No near-term financial catalysts; the next major event is MIST topline data in H2 2027. Monitor for AP03 Phase 1 initiation by year-end 2026 and any early data from AURA. Cash runway into 2029 reduces dilution risk but provides no immediate trading catalyst.
Price Chart
Executive Summary
Avalyn Pharma reported Q2 2026 results with no revenue and a net loss of $28.9M, widening from $20.2M a year ago due to increased R&D spending on its pulmonary fibrosis pipeline. The key operational milestone was completing enrollment of the MIST Phase 2b trial (398 patients, overenrolled), with topline data expected in H2 2027. Cash position of $413.5M (including IPO proceeds) funds operations into 2029, but no near-term financial catalysts exist.
Key Facts
- Completed enrollment of MIST Phase 2b trial of AP01 in PPF with 398 patients (target 375); topline data H2 2027
- Net loss of $28.9M in Q2 2026 vs $20.2M in Q2 2025, driven by higher R&D ($24.7M vs $17.9M) and G&A ($6.6M vs $3.9M) expenses
- Cash, cash equivalents, and marketable securities of $413.5M as of June 30, 2026, including $316.6M net IPO proceeds; runway into 2029
- AP02 AURA Phase 2 trial enrollment on track; topline data expected late 2027
- AP03 Phase 1 study on track to initiate by end of 2026
Financial Impact
No revenue; net loss increased by $8.7M YoY; cash position strengthened by IPO proceeds
Risk Factors
- Clinical trial failure risk for AP01, AP02, or AP03
- Potential dilution if additional financing needed before data readouts
- No revenue or near-term path to profitability
Market Snapshot
Documents Analyzed
This report is based on 6 SEC documents filed with EDGAR.
| Document | Accession Number |
|---|---|
| 8-K Filing (Primary) | 0001193125-26-345807 |
| Document: ck0001540171-20260812.htm | 0001193125-26-345807 |
| Document: 0001193125-26-345807-index-headers.html | 0001193125-26-345807 |
| Document: 0001193125-26-345807-index.html | 0001193125-26-345807 |
| Document: 0001193125-26-345807.txt | 0001193125-26-345807 |
| 8-K Data (Synthetic) | 0001193125-26-345807 |
Filters
| Type | Now | ||||
|---|---|---|---|---|---|
Sep 21, 2026 5w ago | Press Release | $31.62 $28.32 | ▼ −10.44% | ▼ −9.42% | $25.83 (−18.31%) |
Aug 16, 2026 10w ago | Institutional Cluster | $38.25 $37.69 | ▼ −1.46% | ▼ −0.27% | $25.83 (−32.47%) |
Aug 12, 2026 10w ago | 8-K | $37.38 $38.97 | ▲ +4.25% | ▲ +4.70% | $25.83 (−30.90%) |
Aug 12, 2026 10w ago | Press Release | $37.38 $38.97 | ▲ +4.25% | ▲ +4.70% | $25.83 (−30.90%) |
Jun 17, 2026 18w ago | 8-K | $29.31 $30.09 | ▲ +2.66% | ▲ +3.70% | $25.83 (−11.87%) |
Jun 17, 2026 18w ago | Press Release | $29.31 $30.09 | ▲ +2.66% | ▲ +3.70% | $25.83 (−11.87%) |
Jun 3, 2026 20w ago | 8-K | $26.40 $28.53 | ▲ +8.07% | ▲ +11.89% | $25.83 (−2.16%) |
May 5, 2026 25w ago | Press Release | $27.71 $29.90 | ▲ +7.90% | ▲ +6.77% | $25.83 (−6.78%) |
May 1, 2026 25w ago | Insider Cluster | $29.07 $29.57 | ▲ +1.72% | ▼ −1.25% | $25.83 (−11.15%) |
May 1, 2026 25w ago | Insider Cluster | $29.07 $29.57 | ▲ +1.72% | ▼ −1.25% | $25.83 (−11.15%) |
US Market Status
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