Key Highlights

  • All six Cohort 1 patients kept a clinically meaningful response at 12 weeks, and three of six (50%) had no binge-eating episodes across 84 days.
  • Weekly binge-eating episodes stayed 73% below baseline at 12 weeks, against a 74% reduction at four weeks.
  • HREC approval covers a Phase 1b/2a basket study of up to 72 patients across eight indications.
  • Net operating cash outflow was $1.8 million for the quarter, with about $6.2 million in cash and funding facilities and a $2 million R&D Tax Incentive refund expected.

Entropy Neurodynamics Limited (ASX:ENP) reported clinical, regulatory and manufacturing progress for its IV-infused psilocin program, TRP-8803, in the quarter ended 30 September 2026. Cohort 1 of the Phase 2 binge eating disorder study kept all six treatment-resistant patients in clinically meaningful response through 12 weeks. The company also gained ethics approval for an eight-indication Phase 1b/2a study, signed a pre-clinical trial agreement with the University of California, San Francisco, and appointed BioCina for GMP manufacturing.

Binge Eating Disorder Results Hold at 12 Weeks

Cohort 1 of the Phase 2 study, run with Swinburne University of Technology, treated six patients who had lived with binge eating disorder for a median of 15 years and had each failed at least one earlier treatment. All six met the primary and secondary efficacy endpoints, and 50% reached clinical remission. At four weeks, weekly binge-eating episodes were down 74%. At 12 weeks all six patients retained a clinically meaningful improvement, three of them (50%) recorded no binge-eating episodes over the full 84-day follow-up, and episodes remained 73% below baseline.

Other measures at 12 weeks showed a 50% reduction in anxiety (58% at four weeks), a 42% reduction in depression (57%), a 61% improvement in life satisfaction (63%) and a 44% improvement in Clinical Global Impression (33%). These outcomes followed two TRP-8803 infusions. The independent Data Safety Monitoring Board endorsed progression to Cohort 2 without changes to the protocol.

Cohort 2, Conference Data and the Shorter Infusion

After quarter end, the first Cohort 2 patient completed a 60-minute infusion, compared with 140 minutes in Cohort 1, and reported a maximum psychedelic intensity of 9/10. Cohort 2 is fully recruited, and topline results are expected by the end of calendar 2026. On 19 October, two posters were presented at the 39th ECNP Congress in Munich. They reported no serious adverse events or discontinuations across 12 dosing sessions in six patients, a mean peak intensity of 9.4/10, and peak intensity within 20 minutes in seven of the 12 sessions.

Eight-Indication Study, UCSF Pathway and Manufacturing

A Human Research Ethics Committee approved a Phase 1b/2a basket study of up to 72 patients. The indications are anorexia nervosa, body dysmorphic disorder, obsessive compulsive disorder, generalised anxiety disorder, post-traumatic stress disorder, treatment-resistant depression, fibromyalgia and irritable bowel syndrome. Treatment-resistant depression will be studied in two cohorts, one on antidepressants and one not. A new Clinical Trial Research Agreement with Swinburne supports the work.

Under a pre-Clinical Trial Agreement with UCSF, the company will sponsor a proposed FDA Investigational New Drug application and a US Phase 2 trial in major depressive disorder. The trial would compare TRP-8803 with escitalopram in up to 80 young adults, led by Professor Robin Carhart-Harris, with depression assessed at eight weeks and six months. Commencement is planned for the first half of calendar 2027, subject to approvals.

The company also signed a Development and Manufacturing Services Agreement with BioCina, which operates TGA-licensed facilities, covering analytical verification, engineering batches and GMP production of placebo and active drug product. Entropy retains full ownership of TRP-8803 intellectual property. Two patents were granted: Australian Standard Patent No. 2023/343417 for crystalline forms of psilocin on 10 July 2026, and South African Patent No. 2025/01722 for treating fibromyalgia on 20 July 2026, both running to September 2043.

Cash Position at Quarter End

Net operating cash outflow was $1.8 million, up from $1.4 million in the June quarter, mainly for research and development. Cash and equivalents ended at $3.626 million, down from $5.576 million. With an unused $2.6 million R&D loan facility with Rockford Equity, total available funding was $6.225 million, equal to 3.4 estimated quarters. A $2 million R&D Tax Incentive refund is expected in the current quarter. Payments to related parties were $258,000.