UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, DC 20549

 

FORM 8-K

 

CURRENT REPORT

Pursuant to Section 13 or 15(d) of

the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported):  April 30, 2018

 

EVOKE PHARMA, INC.

(Exact Name of Registrant as Specified in its Charter)

 

 

Registrant’s telephone number, including area code: (858) 345-1494

(Former Name or Former Address, if Changed Since Last Report.)

 

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 (see General Instruction A.2. below):

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 8.01    Other Event.

 

On April 30, 2018, Evoke Pharma, Inc. (the “Company”) announced that the European Patent Office has issued a Decision to Grant European Union (EU) patent no. 2747561 for Gimoti™, covering formulations of metoclopramide for intranasal delivery for the treatment of symptoms associated with diabetic gastroparesis specifically for women. The notice confirms that the patent grant applies to 38 covered member states and will be published on May 9, 2018 with patent expiry extended to 2032.

 

Gastroparesis, which often compromises the ability for oral medications to pass through the stomach to allow predictable absorption, remains a significant burden on patients, 80% of whom are women. Through Evoke’s extensive research in this disease space, it has developed Gimoti, its intranasal formulation of metoclopramide intended to deliver an effective medication while bypassing the dysfunctional stomach. This non-oral treatment is critical in relieving symptoms of this disease, where approximately 4 million prescriptions of oral metoclopramide are written each year in the United States.

 

The Company is currently preparing to submit its 505(b)2 New Drug Application (NDA) for Gimoti to the U.S. Food and Drug Administration (FDA) within the second quarter 2018. The Company will also include definitive evidence from safety, efficacy and pharmacokinetic trials, including over 1,400 subjects, with the NDA in seeking FDA approval for Gimoti.

 

 

Safe Harbor Statement

 

The Company cautions you that statements included in this report 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 timing of the European patent to be published by the European Patent Office; the anticipated expiration date of the European patent; anticipated timing to submit an NDA for Gimoti; and the potential timing of FDA approval, if any, of the NDA for 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 the Company’s business, including, without limitation: the Company may spend its available cash faster than it anticipates; the FDA may disagree that the existing safety database is sufficient to allow an NDA submission and approval; risks associated with FDA review of the final results from the comparative exposure pharmacokinetic (PK) trial, including the FDA may not agree with the Company’s interpretation of such results; later developments with the FDA that may be inconsistent with the already completed pre-NDA meetings and most recent correspondence; the inherent risks of clinical development of Gimoti; the Company may not be able to obtain, maintain and enforce its patents and other intellectual property rights, and it may be prohibitively difficult or costly to protect such rights; the scope of the patent to be issued by the European Patent Office may not provide the protections the Company expects; the Company is entirely dependent on the success of Gimoti, and the Company cannot be certain that it will be able to submit an NDA for Gimoti or obtain regulatory approval for or successfully commercialize Gimoti; the Company will require substantial additional funding to conduct any new safety trials required by the FDA, and may be unable to raise capital when needed, including to fund ongoing operations; and other risks detailed in the Company’s 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 the Company undertakes no obligation to revise or update this report 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.

 

---

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.