Affinia Therapeutics (“Affinia”), an innovative clinical-stage gene therapy company with a pipeline of first-in-class and/or best-in-class adeno-associated virus (AAV) gene therapies initially for devastating cardiovascular diseases, today announced that AFTX-201 preclinical and translational data and the Phase 1/2 UPBEAT™ clinical trial investigating AFTX-201 in patients with BAG3-associated dilated cardiomyopathy (DCM), will be featured at the Heart Failure Society of America (HFSA) Annual Scientific Meeting 2026.

Laura Richman, D.V.M., Ph.D., DACVP, Chief Development Officer at Affinia will deliver an oral presentation entitled, “AFTX-201: A low-dose, investigational AAV gene therapy using a cardiotropic capsid for the treatment of BAG3-associated dilated cardiomyopathy: Journey to the clinic,” on Saturday, October 10, 2026 at 1:21 PM PT (abstract 1639; Oral Abstract Session 3A, Stage 1).

“BAG3 DCM represents a substantial unmet medical need, as patients experience an early onset and progressive cardiac dysfunction with no existing approved therapeutic option that addresses the underlying disease mechanism,” said Dr. Richman. “AFTX-201 is designed to address the genetic cause of BAG3 DCM and preclinical studies in an animal model of BAG3 DCM demonstrated a transformative one-time treatment that restored cardiac function and reversed structural abnormalities. We are delighted to advance the UPBEAT clinical trial evaluating AFTX-201 in BAG3 DCM at a number of institutions in the U.S. and Canada so that we can bring a much-needed treatment option to people living with BAG3 DCM.”

Affinia is also sponsoring an industry innovation event that will bring together internationally recognized leaders in cardiovascular medicine and research to review emerging insights in genetic architecture in DCM, gene therapy for BAG3 and other DCMs, and Affinia’s UPBEAT clinical trial. The dinner presentation, “Dilated Cardiomyopathies and Gene Therapy: UPBEAT Clinical Trial in BAG3 DCM with AFTX-201, an Investigational Gene Therapy Using a Low-Dose Cardiotropic Capsid,” will be held Sunday, October 11, 2026 from 7:30-9:00 PM PT at the Sheraton Hotel Ahwatukee Room, Level 2. No RSVP is required.

Ray E. Hershberger, M.D., Professor of Internal Medicine, Cardiovascular Medicine and Human Genetics at The Ohio State University, and Founder and Principal Investigator, Dilated Cardiomyopathy Research Project, and Joshua M. Hare, M.D., FACC, FAHA, the Louis Lemberg Professor of Medicine and Director, Interdisciplinary Stem Cell Institute, at the University of Miami and UPBEAT trial Investigator will be joined by Dr. Richman and Jonathan Plehn, M.D., FACC, Vice President, Clinical Development, Affinia Therapeutics.

About AFTX-201 and the UPBEAT™ Clinical Trial

A potential best-in-class genetic medicine given as a one-time intravenous infusion, AFTX-201 is an investigational medicine designed to address the underlying mutation responsible for BAG3-associated dilated cardiomyopathy (DCM). AFTX-201 is designed to deliver a functional BAG3 transgene utilizing Affinia’s proprietary rationally designed capsid, which is intended to enable clinical doses 5-10-fold lower than those associated with conventional capsids such as AAV9 or AAVrh74. Preclinical studies in an animal model of BAG3 DCM demonstrated that AFTX-201 increased BAG3 protein levels in the heart and restored cardiac function and reversed structural abnormalities.

AFTX-201 is being investigated in the UPBEAT™ clinical trial. The UPBEAT clinical trial is evaluating the safety, tolerability, pharmacodynamics, and preliminary efficacy of AFTX-201 in adults diagnosed with BAG3-associated DCM who experience limitations in performing everyday physical activities due to heart failure. The UPBEAT clinical trial is available at a number of institutions across the U.S. and Canada. The trial is eligible to people who have a BAG3 mutation, are 18 – 70 years old, have reduced left ventricular ejection fraction, and have some difficulty performing normal physical activities. Referring physicians and interested participants are encouraged to reach out via clinicaltrials@affiniatx.com.

The U.S. Food and Drug Administration has accepted Affinia’s Investigational New Drug application for AFTX-201 and granted it Fast Track and Orphan Drug designations in 2026. In addition, the European Medicines Agency has granted Orphan Drug designation to Affinia for AFTX-201 and the company has received Clinical Trial Application approval from Health Canada to advance the UPBEAT clinical trial in Canada.

About BAG3 DCM

BAG3-associated dilated cardiomyopathy (DCM) is a serious, inherited heart condition with a high mortality rate and a significant unmet medical need. The disease affects more than 70,000 people in Canada and the E.U., U.K., and U.S. regions. The BAG3, or Bcl2-associated athanogene 3, gene encodes for a protein that is critical to the normal structure and function of heart cells. Patients with BAG3 DCM have a mutation in the BAG3 gene and a deficiency in functional BAG3 protein, resulting in early onset heart failure that progresses rapidly. Despite current standard of care, almost 25% of patients require a heart transplant.

About Affinia Therapeutics

Affinia Therapeutics is a clinical-stage biotech company pioneering a transformational treatment paradigm shift to a new class of rationally designed gene therapies that treat rare and prevalent diseases. Affinia Therapeutics’ pipeline of first-in-class or best-in-class product candidates, initially in cardiovascular diseases, leverages its proprietary next-generation capsids, payloads, or manufacturing approaches and have shown efficacy, safety, and differentiation in relevant animal models. For more information, visit https://www.affiniatx.com.

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