Psyence is in the advanced planning stages for a Phase 2b clinical trial focused on psilocybin-assisted psychotherapy for patients with adjustment disorders related to recent terminal cancer diagnoses. The trial, which is a collaborative venture with Australia-based iNGENu CRO, is set to take place in Australia where new regulations came into effect on July 1 that permit controlled clinical use of psilocybin and Methylenedioxy-methamphetamine (MDMA) for certain mental health disorders.
Psyence also obtained an expanded worldwide licensing agreement to commercialize a psilocybin capsule, PEX010 (25 milligram), for use in palliative care from Filament Health (OTCQB: FLHLF). The agreement extends a previous research licensing agreement and gives Psyence exclusivity in key markets, including the United States, the European Union, and the United Kingdom.
Additionally, the company said it successfully exported medical-grade psilocybin mushrooms to Canada, Portugal, and the United Kingdom. The milestones align with the company’s mission to develop global partnerships to supply pharmaceutical-grade psilocybin products for research, clinical trials, and drug development.
The company’s production facility, which it touts as one of the first government-licensed commercial psilocybin facilities in southern Africa, is currently undergoing an upgrade, with new extraction equipment scheduled to be installed in the third quarter.
Psyence said its partnership with extraction and distillation company Eden Labs bolsters the expansion, allowing the production of a “stabilized, naturally derived psilocybin powder.”
Psyence also reported a successful merger between its clinical trail division Psyence Biomed Corp. and Nasdaq-listed Newcourt Acquisition Corp. The merger is expected to conclude in the second half of 2023, with the combined company set to list on the Nasdaq.
Psyence stretched its fiscal runway a bit after brokering a March financing agreement with Cantheon Capital worth $1.39 million, of which the first half has already been doled out.
The company additionally raised more than C$3.04 million since the fourth quarter of 2022 from various sources. It used part of that funding to pay off a debt it owed, which had previously been turned into a convertible note.
“The company does not have any debt on its balance sheet since the conversion of the note,” Psyence said in a statement. The company also canceled roughly 5.7 million stock options.
CEO Neil Maresky lauded the significant progress and noted the importance of the upcoming clinical trial in Australia, stating that the company was “firmly on track” and looking forward to executing its strategy for the remainder of 2023.