AdAlta (1AD) Q1 2027 TU earnings summary

Executive summary

• EW-001 advanced toward its first US FDA regulatory advice and first Australian manufacturing runs, supporting the “East to West” development strategy.

• Clinical follow-up showed durable responses in China; Hainan regulators approved EW-001 for special access, while the program remains unapproved for general commercial launch.

Financial highlights

• September-quarter net cash used in operating activities was A$0.584 million after a A$0.231 million R&D Tax Incentive refund; cash and cash equivalents ended at A$0.648 million.

• Operating payments before the refund were ~A$0.81 million, down from A$1.84 million in the prior quarter, which included a non-recurring US$1 million payment to SHcell for trial costs and manufacturing materials.

• An Advance Overseas Finding is expected to support R&D Tax Incentive inflows exceeding A$1 million in the December quarter.

Outlook and guidance

• The pre-IND meeting is scheduled for 4 November 2026 AEST; FDA written minutes are generally issued two to four weeks after the meeting.

• First Australian EW-001 manufacturing runs at CTPL remain expected in H2 2026; further R&D Tax Incentive inflows are expected in the December quarter.

• The next formal assessments for two patients still on study are expected in Q1 2027; the second complete responder is among them.