Lakewood-Amedex Biotherapeutics Announces Preclinical Safety Data Supporting Clinical Dose Selection for Upcoming Phase 2a Trial of Nu-3 Gel

Rhea-AI Summary

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.

Positive

• Nu-3 well tolerated at doses above planned Phase 2a levels
• Safety study showed no inhibition of wound healing
• Systemic exposure very low, suggesting low systemic side-effect risk
• Phase 2a doses selected at 2%, 5% and 10% gels
• Supports Phase 2a readiness in infected diabetic foot ulcers (iDFU)

Negative

• None.

Market reaction after Nu-3 preclinical safety data: LABT -4.71% in the Jul 15 session

-4.71% 3.0x vol

25 alerts

-4.71% Session close to close

+10.0% Peak Tracked

-38.9% Trough Tracked

$4.78M Market Cap

3.0x Rel. Volume

In the Jul 15 session, LABT declined 4.71%, reflecting a moderate negative market reaction. Argus tracked a peak move of +10.0% during that session. Argus tracked a trough of -38.9% from its starting point during tracking. Our momentum scanner triggered 25 alerts that day, indicating elevated trading interest and price volatility. Trading volume was very high at 3.0x the daily average, suggesting heavy selling pressure.

Data tracked by StockTitan Argus on the day of publication.

Market Context

Against this Nu-3 safety update, the record shows earlier positive catalysts often met with weakness...

Analysis

Against this Nu-3 safety update, the record shows earlier positive catalysts often met with weakness, and SEC filings still flag going-concern risk and capital needs. With reported short interest low, attention may stay on financing progress and Phase 2a execution milestones.

Key Figures

Nu-3 gel concentration: 2% Nu-3 gel concentration: 5% Nu-3 gel concentration: 10%

3 metrics

Nu-3 gel concentration 2% Dose level targeted for evaluation in upcoming Phase 2a trial

Nu-3 gel concentration 5% Dose level targeted for evaluation in upcoming Phase 2a trial

Nu-3 gel concentration 10% Dose level targeted for evaluation in upcoming Phase 2a trial

Historical Context

5 past events · Latest: Jul 07 (Positive)

Pattern 5 events

Date	Event	Sentiment	24h Move	Catalyst
Jul 07	Policy support statement	Positive	-12.8%	Company backed the PASTEUR Act and highlighted Nu-3 Phase 2 preparation.
Jun 25	Investigator appointment	Positive	-7.8%	Named David G. Armstrong as Study Chair for Nu-3 Phase 2a iDFU trial.
Jun 22	Patent grant	Positive	-7.2%	Secured Australian composition of matter patent for Bisphosphocin compounds.
Jun 16	Investor presentation	Positive	-0.7%	Announced participation in Life Sciences Virtual Investor Forum to discuss Nu-3.
May 27	IP portfolio expansion	Positive	+3.0%	Added Australia and New Zealand patents, bringing Nu-3 gel patents to 27.

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

Pattern Detected

Recent positive Nu-3 and IP updates have often been followed by negative next-day moves, indicating a tendency for the stock to fade good news.

Key Terms

diabetic foot ulcers, phase 2a, broad-spectrum, therapeutic index, +2 more

6 terms

diabetic foot ulcers medical

"targeting the topical treatment of infected diabetic foot ulcers"

A diabetic foot ulcer is an open sore or wound on the foot that occurs when high blood sugar and nerve damage prevent normal healing, much like a small pothole that keeps widening because the road can’t be properly repaired. It matters to investors because these wounds drive demand for treatments, medical devices, wound-care drugs and hospital services, and they carry risks of infection and amputation that can shape healthcare costs, reimbursement decisions and clinical trial opportunities.

phase 2a medical

"upcoming Phase 2a clinical trial"

Phase 2a is an early stage in testing a new medical treatment or drug, where the main goal is to assess its safety and find the right dosage. For investors, this stage indicates whether the treatment shows initial promise before moving on to larger, more definitive studies; progress here can influence expectations for future development and potential success.

broad-spectrum medical

"a novel class of potent, fast-acting, broad-spectrum antimicrobials"

A broad-spectrum product is a drug or treatment designed to work against a wide variety of disease-causing organisms or multiple subtypes of a condition rather than targeting a single species or strain. For investors, broad-spectrum approaches can mean a larger potential market, faster clinical adoption because precise diagnosis may be less critical, but also higher regulatory scrutiny and competition; think of it like a universal remote that controls many devices instead of one specific model.

therapeutic index medical

"gives us confidence in the therapeutic index of Nu-3"

The therapeutic index is a measure of a drug’s safety margin—the gap between the dose that produces a desired effect and the dose that causes harmful effects. For investors, a larger therapeutic index means a wider safety cushion, lower risk of dangerous side effects, smoother regulatory review and broader market acceptance, all of which can reduce clinical and commercial risk and affect a drug developer’s valuation.

systemic side effects medical

"low likelihood of producing systemic side effects"

Adverse reactions that affect the whole body or multiple organs rather than just the area where a treatment is applied; they occur when a drug or therapy enters the bloodstream or triggers widespread biological responses. Investors care because systemic side effects influence a product's safety profile, regulatory review, labeling, potential liability, and patient or physician acceptance—factors that can materially affect sales, market access, and a company’s valuation.

biofilms medical

"activity against highly resistant bacterial strains and complex biofilms"

Dense communities of bacteria or other microbes that stick to surfaces and produce a protective, glue-like layer; think of the slimy plaque on teeth or barnacles on a ship hull. They matter to investors because biofilms are harder to treat or remove than single microbes, raising costs and regulatory hurdles for medical devices, drugs, and sanitation products, and creating potential liability or market opportunity for companies that prevent or break them down.

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

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Nu-3 is a gel formulation of a Bisphosphocin® compound targeting the topical treatment of infected diabetic foot ulcers with low likelihood of producing systemic side effects.

SARASOTA, Fla., July 15, 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 robust preclinical safety data that establishes a strong foundation for clinical dose selection in its upcoming Phase 2a clinical trial.

"These preclinical results are highly encouraging, providing evidence that our Nu-3 gel formulation has the potential to be a safe and effective, topically delivered antimicrobial," said Kelvin Cooper, Ph.D., Chief Executive Officer of Lakewood-Amedex Biotherapeutics. "Safety data confirms that Nu-3 was well-tolerated and did not inhibit wound-healing in the safety study, which gives us confidence in the therapeutic index of Nu-3 as we near the expected initiation of our Phase 2a study."

Nu-3 was well tolerated in the FDA-required safety study after administering dose levels substantially higher than the doses selected for the planned Phase 2a trial. Additionally, systemic exposure was very low, as anticipated, suggesting a low potential for systemic side effects.

Lakewood-Amedex Biotherapeutics is finalizing preparation of a Phase 2a clinical trial in infected diabetic foot ulcers (iDFU). The combined outcomes of in vitro antimicrobial activity and in vivo activity in animal models of wound infection, as well as the positive safety study outcome, supports the dose selection of 2%, 5%, and 10% gels targeted for evaluation in the upcoming Phase 2a trial.

"Based on the preclinical data, including the safety study, the gel formulation of Nu-3 has the potential to be uniquely suited for the treatment of infected diabetic foot ulcers with broad-spectrum efficacy, fast-acting antimicrobial activity, as well as activity against highly resistant bacterial strains and complex biofilms," stated Thomas Balzer, M.D., Ph.D., Chief Medical Officer of Lakewood-Amedex Biotherapeutics. "The selected concentrations are expected to provide sufficient dose response information both for the antimicrobial activity in patients as well as safety and tolerability of Nu-3, as a topical formulation that ensures a localized therapeutic impact with a low risk of systemic side effects."

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

View original content to download multimedia:https://www.prnewswire.com/news-releases/lakewood-amedex-biotherapeutics-announces-preclinical-safety-data-supporting-clinical-dose-selection-for-upcoming-phase-2a-trial-of-nu-3-gel-302825779.html

SOURCE Lakewood-Amedex Biotherapeutics Inc.

FAQ

What did Lakewood-Amedex Biotherapeutics (NASDAQ: LABT) announce about Nu-3 gel on July 15, 2026?

Lakewood-Amedex Biotherapeutics announced preclinical safety data supporting clinical dose selection for its Nu-3 gel Phase 2a trial. According to Lakewood-Amedex Biotherapeutics, Nu-3 was well tolerated, showed very low systemic exposure, and did not inhibit wound healing, guiding selection of 2%, 5%, and 10% gels.

What is Nu-3 gel and how is it intended to treat infected diabetic foot ulcers (LABT)?

Nu-3 gel is a topical formulation of a Bisphosphocin® antimicrobial targeting infected diabetic foot ulcers. According to Lakewood-Amedex Biotherapeutics, it aims to provide broad-spectrum, fast-acting activity, including against highly resistant bacteria and complex biofilms, while maintaining low systemic exposure and localized therapeutic impact.

Which Nu-3 gel dose levels were selected for the upcoming Phase 2a trial in iDFU for LABT?

The company selected 2%, 5%, and 10% Nu-3 gel concentrations for its planned Phase 2a iDFU trial. According to Lakewood-Amedex Biotherapeutics, these doses should provide meaningful dose-response information on antimicrobial activity, safety, and tolerability in patients with infected diabetic foot ulcers.

How did the preclinical safety study support Nu-3 gel dose selection for Lakewood-Amedex Biotherapeutics (LABT)?

The preclinical safety study showed Nu-3 was well tolerated at doses higher than those planned for Phase 2a. According to Lakewood-Amedex Biotherapeutics, the study also found very low systemic exposure and no negative impact on wound healing, supporting the selected clinical dose range.

Does Nu-3 gel show low risk of systemic side effects according to Lakewood-Amedex Biotherapeutics (LABT)?

Yes, Nu-3 gel showed very low systemic exposure in the preclinical safety study, suggesting low systemic side-effect potential. According to Lakewood-Amedex Biotherapeutics, its topical formulation is designed to deliver localized therapeutic impact while minimizing systemic drug levels and related safety concerns.

What makes Nu-3 gel potentially suited for treating infected diabetic foot ulcers for LABT investors?

Nu-3 gel may be well suited for infected diabetic foot ulcers due to its broad-spectrum, fast-acting antimicrobial profile. According to Lakewood-Amedex Biotherapeutics, it also demonstrated activity against highly resistant bacteria and biofilms, with preclinical data indicating good tolerability and low systemic exposure.