Cybin Announces Roster of 28 Expert Faculty and Advisors for its EMBARK Psychedelic Facilitator Training Program

 
Cybin-Inc.

— CYB003 is the first psilocybin analog to be evaluated in Phase 1/2a development for the treatment of major depressive disorder —

May 31, 2022 08:00 AM Eastern Daylight Time

TORONTO — Cybin Inc. (NEO:CYBN)(NYSE:CYBN)(Cybin or the Company), a biopharmaceutical company focused on progressing “Psychedelics to TherapeuticsTM”, is pleased to announce the submission of an Investigational New Drug (“IND”) application to the U.S. Food and Drug Administration (“FDA”) for its Phase 1/2a first-in-human clinical trial evaluating CYB003, a proprietary deuterated psilocybin analog, for the treatment of major depressive disorder (“MDD”).

“Following the successful completion of our IND-enabling work just last month, we are very excited to have reached this major milestone toward advancing CYB003 into clinical development so quickly. Based on preclinical studies, our proprietary psilocybin analog has the potential to offer numerous advantages over classic psilocybin with the potential to ultimately provide better outcomes for people suffering with MDD,” said Doug Drysdale, Chief Executive Officer of Cybin Inc. (NEO:CYBN)(NYSE:CYBN). “This FDA submission is the next major step in the advancement of CYB003, and we continue to work tirelessly to bring this innovative therapeutic option to people as quickly as possible. We look forward to continuing to work with the FDA to initiate the Phase 1/2a trial in mid-2022.”

About the CYB003 Phase 1/2a Trial

The Phase 1/2a trial is a randomized, double blind, placebo-controlled study evaluating people with moderate to severe MDD. Subjects will receive two administrations (placebo/active and active/active) and a response/remission will be assessed at Week 3 (after single dose) and at Week 6 (after receiving a second dose). Using the Montgomery-Asberg Depression Rating Scale, the trial will assess rapid onset of antidepressant effect on the day of dosing. The study will also evaluate the benefit of more than one administration and will provide pharmacokinetic (“PK”) and safety data. The trial design will allow for people to continue their treatment with selective serotonin reuptake inhibitors (“SSRIs”). An optional open-label follow-up study (up to 12 weeks) will allow an assessment of durability of treatment effects.

“Through this Phase 1/2a trial, we are primarily looking to demonstrate the improved PK and safety profile of CYB003, as well as efficacy. We have designed the trial to allow people to continue to take their antidepressant medication, which will also allow us to assess the effect of CYB003 on people who are treated with an SSRI. At this time, we expect to have a PK and safety data readout by the end of 2022,” concluded Drysdale.

Cybin Inc. (NEO:CYBN)(NYSE:CYBN) has engaged Clinilabs Drug Development Corporation, a global, full-service contract research organization with deep expertise in central nervous system drug development, to carry out the Phase 1/2a clinical trial of CYB003.

The detailed Phase 1/2a study protocol is available at clinicaltrials.gov under the Identifier number: NCT05385783.

About CYB003

CYB003 is derived from psilocybin, which is part of a family of molecules called indolamines that include more common neurotransmitters, such as serotonin. Psilocybin is dephosphorylated to form its metabolite, psilocin, which can cross the blood-brain-barrier. Given its structural similarity to serotonin, psilocin can easily activate the serotonin 5-HT2A receptor. CYB003 is a deuterated psilocybin analog designed to achieve less variability in plasma levels, faster onset of action, shorter duration of effect and potentially better tolerability. CYB003 has the potential to effectively treat MDD and alcohol use disorder.

About Cybin

Cybin Inc. (NEO:CYBN)(NYSE:CYBN) 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 Inc. (NEO:CYBN)(NYSE:CYBN) is operational in Canada, the United States, United Kingdom 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.

Cautionary Notes and Forward-Looking Statements

Certain statements in this press release constitute forward-looking information. All statements other than statements of historical fact contained in this press release, including, without limitation, statements regarding Cybin Inc.’s (NEO:CYBN)(NYSE:CYBN) future, strategy, plans, objectives, goals and targets, and any statements preceded by, followed by or that include the words “believe”, “expect”, “aim”, “intend”, “plan”, “continue”, “will”, “may”, “would”, “anticipate”, “estimate”, “forecast”, “predict”, “project”, “seek”, “should” or similar expressions or the negative thereof, are forward-looking statements. Forward-looking statements in this news release include statements regarding the Company’s proprietary drug discovery platforms, innovative drug delivery systems, novel formulation approaches and treatment regimens to potentially treat psychiatric disorders.

These forward-looking statements are based on reasonable assumptions and estimates of management of the Company at the time such statements were made. Actual future results may differ materially as forward-looking statements involve known and unknown risks, uncertainties, and other factors which may cause the actual results, performance, or achievements of Cybin Inc. (NEO:CYBN)(NYSE:CYBN) to materially differ from any future results, performance, or achievements expressed or implied by such forward-looking statements. Such factors, among other things, include: implications of the COVID-19 pandemic on the Company’s operations; fluctuations in general macroeconomic conditions; fluctuations in securities markets; expectations regarding the size of the psychedelics market; the ability of the Company to successfully achieve its business objectives; plans for growth; political, social and environmental uncertainties; employee relations; the presence of laws and regulations that may impose restrictions in the markets where the Company operates; and the risk factors set out in the Company’s management’s discussion and analysis for the period ended December 31, 2021 and the Company’s listing statement dated November 9, 2020, which are available under the Company’s profile on www.sedar.com and with the U.S. Securities and Exchange Commission on EDGAR at www.sec.gov. Although the forward-looking statements contained in this news release are based upon what management of the Company believes, or believed at the time, to be reasonable assumptions, the Company cannot assure shareholders that actual results will be consistent with such forward-looking statements, as there may be other factors that cause results not to be as anticipated, estimated or intended. Readers should not place undue reliance on the forward-looking statements and information contained in this news release. The Company assumes no obligation to update the forward-looking statements of beliefs, opinions, projections, or other factors, should they change, except as required by law.

Cybin Inc. (NEO:CYBN)(NYSE:CYBN) makes no medical, treatment or health benefit claims about Cybin Inc.’s (NEO:CYBN)(NYSE:CYBN) proposed products. The U.S. Food and Drug Administration, Health Canada or other similar regulatory authorities have not evaluated claims regarding psilocybin, psychedelic tryptamine, tryptamine derivatives or other psychedelic compounds. The efficacy of such products has not been confirmed by approved research. There is no assurance that the use of psilocybin, psychedelic tryptamine, tryptamine derivatives or other psychedelic compounds can diagnose, treat, cure or prevent any disease or condition. Rigorous scientific research and clinical trials are needed. Cybin Inc. (NEO:CYBN)(NYSE:CYBN) has not conducted clinical trials for the use of its proposed products. Any references to quality, consistency, efficacy and safety of potential products do not imply that Cybin Inc. (NEO:CYBN)(NYSE:CYBN) verified such in clinical trials or that Cybin Inc. (NEO:CYBN)(NYSE:CYBN) will complete such trials. If Cybin Inc. (NEO:CYBN)(NYSE:CYBN) cannot obtain the approvals or research necessary to commercialize its business, it may have a material adverse effect on Cybin’s performance and operations.

Neither the NEO Exchange Inc. nor the NYSE American LLC stock exchange have approved or disapproved the contents of this news release and are not responsible for the adequacy and accuracy of the contents herein.

SOURCE Cybin Inc. (NEO:CYBN)(NYSE:CYBN)

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6) This document contains forward-looking information and forward-looking statements, within the meaning of applicable Canadian securities legislation, (collectively, “forward-looking statements”), which reflect management's expectations regarding Cybin Inc.’s future growth, future business plans and opportunities, expected activities, and other statements about future events, results or performance. Wherever possible, words such as “predicts”, “projects”, “targets”, “plans”, “expects”, “does not expect”, “budget”, “scheduled”, “estimates”, “forecasts”, “anticipate” or “does not anticipate”, “believe”, “intend” and similar expressions or statements that certain actions, events or results “may”, “could”, “would”, “might” or “will” be taken, occur or be achieved, or the negative or grammatical variation thereof or other variations thereof, or comparable terminology have been used to identify forward-looking statements. These forward-looking statements include, among other things, statements relating to: (a) revenue generating potential with respect to Cybin Inc.’s industry; (b) market opportunity; (c) Cybin Inc.’s business plans and strategies; (d) services that Cybin Inc. intends to offer; (e) Cybin Inc.’s milestone projections and targets; (f) Cybin Inc.’s expectations regarding receipt of approval for regulatory applications; (g) Cybin Inc.’s intentions to expand into other jurisdictions including the timeline expectations relating to those expansion plans; and (h) Cybin Inc.’s expectations with regarding its ability to deliver shareholder value. Forward-looking statements are not a guarantee of future performance and are based upon a number of estimates and assumptions of management in light of management’s experience and perception of trends, current conditions and expected developments, as well as other factors that management believes to be relevant and reasonable in the circumstances, as of the date of this document including, without limitation, assumptions about: (a) the ability to raise any necessary additional capital on reasonable terms to execute Cybin Inc.’s business plan; (b) that general business and economic conditions will not change in a material adverse manner; (c) Cybin Inc.’s ability to procure equipment and operating supplies in sufficient quantities and on a timely basis; (d) Cybin Inc.’s ability to enter into contractual arrangements with additional Pharmacies; (e) the accuracy of budgeted costs and expenditures; (f) Cybin Inc.’s ability to attract and retain skilled personnel; (g) political and regulatory stability; (h) the receipt of governmental, regulatory and third-party approvals, licenses and permits on favorable terms; (i) changes in applicable legislation; (j) stability in financial and capital markets; and (k) expectations regarding the level of disruption to as a result of CV-19. Such forward-looking information involves a variety of known and unknown risks, uncertainties and other factors which may cause the actual plans, intentions, activities, results, performance or achievements of Cybin Inc. to be materially different from any future plans, intentions, activities, results, performance or achievements expressed or implied by such forward-looking statements. Such risks include, without limitation: (a) Cybin Inc.’s operations could be adversely affected by possible future government legislation, policies and controls or by changes in applicable laws and regulations; (b) public health crises such as CV-19 may adversely impact Cybin Inc.’s business; (c) the volatility of global capital markets; (d) political instability and changes to the regulations governing Cybin Inc.’s business operations (e) Cybin Inc. may be unable to implement its growth strategy; and (f) increased competition.

Except as required by law, Cybin Inc. undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, future event or otherwise, after the date on which the statements are made or to reflect the occurrence of unanticipated events. Neither does Cybin Inc. nor any of its representatives make any representation or warranty, express or implied, as to the accuracy, sufficiency or completeness of the information in this document. Neither Cybin Inc. nor any of its representatives shall have any liability whatsoever, under contract, tort, trust or otherwise, to you or any person resulting from the use of the information in this document by you or any of your representatives or for omissions from the information in this document.

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