Lakewood-Amedex Biotherapeutics reports developments tied to its clinical-stage antimicrobial pipeline and public-company status. News items cover the Bisphosphocin® class, antimicrobial resistance data for the lead compound Nu-3, and the company’s development work for infected diabetic foot ulcers, with additional platform references to complicated urinary tract infection and pulmonary infections.
Company updates also include Nasdaq listing activity under the LABT symbol and governance changes following its direct listing. These announcements describe the company’s transition into a Nasdaq-traded biotechnology issuer while continuing to center on its proprietary antimicrobial platform.
Lakewood-Amedex Biotherapeutics (NASDAQ: LABT) announced research on its antimicrobial candidate Nu-3 for presentation at IDWeek on October 22, 2026.
Laboratory testing showed activity against Gram-positive, Gram-negative and multidrug-resistant bacteria, with eradication within minutes for tested pathogens and activity against biofilm organisms. Serial-passage testing showed only a slight increase in minimum inhibitory concentration, the amount needed to stop bacterial growth, against Staphylococcus aureus and Escherichia coli, versus a 600- to 2,000-fold increase for ciprofloxacin. Nu-3 is in an ongoing Phase 2a trial for mildly infected diabetic foot ulcers; the company expects topline data in the first quarter of 2027.
Lakewood-Amedex Biotherapeutics (LABT) announced preclinical results for its Bisphosphocin compounds in animal models of urinary tract and pulmonary infections.
Nu-8, administered directly into the bladder as a 10% solution, inhibited E. coli growth by up to 97% in infected rodents, versus no effect with vehicle control. Aerosol formulations also showed activity in animal models of pulmonary infections caused by Acinetobacter species, P. aeruginosa and A. fumigatus. Laboratory testing showed activity against resistant bacteria associated with both infection types and against biofilm-forming organisms.
The company plans further development to identify a candidate for early clinical development. Separately, Nu-3 topical gel is being studied in an ongoing Phase 2a trial for mildly infected diabetic foot ulcers; the company expects topline data in the first quarter of 2027.
Lakewood-Amedex Biotherapeutics (LABT) announced that CEO Kelvin Cooper will participate in three industry conferences in October 2026, including two presentations.
He is scheduled to attend the Maxim Growth Summit in New York City on October 14 and attend and present at ThinkEquity there on October 15. He will present a poster on Nu-3 preclinical data at IDWeek in Washington, D.C., on October 22.
Lakewood-Amedex Biotherapeutics (LABT) reported in vitro Nu-3 activity against recent bacterial isolates from infected diabetic foot ulcers. The isolates were collected within the past three years from patients at 14 U.S. medical centers. Testing included resistant and susceptible forms of Staphylococcus aureus and Enterococcus faecalis; Nu-3 activity was not affected by their drug-resistance status.
Nu-3 activity across the tested organisms was within the range of earlier assays involving 285 clinical isolates across 15 species. Minimum inhibitory concentration (MIC) values were 2–8 times lower than doses planned for clinical trials. Nu-3 is being studied as a topical treatment for mildly infected diabetic foot ulcers in a Phase 2a trial, with topline data expected in the first quarter of 2027. The laboratory findings do not report patient outcomes.
Lakewood-Amedex Biotherapeutics (LABT) dosed the first patient in its Phase 2a Nu-3 trial for mildly infected diabetic foot ulcers. The multicenter, single-blinded study evaluates adults with Type 1 or Type 2 diabetes. It tests three concentrations of Nu-3 topical antimicrobial gel: 2%, 5% and 10%. The study is designed to assess safety and efficacy, including whether Nu-3 reduces microbial burden and resolves infection, and to inform dose selection for further development.
Nu-3 is part of the company's Bisphosphocin antimicrobial platform. Professional Education and Research Institute (PERI), a contract research organization with wound care and podiatric clinical research expertise, manages the trial. Lakewood-Amedex expects topline Phase 2a data in the first quarter of 2027. The company expects the program to advance afterward to a Phase 2b study comparing different Nu-3 gel concentrations, given once or twice daily, with placebo.
Lakewood-Amedex Biotherapeutics (LABT) released a CEO letter on September 21, 2026 outlining recent clinical, corporate and financing progress as Nu-3 moves toward Phase 2a evaluation in infected diabetic foot ulcers (iDFUs).
The company listed its common stock on the Nasdaq Capital Market on April 23, 2026 and completed a $7.5 million private placement of Series C Convertible Preferred Stock, which, together with automatic conversion of prior preferred stock and notes, improved liquidity and simplified the capital structure. Preclinical data for Nu-3 Gel showed low systemic exposure, no interference with wound healing, and supported selection of 2%, 5% and 10% doses for the upcoming Phase 2a trial, while demonstrating rapid broad-spectrum bactericidal activity against multidrug-resistant pathogens.
Lakewood-Amedex now holds 72 granted patents and 29 pending applications worldwide and has appointed diabetic foot experts David G. Armstrong and PERI, led by Charles M. Zelen, to guide the Phase 2a program. Of 937,500 Series C preferred shares issued, 486,260 have converted into common and 451,240 remain, with a maximum of 4,512,400 common shares issuable subject to price-based conversion terms and a 4.99% ownership cap.
The company filed a registration statement covering the conversion shares and will ask shareholders at the September 22 annual meeting to increase authorized common shares from 12.5 million to 100 million and to authorize a reverse split of up to 1-for-20, which it states would only be used if needed to maintain Nasdaq listing requirements.
Lakewood-Amedex Biotherapeutics (LABT) received central and site IRB approvals and confirmed clinical site readiness to begin a Phase 2a trial of Nu-3 for mildly infected diabetic foot ulcers. The study will evaluate the safety and efficacy of Nu-3, the company’s lead product candidate, in patients with iDFU, a condition described as a leading cause of lower-limb amputations worldwide. The trial is designed to build on positive preclinical safety data and early exploratory findings in which Nu-3 was well-tolerated and showed trends of improved antimicrobial response and wound healing. Nu-3 is a proprietary topical gel that uses a mechanism of action aimed at destabilizing microbial cell membranes, which is described as providing a high barrier to the development of antimicrobial resistance. The company states that this development remains aligned with federal mandates from the Presidential Advisory Council on Combating Antibiotic-Resistant Bacteria for innovative, resistance-evading therapies.
Lakewood-Amedex Biotherapeutics (LABT) will present at the H.C. Wainwright 28th Annual Global Investment Conference, held September 14-16, 2026, in New York City.
CEO Kelvin Cooper, Ph.D., will deliver a virtual presentation on the company’s Bisphosphocin® antimicrobial platform. During the conference, he will also hold one-on-one meetings with registered investors and potential partners to discuss the company’s business and clinical development strategy, recent corporate achievements, and anticipated milestones.
Lakewood-Amedex Biotherapeutics (NASDAQ: LABT) highlighted new resistance data for its Phase 2-ready antimicrobial candidate Nu-3, being developed for infected diabetic foot ulcers (iDFU). Nu-3 targets and disrupts bacterial membranes via a unique, physical mechanism of action and has shown a high barrier to resistance.
According to Lakewood-Amedex Biotherapeutics, Nu-3 did not induce resistance in a serial passage experiment and demonstrated broad-spectrum in vitro activity against bacteria harboring diverse resistance mechanisms, including target modifications (e.g., vanA/vanB, mec, rpoB, PBP2x), β-lactamase variants (NDM, ESBL, AmpC, CRE), sul2-mediated metabolic resistance, and efflux pumps. The company positions its Bisphosphocin® platform as aligned with the U.S. National Action Plan on Combating Antibiotic-Resistant Bacteria discussed at the June 16, 2026 PACCARB meeting.
Lakewood-Amedex Biotherapeutics (NASDAQ: LABT) reported preclinical safety results for its Nu-3 gel, a Bisphosphocin®-based topical antimicrobial being developed for infected diabetic foot ulcers (iDFU). The FDA-required safety study showed Nu-3 was well tolerated at dose levels substantially higher than those planned for the upcoming Phase 2a trial and did not inhibit wound healing.
According to the company, systemic exposure to Nu-3 was very low, supporting a low potential for systemic side effects. Based on combined in vitro, in vivo and safety data, Lakewood-Amedex Biotherapeutics has selected 2%, 5% and 10% Nu-3 gel concentrations for evaluation in a Phase 2a iDFU study that is nearing initiation.