Disclosure Delays in AML Trial Data Raise Questions on Biotech Reporting Risks
Chimeric Therapeutics has responded to ASX inquiries regarding the disclosure timing and materiality of new clinical data from its ADVENT-AML trial, emphasizing compliance with continuous disclosure rules and the careful verification of promising patient responses.
- No dose-limiting toxicities or severe adverse events reported in dose escalation phase
- CORE-NK cells showed persistence in patients’ blood beyond two weeks
- Two new complete responses in frontline AML patients confirmed post-conference
- Company verified data with MD Anderson Cancer Center before ASX announcement
- CHM affirms compliance with ASX Listing Rules on continuous disclosure
Background on ADVENT-AML Trial
Chimeric Therapeutics Limited (ASX, CHM) has recently addressed an ASX query concerning the timing and substance of disclosures related to its ADVENT-AML clinical trial. This trial, conducted in collaboration with the MD Anderson Cancer Center, investigates the safety and efficacy of combining the company’s CORE-NK cell therapy with standard treatments azacitidine and venetoclax in patients with acute myeloid leukemia (AML).
The dose escalation phase enrolled six patients with relapsed or refractory AML, focusing primarily on safety endpoints. Encouragingly, the trial reported no dose-limiting toxicities, cytokine release syndrome, neurotoxicity, or graft-versus-host disease, underscoring a favourable safety profile for the novel combination.
Clinical Efficacy and New Data Disclosures
One of the six patients achieved a complete response (CR) during the dose escalation phase, with CORE-NK cells persisting in the bloodstream for over two weeks after repeated infusions. More notably, subsequent data from the ongoing frontline cohort; comprising seven high-risk newly diagnosed AML patients; revealed four clinical responses, including two additional complete responses and one complete response with incomplete count recovery.
These new complete responses were not part of the data presented at the Society of Hematology Oncology Annual Meeting held between 3 and 6 September 2025. Chimeric Therapeutics only became aware of this new information on 27 September 2025, after which it undertook a rigorous verification process with MD Anderson Cancer Center experts. This process included detailed clinical data analysis and expert confirmation, culminating in a market announcement on 2 October 2025 prior to market open.
Compliance with ASX Continuous Disclosure Obligations
The ASX’s query focused on whether the timing of disclosures complied with Listing Rules 3.1 and 15.7, which require immediate release of material information. Chimeric Therapeutics affirmed that the new clinical data; particularly the two additional complete responses; were not known or disclosed at the time of the conference poster presentation and thus were not prematurely released.
The company emphasized its commitment to accuracy and completeness, noting the necessity of expert verification before announcing such significant clinical outcomes. This cautious approach aligns with the ASX Code of Best Practice for Reporting by Life Sciences Companies, which stresses the importance of avoiding misleading or promotional disclosures.
Implications for Investors and Next Steps
While the safety and early efficacy signals from the ADVENT-AML trial are promising, the company’s detailed response highlights the complexities of clinical data disclosure in the biotech sector. Investors should appreciate the balance between timely information release and the need for rigorous data validation to maintain market integrity.
Looking ahead, further trial results, especially from the frontline cohort, will be critical to assess the potential commercial and regulatory impact of CHM’s CORE-NK therapy. The company’s transparent handling of ASX’s query may bolster investor confidence in its governance and disclosure practices.
Bottom Line?
Chimeric Therapeutics’ measured disclosure approach underscores the delicate balance between clinical data transparency and regulatory compliance in biotech innovation.
Questions in the middle?
- How will upcoming ADVENT-AML trial phases influence CHM’s valuation and investor sentiment?
- What are the long-term efficacy and safety prospects of CORE-NK therapy in frontline AML patients?
- Could the timing of disclosures affect CHM’s future market access or partnerships?
