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Item 7. Management’s Discussion and Analysis

2026-03-10 compared with 2025-03-20 · 38 added, 66 removed, 169 unchanged (38% of the section changed)

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Company Overview

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").

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.

Recent Developments

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.

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 .

Holding Company Structure

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This is due to the numerous risks and uncertainties associated with the development of our drug candidates, including:

• 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;

• the scope, rate of progress and expense of our clinical trials as well as any additional, clinical trials and other research and development activities;

• the potential benefits of our candidates over other therapies;

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General and administrative expenses consist primarily of salaries, benefits and related costs for employees in executive, finance, corporate development, human resources and administrative support functions.

Other significant general

and administrative expenses include accounting and legal services, expenses associated with obtaining and maintaining patents, cost of various consultants, occupancy costs and information systems.

Other significant general and administrative expenses include accounting and legal services, expenses associated with obtaining and maintaining patents, cost of various consultants, occupancy costs and information systems.

Interest Income

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, all of which are recognized in our Consolidated Statement of Operations .

Other Income (Expense), Net

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.

Interest income represents cash interest income from dividends and interest from our money market accounts, all of which are recognized in our Consolidated Statement of Operations.

Other (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.

Results of Operations

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Interest expense (6) — (6)

Other income (expense), net 10 (923) 933

Other (expense) income, net (136) 10 (146)

Loss before income taxes and noncontrolling interest (31,080) (22,605) (8,475)

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$ (26,974) $ (18,462) $ (8,512)

Revenue for the year ended December 31, 2024 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, 2025.

Revenue for the year ended December 31, 2024, 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.

Research and Development Expenses

Research and development expenses were $17.9 million and $11.5 million for the years ended December 31, 2025 and 2024, respectively.

The decrease in research and development expenses during this period of approximately $2.0 million, or 15.1%, was primarily driven by (i) lower spending on cadisegliatin of $4.2 million, due to decreases in toxicity studies and other clinical trial costs, drug manufacturing costs and (ii) other projects of $0.2 million, partially offset by (iii) an increase in indirect costs of $2.2 million due to increases in payroll and bonus costs.

The increase in research and development expenses during this period of approximately $6.3 million, or 54.7%, was primarily driven by (i) higher spending on cadisegliatin of $5.4 million, due to increases clinical studies, (ii) an increase in indirect costs of $2.6 million primarily due to increases in payroll and bonus 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

General and administrative expenses were $14.9 million and $13.7 million for the years ended December 31, 2025 and 2024, respectively.

The increase in general and administrative expenses during this period of approximately $1.7 million, or 14.6%, was primarily driven by (i) an increase in payroll costs of $1.0 million, (ii) an increase in share-based expense of $0.8 million, (iii) an increase in other operating costs of $0.1 million, partially offset by (iv) a decrease of $0.2 million in legal expenses.

The increase in general and administrative expenses during this period of approximately $1.3 million, or 9.5%, was primarily driven by (i) an increase in share-based expense of $0.6 million, (ii) an increase in payroll costs of $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.

Interest Income

Interest income for the year ended December 31, 2024 of $1.6 million 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), Net

Other income was immaterial for the year ended December 31, 2024.

Other expense was $0.9 million for the year ended December 31, 2023, 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 gains related to the change in the fair value of the outstanding warrants to purchase shares of our Class A common stock issued to related parties.

Interest income for the years ended December 31, 2025 and December 31, 2024 of $1.9 million and $1.6 million, respectively, is related to interest and dividend income from our money market account .

Other (Expense) Income, Net

Other expense was $0.1 million for the year ended December 31, 2025 and was driven by losses related to the change in the fair value of the outstanding warrants to purchase shares of our Class A common stock.

Other income was immaterial for the year December 31, 2024.

Liquidity and Capital Resources

Liquidity and Going Concern

As of December 31, 2025, we had an accumulated deficit of $326.7 million.

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As of December 31, 2025, we had cash and cash equivalents of $88.9 million.

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 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.

TD Cowen Sales Agreement

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The shares are offered and sold pursuant to the Company’s shelf registration statement on Form S-3.

In no event will we sell Class A common stock under this registration statement with a value exceeding more than one-third of the “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 million.

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 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.

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.

Year Ended December 31,

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Net cash used in operating activities $ (25,255) $ (25,307)

Net cash provided by investing activities — 4,404

Net cash provided by financing activities 77,441 52,607

Net increase (decrease) in cash and cash equivalents $ 27,300 $ (2,680)

Net increase in cash and cash equivalents $ 52,186 $ 27,300

Operating Activities

For the year ended December 31, 2024, our net cash used in operating activities increased by $6.2 million from the prior year.

For the year ended December 31, 2025, our net cash used in operating activities decreased by $0.1 million from the prior year.

The significant contributor to the change in cash used during the year was working capital changes.

Investing Activities

There were no cash flows from investing activities for the year ended December 31, 2024 .

For the year ended December 31, 2023, net cash provided by investing activities was driven by the sale of our investments in Reneo.

There were no cash flows from investing activities for the years ended December 31, 2025 and December 31, 2024 .

Financing Activities

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 of $51.0 million from the Private Placement financing and 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.

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 pre-funded warrants in the 2024 Private Placement for proceeds of $51.0 million, plus proceeds from the TD Cowen ATM Offering of $2.5 million.

Future Funding Requirements

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

• the progress, costs, results and timing of restarting our trials to evaluate cadisegliatin as a potential adjunctive therapy for the treatment of type 1 diabetes;

• the progress, costs, results and timing of enrollment and completion of our trials to evaluate cadisegliatin as a potential adjunctive therapy for the treatment of type 1 diabetes;

• the willingness of the FDA to rely upon our completed and planned clinical and preclinical studies and other work, as the basis for review and approval of our drug candidates;

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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.

Off-Balance Sheet Arrangements

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Prepaid expenses are recognized as expense in the statements of operations as we receive the related goods or services.

In connection with the Initial Public Offering, vTv Therapeutics Inc.

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.

Effect of Recent Accounting Pronouncements

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Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-K

Item 7. Management’s Discussion and Analysis