Secretome Therapeutics to Present Phase 1 Clinical Data Evaluating STM-01 in Heart Failure with Preserved Ejection Fraction at HFSA Annual Scientific Meeting

PLANO, Texas--(BUSINESS WIRE)--Secretome Therapeutics, a clinical-stage biotechnology company developing novel therapies derived from neonatal cardiac progenitor cells (nCPC), today announced that clinical data from its Phase 1 study evaluating STM-01 in patients with heart failure with preserved ejection fraction (HFpEF) will be presented at the Heart Failure Society of America (HFSA) Annual Scientific Meeting.

STM-01 is an investigational biologic therapy derived from neonatal cardiac progenitor cells. The mechanism of action for STM-01 includes anti-inflammatory, angiogenic, anti-fibrotic, and tissue-repair properties, with the potential to address biological processes implicated in the pathophysiology of HFpEF.

The presentation, titled “Phase 1, Safety and Tolerability of STM-01 in Heart Failure with Preserved Ejection Fraction (HFpEF),” will be presented by Ambarish Pandey, MD, Professor of Internal Medicine and Frederick G.L. Huetwell Research Professor of Cardiovascular Medicine, and Director of the Center for Cardiometabolic Research at the University of Michigan.

The Phase 1 open-label, dose-escalation study enrolled 10 patients with HFpEF across two dose cohorts. Five patients received 100 million cells and five received 200 million cells, administered on Day 0 and Day 28, with follow-up through Day 56. Clinical assessments included safety, echocardiography, six-minute walk testing (6MWT), Kansas City Cardiomyopathy Questionnaire (KCCQ), and biomarkers.

“We are pleased to present the first clinical findings from our STM-01 program in HFpEF at HFSA,” said Ambarish Pandey, MD “HFpEF is a complex and heterogeneous disease in which inflammation, microvascular dysfunction, and fibrosis may contribute to disease progression. These Phase 1 findings provide important initial clinical experience with STM-01, which was given on top of GLP-1s and SGLT2 inhibitors in a majority of patients. This supports the continued evaluation of its potential as a novel therapeutic approach for patients with HFpEF."

STM-01 was well tolerated across both dose levels, with no treatment-related treatment-emergent adverse events (TEAEs) or treatment-related serious TEAEs reported. No deaths or TEAEs leading to discontinuation, withdrawal, or treatment interruption were observed. Nine TEAEs were reported among five participants, and none were considered related to STM-01.

Exploratory findings showed generally favorable trends in health status and exercise capacity, with variability across participants and endpoints. Over 56 days, KCCQ scores and six-minute walk distance increased, while E/e′ and stroke volume remained broadly stable. Specifically, seven of 10 participants experienced a greater than 5-point improvement in KCCQ score, a change considered clinically meaningful. NT-proBNP responses were heterogeneous and showed no statistically significant change. Given the small sample size and open-label Phase 1 study design, these findings are exploratory and require further evaluation in larger clinical studies.

Presentation Details
Title: Phase 1, Safety and Tolerability of STM-01 in Heart Failure with Preserved Ejection Fraction (HFpEF)
Presenter: Ambarish Pandey, MD, University of Michigan (Formerly at UT Southwestern Medical Center)
Meeting: Heart Failure Society of America Annual Scientific Meeting
Date: October 11, 2026
Time: 8:21 - 8:31AM MST
Session/Location: Oral Abstract Presentation Sessions - Oral Abstract Session 5A [Poster no. 058]

About STM-01

STM-01 is an investigational biologic therapy derived from neonatal cardiac progenitor cells. The therapy is designed to harness the regenerative activity of the cells’ secretome, which contains naturally occurring bioactive factors with anti-inflammatory, angiogenic, anti-fibrotic, and tissue-repair properties. By modulating biological pathways involved in inflammation, fibrosis, angiogenesis, and tissue repair, STM-01 is being developed as a potential treatment for serious cardiovascular and neuromuscular diseases.

About Heart Failure with Preserved Ejection Fraction

Heart failure with preserved ejection fraction is a complex clinical syndrome characterized by signs and symptoms of heart failure despite preserved left ventricular ejection fraction. HFpEF accounts for approximately half of all heart failure and is associated with substantial impairment in exercise capacity and quality of life, frequent hospitalization, and loss of functional independence. Chronic systemic inflammation associated with common comorbidities, including obesity, diabetes, hypertension, and chronic kidney disease, may contribute to coronary microvascular dysfunction, myocardial stiffness, and fibrosis in HFpEF.

About Secretome Therapeutics

Secretome Therapeutics is a clinical-stage biotechnology company developing regenerative medicines derived from proprietary neonatal cardiac progenitor cell technology for the treatment of serious diseases with significant unmet medical need. The company’s platform leverages the regenerative potential of the cellular secretome to develop therapies that target inflammation, fibrosis, and tissue repair across multiple disease areas.