Lipella Pharmaceuticals, Inc. · OTC:LIPO
Lipella Pharmaceuticals — Investor Presentation (November 2024)
21 slides from Lipella Pharmaceuticals's investor presentation, November 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 Corporate Presentation November 2024 Jonathan Kaufman CEO and Co-founder NASDAQ:LIPO lipellapharmaceuticals.com
Slide 2: Disclaimers
NASDAQ:LIPO DISCLAIMERS T he information in this pres entation is being provided s o you can familiarize yours elf with Lipella P harmaceuticals Inc. (“Lipella,” the “C ompany,” “we,” “us ,” or “our”) during this informational meeting. We reques t that you keep any information we provide at this mee
Slide 3: About / Market Data
NASDAQ:LIPO ABOUT MARKET DATA Lipella P harmaceuticals is a clinical-s tage biotechnology company developing and SYMBOL NASDAQ: LIPO commercializing treatments for s erious dis eas es . P rice as of 8-19-2024 $0.41 Our proprietary drug delivery technology has 52 Week R ange $0.36 - $2.71 potential a
Slide 4: Business Growth Strategy
NASDAQ:LIPO BUSINESS GROWTH STRATEGY F ocus ed on rare and orphan drug indications , Lipella is leveraging the 505(b)(2) pathway. T his s trategy is expected to lower cos t and expedite the approval proces s . Why rare and orphan drugs? Why leverage the 505(b)(2) pathway? • Lipella can be firs t to
Slide 5: Investment Highlights
NASDAQ:LIPO INVESTMENT HIGHLIGHTS Attractive Market: T argeting two patient populations with s ignificant unmet needs and no current F DA approved drug treatments . Compelling Pipeline: T wo IND-approved lead as s ets in phas e 2 clinical trials , both 505(b)(2) drug candidates : • LP-10, a bladder
Slide 6: De-risked Lead Programs with Robust Revenue Opportunity
NASDAQ:LIPO DE - RISKED LEAD PROGRAMS WITH ROBUST REVENUE OPPORTUNITY 505(b)(2) drug candidates Positioned For Market Exclusivity LP-10 Lipos omal tacrolimus for the treatment of • Hemorrhagic cystitis affects ~60,000 annually Hemorrhagic cys titis . LP -10 has a well- • Expected annual revenue per
Slide 7: Differentiated Technology Platform: Liposomal Formulation of Tacrolimus
NASDAQ:LIPO DIFFERENTIATED TECHNOLOGY PLATFORM: Liposomal Formulation of Tacrolimus Maximizing Therapeutic Responses with Directed Localized Administration Optimized Efficacy B y encaps ulating tacrolimus in lipos omes , our technology ens ures a more s table and controlled releas e, maximizing ther
Slide 8: Near Term Catalysts
NASDAQ:LIPO NEAR TERM CATALYSTS Upcoming Proprietary Asset Pre-clinical IND-Enabling Phase 1 Phase 2 Phase 3 Milestones Anticipate FPI in 2H 2024, LP-10 Hemorrhagic C ys titis Study Completion in 2025 First 2 patients dosed , LP-310 O ral Lichen P lanus Data by YE 2024 H2 2024 H1 2025 H2 2025 • P at
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 thes e patients An increas ing US Y ears after receiving Hemorrhagic c
Slide 10: LP-10 for Hemorrhagic Cystitis (HC)
NASDAQ:LIPO LP - 10 FOR HEMORRHAGIC CYSTITIS (HC) Liposomal tacrolimus treatment for hemorrhagic cystitis • Potent vasoconstrictor; reduces Urgent Need For Effective HC Treatment Options capillary blood flow to the bladder lumen • Potent anti -inflammatory; inhibits cytokine • HC is challenging to t
Slide 11: LP-10: Phase 2a Trial
NASDAQ:LIPO LP - 10: PHASE 2A TRIAL A Phase 2a clinical trial Top line results Next Steps (NCT01393223): • Multi-center, dos e- • All s ubjects tolerated LP -10 • Initiate P has e 2b trial in es calation s tudy ins tillations with no s erious advers e LP -10 in 1H 2025 • 13 s ubjects with events (S
Slide 12: Oral Lichen Planus (OLP)
NASDAQ:LIPO ORAL LICHEN PLANUS (OLP) OLP is a chronic inflammatory, T -cell -mediated There is no current pharmacotherapy for oral lichen planus autoimmune oral mucosal disease Current OLP Treatments: P alliative with S ignificant S ide E ffects • Complications: P ain, weight los s , s tres s , depr
Slide 13: LP-310 (liposomal-tacrolimus) for Oral Lichen Planus
NASDAQ:LIPO LP-310 • S imilar formulation of LP -10 for oral rins e • Increas ed local concentration in oral cavity while minimalizing s ys temic toxicity (liposomal -tacrolimus) for • High s afety profile with no s ys temic toxicity Oral Lichen Planus obs erved • Low C O G S and fas t development p
Slide 14: LP-310 Clinical Snapshot
NASDAQ:LIPO LP - 310 CLINICAL SNAPSHOT Design : P ros pective multicenter dos e es calation s tudy with 24 patients . Efficacy : Anticipate a s tatis tically s ignificant decreas e in oral lichen planus les ion s core within 1 week of adminis tration, maintained for at leas t 4 weeks . Quality of Li
Slide 15: Asset Pipeline
NASDAQ:LIPO ASSET PIPELINE A growing pipeline with strong patent protection Upcoming Proprietary Asset Pre-clinical IND-Enabling Phase 1 Phase 2 Phase 3 Milestones LP-10 Anticipate p hase 2b trial to hemorrhagic cys titis start in 1H 2025 LP-310 First 2 patients dosed , oral lichen planus Topline da
Slide 16: LP-410 for Oral Graft-Versus-Host Disease
NASDAQ:LIPO LP - 410 FOR ORAL GRAFT - VERSUS - HOST DISEASE Oral Graft-Versus-Host Disease (GVHD) is a clinical s yndrome where donor-derived immunocompetent T cells react agains t patient tis s ues directly or through exaggerated inflammatory res pons es following HC T . • G VHD is a major caus e o
Slide 17: LP-50 for Bladder Cancer
NASDAQ:LIPO LP - 50 FOR BLADDER CANCER Novel liposomal formulation of checkpoint inhibitors • Intraves ical formulation for local, intraves ical P D-1 (i.e. checkpoint) inhibition, intended for the treatment of non-mus cle invas ive bladder cancer (NMIB C ). • Intraves ical immunotherapy pres ents a
Slide 18: Manufacturing Capabilities
NASDAQ:LIPO MANUFACTURING CAPABILITIES • Lipella maintains a s terile manufacturing facility in P itts burgh, P A for the production of clinical s upplies and res earch products . • LP -10 has been produced at high quantities in this facility for Lipella's clinical trials . • T he facility is als o
Slide 19: Experienced Management Team
NASDAQ:LIPO EXPERIENCED MANAGEMENT TEAM Jonathan Kaufman, PhD Michael Chancellor, MD Doug Johnston, CPA Chief Executive Officer Chief Medical Officer Chief Financial Officer • 15+ Y ears E xperience • 23+ Y ears E xperience • 30+ Y ears E xperience • J ointed Lipella in 2021 • C o-founded Lipella in
Slide 20: Key Takeaways
NASDAQ:LIPO KEY TAKEAWAYS • B road portfolio of three promis ing IND-approved • T argeting multiple patient populations including: as s ets . • ~60,000 new diagnos es of hemorrhagic cys titis each year. • LP -10 and LP -410 granted F DA O rphan Drug Des ignation; pos itioned for multiple accelerated
Slide 21: Lipella Pharmaceuticals Contact
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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