RECCE-327

SYDNEY, June 12, 2024 (GLOBE NEWSWIRE) -- Recce Pharmaceuticals Ltd. (ASX:RCE, FSE:R9Q), (the Company), the Company developing a new class of synthetic anti-infectives, today announced it completed dosing an additional cohort in its Phase I/II UTI/Urosepsis trial, evaluating RECCE® 327 (R327) at fast infusion rates. "We have successfully reached a new milestone in this trial by administering a 4,000mg dose over a fast 20-minute infusion to all subjects, the highest dosage achieved so far in this trial," said James Graham, Chief Executive Officer of Recce Pharmaceuticals. “This is a significant step forward in bringing us closer to establishing R327 as a leading treatment for patients with UTIs or urosepsis." An Independent Safety Committee will review and evaluate the comprehensive data from the 6-subject cohort, with preliminary results expected in the near weeks. Data from this trial is expected to pave the way for a Phase II UTI/Urosepsis efficacy trial, potentially establishing R327 as a frontline treatment. Administering antibiotics through rapid intravenous infusions has proven to be a safe and effective method that significantly impacts patient treatment, reduces wait times, and alleviates nursing workloads worldwide.1 The complete data demonstrating the efficacy of R327 via intravenous administration will be made available at the completion of this trial in line with the study protocol. More information on this trial can be found at the Australia New Zealand Clinical Trial Registry under the trial ID ACTRN12623000448640. 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 and emerging viral pathogens. 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. Corporate Contact James Graham Recce Pharmaceuticals Ltd +61 (02) 9256 2571 James.graham@recce.com.au Media & Investor Relations (AU) Andrew Geddes CityPR +61 (02) 9267 4511 ageddes@citypublicrelations.com.au Media (USA) Michael Fitzhugh LifeSci Communications mfitzhugh@lifescicomms.com Investor Relations (USA & EU) Guillame van Renterghem LifeSci Advisors gvanrenterghem@lifesciadvisors.com 1 (21)00574-9/fulltext

First participants (male/female) dosed at 4,000mg over 20 minutes, with remaining subjects to be dosed in the near future - 4,000mg highest dosage to date in this clinical trial RECCE® 327 (R327) tested at four fast IV infusion times (15-mins, 20-mins, 30-mins, 45-mins) over various dosage levels Minimum Inhibitory Concentration (MIC) activity against bacteria already identified among existing clinical samples, a dose optimization exercise for regulatory purposes SYDNEY, Australia, May 17, 2024 (GLOBE NEWSWIRE) -- Recce Pharmaceuticals Ltd. (ASX: RCE, FSE: R9Q), (the Company), the Company developing a new class of synthetic anti-infectives, today announced it dosed the first male and female participants at 4,000mg over 20 minutes in the next cohort of a Phase I/II urinary tract infection/urosepsis trial, evaluating its lead candidate, RECCE® 327 (R327). The Company has explored multiple infusion times of R327 within this study, ranging from 15-45 minutes. 4,000mg is the highest dose tested in participants in this trial. With Minimum Inhibitory Concentration (MIC) activity against bacteria already detected in existing clinical samples, increasing dose optimization becomes a pivotal exercise for regulatory compliance. The full efficacious potential of R327 via intravenous (IV) administration will be made available at the completion of this trial in line with the study protocol. More information on this trial can be found at the Australia New Zealand Clinical Trial Registry under the trial ID ACTRN12623000448640. 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 and emerging viral pathogens. 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. Corporate Contact James Graham Recce Pharmaceuticals Ltd +61 (02) 9256 2571 James.graham@recce.com.au Media & Investor Relations (AU) Andrew Geddes CityPR +61 (02) 9267 4511 ageddes@citypublicrelations.com.au Media (USA) Michael Fitzhugh LifeSci Communications mfitzhugh@lifescicomms.com Investor Relations (USA & EU) Guillame van Renterghem LifeSci Advisors gvanrenterghem@lifesciadvisors.com