Cadisegliatin

New research spotlights hypoglycemia-related burdens in adults with type 1 diabetes using automated insulin delivery systems HIGH POINT, N.C., Oct. 10, 2026 (GLOBE NEWSWIRE) -- vTv Therapeutics Inc. (Nasdaq: VTVT), a late-stage biopharmaceutical company advancing cadisegliatin, a novel oral investigational therapy for type 1 diabetes (T1D), today announced that Chief Medical Officer Thomas Strack, M.D., Ph.D., presented research spotlighting hypoglycemia-related burdens among adults with T1D using automated insulin delivery (AID) systems at the inaugural Breakthrough T1D Clinical & Research Congress (CRC 2026) in Philadelphia, PA. Cadisegliatin is a potential first-in-class, liver-selective glucokinase activator (GKA) being evaluated as an oral adjunctive therapy to insulin for the treatment of T1D. “ A Cumulative Population View of Hypoglycemia-Related Burdens in T1D Adults Using AID Systems," a quantitative online research initiative commissioned by vTv Therapeutics and conducted by dQ&A Market Research, Inc., examined the prevalence of clinically meaningful hypoglycemia-related burdens among 674 adults with T1D of whom 429 were using AID systems. Among adult AID system users, 24% reported experiencing frequent Level 2 hypoglycemia, defined as daily, almost daily, or a few moderate hypoglycemic events (7%, 49% strongly agreed that they often keep their blood glucose higher to avoid hypoglycemia or that they would target lower glucose levels if not for the risk of hypoglycemia. Respondents were then segmented using a mutually exclusive framework across the above four hypoglycemia-related burden dimensions. After accounting for overlap across segments and weighting for A1C, approximately 54% of adults with T1D using an AID system were estimated to experience at least one of the four dimensions of hypoglycemia-related burden. “These findings reinforce that, despite meaningful advances in insulin delivery technology, insulin has its limitations and hypoglycemia continues to shape daily glucose management for many people with type 1 diabetes,” said Paul Sekhri, Chairman, President, and Chief Executive Officer of vTv Therapeutics. “The fact that more than half of adults using AID systems still experience clinically meaningful hypoglycemia-related burdens underscores the need for additional treatment options that can work alongside insulin and existing technologies to help address this burden.” "Our mission at dQ&A is to serve as the voice of people living with diabetes. These findings highlight the challenges that many people with T1D continue to experience with hypoglycemia, including those using technologies such as AID,” said Richard Wood, Chief Executive Officer of dQ&A Market Research, Inc. “We are excited by the prospect of new therapies that could complement existing technologies and further alleviate this burden to give people greater confidence and freedom in their everyday lives.” About Cadisegliatin Cadisegliatin (TTP399) is a novel, oral small-molecule, glucokinase activator being investigated in the U.S. as a potential first-in-class adjunctive treatment for T1D. In nonclinical studies, cadisegliatin acted selectively on the liver and increased the activity of glucokinase independently of insulin. These studies support clinical investigation of whether cadisegliatin can improve glycemic control through hepatic glucose uptake and glycogen storage. Cadisegliatin has been granted Breakthrough Therapy designation by the U.S. Food and Drug Administration (FDA).  Cadisegliatin is under investigation, and its safety and efficacy have not been established. There is no guarantee that this product will receive health authority approval or become commercially available for the use being investigated.  About vTv Therapeutics vTv Therapeutics is a late-stage biopharmaceutical company focused on developing oral, small molecule drug candidates intended to help treat people living with diabetes and other chronic diseases. vTv’s clinical pipeline is led by cadisegliatin, a potential first-in-class oral glucokinase activator being investigated in a U.S. Phase 3 study for the treatment of T1D. vTv and its development partners are investigating multiple molecules across different indications for chronic diseases. Learn more at vtvtherapeutics.com or follow the company on LinkedIn . About dQ&A Market Research, Inc. Founded in 2009, dQ&A Market Research is a leading diabetes-focused research firm dedicated to understanding the real-world experiences of people living with diabetes and those who care for them. Through our proprietary panels of thousands of patients and caregivers across the United States, Canada, and Europe, we conduct ongoing surveys and in-depth qualitative and quantitative research that capture the evolving needs, preferences, and challenges of the diabetes community. Our team includes seasoned researchers, data scientists, and consultants, many with a personal connection to diabetes, focused on delivering impactful and unbiased insights to the diabetes industry, government organizations, and medical associations. For more information, please visit or email info@d-qa.com . Forward-Looking Statements This release contains forward-looking statements, which involve risks and uncertainties. These forward-looking statements can be identified by the use of forward-looking terminology, including the terms “anticipate,” “believe,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” “would” and, in each case, their negative or other variations or comparable terminology. All statements other than statements of historical facts contained in this release, including statements regarding the timing of our clinical trials, the anticipated effect of Phase 3 topline data on the Company, the benefits of cadisegliatin to people living with T1D, our strategy, future operations, future financial position, future revenue, projected costs, prospects, plans, objectives of management and expected market growth are forward-looking statements. These statements involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance, or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Important factors that could cause our results to vary from expectations include those described under the heading “Risk Factors” in our Annual Report on Form 10-K, subsequent Quarterly Reports on Form 10-Q and our other filings with the SEC. These forward-looking statements reflect our views with respect to future events as of the date of this release and are based on assumptions and subject to risks and uncertainties. Given these uncertainties, you should not place undue reliance on these forward-looking statements. These forward-looking statements represent our estimates and assumptions only as of the date of this release and, except as required by law, we undertake no obligation to update or review publicly any forward-looking statements, whether as a result of new information, future events or otherwise after the date of this release. We anticipate that subsequent events and developments will cause our views to change. Our forward-looking statements do not reflect the potential impact of any future acquisitions, mergers, dispositions, joint ventures, or investments we may undertake. We qualify all our forward-looking statements by these cautionary statements. Investor Contact John Fraunces LifeSci Advisors, LLC jfraunces@lifesciadvisors.com Media Contact Caren Begun TellMed Strategies 201-396-8551 caren.begun@tmstrat.com

Milestone supports partnering discussions for HPPD as the Company continues to prioritize its lead late-stage type 1 diabetes (T1D) program, cadisegliatin HIGH POINT, N.C., Oct. 07, 2026 (GLOBE NEWSWIRE) -- vTv Therapeutics Inc. (Nasdaq: VTVT), a late-stage biopharmaceutical company advancing cadisegliatin, a novel oral investigational therapy for type 1 diabetes (T1D), today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to HPPD, the Company’s oral, first-in-class Nrf2/Bach1 modulator. HPPD is being investigated as a treatment for sickle cell disease. “The FDA’s Orphan Drug Designation reinforces both the urgency of the unmet need in this devastating disease and the opportunity to bring forward potential new therapeutic approaches,” said Paul Sekhri, Chairman, President, and CEO of vTv Therapeutics. “Receiving this designation marks an important inflection point for this program and strengthens vTv’s ability to advance strategic partnering discussions for HPPD while continuing to develop cadisegliatin in T1D.” Preclinical studies conducted at Augusta University using the Townes sickle cell disease mouse model showed that HPPD was orally active and well tolerated, increased fetal hemoglobin, and reduced oxidative stress and red blood cell sickling. These findings support the continued development of HPPD in sickle cell disease. About Sickle Cell Disease Sickle cell disease is a lifelong, inherited blood disease characterized by chronic hemolytic anemia, recurrent vaso-occlusive pain crises, oxidative stress, progressive organ damage, and reduced quality of life. It affects approximately 100,000 people in the United States; more than 90% are non-Hispanic Black or African American, and an estimated 3-9% are Hispanic or Latino. i Although induction of fetal hemoglobin (HbF) remains a validated disease-modifying strategy and hydroxyurea is an important, approved HbF-inducing therapy, many patients continue to face inadequate response, tolerability challenges, or persistent complications. ii These ongoing gaps show the need for additional oral therapies with novel mechanisms of action that may help address the underlying biology of sickle cell disease. About HPPD HPPD (HPP8668) is an investigational, oral, first-in-class Nrf2/Bach1 modulator being developed by vTv Therapeutics for the treatment of sickle cell disease. Preclinical studies in the Townes sickle cell disease mouse model have shown that HPPD induces fetal hemoglobin (HbF) in a time- and dose-dependent manner, with effects comparable to or exceeding hydroxy urea, the current standard HbF-inducing therapy. In addition to HbF induction, HPPD showed reductions in oxidative stress and sickled red blood cells, supporting its potential as a disease-modifying oral therapy with a differentiated mechanism of action. HPPD is under investigation, and safety and efficacy have not been established. There is no guarantee that this product will receive health authority approval or become commercially available for the use being investigated. About Cadisegliatin Cadisegliatin (TTP399) is a novel, oral small-molecule, glucokinase activator being investigated in the U.S. as a potential first-in-class adjunctive treatment for T1D. In nonclinical studies, cadisegliatin acted selectively on the liver and increased the activity of glucokinase independently of insulin. These studies support clinical investigation of whether cadisegliatin can improve glycemic control through hepatic glucose uptake and glycogen storage. Cadisegliatin has been granted Breakthrough Therapy designation by the U.S. Food and Drug Administration (FDA). Cadisegliatin is under investigation, and its safety and efficacy have not been established. There is no guarantee that this product will receive health authority approval or become commercially available for the use being investigated. About vTv Therapeutics vTv Therapeutics is a late-stage biopharmaceutical company focused on developing oral, small molecule drug candidates intended to help treat people living with diabetes and other chronic diseases. vTv’s clinical pipeline is led by cadisegliatin, a potential first-in-class oral glucokinase activator being investigated in a U.S. Phase 3 study for the treatment of T1D. vTv and its development partners are investigating multiple molecules across different indications for chronic diseases. Learn more at vtvtherapeutics.com or follow the company on LinkedIn . Forward-Looking Statements This release contains forward-looking statements, which involve risks and uncertainties. These forward-looking statements can be identified by the use of forward-looking terminology, including the terms “anticipate,” “believe,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” “would” and, in each case, their negative or other variations or comparable terminology. All statements other than statements of historical facts contained in this release, including statements regarding the timing of our clinical trials, the anticipated effect of Phase 3 topline data on the Company, the benefits of cadisegliatin to people living with T1D, our strategy, future operations, future financial position, future revenue, projected costs, prospects, plans, objectives of management and expected market growth are forward-looking statements. These statements involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance, or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Important factors that could cause our results to vary from expectations include those described under the heading “Risk Factors” in our Annual Report on Form 10-K, subsequent Quarterly Reports on Form 10-Q and our other filings with the SEC. These forward-looking statements reflect our views with respect to future events as of the date of this release and are based on assumptions and subject to risks and uncertainties. Given these uncertainties, you should not place undue reliance on these forward-looking statements. These forward-looking statements represent our estimates and assumptions only as of the date of this release and, except as required by law, we undertake no obligation to update or review publicly any forward-looking statements, whether as a result of new information, future events or otherwise after the date of this release. We anticipate that subsequent events and developments will cause our views to change. Our forward-looking statements do not reflect the potential impact of any future acquisitions, mergers, dispositions, joint ventures, or investments we may undertake. We qualify all our forward-looking statements by these cautionary statements. Investor Contact John Fraunces LifeSci Advisors, LLC jfraunces@lifesciadvisors.com Media Contact Caren Begun TellMed Strategies 201-396-8551 caren.begun@tmstrat.com _______________________________ i ii Platt OS. Hydroxyurea for the Treatment of Sickle Cell Anem ia. New England Journal of Medicine . 2008;358:1362-1369.