AVLN Avalyn Pharma Inc.
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Executive Summary
Avalyn Pharma reported Q1 2026 results showing a net loss of $26.9M, wider than the $17.5M loss in Q1 2025, driven by increased R&D spend on its Phase 2b MIST trial and Phase 2 AURA trial. The company highlighted its upsized IPO raising $345M in gross proceeds, extending its cash runway into 2029, and reiterated pipeline milestones including MIST enrollment completion mid-2026 and topline data in H2 2027. As a pre-revenue clinical-stage biotech, the filing contains no revenue or EPS surprises to trade on — the stock will move on pipeline catalysts and cash runway updates, not quarterly financials.
Actionable Insight
Monitor MIST Phase 2b enrollment completion (mid-2026) and topline data (H2 2027) as the primary catalysts. The IPO removes near-term financing risk, shifting focus to clinical execution. Watch for any enrollment delays or safety signals in upcoming data presentations at EULAR (June 6, 2026).
Key Facts
- Net loss of $26.9M for Q1 2026 vs $17.5M in Q1 2025
- Cash, cash equivalents, and marketable securities of $123.1M as of March 31, 2026, excluding IPO proceeds
- Upsized IPO in May 2026 raised gross proceeds of $345.0M (19,166,667 shares at $18.00)
- Net IPO proceeds of ~$316.1M extend cash runway into 2029
- R&D expenses increased to $22.9M from $15.3M YoY, driven by AP01 Phase 2b and AP02 Phase 2 trials
- MIST Phase 2b trial of AP01 in PPF on track to complete enrollment mid-2026, topline data expected H2 2027
- AURA Phase 2 trial of AP02 in IPF enrollment underway, topline data expected late 2027
- Phase 1 trial of AP03 (fixed-dose combination) on track to initiate by end of 2026
- No revenue reported — pre-revenue clinical-stage company
Financial Impact
Net loss widened by $9.4M YoY to $26.9M; cash burn rate ~$9.0M/month in Q1 2026; post-IPO cash runway extended into 2029
Risk Factors
- Clinical trial enrollment delays or unexpected safety/efficacy data
- Dilution from future equity financings if cash runway shortens
- Competitive landscape changes in pulmonary fibrosis treatments
- Regulatory setbacks in Phase 2b or Phase 2 trials
Market Snapshot
Documents Analyzed
This report is based on 6 SEC documents filed with EDGAR.
| Document | Accession Number |
|---|---|
| 8-K Filing (Primary) | 0001193125-26-254581 |
| Document: ck0001540171-20260603.htm | 0001193125-26-254581 |
| Document: 0001193125-26-254581-index-headers.html | 0001193125-26-254581 |
| Document: 0001193125-26-254581-index.html | 0001193125-26-254581 |
| Document: 0001193125-26-254581.txt | 0001193125-26-254581 |
| 8-K Data (Synthetic) | 0001193125-26-254581 |
Track record builds as more directional reports settle.
Filters
| Type | Now | ||||
|---|---|---|---|---|---|
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Jun 3, 2026
9d ago
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8-K
| $26.40 $26.99 | ▲ +2.23% | ▲ +1.84% | $30.08 (+13.94%) |
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May 5, 2026
5w ago
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Press Release
| $27.71 $27.71 | · 0.00% | ▲ +0.33% | $30.08 (+8.55%) |
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May 1, 2026
6w ago
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Insider Cluster
| $29.84 $29.07 | ▼ −2.58% | ▼ −2.24% | $30.08 (+0.80%) |
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May 1, 2026
6w ago
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Insider Cluster
| $29.84 $29.07 | ▼ −2.58% | ▼ −2.24% | $30.08 (+0.80%) |
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Apr 30, 2026
6w ago
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424B4
| $29.84 $29.07 | ▼ −2.58% | ▼ −2.24% | $30.08 (+0.80%) |
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Apr 30, 2026
6w ago
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Press Release
| $29.49 $29.84 | ▲ +1.19% | ▲ +0.97% | $30.08 (+2.00%) |
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Apr 30, 2026
6w ago
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3
| $29.49 $29.84 | ▲ +1.19% | ▲ +0.97% | $30.08 (+2.00%) |
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Apr 30, 2026
6w ago
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3
| $29.49 $29.84 | ▲ +1.19% | ▲ +0.97% | $30.08 (+2.00%) |
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Apr 29, 2026
6w ago
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3
| $29.49 $29.84 | ▲ +1.19% | ▲ +0.97% | $30.08 (+2.00%) |
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Apr 29, 2026
6w ago
|
S-1/A
| — | awaiting T+1 | — | — |
US Market Status
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