What Recce Pharmaceuticals does

Recce Pharmaceuticals Ltd (ASX: RCE) is an Australian clinical-stage biopharmaceutical company founded in 2008 and headquartered in Sydney. It is developing RECCE® 327 Topical Gel, a synthetic polymer-based broad-spectrum anti-infective designed to treat diabetic foot infections (DFI). The product is administered as a topical gel and is positioned against a therapeutic area with limited effective options, particularly for moderate infections and infected ulcers below the knee.

The company's underlying technology is a proprietary polymer-antibiotic platform anchored by a single lead asset, RECCE® 327. Following HREC approval in 2026, the asset advanced into pivotal Phase 3 registrational trials. Recce is running two parallel registrational Phase 3 studies — one in Australia and one in Indonesia — with full enrollment targeted by the end of 2027. The Phase 3 protocol was expanded from mild-only infections to include moderate infections, increasing the addressable patient population to approximately 80% of DFI presentations. The company is pursuing multi-jurisdiction registration across Australia, the United States, MENA, and ASEAN.

Recce Pharmaceuticals is pre-revenue and currently generates no product sales. Its business model is to develop and ultimately commercialize RECCE® 327 Topical Gel through traditional pharmaceutical distribution channels — hospital pharmacies, specialty pharmacies, and healthcare provider networks — supported by a field sales organization targeting hospital systems, wound care clinics, and diabetic foot treatment specialists post-approval. Until then, the company is funded primarily through periodic equity raises (with disclosed tranches of roughly AUD 20.0M in 2020, AUD 8.0M in 2023, AUD 2.0M in 2024 including U.S. Department of Defense support, and AUD 3.1M in 2025) and is led by CEO James Graham, CSO/Executive Director Michele Dilizia, and VP Translational Sciences Philip Sutton.

Name

Recce Pharmaceuticals

Legal name

Recce Pharmaceuticals Ltd

Website

https://recce.com.au

Company type

Public

Founded year

2008

Operating status

Operating

Headcount range

11–50 employees

Short description

Recce Pharmaceuticals is an Australian clinical-stage biopharmaceutical company (ASX: RCE) developing RECCE® 327 Topical Gel, a synthetic polymer antibiotic for diabetic foot infections, currently advancing through parallel registrational Phase 3 trials in Australia and Indonesia.

Ownership category

akta.pro rank

Product category

Anti-infective pharmaceuticals

NAICS

Pharmaceutical and Medicine Manufacturing (3254)

SIC

Biological Products, (No Disgnostic Substances) (2836)

akta.pro primary industry

Skin Substitutes & Biologic/Regenerative Wound Therapies (Matrices, Grafts) (HLAHALAE)

Keywords

• Synthetic polymer antibiotics
• Anti-infective pharmaceuticals
• Topical antibiotic gel
• Diabetic foot infections
• Broad-spectrum antibiotics

Headquarters

HQ city

Sydney

HQ country

Australia

HQ region

Oceania

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

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

Revenue model

1. RECCE® 327 Topical Gel commercialization: Recce Pharmaceuticals is a clinical-stage biopharmaceutical company developing novel anti-infective drugs. Revenue will be generated through the sale of approved pharmaceutical products, specifically RECCE® 327 Topical Gel upon regulatory approval and commercialization across targeted markets including Australia, United States, MENA, and ASEAN regions.

Go-to-market motion1 record

Core offering

Recce Pharmaceuticals develops RECCE® 327 Topical Gel, a novel synthetic polymer-based broad-spectrum anti-infective drug candidate formulated for the topical treatment of diabetic foot infections (DFI). The product is currently in two parallel registrational Phase 3 clinical trials in Australia and Indonesia, with an expanded protocol covering mild to moderate infections and infected ulcers below the knee, addressing approximately 80% of DFI presentations.

Product overview

Recce Pharmaceuticals is a clinical-stage biopharmaceutical company developing RECCE® 327 Topical Gel, a novel anti-infective drug candidate for diabetic foot infections. The company is currently conducting two parallel registrational Phase 3 clinical trials in Australia and Indonesia, targeting global registration across Australia, the United States, MENA, and ASEAN markets. The product is a single topical gel formulation.

Differentiator

Problem solved

Functional benefit

Brands

• RECCE® 327: RECCE® 327 Topical Gel - Company's lead anti-infective drug candidate for diabetic foot infections

Products and services

• RECCE® 327 Topical Gel

Segments1 record

Ideal customer profiles1 record

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature1 record

Scale indicators3 records

Recent moves6 records

Expansion highlights5 records

Direct peers

• PolyPid: PolyPid is a clinical-stage biopharmaceutical company developing polymer-based drug delivery and anti-infective therapeutics; highly comparable on technology platform (polymer-based anti-infective) and clinical-stage structure targeting surgical-site and similar infection indications.
• Spero Therapeutics: Spero Therapeutics is a clinical-stage antibiotics developer focused on novel mechanisms to address resistant bacterial infections, including topical anti-infective candidates; directly comparable as a small-cap anti-infective specialist pursuing regulatory approval in similar indications.
• ContraFect Corporation: ContraFect is a clinical-stage biotech developing direct lytic and other novel anti-infective agents targeting serious bacterial infections; comparable on business model (clinical-stage anti-infectives) and category (novel-mechanism antibiotics).
• Organogenesis Holdings: Organogenesis is a wound care and regenerative medicine company marketing advanced wound care products for chronic wounds including diabetic foot ulcers; comparable on target indication (DFU/DFI) and topical/wound care commercial model.
• MiMedx Group: MiMedx develops and commercializes regenerative wound care and surgical products for chronic wounds including diabetic foot ulcers; comparable on target indication and wound care specialty pharmacy/channel strategy.
• Destiny Pharma: Destiny Pharma developed XF-73, a topical antimicrobial gel targeting infection-related indications including surgical site infections; closely comparable as a small-cap clinical-stage anti-infective developer with a topical gel asset.

Broad incumbents

• Smith & Nephew: Smith & Nephew is a large diversified medical device company with a major advanced wound care franchise serving diabetic foot ulcer and wound infection markets; comparable as a competing commercial player in the same DFI/wound care category.
• Integra LifeSciences: Integra LifeSciences has a dedicated wound care portfolio including regenerative skin substitutes and topical solutions for diabetic foot ulcers and complex wounds; comparable as a wound care incumbent and potential M&A consolidator of DFI therapies.
• Coloplast: Coloplast operates a global wound and skin care business including wound dressings and products for diabetic foot ulcers; comparable as an established wound care incumbent addressing the same patient population.
• Convatec Group: Convatec is a global wound care, ostomy, and continence company with established products for diabetic foot ulcers and wound infections; comparable as an established wound care incumbent in the same target indication.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat3 records

Key risks5 records

Key highlights5 records

Customer concentration

• Xx.com/ReccePharma

Revenue estimate

Valuation estimate

Number of profiles

Profiles3 records

Funding overview

Funding rounds5 records

Investors1 record

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 Recce Pharmaceuticals