Evoke Pharma(EVOK)

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Evoke Pharma(EVOK) - 2021 Q4 - Annual Report
2022-03-08 21:42
| --- | --- | --- | |-----------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------|-----------------------------------------------------| | Evoke (Exact Name of \nDelaware (State or Other Jurisdiction of Incorporation or Organization) | Pharma, Inc. Registrant as Specified in its Charter) | 20-8447886 (I.R.S. Employer Identification No.) | | 420 Stevens Avenue, Suite 370 Solana Beach, ...
Evoke Pharma(EVOK) - 2021 Q3 - Earnings Call Transcript
2021-11-11 01:15
Evoke Pharma, Inc. (NASDAQ:EVOK) Q3 2021 Earnings Conference Call November 10, 2021 4:30 PM ET Company Participants Daniel Kontoh-Boateng – Investor Relations Dave Gonyer – Chief Executive Officer Matt D'Onofrio – Chief Business Officer Chris Quesenberry – Chief Commercial Officer-GIMOTI, EVERSANA Conference Call Participants Mitchell Kapoor – H.C. Wainwright Yale Jen – Laidlaw and Company Daniel Kontoh-Boateng Good afternoon and welcome to Evoke Pharma's Third Quarter 2021 Earnings Conference Call and Audi ...
Evoke Pharma(EVOK) - 2021 Q3 - Quarterly Report
2021-11-10 21:16
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, 2021 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Commission File Number 001-36075 | --- | --- | |--------------------------------------------------------------------------------------------------|-------------------------------------- ...
Evoke Pharma(EVOK) - 2021 Q2 - Earnings Call Transcript
2021-08-13 01:05
Evoke Pharma, Inc. (NASDAQ:EVOK) Q2 2021 Results Conference Call August 12, 2021 4:30 PM ET Company Participants Christine Petraglia - The Ruth Group David Gonyer - Chief Executive Officer Matt D'Onofrio - Chief Business Officer Chris Quesenberry - Chief Commercial Officer, Gimoti Conference Call Participants Yale Jen - Laidlaw & Company Operator Good day and thank you for standing by. Welcome to the Evoke Pharma's Q2 2021 Earnings Conference Call. At this time, all participants are in a listen-only mode. A ...
Evoke Pharma(EVOK) - 2021 Q2 - Quarterly Report
2021-08-12 20:19
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 June 30, 2021 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Commission File Number 001-36075 | --- | --- | |--------------------------------------------------------------------------------------------------|---------------------------------------| | ...
Evoke Pharma(EVOK) - 2021 Q1 - Earnings Call Transcript
2021-05-13 02:42
Evoke Pharma, Inc. (NASDAQ:EVOK) Q1 2021 Earnings Conference Call May 12, 2021 4:30 PM ET Company Participants Christine Petraglia - The Ruth Group David Gonyer - Co-Founder, CEO, President & Director Christopher Quesenberry - Chief Commercial Officer, Gimoti Matthew D'Onofrio - Co-Founder, Chief Business Officer, Executive VP, Treasurer & Secretary Conference Call Participants Yale Jen - Laidlaw & Company Operator Good afternoon, and thank you for joining Evoke Pharma's First Quarter 2021 Earnings Conferen ...
Evoke Pharma(EVOK) - 2021 Q1 - Quarterly Report
2021-05-12 20:11
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2021 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE EXCHANGE ACT OF 1934 Commission File Number 001-36075 EVOKE PHARMA, INC. (Exact name of registrant as specified in its charter) Delaware 20-8447886 (State or other jurisdiction of incorporation) (IRS Employer Identificati ...
Evoke Pharma(EVOK) - 2020 Q4 - Earnings Call Transcript
2021-03-12 03:29
Evoke Pharma, Inc. (NASDAQ:EVOK) Q4 2020 Results Conference Call March 11, 2021 4:30 PM ET Company Participants Dave Gonyer - Chief Executive Officer Matt D’Onofrio - Chief Business Officer Chris Quesenberry - Chief Commercial Officer, Eversana Conference Call Participants Yale Jen - Laidlaw and Company Operator Good afternoon, and welcome to Evoke Pharma’s Fourth Quarter and Full-year 2020 Earnings Conference Call and Audio Webcast. With me today are Dave Gonyer, Evoke’s Chief Executive Officer; and Matt ...
Evoke Pharma(EVOK) - 2020 Q3 - Quarterly Report
2020-11-10 13:30
PART I. FINANCIAL INFORMATION [Item 1. Financial Statements](index=3&type=section&id=Item%201.%20Financial%20Statements) The unaudited financial statements show a net loss of $10.9 million for the first nine months of 2020, leading to a stockholders' deficit of $1.92 million [Condensed Balance Sheets](index=3&type=section&id=Condensed%20Balance%20Sheets) As of September 30, 2020, total liabilities surged to $8.67 million, turning stockholders' equity into a $1.92 million deficit Condensed Balance Sheet Highlights (Unaudited) | Account | September 30, 2020 | December 31, 2019 | | :--- | :--- | :--- | | **Total Current Assets** | $6,714,784 | $6,245,539 | | **Total Assets** | $6,750,899 | $6,395,628 | | **Total Current Liabilities** | $6,621,309 | $2,015,083 | | **Total Liabilities** | $8,674,314 | $2,015,083 | | **Total Stockholders' (Deficit) Equity** | ($1,923,415) | $4,380,545 | - Key drivers for the increase in total liabilities include a new **$5,000,000 milestone payable** and a **$2,000,000 note payable**, which were not present at the end of 2019[8](index=8&type=chunk) [Condensed Statements of Operations](index=4&type=section&id=Condensed%20Statements%20of%20Operations) The company's net loss nearly doubled to $10.89 million for the nine months ended September 30, 2020, driven by higher R&D and G&A expenses Statement of Operations Summary (Unaudited) | Metric | Nine Months Ended Sep 30, 2020 | Nine Months Ended Sep 30, 2019 | | :--- | :--- | :--- | | Research and development | $6,450,979 | $2,774,924 | | General and administrative | $4,387,284 | $2,955,371 | | **Loss from operations** | **($10,838,263)** | **($5,730,295)** | | **Net loss** | **($10,886,809)** | **($5,707,427)** | | **Net loss per share** | **($0.43)** | **($0.26)** | [Condensed Statements of Stockholders' (Deficit) Equity](index=5&type=section&id=Condensed%20Statements%20of%20Stockholders'%20(Deficit)%20Equity) Stockholders' equity shifted from a $4.38 million surplus to a $1.92 million deficit, primarily due to a $10.89 million net loss - The company's equity position shifted from a positive **$4,380,545** at the start of 2020 to a deficit of **($1,923,415)** at the end of Q3 2020[14](index=14&type=chunk) - The primary drivers of the change in equity were the **net loss of $10,886,809** and proceeds from an At-The-Market offering of **$3,309,116**[14](index=14&type=chunk) [Condensed Statements of Cash Flows](index=6&type=section&id=Condensed%20Statements%20of%20Cash%20Flows) Net cash from financing activities of $5.5 million offset cash used in operations, resulting in a net cash increase of $0.6 million Cash Flow Summary (Unaudited) | Cash Flow Activity | Nine Months Ended Sep 30, 2020 | Nine Months Ended Sep 30, 2019 | | :--- | :--- | :--- | | Net cash used in operating activities | ($4,918,503) | ($4,614,403) | | Net cash provided by financing activities | $5,535,326 | $5,800,201 | | **Net increase in cash** | **$616,823** | **$1,185,798** | | **Cash at end of period** | **$6,280,656** | **$6,504,802** | [Notes to Condensed Financial Statements](index=7&type=section&id=Notes%20to%20Condensed%20Financial%20Statements) The notes disclose substantial doubt about the company's ability to continue as a going concern, with cash sufficient only into Q2 2021 - The company's sole product, Gimoti™, received FDA approval on June 19, 2020, and U.S. commercial sales launched in October 2020 through its partner Eversana[20](index=20&type=chunk) - Management believes there is **substantial doubt about the company's ability to continue as a going concern** for one year, as existing cash is only sufficient to fund operations into the second quarter of 2021[21](index=21&type=chunk) - Following FDA approval, the company recorded a **$5 million payable to Mallinckrodt**, due on June 19, 2021, as a milestone payment for the Gimoti technology acquisition[33](index=33&type=chunk) - The company entered into a commercial services agreement with Eversana and a related **$5 million revolving credit facility**, from which it borrowed $2 million in June 2020[44](index=44&type=chunk)[46](index=46&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=13&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management highlights the launch of Gimoti, rising expenses, and expresses substantial doubt about the company's ability to continue as a going concern [Overview](index=13&type=section&id=Overview) The company is focused on its sole product, Gimoti, but anticipates needing additional funding to continue operations beyond Q2 2021 - The company's sole product, Gimoti, was approved by the FDA on June 19, 2020, and launched commercially in the U.S. in October 2020[50](index=50&type=chunk) - A partnership with Eversana governs the commercialization of Gimoti and includes a **$5 million revolving credit facility**, of which $2 million was borrowed in June 2020[50](index=50&type=chunk) - As of September 30, 2020, cash and cash equivalents were approximately **$6.3 million**, which is expected to fund operations only into the second quarter of 2021[52](index=52&type=chunk) [Results of Operations](index=16&type=section&id=Results%20of%20Operations) Operating expenses increased significantly year-over-year, driven by a $5 million R&D milestone payment and higher G&A costs for commercialization Comparison of Operating Expenses (Nine Months Ended Sep 30) | Expense Category | 2020 | 2019 | Change | | :--- | :--- | :--- | :--- | | Research and development | $6,450,979 | $2,774,924 | $3,676,055 | | General and administrative | $4,387,284 | $2,955,371 | $1,431,913 | - The **$3.7M increase in nine-month R&D expense** was primarily due to a **$5 million milestone expense** related to the FDA's approval of Gimoti[65](index=65&type=chunk) - For Q3 2020, G&A expenses increased by approximately **$1.1 million YoY** as the company shifted its focus to selling activities, with about $745,000 of the quarterly total related to commercialization[64](index=64&type=chunk) [Liquidity and Capital Resources](index=17&type=section&id=Liquidity%20and%20Capital%20Resources) The company's short cash runway creates substantial doubt about its ability to continue as a going concern, necessitating additional financing - During the nine months ended September 30, 2020, the company raised approximately **$3.3 million net** from its at-the-market (FBR) sales agreement and **$2 million** from the Eversana Credit Facility[68](index=68&type=chunk)[71](index=71&type=chunk) - Management concluded there is **substantial doubt about the company's ability to continue as a going concern**, with existing cash of $6.3 million sufficient to fund operations only into Q2 2021[68](index=68&type=chunk)[70](index=70&type=chunk) - With the approval of the Gimoti NDA, the company is now committed to pay Mallinckrodt a **$5 million milestone payment** by June 2021[75](index=75&type=chunk) [Item 3. Quantitative and Qualitative Disclosures about Market Risk](index=19&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20about%20Market%20Risk) The company reports no material changes in its market risk profile since its 2019 year-end filing - **No material changes** in market risk were reported since the company's 2019 Annual Report on Form 10-K[76](index=76&type=chunk) [Item 4. Controls and Procedures](index=19&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that the company's disclosure controls and procedures were effective as of September 30, 2020 - Management concluded that **disclosure controls and procedures were effective** as of September 30, 2020[77](index=77&type=chunk) - There were **no changes in internal control over financial reporting** during the quarter that materially affected, or are reasonably likely to materially affect, internal controls[78](index=78&type=chunk) PART II. OTHER INFORMATION [Item 1. Legal Proceedings](index=20&type=section&id=Item%201.%20Legal%20Proceedings) The company is not currently a party to any material legal proceedings - The company is **not currently a party to any material legal proceedings**[80](index=80&type=chunk) [Item 1A. Risk Factors](index=20&type=section&id=Item%201A.%20Risk%20Factors) The company's viability is entirely dependent on its sole product, Gimoti, and its ability to secure substantial additional funding - The company's business is **entirely dependent on the success of its only product, Gimoti**; failure to successfully commercialize it could force the company to liquidate[81](index=81&type=chunk) - The company requires **substantial additional funding**, as existing cash is only sufficient to fund operations into Q2 2021, raising going concern issues[82](index=82&type=chunk) - The **COVID-19 pandemic poses significant risks** to commercialization efforts, manufacturing, and the company's ability to raise capital[89](index=89&type=chunk)[91](index=91&type=chunk) - The company is committed to conducting a **post-marketing pharmacokinetics trial for Gimoti**, which could face delays and increased costs[85](index=85&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=26&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) The company reports no unregistered sales of equity securities for the period - **None reported**[94](index=94&type=chunk) [Item 3. Defaults Upon Senior Securities](index=26&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) The company reports no defaults upon senior securities - **None reported**[94](index=94&type=chunk) [Item 4. Mine Safety Disclosure](index=26&type=section&id=Item%204.%20Mine%20Safety%20Disclosure) This item is not applicable to the company - **Not applicable**[94](index=94&type=chunk) [Item 5. Other Information](index=26&type=section&id=Item%205.%20Other%20Information) The company reports no other information for this item - **None reported**[60](index=60&type=chunk) [Item 6. Exhibits](index=27&type=section&id=Item%206.%20Exhibits) This section provides an index of all exhibits filed with the report, including key agreements and required certifications - The report includes an index of filed exhibits, such as the **3PL Agreement with Eversana Life Science Services, Inc.**, CEO/CFO certifications, and XBRL data files[96](index=96&type=chunk)
Evoke Pharma(EVOK) - 2020 Q2 - Quarterly Report
2020-08-06 12:35
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 June 30, 2020 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE EXCHANGE ACT OF 1934 Commission File Number 001-36075 EVOKE PHARMA, INC. (Exact name of registrant as specified in its charter) Delaware 20-8447886 (State or other jurisdiction of incorporation) (IRS Employer Identificatio ...