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Aytu BioScience (OTCMKTS:AYTU) Making Moves

Aytu BioScience (OTCMKTS:AYTU) Making Moves
Written by
Alex Carlson
Published on
January 14, 2016
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Aytu BioScience (OTCMKTS:AYTU) has become one of the most talked about names on the OTC markets. Things really kicked off last November after Ampio Biopharmaceuticals (AMPE) announced that it would distribute most of its 11,626,068 shares of Aytu to Ampio's current shareholders. The non-dilutive share distribution constituted greater than 70% of the current Aytu shares outstanding, which increases Aytu's stock liquidity substantially and further support Aytu as it operates as an independent public company. The timing couldn't be better as Aytu CEO Josh Disbrow stated:

"We are grateful to Ampio for its continued support and its recent decision to dramatically enhance Aytu's capacity to achieve higher valuations by having a truly liquid stock. This action is particularly timely, as Aytu is positioned for substantial near-term growth through the commercialization of our first urology products. In addition to these products, we are looking to expand our commercial footprint in the urology market, by seeking additional complementary urology products that serve significant medical needs. We look forward to providing updates on this growth strategy and our commercial development to our newly expanded shareholder base."

It's important to note that Aytu was just formed last year. In that time, Aytu has acquired two revenue-generating urology products: ProstaScint, a biologic imaging agent used by urologists to detect the extent and spread of prostate cancer, and Primsol, a urological antibiotic. To support these products, the Company developed its commercial infrastructure by hiring management personnel and a urology-focused sales force. Aytu is focused on growing revenue for these products and seeking opportunities to acquire additional commercial-stage assets within urology and related areas. In parallel, the Company presented encouraging data demonstrating the clinical utility of MiOXSYS® for measuring oxidative stress levels in semen and is pursuing an FDA clearance pathway for this product as a marker for male infertility. The Company also has a therapeutic candidate, Zertane, for treating premature ejaculation, which recently received approval from the FDA to initiate Phase 3 studies.Last month, Aytu got more credibility with the markets when it uplisted to OTCQX. As CEO Josh Disbrow said:

"We are excited about qualifying for the OTCQX market less than 10 months since the formation of Aytu BioScience. Considering the company's anticipated growth outlook in the near-term through the commercialization of our first urology products, moving up to OTCQX is an appropriate next step in the company's near-term growth plan. Being traded on OTCQX will allow for greater exposure, accessibility, and liquidity from the investment community as we execute on our commercially-focused strategy of building a specialty healthcare company in the urology field."

The most recent news is that Aytu has obtained CE Marking in Europe for its MiOXSYS™ System. MiOXSYS is the company's in vitro diagnostic platform for assessing the level of oxidative stress in semen as an aid in the diagnosis of infertility in males. This regulatory clearance positions Aytu for a launch in Europe and other markets and expands Aytu's portfolio of marketed products including ProstaScint and Primsol.

Aytu has conducted clinical studies in male infertility with a leading center in the United States and determined that oxidation-reduction potential, the key parameter reported by the MiOXSYS system, effectively measures oxidative stress levels in semen and seminal fluid. Additional studies are now underway in the US and around the world that will determine the MiOXSYS system's performance in semen analysis as it relates to a broad range of uses in male infertility. The company expects to initiate clinical trials in the United States to enable submission of MiOXSYS to the FDA.

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Aytu generated $262k in revenues in the quarter ended June 30, 2015. However, the company did burn through over $7m on R&D as well as SG&A expenses. Aytu needs to deliver some results this year to justify its $13m market cap. Be sure to sign up to Insider Financial as we will be updating subscribers with the latest on AYTU and its latest developments.

Disclosure: We have no position in AYTU either long or short. Our position at Insider Financial is not to take positions in company's that we cover so that we can remain objective for our subscribers. We have not been compensated for this article.

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