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): June 27, 2020
AYTU BIOSCIENCE, INC.
(Exact
name of registrant as specified in its charter)
Delaware
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001-38247
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47-0883144
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(State
or other jurisdiction of incorporation)
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(Commission
File Number)
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(IRS
Employer Identification No.)
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373 Inverness Parkway, Suite 206
Englewood, CO 80112
(Address
of principal executive offices, including Zip Code)
Registrant’s
telephone number, including area code: (720) 437-6580
N/A
(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:
Title of each class
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Trading Symbol(s)
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Name of each exchange on which registered
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Common
Stock, par value $0.0001 per share
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AYTU
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The
NASDAQ Stock Market LLC
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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 7.01 Regulation FD Disclosure.
On June 27, 2020, Aytu BioScience, Inc. (the “Company”)
and Biolidics, Limited (“Biolidics”) signed a letter of
intent to, among other things, document the parties’ mutual
intention to enter into a joint development agreement (the
“Joint Development Agreement”) in order to advance the
development of and, if successful, commercialize a new SARS-CoV-2
diagnostic test (the "Proposed Collaboration"). The Company and
Biolidics are in the process of negotiating the definitive terms of
this Proposed Collaboration. The Company and Biolidics believe a
next generation SARS-CoV-2 test may address an important clinical
need as the 2019 Novel Coronavirus (“SARS-CoV-2
coronavirus” or “COVID-19”) health crisis
continues to unfold and the needs associated with patient testing
continue to evolve. Stockholders are reminded that there can be no
assurance the Company will enter into a Joint Development Agreement
with Biolidics for the Proposed Collaboration or that a new
SARS-CoV-2 diagnostic test will be successfully developed. The
Company will make the appropriate announcement(s) if and when there
are further material developments relating to the Proposed
Collaboration.
As previously announced, the Company also has a distribution
agreement in place with L.B Resources, Limited (L.B. Resources) and
is sourcing an FDA Emergency Use Authorized SARS-CoV-2 IgG/IgM
antibody test kits (“Orient Gene Test Kit(s)”)
manufactured by Zhejiang Orient Gene Biotech, Limited
(“Orient Gene”). The Orient Gene Test Kits received
Emergency Use Authorization (“EUA) from the U.S. Food and
Drug Administration (“FDA”) on May 29, 2020 following
the completion of the FDA’s commissioning of an independent
validation, which was conducted by the National Cancer Institute.
This independent laboratory evaluation demonstrated high
sensitivity and specificity of the test. Virtually all antibody
test kits in the Company’s warehouse and those tests that
have been sold to date have been sourced from Orient Gene. Through
its relationship with L.B. Resources in sourcing the Orient Gene
Test Kits, the Company believes it has access to adequate supply of
these FDA EUA Orient Gene Test Kits now and expects to have supply
as needed in the future.
Accordingly, and in connection with the planned Joint Development
Agreement, the Company and Biolidics have mutually agreed to
terminate their distribution agreement with effect from June 27,
2020. Each party shall release the other party of all the
obligations and duties under the Agreement, and all monies paid by
the Company to Biolidics for inventory orders placed but not
received will be returned. This termination does not materially
affect the Company’s supply of test kits. Also, in connection
with the planned Joint Development Agreement, Biolidics has begun
the process to voluntarily withdraw its application to the US FDA
for EUA pursuant to the FDA Serology Test Policy.
Forward-Looking Statement
This current report on Form 8-K includes forward-looking statements
within the meaning of Section 27A of the Securities Act of 1933, as
amended, and Section 21E of the Securities Exchange Act of 1934, or
the Exchange Act. All statements other than statements of
historical facts contained in this presentation, are
forward-looking statements. Forward-looking statements are
generally written in the future tense and/or are preceded by words
such as ''may,'' ''will,'' ''should,'' ''forecast,'' ''could,''
''expect,'' ''suggest,'' ''believe,'' ''estimate,'' ''continue,''
''anticipate,'' ''intend,'' ''plan,'' or similar words, or the
negatives of such terms or other variations on such terms or
comparable terminology. These statements are just predictions and
are subject to risks and uncertainties that could cause the actual
events or results to differ materially. These risks and
uncertainties include, among others: (i) whether negotiations
between us and Biolidics will be successful and result in the entry
into a Joint Development Agreement for the development of a new
SARS-CoV-2 diagnostic test, (ii) the ability to successfully
develop and commercialize a new SARS-CoV-2 diagnostic test even if
we are able to enter into a Joint Development Agreement with
Biolidics, market and consumer acceptance of any new SARS-CoV-2
diagnostic test developed if any, if we enter into a Joint
Development Agreement with Biolidics, (iii) our ability to obtain
FDA clearance for a new SARS-CoV-2 diagnostic test if it is
developed, (iv) our ability to successfully market and sell any of
our COVID-19 Rapid Test kits, whether supplied by L.B Resources or
Biolidics (the “COVID-19 Rapid Test Kits”), as a result
of increased scrutiny and media attention around the accuracy of
serology tests in the detection of SARS-CoV-2 coronavirus, (v) the
adequacy of our supply of COVID-19 Rapid Test Kits to meet future
demand, or (vi) our ability to enforce our exclusive U.S.
distribution agreement with Orient Gene and our ability to obtain
future Orient Gene Test Kits from Orient Gene. We also refer you to
the risks described in ''Risk Factors'' in Part I, Item 1A of our
Annual Report on Form 10-K and in the other reports and documents
we file with the Securities and Exchange Commission from time to
time.
In accordance with General Instruction B.2 of Form 8-K, the
information under this Item 7.01 shall not be deemed to be
“filed” for purposes of Section 18 of the Securities
Exchange Act of 1934, as amended (the “Exchange Act”),
nor shall such information be deemed incorporated by reference in
any filing under the Securities Act of 1933, as amended, or the
Exchange Act, except as shall be expressly set forth by specific
reference in such filing.
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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AYTU
BIOSCIENCE, INC.
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Date:
June 29, 2020
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By:
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/s/
Joshua R. Disbrow
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Joshua
R. Disbrow
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Chief
Executive Officer
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