Wesana Health Holdings Inc. announced that following the completion of a successful Pre-IND meeting with the United States Food and Drug Administration (“FDA”), the company is expanding its lead indication for SANA-013 to Major Depressive Disorder (“MDD”) and exploring other complementary orphan indications. Consistent with the positive feedback received from FDA, Wesana will accelerate the development of SANA-013 by initiating a Phase 1b/2a human study for MDD in the first half of 2023. In contrast to the prior development pathway for SANA-013 with TBI associated depression as the lead indication, the revised development pathway would allow the Company to bypass the healthy patient population study and research an MDD affected patient population directly as part of a Phase 1b/2a study. Wesana’s SANA-013 is designed to deliver a novel depression treatment protocol that includes a single high dose of psilocybin followed by a maintenance regimen of a non-hallucinogenic dose of psilocybin combined with cannabidiol (CBD). The low, non-hallucinogenic dose of psilocybin in combination with CBD is being developed for MDD and other indications so that affected people can benefit from a chronic, at-home use proposition.