Core Viewpoint - vTv Therapeutics Inc. has received a Notice of Allowance from the USPTO for a patent application related to cadisegliatin, which strengthens the protection of this potential first-in-class oral adjunctive therapy for type 1 diabetes [1][2] Company Overview - vTv Therapeutics is a late-stage biopharmaceutical company focused on developing oral, small molecule drug candidates for diabetes and other chronic diseases [4] - The company's lead asset, cadisegliatin, is currently in a Phase 3 trial and has been granted Breakthrough Therapy designation by the FDA [2][4] Product Details - Cadisegliatin (TTP399) is a liver-selective glucokinase activator being investigated as a potential first-in-class oral adjunctive treatment for type 1 diabetes [2] - In non-clinical studies, cadisegliatin has shown the ability to increase glucokinase activity independently from insulin, which may improve glycemic control [2] Patent Information - The patent term for the compositions of matter related to cadisegliatin runs through 2041, providing long-term protection for the innovation [1][2]

Core Insights - vTv Therapeutics Inc. has initiated the CATT1 Phase 3 trial for cadisegliatin, an oral glucokinase activator for type 1 diabetes, with topline results expected in the second half of 2026 [1][2] - The trial aims to enroll approximately 150 participants across 25 sites in the U.S., evaluating the efficacy and safety of cadisegliatin compared to placebo [2][4] - Cadisegliatin has received Breakthrough Therapy designation from the FDA and has shown good tolerability in over 500 subjects [1][2] Company Overview - vTv Therapeutics is a late-stage biopharmaceutical company focused on developing oral small molecule drug candidates for diabetes and other chronic diseases [6] - The company's lead program, cadisegliatin, is being investigated as a potential first-in-class oral adjunctive treatment for type 1 diabetes [6] Industry Context - There is a significant unmet need for therapeutic advances in type 1 diabetes, as current medical devices have not been complemented by effective oral adjunct therapies [2][3] - The introduction of glucokinase activators like cadisegliatin could potentially improve glycemic control while reducing the risks of hypoglycemia and diabetic ketoacidosis [3][4]

Company Overview - vTv Therapeutics Inc. is a clinical stage biopharmaceutical company focused on developing cadisegliatin, a potential first-in-class oral adjunctive therapy to insulin for treating type 1 diabetes (T1D) [1][3] - The company is in the late stages of developing oral, small molecule drug candidates aimed at treating diabetes and other chronic diseases [3] Upcoming Event - vTv Therapeutics management will participate in the H.C. Wainwright "HCW@Home" Series on June 12, 2025, at 10:00 AM ET [1][2] - The event will be a fireside chat moderated by Emily Bodnar, Director at H.C. Wainwright [2] Clinical Development - Cadisegliatin is currently in a Phase 3 trial, being investigated as a potential oral glucokinase activator for type 1 diabetes [3] - The company is exploring multiple molecules for various indications related to chronic diseases [3]

Core Viewpoint - vTv Therapeutics Inc. has appointed Dr. Michael Tung as Executive Vice President and Chief Financial Officer, which is a strategic move as the company reinitiates its CATT1 Phase 3 trial for cadisegliatin, a potential treatment for type 1 diabetes [1][2] Company Overview - vTv Therapeutics Inc. is a late-stage biopharmaceutical company focused on developing oral small molecule drug candidates for diabetes and other chronic diseases [3] - The company's clinical pipeline is led by cadisegliatin, currently in a Phase 3 trial, which is being investigated as a potential first-in-class oral glucokinase activator for type 1 diabetes [3][4] Appointment of Dr. Michael Tung - Dr. Tung brings over 20 years of experience in finance, corporate strategy, investor relations, and business development within the biopharmaceutical industry [2] - His previous roles include Chief Financial Officer at AdvanCell Pty Limited and senior positions at FibroGen Inc. and Aclaris Therapeutics [2] - Dr. Tung holds degrees in economics and biology from The George Washington University and an M.D./M.B.A. from Tufts University School of Medicine [2] Cadisegliatin Details - Cadisegliatin (TTP399) is a novel oral small molecule that selectively activates glucokinase in the liver, aimed at improving glycemic control in type 1 diabetes [4] - Non-clinical studies indicate that cadisegliatin increases glucokinase activity independently from insulin, supporting its clinical investigation [4]

[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)

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].