Q4 2021 Highlights and Subsequent Events
- Exploring broadening SANA-013’s lead indication to treat Major Depressive Disorder (“MDD”)
- Delivered findings indicating that psilocybin potentiates the impact of an anti-depressant
- Received positive feedback from pre-IND meeting with FDA on SANA-013
- Reported positive findings from animal study on novel depression treatment protocol combining psilocybin and cannabidiol
- Appointed Meghna A. Gaeta as Chief Marketing Officer
- Completed filing of Patent Cooperation Treaty (“PCT”) Applications for novel drug protocols
- Record Q4 2021 and Q1 2022 operating results at Wesana Clinics
- Third Wesana Clinic slated to open May 2022
- Ended the fourth quarter with US $6.6 million in cash
Daniel Carcillo, Chief Executive Officer of Wesana Health, commented: “The fourth quarter of 2021 and events subsequent to the quarter-end, marked a number of important strategic developments for Wesana Health culminating with the positive feedback from FDA regarding SANA-013 and our strategic decision to explore broadening the lead indication of SANA-013 to MDD. In addition, we are pleased to report that our Care Delivery business segment, Wesana Clinics (the “Clinics”), experienced record-breaking growth in the fourth quarter and subsequently in the first quarter of 2022.
We expect that our ongoing strategic investments in people, assets and capabilities will continue to deliver value to our current and future patients in addition to our broader stakeholders.”
Selected Consolidated Financial Information
The following table sets forth selected financial information derived from the Company’s annual combined and consolidated financial statements for the years ended December 31, 2021 and 2020. 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.
*The number is presented assuming all of the Company’s outstanding Proportionate Subordinate Voting Shares and Super Voting Shares as at December 31, 2021 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 December 31, 2021 are converted, exchanged or exercised in accordance with their terms.
Business Updates and Highlights
“We are delighted with the progress we have made thus far on SANA-013 and the clear pathway set forth by FDA for the initiation of study in humans,” said Mark Wingertzahn, Wesana Chief Scientific Officer. “As we look into optimizing our drug development program, we are moving forward concurrently with our functional animal studies to broaden and deepen our knowledge of SANA-013.”
Wesana Is Exploring Broadening SANA-013 Lead Indication to Treat Major Depressive Disorder
On April 18, 2022, following the completion of a successful Pre-IND meeting with the United States Food and Drug Administration (“FDA”), the Company announced it is exploring the opportunity to expand its lead indication for SANA-013 to Major Depressive Disorder (“MDD”) following the completion by the Company of the non-brokered private placement (the “Placement”).
Consistent with the positive feedback received from the FDA, Wesana is also exploring the opportunity to accelerate the development of SANA-013 by initiating a Phase 1b/2a human study for MDD in H1 2023. In contrast to the current development pathway for SANA-013 with TBI associated depression as the lead indication, currently targeting the launch of a Phase 1 study in Q4 of 2022 in a healthy human patient population, the revised development pathway would allow the Company to bypass the healthy patient population study and research an MDD affected patient population directly as part of a Phase 1b/2a study.
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 that they have received a full written response from the FDA regarding their pre-Investigational New Drug (“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 Company believes the written response provides a path to agreements on IND-enabling studies and validates the team’s effort and accomplishments over the past year. 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.
PCT Patent Applications for Novel Drug Protocols
On December 9, 2021, Wesana announced the completion of PCT applications toward securing the exclusive rights to protocols, delivery methods and compositions of matter which includes utilizing a high loading dose of psilocybin-assisted psychotherapy, coupled with non-hallucinogenic, low maintenance doses of psilocybin with and without other evidence-based therapies (plant medicines, fungi and adaptogens) to treat neurological based conditions. These PCT applications, filed with the World Intellectual Property Organization, will enable Wesana to file patent applications and seek protection in most major markets throughout the world.
Clinics and Financing Update
Medical billings1 from Wesana Clinics increased 30% in the first quarter of 2022 as compared to the fourth quarter of 2021. In that same period, overall patient volume increased by 4%, led by 95% increase in Spravato appointments.
Wesana is also thrilled to announce the official May 2022 opening of their third facility in Naperville, Illinois. Naperville’s convenient location will complement the existing Wesana Clinics locations in Oak Brook and Chicago, enabling the Clinics to provide high caliber mental healthcare to the growing number of residents in the western suburbs and greater Chicagoland area.
This new 3,000 square-foot facility – located in southwest Naperville – will be overseen by Dr. Abid Nazeer, Naperville native and Wesana’s Chief Medical Officer. The psychiatrist-led clinic will focus on serving the community through the delivery of personalized innovative psychiatric care, inclusive of ketamine therapy, medication management, psychotherapy, cognitive testing, and pharmacogenetic testing. It will also be the first of the Wesana Clinics to offer Deep Transcranial Magnetic Stimulation, which has shown efficacy as a treatment for conditions such as Major Depression, OCD, anxious depression, and more.
Wesana today announced that it has closed an initial tranche of the previously announced non-brokered private placement for aggregate gross proceeds of approximately CAD$1,100,000. The Company intends to use the net proceeds from the Placement towards evaluating the potential expanding of the indication for SANA-013 to MDD and initiating a Phase 1b/2a human study in H1 2023 as an alternative approach to the current development pathway, research and development activities following such evaluation and general working capital and corporate purposes.
Pursuant to the initial tranche of the Placement, the Company issued 641,154 Subordinate Voting Share Units (each, an “SVS Unit”) at a price of CAD$0.73 per unit and 17,158 Proportionate Subordinate Voting Share Units (each, a “PVS Unit”) at a price of CAD$36.50 per unit. Each SVS Unit consists of one Subordinate Voting Share and one Subordinate Voting Share purchase warrant (an “SVS Warrant”). Each SVS Warrant is exercisable by the holder thereof to acquire one additional Subordinate Voting Share for a period of 36 months from the date of issue at an exercise price of CAD$0.90 per Subordinate Voting Share. Each PVS Unit consists of one Proportionate Subordinate Voting Share and one Proportionate Subordinate Voting Share purchase warrant (a “PVS Warrant”). Each PVS Warrant is exercisable by the holder thereof to acquire one additional Proportionate Subordinate Voting Share for a period of 36 months from the date of issue at an exercise price of CAD$45.00 per Proportionate Subordinate Voting Share. No subscriptions under the initial tranche of the Placement are subject to finder’s fee.
Securities issued under the Placement are subject to a four-month hold period under applicable Canadian securities laws.
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 Q4 2022, exploration of initiation of a Phase 1b/2a study in H1 2023 as part of a revised accelerated development pathway, exploration of MDD as the lead indication for SANA-013, the use of proceeds of the Placement, the Company’s patent application efforts, information concerning timing for the opening of Wesana’s new clinic located in Naperville, Illinois, 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 Q4 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”) makes a determination, based on the readiness of the overall research and development plan, capital resources and internal procedures of the Company, to approve the expansion of the lead indication to MDD; (ii) the Company’s current capital and proceeds from the Placement 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.
Certain assumptions that influence the successful initiation of a Phase 1b/2a study in H1 2023 as part of a revised accelerated development pathway include: all assumptions above and (i) the Company’s current capital and proceeds from the Placement will be sufficient for the accelerated study; and (ii) the Board makes a determination, based on the readiness of the overall research and development plan, capital resources and internal procedures of the Company, to approve the revised project objectives.
Certain factors that influence the successfully opening of the Naperville clinic in Q2 2022/Spring 2022 include: (i) the Company has finalized the lease, (ii) renovations and permitting of the property for the purpose of clinic operations have been, and are expected to continue to be, minimal, (iii) the Company has an internal and external team dedicated to addressing issues that may arise during clinic construction; and (iv) there have been no significant delays in the final preparation of the clinic or staffing plans. The timeline for the opening of the third clinic was revised to Q2 2022/Spring 2022 to reflect the delays caused as a result of shipment delays for various furniture and fixtures to be delivered to the third clinic for use in the operations.
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 net proceeds of the 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; there being no assurance that a further tranche of the Placement will be completed, and if completed, as to the size thereof; 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.
1 Medical billings is a non-GAAP measure, which includes service fees submitted for payment which are adjusted by the insurance providers based on underlying factors, such as insurance plan, services rendered, and patient deductible limits.