Skye Bioscience Reports that Emerald Health Therapeutics Shareholders Voted in Favor of Plan of Arrangement with Skye

Rhea-AI Summary

Skye Bioscience (OTCQB: SKYE) announces that 87.07% of Emerald Health Therapeutics shareholders approved the proposed merger plan. The next step involves Skye seeking shareholder approval in an upcoming meeting. Regulatory approval for Skye's Phase 1 clinical study has been granted, with enrollment expected to complete by early 2023. The company plans to submit its Investigational New Drug application to the FDA by year-end 2022 for a Phase II study on SBI-100 targeting glaucoma, a condition affecting over 70 million people worldwide.

Positive

• 87.07% shareholder approval for merger with Emerald Health Therapeutics.
• Regulatory approval for Phase 1 clinical study confirmed.
• Expected completion of Phase 1 study enrollment by early 2023.
• Plan to file Investigational New Drug application with FDA by end of 2022.

Negative

• Emerald is winding down its cannabis operations, which may impact Skye if the merger succeeds.

San Diego, California, Aug. 19, 2022 (GLOBE NEWSWIRE) -- Skye Bioscience, Inc. (OTCQB: SKYE) (“Skye” or the “Company”), a pharmaceutical company developing a proprietary, synthetic cannabinoid derivative to treat glaucoma, reports that the shareholders of Emerald Health Therapeutics, Inc. ("Emerald" or the "Company") (CSE: EMH; OTCQB: EMHTF) today approved the proposed plan of arrangement (the "Arrangement") with Skye, with approval by 87.07% of votes cast by shareholders for that resolution. The Arrangement resolution also received majority of the minority approval, excluding interested parties, pursuant to applicable law.

Emerald will now seek a final order from the Supreme Court of British Columbia to approve the Arrangement.

Completion of the Arrangement remains subject to approval by the shareholders of Skye, which is expected to be obtained at Skye’s shareholder meeting to be held in October or November, subject to SEC review of the proxy, if applicable. The transaction is expected to close shortly thereafter, subject to Skye obtaining listing approval from the CSE and satisfaction of other customary conditions.

“We are very pleased to see strong voting participation by Emerald Health Therapeutics shareholders at this meeting and their clear support of the proposal to merge with Skye Bioscience,” said Punit Dhillon, CEO and Chair of Skye. “We are preparing for Skye’s shareholder meeting to vote on the plan of arrangement, and we continue to take the required steps to start our planned Phase 1 study in the fourth quarter.”

Updates

Emerald has substantially completed the wind-down of its cannabis operations and is working to exit remaining leases and to find a purchaser for its Quebec production facility.

Skye has regulatory approval to start its Phase 1 clinical study. It has also announced that it expects its contract manufacturer to start manufacturing Skye’s placebo and SBI-100 drug products for the Phase I clinical study to establish the safety and tolerability of SBI-100 in early September. 

Skye has also announced that it expects to complete its Phase I clinical study enrollment in early 2023 and to release interim data from that study in Q2 2023.

Skye expects to file its Investigational New Drug application with the US FDA before the end of 2022 to obtain clearance to initiate a United States Phase II study in the first half of 2023. This study will assess the efficacy of SBI-100 in treating patients with primary open angle glaucoma and ocular hypertension. Skye expects to report data from this study by year-end 2023.

Glaucoma affects over 70 million people in the world and its prevalence is increasing. This disease has needs that are not fulfilled by current drugs and there is a significant opportunity to beneficially affect patients with a novel class of drug such as SBI-100.

About Skye Bioscience
Skye Bioscience is a pharmaceutical company unlocking the potential of cannabinoids through the development of its proprietary cannabinoid derivatives to treat diseases with significant unmet needs. The company’s lead program, SBI-100 OE, is focused on developing a treatment for glaucoma, the world’s leading cause of irreversible blindness. For more information, please visit: www.skyebioscience.com.

CONTACT
Investor Relations
Email: ir@skyebioscience.com  
Phone: (858) 410-0266

FORWARD LOOKING STATEMENTS
This letter contains forward-looking statements, including statements regarding our product development, business strategy, the timing of clinical trials, and commercialization of cannabinoid-derived therapeutics. Such statements and other statements in this press release that are not descriptions of historical facts are forward-looking statements that are based on management’s current expectations and assumptions and are subject to risks and uncertainties. If such risks or uncertainties materialize or such assumptions prove incorrect, our business, operating results, financial condition, and stock price could be materially negatively affected. In some cases, forward-looking statements can be identified by terminology including “anticipated,” “plans,” “goal,” “focus,” “aims,” “intends,” “believes,” “can,” “could,” “challenge,” “predictable,” “will,” “would,” “may” or the negative of these terms or other comparable terminology. We operate in a rapidly changing environment, and new risks emerge from time to time. As a result, it is not possible for our management to predict all risks, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements the Company may make. Risks and uncertainties that may cause actual results to differ materially include, among others, our capital resources, uncertainty regarding the results of future testing and development efforts and other risks that are described in the Risk Factors section of Skye’s most recent annual or quarterly report filed with the Securities and Exchange Commission. Except as expressly required by law, Skye disclaims any intent or obligation to update these forward-looking statements.

FAQ

What is the significance of the 87.07% vote by Emerald Health Therapeutics shareholders for SKYE?

The 87.07% vote indicates strong support for the merger, allowing Skye to progress with the proposed plan.

When is Skye's shareholder meeting to vote on the merger plan expected to take place?

Skye's shareholder meeting is expected to occur in October or November 2022.

What is the timeline for Skye's Phase 1 clinical study?

Skye anticipates completing Phase 1 clinical study enrollment by early 2023.

What are the future plans for SKYE in relation to FDA filings?

Skye aims to file its Investigational New Drug application with the FDA by the end of 2022.

How many people globally are affected by glaucoma, according to SKYE?

Over 70 million people worldwide are affected by glaucoma.