Monitor the progress of the MIST (AP01) and AURA (AP02) clinical trials, with topline data expected in the second half of 2027 and late 2027, respectively, as these will be critical catalysts for the company's valuation.
Executive Summary
Avalyn Pharma is a clinical-stage biopharmaceutical company developing inhaled formulations of approved oral antifibrotic drugs (pirfenidone and nintedanib) to treat progressive pulmonary fibrosis (PPF) and idiopathic pulmonary fibrosis (IPF). The company is conducting a $201.5 million IPO to fund late-stage clinical trials for its lead candidates, AP01 and AP02, and early development of a fixed-dose combination therapy, AP03. The offering is priced at $17.00 per share, with proceeds intended to advance the pipeline into Phase 3 trials.
Key Financial Metrics
Key Facts
- Company is a clinical-stage biopharma focused on inhaled therapies for rare respiratory diseases, specifically pulmonary fibrosis.
- Lead candidates are AP01 (inhaled pirfenidone) in a Phase 2b trial for PPF and AP02 (inhaled nintedanib) in a Phase 2 trial for IPF.
- IPO of 11.8 million shares at $16-$18 per share, raising $181.8 million net, to fund development of AP01, AP02, and AP03.
- Company has incurred significant losses, with net losses of $85.2 million in 2025 and $49.7 million in 2024, and an accumulated deficit of $265.4 million.
- The company is dependent on the success of its lead candidates and will need substantial additional funding beyond this offering.
Financial Impact
The company will raise $181.8 million in net proceeds from the IPO, which, combined with existing cash, is expected to fund operations into 2029.
Risk Factors
- The company has a history of significant operating losses and may never achieve profitability.
- It is substantially dependent on the success of its lead candidates, AP01 and AP02, which are still in clinical development.
- The company will need substantial additional funding after this offering, and there is no guarantee it can raise capital on acceptable terms.
Documents Analyzed
This report is based on 3 SEC documents filed with EDGAR.
| Document | Accession Number |
|---|---|
| S-1/A Filing (Primary) | 0001193125-26-173632 |
| Document: ck0001540171-ex10_3.htm | 0001193125-26-173632 |
| Document: ck0001540171-ex1_1.htm | 0001193125-26-173632 |
Filters
| Type | Now | ||||
|---|---|---|---|---|---|
Sep 21, 2026 5w ago | Press Release | $31.62 $28.32 | ▼ −10.44% | ▼ −9.42% | $27.14 (−14.17%) |
Aug 16, 2026 10w ago | Institutional Cluster | $38.25 $37.69 | ▼ −1.46% | ▼ −0.27% | $27.14 (−29.05%) |
Aug 12, 2026 10w ago | 8-K | $37.38 $38.97 | ▲ +4.25% | ▲ +4.70% | $27.14 (−27.39%) |
Aug 12, 2026 10w ago | Press Release | $37.38 $38.97 | ▲ +4.25% | ▲ +4.70% | $27.14 (−27.39%) |
Jun 17, 2026 18w ago | 8-K | $29.31 $30.09 | ▲ +2.66% | ▲ +3.70% | $27.14 (−7.40%) |
Jun 17, 2026 18w ago | Press Release | $29.31 $30.09 | ▲ +2.66% | ▲ +3.70% | $27.14 (−7.40%) |
Jun 3, 2026 20w ago | 8-K | $26.40 $28.53 | ▲ +8.07% | ▲ +11.89% | $27.14 (+2.80%) |
May 5, 2026 24w ago | Press Release | $27.71 $29.90 | ▲ +7.90% | ▲ +6.77% | $27.14 (−2.06%) |
May 1, 2026 25w ago | Insider Cluster | $29.07 $29.57 | ▲ +1.72% | ▼ −1.25% | $27.14 (−6.64%) |
May 1, 2026 25w ago | Insider Cluster | $29.07 $29.57 | ▲ +1.72% | ▼ −1.25% | $27.14 (−6.64%) |
US Market Status
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