TIXiMED Announces a $2.65M Program-Related Investment from the Helmsley Charitable Trust to Initiate Clinical Trials of Its Novel Oral Therapy for Beta Cell Survival and Function

• TIXiMED is developing TIX100, a proprietary non-immunosuppressive therapy that may become the first oral disease-modifying treatment option for people with type 1 diabetes
• The first-in-human, single ascending dose study of TIX100 will commence in January 2025

TIXiMED, Inc. (https://tiximed.com), a clinical-stage pharmaceutical company based on the breakthrough discovery that TXNIP plays an important role in the development and progression of diabetes, has secured a program-related investment in the form of a $2.65M loan from The Leona M. and Harry B. Helmsley Charitable Trust. The non-dilutive funding will support the advancement of TIX100 into a first-in-human single ascending dose (SAD) study which will commence in January.

TIXiMED recently received FDA Investigational New Drug clearance for TIX100, its oral drug candidate that targets thioredoxin-interacting protein (TXNIP), a detrimental protein that is elevated in diabetes and leads to beta cell death and dysfunction. TXNIP inhibition has been demonstrated in mouse models and in humans with type 1 diabetes (T1D) to protect the body’s own insulin producing cells while promoting overall islet cell health. TIX100 is a potent and specific TXNIP inhibitor designed to target this underlying cause of the disease and has been shown in pre-clinical studies to deliver promising effects in diabetes treatment.

“In suppressing TXNIP with TIX100, our aim is to develop a new therapeutic option to promote the patient’s own beta cell survival, insulin production and pancreatic islet health, an approach that is distinct from any currently approved treatments,” stated Dr. Anath Shalev, TIXiMED founder and Chief Scientific Officer. “Our SAD study of TIX100 is an exciting step to help bring this new, disease-modifying treatment to market and change the treatment landscape,” Dr. Shalev added.

“TIXiMED is pleased to receive this significant financial support from the Helmsley Charitable Trust. With it, we are poised to rapidly begin our SAD study in human subjects next month,” said the TIXiMED President, Michael Goodrich. “Helmsley has a tremendous commitment and a rich history in advancing novel therapies for T1D and we are proud to have them alongside supporting our efforts,” Mr. Goodrich stated.

“To date, beta-cell targeted therapies that could treat and delay the progression of T1D are an untapped strategy. Therapies such as TIX100 could fulfill an unmet medical need and improve the lives of people living with T1D,” said Dr. Ben Williams, Program Officer at the Helmsley Charitable Trust. “This program-related investment will support the efforts of TIXiMED to develop an innovative oral therapeutic for beta cell health and function, bringing T1X100 one step closer to people with T1D,” Dr. Williams concluded.

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.

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