Communicators

Sydney Australia, 26 February 2025: Recce Pharmaceuticals Limited (ASX:RCE, FSE:R9Q), (Recce or the Company) the Company developing a New Class of Synthetic Anti-Infectives, is pleased to announce the receipt of a notice of allowance from the Japan Patent Office for Patent Family 4 for Recce’s Anti-infectives, expiry 2041.

The Japan Patent claims relate to RECCE® 327 (R327) and RECCE® 529 (R529), most notably:

-          Process for preparation of RECCE® anti-infectives

-          Use of R327/R529 for the treatment of disease, particularly in treatment of bacterial infections, viral infections and more

• Specifically, further validating RECCE® anti-infectives from studies in Acute bacterial skin and skin structure infections (ABSSSI), Diabetic Foot Infections (DFI), Burn Wounds, Lung Infections (including Ventilator-associated pneumonia/Hospital-acquired pneumonia), Urinary Tract Infections, Gonorrhoea, Influenza, SARS-CoV2

-          Administration by oral, inhalation, transdermal delivery or by injection (into the bloodstream, intramuscular and/or intravenous)

-          Administration may also be applied as an aerosol, gel, topical foam or ointment (or impregnated into a dressing for application to skin or mucous membranes for transdermal or transmucosal delivery)

This is the fourth Family 4 patent, alongside Australia, Canada and Israel, with further Patent Cooperation Treaty Country (PCT) submissions in respective stages of review/allowed.

Japan is the third largest pharmaceutical market in the world[i], with a share of approximately 5% of the global pharmaceutical market.[ii] The antibiotic resistance market in Japan is expected to reach a projected revenue of US$ 411.3 million by 2030. A compound annual growth rate of 6.1% is expected of the Japanese antibiotic resistance market from 2024 to 2030.[iii]

Recce Pharmaceuticals’ Chief Executive Officer, James Graham said: “We are encouraged by the Japan Patent Office’s formal recognition of Recce’s New Class of Anti-Infectives. Global patent protection underscores our commitment to addressing critical unmet medical needs with innovative therapies. We are well-positioned to deliver meaningful solutions for patients worldwide.”

This announcement has been approved for release by Recce Pharmaceuticals Board.

About Recce Pharmaceuticals Ltd

Recce Pharmaceuticals Ltd (ASX: RCE, FSE: R9Q) is developing a New Class of Synthetic Anti-Infectives designed to address the urgent global health problems of antibiotic-resistant superbugs.

Recce’s anti-infective pipeline includes three patented, broad-spectrum, synthetic polymer anti-infectives: RECCE® 327 (R327) as an intravenous and topical therapy that is being developed for the treatment of serious and potentially life-threatening infections due to Gram-positive and Gram-negative bacteria, including their superbug forms; RECCE® 435 (R435) as an orally administered therapy for bacterial infections; and RECCE® 529 (R529) for viral infections. Through their multi-layered mechanisms of action, Recce’s anti-infectives have the potential to overcome the processes utilised by bacteria and viruses to overcome resistance – a current challenge facing existing antibiotics.

The World Health Organization (WHO) added R327, R435, and R529 to its list of antibacterial products in clinical development for priority pathogens, recognising Recce’s efforts to combat antimicrobial resistance. The FDA granted R327 Qualified Infectious Disease Product designation under the Generating Antibiotic Initiatives Now (GAIN) Act, providing Fast Track Designation and 10 years of market exclusivity post approval. R327 is also included on The Pew Charitable Trusts’ Global New Antibiotics in Development Pipeline as the sole synthetic polymer and sepsis drug candidate in development.

Recce wholly owns its automated manufacturing, supporting current clinical trials. Recce’s anti-infective pipeline aims to address synergistic, unmet medical needs by leveraging its unique technologies.

[i] https://www.trade.gov/country-commercial-guides/japan-pharmaceuticals

[ii] https://www.statista.com/statistics/275535/distribution-of-global-pharmaceutical-market-revenue/

[iii] https://www.grandviewresearch.com/horizon/outlook/antibiotic-resistance-market/japan