What Aegle Therapeutics does

Aegle Therapeutics is a clinical-stage biotechnology company developing cell-free extracellular vesicle (EV) therapies derived from bone marrow mesenchymal stem cells (MSCs). Founded in 2015 and headquartered in Woburn, Massachusetts with an additional office in Miami, Florida, the company focuses on rare dermatological and immunologic diseases with significant unmet medical need. Its lead product candidate AGLE-102™ is a therapeutic composite of MSC-derived EVs, including exosomes, carrying COL7 protein and COL7A1 mRNA designed to induce collagen VII production in patients with Recessive Dystrophic Epidermolysis Bullosa (RDEB), a rare pediatric monogenetic disorder causing severe skin blistering, disfigurement, and shortened lifespan.

The platform is built on a proprietary EV harvesting technology exclusively licensed from the University of Miami that isolates EVs from MSCs without damaging or modifying them, an approach that distinguishes Aegle from conventional EV isolation methods that can trigger inflammatory responses. AGLE-102 is currently in a Phase 1/2 clinical trial (NCT04173650) for RDEB, with the first patient dosed in August 2024. The pipeline also includes a completed pilot study in severe burns (NCT05078385) funded by a U.S. Department of Defense CDMRP grant, and preclinical work in Graft versus Host Disease prophylaxis. Aegle has received FDA IND clearance for both burn (2018) and DEB (2019) indications, plus Rare Pediatric Disease Designation and Fast Track Status for AGLE-102 in October 2020.

As a pre-revenue company, Aegle generates no commercial product sales and relies on equity and debt financings to fund operations. Disclosed funding to date includes a $4M financing (January 2020), a $6.5M Series A (September 2020), a $3M DeepWork Capital investment (April 2022), and a $700K debt offering (March 2026), aggregating roughly $10.5M-$14.2M. Upon FDA approval, the company plans to commercialize through traditional pharmaceutical channels including specialty pharmacies and hospital systems, targeting orphan/rare disease pricing economics. The company is led by CEO Shelley Hartman (former Goldman Sachs Managing Director), Founder/CSO Dr. Evangelos Badiavas (a board-certified dermatologist with three FDA INDs), and Chairman Dr. Scott Braunstein (former CEO of Marinus Pharmaceuticals, sold to Immedica Pharma).

Name

Aegle Therapeutics

Legal name

Aegle Therapeutics Corp.

Website

https://aegletherapeutics.com

Company type

Private

Founded year

2015

Operating status

Operating

Headcount range

1–10 employees

Short description

Aegle Therapeutics is a clinical-stage biotech developing AGLE-102, a first-in-class MSC-derived extracellular vesicle therapy for rare pediatric diseases, with its lead program in Phase 1/2 trials for Recessive Dystrophic Epidermolysis Bullosa.

Ownership category

akta.pro rank

Product category

Regenerative Medicine Biologics

NAICS

Biological Product (except Diagnostic) Manufacturing (325414), Research and Development in Biotechnology (except Nanobiotechnology) (541714)

SIC

Biological Products, (No Disgnostic Substances) (2836)

akta.pro primary industry

Rare Dermatology Disorder Therapies (HLAIAIAM)

akta.pro secondary industries

Stem Cell Therapies (MSC/iPSC/HSC-derived) (HLAAABAE), Regenerative Immunology & Inflammation Modulation (pro-regenerative biologics) (HLAAAGAL)

Keywords

• Regenerative medicine therapeutics
• Extracellular vesicle therapy
• Rare disease biopharmaceuticals
• Stem cell-derived exosomes
• Cell-free biologics

Headquarters

HQ city

Miami

HQ country

United States

HQ region

North America

Offices2 records

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

Technology or R&D, Personnel, Operations, Marketing or Sales, Infrastructure

Revenue model

1. Pharmaceutical/Biologic Product Sales: Pre-revenue clinical stage company. Upon FDA approval of AGLE-102 and future pipeline products, revenue will be generated through sales of FDA-approved biologic therapies for rare diseases including dystrophic epidermolysis bullosa and other dermatological disorders.

Go-to-market motion1 record

Distribution channels1 record

Marketing channels5 records

Core offering

Aegle Therapeutics is a clinical-stage biopharmaceutical company developing cell-free extracellular vesicle (EV) therapies derived from bone marrow mesenchymal stem cells (MSCs). Its lead product AGLE-102 is in Phase 1/2 clinical trials for Recessive Dystrophic Epidermolysis Bullosa (RDEB), with additional programs in severe burns and Graft vs. Host Disease. The proprietary platform delivers natural biomolecular payloads including COL7 protein and COL7A1 mRNA to diseased and damaged cells for regenerative treatment of rare dermatological and immunological disorders.

Product overview

Aegle Therapeutics is a clinical-stage biotechnology company developing a single unified therapeutic platform based on mesenchymal stem cell (MSC)-derived extracellular vesicles (EVs). The lead product AGLE-102™ is a first-in-class EV therapy currently in Phase 1/2a clinical trials for Recessive Dystrophic Epidermolysis Bullosa (RDEB), with additional programs in burns (completed pilot study) and Graft vs. Host Disease (preclinical). The company leverages its proprietary EV harvesting technology, exclusively licensed from the University of Miami, to produce cell-free therapies that deliver therapeutic biomolecules to diseased and damaged cells.

Differentiator

Problem solved

Functional benefit

Products and services

• AGLE-102 AGLE-102 is a first-in-class therapeutic composite of extracellular vesicles (EVs), including exosomes, isolated from bone marrow-derived mesenchymal stem cells (MSCs) using Aegle's proprietary EV harvesting technology. It contains COL7 protein as well as COL7A1 mRNA and is designed to treat Recessive Dystrophic Epidermolysis Bullosa (RDEB) by inducing fibroblasts to produce COL7 and promote functional skin tissue regeneration. It is non-immunogenic and carries immunomodulating and anti-inflammatory properties.
• MSC-Derived Extracellular Vesicle (EV) Therapy Platform The MSC-Derived Extracellular Vesicle (EV) Therapy Platform is Aegle's proprietary technology platform that isolates EVs from bone marrow-derived mesenchymal stem cells without damaging or modifying the vesicles, using patented harvesting technology exclusively licensed from the University of Miami. It harnesses the regenerative, immunomodulatory, and anti-inflammatory properties of MSC-derived EVs to deliver natural biomolecular payloads (proteins, microRNAs, messenger RNAs, and skin basement membrane proteins such as collagen IV and collagen VII) to treat disorders with significant unmet medical need.

Quantifiable outcome

• Phase 1/2 clinical trial for RDEB now enrolling with positive first patient data announced January 2024
• +2 more outcomes

Segments3 records

Ideal customer profiles2 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature3 records

Partnerships

One partnership is on record.

• University of MiamicoreStrategic or Co-development PartnerUniversity of Miami exclusively licensed Aegle's patented EV harvesting technology. Dr. Evangelos Badiavas, Founder and CSO, has research history with the University of Miami. Aegle has published research conducted in collaboration with University of Miami researchers on wound healing and stem cell-derived EVs.

Scale indicators6 records

Recent moves6 records

Expansion highlights5 records

Direct peers

• Capricor Therapeutics: Clinical-stage biotech developing exosome/EV-based therapeutics (deramiocel, lead asset for Duchenne muscular dystrophy) using cardiosphere-derived cell EVs. Closest direct peer to Aegle given shared EV/exosome modality and rare-disease focus, though with a different therapeutic area.
• Krystal Biotech: Commercial-stage biotech whose lead product Vyjuvek is an FDA-approved topical gene therapy for DEB. Directly competes with AGLE-102 in the same patient population and represents the benchmark Aegle must beat on efficacy, convenience, and durability.
• Abeona Therapeutics: Develops cell and gene therapies for rare diseases including recessive DEB (EB-101 was approved by FDA as Zevaskyn in 2025). Direct DEB competitor to AGLE-102 with overlapping patient population and similar rare-disease commercial dynamics.
• Evox Therapeutics: UK-based developer of engineered exosome therapeutics (e.g., for rare metabolic and CNS indications). Closest modality peer to Aegle's MSC-EV platform with comparable exosome engineering and proprietary isolation IP.
• ExoCoBio: South Korea-based clinical-stage developer of exosome-based therapeutics for atopic dermatitis, sepsis, and rare diseases. Directly comparable to Aegle in modality (exosome therapeutics) and overlap in dermatology indications.
• Direct Biologics: Clinical-stage regenerative medicine company developing bone marrow MSC-derived EV products (ExoFlo) for inflammatory and regenerative indications including wound healing. Comparable to Aegle in MSC-EV platform and overlapping wound/burn use cases.

Emerging players

• Castle Creek Biosciences: Late-stage cell- and gene-therapy developer for rare dermatological diseases including DEB (dabocemagene autoficel). Competes with AGLE-102 in the same DEB patient segment using a different (autologous gene-modified cell) modality.
• Phoenix Tissue Repair: Preclinical/early-clinical developer of a recombinant collagen VII protein therapy for RDEB. Competes with AGLE-102 in the same COL7-deficient patient population using a different (recombinant protein) approach — useful comparator for evaluating AGLE-102's clinical and commercial profile.
• Ilias Biologics: Clinical-stage developer of engineered exosome-based therapeutics (e.g., ILB-001 for sepsis-related inflammatory disease). Comparable modality to Aegle with overlapping anti-inflammatory/immunomodulatory mechanism of action derived from EV/exosome biology.

Others

• RoosterBio: Supplier of human MSC and EV products and manufacturing platforms used by regenerative medicine developers. Comparable because RoosterBio's MSC-EV raw material and process technology is an enabling input for any MSC-EV therapeutic including Aegle's platform.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat4 records

Key risks6 records

Key highlights7 records

Customer concentration

• LinkedInlinkedin.com/company/aegletherapeutics

Revenue estimate

Valuation estimate

Number of profiles

Profiles9 records

Funding overview

Funding rounds6 records

Investors6 records

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Aegle Therapeutics