Lipella Pharmaceuticals, Inc. · OTC:LIPO
Lipella Pharmaceuticals — Biotech Showcase 2023
19 slides from Lipella Pharmaceuticals's conference presentation, Feb 2, 2023
Slide 1: Liposomal Drug Delivery to Mucosal Surfaces
Biotech Showcase 2023 San Francisco, CA January 11, 2003 Liposomal Drug Delivery to Mucosal Surfaces 1
Slide 2: Disclaimers
Disclaimers The information in this presentation is being provided so you can familiarize yourself with Lipella Pharmaceuticals Inc. (together with its subsidiaries, “Lipella” the “Company,” “we,” “us,” or “our”) during this informational meeting. We request that you keep any information we provide
Slide 3: Executive Summary
Executive Summary Emerging, clinical-stage, proprietary 505(b)(2) opportunity Overview of Opportunity Drug-Delivery Focused Biotech 505(b)(2) Optimized for LP-10 is a phase-2a, 505(b)(2) drug candidate for epithelial tissues hemorrhagic cystitis Patented liposomal Lower systemic local drug delivery
Slide 4: Company History
Company History Born out of an NIH funded research collaboration on liposomal drug delivery to become a clinical-stage pharmaceutical company with a growing pipeline. 2005 2008 2012 2020 2021 2022 Jonathan Kaufman Michael Chancellor LP-10 FDA Orphan Platform patent Doug Johnston Initial Public co-fo
Slide 5: Hemorrhagic Cystitis, Uncontrolled Urinary Blood Loss
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 20% of such An increasing US Years after Hemorrhagic are increasingly patients receive popula
Slide 6: Cancer Survivorship & Hemorrhagic Cystitis
Cancer Survivorship & Hemorrhagic Cystitis Expected annual revenue per patient is $20,000 Market penetration of 60,000 patients (45%) yields $1.2 billion annual revenue The current phase-2a is focused on radiation cystitis. LP-10 is also expected to address hemorrhagic cystitis from chemotherapy. Pr
Slide 7: Stops Bleeding via Two Modes of Action
LP-10 Stops Bleeding via Two Modes of Action Tacrolimus’ molecular mechanism includes calmodulin mediated t-cell inhibition Reduce capillary Inhibits cytokine Increased efficacy blood flow cascade probability • LP-10 is a potent • LP-10 is a potent Well-known vasoconstrictor anti-inflammatory pharma
Slide 8: Product Form
LP-10 Product Form Liposomal tacrolimus treatment for hemorrhagic cystitis Sterile Easy powder to deliver Low COGS In-house CMC 8
Slide 9: Phase 2a Trial Design Summary
LP-10 Phase 2a Trial Design Summary Multi-center, dose-ranging study Details Refractory moderate-to-severe hemorrhagic Indication cystitis (HC) Dose ranging study to evaluate safety, Protocol design tolerability, and efficacy of LP-10 Subjects 12 Male and Female subjects from 5 sites Up to 2 instill
Slide 10: Phase 2a Trial Design Summary
LP-10 Phase 2a Trial Design Summary Key inclusion criteria: Key Exclusion criteria: 1. Males and females, at least 18 years 1. Patients taking immunosuppressive 2. History of sterile moderate to severe HC therapy (Grades 2-4) for at least 3 months with at 2. History of interstitial cystitis/bladder
Slide 11: Phase 2a Trial Design Summary
LP-10 Phase 2a Trial Design Summary Recruitment sites and subject disposition Patient Disposition Number Comments Screened, n 15 14 male, 1 female Enrolled, n 13 13 male 2 instillations (n=10) Number of instillations 23 1 instillation (n=3) Discontinued, % 0 Withdrew consent, % 0 Lack of compliance,
Slide 12: Phase 2a Trial Design Summary
LP-10 Phase 2a Trial Design Summary Patient Demographics 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 years 4 Range 1 -14 years medication, HBO, catheters, Prior H
Slide 13: Safety
LP-10 Safety Adverse events (AE) Number Comment Product related significant adverse events 0 Subject discontinuations 0 Number of subjects with adverse events 5/13 11 AEs reported in 5 subjects 2 mg: 3 AEs in 2 subjects 4 mg: 2 AEs in 1 subject 8 mg: 6 AEs in 2 subjects Bladder spasm, urinary urgenc
Slide 14: Pharmacokinetics and Safety
LP-10 Pharmacokinetics and Safety Local delivery of tacrolimus limits systemic distribution Subject Group baseline 1 hour 2 hours 4 hours 48 hours • < 1.5 ng/ml 1 2 mg - - 1.5 - - considered 2 2 mg - 2.3 - - -undetectable 3 2 mg - 3.0 1.7 - - 4 2 mg - 2.8 1.8 - - • All Levels were 5 4 mg - 4.8 1.8 -
Slide 15: Responder Analysis
LP-10 Responder Analysis Evaluating cystoscopy, hematuria, and symptoms (NR=“no response”, PR=“partial response”, CR=“complete response”) (normalized rank, 0 to 9) cystoscopy hematuria • Efficacy CR in all subjects symptoms improvement reported by principal 9 8 investigators, 7 patients and 6 labora
Slide 16: Phase 2a Trial Conclusion
LP-10 Phase 2a Trial Conclusion Trial Summary • LP-10 safety: • No Product related SAEs • Instillation procedure well tolerated by all subjects • LP-10 pharmacokinetic analysis demonstrated very short duration of systemic uptake • Signal of efficacy and dose response • Hematuria improved, decreased
Slide 17: Asset Pipeline and LP-310
Asset Pipeline and LP-310 LP-310: Liposomal tacrolimus for oral lichen planus Product Target Marketing Next Anticipated Candidate Indication Preclinical Phase 1 Phase 2 Phase 3 Approval Milestone Hemorrhagic FDA Meeting LP-10 Cystitis 3Q23 Oral Lichen IND submission LP-310 Planus 2Q23 Oral rinse for
Slide 18: Liposomal Drug Delivery to Mucosal Surfaces
Liposomal Drug Delivery to Mucosal Surfaces 18
Slide 19: Lipella Pharmaceuticals Inc.
Lipella Pharmaceuticals Inc. 7800 Susquehanna Street, Suite 505 Pittsburgh, PA 15208 412-894-1853 www.lipella.com 19