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 5, 2018
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 November 5, 2018, Nexien BioPharma, Inc. issued a press release about its investigation into the use of cannabinoid-based formulations for the treatment of patients suffering from Myotonic Dystrophy and Myotonia. A copy of the press release is included as Exhibit 99.1. 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.
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Regulation S-K Number |
Document | |
| 99.1 | Press release dated November 5, 2018 |
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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 November 5, 2018 |
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EXHIBIT INDEX
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Regulation S-K Number |
Document | |
| 99.1 | Press release dated November 5, 2018 |
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Nexien BioPharma Advances in Clinical Use of a Cannabinoid-Based
Formulation for the Treatment of Myotonic Dystrophies and Myotonia
Denver, Colorado, November 5, 2018 Nexien BioPharma Inc. (OTC QB: NXEN) (“Nexien” or the “Company”) announced that it was initiating an investigation into the use of cannabinoid-based formulations for the treatment of patients suffering from Myotonic Dystrophy (DM) and Myotonia.
Munich-based Dr. Benedikt Schoser, who joined Nexien as a scientific advisor in July , and myotonic dystrophy patient organizations, recently shared two questionnaires. One was in Germany and the other in the United States with both DM type 1 and DM type 2 patients. The purpose of the questionnaires was to determine patient experience with cannabinoids and if cannabinoids were used, to identify whether symptom relief occurred. Results of both questionnaires suggest further exploration is warranted. The detailed results are under review presently at a scientific medical journal.
Additional clinical observations will be summarized soon by Dr. Schoser. The patient group consists of patients suffering from non-dystrophic myotonia, and both types of myotonic dystrophies. If the summary indicates that cannabinoid-based formulations are supportive in relief of DM symptoms, Nexien will likely proceed with clinical studies in accordance with U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) protocols.
Earlier this year Nexien filed a utility patent application with the United States Patent and Trademark Office (USPTO) relating to the use of cannabinoids to treat myotonia, myotonic dystrophy, and other related dystrophies. That application is based on a previously-filed provisional patent application that was filed by the Company in 2017.
Alex Wasyl, Chief Executive Officer stated, “There is significant anecdotal evidence reinforced by the patient questionnaire results that the use of cannabinoids provides relief to many myotonia and myotonic dystrophy patients. This evidence resulted in our engagement of Dr. Schoser as a Nexien advisor in July. We are hopeful that Dr. Schoser´s summary of clinical observations in Germany will help support our work regarding the use of cannabinoid-based formulations for these diseases, and will enable Nexien to proceed with pre-clinical and clinical studies under FDA protocols.”
About Myotonia and Myotonic Dystrophies
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 significant trouble with normal daily activities, including releasing their grip on objects (i.e. 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 can affect 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.
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About Dr. Benedikt Schoser
Dr. Benedikt Schoser is the senior consultant neurologist and co-chair of the Friedrich-Baur Institute, Germany’s major national referral center for rare neuromuscular diseases. His clinical and research interests are in the field of multisystemic neuromuscular diseases, and metabolic and myotonic myopathies.
Dr. Schoser is an Associate Professor of Neurology at the Ludwig Maximilians University in Munich, Germany. Since 2010 he has also been the head of the Interdisciplinary Center for Neuromuscular Disorders at the University’s Munich campus. Dr. Schoser has authored and co-authored more than 200 articles in peer-reviewed journals and has contributed more than 20 chapters to books on neurology and muscle pathology.
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
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:
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Mark Lubchenco Director of Investor Relations Nexien BioPharma Inc. Tel. 1-303-495-7583 |
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| Email: | mlubchenco@nexienbiopharma.com |
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