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 Viewpoint - vTv Therapeutics (VTVT) has shown a significant price increase of 41.4% over the past four weeks, with a mean price target of $37 indicating a potential upside of 25.2% from the current price of $29.56 [1] Price Targets and Analyst Consensus - The average price target for VTVT ranges from a low of $35.00 to a high of $40.00, with a standard deviation of $2.65, suggesting a relatively tight clustering of estimates [2] - The lowest estimate indicates an 18.4% increase, while the highest suggests a 35.3% upside [2] - A low standard deviation indicates a high degree of agreement among analysts regarding the stock's price movement [9] Earnings Estimates and Market Sentiment - Analysts are optimistic about VTVT's earnings prospects, as indicated by a positive trend in earnings estimate revisions, which has shown a strong correlation with near-term stock price movements [11] - The Zacks Consensus Estimate for the current year has increased by 9.2% over the past month, with no negative revisions reported [12] - VTVT holds a Zacks Rank 2 (Buy), placing it in the top 20% of over 4,000 ranked stocks based on earnings estimates [13] Caution on Price Targets - While price targets are commonly referenced, they can often mislead investors, and reliance solely on them may not yield favorable returns [3][10] - Analysts may set overly optimistic price targets due to business incentives, which can inflate expectations [8]

Core Viewpoint - vTv Therapeutics (VTVT) has received an upgrade to a Zacks Rank 2 (Buy), indicating a positive outlook based on rising earnings estimates, which significantly influence stock prices [1][3]. Earnings Estimates and Stock Price Impact - The Zacks rating system emphasizes the importance of changing earnings estimates, which are closely correlated with near-term stock price movements [4][6]. - Rising earnings estimates for vTv Therapeutics suggest an improvement in the company's underlying business, likely leading to an increase in stock price [5][10]. Zacks Rating System - The Zacks Rank system classifies stocks into five groups based on earnings estimates, with a strong historical performance, particularly for Zacks Rank 1 stocks, which have averaged a +25% annual return since 1988 [7][9]. - The upgrade of vTv Therapeutics to a Zacks Rank 2 places it in the top 20% of Zacks-covered stocks, indicating a strong potential for market-beating returns in the near term [10]. Earnings Estimate Revisions - For the fiscal year ending December 2025, vTv Therapeutics is expected to earn -$3.35 per share, unchanged from the previous year, but the Zacks Consensus Estimate has increased by 6.2% over the past three months [8].

Financial Performance - The company has not generated any revenue from drug sales to date, relying primarily on milestone payments and research fees [100]. - Revenue for the nine months ended September 30, 2025, was $0, a decrease of $1.0 million compared to $1.0 million in 2024 [118]. - The net loss attributable to vTv Therapeutics Inc. for the three months ended September 30, 2025, was $8.7 million, compared to a net loss of $4.8 million in 2024 [111]. - Net loss attributable to vTv Therapeutics Inc. increased by $5.0 million, from $14.8 million in 2024 to $19.8 million in 2025 [117]. Expenses - Research and development expenses for the three months ended September 30, 2025, were $7.0 million, an increase of $3.8 million or 117.7% compared to $3.2 million in 2024, driven by increased spending on cadisegliatin and other projects [113]. - General and administrative expenses increased by $0.4 million or 12.1% to $3.7 million for the three months ended September 30, 2025, compared to $3.3 million in 2024 [114]. - Total operating expenses for the three months ended September 30, 2025, were $10.7 million, an increase of $4.2 million compared to $6.5 million in 2024 [111]. - Research and development expenses increased by $4.6 million, or 49.8%, from $9.3 million in 2024 to $14.0 million in 2025, primarily due to increased indirect costs and spending on cadisegliatin [119]. - General and administrative expenses remained flat at $11.0 million for both periods, with a slight decrease of $0.0 million or 0.1% [120]. Cash Flow and Financing - As of September 30, 2025, the company had cash and cash equivalents of $98.5 million, with an accumulated deficit of $319.6 million [124]. - Net cash used in operating activities decreased by $4.5 million, from $20.5 million in 2024 to $16.0 million in 2025 [130]. - Net cash provided by financing activities increased to $77.8 million in 2025, compared to $52.6 million in 2024, driven by a private placement [132]. - The company plans to finance operations through cash reserves and future funding activities, including potential licensing and monetization of programs [134]. - The company has sold 179,400 shares under the TD Cowen ATM Offering for net proceeds of $2.5 million, leaving $47.5 million available to be sold [128]. Research and Development - The company expects to have top-line data from the CATT1 study in the second half of 2026, following a protocol amendment to shorten the study duration from 12 months to 6 months [96]. - The FDA granted Breakthrough Therapy designation for cadisegliatin in 2021, supporting its development as an adjunctive therapy to insulin for type 1 diabetes [95]. - The company initiated a food effect study in June 2025 to assess the impact of food on the pharmacokinetics of cadisegliatin, with data currently being analyzed [97]. - A Phase 2 trial in the Middle East for cadisegliatin in type 2 diabetes patients is expected to begin in the fourth quarter of 2025, involving 300 patients [98]. Financial Risks - The company has no material interest rate exposure, indicating a stable financial position regarding interest rates [144]. - Market risk exposure is limited to cash and cash equivalents with maturities of one year or less, focusing on capital preservation and liquidity needs [145]. - The investment strategy aims to maximize income from investments without assuming significant risk, maintaining cash with high credit quality institutions [145]. - There is no material foreign currency exposure, suggesting minimal risk from currency fluctuations [146].

Financial Performance - vTv Therapeutics reported a net loss of $8.7 million or $1.08 per basic share for Q3 2025, compared to a net loss of $4.8 million or $0.88 per basic share in Q3 2024[6]. - Total operating expenses for Q3 2025 were $10.7 million, compared to $6.5 million in Q3 2024[10]. - vTv Therapeutics' accumulated deficit reached $319.55 million as of September 30, 2025, compared to $299.72 million at the end of 2024[8]. Cash Position - The company's cash position increased to $98.5 million as of September 30, 2025, up from $36.7 million at the end of 2024[5]. - The total liabilities increased to $28.95 million as of September 30, 2025, from $23.97 million at the end of 2024[8]. Research and Development - Research and development expenses rose to $7.0 million in Q3 2025, compared to $3.2 million in Q3 2024, reflecting increased spending on cadisegliatin and other projects[6]. - vTv Therapeutics successfully completed an $80 million private placement in September 2025 to fund the ongoing CATT1 Phase 3 trial[5]. - The first patient was randomized in the Phase 3 CATT1 trial for cadisegliatin in August 2025, with topline data expected in the second half of 2026[5]. - The company anticipates reporting topline results from the CATT1 trial in the second half of 2026[2]. Intellectual Property - The U.S. Patent and Trademark Office allowed claims for a new patent covering crystalline forms of cadisegliatin, with exclusivity expected until 2041[5].

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]

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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]