Hypersplenism

TORRANCE, Calif., Feb. 2, 2024 /PRNewswire/ -- Emmaus Life Sciences, Inc. (OTCQX: EMMA), a leader in sickle cell disease (SCD) treatment, today announced that it has received marketing authorization from the Puerto Rico Department of Health for Endari® (L-glutamine oral powder). This approval marks a significant milestone in Emmaus' mission to improve the lives of people with SCD around the world and provides access to this important therapy for the patients living with SCD in Puerto Rico. In addition, Endari® is approved in the United States, Israel, United Arab Emirates, Kuwait, Qatar, Bahrain, and Oman. "We are thrilled to bring Endari® to Puerto Rico, where the SCD community has faced significant challenges in accessing innovative treatments," said George Sekulich, Co-President of Emmaus Life Sciences. "This approval is a testament to our commitment to working with regulatory authorities and patient advocacy groups to expand access to Endari® for all who need it." Endari® is the first FDA-approved oral glutamine therapy for the reduction of acute complications of SCD in adult and pediatric patients five years and older. Clinical studies have shown that Endari® can significantly reduce the frequency of pain crises, hospitalizations, and other acute complications of SCD. Emmaus is committed to working with healthcare providers and payers in Puerto Rico to ensure that Endari® is accessible to all eligible patients. The company is also working to raise awareness of SCD and the benefits of Endari® through educational programs for healthcare providers and patients. 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 . About Endari® (prescription grade L-glutamine oral powder) Indication - 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: . About Sickle Cell Disease There are approximately 100,000 people living with sickle cell disease (SCD) in the United States and millions more globally. The sickle gene is found in every ethnic group, not just among those of African descent; and in the United States an estimated 1-in-365 African Americans and 1-in-16,300 Hispanic Americans are born with SCD.1 The genetic mutation responsible for SCD causes an individual's red blood cells to distort into a "C" or a sickle shape, reducing their ability to transport oxygen throughout the body. These sickled red blood cells break down rapidly, become very sticky, and develop a propensity to clump together, which causes them to become stuck and cause damage within blood vessels. The result is reduced blood flow to distal organs, which leads to physical symptoms of incapacitating pain, tissue and organ damage, and early death.2 1Source: Data & Statistics on Sickle Cell Disease – National Center on Birth Defects and Developmental Disabilities, Centers for Disease Control and Prevention, December 2020. 2Source: Committee on Addressing Sickle Cell Disease – A Strategic Plan and Blueprint for Action -- National Academy of Sciences Press, 2020. 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. These forward-looking statements are subject to numerous assumptions, risks and uncertainties which change over time, including the risk that the authorization does not lead to significant sales of Endari® in Puerto Rico and uncertainties related to Emmaus' working capital and ability to carry on its existing operations and obtain needed financing and other factors previously disclosed in the company's reports filed with the Securities and Exchange Commission, 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. Company Contact: Emmaus Life Sciences, Inc. Willis Lee Co-President and Chief Operating Officer (310) 214-0065, Ext. 1130 [email protected] SOURCE Emmaus Life Sciences, Inc.

TORRANCE, Calif., Nov. 14, 2023 /PRNewswire/ -- Emmaus Life Sciences, Inc. (OTCQX: EMMA), a commercial-stage biopharmaceutical company and leader in the treatment of sickle cell disease, today reported on its financial condition and results of operations as of and for the three and nine months ended September 30, 2023. Recent Highlights "We experienced lower net revenues in the third quarter compared to the second quarter due to a shortage of finished inventory of Endari, which has been remedied, and we expect our sales to recover in this quarter. Even so, we were able to generate modest net income as we curtailed spending on activities unrelated to Endari sales," remarked Willis Lee, Chairman of the Board and Co-president of Emmaus. Financial and Operating Results Net Revenues. Net revenues for the three months and nine months ended September 30, 2023 were $5.0 million and $22.5 million, respectively, compared to $4.9 million and $12.5 million, respectively, for same periods in 2022. The increased net revenues were primarily attributable to increased net revenues from sales in the Middle East North Africa (MENA) region, as well as increased U.S. sales compared to the same periods in 2022. Operating Expenses. Total operating expenses for the three months ended September 30, 2023 were $4.8 million, compared with $5.1 million for the same period in 2022 due primarily to reduced general and administrative expenses. Total operating expenses for the nine months ended September 30, 2023 were $19.2 million, compared with $15.7 million for the same period in 2022. The increase was due to increases of $1.2 million in share-based compensation, $0.9 million in professional fees and $0.7 million in transaction costs. Income From Operations. Income from operations for the three months ended September 30, 2023 was $0.02 million, compared to a loss from operations of $0.7 million in the same period in 2022. Income from operations for the nine months ended September 30, 2023 increased to $2.2 million, compared to a loss from operations of $5.2 million for the same period last year. The increase resulted from higher new revenues in 2023 compared to 2022. Other Income (Expense). The company realized other income of $0.08 million for the three months ended September 30, 2023, compared to $0.2 million of other expense in the same period in 2022. Other expense for the nine months ended September 30, 2023 increased to $7.1 million from $5.6 million in the same period in 2022 due primarily to an increase of $1.7 million in interest expenses and a decrease of $1.1 million in change in fair value of conversion feature derivative, partially offset by a $1.9 million decrease in foreign exchange loss compared to Q3 2022. Net Income (Loss). For the quarter, the company realized net income of $0.1 million, or $0.00 per share based on approximately 53.6 million weighted average basic common shares and a net loss of $0.01 per share based on approximately 138.4 million weighted average diluted common shares. This compares to a net loss of $0.4 million, or $0.01 per share based on approximately 49.6 million weighted average basic and diluted common shares for the third quarter of 2022. The decrease in net loss was primarily attributable to the increase in income from operations and decrease in other expenses discussed above. For the nine months ended September 30, 2023, the company reported a net loss of $4.9 million, or $0.09 per share, based on approximately 52.4 million weighted average basic and diluted common shares. This compares to a net loss of $10.8 million, or $0.22 per share, based on approximately 49.4 million weighted average basic and diluted common shares for the nine months ended September 30, 2022. The decrease was primarily due to the increase in net revenues of $10.1 million, partially offset by the increase of $3.5 million in operating expenses and $1.5 million in other expenses. Liquidity and Capital Resources. At September 30, 2023, the company had cash and cash equivalents of $1.5 million, compared with $2.0 million on December 31, 2022. About Emmaus Life Sciences Emmaus Life Sciences, Inc. is a commercial-stage biopharmaceutical company and leader in the treatment of sickle cell disease. Endari® (L-glutamine oral powder), indicated to reduce the acute complications of sickle cell disease in adults and children 5 years and older, is approved for marketing in the United States, Israel, Kuwait, Qatar, the United Arab Emirates, Bahrain and Oman and is available on a named patient or early access basis in France, the Netherlands, and the Kingdom of Saudi Arabia, where Emmaus' application for marketing authorization is awaiting final action by the Saudi Food & Drug Authority. For more information, please visit . About Endari® (prescription grade L-glutamine oral powder) Endari®, Emmaus' prescription grade L-glutamine oral powder, was approved by the U.S. Food and Drug Administration (FDA) in July 2017 for treating sickle cell disease in adult and pediatric patients five years of age and older. Indication 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: . About Sickle Cell Disease There are approximately 100,000 people living with sickle cell disease (SCD) in the United States and millions more globally. The sickle gene is found in every ethnic group, not just among those of African descent; and in the United States an estimated 1-in-365 African Americans and 1-in-16,300 Hispanic Americans are born with SCD.1 The genetic mutation responsible for SCD causes an individual's red blood cells to distort into a "C" or a sickle shape, reducing their ability to transport oxygen throughout the body. These sickled red blood cells break down rapidly, become very sticky, and develop a propensity to clump together, which causes them to become stuck and cause damage within blood vessels. The result is reduced blood flow to distal organs, which leads to physical symptoms of incapacitating pain, tissue and organ damage, and early death.2 1Source: Data & Statistics on Sickle Cell Disease – National Center on Birth Defects and Developmental Disabilities, Centers for Disease Control and Prevention, December 2020. 2Source: Committee on Addressing Sickle Cell Disease – A Strategic Plan and Blueprint for Action -- National Academy of Sciences Press, 2020. 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 trend in sales in the MENA region and in the U.S. These forward-looking statements are subject to numerous assumptions, risks and uncertainties which change over time, including the company's need for related-party loans or other financing to meet its current liabilities and fund its business and operations and other factors disclosed in the company's Annual Report on Form 10-K for the year ended December 31, 2022 and most recent Quarterly Reports on Form 10-Q, 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. Company Contact: Emmaus Life Sciences, Inc. Willis Lee Chairman and Co-president (310) 214-0065, Ext. 1130 [email protected] (Financial Tables Follow) SOURCE Emmaus Life Sciences, Inc.

Principal Inventor of Endari® (L-glutamine oral powder) and Long-time Chairman and Chief Executive Officer Free to Purse New Projects Company Appoints Interim Co-Presidents to Focus on Core Business TORRANCE, Calif., Aug. 23, 2023 /PRNewswire/ -- Emmaus Life Sciences, Inc. (OTCQX: EMMA), a commercial-stage biopharmaceutical company and leader in the treatment of sickle cell disease, today reported that on August 18, 2023 the Board of Directors, including Yutaka Niihara, M.D., Ph.D, determined that Dr. Niihara would no longer serve as Chief Executive Officer of Emmaus, or as Chairman of the Board, in order to allow Dr. Niihara to pursue business opportunities in Ube, Japan and in India previously initiated by Emmaus. Dr. Niihara was the principal inventor of Endari® (L-glutamine oral powder), which is approved in the U.S. and most of the Gulf Cooperation Council countries for the treatment of sickle cell disease, and long-time the Chairman of the Board and Chief Executive Officer of Emmaus. No rights of the company have been granted to Dr. Niihara in these regards, and he remains a director of the company. Emmaus also reported that on August 21, 2023, Willis Lee, who has long served as the Chief Operating Officer and a director of the company, and George Sekulich, the company's Chief Information Officer and Senior Vice President Global Commercialization, were appointed as interim Co-Presidents of Emmaus, to serve pending the company's search for a Chief Executive Officer. "Dr. Niihara's name and reputation will forever be associated with raising awareness of sickle cell disease among medical regulators and health practitioners in the U.S. and overseas, and we thank him for his dedicated service. We intend to continue to pursue his mission of alleviating suffering among sickle cell disease patients wherever we find them," remarked Mr. Sekulich. "As interim Co-Presidents, George and I and the rest of the Emmaus team intend to focus on our core business of growing Endari sales in the U.S and in the Middle East North Africa region while evaluating possible reformulations of Endari to compete against generic versions that we expect to see beginning in 2024," remarked Mr. Lee. "In doing so, we intend to discontinue substantially all activities unrelated to Endari sales and improvements in an effort to reduce our operating costs and increase cash flow from operations," he added. About Emmaus Life Sciences Emmaus Life Sciences, Inc. is a commercial-stage biopharmaceutical company and leader in the treatment of sickle cell disease. Endari® (L-glutamine oral powder), indicated to reduce the acute complications of sickle cell disease in adults and children 5 years and older, is approved for marketing in the United States, Israel, Kuwait, Qatar, the United Arab Emirates, Bahrain and Oman and is available on a named patient or early access basis in France, the Netherlands, and the Kingdom of Saudi Arabia, where Emmaus' application for marketing authorization is awaiting final action by the Saudi Food & Drug Authority. For more information, please visit . About Endari® (prescription grade L-glutamine oral powder) Endari®, Emmaus' prescription grade L-glutamine oral powder, was approved by the U.S. Food and Drug Administration (FDA) in July 2017 for treating sickle cell disease in adult and pediatric patients five years of age and older. Indication 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: . About Sickle Cell Disease There are approximately 100,000 people living with sickle cell disease (SCD) in the United States and millions more globally. The sickle gene is found in every ethnic group, not just among those of African descent; and in the United States an estimated 1-in-365 African Americans and 1-in-16,300 Hispanic Americans are born with SCD.1 The genetic mutation responsible for SCD causes an individual's red blood cells to distort into a "C" or a sickle shape, reducing their ability to transport oxygen throughout the body. These sickled red blood cells break down rapidly, become very sticky, and develop a propensity to clump together, which causes them to become stuck and cause damage within blood vessels. The result is reduced blood flow to distal organs, which leads to physical symptoms of incapacitating pain, tissue and organ damage, and early death.2 1Source: Data & Statistics on Sickle Cell Disease – National Center on Birth Defects and Developmental Disabilities, Centers for Disease Control and Prevention, December 2020. 2Source: Committee on Addressing Sickle Cell Disease – A Strategic Plan and Blueprint for Action -- National Academy of Sciences Press, 2020. 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 changes in management and business focus of Emmaus, the possibility of eventual marketing authorization of Endari in the KSA, the possible restructuring or refinancing of our outstanding indebtedness and the ongoing need for related-party loans or other financing to meet our current liabilities and fund our business and operations. These forward-looking statements are subject to numerous assumptions, risks and uncertainties which change over time, including factors disclosed in the company's Annual Report on Form 10-K for the year ended December 31, 2022 and Quarterly Reports on Form 10-Q for the quarters ended March 31, 2023 and June 30, 2023 filed with the Securities and Exchange Commission on March 31, 2023, May 15, 2023 and August 14, 2023, respectively, 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. Company Contact: Emmaus Life Sciences, Inc. Willis Lee Co-President and Chief Operating Officer (310) 214-0065, Ext. 1130 [email protected] SOURCE Emmaus Life Sciences, Inc.