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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) announced its participation in the H.C. Wainwright 26th Annual Global Investment Conference from September 9-11, 2024, in New York City. The company, specializing in gastrointestinal disease treatments, will present on its flagship product GIMOTI® (metoclopramide nasal spray) for diabetic gastroparesis.
Key points:
- Presentation available on-demand to registered attendees from September 9, 2024, at 7:00 a.m. ET
- Archived webcast accessible on Evoke Pharma's investor relations website
- Management to participate in one-on-one meetings with investors
- Focus on recent positive commercial progress of GIMOTI®
This conference provides Evoke Pharma an opportunity to showcase its advancements in GI treatments and engage with potential investors.
Evoke Pharma (NASDAQ: EVOK) reported strong Q2 2024 financial results for GIMOTI, its nasal spray treatment for diabetic gastroparesis. Net product sales grew 47% quarter-over-quarter and 126% year-over-year, indicating an annual run-rate exceeding $10 million. The company achieved record-high prescription fills, with a 75% year-over-year increase and 32% growth compared to Q1 2024. Net loss narrowed to $1.3 million ($0.93 per share) from $1.9 million ($6.70 per share) in Q2 2023. Evoke revised its 2024 guidance to $11-12 million, still reflecting over 100% growth from the previous year. The company believes its current cash position and future GIMOTI sales will fund operations into Q2 2025.
Evoke Pharma (NASDAQ: EVOK) is supporting Gastroparesis Awareness Month in August, collaborating with advocacy groups to raise awareness for millions of patients worldwide. Gastroparesis, affecting approximately 2% of the U.S. population, is a disorder where food moves slower than normal from the stomach to the intestines. Evoke's CEO, Matt D'Onofrio, emphasizes the company's dedication to ensuring diabetic gastroparesis patients receive treatment through their assistance programs.
Evoke's product, GIMOTI® (metoclopramide) nasal spray, launched in June 2020, is the only non-oral FDA-approved outpatient gastroparesis treatment in over 30 years. Over 4,000 patients have received GIMOTI, which has shown significant impact on reducing healthcare facility use and saving patients and insurers over $15,000 in expenses over a six-month period compared to oral metoclopramide.
Evoke Pharma (NASDAQ: EVOK) has announced a 1-for-12 reverse stock split of its common stock, effective August 1, 2024. This decision, approved by stockholders on May 22, 2024, aims to bring the company into compliance with Nasdaq's minimum bid price requirement. The stock will continue trading under the symbol EVOK with a new CUSIP number. Every 12 shares will be converted into one share, with no change in par value or authorized shares. Fractional shares will be paid in cash. The split will affect all outstanding stock options, warrants, and equity incentive plans proportionately. Equiniti Trust Company will act as the exchange agent for the process.
Evoke Pharma reports significant progress in its commercial strategy and positive momentum for its GI treatment product, GIMOTI. The company achieved its highest monthly GIMOTI prescription fills in May 2024 and expanded state Medicaid access. Evoke transitioned its pharmacy distribution to ASPN Pharmacies in November 2023, improving prescription conversion rates. Through Eversana, Evoke also broadened its pharmacy network to include four additional regional pharmacies, improving access in states like Arkansas and Illinois.
Leadership changes include the promotion of Mark Kowieski to Chief Financial Officer. The company focuses on enhancing operational efficiency and plans to continue its growth trajectory throughout 2024.
Evoke Pharma (NASDAQ: EVOK) will present data on GIMOTI®, a nasal spray for gastroparesis, at the 2024 Digestive Disease Week Conference (DDW 2024) in Washington D.C. from May 18-21, 2024. The study focuses on the benefits of GIMOTI for women, who are most affected by gastroparesis. The data demonstrates fewer physician visits, hospitalizations, and emergency department visits compared to oral metoclopramide. The presentation, led by Dr. David C. Kunkel from the University of San Diego Health, is scheduled for May 20, 2024. Evoke Pharma will also have a commercial booth (#737) at the conference.
Evoke Pharma reported a strong first quarter for 2024, with net product sales increasing by 114% year-over-year to $1.7 million. The company saw a 70% growth in prescriber numbers compared to Q4 2023 and reaffirmed its $14 million net revenue guidance for 2024. Challenges included a cyberattack and increased co-pay expenses, but the company remains optimistic, leveraging its partnership with ASPN Pharmacies. The first quarter also saw the company raising $8.8 million through a public offering. Net loss was reduced to $1.6 million from $2.2 million in Q1 2023. Cash position stands at $9.7 million, expected to fund operations into Q1 2025.
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