Lakewood-Amedex Hits Nasdaq to Fight Superbugs in Diabetic Wounds

SARASOTA, Fla. – April 23, 2026 – Clinical-stage biotechnology company Lakewood-Amedex Biotherapeutics began a new chapter in its fight against infectious diseases today, as its shares commenced trading on the Nasdaq Capital Market under the ticker symbol "LABT". The move, executed as a direct listing, positions the company to accelerate the development of its novel class of antimicrobials aimed at one of modern medicine's most persistent threats: antibiotic-resistant bacteria.

At the forefront of this effort is the company's lead candidate, Nu-3, a topical treatment being developed for infected diabetic foot ulcers (iDFU), a severe and growing complication for millions of patients worldwide.

A New Chapter on Nasdaq

Lakewood-Amedex's arrival on the public market is a significant milestone, providing the visibility and financial flexibility needed to advance its ambitious clinical programs. The company opted for a direct listing, a path that allows existing shareholders to sell their shares directly to the public without the company issuing new equity in a traditional initial public offering (IPO). While Lakewood-Amedex will not receive proceeds from the sale of these registered shares, the company has secured capital through other means. In conjunction with the listing, it arranged a $7.5 million private placement of Series C Preferred Stock, signaling confidence from its investor base.

"This listing is a notable achievement marking a new chapter for our company enabling the accelerated development of our Bisphosphocin® class of compounds," said Doug Manion, M.D., Chairman of the Board, in a statement. He emphasized the listing's role in advancing the company’s lead product, Nu-3.

The strategic move to go public comes as the company operates in a pre-revenue stage, reporting net losses in 2024 and 2025 as it heavily invests in research and development. This is a common financial profile for clinical-stage biotechs, where significant upfront investment is required to bring innovative therapies through the rigorous regulatory approval process.

Targeting a Critical Unmet Need

The public health challenge Lakewood-Amedex aims to tackle is substantial. According to recent data, close to 40 million people in the United States live with diabetes. Of those, approximately one-third will develop a diabetic foot ulcer (DFU) during their lifetime. These chronic wounds are notoriously difficult to heal, and the situation becomes dire when infection sets in, which occurs in about half of all cases.

"We look forward to accelerating our work targeting this major unmet need," stated Kelvin Cooper, Ph.D., the company's Chief Executive Officer. Dr. Cooper highlighted that many patients suffer from recurring ulcers and that "antibiotic-resistant bacterial strains are a major concern for the treatment of these patients."

DFUs are a leading cause of non-traumatic lower-limb amputations and represent a significant burden on healthcare systems. The global market for diabetic foot ulcer treatments reflects this urgency, estimated at approximately $5.67 billion in 2026 and projected to climb to over $10 billion by 2035. The rise of multi-drug resistant organisms like MRSA (methicillin-resistant Staphylococcus aureus) and VRE (vancomycin-resistant Enterococcus) has rendered many conventional antibiotics less effective, creating a desperate need for new therapeutic approaches.

The Science of Bisphosphocins and Nu-3

Lakewood-Amedex's core technology is its proprietary Bisphosphocin® class of antimicrobials, also known as nubiotics. These compounds represent a novel mechanism of action distinct from traditional antibiotics. Instead of targeting specific metabolic pathways, which bacteria can evolve to circumvent, Bisphosphocins work by rapidly disrupting the integrity of the bacterial cell membrane. This causes a swift depolarization of the membrane, leading to cell death within minutes.

This rapid, direct-acting mechanism is believed to significantly reduce the probability of bacteria developing resistance, a key potential advantage in the ongoing battle against superbugs. Furthermore, in vitro studies have shown that Nu-3 is effective against a broad spectrum of both Gram-positive and Gram-negative bacteria commonly found in infected wounds, including notorious pathogens like Staphylococcus aureus, Escherichia coli, and Pseudomonas aeruginosa. Critically, it has also demonstrated the ability to disrupt and eliminate bacteria established in biofilms—slimy, protective colonies that are notoriously impervious to conventional antibiotics.

Nu-3, the company's lead candidate, is formulated as a topical gel for direct application to the wound. Early exploratory clinical trials using subclinical doses of Nu-3 provided encouraging results, showing a positive trend in antimicrobial response and improved wound healing without any significant safety concerns. A Phase I/IIa study completed in 2017 confirmed that topically applied Nu-3 was well-tolerated in patients with infected diabetic ulcers. Following these promising early signals, the company is poised to take the next crucial step in its clinical journey.

Experienced Leadership and the Path Forward

Guiding Lakewood-Amedex through this pivotal phase is a leadership team with deep experience in pharmaceutical development. Chairman Doug Manion, M.D., has a long track record in the industry, having held senior research and development roles at major pharmaceutical companies including Bristol Myers Squibb and Arena Pharmaceuticals, as well as executive leadership positions at Aclaris Therapeutics and Kleo Pharmaceuticals. CEO Kelvin Cooper, Ph.D., is a veteran scientist with over 45 years of experience, including a distinguished career at Pfizer where he led worldwide pharmaceutical sciences and drug development for infectious diseases.

This combined expertise will be vital as the company moves forward. The immediate priority following the Nasdaq listing is the initiation of a Phase 2a clinical trial for Nu-3. This study is designed to evaluate the safety and dose-response of the topical gel in patients with mildly infected diabetic foot ulcers. The results will be critical for determining the optimal dose and administration regimen for a subsequent, larger placebo-controlled Phase 2b study.

As Lakewood-Amedex begins its life as a publicly traded entity, the focus of the market, clinicians, and patients will be fixed on the progress of this upcoming trial. The data generated will be the first major indicator of Nu-3's potential to become a much-needed new tool for treating a dangerous and debilitating condition.