[vTv Therapeutics Announces 2025 First Quarter Financial Results and Provides Corporate Update](index=1&type=section&id=vTv%20Therapeutics%20Announces%202025%20First%20Quarter%20Financial%20Results%20and%20Provides%20Corporate%20Update) [Recent Company Highlights](index=1&type=section&id=Recent%20Company%20Highlights) vTv Therapeutics reinitiated screening for its CATT1 Phase 3 trial of cadisegliatin for Type 1 Diabetes and amended the protocol to shorten the study duration, aiming for topline data in 2H 2026 - Screening has been reinitiated in the Company's CATT1 Phase 3 trial evaluating cadisegliatin for type 1 diabetes (T1D), with topline data expected in the **second half of 2026**[1](index=1&type=chunk)[3](index=3&type=chunk)[5](index=5&type=chunk) - A protocol amendment for the CATT1 Phase 3 trial reduced the overall study duration from **12 to 6 months**, expediting time to topline data without impacting key endpoints, and will now provide continuous glucose monitors (CGM) to participants[3](index=3&type=chunk)[5](index=5&type=chunk) [First Quarter 2025 Financial Results Overview](index=1&type=section&id=First%20Quarter%202025%20Financial%20Results) The company reported a decrease in cash position, a slight increase in R&D expenses, a decrease in G&A expenses, and a net loss of $5.1 million for Q1 2025 Cash Position (in millions) | Metric | March 31, 2025 | December 31, 2024 | | :----- | :------------- | :---------------- | | Cash | $31.1 million | $36.7 million | Key Expenses (in millions) | Expense Type | Q1 2025 | Q1 2024 | Change (YoY) | | :----------- | :------ | :------ | :----------- | | R&D Expenses | $2.8 million | $2.6 million | +$0.2 million | | G&A Expenses | $3.7 million | $4.0 million | -$0.3 million | - The increase in R&D expenses reflects higher indirect costs and other project-related expenses, partially offset by lower spending on cadisegliatin and other projects[5](index=5&type=chunk) - The decrease in G&A expenses was primarily due to decreases in payroll costs, legal expense, and other operating costs, partially offset by an increase in share-based expense[5](index=5&type=chunk)[6](index=6&type=chunk) Net Loss and EPS (in millions, except per share data) | Metric | Q1 2025 | Q1 2024 | | :----- | :------ | :------ | | Net Loss | $5.1 million | $4.9 million | | EPS (basic) | $(0.77) | $(1.17) | [Condensed Consolidated Balance Sheets](index=3&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) As of March 31, 2025, total assets decreased to $32.0 million from $38.3 million at December 31, 2024, primarily driven by a reduction in cash and cash equivalents. Total liabilities also decreased, while total stockholders' equity saw a reduction Condensed Consolidated Balance Sheets Highlights (in thousands) | Metric | March 31, 2025 (Unaudited) | December 31, 2024 | | :-------------------------------- | :------------------------- | :---------------- | | Cash and cash equivalents | $31,059 | $36,746 | | Total current assets | $31,916 | $38,113 | | Total assets | $32,027 | $38,266 | | Total current liabilities | $4,316 | $5,196 | | Total liabilities | $23,130 | $23,965 | | Total stockholders' equity | $8,897 | $14,301 | [Condensed Consolidated Statements of Operations](index=4&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) For the three months ended March 31, 2025, the company reported no revenue, an operating loss of $6.5 million, and a net loss attributable to vTv Therapeutics Inc. of $5.1 million, or $(0.77) per basic and diluted share Condensed Consolidated Statements of Operations Highlights (in thousands, except per share data) | Metric | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :------------------------------------------ | :-------------------------------- | :-------------------------------- | | Revenue | $0 | $1,000 | | Research and development expenses | $2,830 | $2,649 | | General and administrative expenses | $3,673 | $3,978 | | Total operating expenses | $6,503 | $6,627 | | Operating loss | $(6,503) | $(5,627) | | Net loss attributable to vTv Therapeutics Inc. | $(5,092) | $(4,865) | | Net loss per share (basic and diluted) | $(0.77) | $(1.17) | | Weighted average shares outstanding | 6,582,844 | 4,141,492 | [About Cadisegliatin](index=4&type=section&id=About%20Cadisegliatin) Cadisegliatin (TTP399) is a novel, oral, liver-selective glucokinase activator being investigated as a potential first-in-class oral adjunctive treatment to insulin for type 1 diabetes (T1D), aiming to improve glycemic control - Cadisegliatin (TTP399) is a novel, oral small molecule, liver selective glucokinase activator[12](index=12&type=chunk) - It is being investigated as a potential first-in-class oral adjunctive treatment to insulin for type 1 diabetes (T1D)[12](index=12&type=chunk) - Nonclinical studies showed cadisegliatin increased glucokinase activity independently from insulin, supporting improved glycemic control through hepatic glucose uptake and glycogen storage[12](index=12&type=chunk) [About vTv Therapeutics](index=4&type=section&id=About%20vTv%20Therapeutics) vTv Therapeutics Inc. is a late-stage biopharmaceutical company focused on developing novel oral, small molecule drug candidates for chronic diseases, with cadisegliatin for T1D as its lead clinical pipeline asset - vTv Therapeutics Inc. is a late-stage biopharmaceutical company[14](index=14&type=chunk) - The company focuses on developing novel oral, small molecule drug candidates intended to help treat millions with chronic diseases[14](index=14&type=chunk) - Cadisegliatin, a potential first-in-class oral adjunctive therapy to insulin for type 1 diabetes, leads vTv's clinical pipeline[14](index=14&type=chunk) [Forward-Looking Statement](index=4&type=section&id=Forward-Looking%20Statement) The release contains forward-looking statements subject to risks and uncertainties, including those described in SEC filings, and the company undertakes no obligation to update them - This release contains forward-looking statements, identifiable by specific terminology, which involve risks and uncertainties[15](index=15&type=chunk) - Important factors, including those described in the company's Annual Report on Form 10-K and other SEC filings, could cause actual results to differ materially from expectations[15](index=15&type=chunk)[16](index=16&type=chunk) - The company undertakes no obligation to update or review publicly any forward-looking statements, except as required by law[16](index=16&type=chunk) [Investor and Media Contact](index=6&type=section&id=Investor%20Contact) Contact information for investor relations and media inquiries is provided - Investor Contact: Sandya von der Weid, LifeSci Advisors, LLC, svonderweid@lifesciadvisors.com[17](index=17&type=chunk) - Media Contact: Caren Begun, TellMed Strategies, 201-396-8551, caren.begun@tmstrat.com[17](index=17&type=chunk)

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 ____________________________ FORM 10-Q _____________________________ (Mark One) x QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2025 Or o TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission file number: 001-37524 _____________________________ vTv Therapeuti ...

Ongoing screening in CATT1 Phase 3 trial evaluating cadisegliatin in patients with type 1 diabetes (T1D) Topline Phase 3 data for cadisegliatin expected in 2H 2026 HIGH POINT, N.C., May 15, 2025 (GLOBE NEWSWIRE) -- vTv Therapeutics Inc. (Nasdaq: VTVT), a clinical stage biopharmaceutical company focused on the development of cadisegliatin, a potential first-in-class oral adjunctive therapy to insulin being investigated for the treatment of type 1 diabetes (T1D), today reported financial results for the first ...

Topline CATT1 Phase 3 data is expected in 2H 2026 Protocol amendment shortens trial duration from 12 to 6 months, expediting time to topline data HIGH POINT, N.C., May 15, 2025 (GLOBE NEWSWIRE) -- vTv Therapeutics Inc. (Nasdaq: VTVT), a late-stage biopharmaceutical company with an innovative clinical portfolio of small molecules and lead program in diabetes, today announced that screening has been reinitiated in the Company’s CATT1 Phase 3 trial investigating cadisegliatin as an adjunctive treatment of type ...

Core Insights - vTv Therapeutics has lifted the clinical hold on its cadisegliatin program for type 1 diabetes, allowing the Phase 3 CATT1 trial to resume in Q2 2025 [1][5] - The company has appointed Martin Lafontaine as Chief Commercial Officer to enhance its commercial strategy for cadisegliatin [2][5] Recent Developments - The FDA lifted the clinical hold on March 14, 2025, enabling the company to amend the CATT1 trial protocol, reducing its duration from 12 months to 6 months without affecting key endpoints [5] - Martin Lafontaine brings over 27 years of experience in the pharmaceutical and medical device industry, particularly in diabetes, which is expected to strengthen the company's market position [2][5] Financial Results - As of December 31, 2024, vTv Therapeutics reported a cash position of $36.7 million, a significant increase from $9.4 million a year earlier, primarily due to private placement financing [5] - Research and Development (R&D) expenses for Q4 2024 were $2.2 million, slightly up from $2.1 million in Q4 2023, while full-year R&D expenses decreased to $11.5 million from $13.6 million in 2023 [6][10] - General and Administrative (G&A) expenses for Q4 2024 were $2.7 million, compared to $2.6 million in Q4 2023, with full-year G&A expenses increasing to $13.7 million from $11.9 million in 2023 [6][10] Operational Metrics - The net loss attributable to vTv shareholders for Q4 2024 was $3.6 million, or $0.55 per share, compared to a net loss of $3.5 million, or $1.67 per share, in Q4 2023 [10][14] - For the full year 2024, the net loss attributable to vTv shareholders was $18.5 million, or $3.20 per share, down from a net loss of $20.3 million, or $9.71 per share, in 2023 [10][14]

Revenue and Financial Performance - Revenue for the year ended December 31, 2024 was $1.0 million, an increase from no revenue in 2023[356]. - The company reported a net loss attributable to vTv Therapeutics Inc. of $18.5 million for the year ended December 31, 2024, an improvement from a net loss of $20.3 million in 2023[355]. - Interest income for the year ended December 31, 2024 was $1.6 million, up from $0.5 million in 2023[359]. - For the year ended December 31, 2024, net cash used in operating activities increased by $6.2 million to $(25.3) million compared to $(19.1) million in 2023[367]. - The company has not generated any revenue from drug product sales and anticipates significant future funding requirements for ongoing development activities[370]. Expenses - Research and development expenses decreased by approximately $2.0 million, or 15.1%, from $13.6 million in 2023 to $11.5 million in 2024[357]. - General and administrative expenses increased by approximately $1.7 million, or 14.6%, from $11.9 million in 2023 to $13.7 million in 2024[358]. - Share-based compensation expenses are based on the fair value of awards at grant date, with estimates of forfeitures based on historical turnover rates[392]. Financing Activities - The company closed a private placement financing of up to $51.0 million on February 27, 2024, with an option for investors to purchase an additional $30.0 million of common stock[362]. - The company entered into a sales agreement with TD Cowen to offer up to $50.0 million in Class A common stock, with $2.5 million already raised from the sale of 179,400 shares[365]. - Financing activities in 2024 generated $52.6 million, primarily from the sale of Class A common stock and pre-funded warrants, compared to $12.0 million in 2023[369]. - The company plans to evaluate several financing strategies, including direct equity investments and potential licensing of other programs, to meet future funding requirements[363]. - The company plans to finance operations through cash and cash equivalents, equity offerings, and potential licensing arrangements[371]. Future Outlook and Risks - The successful development of drug candidates remains uncertain, with potential delays and additional costs impacting timelines[348]. - Future capital requirements will depend on the progress and costs associated with clinical trials for cadisegliatin, as well as FDA approval timelines[372]. - The company expects to incur significant commercialization expenses if regulatory approval is obtained for drug candidates[370]. - The company is seeking additional partnering opportunities for its drug candidates to provide cash for ongoing clinical trials[364]. Balance Sheet and Cash Position - As of December 31, 2024, the company had an accumulated deficit of $299.7 million and cash and cash equivalents of $36.7 million[361]. - As of December 31, 2024, there are no off-balance sheet arrangements[376]. - The company reported no cash flows from investing activities in 2024, while 2023 had net cash provided of $4.4 million from the sale of investments[368].

Financial Position - vTv Therapeutics reported a cash position of $36.7 million as of December 31, 2024, compared to $9.4 million as of December 31, 2023, reflecting a significant increase due to private placement financing[6] - Interest income for the year ended December 31, 2024, was $1.6 million, up from $0.5 million in 2023, reflecting improved financial management[6] Research and Development - Research and Development (R&D) expenses for Q4 2024 were $2.2 million, slightly up from $2.1 million in Q4 2023, while full-year R&D expenses decreased to $11.5 million from $13.6 million in 2023[6] - The FDA lifted the clinical hold on the cadisegliatin program on March 14, 2025, allowing the CATT1 Phase 3 trial to resume in Q2 2025[3] - The CATT1 Phase 3 trial protocol will be amended to reduce the trial duration from 12 months to 6 months, expediting the timeline for topline data[2] Operating Expenses - General and Administrative (G&A) expenses for Q4 2024 were $2.7 million, compared to $2.6 million in Q4 2023, with full-year G&A expenses increasing to $13.7 million from $11.9 million in 2023[6] - Total operating expenses for Q4 2024 were $4.9 million, compared to $4.7 million in Q4 2023, while full-year operating expenses were $25.2 million, slightly down from $25.5 million in 2023[10] Net Loss - The net loss attributable to vTv shareholders for Q4 2024 was $3.6 million, or $0.55 per basic share, compared to a net loss of $3.5 million, or $1.67 per basic share, in Q4 2023[6] - For the full year 2024, the net loss attributable to vTv shareholders was $18.5 million, or $3.20 per basic share, down from a net loss of $20.3 million, or $9.71 per basic share, in 2023[6] Leadership Changes - Martin Lafontaine was appointed as Chief Commercial Officer to enhance commercial leadership and support the cadisegliatin program[3]

Core Viewpoint - The FDA has lifted the clinical hold on vTv Therapeutics Inc.'s cadisegliatin clinical program, allowing the company to resume its Phase 3 trial for type 1 diabetes [1][4]. Group 1: Clinical Trial Updates - vTv Therapeutics plans to submit a protocol amendment to shorten the CATT1 trial duration from 12 months to 6 months, facilitating quicker topline data collection and the initiation of larger pivotal studies for future NDA submissions [2][4]. - The primary endpoint of assessing level 2 and 3 hypoglycemia rates at 6 months will remain unchanged despite the trial duration reduction [3]. - The clinical hold was previously imposed due to unresolved chromatographic signals in an ADME study, which the FDA required to be characterized through an in vitro study before resuming the program [6]. Group 2: Market Reaction - Following the FDA's announcement, vTv Therapeutics' stock price increased by 66.70%, reaching $24.76 [6]. Group 3: Product Potential - Cadisegliatin is positioned to potentially become the first oral adjunctive therapy to insulin for type 1 diabetes, with ongoing evaluations focused on its effects on glycemic control and hypoglycemia incidence compared to insulin alone [5].

Core Viewpoint - vTv Therapeutics has received FDA approval to lift the clinical hold on its cadisegliatin program, allowing the resumption of the CATT1 Phase 3 trial for type 1 diabetes, with a protocol amendment to shorten the trial duration from 12 months to 6 months [1][3][2] Group 1: Clinical Trial Updates - The CATT1 Phase 3 trial will now be conducted over 6 months instead of the original 12 months, expediting the process for larger pivotal studies necessary for future New Drug Application (NDA) submission [2][3] - The primary endpoint of assessing level 2 and 3 hypoglycemia rates at 6 months remains unchanged, while the additional 6-month period for safety data collection will be omitted [2][3] Group 2: Cadisegliatin Overview - Cadisegliatin (TTP399) is a novel oral small molecule that acts as a liver-selective glucokinase activator, being investigated as a potential first-in-class oral adjunctive treatment to insulin for type 1 diabetes [4][6] - In nonclinical studies, cadisegliatin has shown the ability to increase glucokinase activity independently from insulin, suggesting potential improvements in glycemic control through enhanced hepatic glucose uptake and glycogen storage [4] Group 3: Company Background - vTv Therapeutics Inc. is a late-stage biopharmaceutical company focused on developing novel oral, small molecule drug candidates aimed at treating chronic diseases, with cadisegliatin as the lead candidate in its clinical pipeline [6]

Financial Performance - Net loss attributable to vTv shareholders for Q3 2024 was $4.8 million, or $0.88 per basic share, an improvement from a net loss of $6.7 million, or $3.19 per basic share, in Q3 2023[2][4] - The company reported an operating loss of $6.5 million for Q3 2024, compared to an operating loss of $5.4 million in Q3 2023[4] - Other income for Q3 2024 was $0.2 million, compared to an expense of $3.3 million in Q3 2023, indicating a significant turnaround[2] Cash and Assets - Cash position increased to $41.6 million as of September 30, 2024, up from $9.4 million as of December 31, 2023[2] - Total current assets increased to $42.96 million as of September 30, 2024, compared to $10.66 million as of December 31, 2023[3] - Total liabilities decreased to $25.25 million as of September 30, 2024, down from $29.57 million as of December 31, 2023[3] Expenses - Research and Development (R&D) expenses for Q3 2024 were $3.2 million, compared to $2.8 million in Q3 2023, reflecting a 14.3% increase[2] - General and Administrative (G&A) expenses rose to $3.3 million in Q3 2024 from $2.5 million in Q3 2023, marking a 32% increase[2] Product Development - The company is progressing with the cadisegliatin program, aimed at improving glycemic control in type 1 diabetes patients, and is in discussions with the FDA regarding a clinical hold[1] - vTv Therapeutics is focused on developing oral, small molecule drug candidates, with cadisegliatin as a lead program for type 1 diabetes[5]