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

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

06/03/2022

TORONTO–(BUSINESS WIRE)– Cybin Inc. (NEO:CYBN) (NYSE American:CYBN) (“Cybin” or the “Company”), a biopharmaceutical company focused on progressing “Psychedelics to Therapeutics™”, today announced the team of 28 esteemed faculty and advisors who will lead the Company’s EMBARK Psychedelic Facilitator Training Program. Recognizing the crucial importance of supporting psychedelic study facilitators with quality training, Cybin has brought together recognized leaders and senior psychedelic-assisted psychotherapy trainers from leading universities and psychedelic research and training organizations.

“For EMBARK, we have set out to build an extraordinary training program in psychedelic-assisted psychotherapy. We don’t think a single person holds all the answers. Instead, we have gathered together the wisdom of 28 of the world’s leading experts in psychedelic practice as teachers, supervisors, and advisors for our program. They are the recognized leaders in their fields, and I’m deeply grateful for their skill, integrity, and heartfelt teachings,” said Dr. Alex Belser, Chief Clinical Officer at Cybin.

EMBARK is a leading-edge model of psychedelic-assisted psychotherapy co-developed by Alex Belser, PhD, and Bill Brennan, PhD. EMBARK provides six clinical domains (Existential-Spiritual, Mindfulness, Body Aware, Affective-Cognitive, Relational, and Keeping Momentum). Additionally, EMBARK is built upon four care cornerstones: trauma-informed care, culturally-informed care, ethically rigorous care, and collective care.

“Because of the multi-dimensional, profound content of psychedelic-assisted psychotherapy sessions, a training to prepare therapists to do this work requires more ethical education than what is offered by the traditional, stand-alone ethics lecture. Cybin’s EMBARK accepted that challenge and created a program in which ethical inquiry undergirds all of its programming,” said Kylea Taylor, LMFT, author of The Ethics of Caring and creator of InnerEthics®.

EMBARK faculty members include:

  • Anthony Back, MD, Professor of Medicine at the University of Washington in Seattle, and the Fred Hutchinson Cancer Research Center. He is the Principal Investigator for a Phase 2 clinical trial to treat frontline clinicians experiencing COVID-related burnout and distress.
  • Alex Belser, PhD, co-creator of EMBARK, Chief Clinical Officer at Cybin, Chair of Cybin’s Clinical Advisory Board, and Co-Investigator on a psilocybin clinical trial at Yale University.
  • Bill Brennan, PhD, co-creator of EMBARK and author researching best practices for psychedelic psychotherapy.
  • NiCole T. Buchanan, PhD, Clinical-Community Psychologist, Professor, and Justice, Equity, Diversity, and Inclusion (JEDI) consultant.
  • Stacia Butterfield, certified Holotropic Breathwork practitioner and a teacher with Grof Transpersonal Training.
  • Jeffrey Guss, MD, psychiatrist, psychoanalyst, researcher and teacher specializing in psychoanalytic therapy and psychedelic therapy. He is a Lead Trainer at Fluence and Clinical Assistant Professor of Psychiatry at the NYU School of Medicine.
  • Amir Inamdar, MBBS, DNB (Psych), MFPM, psychiatrist, pharmaceutical physician, drug developer and Cybin’s Chief Medical Officer.
  • Alex Kelman, PhD, Senior Director for the EMBARK Training Program and Attending Psychologist and Assistant Clinical Professor at the University of California, Los Angeles.
  • Adele Lafrance, PhD, developer of emotion-focused treatment modalities, and Strategic Lead and Clinical Investigator for MDMA-Assisted Therapy Research
  • Manuela Mischke-Reeds, MA, MFT, somatic psychotherapist and teacher, co-director of the Hakomi Institute of California, Chief Mental Health Officer at Abroad.
  • Marcela Ot’alora, G, MA, LPC, trainer, researcher and advocate for the safe and ethical use of psychedelic therapy. She is a lead trainer for the MAPS MDMA Therapy Training Program.
  • Florie St. Aime, LCSW, invites others into liberation practices through social justice organizing, group facilitation, individual psychotherapy, supervision and holding sacred space.
  • Kylea Taylor, MFT, created and teaches InnerEthics®, a self-reflective approach to ethics education that she first described in her book The Ethics of Caring.

Advisors, Clinical Supervisors, and Subject Matter Experts include:

  • Melissa Field, Senior Manager of Clinical Process and Training at Cybin.
  • Ingmar Gorman, PhD, CEO and Co-Founder of Fluence, a clinical psychologist, and former site Co-Principal Investigator and therapist for MAPS MDMA-assisted psychotherapy trials.
  • Charlotte Harrison, clinical trial consultant collaborating with the Cybin team on protocol and training development. She has worked in clinical research for over a decade, including overseeing MAPS’ MDMA-assisted psychotherapy program.
  • Diane Hollman, Senior Director of Clinical Alliances at Cybin.
  • Franklin King, MD, Instructor at Harvard Medical School and psychiatrist at Massachusetts General Hospital where he serves as the Director of Training and Education at the Center for Neuroscience of Psychedelics.
  • Robert Krause, DNP APRN-BC, Co-director of Centered PLLC, researcher, therapist, and educator. He has lectured at Yale University and is visiting faculty in the Consciousness Studies Department at the Graduate Institute. A graduate of CIIS’s founding cohort in Psychedelic Assisted Therapy, he is also a MAPS therapist in an expanded access protocol.
  • John Krystal, MD, Chair at Yale University’s Department of Psychiatry and Co-Director of Yale’s Center for Clinical Investigation.
  • Dennis McKenna, PhD, author or co-author of three books and over 50 peer-reviewed papers on the chemistry, ethnopharmacology, and neuroscience of psychedelics, as well as other botanical medicines. He is a founding board member of Heffter Research Institute, and the founder and President of the McKenna Academy of Natural Philosophy, which is focused on psychedelic education and the preservation of traditional knowledge, facilitating its integration with scientific knowledge.
  • Elizabeth Nielson, PhD, CVO and Co-Founder of Fluence, a site Co-Principal Investigator and therapist for MAPS MDMA-assisted psychotherapy trials, and an investigator in NYU’s study of psilocybin-assisted psychotherapy for Alcohol Use Disorder.
  • Sarah Scheld, MA, EMBARK Training Program Consultant.
  • Jordan Sloshower, MD, MSc, psychiatrist and researcher at Yale University where he serves as an investigator and therapist in several clinical trials of psilocybin-assisted therapy. Jordan is also a clinical investigator in MAPS’ Expanded Access Program for MDMA-assisted therapy of PTSD and serves as a lead trainer with Usona Institute’s psilocybin facilitator training program.
  • Andrew Solomon, PhD, professor of clinical psychology at Columbia and a lecturer in psychiatry at Yale, is the National Book Award-winning author of The Noonday Demon and Far from the Tree, a writer for The New Yorker, and a writer and speaker on politics, psychology, and the arts.

Cybin’s Clinical Advisory Board includes:

  • Anthony Back, MD, Professor of Medicine at the University of Washington School of Medicine in Seattle and the Fred Hutchinson Cancer Research Center. He is the Principal Investigator for a Phase 2 clinical trial to treat frontline clinicians experiencing COVID-related burnout and distress.
  • Alex Belser, PhD, Chief Clinical Officer at Cybin and Chair of Cybin’s Clinical Advisory Board.
  • Maurizio Fava, MD, Psychiatrist-in-Chief in the Department of Psychiatry at Massachusetts General Hospital, and an Associate Dean for Clinical and Translational Research at Harvard Medical School.
  • Tom Laughren, MD, Director at Laughren Psychopharm Consulting, LLC, and the Former Director of FDA’s Division of Psychiatry Products.
  • Lynn Marie Morski, MD, JD, President of the Psychedelic Medicine Association.

Cybin launched the EMBARK Psychedelic Facilitator Training Program for study facilitators in October 2021. The program offers psychedelic clinical trial facilitators the foundational training needed to provide skillful and ethical care to treat participants receiving psychedelic-assisted therapy. The curriculum prepares facilitators to work with a range of experiences that may arise for participants in each domain, and to ground their work in each care cornerstone.

For more information on the EMBARK program, please click here.

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 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’s 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 the Company 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 makes no medical, treatment or health benefit claims about Cybin’s 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 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 verified such in clinical trials or that Cybin will complete such trials. If Cybin 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.

Investors & Media:
Leah Gibson
Vice President, Investor Relations & Strategic Communications
Cybin Inc.
irteam@cybin.com – or – media@cybin.comSource: Cybin Inc.

Cybin to Host Key Opinion Leader Webinar on June 9, 2022

Cybin to Host Key Opinion Leader Webinar on June 9, 2022

06/02/2022

– Featured speakers include Dr. John Krystal, Yale School of Medicine, and Dr. David Nutt, Imperial College London –

– Deep dive into the psychedelics landscape and overview of current and emerging psychedelic-based treatments –

TORONTO–(BUSINESS WIRE)– Cybin Inc. (NEO:CYBN) (NYSE American:CYBN) (“Cybin” or the “Company”), a biopharmaceutical company focused on progressing “Psychedelics to Therapeutics™,” today announced that it will host a virtual Key Opinion Leader webinar on Thursday June 9, 2022, from 11:00 a.m. ET to 12:00 p.m. ET. The webinar will feature two leading experts for a discussion on the psychedelics landscape and current and emerging psychedelic-based therapeutics, and will be moderated by Cybin’s Chief Executive Officer, Doug Drysdale.

To listen to the event, please click here to register and access the webcast. The archived webcast will also be available on the Company’s investor relations website on the Events & Presentations page.

Dr. John Krystal is the Robert L. McNeil, Jr., Professor of Translational Research; Professor of Psychiatry, Neuroscience, and Psychology; Chair of the Department of Psychiatry at Yale University; and Chief of Psychiatry and Behavioral Health at Yale-New Haven Hospital. Dr. Krystal has published extensively on the neurobiology and treatment of schizophrenia, alcoholism, PTSD, and depression. Notably, his laboratory discovered the rapid antidepressant effects of ketamine in patients with depression. He is the Director of the NIAAA Center for the Translational Neuroscience of Alcoholism. Dr. Krystal is a member of the U.S. National Academy of Medicine and a Fellow of the American Association for the Advancement of Science. Currently, he is co-director of the Neuroscience Forum of the U.S. National Academies of Sciences, Engineering, and Medicine; and editor of Biological Psychiatry.

Dr. David Nutt, DM, FRCP, FRCPsych, FMedSci, DLaws, is Edmund J. Safra Professor of Neuropsychopharmacology, Head Centre for Psychedelic Research in the Division of Brain Sciences, Imperial College London. He spent two years as head of the research ward at NIAAA in the USA before setting up the Psychopharmacology unit at Bristol University in 1988, where he later became Professor of Psychopharmacology and Dean of Clinical Medicine before moving to Imperial in 2008. Dr. Nutt’s contributions to pharmacology include GABA and noradrenaline receptor function in anxiety disorders, serotonin function in depression, endorphin and dopamine function in addiction and the neuroscience and clinical utility of psychedelics. He has also led psychedelic neuroimaging studies and conducted influential research on psilocybin for treatment-resistant depression. He has over 500 original research papers, a similar number of reviews/book chapters, eight government reports, and 36 books.

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 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’s 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 the Company 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 makes no medical, treatment or health benefit claims about Cybin’s 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 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 verified such in clinical trials or that Cybin will complete such trials. If Cybin 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.

Investor & Media:
Leah Gibson
Vice President, Investor Relations & Strategic Communications
Cybin Inc.
irteam@cybin.com – or – media@cybin.comSource: Cybin Inc.

Cybin Announces Publication in Frontiers in Psychology Journal Introducing EMBARK, an Integrative Model of Psychedelic Therapy

Cybin Announces Publication in Frontiers in Psychology Journal Introducing EMBARK, an Integrative Model of Psychedelic Therapy

06/02/2022

TORONTO–(BUSINESS WIRE)– Cybin Inc. (NEO:CYBN) (NYSE American:CYBN) (“Cybin” or the “Company”), a biopharmaceutical company focused on progressing “Psychedelics to Therapeutics™”, is pleased to announce the publication of a peer-reviewed article introducing EMBARK, a model of psychedelic-assisted psychotherapy that integrates leading clinical approaches to promote effective facilitation and supportive healing with psychedelic medicines.

“It’s a pleasure to see our work published in this respected journal. In developing EMBARK, we looked at 17 models of psychedelic-assisted psychotherapy, and we noticed that many are missing critical elements: a focus on ethics, on human relationships, on the body as a site of somatic healing, and on evidence-based practices. We designed EMBARK to overcome some of these limitations as an integrative model of psychedelic therapy. We’d like to honor the contributions of many teachers and leaders in the field who have helped chart this course,” said Alex Belser, PhD, EMBARK’s co-creator and Cybin’s Chief Clinical Officer.

The article was published on June 2, 2022 in the peer-reviewed journal Frontiers in Psychology and is titled, “Models of Psychedelic-Assisted Psychotherapy: A Contemporary Assessment and an Introduction to EMBARK, a Transdiagnostic, Trans-Drug Model.” Written by EMBARK’s co-creators, Bill Brennan, PhD and Alex Belser, PhD, Cybin’s Chief Clinical Officer, the article provides a detailed overview of EMBARK to the academic and clinical communities. Frontiers in Psychology is the largest journal in the field of psychology.

“We are excited to present our model to the field in a way that highlights its thoughtfulness and responsiveness to current concerns in psychedelic research. We have listened carefully to what has worked, and what has been found lacking, and offer EMBARK as an innovative step forward,” said Bill Brennan, PhD, EMBARK’s co-creator.

The article also provides an overview of EMBARK’s six clinical domains (Existential-Spiritual, Mindfulness, Body Aware, Affective-Cognitive, Relational, and Keeping Momentum) and highlights the strengths and limitations of existing psychedelic-assisted psychotherapy approaches and evidence-based therapies. The article is the first of a series of publications aimed at presenting EMBARK as an open-source model of practice and training for therapists and facilitators supporting psychedelic-based treatments.

“If psychedelics are ever to be integrated into modern clinical medicine, the usage protocols are as important as the medicines themselves. In this respect Cybin is a leader. Cybin has assembled a faculty of top-notch therapists to lead its EMBARK program, which incorporates a multi-dimensional approach to therapies that enable them to be tailored to a variety of patient needs. With the implementation of EMBARK, Cybin is setting high standards for the future of psychedelic therapy,” said Dennis J. McKenna, Ph.D., Founding Board Member of Heffter Research Institute and President and Principal Founder of McKenna Academy of Natural Philosophy.

The article can be accessed online here.

Cybin’s upcoming clinical trials evaluating the Company’s proprietary psychedelic-based molecules CYB003 and CYB004 for treating major depressive disorder, alcohol use disorder, and anxiety disorders will use EMBARK to support study participants.

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 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’s 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 the Company 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 makes no medical, treatment or health benefit claims about Cybin’s 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 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 verified such in clinical trials or that Cybin will complete such trials. If Cybin 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.

Investor & Media Contact:
Leah Gibson
Vice President, Investor Relations & Strategic Communications
Cybin Inc.
irteam@cybin.com -or- media@cybin.comSource: Cybin Inc.

Cybin Submits IND Application to FDA for its Phase 1/2a First-in-Human Trial of CYB003 for the Treatment of Major Depressive Disorder

Cybin Submits IND Application to FDA for its Phase 1/2a First-in-Human Trial of CYB003 for the Treatment of Major Depressive Disorder

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

TORONTO–(BUSINESS WIRE)– Cybin Inc. (NEO:CYBN) (NYSE American: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. “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.

The Company 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 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, 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’s 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 the Company 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 makes no medical, treatment or health benefit claims about Cybin’s 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 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 verified such in clinical trials or that Cybin will complete such trials. If Cybin 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.

Investor & Media:
Leah Gibson
Vice President, Investor Relations & Strategic Communications
Cybin Inc.
irteam@cybin.com – or – media@cybin.comSource: Cybin

Cybin to Participate in NYSE Trading Bell Ceremony on May 18, 2022

Cybin to Participate in NYSE Trading Bell Ceremony on May 18, 2022

– In-person investor meetings taking place on May 18 and 19 in New York City –

TORONTO–(BUSINESS WIRE)– Cybin Inc. (NEO:CYBN) (NYSE American:CYBN) (Cybin or the Company), a biopharmaceutical company focused on progressing “Psychedelics to TherapeuticsTM” is pleased to announce that it will participate in the morning trading bell ceremony on May 18, 2022 at the New York Stock Exchange (“NYSE”) in New York City.

Cybin, whose shares commenced trading on the NYSE American on August 5, 2021, was the first psychedelics company to be listed on the NYSE.

“We are delighted to be part of this ceremony as we celebrate the innovation that Cybin is bringing to the challenges of mental health treatments today. As we progress from promising preclinical studies toward first-in-human trials, we are steadfastly committed to bringing improved therapeutic options to the millions of people who can benefit from our psychedelic-based therapies as quickly as possible,” said Doug Drysdale, Chief Executive Officer of Cybin.

Cybin’s management team will host in-person meetings with institutional investors on May 18 and 19 in New York City. If you would like to schedule a meeting, please contact Cybin Investor Relations at ir@cybin.com or call 917-543-9932.

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 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’s 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 the Company 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 makes no medical, treatment or health benefit claims about Cybin’s 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 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 verified such in clinical trials or that Cybin will complete such trials. If Cybin 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.

Investor & Media Contacts:
Leah Gibson
Vice President, Investor Relations & Strategic Communications
Cybin Inc.
leah@cybin.comSource: Cybin Inc.

Cybin to Present at the H.C. Wainwright Global Investment Conference on May 25, 2022

Cybin to Present at the H.C. Wainwright Global Investment Conference on May 25, 2022

TORONTO–(BUSINESS WIRE)– Cybin Inc. (NEO:CYBN) (NYSE American:CYBN) (“Cybin” or the “Company”), a biopharmaceutical company focused on progressing “Psychedelics to TherapeuticsTM” is pleased to announce that Doug Drysdale, Cybin’s Chief Executive Officer, will participate in a fireside chat at the H.C. Wainwright Global Investment Hybrid Conference being held at the Fontainebleau Miami Beach May 23-26, 2022.

Mr. Drysdale’s fireside chat will be webcast live on Wednesday, May 25, 2022 at 12:30 p.m. ET. To listen to the event, please click here to access the webcast. The archived webcast will also be available on the Company’s investor relations website on the Events & Presentations page.

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 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.

Investors & Media:
Leah Gibson
Vice President, Investor Relations & Strategic Communications
Cybin Inc.
leah@cybin.comSource: Cybin Inc.

How ketamine affects the brain over time

Cybin and Kernel Announce Results from Kernel Flow® Piloting of Feasibility Study Measuring Ketamine’s Effects on the Brain

The results from Cybin and Kernel’s brain imaging study are in!

The findings suggest that a single dose of ketamine has a lasting effect on the way information flows through the brain.

Subjects’ brain activity patterns were relatively stable for 5 days leading up to the ketamine session.

After a low dose of ketamine, there were significant changes in functional connectivity lasting at least 5 days. 

Top images: Johnson’s absolute functional connectivity for minutes 5-15 after he received the 57.75mg intramuscular injection of Ketamine. Bottom images: Johnson’s relative functional connectivity changes after the Ketamine took effect starting at minutes 15-25. (Graphic: Business Wire)

PDF of article

Cybin Announces CYB003 Poster to be Presented at the ‘From Research to Reality’ Global Summit on Psychedelic-Assisted Therapies and Medicine

Cybin Announces CYB003 Poster to be Presented at the ‘From Research to Reality’ Global Summit on Psychedelic-Assisted Therapies and Medicine

TORONTO–(BUSINESS WIRE)– Cybin Inc. (NEO:CYBN) (NYSE American:CYBN) (Cybin or the Company), a biopharmaceutical company focused on progressing “Psychedelics to TherapeuticsTM”, today announced that an abstract highlighting preclinical data for its deuterated psilocybin analog CYB003 has been selected for a poster presentation at the ‘From Research to Reality’ Global Summit on Psychedelic-Assisted Therapies and Medicines taking place May 27-29, 2022, in Toronto, Canada. The poster is titled Pharmacological and Pharmacokinetic Profile of CYB003, A Novel, Orally Active Analog of Psilocybin.

“It is an honor to participate in this inaugural conference devoted to psychedelic-assisted therapy and to be part of the rigorous scientific work being done in the field,” said Doug Drysdale, Chief Executive Officer of Cybin. “The findings from our preclinical studies on CYB003 that will be highlighted at the Summit will show that, compared to psilocybin, CYB003 may provide therapeutic benefit across a shorter clinical visit and with improved dosing accuracy resulting in improved tolerability for patients. We look forward to the opportunity to engage with leading scientists and academics in the field with the goal of advancing these treatments and improving the lives of those living with mental illness and substance use disorders.”

Presentation Details:
Abstract Title:
 Pharmacological and Pharmacokinetic Profile of CYB003, A Novel, Orally Active Analog of Psilocybin
Authors: Geoffrey Varty, Amy Reichelt, Michael Morgan, Joan Krakowsky, Clinton Canal, Tina Mueller, Ken Avery, Pradip Pathare, Joshua Hartsel, Alex Belser, Aaron Bartlone, Doug Drysdale, Alex Nivorozhkin, Michael Palfreyman
Track: The abstract will be part of a dedicated track to examine the use of psychedelics in the treatment and management of substance use disorders, including nicotine, cocaine, alcohol, and opioids.

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 for an overall better outcome for patients. CYB003 has the potential to effectively treat major depressive disorder (MDD) and alcohol use disorder (AUD).

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, 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’s 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 the Company 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 makes no medical, treatment or health benefit claims about Cybin’s 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 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 verified such in clinical trials or that Cybin will complete such trials. If Cybin 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.

Investors & Media:
Leah Gibson
Vice President, Investor Relations & Strategic Communications
Cybin Inc.
leah@cybin.comSource: Cybin Inc.

Cybin to Participate in the KCSA Psychedelics Virtual Investor Conference on April 28, 2022

Cybin to Participate in the KCSA Psychedelics Virtual Investor Conference on April 28, 2022

TORONTO–(BUSINESS WIRE)– Cybin Inc. (NEO:CYBN) (NYSE American:CYBN) (“Cybin” or the “Company”), a biopharmaceutical company focused on progressing “Psychedelics to Therapeutics™” is pleased to announce that Doug Drysdale, Cybin’s Chief Executive Officer, will present at the KCSA Psychedelics Virtual Investor Conference at 11:00 a.m. ET on Thursday, April 28, 2022.

This will be a live, interactive online event where investors are invited to ask the Company questions in real-time. To participate, please click here to register for the conference and access the webcast. The archived webcast will also be available on the Company’s investor relations website on the Events & Presentations page.

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, 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.

Investor & Media Contacts:
Leah Gibson
Vice President, Investor Relations & Strategic Communications
Cybin Inc.
leah@cybin.comSource: Cybin Inc.

Cybin Partners with Clinilabs Drug Development Corporation for Phase 1/2a Trial Evaluating CYB003 for the Treatment of Major Depressive Disorder

Cybin Partners with Clinilabs Drug Development Corporation for Phase 1/2a Trial Evaluating CYB003 for the Treatment of Major Depressive Disorder

TORONTO–(BUSINESS WIRE)– Cybin Inc. (NEO:CYBN) (NYSE American:CYBN) (Cybin or the Company), a biopharmaceutical company focused on progressing “Psychedelics to TherapeuticsTM”, today announced that it has partnered with Clinilabs Drug Development Corporation (“Clinilabs”), a global, full-service contract research organization with deep expertise in central nervous system drug development, to carry out the Company’s Phase 1/2a clinical trial of CYB003, a proprietary deuterated psilocybin analog. CYB003 will be the first psilocybin analog to be evaluated in Phase 1/2a development for the treatment of major depressive disorder (“MDD”).

“We are delighted to partner with the Clinilabs team as we progress this important program toward a first-in-human Phase 1/2a trial. Clinilabs brings a unique combination of scientific and operational experience and deep expertise in clinical research across a range of psychiatric, neurological and substance use disorders,” said Doug Drysdale, Chief Executive Officer of Cybin. “Clinilabs is ideally suited to help us accelerate the regulatory pathway for this promising treatment candidate and ultimately, to effectively treat those suffering with MDD.”

In multi-species preclinical studies, CYB003 demonstrated significant advantages over classic psilocybin including, less variability in plasma levels, faster onset of action, shorter duration of effect and potentially better tolerability for an overall better outcome for patients. Cybin recently announced the completion of its IND-enabling in vivo preclinical studies of CYB003. Data from these studies support the advancement toward an investigational new drug (“IND”) filing with the U.S. Food and Drug Administration (“FDA”) for the Phase 1/2a clinical trial. Cybin intends to submit an IND to the FDA in the second quarter of 2022 and expects to initiate the Phase 1/2a trial in mid-2022.

“Approximately one-third to one-half of people with MDD demonstrate an inadequate response to antidepressant drug treatment. Treatment options for these patients currently are limited to dose escalation, switching or combining antidepressants, or augmentation therapy, often with unsatisfactory results,” said Dr. Gary Zammit, President & CEO of Clinilabs. “It is a privilege to be working with Cybin, an innovator in the development of novel psychedelic therapeutics, to conduct its first-in-human clinical trial of CYB003. This trial is designed to assess the efficacy and safety of CYB003 in patients with MDD and is among the first to evaluate a standardized psychedelic treatment regimen in this patient population.”

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 that has the potential to effectively treat major depressive disorder and alcohol use disorder.

About Clinilabs Drug Development Corporation
Clinilabs Drug Development Corporation is the only global, full-service contract research organization (CRO) focused exclusively on central nervous system (“CNS”) drug development. With deep expertise in CNS, we are committed to the development of medicines that treat a range of psychiatric, neurological and substance use disorders, as well as rare and ultra-rare CNS diseases. Clinilabs partners with pharmaceutical and biotechnology companies to deliver a complete, first-in-human to Phase 3 spectrum of high quality, timely, and cost-effective clinical drug development services, with the shared goal of speeding new CNS medicines to market. We are process-driven yet structured to be nimble, providing personalized service that meets the needs of customers and projects of all sizes. Clinilabs has conducted more than 675 CNS clinical trials in our 21-year history and played a pivotal role in the approval of 19 new therapies across 10 CNS indications to help transform the lives of patients worldwide.

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, 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’s 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 the Company 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 makes no medical, treatment or health benefit claims about Cybin’s 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 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 verified such in clinical trials or that Cybin will complete such trials. If Cybin 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.

Investors & Media:
Leah Gibson
Vice President, Investor Relations & Strategic Communications
Cybin Inc.
leah@cybin.com

Jeanine M. Falinski, MBA
Vice President, Marketing & Communications
Clinilabs Drug Development Corporation
jfalinski@clinilabs.comSource: Cybin Inc.