Corporate Presentation January 13, 2010 URGP.OB Urigen Pharmaceuticals, Inc. 27 Maiden Lane, #595 San Francisco, CA 94108 415 781-0350 www.urigen.com
Forward-Looking Statement Safe Harbor Statement Under the Private Securities Litigation Act of 1995 -- With the exception of historical information, the matters discussed herein are forward-looking statements that involve a number of risks and uncertainties. The actual future results of Urigen could differ significantly from those statements. Factors that could cause actual results to differ materially include risks and uncertainties such as the inability to finance the company's operations or expansion, inability to hire and retain qualified personnel, changes in the general economic climate, including rising interest rate and unanticipated events such as terrorist activities. As with any new pharmaceutical product, there are significant risks in development, regulatory approval and commercialization of Urigen’s products. There are no guarantees that future clinical studies will confirm the preliminary results discussed in this document or that URG101, URG201 or URG301or any other Urigen product will receive regulatory approval for any medical condition. Further, even if Urigen were to receive regulatory approval for a product, there can be no assurance that such a product would prove to be commercially successful. In some cases, you can identify forward-looking statements by terminology such as "may," "will," "should," "expect," "plan," "anticipate," "believe," "estimate," "predict," "potential" or "continue," the negative of such terms, or other comparable terminology. These statements are only predictions. Although we believe that the expectations reflected in the forward-looking statements are reasonable, such statements should not be regarded as a representation by the Company, or any other person, that such forward-looking statements will be achieved. We undertake no duty to update any of the forward-looking statements, whether as a result of new information, future events or otherwise. In light of the foregoing, readers are cautioned not to place undue reliance on such forward-looking statements. For further risk factors see the risk factors associated with our Company, please review our SEC filings. 2 Urigen Pharmaceuticals, Inc.
Urigen - a Specialty Urology Company Clinical-stage urology products No new chemical entity (NCE) risk Substantial markets for unmet medical needs URG101 - Painful Bladder Syndrome/Interstitial Cystitis URG301 - Urethritis, Nocturia Experienced team Strong and expanding IP URG101 – Painful Bladder URG301 – Urethritis Urigen Pharmaceuticals, Inc.
Investor Attributes URG101 Double blind, placebo-controlled Phase II Study in Painful Bladder Syndrome/Interstitial Cystitis All End Points hit statistical significance Key Patent Issued 2008 (US Patent Protection to 2026) Extensive Safety Data Existing CPT Reimbursement Code Oceana Therapeutics Has First Right of Refusal on URG101 for 60 Days After Phase II FDA Meeting Seeking $12M Private Placement to Complete Development 4 Urigen Pharmaceuticals, Inc.
URG101 – Substantial Market & Paradigm Shift in Diagnosis & Therapy of PBS/IC • PBS/IC often misdiagnosed or co-morbid with other disorders e.g. OAB, UTIs, endometriosis, prostatitis • Overactive Bladder (OAB) - US Market ~17-33M • Urinary Tract Infections (UTI) - 8M UTI visits annually • Endometriosis – US Women ~5.5M • Significant Growth Prospects in an Underserved Market *Wu et al.,(2006) A retrospective claims database analysis to assess patterns of interstitial cystitis diagnosis 5 Urigen Pharmaceuticals, Inc.
Market Research Confirms PBS/IC Market Need • Life Science Strategy Group surveyed urologists and payors • Urologists “Very Likely” to prescribe URG101 for: • PBS/IC Flares • “Diagnostic” – Determine that Pain is from Bladder with first Tx • Rapid adoption of URG101 expected within 7 months • Payors Interviewed view URG101 favorably and will reimburse 100% Urigen Pharmaceuticals, Inc.
URG101 Product for the Treatment of PBS/IC • Combo Therapy with 2 Approved Drugs • Lidocaine and heparin • Simple in-office bladder instillation • Thousands of treatments by Founder • Product Advantages • Rapid Pain Relief • Easily assimilated into office practice • Existing CPT Reimbursement Code • Generation of significant extra income for Urologists and Gynecologists Urigen Pharmaceuticals, Inc.
Painful Bladder Syndrome - Interstitial Cystitis Market • Bladder Pain with Urgency & Frequency • Urine leaks through bladder wall triggering pain & urgency • No marketed product available for breakthrough symptoms • ~10.5M US & Canada • PBS/IC Market Poised For Growth • ’09 RAND Interstitial Cystitis Epidemiology study prevalence ~3-8M US women with IC • <50,000 Elmiron® scripts, but growing PBS/IC Bladder with visible damage Normal Bladder Urigen Pharmaceuticals, Inc.
URG101-104 Pharmacodynamic Study 10 Urigen Pharmaceuticals, Inc.
Time Course of Symptom Relief with One Dose 50% 11% n = 18 12
URG101-104 Study Met All Endpoints Urigen Pharmaceuticals, Inc.
Key Summary Findings • Immediate relief with first URG101 dose • Many patients experienced > 24hr symptom relief following only one dose. • Significant reduction of daytime symptoms • Many patients experienced fewer night time voiding episodes. Urigen Pharmaceuticals, Inc.
URG101 Intellectual Property • Patent licensed from UCSD • U.S. Patent 7,414,039covering the use of the composition of a local anesthetic, heparinoid and buffer for the treatment of symptoms of interstitial cystitis • Coverage to 2026 • Urigen patent application • Improved compositions for treatments • Pending in US, EU, other jurisdictions Urigen Pharmaceuticals, Inc.
Prof. Lowell Parsons Inventor of URG101 Inventor of Elmiron® #1 in license revenue for UCSD Sole Inventor on patent The standard of care Over 200 publications Over 30 years of PBS/IC research Former Chair of Urology at UCSD, Currently Full Professor Residency at Penn and Scientific Training at the NIH M.D., Yale University School of Medicine 15 Urigen Pharmaceuticals, Inc.
Corporate Governance:Board of Directors Lowell Parsons, MD -- Inventor of URG101 & Elmiron® ($170M Urology Drug) Michael Goldberg, MD -- Platinum-Montaur Life Sciences, LLC William J. Garner, MD -- President & CEO Martin Shmagin -- Chief Financial Officer Edward Teitel, MD,JD,MBA -- CEO, ThromboVision Robert Watkins -- ex-J&J 16 Urigen Pharmaceuticals, Inc.
URGP.OB Urigen Pharmaceuticals, Inc. 27 Maiden Lane, #595, San Francisco, CA 94108 (415) 781-0350 www.urigen.com 17