Aytu Biopharma, Inc 8-K, filed May 1, 2020
Aytu Biopharma, Inc (AYTU)
8-K
2020-05-01
For: 2020-05-01
View Original
Added on
April 10, 2026
About this 8-K
Aytu Biopharma, Inc filed this 8-K on May 1, 2020.
Items reported
- Item 7.01: Regulation FD disclosure
- Item 9.01: Financial statements and exhibits
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): May
1, 2020
AYTU BIOSCIENCE, INC.
(Exact
name of registrant as specified in its charter)
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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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☐
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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:
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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
April 30, 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 confirmation of export approval for product
shipment by China’s Ministry of Commerce for the
Company’s COVID-19 IgG/IgM Rapid Test.
Forward-Looking Statement
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.
Item 9.01 Financial Statements and Exhibits.
(d)
The following exhibit is being filed herewith:
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Exhibit
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Description
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Press Release dated
April 30, 2020
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1
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:
May 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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2
Exhibit 99.1
Aytu BioScience Announces China Export Clearance of Company’s
COVID-19 IgG/IgM Rapid Test
500,000 Rapid Tests Cleared for Shipment to Company’s
Warehouse
ENGLEWOOD,
CO / ACCESSWIRE / April 30, 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
confirmation of export approval for product shipment by
China’s Ministry of Commerce for the Company’s COVID-19
IgG/IgM Rapid Test.
Josh
Disbrow, Chief Executive Officer of Aytu BioScience, commented,
“The backlog of medical products being exported from China
created a shipment delay, but Aytu’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.”
About Aytu BioScience, Inc.
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®, 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 126 patient
clinical trial in China 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