Item 7.01 Regulation FD Disclosure
On
April 23, 2020, Aytu BioScience, Inc. (the “Company”) a
specialty pharmaceutical company focused on commercializing novel
products that address significant patient needs announced the
signing of a definitive agreement (the “Agreement”)
with Singapore-based Biolidics, Limited (SGX: 8YY;
“Biolidics”) to exclusively distribute Biolidics’
COVID-19 IgG/IgM Rapid Test in the United States.
Under
the terms of the Agreement, Aytu will exclusively distribute
Biolidics’ COVID-19 IgG/IgM rapid antibody test in the United
States. Aytu has committed to purchase 500,000 tests within one
business day from the date of signing of the Agreement. As an
additional component of Aytu’s exclusivity, the Company has
committed to purchase a minimum of 1,250,000 tests within the first
three months of the Agreement.
Biolidics’
COVID-19 IgG/IgM Rapid Test has been issued Provisional
Authorization for distribution by Singapore’s Health
Science’s Authority (HSA), and the product has been
authorized for export from Singapore. Biolidics’ COVID-19
IgG/IgM Rapid Test will be supplied from Biolidics’ facility
in Singapore.
Aytu
will collaborate with Biolidics and lead the U.S. clinical trials
processes and plans to complete and obtain U.S. Food and Drug
Administration (“FDA”) 510k regulatory filing clearance
of the COVID-19 IgG/IgM rapid test kits.
Forward-Looking Statement
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 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.