Palvella Therapeutics, Inc. · NASDAQ:PVLA

Palvella Therapeutics — Q1 2025 Earnings Presentation

16 slides from Palvella Therapeutics's earnings presentation, May 15, 2025

  1. Slide 1: Q1 2025 Financial Results & Corporate Update

    First-in-disease therapies for patients with rare genetic skin diseases Q1 2025 Financial Results & Corporate Update May 15, 2025

  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 case

  3. Slide 3: Photo credit: Nasdaq, Inc./ Vanja Savic.

    Photo credit: Nasdaq, Inc./ Vanja Savic.

  4. Slide 4: Multiple High-Impact Milestones Over Next Quarters

    Multiple High-Impact Milestones Over Next 4 Quarters Phase 3 SELVA data in microcystic LMs (Q1:26) Phase 2 TOIVA data in cutaneous VMs (Q4:25) Additional mTOR-driven indication for QTORINTM Rapamycin (2H:25) New QTORINTM Program (2H:25) QTORINTM QTORINTM PLATFORM QTORINTM 3.9% rapamycin anhydrous ge

  5. Slide 5: Continued Strong Momentum at Palvella

    Continued Strong Momentum at Palvella QTORINTM rapamycin for microcystic LMs: Phase 3 SELVA trial Exceeded enrollment target of 40 patients; enrollment expected to close in June 2025 Top-line readout anticipated Q1 2026 Phase 2 TOIVA study on track in cutaneous VMs 6 sites open and enrolling Top-lin

  6. Slide 6: QTORIN 3.9% Rapamycin for Microcystic Lymphatic Malformations

    QTORINTM 3.9% RAPAMYCIN Microcystic Lymphatic Malformations FOR

  7. Slide 7: Phase 3 SELVA Enrollment Exceeded Target of 40 Patients

    Phase 3 SELVA Enrollment Exceeded Target of 40 Patients Single-arm, baseline-controlled, QD dose (Mike Kelly, MD, PhD) (Kiersten Ricci, MD) (Megha Tollefson, MD) (Sally Cohen-Cutler, MD) (Elizabeth Nieman, MD) (Ionela Iacobas, MD) (Andrea Zaenglein, MD) (Steve Kempers, MD) Enrollment expected to clo

  8. Slide 8: QTORIN Rapamycin for Treatment of mLMs: Regulatory Overview

    QTORINTM Rapamycin for Treatment of mLMs: Regulatory Overview Consistent and productive engagement with FDA on development program FDA Overview: Center: Center for Drug Evaluation Research (CDER) Division: Dermatology and Dentistry Division Leadership: Dr. Jill Lindstrom remains in Director role NDA

  9. Slide 9: QTORIN Rapamycin for Treatment of mLMs: Commercial Opportunity

    QTORINTM Rapamycin for Treatment of mLMs: Commercial Opportunity Est. Diagnosed U.S. Prevalence QTORINTM 3.9% rapamycin anhydrous gel is for investigational use only and has not been approved or cleared by the FDA or by any other regulatory agency. The safety or efficacy has not been established for

  10. Slide 10: ISSVA Conference 2025: April 23rd-25th in Paris, France

    ISSVA Conference 2025: April 23rd-25th in Paris, France Treatment paradigm rapidly evolving to targeted pharmacotherapy approaches, replacing surgery and sclerotherapy Off-label systemic agents, incl. oral PI3K inhibitors, introduce unacceptable side effects (e.g., growth retardation) for diseases t

  11. Slide 11: QTORIN 3.9% Rapamycin for Cutaneous Venous Malformations

    QTORINTM 3.9% RAPAMYCIN Cutaneous Venous Malformations FOR

  12. Slide 12: Phase 2 TOIVA Study in cVMs: Enrollment Ongoing

    Phase 2 TOIVA Study in cVMs: Enrollment Ongoing Single-arm, baseline-controlled, QD dose, age 6+, 12 weeks, n=~15 (Elizabeth Nieman, MD) Safety Safety and tolerability Efficacy Cutaneous venous malformation – investigators’ global assessment (7-point clinician change scale) Cutaneous venous malforma

  13. Slide 13: Key Value Drivers from Pipeline Programs in Second Half of 2025

    Key Value Drivers from Pipeline Programs in Second Half of 2025 Additional mTOR-driven indication for QTORINTM Rapamycin (2H:25) New QTORINTM Program (2H:25) QTORINTM QTORINTM PLATFORM QTORINTM 3.9% rapamycin anhydrous gel QTORINTM 3.9% rapamycin anhydrous gel is for investigational use only and has

  14. Slide 14: Financial Update

    Financial Update THERAPEUTIC

  15. Slide 15: Q1 2025 Financial Highlights and 2025 Outlook

    Q1 2025 Financial Highlights and 2025 Outlook 2+ years Runway into 2H 2027 $75.6 million Cash at 3/31/2025 $7.9 million R&D + G&A spend in Q1 2025 >$55 million Projected cash at year end Oversubscribed PIPE Financing (Dec. 2024) Strong Cash Position

  16. Slide 16: Q&A

    Q&A Striving to be first for rare disease patients

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