Mr. Doug Drysdale reports

CYBIN INC. REPORTS FIRST QUARTER FINANCIAL RESULTS AND RECENT BUSINESS HIGHLIGHTS

Cybin Inc. has released its unaudited financial results for the first quarter ended June 30, 2022, 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 under way," 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. Enrolment 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 under way. 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," continued Mr. Drysdale.

Recent business and pipeline highlights:

• Initiated enrolment 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 (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 Corp., 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 continuing 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 (IP) portfolio, with one 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.

Upcoming pipeline and strategic milestones

CYB003: deuterated psilocybin analog for the potential treatment of MDD and AUD:

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

CYB004: deuterated DMT for the potential treatment of anxiety disorders:

• The CYB004-E phase 1 study is currently under way 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).

CYB005: phenethylamine derivative for the potential treatment of neuroinflammation:

• 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).

Kernel Flow:

• 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).

"Our commitment to finding safe and more effective treatments across the spectrum of mental health conditions has never been greater. Looking ahead, we are especially encouraged by the support that the healing potential of psychedelics continues to receive by many governmental and mainstream organizations. This is an exciting time for Cybin and for the industry as a whole as we move even closer to bringing potential psychedelic therapies to people in need," concluded Mr. Drysdale.

First quarter financial highlights:

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

About Cybin Inc.

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.

(1) There is no assurance that these timelines will be met. Anticipated timelines regarding drug development are based on reasonable assumptions informed by current knowledge and information available to the company.

(2) Anticipated timelines and spending regarding drug development are based on reasonable assumptions informed by current knowledge and information available to the company. Such statements are informed by, among other things, regulatory guidelines for developing a drug with safety studies, proof-of-concept studies, and pivotal studies for new drug application submission and approval, and assumes the success of implementation and results of such studies on timelines indicated as possible by such guidelines, other industry examples and the company's development efforts to date. This statement is based on the following material factors and assumptions. The company assumes it will enter into a contract with a licensed third party vendor to undertake extensive preclinical characterization of target molecules on the company's behalf. The company anticipates to complete a number of animal models and the completion of absorption, distribution, metabolism and excretion profiles. The company assumes to enter into third party agreements in order to complete a range of additional preclinical programs, including, but not limited to, dose-ranging studies in multiple animal species, toxicity studies in multiple animal species, genotoxicity studies, teratogenicity studies, along with neuropharmacological, pulmonary and cardiovascular profiling, before the final selection of drug candidates for entry into human trials. As of the date hereof, it has not yet completed the aforementioned items. Such statements are informed by, among other things, regulatory guidelines for developing a drug with safety studies, proof-of-concept studies, and pivotal studies for new drug application submission and approval, and assumes the success of implementation and results of such studies on timelines indicated as possible by such guidelines, other industry examples and the company's development efforts to date.

(3) There is no assurance that these timelines will be met. Anticipated timelines regarding sponsorships are based on reasonable assumptions informed by current knowledge and information available to the company from sponsorship partners.

We seek Safe Harbor.