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Corporate Presentation April 23, 2010 URGP.OB Urigen Pharmaceuticals, Inc. 27 Maiden Lane, Suite 595, San Francisco, CA 94108 415 781-0350 www.urigen.com
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Urigen Pharmaceuticals, Inc. 2 2 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 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.
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Urigen Pharmaceuticals, Inc. 3 3 Lowell Parsons, MD Inventor of URG101 Inventor of Elmiron ® #1 in license revenue for UCSD Sole Inventor on patent The standard of care About 250 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
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Urigen Pharmaceuticals, Inc. 4 4 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 URG301 – Urethritis URG101 – Painful Bladder
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5 Urigen Pharmaceuticals, Inc. 3. Muscle Tissue – Effects Urination Detrusor muscle spasms. Frequent urination Painful Bladder Syndrome/Interstitial Cystitis 1. Urine Contains Toxins, Electrolytes (Including K + ) Can damage exposed urothelium & activate nerves 2. Mucin Protects Urothelium Loss of sulfated polysaccharide mucin layer results in damage to urothelium and loss of protection to bladder detrusor and nerves 4. Sensory Neurons – Monitor Bladder Status Pain, urinary urgency and muscle spasms occur via electrolytes and toxins
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Urigen Pharmaceuticals, Inc. 6 URG101 – Substantial Market & Paradigm Shift in Diagnosis & Therapy of PBS/IC Urigen Pharmaceuticals, Inc. 6 PBS/IC often misdiagnosed as other disorders e.g. OAB, UTIs, endometriosis, prostatitis Overactive Bladder (OAB) - US Market ~17-33M Urinary Tract Infections (UTI) - 8M 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
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Urigen Pharmaceuticals, Inc. 7 PBS/IC Market Gaining Pharma Attention TrialStatus Allergan AGN203818Suspended in Phase II NIDDK/Roche Cellcept ® Terminated MediciNova MN001Suspended in Phase II/III Astellas IPD1151DPhase II US & EU Pfizer PF04383119 Pfizer PD0299685 Plethora PSD597 Phase II US – injectable anti-NGF Ab Phase II US – oral (pregabalin) Phase II US – instilled anesthetic only 7
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Urigen Pharmaceuticals, Inc. 8 8 URG101 Product for the Treatment of PBS/IC Lidocaine and heparin Product Advantages Rapid Pain Relief Easily assimilated into office practice Existing CPT Reimbursement Code Generation of significant extra income for Urologists and Gynecologists
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Urigen Pharmaceuticals, Inc. 9 9 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
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Urigen Pharmaceuticals, Inc. 10 Urigen Pharmaceuticals, Inc. 10 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” – Determines that Pain is from Bladder with first treatment Rapid adoption of URG101 expected within 7 months Payors Interviewed view URG101 favorably and will reimburse 100%
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Urigen Pharmaceuticals, Inc. 11 Urigen Pharmaceuticals, Inc. 11 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 Normal Bladder PBS/IC Bladder with visible damage
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Urigen Pharmaceuticals, Inc. 12 Urigen Pharmaceuticals, Inc. 12 URG101 Provides Rapid Relief for Symptom Flares Last drug approved in 1997 Elmiron ® (J&J) 3-6 Months for Effect Three times per day Oral capsules Artificial heparinoid URG101 Effect within Minutes Two/three per Flare Instillation (MD Revenue) Heparin-lidocaine formulation URG101 Comparison to Market Leader
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Urigen Pharmaceuticals, Inc. 13 Urigen Pharmaceuticals, Inc. 13 Partnering Opportunity URG101 for Painful Bladder Syndrome Completed Positive Phase II study Filed for FDA Meeting on April 22, 2010 ~$10M - $12M cost to NDA filing Existing reimbursement code (CPT) Peak sales est. $500M* US Patent protection to 2026 * Life Science Strategy Group
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Urigen Pharmaceuticals, Inc. 14 Urigen Pharmaceuticals, Inc. 14 URG101-104 Pharmacodynamic Study
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Urigen Pharmaceuticals, Inc. 15 Time Course of Symptom Relief with One Dose 50% 11% n = 18
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Urigen Pharmaceuticals, Inc. 16 Urigen Pharmaceuticals, Inc. 16 URG101-104 Study Met All Endpoints EndpointSymptomP Value Primary Endpoint % Improvement Ave Daytime PainPain0.036 Secondary Endpoints PORIS Question 3 (0.5hr)Pain/Urgency0.014 % Improvement Ave Daytime UrgeUrgency0.033 % Improvement Ave Total Symptom Score Pain/Urgency0.032
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Urigen Pharmaceuticals, Inc. 17 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. 17
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Urigen Pharmaceuticals, Inc. 18 Urigen Pharmaceuticals, Inc. 18 URG101 Intellectual Property 1.Patent licensed from UCSD U.S. Patent 7,414,039 covering the use of the composition of a local anesthetic, heparinoid and buffer for the treatment of symptoms of interstitial cystitis Coverage to 2026 2.Urigen patent application Improved compositions for treatments Pending in US, EU, other jurisdictions
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Urigen Pharmaceuticals, Inc. 19 Overactive Bladder URG301: buffered lidocaine urethral suppository Occupies ~ 65% of the female urethra Melts promptly upon insertion Distributes the drug to the urethral and bladder tissues Achieves rapid anesthetic effect Calms pain and urgency Two issued patents URG301
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Urigen Pharmaceuticals, Inc. 20 Overactive Bladder Market Overview Unsatisfied Market Afflicts at least 16 million American women* Under-reported, under-treated 4 million ‘drop outs’ in 2006: 90% at 11 months** Characterized By: Relentless urge and frequency to ‘go’ Reduced social mobility/sleep interruption Current Medications Reduce frequency by ‘one’ event in 24 hours Significant frequency of bothersome side effects None provide sleep or social relief *Mayo Clin Proc 2001; 76:358-363; **IMS 2006 Prescription Data
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Urigen Pharmaceuticals, Inc. 21 Overactive Bladder Program Lidocaine female urethral suppository Phase I Tolerability Targeted for Q4 2010 Healthy Volunteers Pain scale endpoints
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Urigen Pharmaceuticals, Inc. 22 Urigen Pharmaceuticals, Inc. 22 Board of Directors C. Lowell Parsons, MD – Inventor of URG101 & Elmiron ® ($170M Urology Drug) Michael M. Goldberg, MD – Platinum-Montaur Life Sciences, LLC William J. Garner, MD – President & CEO Martin E. Shmagin – Chief Financial Officer Edward R. Teitel, MD,JD,MBA – CEO, ThromboVision, Inc. Dan B. Vickery, Ph.D. – President, BioEnsemble, Ltd. Robert J. Watkins, RJ Watkins & Company – ex-J&J
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Urigen Pharmaceuticals, Inc. 23 URG101 Revenue Projection 23 Source: Physician interviews; Navigant Consulting, Inc. 2006
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Urigen Pharmaceuticals, Inc. 24 Capital Structure OTC BB: URGP 151,535 Average Daily Volume $0.19 52 week high $0.05 52 week low $12.96M Market Cap *88,733,194 common shares outstanding 210 convertible preferred shares outstanding that convert to 21,000,000 common shares 17,260,790 warrants that convert at $0.125 5,524,410 convertible preferred shares outstanding that convert to 5,529,410 33.19% Insider ownership 24 *Includes 2.5M to be issued
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Urigen Pharmaceuticals, Inc. 25 Urigen Pharmaceuticals, Inc. 25 Current Status URG101 FDA meeting filed April 22, 2010 (Phase II met all endpoints) Strengthen Balance Sheet For Tier 1 Partnerships URG301 Phase I Tolerability Study
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URGP.OB Urigen Pharmaceuticals, Inc. 27 Maiden Lane, #595, San Francisco, CA 94108 (415) 781-0350 www.urigen.com 26
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