from applicable regulatory authorities for initial and additional indications;

• maintain relationships with our third-party manufacturers and their ability to comply with current good manufacturing practices, or cGMPs, as well as making arrangements with our third-party manufacturers for commercial manufacturing capabilities at a cost and scale sufficient to support commercialization;

• establishing sales, marketing and distribution capabilities and launching commercial sales of INVA8001, if and when approved, whether alone or in collaboration with others;

• obtaining, establishing, maintaining and enforcing patent and any potential trade secret protection or regulatory exclusivity for INVA8001;

• maintaining an acceptable safety profile of INVA8001 following regulatory approval, if any;

• maintaining and growing an organization of people who can develop and, if approved, commercialize, market and sell INVA8001; and

• acceptance of INVA8001 if approved, by patients, the medical community and third-party payors, for its approved indications.

If we are unable to develop, receive marketing approval for and successfully commercialize INVA8001, or if we experience delays as a result of any of the above factors or otherwise, our business would be significantly harmed.

We were not involved in the early development of INVA8001; therefore, we are dependent on third parties having accurately generated, collected, interpreted and reported data from certain preclinical and clinical trials for INVA8001, which were conducted between 2011 and 2014. We may fail to demonstrate effectiveness of INVA8001 despite a different clinical trial design, and we may observe safety concerns with INVA8001 that have not been observed to date.

We had no involvement with or control over the preclinical and clinical development of INVA8001 performed by the licensor, Daiichi Sankyo. We have in-licensed the rights to research, develop and commercialize INVA8001 from Daiichi Sankyo. We are dependent on preclinical study and clinical trial data developed by Daiichi Sankyo and its licensees having conducted their research and development in accordance with the applicable protocols and legal, regulatory and scientific standards; having accurately reported the results of all preclinical studies and clinical trials conducted with respect to such product candidates, which were conducted between 2011 and 2014; and having correctly collected and interpreted the data from these trials, particularly because our planned trial design and our expectations about the efficacy and safety of INVA8001 are based on our analysis of this data. If these activities were not compliant, accurate or correct, the clinical development, regulatory approval or commercialization of INVA8001 will be adversely affected. Additionally, it has generally been more than a decade since these trials were conducted and the scientific community’s and regulators’ view of the outcome or any safety or benefit claimed from these trials may have declined over time due to factors including but not limited to new medical or regulatory standards, which would adversely impact the strength of any positive outcome from the trials. The length of time since the trials were conducted may also necessitate increased interactions with regulators to discuss the clinical development plan and we cannot assure you that the outcomes of any such meeting would be beneficial and not harmful to our regulatory strategy.

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Results of the various preclinical studies and clinical trials conducted by Daiichi Sankyo between 2011 and 2014 and its licensees have been shared with the U.S. FDA and we expect that these data will be included, as necessary, in any application we may submit for regulatory approval of INVA8001 with the European Commission/EMA, U.S. FDA, and other regulatory agencies. However, the data we produce in our own clinical trials of INVA8001 will ultimately help form the basis of any application for regulatory approval of INVA8001 that we may submit. Daiichi Sankyo failed to demonstrate efficacy of INVA8001 in its Phase 2 clinical trial for atopic dermatitis. We do not know how INVA8001 will perform in our planned Phase 2a clinical trial and any future clinical trials as a result of differences in design from the clinical trials conducted to date by Daiichi Sankyo or other third parties. The differences in our planned Phase 2a clinical trial include, among other things: different doses and dosing regimen, a different manufacturer than Daiichi Sankyo used in its clinical trials, a different indication of chronic inducible urticaria, a longer duration of the clinical trial and a collection of biomarker data relevant to the mechanism of action in mast cell survival and proliferation. It is possible that we may not be able to establish efficacy of INVA8001 in our planned Phase 2a trial, despite a different trial design. Also, it is possible that the increased dose, more frequent dosing regimen, longer trial duration and other aspects of our planned (subject to regulatory clearance) Phase 2a clinical trial will be associated with more serious or frequent adverse events. Any of the foregoing could require us to conduct additional trials or otherwise change our clinical development plan. Ultimately, the risk-benefit profile of INVA8001 may be unacceptable, in chronic inducible urticaria or any other indication and regulators may not permit us to conduct Phase 3 trials of INVA8001 which will be necessary for any marketing approval.

We have had limited interactions with the EMA, U.S. FDA, and other comparable foreign regulatory authorities to date and cannot be certain how many clinical trials of INVA8001 will be required to support marketing approval or how such trials would need to be designed. Further, the U.S. FDA, EU member state authorities or comparable foreign regulatory authorities may not view our current trial designs, any future trial designs, or data, including the data from our planned Phase 2a clinical trial, which is subject to regulatory clearance, as well as the results of clinical trials conducted by Daiichi Sankyo between 2011 and 2014 and other third parties that we include, as required, with any application we may submit for regulatory approval, as sufficient to support the regulatory approval of INVA8001 for the treatment of chronic inducible urticaria or for other indications. For example, although we have discussed a Phase 2b trial design for atopic dermatitis with the U.S. FDA during a pre-IND meeting, our plans for the design and disease indication of the Phase 2 trial have changed since that meeting to focus on chronic inducible urticaria as the first indication. Subject to regulatory clearance, we plan to conduct a Phase 2a trial of INVA8001 for chronic inducible urticaria in the EU with approximately 30 subjects across a placebo and two active arms. We cannot be certain that the data we collect will be sufficient to support commencing late-stage trials. In addition, while we intend to submit a CTA to EU member state authorities under Regulation EU No 536/2014, or the Clinical Trials Regulation or CTR, and not the U.S. FDA for INVA8001 in chronic inducible urticaria in the second half of 2026, there can be no guarantee that these authorities will view our current trial design as sufficient or that they will not require us to conduct additional nonclinical studies or clinical trials, including another Phase 1 trial, until we file and receive clearance of a CTA. Additionally, the competent regulatory authorities may disagree with the adequacy of our trial designs. Competent authorities may also require us to conduct additional nonclinical studies or clinical trials. As a result, we could be required to conduct additional nonclinical studies and clinical trials prior to seeking and obtaining regulatory approval and our planned development timeline, capital requirements and costs of operation could materially change.

We are very early in our development efforts. If we are unable to successfully develop, receive regulatory approval for and commercialize our product candidates for their initial indications or any other indications or successfully develop any other product candidates or experience significant delays in doing so, our business will be substantially harmed.

We are very early in our development efforts. Each of our product candidates will require additional preclinical and/or clinical development, regulatory approval, obtaining manufacturing supply, capacity and expertise, building a commercial organization or successfully outsourcing commercialization, substantial investment and significant marketing efforts before we generate any revenue from product sales. Our assumptions about INVA8001’s development potential are based on the data generated from preclinical studies and clinical trials conducted by our licensor and our belief that INVA8001 will be shown to be effective if clinical development design is changed in accordance with our plans. However, INVA8001 has previously failed to meet all endpoints in a Phase 2 clinical trial for atopic dermatitis conducted by our licensor, and it may fail to do so in our planned clinical trials, as well. We may also observe materially and adversely different safety results as we continue to conduct our clinical trials. Neither

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we nor our licensor conducted any preclinical or clinical trials of INVA8001 in any of our planned indications except atopic dermatitis. Due to material differences in human and animal chymase, it is not possible to test the effectiveness of INVA8001 for any indication in animal models. No animal model efficacy data is available for INVA8001 in chronic inducible urticaria, and we would not be able to obtain such data for any other indications of INVA8001. Accordingly, we would be required to undertake significant expenses to commence testing INVA8001 in humans without any evidence of its efficacy in a particular indication, which makes our development process more expensive and less certain.

Furthermore, we have limited exploratory preclinical data with respect to toxicology of INVA8003, and no preclinical or clinical data with respect to its efficacy or safety. No other product candidate targeting inflammasomes has been successfully developed to date, and the INVA8003 mechanism of action has not been validated.

The foregoing makes our ability to successfully and timely complete development of our product candidates and obtain regulatory approval for them less certain. Failure to do so would have a material adverse effect on our business, financial condition, results of operations and prospects.

We do not have any products that are approved for commercial sale, and we may never be able to develop or commercialize marketable products.

Our ability to generate revenue from our product candidates, which we do not expect will occur for the foreseeable future, if ever, will depend heavily on the successful development, regulatory approval and eventual commercialization of our product candidates. The success of INVA8001, INVA8003 or any other product candidates that we develop or acquire will depend on several factors, including:

• timely and successful initiation, enrolment and completion of preclinical studies and clinical trials with favorable safety and efficacy results;

• sufficiency of our financial and other resources to initiate and complete the necessary pre-clinical studies and clinical trials;

• acceptance of INDs by the U.S. FDA or comparable foreign applications that allow commencement of our planned or future clinical trials for our product candidates;

• establishing and maintaining relationships with CROs and clinical sites for the clinical development of our product candidates, and the ability of such CROs and clinical sites to comply with clinical trial protocols, cGCPs and other applicable requirements;

• successful development of, or making arrangements with third-party manufacturers for, our commercial manufacturing processes for any of our product candidates that receive regulatory approval and successfully manufacturing such product candidates on a commercial scale and in compliance with our specifications and cGMPs;

• timely receipt of marketing approvals from applicable regulatory authorities;

• timely and successfully establishing sales, marketing and distribution capabilities and launching commercial sales of products, if approved, whether alone or in collaboration with others;

• acceptance of our products, if approved, by patients, the medical community and third-party payors, for their approved indications;

• the prevalence and severity of adverse events experienced with INVA8001, INVA8003 or any future product candidates;

• the availability, perceived advantages, cost, safety and efficacy of alternative therapies for any product candidate that we develop, and any indications for such product candidate;

• obtaining and maintaining patent, trademark and trade secret protection and regulatory exclusivity for our current or future product candidates and otherwise protecting our rights in our intellectual property portfolio, in the United States and internationally;

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• maintaining compliance with regulatory requirements, including cGMPs, and complying effectively with other procedures;

• maintaining a continued acceptable safety, tolerability and efficacy profile of products following approval; and

• maintaining and growing an organization of people who can develop and, if approved, commercialize, market and sell INVA8001, INVA8003 and any future product candidates and products.

We do not have complete control over many of these factors, including certain aspects of clinical development and the regulatory submission process, potential threats to our intellectual property rights and the manufacturing, marketing, distribution and sales efforts of any future collaborator. If we are not successful with respect to one or more of these factors in a timely manner or at all, we could experience significant delays or an inability to successfully commercialize the product candidates we develop, which would materially harm our business. If we do not receive marketing approvals for INVA8001, INVA8003 or any future product candidate we develop or if we experience delays in such approvals, we may not be able to continue our operations.

Further, conducting clinical trials in foreign countries, as we expect to do for at least one of our current product candidates, presents additional risks that may delay completion of our clinical trials. These risks include the failure of enrolled patients in foreign countries to adhere to clinical protocol as a result of differences in healthcare services or cultural customs, failure to properly translate or interpret patient-reported outcome endpoints, managing additional administrative burdens associated with foreign regulatory schemes as well as political and economic risks relevant to such foreign countries.

Regulatory requirements in the European Union, European Economic Area and the United Kingdom, or, together, Europe, are complex, evolving, and may delay or prevent the development and approval of our product candidates.

Conducting clinical trials and obtaining regulatory approvals specifically in the EU and European Economic Area, or EEA, is subject to extensive and evolving regulations that may increase costs, create delays, or prevent us from completing our planned clinical development programs. Our ability to conduct clinical trials in Europe depends on obtaining approval under the CTR, which became effective in January 2022 and introduced a centralized submission and assessment process via the Clinical Trials Information System, or CTIS. However, as this regulatory framework continues to transition, procedural inefficiencies, country-specific requirements, or unforeseen delays in regulatory reviews could negatively impact our ability to initiate and complete trials on schedule.

The approval process for a CTA in the EU and EEA requires regulatory reviews and ethics committee approvals in each participating country. Differences in regulatory interpretations, additional national requirements, and requests for further documentation could delay approvals, increasing the time and cost required to advance our product candidates. In addition, patient recruitment and retention challenges — such as competition from other trials, country-specific variations in medical practices, and regulatory restrictions on patient incentives — could further impact trial timelines. If we fail to recruit patients efficiently, our clinical trials could be delayed, which may adversely affect our overall development strategy. Furthermore, ethical review processes in different EU member states may vary, leading to inconsistencies in approval timelines and additional regulatory complexity.

Our trials in the EU and EEA are also subject to data protection laws, including Regulation (EU) 2016/679, also known as the General Data Protection Regulation, or GDPR, which imposes strict requirements on collection, processing, and cross-border transfer of personal data. Failure to comply with GDPR could result in regulatory penalties, legal liabilities, or disruptions to our clinical data collection, potentially delaying regulatory filings. Furthermore, ethical review processes in different EU member states may vary, leading to inconsistencies in approval timelines and additional regulatory complexity.

Additionally, Brexit has created further regulatory divergence between the EU and the United Kingdom, or the UK, requiring separate regulatory approvals from the MHRA for any clinical trials conducted in the UK. If we pursue trials in both jurisdictions, we may face increased administrative burdens, additional costs, and delays associated with parallel regulatory submissions. In the UK, clinical trials are governed by the Medicines for Human Use (Clinical Trials) Regulations 2004, or the UK CTR, which are based on the predecessor EU regulations to the

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CTR. The CTRs have not been adopted in the UK. In April 2025, amendments to the UK CTR were signed into law (the Medicines for Human Use (Clinical Trials)(Amendment) Regulations 2025). These regulations amend the UK CTR, and will take effect on April 28, 2026. The amended UK CTR includes changes on transparency, approval pathways and regulatory requirements.

We also face risks related to the manufacturing, supply chain, and distribution of investigational medicinal products, or IMPs, in Europe, which must comply with Good Manufacturing Practice, or GMP, requirements. Supply chain disruptions, import/export restrictions, or delays in obtaining trial materials could result in shortages at trial sites, delaying or interrupting our clinical trials.

Regulatory requirements in Europe may continue to evolve, including potential revisions to clinical trial regulations, pharmacovigilance obligations, and GMP standards, which could impose additional compliance burdens and increase costs. Failure to comply with any of these evolving requirements, obtain necessary approvals, or successfully complete clinical trials in Europe could delay or prevent the development of our product candidates and jeopardize our ability to obtain future regulatory approvals in the United States or other markets.

Failure to comply with European regulatory requirements at any stage could jeopardize our ability to obtain marketing approval, delay commercialization, or result in enforcement actions. Any such setbacks could materially impact our ability to bring our product candidates to market in Europe. Regulatory requirements for conducting clinical trials in Europe differ from those in the United States, and failure to comply with EU regulatory requirements could delay or prevent the development of INVA8001.

The regulatory framework governing clinical trials in the EU is complex and differs from that of the U.S. FDA. To conduct clinical trials in Europe, we must obtain approval through the CTA process. Any failure to comply with the applicable regulatory requirements, including Good Clinical Practice, or GCP guidelines, could result in delays, suspension, or termination of our planned Phase 2a trial, subject to regulatory clearance, of INVA8001 for chronic inducible urticaria in Europe.

Our ability to conduct trials in Europe may also be affected by differences in diagnostic criteria and regulatory expectations. The TempTest®, a CE-marked medical device, is used to determine a patient’s threshold temperature for chronic inducible urticaria. As a CE-marked medical device, TempTest® may be used as a diagnostic and trial assessment tool in a clinical trial in the EU. However, this device is not approved by the U.S. FDA, and U.S. physicians typically rely on clinical history for chronic inducible urticaria diagnosis. As a result, our reliance on EU regulatory approvals and diagnostic methods may not align with U.S. FDA expectations for future U.S. trials, potentially necessitating additional studies and delaying our development timeline.

Additionally, regulatory requirements may change during the course of our clinical development, requiring us to submit additional data, modify study designs, or conduct further preclinical or clinical evaluations. Approval policies and regulatory standards may vary among EU member states, further complicating our ability to initiate and complete clinical trials efficiently.

Even if we successfully submit a CTA to the competent authorities of the relevant EU member states there is no assurance that the results will be accepted by the EMA, and we may be required to conduct additional clinical trials. We intend to expand development into chronic spontaneous urticaria, prurigo nodularis and atopic dermatitis in the U.S. and globally upon successful completion of a Phase 2a trial, for which there can be no assurance as the outcome of a Phase 2a trial is inherently uncertain, and subject to future financing and us obtaining an IND clearance from the U.S. FDA. However, there is no guarantee that we will receive an IND approval or will be able to proceed with further clinical development in the U.S.

If we encounter delays in EU regulatory approvals, experience difficulties in aligning EU regulatory and U.S. FDA requirements, or fail to comply with evolving EU regulatory frameworks, we may be required to conduct additional clinical trials and our clinical development plans, business strategy, and financial condition could be materially adversely affected.

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The regulatory approval processes of the U.S. FDA, the European Commission and comparable foreign authorities are lengthy, time consuming, expensive and inherently unpredictable. If we are not able to obtain required regulatory approval for our product candidates, our business will be substantially harmed.

The time required to obtain approval or other marketing authorizations by the U.S. FDA, European Commission, which is the authorizing body for all centrally authorized medicinal products in the EU, which makes binding decisions based on the recommendations of the EMA, and comparable foreign authorities is unpredictable, and it 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, and 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. INVA8001 and INVA8003 are our only product candidates. INVA8001 is the only candidate that is currently positioned to commence clinical development, subject to clearance of a CTA by the competent authorities of the relevant European Union member states for chronic inducible urticaria. If this trial meets its clinical endpoints and receives regulatory clearance from the U.S. FDA, we intend to initiate clinical development for chronic spontaneous urticaria contingent on additional future financing. INVA8003 is our only other product candidate.

We have not obtained regulatory approval for any product candidate, and it is possible that we may never obtain regulatory approval for INVA8001, INVA8003 or any product candidates we may seek to develop in the future. Neither we nor any current or future collaborator is permitted to market any drug product candidates in the U.S. or EU until we receive regulatory approval of a new drug application, or NDA, from the U.S. FDA or a Marketing Authorization Application, or MAA, from the European Commission.

Prior to obtaining approval to commercialize any drug product candidate in the United States or abroad, we must demonstrate with substantial evidence from well-controlled clinical trials, to the satisfaction of the U.S. FDA or comparable foreign regulatory agencies that such product candidates are safe and effective for their intended uses. Results from preclinical studies and clinical trials can be interpreted in different ways. Even if we believe the preclinical or clinical data for our product candidates are promising, such data may not be sufficient to support approval by the U.S. FDA and other regulatory authorities. The U.S. FDA and other regulatory authorities may also require us to conduct additional preclinical studies or clinical trials for our product candidates either prior to or after approval, or it may object to elements of our clinical development programs.

Of the large number of products in development, only a small percentage successfully complete the U.S. FDA or foreign regulatory approval processes and are commercialized. The lengthy approval and marketing authorization process as well as the unpredictability of future clinical trial results may result in our failing to obtain regulatory approval and marketing authorization to market our product candidates, which would significantly harm our business, financial condition, results of operations and prospects.

We have invested a significant portion of our time and financial resources in the development of our product candidates, including INVA8001 and INVA8003. Our business is dependent on our ability to successfully complete preclinical and clinical development of, obtain regulatory approval for, and, if approved, successfully commercialize INVA8001, INVA8003 and any future product candidates in a timely manner.

Even if we eventually complete clinical testing and receive approval of a NDA or foreign marketing application for INVA8001, INVA8003 or any future product candidates, the U.S. FDA, European Commission or the applicable foreign regulatory agency may grant approval or other marketing authorization contingent on the performance of costly additional clinical trials, including post-marketing clinical trials. The U.S. FDA, European Commission or the applicable foreign regulatory agency also may approve or authorize for marketing a product candidate for a more limited indication or patient population than we originally request, and the U.S. FDA, European Commission or applicable foreign regulatory agency may not approve or authorize the labeling that we believe is necessary or desirable for the successful commercialization of a product candidate. Any delay in obtaining, or inability to obtain, applicable regulatory approval or other marketing authorization, or failure to obtain our desired product label, would delay or prevent commercialization of that product candidate and would materially adversely impact our business and prospects.

In addition, the U.S. FDA and other regulatory authorities may change their policies, issue additional regulations or revise existing regulations, or take other actions, which may prevent or delay approval of our future product candidates under development on a timely basis. Such policy or regulatory changes could impose additional

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requirements upon us that could delay our ability to obtain approvals, increase the costs of compliance or restrict our ability to maintain any marketing authorizations we may have obtained. Further, macroeconomic and other global conditions, have impacted and could in the future impact the ability of the U.S. FDA, European Commission and other regulatory authorities to provide any required approvals or marketing authorizations for our product candidates or result in the delay of such approvals or authorizations.

Preclinical and clinical product development involves a lengthy and expensive process, with an uncertain outcome.

Our assumptions about INVA8001’s development potential are based on the data generated from preclinical studies and clinical trials conducted by our licensor and our belief that INVA8001 will be shown to be effective if the design of clinical trials are changed in accordance with our plans. However, INVA8001 has previously failed to meet all endpoints in a Phase 2 clinical trial in atopic dermatitis conducted by our licensor, and it may fail to do so in our planned clinical trial in CIndU as well. We may also observe materially and adversely different safety results as we continue to conduct our clinical trials. INVA8003 was designed and optimized for its molecular structure and therapeutic potential using AI, as a targeted approach to inhibit the ASC dimerization process and protein-protein interaction specific to inflammasome assembly and believe it may offer a potentially better tolerated approach by avoiding binding pockets that are common across different proteins involved in normal human physiological functions, which were the target of prior attempts at designing NLRP3 inflammasome inhibitors, we will need to conduct lengthy and expensive preclinical studies and eventually clinical trials on INVA8003 and there can be no guarantee that we will achieve the results we anticipate.

In order to obtain regulatory approval to market a new drug product we must demonstrate proof of safety and efficacy in humans. It is impossible to predict when or if INVA8001 or INVA8003 will prove effective or safe in humans or will receive regulatory approval. Before obtaining marketing approval from regulatory authorities, including the U.S. FDA and European Commission for the sale of any product candidate, we must complete preclinical development and then conduct extensive clinical trials to demonstrate the safety, potency and efficacy of our product candidates in humans. Clinical testing is expensive, difficult to design and implement, can take many years to complete and is inherently uncertain as to outcome. A failure of one or more clinical trials can occur at any stage of testing or at any time during the trial process. The interim results of a clinical trial do not necessarily predict final results and the outcome of preclinical testing and early clinical trials may not be predictive of the results of later clinical trials as to safety or efficacy, particularly if later clinical trials have a materially different trial design. The historical failure rate for product candidates in our industry is high, particularly in the earlier stages of development. Moreover, preclinical and clinical data are often susceptible to varying interpretations and analyses, and many companies that have believed their product candidates performed satisfactorily in preclinical studies and clinical trials have nonetheless failed to obtain marketing approval of their products.

We have not completed any clinical trials required for the approval of any of our product candidates. We cannot assure you that any preclinical study or clinical trial that we are conducting, or may conduct in the future will demonstrate consistent or adequate efficacy and safety to obtain regulatory approval to market our product candidates.

In addition, our current U.S. clinical development plans involve the use of the TempTest®, a CE-marked medical device cleared for the market in the EU, which is used to determine a patient’s threshold temperature for chronic inducible urticaria; however, this device is not approved by the U.S. FDA and U.S. physicians typically rely on clinical history for chronic inducible urticaria diagnosis. As a result, our reliance on European regulatory approvals and diagnostic methods may not align with U.S. FDA expectations for future U.S. trials, potentially necessitating additional studies and delaying our development timeline.

We may incur additional costs and experience delays in completing, or ultimately be unable to complete, the development and commercialization of our product candidates.

Our current and planned clinical trials are expensive, time consuming, and subject to uncertainty. We cannot guarantee that any clinical trials will be conducted as planned or completed on schedule, if at all. We cannot be sure that submission of an IND or CTA will result in the applicable regulatory authorities allowing clinical trials to begin in a timely manner, if at all. Moreover, even if these trials begin, issues may arise that could suspend or terminate such clinical trials. A failure of one or more clinical trials can occur at any stage of testing, and our future clinical trials may not be successful.

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We may incur additional costs and experience delays in ongoing clinical trials for our product candidates, and we do not know whether future clinical trials, if any, will begin on time, need to be redesigned, enroll an adequate number of patients on time or be completed on schedule, if at all. We may experience numerous unforeseen events during or as a result of clinical trials that could delay or prevent our ability to receive marketing approval or commercialize our product candidates, including:

• regulators or institutional review boards not authorizing us or our investigators to commence a clinical trial or conduct a clinical trial at a prospective trial site;

• experiencing delays in reaching, or failing to reach, agreement on acceptable clinical trial contracts or clinical trial protocols with prospective trial sites or prospective CROs, the terms of which can be subject to extensive negotiation and may vary significantly among different CROs and trial sites;

• clinical trials of our product candidates producing negative or inconclusive results, including failure to demonstrate statistical significance, and we may decide, or regulators may require us, to conduct additional clinical trials or abandon product development programs;

• failing to demonstrate statistical significance in early stage or Phase 2 clinical trials of our product candidates, which may impact the timing and design of late stage clinical trials for such product candidates, or failing to demonstrate statistical significance in late stage trials despite promising early stage results;

• the number of patients required for clinical trials of our product candidates being larger than we anticipate, enrollment in these clinical trials being slower than we anticipate or participants dropping out of these clinical trials or failing to return for post-treatment follow-up at a higher rate than we anticipate;

• our product candidates having undesirable side effects or other unexpected characteristics, causing us or our investigators, regulators or institutional review boards to suspend or terminate the trials;

• our third-party contractors failing to comply with regulatory requirements or meet their contractual obligations to us in a timely manner, or at all;

• regulators or institutional review boards requiring that we or our investigators suspend or terminate clinical development for various reasons, including noncompliance with regulatory requirements or a finding that the participants are being exposed to unacceptable health risks;

• the cost of clinical trials of our product candidates being greater than we anticipate; and

• the supply or quality of our product candidates or other materials necessary to conduct clinical trials of our product candidates being insufficient or inadequate.

If we experience delays in the completion of, or termination of, any clinical trial of our product candidates, the approval and commercial prospects of our product candidates will be harmed, and our ability to generate product revenues from any of these product candidates will be delayed or eliminated. In addition, any delays in completing our clinical trials will increase our costs, slow down our product candidate development and approval process and jeopardize our ability to commence product sales and generate revenues.

If we are required to conduct additional clinical trials or other testing of our product candidates beyond those that we currently contemplate, if we are unable to successfully complete clinical trials of our product candidates or other testing, if the results of these trials or tests are not favorable or if there are safety concerns, we may, among other things:

• be delayed in obtaining marketing approval for our product candidates;

• not obtain marketing approval at all;

• obtain approval for indications or patient populations that are not as broad as intended or desired;

• obtain approval with labeling that includes significant use or distribution restrictions or safety warnings;

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• be subject to additional post-marketing testing requirements; or

• have the product removed from the market after obtaining marketing approval.

We have not yet initiated or completed testing of any product candidate in clinical trials. Success in preclinical studies or earlier clinical trials may not be indicative of results in future clinical trials.

Success in preclinical testing and early clinical trials does not ensure that later clinical trials will generate the same results or otherwise provide adequate data to demonstrate the efficacy and safety of a product candidate. Preclinical tests and Phase 1 and Phase 2 clinical trials are primarily designed to test safety, to study pharmacokinetics and pharmacodynamics and to understand the side effects of product candidates at various doses and dosing schedules. Success in preclinical or animal studies and early clinical trials does not ensure that later large-scale efficacy trials will be successful, nor does it predict final results. This is particularly the case with respect to INVA8001 because our planned clinical trials will be designed with significant differences relative to those conducted by Daiichi Sankyo to date. Our product candidates may fail to show the desired safety and efficacy in clinical development despite positive results in preclinical studies or having successfully advanced through initial clinical trials, whether conducted by us or third parties, particularly because, with respect to INVA8001, we anticipate significantly changing trial design for future clinical trials, and with respect to INVA8003, we are targeting a novel target that has not yet been tested in clinical trials. Further, INVA8001 and INVA8003 may fail to show the desired safety and efficacy in the treatment of chronic symptoms despite positive results in the treatment of acute symptoms.

Many companies in the pharmaceutical and biotechnology industries have suffered significant setbacks in late-stage clinical trials even after achieving promising results in preclinical testing and earlier-stage clinical trials. Such setbacks have occurred and may occur for many reasons, including: clinical sites and investigators may deviate from clinical trial protocols, whether due to lack of training or otherwise, and we may fail to detect any such deviations in a timely manner; patients may fail to adhere to any required clinical trial procedures, including any requirements for post-treatment follow-up; our product candidates may fail to demonstrate effectiveness or safety in certain patient subpopulations or at all; or our clinical trials may not adequately represent the patient populations we intend to treat, whether due to limitations in our trial designs or otherwise. Data obtained from preclinical and clinical activities are subject to varying interpretations, which may delay, limit or prevent regulatory approval. In addition, we may experience regulatory delays or rejections as a result of many factors, including changes in regulatory policy during the period of our product candidate development. Any such delays could negatively impact our business, financial condition, results of operations and prospects.

Interim, topline and preliminary results from our clinical trials that we announce or publish from time to time may change as more patient data becomes available and is 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 results from our preclinical studies and clinical trials, which are based on a preliminary analysis of then-available data. We also make assumptions, estimations, calculations and conclusions as part of our preliminary analyses of data, and we may not have received or had the opportunity to fully and carefully evaluate all data. As a result, the results and related findings and conclusions are subject to change following a more comprehensive review of the data related to the particular study or trial. Interim results 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 results 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. Differences between interim, top-line or preliminary data and final data could significantly harm our business prospects and may cause the trading price of our common stock to fluctuate significantly.

Further, others, including regulatory agencies, may not accept or agree with our assumptions, estimates, calculations, conclusions or analyses or may interpret or weigh the importance of data differently, which could impact the value of the particular program, the approvability or commercialization of the particular product candidate or product and our company in general. In addition, the information we choose to publicly disclose regarding a particular study or clinical trial is based on what is typically extensive information, and investors or

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others may not agree with what we determine is material or otherwise appropriate information to include in our disclosure. If the interim, topline or preliminary data that we report differ from actual results, or if others, including regulatory authorities, disagree with the conclusions reached, our ability to obtain approval for, and commercialize, our product candidates may be harmed, which could harm our business, operating results, prospects or financial condition.

As an organization, we are preparing to conduct, subject to regulatory approval, our first Phase 2a clinical trial, we have never conducted any clinical trials, and we may be unable to do so for any product candidates we may develop.

We will need to successfully complete pivotal clinical trials in order to obtain the approval of the European Commission, the U.S. FDA, MHRA or other regulatory authorities to market INVA8001, INVA8003 or any future product candidate. Carrying out pivotal clinical trials is a complicated process. As an organization, we are preparing to conduct, subject to regulatory approval, our first Phase 2a clinical trial and have not previously conducted any clinical trials, including later stage or pivotal ones. In order to do so, we will need to expand our clinical development and regulatory capabilities, and we may be unable to recruit and train, and subsequently retain, qualified personnel. We also expect to continue to rely on third parties to conduct our pivotal clinical trials. See “— Risks Related to our Dependence on Third Parties — We intend to rely on third parties to conduct a significant portion of our planned clinical trials and potential future clinical trials for product candidates, and those third parties may not perform satisfactorily, including failing to meet deadlines for the completion of such trials.” Consequently, we may be unable to successfully and efficiently execute and complete necessary clinical trials in a way that leads to a successful and timely NDA submission, or foreign marketing application and approval of INVA8001, INVA8003 or future product candidates. We may require more time and incur greater costs than our competitors and may not succeed in obtaining regulatory approvals of product candidates that we develop. Failure to commence or complete, or delays in, our planned clinical trials, could prevent us from or delay us in commercializing our product candidates.

Our preclinical studies and clinical trials may fail to demonstrate the safety and efficacy of our product candidates, or serious adverse or unacceptable side effects may be identified during the development of our product candidates, which could prevent or delay regulatory approval and commercialization, increase our costs or necessitate the abandonment or limitation of the development of some of our product candidates.

Before obtaining regulatory approvals for the commercial sale of our product candidates, we must demonstrate through lengthy, complex and expensive preclinical testing and clinical trials that our product candidates are safe and effective for use in each target indication, and failures can occur at any stage of testing. Clinical trials often fail to demonstrate safety or efficacy of the product candidate studied for the target indication.

If our product candidates are associated with adverse side effects in clinical trials or have characteristics that are unexpected, we may need to abandon their development or limit development to more narrow uses in which the side effects or other characteristics are less prevalent, less severe or more acceptable from a risk-benefit perspective. The U.S. FDA, European Commission, MHRA or other comparable foreign regulatory authority or an institutional review board may also require that we suspend, discontinue or limit our clinical trials based on safety information, or that we conduct additional animal or human studies regarding the safety and efficacy of our product candidates, which we have not planned or anticipated. Such findings could further result in regulatory authorities failing to provide marketing authorization for our product candidates or limiting the scope of the indication, if approved. Many product candidates that initially showed promise in early-stage testing have later been found to cause adverse side effects that prevented further development of the product candidate. We may observe different, more serious or more frequent adverse events in planned clinical trials of INVA8001 than was observed by Daiichi Sankyo in preclinical studies and clinical trials to date because we plan to re-design future clinical trials, including by testing higher and more frequent doses over a longer trial duration.

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

• regulatory authorities may withdraw, suspend or limit approvals of such product or seek an injunction against its manufacture or distribution;

• we may be required to recall a product;

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

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

• we may be required to change the way a product is distributed or administered, conduct additional clinical trials or change the labeling of a product or be required to conduct additional post-marketing studies or surveillance;

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

• sales of the product may decrease significantly or the product could become less competitive;

• we may not be able to achieve or maintain third-party payor coverage and adequate reimbursement; and

• our reputation and physician or patient acceptance of our products may suffer.

There can be no assurance that we will resolve any issues related to any product-related adverse events to the satisfaction of the U.S. FDA or comparable foreign regulatory agency in a timely manner or at all. Moreover, any of these events could prevent us from achieving or maintaining market acceptance of a particular product candidate, if approved, and could significantly harm our business, results of operations and prospects.

If we experience delays or difficulties in the enrollment and/or retention of patients in clinical trials, our receipt of necessary regulatory approvals could be delayed or prevented.

Successful and timely completion of clinical trials will require that we identify and enroll a sufficient number of patients. Patient enrollment, a significant factor in the timing of clinical trials, is affected by many factors, including the size and nature of the patient population and competition for patients with other trials. Trials may be subject to delays as a result of patient enrollment taking longer than anticipated or patient withdrawal. We may not be able to initiate or continue clinical trials for our product candidates if we are unable to locate and enroll a sufficient number of eligible patients to participate in these trials as required by the U.S. FDA or foreign regulatory authorities, or if a large number of patients withdraw. We cannot predict how successful we will be at enrolling subjects in future clinical trials. Subject enrollment is affected by other factors including:

• the eligibility criteria for the trial in question;

• the size of the patient population and process for identifying patients;

• the actual and perceived risks and benefits of the product candidate in the trial;

• the design of the trial;

• the ability to obtain and maintain informed consent;

• our ability to recruit clinical trial investigators with the appropriate competencies and experience;

• the availability of competing commercially available therapies and other competing candidates’ clinical trials;

• the willingness of patients to be enrolled in our clinical trials;

• the success of efforts to facilitate timely enrollment in clinical trials;

• the patient referral practices of physicians;

• the ability to monitor patients adequately during and after treatment; and

• the proximity and availability of clinical trial sites to prospective patients.

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Our inability to enroll a sufficient number of patients for clinical trials would result in significant delays and could require us to abandon one or more clinical trials altogether. Enrollment delays in these clinical trials may result in increased development costs for our product candidates, which would cause the value of our company to decline and limit our ability to obtain additional financing. Furthermore, we expect to rely on CROs and clinical trial sites to ensure the proper and timely conduct of our clinical trials and we will have limited influence over their performance.

Furthermore, even if we are able to enroll a sufficient number of patients for our clinical trials, we may have difficulty maintaining enrollment of such patients in our clinical trials. We cannot assure you that our assumptions used in determining expected clinical trial timelines are correct or that we will not experience delays or difficulties in enrollment, or be required by the competent authorities of the relevant EU member states, the U.S. FDA or other regulatory authority to increase our enrollment, which would result in the delay of completion of such trials beyond our expected timelines.

The results of clinical trials conducted at clinical trial sites outside the United States might not be accepted by the U.S. FDA, and data developed outside of a foreign jurisdiction similarly might not be accepted by such foreign regulatory authority.

Subject to the successful submission to, and acceptance by, the competent authorities of the relevant EU member states of a CTA, of which there can be no assurance, we plan to conduct clinical trials for INVA8001 in Europe. Although the U.S. FDA or comparable foreign regulatory authorities may accept data from clinical trials conducted outside the relevant jurisdiction, acceptance of these data is subject to certain conditions, if at all. In addition, there can be no guarantee that upon such submission these authorities will conclude that our current trial design is sufficient to commence clinical trials. As a result, our reliance on EU regulatory approvals and diagnostic methods may not align with U.S. FDA expectations for future U.S. trials, potentially necessitating additional studies and delaying our development timeline. For example, the U.S. FDA requires that the clinical trial must be well designed and conducted and performed by qualified investigators in accordance with ethical principles such as institutional review board or ethics committee approval and informed consent, the trial population must adequately represent the U.S. population and the data must be applicable to the U.S. population and U.S. medical practice in ways that the U.S. FDA deems clinically meaningful. Further, the U.S. FDA may consider an on-site inspection to be necessary in which case they must be able to validate the data through such an inspection or other appropriate means. In addition, while these clinical trials are subject to the applicable local laws, acceptance of the data by the U.S. FDA will be dependent upon its determination that the trials were conducted consistent with all applicable U.S. laws and regulations. There can be no assurance that the U.S. FDA will accept data from trials conducted outside of the United States as adequate support of a marketing application. Similarly, any data submitted to foreign regulatory authorities may not adhere to their standards and requirements for clinical trials and there can be no assurance a comparable foreign regulatory authority would accept data from trials conducted outside of its jurisdiction.

If the U.S. FDA or any comparable foreign regulatory authority does not accept such data, it would result in the need for additional trials, which could be costly and time-consuming, and which may result in current or future product candidates that we may develop not receiving approval for commercialization in the applicable jurisdiction. In addition, such foreign trials would be subject to the applicable local laws of the foreign jurisdictions where the trials are conducted, which may increase costs or time required to complete the clinical trial.

Conducting clinical trials outside the United States also exposes us to additional risks, including risks associated with:

• additional foreign regulatory requirements;

• foreign exchange fluctuations;

• compliance with foreign manufacturing, customs, shipment and storage requirements;

• inconsistent standards for reporting and evaluating clinical data and adverse events;

• any pandemic or public health concerns;

• diminished protection of intellectual property in some countries; and

• political instability, civil unrest, war or similar events that may jeopardize our ability to commence, conduct or complete a clinical trial and evaluate resulting data.

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Risk of Third-Party Diagnostic Device Dependency

Our clinical development strategy for chronic inducible urticaria (“CIndU”) depends on the availability and continued regulatory acceptance of the TempTest® device, a CE-marked medical diagnostic device that is manufactured by a third party, and the unavailability or regulatory non-acceptance of this device in the EU could materially and adversely affect the design, timing, and outcome of our clinical trials as we do not manufacture, control, or maintain regulatory responsibility for this device and must rely on third parties for its continued availability.

Our planned CIndU clinical trial in the EU will rely on the TempTest® device, a standardized provocation testing device used to identify, characterize, and assess treatment response in patients with CIndU. We have been informed that TempTest® is no longer being manufactured and that only limited quantities of previously produced CE-marked units remain available. The TempTest® devices still in the market have been CE-certified under the formerly applicable EU Directive on Medical Devices (MDD), but it is currently uncertain if the TempTest® will be re-certified under the currently applicable EU Regulation on Medical Devices (MDR). The TempTest® cannot be marketed under the applicable transition provisions, as they do not meet all requirements. Existing TempTest® devices in the supply chain that have already been placed on the market remain in the market as CE-marked devices. There can be no assurance that sufficient quantities of the TempTest® device will remain available for the duration of our planned or future clinical trials, or that existing devices will continue to be deemed acceptable by regulatory authorities for use in clinical studies.

If TempTest® devices become unavailable, are depleted, or are no longer acceptable for clinical or regulatory reasons, we may be required to amend our clinical trial protocols, adopt alternative diagnostic or provocation testing methodologies, utilize site-specific testing procedures, or seek additional regulatory guidance or approvals. Any such changes could introduce variability in patient selection or endpoint assessment, complicate comparisons across study sites or with historical data, increase clinical trial costs, delay trial initiation or completion, or adversely affect the interpretability, reliability, or regulatory acceptance of our clinical data.

Changes in methods of product candidate manufacturing or formulation may result in additional costs or delay.

As product candidates proceed through preclinical studies to late-stage clinical trials towards potential approval and commercialization, it is common that various aspects of the development program, such as manufacturing methods and formulation, are altered along the way in an effort to optimize processes and product characteristics. Such changes carry the risk that they will not achieve these intended objectives. Additionally, the methods and formulations used in our trials may differ from those used in earlier trials, which could impact comparability and overall outcomes. Any of these changes could cause our product candidates to perform differently and affect the results of planned clinical trials or other future clinical trials conducted with the materials manufactured using altered processes. Such changes may also require additional testing, regulatory notification or regulatory approval. This could delay completion of clinical trials, require the conduct of bridging clinical trials or the repetition of one or more clinical trials, increase clinical trial costs, delay approval of our product candidates and jeopardize our ability to commence sales and generate revenue.

We will be reliant on a non-exclusive license from AlphaMeld Corporation (a wholly owned subsidiary of InveniAI) to use its AlphaMeld Platform to monitor our target association network and increase our pipeline of product candidates. The AlphaMeld Platform may be licensed to our competitors. If this license is terminated, this could delay, prevent or impair our discovery and development of future product candidates.

We entered into the AlphaMeld License with InveniAI, pursuant to which we have a non-exclusive license for the use of InveniAI’s AlphaMeld Platform for a period of three years from January 1, 2024 (unless earlier terminated in accordance with the terms of the AlphaMeld License) with automatic renewals for additional one-year periods (unless terminated by either party with prior written notice). Pursuant to the amendment entered into on September 1, 2025, the annual subscription fee was reduced to $50,000 per annual subscription term effective January 1, 2024, payable following the successful completion of our initial public offering, at which time we will remit the total accrued fees of $0.1 million in accordance with mutually agreed payment timing. The AlphaMeld License, as amended, clarifies intellectual property ownership whereby we retain all rights to any inventions, data, know-how, or other intellectual property generated by us through use of the AlphaMeld Platform by our scientists, and AlphaMeld Corporation (InveniAI’s wholly owned subsidiary) will execute assignments to effect the transfer of such rights to us upon request without additional

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consideration. In addition, the September 1, 2025 amendment assigns all obligations of InveniAI under the agreement to AlphaMeld Corporation, a wholly owned subsidiary of InveniAI. AlphaMeld Corporation owns all intellectual property rights and assets necessary for the operation and commercialization of the AlphaMeld Platform. AlphaMeld Corporation consented to such assignment and agreed to assume all obligations of InveniAI under the agreement. We may terminate the AlphaMeld License upon 90 days prior written notice to AlphaMeld Corporation, either party may terminate the AlphaMeld License (i) in the event of an uncured breach of the license by the other party or (ii) if the other party becomes insolvent or bankrupt and AlphaMeld Corporation may terminate the AlphaMeld License in the event we breach the restrictions on our use of the AlphaMeld Platform contained in Section 2.6 of the AlphaMeld License, including permitting unauthorized access to the AlphaMeld Platform or using the AlphaMeld Platform in fields that we are restricted from under the non-compete agreement we entered into with InveniAI, Dr. Krishnan Nandabalan, BioXcel Therapeutics, Inc., or BioXcel Therapeutics, and certain of its affiliates, or the BioXcel entities. The AlphaMeld License gives us the right to access and use the AlphaMeld Platform to monitor our target association network in order to identify future product candidates. The AlphaMeld License, as amended on September 1, 2025, also clarifies IP ownership whereby we retain all rights to any inventions, data, know-how, or other IP generated by our use of AlphaMeld; upon request, InveniAI will execute assignments to effect transfer of such IP to us without additional consideration.

If the AlphaMeld License is terminated or if we are unable to enter into a new license on satisfactory terms or at all after the period of the AlphaMeld License expires, we would lose our rights to use the AI technology we are reliant on to monitor our target association network and discover and develop our product candidate pipeline, which in turn could have a material adverse effect on our business, financial condition, results of operations and prospects. In addition, because our license to use the AlphaMeld License is non-exclusive, AlphaMeld Corporation may choose to also license the AlphaMeld Platform to our competitors, some of whom have greater financial and other resources than we do, limiting or eliminating any product candidate identification advantage that we may have through the use of the AlphaMeld Platform.

We may not be successful in our efforts to increase our pipeline of product candidates by pursuing additional indications for our current product candidates or by in-licensing or acquiring additional product candidates for other diseases.

A key element of our strategy is to build and expand our pipeline of product candidates through our use of AlphaMeld Corporation’s (a wholly owned subsidiary of InveniAI) AlphaMeld Platform. Our use of the AI technology underlying the AlphaMeld Platform has not yet been validated and no product candidates identified by the AlphaMeld Platform have yet been successfully developed by us or any other company and approved by the U.S. FDA or any comparable regulatory authorities. We cannot assure you that our approach will work, nor can we assure you that any of these potential targets or other aspects of our platform will yield product candidates that could enter clinical development and, ultimately, be commercially valuable. The success of the AlphaMeld Platform in identifying viable product candidates that could enter clinical development and ultimately be commercially valuable depends on a number of factors, some of which are beyond our control, including the integrity, volume and continued access to data and our team’s ability to identify and appropriately test relevant hypotheses and identify the most promising product candidates. In addition, the non-compete agreement we, Dr. Nandabalan and InveniAI have entered into with BioXcel Therapeutics and certain of its affiliates restricts us from developing or commercializing product candidates in the fields of neuroscience and immuno-oncology, or the restricted field, subject to specified exceptions. Even if we identify promising potential product candidates outside the restricted field using AI or otherwise, our in-licensing or development efforts may be unsuccessful, in which case we may not be able to advance our drug discovery capabilities as quickly as we expect or expand our product pipeline as quickly as we desire.

Even if we successfully identify and develop or in-license additional product candidates, the potential product candidates that we identify, in-license or acquire may not be suitable for clinical development, including as a result of being shown to have harmful side effects or other characteristics that indicate that they are unlikely to be products that will receive marketing approval and/or achieve market acceptance. The development, approval and commercialization of such product candidates will be subject to the risks and uncertainties associated with drug development and sales, including those described herein.

In addition, the technology used by the AlphaMeld Platform is only protected as a trade secret, which affords only limited protection, and competitors, some of whom have greater financial and other resources than we do, may gain access to the AI technology we use or develop similar or better technologies, limiting or eliminating any product candidate identification advantage that we may have using the AlphaMeld Platform.

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We may expend our limited resources to pursue a particular product candidate or indication and fail to capitalize on product candidates or indications that may be more profitable or for which there is a greater likelihood of success.

Because we have limited financial and management resources, we focus on development programs and product candidates that we identify for specific indications. We are currently primarily focused on the development of INVA8001 and INVA8003 for certain indications. As a result, we may forego or delay pursuit of opportunities with other product candidates or for other indications for INVA8001 and INVA8003 that later prove to have greater commercial potential. Our resource allocation decisions may cause us to fail to capitalize on viable commercial products or profitable market opportunities. Our spending on current and future development programs and product candidates for specific indications may not yield any commercially viable products. If we do not accurately evaluate the commercial potential or target market for a particular product candidate, we may relinquish valuable rights to that product candidate through collaboration, licensing or other royalty arrangements in cases in which it would have been more advantageous for us to retain sole development and commercialization rights to such product candidate.

Inadequate funding for the U.S. FDA, the SEC and other government agencies, including from government shutdowns, or other disruptions to these agencies’ operations, could hinder their ability to hire and retain key leadership and other personnel, prevent new products and services from being developed or commercialized in a timely manner or otherwise prevent those agencies from performing normal business functions on which the operation of our business may rely, which could negatively impact our business.

The ability of the U.S. FDA to review and approve new products can be affected by a variety of factors, including government budget and funding levels, the ability to hire and retain key personnel and accept the payment of user fees, and statutory, regulatory and policy changes. Average review times at the agency have fluctuated in recent years as a result. In addition, government funding of CMS and other government agencies on which our operations may rely, including those that fund research and development activities, is subject to the political process, which is inherently fluid and unpredictable.

Disruptions at the U.S. FDA and other agencies may also slow the time necessary for new product candidates to be reviewed and/or approved by necessary government agencies, which would adversely affect our business. If a prolonged government shutdown occurs, it could significantly impact the ability of the U.S. FDA to timely review and process our regulatory submissions, which could have a material adverse effect on our business. Further, future government shutdowns could impact our ability to access the public markets and obtain necessary capital in order to properly capitalize and continue our operations.

Risks Related to the Commercialization of Our Product Candidates

Even if any of our product candidates receive marketing approval, they may fail to achieve the degree of market acceptance by physicians, patients, third-party payors and others in the medical community necessary for commercial success.

If any of our product candidates receive marketing approval, they may nonetheless fail to gain sufficient market acceptance by physicians, patients, third-party payors and others in the medical community, which will significantly drive commercial success. If our product candidates do not achieve an adequate level of acceptance, we may not generate significant revenue and we may not become profitable. Our efforts to educate the medical community and third-party payors regarding the benefits of any approved products, may require significant resources and we may never be successful.

The degree of market acceptance of our product candidates, if approved for commercial sale, will depend on a number of factors, including:

• the demonstrated efficacy, safety and potential advantages compared to alternative treatments;

• the indications for which our product candidates are approved;

• the timing of market introduction of the product candidate as well as competitive products;

• our ability to offer our products at competitive prices;

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

• product labeling or product insert requirements of the U.S. FDA or foreign regulatory authorities, including any limitations or warnings contained in a product’s approved labeling, including any black box warning;

• the availability of the approved product candidate for use as a combination therapy;

• the willingness of the target patient population to try our new treatments and of physicians to prescribe these treatments;

• our ability to hire and retain a sales force;

• the strength of marketing and distribution support;

• the availability of third-party coverage and adequate reimbursement for INVA8001, INVA8003 and any other product candidates, once approved;

• the willingness of patients to pay all, or a portion of, out-of-pocket costs associated with our products in the absence of sufficient third-party coverage and adequate reimbursement;

• the prevalence and severity of any side effects;

• any restrictions on the use of our products together with other medications, and

• potential product liability claims and unfavorable publicity related to the product.

If we are unable to establish sales, marketing and distribution capabilities for INVA8001, INVA8003 or any other product candidate that may receive regulatory approval, we may not be successful in commercializing those product candidates if and when they are approved.

We do not have sales, marketing or distribution infrastructure and have no experience as a company in commercializing products. To achieve commercial success for INVA8001, INVA8003 or any other product candidate for which we may obtain marketing approval, we will need to establish a sales and marketing organization with technical expertise and supporting distribution capabilities to commercialize each such product in major markets. In the future, for some products candidates and indications, we may choose to build a focused sales and marketing infrastructure to market in the United States, if and when they are approved. There are risks involved with establishing our own sales, marketing and distribution capabilities. For example, recruiting and training a sales force is expensive and time consuming and could delay any product launch. If the commercial launch of a product candidate 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.

There are significant risks involved in the building and managing of a sales organization. Factors that may inhibit our efforts to market our products on our own include:

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

• our inability to generate sufficient sales leads;

• the inability of sales personnel to obtain access to physicians in order to educate physicians about our product candidates, once approved;

• the lack of complementary products to be offered by sales personnel, which may put us at a competitive disadvantage relative to companies with more extensive product lines; and

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

If we are unable to establish our own sales, marketing and distribution capabilities and are forced to enter into arrangements with, and rely on, third parties to perform these services, our revenue and our profitability, if any, are likely to be lower than if we had developed such capabilities ourselves. In addition, we may not be successful in

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entering into arrangements with third parties to sell, market and distribute our product candidates or may be unable to do so on terms that are favorable to us. We likely will have little control over such third parties, and any of them may fail to devote the necessary resources and attention to sell and market our products effectively. If we do not establish sales, marketing and distribution capabilities successfully, either on our own or in collaboration with third parties, we will not be successful in commercializing our product candidates.

We face substantial competition, which may result in a smaller than expected commercial opportunity and/or others discovering, developing or commercializing products before or more successfully than we do.

The biotechnology and pharmaceutical industries, and particularly the market for the treatment of IMIDs, are characterized by rapidly advancing technologies, intense competition and a strong emphasis on proprietary and novel products and product candidates. We face competition with respect to our current product candidates and will face competition with respect to any product candidates that we may seek to develop or commercialize in the future, from many different sources, including major pharmaceutical and biotechnology companies, academic institutions, governmental agencies, consortiums and public and private research institutions.

With respect to chronic urticaria, we will face branded competition from omalizumab (XOLAIR), dupilumab (Dupixent) and remibrutinib (Rhapsido), and from a number of companies with product candidates in late-stage development for chronic urticaria, including Celldex, Evommune and Jasper, among others. Our commercial opportunity could be reduced or eliminated if our competitors develop and commercialize products that are safer or more effective, have fewer or less severe side effects, are more convenient or are less expensive than INVA8001, INVA8003 or any other product candidate that we may develop. Our competitors also may obtain U.S. FDA, European Commission, MHRA or other regulatory approval for their product candidates more rapidly than we may obtain approval for our product candidates, which could result in our competitors establishing a strong market position before we are able to enter the market. Competing products could present superior treatment alternatives and could render our product candidates obsolete or noncompetitive before we recover the expense of developing and commercializing our product candidates.

Many of the companies against which we are competing, or against which we may compete in the future, have significantly greater financial resources and expertise in research and development, manufacturing, preclinical testing, conducting clinical trials, obtaining regulatory approvals and marketing approved products than we do. Mergers and acquisitions in the pharmaceutical and biotechnology industries may result in even more resources being concentrated among a smaller number of our competitors. Smaller or early-stage companies may also prove to be significant competitors, particularly through collaborative arrangements with large and established companies. These competitors also compete with us in recruiting and retaining qualified scientific and management personnel and establishing clinical trial sites and patient registration for clinical trials, as well as in acquiring technologies complementary to, or that may be necessary for, our programs. If we are unable to compete effectively, our opportunity to generate revenue from the sale of our products we may develop, if approved, could be adversely affected.

Advancements in treatment paradigms and emerging technologies may limit the commercial viability of our product candidates.

The rapid pace of innovation in the biotechnology and pharmaceutical industries may lead to the development of novel treatment modalities, including next-generation biologics, small molecules, gene therapies, RNA-based therapeutics, and cell-based approaches, which could alter the standard of care for IMIDs, including chronic urticaria. If these advancements prove to be more effective, safer, more convenient, or more cost-efficient than our product candidates, our ability to establish and maintain a competitive market position may be significantly diminished.

Furthermore, breakthroughs in AI-driven drug discovery, precision medicine, and biomarker-based therapies could enable competitors to develop highly targeted and personalized treatments that may offer superior efficacy and fewer side effects compared to our product candidates. These evolving treatment paradigms may reduce physician and patient demand for traditional small-molecule inhibitors like INVA8001 and INVA8003, limiting their market potential.

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Additionally, new regulatory pathways and accelerated approval mechanisms may expedite the market entry of innovative therapies, allowing competitors to establish dominance before we can complete clinical development and obtain regulatory approval for our product candidates. If we fail to anticipate and adapt to these countervailing advancements, our ability to commercialize our therapies and achieve sustainable revenue growth may be materially and adversely affected.

The success of INVA8001, INVA8003 or any future product candidate, will depend significantly on coverage and adequate reimbursement or the willingness of patients to pay for these products.

We believe our success depends on obtaining and maintaining coverage and adequate reimbursement for INVA8001 and INVA8003 for any approved indications, and the extent to which patients will be willing to pay out-of-pocket for such product candidates, if approved, in the absence of reimbursement for all or part of the cost. Accordingly, we will need to establish a coverage and reimbursement strategy for any approved product candidate.

Additionally, in the United States, there is no uniform policy of coverage and reimbursement among third-party payors. Third-party payors often rely upon Medicare coverage policy and payment limitations in setting their own coverage and reimbursement policies. However, decisions regarding the extent of coverage and amount of reimbursement to be provided are made on a payor-by-payor basis. One payor’s determination to provide coverage for a drug product does not assure that other payors will also provide coverage, and adequate reimbursement. Third-party payors determine which products they will cover and establish reimbursement levels. There is significant uncertainty related to third-party payor coverage and reimbursement of newly approved products. In the United States, 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 will be covered. 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. Even if a third-party payor covers a particular product, the resulting reimbursement payment rates may not be adequate or may require co-payments that patients find unacceptably high. Reimbursement by a third-party payor may depend upon a number of factors, including the third-party payor’s determination that a product is safe, effective and medically necessary; appropriate for the specific patient; cost-effective; supported by peer-reviewed medical journals; included in clinical practice guidelines; and neither cosmetic, experimental nor investigational.

Increasingly, third-party payors are requiring that drug companies provide them with predetermined discounts from list prices and are challenging the prices charged for medical products. Further, such payors are increasingly challenging the price, examining the medical necessity and reviewing the cost effectiveness of medical product candidates. There may be especially significant delays in obtaining coverage and reimbursement for newly approved drugs. Third-party payors may limit coverage to specific product candidates on an approved list, known as a formulary, which might not include all U.S. FDA-approved drugs for a particular indication. We may need to conduct expensive pharmaco-economic studies to demonstrate the medical necessity and cost effectiveness of our products. Nonetheless, our product candidates may not be considered medically necessary or cost effective. We cannot be sure that coverage and reimbursement will be available for any product that we commercialize and, if reimbursement is available, what the level of reimbursement will be.

In addition, if we participate in the Medicaid Drug Rebate Program or other governmental pricing programs, in certain circumstances, our products would be subject to ceiling prices set by such programs, which could reduce the revenue we may generate from any such products. Participation in such programs would also expose us to the risk of significant civil monetary penalties, sanctions and fines should we be found to be in violation of any applicable obligations thereunder.

In the European Union, the pricing and reimbursement of pharmaceutical products are subject to national regulations, which vary significantly across member states. Even after obtaining a marketing authorization from the European Commission through a centralized procedure, or after obtaining national authorizations in member states through a decentralized procedure or mutual recognition procedure, we must still seek pricing and reimbursement approvals, negotiate reimbursement rates or otherwise ensure reimbursement of our products by public and private payers in the individual EU member states before being able to successfully commercialize our product candidates. Governments and health authorities in these markets employ various cost-containment measures, including price negotiations, international reference pricing, mandatory price reductions, and health technology assessments, or

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HTAs, to determine the cost-effectiveness of a drug before granting reimbursement. These measures can result in significant delays, restrictions on pricing, and uncertainty regarding the level of reimbursement, which may limit the commercial viability of our products in Europe. Foreign governments also have their own healthcare reimbursement systems, which vary significantly by country and region, and we cannot be sure that coverage and adequate reimbursement will be made available with respect to the treatments in which our products are used under any foreign reimbursement system. Outside the United States, international operations are generally subject to extensive governmental price controls and other market regulations, and we believe the increasing emphasis on cost-containment initiatives in Europe and elsewhere has and will continue to put pressure on the pricing and usage of our products candidates. 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 medicinal 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 products. Accordingly, in markets outside the United States, if we enter any, the reimbursement for our products may be reduced compared with the United States and may be insufficient to generate commercially reasonable revenue and profits.

Moreover, increasing efforts by governmental and third-party payors in the United States and abroad 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 products. We expect to experience pricing pressures in connection with the sale of any of our products due to the trend toward managed healthcare, the increasing influence of health maintenance organizations and additional legislative changes. The downward pressure on healthcare costs in general, and prescription drugs, surgical procedures and other treatments in particular, has become very intense. As a result, increasingly high barriers are being erected to the entry of new products.

There can be no assurance that INVA8001, INVA8003 or any other product candidate, if approved for sale in the United States or in other countries, will be considered medically reasonable and necessary, that it will be considered cost-effective by third-party payors, that coverage or an adequate level of reimbursement will be available or that reimbursement policies and practices in the United States and in foreign countries where our products are sold will not adversely affect our ability to sell our product candidates profitably.

The market for INVA8001, INVA8003 or any other product candidates may be smaller than we expect.

Our estimates of the potential market opportunity for INVA8001, INVA8003 or any other product candidates include several key assumptions, based on our industry knowledge, industry publications and third-party research reports. These assumptions include the number of patients who have the IMIDs we intend to target, as well as the estimated reimbursement levels for each product candidate, if approved.

While we believe our assumptions and the data underlying our estimates are reasonable, we have not independently verified the accuracy of the third-party data on which we have based our assumptions and estimates, and these assumptions and estimates may not be correct and the conditions supporting our assumptions or estimates may change at any time, including as a result of factors outside our control, thereby reducing the predictive accuracy of these underlying factors. Further, new studies may change the estimated incidence or prevalence of these diseases, and the potentially addressable patient population for our product candidates may not ultimately be amenable to treatment with our product candidates. If the actual market for INVA8001, INVA8003 or for any other product candidates we may develop is smaller than we expect, our revenues, if any, may be limited and it may be more difficult for us to achieve or maintain profitability.

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

We face an inherent risk of product liability exposure related to the testing of our product candidates in human clinical trials and will face an even greater risk if we commercially sell any products that we may develop, especially if our products are prescribed for off-label uses (even if we do not promote such uses). For example, we may be sued if our product candidates allegedly cause injury or are found to be otherwise unsuitable during product testing, manufacturing, marketing or sale. Any such product liability claims may include allegations of defects in manufacturing, defects in design, a failure to warn of dangers inherent in the product candidate, negligence, strict liability and a breach of warranties. Claims may be brought against us by clinical trial participants, patients or others

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using, administering or selling products that may be approved in the future. Claims could also be asserted under state consumer protection acts. If we cannot successfully defend ourselves against claims that our product candidates caused injuries, we will incur substantial liabilities. Regardless of merit or eventual outcome, liability claims may result in:

• decreased demand for any product candidates that we may develop;

• injury to our reputation and significant negative media attention;

• withdrawal of clinical trial participants;

• significant costs to defend the related litigation;

• substantial monetary awards paid to trial participants or patients;

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

• loss of revenue;

• reduced resources of our management to pursue our business strategy;

• the inability to commercialize any products that we may develop; and

• a decline in our stock price.

Although we intend to maintain product liability insurance coverage, such insurance may not be adequate to cover all liabilities that we may incur. We may need to increase our insurance coverage as we expand our clinical trials or if we commence commercialization of our product candidates. Insurance coverage is increasingly expensive. We may not be able to maintain insurance coverage at a reasonable cost or in an amount adequate to satisfy any liability that may arise.

Even if our product candidates receive regulatory and marketing approval, off-label use or misuse of our products may harm our reputation in the marketplace or result in injuries that lead to costly product liability suits, and our products may fail to achieve the degree of market acceptance by physicians, patients, healthcare payors and others in the medical community necessary for commercial success.

If our product candidates are approved by the U.S. FDA, European Commission or other regulatory agency we may only promote or market our product candidates for their specifically approved indications. We will train our marketing and sales force against promoting our product candidates for uses outside of the approved indications for use, known as “off-label uses,” but there can be no assurance that our training efforts will be successful. We cannot, in addition, prevent a physician from using our products off-label, when in the physician’s independent professional medical judgment he or she deems it appropriate. Furthermore, the use of our products for indications other than those approved by the U.S. FDA, European Commission or other regulatory agency may not effectively treat such conditions. Any such off-label use of our products could harm our reputation in the marketplace among physicians and patients. There may also be increased risk of injury to patients if physicians attempt to use our products for uses for which they are not approved, which could lead to product liability claims that might require significant financial and management resources and that could harm our reputation.

Further, if we are found to have promoted such off-label uses, we may become subject to significant liability. The U.S. federal government has levied large civil and criminal fines against companies for alleged improper promotion of off-label use and has enjoined several companies from engaging in off-label promotion. The government has also required companies to enter into consent decrees or imposed permanent injunctions under which specified promotional conduct is changed or curtailed. Similarly, in the EU, the promotion of off-label use is strictly prohibited, and violations could result in regulatory actions, fines, or other enforcement measures by national health authorities.

The commercial success of any of our product candidates will also depend upon the degree of market acceptance by physicians, patients, third-party payors and others in the medical community, for which there can be no assurance of. The degree of market acceptance of any product candidates we may develop, if approved for commercial sale, will depend on a number of factors, including the extent to which physicians will recommend our products to their patients. If any product candidates we develop do not achieve an adequate level of acceptance by physicians, healthcare payors, patients and the medical community, we will not be able to generate significant revenue and we may not become or remain profitable. The failure of any of our product candidates to find market acceptance would harm our business prospects.

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Risks Related to Our Dependence on Third Parties

We heavily rely on the exclusive license from Daiichi Sankyo to provide us with intellectual property rights to develop and commercialize INVA8001. If this license is terminated, we would lose our rights to develop and commercialize INVA8001.

Pursuant to the license agreement between InveniAI with Daiichi Sankyo, or as amended to date, the Daiichi Sankyo Agreement, as novated and assigned to us, we have, among other things, secured an exclusive, royalty-bearing license from Daiichi Sankyo for certain intellectual property and know-how relating to INVA8001 to commercialize INVA8001 for human uses. We and Daiichi Sankyo may terminate the Daiichi Sankyo Agreement in the case of the other party’s insolvency, or upon prior written notice within a specified time period for the other party’s material uncured breach, such as failure to make timely milestone or royalty payments. If the Daiichi Sankyo Agreement is terminated, we would lose our rights to develop and commercialize INVA8001, which in turn would have a material adverse effect on our business, financial condition, results of operations and prospects, including, but not limited to, cessation of our operations to the extent we are unable to develop other product candidates at the time of such termination.

We intend to rely on third parties to conduct a significant portion of our planned clinical trials and potential future clinical trials for product candidates, and those third parties may not perform satisfactorily, including failing to meet deadlines for the completion of such trials.

We intend to engage CROs to conduct our planned clinical trials of INVA8001 and INVA8003 and similarly expect to engage CROs for future clinical trials for INVA8001, INVA8003 or other product candidates that we may progress to clinical development. We expect to continue to rely on third parties, including clinical data management organizations, medical institutions and clinical investigators, to conduct those clinical trials. Any of these third parties may terminate their engagements with us, some in the event of an uncured material breach and some at any time for convenience. If any of our relationships with these third parties terminate, we may not be able to timely enter into arrangements with alternative third parties or to do so on commercially reasonable terms, if at all. Switching or adding CROs involves substantial cost and requires management time and focus. In addition, there is a natural transition period when a new CRO commences work. As a result, delays occur, which can materially impact our ability to meet our desired clinical development timelines. There can be no assurance that we will not encounter challenges or delays in our CRO relationships in the future or that these delays or challenges will not have a material adverse impact on our business, financial condition and prospects.

In addition, any third parties conducting our clinical trials will not be our employees, and except for remedies available to us under our agreements with such third parties, we cannot control whether or not they devote sufficient time and resources to our clinical programs. If these third parties do not successfully carry out their contractual duties or obligations or meet expected deadlines, if they need to be replaced or if the quality or accuracy of the clinical data they obtain is compromised due to the failure to adhere to our clinical protocols, regulatory requirements or for other reasons, our clinical trials may be extended, delayed or terminated and we may not be able to obtain regulatory approval for or successfully commercialize our product candidates. Consequently, our results of operations and the commercial prospects for our product candidates would be harmed, our costs could increase substantially and our ability to generate revenue could be delayed significantly. In addition, many of the third parties with whom we contract may also have relationships with other commercial entities, including our competitors, for whom they may also be conducting clinical trials or other development activities that could harm our competitive position.

We rely on these parties for execution of our preclinical studies and clinical trials, and generally do not control their activities. Our reliance on these third parties for research and development activities will reduce our control over these activities but will not relieve us of our responsibilities. For example, we will remain responsible for ensuring that each of our clinical trials is conducted in accordance with the general investigational plan and protocols for the trial. Moreover, U.S. and foreign law requires us to comply with GCPs for conducting, recording and reporting the results of clinical trials to assure that data and reported results are credible and accurate and that the rights, integrity and confidentiality of trial participants are protected. We also are required to register ongoing clinical trials and post the results of completed clinical trials on government-sponsored databases and/or clinical trial registries, within specified timeframes. Failure to do so can result in fines, adverse publicity and civil and criminal sanctions.

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If we or any of our CROs or other third parties, including trial sites, fail to comply with applicable GCPs, the clinical data generated in our clinical trials may be deemed unreliable and the U.S. FDA, European Commission/EMA or comparable foreign regulatory authorities may require us to perform additional clinical trials before approving our marketing applications. We cannot assure you that upon inspection by a given regulatory authority, such regulatory authority will determine that any of our clinical trials complies with GCP regulations. In addition, our clinical trials must be conducted with product produced under cGMP conditions. Our failure to comply with these regulations may require us to repeat clinical trials, which would delay the regulatory approval process.

In addition, anticipated principal investigators for our clinical trials have served and will continue to serve as scientific advisors or consultants to us from time to time and receive compensation in connection with such services. Under certain circumstances, we may be required to report some of these relationships to the U.S. FDA, EMA or other regulatory agency. The U.S. FDA, EMA or other regulatory agency may conclude that a financial relationship between us and a principal investigator has created a conflict of interest or otherwise affected interpretation of the data obtained in the trial. The U.S. FDA, EMA or other regulatory agency may therefore question the integrity of the data generated at the applicable clinical trial site and the utility of the clinical trial itself may be jeopardized. This could result in a delay in approval, or rejection, of our marketing applications by the U.S. FDA, European Commission or other regulatory agencies and may ultimately lead to the denial of marketing approval of INVA8001, INVA8003 or any other product candidates.

We also expect to rely on other third parties to store and distribute product supplies for our clinical trials. Any performance failure on the part of our distributors could delay clinical development or marketing approval of our product candidates or commercialization of our products, producing additional losses and depriving us of potential revenue.

We intend to contract with third parties for the manufacture of INVA8001 for clinical drug supply and expect to continue to do so for commercialization if approved by the relevant regulatory authorities. This reliance on third parties increases the risk that we will not have sufficient quantities of our product candidates or such quantities at an acceptable cost or quality, which could delay, prevent or impair our development or commercialization efforts.

We do not have any cGMP manufacturing facilities and have no plans to develop our own clinical or commercial-scale manufacturing capabilities. We currently rely, and expect to continue to rely, on third parties for the cGMP manufacture of INVA8001, INVA8003 and any other product candidates that we may pursue and related raw materials for clinical development. Any significant delay, in the supply of a product candidate or raw material components for an ongoing clinical trial, due to the need to replace a third-party CMO or the need to replace or further test a batch of our product candidates, could considerably delay the completion of our clinical trials.

We also expect to rely on third-party manufacturers or third-party collaborators for the manufacture of commercial supply of INVA8001, INVA8003 and any other product candidates for which we obtain marketing approval. The processes involved in manufacturing our product candidates are complex, expensive, highly regulated and subject to multiple risks. Even minor deviations from normal manufacturing processes could result in reduced production yields, product defects and other supply disruptions. The facilities used by our CMOs to manufacture our product candidates must be inspected by the U.S. FDA or other regulatory authorities after we submit our NDA or comparable marketing application to the U.S. FDA, European Commission or other regulatory authority. We do not have control over a supplier’s or manufacturer’s compliance with laws, regulations and applicable cGMP standards or similar regulatory requirements and other laws and regulations, such as those related to environmental health and safety matters. If our contract manufacturers cannot successfully manufacture material that conforms to our specifications and the strict regulatory requirements of applicable law or regulatory authorities such as the U.S. FDA, we may be unable to obtain regulatory approval of our marketing applications. In addition, we have no control over the ability of our contract manufacturers to maintain adequate quality control, quality assurance and qualified personnel. If the U.S. FDA or a comparable foreign regulatory authority finds deficiencies with or does not approve these facilities for the manufacture of our product candidates or if it withdraws any such approval in the future, we may need to find alternative manufacturing facilities, which would significantly impact our ability to develop, obtain regulatory approval for or market our product candidates, if approved.

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We may be unable to enter into any agreements with future third-party manufacturers or to do so on acceptable terms, which increases the risk of failing to timely obtain sufficient quantities of our product candidates, or obtain them at an acceptable cost. Even if we enter into such agreements, qualifying and validating such manufacturers may take a significant period of time and reliance on third-party manufacturers entails additional risks, including, but not limited to:

• reliance on the third party for regulatory compliance and quality assurance;

• the possible breach of the manufacturing agreement by the third party;

• failure to manufacture our product according to our specifications;

• failure to successfully increase the manufacturing capacity for any of our product candidates in a timely or cost-effective manner, or at all, and the incurrence of upfront scale-up costs prior to commercial approval;

• increased costs due to the imposition of new or increased tariffs on imports from countries where our manufacturers operate;

• the possible misappropriation of our proprietary information, including our trade secrets and know-how;

• the failure to obtain, in sufficient quantities or at all, and possible increase in costs for, the raw materials for our product candidates; and

• the possible termination or nonrenewal of any agreement by any third party at a time that is costly or inconvenient for us.

Our failure, or the failure of our third-party manufacturers, to comply with applicable regulations could result in sanctions being imposed on us, including clinical holds, fines, injunctions, civil penalties, delays, suspension or withdrawal of approvals, license revocation, seizures or recalls of product candidates or drugs, operating restrictions and criminal prosecutions, any of which could significantly and adversely affect supply of our products.

Our product candidates, and any drugs that we may develop, may compete with other product candidates and drugs for access to manufacturing facilities. The performance of our third-party manufacturers may also be interrupted by production shortages or other supply interruptions resulting from pandemics, epidemics, natural disasters or extreme weather, infrastructure failures, labor disruptions or other factors. There are no assurances we would be able to enter into similar commercial arrangements with other manufacturers that operate under cGMP regulations and that might be capable of manufacturing for us in a timely manner. Any performance failure on the part of our existing or future manufacturers could delay clinical development or marketing approval. In addition, our current and anticipated dependence upon others for the manufacture of our product candidates may adversely affect our future profit margins and our ability to commercialize any products that receive marketing approval on a timely and competitive basis.

We may seek collaborations, license agreements and other similar arrangements with third parties for the development or commercialization of our product candidates. If those arrangements are not successful, we may not be able to capitalize on the market potential of these product candidates.

We may seek third-party collaborators, joint ventures, license agreements and other similar arrangements for the development and commercialization of our product candidates, including for the commercialization of any of our product candidates that are approved for marketing outside the United States. Our likely collaborators for any such arrangements include regional and national pharmaceutical companies and biotechnology companies. If we enter into any such additional arrangements with any third parties, we will likely have limited control over the amount and timing of resources that our collaborators dedicate to the development or commercialization of our product candidates. Our ability to generate revenue from these arrangements will depend on our collaborators’ abilities to successfully perform the functions assigned to them in these arrangements. We cannot be certain that, following a collaboration, license or strategic transaction, we will achieve an economic benefit that justifies such transaction.

Collaborations involving our product candidates would pose the following risks to us:

• collaborators have significant discretion in determining the efforts and resources that they will apply to these collaborations;

• collaborators may not perform their obligations as expected, or at all;

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• we could grant exclusive rights to our collaborators that would prevent us from collaborating with others;

• collaborators may not pursue development and commercialization of any product candidates that achieve regulatory approval or may elect not to continue or renew development or commercialization programs based on clinical trial results, changes in the collaborators’ strategic focus or available funding, or external factors, such as an acquisition, that divert resources or create competing priorities;

• collaborators may delay clinical trials, provide insufficient funding for a clinical trial program, stop a clinical trial or abandon a product candidate, repeat or conduct new clinical trials or require a new formulation of a product candidate for clinical testing;

• collaborators could independently develop, or develop with third parties, products that compete directly or indirectly with our product candidates if the collaborators believe that competitive products are more likely to be successfully developed or can be commercialized under terms that are more economically attractive than ours;

• product candidates discovered in collaboration with us may be viewed by our collaborators as competitive with their own product candidates or drugs, which may cause collaborators to devote fewer resources to the commercialization of our product candidates;

• collaborators may be less willing to enter into collaboration agreements with us due to the requirements of our non-compete agreement which requires that, for a period of five years from the effective date of the agreement, parties to any collaboration agreement with us agree not to use the results of our research or services to develop or commercialize products in the fields of neurology or immuno-oncology, subject to specified exceptions;

• a collaborator with marketing and distribution rights to one or more of our product candidates that achieve regulatory approval may not commit sufficient resources to the marketing and distribution of such products;

• a collaborator’s sales and marketing activities or other operations may not be in compliance with applicable laws, resulting in civil or criminal proceedings;

• collaborators may not provide us with timely and accurate information regarding development, regulatory or commercialization status or results, which could adversely impact our ability to manage our own development efforts, accurately forecast financial results or provide timely information to our stockholders regarding our product candidates;

• we may be required to invest resources and attention into such collaborations, which could distract from other business objectives;

• disagreements with collaborators, including disagreements over proprietary rights, contract interpretation or the preferred course of development, might cause delays or termination of the research, development or commercialization of product candidates, might lead to additional responsibilities for us with respect to product candidates, or might result in litigation or arbitration, any of which would be time-consuming and expensive;

• collaborators may not properly maintain or defend our or their intellectual property rights or may use our or their proprietary information in such a way as to invite litigation that could jeopardize or invalidate such intellectual property or proprietary information or expose us to potential litigation;

• collaborators may infringe the intellectual property rights of third parties, which may expose us to litigation and potential liability; and

• collaborations may be terminated, including for the convenience of the collaborator and, if terminated, we could be required to raise additional capital to pursue further development or commercialization of the applicable product candidates.

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Collaboration agreements may not lead to development or commercialization of product candidates in the most efficient manner or at all. If any future collaborator of ours were to be involved in a business combination, the continued pursuit and emphasis on our product development or commercialization program could be delayed, diminished or terminated.

We face significant competition in seeking appropriate collaborators. Whether we reach a definitive agreement for any collaboration will depend, among other things, upon our assessment of the collaborator’s resources and expertise, the terms and conditions of the proposed collaboration and the proposed collaborator’s evaluation of a number of factors. Those factors may include the design or results of clinical trials, the likelihood of approval by the U.S. FDA or other regulatory agency, the potential market for the subject product candidate, the costs and complexities of manufacturing and delivering such product candidate to patients, the potential of competing products, the existence of uncertainty with respect to our ownership of technology, which can exist if there is a challenge to such ownership without regard to the merits of the challenge and industry and market conditions generally. The collaborator may also consider alternative product candidates or technologies for similar indications that may be available to collaborate on and whether such a collaboration could be more attractive than the one with us for our product candidate. Collaborations are complex and time-consuming to negotiate and document. In addition, there have been a significant number of recent business combinations among large pharmaceutical companies that have resulted in a reduced number of potential future collaborators.

We may not be able to negotiate collaborations on a timely basis, on acceptable terms, or at all. If we are unable to do so, we may have to curtail the development of any product candidate that we planned to collaborate on, reduce or delay its development program or one or more of our other development programs, delay its potential commercialization or reduce the scope of any sales or marketing activities, or increase our expenditures and undertake development or commercialization activities at our own expense. If we elect to increase our expenditures to fund development or commercialization activities on our own, we may need to obtain additional capital, which may not be available to us on acceptable terms or at all. If we do not have sufficient funds, we may not be able to further develop our product candidates or bring them to market and generate revenue, which could have a material adverse effect on our business, financial condition, results of operations and prospects.

Our reliance on third parties exposes us to risks related to key personnel outside of our direct control.

We depend on third-party CROs, contract manufacturing organizations, or CMOs, academic collaborators, and other strategic partners to support various aspects of our research, development, and manufacturing activities. The success of these partnerships is influenced by the expertise, availability, and decision-making of key personnel within these third parties, many of whom we do not directly employ or control.

If any key individuals at our third-party partners leave, become unavailable, or fail to perform their responsibilities effectively, our clinical development, regulatory submissions, and commercial manufacturing efforts could be disrupted. Additionally, we may not always be aware of critical personnel changes, internal challenges, or operational deficiencies within these organizations until they negatively impact our programs.

Moreover, there may be key personnel at these third-party entities whose roles and influence are not fully visible to us, and unforeseen changes in their involvement could have a material adverse effect on our ability to meet our development timelines, regulatory requirements, or commercial objectives. Additionally, any violation of an agreement with us, including those related to confidentiality, inter-company agreements, collaboration, licensing, development, or other strategic arrangements with Invea, could result in operational disruptions, financial losses, or legal disputes that adversely affect our business. If we are unable to mitigate these risks or establish contingency plans, our reliance on third parties could impair our ability to successfully advance and commercialize our product candidates.

Risks Related to Our Relationship with InveniAI

InveniAI will exercise significant influence on the direction of our business, and the concentrated ownership of our common stock will prevent you and other stockholders from significantly influencing significant decisions.

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economic interest and voting power of our outstanding common stock after this offering and approximately % of such interest and power if the underwriters’ option to purchase additional shares is exercised in full. As long as InveniAI beneficially controls a significant amount of the voting power of our outstanding common stock, it will generally be able to exercise significant influence of the outcome of all corporate actions requiring stockholder approval, including the election and removal of directors. If InveniAI continues to hold its shares of our common stock, it could remain a significant stockholder for an extended period of time or indefinitely. InveniAI’s influence on the direction of our business may further increase if it chooses to purchase our shares in the open market after this offering, or if it acts together with our Chief Executive Officer, who is also the Chief Executive Officer of InveniAI and to whom InveniAI’s ownership of our shares may be attributed. In addition, if InveniAI and our Chief Executive Officer, who is also the Chief Executive Officer of InveniAI, sell their shares of our company to the same third party in private transactions, we may become subject to the control of a presently unknown third party.

Approval of commercial terms between us and InveniAI does not preclude the possibility of stockholder litigation, including but not limited to derivative litigation nominally against InveniAI and against its directors and officers and also against us and our directors and officers.

The commercial terms of the InveniAI Shared Services Agreement and our asset contribution agreement with InveniAI, or the Contribution Agreement, have not been negotiated on behalf of InveniAI by persons consisting solely of disinterested InveniAI directors.

No assurance can be given that any stockholder of InveniAI will not claim in a lawsuit that such terms in fact are not in the best interests of InveniAI and its stockholders, that the directors and officers of InveniAI breached their fiduciary duties in connection with such agreements and that any disclosures by InveniAI to its stockholders regarding these agreements and the relationship between InveniAI and us did not satisfy applicable requirements. In any such instance, we and our directors and officers may also be named as defendants, and we would have to defend ourselves and our directors and officers. While we will seek indemnification from InveniAI against any damages or other costs, which could be substantial, no such right to indemnification has been agreed to and it may never be agreed to. Further, any such litigation, regardless of outcome, would be time-consuming and would divert focus and resources from the development of our product candidates and our business, including but not limited to possibly delaying our clinical trials due to our management having to spend time and attention on such litigation.

Following this offering, we will continue to depend on InveniAI to provide us with certain services for our business.

Prior to this offering, we have operated as a controlled subsidiary of InveniAI. Certain administrative services required by us for the operation of our business are currently provided by InveniAI, including the use of InveniAI’s office space, equipment, general administrative support, intellectual property prosecution and management and human infrastructure for research and development activity. Under the InveniAI Shared Services Agreement, InveniAI will continue to provide us with various services following the closing of the offering until December 31, 2025, with the option to extend for additional one year periods upon mutual agreement. We believe it is most efficient for InveniAI to provide these services for us to facilitate the efficient operation of our business as we transition to becoming an independent, public company. Upon termination of the InveniAI Shared Services Agreement, or if InveniAI does not or is unable to perform its obligations under the InveniAI Shared Services Agreement, or any successor agreement we may enter into, we will be required to provide these services ourselves or to obtain substitute arrangements with other third parties. We may be unable to provide these services because of financial or other constraints or be unable to implement substitute arrangements on a timely basis on terms that are favorable to us, or at all.

We exercise no control over the activities of InveniAI other than the contractual rights we have pursuant to the InveniAI Shared Services Agreement, the Contribution Agreement, the InveniAI Line of Credit and the AlphaMeld License. However, Dr. Krishnan Nandabalan is our CEO and a member of our Board of Directors and is also President, Chief Executive Officer and Director of InveniAI and of its wholly owned subsidiary, AlphaMeld Corporation. Because of our historical relationships, our reputation is also potentially tied to the reputation of InveniAI and other companies that are affiliated, or have historical relationships with, InveniAI, including BioXcel Therapeutics.

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Certain of our directors and our CEO are currently allocating a portion of their time to InveniAI or its subsidiaries, where they serve as employees, officers and/or directors, which reduces allocation of their time to managing our business and affairs and creates potential conflicts of interest.

Certain of our officers and directors are also serving as employees, officers and/or directors of InveniAI or its subsidiaries. For example, our CEO, President and Chairman of our Board, Krishnan Nandabalan, Ph.D., is also the President, Director, and CEO of InveniAI and of its wholly owned subsidiary, AlphaMeld Corporation. Furthermore, Jonathan Zalevsky Ph.D. and Demetrios Kydonieus, J.D., M.B.A. each serve as directors of InveniAI and AlphaMeld Corporation.

Our directors, and our CEO, may have fiduciary obligations associated with their roles at InveniAI and AlphaMeld Corporation that would interfere with their ability to devote time to our business and affairs and that could adversely affect our business, financial condition, results of operations and growth prospects. Krishnan Nandabalan, our Chief Executive Officer and Chairman of the Board, is expected to remain as President, Director and Chief Executive Officer of InveniAI and its wholly owned subsidiary, AlphaMeld Corporation. Following the completion of our initial public offering, we expect our CEO, Dr. Nandabalan, to spend a minimum of 40 hours a week on the business affairs and operations of Invea. However, this minimum is not required by the terms of his employment agreement and the actual time spent on our business affairs and operations may be less than we expect.

Roles of our directors and CEO at InveniAI could require significant time and attention. While currently, the allocation of our CEO and directors’ time between our company and InveniAI and its subsidiaries is and is expected to be reasonable and manageable, if in the future, we grow or otherwise require management to devote more time to our business affairs, our business operations may be impacted if they are unable to do so due to their roles at InveniAI. Conversely, if InveniAI grows or otherwise requires management to devote more time to its business affairs, our operations may be adversely impacted if our directors and executive officers elect to devote more time to InveniAI than to us. As a result, we may need to hire key employees or to expand our management team, which we may not be able to do as required, or the quality and timeliness of decisions related to our operations may be adversely impacted, any of which could have a material adverse effect on our business, financial condition and results of operations.

The management of and beneficial ownership in InveniAI by our CEO and several of our directors creates the appearance of conflicts of interest, and may create actual conflicts of interest.

Management and ownership by our CEO and several of our directors in InveniAI creates the appearance of conflicts of interest, and may create actual conflicts of interest when these individuals are faced with decisions that could have different implications for InveniAI than for us, including decisions that relate to the InveniAI Shared Services Agreement, the Contribution Agreement, the AlphaMeld License, and the InveniAI Line of Credit, as well as potential agreements relating to future product candidates and AI-related services or collaborations or transactions with third parties with whom we and InveniAI both have, or would like to have, business relationships. Pursuant to the terms of the InveniAI Shared Services Agreement, Dr. Nandabalan has agreed to recuse himself with respect to voting on any matter coming before either the board of InveniAI or our board of directors related to our relationship with InveniAI, although he will still be permitted to participate in discussions and negotiations. Any actual conflicts of interest may result in adverse outcomes to our business, and any perceived conflicts of interest resulting from investors questioning the independence of our management or the integrity of corporate governance procedures may materially affect our stock price.

Any disputes that arise between us and InveniAI with respect to our past and ongoing relationships could harm our business operations.

Disputes may arise between InveniAI and us in a number of areas relating to our past and ongoing relationships, including:

• intellectual property, technology, and business matters, including failure to make required technology transfers and failure to comply with non-compete provisions applicable to InveniAI and us;

• labor, tax, employee benefit, indemnification and other matters arising from the separation of Invea from InveniAI;

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• distribution and supply obligations;

• employee retention and recruiting;

• business combinations involving us;

• sales or distributions by InveniAI of all or any portion of its ownership interest in us;

• the nature, quality, and pricing of services InveniAI has agreed to provide us; and

• business opportunities that may be attractive to both InveniAI and us.

Assuming (i) an initial public offering price of $ per share, the midpoint of the price range set forth on the cover page of this prospectus, and (ii) that the number of shares offered by us, as set forth on the cover page of this prospectus, remains the same, subsequent to the offering InveniAI will own % of our outstanding common stock, and approximately % of such interest and power if the underwriters’ option to purchase additional shares is exercised in full, which may be further increased if InveniAI chooses to purchase our shares in the open market after this offering. As a result, InveniAI will be able to exercise significant influence over our operations and if any such disputes arise, we may not be able to pursue a line of business that we otherwise may want to.

We and our stockholders may not achieve some or all of the expected benefits of our separation from InveniAI.

Drug development is an expensive and time-consuming process. In order to realize the value proposition of Invea as a drug development company, we intend to target early-stage healthcare and pharmaceutical focused investors. In order to successfully attract this type of new investment, we separated from InveniAI, because we believe we will achieve some or all of the following benefits:

• improving strategic and operational flexibility, and streamlining decision-making by providing the flexibility to implement our strategic plan and to respond more effectively to different customer needs and the changing economic environment;

• allowing us to adopt the capital structure, investment policy and dividend policy best suited to our financial profile and business needs, without competing for capital with InveniAI’s other businesses;

• creating an independent equity structure that will facilitate our ability to affect future acquisitions utilizing our common stock; and

• facilitating incentive compensation arrangements for employees more directly tied to the performance of our business, and enhancing employee hiring and retention by, among other things, improving the alignment of management and employee incentives with performance and growth objectives of our business.

If we are not able to achieve the full strategic and financial benefits we expect to receive from the Separation, or if the benefits are delayed or do not occur at all, our business financial conditions and results of operations may be adversely affected. Even if we are able to achieve standalone, independent status as a drug development company, there can be no assurance that investors and analysts will place a greater value on us as a standalone drug development company than as a wholly-or substantially-owned subsidiary of InveniAI.

The assets and resources that we acquire from InveniAI in the Separation may not be sufficient for us to operate as an independent company, and we may experience difficulty in separating our assets, resources, and operations from InveniAI.

Because we have operated as an independent company for only a limited time in the past, we may have difficulty doing so in the future. In addition to the assets and services provided to us by InveniAI, we will need to acquire additional financial resources, assets, and resources to support our operations as an independent company. Additionally, we may also face difficulty in completing the separation of our resources and operations from InveniAI in connection with the Separation. For example, we may face difficulties hiring additional personnel to assist with administrative and technical functions and acquiring office and laboratory space for use in the ordinary course operations of our business. If we have difficulty operating as an independent company, fail to acquire assets or hire requisite personnel that we need to operate, or incur unexpected costs in separating our business from InveniAI’s business, our financial condition and results of operations will be adversely affected.

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You may have difficulty evaluating our business because we have no history as a separate company and our historical financial information may not be representative of our results as a separate company.

The historical financial information included in this prospectus does not necessarily reflect the financial condition, results of operations or cash flows that we would have achieved as a separate company during the periods presented or those that we will achieve in the future. Prior to the contribution of our assets from InveniAI, our research and development activities were conducted by InveniAI as part of its broader operations, rather than as an independent division or subsidiary. InveniAI also performed, and will continue to perform, various corporate functions relating to our business. Our historical financial information reflects allocations of corporate expenses from InveniAI for these and similar functions. We believe that these allocations are comparable to the expenses we would have incurred had we operated as a separate company, but our judgments and estimates in this regard may prove inaccurate and we may incur higher expenses as a separate company.

Risks Related to Our Intellectual Property

If we are unable to obtain, maintain and enforce intellectual property rights relating to any of our product candidates or technology, or if the scope of the protection obtained is not sufficiently broad, our competitors or other third parties could develop and commercialize products similar or identical to ours, our ability to successfully commercialize our product candidates may be adversely affected and we may not be able to compete effectively in our markets.

We rely upon a combination of patents, access to certain third-party trade secrets and confidentiality agreements to protect the intellectual property related to our product candidates. These legal measures afford only limited protection, and competitors or others may gain access to or use our intellectual property and proprietary information. Our success depends in large part on our ability to obtain and maintain patent and other intellectual property protection in the United States and in other countries with respect to our proprietary technology and product candidates.

We cannot predict whether the patent applications we currently or may in the future pursue will issue as patents in any particular jurisdiction or will provide sufficient protection against competitors or other third parties. Nor can we predict the outcome of any challenge by our competitors to the validity or enforceability of any such patents. We cannot offer any assurances that the breadth of our granted patents will be sufficient to stop a competitor from developing and commercializing a product, including a generic product that would be competitive with one or more of our product candidates. Furthermore, any successful challenge to these patents or any other patents owned by or licensed to us after patent issuance could deprive us of the competitive advantage necessary for the successful commercialization of any of our product candidates. Further, if we encounter delays in regulatory approvals, the period of time during which we could market a product candidate under patent protection could be reduced (unless we obtain a patent term extension corresponding to such delays).

Our ability to obtain and maintain valid and enforceable patents depends on our inventions being patentable in light of the prior art. Furthermore, publications of discoveries in the scientific literature often lag behind the actual discoveries, and patent applications in the United States and other jurisdictions are typically not published until 18 months after filing, or in some cases not at all. Therefore, we cannot be certain that we or our licensors were the first to invent the inventions claimed in any of our owned or licensed patents or pending patent applications, or that we or our licensors were the first to make the inventions claimed in those owned or licensed patents or pending patent applications, or that we or our licensors were the first to file for patent protection of such inventions. If a third party can establish that we or our licensors were not the first to make or the first to file for patent protection of such inventions, our owned or licensed patents and patent applications may not issue as patents and even if issued, may be challenged and invalidated or rendered unenforceable. Furthermore, even if a patent is granted, our competitors or other third parties may be able to circumvent the patent by developing similar or alternative technologies or products in a non-infringing manner which could materially adversely affect our business, financial condition, results of operations and prospects.

The patent prosecution process is expensive and time-consuming. We may not be able to prepare, file and prosecute all necessary or desirable patent applications at a commercially reasonable cost or in a timely manner or in all jurisdictions. It is also possible that we may fail to identify patentable aspects of inventions made in the course of development and commercialization activities before it is too late to obtain patent protection on them. Moreover, depending on the terms of any existing and future in-licenses to which we may become a party, we may not have the right to control the preparation, filing and prosecution of patent applications, or to maintain the patents, covering technology in-licensed from third parties.

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Therefore, these patents and patent applications may not be prosecuted and enforced in a manner consistent with the best interests of our business.

In addition to the protection provided by our patent portfolio, we rely on access to certain third-party trade secret protection as well as confidentiality agreements to protect proprietary know-how that is not amenable to patent protection. Although we generally require all of our employees to assign their inventions to us, and all of our employees, consultants, advisors and any third parties who have access to our proprietary know-how, information, or technology to enter into confidentiality agreements, certain employees may not have signed such agreements and we cannot provide any assurances that all such agreements have been duly executed, or that such trade secrets and other confidential proprietary information will not be disclosed. Moreover, our competitors may independently develop knowledge, methods and know-how equivalent to the above-mentioned trade secrets. Competitors could purchase our products, if approved, and replicate some or all of the competitive advantages we derive from our development efforts for technologies on which we do not have patent protection. If any trade secrets were to be lawfully obtained or independently developed by a competitor, we would have no right to prevent them, or those to whom they communicate it, from using that technology or information to compete with us. If any trade secrets were to be disclosed to or independently developed by a competitor, our competitive position would be harmed.

We also seek to preserve the integrity and confidentiality of our proprietary data and third-party trade secrets by maintaining physical security of our premises and physical and electronic security of our information technology systems. However, our agreements and security measures may be breached, and we may not have adequate remedies for any breach. Also, if the steps taken to maintain trade secrets are deemed inadequate, we may have insufficient recourse against third parties for misappropriating the trade secret. In addition, others may independently discover the trade secrets and our proprietary information. For example, regulatory agencies such as the U.S. FDA consider whether to make additional information publicly available on a routine basis, and it is not clear at the present time how the disclosure policies may change in the future. If we are unable to prevent material disclosure of the non-patented intellectual property related to our technologies to third parties, we may not be able to establish or maintain a competitive advantage in our market, which could materially adversely affect our business, results of operations and financial condition.

Patent terms may be inadequate to protect our competitive position on our products for an adequate amount of time, and if we do not obtain protection under the Hatch-Waxman Amendments and similar non-U.S. legislation for extending the term of patents covering each of our product candidates, our business may be materially harmed.

Patents have a limited lifespan. In the United States, 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 additional patents covering our current or future product candidates 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 time required for development, testing, and regulatory review of new product candidates, patents protecting such candidates might expire before or shortly after commercialization.

For instance, the in-licensed U.S. patent covering INVA8001 is expected to expire in 2030, though we may be eligible for a patent term extension of up to five years. Additionally, we have in-licensed patents covering INVA8001 in Japan and countries within the European Patent Convention (Germany, France, and Great Britain), all of which have comparable expirations without extensions of patent term. A pending U.S. non-provisional patent application and a PCT application related to methods of use, new formulations, and combinations have also been filed, with potential patents arising from these applications expected to expire in 2043, subject to applicable fees and extensions. Furthermore, two provisional patent applications filed in 2024 cover certain dosing regimens, formulations, methods of use, and a synthesis route, with potential patents, if granted, expected to expire in 2045.

Depending upon the timing, duration, and conditions of U.S. FDA marketing approval of our product candidates, one or more of our U.S. patents, including those covering INVA8001, may be eligible for limited patent term extension under the Hatch-Waxman Amendments and similar legislation in the European Union. However, we may not receive an extension if we fail to apply within applicable deadlines, if the length of the extension granted is less than expected, or if we do not meet other regulatory requirements. If we are unable to obtain adequate patent term extensions or regulatory exclusivities such as orphan drug designation or new chemical entity status, our competitors may obtain approval to market competing products sooner. As a result, our revenue from applicable products could be reduced, potentially having a material adverse effect on our business.

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If we fail to comply with our obligations in any current intellectual property licenses with third parties, or fail to obtain such licenses in the future, we could lose rights that are material to our business.

We have licensed third-party intellectual property that is material to our business, and may enter into additional licenses in the future. We do not and will not own the patents or patent applications that underlie these licenses, and we may not control either the prosecution or the enforcement of the patents. Under such circumstances, we may be forced to rely upon our licensors to properly prosecute and file those patent applications and prevent infringement of those patents. Therefore, we cannot be certain that the prosecution, maintenance and enforcement of these patent rights will be in a manner consistent with the best interests of our business.

If we or our licensors fail to maintain such patents, or if we or our licensors lose rights to those patents or patent applications, the rights we have licensed may be reduced or eliminated and our right to develop and commercialize any of our product candidates that are the subject of such licensed rights could be adversely affected.

Our rights to use technologies and practice the inventions claimed in the licensed patents and patent applications are subject to our licensors abiding by the terms of those licenses and not terminating them. In addition, existing license agreements do, and future agreements may, impose diligence, development and commercialization timelines and milestone payment, royalty, insurance and other obligations on us. If we fail to comply with our obligations, our licensors may have the right to terminate the licenses, in which event we might not be able to develop, manufacture or market any product that is covered by the intellectual property we in-license from such licensor and may face other penalties. If any of our licenses are terminated, we may lose our patent rights on a territory-by-territory basis, and such rights may be lost worldwide. Termination of any license agreement could reduce or eliminate our rights under these agreements and may result in our having to negotiate new or reinstated agreements with less favorable terms or cause us to lose our rights under these agreements, including our rights to important intellectual property or technology. Any of the foregoing outcomes could prevent us from commercializing relevant product candidates, which could have a material adverse effect on our operating results and overall financial condition.

In addition, disputes regarding obligations in licenses may require us to take expensive and time-consuming legal action to resolve, and, even if we are successful, may delay our ability to commercialize products and generate revenue. Further, if we are unable to resolve license issues that arise, we may lose rights to practice intellectual property that is required to make, use, or sell products. We may require additional licenses in the future. Licenses to additional third-party technology and materials that may be required for our development programs may not be available on commercially reasonable terms, or at all. The licensing or acquisition of third-party intellectual property rights is a competitive area, and several more-established companies may pursue strategies to license or acquire third-party intellectual property rights that we may consider attractive or necessary. These established companies may have a competitive advantage over us due to their size, capital resources and greater clinical development and commercialization capabilities. In addition, companies that perceive us to be a competitor may be unwilling to assign or license rights to us.

If we are unable to successfully obtain rights to required third-party intellectual property rights, we may have to abandon development of the relevant program or product candidate or expend time and resources re-designing the program or product candidate, which could have a material adverse effect on our business.

In addition, intellectual property rights that we in-license in the future may be granted through sublicenses under intellectual property owned by third parties, in some cases through multiple tiers. The actions of our licensors may therefore affect our rights to use our sublicensed intellectual property, even if we are in compliance with all of the obligations under our license agreements. Should our licensors or any of the upstream licensors fail to comply with their obligations under the agreements pursuant to which they obtain the rights that are sublicensed to us, or should such agreements be terminated or amended, our ability to develop and commercialize our product candidates may be materially harmed.

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Patent reform legislation could increase the uncertainties and costs surrounding the prosecution of our patent applications and the enforcement or defense of any future patents we obtain.

Our ability to obtain patents is highly uncertain because, to date, some legal principles remain unresolved, and there has not been a consistent policy regarding the breadth or interpretation of claims allowed in patents in the United States. Furthermore, the specific content of patents and patent applications that are necessary to support and interpret patent claims is highly uncertain due to the complex nature of the relevant legal, scientific, and factual issues. Changes in either patent laws or interpretations of patent laws in the United States and other countries may diminish the value of our intellectual property or narrow the scope of our patent protection.

Patent reform legislation in the United States and other countries, including the Leahy-Smith America Invents Act, or the Leahy-Smith Act, signed into law on September 16, 2011, and its implementation could increase the uncertainties around patent protection, costs, and the enforcement or defense of our patents, all of which could have a material adverse effect on our business, financial condition, results of operations, and prospects. The Leahy-Smith Act included a number of significant changes to U.S. patent law. Such provisions affect the way patent applications are prosecuted, redefine prior art, and provide more efficient and cost-effective avenues for competitors to challenge the validity of patents. The U.S. Patent and Trademark Office, or the USPTO, has developed regulations and procedures to govern the full implementation of the Leahy-Smith Act. An important change introduced by the Leahy-Smith Act is that, as of March 16, 2013, the United States 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 USPTO 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. We may not be able to promptly file patent applications on our inventions and even if we do file promptly, filing our patent applications earlier in our development process may result in less complete applications, and patents that issue from them may be more vulnerable to invalidation. Any such failure to achieve adequate patent protection or any such successful challenge to our issued patents could reduce our ability to exclude competitors and harm our business, financial condition, results of operations, and prospects.

The Leahy-Smith Act also limited where a patentee may file a patent infringement suit and introduced procedures making it easier for third parties to challenge issued patents, as well as to intervene in the prosecution of patent applications. Because of a lower evidentiary standard in USPTO 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 USPTO proceeding sufficient for the USPTO 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.

Finally, the Leahy-Smith Act contained new statutory provisions that require the USPTO to issue new regulations for their implementation, and it may take the courts years to interpret the provisions of the statute. We cannot predict what, if any, impact the Leahy-Smith Act will have on the operation of our business and the protection and enforcement of our intellectual property. However, the Leahy-Smith Act and its implementation could increase the uncertainties and costs surrounding the prosecution of our patent applications and the enforcement or defense of any patents we obtain.

Further, 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 actions by the U.S. Congress, the federal courts and the USPTO, the laws and regulations governing patents could change in unpredictable ways that would weaken our ability to obtain new patents or to enforce patents that we have owned or licensed or that we might obtain in the future. An inability to obtain, enforce, and defend patents covering our proprietary technologies would materially and adversely affect our business prospects and financial condition.

Similarly, in the European Union, patent laws and regulations continue to evolve, introducing additional complexities and uncertainties in obtaining and enforcing patent rights. The European patent system follows a different framework than the United States, including stricter limitations on amendments during prosecution and varying national enforcement mechanisms. The establishment of the Unified Patent Court (UPC) and the Unitary Patent system aims to streamline patent litigation across multiple EU member states, but uncertainties remain regarding its long-term impact on patent enforcement and validity challenges. Additionally, changes in European patent laws, judicial interpretations, or national regulations could diminish the value of our intellectual property and affect our ability to protect our product candidates in Europe

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Similarly, changes in patent laws and regulations in other countries or jurisdictions, changes in the governmental bodies that enforce them or changes in how the relevant governmental authority enforces patent laws or regulations may weaken our ability to obtain new patents or to enforce patents that we may obtain in the future. Further, the laws of some foreign countries do not protect proprietary rights to the same extent or in the same manner as the laws of the United States. As a result, we may encounter significant problems in protecting and defending our intellectual property both in the United States and abroad. For example, if the issuance in a given country of a patent covering an invention is not followed by the issuance in other countries of patents covering the same invention, or if any judicial interpretation of the validity, enforceability or scope of the claims or the written description or enablement, in a patent issued in one country is not similar to the interpretation given to the corresponding patent issued in another country, our ability to protect our intellectual property in those countries may be limited. 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. Changes in patent law and regulations in other countries or jurisdictions or changes in the governmental bodies that enforce them or changes in how the relevant governmental authority enforces patent laws or regulations may weaken our ability to obtain new patents or to enforce patents that we have licensed or that we may obtain in the future. Changes in either patent laws or in interpretations of patent laws in the United States and other countries may also materially diminish the value of our intellectual property or narrow the scope of our patent protection.

We may be involved in lawsuits to protect or enforce our patents, which could be expensive, time consuming, and unsuccessful.

While we are not currently involved in any disputes relating to our intellectual property, competitors may infringe the patents we have applied for. To counter infringement or unauthorized use, we may be required to file infringement claims, which can be expensive and time-consuming. If we initiate legal proceedings against a third party to enforce a patent covering one of our product candidates, the defendant could counterclaim that the patent covering our product or product candidate is invalid and/or unenforceable. In patent litigation in the United States, counterclaims alleging invalidity and/or unenforceability are common, and there are numerous grounds upon which a third party can assert invalidity or unenforceability of a patent.

In an infringement proceeding, a court may decide that the patent claims we are asserting are invalid and/or unenforceable, or may refuse to stop the other party from using the technology at issue on the grounds that our patent claims do not cover the technology in question. Third parties may also raise similar claims before administrative bodies in the United States or abroad, even outside the context of litigation.

Such mechanisms include re-examination, post grant review, inter partes review and equivalent proceedings in foreign jurisdictions (for example, opposition proceedings). Such proceedings could result in revocation of or amendment to our patents in such a way that they no longer cover our product candidates. The outcome following legal assertions of infringement, invalidity and unenforceability is unpredictable. With respect to the validity question, for example, we cannot be certain that there is no invalidating prior art, of which we, our patent counsel, and the patent examiner were unaware during prosecution. If a defendant were to prevail on a legal assertion of invalidity and/or unenforceability, we would lose at least part, and perhaps all, of the patent protection on our product candidates. An adverse result in any litigation or defense proceedings could put one or more of our patents at risk of being invalidated or interpreted narrowly, could put our patent applications at risk of not issuing and could have a material adverse impact on our business.

Our defense of litigation or interference proceedings may fail and require us to cease using certain intellectual property or force us to take a license under the intellectual property rights of the prevailing party, if available. Even if successful, litigation or interference proceedings may result in substantial costs and distract our management and other employees. We may not be able to prevent misappropriation of our intellectual property rights, particularly in countries where the laws may not protect those rights as fully as in the United States.

Furthermore, because of the substantial amount of discovery required in connection with intellectual property litigation, there is a risk that some of our confidential information could be compromised by disclosure during this type of litigation. There could also be public announcements of the results of hearings, motions, or other interim proceedings or developments. If securities analysts or investors perceive these results to be negative, it could have a material adverse effect on the price of our common stock.

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Third parties may initiate legal proceedings alleging that we are infringing their intellectual property rights, the outcome of which would be uncertain.

While no third parties to our knowledge have initiated legal proceedings against us to date, as our current and future product candidates progress toward commercialization, the possibility of a patent infringement claim against us increases. We cannot provide any assurance that our current and future product candidates do not infringe other parties’ patents or other proprietary rights, and competitors or other parties may assert that we infringe their proprietary rights in any event. We may become party to, or threatened with, adversarial proceedings or litigation regarding intellectual property rights with respect to our current and future product candidates, including infringement, interference or derivation proceedings, post-grant review and inter partes review before the USPTO or similar adversarial proceedings or litigation in other jurisdictions. Even if we believe such claims are without merit, a court of competent jurisdiction could hold that these third-party patents are valid, enforceable and infringed, which could have a negative impact on our ability to commercialize INVA8001, INVA8003 or any future product candidates. In order to successfully challenge the validity of any such U.S. patent in federal court, we would need to overcome a presumption of validity. As this burden is high and requires us to present clear and convincing evidence as to the invalidity of any such U.S. patent claim, there is no assurance that a court of competent jurisdiction would agree with us and invalidate the claims of any such U.S. patent. Similarly, the burdens on us to invalidate patent claims in foreign jurisdiction may vary substantially and courts in those jurisdictions may not agree with us that the claims are invalid. The outcome of proceedings involving assertions of infringement, invalidity and unenforceability during patent litigation is unpredictable. Furthermore, if a patent holder believes that one of our product candidates infringes its patent, the patent holder may sue us even if we have received patent protection for our technology. Moreover, we may face patent infringement claims from non-practicing entities that have no relevant revenue and against whom our own patent portfolio may thus have no deterrent effect. If a patent infringement suit were threatened or brought against us, we could be forced to stop or delay manufacturing or sales of the drug or product candidate that is the subject of the actual or threatened suit. Moreover, given the vast number of patents in our field of technology, we cannot be certain that our current and future product candidates do not or will not infringe existing patents or that we will not infringe patents that may be granted in the future.

If we are found to infringe a third party’s intellectual property rights, we could be required to obtain a license from such third party to continue commercializing our product candidates. However, we may not be able to obtain any required license on commercially reasonable terms or at all. Even if a license can be obtained on acceptable terms, the rights may be non-exclusive, which could give our competitors access to the same technology or intellectual property rights licensed to us. If we fail to obtain a required license, we may be unable to effectively market product candidates based on our technology, which could limit our ability to generate revenue or achieve profitability and possibly prevent us from generating revenue sufficient to sustain our operations. Alternatively, we may need to redesign our products, which may be impossible or require substantial time and monetary expenditure. Under certain circumstances, we could be forced, including by court orders, to cease commercializing our product candidates. In addition, in any such proceeding or litigation, we could be found liable for substantial monetary damages, potentially including treble damages and attorneys’ fees, if we are found to have willfully infringed the patent at issue. A finding of infringement that prevents us from commercializing our product candidates, requires us to redesign our products, or forces us to cease some of our business operations could materially harm our business.

The cost to us in defending or initiating any litigation or other proceeding relating to patent or other proprietary rights, even if resolved in our favor, could be substantial, and litigation would divert our management’s attention. Some of our competitors may be able to sustain the costs of complex patent litigation more effectively than we can because they have substantially greater resources. Uncertainties resulting from the initiation and continuation of patent litigation or other proceedings could delay our research and development efforts and limit our ability to continue our operations.

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

We employ individuals who were previously employed at other biotechnology or biopharmaceutical companies. Although we try to ensure that our employees, consultants and advisors do not use the proprietary information, trade secrets, or know-how of others in their work for us, we may be subject to claims that we or our employees, consultants, or independent contractors have inadvertently or otherwise used or disclosed confidential information of our employees’ former employers or other third parties.

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Litigation may be necessary to defend against these claims. There is no guarantee of success in defending these claims, and even if we are successful, litigation could result in substantial cost and be a distraction to our management and other employees.

We may be subject to claims challenging the inventorship or ownership of our intellectual property, including any patents we obtain.

We or our licensors may be subject to claims that former employees, collaborators, or other third parties have an ownership interest in our patent applications, any patents we obtain, or other intellectual property. We may be subject to ownership disputes in the future arising, for example, from conflicting obligations of consultants or others who are involved in developing our product candidates. Although it is our policy to require our employees and contractors who may be involved in the conception or development of intellectual property to execute agreements assigning such intellectual property to us, we may be unsuccessful in executing such an agreement with each party who, in fact, conceives or develops intellectual property that we regard as our own, and we cannot be certain that our agreements with such parties will be upheld in the face of a potential challenge, or that they will not be breached, for which we may not have an adequate remedy. Litigation may be necessary to defend against these and other claims challenging inventorship or ownership. If we fail in defending any such claims, in addition to paying monetary damages, we may lose valuable intellectual property rights, such as exclusive ownership of, or right to use, valuable intellectual property. If we no longer own intellectual property rights that are required to commercialize and protect our products, we may need to obtain license to those rights, which may not be available on commercially reasonable terms, or at all. Such an outcome could have a material adverse effect on our business. Even if we are successful in defending against such claims, litigation could result in substantial costs and be a distraction to management and other employees. Any of the foregoing could have a material adverse effect on our business, financial condition, results of operations and prospects.

Reliance on third parties requires us to share trade secrets, which increases the possibility that trade secrets will be misappropriated or disclosed, and confidentiality agreements with employees and third parties may not adequately prevent disclosure of trade secrets and protect other proprietary information.

We rely on certain third-party trade secrets, technical know-how, proprietary information and other confidential information to protect our products and technology and as otherwise useful to our business. Monitoring unauthorized uses and disclosures of trade secrets and other confidential information is difficult, and we do not know whether the steps we have taken to protect our confidential intellectual property will be effective. We seek to protect our confidential information, in part, through confidentiality and non-disclosure agreements with our employees, consultants, collaborators, suppliers, and other parties. These agreements typically restrict the ability of our employees, consultants, advisors and third-party contractors to use or disclose our proprietary information or publish data potentially relating to our proprietary information. Despite our efforts to protect trade secrets, we may not be able to prevent the unauthorized disclosure or use of our technical know-how or other proprietary information by the parties to these agreements. There can be no assurance that these agreements will not be breached, including by disclosure of our confidential information. If any of the collaborators, scientific advisors, employees, contractors and consultants who are parties to these agreements breaches or violates the terms of any of these agreements, we may not have adequate remedies for any such breach or violation, and trade secret status could be lost as a result. We also cannot guarantee that we have entered into such agreements with each party that may have or have had access to our confidential information or proprietary technology and processes. Moreover, if confidential information that is licensed or disclosed to us by our partners, collaborators, or others is inadvertently disclosed or subject to a breach or violation, we may be liable to the owner of that confidential information. Monitoring unauthorized uses and disclosures is difficult, and we do not know whether the steps we have taken to protect our proprietary technologies will be effective.

If we rely on third parties to manufacture or commercialize our product candidates, or if we collaborate with additional third parties for the development of our product candidates, we must, at times, share proprietary information with them. We may also conduct joint research and development programs that may require us to share potential trade secrets under the terms of our research and development partnerships or similar agreements. Despite the contractual provisions employed when working with third parties, the need to share confidential information increases the risk that such potential trade secrets become known by our competitors, are inadvertently incorporated into the technology of others, or are disclosed or used in violation of these agreements. Given that our proprietary position is based, in part, on our know-how and other confidential information, a competitor’s discovery of such information or other unauthorized use or disclosure thereof could have an adverse effect on our business and results of operations.

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Enforcing a claim that a third party illegally obtained and is using trade secrets or proprietary information is expensive and time consuming, and the outcome is unpredictable. In addition, courts outside the U.S. are sometimes less willing to protect trade secrets and the enforceability of confidentiality or similar types of agreements may vary from jurisdiction to jurisdiction.

We may enjoy only limited geographical protection with respect to certain patents and we may not be able to protect our intellectual property rights throughout the world.

Filing and prosecuting patent applications and defending patents covering our product candidates in all countries throughout the world would be prohibitively expensive. Competitors may use our technologies in jurisdictions where we have not obtained patent protection to develop their own products and, further, may export otherwise infringing products to territories where we have patent protection, but enforcement rights are not as strong as that in the United States or Europe. These products may compete with our product candidates, and our and our licensors’ future patents or other intellectual property rights may not be effective or sufficient to prevent them from competing.

In addition, we may decide to abandon national and regional patent applications before they are granted. The examination of each national or regional patent application is an independent proceeding. As a result, patent applications in the same family may issue as patents in some jurisdictions, such as in the U.S., but may issue as patents with claims of different scope or may even be refused in other jurisdictions.

Furthermore, the requirements for patentability differ in certain jurisdictions and countries. Some countries do not grant claims directed to methods of treatment or have additional restrictions on the scope of method of treatment claims compared to the United States. Accordingly, depending on the country, the scope of patent protection may vary for the same product candidate or technology.

While we intend to protect our intellectual property rights in our expected significant markets, we cannot ensure that we will be able to initiate or maintain protection efforts in all such markets. Additionally, the prosecution of patent applications in other jurisdictions is often a longer process and patents may be granted at a later date than in the United States, potentially delaying our ability to assert such patents against competitors. Accordingly, our efforts to protect our intellectual property rights in such countries may be inadequate, which may have an adverse effect on our ability to successfully commercialize our product candidates in all of our expected significant foreign markets. If we encounter difficulties in protecting, or are otherwise precluded from effectively protecting, the intellectual property rights important for our business in such jurisdictions, the value of these rights may be diminished, and we may face additional competition in those jurisdictions.

The laws of some jurisdictions do not protect intellectual property rights to the same extent as the laws or rules and regulations in the United States and Europe, and many companies have encountered significant difficulties in protecting and defending such rights in such jurisdictions. The legal systems of certain countries, particularly certain developing countries, do not favor the enforcement of patents, trade secrets, and other intellectual property rights, which could make it difficult for us to stop the infringement of any patents we obtain or marketing of competing products in violation of our proprietary rights generally. Proceedings to enforce our patent rights in other jurisdictions, whether or not successful, could result in substantial costs and divert our efforts and attention from other aspects of our business, could put any patents we obtain at risk of being invalidated or interpreted narrowly and our patent applications at risk of not issuing as patents, and could 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, 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 from the intellectual property that we develop or license.

Some countries also have compulsory licensing laws under which a patent owner may be compelled to grant licenses to third parties. In addition, some countries limit the enforceability of patents against government agencies or government contractors. In those countries, the patent owner may have limited remedies, which could materially diminish the value of such patents. If we are forced to grant a license to third parties with respect to any patents relevant to our business, our competitive position may be impaired.

In Europe, a new unitary patent system took effect on June 1, 2023, which may significantly impact European patents, including those granted before the introduction of the new system. Under the new system, applicants can, upon grant of a patent, opt for that patent to become a unitary patent which will be subject to the jurisdiction of a new

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unitary patent court, or UPC. Patents granted before the implementation of the new system can be opted out of UPC jurisdiction, remaining as national patents in the UPC countries. Patents that remain under the jurisdiction of the UPC may be challenged in a single UPC-based revocation proceeding that, if successful, could invalidate the patent in all countries who are signatories to the UPC. Further, because the UPC is a new court system and there is no precedent for the court’s laws, there is increased uncertainty regarding the outcome of any patent litigation. We are unable to predict what impact the new patent regime may have on our ability to exclude competitors in the European market. In addition to changes in patents laws, geopolitical dynamics, such as Russia’s incursion into Ukraine, may also impact our ability to obtain and enforce patents in particular jurisdictions. If we are unable to obtain and enforce patents as needed in particular markets, our ability to exclude competitors in those markets may be reduced.

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

Periodic maintenance fees, renewal fees, annuity fees and various other government fees on patents and/or applications will be due to be paid to the USPTO and various government patent agencies outside of the U.S. over the lifetime of our patents and/or applications and any patent rights we may obtain or license in the future. Furthermore, the USPTO and various non-U.S. government patent agencies require compliance with several procedural, documentary, fee payment and other similar provisions during the patent application process.

In many cases, an inadvertent lapse of a patent or patent application can be cured by payment of a late fee or by other means in accordance with the applicable rules. There are situations, however, in which non-compliance can result in abandonment or lapse of the patents or patent applications, 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, non-payment of fees and failure to properly legalize and submit formal documents within prescribed time limits.

In the European Union, the European Patent Office (EPO) and national patent offices impose similar procedural and fee-related requirements. Failure to timely pay renewal fees or comply with formalities — such as validating a European patent in designated member states within required deadlines — may lead to the lapse or revocation of patent rights in those jurisdictions. Additionally, the implementation of the Unitary Patent system introduces new administrative requirements and deadlines that, if not properly managed, could impact our ability to maintain effective patent protection across multiple EU member states.

If we or our licensors fail to maintain the patents and patent applications covering our product candidates or if we or our licensors otherwise allow our patents or patent applications to be abandoned or lapse, our competitors might be able to enter the market, which would hurt our competitive position and could impair our ability to successfully commercialize our product candidates in any indication for which they are approved.

Any trademarks we have obtained or may obtain may be infringed or otherwise violated or successfully challenged. If our trademarks and trade names are not adequately protected, or if we are unable to obtain desired trademarks or trade names, then we may not be able to build brand name recognition in our markets of interest and our business may be adversely affected.

As of December 12, 2025, certain foreign trademark registrations on the name “INVEA” have been issued to us and a single U.S. trademark was allowed by the USPTO. In the U.S., we have not yet filed our statement of use for registration. Any further trademark applications we file may be rejected and registered trademarks may not be obtained, maintained or enforced. If we do not successfully register our trademarks, we may encounter difficulty in enforcing, or be unable to enforce, our trademark rights against third parties, which could adversely affect our business and our ability to effectively compete in the marketplace.

We have secured registered trademarks on the name “INVEA” in Great Britain and Japan. We have not, however, yet registered trademarks for any of our product candidates in any jurisdiction. Any trademark applications we file may be rejected and registered trademarks may not be obtained, maintained or enforced. If we do not successfully register our trademarks, we may encounter difficulty in enforcing, or be unable to enforce, our trademark rights against third parties, which could adversely affect our business and our ability to effectively compete in the marketplace.

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In addition, any proprietary name we propose to use with any of our product candidate in the United States may need to be approved by the U.S. FDA, regardless of whether we have registered, or applied to register, the proposed proprietary name as a trademark. The U.S. FDA typically conducts a review of proposed product names, including an evaluation of potential for confusion with other product names. If the U.S. FDA objects to any of our proposed proprietary product names, we may be required to expend significant additional resources in an effort to identify a suitable proprietary product name that would qualify under applicable trademark laws, not infringe the existing rights of third parties and be acceptable to the U.S. FDA.

Similarly, in the EU, the EMA oversees the approval of proprietary drug names to prevent confusion with existing medicines. Even if a trade name is registered as a trademark, EMA or national regulatory authorities may still reject its use in a given member state or the entire EU. Furthermore, the European Union Intellectual Property Office, or EUIPO, and national trademark offices provide third parties with opportunities to oppose trademark applications or seek the cancellation of registered trademarks. Failure to secure or maintain trademark protection in the EU could limit our ability to establish brand recognition in European markets and may require us to rebrand our products, resulting in additional costs and market confusion.

In addition, our unregistered trademarks or trade names may be challenged, infringed, circumvented or declared generic or determined to be infringing on, misappropriating or violating other marks. In the USPTO and in comparable agencies in many foreign jurisdictions, third parties are given an opportunity to oppose pending trademark applications and to seek to cancel registered trademarks.

Opposition or cancellation proceedings may be filed against our trademarks, and our trademark registrations may not survive such proceedings. In the event that our trademarks are successfully challenged, we could be forced to rebrand our drugs, which could result in loss of brand recognition and could require us to devote resources to advertising and marketing new brands. At times, competitors may adopt trade names or trademarks similar to ours, thereby impeding our ability to build brand identity and possibly leading to market confusion. Our competitors may also infringe or otherwise violate our trademarks and we may not have adequate resources to enforce our trademarks. We may not be able to protect our rights to our trademarks and trade names, which we need to build name recognition among potential collaborators or customers in our markets of interest. Any of the foregoing events may have a material adverse effect on our business.

Furthermore, in many countries, owning and maintaining a trademark registration may not provide an adequate defense against a subsequent infringement claim asserted by the owner of a senior trademark. Over the long term, if we are unable to successfully register our trademarks and trade names and establish name recognition based on our trademarks and trade names, then we may not be able to compete effectively, and our business may be adversely affected. Our efforts to enforce or protect our proprietary rights related to trademarks, trade names, domain names or other intellectual property may be ineffective and could result in substantial costs and diversion of resources and could adversely impact our financial condition or results of operations.

Intellectual property rights do not necessarily address all potential threats to our competitive advantage.

The degree of future protection afforded by our intellectual property rights is uncertain because intellectual property rights have limitations and may not adequately protect our business or permit us to maintain our competitive advantage. The following examples are illustrative:

• others may be able to make products that are similar to or otherwise competitive with our product candidates but that are not covered by the claims of our current or future patents;

• an in-license necessary for the manufacture, use, sale, offer for sale or importation of one or more of our product candidates may be terminated by the licensor;

• we or future collaborators might not have been the first to conceive and reduce to practice the inventions covered by the patents or patent applications that we own, license or will own or license;

• we or future collaborators might not have been the first to file patent applications covering certain of our inventions;

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• others may independently develop similar or alternative technologies or duplicate any of our technologies without infringing our intellectual property rights;

• it is possible that our pending patent applications will not lead to issued patents;

• issued patents that we own or in-license may be held invalid or unenforceable as a result of legal challenges by our competitors;

• issued patents that we own or in-license may not provide coverage for all aspects of our product candidates in all countries;

• our competitors might conduct research and development activities in countries where we do not have patent rights and then use the information learned from such activities to develop competitive products for sale in our major commercial markets;

• ownership of our patents or patent applications may be challenged by third parties;

• we may not develop additional proprietary technologies that are patentable; and

• the patents of third parties may have an adverse effect on our business.

Should any of these events occur, they could significantly harm our business, results of operations and prospects.

Risks Related to Legal and Regulatory Compliance Matters

Our relationships with customers, healthcare providers and third-party payors are subject, directly or indirectly, to federal, state and foreign healthcare fraud and abuse laws, false claims laws, and other healthcare laws and regulations. If we are unable to comply, or have not fully complied, with such laws, we could face substantial penalties.

Healthcare providers and third-party payors in the United States and elsewhere will play a primary role in the recommendation and prescription of any product candidates for which we obtain marketing approval. Our current and future arrangements with healthcare professionals, principal investigators, consultants, customers and third-party payors subject us to various federal, state and foreign fraud and abuse laws and other healthcare laws, including, without limitation, the federal Anti-Kickback Statute, the federal civil and criminal false claims laws and transparency laws, including the law commonly referred to as the Physician Payments Sunshine Act, and regulations promulgated under such laws, and equivalent and similar laws and regulations in other jurisdictions, as well as codes of conducts of associations we are or will become member to, or that are generally accepted standards in the sector, or, collectively, Anticorruption Provisions. These Anticorruption Provisions will impact, among other things, our clinical research, proposed sales, marketing and educational programs, and other interactions with healthcare professionals. The laws and Anticorruption Provisions that will affect our operations include, but are not limited to:

• the federal Anti-Kickback Statute, which prohibits, among other things, individuals or entities from knowingly and willfully soliciting, receiving, offering or paying any remuneration (including any kickback, bribe or rebate), directly or indirectly, overtly or covertly, in cash or in kind in return for, or to induce, either the referral of an individual, or the purchase, lease, order or arrangement for or recommendation of the purchase, lease, order or arrangement for any good, facility, item or service for which payment may be made, in whole or in part, under a federal healthcare program, such as the Medicare and Medicaid programs. The term “remuneration” has been broadly interpreted to include anything of value. Many states have enacted equivalent kickback laws that apply to either government-funded or private insurance. Although there are a number of statutory exceptions and regulatory safe harbors protecting some common activities from prosecution, the exceptions and safe harbors are drawn narrowly. Practices that involve remuneration that may be alleged to be intended to induce prescribing, purchases or recommendations may be subject to scrutiny if they do not qualify for an exception or safe harbor. A person does not need to have actual knowledge of this statute or specific intent to violate it in order to have committed a violation;

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• the federal civil and criminal false claims laws, including, without limitation, the civil False Claims Act, which can be enforced by private citizens through civil whistleblower or qui tam actions, and civil monetary penalty laws which prohibit, among other things, individuals or entities from knowingly presenting, or causing to be presented, claims for payment or approval from the federal government, including Medicare, Medicaid and other government payors, that are false or fraudulent or knowingly making, using or causing to be made or used a false record or statement material to a false or fraudulent claim or to avoid, decrease or conceal an obligation to pay money to the federal government. A claim includes “any request or demand” for money or property presented to the U.S. federal government. There are also federal administrative laws, such as the Civil Monetary Penalties Law, that apply to false claims to government programs. Many states have enacted equivalent false claims statutes. Several pharmaceutical and other healthcare companies have been prosecuted under these laws for, among other things, allegedly providing free product to customers with the expectation that the customers would bill federal programs for the product. Other companies have been prosecuted for causing false claims to be submitted because of the companies’ marketing of products for unapproved, and thus non-reimbursable, uses. In addition, the government may assert that a claim including items or services resulting from a violation of the federal Anti-Kickback Statute constitutes a false or fraudulent claim for purposes of the federal False Claims Act;

• the federal statutes prohibiting health care fraud impose 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 executing, or attempting to execute, a scheme to defraud any healthcare benefit program, including private third-party payors and knowingly and willfully falsifying, concealing or covering up a material fact or making any materially false, fictitious or fraudulent statement in connection with the delivery of or payment for healthcare benefits, items or services. Similar to the 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;

• the federal Health Insurance Portability and Accountability Act of 1996, or HIPAA, and its implementing regulations also impose obligations, including mandatory contractual terms, on “covered entities,” including certain healthcare providers, health plans, healthcare clearinghouses, and their respective “business associates” that create, receive, maintain or transmit protected health information for or on behalf of a covered entity as well as their covered subcontractors, with respect to safeguarding the privacy and security of protected health information. The U.S. Department of Health and Human Services, or HHS, Office for Civil Rights has authority to impose civil money penalties against covered entities and business associates for failure to comply with HIPAA’s requirements, which penalties presently may range from $141 to $2.13 million per each type of violation per year (with annual adjustments for inflation), depending on the culpability and knowledge of the covered entity or business associate. HIPAA also gives state attorneys general certain authority to bring civil actions on behalf of state residents for damages or injunctions in federal courts to enforce HIPAA. Other existing analogous state and foreign laws that govern the privacy and security of health information in some circumstances, many of which differ from each other in significant ways and often are not preempted by HIPAA and other federal laws, further complicating compliance efforts;

• HHS announced on December 27, 2024, and published in the Federal Register on January 6, 2025, a Notice of Proposed Rulemaking proposing extensive modifications to the HIPAA security regulations. The agency received thousands of proposed comments, and may adjust or clarify the rule as part of the rule making process. If finalized in a form similar to the proposed rule, these modifications and could entail significant additional compliance obligations and costs for HIPAA-regulated covered entities and business associates;

• the federal transparency laws, including the federal Physician Payments Sunshine Act, which requires certain manufacturers of drugs, medical devices, biologicals and medical supplies for which payment is available under Medicare, Medicaid or the Children’s Health Insurance Program, with specific exceptions, to report annually to the Centers for Medicare & Medicaid Services, or CMS, information

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related to payments or other “transfers of value” made during the previous year to physicians (defined to include doctors, dentists, optometrists, podiatrists and chiropractors), other health care professionals (such as physician assistants and nurse practitioners), and teaching hospitals, as well as information regarding ownership and investment interests held by physicians and their immediate family members). Several states have created similar disclosure laws and further regulate manufacturer interactions with physicians and other health care professionals; and

• state and foreign law equivalents of the above listed federal laws and regulations, including laws and regulations and business association codes of conduct in the European Union and its member states that impose similar or more stringent requirements. In the EU, interactions with healthcare professionals are regulated under national laws as well as industry codes of conduct, such as the European Federation of Pharmaceutical Industries and Associations, or EFPIA, Code of Practice, and similar codes by EU members states’ national associations which govern transparency and promotional activities. National Anticorruption Laws in the EU member states differ in the way they restrict the cooperation of the pharmaceutical industry with healthcare professionals and in the sanctions they impose in case of infringement. In many EU member states, including Germany, infringement of Anticorruption Laws can be a criminal offense. Additionally, the EU’s GDPR imposes strict requirements on the processing of personal data, including data collected during clinical trials, and non-compliance can result in significant financial penalties. Transparency laws in some EU member states, and transparency codes issued by business associations, also require pharmaceutical companies to publicly disclose payments and other transfers of value made to healthcare professionals and organizations, similar to the U.S. Sunshine Act but with country-specific variations in implementation.

Because of the breadth of these laws and the narrowness of the statutory exceptions and regulatory safe harbors available, it is possible that some of our business activities could be subject to challenge under one or more of such laws. It is possible that governmental authorities will conclude that our business practices do not comply with current or future statutes, regulations 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 these laws or any other governmental regulations that may apply to us, we may be subject to significant penalties, including, without limitation, civil, criminal and administrative penalties, damages, fines, disgorgement, imprisonment, exclusion from participating in federal and state funded healthcare programs, such as Medicare and Medicaid or similar health insurance programs in other countries, additional reporting requirements and oversight if we become subject to a corporate integrity agreement or similar agreement to resolve allegations of non-compliance with these laws, contractual damages, diminished profits and future earnings, reputational harm and the curtailment or restructuring of our operations, any of which could harm our business.

The risk of our being found in violation of these laws is increased by the fact that many of them have not been fully interpreted by the regulatory authorities or the courts, and their provisions are open to a variety of interpretations. Efforts to ensure that our business arrangements with third parties will comply with applicable healthcare laws and regulations will involve substantial costs. Any action against us for violation of these laws, 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. The shifting compliance environment and the need to build and maintain robust and expandable systems to comply with multiple jurisdictions with different compliance and/or reporting requirements increases the possibility that a healthcare company may run afoul of one or more of the requirements.

Even if we obtain regulatory approval for INVA8001, INVA8003 or any future product candidates, they will remain subject to ongoing regulatory oversight.

Even if we obtain any regulatory approval for INVA8001, INVA8003 or any future product candidates, such product candidates, once approved, will be subject to ongoing regulatory requirements applicable to manufacturing, labeling, packaging, storage, advertising, promoting, sampling, record-keeping and submitting of safety and other post-market information, among other things. These requirements include submissions of safety and other post-marketing information and reports, registration, as well as continued compliance with cGMPs and cGCPs requirements for any clinical trials that we conduct post-approval.

Manufacturers of approved products and their facilities are subject to continual review and periodic, unannounced inspections by the U.S. FDA and other regulatory authorities for compliance with cGMP regulations and standards. Any regulatory approvals that we receive for INVA8001, INVA8003 or any future product candidates

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may also be subject to a risk evaluation and mitigation strategy, limitations on the approved indicated uses for which the drug may be marketed or to the conditions of approval, or requirements that we conduct potentially costly post-marketing testing, including Phase 4 trials and surveillance to monitor the quality, safety and efficacy of the drug. An unsuccessful post-marketing study or failure to complete such a study could result in the withdrawal of marketing approval. We will further be required to immediately report any serious and unexpected adverse events and certain quality or production problems with our products to regulatory authorities along with other periodic reports.

Any new legislation addressing drug safety issues could result in delays in product development or commercialization, or increased costs to ensure compliance. We will also have to comply with requirements concerning advertising and promotion for our products. Promotional communications with respect to prescription drug products are subject to a variety of legal and regulatory restrictions and must be consistent with the information in the product’s approved label. As such, we will not be allowed to promote our products for indications or uses for which they do not have approval, commonly known as off-label promotion. Physicians, on the other hand, may prescribe products for off-label uses. Although the U.S. FDA and other regulatory agencies do not regulate a physician’s choice of drug treatment made in the physician’s independent medical judgment, they do restrict promotional communications from companies or their sales force with respect to off-label uses of products for which marketing approval has not been issued. However, companies may share truthful and not misleading information that is otherwise consistent with a product’s U.S. FDA, European Commission/EMA or other regulatory agency approved labeling. The holder of an approved NDA must submit new or supplemental applications and obtain prior approval for certain changes to the approved product, product labeling, or manufacturing process. A company that is found to have improperly promoted off-label uses of their products may be subject to significant civil, criminal and administrative penalties.

In addition, drug manufacturers are subject to payment of user fees and continual review and periodic inspections by the U.S. FDA and other regulatory authorities for compliance with cGMP requirements and adherence to commitments made in the NDA or foreign marketing authorization application. If we, or a regulatory authority, discover previously unknown problems with a drug, such as adverse events of unanticipated severity or frequency, or problems with the facility where the drug is manufactured or if a regulatory authority disagrees with the promotion, marketing or labeling of that drug, a regulatory authority may impose restrictions relative to that drug, the manufacturing facility or us, including requesting a recall or requiring withdrawal of the drug from the market or suspension of manufacturing.

If we fail to comply with applicable regulatory requirements following approval of any of our product candidates, a regulatory authority may:

• issue an untitled letter or warning letter asserting that we are in violation of the law;

• seek an injunction or impose administrative, civil or criminal penalties or monetary fines, disgorgement or profits or revenue, warning letters or adverse publicity requirements;

• suspend or withdraw regulatory approval;

• restrict product distribution or use, including full or partial holds on any ongoing or planned clinical trials;

• refuse to approve a pending NDA or comparable foreign marketing application (or any supplements thereto) submitted by us or our strategic partners;

• restrict the marketing or manufacturing of the drug;

• seize or detain the drug or otherwise require the withdrawal of the drug from the market;

• refuse to permit the import or export of product candidates; or

• refuse to allow us to enter into supply contracts, including government contracts.

Any government investigation of alleged violations of law could require us to expend significant time and resources in response and could generate negative publicity. The occurrence of any event or penalty described above may inhibit our ability to commercialize our product candidates and harm our business, financial condition, results of operations and prospects. In addition, regulatory authorities may impose the obligation to conduct post marketing safety or efficacy studies.

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Healthcare legislative or regulatory reform measures may have a negative impact on our business and results of operations.

In the United States and many foreign jurisdictions, there have been, and continue to be, several legislative and regulatory changes and proposed changes regarding the healthcare system that could prevent or delay marketing approval of product candidates, restrict or regulate post-approval activities, and affect our ability to profitably sell any product candidates for which we obtain marketing approval.

Among policy makers and payors in the United States and elsewhere, there is significant interest in promoting changes in healthcare systems with the stated goals of containing healthcare costs, improving quality and/or expanding access. In the United States, the pharmaceutical industry has been a particular focus of these efforts and has been significantly affected by major legislative initiatives, including the Patient Protection and Affordable Care Act, or ACA and the Inflation Reduction Act, or IRA, which introduce pricing and reimbursement constraints that may impact our business. In March 2010, the Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act, or collectively, the ACA, was passed, which substantially changed the way healthcare is financed by both the government and private insurers, and significantly impacts the U.S. pharmaceutical industry. The ACA, among other things: (1) established an annual, nondeductible fee on any entity that manufactures or imports certain specified branded prescription drugs and biologic agents apportioned among these entities according to their market share in some government healthcare programs; (2) expanded the entities eligible for discounts under the 340B drug pricing program; (3) increased the statutory minimum rebates a manufacturer must pay under the Medicaid Drug Rebate Program to 23.1% and 13% of the average manufacturer price for most branded and generic drugs, respectively, and capped the total rebate amount for innovator drugs at 100% of the Average Manufacturer Price, or AMP; (4) expanded the eligibility criteria for Medicaid programs by, among other things, allowing states to offer Medicaid coverage to additional individuals and by adding new mandatory eligibility categories for individuals with income at or below 133% of the federal poverty level, thereby potentially increasing manufacturers’ Medicaid rebate liability; (5) addressed a new methodology by which rebates owed by manufacturers under the Medicaid Drug Rebate Program are calculated for certain drugs and biologics that are inhaled, infused, instilled, implanted or injected; (6) introduced a new Medicare Part D coverage gap discount program in which manufacturers must now agree to offer 70% point-of-sale discounts off negotiated prices of applicable brand drugs to eligible beneficiaries during their coverage gap period as a condition for the manufacturer’s outpatient drugs to be covered under Medicare Part D; (7) created a new Patient-Centered Outcomes Research Institute to oversee, identify priorities in, and conduct comparative clinical effectiveness research, along with funding for such research; and (8) established a Center for Medicare and Medicaid Innovation at CMS to test innovative payment and service delivery models to lower Medicare and Medicaid spending, potentially including prescription drug spending.

There have been judicial, executive and Congressional challenges to certain aspects of the ACA. While Congress has not passed comprehensive repeal legislation, several bills affecting the implementation of certain taxes under the ACA have been signed into law. Further, on August 16, 2022, the Inflation Reduction Act of 2022, or IRA, was enacted which, among other things, extends enhanced subsidies for individuals purchasing health insurance coverage in ACA marketplaces through plan year 2025. The IRA also eliminates the “donut hole” under the Medicare Part D program beginning in 2025 by significantly lowering the beneficiary maximum out-of-pocket cost and created a new manufacturer discount program and a new drug price negotiation program discussed in more detail below. President Trump has begun taking a number of actions, such as executive orders and other announcements, that may impact the health care delivery system and federal health care program reimbursement. For example, the One Big Beautiful Bill Act, or the OBBBA, which was enacted in July 2025, imposes significant reductions in the funding of the Medicaid program. Such reductions are expected to decrease the number of persons enrolled in Medicaid and reduce the services covered by Medicaid, which could adversely affect potential sales of our product candidates and limit the number of patients that could receive procedures that could be associated with the use of our product candidates in the future. It is unclear how the healthcare reform measures of the Trump administration will impact these programs and our business but a decrease in the number of insured potential customers or reimbursement levels for our product candidates in the U.S. could affect our ability to generate revenue in the future. It is also possible that efforts to reform, modify or repeal parts of the ACA may continue.

Other legislative changes have been proposed and adopted since the ACA was enacted. These changes include aggregate reductions to Medicare payments to providers of 2% per fiscal year pursuant to the Budget Control Act of 2011, which began in 2013 and the Consolidated Appropriations Act of 2023, and due to subsequent legislative amendments to the statute, including the Infrastructure Investment and Jobs Act, will remain in effect until 2032, unless additional Congressional action is taken. In addition, the American Taxpayer Relief Act of 2012, among other

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things, further reduced Medicare payments to several providers and increased the statute of limitations period for the government to recover overpayments to providers from three to five years. These laws may result in additional reductions in Medicare and other healthcare funding, which could have an adverse effect on customers for our product candidates, if approved, and, accordingly, our financial operations. Further, on March 11, 2021, the American Rescue Plan Act of 2021 was enacted into law, which eliminates the statutory Medicaid drug rebate cap, currently set at 100% of a drug’s average manufacturer price, for single source and innovator multiple source drugs, beginning January 1, 2024.

In the EU, similar healthcare reforms continue to evolve, aimed at balancing cost containment, patient access, and innovation. Many EU member states impose strict price controls, HTAs, and external reference pricing, or ERP mechanisms that compare drug prices across multiple countries to set reimbursement levels. These cost-control measures may affect the pricing and reimbursement of our products in Europe. Additionally, the European Commission’s Pharmaceutical Strategy for Europe, ongoing revisions to the EU pharmaceutical legislation, and country-specific initiatives such as national tendering and budget caps for medicines could further impact market access, impose additional post-marketing requirements, and delay reimbursement decisions. Some member states have also explored joint procurement initiatives, which may further limit pricing control and affect market entry. Furthermore, the EU’s increasing emphasis on transparency in pharmaceutical pricing and reimbursement may lead to additional cost-containment measures that could negatively impact our ability to commercialize our products profitably in the region. At the member state level, legislatures have increasingly passed legislation and implemented regulations designed to control pharmaceutical and biological product pricing, including price or reimbursement constraints, discounts, restrictions on certain product access and marketing cost disclosure and transparency measures, and, in some cases, designed to encourage importation from other countries and bulk purchasing.

Additionally, there has been heightened governmental scrutiny in the United States of pharmaceutical pricing practices considering the rising cost of prescription drugs and biologics. Such scrutiny has resulted in several recent congressional inquiries and proposed and enacted federal and state legislation designed to, among other things, bring more transparency to product pricing, review the relationship between pricing and manufacturer patient programs, and reform government program reimbursement methodologies for products. At the federal level, in July 2021, the Biden administration released an executive order, “Promoting Competition in the American Economy,” with multiple provisions aimed at prescription drugs. In response to Biden’s executive order, on September 9, 2021, the U.S. Department of Health and Human Services, or HHS, released a Comprehensive Plan for Addressing High Drug Prices that outlines principles for drug pricing reform and sets out a variety of potential legislative policies that Congress could pursue as well as potential administrative actions HHS can take to advance these principles. In addition, the IRA, among other things, (1) directs HHS to negotiate the price of high-expenditure, certain single-source drugs and biologics covered under Medicare and (2) imposes rebates under Medicare Part B and Medicare Part D to penalize price increases that outpace inflation. These provisions will take effect progressively starting in fiscal year 2023, although the Medicare drug pricing negotiation program is currently subject to legal challenges. The IRA permits HHS to implement many of these provisions through guidance, as opposed to regulation, for the initial years. HHS has and will continue to issue and update guidance as these programs are implemented. It is currently unclear how the IRA will be effectuated but it is likely the IRA will have a significant impact on the pharmaceutical industry. In addition, in response to the Biden administration’s October 2022 executive order, on February 14, 2023, HHS released a report outlining three new models for testing by the Center for Medicare and Medicaid Innovation which will be evaluated on their ability to lower the cost of drugs, promote accessibility, and improve quality of care. It is unclear whether the models will be utilized in any health reform measures in the future. The Trump administration has rescinded a number of President Biden’s executive orders and issued numerous executive orders of its own that may impact drug prices. Changes in HHS leadership may result in significant and unexpected changes in direction of drug pricing policy.

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 our product candidates, if approved, or put pressure on our product pricing, which could negatively affect our business, results of operations, financial condition and prospects.

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We expect that these and other healthcare U.S. and EU healthcare reform measures that may be adopted in the future may result in more rigorous coverage criteria and in additional downward pressure on the price that we receive for any approved drug. Any reduction in reimbursement from Medicare, EU national healthcare systems or other government programs may result in a similar reduction in payments from private payors. The implementation of cost containment measures or other healthcare reforms may prevent us from being able to generate revenue, attain profitability, or commercialize our drugs.

Furthermore, revisions to the EU regulatory framework and national healthcare policies in EU member states may introduce additional compliance obligations or stricter conditions for obtaining reimbursement, which could delay product launches or limit market access.

In addition, U.S. FDA regulations and guidance may be revised or reinterpreted by the U.S. FDA in ways that may significantly affect our business and our products. If executive actions impose restrictions on the U.S. FDA’s ability to engage in oversight and implementation activities in the normal course, our business may be negatively impacted. Any new regulations or guidance, or revisions or reinterpretations of existing regulations or guidance, may impose additional costs or lengthen U.S. FDA review times for our product candidates. We cannot determine how changes in regulations, statutes, policies, or interpretations when and if issued, enacted or adopted, may affect our business in the future. Such changes could, among other things, require:

• additional clinical trials to be conducted prior to obtaining approval;

• changes to manufacturing methods;

• recalls, replacements, or discontinuance of one or more of our products; and

• additional recordkeeping.

Such changes would likely require substantial time and impose significant costs, or could reduce the potential commercial value of our product candidates, and could materially harm our business and our financial results. In addition, delays in receipt of or failure to receive regulatory clearances or approvals for any other products would harm our business, financial condition, and results of operations. Further, we cannot predict the likelihood, nature, or extent of healthcare reform initiatives that may arise from future legislation or administrative action.

We and any of our potential future collaborators will be required to report to regulatory authorities if any of our approved products cause or contribute to adverse medical events, and any failure to do so would result in sanctions that would materially harm our business.

If we or any of our potential future collaborators are successful in commercializing our products, the U.S. FDA and other foreign regulatory authorities would require that we and such collaborators report certain information about adverse medical events if those products may have caused or contributed to those adverse events. The timing of our obligation to report would be triggered by the date we become aware of the adverse event as well as the nature of the event. We and any of our potential future collaborators or CROs may fail to report adverse events within the prescribed timeframe. If we or any of our potential future collaborators or CROs fail to comply with such reporting obligations, the U.S. FDA or a foreign regulatory authority could take action, including criminal prosecution, the imposition of civil monetary penalties, seizure of our products or delay in approval or clearance of future products.

Risks Related to Our Business Operations, Employee Matters, and Managing our Growth

Our future success depends on our ability to retain key executives and to attract, retain and motivate qualified personnel.

Our success depends in part on our continued ability to attract, retain and motivate highly qualified management, clinical and scientific personnel. Each of our executive officers may currently terminate their employment with us at any time. We do not maintain “key person” insurance for any of our executives or employees. This lack of insurance means that we may not have adequate compensation for the loss of the services of these individuals. In addition, following the expiration of the InveniAI Shared Services Agreement with InveniAI, there is a possibility that we may not be able to perform all of the functions provided by InveniAI in-house or secure replacement services with the same effectiveness, on the same terms or at all.

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Due to funding limitations and the need to reduce expenses, each of our Chief Medical Officer and our Chief Scientific Officer previously took a leave of absence and since May 2025 has been working limited hours at reduced pay. If we are unable to raise capital to provide competitive compensation to our executive officers and key personnel, we may have difficulty retaining such executive officers and key personnel and our ability to attract highly qualified management, clinical and scientific personnel could be significantly impeded.

The loss of the services of our executive officers or other key employees could impede the achievement of our development and commercialization objectives and seriously harm our ability to successfully implement our business strategy. Furthermore, replacing executive officers and key employees may be difficult and may take an extended period of time because of the limited number of individuals in our industry with the breadth of skills and experience required to successfully develop, gain regulatory approval of and commercialize products. Competition to hire from this limited pool is intense, and we may be unable to hire, train, retain or motivate these key personnel on acceptable terms given the competition among numerous pharmaceutical and biotechnology companies for similar personnel. In addition, pursuant to our non-compete agreement, we agreed not to solicit employees for a period of two years from the effective date of the agreement. We also experience competition for the hiring of scientific and clinical personnel from universities and research institutions. In addition, we rely on consultants and advisors, including scientific and clinical advisors, to assist us in formulating our development and commercialization strategy. Our consultants and advisors may be employed by employers other than us and may have commitments under consulting or advisory contracts with other entities that may limit their availability to us. If we are unable to continue to attract and retain high quality personnel, our ability to pursue our growth strategy will be limited.

Further, job candidates and existing employees often consider the value of the stock awards they receive in connection with their employment. If the perceived benefits of our stock awards decline, either because we are a public company or for other reasons, it may harm our ability to recruit and retain highly skilled employees. Our employees may be more likely to leave us if the shares they own have significantly appreciated in value relative to the original purchase prices of the shares, or if the exercise prices of the options that they hold are significantly below the market price of our common stock, particularly after the expiration of the lock-up agreements described herein.

We have certain unresolved potential liabilities, which could result in legal liability and materially impair our business operations.

As of the date of this offering, we have certain unresolved potential liabilities, including claims for unpaid wages by our executive officers in the total amount of approximately $ million as of September 30, 2025, together with potential claims for violations of federal and state law. With the consent of these executive officers, we are deferring payment of these amounts and are accruing the resulting indebtedness on our financial statements. These executive officers are not obligated to continue to consent to these deferrals and have the right at any time to insist on full payment of the deferred amounts. Upon the closing of this offering, we expect to pay such unpaid wages and to obtain related releases. However, there can be no guarantee that we will be able to pay such unpaid wages or obtain such releases. If we are unable to resolve these potential claims, we could be subject to legal liability.

We expect to expand our clinical development and regulatory capabilities and potentially implement sales, marketing and distribution capabilities, and as a result, we may encounter difficulties in managing our growth, which could disrupt our operations.

As of , 2025, we had four full time employees and three part-time employees and have engaged various outside consultants, principally in the areas of research and development, corporate development and regulatory affairs. As we continue to build our organization and execute on our strategy, we expect to experience significant growth in the number of our employees and the scope of our operations, particularly in the areas of clinical product development, regulatory affairs and, if any of our product candidates receives marketing approval, sales, marketing and distribution. To manage our anticipated future growth, we must continue to implement and improve our managerial, operational and financial systems, expand our facilities and continue to recruit and train additional qualified personnel. Due to our limited financial resources and the limited experience of our management team in managing a company with such anticipated growth, we may not be able to effectively manage the expansion of our operations or recruit and train additional qualified personnel. The expansion of our operations may lead to significant costs and may divert our management, business, and development resources. Any inability to manage growth could delay the execution of our business plans or disrupt our operations. Our future financial performance and our ability to compete effectively will depend, in part, on our ability to manage our growth effectively.

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Our business could be affected by litigation, government investigations and enforcement actions.

We currently operate and plan to operate in a highly regulated industry and we could now or in the future be subject to litigation, government investigation and enforcement actions on a variety of matters in the United States or foreign jurisdictions, including, without limitation, intellectual property, regulatory, product liability, environmental, whistleblower, false claims, privacy, anti-kickback, anti-bribery, securities, commercial, employment and other claims and legal proceedings which may arise from conducting our business. Any determination that our operations or activities are not in compliance with existing laws or regulations could result in the imposition of fines, civil and criminal penalties, equitable remedies, including disgorgement, injunctive relief and/or other sanctions against us, and remediation of any such findings could have an adverse effect on our business operations.

Legal proceedings, government investigations and enforcement actions can be expensive and time-consuming. An adverse outcome resulting from any such proceedings, investigations or enforcement actions could result in significant damages awards, fines, penalties, exclusion from the federal healthcare programs, healthcare debarment, injunctive relief, product recalls, reputational damage and modifications of our business practices, which could have a material adverse effect on our business and results of operations. Even if such a proceeding, investigation or enforcement action is ultimately decided in our favor, the investigation and defense thereof could require substantial financial and management resources.

Our employees, independent contractors, consultants, commercial collaborators, principal investigators, CROs, suppliers and vendors may engage in misconduct or other improper activities, including non-compliance with regulatory standards and requirements.

We are exposed to the risk that our employees, independent contractors, consultants, commercial collaborators, principal investigators, CROs, suppliers and vendors may engage in fraudulent conduct or other illegal activity. Misconduct by these parties could include intentional, reckless and/or negligent conduct or disclosure of unauthorized activities to us that violates U.S. or foreign law or U.S. FDA or other comparable regulatory authority regulations, including those laws requiring the reporting of true, complete and accurate information to the U.S. FDA, EMA or other comparable regulatory authority, manufacturing standards, foreign, federal and state healthcare laws and regulations, and laws that require the true, complete and accurate reporting of financial information or data. In particular, sales, marketing and business arrangements in the healthcare industry are subject to extensive laws and regulations intended to prevent fraud, 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. Misconduct by these parties could also involve the improper use or misrepresentation of individually identifiable information, including, without limitation, information obtained in the course of clinical trials, which could result in regulatory sanctions and serious harm to our reputation. We intend to adopt a code of business conduct and ethics, but it is not always possible to identify and deter misconduct, 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 be in compliance with such laws or regulations. In addition, 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, including the imposition of significant civil, criminal and administrative penalties, including, without limitation, damages, fines, disgorgement, imprisonment, exclusion from participation in government healthcare programs, such as Medicare and Medicaid, imprisonment, contractual damages, reputational harm, diminished profits and future earnings, additional reporting requirements and oversight if we become subject to a corporate integrity agreement or similar agreement to resolve allegations of non-compliance with these laws, and the curtailment or restructuring of our operations. Any of these could adversely affect our ability to operate our business and our results of operations.

If our third-party manufacturers or suppliers do not comply with laws regulating the protection of the environment and health and human safety, our business could be affected adversely.

We and any contract manufacturers and suppliers we engage are subject to numerous federal, state and local environmental, health, and safety laws, regulations and permitting requirements, including those governing laboratory procedures; the generation, handling, use, storage, treatment and disposal of hazardous and regulated materials and wastes; the emission and discharge of hazardous materials into the ground, air and water; and employee health and

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safety. Although our current operations do not involve the use of hazardous and flammable materials, including chemicals and biological materials, our third-party manufacturers or suppliers use, and potential future collaborators will use, biological materials, potent chemical agents and may use hazardous materials, including chemicals and biological agents and compounds that could be dangerous to human health and safety of the environment. Our third-party suppliers may also produce hazardous waste products. We do not carry specific biological or hazardous waste insurance coverage, and our property, casualty and general liability insurance policies specifically exclude coverage for damages and fines arising from biological or hazardous waste exposure or contamination. In the event of contamination or injury at our manufacturers’ or suppliers’ sites, we could be held liable for damages or be penalized with fines in an amount exceeding our resources, and our clinical trials or regulatory approvals could be suspended. Our third-party manufacturers and suppliers cannot eliminate the risk of accidental injury or contamination from these materials or wastes. We or our third-party manufacturers and suppliers may incur substantial costs to comply with, and substantial fines or penalties if our manufacturers or suppliers violate, any of these laws or regulations.

In addition, our third-party manufacturers and suppliers may need to incur substantial costs in order to comply with current or future environmental, health and safety laws and regulations, which have tended to become more stringent over time, which may increase the cost of their services to us. These current or future laws and regulations may impair our research, development or production efforts. Failure to comply with these laws and regulations also may result in substantial fines, penalties or other sanctions or liabilities for our third-party manufacturers and suppliers, which could in turn materially adversely affect our business, financial condition, results of operations and prospects. To the extent we develop our own manufacturing operations in the future, we may similarly incur substantial costs to ensure compliance with these laws, and all the foregoing risks will further apply to us, as well.

Our insurance policies are expensive and only protect us from some business risks, which will leave us exposed to significant uninsured liabilities.

We do not carry insurance for all categories of risk that our business may encounter. Some of the policies we currently maintain include property, general liability, employment benefits liability, workers’ compensation, cyber, directors’ and officers’ and employment practices insurance. We do not know, however, if we will be able to maintain insurance with adequate levels of coverage. No assurance can be given that an insurance carrier will not seek to cancel or deny coverage after a claim has occurred. Any significant uninsured liability may require us to pay substantial amounts, which would adversely affect our financial position and results of operations.

We may engage in strategic transactions that could increase our capital requirements, dilute our stockholders, cause us to incur debt or assume contingent liabilities, subject us to other risks, adversely affect our liquidity, increase our expenses and present significant distractions to our management.

Although we currently have no agreements or commitments to complete any such transactions and are not involved in negotiations to do so, from time to time, we may consider strategic transactions, such as acquisitions of companies, asset purchases and out-licensing or in-licensing of intellectual property, products or technologies. Additional potential transactions that we may consider in the future include a variety of business arrangements, including spin-offs, strategic partnerships, joint ventures, restructurings, divestitures, business combinations and investments. We may not be able to find suitable partners or acquisition candidates, and we may not be able to complete such transactions on favorable terms, if at all. Any future transactions could increase our near and long-term expenditures, result in potentially dilutive issuances of our equity securities, including our common stock, or the incurrence of debt, contingent liabilities, amortization expenses or acquired in-process research and development expenses, any of which could affect our financial condition, liquidity and results of operations. Future acquisitions may also require us to obtain additional financing, which may not be available on favorable terms or at all. These transactions may never be successful and may require significant time and attention of our management. In addition, the integration of any business that we may acquire in the future may disrupt our existing business and may be a complex, risky and costly endeavor for which we may never realize the full benefits. Furthermore, we may experience losses related to investments in other companies, including as a result of failure to realize expected benefits or the materialization of unexpected liabilities or risks, which could have a material negative effect on our results of operations and financial condition. Accordingly, although there can be no assurance that we will undertake or successfully complete any additional transactions of the nature described above, any additional transactions that we do complete could have a material adverse effect on our business, results of operations, financial condition and prospects.

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Business disruptions could seriously harm our future revenue and financial condition and increase our costs and expenses.

Our operations and the operations of our suppliers, CROs, CMOs and clinical sites could be subject to earthquakes, power shortages, telecommunications or infrastructure failures, cybersecurity incidents, physical security breaches, water shortages, floods, hurricanes, typhoons, blizzards and other extreme weather conditions, fires, public health pandemics or epidemics and other natural or manmade disasters or business interruptions, for which we are predominantly self-insured. We rely or expect to rely on third-party manufacturers or suppliers to produce our product candidates and its components and on CROs and clinical sites to conduct our clinical trials, and do not have a redundant source of supply for all components of our product candidate. Our ability to obtain clinical or, if approved, commercial, supplies of our product candidates or any future product candidates could be disrupted if the operations of these suppliers were affected by a man-made or natural disaster or other business interruption, and our ability to commence, conduct or complete our clinical trials in a timely manner could be similarly adversely affected by any of the foregoing. The occurrence of any of these business disruptions could seriously harm our operations and financial condition and increase our costs and expenses.

Risks Related to this Offering, Ownership of our Common Stock and our Status as a Public Company

There has been no prior public market for our common stock. An active trading market for our common stock may not develop and you may not be able to resell your shares of our common stock at or above the initial offering price, if at all.

Prior to this offering, there has been no public market for our common stock. The initial public offering price for our common stock was determined through negotiations with the underwriters and may not be indicative of the price at which our common stock will trade after the closing of this offering. Although we have applied to list our common stock on the Nasdaq Capital Market, an active trading market for our shares may never develop or be sustained following this offering. If an active market for our common stock does not develop or is not sustained, it may be difficult for you to sell shares you purchased in this offering at an attractive price or at all. An inactive market may also impair our ability to raise capital by selling shares and may impair our ability to acquire other businesses or technologies using our shares as consideration, which, in turn, could materially adversely affect our business.

If, after listing, we fail to satisfy the continued listing requirements of Nasdaq, such as the corporate governance requirements or the minimum closing bid price requirement, Nasdaq may take steps to delist our common stock. Such a delisting would likely have a negative effect on the price of our common stock and would impair your ability to sell or purchase our common stock when you wish to do so. In the event of a delisting, we can provide no assurance that any action taken by us to restore compliance with listing requirements would allow our common stock to become listed again, stabilize the market price or improve the liquidity of our common stock, prevent our common stock from dropping below the Nasdaq minimum bid price requirement or prevent future non-compliance with the listing requirements of Nasdaq.

The trading price of the shares of our common stock may be volatile, and purchasers of our common stock could incur substantial losses.

Our stock price may be volatile and subject to wide fluctuations in response to various factors, some of which we cannot control. The stock market in general and the market for biopharmaceutical companies in particular have experienced extreme volatility that has often been unrelated to the operating performance of particular companies. As a result of this volatility, investors may not be able to sell their common stock at or above the price paid for the shares. The market price for our common stock may be influenced by many factors, including:

• the commencement, enrollment or results of our clinical trials of INVA8001, INVA8003 or any future clinical trials we may conduct, or changes in the development status of our product candidates;

• any delay in our regulatory filings for INVA8001, INVA8003 or any other product candidate we may develop, and any adverse development or perceived adverse development with respect to the applicable regulatory authority’s review of such filings, including without limitation the any regulatory agencies issuance of a “refusal to file” letter or a request for additional information;

• the reporting of unfavorable preclinical results;

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• the success or failure to identify, develop, acquire or license additional product candidates;

• the degree and rate of physician and market adoption of any of our current and future product candidates;

• manufacturing, supply or distribution delays or shortages, including our inability to obtain adequate product supply, at acceptable prices, or at all;

• the success of competitive products or announcements by potential competitors of their product development efforts;

• adverse results from, delays in or termination of clinical trials;

• adverse regulatory decisions, including failure to receive regulatory approval of our product candidates;

• developments or disputes concerning patent applications, issued patents or other proprietary rights;

• unanticipated serious safety concerns related to the use of INVA8001, INVA8003 or any other product candidate;

• changes in financial estimates by us or by any equity research analysts who might cover our stock;

• achievement or failure to achieve expected sales or profitability;

• changes in our capital structure, such as future issuances of securities and the incurrence of additional debt;

• conditions or trends in our industry;

• changes in the market valuations of similar companies;

• stock market price, volume fluctuations, or news related to affiliates of the parent company of our parent, InveniAI;

• stock market price and volume fluctuations of comparable companies and, in particular, those that operate in the biopharmaceutical industry;

• publication of research reports about us or our industry or positive or negative recommendations or withdrawal of research coverage by securities analysts;

• announcements by us or our competitors of significant acquisitions, strategic collaborations, joint ventures, capital commitments or divestitures;

• announcements of investigations or regulatory scrutiny of our operations or lawsuits filed against us;

• investors’ general perception of our company and our business;

• third party publications and discussions about our business on social media, forums and other websites;

• recruitment or departure of key personnel;

• overall performance of the equity markets;

• trading volume of our common stock;

• ability to obtain additional funding or obtaining funding on unattractive terms;

• sales of common stock by us, our insiders or our other stockholders;

• the concentrated ownership of our common stock;

• expiration of market stand-off or lock-up agreements;

• disputes or other developments relating to proprietary rights, including patents, litigation matters and our ability to obtain patent protection for our technologies;

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• significant lawsuits, including patent or stockholder litigation;

• changes in the structure of healthcare payment systems;

• changes in accounting standards, policies, guidelines, interpretations or principles;

• regulatory or legal developments in the United States and foreign countries;

• general political and economic conditions, many of which are beyond our control; and

• other events or factors, many of which are beyond our control.

The stock market in general, and the Nasdaq Capital Market and biotechnology companies in particular, have experienced extreme price and volume fluctuations that have often been unrelated or disproportionate to the operating performance of these companies, including in connection with global pandemics, geopolitical disputes and general economic uncertainty, which has resulted in decreased stock prices for many companies notwithstanding the lack of a fundamental change in their underlying business models or prospects. Broad market and industry factors, including potentially worsening economic conditions, may negatively affect the market price of our common stock, regardless of our actual operating performance. The realization of any of the above risks or any of a broad range of other risks, including those described in this section, could have a significant and material adverse impact on the market price of our common stock.

In addition, in the past, stockholders have initiated class action lawsuits against pharmaceutical and biotechnology companies following periods of volatility in the market prices of these companies’ stock.

Such litigation, if instituted against us, could cause us to incur substantial costs and divert management’s attention and resources from our business.

If you purchase shares of our common stock in this offering, you will suffer immediate and substantial dilution of your investment.

The initial public offering price of our common stock is substantially higher than the net tangible book value per share of our common stock immediately after the completion of this offering. Therefore, if you purchase shares of our common stock in this offering, you will pay a price per share that substantially exceeds our pro forma as adjusted net tangible book value per share after this offering. Based on the initial public offering price of $ per share, which is the mid-point of the price range set forth on the cover of this prospectus, you will experience immediate dilution of $ per share, representing the difference between our pro forma as adjusted net tangible book value per share as of September 30, 2025, and the initial public offering price. For a further description of the dilution that you will face immediately after this offering, see “Dilution.”

If equity research analysts do not publish research or reports, or publish unfavorable research or reports, about us, our business or our market, our stock price and trading volume could decline.

The trading market for our common stock will be influenced by the research and reports that equity research analysts publish about us, our business and our market. We do not currently have and may never obtain research coverage by securities or industry analysts, and such lack of research coverage may adversely affect the market price of our common stock. In the event we do have equity research analyst coverage, we will not have any control over the analysts or the content and opinions included in their reports. The price of our stock could decline if one or more equity research analysts downgrade our stock or issue other unfavorable commentary or research. If one or more equity research analysts ceases coverage of our company or fails to publish reports on us regularly, demand for our stock could decrease, which in turn could cause our stock price or trading volume to decline.

A significant portion of our total outstanding shares are restricted from immediate resale but may be sold into the market in the near future. This could cause the market price of our common stock to drop significantly, even if our business is doing well.

Sales of a substantial number of shares of our common stock in the public market could occur at any time. If our stockholders sell, or the market perceives that our stockholders intend to sell, substantial amounts of our common stock in the public market, the market price of our common stock could decline significantly and impair our ability to raise adequate capital through the sale of additional equity or equity-linked securities.

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Upon the closing of this offering, we will have outstanding shares of common stock, after giving effect to the automatic conversion of our redeemable convertible preferred stock outstanding as of September 30, 2025, into 8,342,707 shares of our common stock , and shares after conversion of our convertible debt instruments, and assuming no exercise of outstanding options and warrants. Of these, the shares sold in this offering will be freely tradable immediately after this offering and substantially all of the additional shares of common stock will be available for sale in the public market following the expiration of lock-up agreements between us, our directors, officers, substantially all of our stockholders and the underwriters. The foregoing agreements are subject to certain limited exceptions, and the underwriters may release these stockholders from their lock-up agreements at any time and without notice, which would allow for earlier sales of shares in the public market. See “Underwriting.”

In addition, promptly following the closing of this offering, we intend to file one or more registration statements on Form S-8 under the Securities Act of 1933, as amended, or the Securities Act, registering the issuance of shares of common stock subject to options or other equity awards issued or reserved for future issuance under our equity incentive plans. Shares registered under these registration statements on Form S-8 will be available for sale in the public market subject to vesting arrangements and exercise of options, the lock-up agreements described above and the restrictions of Rule 144 in the case of our affiliates.

Additionally, after this offering, the holders of an aggregate of 8,342,707 shares of our common stock, or their transferees, will have rights, subject to some conditions, to require us to file one or more registration statements covering their shares or to include their shares in registration statements that we may file for ourselves or other stockholders. If we were to register the resale of these shares, they could be freely sold in the public market. If these additional shares are sold, or if it is perceived that they will be sold, in the public market, the trading price of our common stock could decline.

Provisions in our corporate charter documents and under Delaware law may prevent or frustrate attempts by our stockholders to change our management and hinder efforts to acquire a controlling interest in us, and the market price of our common stock may be lower as a result.

Provisions in our amended and restated certificate of incorporation and amended and restated bylaws that will be in effect immediately prior to the consummation of this offering may significantly reduce the value of our shares to a potential acquiror or make it difficult for a third party to acquire, or attempt to acquire, control of our company, even if a change of control was considered favorable by you and other stockholders. For example, our board of directors will have the authority to issue up to 10,000,000 shares of “blank check” preferred stock. The board of directors can fix the price, rights, preferences, privileges, and restrictions of the preferred stock without any further vote or action by our stockholders. The issuance of shares of preferred stock may delay or prevent a change of control transaction. As a result, the market price of our common stock and the voting and other rights of our stockholders may be adversely affected. An issuance of shares of preferred stock may result in the loss of voting control to other stockholders.

Our charter documents will also contain other provisions that could have an anti-takeover effect, including:

• only one of our three classes of directors will be elected each year;

• stockholders will not be entitled to remove directors other than by a 66 2⁄3% vote and only for cause;

• stockholders will not be permitted to take actions by written consent;

• stockholders cannot call a special meeting of stockholders; and

• stockholders must give advance notice to nominate directors or submit proposals for consideration at stockholder meetings.

In addition, we are subject to the anti-takeover provisions of Section 203 of the Delaware General Corporation Law, which regulates corporate acquisitions by prohibiting Delaware corporations from engaging in specified business combinations with particular stockholders of those companies. These provisions could discourage potential acquisition proposals and could delay or prevent a change of control transaction. They could also have the effect of discouraging others from making tender offers for our common stock, including transactions that may be in your best interests. These provisions may also prevent changes in our management or limit the price that investors are willing to pay for our stock.

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Concentration of ownership of our common stock among our current parent company and existing executive officers, directors and principal stockholders may prevent new investors from influencing significant corporate decisions.

Following the completion of this offering, our executive officers, directors and current beneficial owners of 5% or more of our common stock and their respective affiliates will beneficially own approximately % of our outstanding common stock (assuming no exercise of the underwriters’ option to purchase additional shares and no exercise of outstanding options and warrants and without giving effect to (i) any potential purchases by such persons in this offering, (ii) conversion of $1.2 million of the CEO SAFEs into shares of our common stock upon closing of this offering (assuming a price per share of $ which is the mid-point of the price range indicated on the cover of this prospectus) or (iii) issuance of options to be granted to certain of our employees and non-employee directors upon pricing of this offering). In addition, assuming (i) an initial public offering price of $ per share, the midpoint of the price range set forth on the cover page of this prospectus, and (ii) that the number of shares offered by us, as set forth on the cover page of this prospectus, remains the same, subsequent to the offering InveniAI will own approximately % of the economic interest and voting power of our outstanding common stock and approximately % of such interest and power if the underwriters’ option to purchase additional shares is exercised in full. As a result, these persons, acting together, would be able to control all matters requiring stockholder approval, including the election and removal of directors, any merger, consolidation, sale of all or substantially all of our assets, or other significant corporate transactions.

Some of these persons or entities may have interests different than yours. For example, because many of these stockholders purchased their shares at prices substantially below the current market price of our common stock and have held their shares for a longer period, they may be more interested in selling our company to an acquirer than other investors, or they may want us to pursue strategies that deviate from the interests of other stockholders.

Participation in this offering by our existing stockholders and their affiliated entities may reduce the public float for our common stock.

To the extent certain of our existing stockholders and their affiliated entities participate in this offering, such purchases would reduce the non-affiliate public float of our shares, meaning the number of shares of our common stock that are not held by officers, directors and principal stockholders. A reduction in the public float could reduce the number of shares that are available to be traded at any given time, thereby adversely impacting the liquidity of our common stock and depressing the price at which you may be able to sell shares of common stock purchased in this offering.

We are an “emerging growth company” and a “smaller reporting company” and, as a result of the reduced disclosure and governance requirements applicable to emerging growth companies and smaller reporting companies, our common stock may be less attractive to investors.

We are an “emerging growth company” as defined in the JOBS Act. For so long as we remain an emerging growth company, we are permitted and intend to rely on exemptions from certain reporting requirements that are applicable to other public companies that are not emerging growth companies, including:

• reduced obligations with respect to financial data, including only being required to present 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 in the assessment of our internal control over financial reporting;

• not being required to comply with any requirement that may be adopted by the Public Company Accounting Oversight Board regarding mandatory audit firm rotation or a supplement to the auditor’s report providing additional information about the audit and the financial statements;

• reduced disclosure obligations regarding executive compensation in our periodic reports, proxy statements and registration statements; and

• not being required to hold a nonbinding advisory vote on executive compensation and stockholder approval of any golden parachute payments not previously approved.

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We cannot predict if investors will find our common stock less attractive because we will 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. We may take advantage of these reporting exemptions until we are no longer an emerging growth company. We will remain an emerging growth company until the earlier of (1) the last day of the fiscal year (a) following the fifth anniversary of the closing of our initial public offering, (b) in which we have total annual gross revenue of at least $1.235 billion, or (c) in which we are deemed to be a large accelerated filer, which means, among other conditions, that 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, and (2) the date on which we have issued more than $1.0 billion in non-convertible debt during the prior three-year period.

Under Section 107(b) of the JOBS Act, emerging growth companies can delay adopting new or revised accounting standards until such time as those standards apply to private companies, and we expect to rely on this exemption. Even after we no longer qualify as an emerging growth company, we may, under certain circumstances, still qualify as a “smaller reporting company,” which would allow us to take advantage of many of the same exemptions from disclosure requirements, including reduced disclosure obligations regarding executive compensation in our periodic reports and proxy statements. We will be able to take advantage of exemptions for so long as our voting and non-voting common stock held by non-affiliates is less than $250 million measured on the last business day of our second fiscal quarter, or our annual revenue is less than $100 million during the most recently completed fiscal year and our voting and non-voting common stock held by non-affiliates is less than $700.0 million measured on the last business day of our second fiscal quarter.

We will have broad discretion in the use of proceeds from this offering and may invest or spend the proceeds in ways with which you do not agree and in ways that may not increase the value of your investment.

We currently intend to use the net proceeds from this offering, together with our existing cash as follows: (i) approximately $ million to advance the development of INVA8001, including the initiation of a Phase 2a trial and the expected data readout for chronic inducible urticaria, subject to CTA filing and clearance; (ii) approximately $ million to advance the pre-clinical development of INVA8003; (iii) $1.8 million to repay a portion of our outstanding indebtedness to InveniAI under the terms of the InveniAI Line of Credit; (iv) approximately $ million to pay certain related party secured promissory notes; (v) approximately $ million to repay, if required, certain convertible notes that are not converted in connection with this offering; (vi) approximately $ million to pay outstanding accrued liabilities, which includes approximately $ million in accrued wages and payroll tax obligations due to our executive officers; (vii) approximately $0.1 million to pay InveniAI for accrued licensing fees under the AlphaMeld License; and (viii) the remainder for general corporate purposes, including working capital, operating expenses and other capital expenditures. See the section titled “Use of Proceeds” for additional information.

Because of the number and variability of factors that will determine our use of the net proceeds from this offering, their ultimate use may vary substantially from their currently intended use. You may not agree with our decisions, and our use of the proceeds may not yield any return on your investment and the failure by our management to apply these funds effectively could harm our business. Our failure to apply the net proceeds from this offering effectively could compromise our ability to pursue our growth strategy and we might not be able to yield a significant return, if any, on our investment of these net proceeds. You will not have the opportunity to influence our decisions on how to use our net proceeds from this offering.

Because we do not anticipate paying any cash dividends on our common stock in the foreseeable future, capital appreciation, if any, will be your sole source of gains and you may never receive a return on your investment.

You should not rely on an investment in our common stock to provide dividend income. We have not declared or paid cash dividends on our common stock to date. We currently intend to retain our future earnings, if any, to fund the development and growth of our business and do not anticipate declaring or paying any cash dividends for the foreseeable future. As a result, capital appreciation, if any, of our common stock will be your sole source of gain for the foreseeable future. Investors seeking cash dividends should not purchase our common stock. There is no guarantee that shares of our common stock will appreciate in value or even maintain the price at which stockholders have purchased their shares.

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Our stock price may not reflect the achievement of our business and strategic goals, and investors may not realize a return on their investment.

The market price of our common stock may fluctuate significantly and may not always correlate with the achievement of our business and strategic objectives. While we are focused on advancing our product candidates, expanding our pipeline, securing regulatory approvals, and executing on our long-term strategy, these accomplishments may not immediately or directly translate into increased stock value.

Stock price movements can be influenced by a variety of factors outside of our control, including macroeconomic conditions, industry trends, investor sentiment, market speculation, short-term financial results, and overall stock market volatility. Additionally, external events such as regulatory decisions, clinical trial developments by competitors, or broader market downturns could impact our stock performance regardless of our operational success.

As a result, investors should be aware that even if we achieve our business and strategic milestones, our stock price may not appreciate accordingly, and investors may not realize a return on their investment. Furthermore, our stock price may be subject to significant volatility, declines, or underperformance relative to industry peers, irrespective of our actual progress in advancing our pipeline and executing our corporate strategy.

Our amended and restated certificate of incorporation provides that the Court of Chancery of the State of Delaware and the federal district courts of the United States of America will be the exclusive forums for substantially all 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 or the underwriters of any offering giving rise to such claim.

Our amended and restated certificate of incorporation provides, and our amended and restated certificate of incorporation that will be in effect immediately prior to the consummation of this offering will provide, that the Court of Chancery of the State of Delaware is the exclusive forum for (1) any derivative action or proceeding brought on our behalf, (2) any action asserting a claim for breach of a fiduciary duty owed by any of our directors, officers or other employees to us or our stockholders, (3) any action asserting a claim arising pursuant to any provision of the Delaware General Corporation Law, our amended and restated certificate of incorporation or our amended and restated bylaws or (4) any action asserting a claim governed by the internal affairs doctrine provided, that, this provision would not apply to suits brought to enforce a duty or liability created by the Exchange Act. Our amended and restated certificate of incorporation further provides, and our amended and restated certificate of incorporation that will be in effect immediately prior to the consummation of this offering will provide, 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. Investors cannot waive compliance with the federal securities laws and the rules and regulations thereunder.

These exclusive forum provisions may limit a stockholder’s ability to bring a claim in a judicial forum that it finds favorable for disputes with us or our directors, officers or other employees, or the underwriters of any offering giving rise to such claim, which may discourage such lawsuits against such parties. For example, stockholders who do bring a claim in the Court of Chancery could face additional litigation costs in pursuing any such claim, particularly if they do not reside in or near the State of Delaware. The Court of Chancery and federal district courts may also reach different judgments or results than would other courts, including courts where a stockholder considering an action may be located or would otherwise choose to bring the action, and such judgments or results may be more favorable to us than to our stockholders. Some companies that adopted a similar federal district court forum selection provision are currently subject to a suit in the Chancery Court of Delaware by stockholders who assert that the provision is not enforceable. If a court were to find either choice of forum provision contained in our amended and restated certificate of incorporation 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.

There is uncertainty as to whether a court would enforce such provisions, and the enforceability of similar choice of forum provisions in other companies’ charter documents has been challenged in legal proceedings. 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 these types of provisions to be inapplicable or unenforceable, and if a court were to find the exclusive forum provision in our amended and restated certificate of incorporation to be inapplicable or unenforceable in an action, we may incur additional costs associated with resolving the dispute in other jurisdictions, which could materially adversely affect our business.

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General Risk Factors

If our information technology systems or data, or those of third parties upon which we rely, are or were compromised, or fail, we could experience adverse consequences resulting from such compromise, or failure, including but not limited to regulatory investigations or actions; litigation; fines and penalties; disruptions of our business operations; reputational harm; loss of revenue or profits; and other adverse consequences.

In the ordinary course of our business, we and the third parties upon which we rely, process, collect, receive, store, use, transfer, protect, secure, dispose of, transmit, and share (collectively referred to as processing) proprietary, confidential, and sensitive data, including personal data (such as health-related data), intellectual property, and trade secrets (collectively referred to as sensitive information). The secure processing, maintenance and transmission of sensitive information is critical to our operations. Despite our security measures, our information technology and infrastructure may be vulnerable to attacks by hackers or breached due to employee error, malfeasance or other disruptions.

Cyber-attacks, malicious internet-based activity, online and offline fraud, security breaches and other similar activities threaten the confidentiality, integrity, and availability of our sensitive information and information technology systems, and those of the third parties upon which we rely. Such threats are prevalent and continue to rise, are increasingly difficult to detect, and come from a variety of sources, including traditional computer “hackers,” threat actors, “hacktivists,” organized criminal threat actors, personnel (such as through theft or misuse), sophisticated nation states, and nation-state-supported actors. Some actors now engage and are expected to continue to engage in cyber-attacks, including without limitation nation-state actors for geopolitical reasons and in conjunction with military conflicts and defense activities.

These risks, as well as the number and frequency of cybersecurity events globally, may also be heightened during times of war or other major conflicts. We and the third parties upon which we rely are subject to a variety of evolving threats, including but not limited to social-engineering attacks (including through phishing attacks), malicious code (such as viruses and worms), malware (including as a result of advanced persistent threat intrusions), denial-of-service attacks (such as credential stuffing attacks), credential harvesting, personnel misconduct or error, ransomware attacks, supply-chain attacks, software bugs, server malfunctions, software or hardware failures, loss of data or other information technology assets, adware, electrical and telecommunications failures, earthquakes, fires, floods, and other similar threats. In particular, severe ransomware attacks are becoming increasingly prevalent and can lead to significant interruptions in our operations, loss of sensitive information and income, reputational harm, and diversion of funds. Extortion payments may alleviate the negative impact of a ransomware attack, but we may be unwilling or unable to make such payments due to, for example, applicable laws or regulations prohibiting such payments.

Remote work has become more common and has increased risks to our information technology systems and data, as more of our employees utilize network connections, computers and devices outside our premises or network, including working at home, while in transit and in public locations.

Future business transactions (such as acquisitions or integrations) could expose us to additional cybersecurity risks and vulnerabilities, as our systems could be negatively affected by vulnerabilities present in acquired or integrated entities’ systems and technologies. Furthermore, we may discover security issues that were not found during due diligence of such acquired or integrated entities, and it may be difficult to integrate companies into our information technology environment and security program.

We currently rely on third-party service providers and technologies to operate critical business systems to process sensitive information in a variety of contexts, including, without limitation, cloud-based infrastructure, employee email, and other functions. We also currently rely on commercially available tools from third-party service providers to process and safeguard our sensitive information and business data. While we are responsible for monitoring these third parties’ information security practices, our influence and ability to conduct in-depth audits of these third parties is limited. If our third-party service providers experience a security incident or other interruption, we could experience adverse consequences. While we may be entitled to damages and other remedies if our third-party service providers fail to satisfy their privacy or security-related obligations to us, any award may be insufficient to cover our damages, or we may be unable to recover such award.

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Although, to our knowledge, we have not experienced any material security breach to date, any of the previously identified or similar threats or system failures could cause a security incident or other interruption that could result in unauthorized, unlawful, or accidental acquisition, modification, destruction, loss, alteration, encryption, disclosure of, or access to our sensitive information or our information technology systems, or those of the third parties upon whom we rely.

Certain data privacy and security obligations may require us to implement and maintain specific security measures or industry-standard or reasonable security measures to protect our information technology systems and sensitive information. While we have implemented security measures designed to protect against security incidents, there can be no assurance that these measures will always be effective.

Additionally, certain federal, state and foreign government requirements include obligations of companies to notify individuals of security breaches involving particular categories of personally identifiable information, which could result from breaches experienced by us or the third parties upon whom we rely. Such disclosures are costly, and the disclosure or the failure to comply with such requirements could lead to adverse consequences.

We may not be able to detect and remediate vulnerabilities in our information technology systems because the threats and techniques used to exploit the vulnerability change frequently and are often sophisticated in nature. Therefore, such vulnerabilities could be exploited but may not be detected until after a security incident has occurred. These vulnerabilities pose material risks to our business. Further, we may experience delays in developing and deploying remedial measures designed to address any such identified vulnerabilities. It is not possible to prevent all threats to our information technology systems and those of our third-party service providers, over which we exert less control, and any controls we implement to do so may prove to be ineffective.

If we (or a third party upon whom we rely) experience a security incident or are perceived to have experienced a security incident, we may experience adverse consequences, such as government enforcement actions (for example, investigations, fines, penalties, audits, and inspections); additional reporting requirements and/or oversight; restrictions on processing sensitive information (including personal data); litigation (including class claims); indemnification obligations; negative publicity; reputational harm; monetary fund diversions; interruptions in our operations (including availability of data); financial loss; and other similar harms. Security incidents and attendant consequences may cause delays or disruptions in our clinical trials and development of product candidates, deter customers from using our products, and negatively impact our ability to grow and operate our business.

Our contracts may not contain limitations of liability, and even where they do, there can be no assurance that limitations of liability in our contracts are sufficient to protect us from liabilities, damages, or claims related to our data privacy and security obligations. We cannot be sure that our insurance coverage will be adequate or sufficient to protect us from or to mitigate liabilities arising out of our privacy and security practices, that such coverage will continue to be available on commercially reasonable terms or at all, or that such coverage will pay future claims. In addition to experiencing a security incident, third parties may gather, collect, or infer sensitive information about us from public sources, data brokers, or other means that reveals competitively sensitive details about our organization and could be used to undermine our competitive advantage or market position.

We are subject to stringent and evolving U.S. laws and regulations and foreign laws, regulations, rules, contractual obligations, policies and other obligations related to data privacy and security. Our actual or perceived failure to comply with such obligations could lead to regulatory investigations or actions; litigation; fines and penalties; disruptions of our business operations; reputational harm; loss of revenue or profits; and other adverse business consequences.

In the ordinary course of business, we process personal data and other sensitive information, including proprietary and confidential business data, trade secrets, intellectual property, data we collect about clinical trial participants and sensitive third-party data. Our data processing activities may subject us to numerous data privacy and security obligations, such as various laws, regulations, guidance, industry standards, external and internal privacy and security policies, contractual requirements, and other obligations relating to data privacy and security.

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In the United States, there are numerous federal and state privacy and data security laws and regulations governing the collection, use, disclosure, transfer, security, and other processing of personal information, including federal and state health information privacy laws, federal and state security breach notification laws, federal and state consumer protection laws (e.g., Section 5 of the Federal Trade Commission Act). In addition, we face litigation and business risks related to the use of cookies and similar tracking technologies. For example, we face litigation risks related to the recent increase in private litigation alleging that the use of cookies and similar tracking technologies without consent violates state laws governing “wiretapping,” “trap and trace,” “pen registers,” and similar laws. Each of these constantly evolving laws can be subject to varying interpretations. Implementation standards and enforcement practices are likely to remain uncertain for the foreseeable future, which may create uncertainty in our business, affect our or our service providers’ ability to operate in certain jurisdictions or to collect, store, transfer use and share personal data, result in liability or impose additional compliance or other costs on us.

For example, HIPAA imposes specific requirements relating to the privacy, security, and transmission of individually identifiable health information. 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. Depending on the facts and circumstances, we could be subject to criminal penalties if we knowingly obtain, use, or disclose individually identifiable health information maintained by a HIPAA-covered entity in a manner that is not authorized or permitted by HIPAA.

Additionally, California enacted the California Consumer Privacy Act of 2018, or the CCPA, which applies to personal information of consumers, business representatives, and employees, and requires businesses subject to the CCPA to, among other requirements, provide specific disclosures in privacy notices and honor requests of California residents to exercise certain privacy rights. The CCPA provides for civil penalties of up to $7,500 (adjusted for inflation) per intentional violation, as well as a private right of action for certain data breaches that allows private litigants to recover significant statutory damages. Although the CCPA exempts some data processed in the context of clinical trials, the CCPA would increase compliance costs and potential liability with respect to other personal data we maintain about California residents, should we become subject to the CCPA in the future.

Further, the California Privacy Rights Act of 2020, or the CPRA, expands the CCPA’s requirements, including by adding a new right for individuals to correct their personal information and establishing a new regulatory agency to implement and enforce the law. Other states, such as Virginia, Colorado, Utah, and Connecticut, have also passed comprehensive consumer privacy laws, and similar laws have been passed or are being considered in several other states. In addition, several states have enacted laws regulating consumer health information, including Washington, which recently enacted the My Health, My Data Act. Privacy laws also exist at the federal and local levels. While many of these state laws, like the CCPA, also exempt certain protected health information that is subject to HIPAA and data processed in the context of clinical trials, these developments further complicate compliance efforts, may impact certain of our business activities, and increase legal risk and compliance costs for us and the third parties upon whom we rely, if and when we become subject to those state laws.

Outside the United States, an increasing number of laws, regulations, and industry standards may govern data privacy and security.

The GDPR harmonizes data protection requirements across the EU member states by establishing new and expanded operational requirements for entities that collect, process or use personal data generated in the EU, including consent requirements for disclosing the way personal information will be used, information retention requirements, and notification requirements in the event of a data breach.

Following Brexit, the United Kingdom’s exit from the European Union on January 31, 2020, the United Kingdom adopted the UK GDPR, which substantially aligns with the EU GDPR, or the UK GDPR. However, there is a risk the EU and UK data protection law diverges in the future, which may increase our overall data protection compliance costs. We are also subject to evolving and strict rules on the transfer of personal data out of the EU and UK to the U.S. Further prospective revision of the Directive on privacy and electronic communications (Directive 2002/58/EC), or ePrivacy Directive, and Privacy and Electronic Communications Regulations 2003 (PECR) in the United Kingdom may affect our marketing communications.

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We have implemented procedures to ensure compliance with the GDPR and UK GDPR and its requirements. Our actual or alleged failure to comply with these regulations, or to protect personal data, could result in enforcement actions and significant penalties against us, which could result in negative publicity, increase our operating costs, subject us to claims or other remedies and have a material adverse effect on our business, financial condition, and results of operations. It is not always possible to identify and deter misconduct by employees or other parties. The precautions we take to detect and prevent such activity may not protect us from legal or regulatory action resulting from a failure to comply with applicable laws or regulations. Misconduct by our employees, CROs, investigators, consultants, commercial partners or vendors could result in significant financial penalties, criminal sanctions, civil law claims and/or negative media coverage, and thus have a material adverse effect on our business, including through the imposition of significant fines or other sanctions, and our reputation. In particular, failure to comply with EU laws, including failure under the GDPR, UK GDPR ePrivacy Directive, PECR and other laws relating to the security of personal data may result in fines up to €20,000,000 or up to 4% of the total worldwide annual turnover of the preceding financial year, if greater, and other administrative penalties or criminal liability, which may be onerous and adversely affect our business, financial condition, results of operations and prospects. Failure to comply with the GDPR, UK GDPR and related laws may also give risk to increase risk of private actions, including a new form of class action that is available under the GDPR and UK GDPR.

Several states, localities and other jurisdictions have enacted measures related to the use of artificial intelligence and machine learning in products and services. For example, in the EU, Regulation 2024/1689, or the EU AI Act, has become applicable in several parts and imposes onerous obligations related to the development and use of certain AI-related systems. Other laws on digital applications and data use have been introduced, including Regulation 2023/1828, or the EU Data Act, which was adopted in 2023 and entered into application in September 2025, with some staged obligations. Recently, the European Commission has proposed the “digital omnibus” initiative, which aims to simplify and partially relax the GDPR and related digital laws and reduce administrative burdens. However, it is currently unclear what changes will be made, and if or when the proposed digital omnibus initiative may become law.

We are also bound by contractual obligations related to data privacy and security, and our efforts to comply with such obligations may not be successful. If any privacy policies, marketing materials or other statements regarding data privacy and security that we publish are found to be deficient, lacking in transparency, deceptive, unfair, or misrepresentative of our practices, we may be subject to investigation, enforcement actions by regulators, including the Federal Trade Commission, or other adverse consequences.

Obligations related to data privacy, security, and AI are quickly changing, becoming increasingly stringent, and creating regulatory uncertainty. Additionally, these obligations may be subject to differing applications and interpretations, which may be inconsistent or conflict among jurisdictions. Preparing for and complying with these obligations requires us to devote significant resources, which may necessitate changes to our services, information technologies, systems, and practices and to those of any third parties that process personal data on our behalf. In addition, these obligations may require us to change our business model.

We may at times fail (or be perceived to have failed) in our efforts to comply with our data privacy and security obligations. Moreover, despite our efforts, our personnel or third parties on whom we rely may fail to comply with such obligations, which could create legal risks and negatively impact our business operations. If we or the third parties we rely on fail, or are perceived to have failed, to address or comply with applicable data privacy and security obligations, we may face significant consequences, including but not limited to: government enforcement actions (e.g., investigations, fines, penalties, audits, inspections, and similar); litigation (including class-action claims); additional reporting requirements and/or oversight; bans on processing personal data; orders to destroy or not use personal data; and imprisonment of company officials. Any of these events could have a material adverse effect on our reputation, business, or financial condition, including but not limited to: loss of customers; interruptions or stoppages in our business operations (including, as relevant, clinical trials and development of product candidates); inability to process personal data or to operate in certain jurisdictions; limited ability to develop or commercialize our products; expenditure of time and resources to defend any claim or inquiry; adverse publicity; or substantial changes to our business model or operations.

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Our business activities will be subject to the Foreign Corrupt Practices Act and similar anti-bribery and anti-corruption laws.

As we expand our business activities outside of the United States, including our clinical trial efforts, we will be subject to various anti-corruption laws and regulations, including the U.S. Foreign Corrupt Practices Act of 1977, as amended, or the FCPA, the U.S. domestic bribery statute contained in 18 U.S.C. § 201, the U.S. Travel Act, and other state and national anti-bribery and anti-money laundering laws in the countries in which we operate. Anti-corruption laws, including the FCPA, generally prohibit companies and their employees, agents, CROs, contractors and other collaborators and partners from offering, promising, giving, soliciting, or authorizing others to give or receive anything of value, either directly or indirectly, to or from a non-United States government official in order to influence official action, or otherwise obtain or retain business. The FCPA also requires public companies to make and keep books and records that accurately and fairly reflect the transactions of the corporation and to devise and maintain an adequate system of internal accounting controls. Our business is heavily regulated and therefore involves significant interaction with public officials, including officials of non-United States governments. Additionally, healthcare providers and doctors of state-owned or controlled entities, such as hospitals, universities, and research institutions, are also considered public officials under the FCPA. We may engage third parties to sell our products outside the United States, to conduct clinical trials, and/or to obtain necessary permits, licenses, patent registrations, and other regulatory approvals. We have direct or indirect interactions with officials and employees of government agencies or government-affiliated hospitals, universities, and other organizations. There is no certainty that all of our employees, agents, suppliers, manufacturers, CROs, contractors, or collaborators, or those of our affiliates, will comply with all applicable laws and regulations, particularly given the high level of complexity of these laws. We can be held liable for the corrupt or other illegal activities of our employees, agents, contractors, and other collaborators, even if we do not explicitly authorize or have actual knowledge of such activities. Violations of these laws and regulations could result in fines, criminal sanctions against us, our officers, or our employees, the closing down of facilities, including those of our suppliers and manufacturers, implementation of compliance programs, and prohibitions on the conduct of our business. Any such violations could include prohibitions on our ability to offer our products in one or more countries as well as difficulties in manufacturing or continuing to develop our products, and could materially damage our reputation, our brand, our international expansion efforts, our ability to attract and retain employees, and our business, prospects, operating results, and financial condition.

We are subject to laws and regulations governing exports, imports, trade and economic sanctions, with which our compliance is required and that could affect our cross-border operations. Non-compliance with these laws and regulations could result in legal liability for us.

We are subject to and required to comply with various export controls, customs rules on imports, and trade and economic sanctions laws and regulations, including the U.S. Export Administration Regulations, U.S. Customs regulations, and sanctions regulations administered by the U.S. Treasury Department’s Office of Foreign Assets Control, or, collectively, Trade Control Laws. Trade Control Laws may prohibit or restrict our ability to import products, export, reexport, transfer, or otherwise release products, or provide services without authorization. To the extent required, regulatory licensing requirements can hinder product lead time, and authorization is not guaranteed.

Changes in Trade Control Laws, which are dynamic, or to our product candidates may create delays in the introduction, provision, or sale of our product candidates in international markets, prevent customers from using our product candidates or, in some cases, prevent the export or import of our product candidates to certain countries, governments or persons altogether. Any limitation on our ability, or the ability of our partners, to export, provide, or sell our product candidates could adversely affect our supply chain and our business, financial condition, and results of operations.

Compliance with applicable Trade Control Laws can be time-and resource-intensive. We are in the process of adopting policies and procedures designed to achieve compliance, but we cannot guarantee application of Trade Control Laws to our operations will never result in possible compliance issues. Violations of applicable Trade Controls Laws are aggressively enforced, and can result in significant financial penalties, imprisonment of responsible personnel, loss of licensing privileges, other administrative penalties, reputational harm, and adverse business impact.

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If we fail to maintain proper and effective internal controls, our ability to produce accurate financial statements on a timely basis could be impaired.

After the closing of this offering, we will be subject to the reporting requirements of the Exchange Act, the Sarbanes-Oxley Act of 2002, or the Sarbanes-Oxley Act, and the rules and regulations of the stock market on which our common stock is listed. The Sarbanes-Oxley Act requires, among other things, that we maintain effective disclosure controls and procedures and internal control over financial reporting.

Commencing with our fiscal year ending December 31, 2025, we must perform system and process evaluation and testing of our internal control over financial reporting to allow management to report on the effectiveness of our internal control over financial reporting in our Form 10-K filing for that year, as required by Section 404 of the Sarbanes-Oxley Act. This will require that we incur substantial additional professional fees and internal costs to expand our accounting and finance functions and that we expend significant management efforts. Prior to this offering, we have never been required to test our internal control within a specified period, and, as a result, we may experience difficulty in meeting these reporting requirements in a timely manner. In addition, when we lose our status as an “emerging growth company” and if we do not otherwise qualify as a “smaller reporting company,” our independent registered public accounting firm will be required to attest to the effectiveness of our internal control over financial reporting, which will require additional expense, resources and management commitment.

We may identify material weaknesses in our system of internal financial and accounting controls and procedures that could result in a material misstatement of our financial statements. Our internal control over financial reporting will not prevent or detect all errors and all fraud. A control system, no matter how well designed and operated, can provide only reasonable, not absolute, assurance that the control system’s objectives will be met. Because of the inherent limitations in all control systems, no evaluation of controls can provide absolute assurance that misstatements due to error or fraud will not occur or that all control issues and instances of fraud will be detected.

If we are not able to comply with the requirements of Section 404 of the Sarbanes-Oxley Act in a timely manner, or if we are unable to maintain proper and effective internal controls over financial reporting, we may not be able to produce timely and accurate financial statements. If that were to happen, the market price of our stock could decline and we could be subject to sanctions or investigations by the stock exchange on which our common stock is listed, the SEC, or other regulatory authorities.

The United Kingdom’s withdrawal from the European Union continues to impact regulatory frameworks, trade, and economic conditions, which may affect our business.

The United Kingdom formally left the European Union on January 31, 2020 (commonly referred to as Brexit), with the transition period ending on December 31, 2020. While the UK-EU Trade and Cooperation Agreement, or the TCA, was established to govern future trade relations and was fully implemented on May 1, 2021, the long-term implications of Brexit continue to evolve, impacting regulatory frameworks, trade flows, and market dynamics. Since a significant proportion of the regulatory framework in the United Kingdom applicable to our business and our product candidates was historically derived from European Union directives and regulations, post-Brexit regulatory divergence has created additional complexities in the development, manufacturing, importation, approval, and commercialization of our product candidates in the UK and EU.

For example, Great Britain (England, Scotland, and Wales) is no longer covered by the centralized procedures for obtaining European Union-wide marketing and manufacturing authorizations from the EMA. A separate process for regulatory approvals through the MHRA is now required. While the UK has introduced regulatory pathways such as international recognition routes, or IRR, to expedite approvals, these pathways remain subject to periodic review and policy changes, creating potential uncertainties for our regulatory strategy. Although the TCA provides for tariff-free trade of medicinal products between the UK and the EU, new regulatory requirements, customs procedures, and border checks have led to increased administrative costs, supply chain disruptions, and potential delays in the transit of pharmaceutical goods. These non-tariff barriers have affected trade efficiency and could impact the availability of key components, active pharmaceutical ingredients, or APIs, and other critical materials required for drug development and commercialization.

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Additionally, Brexit-related regulatory divergence has introduced uncertainty regarding future pharmaceutical pricing, market access, and intellectual property protections in the UK, as the country adapts its post-EU regulatory framework. The UK has also opted out of certain EU-wide initiatives, such as the European Health Emergency Preparedness and Response Authority and the EMA’s accelerated assessment processes, which could impact access to emergency-use authorizations and expedited drug approvals. The ongoing effects of Brexit may require us to modify our regulatory strategies, adapt supply chain logistics, or increase operational expenditures to comply with dual regulatory regimes in the EU and UK. Any delays in obtaining UK marketing approvals or disruptions to cross-border trade could negatively impact our ability to commercialize our product candidates, generate revenue, or achieve profitability. Furthermore, any future changes in UK-EU trade relations, tariff policies, or supply chain regulations could impose additional costs, complexities, or restrictions on our ability to conduct business in either market.

We might not be able to utilize a significant portion of our net operating loss carryforwards.

We have generated and expect to continue to generate significant federal and state net operating loss, or NOL, carryforwards in the future. As of December 31, 2024 and 2023, we had federal and state NOLs of $11.3 million and $6.4 million, respectively. Under current tax regulations, these NOL carryforwards could expire unused and be unavailable to offset future income tax liabilities. Under the Tax Cuts and Jobs, or the Tax Act, as modified by the Coronavirus Aid, Relief, and Economic Security Act, or the CARES Act, federal NOLs incurred in taxable years beginning after December 31, 2017 may be carried forward indefinitely, but the deductibility of such federal NOLs is limited.

In addition, under Section 382 of the Internal Revenue Code of 1986, as amended, or the Code, and corresponding provisions of state law, if a corporation undergoes an “ownership change,” which is generally defined as a greater than 50% change, by value, in its equity ownership over a three-year period, the corporation’s ability to use its pre-change NOL carryforwards and other pre-change tax attributes to offset its post-change income or taxes may be limited. Sales of our common stock by our existing stockholders, or additional sales of our common stock by us, could trigger additional limitations under Section 382 and have a material adverse effect on our results of operations in future years. There is also a risk that due to regulatory changes, such as suspensions on the use of NOLs by federal or state taxing authorities or other unforeseen reasons, portions of our existing NOLs could expire or otherwise be unavailable to reduce future income tax liabilities.

New tax laws or regulations, changes to existing tax laws or regulations or changes in their application to us or our customers may have a material adverse effect on our business, cash flows, financial condition or results of operations.

U.S. federal, state, local and foreign tax laws, regulations and administrative guidance are subject to change as a result of the legislative process and review and interpretation by the U.S. Internal Revenue Service, the U.S. Treasury Department and other taxing authorities. Changes to tax laws (which changes may have retroactive application), including with respect to net operating losses and research and development tax credits, could adversely affect us or holders of our common stock. In recent years, many such changes have been made and changes are likely to continue to occur in the future. Future changes in tax laws could have a material adverse effect on our business, cash flow, financial condition or results of operations. We urge investors to consult with their legal and tax advisers regarding the implications of potential changes in tax laws on an investment in our common stock.

We will incur increased costs and demands upon management as a result of being a public company.

As a public company listed in the United States, we will be subject to the reporting requirements of the Exchange Act, which will require, among other things, that we file with the SEC annual, quarterly and current reports with respect to our business and financial condition. In addition, Sarbanes-Oxley, as well as rules subsequently adopted by the SEC and Nasdaq to implement provisions of Sarbanes-Oxley, impose significant requirements on public companies, including requiring establishment and maintenance of effective disclosure and financial controls and certain corporate governance practices. Further, pursuant to the Dodd-Frank Wall Street Reform and Consumer Protection Act of 2010, the SEC has adopted additional rules and regulations in these areas, such as mandatory “say on pay” voting requirements that will apply to us when we cease to be an emerging growth company. As a result, we will incur significant additional legal, accounting and other costs. These additional costs could negatively affect our financial results.

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In addition, changing laws, regulations and standards relating to corporate governance and public disclosure, including regulations implemented by the SEC and The Nasdaq Stock Market, may increase legal and financial compliance costs and make some activities more time-consuming. These laws, regulations and standards are subject to varying interpretations and, as a result, their application in practice may evolve over time as new guidance is provided by regulatory and governing bodies. We intend to invest resources to comply with evolving laws, regulations and standards, and this investment may result in increased general and administrative expenses and a diversion of management’s time and attention from revenue-generating activities to compliance activities. If notwithstanding our efforts to comply with new laws, regulations and standards, we fail to comply, regulatory authorities may initiate legal proceedings against us and our business may be harmed.

Failure to comply with these rules might also make it more difficult for us to obtain some types of insurance, including director and officer liability insurance, and we might be forced to accept reduced policy limits and coverage or incur substantially higher costs to obtain the same or similar coverage. The impact of these events could also make it more difficult for us to attract and retain qualified persons to serve on our board of directors, on committees of our board of directors or as members of senior management.

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SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS

This prospectus contains forward-looking statements that involve substantial risks and uncertainties. The forward-looking statements are contained principally in the sections titled “Prospectus Summary,” “Risk Factors,” “Management’s Discussion and Analysis of Financial Condition and Results of Operations,” “Business” and elsewhere in this prospectus. All statements, other than statements of historical fact, contained in this prospectus, including statements regarding our strategy, future operations, future financial position, future revenue, projected costs, prospects, product candidates, planned preclinical studies and clinical trials, results of preclinical studies and clinical trials, research and development costs, regulatory approvals, timing and likelihood of success, as well as plans and objectives of management, are forward-looking statements. In some cases, you can identify forward-looking statements by words such as “anticipate,” “believe,” “contemplate,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “might,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” “would” or the negative of these words or other similar expressions, although not all forward-looking statements contain these identifying words. These statements speak only as of the date of this prospectus and involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. We have based these forward-looking statements largely on our current expectations and projections about future events and financial and other trends that we believe may affect our business, financial condition and results of operations.

The forward-looking statements in this prospectus include, among other things, statements about:

• our ability to continue as a going concern;

• the anticipated timing, progress and results of our preclinical studies and clinical trials of our product candidates, including our expectations regarding the protocol and effectiveness of our planned design of the INVA80001 clinical trial, statements regarding the timing of initiation and completion of studies or trials and related preparatory work, the period during which the results of the trials will become available and our research and development programs;

• our expectations about the safety, effectiveness and commercial viability of our product candidates;

• the timing of the planned CTA submissions, initiation of clinical trials and timing of expected clinical results for INVA8001, INVA8003 and our other future product candidates;

• the timing of any submission of filings for regulatory approval of, and our ability to obtain and maintain regulatory approvals for, our current and future product candidates;

• our expectations regarding the size of the patient populations, market acceptance and opportunity for and clinical utility of our product candidates, if approved for commercial use;

• our manufacturing capabilities and strategy, including the scalability and commercial viability of our manufacturing methods and processes;

• our expectations regarding the scope of any approved indication for INVA8001, INVA8003 or any other product candidate;

• our ability to successfully commercialize our product candidates;

• our ability to leverage the AI technology of the AlphaMeld Platform to identify and nominate future product candidates, or our ability to in-license or design future product candidates;

• our estimates of our expenses, ongoing losses, future revenue, capital requirements;

• our ability to obtain additional funding for our operations, including funding necessary to complete our development and commercialization efforts of our product candidates;

• our ability to establish or maintain collaborations or strategic relationships;

• our ability to identify, recruit and retain key personnel;

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• our ability to protect and enforce our intellectual property position for our product candidates, and the scope of such protection;

• our financial performance;

• our competitive position and the development of and projections relating to our competitors or our industry;

• the impact of existing laws and regulations and legal and regulatory developments in the United States and other jurisdictions;

• our ability to expand our pipeline of product candidates;

• our expectations regarding the impact of geopolitical uncertainty, including rising interest rates, tariffs and inflation, on our business and operations, including preclinical studies and clinical trials, collaborators and employees;

• our expected use of the net proceeds from this offering and the sufficiency of our existing cash to fund our future operating expenses and capital expenditure requirements; and

• our expectations regarding the time during which we will be an emerging growth company under the JOBS Act.

These forward-looking statements speak only as of the date of this prospectus. Except as required by applicable law, we do not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise. You should, however, review the factors and risks and other information we describe in the reports we will file from time to time with the SEC after the date of this prospectus. See the section titled “Where You Can Find More Information.”

Because forward-looking statements are inherently subject to risks and uncertainties, some of which cannot be predicted or quantified and some of which are beyond our control, you should not rely on these forward-looking statements as predictions of future events. Although we believe that we have a reasonable basis for each forward-looking statement contained in this prospectus, the events and circumstances reflected in our forward-looking statements may not be achieved or occur and actual results could differ materially from those projected in the forward-looking statements. You should refer to the “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” sections of this prospectus for a discussion of important factors that may cause our actual results to differ materially from those expressed or implied by our forward-looking statements. Moreover, we operate in an evolving environment. New risk factors and uncertainties may emerge from time to time, and it is not possible for management to predict all risk factors and uncertainties. As a result of these factors, we cannot assure you that the forward-looking statements in this prospectus will prove to be accurate.

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

You should read this prospectus and the documents that we reference in this prospectus and have filed as exhibits to the registration statement, of which this prospectus is a part, completely and with the understanding that our actual future results may be materially different from what we expect. We qualify all of our forward-looking statements by these cautionary statements.

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MARKET AND INDUSTRY DATA

We obtained the industry, statistical and market data in 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. The content of these third-party sources, except to the extent specifically set forth in this prospectus, does not constitute a portion of this prospectus and is not incorporated herein.

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 our industry and market, which we believe to be reasonable. 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.

All of the market data used in this prospectus involve a number of assumptions and limitations, and the sources of such data cannot guarantee the accuracy or completeness of such information. While we are not aware of any misstatements regarding the third-party information and we believe that each of these studies and publications is reliable, the industry in which we operate is subject to a high degree of uncertainty and risk due to a variety of important factors, including those described in the sections titled “Risk Factors,” “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and “Special Note Regarding Forward-Looking Statements.” These and other factors could cause results to differ materially from those expressed in the estimates made by third parties and by us.

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USE OF PROCEEDS

We estimate that the net proceeds from our issuance and sale of shares of our common stock in this offering will be approximately $ million (or approximately $ million if the underwriters exercise in full their option to purchase up to additional shares), assuming an initial public offering price of $ per share, which is the midpoint of the 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.

Each $1.00 increase (decrease) in the assumed initial public offering price of $ per share would increase (decrease) the net proceeds to us from this offering by approximately $ 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. Each increase (decrease) of 1.0 million in the number of shares we are offering would increase (decrease) the net proceeds to us from this offering, after deducting the estimated underwriting discounts and commissions and estimated offering expenses payable by us, by approximately $ million, assuming the assumed initial public offering price stays the same. We do not expect that a change in the offering price or the number of shares by these amounts would have a material effect on our intended uses of the net proceeds from this offering, although it may impact the amount of time prior to which we may need to seek additional capital. As of , 2025, we had approximately $ million of cash on hand. We intend to use the net proceeds from this offering, together with our existing cash, as follows:

• approximately $ million to advance the development of INVA8001, including the initiation of a Phase 2a trial and the expected data readout for chronic inducible urticaria, subject to CTA filing and clearance;

• approximately $ million to advance the pre-clinical development of INVA8003;

• $1.8 million to repay a portion of our outstanding indebtedness to InveniAI under the terms of the InveniAI Line of Credit, of which $10.0 million was outstanding, inclusive of principal and interest, and which had an interest rate equal to the applicable federal rate for short-term loans as of September 30, 2025;

• approximately $ million to repay both the 2024 Trust Note due by May 27, 2026 and the October 2024 Secured Notes due by April 22, 2026 and April 28, 2026, of which $0.4 million and $0.2 million, respectively was outstanding, and which had an interest rate of 14.5% and 9.5%, respectively as of September 30, 2025;

• approximately $ million to repay, if required and not converted in connection with this offering, the July 2025 Senior Note due by September 1, 2026, of which $1.2 million was outstanding and had an interest rate of 10% as of September 30, 2025;

• approximately $ million to repay, if required and not converted in connection with this offering, the March 2025 Notes due by December 31, 2025, of which $0.3 million was outstanding and had an interest rate of 18% as of September 30, 2025;

• approximately $ million to pay outstanding accrued liabilities;

• $0.1 million to pay InveniAI for accrued licensing fees, which are comprised of the $50,000 annual subscription fee per annual subscription term effective since January 1, 2024 payable following the successful completion of our initial public offering, under the AlphaMeld License; and

• the remainder for general corporate purposes, including working capital, operating expenses and other capital expenditures.

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Interest on the InveniAI Line of Credit accrues at a rate per annum equal to the applicable federal rate for short-term loans as of the date thereof. Pursuant to the InveniAI Line of Credit, (i) $1.8 million of the principal and all accrued interest thereon is due on the earlier of (a) December 31, 2026 or (b) the completion of this offering with aggregate gross proceeds of at least $20.0 million. The remaining unpaid principal and accrued interest outstanding, including any additional advances or borrowings, shall automatically convert into shares of common stock in this offering or is payable in full on or before June 30, 2027 in the event it is not converted.

On September 20, 2023, the Company entered into the Secured Nandabalan Note for a principal amount of $0.3 million. The Secured Nandabalan Note accrued interest at a rate of 15% per annum, calculated based on a 365/366-day year, as applicable, and actual days elapsed. Additionally, pursuant to the terms of the Secured Nandabalan Note, if any amount payable was not paid when due, whether at stated maturity, by acceleration, or otherwise, such overdue amount would bear interest at 20% per annum. The Secured Nandabalan Note was amended on September 19, 2024, and on October 28, 2025, and was to mature on March 31, 2026. As of September 30, 2025, we owed approximately $0.4 million inclusive of principal and interest on the Secured Nandabalan Note.

On January 31, 2025, the Company entered into the January 2025 Convertible Note for a principal sum of $0.15 million at an interest rate of 12% per annum. The January 2025 Convertible Note had a mandatory automatic conversion feature upon the Company receiving aggregate proceeds of at least $20.0 million in an equity financing. The conversion price was to be determined pursuant to a contractual formula that would result in a price per share that would be lower than the price paid by new investors in such financing. If not converted, all principal and accrued interest would be paid by February 1, 2026. As of September 30, 2025, we owed approximately $0.16 million inclusive of principal and interest on the January 2025 Convertible Note. The Company used the indebtedness accrued pursuant to the January 2025 Convertible Note to primarily fund its IPO-related expenses and for general corporate purposes.

On November 1, 2025, the Company entered into the Consolidated Note in the principal amount of approximately $0.6 million. The Consolidated Note amended, restated, and replaced (i) the Secured Nandabalan Note and (ii) the January 2025 Convertible Note. The Consolidated Note bears interest at 7.5% per annum, matures on December 31, 2026, and contains a mandatory conversion feature into shares of capital stock upon the occurrence of the Company receiving aggregate cash proceeds of at least $10.0 million in a financing event to third parties. The Consolidated Note is unsecured, and all liens granted under the prior notes were released in connection with the entry into the Consolidated Note. The Company used the indebtedness accrued pursuant to the Consolidated Note to consolidate and replace the Secured Nandabalan Note and the January 2025 Convertible Note.

On May 28, 2024, the Company entered into the 2024 Trust Note for a principal amount of $0.35 million, which was amended on September 29, 2025. The 2024 Trust Note accrues interest at a rate of 9.5% per annum, calculated based on a 365/366-day year, as applicable, and actual days elapsed. Additionally, pursuant to the terms of the 2024 Trust Note, if any amount payable is not paid when due, whether at stated maturity, by acceleration, or otherwise, such overdue amount will bear interest at 14.5% per annum. to the 2024 Trust Note matures on May 27, 2026. As of September 30, 2025, we owed approximately $0.4 million inclusive of principal and interest on the 2024 Trust Note. The Company used the indebtedness accrued pursuant to the 2024 Trust Note for general working capital.

On October 23, 2024, and October 29, 2024, respectively, the Company entered into the October 2024 Secured Notes for a principal amount of approximately $0.195 million. The October 2024 Secured Notes accrue interest at a rate that is 9.5% per annum, calculated based on a 365/366-day year, as applicable, and actual days elapsed. Additionally, pursuant to the terms of the October 2024 Secured Notes, if any amount payable is not paid when due, whether at stated maturity, by acceleration, or otherwise, such overdue amount will bear interest at 14.5%. On October 17, 2025, the October 2024 Secured Notes were amended such that the respective principal amount and all accrued and unpaid interest thereunder shall be due and payable on April 22, 2026 for the October 2024 Secured Note with a principal amount of $0.165 million and April 28, 2026 for the October 2024 Secured Note with a principal amount of $0.03 million. As of September 30, 2025, we owed approximately $0.2 million inclusive of principal and interest on the October 2024 Secured Notes. The Company used the indebtedness accrued pursuant to the October 2024 Secured Notes to primarily fund its IPO-related expenses and for general corporate purposes.

On March 31, 2025, the Company issued the March 2025 Notes for a total principal amount of $0.3 million, which were amended on October 27, 2025, and October 29, 2025, respectively. The amendments increased the principal amount of each March 2025 Note from $0.15 million to $0.165 million, for a total principal amount of $0.33 million. The March 2025 Notes bear interest at 18% per annum and mature on December 31, 2025, unless earlier converted or

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extended by the holder. At the option of the holders, the March 2025 Notes are convertible into the same class of equity securities issued in the Company’s next qualified equity financing where the Company raises at least $10.0 million at a 30% discount to the price paid by new investors. If a non-qualified financing occurs, the holder may elect to treat it as a qualified financing for conversion purposes. As of September 30, 2025, the outstanding principal and accrued interest totaled $0.3 million on the March 2025 Notes. The Company used the indebtedness accrued pursuant to March 2025 Notes to primarily fund its IPO-related expenses and for general corporate purposes.

On July 2, 2025, the Company issued the July 2025 Senior Note with an aggregate principal amount of $1.1 million for gross cash proceeds of $0.95 million. The difference between the face value and cash proceeds represents an original issue discount of $0.12 million. The July 2025 Senior Note bears interest at 10% per annum, matures on September 1, 2026, and is convertible, at the holder’s option, into shares of the Company’s common stock at a conversion price equal to 70% of the price per share paid by investors in the Company’s initial public offering or 70% of the price per share implied by the valuation of the Company at the closing of a direct listing of the Company’s securities on a trading market, a reverse takeover or a business combination with a special purpose acquisition company or, if no such transaction has occurred, $4.80 per share, subject to adjustment for stock splits and similar events. The July 2025 Senior Note includes customary covenants and events-of-default provisions and is secured by substantially all the Company’s assets. As of September 30, 2025, we owed approximately $1.2 million inclusive of principal and interest on the July 2025 Senior Note. The Company used the indebtedness accrued pursuant to the July 2025 Senior Note to fund IPO-related expenses, drug manufacturing and pre-clinical experiments for INVA8001, and for general corporate purposes.

On November 19, 2025, the Company issued the November 2025 Senior Note, with an aggregate principal amount of approximately $0.37 million for gross cash proceeds of $0.3 million. The difference between the face value and cash proceeds represents an original issue discount of approximately $0.07 million. The November 2025 Senior Note bears interest at 10% per annum, matures on the earlier of (i) August 19, 2026 or (ii) the closing date of the Company’s initial public offering, and is convertible at the holder’s option into shares of the Company’s common stock at a conversion price equal to 70% of the price per share paid by investors in the Company’s initial public offering or 70% of the price per share implied by the valuation of the Company at the closing of a direct listing of the Company’s securities on a trading market, a reverse takeover or a business combination with a special purpose acquisition company or, if no such transaction has occurred, $4.81 per share, subject to adjustment for stock splits and similar events. The November 2025 Senior Note includes customary covenants and events-of-default provisions and is secured by substantially all the Company’s assets. The Company used the indebtedness accrued pursuant to the November 2025 Senior Note to fund IPO-related expenses and for general working capital.

Based on our current operational plans and assumptions, we believe that the net proceeds of this offering, together with our existing cash, will enable us to fund our operations through . We have based these estimates on assumptions that may prove to be wrong, and we could use our available capital resources sooner than we expect.

We may also use a portion of the remaining net proceeds to in-license, acquire or invest in complementary businesses, technologies, products or assets, although we have no current agreements, commitments or understandings to do so.

This expected use of net proceeds from this offering and our existing cash represents our intentions based upon our current plans and business conditions, including our plans to prepare and submit a CTA for INVA8001, conduct a Phase 2a trial in the EU, and continue developing INVA8003, which could change in the future as our plans and business conditions and/or regulatory requirements evolve. The amounts and timing of our actual expenditures may vary significantly depending on numerous factors, including the progress of our development, the status of and results from preclinical studies and clinical trials, as well as any collaborations that we may enter into with third parties for our product candidates, and any unforeseen cash needs. As a result, our management will have broad discretion in the application of the net proceeds from this offering, and investors will be relying on the judgment of our management regarding the application of those net proceeds. The timing and amount of our actual expenditures will be based on many factors, including cash flows from operations and the anticipated growth of our business. Pending our use of the net proceeds from this offering, we intend to invest the net proceeds in a variety of capital preservation investments, including short-term, investment-grade, interest-bearing instruments and United States government securities.

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DIVIDEND POLICY

We have never paid or declared any cash dividends on our common stock, and we do not anticipate paying any cash dividends on our common stock in the foreseeable future. We currently intend to retain all available funds and any future earnings to support our operations and fund the development and expansion of our business. Any future determination to pay dividends will be at the discretion of our board of directors and will depend upon a number of factors, including our results of operations, financial condition, capital requirements, future prospects, restrictions imposed by contract and applicable law and other factors our board of directors may deem relevant, and subject to applicable laws and the restrictions contained in any future financing instruments.

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CAPITALIZATION

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

• on an actual basis;

• on a pro forma basis, giving effect to (i) the conversion of all the outstanding shares of our preferred stock as of September 30, 2025, including 7,250,000 shares of our Series A preferred stock and 1,092,707 shares of our Series A-1 preferred stock, into an aggregate of shares of common stock upon the closing of this offering, (ii) the issuance of shares of our common stock upon the conversion of $1.2 million of the CEO SAFEs issued by us to our CEO and an affiliate of our CEO in March 2023, (iii) the issuance of shares of common stock upon the conversion of our approximately $ million of certain related party convertible debt instruments, with mandatory conversion features, which will occur upon the closing of this offering assuming an initial public offering price of per share which is the midpoint of the price range set forth on the cover page of this prospectus which will occur upon the closing of this offering, (iv) additional borrowings of $ million under the InveniAI Line of Credit, subsequent to September 30, 2025 and (v) the filing and effectiveness of our amended and restated certificate of incorporation immediately prior to the closing of this offering;

• on a pro forma as adjusted basis giving effect to (i) the pro forma adjustments described above, (ii) the repayment of approximately $1.8 million of aggregate indebtedness under the InveniAI Line of Credit and certain secured related party promissory notes using a portion of the net proceeds of this offering, (iii) the repayment of approximately $ million of convertible debt, which may not convert in connection with this offering, (iv) the payment of approximately $ million to settle outstanding accrued liabilities, and (v) our sale and issuance of shares of our common stock in this offering at an assumed initial public offering price of $ per share, which is the midpoint of the price range set forth on the cover page of this prospectus, after deducting the estimated underwriting discounts and commissions and estimated offering expenses payable by us.

The pro forma and pro forma as adjusted information below is illustrative only. Our capitalization following the closing of this offering will depend on the actual initial public offering price and other terms of this offering determined at pricing. You should read this information in conjunction with our financial statements and the related notes appearing at the end of this prospectus, the sections of this prospectus titled “Summary Financial Data” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and other financial information contained in this prospectus.

	As of September 30, 2025
	Actual		Pro Forma		Pro Forma, As Adjusted(1)
	(in thousands, except share and per share data)
Cash	$	329	$		$
Debt
Series A convertible preferred stock, par value $0.0001 per share, 8,000,000 shares authorized, 7,250,000 issued and outstanding actual: no shares authorized, issued and outstanding, pro forma and pro forma adjusted		538		—		—
Series A-1 convertible preferred stock, par value $0.0001 per share, 3,200,000 shares authorized, 1,092,707 shares issued and outstanding, actual: no shares authorized, issued and outstanding, pro forma and pro forma adjusted		5,117		—		—
Stockholders’ (deficit) equity:
Preferred stock, $0.0001 par value; no shares authorized, issued or outstanding, actual; 10,000,000 shares authorized and no shares issued or outstanding, pro forma and pro forma as adjusted		—		—		—

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	As of September 30, 2025
	Actual			Pro Forma	Pro Forma, As Adjusted(1)
	(in thousands, except share and per share data)
Common stock, $0.0001 par value; 16,980,000 shares authorized, 2,791,750 shares issued and outstanding, actual; 500,000,000 shares authorized, pro forma and pro forma as adjusted, shares issued and outstanding, pro forma; shares issued and outstanding, pro forma as adjusted		—
Additional paid-in capital		4,065
Accumulated deficit		(26,819	)
Total stockholders’ deficit		(22,754	)
Total capitalization	$	(17,099)		$	$

____________

(1) Each $1.00 increase (decrease) in the assumed initial public offering price of $ per share, which is the midpoint of the price range set forth on the cover page of this prospectus, would increase (decrease) the pro forma as adjusted amount of each of cash, additional paid-in capital, total stockholders’ equity and total capitalization by approximately $ 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 and estimated offering expenses payable by us. Similarly, each increase (decrease) of 1.0 million shares in the number of shares offered by us at the assumed initial public offering price per share of $ per share, which is the midpoint of the price range set forth on the cover page of this prospectus, would increase (decrease) the pro forma as adjusted amount of each of cash, additional paid-in capital, total stockholders’ equity and total capitalization by approximately $ million.

If the underwriters’ option to purchase additional shares is exercised in full, our pro forma as adjusted cash, additional paid-in capital, total stockholders’ (deficit) equity and total capitalization as of September 30, 2025, would be $ , $ , $ and $ , respectively.

The number of shares of our common stock outstanding in the table above excludes:

• 4,345,250 shares of our common stock issuable upon exercise of stock options under our 2021 Plan, outstanding as of September 30, 2025 with a weighted average exercise price of $1.39 per share;

• 53,000 shares of our common stock reserved for future issuance under the 2021 Plan as of September 30, 2025;

• 223,170 shares of our common stock issuable upon exercise of warrants issued in connection with our July 2025 Senior Note outstanding as of September 30, 2025 with an exercise price of $4.81 per share;

• 101,061 shares of our common stock issuable upon exercise of warrants issued after September 30, 2025 with an exercise price of $4.81 per share;

• convertible notes in the aggregate principal amount of $ million which will not automatically convert into shares of our common stock in this offering;

• shares of our common stock reserved for future issuance under the 2025 Plan (of which we will grant options to purchase an aggregate of shares of our common stock to certain of our employees and non-employee directors upon the pricing of this offering at an exercise price equal to the initial public offering price) plus a number of shares of common stock not to exceed (consisting of the number of shares that remain available under the 2021 Plan as of immediately prior to the effective date of the 2025 Plan and any shares underlying options outstanding under the 2021 Plan that expire or otherwise terminate prior to exercise or settlement, as applicable, after the effective date of the 2025 Plan), as well as any future increases in the number of shares of common stock reserved for issuance thereunder, as more fully described in the section titled “Executive Compensation — Equity Incentive Plans — 2025 Equity Incentive Plan”;

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• shares of our common stock reserved for future issuance under the ESPP, which will become effective on the date of the underwriting agreement related to this offering, as well as any automatic increases in the number of shares of common stock reserved for future issuance under the ESPP;

• shares of our common stock issuable upon conversion of an aggregate of $1.2 million of the CEO SAFEs issued by us to our Chief Executive Officer and an affiliate of our Chief Executive Officer in March 2023, which will occur upon the closing of this offering, assuming an initial public offering price of $ per share, which is the midpoint of the price range set forth on the cover page of this prospectus; and

• Representative’s Warrants to purchase up to shares of our common stock at an exercise price equal to 125% of the offering price.

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DILUTION

If you invest in our common stock in this offering, your ownership interest will be immediately diluted to the extent of the difference between 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 after this offering.

As of September 30, 2025, we had a historical net tangible book deficit of $22,754, or $(8.15) per share of common stock. Our historical net tangible book deficit per share represents total tangible assets less total liabilities and the carrying values of our preferred stock, which is not included within stockholders’ deficit, divided by the number of shares of our common stock outstanding as of September 30, 2025.

Our pro forma net tangible book deficit as of September 30, 2025 was $ million, or $ per share of common stock. Pro forma net tangible book value represents the amount of our total tangible assets less our total liabilities, after giving effect of (i) the conversion of all of our outstanding shares of preferred stock as of September 30, 2025, including 7,250,000 shares of our Series A preferred stock and 1,092,707 shares of our Series A-1 preferred stock, into an aggregate of 8,342,707 shares of common stock upon the closing of this offering (ii) the issuance of shares of our common stock upon the conversion of $1.2 million of the CEO SAFEs issued by us to our Chief Executive Officer and an affiliate of our Chief Executive Officer in March 2023, which will occur upon the closing of this offering, assuming an initial public offering price of $ per share, which is the midpoint of the price range set forth on the cover page of this prospectus, (iii) the issuance of shares of common stock upon the conversion of our approximately $ million of certain related party convertible debt instruments, with mandatory conversion features, which will occur upon the closing of this offering assuming an initial public offering price of per share which is the midpoint of the price range set forth on the cover page of this prospectus, and (iv) additional borrowings of $ million under the InveniAI Line of Credit subsequent to September 30, 2025, as if such conversions had occurred on September 30, 2025. Pro forma net tangible book value per share represents pro forma net tangible book value divided by the total number of shares outstanding as of September 30, 2025, after giving effect to the pro forma adjustment described above

After giving further effect to (i) the pro forma adjustments described above, (ii) the repayment of approximately $1.8 million of aggregate indebtedness under the InveniAI Line of Credit and certain related party promissory notes using a portion of the net proceeds of this offering, and (iii) our sale and issuance of shares of our common stock in this offering at an assumed initial public offering price of $ per share, which is the midpoint of the price range set forth on the cover page of this prospectus, our pro forma as adjusted net tangible book value as of September 30, 2025 would have been $ million, or $ per share. This amount represents an immediate increase in pro forma net tangible book value of $ per share to our existing stockholders and immediate dilution of $ per share to new investors in this offering. We determine dilution by subtracting the pro forma as adjusted net tangible book value per share after this offering from the amount of cash that a new investor paid for a share of common stock in this offering.

The following table illustrates this dilution:

Assumed initial public offering price per share			$
Historical net tangible book deficit per share as of September 30, 2025	$	( )
Pro forma increase in historical net tangible book value per share attributable to the pro forma transactions described above
Pro forma net tangible book value per share as of September 30, 2025
Increase in pro forma net tangible book value per share attributable to new investors participating in this offering
Pro forma as adjusted net tangible book value per share after this offering
Dilution per share to new investors participating in this offering			$

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The dilution information discussed above is illustrative only and will change based on the actual initial public offering price and other terms of this offering determined at pricing. Each $1.00 increase (decrease) in the assumed initial public offering price of $ per share, which is the midpoint of the price range set forth on the cover page of this prospectus, would increase (decrease) the pro forma as adjusted net tangible book value per share after this offering by approximately $ , and dilution in pro forma net tangible book value per share to new investors by approximately $ , 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. An increase of 1.0 million shares in the number of shares we are offering would increase the pro forma as adjusted net tangible book value per share after this offering by $ and decrease the dilution per share to new investors participating in this offering by $ , assuming no change in the assumed initial public offering price per share and after deducting the estimated underwriting discounts and commissions. A decrease of 1.0 million shares in the number of shares we are offering would decrease the pro forma as adjusted net tangible book value per share after this offering by $ and increase the dilution per share to new investors participating in this offering by $ , assuming no change in the assumed initial public offering price per share and after deducting the estimated underwriting discounts and commissions.

If the underwriters exercise their option to purchase additional shares of our common stock in full, the pro forma as adjusted net tangible book value after this offering would be $ per share, the increase in pro forma net tangible book value per share would be $ and the dilution per share to new investors would be $ per share, in each case assuming an initial public offering price of $ per share, which is the midpoint of the price range set forth on the cover page of this prospectus.

The following table summarizes, as of September 30, 2025, on the pro forma as adjusted basis described above, the differences between the number of shares purchased from us, the total consideration paid to us in cash and the average price per share that existing stockholders and new investors paid for such shares. The calculation below is based on an assumed initial public offering price of $ per share, which is the midpoint of the price range set forth on the cover page of this prospectus, before deducting the estimated underwriting discounts and commissions and estimated offering expenses payable by us.

Shares Purchased

Total Consideration

Weighted
Average Price
Per Share

Number

Percentage

Amount

Percentage

Existing stockholders

New investors

Total

The foregoing tables and calculations are based on the number of shares of our common stock outstanding as of September 30, 2025, after giving effect to the conversion of all outstanding shares of our preferred stock into an aggregate of 8,342,707 shares of common stock, and excludes:

• 4,345,250 shares of our common stock issuable upon exercise of stock options under our 2021 Plan, outstanding as of September 30, 2025 with a weighted average exercise price of $1.39 per share,

• 53,000 shares of our common stock reserved for future issuance under the 2021 Plan as of September 30, 2025;

• 101,061 shares of our common stock issuable upon exercise of warrants issued after September 30, 2025 with an exercise price of $4.81 per share;

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2024 Plan and any shares underlying options outstanding under the 2021 Plan that expire or otherwise terminate prior to exercise or settlement, as applicable, after the effective date of the 2024 Plan), as well as any future increases in the number of shares of common stock reserved for issuance thereunder, as more fully described in the section titled “Executive Compensation — Equity Incentive Plans — 2024 Equity Incentive Plan”,

• shares of our common stock issuable upon conversion of an aggregate of $ million of convertible debt instruments, which will occur upon the closing of this offering, assuming an initial public offering price of $ per share, which is the midpoint of the price range set forth on the cover page of this prospectus; and

• shares of our common stock issuable upon the exercise of the Representative’s Warrants to be issued in connection with this offering at an exercise price equal to 125% of the offering price.

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

You should read the following discussion and analysis of our financial condition and results of operations together with our audited financial statements and the related notes appearing elsewhere in this prospectus. In addition to historical information, this discussion and analysis contains forward-looking statements that involve risks, uncertainties, and assumptions. Our actual results may differ materially from those discussed below. Additionally, there may be other risks and uncertainties that we are unable to identify at this time or that we do not currently expect to have a material impact on its business. Factors that could cause or contribute to such differences include, but are not limited to, those identified below, and those discussed in the sections titled “Special Note Regarding Forward-Looking Statements” and “Risk Factors” included elsewhere in this prospectus.

Overview

We are a biotechnology company seeking to develop oral, small-molecule therapies for IMIDs. I

Invea Therapeutics, Inc S-1