Current Report Filing (8-k)
21 March 2018 - 12:02AM
Edgar (US Regulatory)
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 15, 2018
VITALITY
BIOPHARMA, INC
(Exact
name of registrant as specified in its charter)
Nevada
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000-53832
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75-3268988
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(State
or other jurisdiction
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(Commission
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(I.R.S.
Employer
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of
incorporation)
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File
Number)
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Identification
No.)
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1901
Avenue of the Stars, 2
nd
Floor
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Los
Angeles, California
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90067
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(Address
of principal executive offices)
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(Zip
Code)
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Registrant’s
telephone number, including area code: (
530) 231-7800
Not
Applicable
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(Former
name or former address, if changed since last report.)
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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):
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Written
communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
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Soliciting
material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
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Pre-commencement
communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
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Pre-commencement
communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
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Item
8.01 Other Events.
Management
Letter to Shareholders
On
March 16, 2018, the Company’s CEO sent a letter, attached hereto as Exhibit 19.1, to all shareholders of record, which described
the Company’s current research and development efforts (the “Shareholder Letter”). In addition, the Company
issued a press release, attached hereto as Exhibit 19.2 (the “Press Release”), which described the Shareholder Letter
and included a link to the Shareholder Letter on the Company’s web site.
Letter
from the FDA’s Office of Orphan Products Development
In
a letter received March 15, 2018, from the U.S. Food and Drug Administration’s (“FDA’s”) Office of Orphan
Products Development (“OOPD”), attached hereto as Exhibit 20.1, the OOPD informed the Company that its request for
orphan drug designation was unable to be granted based on the Company’s existing submission. The FDA recently announced
that it no longer intends to grant orphan drug designation to drugs for pediatric subpopulations of common diseases and also cited
within its letter to the Company (the “OOPD Letter”) clinical data published in 2017 that suggests the overall prevalence
in the United States of ulcerative colitis and pediatric ulcerative colitis may exceed 200,000, which is the upper limit to be
considered an orphan condition. Although the company possesses additional preclinical and clinical data on use of cannabinoids
and its drug products for treatment of colitis, which the Company expects could fulfill the OOPD’s separate requests for
additional scientific data, the Company does not intend to further pursue orphan designation for treatment of this disease given
recent FDA policy changes and the updated clinical data that suggests a high prevalence of ulcerative colitis and pediatric ulcerative
colitis in the United States.
The
foregoing descriptions of the Shareholder Letter and the OOPD Letter do not purport to be complete and are qualified in their
entirety by reference to the full text of each document. Copies of the Shareholder Letter and the OOPD Letter are attached to
this Current Report on Form 8-K as Exhibit 19.1 and Exhibit 20.1, respectively, and each is incorporated herein by reference.
The
information set forth under Item 8.01 of this Current Report on Form 8-K is furnished and shall not be deemed “filed”
for purposes of Section 18 of the Securities Exchange Act of 1934, and shall not be deemed incorporated by reference in any filing
with the Securities and Exchange Commission under the Securities Exchange Act of 1934 or the Securities Act of 1933, whether made
before or after the date hereof and irrespective of any general incorporation by reference language in any filing.
Portions
of this report constitute “forward-looking statements” defined by federal law. Although the Company believes any such
statements are based on reasonable assumptions, there is no assurance that the actual outcomes will not be materially different.
Any such statements are made in reliance on the “safe harbor” protections provided under the Private Securities Litigation
Reform Act of 1995. Additional information about issues that could lead to material changes in the Company’s performance
is contained in the Company’s filings with the Securities and Exchange Commission and may be accessed at
www.sec.gov
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Item
9.01 Financial Statements and Exhibits.
(d)
Exhibits.
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.
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VITALITY BIOPHARMA, INC.
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Dated:
March 20, 2018
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By:
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/s/
Robert Brooke
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Name:
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Robert
Brooke
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Title:
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Chief
Executive Officer
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