Palvella Therapeutics (PVLA) Registration Filing summary

Company overview and business model

• Clinical-stage biopharmaceutical company focused on developing and commercializing therapies for serious, rare skin diseases with no FDA-approved treatments.

• Utilizes the QTORIN platform to create therapies that penetrate deep skin layers for local treatment of rare skin diseases.

• Lead candidate QTORIN 3.9% rapamycin gel is in clinical development for microcystic lymphatic malformations and cutaneous venous malformations.

• Ongoing Phase 3 (SELVA) and Phase 2 (TOIVA) trials, with additional pipeline expansion into angiokeratomas and DSAP.

• Recent positive topline results from Phase 2 TOIVA study for cutaneous VMs, showing significant improvements in both clinician- and patient-reported outcomes.

Financial performance and metrics

• Common stock listed on Nasdaq Capital Market under the symbol “PVLA”; last reported sale price on December 31, 2025, was $104.67 per share.

• Registration statement allows for up to $300,000,000 in aggregate securities offerings.

Use of proceeds and capital allocation

• Net proceeds from securities sales will be used as set forth in the applicable prospectus supplement.