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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 that a retrospective analysis regarding metoclopramide and the risk of tardive dyskinesia (TD) will be presented at the Digestive Disease Week Meeting in May 2022. This study, utilizing data from an 80 million patient database, aims to clarify TD risks associated with metoclopramide in diabetic gastroparesis patients. GIMOTI, Evoke's key product, is a nasal spray formulation of metoclopramide approved for this indication. The presentation will update healthcare professionals on findings from recent real-world data, potentially impacting treatment approaches.
Evoke Pharma (NASDAQ: EVOK) announced positive outcomes from a recent study on GIMOTI (metoclopramide) nasal spray, highlighting increased awareness and intent to prescribe among healthcare providers. Conducted by EVERSANA, the study revealed that 88% of respondents intend to prescribe GIMOTI, with notable increases in its use as a first and third-line treatment for diabetic gastroparesis. Additionally, GIMOTI has been approved for coverage under New York Medicaid, enhancing patient access. Patient testimonial videos showcasing the benefits of GIMOTI are now available on GimotiRx.com.
Evoke Pharma (NASDAQ: EVOK) and EVERSANA have confirmed the extension of their collaboration agreement for the commercialization of Gimoti® (metoclopramide) nasal spray in the U.S. until December 31, 2026. This partnership, originally established in January 2020, enables Evoke to retain ownership of Gimoti while allowing EVERSANA to manage market access, marketing, and distribution. The updated agreement enhances Evoke's profit retention from Gimoti sales and accelerates cost reimbursements. Gimoti addresses significant needs in diabetic gastroparesis treatment.
Evoke Pharma, a specialty pharmaceutical company focused on gastrointestinal treatments, will participate in the H.C. Wainwright BIOCONNECT Conference from January 10-13, 2022. Management's presentation will be accessible online starting January 10 at 7:00 a.m. ET. Investors interested in one-on-one meetings may contact a representative or Daniel Kontoh-Boateng. Evoke is known for GIMOTI, a nasal spray for diabetic gastroparesis relief, currently the only FDA-approved drug for this condition in the U.S., targeting a significant patient population worldwide.
Evoke Pharma, Inc. (NASDAQ: EVOK) reported a net loss of approximately $2.0 million for Q3 2021, slightly improved from $2.1 million in Q3 2020. Net product sales surged to around $930,000, driven by a notable increase in GIMOTI prescriptions. Research and development expenses decreased to $0.1 million, while selling, general, and administrative (SG&A) expenses rose to $2.6 million due to commercialization efforts. As of September 30, 2021, cash reserves stood at about $11.1 million, projected to support operations until Q3 2022. GIMOTI continues to gain traction among healthcare providers.
Evoke Pharma, focused on gastrointestinal treatments, plans to release its third-quarter 2021 financial results on November 10, 2021, post-market. A conference call will follow at 4:30 p.m. ET to discuss these results. The company has commercialized GIMOTI, a nasal spray for diabetic gastroparesis, the only FDA-approved treatment for this condition. Evoke emphasizes the market potential for GIMOTI amid ongoing challenges, including reliance on third-party manufacturing and market demand dynamics. The company warns of various risks that could impact operations and revenue generation.
Evoke Pharma (NASDAQ: EVOK) announced positive results from a recent market study on its GIMOTI® (metoclopramide) nasal spray. Conducted by EVERSANA, the study revealed that 92% of healthcare practitioners intend to prescribe GIMOTI, up from previous surveys. Key findings highlight a shift in preference for nasal administration over oral, with 45% of gastroenterologists favoring this route. The company will present these insights at the ACG Conference in Las Vegas on October 22-27, 2021.
Evoke Pharma and EVERSANA received the Sales Aid Silver Award for their "Spray Away" campaign promoting GIMOTI, a nasal spray for Diabetic Gastroparesis, at the PM360 Trailblazer Initiative Awards held on September 23, 2021. The campaign highlights GIMOTI's innovative delivery method, aiding patients who struggle with oral medications due to nausea or gastric delay. Since launching GIMOTI in October 2020, Evoke has achieved nearly 9 million media impressions and continues to enhance awareness among healthcare providers and patients.
Evoke Pharma, Inc. (NASDAQ: EVOK) announced its participation in the H.C. Wainwright 23rd Annual Global Investment Conference from September 13-15, 2021. CEO Dave Gonyer and CBO Matt D’Onofrio will engage in a virtual presentation on September 13, which will be available on-demand starting at 7:00 am ET.
This conference will include corporate presentations and one-on-one meetings. Interested investors can schedule calls with Evoke management via their H.C. Wainwright representative.
Evoke Pharma reported a 162% increase in product sales and 152% growth in prescriptions for Gimoti in Q2 2021. The company expanded its base of new prescribers significantly, with a rise from 84 to 132 over the quarter. Net loss decreased to approximately $2.3 million from $7.0 million year-over-year, while net product sales reached $237,000. Total operating expenses were $2.4 million, down from $7.0 million in Q2 2020. As of June 30, 2021, cash equivalents stood at $16.7 million, expected to support operations until Q3 2022.