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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, Inc. (NASDAQ: EVOK) announced significant growth in 2022 with net product sales from prescriptions rising 179% to $2.5 million. Patient enrollments increased by 149%. Despite a slight decline in Q4 sales to $796,000, overall prescription fills surged 178% for the year. The company expanded its prescriber base by 25% to 1,017. Evoke's strategic initiatives include enhanced market access via partnerships and telehealth integration. However, net losses for 2022 stood at $8.2 million or $2.62 per share. As of December 31, 2022, cash reserves were approximately $9.8 million, projected to sustain operations into Q3 2023.
Evoke Pharma, Inc. (NASDAQ: EVOK) announced it will report its fourth quarter and full year 2022 financial results on March 21, 2023, after market close. A conference call will be hosted at 4:30 p.m. ET on the same day to discuss the results. Dial-in numbers are (800) 245-3047 for domestic calls and (203) 518-9765 for international calls, with conference ID EVOKQ422. A telephonic replay of the call will be available until March 28, 2023. Evoke specializes in treatments for gastrointestinal diseases, notably GIMOTI®, a nasal spray for diabetic gastroparesis, a condition affecting millions globally.
Evoke Pharma, Inc. (NASDAQ: EVOK) announced that its abstract on reducing healthcare resource usage for diabetic gastroparesis (DGP) patients, treated with GIMOTI® nasal spray, was selected for a plenary presentation at Digestive Disease Week (DDW) 2023. The event occurs from May 6-9, 2023, at McCormick Place, Chicago, IL. Dr. David C. Kunkel will present data from a study of 514 patients comparing GIMOTI with oral metoclopramide. GIMOTI is a non-oral FDA-approved formulation designed for DGP treatment, addressing unpredictable absorption issues. This presentation will demonstrate GIMOTI's effectiveness and potential impact on patient care.
Evoke Pharma (NASDAQ: EVOK), a specialty pharmaceutical company, announced the filing of a joint stipulation of dismissal in a patent infringement case concerning GIMOTI (metoclopramide) nasal spray. This dismissal follows Teva Pharmaceuticals' shift from a Paragraph IV to a Paragraph III certification, which delays any ANDA approvals until the relevant patents expire. Importantly, this outcome prevents future ANDA filers from qualifying for 180-day exclusivity for GIMOTI. CEO Dave Gonyer emphasized the defense of GIMOTI's intellectual property against larger competitors and the company's commitment to healthcare innovation.
Evoke Pharma has announced a real-world study to be presented at the AMCP annual meeting regarding its nasal spray treatment, GIMOTI (metoclopramide), for diabetic gastroparesis (DGP). The study analyzed healthcare resource utilization among 294 patients before and after starting GIMOTI. It aims to demonstrate whether GIMOTI reduces the necessity for various healthcare visits, including emergency care. GIMOTI is the first FDA-approved nasal formulation for DGP, designed for patients who struggle with oral medication absorption. This presentation is scheduled for March 23, 2023, in San Antonio, TX, highlighting GIMOTI's potential effectiveness in improving patient outcomes.
Evoke Pharma, Inc. (NASDAQ: EVOK) announced the issuance of US patent No. 11,517,545 for its metoclopramide nasal spray, GIMOTI, aimed at treating moderate and severe gastroparesis. The patent, expiring in 2038, enhances Evoke's intellectual property portfolio, validating efficacy observed in Phase 3 trial results. GIMOTI is currently the only FDA-approved drug for this condition, targeting a significant market of diabetic gastroparesis patients. The company is focused on ensuring long-term availability of GIMOTI to improve patient care.
Evoke Pharma, Inc. (NASDAQ: EVOK), announced that the USPTO issued a Notice of Allowance for its patent application No. 17/100,664 concerning GIMOTI (metoclopramide) nasal spray. This patent is crucial as it will protect GIMOTI's market position until December 2029. As the first FDA-approved nasal formulation for treating diabetic gastroparesis, GIMOTI offers a vital alternative for patients with oral absorption issues. The company expressed optimism regarding the patent's approval, emphasizing the importance of securing GIMOTI's availability for healthcare providers and patients.
Evoke Pharma reported a significant increase in third-quarter financial performance for 2022, with GIMOTI net sales rising 80% to $832,000 compared to Q2 2022. Prescription fills for GIMOTI also saw a 56% increase, along with a 13% growth in new prescribers, totaling 143. The company transitioned its reimbursement program to vitaCare, leading to a 32% increase in inbound prescriptions. The company’s net loss decreased slightly to $2.0 million or $0.60 per share. With cash reserves of $12.4 million, Evoke anticipates sufficient funds to operate into Q2 2023.
Evoke Pharma (NASDAQ: EVOK) is set to release its third-quarter financial results on November 9, 2022, after market closure. A conference call will follow at 4:30 p.m. ET for detailed discussion of the results. Evoke Pharma specializes in gastrointestinal treatments, notably GIMOTI, a nasal spray for diabetic gastroparesis. This product is currently the only FDA-approved treatment for this condition in the United States, targeting a significant market opportunity.
Evoke Pharma (NASDAQ: EVOK) will exhibit its flagship product, Gimoti, at the 2022 American College of Gastroenterology Annual Scientific Meeting from October 21-26, 2022, in Charlotte, North Carolina. The company is also nominated for the Healio Industry Breakthrough Product Award and will participate in the Disruptive Innovators Awards Program on October 23. Gimoti is designed for adults with acute and recurrent diabetic gastroparesis, a condition impairing gastric emptying. The company aims to improve discussions with GI professionals during the meeting.
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