<SEC-DOCUMENT>0001654954-20-002956.txt : 20200323
<SEC-HEADER>0001654954-20-002956.hdr.sgml : 20200323
<ACCEPTANCE-DATETIME>20200323080201
ACCESSION NUMBER:		0001654954-20-002956
CONFORMED SUBMISSION TYPE:	8-K
PUBLIC DOCUMENT COUNT:		2
CONFORMED PERIOD OF REPORT:	20200323
ITEM INFORMATION:		Other Events
ITEM INFORMATION:		Financial Statements and Exhibits
FILED AS OF DATE:		20200323
DATE AS OF CHANGE:		20200323

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:		20733634

	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>FORM 8-K
<TEXT>
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<font style="font-weight: bold; font-family: Times New Roman; font-size: 13px">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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<font style="font-family: Times New Roman; font-size: 13px">&#xA0;</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):&#xA0;<font style="font-weight: bold">March 23, 2020</font></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-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">
Delaware</font></div>
</td>
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<div><font style="font-family: Times New Roman; font-size: 13px">&#xA0;</font></div>
</td>
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<font style="font-weight: bold; font-family: Times New Roman; font-size: 13px">
001-38247</font></div>
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<div><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">
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
File Number)</font></div>
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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">&#xA0;</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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&#xA0;</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>
<div style="text-align: left; margin-left: 24px; margin-right: 0px; text-indent: -24px">
<font style="font-family: Times New Roman; font-size: 13px">&#xA0;</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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<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<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>
</td>
</tr></table>
</div>
<div style="text-align: left; margin-left: 24px; margin-right: 0px; text-indent: -24px">
<font style="font-family: Times New Roman; font-size: 13px">&#xA0;</font></div>
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<table cellpadding="0" cellspacing="0" style="text-align: left; width: 100%; font-family: Times New Roman; font-size: 13px; margin: 0px auto 0px 0px;">
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<td style="vertical-align: top; width: 2%;">
<div style="text-align: left; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-size: 13px">&#x2610;</font></div>
</td>
<td style="vertical-align: top; width: 98%;">
<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>
</td>
</tr></table>
</div>
<div style="text-align: left; margin-left: 24px; margin-right: 0px; text-indent: -24px">
<font style="font-family: Times New Roman; font-size: 13px">&#xA0;</font></div>
<div style="text-align: left">
<table cellpadding="0" cellspacing="0" style="text-align: left; width: 100%; font-family: Times New Roman; font-size: 13px; margin: 0px auto 0px 0px;">
<tr>
<td style="vertical-align: top; width: 2%;">
<div style="text-align: left; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-size: 13px">&#x2610;</font></div>
</td>
<td style="vertical-align: top; width: 98%;">
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<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>
</td>
</tr></table>
</div>
<div style="text-align: left; margin-left: 24px; margin-right: 0px; text-indent: -24px">
<font style="font-family: Times New Roman; font-size: 13px">&#xA0;</font></div>
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<table cellpadding="0" cellspacing="0" style="text-align: left; width: 100%; font-family: Times New Roman; font-size: 13px; margin: 0px auto 0px 0px;">
<tr>
<td style="vertical-align: top; width: 2%;">
<div style="text-align: left; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-size: 13px">&#x2610;</font></div>
</td>
<td style="vertical-align: top; width: 98%;">
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<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>
</td>
</tr></table>
</div>
<div style="text-align: left; margin-left: 24px; margin-right: 0px; text-indent: -24px">
<font style="font-family: Times New Roman; font-size: 13px">&#xA0;</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">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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<tr style="background-color: #ffffff">
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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">
Title of each class</font></div>
</td>
<td style="vertical-align: bottom; width: 1%">
<div><font style="font-family: Times New Roman; font-size: 13px">&#xA0;</font></div>
</td>
<td style="vertical-align: bottom; width: 28%; border-bottom: 2px solid rgb(0, 0, 0);">
<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>
</td>
<td style="vertical-align: bottom; width: 1%">
<div><font style="font-family: Times New Roman; font-size: 13px">&#xA0;</font></div>
</td>
<td style="vertical-align: bottom; width: 35%; border-bottom: 2px solid rgb(0, 0, 0);">
<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>
</td>
</tr><tr style="background-color: #cceeff">
<td style="vertical-align: top; width: 34%">
<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>
</td>
<td style="vertical-align: top; width: 28%">
<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">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: left; 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 id="ftr">
<div style="text-align: left; width: 100%"><font style="font-family: Times New Roman; font-size: 11px">&#xA0;</font></div>
</div>
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<div id="hdr">
<div style="text-align: right; width: 100%"><font style="font-family: Times New Roman; font-size: 11px">&#xA0;</font></div>
</div>
</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-weight: bold; font-family: Times New Roman; font-size: 13px">
Item 8.01 Other Events</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: 48px">
<font style="font-family: Times New Roman; font-size: 13px">On
March 23, 2020, Aytu BioScience, Inc. (the &#x201C;Company"),
reported that it has received confirmation from the U.S. Food and
Drug Administration (FDA) that the company may begin distribution
of its Coronavirus Disease 2019 (&#x201C;COVID-2019&#x201D;) IgG/IgM
Rapid Test throughout the United States. The COVID-19 IgG/IgM Rapid
Test is intended for professional use and delivers results between
2 and 10 minutes at the point-of-care.</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: 48px">
<font style="font-family: Times New Roman; font-size: 13px">In
addition, the Company expects delivery of its first shipment of
100,000 tests this week. The Company has been in discussions with
healthcare distributors, healthcare institutions, medical
practices, and government agencies and is working quickly to begin
distribution into the U.S. healthcare supply chain.</font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<br>
</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">Item
9.01 Financial Statements and Exhibits.</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="margin-left: 12px; display: table">
<div style="display: table-row">
<div style="text-align: left; display: table-cell; width: 12px">
<font style="font-family: Times New Roman; font-size: 13px">(d)</font></div>
<div style="text-align: justify; display: table-cell"><font style="font-family: Times New Roman; font-size: 13px">The following
exhibit is being filed herewith:</font></div>
</div>
</div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 10">&#xA0;</font>
<font style="font-family: Times New Roman; font-size: 13px"><br>
</font></div>
<div style="margin-left: 0px; margin-right: 0px; text-indent: 0px">
<div style="text-align: left; padding-top: 0px; padding-bottom: 0px; margin: 0px;">
<table cellpadding="0" cellspacing="0" style="text-align: left; width: 100%; font-family: Times New Roman; font-size: 13px; margin: 0px auto 0px 0px;">
<tr>
<td style="vertical-align: top; width: 5%; border-bottom: 2px solid rgb(0, 0, 0);">
<font style="font-weight: bold; font-family: Times New Roman; font-size: 13px">Exhibit</font></td>
<td style="width: 1%;">
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<font style="font-weight: bold; font-family: Times New Roman; font-size: 13px">Description</font></td>
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<font style="font-family: Times New Roman; font-size: 13px"><a href="aytu_ex991.htm">99.1</a><br></font></div>
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<div><font><font><font style="font-family: Times New Roman; font-size: 13px">Press
Release dated March 23, 2020</font>&#xA0;</font></font></div>
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SIGNATURES</font></div>
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<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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<font style="font-family: Times New Roman; font-size: 13px">Date:
March 23, 2020</font></div>
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<font style="font-family: Times New Roman; font-size: 13px">/s/
Joshua R. Disbrow</font></div>
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<font style="font-family: Times New Roman; font-size: 13px">Joshua
R. Disbrow</font></div>
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<font style="font-family: Times New Roman; font-size: 13px">Chief
Executive Officer</font></div>
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<TYPE>EX-99.1
<SEQUENCE>2
<FILENAME>aytu_ex991.htm
<DESCRIPTION>PRESS RELEASE
<TEXT>
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&#xA0; <font style="font-family: Times New Roman; font-size: 13px"><font style="font-weight: bold">Exhibit 99.1</font><br></font></div>
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<font style="color: #000000; font-weight: bold; font-family: Times New Roman; font-size: 16px">
<font style="font-size: 13px">Aytu BioScience Submits Notice of
Commercialization to the FDA, Allowing for Company&#x2019;s
Distribution of its 2-10 Minute COVID-19 IgG/IgM Point-of-Care
Rapid Test</font></font></div>
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<font style="font-style: italic; font-family: Times New Roman; font-size: 13px">
Commercial Distribution of First 100,000 Tests to Commence Upon
Receipt of Inbound Product Shipment</font></div>
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<font style="font-family: Times New Roman; font-size: 13px">ENGLEWOOD,
CO / ACCESSWIRE / March 23, 2020 / Aytu BioScience, Inc. (NASDAQ:
AYTU), a specialty pharmaceutical company focused on
commercializing novel products that address significant patient
needs <a name="_Hlk35771999">
<!--anchor--></a>announced today that it has received confirmation
from the U.S. Food and Drug Administration (FDA) that the company
may begin distribution of its Coronavirus Disease 2019
(&#x201C;COVID-2019&#x201D;) IgG/IgM Rapid Test throughout the United
States. The COVID-19 IgG/IgM Rapid Test is intended for
professional use and delivers results between 2 and 10 minutes at
the point-of-care<font style="font-style: italic">.</font></font></div>
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<font style="font-family: Times New Roman; font-size: 13px">Aytu
expects delivery of its first shipment of 100,000 tests this week.
The initial product shipment is in transit from the manufacturer
and, upon receipt, will undergo FDA and U.S. Customs and Border
Protection (CBP) clearance processes. The test kits will then be
repackaged to comply with FDA&#x2019;s labeling requirements under
the most recent coronavirus guidance for serological test kit
manufacturers. The Company has been in discussions with healthcare
distributors, healthcare institutions, medical practices, and
government agencies and is working rapidly to distribute the test
into the U.S. healthcare supply chain.</font></div>
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<font style="font-family: Times New Roman; font-size: 13px">Josh
Disbrow, Chief Executive Officer of Aytu BioScience, commented,
&#x201C;We are moving as quickly as we can to bring the COVID-19
IgG/IgM Rapid Test to the U.S. professional medical community. With
product now in transit to our warehouse in Colorado we&#x2019;re
optimistic that we can have test kits ready for sale in the very
near term. In the two short weeks since signing our distribution
agreement, we have ordered our first 100,000 tests and have
received confirmation from FDA that we may begin distribution. We
are optimistic that we&#x2019;re now just days away from placing
these COVID-19 test kits into the hands of healthcare
professionals.&#x201D;</font></div>
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<font style="font-family: Times New Roman; font-size: 13px">The
COVID-19 IgG/IgM Rapid 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 and is CE marked.</font></div>
<div><font style="font-family: Times New Roman; font-size: 10">&#xA0;</font></div>
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<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 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 113 patient clinical
trial 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></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">
Forward-Looking Statement</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">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 completion of the registered direct offering, the satisfaction
of customary closing conditions related to the registered direct
offering and the intended use of net proceeds from the registered
direct offering, the regulatory and commercial risks associated
with introducing the COVID-19 Rapid Test, 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 of our product candidates, the anticipated
start dates, durations and completion dates, as well as the
potential future results, of our ongoing and future clinical
trials, the anticipated designs of our future clinical trials,
anticipated future regulatory submissions and events, our
anticipated future cash position and future events under our
current and potential future collaboration. 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>
<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">
Contact for Media and Investors:</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>
<div style="text-align: left; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px">Hayden
IR</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">(646)
755-7412</font></div>
<div style="text-align: left; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="text-decoration: underline; color: #23527C; font-size: 13px; font-family: Times New Roman">
james@haydenir.com</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; color: #000000; font-family: Times New Roman; font-size: 13px">
Contact for COVID-19 IgG/IgM Rapid Test-Related
Inquiries:</font></div>
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<font style="text-decoration: underline; color: #0563C1; font-family: Times New Roman; font-size: 13px">
COVID-19@aytubio.com</font></div>
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