Lipella Pharmaceuticals, Inc. · OTC:LIPO
Lipella Pharmaceuticals — Investor Presentation (February 2024)
21 slides from Lipella Pharmaceuticals's investor presentation, February 2024
Slide 1: A Clinical Stage Biotechnology Company Addressing Serious Diseases with Significant Unmet Need
A Clinical Stage Biotechnology Company Addressing Serious Diseases with Significant Unmet Need NASDAQ:LIPO lipellapharmaceuticals.com
Slide 2: Disclaimers
NASDAQ:LIPO Disclaimers The information in this presentation is being provided so you can familiarize yourself with Lipella Pharmaceuticals Inc. (“Lipella,” the “Company,” “we,” “us,” or “our”) during this informational meeting. We request that you keep any information we provide at this meeting con
Slide 3: Mission
NASDAQ:LIPO Mission Lipella is committed to providing supportive care to cancer survivors. Our mission is to develop and commercialize treatments for serious diseases resulting from cancer treatments including radiation and chemotherapy. A Clinical Stage Biotechnology Company Addressing Serious Dise
Slide 4: Business Growth Strategy
NASDAQ:LIPO Business Why rare and orphan drugs? Growth • Lipella can be first to market by pursuing conditions for which there are no current FDA approved treatments. • Requires smaller and less costly drug trials with greater flexibility from the Strategy FDA. • Orphan drug market exclusivity limit
Slide 5: Overview of Opportunity
NASDAQ:LIPO Overview of Opportunity Drug Development Drug Delivery Lead product candidate, LP-10, a 505(b)(2) drug Proprietary drug delivery technology with candidate for hemorrhagic cystitis. potential applications in bladder, urethra, oral cavity, esophageal and colonic. LP-10 granted FDA Orphan D
Slide 6: Executive Summary
NASDAQ:LIPO Executive Summary Emerging, clinical-stage, proprietary 505(b)(2) opportunity Drug-Delivery Focused Biotech Impressive Revenue Potential Optimized for 505(b)(2) epithelial tissues $20,000 $1.2 billion annual revenue annual revenue Patented liposomal local drug delivery Lower systemic per
Slide 7: Cancer Survivorship and Potential Addressable Market
NASDAQ:LIPO Cancer Prostate Cancer Uterine Corpus Cancers Rectal & Other Pelvic Survivorship 700,0001 Pelvic Radiation Survivors 200,0001 Pelvic Radiation Survivors 300,0001 Pelvic Radiation Survivors and Potential 42,0002 12,0002 18,0002 Addressable Severe HC Survivors Severe HC Survivors Severe HC
Slide 8: Asset Pipeline
NASDAQ:LIPO Asset Pipeline A growing pipeline with strong patent protection Product Target Marketing Next Anticipated Preclinical Phase 1 Phase 2 Phase 3 Candidate Indication Approval Milestone FDA Type-D Hemorrhagic LP-10 mtg request Q1 Cystitis 2024 Phase-2a Oral Lichen Initiated. LP-310 Planus An
Slide 9: Hemorrhagic Cystitis, Uncontrolled Urinary Blood Loss
NASDAQ:LIPO Hemorrhagic Cystitis, Uncontrolled Urinary Blood Loss Hemorrhagic cystitis is a serious, life-threatening bladder damage from pelvic radiation therapy and/or bladder-toxic chemotherapy. Millions of patients are 20% of these patients An increasing US Years after receiving Hemorrhagic cyst
Slide 10: LP-10 for Hemorrhagic Cystitis
NASDAQ:LIPO LP-10 for Hemorrhagic Cystitis Liposomal tacrolimus treatment for hemorrhagic cystitis Potent vasoconstrictor; reduces capillary blood flow to the bladder lumen Sterile powder Potent anti-inflammatory; inhibits cytokine Easy to deliver cascade and reduces injury to the bladder tissue Low
Slide 11: LP-10: an Outstanding Drug Candidate
NASDAQ:LIPO LP-10: an Outstanding Drug Candidate Multiple reasons increase LP-10 probability of success • Well Known mechanism of Well known Potential 505(b)(2) action mechanism Ongoing $1.2 billion of action pathway revenue • Pre-clinical efficacy clinical evidence • 505(b)(2) pathway • Potential $
Slide 12: LP-10: Phase 2a Trial
NASDAQ:LIPO LP-10: Phase 2a Trial A Phase 2a clinical trial (NCT01393223): Top line results Next Steps • All subjects tolerated LP-10 • Type-C meeting with the FDA • Multi-center, dose-escalation instillations with no serious adverse completed Nov. 7, 2023 study events (SAE) reported • FDA approval
Slide 13: LP-10 Phase 2a Trial Patient Demographics
NASDAQ:LIPO LP-10 Phase 2a Age, years Mean 67 Comment Range 25-89 Trial Patient Race • White 9 Demographics • Non-White 4 Radiation induced HC 11 Chemotherapy induced HC 2 Cancer • Prostate cancer 9 • Bladder cancer 2 • Lymphoma 2 Duration of HC years 4 Range 1 -14 years medication, HBO, catheters,
Slide 14: LP-10 Safety
NASDAQ:LIPO Number Comment LP-10 Safety Product related significant adverse events 0 Subject discontinuations 0 Number of subjects with adverse events 6/13 12 AEs reported in 6 subjects Adverse events (AE) 2 mg: 4 AEs in 3 subjects 4 mg: 2 AEs in 1 subject 8 mg: 6 AEs in 2 subjects Bladder spasm, ur
Slide 15: Bleeding: Cystoscopy & Microscopy
NASDAQ:LIPO Bleeding: Cystoscopy & Microscopy A Clinical Stage Biotechnology Company Addressing Serious Diseases with Significant Unmet Need 15
Slide 16: LP-10 Phase 2b Trial Design
NASDAQ:LIPO LP-10 Phase 2b Trial Design Key criteria: Randomized, double-blind, placebo controlled , multi-center clinical trial of 36 Male and Female hemorrhagic cystitis patients, randomized 1:1:1 Subjects will be randomized into one of three groups: 2mg LP-10 , 4 mg LP-10 or Placebo Primary Effic
Slide 17: LP-310 for Oral Lichen Planus
NASDAQ:LIPO LP-310 for Oral Lichen Planus Oral Lichen Planus (OLP) is a chronic inflammatory, T-cell-mediated autoimmune oral mucosal disease • Painful and comes with the risk of complications including infections, scarring, stress and depression. • Has malignant potential. • Most currently availabl
Slide 18: Manufacturing Capabilities
NASDAQ:LIPO Manufacturing Capabilities • Lipella maintains a sterile manufacturing facility in Pittsburgh, PA for the production of clinical supplies and research products. • LP-10 has been produced at high quantities in this facility for Lipella's clinical trials. • The facility is also used for de
Slide 19: Experienced Management Team
NASDAQ:LIPO Experienced Management Team Lipella is led by an experienced team with complementary skillset and years of experience working together. Jonathan Kaufman, PhD Michael Chancellor, MD Chief Executive Officer Chief Medical Officer • 23+ Years Experience • 30+ Years Experience • Co-founded Li
Slide 20: Key Takeaways
NASDAQ:LIPO Key Takeaways Drug Development Drug Delivery Lead product candidate, LP-10, a 505(b)(2) drug candidate for Proprietary drug delivery technology with hemorrhagic cystitis. potential applications in bladder, urethra, oral cavity, esophageal and colonic. LP-10 granted FDA Orphan Drug Design
Slide 21: A Clinical Stage Biotechnology Company Addressing Serious Diseases with Significant Unmet Need
A Clinical Stage Biotechnology Company Addressing Serious Diseases with NASDAQ:LIPO Significant Unmet Need Lipella Pharmaceuticals Inc. 7800 Susquehanna Street, Suite 505 Pittsburgh, PA 15208 412-894-1853 lipellapharmaceuticals.com
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