Lakewood-Amedex Biotherapeutics Inc.
NASDAQ: LABT

Of the estimated 830 million people worldwide living with diabetes, about one third will develop a diabetic foot ulcer (DFU) during their lifetime. Close to half of those ulcers become infected, and many patients go through repeated infections in the years that follow. Between 15% and 20% of infected diabetic foot ulcers involve resistant pathogens, primarily methicillin-resistant Staphylococcus aureus (MRSA), a strain of staph bacteria that resists methicillin and related antibiotics.

Infection in a diabetic foot ulcer is a risk factor for amputation, as is peripheral arterial disease, a narrowing of the arteries that reduces blood flow to the legs and feet. The current standard of care pairs wound care with systemic antibiotics, drugs taken by mouth or by injection that circulate through the whole body, and outcomes remain poor, with high rates of recurrence and eventual amputation.

Lakewood-Amedex identifies only one direct and comparable competitor among proprietary topicals, Recce’s R327, a topical agent for skin and soft tissue infections with a focus on iDFU that is in late-stage development in Australia and Indonesia. Additionally, no approved topical exists for the treatment of iDFU, nor is a topical antimicrobial approved that has activity against resistant bacteria.

When Lakewood-Amedex’s peer-reviewed research on Nu-3 was published in October 2025, Chief Medical Officer Thomas Balzer, M.D., Ph.D., explained the clinical case for treating the wound directly: “Our research reinforces that locally applied antimicrobials like Nu-3 could overcome limitations of systemic antibiotics such as frequent systemic side effects, or the fact that in poorly perfused tissues, such as in patients with iDFU, oral applications often fail to reach therapeutic concentrations.”

Antimicrobial resistance is a global public health problem well beyond the diabetic foot, and the Global Research on Antimicrobial Resistance project, published in The Lancet in 2024, estimated that in 2021 about 1.14 million deaths worldwide were attributable to bacterial AMR and about 4.71 million were associated with it. In that study, attributable deaths are those estimated to have been caused by drug resistance itself, and associated deaths include every death in which a drug-resistant bacterial infection played a part. In the United States, an estimate published in 2021 put the annual healthcare cost of infections from six common multidrug-resistant pathogens at more than $4.6 billion.

Resistance is driven mainly by widespread use of systemic antibiotics, by frequent systemic use for infections that could be treated locally, and by antibiotic use in agriculture, specifically livestock. Newly developed systemic antibiotics face a barrier of their own, because they remain vulnerable to resistance since most belong to known and existing classes with a comparable mechanism of action, and therefore they are used clinically as reserve or third-line therapy.

In June 2026, a presidential advisory council met to discuss the next five-year National Action Plan on resistance, and in July Lakewood-Amedex announced its support for the reintroduction of the bipartisan PASTEUR Act, legislation designed to encourage the development of novel therapies against AMR.

Bisphosphocin® compounds are novel, small nucleotide derivatives, modified versions of the molecular building blocks of DNA and RNA, and the proposed mechanism is that they attack bacterial cell membranes, causing rapid cell death. In laboratory experiments the compounds destabilize the bacterial membrane in a way that depends on both pH, a measure of acidity, and concentration, and the destabilization itself typically occurs within minutes of exposure.

Kelvin Cooper, Ph.D., Chief Executive Officer, has described the compounds as modified nucleotide molecules with excellent solubility in water, a property that could make them adaptable to a range of drug formulations and delivery methods. He ties that property to the potential of the class in additional indications such as complicated urinary tract infection and pulmonary infections, beyond the topical gel now in clinical development for the diabetic foot.

In laboratory testing, Nu-3 has shown broad-spectrum activity against both gram-positive and gram-negative bacteria, the two major groups of bacteria, distinguished by the structure of their cell walls. That activity extends to resistant strains such as MRSA and VRE (vancomycin-resistant Enterococci), and in preclinical testing the class has worked against biodefense pathogens. It has also shown cidal, or bacteria-killing, activity against biofilm organisms, bacterial colonies that coat surfaces in a protective layer.

Prolonged exposure to antibiotics can play a part in selecting resistant bacteria, and Lakewood-Amedex’s view is that the rapid cidal action of the class, together with its physical action on the membrane, lowers the odds that resistance will develop.

Nu-3 was selected for clinical development on the strength of laboratory activity, mouse infection models, formulation work and a toxicology program, and much of the activity data appeared in October 2025 in the peer-reviewed journal Antimicrobial Agents and Chemotherapy.

Time-kill experiments track how quickly a compound eliminates a bacterial population, and there the Bisphosphocin® class works fast, with total cell death within minutes at higher concentrations and lower pH values. Tested in vitro, meaning in laboratory culture outside a living organism, Nu-3 killed, for example, all of the exposed Escherichia coli (E. coli) within 10 minutes at 25 mg/ml, a 2.5% concentration, and within five minutes or less at 50 and 100 mg/ml, or 5% and 10%. Bacteria in the vehicle control, the same preparation without Nu-3, were unaffected over the 20-minute time course.

In the testing published in that paper, Nu-3 was active against multidrug-resistant pathogens commonly found in diabetic foot infections, including Staphylococcus aureus, E. coli, Pseudomonas aeruginosa, Klebsiella pneumoniae and Acinetobacter baumannii, and it eradicated bacteria within minutes at concentrations achievable in a topical formulation.

Results reported in September 2026 extended the in vitro work to recent clinical isolates, bacteria collected over the past three years from patients with diabetic foot infections at 14 medical centers in the United States. The panel included methicillin-resistant and methicillin-susceptible strains of Staphylococcus aureus (MRSA and MSSA) and vancomycin-resistant and vancomycin-susceptible strains of Enterococcus faecalis (VRE and VSE). The study measured the Minimum Inhibitory Concentration (MIC), the lowest concentration of a drug that stops visible bacterial growth. Nu-3 showed consistent activity against every organism tested, and whether a strain was drug resistant made no difference to that activity. The results fell within the range of earlier assays run on 285 clinical isolates covering 15 species.

Lakewood-Amedex tested resistance directly in serial passage experiments, in which bacteria are grown repeatedly in the presence of a drug to see whether they adapt to it. Over 21 days of serial passage of E. coli and MRSA with Nu-3, the MIC rose slightly for E. coli and was unchanged for MRSA. In the same experiment, the MIC for the antibiotic ciprofloxacin, run as a control, rose more than 2,000-fold for E. coli and more than 600-fold for MRSA. Nu-3 also kept its original MIC against the bacteria that had become resistant to ciprofloxacin, which indicates that cross-resistance between the two drugs did not occur in that experiment.

In July 2026 the company reported further laboratory profiling that showed broad-spectrum in vitro activity against bacteria with a diverse range of resistance mechanisms, including changes to the part of the bacterium that an antibiotic targets, direct metabolism of the drug by the bacterium, and efflux pumps that push a drug back out of the cell. Those findings and the passage results are the laboratory basis for Lakewood-Amedex’s expectation of a high barrier to resistance.

To choose between gel and solution, Lakewood-Amedex ran a murine dermal infection model, which uses mice with established skin infections. Both the 10% gel and the 10% solution of Nu-3 inhibited MRSA growth by more than 95% at one and two hours after treatment. At four hours the gel outperformed the solution in blocking MRSA growth, and the difference was larger still at eight hours. That longer duration of activity in the mouse model supports the gel as the dosage form for topical application.

A five-day multiple-dose mouse infection model then compared once-a-day and twice-a-day application of the gel. After five days of treatment with 5% Nu-3 gel, MRSA growth was more than 95% inhibited with both regimens, and after a further five days of recovery without treatment, the twice-a-day regimen controlled MRSA growth better than the once-a-day regimen. The Phase 2b study expected to follow the Phase 2a would test Nu-3 gel as either a once-a-day or a twice-a-day treatment against placebo.

Preclinical safety work reported in July 2026 underpins the doses now being tested in patients: in the safety study required by the U.S. Food and Drug Administration (FDA), Nu-3 was well tolerated at dose levels substantially higher than those chosen for the Phase 2a trial and did not inhibit wound healing, and systemic exposure was very low, which points to a low potential for systemic side effects. The broader toxicology program found minimal effects at high doses in both intravenous and topical safety studies. Together with the in vitro and animal activity data, those results supported the choice of the three gel concentrations now in the Phase 2a trial.

Registered as ClinicalTrials.gov NCT07565506, the Phase 2a trial is a multicenter, single-blinded, randomized, dose-finding study evaluating Nu-3 in adult patients with Type 1 or Type 2 diabetes and infected diabetic foot ulcers. It compares three Nu-3 gel concentrations, 2%, 5% and 10%, with active treatment from day 1 to day 14 followed by a follow-up period through day 28. On September 24, 2026, Lakewood-Amedex announced that the first patient had been dosed, and topline data are expected in the first quarter of 2027.

Lakewood-Amedex designed the study to evaluate the safety and efficacy of each concentration, including Nu-3’s ability to reduce microbial burden and resolve infection, and to guide dose selection for the rest of the clinical development program. Safety is assessed through the adverse events recorded in each dose group, including those related to treatment and those classed as serious. Efficacy measures center on the reduction in colony-forming units (CFU), a count of viable bacteria, at days 7 and 14 compared with baseline, and the study also tracks clinical infection scores and changes in wound size. The goal of the Phase 2 program is clinical proof of concept for safety and antimicrobial efficacy.

Before the move to the gel, Lakewood-Amedex completed a Phase 1 safety study and an exploratory Phase 2 clinical trial of Nu-3 in solution. The Phase 1 study was a 21-day repeat patch test of the irritation potential of 2% Nu-3 in saline on abraded and intact skin sites, with controls, in 35 healthy subjects, and it produced no findings on intact skin and a minimal reaction on abraded skin at 2%.

That exploratory Phase 2 trial, run in patients with iDFU, was double-blinded, randomized and dose-escalating, and it compared Nu-3 solution at 0.1%, 1% and 2% with placebo in 30 patients analyzed. It produced no relevant safety findings and showed a trend toward pathogen reduction and ulcer surface area reduction only at 2%. Lakewood-Amedex concluded that Nu-3 is well tolerated and safe and that the doses had not been high enough, a finding that led to additional toxicology studies at higher concentrations. It also made the decision to change the formulation from solution to gel.

Nu-3 enters the current trial with positive preclinical safety data, those early exploratory results and an open and active Investigational New Drug application (IND), the filing with the FDA that allows a candidate to be tested in people.

David G. Armstrong, DPM, M.D., Ph.D., Distinguished Professor of Surgery and Neurological Surgery at the Keck School of Medicine of USC, is Study Chair for the Phase 2a trial, providing scientific leadership and oversight, and a Scientific Advisor on the Lakewood-Amedex iDFU program. When he accepted the role in June 2026, he said: “A topical antimicrobial such as Nu-3 fits well with the ongoing evolution of diabetic foot ulcer management, and if clinical studies demonstrate its effectiveness, it has the potential to help address an important treatment gap for patients suffering from these serious infections.”

Professional Education and Research Institute LLC (PERI), a contract research organization specializing in wound care and podiatric clinical research, is managing the trial under an agreement Lakewood-Amedex announced in May 2026. PERI was founded and is led by Charles Zelen, DPM, FACFAS, a practicing podiatrist with deep ties to the diabetic foot care community, and it brings an established network of investigators and access to relevant clinical sites, which are expected to help with patient recruitment and data quality.

Lakewood-Amedex’s manufacturing work has produced several multikilogram-scale runs of drug substance, the active ingredient, for members of the Bisphosphocin® class under current Good Manufacturing Practices (cGMP) guidelines. Multikilogram quantities of Nu-3 gel have also been manufactured under cGMP, and the gel is suitable for use in clinical trials. Stability testing has shown the bulk drug substance stable for at least five years and the gel for at least two years, and initial microbial testing of the gel found undetectable bioburden, meaning no detectable viable microorganisms, over that two-year period with no added preservatives.

In September 2026, Lakewood-Amedex announced central and all-site Institutional Review Board (IRB) approvals, the independent ethics reviews required before patients can be enrolled, along with confirmed clinical trial site readiness for the Phase 2a study.

After the Phase 2a, the program is expected to move to a Phase 2b study testing different gel concentrations of Nu-3, given once or twice a day, against placebo. That study is planned as a double-blinded, randomized trial. The treatment groups will be confirmed after the Phase 2a readout.

Phase 2 will run in the United States and Phase 3 internationally under the company’s plan, with an End of Phase 2 meeting, the regulatory review that precedes Phase 3, marking the handoff between them. Two small accessory studies are planned in parallel, one on full pharmacokinetics, how the body absorbs and clears a drug, and one on skin sensitization. Phase 3 is planned to include active comparator trials and longer follow-up intended to establish clinical utility on wound healing, and the final commercial dosage form is to be defined by the end of Phase 2 so that it is ready when Phase 3 starts.

Nu-3 leads the Bisphosphocin® development pipeline in skin and soft tissue infections such as infected diabetic foot ulcers, with Nu-8 at the preclinical stage behind it and Nu-10 and Nu-11 in discovery. Those three compounds are being profiled for potential indications in pulmonary infections, urinary tract infections, oral mucositis (a painful inflammation and ulceration of the lining of the mouth) and otitis externa (an infection of the outer ear canal).

Animal data reported in October 2026 cover two of those indications, urinary tract infection (UTI) and pulmonary infection. In the UTI model, intravesical administration of Nu-8, meaning delivery directly into the bladder, in rodents infected with E. coli produced up to 97% inhibition of E. coli growth with a 10% solution, against no effect in the vehicle control group. Complicated UTIs, especially those tied to urinary catheters, are frequently caused by drug-resistant bacteria and bacterial biofilm.

Delivered as an aerosol, Bisphosphocin® compounds have also shown in vivo activity, meaning activity in living animals, in animal models of pulmonary infection caused by Acinetobacter species, Pseudomonas aeruginosa and the mold Aspergillus fumigatus. In the laboratory, the class has shown in vitro activity against a broad range of resistant bacteria common in urinary and pulmonary infections, including E. coli, Klebsiella pneumoniae, Pseudomonas aeruginosa and Haemophilus influenzae.

When the animal data were announced, Kelvin Cooper, Ph.D., described the next step for those earlier-stage compounds: “We look forward to continuing development of the various Bisphosphocin® compounds to identify the most suitable candidate to be advanced into early clinical development.”

Lakewood-Amedex protects the platform with 72 granted patents and 29 pending applications in multiple countries and regions, including the United States, the European Patent Office, China, India, Japan, Mexico, Hong Kong, the Republic of Korea, Brazil, the United Kingdom, New Zealand and Australia. Coverage includes composition-of-matter patents, which protect the compounds themselves, on the Bisphosphocin® class and related classes of compounds, along with formulation patents on Nu-3, use patents for the class and process patents covering how the compounds are made. Principal filings provide protection through 2038, and more recent applications extend the potential term of protection through 2044.

Patents granted in New Zealand and Australia in early 2026 extended protection for the Nu-3 gel itself and brought the granted patents on the gel formulation to 27 across the United States, Europe, Asia, Brazil and Australasia. Those patents cover a gel designed to adhere to wounds and built on lyotropic liquid crystals, structured materials that take shape in the presence of water. A further Australian patent issued in March 2026 covers composition of matter for Bisphosphocin® compounds being explored in a range of infections, including complicated urinary tract infections and pulmonary infections.

Just before its Nasdaq listing, Lakewood-Amedex completed a private placement of Series C Convertible Preferred Stock with an accredited investor for approximately $7.5 million in gross proceeds and approximately $6.8 million net of placement agent commissions and other offering costs. Its common stock began trading on the Nasdaq Capital Market on April 23, 2026 through a direct listing, which takes existing shares onto an exchange with no underwritten offering of new shares.

With the listing, all outstanding shares of Series A and Series B Convertible Preferred Stock and the convertible promissory notes converted automatically into common stock, which in management’s words simplified the capital structure. The private placement supports the continued clinical advancement of Nu-3, and Lakewood-Amedex sees the Nasdaq listing as giving it greater visibility and broader access to the public capital markets as it pursues its clinical and strategic objectives.

As of August 3, 2026, Lakewood-Amedex had 2,369,688 shares of common stock outstanding, and as of June 30, 2026 its authorized common stock totaled 12,500,000 shares with a par value of $0.0001 per share.

Lakewood-Amedex’s stated priorities are advancing Nu-3 through Phase 2 clinical development, generating the clinical evidence needed to show its potential in infected diabetic foot ulcers, and laying the groundwork for broader development of the Bisphosphocin® platform. After Phase 2, it plans to run the Phase 3 program in iDFU with a partner, for global reach and capabilities.

Kelvin Cooper, Ph.D., Chief Executive Officer and Senior Vice President of Research and Development, is a pharmaceutical scientist and executive with 45 years in the industry, 30 of them at Pfizer, and has held executive roles spanning drug discovery, drug development, manufacturing and commercial work. His Pfizer roles included Senior Vice President of Worldwide Pharmaceutical Sciences and Senior Vice President for Portfolio Development in the Established Pharmaceutical Sciences Business Unit. He served as Chief Operating Officer of Lakewood-Amedex before becoming Chief Executive Officer in February 2025, and he holds a Ph.D. in Organic Chemistry from the University of Nottingham.

Thomas Balzer, M.D., Ph.D., Chief Medical Officer and Senior Vice President, Clinical Development, brings 30 years in the pharmaceutical industry at Schering AG, Bayer US and Exact Sciences, including executive leadership roles in global clinical development and global medical affairs at Bayer US.

Peter Ceccacci, Chief Financial Officer, has more than 25 years as a senior executive across accounting, finance, strategy, compliance and management. He previously served as the company’s Chief Accounting Officer and Vice President, Administration, and earlier as Chief Financial Officer of Genius Central Systems Inc. and as a partner at accounting firms including EisnerAmper and RD Hunter and Company LLP. He holds a Bachelor of Science in Accounting from Susquehanna University.

Douglas Manion, M.D., FRCP(C), Chairman of the Board, has served as a director since 2021 and was named Chairman in February 2025. He previously served as Chief Executive Officer of Aclaris Therapeutics, as Executive Vice President of Research and Development at Arena Pharmaceuticals, and as Senior Vice President and Head of Specialty Development at Bristol Myers Squibb. He is board certified in internal medicine and completed a fellowship in infectious diseases in Ottawa, Canada.

Leonard J. DeRoma, Director, has spent his career in the capital markets, with senior roles at Citibank, Lehman Brothers and Barclays Capital.

Joseph Tucker, Ph.D., Director, joined the board in April 2026 and is Chief Executive Officer and a director of Enveric Biosciences (Nasdaq: ENVB). He brings more than two decades of leadership experience across public and private biotechnology companies, including Chief Executive Officer, Executive Chairman and director roles at Willow Biosciences and Stem Cell Therapeutics, and he has raised more than $100 million in capital over his career.

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