8-K 1 admp-8k_121919.htm CURRENT REPORT

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 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): December 19, 2019


 

ADAMIS PHARMACEUTICALS CORPORATION

(Exact Name of Registrant as Specified in Charter)

 

Delaware   0-26372   82-0429727

(State or other jurisdiction

of incorporation)

  (Commission File Number)  

(IRS Employer

Identification No.)

         

11682 El Camino Real, Suite 300

San Diego, CA

  92130
(Address of Principal Executive Offices)   (Zip Code)
             

 

Registrant’s telephone number, including area code: (858) 997-2400

 

(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):

 

Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
   
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
   
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
   
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. ☐

 

Securities registered pursuant to Section 12(b) of the Exchange Act:

 

Title of each class   Trading Symbol(s)   Name of each exchange on
which registered
Common Stock   ADMP   NASDAQ Capital Market

 

 
 

 

Item 8.01Other Events

On December 19, 2019, Adamis Pharmaceuticals Corporation (the “Company”) issued a press release providing an update on the ZIMHI™ New Drug Application (“NDA”) resubmission process.

On November 22, 2019, the Company received a Complete Response Letter (“CRL”) from the U.S. Food and Drug Administration (“FDA”) regarding its NDA for its ZIMHI™ high-dose naloxone injection product for the treatment of opioid overdose. The Company has provided responses to the comments included in the CRL and submitted these answers to the FDA. With the responses, the Company requested a Type A meeting with the FDA and is currently waiting for the FDA to respond to this request. The next update from the Company on the ZIMHI NDA resubmission process will be sometime after the FDA meeting occurs. At that time, the Company would expect to have more information regarding the timeline for the full resubmission of the NDA back to the FDA.

A copy of the Company’s press release is attached hereto as exhibit 99.1 and incorporated herein by reference.

Item 9.01Financial Statements and Exhibits

(d) Exhibits.

 

  99.1 Press release dated December 19, 2019.

 

 

 
 

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.

  ADAMIS PHARMACEUTICALS CORPORATION
     
     
     
Dated:  December 26, 2019 By: /s/ Robert O. Hopkins
  Name: Robert O. Hopkins
  Title: Chief Financial Officer