A recent survey shows that spirituality increases with psychedelic use, and that increased spirituality is linked to improved emotional regulation. The findings suggest that better emotional regulation is associated with decreased scores for depression, anxiety, and disordered eating.
Here’s what’s in store for you in today’s issue:
🍄 The cure for the worst pain known to humans
🍄 Combining antidepressants and psilocybin
🍄 More positive findings from biggest psilocybin trial
🍄 Psychedelic cream?
🍄 And more.
In this episode of the Daily Mushroom Podcast, we have the CEO of Silo Wellness, Douglas Gordon. Silo Wellness offers legal, psychedelic retreats in Jamaica and Oregon. Their mission is heavily rooted in the education around the physical and mental benefits of mushrooms. We hope you enjoy this one!
Do patients need to come off of antidepressants before trying psilocybin therapy?
New research from MindMed (MNMD) and Liechti Labs suggests that it’s not necessary – and there are actually benefits of combining the two.
Escitalopram (aka Lexapro) did not affect the way psilocybin was processed and helped reduce negative side effects like anxiety and high blood pressure.
COMPASS Pathways (CMPS) announced additional findings from the world’s largest psilocybin trial for depression.
In addition to reduced depression scores, patients showed improvements in anxiety, daily functioning, cognition, and quality of life. Just one day after the treatment, patients had increased positive feelings such as “interested, excited, strong” and decreased negative feelings like “distressed, upset, afraid.”
Psycheceutical Inc., a private Florida company, is developing a unique way to deliver psychedelics – through a cream or patch applied to the back of the neck. This method allows psychedelics to enter the brain in just 5-10 minutes without entering the bloodstream, which reduces negative side effects.
Quantified Citizen is a platform made in collaboration with Paul Stamets to accelerate health research. It allows anyone to participate in studies anonymously from their phone.
The platform was used to conduct the world’s largest mobile microdosing study, which revealed that microdosers exhibit lower levels of depression, anxiety, and stress.
It’s not too late to participate – download the app here to join the study!
For years, Brad Badelt suffered from debilitating cluster headaches (which are often called “suicide headaches” and described as the worst pain known to humans.
After seeing countless neurologists, chiropractors, acupuncturists, and naturopaths, he would still experience the horrible headaches several times a day for weeks on end.
After taking one dose of shrooms, things finally changed.
“When I woke the next morning, I felt different: the mental fog brought on by my cluster headaches was gone. For the next twelve months, I remained headache free. Every year since, I’ve downed a dose of shrooms, and every year my cluster headaches have remained in remission.”
The Wakeful Integration Journal is your guide to transformation.
It’s the ultimate tool to help you prepare for, navigate, and deeply integrate your psychedelic experiences. The journal features:
If you want to start with microdosing rather than a full-on trip, the Wakeful Intention Journal is for you! It guides you through a 6-week microdosing protocol and helps you set intentions, notice patterns, and integrate your insights.
Support the Kickstarter here to receive a journal and begin your transformation journey!
MYND Life Sciences (MYND) received $45,600 in government funding to support a psilocybin research project on treatment resistant depression and neuroinflammation. The project will run now until March 2022.
Novamind (NM) partnered with Bienstar Wellness to develop the first network of integrative mental health clinics in Latin America. The companies plan to bring psychedelic medicine to Uruguay, Brazil, Mexico, Peru, and Panama.
PharmaTher (PHRM) was granted a Japanese patent for KETBET, a combination of ketamine and betaine anhydrous that can be used for various mental health and pain disorders. Betaine anhydrous enhances the antidepressant effect of ketamine while reducing the side effects.
Telescope Innovations (TELI) acquired the rights to the University of British Columbia’s research on synthetic psilocybin in exchange for 1M common shares at $0.99 each.
Bright Minds Biosciences (DRUG) announced that its drug discovery program has synthesized hundreds of patentable psychedelic compounds. Researchers are optimizing the most encouraging molecules and aim to announce the lead molecule early next year.
Shanti Therapeutics, a subsidiary of Global Wellness (GWS), is awaiting ethics committee approval to conduct one of the first studies on MDMA for pain management.
These companies announced their financial highlights:
The new limits will allow more researchers to study the drugs! Read more…
A Florida Rep. filed a bill to decriminalize all illegal substances and implement rehabilitative health intervention or civil fines instead. Read more…
A startup in the Netherlands is making biodegradable “living coffins” out of mushroom mycelium!
Not only do the coffins enrich the soil, but they allow “people to become one with nature again.”
After months of testing, the first funeral using a mushroom coffin was a success.
Silo Wellness (SILO) launched a line of functional mushroom products in collaboration with Bob Marley’s family!
The Marley One line features:
Use promo code DAILYMUSHROOM20 to get 20% off!
Nov 29 – Numinus (NUMI) Develops Proprietary Psychedelic Tests with New Toxicity and Potency Scans Read more…
Nov 29 – atai Life Sciences (ATAI) Increases its Ownership Position in COMPASS Pathways (CMPS) Read more…
Nov 30 – Cybin (CYBN) Announces FDA IND and IRB Approvals for Clinical Trial to Treat Frontline Clinicians with COVID-Related Distress Read more…
Dec 2 – Ketamine One (MEDI) Partners with Cognetivity Neurosciences in Collaborative Clinical Study on Depression and PTSD Read more…
Dec 2 – Tryp Therapeutics (TRYP) Receives Confirmation from FDA to Proceed with Phase 2a Study in Fibromyalgia Read more…
Nov 26 – Delic Corp’s (DELC) Ketamine Wellness Centers Opening Salt Lake City & Reno Locations Read more…
Ketamine Wellness Centers Opening Salt Lake City & Reno Locations
KWC Expands to Include 12 Locations by Q1 2022, Further Establishing its Position as the Nation’s Largest Chain of Wellness Clinics, Adds to Delic’s Network of Locations
VANCOUVER, BC, Dec. 2, 2021 /PRNewswire/ – Delic Holdings Corp (“Delic” or the “Company”) (CSE: DELC) (OTCQB: DELCF) (FRA: 6X0) (Original Source), a leader in new medicines and treatments for a modern world, today announced its subsidiary Ketamine Wellness Centers (KWC) plans to open two new clinics in Salt Lake City, Utah, and Reno, Nevada, by February 2022. KWC was acquired by Delic in September 2021 and currently operates 10 ketamine infusion treatment clinics across eight states, delivering more than 60,000 treatments to date across Arizona, Colorado, Florida, Illinois, Minnesota, Nevada, Texas and Washington.
KWC Salt Lake City, located in the suburb of Taylorsville at 6087 South Redwood Road, Suite B, is the first of the company’s clinics in Utah and is expected to open on January 10, 2022. The facility, which allows for up to seven treatment rooms, will become one of KWC’s largest clinics in the U.S.
KWC Reno, opening in February 2022, will be KWC’s second clinic in Nevada and is strategically positioned to not only serve local residents but also patients in larger California markets who do not have access to affordable in-state providers.
“Offering accessible, personalized and high-quality care is integral to Ketamine Wellness Centers’ mission, and we look forward to supporting the emotional wellness of new patients in Utah and Nevada,” said Kevin Nicholson, CEO of KWC and Chief Operating Officer for Delic. “As the nation grapples with the ongoing silent mental health crisis, we are committed to helping patients struggling with various conditions get back control over their lives again and find relief through these powerful treatments.”
Through these latest openings, Delic continues to execute its strategy of expanding ketamine treatment centers to secondary cities in order to reach the greatest number of patients and provide reasonably priced treatments.
Matt Stang, co-founder and CEO of Delic, commented, “Demand for mental health services continues to climb year over year, with one in five U.S. adults experiencing a mental health condition. However, patients around the country still lack access to affordable and effective options. Through the largest chain of wellness clinics offering ketamine treatments in the U.S., Delic aims to directly address this critical issue by focusing our efforts on expanding access to these best-in-class treatments to more people every day. We believe affordable, effective treatments with minimal side effects should be available to anyone who needs them.”
In addition to the 12 KWC clinics, Delic’s existing portfolio also includes two clinics operated by Ketamine Infusion Centers LLC (“KIC”) in California and Arizona, cementing its position as the leading and largest psychedelic wellness provider in the country. Delic expects to open 13 additional clinics across the country over the coming 18 months, further expanding access to millions who can benefit from new medicines and treatments for a variety of mental health conditions and adds to their position as a central hub of education, media, and cultural conversations around these new medicines and treatments.
Delic is committed to addressing the mental health crisis by increasing access to science-backed benefits for all and reframing the psychedelic conversation. The company does this through an umbrella of related owned and operated businesses to support scaling the impact and reach of treatment, including 1) the largest and most accessible network of physical clinics to administer effective treatments, 2) a licensed lab to develop IP, R&D and innovative high quality and safe product lines, and 3) trusted media and e-commerce platforms and in-person events to market the services directly to patients and consumers and gain data.
For more information about Ketamine Wellness Centers’ locations, services and hours of operation, please visit https://www.ketaminewellnesscenters.com/locations/.
About Ketamine Wellness Centers
Ketamine Wellness Centers (KWC) is the largest ketamine therapy provider in the United States with 12 clinic locations serving communities across nine states. Since 2011 KWC has been a trusted leader in bringing IV ketamine therapy into mainstream health care. KWC has provided over 60,000 treatments to clinically eligible patients, from young adults to seniors, in addition to developing specialized programs for veterans and first responders. The KWC team, including a core group of physicians, psychologists, clinicians, and executives, is dedicated to providing value-based, personalized, clinically controlled ketamine infusion care for people suffering from treatment-resistant depression, anxiety, PTSD, OCD and chronic pain. KWC’s scalable business and treatment model is designed for further rapid expansion along with breakthrough innovations in effective therapies and services.
About Delic Corp
Delic is a leader in new medicines and treatments for a modern world, improving access to health benefits across the country and reframing the conversation on psychedelics. The company owns and operates an umbrella of related businesses, including the largest chain of psychedelic wellness clinics in the country, including Ketamine Infusion Centers and Ketamine Wellness Centers; the only licensed entity by Health Canada to exclusively focus on research and development of psilocybin vaporization technology, Delic Labs; the premier psychedelic wellness event, Meet Delic; and trusted media and e-commerce platforms Reality Sandwich and Delic Radio. Delic is backed by a team of industry and cannabis veterans and a diverse network, whose mission is to provide education, research, high-quality products, and effective treatment options to the masses.
The Canadian Securities Exchange has neither approved nor disapproved the contents of this news release and does not accept responsibility for the adequacy or accuracy of this release.
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 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 unless registered under the U.S. Securities Act and applicable state securities laws or an exemption from such registration is available.
Forward-Looking Information and Statements
This press release contains certain “forward-looking information” within the meaning of applicable Canadian securities legislation and may also contain statements that may constitute “forward-looking statements” within the meaning of the safe harbor provisions of the United States Private Securities Litigation Reform Act of 1995. Such forward-looking information and forward-looking statements are not representative of historical facts or information or current condition, but instead represent only the Company’s beliefs regarding future events, plans or objectives, many of which, by their nature, are inherently uncertain and outside of Delic’s control. Generally, such forward-looking information or forward-looking statements can be identified by the use of forward-looking terminology such as ”plans”, ”expects” or “does not expect”, “is expected”, “budget”, “scheduled”, “estimates”, “forecasts”, “intends”, ”anticipates” or “does not anticipate”, or “believes”, or variations of such words and phrases or may contain statements that certain actions, events or results “may”, “could”, “would”, “might” or “will be taken”, “will continue”, ”will occur” or “will be achieved”. The forward-looking information and forward-looking statements contained herein may include, but are not limited to: information regarding the timing or terms upon which the Transaction will be completed; potential benefits of the Transaction; anticipated continued growth in the health and wellness sector (and, in particular, related to psychedelics); the ability of Delic to successfully achieve business objectives, and expectations for other economic, business, and/or competitive factors.
By identifying such information and statements in this manner, Delic is alerting the reader that such information and statements are subject to known and unknown risks, uncertainties and other factors that may cause the actual results, level of activity, performance or achievements of Delic to be materially different from those expressed or implied by such information and statements. Such risks and other factors may include, but are not limited to: risks and uncertainties relating to the Transaction not closing as planned or at all or on terms and conditions set forth in the Merger Agreement; incorrect assessment of the value and potential benefits of the Transaction; direct and indirect material adverse effects from the COVID-19 pandemic; inability to obtain future financing on suitable terms; failure to obtain required regulatory and other approvals; risks inherent in the psychedelic treatment sector; changes in applicable laws and regulations; and failure to comply with applicable laws and regulations.
In addition, in connection with the forward-looking information and forward-looking statements contained in this press release, Delic has made certain assumptions. These assumptions include, but are not limited to: assumptions as to the time required to negotiate a definite agreement and complete matters related to the Transaction; the ability to consummate the Transaction; the ability of the parties to obtain, in a timely manner, the requisite regulatory, corporate and other third party approvals and the satisfaction of other conditions to the consummation of the Transaction on the proposed terms; the potential impact of the announcement or consummation of the Transaction on relationships, including with regulatory bodies, employees, suppliers, customers and competitors; changes in general economic, business and political conditions, including changes in the financial markets; changes in applicable laws; compliance with extensive government regulation; and the diversion of management time on the Transaction.
Should one or more of these risks, uncertainties or other factors materialize, or should assumptions underlying the forward-looking information or statements prove incorrect, actual results may vary materially from those described herein as intended, planned, anticipated, believed, estimated or expected.
Although Delic believes that the assumptions and factors used in preparing, and the expectations contained in, the forward-looking information and statements are reasonable, undue reliance should not be placed on such information and statements, and no assurance or guarantee can be given that such forward-looking information and statements will prove to be accurate, as actual results and future events could differ materially from those anticipated in such information and statements. The forward-looking information and forward-looking statements contained in this press release are made as of the date of this press release, and Delic does not undertake to update any forward-looking information and/or forward-looking statements that are contained or referenced herein, except in accordance with applicable securities laws. All subsequent written and oral forward- looking information and statements attributable to Delic or persons acting on its behalf is expressly qualified in its entirety by this notice.
SOURCE Delic Holdings Corp
Investor Contact
Rich Rodriguez
Media Contact
MATTIO Communications
Noah Bethke
VANCOUVER, British Columbia, Dec. 02, 2021 (GLOBE NEWSWIRE) — KetamineOne Capital Limited (“Ketamine One” or the “Company”) (NEO: MEDI) (OTC: KONEF) (FRA: 6FC), a company focused on consolidating medical clinics and becoming a North American leader in mental health treatments, is pleased to announce that it is entering into a collaborative partnership with Cognetivity Neurosciences Ltd. (CSE: CGN; OTCQB: CGNSF; FWB: 1UB) (“Cognetivity”) to study and develop assessments for depression and post-traumatic stress disorder (“PTSD”).
In the initial stage of the partnership, Cognetivity and Ketamine One will partner on two separate clinical studies, one for depression and the second for PTSD. Protocols for both studies have received Institutional Review Board (“IRB”) approval and patient recruitment is expected to occur in early 2022. Ketamine One’s wholly owned subsidiary, KGK Science Inc., will lead the study, while Cognetivity will lead the analysis.
Ketamine One is a next-generation health and wellness company focused on transforming the treatment of mental health by providing ketamine-assisted therapy and psychedelic medicines. Based in Canada and operating clinics throughout North America, the firm is dedicated to building the critical infrastructure needed to provide potentially breakthrough and life-changing treatments for conditions such as anxiety, PTSD, chronic pain and addiction.
Cognetivity’s Integrated Cognitive Assessment (“ICA”) technology has already been deployed throughout Ketamine One’s network of clinics in North America after the two companies entered into a commercial agreement earlier this year. In the latest phase of their collaboration, the ICA will be used to monitor changes in patients’ cognitive ability as they undergo ketamine-assisted treatment for depression and PTSD.
The clinical studies will add to the extensive body of data validating the ICA’s use as a cognitive testing tool. It has already been widely deployed in clinical care, from North America and the Middle East to clinics in the UK’s National Health Service. The project will also generate novel intellectual property regarding the ICA’s predictive and long-term monitoring capabilities – not only on a stand-alone basis, but in combination with additional variables, including data from wearable devices, to support the creation of dedicated new products for specialist care in the areas of depression and PTSD.
It is well documented that there is vast potential for improvement in the treatment of such conditions. According to the World Health Organization, mental health disorders account for 28% of the global burden of disability-adjusted life years among non-communicable diseases – more than cardiovascular disease or cancer. Every year, more than 12 billion working days are lost due to mental health conditions, costing the global economy USD 16 trillion in economic output between 2011 and 2030. The global market for PTSD therapeutics is expected to reach USD 3.1 billion by 20271, with the global market for the treatment of anxiety disorders and depression predicted to exceed 13 billion by the same year2.
Management Commentary
“We’re delighted to be extending our relationship with Cognetivity through this exciting new research project,” said Adam Deffett, Interim CEO of Ketamine One. “Depression and PTSD are sadly very common conditions and existing approaches to treating them leave a lot to be desired. With the crucial involvement of the ICA, this study will further demonstrate the power of our therapies as we pursue our goal of changing how mental health is treated across North America.”
Also commenting on the announcement, Dr. Sina Habibi, CEO of Cognetivity, said, “It’s great to be working with Ketamine One on these clinical studies. We are very excited about obtaining high-quality clinical validation data on the use of the ICA to assess and monitor patients with depression and PTSD, and developing exciting new technology to better serve this huge market. These disease areas represent important use cases for the ICA beyond its core application as a device for dementia detection and diagnosis, and the fact that it can transition so smoothly into this new space confirms the strength of its fundamental capabilities and the ongoing global need for much-improved cognitive testing across a huge number of areas.”
ABOUT COGNETIVITY NEUROSCIENCES LTD.
Cognetivity is a technology company that has created a cognitive testing platform for use in medical, commercial and consumer environments. Cognetivity’s ICA uses Artificial Intelligence and machine learning techniques to help detect the earliest signs of cognitive impairment by testing the performance of large areas of the brain. The ICA is currently available for clinical use in the USA, UK and Europe, with regulatory approval for other regions planned for 2022.
For more information, please visit: www.cognetivity.com or contact: info@cognetivity.com.
ABOUT KETAMINE ONE
KetamineOne Capital Limited (formerly Myconic Capital Corp.) is a company focused on consolidating medical clinics and becoming a North American leader in mental health treatments. It is working to provide the critical infrastructure needed to develop and deliver breakthrough mental health treatments. Currently, Ketamine One has a network of clinics across North America, with plans to further consolidate the highly fragmented industry. KGK Science Inc. is the Company’s wholly owned contract research division, which places it at the forefront of premium clinical research based on the subsidiary’s history and extensive experience in pharmaceuticals, cannabis, and the emerging psychedelic medicine industries. As a collective enterprise, Ketamine One is dedicated to helping solve the growing need for safe and accessible mental health therapy.
On behalf of:
KETAMINE ONE
“Adam Deffett“
Adam Deffett, Interim CEO
For further information, please contact:
Nick Kuzyk, Investor Relations
Tel: 1-844-PHONE-K1 (1-844-746-6351)
Email: IR@ketamine.one
Web: www.ketamine.one
Twitter: @KetamineOne
Notice Regarding Forward-Looking Information:
This news release contains forward-looking statements including but not limited to statements regarding the Company’s business, assets or investments, as well other statements that are not historical facts. Readers are cautioned not to place undue reliance on forward-looking statements, as there can be no assurance that the plans, intentions or expectations upon which they are based will occur. By their nature, forward-looking statements involve numerous assumptions, known and unknown risks and uncertainties, both general and specific, that contribute to the possibility that the predictions, forecasts, projections and other forward-looking statements will not occur, which may cause 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. These assumptions, risks and uncertainties include, among other things, the state of the economy in general and capital markets in particular, investor interest in the business and prospects of the Company.
The forward-looking statements contained in this news release are made as of the date of this news release. Except as required by law, the Company disclaims any intention and assumes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by applicable securities law. Additionally, the Company undertakes no obligation to comment on the expectations of, or statements made, by third parties in respect of the matters discussed above.
Endnotes
If you’re interested in being a financial partner, clinic partner, or community advocate, we’d love to talk. partners@ketamine.one
TORONTO–(BUSINESS WIRE)– FSD Pharma Inc. (NASDAQ: HUGE) (CSE: HUGE) (FRA: 0K9) (“FSD Pharma” or the “Company”), a life sciences holding company dedicated to building a portfolio of assets and biotech solutions, announced today that it is sharing pre-clinical data, supported by an explanatory video, demonstrating the potentially disease-modifying effects of Lucid-MS, the Company’s lead drug candidate for the potential treatment of multiple sclerosis (“MS”), in the animal models of MS.
This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20211202005259/en/
Based on more than a decade of research, Lucid-MS is a patented neuroprotective new chemical entity (“NCE”) that affects protein citrullination and myelin structure, which are associated with the severity of MS lesions. In order to demonstrate the unique potential therapeutic value of this Lucid-MS, the Company has released a video explaining its pre-clinical results, including visual evidence of functional recovery on pre-clinical subjects, which can be accessed here. You can also access the video at www.fsdpharma.com.
The featured study uses an Experimental Autoimmune Encephalitis (“EAE”) mouse model, a commonly used immune-mediated mouse model of MS. MS is typically characterized as an autoimmune disease. Ten days following immunization with the antigen, mice received 1 milligram of Lucid-MS or saline (placebo). Test subjects were monitored for 50 days and were continually assessed for clinical symptoms; those that received Lucid-MS demonstrated an improvement in clinical score, compared with subjects that received placebo. For example, on Day 42, one of the Lucid-MS-treated subjects demonstrated functional recovery with a score of 0.5, compared with a score of 3 on Day 3 (lower clinical score indicates better condition of the subject), and by the end of the study, the subject showed clinical signs similar to those in a healthy mouse (as seen in the video).
“Lucid-MS has demonstrated the potential to prevent the degradation and help re-establish myelin which is evidenced by the functional recovery of mice as well as immunohistochemistry in this study, and several other studies in preclinical animal models,” said Dr. Lakshmi P. Kotra, Ph.D., Chief Executive Officer of Lucid Psycheceuticals Inc. (“Lucid”), FSD Pharma’s wholly-owned subsidiary. “This effect holds good promise for further development as a potential treatment for MS, and the biochemical mechanism of Lucid-MS represents a potential industry first in treating MS. We are eager to advance Lucid-MS to the clinic as quickly as we can.”
FSD Pharma is also advancing the development of its other drug candidates, including Lucid-PSYCH, a psycho-active molecule targeted to treat Major Depressive Disorder, and FSD-PEA, an anti-inflammatory compound.
About FSD Pharma
FSD Pharma Inc. is a biotechnology company with three drug candidates in different stages of development. FSD BioSciences, Inc. (“FSD BioSciences”) is focused on pharmaceutical research and development of its lead compound, ultra-micronized palmitoyl ethylamine (“PEA”) or FSD-PEA (formerly called FSD-201). Through the Company’s wholly owned subsidiary, Lucid, the Company is also focused on the research and development of its lead compounds, Lucid-PSYCH (formerly Lucid-201) and Lucid-MS (formerly Lucid-21-302). Lucid PSYCH is a molecular compound identified for the potential treatment of mental health disorders. Lucid-MS is a molecular compound identified for the potential treatment of neurodegenerative disorders.
Forward Looking Information
Certain statements contained herein are “forward-looking statements.” Often, but not always, forward-looking statement can be identified by the use of words such as “plans”, “expects”, “expected”, “scheduled”, “estimates”, “intends”, “anticipates”, “hopes”, “planned” or “believes”, or variations of such words and phrases, or states that certain actions, events or results “may”, “could”, “would”, “might”, “potentially” or “will” be taken, occur or be achieved. Forward-looking statements contained in this press release include the comments made with respect to the effects, value and advancement of the Company’s drug candidates, including the further development of drug candidates as a potential treatment for neurodegenerative and mental health disorders such as MS and Major Depressive Disorder, the significance of the Company’s drug candidates to the development of MS treatment in the industry and the Company’s expectations towards the advancement of its drug candidates to clinic. FSD cannot give any assurance that such forward-looking statements will prove to have been correct. The reader is cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release.
Since forward-looking statements relate to future events and conditions, by their very nature they require making assumptions and involve inherent risks and uncertainties. The Company cautions that although it is believed that the assumptions are reasonable in the circumstances, these risks and uncertainties give rise to the possibility that actual results may differ materially from the expectations set out in the forward-looking statements. Factors that may cause such material differences include without limitation: the fact that the drug development efforts of both Lucid and FSD BioSciences are at a very early stage; the fact that preclinical drug development is uncertain, and the drug product candidates of Lucid and FSD BioSciences may never advance to clinical trials; the fact that results of preclinical studies and early-stage clinical trials may not be predictive of the results of later stage clinical trials; the uncertain outcome, cost, and timing of product development activities, preclinical studies and clinical trials of Lucid and FSD BioSciences; the uncertain clinical development process, including the risk that clinical trials may not have an effective design or generate positive results; the potential inability to obtain or maintain regulatory approval of the drug product candidates of Lucid and FSD BioSciences; the introduction of competing drugs that are safer, more effective or less expensive than, or otherwise superior to, the drug product candidates of Lucid and FSD BioSciences; the initiation, conduct, and completion of preclinical studies and clinical trials may be delayed, adversely affected, or impacted by COVID-19 related issues; the potential inability to obtain adequate financing; the potential inability to obtain or maintain intellectual property protection for the drug product candidates of Lucid and FSD BioSciences; and other risks. Further information regarding factors that may cause actual results to differ materially are included in the Company’s annual and other reports filed from time to time with the Canadian Securities Administrators on SEDAR (www.sedar.com) and with the U.S. Securities and Exchange Commission on EDGAR (www.sec.gov) under the heading “Risk Factors.” Any forward-looking statement contained in this release speaks only as of its date. The Company does not undertake to update any forward-looking statements, except to the extent required by applicable securities laws.
View source version on businesswire.com: https://www.businesswire.com/news/home/20211202005259/en/
Zeeshan Saeed, President, Founder and Director, FSD Pharma Inc.
Email: Zsaeed@fsdpharma.com
Telephone: (416) 854-8888
Investor Relations: Email: FSDPharma@KCSA.com, skilmer@fsdpharma.com,
Website: www.fsdpharma.com
Source: FSD Pharma Inc.
Released December 2, 2021
Vancouver, B.C., December 2, 2021 – Pure Extracts Technologies Corp. (CSE: PULL) (OTC: PRXTF) (XFRA: A2QJAJ) (“Pure Extracts” or the “Company”), a plant-based extraction company focused on cannabis, hemp, functional mushrooms and the rapidly emerging psychedelic sector, is pleased to announce that its wholly owned subsidiary, Pure Extracts Manufacturing Corp., has shipped another order of vape carts via its distribution partner, Abba Medix, to the British Columbia Liquor Distribution Branch (LDB), the sole wholesale distributor of non-medical cannabis in the province.
These 1.0 gram vapes are selling out on-schedule and the Company has consistently been able to fulfill regular, follow-on purchase orders (POs) on time and in the quantities requested by the LDB.
The Pure Pulls branded vape cartridges were filled with a selection of some of the Company’s 30+ proprietary cannabis full-spectrum oil (FSO) formulations including Grand Daddy Purple and GSC.
Pure Extracts CEO, Ben Nikolaevsky, remarked, “We are pleased to be expanding our sales and brand awareness in our home province of British Columbia. The repeat orders we have shipped to the LDB underscore the high-quality of our products and the reliability of our manufacturing processes.”
ON BEHALF OF THE BOARD
“Ben Nikolaevsky”
Ben Nikolaevsky
CEO and Director
About Pure Extracts (CSE: PULL) (OTC: PRXTF) (XFRA: A2QJAJ)
Pure Extracts Technology Corp. features an all-new, state-of-the-art processing facility located just 20 minutes north of world-famous Whistler, British Columbia. The bespoke facility has been constructed to European Union GMP standards aiming towards export sales of products and formulations, including those currently restricted in Canada, into European jurisdictions where they are legally available. Pure Extracts was granted its Standard Processing License by Health Canada under the Cannabis Act on September 25, 2020, and its Sales Amendment on July 19, 2021. The Company’s stock began trading on the Canadian Securities Exchange (CSE) on November 5, 2020.
Find out more at https://pureextractscorp.com/
Or contact:
Pure Extracts Investor Relations
Tel: +1 604 493 2052
info@pureextractscorp.com
ON BEHALF OF THE BOARD
“Ben Nikolaevsky”
Ben Nikolaevsky
CEO and Director
This news release contains forward-looking statements relating to the future operations of Pure Extracts,
and the other statements are not historical facts. Forward-looking statements are often identified by terms such as “will”, “may”, “should”, “anticipate”, “expects” and similar expressions. All statements other than statements of historical fact, included in this release, including, without limitation, statements regarding the future plans and objectives of Pure Extracts’, are forward-looking statements and involve risks and uncertainties. A number of factors could cause actual events, performance or results to differ materially from what is projected in forward looking statements. Although we believe that the assumptions underlying these statements are reasonable, they may prove to be incorrect, and we cannot assure that actual results will be consistent with these forward-looking statements. Given these risks, uncertainties and assumptions, investors should not place undue reliance on these forward-looking statements. Whether actual results, performance or achievements will conform to the Company’s expectations and predictions is subject to a number of known and unknown risks, uncertainties, assumptions and other factors, including those listed under “Risk Factors” in the Company’s Annual Information Form. The Company does not undertake to update any forward-looking information, except as, and to the extent required by, applicable securities laws.
This news release contains information about potential sales revenue from supply agreements, which may be considered as disclosure of financial outlook under applicable securities laws. Such information is subject to the same assumptions, risk factors, limitations, and qualifications as set forth in the above paragraph. Specifically, estimated sales revenue which may be derived from supply contracts has been calculated based on current wholesale prices and assume, among other things, that the Company will be able to find buyers for its products. The financial outlook contained in this news release was made by management as of the date of this news release and was provided for the purpose of providing readers with an understanding of the potential revenue which may be derived from any agreements recently entered into by the Company and are not an estimate of profitability or any other measure of financial performance. Readers are cautioned that the financial outlook contained in this document should not be used for purposes other than for which it is disclosed herein.
The CSE has neither approved nor disapproved the contents of this press release.
COMPASS Pathways (CMPS) announced additional findings from the world’s largest psilocybin trial for depression.
In addition to reduced depression scores, patients showed improvements in anxiety, daily functioning, cognition, and quality of life. Just one day after the treatment, patients had increased positive feelings such as “interested, excited, strong” and decreased negative feelings like “distressed, upset, afraid.”
COMPASS Pathways plc (Nasdaq: CMPS) (“COMPASS”), a mental health care company dedicated to accelerating patient access to evidence-based innovation in mental health, today announced further results from its groundbreaking phase IIb clinical trial of COMP360 psilocybin therapy for treatment-resistant depression (TRD). Additional analyses of primary and secondary endpoints validated topline findings and provided more insights into safety data. Analyses of exploratory measures including anxiety, self-reported depression, positive and negative affect, and functioning, showed greater improvements for patients receiving a 25mg dose of COMP360 psilocybin compared with those receiving a 1mg dose after three weeks, both with psychological support. Further analysis is ongoing and full trial results will be submitted for publication in a peer-reviewed journal. The data will be reviewed with regulators early next year. The objective of the trial was to find the appropriate dose for a larger, pivotal phase III programme, which COMPASS expects to begin in 2022.
Professor Guy Goodwin, Chief Medical Officer, COMPASS Pathways, said: “Our additional analyses underline the robustness of our findings that a single high dose of COMP360 psilocybin, given in conjunction with psychological support, led to a rapid and sustained response for many patients. This phase IIb study was designed to determine the optimal COMP360 dose for our phase III programme, evaluating safety and efficacy at the primary endpoint at week 3. Additionally, we observed consistent improvement in measures of anxiety, positive and negative affect, quality of life, daily functioning, cognition, and self-reported depression. We believe this could make a tremendous difference to patients suffering with treatment-resistant depression, who have few options available to them. Remember, a quarter of the 25mg group maintained response, as measured by the MADRS, at 12 weeks after a single administration with no other antidepressant medication. This finding in itself is unprecedented.”
COMPASS reported topline data from this trial last month, which investigated three doses of COMP360 psilocybin (1mg, 10mg, 25mg) in 233 patients with TRD. The results showed that a single 25mg dose of COMP360 demonstrated a highly statistically significant and clinically relevant reduction in depressive symptom severity after three weeks, with a rapid and durable treatment response. The 25mg group vs the 1mg group showed a -6.6 difference on the MADRS* depression scale at week 3 (p<0.001). In the 25mg group, 36.7% (29 patients) showed response* at week 3 and 29.1% (23 patients) were in remission* at week 3. Furthermore, at the end of the trial at week 12, 24.1% (19 patients) were sustained responders*. Additional analyses of primary and secondary endpoints have supported these results.
As well as looking at clinician-rated depression severity on the MADRS, the trial explored other aspects which are recognised as being important for patients with TRD – and essential to recovery – including positive and negative affect, anxiety, self-rated depression severity, quality of life, functioning and cognition. These exploratory measures also showed that patients in the 25mg dose group of COMP360 psilocybin therapy reported benefits on those measures over those in the 1mg group. On the PANAS* scale measuring positive and negative affect, patients in the 25mg group had a higher increase in positive affect (eg including feeling interested, excited, strong) and a greater decrease in negative affect (eg including feeling distressed, upset, afraid) on the day after COMP360 administration and at the questionnaire’s final administration at week 3. On scales measuring anxiety (GAD-7*), self-rated depression (QIDS-SR-16*) and functioning (SDS* and WSAS*), a greater improvement was also shown at week 3, by patients in the 25mg group compared with the 1mg group.
A post-hoc analysis of the 19 sustained responders in the 25mg group found that changes in quality of life, self-reported depression severity, and functioning, were clinically meaningful, with mean scores for these patients returning to “normal” levels and maintained to 12 weeks, the end of the trial. Durability is being studied in a one-year follow-up study which is currently underway.
As noted in the topline data reported last month, COMP360 psilocybin was generally well-tolerated. Further analysis showed that there were no concerns with vital signs, ECG or clinical laboratory data in any of the treatment groups. The majority of treatment-emergent adverse events (TEAEs) occurring on the day of COMP360 administration resolved on the same day or the day after (77.4%); most of these events were mild or moderate in nature, eg headache, nausea, fatigue. All TEAEs involving hallucination (which only occurred in the 25mg and 10mg groups) and illusion (which occurred in all groups) started on the day of administration and resolved on the same day. No events of this nature continued past the administration day.
TEAEs of suicidal ideation, suicidal behaviour and intentional self-injury were seen in all groups, as is regularly observed in a TRD population. Two thirds of the patients had previous thoughts of wishing to be dead, as assessed by a suicidality scale completed during patient screening; this included all patients reporting one of these adverse events, so all patients who experienced these events during the trial had said in patient screening that they had had suicidal thoughts prior to the trial. Further detailed case-by-case analysis of safety data found no evidence to suggest, at this time, a causal relationship between these reported adverse events and administration of COMP360. The events occurred in all treatment groups and at a range of onset times and durations; the majority occurred more than a week after the psilocybin session.
Professor Goodwin said: “Further understanding of the timing and circumstance of adverse events in the trial demonstrates that COMP360 psilocybin therapy was generally well-tolerated. More detailed analysis of the safety data supports our conclusion that there is no evidence to date to suggest a causal relationship between the serious adverse events of suicidal ideation, suicidal behaviour and self-injury, and administration of COMP360 psilocybin therapy. Unfortunately, these events occur unpredictably and are to be expected in this patient population.”
He continued: “We are now taking all the data we have generated and using it to inform our clinical development programme so we can understand which patients we might be able to help and how we might help more of them. We will be discussing this with regulators early next year as part of our ongoing dialogue with them.”
Sidney Zisook MD, Director of the University of California San Diego Residency Training Program, a Distinguished Professor of Psychiatry at UCSD, and a Principal Investigator on the trial, said: “Many of the participants in this study had suffered for years with severe and crippling depressive disorders despite multiple treatment trials with traditional antidepressant medications and therapies. To see so many experience a robust and sometimes persisting response – and a new, brighter, more positive attitude – during the course of the study, was immensely gratifying and hopeful.”
Further detail on additional findings from exploratory measures
More than 320 million people globally suffer with major depressive disorder (MDD)[1], the leading cause of disability worldwide and one of the fastest growing mental health illnesses[2]. About a third of these patients – 100 million people – aren’t helped by existing therapies and suffer with treatment-resistant depression (TRD)[3]. As many as 30% of these attempt suicide at least once during their lifetime[4],[5]. TRD carries two to three times the medical costs of a non-TRD MDD patient, and patients with TRD have a higher all-cause mortality compared with non-TRD MDD patients[6]. The TRD population is by definition more difficult to treat and more likely to relapse than patients with major depressive disorder. In 2018, COMPASS received FDA Breakthrough Therapy designation for its COMP360 psilocybin therapy for TRD.
This randomised, controlled, multicentre, double-blind phase IIb trial is the largest psilocybin therapy clinical trial ever conducted, with 233 patients from 10 countries in North America and Europe. 94% of the patients had no prior experience with psilocybin. The objective of the trial was to find the appropriate dose for a larger, pivotal phase III programme, which COMPASS expects to begin in 2022.
The trial assessed the safety and efficacy of COMP360 psilocybin therapy at three doses: 1mg, 10mg, 25mg. A total of 233 patients enrolled in the study and were randomised and blinded into three arms comprising 79 patients for each of the 25mg and 1mg doses, and 75 patients for the 10mg dose. Patients were followed up for 12 weeks. The trial used the Montgomery-Åsberg depression rating scale (MADRS), a widely used and accepted scale for assessing depression; assessments were made by an independent, blinded rater. The primary endpoint was the change in the MADRS total score from baseline to week 3.
COMPASS Pathways plc (Nasdaq: CMPS) is a mental health care company dedicated to accelerating patient access to evidence-based innovation in mental health. Our focus is on improving the lives of those who are suffering with mental health challenges and who are not helped by current treatments. We are pioneering the development of a new model of psilocybin therapy, in which our proprietary formulation of synthetic psilocybin, COMP360, is administered in conjunction with psychological support. COMP360 has been designated a Breakthrough Therapy by the US Food and Drug Administration (FDA), for treatment-resistant depression (TRD), and we have completed a phase IIb clinical trial of psilocybin therapy for TRD, in 22 sites across Europe and North America. This was the largest randomised, controlled, double-blind psilocybin therapy clinical trial ever conducted, and our topline data showed a statistically significant (p<0.001) and clinically relevant improvement in depressive symptom severity after three weeks for patients who received a single high dose of COMP360 psilocybin with psychological support. We are also running a phase II clinical trial of COMP360 psilocybin therapy for post-traumatic stress disorder (PTSD). COMPASS is headquartered in London, UK, with offices in New York and San Francisco in the US. Our vision is a world of mental wellbeing. www.compasspathways.com
Investors and others should note that we communicate with our investors and the public using our website (www.compasspathways.com), our investor relations website (ir.compasspathways.com), and on social media (LinkedIn), including but not limited to investor presentations and investor fact sheets, US Securities and Exchange Commission filings, press releases, public conference calls and webcasts. The information that we post on these channels and websites could be deemed to be material information. As a result, we encourage investors, the media, and others interested in us to review the information that is posted on these channels, including the investor relations website, on a regular basis. This list of channels may be updated from time to time on our investor relations website and may include additional social media channels. The contents of our website or these channels, or any other website that may be accessed from our website or these channels, shall not be deemed incorporated by reference in any filing under the Securities Act of 1933.
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. In some cases, forward-looking statements can be identified by terminology such as “may”, “might”, “will”, “could”, “would”, “should”, “expect”, “intend”, “plan”, “objective”, “anticipate”, “believe”, “contemplate”, “estimate”, “predict”, “potential”, “continue” and “ongoing,” or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. Forward-looking statements include express or implied statements relating to, among other things, the safety or efficacy of COMP360 psilocybin therapy as a treatment for depression, COMPASS’s expectations for the timing of its pivotal phase III programme and the potential for that or other trials to support regulatory filings and approvals, COMPASS’s business strategy and goals, the future accessibility of COMP360 psilocybin therapy, COMPASS’s ability to continue to advance its research, including COMP360, COMPASS’s expectations regarding the benefits of its psilocybin therapy, including COMP360 and COMPASS’s ability to advance new psychedelic compounds in other areas of unmet mental health need. The forward-looking statements in this press release are neither promises nor guarantees, and you should not place undue reliance on these forward-looking statements because they involve known and unknown risks, uncertainties, and other factors, many of which are beyond COMPASS’s control and which could cause actual results, levels of activity, performance or achievements to differ materially from those expressed or implied by these forward-looking statements.
These risks, uncertainties, and other factors include, among others: preclinical research and clinical development is lengthy and uncertain, and therefore our preclinical studies and clinical trials may be delayed or terminated, or may never advance to or in the clinic; and those risks and uncertainties described under the heading “Risk Factors” in COMPASS’s annual report on Form 20-F filed with the US Securities and Exchange Commission (SEC) on 9 March 2021 and in subsequent filings made by COMPASS with the SEC, which are available on the SEC’s website at www.sec.gov. Except as required by law, COMPASS disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this press release in the event of new information, future developments or otherwise. These forward-looking statements are based on COMPASS’s current expectations and speak only as of the date hereof.
Media: Tracy Cheung, tracy@compasspathways.com, +44 7966 309024
Investors: Stephen Schultz, stephen.schultz@compasspathways.com, +1 401 290 7324
*Notes: MADRS = Montgomery-Åsberg Depression Rating Scale; response = ≥50% decrease in MADRS total score from baseline; remission = MADRS total score ≤10; sustained response = patients meeting the MADRS response criteria at week 3 and at week 12, and at least at one visit out of week 6 and week 9, and who did not start new treatment for depression during the study; PANAS = Positive and Negative Affect Schedule; GAD-7 = Generalised Anxiety Disorder – 7 item; QIDS-SR-16 = Quick Inventory of Depressive Symptomatology, self-rated, 16-item; SDS = Sheehan Disability Scale; WSAS = Work and Social Adjustment Scale
[1] WHO (2017). Depression and Other Common Mental Disorders Global Health Estimates [Online]. Available at: https://apps.who.int/iris/bitstream/handle/10665/254610/WHO-MSD-MER-2017.2-eng.pdf [Accessed 21 October 2021]
[2] WHO (2012). Depression: A Global Crisis [Online]. Available at: https://www.who.int/mental_health/management/depression/wfmh_paper_depression_wmhd_2012.pdf [Accessed 21 October 2021]
[3] Al-Harbi KS. Treatment-resistant depression: therapeutic trends, challenges, and future directions. Patient Preference and Adherence. 2012; 6: 369–388.
[4] Bergfeld IO, Mantione M, Figee M, Schuurman PR, Lok A, Denys D. Treatment-resistant depression and suicidality. Journal of Affective Disorders. 2018;235:362-367
[5] Dong M, Lu L, Zhang L, et al. Prevalence of suicide attempts in bipolar disorder: a systematic review and meta-analysis of observational studies. Epidemiology and Psychiatric Sciences. 2020;29:e63
[6] Gang L, Fife D, Wong G, Sheehan JJ, et al. All-cause mortality in patients with treatment-resistant depression: a cohort study in the US population. Annuals of General Psychiatry. 2019; 18:23.
Toronto, Ontario – November 30, 2021 – PharmaDrug Inc. (CSE: PHRX) (OTCQB: LMLLF) (“PharmaDrug” or the “Company“), a specialty pharmaceutical company focused on the research, development and commercialization of controlled-substances and natural medicines such as psychedelics, cannabis and naturally-derived approved drugs, is pleased to announce the successful completion of its Type B pre-IND meeting with the U.S. Food and Drug Administration (FDA), for which a pre-IND briefing package and meeting request letter was submitted in September 2021. The FDA has provided written responses to the Company regarding its clinical development plan for PD-001, a patented enteric-coated formulation of cepharanthine, as a potential oral antiviral pill for COVID-19. PharmaDrug believes the written response provides a path to agreements on IND-enabling studies, the design of a Phase 1/2 clinical study, and the overall clinical development plan to move PD-001 forward as an oral treatment for COVID-19. By extension, the FDA guidance also provides important insights on advancing PD-001 as a potential treatment for oncology indications as part of the Company’s ongoing strategy of targeting rare and life-threatening conditions. The Company continues to focus on completing the remaining IND-enabling studies to support future clinical studies in 2022.
As the pandemic has evolved rapidly, so too have the FDA’s views and requirements on what pre-clinical and non-clinical data sets will be necessary to support initiation of a first in human clinical trial for COVID-19. In written responses to the questions provided by the Company, the FDA addressed PharmaDrug’s questions related to manufacturing, safety/toxicology, pre-clinical efficacy studies, clinical trial design, and rationale necessary to support subsequent human clinical trials. The feedback provides the Company with greater clarity on the current requirements needed to file an IND to initiate a Phase 1/2 clinical trial of PD-001 in patients with COVID-19. Based upon the historical clinical data for generic cepharanthine and the Company’s preclinical testing performed on PD-001 thus far, PharmaDrug anticipates filing an IND in the second half of 2022. In addition, PharmaDrug intends to pursue FDA Expedited Programs, such as Breakthrough Designation pending the development of preliminary clinical evidence to support such designation.
PharmaDrug intends to advance its IND-enabling activities for PD-001 as follows based on the written response it recently received from the FDA:
Following FDA feedback, the Company plans to continue the development of PD-001 for COVID-19. The Company will be conducting several nonclinical safety, toxicology, virology assessments, as well as scale-up of drug product manufacturing. The currently described work is necessary to bring PD-001 to the clinic for COVID-19 and is highly complementary to the safety/tox/manufacturing efforts already underway for its cepharanthine program in oncology.
“The FDA’s response to our recent pre-IND submission will allow us to be efficient and systematic about completing the remaining activities necessary to safely transition our cepharanthine program from pre-clinical into full clinical evaluation as a novel, oral antiviral to treat COVID-19. The continued emergence of COVID-19 variants, including the recent Omicron variant, some of which may eventually evolve to evade the protection afforded by existing vaccines, underscores an urgent need to develop an effective and diverse arsenal of orally active antiviral medications,” said Dr Van Slyke, Chief Scientific Officer of PharmaDrug.
The Company would like to make it clear that is not making any express or implied claims that its product (cepharanthine) has the ability to treat, eliminate or cure COVID-19 (SARS-CoV-2) and/or other infectious diseases at this time.
Cepharanthine For COVID-19
Approved for more than 70 years in Japan, cepharanthine has been used safely and effectively to treat a variety of acute and chronic diseases. To date, several third party validated library screens of approved and investigational drugs have identified cepharanthine as a forerunner candidate molecule in the treatment SARS-CoV-2, the virus that causes COVID-191,2,3. In fact, cepharanthine has now been shown to be highly effective at blocking cell death following exposure to multiple different coronaviruses, including COVID-19, lab-attenuated SARS-CoV (original SARS) and the virus that causes Middle East respiratory syndrome (MERS)1,2,3. In November 2021 an independent research group examined the potential of cepharanthine to limit the cytopathic effects of the South African COVID-19 variant, B.1.3514. It was found that cepharanthine was at least 6-times more active against the South African variant strain than original SARS-CoV-2, and that cepharanthine was the most effective of all the drugs used in the in vitro screen that was perfomed4. Although the recent Omicron variant discovered in South African nations shares several features in common with the previous South African variant, B.1.351, it remains to be determined how well cepharanthine will perform at treating this emerging threat. Despite the promising findings for cepharanthine noted above, translation into clinical application has thus far been hampered by the need for the generic formulation of the drug to be delivered by intravenous due to its intrinsically poor oral bioavailability. As such, it is believed that the Company’s novel oral formulation of cepharanthine, PD-001 would be an ideal candidate to evaluate as a potential treatment for mild to moderate COVID-19. By leveraging its exclusive rights to U.S. Patent: 10,576,077, titled “Pharmaceutical Salt forms of Cepharanthine and Tetrandrine”, PharmaDrug intends to develop and commercialize PD-001 as an oral antiviral treatment for patients with mild to moderate SARS-CoV-2 infection.
How Cepharanthine May Work to Block Coronavirus Entry
In a recent peer reviewed manuscript cepharanthine was shown to display greater antiviral potency against SARS-CoV-2 than existing clinical development candidates remdesivir, lopinavir, favipiravir, nelfinavir and chloroquine1. Researchers identified a putative binding site on the surface of SARS-CoV-2 spike protein known to facilitate viral docking with the human ACE2 receptor. Consistent with this mechanism of action, application of cepharanthine to cells exposed to SARS-CoV-2 fully blocked viral internalization and subsequent production of viral particles 24 hours post infection1.
About PD-001 (Enteric-coated Cepharanthine)
Cepharanthine is a natural product and an approved drug used for more than 70 years in Japan to successfully treat a variety of acute and chronic diseases. In clinical research, Cepharanthine has been shown to exhibit multiple pharmacological properties including anti-oxidative, anti-inflammatory, immuno-regulatory, anti-cancer, anti-viral and anti-parasitic effects5,6. However, historically cepharanthine’s low oral bioavailability has represented a major obstacle to realizing its full clinical potential.
The Company is focused on advancing the clinical development of an improved oral formulation of cepharanthine (PD-001) to treat rare cancers and COVID-19. Compared to generic cepharanthine, PD-001 has been shown in rodent and non-rodent models to possess markedly superior bioavailability (more easily absorbed). These findings support the development of an orally administered formulation, and in so doing, removes the undesirable requirement for frequent intravenous dosing.
About PharmaDrug Inc.
PharmaDrug is a specialty pharmaceutical company focused on the research, development and commercialization of controlled-substances and natural medicines such as psychedelics, cannabis and naturally-derived approved drugs. PharmaDrug owns 100% of Pharmadrug Production GmbH (“Pharmadrug Production”), a German medical cannabis distributor, with a Schedule I European Union narcotics license and German EuGMP certification allowing for the importation and distribution of medical cannabis to pharmacies in Germany and throughout the European Union. PharmaDrug recently acquired Sairiyo Therapeutics (“Sairiyo”), a biotech company that specializes in researching and reformulating established natural medicines with a goal of bringing them through clinical trials and the associated regulatory approval process in the US and Europe. Sairiyo is currently developing its patented reformulation of cepharanthine, a drug that has shown substantial third party validated potential for the treatment of COVID-19 and rare cancers. Sairiyo is also conducting R&D in the psychedelics space for the treatment of non-neuropsychiatric conditions. The Company also owns 100% of Super Smart, a company building a vertically integrated retail business with the goal to elevate the use of functional mushrooms, and psilocybin mushrooms where federally legal, as natural based medicines.
For further information, please contact:
Daniel Cohen, Chairman and CEO
dcohen@pharmadrug.co
(647) 202-1824
Caution Regarding Forward-Looking Information:
THE CANADIAN SECURITIES EXCHANGE HAS NOT REVIEWED NOR DOES IT ACCEPT RESPONSIBILITY FOR THE ADEQUACY OR ACCURACY OF THIS RELEASE.
This press release contains “forward-looking information” within the meaning of applicable securities legislation. All statements, other than statements of historical fact, included herein are forward-looking information. Generally, forward-looking information may be identified by the use of forward-looking terminology such as “plans”, “expects” or “does not expect”, “proposed”, “is expected”, “budgets”, “scheduled”, “estimates”, “forecasts”, “intends”, “anticipates” or “does not anticipate”, or “believes”, or variations of such words and phrases, or by the use of words or phrases which state that certain actions, events or results may, could, would, or might occur or be achieved. In particular, this press release contains forward-looking information in relation to: the development and commercialization of cepharanthine, the results of the Company’s research and development in the psychedelics space and the development of the Supersmart business . This forward-looking information reflects the Company’s current beliefs and is based on information currently available to the Company and on assumptions the Company believes are reasonable. These assumptions include, but are not limited to the ability of the Company to successfully execute on its plans for the Company and its affiliated entities; the ability to obtain required regulatory approvals and the Company’s continued response and ability to navigate the COVID-19 pandemic being consistent with, or better than, its ability and response to date.
Forward-looking information is subject to known and unknown risks, uncertainties and other factors that may cause the actual results, level of activity, performance or achievements of the Company to be materially different from those expressed or implied by such forward-looking information. Such risks and other factors may include, but are not limited to: general business, economic, competitive, political and social uncertainties; general capital market conditions and market prices for securities; the actual results of the Company’s future operations; competition; changes in legislation affecting the Company; the ability to obtain and maintain required permits and approvals, the timing and availability of external financing on acceptable terms; lack of qualified, skilled labour or loss of key individuals; risks related to the COVID-19 pandemic including various recommendations, orders and measures of governmental authorities to try to limit the pandemic, including travel restrictions, border closures, non-essential business closures, service disruptions, quarantines, self-isolations, shelters-in-place and social distancing, disruptions to markets, economic activity, financing, supply chains and sales channels, and a deterioration of general economic conditions; and a deterioration of financial markets that could limit the Company’s ability to obtain external financing.
A description of additional risk factors that may cause actual results to differ materially from forward-looking information can be found in the Company’s disclosure documents on the SEDAR website at www.sedar.com. Although the Company has attempted to identify important factors that could cause actual results to differ materially from those contained in forward-looking information, there may be other factors that cause results not to be as anticipated, estimated or intended. Accordingly, readers should not place undue reliance on forward-looking information. Readers are cautioned that the foregoing list of factors is not exhaustive. Readers are further cautioned not to place undue reliance on forward-looking information as there can be no assurance that the plans, intentions or expectations upon which they are placed will occur. Such information, although considered reasonable by management at the time of preparation, may prove to be incorrect and actual results may differ materially from those anticipated.
The Company’s securities have not been registered under the U.S. Securities Act of 1933, as amended (the “U.S. Securities Act”), or applicable state securities laws, and may not be offered or sold to, or for the account or benefit of, persons in the United States or “U.S. Persons”, as such term is defined in Regulations under the U.S. Securities Act, absent registration or an applicable exemption from such registration requirements. 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 the United States or any jurisdiction in which such offer, solicitation or sale would be unlawful.
Forward-looking information contained in this press release is expressly qualified by this cautionary statement. The forward-looking information contained in this press release represents the expectations of the Company as of the date of this press release and, accordingly, are subject to change after such date. However, the Company expressly disclaims any intention or obligation to update or revise any forward-looking information, whether as a result of new information, future events or otherwise, except as expressly required by applicable securities law.
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TORONTO, ONTARIO Nov. 29, 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 second-quarter results for the three-month period ending September 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.
“We have made tremendous progress on our strategic priorities, including increasing access to novel treatments for patients with depression through our clinics. We have also established a clinical research infrastructure required to execute on our growing pipeline of registered clinical trials alongside third-party sponsors, with 14 trials registered to date in the area of depression, including Canada’s first and only psilocybin trial actively recruiting study participants to receive psilocybin-assisted therapy,” said Dr. Roger McIntyre, CEO, Braxia Scientific.
“Looking ahead to our clinical research and development, our psilocybin trial is underway with newly trained therapists. These therapists have the required skills to execute a successful psilocybin-assisted therapy trial while ensuring patients receive treatments according to approved protocols and best practices – critical milestones that will create near-term value for Braxia Scientific in terms of patient access, drug development and implementation. While our product development pipeline is at an early stage, we have made progress in our goal to develop new ketamine derivatives and delivery formats underpinned by our large proprietary health database from administering ~4,900 ketamine treatments to date at our clinics.”
“We continue to prioritize the expansion of our clinical footprint in Canada. We remain disciplined in our growth efforts and continue to actively assess a strong pipeline of opportunities to scale access to ketamine treatments for patients in North America.”
Building on management’s extensive clinical expertise, the Company has expanded the necessary infrastructure to provide novel interventions that include ketamine, psilocybin and other potential future psychedelics that become available.
More specifically, the Company infrastructure has:
This infrastructure enables Braxia Scientific to provide psilocybin-assisted therapy as part of the current clinical trial, and importantly, if psilocybin is approved in the future, Braxia Scientific is positioned to provide access to psilocybin-assisted therapy treatment for eligible patients immediately.
Fourteen (14) Clinical Trials Including Landmark Multi-Dose Psilocybin Study: Dr. Joshua Rosenblat, Chief Medical and Scientific Officer for Braxia Scientific, recently commenced a landmark clinical trial to conduct Canada’s first multiple-dose controlled psilocybin study for treatment-resistant depression (TRD). Through this trial, patients will be able to receive immediate access to psilocybin and be monitored by therapists with specialized training in psilocybin-assisted therapy. Whereas most other TRD studies limit participation to patients that have not found relief from a maximum of five other potential remedies, this trial does not impose an upper limit, and allows for patients that have endured dozens of unsuccessful medical treatments, including with ketamine and electroconvulsive therapy.
Developing the Next Generation of Clinicians: The Braxia Institute, the Company’s training centre focused on advancing psychiatric clinical practice and health services of ketamine and psychedelic treatment therapy, is set to graduate the first cohort of medical professionals from its psilocybin-assisted therapy training program. This multidisciplinary group of 20 therapists from diverse psychiatry and psychotherapy backgrounds experienced and learned, through pre-readings, didactic teaching, peer teaching, group discussion and simulations, which provided important background on the use of psilocybin for treating depression and practical considerations for providing psilocybin-assisted psychotherapy. All the enrolled therapists are also required to complete a practicum component, in which medical professionals gain experience in administering psilocybin-assisted therapy for participants with depression as part of an upcoming Health Canada-approved clinical trial.
The Company anticipates that, subject to the regulatory approval of psilocybin, therapists would also be trained to implement psychedelics in clinical practice.
Growing Proprietary Ketamine Research Database: As the Company continues to focus on developing novel ketamine derivatives, Braxia Scientific’s team of researchers also continue to carry out multiple research trials adding to the Company’s large database of proprietary data critical to future drug development efforts.
The Canadian Rapid Treatment Centre of Excellence (CRTCE), a wholly owned Braxia subsidiary, has comprehensive health data from administering approximately 4,900 ketamine treatments at CRTCE clinics. Braxia Scientific’s researchers have published 39 ketamine-related manuscripts in peer-reviewed biomedical journals.
During the quarter, the Company reported encouraging preliminary findings of an important ketamine clinical study that suggest ketamine may be as effective as a standalone antidepressant, versus as an adjunctive therapy. The study, which was conducted at the CRTCE, showed comparable clinical benefits (e.g., antidepressant effects and reduction in suicidal thoughts) in a sample of 220 patients with treatment-resistant depression (TRD) who received intravenous (IV) ketamine infusions as a monotherapy, as compared with those receiving IV ketamine in addition to oral antidepressants.
Following the study protocols, participants in the ketamine monotherapy group achieved response and remission rates of 39.1% and 17.4%, respectively. Meanwhile, those receiving ketamine treatment adjunct to antidepressants, saw corresponding rates of 21.9% and 6.7%.
These initial findings support ketamine’s effectiveness as a rapid-acting antidepressant treatment approach as evidenced by its ability to improve depression as a monotherapy, and the data is particularly important, because it shows that the benefits of ketamine may not be dependent on the co-prescription of other medications.
Publishing timely studies: Braxia Scientific was pleased to announce the publication of a new analysis led by the Company’s CEO, Dr. Roger McIntyre, in the Journal of the Royal Society of Medicine. The study, which showed a decrease in the Canadian suicide mortality rate during the first year of the COVID-19 pandemic, was initiated to evaluate the impact on national suicide rates in Canada of federal, public health and social support programs that were put in place to mitigate the coinciding abrupt changes to social and financial provisions. The findings also underscore Braxia Scientific’s core objective to develop derivatives of ketamine and other psychedelics as additional measures to further reduce suicidality.
Growing Canadian Patient Treatments: To accommodate increasing demand for ketamine treatments, the Company expects to commence expansion of its existing clinics in Toronto and Ottawa in the coming months, as well as ramp up personnel at its existing clinics. Through its four multidisciplinary, community-based Canadian clinics, the Company continues to see increased patient referrals and treatments which led to a year-over-year increase in revenue of nearly 55% in the second quarter of fiscal 2022.
North American Clinic Expansion: Following the publication by the American Journal of Psychiatry of the international guidelines and best practices for clinicians on the use of IV ketamine, which is based on research conducted by the Company’s research team, including CEO Dr. Roger McIntyre and Chief Medical and Scientific Officer Dr. Joshua Rosenblat, at CRTCE, the Company remains focused on expanding its clinical footprint beyond Canada into the U.S. and Europe. The Company continues to be disciplined in deploying capital towards acquisition initiatives.
Cultivating Name Recognition: Braxia Scientific was featured in recent national and local news coverage, discussing access and promoting the use of ketamine to treat brain-based illnesses, bolstering the Company’s brand awareness. Braxia Scientific CEO Dr. Roger McIntyre was featured on CTV’s W5, Canada’s most-watched current affairs and documentary program. The episode, entitled “Psychedelic Healing,” aired on October 23, 2021.
Braxia Scientific and the CRTCE were also highlighted in a recent article by Toronto Life, a monthly magazine. In the piece, Dr. McIntyre and Dr. Rosenblat discussed the benefits of ketamine therapy to rapidly treat mental disorders like treatment-resistant depression (TRD) and the access to the treatments Braxia Scientific provides through its clinics.
The Company’s cash and cash equivalents as of September 30, 2021, was $9,614,977, compared with $10,257,750 at June 30, 2021.
The Company recorded revenue of $385,525 for the second quarter fiscal 2022, ended September 30, 2021 compared with revenue of $249,049 in the second quarter ended September 30, 2020, reflecting 54.8% increase year-over-year. Second quarter 2022 gross margin was $57,140, compared with $3,603 in the prior year period. Revenues consisted primarily of sales from the administering of ketamine infusion treatments at the CRTCE clinics in Ontario.
Net loss for the quarter decreased 16%, to $1,709,942 including a non-cash share-based compensation expense of $821,748, compared to a net loss of $2,052,580 in the second quarter of the prior year period.
“Braxia Scientific’s value proposition rests in our superior human capital, well established clinical infrastructure and large proprietary health database,” said Dr. McIntyre. “Our team includes three researchers ranked among the world’s top 25 in depression, as well as mood disorders research. Having conducted or registered 14 clinical trials for depression, we believe Braxia Scientific has a distinct competitive advantage among the leading groups endeavouring to research and develop new psychedelic treatments. With this expertise and data, we will work to enhance our intellectual property, including and developing new chemical entities, while providing patients with access to new pathways to treat their mental health disorders.”
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.
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.
