Palvella Therapeutics (PVLA) investor relations material

Executive summary

• Achieved positive Phase 3 SELVA results for QTORIN rapamycin in microcystic lymphatic malformations (mLM), supporting NDA submission in the second half of 2026 and potential U.S. launch in 2027, with Breakthrough Therapy Designation and strong physician support.

• Accelerated clinical progress across pipeline: Phase 3 initiation for cutaneous venous malformations (cVMs), Phase 2 trials for angiokeratomas and DSAP, and expanded QTORIN platform candidates.

• Expanded leadership and board, completed upsized $230 million equity financing in February 2026 to support launch readiness and commercial buildout.

• Disease awareness campaigns and advocacy partnerships launched to support future product launches.

Financial highlights

• Ended Q1 2026 with $261.9 million in cash and cash equivalents, including short-term investments, following $230 million equity financing.

• Net loss for Q1 2026 was $15.8 million ($1.20 per share), up from $8.2 million ($0.74 per share) in Q1 2025, driven by increased R&D and G&A expenses.

• Operating expenses rose to $14.9 million for Q1 2026, with R&D at $9.3 million and G&A at $5.5 million.

• Cash runway expected to last through cash flow break-even, assuming first half 2027 approval and launch.

Outlook and guidance

• NDA submission for QTORIN rapamycin in mLM targeted for the second half of 2026, with potential FDA approval and U.S. launch in the first half of 2027.

• Phase 3 study for cVM to initiate in the second half of 2026; Phase 2 LOTU trial in angiokeratomas underway with data expected in the second half of 2027; DSAP Phase 2 initiation planned for the second half of 2026.

• Plans to expand the pipeline to six indications by year-end 2026, including new QTORIN product candidates.