Communicators

Highlights:

-          Cooperative Research and Development Agreement (CRADA) with the United States Army Medical Research Institute of Infectious Diseases (USAMRIID), the United States’ Leading BSL-4 Biodefense Laboratory

-          RECCE® 327 (R327) to be tested against highly hazardous pathogens of biodefense concern in USAMRIID in vitro infection models under high biocontainment conditions

-          CRADA is supported and funded by the Defense Threat Reduction Agency

-          Agreement to support ongoing US Department of Defense initiatives including recently awarded US$2 million grant for burn wound program

Sydney Australia, 28 April 2025: Recce Pharmaceuticals Limited (ASX:RCE, FSE:R9Q), (Recce or the Company), the Company developing a New Class of Synthetic Anti-Infectives, is pleased to announce that it has entered into a Cooperative Research and Development Agreement (CRADA) with the United States Army Medical Research Institute of Infectious Diseases (USAMRIID), with partnership and funding from the Defense Threat Reduction Agency.

USAMRIID will test Recce’s synthetic anti-infective RECCE® 327 (R327) against a panel of biodefence pathogens in USAMRIID’s established in vitro infection models. Upon successful testing, the next phase of evaluation may progress to small animal model testing.

USAMRIID is the United States Army’s premier institution and facility for defensive research into countermeasures against biological warfare. The Institute is the only laboratory in the U.S. Department of Defense (DOD) equipped to safely study highly hazardous pathogens requiring maximum containment at Biosafety Level 4.

USAMRIID’s biodefense testing partnership is in addition, and runs parallel to, a recently awarded US$2M burn wound grant by the U.S. Department of Defense Congressionally Directed Medical Research Program (CDMRP) seeking to accelerate the development of R327G and evaluate it as a gel-based treatment to rapidly resolve burn wound infections.

Chief Executive Officer James Graham said, “We are thrilled to enter into another U.S. Department of Defense Research program, this time with the United States Army Medical Research Institute of Infectious Diseases and are very thankful for our partners at USAMRIID and DTRA. This program will see the U.S. Army test R327 against some of the world’s deadliest pathogens and comes in addition to an ongoing DoD burn wound program, further bolstering Recce’s on-going U.S. Government partnerships.”

About RECCE® 327

Designed as a synthetic anti-infective, R327 is broad-spectrum, shown to be effective against both Gram-positive and Gram-negative bacteria, including drug-resistant superbugs. R327’s unique mechanism of action has allowed it to demonstrate consistent bacterial kill across multiple strains, with no loss of efficacy over repeated use and so signs of resistance. R327 has been well-tolerated in human clinical trials via both intravenous and topical administration and has shown strong safety and efficacy profiles in a range of pre-clinical and clinical studies.

Background

Antibiotic resistance is an increasing problem with serious health consequences for both military and civilian populations. U.S. Government agencies, including the Defense Threat Reduction Agency Joint Science and Technology Office within the DoD and the Biomedical Advanced Research and Development Authority within the U.S. Department of Health and Human Services, have developed programs to partner with non-federal research organisations in the private and public sectors to accelerate the development of new therapeutic compounds having broad spectrum antibacterial activity.

This announcement has been approved for release by Recce Pharmaceuticals Board.

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.

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.

About USAMRIID

Since 1969, USAMRIID has provided leading edge medical capabilities to deter and defend against current and emerging biological threat agents. The Institute is the only laboratory in the Department of Defense equipped to safely study highly hazardous viruses requiring maximum containment at Biosafety Level 4. Research conducted at USAMRIID leads to vaccines, drugs, diagnostics, and training programs that protect both Warfighters and civilians. The Institute's unique science and technology base serves not only to address current threats to our Armed Forces but is an essential element in the medical response to any future biological threats that may confront our nation. For more information, visit: https://usamriid.health.mil/.

The information contained in this press release does not necessarily reflect the position or the policy of the U.S. Government and no official endorsement should be inferred.