Lakewood-Amedex Biotherapeutics Announces Agreement with PERI to Serve as CRO for Phase 2 Clinical Trial of Nu-3

Rhea-AI Summary

Lakewood-Amedex Biotherapeutics (NASDAQ: LABT) signed an agreement with Professional Education and Research Institute (PERI) to act as CRO for the Phase 2 clinical program of Nu-3, a Bisphosphocin antimicrobial for mildly infected diabetic foot ulcers (iDFU).

The program starts with a single-blinded Phase 2a study testing 2%, 5% and 10% gel concentrations, followed by a planned Phase 2b study comparing different dosing regimens versus placebo in this large, underserved market.

Positive

• PERI appointed as CRO for Nu-3 Phase 2 clinical program
• Phase 2a trial to evaluate 2%, 5% and 10% Nu-3 gel
• Planned Phase 2b study to compare once-daily and twice-daily dosing versus placebo
• CRO brings established wound care and podiatry network to support recruitment and data quality

Negative

• None.

News Market Reaction – LABT

+1.90%

3 alerts

+1.90% Session close to close

-10.6% Trough Tracked

$23.22M Market Cap

0.0x Rel. Volume

In the May 12 session, LABT gained 1.90%, reflecting a mild positive market reaction. Argus tracked a trough of -10.6% from its starting point during tracking. Our momentum scanner triggered 3 alerts that day, indicating moderate trading interest and price volatility.

Data tracked by StockTitan Argus on the day of publication.

Market Context

This announcement advances Nu-3 into a PERI-supported Phase 2 program for infected diabetic foot ulc...

Analysis

This announcement advances Nu-3 into a PERI-supported Phase 2 program for infected diabetic foot ulcers, moving from non-clinical data toward human proof of concept at 2%, 5%, and 10% gel concentrations. Prior Nu-3 antimicrobial resistance results and recent board additions frame a building development story. Investors may watch for Phase 2 enrollment progress, safety and efficacy readouts, and how future updates interact with the company’s previously disclosed financial position and capital needs.

Key Figures

Trial phase: Phase 2 Phase 2a design: Single-blinded Nu-3 gel doses: 2%, 5% and 10% +5 more

8 metrics

Trial phase Phase 2 Upcoming Nu-3 clinical program in iDFU

Phase 2a design Single-blinded Initial human proof-of-concept study for Nu-3

Nu-3 gel doses 2%, 5% and 10% Phase 2a concentration arms in iDFU trial

Phase 2b frequency Once-a-day or twice-a-day Dosing regimens vs placebo in Phase 2b

Current price $3.16 Pre-news market price on 2026-05-12

52-week range $2.58–$9.82 Positioned 22.48% above low and 67.82% below high

Market cap $44,393,135 Equity value prior to Phase 2 CRO announcement

Daily price change 1.94% 24h move ahead of Phase 2 Nu-3 news

Historical Context

2 past events · Latest: May 01 (Positive)

Pattern 2 events

Date	Event	Sentiment	24h Move	Catalyst
May 01	Nu-3 AMR data	Positive	+28.9%	Reported positive in vitro antimicrobial resistance data for Nu-3 in iDFU.
Apr 28	Board appointment	Positive	+6.3%	Appointed Joseph Tucker, Ph.D., to Board to bolster strategic oversight.

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

Pattern Detected

Positive Nu-3 updates and governance news have recently coincided with strong upward price reactions.

Recent Company History

Over recent weeks, Lakewood-Amedex highlighted Nu-3’s profile and strengthened governance. On Apr 28, 2026, the company added Joseph Tucker, Ph.D., to the Board, which corresponded with a 6.28% gain. On May 1, 2026, positive in vitro antimicrobial resistance data for Nu-3 targeting iDFU coincided with a 28.95% move. Today’s announcement that Nu-3 is progressing into a PERI-supported Phase 2 program fits this pattern of incremental development for the Bisphosphocin platform in diabetic foot ulcers.

Key Terms

contract research organization, cro, phase 2, in vitro, +4 more

8 terms

contract research organization technical

"to serve as the contract research organization (CRO) for its upcoming Phase 2"

A contract research organization (CRO) is an outside company hired to run medical and scientific work for drug, device or biotech developers—like an experienced project manager and lab team that companies rent instead of building in-house. Investors care because CROs influence development speed, quality and cost: delays or successes in trials affect client spending, regulatory risk and ultimately revenues for both the sponsor and the CRO.

cro technical

"Professional Education and Research Institute LLC (PERI) to serve as the contract research organization (CRO)"

CRO stands for Contract Research Organization, a company that helps pharmaceutical and biotech firms manage and carry out clinical trials to test new medicines. For investors, CROs are important because they enable drug companies to develop new treatments more efficiently, potentially accelerating the path to market and affecting the company's growth prospects and success.

phase 2 medical

"serve as the CRO for its upcoming Phase 2 clinical program of Nu-3"

Phase 2 is the mid-stage clinical trial where a new drug or treatment is tested in a larger group of patients to see if it works and to keep checking safety after initial human testing. Think of it as a field test that proves whether a product actually delivers its promised benefit. Investors watch Phase 2 closely because its results strongly influence a medicine’s chances of reaching the market, the size of its potential sales, and the company’s valuation.

in vitro medical

"based on available non-clinical in vitro and in vivo data"

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.

in vivo medical

"based on available non-clinical in vitro and in vivo data"

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.

biofilms medical

"rapid elimination of a broad spectrum of bacteria, including resistant pathogens and 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.

placebo medical

"treatments in comparison to placebo"

A placebo is an inactive pill, injection or procedure that looks and feels like the real treatment but contains no therapeutic ingredient, often called a sugar pill. Investors care because comparing a drug to a placebo reveals whether observed benefits come from the medicine itself or from expectation; clear superiority over placebo reduces regulatory and commercial risk, much like a blind taste test proves a new recipe really tastes better.

antibiotic-resistant medical

"address the growing global challenge of antibiotic-resistant infections"

Antibiotic-resistant describes bacteria that have evolved or acquired ways to survive treatment with one or more antibiotics that once killed them. Like weeds that no longer respond to a garden spray, resistant infections can make existing drugs ineffective, increasing treatment costs, driving demand for new medicines and diagnostics, and raising regulatory, liability and public-health risks that can affect healthcare providers, drug developers and insurers.

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

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Specialized CRO partnership supports Phase 2 program to advance Nu-3 toward potential registration pathway in large, underserved iDFU market

SARASOTA, Fla., May 12, 2026 /PRNewswire/ -- Lakewood-Amedex Biotherapeutics Inc., (NASDAQ: LABT), a clinical-stage biotechnology company advancing a novel class of potent, fast-acting, broad-spectrum antimicrobials for locally treatable infectious diseases called the Bisphosphocin^® class, today announced that it has entered into an agreement with Professional Education and Research Institute LLC (PERI) to serve as the contract research organization (CRO) for its upcoming Phase 2 clinical program of Nu-3, the Company's lead Bisphosphocin^® product for the treatment of mildly infected diabetic foot ulcers (iDFU). Nu-3 belongs to a novel class of antimicrobials (Bisphosphocin^®) possessing a unique mechanism of action that enables rapid elimination of a broad spectrum of bacteria, including resistant pathogens and biofilms, based on available non-clinical in vitro and in vivo data.

The selection of PERI reflects strategic alignment with a CRO that has a strong track record in wound care and podiatric medicine. Founded by Charles Zelen, DPM, FACFAS, a practicing podiatrist with deep ties to the diabetic foot care community, PERI brings a unique combination of clinical insight, investigator relationships, and operational expertise in managing studies within this patient population. The organization's established network of investigators and access to relevant clinical sites is expected to support efficient patient recruitment and high-quality data generation.

"Advancing Nu-3 into a Phase 2 clinical trial represents a critical step forward in our mission to address the growing global challenge of antibiotic-resistant infections," said Thomas Balzer, M.D., Ph.D., Chief Medical Officer of Lakewood-Amedex Biotherapeutics. "We are pleased to partner with PERI, whose deep expertise in wound care and diabetic foot ulcers, combined with strong clinical execution capabilities, makes them an ideal collaborator for this important study."

The planned Phase 2 program is designed to evaluate the safety and efficacy of Nu-3 in patients with iDFU, a serious and prevalent complication of diabetes that is associated with high morbidity, risk of amputation, and significant healthcare costs. The program will begin with a single-blinded Phase 2a study comparing 2%, 5% and 10% gel concentrations to establish initial proof of concept in humans. Following this, the program is expected to advance to a Phase 2b study, evaluating different gel-concentrations of Nu-3 as either once-a-day or twice-a-day treatments in comparison to placebo.

"We are excited to collaborate with Lakewood-Amedex on the advancement of Nu-3," said Dr. Zelen. "As a clinician treating patients with diabetic foot ulcers, I recognize the urgent need for new, effective and local therapies that can control infection and assist healing of the wound. Nu-3's novel mechanism and targeted approach have the potential to make a meaningful impact for patients and providers."

Infected diabetic foot ulcers 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 an early stage. The emergence of antibiotic-resistant pathogens has further complicated treatment, underscoring the need for innovative therapeutic options such as Nu-3.

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 PERI
Professional Education and Research Institute LLC (PERI) is a midsize contract research organization specializing in the design and execution of clinical trials in wound care and podiatry, among other therapeutic areas. The company leverages deep clinical expertise, strong investigator relationships, and a focused operational model to deliver high-quality clinical research services. PERI was founded by Charles Zelen, DPM, FACFAS, an active practicing podiatrist with extensive experience in the treatment of 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.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

What did Lakewood-Amedex (NASDAQ: LABT) announce about Nu-3 on May 12, 2026?

Lakewood-Amedex announced an agreement with PERI to serve as CRO for the Phase 2 Nu-3 clinical program in infected diabetic foot ulcers. According to Lakewood-Amedex, this partnership supports advancing Nu-3 toward a potential registration pathway in a large, underserved iDFU market.

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

Nu-3 is a Bisphosphocin antimicrobial gel being developed for mildly infected diabetic foot ulcers. According to Lakewood-Amedex, Nu-3 has a novel mechanism of action and has shown rapid elimination of a broad spectrum of bacteria, including resistant pathogens and biofilms, in non-clinical studies.

How is the Phase 2 clinical program of Nu-3 in iDFU designed?

The Nu-3 Phase 2 program begins with a single-blinded Phase 2a study testing 2%, 5% and 10% gel concentrations. According to Lakewood-Amedex, a subsequent Phase 2b trial is expected to evaluate different gel concentrations once or twice daily compared with placebo.

What role will PERI play as CRO in Lakewood-Amedex’s Nu-3 Phase 2 trial?

PERI will act as the contract research organization for the Nu-3 Phase 2 clinical program in iDFU. According to Lakewood-Amedex, PERI contributes wound care expertise, investigator relationships, and site access to support efficient patient enrollment and high-quality data generation.

Why is the Nu-3 Phase 2 trial important for patients with infected diabetic foot ulcers?

The Nu-3 Phase 2 trial targets a serious complication of diabetes associated with high morbidity, amputation risk, and healthcare costs. According to Lakewood-Amedex, antibiotic resistance has complicated treatment, underscoring the need for new, local therapies like Nu-3 to control infection and aid healing.

What unmet medical need in iDFU is Lakewood-Amedex (LABT) aiming to address with Nu-3?

Nu-3 aims to address infected diabetic foot ulcers, which affect millions worldwide and can lead to hospitalization or amputation. According to Lakewood-Amedex, current options are challenged by antibiotic-resistant pathogens, creating demand for innovative, locally applied antimicrobial treatments such as Nu-3.