BioXcel Therapeutics has raised $260 million in funding to support the commercial activities of its proprietary, orally dissolving film formulation IGALMI.
Previously known as BXCL501, IGALMI is an orally dissolving film formulation of dexmedetomidine indicated for the acute treatment of agitation associated with schizophrenia or bipolar I or II disorder in adults.
The funding comes through strategic financing agreements from Oaktree Capital Management and the Qatar Investment Authority (QIA).
The funding will be used to support the commercial activities of IGALMI and also help expand clinical developments for the therapy which will include a pivotal Phase III programme for the acute treatment of agitation in patients with Alzheimer’s Disease (AD), and for the company’s additional neuroscience and immune-oncology clinical programmes.
Key features of the financing deals include:
- Credit Agreement: Up to $135 million in a delayed draw term loan.
- Revenue Interest Financing Agreement: Up to $120 million in a capped revenue interest on net sales of IGALMI and any other future BXCL501 products.
- Equity Investment: Up to $5 million purchase of BioXcel Therapeutics common stock.
Under the agreement, BioXcel Therapeutics will receive $100 million in the first tranches of the strategic financing following approval by the US Food and Drug Administration (FDA) of a New Drug Application (NDA) in respect of the use of the company’s BXCL501 product for the acute treatment of agitation associated with schizophrenia or bipolar I or II disorder in adults. This condition was satisfied on April 5, 2022 with the FDA’s approval of IGALMI.
“Following our recent approval of IGALMI and today’s financing announcement, we have never been in a better position to realise our vision of becoming the leading AI-enabled neuroscience company,” said Vimal Mehta, CEO of BioXcel Therapeutics. “We are pleased to have strengthened our cash position with primarily non-dilutive capital as we prepare to launch IGALMI and progress our three-pillar portfolio growth strategy for this franchise, which includes pursuing additional indications, extending our geographical reach, and expanding the medical settings where IGALMI is offered. In parallel, we remain committed to advancing our additional neuroscience and immuno-oncology portfolio, including BXCL502 and BXCL701.”
“We are delighted to partner with BioXcel Therapeutics during this upcoming period of anticipated growth, highlighted by the recent approval and anticipated commercial launch of IGALMI as an acute treatment of agitation associated with schizophrenia or bipolar I or II disorder in adults,” said Aman Kumar, Co-Portfolio Manager of Life Sciences Lending at Oaktree. “The company has an exciting, AI-driven approach to drug discovery and development, and we look forward to funding the expansion of these efforts and assisting the company in bringing new, innovative therapies to patients worldwide.”