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): April
16, 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:
☐
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Written
communications pursuant to Rule 425 under the Securities Act
(17 CFR 230.425)
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☐
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Soliciting
material pursuant to Rule 14a-12 under the Exchange Act (17
CFR 240.14a-12)
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☐
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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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☐
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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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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 16, 2020, Aytu BioScience, Inc. (the “Company”) a
specialty pharmaceutical company focused on commercializing novel
products that address significant patient needs announced today
that results from an independent clinical study using the
Company’s licensed Coronavirus Disease 2019
(“COVID-19”) IgG/IgM Rapid Test were published in the
journal Infection Ecology & Epidemiology, further validating
the accuracy, specificity and performance of the antibody rapid
test.
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 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.
Item 9.01 Financial Statements and Exhibits.
(d)
The following
exhibit is being filed herewith:
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Press
release announcement dated April 16, 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 16, 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 Positive Results from an Independently
Conducted Clinical Study of the Company’s Licensed COVID-19
IgG/IgM Point-of-Care Rapid Test
Independent
clinical study demonstrates test accuracy of 98.0% and 94.1% for
IgG and IgM, respectively, when using PCR-positive cases as true
positives
ENGLEWOOD,
CO / ACCESSWIRE / April 16, 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 results from an
independent clinical study using the Company’s licensed
Coronavirus Disease 2019 (“COVID-19”) IgG/IgM Rapid
Test were published in the journal Infection Ecology & Epidemiology,
further validating the accuracy, specificity and performance of the
antibody rapid test.
In this
recently published clinical study which included 29 COVID-19
positive cases confirmed by PCR and 124 healthy donors, the rapid
test showed an overall specificity of 100% and 99.2% for IgM and
IgG, respectively. The authors note, “The high negative
predictive value indicates that the rapid test will be useful for
detecting past infections and possible immunity, which may be
crucial for restoring social functions after
lockdown.”
Capillary
blood samples or serum from PCR-confirmed COVID-19 patients were
analyzed with results from the COVID-19 IgG/IgM Rapid Test.
Sixty-nine percent of samples from PCR-confirmed COVID-19 patients
tested IgM positive, and 93.1% tested IgG positive. These results
are well in line with the previously reported specificity of 91.9%
for IgG and IgM. The authors note that variability in samples
obtained during COVID-19 disease or convalescence period means that
in the PCR-confirmed cases, antibodies may not yet have had time to
develop. If this were the case, sensitivities of the test could
actually be higher.
Josh
Disbrow, Chief Executive Officer of Aytu BioScience, commented
“This independently conducted study, which was peer-reviewed
and published earlier this week, demonstrates the clinical
performance of this COVID-19 IgG/IgM rapid test and establishes the
test’s utility in understanding a patient’s past
exposure to COVID-19 and its potential to assess patient immunity
as we move past this pandemic and get our society back to work. We
are happy to see a leading clinical institution further establish
the clinical utility of this important serological
test.”
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 now been
validated in multiple independent trials and is CE
marked.
https://www.tandfonline.com/doi/full/10.1080/20008686.2020.1754538
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.
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