Avalyn Pharma (AVLN) investor relations material

Executive summary

• Clinical-stage pipeline includes AP01 inhaled pirfenidone for PPF, AP02 inhaled nintedanib for IPF, and AP03 inhaled combination therapy; no product revenue to date.

• AP03 Phase 1 began, while AP01 and AP02 trials advanced; key clinical data are anticipated in 2027.

• Cash, cash equivalents and marketable securities totaled $386.6M at September 30, 2026, supporting a projected runway into 2029.

Financial highlights

• Q3 operating expenses rose 31% to $33.1M; net loss widened to $29.7M from $23.6M, partly offset by $3.4M of other income.

• Q3 R&D was $25.5M vs. $22.1M and G&A was $7.6M vs. $3.2M; increases reflected program activity, headcount and personnel costs, including stock-based compensation.

• 9M operating expenses rose to $92.3M from $65.8M; net loss grew to $85.5M from $61.3M, while other income increased to $6.8M from $4.5M.

• 9M R&D was $73.1M vs. $55.3M and G&A was $19.2M vs. $10.5M; post-IPO stock-based compensation contributed to expense growth.

• Basic and diluted loss per share was $0.67 in Q3 2026 vs. $20.34 in Q3 2025, and $3.39 for 9M vs. $69.29, reflecting a larger weighted-average share count after the IPO.

Outlook and guidance

• AP01 MIST Phase 2b topline data in PPF are anticipated in H2 2027; the trial overenrolled with 398 randomized patients.

• AP02 AURA Phase 2 topline data in IPF are anticipated in late 2027; the trial is enrolling and designed for 160 patients.

• AP03 Phase 1 healthy-volunteer results are anticipated in H2 2027; the study is expected to enroll at least 32 participants.

• Cash, cash equivalents and marketable securities are expected to fund operating expenses and capital expenditures into 2029, subject to assumptions that may change.

• Expenses and operating losses are expected to rise substantially as clinical programs, manufacturing, pipeline work and public-company costs expand.