Ceretas takes Alzheimer’s ultrasound program into Phase 2 recruitment

Phase 2 Alzheimer’s trial moves into recruitment

Ceretas Limited (ASX:CTS) has moved its Alzheimer’s ultrasound program from preparation into active clinical recruitment, enrolling the first patient in the Phase 2 CERE-CALM trial shortly after the September quarter ended. The patient was recruited at Cognivus Research in Sydney, with recruitment expected to begin shortly at St Vincent’s Hospital Sydney and John Hunter Medical Research Institute.

CERE-CALM is a randomised, double-blind, sham-controlled study targeting at least 60 of a planned 66 participants. It will test low-intensity focused ultrasound neuromodulation in Alzheimer’s patients with behavioural and psychological symptoms of dementia, with the primary endpoint measuring the change in Neuropsychiatric Inventory scores from baseline to six weeks. Study completion is expected in the first half of calendar 2028.

The program builds on a 12-person Phase 1 study in which Ceretas says the treatment was safe and well tolerated, with no ultrasound-related adverse events. Ten participants recorded lower Neuropsychiatric Inventory scores, although the company’s own disclosure notes that the two participants without a decrease had no symptoms at baseline. That early signal is encouraging but remains a small, preliminary dataset rather than proof of efficacy.

IPO cash funds clinical and device programs

The trial is being funded by Ceretas’ $8 million July IPO, completed at $0.25 a share before the company began trading on the ASX on 23 July. Ceretas ended the quarter with $7.1 million in cash and cash equivalents, after using $1.3 million in operating activities and $210,000 on investing activities. At the quarter’s reported operating cash burn, the Appendix 4C indicated about 5.4 quarters of available funding.

Cash use since ASX admission included $516,098 on the CERE-CALM trial, $168,307 on next-generation device development and $23,212 on preclinical blood-brain barrier opening studies. The company also reported $613,000 in equity-issue transaction costs during the quarter, while the IPO proceeds contributed $8 million in financing inflows. The runway estimate is therefore a snapshot based on current spending, not a guarantee that future trial and development costs will remain at the same level.

Device milestone unlocks final grant tranche

Ceretas also completed Milestone 3 under the $2.4 million CUREator+ Dementia & Cognitive Decline program, delivering functional prototypes of proprietary image-guided neuronavigation software and a collaborative lift assist device. The work, previously reported as the CUREator+ device milestone, was accepted by Brandon BioCatalyst and triggered the final $692,578 non-dilutive funding tranche, which Ceretas received in October.

The in-house navigation software is intended to replace an off-the-shelf system and reduce the number of operators required for treatment from two to one, while the lift assist device is designed to help position the ultrasound probe steadily on a patient’s head. Ceretas says the broader next-generation device program remains on track for completion by mid-2027. Separately, the company has secured full legal and beneficial ownership of its core intellectual property from UniQuest in exchange for 1 million shares and a nominal fee.

Beyond CERE-CALM, the independently funded AGIFUS Phase 2 trial is expected to begin recruiting by the end of calendar 2026 and will evaluate the technology in agitation associated with moderate-to-severe Alzheimer’s disease. Ceretas is also pursuing preclinical blood-brain barrier opening research, with data expected in 2027 and a first-in-human study targeted for 2028, alongside planned FDA regulatory engagement in the second half of 2026.