Palvella Therapeutics, Inc. · NASDAQ:PVLA

Palvella Therapeutics — Q3 2025 Earnings Presentation

19 slides from Palvella Therapeutics's earnings presentation, Nov 11, 2025

  1. Slide 1: First-in-disease therapies for patients with rare skin diseases

    First-in-disease therapies for patients with rare skin diseases Q3 2025 Financial Results & Corporate Update November 11, 2025 1

  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

  3. Slide 3: Building the leading rare disease biopharma company to address serious, rare skin diseases

    PALVELLA (pɑlʋelːɑ, Finnish): TO SERVE Building the leading rare disease biopharma company to address serious, rare skin diseases 3

  4. Slide 4: Multiple High-Impact Milestones By End of Q1 2026

    Multiple High-Impact Milestones By End of Q1 2026  SEPTEMBER 2025  NOVEMBER 2025 MID-DECEMBER 2025 Q1 2026 1 2 3 4 Third Planned Indication for New QTORIN Program: QTORIN Rapamycin: Phase 2 Top-line Data in Phase 3 Top-line Data in QTORIN Pitavastatin for Clinically Significant Cutaneous VMs Micro

  5. Slide 5: Advancing QTORIN Programs for Four Serious, Rare Skin Diseases and Beyond

    Advancing QTORIN Programs for Four Serious, Rare Skin Diseases and Beyond Continued Strong Momentum With Steady Cadence Of Key 2025 Milestones Achieved Anticipated Milestones Over Next 18 Months QTORIN Rapamycin Phase 3 SELVA trial ❑ Phase 3 SELVA ❑ Planned medical / ❑ NDA submission ❑ Potential FDA

  6. Slide 6: Clinical Programs

    QTORIN 3.9% RAPAMYCIN Clinical Programs 6

  7. Slide 7: Phase 2 TOIVA Study in cVMs: Full Enrollment Announced Sept '25

    Phase 2 TOIVA Study in cVMs: Full Enrollment Announced Sept ‘25 Single-arm, baseline-controlled, QD dose, age 6+, 12 weeks, n=16 Enrollment closed in Sept ’25 with n=16 patients Megha Tollefson, MD Principal Investigator No Statistical Hierarchy of Endpoints Safety o Safety and tolerability Efficacy

  8. Slide 8: QTORIN Rapamycin for Cutaneous Venous Malformations: Phase 2 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 Pha

  9. Slide 9: QTORIN Rapamycin for Microcystic Lymphatic Malformations

    QTORIN Rapamycin for Microcystic Lymphatic Malformations Q1 2026 • Potential to be first FDA-approved therapy • Phase 3 SELVA trial top-line data on track for Q1 2026 Phase 3 Top-line Data in Microcystic LMs • Received year two of FDA Orphan Drug Grant • Proceeds granted following FDA review of annu

  10. 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 = 5k Announced Targeting announcement September 2025 in 2026 and beyond 30k+ 75k+ 50k+ 200k+ Clinically Significant Additional Potential Futur

  11. Slide 11: Pipeline Programs

    QTORIN™ Pipeline Programs palvella THERAPEUTICS

  12. Slide 12: Clinically Significant Angiokeratomas: > 50k patients

    Clinically Significant Angiokeratomas: > 50k patients ESTIMATED DIAGNOSED IN THE U.S.1 Superficial Lymphatic Malformations Palvella’s focus to include Fordyce, Solitary, Mibelli, and Circumscriptum subtypes Chronically debilitating lymphatic-derived skin lesions associated with bleeding, pain, and f

  13. Slide 13: QTORIN Rapamycin as a "Pipeline-in-a-Product": Advancing Program to Angiokeratoma Patients

    QTORIN Rapamycin as a “Pipeline-in-a-Product”: Advancing Program to Angiokeratoma Patients FDA meeting planned 1H 2026 Leveraging established aspects • Discuss proposed Phase 2 study design of QTORIN rapamycin program • Longer-term, supplemental NDA (sNDA) submission planned (if approval achieved) i

  14. Slide 14: Disseminated Superficial Actinic Porokeratosis (DSAP): > 50k patients

    Disseminated Superficial Actinic Porokeratosis (DSAP): > 50k patients ESTIMATED DIAGNOSED IN THE U.S.1 Chronic, Pre-Cancerous, and Progressive Risk of malignant transformation: Premalignant disease with transformation to non-melanoma skin cancers2 Significant impact to quality of life: Genetics & Di

  15. 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 15 *HMGCR = 3-hydroxy-3-methylglutaryl-coenzyme A reductase. Image s

  16. Slide 16: QTORIN Pitavastatin Clinical Pathway: Planned Initiation of Phase 2 in 2H 2026

    QTORIN Pitavastatin Clinical Pathway: Planned Initiation of Phase 2 in 2H 2026 FDA meeting planned 1H 2026 QTORIN Pitavastatin: From Concept to Clinic • Discuss proposed Phase 2 study design • Discuss eligibility for expedited programs (Fast Track • QTORIN pitavastatin optimized for Designation) sta

  17. Slide 17: Finance

    Finance palvella THERAPEUTICS

  18. Slide 18: Q3 2025 Financial Highlights and 2025 Outlook

    Q3 2025 Financial Highlights and 2025 Outlook $63.6 million Runway into Cash at 9/30/2025 2H 2027 $10.2 million ~$55 million R&D + G&A spend in Q3 2025 Projected cash at year end 18

  19. Slide 19: Q&A

    Q&A Striving to be first for rare disease patients 19

Palvella Therapeutics — Q3 2025 Earnings Presentation on 6ix