vTv Therapeutics Inc

Previous wording

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 iscadisegliatin(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”).

Current wording

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 iscadisegliatin, an orally administered, small molecule, liver-selective glucokinase activator (“GKA”) as an adjunctive therapy to insulin for the treatment of type 1 diabetes (“T1D”).

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In May of 2023, the FDA issued new draft guidance on "Diabetes Mellitus: Efficacy Endpoints for Clinical Trials Investigating Antidiabetic Drugs and Biological Products" which, for the first time, permitted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 have initiated a Phase 3 double-blind controlled 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. Participants in the trial will be randomized to two doses ofcadisegliatin or placebo. Reduction in glycated hemoglobin (HbA1c), a traditional efficacy endpoint in diabetes trials, is a key secondary endpoint to assess the potential ofcadisegliatin to reduce hyperglycemia, Following the initial assessment of efficacy after six months of treatment, participants will remain on trial for another six months to assess the durability of potential beneficial effects and safety. The study protocol was submitted to the FDA on February 29, 2024. The trial will be conducted in the U.S. only and is expected to complete enrollment by the fourth quarter in 2024 providing top line 1-year data by the first quarter in 2026.

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. 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 initiated activities to address the issue identified by FDA and restart clinical trial activities.

Previous wording

Concurrently, we will be working on the design for two international registrational studies forcadisegliatinin type 1 diabetes, which we expect to start in 2026.

Current wording

The Company continues to work on the design for two international registrational studies forcadisegliatinin type 1 diabetes, which we expect to start in 2026.

Previous wording

Our research and development expenses by project for the three months ended March 31, 2024 and 2023 were as follows (in thousands):

Current wording

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

Previous wording

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

Current 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;

Previous wording

Other expense/income primarily consists of unrealized gains or losses attributable to the changes in fair value of the equity investments in Reneo Pharmaceuticals, Inc ("Reneo"), the recognition of changes in fair value of the warrants to purchase shares of our Class A common stock held by related parties and the loss from the G42 promissory note early redemption on February 28, 2023.

Current wording

Other income (expense) primarily consists of unrealized gains or losses attributable to the changes in fair value of the equity investments in Reneo Pharmaceuticals, Inc. ("Reneo"), the recognition of changes in fair value of the warrants to purchase shares of our Class A common stock and the loss from the G42 promissory note early redemption on February 28, 2023.

Previous wording

Research and development expenses were $2.6 million and $3.9 million for the three months ended March 31, 2024 and 2023, respectively. The decrease in research and development expenses during this period of $1.3 million or 32.8%, was primarily driven by i) lower spending oncadisegliatinof $1.5 million, due to decreases in toxicity study costs and drug manufacturing related costs partially offset by increases in clinical trial start-up costs, and ii) an increase in indirect costs and other projects of $0.2 million.

Current wording

Research and development expenses were $3.4 million and $4.7 million for the three months ended June 30, 2024 and 2023, respectively. The decrease in research and development expenses during this period of $1.3 million or 26.7%, was primarily driven by i) lower spending oncadisegliatinof $2.0 million, due to decreases in toxicity study costs and drug manufacturing related costs partially offset by increases in clinical trial start-up costs, and ii) an increase in indirect costs and other projects of $0.7 million.

Previous wording

General and administrative expenses were $4.0 million and $3.5 million for the three months ended March 31, 2024 and 2023, respectively. The increase in general and administrative expenses during this period of $0.5 million, or 14.1%, was primarily driven by i) increases of $0.8 million in payroll related costs, ii) increases of $0.3 million in legal expenses, partially offset by iii) decreases of $0.5 million in other general and administrative costs, and iv) decreases of $0.1 million in share-based expense.

Current wording

General and administrative expenses were $3.7 million and $3.3 million for the three months ended June 30, 2024 and 2023, respectively. The increase in general and administrative expenses during this period of $0.4 million, or 12.3%, was primarily driven by i) increases of $0.3 million in share-based expense, ii) increases of $0.2 million in legal expenses, iii) increases of $0.1 million in payroll related costs, partially offset by iv) decreases of $0.2 million in other general and administrative costs.

Previous wording

Interest income for the three months ended March 31, 2024, of $0.1 million, is related to dividend income from our money market account. Interest income for the three months ended March 31, 2023, of$0.1 million, is related to imputed interest on the promissory notes.

Current wording

Interest income for the three months ended June 30, 2024, of $0.6 million, is related to dividend income from our money market accounts. Interest income for the three months ended June 30, 2023, of$0.2 million, is related to imputed interest on the promissory notes.

Previous wording

Other expense was $0.4 million for the three months ended March 31, 2024, and was driven bylosses related to the change in the fair value of the outstanding warrants to purchase shares of our own stock issued to related parties (“Related Party Warrants”). Other income was $1.6 million for the three months ended March 31, 2023, and was driven by an unrealized gain related to our investment in Reneo, losses related to the change in the fair value of the outstanding warrants to purchase shares of our stock issued to related parties and the loss from the G42 promissory note early redemption.

Current wording

Other income was $0.2 million for the three months ended June 30, 2024, and was driven bygains related to the change in the fair value of the outstanding warrants to purchase shares of our own stock. Other income was $0.6 million for the three months ended June 30, 2023, and was driven by an unrealized gain related to our investment in Reneo, as well as gains 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

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, 2023.

Current wording

Revenue for the six months ended June 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 three months ended June 30, 2023.

Previous wording

As of March 31, 2024, we had an accumulated deficit of $286.1 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 March 31, 2024, we had cash and cash equivalents of $52.3 million.

Current wording

As of June 30, 2024, we had an accumulated deficit of $291.3 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 June 30, 2024, we had cash and cash equivalents of $45.5 million.

Previous wording

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 Class A common stock 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.

Current wording

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 Class A common stock 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 June 30, 2024 we have not sold any shares pursuant to the TD Cowen Sales Agreement

Previous wording

For the three months ended March 31, 2024, our net cash used in operating activities increased by $2.2 million from the three months ended March 31, 2023. The significant contributor to the change in cash used during the year was working capital changes.

Current wording

For the six months ended June 30, 2024, our net cash used in operating activities increased by $2.7 million from the six months ended June 30, 2023. 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 three months ended March 31, 2024 and 2023.

Current wording

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

Previous 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. For the three months ended March 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.

Current wording

For the six months ended June 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. For the six months ended June 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.

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 intothe first quarter of 2026 through the use of our cash and cash equivalents and based on current operating plans, we are evaluating several financing strategies to fund the ongoing and 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

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.

Previous wording

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

Current wording

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

Previous 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;

Current 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;

Previous wording

•our ability to maintain control over our costs in line with our budget to complete the Phase 3 clinical trial for our lead product candidate, cadisegliatin;

Current wording

•our ability to maintain control over our costs in line with our budget for our lead product candidate, cadisegliatin;