Lipella Pharmaceuticals, Inc. · OTC:LIPO
Lipella Pharmaceuticals — Investor Presentation (September 2023)
25 slides from Lipella Pharmaceuticals's investor presentation, Sep 11, 2023
Slide 1: A Clinical Stage Biotechnology Company Addressing Serious Diseases
A Clinical Stage Biotechnology Company Addressing Serious Diseases with Significant Unmet Need NASDAQ:LIPO lipellapharmaceuticals.com
Slide 2: Disclaimers and Forward-Looking Statements
A Clinical Stage Biotechnology Company Addressing Serious Diseases with Significant Unmet Need NASDAQ:LIPO Disclaimers Theinformation inthispresentation isbeing provided soyoucanfamiliarize yourself with LipellaPharmaceuticals Inc.(“Lipella,”the“Company,” “we,” “us,” or“our”) during thisinformationa
Slide 3: Mission
A Clinical Stage Biotechnology Company Addressing Serious Diseases with Significant Unmet Need 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 inclu
Slide 4: Business Growth Strategy
NASDAQ:LIPO A Clinical Stage Biotechnology Company Addressing Serious Diseases with Significant Unmet Need Business Growth Strategy Focused on rare and orphan drug indications and leveraging the 505(b)(2) pathway. Lipella anticipates this strategy will lower cost and allow for a faster approval proc
Slide 5: About Lipella Pharmaceuticals
A Clinical Stage Biotechnology Company Addressing Serious Diseases with Significant Unmet Need NASDAQ:LIPO About Lipella Pharmaceuticals is a clinical-stage biotechnology company developing new drugs by reformulating active agents in existing generic drugs for serious diseases characterized by signi
Slide 6: Overview of Opportunity
NASDAQ:LIPO A Clinical Stage Biotechnology Company Addressing Serious Diseases with Significant Unmet Need Overview of Opportunity Drug Development 6 Drug Delivery Proprietary drug delivery technology with potential applications in bladder, urethra, oral cavity, esophageal and colonic. Designed for
Slide 7: Executive Summary
NASDAQ:LIPO A Clinical Stage Biotechnology Company Addressing Serious Diseases with Significant Unmet Need 7 Executive Summary Emerging, clinical -stage, proprietary 505(b)(2) opportunity Drug-Delivery Focused Biotech Impressive Revenue Potential Patented liposomal local drug delivery 505(b)(2) Opti
Slide 8: Cancer Survivorship and Potential Addressable Market
A Clinical Stage Biotechnology Company Addressing Serious Diseases with Significant Unmet Need NASDAQ:LIPO Prostate Cancer Cancer Survivorship and Potential Addressable Market Expected annual revenue per patient is $20,000 Market penetration of 60,000 patients (50%) yields $1.2 billionannual revenue
Slide 9: Asset Pipeline
NASDAQ:LIPO A Clinical Stage Biotechnology Company Addressing Serious Diseases with Significant Unmet Need Asset Pipeline LP-10: Liposomal tacrolimus for hemorrhagic cystitis Proprietary liposomal formulation being evaluated as a treatment for hemorrhagic cystitis. A growing pipeline with strong pat
Slide 10: Hemorrhagic Cystitis, Uncontrolled Urinary Blood Loss
A Clinical Stage Biotechnology Company Addressing Serious Diseases with Significant Unmet Need NASDAQ:LIPO Millions of patients are diagnosed each yearwith pelvic malignancies including prostate cancer, and cancers of the uterine corpus, requiring treatment. 20% of these patients receive pelvic radi
Slide 11: LP-10 for Hemorrhagic Cystitis
NASDAQ:LIPO A Clinical Stage Biotechnology Company Addressing Serious Diseases with Significant Unmet Need LP-10 for Hemorrhagic Cystitis Liposomal tacrolimus treatment for hemorrhagic cystitis Potent vasoconstrictor; reduces capillary blood flow to the bladder lumen Potent anti-inflammatory; inhibi
Slide 12: LP-10: an Outstanding Drug Candidate
A Clinical Stage Biotechnology Company Addressing Serious Diseases with Significant Unmet Need NASDAQ:LIPO • Well Known mechanism of action • Pre-clinical efficacy • 505(b)(2) pathway • Potential $1.2 billion revenue • US FDA IND approval • Accelerated path -way candidate • Patent protection secured
Slide 13: LP-10: Phase 2a Trial
NASDAQ:LIPO A Clinical Stage Biotechnology Company Addressing Serious Diseases with Significant Unmet Need • Multi-center, dose -escalation study • 13 subjects with moderate to severe refractory hemorrhagic cystitis • Subjects treated with up to two courses of LP-10 intravesical bladder instillation
Slide 14: LP-10 Phase 2a Trial Patient Demographics
NASDAQ:LIPO A Clinical Stage Biotechnology Company Addressing Serious Diseases with Significant Unmet Need Mean Comment Age, years 67 Range 25-89 Race • White 9 • Non-White 4 Radiation induced HC 11 Chemotherapy induced HC 2 Cancer • Prostate cancer 9 • Bladder cancer 2 • Lymphoma 2 Duration of HC y
Slide 15: LP-10 Safety: Adverse Events
NASDAQ:LIPO A Clinical Stage Biotechnology Company Addressing Serious Diseases with Significant Unmet Need Number Comment Product related significant adverse events 0 Subject discontinuations 0 Number of subjects with adverse events 6/13 12 AEs reported in 6 subjects 2 mg: 4 AEs in 3 subjects 4 mg:
Slide 16: Bleeding: Cystoscopy & Microscopy
A Clinical Stage Biotechnology Company Addressing Serious Diseases with Significant Unmet Need NASDAQ:LIPO 16 Bleeding: Cystoscopy & Microscopy
Slide 17: Hematuria & Incontinence
A Clinical Stage Biotechnology Company Addressing Serious Diseases with Significant Unmet Need NASDAQ:LIPO 17 Hematuria & Incontinence
Slide 18: Dose Response: Bleeding by Cystoscopy
A Clinical Stage Biotechnology Company Addressing Serious Diseases with Significant Unmet Need NASDAQ:LIPO 18 Dose Response: Bleeding by Cystoscopy
Slide 19: Dose Response: Urinary Urge Incontinence
A Clinical Stage Biotechnology Company Addressing Serious Diseases with Significant Unmet Need NASDAQ:LIPO 19 Dose Response: Urinary Urge Incontinence
Slide 20: LP-10 Phase 2b Trial Design
A Clinical Stage Biotechnology Company Addressing Serious Diseases with Significant Unmet Need NASDAQ:LIPO 20 LP-10 Phase 2b Trial Design 40 HC subjects randomized 50:50 LP-10 therapy two courses Delayed- treatment Cystoscopy at baseline Cystoscopy at week 4 Cystoscopy at week 4 LP-10 therapy two co
Slide 21: LP-310 for Oral Lichen Planus
A Clinical Stage Biotechnology Company Addressing Serious Diseases with Significant Unmet Need NASDAQ:LIPO • Painful and comes with the risk of complications including infections, scarring, stress and depression. • Has malignant potential. • Most currently available therapies are palliative rather t
Slide 22: Manufacturing Capabilities
NASDAQ:LIPO A Clinical Stage Biotechnology Company Addressing Serious Diseases with Significant Unmet Need • Lipellamaintains 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 facilit
Slide 23: Experienced Management Team
A Clinical Stage Biotechnology Company Addressing Serious Diseases with Significant Unmet Need NASDAQ:LIPO Experienced Management Team Lipella is led by an experienced team with complementary skillset and years of experience working together. Jonathan Kaufman, PhD Chief Executive Officer • 23+ Years
Slide 24: Key Takeaways
NASDAQ:LIPO A Clinical Stage Biotechnology Company Addressing Serious Diseases with Significant Unmet Need 24 Key Takeaways Drug Development Drug Delivery Proprietary drug delivery technology with potential applications in bladder, urethra, oral cavity, esophageal and colonic. Designed for use with
Slide 25: Contact
A Clinical Stage Biotechnology Company Addressing Serious Diseases with Significant Unmet Need NASDAQ:LIPO lipellapharmaceuticals.com LipellaPharmaceuticals Inc. 7800 Susquehanna Street, Suite 505 Pittsburgh, PA 15208 412-894-1853
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