Evoke Pharma(EVOK)

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Evoke Pharma Announces Closing of $7.5 Million Public Offering
Newsfilter· 2024-02-14 12:30
SOLANA BEACH, Calif., Feb. 14, 2024 (GLOBE NEWSWIRE) -- Evoke Pharma, Inc. (NASDAQ:EVOK), a specialty pharmaceutical company focused primarily on treatments for gastrointestinal (GI) diseases with an emphasis on GIMOTI® (metoclopramide) nasal spray, announced today that it has closed an underwritten public offering led by Nantahala Capital Management, with participation by other fundamental investors, for gross proceeds of up to $30 million, which included an initial upfront funding of approximately $7.5 mi ...
Evoke Pharma Announces Pricing of Underwritten Public Offering of up to $30 Million
Newsfilter· 2024-02-09 12:30
SOLANA BEACH, Calif., Feb. 09, 2024 (GLOBE NEWSWIRE) -- Evoke Pharma, Inc. (NASDAQ:EVOK), a specialty pharmaceutical company focused primarily on treatments for gastrointestinal (GI) diseases with an emphasis on GIMOTI® (metoclopramide) nasal spray, announced today that it has priced an underwritten public offering led by Nantahala Capital Management, with participation by other fundamental investors, for gross proceeds of up to $30 million, that includes initial upfront funding of approximately $7.5 millio ...
Evoke Pharma(EVOK) - 2023 Q3 - Quarterly Report
2023-11-08 16:00
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Commission File Number 001-36075 EVOKE PHARMA, INC. (Exact name of registrant as specified in its charter) (State or other jurisdiction of incorporation) Delaware 20-8447886 (IRS Employ ...
Evoke Pharma(EVOK) - 2023 Q2 - Quarterly Report
2023-08-09 16:00
[PART I. FINANCIAL INFORMATION](index=3&type=section&id=PART%20I.%20FINANCIAL%20INFORMATION) [Item 1. Financial Statements](index=3&type=section&id=Item%201.%20Financial%20Statements) The financial statements reveal increased net product sales but continued net losses, with cash and equity significantly declining, raising going concern and Nasdaq compliance issues [Condensed Balance Sheets](index=3&type=section&id=Condensed%20Balance%20Sheets) As of June 30, 2023, total assets decreased to $9.0 million, primarily due to reduced cash, while liabilities increased and stockholders' equity significantly declined to $0.5 million Condensed Balance Sheet Highlights (in thousands) | Account | June 30, 2023 (Unaudited) | December 31, 2022 | | :--- | :--- | :--- | | Cash and cash equivalents | $7,006 | $9,844 | | Total current assets | $8,927 | $11,722 | | Total assets | $8,980 | $11,851 | | Total current liabilities | $2,081 | $1,655 | | Total liabilities | $8,441 | $7,767 | | Total stockholders' equity | $538 | $4,085 | [Condensed Statements of Operations](index=4&type=section&id=Condensed%20Statements%20of%20Operations) Net product sales grew significantly in Q2 and H1 2023, with the net loss narrowing slightly for both periods compared to the prior year Condensed Statements of Operations Highlights (in thousands) | Metric | Q2 2023 | Q2 2022 | H1 2023 | H1 2022 | | :--- | :--- | :--- | :--- | :--- | | Net product sales | $1,131 | $462 | $1,942 | $880 | | Loss from operations | $(1,784) | $(2,113) | $(3,940) | $(4,164) | | Net loss | $(1,868) | $(2,233) | $(4,111) | $(4,407) | | Net loss per share | $(0.56) | $(0.71) | $(1.23) | $(1.50) | [Condensed Statements of Cash Flows](index=6&type=section&id=Condensed%20Statements%20of%20Cash%20Flows) Net cash used in operations slightly improved in H1 2023, with no financing activities, leading to a net decrease in cash and an ending balance of $7.0 million Six Months Ended June 30 Cash Flow Summary (in thousands) | Cash Flow Item | 2023 | 2022 | | :--- | :--- | :--- | | Net cash used in operating activities | $(2,837) | $(2,989) | | Net cash provided by financing activities | $0 | $7,295 | | Net (decrease) increase in cash | $(2,837) | $4,306 | | Cash at end of period | $7,006 | $13,451 | [Notes to Condensed Financial Statements](index=7&type=section&id=Notes%20to%20Condensed%20Financial%20Statements) Notes highlight substantial doubt about going concern, Nasdaq non-compliance, and significant commercialization costs and loan obligations with Eversana - The company believes there is substantial doubt about its ability to continue as a going concern for one year, citing recurring losses, negative cash flows, and the need to raise additional funds[20](index=20&type=chunk) - On May 24, 2023, the company received a notice from Nasdaq for non-compliance with the minimum stockholders' equity requirement of **$2.5 million**. Nasdaq granted an extension until November 20, 2023, to regain compliance[24](index=24&type=chunk)[25](index=25&type=chunk)[26](index=26&type=chunk) - The company has a commercial services agreement with Eversana to commercialize Gimoti. As of June 30, 2023, unreimbursed commercialization costs to Eversana were approximately **$57.2 million**[61](index=61&type=chunk)[62](index=62&type=chunk) - The company has a **$5 million** revolving credit facility with Eversana, which was fully drawn in 2020. The facility is secured by all personal property other than intellectual property[69](index=69&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=15&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses Gimoti's sales growth, ongoing operating losses, critical liquidity issues, and the substantial doubt about going concern, alongside Nasdaq delisting risks [Overview](index=15&type=section&id=Overview) Evoke Pharma, a specialty pharmaceutical company, focuses on its sole product, Gimoti, for diabetic gastroparesis, commercialized through Eversana, despite ongoing losses - The company's sole product is Gimoti® (metoclopramide) nasal spray, the first nasally-administered product for relief of symptoms in adults with acute and recurrent diabetic gastroparesis[18](index=18&type=chunk)[76](index=76&type=chunk) - Commercial sales of Gimoti in the U.S. are managed by its partner, Eversana Life Science Services, LLC, under an agreement extending to December 31, 2026[76](index=76&type=chunk)[78](index=78&type=chunk) [Results of Operations](index=19&type=section&id=Results%20of%20Operations) Q2 2023 saw increased net product sales and SG&A expenses due to marketing, while R&D decreased, reflecting similar trends for the six-month period Comparison of Three Months Ended June 30, 2023 and 2022 (in thousands) | Metric | 2023 | 2022 | Change | | :--- | :--- | :--- | :--- | | Net product sales | $1,131 | $462 | $670 | | Research and development expenses | $92 | $191 | $(99) | | Selling, general and administrative expenses | $2,766 | $2,315 | $451 | Comparison of Six Months Ended June 30, 2023 and 2022 (in thousands) | Metric | 2023 | 2022 | Change | | :--- | :--- | :--- | :--- | | Net product sales | $1,942 | $880 | $1,062 | | Research and development expenses | $159 | $233 | $(74) | | Selling, general and administrative expenses | $5,614 | $4,720 | $894 | - The increase in SG&A expenses in Q2 2023 was primarily due to higher costs for marketing and Eversana profit sharing, which amounted to approximately **$1.1 million**[104](index=104&type=chunk) [Liquidity and Capital Resources](index=21&type=section&id=Liquidity%20and%20Capital%20Resources) With $7.0 million cash, the company faces substantial doubt about going concern, requiring additional capital, and is working to regain Nasdaq compliance by November 2023 - Management concluded there is substantial doubt about the company's ability to continue as a going concern[116](index=116&type=chunk) - Cash and cash equivalents of approximately **$7.0 million** as of June 30, 2023, are expected to be sufficient to fund operations only into the first quarter of 2024[82](index=82&type=chunk)[116](index=116&type=chunk) - The company received a notice from Nasdaq for non-compliance with the minimum stockholders' equity requirement and has until November 20, 2023, to regain compliance[121](index=121&type=chunk) - The company's ability to sell shares under its Form S-3 shelf registration is limited by the SEC's 'baby shelf rules' because its public float is less than **$75 million**[111](index=111&type=chunk)[112](index=112&type=chunk) [Item 3. Quantitative and Qualitative Disclosures about Market Risk](index=23&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20about%20Market%20Risk) As a smaller reporting company, Evoke Pharma is exempt from providing quantitative and qualitative disclosures about market risk - The company is not required to provide information on market risk as it qualifies as a smaller reporting company[126](index=126&type=chunk) [Item 4. Controls and Procedures](index=23&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that disclosure controls and procedures were effective as of June 30, 2023, with no material changes to internal control over financial reporting - Management, including the CEO and Chief Business Officer, concluded that the company's disclosure controls and procedures were effective as of June 30, 2023[128](index=128&type=chunk)[129](index=129&type=chunk) - No material changes to the company's internal control over financial reporting were identified during the quarter ended June 30, 2023[130](index=130&type=chunk) [PART II. OTHER INFORMATION](index=24&type=section&id=PART%20II.%20OTHER%20INFORMATION) [Item 1. Legal Proceedings](index=24&type=section&id=Item%201.%20Legal%20Proceedings) The company successfully dismissed patent litigation against Teva Pharmaceuticals, preventing FDA approval of Teva's generic Gimoti until Evoke's patent expires in 2030 - In response to Teva's ANDA filing for a generic version of Gimoti, the company initiated patent infringement litigation in April 2022[51](index=51&type=chunk)[131](index=131&type=chunk) - The litigation against Teva was dismissed in January 2023 after Teva converted to a Paragraph III certification, which prevents FDA approval of its generic product until 2030[51](index=51&type=chunk)[131](index=131&type=chunk) [Item 1A. Risk Factors](index=24&type=section&id=Item%201A.%20Risk%20Factors) Key risks include the need for substantial additional funding to avoid liquidation and the potential delisting from Nasdaq due to non-compliance with equity requirements - The company requires substantial additional funding and may be forced to liquidate, dissolve, or wind down operations if it cannot raise capital[132](index=132&type=chunk) - The company is at risk of being delisted from the Nasdaq Capital Market for failing to meet the minimum stockholders' equity requirement. It has been granted an extension until November 20, 2023, to regain compliance[136](index=136&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=25&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) The company reported no unregistered sales of equity securities during the period - None[138](index=138&type=chunk) [Item 6. Exhibits](index=27&type=section&id=Item%206.%20Exhibits) This section lists the exhibits filed with the Form 10-Q, including corporate governance documents and officer certifications
Evoke Pharma(EVOK) - 2023 Q1 - Quarterly Report
2023-05-14 16:00
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(EVOK) - 2022 Q4 - Earnings Call Transcript
2023-03-21 22:39
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 ...
Evoke Pharma(EVOK) - 2022 Q4 - Annual Report
2023-03-20 16:00
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(EVOK) - 2022 Q3 - Earnings Call Transcript
2022-11-10 01:46
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 ...
Evoke Pharma(EVOK) - 2022 Q3 - Quarterly Report
2022-11-08 16:00
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(EVOK) - 2022 Q2 - Earnings Call Transcript
2022-08-10 22:56
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 ...