vTv Therapeutics Inc.

Previous wording

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 bycadisegliatin, 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.

Current wording

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, a potential first-in-class oral liver-selective glucokinase activator (“GKA”), currently being investigated in a Phase 3 trial 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.

Previous wording

Type 1 diabetes (“T1D”) is an autoimmune disease in which the body’s immune system destroys the insulin-producing beta cells of the pancreas. According to the T1D Index, an estimated 1.5 million individuals live with T1D in the United States as of 2026. Patients with T1D have difficulty achieving and maintaining glycemic control, defined as HbA1c <7% as recommended by the American Diabetes Association (“ADA”), with approximately 75% of Americans living with T1D not achieving this target. Blood sugar management is a constant balancing act between reducing hyperglycemia while avoiding hypoglycemia, which the ADA Standard of Care 2026 identifies as often the major limiting factor in the glycemic management of T1D.

Current wording

Type 1 diabetes (“T1D”) is an autoimmune disease in which the body’s immune system destroys the insulin-producing beta cells of the pancreas. According to the Centers for Disease Control and Prevention, approximately two million individuals live with T1D in the United States as of 2026. Patients with T1D have difficulty achieving and maintaining glycemic control, defined as HbA1c <7% as recommended by the American Diabetes Association (“ADA”), with approximately 75% of Americans living with T1D not achieving this target. Blood sugar management is a constant balancing act between reducing hyperglycemia while avoiding hypoglycemia. The Updated 2026 Consensus Report by the American Diabetes Association (“ADA”) and the European Association for the Study of Diabetes (“EASD”) on the Management of Type 1 Diabetes in Adults identifies hypoglycemia as the major limiting factor in the glycemic management of T1D.

Previous wording

Cadisegliatin is a novel, small-molecule, liver-selective glucokinase activator (“GKA”) being evaluated as a potential first-in-class oral adjunctive therapy to insulin for the treatment of T1D. Glucokinase is a key regulator of glucose homeostasis that acts as a physiological glucose sensor; liver-selective activation of glucokinase could improve overall blood glucose control and reduce the frequency of hypoglycemic episodes through a mechanism of action distinct from currently marketed oral anti-diabetic drugs. 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 T1D, supported by the positive results from the Phase 2 SimpliciT-1 study.

Current wording

Cadisegliatin is a novel, small-molecule, liver-selective glucokinase activator (“GKA”) being evaluated as a potential first-in-class oral adjunctive therapy to insulin for the treatment of T1D. Glucokinase is a key regulator of glucose homeostasis that acts as a physiological glucose sensor; liver-selective activation of glucokinase could improve overall blood glucose control and reduce the frequency of hypoglycemic episodes through a mechanism of action distinct from currently marketed oral anti-diabetic drugs. The U.S. Food and Drug Administration (“FDA”) granted Breakthrough Therapy designation in 2021 for cadisegliatin as an adjunctive therapy to insulin for the treatment of T1D, supported by the positive results from the Phase 2 SimpliciT-1 study.

Previous 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.

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 of cadisegliatin 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 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. The Company expects to complete enrollment of the CATT1 trial in the third quarter 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 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 a planned 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. In October 2026, we announced the completion of enrollment in the CATT1 trial, with a total of 166 patients randomized, and we expect to report topline results in mid-2027.

Previous wording

In 2025, the Company completed a food effect study in healthy volunteers that investigated the effect of fasting, low fat, and high fat meals on the absorption ofcadisegliatin. The study showed significantly higher cadisegliatin exposure in the fed groups as compared to the fasted group. The results confirm the current recommendation in the CATT1 trial that cadisegliatin be taken with food to maximize its absorption.

Current wording

In 2025, the Company completed a food effect study in healthy volunteers that investigated the effect of fasting, low fat, and high fat meals on the absorption of cadisegliatin. The study showed significantly higher cadisegliatin exposure in the fed groups as compared to the fasted group. The results confirm the current recommendation in the CATT1 trial that cadisegliatin be taken with food to maximize its absorption.

Previous 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.

Current wording

During the reporting period, we continued working on the design and execution of supportive trials for cadisegliatin, including a thorough QT study. The Company also continues to work on the design for further registrational studies for cadisegliatin in type 1 diabetes, which we expect to start in 2027.

Previous 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.

Current wording

In December 2025, together with our partner, G42 Healthcare Research Technology Projects LLC, 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 of cadisegliatin as an adjunct therapy to insulin in patients with T2D, and is now expected to start screening in the second half of 2027.

Previous wording

Our research and development expenses by project for the three and six months ended June 30, 2026 and 2025 were as follows (in thousands):

Current wording

Our research and development expenses by project for the three and nine months ended September 30, 2026 and 2025 were as follows (in thousands):

Previous wording

We plan to continue to incur significant research and development expenses for the foreseeable future as we continue the development ofcadisegliatinand further advance the development of our other drug candidates, subject to the availability of additional funding.

Current wording

We plan to continue to incur significant research and development expenses for the foreseeable future as we continue the development of cadisegliatin and further advance the development of our other drug candidates, subject to the availability of additional funding.

Previous wording

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

Previous wording

Research and development expenses were $8.8 million and $4.1 million for the three months ended June 30, 2026 and 2025, respectively. The increase in research and development expenses during this period of $4.7 million or 113.7%, was primarily driven by i) an increase in spending oncadisegliatin of $3.5 million due to increases in clinical studies and consulting related costs, ii) an increase in indirect research and development expense of $1.1 million primarily related to increases in payroll and share-based expenses and iii) an increase in other projects of $0.1 million.

Current wording

Research and development expenses were $7.5 million and $7.0 million for the three months ended September 30, 2026 and 2025, respectively. The increase in research and development expenses during this period of $0.5 million or 7.3%, was primarily driven by i) an increase in spending on cadisegliatin of $0.7 million due to increases in clinical studies and consulting related costs, partially offset by ii) a decrease in indirect research and development expense and other projects of $0.2 million.

Previous wording

General and administrative expenses were $5.2 million and $3.6 million for the three months ended June 30, 2026 and 2025, respectively. The increase in general and administrative expenses during this period of $1.5 million, or 42.6%, was primarily driven by i) increases of $0.6 million in share-based expenses, ii) increases of $0.5 million in other operating costs, iii) increases of $0.2 million in payroll related costs and iv) increases of $0.2 million in legal expenses.

Current wording

General and administrative expenses were $4.9 million and $3.7 million for the three months ended September 30, 2026 and 2025, respectively. The increase in general and administrative expenses during this period of $1.2 million, or 33.1%, was primarily driven by i) increases of $0.6 million in share-based expenses, ii) increases of $0.4 million in other operating costs, and iii) increases of $0.2 million in payroll related costs.

Previous wording

Interest income for the three months ended June 30, 2026 and 2025, of $0.8 million and$0.3 million, respectively, is related to dividend income from our money market accounts.

Current wording

Interest income for the three months ended September 30, 2026 and 2025, of $0.7 million and$0.4 million, respectively, is related to dividend income from our money market accounts.

Previous wording

Other income for the three months ended June 30, 2026 and 2025, was immaterial.

Current wording

Other income (expense), net for the three months ended September 30, 2026 and 2025, was immaterial.

Previous wording

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.

Current wording

Revenue of $36.8 million for the nine months ended September 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 nine months ended September 30, 2025.

Previous wording

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 oncadisegliatinof $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.

Current wording

Research and development expenses were $25.3 million and $14.0 million for the nine months ended September 30, 2026 and 2025, respectively. The increase in research and development expenses during the period of $11.3 million, or 81.2%, was primarily driven by i) an increase in spending on cadisegliatin of $9.8 million due to increases in clinical studies and consulting related cost and ii) an increase in indirect research and development expense of $1.5 million primarily related to increases in payroll and share-based expenses.

Previous wording

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.

Current wording

General and administrative expenses were $14.7 million and $11.0 million for the nine months ended September 30, 2026 and 2025, respectively. The increase of $3.7 million or 33.6%, was primarily driven by i) increases of $1.6 million in share-based expenses, ii) increases of $1.0 million in other operating costs, iii) increases of $0.7 million in payroll related costs and iv) increases of $0.4 million in legal expenses.

Previous wording

Interest income for the six months ended June 30, 2026 and 2025, of $1.7 million and $0.6 million respectively, is related todividend income from our money market accounts.

Current wording

Interest income for the nine months ended September 30, 2026 and 2025, of $2.4 million and $1.0 million respectively, is related todividend income from our money market accounts.

Previous wording

Other income for the six months ended June 30, 2026 and June 30, 2025, was immaterial.

Current wording

Other income (expense), net for the nine months ended September 30, 2026 and September 30, 2025, was immaterial.

Previous wording

As of June 30, 2026, we had an accumulated deficit of $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 June 30, 2026, we had cash and cash equivalents of $86.6 million.

Current wording

As of September 30, 2026, we had an accumulated deficit of $327.2 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, 2026, we had cash and cash equivalents of $77.2 million.

Previous wording

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 3 for further details.

Current wording

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, expanded to include all countries of the world upon Newsoara's payment of the upfront fee of $20.0 million. See Note 3, “Collaboration Agreements,” to the Unaudited Condensed Consolidated Financial Statements.

Previous wording

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, 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.

Current wording

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 included (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, 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.

Previous wording

For the six months ended June 30, 2026, our net cash used in operating activities decreased by $8.5 million from the six months ended June 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.

Current wording

For thenine months ended September 30, 2026, our net cash used in operating activities improved by $3.5 million from thenine months ended September 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.

Previous wording

There were no cash flows from investing activities for the six months ended June 30, 2026, and 2025.

Current wording

There were no cash flows from investing activities for the nine months ended September 30, 2026, and 2025.

Previous 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.

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 of cadisegliatin, 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 and limitations under federal securities laws.

Previous wording

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

Current wording

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