George Pappas
Sep 30, 2024
The $2.9M follows grant from the National Institute on Drug Abuse enables Delphian to use its Seed Financing toward a phase 1 clinical trial.
September 30, 2024
Last week, the U.S. National Institutes of Health awarded us a $2.9M SBIR Grant toward developing S1-220, our patented, optimized CBD:THC formulation to treat migraine, one of the world's largest diseases. This has a number of very exciting implications.
First, this new $2.9M NIH grant will take us through FDA Investigational New Drug (IND) clearance to begin Phase 1 clinical trials in 2025. This means that our ~$3M Seed Financing, raised in 2023/24, could not only complete our Phase 1 trial, but can also be used to expand our pipeline into other indications beyond migraine.
It also means that our Series A financing next year will now drive completion of Phase 2 clinical trials, targeted to begin by early 2026. As many of you know, after Phase 2 is the point at which many biotech companies either go public or get acquired. Eli LIlly acquired the migraine drug Lasmiditan after phase 2, while in phase 3, for $960 million.
Now that the US Government has invested in us so heavily, we are in a whole new category of eligibility for other large grants. We've already started identifying grant opportunities in the US and EU to support not only our Phase 2 trials, but related R&D in and around the science of optimized cannabinoid therapeutics. This will generate more IP and increase our moat as a leader in this new drug class which has enormous potential to treat diseases across therapeutic areas.
Over the next 12-18 months we'll be fast transitioning from a younger, pre-clinical company into a more mature, clinical-stage company recognized as a world-leader in optimized cannabinoid therapies. We'll have one of the world’s largest indications well into clinical trials, with an expanding pipeline of drugs in development, just as federal rescheduling of cannabis is expected to catapult cannabinoid R&D toward FDA-approved medicines.