The DEA is no longer banning these drugs

In January, the DEA proposed to ban 5 psychedelic drugs (4-OH-DiPT, 5-MeO-AMT, 5-MeO-MiPT, 5-MeO-DET, and DiPT) by classifying them as Schedule I substances.

After receiving significant pushback, the DEA has withdrawn the proposal.

Instead, the agency is requesting for the Department of Health and Human Services to conduct scientific and medical evaluations of the drugs to guide scheduling recommendations.

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This study could be a game changer

A new government-funded study will see if psilocybin can ease depression without producing a psychedelic effect – and no, we aren’t talking about microdosing…

At Toronto’s Centre for Addiction and Mental Health, adults with treatment-resistant depression will receive a full dose of psilocybin + 12 hours of therapy. 

What makes this study unique is that some patients will also receive a serotonin blocker, which will block the psychedelic or hallucinogenic effects of the psilocybin.

If benefits can be delivered while avoiding the trip, this could open up psilocybin therapy to those who aren’t typically candidates for the treatment, as well as people who don’t want to hallucinate. 

Learn how you can participate in the study here

First Phase 3 trial receives government funding

After receiving three ketamine therapy sessions in Awakn’s Phase 2 trial, patients with alcohol use disorder achieved an increase in abstinence from around 2% to 86%. This means they abstained from alcohol for an average of 162 of the 180 days following the treatment 👏

The results were so encouraging that the UK government granted the company CA$2.5M to fund Phase 3 of the trial.

The grant covers two-thirds of Awakn’s costs and marks the first time that a Phase 3 psychedelics trial has received government funding.

With 280 patients across 7 sites in the UK, it will be the largest ketamine-assisted therapy trial to date!

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2 years til medical legalization!

FDA approval of MDMA for PTSD and psilocybin for depression is anticipated within the next 24 months, according to a letter from the Department of Health and Human Services.

The department is also considering starting a federal task force dedicated to addressing complex issues surrounding psychedelics such as harm reduction and safety.

“Too many Americans are suffering from mental health and substance use issues, which have been exacerbated by the ongoing COVID-19 pandemic, and that we must explore the potential of psychedelic-assisted therapies to address this crisis,” the letter explains.

read more here

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.

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.”

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.

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.

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

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.