UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Commission File Number 001-36075 EVOKE PHARMA, INC. (Exact name of registrant as specified in its charter) Delaware 20-8447886 (State or other jurisdiction of incorporation) (IRS Employer I ...

SOLANA BEACH, Calif., April 17, 2024 (GLOBE NEWSWIRE) -- Evoke Pharma, Inc. (NASDAQ:EVOK), a specialty pharmaceutical company focused primarily on treatments for gastrointestinal (GI) diseases with an emphasis on GIMOTI® (metoclopramide) nasal spray, announced it will host a virtual KOL and investor webinar on Wednesday, April 24 at 12:00 p.m. ET. Moderated by Yale Jen, PhD, Senior Managing Director of Equity Research at Laidlaw Capital Markets, the event will feature Michael Cline, DO., Medical Director Ga ...

SOLANA BEACH, Calif., March 21, 2024 (GLOBE NEWSWIRE) -- Evoke Pharma, Inc. (NASDAQ:EVOK), a specialty pharmaceutical company focused primarily on treatments for gastrointestinal (GI) diseases with an emphasis on GIMOTI® (metoclopramide) nasal spray, announced that Matthew J. D'Onofrio will be succeeding David A. Gonyer as Chief Executive Officer as of March 31, 2024 upon Mr. Gonyer's departure for personal reasons. Mr. D'Onofrio currently serves as President and Chief Operating Officer. "Working closely wi ...

For the transition period from to Commission file number: 001-36075 Evoke Pharma, Inc. (Exact Name of Registrant as Specified in its Charter) UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 Form 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2023 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Delaware 20-8447886 (State or Other Jurisdiction of In ...

SOLANA BEACH, Calif., March 07, 2024 (GLOBE NEWSWIRE) -- Evoke Pharma, Inc. (NASDAQ:EVOK), a specialty pharmaceutical company focused on treatments for gastrointestinal (GI) diseases with an emphasis on Gimoti® (metoclopramide) nasal spray, today announced that the Company is scheduled to release its fourth quarter and full year 2023 on Thursday, March 14, 2024, after the market closes. Management will host a conference call and webcast with accompanying slides on Thursday, March 14, 2024, at 4:30 p.m. ET t ...

SOLANA BEACH, Calif., March 07, 2024 (GLOBE NEWSWIRE) -- Evoke Pharma, Inc. (NASDAQ: EVOK), a specialty pharmaceutical company focused on treatments for gastrointestinal (GI) diseases with an emphasis on Gimoti® (metoclopramide) nasal spray, today announced that the Company is scheduled to release its fourth quarter and full year 2023 on Thursday, March 14, 2024, after the market closes. Management will host a conference call and webcast with accompanying slides on Thursday, March 14, 2024, at 4:30 p.m. ET ...

SOLANA BEACH, Calif., Feb. 14, 2024 (GLOBE NEWSWIRE) -- Evoke Pharma, Inc. (NASDAQ:EVOK), a specialty pharmaceutical company focused primarily on treatments for gastrointestinal (GI) diseases with an emphasis on GIMOTI® (metoclopramide) nasal spray, announced today that it has closed an underwritten public offering led by Nantahala Capital Management, with participation by other fundamental investors, for gross proceeds of up to $30 million, which included an initial upfront funding of approximately $7.5 mi ...

SOLANA BEACH, Calif., Feb. 09, 2024 (GLOBE NEWSWIRE) -- Evoke Pharma, Inc. (NASDAQ:EVOK), a specialty pharmaceutical company focused primarily on treatments for gastrointestinal (GI) diseases with an emphasis on GIMOTI® (metoclopramide) nasal spray, announced today that it has priced an underwritten public offering led by Nantahala Capital Management, with participation by other fundamental investors, for gross proceeds of up to $30 million, that includes initial upfront funding of approximately $7.5 millio ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Commission File Number 001-36075 EVOKE PHARMA, INC. (Exact name of registrant as specified in its charter) (State or other jurisdiction of incorporation) Delaware 20-8447886 (IRS Employ ...

[PART I. FINANCIAL INFORMATION](index=3&type=section&id=PART%20I.%20FINANCIAL%20INFORMATION) [Item 1. Financial Statements](index=3&type=section&id=Item%201.%20Financial%20Statements) The financial statements reveal increased net product sales but continued net losses, with cash and equity significantly declining, raising going concern and Nasdaq compliance issues [Condensed Balance Sheets](index=3&type=section&id=Condensed%20Balance%20Sheets) As of June 30, 2023, total assets decreased to $9.0 million, primarily due to reduced cash, while liabilities increased and stockholders' equity significantly declined to $0.5 million Condensed Balance Sheet Highlights (in thousands) | Account | June 30, 2023 (Unaudited) | December 31, 2022 | | :--- | :--- | :--- | | Cash and cash equivalents | $7,006 | $9,844 | | Total current assets | $8,927 | $11,722 | | Total assets | $8,980 | $11,851 | | Total current liabilities | $2,081 | $1,655 | | Total liabilities | $8,441 | $7,767 | | Total stockholders' equity | $538 | $4,085 | [Condensed Statements of Operations](index=4&type=section&id=Condensed%20Statements%20of%20Operations) Net product sales grew significantly in Q2 and H1 2023, with the net loss narrowing slightly for both periods compared to the prior year Condensed Statements of Operations Highlights (in thousands) | Metric | Q2 2023 | Q2 2022 | H1 2023 | H1 2022 | | :--- | :--- | :--- | :--- | :--- | | Net product sales | $1,131 | $462 | $1,942 | $880 | | Loss from operations | $(1,784) | $(2,113) | $(3,940) | $(4,164) | | Net loss | $(1,868) | $(2,233) | $(4,111) | $(4,407) | | Net loss per share | $(0.56) | $(0.71) | $(1.23) | $(1.50) | [Condensed Statements of Cash Flows](index=6&type=section&id=Condensed%20Statements%20of%20Cash%20Flows) Net cash used in operations slightly improved in H1 2023, with no financing activities, leading to a net decrease in cash and an ending balance of $7.0 million Six Months Ended June 30 Cash Flow Summary (in thousands) | Cash Flow Item | 2023 | 2022 | | :--- | :--- | :--- | | Net cash used in operating activities | $(2,837) | $(2,989) | | Net cash provided by financing activities | $0 | $7,295 | | Net (decrease) increase in cash | $(2,837) | $4,306 | | Cash at end of period | $7,006 | $13,451 | [Notes to Condensed Financial Statements](index=7&type=section&id=Notes%20to%20Condensed%20Financial%20Statements) Notes highlight substantial doubt about going concern, Nasdaq non-compliance, and significant commercialization costs and loan obligations with Eversana - The company believes there is substantial doubt about its ability to continue as a going concern for one year, citing recurring losses, negative cash flows, and the need to raise additional funds[20](index=20&type=chunk) - On May 24, 2023, the company received a notice from Nasdaq for non-compliance with the minimum stockholders' equity requirement of **$2.5 million**. Nasdaq granted an extension until November 20, 2023, to regain compliance[24](index=24&type=chunk)[25](index=25&type=chunk)[26](index=26&type=chunk) - The company has a commercial services agreement with Eversana to commercialize Gimoti. As of June 30, 2023, unreimbursed commercialization costs to Eversana were approximately **$57.2 million**[61](index=61&type=chunk)[62](index=62&type=chunk) - The company has a **$5 million** revolving credit facility with Eversana, which was fully drawn in 2020. The facility is secured by all personal property other than intellectual property[69](index=69&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=15&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses Gimoti's sales growth, ongoing operating losses, critical liquidity issues, and the substantial doubt about going concern, alongside Nasdaq delisting risks [Overview](index=15&type=section&id=Overview) Evoke Pharma, a specialty pharmaceutical company, focuses on its sole product, Gimoti, for diabetic gastroparesis, commercialized through Eversana, despite ongoing losses - The company's sole product is Gimoti® (metoclopramide) nasal spray, the first nasally-administered product for relief of symptoms in adults with acute and recurrent diabetic gastroparesis[18](index=18&type=chunk)[76](index=76&type=chunk) - Commercial sales of Gimoti in the U.S. are managed by its partner, Eversana Life Science Services, LLC, under an agreement extending to December 31, 2026[76](index=76&type=chunk)[78](index=78&type=chunk) [Results of Operations](index=19&type=section&id=Results%20of%20Operations) Q2 2023 saw increased net product sales and SG&A expenses due to marketing, while R&D decreased, reflecting similar trends for the six-month period Comparison of Three Months Ended June 30, 2023 and 2022 (in thousands) | Metric | 2023 | 2022 | Change | | :--- | :--- | :--- | :--- | | Net product sales | $1,131 | $462 | $670 | | Research and development expenses | $92 | $191 | $(99) | | Selling, general and administrative expenses | $2,766 | $2,315 | $451 | Comparison of Six Months Ended June 30, 2023 and 2022 (in thousands) | Metric | 2023 | 2022 | Change | | :--- | :--- | :--- | :--- | | Net product sales | $1,942 | $880 | $1,062 | | Research and development expenses | $159 | $233 | $(74) | | Selling, general and administrative expenses | $5,614 | $4,720 | $894 | - The increase in SG&A expenses in Q2 2023 was primarily due to higher costs for marketing and Eversana profit sharing, which amounted to approximately **$1.1 million**[104](index=104&type=chunk) [Liquidity and Capital Resources](index=21&type=section&id=Liquidity%20and%20Capital%20Resources) With $7.0 million cash, the company faces substantial doubt about going concern, requiring additional capital, and is working to regain Nasdaq compliance by November 2023 - Management concluded there is substantial doubt about the company's ability to continue as a going concern[116](index=116&type=chunk) - Cash and cash equivalents of approximately **$7.0 million** as of June 30, 2023, are expected to be sufficient to fund operations only into the first quarter of 2024[82](index=82&type=chunk)[116](index=116&type=chunk) - The company received a notice from Nasdaq for non-compliance with the minimum stockholders' equity requirement and has until November 20, 2023, to regain compliance[121](index=121&type=chunk) - The company's ability to sell shares under its Form S-3 shelf registration is limited by the SEC's 'baby shelf rules' because its public float is less than **$75 million**[111](index=111&type=chunk)[112](index=112&type=chunk) [Item 3. Quantitative and Qualitative Disclosures about Market Risk](index=23&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20about%20Market%20Risk) As a smaller reporting company, Evoke Pharma is exempt from providing quantitative and qualitative disclosures about market risk - The company is not required to provide information on market risk as it qualifies as a smaller reporting company[126](index=126&type=chunk) [Item 4. Controls and Procedures](index=23&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that disclosure controls and procedures were effective as of June 30, 2023, with no material changes to internal control over financial reporting - Management, including the CEO and Chief Business Officer, concluded that the company's disclosure controls and procedures were effective as of June 30, 2023[128](index=128&type=chunk)[129](index=129&type=chunk) - No material changes to the company's internal control over financial reporting were identified during the quarter ended June 30, 2023[130](index=130&type=chunk) [PART II. OTHER INFORMATION](index=24&type=section&id=PART%20II.%20OTHER%20INFORMATION) [Item 1. Legal Proceedings](index=24&type=section&id=Item%201.%20Legal%20Proceedings) The company successfully dismissed patent litigation against Teva Pharmaceuticals, preventing FDA approval of Teva's generic Gimoti until Evoke's patent expires in 2030 - In response to Teva's ANDA filing for a generic version of Gimoti, the company initiated patent infringement litigation in April 2022[51](index=51&type=chunk)[131](index=131&type=chunk) - The litigation against Teva was dismissed in January 2023 after Teva converted to a Paragraph III certification, which prevents FDA approval of its generic product until 2030[51](index=51&type=chunk)[131](index=131&type=chunk) [Item 1A. Risk Factors](index=24&type=section&id=Item%201A.%20Risk%20Factors) Key risks include the need for substantial additional funding to avoid liquidation and the potential delisting from Nasdaq due to non-compliance with equity requirements - The company requires substantial additional funding and may be forced to liquidate, dissolve, or wind down operations if it cannot raise capital[132](index=132&type=chunk) - The company is at risk of being delisted from the Nasdaq Capital Market for failing to meet the minimum stockholders' equity requirement. It has been granted an extension until November 20, 2023, to regain compliance[136](index=136&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=25&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) The company reported no unregistered sales of equity securities during the period - None[138](index=138&type=chunk) [Item 6. Exhibits](index=27&type=section&id=Item%206.%20Exhibits) This section lists the exhibits filed with the Form 10-Q, including corporate governance documents and officer certifications