Lakewood-Amedex Biotherapeutics (LABT) Corporate presentation summary

AMR burden and therapeutic approach

• AMR directly causes 1.14 million deaths annually and contributes to nearly 4.7 million deaths worldwide; untreated AMR could cost ~$3.8 trillion in global GDP by 2050.

• Infections from six common multidrug-resistant pathogens cost the U.S. >$4.6 billion in 2021.

• Bisphosphocins are proposed to destabilize bacterial cell membranes, causing rapid cell death; activity is pH- and concentration-dependent and typically occurs within one minute.

• The class shows broad-spectrum activity, including against resistant pathogens, biofilm activity, low resistance-development potential, and the potential for high local drug concentrations with fewer systemic side effects.

Nu-3 preclinical evidence

• Nu-3 was selected for clinical development based on broad in vitro activity, rapid killing, biofilm activity, efficacy in skin infection models, topical gel formulation, and a favorable toxicology profile.

• In E. coli time-kill testing, 2.5% Nu-3 killed all bacteria within 10 minutes; 5% and 10% killed them within 5 minutes or less.

• In a murine MRSA skin infection model, 10% gel and solution each inhibited growth by >95% at 1 and 2 hours; gel outperformed solution at 4 hours and was far superior at 8 hours.

• In a 5-day mouse study, 5% gel given once or twice daily inhibited MRSA growth by >95%; twice-daily dosing performed better after a further 5-day recovery period.

Clinical evidence and trial plan

• A 21-day repeat patch study in 35 healthy subjects found no reaction on intact skin and minimal reaction on abraded skin with 2% Nu-3.

• In an exploratory Phase 2a study of 30 iDFU patients, Nu-3 solution was well tolerated; pathogen and ulcer-area reduction trends appeared only at 2%, prompting work on higher concentrations and a gel formulation.

• Planned Phase 2a testing in infected diabetic foot ulcers compares 2%, 5%, and 10% gel with no treatment; the Phase 2b design includes 5% and 10% gel and placebo, with CFU, infection-score, and wound-size measures.

• The stated Phase 2 objective is clinical proof of concept for safety and antimicrobial efficacy; Phase 2b treatment groups are to be confirmed after the Phase 2a readout.