AdAlta
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AdAlta (1AD) investor relations material

AdAlta Q1 2027 TU earnings summary

Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.
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Q1 2027 TU earnings summary25 Oct, 2026

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.

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Frequently asked questions

AdAlta Limited is an Australian biotechnology company focused on the discovery and development of novel protein-based therapeutics. The company utilizes its proprietary i-body technology platform to create next-generation biologic drugs targeting a range of diseases, including fibrosis and immune-related conditions. AdAlta Limited is headquartered in Melbourne, Australia, and its shares are listed on the ASX.