Posted on

Mindset Pharma Announces its Next Generation Novel 5-MeO-DMT Psychedelic Analogs Demonstrate a Significantly Improved Safety Profile in Preclinical Results

Mindset Pharma Announces its Next Generation Novel 5-MeO-DMT Psychedelic Analogs Demonstrate a Significantly Improved Safety Profile in Preclinical Results

Toronto, Ontario– August 31, 2021 – Mindset Pharma Inc. (CSE: MSET) (FSE: 9DF) (OTCQB: MSSTF)(“Mindset” or the “Company”), a drug discovery and development company focused on creating optimized and patentable next-generation psychedelic medicines to treat neurological and psychiatric disorders with unmet medical needs, today announced that compounds from its Family 4, comprised of DMT/5-MeO-DMT inspired analogs, have demonstrated a significant decrease in serotonergic toxicity, which can cause a range of mild to life-threatening symptoms, in head-to-head preclinical comparisons. Furthermore, the results reaffirm the Company’s previous findings that its Family 4 drug candidates demonstrated superior efficacy compared to 5-MeO-DMT.

“DMT and 5-MeO-DMT both show promise as medicinal psychedelics due to their short duration of action and high potency. However, our studies suggest that serotonergic toxicity could represent a considerable health risk as patients are more broadly treated with psychedelics, potentially leading to high blood pressure, tremors, delirium and a range of other symptoms,” said James Lanthier, CEO of Mindset. “Our exciting preclinical results suggest that our next generation drug candidates have the potential to offer a safer and more convenient solution for clinic-based therapy.”

“In-vivo models confirmed potential safety concerns associated with serotonergic toxicity of 5-MeO-DMT,indicated by a higher number of instances of 5-HT syndrome compared to some of Mindset’s NCE compounds,” stated Joseph Araujo, Chief Scientific Officer of Mindset. “These results indicate the potential for 5-MeO-DMT to induce serotonin syndrome, which is a consequence of excess serotonin (5-HT) agonism and can lead to serious health complications. However, some of Mindset’s drug candidates showed no signs of inducing 5-HT syndrome, suggesting a significantly improved safety profile compared to 5-MeO-DMT. Mindset’s Family 4 compounds can potentially be developed with marked improvements in safety, efficacy, and duration of action compared to 5-MeO-DMT, making them more suitable for a wider range of indications.”

Mindset’s Family 4compounds are DMT and 5-MeO-DMT inspired drug candidates that offer a broad range of pharmacological diversity suitable for in-clinic settings. The Company has run a battery of specialized in-vitro and in-vivo tests on its patent-pending novel compounds to select the optimal psychedelic drug candidates for progressing towards human clinical trials.

For more information, please contact:

Investor Contact:

Allison Soss/Tim Regan

KCSA Strategic Communications

Email: MindSet@kcsa.com

Phone: 212-896-1267/347-487-6788

 

Company Contact:

James Lanthier, CEO

Email: jlanthier@mindsetpharma.com

Jason Atkinson, VP,Corporate Development

Email: jatkinson@mindsetpharma.com

Phone: 416-479-4094

About Mindset Pharma Inc.

Mindset Pharma Inc. is a drug discovery and development company focused on creating optimized and patentable next-generation psychedelic medicines to treat neurological and psychiatric disorders with unmet needs. Mindset was established in order to develop next generation pharmaceutical assets that leverage the breakthrough therapeutic potential of psychedelic drugs. Mindset is developing several novel families of next generation psychedelic compounds, as well as an innovative process to chemically synthesize psilocybin as well as its own proprietary compounds.

For further information on Mindset, please visit our website at www.mindsetpharma.com.

‍Forward-Looking Information

This news release contains certain “forward-looking information” within the meaning of applicable securities law. Forward looking information is frequently characterized by words such as “plan”, “expect”, “project”, “intend”, “believe”, “anticipate”, “estimate”, “may”, “will”, “would”, “potential”, “proposed” and other similar words, or statements that certain events or conditions “may” or “will” occur. These statements are only predictions. Forward-looking information is based on the opinions and estimates of management at the date the information is provided and is subject to a variety of risks and uncertainties and other factors that could cause actual events or results to differ materially from those projected in the forward-looking information. Additional information regarding risks and uncertainties relating to the Company’s business are contained under the heading “Risk Factors” in the Company’s annual information form for the financial year ended June 30, 2020 dated March 5, 2021. The forward-looking information included in this news release is made as of the date of this news release and the Company does not undertake an obligation to publicly update such forward-looking information to reflect new information, subsequent events or otherwise, except as required by applicable law.

‍NEITHER THE CANADIAN SECURITIES EXCHANGE NOR ITS REGULATIONS SERVICES PROVIDER HAVE REVIEWED OR ACCEPTED RESPONSIBILITY FOR THE ADEQUACY OR ACCURACY OF THIS RELEASE.

Posted on

Field Trip Health Ltd. Announces Launch Of “Kap Co-Operative” Program, Enabling Independent Psychedelic Therapists To Practice At Its Field Trip Health Centers; Also Launches Training Programs To Educate A New Generation Of Psychedelic Clinicians

Field Trip Health Ltd. Announces Launch Of “Kap Co-Operative” Program, Enabling Independent Psychedelic Therapists To Practice At Its Field Trip Health Centers; Also Launches Training Programs To Educate A New Generation Of Psychedelic Clinicians

  • The KAP Co-op program gives eligible therapists the ability to provide ketamine-assisted psychotherapy (KAP) to their patients at Field Trip Health Centers utilizing Field Trip’s medical teams for screening, prescribing and administration of ketamine.
  • Training programs will provide both didactic and experiential training to therapists and medical professionals who wish to learn about KAP.
  • Therapists who complete Field Trip’s training programs will automatically become eligible to join the KAP Co-op program.

TORONTO, Aug. 31, 2021 (GLOBE NEWSWIRE) — Field Trip Health Ltd. (TSX: FTRP; FTRP.WT; Nasdaq: FTRP) (“Field Trip”), a leader in the development and delivery of psychedelic therapies, is pleased to announce the launch of “KAP Co-op”, a program that enables eligible independent psychedelic therapists to provide ketamine-assisted psychotherapy (and, in the future, other legal, psychedelic-assisted therapies) at its Field Trip Health centers. Field Trip is also pleased to announce the launch of training programs designed to provide interested psychotherapists or other qualified mental health professionals and clinicians with access to best-in-class training on KAP.

KAP Co-op Program

Under the KAP Co-op Program, independent therapists who are experienced at providing psychedelic-assisted therapies, or who completed approved training programs through providers including MAPS, Fluence, The Ketamine Training Center and the California Institute for Integral Studies (CIIS), amongst others, are eligible to become a co-operative therapist with Field Trip (“Co-op Therapists”).

Once approved, Co-op Therapists will have access to Field Trip’s world class centers for psychedelic therapies and other resources from Field Trip to provide KAP to their own private practice clients (“Co-op Clients”).

Co-op Clients will be able to access Field Trip’s medical teams for the screening, prescribing and administration/dispensation of ketamine, while continuing to receive all preparation and integration therapy from their existing therapist.

The cost of the medical screening and ketamine administration/dispensation at a Field Trip Health center for Co-op Clients will be available for an introductory price of $400 for a limited period. The cost of the preparation and integration therapy will be established directly between the Co-op Client and the Co-op Therapist as part of their existing therapeutic relationship within the therapist’s private practice.

“The launch of the KAP Co-op Program extends Field Trip’s presence to a whole new population of therapists and their clients who want to have the Field Trip experience and access our world class Field Trip Health centers,” said Hannan Fleiman, Field Trip’s President. “Now, instead of operating in parallel to existing client-therapist relationships, Field Trip is working on a truly complementary and co-operative basis to the incredible work all psychedelic therapists are doing with their clients.”

Training Programs

Field Trip’s training programs will provide a blend of didactic and experiential training for the delivery of KAP, and will be provided over the course of a weekend (Friday – Sunday). Topics covered in the training programs will include: preparation for psychedelic therapy, techniques for guiding a psychedelic experience, and integration of insights from a psychedelic experience.

The first session of Field Trip’s therapist training program will take place on the weekend of October 8, 2021 in Seattle, WA, and will cost $1,200 USD. Future sessions will be announced at a later time and will be held at Field Trip’s various Field Trip Health center locations.

“Many therapists are eager to get practical, hands-on experience with psychedelic-assisted therapies so they can confidently start offering these powerful modalities to their clients,” said Dr. Ryan Yermus, Field Trip’s Chief Clinical Officer. “Presently, however, the options available for training are limited and are either cost prohibitive, infrequent, long or do not include hands-on training. With the launch of Field Trip’s training programs, we are making training for therapists accessible and affordable. But what is even more exciting is with the launch of our KAP Co-operative Program, therapists will be able to quickly put that training to use.”

“Therapists are on the frontline of the global mental health crisis. And everyday more evidence confirms that the best tools we have to address this crisis are psychedelic-assisted therapies,” said Ronan Levy, Field Trip’s Executive Chairman. “The best thing we can be doing right now is to equip an army of therapists with what they need to deliver these powerful therapies. And that’s exactly what Field Trip is doing. Through our training programs and our KAP Co-op Program, any qualified therapist that wants to provide psychedelic-assisted therapies will have access to the training, facilities and medical resources they need to do so.”

“I genuinely believe that in 20 years we might look back and see that the launch of these programs, along with the incredible progress we are making in advancing the science and understanding of psychedelic molecules such as FT-104, marked a turning point in the mental health crisis we are battling,” he added.

Therapists and clinicians interested in participating in KAP Co-op or Field Trip’s training programs should send an indication of interest to coop@fieldtriphealth.com or training@fieldtriphealth.com, respectively.

About Field Trip Health Ltd.

Field Trip is a global leader in the development and delivery of psychedelic therapies. With our Field Trip Discovery division leading the development of the next generation of psychedelic molecules and conducting advanced research on plant-based psychedelics and our Field Trip Health division building centers for psychedelic therapies opening across North America and Europe along with the digital and technological tools that will enable massive scale, we help people in need with a simple, evidence-based way to heal and heighten engagement with the world.

Learn more at https://www.meetfieldtrip.com, https://www.fieldtriphealth.com and https://www.fieldtriphealth.nl.

Follow us on Twitter and Instagram: @fieldtriphealth

To receive company updates about Field Trip and to be added to the email distribution list please sign up here.

Cautionary Note Regarding Forward-Looking Information  

This release includes forward-looking information (within the meaning of Canadian securities laws and within the meaning of the United States Private Securities Litigation Reform Act of 1995) regarding Field Trip and its business. Often but not always, forward-looking information can be identified by the use of words such as “expect”, “intends”, “anticipated”, “believes” or variations (including negative variations) of such words and phrases, or state that certain actions, events or results “may”, “could”, “would” or “will” be taken, occur or be achieved. Such statements are based on the current expectations and views of future events of the management of Field Trip, and are based on assumptions and subject to risks and uncertainties. Although the management of Field Trip believes that the assumptions underlying these statements are reasonable, they may prove to be incorrect. The forward-looking events and circumstances discussed in this release may not occur and could differ materially as a result of known and unknown risk factors and uncertainties affecting the companies, including interest in the training program, interest in the KAP Co-Op Program, uptake of the KAP Co-Op Program by therapists and patients, the timing and results of its research and development programs, approval of phase 1 human trials, if any, the risk that future clinical studies may not proceed as expected or may produce unfavorable results, the opening of additional clinics, the COVID-19 epidemic, the medical clinic industry, market conditions, economic factors, management’s ability to manage and to operate the business and the equity markets generally. Although Field Trip has attempted to identify important factors that could cause actual actions, events or results to differ materially from those described in forward-looking statements, there may be other factors that cause actions, events or results to differ from those anticipated, estimated or intended. Accordingly, readers should not place undue reliance on any forward-looking statements or information. No forward-looking statement can be guaranteed. Except as required by applicable securities laws, forward-looking statements speak only as of the date on which they are made and Field Trip does not undertake any obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events, or otherwise.

This press release does not constitute an offer to sell or the solicitation of an offer to buy securities.

Neither the Toronto Stock Exchange, nor its Regulation Services Provider, have approved the contents of this release or accept responsibility for the adequacy or accuracy of this release.

Media contacts:
Rachel Moskowitz
Autumn Communications
202-276-7881
press@fieldtriphealth.com

Nick Opich / McKenna Miller
KCSA Strategic Communications
212-896-1206 / 347-487-6197
press@fieldtriphealth.com

Investor contacts:
Elizabeth Barker
KCSA Strategic Communications
212-896-1203
ebarker@kcsa.com

SOURCE Field Trip Health Ltd.

Posted on

PsyBio Therapeutics Reports Second Quarter 2021 Financial Results and Provides Corporate Update on Intellectual Property and Clinical Development Milestones

PsyBio Therapeutics Reports Second Quarter 2021 Financial Results and Provides Corporate Update on Intellectual Property and Clinical Development Milestones

OXFORD, Ohio and COCONUT CREEK, Fla., Aug. 30, 2021 /CNW/ – PsyBio Therapeutics Corp. (TSXV: PSYB) (OTCQB: PSYBF)  (“PsyBio” or the “Company“), an intellectual property driven biotechnology company developing novel formulations of psychoactive drugs produced by genetically modified bacteria and other innovative mediums for the potential treatment of mental health challenges and other neurological disorders, today reported its unaudited financial results for the three-month period ended June 30, 2021 and provided shareholders with a corporate update.

Second Quarter 2021 Financial Results

A copy of the unaudited condensed consolidated interim financial statements prepared in accordance with International Financial Reporting Standards and the corresponding management’s discussion and analysis for the three months ended June 30, 2021, can be found under PsyBio’s profile at www.sedar.com.

Intellectual Property and Clinical Development Milestones

  • The Company initiated a European pilot scale batch manufacturing of its psychedelic portfolio of compounds with the proprietary biosynthetic formulation of psilocybin in collaboration with Biose Industrie (“Biose“) in Aurillac, France. The partnership with Biose will advance the Company’s research and development goals and continue its endeavor to the development of globally-tested and approved therapeutics.
  • The Company has filed the following patent applications with the United States Patent and Trademark Office (the “USPTO“), bringing the Company’s intellectual property portfolio to seven, pending provisionals and one pending non-provisional patent application:
    • PsyBio filed a new provisional patent application with the USPTO entitled Psilocybin and Norbaeocystin Compositions and Methods of Treatment which contains 67 new inventive claims. This new patent application results from the Company’s latest testing demonstrating preliminary enhancement of efficacy when compounds are combined, suggesting powerful synergies exist between certain tryptamines which may signal improved therapeutic profiles and safety.
    • The Company initiated a new program to study N-methyl-D-aspartate (“NMDA“) receptor antagonists and associated analogs for potential activity against a variety of human health conditions. Concurrently, the Company filed a new provisional patent application with the USPTO entitled NMDA Receptor Antagonist-Containing Compositions and Methods of Treatment. The addition of NMDA receptor antagonists with pending patent protection is highly focused on the potential improvement of neurological conditions including traumatic brain injury, other neurological deficits and addiction as well as other psychological conditions.
    • The Company filed a new provisional patent application with the USPTO entitled Methods for the Production of a Methylated Tryptamines and Intermediates or Side Products, adding additional methylated tryptamines including compounds such as N,N-Dimethyltryptamine (DMT) and associated analogs for development of potential treatments for a variety of human health conditions.

Corporate Finance Update

  • The Company listed its Shares for trading on the OTCQB Venture Market (the “OTCQB“) at the market open on July 14, 2021 under the symbol “PSYBF”. The listing on the OTCQB positions PsyBio with increased visibility among the U.S.-based investment community, and is intended to improve liquidity for the Company’s current and prospective shareholders.
  • The Company recently announced TSX Venture Exchange (“TSXV“) approval of a sharebuyback program (the “Share Buyback Program“) for up to 2,983,951 subordinate voting shares in the capital of the Company (the “Shares“), representing five percent of the issued and outstanding Shares, and the entering into of a dealer agreement and automatic share purchase plan (the “ASPP“) with Haywood Securities Inc. in respect of the Share Buyback Program. While the Company has acquired no Shares since the Sharebuyback Program became effective on June 30, 2021, management of the Company and the Board of Directors of the Company continue to believe that the current market price of the Shares does not adequately reflect their value. The Company will continue to consider making purchases through the facilities of the TSXV, subject to the terms and conditions set forth in the ASPP.   

About PsyBio Therapeutics Corp.

PsyBio Therapeutics is an intellectual property driven biotechnology company developing novel formulations of psychoactive medications produced by genetically modified bacteria for the treatment of mental health challenges and other disorders. The team has extensive experience in drug discovery based on synthetic biology and metabolic engineering as well as clinical and regulatory expertise progressing drugs through human studies and regulatory protocols. Research and development is currently ongoing for naturally occurring psychoactive tryptamines originally discovered in different varieties of hallucinogenic mushrooms, other tryptamines and phenethylamines and combinations thereof. The Company is also researching and developing new non-naturally occurring molecular structures which may have unique therapeutics properties.

Cautionary Note Regarding Forward-Looking Statements

This press release contains statements that constitute “forward-looking information” (“forward-looking information“) within the meaning of applicable Canadian securities legislation. All statements, other than statements of historical fact, are forward-looking information and are based on expectations, estimates and projections as at the date of this news release. Any statement that discusses predictions, expectations, beliefs, plans, projections, objectives, assumptions, future events or performance (often but not always using phrases such as “expects”, or “does not expect”, “is expected”, “anticipates” or “does not anticipate”, “plans”, “budget”, “scheduled”, “forecasts”, “estimates”, “believes” or “intends” or variations of such words and phrases or stating that certain actions, events or results “may” or “could”, “would”, “might” or “will” be taken to occur or be achieved) are not statements of historical fact and may be forward-looking information. Forward looking-statements in this press release include statements regarding: the ability of PsyBio to develop novel formulations to potentially treat neurologic and psychologic conditions and other disorders; the ability of PsyBio to launch clinical trials; the ability of PsyBio to build its intellectual property portfolio of novel drug candidates; the ability of PsyBio to move target candidates into scaled commercial manufacturing and regulatory application; the ability to achieve cost competive synthesis with reduced environmental impact over current production methods; and the ability of PsyBio to move target candidates into scaled commercial manufacturing and regulatory application.

In disclosing the forward-looking information contained in this press release, the Company has made certain assumptions, including that: PsyBio will be successful in protecting its intellectual property; PsyBio will be successful in discovering new valuable target molecules; PsyBio will file its initial pre-Investigational New Drug (“IND“) Application request and IND Application within anticipated timeframes; PsyBio will be successful in obtaining IND Applications and will be able to obtain all necessary approvals for clinical trials; PsyBio will be successful in launching clinical trials; the results of preclinical safety and efficacy testing will be favourable; PsyBio’s technology will be safe and effective; a confirmed signal will be identified in PsyBio’s selected indications; and that drug development involves long lead times, is very expensive and involves many variables of uncertainty. Although the Company believes that the expectations reflected in such forward-looking information are reasonable, it can give no assurance that the expectations of any forward-looking information will prove to be correct. Known and unknown risks, uncertainties, and other factors which may cause the actual results and future events to differ materially from those expressed or implied by such forward-looking information. Such factors include, but are not limited to: compliance with extensive government regulations; domestic and foreign laws and regulations adversely affecting PsyBio’s business and results of operations; decreases in the prevailing process for psilocybin and nutraceutical products in the markets in which PsyBio operates; the impact of COVID-19; and general business, economic, competitive, political and social uncertainties. Accordingly, readers should not place undue reliance on the forward-looking information contained in this press release. Except as required by law, the Company disclaims any intention and assumes no obligation to update or revise any forward-looking information to reflect actual results, whether as a result of new information, future events, changes in assumptions, changes in factors affecting such forward-looking information or otherwise.

PsyBio makes no medical, treatment or health benefit claims about PsyBio’s proposed products. The United States Food and Drug Administration (“FDA“) or other similar regulatory authorities have not evaluated claims regarding psilocybin and other next generation psychoactive compounds. The efficacy of such products has not been confirmed by FDA-approved research. There is no assurance that the use of psilocybin and other psychoactive compounds can diagnose, treat, cure, or prevent any disease or condition. Vigorous scientific research and clinical trials are needed. PsyBio has not conducted clinical trials for the use of its intellectual property. Any references to quality, consistency, efficacy and safety of potential products do not imply that PsyBio verified such in clinical trials or that PsyBio will complete such trials. If PsyBio cannot obtain the approvals or research necessary to commercialize its business, it may have a material adverse effect on the PsyBio’s performance and operations.

The TSXV has neither approved nor disapproved the contents of this news release. Neither the TSXV nor its Regulation Services Provider (as that term is defined in the policies of the TSXV) accepts responsibility for the adequacy or accuracy of this release.

SOURCE PsyBio Therapeutics Corp.

For further information: Evan Levine, CEO, PsyBio Therapeutics Corp., t: 513.449.9585, e: ir@psybiolife.com; Investor Enquiries: Valter Pinto or Tim Regan, KCSA Strategic Communications, t: 212.896.1254, e: valter@kcsa.com

Posted on

Braxia Scientific Reports First Quarter 2022 Financial Results; Company Achieves 80% Revenue Growth from Expanding Clinic Patient Base

Braxia Scientific Reports First Quarter 2022 Financial Results; Company Achieves 80% Revenue Growth from Expanding Clinic Patient Base

  • Revenue from four Canadian clinics increased 80.3% to $407,075 year-over-year
  • Exceeding monthly IV Ketamine infusion targets, ramping up infusions at new Montreal clinic
  • Advancing three funded clinical trials through Braxia Scientific’s network of clinics, including a Ketamine trial for Bipolar Depression, a Ketamine trial to rapidly reduce suicidality, and the first multiple-dose psilocybin trial to combat treatment-resistant depression

TORONTO, ONTARIO Aug. 30, 2021 – Braxia Scientific Corp. (“Braxia Scientific,” or the “Company”), (CSE: BRAX) (OTC: BRAXF) (FWB: 496), a medical research company with clinics providing innovative ketamine treatments for persons with depression and related disorders, today announced the filing of its fiscal first-quarter results for the three-month period ending June 30, 2021. Complete financial statements along with related management discussion and analysis can be found in the System for Electronic Document Analysis and Retrieval (SEDAR), the electronic filing system for the disclosure documents of issuers across Canada, at www.SEDAR.com.

With its leading researchers and experienced implementation team, Braxia Scientific continues to focus on its three strategic priorities: (i) expand its footprint of multidisciplinary clinics providing IV Ketamine for mental health disorders, (ii) identify new, IP-capable ketamine and psychedelic derivatives, as well as novel delivery systems, and to capitalize on new formulations by implementing them within Braxia Health’s clinical settings, and (iii) train new clinicians through the Braxia Institute to administer psychedelic-assisted therapy based on the International Guidelines published by Braxia Scientific Leadership.

Through its vertically integrated model, Braxia Scientific is differentiated by way of its capability to achieve a shortened research and development timeline that, along with the track record and relationships already established by the Company’s leadership, will enable partnerships with large pharmaceutical companies.

“As one of very few clinics offering IV Ketamine therapy in Canada since 2018, and the first private IV Ketamine clinic in Quebec, we have set the standard in care through our protocols and team of psychiatrists and nurses. As a result, we are pleased to be accepting an increasing number of referrals for patients with depression in need of rapid-acting and effective treatments,” said Dr. Roger McIntyre, CEO of Braxia Scientific.

“In addition to our clinics, we are executing on our strategy to test out innovative formulations and delivery methods. We are working to achieve key milestone objectives such as demonstrating the proof of mechanism, and that they actually affect the brain and attenuate depression – which has a one- to two-year runway.”

“We are in discussions with major drug manufacturers as to how we can move the needle for ketamine and psychedelic derivatives, with a view to refining our therapeutic research priorities in developing new products that could be ultimately acquired by large pharma.”

Recent Operational Highlights

Increasing Patient Volume: Braxia Scientific, through its four multidisciplinary, community-based Canadian clinics, operating as Braxia Health, continued to see increased patient volume, exceeding its IV ketamine infusion targets every month since January 2021. These results partially reflect increased treatments from its newest clinic in Montreal, which has ramped up operations since the Company, in conjunction with its joint venture partner, Neurotherapy Montreal, successfully opened March 31, 2021. This new location, which is the first to offer novel Ketamine therapy, including intravenous therapy, to patients in a private clinical setting in Quebec, required eight (8) weeks, from initial resource deployment to the first patient visit, to become operational, including all necessary education and training.

Braxia Health’s clinical operations also benefited from several other key accomplishments in the quarter. The Company successfully brought on several more psychiatrists, nurses, family doctors and an anesthesiologist; optimized the clinical intake process with new software, allowing doctors to see more patients and provide better care; established direct billing practices with a major Canadian health insurer; and increased marketing initiatives and engagement with psychiatrists across Ontario about Braxia Health clinics and offerings.

Funded Clinical Trials, Leading Research and Development: Supported by its network of clinics, Braxia Scientific’s world-leading scientific research team is advancing multiple research and development studies and conducting clinical trials with IV Ketamine, Ketamine derivatives and other psychedelic drugs.

In August 2021, the Company announced it would commence a landmark clinical trial to conduct Canada’s first multiple-dose psilocybin study for treatment-resistant depression (TRD). Whereas most other TRD studies limit participation to patients that have not found relief from a maximum of five other potential remedies, Braxia Scientific’s research will not have an upper limit, and will even include patients that have endured dozens of unsuccessful medical trials, including ketamine and electroconvulsive therapy.

The Company is confident that the study will demonstrate that the Company can effectively conduct a randomized controlled trial using psychedelic-assisted therapy. This will enable the Company to build the infrastructure for future studies and future clinical care, while also compiling efficacy data and providing the opportunity to evaluate the therapist training program launched at the end of June 2021.

This program run by the Braxia Institute, the Company’s training centre focused on advancing psychiatric clinical practice and health services of ketamine and psychedelic treatment therapy, has already cultivated a multi-disciplinary group of 20 therapists from diverse psychiatry and psychotherapy backgrounds to implement safe and effective psilocybin-assisted therapy for patients with depression.

In June 2021, the Company announced that Chief Medical and Scientific Officer Dr. Joshua Rosenblat will initiate a first-of-its-kind ketamine clinical trial to treat bipolar depression. The fully funded study represents the largest registered trial of its kind in the world, and will investigate the use, safety and efficacy of repeated doses of IV ketamine in patients with bipolar depression. This trial will enable Braxia-led research teams to further advance studies of IV ketamine to support its approval as a safe, effective and rapid-acting alternative treatment for patients with bipolar depression.

Braxia Scientific Researchers Leading Innovation and Education

Braxia Scientific’s research and development team continued to execute on several research initiatives during the quarter, achieving several key milestones, including completing a study evaluating genetic predictors of how patients may respond to ketamine, as well as continuing to develop a new topical ketamine formulation and intranasal ketamine product.

The Company was pleased to announce the publication of the International Expert Opinion and Implementation Guidance (the “Guidelines”) for the clinical use of rapid-acting Ketamine and Esketamine for treatment-resistant depression (TRD) in the American Journal of Psychiatry. The Guidelines were developed by Dr. McIntyre and Dr. Rosenblat, along with an international group of 26 medical experts across five continents, establishing Braxia Scientific as an international leader in the rapidly evolving industry of Ketamine, Esketamine and rapid-acting antidepressants.

The Company also launched the Braxia Institute, a training centre focused on advancing psychiatric clinical practice and health services of ketamine and psychedelic treatment therapy for people with treatment-resistant depression and other possible mental health disorders. Through its research-backed training programs, the Braxia Institute is focused on advancing the knowledge base of psychiatrists, physicians and other health-care professionals globally, closing the extraordinary gap between clinical practice groups around the world and the protocols, competencies and best practices identified through peer-reviewed published research.

The Braxia Institute opened enrollment to develop, train, and support a new generation of qualified, independent medical physicians, psychologists, and psychotherapists to implement safe and effective psilocybin-assisted therapy for patients with depression. The therapists will participate in the provision of psychotherapy in upcoming clinical trials at Braxia Health clinics, evaluating the safety and efficacy of psilocybin in treating depression. The Company anticipates that, pending regulatory approval of psilocybin, therapists would also be trained to implement psychedelics in clinical practice.

First Quarter Financial Summary

The Company recorded strong revenues of $407,075 and a gross margin of $114,253 for the first fiscal quarter ended June 30, 2021 reflecting annual increases of 80.3% and 89.7%, respectively, from the results for the first fiscal quarter ended June 30, 2020.

Revenues consisted primarily of sales revenue from the administering of ketamine infusion treatments at the CRTCE clinics in Ontario and Quebec.

As a percentage of total revenue, gross margin was approximately 28.1%, an increase of 139 basis points, when compared with the previous year’s corresponding period.

The Company recorded a net loss for the quarter of $1,091,568, including a non-cash share-based compensation expense of $294,758.

Balance Sheet

The Company’s cash and cash equivalents as of June 30, 2021, was $10,257,759, compared with $11,101,005 as at March 31, 2021.

Looking Ahead

“Braxia Scientific remains steadfastly focused on addressing the public health imperative to identify scalable solutions for attenuating depression and other brain-based disorders to improve the health and well-being of Canadians and people around the world,” said Dr. McIntyre.

“We believe the federal funding received by our senior team members speaks to our superior human capital, as well as our personnel’s long, successful track record of quality research and development. As we seek to expand our network of clinics, particularly into the United States, we look forward to implementing their findings, carrying out several clinical trials, the majority of which will be funded by third parties.”

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 mental 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

Red Light Holland and Creso Pharma Agree to Terminate Merger

Red Light Holland and Creso Pharma Agree to Terminate Merger

Toronto, Ontario–(Newsfile Corp. – August 30, 2021) – Red Light Holland Corp. (CSE: TRIP) (FSE: 4YX) (OTC Pink: TRUFF) (“Red Light Holland”), an Ontario-based corporation engaged in the production, growth and sale of magic truffles to the legal, recreational market within the Netherlands, announced today that Red Light Holland and Creso Pharma Limited (ASX: CPH) (FSE: 1X8) (OTCQB: COPHF) (“Creso Pharma”) have mutually agreed to terminate the previously announced definitive scheme implementation deed (the “Deed”).

Red Light Holland and Creso Pharma had originally entered into the Deed to implement a merger of the companies (the “Merger”) in June 2021. However, as a result of various impacts from the COVID-19 pandemic, including significant travel restrictions, Red Light Holland and Creso Pharma have mutually concluded that the Merger would no longer be in the best interests of their respective shareholders. As the two companies have significant operations in multiple countries across the globe, it became increasingly apparent that integration difficulties would limit the anticipated synergies from the proposed Merger. As a result, both Red Light Holland and Creso Pharma have agreed to mutually terminate the Deed, while remaining allies in their mission to provide consumers with formerly illicit and functional substances across the world, while strengthening their respective technology, innovation and applied sciences divisions.

“While we determined that a merger was no longer in the best interests of the two companies, we look forward to continuing to work closely with Adam Blumenthal and the rest of the Creso Pharma team as Red Light Holland has agreed to white-label Creso Pharma’s products and distribute them across our SR-Wholesale sales channels,” said Todd Shapiro, CEO and Director of Red Light Holland. “We are also continuing our search for other M&A opportunities as we are confident that our large cash balance puts us in a position of strength as potential progressive regulatory changes in the North American psychedelic and recreational cannabis sectors open up.”

“We respect Todd Shapiro and the entire team at Red Light Holland. Unfortunately, the geographic span of our respective businesses made a merger at this time impractical,” added Creso Pharma’s Non-Executive Chairman, Adam Blumenthal. “We look forward to working with the Red Light Holland team through our new supply arrangement.”

Red Light Holland is pleased to announce that Bruce Linton, the founder and former chief executive officer of Canopy Growth Corporation, will remain as a Chairman of Red Light Holland’s Advisory Board.

For additional information on Red Light Holland:

Todd Shapiro
Chief Executive Officer & Director
Tel: 647-204-7129
Email: todd@redlighttruffles.com
Website: https://redlighttruffles.com/

About Red Light Holland

Red Light Holland is an Ontario-based corporation engaged in the production, growth and sale (through existing Smart Shops operators and an advanced e-commerce platform) of a premium brand of magic truffles to the legal market within the Netherlands, in accordance with the highest standards, in compliance with all applicable laws.

Forward-looking statements

This news release contains “forward-looking information” within the meaning of applicable Canadian securities legislation. Often, but not always, forward-looking statements and information can be identified by the use of words such as “plans”, “expects” or “does not expect”, “is expected”, “estimates”, “intends”, “anticipates” or “does not anticipate”, or “believes”, or variations of such words and phrases or state that certain actions, events or results “may”, “could”, “would”, “might” or “will” be taken, occur or be achieved. Forward-looking information involves known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements of Red Light Holland or its subsidiaries to be materially different from any future results, performance or achievements expressed or implied by the forward-looking information contained in this news release. Examples of such information include statements with respect the new supply arrangement between Red Light Holland and Creso Pharma, future acquisition opportunities and expectations for other economic, business and/or competitive factors. Risks, uncertainties and other factors involved with forward-looking information could cause actual events, results, performance, prospects and opportunities to differ materially from those expressed or implied by such forward-looking information, including the expectations regarding future investment, growth and expansion of the operations of the businesses; regulatory and licensing risks; changes in general economic, business and political conditions, including changes in the financial and stock markets; risks related to infectious diseases, including the impacts of the COVID-19 pandemic; legal and regulatory risks inherent in the cannabis and magic psychedelics industries, including the global regulatory landscape and enforcement related to cannabis and psychedelics, political risks and risks relating to regulatory change; risks relating to anti-money laundering laws; compliance with extensive government regulation and the interpretation of various laws regulations and policies; public opinion and perception of the cannabis and psychedelics industries; and such other risks contained in the public filings of Red Light Holland filed with Canadian securities regulators and available under Red Light Holland’s profile on SEDAR at www.sedar.com, including Red Light Holland’s annual information form for the year ended March 31, 2020.

Red Light Holland has provided forward-looking information in reliance on certain assumptions that they believe are reasonable at this time. Although Red Light Holland believes that the assumptions and factors used in preparing the forward-looking information in this news release are reasonable, undue reliance should not be placed on such information and no assurance can be given that such events will occur in the disclosed time frames or at all. Should one or more of the foregoing risks or uncertainties materialize, or should assumptions underlying the forward-looking information prove incorrect, actual results may vary materially from those described herein as intended, planned, anticipated, believed, estimated or expected. Although Red Light Holland has attempted to identify important risks, uncertainties and factors which could cause actual results to differ materially, there may be others that cause results not to be as anticipated, estimated or intended. The forward-looking information included in this news release are made as of the date of this news release and Red Light Holland does not undertake any obligation to publicly update such forward-looking information to reflect new information, subsequent events or otherwise unless required by applicable securities laws.

Posted on

The best way to take psilocybin?

New partnership formed to create psilocybin patch for mental health conditions

A Hawaiian company called Ei.Ventures is partnering with Tioga Research to develop a new psilocybin delivery method.
The companies are developing a patch that delivers psilocybin through the skin using the same transdermal technology found in nicotine patches.

The patch allow for more stable delivery of psilocybin and could prevent nausea that often occurs with oral administration. The product is designed for high doses of psilocybin, but could potentially be used to deliver microdoses for mental clarity and mood stabilization too.

Sounds a bit nicer than the nasal sprays and injection devices that other companies are working on!

Posted on

Slow and steady wins the race

California Bill To Legalize Psychedelics Possession Put On Pause Until 2022

California’s psychedelics decriminalization bill, SB519, has been put on hold until 2022, but it may be for the best.

The bill has already been approved by the Senate and 2 of 3 assembly committees, but has now been made into a two-year bill, meaning it won’t advance to the floor until next year.

Senator Scott Wiener (D), the bill’s sponsor, decided put things on pause as more time is needed to build the case for decriminalization and generate support.

“Now that we have more time, I’m optimistic through education and member engagement we can pass this critical legislation next year,” he explained.

PDF of article

Posted on

Revolutionizing all of healthcare?

This West Philly Doctor Says Psychedelic-Assisted Therapy Could Change Your Life

Psychedelic therapy clinics continue to pop up across North America.

Last week, a nonprofit organization called SoundMind Center officially opened in West Philadelphia, which will be dedicated to psychedelic research, treatment, and therapist training.

On Tuesday, another clinic called Innerbloom Healing Arts opened in Charleston, South Carolina. Both clinics currently offer ketamine-assisted therapy with plans to offer MDMA and psilocybin therapy as soon as possible.

“Psychedelics are not only going to revolutionize mental health. They have the ability to revolutionize all of healthcare. Changing the way we think about the relationship between mind and body. And health and disease”, said Dr. Hannah McLane, SoundMind’s founder.

 

Posted on

MINDCURE Reaches Milestone, Releasing First of its Kind Mental Health Digital Therapeutics Platform to Partner Clinics in North America

MINDCURE Reaches Milestone, Releasing First of its Kind Mental Health Digital Therapeutics Platform to Partner Clinics in North America

With its minimum viable product (MVP) release on schedule and on budget, MINDCURE will work with its clinical partners to refine the application before full commercial deployment in Q1 2022.

‍‍VANCOUVER, BC, August 26, 2021 – Mind Cure Health Inc. (CSE: MCUR) (OTCQB: MCURF) (FRA: 6MH) (“MINDCURE” or the “Company”), a leader in advanced proprietary technology and research for psychedelics, is pleased today to announce the release of the minimum viable product version of iSTRYM, its digital therapeutics platform (DTx) for psychedelics, into partner clinics across North America.

The Company will begin full commercial deployment to all clinics in Q1 of 2022. MINDCURE plans initially to target psychedelic clinics and to then expand to integrated clinics, both traditional and psychedelic, and eventually to the broader mental health market. The Company forecasts 150 clinics in Canada, the US, and Europe utilizing iSTRYM by Q4 2022.

“MINDCURE created iSTRYM with the goal of unlocking value for researchers, therapists, and ultimately patients in need,” said Dr. John Brownstein. “I believe there’s a real opportunity to improve mental health treatments through a better understanding of patient and research data, and that this platform can be a valuable resource for the entire psychedelics industry.”

Earlier this year, the Company appointed Dr. John Brownstein, the Chief Innovation Officer at Boston Children’s Hospital, as a Company Advisor. Dr. Brownstein has been granted stock options for serving as an Advisor to MINDCURE. An esteemed epidemiologist and professor at Harvard Medical School, Dr. Brownstein has been advising on MINDCURE’s digital therapeutics technology, patient data security, and data optimization.

Developing the distribution network of content and care protocols for psychedelic drugs will allow MINDCURE to create value at all levels of the value chain: client, clinic, protocol developer, and drug developer.

In line with the Company’s focus on its digital technology and research and development activities, the Company has discontinued the development of its nootropics line of products. “As our organization has grown and our bi-divisional technology and drug research strategy have been refined, we need to focus entirely on what we do best – creating advanced and proprietary technology for and drug research in psychedelics,” said Kelsey Ramsden.

“Digital Therapeutics is a key part of our value creation strategy, affording us near term revenue opportunities and the capacity to globalize our footprint across every psychedelic molecule in locations where they are being administered in care legally,” said Kelsey Ramsden, President & CEO, MINDCURE. “These new psychedelic medicines demand new models, and technology-enabled care that uses AI and scientific rigour have an important and valuable role to play. Having methodically built a world-class team and built this platform from the ground up to serve psychedelics and scale beyond, I am excited to share the MVP version with our strategic partners within the psychedelics industry.”

In other news, MINDCURE has retained KCSA Strategic Communications (“KCSA”), a leading New York City-based integrated communications firm, to provide public relations and investor relations services for a 6-month term beginning August 23, 2021. KCSA will be paid a monthly fee of US$27,000 as consideration for the provision of the services.

About iSTRYM

iSTRYM is a first-of-its-kind software application that optimizes the healing journey for both patients and clinicians — before, during, and after therapy sessions. By bringing together and building proprietary technological solutions, iSTRYM offers therapists global, evidence-backed treatment protocols, in-session psychedelic-informed tools, customizable dashboards, integration plans, insights into patient journeys, and real-time assessments for personalized client care.

To request a demo or learn more about iSTRYM, please visit istrym.com

‍

‍About Mind Cure Health Inc.

MINDCURE is a life sciences company focused on innovating and commercializing new ways to promote healing and improve mental health. The company is developing digital therapeutics technology and researching psychedelic compounds to support access to safe, evidence-based psychedelic-assisted therapies globally. Learn more at mindcure.com, and follow us on LinkedIn, Facebook, Twitter, and Instagram.

On Behalf of the Board of Directors

Kelsey Ramsden, President & CEO

Phone: 1-888-593-8995

Forward-Looking Information

Certain information presented in this news release may constitute “forward-looking information” within the meaning of applicable securities laws regarding MINDCURE and its business. Forward-looking information inherently entails known and unknown risks and uncertainties about the future and actual results, performance or achievements contemplated by forward-looking statements made may be materially different from the results anticipated or implied by such forward-looking information.Forward-looking information generally can be identified by the use of terms and phrases such as”anticipate”, “believe”, “could”, “estimate”, “expect”, “feel”, “intend”, “may”, “plan”, “predict”, “project”, “subject to”, “will”, “would”, and similar terms and phrases.

Forward-looking information is based on a number of key expectations and assumptions made by management of MINDCURE, including, without limitation: the COVID-19 pandemic impact on the Canadian economy and MINDCURE’s business, and the extent and duration of such impact; no change to laws or regulations that negatively affect MINDCURE’s business; there will be a demand for MINDCURE’s products in the future; no unanticipated expenses or costs arise; MINDCURE will be able to continue to identify products that make them ideal candidates for providing solutions for treating mental health; that iSTRYM will be developed, optimized and operate as contemplated within the psychedelics industry; that the Company will be effective in obtaining the patents applied for synthesizing ibogaine, or synthesizing ibogaine, or developing synthesized ibogaine for research, medical or commercial use; that MINDCURE will advance wellness worldwide; that iSTRYM will be brought to commercial deployment in the near term or otherwise; or that it will reduce symptoms, improve quality of life, and support transformation and healing, or that the deployment may not occur at the scale or within the time frame contemplated.

Although MINDCURE has attempted to identify important factors that could cause actual results, performance or achievements to differ materially from those described in forward-looking information presented, there may be other factors that cause results, performance or achievements to differ from those anticipated, estimated or intended. Accordingly, readers should not place undue reliance on any forward-looking statements as no forward-looking information can be guaranteed.

Except as required by applicable securities laws, forward-looking statements speak only as of the date on which they are made and MINDCURE does not undertake any obligation to publicly update or revise any forward-looking information, whether as a result of new information, future events, or otherwise.

For further information

MINDCURE Investor Relations

investors@mindcure.com

1-888-593-8995