Lakewood-Amedex Biotherapeutics (LABT) Corporate presentation summary

Addressing antimicrobial resistance

• BisphosphocinⓇ compounds are being developed as a novel class of fast-acting antimicrobials to combat the global threat of antimicrobial resistance (AMR), which causes over 1.14 million deaths annually and could cost $3.8 trillion in lost global GDP by 2050.

• These compounds show broad-spectrum activity, including against resistant pathogens and biofilm organisms, with a low risk of resistance development.

Mechanism of action and preclinical data

• BisphosphocinⓇ compounds act by rapidly destabilizing bacterial cell membranes, causing cell death within minutes, even in resistant strains like MRSA and VRE.

• Preclinical studies show Nu-3, the lead compound, is rapidly cidal in vitro and highly effective in murine skin infection models, outperforming standard solutions in inhibiting MRSA growth.

• Multiple dosing regimens of Nu-3 gel maintain high inhibition of MRSA growth, with the 10% gel achieving over 99% inhibition.

Clinical development and strategy

• Nu-3 is being developed as a topical gel for mild infected diabetic foot ulcers (iDFU), a condition with high prevalence, poor outcomes, and significant resistance challenges.

• Phase 1 and exploratory Phase 2a studies demonstrated a favorable safety profile and promising efficacy in pathogen reduction and wound healing.

• Upcoming Phase 2a/2b trials will evaluate safety and efficacy of Nu-3 gel in iDFU, with protocols aligned with FDA guidance.

• The development pipeline includes additional programs targeting pulmonary, urinary tract, oral, and ear infections.