UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
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Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
Securities registered pursuant to Section 12(b) of the Act:
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Trading |
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Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).
Emerging growth company
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Item 2.02 Results of Operations and Financial Condition.
On November 7, 2024, Evoke Pharma, Inc. issued a press release announcing its financial results for the third quarter ended September 30, 2024. A copy of the press release is attached hereto as Exhibit 99.1 and is incorporated herein by reference.
In accordance with General Instruction B.2 of Form 8-K, the information in this Current Report on Form 8-K, including Exhibit 99.1, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, whether made before or after the date hereof, except as expressly set forth by specific reference in such filing.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits
Exhibit No |
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Description |
99.1 |
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104 |
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Cover Page Interactive Data File (embedded within the Inline XBRL document) |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
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EVOKE PHARMA, INC. |
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Date: |
November 7, 2024 |
By: |
/s/ Matthew J. D’Onofrio |
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Name: Matthew J. D’Onofrio |
Evoke Pharma, Inc. Reports Third Quarter 2024 Financial Results
GIMOTI third quarter net product sales of $2.7 million, highest quarterly revenue ever with a 70% increase year-over-year
Strong cumulative prescriber growth, 45% year-over-year increase
52% year-over-year prescription fill increase; 39% increase since Q1 2024
Real-world data presented at ACG 2024 demonstrates that GIMOTI significantly enhanced outcomes for patients on GLP-1 therapy, marking it as a promising supportive care option compared to oral metoclopramide.
SOLANA BEACH, Calif., November 7, 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, today announced its financial results for the third quarter ended September 30, 2024, and recent corporate developments.
“We are encouraged by the strong year-over-year growth metrics we continue to see for GIMOTI, including a 70% year-over- year increase in net product sales and significant gains in prescriber and prescription fill rates. We continue to grow revenue with this being the highest quarter of revenue on record” said Matt D’Onofrio, CEO of Evoke Pharma. “The strong response to GIMOTI among healthcare providers and patients underscores its growing value as an innovative non-oral treatment option for diabetic gastroparesis. With award-winning real-world data presented at ACG 2024, GIMOTI has demonstrated its potential to treat diabetic gastroparesis even with those undergoing GLP-1 therapy.”
“The recent data presented at ACG 2024 highlights GIMOTI’s ability to significantly reduce healthcare visits, including hospitalizations, underscoring the need for better alternatives to traditional oral treatments. Coupled with our strategic initiatives to expand access and engage more prescribers, we are well-positioned to increase GIMOTI’s reach and help more patients find meaningful relief. The positive feedback from both patients and providers strengthens our resolve to reshape the care paradigm and ensure that people with gastroparesis have access to an effective and innovative option like GIMOTI,” said Chris Quesenberry, Chief Commercial Officer of GIMOTI.
“Our dedicated mission is to challenge the notion that gastroparesis 'patients are doing fine' with current treatment options, as we know firsthand that many individuals with diabetic gastroparesis continue to struggle despite existing therapies. According to a survey from IFFGD (gastroenterology patient support organization), 65% of patients with Diabetic Gastroparesis are dissatisfied with current therapies. Based on these data and the efficacy of GIMOTI, we believe patients may benefit by switching from oral to nasally-administered GIMOTI. It is directly absorbed into the bloodstream and does not rely on a dysfunctional stomach to work. In GIMOTI,
providers have an alternative to help patients they did not previously think they could help as well as an option to re-challenge patients who did not have optimal efficacy using oral medications.” Chris added.
Third Quarter 2024 and Year-to-Date Developments and Recent Highlights:
Third Quarter 2024 Financial Review and Outlook
For the third quarter of 2024, net product sales were approximately $2.7 million compared to $1.6 million during the third quarter of 2023, and the net loss was approximately $1.3 million, or $0.94 per share compared with $1.7 million, or $6.08 per share, for the third quarter of 2023.
For the third quarter of 2024, selling, general and administrative expenses were approximately $3.8 million compared to $3.1 million for the third quarter of 2023. The $0.7 million increase was due to higher professional fees and reimbursement for expanded marketing efforts and profit-sharing activity with EVERSANA.
Total operating expenses for the third quarter of 2024 were approximately $3.9 million compared to $3.2 million for the same period in 2023.
Based on net sales generated in the first three quarters of 2024, Evoke is revising its 2024 guidance to $9.5-10.0 million from a range of $11- 12 million, still reflecting almost a doubling from the previous year, if achieved. Evoke’s 2024 guidance is dependent on its current business and expectations, including recent growth rates in net sales, assumptions regarding reimbursements and prescription fills, as well as factors that are outside of our control, such as the global macroeconomic and geopolitical environment, continued supply chain constraints and inflationary pressures.
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.
Visit www.EvokePharma.com for more information.
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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
GIMOTI is not recommended for use in:
GIMOTI is contraindicated:
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, effectson 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: guidance regarding 2024 net product sales; potential future prescribing trends for GIMOTI based on Evoke’s or EVERSANA’s marketing efforts; Evoke’s commercialization plans, including the potential that GIMOTI could become the standard of care for gastroparesis; the potential for additional funds from the exercise of outstanding warrants and Evoke’s expected cash runway. 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 its guidance for 2024 including as a result of decreased demand for GIMOTI; 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; 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
Evoke Pharma, Inc.
Condensed Balance Sheets
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September 30, 2024 |
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December 31, 2023 |
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(unaudited) |
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Assets |
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Current assets: |
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Cash and cash equivalents |
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$ |
11,339,032 |
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$ |
4,739,426 |
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Accounts receivable, net of allowance for credit losses of $0 |
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2,022,518 |
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673,071 |
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Prepaid expenses |
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146,704 |
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885,040 |
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Inventories |
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493,408 |
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481,840 |
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Other current assets |
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36,421 |
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47,532 |
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Total current assets |
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14,038,083 |
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6,826,909 |
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Deferred offering costs |
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115,488 |
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241,637 |
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Total assets |
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$ |
14,153,571 |
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$ |
7,068,546 |
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Liabilities and stockholders' equity (deficit) |
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Current liabilities: |
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Accounts payable and accrued expenses |
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$ |
2,188,164 |
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$ |
1,711,778 |
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Accrued compensation |
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590,634 |
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1,324,010 |
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Note payable |
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5,000,000 |
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5,000,000 |
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Accrued interest payable |
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1,987,637 |
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1,612,295 |
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Total current liabilities |
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9,766,435 |
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9,648,083 |
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Total liabilities |
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9,766,435 |
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9,648,083 |
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Commitments and contingencies |
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Stockholdersʼ equity (deficit): |
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Preferred stock, $0.0001 par value; authorized shares — 5,000,000 |
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— |
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— |
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Common stock, $0.0001 par value; authorized shares — 100,000,000 and |
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89 |
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28 |
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Additional paid-in capital |
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131,985,913 |
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120,859,873 |
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Accumulated deficit |
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(127,598,866 |
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(123,439,438 |
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Total stockholdersʼ equity (deficit) |
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4,387,136 |
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(2,579,537 |
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Total liabilities and stockholders' equity (deficit) |
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$ |
14,153,571 |
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$ |
7,068,546 |
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Evoke Pharma, Inc.
Condensed Statement of Operations
(unaudited)
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Three Months Ended September 30, |
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2024 |
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2023 |
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Net product sales |
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$ |
2,654,186 |
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$ |
1,562,860 |
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Operating expenses: |
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Cost of goods sold |
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104,024 |
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34,908 |
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Research and development |
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11,677 |
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— |
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Selling, general and administrative |
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3,824,142 |
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3,131,389 |
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Total operating expenses |
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3,939,843 |
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3,166,297 |
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Loss from operations |
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(1,285,657 |
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(1,603,437 |
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Other income (expense): |
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Interest income |
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99,294 |
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35,558 |
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Interest expense |
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(126,027 |
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(126,028 |
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Total other expense |
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(26,733 |
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(90,470 |
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Net loss |
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$ |
(1,312,390 |
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$ |
(1,693,907 |
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Net loss per share of common stock, basic and diluted |
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$ |
(0.94 |
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$ |
(6.08 |
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Weighted-average shares used to compute basic and diluted |
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1,399,882 |
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278,558 |
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