Lakewood-Amedex Biotherapeutics Announces Positive Preclinical Data in Urinary Tract and Pulmonary Infection Indications with Bisphosphocin® Compounds

Further development is planned to identify the most suitable Bisphosphocin candidate to advance into early clinical development.

Rhea-AI Summary

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.

Positive

• Minor pointNu-8 at 10% inhibited E. coli growth by up to 97% in rodents, versus no vehicle-control effect.
• Minor pointAerosol Bisphosphocin compounds showed pulmonary-infection activity in animals against Acinetobacter species, P. aeruginosa and A. fumigatus.
• Minor pointLaboratory UTI testing showed activity against resistant bacteria including E. coli, K. pneumoniae and P. aeruginosa.
• Minor pointLaboratory pulmonary-infection testing showed activity against resistant bacteria including H. influenzae, K. pneumoniae and P. aeruginosa.
• Minor pointBisphosphocin compounds demonstrated laboratory activity against biofilm-forming organisms.

2 minor points

• Minor point. Forward-looking: it has not happened yet and may not happen.Further development is planned to identify the most suitable candidate for early clinical development.
• Minor point. Forward-looking: it has not happened yet and may not happen.Nu-3 Phase 2a trial for mildly infected diabetic foot ulcers is ongoing; topline data expected in first quarter 2027.

Negative

• None.

Argus 15 min delay 32 alerts

-7.73% vs previous close $0.80 last price 282.1x rel. volume Open Argus

Details

Market move: LABT -7.73% vs previous close. Preclinical infection data

+20.7% Peak Tracked

-19.9% Trough Tracked

$0.73 – $1.10 Day Range

$1.90M Market Cap

On Oct 7, the day this news came out, the latest delayed price for LABT is 7.73% below the previous close. Argus tracked a peak move of +20.7% during the session. Argus tracked a trough of -19.9% from its starting point during tracking. Our momentum scanner has recorded 32 alerts for this stock so far that day. The latest delayed price is $0.80. Relative volume is exceptionally heavy at 282.1x the average.

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Key Figures

E. coli growth inhibition: Up to 97% Nu-3 Phase 2a topline: First quarter of 2027

E. coli growth inhibition

Up to 97%

Rodent UTI model; Nu-8 administered as a 10% solution, versus no effect in vehicle control

Nu-3 Phase 2a topline

First quarter of 2027

Expected data from the ongoing trial in mildly infected diabetic foot ulcers

Key Terms

intravesical administration, in vitro, biofilm, in vivo

4 terms

intravesical administration medical

"intravesical administration of the Bisphosphocin® compound Nu-8"

A medical delivery method where a liquid drug or therapy is placed directly into the urinary bladder through a thin tube (catheter) rather than taken by mouth or injected into the bloodstream. For investors, this matters because the route of administration affects how well a treatment works, the types of side effects, manufacturing and packaging needs, regulatory hurdles, and the clinical trial design—similar to putting paint directly on a wall instead of spraying the whole room.

in vitro medical

"demonstrated in vitro activity against a broad range of resistant bacteria"

In vitro describes laboratory tests performed on cells, tissues, or biological molecules outside a living body—literally “in glass,” such as in test tubes or dishes. For investors, in vitro results are an early sign that a drug or technology has a desired effect under controlled conditions, but they don’t guarantee it will work or be safe in animals or people; think of them as a prototype tested on a bench rather than in real-world use.

biofilm medical

"drug-resistant bacteria and bacterial biofilm"

A biofilm is a thin, slimy community of microbes that stick to surfaces—like a microscopic film on a pipe or a toothbrush—held together by a self-made sticky coating. Investors care because biofilms can make infections harder to treat, reduce the effectiveness of medical devices and cleaning products, and create demand for specialized drugs, diagnostics or coatings, affecting market size, regulatory risk and a company’s ability to win approvals and customers.

in vivo medical

"demonstrated in vivo activity in animal models of pulmonary infections"

In vivo describes tests or experiments performed inside a living organism, such as an animal or human, to observe how a drug, device or biological process behaves in a real, functioning body. Investors care because in vivo results reveal safety, effectiveness and possible side effects that lab tests cannot, much like road-testing a prototype car in traffic rather than only on a bench — outcomes can strongly influence regulatory approval, clinical success and a company’s valuation.

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Intravesical administration of the Bisphosphocin^® Nu-8 to rodents infected with E. coli demonstrated up to 97% inhibition of E. coli growth compared to no effect in a vehicle control group.

SARASOTA, Fla., Oct. 7, 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, today announced positive preclinical data in urinary tract infection (UTI) and pulmonary infection indications in animal models treated with Bisphosphocin^® compounds.

In an animal model of UTI, intravesical administration of the Bisphosphocin^® compound Nu-8 in rodents infected with E. coli resulted in up to 97% inhibition of E. coli growth with a 10% solution compared to no effect in a vehicle control group. In addition, the Bisphosphocin^® class has demonstrated in vitro activity against a broad range of resistant bacteria, including those frequently found in UTI such as E. coli, K. pneumoniae, and P. aeruginosa, and has also demonstrated activity against biofilm-forming organisms. Complicated UTIs, especially catheter-associated urinary tract infections (CAUTI), are frequently caused by drug-resistant bacteria and bacterial biofilm.

Bisphosphocin^® compounds, when administered as an aerosol formulation, have also demonstrated in vivo activity in animal models of pulmonary infections caused by Acinetobacter species, P. aeruginosa, and A. fumigatus. Additionally, the Bisphosphocin^® class has demonstrated in vitro activity against a broad range of resistant bacteria frequently found in pulmonary infections such as H. influenzae, K. pneumoniae, and P. aeruginosa.

Pulmonary infections, such as community acquired bronchial pneumonia (CABP), hospital acquired bronchial pneumonia (HABP), and ventilator acquired bronchial pneumonia (VABP), are frequently caused by drug resistant bacteria. In addition, patients with cystic fibrosis have recurrent bacterial and fungal lung infections with organisms such as P. aeruginosa and A. fumigatus.

"We continue to be encouraged by the performance of different members of the Bisphosphocin^® class of compounds when tested against various bacterial species, which are known to have a major impact on human health and are key contributors to the AMR crisis," said Kelvin Cooper, Ph.D., Chief Executive Officer and Senior Vice President of Research and Development at Lakewood-Amedex Biotherapeutics. "The Bisphosphocin^® class of compounds possesses key characteristics including rapid and potent antimicrobial action and broad-spectrum activity with no expected resistance development, which could make them valuable assets in fighting the AMR crisis. 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 Biotherapeutics' lead Bisphosphocin^® candidate, Nu-3 formulated as a topical gel, is being studied in an ongoing Phase 2a trial of mildly infected diabetic foot ulcers (iDFU), with topline data expected in the first quarter of 2027.

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, the potential of Bisphosphocin® compounds in urinary tract and pulmonary infection indications, plans to identify and advance a candidate into clinical development, 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, including results in animal models or in vitro studies, may not be predictive of future results or replicated in humans; 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-8 urinary tract infection study show?

Nu-8 produced up to 97% inhibition of E. coli growth in infected rodents when administered directly into the bladder as a 10% solution. The vehicle control group showed no effect. These were preclinical animal results.

When does Lakewood-Amedex expect results from its Nu-3 diabetic foot ulcer trial?

The company expects topline data in the first quarter of 2027 from its ongoing Phase 2a trial. The study evaluates Nu-3 formulated as a topical gel in mildly infected diabetic foot ulcers.