Englewood, CO – May 17, 2017 – Aytu BioScience, Inc. (OTCQX: AYTU), a specialty pharmaceutical company focused on global commercialization of novel products in the field of urology, today announced that it presented one poster presentation illustrating safety benefits of Natesto® therapy and its preservation of pituitary gonadotropin hormones, which are integral in male fertility. A podium session was also presented, which demonstrated significant improvement in all domains of erectile function as well as improvement in mood with Natesto therapy.
Josh Disbrow, Chief Executive Officer of Aytu BioScience, stated, “In collaboration with leading experts in the urology field, we continue to demonstrate a wide breadth of clinical and scientific data surrounding Natesto. These two presentations at the American Urological Association annual meeting highlight Natesto’s distinct efficacy profile as it relates to improving erectile function and mood in hypogonadal men, while also demonstrating Natesto’s safety in maintaining pituitary gonadotropin levels in the standard male adult range throughout treatment.”
The presentations were as follows:
Title: Preservation of Normal Concentrations of Pituitary Gonadotropins Despite Achievement of Normal Serum Testosterone Levels in Hypogonadal Men Treated with a 4.5% Nasal Testosterone Gel
Poster Number: MP89-06
Session: Infertility: Therapy I
Presenter: Williams Conners, MD, Harvard Medical School, Urology
Conclusion: Treatment with Natesto restored serum testosterone levels to normal levels in hypogonadal men, while the pituitary gonadotropin levels were reduced, but remained within the standard adult ranges.
Title: Clinical Improvements in Erectile Function and Mood in Hypogonadal Men Treated with 4.5% Nasal Testosterone Gel
Podium Session Number: PD69-06
Presenter: Larry Lipshultz, MD, Baylor College of Medicine, Urology
Conclusion: Treatment with Natesto demonstrated significant improvement in all domains of erectile function (p<0.0001) as early as Day 30, and improvement continued through treatment period (Day 90). Treatment with Natesto showed substantial improvement in mood as early as 30 days (p<0.0001), and continued through treatment period (Day 90) quantified by positive and negative affect.
Selection of the abstracts for publication in the press program does not imply endorsement of Natesto by AUA.
About Aytu BioScience, Inc.
Aytu BioScience is a commercial-stage specialty pharmaceutical company focused on global commercialization of novel products in the field of urology, with a focus on products addressing vitality, sexual wellness, and reproductive health. The company currently markets two prescription products in the U.S.: Natesto®, the first and only FDA-approved nasal formulation of testosterone for men with hypogonadism (low testosterone, or “Low T”) and ProstaScint® (capromab pendetide), the only FDA-approved imaging agent specific to prostate specific membrane antigen (PSMA) for prostate cancer detection and staging. 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 product, and Aytu is planning U.S.-based clinical trials in pursuit of 510k medical device clearance by the FDA. 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 growing markets. For more information visit aytubio.com. Aytu also now owns wholly-owned subsidiary Nuelle, a personal health and wellness company focused on women’s sexual wellbeing and intimacy that markets Fiera, a personal care device for women that is scientifically proven to enhance physical arousal and sexual desire. Fiera is a consumer device and is not intended to treat, mitigate, or cure any disease or medical condition. For more information about Aytu BioScience visit aytubio.com. For more information about the Fiera personal care device visit fiera.com.
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, 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: our anticipated future cash position and our need for additional capital in the near term, the risk of integrating Nuelle into our operations and realizing benefits from the acquisition, risks relating to gaining and increasing 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, 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, as amended by our Form 10-Q for the quarter ended March 31, 2017 and in the other reports and documents we file with the Securities and Exchange Commission from time to time.
Amato and Partners, LLC
Investor Relations Counsel