Lakewood-Amedex Biotherapeutics (LABT) investor relations material

Antimicrobial resistance and platform

• Antimicrobial resistance causes 4.7 million deaths worldwide; systemic antibiotics can promote resistance, while many new agents share existing drug classes and resistance profiles.

• The in-house compounds are described as a new antimicrobial class that rapidly disrupts bacterial membranes; lab experiments failed to induce resistance, while ciprofloxacin developed 2,000-fold resistance in the control experiment.

• The agents are broad-spectrum against Gram-positive, Gram-negative and multidrug-resistant bacteria, including biofilm organisms; local delivery is intended to limit systemic exposure and microbiome effects.

• Diabetic foot ulcers are the lead target: poor blood flow limits oral antibiotic delivery, and infected ulcers can progress to amputation.

Nu-3 and supporting evidence

• Nu-3 is the selected topical candidate; its gel formulation is designed to remain on wounds, and preclinical testing showed activity against resistant strains and biofilms.

• In vitro testing showed complete bacterial killing within 10 minutes at 100 mg/mL; in an animal skin-infection model, gel maintained infection reduction while solution-treated infections showed regrowth.

• In animal testing, 5% gel dosed twice daily for five days sustained activity through a further five-day observation period without treatment.

• Toxicology and wound-healing studies supported topical dosing; an early, small diabetic-foot-ulcer study found good tolerability, a pathogen-reduction trend at 2%, and reduced wound area.

Clinical program and milestones

• The ongoing Phase IIa study tests 2%, 5% and 10% gel in parallel; wound biopsies are collected at baseline, day 7 and day 14 for central bacterial counts.

• Endpoints include bacterial counts and signs of infection; wound size is secondary, with a two-week treatment period and dose-response assessment.

• Manufacturing and site enrollment were completed, and the trial started; the stated goal was to finish by year-end and report topline results in Q1 of the following year.

• If Phase IIa results are positive, the next step is a Phase IIb placebo-controlled study comparing once- and twice-daily dosing; Phase III would require international studies, partners and further manufacturing work.