Key Highlights

  • Shares traded at $0.975, up 8.33%, during the Trading session on 30 October 2026.
  • The first patient was enrolled in the Phase 2 CERE-CALM trial shortly after the September 2026 quarter end.
  • Cash and cash equivalents were $7.1 million at 30 September 2026, following a $692,578 grant Tranche received in October.

Ceretas Ltd (ASX:CTS) shares traded at $0.975 during the trading session on 30 October 2026, rising 8.33%. The S&P/ASX 200 (ASX:XJO) was at 8,973.00, up 0.91% or 81.20 points at 11:15 am. Ceretas is a clinical-stage medical technology company developing a portable, non-invasive therapeutic ultrasound platform for Alzheimer's disease and other neurodegenerative conditions. Its quarterly activities report and Appendix 4C for the quarter ended 30 September 2026 was released on 30 October 2026, the same day as the share move, so the two are discussed together.

Latest Development: Quarterly Report and Trial Start (30 October 2026)

The company completed its initial public offering of $8 million at $0.25 per share and commenced trading on the Australian Securities Exchange in July 2026. The offer was stated to fully fund the Phase 2 CERE-CALM trial and a preclinical blood-brain barrier opening program. Following quarter end, Ceretas enrolled its first patient in CERE-CALM at Cognivus Research in Sydney.

Ceretas also completed Milestone 3 of the CUREator+ program, which delivered functional prototypes of proprietary neuronavigation software and a lift assist device. The completion of that milestone triggered the final $692,578 non-dilutive funding tranche under the $2.4 million grant, received in October 2026.

Trial Design and Ethics Approvals

CERE-CALM is a randomised, double-blind, sham-controlled Phase 2 trial targeting 66 participants, randomised two to one between active treatment and sham. The primary endpoint is the change in overall neuropsychiatric symptom burden from baseline to week six. Additional ethics approval was secured for St Vincent's Hospital Sydney and John Hunter Medical Research Institute.

The company's Phase 1 study, conducted by researchers at the University of Queensland, involved 12 Alzheimer's patients and reported no ultrasound-related adverse events. The company's disclosures describe the Phase 1 results as encouraging but early.

Sector Context

Neuromodulation and focused ultrasound are developing areas of research into treatments for dementia-related symptoms. Trials in this area must meet regulatory and ethics requirements before enrolment, and results are typically judged across several endpoints and patient populations. The company operates alongside a separate Phase 2 trial, AGIFUS, run by university researchers and funded by Queensland Health.

Risks

The trial is at an early stage and has only just begun recruitment, so no efficacy results are yet available. Clinical outcomes, regulatory approval and the commercial use of the technology are not assured. Cash used in Operating Activities was $1.3 million for the quarter, and the company's cash runway is estimated at 5.4 quarters on the Appendix 4C basis. The release also shows a large difference between the prospectus use of funds estimate and actual spending since admission, and the company notes the two periods are not directly comparable.

What Lies Ahead

The company expects patient recruitment to continue at Cognivus Research and to commence at St Vincent's Hospital Sydney and John Hunter Medical Research Institute. Study completion at the first site is expected in the first half of CY2028, and the next-generation device program is on track for completion by mid-CY2027.

Closing Remarks

Ceretas' shares rose 8.33% during the 30 October 2026 session, the same day it reported the first patient enrolment in CERE-CALM and the completion of a grant milestone. The trial's progress and the next-generation device work will be the points to follow in coming reports.