vTv Therapeutics Inc.
For the period ended Jun 30, 2025. Filed Aug 12, 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.
Jun 30, 2025 · Filed Aug 12, 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 2025-03-31; filed 2025-05-15.
0001641489-25-000026
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent 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 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 99 previous paragraphs and 108 current paragraphs.
71 unchanged; 20 reworded; 12 added; 8 removed; 0 previous and 5 current paragraphs rearranged.
Tables are not compared: 3 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 (12)
Current report
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 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.
Current 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.
Current 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.
Current 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.
Current report
Other Income/(Expense), net
Current report
Other Income, Net
Current report
Comparison of the six months ended June 30, 2025 and 2024
Current report
Revenue
Current report
Interest income
Current report
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 report
Other Income/(Expense) Net
Removed paragraphs (8)
Previous report
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”) in development as an adjunctive therapy to insulin for the treatment of type 1 diabetes (“T1D”).
Previous report
There have been no material developments since our last reporting period.
Previous report
Research and Development Expenses
Previous report
General and Administrative Expenses
Previous report
Other Expense, net
Previous report
Research and Development Expenses
Previous report
General and Administrative Expenses
Previous report
Other Expense, Net
Reworded paragraphs (20)
Previous wording
The following table summarizes our current drug candidates and their respective stages of development::
Current wording
The following table summarizes our current clinical development 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. 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.
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, 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.
Previous wording
The Company continues to work on the design for two international 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 forcadisegliatinin 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 450 insulin-using patients with type 2 diabetes. We expect that trial to begin in 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 450 insulin-using patients with type 2 diabetes. We expect that trial to begin in the fourth quarter of 2025.
Previous wording
Our research and development expenses by project for the three months ended March 31, 2025 and 2024 were as follows (in thousands):
Current 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):
Previous 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;
Current wording
•the scope, rate of progress and expense of our clinical trials as well as any additional, clinical trials and other research and development activities;
Previous 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.
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
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.
Current 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.
Previous 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.
Current 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.
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, 2025.
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 six months ended June 30, 2025.
Previous 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.
Current 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.
Previous 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.
Current 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.
Previous 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.
Current 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.
Previous wording
On February 27, 2024, the Company closed a private placement financing of up to $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.
Current wording
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.
Previous wording
We are evaluating several financing strategies to increase our cash runway, 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. 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.
Previous 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.
Current 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.
Previous wording
There were no cash flows from investing activities for the three months ended March 31, 2025 and 2024.
Current wording
There were no cash flows from investing activities for the six months ended June 30, 2025 and 2024.
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. There were no cash flows from financing activities for the three months ended March 31, 2025
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. Cash flows from financing activities for the six months ended June 30, 2025 were immaterial.
Previous 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;
Current wording
•the progress, costs, results and timing of our trials to evaluate cadisegliatinas a potential adjunctive therapy for the treatment of type 1 diabetes;
Previous wording
See discussion of recent accounting pronouncements in Note 2, “Summary of Significant Accounting Policies”, to the Condensed Consolidated Financial Statements in this Form 10-Q.
Current wording
See discussion of recent accounting pronouncements in Note 2, “Summary of Significant Accounting Policies”, to the Unaudited Condensed Consolidated Financial Statements in this Form 10-Q.
Rearranged current paragraphs (5)
Current report — wording carried from elsewhere
There was no revenue for the three months ended June 30, 2025 and 2024.
Current report — wording carried from elsewhere
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 report — wording carried from elsewhere
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 report — wording carried from elsewhere
The following table sets forth certain information concerning our results of operations for the periods shown:
Current report — wording carried from 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.