AVLN•Avalyn Pharma reported R&D expenses of $22.9 million and held $123.1 million cash as of March 31, 2026, backed by a $345 million IPO to fund operations into 2029. Enrollment in the MIST Phase 2b trial for inhaled pirfenidone remains on track for mid-2026, while AP02 Phase 2 dosing began.
Avalyn Pharma reported R&D expenses of $22.9 million for Q1 2026, up from $15.3 million a year earlier, driven by progression of Phase 2 and open-label extension studies. Cash, cash equivalents, and marketable securities totaled $123.1 million as of March 31, 2026, excluding $316.1 million in net IPO proceeds, providing funding into 2029.
Enrollment in the MIST Phase 2b trial of inhaled pirfenidone (AP01) is on track for mid-2026 completion, with 375 patients evaluating change in FVC over 52 weeks and favorable long-term tolerability trends observed in extension data. AP02 Phase 2 randomized dosing began in March 2026, with topline data expected in late 2027, while AP03 Phase 1 initiation is slated for end-2026.
In May 2026, Avalyn completed an upsized IPO, selling 19.17 million shares at $18 each and generating gross proceeds of $345 million. The company strengthened its leadership by appointing a General Counsel and a Senior Vice President of Commercial to support the next growth phase.
Management will present at the Jefferies Global Healthcare Conference on June 4, 2026, and unveil PPF extension data at the EULAR conference on June 6. Topline data for AP01 and AP02 trials are anticipated in the second half of 2027, and the AP03 Phase 1 trial is expected to start by year-end.