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Elevai Biosciences gears up for FDA talks on obesity drug

Published 12/09/2024, 08:08 AM
ELAB
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NEWPORT BEACH, Calif. - Elevai Labs Inc. (NASDAQ:ELAB), through its subsidiary Elevai Biosciences Inc., has announced preparations for a pre-Investigational New Drug (IND) meeting with the U.S. Food and Drug Administration (FDA) for its novel obesity treatment, EL-22. This meeting, expected in early 2025, will outline the development plan for EL-22, including any additional preclinical studies and adjustments necessary before the IND submission. According to InvestingPro data, the company maintains impressive gross profit margins of 71% and has shown strong revenue growth of 112% over the last twelve months, despite its current market capitalization of just $5.28 million.

EL-22 is a ground-breaking probiotic engineered to express myostatin, a protein known to regulate muscle mass. The treatment is designed to work in combination with GLP-1 receptor agonists, commonly used for weight loss, to mitigate muscle loss associated with rapid weight reduction. In a Phase 1 clinical trial conducted in South Korea, EL-22 was generally well tolerated and deemed safe in healthy volunteers. InvestingPro analysis suggests the stock is currently undervalued, with 12 additional exclusive insights available to subscribers.

Deniel Mero, Co-founder of Elevai Biosciences, commented on the regulatory strategy, highlighting the significance of leveraging human safety data from their Korean licensing partner to expedite the IND process in the U.S.

Elevai Biosciences aims to file the IND application in 2025, which will be a significant step towards initiating clinical trials to assess the effectiveness of EL-22 in obesity treatment. The company's focus on preserving muscle mass while promoting fat loss represents a potential advancement in obesity care.

Elevai Labs Inc. operates a diversified portfolio, including Elevai Skincare Inc., Elevai Biosciences Inc., and Elevai Research Inc., with a focus on medical aesthetics and biopharmaceutical drug development. The company's commitment to innovation is evident in its approach to tackling obesity and metabolic health issues. Financial data from InvestingPro shows the company maintains a healthy current ratio of 3.86, though it faces challenges with negative EBITDA of $4.92 million in the last twelve months.

This announcement is based on a press release statement and contains forward-looking statements regarding the development and potential efficacy of EL-22. Investors are cautioned that these statements are predictions and that actual results may differ materially. Additional information on potential risks is available in Elevai's filings with the Securities and Exchange Commission.

In other recent news, Elevai Labs Inc. has made several key moves. The pharmaceutical company announced a 1-for-200 reverse stock split, a significant change in its stock structure. The company has also adjusted its shareholder meeting quorum from a majority to a third of the voting power of outstanding shares, potentially making shareholder meetings more manageable. Elevai Labs has been granted an extension by Nasdaq to regain compliance with its minimum bid price requirement, providing the company an opportunity to continue trading on the Nasdaq Stock Market.

In addition, Elevai Labs has entered into new executive agreements with key figures and signed a Master Services Agreement with KCRN Research, Inc. to support the development of its obesity and muscle loss treatment, EL-22. The company reported promising preclinical findings for its experimental drug EL-32, which could potentially enhance muscle preservation and fat loss in obesity treatments.

Furthermore, Elevai Labs has modified its license agreement with INmune Bio (NASDAQ:INMB) Inc., secured a $200,000 unsecured credit line from NorthStrive Fund II LLP, and announced the formation of two wholly owned subsidiaries. It has also acquired exclusive licensing rights for two novel drug candidates from South Korean company MOA Life Plus Co., Ltd. These are all recent developments from Elevai Labs.

This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.

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