AYTU BIOSCIENCE, INC. (OTCMKTS:AYTU) Files An 8-K Other Events

AYTU BIOSCIENCE, INC. (OTCMKTS:AYTU) Files An 8-K Other Events
Item 8.01 Other Events

On April 3, 2020, Aytu BioScience, Inc. (the “Company”) a specialty pharmaceutical company focused on commercializing novel products that address significant patient needs announced today that it began shipping its Coronavirus Disease 2019 (“COVID-2019”) IgG/IgM Rapid Test to U.S. customers. Upon receipt of the initial 100,000 tests, the company completed product relabeling to ensure compliance with FDA guidance on COVID-19 serology test kits.
The Company has received orders for the COVID-19 IgG/IgM Rapid Test from a broad range of healthcare customers including large medical centers, municipalities, first responders, medical practices, and other healthcare customers. The Company expects to have all customer backorders filled in the coming days.
Forward-Looking Statements
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

AYTU BIOSCIENCE, INC Exhibit
EX-99.1 2 aytu_ex991.htm PRESS RELEASE aytu_ex991   Exhibit 99.1   Aytu BioScience Announces First Commercial Shipment of its 2-10 Minute COVID-19 IgG/IgM Point-of-Care Rapid Test   First COVID-19 Rapid Tests Delivered to Denver First Responders   ENGLEWOOD,…
To view the full exhibit click here

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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.

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