aibioAdlai Nortye drops buparlisib after Phase III miss, plans workforce cut to preserve cash
Tickers ANL
Adlai Nortye's Phase III BURAN trial of buparlisib missed its overall survival endpoint, the company is dropping the drug, and it plans to cut staff "to preserve cash," with the release giving no survival figures.
Key facts
- Company
- Adlai Nortye Group Ltd. (NASDAQ: ANL)
- News type
- Distress
- Primary source
- Adlai Nortye Group Ltd. 6-K (2025-05-30)
Adlai Nortye Ltd. (NASDAQ: ANL), a Cayman Islands company with global research centers in the United States and China, reported topline results on May 30, 2025 from its Phase III BURAN trial. The trial tested buparlisib, a PI3K inhibitor, with paclitaxel in patients with recurrent or metastatic head and neck squamous cell carcinoma, HNSCC, who had progressed after anti-PD-(L)1 treatment. The company said the study did not meet its primary endpoint of improving overall survival compared with paclitaxel alone. A total of 487 patients were enrolled globally.
The trial was randomized 2:1 and open-label, which means patients and doctors knew which treatment was being given. The release gives no hazard ratio, median survival for either arm, or confidence interval, and does not say how the secondary endpoints of progression-free survival, objective response rate and duration of response came out. It says detailed results will be presented at an upcoming medical conference. It describes the Phase III as building on positive Phase II data, which it says preceded the establishment of anti-PD-(L)1 therapies as the cornerstone treatment for recurrent or metastatic HNSCC.
The company says buparlisib's safety profile was consistent with previous findings, with no new safety signals observed. Based on the outcome, it has decided to discontinue further development of the drug. Chief Executive Carsten Lu said the company will continue to analyze the data to understand the findings and to inform future drug development in HNSCC.
Cuts and cash
Lu said the company "expects to make near-term changes to its business operations and to reduce its workforce in order to preserve cash." The steps listed are optimizing workforce structure and compensation, pursuing strategic business development opportunities, and expanding its financing options. The release does not say how many jobs will be cut, what the cuts will cost, or which financing options are being pursued.
The annual report for 2024, filed as a 20-F on April 30, 2025 and amended on May 12, 2025, shows the financial pressure behind that decision. Research and development expense was $44.9 million in 2024, down from $58.2 million in 2023. The net loss was $51.9 million in 2024, against $109.2 million in 2023. Cash used in operations was $51.8 million in 2024 and $56.7 million in 2023. Revenue was $5.0 million in 2023.
Cash and cash equivalents were $60.9 million at December 31, 2024, down from $91.5 million a year earlier. The release gives no cash balance after 2024.
The pipeline left behind
Adlai Nortye says it will refocus on AN8025, a multifunctional fusion protein that acts as a T cell and antigen-presenting cell modulator, and on AN9025, an oral small-molecule pan-RAS(ON) inhibitor. The release says preclinical studies showed AN8025 enhances both the quantity and quality of antigen-presenting cells. It plans to submit an IND application for AN8025 in mid-2025 and for AN9025 in the second half of 2025.
The company also has AN4005, an oral small-molecule PD-L1 inhibitor. Preliminary results from its dose-escalation phase, presented at the 2024 SITC meeting, showed favorable safety and tolerability and encouraging preliminary efficacy in a tumor type known to respond to anti-PD-(L)1 therapy. The trial has moved to an expansion phase evaluating two doses in checkpoint inhibitor-naive patients, and proof-of-concept data are expected by the end of 2025. Those are preliminary data from an early-stage study, and the release does not give the size of the expansion cohort.
What the release does not show
The company's own description of buparlisib's safety is the only safety statement in the release, and the release gives no detailed efficacy data to check it against. The 20-F lists the general risk that adverse events could delay, halt or alter development of the company's drug candidates.
What comes next
The company says detailed BURAN results will be presented at a medical conference that has not been named. The planned IND filings and the AN4005 expansion data are the next milestones, and each depends on cash the company does not describe beyond its 2024 year-end balance.