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Issuer Free Writing Prospectus
Filed pursuant to Rule 433
Registration No. 333-213738
Aytu BioScience Corporate Overview | October 2016
Safe Harbor Statement This presentation 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; the timing, costs and results of our 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. 2
Offering Summary 3 Aytu BioScience , Inc. Expected Offering Up to approximately $12,500,000 of common stock and warrants (100% Primary) Listing OTCQX : A YTU & AYTUW We intend to list our common stock and warrants on the NYSE MKT under the symbols “AYTU” and “AYTUW”, respectively, once we meet NYSE listing standards by raising $8,500,000 and achieving a $3.00 per share price, which we expect to do via a reverse split once approved by our stockholders in November.* Over - allotment 15% (100% Primary) Use of Proceeds Upfront payment for exclusive license to Natesto, further commercialization of Natesto, ProstaScint and Primsol , funding of remaining clinical development of MiOXSYS to enable FDA clearance, acquisition of complementary urology assets, and working capital for general corporate and administrative purposes Joint Book - Runners Joseph Gunnar & Company and Feltl and Company Lead Manager Fordham Financial Management * The company filed a notification to shareholders on October 5, 2016 and will hold a shareholder meeting on November 15, 2016 during which meeting the shareholders are expected to approve an amendment to our Certificate of Incorporation to effect a reverse stock split at a ratio of any whole number between 1 - for - 2 and 1 - for - 4, as determined by our board of directors, at any time after November 15, 2016 and before November 15, 2017.
Company Description • Specialty Pharmaceutical Company, Focused on Urology – Hypogonadism, prostate cancer, male infertility, & urinary tract infections • Experienced, entrepreneurial management team with proven success in launching and growing specialty pharmaceutical companies – Founding management team grew Arbor Pharmaceuticals from inception to over $127MM in net revenue in five years; • Complimentary Urology Products and Pipeline – Natesto ® (testosterone), FDA - approved, Only nasally administered testosterone for treatment of hypogonadism (“Low T”) – ProstaScint ® ( capromab pendetide ), FDA - approved, the only radioimaging agent indicated to detect prostate specific membrane antigen (PSMA) in the assessment and staging of prostate cancer – MiOXSYS ™ System, CE Marked, conducting FDA 510(k) clinical trial, a novel point - of - care semen analysis system with the potential to become a standard of care in the diagnosis and management of male infertility – Primsol ® (trimethoprim hydrochloride), FDA - approved, the only trimethoprim - only oral solution for urinary tract infections • Active Business Development for Additional Urology Assets – Expanding Portfolio of Revenue - Generating Urology Products • Large Addressable Markets with IP - Protected Assets • Established Urology - Focused Commercial Infrastructure 4
AYTU History 5 Jan 2016 spinout from Ampio Pharma (AMPE) Acquired U.S. rights to Natesto® - launching into $2.4BN testosterone replacement therapy market $7.5 million registered offering completed in May 2016 FY 2016 Results : Net revenues of $2.6 million; 10x growth over FY 2015 $8.1M in cash 3 marketed, FDA - approved urology products acquired in less than 11 months Commercial infrastructure scaled and launched Natesto launch successfully underway with nationwide urology - centric sales force
Complementary Urology Products and Pipeline 6 Established, Revenue - Generating Products • FDA - approved imaging agent for prostate cancer detection and staging 2 : • Newly diagnosed patients at higher risk for pelvic lymph node disease • Patients with suspected recurrent disease • Only FDA - approved trimethoprim oral solution; indicated for urinary tract infections 3 • Appropriate for patients with ‘sulfa’ allergies in non - pill formulation • Significant prescribing by urologists despite no promotion Late - Stage Diagnostic Asset for Male Infertility • CE Marked in vitro diagnostic device for male infertility 4 , Single FDA study pending • Initial ex - U.S. revenues ramping; devices placed at leading infertility and andrology centers around the world including Cleveland Clinic 1. Natesto Prescribing Information. 2. ProstaScint Prescribing Information. 3. Primsol Prescribing Information. 4. MiOXSYS Instructions for Use and Clinical Study Summary. Just Launched in the U.S. – July 25, 2016 • Only FDA - approved, nasally - administered testosterone; indicated for hypogonadism 1 • Approved for use WITHOUT black box warning related to testosterone transference
Natesto®: Launching the only FDA - approved, nasally - administered testosterone replacement therapy
• More than $2BN in annual product class revenues – U.S. Testosterone Replacement Therapy (TRT) market expected to grow to over $5BN by 2017 1 • Current topical treatments ( AndroGel ®, Axiron ®) have BLACK BOX WARNING related to transference of TRT, causing androgen/male - trait enhancing side effects in women (hair growth, male pattern baldness, etc.) 2 - 3 • Decrease in branded promotion in TRT category, yet substantial treatment needs remain 4 – Substantially reduced direct - to - consumer advertising related to FDA statements 5 $2.4 Billion Market Size ($U.S. - 2013) 13 Million Prevalence (U.S. Men) Significant Market Need Testosterone Market Opportunity 8 1. Annual testosterone drug revenue in the U.S. in 2013 and 2018 (in billion U.S. dollars). Statista: The Statistics Portal. Ac cessed at http://www.statista.com/statistics/320301/predicted - annual - testosterone - drug - revenues - in - the - us/. 2. AndroGel Prescribing Information. 3. Axiron Prescribing Information. 4. Tartavoulle TM, Porche DJ. Low Testosterone. Journal for Nurse Practitioners. 2012;(8): 778 - 786 Accessed at http://www.medscape.com/viewarticle/775165_3. 5. Wasserman E. AndroGel . The top 10 patent losses of 2015. FirecPharma . October 16, 2014.
Natesto (testosterone) nasal gel FDA - Approved Testosterone • Uniquely - delivered, strongly patented TRT with multiple advantages over competitors 1 - 3 • Only nasally - administered TRT • Unique, low - dose of testosterone • No BLACK BOX WARNING associated with transference of testosterone • Discreet product presentation and ease of transport • Natesto is an androgen indicated for replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone including 1 - 2 : • Primary hypogonadism • Hypogonadotropic hypogonadism • More discreet, easy - to - administer than other TRTs with no risk of transference to partner; No painful subcutaneous or IM injection 2 9 1. Natesto Prescribing Information. 2. Natesto.com. 3. FDA Approved Drug Products. Accessed at https://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.DrugDetails
Natesto: Proven Effective 2 - 3 Times Daily with No Risk of Transference • In the pivotal clinical trial studying the safety and efficacy of Natesto, which was conducted at 39 U.S. outpatient sites it was shown at day 90 1 : – 70% of the per protocol patients in the B.I.D. ‘titration arm’ (n=141) achieved normal testosterone levels. – 91% percent of the per protocol patients in the T.I.D. group (n=77) achieved normal testosterone levels • The majority of men in both Natesto treatment groups achieved normalization of testosterone levels, with a low incidence of rising PSA levels 1 - 2 . 10 1. Rogol AD, Tkachenko N, Bryson N. Natesto, a novel testosterone nasal gel, normalizes androgen levels in hypogonadal men. Andrology . 2016, 4: 46 - 54. 2. Natesto Prescribing Information.
Natesto: TRT in Seconds • Natesto will be positioned for active men with hypogonadism between 45 – 64 years of age for whom convenience, discretion, and quick use of a TRT is important. – Natesto is easy, quick to apply, and doesn’t add to the busy morning (or evening) routine – or complicate a man’s unpredictable travel or work schedule 1 - 2 – Other TRTs involve time - consuming, indiscreet application of gels ( AndroGel ®, Fortesta ®) or solutions ( Axiron ®) that involve covering large areas of the
The above information was disclosed in a filing to the SEC. To see the filing, click here.
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Other recent filings from the company include the following:
General form for registration of securities under the Securities Act of 1933 - Sept. 22, 2017
General form for registration of securities under the Securities Act of 1933 - Sept. 5, 2017
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