Monitor the IPO pricing and first-day trading performance for AVLN. Key catalysts to watch are Phase 2b data for AP01 (MIST trial) expected in H2 2027 and Phase 2 data for AP02 (AURA trial) expected in late 2027. The company's cash runway into 2029 reduces near-term financing risk.
Executive Summary
Avalyn Pharma filed Amendment No. 2 to its S-1 registration statement for an IPO of 16,666,667 shares of common stock, with an estimated price range of $16.00 to $18.00 per share. The company is a clinical-stage biopharmaceutical company developing inhaled therapies for pulmonary fibrosis, with net losses of $85.2 million in 2025 and an accumulated deficit of $265.4 million. The offering is expected to generate net proceeds of approximately $258.7 million to fund clinical development of its lead candidates AP01 and AP02 through 2029.
Key Financial Metrics
Key Facts
- Offering 16,666,667 shares of common stock at an estimated price range of $16.00 to $18.00 per share.
- Underwriters have a 30-day option to purchase up to an additional 2,500,000 shares.
- Net proceeds estimated at $258.7 million (or $298.2 million if underwriters exercise option in full), based on the $17.00 midpoint.
- Net losses were $85.2 million for 2025 and $49.7 million for 2024; accumulated deficit of $265.4 million as of December 31, 2025.
- Cash, cash equivalents, and marketable securities were $138.4 million as of December 31, 2025.
- Proceeds intended to fund development of AP01, AP02, and AP03, with cash runway into 2029.
- Company has an exclusive license to PARI's eRapid Nebulizer System for its product candidates.
- Lead candidates: AP01 (inhaled pirfenidone) in Phase 2b for PPF; AP02 (inhaled nintedanib) in Phase 2 for IPF.
Financial Impact
IPO expected to raise ~$258.7M in net proceeds; company has $138.4M in cash and $15.0M drawn on a $30.0M term loan facility.
Risk Factors
- Clinical-stage company with no approved products or revenue; history of significant operating losses.
- Dependence on successful clinical development and regulatory approval of AP01 and AP02.
- Novel inhaled formulation approach for pulmonary fibrosis carries development and regulatory uncertainty.
- Reliance on third-party manufacturers and the PARI device license for product delivery.
- Substantial additional funding will be needed beyond the IPO to complete development and commercialization.
Documents Analyzed
This report is based on 8 SEC documents filed with EDGAR.
| Document | Accession Number |
|---|---|
| S-1/A Filing (Primary) | 0001193125-26-189477 |
| Document: ck0001540171-ex10_9.htm | 0001193125-26-189477 |
| Document: ck0001540171-exfiling_fees.htm | 0001193125-26-189477 |
| Document: ck0001540171-ex5_1.htm | 0001193125-26-189477 |
| Document: ck0001540171-ex23_1.htm | 0001193125-26-189477 |
| Document: 0001193125-26-189477-index-headers.html | 0001193125-26-189477 |
| Document: 0001193125-26-189477-index.html | 0001193125-26-189477 |
| Document: 0001193125-26-189477.txt | 0001193125-26-189477 |
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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