Can Recce Sustain Momentum Amid Low Cash and High R&D Spend?

Recce Pharmaceuticals progresses its Phase 3 diabetic foot infection trial in Indonesia, reports promising preclinical data for inhaled RECCE 327, and secures significant R&D funding and patent protection.

  • Phase 3 clinical trial for diabetic foot infections underway in Indonesia
  • Positive preclinical efficacy of inhaled RECCE 327 against pneumonia in mice
  • Hong Kong patent granted for RECCE anti-infectives, expanding IP footprint
  • Received AUD 5.3 million R&D tax rebate with AUD 3.5 million expected
  • Awarded AusIndustry Advanced Overseas Finding for up to AUD 85 million
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Progress in Phase 3 Clinical Trial

Recce Pharmaceuticals has made significant strides in its Phase 3 clinical trial targeting diabetic foot infections (DFI) across Indonesia. The trial, one of the largest of its kind globally, aims to enrol up to 310 patients, with an interim data point expected after dosing approximately 155 patients. This study utilises the Lipsky Scale, a recognised FDA-endorsed method, to evaluate clinical response, underscoring the rigour behind the trial design. Indonesia’s high diabetes prevalence; over 20.9 million adults affected; makes this trial particularly relevant, addressing a substantial unmet medical need.

Promising Preclinical Data for Inhaled RECCE 327

Beyond the clinical trial, Recce reported encouraging preclinical results from studies on inhaled RECCE 327 (R327) against hospital and ventilator-acquired pneumonia caused by carbapenem-resistant Acinetobacter baumannii, a critical global health threat. Conducted by the Murdoch Children’s Research Institute, the study demonstrated that nebulised R327 achieved a remarkable 4-log reduction in bacterial load in mice lungs, outperforming traditional treatments like meropenem, which face solubility and side effect challenges. This positions RECCE 327 as a potentially effective and practical solution for serious lung infections.

Strengthening Intellectual Property and Regional Strategy

Recce’s intellectual property portfolio continues to expand with the granting of a patent in Hong Kong, its sixth Family 4 patent, complementing protections in Australia, Canada, Israel, Japan, and China. This strategic move supports Recce’s ambitions to penetrate ASEAN and Middle Eastern markets, regions with growing demand for innovative anti-infectives. The Hong Kong pharmaceutical market alone is valued at approximately US$2.5 billion, highlighting the commercial potential of this patent.

Financial Position and R&D Funding Boost

Financially, Recce ended the quarter with a modest cash balance of AUD 0.4 million but has since received a substantial AUD 5.3 million R&D tax rebate from the Australian Taxation Office, with an additional AUD 3.5 million expected. This non-dilutive funding supports ongoing clinical and preclinical programs. Moreover, Recce was awarded an AusIndustry Advanced Overseas Finding, confirming eligibility for up to AUD 85 million in R&D expenditure rebates over three years, including overseas activities such as the Indonesian Phase 3 trial. This finding enhances Recce’s capacity to sustain its innovation pipeline without immediate equity dilution.

Honouring Founding Vision and Looking Ahead

The announcement also paid tribute to Dr Graham Melrose, Recce’s visionary founder and inventor, whose pioneering work in polymer chemistry laid the foundation for the company’s synthetic anti-infective platform. As Recce advances its clinical programs and pursues regulatory and commercial opportunities, the company is well positioned to unlock value for shareholders amid growing global recognition of its technology.

Bottom Line?

With robust clinical progress and strengthened funding, Recce is poised for pivotal developments in infectious disease treatment.

Questions in the middle?

  • When will interim Phase 3 trial data for diabetic foot infections be released?
  • How will Recce capitalise on its expanded patent portfolio in key Asian markets?
  • What are the timelines and prospects for regulatory approvals beyond Indonesia?