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Corporate Presentation
April 23, 2010
URGP.OB
Urigen Pharmaceuticals, Inc.27 Maiden Lane, Suite 595, San Francisco, CA 94108
415 781-0350www.urigen.com
Urigen Pharmaceuticals, Inc. 2Urigen Pharmaceuticals, Inc. 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.
Urigen Pharmaceuticals, Inc. 3Urigen Pharmaceuticals, Inc. 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
Urigen Pharmaceuticals, Inc. 4Urigen Pharmaceuticals, Inc. 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
5Urigen 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
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
Urigen Pharmaceuticals, Inc. 7
PBS/IC Market Gaining Pharma Attention
Trial StatusAllergan AGN203818 Suspended in Phase II
NIDDK/Roche Cellcept® Terminated
MediciNova MN001 Suspended in Phase II/III
Astellas IPD1151D Phase II US & EU
Pfizer PF04383119Pfizer PD0299685 Plethora PSD597
Phase II US – injectable anti-NGF AbPhase II US – oral (pregabalin)Phase II US – instilled anesthetic only
7
Urigen Pharmaceuticals, Inc. 8Urigen Pharmaceuticals, Inc. 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
Urigen Pharmaceuticals, Inc. 9Urigen Pharmaceuticals, Inc. 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
Urigen Pharmaceuticals, Inc. 10Urigen 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%
Urigen Pharmaceuticals, Inc. 11Urigen 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
Urigen Pharmaceuticals, Inc. 12Urigen 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
Urigen Pharmaceuticals, Inc. 13Urigen 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
Urigen Pharmaceuticals, Inc. 14Urigen Pharmaceuticals, Inc. 14
URG101-104
Pharmacodynamic Study
Urigen Pharmaceuticals, Inc. 15
Time Course of Symptom Relief with
One Dose
50%
11%
n = 18
% Change in Pain over Time
-50
-40
-30
-20
-10
0
0 1 2 3 4 5 6 7 8 9 10 11 12
Time (hours)
% C
ha
ng
e in
Pa
in
Urigen Pharmaceuticals, Inc. 16Urigen Pharmaceuticals, Inc. 16
URG101-104 Study Met All Endpoints
Endpoint Symptom P Value
Primary Endpoint
% Improvement Ave Daytime Pain Pain 0.036
Secondary Endpoints
PORIS Question 3 (0.5hr) Pain/Urgency 0.014
% Improvement Ave Daytime Urge Urgency 0.033
% Improvement Ave Total Symptom Score
Pain/Urgency 0.032
Urigen Pharmaceuticals, Inc. 17
Key Summary Findings
Immediate relief with first URG101 doseMany patients experienced > 24hr symptom relief
following only one dose.Significant reduction of daytime symptomsMany patients experienced fewer night time voiding
episodes.
Urigen Pharmaceuticals, Inc. 17
Urigen Pharmaceuticals, Inc. 18Urigen 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
Urigen Pharmaceuticals, Inc. 19
Overactive Bladder
URG301: buffered lidocaine urethral suppositoryOccupies ~ 65% of the female urethraMelts promptly upon insertionDistributes the drug to the urethral and bladder tissues Achieves rapid anesthetic effectCalms pain and urgency Two issued patents
URG301
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
Urigen Pharmaceuticals, Inc. 21
Overactive Bladder Program
Lidocaine female urethral suppository
Phase I Tolerability Targeted for Q4 2010 Healthy Volunteers Pain scale endpoints
Urigen Pharmaceuticals, Inc. 22Urigen 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
Urigen Pharmaceuticals, Inc. 23
URG101 Revenue Projection
23
$0
$50,000,000
$100,000,000
$150,000,000
$200,000,000
$250,000,000
$300,000,000
$350,000,000
$400,000,000
$450,000,000
Gynecologists
Urologists
Gynecologists $74,846,247 $129,933,666 $181,207,059 $233,056,318 $281,274,121 $355,551,551 $425,980,304
Urologists $28,523,398 $42,211,465 $54,830,598 $67,465,033 $79,035,930 $98,468,800 $117,004,847
Year 1 Year 2 Year 3 Year 4 Year 5 Year 6 Year 7
Source: Physician interviews; Navigant Consulting, Inc. 2006
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
Urigen Pharmaceuticals, Inc. 25Urigen 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
URGP.OBUrigen Pharmaceuticals, Inc.
27 Maiden Lane, #595, San Francisco, CA 94108
(415) 781-0350
www.urigen.com
26