NEWPORT BEACH, Calif. - Elevai Biosciences Inc., part of Elevai Labs Inc. (NASDAQ: ELAB), is advancing its efforts to seek regulatory approval for a new obesity treatment, EL-22, by engaging with KCRN Research, Inc. The company announced its plans to prepare for an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) slated for 2025.
EL-22 is a novel myostatin asset designed to work alongside existing GLP-1 medicines, commonly used for weight loss, which often result in muscle wasting as a side effect. As no current treatments address this issue, EL-22 aims to preserve muscle mass while aiding in fat reduction.
The partnership with KCRN Research, a global contract research organization, will focus on bridging the regulatory gap for Korean-originated assets like EL-22 and preparing early phase drug development projects for FDA submission. The collaboration will include development work required for the IND submission and scheduling a pre-IND meeting with the FDA to discuss the path forward for EL-22.
Deniel Mero, Co-founder of Elevai Biosciences, expressed optimism about the myostatin approach, which has shown promise in preclinical trials. A 2022 study demonstrated that EL-22 led to physiological, physical, and functional improvements in a mouse model of Duchenne muscular dystrophy.
EL-22 offers a differentiated, oral approach compared to other injectable myostatin strategies being tested in obesity. The mechanism is believed to induce mucosal immunity through the body's own anti-myostatin antibodies, potentially offering a new treatment option for obesity in combination with GLP-1 receptor agonists.
Hugh Lee, CEO & Founder of KCRN, echoed the sentiment, highlighting the potential of EL-22 to provide a solution for GLP-1 patients needing a way to preserve muscle.
Elevai Labs Inc. specializes in medical aesthetics and biopharmaceutical drug development, with a focus on skin aesthetics and treatments for obesity and metabolic health. Its subsidiary, Elevai Biosciences, is at the forefront of developing cutting-edge aesthetic medicines.
This announcement contains forward-looking statements regarding the potential of EL-22 and the company's future plans. These statements are based on current beliefs and expectations and are subject to inherent uncertainties and risks. Investors are cautioned that actual results may differ from those anticipated.
The information presented here is based on a press release statement from Elevai Labs Inc.
In other recent news, Elevai Labs has made substantial progress in its various ventures. The company has demonstrated promising preclinical findings for its experimental drug EL-32, which may enhance muscle preservation and fat loss in obesity treatments. Elevai has also filed two patent applications for its lead candidate, EL-22, targeting muscle loss in obese patients. The company has initiated a clinical study to evaluate the efficacy of their exosome-based skincare products and has priced its public offering at $8 million.
Elevai Labs has also released findings suggesting its exosome-based products may enhance the effects of laser therapy in treating melasma. The company has reported promising results from a hair restoration study and filed two patents for new hair and scalp care technology in collaboration with Yuva Biosciences. Furthermore, Elevai Labs has reported positive results from a skincare study using its product, Elevai enfinity™, indicating significant improvement in various skin appearance metrics.
On the corporate side, Elevai Labs has modified its license agreement with INmune Bio Inc., secured a $200,000 unsecured credit line from NorthStrive Fund II LLP, and announced the formation of two wholly owned subsidiaries. The company has acquired exclusive licensing rights for two novel drug candidates from South Korean company MOA Life Plus Co., Ltd., and entered into an exclusive distribution agreement with ILIA International Ltd. for its exosome-based skincare products in Taiwan. These are the recent developments from Elevai Labs.
InvestingPro Insights
As Elevai Biosciences Inc. (NASDAQ: ELAB) embarks on its journey to seek FDA approval for EL-22, its novel obesity treatment, investors should consider some key financial metrics and insights from InvestingPro.
Despite the company's ambitious plans, InvestingPro data reveals that Elevai Labs Inc. has a modest market capitalization of $4.89 million. This small-cap status underscores the speculative nature of the investment, particularly given the company's focus on early-stage drug development.
InvestingPro Tips highlight that Elevai Labs is "quickly burning through cash" and is "not profitable over the last twelve months." These factors are not uncommon for biotech companies in the research and development phase, but they emphasize the importance of successful regulatory milestones, such as the planned IND application for EL-22 in 2025.
On a positive note, the company has shown impressive revenue growth, with InvestingPro data indicating a 140.04% increase in the last twelve months as of Q2 2024. This growth aligns with the company's progress in its medical aesthetics and biopharmaceutical segments.
However, investors should be aware that the stock "has fared poorly over the last month" and "has taken a big hit over the last six months," according to InvestingPro Tips. The stock's price has fallen significantly, with a -97.09% total return over the past year.
For those considering an investment in Elevai Labs, it's worth noting that InvestingPro offers 13 additional tips for ELAB, providing a more comprehensive analysis of the company's financial health and market position.
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