Recce Pharmaceuticals Secures $5.3M R&D Rebate and Advances U.S. Army Burn Wound Research
Recce Pharmaceuticals bolsters its clinical and commercial pipeline with a $5.3 million AUD R&D tax rebate, a second U.S. Army research agreement for its RECCE 327 Gel, and a key patent granted in Brazil, while progressing Phase 3 trials in Indonesia.
- Received $5.3 million AUD R&D tax rebate for FY2025
- Second CRADA signed with U.S. Army Institute of Surgical Research
- Brazil patent granted protecting anti-infectives until 2041
- Phase 3 diabetic foot infection trial dosing ongoing in Indonesia
- Cash balance stands at $1.7 million AUD with $3.5 million AUD rebate expected
Strategic U.S. Army Collaboration Expands Burn Wound Research
Recce Pharmaceuticals (ASX:RCE) has deepened its ties with the U.S. military by signing a second Cooperative Research and Development Agreement (CRADA) with the U.S. Army Institute of Surgical Research (USAISR) to evaluate its RECCE 327 Gel (R327G) for burn wound infections. This latest agreement tasks USAISR, a leader in combat casualty and burn care research based in Texas, with testing R327G in a validated rat model that mimics battlefield burn injuries and infections, focusing on stubborn pathogens like MRSA and Pseudomonas aeruginosa.
R327G is positioned as a next-generation amorphous gel wound dressing designed for frontline military use and broader clinical applications. Its standout features include sustained efficacy upon repeated use and a low risk of bacterial resistance development. Although this CRADA does not include direct funding or milestone payments, it offers Recce access to world-class military research facilities, potentially paving the way for regulatory submissions and commercialisation of R327G in burn care and trauma infection management.
This agreement builds on Recce's earlier CRADA with the U.S. Army Medical Research Institute of Infectious Diseases and complements a USD $2 million grant from the Congressionally Directed Medical Research Program (CDMRP), underscoring growing U.S. government interest in Recce's anti-infective technology. The strategic significance of this collaboration was highlighted in Recce’s recent second U.S. Army research agreement announcement.
Patent Protection Strengthened in Brazil’s Antibiotics Market
Recce has secured a critical patent grant from the Brazilian National Institute of Industrial Property for its Family 4 patent portfolio covering RECCE anti-infectives, including R327 and RECCE 529. This patent, valid until 2041, protects the preparation processes and therapeutic uses of these compounds across a broad range of bacterial and viral infections, including skin infections, diabetic foot infections, burn wounds, respiratory infections, and sexually transmitted diseases. The patent also covers multiple administration routes such as oral, inhalation, topical gels, and injections.
Brazil represents one of the largest and fastest-growing antibiotic markets in South America, with revenues expected to surpass AUD $1.36 billion by 2033. This patent grant bolsters Recce’s intellectual property coverage in a key commercial territory, complementing its existing patents in Australia, Canada, China, Japan, and several other jurisdictions. This milestone was previously noted in Recce’s Brazil patent milestone coverage.
Phase 3 Clinical Trial Progress in Indonesia
Recce continues to advance its registrational Phase 3 clinical trial for diabetic foot infections (DFI) across five active clinical sites in Indonesia. Patient dosing is underway with a target enrolment of 310 participants randomized to receive either R327G or placebo. An interim data readout is expected after 155 patients have been dosed, which could trigger an accelerated approval submission and a potential commercial launch in 2026.
This trial is a cornerstone of Recce’s strategy to address a significant unmet medical need in a large and growing market, supported by recent regulatory clearances and site activations. The trial’s steady progress and regulatory positioning were detailed in the company’s Phase 3 trial progress in Indonesia update.
Financial Position Supported by R&D Tax Incentives
Recce ended the quarter with a cash balance of AUD $1.7 million, bolstered by a AUD $5.3 million R&D tax incentive rebate received from the Australian Taxation Office for FY2025. The company expects an additional AUD $3.5 million rebate shortly, which will provide meaningful non-dilutive funding to support ongoing clinical trials and preclinical development.
Operating cash inflows of AUD $1.6 million this quarter were driven by R&D activities, with expenditures focused on advancing clinical programs. The company also maintains access to standby equity capital of approximately AUD $2 million under an At-the-Market subscription agreement, alongside loan facilities totaling AUD $11.6 million drawn to date. These financial resources underpin Recce’s ability to sustain its development pipeline and pursue licensing negotiations for its late-stage assets.
The company’s recent financial disclosures and operational updates reflect a disciplined approach to funding growth while advancing multiple value-driving programs in parallel.
Bottom Line?
Recce’s expanding U.S. military collaborations, patent portfolio in key markets, and advancing Phase 3 trial position it well, but clinical and regulatory milestones in 2026 will be pivotal for commercial momentum.
Questions in the middle?
- Will interim Phase 3 data from Indonesia support accelerated regulatory approval in 2026?
- How might positive outcomes from the USAISR burn wound infection model impact Recce’s commercial partnerships?
- What progress can be expected from ongoing licensing negotiations for Recce’s late-stage clinical assets?
