Elevai Labs Acquires Exclusive License to Two Myostatin Muscle Loss Prevention Assets with Plan to Develop in Combination with GLP-1 Obesity Treatments

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Elevai Labs has acquired exclusive rights to two myostatin muscle loss prevention assets, EL-22 and EL-32, for the treatment of obesity. EL-22 has shown promising results in preclinical trials, increasing body weight and restoring muscle damage. The company aims to combine these assets with popular GLP-1 obesity treatments to improve the standard of care for obesity patients. Elevai plans to submit an IND application in 2025 for further clinical trials in the U.S. market. The CDC reports that 42% of adults suffer from obesity, creating a large market opportunity for weight-loss medications.

The licensing agreement with MOA Life Plus Co., includes global rights excluding South Korea. The agreement involves upfront cash, equity considerations, milestone payments, and royalties based on development and sales milestones. Elevai's approach to muscle preservation while decreasing fat mass could address the current challenge of muscle loss associated with GLP-1 weight-loss drugs, offering a unique solution to the obesity epidemic.

Positive

• Elevai Labs has acquired exclusive rights to two promising myostatin muscle loss prevention assets, EL-22 and EL-32, for the treatment of obesity.

• EL-22 has demonstrated significant increase in body weight and restored muscle damage in preclinical mouse models, suggesting potential as a combination therapy with GLP-1 products to treat obesity.

• Elevai plans to submit an IND application in 2025 for further clinical trials in the U.S., indicating a commitment to advancing their product pipeline.

• The licensing agreement includes global rights excluding South Korea, providing Elevai with a significant market opportunity to develop and commercialize the assets.

• Elevai's approach to muscle preservation while decreasing fat mass offers a differentiated solution compared to existing myostatin strategies being tested in obesity.

Negative

• Weight loss from popular GLP-1 medications can lead to the loss of both fat and lean muscle mass, posing a challenge for patients and healthcare providers.

• The success of Elevai's licensed assets in clinical trials and commercialization remains uncertain, with potential risks associated with regulatory approvals and market acceptance.

• MOA is eligible to receive milestone payments and royalties based on the Company's development and sales milestones, impacting Elevai's financial obligations.

Biotech Equity Analyst

The acquisition of exclusive licensing rights by Elevai Labs for EL-22 and EL-32 represents a strategic move to enhance its product pipeline in the niche area of obesity treatment with muscle preservation. Obesity, a pressing health issue, affects a significant portion of the adult population and is linked with various comorbidities. Thus, a product offering that can effectively aid in weight loss without the adverse effect of muscle loss presents a clear competitive advantage in the market, which is estimated to grow substantially by 2030. The combination with GLP-1 obesity treatments, already gaining traction in the market, could lead to a considerable expansion for Elevai Labs. Financially, the impact of the initial cash and equity investment towards the acquisition, as well as future milestone payments and royalties, should be measured against the potential market growth and the capacity of these products to capture market share. Investors might see this as a long-term growth opportunity, with significant investments not yielding returns until after successful clinical trials and market penetration.

Pharmaceutical Market Research Analyst

As a pharmaceutical market research analyst, the focus is on the implications of Elevai's strategic partnership and the potential market disruption it could create with the novel assets EL-22 and EL-32. The pharmaceutical industry, particularly the anti-obesity segment, is ripe for innovation, especially with treatments that address the significant side effects associated with current medications. The preclinical and clinical findings Elevai touts, if validated, signify a potential paradigm shift in obesity treatment by offering a dual benefit—reducing fat mass while preserving lean muscle. Moreover, the collaboration with a South Korean firm could signify broader implications for geographical expansion and tapping into the Asian market. Given the global obesity epidemic, the market size and demand for such differentiated treatments are expected to escalate and Elevai Labs' stock market performance could positively correlate with the progress and commercialization of these assets.

Medical Research Scientist

From a scientific perspective, the targeting of myostatin as a way to counteract muscle wasting while promoting weight loss is a promising area of study. Myostatin inhibitors like EL-22 are designed to enhance muscle growth, which could be revolutionary in the treatment of conditions such as sarcopenia and cachexia, seen in chronic diseases. The planned IND submission is a critical step toward establishing efficacy and safety profiles for these drugs. However, the scientific community will be keenly observing the results of the U.S. clinical trials to understand the broader implications, such as potential immunogenicity due to the probiotic nature of the therapy and the clinical significance of mucosal immunity in the context of obesity. This research could not only impact the treatment paradigm for obesity but also influence therapies for a range of metabolic and muscular disorders.

• Agreement adds two drug candidates to product pipeline consisting of (i) “EL-22”, a clinical stage engineered probiotic expressing myostatin, and (ii) “EL-32”, a preclinical engineered probiotic expressing dual myostatin & activin-A.
  
• Exclusive license covers global rights excluding South Korea.
  
• Clinical and preclinical data supports advancing EL-22, a novel investigational myostatin asset for the treatment of obesity for an investigational new drug “IND” application in 2025. EL-22 has demonstrated significant increase in body weight and restored muscle damage in preclinical mouse models, suggesting potential as a combination to glucagon-like peptide-1 “GLP-1” products to treat obesity.

NEWPORT BEACH, Calif., May 01, 2024 (GLOBE NEWSWIRE) -- ELEVAI LABS, INC. (NASDAQ: ELAB) (the “Company”), today announced that it has entered into an exclusive licensing agreement with MOA Life Plus Co., Ltd., (“MOA”) a South Korean corporation, with the aim to develop and commercialize two novel assets for the treatment of obesity and muscle loss prevention.

The licensed assets include EL-22, a clinical stage engineered probiotic expressing myostatin, and EL-32, a preclinical engineered probiotic expressing dual myostatin & activin-A. EL-22 has completed a Phase 1 clinical trial in South Korea, demonstrating it was generally well tolerated and safe in healthy volunteers. Elevai intends to evaluate EL-22 for efficacy and safety in combination with popular weight-loss therapeutics currently on the market, with the goal of decreasing fat mass while preventing the muscle wasting that commonly occurs with weight-loss drugs.

“This license agreement represents a transformational and strategic milestone for Elevai,” said Jordan R. Plews, PhD, Co-Founder and Chief Executive Officer of the Company. “The adoption and use of other GLP-1 drugs has resulted in rapid weight loss and increases the desire for related aesthetic procedures linked to the side effects from these drugs, including significant unwanted muscle loss. We see the licensing of these two assets as an opportunity to provide an unmet need and expand into a large and growing multi-billion-dollar market.”

According to the CDC, 42% of adults suffer from obesity and could benefit from weight loss medication. Approved popular GLP-1 drugs such as Ozempic^® (semaglutide), Wegovy^® (semaglutide) or Mounjaro^® (tirzepatide) are expected to lead the anti-obesity market to $100 billion by 2030, according to Goldman Sachs Research. However, there remains a significant challenge as weight loss from the approved GLP-1 medications also results in collective loss of fat mass and lean muscle mass, which is critical for metabolism, strength, and mobility.

Based on preclinical data, Elevai believes that the assets it has licensed have the potential to significantly improve the standard of care for the treatment of obesity in combination with GLP-1 by preserving muscle mass while decreasing fat mass. The Company plans to make an IND submission in 2025 and to initiate clinical trials in the U.S. to evaluate the probiotic approach of EL-22 and EL-32 in combination with one or more GLP-1 receptor agonists in obesity.

“Myostatin is a clinically validated target that has demonstrated potential in muscle mass and strength building and is currently being tested in combination with GLP-1 weight loss drugs," said Dr. Tim Sayed, Chief Medical Officer of Elevai. "With our new additions, we believe that we have a differentiated, oral approach as compared to other myostatin strategies being tested in obesity. Our approach induces mucosal immunity through the body’s own anti-myostatin antibodies, which could have an important role in addressing the unmet medical need of obese patients, who need to preserve muscle while losing weight.”

Under the terms of the license agreement, the Company obtained global rights outside of South Korea to develop and commercialize the assets in exchange for upfront cash and equity consideration. MOA is also eligible to receive milestone payments based upon the achievement of certain of the Company’s development and sales milestones, and royalties on net sales of certain royalty-bearing products sold by Elevai and its affiliates or sublicensees.

About Elevai Labs

Elevai Labs, Inc. (NASDAQ: ELAB) is a medical aesthetics company developing cutting-edge physician-dispensed skin care applications. The Company solves unmet needs in the medical aesthetics space through a combination of cutting-edge science-driven and next-generation consumer applications. Elevai Labs develops topical aesthetic skin care cosmetic products for the physician-dispensed market, with a focus on leveraging a proprietary stem cell exosome technology. For more information visit www.elevailabs.com.

Cautionary Note Regarding Forward-Looking Statements

Statements contained in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. Words such as “believes,” “expects,” “plans,” “potential,” “would” and “future” or similar expressions such as “look forward” are intended to identify forward-looking statements. Examples of these forward-looking statements include statements concerning: Elevai’s expectations regarding its growth, strategy, progress and the design, objectives and timing of its clinical trials for EL-22; and the potential of EL-22 to treat obesity without an associated loss of muscle, both as a monotherapy and in combination with GLP-1 receptor agonists. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. These risks and uncertainties include, among others: Elevai’s limited operating history and historical losses; Elevai’s ability to raise additional funding to complete the development and any commercialization of its product candidates; Elevai’s dependence on the success of its product candidates EL-22 and EL-32; that Elevai may be delayed in initiating, enrolling or completing any clinical trials; competition from third parties that are developing products for similar uses; Elevai’s ability to obtain, maintain and protect its intellectual property; and Elevai’s dependence on third parties in connection with manufacturing, clinical trials and preclinical studies.

These and other risks are described more fully in Elevai’s filings with the Securities and Exchange Commission (“SEC”), including the “Risk Factors” section of the Company’s Annual Report on Form 10-K for the year ended December 31, 2023, filed with the SEC on March 29, 2024, and its other documents subsequently filed with or furnished to the SEC. All forward-looking statements contained in this press release speak only as of the date on which they were made. Except to the extent required by law, the Company undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.

Media & Product Contact:
Brenda Buechler, CMO
contact@elevailabs.com

Investor Relations Contact:
Tyler Troup, Circadian Group IR
IR@elevailabs.com

FAQ

What are the two myostatin muscle loss prevention assets acquired by Elevai Labs?

Elevai Labs has acquired EL-22 and EL-32 as myostatin muscle loss prevention assets for the treatment of obesity.

When does Elevai plan to submit an IND application for clinical trials in the U.S. market?

Elevai plans to submit an IND application in 2025 for further clinical trials in the U.S. market.

What market opportunity does Elevai aim to address with the licensing agreement?

Elevai aims to address the market opportunity for weight-loss medications, with 42% of adults suffering from obesity according to the CDC.

What potential challenge is associated with weight loss medications like GLP-1 drugs?

Weight loss from GLP-1 medications can result in the loss of fat mass and lean muscle mass, posing challenges for metabolism, strength, and mobility.

What financial considerations are involved in the licensing agreement between Elevai Labs and MOA?

The licensing agreement includes upfront cash, equity considerations, milestone payments, and royalties based on development and sales milestones.