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Mycrodose Therapeutics Receives DEA License to Research Four Psychedelics

Mycrodose Therapeutics Receives DEA License to Research Four Psychedelics

Mycrodose Therapeutics is pleased to announce that the company has been approved by the United States Drug Enforcement Agency (DEA), State of California Attorney General’s Research Advisory Board, and The US Food & Drug Administration (FDA) to research four (4) psychedelic compounds at their San Diego, California laboratory.

The company’s Schedule I DEA License was granted final approval after the DEA conducted an extensive in-person audit of Mycrodose Therapeutics’ facilities and after the FDA conducted an extensive review of the company’s in-depth research protocols for using Psilocybin, LSD, MDMA, and DMT in the development of their IP protected drug delivery technologies.

Mycrodose Therapeutics is one of a few private companies that has been granted a Schedule I License to research four (4) psychedelic compounds by the United States Drug Enforcement Agency (DEA).

“With the approval to research four Schedule I active pharmaceutics ingredients in our laboratory, we are extremely excited to marry those substances with our proprietary advanced drug delivery technologies. We are confident that our non-conventional drug delivery platforms will not only make the use of psychedelic drugs much safer but also increase the number of patients that can be treated with these powerful APIs. I’m thinking here in particular about children and the elderly. Due to the projected tight dosage control and the convenience of use, we are poised to elevate the status quo of psychedelic drug use in many medical conditions”, says Dr. Kochinke, Mycrodose Therapeutics, Chief Science Officer.

Dr. Frank Kochinke has over 30 years of experience inventing advanced drug delivery technologies and working with Schedule I compounds within the pharmaceutical-biotech industry. Having this in-house core expertise allowed Mycrodose Therapeutics to apply directly to the DEA, whereas many companies in the Psychedelic sector rely on the experience of third-party research institutions or Universities to carry out their research protocols.

Mycrodose Therapeutics laboratory in San Diego is currently in development of two (2) of their four (4) core technologies; the transdermal patch and transmucosal lozenge. The company’s IP Protected technology delivers a sustained and controlled dose of medicine into the body over time, which is believed to be safer and more effective than conventional drug delivery methods.

“We are excited to have a team with the expertise to obtain our Schedule I DEA license without needing to partner with a research institution or University. This milestone continues to validate the depth of our team, our research protocols, and our technologies,” says Chad Conner, Chief Executive Officer.

About Mycrodose Therapeutics:
Mycrodose Therapeutics (http://www.MycrodoseThera.com) is a US-Based pharmaceutical company headquartered in San Diego, California specializing in the development of advanced drug delivery systems utilizing psychedelic compounds to treat mental health and cognitive degenerative diseases. Mycrodose is one of only a few private companies that has been granted a Schedule I License to research four (4) psychedelic compounds: Psilocybin, MDMA, DMT & LSD by the United States Drug Enforcement Agency (DEA).

For more information about Mycrodose Therapeutics, please contact:

Patrick Eckstrom
Chief Operating Officer
Mycrodose Therapeutics
Email: mailto:Patrick@MycrodoseThera.com [Patrick@MycrodoseThera.com __title__ null]
Phone: 1-619-494-1367
Website: http://www.MycrodoseThera.com

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Cybin Awarded Notice of Allowance from U.S. Patent and Trademark Office for CYB004 (Deuterated Psychedelic Tryptamine) for the Treatment of Anxiety Disorders

Cybin Awarded Notice of Allowance from U.S. Patent and Trademark Office for CYB004 (Deuterated Psychedelic Tryptamine) for the Treatment of Anxiety Disorders

– Expands intellectual property portfolio and strengthens position as leading innovator in developing putative psychedelic compounds –

TORONTO–(BUSINESS WIRE)– Cybin Inc. ( NEO:CYBN) ( NYSE American:CYBN) (“ Cybin” or the “ Company”), a biopharmaceutical company focused on progressing “Psychedelics to Therapeutics TM” today announced that it has been awarded a Notice of Allowance from the U.S. Patent and Trademark Office (“USPTO”) for patent application No. 17/394,038 related to CYB004, the Company’s investigational deuterated psychedelic tryptamine compound for the potential treatment of anxiety disorders. The allowed claims include other forms of deuterated psychedelic tryptamine, notably certain deuterated forms of DMT and  5-MeO-DMT. The patent, which is expected to expire in 2041 before consideration of any patent term extensions, covers composition of matter for the CYB004 drug substance as a putative new chemical entity.

“The receipt of this Notice of Allowance from the USPTO represents an important milestone in expanding our intellectual property portfolio progressing psychedelics to therapeutics for the countless patients in need, and strongly demonstrates the Company’s dedication to the discovery and development of differentiated psychedelic-based compounds for addressing mental health,” said Doug Drysdale, Chief Executive Officer of Cybin. “Once issued, this patent may have the opportunity to cover a broad range of claims supporting our IP in psychedelic medicine and further strengthen our emerging best-in-class position in this evolving industry.”

According to the U.S. National Institute of Mental Health, anxiety disorders are one of the most common mental illnesses in the U.S., affecting 40 million adults, or approximately 18% of the population every year1. Despite the availability of many prescription medicines, these treatments are not equally efficacious in all patients with up to 50% of patients with general anxiety disorder failing to respond to first line treatments2. Current standardized treatments for anxiety disorders also require chronic administration of medicines that have a long time to onset and present several potential side effects including weight gain, gastrointestinal disturbances, sexual dysfunction and withdrawal symptoms.

“CYB004 is a proprietary deuterated psychedelic tryptamine that has the potential to effectively treat anxiety disorders without the well-known side effects of the current treatment landscape,” concluded Drysdale.

Cybin continues to pursue multiple opportunities to secure and support its patent position for research and development evaluating deuterated tryptamines for future psychedelic-based treatments for mental illnesses.

About Cybin
Cybin is a leading ethical biopharmaceutical company, working with a network of world-class partners and internationally recognized scientists, on a mission to create safe and effective therapeutics for patients to address a multitude of mental health issues. Headquartered in Canada and founded in 2019, Cybin is operational in Canada, the United States, United Kingdom and Ireland. The Company is focused on progressing Psychedelics to Therapeutics™ by engineering proprietary drug discovery platforms, innovative drug delivery systems, novel formulation approaches and treatment regimens for mental health disorders. Patent filings described herein are held by Cybin IRL Limited, a wholly owned subsidiary of Cybin.

Cautionary Notes and Forward-Looking Statements
Certain statements in this press release constitute forward-looking information. All statements other than statements of historical fact contained in this press release, including, without limitation, statements regarding Cybin’s future, strategy, plans, objectives, goals and targets, and any statements preceded by, followed by or that include the words “believe”, “expect”, “aim”, “intend”, “plan”, “continue”, “will”, “may”, “would”, “anticipate”, “estimate”, “forecast”, “predict”, “project”, “seek”, “should” or similar expressions or the negative thereof, are forward-looking statements. Forward-looking statements in this news release include statements regarding the Company’s proprietary drug discovery platforms, innovative drug delivery systems, novel formulation approaches and treatment regimens to potentially treat psychiatric disorders.

These forward-looking statements are based on reasonable assumptions and estimates of management of the Company at the time such statements were made. Actual future results may differ materially as forward-looking statements involve known and unknown risks, uncertainties, and other factors which may cause the actual results, performance, or achievements of the Company to materially differ from any future results, performance, or achievements expressed or implied by such forward-looking statements. Such factors, among other things, include: implications of the COVID-19 pandemic on the Company’s operations; fluctuations in general macroeconomic conditions; fluctuations in securities markets; expectations regarding the size of the psychedelics market; the ability of the Company to successfully achieve its business objectives; plans for growth; political, social and environmental uncertainties; employee relations; the presence of laws and regulations that may impose restrictions in the markets where the Company operates; and the risk factors set out in the Company’s management’s discussion and analysis for the period ended September 30, 2021 and the Company’s listing statement dated November 9, 2020, which are available under the Company’s profile on www.sedar.com and with the U.S. Securities and Exchange Commission on EDGAR at www.sec.gov. Although the forward-looking statements contained in this news release are based upon what management of the Company believes, or believed at the time, to be reasonable assumptions, the Company cannot assure shareholders that actual results will be consistent with such forward-looking statements, as there may be other factors that cause results not to be as anticipated, estimated or intended. Readers should not place undue reliance on the forward-looking statements and information contained in this news release. The Company assumes no obligation to update the forward-looking statements of beliefs, opinions, projections, or other factors, should they change, except as required by law.

Cybin makes no medical, treatment or health benefit claims about Cybin’s proposed products. The U.S. Food and Drug Administration, Health Canada or other similar regulatory authorities have not evaluated claims regarding psilocybin, psychedelic tryptamine, tryptamine derivatives or other psychedelic compounds. The efficacy of such products has not been confirmed by approved research. There is no assurance that the use of psilocybin, psychedelic tryptamine, tryptamine derivatives or other psychedelic compounds can diagnose, treat, cure or prevent any disease or condition. Rigorous scientific research and clinical trials are needed. Cybin has not conducted clinical trials for the use of its proposed products. Any references to quality, consistency, efficacy and safety of potential products do not imply that Cybin verified such in clinical trials or that Cybin will complete such trials. If Cybin cannot obtain the approvals or research necessary to commercialize its business, it may have a material adverse effect on Cybin’s performance and operations.

Neither the Neo Exchange Inc. nor the NYSE American LLC stock exchange have approved or disapproved the contents of this news release and are not responsible for the adequacy and accuracy of the contents herein.

1) Bandelow B, Michaelis S. Epidemiology of anxiety disorders in the 21st century. Dialogues Clin Neurosci. 2015;17(3):327-335. doi:10.31887/DCNS.2015.17.3/bbandelow
2) Ansara ED. Management of treatment-resistant generalized anxiety disorder. Ment Health Clin. 2020;10(6):326-334. Published 2020 Nov 5. doi:10.9740/mhc.2020.11.326

Investor & Media Contacts:
Leah Gibson
Vice President, Investor Relations
Cybin Inc.
leah@cybin.comSource: Cybin Inc.

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Algernon Pharmaceuticals Completes Manufacturing of Psychedelic Drug DMT Appoints UK Stroke Experts for Phase 2

Algernon Pharmaceuticals Completes Manufacturing of Psychedelic Drug DMT Appoints UK Stroke Experts for Phase 2

VANCOUVER, British Columbia, Dec. 08, 2021 (GLOBE NEWSWIRE) — Algernon Pharmaceuticals Inc. (the “Company” or “Algernon”) (CSE: AGN) (FRANKFURT: AGW) (OTCQB: AGNPD) a clinical stage pharmaceutical development company is pleased to announce that it has completed the manufacturing of its clinical grade supply (“cGMP”) of AP-188 (“N,N-Dimethyltryptamine or DMT”) at Canadian manufacturer Dalton Pharma Services. The Company believes it has produced a sufficient supply of cGMP DMT to complete its planned Phase 1 and Phase 2 clinical trials.

The Company also announces it has appointed Dr. Anthony Rudd and Dr. Robert Simister, both from the U.K., as medical consultants to the Company’s DMT stroke clinical research program. Both Dr. Rudd and Dr. Simister have extensive backgrounds in stroke management as well as clinical care and stroke research. Their primary responsibility will be to help guide the Company’s Phase 2 acute stroke and post stroke therapy clinical trials planned to begin in the U.K. in the latter part of 2022, after the Phase 1 trial has been completed.

Dr. Anthony Rudd

Anthony Rudd, MB, BChir, FRCP, CBE is an emeritus professor of Stroke Medicine at Kings College London and recently retired as a consultant stroke physician at Guy’s and St Thomas’ Hospital. He was the London Stroke Clinical Director from 2010-2019 and the National Clinical Director for Stroke for NHS England from 2013-2019, where he oversaw dramatic improvements in the paradigm of NHS stroke treatment.

For over 20 years he chaired the Intercollegiate Stroke Working Party at the Royal College of Physicians which was responsible for developing the National Clinical Guidelines for Stroke and running the National Sentinel Stroke Audit program. He chaired the National Institute for Health and Care Excellence (NICE) Guidelines Group for Acute stroke and TIA and the NICE Stroke Quality Standards Development Group. He is also past president of the British Association of Stroke Physicians and is Honorary Vice President of the Stroke Association.

Dr. Rudd was educated at Cambridge and King’s College London, receiving his medical degree in 1978. His research interests are stroke rehabilitation, organization of care and quality improvement. He has published over 300 peer reviewed publications and supervised fourteen higher degrees.

He was made a CBE (Commander of the British Empire) in 2013 in recognition of his services to stroke medicine.

Dr. Robert Simister

Robert Simister MA MB BS PhD FRCP is a consultant neurologist and stroke physician as well as an honorary senior lecturer at University College London, where he also serves as the Clinical Lead for the Comprehensive Stroke Service and the Clinical Director of Stroke Medicine and Acute Neurology. Since 2019, he has been the Joint Clinical Director for the London Stroke Clinical Network.

Dr. Simister received his medical degree from the Charing Cross and Westminster Medical School, now part of Imperial College London, and was awarded his PhD in Neuroscience from University College London in 2012. In addition to his consulting and directorial responsibilities, he maintains an active research program directed towards improving outcomes for stroke patients.

“Completing production of a cGMP supply of DMT is a major milestone for the Company’s clinical stroke research program and it ensures that we will have a supply of the drug for our planned Phase 1 and 2 clinical trials,” said Christopher J. Moreau CEO of Algernon Pharmaceuticals Inc. “We are also very pleased to have Dr. Rudd and Dr. Simister join as medical consultants as we now begin the process of planning our Phase 2 studies for both acute stroke and for therapy post stroke.”

About Algernon Pharmaceuticals Inc. 

Algernon is a drug re-purposing company that investigates safe, already approved drugs, including naturally occurring compounds, for new disease applications, moving them efficiently and safely into new human trials, developing new formulations and seeking new regulatory approvals in global markets. Algernon specifically investigates compounds that have never been approved in the U.S. or Europe to avoid off label prescription writing.

CONTACT INFORMATION

Christopher J. Moreau
CEO
Algernon Pharmaceuticals Inc.
604.398.4175 ext 701
info@algernonpharmaceuticals.com
investors@algernonpharmaceuticals.com
www.algernonpharmaceuticals.com

Neither the Canadian Securities Exchange nor its Market Regulator (as that term is defined in the policies of the Canadian Securities Exchange) accepts responsibility for the adequacy or accuracy of this release.

CAUTIONARY DISCLAIMER STATEMENT: No Securities Exchange has reviewed nor accepts responsibility for the adequacy or accuracy of the content of this news release. This news release contains forward-looking statements relating to product development, licensing, commercialization and regulatory compliance issues and other statements that 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 are forward-looking statements that involve risks and uncertainties. There can be no assurance that such statements will prove to be accurate and actual results and future events could differ materially from those anticipated in such statements. Important factors that could cause actual results to differ materially from the Company’s expectations include the failure to satisfy the conditions of the relevant securities exchange(s) and other risks detailed from time to time in the filings made by the Company with securities regulations. The reader is cautioned that assumptions used in the preparation of any forward-looking information may prove to be incorrect. Events or circumstances may cause actual results to differ materially from those predicted, as a result of numerous known and unknown risks, uncertainties, and other factors, many of which are beyond the control of the Company. The reader is cautioned not to place undue reliance on any forward-looking information. 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. Forward-looking statements contained in this news release are expressly qualified by this cautionary statement. The forward-looking statements contained in this news release are made as of the date of this news release and the Company will update or revise publicly any of the included forward-looking statements as expressly required by applicable law.

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Ayahuasca vs placebo

Ayahuasca users report psychological benefits after taking placebo at a ritualistic ceremony

An ayahuasca retreat could make you more empathetic!

In a recent study, participants reported reduced stress, anxiety, and depression after attending an ayahuasca ceremony… even those who were given a placebo.

However, only the ayahuasca users showed increased empathy.

The supportive group atmosphere could explain why people experienced benefits even without taking ayahuasca.

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Way2Grow (W2G) Biopharma Corp. Receives Health Canada Approval Notice for Construction of a Controlled Substances Dealer’s Licence Level 8 Psychedelic Secure Environ and Psilocybin Production Campus

Way2Grow (W2G) Biopharma Corp. Receives Health Canada Approval Notice for Construction of a Controlled Substances Dealer’s Licence Level 8 Psychedelic Secure Environ and Psilocybin Production Campus

OSOYOOS, British Columbia, Nov. 17, 2021 (GLOBE NEWSWIRE) — via InvestorWire — Way2Grow Biopharma Corp. (“W2G” or the “Company”), a privately held therapeutic corporation existing under the laws of British Columbia, is pleased to announce approval of a Health Canada Dealer’s Licence Application, in which Health Canada issued notice to W2G to complete the construction of a Level 8 Secure Environ and Psilocybin Production Campus. A Health Canada Dealer Licence and production facility will allow W2G to procure psychedelics as well as propagate, cultivate, harvest and sell psychedelics to pharmacies, clinics and other licenced research facilities for allowable research purposes pursuant to the Controlled Drugs and Substances Act (the “CDSA”).

Licensing

W2G is pioneering a comprehensive Life Science Therapeutic Production Campus with the goal of researching, advancing and manufacturing life science therapeutics. W2G’s Therapeutic Production Campus supports small room, closed-loop, evidence-based therapeutic research and production. The Company’s pure cultivation approach is rooted in science, is empirically based, organically grown and evidence driven. W2G’s approach uses standardized tissue culture and micropropagation to cultivate and extract pure organic cannabis and psychedelic therapeutics. Completion of the Level 8 Controlled Substances Dealer’s Licence will allow W2G to cultivate, extract and store up to $30 million in value of psychedelics compounds, including psilocybin/psilocin (magic mushrooms), N, N-Dimethyltryptamine (DMT), Ololiuqui (Morning Glory), mescaline and peyote.

W2G will be the first comprehensive Life Science Therapeutic Production Campus specializing in psychedelic and cannabis production, micropropagation, organic cultivation, processing and therapeutic manufacturing in North America.  Approval of the Controlled Substances Dealer’s Licence allows W2G to procure controlled substances by synthesis, propagation, cultivation and harvesting of psychedelic substances. W2G will be permitted to sell psychedelic compounds to other licenced dealers, authorized hospitals, research facilities and academic institutions until such time that psychedelics are prescribed by authorized physicians.

To fulfill W2G’s innovative research plans in psychedelic formulations, the Company’s plans include EU-GMP-compliant facility construction to allow for the import and export of psychedelics therapeutics to expand evidence-based psychedelics research through global partnerships. W2G’s research plans include improving breeding programs, standardizing psilocybin production, and the examination of psychedelics’ combinative efficacy on treating certain health conditions.

W2G’s cultivation relies on a small, closed room approach to growing consistent organic medical psilocybin. Each W2G cultivar or spore starts with a consistent germplasm developed though natural breeding and tissue culture. The future of W2G germplasm development will integrate the use of advanced genomic and genetic engineering to produce novel biotechnologies. Each cultivation room operates under specific growing conditions to maintain optimal production and consistent quality of medicinal compounds.

W2G has pioneered a new and strategic comprehensive Life Science Therapeutic Production Campus by combining its expertise in organic cultivation technology with an experienced genetic advancement team, innovative pharmaceutical research plans and intellectual property development, coupled with the highest level of security.

“We are excited to enter this next phase of life science therapeutics, and we believe this unique combination will lead to the highest-quality targeted organic therapeutic products. As we enter this next phase of our company’s evolution, we will focus on building strategic partnerships to help disseminate our psychedelics research and to expand our distribution,” stated W2G CEO Jamie Filipuzzi.

About W2G

W2G is a privately held therapeutic company in the life science industry. W2G began with a vision to help patients gain better access to high-quality, consistent, organic therapeutics. To achieve this vision, W2G has developed a consistent growth plan using tissue culture and molecular biology. These methods allow for the standardization of the procedures used to ensure quality and consistency of W2G’s therapeutics.

W2G’s extensive research and intellectual property approach are focused on the development of several new plant-based cultivation techniques, hybrid cultivar development, genetic profiling and tissue culture. By developing a molecular breeding and genetics program, we can identify new bioactive compounds to determine interaction with specific genes responsible for chronic diseases.

W2G is located in Osoyoos, British Columbia, and is federally regulated in Canada under the Cannabis Act (S.C. 2018, c. 16) and the Cannabis Regulations (SOR/2018-144)).

FORWARD-LOOKING STATEMENTS

This news release may contain “forward-looking statements.” These statements relate to future events or future performance of Way2Grow. Statements which are not purely historical are forward-looking statements and include any statements regarding beliefs, plans, outlook, expectations or intentions regarding the future, including words or phrases such as “anticipate,” “may,” “will,” “might,” “should,” “could,” “can,” “intend,” “expect,” “believe,” “plan,” “project,” “continue” or similar expressions that suggest future outcomes or the negative thereof or similar variations. Such forward-looking statements include, but are not limited to, statements concerning W2G’s research, development and expansion plans, including its Health Canada application for the Dealer Licence and Section 56 Exemption, and the potential results from such Licensing.

Forward-looking statements are based on management’s current expectations and may materially differ from actual results. Further, such forward-looking statements are subject to risks and uncertainties that could negatively affect our business, operating results and financial condition, including, without limitation, risks arising from a delay in Licensing and financing risks. We expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in our expectations or any change in events, conditions or circumstances on which any such statement is based, except as required by law.

Contact Information:

JJ Filipuzzi, Investor Relations
Phone: (403) 554-5973
Email: info@w2g.ca
Website:  www.w2g.ca

Wire Service Contact
InvestorWire (IW)
Los Angeles, California
www.InvestorWire.com
212.418.1217 Office
Editor@InvestorWire.com

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Discussions With FDA Provide Guidance For Phase IIb Clinical Trial Design For DMT-assisted Therapy For Major Depressive Disorder

Discussions With FDA Provide Guidance For Phase IIb Clinical Trial Design For DMT-assisted Therapy For Major Depressive Disorder

FDA discussions pave pathway for U.S. clinical trial preparations

LONDON, Nov. 15, 2021  — Small Pharma Inc. (TSXV: DMT) (OTCQB: DMTTF) (the “Company” or “Small Pharma”), a neuropharmaceutical company focused on psychedelic-assisted therapies, today confirms, following positive discussions with the U.S. Food and Drug Administration (the “FDA”), that preparations are now underway for the U.S. component of its Phase IIb clinical trial for its lead candidate, SPL026, a N,N-dimethyltryptamine (“DMT”) assisted therapy for the treatment of major depressive disorder (“MDD”).

Dr Carol Routledge, Chief Medical and Scientific Officer of Small Pharma, said:

Discussions with the FDA are always a critical element in any clinical program planning, and we are delighted with the outcome.  The discussions were quite wide ranging, from manufacturing and non-clinical elements to providing guidance on the Phase IIb clinical trial design to be conducted in patients with MDD.  Importantly, the FDA’s feedback facilitates a path forward to prepare for the inclusion of U.S. sites in our Phase IIb clinical trial, which we anticipate will also be conducted across sites in Europe and the U.K.  We believe that Small Pharma is conducting the first clinical trials of a DMT-assisted therapy for patients with MDD, with the potential to provide a much-needed alternative treatment for patients suffering from this debilitating condition.”

About Small Pharma

Small Pharma is a neuropharmaceutical company specialized in IP-led development of novel treatments for mental health conditions, with a focus on depression. Small Pharma initiated a clinical program into N,N-dimethyltryptamine (“DMT”) assisted therapy in February 2021. This program includes a Phase I/IIa trial on the Company’s lead candidate alongside development of a robust pipeline of proprietary preclinical assets.

About DMT 

DMT is a naturally occurring psychedelic tryptamine found in plants and in the brain of mammals. Scientific evidence suggests DMT offers the potential for rapid-acting and long-lasting antidepressant effects. DMT is differentiated by its short psychedelic experience (< 30mins), which allows for short treatment sessions and offers the potential for convenient supervised treatments within patient clinics. Small Pharma is advancing a pipeline of DMT-based therapies and is leading the world’s first DMT clinical trial for depression, in collaboration with Imperial College London.

For further information contact: 

Small Pharma

Peter Rands
Chief Executive Officer
Email: ir@smallpharma.co.uk

Media Relations Contacts:

McKenna Miller
KCSA Strategic Communications
Email: smallpharmapr@kcsa.com
Tel: +1 (949) 949-6585

Investor Relations Contacts:
Eric Ribner
LifeSci Advisors
Email: eric@lifesciadvisors.com

Tim Regan/Adam Holdsworth
KCSA Strategic Communications
Email: tregan@kcsa.com
Tel: +1 (347) 487-6788

Cautionary Note Regarding Forward-Looking Statements

This press release contains statements that constitute “forward-looking information” (“forward-looking information”) within the meaning of the 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 news release include statements regarding the potential for 6-HNK to deliver rapid antidepressant effects and an improved side effect profile to ketamine as an antidepressant, the Company’s ability to securely investigate the commercial potential of SPL801B, the Company’s ability to innovate and develop novel treatment candidates for mental health conditions through ketamine-based candidates, and the Company’s ability to develop solutions to effectively address depression through DMT-based therapies. In disclosing the forward-looking information contained in this press release, the Company has made certain assumptions. 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 the Company’s business and results of operations; 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.

Small Pharma makes no medical, treatment or health benefit claims about its proposed products. The Medicines and Healthcare products Regulatory Agency (“MHRA”) or other similar regulatory authorities have not evaluated claims regarding DMT-assisted therapies and other next generation psychoactive compounds. The efficacy of such therapies has not been confirmed by MHRA-approved research. There is no assurance that such DMT-assisted therapies and other psychoactive compounds can diagnose, treat, cure or prevent any disease or condition. Vigorous scientific research and clinical trials are needed. Any references to quality, consistency, efficacy and safety of potential therapies do not imply that Small Pharma verified such in clinical trials or that Small Pharma will complete such trials. If Small Pharma cannot obtain the approvals or research necessary to commercialize its business, it may have a material adverse effect on Small Pharma’s performance and operations.

The TSX Venture Exchange (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.

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Psilocybin production increases 11,900%

DEA Boosts Psilocybin, MDMA And DMT Production Levels Again In Final Quotas For 2021

To keep up with the growing demand for psychedelic research, the DEA is yet again increasing the legal production quotas for certain Schedule I substances!

The original proposal for psilocybin was just 50 grams, which increased to 1,500 grams in September. The final quota is now 6,000 grams – a total increase of 11,900%!

Production of both MDMA and DMT increased 6,300% from 50 grams to 3,200 grams.

 

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Healing veterans with DMT

DMT and PTSD

In honour of Veteran’s Day, we’re sharing the story of how a Special Ops veteran changed his life with DMT.

Asher Gibson was diagnosed with PTSD and traumatic brain injury after countless combats across the world. Prescription medications began to dominate his life, so he turned to psychedelic healing.

After smoking DMT, the powerful compound found in ayahuasca, Asher was blasted out of his body and traveled through different dimensions to the beginning of time.

“I remember my whole head being ecstatic and numb, like the most wonderful electrical massage on my brain. The feeling moved down my neck and shoulders and eventually filled my entire body.”

After the trip, Asher’s debilitating neck and shoulder pain was almost non-existent and his mental state subsided to manageable levels. He is no longer dependent on prescription drugs.

“While DMT isn’t the magic button that fixes everything, I believe it’s a powerful guide to help you do the work yourself,” he explains.

To bring this kind of relief to other veterans, consider supporting the Heroic Hearts Project – a non-profit organization that provides ayahuasca retreats for veterans with combat experience or military sexual trauma.

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