The Phase I clearance for AN4035 is a positive catalyst for a first-in-class RAS-targeting ADC, but clinical risk remains high. Monitor IND approvals and initial safety/efficacy data from the Phase I trial. The prior $230M collaboration deal for AN9025 and $140M financing provide financial runway, reducing dilution risk near-term.
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Executive Summary
Adlai Nortye announced CTN submission and HREC approval to begin a Phase I trial of AN4035, a first-in-class pan-RAS(ON) inhibitor ADC targeting CEACAM5-enriched RAS-addicted solid tumors, in Australia. IND submissions to the U.S. FDA and China NMPA are also in process, with patient dosing expected in H2 2026. This milestone advances the company's RASiCA platform and pipeline, though Phase I carries high clinical risk.
Key Facts
- AN4035 is a first-in-class CEACAM5-targeting ADC armed with a pan-RAS(ON) inhibitor payload, cleared for clinical development in Australia.
- CTN submitted to TGA and HREC approval received for a global Phase I trial evaluating AN4035 as monotherapy and in combination with cetuximab.
- IND applications for AN4035 are being filed with the U.S. FDA and China NMPA.
- Preclinical data showed nanomolar to picomolar cytotoxicity, deep tumor regression in CDX/PDX models, and a favorable therapeutic index.
- Patient dosing is expected to begin in the second half of 2026.
Financial Impact
No financial figures provided; pipeline value enhancement for AN4035 with no near-term revenue impact.
Risk Factors
- Phase I clinical trial failure due to safety or efficacy issues.
- Regulatory delays in U.S. or China IND approvals.
- Competition from other RAS-targeting therapies and ADCs.
Market Snapshot
Investment Themes
Documents Analyzed
This report is based on 5 SEC documents filed with EDGAR.
| Document | Accession Number |
|---|---|
| 6-K Filing (Primary) | 0001213900-26-084256 |
| Document: ea0299478-6k_adlai.htm | 0001213900-26-084256 |
| Document: 0001213900-26-084256-index-headers.html | 0001213900-26-084256 |
| Document: 0001213900-26-084256-index.html | 0001213900-26-084256 |
| Document: 0001213900-26-084256.txt | 0001213900-26-084256 |
Filters
| Type | Now | ||||
|---|---|---|---|---|---|
Oct 15, 2026 12d ago | 6-K | $12.09 $10.58 | ▼ −12.49% | ▼ −11.48% | $10.73 (−11.25%) |
Oct 15, 2026 12d ago | Press Release | $12.09 $10.58 | ▼ −12.49% | ▼ −11.48% | $10.73 (−11.25%) |
Sep 30, 2026 27d ago | 6-K | $16.00 $14.05 | ▼ −12.19% | ▼ −14.10% | $10.73 (−32.94%) |
Sep 30, 2026 27d ago | 6-K | $16.00 $14.05 | ▼ −12.19% | ▼ −14.10% | $10.73 (−32.94%) |
Sep 16, 2026 5w ago | EFFECT | $15.52 $15.75 | ▲ +1.48% | ▼ −0.34% | $10.73 (−30.86%) |
Aug 26, 2026 8w ago | 6-K | $15.06 $13.86 | ▼ −8.00% | ▼ −7.88% | $10.73 (−28.75%) |
Aug 19, 2026 9w ago | 6-K | $14.33 $15.06 | ▲ +5.09% | ▲ +5.48% | $10.73 (−25.12%) |
Aug 14, 2026 10w ago | 6-K | $13.25 $13.70 | ▲ +3.40% | ▲ +4.76% | $10.73 (−19.02%) |
Aug 14, 2026 10w ago | Press Release | $13.25 $13.70 | ▲ +3.40% | ▲ +4.76% | $10.73 (−19.02%) |
Aug 3, 2026 12w ago | 6-K | $12.99 $13.23 | ▲ +1.85% | ▼ −0.18% | $10.73 (−17.40%) |
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