November 5, 2021
November 4, 2021
MINDCURE Provides Update on Studies and Clinical Trials
VANCOUVER, BC, Nov. 4, 2021 /CNW/ - Mind Cure Health Inc. (CSE: MCUR) (OTCQX: MCURF) (FRA: 6MH) ("MINDCURE" or the "Company"), a leader in advanced proprietary technology and research for psychedelics, is pleased to provide an operational progress update on the strategic initiatives of its operating segments - MINDCURE Research and MINDCURE Technology.
Synthetic Ibogaine Production Update
In March 2021, MINDCURE announced the initiation of chemical synthesis routes for the production of fully synthetic ibogaine. In July 2021, the Company applied for patents on two routes to full chemical synthesis and initiated the production of Good Laboratory Practice ("GLP") ibogaine leading to the production of Good Manufacturing Practice ("GMP") ibogaine in order to scale and manufacture a global supply of fully synthetic ibogaine. MINDCURE is currently on schedule and expects to have GLP supply available for research partners beginning in Q2 of 2022.
MINDCURE confirms that it is preparing to ship ibogaine drug material to its pre-clinical research partner. The material will initially be used for broad cardiac and neurologic screens, with the potential to conduct in-depth behavioral studies. This program has been identified as MSYNTH-001, and the Company expects results from the first studies during the first quarter of 2022.
In addition to advancing the scale of its synthetic ibogaine program, MINDCURE continues to explore options for drug pipeline expansion. Two candidate selection programs are currently underway, known internally as MC-106 and MC-808. The Company will provide further information on these programs in the second quarter of 2022.
Clinical Trial Update
MINDCURE has completed its draft research protocol for the use of MDMA and psychotherapy to treat female sexual hypoactive desire disorder, known as The Desire Project. The Company expects a pre-IND meeting with the FDA to be scheduled in the first quarter of 2022 and for its Phase 2 trial to begin by the third quarter of 2022. Further, site initiation and initial screening are planned for March 2022, with recruitment and enrollment to follow.
"We are proud to report that MINDCURE's core research programs are progressing rapidly, showcasing our disciplined commitment to advancing MINDCURE's drug research and commercial production programs. Concurrently, we maintain a focus on identifying opportunities to expand our drug development pipeline," said Kelsey Ramsden, President & Chief Executive Officer of MINDCURE.
Digital Platform iSTRYM Update
The Company released the minimum viable product ("MVP") of its digital therapeutics (DTx) technology, iSTRYM, into partner clinics across North America in August. MINDCURE is pleased to announce that it has exceeded its previously announced target and timeline of 10 clinics by the end of 2021. The Company has already partnered with 20 ketamine clinics in nine states in the US and three provinces in Canada and plans to expand to the broader mental health market in 2022.
In addition, MINDCURE will begin full commercial deployment to all partner clinics in early 2022, with expansion plans to the UK and Europe by the fourth quarter of 2022.
In addition to its recently announced letter of intent with Awakn Life Sciences Corp. to distribute their Ketamine for Alcohol Use Disorder ("AUD") protocol in North America via iSTRYM, MINDCURE will expand its selection of existing ketamine protocols with an additional MINDCURE developed protocol in the first quarter of 2022. The Company is continuing on its path toward becoming a leader in the distribution of best-in-class therapy protocols for both partners and providers.
Observational Study Update
MINDCURE is pleased to announce that its Integration Protocol Research Study is complete. As previously announced in March 2021, unconditional ethics approval from Veritas IRB was received for the study. The data has been amassed and findings incorporated into the MVP of iSTRYM. As a next step, the Company's research partners will submit findings for publication. Understanding integration protocols and practices is an important part of providing best-in-class care specific to psychedelic medicines in practice.
MINDCURE has further engaged Sandstone Media LLC ("Sandstone") to provide a broad range of product and brand awareness, marketing and media services, including message development, content creation, social media, advertising, marketing and retargeting, which may include related investor relations services. Sandstone will be paid up to USD$375,000 for the execution and management of the campaign.
Lastly, the Company has granted a total of 30,000 stock options to certain employees pursuant to the terms of the Company's long term incentive plan ("Plan"). The stock options are exercisable at a price of $0.33 per share and subject to the terms of the Plan.
Mind Cure Health ("MINDCURE") is a life sciences company focused on innovating and commercializing new ways to promote healing and improve mental health. The company is developing digital therapeutics technology and researching psychedelic compounds to support access to safe, evidence-based psychedelic-assisted therapies globally. Learn more at mindcure.com, and follow us on LinkedIn, Facebook, Twitter, and Instagram.
On Behalf of the Board of Directors
Kelsey Ramsden, President & CEO
Certain information presented in this news release may constitute "forward-looking information" within the meaning of applicable securities laws regarding MINDCURE and its business. Forward-looking information generally can be identified by the use of terms and phrases such as "anticipate", "believe", "could", "estimate", "expect", "feel", "intend", "may", "plan", "predict", "project", "subject to", "will", "would", and similar terms and phrases.
Forward-looking information is based on a number of key expectations and assumptions made by management of MINDCURE, including, without limitation: the COVID-19 pandemic impact on the Canadian economy and MINDCURE's business, and the extent and duration of such impact; no change to laws or regulations that negatively affect MINDCURE's business; the Company will develop its products as expected and that they will attain the outcomes anticipated; there will be a demand for MINDCURE's products in the future; no unanticipated expenses or costs arise; MINDCURE will be able to continue to identify products that make them ideal candidates for providing solutions for treating mental health; that strategic partnerships entered by the Company will create the opportunities and outcomes anticipated; that MINDCURE will advance wellness worldwide; that trading on the OTCQX will attract additional investment and provide additional liquidity for shareholders.
Forward-looking information is provided for the purpose of presenting information about management's current expectations and plans relating to the future and readers are cautioned that such statements may not be appropriate for other purposes. Forward-looking information inherently entails known and unknown risks and uncertainties about the future and actual results and involves significant risks and uncertainties and should not be read as a guarantee of future performance or results as actual results may differ materially from those expressed or implied in such forward-looking information. Those risks and uncertainties include, among other things, risks related to: successful clinical studies relating to ibogaine and the Desire Project, successfully synthesizing and manufacturing of ibogaine, the successful development, integration and deployment of iSTRYM, the successful development of appropriate Ketamine protocols, and acquiring adequate protection of any IP developed. Although MINDCURE has attempted to identify important factors that could cause actual results, performance or achievements to differ materially from those described in forward-looking information presented, there may be other factors that cause results, performance or achievements to differ from those anticipated, estimated or intended. Accordingly, readers should not place undue reliance on any forward-looking statements as no forward-looking information can be guaranteed.
Except as required by applicable securities laws, forward-looking statements speak only as of the date on which they are made and MINDCURE does not undertake any obligation to publicly update or revise any forward-looking information, whether as a result of new information, future events, or otherwise.
The CSE has neither approved nor disapproved the contents of this press release and the CSE does not accept responsibility for the adequacy or accuracy of this release.
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MINDCURE Investor Relations
Annie Graf / Kristin Cwalinski
KCSA Strategic Communications