RION Launches INTENT Biologics to Develop Late-Stage Clinical Exosome-Based Therapies in Inflammation & Immunology; Appoints Biopharma Veteran Suneet Varma as CEO

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ROCHESTER, Minn.--(BUSINESS WIRE)--Sep 9, 2025--

RION, a clinical-stage regenerative medicine company and global leader in exosome-based therapeutics, today announced the formation of INTENT Biologics, a new independent biotechnology company focused exclusively on developing first-in-class exosome therapies for Inflammation & Immunology (I&I). INTENT Biologics launches with exclusive, perpetual worldwide rights to RION’s Purified Exosome Product (PEP™) biologic platform in I&I and will advance PEP Biologic™ into Phase 3 clinical development for advanced tissue regeneration and immune-mediated dermatologic indications.

Suneet Varma has been appointed Chief Executive Officer of INTENT Biologics. Varma brings over 30 years of global biopharma leadership, including his tenure as Global President of Pfizer Oncology and Rare Diseases and recent service on the Board of Directors at Cerevel Therapeutics.

“Creation of INTENT Biologics marks a pivotal milestone in our mission to revolutionize standards of care through regenerative exosome science,” said Atta Behfar, M.D., Ph.D., Co-Founder of RION. “By creating a company with dedicated focus on deploying our exosome platform in I&I, we can accelerate the clinical and commercial path for PEP Biologic and unlock its potential across multiple high impact indications.”

“INTENT Biologics is uniquely positioned to redefine therapeutic approaches in Inflammation & Immunology with a novel mechanism of action that harnesses regenerative exosomes to restore immune balance and reduce inflammation which, in turn, promotes optimal healing across many diseases and patient subpopulations,” said Suneet Varma, CEO of INTENT Biologics. “With a $30B+ market opportunity and a highly de-risked clinical path, we are poised to rapidly advance PEP Biologic™ into late-stage pivotal trials.”

INTENT Biologics leverages RION’s proprietary, industry-leading platelet-derived exosome biomanufacturing platform to produce PEP Biologic at clinical and commercial scale. Packaged as a shelf-stable lyophilized powder, each dose contains regenerative exosomes designed to deliver polyvalent biologic signals that reduce inflammation, regulate immune responses, and promote tissue regeneration.

About PEP Biologic™

PEP Biologic (Purified Exosome Product) is a first-in-class exosome therapeutic discovered through Mayo Clinic Van Cleve Cardiac Regenerative Medicine Program and developed on RION’s industry-leading platelet-derived exosome biomanufacturing platform. Packaged as a shelf-stable lyophilized powder, each dose contains regenerative exosomes that deliver polyvalent biologic signals to induce tissue regeneration and regulate immune responses for accelerated healing. With a novel mechanism of action that emphasizes modulation of T-cells and polarization of resident embryonic macrophages to promote tissue regeneration, PEP Biologic is being advanced by INTENT Biologics into late-stage clinical trials for a range of advanced tissue regeneration and immune-mediated dermatologic indications where current treatments fail to address the underlying biology.

About INTENT Biologics

INTENT Biologics is a clinical-stage biotechnology company dedicated to developing first-in-class exosome-based therapeutics in Inflammation & Immunology (I&I). Spun out of RION, a global leader in regenerative exosome science, and built on more than two decades of research at the Mayo Clinic, INTENT is advancing PEP Biologic into late-stage clinical development for multiple indications in advanced tissue regeneration and immune-mediated dermatologic conditions. Headquartered in Minnesota, the company is focused on “revolutionizing and replacing” standards of care in I&I by harnessing regenerative exosomes to treat diseases with significant unmet need. More information can be found at www.intent.bio.

About RION

RION is a clinical-stage regenerative medicine company founded out of the Mayo Clinic after two decades of stem cell and exosome research and innovation. RION is the global leader in isolating and mass-producing platelet-derived regenerative exosomes into a proprietary therapeutic platform to produce Purified Exosome Product (PEP), a shelf-stable biologic designed to activate the body’s natural healing processes. RION is advancing a deep pipeline with clinical and preclinical programs in diabetic foot ulcers, knee osteoarthritis, musculoskeletal injury, dermatologic conditions, pulmonary disease, cardiovascular health, and women’s health. RION’s regenerative PEP technology will be integral to the therapeutic exosome revolution. More information can be found at www.riontx.com.

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SOURCE: RION

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PUB: 09/09/2025 09:00 AM/DISC: 09/09/2025 08:59 AM

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