Evoke Pharma Reports Commercial Strategy Progress & Positive Momentum for GIMOTI

Expanded State Medicaid Access for GIMOTI

Achieved highest ever monthly GIMOTI prescription fills in May 2024

Promoted former VP of Finance, Mark Kowieski to Chief Financial Officer

SOLANA BEACH, Calif., June 17, 2024 (GLOBE NEWSWIRE) -- Evoke Pharma, Inc. (NASDAQ: EVOK), a specialty pharmaceutical company focused primarily on treatments for gastrointestinal (GI) diseases with an emphasis on GIMOTI^® (metoclopramide) nasal spray, announced updates regarding their business and commercial growth strategy. With a determined focus to ensure maximum market access for GIMOTI, Evoke continues to execute on its plan to expand net product sales throughout 2024. This update outlines the key areas of Evoke’s strategic blueprint and positive updates regarding its implementation.

ASPN Pharmacy Platform

In November 2023, Evoke transitioned its pharmacy distribution partnership from vitaCare to ASPN Pharmacies. This strategic move has streamlined the prescription process for healthcare providers, ensuring that patients receive GIMOTI promptly. Over two quarters of collaboration with ASPN, Evoke has improved percentages of GIMOTI prescriptions converted to fills, and initial data show record-high prescription fills in April and May. ASPN's comprehensive servicing platform provides holistic advantages for our business, healthcare providers, and patients, reinforcing Evoke’s mission to reach as many patients as possible.

“We continue to make inroads into the diabetic gastroparesis market and believe we are well positioned to improve the health and daily life of patients suffering with symptoms of this debilitating disease. We have invested significantly in generating evidence to demonstrate the value of GIMOTI to patients, providers and payers. Partnering with ASPN affords Evoke access to state of the art tools and capabilities and allows us to ensure we can deliver GIMOTI quickly, improve patient and provider experience and ramp up for future demand,” said Chris Quesenberry, Chief Commercial Officer for GIMOTI.

Medicaid access through Pharmacy Partnerships

In May 2024, Evoke, through Eversana, began expanding our filling pharmacy network from a single central organization to an additional four regional pharmacies. This is intended to allow for improved coverage, reimbursement and speed to deliver GIMOTI to patients in need. Some of the states where access to GIMOTI will improve based on expanded distribution include: Arkansas, Connecticut, Georgia, Illinois, and Michigan, Mississippi, Rhode Island and Tennessee. In our first full month with these additional pharmacies, Evoke is already realizing additional GIMOTI covered prescriptions through insurers, especially Medicaid patients. Evoke anticipates further expansion of our pharmacy distribution in the coming months.

“Halfway into 2024, as prescriptions continue to grow, we are executing on our distribution expansion strategy and are seeing improved growth trajectory of access and sales for GIMOTI. The combination of the shift to ASPN and the expansion of additional regional pharmacies is yielding results to help unlock GIMOTI's true market potential,” stated Matt D’Onofrio, Chief Executive Officer of Evoke Pharma.

Leadership Changes and Operational Enhancements

In alignment with Evoke’s growth objectives, we are pleased to announce the promotion of Mark Kowieski, formerly our VP of Finance, to the role of Chief Financial Officer in May 2024. Mark brings a wealth of financial and public accounting experience and a deep understanding of Evoke Pharma’s operations to the role, which are instrumental in enhancing our operational efficiency and driving excellence.

Evoke is committed to maintaining a lean business model to maximize value for our stakeholders. Mark’s promotion is a key part of our plan to streamline operations and reduce overhead costs while accelerating growth.

Mark Kowieski, newly appointed Chief Financial Officer of Evoke Pharma, commented, “I am thrilled to assume the role of CFO at Evoke Pharma during this pivotal time in our company’s commercial journey. With the robust support from Eversana and the expertise of our leadership team and board, I am confident that we have all the necessary tools to drive significant business growth. Our focus remains on accelerating revenue growth, ensuring GIMOTI is accessible to all patients in need, and ultimately generating substantial value for our shareholders.”

The company will report full results for sales in the second quarter in August 2024.

About Gimoti^® (metoclopramide) nasal spray

GIMOTI is indicated for the relief of symptoms in adults with acute and recurrent diabetic gastroparesis. Important Safety Information

WARNING: TARDIVE DYSKINESIA

• Metoclopramide can cause tardive dyskinesia (TD), a serious movement disorder that is often irreversible. The risk of developing TD increases with duration of treatment and total cumulative dosage.
• Discontinue GIMOTI in patients who develop signs or symptoms of TD. In some patients, symptoms may lessen or resolve after metoclopramide is stopped.
• Avoid treatment with metoclopramide (all dosage forms and routes of administration) for longer than 12 weeks because of the increased risk of developing TD with longer-term use.
  

GIMOTI is not recommended for use in:

• Pediatric patients due to the risk of developing tardive dyskinesia (TD) and other extrapyramidal symptoms as well as the risk of methemoglobinemia in neonates.
• Moderate or severe hepatic impairment (Child-Pugh B or C), moderate or severe renal impairment (creatinine clearance less than 60 mL/minute), and patients concurrently using strong CYP2D6 inhibitors due to the risk of increased drug exposure and adverse reactions.

GIMOTI is contraindicated:

• In patients with a history of tardive dyskinesia (TD) or a dystonic reaction to metoclopramide.
• When stimulation of gastrointestinal motility might be dangerous (e.g., in the presence of gastrointestinal hemorrhage mechanical obstruction, or perforation).
• In patients with pheochromocytoma or other catecholamine-releasing paragangliomas. Metoclopramide may cause a hypertensive/pheochromocytoma crisis, probably due to release of catecholamines from the tumor.
• In patients with epilepsy. Metoclopramide may increase the frequency and severity of seizures.
• In patients with hypersensitivity to metoclopramide. Reactions have included laryngeal and glossal angioedema and bronchospasm.
  

Potential adverse reactions associated with metoclopramide include: Tardive dyskinesia (TD), other extrapyramidal effects (EPS), parkinsonism symptoms, motor restlessness, neuroleptic malignant syndrome (NMS), depression, suicidal ideation and suicide, hypertension, fluid retention, hyperprolactinemia, effects on the ability to drive and operate machinery. Most common adverse reactions (≥5%) for GIMOTI are: dysgeusia, headache, and fatigue. These are not all of the possible side effects of GIMOTI. Call your doctor for medical advice about whether you should take GIMOTI and the possible risk factors and side effects. You are encouraged to report negative side effects of prescription drugs to the FDA.

Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

About Evoke Pharma, Inc.

Evoke is a specialty pharmaceutical company focused primarily on the development of drugs to treat GI disorders and diseases. The company developed, commercialized and markets GIMOTI, a nasal spray formulation of metoclopramide, for the relief of symptoms associated with acute and recurrent diabetic gastroparesis in adults.

Diabetic gastroparesis is a GI disorder affecting millions of patients worldwide, in which the stomach takes too long to empty its contents resulting in serious GI symptoms as well as other systemic complications. The gastric delay caused by gastroparesis can compromise absorption of orally administered medications. Prior to FDA approval to commercially market GIMOTI, metoclopramide was only available in oral and injectable formulations and remains the only drug currently approved in the United States to treat gastroparesis.

About EVERSANA

EVERSANA™ is the leading independent provider of global services to the life sciences industry. The company’s integrated solutions are rooted in the patient experience and span all stages of the product life cycle to deliver long-term, sustainable value for patients, prescribers, channel partners and payers. The company serves more than 500 organizations, including innovative start-ups and established pharmaceutical companies, to advance life sciences solutions for a healthier world. To learn more about EVERSANA, visit eversana.com or connect through LinkedIn and Twitter.

Safe Harbor Statement

Evoke cautions you that statements included in this press release that are not a description of historical facts are forward-looking statements. In some cases, you can identify forward-looking statements by terms such as “may,” “will,” “should,” “expect,” “plan,” “anticipate,” “could,” “intend,” “target,” “project,” “contemplates,” “believes,” “estimates,” “predicts,” “potential” or “continue” or the negatives of these terms or other similar expressions. These statements are based on the company’s current beliefs and expectations. These forward-looking statements include statements regarding: Evoke’s strategy of adding pharmacies to its prescribing platform to drive additional sales; Evoke’s commercialization plans, including the initial data showing that the prescription fills in April and May 2024 are record-highs for the company; and that Evoke is successfully executing on its commercial strategy and may generate stockholder value. The inclusion of forward-looking statements should not be regarded as a representation by Evoke that any of its plans will be achieved. Actual results may differ from those set forth in this press release due to the risks and uncertainties inherent in Evoke’s business, including, without limitation: Evoke may not be able to achieve increased revenues for 2024; Evoke’s and EVERSANA’s ability to successfully drive market demand for GIMOTI; Evoke may not be able to regain compliance with Nasdaq’s minimum bid price requirement or maintain compliance with Nasdaq’s minimum stockholders’ equity requirements which may result in the Evoke’s common stock being delisted from Nasdaq; Evoke’s ability to obtain additional financing as needed to support its operations; Evoke may use its capital resources sooner than expected; warrant holders may choose not to exercise any of the outstanding warrants; Evoke’s dependence on third parties for the manufacture of GIMOTI; Evoke is entirely dependent on the success of GIMOTI; inadequate efficacy or unexpected adverse side effects relating to GIMOTI that could result in recalls or product liability claims; Evoke’s ability to maintain intellectual property protection for GIMOTI; and other risks and uncertainties detailed in Evoke’s prior press releases and in the periodic reports it files with the Securities and Exchange Commission. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and Evoke undertakes no obligation to revise or update this press release to reflect events or circumstances after the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement. This caution is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.

Investor & Media Contact:
Daniel Kontoh-Boateng
DKB Partners
Tel: 862-213-1398
dboateng@dkbpartners.net

Source: Evoke Pharma, Inc.