Recce Pharmaceuticals Receives $2 Million Grant from U.S. Department of Defense for RECCE® 327 Gel

• Funding to accelerate development of RECCE^® 327 Gel (R327G) for acute treatment of burn wound infections and downstream bacterial complications such as sepsis in a military setting
• R327G to be evaluated as a potential replacement for traditional antimicrobial dressings and topicals used in the military setting

SYDNEY, July 16, 2024 (GLOBE NEWSWIRE) — Recce Pharmaceuticals Ltd (ASX: RCE, FSE: R9Q), (Recce or the Company), the Company developing a new class of synthetic anti-infectives, today announced it has been awarded $2 million in grant funding from the U.S. Department of Defense in recognition of RECCE^® 327 Gel (R327G) as a topical treatment for burn wound infections.

“We are honored by the U.S. Department of Defense’s decision to award grant funding for R327G, as it underscores our commitment to advancing medical solutions critical to military personnel,” said James Graham, Chief Executive Officer of Recce Pharmaceuticals. “This recognition is a testament to our technology’s unique profile and high-quality R&D. We look forward to working closely with the U.S. Department of Defense to progress our research efforts and fulfill our commitment to improving global health outcomes.”

The grant funding from the U.S. Department of Defense Congressionally Directed Medical Research Programs (CDMRP) will enable the Company to accelerate the development of R327G and evaluate it as a gel-based treatment to rapidly resolve burn wound infections and minimize the onset of bacteremia complications, such as sepsis. The project aims to establish the potential for R327G products for use in a point-of-injury military setting.

The CDMRP includes the Military Burn Research Program (MBRP) Technology/Therapeutic Development Award, managed by the U.S. Department of Defense, that focuses on supporting biomedical research to advance technologies or therapies in areas of critical importance to the military and civilian populations, such as burn wound injuries.

The MBRP Technology/Therapeutic Development Award application is a specific grant designed to support projects focused on developing technologies or therapies for burn injuries, particularly those relevant to military personnel.

The Company’s application received an overall evaluation of 1.4 (Outstanding) based on a rating scale of 1 (highest merit) to 5 (lowest merit). It was assessed on three criteria, with a rating scale of 10 (highest merit) to 1 (lowest merit): research strategy and feasibility (8.2), impact and military benefit (8.8), and transition plan and regulatory strategy (9.0).

“Given their excellent preliminary data and the relatively low therapeutic index required in topical antimicrobials, it seems likely that the product would be a success,” said a scientific reviewer. A separate scientific reviewer commented on the Company’s proposal, saying, “If the proposed product is successful, it would improve the quality of life and shorten recovery and healing times for the burned individual.”

In addition to the grant, the Company has successfully completed an A$8 million institutional placement, with an opened share purchase plan (SPP) to raise up to A$2 million, available until July 31, 2024. Investors can access the share purchase plan through the ASX website under the ticker ASX: RCE, Recce’s official website at Company Announcements, or via the Automic website. This strategic financial move underscores Recce’s commitment to advancing innovative therapies and strengthening its market presence.

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 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 Contact
James Graham
Recce Pharmaceuticals Ltd
+61 (02) 9256 2571
James.graham@recce.com.au

Media & Investor Relations (AU)
Andrew Geddes
CityPR
+61 (02) 9267 4511
ageddes@citypublicrelations.com.au

Media (USA)
Michael Fitzhugh
LifeSci Communications
mfitzhugh@lifescicomms.com

Investor Relations (USA & EU)
Guillame van Renterghem
LifeSci Advisors
gvanrenterghem@lifesciadvisors.com