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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): November 14, 2025

 

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 2.02 Results of Operation and Financial Condition.

 

On November 14, 2025, Emmaus Life Sciences, Inc. (“we,” “us,” “our,” “Emmaus” or the “company”) issued a press release announcing our results of operations and financial condition as of and for the three months ended Sseptember 30, 2025, a copy of which is included as Exhibit 99.1 to this Current Report and incorporated herein by reference.

 

The information included in this Item 2.02 and in Exhibit 99.1 shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934 (the “Exchange Act”) or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933 or the Exchange Act, except as expressly set forth by specific reference in such a filing.

 

Item 9.01 Financial Statements and Exhibits

 

(d) Exhibits

 

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

 

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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: November 14, 2025 Emmaus Life Sciences, Inc.
     
  By: /s/ WILLIS LEE
    Name:  Willis Lee
    Title: Chairman and Chief Executive Officer

 

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INDEX TO EXHIBITS

 

Exhibit
Number
  Description
99.1   November 14, 2025 Press Release
104   Cover Page Interactive Date File (embedded within Inline XBRL document)

 

 

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Exhibit 99.1

 

 

Emmaus Life Sciences Reports Quarterly Financial Results

 

Torrance CA, November 14, 2025 - Emmaus Life Sciences, Inc. (OTCQB: 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, 2025.

 

Highlights

 

“We experienced a 38% decline in net revenues for three month ended September 30, 2025 as compared to the same period in 2024 due to ongoing competition from generic L-Glutamine in the U.S. and lower sales in the Middle East North Africa, or MENA, region,” commented Willis Lee, Chairman and Chief Executive Officer of Emmaus. “We realized income from operations of $0.7 million compared to $0.8 million in the prior year partially offset by a 43% reduction in operating expenses,” he added.

 

Financial and Operating Results

 

Net Revenues. Net revenues for the three months ended September 30, 2025 were $3.4 million, compared to $5.5 million in the same period in 2024. The decrease was due to a decrease in U.S. sales which management attributes to competition from the generic version of L-Glutamine introduced in the market in mid-2024 and a decrease of sales in the MENA region, which management attributes to the timing of sales in the region.

 

Operating Expenses. Total operating expenses for the three months were $2.4 million compared to $4.3 million in the comparable period in 2024. The decrease was due primarily to decreases in selling expenses and general and administrative expenses attributable to a reduction in force and other cost cutting measures in the second half of 2024.

 

Income (Loss) From Operations. Income from operations for the three months was $0.7 million compared to $0.8 million in the same period in 2024. This was due to the decrease in net revenues, partially offset by lower operating expenses.

 

Other Income (Expense). The company realized other expense of $2.2 million for the three months compared to other income of $1.0 million in the same period in 2024. The increase in other expense was due to a decrease of $2.3 million in change in fair value of conversion feature derivative liabilities and increases in $0.6 million in interest expense and $0.3 million in loss on debt extinguishment.

 

Net Loss. For the three months, the company realized net loss of $2.1 million, or $0.03 per share based on approximately 63.9 million weighted-average basic common shares, compared to net income of $1.8 million, or $0.03 per share based on approximately 63.9 million weighted-average basic common shares in the comparable period in 2024. The increase in net loss was attributable primarily to the increase in other expense.

 

Liquidity and Capital Resources. At September 30, 2025, the company had cash and cash equivalents of $0.3 million, compared to $1.4 million at December 31, 2024.

 

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. These forward-looking statements are subject to numerous assumptions, risks and uncertainties which change over time, including doubt about the company’s ability to continue as a going concern and other factors disclosed in the company’s Annual Report on Form 10-K for the year ended December 31, 2024 filed with the SEC on April 14, 2025 and Quarterly Report on Form 10-Q filed on November 14, 2025, 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.

Investor Relations

(310) 214-0065

[email protected]

 

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(Financial Tables Follow)

 

Emmaus Life Sciences, Inc.
Condensed Consolidated Statement of Operations and Comprehensive Income (Loss)

(In thousands, except share and per share amounts)

 

   Three Months Ended September 30,   Nine Months Ended September 30, 
   2025   2024   2025   2024 
Revenues, Net  $3,378   $5,478   $8,601   $13,361 
Cost of Goods Sold   247    394    622    892 
Gross Profit   3,131    5,084    7,979    12,469 
Operating Expenses   2,436    4,263    8,634    13,806 
Income (Loss) from Operations   695    821    (655)   (1,337)
Total Other Income (Expense)   (2,192)   1,005    (4,893)   (3,345)
Net Income (Loss)   (2,076)   1,827    (5,541)   (4,705)
Comprehensive Income (Loss)   (1,720)   1,378    2,514    (1,856)
Net Income (Loss) Per Share  $(0.03)  $0.03   $(0.09)  $(0.07)
Weighted Average Common Shares Outstanding   63,865,571    63,865,571    63,865,571    63,025,296 

 

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Emmaus Life Sciences, Inc.
Condensed Consolidated Balance Sheets

(In thousands)

 

   As of 
   September 30,
2025
   December 31,
2024
 
   (Unaudited)     
Assets        
Current Assets:        
Cash and cash equivalents  $293   $1,389 
Accounts receivable, net   2,619    2,623 
Inventories, net   1,213    1,635 
Prepaid expenses and other current assets   661    1,120 
Total Current Assets   4,786    6,767 
Property and Equipment, net   128    46 
Right of use assets   799    1,530 
Investment in convertible bond   14,876    15,037 
Other Assets   167    222 
Total Assets   20,756    23,602 
           
Liabilities and Stockholders’ Deficit          
Current Liabilities:          
Accounts payable and accrued expenses   21,759    16,926 
Operating lease liabilities, current portion   348    2,423 
Conversion feature derivative, notes payable       162 
Notes payable, current portion   10,772    10,465 
Convertible notes payable, net of discount   16,804    17,014 
Other current liabilities   14,486    16,565 
Total Current Liabilities   64,169    63,555 
Other long-term liabilities   16,075    16,526 
Total Liabilities   80,244    80,081 
Stockholders’ Deficit   (59,488)   (56,479)
Total Liabilities & Stockholders’ Deficit   20,756    23,602 

 

 

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