vTv Therapeutics Inc.
For the period ended Sep 30, 2025. Filed Nov 6, 2025.
View on SEC.govAbout this filing
A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.
Sep 30, 2025 · Filed Nov 6, 2025
VTVT$21.03-3.3%Stored close · as of Nov 6, 2026
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2025-06-30; filed 2025-08-12.
0001641489-25-000053
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2025-09-30; filed 2025-11-06.
0001641489-25-000060
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsThe baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.
Compared 108 previous paragraphs and 107 current paragraphs.
79 unchanged; 18 reworded; 10 added; 10 removed; 1 previous and 0 current paragraphs rearranged.
Tables are not compared: 4 previous and 4 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.
A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.
Added paragraphs (10)
Current report
There have been no material developments since our last reporting period.
Current report
In June 2025, the Company initiated a food effect study in healthy volunteers to assess the impact of low or high fats food on the pharmacokinetics ofcadisegliatin compared to fasting. The study completed the life phase and data are being analyzed currently.
Current report
Other (Expense)/Income, net
Current report
Other(Expense)/Income, Net
Current report
Comparison of the nine months ended September 30, 2025, and 2024
Current report
Other Expense Net
Current report
Other expense for the nine months ended September 30, 2025, and September 30, 2024, was immaterial.
Current report
Liquidity
Current report
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 report
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, after the original issuance through the termination date. The Common Warrants will expire upon the earlier to occur of (i) the fifth anniversary of the issuance of the Warrants and (ii) 90 days following the announcement of positive top-line data from the Company’s ongoing CATT1 clinical trial.
Removed paragraphs (10)
Previous report
In May 2025, the Company reinitiated screening of patients in its Phase 3 CATT1 clinical trial investigating cadisegliatin as a potential adjunctive therapy to insulin for the treatment of T1D. The Company continues to advance the trial and expects to have top line data from the trial in the second half of 2026.
Previous report
On May 19, 2025, the Company announced the appointment of Michael Tung, M.D., MBA as its Executive Vice President and Chief Financial Officer.
Previous report
In August 2025, the Company announced that the first study participant has been randomized in its CATT1 Phase 3 trial evaluating cadisegliatin as an adjunctive therapy to insulin for the treatment of T1D. Top-line data from the study is expected in the second half of 2026.
Previous report
In August 2025, the U.S. Patent and Trademark Office allowed claims covering the crystalline salt form ofcadisegliatin, strengthening the Company’s intellectual property portfolio.
Previous report
Other Income/(Expense), net
Previous report
Other Income, Net
Previous report
Comparison of the six months ended June 30, 2025 and 2024
Previous report
Other Income/(Expense) Net
Previous report
Liquidity and Going Concern
Previous report
On February 27, 2024, the Company closed a private placement financing of $51.0 million and additionally granting investors the right to purchase up to an additional $30.0 million of common stock 18 months following the closing of the private placement financing. The financing raised will allow the Company to further advance its lead program forcadisegliatin.
Reworded paragraphs (18)
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 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 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.
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. In May 2025, the Company screened the first subject in the reinitiated study, and randomized the first subject on August 6, 2025. In addition, the Company started a food effect study in healthy volunteers in June 2025, to be completed by the end of 2025.
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.
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 450 insulin-using patients with type 2 diabetes. We expect that trial to begin in the fourth quarter of 2025.
Current 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.
Previous wording
Our research and development expenses by project for the three and six months ended June 30, 2025 and 2024 were as follows (in thousands):
Current 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):
Previous 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.
Current 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.
Previous wording
Research and development expenses were $4.1 million and $3.4 million for the three months ended June 30, 2025 and 2024, respectively. The increase in research and development expenses during this period of $0.7 million or 19.3%, was primarily driven by i) an increase in indirect research and development expense of $0.8 million primarily related to payroll expense, partially offset by ii) lower spending oncadisegliatinand on other projects of $0.1 million.
Current 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.
Previous wording
General and administrative expenses were $3.6 million and $3.7 million for the three months ended June 30, 2025 and 2024, respectively. The decrease in general and administrative expenses during this period of $0.1 million, or 2.6%, was primarily driven by i) decreases of $0.3 million in other operating costs, partially offset by ii) increases of $0.2 million in payroll related costs.
Current 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.
Previous wording
Interest income for the three months ended June 30, 2025 and 2024, of $0.3 million and$0.6 million, respectively, is related to dividend income from our money market accounts.
Current 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.
Previous wording
Other income for the three months ended June 30, 2025, was immaterial. Other income of $0.2 million for the three months ended June 30, 2024, was driven by gains related to the change in the fair value of the outstanding warrants to purchase shares of our own stock.
Current wording
Other expense for the three months ended September 30, 2025, was immaterial. Other income of $0.2 million for the three months ended September 30, 2024, was driven by gains related to the change in the fair value of the outstanding warrants to purchase shares of our own stock.
Previous 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 six months ended June 30, 2025.
Current 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.
Previous wording
Research and development expenses were $6.9 million and $6.1 million for the six months ended June 30, 2025 and 2024, respectively. The increase in research and development expenses during the period of $0.8 million, or 13.9%, was primarily driven by i) increases in indirect costs and other projects of $1.7 million primarily related to payroll expense, partially offset by ii) lower spending oncadisegliatinof $0.7 million due to decreases in clinical study and drug manufacturing related costs and consulting fees, and iii) lower spending on other projects of $0.2 million.
Current wording
Research and development expenses were $14.0 million and $9.3 million for the nine months ended September 30, 2025, and 2024, respectively. The increase in research and development expenses during the period of $4.6 million, or 49.8%, was primarily driven by i) increases in indirect costs of $3.0 million primarily related to the Novo Nordisk license milestone accrual and increases in payroll, bonus and share-based expenses and ii) an increase in spending oncadisegliatinof $1.8 million due to increases in clinical studies, partially offset by iii) lower spending on other projects of $0.2 million.
Previous wording
General and administrative expenses were $7.3 million and $7.7 million for the six months ended June 30, 2025 and 2024, respectively. The decrease of $0.4 million or 5.2%, was primarily driven by i) decreases of $0.4 million in other general and administrative costs, ii) decreases of $0.2 million in payroll costs, iii) decreases of $0.2 million in legal expense, partially offset by iv) increases of $0.4 million in share-based expense.
Current wording
General and administrative expenses were $11.0 million and $11.0 million for the nine months ended September 30, 2025, and 2024, respectively. The decrease of $0.0 million or 0.1%, was primarily driven by i) decreases of $0.5 million in other general and administrative costs, partially offset by ii) increases of $0.5 million in share-based expense.
Previous wording
Interest income for the six months ended June 30, 2025 and 2024, of $0.6 million is related todividend income from our money market accounts.
Current wording
Interest income for the nine months ended September 30, 2025, and 2024 of $1.0 million and $1.1 million respectively, is related todividend income from our money market accounts.
Previous wording
As of June 30, 2025, we had an accumulated deficit of $310.9 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, 2025, we had cash and cash equivalents of $25.9 million.
Current 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.
Previous wording
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. 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.
Current wording
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.
Previous wording
For the six months ended June 30, 2025, our net cash used in operating activities decreased by $3.3 million from the six months ended June 30, 2024. The significant contributor to the change in cash used during the year was working capital changes.
Current 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.
Previous wording
There were no cash flows from investing activities for the six months ended June 30, 2025 and 2024.
Current wording
There were no cash flows from investing activities for the nine months ended September 30, 2025, and 2024.
Previous 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. Cash flows from financing activities for the six months ended June 30, 2025 were immaterial.
Current wording
For the nine months ended September 30, 2025, net cash provided by financing activities was driven by sales of our Class A common stock and proceeds from Pre-Funded and Common Warrants of $80.0 million from the Private Placement financing 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.
Rearranged previous paragraphs (1)
Previous report — wording carried elsewhere
Other income for the six months ended June 30, 2025, was immaterial. Other expense was $0.2 million for the six months ended June 30, 2024, and was driven by losses related to the change in the fair value of the outstanding warrants to purchase shares of our own stock.