Psyence Group Inc.
WKN: A2QNE2 | ISIN: CA74449Q1063 | CSE: PSYG | OTCQB: PSYGF
Psyence is a life science biotechnology company. Psyence works with natural psilocybin products for the healing of psychological trauma and its mental health consequences in the context of palliative care.
Psyence is focused on developing proprietary natural psilocybin drug development and treatment protocols. Psyence is developing market leading clinical trials in the field of palliative care.
Clinical trial programme
Psyence’s clinical trials will assess the safety and efficacy of psilocybin-assisted psychotherapy versus psychotherapy alone for the treatment of adjustment disorder due to an incurable cancer diagnosis in a palliative care context.
In the United Kingdom, Psyence has partnered with Clerkenwell Health, a leading psychedelic contract research organisation (CRO). Clerkenwell will be responsible for jointly designing and delivering Psyence’s UK clinical trials in the future. Psyence has received Phase IIa clinical trial approval from the UK Medicines and Healthcare Products Regulatory Agency (in September 2022) to commence its UK clinical trial.
Psyence has also signed a Letter of Intent (LOI) with iNGENū CRO, a globally focused CRO with extensive experience in working in the psychedelic pharmaceutical drug development and clinical research industry. iNGENū will be responsible for jointly designing Psyence’s Phase IIb clinical trial to be conducted in Australia. The LOI centres around Psyence’s global development and regulatory strategy of its licensed compound PEX010 in palliative care in Phase II clinical trials. The prospective cooperation and trial would potentially reduce Psyence’s timeline for starting a Phase III registrational clinical trial.
On 9 January 2023, Psyence Biomed, a wholly owned subsidiary of Psyence Group, announced that it has entered into a definitive business combination agreement with Newcourt Acquisition Corp (Nasdaq: NCAC) to create a public company leveraging psilocybin in the treatment of palliative care. Psyence biomed is Psyence’s clinical trial division. The combined company would be capitalized with a minimum of US$ 20 million, have access to Nasdaq listed Newcourt shareholders, promoters, and advisors. The business combination is anticipated to conclude in the first half of 2023 with the combined company to go public. The funding from the transaction will enable Psyence to execute its early-stage development programme in palliative care.
Licensed producer of psilocybin
Psyence operates one of the first and only federally licensed commercial psilocybin production facilities in the world. Its facility, located in Southern Africa, is ISO22000 certified and is licensed to cultivate and export psilocybin mushrooms for the legal, global medical market and commercial medical research market.