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Corporate Presentation April 23, 2010 URGP.OB Urigen Pharmaceuticals, Inc. 27 Maiden Lane, Suite...

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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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Page 1: Corporate Presentation April 23, 2010 URGP.OB Urigen Pharmaceuticals, Inc. 27 Maiden Lane, Suite 595, San Francisco, CA 94108 415 781-0350 .

Corporate Presentation

April 23, 2010

URGP.OB

Urigen Pharmaceuticals, Inc.27 Maiden Lane, Suite 595, San Francisco, CA 94108

415 781-0350www.urigen.com

Page 2: Corporate Presentation April 23, 2010 URGP.OB Urigen Pharmaceuticals, Inc. 27 Maiden Lane, Suite 595, San Francisco, CA 94108 415 781-0350 .

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.

Page 3: Corporate Presentation April 23, 2010 URGP.OB Urigen Pharmaceuticals, Inc. 27 Maiden Lane, Suite 595, San Francisco, CA 94108 415 781-0350 .

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

Page 4: Corporate Presentation April 23, 2010 URGP.OB Urigen Pharmaceuticals, Inc. 27 Maiden Lane, Suite 595, San Francisco, CA 94108 415 781-0350 .

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

Page 5: Corporate Presentation April 23, 2010 URGP.OB Urigen Pharmaceuticals, Inc. 27 Maiden Lane, Suite 595, San Francisco, CA 94108 415 781-0350 .

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

Page 6: Corporate Presentation April 23, 2010 URGP.OB Urigen Pharmaceuticals, Inc. 27 Maiden Lane, Suite 595, San Francisco, CA 94108 415 781-0350 .

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

Page 7: Corporate Presentation April 23, 2010 URGP.OB Urigen Pharmaceuticals, Inc. 27 Maiden Lane, Suite 595, San Francisco, CA 94108 415 781-0350 .

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

Page 8: Corporate Presentation April 23, 2010 URGP.OB Urigen Pharmaceuticals, Inc. 27 Maiden Lane, Suite 595, San Francisco, CA 94108 415 781-0350 .

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

Page 9: Corporate Presentation April 23, 2010 URGP.OB Urigen Pharmaceuticals, Inc. 27 Maiden Lane, Suite 595, San Francisco, CA 94108 415 781-0350 .

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

Page 10: Corporate Presentation April 23, 2010 URGP.OB Urigen Pharmaceuticals, Inc. 27 Maiden Lane, Suite 595, San Francisco, CA 94108 415 781-0350 .

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%

Page 11: Corporate Presentation April 23, 2010 URGP.OB Urigen Pharmaceuticals, Inc. 27 Maiden Lane, Suite 595, San Francisco, CA 94108 415 781-0350 .

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

Page 12: Corporate Presentation April 23, 2010 URGP.OB Urigen Pharmaceuticals, Inc. 27 Maiden Lane, Suite 595, San Francisco, CA 94108 415 781-0350 .

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

Page 13: Corporate Presentation April 23, 2010 URGP.OB Urigen Pharmaceuticals, Inc. 27 Maiden Lane, Suite 595, San Francisco, CA 94108 415 781-0350 .

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

Page 14: Corporate Presentation April 23, 2010 URGP.OB Urigen Pharmaceuticals, Inc. 27 Maiden Lane, Suite 595, San Francisco, CA 94108 415 781-0350 .

Urigen Pharmaceuticals, Inc. 14Urigen Pharmaceuticals, Inc. 14

URG101-104

Pharmacodynamic Study

Page 15: Corporate Presentation April 23, 2010 URGP.OB Urigen Pharmaceuticals, Inc. 27 Maiden Lane, Suite 595, San Francisco, CA 94108 415 781-0350 .

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

Page 16: Corporate Presentation April 23, 2010 URGP.OB Urigen Pharmaceuticals, Inc. 27 Maiden Lane, Suite 595, San Francisco, CA 94108 415 781-0350 .

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

Page 17: Corporate Presentation April 23, 2010 URGP.OB Urigen Pharmaceuticals, Inc. 27 Maiden Lane, Suite 595, San Francisco, CA 94108 415 781-0350 .

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

Page 18: Corporate Presentation April 23, 2010 URGP.OB Urigen Pharmaceuticals, Inc. 27 Maiden Lane, Suite 595, San Francisco, CA 94108 415 781-0350 .

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

Page 19: Corporate Presentation April 23, 2010 URGP.OB Urigen Pharmaceuticals, Inc. 27 Maiden Lane, Suite 595, San Francisco, CA 94108 415 781-0350 .

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

Page 20: Corporate Presentation April 23, 2010 URGP.OB Urigen Pharmaceuticals, Inc. 27 Maiden Lane, Suite 595, San Francisco, CA 94108 415 781-0350 .

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

Page 21: Corporate Presentation April 23, 2010 URGP.OB Urigen Pharmaceuticals, Inc. 27 Maiden Lane, Suite 595, San Francisco, CA 94108 415 781-0350 .

Urigen Pharmaceuticals, Inc. 21

Overactive Bladder Program

Lidocaine female urethral suppository

Phase I Tolerability Targeted for Q4 2010 Healthy Volunteers Pain scale endpoints

Page 22: Corporate Presentation April 23, 2010 URGP.OB Urigen Pharmaceuticals, Inc. 27 Maiden Lane, Suite 595, San Francisco, CA 94108 415 781-0350 .

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

Page 23: Corporate Presentation April 23, 2010 URGP.OB Urigen Pharmaceuticals, Inc. 27 Maiden Lane, Suite 595, San Francisco, CA 94108 415 781-0350 .

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

Page 24: Corporate Presentation April 23, 2010 URGP.OB Urigen Pharmaceuticals, Inc. 27 Maiden Lane, Suite 595, San Francisco, CA 94108 415 781-0350 .

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

Page 25: Corporate Presentation April 23, 2010 URGP.OB Urigen Pharmaceuticals, Inc. 27 Maiden Lane, Suite 595, San Francisco, CA 94108 415 781-0350 .

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

Page 26: Corporate Presentation April 23, 2010 URGP.OB Urigen Pharmaceuticals, Inc. 27 Maiden Lane, Suite 595, San Francisco, CA 94108 415 781-0350 .

URGP.OBUrigen Pharmaceuticals, Inc.

27 Maiden Lane, #595, San Francisco, CA 94108

(415) 781-0350

www.urigen.com

26


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