vTv Therapeutics Inc.

Previous wording

The U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy designation in 2021 forcadisegliatin as an adjunctive therapy to insulin for the treatment of type 1 diabetes. The Breakthrough Therapy designation provides a sponsor with added support and the potential to expedite development and review timelines for a promising new investigational medicine. The Breakthrough Therapy designation forcadisegliatin in T1D was supported by the positive results from the Phase 2 SimpliciT-1 study, a multi-center, randomized, double-blind, adaptive study assessing the safety and efficacy ofcadisegliatinas an adjunct to insulin therapy in adults with T1D. In this trial, treatment with cadisegliatin resulted in a statistically significant improvement in HbA1c relative to placebo and a clinically meaningful decrease (40%) in the frequency of severe and symptomatic hypoglycemia. Cadisegliatin demonstrated a favorable safety profile, in which abnormal levels of serum or urine ketones were detected less frequently in patients taking cadisegliatin than those taking placebo.

Current wording

In the Phase 2 SimpliciT-1 study, a multi-center, randomized, double-blind, adaptive trial, treatment with cadisegliatin resulted in a statistically significant improvement in HbA1c relative to placebo and a clinically meaningful decrease (40%) in the frequency of severe and symptomatic hypoglycemia. Cadisegliatin demonstrated a favorable safety profile, in which abnormal levels of serum or urine ketones were detected less frequently in patients taking cadisegliatin than those taking placebo. A Phase 1 mechanistic study further demonstrated no increased risk of ketoacidosis with cadisegliatin during acute insulin withdrawal in patients with T1D. We have completed eleven Phase 1 and three Phase 2 clinical trials ofcadisegliatin totaling more than 500 patients with type 1 and type 2 diabetes.

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In May of 2023, the FDA issued new draft guidance on “Diabetes Mellitus: Efficacy Endpoints for Clinical Trials Investigating Antidiabetic Drugs and Biological Products” which, for the first time, permitted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. 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.

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 a 1:1:1 basis (i.e., 50 patients per study arm) to receive 800 mgcadisegliatin daily, 800 mgcadisegliatin twice daily, or placebo. A key secondary endpoint is reduction in glycated hemoglobin (HbA1c) to assess the potential ofcadisegliatin to reduce hyperglycemia. 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 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 in the third quarter of 2026.

Previous wording

The Company continues to work on the design for further registrational studies forcadisegliatinin type 1 diabetes, which we expect to start in 2027.

Current wording

The Company continues to work on the design for further registrational studies forcadisegliatin in type 1 diabetes, which we expect to start in 2027.

Previous wording

In addition, we continue to work with our partner, G42 Investments AI Holding RSC Ltd. (“G42”), to initiate a double-blind, randomized, controlled Phase 2 trial in the Middle East region in insulin-using patients with type 2 diabetes (“T2D”). The study will randomize 300 patients to assess the potential ofcadisegliatin as an adjunct therapy to insulin in patients with T2D. We expect that trial to begin in the fourth quarter of 2025.

Current wording

In December 2025, together with our partner, G42 Investments (“G42”), we initiated a double-blind, randomized, controlled Phase 2 trial in the Middle East region in insulin-using patients with type 2 diabetes (“T2D”). The study will randomize 300 patients to assess the potential ofcadisegliatin as an adjunct therapy to insulin in patients with T2D, and is expected to start screening in 2026.

Previous wording

Our research and development expenses by project for the three and nine months ended September 30, 2025, and 2024 were as follows (in thousands):

Current wording

Our research and development expenses by project for the three months ended March 31, 2026, and 2025 were as follows (in thousands):

Previous wording

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.

Current wording

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.

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, 2025.

Current wording

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.

Previous wording

Research and development expenses were $7.0 million and $3.2 million for the three months ended September 30, 2025, and 2024, respectively. The increase in research and development expenses during this period of $3.8 million or 117.7%, was primarily driven by i) an increase in spending oncadisegliatinand on other projects of $2.4 million due to increases in clinical studies and drug manufacturing related costs and ii) an increase in indirect research and development expense of $1.4 million primarily related to the Novo Nordisk license milestone accrual and increases in payroll and share-based expenses.

Current wording

Research and development expenses were $9.0 million and $2.8 million for the three months ended March 31, 2026, and 2025, respectively. The increase in research and development expenses during this period of $6.1 million or 217.2%, was primarily driven by i) an increase in spending oncadisegliatinand on other projects of $5.5 million due to increases in clinical studies and consulting related costs and ii) an increase in indirect research and development expense of $0.6 million primarily related to increases in payroll and share-based expenses.

Previous wording

General and administrative expenses were $3.7 million and $3.3 million for the three months ended September 30, 2025, and 2024, respectively. The increase in general and administrative expenses during this period of $0.4 million, or 12.1%, was primarily driven by i) increases of $0.3 million in payroll related costs and ii) increases of $0.1 million in legal expenses.

Current wording

General and administrative expenses were $4.6 million and $3.7 million for the three months ended March 31, 2026, and 2025, respectively. The increase in general and administrative expenses during this period of $0.9 million, or 25.2%, was primarily driven by i) increases of $0.4 million in share-based expenses, ii) increases of $0.3 million in payroll related costs and iii) increases of $0.2 million in legal expenses.

Previous wording

Interest income for the three months ended September 30, 2025, and 2024, of $0.4 million and$0.5 million, respectively, is related to dividend income from our money market accounts.

Current wording

Interest income for the three months ended March 31, 2026, and 2025, of $0.8 million and$0.3 million, respectively, is related to dividend income from our money market accounts.

Previous wording

Other expense for the nine months ended September 30, 2025, and September 30, 2024, was immaterial.

Current wording

Other income/(expense) for the three months ended March 31, 2026 and 2025, was immaterial.

Previous wording

As of September 30, 2025, we had an accumulated deficit of $319.6 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 September 30, 2025, we had cash and cash equivalents of $98.5 million.

Current wording

As of March 31, 2026, we had an accumulated deficit of $302.6 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 March 31, 2026, we had cash and cash equivalents of $98.1 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. As of September 30, 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. 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.

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 March 31, 2026, 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. 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.

Previous wording

For the nine months ended September 30, 2025, our net cash used in operating activities decreased by $4.5 million from the nine months ended September 30, 2024. 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, 2026, our net cash provided by operating activities increased by $14.8 million from the three months ended March 31, 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.

Previous wording

There were no cash flows from investing activities for the nine months ended September 30, 2025, and 2024.

Current wording

There were no cash flows from investing activities for the three months ended March 31, 2026, and 2025.

Previous wording

This quarterly report includes certain forward-looking statements within the meaning of the federal securities laws regarding, among other things, our management’s intentions, plans, beliefs, expectations, or predictions of future events, which are considered forward-looking statements. You should not place undue reliance on those statements because they are subject to numerous uncertainties and factors relating to our operations and business environment, all of which are difficult to predict and many of which are beyond our control. Forward-looking statements include information concerning our possible or assumed future results of operations, including descriptions of our business strategy. These statements often include words such as “anticipates,” “believes,” “could,” “seeks,” “estimates,” “expects,” “intends,” “may,” “plans,” “potential,” “predicts,” “projects,” “should,” “will,” “would” or similar expressions and the negatives of those terms. These statements are based upon assumptions that we have made in light of our experience in the industry, as well as our perceptions of historical trends, current conditions, expected future developments and other factors that we believe are appropriate under the circumstances. As you read this quarterly report, you should understand that these statements are not guarantees of performance or results. They involve known and unknown risks, uncertainties, and assumptions, including those described under the heading “Risk Factors” under Item 1A of Part I in our Annual Report on Form 10-K and under Item 1A of Part II of this Quarterly Report on Form 10-Q. Although we believe that these forward-looking statements are based upon reasonable assumptions, you should be aware that many factors, including those described under the heading “Risk Factors” under Item 1A of Part I in our Annual Report on Form 10-K and under Item 1A of Part II of this Quarterly Report on Form 10-Q, could affect our actual financial results or results of operations and could cause actual results to differ materially from those in the forward-looking statements.

Current wording

This quarterly report includes certain forward-looking statements within the meaning of the federal securities laws regarding, among other things, our management’s intentions, plans, beliefs, expectations, or predictions of future events, which are considered forward-looking statements. You should not place undue reliance on those statements because they are subject to numerous uncertainties and factors relating to our operations and business environment, all of which are difficult to predict and many of which are beyond our control. Forward-looking statements include information concerning our possible or assumed future results of operations, including descriptions of our business strategy. These statements often include words such as “anticipates,” “believes,” “could,” “seeks,” “estimates,” “expects,” “intends,” “may,” “plans,” “potential,” “predicts,” “projects,” “should,” “will,” “would” or similar expressions and the negatives of those terms. These statements are based upon assumptions that we have made in light of our experience in the industry, as well as our perceptions of historical trends, current conditions, expected future developments and other factors that we believe are appropriate under the circumstances. As you read this quarterly report, you should understand that these statements are not guarantees of performance or results. They involve known and unknown risks, uncertainties, and assumptions, including those described under the heading “Risk