Cybin Inc

NASDAQ:HELP

Pipeline Progress: Cybin completed over 140 preclinical studies since early 2021, with more than 50 in January 2022 alone, accelerating its clinical development pipeline.

Clinical Trial Plans: The company plans to file an IND for its lead candidate, CYB003, in Q2 2022 and start a Phase I/IIa trial in major depressive disorder (MDD) patients around midyear, expecting initial PK and safety data by year-end.

Intellectual Property: Cybin received its first U.S. patent for CYB004, a deuterated DMT molecule, providing protection until 2041 and supporting its anxiety disorder program.

Financial Update: The company ended Q3 with $63.6 million in cash and equivalents, while operating expenses for the quarter were $12 million (including $2.5 million in one-time costs), and reported a net loss of $17.2 million.

Regulatory Engagement: Cybin had a productive meeting with the UK MHRA for CYB003 but does not expect a pre-IND meeting with the FDA; plans to file the IND in Q2 2022.

Strategic Focus: The company shifted from a sublingual psilocybin program to proprietary analogs (CYB003, CYB004, CYB005) to enhance scalability, efficacy, and intellectual property position.