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):  September 17, 2019

 

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 8.01Other Events.

On September 17, 2019, Evoke Pharma, Inc. (“Evoke” or “Company”) announced that it has completed manufacturing commercial scale batches of its product candidate Gimoti (metoclopramide nasal spray) with its partner Thermo Fisher Scientific, a leading global contract development and manufacturing organization that specializes in the preparation, fill and finish of nasal spray products.

 

Evoke plans to collect Chemistry, Manufacturing and Controls (“CMC”) data from these registration batches, which were requested in the complete response letter (“CRL”) from the U.S. Food and Drug Administration (“FDA”). These data will be used to support the proposed acceptance criteria for droplet size distribution and other performance characteristics and device quality control and will be included in Evoke’s planned resubmission of the 505(b)(2) New Drug Application (“NDA”) for Gimoti in the fourth quarter of this year.

 

 

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 Company’s plans to use the CMC data from the registration batches to support the resubmission of the Gimoti NDA; the addressability of the approvability issues cited by FDA in the CRL, including with respect to the performance characteristics and root cause analysis regarding the pharmacokinetic variability; and the potential for an NDA resubmission in the fourth quarter. The inclusion of forward-looking statements should not be regarded as a representation by the Company that any of its plans will be achieved. Actual results may differ from those set forth in this report due to the risks and uncertainties inherent in the Company’s business, including, without limitation: the CMC data from the registration batches may not support the acceptance criteria for droplet size distribution and other performance characteristics and device quality control; Evoke may be unable to timely and successfully address the deficiencies raised in the CRL, including as a result of adverse findings from a root cause analysis or data from the completed registration manufactured product batches; FDA may not agree with the Company’s conclusion of the root cause analysis or analysis of the CMC data from the registration batches or may require the Company to conduct additional studies; the inherent risks of clinical development of Gimoti; the Company’s dependence on third parties for the manufacture of Gimoti and analysis of the PK data; the Company is entirely dependent on the success of Gimoti, and the Company cannot be certain that FDA will accept or approve an NDA resubmission for Gimoti; The Company will require substantial additional funding to address the deficiencies raised in the CRL, and may be unable to raise capital or obtain funds when needed, including to fund ongoing operations; the Company could face significant additional costs due to litigation or other events; the Company’s ability to maintain the continued listing of its common stock on the Nasdaq Capital Market; and other risks detailed in the Company’s prior reports filed 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.