StockLogistics
2年前
“6:30a ET 9/28/2022 - PR Newswire
Emmaus Life Sciences Announces Collaboration with Kier (Junior) Spates to Share Personal Experience with Sickle Cell Disease and Endari(R)
Nationally Syndicated Radio Programming Will Educate and Support SCD Patients
Emmaus Life Sciences, Inc. (OTCQX: EMMA) a commercial-stage biopharmaceutical company and leader in the treatment of sickle cell disease, today announced a collaboration with the Steve Harvey Morning Show cast member Kier (Junior) Spates to share Mr. Spates' personal experience with the use of Endari(R), Emmaus' prescription L-glutamine oral powder, to treat his sickle cell disease, or SCD.
https://mma.prnewswire.com/media/1361168/Emmaus_Medical_Inc_Logo.jpg
SCD is endemic in the African American community yet remains a significant unmet healthcare need -- despite the advent of Endari -- for many possible reasons, including a historical lack of treatment options and inadequate access to primary care. As a result, many SCD sufferers are reluctant or unsure how to seek a doctor's assistance in managing their disease, leaving untreated the debilitating pain, anemia and other symptoms of the disease which lead to premature death among SCD patients as compared to the general population.
"Our collaboration with Mr. Spates will help destigmatize SCD and inform 9 million weekly listeners to Mr. Harvey's popular show, including those who with SCD, about Endari," said Yutaka Niihara, M.D., M.P.H., Chairman and Chief Executive Officer of Emmaus. "We admire and appreciate Mr. Spates' courage in living with this disease and publicly sharing his experiences and would like to extend our public thanks to Mr. Harvey and the show's producers for their cooperation."
"I've been taking Endari since April and found it to be beneficial in my treatment regime for sickle cell disease," said Mr. Spates. "Since adding Endari to my treatment protocol I have had fewer crises. After many conversations with Emmaus, I decided to become a consultant to the company because I understand firsthand how this disease devastates the Black community. I support and understand Emmaus' commitment to take a holistic approach to the treatment of sickle cell disease."
George Sekulich, Senior Vice President of Global Commercialization at Emmaus, added, "This new collaboration, like our recently announced telehealth services, is intended to reach Americans nationwide who lack information regarding available SCD treatment options such as Endari. We believe that Mr. Spates' experience will resonate with his and Mr. Harvey's audience."
About Endari(R) (prescription grade L-glutamine oral powder)
Endari(R), Emmaus' prescription grade L-glutamine oral powder, was approved by the FDA in July 2017 for treating sickle cell disease in adult and pediatric patients five years of age and older. Sales of Endari(R) began in the United States in 2018.
Indication
Endari(R) 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.
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.
“
AskMuncher
4年前
$EMMA Emmaus Life Sciences Reports Financial Results for the Six Months Ended June 30, 2021
Press Release | 09/02/2021
Emmaus Life Sciences Reports Financial Results for the Six Months Ended June 30, 2021
Company Now Current with SEC Reporting Obligations
PR Newswire
TORRANCE, Calif., Sept. 2, 2021
TORRANCE, Calif., Sept. 2, 2021 /PRNewswire/ -- Emmaus Life Sciences, Inc. (OTC: EMMA), a commercial-stage biopharmaceutical company and leader in the treatment of sickle cell disease, today announced financial results for the six months ended June 30, 2021. As a result, the company is now current in its Securities and Exchange Commission (SEC) reporting obligations.
(PRNewsfoto/Emmaus Life Sciences, Inc.)
"With the filing of our delinquent quarterly reports on Form 10-Q for 2020 and the first two quarters of 2021, we are now current and compliant with SEC requirements," said Dr. Yutaka Niihara, M.D., M.P.H., Chairman and Chief Executive Officer. "We very much appreciate the patience and support of our long-term stockholders and other investors and are now on a footing to file our future SEC reports in a timely manner."
Financial Results for the Six Months Ended June 30, 2021
Net revenues for the six months ended June 30, 2021 increased by 5% to $11.8 million compared to the same period in 2020. When compared to the first quarter of 2021, net revenues increased by 22%. The increase in net revenues in the second quarter of 2021 was primarily attributable to bulk order purchases in the second quarter and recovery from the temporary disruptions in sales related to the COVID-19 pandemic and weather-related supply chain interruptions that affected certain key customers in the first quarter of 2021.
Total operating expenses for the first half of 2021 increased by $1.3 million, or 12%, to $12.1 million from $10.8 million for the half of 2020, primarily as a result of increased selling expenses and research and development expenses of $0.5 million and $1.4 million, respectively. The increase in selling expenses was due to compensation attributable to the company's in-house sales team. The increase in research and development expenses was attributable to the Pilot/Phase 1 study of the company's prescription grade L-glutamine oral powder to treat diverticulosis and the preclinical development of the IRAK4 inhibitor, under the company's previously announced collaboration agreement with Kainos Medicine, Inc.
Operating loss for the first half of 2021 was $1.1 million compared to $0.4 million for the first half of 2020. The operating loss for the half of 2021 was attributable to the increase in operating expenses as noted above.
Net loss for the first half of 2021 was $5.9 million compared to a net loss of $4.0 million for the first half of 2020. The increase in net loss for the first half of 2021 compared to the first half of 2020 was primarily a result of increases of $1.2 million in other expenses and $0.7 million in loss from operations as discussed above.
Total net cash flow from operating, investing and financing activities decreased by $0.1 million for the first half of 2021 compared to the same period in 2020. Cash and cash equivalents were $1.7 million as of June 30, 2021 compared to $2.5 million as of December 31, 2020.
Trading and Quotation of the Company's Common Stock
The company has applied to the OTC Markets Group for the resumption of quotations of its common stock on the OTCQX tier now that it is current in its SEC reporting, which application is under review by the OTC Markets Group. In the meantime, quotes for the common stock continue to be available on the OTC Pink tier.
2021 Annual Stockholders Meeting
The company intends to hold its next Annual Stockholders Meeting in the coming months to elect directors, to vote on certain other matters and to review operating results for 2020 and the interim period in 2021.
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.emmauslifesciences.com.
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 the filing of future SEC reports. These forward-looking statements are subject to numerous assumptions, risks and uncertainties which change over time, including uncertainties and risk factors disclosed in the company's 2020 Annual Report on Form 10-K/A filed with the SEC on August 10, 2021, 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.
(Selected Condensed Consolidated Financial Data Follows)
Emmaus Life Sciences, Inc.
Condensed Consolidated Statements of Operations and Comprehensive Income (Loss)
(In thousands, except share and per share amounts)
(Unaudited)
Six Months Ended June 30
2021
2020
Revenues, Net
$11,824
$11,314
Cost of Goods Sold
866
924
Gross Profit
10,958
10,390
Operating Expenses
12,090
10,791
Loss from Operations
(1,132)
(401)
Total Other Expense
(4,975)
(3,776)
Net Loss
(6,107)
(4,177)
Comprehensive Loss
(5,172)
(3,936)
Net Loss per Share
($0.12)
($0.08)
Weighted Average Common Shares Outstanding
49,193,474
48,805,829
Emmaus Life Sciences, Inc.
Condensed Consolidated Balance Sheets
(In thousands)
As of
June 30, 2021
(Unaudited)
December 31,
2020
Assets
Current Assets:
Cash and cash equivalents
$1,671
$2,487
Accounts receivable, net
3,359
198
Inventories, net
6,543
7,087
Prepaid expenses and other current assets
1,467
1,485
Total Current Assets
13,040
11,257
Property and equipment, net
99
120
Equity method investment
17,383
15,925
Right of use assets
3,796
4,072
Investment in convertible bond
28,671
27,866
Other assets
290
296
Total Assets
$63,279
$59,536
Liabilities and Stockholders' Equity (Deficit)
Current Liabilities:
Accounts payable and accrued expenses
$6,301
$7,460
Notes payable
3,291
4,588
Convertible debentures, net of discount
--
5,480
Other current liabilities
10,921
5,854
Total Current Liabilities
20,513
23,382
Notes payable, less current portion
1500
222
Convertible notes payable
12,526
3,150
Other long-term liabilities
38,115
37,940
Total Liabilities
72,654
64,694
Stockholders' Equity (Deficit)
(9,375)
(5,158)
Total Liabilities & Stockholders' Equity (Deficit)
$63,279
$59,536
StockLogistics
4年前
https://www.otcmarkets.com/stock/EMMA/news/Emmaus-Life-Sciences-Announces-Submission-of-Marketing-Authorization-Application-to-Swissmedic-Ideogen-AG-to-Manage-Earl?id=307395
“OTC DISCLOSURE & NEWS SERVICE
Emmaus Life Sciences Announces Submission of Marketing Authorization Application to Swissmedic Ideogen, A.G. to Manage Early Access Program
Press Release | 06/15/2021
Emmaus Life Sciences Announces Submission of Marketing Authorization Application to Swissmedic Ideogen, A.G. to Manage Early Access Program
PR Newswire
TORRANCE, Calif., June 15, 2021
TORRANCE, Calif., June 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 it has received confirmation from the Swiss Agency for Therapeutic Products (Swissmedic) of Emmaus' application for Marketing Authorization (MA) for Endari® in Switzerland. Swissmedic is responsible for the authorization and supervision of therapeutic products in Switzerland. In November 2020, Swissmedic granted Endari® orphan drug status.
(PRNewsfoto/Emmaus Life Sciences, Inc.)
Swissmedic's MA review and approval process typically takes 16 to 18 months. Endari® will be available to sickle cell disease patients on an early-access basis during the review and approval process. According to the University of Zurich, there were an estimated 220 people with sickle cell disease in Switzerland in 2017 and that number is expected to increase. Endari®, Emmaus' prescription grade L-glutamine oral powder, is approved by the United States FDA and the Israeli Ministry of Health to reduce the acute complications of sickle cell disease in adult and pediatric patients five years of age and older.
"We are looking forward to Swissmedic's review of our MA application for Endari®, which represents another important step in our progress and commitment to reach and improve the lives of sickle cell disease patients internationally," said Yutaka Niihara, M.D., M.P.H., Chairman and Chief Executive Officer of Emmaus. "We will present for Swissmedic's review our study data that led to FDA approval of Endari® along with additional data and patient experience acquired since the approval."
George Sekulich, Senior Vice President of Global Commercialization of Emmaus, added, "With the Swissmedic marketing authorization approval process underway, we continue building and enhancing Emmaus' relationships with hematologists and patient advocacy groups in Switzerland to afford sickle cell disease patients access to Endari® in the most expeditious and efficient manner possible."
Murat Goker, Head of Europe of Ideogen A.G., further commented, "Sickle cell disease is an orphan disease and chronic illness with debilitating symptoms affecting the lives of 250 to 300 patients in Switzerland. The limited approved treatment options in Switzerland classify sickle cell disease as an essential unmet medical need. Ideogen has partnered up with Emmaus to initiate a managed access program and register the drug Endari to improve access to an essential therapeutic option for physicians and patients alike."
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 Ideogen A.G.
Ideogen A.G. is a Swiss pharmaceutical group with a primary focus on specialty medicines for unmet medical needs. Ideogen strives to improve patients' quality of life and physicians' access to therapeutic options via managed access programs and approved marketing authorizations in the European continent. For more information, please visit www.ideogen.com.
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.“
AskMuncher
4年前
$EMMA Emmaus Life Sciences Announces Submission of Marketing Authorization Application to Swissmedic Ideogen, A.G. to Manage Early Access Program
Press Release | 06/15/2021
Emmaus Life Sciences Announces Submission of Marketing Authorization Application to Swissmedic Ideogen, A.G. to Manage Early Access Program
PR Newswire
TORRANCE, Calif., June 15, 2021
TORRANCE, Calif., June 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 it has received confirmation from the Swiss Agency for Therapeutic Products (Swissmedic) of Emmaus' application for Marketing Authorization (MA) for Endari® in Switzerland. Swissmedic is responsible for the authorization and supervision of therapeutic products in Switzerland. In November 2020, Swissmedic granted Endari® orphan drug status.
(PRNewsfoto/Emmaus Life Sciences, Inc.)
Swissmedic's MA review and approval process typically takes 16 to 18 months. Endari® will be available to sickle cell disease patients on an early-access basis during the review and approval process. According to the University of Zurich, there were an estimated 220 people with sickle cell disease in Switzerland in 2017 and that number is expected to increase. Endari®, Emmaus' prescription grade L-glutamine oral powder, is approved by the United States FDA and the Israeli Ministry of Health to reduce the acute complications of sickle cell disease in adult and pediatric patients five years of age and older.
"We are looking forward to Swissmedic's review of our MA application for Endari®, which represents another important step in our progress and commitment to reach and improve the lives of sickle cell disease patients internationally," said Yutaka Niihara, M.D., M.P.H., Chairman and Chief Executive Officer of Emmaus. "We will present for Swissmedic's review our study data that led to FDA approval of Endari® along with additional data and patient experience acquired since the approval."
George Sekulich, Senior Vice President of Global Commercialization of Emmaus, added, "With the Swissmedic marketing authorization approval process underway, we continue building and enhancing Emmaus' relationships with hematologists and patient advocacy groups in Switzerland to afford sickle cell disease patients access to Endari® in the most expeditious and efficient manner possible."
Murat Goker, Head of Europe of Ideogen A.G., further commented, "Sickle cell disease is an orphan disease and chronic illness with debilitating symptoms affecting the lives of 250 to 300 patients in Switzerland. The limited approved treatment options in Switzerland classify sickle cell disease as an essential unmet medical need. Ideogen has partnered up with Emmaus to initiate a managed access program and register the drug Endari to improve access to an essential therapeutic option for physicians and patients alike."
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 Ideogen A.G.
Ideogen A.G. is a Swiss pharmaceutical group with a primary focus on specialty medicines for unmet medical needs. Ideogen strives to improve patients' quality of life and physicians' access to therapeutic options via managed access programs and approved marketing authorizations in the European continent. For more information, please visit www.ideogen.com.
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: www.ENDARIrx.com/PI.
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 potential patient access to Endari®. These forward-looking statements are subject to numerous assumptions, risks and uncertainties which change over time, including uncertainties relating to possible future marketing approval in Switzerland 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.
Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/emmaus-life-sciences-announces-submission-of-marketing-authorization-application-to-swissmedic-ideogen-ag-to-manage-early-access-program-301312828.html
SOURCE Emmaus Life Sciences, Inc.
Golden Cross
5年前
News - Emmaus Life Sciences Granted Patent in India for use of Pharmaceutical-grade L-glutamine in Treating Diverticulosis
Issuance by the Indian Patent Office Further Bolsters Emmaus’ International Intellectual Property Portfolio
Link
http://www.globenewswire.com/news-release/2019/10/09/1927237/0/en/Emmaus-Life-Sciences-Granted-Patent-in-India-for-use-of-Pharmaceutical-grade-L-glutamine-in-Treating-Diverticulosis.html
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October 09, 2019 07:30 ET | Source: Emmaus Life Sciences
TORRANCE, Calif., Oct. 09, 2019 (GLOBE NEWSWIRE) -- Emmaus Life Sciences, Inc. (OTCQB: EMMA), a leader in sickle cell disease treatment, announced today the allowance by the Indian Patent Office of its patent application (serial number 1255/KOLNP/2014) for methods and compositions of pharmaceutical-grade L-glutamine (PGLG) for the treatment of diverticulosis. The allowance of this application follows the issuance of corresponding patents in the United States, Europe, Japan, Australia, Mexico, China, Indonesia, South Korea and Russia. Patent applications are currently pending in various jurisdictions around the world, including Brazil.
The allowed Indian patent application reports a significant reduction in the number of intestinal diverticula, the primary indicator of diverticulosis, through the therapeutic application of PGLG. Emmaus is aware of no commercial therapies that claim an ability to reduce intestinal diverticula at the present time.
"We have seen the positive therapeutic impact of PGLG through the efficacy of our FDA approved Endari in treating sickle cell disease, and are committed to expanding its application to other indications to address a range of unmet or underserved medical needs, including the treatment of diverticulosis,” said Dr. Yutaka Niihara, M.D., M.P.H., Chairman and Chief Executive Officer of Emmaus Life Sciences. "These patents provide significant intellectual property protection as we continue to expand our research and product development efforts and related clinical studies.”
The covered invention is directed to methods and compositions for the treatment of diverticulosis. More specifically this patent is directed to compositions including PGLG or uses of such compositions in the treatment of diverticulosis. Diverticulosis refers to a condition where small pouches (i.e., diverticula) form along the colon wall of the digestive tract. Over time, these pouches can often become inflamed and infected (diverticulitis). Epidemiological studies indicate that the prevalence of this disease is increasing worldwide.
The estimated population of India is 1.34 billion people with 104 million people currently over the age of 60. Current population trends in India estimate the number of people over 60 years of age is forecasted to grow to 175 million by 2026. Furthermore, it is estimated that approximately 32% of the population over 60 years of age in India have diverticulosis indicating between 33 million and 56 million potential patients over the next seven years.
Emmaus announced the initiation of the company’s Pilot/Phase 1 clinical study of the treatment of diverticulosis with PGLG on July 8, 2019.
About Endari® (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 sickle cell disease patients younger than five years of age have not been established.
For more information, please see full Prescribing Information of Endari at: www.ENDARIrx.com/PI.
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.emmauslifesciences.com.
Forward-Looking Statements
This press release contains forward looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding plans for the development of the company’s product candidates. These forward looking statements are subject to risks and uncertainties inherent in drug development and assumptions relating to the company’s ability to continue as a going concern, including those detailed from time to time in the company’s filings with the Securities and Exchange Commission, and represent the company’s views only as of the date they are made and should not be relied upon as representing the company’s views as of any subsequent date. The company’s actual results may differ materially from those contemplated by these forward-looking statements. The company does not undertake to update any of these forward-looking statements to reflect a change in its views or events or circumstances that occur after the date of this press release except as required by law.
Company Contacts:
Emmaus Life Sciences, Inc.
Joseph (Jay) C. Sherwood III
Chief Financial Officer
(310) 214-0065 ext. 3005
jsherwood@emmauslifesciences.com
George Sekulich
Senior Vice President of Global Commercialization
(310) 214-0065 ext. 1010
gsekulich@emmauslifesciences.com
Media Contacts:
LifeSci Advisors
Bruce Mackle
(929) 469-3859
bmackle@lifesciadvisors.com
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