TIXiMED Announces Expansion of Program-Related Investment from the Helmsley Charitable Trust

Expanded Charitable Funding will Support Phase 1 Multiple Ascending Dose Trial and Long-Term Toxicology Studies for TIX100, a Novel Oral Therapy Targeting Beta Cell Health in Type 1 Diabetes

BIRMINGHAM, Ala.--(BUSINESS WIRE)--TIXiMED, Inc., a clinical-stage pharmaceutical company developing innovative therapies for diabetes based on the breakthrough discovery of the role of TXNIP in disease progression, today announced the expansion of a program-related investment (PRI) made by The Leona M. and Harry B. Helmsley Charitable Trust in furtherance of their charitable purpose. The expanded PRI, in the form of a loan, provides TIXiMED with an additional $2.2 million to support the company's multiple ascending dose (MAD) Phase 1b clinical trial and long-term toxicology studies for TIX100, its investigational oral therapy designed to promote beta cell survival and function in individuals with Type 1 Diabetes (T1D).

The Helmsley Charitable Trust’s original $2.65 million PRI, in December 2024, enabled TIXiMED to successfully complete its Phase 1a single ascending dose (SAD) study, which demonstrated that TIX100 was safe and well-tolerated in healthy subjects, while also providing an early, promising metabolic signal. The additional $2.2M in PRI funds announced today will enable a Phase 1b MAD clinical trial and long-term toxicology studies, thereby advancing the research closer to Phase 2 trials of TIX100 in patients with T1D. TIX100 targets thioredoxin-interacting protein (TXNIP), a key driver of beta cell dysfunction and death, promising a disease-modifying approach beyond traditional insulin management.

"We are deeply appreciative of the ongoing interest and support from the Helmsley Charitable Trust as we advance our TIX100 program," said Stephen Daly, Chief Executive Officer of TIXiMED. "This additional funding, bringing Helmsley’s total commitment to $4.85 million, allows us to conduct the MAD trial and to complete the necessary long-term toxicology studies. These critical steps will position the program for future clinical evaluation in people facing type 1 diabetes, bringing us closer to delivering a transformative oral therapy that addresses an underlying cause of beta cell loss."

Dr. Ben Williams, Program Officer for the Type 1 Diabetes Program at the Helmsley Charitable Trust, added, "TIXiMED continues to make progress developing TIX100 as a potential first-in-class disease-modifying therapy for T1D. Our support of TIXiMED with TIX100 aligns with our mission to support innovative approaches that could meaningfully improve lives for people with T1D."

Dr. Anath Shalev, Founder and Chief Scientific Officer of TIXiMED, added, "This continued support from the Helmsley Charitable Trust allows us to advance TIX100 as a potential first-in-class, oral, disease-modifying therapy for type 1 diabetes. Building on the positive safety and early metabolic signals from our SAD study, advancing to the MAD phase and long-term toxicology will bring us one step closer to meaningful impact for patients."

About TIXiMED, Inc.

TIXiMED is a clinical stage pharmaceutical company dedicated to developing and commercializing a first-of-its kind oral therapy for type 1 diabetes based on TXNIP inhibition. TIXiMED is the exclusive license holder for the patent surrounding TIX100, a novel, small molecule TXNIP inhibitor, and its derivatives, that has been shown to protect against models of type 1 and type 2 diabetes as well as metabolic dysfunction–associated steatotic liver disease. Visit www.tiximed.com for more information.