Lakewood-Amedex Biotherapeutics Announces Positive Data Against Recent Clinical Isolates from Infected Diabetic Foot Ulcers

Rhea-AI Summary

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.

Positive

• Nu-3 activity was not affected by the tested bacteria’s drug-resistance status.
• MIC values were 2–8 times lower than doses planned for clinical trials.
• Activity across tested organisms was within the range of earlier assays involving 285 isolates across 15 species.
• Clinical isolates came from patients at 14 U.S. medical centers and were collected within the past three years.

Negative

• In vitro findings do not report patient outcomes; Phase 2a topline data are expected in the first quarter of 2027.

Argus Sep 28 session 111 alerts

-31.14% close to close 27.5x rel. volume Open Argus

Details

Market move: LABT -31.14% in the Sep 28 session. Nu-3 clinical-isolate data

+135.6% Peak Tracked

-31.3% Trough Tracked

$8.93M Mkt Cap at Peak Alert

On Sep 28, the day this news came out, LABT closed 31.14% below the previous close. Argus tracked a peak move of +135.6% during that session. Argus tracked a trough of -31.3% from its starting point during tracking. Our momentum scanner recorded 111 alerts for this stock that day. That session’s volume was 27.5x the stock’s average daily volume.

Data tracked by StockTitan Argus for the Sep 28 session.

Key Figures

Clinical-isolate testing sites: 14 medical centers MIC values versus planned doses: 2-8 times lower Prior assay isolates: 285 clinical isolates +2 more

Clinical-isolate testing sites

14 medical centers

U.S. centers supplying isolates from patients with diabetic foot infections

MIC values versus planned doses

2-8 times lower

Nu-3 testing against recent clinical isolates

Prior assay isolates

285 clinical isolates

Previous assay results referenced for comparison

Prior assay species

15 species

Species covered in the previous assay results

Expected topline data

First quarter of 2027

Nu-3 Phase 2a clinical trial

Historical Context

2 past events · Latest: Sep 24

2 events

1. Sep 24

   Phase 2a trial start

   24h Move

   +2.5%

   First patient dosed in the Nu-3 Phase 2a trial for infected diabetic foot ulcers.

2. Jul 22

   Resistance data

   24h Move

   +83.3%

   Nu-3 showed broad-spectrum in-vitro activity across resistance mechanisms without induced resistance in serial passage.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Key Terms

mic, mrsa, mssa

3 terms

mic medical

"positive Minimum Inhibitory Concentration (MIC) data from recent clinical isolates"

A Market Identifier Code (MIC) is a four‑character, standardized code assigned to trading venues, exchanges and other marketplaces so each can be uniquely identified in electronic systems. Think of it like an airport code for places where securities trade; it tells brokers, data services and investors exactly which market a trade or price came from. It matters because the MIC ensures accurate routing, reporting and comparison of trades and prices across different venues.

mrsa medical

"resistant and susceptible Staphylococcus aureus (MRSA and MSSA respectively)"

MRSA is a type of common bacteria that has become resistant to many standard antibiotics, causing infections that are harder to treat. Think of it like a weed that no longer responds to the usual weedkiller; it raises the need for stronger medicines, longer hospital stays, and new products or procedures. For investors, MRSA affects healthcare costs, drug and diagnostic demand, regulatory scrutiny, and potential legal or reputational risks for providers and drugmakers.

mssa medical

"resistant and susceptible Staphylococcus aureus (MRSA and MSSA respectively)"

Methicillin-susceptible Staphylococcus aureus (MSSA) is a strain of the common bacterium Staphylococcus aureus that can be killed or controlled by methicillin-class antibiotics because it lacks the resistance mechanisms found in MRSA. It matters to investors because MSSA is a frequent target in clinical trials, diagnostics and hospital treatments; the size of the MSSA patient population and available therapies influence demand for antibiotics, diagnostics, medical devices and related healthcare products—like a common problem that responds to standard solutions.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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Lead candidate Nu-3 is a topically formulated Bisphosphocin^®, designed to rapidly kill microbes while reducing the risk of antimicrobial resistance

SARASOTA, Fla., Sept. 28, 2026 /PRNewswire/ -- Lakewood-Amedex Biotherapeutics Inc., (NASDAQ: LABT, the "Company"), a clinical-stage biotechnology company advancing a novel class of potent, fast-acting, broad-spectrum antimicrobials for infectious diseases called the Bisphosphocin^® class, announced positive Minimum Inhibitory Concentration (MIC) data from recent clinical isolates for its lead clinical candidate, Nu-3. Nu-3 is currently being investigated in a Phase 2a clinical trial as a topical treatment of mildly infected diabetic foot ulcers (iDFU) with topline data expected in the first quarter of 2027.

MIC testing analysis of Nu-3 assessed in vitro activity against recent clinical isolates (collected within the last 3 years) from infected diabetic foot ulcers. Lakewood-Amedex Biotherapeutics evaluated the bactericidal activity of Nu-3 against several resistant pathogens, including resistant and susceptible Staphylococcus aureus (MRSA and MSSA respectively) and resistant and susceptible Enterococcus faecalis (VRE and VSE respectively). The clinical isolates utilized in the study were collected across 14 medical centers in the U.S. from patients suffering from diabetic foot infections.

"The positive MIC data in clinical isolates are another encouraging signal supporting continued study of Nu-3 and the Bisphosphocin class," said Kelvin Cooper, Ph.D., Chief Executive Officer of Lakewood-Amedex Biotherapeutics. "Importantly, the data show clear and positive cidal activity against specific microbes isolated from real world patients. These microbes are a clear threat to patients with iDFU, and more broadly represent the global threat of antibiotic resistance."

In the study, Nu-3 demonstrated consistent activity against all organisms, which were within the range of previous assay results conducted with 285 clinical isolates covering 15 varied species. Notably, indicating a favorable dosing margin and a strong therapeutic window, the MIC values were 2-8 times lower than the planned doses for clinical trials. Antibacterial activity of Nu-3 was not affected by the drug resistance phenotype. S. aureus (ATCC 29213) and E. faecalis (ATCC 29212) were used as control strains.

iDFUs represent a significant unmet medical need, affecting millions of patients worldwide and often leading to hospitalization and amputation if the infection cannot be controlled in early stages. Of the 830 million people in the world with diabetes, about one third will develop a DFU. Close to 50% of DFUs become infected, and 15–20% of iDFUs involve resistant pathogens (primarily MRSA).

About Lakewood-Amedex Biotherapeutics Inc.
Lakewood-Amedex Biotherapeutics Inc. (NASDAQ: LABT) is a clinical-stage biotechnology Company developing a novel class of fast-acting, broad-spectrum antimicrobials – the Bisphosphocin^® class - to treat infectious diseases and reduce the threat posed by antibiotic-resistant bacterial strains, including MRSA, VRE, and others. For more information, please visit https://lakewoodamedex.com.

Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding Lakewood-Amedex Biotherapeutics Inc.'s clinical development plans, regulatory strategy, anticipated trial timing, potential regulatory submissions or approvals, and the potential benefits, safety, efficacy and commercial potential of its Bisphosphocin® platform and product candidates. These statements are based on current expectations and assumptions and are subject to risks and uncertainties that could cause actual results to differ materially, including risks that clinical trials may not be initiated, completed or successful on expected timelines or at all; preclinical or clinical results may not be predictive of future results; product candidates may not demonstrate safety or efficacy or receive regulatory approval; and risks related to manufacturing, supply, financing and other matters described in the company's SEC filings, including under "Risk Factors." Forward-looking statements speak only as of the date of this press release, and the company undertakes no obligation to update them except as required by law.

Contact

Investor Relations
Tiberend Strategic Advisors, Inc.
David Irish
(231) 632-0002
dirish@tiberend.com 

Media Relations
Tiberend Strategic Advisors, Inc.
Casey McDonald
646-577-8520
cmcdonald@tiberend.com 

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SOURCE Lakewood-Amedex Biotherapeutics Inc.

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

What did Lakewood-Amedex’s Nu-3 testing show against diabetic foot ulcer isolates?

Nu-3 showed in vitro activity against the tested isolates, including resistant and susceptible forms of Staphylococcus aureus and Enterococcus faecalis. Drug-resistance status did not affect its antibacterial activity, and MIC values were 2–8 times lower than doses planned for clinical trials.

When does Lakewood-Amedex expect Phase 2a Nu-3 results?

Topline data are expected in the first quarter of 2027. The ongoing trial is studying topical Nu-3 as a treatment for mildly infected diabetic foot ulcers.