Lipella Pharmaceuticals, Inc. · OTC:LIPO
Lipella Pharmaceuticals — Investor Presentation (September 2025)
29 slides from Lipella Pharmaceuticals's investor presentation, Sep 18, 2025
Slide 1: Corporate Presentation September 2025
1 lipellapharmaceuticals.com A Clinical Stage Biotechnology Company Transforming Care with Innovative Mucosal Delivery Solutions Corporate Presentation September 2025
Slide 2: Disclaimers
2 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 confident
Slide 3: Experienced Management Team
3 Experienced Management Team Jonathan Kaufman, PhD Chief Executive Officer Michael Chancellor, MD Chief Medical Officer Doug Johnston, CPA Chief Financial Officer 23+ Years Experience Co - founded Lipella in 2005 Co - founder of Knopp Biosciences. CFO of Semprus Biosciences. CSO LaunchCyte LLC. PhD
Slide 4: Value of Liposomal Delivery
4 Value of Liposomal Delivery Improved Mucosal Adhesion and Retention Liposomes adhere to oral mucosa and prolong drug residence time vs. standard rinses and ointments Enhanced local drug availability translates to more consistent symptom control Minimal Systemic Exposure Liposomal encapsulation slo
Slide 5: Strategic Focus on 505(b)(2) Pathway and Orphan Drug Indications
5 Lipella’s Strategic Focus is on the Accelerated 505(b)(2) Pathway and Orphan Drug Indications Advantages of the 505(b)(2) pathway Accelerated Development : Enables Phase 2 initiation without Phase 1 by leveraging existing safety data Validated Compounds : Builds on well - characterized compounds w
Slide 6: Company Pipeline
6 Company Pipeline Proprietary Asset Pre - clinical IND - Enabling Phase 1 Phase 2 Phase 3 LP - 10 (oral rinse) (previously LP - 310) LP - 10 (intravesical) LP - 10 (oral rinse) (previously LP - 410 ) LP - 50 (intravesical) Oral Lichen Planus (OLP) Hemorrhagic Cystitis (HC) Bladder Cancer Oral GvHD
Slide 7: OLP is a Painful, Autoimmune Disorder of the Oral Cavity
7 • Appearance : Lacy, white, raised patches; red, swollen, tender areas; open sores • Who it affects : Women are affected more often than men (2:1 female - to - male ratio), with onset typically occurring between ages 30 - 60 • Location : Found inside cheeks, gums, tongue, lips, and palate • Sympto
Slide 8: Current Treatments
8 Current Treatments Disease Severity Examples Dosage form Use Case Key Limitation Topical Corticosteroids Mild to Moderate Clobetasol, Fluocinolide , dexamethasone rinse Creams, ointments, gels First line, localized symptomatic OLP Local Corticosteroid Use Limited by Safety & Tolerability Issues Or
Slide 9: Oral Rinse for Oral Lichen Planus
9 LP - 10 (Oral Rinse) (liposomal - tacrolimus) for Oral Lichen Planus
Slide 10: Tacrolimus: Well-Established Potent Immunomodulator
10 Tacrolimus reduces T - cell activation in the oral mucosa by inhibiting calcineurin LP - 10 LP - 10 Tacrolimus Has a Well - Established Track Record as a Potent Immunomodulator https:// www.researchgate.net /publication/301645225/figure/fig1/AS:355120102559744@1461678638185/Mechanism - of - actio
Slide 11: Oral Rinse is Advancing the Standard of Care in OLP
11 LP - 10 (Oral Rinse) is Advancing the Standard of Care in OLP LP - 10 Unique Profile Liposomal tacrolimus formulation with enhanced mucosal penetration and targeted anti - inflammatory effects for oral lichen planus (OLP) and oral Graft - versus - Host Disease (GVHD) Safety Advantage Blood levels
Slide 12: Favorable Systemic PK Profile
12 Minimal systemic exposure: Tacrolimus was undetectable (<1.0 ng/mL) in 76% of blood samples (81/106), confirming localized drug delivery. Low measurable levels: Among 27 patients monitored at multiple timepoints, only 25 measurements exceeded 1.0 ng/mL; highest value was 4.5 ng/mL, well below the
Slide 13: Phase 2a Results
13 PHASE 2A RESULTS
Slide 14: Patient Demographics
14 Patient Demographics Objective: Evaluate safety, tolerability, and preliminary efficacy of LP - 10 oral rinse in patients with symptomatic OLP Design: Multicenter dose - escalation trial Population: Adults with biopsy - confirmed symptomatic OLP Regimen: Twice - daily oral rinse (10 mL) for 4 wee
Slide 15: Study Overview
15 Study Overview M ulticenter dose - ranging study in adult male and female subjects aged ≥18 years with symptomatic OLP designed to evaluate the safety, tolerability, and preliminary efficacy of LP - 10 at dose levels of 0.25 mg, 0.5 mg, and 1.0 mg of tacrolimus. 27 subjects enrolled at 7 study si
Slide 16: Comprehensive OLP Clinical Endpoints
16 Validated Clinical / Lesion Severity Scales Validated Symptom / Pain Scales Comprehensive Oral Lichen Planus (OLP) Clinical Endpoints OLP Investigator Global Assessment (IGA)¹ • Investigator - rated assessment of OLP ulceration and erythema • Score range: 0 = clear, 4 = severe Reticulation, Eryth
Slide 17: Inclusions and Exclusions
17 Moderate OLP based on an OLP Investigator Global Assessment (IGA) score of ≥ 3 OLP Pain or Sensitivity Numerical Rating Scale (NRS) score of ≥ 3 Oral biopsy performed within the last 10 years before the Screening Visit demonstrating OLP and/or oral lichenoid mucositis i n t he absence of cancer o
Slide 18: Well Tolerated Across All Dose Groups
18 * Not reported means not > 5% incidence LP - 10 (Oral Rinse): Well Tolerated Across All Dose Groups with No Serious AEs or Discontinuation - Related AE’s Key Safety Findings Excellent safety profile with NO serious adverse events and minimal systemic absorption (76% undetectable blood tacrolimus
Slide 19: Key Clinical Responses: IGA and REU in OLP
19 *p<0.0009, **p<0.0001, significant decline in IGA score from baseline (week 0); Mixed - effects model by Tukey’s test. Mean SEM 0 1 4 6 0 2 4 Week O L P I G A 0.25mg 0.5mg 1mg ** ** * * * * *p<0.0001, significant decline in REU score from baseline (week 0); REU score range up to 40; baseline REU
Slide 20: Statistically Significant Pain and Sensitivity Improvement
20 Patient Reported Pain Reduction (0 - 10 Scale) Patient Reported Sensitivity Reduction (0 - 10 Scale) 0 1 4 6 0 2 4 6 8 Week P a i n s c o r e 0.25mg 0.5mg 1mg * *p<0.0001,significant decline in pain score (0 - 10) from baseline (week 0); repeated measures ANOVA (Mixed - effects model) followed by
Slide 21: Positive Treatment Outcomes Demonstrated by OLPSSM
21 0 1 4 6 0 5 10 15 Week O L P S S M # 1 - 7 0.25mg 0.5mg 1mg * ** *<p<0.0003; **p<0.0001, significant decline in OLPSSM #1 - 7 from baseline (week 0); Repeated measures ANOVA (Mixed - effects model) followed by Tukey’s test vs Baseline (week 0) ** Positive Treatment Outcomes Demonstrated by OLPSSM
Slide 22: Global Response Assessment
22 Very much better No Change Very much worse As compared to when you started the study, how would you rate your overall quality of life now? 6= Very much better 5= Moderately better 4= A little better 3=No change 2= A little worse 1= Moderately worse 0= Very much worse 0 . 2 5 m g 0 . 5 m g 1 m g 0
Slide 23: Clinician & Patient Voices
23 Clinician & Patient Voices Validate LP - 10’s Impact Testimonials from Healthcare professionals and patients Clinician Voices Most significant advancement in OLP treatment in my career.” - Alessandro Villa, DDS, PhD, MPH, Miami Cancer Institute “Liposomal delivery is a genuine breakthrough for or
Slide 24: Investment Highlights
24 LP - 10 (Oral Rinse) Investment Highlights
Slide 25: Patient Population Dynamics
25 Patient Population Dynamics LP - 10 Addressable Patient Population Accounting for a modest diagnosis rate, symptomatic disease, and patients inadequately controlled on frontline corticosteroid s, the peak addressable population for LP - 10 is projected to be ~1.2 M Sources: LifeSci Consulting Pri
Slide 26: Physician Reported Unmet Needs and Opportunity
26 Physician Reported Unmet Needs and LP - 10 Opportunity First FDA Approved Therapy Improved Awareness Safe Chronic Management • Topical steroids are limited to short courses; systemic use restricted to flares • Immunosuppressants control refractory disease but require monitoring, limiting routine
Slide 27: Pricing and Access Dynamics
27 LP - 10 Pricing and Access Dynamics Sources: LifeSci Consulting Primary Market Research (N=15 U.S. HCPs, 5 U.S. Payers) Payer Monthly WAC Price Expectations for LP - 10 $200 $800 $1,000 $1,500 $2,000 $3,000 $500 Payers cite ~$1 K as the most reasonable benchmark for LP - 10, though standard brand
Slide 28: Investment Highlights
28 Experienced Team Strategic Manufacturing Capabilities Investment Highlights Focused on rare and orphan indications, leveraging the 505(b)(2) pathway to reduce costs and accelerate time to approval. Liposomal tacrolimus (LP - 10) • (LP - 10 Oral - rinse) for Oral Lichen Planus (OLP): Positive Ph2a
Slide 29: Thank you!!
29 Thank you!! lipellapharmaceuticals.com
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