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MDMA works better than antidepressants

Latest Trials Confirm the Benefits of MDMA – the Drug in Ecstasy – for Treating PTSD

Plus, the effects are long-lasting!

A recent analysis found that, on average, patients who received MDMA-assisted therapy experienced a 22 point reduction in PTSD scores, whereas daily antidepressants only reduced scores by 6 to 14 points. 

One year after receiving the treatments, patients still reported benefits:

  • 84% reported improved feelings of well-being
  • 71% had fewer nightmares
  • 69% had less anxiety
  • 66% had improved sleep

Why is it so effective? MDMA reduces feelings of intense anxiety, allowing patients to open up and work through traumatic memories without fear.

PDF of article

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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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Levitee Labs Announces Strategic Partnership with LiveRx Research Group to Provide Equitable Access to Hepatitis C Care throughout Alberta, Canada

Levitee Labs Announces Strategic Partnership with LiveRx Research Group to Provide Equitable Access to Hepatitis C Care throughout Alberta, Canada

Levitee Labs Announces Strategic Partnership with LiveRx Research Group to Provide Equitable Access to Hepatitis C Care throughout Alberta, Canada

  • Treatment for Hepatitis C Virus (HCV) is effective in over 95% of infected patients, yet remains disproportionately unavailable to certain patient groups across Canada.
  • Levitee Clinics and Levitee Pharmacies will work collaboratively with LiveRx to create easily accessible patient-centric HCV care, impacting currently under-served patient groups, including those with mental health conditions such as substance use disorders.
  • The partnership involves Levitee Labs promoting and implementing the LiveRx test and treat program, providing HCV screening and treatment, in addition to communications on optimal care strategies through the Levitee Labs’ portfolio of companies.

VANCOUVER, BC, CANADA, December 20th, 2021 /CNW/ – Levitee Labs Inc. (CSE: LVT) (OTC: LVTTF) (FSE: 7H7) (the “Company” or “Levitee”), an integrative wellness company with a diversified portfolio of healthcare and wellness assets, today announces a new strategic collaboration with the LiveRx Research Group (“LiveRx”) for testing, treating, and curing HCV in Alberta.

LiveRx is a project led by Dr. Mark G. Swain, Head of the Division of Gastroenterology and Hepatology at the University of Calgary and funded by The Alberta Innovates Partnership for Research and Innovation in the Health System (PRIHS) funding program. LiveRx is dedicated to addressing inequities in the current specialist referral-based HCV care model.

Levitee Labs and LiveRx will work jointly to create an equitable, patient-centric HCV care model that facilitates shifting HCV care from specialist treatment centers in urban centers to easily accessible clinics and pharmacies across the province.

As part of the collaboration agreement, Levitee Labs will implement the LiveRx HCV test and treat program at its Levitee Clinics and Levitee Pharmacies across Alberta from January 2022 through January 2024.

The following activities will be part of the collaboration with LiveRx:

  • Conducting HCV screening and testing for Levitee Clinics patients.
  • Including patients identified with HCV who are within the Levitee Clinics care program as part of the LiveRx HCV eradication research program.
  • Undertaking HCV treatment for appropriate HCV-infected individuals through a Levitee-linked pharmacy with full support of LiveRx where available.
  • Promoting the LiveRx program at Levitee Clinics and Levitee Pharmacies sites.
  • Communicating regularly with the LiveRx Research Group to assess implementation successes, challenges, and further needs, and make mutually agreed upon changes where appropriate.

In Canada, it is estimated that 250,000 Canadians are living with chronic HCV and thousands of new cases are diagnosed each year1. 44% of those infected are unaware of their HCV status2; symptoms can take two weeks to six months to appear, and most people will not develop symptoms3. If left untreated, HCV can progress over time to serious liver damage and is associated with a range of systemic health problems, decreased quality of life, and increased healthcare costs4. The North American HCV drug market was valued at USD$3.7 billion as of 2018.5

“HCV infects up to 1% of Canadians and can lead to dire complications, such as liver cancer and irreversible liver scarring, for which there are limited treatment options,” commented Dr. Mark G. Swain. “What’s disheartening is that current HCV treatments can safely cure more than 95% of these infected individuals, but access to these therapies are disproportionately unavailable to priority populations, an obstacle that we are optimistic we can overcome by modifying the standard of care through work with companies like Levitee Labs.”

“As I am an expert in HCV care, we are thrilled to be working with Dr. Swain and his team with the common goal of eradicating HCV in Alberta,” commented Noha ElSayed, B.Sc.Pharm, APA, Executive Director, Levitee Clinics and Levitee Pharmacies, Alberta Region. “By combining resources and implementing a non-judgmental practice to testing and community-based approach to treatment, we can make a meaningful impact on healthcare from both personal and provincial perspectives.”

Sources:

1. The Canadian Network on Hepatitis C Blueprint Writing Committee and Working Groups. Blueprint to inform hepatitis C elimination efforts in Canada. Montreal, QC: Available at: https://www.canhepc.ca/sites/default/files/media/documents/blueprint_hcv_2019_05.pdf. Accessed on: July 21, 2021.
2. Public Health Agency of Canada. Report on Hepatitis B and C in Canada: 2017.  Centre for Communicable Disease and Infection Control, Infectious Disease Prevention and Control Branch, Public Health Agency of Canada; 2019. Available at: https://www.canada.ca/en/services/health/publications/diseases-conditions/report-hepatitis-b-c-canada-2017.html. Accessed on: July 21, 2021.
3. CATIE. The epidemiology of hepatitis C in Canada. Available at: https://www.catie.ca/the-epidemiology-of-hepatitis-c-in-canada-0. Accessed on: July 21, 2021
4. The Canadian Network on Hepatitis C Blueprint Writing Committee and Working Groups. Blueprint to inform hepatitis C elimination efforts in Canada. Montreal, QC: Available at: https://www.canhepc.ca/sites/default/files/media/documents/blueprint_hcv_2019_05.pdf. Accessed on: July 21, 2021.5. https://www.fortunebusinessinsights.com/industry-reports/hepatitis-c-drug-market-101562

About the LiveRx Research Group

LiveRx Research Group is a medical research project led by Dr. Mark G. Swain, Head of the Division of Gastroenterology and Hepatology at the University of Calgary and funded by The Alberta Innovates Partnership for Research and Innovation in the Health System funding program (PRIHS) from 2021-2024. The project is focused on tackling the challenge of inequitable access to Hepatitis C Virus care in Alberta.

LiveRx believes the current model of specialist care leaves many Albertans unable to access proper testing or treatment. LiveRx follows a 5-part strategy to bring hepatitis C virus screening, treatment and cures to Albertans. LiveRx utilizes a novel approach, based on partnerships between pharmacists and community-based organizations, to deliver hepatitis C virus support to Albertans. For further information about LiveRx please visit: www.epicore.ualberta.ca/liverx

About Levitee Labs 

Levitee is establishing itself as a leader in the integrative wellness space. Through leveraging an M&A regimen that focuses on the centralization of complementary integrative wellness assets, Levitee aims to transform mental health and addiction treatments through the integration of psychedelic medicines and therapies.

The Company’s current portfolio of assets includes: Levitee Clinics™, a group of five operating addiction and pain treatment clinics in Alberta; Levitee Pharmacies™, three pharmacies operating in Alberta specialized in filling prescriptions for patients with substance use disorders, mental health conditions, and chronic pain; BlockMD, the first technology company in Alberta to receive provincial approval for electronic-prescriptions in the addiction treatment space; and Earth Circle Organics, a direct-to-consumer and wholesaler of supplements and superfood products with 180+ SKUs in its product lineup across three brands. Further information about Levitee is available on its website at www.leviteelabs.com.

Investor and Corporate Communications: 

Pouya Farmand, CEO & Co-Founder

+1 833-381-8660

ir@leviteelabs.com

Media Contact: 

Olivia Belcher-Coward, Marketing & Communications Manager

media@leviteelabs.com

Forward-Looking Statements

This news release contains certain statements that may constitute forward-looking information under applicable securities laws. All statements, other than those of historical fact, which address activities, events, outcomes, results, developments, performance, or achievements that Levitee anticipates or expects may or will occur in the future (in whole or in part) should be considered forward-looking information. Such information may involve, but is not limited to, statements respecting Levitee’s business plans and proposed products, and the benefits derived from mushroom-infused products; the acquisitive growth potential of Levitee once acquisitions are completed; the expectation that Levitee will continue to execute its accretive acquisition program, and the contribution of such program to Levitee’s future growth potential; and Levitee’s objective to transform mental health and addiction treatments through the integration of psychedelic medicines and therapies. Often, but not always, forward-looking information can be identified by the use of words such as “plans”, “expects”, “is expected”, “budget”, “scheduled”, “estimates”, “forecasts”, “intends”, “anticipates”, or “believes” or variations (including negative variations) of such words and phrases, or statements formed in the future tense or indicating that certain actions, events or results “may”, “could”, “would”, “might” or “will” (or other variations of the forgoing) be taken, occur, be achieved, or come to pass. These statements and other forward-looking information are based on assumptions made by Levitee based on currently available competitive, financial and economic data and operating plans, strategies or beliefs as of the date of this news release as well as management’s current expectations or beliefs regarding future growth, results of operations, future capital (including the amount, nature and sources of funding thereof) and expenditures. These assumptions may also be based on information obtained from third-party industry analysts and other third-party sources. Forward-looking information is necessarily based on a number of opinions, assumptions and estimates that, while considered reasonable by Levitee as of the date such statements are made, are subject to known and unknown risks, uncertainties, assumptions and other factors that may cause the actual results, performance or achievements to be materially different from those expressed or implied by such forward-looking information, including but not limited to risks associated with the following: Levitee’s limited history of operations; ability to secure additional financing; negative cash flow from operating activities since inception; regulatory requirements; changes in consumer preferences; supply of raw materials; reliance on a limited number of products; brand awareness; the ability to develop, market and produce new products; dependence on certain key senior managers; reliance on third parties for manufacturing and packaging; potential product liability claims and product recalls; and significant competition. For additional information regarding these risks, please see the risk factors identified and reported in Levitee’s public filings under its SEDAR profile at www.sedar.com. Any and all forward-looking information contained in this press release is expressly qualified by this cautionary statement. Readers are cautioned not to place undue reliance on forward-looking statements or information. The forward-looking information is made as of the date of this news release, and Levitee assumes no obligation to publicly update or revise such forward-looking information, except as required by applicable securities laws. The CSE (operated by CNSX Markets Inc.) has neither approved nor disapproved of the contents of this press release and accepts no responsibility for the adequacy or accuracy hereof.

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PharmaTher Enters Into Process Development Agreement With LTS Lohmann for Ketamine Microneedle Patch

PharmaTher Enters Into Process Development Agreement With LTS Lohmann for Ketamine Microneedle Patch

​TORONTO/ANDERNACH, December 20, 2021 — PharmaTher Holdings Ltd. (“PharmaTher”) (OTCQB: PHRRF) (CSE: PHRM), a company focused on the development and commercialization of specialty ketamine products, and LTS LOHMANN Therapie-Systeme AG (“LTS”), a leading pharmaceutical technology company, today announced they have entered into a process development agreement for the clinical trial scale up of PharmaTher’s proprietary Ketamine microneedle patch product.
In cooperation with the Queen’s University of Belfast, PharmaTher successfully completed the evaluation of a patented hydrogel-forming microneedle patch to deliver Ketamine, a potential next-generation treatment for neuropsychiatric, neurodegenerative and pain disorders.  Under the agreement, PharmaTher will cooperate with LTS in the process development and scale up of PharmaTher’s Ketamine microneedle patch product. LTS will be responsible for development and non-commercial manufacturing activities and support PharmaTher’s Investigational New Drug (IND) submission to the FDA in the U.S. and the Investigational Medicinal Product Dossier (IMPD) submission to EMA in the EU.  PharmaTher will be responsible for the planning and execution of clinical studies with the Ketamine microneedle patch product.

“We are excited to work with LTS, a leader in transdermal delivery systems, to complete the clinical development of our ketamine microneedle patch product for clinical studies and scale up for future commercial use,” said Fabio Chianelli, CEO of PharmaTher. “With our success in our proof of concept studies in delivering ketamine in our proprietary microneedle patch invivo, we now have a clear development path to unlock the value for ketamine in various unmet medical needs and we are focused on working closely with LTS to produce cGMP ketamine microneedle patches for PharmaTher’s upcoming Phase 1/ 2 clinical studies in 2022.”

Dr. Hanshermann Franke, SVP R&D and Member of the Global Leadership Team commented “LTS is a leading company in microneedle technology and we utilize our expertise, experience and innovation to create drug delivery solutions to improve patient outcomes. The effective treatment of mental illness and neurological disorders are core focus areas for us, and we are pleased to announce this partnership with PharmaTher in the expectation that we can lead the way in this unmet patient need.”

About PharmaTher’s Microneedle Patch

Microneedle-enhanced intradermal delivery is an elegant, efficient and painless method for increasing the skin permeation of many drugs, including ketamine. Transdermal delivery systems offer a number of advantages over inhalation and IV administration. PharmaTher‘s approach consists of a 2-part system comprised of a drug-loaded reservoir that is placed on top of the hydrogel microneedle array. After administration into the skin (i.e. intradermal delivery), the microneedles become hydrated and swell, creating pores for the reservoir to release the drug content into the tissue over the treatment course. Upon removal, the needles are intact, yet rounded, and do not need to be disposed of as sharps. The drug directly enters the systemic circulation, circumventing absorption and first-pass barriers typical for oral delivery.  Studies have shown that systemic drug concentrations are reached within minutes after administration and are maintained over multiple days with transdermal delivery. This system addresses a major unmet need by offering greater ease of administration, inclusion of patients with pre-existing conditions that exempt them from oral or inhalation dosing. In addition, it avoids syringe needles, eliminating pain and patient visits to a clinician.

About PharmaTher Holdings Ltd.

PharmaTher Holdings Ltd. (OTCQB: PHRRF) (CSE: PHRM) is a clinical-stage psychedelics biotech company focused on the research, development and commercialization of novel uses, formulations and delivery methods of psychedelics, such as ketamine, to treat mental health, neurological and pain disorders. PharmaTher is currently advancing an FDA approved phase 2 clinical study with ketamine to treat Parkinson’s disease and is developing a novel microneedle patch for the intradermal delivery of psychedelics and infectious disease treatments.  Learn more at:  PharmaTher.com and follow us on Twitter and LinkedIn.

About LTS LOHMANN Therapie-Systeme AG

LTS LOHMANN Therapie-Systeme AG is a leading pharmaceutical technology company that develops and manufactures innovative drug delivery systems such as Transdermal Patches (“TTS”) and Oral Thin Films (“OTF”) for the pharmaceutical industry. LTS´ commercial offering encompasses more than 20 marketed products and a diverse pipeline of more than 30 development projects targeting multiple disease indications. LTS’s innovation pipeline contains both partner-funded as well as proprietary, LTS-funded projects. LTS maintains its leading position through the continuous refinement of its core TTS and OTF technologies and by advancing emerging drug delivery technologies, including Micro Array Patches (MAP) for the transdermal delivery of large molecule, biological actives. Founded in 1984, LTS operates today from two sites in Andernach, Germany and West Caldwell, NJ, USA and a representative office in Shanghai, China.

For more information about PharmaTher, please contact:

Fabio Chianelli
Chief Executive Officer
PharmaTher Holdings Ltd.
Tel: 1-888-846-3171
Email: info@pharmather.com
Website: www.pharmather.com

For more information about LTS, please contact:

Dr. Iris Schnitzler
Head of Marketing and Market Services
LTS LOHMANN Therapie-Systeme AG
Email: iris.schnitzler@ltslohmann.com
Website: www.ltslohmann.com

Neither the Canadian Securities Exchange nor its Regulation Services Provider have reviewed or accept responsibility for the adequacy or accuracy of this release.

Cautionary Statement

This press release contains ‘forward-looking information’ within the meaning of applicable Canadian securities legislation. These statements relate to future events or future performance. The use of any of the words “could”, “intend”, “expect”, “believe”, “will”, “projected”, “estimated”, “potential”, “aim”, “may” and similar expressions and statements relating to matters that are not historical facts are intended to identify forward-looking information and are based on PharmaTher Holdings Ltd. (the “Company”) current belief or assumptions as to the outcome and timing of such future events. Forward-looking information is based on reasonable assumptions that have been made by the Company at the date of the information and is subject to known and unknown risks, uncertainties, and other factors that may cause actual results or events to differ materially from those anticipated in the forward-looking information. Given these risks, uncertainties and assumptions, you should not unduly rely on these forward-looking statements. The forward-looking information contained in this press release is made as of the date hereof, and Company is not obligated to update or revise any forward-looking information, whether as a result of new information, future events or otherwise, except as required by applicable securities laws. The foregoing statements expressly qualify any forward-looking information contained herein. Factors that could cause actual results to differ materially from those anticipated in these forward-looking statements are described under the caption “Risk Factors” in Company’s management’s discussion and analysis for the period of August 31, 2021 (“MD&A”), dated October 27, 2021, which is available on the Company’s profile at www.sedar.com.
​
This news release does not constitute an offer to sell or the solicitation of an offer to buy, and shall not constitute an offer, solicitation or sale in any state, province, territory or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state, province, territory or jurisdiction.

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Psyched Wellness Announces Path to Market for AME-1-derived Products in the USA

Psyched Wellness Announces Path to Market for AME-1-derived Products in the USA

Toronto, Ontario – December 16, 2021 – Psyched Wellness Ltd. (CSE: PSYC) (OTCQB: PSYCF) (FSE: 5U9) (the “Company” or “Psyched“), a life sciences company focused on the production and distribution of artisanal functional and psychedelic mushrooms, is pleased to announce that it is moving forward with its regulatory strategy to launch its Amanita Muscaria extract (“AME-1“)-derived consumer products in-stores in the United States market in the second quarter of 2022.

To achieve this, the Company is having a self-Generally Recognized As Safe (“GRAS“) dossier reviewed by an external GRAS panel of experts for the AME-1. The self-GRAS review process, which was recently upheld in federal court in the Southern District of New York, permits substances that are self-determined to be GRAS to be exempt from pre-market review by the FDA.

The self-GRAS process will permit AME-1 to be sold in specific foods outlined in the dossier and provide an exemption from pre-market notification as a New Dietary Ingredient (“NDI“) in dietary supplement products. Despite this allowable exemption from NDI notification, Psyched will proceed with plans to notify the FDA with an NDI notification and submit to Health Canada for a Natural Health Product Number (“NHPN“).

As AME-1 is a food supplement, Psyched is able to run parallel paths and sell in multiple food categories and jurisdictions: (i) completing a self-determined GRAS for inclusion of the ingredient in US conventional foods, (ii) submitting an NDI notification to the FDA for use and marketing in US dietary supplements, and (iii) applying to Health Canada for marketing as a natural health product.

“The ruling in late September on the FDA’s GRAS Self-Determination process is significant as it was upheld in the federal court in the Southern District of New York. The self-GRAS and NDI pathways will allow the Company to market AME-1 in conventional foods (Nutrition Facts) outlined in their GRAS, as well as dietary supplements (Supplement Facts), a category of food. These plans, as well as their application for an NHPN, will provide for greater penetration into additional food categories,” said KGK Science Chief Executive Officer, Najla Guthrie.

“While Psyched Wellness would have exemptions from having to file a NDI notification after completing a self-determined GRAS, the Company is going above and beyond their regulatory requirement by also planning to submit an NDI notification to the FDA. These are the actions of a company setting the bar high for food ingredient safety standards,” said KGK Science Chief Regulatory Officer, Corey Hilmas, MD/PhD.

“This is an important and logical step forward as we pursue our strategy to create premium Amanita Muscaria mushroom-derived products and become a leading North American brand in the emerging functional food category,” said Jeff Stevens, Chief Executive Officer of Psyched. “Working closely with KGK Science, we determined that applying for a self-GRAS, in addition to our NDI and NHPN action plans, de-risks and expedites our path to market in the United States.”

For further information, please contact:

Jeffrey Stevens
Chief Executive Officer
Psyched Wellness Ltd.
t: (647) 400-8494
e: jstevens@psyched-wellness.com

Website: http://www.psyched-wellness.com

Investor Contacts:
Tim Regan/Sophia Bashford
KCSA Strategic Communications
t: (347) 487-6788
e: PsychedWellness@kcsa.com

Neither the Canadian Securities Exchange nor its Regulation Services Provider have reviewed or accept responsibility for the adequacy or accuracy of this release.

About Psyched Wellness Ltd.:

Psyched Wellness Ltd. is a Canadian-based health supplements company dedicated to the distribution of mushroom-derived products and associated consumer packaged goods. The Company’s objective is to create premium mushroom-derived products that have the potential to become a leading North American brand in the emerging functional food category. The Company is in the process of developing a line of Amanita Muscaria-derived water-based extracts, teas and capsules designed to help with three health objectives: promote stress relief, relaxation and assist with restful sleeping.

Cautionary Statement Regarding Forward-Looking Information

This press release contains “forward-looking information” within the meaning of applicable Canadian securities legislation. These statements relate to future events or future performance. The use of any of the words “could”, “intend”, “expect”, “believe”, “will”, “projected”, “estimated” and similar expressions and statements relating to matters that are not historical facts are intended to identify forward-looking information and are based on the Company’s current belief or assumptions as to the outcome and timing of such future events. The forward-looking information and forward-looking statements contained herein include, but are not limited to, statements regarding: the ability of the Company to develop Amanita Muscaria-derived products; the safety of Amanita Muscaria consumption and the safety and purity of any extracts thereof; the uses and potential benefits of Amanita Muscaria; the Company executing its plan to have its AME-1-derived consumer products on shelves in the US market in the second quarter of 2022; the Company completing the GRAS review process upon the terms and timelines as disclosed herein; the Company following its regulatory strategy and submitting the associated applications as disclosed herein; the Company running parallel paths and selling in multiple food categories and jurisdictions; and the Company becoming a leading North American brand in the emerging functional food category.

Forward-looking information in this news release are based on certain assumptions and expected future events, namely: the Company’s ability to continue as a going concern; the Company’s ability to continue to develop its mushroom-derived products and associated consumer packaged goods; continued approval of the Company’s activities by the relevant governmental and/or regulatory authorities; the continued growth of the Company; the Company executing its plan to have its AME-1-derived consumer products on shelves in the US market in the second quarter of 2022; the Company completing the GRAS review process upon the terms and timelines as disclosed herein; the Company following its regulatory strategy and submitting the associated applications as disclosed herein; the Company running parallel paths and selling in multiple food categories and jurisdictions; and the Company becoming a leading North American brand in the emerging functional food category.

These statements involve known and unknown risks, uncertainties and other factors, which may cause actual results, performance or achievements to differ materially from those expressed or implied by such statements, including but not limited to: the potential inability of the Company to continue as a going concern; risks associated with potential governmental and/or regulatory action with respect to the Company’s operations; competition within the psychedelics market; risks with respect to the safety of Amanita Muscaria consumption and the safety and purity of any extracts thereof; the risk that there is no potential benefit of Amanita Muscaria consumption; risks that the Company will be unable to execute its plan and will not have its AME-1-derived consumer products on shelves in the US market in the second quarter of 2022; risk that the Company will be unable to complete the GRAS review process upon the terms and timelines as disclosed herein; risks that the Company will be unable to follow or will deviate from its regulatory strategy and be unable to submit some or all of the associated applications as disclosed herein; risk that the Company will be unable to run parallel paths and sell in multiple food categories and jurisdictions; and risks that the Company will not become a leading North American brand in the emerging functional food category.

Readers are cautioned that the foregoing list is not exhaustive. Readers are further 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 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.

Forward-looking statements contained in this news release are expressly qualified by this cautionary statement and reflect the Company’s expectations as of the date hereof and are subject to change thereafter. The Company undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, estimates or opinions, future events or results or otherwise or to explain any material difference between subsequent actual events and such forward-looking information, except as required by applicable law.

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HAVN Life Successfully Exports Psilocybin From Jamaica Facility Into the U.S. For Research Purposes

HAVN Life Successfully Exports Psilocybin From Jamaica Facility Into the U.S. For Research Purposes

The Company was able to export naturally derived psilocybin to their California-based Supply Partner, Mycrodose Therapeutics late last week.

Vancouver, BC – Havn Life Sciences Inc. (CSE: HAVN) (OTC: HAVLF) (FSE: 5NP) (the “Company” or “Havn Life”), a biotechnology company pursuing standardized extraction of psychedelic compounds for investigational research as potential active pharmaceutical ingredients (APIs) to support brain health, is pleased to announce it has successfully exported naturally derived psilocybin from its facility in Jamaica into the U.S.

HAVN Life’s operations in Jamaica are facilitated by strategic partnerships with Hypha Wellness and P.A. Benjamin Manufacturing Company to provide cultivation and processing facilities for psilocybin-containing mushrooms for authorized research purposes.

The importation of the naturally derived psilocybin into California was completed after the Company’s supply partner Mycrodose Therapeutics was granted an import license from the United States Drug Enforcement Administration (DEA). Mycrodose will be acting as a distributor for HAVN Life’s naturally-derived psilocybin in the United States, allowing the Company to fulfill the various supply agreements it has in place.

“With their track-record of working with the U.S. Food and Drug Administration (“FDA”), a proven track record of core business fundamentals, and registration with the DEA, Mycrodose Therapeutics is an ideal supply partner for HAVN Life,” says CEO Tim Moore. “Having a supply partner that gives us access to the rapidly growing U.S. market for research purposes is absolutely key for us as we look to expand our business in 2022,” he adds.

The successful import by Mycrodose Therapeutics in the U.S. comes on the heels of HAVN Life’s recent announcement of the import of naturally derived psilocybin into Canada by their supply partner, Nectar Health Sciences Laboratory Division Inc., signalling a ramping up of supply chain activities and positioning HAVN Life as an early mover with its ability to supply companies with high-quality, naturally derived psilocybin for investigational research for potential therapeutic purposes.

“This partnership helps support our company’s ambitious product development and R&D milestones by offering a potential alternative to synthetic derived psilocybin at a fraction of the cost for use in investigational research,” says Mycrodose Therapeutics CEO Chad Conner. “Most importantly, our partnership with HAVN Life helps address supply chain issues with obtaining GMP psilocybin for our own research and the research of other US-based Institutions researching psychedelics for authorized purposes,” he adds.

An MOU between HAVN Life and Mycrodose Therapeutics was announced in September, kickstarting a supply and distribution partnership that is now fully operational. The partnership will allow HAVN Life to provide naturally derived GMP psilocybin in the U.S. for authorized research purposes at competitive prices, and aims to help ease supply chain issues currently facing hundreds of pharmaceutical companies, research institutions, and nonprofits across the United States of American that cannot find psilocybin for authorized research purposes at an affordable price.

The supply of psilocybin to Mycrodose therapeutics will be in compliance with all applicable rules and regulations of the U.S. Drug Enforcement Administration.

###

On Behalf of The Board of Directors
Tim Moore
Chief Executive Officer

About HAVN Life Sciences Inc.

HAVN Life Sciences is a Vancouver, British Columbia based biotechnology company pursuing standardized extraction of psychedelic compounds to investigate their potential use as active pharmaceutical ingredients (APIs) to support brain health, along with non-psychedelic mushroom extracts as natural health products.

Through its research division, HAVN Labs, the company has developed an end-to-end supply chain of standardized, naturally derived psychedelic compounds for investigation use for potential therapeutic purposes. Additionally, HAVN Life offers a new line of high-quality non- psychedelic mushroom and plant nutritional supplements that help support healthy immune function and support a healthy lifestyle.*

Purchase our products and find out more at yourhavnlife.com, and follow us on Facebook, Twitter, Instagram and Youtube.

* These statements have not been evaluated by the Food and Drug Administration. These products are not intended to diagnose, treat, cure, or prevent any disease.

About Mycrodose Therapeutics

Mycrodose Therapeutics 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 and been approved by the United States Drug Enforcement Administration (DEA), State of California Attorney General’s Research Advisory Board, and The US Food & Drug Administration (FDA) to research four (4) psychedelic compounds: psilocybin, LSD, MDMA, and DMT. The company believes that its IP-Protected Sustained Microdosing Technology™ is a smarter and safer approach to delivering pharmaceutical compounds to patients of all ages and allows for an expandable and scalable business model.

Contact:

Investor Relations: ir@havnlife.com 604 687-7130
Media: savi@emergence-creative.com 647 896-8078

Forward-Looking Information: This news release contains “forward-looking information” within the meaning of applicable securities laws relating to statements regarding the exportation and importation of psilocybin-containing mushrooms, compliance with [the rules and regulations of the U.S. Drug Enforcement Administration] (the “[DEA] Compliance”), investigational research of psychedelic compounds for potential therapeutic purposes, Company’s business, products and future of the Company’s business. Although the Company believes that the expectations reflected in the forward-looking information are reasonable, there can be no assurance that such expectations will prove to be correct. Readers are cautioned not to place undue reliance on forward-looking information. Such forward-looking statements are subject to risks and uncertainties that may cause actual results, performance and developments to differ materially from those contemplated by these statements depending on, among other things, the risk that the continued exportation and importation of psilocybin-containing mushrooms may not be completed as contemplated, or at all, risks that the Company may not be able to obtain or maintain DEA Compliance as contemplated, or at all, risks that the Company’s products and plan will vary from those stated in this news release and the Company may not be able to carry out its business plans as expected. Except as required by law, the Company expressly disclaims any obligation and does not intend to update any forward-looking statements or forward-looking information in this news release. Although the Company believes that the expectations reflected in the forward-looking information are reasonable, there can be no assurance that such expectations will prove to be correct. The statements in this news release are made as of the date of this release.

The CSE has not reviewed, approved or disapproved the content of this press release.

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Your relatives 🤬 Christmas 🎄 and Psychedelics 🍄: issue 27

Here’s what’s in store for you in today’s issue:

🍄 First psychedelic studies program in Canada

🍄 How to cure depression in two hours 🤯

🍄 Psilocybin works twice as well as nicotine patches!

🍄 Two stock that could quadruple in price 📈

🍄 And more.

Be sure to check out this week’s Daily Mushroom podcast:

Can DMT really help cure addiction?

In this episode of the Daily Mushroom Podcast, we have David Mayoh, communication manager for Entheon Biomedical. David talks about how psychedelic therapy changed his life and how DMT can help those who are suffering from addiction.

How to cure depression in two hours

GH Research (GHRS) discovered that the most powerful psychedelic, 5-MeO-DMT (aka toad venom), is highly effective at curing treatment-resistant depression.

Out of eight patients, seven were in remission from depression just one day after receiving the company’s proprietary formulation, and five of those were in remission in as little as two hours. 

All eight patients showed improved depression scores, with an average reduction of 76%. 

Psilocybin works twice as well as nicotine patches!

Dr. Matthew Johnson’s research found that 59% of nicotine-addicted patients remained abstinent from smoking for 12 months after receiving a single macrodose of psilocybin. Only 28% of patients on a nicotine patch remained abstinent for the same time period.

His other research shows that multiple psilocybin doses can have an 80% success rate!

Psychedelics → spirituality → emotional regulation → happiness

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.

Reboot your brain 

Marcus Capone, a former Navy SEAL who was battling PTSD, finally got his life back after travelling to Mexico for an ibogaine treatment. 

He instantly felt like a huge weight had been lifted, as if his brain “was rebooted like a new operating system.”

“You can’t hide from the medicine. It’s going to reach down and it’s going to pull out everything that is affecting you,” he explains.

Ibogaine is a psychedelic substance found in the root  bark of the iboga tree! Learn more here.

The first psychedelic studies program in Canada

This semester, the University of Ottawa launched a three-course “microprogram” on Psychedelics and Spirituality. The school will offer a master’s program in psychedelics in the fall of 2022 and aims to develop a Ph.D. program after that!

Why?

“I was getting emails almost on a daily basis from people who wanted to know how they could become psychedelic therapists,” said Dr. Monica Williams, who created the program.

US government studies ibogaine

Delix Therapeutics, a private Boston-based company, is partnering with The National Institute on Drug Abuse (NIDA) to develop a treatment for substance abuse. The partnership will evaluate Delix’s non-hallucinogenic formulation of ibogaine, which has already shown promise of reducing alcohol- and heroin-seeking behavior.

BetterLife Pharma (BETR) found that its LSD formulation successfully increased exploratory and grooming behaviours in rats, two indicators of an antidepressant effect.

atai Life Sciences (ATAI) launched TryptageniX, a majority-owned joint venture with CB Therapeutics that will focus on discovering new compounds, both psychedelic and non-psychedelic.

Mycotopia Therapies (TPIA) is planning a $360M merger with Ei.Ventures to form PSLY.COM and intends to list on the NASDAQ. The new company would focus on Ei.Ventures’ flagship product Psilly, which combines psilocybin with other plant and fungi extracts for a synergistic effect.

Vine Ventures and MAPS formed a $70M special purpose vehicle called the Regenerative Financing Vine to fund MDMA research for PTSD and promote patient access.

An analyst at H.C. Wainwright predicted that Field Trip Health’s (FTRP) and COMPASS Pathways’ (CMPS) stocks could quadruple in value in the next 12 months! 🤑

GH Research (GHRS) and Numinus Wellness (NUMI) announced their financial highlights.

legal banner

Here’s what you missed in the legal world:

The Drug Enforcement Administration (DEA) and National Institute On Drug Abuse (NIDA) showed support for Biden’s plan to accelerate research on cannabis and certain psychedelics. The plan would reduce the requirements to research Schedule I substances, making them more similar to the Schedule II requirements. Read more…

 

4,000% of your daily vitamin D

The majority of people are deficient in vitamin D. Mushrooms could provide a solution!

Wild mushrooms are rich in the vitamin, but commercial production (which is often done in the dark) reduces concentration levels.

Scientists discovered that exposing mushrooms to UV radiation can increase vitamin D levels to over 4,000% of your daily value per serving! The exposure also causes mushrooms to produce more antioxidants and anti-inflammatory molecules.

Industry Quick Hits

Dec 6 – Novamind (NM) Opens New Salt Lake City Clinic with Specialized Focus on Substance Use Disorders Read more…

Dec 6 – Mydecine (MYCO) Files Full Patent Application Covering Multiple Families of Psilocin Analogs Read more…

Dec 8 – Ketamine One (MEDI) Adds Seattle Location To US Clinical Network Read more…

Dec 8 – Silo Wellness (SILO) Announces U.S. DTC Eligibility Read more…

Dec 8 – Nue Life announces donations to MAPS and Ketamine Research Foundation  Read more…

Dec 9 – Cannabis company Nextleaf Solutions (OILFF) Receives a Controlled Substance Dealers License Read more…

Video of the Week

Chinese mushrooms grown in 'smart greenhouses' spur multimillion dollar business

Playlist of the Week

Psychedelic Chill
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How to cure depression in two hours

GH Research Announces Successful Outcome of the Phase 2 part of its Phase 1/2 Clinical Trial of GH001 in Treatment-Resistant Depression

GH Research (GHRS) discovered that the most powerful psychedelic, 5-MeO-DMT (aka toad venom), is highly effective at curing treatment-resistant depression.

Out of eight patients, seven were in remission from depression just one day after receiving the company’s proprietary formulation, and five of those were in remission in as little as two hours. 

All eight patients showed improved depression scores, with an average reduction of 76%. 

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Seelos Therapeutics Announces Issuance of Composition of Matter Patent in Japan for SLS-007

Seelos Therapeutics Announces Issuance of Composition of Matter Patent in Japan for SLS-007

NEW YORK, Dec. 6, 2021 /PRNewswire/ — Seelos Therapeutics, Inc. (Nasdaq: SEEL), a clinical-stage biopharmaceutical company focused on the development of therapies for central nervous system disorders and rare diseases, announced today that it has received an issued patent from the Japanese Patent Office (Japanese patent number 6968839, titled: STRUCTURE-BASED PEPTIDE INHIBITORS OF ALPHA-SYNUCLEIN AGGREGATION), covering the composition of matter for SLS-007, a potentially disease-modifying gene therapy focused on intracellular alpha-synuclein (α-synuclein) aggregation in Parkinson’s disease (PD).

Seelos is currently conducting in vivo pre-clinical studies delivering SLS-007 via an adeno-associated virus (AAV) that is designed to target the non-amyloid component core (NACore) of α-synuclein to inhibit abnormal aggregation and accumulation of the α-synuclein protein in the brains of patients with Parkinson’s Disease (PD). The preclinical studies are designed to establish the in vivo pharmacokinetic and pharmacodynamic profiles and target engagement parameters of SLS-007.

As previously announced, Seelos was issued a composition of matter patent for SLS-007 in the U.S. in October 2020.

About SLS-007

SLS-007 is a family of rationally designed peptidic inhibitors that target the NACore of α-synuclein to inhibit abnormal aggregation and accumulation of this protein in the brains of patients with PD. The overexpression of α-synuclein leads to the formation of α-synuclein aggregates which comprise Lewy bodies and neurites which are the hallmarks of the pathogenesis of PD. Recent in vitro and cell culture research have shown that SLS-007 has the potential to stop the propagation and seeding of α-synuclein aggregates.

Forward Looking Statements

Statements made in this press release, which are not historical in nature, constitute forward-looking statements for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. These statements include, among others, those regarding the potential for SLS-007 to be a disease-modifying gene focused on intracellular α-synuclein aggregation in PD, the initiation and completion of the preclinical study of SLS-007, the ability of SLS-007 and related peptides to slow the progression of PD by stopping the seeding and potential propagation of α-synuclein aggregates, expectations regarding the results of the study, including the establishment of the in vivo pharmacokinetic and pharmacodynamics profiles and target engagement parameters of SLS-007. These statements are based on Seelos’ current expectations and beliefs and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Risks associated with Seelos’ business include, but are not limited to, the risk of not successfully executing its preclinical and clinical studies and not gaining marketing approvals for its product candidates, the risk that prior test results may not be replicated in future studies and trials, the risks that clinical study results may not meet any or all endpoints of a clinical study and that any data generated from such studies may not support a regulatory submission or approval, the risks associated with the implementation of a new business strategy, the risks related to raising capital to fund its development plans and ongoing operations, risks related to Seelos’ current stock price, risks related to the global impact of COVID-19, as well as other factors expressed in Seelos’ periodic filings with the U.S. Securities and Exchange Commission, including its Annual Report on Form 10-K and Quarterly Reports on Form 10-Q. Although we believe that the expectations reflected in our forward-looking statements are reasonable, we do not know whether our expectations will prove correct. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, even if subsequently made available by us on our website or otherwise. We do not undertake any obligation to update, amend or clarify these forward-looking statements, whether as a result of new information, future events or otherwise, except as may be required under applicable securities laws.

Contact Information:
Anthony Marciano
Chief Communications Officer
Seelos Therapeutics, Inc. (Nasdaq: SEEL)
300 Park Ave., 2nd Floor
New York, NY 10022
(646) 293-2136
anthony.marciano@seelostx.com 
www.seelostherapeutics.com
https://twitter.com/seelostx 
https://www.linkedin.com/company/seelos

SOURCE Seelos Therapeutics, Inc.

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GH Research Announces Successful Outcome of the Phase 2 part of its Phase 1/2 Clinical Trial of GH001 in Treatment-Resistant Depression

GH Research Announces Successful Outcome of the Phase 2 part of its Phase 1/2 Clinical Trial of GH001 in Treatment-Resistant Depression

  • Primary endpoint met in Phase 2 part of clinical trial for GH001 in TRD
    • 7 of 8 patients (87.5%) were in remission (MADRS ≤10) at day 7 after dosing (p<0.0001)
  • Secondary endpoints met
    • Mean change from baseline in MADRS at day 7 after dosing was -24.4 points (-76%) (p<0.0001)
    • GH001 was well tolerated and no serious adverse events were reported
  • In addition, we announce positive preliminary safety results from a Phase 1 clinical pharmacology trial of GH001 in 46 healthy volunteers with 30-day follow-up supporting the safety profile of GH001 beyond day 7.

DUBLIN, Ireland, Dec. 06, 2021 (GLOBE NEWSWIRE) — GH Research PLC (Nasdaq: GHRS), a clinical-stage biopharmaceutical company dedicated to transforming the treatment of psychiatric and neurological disorders, today reported the successful outcome of the Phase 2 part of a Phase 1/2 clinical trial of GH001, an inhalable 5-MeO-DMT product candidate, in patients with treatment-resistant depression (TRD) (GH001-TRD-102).

The primary endpoint of the Phase 2 part of the trial was met with 7 of 8 patients (87.5%) in remission (Montgomery–Åsberg Depression Rating Scale (MADRS) ≤10) at day 7 after dosing (p<0.0001). According to FDA Guidance for Industry, a 7-day endpoint is an appropriate primary efficacy endpoint for rapid-acting antidepressants.

The Phase 2 part of the clinical trial recruited 8 patients. The median age was 34 years. The median baseline severity of depression by MADRS was 32.

Patients followed a proprietary GH001 individualized dosing regimen administered on a single day with up to three increasing doses of GH001 (6 mg, 12 mg and 18 mg). The second and third doses were only administered in the event that the patient did not achieve a peak experience1 (PE) at the previously administered dose. Based on this trial design, 6 patients received 6 mg and 12 mg doses of GH001 and 2 patients received 6 mg, 12 mg and 18 mg doses of GH001. 7 patients were able to achieve a PE at their final dose, and at this final dose the mean PE total score was 90.4.

Of the 7 patients who had a remission at day 7, all were in remission beginning on day 1, with 5 in remission as early as 2 hours after dosing. The single patient who did not achieve a remission at day 7, also improved on day 7 versus baseline. 6 of the 7 patients in remission had achieved a PE at their final dose. The mean MADRS change from baseline for all 8 patients at day 7 was -24.4 points (-76%) (p<0.0001).

Compared with the single dose results in the previously reported Phase 1 part of the trial (12 mg, n=4; 18 mg, n=4), the proprietary GH001 individualized dosing regimen increased the rate of MADRS remission at day 7, increased the mean MADRS absolute change from baseline at day 7, increased the rate of PE, and increased the mean PE score achieved.

In accordance with the trial protocol, a study safety group (SSG) was established, including external experts, to evaluate the safety data for the clinical trial. All patients completed all planned visits. No serious adverse events (SAE) were reported. 7 of 8 patients (87.5%) experienced at least one adverse drug reaction (ADR), all of which were mild (81%) or moderate (19%) in intensity, and all of which resolved spontaneously. The ADRs reported were: headache, sensory disturbance (each in 3 patients), anxiety, flashback, nausea (each in 2 patients), muscle discomfort, abdominal discomfort, paresthesia, depressive symptom (each in 1 patient). Based on the full safety results of the trial, the SSG concluded that no unexpected or severe adverse effects and no clinically significant changes were observed in any of the safety laboratory analyses, vital signs, psychiatric safety assessments or measures of cognitive function and that no signal for suicidal ideation or behavior was observed.

Safety Results from Phase 1 Clinical Pharmacology Trial in Healthy Volunteers

In addition, we also reported positive preliminary safety results from a Phase 1 clinical pharmacology trial in healthy volunteers (GH001-HV-103).

This trial enrolled 46 healthy volunteers with 30-day safety follow-up. The trial investigated three different single doses of GH001 in a double-blind, placebo-controlled design (6 mg (n=8), 12 mg (n=8), 18 mg (n=8), placebo (n=2 in each dose group)) and a proprietary GH001 individualized dosing regimen with intra-subject dose escalation within a single day in an open-label, non-randomized design in two groups with two different intervals between doses (1 hour (n=8), 2 hours (n=8)).

All subjects completed all planned visits. No SAEs were reported. 11 of 24 subjects (45.8%) who received GH001 in the single-dose part and 0 of 6 subjects (0%) who received placebo in the single-dose part experienced at least one ADR. In the multiple-dose part, 7 of 16 subjects (43.8%) who received GH001 experienced at least one ADR. All ADRs were mild and all ADRs resolved spontaneously. In the single-dose part, the ADRs reported were: headache (in four participants), tachycardia, crying (each in two participants), chest discomfort, dizziness, dry mouth, dyskinesia, fatigue, hypoesthesia oral, retching, somnolence, tremor (each in one participant). In the multiple dose part, the ADRs reported were: fatigue (in three participants), headache (in two participants), abnormal dreams, paresthesia oral, crying, tension (each in one participant). No clinically relevant changes were observed for vital parameters, peak expiratory flow rate, safety laboratory analyses, ECG and psychiatric safety assessments.

The preliminary results of this 30-day trial support the safety profile of GH001 single doses and the proprietary GH001 individualized dosing regimen with intra-subject dose escalation within a single day. Final source data verification, the pharmacokinetic analyses and analyses of various secondary endpoints are still ongoing. The full results from this trial are intended to support the selection of the optimal dosing interval for the individualized dosing regimen in future studies of GH001.

1The occurrence of peak experiences (PE) is assessed using a proprietary visual analogue scale (PE scale), which averages answers scored by the patient from 0 to 100 for three parameters of the experience: intensity, feelings of loss of control and profoundness. A PE is defined as a total score of at least 75 on this scale.

About GH Research PLC

GH Research PLC is a clinical-stage biopharmaceutical company dedicated to transforming the treatment of psychiatric and neurological disorders. GH Research PLC’s initial focus is on developing its novel and proprietary 5-MeO-DMT therapies for the treatment of patients with treatment-resistant depression (TRD).

About GH001

Our lead product candidate, GH001, is formulated for 5-MeO-DMT administration via a proprietary inhalation approach. With GH001, we have completed two Phase 1 healthy volunteer clinical trials and a Phase 1/2 clinical trial in patients with treatment-resistant depression (TRD). Based on the observed clinical activity, where 87.5% of patients with TRD were brought into an ultra-rapid remission with our GH001 individualized single-day dosing regimen in the Phase 2 part of the trial, we believe that GH001 has potential to change the way TRD is treated today. Across the GH001 program, no serious adverse events have been reported and GH001 was well tolerated at the investigated single dose levels and in the individualized dosing regimen.

Forward-Looking Statements

This press release contains statements that are, or may deemed to be, forward-looking statements. All statements other than statements of historical fact included in this press release, including statements regarding our future results of operations and financial position, business strategy, product candidates, research pipeline, ongoing and currently planned preclinical studies and clinical trials, regulatory submissions and approvals, research and development costs, timing and likelihood of success, as well as plans and objectives of management for future operations are forward-looking statements. Forward-looking statements appear in a number of places in this press release and include, but are not limited to, statements regarding our intent, belief or current expectations. Forward-looking statements are based on our management’s beliefs and assumptions and on information currently available to our management. Such statements are subject to risks and uncertainties, and actual results may differ materially from those expressed or implied in the forward-looking statements due to various factors, including, but not limited to, those described in our filings with the U.S. Securities and Exchange Commission. No assurance can be given that such future results will be achieved. Such forward-looking statements contained in this document speak only as of the date of this press release. We expressly disclaim any obligation or undertaking to update these forward-looking statements contained in this press release to reflect any change in our expectations or any change in events, conditions, or circumstances on which such statements are based unless required to do so by applicable law. No representations or warranties (expressed or implied) are made about the accuracy of any such forward-looking statements.

Investor Relations
Julie Ryan
GH Research PLC
investors@ghres.com