Recce Pharmaceuticals (RCE) AGM 2026 presentation summary

Clinical pipeline and trials

• R327G is being tested in dual Phase 3 diabetic foot infection trials in Indonesia and Australia, with the program targeting potential registrations in Indonesia, ASEAN, Australia and the US.

• Indonesia trial: 90 patients enrolled, 75-patient dataset submitted for independent unblinded DMC review, and recruitment at 4.5 patients per week; planned interim analysis at 155 of 310 patients.

• Blinded review of Indonesian data indicated strong efficacy across the study population and an excellent safety and tolerability profile; potential regulatory submission depends on DMC recommendation, trial results and BPOM review.

• Australia trial: 208 participants, interim analysis after 104; HREC-approved amendment adds mild and moderate DFI and head-to-head comparison with existing antibiotics, with dosing continuing.

• R327 IV completed Phase I with a safe, well-tolerated profile; inhaled and burn-wound programs include preclinical and planned Phase I/II work.

Commercial and licensing

• Binding exclusive Arrotex licence covers R327G for DFI and ABSSSI in Australia and NZ; Arrotex funds commercialisation, while the product retains its IP and supply role and receives a quarterly gross-margin profit share.

• Non-binding MENA term sheet proposes a 10-year exclusive licence across KSA, GCC countries, Iraq, Egypt, Algeria and Morocco, with US$1,500 per treatment or pricing agreed with the KSA regulator.

• Proposed MENA economics include 30% of net selling price plus a 6% annual royalty on net sales above US$50m; Saudi marketing authorisation may require no additional trials conditional on positive Indonesian Phase 3 results.

• Illustrative combined DFI market estimate: 2,052,300 mild or moderate cases per year and A$4.37b potential market; pricing and uptake assumptions are not forecasts of sales or market share.

Strategic position and development support

• RECCE 327 has FDA QIDP designation; if approved in the US, it is eligible for fast-track designation and priority review and could receive an additional five years of market exclusivity; it is on WHO’s List of Antibacterial Products in Clinical Development.

• US government collaborations include a US$2m CDMRP grant for burn-wound research and CRADAs with USAMRIID and USAISR; the CRADAs do not provide direct funding.

• The stated US medical countermeasures strategy earmarks US$4.46b for broad-spectrum antimicrobials; no application for or award under that strategy was reported.

• Patent portfolio comprises over 40 patents and applications across major markets, covering manufacturing, treatment of infections and viral infections, and biologically active copolymers.

• The presentation identifies R327G as the only anti-infective in Phase 3 among ASX-listed companies, based on information available as of 6 November 2026.