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Aytu BioScience Corporate Overview | Q2 2015

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Page 1: Aytu BioScienceaytubio.com/wp-content/uploads/2015/05/Aytu-Corporate-Presentati… · • Majority of PE patients report lack of effective treatment for their PE • Traditional remedies

Aytu BioScience Corporate Overview | Q2 2015

Page 2: Aytu BioScienceaytubio.com/wp-content/uploads/2015/05/Aytu-Corporate-Presentati… · • Majority of PE patients report lack of effective treatment for their PE • Traditional remedies

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. Such forward-looking statements include, without limitation, statements regarding 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. These forward-looking statements are subject to a number of risks, uncertainties and assumptions, including without limitation to the risks described in “Risk Factors” in Part I, Item 1A of Rosewind Corporation 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. These risks are not exhaustive. Other sections of Rosewind Corporation Annual Report on Form 10-K and such other filed reports and documents include additional factors that could adversely impact our business and financial performance. Moreover, we operate in a very competitive and rapidly changing environment. New risk factors emerge from time to time and it is not possible for our management to predict all risk factors, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements. You should not rely upon forward-looking statements as predictions of future events. We cannot assure you that the events and circumstances reflected in the forward-looking statements will be achieved or occur and actual results could differ materially from those projected in the forward looking statements. We assume no obligation to update or supplement forward-looking statements.

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Corporate Highlights

Expanding Pipeline of Novel Urology Products

Lead Candidate Zertane™ is Phase 3 Ready

Commercial-stage with Acquisition of ProstaScint®

Proprietary Diagnostic for Male Infertility

Established Global Commercial Agreements

Strong IP & Entrepreneurial Management

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Page 4: Aytu BioScienceaytubio.com/wp-content/uploads/2015/05/Aytu-Corporate-Presentati… · • Majority of PE patients report lack of effective treatment for their PE • Traditional remedies

Build a specialty healthcare company with an initial focus on the $10B urology

by establishing a leading pipeline of novel therapeutic and diagnostic assets

Core Urology Focus Adjacent Areas

• Premature Ejaculation

• Male Infertility

• Urological Cancers

• Erectile dysfunction

• Hypogonadism

• Prostate, BPH • Incontinence, bladder

Product Development & Commercial Strategy

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Complementary Urology Products and Pipeline

Therapeutics Development

• Proprietary, commercial-stage redox diagnostic research tool

• Developing clinical applications in male infertility for use in semen analysis

• Clinical development program in place with major US academic center

Lead Therapeutic Candidate:

• First-in-class, near

commercial-stage treatment for premature ejaculation

• Global commercial agreements in place

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Diagnostics Development

• FDA-approved biologic for detection of prostate cancer lymph node metastasis in: • Newly diagnosed

patients at higher risk for pelvic lymph node disease

• Patients with suspected recurrent disease

Therapeutics Commercialization

Marketed Product: Lead Diagnostic Candidate:

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ProstaScint® (capromab pendetide) FDA-Approved Prostate Biologic ACS Prostate Cancer

• First-in-class monoclonal antibody imaging agent • Binds glycoprotein expressed by prostate

epithelium – Prostate Specific Membrane Antigen (PSMA)

• Enables accurate staging and guides appropriate

treatment, with emphasis on: • Higher risk, newly diagnosed – to identify

organ confined disease • Treatment failures post-curative intent – to

identify candidates for localized therapy

• Uses an injection of low-level radioactive material to determine if cancer has spread beyond the prostate

Preclinical

Phase 1

Phase 2

Phase 3 FDA Approved/Marketed

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EARLY DETECTION, DIAGNOSIS, AND STAGING TOPICS

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• Most common cancer in American men, other than skin cancer

• Second leading cause of cancer death in American men

– ~1 in 38 men will die of prostate cancer

– ~27,540 prostate cancer deaths in 2015

• Accurate staging is critical for patient management

– 10% of new cases are considered high risk

– 20-40% of patients will recur following curative intent treatment

2.9 MM

Prostate Cancer Prevalence (U.S.)

220,800

Annual New Prostate Cases (U.S.)

Significant Market Need

Prostate Cancer Market Opportunity

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Zertane™ (Tramadol ODT) Late-Stage Therapeutic Candidate Orally Dissolving Tablet

• First-in-class therapy nearing commercial-stage for treating premature ejaculation (PE) • Currently preparing to initiate pivotal U.S.

clinical study • Approval pathway is significantly de-risked

• Success in two European Phase 3, two Phase 2, and two Phase 1 trials

• 505(b)(2) path reduces costs and time to market

• Prepared for the global market

• Commercial agreements in place for Canada, South Korea, and Latin America

• Management team built and launched commercial teams at specialty pharma companies

Improved oral formulation of a widely known and safe drug (tramadol hydrochloride) that is proven to treat premature ejaculation

Preclinical

Phase 1

Phase 2

Phase 3 Pivotal Study

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Page 9: Aytu BioScienceaytubio.com/wp-content/uploads/2015/05/Aytu-Corporate-Presentati… · • Majority of PE patients report lack of effective treatment for their PE • Traditional remedies

• Most widely observed male sexual dysfunction

• Currently no FDA-approved products • Majority of PE patients report lack of

effective treatment for their PE

• Traditional remedies have limited effectiveness and unwanted side effects

• Market research suggests an oral, as-needed formulation is in demand

23-30%

Global PE Prevalence

>$1.3B

U.S. Market in 2015

Attractive Competitive Landscape

PE Market Opportunity

9 (Source – Campbell Alliance)

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Zertane Phase 3: Improvement in validated co-primary endpoints following full development program

3.17

6

0

1

2

3

4

5

6

7

Six-Fold Increase in Ejaculation Time (IELT) versus Baseline**

Placebo 89 mg tramadol ODT

* Significant improvement also seen in satisfaction with intercourse, control over ejaculation, and ejaculation-related interpersonal difficulty

** Reflects patients with baseline IELT of <1 minute (0.60 minutes median)

(Source – European Urology 2012)

p < 0.01

10

0.55

1.05

0

0.2

0.4

0.6

0.8

1

1.2

Ejaculation-related distress*

(mean change)

Placebo 89 mg tramadol ODT

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Zertane normalized IELT in many patients

8%

6% 6%

4%

20%

18%

16%

11%

0%

5%

10%

15%

20%

25%

> 5 minutes > 6 minutes > 7 minutes > 8 minutes

Placebo 89 mg tramadol ODT

% o

f Pa

tien

ts N

orm

aliz

ed

NOTE: Reflects patients with baseline IELT of <1 minute (0.60 minutes median)

(Source – European Urology 2012)

p < 0.01

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Prepared for Zertane Pivotal Study Initiation

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• Concise, well-defined FDA pathway – FDA meeting Q4 2014 confirmed:

• Co-primary endpoints (IELT, POPE/PRO)

• Inclusion/exclusion criteria including PE definition

– FDA protocol and patient reported outcome questionnaire reviewed in detail Q1/2 2015

• 21 experienced study sites qualified and selected

• Selected CRO, defined budget

• Study drug manufactured and available

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• First-in-class, market-ready product

– Significant market opportunity in detection of oxidative stress in male infertility

– CE Marked (2014); Health Canada approved (2014)

– U.S. clinical pathway is short and well defined

– Clinical research underway with major US academic center in semen analysis

• Technical development complete following two decades of R&D

– Completed product development with CE Mark

– Received ISO 13485 certification with CMDCAS

– First patents issued in 2012; 7 US patents issued, multiple ex-US patents

• Razor-razorblade commercial model

– Inexpensive analyzer / high-value, disposable sensors

– Early research revenues from pharma and academic collaborators

RedoxSYS®: Meeting a Significant Need in Male Infertility

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• Attractive, growing market

– largely paid out-of-pocket

– >$10K for IVF treatment, with many couples repeating cycles

• Oxidative stress broadly implicated

– Antioxidants commonly recommended without FDA-approved test to assess efficacy

– Current testing platforms are cost-prohibitive and impractical for routine use

• Potential to replace current oxidative stress testing platform

– Active collaboration for RedoxSYS with world’s most widely published research group in male infertility

6.6%

Global GAGR (2013-2020)

>$300 MM

Global Market in 2020

Attractive Competitive Landscape

Male Infertility Market Opportunity

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Strong Intellectual Property Across Portfolio

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– 1 issued; 4 pending US patents

– 77 issued; 5 pending patents internationally

– Use of tramadol hydrochloride to treat PE through 2022

– Combination of Zertane and PDE-5 inhibitors through 2028

– Multiple life cycle management opportunities

• Alternate dosage forms

• Enhanced PK profile

Zertane™

– Proprietary monoclonal antibody with significant trade secrets throughout complex manufacturing processes

ProstaScint®

– 6 issued; 11 pending US patents

– 5 issued; 45 pending patents internationally

– Multiple apparatus/composition patent families

– Multiple use patents across infertility, acute illness, chronic illness, and use in various fields of human and animal research

– Significant trade secrets throughout complex manufacturing processes

RedoxSYS®

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Aytu Management

Josh Disbrow, Chief Executive Officer • Previously COO of Ampio Pharmaceuticals/CEO of Luoxis

• Former VP of Commercial Operations at Arbor Pharmaceuticals

• Commercial roles at LipoScience (NASDAQ: LPDX), Cyberonics (NASDAQ: CYBX), GlaxoSmithKline (NYSE: GSK)

Jarrett Disbrow, Chief Operating Officer • Founder and former President/CEO of Arbor Pharmaceuticals

• Previously CEO of Vyrix Pharmaceuticals

• Commercial roles at Accentia Pharmaceuticals, GlaxoSmithKline

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Upcoming Milestones

Product Event Q2’15 Q3’15 Q4’15 Q1’16

Complete Acquisition

Commercial Launch

IND Acceptance

Initiate 1st Phase 3

male infertility initial study results

Initiate FDA infertility clinical studies

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Current Therapeutic Pipeline Expansion + Licensing

Zertane

• Pivotal trial initiation • First-in-class treatment

for PE • Efficient 505(b)2 FDA

pathway • Commercial partnerships

in place in major international markets

• Expand ProstaScint utilization

• Seek to acquire additional revenue-generating assets with a focus on urology

• Consider acquiring late-stage development (Phase 3 only) programs in urology

Diagnostic Pipeline

• Prospective infertility research studies underway

• Research focus to drive revenue via industry and awareness via academic collaborations

• Strong IP Portfolio

Investment Highlights

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