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advancing innovative exosome-based therapies
for Inflammation & Immunology

INTENT Biologics is committed to developing novel regenerative exosome biologics that address significant unmet medical needs. Our pipeline is specifically designed to treat topical and subdermal chronic wounds and autoimmune dermatologic conditions, areas where traditional therapies often fall short.

PEP Biologic™ (Purified Exosome Product)
A Platform Biotechnology

Our flagship product candidate, PEP Biologic™, is a first-in-class topical biologic harnessing the regenerative power of platelet-derived exosomes. Clinically validated and strategically positioned for multiple indications, PEP Biologic™ represents a transformative approach in treating severe wounds and autoimmune skin diseases.

Key Features:

  • Topical biologic with polyvalent regenerative action.
  • Sustained, targeted delivery at the site of injury or inflammation.
  • Highly scalable, proprietary manufacturing process (developed by RION).
  • Demonstrated superior efficacy compared to current standard-of-care treatments.
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Advanced Tissue Regeneration Pipeline

Our advanced wound care program leverages compelling clinical and compassionate-use data to rapidly advance toward regulatory approval across multiple indications:

Indication Phase 1 Phase 1b Phase 2 Phase 3 Commercialized
Unmet Need: Only 24% heal at 12 weeks with standard care
U.S. Market Size: $6.0B
Unmet Need: Near 0% heal with current treatments
U.S. Market Size: $0.5 Billion
Unmet Need: ~50% heal at 12 weeks with standard care
U.S. Market Size: $5.4 Billion
Unmet Need: 85% heal within 1 year with standard care
U.S. Market Size: $1.0 Billion
Unmet Need: 30–60% heal within 24 weeks with standard care
U.S. Market Size: $5.3 Billion
Phase 3
Unmet Need: Only 24% heal at 12 weeks with standard care
U.S. Market Size: $6.0B
Phase 1b
Unmet Need: Near 0% heal with current treatments
U.S. Market Size: $0.5 Billion
Phase 3
Unmet Need: ~50% heal at 12 weeks with standard care
U.S. Market Size: $5.4 Billion
Phase 3
Unmet Need: 85% heal within 1 year with standard care
U.S. Market Size: $1.0 Billion
Phase 3
Unmet Need: 30–60% heal within 24 weeks with standard care
U.S. Market Size: $5.3 Billion

Clinical
Milestones

  • Completed successful Phase 2 trial in DFU showing significantly enhanced healing (54% vs. 25% standard care at 12 weeks).
  • Compassionate-use successes in chronic wounds previously unresponsive to treatment (radiation ulcers, venous leg ulcers).
  • Expanded Access Program (EAP) planned for non-healing chronic wounds (Q3 2025).

Autoimmune Dermatology Pipeline

Our autoimmune dermatology program focuses on innovative, non-immunosuppressive topical
therapies that effectively modulate inflammatory responses and repair skin barriers.

Indication Phase 1 Phase 1b Phase 2 Phase 3 Commercialized
Atopic Dermatitis (AD)
Unmet Need: Only 24% heal at 12 weeks with standard care
U.S. Market Size: $5.8 Billion
Psoriasis (PsO)
Unmet Need: Despite biologics and oral options, more precise, safer, and affordable long‑term systemic treatments are still needed.
U.S. Market Size: $3.7B
Vitiligo
Unmet Need: There’s a lack of consistently effective, durable repigmentation therapies and relapse prevention.
U.S. Market Size: $0.5B
Seborrheic Dermatitis (SD)
Unmet Need: Treatments are limited by inconsistent efficacy, side effects, and poor consideration of diverse skin types.
U.S. Market Size: $1.1B
Subdermal
U.S. Market Size: $3.4B
Phase 3
Unmet Need: Only 24% heal at 12 weeks with standard care
U.S. Market Size: $5.8 Billion
Phase 3
Unmet Need: Despite biologics and oral options, more precise, safer, and affordable long‑term systemic treatments are still needed.
U.S. Market Size: $3.7B
Phase 3
Unmet Need: There’s a lack of consistently effective, durable repigmentation therapies and relapse prevention.
U.S. Market Size: $0.5B
Phase 3
Unmet Need: Treatments are limited by inconsistent efficacy, side effects, and poor consideration of diverse skin types.
U.S. Market Size: $1.1B
Phase 1
U.S. Market Size: $3.4B

Clinical
Milestones

    • Positive preclinical results showing potent anti-inflammatory effects comparable to high-potency steroids (without side effects).

       

    • IND accepted for Phase 2/3 study in atopic dermatitis scheduled for mid 2026. Psoriasis, vitiligo, and SD will follow thereafter with Phase 3 start in 2028.

    Future Expansion

    • Planned expansion into additional autoimmune indications, including alopecia areata, cutaneous graft vs. host disease, cutaneous lupus, and lichen planus.
Clinical Development Timeline
  • 2025
  • 2026 - 2027
  • 2028

• Initiation of Phase 3 Diabetic Foot Ulcer trial
• Phase 1b/2a Chronic Radiation Ulcer trial (DoD-funded)
• IND filing and initiation of Phase 1b Atopic Dermatitis study
• Expanded Access Program launch for chronic wounds

• Initiation of Phase 3 pivotal trials for Pressure Ulcers, Surgical Wounds, and Venous Leg Ulcers
• Phase 2/3 initiation for Atopic Dermatitis

• Anticipated Biologics License Application (BLA) submission for Diabetic Foot Ulcer indication
• Label expansions into additional chronic wound indications via supplemental filings
• Phase 3 starts planned for psoriasis, vitiligo, SD

Publications

INTENT Biologics remains dedicated to transparency and scientific rigor, reflected in numerous peer-reviewed publications and scientific presentations validating our exosome-based therapeutic approach.

Learn More
White molecular network representing exosome signaling pathways used in INTENT Biologics’ therapeutic platform.

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Chris Paradise, Ph.D.
Vice President Research & Development

Dr. Chris Paradise serves as Vice President of RION’s Research and Development team. He holds a PhD in Molecular Pharmacology and Regenerative Medicine from the Mayo Clinic in Rochester, MN. Before joining Rion, Chris’s research efforts focused on engineering adult stem cells and evaluating their utility as a therapeutic strategy for tissue regeneration. His work in the Regenerative Medicine space and has been recognized by prominent international societies and has resulted in over forty peer-reviewed publications.

Chris contributes in-depth technical knowledge of stem cell biology and tissue regeneration to RION’s Research and Development team and continues to leverage this expertise to advance RION’s development of extracellular vesicle-based platforms. He is driven by a desire to translate laboratory innovation into clinical-grade therapies that improve the lives of patients.

Scott McCrea, MBA
Senior Vice President of Business Development

Scott brings over 23 years of business development and commercial experience across pharmaceutical, medical device, and cosmeceutical sectors. He has extensive experience in evaluating and commercializing medical dermatology, medical aesthetics, and consumer skincare products. Scott has a deep understanding of asset valuation and negotiation strategy that led to multiple acquisitions and licensing opportunities during his career.

Most recently, Scott was responsible for developing commercial aesthetics partnering opportunities as Director of Commericla Development for Aesthetics North America at Galderma, the wold’s largest independent global dermatology company (private equity owned).

Scott holds a Master of Business Administration from the University of Houston – C.T. Bauer College of Business and a bachelor’s degree in industrial distribution from Texas A&M University.

Jahan Jowharchi, MBA
Chief Technology Officer

Mr. Jowharchi has more than 30 years of experience in the life science industry in the area of Technical Operations. He has overseen clinical and commercial product development in engineering, operations management, and quality systems specifically in small molecules, biologics, and antibody drug conjugates with particular focus on oncology, regenerative medicine, and immunology. He has extensive experience in product life cycle management from development to clinical and commercial manufacturing, product launches as well as in support of post marketing surveillance and pharmacovigilance. Before joining RION, he supervised the contract research, development, and manufacturing organization for start-ups such as Raptor Pharmaceuticals, and Heron Therapeutics, and he served in management and leadership positions at biopharmaceutical companies such as Genentech and Novo Nordisk. He also managed a number of consulting firms and divisions to support big pharma and start-ups in the areas of facilities design, systems engineering, and operational readiness. Mr. Jowharchi holds a B.S. in mechanical engineering from the University of Massachusetts Amherst and an executive MBA from Saint Mary’s College in California.

Maureen Merrifield Ph.D.
Chief Regulatory Officer

Dr. Merrifield serves as Chief Regulatory Officer at RION. She brings more than 15 years of experience in the pharmaceutical industry to RION. She has led the regulatory strategy and submissions for products from discovery to commercialization, with significant expertise in cell and gene therapy products, monoclonal antibodies, vaccines, and protein therapies. She has regulatory expertise in Chemistry, Manufacturing, and and Controls (CMC), including non-clinical and clinical aspects of pharmaceutical development. She has been the lead of global pharmaceutical teams consisting of clinical, preclinical, CMC, statistician, and pharmacovigilance staff to advance therapeutic products through the development stages. Prior to RION, she has held the following positions: Vice President, Clinical and Regulatory Affairs at Pharmatech Associates; Director of Regulatory and Strategic Development at Clinipace Worldwide; Director of Regulatory Affairs at Bellicum Pharaceuticals; Regulatory and Affairs Project Manager at Sabin Vaccine Institute; and senior scientific roles at Sanofi and GSK. She earned both a Ph.D. and B.S. in chemistry from Western University.

Charlie Farrahar
Chief Financial Officer

Mr. Farrahar is Chief Financial Officer (CFO) at Rion and a Certified Public Accountant with more than 30 years of managerial finance, administration, human resources, investor relations, and risk management experience in the public, private, and non-profit sectors. In addition to his work at RION, Mr. Farrahar serves as CFO for several small biotech startups in various stages of development. Prior to Rion, he was CFO of Medovex Corp (now H-CYTE), a public medical biosciences company focused in the field of regenerative medicine. Before Medovex, Mr. Farrahar served as CFO and Director of Human Resources at a private governmental assistance startup, where he assisted with the sale of that company to a private equity group after it had grown into a multi-state operation with more than 400 employees.

Atta Behfar, M.D., Ph.D.
Chief Medical Officer

Dr. Behfar is the Russ and Kathy Van Cleve Professor of Regenerative Medicine at Mayo Clinic. His work has led to the development of several regenerative technologies, including cardiopoietic stem cells, which completed phase 2 and 3 trials in Europe. Over the last 15 years, Dr. Behfar has focused on the design of novel exosomes for delivery of critical signals essential to facilitate cell-free endogenous repair. Discovery of regenerative platelet-derived exosomes serve as the basis for Rion with an eye towards developing technological platforms that fundamentally change the approach to regenerative medicine by delivering low cost and off-the-shelf therapies for broad array of medical applications. In addition to being cofounder of Rion, he is Director of Van Cleve Cardiac Regenerative Medicine Program at Mayo Clinic, where he specializes in heart transplant and invasive cardiac procedures. Previously, Dr. Behfar was Director of Research at Cardio3 BioSciences, which was acquired by Celyad Oncology, after which he served as Special Scientific Advisor. Dr. Behfar holds an M.D. from the Mayo Clinic School of Medicine and a Ph.D. in stem cell biology and molecular pharmacology and therapeutics from the Mayo Clinic Graduate School of Biomedical Sciences. He earned his undergraduate degree is in biochemistry and mathematics from Marquette University.

Suneet Varma, MBA
Chief Executive Officer

Suneet Varma was recently Global and U.S. President, Oncology. During his tenure, Pfizer rose to become the third largest oncology company in the USA in 2024 with an industry- leading portfolio of 25+ approved medicines across more than 40 indications. Before leading Oncology, Suneet served as Global President of Rare Diseases, one of Pfizer’s fastest growing, high science units, which included a targeted gene therapy program.

Prior to that role, Suneet was the charter Global President of the Hospital Unit focused on both primary and alternative patient sites of care and therapeutic areas such as Anti-Infectives, Blood Management, Pain & Anesthesia amongst a dozen others. As part of this complex portfolio of ~300 treatments, approximately 50 medicines were also on the WHO essential medicines list. Further, he also over saw the company’s CDMO, Pfizer CentreOne and DoD unit, Meridian Medical Technologies, in this role.