We are a biotechnology company focused on leveraging unique, pioneering science to address unmet needs in the treatment of infectious diseases, improving patient outcomes, and significantly reducing the threat posed by antibiotic-resistant bacterial strains, including methicillin resistant Staphylococcus aureus (MRSA), vancomycin resistant Enterococci species (VRE), and others. Antimicrobial resistance (AMR) represents a growing global health crisis, being directly responsible for 1.27 million deaths annually and contributing to nearly 5 million deaths worldwide. The rapid rise of resistant pathogens has rendered many existing antibiotics ineffective against these pathogens, increasing the risk of severe infections, prolonged hospital stays, and substantial economic burdens. Despite this urgent need, the development of new antibiotics has slowed, with most advancements occurring within existing drug classes, leaving these new compounds vulnerable to resistance mechanisms. Our product candidates consist of antimicrobials targeting acute and chronic infectious diseases, which are delivered locally to the site of infection. As of March 2026, we hold 68 issued and 36 pending patent applications for our products and technologies, with coverage in major pharmaceutical markets. We have successfully completed our first exploratory human clinical trials for our lead product, the broad-spectrum Bisphosphocin® (anti-bacterial) Nu-3, which is being developed for the topical treatment of mildly infected diabetic foot ulcers (iDFU). We plan to conduct an initial Phase 2a safety and dose response study, followed by a placebo-controlled Phase 2b dose comparative study to identify the optimal dose for Phase 3 trials and eventual commercialization. This study will also determine the most appropriate administration regimen for Nu-3 gel formation in mildly infected diabetic foot ulcers. Additionally, we are advancing early-stage pipeline compounds and are focused on further characterizing them to identify the best clinical indications for non-clinical and clinical evaluation. Advancement of any of our product candidates to the commercialization stage is completely dependent on the outcome of clinical studies that are reviewed and approved by the FDA or other comparable regulatory authorities. Headquartered in University Park, Florida, we were originally incorporated in Delaware on July 11, 2006, under the name Nu Pharmas, Inc. (“Nu Pharmas”). We initially focused on antisense RNA research and the contract manufacturing of oligonucleotides. On April 9, 2007, Nu Pharmas acquired substantially all the assets of Renaissance Nutraceuticals, Inc., a Delaware corporation, and subsequently changed its name to Amedex Therapeutics, Inc. (“Amedex Therapeutics”). On November 11, 2007, Amedex Therapeutics acquired substantially all the assets of Lakewood Pharmaceuticals, Inc., a Delaware corporation. On February 1, 2008, Amedex Therapeutics changed its name to Lakewood-Amedex Inc. On June 5, 2025, the Company changed its name to Lakewood-Amedex Biotherapeutics Inc. and redomiciled as a Nevada corporation. Our corporate address is in University Park, Florida.
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