Core Insights - The FDA has announced that the supply of unapproved domperidone is expected to be exhausted by early 2025, highlighting the urgent need for alternative treatments for gastroparesis [2][4] - GIMOTI, a nasal spray formulation of metoclopramide, is the only FDA-approved treatment for acute and recurrent diabetic gastroparesis, positioning it as a critical option for patients [1][6] - Real-world evidence indicates that GIMOTI significantly reduces emergency room visits by 60% and hospitalizations by 68% compared to oral metoclopramide, demonstrating its clinical effectiveness [4][5] Company Overview - Evoke Pharma, Inc. is a specialty pharmaceutical company focused on developing treatments for gastrointestinal diseases, with GIMOTI being its primary product [5][6] - The company emphasizes its commitment to providing innovative solutions for patients suffering from gastroparesis, particularly as alternative treatments become less accessible [5][6] Market Context - Gastroparesis is a debilitating condition that leads to delayed stomach emptying, causing severe symptoms and complications, which makes effective treatment options essential [3][6] - The discontinuation of domperidone supply underscores the need for safe and effective therapies like GIMOTI, which bypasses the gastrointestinal tract and addresses the core issues of delayed gastric emptying [2][4]

Core Viewpoint - Evoke Pharma has received notices of allowance for two U.S. patent applications, enhancing its intellectual property for GIMOTI® (metoclopramide) nasal spray, which is the only FDA-approved non-oral therapy for diabetic gastroparesis in the U.S. [1][2] Group 1: Patent Applications - The two patent applications, U.S. 17/366,839 and U.S. 17/366,818, focus on "Nasal Formulations of Metoclopramide," providing additional claims for intranasal administration of metoclopramide for treating gastroparesis [2] - These patents are expected to be Orange Book listable and will expire at the end of 2029, further solidifying the company's market position [2] Group 2: Product Efficacy - GIMOTI offers a reliable treatment option by bypassing the gastrointestinal tract, addressing the challenge of effective drug absorption in patients with gastroparesis [3] - The CEO of Evoke Pharma emphasized that GIMOTI is a groundbreaking therapy, with data showing that many patients find relief with this nasal spray compared to oral medications [4] Group 3: Market Context - Diabetic gastroparesis affects millions globally, leading to delayed stomach emptying and serious gastrointestinal symptoms, which can compromise the efficacy of orally administered medications [6] - Prior to GIMOTI's FDA approval, metoclopramide was only available in oral and injectable forms, making GIMOTI the only approved drug in the U.S. for treating gastroparesis [6]

Financial Performance - Gimoti net product sales for the quarter ended September 30, 2024, were approximately $2.7 million, reflecting a $0.1 million increase compared to the previous quarter[64]. - Net product sales for the three months ended September 30, 2024, increased by approximately $1.1 million, a 70% change compared to the same period in 2023, totaling $2,654,186[79]. - For the nine months ended September 30, 2024, net product sales reached $6,941,042, representing a 98% increase compared to $3,504,636 in 2023[80]. - Net product sales increased by approximately $3.4 million for the nine months ended September 30, 2024, compared to the same period in 2023, driven by increased product adoption and a larger pharmacy network[82]. Expenses and Financial Challenges - The company incurred losses since inception, with ongoing operating losses expected until revenues from Gimoti exceed expenses[60]. - Selling, general and administrative expenses for the three months ended September 30, 2024, increased by approximately $692,753, totaling $3,824,142, a 22% change compared to 2023[79]. - Selling, general and administrative expenses increased by approximately $2.0 million for the nine months ended September 30, 2024, with significant costs in wages, marketing, and legal expenses[82]. - Research and development expenses for the three months ended September 30, 2024, were $11,677, compared to no expenses in the same period in 2023[79]. - Research and development expenses decreased by approximately $0.1 million for the nine months ended September 30, 2024, due to reduced ongoing stability testing costs[82]. - The company anticipates needing to raise additional funds to continue operations, as existing cash may not be sufficient beyond 12 months from the report date[60]. - The company anticipates needing to raise additional funds through various financing methods to support ongoing operations and achieve profitability[83]. Cash and Financing - As of September 30, 2024, the company had cash and cash equivalents of approximately $11.3 million, expected to fund operations into the fourth quarter of 2025[60]. - Cash provided by financing activities was $10.8 million for the nine months ended September 30, 2024, primarily from stock sales and warrant exercises[86]. - The company raised approximately $6.2 million from a public offering of common stock units in February 2024[84]. Compliance and Corporate Actions - The company received a notice from Nasdaq regarding non-compliance with the minimum stockholders' equity requirement, with stockholders' equity reported at $3.5 million as of March 31, 2024[61]. - A reverse stock split was executed on August 1, 2024, combining every twelve shares into one to regain compliance with Nasdaq's minimum bid price requirement[62]. - The company entered into a lease amendment extending the office lease term to March 31, 2027, with an initial monthly base rent of approximately $6,500[86]. Product Development and Market Strategy - The company launched commercial sales of Gimoti in October 2020, with modest sales generated to date[60]. - Future product development and commercialization strategies are critical for the company's financial sustainability and growth[58]. - The company is in discussions with the FDA regarding a post-marketing commitment clinical trial for Gimoti to assess dose proportionality for a lower dose strength[74]. - The company expects to incur expenses related to the commercialization of Gimoti, including a post-marketing PK clinical trial[87]. Market Impact and Patient Outcomes - A study indicated that diabetic gastroparesis patients using Gimoti had reduced healthcare costs by approximately $15,000 over six months compared to those using oral metoclopramide[59]. - A study presented at ACG 2024 showed that all-cause emergency department visits decreased by 55% for patients using nasal metoclopramide compared to those using oral metoclopramide[67]. - Approximately 34% of filled prescriptions for Gimoti were covered by Medicare and Medicaid programs for the nine months ended September 30, 2024[66]. - The ASPN platform has improved the proportion of prescriptions covered by insurance payors through enhanced patient communication and electronic automation[65]. - New prescribers increased by 8% during the quarter ended September 30, 2024[65]. Cost of Goods Sold - The cost of goods sold for the three months ended September 30, 2024, increased by approximately $69,116, a 198% change compared to the same period in 2023[79]. - Cost of goods sold rose by approximately $0.1 million for the nine months ended September 30, 2024, primarily due to stability testing completion timing[82].

Core Insights - Evoke Pharma, Inc. is set to present two posters at the American College of Gastroenterology Annual Scientific Meeting, highlighting the use of its product Gimoti® (metoclopramide) nasal spray in treating gastrointestinal diseases [1] - One of the posters, P3339, has received the ACG's Outstanding Research Award and the Presidential Poster Award, indicating its high impact and excellence in research [1] Company Overview - Evoke Pharma is a specialty pharmaceutical company focused on developing treatments for gastrointestinal disorders, particularly diabetic gastroparesis [2] - Gimoti is a nasal spray formulation of metoclopramide, specifically designed for the relief of symptoms associated with acute and recurrent diabetic gastroparesis in adults [2] - Diabetic gastroparesis affects millions globally, causing delayed gastric emptying and serious gastrointestinal symptoms, with Gimoti being the only FDA-approved treatment for this condition in the U.S. [2]

SOLANA BEACH, Calif., Oct. 22, 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 the appointment of Ben Smeal to serve on the Company’s Board of Directors effective October 18, 2024.   This appointment fulfills a condition set as part of the company’s most recent financing by Nantahala Capital Management. Mr. Smeal brings extensiv ...

Nantahala to nominate 2 board seats Portion of the proceeds received from warrants executed at $8.16/share SOLANA BEACH, Calif., Oct. 01, 2024 (GLOBE NEWSWIRE) -- Evoke Pharma, Inc. (NASDAQ: EVOK), a specialty pharmaceutical company focused on developing treatments for gastrointestinal (GI) diseases, with a particular emphasis on GIMOTI® (metoclopramide) nasal spray, announced today that it received approximately $3.0 million in gross proceeds from the amendment and exercise of existing warrants. The approx ...

SOLANA BEACH, Calif., Sept. 19, 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, reaffirms its commitment to improving the lives of patients suffering from diabetic gastroparesis in light of the recent decision by the U.S. Food and Drug Administration (FDA) to not approve Vanda Pharmaceuticals new drug application (NDA) for Tradipitant, an ...

SOLANA BEACH, Calif., Sept. 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 that management will participate in the Gastroenterology and Hepatology Advanced Practice Providers Conference taking place from September 12 – 14, 2024 at the Gaylord National Resort Convention Center in National Harbor, Maryland. "As a meeting spon ...

Collaborating with advocacy groups to amplify gastroparesis awareness for millions of patients worldwide Call for action to improve health and access for patients SOLANA BEACH, Calif., Aug. 08, 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, together with EVERSANA™, a leading provider of global commercial services to the life science indu ...

The reverse stock split was approved by the company's stockholders at its 2024 annual meeting, held on May 22, 2024, to be effected at the Board's discretion with a ratio within the range of not less than 1-for-2 and not more than 1-for-20. As a result of the reverse stock split, every 12 shares of the company's common stock issued and outstanding will be automatically converted into one share of common stock, with no change in the $0.0001 par value per share or authorized number of shares of common stock. ...