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): July 14, 2020

 

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))

 

Securities registered pursuant to Section 12(b) of the Act: None

 

Title of each class   Trading symbol(s)   Name of each exchange on which registered
         

 

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 July 14, 2020, Nexien BioPharma, Inc. issued a press release about the Company being issued a patent from the United States Patent and Trademark Office covering the methods and compositions for treating non-dystrophic myotonia and myotonic dystrophies types 1 and 2. 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 July 14, 2020

 

 

 

 

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/: Richard Greenberg  
Richard Greenberg, Interim Chief Executive Officer  
July 14, 2020  

 

EXHIBIT INDEX

 

Regulation

S-K Number

  Document
99.1   Press release dated July 14, 2020

 

 

 

 

Exhibit 99.1

 

 

Nexien BioPharma, Inc. has been Issued a U.S. Patent for the Methods and Compositions for Treating Non-Dystrophic Myotonia and Myotonic Dystrophies Types 1 and 2

 

The patent relates to the administration of a specific composition comprised of cannabinoids to a patient

 

Denver, Colorado, July 14, 2020 - The United States Patent and Trademark Office (USPTO) has issued a patent to Nexien BioPharma, Inc. (Stock Symbol: NXEN) (“Nexien”). The patent US10,702,495, issued on July 7, 2020, covers methods and compositions for treating patients having non-dystrophic myotonia and myotonic dystrophies (DM Type 1 and DM Type 2) with oral formulations of cannabidiol and tetrahydrocannabinol.

 

In commenting on the issuance of the patent by the USPTO, Richard Greenberg, CEO and Chairman of Nexien stated, “We’re excited regarding the issuance of the patent covering the use of cannabinoids and/or terpenes to the treatment of myotonia and DM Type 1 and DM Type 2. We believe that a cannabinoid-based formulation could be beneficial in treating the debilitating symptoms of myotonia and DM Type 1 and DM Type 2.” Greenberg also stated “The issuance of this patent provides a green-light to Nexien to further our previously funded pre-clinical investigation regarding the use of cannabinoids for these disorders conducted by Professor Benedikt Schoser, world-renowned myotonic dystrophy, and myotonia expert, at the University of Munich. We also believe that the issuance of this patent enhances Nexien’s ability to attract a financial or industry strategic partner to help further the Company’s research.”

 

About Myotonia and Myotonic Dystrophies (DM)

 

Myotonia refers to a neuromuscular condition in which the relaxation of a muscle is impaired and can affect any muscle group of the body. Because a repeated effort is required to relax the muscle, individuals with myotonia may have massive trouble with normal daily activities including releasing their grip on objects (e.g., knife, fork, and spoon), and having difficulty rising from a seated position, or beginning to walk. Patients suffering from myotonia often walk with a stiff, slow, and awkward gait.

 

 
 

 

DM is an autosomal dominant transmitted genetic disorder that affects all parts of the human body but predominantly affects muscular function. Symptoms include gradually increased muscle loss and weakness. There is currently no cure for DM and various drugs are often prescribed to manage symptoms without great success. An estimated 31.5 in 100,000 people are affected by DM1 in the United States alone.

 

Based on the current patient population, it is anticipated that the annual market to treat patients with DM Type 1 and DM Type 2 could range between $500 million to $1 billion.

 

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.

 

Company Contact:  
Nexien BioPharma, Inc.  
Richard Greenberg, CEO and Chairman  
Website www.nexienbiopharma.com  
Email info@nexienbiopharma.com