Recce Pharmaceuticals Provides Business Update

• Promising Minimum Inhibitory Concentration (MIC) activity in Phase I/II trial for urinary tract infections (UTI) and urosepsis with an increase in dosage expected to begin in the next several weeks
• Expansion of Phase I/II trial for diabetic foot infections (DFI) with efficacy achieved and now moving towards the initiation of a Phase III registrational trial in Indonesia scheduled to commence in Q3 2024
• RECCE 327 (R327) shown to be effective against more than 300 strains of bacterial pathogens during testing with Linnaeus Bioscience
• U.S. Department of Defense has recommended RECCE 327 Gel (R327G) as a topical treatment for burn wound infections for grant funding of $2.2 million
• Submission of Investigational New Drug (IND) application with the U.S. FDA expected in H2 2024 for U.S. trial initiation in H1 2025
• Continued recognition and awareness of Recce with presentations recently presented at the Biomedical Advanced Research and Development Authority (BARDA), opening keynote address and opening R&D address at the World AMR Congress 2024 and sponsorship received from Western Australia (WA) and New South Wales (NSW) government for the BIO International Convention 2024

SYDNEY, Australia, April 10, 2024 (GLOBE NEWSWIRE) -- Recce Pharmaceuticals Ltd (ASX: RCE, FSE: R9Q) (Recce or the Company), a leading developer of a new class of synthetic anti-infectives, today provided a business update highlighting various ongoing activities and progress made since the Annual General Meeting held on November 8, 2023.

Detailed Update:

Progress of R327 across Multiple Indications
(UTI/Urosepsis, DFI, Topical Wounds, SAS-A)

Phase I/II UTI/Urosepsis Trial – R327 Achieving Minimum Inhibitory Concentration (MIC)

The Company is making significant strides in its Phase I/II trial for UTIs and urosepsis. Recent clinical urine samples have indicated promising MIC activity, suggesting that fast infusion of R327 leads to concentrations capable of blocking the growth of bacteria in urine, which is relevant for the treatment of patients with UTIs and urosepsis, in a safe and tolerable manner. This promising finding has prompted the Company to increase the dosage of R327 in this Phase I/II trial to its highest level yet, at a rate of 4,000mg infused over 30 minutes, which is expected to begin by the end of Q2 2024. This escalation reflects the significant progress surrounding R327's potential to address critical medical needs in the treatment of UTIs and urosepsis.