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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 on September 20, 2022, that the USPTO has issued a Notice of Allowance for patent application No. 16/469,092, covering methods to treat moderate-to-severe gastroparesis with its GIMOTI nasal spray. This patent will contribute to existing FDA-listed patents and will expire in 2037. GIMOTI is the first FDA-approved nasal formulation of metoclopramide for diabetic gastroparesis, enabling effective non-oral medication administration. The Chief Business Officer emphasized the patent's role in protecting clinical trial outcomes and enhancing market presence.
Evoke Pharma, a specialty pharmaceutical company, has announced that its product GIMOTI has been nominated for the Healio Disruptive Innovators Award in the Industry Breakthrough category. GIMOTI is the first FDA-approved nasal spray formulation of metoclopramide for treating acute and recurrent diabetic gastroparesis, which affects drug absorption due to vomiting. Evoke's CEO expressed pride in this recognition as it aligns with their mission to improve treatment options for patients suffering from this condition. Voting for the award is encouraged.
Evoke Pharma announced that its President and CEO, David A. Gonyer, and Chief Business Officer, Matt D’Onofrio, will present at the 24th Annual Global Investment Conference hosted by H.C. Wainwright from September 12-14, 2022, at the Lotte New York Palace Hotel. The presentation is scheduled for September 12, 2022, from 8:30 to 9:00 AM ET, and will be available for on-demand streaming for 30 days post-conference. Evoke is known for developing GIMOTI, a nasal spray for diabetic gastroparesis, the only FDA-approved medication for this condition.
Evoke Pharma has partnered with EVERSANA and UpScriptHealth to launch a new telehealth service for patients suffering from diabetic gastroparesis. This service will facilitate access to care for patients with limited healthcare access, allowing for same-day appointments with licensed providers. A recent survey indicated that over half of gastroparesis patients report severe symptoms, and 60% are unsatisfied with existing treatments. The initiative aims to provide better access to GIMOTI, Evoke's nasal spray formulation for diabetic gastroparesis.
Evoke Pharma, Inc. (NASDAQ: EVOK) reported strong Q2 2022 results, highlighting a 24% increase in new inbound prescriptions and an 11% rise in net revenue, totaling approximately $462,000. The cumulative number of new GIMOTI prescribers grew by 23% compared to Q1 2022. Medicaid approvals in Texas and Florida expand market access to 10 million lives. The company raised approximately $7.1 million to extend its cash runway into Q2 2023. However, the net loss was approximately $2.2 million, or $0.71 per share.
Evoke Pharma (NASDAQ: EVOK) plans to release its second quarter results on August 10, 2022, after market close. A conference call is scheduled for the same day at 4:30 p.m. ET, where management will discuss the results. Domestic callers can dial (800) 343-4849, while international callers should use (203) 518-9848. GIMOTI, Evoke's nasal spray for diabetic gastroparesis, remains the only FDA-approved treatment in the U.S. for this condition, which affects millions globally.
Evoke Pharma (NASDAQ: EVOK) collaborates with IFFGD for August's Gastroparesis Awareness Month, aiming to enhance understanding of the condition that affects up to five million Americans. Participating in a virtual wellness event, Evoke and EVERSANA achieved first place with 3.1 million steps taken, supporting gastrointestinal research. The company promotes resources like DGP-n-Me for patient education. Data from IFFGD shows 52% of gastroparesis patients report severe symptoms, with many dissatisfied with current treatments. Evoke also plans to attend the ANMS 2022 meeting to discuss diabetic gastroparesis management.
Evoke Pharma, Inc. (NASDAQ: EVOK) has received a key patent from the Canadian Intellectual Property Office for its nasal spray formulation of metoclopramide, GIMOTI®, aimed at treating diabetic gastroparesis. This patent, expiring in 2029, enhances Evoke's intellectual property portfolio, complementing other U.S. patents that expire in 2029 and 2030. Following prior FDA exclusivity granted in April 2022, Evoke holds exclusive rights to market GIMOTI® for three years against generics, positioning the product as a significant treatment solution for this GI disorder.
Evoke Pharma (NASDAQ: EVOK) announced that Florida's Medicaid Pharmaceutical & Therapeutics Committee has approved the inclusion of GIMOTI, its nasal spray for treating diabetic gastroparesis, in the state's Preferred Drug List, effective immediately. This decision enhances patient access to GIMOTI, particularly for adults unable to use oral metoclopramide due to delayed gastric emptying. With approximately 5 million beneficiaries in Florida's Medicaid, this approval marks a significant milestone for Evoke in expanding GIMOTI's market presence and improving treatment options for patients suffering from this GI disorder.
Evoke Pharma (NASDAQ: EVOK) announced it has regained compliance with Nasdaq's minimum bid price requirement, closing the matter previously raised on December 29, 2021. The company's stock was under the $1.00 threshold but achieved compliance by maintaining a minimum closing bid price of $1.00 for 10 consecutive days post a 1-for-12 reverse stock split. In May, Evoke raised approximately $7.1 million through its at-the-market program, extending its cash runway into the second quarter of 2023. The company aims to leverage this funding to boost GIMOTI sales.
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