EMMA Emmaus Life Sciences Inc (QX)

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

FORM 8-K

 

CURRENT REPORT

 

Pursuant to Section 13 OR 15(d) of the Securities Exchange Act of 1934

 

Date of Report (Date of earliest event reported): August 18, 2023

 

Emmaus Life Sciences, Inc.

(Exact name of registrant as specified in its charter)

 

Delaware		001-35527		87-0419387
(State or other jurisdiction of incorporation)		(Commission File Number)		(I.R.S. Employer Identification No.)

 

21250 Hawthorne Boulevard, Suite 800, Torrance, CA		90503
(Address of principal executive offices)		(Zip Code)

 

Registrant’s telephone number, including area code (310) 214-0065

  

 

(Former name or former address, if changed, since last report.)

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

 

☐

Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

☐

Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

☐

Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

☐

Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13a-4(c))

 

Securities registered pursuant to Section 12(b) of the Act: 

 

Title of each class		Trading Symbol		Name of each exchange on which registered
None

 

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

 

Emerging growth company ☐

 

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

 

  

Item 5.02 Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers

 

On August 23, 2023, Emmaus Life Sciences, Inc. (“we,” “us,” “our,” “Emmaus” or the “company”) issued a press release regarding changes in our senior management. A copy of the press release is included as Exhibit 99.1 to this Current Report and incorporated herein by reference.

  

Among other things, the press release reported that Willis Lee and George Sekulich have been appointed as interim Co-Presidents of Emmaus. Mr. Lee’s compensation as Co-President will not change from his compensation as our Chief Operating Officer as described in the “Executive Compensation” section beginning on page 60 of the company’s Annual Report on Form 10-K filed with the Securities and Exchange Commission on March 31, 2023, which description is incorporated herein by reference. Mr. Sekulich is currently entitled to a base annual salary of $210,000 and as an officer of the company is eligible for periodic awards under our 2021 Stock Incentive Plan.

 

Item 9.01 Financial Statements and Exhibits

 

(d) Exhibits

 

See the accompanying Index to Exhibits, which information is incorporated herein by reference.

 

 

SIGNATURES

 

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

Date: August 23, 2023	Emmaus Life Sciences, Inc.
	By:	/s/ YASUSHI NAGASAKI
		Name:	Yasushi Nagasaki
		Title:	Chief Financial Officer

 

 

INDEX TO EXHIBITS

 

Exhibit Number		Description
99.1		Press release dated August 23, 2023
104		Cover Page Interactive Date File (embedded within Inline XBRL document)

 

 

 

 

 

 

 

 

Exhibit 99.1

 

 

Emmaus Life Sciences Reports Management Changes

 

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 CA, August 23, 2023 - 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 www.emmausmedical.com.

 

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: 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.

 

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

wlee@emmauslifesciences.com

 

 

 

 

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