Wesana Health Holdings Inc. (CSE: WESA; OTCQB: WSNAF), a data-driven life sciences company focused on developing the novel therapies of tomorrow and delivering new care paradigms, is pleased to announce that following the completion of a successful Pre-IND meeting with the United States Food and Drug Administration, the Company is exploring the opportunity to expand its lead indication for SANA-013 to Major Depressive Disorder following the completion by the Company of a non-brokered private 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 anxiety 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.
‘Given the positive feedback from FDA regarding SANA-013, there is an opportunity for Wesana to optimize the drug development program to focus on the broadest indication for our novel formulation and protocol and to de-risk future clinical development.’Daniel Carcillo, Wesana’s founder and Chief Executive Officer
MDD is a chronic, recurring, and debilitating mental disorder leading it to be one of the most burdensome illnesses on a global scale. Patients suffering from MDD are frequently and significantly impaired from an occupational and social function standpoint resulting in severe economic costs. With approximately 264 million people suffering from depression globally, according to World Health Organization data in 2020, the market size is currently estimated to grow at a CAGR of 3.9% to US$16 billion by 2026.1
Mark Wingertzahn, Wesana’s Chief Scientific Officer, said, ‘Pursuing an indication such as MDD will allow for a streamlined development path with the opportunity, if successful, to help millions of people worldwide.’
Non-Brokered Private Placement
In connection with the above, the Company announces that it is proceeding on a non-brokered private placement financing for gross proceeds of up to USD$3,000,000. The Company intends to use the proceeds from the Placement towards evaluating expanding 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 Placement, the Company is offering Subordinate Voting Share Units (each, an ‘SVS Unit’) at a price of CAD$0.73 per unit and Multiple Voting Share Units (each, an ‘MVS Unit’) at a price of CAD$36.50 per unit. Each SVS Unit will consist of one Subordinate Voting Share of the Company (an ‘SVS’) and one Subordinate Voting Share purchase warrant (an ‘SVS Warrant’). Each SVS Warrant will be exercisable by the holder thereof to acquire one additional SVS for a period of 36 months from the date of issue at an exercise price of CAD$0.90 per SVS. Each MVS Unit will consist of one Multiple Voting Share of the Company (an ‘MVS’) and one Multiple Voting Share purchase warrant (an ‘MVS Warrant’). Each MVS Warrant will be exercisable by the holder thereof to acquire one additional MVS for a period of 36 months from the date of issue at an exercise price of CAD$45.00 per MVS.
Certain subscriptions under the Placement may be subject to finder’s fees. The Placement may be closed in multiple tranches and is not subject to a minimum offering. Securities issued under the Placement will be subject to a four-month hold period under applicable Canadian securities laws. The Placement is subject to certain conditions including compliance with the rules and policies of the Canadian Securities Exchange.
This news release does not constitute an offer to sell or a solicitation of an offer to buy any securities in the United States or any other jurisdiction in which such offer, solicitation or sale would be unlawful. No securities may be offered or sold in the United States or in any other jurisdiction in which such offer or sale would be unlawful absent registration under the United States Securities Act of 1933, as amended, or an exemption therefrom or qualification under the securities laws of such other jurisdiction or an exemption therefrom.
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.