<SEC-DOCUMENT>0001654954-20-004762.txt : 20200501
<SEC-HEADER>0001654954-20-004762.hdr.sgml : 20200501
<ACCEPTANCE-DATETIME>20200501080032
ACCESSION NUMBER:		0001654954-20-004762
CONFORMED SUBMISSION TYPE:	8-K
PUBLIC DOCUMENT COUNT:		2
CONFORMED PERIOD OF REPORT:	20200501
ITEM INFORMATION:		Regulation FD Disclosure
ITEM INFORMATION:		Financial Statements and Exhibits
FILED AS OF DATE:		20200501
DATE AS OF CHANGE:		20200501

FILER:

	COMPANY DATA:	
		COMPANY CONFORMED NAME:			AYTU BIOSCIENCE, INC
		CENTRAL INDEX KEY:			0001385818
		STANDARD INDUSTRIAL CLASSIFICATION:	PHARMACEUTICAL PREPARATIONS [2834]
		IRS NUMBER:				470883144
		STATE OF INCORPORATION:			DE
		FISCAL YEAR END:			0630

	FILING VALUES:
		FORM TYPE:		8-K
		SEC ACT:		1934 Act
		SEC FILE NUMBER:	001-38247
		FILM NUMBER:		20838390

	BUSINESS ADDRESS:	
		STREET 1:		373 INVERNESS PARKWAY
		STREET 2:		SUITE 206
		CITY:			ENGLEWOOD
		STATE:			CO
		ZIP:			80112
		BUSINESS PHONE:		(720) 437-6580

	MAIL ADDRESS:	
		STREET 1:		373 INVERNESS PARKWAY
		STREET 2:		SUITE 206
		CITY:			ENGLEWOOD
		STATE:			CO
		ZIP:			80112

	FORMER COMPANY:	
		FORMER CONFORMED NAME:	AYTU BIOSCIENCE, INC.
		DATE OF NAME CHANGE:	20150609

	FORMER COMPANY:	
		FORMER CONFORMED NAME:	Rosewind CORP
		DATE OF NAME CHANGE:	20070110
</SEC-HEADER>
<DOCUMENT>
<TYPE>8-K
<SEQUENCE>1
<FILENAME>aytu_8k.htm
<DESCRIPTION>CURRENT REPORT
<TEXT>
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UNITED STATES</font></div>
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SECURITIES AND EXCHANGE COMMISSION</font></div>
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Washington, D.C. 20549</font></div>
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FORM 8-K</font></div>
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CURRENT REPORT</font></div>
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Pursuant to Section 13 or 15(d) of the Securities Exchange Act of
1934</font></div>
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<font style="font-family: Times New Roman; font-size: 13px">Date of
Report (Date of earliest event reported):<font style="font-weight: bold; color: #000000; font-family: Times New Roman; font-size: 13px">&#xA0;</font><font style="font-weight: bold; color: #000000">May
1</font><font style="font-weight: bold">, 2020</font></font></div>
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<font style="font-family: Times New Roman; font-size: 13px">&#xA0;</font></div>
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<font style="font-weight: bold; font-family: Times New Roman; font-size: 13px">
AYTU BIOSCIENCE, INC.</font></div>
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<font style="font-family: Times New Roman; font-size: 13px">(Exact
name of registrant as specified in its charter)</font></div>
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<font style="font-weight: bold; font-family: Times New Roman; font-size: 13px">
Delaware</font></div>
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001-38247</font></div>
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<font style="font-weight: bold; font-family: Times New Roman; font-size: 13px">
47-0883144</font></div>
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<font style="font-family: Times New Roman; font-size: 13px">(State
or other jurisdictionof incorporation)</font></div>
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<font style="font-family: Times New Roman; font-size: 13px">(Commission
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<font style="font-family: Times New Roman; font-size: 13px">(IRS
Employer Identification No.)</font></div>
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<font style="font-weight: bold; font-family: Times New Roman; font-size: 13px">
373 Inverness Parkway, Suite 206</font></div>
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<font style="font-weight: bold; font-family: Times New Roman; font-size: 13px">
Englewood, CO 80112</font></div>
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<font style="font-family: Times New Roman; font-size: 13px">(Address
of principal executive offices, including Zip Code)</font></div>
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<font style="font-family: Times New Roman; font-size: 13px">Registrant&#x2019;s
telephone number, including area code: <font style="font-weight: bold">(720) 437-6580</font></font></div>
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N/A</font></div>
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<font style="font-family: Times New Roman; font-size: 13px">(Former
name or former address, if changed since last report)</font></div>
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<font style="font-family: Times New Roman; font-size: 13px">&#xA0;</font></div>
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<font style="font-family: Times New Roman; font-size: 13px">Check
the appropriate box below if the Form&#xA0;8-K filing is intended
to simultaneously satisfy the filing obligation of the registrant
under any of the following provisions:</font></div>
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<font style="font-family: Times New Roman; font-size: 13px">Written
communications pursuant to Rule&#xA0;425 under the Securities Act
(17 CFR 230.425)</font></div>
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<font style="font-size: 13px">&#x2610;</font></div>
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<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px">Soliciting
material pursuant to Rule&#xA0;14a-12 under the Exchange Act (17
CFR 240.14a-12)</font></div>
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<font style="font-family: Times New Roman; font-size: 13px">&#xA0;</font></div>
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<font style="font-size: 13px">&#x2610;</font></div>
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<font style="font-family: Times New Roman; font-size: 13px">Pre-commencement
communications pursuant to Rule&#xA0;14d-2(b) under the Exchange
Act (17 CFR 240.14d-2(b))</font></div>
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<div style="text-align: left; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-size: 13px">&#x2610;</font></div>
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<font style="font-family: Times New Roman; font-size: 13px">Pre-commencement
communications pursuant to Rule&#xA0;13e-4(c) under the Exchange
Act (17 CFR 240.13e-4(c))</font></div>
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<font style="font-family: Times New Roman; font-size: 13px">Securities
registered pursuant to Section 12(b) of the Act:</font></div>
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<font style="font-family: Times New Roman; font-size: 13px">&#xA0;</font></div>
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<font style="font-weight: bold; font-family: Times New Roman; font-size: 13px">
Title of each class</font></div>
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<div style="text-align: center; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-weight: bold; font-family: Times New Roman; font-size: 13px">
Trading Symbol(s)</font></div>
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<div><font style="font-family: Times New Roman; font-size: 13px">&#xA0;</font></div>
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<div style="text-align: center; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-weight: bold; font-family: Times New Roman; font-size: 13px">
Name of each exchange on which registered</font></div>
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<div style="text-align: center; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px">Common
Stock, par value $0.0001 per share</font></div>
</td>
<td style="vertical-align: top; width: 1%">
<div><font style="font-family: Times New Roman; font-size: 13px">&#xA0;</font></div>
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<div style="text-align: center; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px">AYTU</font></div>
</td>
<td style="vertical-align: top; width: 1%">
<div><font style="font-family: Times New Roman; font-size: 13px">&#xA0;</font></div>
</td>
<td style="vertical-align: top; width: 35%">
<div style="text-align: center; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px">The
NASDAQ Stock Market LLC</font></div>
</td>
</tr></table>
</div>
<div style="text-align: left; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px">&#xA0;</font></div>
<div style="text-align: left; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px">Indicate
by check mark whether the registrant is an emerging growth company
as defined in Rule 405 of the Securities Act of 1933 (&#xA7;230.405
of this chapter) or Rule 12b-2 of the Securities Exchange Act of
1934 (&#xA7;240.12b-2 of this chapter).&#xA0;</font></div>
<div style="text-align: left; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px">&#xA0;</font></div>
<div style="text-align: right; margin-left: 24px; margin-right: 0px; text-indent: -24px">
<font style="font-family: Times New Roman; font-size: 13px">Emerging growth
company <font>&#x2610;</font></font></div>
<div style="text-align: left; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px">&#xA0;</font></div>
<div style="text-align: left; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px">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. <font>&#x2610;</font></font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px">&#xA0;</font></div>
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</div>
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<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px">&#xA0;</font></div>
<div style="text-align: left; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px"><font style="font-size: 1px">
</font><font style="font-weight: bold">Item 7.01 Regulation FD
Disclosure</font></font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px">&#xA0;</font></div>
<div style="text-align: left; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px">On
April 30, 2020, Aytu BioScience, Inc. (the &#x201C;Company&#x201D;) a
specialty pharmaceutical company focused on commercializing novel
products that address significant patient needs announced today
that it has received confirmation of export approval for product
shipment by China&#x2019;s Ministry of Commerce for the
Company&#x2019;s COVID-19 IgG/IgM Rapid Test.</font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px">&#xA0;</font></div>
<div style="text-align: left; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-style: italic; color: #000000; font-family: Times New Roman; font-size: 13px">
Forward-Looking Statement</font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px">&#xA0;</font></div>
<div style="text-align: left; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="color: #000000; font-family: Times New Roman; font-size: 13px">
This press release 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: market and other conditions,
the regulatory and commercial risks associated with introducing the
COVID-19 Rapid Test, any delays in shipment that may impact our
ability to distribute the COVID-19 Rapid Test, any reputational
harm we may incur if there are delays in receiving the shipment of
the COVID-19 Rapid Test, our ability to enforce the exclusivity
provisions of the distribution agreement, the reliability of
serological testing in detecting COVID-19, shipping delays and
their impact on our ability to introduce the COVID-19 Rapid Test,
the ability of the COVID-19 Rapid Test to accurately and reliably
test for COVID-19, the manufacturer of the COVID-19 Rapid Test's
ability to manufacture such testing kits on a high volume scale,
manufacturing problems or delays related to the COVID-19 Rapid
Test, our ability to satisfy any labelling conditions or other FDA
or other regulatory conditions to sell the COVID-19 Rapid Test Kit,
the demand or lack thereof for the COVID-19 Rapid Test Kit, our
ability to obtain additional COVID-19 Rapid Tests to meet demand,
our ability to secure additional tests if the manufacture of the
COVID-19 Rapid Tests is unable to meet demand, the effects of the
business combination of Aytu and the Commercial Portfolio and the
recently completed merger ("Merger") with Innovus Pharmaceuticals,
including the combined company's future financial condition,
results of operations, strategy and plans, the ability of the
combined company to realize anticipated synergies in the timeframe
expected or at all, changes in capital markets and the ability of
the combined company to finance operations in the manner expected,
the diversion of management time on Merger-related issues and
integration of the Commercial Portfolio, the ultimate timing,
outcome and results of integrating the operations the Commercial
Portfolio and Innovus with Aytu's existing operations, risks
relating to gaining market acceptance of our products, obtaining or
maintaining reimbursement by third-party payors for our
prescription products, the potential future commercialization. We
also refer you to the risks described in ''Risk Factors'' in Part
I, Item 1A of the Company's 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.</font></div>
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<font style="font-weight: bold; font-family: Times New Roman; font-size: 13px">
Item 9.01 Financial Statements and Exhibits.</font></div>
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<font style="font-family: Times New Roman; font-size: 13px"><br>
</font></div>
<div style="text-align: justify; margin-left: 96px; margin-right: 0px; text-indent: -96px"><font style="color: #000000; font-size: 13px; font-family: Times New Roman">(d)
The following exhibit is being filed herewith:</font></div>
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</td>
<td style="vertical-align: top; width: 91%; border-bottom: 2px solid #000000">
<div style="text-align: left; margin-left: 0px; margin-right: 0px; text-indent: 0px"><font style="font-size: 11px"><font style="font-weight: bold; color: #000000; font-family: Times New Roman">Description</font></font></div>
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<div style="text-align: left; margin-left: 0px; margin-right: 0px; text-indent: 0px"><font style="color: rgb(0, 0, 0);"><a href="aytu_ex991.htm"><font style="font-size: 13px; font-family: Times New Roman;">99.1</font></a></font></div>
</td>
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<div style="text-align: left; margin-left: 0px; margin-right: 0px; text-indent: 0px"><font style="font-size: 13px; font-family: Times New Roman">Press Release dated
April 30, 2020</font></div>
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<div id="pn" style="text-align: center"><font style="font-family: Times New Roman; font-size: 13px">1</font></div>
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<font style="font-weight: bold; font-family: Times New Roman; font-size: 13px">
SIGNATURES</font></div>
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<font style="font-family: Times New Roman; font-size: 13px">&#xA0;</font></div>
<div style="text-align: left; margin-left: 0px; margin-right: 0px; text-indent: 36px">
<font style="font-family: Times New Roman; font-size: 13px">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.</font></div>
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<font style="font-weight: bold; font-family: Times New Roman; font-size: 13px">
AYTU BIOSCIENCE, INC.</font></div>
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<div style="text-align: left; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px">Date:
May 1, 2020</font></div>
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<font style="font-family: Times New Roman; font-size: 13px">By:</font></div>
</td>
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<div style="text-align: left; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px">/s/
Joshua R. Disbrow</font></div>
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<div style="text-align: left; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px">Joshua
R. Disbrow</font></div>
</td>
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<div><font style="font-family: Times New Roman; font-size: 13px">&#xA0;</font></div>
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<div><font style="font-family: Times New Roman; font-size: 13px">&#xA0;</font></div>
</td>
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<div style="text-align: left; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px">Chief
Executive Officer</font></div>
</td>
</tr></table>
</div>
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<div id="pn" style="text-align: center"><font style="font-family: Times New Roman; font-size: 13px">2</font></div>
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<DOCUMENT>
<TYPE>EX-99.1
<SEQUENCE>2
<FILENAME>aytu_ex991.htm
<DESCRIPTION>PRESS RELEASE
<TEXT>
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<div style="text-align: right"><font style="font-weight: bold; color: #000000; font-family: Times New Roman; font-size: 13px">
Exhibit 99.1</font></div>
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<font style="font-family: Times New Roman; font-size: 13px">&#xA0;</font></div>
<div style="text-align: center"><font style="color: #000000; font-weight: bold; font-family: Times New Roman; font-size: 16px">
Aytu BioScience Announces China Export Clearance of Company&#x2019;s
COVID-19 IgG/IgM Rapid Test</font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px">&#xA0;</font></div>
<div style="text-align: center"><font style="font-weight: bold; color: #000000; font-family: Times New Roman; font-size: 13px">
500,000 Rapid Tests Cleared for Shipment to Company&#x2019;s
Warehouse</font></div>
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<font style="font-family: Times New Roman; font-size: 13px">&#xA0;</font></div>
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<font style="font-family: Times New Roman; font-size: 13px">ENGLEWOOD,
CO / ACCESSWIRE / April 30, 2020 / Aytu BioScience, Inc. (NASDAQ:
AYTU) (the &#x201C;Company&#x201D;), a specialty pharmaceutical
company focused on commercializing novel products that address
significant patient needs announced today that it has received
confirmation of export approval for product shipment by
China&#x2019;s Ministry of Commerce for the Company&#x2019;s COVID-19
IgG/IgM Rapid Test.</font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px">&#xA0;</font></div>
<div style="text-align: left; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px">Josh
Disbrow, Chief Executive Officer of Aytu BioScience, commented,
&#x201C;The backlog of medical products being exported from China
created a shipment delay, but Aytu&#x2019;s next 500,000 rapid tests
have now been cleared for shipment to the U.S. This export
clearance from China, along with the additional supply we have
secured through our new relationship with Biolidics, gives us great
confidence in our supply chain and ability to provide these needed
test kits to the U.S. medical community. Our shipments remain on
track for delivery and, upon receipt, will be distributed to U.S.
customers.&#x201D;</font></div>
<div><font style="font-family: Times New Roman; font-size: 10">&#xA0;</font></div>
<div style="text-align: left; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-weight: bold; font-family: Times New Roman; font-size: 13px">
About Aytu BioScience, Inc.</font></div>
<div><font style="font-family: Times New Roman; font-size: 10">&#xA0;</font></div>
<div style="text-align: left; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px">Aytu
BioScience, Inc. is a commercial-stage specialty pharmaceutical
company focused on commercializing novel products that address
significant patient needs. The Company currently markets a
portfolio of prescription products addressing large primary care
and pediatric markets. The primary care portfolio includes (i)
Natesto&#xAE;, the only FDA-approved nasal formulation of
testosterone for men with hypogonadism (low testosterone, or "Low
T"), (ii) ZolpiMist&#x2122;, the only FDA-approved oral spray
prescription sleep aid, and (iii) Tuzistra&#xAE; XR, the only
FDA-approved 12-hour codeine-based antitussive syrup. The pediatric
portfolio includes (i) AcipHex&#xAE; Sprinkle&#x2122;, a granule
formulation of rabeprazole sodium, a commonly prescribed proton
pump inhibitor; (ii) Cefaclor, a second-generation cephalosporin
antibiotic suspension; (iii) Karbinal&#xAE; ER, an extended-release
carbinoxamine (antihistamine) suspension indicated to treat
numerous allergic conditions; and (iv) Poly-Vi-Flor&#xAE; and
Tri-Vi-Flor&#xAE;, two complementary prescription fluoride-based
supplement product lines containing combinations of fluoride and
vitamins in various for infants and children with fluoride
deficiency. Aytu recently acquired exclusive U.S. distribution
rights to the COVID-19 IgG/IgM Rapid Test. This coronavirus test is
a solid phase immunochromatographic assay used in the rapid,
qualitative and differential detection of IgG and IgM antibodies to
the 2019 Novel Coronavirus in human whole blood, serum or plasma.
This point-of-care test has been validated in a 126 patient
clinical trial in China and has received CE marking.</font></div>
<div><font style="font-family: Times New Roman; font-size: 10">&#xA0;</font></div>
<div style="text-align: left; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px">Aytu
recently acquired Innovus Pharmaceuticals, a specialty
pharmaceutical company commercializing, licensing and developing
safe and effective consumer healthcare products designed to improve
men's and women's health and vitality. Innovus commercializes over
thirty-five consumer health products competing in large healthcare
categories including diabetes, men's health, sexual wellness and
respiratory health. The Innovus product portfolio is commercialized
through direct-to-consumer marketing channels utilizing the
Company's proprietary Beyond Human&#xAE; marketing and sales
platform.</font></div>
<div><font style="font-family: Times New Roman; font-size: 10">&#xA0;</font></div>
<div style="text-align: left; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px">Aytu's
strategy is to continue building its portfolio of
revenue-generating products, leveraging its focused commercial team
and expertise to build leading brands within large therapeutic
markets. For more information visit aytubio.com and visit
innovuspharma.com to learn about the Company's consumer healthcare
products.</font></div>
<div><font style="font-family: Times New Roman; font-size: 10">&#xA0;</font><font style="font-family: Times New Roman; font-size: 13px">&#xA0;</font><font style="font-family: Times New Roman; font-size: 10">&#xA0;</font></div>
<div style="text-align: left; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-weight: bold; color: #333333; font-family: Times New Roman; font-size: 13px">
C<font style="color: rgb(0, 0, 0);">ontact for Media and
Investors:</font></font></div>
<div><font style="font-family: Times New Roman; font-size: 10">&#xA0;</font></div>
<div style="text-align: left; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px;">James
Carbonara</font></div>
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<font style="font-family: Times New Roman; font-size: 13px;">Hayden
IR</font></div>
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<font style="font-family: Times New Roman; font-size: 13px;">(646)
755-7412</font></div>
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<font style="text-decoration: underline; font-size: 13px; font-family: Times New Roman;">
james@haydenir.com</font></div>
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