LOS ANGELES--(BUSINESS WIRE)--Ranking recognizes Evoke's achievement in advancing client experience, and its leadership as a trusted advisor in the RIA industry. ...

Core Viewpoint - Evoke Pharma, Inc. is expanding access to its GIMOTI nasal spray for diabetic gastroparesis through strategic partnerships with Omnicell and Brentwood Pharmacy, aiming to enhance patient care and streamline access to treatment [1][2][3]. Company Overview - Evoke Pharma, Inc. is a specialty pharmaceutical company focused on developing treatments for gastrointestinal disorders, particularly GIMOTI, a nasal spray formulation of metoclopramide for adults with acute and recurrent diabetic gastroparesis [4][5]. Strategic Partnerships - The partnership with Omnicell is expected to nearly double the number of specialty pharmacies that can access GIMOTI, aligning with large gastroenterology practices like Gastro Health, which operates in 7 states and has 150 locations [2][3]. - The agreement with Brentwood Pharmacy, affiliated with OneGI, enhances access to GIMOTI across multiple states, including Tennessee, Kentucky, Ohio, and Mississippi, and supports rapid delivery and additional insurance plan access for patients [3][4]. Market Context - Diabetic gastroparesis is a significant gastrointestinal disorder affecting millions globally, characterized by delayed gastric emptying, which can complicate the absorption of orally administered medications [5]. - GIMOTI is the only FDA-approved treatment for diabetic gastroparesis in the United States, previously available only in oral and injectable forms [5]. Industry Collaboration - EVERSANA, a provider of global commercial services to the life sciences industry, is supporting Evoke in its strategy to improve patient access and streamline the integration with specialty pharmacies [1][12]. - Gastro Health and OneGI are key players in the gastroenterology space, providing extensive networks of physicians and specialized care, which Evoke aims to leverage through its partnerships [13][14].

Company Overview - Evoke Pharma, Inc. is a specialty pharmaceutical company focused on developing treatments for gastrointestinal diseases, particularly GIMOTI (metoclopramide) nasal spray for diabetic gastroparesis [4] - GIMOTI is the only drug approved in the U.S. for treating gastroparesis, which affects millions globally and can lead to serious gastrointestinal symptoms and complications [5] Patent Announcement - Evoke Pharma announced the listing of U.S. Patent No. 12,377,064 for GIMOTI in the FDA's Orange Book, which covers its use in patients with moderate to severe gastroparesis symptoms [1][3] - The new patent is set to expire on November 17, 2038, extending the commercial life of GIMOTI by approximately eight years compared to the previous patent expiring on May 15, 2030 [3] Strategic Implications - The patent listing reflects Evoke's commitment to innovation and protecting its investments, aiming to maximize GIMOTI's market presence and ensure patient access to effective non-oral treatments [2][3] - The company emphasizes the importance of GIMOTI as a non-oral option for patients who struggle with oral medication absorption due to gastroparesis [3]

Executive Summary & Business Update [Second Quarter 2025 Highlights](index=1&type=section&id=Second%20Quarter%202025%20Highlights) Evoke Pharma reported strong Q2 2025 results, with GIMOTI net product sales increasing significantly year-over-year, driven by expanded pharmacy access and increased physician adoption Q2 2025 Net Product Sales | Metric | Q2 2025 ($M) | Q2 2024 ($M) | YoY Change (%) | | :---------------- | :-------- | :-------- | :--------- | | Net Product Sales | $3.8M | $2.6M | +47% | - New prescribers increased **20% year-over-year**[2](index=2&type=chunk) [CEO Commentary](index=1&type=section&id=CEO%20Commentary) The CEO highlighted GIMOTI's commercial strength and execution, noting accelerating demand from physicians and patients, improving fill rates, and broadening prescriber adoption, positioning GIMOTI as an essential treatment option for diabetic gastroparesis - CEO Matt D'Onofrio stated, "This quarter's results demonstrate the commercial strength of GIMOTI and the precision of our execution."[2](index=2&type=chunk) - Demand is accelerating from both physicians and patients, with improving fill rates and broadening prescriber adoption across GI practices[2](index=2&type=chunk) Financial Results Overview [Second Quarter 2025 Financial Performance](index=1&type=section&id=Second%20Quarter%202025%20Financial%20Performance) Evoke Pharma reported a net loss of **$1.6 million** for Q2 2025, an increase from **$1.3 million** in Q2 2024, despite a significant increase in net product sales Q2 2025 Key Financials | Metric | Q2 2025 (USD) | Q2 2024 (USD) | | :---------------- | :-------- | :-------- | | Net Product Sales | $3.8M | $2.6M | | Net Loss | $1.6M | $1.3M | | EPS | ($0.62) | ($0.93) | [Operating Expenses](index=1&type=section&id=Operating%20Expenses) Total operating expenses increased to **$5.3 million** in Q2 2025 from **$3.8 million** in Q2 2024, primarily due to higher selling, general, and administrative (SG&A) expenses driven by increased profit-sharing with EVERSANA and professional fees Q2 2025 Operating Expenses | Expense Category | Q2 2025 ($M) | Q2 2024 ($M) | | :----------------------- | :-------- | :-------- | | Selling, General, & Admin | $5.1M | $3.7M | | Total Operating Expenses | $5.3M | $3.8M | - Increase in SG&A was due to higher profit-sharing activity with EVERSANA and higher professional fees[5](index=5&type=chunk) [Cash Position and Runway](index=1&type=section&id=Cash%20Position%20and%20Runway) As of June 30, 2025, Evoke Pharma had **$12.1 million** in cash and cash equivalents, which is projected to fund operations into the third quarter of 2026 Cash and Cash Equivalents | Metric | As of June 30, 2025 (USD) | | :---------------------- | :------------------ | | Cash and Cash Equivalents | ~$12.1 million | - Existing cash and future cash flows from GIMOTI net product sales are believed to be sufficient to fund operations into the third quarter of 2026[6](index=6&type=chunk) 2025 Outlook and Business Developments [2025 Revenue Outlook](index=1&type=section&id=2025%20Revenue%20Outlook) Evoke Pharma confirmed its full-year 2025 net product sales guidance of approximately **$16 million**, representing up to a **60% increase** over 2024, based on current business outlook, prescription growth, refill rates, and expanded pharmacy access Full-Year 2025 Net Product Sales Guidance | Metric | Guidance | | :------------------------ | :------------- | | Full-Year 2025 Net Product Sales | ~$16 million | | Projected YoY Increase over 2024 | Up to 60% | - Guidance reflects current business outlook, including recent trends in prescription growth and refill rates, expanded pharmacy access, and continued adoption of GIMOTI[7](index=7&type=chunk)[8](index=8&type=chunk) [Key Business Developments](index=1&type=section&id=Key%20Business%20Developments) Recent business developments include a **20% year-over-year** growth in new prescribers, steady refill rates of approximately **70%**, and the presentation of real-world safety data for GIMOTI at Digestive Disease Week (DDW) 2025 - New prescribers grew **20% year-over-year**, continuing a positive trend of clinical adoption[7](index=7&type=chunk) - Refill rates held steady at approximately **70%**, reflecting consistent therapeutic benefit[7](index=7&type=chunk) - Presented real-world safety data at Digestive Disease Week (DDW) 2025, comparing incidence of tardive dyskinesia among continuous versus intermittent metoclopramide use[7](index=7&type=chunk) Company and Product Information [About Evoke Pharma, Inc.](index=2&type=section&id=About%20Evoke%20Pharma%2C%20Inc.) Evoke Pharma is a specialty pharmaceutical company focused on developing and commercializing drugs for gastrointestinal (GI) disorders, with GIMOTI, a nasal spray formulation of metoclopramide, being its primary product for diabetic gastroparesis - Evoke is a specialty pharmaceutical company focused primarily on the development of drugs to treat GI disorders and diseases[9](index=9&type=chunk) - 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[9](index=9&type=chunk) - Diabetic gastroparesis is a GI disorder affecting millions of patients worldwide, where the stomach takes too long to empty its contents[10](index=10&type=chunk) [About GIMOTI® (metoclopramide) nasal spray](index=2&type=section&id=About%20GIMOTI%C2%AE%20(metoclopramide)%20nasal%20spray) GIMOTI is indicated for the relief of symptoms in adults with acute and recurrent diabetic gastroparesis, but carries a WARNING for tardive dyskinesia (TD) and has several contraindications and potential adverse reactions [Indication and Important Safety Information](index=2&type=section&id=Indication%20and%20Important%20Safety%20Information) GIMOTI is indicated for symptom relief in adults with acute and recurrent diabetic gastroparesis, but comes with a significant warning regarding tardive dyskinesia - GIMOTI is indicated for the relief of symptoms in adults with acute and recurrent diabetic gastroparesis[11](index=11&type=chunk) - WARNING: TARDIVE DYSKINESIA (TD), a serious movement disorder that is often irreversible, is associated with metoclopramide use[11](index=11&type=chunk)[12](index=12&type=chunk) [Warnings and Contraindications](index=2&type=section&id=Warnings%20and%20Contraindications) GIMOTI is not recommended for use in pediatric patients, those with moderate to severe hepatic or renal impairment, or concurrent use of strong CYP2D6 inhibitors. It is contraindicated in patients with a history of TD, conditions where GI motility stimulation is dangerous, pheochromocytoma, epilepsy, or hypersensitivity to metoclopramide - GIMOTI is not recommended for use in pediatric patients, or patients with moderate/severe hepatic or renal impairment, or those concurrently using strong CYP2D6 inhibitors[12](index=12&type=chunk) - Contraindications include a history of tardive dyskinesia, gastrointestinal hemorrhage/obstruction/perforation, pheochromocytoma, epilepsy, or hypersensitivity to metoclopramide[12](index=12&type=chunk)[13](index=13&type=chunk) - Treatment with metoclopramide (all dosage forms) should be avoided for longer than **12 weeks** due to increased risk of developing TD[12](index=12&type=chunk) [Potential Adverse Reactions](index=3&type=section&id=Potential%20Adverse%20Reactions) Potential adverse reactions include tardive dyskinesia, other extrapyramidal effects, parkinsonism symptoms, neuroleptic malignant syndrome, depression, hypertension, and hyperprolactinemia. The most common adverse reactions (≥5%) are dysgeusia, headache, and fatigue - Potential adverse reactions include Tardive dyskinesia (TD), other extrapyramidal effects (EPS), parkinsonism symptoms, motor restlessness, neuroleptic malignant syndrome (NMS), depression, suicidal ideation and suicide, hypertension, fluid retention, and hyperprolactinemia[13](index=13&type=chunk) - Most common adverse reactions (**≥5%**) for GIMOTI are dysgeusia, headache, and fatigue[13](index=13&type=chunk) Financial Statements [Balance Sheets](index=4&type=section&id=Balance%20Sheets) As of June 30, 2025, total assets decreased to **$16.06 million** from **$17.52 million** at December 31, 2024, primarily due to a decrease in cash and cash equivalents. Total liabilities increased to **$11.69 million** from **$10.48 million**, while total stockholders' equity decreased Balance Sheet Data (in USD) | Metric | June 30, 2025 | December 31, 2024 | Change | | :-------------------------- | :-------------- | :---------------- | :----- | | Cash and cash equivalents | $12,059,072 | $13,596,600 | -$1,537,528 | | Total current assets | $15,931,078 | $17,237,897 | -$1,306,819 | | Total assets | $16,060,328 | $17,519,007 | -$1,458,679 | | Total current liabilities | $11,620,808 | $10,380,039 | +$1,240,769 | | Total liabilities | $11,685,836 | $10,480,997 | +$1,204,839 | | Total stockholders' equity | $4,374,492 | $7,038,010 | -$2,663,518 | [Statements of Operations](index=5&type=section&id=Statements%20of%20Operations) For the three months ended June 30, 2025, net product sales increased by **47% year-over-year**, but the net loss widened to **$1.57 million** from **$1.27 million** in the prior year, primarily due to increased operating expenses, particularly selling, general, and administrative costs Statements of Operations (Three Months Ended June 30, in USD) | Metric | 2025 | 2024 | YoY Change | | :-------------------------- | :----------- | :----------- | :--------- | | Net product sales | $3,752,142 | $2,551,366 | +47.06% | | Cost of goods sold | $167,679 | $41,478 | +304.26% | | Selling, general and administrative | $5,134,902 | $3,733,450 | +37.55% | | Total operating expenses | $5,310,994 | $3,774,928 | +40.67% | | Net loss | $(1,570,976) | $(1,267,218) | +24.00% | | Net loss per share (basic and diluted) | $(0.62) | $(0.93) | -33.33% | Statements of Operations (Six Months Ended June 30, in USD) | Metric | 2025 | 2024 | YoY Change | | :-------------------------- | :----------- | :----------- | :--------- | | Net product sales | $6,832,300 | $4,286,856 | +59.40% | | Net loss | $(2,877,154) | $(2,847,038) | +1.06% | | Net loss per share (basic and diluted) | $(1.13) | $(2.69) | -57.99% | [Statements of Cash Flows](index=6&type=section&id=Statements%20of%20Cash%20Flows) For the six months ended June 30, 2025, net cash used in operating activities decreased significantly to **$1.56 million** from **$3.40 million** in the prior year, primarily due to changes in operating assets and liabilities. Net cash provided by financing activities was minimal in 2025 compared to substantial proceeds in 2024 from offerings and warrant exercises Statements of Cash Flows (Six Months Ended June 30, in USD) | Metric | 2025 | 2024 | | :---------------------------------- | :----------- | :----------- | | Net cash used in operating activities | $(1,562,527) | $(3,400,005) | | Net cash provided by financing activities | $24,999 | $7,838,415 | | Cash and cash equivalents at end of period | $12,059,072 | $9,177,836 | Legal and Contact Information [Safe Harbor Statement](index=3&type=section&id=Safe%20Harbor%20Statement) This section serves as a cautionary statement regarding forward-looking statements in the press release, emphasizing that actual results may differ due to inherent risks and uncertainties in Evoke's business, including market demand for GIMOTI, financing needs, dependence on third parties, and intellectual property protection - Forward-looking statements include guidance regarding **2025 net product sales**, demand for GIMOTI, its ongoing relevance, and Evoke's expected cash runway[16](index=16&type=chunk) - Actual results may differ due to risks such as decreased demand for GIMOTI, ability to drive market demand, need for additional financing, potential termination of EVERSANA agreement, dependence on third parties for manufacturing, and intellectual property protection[16](index=16&type=chunk) [Investor & Media Contact](index=3&type=section&id=Investor%20%26%20Media%20Contact) Provides contact information for investor and media inquiries - Investor & Media Contact: Daniel Kontoh-Boateng, DKB Partners, Tel: **862-213-1398**, dboateng@dkbpartners.net[17](index=17&type=chunk)

[PART I. FINANCIAL INFORMATION](index=4&type=section&id=PART%20I.%20FINANCIAL%20INFORMATION) 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](index=4&type=section&id=Item%201.%20Financial%20Statements) 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](index=4&type=section&id=Condensed%20Balance%20Sheets%20as%20of%20June%2030%2C%202025%20%28Unaudited%29%20and%20December%2031%2C%202024) 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](index=5&type=section&id=Condensed%20Statements%20of%20Operations%20for%20the%20three%20and%20six%20months%20ended%20June%2030%2C%202025%20and%202024%20%28Unaudited%29) 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](index=6&type=section&id=Condensed%20Statements%20of%20Stockholders%27%20Equity%20for%20the%20three%20and%20six%20months%20ended%20June%2030%2C%202025%20and%202024%20%28Unaudited%29) 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 2024[14](index=14&type=chunk) - Issuance of common stock pursuant to the ESPP resulted in **$24,999** in additional paid-in capital for the six months ended June 30, 2025[14](index=14&type=chunk) [Condensed Statements of Cash Flows](index=7&type=section&id=Condensed%20Statements%20of%20Cash%20Flows%20for%20the%20six%20months%20ended%20June%2030%2C%202025%20and%202024%20%28Unaudited%29) 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](index=8&type=section&id=Notes%20to%20Condensed%20Financial%20Statements%20%28Unaudited%29) This section provides explanatory notes to the unaudited condensed financial statements, detailing accounting policies and other relevant information [1. Organization and Basis of Presentation](index=8&type=section&id=1.%20Organization%20and%20Basis%20of%20Presentation) 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 gastroparesis[19](index=19&type=chunk)[20](index=20&type=chunk) - 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, 2025[22](index=22&type=chunk) - A **1-for-12** reverse stock split was effected on August 1, 2024, to regain compliance with Nasdaq's minimum bid price requirement[25](index=25&type=chunk)[26](index=26&type=chunk) [2. Summary of Significant Accounting Policies](index=9&type=section&id=2.%20Summary%20of%20Significant%20Accounting%20Policies) 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 amounts[27](index=27&type=chunk)[28](index=28&type=chunk) - Revenue from Gimoti sales is recognized net of variable consideration (rebates, discounts, co-pay assistance) when the customer obtains control of the product[38](index=38&type=chunk)[39](index=39&type=chunk)[40](index=40&type=chunk) - 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 operations[45](index=45&type=chunk)[46](index=46&type=chunk)[48](index=48&type=chunk) **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](index=13&type=section&id=3.%20Commitments%20and%20Contingencies) 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, 2025[51](index=51&type=chunk) **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](index=14&type=section&id=4.%20Stockholders%27%20Equity) 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 proceeds[54](index=54&type=chunk)[55](index=55&type=chunk) - 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, 2025[56](index=56&type=chunk)[57](index=57&type=chunk) - 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**, respectively[60](index=60&type=chunk)[62](index=62&type=chunk) **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](index=17&type=section&id=5.%20Commercial%20Services%20and%20Loan%20Agreements%20with%20Eversana) 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 responsibilities[73](index=73&type=chunk)[74](index=74&type=chunk) - 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](index=74&type=chunk) - The Eversana Agreement can be terminated if net profit is negative for two consecutive quarters (NPQTR)[77](index=77&type=chunk) - 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 days[78](index=78&type=chunk)[79](index=79&type=chunk) [6. Segment Information](index=19&type=section&id=6.%20Segment%20Information) 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 States[82](index=82&type=chunk)[83](index=83&type=chunk) **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](index=21&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) 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](index=21&type=section&id=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 Eversana[90](index=90&type=chunk) - 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 metoclopramide[91](index=91&type=chunk) - 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 Facility[95](index=95&type=chunk)[96](index=96&type=chunk) [Nasdaq Listing and Reverse Stock Split](index=23&type=section&id=Nasdaq%20Listing%20and%20Reverse%20Stock%20Split) 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, 2025[97](index=97&type=chunk) - 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, 2024[99](index=99&type=chunk)[100](index=100&type=chunk) [Recent Developments](index=25&type=section&id=Recent%20Developments) 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 deductions[101](index=101&type=chunk) - The company is assessing its impact but currently believes it will not materially affect its statement of operations[101](index=101&type=chunk) [Financial Operations Overview](index=25&type=section&id=Financial%20Operations%20Overview) 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 assistance[103](index=103&type=chunk)[104](index=104&type=chunk)[105](index=105&type=chunk) - 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 rates[106](index=106&type=chunk)[119](index=119&type=chunk) - New inbound prescriptions into the ASPN reimbursement center increased by **9.3%** QoQ to approximately **1,960** during the quarter ended June 30, 2025[107](index=107&type=chunk) - Research and development expenses have decreased since Gimoti's FDA approval, shifting to commercialization costs[112](index=112&type=chunk) - Future R&D expenses are expected to increase significantly with the initiation of a post-marketing commitment single-dose PK clinical trial[112](index=112&type=chunk) - Selling, general and administrative expenses are expected to increase as commercialization of Gimoti progresses and Eversana is reimbursed from net profits[115](index=115&type=chunk) [Critical Accounting Policies and Significant Judgments and Estimates](index=29&type=section&id=Critical%20Accounting%20Policies%20and%20Significant%20Judgments%20and%20Estimates) 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, 2024[118](index=118&type=chunk) [Results of Operations](index=29&type=section&id=Results%20of%20Operations) 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 rates[119](index=119&type=chunk)[124](index=124&type=chunk) - 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 period[122](index=122&type=chunk)[127](index=127&type=chunk) **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](index=31&type=section&id=Liquidity%20and%20Capital%20Resources) 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 Eversana[128](index=128&type=chunk)[129](index=129&type=chunk) - As of June 30, 2025, cash and cash equivalents were approximately **$12.1 million**[130](index=130&type=chunk) - 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](index=130&type=chunk) - 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](index=133&type=chunk) - Future funding requirements depend on commercialization costs, Gimoti's success, manufacturing capabilities, costs of post-marketing clinical trials, intellectual property maintenance, and potential collaboration arrangements[135](index=135&type=chunk) **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](index=34&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20about%20Market%20Risk) 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 risk[136](index=136&type=chunk) [Item 4. Controls and Procedures](index=34&type=section&id=Item%204.%20Controls%20and%20Procedures) 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, 2025[138](index=138&type=chunk) - 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 reporting[139](index=139&type=chunk) [PART II. OTHER INFORMATION](index=35&type=section&id=PART%20II.%20OTHER%20INFORMATION) This section covers legal proceedings, risk factors, equity sales, defaults, mine safety, other information, and exhibits [Item 1. Legal Proceedings](index=35&type=section&id=Item%201.%20Legal%20Proceedings) Evoke Pharma, Inc. reports no legal proceedings for the period - There are no legal proceedings to report[140](index=140&type=chunk) [Item 1A. Risk Factors](index=35&type=section&id=Item%201A.%20Risk%20Factors) 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 products[141](index=141&type=chunk) - 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 industry[147](index=147&type=chunk)[148](index=148&type=chunk) - 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 sales[149](index=149&type=chunk) - 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 products[151](index=151&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=37&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) 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 report[153](index=153&type=chunk) [Item 3. Defaults Upon Senior Securities](index=37&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) Evoke Pharma, Inc. reports no defaults upon senior securities for the period - There were no defaults upon senior securities to report[153](index=153&type=chunk) [Item 4. Mine Safety Disclosures](index=37&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) Evoke Pharma, Inc. states that mine safety disclosures are not applicable to its operations - Mine safety disclosures are not applicable to the company[153](index=153&type=chunk) [Item 5. Other Information](index=37&type=section&id=Item%205.%20Other%20Information) 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, 2025[154](index=154&type=chunk) [Item 6. Exhibits](index=38&type=section&id=Item%206.%20Exhibits) 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 Officers[158](index=158&type=chunk) [SIGNATURES](index=41&type=section&id=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, 2025[164](index=164&type=chunk)[165](index=165&type=chunk)

Core Insights - Evoke Pharma reported a 47% year-over-year increase in net product sales for Q2 2025, reaching approximately $3.8 million compared to $2.6 million in Q2 2024, indicating strong commercial performance of GIMOTI [1][4][9] - The company experienced a 20% increase in new prescribers since the same quarter last year, reflecting growing demand from both physicians and patients [2][9] - The refill rates for GIMOTI remained steady at around 70%, suggesting consistent therapeutic benefits for patients [9] Financial Performance - For Q2 2025, Evoke Pharma reported a net loss of approximately $1.6 million, or ($0.62) per share, compared to a net loss of $1.3 million, or ($0.93) per share, in Q2 2024 [4][22] - Selling, general, and administrative expenses rose to approximately $5.1 million in Q2 2025 from $3.7 million in Q2 2024, attributed to increased profit-sharing with EVERSANA and higher professional fees [5][22] - Total operating expenses for Q2 2025 were approximately $5.3 million, up from $3.8 million in the same period of 2024 [5][22] Cash Position and Outlook - As of June 30, 2025, Evoke Pharma had cash and cash equivalents of approximately $12.1 million, which is expected to fund operations into Q3 2026 based on current plans [6] - The company confirmed its full-year 2025 net product sales guidance of approximately $16 million, representing up to a 60% increase over 2024, driven by trends in prescription growth and refill rates [7]

Core Points - Evoke Pharma, Inc. has received a new U.S. patent for GIMOTI, extending market exclusivity to November 2038, which is nearly two years longer than the previous expiration date of December 2036 [1][2] - The patent covers the use of intranasal metoclopramide for treating moderate to severe symptoms of gastroparesis, enhancing the company's intellectual property position [3][2] - The company is committed to supporting the gastroparesis community and recognizes Gastroparesis Awareness Month in August [4] Company Overview - Evoke Pharma is a specialty pharmaceutical company focused on developing treatments for gastrointestinal disorders, specifically through its product GIMOTI, a nasal spray formulation of metoclopramide [5] - GIMOTI is the only FDA-approved drug in the U.S. for treating diabetic gastroparesis, a condition that affects millions globally and can lead to serious gastrointestinal symptoms [6] Product Information - GIMOTI is indicated for the relief of symptoms in adults with acute and recurrent diabetic gastroparesis, providing a non-oral treatment option for patients [7][6] - The patent's claims specifically address methods of treating gastroparesis symptoms through intranasal administration of metoclopramide [3]

Core Insights - Evoke Pharma, Inc. has received a Notice of Allowance from the USPTO for a patent application related to GIMOTI® nasal spray, extending patent exclusivity by an additional 6 years, expected to expire in December 2036 [1][2] Company Overview - Evoke Pharma is a specialty pharmaceutical company focused on developing treatments for gastrointestinal diseases, particularly through its product GIMOTI®, a nasal spray formulation of metoclopramide [6] - GIMOTI® is the only FDA-approved non-oral, self-administered formulation of metoclopramide, indicated for the relief of symptoms associated with acute and recurrent diabetic gastroparesis in adults [5][7] Product Significance - The new patent allowance enhances the GIMOTI® franchise by providing additional protection for its use in patients with moderate to severe symptoms of gastroparesis, a condition that complicates the absorption of oral medications [2][3] - GIMOTI® addresses a significant need in the market as gastroparesis affects millions globally, leading to serious gastrointestinal symptoms and complications [7] Market Commitment - The company is committed to supporting the gastroparesis community and will participate in Gastroparesis Awareness Month to improve treatment options and disease awareness [4]

PART I. FINANCIAL INFORMATION [Item 1. Financial Statements](index=4&type=section&id=Item%201.%20Financial%20Statements) The company's unaudited statements show sales growth but also net losses and substantial doubt about its going concern status [Condensed Balance Sheets](index=4&type=section&id=Condensed%20Balance%20Sheets) Total assets and stockholders' equity decreased as of March 31, 2025, primarily due to a reduction in cash Condensed Balance Sheet Data (Unaudited) | Account | March 31, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Cash and cash equivalents | $12,624,090 | $13,596,600 | | Total current assets | $16,230,875 | $17,237,897 | | Total assets | $16,375,945 | $17,519,007 | | Total current liabilities | $10,451,513 | $10,380,039 | | Total liabilities | $10,534,730 | $10,480,997 | | Total stockholders' equity | $5,841,215 | $7,038,010 | [Condensed Statements of Operations](index=5&type=section&id=Condensed%20Statements%20of%20Operations) Net product sales grew significantly year-over-year, while the net loss per share improved Q1 2025 vs Q1 2024 Statement of Operations (Unaudited) | Metric | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :--- | :--- | :--- | | Net product sales | $3,080,158 | $1,735,490 | | Loss from operations | $(1,301,743) | $(1,501,220) | | Net loss | $(1,306,178) | $(1,579,820) | | Net loss per share, basic and diluted | $(0.51) | $(2.09) | [Condensed Statements of Cash Flows](index=7&type=section&id=Condensed%20Statements%20of%20Cash%20Flows) Net cash used in operations decreased significantly, though financing activities provided minimal cash in Q1 2025 Q1 2025 vs Q1 2024 Cash Flow Summary (Unaudited) | Cash Flow Activity | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :--- | :--- | :--- | | Net cash used in operating activities | $(997,509) | $(2,579,390) | | Net cash provided by financing activities | $24,999 | $7,542,719 | | Net (decrease) increase in cash | $(972,510) | $4,963,329 | | Cash and cash equivalents at end of period | $12,624,090 | $9,702,755 | [Notes to Condensed Financial Statements](index=8&type=section&id=Notes%20to%20Condensed%20Financial%20Statements) Notes highlight a going concern risk, dependency on its sole product, and details of its partner agreement with Eversana - Management has concluded there is **substantial doubt about the Company's ability to continue as a going concern** for one year, due to recurring losses, negative cash flows, and the potential for its partner Eversana to terminate their agreement and demand repayment of a **$7.2 million loan** within 90 days[23](index=23&type=chunk) - A **1-for-12 reverse stock split** was effective on August 1, 2024, and all share and per-share data have been retroactively adjusted[26](index=26&type=chunk)[27](index=27&type=chunk) - Under the Eversana agreement, Evoke records sales for Gimoti and retains over **80% of net product profits** after both parties' costs are reimbursed, with unreimbursed commercialization costs owed to Eversana at approximately **$77.5 million** as of March 31, 2025[74](index=74&type=chunk) - The company has a **$5.0 million revolving credit facility** from Eversana, with **$7.2 million outstanding** including interest as of March 31, 2025, which is classified as a current liability due to the risk of accelerated repayment[23](index=23&type=chunk)[78](index=78&type=chunk)[80](index=80&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=21&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses strong sales growth for Gimoti®, ongoing going concern risks, and its current liquidity position - The company's existing cash of **$12.6 million** is expected to fund operations into Q2 2026, but this forecast excludes the potential early repayment of the Eversana loan, leading to **substantial doubt about its ability to continue as a going concern**[97](index=97&type=chunk) - The company regained compliance with Nasdaq's minimum bid price and minimum stockholders' equity requirements but is subject to a **discretionary panel monitor through June 4, 2025**[98](index=98&type=chunk)[101](index=101&type=chunk) Gimoti Sales Metrics - Q1 2025 vs Q1 2024 | Metric | Change | Detail | | :--- | :--- | :--- | | Net Product Sales | +77% | $3.1M in Q1 2025 vs $1.7M in Q1 2024 | | New Inbound Prescriptions | +25% | 1,793 new prescriptions in Q1 2025 | | Refill Rate | ~70% | For patients who have completed their first fill | | New Prescribers | +9.6% | Cumulative increase during Q1 2025 | [Results of Operations](index=28&type=section&id=Results%20of%20Operations) Q1 2025 saw a 77% increase in net product sales, offset by higher SG&A expenses tied to marketing and profit sharing Comparison of Operations for Three Months Ended March 31, (2025 vs 2024) | Item | 2025 | 2024 | $ Change | % Change | | :--- | :--- | :--- | :--- | :--- | | Net product sales | $3,080,158 | $1,735,490 | $1,344,668 | 77% | | Cost of goods sold | $41,613 | $92,529 | $(50,916) | -55% | | Research and development expenses | $42,783 | $4,645 | $38,138 | 821% | | Selling, general and administrative expenses | $4,297,505 | $3,139,536 | $1,157,969 | 37% | - The increase in SG&A was primarily due to a **$1.2 million rise in marketing and Eversana profit sharing** directly resulting from increased net product sales[121](index=121&type=chunk) [Liquidity and Capital Resources](index=30&type=section&id=Liquidity%20and%20Capital%20Resources) The company faces significant liquidity risk from a potential loan acceleration by its partner, creating substantial going concern doubt - The company has a **$5.0 million revolving credit facility** from Eversana, with **$7.2 million outstanding** including interest as of March 31, 2025, and repayment could be accelerated if Eversana exercises its termination right (NPQTR)[124](index=124&type=chunk)[125](index=125&type=chunk) - Management believes there is **substantial doubt about the company's ability to continue as a going concern** for one year due to the risk of the Eversana loan acceleration and ongoing losses[125](index=125&type=chunk) Cash Flow Summary Change (Q1 2025 vs Q1 2024) | Cash Flow Activity | Q1 2025 | Q1 2024 | $ Change | | :--- | :--- | :--- | :--- | | Net cash used in operating activities | $(997,509) | $(2,579,390) | $1,581,881 | | Net cash provided by financing activities | $24,999 | $7,542,719 | $(7,517,720) | [Quantitative and Qualitative Disclosures about Market Risk](index=32&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20about%20Market%20Risk) The company is exempt from this disclosure requirement as a smaller reporting company - The company is not required to provide information for this item as it qualifies as a **smaller reporting company**[131](index=131&type=chunk) [Controls and Procedures](index=32&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that disclosure controls and procedures were effective with no material changes to internal controls - Based on an evaluation as of March 31, 2025, the Chief Executive Officer and Chief Financial Officer concluded that the company's **disclosure controls and procedures were effective** at a reasonable assurance level[134](index=134&type=chunk) - **No changes in internal control over financial reporting** occurred during the quarter ended March 31, 2025, that materially affected, or are reasonably likely to materially affect, internal controls[135](index=135&type=chunk) PART II. OTHER INFORMATION [Legal Proceedings](index=35&type=section&id=Item%201.%20Legal%20Proceedings) The company reports no current legal proceedings - None[137](index=137&type=chunk) [Risk Factors](index=35&type=section&id=Item%201A.%20Risk%20Factors) A new risk factor was added concerning potential impacts from U,S, tariff and import/export regulations - A new risk factor has been added regarding changes to **U.S. tariff and import/export regulations**, which could negatively affect the business due to reliance on international third-party manufacturers for Gimoti in Italy and France[138](index=138&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=35&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) The company reports no unregistered sales of equity securities during the period - None[139](index=139&type=chunk) [Other Information](index=35&type=section&id=Item%205.%20Other%20Information) No officers or directors adopted, modified, or terminated Rule 10b5-1 trading plans during the quarter - No officers or directors adopted, modified, or terminated any **Rule 10b5-1 trading plans** during the three months ended March 31, 2025[140](index=140&type=chunk) [Exhibits](index=36&type=section&id=Item%206.%20Exhibits) This section lists all exhibits filed with the report, including officer certifications and XBRL data

Executive Summary](index=1&type=section&id=1.%20Executive%20Summary) Evoke Pharma reported strong Q1 2025 financial results with significant net product sales growth and improved net loss, alongside strengthening corporate governance and sustained GIMOTI commercial momentum [Q1 2025 Performance Highlights](index=1&type=section&id=1.1.%20Q1%202025%20Performance%20Highlights) Evoke Pharma reported strong Q1 2025 financial results, with net product sales increasing significantly year-over-year, driven by growing prescriber adoption and repeat patient use of GIMOTI. The company also saw an improvement in its net loss Q1 2025 Performance Metrics | Metric | Q1 2025 ($) | Q1 2024 ($) | YoY Change (%) | | :---------------- | :---------- | :---------- | :--------- | | Net Product Sales | $3.1 million | $1.7 million | +77% | | Net Loss | $(1.3) million | $(1.6) million | -18.75% | | Net Loss per Share | $(0.51) | $(2.09) | -75.6% | - Fill rate increased **73% year-over-year**, and the total prescriber base grew by **44%** compared to Q1 last year, indicating strong underlying demand drivers[2](index=2&type=chunk)[6](index=6&type=chunk) [Recent Business Developments](index=1&type=section&id=1.2.%20Recent%20Business%20Developments) The company strengthened its corporate governance with a new board appointment and highlighted sustained commercial momentum for GIMOTI, particularly among GLP-1 patient populations - Appointed Greg Pyszczymuka to the Board of Directors, bringing extensive experience in commercial strategy and revenue growth[3](index=3&type=chunk) - GIMOTI demonstrated solid momentum with strong repeat usage, increasing prescription depth, and stable conversion rates[6](index=6&type=chunk) - Maintained strategic emphasis on GLP-1 patient populations, where the need for effective non-oral options continues to grow[6](index=6&type=chunk) First Quarter 2025 Financial Review](index=1&type=section&id=2.%20First%20Quarter%202025%20Financial%20Review) Evoke Pharma's Q1 2025 financial review highlights substantial net product sales growth, increased operating expenses, a reduced net loss, and a stable cash position projected to fund operations into Q2 2026 [Net Product Sales](index=1&type=section&id=2.1.%20Net%20Product%20Sales) Evoke Pharma reported a substantial increase in net product sales for Q1 2025, reflecting strong commercial execution and market adoption of GIMOTI Net Product Sales Data | Metric | Q1 2025 ($) | Q1 2024 ($) | YoY Change (%) | | :---------------- | :---------- | :---------- | :--------- | | Net Product Sales | $3,080,158 | $1,735,490 | +77.4% | [Operating Expenses](index=2&type=section&id=2.2.%20Operating%20Expenses) Total operating expenses increased in Q1 2025, primarily driven by higher selling, general, and administrative (SG&A) costs due to increased professional fees and profit-sharing activities linked to higher net product sales Operating Expenses Breakdown | Metric | Q1 2025 ($) | Q1 2024 ($) | YoY Change (%) | | :-------------------------------- | :---------- | :---------- | :--------- | | Selling, General, and Administrative | $4,297,505 | $3,139,536 | +36.9% | | Total Operating Expenses | $4,381,901 | $3,236,710 | +35.4% | - The increase in SG&A was due to higher professional fees and reimbursement and profit-sharing activity with EVERSANA as a result of an increase in net product sales[7](index=7&type=chunk) [Net Loss and Earnings Per Share (EPS)](index=1&type=section&id=2.3.%20Net%20Loss%20and%20Earnings%20Per%20Share%20(EPS)) Evoke Pharma reduced its net loss in Q1 2025 compared to the prior year, despite increased operating expenses, leading to a significantly improved net loss per share Net Loss and EPS Summary | Metric | Q1 2025 ($) | Q1 2024 ($) | YoY Change (%) | | :-------------------------------- | :----------- | :----------- | :--------- | | Net Loss | $(1,306,178) | $(1,579,820) | -17.3% | | Net Loss per Share (basic & diluted) | $(0.51) | $(2.09) | -75.6% | - Weighted-average shares used to compute basic and diluted net loss per share increased to 2,548,684 in Q1 2025 from 756,808 in Q1 2024[23](index=23&type=chunk) [Liquidity and Cash Position](index=2&type=section&id=2.4.%20Liquidity%20and%20Cash%20Position) As of March 31, 2025, Evoke Pharma maintained a cash position of $12.6 million and projects its existing cash and future GIMOTI sales to fund operations into Q2 2026 Cash and Cash Equivalents | Metric | March 31, 2025 ($) | | :------------------------ | :------------- | | Cash and cash equivalents | $12,624,090 | - Existing cash and cash equivalents, along with future cash flows from GIMOTI net product sales, are believed to be sufficient to fund operations into the second quarter of 2026[8](index=8&type=chunk) Business Operations and Outlook](index=1&type=section&id=3.%20Business%20Operations%20and%20Outlook) Evoke Pharma's business operations in Q1 2025 showed strong GIMOTI adoption and commercial execution, a strengthened corporate governance, and a reiterated positive 2025 financial outlook [Commercial Execution and GIMOTI Adoption](index=1&type=section&id=3.1.%20Commercial%20Execution%20and%20GIMOTI%20Adoption) GIMOTI continued to demonstrate strong commercial momentum in Q1 2025, marked by increased prescriber confidence, expanded pharmacy partnerships, and a strategic focus on specific patient populations - GIMOTI showed solid momentum in Q1 with strong repeat usage, increasing prescription depth, and stable conversion rates[6](index=6&type=chunk) - Realized a **73% year-over-year** increase in fill rate, driven by expanded pharmacy partnerships and reduced fulfillment friction[6](index=6&type=chunk) - Grew the total prescriber base by **44%**, with increased provider confidence in GIMOTI's efficacy and convenience, and maintained strategic emphasis on GLP-1 patient populations[6](index=6&type=chunk) [Corporate Governance Update](index=1&type=section&id=3.2.%20Corporate%20Governance%20Update) Evoke Pharma strengthened its leadership team with the appointment of a new director to its Board, bringing valuable commercial strategy and revenue growth experience - Appointed Greg Pyszczymuka to the Board of Directors, whose extensive experience in commercial strategy and revenue growth is expected to be valuable[3](index=3&type=chunk) [2025 Financial Outlook](index=2&type=section&id=3.3.%202025%20Financial%20Outlook) Evoke Pharma reiterated its 2025 net product sales guidance, projecting significant growth based on current business momentum and expectations, while acknowledging potential external challenges - Reiterates 2025 net product sales guidance of approximately **$16 million**, reflecting a **60% increase over 2024**[9](index=9&type=chunk) - Confidence in continued growth is driven by focused execution, expanded provider engagement, and GIMOTI's ongoing relevance in a growing diabetic patient population[10](index=10&type=chunk) - Guidance is dependent on current business, growth rates, reimbursement, prescription fills, and external factors such as macroeconomic environment, supply chain constraints, and inflationary pressures[9](index=9&type=chunk) Company and Product Information](index=2&type=section&id=4.%20Company%20and%20Product%20Information) This section provides an overview of Evoke Pharma as a specialty pharmaceutical company and detailed information about its primary product, GIMOTI, including its indication and safety profile [About Evoke Pharma, Inc.](index=2&type=section&id=4.1.%20About%20Evoke%20Pharma,%20Inc.) Evoke Pharma is a specialty pharmaceutical company focused on developing and commercializing treatments for gastrointestinal disorders, with GIMOTI as its primary product for diabetic gastroparesis - Evoke is a specialty pharmaceutical company focused primarily on the development of drugs to treat GI disorders and diseases[10](index=10&type=chunk) - The company 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[10](index=10&type=chunk) - Diabetic gastroparesis is a GI disorder affecting **millions**, where the stomach takes too long to empty, and metoclopramide remains the only FDA-approved drug in the United States to treat it[11](index=11&type=chunk) [About GIMOTI® (metoclopramide) nasal spray](index=2&type=section&id=4.2.%20About%20GIMOTI%C2%AE%20(metoclopramide)%20nasal%20spray) GIMOTI is a nasal spray formulation of metoclopramide indicated for acute and recurrent diabetic gastroparesis, but carries a serious warning for tardive dyskinesia and has several contraindications and potential adverse reactions [Indication and Mechanism](index=2&type=section&id=4.2.1.%20Indication%20and%20Mechanism) GIMOTI is a nasal spray formulation of metoclopramide indicated for the relief of symptoms in adults with acute and recurrent diabetic gastroparesis - GIMOTI is indicated for the relief of symptoms in adults with acute and recurrent diabetic gastroparesis[12](index=12&type=chunk) - It is a nasal spray formulation of metoclopramide, which was previously only available in oral and injectable forms and is the only FDA-approved drug for gastroparesis in the US[10](index=10&type=chunk)[11](index=11&type=chunk) [Important Safety Information and Contraindications](index=2&type=section&id=4.2.2.%20Important%20Safety%20Information%20and%20Contraindications) GIMOTI carries a serious warning for tardive dyskinesia and is contraindicated in several patient populations, with common adverse reactions including dysgeusia, headache, and fatigue - WARNING: TARDIVE DYSKINESIA (TD) – Metoclopramide can cause TD, a serious, often irreversible movement disorder, with risk increasing with treatment duration and cumulative dosage. Treatment should be avoided for longer than **12 weeks**[12](index=12&type=chunk) - GIMOTI is contraindicated in pediatric patients, those with moderate/severe hepatic or renal impairment, history of TD, gastrointestinal hemorrhage/obstruction/perforation, pheochromocytoma, epilepsy, or hypersensitivity to metoclopramide[13](index=13&type=chunk)[17](index=17&type=chunk) - Most common adverse reactions (≥**5%**) for GIMOTI are dysgeusia, headache, and fatigue[13](index=13&type=chunk) Condensed Financial Statements](index=5&type=section&id=5.%20Condensed%20Financial%20Statements) The condensed financial statements for Q1 2025 reflect a decrease in total assets and stockholders' equity, significant growth in net product sales with a reduced net loss, and decreased cash usage from operations [Balance Sheets](index=5&type=section&id=5.1.%20Balance%20Sheets) The balance sheet shows a decrease in total assets and stockholders' equity from December 31, 2024, to March 31, 2025, primarily due to a reduction in cash and cash equivalents and an accumulated deficit Condensed Balance Sheet | Metric | March 31, 2025 ($) | December 31, 2024 ($) | Change ($) | | :-------------------------- | :------------- | :---------------- | :------- | | Cash and cash equivalents | $12,624,090 | $13,596,600 | $(972,510) | | Total current assets | $16,230,875 | $17,237,897 | $(1,007,022) | | Total assets | $16,375,945 | $17,519,007 | $(1,143,062) | | Total current liabilities | $10,451,513 | $10,380,039 | $71,474 | | Total liabilities | $10,534,730 | $10,480,997 | $53,733 | | Total stockholders' equity | $5,841,215 | $7,038,010 | $(1,196,795) | | Accumulated deficit | $(130,097,810) | $(128,791,632) | $(1,306,178) | [Statements of Operations](index=6&type=section&id=5.2.%20Statements%20of%20Operations) For Q1 2025, Evoke Pharma reported a significant increase in net product sales and a reduction in net loss compared to Q1 2024, despite higher operating expenses, leading to a substantially improved net loss per share Condensed Statements of Operations | Metric | 2025 ($) | 2024 ($) | YoY Change (%) | | :-------------------------------- | :----------- | :----------- | :--------- | | Net product sales | $3,080,158 | $1,735,490 | +77.4% | | Cost of goods sold | $41,613 | $92,529 | -55.0% | | Research and development | $42,783 | $4,645 | +821.1% | | Selling, general and administrative | $4,297,505 | $3,139,536 | +36.9% | | Total operating expenses | $4,381,901 | $3,236,710 | +35.4% | | Loss from operations | $(1,301,743) | $(1,501,220) | -13.2% | | Net loss | $(1,306,178) | $(1,579,820) | -17.3% | | Net loss per share (basic & diluted) | $(0.51) | $(2.09) | -75.6% | [Statements of Cash Flows](index=7&type=section&id=5.3.%20Statements%20of%20Cash%20Flows) In Q1 2025, net cash used in operating activities decreased significantly compared to Q1 2024, while net cash provided by financing activities was minimal, resulting in a net decrease in cash and cash equivalents for the period Condensed Statements of Cash Flows | Metric | 2025 ($) | 2024 ($) | Change ($) | | :------------------------------------ | :----------- | :----------- | :----------- | | Net cash used in operating activities | $(997,509) | $(2,579,390) | $(1,581,881) | | Net cash provided by financing activities | $24,999 | $7,542,719 | $(7,517,720) | | Net (decrease) increase in cash | $(972,510) | $4,963,329 | $(5,935,839) | | Cash and cash equivalents at end of period | $12,624,090 | $9,702,755 | $2,921,335 | - The significant decrease in net cash provided by financing activities in 2025 compared to 2024 is due to the absence of proceeds from offerings and warrant amendments that occurred in Q1 2024[25](index=25&type=chunk) Safe Harbor Statement](index=3&type=section&id=6.%20Safe%20Harbor%20Statement) This section provides a cautionary notice regarding forward-looking statements, highlighting inherent risks and uncertainties that could cause actual results to differ from projections [Forward-Looking Statements and Risks](index=3&type=section&id=6.1.%20Forward-Looking%20Statements%20and%20Risks) This section serves as a cautionary notice regarding forward-looking statements made in the press release, emphasizing that actual results may differ due to inherent risks and uncertainties in Evoke's business - Statements included in the press release that are not historical facts are forward-looking, identifiable by terms such as 'may,' 'will,' 'should,' 'expect,' 'plan,' 'anticipate,' 'could,' 'intend,' 'target,' 'project,' 'contemplates,' 'believes,' 'estimates,' 'predicts,' 'potential' or 'continue'[15](index=15&type=chunk) - Forward-looking statements include guidance regarding 2025 net product sales, potential future provider engagement, GIMOTI's relevance, commercialization plans, and expected cash runway[16](index=16&type=chunk) - Actual results may differ due to risks such as inability to achieve guidance, decreased demand for GIMOTI, financing needs, potential termination of EVERSANA agreements, dependence on third-party manufacturers, and GIMOTI's sole product status[16](index=16&type=chunk)[18](index=18&type=chunk) Investor & Media Contact](index=4&type=section&id=7.%20Investor%20%26%20Media%20Contact) This section provides essential contact information for investor and media inquiries [Contact Information](index=4&type=section&id=7.1.%20Contact%20Information) This section provides the contact details for investor and media inquiries - Contact Person: Daniel Kontoh-Boateng, DKB Partners[19](index=19&type=chunk) - Contact Details: Tel: 862-213-1398, Email: dboateng@dkbpartners.net[19](index=19&type=chunk)