Item
7.01 Regulation FD Disclosure
On
April 20, 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 signed an exclusive worldwide license from Cedars-Sinai
to develop and commercialize the Healight Platform Technology
(“Healight”). This medical device technology platform,
discovered and developed by scientists at Cedars-Sinai, is being
studied as a potential first-in-class treatment for coronavirus and
other respiratory infections.
The
company believes the Healight Platform Technology has the potential
to positively impact outcomes for critically ill patients infected
with coronavirus and other respiratory infections. The company
licensed exclusive worldwide rights to the technology from
Cedars-Sinai for all endotracheal and nasopharyngeal indications.
Patents have been filed by Cedars-Sinai Department of Technology
Transfer, and Aytu BioScience will manage all aspects of
intellectual property prosecution and filing globally. Aytu
BioScience expects to partner the product outside the
U.S.
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 Healight Platform Technology, our ability to obtain
FDA approval for the Healight Platform Technology, the
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 COVID-19 Rapid Test including 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 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.Commission
from time to time.