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

“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. 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.”

Doug Drysdale, Chief Executive Officer of Cybin

• The Company recently received approval from an independent ethics committee in the Netherlands to commence first-in-human dosing of CYB004 through a protocol amendment to its ongoing Phase 1 CYB004-E trial (“ CYB004-E trial ”). 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 plans to apply these initial findings in the CYB004-E trial to optimize dose delivery in future clinical trials.
• On January 12, 2023, Cybin announced that it selected generalized anxiety disorder (“ GAD ”), with or without major depressive disorder (“ MDD ”) as the target indication for CYB004.
• Based on preclinical data, CYB004 has demonstrated an improved bioavailability and pharmacokinetic (“PK” ) profile in comparison to DMT when administered via intravenous (“ IV ”) and inhaled routes. 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. 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.
• The Company plans to provide an update on the CYB004-E trial and the CYB004 program at its virtual R&D Day on February 28, 2023 ⁱ .

• Cybin continues to progress its Phase 1/2a clinical trial evaluating CYB003 for the potential treatment of MDD. The Company plans to provide an interim readout from the Phase 1/2a trial at its virtual R&D Day on February 28, 2023 ⁱ . The interim readout is intended to provide an initial understanding of the safety and PK profile of CYB003 in humans, including preliminary observations related to the psychedelic effect and duration of psychedelic effect of CYB003. These findings will help provide the necessary dose ranging information for the ongoing Phase 1/2a trial in addition to future clinical studies evaluating CYB003.
• CYB003 is designed to potentially address the challenges and limitations of oral psilocybin. Based on preclinical data, CYB003 achieved low variability in plasma levels, fast onset of action, and a short duration of effect. CYB003’s therapeutic profile as a potentially differentiated treatment for MDD 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 healthcare system.
• CYB003 is the first ever deuterated psilocybin analog to enter clinical development and its therapeutic profile as a potentially differentiated treatment for MDD has recently been highlighted in poster presentations at multiple scientific conferences.

• On January 18, 2023, the Company announced promising results from its sponsored feasibility study, conducted by HI, LLC dba Kernel (“ Kernel ”), that provided key proof-of-principle for Kernel Flow wearable technology (“ Flow ”) as a portable functional system that provides real-time measurements of blood oxygenation changes in the brain associated with neural activity during the administration of psychedelics. These findings support Flow as a tool to potentially provide valuable insight into the effects and mechanisms of psychedelics on the brain. Further analysis from this study is ongoing and will inform Cybin’s potential integration of Flow in future clinical trials.

• The virtual R&D Day event will be hosted by Cybin’s leadership team and will feature key opinion leader Dr. Maurizio Fava, Psychiatrist-in-Chief of Massachusetts General Hospital (“ MGH ”), Vice Chair of the MGH Executive Committee on Research, Executive Director of the Clinical Trials Network and Institute at MGH, Associate Dean for clinical and translational research, and the Slater Family Professor of Psychiatry at Harvard Medical School.
• During the event, the Company expects to provide an interim readout from the ongoing Phase 1/2a trial evaluating CYB003 for the potential treatment of MDD, an update from the ongoing Phase 1 CYB004-E trial evaluating IV DMT and an update on its CYB004 program for the potential treatment of GAD. Click here to register for the event.

• Cash totaled C$22.5 million as of December 31, 2022, and C$20 million as of February 14, 2023.
• Net loss was C$10.7 million for the quarter ended December 31, 2022, compared to a net loss of C$17.2 million in the same period last year.
• Cash-based operating expenses totaled C$11.1 million compared to C$12.0 million in the same period last year.
• Cash flows used in operating activities were C$10.8 million for the quarter ended December 31, 2022, compared to C$12.8 million in the same period last year.
• Pursuant to the previously announced at-the-market (“ ATM ”) US$35 million equity program, as of February 14, 2023, the ATM allows Cybin to issue and sell up to an additional US$26 (C$35) million of common shares. Depending on market conditions, this will provide Cybin with access to additional cash for growth opportunities and working capital.