VTVT — what changed in the latest 10-Q

Text added vs the prior filing · source: 10-Q · 2026-05-13

• In January 2026, the Company entered into the Second Amendment to License Agreement (the "Second Amendment") to provide Newsoara Biopharma Co., Ltd. (“Newsoara”) with global rights to HPP737. In exchange for the global rights, Newsoara paid the Company an upfront amount of $20.0 million and agreed t…

• Under the terms of the Newsoara License Agreement, Newsoara will be responsible for the development and commercialization of the licensed products at its cost, and is required to use commercially reasonable efforts with respect to such development and commercialization efforts.

• Type 1 diabetes (“T1D”) is an autoimmune disease in which the body’s immune system destroys the insulin-producing beta cells of the pancreas. According to the T1D Index, an estimated 1.5 million individuals live with T1D in the United States as of 2026. Patients with T1D have difficulty achieving an…

• Given the lack of oral adjunctive treatments for T1D, several existing therapies developed for type 2 diabetes have been investigated in T1D with limited success, primarily due to safety risks including increased risk of diabetic ketoacidosis (“DKA”). Despite the FDA’s approval of teplizumab (to del…

• Cadisegliatin is a novel, small-molecule, liver-selective glucokinase activator (“GKA”) being evaluated as a potential first-in-class oral adjunctive therapy to insulin for the treatment of T1D. Glucokinase is a key regulator of glucose homeostasis that acts as a physiological glucose sensor; liver-…

Text removed vs the prior filing · source: 10-Q · 2025-11-06

• There have been no material developments since our last reporting period.

• The U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy designation in 2021 for cadisegliatin as an adjunctive therapy to insulin for the treatment of type 1 diabetes. The Breakthrough Therapy designation provides a sponsor with added support and the potential to expedite developmen…

• In May of 2023, the FDA issued new draft guidance on “Diabetes Mellitus: Efficacy Endpoints for Clinical Trials Investigating Antidiabetic Drugs and Biological Products” which, for the first time, permitted the use of hypoglycemia as an endpoint to support a label claim. Consistent with this guidanc…

• In June 2025, the Company initiated a food effect study in healthy volunteers to assess the impact of low or high fats food on the pharmacokinetics of cadisegliatin compared to fasting. The study completed the life phase and data are being analyzed currently.

• Three Months Ended September 30,Nine Months Ended September 30,

Text added vs the prior filing · source: 10-Q · 2026-05-13

• compliance with the policies or procedures may deteriorate. Because of the inherent limitations in a cost-effective control system, misstatements due to error or fraud may occur and may not be detected.