Skye Bioscience Inc (OTCQB:SKYE) announced that it has concluded the merger with Emerald Health Therapeutics after both companies' shareholders voted in favor and the Supreme Court of British Columbia approved the transaction.
As of the date of closing, Skye has entered into agreements to divest certain remaining cannabis assets and licenses, including the Quebec cannabis production facility.
The company also unveiled its plans for the remainder of 2022 and 2023.
READ: Skye Bioscience completes drug production for phase one clinical study using synthetic cannabinoids to treat glaucoma
Punit Dhillon, CEO and chair of Skye said: "Completing this merger provides Skye with additional capital to advance its first clinical trials of SBI-100 Ophthalmic Emulsion, starting with our Phase 1 study, for which we expect to begin recruiting the first cohort of subjects shortly, as well as our Phase II study, for which we expect to file our Investigational New Drug application with the FDA by year-end.
"I thank the shareholders of both Emerald and Skye for supporting this transaction. I also want to express the greatest appreciation to Jim Heppell, Emerald's Chairman, and Mohammed Jiwan, COO, for their stewardship of Emerald and focused effort to conclude Emerald's orderly pivot out of the Canadian cannabis industry and move this transaction to fruition.
"I welcome all Emerald shareholders as new Skye stockholders and want to emphasize to both our previously existing and new stockholders that we are wholeheartedly committed to building value through the discovery and validation of distinct therapeutic molecules and will do our best to achieve this goal."
Listing on CSE
Although the conditional listing requirement has been waived, Skye has covenanted that it will use its best efforts to obtain the listing of its shares on the CSE as soon as possible. The Skye listing application was submitted to the CSE on August 31, 2022 and is currently under review.
New board of directors
Post-closing, Skye's Board of Directors comprises the existing directors including Punit Dhillon, chair, Margaret Dalesandro, Praveen Tyle, and Keith W. Ward, the latter three all possessing extensive experience in the ocular drug space.
Newly appointed to Skye's board is Bobby Sukhwinder Rai, BSc. Biochem., BSc. Pharm., RPh., who was a member of Emerald's Board of Directors. Rai has over 20 years of experience operating "The Medicine Shoppe" Pharmacies in Greater Vancouver, Canada.
In 1998, he and his partners pioneered the online pharmacy business in the USA. Rai introduced HIV point-of-care testing into community pharmacies and introduced lab testing to pharmacies, including chronic kidney disease screening using the HealthTab technology. Both were firsts in Canada.
Rai is a member of the Alumni UBC Advisory Council representing the Faculty of Pharmaceutical Science. He is also Chairman and CEO of Canadian Pacific Global Pharmaceuticals and Chairman of its subsidiary PharmaCanada Inc.
Skye's executive team remains unchanged, consisting of Punit Dhillon, Chief Executive Officer, Kaitlyn Arsenault, CPA, Chief Financial Officer, and Tu Diep, MSc, Chief Development Officer.
Overview of progress
In a letter to shareholders, Dhillon said: “It is rare in biotechnology for a molecule to accelerate from nonclinical work to a Phase 2 study in a year or less. That is precisely where Skye is now.
“We could not be more enthusiastic as a company and a team to be at this transition point with the opportunity unfolding in real-time to potentially validate important new pharmaceutical applications involving the endocannabinoid system.
He said over the past two years, the company has worked towards making Skye stronger as it transitions its lead product, SBI-100, from molecule to medicine.
SBI-100 will be the first drug to move into the clinic that targets the CB1R receptor in the eye, while Skye also expands a pipeline of novel drugs that target the broader ocular endocannabinoid system.
Its drug candidate, SBI-100, is ready to be shipped and received at the clinical trial site in Australia, with recruitment of subjects for this Phase I study to begin before the end of 2022.
By year-end, the goal is to file an Investigational New Drug (IND) application with the US FDA to start Phase II study in the first half of 2023.
These two milestones will mark the culmination of a significant amount of work carried out by the team.
Goals for remainder of 2022 and 2023
Currently, it is focused on the following key milestones:
SBI-100 OE - Phase I safety study in healthy volunteers
- Enroll first arm of trial: single ascending dose (SAD)
- Enroll second arm of trial: multiple ascending dose (MAD)
- Analyze and report data
SBI-100 OE - Phase II safety and efficacy study in primary open-angle glaucoma and ocular hypertension
- Submit IND
- Complete scale-up and on-going process development of SBI-100 manufacturing with Purisys
- Complete production of drug product for Phase II clinical trial with NextPharma
- Engage CRO to manage Phase II clinical trial
- Begin enrollment in H1 2023
R&D
- Achieve clear outcomes of CPIP screening program with further optimization of molecule candidates, supported by relevant data, to expand clinical pipeline
- Present research from CPIP at relevant industry conference(s)
- File patents related to CPIP discovery activities
- Finalize a plan to leverage the Avalite Sciences facility in Canada, which is equipped and licensed to conduct research on controlled substances. This facility may add flexibility and cost savings for its research of molecules classified as Schedule 1 under the US Controlled Substances Act (CSA).
Contact the author at jon.hopkins@proactiveinvestors.com