Palvella Therapeutics, Inc.

R&D Investment Surge Nine months R&D spending reached $15.72M, up $10.11M, driven by SELVA Phase 3 and TOIVA Phase 2 clinical trials.

Key Clinical Milestones Met Completed enrollment for Phase 3 SELVA trial (51 subjects) and Phase 2 TOIVA trial (16 subjects) during the reporting period.

Cash Runway Extended Cash and equivalents totaled $63.57M as of September 30, 2025, funding operations into the second half of 2027.

New Pipeline Candidate Announced new QTORIN candidate, pitavastatin, for DSAP treatment; planning Phase 2 study initiation in the second half of 2026.

Net Loss Widened Substantially Net loss for nine months reached $(29.00M), significantly wider than the $(13.48M) loss reported in the prior year period.

Increased Operating Cash Burn Net cash used in operating activities increased to $(20.08M) for nine months, reflecting higher R&D and public company costs.

Operating Expenses Increased Total operating expenses surged $17.57M to $27.30M for nine months, driven by R&D scaling and G&A headcount additions.

Future Capital Dependency Continued operations beyond H2 2027 depend on raising additional capital, success of which cannot be assured by management.

Upcoming Data Readouts Expect to report top-line data for Phase 3 SELVA study in Q1 2026 and TOIVA study in mid-December 2025.

Regulatory Discussion Planned Plan to meet with the FDA in H1 2026 to discuss proposed design for Phase 2 study evaluating angiokeratomas treatment.

Anticipated R&D Cost Increase Expect substantial increase in R&D expenses continuing to advance late-stage clinical development and pursue regulatory approvals.

Public Company Costs Rising Anticipate substantial future increase in G&A expenses related to operating as a publicly-traded company structure.