Key Highlights

• The ASX-listed biotech described the meeting, announced on 23 September 2026, as its first significant engagement with the FDA on EW-001.

• It is important to be clear about what this milestone is and is not.

• A pre-IND meeting is a consultation, not an approval.

• It gives a drug developer the chance to put its plans in front of FDA reviewers and receive feedback before filing the formal IND application that is required to run Clinical Trials under FDA oversight.

AdAlta Limited (ASX:1AD) has told the market that the US Food and Drug Administration (FDA) has accepted its request for a pre-Investigational New Drug (pre-IND) meeting on EW-001, the company's lead CAR-T cell therapy for advanced mesothelioma and other cancers that express the protein mesothelin. The ASX-listed biotech described the meeting, announced on 23 September 2026, as its first significant engagement with the FDA on EW-001.

It is important to be clear about what this milestone is and is not. A pre-IND meeting is a consultation, not an approval. It gives a drug developer the chance to put its plans in front of FDA reviewers and receive feedback before filing the formal IND application that is required to run clinical trials under FDA oversight. EW-001 has not been approved for commercial use anywhere in the world.

What AdAlta announced

According to the announcement, the virtual face-to-face pre-IND meeting is scheduled for 3 November 2026 US time, which is 4 November 2026 AEST. AdAlta said the FDA generally issues formal written minutes two to four weeks after such a meeting.

To request the meeting, AdAlta had to prepare a detailed briefing document setting out what the product is, how it is made and tested, what is already known about its safety and effectiveness, and what the company plans to do next, particularly in patients. AdAlta said being in a position to prepare that document was the real achievement behind the announcement. Its specialist regulatory advisers, Dark Horse Consulting Group, are supporting preparation of the briefing document and the meeting itself.

Three workstreams behind the briefing document

AdAlta said three separate bodies of work had to come together before the briefing document could be written.

The first was data from Shanghai. Hundreds of new documents have been transferred from co-development partner Shanghai Cell Therapy Group Co Ltd (SHcell) under the parties' Development and Collaboration Agreement. The company said these covered Manufacturing methods, quality and release testing, laboratory and animal study reports, and patient-by-patient results from investigator-initiated trials conducted in China.

The second was a clinical protocol for Australia. Working with its clinical advisory board, drawn from Australian CAR-T and mesothelioma treatment centres, AdAlta has produced a draft Phase 1 clinical trial protocol covering which patients would be included, what doses they would receive, how safety would be monitored and what outcomes would be measured.

The third was manufacturing. AdAlta is working with contract manufacturer Cell Therapies Pty Ltd on technology transfer and process optimisation to establish how EW-001 will be made in Melbourne to the standards the FDA expects.

What the meeting is expected to inform

The company said it expects the FDA's feedback to provide input across three areas. On manufacturing, it is seeking to confirm the testing, comparability and release strategy for EW-001 made in Australia, and how far manufacturing improvements can be made before Phase 1 trials begin. On non-clinical work, it wants to confirm which laboratory and animal studies are still required and where existing data generated in China can be relied upon. On clinical design, the discussion is expected to cover the patient population, starting dose, dose escalation scheme and safety monitoring arrangements.

AdAlta said obtaining feedback now means any FDA concerns are understood early, so additional data can be generated and included in the formal IND submission rather than causing delays and added cost later.

What management said

AdAlta CEO and Managing Director Dr Tim Oldham said: "The FDA agreeing to meet us is the headline. What matters more is what it took to reach the point where we could request the meeting."

He added that a pre-IND briefing document "is only possible once all of those pieces exist and fit together, so this is a milestone for the whole program and for our partners, not just for our regulatory team."

Dr Oldham also said that, consistent with its Capital efficient approach, the company now gets "to test our thinking with the world's most experienced regulator of cell therapies before we commit to the costliest parts of the program."

Background on EW-001 and the East to West strategy

EW-001, formerly known as BZDS1901, is described by AdAlta as a first-in-class CAR-T therapy targeting mesothelin, a protein highly expressed in many cancers. The company said it is also engineered to produce a checkpoint inhibitor protein designed to protect the CAR-T cells from a key defensive mechanism used by cancers. Mesothelioma is a rare but rapidly fatal cancer usually linked to asbestos exposure.

That report said the arrangement included a minimum Stage 1 commitment of US$15 million and a planned Phase 1 trial in Australia.

The company reported that EW-001 studies in China in relapsed or advanced mesothelioma patients have shown up to a 50% overall response rate and up to a 20% complete response rate. These are early results from investigator-initiated studies, and the company itself notes that EW-001 has not received regulatory approval for commercial launch anywhere.

AdAlta's broader "East to West" strategy involves in-licensing cell therapies from Asian originators, establishing FDA-regulated manufacturing and running Phase 1 studies in Australia, with the aim of positioning products for on-licensing to larger biopharmaceutical companies. The company said holding this meeting shows that strategy "working in practice".

Risks and considerations

A pre-IND meeting does not guarantee that the FDA will agree with AdAlta's proposals, and the company acknowledged that, depending on the nature and scope of the feedback, it will need further time to work through any implications for its manufacturing, non-clinical and clinical plans. That could affect timelines. The formal IND submission, IND-enabling studies and the Phase 1 trial all still lie ahead, and clinical results from China may not be replicated in a new trial or patient population. Cell therapy manufacturing and technology transfer also carry execution risk, and development of this kind typically requires ongoing funding.

What comes next

The next milestone for investors following ASX shares in the biotech sector is the 4 November 2026 (AEST) meeting, followed by the FDA's written minutes. AdAlta said it will update the market as appropriate once it has worked through the feedback.

The bottom line

AdAlta's pre-IND meeting marks the first formal FDA engagement for EW-001 and brings together data transfer, protocol design and manufacturing work. It is an early regulatory step rather than an approval, and the outcome of the November discussion will shape the program's path towards an IND submission and a first Phase 1 trial.