Lakewood-Amedex Biotherapeutics (LABT) investor relations material

Industry context and unmet need

• Antimicrobial resistance (AMR) is a global health crisis, causing over 1 million deaths annually and projected to cost $3.8 trillion in lost GDP by 2050 if unaddressed.

• Current antimicrobial development is limited, with most new drugs being incremental improvements, leading to continued resistance issues.

• Diabetic foot ulcers (DFU) represent a significant unmet need, with high infection and amputation rates due to poor efficacy of standard oral antibiotics.

Bisphosphocin class and lead candidate Nu-3

• Bisphosphocins are broad-spectrum, rapidly cidal antimicrobials with low resistance potential and activity against biofilms.

• Nu-3, the lead candidate, is formulated as a topical gel for local application, maximizing concentration at infection sites and minimizing systemic side effects.

• Preclinical studies show rapid bacterial kill and strong efficacy in animal models, with no negative impact on wound healing.

Clinical development and trial plans

• Early clinical studies demonstrated safety and positive trends in pathogen reduction and wound healing in DFU patients.

• A phase IIA trial is planned with escalating doses (2%, 5%, 10%) over 14 days, targeting first patient visit in August and readout by year-end.

• A larger phase IIb, double-blind, placebo-controlled study is planned, with phase III trials in the US and Europe to follow pending positive results.