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

Cybin Inc. (NEO:CYBN) (NYSE American:CYBN), a biopharmaceutical company focused on progressing Psychedelics to Therapeutics®, today reported unaudited…



Cybin Inc. (NEO:CYBN) (NYSE American:CYBN), a biopharmaceutical company focused on progressing Psychedelics to Therapeutics®, today reported unaudited financial results for its second quarter ended September 30, 2022, and recent business highlights.

“We have continued to make progress as planned, advancing our clinical pipeline of modified psychedelic-based molecules while also strengthening our drug discovery platform of differentiated preclinical compounds,”

Doug Drysdale, Chief Executive Officer of Cybin

“In addition to our clinical work, we have been actively broadening our robust IP portfolio through securing strategic licensing agreements for preclinical psychedelic-based compounds that will support our ongoing drug development efforts. These recent initiatives will also pave the way for Cybin to continue to pursue the potential creation of safe and effective therapeutics for patients facing the challenges of mental health conditions,” continued Drysdale.

Second-Quarter Financial Information:

  • Cash totaled C$29.9 million as of September 30, 2022, and C$27.1 million as of November 14, 2022.
  • Net loss was C$10.0 million for the quarter ended September 30, 2022.
  • Cash-based operating expenses totaled C$11.3 million of which C$2.0 million were one-time costs.
  • Cash flows used in operating activities were C$14.7 million for the quarter ended September 30, 2022 of which C$2.5 million were one-time, non-recurring costs and C$2.4 million were recorded to prepaid expenses related to future clinical work.
  • Pursuant to the previously announced at-the-market (“ATM”) US$35 million equity program, as of November 14, 2022, the ATM allows Cybin to issue and sell up to an additional US$28.9 (C$38.4) million of common shares. Depending on market conditions, this will allow Cybin to access additional cash for growth opportunities and working capital.

Recent Business and Pipeline Highlights:

  • Reported progress update on CYB004-E Phase 1 trial. The CYB004-E trial evaluating N,N-dimethyltryptamine (“DMT”) completed dosing for four out of five participant cohorts with no clinically significant safety or tolerability issues. The study is assessing the pharmacokinetics (“PK”) and pharmacodynamics (“PD”) of DMT and is anticipated to provide safety and dosing data to inform the future development of CYB004, the Company’s proprietary DMT molecule for the potential treatment of anxiety disorders.
  • Strengthened drug discovery platform and intellectual property (“IP”) portfolio through multiple licensing arrangements. These licensing arrangements, which include a catalog of tryptamine-based molecules acquired from Mindset Pharma Inc., complement Cybin’s existing preclinical library, broaden the Company’s IP reach and create a path for potential future pipeline expansion. These arrangements also provide the Company with additional access to IP from more than 15 patents or patent applications. Collectively, Cybin now has access to more than 35 patents and applications through a combination of internal filings and licensing arrangements.
  • Commenced dosing in Phase 1/2a trial of CYB003 for the treatment of major depressive disorder (“MDD”). CYB003 is the Company’s first novel psilocybin analog to enter clinical development. The Phase 1/2a trial is a randomized, double-blind, placebo-controlled study evaluating the safety, tolerability, PK and PD of up to two doses of CYB003 in approximately 32 patients with moderate to severe MDD. In preclinical studies, CYB003 demonstrated faster onset and shorter duration of effect, less variability in plasma levels, and improved brain penetration when compared to oral psilocybin, suggesting that CYB003 has the potential to address therapeutic limitations associated with oral psilocybin.
  • Established an ATM equity program allowing the Company to issue and sell up to USD$35 million of common shares in the capital of the Company. Cybin intends to use the net proceeds from the sale of shares under the ATM program for growth opportunities and working capital initiatives.

Upcoming Pipeline and Strategic Milestones:

  • CYB003: Deuterated psilocybin analog for the potential treatment of MDD
    The Company plans to provide an interim safety and PK readout from the Phase 1/2a study in early 2023.i
  • CYB004: Deuterated DMT for the potential treatment of anxiety disorders
    The CYB004-E Phase 1 study is currently underway and is evaluating DMT, in healthy volunteers. The Company expects to complete the Phase 1 study in early calendar 2023i.
  • CYB005: Phenethylamine derivative for the potential treatment of neuroinflammation
    The Company expects to provide an update on its CYB005 program in the coming months, at which time the Company will complete its assessment of the potential path forward for this candidate, including whether to develop internally or by way of a third-party partnership.ii
  • Kernel Flow®
    Cybin and its partner HI, LLC dba Kernel (“Kernel”), expect to report data from a Phase 1 feasibility study evaluating Kernel’s Flow® technology to measure ketamine’s psychedelic effect on cerebral cortex hemodynamics at the end of 2022. Results from the study will inform the next steps forward for this important program.iii

“Our commitment to discovering and developing innovative psychedelic-based treatment options for areas of high unmet need is unwavering. We are focused on strengthening our position as an innovator in the industry and thereby differentiating ourselves in the psychedelics space to deliver long-term value to all our stakeholders,” concluded Drysdale.

About Cybin

Cybin is a leading ethical biopharmaceutical company, working with a network of world-class partners and internationally recognized scientists, on a mission to create safe and effective therapeutics for patients to address a multitude of mental health issues. Headquartered in Canada and founded in 2019, Cybin is operational in Canada, the United States, the United Kingdom, the Netherlands and Ireland. The Company is focused on progressing Psychedelics to Therapeutics by engineering proprietary drug discovery platforms, innovative drug delivery systems, novel formulation approaches and treatment regimens for mental health disorders.

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