FDA nod fuels Filament’s psychedelics push, but cash running short

A key regulatory green light cleared the way for  Filament Health Corp.’s (OTCQB: FLHLF)  lead psychedelics program in the latest first quarter as cash levels ticked down.

The clinical-stage biotech reported $872,048 in cash and equivalents as of March 31, after using $949,606 for operating activities in the fiscal first quarter of 2024. Total revenues for the quarter were $297,932, while working capital stood at $359,664.

Filament announced during the quarter that the U.S. Food and Drug Administration accepted its investigational new drug (IND) application for PEX010, the company’s botanical psilocybin drug candidate aimed at treating substance use disorders.

“This quarter we have continued to advance Filament’s drug development efforts in substance use disorders, as evidenced by the opening of our first IND with FDA in the United States,” CEO Benjamin Lightburn said in a statement.

With an FDA-approved IND in hand, Filament can now initiate clinical trials with PEX010 in the U.S. The company believes its pipeline of standardized, naturally-derived psychedelic medicines sourced from plants like psilocybin mushrooms could improve treatment across a range of mental health conditions.

During the quarter, Filament expanded global distribution of PEX010 to partners for clinical trials. It exported the drug candidate to research institutions in Canada, the U.S., Belgium and Israel for studies targeting indications such as depression, anxiety and cannabis and alcohol use disorders.

Lightburn noted PEX010 is now authorized for investigation in 31 clinical trials worldwide across 13 mental health indications. The company has licensing deals in place with firms like Reset Pharmaceuticals for development across multiple countries.