Wesana Health Announces Positive Feedback From Pre-IND Meeting With FDA on SANA-013
Pre-IND Meeting is a Significant Milestone in the Clinical Development of SANA-013, Defining the Pathway…
Science has hardly scratched the surface of the true potential of psychedelic compounds. At Wesana, we are redesigning the future of psychedelic medicine with SANA-013.
“We are having a second generation of psychedelic research & development for mental healthcare.”
Mark Wingertzahn, PhD.
Chief Science Officer, Wesana Health
By utilizing psilocybin and cannabidiol (CBD), a combination therapy of compounds with demonstrated effectiveness, SANA-013, is targeted for the treatment of Traumatic Brain Injury (TBI) related major depressive disorder (MDD), migraine, and anxiety.
In contrast to therapist assisted, single dose therapy, where a large dose of psilocybin is administered in clinic, which has exhibited poor durability and waning effects beginning as early as a few weeks post administration, SANA-013 utilizes a loading dose of psilocybin followed by self-administered maintenance doses of psilocybin and CBD to provide more sustained effects and benefit over time.
SANA-013 is covered under patent applications owned by Wesana and directed to novel composition and novel methods of use.
*Phase I study results will support moving directly into efficacy studies across three separate indications with different dosing regimens.
See “Disclaimer” for notes regarding third-party information and forward-looking information and statements
Clinical psychedelic treatment holds limitless potential to help people suffering from mental health challenges. Wesana has assembled a world class team to unlock the true potential of these medicines and the human brain.
Expert practitioners establish and refine best practices
Wesana’s approach to developing combination Wesana applies its knowledge to emerging psychedelic therapies like Psilocybin
Industry-leading remote patient monitoring gathers data on safety and efficacy
Pre-IND Meeting is a Significant Milestone in the Clinical Development of SANA-013, Defining the Pathway…
Wesana’s novel and proprietary depression treatment protocol that includes a single high dose of psilocybin…
The meeting is scheduled for March 11, 2022 CHICAGO and TORONTO, Jan. 11, 2022 (GLOBE…
Pre-IND Meeting is a Significant Milestone in the Clinical Development of SANA-013, Defining the Pathway to Initiate in-Human
Wesana’s novel and proprietary depression treatment protocol that includes a single high dose of psilocybin followed by a
The meeting is scheduled for March 11, 2022 CHICAGO and TORONTO, Jan. 11, 2022 (GLOBE NEWSWIRE) — Wesana Health
The information contained in this presentation has been prepared by Wesana Health Holdings Inc. (“Wesana” or the “Company”) and contains information pertaining to the business, operations, and prospects of the Company. The information contained in this presentation is provided as at the date hereof, unless otherwise stated, and is subject to change without notice, and does not purport to contain all the information that may be necessary or desirable to fully and accurately evaluate an investment in the Company. This presentation is for informational purposes only and should not be considered a recommendation to purchase, sell or hold a security of the Company. This presentation does not constitute an offering memorandum or an offer or solicitation in any province or territory of Canada or other jurisdiction. Other than as may be required by applicable laws, the Company is under no obligation to update any information included in this presentation.
The Company takes no responsibility for, and provides no assurance as to the reliability of, any information that others may give readers of this presentation. No securities regulatory authority has expressed an opinion about the securities of Wesana and it is an offense to claim otherwise.
An investment in the securities of the Company is speculative and involves a number of risks. Readers should refer to the annual information form of the Company dated September 3, 2021 (the “AIF”), the unaudited interim financial statements of the Company as at and for the three and nine-months ended September 30, 2021 and 2020, the management’s discussion and analysis of the Company for the three and nine-months ended September 30, 2021 (the “Interim MD&A”), and the Company’s other public filings available on the Company’s profile on SEDAR at www.sedar.com for further information as to the Company, including risk factors relating to the business and securities of the Company.
This presentation includes market and industry data which was obtained from various publicly available sources and other sources believed by Wesana to be true. Although Wesana believes it to be reliable, Wesana has not independently verified any of the data from third-party sources referred to in this presentation or analyzed or verified the underlying reports relied upon or referred to by such sources, or ascertained the underlying assumptions relied upon by such sources. Wesana does not make any representation as to the accuracy of such information.
THIRD PARTY INFORMATION
This presentation includes market and industry data which, unless otherwise indicated, was obtained from various publicly available sources and other sources believed by Wesana to generally be reliable. Although Wesana believes it to be generally reliable, market and industry data is subject to interpretation and cannot be verified with complete certainty due to limits on the availability and reliability of raw data, the voluntary nature of the data gathering process and other limitations, assumptions and uncertainties inherent in any survey and Wesana has not independently verified any of the data from third-party sources referred to in this presentation or analyzed or verified the underlying reports relied upon or referred to by such sources, or ascertained the underlying assumptions relied upon by such sources. Wesana does not make any representation as to the accuracy of such information.
FORWARD-LOOKING INFORMATION AND STATEMENTS
This presentation contains “forward-looking information” within the meaning of applicable securities laws with respect to the Company, including, but not limited to: the beta testing results for, the completion of product development and timing for clinic deployment of, Wesana Solutions, the opening of further Wesana Clinics, the completion and timing of completion of certain aspects of the Company’s drug development initiatives, the completion and timing of entering into a partnership with MAPS
and information concerning the expected benefits thereof, and any other statement that may predict, forecast, indicate or imply future plans, intentions, levels of activity, results, financial position, operational or financial performance or achievements. Often, but not always, forward-looking information can be identified by the use of words such as “plans”, “expects”, “is expected”, “budget”, “scheduled”, “estimates”, “forecasts”, “intends”, “anticipates”, “will”, “projects”, or “believes” or variations (including negative variations) of such words and phrases, or statements that certain actions, events, results or conditions “may”, “could”, “would”, “might” or “will” be taken, occur or be achieved. Except for statements of historical fact, information contained herein constitutes forward-looking information.
Forward-looking information is not a guarantee of future performance and is based upon a number of factors and assumptions of management and is subject to a number of risks at the date the statements are made. Please refer to the Interim MD&A and the AIF for, among other things, further details as certain of such factors, assumptions and risks. Further details as to the status of Wesana’s drug development initiatives are also found in the Interim MD&A.
Wesana Solutions remains in the beta testing phase. While there is no assurance that product development will be completed and clinical deployment will be achieved nor the extent to which the Company will secure clinical customers for Wesana Solutions once it completes product development and initiates the clinical deployment, the clinic deployment of Wesana Solutions is contemplated to begin in the first quarter of 2022. Certain factors that influence successfully completing beta testing and product development and achieving clinical deployment within such timeline include: (i) the development of this software platform was subcontracted out by the Company and the beta testing phase has been initiated; (ii) third parties and internal product leads have met expected deliverable timelines to date; (iii) to date the Company has not identified any significant issues regarding functionality of the software; (iv) the Company has allocated sufficient funds and resources to complete final product development and marketing plans; and (v) the Company has engaged regulatory and data consultants to monitor regulations impacting commercialization of the software.
Certain assumptions that influence successfully completing beta testing and product development and achieving clinical deployment within such timeline include: (i) there are no significant delays in the final development and testing schedule and staffing plans;
(ii) beta testing results are positive and supportive of the software being deployed in a clinical setting; (iii) development and marketing costs remaining consistent with the Company’s budgeting; and (iv) the Company will be able to secure future relationships and establish commercial agreements for the software with third party clinics.
Certain factors that influence successfully opening a third Wesana Clinic in the first quarter of 2022 include: (i) the Company has identified a third clinic location and property and is currently in lease negotiations; (ii) should the Company procure additional capital and proceed with a lease in connection with the identified third property, renovations and permitting of the property for the purpose of clinic operations are expected to be minimal; (iii) the Company has an internal team dedicated to identifying potential target clinics and locations and evaluating and addressing issues that may arise during due diligence of any potential targets.
Certain assumptions that influence successfully opening a third Wesana Clinic in the first quarter of 2022 include: (i) there are no significant delays in executing the third property lease in the fourth quarter of 2021 or shortly thereafter, if additional capital is raised; (ii) additional capital is raised during the fourth quarter of 2021 or shortly thereafter for the third location; and (iii) there are no significant delays in renovation/permitting if the third property lease is executed.
The formation of a partnership between the Company and MAPS remains at a preliminary stage. Certain assumptions that influence successfully forming such a partnership include: (i) the ability of the Company to successfully negotiate and enter into definitive documentation in respect of the contemplated partnership with MAPS and satisfy any related conditions precedent; and (ii) the ability of the Company to raise sufficient additional capital to be able to fund such potential partnership with MAPS. Other general assumptions include, operating conditions remaining favorable, including sustained availability of third-party service providers and other inputs for the Company’s operations; sustained political and regulatory stability; and sustained stability in capital goods markets.
While the Company considers the foregoing assumptions to be reasonable, the assumptions are inherently subject to significant business, economic, social, political, regulatory, competitive, and other risks and uncertainties, contingencies and other factors that could cause actual performance, achievements, actions, events, results or conditions to be materially different from those projected in the forward-looking information. Many assumptions are based on factors and events that are not within the control of the Company and there is no assurance they will prove to be correct.
Furthermore, such forward-looking information involves known and unknown risks, uncertainties and other factors which may cause the actual performance, achievements, actions, events, results, or conditions of the Company to be materially different from any future performance, achievements, actions, events, results or conditions expressed or implied by such forward-looking information. Such factors include, among others: delays in beta clinical testing resulting in delays in commercializing; the Company does not remain within its development and marketing costs for Wesana Solutions, requiring the Company to reallocate existing capital away from other projects and/or raise additional capital; reliance on third parties to plan, conduct and monitor beta clinical testing, product development and clinical deployment of technology; the Company does not secure future relationships and establish commercial agreements for Wesana Solutions with third party clinics; inability to raise sufficient additional capital to fund the opening of the third Wesana Clinic; inability to receive any applicable governmental approvals and permits to advance the business of the Company, including to open the third Wesana Clinic, should additional capital to fund its opening be raised; inability to negotiate, settle, enter into or execute upon a definitive partnership arrangement with MAPS; inability to raise sufficient additional capital to fund such potential partnership with MAPS; research and development of drugs targeting the central nervous system being particularly difficult; failure to comply with health and data protection laws and regulations; violations of laws and regulations resulting in repercussions; regulatory or political change; changes to applicable corporate practice of medicine laws and regulations; delays in pre-clinical and clinical testing resulting in delays in commercializing; inability to file investigational new drug applications or clinical trial applications to commence clinical trials in a timely manner; difficulty enrolling patients in clinical trials; reliance on third parties to plan, conduct and monitor preclinical studies and clinical trials; competition from other biotechnology and pharmaceutical companies; maintaining and enhancing reputation and brand recognition; ability to protect intellectual property; requirements to share intellectual property with service providers; negative operating cash flow and going concern; the detrimental impact of future losses and negative cash flow from operations; unfavorable publicity or consumer perception; not achieving publicly announced milestones; psychedelic inspired drugs possibly never being approved as medicines; reliance on the capabilities and experience of key executives and scientists; disruptions due to acquisitions or collaborations; risk of product liability claims; COVID-19; litigation; conflicts of interest; limited operating history; exposure to the fluctuation of foreign exchange rates; enforcement of judgments and effecting service of process on directors and officers; general economic, market and business conditions, and other risks factors including those found in the Interim MD&A and the AIF filed on the Company’s profile on SEDAR at www.sedar.com and discussed in the Company’s other public filings available on SEDAR.
Although the Company has attempted to identify important factors that could cause actual results to differ materially, there may be other factors that cause results not to be as anticipated, estimated or intended. There can be no assurance that such forward- looking information will prove to be accurate as actual results and future events could differ materially from those anticipated in such information. Accordingly, readers should not place undue reliance on forward-looking information. Forward- looking information is provided and made as of the date of this presentation and the Company does not undertake any obligation to revise or update any forward-looking information other than as required by applicable law.