The rolling NDA submission for ALXN1840 is the primary value driver — completion and FDA acceptance within months could trigger significant upside. The RPD designation adds PRV optionality worth $100M+. Cash runway through 2027 eliminates near-term dilution risk. Monitor for NDA completion announcement and any FDA filing acceptance.
Price Chart
Executive Summary
Monopar Therapeutics reported Q2 2026 net loss of $5.3M ($0.62/share), wider than the $2.5M loss in Q2 2025, driven by increased R&D spending on ALXN1840 NDA preparation and commercial readiness. The key catalyst is the ongoing rolling NDA submission for ALXN1840 in Wilson disease, with Rare Pediatric Disease designation providing potential for a Priority Review Voucher. Cash of $134.3M funds operations through at least December 2027, removing near-term financing risk for this pre-revenue biotech.
Key Financial Metrics
Key Facts
- Net loss Q2 2026: $5.3M ($0.62/share) vs $2.5M ($0.35/share) in Q2 2025
- Cash, cash equivalents and investments: $134.3M as of June 30, 2026
- Cash runway through at least December 31, 2027
- Rolling NDA submission for ALXN1840 initiated July 22, 2026; completion expected within months
- FDA granted Rare Pediatric Disease (RPD) designation for ALXN1840 on June 30, 2026
- R&D expenses increased to $4.77M from $1.73M YoY, driven by NDA preparation and clinical activities
- Interest income $1.30M vs $0.78M YoY from ~$91.9M September 2025 capital raise proceeds
Financial Impact
Net loss widened $2.8M YoY to $5.3M; cash burn rate increased with R&D spending up $3.0M
Risk Factors
- FDA may not accept the NDA for filing or may issue a Complete Response Letter
- Commercial launch execution risk for a rare disease drug with no prior Monopar commercial infrastructure
- No revenue until potential ALXN1840 approval; continued operating losses
- Competition from existing Wilson disease therapies (trientine, zinc, penicillamine)
Market Snapshot
Investment Themes
Documents Analyzed
This report is based on 6 SEC documents filed with EDGAR.
| Document | Accession Number |
|---|---|
| 8-K Filing (Primary) | 0001437749-26-027165 |
| Exhibit: ex_1003235.htm | 0001437749-26-027165 |
| Document: 0001437749-26-027165-index-headers.html | 0001437749-26-027165 |
| Document: 0001437749-26-027165-index.html | 0001437749-26-027165 |
| Document: 0001437749-26-027165.txt | 0001437749-26-027165 |
| 8-K Data (Synthetic) | 0001437749-26-027165 |
Filters
| Type | Now | ||||
|---|---|---|---|---|---|
Oct 5, 2026 21d ago | Insider Cluster | $79.57 | awaiting T+60 | — | $70.54 (+11.35%) |
Oct 1, 2026 25d ago | 144 | $77.97 | awaiting T+60 | — | $70.54 (−9.53%) |
Aug 28, 2026 8w ago | Insider Cluster | $111.93 | awaiting T+60 | — | $70.54 (−36.98%) |
Aug 27, 2026 8w ago | Insider Cluster | $111.89 | awaiting T+60 | — | $70.54 (−36.96%) |
Aug 25, 2026 8w ago | 144 | $113.72 | awaiting T+60 | — | $70.54 (−37.97%) |
Aug 12, 2026 10w ago | 8-K | $114.90 | awaiting T+60 | — | $70.54 (−38.61%) |
Aug 12, 2026 10w ago | Press Release | $114.90 | awaiting T+60 | — | $70.54 (−38.61%) |
Jul 22, 2026 13w ago | 8-K | $112.48 $71.80 | ▼ −36.17% | ▼ −39.43% | $70.54 (−37.29%) |
Jul 22, 2026 13w ago | Press Release | $112.48 $71.80 | ▼ −36.17% | ▼ −39.43% | $70.54 (−37.29%) |
Jun 30, 2026 16w ago | 8-K | $92.59 $89.38 | ▼ −3.47% | ▼ −7.03% | $70.54 (−23.81%) |
US Market Status
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