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Cybin Announces Positive CYB003 Data Demonstrating Significant Advantages Over Oral Psilocybin for Treatment of Mental Health

Cybin Announces Positive CYB003 Data Demonstrating Significant Advantages Over Oral Psilocybin for Treatment of Mental Health

Comparative CYB003 pre-clinical data on the Company’s deuterated psilocybin analog may have wide-reaching implications for the treatment of Major Depressive Disorder (“MDD”) and Alcohol Use Disorder (“AUD”) with less patient variability, faster onset of action, shorter duration of effect and improved brain penetration

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 positive CYB003 pre-clinical findings that demonstrate multiple advantages for its newly developed novel deuterated psilocybin analog over oral psilocybin for the treatment of mental health.

“Multiple academic studies have shown that psilocybin may have the potential to revolutionize mental healthcare, but few companies have addressed the well-known limitations and side effects of oral psilocybin. Cybin has always strived to develop safer and more effective therapies for patients, which has guided our multiple psilocybin programs: CYB001, CYB002, and CYB003,” said Doug Drysdale, Cybin’s Chief Executive Officer.

Academic research performed at New York University and John Hopkins University has indicated oral psilocybin to be efficacious in the treatment of mental health disorders, especially MDD, but with significant limitations, specifically: slow onset of action, extended duration of effect, and a variability in response among patients. The Company’s CYB001 and CYB002 programs studied proprietary formulations, while the Company’s CYB003 program explored proprietary analogs with the goal to retain the benefits and address the challenges. Today the Company is pleased to announce that its proprietary molecular advancements offer positive benefits and address the challenges and limitations of oral psilocybin.

In multi-species pre-clinical studies, the Company’s deuterated psilocybin analog from its CYB003 program demonstrates:

  • a 50% reduction in variability compared to oral psilocybin; indicates potential for more accurate dosing in patients with MDD and AUD;
  • a 50% reduction in dose compared to oral psilocybin; indicates potential to maintain equivalent efficacy while reducing side effects, such as nausea, in patients with MDD and AUD;
  • a 50% shorter time to onset when compared to oral psilocybin; indicates potential for shorter duration of treatment, lower inter-subject variability, better therapeutic control and safety, leading to a better patient experience, with lower cost and scalability; and
  • nearly double brain penetration when compared to oral psilocybin; indicates potential for a less variable treatment response, a lower dose therapeutic effect, and reduced patient side effects.

The deuterated psilocybin analog in CYB003 has the potential to reduce time and resource burden on patients, providers and payers, and possibly improving scalability and accessibility​ from the following conclusions:

  • faster onset of action equates to less down time in the clinic before effects begin;
  • half the duration of effect translates to shorter clinic days or more patients per day;
  • more predictable dose effects create a safer and more effective patient response;
  • lowered peripheral exposure diminishes the risk of nausea; and
  • better brain penetration suggests lower overall dose needed to achieve clinical efficacy.

“While we are all encouraged by the benefits of psilocybin, we need to transparently and openly discuss its limitations if we are to translate psychedelics to therapeutics for patients in need. The majority of current clinical studies are based on psilocybin. We have taken the necessary steps to potentially unlock the powerful benefits of psychedelics and engineer a superior molecule as demonstrated by the data. We are on a mission to make ethical, safe scientific progress to advance the care and treatment of mental health patients. Our goal has always been to be a leader in creating the best therapy for patients, today we move one step closer,” said Doug Drysdale, Cybin’s Chief Executive Officer.

The presentation showcasing the Company’s data will be made available on the Cybin website within 24 hours.

As a reminder, the Company welcomes all media and analysts that are attending the Wonderland Conference in Miami to physically join its presentation today at 8:30am EDT.

Physical address for attendees:

Physical event is for media attendees and analysts only. To RSVP, please email info@cybin.com.

The Adrienne Arsht Center for the Performing Arts
Next Generation Green Room
Arts of Miami-Dade County, Inc.
1300 Biscayne Blvd. Miami, FL 33132

The Company welcomes shareholders and the general public to virtually join its presentation today at 8:30am EDT.

Virtual Webcast:

Virtual event is open to shareholders and the general public.

Topic: Cybin Research & Development Press Conference
Location: Wonderland Conference, Miami, FL
Time: Nov 8, 2021 08:30 AM Eastern Time (US and Canada)

Join Zoom Meeting
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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 the USA, UK 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 potential benefits of the Company’s multiple psilocybin program CYB001, CYB002, and CYB003, the potential benefits of psilocybin, and the development of the Company’s proprietary drug discovery platforms, innovative drug delivery systems, novel formulation approaches and treatment regimens in order to advance the care and treatment of mental health patients and to address a multitude of mental health issues.

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 June 30, 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 or nutraceutical products. 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 or nutraceuticals can diagnose, treat, cure or prevent any disease or condition. Vigorous 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
Cybin Inc.
leah@cybin.com

Tim Regan/Scott Eckstein
KCSA Strategic Communications
cybin@kcsa.com

Lisa M. Wilson
In-Site Communications, Inc.
lwilson@insitecony.com

Source: Cybin Inc.

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Cybin Granted DEA Schedule I Manufacturing License

Cybin Granted DEA Schedule I Manufacturing License

The Company Also Welcomes Leah Gibson as its New Vice President of Investor Relations

TORONTO, CANADA – November 4, 2021 – Cybin Inc.(NEO:CYBN) (NYSE American:CYBN) (“Cybin” or the “Company”), a biopharmaceutical company focused on progressing “Psychedelics to Therapeutics TM”, today announced that the Company has been granted a Schedule I manufacturing license from the U.S. Drug Enforcement Agency (“DEA”). The DEA license is a federal requirement for any investigators who intend to study, produce, analyze or otherwise work with Schedule I controlled substances.

The DEA license is for the Company’s research lab in the Boston area. The license will allow the Company to further become a hub for innovation and drug discovery. Previously, the Company conducted much of its research and development (“R&D”) work through globally licensed research organizations in the U.S., Canada, and the U.K., and through certain in-house capabilities. With the DEA license, the Company will be able to vastly expand its internal R&D capabilities to support innovative drug discovery and delivery involving Schedule I compounds.

“We are pleased with the progression of our clinical and regulatory efforts since the Company’s formation. This new license further positions the Company as a truly integrated biopharmaceutical company that can continue to work towards progressing Psychedelics to Therapeutics,” said Doug Drysdale, Cybin’s Chief Executive Officer.

The Company is also pleased to announce the appointment of Leah Gibson to the position of Vice President of Investor Relations. Leah is a life sciences investor relations leader with more than 18 years of experience in corporate and shareholder communications, and business strategy development. She has spearheaded multiple strategic investor relations programs including an award-winning and best-in-class program responsible for driving $1.1B in institutional open-market investments over 12 months and increasing international shareholder presence. Leah has vast experience in working with small-cap and large-cap publicly traded biotechnology companies, including a $60B large-cap biotechnology company focused on creating transformative medicines for serious diseases.

As a transition with Leah Gibson becoming the new Vice President of Investor Relations, the Company also today announced that John Kanakis will step down from his Chief Business Officer position which was primarily focused on the management of investor and media relations functions. He will continue with the Company in a role to focus on M&A and business development opportunities.

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 the USA, UK 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 June 30, 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 or nutraceutical products. 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 or nutraceuticals can diagnose, treat, cure or prevent any disease or condition. Vigorous 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

Cybin Inc.

leah@cybin.com

 

Tim Regan/Scott Eckstein

KCSA Strategic Communications

cybin@kcsa.com

 

Lisa M. Wilson

In-Site Communications, Inc.

lwilson@insitecony.com

‍

Posted on

Cybin Hosting Research and Development Briefing on November 8, 2021

Cybin Hosting Research and Development Briefing on November 8, 2021

Breakthrough pre-clinical, research findings to be released show therapeutic advancements on the data-driven evolution of psychedelic psilocybin molecule

TORONTO, CANADA – November2, 2021 – Cybin Inc. (NEO:CYBN) (NYSE American:CYBN) (“Cybin” or the “Company”), a biopharmaceutical company focused on progressing “Psychedelics to Therapeutics™”, will host an in-person and virtual research and development (“R&D”) briefing releasing positive research findings and data on Monday, November 8, 2021 from 8:30am to 9:30 am (EST) on the advancements to create a promising approach for patients in need of effective and safe prescription therapies in the mental health space. Founded in October 2019, Cybin is a company that has evolved in many ways on its journey to create ethical and equitable scientific platforms.

Cybin’s leadership, including CEO Doug Drysdale and the Company’s senior scientific research team, are hosting the R&D briefing. The in-person session will take place at the Adrienne Arsht Center for the Performing Arts, within the Green Room, at the Wonderland Conference in Miami. Log-in details for the webcast for virtual attendees can be found below. The event will be followed by a Q&A session.

The evolution within the Company continues to align with its “Psychedelics to Therapeutics” approach by harnessing already known attributes of classical psychedelics and engineering them into commercially viable therapeutics. The Company’s comparative pre-clinical data clearly shows multiple potential advantages over classical psychedelic molecules. This data and the molecular possibilities may have wide-reaching implications for the treatment of mental health.

“We are on a mission to create safe and effective therapeutics for patients to address a multitude of mental health issues. At a time when COVID has exacerbated the mental health crisis to epidemic proportions, the Cybin team has been exceptionally productive. We are excited to share the deeply meaningful scientific progress that we have made. You will not want to miss this,” said Drysdale.

Speakers at the R&D eventinclude:

Doug Drysdale – Chief Executive Officer

Michael Palfreyman, Ph.D. – Chief R&D Officer

Geoff Varty, Ph.D. – Head of R&D

Aaron Bartlone – Chief Operating Officer

‍

Physical address for attendees:

Physical event is for media attendees and analysts only. To RSVP, please email info@cybin.com.

The Adrienne Arsht Center for the Performing Arts

Next Generation Green Room
Arts of Miami-Dade County, Inc.
1300 Biscayne Blvd. Miami, FL 33132

‍

Virtual Webcast:

Virtual event is open to shareholders and the general public.

Topic: Cybin Research & Development Press Conference

Location: Wonderland Conference, Miami, FL

Time: Nov 8, 2021 08:30 AM Eastern Time (US and Canada)

Join Zoom Meeting

https://imageav.zoom.us/j/82993672583?pwd=cW9zQi9Xc1BCbExpTGh5T09aS1hGUT09

One tap mobile

+13462487799,,82993672583#,,,,*730988# US

 

Dial by your location

Meeting ID: 829 9367 2583

Passcode: 730988

Find your local number: https://imageav.zoom.us/u/kWOoByjaK

‍

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 the USA, UK 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 June 30, 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 or nutraceutical products. 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 or nutraceuticals can diagnose, treat, cure or prevent any disease or condition. Vigorous 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 Contacts: 

Tim Regan/Scott Eckstein

KCSA Strategic Communications

Cybin@kcsa.com

Lisa M. Wilson

In-Site Communications, Inc.

lwilson@insitecony.com

 

Media Contact: 

John Kanakis

Cybin Inc.

John@cybin.com

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A new tool to understand the brain

Kernel’s Brain-Imaging Helmet Approved For Clinical Trial On Patients Using Ketamine

An LA-based company called Kernel developed a brain-imaging helmet that can track what actually happens in the brain during a psychedelic trip.

The device, called Kernel Flow, was just approved by the FDA to be used in a ketamine trial sponsored by Cybin (CYBN).

Researchers will use the helmet to measure the neurological activity of 15 patients during a ketamine therapy session compared to baseline activity.

Kernel Flow is much less expensive than other brain-imaging tools and allows the patients to move freely during the session.

PDF of article

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Tripping on an island to help frontline workers

Cybin Announces Launch of EMBARK Psychedelic Facilitator Training Program

Cybin (CYBN) is sending therapists on a psychedelic retreat so they can learn how to provide support to frontline healthcare workers.

Clinical trial facilitators will head to a small island in Washington to be trained on Cybin’s new EMBARK therapy model and gain experiential knowledge of psychedelics. The EMBARK model combines aspects of several psychotherapy models and incorporates patients’ spiritual experiences, bodily experiences, and relationships into the healing process.

The retreat will prepare the facilitators for an upcoming clinical trial at the University of Washington that aims to treat healthcare workers suffering from COVID-related distress, depression, anxiety, and PTSD.

PDF of article

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Cybin Announces FDA Investigational New Drug Authorization of Cybin’s Sponsored Feasibility Study Using Kernel Flow Technology

Cybin Announces FDA Investigational New Drug Authorization of Cybin’s Sponsored Feasibility Study Using Kernel Flow Technology

TORONTO–(BUSINESS WIRE)– Cybin Inc. (NEO:CYBN) (NYSE American:CYBN) (“Cybin” or the “Company”), a biotechnology company focused on progressing psychedelic therapeutics, today announced that the U.S. Food and Drug Administration (“FDA”) has authorized an Investigational New Drug (“IND”) application to proceed with the Company’s sponsored feasibility study using Kernel’s Flow technology to measure ketamine’s psychedelic effect on cerebral cortex hemodynamics.

“The word psychedelic means ‘mind-manifesting,’ but what has been missing is useful ‘mind-imaging’—the ability to dynamically trace the neural correlates of human conscious experience. Conventional neuroimaging just isn’t dynamic enough to study the psychedelic experience in the brain as it happens. This study of ketamine’s psychedelic effects while wearing headgear equipped with sensors to record brain activity could open up new frontiers of understanding,” said Dr. Alex Belser, Cybin’s Chief Clinical Officer.

Leveraging Kernel’s quantitative neuroimaging technology (“Kernel Flow”) may lead to new frontiers in psychedelic therapeutics by enabling the acquisition of longitudinal brain activity before, during and after a psychedelic experience, providing quantification of what was previously subjective patient reporting.

“Quantitatively measuring the brain within the context of a psychedelic experience is a promising frontier,” said Bryan Johnson, founder and Chief Executive Officer of Kernel. “With Kernel Flow, Cybin’s researchers can start putting numbers and quantification to subjective states of mind, including altered ones.”

Kernel Flow uses pulsed light instead of continuous wave light to increase measured brain information. In contrast with electroencephalography (“EEG”) electrodes that usually require gel on the head or functional magnetic resonance imaging (“fMRI”) studies that require a participant to lie in a scanner, Kernel Flow is easily wearable. The entire system is the size and look of a bicycle helmet and could, in the future, be more broadly used for neuroscientific or physiological studies of brain activity during psychedelic use.

As part of Cybin’s sponsorship of the feasibility study, the Company will retain an exclusive interest in any innovations that are discovered or developed through its independent analysis of the study findings. Kernel will hold the same rights relating to its Kernel technology.

“We hope this feasibility study can bridge the gap of real-time quantitative data collection during psychedelic treatments to further understand the correlation of effects from these powerful molecules. The ability to access real-time brain activity data during a psychedelic experience has tremendous potential for the development of future psychedelic therapeutics,” stated Doug Drysdale, Chief Executive Officer of Cybin.

About Cybin

Cybin is a leading biotechnology company focused on progressing psychedelic therapeutics by utilizing proprietary drug discovery platforms, innovative drug delivery systems, novel formulation approaches and treatment regimens for psychiatric 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 June 30, 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 or nutraceutical products. 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 or nutraceuticals can diagnose, treat, cure or prevent any disease or condition. Vigorous 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 Contacts:
Tim Regan/Scott Eckstein
KCSA Strategic Communications
Cybin@kcsa.com

Lisa M. Wilson
In-Site Communications, Inc.
lwilson@insitecony.com

Media Contact:
John Kanakis
Cybin Inc.
john@cybin.com

Source: Cybin Inc.

Posted on

74 studies on 50 compounds

Cybin Announces Completion of 74 Pre-Clinical Psychedelic Molecule Studies

This week, Cybin Inc. (CYBN) completed its 74th preclinical study to advance its proprietary molecules, CYB003 and CYB004, toward clinical research.

The company has evaluated 50 novel compounds in its preclinical research, narrowing it down to four lead candidates. including CYB003 for alcohol use disorder and CYB004 for anxiety disorders. The formulations are showing faster onset times, shorter durations, high oral bioavailability, significant brain penetration, and less variability between subjects compared to classic psychedelics.

Human clinical trials are expected to commence early next year to work toward an Investigational New Drug (IND) status.

PDF of article

Posted on

Cybin Announces Completion of 74 Pre-Clinical Psychedelic Molecule Studies

Cybin Announces Completion of 74 Pre-Clinical Psychedelic Molecule Studies

–The Company expects to hold a Research & Development event to review these breakthrough findings in Q4 2021 that will be open to the public, shareholders, analysts and the media–

TORONTO–(BUSINESS WIRE)– Cybin Inc. (NEO:CYBN) (NYSE American:CYBN) (“Cybin” or the “Company”), a biotechnology company focused on progressing psychedelic therapeutics, today announced the completion of its 74th pre-clinical study as it continues to progress its proprietary psychedelic molecules into Investigational New Drug (“IND”)-enabling studies.

Cybin’s Research and Development team has completed 74 in-vitro and in-vivo evaluations of Cybin’s expanding portfolio of psychedelic compounds being designed for potential therapeutic applications for several mental health conditions. To date, more than 50 novel compounds have been evaluated through collaborations with experienced contract research organizations for pharmacokinetic/pharmacodynamic profile, metabolic stability, receptor binding, and safety in order to identify preferred candidates for further development.

The Company aims to create a world class portfolio of psychedelic molecules that can become commercially viable drug candidates for both internal development and through future development partnerships.

Research and development highlights:

  • completed 74th pre-clinical research and development study in support of advancing CYB003 and CYB004 and other molecules towards clinical development;
  • comparative data clearly shows multiple potential advantages over classical psychedelic molecules that include faster onset of action, shorter duration of action, excellent oral bioavailability, significant brain penetration and significantly less inter-subject variability. It is suggested that these properties may translate to significantly better patient experiences;
  • safety and toxicology studies to U.S. Food and Drug Administration (“FDA”) standards have been initiated in preparation for human clinical studies, expected in early 2022; and
  • significant progress in preparing CYB003 and CYB004 drug substance to FDA standards for human use has been achieved in partnership with an FDA approved manufacturer.

“Cybin continues to demonstrate superior properties of its CYB003 and CYB004 programs as we progress toward first-in-human studies, expected in early 2022. These experiments greatly expand our understanding of the potential therapeutic value of the studied compounds and further demonstrate Cybin’s strong research and development capabilities,” said Doug Drysdale, Cybin’s CEO.

About Cybin

Cybin is a leading biotechnology company focused on progressing psychedelic therapeutics by utilizing proprietary drug discovery platforms, innovative drug delivery systems, novel formulation approaches and treatment regimens for psychiatric 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 June 30, 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 or nutraceutical products. 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 or nutraceuticals can diagnose, treat, cure or prevent any disease or condition. Vigorous 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 Contacts:
Tim Regan/Scott Eckstein
KCSA Strategic Communications
Cybin@kcsa.com

Lisa M. Wilson
In-Site Communications, Inc.
lwilson@insitecony.com

Media Contact:
John Kanakis
Cybin Inc.
John@cybin.com

Source: Cybin Inc.

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Never leave home without your inhaler ;)

Cybin Files an International Patent Application Covering Psychedelic Delivery Methods

Cybin Inc. (CYBN) developed a new device that delivers psychedelic medicine through inhalation.

Inhaling psychedelics could be superior to oral administration, as it could result in optimized session timing, lower doses, and greater control for healthcare providers.

The company filed an international patent application for the method and the device, which has potential to gain coverage in 153 countries.

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Cybin Files an International Patent Application Covering Psychedelic Delivery Methods

Cybin Files an International Patent Application Covering Psychedelic Delivery Methods

TORONTO–(BUSINESS WIRE)– Cybin Inc. (NEO:CYBN) (NYSE AMERICAN:CYBN) (“Cybin” or the “Company”), a biotechnology company focused on progressing psychedelic therapeutics, today announced that it has filed an international patent application related to methods for the delivery of psychedelic medications by inhalation and devices for performing those methods.

The application, governed by the Patent Cooperation Treaty (“PCT”), brings the potential to obtain patent coverage in 153 countries.

The Company believes that the delivery of psychedelic medications using inhalation may overcome key obstacles encountered by traditional oral drug administration. Specifically, the Company expects inhalation delivery to facilitate optimized psychedelic session timing compared to oral administration of the same compounds, lower doses of psychedelic therapeutics while preserving efficacy, and providing health care providers with more control during psychedelic sessions.

Filed in support of the Company’s CYB004 pre-clinical development program, the PCT filing serves to increase the Company’s library of drug delivery modalities directed to optimal delivery of psychedelics and further strengthens Cybin’s growing IP portfolio.

The PCT filing also includes support for future research programs respecting various systems which seek to minimize negative side effects in psychedelic psychotherapy patients, methods that enable lower and sub-psychedelic doses without impacting treatment efficacy and increasing the long-term efficacy of psychedelic sessions.

“The continued progression of our research programs guides our discovery of new molecules and differentiating treatment approaches. Continued innovation, as demonstrated by our expanding IP portfolio, positions Cybin as a leading innovator in the development of putative psychedelic treatments for a variety of mental health conditions,” said Doug Drysdale, the company’s CEO.

About Cybin
Cybin is a leading biotechnology company focused on progressing psychedelic therapeutics by utilizing proprietary drug discovery platforms, innovative drug delivery systems, novel formulation approaches and treatment regimens for psychiatric 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 development of innovative drug delivery systems, novel formulation approaches and potential treatment regimens for psychiatric disorders and proprietary development strategy and development of medicinal psychedelics with improved dosing efficacy and therapeutic indices to address unmet medical needs.

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 three months ended June 30, 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 or nutraceutical products. 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 or nutraceuticals can diagnose, treat, cure or prevent any disease or condition. Vigorous 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.

The Neo Exchange Inc. has neither approved nor disapproved the contents of this news release and is not responsible for the adequacy and accuracy of the contents herein.

Investor Contacts:
Tim Regan/Scott Eckstein
KCSA Strategic Communications
Cybin@kcsa.com

Lisa M. Wilson
In-Site Communications, Inc.
lwilson@insitecony.com

Media Contact:
John Kanakis
Cybin Inc.
John@cybin.com

Source: Cybin Inc.