Recce Pharmaceuticals Ltd.

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

Phase II trial assessing the efficacy of RECCE® 327 topical gel (R327G) against acute bacterial skin and skin structure infectionsR327G demonstrating promising antibacterial effect across a broad range of human infectionsClinical study review board on track for mid-October, with interim results to followTrial study locations expand across New South Wales (NSW) and Victoria, broadening access to this potentially novel approach SYDNEY, Oct. 10, 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 15 patients in a Phase II trial evaluating RECCE® 327 topical gel (R327G) in patients with acute bacterial skin and skin structure infections (ABSSSI). ABSSSI includes diabetic foot infections (DFI) and other wound infections – areas of significant unmet medical need. “We are thrilled to pass the halfway point of this pivotal Phase II study for the unmet clinical need of topical skin infections. Indications of promising antibacterial effect are significant achievements, with patient recruitment to be completed within the year,” said James Graham, Chief Executive Officer of Recce Pharmaceuticals. “The market for ABSSSI is expanding due to an increase in the frequency of bacterial skin infections, particularly those brought on by drug-resistant strains. The acute lack of effective broad-spectrum antimicrobials contributes significantly to this challenge. With our initial data from the Therapeutic Goods Administrations (TGA) Special Access Scheme, which saw dramatic results in several DFI patients, we are excited to complete this trial and the potential of R327G to impact this growing global healthcare need.” R327G has been shown to be safe and well tolerated across subjects, indicating promising antibacterial responses in patients. These initial data represent a significant opportunity to expand the application of R327G’s formulation. ABSSSIs are a significant healthcare concern, with clinical trials addressing indications such as DFIs, necrotizing fasciitis, and post-operative wound infections. The global ABSSSI market size was estimated to be $1.34 billion in 2023 and is expected to reach $2.31 billion in the next 10 years. The Phase II 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 for ABSSSIs, designed to evaluate the efficacy and systemic absorption of R327G when applied directly to the infected area. The study is on track to enroll 30 participants by the end of 2024. In addition to the lead site, Barwon Health, the Company has added two new sites with the Australian Clinical Research Network NSW and ACRN Melbourne. 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 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

A$4.4 million of valid applications received for the Share Purchase PlanIn conjunction with recently completed A$8.0 million institutional placement, total amount raised is A$12.4 millionProceeds will be used to advance clinical trials for intravenous use of R327, topical applications of R327G, including Phase III clinical activities in Indonesia, and IND-enabling activitiesPro forma cash position of A$19.8 million SYDNEY, Aug. 06, 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 announced the successful close of its Share Purchase Plan (SPP) reported on July 2, 2024. The SPP generated significant support from Recce’s existing shareholders, and the applications received exceeded the initial SPP target of A$2.0 million. Recce received total applications for fully paid ordinary shares (Shares) of approximately A$4.4 million. In accordance with the terms of the SPP, the Board has exercised its discretion and determined to accept all valid applications in full to raise a total of A$4.4 million under the SPP. Approximately 9.9 million new Shares will be issued for A$0.45 per Share, the same issue price as the Placement. They will rank equally with existing Recce fully paid ordinary shares quoted on the ASX from their issue date. Shares under the SPP are expected to be issued on Tuesday, August 6, 2024, and quotation of the Shares is expected to commence on Wednesday, August 7, 2024. The successful completion of the SPP, in conjunction with the recently completed A$8.0 million institutional placement (Placement, together with the SPP, the Offer), takes the total funds raised under the Offer to A$12.4 million (before costs). When included with the Company’s current June 30, 2024, cash balance of $4.4 million and approximate A$3.0 million grant from the U.S. Department of Defence, Recce is well funded with a pro forma cash balance of approximately A$19.8 million. Funds raised from the Offer will be used to advance clinical trials for intravenous use of R327 and topical applications of R327G, including Phase III clinical activities in Indonesia, IND-enabling activities, working capital, and offer costs. The Board wishes to thank all new and existing shareholders who participated in the Offer. 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 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