Mindset Pharma CEO, James Lanthier, Issues Letter to Shareholders

TORONTO, March 17, 2022 (GLOBE NEWSWIRE) -- Mindset Pharma Inc. (CSE: MSET) (FSE: 9DF) (OTCQB: MSSTF) ("Mindset" or the "Company"), a drug discovery and development company focused on creating optimized and patentable next-generation psychedelic medicines to treat neurological and psychiatric disorders with unmet medical needs, today issued a letter to shareholders from James Lanthier, Chief Executive Officer of Mindset.

Dear Fellow Shareholders:

As we continue to diligently advance our development pipeline, I would like to take a moment to provide an update on our efforts, highlighting our current partnership with the McQuade Center for Strategic Research and Development (MSRD), a member of the global Otsuka family of pharmaceutical companies, our clinical strategy, and development progress across our pipeline of innovative compounds, which provide a de-risked and well-supported path to the clinic.

MSRD Partnership Validates Mindset's Psychedelic Drug Development Approach and Provides Ongoing Funding

The partnership with MSRD is a major milestone, not only for Mindset but for the broader medical psychedelic industry. This partnership represents a bridge from traditional big Pharma to the new emerging world of psychedelic medicine, which is an industry first. The fact that Mindset spearheaded the first partnerships with big pharma is a testament to our world class innovations and quality of our science and rigorous drug development and validates our strategy for second generation, optimized drug discovery approach.

This partnership provides ongoing funding of development expenses needed to bring clinical candidates from Mindset's Families 2 and 4 of next-generation psilocybin and 5-MeO-DMT compounds, respectively, through Phase 1a and Phase 1b human clinical trials, and in addition, a payment to Mindset in the amount of US$5 million. This collaboration supports both Mindset and Otsuka's mission to provide mental health solutions to a massive, underserved, population.

MSRD has extensive regulatory and clinical expertise that will be instrumental in developing a successful human clinical framework. We are excited to further collaborate and explore additional opportunities with MSRD with the aim of broadening access to safe and effective mental health treatments.

Development Platform Enables Multiple Clinical Opportunities for a Variety of Modalities

In addition to our Families 2 and 4 compounds, we continue to evaluate and collect a strong critical data package for our psilocybin-inspired Families 1 and 3 drug candidates.

In Family 1, we identified a lead drug candidate, MSP-1014, which we believe is well-suited to address Treatment-Resistant Depression and End-of-Life Cancer Angst. In preclinical studies, MSP-1014 has demonstrated an improved efficacy and safety profile compared to first-generation psilocybin. Due to its differentiated characteristics, it is considered a new chemical entity (NCE) and we have developed a patent strategy to protect this asset. Early in 2022, we secured a leading contract manufacturer to produce pharmaceutical grade batches of MSP-1014 for IND-enabling studies and subsequent human phase 1 clinical trials l. While we continue collecting data, we are pursuing development partners to support the clinical process.

In Family 3, we identified compounds that have potential to treat a range of mental health disorders in the form of daily, take-home, medications. Our preclinical data suggests that, a range of doses may be sub-hallucinogenic doses, and we plan to examine this class of compounds for pro-cognitive benefits. The ability to provide pro-cognitive solutions without a psychedelic effect will suit vulnerable patient populations such as juvenile ADHD, Alzheimer's disease, and a range of other psychiatric disorders s. In late 2021, we filed an international patent to cover our Family 3 compounds. We plan to continue studying the effects of our Family 3 compounds through further preclinical animal models, but are extremely pleased and encouraged by our initial results.

Scientific Team with Expertise in Developing Novel CNS Drugs and Strong Industry Ties

Mindset's drug development program is led by its Chief Scientific Officer, Joseph Araujo, who brings over 20 years of research experience supporting CNS development programs, as well as executive experience at numerous biotech companies. Dr. Malik Slassi, is the SVP of Innovation at Mindset with over 30 years of Pharma and Biotech R&D and management experience, previously the founder, President & CSO of Fluorinov Pharm, which was acquired by Trillium Therapeutics in 2016.

Recently, Mindset hired Dr. Fiona Randall, as SVP of External Alliances and Scientific Strategy to support the Company's partnership strategy. Dr Randall is a trained neuroscientist with worldwide research and development experience in both neurological research and alliance management and execution.

I am extremely encouraged with the progress we've made so far in bringing novel mental health therapies one step closer to patients in need. We have a strong team and alliances in place to expedite our time-to-market and de-risk our drug development programs. We will continue to work hard on the research and development side to unlock new discoveries so that we can provide better insight into the pharmacological potential of psychedelic medicines, both for the industry at large and, one day, to help patients overcome a range of psychiatric disorders.

Sincerely,

James Lanthier
Chief Executive Officer

About Mindset Pharma Inc.
Mindset Pharma Inc. is a drug discovery and development company focused on creating optimized and patentable next-generation psychedelic medicines to treat neurological and psychiatric disorders with unmet needs. Mindset was established in order to develop next-generation pharmaceutical assets that leverage the breakthrough therapeutic potential of psychedelic drugs. Mindset is developing several novel families of next-generation psychedelic compounds, as well as an innovative process to chemically synthesize psilocybin in addition to its own proprietary compounds. The company has a co-development agreement with the McQuade Center for Strategic Research and Development, a member of the Otsuka Pharmaceuticals family of companies, for its short-duration compounds, Mindset Families 2 & 4.

For further information on Mindset, please visit our website at www.mindsetpharma.com.

For more information, please contact:

Investor Contact:
Allison Soss/Tim Regan
KCSA Strategic Communications
Email: [email protected]
Phone: 212-896-1267/ 347-487-6788
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Media Contact:
McKenna Miller
KCSA Strategic Communications
Email: [email protected] 
Phone: 949-606-6585

Company Contact:
James Lanthier, CEO
Email: [email protected]

Jason Atkinson, VP, Corporate Development
Email: [email protected]
Phone: 416-479-4094

Forward-Looking Information
This news release contains certain "forward-looking information" within the meaning of applicable securities law. Forward looking information is frequently characterized by words such as "plan", "expect", "project", "intend", "believe", "anticipate", "estimate", "may", "will", "would", "potential", "proposed" and other similar words, or statements that certain events or conditions "may" or "will" occur. These statements are only predictions. Forward-looking information is based on the opinions and estimates of management at the date the information is provided and is subject to a variety of risks and uncertainties and other factors that could cause actual events or results to differ materially from those projected in the forward-looking information. Additional information regarding risks and uncertainties relating to the Company's business are contained under the heading "Risk Factors" in the Company's annual information form for the financial year ended June 30, 2020 dated March 5, 2021. The forward-looking information included in this news release is made as of the date of this news release and the Company does not undertake an obligation to publicly update such forward-looking information to reflect new information, subsequent events or otherwise, except as required by applicable law.

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