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Item 1A. Risk Factors

2026-03-10 compared with 2025-03-20 · 304 added, 261 removed, 789 unchanged (42% of the section changed)

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These risks are discussed more fully below and include, but are not limited to, risks related to:

Our Financial Position and Need for Additional Capital

• our need for additional capital to continue the development and commercialization of our drug candidates;

• the impact of raising additional capital to our stockholders and the rights of our drug candidates;

• our ability to achieve or maintain profitability;

• our financial condition and ability to continue as a going concern:

• our ability to generate revenue in absence of any products approved for sale;

The Development and Regulatory Approval of Our Drug Candidates

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• our ability to obtain approval to commercialize products outside the United States;

Risks Relating to Our Dependence on Third Parties

• our ability to establish and maintain collaborative relationships to further the development of our drug candidates;

• the professional conduct of third parties we rely on to conduct, supervise and monitor certain of our clinical trials;

• our dependence on limited sources of supply for the components used in cadisegliatin (TTP399) and our other drug candidates;

• our reliance on third-party manufacturers to produce our drug candidates;

Our Financial Position and Need for Additional Capital

• our need for additional capital to continue the development and commercialization of our drug candidates;

• the impact of raising additional capital to our stockholders and the rights of our drug candidates;

• our ability to achieve or maintain profitability;

• our financial condition and ability to continue as a going concern:

• our ability to generate revenue in absence of any products approved for sale;

Risks Relating to Our Intellectual Property

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• our ability to obtain patent term extensions for our drug candidates;

Risks Relating to Our Dependence on Third Parties

• our ability to establish and maintain collaborative relationships to further the development of our drug candidates;

• the professional conduct of third parties we rely on to conduct, supervise and monitor certain of our clinical trials;

• our dependence on limited sources of supply for the components used in cadisegliatin (TTP399) and our other drug candidates;

• our reliance on third-party manufacturers to produce our drug candidates;

Risks Relating to Employee Matters and Managing Growth

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• our ability to make distributions from vTv LLC to satisfy our obligations.

Risks Relating to Our Financial Position and Need for Additional Capital

We have incurred significant losses since inception and anticipate that we will incur continued losses for the foreseeable future.

We may never achieve or maintain profitability.

We are a clinical stage pharmaceutical company with limited operating history.

We have never been profitable and do not expect to be profitable in the foreseeable future.

We have incurred net losses in each year since beginning to develop our drug candidates, including net losses of approximately $18.5 million, $20.3 million and $19.2 million for the years ended December 31, 2024, 2023 and 2022, respectively.

As of December 31, 2024, we had a total accumulated deficit of approximately $299.7 million.

We have not commercialized any products and have devoted most of our financial resources to research and development, including our preclinical development activities and clinical trials.

We expect to incur significant additional operating losses for the next several years, at least, as we conduct our research and development activities, advance drug candidates through clinical development, complete clinical trials, seek regulatory approval and, if we receive FDA approval, commercialize our products.

Furthermore, the costs of advancing drugs into each succeeding clinical phase tend to increase substantially over time.

The total costs to advance any of our drug candidates to marketing approval in even a single jurisdiction would be substantial.

Because of the numerous risks and uncertainties associated with pharmaceutical product development, we are unable to accurately predict the timing or amount of increased expenses or when, or if, we will be able to begin generating revenue from the commercialization of products or achieve or maintain profitability.

We expect to continue to incur significant additional expenses as we continue the development of cadisegliatin .

Furthermore, our ability to successfully develop, commercialize and license our products and generate product revenue is subject to substantial additional risks and uncertainties, as described under “—Risks Relating to the Discovery, Development and Regulatory Approval of Our Drug Candidates” and “—Risks Relating to the Commercialization of Our Drug Candidates.” As a result, we expect to continue to incur net losses and negative cash flows for the foreseeable future.

These net losses and negative cash flows have had, and will continue to have, an adverse effect on our stockholders’ equity and working capital.

The amount of our future net losses will depend, in part, on the rate of future growth of our expenses and our ability to generate revenues.

In addition, we may not be able to enter into any collaborations that will generate significant cash.

If we are unable to develop and commercialize one or more of our drug candidates either alone or with collaborators, or if revenues from any drug candidate that receives regulatory approval are insufficient, we will not achieve profitability.

Even if we do achieve profitability, we may not be able to sustain or increase profitability.

If we are unable to achieve and then maintain profitability, the value of our equity securities will be materially and adversely affected.

Currently, we have no products approved for commercial sale, and to date we have not generated any revenue from product sales.

As a result, our ability to generate revenue from products, curtail our losses and reach profitability is unproven, and we may never generate substantial product revenue.

We have no products approved for commercialization and have never generated any revenue from the commercialization of any product.

Our ability to generate revenue and achieve profitability depends on our ability, alone or with strategic collaboration partners, to successfully complete the development of, and obtain the regulatory and marketing approvals necessary to commercialize one or more of our product candidates.

We do not anticipate generating revenue from product sales for several years.

Our ability to generate future revenue from product sales depends heavily on our success in many areas, including but not limited to:

• completing research and nonclinical and clinical development of our product candidates;

• obtaining regulatory and marketing approvals for product candidates for which we complete clinical studies;

• establishing collaborations for the development of certain of our drug candidates;

• establishing and maintaining supply and manufacturing relationships with third parties that can provide adequate, in both amount and quality, products and services to support clinical development and the market demand for our product candidates, if approved;

• launching and commercializing product candidates for which we obtain regulatory and marketing approval, either directly or with a collaborator or distributor;

• obtaining market acceptance of our product candidates as viable treatment options;

• obtaining favorable formulary placement with government and third-party payors that allows for favorable reimbursement;

• addressing any competing technological and market developments;

• negotiating favorable terms in any collaboration, licensing, or other arrangements into which we may enter;

• maintaining, protecting and expanding our portfolio of intellectual property rights;

• attracting, hiring and retaining qualified personnel.

Even if one or more of the product candidates that we develop is approved for commercial sale, we anticipate incurring significant costs associated with commercializing any approved product candidate.

Our expenses could increase beyond expectations if we are required by the FDA or other regulatory authorities to perform clinical and other studies in addition to those that we currently anticipate.

Even if we are able to generate revenues from the sale of any approved products, we may not become profitable and may need to obtain additional funding to continue operations.

We will need additional capital to complete the development and commercialization of cadisegliatin (TTP399) and our other drug candidates.

If we are unable to raise sufficient capital for these purposes, we would be forced to delay, reduce or eliminate our product development programs.

Developing pharmaceutical products, including conducting preclinical studies and clinical trials, is expensive.

We expect to continue to incur significant research and development expenses in connection with our ongoing activities, particularly as we undertake additional clinical trials of cadisegliatin and our other drug candidates and continue to work on our other research programs.

Our current capital will not be sufficient for us to complete the development of cadisegliatin or our other drug candidat es.

A s such, we will need to raise additional capital to fund the planned trials for our drug candidates and prior to the commercialization of any of our drug candidates.

We are seeking possible additional partnering opportunities for our GKA, GLP-1r and other drug candidates which we believe may provide additional cash for use in our operations and the continuation of the clinical trials for our drug candidates.

We also continue to evaluate other financing strategies to fund our ongoing trials.

Such financing strategies include direct equity investments and future public offerings of our common stock.

The timing and availability of such financing are not yet known.

If the FDA or other regulators require that we perform additional studies beyond those we currently expect, or if there are any delays in completing our clinical trials or the development of any of our drug candidates, our expenses could increase beyond what we currently anticipate and the timing of any potential product approval may be delayed.

We have no commitments or arrangements for any additional financing to fund our research and development programs other than the funds we may raise through the sale of our Class A common stock under our sales agreement (the “TD Cowen Sales Agreement”) with Cowen & Company, LLC (“TD Cowen”) (the “TD Cowen ATM Offering”).

As of March 20, 2025, there remains $47.5 million of availability under the TD Cowen ATM Offering, although the amount of our Class A common stock that we may offer and sell under the TD Cowen ATM Offering during any 12 calendar month period is currently limited to one-third of the aggregate market value of our voting and non-voting common equity held by non-affiliates pursuant to General Instruction I.B.6 of Form S-3.

In addition, our ability to use this source of capital is dependent on a number of factors, including the prevailing market price of and the volume of trading in our Class A common stock.

We also will need to raise substantial additional capital in the future to conduct further clinical trials of cadisegliatin and to continue developing our other drug candidates.

Although we continue to seek financing, partnering and licensing transactions for the further development of cadisegliatin , these efforts may not be successful.

Because successful development of our drug candidates is uncertain, we are unable to estimate the actual funds required to complete research and development and commercialize and license our products under development.

Until such time that we can generate substantial revenue from product sales, we expect to finance our operating activities through a combination of equity offerings, debt financings, marketing and distribution arrangements and other collaborations, strategic alliances and licensing arrangements.

We may seek to access the public or private capital markets whenever conditions are favorable, even if we do not have an immediate need for additional capital at that time.

If worldwide economic conditions and the international equity and credit markets deteriorate and return to depressed states, it will be more difficult for us to obtain additional equity or credit financing, when needed.

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

• the progress, costs, results and timing of our planned registrational trial(s) for cadisegliatin as a potential adjunctive therapy to insulin for the treatment of type 1 diabetes;

• the outcome, costs and timing of seeking and obtaining FDA and any other regulatory approvals;

• the number and characteristics of drug candidates that we pursue, including our drug candidates in preclinical development;

• the ability of our drug candidates to progress through clinical development successfully;

• our need to expand our research and development activities;

• the costs associated with securing, establishing and maintaining commercialization capabilities;

• the costs of acquiring, licensing or investing in businesses, products, drug candidates and technologies;

• our ability to maintain, expand and defend the scope of our intellectual property portfolio, including the amount and timing of any payments we may be required to make, or that we may receive, in connection with the licensing, filing, prosecution, defense and enforcement of any patents or other intellectual property rights;

• our need and ability to hire additional management and scientific and medical personnel;

• the effect of competing technological and market developments;

• our need to implement additional internal systems and infrastructure, including financial and reporting systems;

• the economic and other terms, timing and success of our existing licensing arrangements and any collaboration, licensing or other arrangements into which we may enter in the future;

• the amount of any payments we are required to make to M&F TTP Holdings Two LLC in the future under the Tax Receivable Agreement.

There is substantial doubt as to our ability to continue as a going concern.

We will need additional financing to execute our business plan, to fund our operations, and to continue as a going concern.

Our disclosure regarding the substantial doubt as to our ability to continue as a going concern may hinder our ability to obtain further financing.

To date, we have not generated any product revenue and has not achieved profitable operations, and our current capital will not be sufficient for us to complete the development of our drug candidates.

As such, we will need to raise additional capital to fund the planned trials for our drug candidates and prior to the commercialization of any of our drug candidates.

As a result of these factors, we have determined that there is substantial doubt as to our ability to continue as a going concern.

Our ability to continue as a going concern will depend on our ability to obtain additional funding, and no assurances can be given that additional funding will be available to us on commercially reasonable terms, or at all.

If we are unable to raise sufficient capital when needed, it may materially and adversely affect our business, financial condition, results of operations, and prospects, and we will need to modify our operational plans to continue as a going concern.

Moreover, the reaction of investors to the inclusion of a going concern statement in our financial statements and our potential inability to continue as a going concern could adversely affect the price of our common stock and our ability to raise new capital or enter into collaborative or other transactions.

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

Until such time, if ever, as we can generate substantial revenue, we may finance our cash needs through a combination of equity offerings, debt financings, marketing and distribution arrangements and other collaborations, strategic alliances and licensing arrangements.

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, the interest of our stockholders will be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect the rights of our common stockholders.

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.

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 or drug candidates or grant licenses on terms that may not be favorable to us.

If we are unable to raise additional funds through equity or debt financings when needed, we may be required to delay, limit, reduce or terminate our product development or future commercialization efforts or grant rights to develop and market drug candidates that we would otherwise prefer to develop and market ourselves.

We have a limited operating history, and we expect a number of factors to cause our operating results to fluctuate on a quarterly and annual basis, which may make it difficult to predict our future performance.

We are a clinical stage pharmaceutical company with a limited operating history.

Our operations to date have been primarily limited to developing our technology and undertaking preclinical studies and clinical trials of cadisegliatin and our other drug candidates.

We have not yet obtained regulatory approvals for any of our drug candidates.

Consequently, any statements about our future success or viability are not based on any substantial operating history or commercialized products.

Our financial condition and operating results have varied significantly in the past and will continue to fluctuate from quarter-to-quarter or year-to-year due to a variety of factors, many of which are beyond our control.

As a result, we may

never successfully develop and commercialize a product, which could lead to a material adverse effect on the value of any investment in our securities.

Risks Relating to the Development, Regulatory Approval, and Commercialization of Our Drug Candidates

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We cannot be certain that any of these submissions will be accepted for filing and reviewed by the FDA, or that the marketing approval application submissions to any other regulatory authorities will be accepted for filing and review by those authorities.

We cannot be certain that we will be able to respond to any regulatory

requests during the review period in a timely manner, or at all, without delaying potential regulatory action.

We cannot be certain that we will be able to respond to any regulatory requests during the review period in a timely manner, or at all, without delaying potential regulatory action.

We also cannot be certain that any of our drug candidates will receive favorable recommendations from any FDA advisory committee or foreign regulatory bodies or be approved for marketing by the FDA or foreign regulatory authorities.

In addition, delays in approvals or rejections of marketing applications may be based upon many factors, including regulatory requests for additional analyses, reports, data and studies, regulatory questions regarding data and results, changes in regulatory policy during the period of product development and the emergence of new information regarding our drug candidates.

In addition, delays in

approvals or rejections of marketing applications may be based upon many factors, including regulatory requests for additional analyses, reports, data and studies, regulatory questions regarding data and results, changes in regulatory policy during the period of product development and the emergence of new information regarding our drug candidates.

Data obtained from preclinical studies and clinical trials are subject to different interpretations, which could delay, limit or prevent regulatory review or approval of any of our drug candidates.

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Review times can be affected by a variety of factors, including budget and funding levels and statutory, regulatory and policy as well as personnel changes at the FDA.

In addition, the current U.S.

Presidential administration has issued certain policies and Executive Orders directed towards reducing the employee headcount and costs associated with U.S.

administrative agencies, including the FDA, and it remains unclear the degree to which these efforts may limit or otherwise adversely affect the FDA's ability to conduct routine activities.

Moreover, in light of widely publicized events concerning the safety risk of certain drug products, regulatory authorities, members of the U.S.

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We do not know whether current or future clinical trials of our drug candidates will begin on time or at all or will be completed on schedule or at all.

The commencement, enrollment and completion of our clinical trials can be delayed for a variety of reasons, including:

• inability to reach agreements on acceptable terms with prospective contract research organizations (CRO) and trial sites, the terms of which can be subject to extensive negotiation and may vary significantly among different CROs and trial sites;

The commencement, enrollment and completion of our clinical trials, including our CATT1 Phase 3 clinical trial, can be delayed for a variety of reasons, including:

• difficulty recruiting and enrolling subjects to participate in clinical trials for a variety of reasons, including willingness of subjects to undergo required study procedures, meeting the enrollment criteria for our study and competition from other clinical trial programs for the same indication as our drug candidates;

• inability to recruit and retain subjects in clinical trials due to the treatment protocol, personal issues, side effects from the therapy or lack of efficacy;

• regulatory objections to commencing or continuing a clinical trial, including the imposition of a clinical hold;

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• inability to obtain institutional review board (“IRB”), approval to conduct a clinical trial;

• inability to recruit and retain subjects in clinical trials due to the treatment protocol, personal issues, side effects from the therapy or lack of efficacy;

• difficulty in importing and exporting clinical trial materials and study samples;

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, the proximity of patients to clinical sites, the eligibility criteria for the trial, the design of the clinical trial, competing clinical trials and clinicians’ and patients’ perceptions as to the potential advantages of the drug being studied in relation to other available therapies, including any new drugs that may be approved for the indications we are investigating.

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We expect that our existing and future drug candidates will face competition, and most of our competitors have significantly greater resources than we do.

The biopharmaceutical industry is characterized by intense competition and rapid innovation.

Our potential competitors include large pharmaceutical and biotechnology companies, specialty pharmaceutical companies, generic or biosimilar drug companies, universities and other research institutions.

Our drug candidates, if successfully developed and approved, will compete in crowded and competitive markets.

In order to compete with approved products, our drug candidates will need to demonstrate compelling advantages.

We believe the key competitive factors that will affect the development and commercial success of our drug candidates are efficacy, safety and tolerability profile, mechanism of action, control and predictability, convenience of dosing and price and reimbursement.

Oral non-insulin agents that are currently being developed to treat type 1 diabetes that may compete with cadisegliatin include the menin inhibitor BMF219 and TIXiMED TIX-100, a drug candidate that targets thioredoxin-interacting protein (TXNIP), a detrimental protein that is elevated in diabetes and leads to beta cell death and dysfunction.

SGLT-2 inhibitors such as dapagliflozin (Farxiga) and ipragliflozin (Suglat) continue to be approved in Japan for T1D but have not been approved for use in the US due to safety risks including those pertaining to diabetic ketoacidosis.

Injectable agents include the somatostatin type 2 receptor blocker ZT-01 by Zucara to treat nocturnal hypoglycemia, the dual GLP-1/GIP agonist CT-868 for overweight or obese type 1 diabetics, Diasome's liver-targeting HDV Lispro insulin, Adocia's ultrarapid acting biochaperone insulin as well as REMD Biotherapeiutics Volagidemab Glucagon receptor Antagonist.

Teplizumab (Tzield) is a FDA approved immune agent to delay the onset of stage 3 T1D disease progression in adult and pediatric patients.

Lantidra is a FDA pproved allogeneic islet cell transplant therapy indicated for patients with T1D who cannot achieve satisfactory glycemic control because of frequent hypoglycemia.

The treatment requires adjunct immunosuppressive therapy to mitigate organ rejection.

Vertex continues to develop stem cell-based therapies including VX-880 (phase 3) and VX-264 (encapsulated beta cells, phase 1/2) which are planned to be used with or without concurrent immunosuppressive therapy, respectively.

There are several Beta cell replacement programs currently in development by companies including, but not limited to, Sernova, Seraxis, PolTreg, and Sana Biotechnology, which are in early phases 1/2 of clinical development.

Medical device technology such as continuous glucose monitors, Smart Connected Insulin Pens systems and automated insulin delivery systems continue to evolve to address glycemic control and the reduction of hypoglycemia.

The biopharmaceutical industry is characterized by intense competition and rapid technological innovation.

Our potential competitors include large pharmaceutical and biotechnology companies, specialty pharmaceutical companies, generic and biosimilar drug manufacturers, universities, and other research institutions.

Our drug candidates, if successfully developed and approved, would compete in highly competitive markets with established therapies.

To compete effectively, our drug candidates will need to demonstrate compelling clinical and commercial advantages over existing and emerging alternatives.

We believe the key competitive factors that will affect the development and commercial success of our drug candidates include efficacy, safety and tolerability profile, mechanism of action, predictability and consistency of effect, convenience of dosing, and price and reimbursement.

Oral Non-Insulin Agents

Several oral non-insulin agents are in development or approved that may compete with cadisegliatin for the treatment of type 1 diabetes ("T1D").

These include TIXiMED's TIX-100, a drug candidate targeting thioredoxin-interacting protein (TXNIP), a protein elevated in diabetes that has been associated with beta cell death and dysfunction.

SGLT-2 inhibitors, including dapagliflozin (Farxiga) and ipragliflozin (Suglat), have received approval in Japan for use in T1D but have not been approved in the United States due to safety concerns, including the risk of diabetic ketoacidosis.

In late 2024, the U.S.

Food and Drug Administration ("FDA") declined to approve Lexicon Pharmaceuticals' sotagliflozin (Zynquista), a dual SGLT-1/SGLT-2 inhibitor, for use in T1D;

however, Lexicon continues to pursue regulatory approval for this indication.

Additionally, Eli Lilly's JAK inhibitor baricitinib is in clinical development as a potential therapy to delay the onset of clinical stage 3 T1D in high-risk individuals and to preserve beta cell function in patients with newly diagnosed T1D.

Injectable Agents

Several injectable agents are currently in development for the treatment of T1D.

These include ZT-01, a somatostatin type 2 receptor blocker being developed by Zucara Therapeutics for the treatment of nocturnal hypoglycemia;

dual GLP-1/GIP receptor agonists in development by Carmot Therapeutics and Eli Lilly aimed at improving glycemic control in overweight or obese individuals with T1D;

Diasome Pharmaceuticals' liver-targeted HDV Lispro insulin;

Adocia's ultrarapid-acting BioChaperone insulin;

and volagidemab, a glucagon receptor antagonist being developed by REMD Biotherapeutics.

Immune-Modulating and Disease-Modifying Therapies

Teplizumab (Tzield), developed by Sanofi, is an FDA-approved immune therapy indicated to delay the onset of stage 3 T1D in adult and pediatric patients eight years of age and older.

The product has also received approval in the European Union under the brand name Teizeild.

In 2025, an application for teplizumab was accepted by the FDA for expedited review for use in patients recently diagnosed with stage 3 T1D;

if approved, it would represent the first disease-modifying therapy indicated for this population.

Cell-Based and Transplant Therapies

Lantidra is an FDA-approved allogeneic islet cell transplant therapy indicated for patients with T1D who are unable to achieve adequate glycemic control due to recurrent severe hypoglycemia.

Lantidra requires concurrent immunosuppressive therapy to prevent organ rejection.

Vertex Pharmaceuticals continues to advance stem cell-derived therapies, including VX-880, which is also intended for use with immunosuppressive therapy.

A number of additional beta cell replacement programs are in development by companies including, but not limited to, Sernova, Seraxis, PolTreg, and Sana Biotechnology, utilizing diverse approaches with the goal of eliminating the need for chronic immunosuppression.

Medical Devices

Medical device technologies, including continuous glucose monitors, smart connected insulin pen systems, and automated insulin delivery systems, continue to advance and may compete with pharmacological approaches by addressing glycemic control and reducing the frequency and severity of hypoglycemic events.

Many of our potential competitors have substantially greater:

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In addition to continuing pressure on prices and cost containment measures, legislative developments at the European Union or member state level may result in significant additional requirements or obstacles that may increase our operating costs.

We are unable to predict the future course of federal or state healthcare legislation in the United States directed at broadening the availability of healthcare and containing or lowering the cost of healthcare, particularly in light of the recent U.S.

Presidential and Congressional elections.

The current Presidential administration is pursuing policies to reduce regulations and expenditures across government including at HHS, the FDA, the Centers for Medicare & Medicaid Services, or CMS, and related agencies.

These actions, presently directed by Executive Orders or memoranda from the Office of Management and Budget, may propose policy changes that create additional uncertainty for our business.

These actions and proposals include, for example, (1) reducing agency workforces and programs;

(2) rescinding a Biden administration Executive Order tasking the Center for Medicare and Medicaid Innovation to consider new payment and healthcare models to limit drug spending;

(3) eliminating the Biden Administration's Executive Order that directed HHS to establish an artificial intelligence task force and develop a strategic plan regarding artificial intelligence;

(4) directing HHS and other agencies to lower prescription drug costs through a variety of initiatives, including by improving upon the Medicare Drug Price Negotiation Program and establishing Most-Favored-Nation pricing for pharmaceutical products;

(5) imposing tariffs on imported pharmaceutical products;

and (b) directing certain federal agencies to enforce existing law regarding hospital and health plan price transparency and standardize prices across hospitals and health plans.

Additionally, in its June 2024 decision in Loper Bright Enterprises v.

Raimondo, or Loper Bright, the U.S.

Supreme Court overturned the longstanding Chevron doctrine, under which courts were required to give deference to regulatory agencies' reasonable interpretations of ambiguous federal statutes.

The Loper Bright decision could result in additional legal challenges to current regulations and guidance issued by federal agencies applicable to our operations, including those issued by FDA.

Congress may introduce and ultimately pass healthcare related legislation that could, among other things, impact the drug approval process,

Moreover, legislative and regulatory proposals have also been made to expand post-approval requirements and restrict sales and promotional activities for pharmaceutical drugs.

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The FDCA vests authority with the FDA to conduct inspections of sponsors conducting pharmaceutical development, such as vTv, to protect the rights, safety and welfare of clinical trial subjects, ensure the accuracy and reliability of clinical trial data, and verify compliance with FDA regulations.

The FDCA sets forth the standards for approval of new and generic drugs, as well as setting forth the prohibition on marketing investigational products that have not been approved by the FDA as safe and

The government (FDA and SEC) use the FDCA to ensure that companies do not mislead the medical, patient or investor communities about investigational products prior to their approval.

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A person or entity does not need to have actual knowledge of the statute or specific intent to violate it to have committed a violation.

In addition, the Affordable Care Act provided that 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 False Claims Act;

In addition, the Affordable Care Act provided that 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 False Claims Act;

• federal civil and criminal false claims laws, including the federal False Claims Act, which impose criminal and civil penalties, including civil whistleblower actions, against individuals or entities for, among other things, knowingly presenting, or causing to be presented, to the federal government, including the Medicare and Medicaid programs, claims for payment that are false or fraudulent or making a false statement to avoid, decrease or conceal an obligation to pay money to the federal government;

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• the federal Physician Payments Sunshine Act and its implementing regulations, which imposed annual reporting requirements for certain manufacturers of drugs, devices, biological products and medical supplies for payments and “transfers of value” provided to physicians and teaching hospitals, as well as ownership and investment interests held by physicians and their immediate family members;

• analogous state and foreign laws, such as state anti-kickback and false claims laws, which may apply to sales or marketing arrangements and claims involving healthcare items or services reimbursed by non-governmental

third-party payors, including private insurers;

state laws that require pharmaceutical companies to comply with the pharmaceutical industry’s voluntary compliance guidelines and the relevant compliance guidance promulgated by the federal government or otherwise restrict payments that may be made to healthcare providers;

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It is possible that governmental authorities will conclude that our business activities, including our relationships with physician consultants, some of whom may prescribe our product candidates, if approved, in the future, may not comply with current or future statutes, regulations or case law involving applicable fraud and abuse or other healthcare laws.

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 civil, criminal and administrative penalties, including, without limitation, damages, fines, imprisonment, exclusion from participation in government healthcare programs, such as Medicare and Medicaid, and the curtailment or restructuring of our operations, which could significantly harm our business.

without limitation, damages, fines, imprisonment, exclusion from participation in government healthcare programs, such as Medicare and Medicaid, and the curtailment or restructuring of our operations, which could significantly harm our business.

If we try to obtain approval to commercialize any products outside the United States, many of the same risks that apply to obtaining approvals in the United States will likely apply to such a process, and even if we obtain approval to commercialize any such products outside of the United States, a variety of risks associated with international operations could materially adversely affect our business.

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• difficulty in importing and exporting clinical trial materials and study samples.

Risks Relating to Our Dependence on Third Parties

We may not succeed in establishing and maintaining collaborative relationships, which may significantly limit our ability to develop and commercialize our drug candidates successfully, if at all.

We intend to seek collaborative relationships for the development and/or commercialization of our drug candidates, including cadisegliatin .

Failure to obtain a collaborative relationship for these candidates, particularly in the European Union and for other markets requiring extensive sales efforts, may significantly impair the potential for our drug candidates.

We also will need to enter into collaborative relationships to provide funding to support our other research and development programs.

The process of establishing and maintaining collaborative relationships is difficult, time-consuming and involves significant uncertainty, including:

• a collaboration partner may shift its priorities and resources away from our drug candidates due to a change in business strategies, or a merger, acquisition, sale or downsizing;

• a collaboration partner may seek to renegotiate or terminate their relationships with us due to unsatisfactory clinical results, manufacturing issues, a change in business strategy, a change of control or other reasons;

• a collaboration partner may cease development in therapeutic areas which are the subject of our strategic collaboration;

• a collaboration partner may not devote sufficient capital or resources towards our drug candidates;

• a collaboration partner may change the success criteria for a drug candidate thereby delaying or ceasing development of such candidate;

• a significant delay in initiation of certain development activities by a collaboration partner will also delay payment of milestones tied to such activities, thereby impacting our ability to fund our own activities;

• a collaboration partner could develop a product that competes, either directly or indirectly, with our drug candidate;

• a collaboration partner with commercialization obligations may not commit sufficient financial or human resources to the marketing, distribution or sale of a product;

• a collaboration partner with manufacturing responsibilities may encounter regulatory, resource or quality issues and be unable to meet demand requirements;

• a partner may exercise a contractual right to terminate a strategic alliance;

• a dispute may arise between us and a partner concerning the research, development or commercialization of a drug candidate resulting in a delay in milestones, royalty payments or termination of an alliance and possibly resulting in costly litigation or arbitration which may divert management attention and resources;

• a partner may use our products or technology in such a way as to invite litigation from a third party.

Any collaborative partners we enter into agreements with in the future may shift their priorities and resources away from our drug candidates or seek to renegotiate or terminate their relationships with us.

If any collaborator fails to fulfill its responsibilities in a timely manner, or at all, our research, clinical development, manufacturing or commercialization efforts related to that collaboration could be delayed or terminated, or it may be necessary for us to assume responsibility for expenses or activities that would otherwise have been the responsibility of our collaborator.

If we are unable to establish and maintain collaborative relationships on acceptable terms or to successfully transition terminated collaborative agreements, we may have to delay or discontinue further development of one or more of our drug candidates, undertake development and commercialization activities at our own expense or find alternative sources of capital.

We rely on third parties to conduct, supervise and monitor certain of our clinical trials, and if those third parties perform in an unsatisfactory manner, it may harm our business.

We rely on CROs and clinical trial sites to ensure the proper and timely conduct of certain of our clinical trials.

While we have agreements governing their activities, and continue to monitor their compliance with those agreements as well as federal standards and regulations, we have limited influence over their actual performance.

We will control only certain aspects of our CROs’ activities.

Nevertheless, we will be responsible for ensuring that our clinical trials are conducted in accordance with the applicable protocol, legal, regulatory and scientific standards and our reliance on the CROs does not relieve us of our regulatory responsibilities.

We and our CROs are required to comply with the FDA’s good clinical practices requirements (“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 clinical trial participants are protected.

The FDA enforces these GCPs through periodic inspections of trial sponsors, principal investigators and clinical trial sites.

If we or our CROs fail to comply with applicable GCPs, the clinical data generated in our clinical trials may be deemed unreliable and the FDA may require us to perform additional clinical trials before approving any marketing applications.

Upon inspection, the FDA may determine that our clinical trials did not comply with GCPs.

In addition, our clinical trials conducted by third parties will require a sufficiently large number of test subjects to evaluate the safety and effectiveness of a drug candidate.

if our CROs fail to comply with these regulations or fail to recruit a sufficient number of patients, our clinical trials may be delayed or we may be required to repeat such clinical trials, which would delay the regulatory approval process.

Our CROs are not our employees, and although we monitor their activities related to our trials, we are not able to control whether or not they devote sufficient time and resources to our clinical trials.

If our CROs do not successfully carry out their contractual duties or obligations, fail to meet expected deadlines, or if the quality or accuracy of the clinical data they obtain is compromised due to the failure to adhere to our clinical protocols or regulatory requirements, or for any 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 drug candidates.

As a result, our financial results and the commercial prospects for such drug candidates would be harmed, our costs could increase, and our ability to generate revenues could be delayed.

We also rely on other third parties to store and distribute drug products for our clinical trials.

Any performance failure on the part of our distributors could delay clinical development or marketing approval of our drug candidates or commercialization of our products, if approved, producing additional losses and depriving us of potential product revenue.

We do not have multiple sources of supply for the components used in cadisegliatin (TTP399) and our other drug candidates.

If we were to lose a supplier, it could have a material adverse effect on our ability to complete the development of cadisegliatin or our other drug candidates.

If we obtain regulatory approval for cadisegliatin or our other drug candidates, we would need to expand the supply of their components in order to commercialize them.

We do not have multiple sources of supply for the components used in our drug candidates.

We also do not have long-term supply agreements with any of our suppliers.

If for any reason we are unable to obtain drug substance or drug product from the manufacturers we select, we would have to seek to obtain these from other manufacturers.

We may not be able to establish additional sources of supply for our drug candidates, or may be unable to do so on acceptable terms.

Such suppliers are subject to regulatory requirements, covering manufacturing, testing, quality control and record keeping relating to our drug candidates and subject to ongoing inspections by the regulatory agencies.

Failure by any of our suppliers to comply with applicable regulations may result in long delays and interruptions.

The number of suppliers of the raw material components of our drug candidates is limited.

In the event it is necessary or desirable to acquire supplies from an alternative supplier, we might not be able to obtain them on commercially reasonable terms, if at all.

It could also require significant time and expense to redesign our manufacturing processes to work with another company.

As part of any marketing approval, a manufacturer and its processes are required to be qualified by the FDA prior to commercialization.

If supply from the approved supplier is interrupted, there could be a significant disruption in commercial supply.

An alternative vendor would need to be qualified through an NDA amendment or supplement which could result in further delay.

The FDA or other regulatory agencies outside of the United States may also require additional studies if a new supplier is relied upon for commercial production.

Switching vendors may involve substantial costs and is likely to result in a delay in our desired clinical and commercial timelines.

If we are unable to obtain the supplies we need at a reasonable price or on a timely basis, it could have a material adverse effect on our ability to complete the development of our drug candidates or, if we obtain regulatory approval for our drug candidates, to commercialize them.

We intend to rely on third-party manufacturers to produce our drug candidates.

If we experience problems with any of these suppliers, the manufacturing of our drug candidates or products could be delayed.

We do not have the capability to manufacture our drug candidates and do not intend to develop that capability.

In order to continue to develop our drug candidates, apply for regulatory approvals and ultimately commercialize products, we need to develop, contract for or otherwise arrange for the necessary manufacturing capabilities.

The facilities used by our CMOs to manufacture our drug candidates must be approved by the FDA pursuant to inspections that will be conducted after we submit our NDA to the FDA.

We do not control the manufacturing process of, and are completely dependent on, our contract manufacturing partners for compliance with the regulatory requirements, known as cGMPs, for manufacture of both active drug substances and finished drug products.

If our CMOs cannot successfully manufacture material that conforms to our specifications and the regulatory requirements of the FDA or others, they will not be able to secure and/or maintain regulatory approval for their manufacturing facilities.

In addition, although we monitor our suppliers and their compliance with our contractual terms and federal laws and regulations, we do not control the ability of our contract manufacturers to maintain adequate quality control, quality assurance and qualified personnel.

If the FDA or a comparable foreign regulatory authority does not approve these facilities for the manufacture of our drug 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 drug candidates, if approved.

In addition, there are a limited number of manufacturers that operate under the FDA’s cGMP regulations capable of manufacturing our drug candidates.

As a result, we may have difficulty finding manufacturers for our drug candidates with adequate capacity for our needs.

If we are unable to arrange for third-party manufacturing of our drug candidates on a timely basis, or to do so on commercially reasonable terms, we may not be able to complete development of our drug candidates or market them.

Reliance on third-party manufacturers entails risks to which we might not be subject if we manufactured drug candidates ourselves, including:

• the limited number of manufacturers that could produce our drug candidates for us;

• the inability to meet our product specifications and quality requirements consistently;

• inability to access production facilities on a timely basis;

• inability or delay in increasing manufacturing capacity;

• manufacturing and product quality issues related to scale-up of manufacturing;

• costs and validation of new equipment and facilities required for commercial level activity;

• a failure to satisfy the FDA’s cGMP requirements and similar foreign standards on a consistent basis;

• the inability to negotiate manufacturing agreements with third parties under commercially reasonable terms;

• termination or nonrenewal of manufacturing agreements with third parties in a manner or at a time that is costly or damaging to us;

• the reliance on a single source of supply which, if unavailable, would delay our ability to complete our clinical trials or to sell any product for which we have received marketing approval;

• the lack of qualified backup suppliers for supplies that are currently purchased from a single source supplier;

• carrier disruptions or increased costs that are beyond our control;

• the failure to deliver products under specified storage conditions and in a timely manner.

Any of these risks could cause the delay of clinical trials, regulatory submissions, required approvals or commercialization of our products, cause us to incur higher costs and prevent us from commercializing our drug candidates successfully.

Manufacturing of our drug candidates and any approved products could be disrupted or halted if our third-party manufacturers do not comply with cGMP or foreign manufacturing standards, even if the compliance failure does not relate to our drug candidates or approved products.

Furthermore, if any of our drug candidates are approved and our third-party manufacturers fail to deliver the required commercial quantities of finished product on a timely basis and at commercially reasonable prices and we are unable to find one or more replacement manufacturers capable of production at a substantially equivalent cost, in substantially equivalent volumes and quality and on a timely basis, we would likely be unable to meet demand for our products and could lose potential revenue.

It may take several years to establish an alternative source of supply for our drug candidates and to have any such new source approved by the FDA or a foreign regulator.

Risks Relating to Our Financial Position and Need for Additional Capital

We have incurred significant losses since inception and anticipate that we will incur continued losses for the foreseeable future.

We may never achieve or maintain profitability.

We are a late-stage pharmaceutical company with limited operating history.

We have never been profitable and do not expect to be profitable in the foreseeable future.

We have incurred net losses in each year since beginning to develop our drug candidates, including net losses of approximately $27.0 million and $18.5 million and for the years ended December 31, 2025 and 2024, respectively.

As of December 31, 2025, we had a total accumulated deficit of approximately $326.7 million.