Palvella Therapeutics, Inc. · NASDAQ:PVLA
Palvella Therapeutics — Q2 2026 Earnings Presentation
25 slides from Palvella Therapeutics's earnings presentation, Aug 4, 2026
Slide 1: Q2 2026 Financial Results & Corporate Update
First-in-disease therapies for patients with rare diseases Q2 2026 Financial Results & Corporate Update August 4, 2026
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: Leadership in Addressing Rare Skin Diseases and Vascular Malformations
Leadership in Addressing Rare Skin Diseases and Vascular Malformations: Late-stage Pipeline and QTORIN™ Platform Completed Pre-NDA meeting with FDA; granted rolling review Positive Phase 2 data; Phase 3 study initiation on track for Q4 2026 First module of NDA submitted; completion of submission on
Slide 4: Driving the Next Wave of Innovation in Under-Appreciated Rare Skin Diseases
Palvella: Driving the Next Wave of Innovation in Under-Appreciated Rare Skin Diseases and Vascular Malformations 1. Clarity Pharma, Trinity Life Sciences, MedaCorp, and ZS Associates. 2. MedaCorp market research. Diagnosed US Prevalence (Estimated)1 Number of FDA Approved Therapies % Physicians Who
Slide 5: QTORIN Rapamycin: Fourth Indication Announcement in 2H 2026
Microcystic LMs Cutaneous VMs Clinically Significant Angiokeratomas Additional Potential Future Indications2 TODAY FUTURE = 5k 30k+ 75k+ 200k+ 50k+1 QTORIN™ Rapamycin: Fourth Indication Announcement in 2H 2026 1. Clarity Pharma research (July 2025), n=643 physicians surveyed. 2. Lapa et al., Journal
Slide 6: QTORIN Rapamycin for Microcystic LMs: Pre-Launch Initiatives
QTORIN™ Rapamycin for Microcystic LMs: 1 1 2 2 2 3 2 4 2 5 RECRUIT AND DEPLOY Veteran Leadership Team POSITION AS Potential First Approved Therapy FIRST-LINE & STANDARD OF CARE ACTIVELY ENGAGE Physicians INCLUDING AT VASCULAR ANOMALY CENTERS BUILDING Patient Services Team FOR PATIENT ACCESS AND COVE
Slide 7: Leadership Executing on Key Pre-Launch Initiatives
Leadership Executing on Key Pre-Launch Initiatives Ashley Kline Chief Commercial Officer Led Oxervate® to >$500M; commercial leadership roles at Dompé and Genentech Jen McDonough SVP Market Access Led VYJUVEK® market access; former SVP, Patient Access, Analytics & Operations at Krystal Biotech Vimal
Slide 8: Opportunity to be First Approved Therapy in Microcystic LMs
QTORIN™ Rapamycin: Opportunity to be First Approved Therapy, First-Line and Standard of Care in Microcystic LMs Targets underlying mTOR pathobiology QTORIN™ 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.
Slide 9: Additional Pre-Launch Initiatives
Engaged over 200 of our initial 400 target clinics Meaningful presence at major medical congresses Additional Pre-Launch Initiatives Accelerating Physician Engagement INCLUDING VASCULAR ANOMALY CENTERS Hired field-based patient access liaison team leader, with team expansion ongoing Recent third-par
Slide 10: Regulatory Status: NDA Submission On Track for 2H 2026
Phase 3 SELVA and Phase 2 studies highly statistically significant and clinically meaningful; real-world studies as supportive evidence 2 Previously granted Breakthrough, Fast Track, and Orphan Designations, and FDA Orphan Drug Grant 505(b)(2) submission: leveraging FDA’s prior findings for rapamyci
Slide 11: Rare Disease Pipeline Updates
Rare Disease Pipeline Updates
Slide 12: Strong Medical Affairs Presence at Key Medical Congresses
Strong Medical Affairs Presence with Sponsorship and Presentations at Key Medical Congresses Platinum Sponsor at ISSVA World Congress (May 19-22, 2026) Title: QTORIN™ 3.9% Rapamycin Anhydrous Gel: Statistically Significant, Clinically Meaningful Improvement in Microcystic Lymphatic Malformations (Ph
Slide 13: New SELVA Data Highlight Benefits of Early Intervention in Children
All pre-specified age cohorts in ITT were highly statistically significant New SELVA Data Highlight Benefits of Early Intervention and Chronic Disease Management in Children Aged 6–11 Pre-Treatment On Treatment Day 1 Day 168 mLM-IGA: +3 “Very Much Improved” Age 7, Female Mean: +2.46 (p<0.001) Very M
Slide 14: Blinded Independent Review Confirmed Disease Stability and Improvement
Run-in Evaluation Period 8 Weeks Prespecified Blinded Independent Review Confirmed Disease Stability During Run-In and Marked Improvement with Treatment Note: To preserve blinding, different raters were used to compare Day -56 vs Day 1 and Day 1 vs Day 168 photographs. 1. Kato M et al., Plast Recons
Slide 15: Cutaneous Venous Malformations: Near-term Phase 3 Study Planned
Cutaneous Venous Malformations: Near-term Phase 3 Pivotal Study Planned No FDA-approved therapies Fast Track Designation Granted Pipeline-in-a-product: sNDA planned > 75k patients ESTIMATED DIAGNOSED IN THE U.S. POSITIVE PHASE 2 DATA ANNOUNCED DEC 2025 Most common vascular malformation Significant t
Slide 16: New TOIVA Data: Height/Engorgement and Appearance Improvements
Day 28 Day 56 Day 84 Day 168 (n=14) p-value 0.001 0.001 <0.001 <0.001 New TOIVA Data: Height/Engorgement and Appearance Improvements Continued Through 24 Weeks Demonstrating Deepening of Treatment Effect Over Time Day 28 Day 56 Day 84 Day 168 (n=14) p-value 0.027 0.001 <0.001 <0.001 Note: Mean chang
Slide 17: Clinically Significant Angiokeratomas: Superficial Lymphatic Malformations
> 50k patients ESTIMATED DIAGNOSED IN THE U.S. Clinically Significant Angiokeratomas: Superficial Lymphatic Malformations FIRST PATIENTS DOSED IN PHASE 2 TRIAL MAY 2026 A type of isolated lymphatic malformation: direct scientific adjacency to microcystic LMs FDA granted Fast Track Designation in Dec
Slide 18: New Articles Emphasize the Unmet Need of Angiokeratomas
New Articles Emphasize the Unmet Need of Clinically Significant Angiokeratomas Fordyce Angiokeratoma: An Unusual Localised Form in Childhood M. F. Reis, J. Lage, C. Ferreira, B. Henriques, and C. Amaro Journal of Paediatrics and Child Health 62, no. 2 (2026): 298–300, https://doi.org/10.1111/jpc.702
Slide 19: Disseminated Superficial Actinic Porokeratosis (DSAP)
> 50k patients ESTIMATED DIAGNOSED IN THE U.S. Disseminated Superficial Actinic Porokeratosis (DSAP): Chronic, Pre-Cancerous, and Progressive No FDA-approved therapies Current options: Laser, surgery, and off-label topical chemo agents & mevalonate pathway inhibitors QTORIN™ PITAVASTATIN POTENTIAL T
Slide 20: Finance & Cash Update
Finance & Cash Update palvella THERAPEUTICS
Slide 21: U.S. Launch and Rare Disease Pipeline Well-Funded with $251mm
Key strategic priorities accelerating: NDA initiated in 1H 2026 with rolling review Commercial and medical affairs expansion Major QTORIN™ pipeline and platform value drivers $251 million 6/30/26 cash Anticipated full-year 2026 cash expenses of $85 to $95 million U.S. Launch and Rare Disease Pipelin
Slide 22: Closing Remarks
Closing Remarks palvella THERAPEUTICS
Slide 23: What Makes Palvella Stand Apart
What Makes Palvella Stand Apart Repeatably unlocking multi-billion dollar market opportunities in previously untreated orphan diseases First-in-Disease Focus Rare Diseases with Clear Disease Biology Leveraging Existing Human Proof-of-Concept and Safety Data Innovative QTORIN™ Platform: Durable IP Ge
Slide 24: Q&A
; Q&A THERAPEUTICS
Slide 25: Thank You
Striving to be first for rare disease patients Thank You
Palvella Therapeutics — Q2 2026 Earnings Presentation on 6ix