Form 8-K Adamis Pharmaceuticals For: Sep 21
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SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
of Report (Date of earliest event reported):
(Exact Name of Registrant as Specified in Charter)
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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 (see General Instruction A.2. below):
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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).
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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 8.01||Other Events|
On September 21, 2022, Adamis Pharmaceuticals Corporation (the “Company”) issued a press release announcing that the third planned interim analysis of the Phase 2/3 clinical trial examining the effects of the Company’s Tempol product candidate in high risk subjects with early COVID-19 infection did not achieve its primary endpoint, as measured by comparing the rate of sustained clinical resolution of symptoms of COVID-19 at day 14 of Tempol versus placebo. The independent Data Safety Monitoring Board (“DSMB”) conducting the interim review recommended that the study be halted early due to lack of efficacy. The DSMB did note that no safety concerns were identified in the subjects that received Tempol. Based on the recommendation from the DSMB, the Company has halted the trial and will evaluate the unblinded data from the trial to determine the next developmental steps for Tempol.
A copy of the Company’s press release is filed with this Report as Exhibit 99.1.
Forward Looking Statements
This Current Report on Form 8-K, and the press release filed as an exhibit with this Report, contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, that are subject to risks, uncertainties and other factors, including risks and uncertainties related to the next developmental steps for Tempol and the other factors referred to in the press release filed as an exhibit with this Report under the heading “Forward Looking Statements.” These risks, uncertainties and other factors could cause actual results to differ materially from those referred to in the forward-looking statements. In addition, forward-looking statements concerning our anticipated future activities assume that we have sufficient funding to support such activities and continue our operations and planned activities, which may not be the case. You should not place undue reliance on any forward-looking statements. Further, any forward-looking statement speaks only as of the date on which it is made, and except as may be required by applicable law, we undertake no obligation to update or release publicly the results of any revisions to these forward-looking statements or to reflect events or circumstances arising after the date of this Report. Certain of these risks and additional risks, uncertainties, and other factors are described in greater detail in the Company’s filings from time to time with the Securities and Exchange Commission, including its annual report on Form 10-K for the year ended December 31, 2021 and subsequent filings with the SEC, which Adamis strongly urges you to read and consider, all of which are available free of charge on the SEC's web site at http://www.sec.gov.
Item 9.01 Financial Statements and Exhibits.
|99.1||Press release dated September 21, 2022.|
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.
|ADAMIS PHARMACEUTICALS CORPORATION|
|Dated: September 21, 2022||By:||/s/ David C. Benedicto|
|Name:||David C. Benedicto|
|Title:||Chief Financial Officer|
ATTACHMENTS / EXHIBITS
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