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Algernon Pharmaceuticals Hits Co-Primary Endpoint in its Phase 2 Study of Ifenprodil for Idiopathic Pulmonary Fibrosis and Chronic Cough

Algernon Pharmaceuticals Hits Co-Primary Endpoint in its Phase 2 Study of Ifenprodil for Idiopathic Pulmonary Fibrosis and Chronic Cough

VANCOUVER, British Columbia, July 18, 2022 (GLOBE NEWSWIRE) — Algernon Pharmaceuticals Inc. (the “Company” or “Algernon”) (CSE: AGN) (FRANKFURT: AGW0) (OTCQB: AGNPF) a clinical stage Canadian pharmaceutical development company, is pleased to announce positive topline data showing that it has met the co-primary endpoint in its Phase 2 proof of concept study evaluating NP-120 (“Ifenprodil”) for the potential treatment of idiopathic pulmonary fibrosis (“IPF”) and chronic cough. In the study, 65% of patients had stable or improved forced vital capacity (“FVC”) over the 12-week treatment period with statistical significance when compared to an anticipated placebo effect of 40%. FVC is the amount of air that can be forcibly exhaled from one’s lungs after taking the deepest breath possible.

Ifenprodil is an N-methyl-D-aspartate (NMDA) receptor antagonist specifically targeting the NMDA-type subunit 2B (GluN2B), which prevents glutamate signalling. Ifenprodil represents a novel first in class treatment for both IPF and chronic cough.

IPF Data Set

To understand the potential efficacy for Ifenprodil in IPF patients, lung function in this trial was measured by FVC (a best-efforts measurement) which was taken for each patient at baseline, and then again at 12 weeks. Patients whose FVC declined were classified as non-responders, while those whose FVC improved or remained stable were classified as responders. The primary endpoint of the IPF part of the study was the proportion of patients who responded.

Of the 20 patients who enrolled, 13 (65%) had stable or improved FVC over the 12-week treatment period with statistical significance when compared to an anticipated placebo effect of 40% (p=.0225, 95% CI 40.8 to 84.6%, all numbers are Intent-to-Treat analysis). Importantly, key opinion leaders advising the company, as well as historical data on previously conducted IPF clinical studies(1), indicated that approximately 30-40% of IPF patients would experience no decline in FVC if they were dosed with a placebo over the 12-week period, demonstrating that Ifenprodil showed promising initial IPF efficacy in this trial.

The Company also reports trends to reduction in many of the serum markers that were tested including proC3, C3M, C6M, reC1M, proC8 and ELP-3, although the data did not reach statistical significance. Elevation of these markers has been associated with increased mortality and risk of disease progression in previous research studies.

“The IPF data looks quite good,” said Dr. Martin Kolb, professor of respirology at McMaster University and global expert on IPF. “I was very surprised to see the data achieve statistical significance with such a small study size, when you consider the original goal of the study was to try to identify a signal. As a result, I am confident that the Company should begin planning a sufficiently powered Phase 2b study to investigate Ifenprodil as a possible new treatment for IPF patients, including those who have associated cough.”

Chronic Cough Data Set

For the chronic cough part of the study’s primary endpoint, 30% of subjects achieved the endpoint of a 50% reduction in the average number of coughs per hour over 24 hours from baseline to week 12. While this primary cough study endpoint did not achieve statistical significance when compared to an anticipated placebo effect of 25%, the secondary endpoint of actual changes (reduction) in cough counts did. Specifically, subjects experienced a 24% relative reduction from baseline in mean cough count, and a 38% relative reduction from baseline in median cough count in their 24-hour cough count per hour at week 12 (p=0.0344). In addition, 75% of subjects saw improvements in their cough over 12 weeks.

This data shows that while Ifenprodil didn’t achieve the more stringent primary endpoint parameter on cough, there is a definite signal (effect) when comparing cough counts directly to their baseline measurement. Furthermore, in contrast with recent studies on cough drugs targeting purinergic receptors, the observed effect may not be dependent on a subject’s baseline cough count; in a subgroup analysis, subjects with baseline cough counts below the median for the study appeared to achieve similar reductions in relative cough count to those with baseline counts above the median.

“These data are quite compelling,” said Dr. Jacky Smith, Professor of Respiratory Medicine at the University of Manchester, and an Honorary Consultant at Manchester University NHS Foundation Trust. “Although the primary cough endpoint does not reach statistical significance, the reductions in cough counts, particularly the median cough counts, are suggestive of a beneficial effect. Furthermore, the choice of a 25% response rate as a comparator may understate the benefit. Existing IPF therapies have little to no effect on cough, and so coupled with the results in IPF seen in this trial, there is great reason for optimism. I am working with the Company to further analyze the data and encourage them to continue to study the effects on cough as development of this drug continues.”

Safety Data

The results also show that Ifenprodil’s safety profile in this trial was consistent with findings from previous studies of the drug, with no new safety signals observed. 45% of subjects experienced at least one treatment-emergent adverse events (TEAE), most of which were mild in intensity. The most common TEAE’s were gastrointestinal disorders (25%) and decreased appetite (10%). One participant withdrew from the study due to a hepatic neuroendocrine tumour unrelated to Ifenprodil, that resulted in death. Although Ifenprodil has been used in Japan for decades to treat vertigo, this is the first study in an IPF population, and so the Company is pleased to report that no new safety concerns were identified.

Full Data Set

The Company expects to receive the full data set from the study in August 2022 and will present the full results of the study at the 21st International Colloquium on Lung and Airway Fibrosis in Reykjavik, Iceland in October 2022.

“Simply put, the IPF data is better than we could have imagined,” said Christopher J. Moreau, CEO of Algernon. “The outlook for patients with IPF remains dismal, with 50% mortality expected within 3-4 years and new drugs are desperately needed. Also, the IPF market size is projected to reach $4.2 billion by 2030(2), so it is a very commercially appealing indication to be advancing a new drug for. While the cough data is also promising, we will wait until we have the full data set before making any final decisions on pursuing both IPF and chronic cough in separate Phase 2b clinical studies, or focussing on just IPF patients with associated cough.”

U.S FDA pre-IND

Based on the positive data, the Company plans to file a pre-IND application with the U.S. FDA for a Phase 2b IPF study. The current plan would be to switch to a new once-a-day formulation of Ifenprodil from the 3-times daily dosing currently being used. The Phase 2b study will also have multiple arms, multiple doses, would be placebo controlled and would be double blinded and randomized.

For chronic cough, the Company has already filed a pre-IND application with the U.S. FDA and has announced that it has received positive feedback.

The Company will take additional time to review the full data set before a decision is made to pursue an independent Phase 2b study of chronic cough or to focus on Ifenprodil as a potential new IPF drug that also reduces cough for those patients that are suffering from both.

U.S Orphan Indication and Breakthrough Therapy

IPF is also classified as an orphan disease indication and as such, any new approved drugs are provided 7-year and 10-year market exclusivity in both the U.S and Europe, respectively. The Company plans to file for an orphan designation with the U.S FDA for Ifenprodil and IPF shortly.

The Company plans to file an application with the U.S. FDA for a Breakthrough Therapy designation as soon as possible.

Breakthrough Therapy designation is a process designed to expedite the development and review of drugs that are intended to treat a serious condition where preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over available therapy on a clinically significant endpoint(s).

Ifenprodil Patents

The Company also recently announced that it has been issued a patent from the Canadian Intellectual Property Office, No. 3101853, for the treatment of interstitial lung disease with Ifenprodil, entitled “Compositions and Methods for Treating Idiopathic Pulmonary Fibrosis.”

The invention claims treating interstitial lung disease, including IPF, with Ifenprodil. The base claims of the patent will be valid through 2040, excluding any patent term adjustments or extensions which may provide additional protection. The Company also has active patent applications for Ifenprodil for the same compositions and methods in the U.S., Europe, China and Japan.

About Ifenprodil

Ifenprodil is an N-methyl-D-aspartate (NMDA) receptor antagonist specifically targeting the NMDA-type subunit 2B (GluN2B). Ifenprodil prevents glutamate signalling. The NMDA receptor is found on many tissues including lung cells, T-cells, and neutrophils.

      https://erj.ersjournals.com/content/55/5/1902151(1)   
      https://www.astuteanalytica.com/industry-report/idiopathic-pulmonary-fibrosis-market(2)   

About Algernon Pharmaceuticals Inc. 

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

CONTACT INFORMATION

Christopher J. Moreau
CEO
Algernon Pharmaceuticals Inc.
604.398.4175 ext 701

info@algernonpharmaceuticals.com
investors@algernonpharmaceuticals.com
www.algernonpharmaceuticals.com

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

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

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Creso Pharma’s wholly-owned psychedelics subsidiary,
Halucenex Life Sciences Inc. making progress ahead of
its planned Phase II clinical trials

Creso Pharma’s wholly-owned psychedelics subsidiary, Halucenex Life Sciences Inc. making progress ahead of its planned Phase II clinical trials

Highlights:

  • Following strong inbound interest, Halucenex has made the strategic decision to broaden the scope of its planned phase II clinical trial and apply for a further amendment to its Clinical Trial Authorisation (“CTA”) from Health Canada
  • If granted, the updated CTA will allow Halucenex to include cohorts using Selective Serotonin Reuptake Inhibitors and not require patients to cease using prescribed medications a week prior to trial commencement
  • A broadened CTA would provide Halucenex with additional trial data, allow a larger spectrum of patients and valuable insight into how psilocybin interacts with other medications
  • Appointment of KGK Science Inc. (“KGK”) as contract research organisation provides additional expertise in a more cost effective manner KGK is a premium full service research organisation dedicated to providing clinical trial research that meets the highest quality standards
  • Doctor of medicine and neurologist Dr Gosia Eve Phillips, MD, DABPN appointed as Principal Investigator
  • Dr Phillips is an esteemed medical professional and has educational training from the University of Massachusetts Medical School, Columbia University and Harvard University
  • Final submissions to ethics review board made and are now pending ethics approval

Creso Pharma Limited (ASX:CPH, OTC:COPHF, FRA:1X8) (‘Creso Pharma’ or ‘the Company’) is pleased to advise that wholly-owned, Canadian based psychedelics company, Halucenex Life Sciences Inc. (“Halucenex”) has executed on a number of milestones making progress ahead of its planned phase II clinical trials to test the efficacy of psilocybin on treatment resistant Post Traumatic Stress Disorder (PTSD).

Application for amendments to Clinical Trial Authorisation (“CTA”) from Health Canada:
Following a material number of enquiries from potential trial participants, Halucenex has made the strategic decision to apply for amendments to its currently approved CTA (refer ASX announcement: 28 February 2022) to include cohorts that are currently utilising Selective Serotonin Reuptake Inhibitors (SSRIs) and not require potential patients to stop using prescribed medications for a week prior to the potential Phase II trials’ commencement. The decision comes following ongoing engagement with potential patients, veterans affairs groups and the general public and will broaden the scope of the planned clinical trials. It will also provide Halucenex with additional data on how psilocybin interacts when used in combination with other medication commonly used by PTSD sufferers.

The Company anticipates that the receipt of an amended CTA should occur shortly, and subject to ethics approval, this will allow Halucenex to complete patient recruitment initiatives and begin administering first dosages.

Appointment of KGK Science Inc. as contract research organisation:
Following an ongoing review of service providers, Halucenex has also engaged leading research organisation, KGK Science Inc. (“KGK”)to assist with clinical trial initiatives. As a premium full-service contract research organisation, KGK is dedicated to providing clinical trial research that meets the highest quality standards. Led by a team of scientific research and regulatory experts, KGK combines cutting-edge clinical science with industry expertise to design clinical trials and claim substantiation strategies customised to meet the needs of clients. The Company has made the decision to appoint KGK following a review of clinical trial service providers. KGK will replace previously appointed investigator True North Clinical Research (refer ASX announcement: 17 March 2021), due to the group’s expertise in pharmaceuticals and natural health products and cost effectiveness.

Under its research services agreement with Halucenex, KGK will perform research services, including the development of the clinical trial protocol, preparations towards the Phase II clinical trials, data management and validation, statistical analysis and drafting of the final report (“Services”), for which the total set compensation payable to KGK by Halucenex will be CAD$339,440. The term of the Agreement will run until KGK has completed all services contemplated under the Agreement (“Expiry”), unless KGK terminates the Services at any time by providing Halucenex with 30 days of notice before the Expiry.

Dr Gosia Eve Phillips, MD, DABPN appointed as Principal Investigator:
Dr Phillips is a doctor of medicine and certified neurologist. She earned her Doctor of Medicine in 2001 and has also undertaken various educational practises through the University of Massachusetts Medical School, Columbia University and the Beth Israel Deaconess Medical Centre, Harvard University. Dr Phillips’ certifications include a licentiate of the Medical Council of Canada, a Diplomate, American Board of Psychiatry and Neurology, as well as a Diplomate, American Board of psychiatry and Neurology (subspecialty sleep medicine).

She has been recognised through the receipt of a number of awards including The Nickols Award, Department of Neurology, University of Massachusetts, The Practice-Based Learning Award, Department of Neurology, University of Massachusetts and The Professional Competency Award, Department of Neurology, University of Massachusetts.
As Principal Investigator, Dr Phillips will assist the Company as the physician leading the conduct of the clinical trial at the study site. Halucenex will leverage her extensive experience and background during additional trial preparation initiatives, throughout the trial and following to progress potential research or cooperative grants with government bodies and other large pharmaceutical companies. Final submissions made to Ethics Review Board: Halucenex has also successfully lodged its final submissions with the Ethics Review Board, on which an outcome is expected shortly. Ethics approval is a key component to the research process, which protects both patients and researchers during the initiative. The approval would be a major milestone for the Company and is expected to assist any future R&D initiatives undertaken by Halucenex in the ongoing use of psilocybin across various conditions.

Commentary:
Halucenex CEO and Founder Mr Bill Fleming said: “In the recent months, Halucenex has made considerable progress towards the commencement of what has the potential to be a ground-breaking research initiative. We have been completely inundated from several groups regarding potential participation in the study, highlighting the demand for an alternative treatment solution to pharmacological interventions. Further, by lodging an application to extend the scope of our CTA, we are expecting benefits from the additional data that the broadened scope will provide, including observing how psilocybin interacts with other medication being used as treatment for PTSD.

“We are confident that the appointment of both KGK and Dr Phillips will also be beneficial for the Company. KGK has extensive experience with pharmaceutical drug testing and development and provides a much more cost effective service offering. The appointment of someone as esteemed as Dr Phillips is also a great development for Halucenex. We look forward to working with both parties in the coming weeks.

“The Board and management will continue working with the independent ethics board and Health Canada for final approvals and expect additional updates to materialise shortly.”

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Red Light Holland and Mistercap LLC Partnership Update

Red Light Holland and Mistercap LLC Partnership Update

Clarification and additional information pertaining to the June 30th, 2022 Press Release regarding Red Light Holland and the MISTERCAP mushroom wellness brand.

Toronto, Ontario–(Newsfile Corp. – July 18, 2022) – 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 functional (e.g. shiitake, lion’s mane) mushroom home grow kits in North America, and a premium brand of magic truffles to the legal, recreational market within the Netherlands, is pleased to provide this clarification and update with additional information regarding its partnership with Mistercap LLC.

The partnership created by Red Light Holland and Mistercap LLC for the new Mushrooms wellness brand called MISTERCAP, will initially launch with a functional mushroom home grow kit, allowing customers to grow their own legal mushrooms in the comfort of their own homes, expected to be sold in Q4 of 2022. From there, the companies intend to expand to other legal, functional and innovative mushroom products, as well as a line of apparel and accessories, to be made available across the EU and North America in early 2023. Further, Mistercap LLC will be receiving marketing advisory services from the multi-platinum-selling, GRAMMY® and Golden Globe® Award-nominated recording artist Wiz Khalifa for the new MISTERCAP brand, who will leverage his social media presence to promote legal mushroom products.

The MISTERCAP brand, in conjunction with Red Light Holland, is also committed to creating educational and responsible use messaging in relation to the use of any products made available by the brand. Red Light Holland and Mistercap LLC will share further details on the MISTERCAP products, team, and vision in the weeks to come. MISTERCAP products will be intended to help promote a healthy lifestyle. No MISTERCAP products are intended to treat or cure any medical conditions and are in no event a substitute for professional medical care. No statements made by Red Light Holland, Mistercap LLC or Wiz Khalifa have been evaluated by the United States Food and Drug Administration or any other similar body of another jurisdiction, and are in no event a substitute for professional medical care. Red Light Holland, Mistercap LLC and Wiz Khalifa encourage all consumers to speak with their doctors and professional medical advisors for any solutions that may be appropriate for each person individually.

About MISTERCAP

MISTERCAP is a mushroom wellness brand founded in 2022 to create innovative functional mushroom wellness products and isaffiliated with multi-platinum-selling, GRAMMY® and Golden Globe® Award-nominated recording artist Wiz Khalifa, who provides marketing advisory services to the company. More information will be made available in the coming weeks on MISTERCAP.COM and INSTAGRAM.COM/MISTERCAP

Transaction Details

As has previously been disclosed, in connection with launching the MISTERCAP brand, Red Light Holland and Mistercap, LLC have entered into an intellectual property licensing agreement (the “IP Licensing Agreement“). Pursuant to the terms of the IP Licensing Agreement, Mistercap, LLC shall exclusively license certain intellectual property held by Mistercap, LLC to Red Light Holland to develop, cultivate, process, package, distribute and sell mushroom and/or truffle-related products under the MISTERCAP brands. The initial term of the IP Licensing Agreement shall be for three years and shall be automatically renewable for one-year successive terms upon Red Light Holland continuing to hit certain benchmark sales targets. As partial consideration for the license, Mistercap, LLC will be paid (i) C$250,000 in cash and (ii) C$1,000,000, which is to be satisfied through the issuance of common shares in the capital of Red Light Holland (the “Common Shares“) at a price of $0.075 per Common Share. The Common Shares will be subject to a four month and one day hold period pursuant to the polices of the Canadian Securities Exchange (“CSE“) and applicable securities laws. In addition, Mistercap, LLC will: (x) receive monthly royalty payments paid over the term of the IP Licensing Agreement, calculated based on the sale of products developed pursuant to the partnership and (y) be paid a monthly marketing fee. Additional payments are due in the event future markets are available to sell in pursuant to the terms of the IP Licensing Agreement. The Company has budgeted C$1,000,000 per year to fulfill royalty fees, marketing expenses and additional payment obligations owed to Mistercap, LLC pursuant to the terms of the IP Licensing Agreement. The Company plans on reallocating a majority of the $1,800,000 marketing budget outlined under the heading “Use of Proceeds and Milestones” in the Company’s management discussion and analysis for the nine months ended December 31, 2021 towards growing the MISTERCAP brand.

About Red Light Holland Corp.

The company is an Ontario-based corporation that specializes in the mushroom industry, and specifically home grow kits for functional natural mushrooms, while positioning itself to engage in the production, growth and sale (through existing Smart Shops operators and an advanced e-commerce platform) of a premium brand of magic truffles to the legal, recreational market within the Netherlands, in accordance with the highest standards, in compliance with all applicable laws.

For additional information:

Todd Shapiro
Chief Executive Officer and Director
Tel: 647-643-TRIP (8747)
Email: todd@redlight.co
Website: www.RedLight.co

Mistercap, LLC

The Lede Company / Chris Iacullo <Chris.Iacullo@ledecompany.com>
The Lede Company / Hannah Haines <Hannah. Haines@ledecompany.com>
The Lede Company / Sami Brensilber <Samantha.Brensilber@ledecompany.com>

Website: www.mistercap.com

Forward-Looking Statements

This press release contains certain “forward-looking information” within the meaning of applicable Canadian securities legislation. Such forward-looking information and forward-looking statements are not representative of historical facts or information or current condition, but instead represent only the Company’s beliefs regarding future events, plans or objectives, many of which, by their nature, are inherently uncertain and outside of the Company’s control. Often, but not always, forward-looking statements and information can be identified by the use of words such as “plans”, “expects” or “does not expect”, “is expected”, “estimates”, “intends”, “anticipates” or “does not anticipate”, or “believes”, or variations of such words and phrases or state that certain actions, events or results “may”, “could”, “would”, “might” or “will” be taken, occur or be achieved. Forward-looking information involves known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements of the Company or its respective subsidiaries to be materially different from any future results, performance or achievements expressed or implied by the forward-looking information contained in this news release. Examples of such information include statements with respect to: the plans and goals of the Company and MISTERCAP, including the launch of the MISTERCAP website and associated merchandise; the success of the MISTERCAP brand; future product offerings of the Company under the MISTERCAP brand; the timelines and markets associated with launching products under the MISTERCAP brand; the future marketing and advertising campaigns of the Company and MISTERCAP, including how the Company’s marketing budget will be utilized; additional payment obligations owing to MISTERCAP pursuant to the terms of the IP Licensing Agreement; the focus of the Company and MISTERCAP brand; the ongoing consideration payable under the IP Licensing Agreement; the renewability of the IP Licensing Agreement; and future changes in legislation and the regulations surrounding, among other things, the ability to sell the Company’s products in new markets.

Forward-looking information in this news release are based on certain assumptions and expected future events, namely: continued approval of the Company’s activities by the relevant governmental and/or regulatory authorities; the continued growth of the Company; the Company meeting their anticipated timeline and process for growth, sales, production and commercialization; the Company’s products being safe and providing their anticipated benefits; the Company and MISTERCAP fulfilling its future plans and goals, including the launch of the MISTERCAP website and associated merchandise; the MISTERCAP brand and future product offerings of the Company under the MISTERCAP brand succeeding; the Company launching products under the MISTERCAP brand upon the timelines and in the markets disclosed herein; the Company, MISTERCAP launching future marketing and advertising campaigns, including the Company’s marketing budget being utilized as outlined herein; additional payments being paid to MISTERCAP pursuant to the terms of the IP Licensing Agreement; the Company’s revenues will continue to grow; the Company and MISTERCAP fulfilling their respective obligations under the IP Licensing Agreement; the Company hitting certain benchmark sales under the IP Licensing Agreement; the term of the IP Licensing Agreement continuing to renew; additional jurisdictions permitting sales of the brand’s products in the future; and future changes in legislation and the regulations not impacting the Company’s ability to fulfil its plans and goals, including the ability to sell the Company’s products in new markets.

Risks, uncertainties and other factors involved with forward-looking information could cause actual events, results, performance, prospects and opportunities to differ materially from those expressed or implied by such forward-looking information, expectations regarding future growth, expansion, production, sales and commercialization of the operations of the business; regulatory and licensing risks; changes in general economic, business and political conditions, including changes in the financial and stock markets; risks related to infectious diseases, including the impacts of the COVID-19 pandemic; legal and regulatory risks inherent in the industry, including the global regulatory landscape and enforcement related to the brand’s products; political risks and risks relating to regulatory change; risks relating to anti-money laundering laws; compliance with extensive government regulation and the interpretation of various laws regulations and policies; public opinion and perception of the industry; risk that the Company’s products will be unsafe for personal consumption and/or not provide their anticipated benefits; risk that there may not be continued demand for the Company’s products and/or demand will plateau; risk that the Company and MISTERCAP may be unable to fulfill their future plans and goals, including the launch of the MISTERCAP website and associated merchandise; risk that the MISTERCAP brand and/or the product offered under the brand will be unsuccessful and will not sell; risk that the Company will be unable to offer product under the MISTERCAP brand; risks that the Company will be unable to meet the timelines and/or sell in the markets outlined herein associated with launching products under the MISTERCAP brand or at all; risks surrounding future marketing and advertising campaigns of the Company and MISTERCAP, including how the Company’s marketing budget will be utilized; risks around the quantum owing under the additional payment obligations owed to MISTERCAP pursuant to the terms of the IP Licensing Agreement; risk that the Company, alongside MISTERCAP, will be unable to increase revenues; risk that the Company and MISTERCAP will be unable to fulfill their respective obligations under the IP Licensing Agreement; risk that the Company will be unable to hit certain benchmark sales under the IP Licensing Agreement; risk that the term of the IP Licensing Agreement won’t be renewed following the initial term; risks surrounding additional jurisdictions not permitting sales of the brand’s products in the future; risk of future changes to regulations surrounding the brand’s products and/or to the Company’s business which may hinder the ability of the Company to attain its goals and/or pursue its plans and/or sell its products in additional markets; and such other risks contained in the public filings of the Company filed with Canadian securities regulators and available under the Company’s profile on SEDAR atwww.sedar.com.

Although the Company believes that the assumptions and factors used in preparing, and the expectations contained in, the forward-looking information and statements are reasonable, undue reliance should not be placed on such information and statements, and no assurance or guarantee can be given that such forward-looking information and statements will prove to be accurate, as actual results and future events could differ materially from those anticipated in such information and statements. The forward-looking information and forward-looking statements contained in this press release are made as of the date of this press release, and the Company does not undertake to update any forward-looking information and/or forward-looking statements that are contained or referenced herein, except in accordance with applicable securities laws.

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George Tziras to succeed Peter Rands as Small Pharma Chief Executive Officer

George Tziras to succeed Peter Rands as Small Pharma Chief Executive Officer

– Building on strong foundations to take Small Pharma through development to commercial success

– Peter Rands to take on role as Chief Innovation & Intellectual Property Officer

LONDON, July 18, 2022 (GLOBE NEWSWIRE) — Small Pharma Inc. (TSXV: DMT) (OTCQB: DMTTF) (the “Company” or “Small Pharma”), a biotechnology company focused on short-acting psychedelic-assisted therapies for mental health conditions, is pleased to announce that the Company’s board of directors (the “Board”) has appointed Mr. George Tziras as Chief Executive Officer of the Company (“CEO”), effective as of July 20, 2022. Mr. Peter Rands, founder and current CEO, will take on the role of Chief Innovation & Intellectual Property Officer of the Company (“CIIPO”). Mr. Rands will be relocating to the United States as part of a planned succession to better position the business for the later stages of clinical development and establishing the Company’s footprint in the United States. Mr. Rands will continue to serve on the Board following the transition.

Lyne Fortin, Chair of the Board, said: “With key data expected from our lead candidate, SPL026, and the anticipated launch of new clinical trials later this year, we have focused on building strength and breadth to our leadership team. George brings decades of international capital markets expertise and relationships, and critically he brings a sharp focus on corporate strategy to take the business forward at this pivotal stage of the Company’s growth. I would also like to take this opportunity to thank Peter. Small Pharma is the organization it is today due to his vision, entrepreneurship and ambition to find innovative therapeutic solutions for under-served mental health patients. With the recent addition of Dr. Alastair Riddell as COO, and Peter focused on innovation and intellectual property, we have a strong team to support George as he leads Small Pharma in building its reputation as a world leader in alternative treatments for mental health.”

Peter Rands, current CEO and future CIIPO of Small Pharma, added: “I am delighted to be handing the reins of the Company to my colleague, George. The best biotech companies must always have the right person at the top to take them through each stage of development. I am proud of what we have achieved in building the foundations of Small Pharma and now is the right time for George, with his deep understanding of markets, deal structure and business expertise to lead the Company into our critical next phase of evolution. For me, my new role is taking me back to where my heart is: innovation and the protection of it. I look forward enormously to supporting George in this job as we continue to shape the future of mental health treatment.”

George Tziras, current Chief Business Officer (“CBO”) and future CEO of Small Pharma, commented: “I am looking forward to taking on this role and the new challenges it will bring. Small Pharma is a great company with a bright future, which has the potential to deliver new alternative therapies that could change the lives of patients. Peter has done a brilliant job. I am excited to be leading the Company into the next stage of growth.”

Mr. Tziras initially joined Small Pharma in 2015 as a director of Small Pharma Ltd, the Company’s main operating subsidiary, before also being appointed to the role of CBO and director of the Company in 2021. George has been pivotal in building the Company’s reputation across the capital markets, leading to the successful fundraising of CDN$63 million in 2021, and its transformation from a private to a public company.  His role has been responsible for business development and strategy, investor relations and overseeing corporate activities.

Prior to joining Small Pharma full-time, George was an Executive Director at Goldman Sachs. George has over 15 years’ experience in investment banking and international capital markets, having worked at a number of global financial institutions including Credit Suisse, Nomura, Lehman Brothers and CIBC. Over the course of his career, he has executed a broad range of transactions including debt and equity financings; mergers, disposals and acquisitions; and private equity buyouts and debt restructurings, all across a number of industries, including healthcare.

Mr. Tziras holds a BA degree in Economics and Management from the University of Oxford and a MA degree in International Relations from the Johns Hopkins School of Advanced International Studies. 

Option Grant

In relation to Mr. Tziras’ appointment as CEO of Small Pharma, the Board has granted him options to purchase up to an aggregate of 1,000,000 common shares in the capital of the Company (the “Common Shares”) pursuant to the Company’s stock option plan. Each option is exercisable for one Common Share at a price equal to the greater of (i) $0.105 per Common Share; and (ii) the closing price of the Common Shares on July 18, 2022, being the first trading day after the release of the Company’s financial results. The options are exercisable for a period of ten years and are subject to certain vesting requirements.   

About Small Pharma

Small Pharma is a biotechnology company progressing a pipeline of short-acting psychedelics with therapy for the treatment of mental health conditions, with a current focus on depression. Small Pharma initiated a clinical program into N,N-dimethyltryptamine (“DMT”) assisted psychotherapy in February 2021. This program includes a Phase I/IIa trial on the Company’s lead candidate alongside the development of a 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 (< 30 mins), which allows for short treatment sessions and offers the potential for convenient supervised treatments within patient clinics.

For further information contact: 

Small Pharma

Peter Rands Chief Executive Officer

Email: ir@smallpharma.co.uk  

Tel: +44 (0)20 7112 9118

Media Relations Contacts:

USA: 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 

Tel: +1 (646)-889-1200

Kristi Papanikolaw

KCSA Strategic Communications

Email: smallpharmair@kcsa.com
Tel: +1 (212) 682-6300

Rest of World:

Jaber Mohamed

Email: smallpharma@mhpc.com

Tel: +44 (0)7720 326 487

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 release of key data from the Company’s SPL 026 Phase IIa clinical trials; the timeline for the anticipated launch of additional clinical trials; the Company’s ability to deliver novel treatments and build its reputation as a world leader in alternative treatments for mental health; 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 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 (“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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Awakn Provides a Business & Corporate Update

Awakn Provides a Business & Corporate Update

TORONTO, CANADA, July 15, 2022 – Awakn Life Sciences Corp. (NEO: AWKN) (OTCQB: AWKNF) (FSE: 954) (‘Awakn’), a revenue-generating biotechnology company researching, developing, and commercializing therapeutics to treat addiction with a near-term focus on Alcohol Use Disorder (AUD) is today providing a business and corporate update.

  • Awakn launches ‘Beta’ phase of its Licensing and Partnerships business in North America.  Awakn has signed Memorandum of Understanding (MOU) documents with multiple well-established Clinics in North America. Once full agreements are signed, the clinics will be given access to Awakn’s proprietary ketamine-assisted therapy for the treatment of Alcohol Use Disorder (AUD). Awakn’s treatment is backed by the successful Phase II b trial which resulted in 86% abstinence at 6-months post treatment. The ‘Beta’ phase will precede the full launch which is targeted for early 2023. Awakn will work with its license partners to fine tune the roll out of the treatment in advance of the full launch.
  • Awakn has initiated its Innovative Licensing and Access Pathway (ILAP) application for its lead program Project Kestrel. The ILAP is a UK government run initiative that supports innovative approaches to the safe, timely and efficient development of medicines.  Awakn aims to accelerate the time to market for its ketamine-assisted therapy for AUD, eventually facilitating patient access to this treatment on the National Health Service (NHS).
  • Awakn CFO, Kate Butler is leaving the Company, effective July 31, 2022, to pursue other opportunities. Awakn has commenced the search for a permanent CFO and for the interim period Jonathan Held, Chief Business Officer, Co-founder and previous CFO has been appointed as interim CFO.
  • Awakn has filed a Patent Cooperation Treaty (PCT) for MDMA-assisted therapy for the treatment of AUD. This patent allows Awakn the freedom to operate and pursue its promising research and results from its Phase II a trial.
  • In 2021, Awakn signed a Letter of Intent (LOI) with the psychedelic company Mindcure. It was intended that Mindcure would provide their therapeutic software application (iSTRYM) as a digital system to be used in Awakn’s Licensing Partnerships. Mindcure have recently announced following a strategic review they have ceased all research projects. As a result of this development, Awakn will not be pursuing an agreement with Mindcure.

Awakn CEO, Anthony Tennyson commented “We are delighted to see our Licensing Partnerships business move into its ‘Beta’ phase as we execute on our strategy of commercializing our therapeutics. I would also like to thank Kate Butler for all her work with Awakn and wish her the very best in her next venture.”

About Awakn Life Sciences Corp.

Awakn Life Sciences Corp. is a revenue-generating biotechnology company researching, developing, and commercialising therapeutics to treat substance and behavioral addictions.  Awakn has a near-term focus on Alcohol Use Disorder (AUD), a condition affecting 400m people globally for which the current standard of care is inadequate. Our goal is to provide effective therapeutics to addiction sufferers in desperate need and our strategy is focused on commercializing our R&D pipeline across multiple channels. 

www.AwaknLifeSciences.com  |  Twitter  |  LinkedIn  |  Facebook | www.AwaknClinics.com

About Project Kestrel

Project Kestrel is the lead clinical development program of Awakn Life Sciences.  Project Kestrel is supported by Awakn’s Phase II a/b ‘KARE’ clinical trial which examined ketamine-assisted therapy for the treatment of Alcohol Use Disorder (AUD).  The trial resulted in patients experiencing on average 86% abstinence at 6 months post treatment versus 2% before the trial which means that study participants went from being sober on average 7 days a year to being sober on average 314 days a year.  Awakn is planning to initiate a Phase III trial in the UK in 2022 and plans to seek regulatory approval in the UK and the US in due course.

Notice Regarding Forward-Looking Information

This news release contains certain forward-looking information and forward-looking statements, as defined in applicable securities laws (collectively referred to herein as “forward-looking statements”). Forward-looking statements reflect current expectations or beliefs regarding future events or the Company’s future performance. All statements other than statements of historical fact are forward-looking statements. Often, but not always, forward-looking statements can be identified by the use of words such as “plans”, “expects”, “is expected”, “budget”, “scheduled”, “estimates”, “continues”, “forecasts”, “projects”, “predicts”, “intends”, “anticipates”, “targets” or “believes”, or variations of, or the negatives of, such words and phrases or state that certain actions, events or results “may”, “could”, ”would”, “should”, “might” or “will” be taken, occur or be achieved, including statements relating the business of the Company. All forward-looking statements, including those herein are qualified by this cautionary statement.

Although the Company believes that the expectations expressed in such statements are based on reasonable assumptions, such statements are not guarantees of future performance and actual results or developments may differ materially from those in the statements. There are certain factors that could cause actual results to differ materially from those in the forward-looking information. These include, but are not limited to:COVID-19; fluctuations in general macroeconomic conditions; the business plans and strategies of the Company; the ability of the Company to comply with all applicable governmental regulations in a highly regulated business; the inherent risks in investing in target companies or projects which have limited or no operating history and are engaged in activities currently considered illegal in some jurisdictions; changes in laws; limited operating history; reliance on management; requirements for additional financing; competition; fluctuations in securities markets; inconsistent public opinion and perception regarding the medical-use of psychedelic drugs; expectations regarding the size of the addiction market; and regulatory or political change. Readers are cautioned that the foregoing list of factors is not exhaustive of the factors that may affect forward-looking statements. Accordingly, readers should not place undue reliance on forward-looking statements. The forward-looking statements in this news release speak only as of the date of this news release or as of the date or dates specified in such statements.

Investors are cautioned that any such statements are not guarantees of future performance and actual results or developments may differ materially from those projected in the forward-looking information. For more information on the Company, investors are encouraged to review the Company’s public filings on SEDAR at www.sedar.com. The Company disclaims any intention or obligation to update or revise any forward- looking information, whether as a result of new information, future events or otherwise, other than as required by law.

This news release does not constitute an offer to sell, or a solicitation of an offer to buy, any securities in the United States. The Company’s and Awakn’s securities have not been and will not be registered under the United States Securities Act of 1933, as amended (the “U.S. Securities Act”) or any state securities laws and may not be offered or sold within the United States or to U.S. Persons unless registered under the U.S. Securities Act and applicable state securities laws or an exemption from such registration is available.

Investor Enquiries:
Anthony Tennyson, CEO, Awakn Life Sciences
anthony.tennyson@awaknlifesciences.com

Media Enquiries:
America and Canada: KCSA Strategic Communications 
Anne Donohoe
Adonohoe@KCSA.com

Rest of World: Eat More Fruit Communications
Paul Jarman / Nora Popova
awakn@eatmorefruit.com

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Small Pharma Reports Fiscal First Quarter 2023 Highlights

Small Pharma Reports Fiscal First Quarter 2023 Highlights

– Progress continues apace with multiple trials expected to enter clinic later this year

– First US patent granted

LONDON, July 15 2022 (GLOBE NEWSWIRE) — Small Pharma Inc. (TSXV: DMT) (OTCQB: DMTTF) (the “Company” or “Small Pharma”), a biotechnology company focused on short-acting psychedelic-assisted therapies for mental health conditions, has today published its financial results for the quarter ended May 31, 2022. A full copy of the results can be found under the Company’s profile on SEDAR at www.sedar.com. Unless otherwise indicated, all currency references are in Canadian dollars.  

Financial Highlights 

  • Cash on hand as of May 31, 2022 was $32.0 million. Cash is net of an unrealized loss of $2.3 million arising from foreign exchanges incurred due to a strengthening of the Canadian dollar against the British pound sterling (“GBP”) during the quarter; however, as most of the Company’s operating costs are incurred in GBP, the loss has little impact on the underlying cash burn of the Company.
  • Cash used in operating activities was $6.3 million for the three months ended May 31, 2022.
  • Operating expenses for the three months ended May 31, 2022 were $5.8 million.
Business Highlights (including post-period events)

Ultra Short-acting Psychedelic Program

  • Progress continues in the Phase I/IIa clinical trial of the Company’s lead program, SPL026 intravenous (“IV”) N,N-dimethyltryptamine (“DMT”) assisted psychotherapy for Major Depressive Disorder (“MDD”). Phase IIa patient dosing is expected to complete in the coming months. Updates on trial completion and topline data timing are anticipated throughout H2 2022.
  • Drug interaction Phase Ib study in MDD patients CTA submission complete; study expected to commence in H2 2022.
    • Assessment of safety, tolerability, pharmacokinetics and pharmacodynamics of DMT-assisted psychotherapy when administered with serotonin reuptake inhibitors (“SSRIs”), .
  • Preparation is ongoing for the Phase IIb international multi-site clinical trial.

Short-acting Psychedelic Programs

  • Phase I study evaluating SPL026 intramuscular (“IM”) is planned for H2 2022 to compare the treatment profile of IM and IV modes of administration.
  • Phase I study evaluating SPL028 deuterated DMT-assisted psychotherapy is planned for H2 2022.

Corporate Activity

  • Strong IP Portfolio with 8 granted patents and 75 patent applications pending across the Company’s psychedelic and non-psychedelic portfolio.
    • Two new patent grants in July 2022:
      • One patent received is a US patent that strengthens the company’s portfolio surrounding certain salt forms of 2R,6R-hydroxynorketamine (“6-HNK”), including SPL801B.
      • Second patent received is a European patent providing protection for high concentration oral dosage forms of 6-HNK salts, including SPL801B.
    • Continued participation in key investor events such as the PSYCH Symposium London, Jefferies Healthcare Conference and HC Wainwright Mental Health Conference.

Peter Rands, Chief Executive Officer of Small Pharma, said:

The remainder of 2022 is expected to be a busy one for our team as we approach the latter stages of the SPL026 Phase IIa clinical trial and prepare to progress a number of new planned trials into the clinic. Although across the world, our industry is facing challenging markets right now, we believe that Small Pharma remains in a strong position with our world-class team, robust pipeline and strong cash position as we strive to change the therapeutic paradigm for these much underserved patients with the option of better mental health treatments.”

About Small Pharma

Small Pharma is a biotechnology company progressing a pipeline of short-acting psychedelics with therapy for the treatment of mental health conditions, with a current focus on depression. Small Pharma initiated a clinical program into DMT-assisted psychotherapy in February 2021. This program includes a Phase I/IIa trial on the Company’s lead candidate alongside the development of a 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 (< 30 mins), which allows for short treatment sessions and offers the potential for convenient supervised treatments within patient clinics.

For further information contact: 

Small Pharma

Peter Rands Chief Executive Officer

Email: ir@smallpharma.co.uk  

Tel: +44 (0)20 7112 9118

Media Relations Contacts:

USA: 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 

Tel: +1 (646)-889-1200

Kristi Papanikolaw

KCSA Strategic Communications

Email: smallpharmair@kcsa.com
Tel: +1 (212) 682-6300

Rest of World:

Jaber Mohamed

Email: smallpharma@mhpc.com

Tel: +44 (0)7720 326 487

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 Company’s continued progression of Phase IIa clinical trials of SPL026 IV, including the expected timeline for completion of patient dosing, trial progress and the release of the Phase IIa data; the expected timeline for commencing a drug interaction patient study assessing the impact of SSRIs; the Company’s preparation for the international multi-site Phase IIb clinical trial of SPL026; the Company’s plans, expectations, timelines and possible outcomes with respect to its anticipated SPL026 study comparing IM versus IV modes of administration as well as the Company’s Phase I study of SPL028 deuterated DMT-assisted psychotherapy; the Company’s ability to pursue novel treatments to provide better mental health treatments; 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 U.K. Medicines and Healthcare Products Regulatory Agency (the “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 (“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.

Posted on

Zylorion Announces Filing of U.S. Provisional Patent For Novel Second-Generation Psilocybin-Based Compound

Zylorion Announces Filing of U.S. Provisional Patent For Novel Second-Generation Psilocybin-Based Compound

CALGARY, AB, July 14, 2022 /CNW/ –  PsiloTec Health Solutions Inc., operating as Zylorion Health, (“Zylorion” or the “Company”), a precision mental health care and psychedelic therapy focused innovator, is pleased to announce the filing of the Company’s third provisional patent application with the United States Patent and Trademark Office (“USPTO”).

The provisional patent application covers the composition of matter of Zylorion’s novel psilocybin-based compound, ZYL-314, for the treatment of mental health disorders and other central nervous system conditions and cognitive disorders.

“Our clinical team has been working tirelessly with our research partners on the development of novel second generation and industry leading compounds, and we are extremely excited about this discovery,” commented Dr. Peter Silverstone, Chief Executive Officer. “ZYL-314 is truly unique and achieving this milestone demonstrates Zylorion’s commitment to bringing innovative new therapies to market and creating long-term shareholder value through a strong portfolio of intellectual property assets”.    

The Company continues to gather the necessary data and evidence to support the claims and conversion of the composition of matter provisional patent and anticipates filing an application under the PCT (Patent Cooperation Treaty) within the next twelve months.

About Zylorion

Zylorion is a biotech company engaged in the development and delivery of integrated precision mental health therapies to address psychological and neurological mental health conditions. Zylorion is focused on the research, development and commercialization of psychedelic-based compounds coupled with novel therapeutic treatment programs targeting a continuum of mental health conditions, such as MDD (major depressive disorder), TRD (treatment resistant depression), PTSD (post-traumatic stress disorder), general depression, anxiety disorders, and a number of addictive tendencies. Zylorion aims to leverage leading technologies to support the scalability and accessibility of its integrated therapy programs in its mission to enable those experiencing mental health challenges to thrive. Cautionary Note Regarding Forward-Looking Statements

This news 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.

SOURCE Zylorion

For further information: Investor Relations, e: InvestorRelations@zylorion.com ; General Enquiries & Media Relations, e: Info@zylorion.com, www.zylorion.com

Posted on

Doseology Expands into US Retail Market

Doseology Expands into US Retail Market

Vernon, British Columbia, July 14, 2022 – Doseology Sciences Inc. (CSE: MOOD) (OTCQB: DOSEF) (FSE: VU7) (“Doseology” or the “Company”), a life sciences company focused on mental health and wellness, is excited to announce it has signed a Sales Management Agreement with Alternative Sales Management to act as the Company’s national sales manager for its expansion into the United States retail market.

Gary Gobeli, President of Alternative Sales Management, is a skilled Master Broker and Senior Manager within the natural and organic industry. With over three decades of experience, Gobeli brings a set of skills and experiences that has led to success for both him and his partners — he has been a distributor and manufacturer rep, owned a brokerage company, and has been a regional and national sales manager for top brands such as Atkins and Symbiotics. He is an expert in evaluating market trends, developing and implementing goal-oriented strategies, networking with manufacturers and distributors, and bringing both start-ups and bigger brands to market.

The engagement of Alternative Sales Management comes at an opportune time, as the functional mushroom market continues to grow in the United States in 2022. Notably, Tastewise predicts a continued interest in functional foods with 33% more consumers treating food as medicine in 2022 compared to 2020.

The benefits of functional mushrooms have been the subject of intense study in recent years. For example, a 2021 study by Penn State College of Medicine found that consistently consuming mushrooms resulted in a lower risk of depression. This effect is attributed to certain edible mushrooms, such as lion’s mane, having the potential to enhance neuron production and survival, which can help prevent neuropsychiatric disorders, such as depression. There are thousands of other studies that highlight the benefits of these fungi.

Further projections for the functional mushroom market include an 8.44% compound annual growth rate from a projected surge in demand for functional foods and nutraceuticals from 2021 to 2026. Additionally, the global market is expected to reach $44.8B USD by 2027.

Doseology will capitalize on this increased interest with its expansion into the sizable United States retail market. The Company plans to partner with distributors that specialize in supplements and target independent retailers and specialty chains to build a strong foundation before moving on to mass-market retailers.

The current functional mushroom products in Doseology’s US line are:

  • Wake: Blend of lion’s mane mushroom fruiting bodies, yerba mate, and vitamins B6 and B12 to promote wakefulness and to support cognitive performance (tincture, 28 servings).
  • Elevate: Blend of lion’s mane mushroom fruiting bodies, ginger root, and vitamin B3 to elevate mood and enhance cognitive clarity (tincture, 28 servings).
  • Active: Blend of cordyceps mushroom fruiting bodies and rhodiola to promote energy, enhance physical performance, and ease mental fatigue (tincture, 28 servings).
  • Recover: Blend of shiitake fruiting bodies and turmeric to provide the body with potent antioxidants to strengthen and support immunity (tincture, 28 servings).
  • Rest: Blend of reishi mushroom fruiting bodies, German chamomile, and melatonin to promote relaxation and sleep onset (tincture, 28 servings).
  • Think: Blend of the fruiting bodies of lion’s mane mushroom, reishi, shiitake, and chaga, yerba mate, rhodiola, choline, organic cocoa powder, and monk fruit extract. The super-shroom cognitive complex is formulated to give the brain the building blocks it needs to optimize cognitive function and to improve focus and alertness (cognitive complex powder, 30 servings).
  • Defend: Blend of the fruiting bodies of lions’ mane, reishi, shiitake, turkey tail, chaga, maitake, royal sun agaricus, white button, and black fungus as well as the mycelium of cordyceps. These 10-in-1 super shroom capsules are formulated to provide daily immune support (mushroom capsules, 30 servings).

For sales inquiries contact hello@doseology.com

About Doseology Sciences (CSE: MOOD) (OTCQB: DOSEF) (FSE: VU7)
Doseology Sciences Inc. is building a progressive brand focused on mental health and wellness through cultivation, extraction and innovative nutraceutical and pharmaceutical products. Doseology aims to make a meaningful impact on the mental health pandemic by utilizing and developing functional fungi and plant-derived drugs. With a vertically integrated approach, Doseology intends to process and distribute products at its facilities in Vernon, British Columbia, in accordance with applicable laws to ensure safe and high-quality production. Doseology’s medicinal mushroom products, including tinctures, powders and supplements, are available on doseology.com.

For further information contact:
Investor Relations: investor@doseology.com
General Inquiries: hello@doseology.com
Telephone: 236-349-0064
Website: doseology.com

Forward-Looking Statements
This press release contains statements that constitute “forward‐looking information” within the meaning of applicable securities laws. Forward‐looking information is often identified by the words “may,” “would,” “could,” “should,” “will,” “intend,” “plan,” “anticipate,” “believe,” “estimate,” “expect” or similar expressions. Readers are cautioned that forward‐looking information is not based on historical facts but instead reflects the Company’s management’s expectations, estimates or projections concerning the business of the Company’s future results or events based on the opinions, assumptions and estimates of management considered reasonable at the date the statements are made. 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. Among the key factors that could cause actual results to differ materially from those projected in the forward‐looking information are the following: changes in general economic, business and political conditions, including changes in the financial markets; decreases in the prevailing prices for products in the markets that the Company operates in; adverse changes in applicable laws or adverse changes in the application or enforcement of current laws; regulations and enforcement priorities of governmental authorities; compliance with government regulation and related costs; and other risks described in the Company’s prospectus. Should one or more of these risks or uncertainties materialize, or should assumptions underlying the forward‐looking information prove incorrect, actual results may vary materially from those described herein as intended, planned, anticipated, believed, estimated, or expected. Although the Company has attempted to identify important risks, uncertainties and factors which could cause actual results to differ materially, there may be others that cause results not to be as anticipated, estimated or intended. The Company does not intend, and does not assume any obligation, to update this forward‐looking information except as otherwise required by applicable law. For more information, investors should review the Company’s filings which are available on SEDAR.

No securities regulatory authority has either approved or disapproved of the contents of this press release. The Company’s securities have not been, nor will they be, registered under the United States Securities Act of 1933, as amended, or any state securities laws, and may not be offered or sold in the United States, or to or for the account or benefit of any person in the United States, absent registration, or an applicable exemption from the registration requirements. This press release shall not constitute an offer to sell or the solicitation of an offer to buy any securities in the United States, or in any other jurisdiction in which such offer, solicitation or sale would be unlawful.

Industry Data
This press release includes market, industry and economic data which was obtained from various publicly available sources and other sources believed by the Company to be true. Although the Company believes it to be reliable, the Company has not independently verified any of the data from third party sources referred to in this press release, or analyzed or verified the underlying reports relied upon or referred to by such sources, or ascertained the underlying economic and other assumptions relied upon by such sources. The Company believes that its market, industry and economic data is accurate and that its estimates and assumptions are reasonable, but there can be no assurance as to the accuracy or completeness thereof. The accuracy and completeness of the market, industry and economic data used throughout this press release are not guaranteed and the Company does not make any representation as to the accuracy or completeness of such information.

The CSE does not accept responsibility for the adequacy or accuracy of this release.

Posted on

Enveric Biosciences Announces Reverse Stock Split

Enveric Biosciences Announces Reverse Stock Split

Common Stock Will Begin Trading on a Split-Adjusted Basis on July 15, 2022

CAMBRIDGE, Mass. –Enveric Biosciences, Inc. (NASDAQ: ENVB) (“Enveric” or the “Company”), a neuroscience-focused biotechnology company developing next-generation, psychedelic-inspired mental health medicines, today announced that it intends to effect a reverse stock split of its common stock at a ratio of 1 post-split share for every 50 pre-split shares. The reverse stock split will become effective at 4:05 p.m., New York time, on Thursday, July 14, 2022. Enveric’s common stock will continue to be traded on the Nasdaq Capital Market under the symbol “ENVB” and will begin trading on a split-adjusted basis when the market opens on Friday, July 15, 2022.

At a special meeting of stockholders held on July 14, 2022, Enveric’s stockholders granted the Company’s Board of Directors the discretion to effect a reverse stock split of Enveric’s common stock through an amendment to its Amended and Restated Certificate of Incorporation, as amended, at a ratio of not less than 1-for-10 and not more than 1-for-100, such ratio to be determined by the Company’s Board of Directors.

At the effective time of the reverse stock split, every 50 shares of Enveric’s issued and outstanding common stock will be converted automatically into one issued and outstanding share of common stock without any change in the par value per share. Stockholders holding shares through a brokerage account will have their shares automatically adjusted to reflect the 1-for-50 reverse stock split. It is not necessary for stockholders holding shares of the Company’s common stock in certificated form to exchange their existing stock certificates for new stock certificates of the Company in connection with the reverse stock split, although stockholders may do so if they wish.

The reverse stock split will affect all stockholders uniformly and will not alter any stockholder’s percentage interest in the Company’s equity, except to the extent that the reverse stock split would result in a stockholder owning a fractional share. Any fractional share of a stockholder resulting from the reverse stock split will be rounded up to the nearest whole number of shares. The reverse stock split will reduce the number of shares of Enveric’s common stock outstanding from 52,684,548 shares to approximately 1,053,691 shares. Proportional adjustments will be made to the number of shares of Enveric’s common stock issuable upon exercise or conversion of Enveric’s equity awards and warrants, as well as the applicable exercise price. Stockholders whose shares are held in brokerage accounts should direct any questions concerning the reverse stock split to their broker. All stockholders of record may direct questions to the Company’s transfer agent, American Stock Transfer & Trust Company, LLC, at 1-877-248-6417 or 1-718-921-8317.

About Enveric Biosciences

Enveric Biosciences, Inc. (NASDAQ: ENVB) is a neuroscience-focused pharmaceutical company developing next-generation, psychedelic-inspired mental health medicines. Enveric’s robust pipeline supports drug development from the clinic to commercialization aimed to help millions of patients in need around the world suffering from conditions that include cancer-related distress, PTSD and more. For additional information, please visit www.enveric.com.

Forward-Looking Statements

This press release contains forward-looking statements and forward-looking information within the meaning of applicable securities laws. These statements relate to future events or future performance. All statements other than statements of historical fact may be forward-looking statements or information. Generally, forward-looking statements and information may be identified by the use of forward-looking terminology such as “plans,” “expects” or “does not expect,” “proposed,” “is expected,” “budgets,” “scheduled,” “estimates,” “forecasts,” “intends,” “anticipates” or “does not anticipate,” or “believes,” or variations of such words and phrases, or by the use of words or phrases which state that certain actions, events or results may, could, would, or might occur or be achieved. Forward-looking statements consist of not purely historical statements, including any statements regarding beliefs, plans, expectations, or intentions regarding the future. Such forward-looking statements are based on the beliefs of management as well as assumptions made by and information currently available to management. Actual results could differ materially from those contemplated by the forward-looking statements as a result of certain factors, including, but not limited to, the effect that the reverse stock split may have on the price of our common stock; our ability to retain our listing on the Nasdaq Capital Market; the ability of the company to successfully spin-off its cannabinoid assets; the ability to achieve the value creation contemplated by technical developments; the impact of the novel coronavirus (COVID-19) on Enveric’s ongoing and planned clinical trials; the geographic, social and economic impact of COVID-19 on Enveric’s ability to conduct its business and raise capital in the future when needed; delays in planned clinical trials; the ability to establish that potential products are efficacious or safe in preclinical or clinical trials; the ability to establish or maintain collaborations on the development of therapeutic candidates; the ability to obtain appropriate or necessary governmental approvals to market potential products; the ability to obtain future funding for developmental products and working capital and to obtain such funding on commercially reasonable terms; Enveric’s ability to manufacture product candidates on a commercial scale or in collaborations with third parties; changes in the size and nature of competitors; the ability to retain key executives and scientists; and the ability to secure and enforce legal rights related to Enveric’s products, including patent protection. A discussion of these and other factors, including risks and uncertainties with respect to Enveric, is set forth in Enveric’s filings with the Securities and Exchange Commission (SEC), including the Company’s Annual Report on Form 10-K and its Quarterly Reports on Form 10-Q. Enveric disclaims any intention or obligation to revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.

Investor Contacts

Valter Pinto

KCSA Strategic Communications

212.896.1254

valter@kcsa.com

Media Contacts

Allison Soss

KCSA Strategic Communications

212.896.1267

asoss@kcsa.com

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Greenbrook TMS Announces Closing of Success TMS Acquisition and US$75 Million Credit Facility With Madryn Asset Management

Greenbrook TMS Announces Closing of Success TMS Acquisition and US$75 Million Credit Facility With Madryn Asset Management

July 14, 2022 05:02 PM Eastern Daylight Time

TORONTO–(BUSINESS WIRE)–Greenbrook TMS Inc. (TSX: GTMS, NASDAQ: GBNH) (“Greenbrook” or the “Company”), a leading provider of Transcranial Magnetic Stimulation (“TMS”) therapy in the United States, is pleased to announce the closing of its previously-announced acquisition (the “Acquisition”) of Check Five LLC, a Delaware limited liability company (doing business as “Success TMS”) (“Success TMS”). In addition, Greenbrook announces today that it and its subsidiaries have entered into a credit agreement for a US$75 million secured credit facility (the “Credit Facility”) with Madryn Asset Management, LP (“Madryn”) and its affiliated entities.

“We are very excited to announce the closing of the Acquisition and the Credit Facility today as we believe this to be transformational for the Company”Tweet this

Key Acquisition and Credit Facility highlights:

  • Adding Significant Operating Scale, Top-Line Growth and Expected to Accelerate the Path to Profitability
    • The Company believes the Acquisition of Success TMS’ 47 TMS centers in the states of Florida, Pennsylvania, Illinois, New Jersey, Nevada and Wisconsin is highly complementary to Greenbrook’s existing management regions.
    • The Company expects that the Acquisition has the potential to add more than US$30 million in consolidated revenues to the combined company on a full-year basis, representing significant growth over Greenbrook’s current fiscal 2021 revenues of approximately US$52 million.
    • The Company anticipates that near term post-Acquisition synergies may be able to produce EBITDA positive operations for the combined company and accelerate the Company’s timeline to profitability.
    • The Company believes it has the ability to layer on its existing Spravato® program across the Success TMS footprint to drive further growth.
  • Recapitalization of the combined business through the Credit Facility
    • The Credit Facility provides Greenbrook with immediate access of up to US$55 million in term loans and the potential to access up to an additional US$20 million in loans exclusively for expansion purposes.
    • The Company believes the Credit Facility sufficiently capitalizes the business to serve its general working capital needs and to execute on its growth strategy.
    • The Company believes the Credit Facility represents a significant vote of confidence by a leading healthcare investor.
  • Well-Established Payor Contracting and Access to Robust Physician Networks
    • The Company believes that Success TMS’ affiliated medical practices benefit from strong reimbursement and provides access to a reputable physician network, which removes the need to establish new contractual relationships with payors in the regions in which Success TMS currently operates, eliminating a process which is a key barrier to expansion.
  • Provides Proven Regional Management Team and Potential Synergies
    • Success TMS has an experienced management and operations team.
    • Success TMS’ Chief Executive Officer, Benjamin Klein, has joined the Company as Chief Operating Officer and a member of the Company’s board of directors, deepening Greenbrook’s managerial expertise, and combining best practices of Greenbrook and Success TMS.
  • All Equity Transaction to Build Value Together
    • Purchase price consideration for the Acquisition payable entirely in common shares of Greenbrook which is intended to align the interests of the Success TMS team with those of Greenbrook and promote the shared goal of building value together under the Greenbrook brand.

“We are very excited to announce the closing of the Acquisition and the Credit Facility today as we believe this to be transformational for the Company,” said Bill Leonard, President and Chief Executive Officer of Greenbrook. “We believe these transactions accelerate Greenbrook’s ability to grow and gives us the needed capitalization to further expand on our mental health platform, through our base TMS business, expanding Spravato® program, and other future treatment modalities and indications. We are excited to begin working with Ben Klein as our new COO and our new colleagues at Success TMS who share our passion for TMS therapy and delivering exceptional patient care to those suffering from mental health disorders. We believe our business is a needed one in a time of heightened demand for mental health support.”

“We believe Greenbrook’s innovative approach to treating mental health can help the millions of individuals who suffer from Major Depressive Disorder yet struggle to benefit from traditional treatment modalities,” said Dr. Avinash Amin, Managing Partner of Madryn. “We are excited to support Greenbrook and look forward to a collaborative partnership with their management team as they continue to revolutionize the treatment of mental health disorders and expand the TMS footprint.”

Success TMS Acquisition

Pursuant to the purchase agreement, Greenbrook, through its wholly-owned U.S. subsidiary, TMS NeuroHealth Centers Inc., has acquired all of the issued and outstanding equity interests in Success TMS from its parent company, Success Behavioral Holdings, LLC. As consideration for the purchase of Success TMS, its direct and indirect owners (collectively, the “Seller Parties”) have received, in the aggregate, 8,725,995 common shares of Greenbrook (the “Consideration Shares”), and an additional 2,908,665 Consideration Shares have been held back and deposited with an escrow agent, to be released to Benjamin Klein or Greenbrook, as applicable, upon satisfaction of customary working capital and certain other adjustments, including to satisfy any indemnity claims against the Seller Parties.

The purchase price consideration was determined based on the pro forma revenue contribution of the two companies and was fixed at an amount equal to approximately 40% of the total issued and outstanding common shares of Greenbrook (the “Common Shares”) on a post-Acquisition basis and subject to adjustments, as described above.

The Seller Parties are subject to a 12-month lock-up period in respect of the Common Shares issued or issuable to them in connection with the Acquisition. The Seller Parties have also received certain customary registration rights in connection with the resale of the Common Shares acquired by them in the Acquisition, once the lock-up restrictions have expired.

Success TMS is one of the largest providers of TMS therapy in the United States. Since founding its first TMS center in Florida in 2018, Success TMS has grown to 47 active locations throughout Florida, Pennsylvania, Illinois, New Jersey, Nevada and Wisconsin. The Acquisition has added 47 active TMS centers to Greenbrook’s existing service delivery platform, bringing its total to 193 active TMS centers across the United States. The Acquisition has also provided Greenbrook with a new presence in additional states, including new management regions in Illinois, New Jersey, Nevada, Pennsylvania and Wisconsin.

As previously disclosed, the purchase agreement for the Acquisition provides Benjamin Klein with a right to nominate a single representative to the board of directors of Greenbrook for so long as the Seller Parties own at least 5% of the issued and outstanding Common Shares, subject to certain conditions, including applicable securities laws and stock exchange requirements. Benjamin Klein has been appointed to the board of directors as the board nominee, effective immediately.

Debt Financing

The Credit Facility provides Greenbrook with a US$55 million term loan, which was funded on closing. In addition, the Credit Facility permits Greenbrook to incur up to an additional US$20 million in a single draw at any time on or prior to December 31, 2024 for purposes of funding future M&A activity. All amounts borrowed under the Credit Facility will bear interest at a rate equal to the three-month LIBOR rate plus 9.0%, subject to a minimum three-month LIBOR floor of 1.5%. The Credit Facility matures over 63 months and provides for four years of interest-only payments.

The Credit Facility also provides Madryn with the option to convert up to US$5 million of the outstanding principal amount of the loan into Common Shares at a price per share equal to a 15% premium to the 30-day volume weighted average trading price of the Common Shares as of the closing date of the transaction, subject to customary anti-dilution adjustments and approval of the Toronto Stock Exchange (“TSX”) prior to each such issuance. The Company has notified The Nasdaq Stock Market LLC (“Nasdaq”) in accordance with the rules of that exchange.

Greenbrook has used approximately US$10.1 million of the proceeds from the Credit Facility to repay in full the outstanding balance owing under the Company’s existing term loan with Oxford Finance LLC (the “Oxford Facility”) and has terminated the Oxford Facility.

Bloom Burton Securities Inc. acted as the Company’s sole financial adviser in connection with the debt financing.

About Greenbrook TMS Inc.

Operating through 193 Company-operated treatment centers (including those added through the Acquisition), Greenbrook is a leading provider of TMS therapy, an FDA-cleared, non-invasive therapy for the treatment of Major Depressive Disorder and other mental health disorders, in the United States. TMS therapy provides local electromagnetic stimulation to specific brain regions known to be directly associated with mood regulation. Greenbrook has provided more than 840,000 TMS treatments to over 24,000 patients struggling with depression.

About Madryn Asset Management, LP.

Madryn Asset Management is a leading alternative asset management firm that invests in innovative healthcare companies specializing in unique and transformative products, technologies, and services. The firm draws on its extensive and diverse experience spanning the investment management and healthcare industries, and employs an independent research process based on original insights to target attractive economic opportunities that deliver strong risk-adjusted and absolute returns for its limited partners while creating long-term value in support of its portfolio companies.

Cautionary Note Regarding Forward-Looking Information

Certain information in this press release, including statements regarding the debt financing and the Acquisition, the potential benefits and synergies to be derived therefrom, expectations regarding future profitability, and the number of Common Shares issuable in connection therewith, constitute forward-looking information within the meaning of applicable securities laws in Canada and the United States, including the United States Private Securities Litigation Reform Act of 1995. In some cases, but not necessarily in all cases, forward-looking information can be identified by the use of forward-looking terminology such as “plans”, “targets”, “expects” or “does not expect”, “is expected”, “an opportunity exists”, “is positioned”, “estimates”, “intends”, “assumes”, “anticipates” or “does not anticipate” or “believes”, or variations of such words and phrases or state that certain actions, events or results “may”, “could”, “would”, “might”, “will” or “will be taken”, “occur” or “be achieved”. In addition, any statements that refer to expectations, projections or other characterizations of future events or circumstances contain forward-looking information. Statements containing forward-looking information are not historical facts but instead represent management’s expectations, estimates and projections regarding future events.

Forward-looking information is necessarily based on a number of opinions, assumptions and estimates that, while considered reasonable by the Company as of the date of this press release, are subject to known and unknown risks, uncertainties, assumptions and other factors that may cause the actual results, level of activity, performance or achievements to be materially different from those expressed or implied by such forward-looking information, including, but not limited to, the factors described in greater detail in the “Risk Factors” section of the Company’s annual report on Form 20-F for the fiscal year ended December 31, 2021 and in the Company’s other materials filed with the Canadian securities regulatory authorities and the United States Securities and Exchange Commission from time to time, available at www.sedar.com and www.sec.gov, respectively. These factors are not intended to represent a complete list of the factors that could affect the Company or its ability to achieve the potential benefits and synergies from the Acquisition and its expectations regarding future profitability; however, these factors should be considered carefully. There can be no assurance that such estimates and assumptions will prove to be correct. The forward-looking statements contained in this press release are made as of the date of this press release, and the Company expressly disclaims any obligation to update or alter statements containing any forward-looking information, or the factors or assumptions underlying them, whether as a result of new information, future events or otherwise, except as required by law.

Contacts

Glen Akselrod
Investor Relations
Greenbrook TMS Inc.

Contact Information:
investorrelations@greenbrooktms.com