Bench2Bedside:
Lakewood-Amedex Biotherapeutics recently completed a direct listing on Nasdaq under the ticker LABT. Why is this an important milestone for the company?

Kelvin Cooper, Ph.D., CEO of Lakewood-Amedex Biotherapeutics, Inc.:
Completing our direct listing on Nasdaq is a defining milestone for Lakewood-Amedex Biotherapeutics. It gives us a public market platform at a time when we believe the company is entering an important stage of growth, both clinically and strategically.

Our focus is on advancing a novel class of antimicrobials known as Bisphosphocins®, which we believe have the potential to address major unmet needs in infectious disease, particularly where antimicrobial resistance is making current treatment options less effective. With Nasdaq visibility, we are better positioned to communicate our story to investors, partners, clinicians and other stakeholders as we advance Nu-3, our lead candidate for iDFU, and continue to build the broader potential of our platform.

B2B: What makes the Bisphosphocin® platform potentially differentiated?

Cooper: The platform is designed around rapid, broad-spectrum antimicrobial activity. Bisphosphocin® compounds target bacterial cell membranes and have demonstrated activity against gram-positive, gram-negative and resistant pathogens, including MRSA and VRE. This is not just another antibiotic; Bisphosphocin® compounds represent an entirely new class with a unique mechanism of action and are designed for local drug delivery, which we believe can be highly effective at rapidly killing resistant pathogens. Importantly, the class has shown in initial in-vitro testings the potential for very low resistance development, which would be a critical differentiator in infectious disease.

We believe this combination — rapid killing, broad activity, local delivery and low expected resistance — creates a compelling foundation for product development.

B2B: Why is Nu-3 initially focused on iDFU?

Cooper: iDFUs represent an enormous and underserved market with serious consequences for patients. Globally, approximately 830 million people have diabetes, and about one-third develop a diabetic foot ulcer during their lifetime. Roughly half of those ulcers become infected at some point and often multiple times.

Nu-3 is well suited for this indication because it is being developed as a topical gel that can be applied directly to the site of infection. That matters because many diabetic patients have poor circulation, which can limit the effectiveness of systemic therapies in reaching the wound at sufficiently high enough concentrations. Local delivery also has the potential to reduce systemic exposure and related side effects.

B2B: What is the development plan for Nu-3?

Cooper: We are advancing Nu-3 through a structured Phase 2 clinical program designed to establish proof of concept, optimize dose selection, and position the program for a potential registration-enabling pathway.

The program is expected to begin with a Phase 2a study evaluating three gel concentrations — 2%, 5% and 10% — to generate initial clinical proof of concept in patients with mildly infected DFUs. Based on those results, we plan to advance into a Phase 2b study evaluating different gel concentrations administered either once daily or twice daily compared to placebo.

B2B: You recently announced antimicrobial resistance data for Nu-3. Why are those findings important?

Cooper: The data are highly encouraging because they support one of the central ideas behind our platform: that Bisphosphocins® may be less prone to resistance development than conventional antibiotics.

In 21-day serial passage studies with E. coli and MRSA, Nu-3 showed only a slight MIC increase for E. coli and no MIC change for MRSA. By comparison, the ciprofloxacin control MIC increased more than 2,000-fold for E. coli and more than 600-fold for MRSA. Nu-3 also maintained its original MIC against bacteria that had developed resistance to ciprofloxacin, suggesting no cross-resistance in those experiments.

This is important not only for iDFU but also for the broader potential of the Bisphosphocin® class in addressing antimicrobial resistance

B2B: How does Lakewood-Amedex Biotherapeutics fit into the larger fight against antimicrobial resistance?

Cooper: Antimicrobial resistance is one of the most urgent public health challenges in the world, responsible for millions of deaths annually. This represents a global and a societal challenge requiring innovation and novel approaches, like the Bisphosphocin® class offers.

Our mission is to develop antimicrobials that can help address this crisis. Nu-3 gives us an important first opportunity in iDFU, but the broader platform may allow us to pursue additional serious infections where resistance is a growing concern, such as Catheter Associated Urinary Tract Infection (CAUTI) and pulmonary infections.. We believe that is where Lakewood-Amedex Biotherapeutics has the potential to create meaningful value — by advancing a new class of antimicrobials at a time when new approaches are urgently needed.

B2B: What should investors watch for next?

Cooper: Investors should watch our progress with Nu-3 as we move through Phase 2 development in iDFU ulcers and generate clinical data that can support advancement toward later-stage trials.

The Nasdaq listing provides us with a strong public company platform. Now the focus is execution: advancing Nu-3, generating clinical evidence and demonstrating the broader value of our differentiated antimicrobial platform.