John SchroyerToronto-based Cybin Inc. (NYSE:CYBN) will be raising roughly $150 million through the private placement of more than 348 million common shares to continue funding operations and clinical trials, the company announced Wednesday.
A psychedelics firm that is still in the pre-revenue stage, the proceeds from the raise will be used to support “certain Phase 3 drug development activities for CYB003, working capital and general corporate purposes,” the company said in a release.
The CYB003 drug, which is based on psilocybin, is in the testing phase and is aimed at patients with major depressive disorder, but has yet to gain federal approval for widespread distribution in the U.S.
FDA
Separately, Cybin also told investors that the FDA has granted BTD (breakthrough therapy designation) to CYB003 for the adjunctive treatment of major depressive disorder (MDD). If approved by the FDA, CYB003 would be the first known adjunctive psychedelic-based therapeutic for the treatment of MDD.
Cybin noted that BTD is reserved for drug candidates that target serious conditions and demonstrate substantial improvement on a clinically significant endpoint over available therapies. The company said in a statement, “The designation includes all “fast track” program features, as well as more intensive FDA guidance and discussion of the CYB003 development program, including planned clinical trials and plans for expediting the manufacturing development strategy.”
“The granting of Breakthrough Therapy Designation by the FDA underscores the potential of CYB003 to fill a gap in the treatment landscape for MDD and serves to expedite and de-risk our development program going forward,” said CEO Doug Drysdale. “This designation provides for a streamlined review process and enhanced engagement with the FDA. With the robust durability data from our Phase 2 study in hand, we are ready to move forward expeditiously. We are grateful for the opportunity to accelerate the development and regulatory review process that this designation affords, as we prepare to advance CYB003 toward a Phase 3 pivotal trial around mid-year.”
Cash levels
Cybin had C$39 million in cash, or $28.9 million, at the end of its most recent fiscal quarter, along with access to C$121 million, the company previously reported.
But because it’s in the pre-revenue stage and thus far has no income, Cybin has also been burning through cash and posted a C$30.3 million loss for its most recent fiscal quarter, which ended on New Year’s Eve.
Cybin’s upcoming oversubscribed private placement will be led by Deep Track Capital and will include RA Capital Management, Avidity Partners, Acorn Bioventures, Altium Capital, Logos Capital, Octagon Capital, Rosalind Advisors, Sphera Healthcare, and other institutional investors, according to a press release.
The private placement is expected to close on March 19.
