Aytu Biopharma, Inc 8-K, filed May 7, 2020
Aytu Biopharma, Inc (AYTU)
8-K
2020-05-07
For: 2020-05-07
View Original
Added on
April 10, 2026
About this 8-K
Aytu Biopharma, Inc filed this 8-K on May 7, 2020.
Items reported
- Item 2.02: Financial results
- 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 7, 2020
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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:
☐
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:
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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 2.02 Results of Operations and Financial
Condition.
On
May 7, 2020, the Company
issued a press release announcing that the Company will present its
operational results for the fiscal third quarter ended March 31,
2020 on Thursday, May 14, 2020, at 4:30 p.m. ET. A copy of the
press release is attached as Exhibit 99.1 and incorporated herein
by reference.
In
accordance with General Instruction B.2 of Form 8-K, the
information in the press release attached as Exhibit 99.1 hereto
shall not be deemed to be “filed” for purposes of
Section 18 of the Securities Exchange Act of 1934, as amended (the
“Exchange Act”), nor shall such information be deemed
incorporated by reference in any filing under the Securities Act of
1933, as amended, or the Exchange Act, except as shall be expressly
set forth by specific reference in such filing.
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: our ability to successfully
commercialize the Healight platform technology, our ability to
obtain FDA authorization for use or approval for the Healight
platform technology, the safety and/or effectiveness of the
Healight platform technology in treating patients with COVID-19 or
other illnesses, our ability to adequately protect the intellectual
property associated with the Healight platform technology,
regulatory delays, the reliability of the Healight platform
technology in killing viruses and bacteria, market acceptance of UV
based medical devices, risks associated with the our COVID-19 rapid
tests including our ability to enforce the exclusivity provisions
of the distribution agreements, the reliability of serological
testing in detecting COVID-19, shipping delays and their impact on
our ability to introduce the COVID-19 rapid tests, the ability of
the COVID-19 rapid tests to accurately and reliably test for
COVID-19, the manufacturers of the COVID-19 rapid tests’
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
kits, the demand or lack thereof for the COVID-19 rapid test kits,
our ability to obtain additional COVID-19 rapid tests to meet
demand, our ability to secure additional tests if the manufactures
of the COVID-19 rapid tests are 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 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.
The
following exhibit is being filed herewith:
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Exhibit
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Description
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Press
Release dated May 7, 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: May
7,
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 to Report Fiscal Q3 FY 2020 Results and Business
Update
ENGLEWOOD, CO May 7, 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 the Company will present its
operational results for the quarter ended March 31, 2020 on May 14,
2020, at 4:30 p.m. ET. The Company will review accomplishments from
the quarter and provide an overview of its business and growth
strategy.
Conference Call Information
1- 877-407-9124 (toll-free)
1- 201-689-8584 (international)
The webcast will be accessible live and archived on Aytu
BioScience's website, within the Investors section under Events
& Presentations, at aytubio.com, for 90 days.
A replay of the call will be available for fourteen days. Access
the replay by calling 1-877-481-4010 (toll-free) or 919-882-2331
(international) and using the replay access code
34718.
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.
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