Cybin Inc. Reports First Quarter Financial Results and Recent Business Highlights

“Looking back at the last 12 months, we have made positive progress toward our goal of advancing psychedelics to therapeutics. In that time, we have moved from the lab to the clinic where we now have two major development programs underway,” said Doug Drysdale, Chief Executive Officer of Cybin.” “Our lead candidate CYB003 is the first novel psilocybin analog to be evaluated in a Phase 1/2a trial for the treatment of major depressive disorder. Enrollment has commenced and interim pharmacokinetic and safety data is expected at the end of the year.⁽¹⁾ Our Phase 1 CYB004-E study to evaluate the safety, pharmacokinetics and pharmacodynamics of a target-controlled intravenous infusion of DMT in healthy tobacco smokers is also underway. This is the largest Phase 1 DMT study to date and has the potential to yield important information as we look to potentially create improved treatment options for anxiety disorders”.

Doug Drysdale, Chief Executive Officer of Cybin.

• Initiated enrollment for its first-in-human Phase 1/2a trial of CYB003 in major depressive disorder (“MDD”). The Company announced that it received a “may proceed letter” and Investigational New Drug Application clearance from the U.S. Food and Drug Administration (the “FDA“) for its Phase 1/2a study in June 2022. The Phase 1/2a trial is a randomized, double-blind, placebo-controlled study evaluating up to two doses of CYB003 in approximately 32 patients with moderate to severe MDD. The Company has partnered with Clinilabs Drug Development Corporation, a full-service contract research organization with expertise in central nervous system drug development, to conduct this Phase 1/2a trial. CYB003 is designed to potentially address the challenges and limitations of oral psilocybin. Based on preclinical data, CYB003 achieved less variability in plasma levels, faster onset of action, and shorter duration of effect.
• Completed the acquisition of a Phase 1 DMT study from Entheon Biomedical Corp. The CYB004-E study, which is ongoing at the Centre for Human Drug Research in the Netherlands, is the largest Phase 1 DMT study conducted to date. The study is assessing the pharmacokinetics and pharmacodynamics of intravenous DMT in 50 healthy tobacco smokers, and is anticipated to provide safety and dosing data to inform the clinical development plan for CYB004. In preclinical studies, CYB004 demonstrated key advantages over intravenous and inhaled DMT, including longer duration and rapid onset of effect, improved bioavailability, and low variability.
• Continued to build the Company’s intellectual property portfolio, with 1 patent issued and 19 patents pending across six patent families. The Company’s IP portfolio includes a United States Patent and Trademark Office patent covering certain deuterated forms of DMT and 5-MeO-DMT. This patent protects CYB004 as a putative new chemical entity. In addition, an international patent application was published by the World Intellectual Property Organization covering inhalation delivery methods for multiple psychedelic molecules.
• Completed more than 200 preclinical studies to date, supporting the Company’s growing portfolio of proprietary psychedelic molecules. This highlights Cybin’s dedication to researching and developing potential psychedelic treatments for patients in need. To date, the Company has developed over 50 novel compounds, and continues to advance preclinical work on its proprietary molecules being developed for the potential treatment of various mental health conditions.

• The Company plans to report interim safety and PK data from the Phase 1/2a study at the end of calendar year 2022.⁽¹⁾

• The CYB004-E Phase 1 study is currently underway, and is evaluating DMT in 50 healthy volunteers who smoke tobacco. The Company expects the last subject visit by November, and to complete the Phase 1 study in the first quarter of calendar 2023.⁽¹⁾

• The Company expects to report preclinical data for CYB005 in the second half of calendar year 2022, at which time the Company expects to nominate a candidate and complete its assessment of the potential path forward for this candidate, including whether to develop internally or by way of a potential third party partnership.⁽²⁾

• Cybin and its partner Kernel expect to report data from a Phase 1 feasibility study evaluating brain activity following ketamine administration and the participant’s experience wearing the Flow headset in the fourth quarter of calendar year 2022. Results from the study will determine the next steps forward for this important program.⁽³⁾

• Cash and cash equivalents totaled to C$42.5 million as of June 30, 2022.
• Cash-based operating expenses totaled C$11.2 million for the quarter ended June 30, 2022, of which C$1.1 million were one-time, non-recurring costs. Non-cash expenses totaled C$1.9 million for a net loss of C$13.1 million.
• Cash flows used in operating activities were C$11.1 million for the quarter ended June 30, 2022 of which C$1.1 million were one-time, non-recurring costs.