
PART I. FINANCIAL INFORMATION This section presents Evoke Pharma, Inc.'s unaudited condensed financial statements and management's discussion and analysis of financial condition and results of operations Item 1. Financial Statements This section presents Evoke Pharma, Inc.'s unaudited condensed financial statements, including the Balance Sheets, Statements of Operations, Stockholders' Equity, and Cash Flows, along with detailed notes explaining the company's organization, significant accounting policies, commitments, equity transactions, commercial agreements, and segment information for the periods ended June 30, 2025, and December 31, 2024 Condensed Balance Sheets This section presents the company's unaudited condensed balance sheets as of June 30, 2025, and December 31, 2024 | Metric | June 30, 2025 | December 31, 2024 | | :-------------------------------- | :------------ | :---------------- | | Cash and cash equivalents | $12,059,072 | $13,596,600 | | Total current assets | $15,931,078 | $17,237,897 | | Total assets | $16,060,328 | $17,519,007 | | Total current liabilities | $11,620,808 | $10,380,039 | | Total liabilities | $11,685,836 | $10,480,997 | | Total stockholders' equity | $4,374,492 | $7,038,010 | Condensed Statements of Operations This section details the company's unaudited condensed statements of operations for the three and six months ended June 30, 2025 and 2024 | Metric | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--------------------------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Net product sales | $3,752,142 | $2,551,366 | $6,832,300 | $4,286,856 | | Cost of goods sold | $167,679 | $41,478 | $209,292 | $134,007 | | Research and development | $8,413 | $0 | $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) | | Net loss | $(1,570,976) | $(1,267,218) | $(2,877,154) | $(2,847,038) | | Net loss per share (basic & diluted)| $(0.62) | $(0.93) | $(1.13) | $(2.69) | Condensed Statements of Stockholders' Equity This section outlines changes in stockholders' equity for the three and six months ended June 30, 2025 and 2024 | Metric | Balance as of January 1, 2025 | Balance as of June 30, 2025 | | :-------------------------------- | :---------------------------- | :-------------------------- | | Common Stock Shares | 1,486,009 | 1,492,858 | | Common Stock Amount | $149 | $149 | | Additional Paid-In Capital | $135,829,493 | $136,043,129 | | Accumulated Deficit | $(128,791,632) | $(131,668,786) | | Total Stockholders' Equity | $7,038,010 | $4,374,492 | - Stock-based compensation expense for the six months ended June 30, 2025, was $188,637, and $380,607 for the same period in 202414 - Issuance of common stock pursuant to the ESPP resulted in $24,999 in additional paid-in capital for the six months ended June 30, 202514 Condensed Statements of Cash Flows This section presents the company's unaudited condensed statements of cash flows for the six months ended June 30, 2025 and 2024 | Cash Flow Activity | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--------------------------------- | :----------------------------- | :----------------------------- | | Net cash used in operating activities | $(1,562,527) | $(3,400,005) | | 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 end of period | $12,059,072 | $9,177,836 | Notes to Condensed Financial Statements This section provides explanatory notes to the unaudited condensed financial statements, detailing accounting policies and other relevant information 1. Organization and Basis of Presentation This note describes the company's business, its going concern status, and the basis for financial statement presentation - Evoke Pharma, Inc. is a specialty pharmaceutical company focused on developing and commercializing drugs for gastroenterological disorders, with its sole product being Gimoti® (metoclopramide) nasal spray for diabetic gastroparesis1920 - The company has incurred recurring losses and negative cash flows, leading management to conclude there is substantial doubt about its ability to continue as a going concern for one year after the financial statements' issuance date, with approximately $12.1 million in cash and cash equivalents as of June 30, 202522 - A 1-for-12 reverse stock split was effected on August 1, 2024, to regain compliance with Nasdaq's minimum bid price requirement2526 2. Summary of Significant Accounting Policies This note outlines the key accounting principles and policies applied in preparing the financial statements - The financial statements are prepared in accordance with GAAP for interim financial information, and management makes estimates and assumptions affecting reported amounts2728 - Revenue from Gimoti sales is recognized net of variable consideration (rebates, discounts, co-pay assistance) when the customer obtains control of the product383940 - The company evaluates the impact of recently issued accounting standards, including ASU 2023-09 (Income Tax Disclosures) and ASU 2024-03 (Expense Disaggregation Disclosures), but does not expect a material impact from the One Big Beautiful Bill Act (OBBBA) on its statement of operations454648 Inventories as of June 30, 2025 and December 31, 2024: | Category | June 30, 2025 | December 31, 2024 | | :------------- | :------------ | :---------------- | | Raw materials | $294,601 | $257,467 | | Finished goods | $347,271 | $187,614 | | Total inventories | $641,872 | $445,081 | 3. Commitments and Contingencies This note details the company's lease obligations and other potential liabilities - The company entered into a Current Lease for office space in Solana Beach, California, commencing November 1, 2024, and expiring March 31, 2027, with a remaining lease term of 1.8 years as of June 30, 202551 Lease Costs and Cash Paid for Leases: | Metric | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :---------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Lease costs | $19,147 | $18,966 | $39,254 | $37,902 | | Cash paid for leases | $19,371 | $18,966 | $38,742 | $37,902 | Future Lease Payments as of June 30, 2025: | Years Ending December 31, | Amount | | :------------------------ | :----- | | 2025 (Remainder) | $39,128 | | 2026 | $80,207 | | 2027 | $20,551 | | Total future lease payments | $139,886 | | Less: imputed interest | $(11,089) | | Total lease liability | $128,797 | 4. Stockholders' Equity This note provides information on equity transactions, including stock offerings, warrants, and stock-based compensation - In February 2024, the company completed an offering of common stock units and pre-funded warrant units, generating $6.2 million in net cash proceeds5455 - The company filed a universal shelf registration statement in August 2024 for up to $50.0 million in securities, but no shares have been issued under it as of June 30, 20255657 - Warrant amendments in March, June, and September 2024 encouraged the exercise of Series B Warrants and Series C Warrants, generating net cash proceeds of $1.2 million, $0.3 million, and $0.4 million, respectively6062 Warrants Outstanding as of June 30, 2025: | Warrant Type | Number of Warrants Outstanding | Exercise Price | Initial Exercise Date | Expiration Date | | :-------------------------- | :----------------------------- | :------------- | :-------------------- | :-------------------- | | Pre-Funded Warrants | 528,609 | $0.0012 | February 13, 2024 | Until Exercised in Full | | Series A Warrants | 354,022 | $8.16 | February 13, 2024 | February 13, 2029 | | Modified Series A Warrants | 281,080 | $0.01 | February 13, 2024 | February 13, 2029 | | Series C Warrants | 392,754 | $8.16 | February 13, 2024 | February 13, 2029 | | Modified Series C Warrants | 250,627 | $0.01 | February 13, 2024 | February 13, 2029 | | Representatives' Warrants | 45,955 | $13.47 | August 13, 2024 | February 13, 2029 | | Total warrants | 1,853,047 | | | | Stock-Based Compensation Expense: | Expense Category | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :-------------------------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Research and development | $0 | $0 | $4,373 | $1,215 | | Selling, general and administrative | $104,253 | $126,578 | $184,264 | $379,392 | | Total stock-based compensation expense | $104,253 | $126,578 | $188,637 | $380,607 | 5. Commercial Services and Loan Agreements with Eversana This note describes the commercial and loan agreements with Eversana for Gimoti's commercialization and distribution - The company has a commercial services agreement with Eversana for the commercialization and distribution of Gimoti in the U.S., with Eversana managing marketing, sales, and distribution, while the company retains ownership and regulatory responsibilities7374 - Eversana profit sharing costs included in selling, general and administrative expenses were approximately $3.2 million for the three months ended June 30, 2025 (vs. $2.2 million in 2024) and $5.8 million for the six months ended June 30, 2025 (vs. $3.6 million in 2024)74 - The Eversana Agreement can be terminated if net profit is negative for two consecutive quarters (NPQTR)77 - If Eversana exercises this right, the company would be responsible for repaying the $5.0 million loan principal and $2.4 million accrued interest (total $7.4 million as of June 30, 2025) within 90 days7879 6. Segment Information This note provides financial information for the company's single operating segment - The company operates within a single operating segment: the development and commercialization of pharmaceutical products, primarily in the United States8283 Segment Financial Data (Development and Commercialization of Pharmaceutical Products): | Metric | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :-------------------------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Net product sales | $3,752,142 | $2,551,366 | $6,832,300 | $4,286,856 | | Total segment costs loss and net loss | $(1,570,976) | $(1,267,218) | $(2,877,154) | $(2,847,038) | Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations This section provides management's perspective on Evoke Pharma's financial condition and results of operations, highlighting the commercialization of Gimoti, liquidity challenges, Nasdaq listing compliance, recent legislative impacts, and detailed analysis of revenue and expense trends for the three and six months ended June 30, 2025 and 2024 Overview This overview introduces Evoke Pharma, its primary product Gimoti, and its financial outlook - Evoke Pharma is a specialty pharmaceutical company focused on Gimoti (metoclopramide) nasal spray for diabetic gastroparesis, launched in October 2020 through its partner Eversana90 - A study showed Gimoti patients had significantly fewer physician office visits, emergency department visits, and inpatient hospitalizations, reducing patient and payor costs by approximately $15,000 over six months compared to oral metoclopramide91 - The company has incurred losses since inception and expects to continue doing so, with approximately $12.1 million in cash and cash equivalents as of June 30, 2025, which is believed to be sufficient to fund operations into Q3 2026, excluding potential early repayment of the Eversana Credit Facility9596 Nasdaq Listing and Reverse Stock Split This section details the company's efforts to maintain Nasdaq listing compliance, including a reverse stock split - Evoke Pharma regained compliance with Nasdaq's Minimum Stockholders' Equity Requirement on June 4, 2024, and was no longer under panel monitor as of June 20, 202597 - To address the Minimum Bid Price Requirement, a 1-for-12 reverse stock split was effected on August 1, 2024, leading to compliance by August 15, 202499100 Recent Developments This section discusses recent legislative changes and their potential impact on the company's operations - The One Big Beautiful Bill Act (OBBBA) was signed into law in July 2025, making permanent key elements of the Tax Cuts and Jobs Act of 2017 and accelerating tax deductions101 - The company is assessing its impact but currently believes it will not materially affect its statement of operations101 Financial Operations Overview This overview covers revenue recognition, sales trends, and expected changes in research and development and selling, general and administrative expenses - Revenue recognition follows ASC 606, with product revenues recorded net of sales-related adjustments like Medicaid/Medicare rebates and co-payment assistance103104105 - Net product sales increased by $0.7 million QoQ to $3.7 million for the quarter ended June 30, 2025, driven by an expanded pharmacy network, increased prescriber adoption, and higher patient refill rates106119 - New inbound prescriptions into the ASPN reimbursement center increased by 9.3% QoQ to approximately 1,960 during the quarter ended June 30, 2025107 - Research and development expenses have decreased since Gimoti's FDA approval, shifting to commercialization costs112 - Future R&D expenses are expected to increase significantly with the initiation of a post-marketing commitment single-dose PK clinical trial112 - Selling, general and administrative expenses are expected to increase as commercialization of Gimoti progresses and Eversana is reimbursed from net profits115 Critical Accounting Policies and Significant Judgments and Estimates This section confirms no material changes to critical accounting policies and estimates - There have been no new or significant changes to the critical accounting policies and estimates discussed in the Annual Report on Form 10-K for the year ended December 31, 2024118 Results of Operations This section provides a detailed comparison of financial performance for the three and six months ended June 30, 2025 and 2024 - The increase in net product sales for both periods is attributed to an expanded pharmacy network, increased physician prescribing, and higher patient refill rates119124 - Selling, general and administrative expenses increased primarily due to higher marketing and Eversana profit sharing amounts, professional fees, and product liability insurance costs, partially offset by a decrease in stock-based compensation for the six-month period122127 Comparison of Three Months Ended June 30, 2025 and 2024: | Metric | 2025 | 2024 | $ Change | % Change | | :-------------------------------- | :----------- | :----------- | :--------- | :--------- | | Net product sales | $3,752,142 | $2,551,366 | $1,200,776 | 47% | | Cost of goods sold | $167,679 | $41,478 | $126,201 | 304% | | Research and development expenses | $8,413 | $0 | $8,413 | 100% | | Selling, general and administrative expenses | $5,134,902 | $3,733,450 | $1,401,452 | 38% | Comparison of Six Months Ended June 30, 2025 and 2024: | Metric | 2025 | 2024 | $ Change | % Change | | :-------------------------------- | :----------- | :----------- | :--------- | :--------- | | Net product sales | $6,832,300 | $4,286,856 | $2,545,444 | 59% | | Cost of goods sold | $209,292 | $134,007 | $75,285 | 56% | | Research and development expenses | $51,196 | $4,645 | $46,551 | 1002% | | Selling, general and administrative expenses | $9,432,407 | $6,872,986 | $2,559,421 | 37% | Liquidity and Capital Resources This section discusses the company's cash position, funding sources, and future capital requirements - The company's operations have been primarily funded by equity sales and borrowings, including a $5.0 million revolving credit facility from Eversana128129 - As of June 30, 2025, cash and cash equivalents were approximately $12.1 million130 - Management believes there is substantial doubt about the company's ability to continue as a going concern for one year due to anticipated losses and potential early repayment of the Eversana Credit Facility ($7.4 million principal and accrued interest)130 - Cash provided by financing activities significantly decreased from $7.8 million in H1 2024 (due to common stock and warrant sales) to $24,999 in H1 2025 (due to ESPP issuance)133 - Future funding requirements depend on commercialization costs, Gimoti's success, manufacturing capabilities, costs of post-marketing clinical trials, intellectual property maintenance, and potential collaboration arrangements135 Summary of Cash Flows: | Cash Flow Activity | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | $ Change | | :--------------------------------- | :----------------------------- | :----------------------------- | :--------- | | Net cash used in operating activities | $(1,562,527) | $(3,400,005) | $1,837,478 | | Net cash provided by financing activities | $24,999 | $7,838,415 | $(7,813,416) | | Net (decrease) increase in cash and cash equivalents | $(1,537,528) | $4,438,410 | $(5,975,938) | Item 3. Quantitative and Qualitative Disclosures about Market Risk As a smaller reporting company, Evoke Pharma, Inc. is not required to provide quantitative and qualitative disclosures about market risk - As a smaller reporting company, Evoke Pharma, Inc. is exempt from providing quantitative and qualitative disclosures about market risk136 Item 4. Controls and Procedures This section confirms the effectiveness of Evoke Pharma's disclosure controls and procedures as of June 30, 2025, and reports no material changes in internal control over financial reporting during the quarter - The Chief Executive Officer and Chief Financial Officer concluded that the company's disclosure controls and procedures were effective at the reasonable assurance level as of June 30, 2025138 - There were no changes in internal control over financial reporting during the quarter ended June 30, 2025, that materially affected, or are reasonably likely to materially affect, internal control over financial reporting139 PART II. OTHER INFORMATION This section covers legal proceedings, risk factors, equity sales, defaults, mine safety, other information, and exhibits Item 1. Legal Proceedings Evoke Pharma, Inc. reports no legal proceedings for the period - There are no legal proceedings to report140 Item 1A. Risk Factors This section outlines material changes to risk factors, primarily focusing on the increasing difficulty and cost of commercializing Gimoti due to enacted and proposed healthcare legislation, including the Inflation Reduction Act of 2022 and the One Big Beautiful Bill Act - No material changes to risk factors were reported other than those related to enacted and future legislation affecting the commercialization and pricing of pharmaceutical products141 - The Inflation Reduction Act of 2022 (IRA) requires Medicare drug price negotiations, imposes rebates for price increases exceeding inflation, and modifies the Part D coverage gap discount program, likely having a significant impact on the pharmaceutical industry147148 - The One Big Beautiful Bill Act (OBBBA), enacted in July 2025, imposes significant reductions in Medicaid program funding, which could decrease enrollment and covered services, adversely affecting Gimoti sales149 - Individual states are increasingly implementing legislation and regulations to control pharmaceutical product pricing, including price caps and transparency measures, which could reduce demand or pressure pricing for the company's products151 Item 2. Unregistered Sales of Equity Securities and Use of Proceeds Evoke Pharma, Inc. reports no unregistered sales of equity securities or use of proceeds for the period - There were no unregistered sales of equity securities or use of proceeds to report153 Item 3. Defaults Upon Senior Securities Evoke Pharma, Inc. reports no defaults upon senior securities for the period - There were no defaults upon senior securities to report153 Item 4. Mine Safety Disclosures Evoke Pharma, Inc. states that mine safety disclosures are not applicable to its operations - Mine safety disclosures are not applicable to the company153 Item 5. Other Information Evoke Pharma, Inc. confirms that no officers or directors adopted, modified, or terminated Rule 10b5-1 trading plans during the quarter ended June 30, 2025 - No officers or directors adopted, modified, or terminated any Rule 10b5-1 trading arrangements during the three months ended June 30, 2025154 Item 6. Exhibits This section lists all exhibits filed with the Form 10-Q, including certificates of incorporation, warrant forms, certifications of principal officers, and XBRL instance documents - The exhibits include various corporate documents such as Amended and Restated Certificate of Incorporation, forms of warrants (Pre-Funded, Series A, B, C, Representative's), warrant amendments, and certifications by the Principal Executive and Financial Officers158 SIGNATURES This section contains the official signatures of the company's principal executive and financial officers - The report is signed by Matthew J. D'Onofrio, Chief Executive Officer, and Mark Kowieski, Chief Financial Officer, on August 14, 2025164165