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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
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FORM 8-K
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CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
Date of Report (date of earliest event reported)
August 13, 2018
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electroCore, Inc.
(Exact name of registrant as specified in its charter)
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Delaware (State or other jurisdiction of incorporation or organization) | 001-38538 (Commission File Number) | 20-3454976 (I.R.S. Employer Identification Number) |
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150 Allen Road, Suite 201 | ||
(Address of principal executive offices and zip code) | ||
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(973) 290-0097 | ||
(Registrant's telephone number, including area code) | ||
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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:
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☐ | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
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☐ | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
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☐ | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
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☐ | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
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. ☒
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Item 2.02 Results of Operations and Financial Condition.
On August 13, 2018, electroCore, Inc. (the “Company”) issued a press release announcing its financial results for the quarter ended June 30, 2018. A copy of the press release is furnished herewith as Exhibit 99.1 and incorporated by reference.
The information contained in this Item 2.02 and Item 9.01 in this Form 8-K, including the accompanying Exhibit 99.1 hereto 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, regardless of any general incorporation language in such filings, unless expressly incorporated by specific reference in such filing.
Item 8.01 Other Events.
Based on existing clinical trial data, the Company expects to submit an application under Section 510(k) of the Federal Food, Drug and Cosmetic Act (a "510(k)") with the U.S. Food and Drug Administration ("FDA") before the end of 2018 to expand its label for its gammaCore therapy for the prevention of cluster headache. Currently, there are no approved treatments for cluster headache prevention. Following the potential release by FDA of gammaCore for cluster headache prevention, in consultation with FDA and its regulatory advisors, the Company expects to submit a 510(k) to expand the gammaCore label to prevention of migraine headache in adults. The Company maintains its intention to initiate an additional pivotal trial for gammaCore for the prevention of migraine in the second half of 2018, and to present full data from its PREMIUM trial for prevention of migraine at a medical congress before the end of 2018.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits.
Exhibit No. | Description of Exhibit |
99.1 |
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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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| electroCore, Inc. | |
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August 13, 2018 | /s/ | Glenn S. Vraniak |
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| Glenn S. Vraniak |
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| Chief Financial Officer |
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