There have been big strides forward on the clinical and corporate fronts for Recce Pharmaceuticals Ltd (ASX:RCE, OTC:RECEF) in the September quarter, with the company focused on its Phase 2 and Phase 3 clinical trials and securing funding to bolster its pipeline.
Phase 3 trial continues
Recce’s international registrational Phase 3 clinical trial for Diabetic Foot Infections (DFI) in Indonesia continues to progress, following constructive meetings with Indonesia's regulatory authority, Badan POM.
Additionally, Recce’s Phase 2 trial for Acute Bacterial Skin and Skin Structure Infections (ABSSSI), a study on its RECCE® 327 (R327G) topical gel, has reached the halfway point with 15 out of the targeted 30 participants dosed.
The trial, conducted in partnership with Australian Clinical Research Network sites, has the aim of validating the efficacy and systemic absorption of R327G in treating wound infections.
World Health Organization priority, Defense dollars
The quarter also delivered promising preclinical results from a study with Murdoch Children’s Research Institute, which demonstrated RECCE® 327’s efficacy against the multidrug-resistant pathogen *Acinetobacter baumannii*, a World Health Organization priority.
In the trial, R327 achieved a significant reduction in bacterial load, showcasing its potential to address antibiotic-resistant infections.
The US Department of Defense has awarded Recce a US$2 million (around A$3 million) grant for the continued development of R327G as a treatment for burn wound infections in military settings.
This funding will support the gel’s development, particularly to address complications from infections, including sepsis, in acute care scenarios.
Cash balance
Recce concluded the quarter with a cash balance of A$6.33 million, with an operating cash outflow of A$9.69 million that it attributed for the most part to ongoing clinical trials and preclinical activities.
Research and development expenses accounted for A$7.59 million of the total outflow, reflecting the company’s commitment to bringing its portfolio to market.
To bolster its cash position, Recce raised A$12.5 million through an oversubscribed share purchase plan (SPP) and an institutional placement.
The SPP received A$4.4 million in valid applications, exceeding its initial A$2.0 million target, while the placement contributed an additional A$8.0 million.
In the public eye
Recce was featured on the Nasdaq Tower in New York’s Times Square, spotlighting its contributions to combat antimicrobial resistance.
Also during the quarter, the company maintained ongoing engagement with the scientific community and investors, delivering the opening address at the 2024 World Antimicrobial Resistance Congress in Philadelphia.
With strengthened financial backing and robust progress across its clinical programs, Recce is positioned to advance toward further clinical milestones.
The company anticipates approvals for its Phase 3 DFI trial in Indonesia and looks to complete the Phase 2 ABSSSI study in 2025.