Wesana continues to move forward with its strategy of optimizing operations in spaces that will contribute maximum to shareholder value. Despite a challenging macroeconomic environment for biotech companies, we have made significant progress in our clinical program for SANA-013. , the positive recommendation obtained from the FDA led our team to expand our number one indication for primary depressive disorder, an indication that affects approximately 264 million people worldwide¹.
We have achieved significant milestones in our preclinical program, adding positive effects from animal studies that support our IND application. In addition, we have finished a new animal that demonstrates that psilocybin has the ability to potentiate the effects of antidepressant medications. Based on feedback from regulators, we have made the strategic decision to advance our clinical program for SANA-013 and launch a Phase 1b/2a human in the first half of 2023, subject to capital availability.
I am incredibly proud of our team and the efforts being made to bring SANA-013 to a clinical level where it can be administered in a human population for clinical work. The initiation of the Phase 1b/2a examination will be a focal point for SANA-013 as we gather knowledge that may be our number one indication for primary depressive disorder in addition to possible long-term indications for SANA-013 that would possibly gain advantages for patients. We remain convinced that our new protocol, if approved through the FDA, has the potential to replace the lives of millions of other people suffering from depression.
As part of our increased focus on the drug development program, we have taken steps to optimize our operational design through strategic reorganization and downsizing. The restructuring program reduced control levels, eliminated duplicate roles, and outsourced some roles to optimize costs. The overall restructuring program reduced the company’s annual expenses by approximately $2. 1 million, not including severance pay and related costs. While the resolution to get rid of a significant portion of our workforce was complicated, our new operational design allows Wesana to be a stronger, more sustainable and targeted company. .
Finally, to complete our transition to a simplified operating structure, we have introduced a strategic review of our care delivery assets, Wesana Clinics, Wesana Solutions and Psytech Connect.
While we continue to consider the long-term price of those assets and are pleased with their progression and growth, our team remains of the view that an optimized strategy aimed at drug progression will produce the most productive returns on shareholder price over the long term. In addition, we believe that any long-term capital deployment, adding up the proceeds from any sale of Care Delivery’s assets, will be further invested in SANA-013.
We are encouraged by the point of interest earned in Care Delivery’s assets and while there is no certainty lately whether a transaction will be completed, we look forward to the prospect of completing a sale or other transaction to perform with respect to those assets. . .
While broader capital markets remain a challenge for startups, we are working diligently to maximize the price of our existing assets for our shareholder base. the long term of wesana, as we consider starting the first phase of SANA-013. Our current positioning builds on the multitude of successes our team has achieved in 2021 and the first part of 2022, which we intend to leverage for long-term growth. .
Daniel CarcilloHead of Management, Wesana Health Holdings Inc.
¹ World Health Organization, 2020
About Wesana Health
Wesana Health is helping others overcome barriers when it comes to fitness and intellectual performance. We innovate in the progression of care through our patent-pending treatments and protocols, and in the delivery of care through the activation of a new multidisciplinary clinical style supported through technology. Learn more about www. wesanafitness. com.
Cautionary Note Regarding Forward-Looking Information
This news release “forward-looking data” within the meaning of applicable securities legislation with respect to the Company, including, but not limited to: commencement of a Phase 1b/2a examination in the first half of 2023 under a revised accelerated progression trajectory; MDD scan as number one indication for SANA-013; data relating to the timing or finishing touch of any disposition or other transaction involving Care Delivery assets, if any; the final touch of any transaction related to Care Delivery assets; and any other statement that may predict, forecast, signify or signify long-term plans, intentions, degrees of activity, effects, monetary condition, operational or monetary functionality or achievements. Often, but not always, forward-looking data can be learned by using words such as “plans”, “expects”, “is planned”, “budget”, “expected”, “estimates”, “forecasts”. “, “intends”, “anticipates”, “will”, “projects” or “believes” or variations (including negative variations) of those words and phrases, or statements that certain actions, events, effects or situations “possibly” , “could”, “might”, “could” or “will” be taken, will happen or be made. Except for statements of past fact, the data contained in this document constitutes forward-looking data, does not guarantee long-term functionality, and is based on a series of control estimates and assumptions at the date on which the statements are made.
Certain assumptions influencing the successful launch of a Phase 1b/2a study in the first part of 2023 as part of a revised accelerated progression trajectory come with the Fact that the Company’s capital will be sufficient for the accelerated study; and the availability of the Corporation’s general studies and progression plan, capital resources and internal procedures justify the pursuit of the revised allocation objectives. There can be no guarantee that divestitures of any component or other transaction related to Care Delivery’s assets will be completed, and The Company does not intend to make additional comments on the procedure unless and until its Board of Directors has decided that further disclosure is appropriate or required by law. In addition, there can be no guarantee that a transaction involving Care Delivery’s assets will occur in a manner sufficient to meet the Company’s capital wishes or to enable it to earn or maintain any competitive merit it may have in the drug business.
Although the control believes that the expected long-term effects, functionality or achievements expressed or implied through the forward-looking statements are disclosed in conservative assumptions and expectations, the reader deserves not to place undue reliance on the forward-looking statements because they imply assumptions, Known and unknown threats. Matrix uncertainties and other items that could possibly cause the Company’s actual effects, performance or achievements to differ materially from the expected long-term effects, performance or achievements expressed or implied by such forward-looking statements. Certain threat items include, but are not limited to, uncertainty as to the Company’s ability to continue as a going concern; there can be no guarantee that the strategic review of the Company’s care delivery assets will result in viable opportunities or a definitive transaction; There can be no guarantee that the net income from the recently completed personal position will be used as recently weighted through the Company, the allocation and use of which are at the discretion of the Company, or that the Company will discharge the effects of the use thereof. lately targeted products; the adverse impact on long-term losses and negative operating cash flow; other capital needs; lack of earnings from products or services; studies and progression of drugs targeting the central nervous system formula are particularly difficult; non-compliance with knowledge and aptitude coverage laws and regulations; delays in preclinical and clinical trials causing delays in advertising; failure to register investigational new drug applications or clinical trial applications to start clinical trials in a timely manner; difficulty recruiting patients into clinical trials; festival of other biotechnological and pharmaceutical companies; violations of laws and regulations resulting in repercussions; psychedelic-inspired drugs that may never have been approved as medicine; regulatory or policy change; the use of third parties to plan, conduct and monitor preclinical studies and clinical trials; advertising scale needs and source of quality manufactured drugs; negative effects from preclinical and clinical trials or third party studies; adverse exposure or client perception; failing to achieve publicly announced milestones; confidence in the roles and experience of key executives and scientists; interruptions due to acquisitions or collaborations; threat of product liskill claims; COVID-19 [FEMALE; dispute; conflicts of interest; limited operating history; general economic, market position and business situations and other threat points, adding those disclosed in the MD&A and the Company’s Annual Information Form dated September 3, 2021 recorded in the Company’s prior filing on SEDAR at www. sedar. com and discussed in the Company’s other public filings available on SEDAR.
Forward-looking data is provided and written as of the date of this publication and the Company assumes no legal responsibility to revise or update prospective data except to the extent required by applicable law.
Investor Relations: Keenan Gentry Email: IR@wesanahealth. com Phone: 702-329-8038
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