0000950170-25-070371.txt : 20250513 0000950170-25-070371.hdr.sgml : 20250513 20250513161509 ACCESSION NUMBER: 0000950170-25-070371 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 13 CONFORMED PERIOD OF REPORT: 20250513 ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20250513 DATE AS OF CHANGE: 20250513 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: 25940296 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-20250513.htm 8-K 8-K
0001403708false00014037082025-05-132025-05-13

 

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): May 13, 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 May 13, 2025, Evoke Pharma, Inc. issued a press release announcing its financial results for the first quarter ended March 31, 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 May 13, 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:

May 13, 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 First Quarter 2025 Financial Results and Provides Business Update

Q1 2025 Net Product Sales Increased 77% Year-over-Year to $3.1 Million

 

Sustained Momentum Driven by Growing Prescriber Adoption and Repeat Patient Use

SOLANA BEACH, Calif., May 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®, today announced financial results for the first quarter ended March 31, 2025, and provided a business update.

“We’re pleased to report continued strong revenue growth in the first quarter of 2025,” said Matt D’Onofrio, Chief Executive Officer of Evoke Pharma, Inc. “Net product sales rose 77% year-over-year, underscoring the strength of our commercial execution and GIMOTI’s growing adoption. We believe the underlying demand drivers remain strong—we achieved a 73% increase in fill rate and a 44% increase in our total prescriber base compared to Q1 last year. These improvements reflect continued depth of engagement and expanding interest among healthcare providers.”

 

First Quarter 2025 Highlights and Recent Developments

 

Corporate Governance

•
Appointed Greg Pyszczymuka to the Board of Directors. His extensive experience in commercial strategy and revenue growth will be valuable as the company advances its market position.

 

Commercial Execution

•
GIMOTI demonstrated solid momentum in Q1 with strong repeat usage, increasing prescription depth, and stable conversion rates.
•
Realized a 73% year-over-year increase in fill rate, driven by expanded pharmacy partnerships and reduced fulfillment friction.
•
Grew the total prescriber base by 44%, with increased provider confidence in GIMOTI’s efficacy and convenience.
•
Maintained strategic emphasis on GLP-1 patient populations, where the need for effective non-oral options continues to grow.

First Quarter 2025 Financial Results

For the first quarter of 2025, net product sales were approximately $3.1 million compared with $1.7 million during the first quarter of 2024, and net loss was approximately $1.3 million ($0.51 per share) compared with $1.6 million, ($2.09 per share) for the first quarter of 2024.

 

 


 

 

For the first quarter of 2025, selling, general, and administrative expenses were approximately $4.3 million compared to $3.1 million for the first quarter of 2024. The increase was due to higher professional fees and reimbursement and profit-sharing activity with EVERSANA as a result of an increase in net product sales.

Total operating expenses for the first quarter of 2025 were approximately $4.4 million compared to $3.2 million for the same period in 2024.

As of March 31, 2025, cash and cash equivalents were approximately $12.6 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 second quarter of 2026.

 

2025 Outlook

Evoke reiterates its 2025 net product sales guidance of approximately $16 million, reflecting a 60% increase over 2024. Evoke’s 2025 guidance is dependent on its current business and expectations, including recent growth rates in net product sales, assumptions regarding reimbursements and prescription fills, as well as factors that are outside of our control, such as the global macroeconomic and geopolitical environment, continued supply chain constraints and inflationary pressures.

“We’ve entered 2025 with strong momentum and a clear path forward,” added Mr. D’Onofrio. “With focused execution, expanded provider engagement, and the ongoing relevance of GIMOTI in a growing diabetic patient population, we’re confident in our ability to continue delivering growth and impact for patients who need better treatment options.”

About Evoke Pharma, Inc.

Evoke is a specialty pharmaceutical company focused primarily on the development of drugs to treat GI disorders and diseases. We 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; potential future provider engagement; the ongoing relevance of GIMOTI in a growing diabetic population; Evoke’s commercialization plans, including underlying drivers of potential growth and seasonality in sales; 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

 

 

 

 

 

 

March 31,

 

 

December 31,

 

 

 

2025

 

 

2024

 

 

 

(Unaudited)

 

 

 

 

Assets

 

 

 

 

 

 

Current assets:

 

 

 

 

 

 

Cash and cash equivalents

 

$

12,624,090

 

 

$

13,596,600

 

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

 

 

2,511,490

 

 

 

2,420,373

 

Prepaid expenses

 

 

523,910

 

 

 

731,945

 

Inventories

 

 

532,145

 

 

 

445,081

 

Other current assets

 

 

39,240

 

 

 

43,898

 

Total current assets

 

 

16,230,875

 

 

 

17,237,897

 

Operating lease right-of-use asset

 

 

138,758

 

 

 

154,184

 

Deferred offering costs

 

 

—

 

 

 

120,614

 

Other long-term assets

 

 

6,312

 

 

 

6,312

 

Total assets

 

$

16,375,945

 

 

$

17,519,007

 

Liabilities and stockholdersʼ equity

 

 

 

 

 

 

Current liabilities:

 

 

 

 

 

 

Accounts payable and accrued expenses

 

$

2,781,203

 

 

$

2,341,191

 

Accrued compensation

 

 

371,732

 

 

 

865,650

 

Operating lease liability

 

 

61,625

 

 

 

59,533

 

Note payable

 

 

5,000,000

 

 

 

5,000,000

 

Accrued interest payable

 

 

2,236,953

 

 

 

2,113,665

 

Total current liabilities

 

 

10,451,513

 

 

 

10,380,039

 

Operating lease liability, net of current portion

 

 

83,217

 

 

 

100,958

 

Total liabilities

 

 

10,534,730

 

 

 

10,480,997

 

Commitments and contingencies

 

 

 

 

 

 

Stockholdersʼ equity:

 

 

 

 

 

 

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

 

 

—

 

 

 

—

 

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

 

 

149

 

 

 

149

 

Additional paid-in capital

 

 

135,938,876

 

 

 

135,829,493

 

Accumulated deficit

 

 

(130,097,810

)

 

 

(128,791,632

)

Total stockholdersʼ equity

 

 

5,841,215

 

 

 

7,038,010

 

Total liabilities and stockholdersʼ equity

 

$

16,375,945

 

 

$

17,519,007

 

 

 

 

 

 


 

 

Evoke Pharma, Inc.

Statements of Operations

 

 

 

Three Months Ended March 31,

 

 

 

2025

 

 

2024

 

Net product sales

 

$

3,080,158

 

 

$

1,735,490

 

Operating expenses:

 

 

 

 

 

 

Cost of goods sold

 

 

41,613

 

 

 

92,529

 

Research and development

 

 

42,783

 

 

 

4,645

 

Selling, general and administrative

 

 

4,297,505

 

 

 

3,139,536

 

Total operating expenses

 

 

4,381,901

 

 

 

3,236,710

 

Loss from operations

 

 

(1,301,743

)

 

 

(1,501,220

)

Other income (expense):

 

 

 

 

 

 

Interest income

 

 

118,853

 

 

 

46,058

 

Interest expense

 

 

(123,288

)

 

 

(124,658

)

Total other expense

 

 

(4,435

)

 

 

(78,600

)

Net loss

 

$

(1,306,178

)

 

$

(1,579,820

)

Net loss per share of common stock, basic and diluted

 

$

(0.51

)

 

$

(2.09

)

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

 

 

2,548,684

 

 

 

756,808

 

 

 

 

 

 


 

 

Evoke Pharma, Inc.

Statements of Cash Flows

 

 

 

Three Months Ended March 31,

 

 

 

2025

 

 

2024

 

Operating activities

 

 

 

 

 

 

Net loss

 

$

(1,306,178

)

 

$

(1,579,820

)

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

 

 

 

 

 

 

Stock-based compensation expense

 

 

84,384

 

 

 

254,029

 

Non-cash interest expense

 

 

123,288

 

 

 

124,658

 

Non-cash operating lease expense

 

 

19,147

 

 

 

—

 

Change in operating assets and liabilities:

 

 

 

 

 

 

Accounts receivable

 

 

(91,117

)

 

 

(778,833

)

Prepaid expenses and other assets

 

 

333,307

 

 

 

222,045

 

Inventories

 

 

(87,064

)

 

 

(106,936

)

Accounts payable and accrued expenses

 

 

440,012

 

 

 

343,596

 

Accrued compensation

 

 

(493,918

)

 

 

(1,058,129

)

Operating lease liabilities

 

 

(19,370

)

 

 

—

 

Net cash used in operating activities

 

 

(997,509

)

 

 

(2,579,390

)

Financing activities

 

 

 

 

 

 

Proceeds from February 2024 Offering

 

 

—

 

 

 

6,718,211

 

Payment of February 2024 Offering costs

 

 

—

 

 

 

(426,292

)

Proceeds from March 2024 Warrant Amendment

 

 

—

 

 

 

1,250,800

 

Proceeds from the issuance of common stock pursuant to the ESPP

 

 

24,999

 

 

 

—

 

Net cash provided by financing activities

 

 

24,999

 

 

 

7,542,719

 

Net (decrease) increase in cash and cash equivalents

 

 

(972,510

)

 

 

4,963,329

 

Cash and cash equivalents at beginning of period

 

 

13,596,600

 

 

 

4,739,426

 

Cash and cash equivalents at end of period

 

$

12,624,090

 

 

$

9,702,755

 

 

 

 

 

 

 

 

Supplemental disclosure of non-cash investing and financing activities

 

 

 

 

 

 

Offering costs in accounts payable and accrued expenses

 

$

—

 

 

$

20,926

 

 

 

 


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Document And Entity Information
May 13, 2025
Cover [Abstract]  
Document Type 8-K
Amendment Flag false
Document Period End Date May 13, 2025
Entity Registrant Name EVOKE PHARMA, INC.
Entity Central Index Key 0001403708
Entity Emerging Growth Company false
Entity File Number 001-36075
Entity Incorporation, State or Country Code DE
Entity Tax Identification Number 20-8447886
Entity Address, Address Line One 420 Stevens Avenue, Suite 230
Entity Address, City or Town Solana Beach
Entity Address, State or Province CA
Entity Address, Postal Zip Code 92075
City Area Code 858
Local Phone Number 345-1494
Written Communications false
Soliciting Material false
Pre-commencement Tender Offer false
Pre-commencement Issuer Tender Offer false
Title of 12(b) Security Common Stock, par value $0.0001 per share
Trading Symbol EVOK
Security Exchange Name NASDAQ
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