Monitor for Cohort 2 enrollment updates and any interim safety/efficacy data releases. The next catalyst would be topline results from the Phase 1/2 study, which are not yet guided.
Price Chart
Executive Summary
Azitra announced that its Phase 1/2 trial of ATR-04 for EGFR inhibitor-associated skin rash has cleared the safety review committee and advanced to Cohort 2. Seven patients in Cohort 1 received treatment with no safety issues reported; Cohort 2 is expected to enroll approximately 24 patients. This is an early-stage clinical milestone for a pre-revenue biotech, with no financial data or efficacy results disclosed.
Key Facts
- Safety review committee cleared ATR-04 Phase 1/2 trial to proceed to Cohort 2 after reviewing data from 6 patients in Cohort 1.
- Cohort 1 enrolled 7 patients who received a single 4g application followed by once-daily dosing for 28 days.
- Cohort 2 expected to enroll approximately 24 patients with once-daily 4g application for 28 days.
- Trial is being conducted at 6 sites including MD Anderson Cancer Center and Yale University.
- ATR-04 has FDA Fast Track designation for EGFRi-associated rash, which affects approximately 150,000 patients annually in the U.S.
Financial Impact
No financial data reported; clinical-stage company with no revenue from ATR-04.
Risk Factors
- Early-stage clinical results may not be predictive of later-stage outcomes.
- Enrollment delays or safety issues in Cohort 2 could slow the program.
- Company may require additional funding to complete the trial.
Investment Themes
Documents Analyzed
This report is based on 5 SEC documents filed with EDGAR.
| Document | Accession Number |
|---|---|
| 8-K Filing (Primary) | 0001493152-26-045260 |
| Exhibit: ex99-1.htm | 0001493152-26-045260 |
| Document: 0001493152-26-045260-index-headers.html | 0001493152-26-045260 |
| Document: 0001493152-26-045260-index.html | 0001493152-26-045260 |
| Document: 0001493152-26-045260.txt | 0001493152-26-045260 |
Filters
| Type | Now | ||||
|---|---|---|---|---|---|
Oct 26, 2026 today | 8-K | — | awaiting T+1 | — | — |
Oct 22, 2026 3d ago | 8-K | $0.0720 | awaiting T+1 | — | — |
Oct 1, 2026 25d ago | 8-K | $0.1285 $0.1320 | ▲ +2.72% | ▲ +1.98% | — |
Aug 21, 2026 9w ago | 8-K | $0.1328 $0.1504 | ▲ +13.25% | ▲ +13.55% | — |
Aug 12, 2026 10w ago | Press Release | $0.1400 $0.1393 | ▲ +0.50% | ▲ +0.30% | — |
Jun 17, 2026 18w ago | 8-K | $0.2030 $0.1717 | ▼ −15.42% | ▼ −16.20% | — |
Jun 3, 2026 20w ago | EFFECT | $0.2240 $0.2180 | ▲ +2.68% | ▲ +3.08% | — |
May 21, 2026 22w ago | S-1 | $0.2040 $0.2100 | ▼ −2.94% | ▼ −2.36% | — |
Mar 5, 2026 33w ago | 8-K | $0.1800 $0.2030 | ▲ +12.78% | ▲ +11.93% | — |
US Market Status
Subscribe to SecBot
Get Real-Time SEC Filing Intelligence
Comprehensive SEC filing analysis delivered the moment filings hit EDGAR. Sentiment scoring, impact analysis, and actionable insights for every material event.
Create a free account Live analysis, Telegram alerts, watchlists and the MCP server for subscribers