Lakewood-Amedex Biotherapeutics CEO Issues Letter to Shareholders Highlighting Transformational Progress and Outlook for Nu-3

Clinical and Corporate Highlights

• Successfully listed on the Nasdaq Capital Market under the ticker symbol LABT, marking a significant milestone in the Company's evolution
• Strengthened balance sheet through completion of a $7.5 million private placement to support continued clinical advancement
• Reported positive preclinical safety and tolerability data supporting dose selection for the upcoming Phase 2a clinical trial evaluating Nu-3 Gel in infected diabetic foot ulcers (iDFUs)
• Announced internationally recognized diabetic foot expert David G. Armstrong, DPM, MD, Ph.D., as Study Chair and Scientific Advisor for the Phase 2a clinical program
• Expanded global intellectual property portfolio with a new Australian composition-of-matter patent, bringing the Company's IP portfolio to 72 granted patents and 29 pending patents
• Continued to demonstrate Nu-3's differentiated antimicrobial profile, including rapid broad-spectrum activity against multidrug-resistant pathogens without generating resistance in comparative preclinical studies

SARASOTA, Fla., Sept. 21, 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 that Kelvin Cooper, Ph.D., Chief Executive Officer of Lakewood-Amedex Biotherapeutics, has issued a Letter to Shareholders highlighting the Company's recent clinical, corporate and financial achievements and outlook as it advances Nu-3 into Phase 2 clinical development. The full text of the letter follows.

A MESSAGE FROM OUR CHIEF EXECUTIVE OFFICER

To our shareholders,

The second quarter of 2026 represented a transformational period in the evolution of Lakewood-Amedex Biotherapeutics. We successfully transitioned to a Nasdaq-listed public company, significantly strengthened our financial position and continued to advance Nu-3 toward an important clinical milestone. Together, these achievements have placed Lakewood-Amedex Biotherapeutics in what we believe is the strongest position in its history to demonstrate the potential of Nu-3 and the broader Bisphosphocin^® platform.

The opportunity before us is significant. Antimicrobial resistance continues to diminish the effectiveness of conventional antibiotics, while patients with serious infections such as infected diabetic foot ulcers face limited treatment options and potentially devastating consequences. Our Bisphosphocin^® technology was designed to address this challenge through an entirely different approach to treating bacterial infections, and we believe Nu-3 has the potential to demonstrate the clinical utility of this differentiated technology. The progress achieved over the past several months has brought us closer to realizing that opportunity.

Advancing Nu-3 Toward an Important Clinical Inflection Point

Our foremost development priority is Nu-3, our topical gel Bisphosphocin^® candidate for the treatment of infected diabetic foot ulcers. We are preparing to initiate the Phase 2a clinical trial, an important milestone that will provide the opportunity to further evaluate Nu-3 in patients and generate clinical evidence supporting its potential as a differentiated treatment for iDFUs.

Over the past several months, we have taken important steps to position the program for successful trial initiation. We reported positive preclinical safety and tolerability findings, demonstrating low systemic exposure following topical administration and confirming that Nu-3 did not interfere with the natural wound-healing process. These results supported the selection of 2%, 5% and 10% dose strengths for evaluation in the Phase 2a trial and complement Nu-3's demonstrated rapid, broad-spectrum bactericidal activity against multidrug-resistant pathogens.

We have also assembled experienced clinical leadership to support the trial. David G. Armstrong, DPM, MD, Ph.D., an internationally recognized authority in diabetic foot care, wound healing, and limb preservation, is serving as Study Chair and Scientific Advisor. The study is being led by Professional Education and Research Institute (PERI), a clinical research organization led by Charles M. Zelen, DPM, a renowned diabetic foot and wound-care expert with extensive experience conducting clinical research in this patient population.

Together, the scientific foundation established for Nu-3, the completion of key preclinical work, and the expertise supporting the Phase 2a program have positioned us to enter what we believe will be a critical stage in Nu-3's development. We look forward to initiating the trial and beginning to generate the clinical evidence needed to demonstrate Nu-3's potential for patients with infected diabetic foot ulcers.

Building a Broader Antimicrobial Platform

We believe successful clinical development of Nu-3 could not only advance a differentiated treatment for infected diabetic foot ulcers, but also provide important validation of the broader Bisphosphocin^® platform and its potential to address other serious infectious diseases where antimicrobial resistance has limited existing treatment options.

Protecting that opportunity remains an important strategic priority. Our global intellectual property portfolio now includes 72 granted patents and 29 pending patent applications worldwide, providing what we believe is a strong foundation for the long-term development and potential commercialization of our proprietary technology.

A Stronger Financial and Corporate Foundation

Our clinical progress has been accompanied by equally important advances in our corporate and financial position.

On April 23, 2026, Lakewood-Amedex Biotherapeutics successfully listed its common stock on the Nasdaq Capital Market under the ticker symbol LABT. Immediately prior to the listing, we completed a private placement of Series C Convertible Preferred Stock that generated approximately $7.5 million in gross proceeds.

Together with the automatic conversion of our outstanding preferred stock and convertible notes in connection with the Nasdaq listing, these transactions improved our liquidity, reduced current liabilities and simplified our capital structure. We believe our existing cash resources are sufficient to support our currently planned operating activities as we continue advancing Nu-3 through clinical development.

Becoming a Nasdaq-listed company also provides Lakewood-Amedex Biotherapeutics with greater visibility and broader access to the public capital markets, creating an important foundation as we pursue our clinical and strategic objectives.

In April we raised $7.5 million by selling Series C convertible preferred stock to one institutional investor. At the same time, our earlier preferred stock and convertible notes converted into common stock, leaving one class of common stock and this one series of preferred. Of the 937,500 preferred shares we issued, 486,260 have already converted into common stock and 451,240 remain. The remaining shares convert at the lower of $10.00 or 80% of the lowest closing price over the prior five trading days, with a floor of $1.00 per share. Because the floor did not adjust in our June reverse split, the maximum number of common shares the holder can receive is 4,512,400, and fewer at higher prices. On September 18 we filed a registration statement covering those shares so the holder can complete its exit. The holder cannot own more than 4.99% of our common stock at any time, so conversions and sales happen in stages rather than all at once. When the last preferred share converts, Lakewood-Amedex will have no preferred stock outstanding and no preferred dividend. We will tell you when that happens.

We understand what this has meant for our shareholders. Two of our directors have spent their careers in the capital markets: Leonard DeRoma, who held senior roles at Citibank, Lehman Brothers and Barclays Capital, and Joseph Tucker, who has taken biotechnology companies public and raised more than $100 million for them. Our aim is a clean balance sheet ahead of the Phase 2a data.

At our annual meeting on September 22, we are asking shareholders to increase our authorized common shares from 12.5 million to 100 million and to give the board authority to effect a reverse split of up to 1-for-20. There is no current plan to utilize the authority of the reverse split unless the Company's stock price would require a reverse split to maintain our Nasdaq listing.

Focused on the Opportunity Ahead

As I look at Lakewood-Amedex Biotherapeutics today, I am excited by both how far we have come and the opportunity that lies ahead. We are now a Nasdaq-listed biotechnology company with an improved financial position, an extensive global intellectual property portfolio, experienced clinical leadership, and a lead clinical asset approaching an important stage of development.

Our priorities are clear: initiate and advance Nu-3 through Phase 2 clinical development, generate the clinical evidence necessary to demonstrate its potential in infected diabetic foot ulcers, and continue building the foundation for the broader development of our Bisphosphocin® platform.

We believe Nu-3 represents an important potential value driver for Lakewood-Amedex Biotherapeutics. Positive clinical results could advance a much-needed new treatment for patients while providing important validation of a technology that we believe has potential across a broader range of serious infectious diseases.

We enter this next stage with greater resources, stronger capabilities and a clearer path forward than at any previous point in our history. On behalf of the entire Lakewood-Amedex Biotherapeutics team, I want to thank our employees, clinical collaborators and shareholders for their continued confidence and support. We look forward to keeping you informed as we work to realize the significant opportunity we see ahead.

Sincerely,
Kelvin Cooper, Ph.D.
Chief Executive Officer
Lakewood-Amedex Biotherapeutics Inc.

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. 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. 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." The 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.

Contact

Investor Relations
Tiberend Strategic Advisors, Inc.
David Irish
(231) 632-0002
[email protected] 

Media Relations
Tiberend Strategic Advisors, Inc.
Casey McDonald
(646) 577-8520
[email protected] 

SOURCE Lakewood-Amedex Biotherapeutics Inc.