UNITED STATES SECURITIES AND EXCHANGE COMMISSION (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Commission File Number 001-36075 EVOKE PHARMA, INC. Washington, D.C. 20549 FORM 10-Q (Exact name of registrant as specified in its charter) (State or other jurisdiction of incorporation) Delaware 20-8447886 (IRS Employer I ...

Evoke Pharma, Inc. (NASDAQ:EVOK) Q4 2022 Earnings Conference Call March 21, 2023 4:30 PM ET Company Participants Daniel Kontoh-Boateng - Investor Relations David Gonyer - Chief Executive Officer Chris Quesenberry - GIMOTI's Chief Commercial Officer, EVERSANA Matthew D'Onofrio - Chief Business Officer Conference Call Participants Yale Jen - Laidlaw & Company Operator Good afternoon, and welcome to the Evoke Pharma's Fourth Quarter and Full Year 2022 Earnings Conference Call. Currently, all callers have been ...

PART I [Business](index=4&type=section&id=Item%201.%20Business) The company's operations center on its sole product, Gimoti™, a nasally-administered treatment for diabetic gastroparesis [Overview](index=4&type=section&id=Overview) The company's sole product is Gimoti™, an FDA-approved nasal spray for diabetic gastroparesis commercialized via a partnership - The company's sole product is **Gimoti (metoclopramide) nasal spray**, the first and only nasally-administered product for the relief of symptoms in adults with acute and recurrent diabetic gastroparesis[11](index=11&type=chunk) - Gimoti received **FDA approval on June 19, 2020**, and U.S. commercial sales launched in October 2020 through a partnership with Eversana[11](index=11&type=chunk)[18](index=18&type=chunk) - The nasal spray formulation is designed to bypass the digestive system for more predictable absorption, which is beneficial for gastroparesis patients who may have erratic absorption of oral tablets or experience nausea and vomiting[16](index=16&type=chunk) - The company has incurred **operating losses every year since inception** and expects these losses to continue until Gimoti revenues exceed expenses[19](index=19&type=chunk) [Business Strategy](index=5&type=section&id=Business%20Strategy) The business strategy focuses on commercializing Gimoti in the U.S., developing a lower dosage, and seeking international partners - The company's core strategies are: * Successfully commercialize Gimoti in the U.S. through its partnership with Eversana * Develop a lower dosage strength of Gimoti based on an FDA post-marketing commitment * Seek partnerships to accelerate Gimoti's potential, including outside the U.S * In-license or acquire additional clinical or commercial stage GI product candidates[20](index=20&type=chunk) [The Gastrointestinal Market and Gastroparesis](index=6&type=section&id=The%20Gastrointestinal%20Market%20and%20Gastroparesis) Gastroparesis represents a significant market with rising healthcare costs and a high unmet need for effective outpatient treatments - The prevalence of gastroparesis is estimated to be **up to 4% of the U.S. population**, with diabetes being a leading cause (29% of cases)[14](index=14&type=chunk)[29](index=29&type=chunk) - Hospitalizations for gastroparesis have risen significantly, with median costs climbing from approximately $6,000 in 1994 to **$24,500 in 2014**[28](index=28&type=chunk) - There is a high level of interest in effective outpatient options for gastroparesis, as the market is currently served mainly by oral metoclopramide, with approximately **3.0 million U.S. prescriptions per year** (as of 2015)[35](index=35&type=chunk) [Commercialization](index=9&type=section&id=Commercialization) Gimoti is commercialized in the U.S. through a partnership with Eversana, which handles all sales, marketing, and distribution - The company has a commercial services agreement with Eversana to market, sell, and distribute Gimoti in the U.S., with the term extended to **December 31, 2026**[43](index=43&type=chunk)[45](index=45&type=chunk) - Evoke records sales and retains **over 80% of net product profits** after costs are reimbursed; as of Dec 31, 2022, unreimbursed commercialization costs to Eversana were approximately **$48.4 million**[44](index=44&type=chunk) - The company transitioned to the vitaCare platform in 2022 to manage prescription fulfillment, which helps patients with coverage verification and co-pay assistance[49](index=49&type=chunk)[53](index=53&type=chunk) - A June 2022 market research study showed that **87% of all healthcare provider respondents** indicated an intent to prescribe Gimoti[54](index=54&type=chunk)[55](index=55&type=chunk) - An October 2022 patient study found Gimoti scored better or equal on all treatment experience measures compared to other common gastroparesis treatments[57](index=57&type=chunk) [Manufacturing](index=11&type=section&id=Manufacturing) The company outsources all manufacturing, relying on third-party contractors for both the finished product and active ingredient - The company outsources all manufacturing and does not own or operate its own facilities[59](index=59&type=chunk) - A manufacturing agreement with **Patheon UK Limited** is in place for commercial quantities of Gimoti, with an initial term until December 31, 2025[60](index=60&type=chunk) - **Cosma S.p.A.** is the exclusive commercial supplier of metoclopramide for Gimoti under a Master Supply Agreement[62](index=62&type=chunk) [Competition](index=12&type=section&id=Competition) Gimoti's primary competition is generic oral metoclopramide, with several other companies developing potential new treatments - Gimoti competes directly with various forms of metoclopramide, the only other product approved in the U.S. to treat gastroparesis, which is available generically[65](index=65&type=chunk) Gastroparesis Treatment Development Pipeline | Product | Class | Route | Company | Status | | :--- | :--- | :--- | :--- | :--- | | Tradipitant | NK-1 antagonist | oral | Vanda | Phase 3 (did not meet primary endpoint) | | Velusetrag | 5-HT4 receptor agonist | oral | Theravance/Alfasigma | Phase 2 | | Metopimazine | D2/D3 antagonist | oral | Neurogastrx | Phase 2 | | CIN-102 | Deuterated Domperidone | oral | CinRx | Phase 2 | | TAK-906 | D2/D3 antagonist | oral | Takeda/Altos | Phase 2 | [Intellectual Property and Proprietary Rights](index=13&type=section&id=Intellectual%20Property%20and%20Proprietary%20Rights) The company's intellectual property portfolio for Gimoti includes multiple U.S. and international patents with expirations through 2038 - The company holds U.S. patents for Gimoti's nasal formulations and methods of use, with expiration dates expected no earlier than **2029, 2032, and 2038**[75](index=75&type=chunk) - International patents have been granted in Europe, Canada, Japan, Russia, and Mexico[74](index=74&type=chunk) - The company acquired the worldwide rights for Gimoti from Questcor (now Mallinckrodt); a final **$5 million milestone payment** was made in July 2021, terminating further royalty obligations[80](index=80&type=chunk)[81](index=81&type=chunk) [Government Regulation](index=14&type=section&id=Government%20Regulation) The company operates in a highly regulated environment subject to extensive oversight from the FDA and other government bodies - Pharmaceutical products are subject to extensive regulation by the FDA, governing research, development, manufacturing (cGMP), approval, labeling, and marketing[82](index=82&type=chunk) - Gimoti was approved under the **Section 505(b)(2) pathway**, which allows reliance on FDA's prior findings of safety and effectiveness for an approved drug[100](index=100&type=chunk) - The company is subject to significant post-approval requirements, including reporting, cGMP compliance, and potential Phase 4 studies; the Gimoti label includes a **black box warning** for tardive dyskinesia[95](index=95&type=chunk)[162](index=162&type=chunk) - The company must comply with various healthcare laws, including the federal **Anti-Kickback Statute, False Claims Act**, and government drug pricing programs like MDRP and the 340B program[108](index=108&type=chunk)[117](index=117&type=chunk)[119](index=119&type=chunk) - The **Inflation Reduction Act of 2022 (IRA)** will require drug price negotiations with Medicare starting in 2026 and impose rebates for price increases that outpace inflation[125](index=125&type=chunk) [Risk Factors](index=22&type=section&id=Item%201A.%20Risk%20Factors) The company faces significant risks related to its dependence on a single product, need for funding, and reliance on partners - The company's business is **entirely dependent on the success of its only product, Gimoti**, which may never generate sufficient sales to be profitable[134](index=134&type=chunk) - Recurring losses have raised **substantial doubt about the company's ability to continue as a going concern**, requiring additional funding that is not assured[249](index=249&type=chunk)[250](index=250&type=chunk) - The company **relies on its partner, Eversana**, for all sales, marketing, and distribution, and has no internal capabilities in these areas[143](index=143&type=chunk) - The company faces substantial competition from **well-established, generically available forms of metoclopramide**[173](index=173&type=chunk) - The company is subject to extensive and ongoing government regulation, and failure to comply could result in significant penalties and inhibit the ability to commercialize Gimoti[162](index=162&type=chunk)[164](index=164&type=chunk) - In 2022, Teva Pharmaceuticals filed an ANDA for a generic version of Gimoti, leading to a patent infringement lawsuit that was later dismissed after Teva delayed its potential launch to 2030[228](index=228&type=chunk)[279](index=279&type=chunk) [Properties](index=46&type=section&id=Item%202.%20Properties) The company leases approximately 3,000 square feet of office space in Solana Beach, California under a short-term lease - The company leases approximately **3,000 square feet** of office space in Solana Beach, California[278](index=278&type=chunk) - The lease was most recently amended in August 2022 and expires in **October 2023**[278](index=278&type=chunk) [Legal Proceedings](index=46&type=section&id=Item%203.%20Legal%20Proceedings) Patent infringement litigation against Teva was dismissed after Teva converted its generic filing, delaying potential market entry to 2030 - In February 2022, Teva Pharmaceuticals filed an ANDA for a generic version of Gimoti, challenging two of the company's Orange Book-listed patents[279](index=279&type=chunk) - Evoke filed a patent infringement lawsuit against Teva in April 2022; Teva later converted its filing to a Paragraph III certification, delaying potential generic approval until **2030**[279](index=279&type=chunk) - The litigation against Teva was **dismissed in January 2023**[279](index=279&type=chunk) PART II [Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities](index=47&type=section&id=Item%205.%20Market%20for%20Registrant's%20Common%20Equity%2C%20Related%20Stockholder%20Matters%20and%20Issuer%20Purchases%20of%20Equity%20Securities) The company's common stock trades on Nasdaq under "EVOK," and it has never paid cash dividends and does not plan to - The company's common stock is traded on the Nasdaq Capital Market under the symbol **'EVOK'**[283](index=283&type=chunk) - The company has **never declared or paid cash dividends** and does not intend to in the foreseeable future[284](index=284&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=48&type=section&id=Item%207.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Net product sales increased in 2022, but continued net losses raise substantial doubt about the company's going concern status [Results of Operations](index=55&type=section&id=Results%20of%20Operations) Net product sales increased by $0.9 million in 2022, while operating expenses also rose, driven by higher SG&A costs Comparison of Years Ended December 31, 2022 and 2021 | | 2022 | 2021 | Increase/(Decrease) | | :--- | :--- | :--- | :--- | | **Net product sales** | $2,508,645 | $1,618,076 | $890,569 | | **Research and development expense** | $300,789 | $590,476 | $(289,687) | | **Selling general and administrative expense** | $9,623,599 | $8,851,129 | $772,470 | - Net product sales increased by approximately **56% year-over-year**; excluding a one-time $0.7 million sale for research purposes in 2021, the increase was **179%**[307](index=307&type=chunk)[326](index=326&type=chunk) [Liquidity and Capital Resources](index=56&type=section&id=Liquidity%20and%20Capital%20Resources) The company has substantial doubt about its ability to continue as a going concern, with cash expected to last only into Q3 2023 - As of December 31, 2022, the company had cash and cash equivalents of approximately **$9.8 million**[296](index=296&type=chunk) - Management concluded there is **substantial doubt about the company's ability to continue as a going concern**, with cash sufficient to fund operations only into Q3 2023[339](index=339&type=chunk) - In 2022, the company sold 621,697 shares of common stock under its ATM Sales Agreement, receiving net proceeds of approximately **$7.3 million**[331](index=331&type=chunk)[346](index=346&type=chunk) - The company's ability to raise funds via its shelf registration is limited by the SEC's **"baby shelf rules"** because its public float is below $75 million[332](index=332&type=chunk)[333](index=333&type=chunk) - The company has a **$5 million loan from Eversana**, which bears 10% annual interest and terminates on June 19, 2025[336](index=336&type=chunk)[337](index=337&type=chunk) [Financial Statements and Supplementary Data](index=57&type=section&id=Item%208.%20Financial%20Statements%20and%20Supplementary%20Data) The auditor's report expresses substantial doubt about the company's ability to continue as a going concern due to recurring losses Selected Balance Sheet Data (as of December 31) | | 2022 | 2021 | | :--- | :--- | :--- | | Cash and cash equivalents | $9,843,699 | $9,144,710 | | Total Assets | $11,851,488 | $10,573,162 | | Total Liabilities | $7,766,839 | $7,018,068 | | Total Stockholders' Equity | $4,084,649 | $3,555,094 | Selected Statement of Operations Data (for the Year Ended December 31) | | 2022 | 2021 | | :--- | :--- | :--- | | Net product sales | $2,508,645 | $1,618,076 | | Total operating expenses | $10,294,782 | $9,769,723 | | Loss from operations | $(7,786,137) | $(8,151,647) | | Net loss | $(8,224,130) | $(8,537,952) | | Net loss per share | $(2.62) | $(3.18) | - The independent auditor's report includes a **going concern uncertainty paragraph** due to recurring losses and negative cash flows from operations[377](index=377&type=chunk) [Controls and Procedures](index=57&type=section&id=Item%209A.%20Controls%20and%20Procedures) Management concluded that the company's disclosure controls and internal control over financial reporting were effective as of year-end - Management concluded that the company's **disclosure controls and procedures were effective** as of December 31, 2022[355](index=355&type=chunk) - Based on an evaluation using the COSO 2013 framework, management concluded that the company's **internal control over financial reporting was effective** as of December 31, 2022[358](index=358&type=chunk) PART III This section incorporates by reference information from the company's definitive proxy statement for its 2023 Annual Meeting of Stockholders [Directors, Executive Officers and Corporate Governance](index=58&type=section&id=Item%2010.%20Directors%2C%20Executive%20Officers%20and%20Corporate%20Governance) Information regarding directors, executive officers, and corporate governance is incorporated by reference from the 2023 proxy statement - Information required by this item will be contained in the definitive proxy statement for the 2023 Annual Meeting of Stockholders and is **incorporated by reference**[363](index=363&type=chunk) [Executive Compensation](index=58&type=section&id=Item%2011.%20Executive%20Compensation) Information regarding executive compensation is incorporated by reference from the company's upcoming 2023 definitive proxy statement - Information required by this item will be contained in the definitive proxy statement for the 2023 Annual Meeting of Stockholders and is **incorporated by reference**[365](index=365&type=chunk) [Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters](index=58&type=section&id=Item%2012.%20Security%20Ownership%20of%20Certain%20Beneficial%20Owners%20and%20Management%20and%20Related%20Stockholder%20Matters) Information regarding security ownership is incorporated by reference from the company's upcoming 2023 definitive proxy statement - Information required by this item will be contained in the definitive proxy statement for the 2023 Annual Meeting of Stockholders and is **incorporated by reference**[366](index=366&type=chunk) [Certain Relationships, Related Transactions and Director Independence](index=58&type=section&id=Item%2013.%20Certain%20Relationships%2C%20Related%20Transactions%20and%20Director%20Independence) Information regarding related party transactions and director independence is incorporated by reference from the 2023 proxy statement - Information required by this item will be contained in the definitive proxy statement for the 2023 Annual Meeting of Stockholders and is **incorporated by reference**[367](index=367&type=chunk) [Principal Accounting Fees and Services](index=58&type=section&id=Item%2014.%20Principal%20Accounting%20Fees%20and%20Services) Information regarding principal accounting fees and services is incorporated by reference from the 2023 proxy statement - Information required by this item will be contained in the definitive proxy statement for the 2023 Annual Meeting of Stockholders and is **incorporated by reference**[368](index=368&type=chunk) PART IV [Exhibits, Financial Statement Schedules](index=59&type=section&id=Item%2015.%20Exhibits%2C%20Financial%20Statement%20Schedules) This section lists the financial statements and exhibits filed as part of the annual report, including material contracts - This section includes the company's financial statements and the report of its independent registered public accounting firm, BDO USA, LLP[371](index=371&type=chunk) - A list of all exhibits filed with the Form 10-K is provided, including the Amended and Restated Certificate of Incorporation, commercial agreements with Eversana, and executive employment agreements[372](index=372&type=chunk)[483](index=483&type=chunk)

Evoke Pharma, Inc. (NASDAQ:EVOK) Q3 2022 Results Earnings Conference Call November 10, 2022 4:30 PM ET Company Participants Daniel Kontoh-Boateng - Investor Relations, DKB Partners David Gonyer - President and Chief Executive Officer Chris Quesenberry - Chief Commercial Officer Matthew D'Onofrio - Executive Vice President, Chief Business Officer, Secretary and Treasurer Conference Call Participants Operator Good afternoon. And welcome to the Evoke Pharma Third Quarter 2022 Earnings Conference Call. Currentl ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2022 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Commission File Number 001-36075 EVOKE PHARMA, INC. (Exact name of registrant as specified in its charter) (State or other jurisdiction of incorporation) (IRS Employer Identification No ...

Evoke Pharma, Inc. (NASDAQ:EVOK) Q2 2022 Earnings Conference Call August 10, 2022 4:30 PM ET Company Participants David Gonyer – Chief Executive Officer Chris Quesenberry – Chief Commercial Officer Matthew D’Onofrio – Chief Business Officer Conference Call Participants Unidentified Company Representative Good afternoon. And thank you for participating in Evoke Pharma's conference call today. With me today are David Gonyer, Evoke's Chief Executive Officer, Chris Quesenberry, GIMOTI’s Chief Commercial Office ...

[PART I. FINANCIAL INFORMATION](index=3&type=section&id=PART%20I.%20FINANCIAL%20INFORMATION) [Financial Statements](index=3&type=section&id=Item%201.%20Financial%20Statements) The unaudited condensed financial statements for the period ended June 30, 2022, show increased net product sales but continued net losses, with cash and equivalents at **$13.5 million** and a going concern uncertainty [Condensed Balance Sheets](index=3&type=section&id=Condensed%20Balance%20Sheets) As of June 30, 2022, cash and cash equivalents increased to **$13.5 million**, total assets grew to **$14.4 million**, and stockholders' equity rose to **$7.2 million** due to financing activities Condensed Balance Sheet Data (Unaudited) | Account | June 30, 2022 | December 31, 2021 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $13,450,949 | $9,144,710 | | Total current assets | $14,404,396 | $10,560,734 | | **Total assets** | **$14,404,396** | **$10,573,162** | | **Liabilities & Stockholders' Equity** | | | | Total current liabilities | $1,353,146 | $1,405,773 | | Total liabilities | $7,213,386 | $7,018,068 | | Total stockholders' equity | $7,191,010 | $3,555,094 | | **Total liabilities and stockholders' equity** | **$14,404,396** | **$10,573,162** | [Condensed Statements of Operations](index=4&type=section&id=Condensed%20Statements%20of%20Operations) For the three and six months ended June 30, 2022, net product sales significantly grew, and net loss narrowed to **$2.2 million** for Q2 2022 and **$4.4 million** for the six-month period Statement of Operations Highlights (Unaudited) | Metric | Three Months Ended June 30, 2022 | Three Months Ended June 30, 2021 | Six Months Ended June 30, 2022 | Six Months Ended June 30, 2021 | | :--- | :--- | :--- | :--- | :--- | | Net product sales | $461,795 | $236,635 | $880,175 | $327,056 | | Loss from operations | ($2,112,632) | ($2,168,996) | ($4,163,805) | ($4,759,445) | | Net loss | ($2,233,380) | ($2,290,643) | ($4,407,045) | ($4,896,138) | | Net loss per share | ($0.71) | ($0.85) | ($1.50) | ($1.85) | [Condensed Statements of Cash Flows](index=6&type=section&id=Condensed%20Statements%20of%20Cash%20Flows) For the six months ended June 30, 2022, net cash used in operating activities improved to **$3.0 million**, with **$7.3 million** provided by financing activities, resulting in a **$4.3 million** net increase in cash Cash Flow Summary (Unaudited) | Cash Flow Activity | Six Months Ended June 30, 2022 | Six Months Ended June 30, 2021 | | :--- | :--- | :--- | | Net cash used in operating activities | ($2,988,737) | ($4,463,608) | | Net cash provided by financing activities | $7,294,976 | $13,115,608 | | Net increase in cash and cash equivalents | $4,306,239 | $8,652,000 | | Cash and cash equivalents at end of period | $13,450,949 | $16,720,939 | - The company has incurred recurring losses and negative cash flows since inception, raising substantial doubt about its ability to continue as a going concern for one year, requiring additional funding[18](index=18&type=chunk) - In May 2022, the company effected a **1-for-12 reverse stock split** to regain compliance with Nasdaq's minimum bid price requirement, successfully achieved in June 2022[22](index=22&type=chunk) - The company is in litigation with Teva Pharmaceuticals, alleging patent infringement after Teva submitted an Abbreviated New Drug Application (ANDA) for a generic version of Gimoti[30](index=30&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=15&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses Gimoti's commercialization, noting an **11% quarter-over-quarter sales increase** in Q2 2022, but acknowledges a history of losses and substantial doubt about going concern, with current cash projected to last only into Q2 2023 - The company believes its existing cash of approximately **$13.5 million** as of June 30, 2022, will be sufficient to fund operations into the second quarter of 2023, but substantial doubt exists about its ability to continue as a going concern[41](index=41&type=chunk)[53](index=53&type=chunk) - Gimoti net product sales were approximately **$462,000** in Q2 2022, an **11% increase** from Q1 2022, with new inbound prescriptions growing **24%** and a patient refill rate of approximately **67%**[46](index=46&type=chunk) Comparison of Operations (Six Months Ended June 30) | Metric | 2022 | 2021 | Change | | :--- | :--- | :--- | :--- | | Net product sales | $880,175 | $327,056 | +$553,119 | | Research and development expenses | $233,194 | $473,054 | -$239,860 | | Selling, general and administrative expenses | $4,720,251 | $4,480,443 | +$239,808 | - During the six months ended June 30, 2022, the company sold **621,697 shares** of common stock under its ATM Sales Agreement, receiving net proceeds of approximately **$7.3 million**[53](index=53&type=chunk)[56](index=56&type=chunk) [Quantitative and Qualitative Disclosures about Market Risk](index=23&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20about%20Market%20Risk) As a smaller reporting company, Evoke Pharma, Inc. is not required to provide the information for this item - The company is not required to provide information for this item as it qualifies as a smaller reporting company[58](index=58&type=chunk) [Controls and Procedures](index=23&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that the company's disclosure controls and procedures were effective as of June 30, 2022, with no material changes to internal control over financial reporting during the quarter - Based on an evaluation as of June 30, 2022, the Chief Executive Officer and Chief Business Officer concluded that the company's disclosure controls and procedures were effective at the reasonable assurance level[59](index=59&type=chunk) - No changes in internal control over financial reporting occurred during the quarter ended June 30, 2022, that have materially affected, or are reasonably likely to materially affect, internal controls[59](index=59&type=chunk) [PART II. OTHER INFORMATION](index=23&type=section&id=PART%20II.%20OTHER%20INFORMATION) [Legal Proceedings](index=23&type=section&id=Item%201.%20Legal%20Proceedings) The company is involved in patent litigation against Teva Pharmaceuticals, alleging infringement after Teva submitted an ANDA for a generic version of Gimoti - On February 25, 2022, Teva Pharmaceuticals submitted an ANDA for a generic version of Gimoti, with Paragraph IV certifications alleging that two of Evoke's patents are invalid or will not be infringed[60](index=60&type=chunk) - In April 2022, Evoke initiated litigation against Teva in the U.S. District Court for the District of New Jersey, alleging patent infringement, which Teva has denied and counterclaimed[62](index=62&type=chunk) [Risk Factors](index=24&type=section&id=Item%201A.%20Risk%20Factors) The primary risk factor is the company's need for substantial additional funding to continue operations, with existing cash projected to last only into Q2 2023, risking liquidation if capital cannot be raised - The company requires substantial additional funding and may be unable to raise capital when needed, which would force it to liquidate, dissolve, or wind down operations[63](index=63&type=chunk) - Cash and cash equivalents of **$13.5 million** as of June 30, 2022, are expected to fund operations only into the second quarter of 2023[63](index=63&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=24&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) There were no unregistered sales of equity securities during the period - None[63](index=63&type=chunk) [Defaults Upon Senior Securities](index=24&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) There were no defaults upon senior securities during the period - None[63](index=63&type=chunk) [Mine Safety Disclosures](index=25&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to the company - Not applicable[64](index=64&type=chunk) [Other Information](index=25&type=section&id=Item%205.%20Other%20Information) There is no other information to report for the period - None[64](index=64&type=chunk) [Exhibits](index=26&type=section&id=Item%206.%20Exhibits) This section provides an index of the exhibits filed with this Quarterly Report on Form 10-Q, including corporate governance documents, certifications, and XBRL data files

Evoke Pharma, Inc. EVOK Q1 2022 Earnings Conference Call May 10, 2022 4:30 PM ET Company Participants David Gonyer – Chief Executive Officer Chris Quesenberry – Chief Commercial Officer, EVERSANA Matthew D'Onofrio – Chief Business Officer Daniel Kontoh-Boateng – Investor Relations Conference Call Participants Yale Jen – Laidlaw and Company Mitchell Kapoor – H.C. Wainwright & Co., LLC Operator Please stand by. Your program is about to begin. [Operator Instructions] Good afternoon and welcome to the Evoke Pha ...

[PART I. FINANCIAL INFORMATION](index=3&type=section&id=PART%20I.%20FINANCIAL%20INFORMATION) [Item 1. Financial Statements](index=3&type=section&id=Item%201.%20Financial%20Statements) Unaudited Q1 2022 financials show increased sales, continued net loss, negative cash flow, and substantial doubt about going concern [Condensed Balance Sheets](index=3&type=section&id=Condensed%20Balance%20Sheets) Total assets decreased to $9.0 million by March 31, 2022, primarily due to reduced cash, with total equity declining to $1.9 million Condensed Balance Sheet Data (in USD) | Financial Metric | March 31, 2022 (Unaudited) | December 31, 2021 | | :--- | :--- | :--- | | Cash and cash equivalents | $7,701,201 | $9,144,710 | | Total current assets | $9,026,270 | $10,560,734 | | Total assets | $9,026,270 | $10,573,162 | | Total current liabilities | $1,356,676 | $1,405,773 | | Total liabilities | $7,092,259 | $7,018,068 | | Total stockholders' equity | $1,934,011 | $3,555,094 | [Condensed Statements of Operations](index=4&type=section&id=Condensed%20Statements%20of%20Operations) Net product sales significantly increased to $418,380 in Q1 2022, narrowing the net loss to $2.17 million from $2.61 million year-over-year Condensed Statement of Operations (in USD) | Metric | Three Months Ended March 31, 2022 | Three Months Ended March 31, 2021 | | :--- | :--- | :--- | | Net product sales | $418,380 | $90,421 | | Total operating expenses | $2,469,552 | $2,680,871 | | Loss from operations | ($2,051,172) | ($2,590,450) | | Net loss | ($2,173,665) | ($2,605,495) | | Net loss per share | ($0.07) | ($0.08) | [Condensed Statements of Stockholders' Equity](index=5&type=section&id=Condensed%20Statements%20of%20Stockholders%27%20Equity) Stockholders' equity decreased to $1.93 million by March 31, 2022, primarily due to a $2.17 million net loss, partially offset by stock-based compensation - The net loss for the quarter of **$2,173,665** was the primary driver for the reduction in total stockholders' equity[13](index=13&type=chunk) - In contrast, for the three months ended March 31, 2021, stockholders' equity increased significantly from a deficit of **($3.2 million)** to **$7.8 million**, mainly due to the issuance of common stock that raised net proceeds of approximately **$13.1 million**[13](index=13&type=chunk)[47](index=47&type=chunk) [Condensed Statements of Cash Flows](index=6&type=section&id=Condensed%20Statements%20of%20Cash%20Flows) Net cash used in operations improved to $1.6 million in Q1 2022, but minimal financing activities led to a $1.4 million net cash decrease for the quarter Condensed Statement of Cash Flows (in USD) | Cash Flow Activity | Three Months Ended March 31, 2022 | Three Months Ended March 31, 2021 | | :--- | :--- | :--- | | Net cash used in operating activities | ($1,615,030) | ($2,953,119) | | Net cash provided by financing activities | $171,521 | $13,070,154 | | Net (decrease) increase in cash | ($1,443,509) | $10,117,035 | | Cash at end of period | $7,701,201 | $18,185,974 | [Notes to Condensed Financial Statements](index=7&type=section&id=Notes%20to%20Condensed%20Financial%20Statements) Notes disclose Gimoti® as the sole product, substantial doubt about going concern, a Nasdaq delisting notice, and patent litigation against Teva Pharmaceuticals - The company has incurred recurring losses and negative cash flows, leading to **substantial doubt about its ability to continue as a going concern** for one year[22](index=22&type=chunk) - In February 2022, Teva Pharmaceuticals submitted an ANDA for a generic version of Gimoti, leading Evoke to initiate patent infringement litigation in April 2022[45](index=45&type=chunk) - The company has a commercial services agreement with Eversana to commercialize Gimoti, with unreimbursed commercialization costs to Eversana approximately **$32.7 million** as of March 31, 2022[56](index=56&type=chunk) - The company received a delisting notice from Nasdaq in December 2021 for its stock price closing below **$1.00** for 30 consecutive days, and plans a **1-for-12 reverse stock split** to regain compliance[26](index=26&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=15&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses Gimoti commercialization, significant Q1 2022 sales growth, and ongoing 'going concern' issues, with cash projected to last only into Q2 2023 [Overview](index=15&type=section&id=Overview) Evoke Pharma, focused on Gimoti®, faces substantial doubt about its going concern status, with current cash funding operations only into Q2 2023, necessitating additional financing - The company's sole product is **Gimoti (metoclopramide) nasal spray**, the first and only nasally-administered product for acute and recurrent diabetic gastroparesis[62](index=62&type=chunk) - The company has a commercialization agreement with Eversana, amended in February 2022 to extend the term to **December 31, 2026**, and increase the net product profit retained by Evoke[62](index=62&type=chunk) - Based on the current operating plan, existing cash of **$7.7 million** as of March 31, 2022, plus subsequent ATM proceeds, is expected to fund operations into the **second quarter of 2023**, raising substantial doubt about its ability to continue as a going concern[64](index=64&type=chunk) [Results of Operations](index=19&type=section&id=Results%20of%20Operations) Q1 2022 saw a $328,000 increase in net product sales due to enhanced promotional activities, while R&D expenses decreased and SG&A slightly rose Comparison of Operations (in USD) | Metric | Three Months Ended March 31, 2022 | Three Months Ended March 31, 2021 | Change | | :--- | :--- | :--- | :--- | | Net product sales | $418,380 | $90,421 | +$327,959 | | Research and development expenses | $41,717 | $277,825 | -$236,108 | | Selling, general and administrative expenses | $2,405,075 | $2,338,295 | +$66,780 | - The increase in net product sales was primarily driven by increased educational and promotional activities of the Eversana sales force[79](index=79&type=chunk) [Liquidity and Capital Resources](index=21&type=section&id=Liquidity%20and%20Capital%20Resources) With $7.7 million cash, the company raised $7.3 million via ATM but faces a 'going concern' warning, with cash only into Q2 2023, and plans a reverse stock split - From January 1, 2022, through May 6, 2022, the company sold **7,460,397 shares** of common stock under its ATM Sales Agreement, receiving net proceeds of approximately **$7.3 million**[82](index=82&type=chunk) - Management concluded there is **substantial doubt about the company's ability to continue as a going concern**, with cash sufficient to fund operations only into the **second quarter of 2023**[84](index=84&type=chunk) - The company received a Nasdaq delisting notice for its stock price being below **$1.00** and intends to effect a **1-for-12 reverse stock split** on May 23, 2022, to regain compliance[84](index=84&type=chunk) - The company has a **$5 million revolving credit facility** from Eversana, from which it borrowed the full **$5 million** in 2020[84](index=84&type=chunk) [Item 3. Quantitative and Qualitative Disclosure about Market Risk](index=23&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosure%20about%20Market%20Risk) As a smaller reporting company, Evoke Pharma is exempt from providing this specific market risk disclosure - The company is not required to provide information for this item as it qualifies as a smaller reporting company[90](index=90&type=chunk) [Item 4. Controls and Procedures](index=23&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that disclosure controls and procedures were effective as of March 31, 2022, with no material changes to internal controls - Based on an evaluation as of March 31, 2022, the Chief Executive Officer and Chief Business Officer concluded that the company's disclosure controls and procedures were **effective at the reasonable assurance level**[92](index=92&type=chunk) - There were **no changes in internal control over financial reporting** during the quarter ended March 31, 2022, that materially affected, or are reasonably likely to materially affect, internal controls[93](index=93&type=chunk) [PART II. OTHER INFORMATION](index=25&type=section&id=PART%20II.%20OTHER%20INFORMATION) [Item 1. Legal Proceedings](index=25&type=section&id=Item%201.%20Legal%20Proceedings) The company initiated patent infringement litigation against Teva Pharmaceuticals in April 2022 after Teva filed an ANDA for a generic Gimoti - On February 25, 2022, Teva Pharmaceuticals submitted an ANDA for a generic version of Gimoti, challenging U.S. Patent Nos. **8,334,281** and **11,02,0361**[94](index=94&type=chunk) - In April 2022, Evoke Pharma initiated litigation against Teva in the U.S. District Court for the District of New Jersey over the validity and infringement of the patents covering Gimoti[94](index=94&type=chunk) [Item 1A. Risk Factors](index=25&type=section&id=Item%201A.%20Risk%20Factors) The company faces a critical need for substantial additional funding, as existing cash is only sufficient into Q2 2023, risking liquidation without new capital - The company requires **substantial additional funding** and may be unable to raise capital when needed, which could force it to liquidate or wind down operations[95](index=95&type=chunk) - Cash on hand as of March 31, 2022, plus subsequent ATM proceeds, is projected to be sufficient to fund operations only into the **second quarter of 2023**[95](index=95&type=chunk) - The business is entirely dependent on the success of Gimoti, and failure to secure financing or successfully commercialize the product could lead to a **complete loss of investment**[95](index=95&type=chunk) [Item 6. Exhibits](index=27&type=section&id=Item%206.%20Exhibits) This section lists various exhibits filed with the Form 10-Q, including corporate governance documents and officer certifications

Evoke Pharma, Inc. (NASDAQ:EVOK) Q4 2021 Earnings Conference Call March 8, 2022 4:30 PM ET Company Participants Dave Gonyer – Chief Executive Officer Matt D’Onfrio – Chief Business Officer Chris Quesenberry – Gimoti’s Chief Commercial Officer from EVERSANA Conference Call Participants Yale Jen – Laidlaw Mitchell Kapoor – Wainwright Operator Gentlemen, today's conference will resume momentarily. Please hold. And we now have today's management on the call. Please go ahead. Daniel Kontoh-Boateng Good afternoo ...