Q1 2022 Highlights
- Delivered findings indicating psilocybin potentiates impact of anti-depressant
- Received positive feedback from pre-Investigational New Drug (“IND”) meeting with
U.S. Food and Drug Administration (“FDA”) on SANA-013 - Announced positive findings from Animal Study on Novel Depression Treatment Protocol Combining Psilocybin and Cannabidiol
- Record Q1 2022 operating results at
Wesana Clinics - Opening of third
Wesana Clinic inMay 2022 - Launched strategic Review of Care Delivery Assets
Select Consolidated Financial Information
The following table sets forth selected financial information derived from the Company’s unaudited interim combined and consolidated financial statements and notes thereto for the three-months ended
For the three months ended ($USD) | Change | |||
Cash Balance | 3,193,371 | 6,576,088 | (3,382,717 | ) |
Total Assets | 6,577,392 | 9,741,602 | (3,164,210 | ) |
Total Equity | 4,001,782 | 7,714,585 | (3,712,803 | ) |
Weighted Average Shares Outstanding | 33,312,555 | 23,152,729 | 10,159,826 | |
Fully Diluted Shares Outstanding (as converted*) | 41,593,023 | 41,387,743 | 205,280 |
*The number is presented assuming all of the Company’s outstanding Proportionate Subordinate Voting Shares and Super Voting Shares as at
Business Updates and Highlights
“We are delighted with our progress on SANA-013 and our accelerated pathway toward development,” said Wesana CEO and Chairman,
New Findings Indicating Psilocybin Potentiates Impact of an Anti-Depressant
On
Positive Feedback from Pre-IND Meeting with FDA on SANA-013
On
The Company received positive written responses from the FDA on
Positive Findings from Animal Study on Novel Depression Treatment Protocol Combining Psilocybin and Cannabidiol
On
Wesana’s novel and proprietary depression treatment protocol includes a single high dose of psilocybin followed by a maintenance regimen of a microdose of psilocybin combined with cannabidiol. In a validated pre-clinical animal model of depression, the maintenance regimen demonstrated up to 64% further improvement than those observed with a single high dose of psilocybin alone.
Furthermore, the maintenance regimen provided a sustained antidepressant effect after the single high dose of psilocybin. Wesana’s proprietary treatment protocol is currently being evaluated for the treatment of multiple mental health conditions including major depressive disorder associated with traumatic brain injury.
Strategic Rationale for Clinics and Other Care Delivery Asset Review:
Feedback from the FDA validates the Company’s strategic plan for simplification and growth. Given the clarity provided by FDA in the pre-IND meeting, and the Company’s increased focus on drug development, Wesana has commenced a strategic review of the Company’s assets with a focus on reviewing Wesana’s care delivery division. The Company is reviewing strategic alternatives including, but not limited to, a sale of all the assets under the care delivery division, including:
Wesana Clinics – a network of psychiatrist-led mental health clinics focused on serving the community through the delivery of personalized innovative psychiatric care, inclusive of ketamine therapy, medication management, psychotherapy, cognitive testing, and pharmacogenetic testing.- Wesana Solutions – a medical-grade clinical SaaS platform focused on improving mental healthcare through facilitating access to leading edge clinical protocols and tracking their efficacy. In concert with EMRs and practice management systems, Wesana Solutions is intended to be used in clinics delivering psychedelics and related therapies, targeting the developing international psychiatric clinic and research market.
- PsyTech Connect – a leading community for the clinical use of psychedelics with over 8,000 actively engaged professionals.
Management Changes
Wesana today announced that, as part of a Board of Directors transition,
"I am incredibly proud of the Company that we have built and the progress we have made to date," commented
Bronstein was instrumental in the founding of the Company as well as in its first years of growth. His commitment to Wesana over the past two years helped the Company go-public on the Canadian Securities Exchange and raise
"On behalf of everyone at Wesana, I would like to express my heartfelt gratitude to Chad for his support and guidance through Wesana's early growth. Chad was a visionary leader who provided excellent stewardship as we navigated the going-public and related capital raise process. As we position ourselves for our next phase of growth, we will continue on the path Chad and I set to develop and deliver life-changing medicine to those in need," said
About
Wesana Health helps people transcend barriers in mental health and performance. We innovate in care development through our therapies and patent-pending protocols, and in care delivery through activating a new multidisciplinary, technology-supported clinical model. Learn more at www.wesanahealth.com.
Investor Relations:
Email: IR@wesanahealth.com
Phone: 702-329-8038
Media Contacts:
Email: media@wesanahealth.com
Phone: 917-653-4613
Cautionary Note Regarding Forward-Looking Information
This news release contains “forward-looking information” within the meaning of applicable securities laws with respect to the Company, including, but not limited to: the initiation of Phase 1 clinical trials in late 2022, exploration of MDD as the lead indication for SANA-013, 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 estimates and assumptions of management at the date the statements are made.
Certain assumptions that influence successfully initiating its clinical development program in late 2022 include: (i) third parties who assisted the Company with the pre-IND submissions will continue to satisfy deadlines on deliverables within anticipated timeframes; (ii) the pre-IND guidance will continue to support that a drug development plan and future clinical trials are going to be acceptable to the FDA; (iii) the Company and its consultants can efficiently and timely address any additional correspondence, submission of additional materials or information pursuant to any ongoing requests as they may arise during the course of their review following the filing of submissions; (iv) additional pre-clinical studies will be commenced and completed on a timely basis and results will be supportive and as anticipated; (v) the Company’s pre-clinical studies (animal pharmacology and toxicology testing) generate data and analyses to support an FDA decision that it is safe to proceed with human trials of the Company’s formulation; and (vi) the Company is able to maintain a GMP supply source necessary to conduct in-human clinical trials.
Certain assumptions that influence successfully expanding the lead indication for SANA-013 to MDD include all of the assumptions in the above and (i) the board of directors of the Company (the “Board”) continues to determine and approve, based on the readiness of the overall research and development plan, capital resources and internal procedures of the Company, the expansion of the lead indication to MDD; (ii) the Company’s current capital will be sufficient for developing the updated IND submission package and updated IND enabling studies; (iii) the broadened indication and the future clinical trials are going to be acceptable to the FDA; (iv) the Company and its consultants can efficiently and timely address any additional correspondence, submission of additional materials or information pursuant to any ongoing requests as they may arise resulted from the broaden indication; and (v) additional pre-clinical studies required for MDD will be commenced and completed on a timely basis and results will be supportive and as anticipated.
Any patent efforts of the Company remain at the application stage and there is no assurance that the Company will file additional patent applications or in what jurisdictions they may be filed, if any. Furthermore, while the PCT application has been filed, there is no assurance that a patent(s) will be granted or will be granted in a form that will be sufficient to protect the Company’s proprietary therapies or protocols or enable it to gain or keep any competitive advantage that it may have.
Although management believes that the anticipated future results, performance or achievements expressed or implied by the forward-looking statements are based upon reasonable assumptions and expectations, the reader should not place undue reliance on forward-looking statements because they involve assumptions, known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements of the Company to differ materially from anticipated future results, performance or achievements expressed or implied by such forward-looking statements. Certain risk factors include but are not limited to there being no assurance as to the Company’s ability to continue as a going concern; there being no assurance that the strategic review of the Company’s care and delivery division will result in any viable alternatives or a definitive transaction; there being no assurance that the net proceeds of the recently completed private placement will be used as currently contemplated by the Company, the allocation and use of which is at the discretion of the Company, or that the Company will achieve the results from the use of such proceeds as currently targeted; the detrimental impact of future losses and negative cash flow from operations; requirements for additional capital; lack of product or service revenue; research and development of drugs targeting the central nervous system being particularly difficult; failure to comply with health and data protection 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; competition from other biotechnology and pharmaceutical companies; violations of laws and regulations resulting in repercussions; psychedelic inspired drugs possibly never being approved as medicines; regulatory or political change; reliance on third parties to plan, conduct and monitor preclinical studies and clinical trials; requirements of commercial scale and quality manufactured drug supply; negative results from pre-clinical and clinical trials or studies of others; unfavourable publicity or consumer perception; not achieving publicly announced milestones; 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; general economic, market and business conditions and other risk factors including those found in the MD&A and the Company’s annual information form dated
Forward-looking information is provided and made as of the date of this news release and the Company does not undertake any obligation to revise or update any forward-looking information other than as required by applicable law.
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