By David Bautz, PhD
NASDAQ: LABT
READ THE FULL LABT RESEARCH REPORT
Business Update
Finalizing Preparations for Phase 2a Trial of Nu-3 in infected diabetic foot ulcers
Lakewood-Amedex Biotherapeutics (NASDAQ: LABT) is continuing final preparations for the upcoming Phase 2a clinical trial of Nu-3 in patients with infected diabetic foot ulcers (iDFUs). The trial will evaluate three different doses of Nu-3 gel (2%, 5%, and 10%) in non-hospitalized, diabetic patients with signs of a localized, mild foot infection (NCT07565506). Patients will be treated once daily for 14 days. The primary outcomes of the study will be safety and efficacy, as measured by a reduction in CFUs ≥ 2 logs per pathogen identified at Day 7 and Day 14 compared to Day 0. An overview of the study, along with the planned Phase 2b trial, is given below.
In support of the upcoming Phase 2a study, Lakewood recently announced positive preclinical safety data supporting selection of the Phase 2a doses. Nu-3 was well tolerated at dose levels substantially above those planned for clinical evaluation, with very low systemic exposure and no evidence of impaired wound healing. The results, together with in vitro and animal efficacy data, support evaluation of the 2%, 5%, and 10% gel concentrations in the upcoming Phase 2a study. These safety findings are important to the company as they further reduce a key preclinical hurdle ahead of clinical testing.
Lakewood also recently highlighted additional in vitro data supporting Nu-3’s potential to address antimicrobial resistance. Nu-3 did not induce resistance in a serial passage experiment and demonstrated activity against bacteria carrying a range of resistance mechanisms, including antibiotic target modification, drug metabolizing enzymes, and efflux mechanisms. While these findings remain preclinical, they are consistent with the proposed physical mechanism of action of the Bisphosphocin platform and reinforce the potential differentiation of Nu-3 in the iDFU setting.
Lastly, the company announced the appointment of David G. Armstrong, DPM, MD, PhD, as Study Chair for the upcoming Phase 2a trial and as a Scientific Advisor for the iDFU program. Dr. Armstrong is a leading expert in diabetic foot care, including infection control, wound healing, and limb preservation. He has authored hundreds of peer-reviewed scientific publications and has helped shape modern care for patients with diabetes-related complications.
Financial Update
On August 14, 2026, Lakewood-Amedex filed Form 10-Q with financial results for the second quarter of 2026. As expected, the company did not report any revenues for the second quarter of 2026. R&D expenses for the three months ending June 30, 2026 were $503,000 compared to $147,000 for the three months ending June 30, 2025. The increase was primarily due to increased compensation along with manufacturing, regulatory, and other activities supporting the planned Phase 2a trial of Nu-3 in iDFU. G&A expenses for the second quarter of 2026 were approximately $3.3 million compared to $489,000 for the second quarter of 2025. The increase was primarily due to increased professional services, along with higher Nasdaq listing and compliance costs.
As of June 30, 2026, Lakewood had approximately $4.6 million in cash and cash equivalents due in part to the net proceeds of approximately $6.8 million from a private placement of Series C Convertible Preferred Stock in April 2026. We estimate the company’s current cash position will be sufficient to fund operation through the end of 2026. As of August 3, 2026, Lakewood had approximately 2.4 million shares of common stock and, when factoring in stock options, warrants, and Series C convertible preferred stock, a fully diluted share count of approximately 3.5 million.
Conclusion
Lakewood has continued to advance towards initiation of the Phase 2a trial of Nu-3 with the addition of a highly regarded DFU expert as Study Chair, positive preclinical safety findings, and selection of the clinical dose levels. We look forward to initiation of the study, with the data generated providing the first meaningful test of whether the encouraging preclinical efficacy, safety, and resistance profile of Nu-3 can translate to patients. With no changes to our model, our valuation remains at $12 per share.
SUBSCRIBE TO ZACKS SMALL CAP RESEARCH to receive our articles and reports emailed directly to you. Please visit our website for additional information on Zacks SCR.
DISCLOSURE: Zacks SCR has received compensation from the issuer directly, from an investment manager, or from an investor relations consulting firm, engaged by the issuer, for providing research coverage for a period of no less than one year. Research articles, as seen here, are part of the service Zacks SCR provides and Zacks SCR receives payments totaling a maximum fee of up to $50,000 annually for these services provided to or regarding the issuer. Full Disclaimer HERE.