The MIST Phase 2b enrollment completion is a positive derisking event, but topline data is 12+ months away. Monitor for ERS Congress abstracts in September 2026 and any early safety/efficacy signals. The strong cash runway reduces near-term dilution risk, but the stock remains binary on AP01 data in H2 2027.
Price Chart
Executive Summary
Avalyn Pharma reported a Q2 2026 net loss of $28.9M ($-0.56 EPS, in line with consensus) on zero revenue, with R&D expenses rising to $24.7M as the company advances its inhaled pulmonary fibrosis pipeline. The key catalyst is the completion of enrollment (398 patients, overenrolled) in the MIST Phase 2b trial for AP01, with topline data expected in H2 2027, and a strong cash position of $413.5M providing runway into 2029.
Key Financial Metrics
Key Facts
- Completed enrollment of MIST Phase 2b trial for AP01 with 398 patients (overenrolled from 375 target); topline data expected H2 2027.
- Cash, cash equivalents, and marketable securities of $413.5M as of June 30, 2026, including ~$316.6M net IPO proceeds; cash runway projected into 2029.
- Net loss of $28.9M for Q2 2026 vs $20.2M in Q2 2025; R&D expenses $24.7M vs $17.9M; G&A expenses $6.6M vs $3.9M.
- AP02 (inhaled nintedanib) AURA Phase 2 trial enrollment on track (target 160 patients); topline data expected late 2027.
- AP03 (inhaled fixed-dose combination of pirfenidone and nintedanib) Phase 1 study on track to initiate by end of 2026.
- Two abstracts accepted for ERS Congress September 2026, including lung tissue distribution modeling for AP01.
Financial Impact
Net loss of $28.9M in Q2 2026, with $413.5M cash runway into 2029; no revenue reported.
Risk Factors
- Topline data from MIST Phase 2b not expected until H2 2027, creating a long wait for a binary catalyst.
- Clinical-stage biotech with no approved products or revenue; net loss widening year-over-year.
Market Snapshot
Documents Analyzed
This report is based on 1 press release from GlobeNewswire.
| Document | Accession Number |
|---|---|
| PRESS-RELEASE Data (Synthetic) | press-3343572 |
Filters
| Type | Now | ||||
|---|---|---|---|---|---|
Sep 21, 2026 5w ago | Press Release | $31.62 $28.32 | ▼ −10.44% | ▼ −9.42% | $26.04 (−17.65%) |
Aug 16, 2026 10w ago | Institutional Cluster | $38.25 $37.69 | ▼ −1.46% | ▼ −0.27% | $26.04 (−31.92%) |
Aug 12, 2026 10w ago | 8-K | $37.38 $38.97 | ▲ +4.25% | ▲ +4.70% | $26.04 (−30.34%) |
Aug 12, 2026 10w ago | Press Release | $37.38 $38.97 | ▲ +4.25% | ▲ +4.70% | $26.04 (−30.34%) |
Jun 17, 2026 18w ago | 8-K | $29.31 $30.09 | ▲ +2.66% | ▲ +3.70% | $26.04 (−11.16%) |
Jun 17, 2026 18w ago | Press Release | $29.31 $30.09 | ▲ +2.66% | ▲ +3.70% | $26.04 (−11.16%) |
Jun 3, 2026 20w ago | 8-K | $26.40 $28.53 | ▲ +8.07% | ▲ +11.89% | $26.04 (−1.36%) |
May 5, 2026 24w ago | Press Release | $27.71 $29.90 | ▲ +7.90% | ▲ +6.77% | $26.04 (−6.03%) |
May 1, 2026 25w ago | Insider Cluster | $29.07 $29.57 | ▲ +1.72% | ▼ −1.25% | $26.04 (−10.42%) |
May 1, 2026 25w ago | Insider Cluster | $29.07 $29.57 | ▲ +1.72% | ▼ −1.25% | $26.04 (−10.42%) |
US Market Status
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