• Preclinical results of EL-22 from a 2022 study demonstrated physiological (serum creatine kinase level), physical (body weight change), and functional (rotarod test) improvements in the dystrophic features of mdx mice, a mouse model of Duchenne muscular dystrophy (DMD)¹.
• Elevai believes that EL-22 has the potential to treat obesity in combination with popular weight loss therapeutics, including GLP-1 receptor agonists, by preserving muscle mass while decreasing fat mass.
• Elevai plans to submit an Investigational New Drug (IND) application in 2025 that utilizes the licensed asset EL-22, previously called BLS-M22¹.

NEWPORT BEACH, Calif., May 02, 2024 (GLOBE NEWSWIRE) -- Elevai Labs, Inc. (NASDAQ: ELAB) (“Elevai” or the “Company”), today highlights results from our licensor’s 2022 preclinical studies evaluating the treatment effect of its recently in-licensed asset, EL-22. EL-22 will primarily be commercialized by Elevai Biosciences, Inc., a biopharmaceutical division of the Company focusing on the development and acquisition of cutting-edge aesthetic medicines. Based on our licensor’s 2022 preclinical data, Elevai believes that EL-22 has the potential to treat obesity in combination with GLP-1 receptor agonists by preserving muscle mass while decreasing fat mass.

“With the growing prevalence of obesity, and popularity of drugs like Ozempic and Mounjaro, we believe there is a need for a treatment option that leads to weight loss without the associated loss of muscle. Based on the preclinical data generated by our licensor, we believe that EL-22 has the potential to treat obesity while supporting and preserving existing muscle,” said Jordan R. Plews, Ph.D., Chief Executive Officer of Elevai. “EL-22 is an engineered probiotic expressing myostatin on its surface, which triggers a mucosal immune response resulting in the body’s own anti-myostatin antibodies. Myostatin has been shown to play an important role in regulating muscle and the preclinical data show potential proof-of-mechanism of EL-22 to preserve muscle fibers in mouse models of Duchenne muscular dystrophy by reducing the effects of myostatin.”

Specifically, in the preclinical studies¹:

• EL-22 showed a statistically significant increase in anti-myostatin IgG antibody concentration, where myostatin is a key negative regulator of muscle growth.
• Statistically significant decrease in creatine kinase levels, which indicates a decrease of muscle destruction.
• EL-22 administered to mdx mice, a mouse model of Duchenne muscular dystrophy, had improved physical activity and gross motor function, as demonstrated by a longer duration during rotarod tests.
  

Based on the highlighted preclinical data, Elevai believes that EL-22 has the potential to treat obesity in combination with GLP-1 by preserving muscle mass while decreasing fat mass. The Company intends to complete an IND submission in 2025 and to initiate clinical trials in the U.S. to evaluate the myostatin approach in combination with one or more GLP-1 receptor agonists in obesity.

About Elevai Labs
Elevai Labs Inc. (NASDAQ: ELAB) specializes in medical aesthetics and biopharmaceutical drug development, focusing on innovations for skin aesthetics and treatments tied to obesity and metabolic health. Driven by a commitment to scientific research, we aim to transform personal health and beauty. For more information, please visit www.elevailabs.com.

About Elevai Biosciences
Elevai Biosciences Inc., an Elevai Labs company, is a biopharmaceutical company focusing on the development and acquisition of cutting-edge aesthetic medicines. Our lead asset, EL-22, is leveraging a first-in-class engineered probiotic approach to address obesity’s pressing issue of preserving muscle while on weight loss treatments, including GLP-1 receptor agonists. For more information, please visit www.elevaibio.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

¹ Reference: Sung DK, Kim H, Park SE, Lee J, Kim JA, Park YC, Jeon HB, Chang JW, Lee J. A New Method of Myostatin Inhibition in Mice via Oral Administration of Lactobacillus casei Expressing Modified Myostatin Protein, BLS-M22, Int. J. Mol. Sci. 2022, 23, 9059. https://doi.org/10.3390/ijms23169059

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