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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) plans to release its first quarter 2021 financial results on May 12, 2021, after market close. A conference call is scheduled for the same day at 4:30 p.m. ET, with dial-in numbers provided for domestic and international callers. Evoke focuses on gastrointestinal (GI) disorders, specifically with its product GIMOTI, a nasal spray for diabetic gastroparesis. This condition affects millions by delaying gastric emptying, impacting medication absorption. GIMOTI is currently the only FDA-approved treatment for this disorder.
Evoke Pharma announced a significant achievement with the U.S. Patent and Trademark Office granting a Notice of Allowance for its nasal spray Gimoti (metoclopramide), aimed at treating gastroparesis. The patent, covering the method of use for this innovative delivery system, extends protection until at least 2029. Gimoti, which received FDA approval in June 2020, offers a critical option for diabetic patients struggling with oral medication absorption. This development enhances Evoke's intellectual property portfolio and marketing strategy.
Evoke Pharma, Inc. (Nasdaq: EVOK) announced a fireside chat scheduled for April 1, 2021, at 1:00 PM ET, hosted by Yale Jen, Senior Biotech Analyst at Laidlaw & Company. The event will feature discussions with Dr. Kostas Sideridis and Dr. Richard McCallum, focusing on GIMOTI, Evoke's nasal spray for treating diabetic gastroparesis. This is a significant advancement as GIMOTI is the first FDA-approved treatment specifically for this GI disorder. Investors can submit questions for the panel prior to the event via email.
Evoke Pharma, Inc. (NASDAQ: EVOK) announced its fourth quarter 2020 financial results, reporting net sales of approximately $23,000 and a net loss of about $2.3 million, or $0.09 per share. For the full year, the net loss was about $13.2 million, compared to $7.1 million in 2019. The company launched GIMOTI™, a treatment for diabetic gastroparesis, with early traction noted in sales. A $14.4 million capital raise is expected to extend cash runway into the first quarter of 2022. Despite challenges from the pandemic, positive feedback from gastroenterologists has been reported.
Evoke Pharma, Inc. (Nasdaq: EVOK) has announced plans to release its fourth quarter and full year 2020 financial results on March 11, 2021, after market close. The company will hold a conference call at 4:30 p.m. ET to discuss these results. Evoke is focused on developing treatments for gastrointestinal disorders, notably GIMOTI, a nasal spray for diabetic gastroparesis. This condition affects millions and can delay gastric emptying, leading to significant GI symptoms. The company emphasizes that some statements are forward-looking and subject to risks.
Evoke Pharma, Inc. (Nasdaq: EVOK) has completed a follow-on offering of 5,750,000 shares at $2.50 per share, generating approximately $14.4 million in gross proceeds. The funds will be allocated for working capital, commercialization, research and development, clinical trials, and potential acquisitions. Laidlaw & Company (UK) Ltd. managed the offering under a previously filed shelf registration. This financing aims to enhance Evoke's capacity to treat gastrointestinal disorders, focusing on GIMOTI, a nasal spray for diabetic gastroparesis patients.
Evoke Pharma, Inc. (Nasdaq: EVOK) has priced an underwritten public offering of 5,000,000 shares at $2.50 per share, aiming for gross proceeds of $12.5 million. The offering includes a 45-day option for the underwriter to purchase an additional 750,000 shares. Expected to close around January 19, 2021, the funds will support working capital, commercialization, R&D activities, and potential technology acquisitions. Laidlaw & Company (UK) Ltd. is the sole book-running manager for the offering.
Evoke Pharma, Inc. (Nasdaq: EVOK) announced plans for a public offering of common stock with an underwriter option for an additional 15%. The shares are to be sold entirely by Evoke and will be subject to market conditions. Proceeds will fund working capital, commercialization, R&D activities, and potential technology acquisitions. The offering follows a previously filed shelf registration statement with the SEC. Laidlaw & Company is the sole book-running manager. This press release is not an offer to sell securities in jurisdictions where it would be unlawful.
Evoke Pharma reported promising results from a recent survey on GIMOTI, its newly launched treatment for diabetic gastroparesis. The survey, conducted in December 2020, involved 104 healthcare practitioners and indicated strong intent to prescribe GIMOTI, with 79% of targeted gastroenterologists and 89% of non-target gastroenterologists expressing positive prescribing trends. Notably, GIMOTI's unique nasal delivery method stands out as an alternative to oral treatments, addressing significant patient needs. The company's leadership expressed optimism over the results, paving the way for enhanced commercial efforts in 2021.
Evoke Pharma, focused on treatments for gastrointestinal diseases, reported its Q3 2020 financial results, highlighting the commercial launch of GIMOTI, a nasal treatment for diabetic gastroparesis, in partnership with EVERSANA.
The net loss was approximately $2.1 million, or $0.08 per share, compared to a loss of $1.6 million, or $0.07 per share, in Q3 2019. Operating expenses rose to $2.1 million driven by commercialization efforts. As of September 30, 2020, cash and equivalents stood at $6.3 million, expected to fund operations into Q2 2021, excluding potential GIMOTI revenue.
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