Palvella Therapeutics (PVLA) investor relations material

Executive summary

• Achieved key milestones: positive Phase 3 SELVA results for QTORIN rapamycin in microcystic lymphatic malformations (mLM), rolling NDA submission with first module submitted, and commercial leadership team assembled for launch readiness.

• Expanded QTORIN platform pipeline includes cutaneous venous malformations (cVM), angiokeratomas, DSAP, and additional indications, all targeting rare diseases with no FDA-approved therapies.

• NDA submission for QTORIN rapamycin in mLM on track for completion in H2 2026, with potential FDA approval in H1 2027 and commercial launch preparations underway.

• Strong physician and payer interest in first-in-disease therapies, with multibillion-dollar addressable markets supported by epidemiology data.

• Significant events include uplisting to Nasdaq, board appointments, and industry recognition for innovation.

Financial highlights

• Ended Q2 2026 with $250.6–$251 million in cash, following a $230 million capital raise in Q1/Q2 2026.

• Operating expenses for Q2 2026 were $21.4 million, up from $9.3 million in Q2 2025, driven by increased R&D and G&A costs.

• Net loss was $21.9 million ($1.52 per share) in Q2 2026, with a six-month net loss of $37.6 million.

• Cash position supports full pipeline advancement and commercial launch readiness.

• February 2026 equity offering raised $215.8 million net proceeds; PIPE financing and convertible notes converted at merger.

Outlook and guidance

• NDA submission for QTORIN rapamycin in mLM expected to complete in H2 2026; potential FDA approval and commercial launch in H1 2027.

• Phase 3 trial for cVM to begin in Q4 2026; Phase 2 trial for DSAP to start in H2 2026; topline Phase 2 LOTU results for angiokeratomas expected H2 2027.

• Plans to announce additional QTORIN platform indications and candidates in H2 2026.