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Cybin Inc. Reports Fiscal Year 2022 Financial Results and Recent Business Highlights

Cybin Inc. Reports Fiscal Year 2022 Financial Results and Recent Business Highlights

– Company reiterates key pipeline and strategic milestones for 2022 –

TORONTO–(BUSINESS WIRE)– Cybin Inc. (NEO:CYBN) (NYSE American:CYBN) (“Cybin” or the “Company”), a biopharmaceutical company focused on progressing “Psychedelics to TherapeuticsTM”, today reported audited financial results for its fiscal year ended March 31, 2022 and recent business highlights. The Company also reiterated its anticipated pipeline and strategic milestones for the remainder of 2022.

“Cybin made important progress across the board in recent months, accelerating both our pipeline of proprietary investigational psychedelic-based treatments and strategic partnership programs. Our successful preclinical work has set the foundation for a seamless transition to in-human trials,” said Doug Drysdale, Chief Executive Officer of Cybin. “Over a very short time horizon, we have evolved into a multi-program clinical-stage company, which marks the dedication of the Cybin team to developing improved treatment options for mental health conditions.”

Recent Business and Pipeline Highlights:

  • Announced U.S. Institutional Review Board (“IRB”) approval for its first-in-human Phase 1/2a trial of CYB003 in major depressive disorder (“MDD”). The Company received IRB approval less than two weeks after submitting an Investigational New Drug (“IND”) application to the U.S. Food and Drug Administration. The Company expects to initiate the Phase 1/2a study in mid-2022 pending IND approval with a potential interim data readout expected at the end of 2022.
  • Accelerated clinical development of CYB004 for the potential treatment of anxiety disorders through the planned acquisition of a Phase 1 study from Entheon Biomedical Corp. (“Entheon”).The CYB004-E Phase 1 study is currently underway at the Centre for Human Drug Research in the Netherlands. The study is evaluating the pharmacokinetics (“PK”) and pharmacodynamics of intravenous N,N-dimethyltryptamine (“DMT”) in 50 healthy volunteers who smoke tobacco. This is the largest Phase 1 DMT clinical study conducted to date. The study is expected to provide dose optimization and safety data to guide the clinical path forward for CYB004, the Company’s deuterated DMT molecule, and will replace the previously planned CYB004 pilot study. Preclinical data for CYB004 announced in April 2022 showed significant advantages over inhaled and intravenous DMT, including improved bioavailability, longer duration of effect, and rapid onset of effect and low variability.
  • Strengthened the Company’s IP portfolio with an international patent application for CYB004. In February 2022, Cybin was granted a patent by the U.S. Patent and Trademark Office covering new chemical entity claims for CYB004 and various deuterated forms of DMT and 5-MeO-DMT until 2041. Cybin also announced the publication of an international patent application by the World Intellectual Property Organization covering inhalation delivery methods for multiple psychedelic molecules, including CYB004.
  • Reported positive preliminary data from a pilot study of Kernel Flow®, confirming Flow’s ability to successfully measure psychedelic effects on the brain. Flow is a wearable neuroimaging technology device that can quantify brain activity in real time during a psychedelic experience with the potential to support data-driven, personalized psychedelic treatments. These pilot data from an ongoing feasibility study suggested that Flow measurements confirmed changes in functional connectivity after ketamine dosing, which persisted for several days after administration. The pilot data also validated the design of the ongoing Phase 1 Flow feasibility study.
  • Publication of peer-reviewed journal article in Frontiers in Psychology introducing EMBARK, Cybin’s model of psychedelic-assisted psychotherapy. The EMBARK psychotherapy model will be used to support patients in upcoming clinical trials assessing CYB003 and CYB004 in MDD, alcohol use disorder (“AUD”) and anxiety disorders. The Company has compiled a team of 28 expert faculty and advisors from leading universities and psychedelic research and training organizations for the EMBARK program.

Upcoming Pipeline and Strategic Milestones:

The Company expects to achieve the following milestones across its pipeline and partnership programs:

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

  • The Company expects to initiate its Phase 1/2a placebo-controlled clinical trial of CYB003 in up to 32 MDD patients in the coming weeks.
  • The Company plans to report initial safety and PK data from the Phase 1/2a study in Q4 CY2022.

CYB004: Deuterated DMT for the potential treatment of anxiety disorders

  • The previously announced planned acquisition of a Phase 1 DMT study from Entheon is expected to close in the coming weeks subject to the completion of certain closing conditions and obtaining all necessary approvals.

CYB005: Phenethylamine derivative for the potential treatment of neuroinflammation

  • Cybin plans to report preclinical data for CYB005 in Q3 CY2022 at which time the Company expects to nominate a candidate and complete its assessment of the potential path forward for this candidate, including whether it be internally or by way of potential third party partners.

Kernel Flow®

  • The Phase 1 Flow feasibility study is underway. This is a four-week study assessing the participant’s experience wearing Flow, as well as brain activity, following the administration of ketamine.

“We gain confidence every day in our ability to create a true paradigm shift in the way mental health conditions are understood and treated. By working to develop treatment options that can potentially offer improved efficacy, greater remission rates, and longer duration of effects, we have the potential to provide patients and providers with a new standard of care. We look forward to continued momentum and sharing meaningful data readouts later this year,” Drysdale continued.

Fiscal Year 2022 Financial Highlights:

  • Cash and cash equivalents totaled to C$53.6 million as of March 31, 2022.
  • Cash-based operating expenses totaled C$13.0 million for the quarter ended March 31, 2022, of which C$3.8 million were one-time, non-recurring costs. Non-cash expenses totaled C$5.1 million for a net loss of C$18.1 million.
  • Cash-based operating expenses totaled C$45.8 million for the year ended March 31, 2022, of which C$11.6 were one-time, non-recurring costs. Non-cash expenses totaled C$21.8 million for a net loss of C$67.6 million.
  • Cash flows used in operating activities were C$9.7 million for the quarter ended March 31, 2022 of which C$1.4 million were one-time, non-recurring costs.
  • Cash flows used in operating activities were C$45.2 million for the year ended March 31, 2022 of which C$10.7 million were one-time, non-recurring costs.

“Our financial position remains strong. Despite the overall softness in the markets, we are pleased with our industry leadership position and remain confident that we are on the right path forward to progress psychedelics into therapeutics,” concluded Drysdale.

Additional non-cash consideration in the amount of C$4,655.29 is being issued to the previous shareholders of Adelia Therapeutics Inc. in respect of the achievement of a previously announced milestone on April 1, 2022.

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 news release related to the Company are forward-looking statements and are prospective in nature. Forward-looking statements are not based on historical facts, but rather on current expectations and projections about future events and are therefore subject to risks and uncertainties which could cause actual results to differ materially from the future results expressed or implied by the forward-looking statements. These statements generally can be identified by the use of forward-looking words such as “may”, “should”, “could”, “intend”, “estimate”, “plan”, “anticipate”, “expect”, “believe” or “continue”, or the negative thereof or similar variations. Forward-looking statements in this news release include statements regarding sharing additional data later this year, the Company’s CYB003 Phase 1/2a trial in mid-2022 and anticipated results, the potential closing of the Entheon acquisition, statements regarding the Company’s Phase 1 DMT clinical study for CYB004 and anticipated results, the Company’s plan to report interim safety and PK data from the Phase 1/2a study in Q4 CY2022, the Company’s statements regarding its preclinical data for CYB005 and partnering opportunities, statements regarding the Phase 1 Flow feasibility study and expected results, statements regarding the EMBARK psychotherapy model and anticipated results and the Company’s plans to engineer proprietary drug discovery platforms, innovative drug delivery systems, novel formulation approaches and treatment regimens for mental health conditions.

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 year ended March 31, 2022, and the Company’s annual information form for the year ended March 31, 2022, 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.

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What machine learning tells us about microdosing

Natural language signatures of psilocybin microdosing

The benefits of microdosing can be so subtle that they’re hard to measure in clinical settings, which is why this study turned to machine learning and natural language processing.

Essentially, patients were asked a series of subjective questions following psilocybin microdoses or placebo doses, and the interviews were analyzed with AI.

The key takeaways?

  1. A “sentiment analysis” measured the connotation of each word as positive, negative, or neutral. Sentiment scores increased while microdosing, suggesting that psilocybin has a positive effect on mood and subjective well-being.
  2. Verbosity (length of responses in number of words) increased for all questions when microdosing, which may reflect increased enthusiasm, motivation, and energy.
  3. Semantic variability (how much the meaning of consecutive words changed) was not affected by microdosing. This implies that microdosing does not lead to incoherent speech and might not enhance creativity like many believe. 

It’s important to note that the microdose were fairly large – 500 mg of dried mushrooms. It would be interesting to see how a 100 or 200 mg dose compares.

PDF of article

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Yale’s Department of Psychiatry Chair to Join Clearmind Medicine

Yale’s Department of Psychiatry Chair to Join Clearmind Medicine

Dr. John H. Krystal, world-leading expert in alcoholism and depression, will serve on scientific advisory board

VANCOUVER, June 21, 2022 (GLOBE NEWSWIRE) — Clearmind Medicine Inc. (CSE: CMND, OTC Pink: CMNDF, FSE: CWY0) (“Clearmind” or the “Company“), a biotech company focused on discovery and development of novel psychedelic-derived therapeutics to solve major undertreated health problems, today announced the appointment to its Scientific Advisory Board of John Krystal, Chair of the Psychiatry Department at Yale University’s School of Medicine.

A leading expert on alcoholism, post-traumatic stress disorder, schizophrenia, and depression, Dr. Krystal’s work links psychopharmacology, neuroimaging, molecular genetics, and computational neuroscience to study the neurobiology and treatment of these disorders. He is best known for leading the discovery of the rapid antidepressant effects of ketamine.

“We are truly honored to add Dr. Krystal, one of the world’s most recognized experts in alcoholism, to our Scientific Advisory Board,” said Dr. Adi Zuloff-Shani, Clearmind’s Chief Executive Officer. “Clearmind has emphasized collaboration with scientists and clinicians at ​​the very best academic, medical and research institutions in the world, helping us bring innovative expertise to bear on some of the most pressing global health needs.”

Dr. Krystal is a Professor of Translational Research; Psychiatry, Neuroscience, and Psychology; he chairs the Department of Psychiatry at Yale University; and he is Chief of Psychiatry and Behavioral Health at Yale-New Haven Hospital. He is a graduate of the University of Chicago and the Yale University School of Medicine

Among many other positions he holds or has held, Dr. Krystal is the Director of the NIAAA Center for the Translational Neuroscience of Alcoholism and the Clinical Neuroscience Division of the VA National Center for PTSD, co-director of the Neuroscience Forum of the U.S. National Academies of Sciences, Engineering, and Medicine; and editor of Biological Psychiatry (IF=12.1). He is a member of the U.S. National Academy of Medicine and a Fellow of the American Association for the Advancement of Science.

“We believe that the scientists on our Scientific Advisory Board, working closely with us to challenge, validate and guide our scientific agenda for developing breakthrough therapies that improve human mental-health at scale, increase access to care, reduce suffering and improve health outcomes around the world,” said Zuloff-Shani.

About Clearmind Inc. (CSE: CMND), (OTC: CMNDF), (FSE: CWY0)

Clearmind is a new biotech company focused on the discovery and development of safe and novel psychedelic-derived therapeutics to treat alcohol use disorder and other pressing health challenges.

The Israeli Canadian company holds several patents for the non-hallucinogenic compound MEAI (5-methoxy-2-aminoindane, a novel psychoactive substance). The company intends to seek additional patents for its compounds whenever warranted and will remain opportunistic regarding the acquisition of additional intellectual property to build its portfolio.

Clearmind has established a research collaboration with the Hebrew University of Jerusalem and Bar Ilan University. The partnerships aim to expand its R&D capabilities and discover new candidate treatments for other mental health issues.

For further information, please contact:

Investor Relations

invest@clearmindmedicine.com

Telephone: (604) 260-1566

General Inquiries

Info@Clearmindmedicine.com

www.Clearmindmedicine.com

FORWARD-LOOKING STATEMENTS:

This news release may contain forward-looking statements and information based on current expectations. These statements should not be read as guarantees of future performance or results. Such statements involve known and unknown risks, uncertainties and other factors that may cause actual results, performance or achievements to be materially different from those implied by such statements. Such statements include submission of the relevant documentation within the required timeframe to the satisfaction of the relevant regulators and raising sufficient financing to complete the Company’s business strategy. There is no certainty that any of these events will occur. Although such statements are based on management’s reasonable assumptions, there can be no assurance that such assumptions will prove to be correct. We assume no responsibility to update or revise them to reflect new events or circumstances.

Investing into early-stage companies inherently carries a high degree of risk, and investment into securities of the Company shall be considered highly speculative.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of the securities in any province in which such offer, solicitation or sale would be unlawful. The securities issued, or to be issued, under the Private Placement have not been, and will not be, registered under the United States Securities Act of 1933, as amended, and may not be offered or sold in the United States absent registration or an applicable exemption from registration requirements.

Neither the Canadian Securities Exchange (the “CSE”) nor its Regulation Services Provider (as that term is defined in the policies of the CSE) accepts responsibility for the adequacy or accuracy of this release.

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Ceruvia Lifesciences Submits FDA Investigational New Drug Application for NYPRG-101 Migraine Prevention Program

Ceruvia Lifesciences Submits FDA Investigational New Drug Application for NYPRG-101 Migraine Prevention Program

  • Based on a positive pre-IND meeting with the U.S. Food and Drug Administration (FDA), Ceruvia Lifesciences has submitted an Investigational New Drug (IND) application to begin a Phase 1 clinical trial of NYPRG-101, a non-hallucinogenic analog of Lysergic acid diethylamide (LSD), being developed for the prevention of migraine.

GREENWICH, Conn., June 21, 2022 /PRNewswire/ — Ceruvia Lifesciences, a leading neurotransformational medicine biopharmaceutical company today announced the submission of an IND application to begin a Phase 1, single center, randomized, double blind, placebo controlled, single ascending dose study to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of NYPRG-101 (2-bromo-D-lysergic acid diethylamide) in healthy adult participants. 

NYPRG-101, also referred to in the literature as BOL-148, is a non-hallucinogenic analog of LSD, differing by only one atom. First synthesized at Sandoz by Albert Hofmann in 1957, BOL-148 was used as a placebo in early LSD trials.  BOL-148 has been administered to more than 150 humans (126 healthy volunteers and 28 patients) in clinical and experimental settings since the 1950s, with most of the research occurring prior to 1970.  In these early studies, BOL-148 was observed to be non-hallucinogenic.

“This is another exciting milestone in the roll-out of our clinical drug development program and builds on our longstanding relationship with Harvard Medical School to investigate the use of BOL-148 to treat headache disorders”, said Carey Turnbull, Founder and CEO of Ceruvia Lifesciences.  “Migraine, which affects approximately 15% of the population and disproportionately impacts women, is associated with significant psychosocial burden and disability.   Results from our IND-enabling pre-clinical toxicology work as well as research conducted with human subjects prior to the 1970s, indicate a positive safety profile for NYPRG-101.  We believe that this molecule has great potential to provide meaningful relief to those suffering from migraine.”

This Phase 1 single ascending dose (SAD) trial, to be held at a single clinical research site in the United States, will evaluate the safety, tolerability, pharmacokinetics and effects on neurocognitive functioning of healthy adult participants. 

About Ceruvia Lifesciences

Founded in 2017, Ceruvia Lifesciences is a clinical-stage biopharmaceutical company with a mission to improve the lives of underserved patients suffering from neurological and psychiatric disorders.  Founded by Carey Turnbull, Ceruvia is relentlessly focused on the development and commercialization of neurotransformational medicines to deliver meaningful relief to patients suffering from hard-to-treat headache disorders, OCD and substance abuse disorder.  For too long, these communities have been poorly understood and under-served. At Ceruvia, we believe they no longer have to live this way.  With a long history of partnership with leading researchers at Yale University School of Medicine, NYU School of Medicine and Harvard Medical School, Ceruvia is undertaking clinical research in order to help them return to living their lives to the fullest. For more information, please visit www.ceruvialifesciences.com

SOURCE Ceruvia Lifesciences

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MAPS under fire for alleged investigator misconduct

MDMA trials under review in Canada over alleged abuse of study participants

Health Canada is reviewing all previously approved MDMA trial applications after a former trial participant came forward with sexual assault allegations.

Footage from MAPS’ PTSD trial in 2015 shows patient Meaghan Buisson being physically restrained and spooned by two therapists (one of them unlicensed) during an MDMA therapy session.

The session was recorded to ensure that therapists were following treatment protocols, but the footage wasn’t actually reviewed for 6 years. MAPS is finally looking into recordings from all past patients.

“I just want people to realize, this is not against MDMA. This is not against psychedelics,” Meaghan ensures.

“I’m just saying that if this drug is going to be legalized and medicalized in this way, then there is a certain degree of safety and fiduciary responsibility and credibility that goes into being part of the medical system — and especially with vulnerable subjects.”

PDF of article 1

PDF of article 2

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How to Change Your Mind comes to Netflix!

How to Change Your Mind | Official Trailer | Netflix

The most famous book on psychedelics becoming a Netflix series this July 12th.

If you haven’t read Michael Pollan’s best-selling book How to Change Your Mind, you’re missing out. The book provides one of the most comprehensive summaries on the history and future of psychedelic research, covering so many fascinating details that we could never fit in this 5-minute newsletter.

Now, the book is being transformed into a 4 part docu-series on the healing potential of LSD, psilocybin, MDMA, and mescaline. The 

The psychedelics sector gained a ton of traction after the documentary Fantastic Fungi was released — we can only imagine the positive impact this series will have!

Watch the official trailer

Buy the book