A Multicenter, Phase 2, Open-Label Study Evaluating The Safety And Efficacy of Sirolimus 3.9% Topical Gel (PTX-022) In The Treatment of Microcystic Lymphatic Malformations
Phase: PHASE2
Conditions: Microcystic Lymphatic Malformation
Sponsor: Palvella Therapeutics, Inc.

PTX-022 
Palvella Therapeutics, Inc. 
Protocol PALV-06
27June2022 
Amendment #4 
Confidential 
A MULTICENTER, PHASE 2, OPEN-LABEL STUDY EVALUATING THE SAFETY 
AND EFFICACY OF SIROLIMUS 3.9% TOPICAL GEL (PTX-022) IN THE 
TREATMENT OF MICROCYSTIC LYMPHATIC MALFORMATIONS  
Protocol Number: PALV-06 
Compound Number 
PTX-022 
Sponsor Name: 
Palvella Therapeutics, Inc. 
Legal Registered Address: 
125 Strafford Ave, Suite 360 
Wayne, PA 19087 
Regulatory Agency Identifying 
Number(s): 
Approval Date 
27June2022