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): March 5, 2019
Nexien BioPharma, Inc.
(Exact name of registrant as specified in its charter)
Commission File No.: 0-55320
Delaware | 26-2049376 | |
(State or other jurisdiction of incorporation) | (I.R.S. Employer Identification No.) | |
4340 E Kentucky Ave, Suite 206, Glendale, CO | 80246 | |
(Address of principal executive offices) | (Zip Code) |
Registrant’s telephone number, including area code: (303) 495-7583
Not applicable
(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:
[ ] | 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 or Rule 12b-2 of the Securities Exchange Act of 1934.
Emerging growth company [X]
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 7.01 Regulation FD Disclosure.
On March 5, 2019, Nexien BioPharma, Inc. issued a press release about the acceptance of its patent application pertaining to the use of cannabinoids and terpenes for treatment of organophosphate and carbamate toxicity by the Israeli Patent Office. This Form 8-K and the information included as exhibits shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (“Exchange Act”), nor shall it be incorporated by reference into a filing under the Securities Act of 1933, as amended (“Securities Act”), or the Exchange Act, except as expressly set forth by specific reference in such a filing. The furnishing of the information in this report is not intended to, and does not, constitute a determination or admission by the Company that the information in this report is material or complete, or that investors should consider this information before making an investment decision with respect to any security of the Registrant or any of its affiliates.
Item 9.01 Financial Statements and Exhibits.
Regulation S-K Number |
Document | |
99.1 | Press release dated March 5, 2019 |
2 |
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.
NEXIEN BIOPHARMA, INC.
/s/: Alex Wasyl | |
Alex Wasyl, Chief Executive Officer March 5, 2019 |
3 |
EXHIBIT INDEX
Regulation S-K Number |
Document | |
99.1 | Press release dated March 5, 2019 |
4 |
Nexien BioPharma Announces Acceptance of Patent Application No. 238946 by Israeli Patent Office
—
Patent covers use of cannabinoids and terpenes for treatment of
organophosphate and carbamate toxicity —
Denver, CO, March 5, 2019 – Nexien BioPharma, Inc. (“Nexien” or the “Company”) (OTCQB: NXEN), a next generation biopharmaceutical company focused on research, development and commercialization of novel FDA-compliant cannabinoid pharmaceuticals and related drug delivery systems, today announced that its patent application No. 238946 for “Use of Cannabinoids and Terpenes for Treatment of Organophosphate and Carbamate Toxicity” has been accepted by the Israeli Patent Office. This application relates to pharmaceutical formulation compositions and their method of use in which isolated cannabinoid receptor modulators are optionally combined with terpene blends in a pharmaceutically acceptable carrier to treat or prevent disorders caused by exposure to an organophosphate or carbamate acetylcholinesterase inhibitor.
The endocannabinoid system and other physiological systems can potentially mitigate the effects of organophosphate and carbamate toxicity when treated with medicaments affecting these systems in a time and dose-dependent format.
Nexien’s unique process for treating symptoms incorporates a composition comprising tetrahydrocannabinol and cannabidiol formulated for administration by an oral, nasal, buccal, sublingual, parenteral, or any combination thereof.
According to the Notification of Acceptance issued by the Israel Patent Office, examination of the application is completed and the application has been accepted. Pursuant to several administrative procedures, it is anticipated that a patent could transition from accepted to granted in the coming months.
Alex Wasyl, Nexien’s Chief Executive Officer, stated, “Clinical investigation of advanced cannabinoid drug formulations and delivery systems could allow for significant advantages when compared with existing standard of care options for organophosphate and carbamate nerve agent exposure and resultant neurological and systemic toxicity. As bio-warfare becomes an increasing concern around the world, cannabinoid drug formulations could be a viable stand-alone or adjunct treatment option to provide patients with fewer side effects and thus an accelerated return to full functionality, whether soldiers or civilians.”
About Organophosphate and Carbamate Toxicity
Organophosphate and carbamate compounds are typically used as insecticides, pesticides, petroleum additives and petrochemicals. Organophosphate and carbamate have also been developed for use as chemical warfare nerve agents, such as Sarin. While some of these compounds are banned in developed countries, they are mostly inexpensive and accessible, especially in poorer countries. It is estimated that at least 750,000 cases of organophosphate poisoning occur every year with an estimated 300,000 fatalities a year world-wide.
About Nexien BioPharma, Inc.
Nexien BioPharma is a US-based pharmaceutical company engaged in the formulation, development and commercialization of cannabinoid-based pharmaceuticals in accordance with U.S. Food and Drug Administration (“FDA”) pre-clinical and clinical pathways, to address a broad range of medical conditions and disorders. Nexien BioPharma website: www.nexienbiopharma.com.
Forward Looking Statements
Nexien Disclosure Notice: This press release may contain “forward-looking statements, which are deemed to be any statements made by or on behalf of Nexien BioPharma that are not statements of historical facts. These statements reflect current beliefs, and a number of important factors could cause actual results to differ materially from those expressed in this release, including the factors set forth in “Risk Factors” in our most recent Form 10-K filed with the Securities and Exchange Commission (SEC) and subsequent filings with the SEC. Readers are cautioned not to place reliance on these forward-looking statements, which are valid only as of the date they were made. Nexien BioPharma undertakes no obligation to update or revise any forward-looking statements to reflect new information or the occurrence of unanticipated events or otherwise, except as expressly required by law.
Contacts
Nexien BioPharma, Inc.
info@nexienbiopharma.com
The Equity Group
Kalle Ahl, CFA
(212) 836-9614
kahl@equityny.com
Devin Sullivan
(212) 836-9608
dsullivan@equityny.com