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About Evoke Pharma Inc.
Evoke Pharma Inc. (NASDAQ: EVOK), headquartered in Solana Beach, California, is a specialty pharmaceutical company dedicated to the development and commercialization of innovative treatments for gastrointestinal (GI) disorders and diseases. With a primary focus on diabetic gastroparesis, Evoke addresses a critical unmet medical need by offering a novel, non-oral treatment option that improves patient outcomes and enhances quality of life.
Core Product: Gimoti
At the heart of Evoke Pharma's portfolio is Gimoti®, an FDA-approved nasal spray formulation of metoclopramide. Designed specifically for the relief of symptoms associated with acute and recurrent diabetic gastroparesis in adults, Gimoti offers a unique solution for patients who struggle with oral medications due to delayed gastric emptying, a hallmark of gastroparesis. By bypassing the gastrointestinal tract, Gimoti ensures reliable drug absorption, addressing the core defect of the disease and providing a practical alternative to traditional oral and injectable formulations.
Market Position and Competitive Landscape
Diabetic gastroparesis is a debilitating condition affecting millions worldwide, with a disproportionate prevalence among women. Despite its widespread impact, treatment options remain limited. Metoclopramide is the only FDA-approved drug for gastroparesis in the United States, and Gimoti stands out as the sole non-oral formulation available. This positions Evoke Pharma as a key player in the GI treatment landscape, offering a differentiated product that meets the needs of a historically underserved patient population.
Innovative Approach and Strategic Partnerships
Evoke Pharma's commitment to innovation is evident in its development of Gimoti, which leverages intranasal drug delivery to overcome the challenges associated with oral medications in gastroparesis patients. The company has also established strategic partnerships, such as its collaboration with EVERSANA, to support the commercialization and market access of Gimoti. These partnerships enhance Evoke's ability to reach patients, streamline the prescription process, and ensure broad access to its groundbreaking therapy.
Real-World Evidence and Impact
Real-world data underscores the clinical and economic benefits of Gimoti. Studies have demonstrated significant reductions in emergency room visits and hospitalizations among patients treated with Gimoti compared to oral metoclopramide. Additionally, Gimoti has shown a substantial reduction in overall healthcare costs, highlighting its value to both patients and payers. These outcomes reinforce Evoke Pharma's role in improving patient care and reducing the burden on the healthcare system.
Commitment to Patients and Providers
Evoke Pharma is dedicated to addressing the challenges faced by gastroparesis patients and their healthcare providers. The company's patient assistance programs and efforts to expand pharmacy distribution networks reflect its mission to ensure that no patient goes untreated due to economic or access barriers. By prioritizing patient-centric solutions and leveraging strong clinical evidence, Evoke continues to set the standard for innovation in gastroparesis treatment.
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.
Evoke Pharma reaffirms its commitment to patients with diabetic gastroparesis following the FDA's decision not to approve Vanda Pharmaceuticals' Tradipitant. Evoke's product, Gimoti (metoclopramide nasal spray), remains the sole FDA-approved non-oral outpatient treatment for acute and recurrent symptoms of diabetic gastroparesis in adults.
Real-world data presented at Digestive Disease Week 2023 showed that Gimoti users experienced significant reductions in emergency room visits (-60%) and hospitalizations (-68%) compared to oral metoclopramide over six months. A cost analysis revealed that Gimoti reduced total care costs by approximately $15,000 within the first six months compared to oral metoclopramide.
Evoke continues to focus on improving patient outcomes and expanding access to Gimoti, which has been provided to over 4,000 patients since launch. The company is also positioning itself to respond to new challenges, such as gastroparesis linked to GLP-1 receptor agonists.
Evoke Pharma, a specialty pharmaceutical company focusing on gastrointestinal (GI) diseases, announced its participation in the 7th Annual Gastroenterology and Hepatology Advanced Practice Providers (GHAPP) Conference from September 12-14, 2024, in National Harbor, Maryland. As a four-year meeting sponsor, Evoke Pharma aims to engage with nurse practitioners and physician assistants who manage patients with GI disorders, including gastroparesis.
The company will host a booth to discuss GIMOTI® (metoclopramide) nasal spray, their treatment for diabetic gastroparesis. CEO Matt D'Onofrio emphasized the importance of connecting with advanced practice providers and showcasing GIMOTI's positive impact on patients. Demittre Sorenson, PA-C, from the Center for Advanced GI, highlighted GIMOTI's effectiveness in treating gastroparesis patients, noting its nasal delivery bypasses the dysfunctional gut.
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