Aytu Biopharma, Inc 8-K, filed Apr 17, 2020
Aytu Biopharma, Inc (AYTU)
8-K
2020-04-17
For: 2020-04-17
View Original
Added on
April 10, 2026
About this 8-K
Aytu Biopharma, Inc filed this 8-K on April 17, 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): April
17, 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 17, 2020, Aytu BioScience, Inc. (the “Company”) a
specialty pharmaceutical company focused on commercializing novel
products that address significant patient needs announced today
that export and delivery of the Company’s incoming COVID-19
rapid tests remains on track as previously announced.
Additionally,
the Company is in late-stage negotiations to secure rights to
distribute a second COVID-19 IgG/IgM rapid test, which is approved
by China’s National Medical Products Administration
(NMPA).
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:
Exhibit Description
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Press
release announcement dated April 17, 2020
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2
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 17, 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 Confirms Export and Incoming Delivery of COVID-19
IgG/IgM Rapid Tests
Chinese Officials Confirm China Won’t Restrict Exports of
Medical Products Needed to Fight Coronavirus
Company in Late-Stage Negotiations
to Secure Distribution Agreement for Additional COVID-19 IgG/IgM
Rapid Test Which is Approved by China’s National Medical
Products Administration (NMPA)
ENGLEWOOD, CO / ACCESSWIRE / April 17, 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 export and delivery of the
Company’s incoming COVID-19 rapid tests remains on track as
previously announced.
Additionally, the Company is in late-stage negotiations to secure
rights to distribute a second COVID-19 IgG/IgM rapid test, which is
approved by China’s National Medical Products Administration
(NMPA).
Josh Disbrow, Chief Executive Officer of Aytu BioScience,
commented, “Since the Company began taking the fight to
COVID-19, we have continued to aggressively search for and evaluate
diagnostic tests and other novel technologies that may complement
our current product offering and benefit COVID-19 patients. Also,
given the nationwide shortage of tests, we believe we are obligated
to secure as many additional tests as we can to help with this
shortage. To that end, I am excited to say we’re in the final
stages of securing yet another IgG/IgM antibody rapid test for U.S.
distribution. This test is already approved by China’s NMPA,
is being regularly exported from China, and has strong clinical
performance. By securing this additional antibody test, we expect
to have an even greater supply to fulfill the substantial demand
we’re experiencing. We all need to continue to do the very
best we can to help COVID-19 patients and those medical
professionals for whom they care.”
Mr. Disbrow continued, “On March 31, an announcement was made
by China's Ministry of Commerce restricting the export of medical
materials that have not obtained approval from the NMPA. It is
important to note that just yesterday the Associated Press released
an article titled, ‘China says
no plans to limit export of anti-virus supplies.’ The article states: ‘Commerce
Ministry spokesman Gao Feng said Beijing has taken steps to
speed up customs clearance while ensuring the quality of exported
epidemic-prevention goods. Gao said Thursday, ‘China has not and will not restrict the export of
epidemic prevention materials.’ These statements provide us
with confidence and are consistent with the information we continue
to receive from our test kit licensor. We remain confident about
the timely delivery of the Company’s incoming order of
COVID-19 IgG/IgM tests,” commented Mr.
Disbrow.
Mr. Disbrow concluded, “We have received further confirmation
that the COVID-19 IgG/IgM Rapid Test manufactured by Zhejiang
Orient Gene is in the approval process with NMPA. We remain highly
confident in the test’s clinical performance as recently
demonstrated in a published, third-party peer-reviewed study
and believe that the Zhejiang Orient
Gene COVID-19 IgG/IgM Rapid Test is a reliable test in detecting
COVID-19 antibodies. The independent study demonstrates test accuracy of 98.0% and 94.1% for
IgG and IgM, respectively, when using PCR-positive cases as true
positives, which we believe establishes strong clinical utility of
the test.”
The Company will continue to inform our stakeholders about our
continuing developments relating to our COVID-19 fight and the
progress of the Aytu BioScience business.
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:
James Carbonara
Hayden IR
(646) 755-7412
james@haydenir.com