VTVT 10-K & 10-Q changes, risk factors and insider trading
vTv Therapeutics Inc. · Nasdaq · Pharmaceutical Preparations · CIK 1641489 · All filings on SEC.gov
At a glance
What changed in the latest 10-K
Risk Factors
New heading “Oral Non-Insulin Agents”
New heading “Injectable Agents”
New heading “Immune-Modulating and Disease-Modifying Therapies”
New heading “Cell-Based and Transplant Therapies”
New heading “Medical Devices”
New heading “Risks Relating to Our Dependence on Third Parties”
New heading “The use of new and evolving technologies, such as artificial intelligence, in our business may result in spending material resources and presents risks and challenges that can impact our business including by posing security and other risks to our confidential and/or proprietary information, including personal information, and as a result we may be exposed to reputational harm and liability.”
Removed heading “Risks Relating to Our Financial Position and Need for Additional Capital”
Removed heading “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.”
Largest changes
“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. …”see in full comparison
“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.”see in full comparison
“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. …”see in full comparison
“The use of new and evolving technologies, such as artificial intelligence, in our business may result in spending material resources and presents risks and challenges that can impact our business including by posing security and other risks to our confidential and/or proprietary information, including personal information, and as a result we may be exposed to reputational harm and liability.”see in full comparison
“Moreover, legislative and regulatory proposals have also been made to expand post-approval requirements and restrict sales and promotional activities for pharmaceutical drugs. We cannot be sure whether additional legislative changes will be enacted, or whether the FDA regulations, guidance or interpretations will be changed, or what the impact of such changes on the marketing approvals of our drug candidates, if any, may be. …”see in full comparison
“Risks Relating to Our Financial Position and Need for Additional Capital”see in full comparison
Full comparison: every changed paragraph (55)
•our need for additional capital to continue the development and commercialization of our drug candidates;
•our abilityneed for additional capital to establish and maintain collaborative relationships to furthercontinue the development and commercialization of our drug candidates;
•our ability to establish and maintain collaborative relationships to further the development of our drug candidates;
Risks Relating to Our Financial Position and Need for Additional Capital
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.
•establishing collaborations for the development of certain of our drug candidates;
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.
•the number and characteristics of drug candidates that we pursue, including our drug candidates in preclinical development;
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.
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.
In addition, the environment in which our regulatory submissions may be reviewed changes over time. For example, average review times at the FDA for NDAs have fluctuated over the last ten years, and we cannot predict the review time for any of our submissions with any regulatory authorities. 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. Government Accountability Office, medical professionals and the general public have raised concerns about potential drug safety issues. These events have resulted in the withdrawal of drug products, revisions to drug labeling that further limit use of the drug products and establishment of risk evaluation and mitigation strategies ("REMS"), measures that may, for instance, place restrictions on the distribution of new drug products. The increased attention to drug safety issues may result in a more cautious approach by the FDA to clinical trials. Data from clinical trials may receive greater scrutiny with respect to safety, which may make the FDA or other regulatory authorities more likely to delay or terminate clinical trials before completion, or require longer or additional clinical trials that may result in substantial additional expense and a delay or failure in obtaining approval or may result in approval for a more limited indication than originally sought.
Delays in the commencement, enrollment and completion of clinical trials, including but not limited to regulatory clinical holds, could increase our product development costs or limit the regulatory approval of our drug candidates. 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 trialstrials, including our CATT1 Phase 3 clinical trial, can be delayed for a variety of reasons, including:
•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;
•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;
•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; and
•difficulty in importing and exporting clinical trial materials and study samples.samples; and
•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 biopharmaceutical industry is characterized by intense competition and rapid technological innovation. Our potential competitors include large pharmaceutical and biotechnology companies, specialty pharmaceutical companies, generic orand biosimilar drug companies,manufacturers, universitiesuniversities, and other research institutions. Our drug candidates, if successfully developed and approved, willwould compete in crowded andhighly competitive markets.markets Inwith orderestablished totherapies. To compete with approved products,effectively, our drug candidates will need to demonstrate compelling advantages.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 areinclude efficacy, safety and tolerability profile, mechanism of action, controlpredictability and predictability,consistency of effect, convenience of dosingdosing, and price and reimbursement.
Oral Non-Insulin Agents
OralSeveral oral non-insulin agents that are currentlyin beingdevelopment developedor to treat type 1 diabetesapproved that may compete with cadisegliatin includefor the menintreatment inhibitorof BMF219type and1 TIXiMEDdiabetes ("T1D"). These include TIXiMED's TIX-100, a drug candidate that targetstargeting thioredoxin-interacting protein (TXNIP), a detrimental protein that is elevated in diabetes andthat leadshas tobeen associated with beta cell death and dysfunction. SGLT-2 inhibitorsinhibitors, such asincluding dapagliflozin (Farxiga) and ipragliflozin (Suglat), continuehave toreceived be approvedapproval in Japan for use in T1D but have not been approved for use in the USUnited States due to safety risksconcerns, including thosethe pertainingrisk toof 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
InjectableSeveral injectable agents are currently in development for the treatment of T1D. These include theZT-01, a somatostatin type 2 receptor blocker ZT-01being developed by Zucara toTherapeutics treatfor the treatment of nocturnal hypoglycemia, thehypoglycemia; dual GLP-1/GIP agonistreceptor CT-868agonists forin development by Carmot Therapeutics and Eli Lilly aimed at improving glycemic control in overweight or obese typeindividuals 1with diabetics,T1D; Diasome'sDiasome liver-targetingPharmaceuticals' liver-targeted HDV Lispro insulin,insulin; Adocia's ultrarapidultrarapid-acting acting biochaperoneBioChaperone insulin; asand wellvolagidemab, asa glucagon receptor antagonist being developed by REMD Biotherapeiutics Volagidemab Glucagon receptor Antagonist.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
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 aan FDA pprovedFDA-approved allogeneic islet cell transplant therapy indicated for patients with T1D who cannotare unable to achieve satisfactoryadequate glycemic control becausedue ofto frequentrecurrent severe hypoglycemia. The treatmentLantidra requires adjunctconcurrent immunosuppressive therapy to mitigateprevent organ rejection. Vertex Pharmaceuticals continues to developadvance stem cell-basedcell-derived therapiestherapies, including VX-880 (phase 3) and VX-264 (encapsulated beta cells, phase 1/2)VX-880, which areis plannedalso tointended befor useduse with or without concurrent immunosuppressive therapy,therapy. respectively.A Therenumber areof severaladditional Betabeta cell replacement programs currentlyare in development by companies including, but not limited to, Sernova, Seraxis, PolTreg, and Sana Biotechnology, whichutilizing arediverse inapproaches earlywith phasesthe 1/2goal of clinicaleliminating development.the need for chronic immunosuppression.
Medical Devices
Medical device technologytechnologies, such asincluding continuous glucose monitors, Smartsmart Connectedconnected Insulininsulin Penspen systemssystems, and automated insulin delivery systemssystems, continue to evolveadvance toand addressmay compete with pharmacological approaches by addressing glycemic control and reducing the reductionfrequency and severity of hypoglycemia.hypoglycemic events.
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. We cannot be sure whether additional legislative changes will be enacted, or whether the FDA regulations, guidance or interpretations will be changed, or what the impact of such changes on the marketing approvals of our drug candidates, if any, may be. In addition, increased scrutiny by the United States Congress of the FDA’s approval process may significantly delay or prevent marketing approval, as well as subject us and any future collaborators to more stringent drug labeling and post-marketing testing and other requirements.
Moreover, legislative and regulatory proposals have also been made to expand post-approval requirements and restrict sales and promotional activities for pharmaceutical drugs. We cannot be sure whether additional legislative changes will be enacted, or whether the FDA regulations, guidance or interpretations will be changed, or what the impact of such changes on the marketing approvals of our drug candidates, if any, may be. In addition, increased scrutiny by the United States Congress of the FDA’s approval process may significantly delay or prevent marketing approval, as well as subject us and any future collaborators to more stringent drug labeling and post-marketing testing and other requirements.
Risks Relating to Our DependenceFinancial onPosition Thirdand PartiesNeed for Additional Capital
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. 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.
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:
•aestablishing collaborationcollaborations partnerfor maythe notdevelopment devoteof sufficientcertain capital or resources towardsof our drug candidates;
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 10, 2026, there remains $47.5 million of availability under the TD Cowen ATM Offering. At no time will we sell shares of our Class A common stock under the General Instruction I.B.6 of Form S-3 in an aggregate amount exceeding one-third of our “public float” (the market value of our outstanding Class A common stock and any other equity securities held by non-affiliates) during any 12-calendar month period, so long as our public float remains below $75.0 million. 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.
•the limitednumber numberand characteristics of manufacturersdrug candidates that couldwe producepursue, including our drug candidates forin us;preclinical development;
We are a late-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 Our Dependence on Third Parties
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 not devote sufficient capital or resources towards our drug candidates;
•the limited number of manufacturers that could produce our drug candidates for us;
Our inability to obtain and maintain sufficient product liability insurance at an acceptable cost and scope of coverage to protect against potential product liability claims could prevent or inhibit the commercialization of any products we develop. We currently carry clinical trial liability insurance in the amount of $10.0 million in the aggregate. Although we maintain such insurance, any claim that may be brought against us could result in a court judgment or settlement in an amount that is not covered, in whole or in part, by our insurance or that is in excess of the limits of our insurance coverage. Our insurance policies also have various exclusions and deductibles, and we may be subject to a product liability claim for which we have no coverage. We will have to pay any amounts awarded by a court or negotiated in a settlement that exceed our coverage limitations or that are not covered by our insurance, and we may not have, or be able to obtain, sufficient capital to pay such amounts. Moreover, in the future, we may not be able to maintain insurance coverage at a reasonable cost or in sufficient amounts to protect us against losses. If and when we obtain approval for marketing for any drug product, we intend to expand our insurance coverage to include the sale of that product, however, we may be unable to obtain this liability insurance on commercially reasonable terms.
Our insurance policies also have various exclusions and deductibles, and we may be subject to a product liability claim for which we have no coverage. We will have to pay any amounts awarded by a court or negotiated in a settlement that exceed our coverage limitations or that are not covered by our insurance, and we may not have, or be able to obtain, sufficient capital to pay such amounts. Moreover, in the future, we may not be able to maintain insurance coverage at a reasonable cost or in sufficient amounts to protect us against losses. If and when we obtain approval for marketing for any drug product, we intend to expand our insurance coverage to include the sale of that product, however, we may be unable to obtain this liability insurance on commercially reasonable terms.
The use of new and evolving technologies, such as artificial intelligence, in our business may result in spending material resources and presents risks and challenges that can impact our business including by posing security and other risks to our confidential and/or proprietary information, including personal information, and as a result we may be exposed to reputational harm and liability.
We may use and integrate artificial intelligence, including generative artificial intelligence, into our business processes, and this innovation presents risks and challenges that could affect its adoption, and therefore our business. However, there can be no assurance that our use will enhance our business processes, or result in our business processes being more efficient or profitable. If we enable or offer solutions that draw controversy due to perceived or actual negative societal impact, we may experience brand or reputational harm, competitive harm or legal liability. For example, artificial intelligence technology can give rise to intellectual property risks, including compromises to proprietary intellectual property and intellectual property infringement. Algorithms may be flawed, insufficient, of poor quality, reflect unwanted forms of bias, or contain other errors or inadequacies, any of which may not be easily detectable; artificial intelligence has been known to produce false or “hallucinatory” inferences or outputs; artificial intelligence can present ethical issues and may subject us to new or heightened legal, regulatory, ethical, or other challenges; and inappropriate or controversial data practices by developers and end-users, or other factors adversely affecting public opinion of artificial intelligence, could impair the acceptance of artificial intelligence solutions, including those incorporated in our activities. If the artificial intelligence solutions that we create or use are deficient, inaccurate or controversial, we could incur operational inefficiencies, competitive harm, legal liability, brand or reputational harm, or other adverse impacts on our business and financial results. If we do not have sufficient rights to use the data or other material or content on which our artificial intelligence solutions or other artificial intelligence tools we use rely, we also may incur liability through the violation of applicable laws, third-party intellectual property, privacy or other rights, or contracts to which we are a party.
Affiliates of MacAndrews & Forbes Incorporated (together with its affiliates “MacAndrews”) and the investorinvestors that participated in the 2024 Private Placement and the 2025 Private Placement (together the "Private Placements,"; and such investors, the "Private Placement Investors,Investors"; and together with MacAndres,MacAndrews, our "Significant Investors") have substantial influence over our business, and their interests may differ from our interests or those of our other stockholders.
Our Significant Investors hold, directly or indirectly, a significant percentage of our combined voting power. Due to the Significant Investors' ownership and rights under the investor rights agreementagreements (as amended the "Investor Rights AgreementAgreements") with an affiliate of MacAndrews, the securities purchase agreementagreements (the "Securities Purchase AgreementAgreements") and registration rights agreementagreements (the "Registration Rights AgreementAgreements") with the Private Placement Investors, our Amended and Restated Certificate of Incorporation, as amended (the "Certificate of Incorporation") and Second Amended and Restated By-laws (the "By-laws"), the Significant Investors have substantial influence over us and our subsidiaries.
As of December 31, 2024,2025, MacAndrews andhad itsconverted affiliatesall 577,108 outstanding shares of our Class B common stock it had previously held 577,108(together non-votingwith commonan unitsequal number of vTv LLC (“vTv Units”units) andinto thean sameequal number of shares of vTv Therapeutics Inc.our Class BA common stockstock. Further, as well as an aggregate of 912,982December 31, 2025, MacAndrews directly or indirectly holds 1,490,090 shares of ourthe Company’s Class A common stock. As a result, MacAndrews and its affiliates held shares representing approximately 46.7%37.8% of the combined voting power of our outstanding common stock. Pursuant to the terms of the Exchange Agreement among the Company, vTv LLC and the holders of vTv Units party thereto (the “Exchange Agreement”), vTv Units (along with the corresponding number of shares of our Class B common stock) will be exchangeable for (i) shares of our Class A common stock on a one-for-one basis or (ii) cash (based on the market price of the shares of Class A common stock), at our option (as the managing member of vTv Therapeutics LLC). Shares of our Class A common stock issuable upon an exchange of vTv Units as described above would be considered “restricted securities,” as that term is defined in Rule 144 under the Securities Act, unless the exchange is registered under the Securities Act.
On February 27, 2024, we issued an aggregate of 464,377 shares of our Class A common stock to certain investors (the Private Placement Investors. As a result, the"2024 Private Placement Investors") holdin sharesthe representing2024 approximatelyPrivate 14.9%Placement, and in September 2025 we issued an aggregate of the682,018 combined voting powershares of our outstandingClass A common stock.stock Weto certain investors (the "2025 Private Placement Investors") in the 2025 Private Placement. On February 27, 2024, we also issued pre-funded warrants to purchase up to an aggregate of 3,853,997 shares of Class A common stock in the 2024 Private Placement. On March 5, 2024, we entered into an exchange agreement pursuant to which the 2024 Private Placement Investors exchanged an aggregate of 116,493 shares of our Class A common stock for pre-funded warrants to purchase 116,590 shares of our Class A common stock. In September 2025, we issued 4,561,714 pre-funded warrants and 5,243,732 common warrants in each case to purchase shares of our Class A common stock in the 2025 Private Placement. Such pre-funded warrants provide that each Private Placement Investor will not have the right to exercise any portion of its pre-funded warrant if, together with its affiliates, such Private Placement Investor would beneficially own in excess of 4.99% or 9.99%, as applicable, of the number of shares of our common stock outstanding immediately after giving effect to such exercise (the “Beneficial Ownership Limitation”); provided, however, that each Private Placement Investor may increase the Beneficial Ownership Limitation by giving 61 days’ notice to us, but not to any percentage in excess of 19.99%. As of December 31, 2025, the Private Placement Investors hold shares representing approximately 26.8% of the combined voting power of our outstanding common stock and 75.9% on a fully diluted basis.
On March 5, 2024, we entered into an exchange agreement pursuant to which the Private Placement Investors exchanged an aggregate of 116,493 shares for pre-funded warrants. As a result, following the exchange, the Private Placement Investors hold shares representing approximately 11.6% of the combined voting power of our outstanding common stock.
Additionally, we entered into the Securities Purchase AgreementAgreements and the Registration Rights AgreementAgreements with the Private Placement Investors providing certain governance and registration rights. Pursuant to the Registration Rights Agreements, we filed a shelf registration statement on Form S-3 in October 2025 to register certain shares previously issued to MacAndrews and other of the Private Placement Investors.
On February 23, 2024, the Board of Directors approved the adoption of an equity incentive plan (the "2024 Plan") to replace the existing 2015 Plan and the 2024 Plan was approved by the stockholders at our 2024 annual meeting of shareholders. The 2024 Plan authorizes us to issue equity awards relating to up to an additional 750,000 shares of our Class A Common Stock.Stock, subject to automatic annual increases as described in the 2024 Plan.
Management's Discussion & Analysis (MD&A)
Removed heading “Share-Based Compensation”
Largest changes
“To meet our future funding requirements into the first quarter of 2026, including funding the ongoing and future clinical trials of cadisegliatin (TTP399), we are evaluating several financing strategies, including direct equity investments and the potential licensing and monetization of other Company programs. The timing and availability of such additional financing are not yet known and we can provide no assurance that these plans will be successful. …”see in full comparison
“In addition to available cash and cash equivalents and available funds discussed above, 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 are evaluating several financing strategies to fund our planned and ongoing clinical trials, including direct equity investments and future public offerings of our common stock. The timing and availability of such additional financing are not yet known. …”see in full comparison
“Other Income (Expense), Net primarily consists of unrealized gains or losses attributable to the changes in fair value of the equity investments, the recognition of changes in fair value of the warrants to purchase shares of our Class A common stock, the loss from the G42 promissory note early redemption on February 28, 2023, the impairment charge from Anteris Bio, Inc. (“Anteris”) liquidation and dissolution and the Common Stock Repurchase Agreement (the "Repurchase Agreement") with Reneo Pharmaceuticals, Inc ("Reneo"), which was later acquired by OnKure in 2024.”see in full comparison
see in full comparisonOther income was immaterial for the year ended December 31, 2024.Other expense was$0.9$0.1 million for the year ended December 31,2023,2025 and was driven bythe recording of an impairment charge on a cost-method investment of $4.2 million offset by a realized gain of $3.1 million related to the Company’s Repurchase Agreement with Reneo as well as the gainslosses related to the change in the fair value of the outstanding warrants to purchase shares of our Class A commonstockstock.issuedOthertoincomerelatedwasparties.immaterial for the year December 31, 2024.
“Interest and penalties related to income taxes are included in the benefit (provision) for income taxes in our Consolidated Statement of Operations. We have not incurred any significant interest or penalties related to income taxes in any of the periods presented.”see in full comparison
Full comparison: every changed paragraph (39)
We are a late-stage biopharmaceutical company focused on developing oral, small molecule drug candidates intended to help treat people living with diabetes and other chronic diseases. The Company’s clinical pipeline is led by cadisegliatin, currently in a Phase 3 trial, a potential first-in-class oral liver-selective glucokinase activator (“GKA”) being investigated as an adjunctive therapy to insulin for the treatment of type 1 diabetes (“T1D”). The Company and its development partners are investigating multiple molecules across different indications for chronic diseases.
We are a clinical stage pharmaceutical company focused on treating metabolic and inflammatory diseases to minimize their long-term complications and improve the lives of patients. We have an innovative pipeline of first-in-class small molecule clinical and preclinical drug candidates. Our lead program is cadisegliatin (TTP399), an orally administered, small molecule, liver-selective glucokinase activator (“GKA”) as an adjunctive therapy to insulin for the treatment of type 1 diabetes ("T1D").
In January 2026, the Company received a $20.0 million upfront payment following the amended licensing agreement with Newsoara Biopharma Co., Ltd. for the Company’s highly selective PDE4 inhibitor, HPP737.
In March 2025, the Company announced that the clinical hold placed by the FDA in July 2024 on the cadisegliatin clinical program was lifted following the Company’s submission of a complete response letter.
•the scope, rate of progress and expense of our clinical trials once resumed as well as any additional, clinical trials and other research and development activities;
Interest income represents noncash interest income related to the imputed interest from the G42 Promissory Note receivable using the effective interest method and cash interest income from dividends and interest from our money market account,accounts, all of which are recognized in our Consolidated Statement of Operations.
Other Income (Expense), Income, Net
Other (expense) income primarily consists of the recognition of changes in fair value of the warrants to purchase shares of our Class A common stock.
Other Income (Expense), Net primarily consists of unrealized gains or losses attributable to the changes in fair value of the equity investments, the recognition of changes in fair value of the warrants to purchase shares of our Class A common stock, the loss from the G42 promissory note early redemption on February 28, 2023, the impairment charge from Anteris Bio, Inc. (“Anteris”) liquidation and dissolution and the Common Stock Repurchase Agreement (the "Repurchase Agreement") with Reneo Pharmaceuticals, Inc ("Reneo"), which was later acquired by OnKure in 2024.
There was no revenue for the year ended December 31, 2025. Revenue for the year ended December 31, 20242024, includes a $1.0 million increase to the transaction price for the license performance obligation under the Newsoara License Agreement due to the satisfaction of a development milestone and recognition of deferred Huadong revenue. There was no revenue for the year ended December 31, 2023.
Research and development expenses were $11.5$17.9 million and $13.6$11.5 million for the years ended December 31, 20242025 and 2023,2024, respectively. The decreaseincrease in research and development expenses during this period of approximately $2.0$6.3 million, or 15.1%,54.7%, was primarily driven by (i) lowerhigher spending on cadisegliatin of $4.2$5.4 million, due to decreases in toxicity studies and otherincreases clinical trial costs, drug manufacturing costs andstudies, (ii) other projects of $0.2 million, partially offset by (iii) an increase in indirect costs of $2.2$2.6 million primarily due to increases in payroll and bonus costs.costs and a $1.0 million Novo license milestone payment, partially offset by (iii) a decrease of $1.7 million in other projects primarily related to the write off of an aged accrual.
General and administrative expenses were $13.7$14.9 million and $11.9$13.7 million for the years ended December 31, 20242025 and 2023,2024, respectively. The increase in general and administrative expenses during this period of approximately $1.7$1.3 million, or 14.6%,9.5%, was primarily driven by (i) an increase in payrollshare-based costsexpense of $1.0$0.6 million, (ii) an increase in share-basedpayroll expensecosts of $0.8$0.4 million, (iii) an increase in legal expenses of $0.2 million, and (iv) an increase in other operating costs of $0.1 million, partially offset by (iv) a decrease of $0.2 million in legal expenses.million.
Interest income for the yearyears ended December 31, 2025 and December 31, 2024 of $1.9 million and $1.6 millionmillion, respectively, is related to interest and dividend income from our money market account. Interest income for the year ended December 31, 2023 of $0.5 million is related to the imputed interest on the G42 Promissory Note and dividend income from our money market account.
Other Income (Expense), Income, Net
Other income was immaterial for the year ended December 31, 2024. Other expense was $0.9$0.1 million for the year ended December 31, 2023,2025 and was driven by the recording of an impairment charge on a cost-method investment of $4.2 million offset by a realized gain of $3.1 million related to the Company’s Repurchase Agreement with Reneo as well as the gainslosses related to the change in the fair value of the outstanding warrants to purchase shares of our Class A common stockstock. issuedOther toincome relatedwas parties.immaterial for the year December 31, 2024.
Liquidity and Going Concern
On August 29, 2025, we entered into a securities purchase agreement (the “2025 Securities Purchase Agreement”) with the 2025 Private Placement Investors, pursuant to which we agreed to issue and sell 5,243,732 units (the “Units”) to the 2025 Private Placement Investors (the “2025 Private Placement”). Each Unit includes (i) either (A) one share (the “Shares”) of our Class A common stock at purchase price of $15.265 per share, (the “Common Stock”), or (B) a Pre-Funded Warrant (the “Pre-Funded Warrants”) to purchase one share of Common Stock (the “Pre-Funded Warrant Shares”) at a purchase price of $15.255 per share (representing the per-Share purchase price less the Pre-Funded Warrant's exercise price of $0.01) and (ii) a warrant (the “Common Warrants”) to purchase either (x) one share of Common Stock (the “Warrant Shares”) or (y) a Pre-Funded warrant to purchase one share of Common Stock (the “Replacement Warrants” and, together with the Pre-Funded Warrants and the Common Warrants, the “Warrants”). We received aggregate gross proceeds from the 2025 Private Placement of approximately $80.0 million, before deducting offering costs payable by us.
The Pre-Funded Warrants are exercisable for $0.01, at any time after their original issuance and will not expire. The common warrants are exercisable for (x) $22.71, if exercised for a Share, or (y) $22.70 if exercised for a Pre-Funded Warrant, at any time after their original issuance through their expiration date. The Common Warrants will expire upon the earlier to occur of (i) the fifth anniversary of the issuance of the Common Warrants and (ii) 90 days following the announcement of positive top-line data from the Company’s ongoing CATT1 clinical trial.
On January 30, 2026, the Company entered into a Second Amendment to License Agreement with Newsoara Biopharma Co., Ltd. (“Newsoara”) (the “Second Amendment”). Under the Second Amendment, Newsoara's rights in the Company's PDE4 inhibitor, HPP737, will expand to include all countries of the world upon Newsoara's payment of the upfront fee of $20.0 million. See Note 15 for further details.
On February 27, 2024, the Company closed a private placement financing of up to $51.0 million and additionally granted investors the right to purchase up to an additional $30.0 million of common stock up to 18 months following the closing of the private placement financing. The financing raised will allow the Company to further advance its lead program for cadisegliatin.
To meet our future funding requirements into the first quarter of 2026, including funding the ongoing and future clinical trials of cadisegliatin (TTP399), we are evaluating several financing strategies, including direct equity investments and the potential licensing and monetization of other Company programs. The timing and availability of such additional financing are not yet known and we can provide no assurance that these plans will be successful. If we are unable to raise additional capital as and when needed, or upon acceptable terms, such failure would have a significant negative impact on our financial condition. As such, these conditions raise substantial doubt about the Company’s ability to continue as a going concern.
In addition to available cash and cash equivalents and available funds discussed above, 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 are evaluating several financing strategies to fund our planned and ongoing clinical trials, including direct equity investments and future public offerings of our common stock. The timing and availability of such additional financing are not yet known. These factors raise substantial doubt about our ability to continue as a going concern.
On February 28, 2024, we entered into a sales agreement (the "TD Cowen Sales Agreement") with Cowen and Company, LLC (“TD Cowen”) pursuant to which we may offer and sell, from time to time, through or to TD Cowen, as sales agent or principal, shares of our Class A common stock having an aggregate offering price of up to $50.0 million, although we may only offer and sell under the TD Cowen ATM Offering up to one-third of the aggregate market value of our voting and non-voting common equity held by non-affiliates during any 12 calendar month period pursuant to General Instruction I.B.6 of Form S-3. We are not obligated to sell any shares under the TD Cowen Sales Agreement. Under the terms of the TD Cowen Sales Agreement, we will pay TD Cowen a commission of 3% of the aggregate proceeds from the sale of shares and reimburse certain legal fees or other disbursements. As of December 31, 2024,2025, we have sold 179,400 shares of Class A common stock under the TD Cowen ATM Offering for net proceeds of $2.5 million, leaving $47.5 million available to be sold. The shares are offered and sold pursuant to the Company’s shelf registration statement on Form S-3. InAt no eventtime will we sell shares of our Class A common stock under this registration statement within aan valueaggregate amount exceeding more than one-third of theour “public float” (the market value of our outstanding Class A common stock and any other equity securities that we may issue in the future that are held by non-affiliates) induring any 12-calendar month periodperiod, so long as our public float remains below $75$75.0 million.
We are evaluating several financing strategies to increase our cash reserves, including direct equity investments and the potential licensing and monetization of other Company programs. The timing and availability of such additional funding are not yet known and we can provide no assurance that these plans will be successful.
For the year ended December 31, 2024,2025, our net cash used in operating activities increaseddecreased by $6.2$0.1 million from the prior year. The significant contributor to the change in cash used during the year was working capital changes.
There were no cash flows from investing activities for the yearyears ended December 31, 2024.2025 For the year endedand December 31, 2023, net cash provided by investing activities was driven by the sale of our investments in Reneo.2024.
For the year ended December 31, 2025, net cash provided by financing activities was driven by sales of Units in the 2025 Private Placement for proceeds of $80.0 million . For the year ended December 31, 2024, net cash provided by financing activities was driven by sales of our Class A common stock and proceeds from pre-funded warrants in the 2024 Private Placement for proceeds of $51.0 millionmillion, from the Private Placement financing andplus proceeds from the TD Cowen ATM Offering of $2.5 million. For the year ended December 31, 2023, net cash provided by financing activities was driven by the receipt of proceeds of $12.0 million from the G42 Promissory Note early redemption.
•the progress, costs, results and timing of restartingenrollment and completion of our trials to evaluate cadisegliatin as a potential adjunctive therapy for the treatment of type 1 diabetes;
To the extent that we raise additional capital through the sale of equity or convertible debt securities, the ownership interests of our common 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 that will further limit or restrict 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. The Company’s current cash resources are expected to fund operations beyond the anticipated topline data readout from the CATT1 Phase 3 trial.
Income Taxes
In connection with the Initial Public Offering, vTv Therapeutics Inc. was formed. From August 1, 2015, vTv Therapeutics Inc. has been subject to corporate level income taxes. Prior to July 30, 2015, our predecessor entities were taxed as partnerships and all their income and deductions flowed through and were subject to tax at the partner level.
vTv Therapeutics Inc. holds vTv Units and is required to recognize deferred tax assets and liabilities for the difference between the financial reporting and tax basis of its investment in vTv LLC.
Our income tax expense, deferred tax assets and liabilities and reserves for unrecognized tax benefits reflect management’s best assessment of estimated future taxes to be paid. We are subject to income taxes in both the United States and various state jurisdictions. Significant judgments and estimates are required in determining the consolidated income tax expense.
We account for income taxes under the asset and liability method, which requires the recognition of deferred tax assets and liabilities for the expected future tax consequences of events included in the consolidated financial statements. Under this method, we determine deferred tax assets and liabilities on the basis of differences between the consolidated financial statement and tax bases of assets and liabilities by using enacted tax rates in effect for the year in which the differences are expected to reverse. The effect of a change in tax rates on deferred tax assets and liabilities is recognized in income in the period in which the enactment date occurs.
We recognize deferred tax assets to the extent we believe these assets are more-likely-than-not to be realized. In making such a determination, we consider all available positive and negative evidence, including future reversals of existing taxable temporary differences, projected future taxable income, tax planning strategies and recent results of operations.
We record uncertain tax positions on the basis of a two-step process in which (1) we determine whether it is more-likely-than-not that the tax positions will be sustained on the basis of the technical merits of the position and (2) for those tax positions meeting the more-likely-than-not recognition threshold, we recognize the largest amount of tax benefit that is more than 50% likely to be realized upon ultimate settlement with the related tax authority.
Interest and penalties related to income taxes are included in the benefit (provision) for income taxes in our Consolidated Statement of Operations. We have not incurred any significant interest or penalties related to income taxes in any of the periods presented.
Share-Based Compensation
Compensation expense for share-based compensation awards issued is based on the fair value of the award at the date of grant, and compensation expense is recognized for those awards earned over the service period. The grant date fair value of stock option awards is estimated using the Black-Scholes option pricing formula. Expected volatility is based on the historical volatility of the Company’s Class A common stock over the most recent period commensurate with the estimated expected term of the Company’s stock options offering period which is derived from historical experience. The risk-free rate is based on the U.S. Treasury yield curve in effect at the time of grant. Due to a lack of historical exercise data, we estimate the expected life of our outstanding stock options using the simplified method specified under Staff Accounting Bulletin Topic 14.D.2. The fair value of restricted stock units (“RSU”) grants is based on the market value of our Class A common stock on the date of grant. We also estimate the amount of share-based awards that are expected to be forfeited based on historical employee turnover rates.
What changed in the latest 10-Q
Risk Factors
Our risk factors are set forth under the heading “Risk Factors” under Item 1A of Part I in our Annual Report on Form 10-K for the year ended December 31, 2025.
Largest changes
Our risk factors are set forth under the heading “Risk Factors” under Item 1A of Part I in our Annual Report on Form 10-K for the year ended December 31, 2025.see in full comparisonThe Company disclosed material changes to our risk factors in our Quarterly Report on Form 10-Q for the quarter ended March 31, 2025, from those previously disclosed in our Annual Report on Form 10-K for the year ended December 31, 2025.
Full comparison: every changed paragraph (1)
Our risk factors are set forth under the heading “Risk Factors” under Item 1A of Part I in our Annual Report on Form 10-K for the year ended December 31, 2025. The Company disclosed material changes to our risk factors in our Quarterly Report on Form 10-Q for the quarter ended March 31, 2025, from those previously disclosed in our Annual Report on Form 10-K for the year ended December 31, 2025.
Management's Discussion & Analysis (MD&A)
New heading “Comparison of the six months ended June 30, 2026 and 2025”
New heading “Research and Development Expenses”
New heading “General and Administrative Expenses”
New heading “Interest income”
New heading “Other Income, Net”
Largest changes
On February 28, 2024, we entered into a sales agreement (the “TD Cowen Sales Agreement”) with Cowen and Company, LLC (“TD Cowen”), pursuant to which we may offer and sell, from time to time, through or to TD Cowen, as sales agent or principal, shares of our Class A commonsee in full comparisonstockstock, having an aggregate offering price of up to $50.0million,millionalthough we may only offer and sell under(the “TD Cowen ATM Offering”).up to one-third of the aggregate market value of our Class A common stock held by non-affiliates during any 12 calendar month period pursuantPursuant to General Instruction I.B.6 of FormS-3.S-3,Weatarenonottimeobligatedwilltowe sellanysecuritiessharesregisteredunderon the registration statement relating to the TD CowenSalesATMAgreement.Offering with an aggregate amount exceeding one-third of our public float in any 12-calendar month period, so long as our public float remains below $75.0 million. Under the terms of the TD Cowen Sales Agreement, we will pay TD Cowen a commission of3%3.0% of the aggregate proceeds from the sale of shares and reimburse certain legal fees or other disbursements.AsOnofSeptemberMarch17,31,2024,2026,thewe haveCompany sold 179,400 shares of Class A common stock under the TD Cowen ATM Offering for net proceeds of $2.5 million, leaving $47.5 million available to be sold. The shares are offered and sold pursuant to the Company’s shelf registration statement on Form S-3.At no time will we sell shares of our Class A common stock under this registration statement in an aggregate amount exceeding one-third of our “public float” (the market value of our Class A common stock and any other equity securities that we may issue in the future that are held by non-affiliates) in any 12-calendar month period, so long as our public float remains below $75.0 million.
Full comparison: every changed paragraph (35)
There have been no material developments since our last reporting period.
In January 2026, the Company entered into the Second Amendment to License Agreement (the "Second Amendment") to provide Newsoara Biopharma Co., Ltd. (“Newsoara”) with global rights to HPP737. In exchange for the global rights, Newsoara paid the Company an upfront amount of $20.0 million and agreed to modify the sales and development milestones and royalty on future sales. Under the Second Amendment, the Company is eligible to receive development, regulatory and sales-based milestone payments totaling up to $115.0 million as well as royalties on sales in the mid to upper single digits based on tiers of annual net sales of licensed products. Such royalties will be payable on a licensed product-by-licensed product and country-by-country basis until the latest of expiration of the licensed patents covering a licensed product in a country, expiration of data exclusivity rights for a licensed product in a country or a specified number of years after the first commercial sale of a licensed product in a country.
Under the terms of the Newsoara License Agreement, Newsoara will be responsible for the development and commercialization of the licensed products at its cost, and is required to use commercially reasonable efforts with respect to such development and commercialization efforts.
In May of 2023, the FDA issued new draft guidance on “Diabetes Mellitus: Efficacy Endpoints for Clinical Trials Investigating Antidiabetic Drugs and Biological Products” which, for the first time, permitted the use of hypoglycemia as an endpoint to support a label claim. Consistent with this guidance and with input from the FDA, we initiated our CATT1 trial to assess the effect of cadisegliatin on reducing the frequency of Level 2 hypoglycemia (blood glucose levels are less than 54 mg/dL or 3 mmol/L, regardless of symptoms) and Level 3 hypoglycemia (“severe” hypoglycemia e.g., requiring assistance of another person) in 150 patients with type 1 diabetes on a 1:1:1 basis (i.e., 50 patients per study arm) to receive 800 mg cadisegliatin daily, 800 mg cadisegliatin twice daily, or placebo. A key secondary endpoint is reduction in glycated hemoglobin (HbA1c) to assess the potential of cadisegliatin to reduce hyperglycemia. On July 26, 2024, the FDA issued a clinical hold for the cadisegliatin program, including the CATT1 trial, based on the discovery of a chromatographic signal in a recent human absorption, distribution, metabolism, and excretion (ADME) study of cadisegliatin that could not be resolved by standard mass spectroscopy. Following submission of a complete response by vTv to the FDA detailing additional research findings and the conclusion that the original chromatographic signal was an experimental artifact, the FDA removed the clinical hold on March 14, 2025. The Company also submitted a protocol amendment to shorten the overall duration of the CATT1 study from 12 months to 6 months with no change to the primary study endpoints. The CATT1 trial continues to enroll patients and the Company expects to complete enrollment of the CATT1 trial in the third quarter of 2026.
During 2025,this reporting period, we also continued working on the design and execution of supportive trials for cadisegliatin, including a thorough QT studystudy. andWe expect to initiate a Phase 2 study in patients with T1D using hybrid closed loop insulin infusion systems, which we expect to startsystems in late 2026.
Our research and development expenses by project for the three and six months ended MarchJune 31,30, 2026,2026 and 2025 were as follows (in thousands):
Other Income/(Expense),Income, net
Other income/(expense) primarily consists of the recognition of changes in fair value of the warrants to purchase shares of our Class A common stock.
Comparison of the three months ended MarchJune 31,30, 2026,2026 and 2025
There was no revenue for the three months ended June 30, 2026 and 2025.
Revenue of $36.8 million for the three months ended March 31, 2026 was related to the Newsoara upfront fee received and recognizing the deferred revenue of G42 license agreement due to the transfer of the related IP and satisfaction of the performance obligation. There was no revenue for the three months ended March 31, 2025.
Research and development expenses were $9.0$8.8 million and $2.8$4.1 million for the three months ended MarchJune 31,30, 2026,2026 and 2025, respectively. The increase in research and development expenses during this period of $6.1$4.7 million or 217.2%,113.7%, was primarily driven by i) an increase in spending on cadisegliatin and on other projects of $5.5$3.5 million due to increases in clinical studies and consulting related costs andcosts, ii) an increase in indirect research and development expense of $0.6$1.1 million primarily related to increases in payroll and share-based expenses.expenses and iii) an increase in other projects of $0.1 million.
General and administrative expenses were $4.6$5.2 million and $3.7$3.6 million for the three months ended MarchJune 31,30, 2026,2026 and 2025, respectively. The increase in general and administrative expenses during this period of $0.9$1.5 million, or 25.2%,42.6%, was primarily driven by i) increases of $0.4$0.6 million in share-based expenses, ii) increases of $0.3$0.5 million in other operating costs, iii) increases of $0.2 million in payroll related costs and iiiiv) increases of $0.2 million in legal expenses.
Interest income for the three months ended MarchJune 31,30, 2026,2026 and 2025, of $0.8 million and $0.3 million, respectively, is related to dividend income from our money market accounts.
Other Income/(Expense),Income, Net
Other income/(expense) for the three months ended MarchJune 31,30, 2026 and 2025, was immaterial.
Comparison of the six months ended June 30, 2026 and 2025
The following table sets forth certain information concerning our results of operations for the periods shown:
Revenue
Revenue of $36.8 million for the six months ended June 30, 2026 was related to the Newsoara upfront fee received and recognizing the deferred revenue of G42 license agreement due to the transfer of the related IP and satisfaction of the performance obligation. There was no revenue for the six months ended June 30, 2025.
Research and Development Expenses
Research and development expenses were $17.7 million and $6.9 million for the six months ended June 30, 2026 and 2025, respectively. The increase in research and development expenses during the period of $10.8 million, or 156.0%, was primarily driven by i) an increase in spending on cadisegliatin of $9.1 million due to increases in clinical studies and consulting related cost and ii) an increase in indirect research and development expense of $1.7 million primarily related to increases in payroll and share-based expenses.
General and Administrative Expenses
General and administrative expenses were $9.8 million and $7.3 million for the six months ended June 30, 2026 and 2025, respectively. The increase of $2.5 million or 33.8%, was primarily driven by i) increases of $0.9 million in share-based expenses, ii) increases of $0.7 million in other operating costs, iii) increases of $0.5 million in payroll related costs and iv) increases of $0.4 million in legal expenses.
Interest income
Interest income for the six months ended June 30, 2026 and 2025, of $1.7 million and $0.6 million respectively, is related to dividend income from our money market accounts.
Other Income, Net
Other income for the six months ended June 30, 2026 and June 30, 2025, was immaterial.
As of MarchJune 31,30, 2026, we had an accumulated deficit of $302.6$315.6 million. Since our inception, we have experienced a history of negative cash flows from operating activities. We anticipate that we will continue to incur losses and negative cash flow from operations for the foreseeable future as we continue our clinical trials. Further, we expect that we will need additional capital to continue to fund our operations. As of MarchJune 31,30, 2026, we had cash and cash equivalents of $98.1$86.6 million.
On August 29, 2025, we entered into a securities purchase agreement (the “Securities Purchase Agreement”) with certain institutional accredited investors (the “Private Placement Investors”), pursuant to which we agreed to issue and sell 5,243,732 units (the “Units”) to the Private Placement Investors in a private placement (the “Private Placement”). Each Unit includes (i) either (A) one share (the “Shares”) of our Class A common stock at purchase price of $15.265 per share, (the “Common Stock”), or (B) a Pre-Funded Warrant (the “Pre-Funded Warrants”) to purchase one share of Common Stock (the “Pre-Funded Warrant Shares”) at a purchase price of $15.255 per share (representing per Private Placement Share purchase price less the exercise price of $0.01) and (ii) a warrant (the “Common Warrants”) to purchase one share of Common Stock (the “Warrant Shares”) (or a Pre-Funded warrant to purchase one share of Common Stock in lieu of a share of Common Stock (the “Replacement Warrants” and,togetherand, together with the Pre-Funded Warrants and the Common Warrants, the “Warrants”). We received aggregate gross proceeds from the Private Placement of approximately $80.0 million, before deducting offering costs payable by us.
On February 28, 2024, we entered into a sales agreement (the “TD Cowen Sales Agreement”) with Cowen and Company, LLC (“TD Cowen”), pursuant to which we may offer and sell, from time to time, through or to TD Cowen, as sales agent or principal, shares of our Class A common stockstock, having an aggregate offering price of up to $50.0 million,million although we may only offer and sell under (the “TD Cowen ATM Offering”). up to one-third of the aggregate market value of our Class A common stock held by non-affiliates during any 12 calendar month period pursuantPursuant to General Instruction I.B.6 of Form S-3.S-3, Weat areno nottime obligatedwill towe sell anysecurities sharesregistered underon the registration statement relating to the TD Cowen SalesATM Agreement.Offering with an aggregate amount exceeding one-third of our public float in any 12-calendar month period, so long as our public float remains below $75.0 million. Under the terms of the TD Cowen Sales Agreement, we will pay TD Cowen a commission of 3%3.0% of the aggregate proceeds from the sale of shares and reimburse certain legal fees or other disbursements. AsOn ofSeptember March17, 31,2024, 2026,the we haveCompany sold 179,400 shares of Class A common stock under the TD Cowen ATM Offering for net proceeds of $2.5 million, leaving $47.5 million available to be sold. The shares are offered and sold pursuant to the Company’s shelf registration statement on Form S-3. At no time will we sell shares of our Class A common stock under this registration statement in an aggregate amount exceeding one-third of our “public float” (the market value of our Class A common stock and any other equity securities that we may issue in the future that are held by non-affiliates) in any 12-calendar month period, so long as our public float remains below $75.0 million.
For the threesix months ended MarchJune 31,30, 2026, our net cash providedused byin operating activities increaseddecreased by $14.8$8.5 million from the threesix months ended MarchJune 31,30, 2025. The significant contributor to the change was the $20.0 million received from the Newsoara upfront fee under the Second Amendment, partially offset by working capital changes.
There were no cash flows from investing activities for the threesix months ended MarchJune 31,30, 2026, and 2025.
There were no cash flows from financing activities for the threesix months ended MarchJune 31,30, 2026,2026. andFor 2025.the six months ended June 30, 2025, our net cash used in financing activities was immaterial.
As of MarchJune 31,30, 2026, we did not have outstanding any off-balance sheet arrangements as defined under SEC rules.
VTVT insider buying and selling (Form 4)
Since 2026-04-11, insiders reported open-market purchases in 0 Form 4 filings and open-market sales in 0 filings. Totals add up every open-market (code P and S) line in those filings, using the prices reported in the filings. Awards, option exercises, tax withholding and gifts are listed below but not counted.
No Form 4 stock transactions in this period.
Well-known investors holding VTVT (13F)
| Investor | Quarter | Shares | Reported value | % of their 13F | Change vs prior quarter |
|---|---|---|---|---|---|
| Millennium Management (Israel Englander) | 2026-06-30 | 269,874 | $10.2M | 0.01% | Added 31% |
| Renaissance Technologies | 2026-06-30 | 17,454 | $657.1K | 0.0% | New position |
| Two Sigma Investments | 2026-06-30 | 11,486 | $432.4K | 0.0% | New position |
| Point72 Asset Management (Steve Cohen) | 2026-06-30 | 5,947 | $223.9K | 0.0% | New position |
| Citadel Advisors (Ken Griffin) | 2026-06-30 | 5,906 | $222.4K | 0.0% | New position |