HIGH POINT, N.C., Dec. 18, 2025 (GLOBE NEWSWIRE) -- vTv Therapeutics Inc. (Nasdaq: VTVT), a late-stage biopharmaceutical company, today announced a Phase 2 clinical study protocol developed in collaboration with M42’s Insights Research Organization & Solutions (IROS), a leading United Arab Emirates (UAE)-based contract research organization, has been submitted to the Department of Health (DOH) Abu Dhabi. The study is designed to evaluate the safety and efficacy of cadisegliatin, a potential first-in-class o ...

Core Insights - vTv Therapeutics is advancing its cadisegliatin program, a potential first-in-class oral adjunctive therapy for type 1 diabetes, with topline Phase 3 CATT1 data expected in the second half of 2026 [1][2] - The company successfully completed an $80 million private placement to strengthen its balance sheet and support the ongoing Phase 3 trial [1][5] - A new U.S. patent covering crystalline salts and co-crystals of cadisegliatin has been issued, providing exclusivity until 2041 [1][5] Recent Company Highlights - The first patient was randomized in the Phase 3 CATT1 trial for cadisegliatin in August 2025 [5] - The patent allowance for cadisegliatin's crystalline salt form was granted by the U.S. Patent and Trademark Office [5] - The cash position as of September 30, 2025, was $98.5 million, a significant increase from $36.7 million as of December 31, 2024 [5][7] Third Quarter 2025 Financial Results - Research and Development (R&D) expenses increased to $7.0 million in Q3 2025 from $3.2 million in Q3 2024, reflecting higher spending on cadisegliatin and other projects [5][9] - General and Administrative (G&A) expenses rose to $3.7 million in Q3 2025 from $3.3 million in Q3 2024, primarily due to payroll and legal expenses [5][9] - The net loss attributable to vTv shareholders for Q3 2025 was $8.7 million, or $1.08 per basic share, compared to a net loss of $4.8 million, or $0.88 per basic share, in the same period last year [5][10]

Core Insights - vTv Therapeutics has appointed a distinguished Scientific Advisory Board (SAB) to guide the clinical development of cadisegliatin for type 1 diabetes, which is currently in Phase 3 trials [1][2][4] Company Overview - vTv Therapeutics is a late-stage biopharmaceutical company focused on developing oral, small molecule drug candidates for diabetes and other chronic diseases, with cadisegliatin as its lead candidate [7] Scientific Advisory Board - The SAB includes experts in endocrinology and diabetes research, such as Dr. John Buse, Dr. Alfonso Galderisi, Dr. Mark Evans, Dr. Chantal Mathieu, Dr. Alexander Fleming, and Dr. Klara Klein, who will provide strategic guidance on clinical trial planning and regulatory strategy [2][8] Cadisegliatin Details - 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 [5][6]

Core Insights - vTv Therapeutics Inc. is presenting new independent research on its investigational small molecules for type 1 diabetes (T1D) at the INNODIA Symposium during the EASD 61 Annual Meeting [1][2] - The company is focusing on TTP-RA, an oral RAGE antagonist, and cadisegliatin, a potential first-in-class oral glucokinase activator, both aimed at improving T1D treatment [3][4] Company Overview - vTv Therapeutics is a late-stage biopharmaceutical company dedicated to developing oral, small molecule drug candidates for diabetes and other chronic diseases [4] - The clinical pipeline is led by cadisegliatin, currently in a Phase 3 trial for T1D [4][5] Research and Development - Dr. Carmen Valcarce will present preclinical data on TTP-RA, highlighting its ability to restore glucose homeostasis and modulate immune responses [2][3] - The company is actively seeking strategic partnerships to advance the development of TTP-RA [2][4] Product Details - Cadisegliatin (TTP399) is being investigated as a potential first-in-class oral adjunctive treatment for T1D, showing increased glucokinase activity in non-clinical studies [5]

Core Insights - vTv Therapeutics Inc. is a late-stage biopharmaceutical company focused on developing cadisegliatin, a potential first-in-class oral adjunctive therapy to insulin for type 1 diabetes treatment [1][2] - The company will participate in two upcoming investor conferences in September 2025, including the H.C. Wainwright 27th Annual Global Investment Conference and the Morgan Stanley 23rd Annual Global Healthcare Conference [1][2] Company Overview - vTv Therapeutics specializes in oral, small molecule drug candidates aimed at treating diabetes and other chronic diseases [2] - The clinical pipeline is led by cadisegliatin, which is currently in a Phase 3 trial as a potential oral glucokinase activator for type 1 diabetes [2] - The company is also exploring multiple molecules across various indications for chronic diseases in collaboration with development partners [2]

Company Overview - vTv Therapeutics Inc. is a late-stage biopharmaceutical company focused on developing cadisegliatin, a potential first-in-class oral adjunctive therapy to insulin for the treatment of type 1 diabetes [1][2] - The company is also investigating multiple molecules across different indications for chronic diseases [2] Upcoming Investor Conferences - vTv Therapeutics will participate in the H.C. Wainwright 27th Annual Global Investment Conference on September 9, 2025, with a format of 1x1 investor meetings only [1] - The company will also be present at the Morgan Stanley 23rd Annual Global Healthcare Conference on the same day, featuring a fireside chat from 2:35 PM to 3:10 PM EST, along with 1x1 investor meetings [2] Clinical Pipeline - The clinical pipeline of vTv is led by cadisegliatin, which is currently in a Phase 3 trial for type 1 diabetes [2]

Core Viewpoint - vTv Therapeutics Inc. has announced an $80 million private placement financing to support the ongoing development of cadisegliatin, a potential first-in-class oral adjunctive therapy for type 1 diabetes, with topline data from the CATT1 Phase 3 trial expected in the second half of 2026 [1][4]. Financing Details - The PIPE financing involves existing and new investors, including Samsara BioCapital, the T1D Fund, Trails Edge Capital Partners, and Invus [2]. - The financing will consist of 682,018 shares of Class A Common Stock and pre-funded warrants to purchase 4,561,714 shares, with accompanying warrants for an aggregate of 5,243,732 shares [3]. - The purchase price for a unit of Class A Common Stock and accompanying warrant is $15.265, while the pre-funded warrant unit is priced at $15.255, with an exercise price of $22.71 per share for the accompanying warrants [3]. Product Development - The funding will facilitate the advancement of cadisegliatin through the CATT1 trial, which aims to evaluate its potential to reduce hypoglycemic events and improve glycemic control in individuals with type 1 diabetes [4]. - Cadisegliatin is a liver-selective glucokinase activator that has received Breakthrough Therapy designation from the U.S. FDA, indicating its potential significance in treating type 1 diabetes [8][9]. Company Overview - vTv Therapeutics is a late-stage biopharmaceutical company focused on developing oral small molecule drug candidates for diabetes and other chronic diseases, with cadisegliatin as its leading candidate currently in Phase 3 trials [10].

Core Viewpoint - vTv Therapeutics Inc. is advancing its late-stage biopharmaceutical candidate cadisegliatin, aimed at treating type 1 diabetes, with recent developments including the initiation of a Phase 3 trial and financial results indicating ongoing investment in research and development [2][3][5]. Recent Company Highlights - The first participant has been randomized in the CATT1 Phase 3 trial for cadisegliatin, with topline data expected in the second half of 2026 [6][7]. - The intellectual property portfolio for cadisegliatin has been expanded, with a patent application for crystalline forms allowed, extending the patent term through 2041 [7]. - Michael Tung has been appointed as Chief Financial Officer, bringing over 20 years of experience in financial management and strategic leadership [7]. Second Quarter 2025 Financial Results - As of June 30, 2025, the company's cash position was $25.9 million, down from $36.7 million at the end of 2024 [7]. - Research and Development (R&D) expenses increased to $4.1 million from $3.4 million in the same quarter of 2024, primarily due to higher payroll costs [7]. - General and Administrative (G&A) expenses decreased slightly to $3.6 million from $3.7 million year-over-year [7]. - The net loss attributable to vTv shareholders for the quarter was $6.0 million, or $0.92 per share, compared to a net loss of $5.2 million, or $0.81 per share, in the same period last year [8][12].

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]