Emmaus Life Scie Stock Price, News & Analysis

Emmaus Life Sciences, Inc. (OTC: EMMA) announced a restatement of financial statements for the fiscal year ending December 31, 2020. Investors should disregard previous financial data from the Annual Report filed on May 4, 2021. The amended report shows a net income increase to $1.4 million, up from $1.1 million originally reported, reflecting improved performance in their equity method investment. The company is also working to file overdue quarterly reports to avoid a trading suspension.

Emmaus Life Sciences (OTC: EMMA) reported preliminary sales results for the six months ending June 30, 2021. In Q2 2021, the company shipped 6,880 boxes of its sickle cell disease treatment, Endari, marking a 21% rise from 5,690 boxes in Q1 2021, which was affected by severe weather. However, total sales volume for the first half of 2021 remained unchanged compared to the same period in 2020. Emmaus plans to release complete interim financial results in the upcoming Forms 10-Q.

Emmaus Life Sciences, Inc. (OTC: EMMA) has submitted its Marketing Authorization application for Endari® to the Kuwait Drug and Food Control (KDFC) as of July 15, 2021. This application aims to register Endari®, an oral powder for treating sickle cell disease, which is already FDA-approved for patients aged five and older. The KDFC has agreed to a fast-track review expected to conclude within twelve months. Though only around 500 patients suffer from sickle cell disease in Kuwait, Endari® will be available for early access during the review period, addressing a critical medical need.

Emmaus Life Sciences (OTC: EMMA) announced that it received confirmation from Swissmedic for its Marketing Authorization application for Endari® in Switzerland. This application follows the orphan drug status granted in November 2020. The review typically takes 16 to 18 months, during which Endari® will be available on an early-access basis. Endari® is FDA-approved and indicated for reducing complications of sickle cell disease. Approximately 220 patients are affected by sickle cell disease in Switzerland, with increasing numbers expected.

Emmaus Life Sciences (OTC: EMMA) announced that its Marketing Authorization application for Endari® has been accepted by the Saudi Food and Drug Authority. The review process is expected to take 12 to 18 months. Endari®, a prescription L-glutamine oral powder, treats sickle cell disease, which affects 1.4% of Saudi Arabia's population, equating to approximately 225,000 potential patients in the MENA region. The company will provide early access to Endari® during the approval phase to meet urgent medical needs.

Emmaus Life Sciences (OTC: EMMA) reported a 2% increase in net revenues to $23.2 million for 2020, despite challenges from the COVID-19 pandemic. The company's operating expenses dropped by $5.2 million to $21 million, resulting in an operating loss of just $32,000 compared to $4.5 million in 2019. Net income improved dramatically to $1.1 million from a net loss of $54.8 million. Emmaus is optimistic about future growth with its product Endari® and ongoing trials.

Emmaus Life Sciences (OTC: EMMA) announced it will delay filing its 2020 Annual Report on Form 10-K, initially due on April 15, 2021. The Audit Committee is scheduled to meet the week of April 19 to review the report and approve its filing. The additional time is needed to complete the audit process. Emmaus plans to release its 2020 operating results shortly after the meeting. CEO Dr. Yutaka Niihara expressed confidence in the audit process and appreciation for shareholders' patience.

Emmaus Life Sciences (OTC: EMMA) has entered a collaboration with Kainos Medicine to spearhead the preclinical development of Kainos' IRAK4 inhibitor (KM10544) as an anti-cancer treatment. The partnership includes a $500,000 cash payment and an equivalent in Emmaus common stock, granting Emmaus rights for potential exclusive licensing of resulting intellectual property. This inhibitor targets malignancies with MYD88 mutations, indicating significant medical and commercial potential. Emmaus has previously reported net revenues of $22.8 million in 2019.

Emmaus Life Sciences (OTC: EMMA) announced on October 14, 2020, that it has sold its remaining shares in Telcon RF Pharmaceutical Inc. for KRW 42 billion (approximately $36.6 million). Following the sale, Emmaus will lend KRW 30 billion (approximately $26.1 million) to Telcon via a convertible bond, which will replace the sold shares as collateral. This transaction aims to eliminate the volatility from Telcon shares and may facilitate a potential up-listing to NASDAQ or NYSE American. Proceeds will be used for working capital.