vTv Therapeutics Inc

Previous wording

The following table summarizes our drug candidates†, their partnership status and their respective stages of development:

Current wording

The following table summarizes our current drug candidates and their respective stages of development::

Previous wording

In May of 2023, the FDA issued new draft guidance on "Diabetes Mellitus: Efficacy Endpoints for Clinical Trials Investigating Antidiabetic Drugs and Biological Products" which, for the first time, permitted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 ofcadisegliatin 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 July 26, 2024, the FDA issued a clinical hold for thecadisegliatin program, including the CATT1 trial, based on the discovery of a chromatographic signal in a recent human absorption, distribution, metabolism, and excretion (ADME) study ofcadisegliatin that could not be resolved by standard mass spectroscopy. The FDA will require a single in vitro study to characterize this signal before thecadisegliatin program, including the CATT1 trial, can resume. At the time of the clinical hold, no patient had been dosed in the CATT1 trial and past clinical studies did not reveal any clinically concerning safety issues. The Company has conducted activities to address the issue identified by FDA and restart clinical trial activities.

Current wording

In May of 2023, the FDA issued new draft guidance on "Diabetes Mellitus: Efficacy Endpoints for Clinical Trials Investigating Antidiabetic Drugs and Biological Products" which, for the first time, permitted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 ofcadisegliatin 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 July 26, 2024, the FDA issued a clinical hold for thecadisegliatin program, including the CATT1 trial, based on the discovery of a chromatographic signal in a recent human absorption, distribution, metabolism, and excretion (ADME) study ofcadisegliatin 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 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. Based upon the shortened duration of the trial, the Company expects to have top-line data from the CATT1 study in the second half of 2026. In May 2025, the Company screened the first subject in the reinitiated study.

Previous wording

Our research and development expenses by project for the three and nine months ended September 30, 2024 and 2023 were as follows (in thousands):

Current wording

Our research and development expenses by project for the three months ended March 31, 2025 and 2024 were as follows (in thousands):

Previous wording

•the uncertainty of the duration of the clinical hold placed on thecadisegliatin program and 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;

Current wording

•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;

Previous wording

Interest income represents noncash interest income related to the imputed interest from the G42 Promissory Note receivable using the effective interest method, which ended in 2023, and cash interest income from dividends and interest from our money market account, all of which are recognized in our Condensed Consolidated Statement of Operations.

Current wording

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

Previous wording

Other income (expense) primarily consists of unrealized gains or losses attributable to the changes in fair value of the equity investments in OnKure, 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 and the impairment charge from Anteris Bio, Inc. (“Anteris”) liquidation and dissolution..

Current wording

Other expense primarily consists of the recognition of changes in fair value of the warrants to purchase shares of our Class A common stock.

Previous wording

Revenue for the nine months ended September 30, 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. There was no revenue for the nine months ended September 30, 2023.

Current wording

Revenue for the three months ended March 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 milestones. There was no revenue for the three months ended March 31, 2025.

Previous wording

Research and development expenses were $3.2 million and $2.8 million for the three months ended September 30, 2024 and 2023, respectively. The increase in research and development expenses during this period of $0.4 million or 14.2%, was primarily driven by i) an increase in indirect costs and other projects of $0.7 million and offset by ii) lower spending oncadisegliatinof $0.3 million, due to decreases in toxicity study costs and drug manufacturing related costs partially offset by increases in clinical trial start-up costs.

Current wording

Research and development expenses were $2.8 million and $2.6 million for the three months ended March 31, 2025 and 2024, respectively. The increase in research and development expenses during this period of $0.2 million or 6.8%, was primarily driven by i) an increase in indirect research and development expense of $0.9 million, partially offset by ii) lower spending oncadisegliatinof $0.6 million, due to decreases in clinical trial costs and drug manufacturing related costs and iii) lower spending on other projects of $0.1 million.

Previous wording

General and administrative expenses were $3.3 million and $2.5 million for the three months ended September 30, 2024 and 2023, respectively. The increase in general and administrative expenses during this period of $0.7 million, or 29.0%, was primarily driven by i) increases of $0.3 million in share-based expense, ii) increases of $0.2 million in legal expenses and iii) increases of $0.2 million in payroll related costs.

Current wording

General and administrative expenses were $3.7 million and $4.0 million for the three months ended March 31, 2025 and 2024, respectively. The decrease in general and administrative expenses during this period of $0.3 million, or 7.7%, was primarily driven by i) decreases of $0.4 million in payroll related costs, ii) decreases of $0.2 million in legal expenses, and iii) decreases of $0.1 million in other operating costs, partially offset by iv) increases of $0.4 million in share-based expense.

Previous wording

Interest income for the three months ended September 30, 2024, of $0.5 million, is related to dividend income from our money market accounts. Interest income for the three months ended September 30, 2023, of$0.1 million, is related to dividend income from our money market account.

Current wording

Interest income for the three months ended March 31, 2025, of $0.3 million, is related to dividend income from our money market accounts. Interest income for the three months ended March 31, 2024, of$0.1 million, is related to dividend income from our money market account.

Previous wording

Other expense for the nine months ended September 30, 2024 was immaterial. Other expense was $1.1 million for the nine months ended September 30, 2023, and was driven by an impairment charge on a cost-method investment of $4.2 million. This was partially offset by an unrealized gain from the Company’s investment in OnKure and gains from changes in the fair value of warrants to purchase shares of our own stock issued to related parties.

Current wording

Other expense for the three months ended March 31, 2025, was immaterial. Other expense of $0.4 million for the three months ended March 31, 2024, was driven by losses related to the change in the fair value of the outstanding warrants to purchase shares of our own stock issued to related parties.

Previous wording

As of September 30, 2024, we had an accumulated deficit of $296.1 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 September 30, 2024, we had cash and cash equivalents of $41.6 million.

Current wording

As of March 31, 2025, we had an accumulated deficit of $304.8 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 March 31, 2025, we had cash and cash equivalents of $31.1 million.

Previous wording

For the nine months ended September 30, 2024, our net cash used in operating activities increased by $4.3 million from the nine months ended September 30, 2023. The significant contributor to the change in cash used during the year was working capital changes.

Current wording

For the three months ended March 31, 2025, our net cash used in operating activities decreased by $1.6 million from the three months ended March 31, 2024. The significant contributor to the change in cash used during the year was working capital changes.

Previous wording

There were no cash flows from investing activities for the nine months ended September 30, 2024 and 2023.

Current wording

There were no cash flows from investing activities for the three months ended March 31, 2025 and 2024.

Previous wording

For the nine months ended September 30, 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 nine months ended September 30, 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.

Current wording

For the three months ended March 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. There were no cash flows from financing activities for the three months ended March 31, 2025

Previous wording

Based on our current operating plan, we believe that our current cash and cash equivalents will allow us to meet our liquidity requirements for at least the next twelve months. We plan to finance our operations through the use of our cash and cash equivalents, including funding activities needed to lift the clinical hold and resume the CATT1 trial. We continue to evaluate financing strategies to fund future clinical trials ofcadisegliatin, including direct equity investments and the potential licensing and monetization of other Company programs. The timing of any such transactions is not certain, and we may not be able to complete such transactions on acceptable terms, or at all. Even if we are able to complete such transactions, they may contain restrictions on our operations or cause substantial dilution to our stockholders. We have based our estimates on assumptions that may prove to be wrong, and we may use our available capital resources sooner than we currently expect. Because of the numerous risks and uncertainties associated with the development and commercialization of our drug candidates, we are unable to estimate the amounts of increased capital outlays and operating expenditures necessary to complete the development of our drug candidates. Additionally, we may rely on our ability to sell shares of our Class A common stock pursuant to the ATM Offering. However, the 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 the Company’s Class A common stock.

Current wording

We plan to finance our operations through the use of our cash and cash equivalents, including cash received from future funding activities. We continue to evaluate financing strategies to fund future clinical trials ofcadisegliatin, including direct equity investments and the potential licensing and monetization of other Company programs. The timing of any such transactions is not certain, and we may not be able to complete such transactions on acceptable terms, or at all. Even if we are able to complete such transactions, they may contain restrictions on our operations or cause substantial dilution to our stockholders. We have based our estimates on assumptions that may prove to be wrong, and we may use our available capital resources sooner than we currently expect. Because of the numerous risks and uncertainties associated with the development and commercialization of our drug candidates, we are unable to estimate the amounts of increased capital outlays and operating expenditures necessary to complete the development of our drug candidates. Additionally, although we may sell shares of our Class A common stock pursuant to the TD Cowen ATM Offering, 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 the Company’s Class A common stock.

Previous wording

•the willingness of the FDA to lift the clinical hold and 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;

Current wording

•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;