PSIL-006 / Psilera - LARVOL DELTA

Psilera Inc. & atai Life Sciences Announce Licensing Agreement for DMT Patent Portfolio (PRNewswire) - "Psilera, Inc...today announced a licensing agreement (the 'Agreement') under which atai has acquired Psilera's DMT (N,N-dimethyltryptamine) patent portfolio, including all granted and pending patents related to DMT and other related psychedelics...Psilera will continue to expand its pipeline of novel neuroplastogens compounds while advancing PSIL-006 to the clinic for first-in-human trials expected in 2026."

Commercial • New P1 trial • CNS Disorders

Psilera receives positive preclinical in vivo data for frontotemporal dementia (FTD) candidate, PSIL-006 (PRNewswire) - "Psilera...has received initial toxicity readouts from maximum tolerated dose (MTD) in vivo studies showing a strong safety profile. Additional preclinical in vivo efficacy studies, conducted through the University of South Florida, have shown PSIL-006's ability to improve the sleep, learning, and memory in humanized Tau mouse models....Bolstered by the latest preclinical data, Psilera is poised to advance their lead asset, PSIL-006, towards first-in-human studies for Frontotemporal Dementia (FTD)."

Preclinical • CNS Disorders • Dementia

Psilera Announces Lead Indication for PSIL-006: Behavioral Variant Frontotemporal Dementia (bvFTD) (PRNewswire) - "Psilera...is pleased to announce the selection of behavioral variant frontotemporal dementia (bvFTD) as the lead indication for its groundbreaking drug candidate, PSIL-006. This devastating form of early-onset dementia currently lacks approved treatments to manage symptoms or slow disease progression....Psilera remains dedicated to advancing the development of PSIL-006 and is actively engaged in preclinical studies to further evaluate its safety and efficacy. The company is committed to collaborating with regulatory authorities, healthcare professionals, and patient advocacy groups to ensure the successful development of PSIL-006."

New indication • CNS Disorders • Dementia • Frontotemporal Lobar Degeneration