Evoke Pharma Inc - EVOK STOCK NEWS

Evoke Pharma (NASDAQ: EVOK), a specialty pharmaceutical company focused on gastrointestinal diseases and maker of Gimoti® nasal spray, has scheduled its fourth quarter and full year 2024 financial results release for Thursday, March 13, 2025, after market close.

Management will host a conference call and webcast with slides at 4:30 p.m. ET on the same day. Investors can join via phone using domestic dial-in (800) 267-6316 or international (203) 518-9783, with conference ID EVOKQ424. A replay will be available until March 20, 2025, accessible at (800) 723-0544 for domestic and (402) 220-2656 for international callers.

Evoke Pharma (NASDAQ: EVOK) has appointed Greg Pyszczymuka to its Board of Directors, effective February 20, 2025. This is the second board member appointment by Nantahala Capital Management, showing their continued confidence in Evoke's strategy. Pyszczymuka, currently Chief Commercial Officer at Aytu BioPharma, brings extensive experience in pharmaceutical sales and market access.

Under his leadership at Aytu, the company achieved operational profitability and sustainable revenue growth. His 20-year career includes senior roles at Neos Therapeutics, Aqua Pharmaceuticals, Iroko Pharmaceuticals, Zogenix, and Endo Pharmaceuticals. The appointment aims to strengthen Evoke's market presence and enhance shareholder value, particularly in expanding access to GIMOTI®, their metoclopramide nasal spray for gastrointestinal diseases.

Evoke Pharma (NASDAQ: EVOK) highlights GIMOTI's position as the only FDA-approved nasal spray for diabetic gastroparesis as domperidone supply is expected to end in early 2025. The FDA announced that efforts to find alternative domperidone sources have failed, emphasizing the need for approved therapies like GIMOTI.

Real-world data shows GIMOTI's effectiveness with a 60% reduction in emergency room visits and 68% decrease in hospitalizations compared to oral metoclopramide. Notably, 61% of GIMOTI patients were previously on oral metoclopramide, indicating improved benefits after switching to nasal delivery.

Domperidone, while used internationally, was never FDA-approved in the US due to safety concerns, particularly cardiac risks. GIMOTI's nasal delivery system bypasses GI tract issues, addressing delayed emptying in gastroparesis patients who struggle with oral medications.

Evoke Pharma (NASDAQ: EVOK) has received notices of allowance for two U.S. patent applications protecting GIMOTI® nasal spray. The patents, titled 'Nasal Formulations of Metoclopramide,' protect the intranasal administration of metoclopramide for treating gastroparesis. These Orange Book listable patents will expire in 2029. GIMOTI is the only FDA-approved, non-oral, patient-administered therapy for acute and recurrent diabetic gastroparesis in the US. The nasal spray bypasses the GI tract, offering an effective solution for patients who struggle with oral medications due to delayed stomach emptying.

Evoke Pharma reported strong Q3 2024 results with record-breaking GIMOTI net product sales of $2.7 million, marking a 70% year-over-year increase. The company saw significant growth with a 45% increase in prescribers and 52% rise in prescription fills year-over-year. Real-world data presented at ACG 2024 showed GIMOTI's effectiveness for patients on GLP-1 therapy. The company revised its 2024 guidance to $9.5-10.0 million from $11-12 million. As of September 30, cash and equivalents stood at $11.3 million, with an additional $3.5 million raised in October through warrant exercises, extending operations into Q4 2025.

Evoke Pharma announced significant improvements in patient outcomes for GLP-1 users with diabetic gastroparesis using GIMOTI nasal spray compared to oral metoclopramide. A real-world study of 92 patients showed GIMOTI users experienced 91% fewer emergency department visits, 41% fewer office visits, and 89% fewer hospital outpatient visits within a 6-month period. The study, presented at ACG 2024, received both the Presidential Poster Award and Outstanding Research Award in the Stomach Category. The research demonstrates GIMOTI's potential as supportive care for GLP-1 therapy, with no serious adverse events reported in a separate safety analysis.

Evoke Pharma (NASDAQ: EVOK) announced two upcoming poster presentations featuring Gimoti® nasal spray at the American College of Gastroenterology Annual Scientific Meeting in Philadelphia, October 25-29, 2024. One abstract, Poster P3339, received the ACG's Outstanding Research Award in the Stomach Category and the Presidential Poster Award, an honor given to less than 5% of submitted abstracts. The company will also showcase a new marketing campaign and expanded exhibit booth for GIMOTI at location #361.

Evoke Pharma (NASDAQ: EVOK) has appointed Ben Smeal to its Board of Directors, effective October 18, 2024. This appointment fulfills a condition set by Nantahala Capital Management as part of Evoke's recent financing. Smeal brings extensive experience in investment management and corporate governance.

Smeal's background includes roles at Willett Advisors, Kenmare Management, and as Marketing Director at Overstock.com. He holds a B.A. from Williams College and an M.B.A. from Columbia University. CEO Matt D'Onofrio welcomed Smeal, highlighting his experience in public equities and corporate leadership as valuable assets for expanding access to GIMOTI, Evoke's metoclopramide nasal spray for gastrointestinal diseases.

Evoke Pharma (NASDAQ: EVOK) has announced receiving approximately $3.0 million in gross proceeds from the amendment and exercise of existing warrants. The funds will be used to support working capital, general corporate purposes, and advancing commercial efforts for GIMOTI® (metoclopramide) nasal spray. The warrants were exercised at $8.16 per share, with no new warrants issued in these transactions, which closed on September 30, 2024.

CEO Matt D'Onofrio highlighted that recent regulatory events suggest Gimoti is unlikely to face direct branded competition for several years. As part of the transaction, Nantahala Capital Management, an existing investor and warrant holder, has been granted the right to nominate two members to the company's Board of Directors.