Revenue and Financial Performance - Revenue for the three months ended March 31, 2025, was $0, a decrease of $1.0 million compared to $1.0 million in the same period of 2024[112]. - Interest income for the three months ended March 31, 2025, was $0.3 million, an increase from $0.1 million in the same period of 2024[116]. - The total operating expenses for the three months ended March 31, 2025, were $6.5 million, a slight decrease from $6.6 million in 2024[112]. - For the three months ended March 31, 2025, net cash used in operating activities was $5.687 million, a decrease of $1.6 million compared to the same period in 2024[122][123]. - Net cash provided by financing activities for the three months ended March 31, 2024, was $51.0 million, driven by sales of Class A common stock and proceeds from pre-funded warrants[125]. Expenses - Research and development expenses increased by $0.2 million, or 6.8%, to $2.8 million for the three months ended March 31, 2025, primarily due to an increase in indirect expenses[114]. - General and administrative expenses decreased by $0.3 million, or 7.7%, to $3.7 million for the three months ended March 31, 2025, driven by reductions in payroll and legal expenses[115]. - The company anticipates needing substantial additional funding for ongoing operations and commercialization expenses[126][129]. Cash Position and Funding - As of March 31, 2025, the company had cash and cash equivalents of $31.1 million[118]. - The company plans to finance operations through cash and cash equivalents, including future funding activities, and is evaluating financing strategies for clinical trials[127]. - Future capital requirements will depend on various factors, including the progress and costs of clinical trials for cadisegliatin, and the ability to maintain control over costs[128]. - The company 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[121]. - The company may face dilution of common stockholders' interests if additional capital is raised through equity or convertible debt securities[130]. Regulatory and Development Updates - The FDA granted Breakthrough Therapy designation for cadisegliatin in 2021, supported by positive results from the Phase 2 SimpliciT-1 Study, which showed a 40% reduction in severe hypoglycemia[98]. - The company plans to initiate two international registrational studies for cadisegliatin in type 1 diabetes, expected to start in 2027[100]. - The company has not generated any revenue from drug product sales to date and does not expect to until regulatory approval is obtained[126]. Financial Risks and Considerations - The company had an accumulated deficit of $304.8 million as of March 31, 2025, and anticipates continued losses and negative cash flow from operations[118]. - As of March 31, 2025, the company did not have any off-balance sheet arrangements[131]. - The company has no material interest rate or foreign currency exposure[136][138].

Core Insights - vTv Therapeutics is advancing its cadisegliatin program, which is being evaluated as a potential first-in-class oral adjunct therapy for type 1 diabetes (T1D) [2][3] - The company has reinitiated screening in its Phase 3 CATT1 trial and expects topline data in the second half of 2026 following a protocol amendment that shortens the trial duration from 12 to 6 months [3][6] Company Developments - Financial results for Q1 2025 show a net loss of $5.1 million, or $0.77 per share, compared to a net loss of $4.9 million, or $1.17 per share, in Q1 2024 [6][9] - The cash position as of March 31, 2025, was $31.1 million, down from $36.7 million as of December 31, 2024 [6][7] - Research and Development (R&D) expenses increased to $2.8 million in Q1 2025 from $2.6 million in Q1 2024, reflecting higher indirect costs [6][9] - General and Administrative (G&A) expenses decreased to $3.7 million in Q1 2025 from $4.0 million in Q1 2024, primarily due to lower payroll and legal expenses [6][9] Financial Overview - Total operating expenses for Q1 2025 were $6.5 million, slightly down from $6.6 million in Q1 2024 [9] - The company reported no revenue for Q1 2025, compared to $1 million in Q1 2024 [9] - Total assets as of March 31, 2025, were $32.0 million, down from $38.3 million as of December 31, 2024 [7][8] Product Information - Cadisegliatin (TTP399) is a novel oral small molecule being investigated for its potential to improve glycemic control in T1D patients by selectively activating glucokinase in the liver [10][12]

Core Viewpoint - vTv Therapeutics has resumed its CATT1 Phase 3 trial for cadisegliatin, an oral treatment for type 1 diabetes, with topline data expected in the second half of 2026 [2][3]. Group 1: Trial Details - The CATT1 Phase 3 trial duration has been shortened from 12 months to 6 months through a protocol amendment, expediting the timeline for topline data without affecting key study endpoints [3][4]. - The trial will enroll approximately 150 patients aged 18 and older at 20-25 sites in the U.S., comparing two doses of cadisegliatin against a placebo [4]. - Continuous glucose monitors will be provided to all participants to assess the primary efficacy endpoint, which focuses on the incidence of level 2 and level 3 hypoglycemic events [3][4]. Group 2: Product Information - Cadisegliatin (TTP399) is a novel, liver-selective glucokinase activator being investigated as a potential first-in-class oral adjunctive treatment for type 1 diabetes [5]. - Non-clinical studies indicate that cadisegliatin enhances glucokinase activity independently of insulin, suggesting potential improvements in glycemic control [5]. Group 3: Company Overview - vTv Therapeutics Inc. is a late-stage biopharmaceutical company focused on developing oral, small molecule drug candidates, with cadisegliatin as its lead program for type 1 diabetes [7].

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]

Financial Position - vTv Therapeutics reported a cash position of $45.5 million as of June 30, 2024, up from $9.4 million at the end of 2023, attributed to private placement financing[4] - The net loss attributable to vTv shareholders for Q2 2024 was $5.2 million, or $0.81 per share, compared to a net loss of $5.6 million, or $2.69 per share, in the same period last year[6] - Total operating expenses for Q2 2024 were $7.2 million, down from $8.0 million in Q2 2023, indicating a decrease of approximately 10%[9] Research and Development - Research and Development (R&D) expenses decreased to $3.4 million in Q2 2024 from $4.7 million in Q2 2023, a reduction of approximately 28%[4] - The first patient was screened in the pivotal trial for cadisegliatin for type 1 diabetes (T1D), although the FDA placed a clinical hold on the program due to unresolved issues in a recent study[2] - vTv Therapeutics has dosed over 500 subjects in cadisegliatin studies, including 300 patients with type 1 and type 2 diabetes, demonstrating its potential for improved glycemic control[1] - The company is actively working with the FDA to resolve the clinical hold on cadisegliatin and aims to resume the study as soon as possible[2] General and Administrative Expenses - General and Administrative (G&A) expenses increased to $3.7 million in Q2 2024 from $3.3 million in Q2 2023, reflecting a rise of about 12%[5] Licensing and Designation - vTv Therapeutics expanded its licensing agreement with Newsoara Biopharma for the PDE4 inhibitor HPP737 to a global license, contingent upon a $20 million upfront fee and potential milestones totaling up to $76 million[2] - Azeliragon received Orphan Drug Designation from the FDA for pancreatic cancer and glioblastoma, with potential revenue sharing of 20-40% from licensing income[3]