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
31, 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 jurisdictionof 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 8.01 Other Events
On
April 1, 2020, Aytu BioScience, Inc. (the “Company”) a
specialty pharmaceutical company focused on commercializing novel
products that address significant patient needs announced today
that it has received its first Coronavirus Disease 2019
(“COVID-2019”) IgG/IgM Rapid Test shipment containing
100,000 tests from the manufacturer on March 31, 2020. The Company
is now in the process of relabeling the test kits to comply with
Food and Drug Administration (FDA) requirements relating to
labeling of COVID-19 serology test kits and expects to begin
filling current backorders and additional incoming orders shortly
thereafter.
Additionally,
the Company announced that it expects to receive another 500,000
rapid tests from the manufacturer in the next two to three weeks in
order to fulfill additional customer orders.
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: market and other conditions,
the regulatory and commercial risks associated with introducing the
COVID-19 IgG/IgM Rapid Test, shipping delays and their impact on
our ability to introduce the COVID-19 IgG/IgM Rapid Test, our
ability to enforce our exclusive rights to distribute the COVID-19
IgG/IgM Rapid Test in the jurisdictions set forth in the
distribution agreement, the ability of the COVID-19 IgG/IgM Rapid
Test to accurately and reliably test for COVID-19, the manufacture
of the COVID-19 IgG/IgM Rapid Test’s ability to manufacture
such testing kits on a high volume scale, manufacturing problems or
delays related to the COVID-19 IgG/IgM Rapid Test, our ability to
satisfy any labelling conditions or other FDA or other regulatory
conditions to sell the COVID-19 IgG/IgM Rapid Test Kit, the ability
to obtain a sufficient number of COVID-19 IgG/IgM Rapid Test kits
to meet demand if any, the demand or lack thereof for the COVID-19
IgG/IgM Rapid Test Kit, 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 operationsin 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 existingoperations, 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.
Item
9.01 Financial Statements and Exhibits.
(d) The following
exhibit is being filed herewith:
Exhibit
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Description
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Press release
announcement dated April 1, 2020
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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.
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AYTU BIOSCIENCE, INC.
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Date:
April 1, 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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Exhibit
99.1
Aytu BioScience Announces Receipt of Initial Shipment of 100,000
COVID-19 IgG/IgM Point-of-Care Rapid Tests; Additional 500,000
Tests on Order
Initial Shipment of 2-10 Minute COVID-19 Rapid Tests Received at
Company’s Englewood, Colorado Facility
ENGLEWOOD,
CO / ACCESSWIRE / April 1, 2020 / Aytu BioScience, Inc. (NASDAQ:
AYTU) (the “Company”), a specialty pharmaceutical
company focused on commercializing novel products that address
significant patient needs
announced today that it has received its first
Coronavirus Disease 2019 (“COVID-2019”) IgG/IgM Rapid
Test shipment containing 100,000 tests from the manufacturer. The
Company is now in the process of relabeling the test kits to comply
with Food and Drug Administration (FDA) requirements relating to
labeling of COVID-19 serology test kits and expects to begin
filling current backorders and additional incoming orders shortly
thereafter.
Additionally,
the Company expects to receive another 500,000 rapid tests from the
manufacturer in the next two to three weeks in order to fulfill
additional customer orders.
Josh
Disbrow, Chief Executive Officer of Aytu BioScience, commented,
“We’re pleased to have the first 100,000 tests now in
stock at our facility in Englewood, Colorado. The Company is now
preparing the kits for shipment to customers. Following the
completion of the labeling process and final clearance by FDA,
we’ll be shipping this initial inventory to healthcare
professionals across the country. While preparing these kits for
distribution, we are also preparing to receive our next shipment of
500,000 tests.”
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. The COVID-19
IgG/IgM Rapid Test is registered with the FDA and listed on the FDA
website as one of the serology tests allowed by the agency to be
commercialized in 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.
About Aytu BioScience, Inc.
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®, the
only FDA-approved nasal formulation of testosterone for men with
hypogonadism (low testosterone, or "Low T"), (ii) ZolpiMist™,
the only FDA-approved oral spray prescription sleep aid, and (iii)
Tuzistra® XR, the only FDA-approved 12-hour codeine-based
antitussive syrup. The pediatric portfolio includes (i)
AcipHex® Sprinkle™, a granule formulation of rabeprazole
sodium, a commonly prescribed proton pump inhibitor; (ii) Cefaclor,
a second-generation cephalosporin antibiotic suspension; (iii)
Karbinal® ER, an extended-release carbinoxamine
(antihistamine) suspension indicated to treat numerous allergic
conditions; and (iv) Poly-Vi-Flor® and Tri-Vi-Flor®, 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.
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® marketing and sales
platform.
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.
Contact for Media and Investors:
James
Carbonara
Hayden
IR
(646)
755-7412
james@haydenir.com
Contact for COVID-19 IgG/IgM Rapid Test-Related
Inquiries:
COVID-19@aytubio.com