Form 8-K - 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): November 21, 2023

 

DMK PHARMACEUTICALS CORPORATION

(Exact Name of Registrant as Specified in its Charter)

 

Delaware		0-26372		82-0429727
(State or other jurisdiction of incorporation)		(Commission File Number)		(IRS Employer Identification No.)

 

11622 El Camino Real, Suite 100 San Diego, CA		92130
(Address of Principal Executive Offices)		(Zip Code)

 

Registrant’s telephone number, including area code: [phone]

 

(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))

 

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		DMK		NASDAQ Capital Market

 

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 1.02

Termination of a Material Definitive Agreement.

 

Effective November 21, 2023, the contract between DMK Pharmaceuticals Corporation (the “Company”) and USWM, LLC (“USWM” or “US WorldMeds”) was terminated as to its SYMJEPI (epinephrine) Injection 0.3mg and SYMJEPI (epinephrine) Injection 0.15mg products. US WorldMeds previously held exclusive distribution and commercialization rights for SYMJEPI and ZIMHI (naloxone) products in the United States, and was responsible for marketing, promotion and distribution efforts. The distribution agreement between the Company and US WorldMeds remains in effect with respect to ZIMHI.

 

Item 8.01

Other Events.

 

On November 28, 2023, DMK Pharmaceuticals Corporation (the “Company”) issued a press release regarding the termination of the distribution contract for its SYMJEPI projects. A copy of the Company’s press release announcing this information and certain other information is attached hereto as Exhibit 99.1 and is incorporated herein by reference.

 

Cautionary Note Regarding Forward Looking Statements

 

This Current Report on Form 8-K contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are identified by terminology such as “may,” “should,” “expects,” “plans,” “anticipates,” “could,” “intends,” “target,” “projects,” “contemplates,” “believes,” “estimates,” “predicts,” “potential” or “continue” or the negative of these terms or other similar words. Such forward-looking statements include those that express plans, anticipation, intent, contingencies, goals, targets or future development and/or otherwise are not statements of historical fact. These statements may relate to anticipated future events or future results of operations, including, but not limited to, statements concerning (i) the creation of federal guidelines to remove barriers to access opioid reversal products at the state and local levels, (ii) the likelihood of passage of congressional legislation designed to improve access to naloxone, (iii) the effectiveness of ZIMHI in reversing the effects of opioid overdose and (iv) the market potential of SYMJEPI. These statements are only predictions and involve known and unknown risks, uncertainties, and other factors, which may cause the Company’s actual results to be materially different from the results anticipated by such forward-looking statements. Accordingly, you should not rely upon forward-looking statements as predictions of future events. The Company cannot assure you that the events and circumstances reflected in the forward-looking statements will be achieved or occur, and actual results could differ materially from those projected in the forward-looking statements. 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 SEC, including its annual report on Form 10-K and subsequent filings with the SEC, which the Company strongly urges you to read and consider, all of which are available free of charge on the SEC’s website at http://www.sec.gov.

 

Item 9.01

Financial Statements and Exhibits

 

Exhibit No.	Description
99.1	Press Release issued November 28, 2023.
104	Cover Page Interactive Data File (embedded within the Inline XBRL document)

 

 

SIGNATURE

 

Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the Registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

	DMK PHARMACEUTICALS CORPORATION
Dated:  November 28, 2023	By:	/s/ Seth A. Cohen
	Name:	Seth A. Cohen
	Title:	Chief Financial Officer

 

  

 

 

DMK Pharmaceuticals Corporation 8-K

Exhibit 99.1

 

 

 

 

 

 

DMK Pharmaceuticals Regains Full Rights from US WorldMeds for SYMJEPI® and Provides Corporate Update

Now seeking out license opportunities for SYMJEPI®

 

 

Your publication date and time will appear here.

|  Source: DMK Pharmaceuticals Corporation

 

 

 

 

 

SAN DIEGO, Nov. 28, 2023 (GLOBE NEWSWIRE) -- DMK Pharmaceuticals Corporation (NASDAQ: DMK), a commercial stage neuro-biotech company primarily focused on developing and commercializing products for the treatment of opioid overdose and substance use disorders, today announced that it is reacquiring the rights to its SYMJEPI^® (epinephrine) Injection 0.3mg and SYMJEPI^® (epinephrine) Injection 0.15mg products from USWM, LLC (“USWM” or “US WorldMeds”). US WorldMeds previously held exclusive distribution and commercialization rights for SYMJEPI^® and ZIMHI^® (naloxone) products in the United States, and was responsible for  marketing, promotion and distribution efforts.

The Company is now actively seeking out-license opportunities for SYMJEPI^® in the US and globally, in addition to exploring other options with a focus on maximizing value for shareholders.

 

“Given our renewed focus on our core business, we are taking decisive actions that we believe will remove obstacles and improve our ability to drive long-term growth,” said Eboo Versi, M.D., Ph.D., CEO of DMK Pharmaceuticals. “This represents an important step in DMK’s ongoing transformation journey as we continue to execute against our operating plan and review our existing business relationships to ensure maximal benefit to DMK’s stakeholders and patients.”

 

  

 

About DMK Pharmaceuticals

DMK Pharmaceuticals is a commercial stage neuro-biotech company primarily focused on developing and commercializing products for the treatment of opioid overdose and substance use disorders. DMK’s commercial products approved by the FDA include ZIMHI^® (naloxone) Injection for the treatment of opioid overdose, and SYMJEPI^® (epinephrine) Injection for use in the emergency treatment of acute allergic reactions, including anaphylaxis. The Company is focused on developing novel therapies for opioid use disorder (OUD) and other important neuro-based conditions where patients are currently underserved. DMK believes its technologies are at the forefront of endorphin-inspired drug design with its mono, bi- and tri-functional small molecules that simultaneously modulate critical networks in the nervous system. DMK has a library of approximately 750 small molecule neuropeptide analogues and a differentiated pipeline that could address unmet medical needs by taking the novel approach to integrate with the body’s own efforts to regain balance of disrupted physiology. The Company’s lead clinical stage product candidate, DPI- 125, is being studied as a potential novel treatment for OUD. DMK also plans to develop the compound for the treatment of moderate to severe pain. The Company’s other development stage product candidates include DPI-221 for bladder control problems and DPI-289 for severe end stage Parkinson’s disease. For additional information about DMK Pharmaceuticals, please visit our website and follow us on Twitter and LinkedIn.

 

Forward Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are identified by terminology such as “may,” “should,” “expects,” “plans,” “anticipates,” “could,” “intends,” “target,” “projects,” “contemplates,” “believes,” “estimates,” “predicts,” “potential” or “continue” or the negative of these terms or other similar words. Such forward-looking statements include those that express plans, anticipation, intent, contingencies, goals, targets or future development and/or otherwise are not statements of historical fact. These statements relate to anticipated future events or future results of operations, including, but not limited to, statements concerning (i) the ability of the Company to raise additional funds required to sustain the Company’s ongoing operations and fund the anticipated development activities regarding DPI-125, (ii) whether, if successfully developed, DPI-125 will receive a more favorable drug scheduling or be a more patient friendly treatment, (iii) the potential benefits of DPI-125 if successfully developed, and (iv) our ability to increase sales of our commercial products.

  

 

These statements are only predictions and involve known and unknown risks, uncertainties, and other factors, which may cause Adamis’ actual results to be materially different from the results anticipated by such forward-looking statements. These statements also assume that the Company will have or be able to obtain sufficient funding to support the activities described in this press release, continue the Company’s operations and satisfy the Company’s liabilities and obligations in a timely manner. There can be no assurance that this will be the case. Also, such statements assume that there are no significant unexpected developments or events that delay or prevent such activities from occurring. The Company will require additional funds to sustain operations, satisfy our obligations and liabilities, and fund its ongoing operations. There are no assurances that required funding will be available at all or will be available in sufficient amounts. Failure to timely obtain any required additional funding, or unexpected developments or events, could delay the occurrence of such events or prevent the events described in any such statements from occurring which could adversely affect our business, financial condition and results of operations. If we cannot continue as a viable entity, we might be required to reduce or cease operations or seek dissolution and liquidation or bankruptcy protection, and our stockholders would likely lose most or all of their investment in us. Accordingly, you should not rely upon forward-looking statements as predictions of future events. Adamis cannot assure you that the events and circumstances reflected in the forward-looking statements will be achieved or occur, and actual results could differ materially from those projected in the forward-looking statements. 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 press release. Certain of these risks and additional risks, uncertainties, and other factors are described in greater detail in Adamis’ filings from time to time with the SEC, including its annual report on Form 10-K for the year ended December 31, 2022, 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 website at http ://www.sec.gov.

Investor and Media Contact:

Maria Yonkoski

ICR Westwicke
203-682-7167

 

 

 

 

Tags

 

  

Cover	Nov. 21, 2023
Cover [Abstract]
Document Type	8-K
Amendment Flag	false
Document Period End Date	Nov. 21, 2023
Entity File Number	0-26372
Entity Registrant Name	DMK PHARMACEUTICALS CORPORATION
Entity Central Index Key	0000887247
Entity Tax Identification Number	82-0429727
Entity Incorporation, State or Country Code	DE
Entity Address, Address Line One	11622 El Camino Real
Entity Address, Address Line Two	Suite 100
Entity Address, City or Town	San Diego
Entity Address, State or Province	CA
Entity Address, Postal Zip Code	92130
City Area Code	(858)
Local Phone Number	997-2400
Written Communications	false
Soliciting Material	false
Pre-commencement Tender Offer	false
Pre-commencement Issuer Tender Offer	false
Title of 12(b) Security	Common Stock
Trading Symbol	DMK
Security Exchange Name	NASDAQ
Entity Emerging Growth Company	false

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