Lakewood-Amedex Biotherapeutics Inc (LABT)

Lakewood-Amedex Expands Global IP Portfolio for Lead Candidate, Nu-3, Targeting Infected Diabetic Foot UlcersMay 27, 2026 8:02 AM
PR Newswire (US) Patent portfolio now includes 71 granted patents and 28 pending patent applications, covering composition of matter, formulation, and use patentsSARASOTA, Fla., May 27, 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 an expansion of its global intellectual property portfolio with the issuance of two patents, one each in Australia and New Zealand respectively. The two patents are directed to the gel formulation of the Bisphosphocin® Nu-3, which is being advanced into a Phase 2 clinical trial for the treatment of mildly infected diabetic foot ulcers (iDFU). The gel formulation of the topically applied Nu-3 is designed specifically to adhere to wounds and comprises lyotropic liquid crystals that form a mobile network through hydrogen bonding to water."These newly issued patents further strengthen and expand our global intellectual property portfolio surrounding the Bisphosphocin platform, which we believe is one of our company's most important strategic assets," said Kelvin Cooper, Chief Executive Officer of Lakewood-Amedex Biotherapeutics. "As we advance the development of Nu-3 and our broader pipeline of novel antimicrobial compounds, expanding our worldwide patent estate remains central to protecting our innovation, enhancing future commercial opportunities, and creating long-term shareholder value. With almost 100 granted and pending patents, we believe Lakewood-Amedex Biotherapeutics is building a strong competitive position in the fight against antimicrobial resistance."New patents directed to Bisphosphocin gel formulations:On February 3, 2026, The Intellectual Property Office of New Zealand (IPONZ) granted patent number 759577, titled, "Bisphosphocin Gel Formulations and Uses Thereof."On March 19, 2026, IP Australia granted Patent Number 2024202211, titled, "Bisphosphocin Gel Formulations and Uses Thereof."These two new patents expand the number of granted patents for the Nu-3 gel formulation to 27 patents, covering the following geographical regions - United States, European Patent Office (Austria, Belgium, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland), India, Japan, Hong Kong, Brazil, United Kingdom, New Zealand, and Australia.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.About Nu-3
Nu-3 is Lakewood-Amedex Biotherapeutics Inc.'s lead product being developed for the topical treatment of mildly infected diabetic foot ulcers (iDFU). Nu-3 belongs to a novel class of antimicrobials being developed by Lakewood-Amedex Biotherapeutics Inc. called the Bisphosphocin® class, which possess a unique mechanism of action that enables rapid elimination of a broad spectrum of bacteria, including resistant pathogens and biofilms. Data from initial exploratory clinical trials with Nu-3 using subclinical doses did not reveal any safety signals and showed a trend of positive antimicrobial response and improved wound healing. Based on these results, the Company plans to conduct an initial Phase 2a safety and dose response study of Nu-3 followed by a placebo-controlled Phase 2b dose comparative study. This study is also designed to determine the most appropriate administration regimen for Nu-3 gel formation in mildly infected diabetic foot ulcers.Forward-Looking Statements
This press release may contain forward-looking statements as defined by the Private Securities Litigation Reform Act of 1995. Generally, the words "believe," "expect," "intend," "estimate," "anticipate," "project," "will" and similar expressions identify forward-looking statements, which generally are not historical in nature. However, the absence of these words or similar expressions does not mean that a statement is not forward-looking. All statements that address operating performance, events or developments that we expect or anticipate will occur in the future are forward-looking statements. Management believes that these forward-looking statements are reasonable as and when made. However, caution should be taken not to place undue reliance on any such forward-looking statements because such statements speak only as of the date when made. Our Company undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law. In addition, forward-looking statements are subject to certain risks and uncertainties that could cause our Company's actual results to differ materially from historical experience and our present expectations or projections.Relying on such statements involves risk, uncertainty and assumptions. These statements are based on the current estimates and assumptions of the management of Lakewood-Amedex Biotherapeutics Inc. as of the date of this press release and are subject to uncertainty and changes. All statements obtained in this press release are made only as of the date of this press release and Lakewood-Amedex Biotherapeutics Inc. does not undertake any obligation to publicly update any forward-looking statements.Contact
Investor Relations
Tiberend Strategic Advisors, Inc.
David Irish
(231) 632-0002
dirish@tiberend.comMedia 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-expands-global-ip-portfolio-for-lead-candidate-nu-3-targeting-infected-diabetic-foot-ulcers-302782417.htmlSOURCE Lakewood-Amedex Biotherapeutics Inc. Original: Lakewood-Amedex Expands Global IP Portfolio for Lead Candidate, Nu-3, Targeting Infected Diabetic Foot Ulcers

Positive Nu-3 Data Advances Lakewood-Amedex Toward Phase 2 Diabetic Foot Ulcer Trial (LABT)May 18, 2026 11:20 AM
IH Market News Manufacturing progress, stability data, and formulation advances are moving Lakewood-Amedex’s lead antimicrobial candidate closer to Phase 2 testing in infected diabetic foot ulcers. Key Investor Takeaways The primary catalyst is positive Nu-3 data supporting advancement toward a planned Phase 2 clinical trial Lakewood-Amedex Biotherapeutics (NASDAQ:LABT) reported manufacturing and formulation progress for its Bisphosphocin® antimicrobial platform The company completed multikilogram cGMP manufacturing runs for both Nu-3 drug substance and gel formulation Stability testing showed Nu-3 drug substance remained stable for at least five years, while the gel formulation demonstrated two-year stability Management highlighted broader future applications for the Bisphosphocin® platform beyond diabetic foot ulcers, including urinary tract and pulmonary infections Why LABT Stock Is in Focus Lakewood-Amedex Biotherapeutics announced positive development and manufacturing data for Nu-3, its lead antimicrobial candidate targeting mildly infected diabetic foot ulcers.According to the company, it completed several multikilogram manufacturing runs for members of the Bisphosphocin® class under current Good Manufacturing Practices guidelines.The company also said it successfully manufactured multikilogram quantities of the Nu-3 gel formulation suitable for use in future clinical trials.Management noted that process improvements reduced production costs while enhancing physical chemistry characteristics of the drug substance.“Lakewood-Amedex Biotherapeutics has worked diligently to optimize formulation and manufacturing processes required to produce both the Bisphosphocin® drug substances and drug products,” said Kelvin Cooper, Ph.D., Chief Executive Officer at Lakewood-Amedex Biotherapeutics.The company reported that stability testing showed the Nu-3 drug substance remained stable for at least five years, while the final gel formulation remained stable for at least two years.Lakewood-Amedex also stated that initial antimicrobial effectiveness testing showed undetectable bioburden levels without requiring additional preservatives.Nu-3 is designed as a topical antimicrobial treatment for infected diabetic foot ulcers with a goal of reducing antimicrobial resistance risks.According to the company, the Bisphosphocin® platform demonstrated the ability in vitro to rapidly eliminate bacteria through destabilization of bacterial cell membranes, including resistant strains such as MRSA and VRE. Why This Matters for Investors The announcement may be important for investors because it shifts focus from early-stage discovery toward operational readiness for later-stage clinical development.Manufacturing scalability, formulation stability, and cGMP production capabilities are often critical hurdles for clinical-stage biotechnology companies preparing for larger trials and eventual commercialization efforts.The extended stability profile may also support future supply chain flexibility and commercial manufacturing potential if clinical development progresses successfully.Beyond diabetic foot ulcers, management is also positioning the Bisphosphocin® platform as a broader antimicrobial technology with potential applications across additional infectious disease indications.That broader platform narrative could become increasingly relevant as investors continue monitoring antimicrobial resistance and demand for alternative anti-infective therapies.However, the company remains in the clinical development stage, and Nu-3 has not yet demonstrated efficacy in larger late-stage trials.Future regulatory outcomes, clinical results, safety performance, and commercialization execution remain key uncertainties. What to Watch Next Investors may monitor: Timing and initiation of the planned Phase 2a Nu-3 clinical trial Dose-response and safety data from upcoming studies Potential expansion into additional infectious disease indications Further manufacturing scale-up and commercialization readiness updates Regulatory interactions tied to Nu-3 development and trial progression Lakewood-Amedex Biotherapeutics stock price Original: Positive Nu-3 Data Advances Lakewood-Amedex Toward Phase 2 Diabetic Foot Ulcer Trial (LABT)

Lakewood-Amedex Biotherapeutics Announces Positive Data for the Advancement of Lead Candidate, Nu-3, in Infected Diabetic Foot UlcersMay 18, 2026 8:02 AM
PR Newswire (US) Key formulation, delivery and manufacturing steps completed in preparation for planned Phase 2 clinical trial SARASOTA, Fla., May 18, 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 data for its lead compound, Nu-3, as it advances towards a Phase 2 trial. Nu-3 is being developed as a topically delivered treatment for mildly infected diabetic foot ulcers (iDFU) designed to reduce the risk of antimicrobial resistance (AMR). The Company has conducted drug substance (the active ingredient) manufacturing process development for a few members of the Bisphosphocin® class and has completed several multikilogram scale under current Good Manufacturing Practices (cGMP) guidelines with high efficiency. In addition, process development advances have improved the cost of goods and have produced bulk drug substance with enhanced physical chemistry characteristics. The Company has also conducted drug product (the gel formulation) manufacturing process development and multikilogram quantities of the Nu-3 gel formulation have been manufactured under cGMP guidelines, and the product is suitable for use in clinical trials."Lakewood-Amedex Biotherapeutics has worked diligently to optimize formulation and manufacturing processes required to produce both the Bisphosphocin® drug substances and drug products," said Kelvin Cooper, Ph.D., Chief Executive Officer at Lakewood-Amedex Biotherapeutics. "The Bisphosphocin® class of compounds are modified nucleotide molecules with excellent aqueous solubility, potentially making them adaptable to a range of different drug product formulations and delivery methods, which could have significant potential in additional indications such as complicated urinary tract infection (cUTI) and pulmonary infections. We look forward to advancing the current Nu-3 gel formulation into a planned Phase 2 clinical trial targeting iDFU."In key stability testing, the Company has shown that the Nu-3 bulk drug substance material is stable for at least five years, and further examinations of the Nu-3 formulation have shown the drug product to be stable for at least two years. In addition, initial testing for bioburden (the presence of viable microorganisms) and antimicrobial effectiveness has demonstrated that the drug product has undetectable bioburden levels for at least two years and does not require additional preservatives to maintain antimicrobial effectiveness.The Bisphosphocin® class of compounds has been shown in vitro to rapidly kill bacteria through a pH and concentration dependent destabilization of the bacterial cell membrane. This mechanism of action offers the potential to reduce the threat posed by antibiotic-resistant bacterial strains, including Methicillin-resistant Staphylococcus aureus (MRSA), Vancomycin-resistant Enterococci (VRE), and others.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.About Nu-3
Nu-3 is Lakewood-Amedex Biotherapeutics Inc.'s lead product being developed for the topical treatment of mildly infected diabetic foot ulcers (iDFU). Nu-3 belongs to a novel class of antimicrobials being developed by Lakewood-Amedex Biotherapeutics Inc. called the Bisphosphocin® class, which possess a unique mechanism of action that enables rapid elimination of a broad spectrum of bacteria, including resistant pathogens and biofilms. Data from initial exploratory clinical trials with Nu-3 using subclinical doses did not reveal any safety signals and showed a trend of positive antimicrobial response and improved wound healing. Based on these results, the Company plans to conduct an initial Phase 2a safety and dose response study of Nu-3 followed by a placebo-controlled Phase 2b dose comparative study. This study is also designed to determine the most appropriate administration regimen for Nu-3 gel formation in mildly infected diabetic foot ulcers.Forward-Looking Statements
This press release may contain forward-looking statements as defined by the Private Securities Litigation Reform Act of 1995. Generally, the words "believe," "expect," "intend," "estimate," "anticipate," "project," "will" and similar expressions identify forward-looking statements, which generally are not historical in nature. However, the absence of these words or similar expressions does not mean that a statement is not forward-looking. All statements that address operating performance, events or developments that we expect or anticipate will occur in the future are forward-looking statements. Management believes that these forward-looking statements are reasonable as and when made. However, caution should be taken not to place undue reliance on any such forward-looking statements because such statements speak only as of the date when made. Our Company undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law. In addition, forward-looking statements are subject to certain risks and uncertainties that could cause our Company's actual results to differ materially from historical experience and our present expectations or projections.Relying on such statements involves risk, uncertainty and assumptions. These statements are based on the current estimates and assumptions of the management of Lakewood-Amedex Biotherapeutics Inc. as of the date of this press release and are subject to uncertainty and changes. All statements obtained in this press release are made only as of the date of this press release and Lakewood-Amedex Biotherapeutics Inc. does not undertake any obligation to publicly update any forward-looking statements.Contact
Investor Relations
Tiberend Strategic Advisors, Inc.
David Irish
(231) 632-0002
dirish@tiberend.comMedia 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-positive-data-for-the-advancement-of-lead-candidate-nu-3-in-infected-diabetic-foot-ulcers-302773810.htmlSOURCE Lakewood-Amedex Biotherapeutics Inc. Original: Lakewood-Amedex Biotherapeutics Announces Positive Data for the Advancement of Lead Candidate, Nu-3, in Infected Diabetic Foot Ulcers

Pipeline info,phase 2 foot ulcers,coming lungs,urinarary tract,mouth,ears
https://lakewoodamedex.com/pipeline/

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https://lakewoodamedex.investorroom.com/2026-05-01-Lakewood-Amedex-Biotherapeutics-Announces-Positive-Antimicrobial-Resistance-Data-for-Lead-Candidate-Targeting-Infected-Diabetic-Foot-Ulcers

https://lakewoodamedex.com/

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