What Trefoil Therapeutics does

Trefoil Therapeutics is a privately held, clinical-stage biotechnology company developing first-in-class engineered Fibroblast Growth Factor-1 (FGF-1) therapeutics for corneal diseases. Founded around 2015 and headquartered in San Diego, California, the company is advancing a single engineered molecule, TTHX1114, in two formulations: an intracameral injection targeting corneal endothelial decompensation associated with Fuchs Endothelial Corneal Dystrophy (FECD) — the leading cause of corneal transplantation in the United States — and Descemet Stripping Only (DSO) surgery, and a topical eye drop formulation for corneal epithelial defects and ulcerative conditions affecting the front surface of the cornea. The underlying platform technology is exclusively licensed from Florida State University (developed by co-founder Dr. Michael Blaber) and comprises engineered FGF-1 mutants with improved functional half-life relative to naturally occurring FGF1, enabling pharmaceutical use.

The business model is a standard clinical-stage biotech model: Trefoil generates no current revenue, invests venture and grant capital into clinical development of TTHX1114, and intends to commercialize the product upon regulatory approval through engagement with ophthalmology practices, hospitals, and surgical centers. To date, the company has raised approximately $45 million in venture financing across a $5.2 million Series 1 (2017, led by Hatteras Venture Partners) and a $28 million Series A (2019, led by Bios Partners), supplemented by a $12 million SEC-registered securities offering (2022) and a $4.56 million raise in 2025. Non-dilutive capital has come from NIH (R21 grant exceeding $500,000, plus a CRADA with NCATS under the TRND program) and the U.S. Department of Defense for proof-of-concept topical studies. The lead clinical program (TTHX1114 intracameral) is in Phase 2 (STORM trial) following completion of Phase 1/2 (INTREPID), with the topical formulation completing Phase 1 and a Phase 2 epithelial study planned.

Trefoil's go-to-market and operational footprint is anchored by a cGMP manufacturing partnership with AGC Biologics (Heidelberg, Germany) for protein supply, clinical trial collaborations with Price Vision Group and the Cornea Research Foundation of America (STORM/INTREPID lead site), and a management team with over 100 years of collective ophthalmic pharmaceutical experience, including executives previously at Allergan, Santen, Genentech, and Onyx Pharmaceuticals. Customer segments upon commercialization will be fragmented across US ophthalmology providers treating FECD and corneal epithelial disorders; today, Trefoil is pre-revenue with no pricing publicly disclosed.

Name

Trefoil Therapeutics

Legal name

Trefoil Therapeutics

Website

https://trefoiltherapeutics.com

Company type

Private

Founded year

2015

Operating status

Operating

Headcount range

1–10 employees

Short description

Trefoil Therapeutics is a private, clinical-stage biotechnology company developing engineered FGF-1 (TTHX1114) therapeutics in intracameral and topical formulations for patients with Fuchs Endothelial Corneal Dystrophy and corneal epithelial disorders, headquartered in San Diego.

Ownership category

akta.pro rank

Product category

Ophthalmic Biopharmaceuticals

NAICS

Research and Development in Biotechnology (except Nanobiotechnology) (541714), Resin, Synthetic Rubber, and Artificial and Synthetic Fibers and Filaments Manufacturing (3252), Research and Development in Nanotechnology (541713)

SIC

Ophthalmic Goods (3851), Electromedical & Electrotherapeutic Apparatus (3845), In Vitro & In Vivo Diagnostic Substances (2835)

akta.pro primary industry

Ophthalmic Regeneration (cornea/retina) (HLAAAGAK)

akta.pro secondary industries

Cornea & External Disease Surgical Devices (Keratoplasty Tools, Cross-Linking Systems, Amniotic Membrane Delivery) (HLAHAJAK), Oncology Gene Therapies (incl. oncolytic vectors & gene-modified approaches) (HLAAACAF)

Keywords

• Regenerative ophthalmology therapeutics
• Corneal disease treatments
• Engineered FGF-1 therapies
• Clinical-stage biopharmaceuticals
• Ophthalmic drug development

Headquarters

HQ city

San Diego

HQ country

United States

HQ region

North America

Offices1 record

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

Technology or R&D, Personnel, Operations, Marketing or Sales, Supply Chain

Revenue model

1. Pharmaceutical Product Revenue: Pre-revenue clinical-stage biotechnology company. Anticipates generating revenue through the sale of TTHX1114 upon regulatory approval for treatment of corneal endothelial diseases (Fuchs Dystrophy) and corneal epithelial disorders.

Go-to-market motion1 record

Distribution channels1 record

Marketing channels6 records

Core offering

Trefoil Therapeutics develops TTHX1114, an engineered form of Fibroblast Growth Factor-1 (FGF1) designed to overcome the natural protein's short half-life, enabling its pharmaceutical use. The company is advancing two formulations from this single molecule: an intracameral injection for corneal endothelial diseases such as Fuchs Endothelial Corneal Dystrophy (FECD), and a topical eye drop for corneal epithelial indications including ulcers and ocular surface damage. Trefoil is a pre-revenue, clinical-stage biopharmaceutical company targeting regenerative restoration of vision.

Product overview

Trefoil Therapeutics is advancing two products based on its engineered FGF-1 molecule TTHX1114 for treating corneal diseases affecting either the epithelial (front) or endothelial (back) surface of the cornea. The intracameral injection formulation targets corneal endothelial decompensation associated with ocular surgery and Fuchs Endothelial Corneal Dystrophy (FECD), while the topical eye drop formulation addresses multiple epithelial indications with associated ocular surface damage. The company operates a clinical-stage development program with TTHX1114 currently in Phase 2 trials for the intracameral formulation and Phase 1 for the topical formulation.

Differentiator

Problem solved

Functional benefit

Products and services

• TTHX1114 Intracameral Injection An engineered form of Fibroblast Growth Factor-1 (FGF1) delivered as an intracameral injection into the anterior chamber of the eye for regenerating corneal endothelial cells in patients with Fuchs Endothelial Corneal Dystrophy (FECD) and other corneal endothelial diseases. The product stimulates cell proliferation and migration while protecting cells from stress and injury, and is intended for ophthalmologists treating corneal endothelial decompensation following ocular surgery or due to FECD.
• TTHX1114 Topical Formulation An eye drop formulation of engineered FGF-1 designed to accelerate corneal ulcer wound healing by stimulating epithelial cell growth, intended to reduce complications associated with corneal ulcers including pain, inflammation, and vision loss due to corneal scarring. Targeted at ophthalmologists treating patients with corneal epithelial defects and ulcerative conditions on the front surface of the cornea.

Quantifiable outcome

• Recovery of vision to 20/40 in mean time of 4.2 weeks following DSO and single intracameral injection of TTHX1114
• +2 more outcomes

Named customers3 records

Segments2 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

Five partnerships are on record, tiered core and minor.

• AGC BiologicscoreTechnology or Integration · 4 February 2020Manufacturing contract with AGC Biologics for cGMP manufacturing and supply of TTHX1114. AGC selected based on their proven cGMP capabilities as a manufacturer of protein-based therapeutics. Manufacturing to take place at their facility in Heidelberg, Germany.
• National Institutes of Health - NCATScoreStrategic or Co-development Partner · 3 January 2017Collaborative Research and Development Agreement (CRADA) with NIH's National Center for Advancing Translational Sciences (NCATS) under the Therapeutics for Rare and Neglected Diseases (TRND) program. NCATS researchers work with Trefoil on pre-clinical development and IND-enabling activities for TTHX1114 for treatment of Fuchs endothelial corneal dystrophy.
• E&B TechnologiesminorStrategic or Co-development Partner · 20 October 2015Collaboration with E&B Technologies for NIH R21 grant work on ocular surface injury. E&B Technologies was founded as entity to acquire innovative technologies and spin them off into operating companies. Trefoil Therapeutics is the first company formed with technology sourced by E&B Technologies.
• Florida State UniversitycoreTechnology or Integration · 24 March 2015Trefoil signed a license and research agreement with Florida State University for the development of engineered FGF-1 derivatives (eFGF-1s). The agreement gives Trefoil an exclusive license to the eFGF-1 patent estate for therapeutic and cosmetic uses. The technology was developed by Dr. Michael Blaber, Professor at FSU and co-founder of Trefoil.
• Price Vision Group / Cornea Research Foundation of AmericacoreStrategic or Co-development PartnerClinical trial site partnership for INTREPID and STORM clinical trials. Price Vision Group is the first site to initiate patient treatment and includes internationally recognized cornea specialists. Practice has conducted more cornea transplants than any other in North America.

Scale indicators4 records

Recent moves6 records

Expansion highlights5 records

Broad incumbents

• Alcon: Largest pure-play ophthalmology company globally, with surgical, pharmaceutical, and consumer vision portfolios including cataract/IOL franchises where Trefoil's DSO adjunctive therapy could fit. A potential strategic acquirer and benchmark for commercial-stage ophthalmology assets.
• Glaukos Corporation: Ophthalmic medical device and pharma company known for MIGS devices and emerging corneal health initiatives. Operates in the same ophthalmic surgery ecosystem where Trefoil's intracameral TTHX1114 would be deployed.
• Aerie Pharmaceuticals: Specialty ophthalmology pharma (now part of Alcon) focused on glaucoma, dry eye, and retinal diseases. Provides a useful comparable for small, ophthalmology-focused biotechs that reach late-stage clinical development and exit via strategic acquisition.
• Santen Pharmaceutical: Global ophthalmology-focused pharmaceutical company with a broad portfolio across front- and back-of-eye diseases. Santen is a relevant incumbent comparator in the corneal endothelial disease space and a potential strategic acquirer of Trefoil-like assets.

Direct peers

• Kala Bio: Clinical-stage ophthalmic specialty pharma developing novel therapies for rare and severe eye diseases. Comparable to Trefoil as a small, clinical-stage company pursuing differentiated mechanisms in ophthalmology indications.
• Ocular Therapeutix: Specialty ophthalmology biopharma developing drug delivery-based therapies for corneal and retinal diseases. Comparable in stage and ophthalmic focus, with a similar strategy of reformulating known mechanisms into differentiated ophthalmology products.
• Stuart Therapeutics: Clinical-stage ophthalmology company developing regenerative collagen mimetic peptides for corneal and other ocular surface diseases. Comparable to Trefoil as a small, clinical-stage biotech pursuing corneal regenerative pharmacology.
• Aurion Biotech: Clinical-stage cell therapy company developing cultivated corneal endothelial cell therapies for conditions including Fuchs Endothelial Corneal Dystrophy. Aurion is the most direct competitor to Trefoil's intracameral endothelial program, targeting the same patient population with a regenerative approach.

Emerging players

• Emmecell: Early-stage ophthalmology company developing cell-based therapies for corneal endothelial dysfunction. Direct thematic overlap with Trefoil's lead indication (FECD), though differentiated by a cell therapy rather than a protein approach.
• Cellusion: Japan-based clinical-stage regenerative medicine company developing corneal endothelial cell therapies derived from iPSCs. Overlaps with Trefoil in corneal endothelial regeneration, though it is pursuing a cell therapy rather than a recombinant protein approach.

Market position

Strengths5 records

Weaknesses4 records

Competitive moat3 records

Key risks6 records

Key highlights6 records

Customer concentration

• Facebookfacebook.com/TrefoilTherapeutics
• LinkedInlinkedin.com/company/trefoiltherapeutics

Revenue estimate

Valuation estimate

Number of profiles

Profiles6 records

Funding overview

Funding rounds7 records

Investors10 records

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M&A

Investments

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

Frequently asked questions about Trefoil Therapeutics