Highlights

  • The US FDA accepted a pre-IND meeting for EW-001, scheduled for 3 November 2026 (US time).
  • Hainan regulators approved EW-001 for eligible advanced mesothelioma patients under a special access scheme.
  • The first complete responder passed two years without recurrence.
  • Cash was A$648,000 at quarter end, with R&D tax incentive inflows above A$1 million expected in the December quarter.

AdAlta Limited (ASX:1AD) has released its quarterly activities report for the September 2026 quarter. The company made regulatory progress on EW-001, its CAR-T cell therapy for mesothelioma, including securing its first formal meeting with the US Food and Drug Administration.

Regulatory Progress for EW-001

The FDA accepted AdAlta's pre-IND meeting request in September 2026, with the meeting scheduled for 3 November 2026 US time. Written minutes are usually issued two to four weeks after the meeting. The briefing pack was approved by the EW-001 Joint Development Committee and submitted on schedule.

In September, regulators in Hainan approved EW-001 for eligible advanced mesothelioma patients at Ruijin Hospital under the Hainan Boao Lecheng scheme. AdAlta noted this is not full marketing approval in China and does not generate revenue. In Australia, first manufacturing runs at Cell Therapies Pty Ltd in Melbourne are expected in the second half of calendar 2026, and a draft Phase 1 protocol has been developed.

Clinical Updates from Investigator-Initiated Trials

The first complete responder passed two years without recurrence and has completed the study. In the investigator-initiated trials in China, three of ten patients treated at higher doses survived at least 12 months, and two patients remain on study, with further assessments expected in Q1 calendar 2027.

AdAlta noted that these early results come from small investigator-initiated trials rather than controlled studies, and EW-001 has not received approval for commercial launch in any market.

Corporate Developments and Cash Position

During the quarter, AdAlta opened a representative office in Shanghai and began a strategic collaboration with Oktopi. The company is also receiving partnering enquiries for AD-214 and evaluating funding options for WD-34, including a possible spin-out.

AdAlta held A$648,000 in cash at 30 September 2026, compared with A$1.28 million at the start of the quarter. Net operating outflows were A$584,000 after a A$231,000 R&D tax incentive refund. The company received an Advance Overseas Finding on 19 October 2026 and expects R&D tax incentive inflows above A$1 million in the December quarter. It reported 1.1 quarters of estimated funding. The AGM will be held on 25 November 2026.

Key Takeaways

  • The FDA pre-IND meeting marks EW-001's first formal US regulatory engagement.
  • Early clinical data remain encouraging but are based on small, uncontrolled studies.
  • Funding is a key focus, with the company relying on expected R&D tax incentive inflows and partnering initiatives.