Palvella Therapeutics, Inc. · NASDAQ:PVLA
Palvella Therapeutics — Q3 2025 Earnings Presentation
19 slides from Palvella Therapeutics's earnings presentation, Nov 10, 2025
Slide 1: Q3 2025 Financial Results & Corporate Update
First-in-disease therapies for patients with rare skin diseases Q3 2025 Financial Results & Corporate Update November 11, 2025 Exhibit 99.2
Slide 2: Forward Looking Statements
Forward Looking Statements This presentation contains forward-looking statements of Palvella Therapeutics, Inc. (the “Company”) within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include all statements that are not historical facts, and in some cas
Slide 3: Building the leading rare disease biopharma company
PALVELLA (pɑlʋelːɑ, Finnish): TO SERVE Building the leading rare disease biopharma company to address serious, rare skin diseases
Slide 4: Multiple High-Impact Milestones By End of Q1 2026
Multiple High-Impact Milestones By End of Q1 2026 SEPTEMBER 2025 NOVEMBER 2025 Serious, rare, no FDA-approved therapies Commercially attractive Third Planned Indication for QTORIN™ Rapamycin: Clinically Significant Angiokeratomas 1 Phase 2 Top-line Data in Cutaneous VMs 3 16 subjects MID-DECEMBER 20
Slide 5: Advancing QTORIN Programs for Four Serious, Rare Skin Diseases and Beyond
Advancing QTORIN™ Programs for Four Serious, Rare Skin Diseases and Beyond QTORIN™ Rapamycin Microcystic Lymphatic Malformations QTORIN™ Rapamycin Cutaneous Venous Malformations QTORIN™ Rapamycin Clinically Significant Angiokeratomas QTORIN™ Pitavastatin Disseminated Superficial Actinic Porokeratosi
Slide 6: QTORIN 3.9% Rapamycin Clinical Programs
QTORIN™ 3.9% RAPAMYCIN Clinical Programs
Slide 7: Phase 2 TOIVA Study in cVMs: Full Enrollment Announced
Phase 2 TOIVA Study in cVMs: Full Enrollment Announced Sept ‘25 Single-arm, baseline-controlled, QD dose, age 6+, 12 weeks, n=16 No Statistical Hierarchy of Endpoints Safety Safety and tolerability Efficacy Cutaneous venous malformation – investigators’ global assessment (7-point clinician change sc
Slide 8: QTORIN Rapamycin for Cutaneous Venous Malformations: TOIVA Study Objectives
QTORIN™ Rapamycin for Cutaneous Venous Malformations: Phase 2 TOIVA Study Objectives Safety Evaluating safety and tolerability compared to interventional and destructive approaches Efficacy Proof-of-concept study to detect one or more endpoints that could serve as the primary endpoint for Phase 3 st
Slide 9: QTORIN Rapamycin for Microcystic Lymphatic Malformations
QTORIN™ Rapamycin for Microcystic Lymphatic Malformations Phase 3 Top-line Data in Microcystic LMs EXCEEDED ENROLLMENT TARGET 51 subjects Q1 2026 Potential to be first FDA-approved therapy Phase 3 SELVA trial top-line data on track for Q1 2026 Received year two of FDA Orphan Drug Grant Proceeds gran
Slide 10: Growing Commercial Opportunity for QTORIN Rapamycin
Growing Commercial Opportunity for QTORIN™ Rapamycin: Pool of Addressable Patients in the U.S. Projected to Expand by >10x with Pipeline-in-a-Product Strategy 1. Lapa et al., Journal of Cutaneous Medicine and Surgery, (2025). Microcystic LMs Cutaneous VMs Clinically Significant Angiokeratomas Additi
Slide 11: QTORIN Pipeline Programs
QTORIN™ Pipeline Programs THERAPEUTICS
Slide 12: Clinically Significant Angiokeratomas: Superficial Lymphatic Malformations
> 50k patients ESTIMATED DIAGNOSED IN THE U.S.1 Clinically Significant Angiokeratomas: Superficial Lymphatic Malformations Persistent and extensive: Lesions can be large and increase in size, number, and extent over time Chronically debilitating lymphatic-derived skin lesions associated with bleedin
Slide 13: QTORIN Rapamycin as a Pipeline-in-a-Product: Angiokeratoma
QTORIN™ Rapamycin as a “Pipeline-in-a-Product”: Advancing Program to Angiokeratoma Patients FDA meeting planned 1H 2026 Discuss proposed Phase 2 study design Longer-term, supplemental NDA (sNDA) submission planned (if approval achieved) in microcystic LMs and/or cutaneous VMs Discuss eligibility for
Slide 14: Disseminated Superficial Actinic Porokeratosis (DSAP)
> 50k patients ESTIMATED DIAGNOSED IN THE U.S.1 Disseminated Superficial Actinic Porokeratosis (DSAP): Chronic, Pre-Cancerous, and Progressive Persistent and extensive: Clonal proliferation of abnormal keratinocytes leads to increased number and size of lesions Risk of malignant transformation: Prem
Slide 15: Clear Biology: Targeting the Causal Mevalonate Pathway
Clear Biology: Targeting the Causal Mevalonate Pathway Target: Mevalonate Pathway Tissue: Epidermis & Dermis Site of pathogenesis-directed therapy An on-target, in-tissue approach could result in significant clinical improvement *HMGCR = 3-hydroxy-3-methylglutaryl-coenzyme A reductase. Image sources
Slide 16: QTORIN Pitavastatin Clinical Pathway
QTORIN™ Pitavastatin Clinical Pathway: Planned Initiation of Phase 2 in 2H 2026 FDA meeting planned 1H 2026 Discuss proposed Phase 2 study design Discuss eligibility for expedited programs (Fast Track Designation) QTORIN™ Pitavastatin: From Concept to Clinic QTORIN™ pitavastatin optimized for stabil
Slide 17: Finance
Finance THERAPEUTICS
Slide 18: Q3 2025 Financial Highlights and 2025 Outlook
Q3 2025 Financial Highlights and 2025 Outlook $63.6 million Cash at 9/30/2025 Runway into 2H 2027 $10.2 million R&D + G&A spend in Q3 2025 ~$55 million Projected cash at year end
Slide 19: Q&A
Q&A Striving to be first for rare disease patients
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