0000950170-25-108411.txt : 20250814 0000950170-25-108411.hdr.sgml : 20250814 20250814070528 ACCESSION NUMBER: 0000950170-25-108411 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 12 CONFORMED PERIOD OF REPORT: 20250814 ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20250814 DATE AS OF CHANGE: 20250814 FILER: COMPANY DATA: COMPANY CONFORMED NAME: Evoke Pharma Inc CENTRAL INDEX KEY: 0001403708 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] ORGANIZATION NAME: 03 Life Sciences EIN: 208447886 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-36075 FILM NUMBER: 251214251 BUSINESS ADDRESS: STREET 1: 420 STEVENS AVENUE STREET 2: SUITE 230 CITY: SOLANA BEACH STATE: CA ZIP: 92075 BUSINESS PHONE: 858-345-1494 MAIL ADDRESS: STREET 1: 420 STEVENS AVENUE STREET 2: SUITE 230 CITY: SOLANA BEACH STATE: CA ZIP: 92075 8-K 1 evok-20250814.htm 8-K 8-K
0001403708false00014037082025-08-142025-08-14

 

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 14, 2025

 

 

EVOKE PHARMA, INC.

(Exact name of Registrant as Specified in Its Charter)

 

 

Delaware

001-36075

20-8447886

(State or Other Jurisdiction
of Incorporation)

(Commission File Number)

(IRS Employer
Identification No.)

 

 

 

 

 

420 Stevens Avenue, Suite 230

 

Solana Beach, California

 

92075

(Address of Principal Executive Offices)

 

(Zip Code)

 

Registrant’s Telephone Number, Including Area Code: 858 345-1494

 

 

(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 240.13e-4(c))

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


Title of each class

 

Trading
Symbol(s)

 


Name of each exchange on which registered

Common Stock, par value $0.0001 per share

 

EVOK

 

The Nasdaq Stock Market

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 Operations and Financial Condition.

On August 14, 2025, Evoke Pharma, Inc. issued a press release announcing its financial results for the three and six-month periods ended June 30, 2025. A copy of the press release is attached hereto as Exhibit 99.1 and is incorporated herein by reference.

 

In accordance with General Instruction B.2 of Form 8-K, the information in this Current Report on Form 8-K, including Exhibit 99.1, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (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, as amended, or the Exchange Act, whether made before or after the date hereof, except as expressly set forth by specific reference in such filing.

 

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits

 

 

 

Exhibit No.

Description

99.1

Press Release issued on August 14, 2025

104

Cover Page Interactive Data File (embedded within the Inline XBRL document)

 


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.

 

 

 

EVOKE PHARMA, INC.

 

 

 

 

Date:

August 14, 2025

By:

/s/ Matthew J. D'Onofrio

 

 

 

Name: Matthew J. D'Onofrio
Title: Chief Executive Officer and Director

 


EX-99.1 2 evok-ex99_1.htm EX-99.1 EX-99.1

 

 

img208171256_0.jpg

 

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

Q2 2025 Net Product Sales Increased 47% Year-over-Year to $3.8 Million

SOLANA BEACH, Calif., August 14, 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 second quarter ended June 30, 2025, and provided a business update.

“This quarter's results demonstrate the commercial strength of GIMOTI and the precision of our execution,” said Matt D’Onofrio, Chief Executive Officer of Evoke Pharma. “With 47% year-over-year growth in net product sales and a 20% increase in new prescribers since the second quarter of last year, demand is accelerating from both physicians and patients. Fill rates are improving, and prescriber adoption is broadening across GI practices — signals that GIMOTI is becoming an essential option in the treatment of diabetic gastroparesis.”

Second Quarter 2025 Highlights and Recent Developments

Net product sales increased 47% year-over-year to $3.8 million, compared to $2.6 million in Q2 2024, reflecting expanded pharmacy access and increased physician adoption.
New prescribers grew 20% year-over-year, continuing a positive trend of clinical adoption within gastroenterology practices.
Refill rates held steady at approximately 70%, reflecting what we believe is a consistent therapeutic benefit.
Presented real-world safety data at Digestive Disease Week (DDW) 2025, comparing incidence of tardive dyskinesia among continuous versus intermittent metoclopramide use.

Second Quarter 2025 Financial Results

For the second quarter of 2025, net product sales were approximately $3.8 million compared to $2.6 million during the second quarter of 2024. Net loss was approximately $1.6 million, or ($0.62) per share, in the second quarter of 2025 compared with $1.3 million, or ($0.93) per share, during the same period in 2024.

For the second quarter of 2025, selling, general, and administrative expenses were approximately $5.1 million compared to $3.7 million for the second quarter of 2024. The increase was due to higher profit-sharing activity with EVERSANA as a result of an increase in net product sales and higher professional fees.

Total operating expenses for the second quarter of 2025 were approximately $5.3 million compared to $3.8 million for the same period in 2024.

As of June 30, 2025, cash and cash equivalents were approximately $12.1 million. We believe, based on our current operating plan, that our existing cash and cash equivalents, as well as future cash flows from net product sales of GIMOTI, will be sufficient to fund our operations into the third quarter of 2026.

2025 Revenue Outlook

Evoke is confirming its full-year 2025 net product sales guidance of approximately $16 million, representing up to a 60% increase over 2024. This guidance reflects Evoke’s current business outlook, including recent trends in prescription growth and refill rates, expanded

 

 


 

 

pharmacy access, and the continued adoption of GIMOTI. The estimate also incorporates assumptions around payer reimbursements and conversion rates, as well as external factors that remain outside of our control, including macroeconomic conditions, geopolitical volatility, supply chain constraints, and inflationary pressures.

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.

Follow Evoke Pharma on LinkedIn
Follow Evoke Pharma on
Twitter

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.

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.

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.

These statements are based on the company’s current beliefs and expectations. These forward-looking statements include statements regarding: guidance regarding 2025 net product sales; demand for GIMOTI from physicians and patients; the ongoing relevance of GIMOTI for the treatment of diabetic gastroparesis; and Evoke’s expected cash runway. The inclusion of forward-looking statements should not be regarded as a representation by Evoke 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, including, without limitation: Evoke may not be able to achieve its guidance for 2025 including as a result of decreased demand for GIMOTI; Evoke’s and EVERSANA’s ability to successfully drive market demand for GIMOTI; Evoke’s ability to obtain additional financing as needed to support its operations; Evoke may use its capital resources sooner than expected; EVERSANA may terminate the commercial services agreement and loan agreement which would require us to repay the outstanding principal and interest underlying our loan agreement with EVERSANA; Evoke’s dependence on third parties for the manufacture of GIMOTI; Evoke is entirely dependent on the success of GIMOTI; inadequate efficacy or unexpected adverse side effects relating to GIMOTI that could result in recalls or product liability claims; Evoke’s ability to maintain intellectual property protection for GIMOTI; and other risks and uncertainties detailed in Evoke’s prior press releases and in the periodic reports it files with the Securities and Exchange Commission. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and Evoke undertakes no obligation to revise or update this press release to reflect events or circumstances after the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement. 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

 

 

 

 

 

 

 

 

 

 


 

 

Evoke Pharma, Inc.

Balance Sheets

 

 

 

 

 

 

June 30,

 

 

December 31,

 

 

 

2025

 

 

2024

 

 

 

(Unaudited)

 

 

 

 

Assets

 

 

 

 

 

 

Current assets:

 

 

 

 

 

 

Cash and cash equivalents

 

$

12,059,072

 

 

$

13,596,600

 

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

 

 

2,905,443

 

 

 

2,420,373

 

Prepaid expenses

 

 

288,572

 

 

 

731,945

 

Inventories

 

 

641,872

 

 

 

445,081

 

Other current assets

 

 

36,119

 

 

 

43,898

 

Total current assets

 

 

15,931,078

 

 

 

17,237,897

 

Operating lease right-of-use asset

 

 

122,938

 

 

 

154,184

 

Deferred offering costs

 

 

 

 

 

120,614

 

Other long-term assets

 

 

6,312

 

 

 

6,312

 

Total assets

 

$

16,060,328

 

 

$

17,519,007

 

Liabilities and stockholdersʼ equity

 

 

 

 

 

 

Current liabilities:

 

 

 

 

 

 

Accounts payable and accrued expenses

 

$

3,588,290

 

 

$

2,341,191

 

Accrued compensation

 

 

607,139

 

 

 

865,650

 

Operating lease liability

 

 

63,769

 

 

 

59,533

 

Note payable

 

 

5,000,000

 

 

 

5,000,000

 

Accrued interest payable

 

 

2,361,610

 

 

 

2,113,665

 

Total current liabilities

 

 

11,620,808

 

 

 

10,380,039

 

Operating lease liability, net of current portion

 

 

65,028

 

 

 

100,958

 

Total liabilities

 

 

11,685,836

 

 

 

10,480,997

 

Commitments and contingencies

 

 

 

 

 

 

Stockholdersʼ equity:

 

 

 

 

 

 

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

 

 

 

 

 

 

Common stock, $0.0001 par value; authorized shares — 100,000,000 and
   50,000,000 as of June 30, 2025 and December 31, 2024, respectively;
   issued and outstanding shares — 1,492,858 and 1,486,009 as of
   June 30, 2025 and December 31, 2024, respectively

 

 

149

 

 

 

149

 

Additional paid-in capital

 

 

136,043,129

 

 

 

135,829,493

 

Accumulated deficit

 

 

(131,668,786

)

 

 

(128,791,632

)

Total stockholdersʼ equity

 

 

4,374,492

 

 

 

7,038,010

 

Total liabilities and stockholdersʼ equity

 

$

16,060,328

 

 

$

17,519,007

 

 

 

 

 

 


 

 

Evoke Pharma, Inc.

Statements of Operations

 

 

 

Three Months Ended June 30,

 

 

Six Months Ended June 30,

 

 

 

2025

 

 

2024

 

 

2025

 

 

2024

 

Net product sales

 

$

3,752,142

 

 

$

2,551,366

 

 

$

6,832,300

 

 

$

4,286,856

 

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

 

Cost of goods sold

 

 

167,679

 

 

 

41,478

 

 

 

209,292

 

 

 

134,007

 

Research and development

 

 

8,413

 

 

 

 

 

 

51,196

 

 

 

4,645

 

Selling, general and administrative

 

 

5,134,902

 

 

 

3,733,450

 

 

 

9,432,407

 

 

 

6,872,986

 

Total operating expenses

 

 

5,310,994

 

 

 

3,774,928

 

 

 

9,692,895

 

 

 

7,011,638

 

Loss from operations

 

 

(1,558,852

)

 

 

(1,223,562

)

 

 

(2,860,595

)

 

 

(2,724,782

)

Other income (expense):

 

 

 

 

 

 

 

 

 

 

 

 

Interest income

 

 

112,534

 

 

 

81,001

 

 

 

231,386

 

 

 

127,059

 

Interest expense

 

 

(124,658

)

 

 

(124,657

)

 

 

(247,945

)

 

 

(249,315

)

Total other expense

 

 

(12,124

)

 

 

(43,656

)

 

 

(16,559

)

 

 

(122,256

)

Net loss

 

$

(1,570,976

)

 

$

(1,267,218

)

 

$

(2,877,154

)

 

$

(2,847,038

)

Net loss per share of common stock, basic and diluted

 

$

(0.62

)

 

$

(0.93

)

 

$

(1.13

)

 

$

(2.69

)

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

 

 

2,553,174

 

 

 

1,363,525

 

 

 

2,550,941

 

 

 

1,060,166

 

 

 

 

 


 

 

Evoke Pharma, Inc.

Statements of Cash Flows

 

 

 

Six Months Ended June 30,

 

 

 

2025

 

 

2024

 

Operating activities

 

 

 

 

 

 

Net loss

 

$

(2,877,154

)

 

$

(2,847,038

)

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

 

 

 

 

 

 

Stock-based compensation expense

 

 

188,637

 

 

 

380,607

 

Non-cash interest expense

 

 

247,945

 

 

 

249,315

 

Non-cash operating lease expense

 

 

38,294

 

 

 

 

Change in operating assets and liabilities:

 

 

 

 

 

 

Accounts receivable

 

 

(485,070

)

 

 

(1,329,932

)

Prepaid expenses and other assets

 

 

571,766

 

 

 

521,961

 

Inventories

 

 

(196,791

)

 

 

(62,925

)

Accounts payable and accrued expenses

 

 

1,247,099

 

 

 

586,220

 

Accrued compensation

 

 

(258,511

)

 

 

(898,213

)

Operating lease liabilities

 

 

(38,742

)

 

 

 

Net cash used in operating activities

 

 

(1,562,527

)

 

 

(3,400,005

)

Financing activities

 

 

 

 

 

 

Proceeds from February 2024 Offering

 

 

 

 

 

6,718,211

 

Payment of February 2024 Offering costs

 

 

 

 

 

(426,293

)

Proceeds from amendment and exercise of Series B Warrants, net of issuance costs

 

 

 

 

 

1,546,497

 

Proceeds from the issuance of common stock pursuant to the ESPP

 

 

24,999

 

 

 

 

Net cash provided by financing activities

 

 

24,999

 

 

 

7,838,415

 

Net (decrease) increase in cash and cash equivalents

 

 

(1,537,528

)

 

 

4,438,410

 

Cash and cash equivalents at beginning of period

 

 

13,596,600

 

 

 

4,739,426

 

Cash and cash equivalents at end of period

 

$

12,059,072

 

 

$

9,177,836

 

 

 

 

 

 

 

 

Supplemental disclosure of non-cash investing and financing activities

 

 

 

 

 

 

Warrant amendment costs included in accounts payable and accrued expenses

 

$

 

 

$

8,190

 

 

 

 


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