Posted on

PharmAla Biotech Supports Decision to Decriminalize Possession of MDMA in British Columbia

PharmAla Biotech Supports Decision to Decriminalize Possession of MDMA in British Columbia

The Decision, taken by Health Canada, to decriminalize possession of MDMA under 2.5g, comes pursuant to a request from the Government of British Columbia

VANCOUVER, BC, June 2, 2022 /CNW/ – PharmAla Biotech (CSE: MDMA) strongly endorses the decision by the Government of Canada to decriminalize possession of 2.5g or less of MDMA in the province of British Columbia.

“This decision is critically important. As a company focused on the manufacturing of legal MDMA for clinical research, we strongly believe that MDMA is safe for human use, and of medical benefit if taken as part of a treatment regimen,” said Jodi Butts, Board Chair of PharmAla Biotech. “While more work needs to be done, we are happy to see the Government of Canada take this historic action in British Columbia.”

PharmAla Biotech is the only manufacturer of MDMA for clinical use in North America. It does not engage with, nor will it benefit in any way, from the decision taken by the Governments of British Columbia and Canada over the possession of illicit MDMA.

“MDMA does not fit the profile of a Schedule I narcotic. It is, generally speaking, well-tolerated. However, the threat of illegal supply and toxic contaminants is a serious public health risk,” said Nick Kadysh, PharmAla’s CEO. “PharmAla developed the only MDMA manufacturing value chain in North America in order to provide clinical researchers with the supplies they need to complete valuable scientific research – and our own research into novel MDMA analogs will heighten the safety profile of this molecule, so it can be used as a medicine.”

ABOUT PHARMALA

PharmAla Biotech Holdings Inc. (CSE: MDMA) is a biotechnology company focused on the research, development, and manufacturing of MDXX class molecules, including MDMA. PharmAla was founded with a dual focus: alleviating the global backlog of generic, clinical-grade MDMA to enable clinical trials, and to develop novel drugs in the same class. PharmAla is a “regulatory first” organization, formed under the principle that true success in the psychedelics industry will only be achieved through excellent relationships with regulators. Our team of dedicated professionals includes regulatory experts, scientists, and biomanufacturing professionals. PharmAla has built what it believes to be North America’s first cGMP MDMA value chain, encompassing GMP manufacturing of Active Pharmaceutical Ingredient (API), and drug product formulation. PharmAla’s research and development unit has also begun preclinical research into two patented Novel Chemical Entities (NCEs) based on MDXX class molecules, with proof-of-concept research currently ongoing at the University of Arkansas Medical School.

Posted on

Nirvana Life Sciences Announces Positive Results for Addiction Relapse Prevention from Their Latest Pre-Clinical Psychedelic Drug Study

Nirvana Life Sciences Announces Positive Results for Addiction Relapse Prevention from Their Latest Pre-Clinical Psychedelic Drug Study

Psilocybin reduced reinstatement of heroin-seeking behavior when administered immediately after a memory retrieval task in rats

Vancouver, British Columbia–(Newsfile Corp. – June 2, 2022) – Nirvana Life Sciences Inc. (CSE: NIRV) (Nirvana or the “Company”), a Canadian-based life sciences company focused on developing novel therapeutic products derived from psychedelics to produce non-addictive solutions for opioid addiction treatment and ongoing pain management, in conjunction with Integrative Therapy Discovery (ITD) Labs in Italy, have released comprehensive data on a scientific study that aims in determining the effects that psilocybin has on the heroin-addicted brain.

The study was carried out by Dr. Massimo Nabissi from the School of Pharmacy Section of Experimental Medicine, University of Camerino in Camerino, Italy. The preclinical study evaluated the effect of psilocybin on in-vitro rat brain cell line models and an in-vivo rat model on heroin self-administration and reinstatement of heroin seeking behavior following memory retrieval tests. Drug self-administration is regarded as a gold-standard preclinical model of addiction and substance-use disorders. The aim of the project was threefold and are as follows.

  • To evaluate the effect of psilocybin in modulating heroin molecular pathways in in vitro rat brain cell line models
  • To evaluate the effect of psilocybin on heroin self-administration (in vivo results)
  • To evaluate the effect of psilocybin on reinstatement of heroin seeking following memory retrieval test (in vivo results)

Gene Analysis was performed by the Clariom S Assay tool. This machine serves as a next generation transcriptome-wide gene-level expression profiling tool, which allows for the fastest, simplest and most scalable path to generating actionable results. Based on industry-leading microarray technology, the novel rat Clariom S Assay provides extensive coverage of all known well-annotated genes, compatibility with clinical sample types, scalable formats, and flexible data analysis software. The GeneChip™ Rat Genome 230 2.0 Assay was used to evaluate gene expression levels and in cell lines that were treated with heroin and psilocybin and with psilocybin in combination with heroin.

The immortalized rat hypothalamus cells (RCHT-1) were derived from the hypothalamus of a four-month-old Fisher Rat. The hippocampal cells (H19-7) derived from the rats’ hippocampi were treated daily with heroin and psilocybin, alone or in combination. After 48 hours, cell lines were collected for RNA extraction and gene array analysis. For each of the comparisons indicated, an electronic file was created that includes differentially expressed transcripts that were identified in both H19-7 and RCTH-1 cells with extended annotations. A second file was created that made comparisons evidencing only the transcript differences where the Ct (or cell type) value was highly different as a final analysis. For each of these data sets, only the genes whose expression was reverted by psilocybin and in the treatments consisting of heroin plus psilocybin were selected. Moreover, only the genes whose expression was psilocybin dose dependent were considered. In summary, the potential candidate genes whose expression in heroin treatment was reverted by psilocybin and evidenced in the electronic file reports were selected.

The effect of heroin and psilocybin in reducing cell viability was evaluated in HT19-7 and RCHT-1 cell lines by daily administration. Cells were treated for 48 hours with either heroin or psilocybin or with a combination of heroin with psilocybin and then were analyzed. The percentage of cell viability was evaluated by a cell viability assay whose results showed a dose-dependent heroin effect in the RCHT-1 cell line with specific IC50 values. While in HT19-7 cell lines, no cytotoxic effects were observed at the concentrations used. Regarding psilocybin, similar results were obtained in cell lines with specific IC50 values and with both RCHT-1 and HT19-7 cell lines. To gain further insight, heroin was combined with psilocybin at varying doses to evaluate the optimal combination for transcriptional study. The results showed that when used together at varying dosages, the combinations were not cytotoxic in either of the two cell lines.

The study goes on to show how treatment with psilocybin effected self-administered heroin use via lever presses along with the overall effect that psilocybin combined with heroin had on certain behavioral models in both male and female Wistar rat populations. A preliminary experiment aimed at testing the efficacy of psilocybin to prevent heroin relapse following cue memory reconsolidation was also conducted. Altogether, these results suggest that psilocybin decreased reinstatement of heroin seeking in female rats. As a final analysis, the gene data evidenced in the study was subjected to a comprehensive academic wide search of available current littérature and, although information regarding a correlation with psilocybin and opioid addiction was available, a transcriptome analysis for heroin and psilocybin and their co-combination has never been previously investigated. As a result, the data presented in this study can be extremely useful for determining a better understanding of dependent doses and the molecular mechanisms involved in the potential modulation of heroin (or opioids in general) addiction and dependence.

In summary, the information contained within the study dealing with relapse prevention is new and groundbreaking evidence in the field of pharmaceutical addictions medicine and chemotherapy. This type of comprehensive study, which constitutes concrete scientific evidence-based data, is at the heart of Nirvana Life Sciences’ business objective which is to develop and seek FDA approval for therapeutic formulations and novel pharmaceuticals.

Dr. Sazzad Hossain, CSO of Nirvana, states, “Our research team has over 100 years of combined academic and applied experience in the field of psychedelic science. I’m excited to see what they can do with this new information.”

About Nirvana Life Sciences Inc.

Nirvana Life Sciences Inc. has been founded with a simple objective of researching and developing non-addictive pain management and relapse prevention products that can provide healthier outcomes for patients who live with chronic pain and/or have battled with addiction. Nirvana believes that using naturally sourced psychedelics in novel formulations holds the promise of delivering non-addictive solutions that are effective in managing pain and addiction. Nirvana’s team, consisting of leading researchers from around the globe, will develop therapies that have the potential of freeing millions from addiction and saving society billions of dollars annually.

For further information:

Bruce Clark- CEO
info@nirvanalifescience.com
Phone: 604-401-8100

Forward-Looking Statements

This news release contains certain forward-looking statements and forward-looking information (collectively referred to herein as “forward- looking statements”) within the meaning of Canadian securities laws including, without limitation, statements with respect to the future investments by the Company. All statements other than statements of historical fact are forward-looking statements. Undue reliance should not be placed on forward-looking statements, which are inherently uncertain, are based on estimates and assumptions, and are subject to known and unknown risks and uncertainties (both general and specific) that contribute to the possibility that the future events or circumstances contemplated by the forward-looking statements will not occur. Although the Company believes that the expectations reflected in the forward-looking statements contained in this press release, and the assumptions on which such forward-looking statements are made, are reasonable, there can be no assurance that such expectations will prove to be correct. Readers are cautioned not to place undue reliance on forward-looking statements included in this document, as there can be no assurance that the plans, intentions or expectations upon which the forward-looking statements are based will occur. By their nature, forward-looking statements involve numerous assumptions, known and unknown risks and uncertainties that contribute to the possibility that the predictions, forecasts, projections and other forward-looking statements will not occur, which may cause the Company’s actual performance and results in future periods to differ materially from any estimates or projections of future performance or results expressed or implied by such forward-looking statements. The forward-looking statements contained in this news release are made as of the date hereof and the Company does not undertake any obligation to update publicly or to revise any of the included forward-looking statements, except as required by applicable law. The forward-looking statements contained herein are expressly qualified by this cautionary statement.

Posted on

Novamind Announces New Patient Financing Options

Novamind Announces New Patient Financing Options

TORONTO, ON / June 2, 2022 / Novamind Inc. (CSE: NM | OTCQB: NVMDF | FSE: HN2)(“Novamind” or the “Company”), a leading mental health company specialized in psychedelic medicine, today announced new patient financing options to help patients access critical mental healthcare services at its six clinic locations in Utah. The Company now accepts Synchrony’s CareCredit credit card for treatments including Transcranial Magnetic Stimulation (TMS), ketamine therapy and Spravato therapy.

Affordability of mental healthcare services remains a primary barrier to accessing treatment in the U.S. In a 2021 survey from McKinsey & Company, almost one fourth of respondents reported deferring mental healthcare, with lack of affordable treatment ranking as the top reason why.1

“Novamind is committed to ensuring that as many patients as possible can access mental health treatment,” said Seneca Anderson, SVP Operations. “Further to delivering the highest standard of care in a variety of accessible formats, whether it’s virtual, in-person, one-on-one or in groups, we’re pleased to implement additional flexible patient financing options like CareCredit at our clinics to reduce barriers to care.”

CareCredit enables patients with a quick prequalifying process and applications via mobile device or over the phone, resulting in an instant credit decision. Once approved, patients can immediately use the CareCredit credit card to pay for deductibles, copays and coinsurance, as well as other costs not covered by insurance.

To learn more, please visit www.cedarpsychiatry.com/insurance.

About Novamind
Novamind is a leading mental health company enabling safe access to psychedelic medicine through a network of clinics and clinical research sites. Novamind provides ketamine-assisted psychotherapy and other novel treatments through its network of integrative mental health clinics and operates a full-service contract research organization specialized in clinical trials and evidence-based research for psychedelic medicine. For more information on how Novamind is enhancing mental wellness and guiding people through their entire healing journey, visit novamind.ca.

Contact Information
Yaron Conforti, CEO and Director
Telephone: +1 (647) 953 9512

Samantha DeLenardo, VP, Communications
Email: media@novamind.ca

Investor Relations
Email: IR@novamind.ca

Forward-Looking Statements
This news release contains forward-looking statements. All statements other than statements of historical fact included in this release are forward-looking statements that involve risks and uncertainties. There can be no assurance that such statements will prove to be accurate and actual results and future events could differ materially from those anticipated in such statements. Important factors that could cause actual results to differ materially from the Company’s expectations including the risks detailed from time to time in the Company’s public disclosure. The reader is cautioned not to place undue reliance on any forward-looking information. Forward-looking statements contained in this news release are expressly qualified by this cautionary statement. The forward-looking statements contained in this news release are made as of the date of this news release and the Company will update or revise publicly any of the included forward-looking statements as expressly required by applicable laws.

1: https://www.mckinsey.com/industries/healthcare-systems-and-services/our-insights/how-affordable-is-mental-healthcare-the-long-term-impact-on-financial-health

Posted on

Psyence Group Corporate Update

Psyence Group Corporate Update

Highlights:

  • Partnership with CRO Clerkenwell Health to design and deliver Psyence’s UK clinical trial progressing; exclusive licensing agreement with Filament Health
  • Clive Ward-Able has been appointed as Medical Director, Head of Research & Development and Early Commercialization for Psyence
  • ISO22000 certified commercial psilocybin production facility and lab upgraded
  • Received an import permit from Health Canada on behalf of Psilo Scientific
  • GOODMINDTM, functional mushroom product, launched online and in-store, sale through 300 stores of one of Africa’s largest coffee retail chains
  • CAD 1.273 million private placement received and being closed
  • Exploring capital market initiatives in UK, hires Investment Bank

TORONTO, ON/ June 02, 2022 / Psyence Group Inc. (CSE: PSYG | OTCQB: PSYGF) (“Psyence” or the “Company”) is pleased to provide the following corporate update on its three strategic focus areas namely: Psyence Therapeutics, Psyence Production and Psyence Function. The Psyence Group develops and provides innovative, safe, and effective psychedelic and nature-centered solutions for mental health and palliative care.

Psyence Therapeutics

Psyence is designing market-leading clinical trials in the field of palliative care, which will initially be conducted in the United Kingdom.

Psyence has partnered with a leading psychedelic Contract Research Organisation (CRO) Clerkenwell Health, to design and deliver the clinical trial, focused on assessing the safety and efficacy of psilocybin-assisted psychotherapy for the treatment of adjustment disorder due to an incurable cancer diagnosis versus psychotherapy alone.

The UK’s “Guardian Online” reported on May 9, 2022 that Clerkenwell Health “hopes to “make the UK a world leader in psychedelics research and Europe’s first facility for psychedelic drug trials will open in London”. The article noted that “the first trials, planned in collaboration with the Toronto-based biotechnology company Psyence, will focus on the use of psilocybin for the treatment of adjustment disorder – an emotional or behavioural reaction to a stressful event in someone’s life – in people with terminal diagnoses.”

Psyence recently concluded an exclusive licensing agreement with Filament Health Corp, a clinical-stage natural psychedelic drug development company, in April 2022. Filament has previously received authorisation from the FDA and Health Canada to enter into Phase I and Phase II human clinical trials for this drug candidate, PEX010. Under the terms of the agreement, Filament will license its proprietary botanical drug candidate PEX010 (25mg), and the associated intellectual property, to Psyence for use in Psyence’s upcoming clinical trials. The license grants Psyence exclusivity in the UK for the indications of anxiety and depression, and associated ailments, within the context of palliative care.

In addition, Psyence appointed Dr. Clive Ward-Able as Medical Director, Head of Research & Development and Early Commercialization for Psyence in December 2021. Based in Toronto Canada, Dr. Ward-Able has degrees in both Pharmacy and Medicine and over thirty years’ experience in the pharmaceutical industry, within R&D, medical affairs, marketing and sales. The majority of his experience is in the medical aspects of the commercialization of a pharmaceutical product, with expertise and direct involvement in designing and conducting clinical trials.

The Psyence Therapeutics team also contributes to scientific research; Psyence’s Dr. Amza Ali, MD,  (Chief Medical Officer) and Dr. Justin Grant, PhD, MBA, (Chief Scientific Officer) co-authored the peer-reviewed publication “Psychedelics: Alternative and Potential Therapeutic Options for Treating Mood and Anxiety Disorders,” which was published in the journal “Molecules” April 19, 2022.

Psyence Production

Psyence operates one of the first and only federally licensed commercial psilocybin production facilities in the world. Its production facility, located in Southern Africa, is ISO22000 certified and is licensed to cultivate and export psilocybin mushrooms for the legal, global medical market and commercial medical research market.

In March 2022 Psyence received an import permit from Health Canada on behalf of Psilo Scientific and is preparing to send mushrooms to Canada for analysis and extraction. Psyence has also received an import permit from the Portuguese regulators for the Cooperativa de Ensino Superior Politécnico e Universitário (CESPU) in Portugal and will be providing mushrooms for their extraction methodology development. Psyence is in the process of obtaining the necessary permissions to commence with the export process to these partners.

Psyence has recently concluded an upgrade to its production facility. A new structure has expanded the overall controlled workspace and further secures the facility. The structure also serves to protect the current assets including the spore and substrate unit, laboratory and fruiting facility. The covering will help Psyence decrease its energy costs through providing better insulation. It has been designed to enable a more flexible and cost -effective expansion of the facility in the future to match the expected growth in demand for natural psilocybin.

The laboratory has also been expanded as part of this upgrade. This expansion enables Psyence to have the capability and equipment to undertake in-process testing on site, as well as to generate Certificates of Analysis (COAs) and undertake testing of the end product. It also provides the space for Psyence to undertake crude extraction and testing at the facility. Our extraction partners will then process the crude extract into an active pharmaceutical ingredient (API). There are multiple benefits to on-site extraction including increased product shelf life and reduced transport costs. Psyence mycologist, Neil Van Rij, and his Quality Assurance team are currently receiving training on the new equipment and expect to be fully functional by the end of June 2022.

Psyence Function

Psyence Function is focused on the development, distribution and sales of legal over-the-counter non-psilocybin containing functional mushroom nutraceuticals.

Psyence’s first non-psilocybin containing functional mushroom product, GOODMINDTM was launched online in 2021 through its South African based joint venture, Good Psyence. Good Psyence launched the GOODMINDTM product on the digital platform http://www.foragoodmind.com that was registered and developed by Psyence’s joint venture partner, Goodleaf, solely for the sale of such products. GOODMINDTM is also distributed through the digital platforms of Goodleaf, Takealot (South Africa’s leading online retailer) and Wellness Warehouse online as well as Wellness Warehouse stores. Wellness Warehouse is a leading distributor and retailer of natural and organic products in South Africa. GOODMINDTM’s water-soluble functional mushroom sachets, which blend with coffee and other beverages, are available for sale through 300 stores of one of Africa’s largest coffee retail chains, Vida e Caffè.

Corporate Update

The Company is pleased to announce that the non-brokered private placement as announced on December 2, 2021 has yielded approximately CAD 1.273 million of subscriptions and is in the process of closing.

The Company has identified the UK as an investor market for mental wellness and has engaged Hannam & Partners as Corporate Advisors in the UK to assist in exploring capital market opportunities to access a broader pool of UK and European investors.  Hannam & Partners, our Corporate Advisors, are also working with Psyence to investigate a potential dual listing in the UK. As part of this dual listing exercise the Company conducted a thorough legal exercise.  The Company obtained legal opinions from local counsel registered in each jurisdiction in which the Company currently operates for the purpose of confirming the lawfulness of the Company’s activities currently carried on in each jurisdiction.  Each local legal adviser was required to address their legal opinion to UK legal counsel (having significant experience in proceeds of crime and anti-money laundering offences), for the purpose of confirming that such activities are suitable for investment by UK persons and such investment would be unlikely to amount to an offence in England under the Proceeds of Crime Act 2002 and relevant anti-money laundering legislation.  Based upon the legal opinions obtained, including the opinion of UK legal counsel, the directors of the Company are satisfied that the current activities of the Group do not pose such a risk.

In light of the challenging small cap and global equity markets as a whole, the Company has put into place cash preservation strategies to reduce operational expenditure across the business, including executive remuneration reductions and accruals.

 “Psyence’s progress continues to strengthen our company’s focused strategy,” says Dr. Neil Maresky, Psyence Chief Executive Officer. “As we execute on our plans as detailed in this corporate update, and continue to focus on operational efficiencies, we believe Psyence will achieve its milestones and in doing so deliver shareholder value.”

ABOUT PSYENCE GROUP: www.psyence.com

Psyence is a life science biotechnology company listed on the Canadian Securities Exchange (CSE: PSYG) and quoted on the OTCQB (OTCQB: PSYGF), with a focus on natural psychedelics. Psyence works with natural psilocybin products for the healing of psychological trauma and its mental health consequences in the context of palliative care. Our name “Psyence” combines the words psychedelic and science to affirm our commitment to producing psychedelic medicines developed through evidence-based research.

Informed by nature and guided by science, we built and operate one of the world’s first federally licensed commercial psilocybin mushroom cultivation and production facilities in Southern Africa. Our team brings international experience in both business and science and includes experts in mycology, neurology, palliative care, and drug development.  We work to develop advanced natural psilocybin products for clinical research and development.

Our key divisions, Psyence Production, Psyence Therapeutics and Psyence Function, anchor an international collaboration, with operations in Canada, the United Kingdom, Southern Africa, and a presence in the United States and Australia.

Contact Information

Katherine Murphy, Investor Relations
Email: ir@psyence.com
Media Inquiries: media@psyence.com
General Information: info@psyence.com

FORWARD LOOKING STATEMENTS:

Certain statements in this news release related to Psyence Group Inc and its subsidiaries (collectively 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 the approval of clinical trial applications by the relevant regulatory authorities, the receipt of all regulatory approvals for the Company’s import and export activities, the appetite for investment into the psychedelic and mental wellness sector by UK and European investors, the fulfilment of the conditions required to achieve Company milestones, the effectiveness of the Company’s operational efficiency measures and the resultant creation of shareholder value. These forward-looking statements are based on a number of assumptions, including the assumptions that the Company’s applications will be successful, the Company’s research and development efforts will yield favourable results sufficient for product commercialisation and that there will be demand in the market for the Company’s current product offering internationally. There are numerous risks and uncertainties that could cause actual results and the Company’s plans and objectives to differ materially from those expressed in the forward-looking information. These risks and uncertainties include demand for the Company’s securities being less than anticipated, fluctuations in the price the Company’s common shares, and the Company not raising the amount expected, or any funds at all. Actual results and future events could differ materially from those anticipated in such information. These and all subsequent written and oral forward-looking information are based on estimates and opinions of management on the dates they are made and are expressly qualified in their entirety by this notice. Except as required by law, the Company does not intend to update these forward-looking statements.

The Company makes no medical, treatment or health benefit claims about the Company’s proposed products. The U.S. Food and Drug Administration, Health Canada or other similar regulatory authorities have not evaluated claims regarding psilocybin, psilocybin analogues, 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, psilocybin analogues, or other psychedelic compounds or nutraceuticals can diagnose, treat, cure or prevent any disease or condition. Vigorous scientific research and clinical trials are needed. The Company 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 the Company verified such in clinical trials or that the Company will complete such trials. If the Company cannot obtain the approvals or research necessary to commercialize its business, it may have a material adverse effect on the Company’s performance and operations.

Posted on

Relmada Therapeutics to Participate in the 2022 Jefferies Global Healthcare Conference

Relmada Therapeutics to Participate in the 2022 Jefferies Global Healthcare Conference

June 02, 2022 8:30am EDT

CORAL GABLES, Fla., June 2, 2022 /PRNewswire/ — Relmada Therapeutics, Inc. (NASDAQ: RLMD), a late-stage biotechnology company addressing diseases of the central nervous system (CNS), today announced that Sergio Traversa, Chief Executive Officer, and Maged Shenouda, Chief Financial Officer, will participate in a fireside chat at the 2022 Jefferies Global Healthcare Conference on Wednesday, June 8, 2022, at 4:00pm ET. Please find additional details about the event below.

2022 Jefferies Global Healthcare Conference
Date: Wednesday, June 8, 2022, 4:00-4:25pm ET
Webcast: https://wsw.com/webcast/jeff240/rlmd/1845375

The webcast can also be accessed in the Investors section of the Relmada website at https://www.relmada.com/investors/ir-calendar. An archived replay will be available for 90 days after the conclusion of the event.

About REL-1017

REL-1017, a new chemical entity (NCE) and novel NMDA receptor (NMDAR) channel blocker that preferentially targets hyperactive channels while maintaining physiological glutamatergic neurotransmission, is currently in late-stage development for the treatment of major depressive disorder (MDD). The ongoing Reliance Clinical Research Program is designed to evaluate the potential for REL-1017 as a rapid-acting, oral, once-daily antidepressant treatment. In a Phase 2 trial, REL-1017 demonstrated rapid, robust, and sustained antidepressant effects with statistically significant improvements compared to placebo. The Phase 2 study also showed a favorable pharmacokinetic, safety, and tolerability profile of REL-1017 consistent with results observed in previously completed Phase 1 studies.

About Relmada Therapeutics, Inc.

Relmada Therapeutics is a late-stage biotechnology company addressing diseases of the central nervous system (CNS), with focus on major depressive disorder (MDD). Relmada’s experienced and dedicated team is committed to making a difference in the lives of patients and their families. Relmada’s lead program, REL-1017, is a new chemical entity (NCE) and novel NMDA receptor (NMDAR) channel blocker that preferentially targets hyperactive channels while maintaining physiological glutamatergic neurotransmission. REL-1017 has entered late-stage development as an adjunctive and monotherapy treatment for MDD. In addition, Relmada is advancing a clinical-stage program in neurodegenerative diseases based on psilocybin and select derivative molecules. Learn more at www.relmada.com.

Forward-Looking Statements

The Private Securities Litigation Reform Act of 1995 provides a safe harbor for forward-looking statements made by us or on our behalf. This press release contains statements which constitute “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Any statement that is not historical in nature is a forward-looking statement and may be identified by the use of words and phrases such as “expects,” “anticipates,” “believes,” “will,” “will likely result,” “will continue,” “plans to,” “potential,” “promising,” and similar expressions. These statements are based on management’s current expectations and beliefs and are subject to a number of risks, uncertainties and assumptions that could cause actual results to differ materially from those described in the forward-looking statements, including the risk factors described under the heading “Risk Factors” set forth in the Company’s reports filed with the SEC from time to time. No forward-looking statement can be guaranteed, and actual results may differ materially from those projected. Relmada undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise. Readers are cautioned that it is not possible to predict or identify all the risks, uncertainties and other factors that may affect future results and that the risks described herein should not be a complete list.

Investor Contact:
Tim McCarthy
LifeSci Advisors
212-915-2564
tim@lifesciadvisors.com 

Media Inquiries:
FischTank PR
relmada@fischtankpr.com 

Cision View original content to download multimedia:https://www.prnewswire.com/news-releases/relmada-therapeutics-to-participate-in-the-2022-jefferies-global-healthcare-conference-301560088.html

SOURCE Relmada Therapeutics, Inc.

Released June 2, 2022

Posted on

Awakn Life Sciences Initiates Follow-on Behavioral Study to Focus on Gambling Disorder

Awakn Life Sciences Initiates Follow-on Behavioral Study to Focus on Gambling Disorder

Study Initiated Following Recent Successful Pilot Study and Patent Filing

TORONTO, CANADA, June 2, 2022 – Awakn Life Sciences Corp. (NEO: AWKN, OTCQB: AWKNF, FSE: 954) (‘Awakn’), a biotechnology company, researching, developing, and commercializing therapeutics to treat addiction with a near-term focus on Alcohol Use Disorder (AUD), announced today that they have initiated a larger behavioral addiction study investigating ketamine as a treatment for Gambling Disorder. Awakn announced on May 19, 2022, that the Company had completed a successful pilot study for a range of behavioral addictions. On May 26, 2022, Awakn announced the filing of a Patent Cooperation Treaty (PCT) for the treatment of behavioral addictions with ketamine and ketamine-assisted psychotherapy.

The larger study announced today will include 42 patients who are suffering from Gambling Disorder and will see participants undergo a memory reactivation procedure, which is designed to weaken the link between reward and addiction memories. The larger placebo-controlled study will be the first investigation globally to explore this technique to treat Gambling Disorder.

The study will use advanced brain imaging technology EEG (Electro Encephalography) and will index the synaptic plasticity post-ketamine administration with the aim of identifying the window of greatest neuroplastic change. This would potentially allow Awakn to predict when therapy will be at its most effective due to the neuroplasticity. The study will also collect detailed pharmacokinetic (PK) data and analyze metabolites as well as examining neurological biomarkers. 

Awakn CEO Anthony Tennyson commented, “Awakn is dedicated to helping people who are suffering from addiction, and we are greatly enthused by the significant research & development milestones we have passed in recent weeks.  None of this would be possible without the dedication of the Awakn team and I would like to formally thank them, and everyone involved, including patients, physicians, and carers.”

Gambling Disorder affects up to 450 million[1] people globally. In the US alone, it is estimated that more than 2.5% of the population suffer from Gambling Disorder, that is over 8 million people2. With no pharmacological treatments currently available, the need to find an effective treatment has never been more acute.

About Awakn Life Sciences Corp.

Awakn Life Sciences is a biotechnology company, researching, developing and commercializing combined therapeutics to treat addiction, with a focus on Alcohol Use Disorder.  Awakn’s team consists of renowned research experts, world leading chemists, scientists, psychiatrists, and psychologists. Addiction is one of the biggest unmet medical needs of our time, affecting over 20% of the global population and is an industry valued at over $100bn per annum. Awakn is working to disrupt this underperforming industry by advancing the next generation of drugs and therapies to be used in combination, through preclinical research and clinical-stage trials.

www.awaknlifesciences.com  |  Twitter  |  LinkedIn  |  Facebook

Notice Regarding Forward-Looking Information

This news release contains certain forward-looking information and forward-looking statements, as defined in applicable securities laws (collectively referred to herein as “forward-looking statements”). Forward-looking statements reflect current expectations or beliefs regarding future events or the Company’s future performance. All statements other than statements of historical fact are forward-looking statements. Often, but not always, forward-looking statements can be identified by the use of words such as “plans”, “expects”, “is expected”, “budget”, “scheduled”, “estimates”, “continues”, “forecasts”, “projects”, “predicts”, “intends”, “anticipates”, “targets” or “believes”, or variations of, or the negatives of, such words and phrases or state that certain actions, events or results “may”, “could”, ”would”, “should”, “might” or “will” be taken, occur or be achieved, including statements relating the business of the Company. All forward-looking statements, including those herein are qualified by this cautionary statement.

Although the Company believes that the expectations expressed in such statements are based on reasonable assumptions, such statements are not guarantees of future performance and actual results or developments may differ materially from those in the statements. There are certain factors that could cause actual results to differ materially from those in the forward-looking information. These include, but are not limited to: COVID-19; fluctuations in general macroeconomic conditions; the business plans and strategies of the Company; the ability of the Company to comply with all applicable governmental regulations in a highly regulated business; the inherent risks in investing in target companies or projects which have limited or no operating history and are engaged in activities currently considered illegal in some jurisdictions; changes in laws; limited operating history; reliance on management; requirements for additional financing; competition; fluctuations in securities markets; inconsistent public opinion and perception regarding the medical-use of psychedelic drugs; expectations regarding the size of the addiction market; and regulatory or political change. Readers are cautioned that the foregoing list of factors is not exhaustive of the factors that may affect forward-looking statements. Accordingly, readers should not place undue reliance on forward-looking statements. The forward-looking statements in this news release speak only as of the date of this news release or as of the date or dates specified in such statements.

Investors are cautioned that any such statements are not guarantees of future performance and actual results or developments may differ materially from those projected in the forward-looking information. For more information on the Company, investors are encouraged to review the Company’s public filings on SEDAR at www.sedar.com. The Company disclaims any intention or obligation to update or revise any forward- looking information, whether as a result of new information, future events or otherwise, other than as required by law.

This news release does not constitute an offer to sell, or a solicitation of an offer to buy, any securities in the United States. The Company’s and Awakn’s securities have not been and will not be registered under the United States Securities Act of 1933, as amended (the “U.S. Securities Act”) or any state securities laws and may not be offered or sold within the United States or to U.S. Persons unless registered under the U.S. Securities Act and applicable state securities laws or an exemption from such registration is available.

Investor Enquiries:
Anthony Tennyson, CEO, Awakn Life Sciences
anthony.tennyson@awaknlifesciences.com

Media Enquiries:
America and Canada: KCSA Strategic Communications 
Anne Donohoe
Adonohoe@KCSA.com

Rest of World: ROAD Communications
Paul Jarman / Nora Popova
Awakn@roadcommunications.co.uk

[1]: Problem gambling worldwide: An update and systematic review of empirical research (2000–2015):

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5370365

2: North American Foundation for Gambling Addiction Help:

https://nafgah.org/statistics-gambling-addiction-2016/

Posted on

Braxia Scientific Presents Positive Preliminary Findings from Phase II Randomized, Multi-Dose Clinical Trial of Psilocybin-Assisted Therapy for Treatment Resistant Depression

Braxia Scientific Presents Positive Preliminary Findings from Phase II Randomized, Multi-Dose Clinical Trial of Psilocybin-Assisted Therapy for Treatment Resistant Depression

TORONTO, June 2, 2022 / Braxia Scientific Corp. (“Braxia Scientific”, or the “Company”), (CSE: BRAX) (OTC: BRAXF) (FWB: 4960), a medical research company with clinics providing and advancing innovative ketamine and psilocybin treatments for depression and related mental health disorders, is pleased to announce positive preliminary results from the first Health Canada Approved, Phase II, randomized clinical trial to evaluate the feasibility, safety, tolerability, and efficacy of multi-dose psilocybin-assisted therapy for Treatment-Resistant-Depression. The preliminary results were presented at the “From Research to Reality Conference” in Toronto, May 27-28, 2022.

Positive Preliminary Results Highlights

Braxia Scientific’s ongoing multi-dose psilocybin trial effectively demonstrated the feasibility of Braxia’s proprietary psilocybin-assisted therapy protocol with high rates of recruitment and retention with adequate tolerability and safety.
Clinically meaningful improvements in depression severity observed (as measured by the MADRS1) with complete analysis of antidepressant efficacy and secondary outcomes pending. This trial will be completed by December 2022 at which point the full analysis will be completed and submitted for publication.
Preliminary results indicate strong feasibility with adequate recruitment including 159 individuals who were referred to the study.
Retention – 93% of participants retained to primary endpoint.
Safety – No serious adverse events and zero suicide attempts to date.
Tolerability – majority of adverse effects resolving within 24 hours of each dose and 87% of participants requesting to receive a second dose.
Feasibility of Braxia Institute psychedelic therapy training program demonstrated through recruiting, retaining, and training group of multi-disciplinary independently licensed therapists that continue to serve as therapists as part of Braxia’s psilocybin trial. Group of therapists consists of psychiatrists, primary care therapists, psychotherapists and spiritual care.
(1) Symptoms of depression were assessed using the Montgomery-Åsberg depression rating scale (MADRS), a widely used and accepted scale for assessing depression.

“These results clearly show that we have the infrastructure, expertise and personnel to effectively and safely provide psilocybin-assisted therapy. Dr. Joshua Rosenblat, Chief Medical and Scientific Officer, Braxia Scientific, and Principal Investigator. “While these preliminary results are highly encouraging, they also provide us with additional guidance as we evaluate and optimize our clinical protocols in delivering innovative, psychedelic treatments to patients with treatment resistant depression. These results also reinforce the potential value of the clinical infrastructure we have established to target new innovative treatments.”

Dr. Roger McIntyre, President and CEO, Braxia Scientific, “In addition to our ongoing trial that enables us to provide access to this treatment today, we are excited by the prospect these results with psilocybin may offer patients with treatment resistant depression, an area in need of therapeutic innovation. In addition to guiding professionals internationally on the safe and effective implementation of ketamine, Braxia Scientific is also conducting highly rigorous clinical research with psilocybin, ketamine, and related agents with the aim to provide eligible persons with innovative treatments that work rapidly and are safe to administer.”

Accessing Psilocybin and Ketamine in Canada

Braxia Scientific is a leader in providing access to innovative rapid acting treatments such as ketamine and psilocybin for people living with treatment resistant depression. Braxia Scientific was the first to receive Health Canada approval for a multi-dose psilocybin-assisted therapy clinical trial in July 2021, and dosed its first participant in November 2021. This ongoing clinical trial provides Canadians with immediate access to psilocybin for treatment resistant depression.

Recently, Braxia Scientific also recently announced its among the first to receive approval for psilocybin-assisted therapy treatment approval in Ontario using Health Canada’s Special Access Program (SAP). The SAP was amended January 5th, 2022 to include access to psychedelic compounds on a case-by-case basis outside of clinical trials.

Canadians interested in applying to the SAP, to participate in clinical trials or to qualify for other treatments, such as IV and oral Ketamine for the treatment of depression, may contact the medical team at Braxia Health (the Canadian Rapid Treatment Centre of Excellence https://crtce.com).

About Braxia Scientific Corp.

Braxia Scientific is a medical research company with clinics that provide innovative ketamine treatments for persons with depression and related disorders. Through its medical solutions, Braxia aims to reduce the illness burden of brain-based disorders, such as major depressive disorder among others. Braxia is primarily focused on (i) owning and operating multidisciplinary clinics, providing treatment for mental health disorders, and (ii) research activities related to discovering and commercializing novel drugs and delivery methods. Braxia seeks to develop ketamine and derivatives and other psychedelic products from its IP development platform. Through its wholly owned subsidiary, the Canadian Rapid Treatment Center of Excellence Inc., Braxia currently operates multidisciplinary community-based clinics offering rapid-acting treatments for depression located in Mississauga, Toronto, Ottawa, and Montreal.

ON BEHALF OF THE BOARD

“Dr. Roger S. McIntyre”

Dr. Roger S. McIntyre

Chairman & CEO

FOR FURTHER INFORMATION PLEASE CONTACT:

Braxia Scientific Corp.

Tel: 416-762-2138

Email: info@braxiascientific.com

Website: www.braxiascientific.com

The CSE has not reviewed and does not accept responsibility for the accuracy or adequacy of this release.

Forward-looking Information Cautionary Statement

This news release contains forward-looking statements within the meaning of applicable securities laws. All statements that are not historical facts, future estimates, plans, programs, forecasts, projections, objectives, assumptions, expectations, or beliefs of future performance are “forward-looking statements.”

Forward-looking statements include statements about the intended promise of ketamine-based treatments for depression and the potential for ketamine to treat other emerging psychiatric disorders, such as Bipolar Depression. Such forward- looking statements involve known and unknown risks, uncertainties and other factors that may cause actual results, events, or developments to be materially different from any future results, events or developments expressed or implied by such forward-looking statements. Such risks and uncertainties include, among others, the failure of ketamine, psilocybin and other psychedelics to provide the expected health benefits and unanticipated side effects, dependence on obtaining and maintaining regulatory approvals, including acquiring and renewing federal, provincial, municipal, local or other licenses and engaging in activities that could be later determined to be illegal under domestic or international laws. Ketamine and psilocybin are currently Schedule I and Schedule III controlled substances, respectively, under the Controlled Drugs and Substances Act, S.C. 1996, c. 19 (the “CDSA”) and it is a criminal offence to possess such substances under the CDSA without a prescription or a legal exemption. Health Canada has not approved psilocybin as a drug for any indication, however ketamine is a legally permissible medication for the treatment of certain psychological conditions. It is illegal to possess such substances in Canada without a prescription.

These factors should be considered carefully, and readers are cautioned not to place undue reliance on such forward-looking statements. Although the Company has attempted to identify important risk factors that could cause actual actions, events or results to differ materially from those described in forward-looking statements, there may be other risk factors that cause actions, events or results to differ from those anticipated, estimated or intended. Additional information identifying risks and uncertainties that could affect financial results is contained in the Company’s filings with Canadian securities regulators, including the Amended and Restated Listing Statement dated April 15, 2021, which are available at www.sedar.com. There can be no assurance that forward-looking statements will prove to be accurate, as actual results and future events could differ materially from those anticipated in forward-looking statements.

Posted on

Clearmind Medicine and SciSparc Collaboration Yields Another Patent Application for Cocaine Addiction Treatment

Clearmind Medicine and SciSparc Collaboration Yields Another Patent Application for Cocaine Addiction Treatment

No dedicated treatment currently available for cocaine addiction

VANCOUVER, June 02, 2022 — 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 it has filed a provisional patent application related to cocaine addiction.The move results from the company’s recently launched collaboration with SciSparc Ltd. (NASDAQ: SPRC), a specialty clinical-stage pharmaceutical company focusing on the development of therapies to treat disorders of the central nervous system (“SciSparc“).

The patent application refers to the proprietary combination of Clearmind’s MEAI, a novel proprietary psychedelic treatment for addiction, with SciSparc’s CannAmide™. The two companies plan to pursue a pre-clinical trial to examine the effect of the combination treatment as an anti-reward agent for treating cocaine addiction.

Cocaine addiction in the United States peaked in the 1990s, and the current estimates by the National Institute on Drug Abuse claim at least 1.3million Americans are addicted to cocaine. Annually, these users go to the hospital more than 350,000 times and account for 54% of drug-related incarcerations in federal jails and prisons, according to recent statistics from the U. S. Department of Justice. In addition, cocaine is either suspected or confirmed as the cause for nearly 16,000 overdose deaths in the UnitedStates each year. It’s at least a contributing factor in many more deaths, usually from violence, associated medical conditions or other health impacts of the user’s lifestyle.

“Clearmind’s main focus is substance abuse and binge behaviors, ”said Dr. Adi Zuloff- Shani, Clearmind’s Chief Executive Officer. Dr. AdiZuloff- Shani continued, “Since the successful initial results demonstrated potential treatment for cocaine abuse, we intend to expand the collaboration with SciSparc and explore the effect of our combination treatment for cocaine. Although cocaine addiction is an established epidemic worldwide, it has no dedicated treatment in the market, which makes our candidate treatment highly attractive.”

About Clearmind Medicine Inc.

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. Shares of Clearmind are listed for trading on the Canadian Securities Exchange under the symbol “CMND“, the Frankfurt StockExchange under the symbol “CWY0” and on the OTC pink under the symbol “CMNDF“.

About SciSparc (NASDAQ: SPRC):

SciSparc Ltd. is a specialty clinical-stage pharmaceutical company led by an experienced team of senior executives and scientists. Our focus is on creating and enhancing a portfolio of technologies and assets based on cannabinoid pharmaceuticals. With this focus, the company is currently engaged in the following drug development programs based on THC and/or non-psychoactive cannabidiol (CBD): SCI-110 for the treatment of Tourette syndrome, for the treatment of obstructive sleep apnea and Alzheimer’s disease and agitation;SCI-160 for the treatment of pain; and SCI-210 for the treatment of autism spectrum disorder and status epilepticus.

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 RegulationServices Provider (as that term is defined in the policies of the CSE) accepts responsibility for the adequacy or accuracy of this release.

Posted on

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.

Posted on

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.