Lakewood-Amedex Biotherapeutics Inc., (NASDAQ: LABT, the "Company"), a clinical-stage biotechnology company advancing a novel class of potent, fast-acting, broad-spectrum antimicrobials for infectious diseases called the Bisphosphocin^® class, announced positive preclinical data in urinary tract infection (UTI) and pulmonary infection indications in animal models treated with Bisphosphocin^® compounds.

In an animal model of UTI, intravesical administration of the Bisphosphocin^® compound Nu-8 in rodents infected with E. coli resulted in up to 97% inhibition of E. coli growth with a 10% solution compared to no effect in a vehicle control group. In addition, the Bisphosphocin^® class has demonstrated in vitro activity against a broad range of resistant bacteria, including those frequently found in UTI such as E. coli, K. pneumoniae, and P. aeruginosa, and has also demonstrated activity against biofilm-forming organisms. Complicated UTIs, especially catheter-associated urinary tract infections (CAUTI), are frequently caused by drug-resistant bacteria and bacterial biofilm.

Bisphosphocin^® compounds, when administered as an aerosol formulation, have also demonstrated in vivo activity in animal models of pulmonary infections caused by Acinetobacter species, P. aeruginosa, and A. fumigatus. Additionally, the Bisphosphocin^® class has demonstrated in vitro activity against a broad range of resistant bacteria frequently found in pulmonary infections such as H. influenzae, K. pneumoniae, and P. aeruginosa.

Pulmonary infections, such as community acquired bronchial pneumonia (CABP), hospital acquired bronchial pneumonia (HABP), and ventilator acquired bronchial pneumonia (VABP), are frequently caused by drug resistant bacteria. In addition, patients with cystic fibrosis have recurrent bacterial and fungal lung infections with organisms such as P. aeruginosa and A. fumigatus.

"We continue to be encouraged by the performance of different members of the Bisphosphocin^® class of compounds when tested against various bacterial species, which are known to have a major impact on human health and are key contributors to the AMR crisis," said Kelvin Cooper, Ph.D., Chief Executive Officer and Senior Vice President of Research and Development at Lakewood-Amedex Biotherapeutics. "The Bisphosphocin^® class of compounds possesses key characteristics including rapid and potent antimicrobial action and broad-spectrum activity with no expected resistance development, which could make them valuable assets in fighting the AMR crisis. We look forward to continuing development of the various Bisphosphocin^® compounds to identify the most suitable candidate to be advanced into early clinical development."

Lakewood-Amedex Biotherapeutics' lead Bisphosphocin^® candidate, Nu-3 formulated as a topical gel, is being studied in an ongoing Phase 2a trial of mildly infected diabetic foot ulcers (iDFU), with topline data expected in the first quarter of 2027.