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Aytu BioScience Announces Enrollment of First Twenty Patients in the Natesto(R) Spermatogenesis Study

University of Miami Study is First to Assess Natesto's Impact on Sperm Production and Gonadotropin Levels

ENGLEWOOD, CO / ACCESSWIRE / July 17, 2018 / Aytu BioScience, Inc. (AYTU), a specialty pharmaceutical company focused on global commercialization of novel products addressing significant medical needs, today announced that the first twenty patients have been enrolled in the company's investigator-initiated study assessing the impact of Natesto® on sperm production and gonadotropin levels. This study is being conducted at the University of Miami's Department of Urology, and Dr. Ranjith Ramasamy, MD, the Director of Reproductive Urology, is the study's principal investigator.

This clinical study entitled, "Natesto Effects on Testosterone, Luteinizing Hormone, Follicle Stimulating Hormone and Semen Parameters" seeks to establish if Natesto (Aytu BioScience's testosterone nasal gel) maintains sperm production, gonadotropin levels, and endogenous testosterone levels. Testosterone therapy (TTh) is known to decrease gonadotropin levels, diminish sperm production and function, and decrease the natural production of endogenous testosterone in men being treated with TTh. Maintenance of fertility and family planning is a major discussion point when it comes to men with low testosterone and their available treatment options. Thus, if this study establishes a muted or negligible effect of Natesto on these parameters, it would be the first such TTh treatment and study to establish this unique, unexpected effect.

Dr. Ranjith Ramasamy commented, "Currently, there are no FDA-approved therapies to treat men with low testosterone who wish to preserve their fertility. About 20% of men with Low T deal with these decisions, and Natesto could be an alternative for simultaneously increasing testosterone while preserving sperm production."

Forty patients will be enrolled in this open label, single group, interventional study, and the investigators expect study completion by Summer 2019, with study results being reported following completion. An interim readout of results is expected to occur by November of 2018, and preliminary results are expected to be presented at an upcoming scientific conference.

Josh Disbrow, Chief Executive Officer of Aytu BioScience explained, "We thank Dr. Ramasamy for leading this important clinical study and are pleased to have patient enrollment underway. The results of this study could significantly change the way clinicians approach the treatment of hypogonadism and TTh, as Natesto would become the only available TTh option that has been shown to preserve sperm production in men treated with testosterone therapy. We look forward to providing additional updates on this clinical study as it progresses and as we approach the announcement of interim and final results."

Aytu BioScience is sponsoring this investigator-initiated trial, and complete details on this study can be found at https://clinicaltrials.gov/ct2/show/NCT03203681?term=Natesto&rank=4

About Aytu BioScience, Inc.

Aytu BioScience is a commercial-stage specialty pharmaceutical company focused on global commercialization of novel products addressing significant medical needs. The company currently markets Natesto®, the only FDA-approved nasal formulation of testosterone for men with hypogonadism (low testosterone, or "Low T"). Additionally, Aytu is developing MiOXSYS®, a novel, rapid semen analysis system with the potential to become a standard of care for the diagnosis and management of male infertility caused by oxidative stress. MiOXSYS is commercialized outside the U.S. where it is a CE Marked, Health Canada cleared, Australian TGA approved product, and Aytu is planning U.S.-based clinical trials in pursuit of 510k medical device clearance by the FDA. Aytu recently acquired exclusive U.S. rights to Zolpimist™, an FDA-approved, commercial-stage prescription sleep aid indicated for the short-term treatment of insomnia characterized by difficulties with sleep initiation. 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, growing markets. For more information visit aytubio.com.

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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, including statements regarding our anticipated future clinical and regulatory events, future financial position, business strategy and plans and objectives of management for future operations, 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: risks relating to gaining market acceptance of our products, obtaining reimbursement by third-party payors, 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 collaborations. We also refer you to the risks described in "Risk Factors" in Part I, Item 1A of Aytu BioScience, Inc.'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.

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SOURCE: Aytu BioScience, Inc.