Avalyn Pharma (AVLN) investor relations material

Executive summary

• Completed IPO in May 2026, raising $316.6 million in net proceeds, with all preferred stock converting to common stock.

• Lead candidates AP01 and AP02 are in Phase 2b and Phase 2 trials for rare respiratory diseases; AP03 combination therapy to enter Phase 1 by end of 2026.

• Completed global enrollment of the MIST Phase 2b trial for AP01 in progressive pulmonary fibrosis, enrolling 398 patients with topline data expected in H2 2027.

• Presented and accepted abstracts at the European Respiratory Society Congress, highlighting AP01 lung tissue distribution and patient-centric trial design.

• No revenue generated to date; focus remains on advancing clinical pipeline and expanding R&D.

Financial highlights

• Net loss of $28.9 million for Q2 2026, up from $20.2 million in Q2 2025; six-month net loss of $55.8 million, up from $37.7 million year-over-year.

• Operating expenses rose to $31.3 million for Q2 2026, driven by increased R&D and G&A costs.

• Cash, cash equivalents, and marketable securities totaled $413.5 million as of June 30, 2026.

• R&D expenses for Q2 2026: $24.7 million; G&A expenses: $6.6 million.

• Total assets at June 30, 2026 were $425.4 million; total liabilities were $27.1 million.

Outlook and guidance

• Current cash position expected to fund operations into 2029, based on current operating plans.

• Topline data for MIST (AP01) expected in H2 2027; AURA (AP02) topline data anticipated in late 2027.

• Phase 1 trial of AP03 expected to initiate by end of 2026.

• Expenses and operating losses projected to increase as clinical programs advance and company scales operations.

• Additional capital will be required for future development and commercialization efforts.