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Annual Report Filing Delayed by Emmaus Life Sciences

TORRANCE, Calif., April 15, 2024 /PRNewswire/ – Emmaus Life Sciences, Inc. (OTCQX: ), a biopharmaceutical company at the commercial stage and a pioneer in sickle cell disease treatment, has announced a delay in filing its Annual Report on Form 10-K for the year ended December 31, 2023.

The Chairman of the Board and Co-president of Emmaus, Willis Lee, stated, “Although we aimed to submit our Annual Report by today’s deadline, we are still in the process of collaborating with our independent registered public accounting firm to finalize the review of our accounting related to the disposal of our equity interest in a variable interest entity (VIE) towards the end of 2023. We expect to file the Form 10-K within the next week.”

Overview of Emmaus Life Sciences

Emmaus Life Sciences, Inc. is a leading commercial-stage biopharmaceutical company specializing in sickle cell disease treatment. Endari® (L-glutamine oral powder) is approved for marketing in several countries, including the United States, Israel, Kuwait, Qatar, the United Arab Emirates, Bahrain, and Oman. Additionally, it is accessible in France, the Netherlands, and the Kingdom of Saudi Arabia on a named patient or early access basis, with Emmaus awaiting final action by the Saudi Food & Drug Authority for marketing authorization. For more details, please visit the company website.

Endari® Description (prescription grade L-glutamine oral powder)

Endari®, a prescription-grade L-glutamine oral powder developed by Emmaus, received approval from the U.S. Food and Drug Administration (FDA) in July 2017 for managing sickle cell disease in adult and pediatric patients aged five years and above.

Medical Indication

Endari® is recommended for reducing the acute complications of sickle cell disease in adult and pediatric patients aged five years and above.

Essential Safety Information

Common adverse reactions (with an incidence exceeding 10 percent) observed in clinical trials included constipation, nausea, headache, abdominal pain, cough, pain in extremities, back pain, and chest pain. Instances of treatment discontinuation due to adverse reactions comprised hypersplenism, abdominal pain, dyspepsia, burning sensation, and hot flash, each occurring once.

The safety and effectiveness of Endari® in pediatric patients under five years with sickle cell disease have not been established.

Insight into Sickle Cell Disease

Approximately 100,000 individuals live with sickle cell disease (SCD) in the United States, with millions more affected globally. The sickle gene is present in various ethnic groups, not limited to individuals of African descent. In the U.S., an estimated 1 in 365 African Americans and 1 in 16,300 Hispanic Americans are born with SCD. The genetic anomaly responsible for SCD causes the red blood cells to deform into a sickle shape, reducing their oxygen-carrying capacity. These sickled cells deteriorate rapidly, become adhesive, and tend to clump together, leading to blockages in blood vessels and subsequent organ damage. This results in decreased blood flow to distant organs, causing severe pain, tissue damage, and premature mortality. Sources: Data & Statistics on Sickle Cell Disease – National Center on Birth Defects and Developmental Disabilities, Centers for Disease Control and Prevention, December 2020; Committee on Addressing Sickle Cell Disease – A Strategic Plan and Blueprint for Action – National Academy of Sciences Press, 2020.

Forward-thinking Statements

This press release includes forward-looking statements in compliance with the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, as amended. These statements, including those regarding the expected filing of the company’s Annual Report on Form 10-K for the year ended December 31, 2023, may differ from actual results. All forward-looking statements are valid only as of their publication date, and Emmaus disclaims any obligation to update them, except as required by law.

Company Contact:

Emmaus Life Sciences, Inc.

Willis Lee

Chairman and Co-president

(310) 214-0065, Ext. 1130

SOURCE Emmaus Life Sciences, Inc.