CHICAGO and TORONTO, May 31, 2022 (GLOBE NEWSWIRE) — Wesana Health Holdings Inc. (“Wesana” or the “Company”) (CSE: WESA; OTCQB: WSNAF), a data-driven life sciences company focused on developing the novel therapies of tomorrow and delivering new care paradigms today, has today announced its first quarter 2022 financial results.
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 in May 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 March 31, 2022. The following information should be read in conjunction with the financial statements and the accompanying management’s discussion and analysis (“MD&A”), which are available on the Company’s website at www.wesanahealth.com and under the Company’s SEDAR profile at www.sedar.com.
|For the three months ended ($USD)||Mar 31, 2022||Dec 31, 2021||Change|
|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 March 31, 2022 are converted into Subordinate Voting Shares in accordance with their terms and all of the Company’s other outstanding convertible, exchangeable and exercisable securities as at March 31, 2022 are converted, exchanged or exercised in accordance with their terms.
Business Updates and Highlights
“We are delighted with our progress on SANA-013 and our accelerated pathway toward development,” said Wesana CEO and Chairman, Daniel Carcillo. “Our shift in focus to our drug development program will be instrumental in working toward the Company’s goal of FDA approval for SANA-013.”
New Findings Indicating Psilocybin Potentiates Impact of an Anti-Depressant
On March 22, 2022, Wesana delivered data from an animal study, conducted by an independent global laboratory services provider in a validated model of depression. Results of the study showed that administration of imipramine given three weeks following a psilocybin loading dose provided an additional 39% improvement in depressive behaviors from that of psilocybin loading dose alone. Furthermore, a second administration of imipramine given four weeks after a psilocybin loading dose provided an even greater reduction (45%) in depressive behaviors.
Positive Feedback from Pre-IND Meeting with FDA on SANA-013
On March 14, 2022, Wesana reported it received a full written response from the FDA regarding their pre-IND meeting for the novel therapy and proprietary protocol of SANA-013 for the treatment of Traumatic Brain Injury (“TBI”) related MDD.
The Company received positive written responses from the FDA on March 11th outlining the requirements to open the IND and commence clinical studies for SANA-013. The written response provides a path to agreements on IND-enabling studies and validates the team’s recent effort and accomplishments. The FDA response also provided important insights pertaining to advancing SANA-013 as a potential treatment for TBI-related MDD. Wesana intends to initiate its in-human clinical study program in late 2022.
Positive Findings from Animal Study on Novel Depression Treatment Protocol Combining Psilocybin and Cannabidiol
On January 18, 2022, Wesana shared positive results of an animal study on a novel depression treatment protocol. Combining psilocybin and cannabidiol, the animal study, conducted by an independent global laboratory services provider, demonstrated considerable and sustained improvement in depressive behaviors.
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.
Wesana today announced that, as part of a Board of Directors transition, Chad Bronstein has tendered his resignation as Executive Chairman, effective immediately, to pursue other professional opportunities. In connection with Mr. Bronstein’s resignation, the Company is pleased to announce the Company’s Board of Directors’ appointment of Daniel Carcillo as Chairman.
“I am incredibly proud of the Company that we have built and the progress we have made to date,” commented Mr. Bronstein, “and I look forward to seeing the continued evolution of Wesana under Daniel’s leadership as the Company moves towards advancing its clinical development program and human clinical trials in the coming months later this year.”
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 $17 million in capital, to initiate the FDA drug development and approval process.
“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 Daniel Carcillo, Wesana’s Founder and CEO.
About Wesana Health
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.
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 September 3, 2021 filed on the Company’s profile on SEDAR at www.sedar.com and discussed in the Company’s other public filings available on SEDAR.
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.
Source: Wesana Health
Released May 31, 2022