RECCE-327

Human Research Ethics Committee approval received for registrational Phase 3 trial for RECCE® 327 topical gel in patients with diabetic foot infectionsRegistrational Phase 3 clinical trial for diabetic foot infections to be conducted across Indonesia, one of the world's largest diabetes patient populationsData read-out and regulatory submission expected in late 2025 with potential approval and commercial launch in H1 2026Bilateral initiative supported by Australian and Indonesian governments with clinical support from leading Indonesian biopharmaceutical company PT Etana Biotechnologies SYDNEY, Nov. 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 received Human Research Ethics Committee approval to commence a registrational Phase 3 trial of RECCE® 327 as a topical gel (R327G) for the treatment of diabetic foot infections (DFI). Ethics approval signifies that Recce has met the safety and efficacy testing required to proceed with this large-scale, late-stage clinical trial. “Today marks the achievement of a landmark milestone in Recce’s clinical program development,” said James Graham, Chief Executive Officer of Recce Pharmaceuticals. “We are thankful for the unparalleled support from our Indonesian partners in bringing our innovative anti-infective therapy to patients in need. This welcomed approval signals the beginning of our clinical programs in Indonesia and the broader ASEAN region, bringing Recce one step closer to commercialization. We look forward to evaluating R327G in our first Phase 3 trial.” The trial will be conducted as a double-blinded, placebo-controlled study evaluating R327G for the treatment of DFIs and is on track to begin mid-December and aims to enroll up to 300 patients, with 200 to receive R327G and 100 to receive placebo. The trial will run for approximately 12 months, with an expected read-out in late 2025 and regulatory approval and commercial launch in H1 2026. The study is made possible thanks to the significant support of key Indonesian stakeholders, including the Indonesian Ministry of Health, Badan POM, PT Etana Biotechnologies, and the Australian government, accelerating R327G’s path to commercialization. The study will cost Recce around $2M before further subsiding by the Australian government’s 43.5% R&D rebate scheme under the Company’s Advanced Overseas Advanced Finding status with AusIndustry. All intellectual property is that of Recce. Indonesia’s clinical trial approval process involves two key steps: ethics approval (now approved) and BPOM (expected to follow imminently). Completing this trial would enable Recce to replicate regulatory approval for R327G across the broader ASEAN region, including Malaysia, the Philippines, Singapore, and Thailand, as a treatment for DFIs, addressing a critical unmet need for new therapeutics in countries facing increasing rates of antimicrobial resistance and infectious diseases. The trial will be initially conducted at PT Siloam International Hospitals, the largest private hospital network that provides health service facilities in hospitals and clinics in various cities across Indonesia. This approval to commence dosing the registrational Phase 3 trial in DFIs follows a 100% patient response rate in an ongoing Phase 2 study for acute bacterial skin and skin structure infections (ABSSSI) in Australia, showing all patient infections were cured/improved with R327G treatment. The risk of a person with diabetes developing a foot ulcer has been estimated to be as high as 34%.1 Approximately 50% of all diabetic foot ulcers develop infection, which can lead to sepsis, gangrene, amputation, and death.2 The DFI treatment market is estimated to be worth ~$5.2 billion.3 Initially targeting the Indonesian market, which is anticipated to be worth ~$189 million, where diabetes impacts 11% of the population each year.4 Indonesian approvals would provide access to the broader Asia Pacific market worth ~$1.0 billion annually.5 About Recce Pharmaceuticals LtdRecce 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 ContactJames GrahamRecce Pharmaceuticals Ltd+61 (02) 9256 2571James.graham@recce.com.au Media & Investor Relations (AU)Andrew GeddesSeed Media+61 (02) 9267 4511andrew@seedmedia.com.au Media (USA)Michael FitzhughLifeSci Communicationsmfitzhugh@lifescicomms.com Investor Relations (USA & EU)Guillame van RenterghemLifeSci Advisorsgvanrenterghem@lifesciadvisors.com 1 The Diabetic Foot NCBI2 Up to Date Evaluation of the diabetic foot3 Grand View Research, Diabetic Foot Ulcer Treatment Market Size, 20234 Diabetes Atlas, International Diabetic Federation and Prof EM Yunir, Faculty of Medicines, University of Indonesia5 Business Market Insights, Asia Pacific Diabetic Foot Ulcer Market, 2021

RECCE® 327 Topical Gel (R327G) was demonstrated to be safe and well-tolerated in patients – R327G demonstrating highly encouraging efficacy results as determined by non-Data Safety Monitoring BoardAll patients completing treatment with R327G met the primary endpoint of complete cure or improvement, seen as early as 7 daysNo Serious Adverse Events noted in patients - recommendation for clinical trial to continue, reflecting promising potential of R327G as a safe and effective treatment for acute bacterial skin and skin structure infections, including diabetic foot infections SYDNEY, Oct. 31, 2024 (GLOBE NEWSWIRE) -- Recce Pharmaceuticals Ltd (ASX:RCE, FSE:R9Q), (the Company), the Company developing a new class of synthetic anti-infectives, today announced that an independent non-Data Safety Monitoring Board (non-DSMB) has completed its review of safety and efficacy data from the Company’s ongoing Phase II clinical trial of its lead compound, RECCE® 327 Gel (R327G), in patients with acute bacterial skin and skin structure infections (ABSSSI), including diabetic foot infections (DFI). "We're seeing some very promising results from the interim data in the Phase II trial, which confirm the safety and potential efficacy of R327G in treating ABSSSI, including diabetic foot infections”, said Professor Eugene Athan, Coordinating Principal Investigator of the study. James Graham, Chief Executive Officer of Recce Pharmaceuticals, added, “We are extremely encouraged by the feedback from the non-Data Safety Monitoring Board and the profile of R327G. The absence of serious adverse events, coupled with the wide range of broad-spectrum efficacy across challenging wound infections, reinforces the potential of R327G to address unmet medical needs in the treatment of serious bacterial infections.” The non-DSMB found no safety concerns and unanimously recommended continuing the clinical trial, which is expected to be completed by the end of the year. This decision was based on R327G’s excellent safety profile, with no serious adverse events (SAE) observed in patients and highly encouraging efficacy results. The majority of patients treated with R327G demonstrated highly encouraging efficacy results, with all patients meeting the primary endpoint and achieving either complete cure or improvement, in some cases in as little as 7 days. These outcomes were measured using the Lipsky Clinical Resolution of Infection Scale (Lipsky Scale), a widely recognized tool for assessing the resolution of infections, particularly in diabetic foot infections. The non-DSMB's positive findings further underscore the strong safety profile of Recce’s innovative anti-infective therapy. The conditions treated included diabetic foot ulcer, eczema, scratches, and puncture wound infections. A wide variety of infecting bacteria (Gram positive and Gram negative) were isolated and successfully treated with improvement/cure of infection in all patients that continued with their treatment. Patient ID Age/Gender Infection Clinical Response Patient 188/MaleABSSSICure (Day 7)Patient 253/MaleABSSSICure (Day 7)Patient 349/MaleABSSSICure (Day 7)Patient 463/FemaleABSSSICure (Day 7)Patient 546/MaleABSSSICure (Day 14)Patient 663/FemaleABSSSICure (Day 14)Patient 767/MaleABSSSIImprovement (Day 7)Patient 872/MaleABSSSIImprovement (Day 7)Patient 970/MaleABSSSIImprovement (Day 7)Patient 1059/MaleABSSSIImprovement (Day 7)Patient 1163/MaleABSSSIImprovement (Day 7)Patient 1268/MaleABSSSIImprovement (Day 14)Patient 1381/FemaleABSSSIWithdrawn*Patient 1484/FemaleABSSSIImprovement (Day 14) *While no serious adverse events were noted, one patient was discontinued due to pain at the wound site, which was judged to be unlikely related to R327G. The Global ABSSSI treatment market size was valued at $7.3B USD in 2018 and is projected to reach $26B USD by 2032, representing a CAGR of 9.5% between 2019 and 2032. The title of the Phase II clinical trial is an “Open-label, Pilot Efficacy Study and Exploratory Evaluation of the Systemic Bioavailability of Single and/or Multiple Doses of R327 as a Topical Gel Applied to Acute Bacterial Skin and Skin Structure Infections” (Trial ID ACTRN12624000973516) and is designed to evaluate the efficacy and systemic absorption of R327G when applied directly to the infected area. More information on this trial can be found at the Australia New Zealand Clinical Trial Registry under the trial ID ACTRN12624000973516. 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 utilized 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, recognizing 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 ContactJames GrahamRecce Pharmaceuticals Ltd+61 (02) 9256 2571James.graham@recce.com.au Media & Investor Relations (AU)Andrew GeddesCityPR+61 (02) 9267 4511ageddes@citypublicrelations.com.au Media (USA)Michael FitzhughLifeSci Communicationsmfitzhugh@lifescicomms.com Investor Relations (USA & EU)Guillame van RenterghemLifeSci Advisorsgvanrenterghem@lifesciadvisors.com