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VALHALLA THERAPEUTICS Biotechnology for better health Valhalla Therapeutics is a privately-held biopharmaceutical development company that is paving the way for early commercialization of groundbreaking therapeutic technology! Founded in 2019 and based in Berwyn, PA, we're on a thrilling journey to revolutionize healthcare! Our pipeline represents our philosophy of identifying the best unique approaches to fill the underserved therapeutic needs of disease states. As new mechanisms of action can offer a larger impact beyond incremental advances in treatment over current therapies, we strive to develop novel classes of agents possessing breakthrough potential to help patients, reduce healthcare costs and deliver maximal ROI for our investors rather than developing “me-too” follow-on drugs. Halting The Progression Of Type 2 Diabetes: VTX-31 is our most advanced program currently in the pre-IND stage of development. Based on the breakthrough research conducted by Dr. Salim Merali and Dr. Wayne Childers at Temple University, VTX-31 is a designer compound with a novel mechanism of action that directly inhibits the lipotoxicity induced by highly elevated fatty acid levels causing insulin-resistance of Type 2 diabetes and ultimately leading to its complications. Studies in multiple animal models of genetic Type 2 diabetes and diet-induced obesity/Type 2 diabetes have demonstrated reversal of insulin-resistance by increasing glucose uptake into various tissues and providing long-term glucose control. We are actively pursuing private and non-dilutive funding for this program as it is IND-capable. No agent has been developed that directly addresses the underlying cause of T2D Restoring Vascular Blood Flow To Tissues In Type 1 and 2 Diabetes

Meet The Team Founder & CEO Ihor Terleckyj Ph.D 30+ years experience in pharmaceutical industry VP-in-residence, Shifa Biomedical Executive Director, Matinas Director, GSK, Global Product Strategy Scientific Advisor Dr. Salim Merali, Ph.D. Co-founder, VTX-31 inventor Associate Dean of Research, Temple University Carnell Professor of Pharmacy, Temple University School of Pharmacy Head of BD Paul Jeffrey, MBA Global BD and partner-facing experience Head, Clinical Development Douglass Greene, MD Former Chief Medical Officer, Sanofi-Aventis VP, Clinical Science Product Development, Merc Expert in diabetes basic science and clinical R&D Scientific Advisor Dr. Wayne Childers, Ph.D. Co-founder, Inventor VTX-31, VTX-GD Associate Professor of Medicinal Chemistry, Temple University School of Pharmacy Associate Director of the Moulder Center for Drug Discovery Research, Temple University School of Pharmacy Former Senior Scientist, Medicinal Chemistry, Wyeth-Ayerst Research Business Advisor Ezra Felker, MBA Grants Park Advisors Former COO, VenatoRx VP, Operations at NuPath Entrepreneur-in-residence at BioAdvance

VTX-31 The global prevalence of Type 2 diabetes is estimated at 300 million patients, accounting for 12% of global healthcare spending. In the United States, 38 million Americans suffer from diabetes representing 12% of the total population. Left untreated, diabetes leads to the development of kidney disease, neuropathy, retinopathy, poor wound healing, GI dysfunction, cognitive impairment, liver fibrosis and cardiovascular disease. The total healthcare costs for managing diabetes to the US healthcare system is $413 billion. Glucose lowering drugs account for 12% of total diabetes care at $48 billion. Sales of the Top 5 agents for 2023 totaled $33 billion. Even at a 15% effect for an agent that decreases disease progression, the downstream savings to the healthcare system would amount to at least $55 billion.   The Need: Current Type 2 Therapies Lack Durable Glucose Control The GRADE trial sponsored by the NIH NIDDK Institute evaluated agents from all classes for long-term glucose control over a 4 year period. Patients taking metformin were enrolled and study drugs were added to their treatment regimen. At the conclusion of the study, 71% of the patients did not maintain their target HbA1c, the gold standard measure for glucose control, due to ongoing disease progression. While developed to exert glucose lowering effects, none of the current therapies were designed to directly impact the underlying disease pathophysiology 4-HNE Induces Lipotoxicity And Insulin Resistance With overnutrition, high levels of free fatty acids (FFA) are made from glucose and stored as fat in adipose cells. FFAs are also metabolized in the mitochondria through the oxidation cycle. During this process, highly reactive lipoperoxide byproducts are produced, including 4-HNE (4-hydroxynoneal). Under normal circumstances, 4-HNE is deactivated by cellular anti-oxidants such as glutathione. However, in obesity and Type 2 diabetes, larger amounts of 4-HNE are produced due to the increased levels of FFAs that overwhelms the anti-oxidant system. As a result, 4-HNE can bind irreversibly to proteins giving rise to adducts and impair their normal metabolic functioning. The GLUT4 transporter that shuttles glucose from the blood into muscle and fat cells is one of the proteins inactivated by 4-HNE which causes insulin resistance. As a consequence, blood levels of glucose are elevated and adipose cells release stored fatty acids due to the loss of feedback control of metabolic processes. Other tissues and proteins that are inactivated by lipotoxicity include: Pancreatic calmodulin: impaired insulin release and production, beta-cell death Liver ATPase: loss of mitochondrial integrity, decreased ATP synthesis, fatty liver Glutathione synthetase; decreased glutathione synthesis, loss of anti-oxidant   VTX-31 Directly Addresses Underlying Cause Of Insulin-Resistance Orally-available compound specifically designed to bind and neutralize 4-HNE Prevents lipotoxicity by decreasing its availability Decreases protein adduct formation in adipose, pancreas and liver Restores GLUT4 glucose uptake in brown adipose tissue and muscle Decreases HbA1c levels in genetic and diet-induced animal models of disease VTX-31 Exhibits Excellent Drug Properties Roughly 95% oral bioavailability No significant liver metabolism; 99% excretion by kidneys as unchanged compound Half-life supports 2x/day dosing at estimated single doses around 300 mgs Preliminary acute toxicity studies in rat, dog and monkey indicate VTX-31 is well-tolerated with no major adverse events seen at therapeutic doses 6-step simple, low cost synthesis; 1-year minimum stability in capsule form