AYTU BIOSCIENCE, INC. (OTCMKTS:AYTU) Files An 8-K Regulation FD Disclosure
ME Staff 8-k
AYTU BIOSCIENCE, INC. (OTCMKTS:AYTU) Files An 8-K Regulation FD Disclosure 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:
AYTU BIOSCIENCE, INC Exhibit EX-99.1 2 aytu_ex991.htm PRESS RELEASE aytu_ex991 Exhibit 99.1 Aytu BioScience Announces China Export Clearance of Company’s COVID-19 IgG/IgM Rapid Test 500,… To view the full exhibit click here
About AYTU BIOSCIENCE, INC. (OTCMKTS:AYTU)
Aytu BioScience, Inc. is a commercial-stage healthcare company focused on acquiring, developing and commercializing products in the field of urology. The Company focuses on hypogonadism, prostate cancer, urinary tract infections and male infertility. The Company markets ProstaScint (capromab pendetide), a radio imaging agent indicated to detect the prostate specific membrane antigen (PSMA) in the assessment and staging of prostate cancer. The Company also markets Primsol (trimethoprim hydrochloride), a trimethoprim-only oral solution for urinary tract infections. The Company’s pipeline includes MiOXSYS, an in vitro diagnostic device. MiOXSYS system is a point-of-care semen analysis system, used for diagnosis and management of male infertility. The Company holds the United States rights to Natesto (testosterone), a formulation of testosterone delivered through a nasal gel. Natesto is used for the treatment of hypogonadism (low testosterone) in men.