Cybin Maintains Steady Runway, Finds Approval for DMT and Psilocybin Studies

The company received approval in the Netherlands to start dosing humans with one of its compounds.

Cybin Inc. (NEO: CYBN) (NYSE American: CYBN) made strides in its active branded drug programs looking to treat anxiety and major depressive disorders.

The Toronto-based biotech company, which became the first psychedelic biotech company to list its stock on the New York Stock Exchange, reported its unaudited financials for its third quarter ending Dec. 31, 2022.

Cybin said that it’s moving through its phase 1/2a clinical trial looking at CYB003, its deuterated psilocybin molecule used as a way to treat major depressive disorder. Deuterated versions of drugs are easier for the body to metabolize.

The company also recently received approval from an independent ethics committee in the Netherlands to start dosing humans with its CYB004, a proprietary deuterated DMT analog.

“This marks the first time a deuterated DMT molecule will be evaluated in humans and reduces Cybin’s time-to-clinic with CYB004,” the company said, adding that it plans to apply initial findings in the trial to improve dose delivery in future clinical trials.

Cybin had C$22.5 million worth of cash at the end of the quarter and C$20 million as of the Feb. 14 filing. Net loss totaled C$10.7 million versus to a net loss of C$17.2 million in the same period last year.

“Looking ahead, we remain well-positioned to deliver on multiple near-term clinical milestones and data catalysts across our pipeline programs. With interim data expected imminently for our Phase 1/2a study of CYB003 and approval to begin dosing CYB004 in humans, the stage is set for continued momentum and strong clinical execution,” CEO Doug Drysdale said.

CYB003’s therapeutic profile as a potentially differentiated treatment for major depressive disorder is expected to provide more consistent and predictable dosing, and low intra- and inter-individual variability, “with the goal of reducing time and resource burden on the health care system.”

The drug is designed to potentially address the challenges and limitations of oral psilocybin, and according to preclinical data, the company said that it achieved low variability in plasma levels, fast onset of action, and a short duration of effect.

For the DMT study, Cybin said that it would target anxiety disorder, with or without major depressive disorder, as CYB004’s target indication.

Cybin said that preclinical data shows the DMT molecule administered using an IV is more effective and is metabolized more easily versus inhalation.

“These studies also demonstrated that IV CYB004 has a longer duration of effect compared to DMT, indicating the potential to extend the therapeutic window and provide better dose optimization,” the company said. “These factors may support more convenient dosing methods such as subcutaneous, inhaled, or intramuscular administration.”

Cybin secured a U.S. composition of matter patent covering CYB004 in February 2022 that provides patent protection through 2041. The patent covers a range of deuterated forms of DMT and protects CYB004 as a putative new chemical entity.

Cash-based operating expenses were C$11.1 million versus C$12.0 million in the same period last year. Cash flows used in operating activities were C$10.8 million versus C$12.8 million the same time the previous year.

“With a cash runway that will support upcoming value-driving clinical milestones, we will continue our focus on clinical execution with the goal of ultimately bringing improved therapeutic options to patients in need,” Drysdale said.

An at-the-market $35 million equity program allows Cybin to issue and sell up to an additional $26 (C$35) million worth of shares.

“Depending on market conditions, this will provide Cybin with access to additional cash for growth opportunities and working capital,” the company said.

The company plans to provide an update on the CYB004-E trial and the CYB004 program at its virtual R&D Day on Feb. 28.

Adam Jackson

Adam Jackson writes about the cannabis industry for the Green Market Report. He previously covered the Missouri Statehouse for the Columbia Missourian and has written for the Missouri Independent. He most recently covered retail, restaurants and other consumer companies for Bloomberg Business News. You can find him on Twitter at @adam_sjackson and email him at

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