EVOK Evoke Pharma Inc.

2.71
0  0%
Previous Close 2.71
Open 2.67
52 Week Low 0.79
52 Week High 6.0628
Market Cap $85,067,567
Shares 31,390,246
Float 30,416,450
Enterprise Value $85,007,925
Volume 281,777
Av. Daily Volume 386,233
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Drug Pipeline

Drug Stage Notes
Gimoti - EVK-001
Diabetic gastroparesis
Approved
Approved
FDA Approval announced June 19, 2020.

Latest News

  1. SOLANA BEACH, Calif., Jan. 20, 2021 (GLOBE NEWSWIRE) -- Evoke Pharma, Inc. (NASDAQ:EVOK), a specialty pharmaceutical company focused on treatments for gastrointestinal (GI) disorders and diseases, announced today the completion of its follow-on offering of 5,750,000 shares of its common stock, including 750,000 shares of common stock sold pursuant to the underwriter's full exercise of its option to purchase additional shares, at a price to the public of $2.50 per share. The gross proceeds from the offering were approximately $14.4 million, before underwriting discounts and commissions and estimated offering costs.

    Evoke intends to use the net proceeds from the offering for working capital and general corporate purposes, including funding…

    SOLANA BEACH, Calif., Jan. 20, 2021 (GLOBE NEWSWIRE) -- Evoke Pharma, Inc. (NASDAQ:EVOK), a specialty pharmaceutical company focused on treatments for gastrointestinal (GI) disorders and diseases, announced today the completion of its follow-on offering of 5,750,000 shares of its common stock, including 750,000 shares of common stock sold pursuant to the underwriter's full exercise of its option to purchase additional shares, at a price to the public of $2.50 per share. The gross proceeds from the offering were approximately $14.4 million, before underwriting discounts and commissions and estimated offering costs.

    Evoke intends to use the net proceeds from the offering for working capital and general corporate purposes, including funding commercialization activities, research and development activities, clinical trial expenditures, and possible acquisition of new technologies or products.

    Laidlaw & Company (UK) Ltd. acted as sole book-running manager for the offering.

    The offering is being conducted pursuant to a shelf registration statement (File No. 333-251614) previously filed and declared effective by the Securities and Exchange Commission (SEC). A final prospectus supplement and accompanying prospectus relating to this offering were filed with the SEC and are available free of charge on the website of the SEC at www.sec.gov. Copies of the final prospectus supplement and the accompanying prospectus relating to this offering may also be obtained from Laidlaw & Company (UK) Ltd, Attention: Syndicate Department, 521 Fifth Avenue, New York, NY 10175, by telephone at (212) 953-4917 or by email at .

    This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of, these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or jurisdiction.

    About Evoke Pharma, Inc.

    Evoke is a specialty pharmaceutical company focused primarily on the commercialization and development of drugs to treat GI disorders and diseases. The Company developed 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.

    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 Evoke's current beliefs and expectations.   These forward-looking statements include statements regarding Evoke's anticipated use of proceeds from the offering.   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 those described in Evoke's periodic filings with the SEC and the prospectus supplement and related prospectus for this offering filed with the SEC. 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 Contact:

    The Ruth Group

    James Salierno

    Tel: 973-255-8361

    Media Contact:

    The Ruth Group

    Annika Parrish

    Tel: 720-412-9042

     



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  2. SOLANA BEACH, Calif., Jan. 13, 2021 (GLOBE NEWSWIRE) -- Evoke Pharma, Inc. (NASDAQ:EVOK), a specialty pharmaceutical company focused on treatments for gastrointestinal (GI) disorders and diseases, today announced that it has priced an underwritten public offering of 5,000,000 shares of its common stock at a price to the public of $2.50 per share. Gross proceeds, before underwriting discounts and commissions and estimated offering costs, are expected to be $12.5 million. Evoke has granted the underwriter a 45-day option to purchase up to 750,000 additional shares of its common stock. The offering is expected to close on or about January 19, 2021, subject to satisfaction of customary closing conditions.

    Laidlaw & Company (UK) Ltd. is acting…

    SOLANA BEACH, Calif., Jan. 13, 2021 (GLOBE NEWSWIRE) -- Evoke Pharma, Inc. (NASDAQ:EVOK), a specialty pharmaceutical company focused on treatments for gastrointestinal (GI) disorders and diseases, today announced that it has priced an underwritten public offering of 5,000,000 shares of its common stock at a price to the public of $2.50 per share. Gross proceeds, before underwriting discounts and commissions and estimated offering costs, are expected to be $12.5 million. Evoke has granted the underwriter a 45-day option to purchase up to 750,000 additional shares of its common stock. The offering is expected to close on or about January 19, 2021, subject to satisfaction of customary closing conditions.

    Laidlaw & Company (UK) Ltd. is acting as sole book-running manager for the offering.

    Evoke intends to use the net proceeds from the offering for working capital and general corporate purposes, including funding commercialization activities, research and development activities, clinical trial expenditures, and possible acquisition of new technologies or products.

    The offering is being conducted pursuant to a shelf registration statement (File No. 333-251614) previously filed and declared effective by the Securities and Exchange Commission (SEC). A final prospectus supplement and accompanying prospectus relating to this offering will be filed with the SEC and will be available free of charge on the website of the SEC at www.sec.gov. When available, copies of the final prospectus supplement and the accompanying prospectus relating to this offering may be obtained from Laidlaw & Company (UK) Ltd, Attention: Syndicate Department, 521 Fifth Avenue, New York, NY 10175, by telephone at (212) 953-4917 or by email at .

    This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of, these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or jurisdiction.

    About Evoke Pharma, Inc.

    Evoke is a specialty pharmaceutical company focused primarily on the commercialization and development of drugs to treat GI disorders and diseases. The Company developed 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.

    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 Evoke's current beliefs and expectations. These forward-looking statements include statements regarding Evoke's expectations on the completion, timing and size of the offering and the anticipated use of proceeds therefrom. 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 associated with market conditions and the satisfaction of customary closing conditions related to the proposed public offering and other risks and uncertainties inherent in Evoke's business, including those described in Evoke's periodic filings with the SEC and the prospectus supplement and related prospectus for this offering filed with the SEC. 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 Contact:

    The Ruth Group

    Jan Medina, CFA

    Tel: 646-536-7035

    Media Contact:

    The Ruth Group

    Annika Parrish

    Tel: 720-412-9042



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  3. SOLANA BEACH, Calif., Jan. 13, 2021 (GLOBE NEWSWIRE) -- Evoke Pharma, Inc. (NASDAQ:EVOK), a specialty pharmaceutical company focused on treatments for gastrointestinal (GI) disorders and diseases, today announced that it intends to offer and sell shares of its common stock in a "firm commitment" underwritten public offering. Evoke also expects to grant to the underwriter for the offering a 45-day option to purchase an additional 15% of the shares of common stock offered in the public offering to cover over-allotments, if any. All of the shares to be sold in the offering are to be sold by Evoke. The offering is subject to market conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual…

    SOLANA BEACH, Calif., Jan. 13, 2021 (GLOBE NEWSWIRE) -- Evoke Pharma, Inc. (NASDAQ:EVOK), a specialty pharmaceutical company focused on treatments for gastrointestinal (GI) disorders and diseases, today announced that it intends to offer and sell shares of its common stock in a "firm commitment" underwritten public offering. Evoke also expects to grant to the underwriter for the offering a 45-day option to purchase an additional 15% of the shares of common stock offered in the public offering to cover over-allotments, if any. All of the shares to be sold in the offering are to be sold by Evoke. The offering is subject to market conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.

    Laidlaw & Company (UK) Ltd. is acting as sole book-running manager for the offering. Evoke intends to use the net proceeds from the offering for working capital and general corporate purposes, including funding commercialization activities, research and development activities, clinical trial expenditures, and possible acquisition of new technologies or products.

    The offering is being conducted pursuant to a shelf registration statement (File No. 333-251614) previously filed and declared effective by the Securities and Exchange Commission (SEC). A preliminary prospectus supplement and accompanying prospectus relating to this offering will be filed with the SEC and will be available free of charge on the website of the SEC at www.sec.gov. When available, copies of the preliminary prospectus supplement and the accompanying prospectus relating to this offering may be obtained from Laidlaw & Company (UK) Ltd, Attention: Syndicate Department, 521 Fifth Avenue, New York, NY 10175, by telephone at (212) 953-4917 or by email at .

    This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of, these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or jurisdiction.

    About Evoke Pharma, Inc.

    Evoke is a specialty pharmaceutical company focused primarily on the commercialization and development of drugs to treat GI disorders and diseases. The Company developed 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.

    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 Evoke's current beliefs and expectations. These forward-looking statements include statements regarding Evoke's expectations on the completion and timing of the offering and the anticipated use of proceeds therefrom. 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 associated with market conditions and the satisfaction of customary closing conditions related to the proposed public offering and other risks and uncertainties inherent in Evoke's business, including those described in Evoke's periodic filings with the SEC and the prospectus supplement and related prospectus for this offering filed with the SEC. 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 Contact:

    The Ruth Group

    Jan Medina, CFA

    Tel: 646-536-7035

    Media Contact:

    The Ruth Group

    Annika Parrish

    Tel: 720-412-9042



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    View Full Article Hide Full Article
  4. SOLANA BEACH, Calif., Jan. 13, 2021 (GLOBE NEWSWIRE) -- Evoke Pharma, Inc. ("Evoke" or the "Company") (NASDAQ:EVOK), a specialty pharmaceutical company focused on treatments for gastrointestinal (GI) disorders and diseases, today announced positive findings from the first market research for GIMOTI following its launch during the fourth quarter of 2020.

    During December 2020, Evoke through its marketing partner, EVERSANA, conducted an ATU (Awareness, Trial, and Usage) Study, a quantitative survey to measure physician awareness, trial, and product usage, for GIMOTI. Approximately 104 total physician responses were captured. Survey respondents were split into three groups drawn from the healthcare practitioner (HCP) community; "target" gastroenterologists…

    SOLANA BEACH, Calif., Jan. 13, 2021 (GLOBE NEWSWIRE) -- Evoke Pharma, Inc. ("Evoke" or the "Company") (NASDAQ:EVOK), a specialty pharmaceutical company focused on treatments for gastrointestinal (GI) disorders and diseases, today announced positive findings from the first market research for GIMOTI following its launch during the fourth quarter of 2020.

    During December 2020, Evoke through its marketing partner, EVERSANA, conducted an ATU (Awareness, Trial, and Usage) Study, a quantitative survey to measure physician awareness, trial, and product usage, for GIMOTI. Approximately 104 total physician responses were captured. Survey respondents were split into three groups drawn from the healthcare practitioner (HCP) community; "target" gastroenterologists currently being called on by the field sales force (n = 61), other "non-target" gastroenterologists (n = 19), and primary care physicians (PCPs) who are not currently targeted for messaging (n = 24). Areas of interest that were queried included initial and future potential prescribing trends, and how HCPs viewed the suitability of GIMOTI in certain gastroparesis patient populations.

    Key Findings:

    • Indicated an intent to prescribe GIMOTI:
      • 79% of target gastroenterologists.
      • 89% of non-target gastroenterologists.
      • 50% of PCPs.
    • Out of those target gastroenterologists indicating an intent to prescribe GIMOTI, 94% indicated GIMOTI would be "appropriate" to use in moderate to severe patients.
    • A majority of each of the target and non-target gastroenterologists noted they intend to prescribe GIMOTI for both new and existing gastroparesis patients.
    • Nineteen of all participating HCPs indicated that they have already written a prescription for GIMOTI.
      • HCPs indicated that the primary driver for prescribing GIMOTI was patients being switched to GIMOTI due to lack of efficacy of current treatments.

    "While only a little over 10 weeks into our commercial launch, and occurring coincident with the pandemic environment and a holiday period, we are pleased with the ATU findings as they provide further direction for our commercial team and demonstrate that the GIMOTI message is hitting home, both with targeted and non-targeted healthcare care providers," commented David Gonyer, R.Ph., Evoke Pharma President and CEO.

    "Patients with diabetic gastroparesis often do not attain suitable relief from symptoms with oral treatments. This may be due to erratic absorption of orally administered drugs related to delayed gastric emptying or from vomiting up oral medications. Unfortunately, all traditional outpatient treatments used to manage symptoms of this disease are oral. GIMOTI is administered nasally, bypassing the GI system, with direct bloodstream delivery via the nasal membrane. This avoids the problem of unpredictable stomach emptying," stated Richard McCallum, MD, Division of Gastroenterology, Center for Neurogastroenterology and GI Motility, Texas Tech University Health Sciences Center El Paso. "I've been waiting for an alternative treatment like this for a long time. It is a major step forward in the treatment of gastroparesis and it will help many of my patients."

    "We are pleased with the ATU results and encouraged with recent feedback our 27 Gastroenterology Care Specialists are receiving from providers," added Chris Quesenberry, Chief Commercial Officer. "The results of the market research follow the positive reception we are hearing from doctors who desire an alternative to existing oral therapies. They indicate that a nasal route of administration that bypasses the GI tract makes sense for this underserved patient population. In 2021, we will continue to build on the commercial launch of GIMOTI to increase awareness and ensure that patients and their providers have access to this important brand."

    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 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. Visit www.EvokePharma.com for more information.

    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 (ChildPugh 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 EVERSANA Life Science Services, LLC

    EVERSANA™ is a leading provider of global services to the life science industry. The company's integrated solutions are rooted in the patient experience and span all stages of the product lifecycle 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 science 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: potential future prescribing trends for GIMOTI based on this survey of HCPs or the Company's marketing efforts; and Evoke's commercialization plans, including its plans to increase awareness and access to GIMOTI. 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's and EVERSANA's ability to successfully drive market demand for GIMOTI; the results of the ATU survey may not predict prescribing trends by doctors or acceptance by patients, and are not intended to reflect or imply actual prescriptions or sales to date; Evoke's ability to obtain additional financing as needed to support its operations, including through the EVERSANA line of credit which is subject to certain customary conditions; the COVID-19 pandemic may disrupt Evoke's and EVERSANA's business operations impairing the ability to commercialize GIMOTI and Evoke's ability to generate any product revenue; 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 obtain and maintain intellectual property protection for GIMOTI; and other risks 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 Contact:

    The Ruth Group

    Jan Medina, CFA

    Tel: 646-536-7035



    Media Contact:

    The Ruth Group

    Annika Parrish

    Tel: 720-412-9042



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  5. Gimoti™ commercial launch underway

    SOLANA BEACH, Calif., Nov. 10, 2020 (GLOBE NEWSWIRE) -- Evoke Pharma, Inc. (NASDAQ:EVOK), a specialty pharmaceutical company focused on treatments for gastrointestinal (GI) diseases, today announced its financial results for the third quarter ended September 30, 2020 and recent corporate developments.

    "The third quarter was marked by preparation for the commercial launch of GIMOTI, which we successfully implemented in early fourth quarter. The launch of GIMOTI to treat symptoms of acute and recurrent diabetic gastroparesis with our commercial partner EVERSANA marked a pivotal event for the Company," said David A. Gonyer, R.Ph., President and CEO of Evoke Pharma. "As a nasally delivered product, GIMOTI has…

    Gimoti™ commercial launch underway

    SOLANA BEACH, Calif., Nov. 10, 2020 (GLOBE NEWSWIRE) -- Evoke Pharma, Inc. (NASDAQ:EVOK), a specialty pharmaceutical company focused on treatments for gastrointestinal (GI) diseases, today announced its financial results for the third quarter ended September 30, 2020 and recent corporate developments.

    "The third quarter was marked by preparation for the commercial launch of GIMOTI, which we successfully implemented in early fourth quarter. The launch of GIMOTI to treat symptoms of acute and recurrent diabetic gastroparesis with our commercial partner EVERSANA marked a pivotal event for the Company," said David A. Gonyer, R.Ph., President and CEO of Evoke Pharma. "As a nasally delivered product, GIMOTI has distinct differences over oral formulations of metoclopramide. It is the only outpatient non-oral treatment option to help improve the quality of life for patients suffering with diabetic gastroparesis. Initial prescriptions of GIMOTI have already been filled at the EVERSANA specialty pharmacy through our patient support team at EvokeAssist™. We believe this vital support program will aid both physicians and patients through enrollment, reimbursement, and delivery of GIMOTI directly to the patient. Given the milestones achieved for commercial preparedness, we believe we are in a strong position as we launch GIMOTI and address a significant unmet medical need for millions of patients suffering from diabetic gastroparesis."

    Third Quarter 2020 Developments and Recent Progress:

    • Launched GIMOTI with commercial partner, EVERSANA, in line with prior guidance
    • Implemented EvokeAssist, an integrated patient support program
    • Appointed Chris Quesenberry as Chief Commercial Officer for GIMOTI through our Commercial partner, EVERSANA
    • Built an entire commercial team, including field sales and call center
    • Completed manufacturing of the first commercial lot of GIMOTI

    Third Quarter 2020 Financial Review

    For the third quarter of 2020, net loss was approximately $2.1 million, or $0.08 per share, compared to a net loss of approximately $1.6 million, or $0.07 per share, for the third quarter of 2019.

    Research and development expenses totaled approximately $0.2 million for the third quarter of 2020, compared to approximately $0.8 million for the third quarter of 2019. The decrease during the three months ended September 30, 2020 was primarily due to the decrease in research and development activity following the GIMOTI NDA approval in June 2020.

    For the third quarter of 2020, general and administrative expenses were approximately $1.9 million compared to approximately $0.8 million for the third quarter of 2019. The increase during the three months ended September 30, 2020 was primarily due to increased costs associated with our commercialization and selling activities. Of the costs incurred during the third quarter of 2020, approximately $745,000 were related to commercialization activities.

    Total operating expenses for the third quarter of 2020 were approximately $2.1 million, compared to total operating expenses of approximately $1.6 million for the third quarter of 2019.

    As of September 30, 2020, the Company's cash and cash equivalents were approximately $6.3 million. The Company expects that its current cash balance will be sufficient to support operations into the second quarter of 2021, without consideration of potential future GIMOTI revenue.

    About Evoke Pharma, Inc.

    Evoke is a specialty pharmaceutical company focused primarily on the commercialization and development of drugs to treat GI disorders and diseases. The Company developed GIMOTI, a nasal spray formulation of metoclopramide, for the relief of symptoms associated with acute and recurrent diabetic gastroparesis in adults. GIMOTI is available by prescription through the EvokeAssist™ patient support center. Visit www.GimotiRx.com for more information.

    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. GIMOTI is absorbed in the nasal cavity and bypasses the erratic gastric absorption often seen in gastroparesis patients. Prior to FDA approval to commercially market GIMOTI, metoclopramide was only available in oral and injectable formulations. It remains the only drug currently approved in the United States to treat gastroparesis. Visit www.EvokePharma.com for more information.

    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 (ChildPugh 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.

    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: the size of the gastroparesis market and the potential of GIMOTI to provide an important new alternative to current treatment options. 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's and EVERSANA's ability to successfully drive market demand for GIMOTI; Evoke's ability to obtain additional financing as needed to support its operations, including through the EVERSANA line of credit which is subject to certain customary conditions; the COVID-19 pandemic may disrupt Evoke's and EVERSANA's business operations impairing the ability to commercialize GIMOTI and Evoke's ability to generate any product revenue; 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 obtain and maintain intellectual property protection for GIMOTI; and other risks 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.

    TABLES TO FOLLOW

    Evoke Pharm, Inc.

    Balance Sheets

     September 30, 2020 December 31, 2019
     (Unaudited)  
    Assets   
    Current Assets:   
    Cash and cash equivalents$6,280,656  $5,663,833 
    Prepaid expenses 336,432   581,706 
    Inventory 86,145    
    Other current assets 11,551    
    Total current assets 6,714,784   6,245,539 
    Operating lease right-of-use asset 36,115   138,538 
    Other assets    11,551 
    Total assets$6,750,899  $6,395,628 
        
    Liabilities and stockholders' equity   
    Current Liabilities:   
    Accounts payable and accrued expenses$765,603  $1,033,383 
    Accrued compensation 715,423   843,162 
    Operating lease liability 36,115   138,538 
    Paycheck protection program loan 104,168    
    Milestone payable 5,000,000    
    Total current liabilities 6,621,309   2,015,083 
        
    Long-term Liabilities:   
    Note payable 2,000,000    
    Accrued interest payable 53,005    
    Total long-term liabilities 2,053,005    
        
    Total liabilities 8,674,314   2,015,083 
        
    Stockholders' equity:   
    Common stock 2,633   2,443 
    Additional paid-in capital 94,691,151   90,108,492 
    Accumulated deficit (96,617,199)  (85,730,390)
    Total stockholders' (deficit) equity (1,923,415)  4,380,545 
    Total liabilities and stockholders' (deficit) equity$6,750,899  $6,395,628 
        

    Evoke Pharma, Inc.

    Statement of Operations

    (Unaudited)


     Three Months Ended September 30, Nine Months Ended September 30,
      2020   2019   2020   2019 
    Operating expenses:       
    Research and development$205,032  $822,444  $6,450,979  $2,774,924 
    General and administrative 1,874,578   814,218   4,387,284   2,955,371 
    Total operating expenses 2,079,610   1,636,662   10,838,263   5,730,295 
    Loss from operations (2,079,610)  (1,636,662)  (10,838,263)  (5,730,295)
    Other income (expense):       
    Interest income 1,033   8,597   4,896   22,868 
    Interest expense (50,528)     (53,442)   
    Total other income (expense), net (49,495)  8,597   (48,546)  22,868 
    Net loss$(2,129,105) $(1,628,065) $(10,886,809) $(5,707,427)
            
    Net loss per share of common stock, basic and diluted$(0.08) $(0.07) $(0.43) $(0.26)
            
    Weighted-average shares used to compute basic and diluted net loss per share 26,146,220   24,128,060   25,191,359   21,623,648 
            

    Investor Contact:

    The Ruth Group

    Jan Medina, CFA

    Tel: 646-536-7035



    Media Contact:

    The Ruth Group

    Kirsten Thomas

    Tel: 508-280-6592



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