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Press release content from PR Newswire. The AP news staff was not involved in its creation.

Emmaus Life Sciences Provides Form 10-K Filing Update

April 15, 2021 GMT
(PRNewsfoto/Emmaus Life Sciences, Inc.)
(PRNewsfoto/Emmaus Life Sciences, Inc.)

TORRANCE, Calif., April 15, 2021 /PRNewswire/ -- Emmaus Life Sciences, Inc. (OTC: EMMA), a commercial-stage biopharmaceutical company and leader in the treatment of sickle cell disease, announced today that its Audit Committee will meet the week of April 19 to review and approve the filing of the company’s 2020 Annual Report on Form 10-K and related earnings release. Due to the additional time required to complete the auditors’ review process, Emmaus will be unable to file its 2020 Form 10-K with the Securities and Exchange Commission (“SEC”) by April 15, 2021 as previously indicated in the company’s Form NT 10-K filed with the SEC on March 31, 2021. Emmaus expects to issue a press release on the company’s 2020 operating results and file its 2020 Form 10-K shortly following the Audit Committee meeting.

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“While it has taken longer than we had hoped to complete our 2020 audit and file our 2020 10-K, we are nevertheless confident about the results of the thorough and robust audit process,” said Dr. Yutaka Niihara, M.D., M.P.H., Chairman and Chief Executive Officer. “We appreciate the patience shown by our stockholders and look forward to filing our 2020 10-K and sharing our 2020 operating results.”

About Emmaus Life Sciences

Emmaus Life Sciences, Inc. is a commercial-stage biopharmaceutical company engaged in the discovery, development, marketing and sale of innovative treatments and therapies, including those in the rare and orphan disease categories. For more information, please visit www.emmausmedical.com.

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

Indication (U.S.) - Endari® is indicated to reduce the acute complications of sickle cell disease in adult and pediatric patients five years of age and older.

Important Safety Information

The most common adverse reactions (incidence >10 percent) in clinical studies were constipation, nausea, headache, abdominal pain, cough, pain in extremities, back pain, and chest pain.

Adverse reactions leading to treatment discontinuation included one case each of hypersplenism, abdominal pain, dyspepsia, burning sensation, and hot flash.

The safety and efficacy of Endari® in pediatric patients with sickle cell disease younger than five years of age has not been established.

For more information, please see full Prescribing Information of Endari® at: www.EndariRx.com/PI.

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About Sickle Cell Disease

Sickle cell disease is an inherited blood disorder characterized by the production of an altered form of hemoglobin which polymerizes and becomes fibrous, causing red blood cells to become rigid and change form so that they appear sickle shaped instead of soft and rounded. Patients with sickle cell disease suffer from debilitating episodes of sickle cell crises, which occur when the rigid, adhesive and inflexible red blood cells occlude blood vessels. Sickle cell crises cause excruciating pain as a result of insufficient oxygen being delivered to tissue, referred to as tissue ischemia, and inflammation. These events may lead to organ damage, stroke, pulmonary complications, skin ulceration, infection and a variety of other adverse outcomes. Sickle cell disease is a significant unmet medical need, affecting approximately one hundred thousand patients in the U.S. and millions worldwide, the majority of which are of African descent. An estimated 1-in-365 African American children are born with sickle cell disease.

Forward-looking Statements

This press release contains forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, as amended, including statements regarding the Company’s business and operations and future financial results. These forward-looking statements are subject to numerous assumptions, risks and uncertainties which change over time, including the risk factors disclosed in the Company’s 2019 Annual Report on Form 10-K and other reports filed with the SEC, and actual results may differ materially. Such forward-looking statements speak only as of the date they are made, and Emmaus assumes no duty to update them, except as may be required by law.

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SOURCE Emmaus Life Sciences, Inc.