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Treating alcoholism in Europe

Awakn Life Sciences Signs MOU with NHS (Devon Partnership NHS Trust) and University of Exeter with a View of Increasing Access to Psychedelic-Assisted Psychotherapy in the UK

Last year, Awakn Life Sciences (AWKN) found that MDMA-assisted therapy helped alcoholics reduce alcohol consumption by 85% – from an average of 130.6 units per week to just 18.7. Now, the company is exploring a partnership with the Multidisciplinary Association for Psychedelic Studies (MAPS) to treat alcohol use disorder across Europe, where alcohol is one of the top five causes of disease and disability in most countries. Awakn may license MAPS’ pre-clinical data to get the treatment to market faster.
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Field Trip Health Ltd. Reports Second Fiscal Quarter 2022 Financial Results and Provides Business Update

Field Trip Health Ltd. Reports Second Fiscal Quarter 2022 Financial Results and Provides Business Update

  • Announced plans to advance FT-104, its novel psychedelic compound, to clinic for Treatment-Resistant Depression and Postpartum Depression as the lead indications.
  • Initiated a new pipeline research program focused on discovering novel psychedelics with a reduced cardiovascular risk profile compared to classic psychedelics (the “FT-200 Group”) and filed a provisional patent in connection to the composition of matter for the first molecule identified in the FT-200 Group.
  • Continued to invest in best-in-class clinical infrastructure, with nine clinics currently in operation and nine locations under construction or about to commence construction.
  • Commenced trading on the NASDAQ Global Select Market (“NASDAQ”) under the ticker symbol “FTRP”.
  • As at September 30, 2021, Field Trip had approximately $88 million in unrestricted cash and cash equivalents and short-term investments.
  • Commenced a strategic review of the current corporate structure to assess options to maximize the value of the drug development and therapy delivery business units.

TORONTO, Nov. 15, 2021 (GLOBE NEWSWIRE) — Field Trip Health Ltd. (TSX: FTRP; FTRP.WT; NASDAQ: FTRP) (“FieldTrip“), a leader in the development and delivery of psychedelic therapies, reported its second fiscal quarter 2022 results for the three months ended September 30, 2021 and provided a business update. All results are reported under International Financial Reporting Standards (“IFRS“) and in Canadian dollars, unless otherwise specified.

Key Highlights and Recent Developments

During the quarter, Field Trip progressed its strategy of building a leading psychedelic therapy company (Field Trip Health) and continued to invest in its drug development pipeline and program expansion (Field Trip Discovery).

Field Trip Discovery

FT-104

During the quarter, it was announced that the lead indications for FT-104, Field Trip’s lead novel psychedelic compound in development (patent pending), will be Treatment Resistant Depression and Postpartum Depression. FT-104 is a novel, synthetic 5HT2A receptor agonist compound. It is currently advancing through preclinical studies with the in vivo portion completed, and final results from safety pharmacology and GLP toxicology are expected in calendar Q4 2021. To date, GLP toxicology, cardiovascular, pulmonary, and neurological safety pharmacology studies, as well as genotoxicity potential, all continue to be encouraging. In addition, final manufacturing of clinical trial material is scheduled for production to enable FT-104 to move into Phase 1 clinical trials in the first half of calendar 2022. The Company has experienced, and may continue to experience, delays in initiating Phase 1 clinical trials due to the ongoing COVID pandemic and delays at its contract manufacturing organization.

FT-200 Group: Introducing Field Trip’s Second Novel Psychedelic Program

The Company also announced the discovery of a novel molecule that, based on in vivo assay details, has the structure of classical psychedelics and has demonstrated improved selectivity for the target serotonin 2A receptor (5HT2A) relative to FT-104 and psilocybin versus off target serotonin, 5HT1A, 5HT2B and 5HT2C receptors. This is meaningful because off-target 5HT2B activity has been associated with increased risk of cardiovascular toxicity. Based on this discovery, the Company is expanding the scope of its development pipeline to focus on a new group of molecules termed the FT-200 Group, (which includes the molecule mentioned above), that have the structure of classical psychedelics, with similar potency at the 5HT2A receptor as FT-104 and psilocybin, but with reduced or the absence of activity at the off-target 5HT2B receptor. The aim of the work is that by reducing or eliminating 5HT2B activity it may allow molecules like those in the FT-200 Group to be administered more frequently, such as more chronic or chronic intermittent administration or ‘microdosing’ strategies.

“The first molecule identified in the FT-200 Group demonstrates significant promise to maintain 5HT2A activity while reducing off-target serotonin receptor activity. We are continuing to conduct preclinical work on this molecule and will explore structural analogs within the FT-200 Group to better refine and optimize this new family of substances, understand their properties better and work towards identifying a lead candidate”, said Joseph del Moral, Field Trip’s Co-founder and CEO.

On October 29, 2021 the Company filed a provisional patent application in the United States to protect the composition, as well as potential formulations and uses of the first molecule in the FT-200 group.

Field Trip Health Centres

Leveraging the growing awareness of Field Trip’s psychedelic-assisted therapy clinics, Field Trip announced on August 31, 2021 the launch of the KAP Co-operative Program (“KAP Co-op”), a program that enables eligible independent psychedelic therapists to provide ketamine-assisted psychotherapy (and, in the future, other legal, psychedelic-assisted therapies) at its Field Trip Health Centres. Field Trip also announced the launch of training programs designed to provide interested psychotherapists or other qualified mental health professionals and clinicians with access to best-in-class training on KAP.

The Company continues to invest in its clinics and during the quarter, entered into lease agreements for locations in Dallas, TX, Miami, FL and Scottsdale, AZ. Subsequent to the quarter end, the Company announced the opening of the Seattle, WA clinic, its sixth in the United States and ninth overall, along with the recent opening of a location in Fredericton, NB, and the imminent opening of a location in Vancouver, BC.

Hannan Fleiman, Field Trip’s Co-Founder and President, said, “We continue to see strong growth in our clinic business and our team is proud of the outcomes we are helping our patients achieve. We have continued to make significant investments in building out the leading platform for the delivery of psychedelic therapies and to position our clinics to be at the absolute forefront of our industry in establishing the critical infrastructure for the current and emerging psychedelic therapies with 9 clinics now in operation and 9 locations under construction or about to commence construction. Importantly, the clinics enable Field Trip to capture significant amounts of patient data on clinical outcomes which we expect to help inform future clinical development and treatment strategies.”

From a brand perspective, Field Trip continues to be a globally recognized company in the industry. During the quarter, the Company was featured in many top-tier print and broadcast media outlets, including Forbes, Vox Media, Insider, People and others, generating nearly 2 billion total potential media impressions. Field Trip’s brand presence and reach continues to generate strong website traffic and patient interest in the KAP treatments offered by the Company.

NASDAQ Listing

On July 29, 2021, Field Trip’s Common Shares commenced trading on the NASDAQ Global Select Market (“NASDAQ”) under the ticker symbol “FTRP”, providing the Company with greater access to capital. The Common Shares continue to trade in Canada on the TSX under its current symbol FTRP. Concurrent with the NASDAQ listing, Field Trip’s Common Shares ceased to be quoted on the OTCQX. The Company previously completed the process to ensure its shares are eligible for electronic clearing and settlement through the Depository Trust Company (DTC). In addition, Ronan Levy and Ellen Lubman joined the Compensation Committee and Mujeeb Jafferi and Dr. Ryan Yermus resigned as directors of the Company. Mr. Jafferi and Dr. Yermus continue to serve as Field Trip’s Chief Operating Officer and Chief Clinical Officer, respectively.

Mr. del Moral, continued, “The milestone of listing on NASDAQ during the quarter was testament to the rapid progress we have made and increased our visibility in the marketplace, improving trading liquidity and ultimately enhancing long term shareholder value as we further strengthen our leadership position in the psychedelic medicine industry.”

Strategic Review of Corporate Structure

The Company has commenced a strategic review designed to ensure that each operating unit is best positioned, optimally resourced, and focused to provide maximum long-term value to all stakeholders.

Mr. Joseph del Moral, said, “With the FT-104 nearing the clinic, the expansion of discovery efforts around our FT-200 Group, and the growing number of opportunities for Field Trip Health Centers we believe it is the correct time to review all strategic options to ensure we continue to maximize the growth potential and value of each business unit.”

The Company has engaged Bloom Burton Securities Inc. as its financial advisor in connection with the strategic review.

Financial Highlights

For the second fiscal quarter ended September 30, 2021, the Company earned patient services revenues of $907,816 from its Toronto, New York, Santa Monica, Chicago, Atlanta, Houston and Amsterdam clinics, an increase of $813,284 or 860% over the comparative quarter ended September 30, 2020 of $94,532 and an increase of $40,416 or 5% over the prior fiscal first quarter. The Amsterdam clinic began generating revenues in September 2021. Second fiscal quarter 2021 patient services revenues were generated from only two clinics, Toronto and New York. The modest quarter over quarter revenue increase was in part due to the COVID-19 Delta variant and seasonality associated with the slower summer months. Revenues in the first part of the third quarter indicate a clear upward trend as a result of recent process optimizations to accelerate patient on-boarding and increase clinic capacity.

Net loss for the second fiscal quarter of $13,019,280 was primarily due to total operating costs of $15,638,596, of which $2,055,890 was related to non-cash share-based compensation and $848,712 was related to non-cash depreciation and amortization. This was partially offset by a foreign exchange gain of $1,856,088. This compares with a net loss of $3,932,444 in the second fiscal quarter of 2021. The increase from the prior year primarily reflects the Company’s focus on growing the business and continued investment in its drug development pipeline and best-in-class clinic infrastructure. As the Company continues to scale, it is optimizing and streamlining the development of its psychedelic-assisted therapies.

Total operating costs in the second fiscal quarter were $15,638,596 and were comprised of the following: general and administration expenses of $8,917,717, research and development expenses of $2,102,787, patient services expenses of $1,917,451, sales and marketing expenses of $1,315,434, depreciation and amortization of $848,712 and occupancy costs of $536,495. This compares with total operating costs of $3,810,177 in the second fiscal quarter of 2021.

The difference in general and administrative expenses in the second fiscal quarter also included $596,055 in non-recurring expenses primarily related to the NASDAQ uplisting, $1,330,847 in recurring public company costs as well as non-cash share-based payments of $1,380,398.

Balance Sheet

As of September 30, 2021 Field Trip had unrestricted cash and cash equivalents, funds held in trust and short-term investments of $87,526,034.

Selected Consolidated Financial Information

The following table sets forth selected financial information derived from the Company’s unaudited condensed interim financial statements for the three months and six months ended September 30, 2021 prepared in accordance with IAS 34 in a manner consistent with the Company’s annual audited financial statements. The following information should be read in conjunction with the financial statements and management’s discussion and analysis, which are available on the Company’s website at www.fieldtriphealth.com and under the Company’s SEDAR profile at www.sedar.com.

FIELD TRIP HEALTH LTD

STATEMENTS OF LOSS AND COMPREHENSIVE LOSS

3 months ended 3 months ended 6 months ended 6 months ended
September 30,
2021		 September 30,
2020		 September 30,
2021		 September 30,
2020
$ $ $ $
Revenue
Patient services 907,816 94,532 1,775,216 118,131
907,816 94,532 1,775,216 118,131
Operating Expenses
General and administration 8,917,717 2,092,593 16,260,688 3,366,948
Occupancy costs 536,495 111,877 913,110 175,660
Sales and marketing 1,315,434 281,185 2,379,561 435,940
Research and development 2,102,787 806,536 3,555,901 1,601,898
Depreciation and amortization 848,712 269,578 1,464,195 479,338
Patient services 1,917,451 248,408 3,375,272 321,665
Total Operating Expenses 15,638,596 3,810,177 27,948,727 6,381,449
Other Income (Expenses)
Interest income 111,934 2,589 243,549 4,838
Interest expense (256,522 ) (60,962 ) (403,109 ) (98,195 )
Other income (expense) 1,856,088 (158,426 ) 783,396 (534,673 )
Net Loss (13,019,280 ) (3,932,444 ) (25,549,675 ) (6,891,348 )
Net Loss per Share – Basic and Diluted (0.23 ) (0.16 ) (0.44 ) (0.28 )

 

As at
September 30,
2021
$		 As at
March  31,
2021
$
Cash and cash equivalents 22,388,946 38,469,057
Funds held in trust – 795,516
Restricted cash 619,127 588,041
Short-term investments 65,137,088 72,552,870
Accounts receivable 2,464,223 813,761
Total Assets 119,912,854 126,450,005
Total Non-Current Financial Liabilities 18,102,184 6,426,484

Certain comparative figures have been reclassified where necessary to conform with current period presentation.

Conference Call

The Company will conduct a conference call and webcast to discuss its results the following morning, Tuesday, November 16 at 8:30 am ET. To access the call, please dial 1-877-407-9716 (within the U.S.) or 1-201-493-6779 (outside the U.S.) and provide conference ID 13724604. A live webcast of the conference call can be accessed via the Events and Presentations section of the Field Trip Health Investor Relations website here.

For those unable to attend the live call, a telephonic replay will be available until 11:59 pm ET on Tuesday, November 30, 2021. To access the replay of the call dial 1-844-512-2921 (within the U.S.) or 1-412-317-6671 (outside the U.S.) and provide conference ID 13724604. An archived copy of the webcast will be available on the Events and Presentations section of the Field Trip Health Investor Relations website after the conclusion of the call.

About Field Trip Health Ltd.

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

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

Follow us on Twitter and Instagram: @fieldtriphealth.

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

Cautionary Note Regarding Forward-Looking Information  

This release includes forward-looking information (within the meaning of Canadian securities laws and within the meaning of the United States Private Securities Litigation Reform Act of 1995) regarding Field Trip and its business. Often but not always, forward-looking information can be identified by the use of words such as “expect”, “intends”, “anticipated”, “believes” or variations (including negative variations) of such words and phrases, or state that certain actions, events or results “may”, “could”, “would” or “will” be taken, occur or be achieved. Such statements are based on the current expectations and views of future events of the management of Field Trip and are based on assumptions and subject to risks and uncertainties. Although the management of Field Trip believes that the assumptions underlying these statements are reasonable, they may prove to be incorrect. The forward-looking events and circumstances discussed in this release may not occur and could differ materially as a result of known and unknown risk factors and uncertainties affecting the companies, including the timing, completion and potential outcomes of the Strategic Review, the funds available to Field Trip and the use of such funds, the ability of Field Trip to operate its clinics, the construction and commencement of construction of additional clinics, the development, patentability and viability of FT-104 and the FT-200 Group, the ability of Field Trip to complete an investigational new drug application and obtain regulatory approvals, as required, prior to initiating clinical trials for FT-104 and molecules within the FT-200 Group, the ability of Field Trip to meet eligibility requirements for clinical testing and through to more complex clinical trials, the ability of Field Trip to obtain regulatory approvals prior to each clinical trial and the ability of Field Trip to generate patient member growth, interest in the training program, interest in the KAP Co-Op Program, uptake of the KAP Co-Op Program by therapists and patients, the ability of management to sustain and continue optimization of its clinical operations, the timing and results of its research and development programs, approval of phase 1 human trials, if any, the risk that future clinical studies may not proceed as expected or may produce unfavorable results, the opening of additional clinics, the COVID-19 epidemic, the medical clinic industry, market conditions, economic factors, management’s ability to manage and to operate the business and the equity markets generally. Although Field Trip has attempted to identify important factors that could cause actual actions, events or results to differ materially from those described in forward-looking statements, there may be other factors that cause actions, events or results to differ from those anticipated, estimated or intended. Accordingly, readers should not place undue reliance on any forward-looking statements or information. No forward-looking statement can be guaranteed. Except as required by applicable securities laws, forward-looking statements speak only as of the date on which they are made and Field Trip does not undertake any obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events, or otherwise. Additional information relating to Field Trip, including its Annual Information Form, can be located on the SEDAR website at www.sedar.com and on the EDGAR section of the SEC’s website at www.sec.gov.

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

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

CONTACTS:

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

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

Investor contacts:
Kathleen Heaney / Tim Regan
KCSA Strategic Communications
fieldtripIR@kcsa.com

SOURCE Field Trip Health Ltd.

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FSD Pharma Expands Research And Clinical Advisory Board With Appointment Of World-renowned Immunologist And Cytokine Expert Dr. Eleanor N. Fish

FSD Pharma Expands Research And Clinical Advisory Board With Appointment Of World-renowned Immunologist And Cytokine Expert Dr. Eleanor N. Fish

TORONTO–(BUSINESS WIRE)– FSD Pharma Inc. (NASDAQ: HUGE) (CSE: HUGE) (FRA: 0K9) (“FSD Pharma” or the “Company”), a life sciences holding company dedicated to building a portfolio of assets and biotech solutions, today announced the appointment of Eleanor N. Fish, Ph.D., to its Research and Clinical Advisory Board.

Dr. Fish, an accomplished researcher in the areas of immunology and inflammatory disorders, and member of the Government of Canada’s Expert Scientific Panel to the Chief Scientific Advisor, brings key expertise to FSD Pharma that will support the continued development of FSD-PEA, the Company’s proprietary anti-inflammatory agent, and Lucid-MS, its drug candidate for the treatment of multiple sclerosis.

“I am delighted to welcome Dr. Eleanor Fish to our team,” said Dr. Lakshmi P. Kotra, B.Pharm. (Hons), Ph.D., Chief Executive Officer of Lucid Psycheceuticals Inc., FSD Pharma’s wholly-owned subsidiary. “A key aspect of Eleanor’s research is to better understand the onset and treatment of autoimmune diseases, such as multiple sclerosis and rheumatoid arthritis. Her expertise and insights will be extremely valuable as we continue to advance our FSD-PEA and Lucid-MS programs, and her decades of experience in translational research will greatly benefit FSD’s current and future pipelines.”

Dr. Fish serves as a Professor in the Department of Immunology at the University of Toronto; Associate Chair of International Initiatives and Collaborations at the University of Toronto; and Emerita Scientist at the Toronto General Hospital Research Institute of the University Health Network. She received a B.Sc. from the U.K.’s University of Manchester, an M.Phil. from King’s College at the University of London, and a Ph.D. from the Institute of Medical Sciences at the University of Toronto. Dr. Fish has received numerous international awards recognizing her scientific achievements and has authored more than 170 peer-reviewed scientific papers published in international journals.

“I am energized by this opportunity to assist FSD Pharma in advancing the development of its next- generation therapeutics in pursuit of a healthier world,” said Dr. Fish.

About FSD Pharma

FSD Pharma is a life sciences holding company with two wholly-owned subsidiaries dedicated to building a portfolio of diversified therapeutic assets and innovative healthcare and biotech services.

FSD BioSciences, Inc., a wholly-owned subsidiary, is a specialty biotech pharmaceutical R&D company focused on developing applications of its lead compound, ultramicronized PEA, by down-regulating the cytokines to effectuate an anti-inflammatory response.

Lucid Psycheceuticals Inc., a wholly-owned subsidiary, has exclusive worldwide rights to novel compounds shown to prevent and potentially reverse the biochemical mechanisms of progressive multiple sclerosis in multiple preclinical animal models. Additionally, FSD is seeking to develop a unique psychoactive (psychedelic-based) therapeutic aimed at addressing neurodegenerative disorders, a multibillion-dollar mental health market. The Company hopes to quickly advance its lead drug candidates through clinical trials.

Forward Looking Information

Certain statements contained herein are “forward-looking statements.” Often, but not always, forward-looking statement can be identified by the use of words such as “plans”, “expects”, “expected”, “scheduled”, “estimates”, “intends”, “anticipates”, “hopes”, “planned” or “believes”, or variations of such words and phrases, or states that certain actions, events or results “may”, “could”, “would”, “might”, “potentially” or “will” be taken, occur or be achieved. Forward-looking statements contained in this press release include the comments made with respect to advancing the Company’s research into Lucid-MS and LUCID-PSYCH toward the clinic, including the anticipated launch a Phase 1 clinical trial of Lucid-MS by the end of 2022, and the efforts to advance ultramicronized Palmitoylethanolamide and develop of applications therefor evaluation of the commercial viability of its principal drug compound. FSD cannot give any assurance that such forward-looking statements will prove to have been correct. The reader is cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release.

Since forward-looking statements relate to future events and conditions, by their very nature they require making assumptions and involve inherent risks and uncertainties. The Company cautions that although it is believed that the assumptions are reasonable in the circumstances, these risks and uncertainties give rise to the possibility that actual results may differ materially from the expectations set out in the forward-looking statements. Factors that may cause such material differences include without limitation: the fact that the drug development efforts of both Lucid and FSD BioSciences are at a very early stage; the fact that preclinical drug development is uncertain, and the drug product candidates of Lucid and FSD BioSciences may never advance to clinical trials; the fact that results of preclinical studies and early-stage clinical trials may not be predictive of the results of later stage clinical trials; the uncertain outcome, cost, and timing of product development activities, preclinical studies and clinical trials of Lucid and FSD BioSciences; the uncertain clinical development process, including the risk that clinical trials may not have an effective design or generate positive results; the potential inability to obtain or maintain regulatory approval of the drug product candidates of Lucid and FSD BioSciences; the introduction of competing drugs that are safer, more effective or less expensive than, or otherwise superior to, the drug product candidates of Lucid and FSD BioSciences; the initiation, conduct, and completion of preclinical studies and clinical trials may be delayed, adversely affected, or impacted by COVID-19 related issues; the potential inability to obtain adequate financing; the potential inability to obtain or maintain intellectual property protection for the drug product candidates of Lucid and FSD BioSciences; and other risks. Further information regarding factors that may cause actual results to differ materially are included in the Company’s annual and other reports filed from time to time with the Canadian Securities Administrators on SEDAR (www.sedar.com) and with the U.S. Securities and Exchange Commission on EDGAR (www.sec.gov) under the heading “Risk Factors.” Any forward-looking statement contained in this release speaks only as of its date. The Company does not undertake to update any forward-looking statements, except to the extent required by applicable securities laws.

 

Zeeshan Saeed, President, Founder and Director, FSD Pharma Inc.
Email: Zsaeed@fsdpharma.com
Telephone: (416) 854-8888
Investor Relations: Email: ir@fsdpharma.com, Website: www.fsdpharma.com

Source: FSD Pharma Inc.

Released November 16, 2021

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Lobe Sciences Sponsors the International Summit on Psychedelic Therapies for Mental Illness

Lobe Sciences Sponsors the International Summit on Psychedelic Therapies for Mental Illness

The largest and most important Psychedelic Medicine Conference in the Southern Hemisphere

Vancouver, British Columbia–(Newsfile Corp. – November 16, 2021) – Lobe Sciences Ltd. (CSE: LOBE) (OTC Pink: LOBEF) (“Lobe” or the “Company“) today announced that it is a Major Supporter of the upcoming International Summit on Psychedelic Therapies for Mental Illness taking place November 17-20, 2021.

Mind Medicine Australia (“MMA”) will hold a two-day online International Summit on Psychedelic Therapies for Mental Illness in November 2021 (the “Summit”), bringing together clinicians, scientists, academics, mental and public health professionals, philanthropists, investors, Government, law and policy leaders, business, industry, insurers, consumers, and other interested stakeholders. The Summit will provide the opportunity to learn from the global leaders in the psychedelic renaissance including Dr. Rick Doblin (USA), Professor Roland Griffiths (USA), Professor David Nutt (UK), Dr. Gabor Mate (Canada), Professor Robin Carhart-Harris (UK), Dr Alberto Villoldo (USA) and other thought leaders like Johann Hari.

The event will also feature a two-day pre-Summit Introductory Workshop Program (November 17-18) led by Nigel Denning, Dr. Tra-ill Dowie with world-leading therapist trainer Dr. Bill Richards (USA) from Johns Hopkins University. It is for anyone with an interest in the topic and who is considering further development of their current therapeutic skills or who are eager to gain a detailed understanding of psychedelic-assisted psychotherapy for the treatment of mental illness.

Philip Young CEO & Director of Lobe Sciences stated, “We are very happy to partner with Mind Medicine Australia by sponsoring this conference and exploring further collaborations as they seek to bring the reality of psychedelic medicine to medical practitioners and their patients in Australia.”

Executive Director of MMA Tania de Jong AM says, “There is a massive renaissance of interest in these medicines, especially now. When we started MMA there was just one commercial start-up globally; now there are new companies launching weekly. With accelerating mental illness across the community due to the Covid-19 crisis we simply do not have the tools to heal the millions who are suffering. These medicines provide potential for healing for those who have tried multiple different treatments, often over decades, without success. We are very excited to hear from the world class leaders at our Global Summit. They will share valuable insights, data and science, and educate practitioners, consumers, insurers, investors, business, industry, government, academics and the broader community about this rapidly emerging field.”

Ilan Hayman, Operations Manager of Mind Medicine Australia and Advisory Board Member of Lobe Sciences said, “Our program features a world class line-up of talks, workshops, hot spots, panel conversations and creative moments. The International Summit on Psychedelic Therapies for Mental Illness is an excellent educational opportunity to gain an in-depth understanding of this long-overdue innovation in mental healthcare. Both MDMA and psilocybin assisted therapies have been shown to be successful in treating depression, social anxiety in autistic adults, post-traumatic stress disorder (PTSD), end-of-life stress and anxiety and addiction. They are now being trialed for anorexia, obsessive-compulsive disorder (OCD), and dementia, among many other conditions. I am very happy that Lobe has partnered with Mind Medicine Australia as we seek to expand the treatment options available to medical practitioners and their patients to treat a range of chronic mental health conditions.”

For information and to register for the International Summit on Psychedelic Therapies for Mental Illness and the Psychedelic Therapist Introductory Workshop, please visit: https://summit.mindmedicineaustralia.org/.

About Mind Medicine Australia

Mind Medicine Australia was founded by social entrepreneurs Peter Hunt AM and Tania de Jong AM following their successful experience setting up other charities and working with people diagnosed with a mental illness. It is an Australian registered charity (with DGR 1 status) seeking to broaden the treatment paradigm available to medical practitioners and their patients and improve treatment effectiveness by establishing, safe, accessible and effective Psychedelic-Assisted Psychotherapy in Australia to help prevent further suffering and suicides caused by mental illness. MMA’s focus in wholly clinical.

About Lobe Sciences Ltd.

Lobe Sciences is a life sciences company focused on psychedelic medicines. The Company, through collaborations with industry-leading partners, is engaged in drug research and development using psychedelic compounds and the development of innovative devices and delivery mechanisms to improve mental health and wellness.

For further information please contact:

Lobe Sciences Ltd.

Philip J Young, CEO
info@lobesciences.com
Tel: (949) 505-5623

NEITHER THE CSE NOR ITS REGULATION SERVICES PROVIDER HAVE REVIEWED OR ACCEPT RESPONSIBILITY FOR THE ACCURACY OR ADEQUACY OF THIS RELEASE.

Disclaimer for Forward-Looking Statements

This news release contains forward-looking statements relating to the future operations of the Company 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, including statements regarding the future plans and objectives of the Company, research and development using psychedelic compounds, and the development of innovative devices and delivery mechanisms to improve mental health and wellness, are forward-looking statements that involve risks and uncertainties. This does not constitute an offer to sell or a solicitation of offers to buy any securities. 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. Readers are cautioned that assumptions used in the preparation of the forward-looking statements 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, including changes to the regulatory environment;, that the Company’s drug research and development activities may be unsuccessful; that drugs and medical devices produced by, or on behalf of, the Company, may not work in the manner intended or at all, and may subject the Company to product liability or other liability claims; that the Company may not be able to attain the Company’s corporate goals and objectives; and other risk factors detailed in the Company’s continuous disclosure filings from time to time, as available under the Company’s profile at www.sedar.com. As a result, the Company cannot guarantee that any forward-looking statement will materialize and the reader is cautioned not to place undue reliance on any forward-looking information. Forward-looking statements contained in this news release are expressly qualified by this cautionary statement. The forward-looking statements contained in this news release are made only as of the date of this news release and the Company does not intend to update any of the included forward-looking statements except as expressly required by applicable Canadian securities laws.

To view the source version of this press release, please visit https://www.newsfilecorp.com/release/103631

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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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Filament Health Reports Third Quarter 2021 Financial Results and Operational Highlights

Filament Health Reports Third Quarter 2021 Financial Results and Operational Highlights

FDA Authorization of Historic Phase I Clinical Trial Using All-Natural Psychedelic Compounds and Direct Psilocin Administration for the First Time

Granted First and Only Patent for Extraction and Standardization of Natural Psilocybin

Health Canada Dealer’s License Enables Production and Distribution of All Natural cGMP-Grade Psychedelic Supply from its Facilities

Vancouver, British Columbia, November 15, 2021  – Filament Health Corp. (OTCQB:FLHLF) (NEO:FH) (FSE:7QS) (“Filament” or the “Company”), a clinical-stage natural psychedelic drug development company, released its third quarter financial results and operational highlights for the period ended September 30, 2021.

 

Third Quarter and Post Period Operational Highlights:

FDA authorization of phase I clinical trial using naturally-sourced psychedelic substances and direct administration of psilocin (both orally and sublingually) for the first time in FDA history;

  • First and only patent granted for the extraction and standardization of natural psilocybin;
  • Over 20 patent applications to-date, including three international Patent Cooperation Treaty (PCT) applications covering extraction, standardization, purification and delivery of botanical drug candidates;
  • Completed industry-first export of current good manufacturing practices (“cGMP”)-quality natural psychedelic substances to the United States;
  • Psilo Scientific Ltd., Filament’s wholly-owned subsidiary received an amendment to Health Canada Dealer’s License for its facility, allowing the possession, production, and delivery of all controlled natural psychedelic substances;
  • Produced pharmaceutical-grade batches of natural psilocybin extracts including leading drug candidates which will be entered into upcoming FDA clinical trials.

Third Quarter and Post Period Financial and Capital Markets Highlights

  • Uplisted to the OTCQB Market under the symbol FLHLF on October 12, 2021;
  • Received Depository Trust Company (“DTC”) eligibility on October 12, 2021;
  • Listed on the Frankfurt Stock Exchange (“FSE”) under the symbol FSE:7QS on October 15, 2021;
  • Cash and cash equivalents of $6.4 million as of September 30, 2021.

Commentary and Outlook

“To-date, we have distinguished ourselves as a leader in the extraction and drug development of all-natural psychedelic compounds through our patent-protected botanical extraction process and recent FDA approval of the first-ever clinical trial using all-natural psychedelics to treat a variety of mental health disorders,” said Benjamin Lightburn, Chief Executive Officer. “Our team continues to quickly execute on Filament’s operational milestones, supported by our industry partnerships, extraction expertise and long-term IP strategy. Our goal is to continue our momentum by advancing our novel psilocybin and psilocin compounds through clinical trials, further building out our IP protection, and establishing ourselves as a unique provider of all-natural pharmaceutical-grade psychedelics to the industry. We are committed to maintaining this pace of innovation in order to support the treatment of mental health conditions with safe, natural psychedelics as soon as possible.”

 

ABOUT FILAMENT HEALTH (OTCQB:FLHLF) (NEO:FH) (FSE:7QS)

Filament Health is a clinical-stage natural psychedelic drug development company. We believe that safe, standardized, naturally-derived psychedelic medicines can improve the lives of many, and our mission is to see them in the hands of everyone who needs them as soon as possible. Filament’s platform of proprietary technology platform enables the discovery, development, and delivery of natural psychedelic medicines for clinical development. We are paving the way with the first-ever natural psychedelic drug candidates.

Learn more at www.filament.health and on Twitter, Instagram and LinkedIn.

 

MEDIA CONTACT

Anna Cordon, Director of Communications
778.245.9067
anna@filament.health

 

INVESTOR RELATIONS CONTACT

KCSA Strategic Communications
Tim Regan/Adam Holdsworth
347.487.6788
KCSA-investor-relations@filament.health

 

FORWARD LOOKING INFORMATION

Certain statements and information contained herein may constitute “forward-looking statements” and “forward-looking information,” respectively, under Canadian securities legislation. Generally, forward-looking information can be identified by the use of forward-looking terminology such as, “expect”, “anticipate”, “continue”, “estimate”, “may”, “will”, “should”, “believe”, “intends”, “forecast”, “plans”, “guidance” and similar expressions are intended to identify forward-looking statements or information. The forward-looking statements are not historical facts, but reflect the current expectations of management of Filament regarding future results or events and are based on information currently available to them. Certain material factors and assumptions were applied in providing these forward-looking statements. The forward-looking statements discussed in this press release may include, but are not limited to, information concerning Filament’s upcoming clinical trials; strategic and growth plans of the Company including intellectual property; and the impact, timing and accessibility of psychedelic treatments. Forward-looking statements regarding the Company are based on the Company’s estimates and are subject to known and unknown risks, uncertainties and other factors that may cause the actual results, levels of activity, performance or achievements of Filament to be materially different from those expressed or implied by such forward-looking statements or forward-looking information, including capital expenditures and other costs. There can be no assurance that such statements will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements. Accordingly, readers should not place undue reliance on forward-looking statements and forward-looking information. Filament will not update any forward-looking statements or forward-looking information that are incorporated by reference herein, except as required by applicable securities laws.15

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Red Light Holland Psilocybin Truffles, Sold in The Netherlands, Complete First Evaluation Under a Health Canada Approved cGMP Laboratory

Red Light Holland Psilocybin Truffles, Sold in The Netherlands, Complete First Evaluation Under a Health Canada Approved cGMP Laboratory

  • Red Light Holland is continuing its groundbreaking working synergies with Shaman Pharma Corp. and their cGMP laboratory partner, CCrest Laboratories Inc. who holds a Controlled Drugs and Substances License issued by Health Canada

  • Red Light Holland previously completed two exports, under Health Canada psilocybin import permits, for commercial sale of psilocybe truffles grown in the Company’s farm in Horst, Netherlands to CCrest Laboratories’ cGMP pharmaceutical laboratory in Montreal, Canada

  • Red Light Holland’s psilocybe truffles are being evaluated and tested by CCrest Laboratories for:
    • The suitability of Red Light Holland’s naturally occuring psilocybin as a source of active pharmaceutical ingredients (“API”) for scientific and potentially medical and therapeutic purposes
    • Providing Red Light Holland customers with scientific information regarding relative strength of different truffles strain sold
    • Moving towards dose standardization in anticipation of Oregon measure 109 and potentially other world wide locations.

  • Red Light Holland and CCrest Laboratories continue to demonstrate their strong commitment to the highest regulatory compliance standards

Toronto, Ontario–(Newsfile Corp. – November 15, 2021) – Red Light Holland Corp. (CSE: TRIP) (FSE: 4YX) (OTC Pink: TRUFF) (“Red Light Holland” or the “Company“), an Ontario-based corporation engaged in the production, growth and sale of a premium brand of magic truffles, is pleased to announce that it has received the first reports, produced by Shaman Pharma Corp. and CCrest Laboratories Inc. under Health Canada approval, evaluating the suitability of Red Light Holland’s natural psilocybin as a source of active pharmaceutical ingredients (“API”) for scientific and potentially medical and therapeutic purposes.

“This report is a step forward both for the recreational market, as well as the pharmaceutical market interested in naturally occurring psilocybin. We’re excited to share some of the scientific findings from the report on the three different truffles strains that we grow in The Netherlands, for our newly launched variety of products such as the iMicrodose Triniti pack, featuring all three strains that were tested,” said Todd Shapiro, CEO and Director of Red Light Holland. “Red Light Holland and Shaman Pharma are once again pushing the limits, having a true ally and partner with cutting-edge scientific expertise to evaluate our truffles. This is certainly a major milestone in Red Light Holland’s mandate of pursuing research and development, product advancements, technology and applied science which bolsters our Scarlette Lillie Science and Innovation division.”

Red Light Holland initially supplied its truffles in March 2021, with a second shipment in August 2021, to CCrest Laboratories, a cGMP pharmaceutical laboratory in Montreal enabled with a Health Canada Controlled Drugs and Substances license, specializing in highly regulated narcotics, including psychedelics. The raw materials proved to be suitable to complete the first phase of the scientific research, which included the development of proprietary analytical methods and protocols, such as assays to determine the presence and concentration of psilocybin and performing extraction to isolate psilocybin, from both fresh and dried sclerotia.

These cGMP compliant scientific methods and protocols of Quality Control, Analysis and Extraction are aimed at developing intellectual property for achieving the industrial-scale commercialization of medical purpose psychedelic substances in this emerging pharmaceutical sector. Exceeding the exacting regulatory requirements opens a new realm of possibilities for disruptive healthcare innovation using natural psychedelic mushroom derivatives.

Given the prohibited status of psilocybin, listed along Schedule I drugs under the United Nations 1971 Convention on Psychotropic Substances, science on the subject has remained limited, mostly manifested in the literature and methods produced in academic settings. Some of the known compounds in magic mushrooms – psilocybin, psilocin, norpsilocin, baeocystin, norbaeocystin, and aeruginascin – present similarities in their molecular structure, yet these chemicals can react with significant variation in the laboratory, and their little-known differences in behavior once inside the body could prove complimentary or synergistic, possibly creating a so-called entourage effect.

The report demonstrates that different solvents, such as water and methanol in various ratios, render extraction at different speed and quantity and can transform the compounds in the process. Using the same materials with various process modifications, the individual effect on an organism (e.g., human) could yield a significant difference in cognitive experience. In human metabolism, psilocybin is primarily a pro-drug that is dephosphorylated to active metabolite psilocin. One variation in the extraction method has yielded exclusively psilocin, indicating it could bypass dephosphorylation in the metabolism. These variations can lead to discovering innovative delivery mechanisms, which could provide better control between the onset speed and effective duration.

As one of the involved scientists explains, they have positively answered the hypothesis “what if?…” Red Light’s truffles are a viable source of active compounds, the next objective is using the compounds in the development process of pharma-grade ingredients or creating standardised doses for legal markets. With the first phase considered a success, the companies are wrapping up this work and moving to the next phases.

The scientists are now focusing on optimizing the extraction yield, as well as generating comparative data between the raw material attributes: genetic, size and weight, water content, and so on, as factors that can establish the proportions and total content of the various compounds, in a newly developed proprietary protocol identified as SP1-173-L – Qualitative and Quantitative Determination of Psilocybin & Psilocin truffles and mushrooms by Liquid Chromatography.

The objective of the SP1-173-L protocol is to assess the content of compounds in three species of truffles: Galindoi, Mexicana & Tampanensis, using the Liquid Chromatography method developed at CCrest Laboratories. The study will address the suitability of the analytical procedure, the assay of compounds in the three varieties of truffles and the variability of contents within the species and truffles size. Water content will be determined for all specified and sized samples. The tests will be performed by trained analysts at CCrest Laboratories, ensuring that the facilities and instrumentation are properly calibrated and qualified as needed. The laboratory systems will be in compliance with applicable regulations and in-house general laboratory procedures.

This protocol defines the experimental design and the data to be collected for the comparison of compounds contained in truffles of different size and species. The assay is conducted on three species of truffles, supplied by Red Light Farm. The data evaluation consists of:

  • Evaluation of the suitability of the analytical procedure SP1-173-L (precision and repeatability of injection).
  • The comparison of content of compounds will be obtained from three different samples from each species: small truffles, big truffles and a mix of small and big truffles, for a total of nine samples.
  • Determination of water content in the three different species of fresh truffles: Galindoi, Mexicana and Tampanensis.

In previous assays detailed in the reports, the Mexicana species appeared to be the most potent by a few percentage points, measuring at just under 1mg/gram of combined psilocybin and psilocin. The Tampanensis showed the highest proportion of psilocybin, the psilocin composing less than 10% of the total. The Galindoi, while the least potent overall, demonstrated the most balanced mix, with the psilocin equal to slightly more than 50% of the psilocybin content. While these three species are currently sold legally in the Netherlands, due to regulatory restrictions it has not been possible before now to achieve this level of comparison in a formal cGMP setting.

“We are advancing in uncharted territory where we are discovering a promising horizon, so we are definitely motivated to keep moving forward. This scientific work barely scratches the surface of possibilities, we are excited to increasingly deploy our proven pharma abilities in deepening the qualification of Red Light Holland`s truffles as a source of novel therapeutic ingredients,” commented Alex Grenier, CEO of Shaman Pharma and President of CCrest Laboratories. “While synthetic psychedelics are dominating the field, it makes sense to look at the original natural source, because something like an entourage effect would not be reproduced by synthesis. Just as much-hyped artificial cannabinoid analogues were not successful in displacing phytocannabinoids (marijuana), we anticipate the development of a tremendous share of demand for natural psychedelic mushroom derivatives, initially to supply research before cascading downstream to larger markets. Our approach, which is scientific, rigorous, and calculated, is also tailored to the real-world movement out there, the active audience for psychedelics, including many scientists, who are demanding natural origins.”

Red Light Holland continues to establish itself as a leader in the recreational sector and push for legal, responsible and safe access to natural psychedelic truffles/mushrooms while Scarlette Lillie Science and Innovation pursues research and development, technology, and applied science.

About Red Light Holland

Red Light Holland is an Ontario-based corporation engaged in the production, growth and sale (through existing Smart Shops operators and an advanced e-commerce platform) of a premium brand of magic truffles.

For additional information on the Company:
Todd Shapiro
Chief Executive Officer & Director
Tel: 647-643-TRIP (8747)
Email: todd@redlighttruffles.com
Website: https://redlighttruffles.com/

Forward-Looking Statements

About Shaman Pharma Corp.

Shaman Pharma is a federally registered Canadian corporation with the mission to power outstanding psychedelic life science innovation. Accelerating time-to-market through its portfolio of assets, Shaman launches and consolidates revenue-driven pharma-biotech life sciences ventures focused on supplying psychedelic drugs & novel active ingredients.

Forward-Looking Statements

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.

Certain information set forth in this news release may contain forward-looking statements that involve substantial known and unknown risks and uncertainties, certain of which are beyond the control of Red Light Holland. Forward-looking statements are frequently characterized by words such as “plan”, “continue”, “expect”, “project”, “intend”, “believe”, “anticipate”, “estimate”, “may”, “will”, “potential”, “proposed” and other similar words, or statements that certain events or conditions “may” or “will” occur. These statements are only predictions. Readers are cautioned that the assumptions used in the preparation of such information, although considered reasonable at the time of preparation, may prove to be imprecise and, as such, undue reliance should not be placed on forward-looking statements. Forward looking statements include, but are not limited to: statements with respect to the evaluation and testing of the Company’s naturally occurring psilocybe truffles by CCrest Laboratories for scientific and medical purposes; the potential of the Company’s products being used for scientific and medical purposes; statements with respect to the Company’s expansion into the mental wellness pharmaceutical sector; the future sharing of the test results with the Company’s customers and shareholders; and the Company’s ability to establish itself as the leader in the recreational psychedelics sector.

Forward-looking information is based on a number of key expectations and assumptions made by Red Light Holland, including without limitation: the COVID-19 pandemic impact on the Canadian economy and Red Light Holland’s business, and the extent and duration of such impact; no change to laws or regulations that negatively affect Red Light Holland’s business; there will be a demand for Red Light Holland’s products in the future; no unanticipated expenses or costs arise; the Company will be able to continue to develop products that are allowed to be imported and sold under Health Canada’s import permit; and the partnership with Shaman Pharma Corp. will help Red Light Holland to achieve its business goals. Although the forward-looking information contained in this news release is based upon what the Company believes to be reasonable assumptions, it cannot assure investors that actual results will be consistent with such information.

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 inability of the Company to continue as a going concern; the inability of the Company to obtain all necessary governmental and/or other regulatory approvals, licenses, and permits necessary to operate and expand the Company’s facilities; the effect of regulatory and/or political change and its effect on the legislation and regulations surrounding the psychedelics industry; p negative perception of the medical-use and adult-use psilocybin industry; the inability of CCrest to complete the planned testing of the Company’s products; the potential unviability of psilocybin for medical and/or scientific purposes; the inability of the Company to continue its growth; the Company’s limited operating history; reliance on management; the Company’s requirements for additional financing; and competition for mental health and wellness investments.

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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Novamind to Present at International Summit on Psychedelic Therapies for Mental Illness

Novamind to Present at International Summit on Psychedelic Therapies for Mental Illness

TORONTO, ON / November 15, 2021 / Novamind Inc. (CSE: NM | OTCQB: NVMDF | FSE: HN2) (“Novamind” or the “Company”), a leading mental health company specialized in psychedelic medicine, will participate in Mind Medicine Australia’s International Summit on Psychedelic Therapies for Mental Illness. Novamind’s Chief Medical Officer, Dr. Reid Robison, will present a virtual keynote on the use of psychedelic medicine to treat eating disorders on November 18 at 7:30 PM (EST).

For more information about the event, visit https://summit.mindmedicineaustralia.org/

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

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

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

Bill Mitoulas, Investor Relations
Email: bill@novamind.ca

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

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MindMed Announces Financial Results for the Third Quarter 2021 and Business Highlights; Cash Balance of $145.9 USD ($185.4 CAD) to Execute on Diverse Clinical Pipeline

MindMed Announces Financial Results for the Third Quarter 2021 and Business Highlights; Cash Balance of $145.9 USD ($185.4 CAD) to Execute on Diverse Clinical Pipeline

MindMed (Nasdaq: MNMD, NEO: MMED, DE: MMQ), a leading biotech company developing psychedelic-inspired therapies, has announced its quarterly financial results for the quarter ended September 30, 2021.

Third Quarter 2021 Financial Highlights (in USD)

  • Cash Balance. Total assets as of September 30, 2021 were $178.6 million, including $145.9 million in cash, as compared to $85.6 million, including $80.1 million in cash, as of December 31, 2020
  • Net Cash Used in Operating Activities. Net Cash Used in Operating Activities of $10.8 million and $31.9 million for the three and nine months ended September 30, 2021, as compared to $5.8 million and $16.5 million for the three and nine months ended September 30, 2020, respectively
  • Net Loss. Net and comprehensive loss of $24.3 million and $74.6 million for the three and nine months ended September 30, 2021, as compared to $8.6 million and $21.4 million for the three and nine months ended September 30, 2020

Third Quarter 2021 Business Highlights

  • Announced the Appointment of Andreas Krebs and Carol Vallone as Board Directors and the Transition of Bruce Linton
  • Appointed three new members to its Scientific Advisory Board: Dr. Maria Oquendo, Ruth Meltzer Professor and Chairman of Psychiatry at University of Pennsylvania and Psychiatrist-in-Chief at the Hospital of the University of Pennsylvania; Dr. Bob Dworkin, Professor of Anesthesiology and Perioperative Medicine, Neurology, and Psychiatry, and Professor in the Center for Health + Technology, at the University of Rochester School of Medicine and Dentistry; and Dr. Bryan Roth, University of North Carolina Psychiatrist and Pharmacologist
  • MindMed and Liechti Lab Provided Results from the Psilocybin Research and Development (R&D) Collaboration
  • Joined the Clinical Trials Transformation Initiative and Critical Path Institute’s Patient-Reported Outcome Consortium
  • Announced a Strategic Research Collaboration with Sphere Health
  • MindMed and BioXcel Therapeutics Published an International Patent Application Describing a System for Identifying Agitation Episodes
  • Announced Collaboration with Forian to Advance Development of Personalized Psychiatry for Anxiety Disorders

Management Update & Earnings Call

Management will host an earnings call to review the third quarter financials and business developments on Wednesday, November 17th, 2021, at 8:00 am EST. Details are below:

https://mindmed-co.zoom.us/webinar/register/WN_Tp–QUSPS9u17HCQwxlc4Q

Complete financial statements along with related management’s discussion and analysis can be found in the System for Electronic Document Analysis and Retrieval (SEDAR), the electronic filing system for the disclosure documents of issuers across Canada at www.SEDAR.com and on the Electronic Data Gathering, Analysis, and Retrieval system (EDGAR), the electronic filing system for the disclosure of documents of issuers in the United States at www.sec.gov.

About MindMed

MindMed is a clinical-stage biotech company that discovers, develops, and deploys psychedelic inspired medicines and therapies to address addiction and mental illness. The company is assembling a compelling drug development pipeline of innovative treatments based on psychedelic substances including psilocybin, LSD, MDMA, DMT and an ibogaine derivative, 18-MC. The MindMed executive team brings extensive biopharmaceutical experience to MindMed’s approach to developing the next generation of psychedelic inspired medicines and therapies.

MindMed trades on the NASDAQ under the symbol MNMD and on the Canadian NEO Exchange under the symbol MMED. MindMed is also traded in Germany under the symbol MMQ. For more information: www.mindmed.co

Forward-Looking Statements

Certain statements in this news release related to the Company constitute “forward-looking information” within the meaning of applicable securities laws and are prospective in nature. Forward-looking information is not based on historical facts, but rather on current expectations and projections about future events and are therefore subject to risks and uncertainties which could cause actual results to differ materially from the future results expressed or implied by the forward-looking statements. These statements generally can be identified by the use of forward-looking words such as “will”, “may”, “should”, “could”, “intend”, “estimate”, “plan”, “anticipate”, “expect”, “believe”, “potential” or “continue”, or the negative thereof or similar variations. Forward-looking information in this news release include, but are not limited to, statements regarding the start of MindMed’s Phase 1 clinical trial of dimethyltryptamine (DMT), the business and the therapeutic potential of MindMed’s product candidates, the ability to successfully execute and delivery on the R(-)-MDMA Program, the ability to achieve success with our collaborations with Sphere Health and Forian, the successful outcome of the Phase 1 clinical trial of DMT, the ability to initiate a Phase 2 clinical trial of DMT, regulatory approvals, the effects of DMT, subject enrollment and the administration method of DMT. Although the Company believes that the expectations reflected in such forward-looking information are reasonable, such information involves risks and uncertainties, and undue reliance should not be placed on such information, as unknown or unpredictable factors could have material adverse effects on future results, performance or achievements of the Company. There are numerous risks and uncertainties that could cause actual results and the Company’s plans and objectives to differ materially from those expressed in the forward-looking information, including history of negative cash flows; limited operating history; incurrence of future losses; availability of additional capital; lack of product revenue; compliance with laws and regulations; difficulty associated with research and development; risks associated with clinical trials or studies; heightened regulatory scrutiny; early stage product development; clinical trial risks; regulatory approval processes; novelty of the psychedelic inspired medicines industry; as well as those risk factors discussed or referred to herein and the risks described under the headings “Risk Factors” in the Company’s filings with the securities regulatory authorities in all provinces and territories of Canada which are available under the Company’s profile on SEDAR at www.sedar.com and with the U.S. Securities and Exchange Commission on EDGAR at www.sec.gov. Should one or more of these risks or uncertainties materialize, or should assumptions underlying the forward-looking information prove incorrect, actual results and future events could differ materially from those anticipated in such information. Although the Company has attempted to identify important risks, uncertainties and factors that could cause actual results to differ materially, there may be others that cause results not to be as anticipated, estimated or intended. These and all subsequent written and oral forward-looking information are based on estimates and opinions of management on the dates they are made and are expressly qualified in their entirety by this notice. Except as required by law, the Company does not intend and does not assume any obligation to update this forward-looking information.

Media Contact: mindmed@150bond.com

Posted on

Cybin Inc. Reports its Second Quarter Financial Results and Recent Business Highlights

Cybin Inc. Reports its Second Quarter Financial Results and Recent Business Highlights

– Company to host conference call at 4:30pm EST today –

TORONTO–(BUSINESS WIRE)– Cybin Inc. (NEO:CYBN) (NYSE American:CYBN) (“Cybin” or the “Company”), a biopharmaceutical company focused on progressing “Psychedelics to TherapeuticsTM”, today reported unaudited financial results for its second quarter ended September 30, 2021.

“The first half of the year has been a transformative period for Cybin that included significant and swift advancements in our research and development pipeline and overall business. Through CYB003, we believe that we have identified a potentially safer treatment option for patients with depression and addiction disorders that we expect to have strong intellectual property protection and a positive pharmacokinetic profile for patients, providers and payers. We plan to move through the ongoing, remaining preclinical studies quickly and submit an investigational new drug application and clinical trial application in the second quarter of 20221, in the U.S. and the U.K., respectively,” said Doug Drysdale, Chief Executive Officer of Cybin.

Drysdale continued, “In addition, we continue to evolve our value-driving, patient-centered approach to potential treatments for mental health and addiction through our commitment to advancing programs such as EMBARK, that aims to facilitate psilocybin-assisted psychotherapy for frontline workers impacted by the COVID-19 pandemic, as well as targeted research using the Kernel Flow neuroimaging technology that we expect will allow us to quantitively understand the psychedelic experience in the brain as it is happening. We believe these programs combined with our proprietary psychedelic new chemical entities have the potential to transform the treatment landscape for various psychiatric and neurological conditions.”

Recent Business and Pipeline Highlights:

  • Announced preclinical data for its novel deuterated psilocybin analog, CYB003, for the potential treatment of major depressive disorder and alcohol use disorder. The data demonstrated that CYB003 may provide significant treatment benefits to address the challenges and limitations of oral psilocybin, including improved safety through less patient variability, reduced clinic times through faster onset of action and shorter duration of effect, and lower dosing through improved brain penetration, which may result in fewer side effects, ultimately offering an improved patient experience. Cybin expects to complete the ongoing preclinical studies of CYB003 in Q1 2022 and submit an investigational new drug application (“IND”) to the U.S. Food and Drug Administration (the “FDA”), and a clinical trial application with the U.K. Medicines and Healthcare Products Regulatory Agency in Q2 20222.
  • Granted a Schedule I manufacturing license from the U.S. Drug Enforcement Agency for the Company’s Boston-area research lab that is expected to allow the Company to expand its internal research and development capabilities.
  • Received approval from the FDA for its IND application to proceed with a Company-sponsored feasibility study using the Kernel Flow quantitative neuroimaging technology to measure ketamine’s psychedelic effect on cerebral cortex hemodynamics.
  • Launched the EMBARK Psychedelic Facilitator Training Program in collaboration with the University of Washington in preparation for the first clinical trial of psilocybin-assisted psychotherapy to address COVID-19 related distress in frontline healthcare professionals.
  • Welcomed Dr. Amir Inamdar as Chief Medical Officer for European Operations; Dr. Geoff Varty as Head of Research and Development; and Leah Gibson as Vice President of Investor Relations.

Second-Quarter Financial Highlights

  • Cash and cash equivalents totaled to C$75.2 million as of September 30, 2021.
  • Net loss was C$17.6 million for the quarter ended September 30, 2021 of which non-cash expenses totaled C$6.0 million and cash-based operating expenses totaled C$11.6 million.

Conference Call and Webcast Details

DATE:

Monday, November 15, 2021

TIME:

4:30 p.m. (EST)

DIAL-IN

1-844-200-6205 (U.S. toll free) or 1-833-950-0062 (Canada toll free)

CODE

727873

WEBCAST

https://events.q4inc.com/attendee/747515026

The live and archived webcast will also be available on the Company’s Investor Relations site under the Events & Presentations page.

Business Update

Cybin has decided not to proceed with its nutraceutical product line in order to focus its efforts on the research and development of its psychedelic molecules. Further, the Company no longer anticipates conducting business activities in Jamaica, as the Company focuses on the new Deuterated Psilocybin Analog Program. The Company intends to complete future clinical trials in the U.S. and the U.K.

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 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.

Cautionary Notes and Forward-Looking Statements

Certain statements in this news release related to the Company are forward-looking statements and are prospective in nature. Forward-looking statements are not based on historical facts, but rather on current expectations and projections about future events and are therefore subject to risks and uncertainties which could cause actual results to differ materially from the future results expressed or implied by the forward-looking statements. These statements generally can be identified by the use of forward-looking words such as “may”, “should”, “could”, “intend”, “estimate”, “plan”, “anticipate”, “expect”, “believe” or “continue”, or the negative thereof or similar variations. Forward-looking statements in this news release include statements regarding the Company’s development of innovative drug delivery systems, statements regarding the potential benefits of the Company’s novel deuterated psilocybin analog, CYB003, statements regarding the Company’s completion of preclinical studies of CYB003 in Q1 20223 and the submission of a new drug application and clinical trial application in Q2 20224, statements regarding the Company’s EMBARK Psychedelic Facilitator Training Program, statements regarding the anticipated results of using Kernel Flow technology in the Company’s research, and statements regarding the expansions of the Company’s internal research and development capabilities under its Schedule I manufacturing license.

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 each of the Company’s management’s discussion and analysis for the three and six month periods ended September 30, 2021, the Company’s annua l information form for the year ended March 31, 2021, and the Company’s listing statement dated November 9, 2020, which are available under the Company’s profile on www.sedar.com and with the U.S. Securities and Exchange Commission on EDGAR at www.sec.gov. Although the forward- looking statements contained in this news release are based upon what management of the Company believes, or believed at the time, to be reasonable assumptions, the Company cannot assure shareholders that actual results will be consistent with such forward-looking statements, as there may be other factors that cause results not to be as anticipated, estimated or intended. Readers should not place undue reliance on the forward-looking statements and information contained in this news release. The Company assumes no obligation to update the forward- looking statements of beliefs, opinions, projections, or other factors, should they change, except as required by law.

Cybin makes no medical, treatment or health benefit claims about Cybin’s proposed products. The U.S. Food and Drug Administration, Health Canada or other similar regulatory authorities have not evaluated claims regarding psilocybin, psychedelic tryptamine, tryptamine derivatives or other psychedelic compounds. The efficacy of such products has not been confirmed by approved research. There is no assurance that the use of psilocybin, psychedelic tryptamine, tryptamine derivatives or other psychedelic compounds or can diagnose, treat, cure or prevent any disease or condition. Vigorous 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 Based on a calendar year-end.

2 Based on a calendar year-end.

3 Based on a calendar year-end.

4 Based on a calendar year-end.

 

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

Source: Cybin Inc.