EX-99.1 2 d27190dex991.htm EX-99.1 EX-99.1

Exhibit 99.1

 

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Evoke Pharma Reports Third Quarter 2025 Financial Results and Provides Business Update

Entered into an Agreement to be acquired by QOL Medical

Net product sales for the third quarter of 2025 reached $4.3 million; up 61% year-over-year

Gimoti patent life for Gimoti extended through November 2038

SOLANA BEACH, Calif., November 13, 2025 (GLOBE NEWSWIRE) – Evoke Pharma, Inc. (NASDAQ: EVOK), a specialty pharmaceutical company focused on treatments for gastrointestinal (GI) disorders with an emphasis on GIMOTI® (metoclopramide) nasal spray, today reported financial results for the third quarter ended September 30, 2025, and provided a business update.

“The proposed transaction with QOL Medical reflects this progress and the strategic value we’ve built around GIMOTI and across the broader GI community,” commented Matt D’Onofrio, Chief Executive Officer of Evoke Pharma. “We are proud of the consistent execution that led to another quarter of strong sales growth, with net product sales up over 60% year-over-year,” D’Onofrio added.

Third Quarter 2025 Highlights and Recent Developments

 

   

On November 4, 2025, Evoke announced that it has entered into an agreement and plan of merger (the “Merger Agreement”) with QOL Medical, LLC (“QOL Medical”) and QOL-EOS Merger Sub, Inc. (“Merger Sub”). Pursuant to the Merger Agreement, QOL Medical, through Merger Sub, will acquire Evoke for $11.00 per share of common stock in cash at closing.

 

   

Net product sales for the third quarter of 2025 reached $4.3 million; a 61% increase year-over-year; and brought year-to-date sales to $11.1 million, a 60% increase compared to the same period in 2024.

 

   

Evoke and EVERSANA announced expanded pharmacy access through new relationships with Omnicell and Brentwood Pharmacy, enabling wider distribution through networks such as Gastro Health and OneGI.

 

   

In August 2025, Evoke received a new U.S. patent for GIMOTI (U.S. Patent No. 12,377,064), extending expected exclusivity to November 2038. The patent was officially listed in the FDA’s Orange Book later that month.

Third Quarter 2025 Financial Results

For the third quarter of 2025, net product sales were $4.3 million, compared to $2.7 million during the third quarter of 2024. Net loss was approximately $1.2 million, or ($0.45) per share, compared with a net loss of $1.3 million, or ($0.94) per share, in the same period of 2024.

For the third quarter of 2025, selling, general, and administrative expenses were approximately $5.3 million compared to $3.8 million for the third quarter of 2024. The increase was primarily due to a $1.3 million rise in marketing and Eversana profit-sharing as a result of higher net product sales, along with higher professional fees and public company costs.


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Operating expenses for the third quarter of 2025 totaled $5.4 million, compared to $3.9 million in Q3 2024.

As of September 30, 2025, Evoke had $11.6 million in cash and cash equivalents. Based on its current operating plan, the Company believes this cash balance, along with projected product revenues, will fund operations into the fourth quarter of 2026.

Proposed Transaction Update

On November 4, 2025, Evoke announced that it had entered into the Merger Agreement, pursuant to which QOL Medical’s acquisition subsidiary will commence a tender offer to acquire all outstanding shares of Evoke at a price of $11.00 per share in cash, subject to any applicable withholding taxes and without interest thereon. The transaction, which has been unanimously approved by Evoke’s Board of Directors, is expected to close in the fourth quarter of 2025, subject to customary conditions, including the tender of a majority of Evoke’s outstanding shares.

Evoke believes this transaction represents a compelling opportunity for shareholders and underscores the value created by the GIMOTI franchise. While the Company continues to focus on commercial execution in the near term, this proposed combination is expected to further enable growth potential under new leadership and investment.

About Evoke Pharma, Inc.

Evoke is a specialty pharmaceutical company focused primarily on the development of drugs to treat GI disorders and diseases. Evoke developed, commercialized and markets GIMOTI, a nasal spray formulation of metoclopramide, for the relief of symptoms associated with acute and recurrent diabetic gastroparesis in adults.

Diabetic gastroparesis is a GI disorder affecting millions of patients worldwide, in which the stomach takes too long to empty its contents resulting in serious GI symptoms as well as other systemic complications. The gastric delay caused by gastroparesis can compromise absorption of orally administered medications. Prior to FDA approval to commercially market GIMOTI, metoclopramide was only available in oral and injectable formulations and remains the only drug currently approved in the United States to treat gastroparesis.

Visit www.EvokePharma.com for more information.

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About Gimoti® (metoclopramide) nasal spray

GIMOTI is indicated for the relief of symptoms in adults with acute and recurrent diabetic gastroparesis. Important Safety Information:

WARNING: TARDIVE DYSKINESIA

 

   

Metoclopramide can cause tardive dyskinesia (TD), a serious movement disorder that is often irreversible. The risk of developing TD increases with duration of treatment and total cumulative dosage.

 

   

Discontinue GIMOTI in patients who develop signs or symptoms of TD. In some patients, symptoms may lessen or resolve after metoclopramide is stopped.

 

   

Avoid treatment with metoclopramide (all dosage forms and routes of administration) for longer than 12 weeks because of the increased risk of developing TD with longer-term use.

GIMOTI is not recommended for use in:

 

   

Pediatric patients due to the risk of developing tardive dyskinesia (TD) and other extrapyramidal symptoms as well as the risk of methemoglobinemia in neonates.

 

   

Moderate or severe hepatic impairment (Child-Pugh B or C), moderate or severe renal impairment (creatinine clearance less than 60 mL/minute), and patients concurrently using strong CYP2D6 inhibitors due to the risk of increased drug exposure and adverse reactions.

GIMOTI is contraindicated:

 

   

In patients with a history of tardive dyskinesia (TD) or a dystonic reaction to metoclopramide.

 

   

When stimulation of gastrointestinal motility might be dangerous (e.g., in the presence of gastrointestinal hemorrhage mechanical obstruction, or perforation).

 

   

In patients with pheochromocytoma or other catecholamine-releasing paragangliomas. Metoclopramide may cause a hypertensive/pheochromocytoma crisis, probably due to release of catecholamines from the tumor.

 

   

In patients with epilepsy. Metoclopramide may increase the frequency and severity of seizures.

 

   

In patients with hypersensitivity to metoclopramide. Reactions have included laryngeal and glossal angioedema and bronchospasm.


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Potential adverse reactions associated with metoclopramide include: Tardive dyskinesia (TD), other extrapyramidal effects (EPS), parkinsonism symptoms, motor restlessness, neuroleptic malignant syndrome (NMS), depression, suicidal ideation and suicide, hypertension, fluid retention, hyperprolactinemia, effects on the ability to drive and operate machinery. Most common adverse reactions (≥5%) for GIMOTI are: dysgeusia, headache, and fatigue. These are not all of the possible side effects of GIMOTI. Call your doctor for medical advice about whether you should take GIMOTI and the possible risk factors and side effects. You are encouraged to report negative side effects of prescription drugs to the FDA.

Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

Additional Information and Where to Find It

The tender offer described above has not yet commenced. This communication is not an offer to buy nor a solicitation of an offer to sell any securities of the Company. The solicitation and the offer to buy shares of the Company’s common stock will only be made pursuant to a Tender Offer Statement on Schedule TO, including an offer to purchase, a letter of transmittal and other related materials that QOL Medical and Merger Sub intend to file with the SEC. In addition, the Company will file with the SEC a Solicitation/Recommendation Statement on Schedule 14D-9 with respect to the tender offer. Once filed, investors will be able to obtain a free copy of these materials and other documents filed by QOL Medical, Merger Sub and the Company with the SEC at the website maintained by the SEC at www.sec.gov. Investors may also obtain, at no charge, any such documents filed with or furnished to the SEC by the Company under the “investor relations” section of the Company’s website at www.evokepharma.com.

INVESTORS AND SECURITY HOLDERS ARE ADVISED TO READ THESE DOCUMENTS WHEN THEY BECOME AVAILABLE, INCLUDING THE SOLICITATION/RECOMMENDATION STATEMENT ON SCHEDULE 14D-9 OF THE COMPANY AND ANY AMENDMENTS THERETO, AS WELL AS ANY OTHER DOCUMENTS RELATING TO THE TENDER OFFER AND THE MERGER THAT ARE FILED WITH THE SEC, CAREFULLY AND IN THEIR ENTIRETY PRIOR TO MAKING ANY DECISIONS WITH RESPECT TO WHETHER TO TENDER THEIR SHARES INTO THE TENDER OFFER BECAUSE THEY CONTAIN IMPORTANT INFORMATION, INCLUDING THE TERMS AND CONDITIONS OF THE TENDER OFFER.

Safe Harbor Statement

Evoke cautions you that statements included in this press release that are not a description of historical facts are forward-looking statements. In some cases, you can identify forward-looking statements by terms such as “may,” “will,” “should,” “expect,” “plan,” “anticipate,” “could,” “intend,” “target,” “project,” “contemplates,” “believes,” “estimates,” “predicts,” “potential” or “continue” or the negatives of these terms or other similar expressions. The forward-looking statements are based on Evoke’s current beliefs and expectations and include, but are not limited to: statements regarding the planned completion of the transactions contemplated by the Merger Agreement and the timing thereof; expectations regarding the benefits sought to be achieved in the transactions; extended pharmacy access and expanded distribution of GIMOTI and expected


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patent and regulatory exclusivity. The inclusion of forward-looking statements should not be regarded as a representation by the Company that any of its plans will be achieved. Actual results may differ from those set forth in this press release due to the risks and uncertainties inherent in Evoke’s business and the proposed transactions, including, without limitation: uncertainties as to the timing and completion of the tender offer and the merger; uncertainties as to the percentage of Evoke’s stockholders tendering their shares in the tender offer; the possibility that competing offers will be made; the possibility that various closing conditions for the tender offer or the merger may not be satisfied or waived; the effects of disruption caused by the transaction making it more difficult to maintain relationships with employees, collaborators, vendors and other business partners; risks related to diverting management’s attention from Evoke’s ongoing business operations; the risk that stockholder litigation in connection with the transactions contemplated by the Merger Agreement may result in significant costs of defense, indemnification and liability; Evoke and EVERSANA may not be able to successfully drive market demand for GIMOTI; Evoke’s ability to maintain intellectual property protection and regulatory exclusivity for GIMOTI; and other risks and uncertainties pertaining to Evoke’s business, including the risks and uncertainties detailed in Evoke’s periodic reports it files with the SEC, as well as the tender offer materials to be filed by QOL Medical and Merger Sub and the Solicitation/Recommendation Statement to be filed by Evoke in connection with the tender offer.

You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement and Evoke undertakes no obligation to revise or update these statements to reflect events or circumstances after the date hereof, except as required by law. This caution is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.

Investor & Media Contact:

Daniel Kontoh-Boateng

DKB Partners

Tel: 862-213-1398

dboateng@dkbpartners.net


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Evoke Pharma, Inc

Balance Sheets

 

     September 30,
2025
    December 31,
2024
 
     (Unaudited)        

Assets

    

Current assets:

    

Cash and cash equivalents

   $ 11,576,010     $ 13,596,600  

Accounts receivable, net of allowance for credit losses of $0

     3,190,486       2,420,373  

Prepaid expenses

     136,295       731,945  

Inventories

     599,908       445,081  

Other current assets

     33,708       43,898  
  

 

 

   

 

 

 

Total current assets

     15,536,407       17,237,897  

Operating lease right-of-use asset

     106,714       154,184  

Deferred offering costs

     —        120,614  

Other long-term assets

     6,312       6,312  
  

 

 

   

 

 

 

Total assets

   $ 15,649,433     $ 17,519,007  
  

 

 

   

 

 

 

Liabilities and stockholders’ equity

    

Current liabilities:

    

Accounts payable and accrued expenses

   $ 3,916,295     $ 2,341,191  

Accrued compensation

     770,915       865,650  

Operating lease liability

     65,968       59,533  

Note payable

     5,000,000       5,000,000  

Accrued interest payable

     2,487,638       2,113,665  
  

 

 

   

 

 

 

Total current liabilities

     12,240,816       10,380,039  

Operating lease liability, net of current portion

     46,381       100,958  
  

 

 

   

 

 

 

Total liabilities

     12,287,197       10,480,997  
  

 

 

   

 

 

 

Commitments and contingencies

    

Stockholders’ equity:

    

Preferred stock, $0.0001 par value; authorized shares — 5,000,000 as of September 30, 2025 and December 31, 2024; issued and outstanding shares — zero as of September 30, 2025 and December 31, 2024

     —        —   

Common stock, $0.0001 par value; authorized shares — 100,000,000 as of September 30, 2025 and December 31, 2024; issued and outstanding shares — 1,722,409 and 1,486,009 as of September 30, 2025 and December 31, 2024, respectively

     172       149  

Additional paid-in capital

     136,187,058       135,829,493  

Accumulated deficit

     (132,824,994     (128,791,632
  

 

 

   

 

 

 

Total stockholders’ equity

     3,362,236       7,038,010  
  

 

 

   

 

 

 

Total liabilities and stockholders’ equity

   $ 15,649,433     $ 17,519,007  
  

 

 

   

 

 

 


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Evoke Pharma, Inc

Statements of Operations

 

     Three Months Ended
September 30,
    Nine Months Ended September 30,  
     2025     2024     2025     2024  

Net product sales

   $ 4,283,979     $ 2,654,186     $ 11,116,279     $ 6,941,042  

Operating expenses:

        

Cost of goods sold

     101,977       104,024       311,269       238,031  

Research and development

     5,320       11,677       56,516       16,322  

Selling, general and administrative

     5,314,370       3,824,142       14,746,777       10,697,128  
  

 

 

   

 

 

   

 

 

   

 

 

 

Total operating expenses

     5,421,667       3,939,843       15,114,562       10,951,481  
  

 

 

   

 

 

   

 

 

   

 

 

 

Loss from operations

     (1,137,688     (1,285,657     (3,998,283     (4,010,439

Other income (expense):

        

Interest income

     107,507       99,294       338,894       226,353  

Interest expense

     (126,027     (126,027     (373,973     (375,342
  

 

 

   

 

 

   

 

 

   

 

 

 

Total other expense

     (18,520     (26,733     (35,079     (148,989
  

 

 

   

 

 

   

 

 

   

 

 

 

Net loss

   $ (1,156,208   $ (1,312,390   $ (4,033,362   $ (4,159,428
  

 

 

   

 

 

   

 

 

   

 

 

 

Net loss per share of common stock, basic and diluted

   $ (0.45   $ (0.94   $ (1.58   $ (3.01
  

 

 

   

 

 

   

 

 

   

 

 

 

Weighted-average shares used to compute basic and diluted net loss per share

     2,557,408       1,399,882       2,553,121       1,381,703  
  

 

 

   

 

 

   

 

 

   

 

 

 


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Evoke Pharma, Inc

Statements of Cash Flows

 

     Nine Months Ended September 30,  
     2025     2024  

Operating activities

    

Net loss

   $ (4,033,362   $ (4,159,428

Adjustments to reconcile net loss to net cash used in operating activities:

    

Stock-based compensation expense

     293,693       512,194  

Non-cash interest expense

     373,973       375,342  

Non-cash operating lease expense

     57,440       —   

Change in operating assets and liabilities:

    

Accounts receivable

     (770,113     (1,349,447

Prepaid expenses and other assets

     726,454       749,447  

Inventories

     (154,827     (11,568

Accounts payable and accrued expenses

     1,575,104       398,136  

Accrued compensation

     (94,735     (733,376

Operating lease liabilities

     (58,112     —   
  

 

 

   

 

 

 

Net cash used in operating activities

     (2,084,485     (4,218,700
  

 

 

   

 

 

 

Financing activities

    

Proceeds from February 2024 Offering

     —        6,718,211  

Payment of February 2024 Offering costs

     —        (426,293

Proceeds from March 2024 Warrant Amendment, net of issuance costs

     —        1,229,874  

Proceeds from June 2024 Warrant Amendment, net of issuance costs

     —        308,429  

Payment of August 2024 Shelf Registration Statement offering costs

     —        (15,500

Proceeds from September 2024 Exercise Price Amendment, net of issuance costs

     —        2,587,010  

Proceeds from September 2024 Warrant Amendment, net of issuance costs

     —        416,665  

Proceeds from exercise of Pre-Funded Warrants

     —        101  

Redemption of fractional shares due to reverse stock split

     —        (191

Proceeds from the issuance of common stock pursuant to the ESPP

     63,895       —   
  

 

 

   

 

 

 

Net cash provided by financing activities

     63,895       10,818,306  
  

 

 

   

 

 

 

Net (decrease) increase in cash and cash equivalents

     (2,020,590     6,599,606  
  

 

 

   

 

 

 

Cash and cash equivalents at beginning of period

     13,596,600       4,739,426  
  

 

 

   

 

 

 

Cash and cash equivalents at end of period

   $ 11,576,010     $ 11,339,032  
  

 

 

   

 

 

 

Supplemental disclosure of non-cash investing and financing activities

    

Cashless exercise of Series A Warrants and Pre-Funded Warrants

   $ 22     $ —   
  

 

 

   

 

 

 

August 2024 Shelf Registration Statement costs included in accounts payable
and accrued expenses

   $ —      $ 99,988  
  

 

 

   

 

 

 

September 2024 Exercise Price Warrant Amendment costs included in accounts
and accrued expenses

   $ —      $ 54,561  
  

 

 

   

 

 

 

September 2024 Warrant Amendment costs included in accounts payable
and accrued expenses

   $ —      $ 46,043