Skye Bioscience Inc.

Skye concentrates strategy and clinical development on Nimacimab metabolic program and discontinues SBI-100 Ophthalmic Emulsion program. Phase 2 study of Nimacimab in obesity expected to start in Q3 2024.

On Wednesday June 5th, Skye Bioscience's CSO Chris Twitty will present an overview of the company and its programs in obesity and glaucoma at the Jefferies Global Healthcare Conference 2024. You can listen to the webcast here:

wsw.com

On Monday May 13th, Skye Bioscience's CEO and Chair Punit Dhillon will present an overview of the company at the Citizens JMP
Securities Life Sciences
Conference 2024. Listen live at 11:30 am ET or to the recording afterwards by registering here:

wsw.com

After uplisting to the Nasdaq Global Market last week, Skye Bioscience, Inc. will be ringing the Nasdaq bell this Thursday, April 18 at 6:30am PST/9:30am EST! Join us as we mark this exciting milestone in our journey. Stay tuned for the broadcasting link to watch live, coming tomorrow morning! Nasdaq

Skye Bioscience has uplisted to the Nasdaq Global Market, a significant step mirroring its fundamental accomplishments, fundamental life science investors, and capital raised in in the last quarters. We now look forward to reporting Phase 2 glaucoma data in Q2 and starting the Phase 2 obesity study for our CB1 inhibitor in Q3.

Skye has announced that it's entered into a securities purchase agreement for the sale of 4,000,000 shares of its common stock at $10.00 per share to certain investors in a private placement (the "PIPE") to certain qualified institutional buyers. Gross proceeds from the PIPE are expected to be $40 million before deducting any placement agent fees and offering-related expenses. The PIPE financing is expected to close on March 13, 2024, subject to the satisfaction of customary closing conditions.

Read the full story here: https://bit.ly/4c4SFsl

We welcome industry leader, Dr. Annalisa Jenkins, MBBS, FRCP, to our Board of Directors. For additional detail, read the full press release here: https://bit.ly/3Pb7YWr

Today we reported the completed enrollment of our Phase 2a clinical trial of SBI-100 ophthalmic emulsion in glaucoma and ocular hypertension.

For additional details, read the full press release here: https://bit.ly/3SRzOYL

This week, we look forward to joining partners and colleagues at the Glaucoma 360 New Horizons Forum, taking place in San Francisco, California. Company’s management will present during the Innovations in Glaucoma Drugs and Drug Delivery session on Friday, February 9, 2024. See you there!

$SKYE will present at Oppenheimer's Investor Conference Tuesday, February 13, 2024 at 9:40am ET and will also be available for 1x1 meetings. Read the full PR for more details: https://bit.ly/3SRg499

Our CEO Dhillon participated in an interview with to discuss the therapeutic potential of the system, as well as Skye Bioscience’s mission, recent updates and next steps for our Phase 2 clinical development programs. Tune in here!

Exploring the Endocannabinoid System for Drug Development, Featuring Punit Dhillon, Chairman & CEO of Skye Bioscience – Xtalks Life Science Podcast Ep. 144 Hear from Punit Dhillon, Chairman & CEO of Skye Bioscience, a pharma company at the forefront of exploring the endocannabinoid system.

Today, we announced a $50.25 million private placement financing, co-led by leading life science investors, which is expected to fund operations into early 2026, including our planned Phase 2 trial assessing nimacimab in combination with a -1R agonist for patients with . Nimacimab is Skye’s differentiated peripheral CB1 inhibitor.

For additional details on the financing and upcoming milestones read the full press release: https://bit.ly/3S9NWfy

Skye Bioscience stands in recognition of Glaucoma Awareness Month. Join us in spreading awareness about this sight-threatening condition that affects tens of millions of people worldwide. We encourage adults to get eye examinations for early detection and timely treatment.

Join us in recognizing ! Find resources you can share to help raise awareness about : https://nei.nih.gov/learn-about-eye-health/resources-for-health-educators/glaucoma-resources/glaucoma-awareness-month

Skye Bioscience has received IND clearance for its Phase 2 clinical trial of nimacimab in obesity and chronic kidney disease. This trial will assess the impact of our peripherally-acting CB1 inhibitor on weight loss and metabolic biomarkers related to co-morbid obesity and chronic kidney disease. This Phase 2 study is planned to start mid-2024.

For additional details read the full press release: https://bit.ly/3vwIw6T

After Skye’s acquisition of a Phase 2-ready peripheral CB1 inhibitor, nimacimab, in August and advancing our assessment of the clinical and commercial landscape, we are announcing our plan to conduct a Phase 2 study in patients with obesity and chronic kidney disease starting in the first half of 2024. Stay tuned for our developments in the world of weight loss, obesity and CKD treatment!

https://bit.ly/3GFMBb2

Skye has started a new initiative to potentially realize value from one of its existing therapeutic drugs. We’ve entered into an exclusive license agreement with Tautomer Bioscience, enabling them to develop and commercialize our proprietary THC prodrug, SBI-100, as a novel suppository application for chronic intractable pain and other indications in South Africa and the rest of Africa. The CB1 receptor is highly expressed in critical pain-processing regions of the body, and it has long been postulated that cannabinoids such as THC that bind to CB1 can directly modulate pain. We look forward to seeing Tautomer’s steps to introduce a new pain treatment for patients with unmet needs.

For additional details read the full press release: http://bit.ly/40nVSNO

We are proud to announce that today we treated the first patient in our Phase 2 study evaluating the potential of SBI-100 Ophthalmic Emulsion, Skye’s synthetic THC prodrug eyedrop, which converts into tetrahydrocannabinol ("THC") when delivered into the eye and is intended to lower intraocular pressure in patients suffering from glaucoma and ocular hypertension. This marks a critical milestone and interim Phase 2 results will be assessed in Q1 2024.

For additional details read the full press release: bit.ly/40nVSNO

Skye Bioscience will present an overview of its glaucoma program at two ophthalmology-focused conferences:

BTIG 3rd Annual Ophthalmology Day:
Virtual fireside chat: Monday, November 27, 11:30 AM ET

OIS XIII Ophthalmology Innovation Summit:
Live presentation during Innovation Showcase: Friday, December 1, 12:40 – 1:50 pm PT
Location: Omni Hotel San Diego

Read the full PR for more details: bit.ly/40nVSNO

Skye Bioscience is pleased to report successful results from its Phase 1 clinical trial assessing the safety and pharmacokinetics of SBI-100 Ophthalmic Emulsion, being developed for the treatment of glaucoma.

Read the full press release here: bit.ly/40nVSNO

Data from the Phase 1 clinical trial will be discussed in detail during our virtual Investor Day, at 8:00am ET.

Register here: bit.ly/3rRu0VZ

Join Skye Bioscience on October 25, 2023, 8:00am ET for our virtual investor day called "CB1 Axis: Unlocking the Pharmaceutical Potential of the Endocannabinoid System”, featuring Brian Levy, O.D., Glenwood Gum, Ph.D., Sameh Mosaed, M.D., Ph.D. and Skye’s Leadership team.

In conjunction with this event, Skye will also release its Phase 1 clinical data.

Register here: bit.ly/3rRu0VZ

Discussions, insights and topics to be covered:

• Overview of the current glaucoma commercial landscape

• Historical challenges to achieving CB1-targeting therapeutics for the treatment of glaucoma

• Clinical data from Skye’s recently completed Phase 1 study of SBI-100 Ophthalmic Emulsion

• Phase 2 clinical update

• Glaucoma market opportunity and Skye’s positioning strategy

• Live Q&A

Read the full PR here: bit.ly/40nVSNO

Skye Bioscience's ticker symbol has reverted back to 'SKYE' from 'SKYED' following the reverse split.

Today Skye Bioscience announced that it received authorizations for its three clinical trial sites for its Phase 2a study on SBI-100 Ophthalmic Emulsion targeting glaucoma and ocular hypertension. Patient enrollment begins Q4 2023.

We also announced that safety data for Skye's Phase 1 study of SBI-100 OE in healthy volunteers will be reported in October.

Read the full press release here: http://bit.ly/40nVSNO

Skye Bioscience is set to present a corporate overview at both the 2023 Cantor Global Healthcare Conference on September 27th, 2023 and the 16th Annual LD Micro Main Event on October 3, 2023.

Find full details in the press release here: http://bit.ly/40nVSNO

Skye Bioscience announced today that its previously announced reverse split of 1-for-250 of its issued and outstanding stock will be effective before the market open on September 8th. In this process, every 250 pre-existing shares of SKYE will consolidate into one share. Skye Bioscience will be trading under the symbol SKYED on the OTCQB for 20 trading days as of the effective date.

The primary objective for the reverse stock split is to significantly reduce our issued stock to facilitate a potential uplisting to a national stock exchange and expand our access to a broader range of investors. This move is in line with our strategic growth initiatives.

For further information, please visit our Investor FAQ page: https://bit.ly/3r3Vqra

Full press release here: http://bit.ly/40nVSNO

Skye Bioscience will be presenting a corporate overview at the H.C. Wainwright 25th Annual Global Investment Conference. Register to watch the virtual presentation, which will be available on-demand on September 11th at 7:00 AM EST. Register: https://bit.ly/3Zcuhij

Skye has taken key steps that solidify its path through its imminent and important Phase 2a glaucoma study, introduce specialist healthcare investors to its shareholder base, and strategically expand its technology foundation and product development opportunities. Specifically, we raised $17 million. We acquired Bird Rock Bio and its novel CB1 inhibitor, CB1 inhibition being a burgeoning focus for new mechanisms to address diseases with significant prevalence and unmet needs. We brought in 5AM Ventures, which led the financing, and Versant Ventures, as well as other dedicated life science investors through their shareholdings in Bird Rock. These steps reinforce our pioneering efforts focused on unlocking the pharmaceutical potential of the endocannabinoid system.

Key Highlights of this Milestone:

🔬 Advancing Pharmaceutical Innovation:Our acquisition of Bird Rock Bio and funding with specialist life science investors broadens our portfolio of first- and only-in-class technology and deep expertise in product development and company-building.

🚀 Introducing Nimacimab:We are pleased to acquire nimacimab, a distinct mechanism for CB1 inhibition in the form of a peripherally-restricted negative allosteric modulator antibody. Inhibiting CB1 signaling is becoming a strong focus of biotech development, pharmaceutical acquisition, and specialist healthcare investment. This approach has the potential to redefine the landscape of treatments across an array of inflammatory, fibrotic and metabolic-related conditions.

📈 Portfolio Strengthening: While our existing drug, SBI-100 Ophthalmic Emulsion, is a CB1 agonist, or activator, nimacimab’s mechanism to inhibit CB1 signaling is completely distinct and complementary in its focus. The multiple increase in Skye’s potential addressable market of patients with unmet needs is substantial. The acquisition of Bird Rock Bio expands our opportunities and diversifies our risk. It also enhances Skye's standing as a leader in
endocannabinoid system-focused pharmaceuticals.

📅 Upcoming Milestones: We look forward to reporting Phase 1 results for SBI-100 Ophthalmic Emulsion, Skye's existing clinical candidate, by the end of Q3 2023. Additionally, our Phase 2a study – Skye’ first Phase 2 study! – which aims to reduce intraocular pressure in patients with glaucoma will commence dosing in Q4 2023.

🎙️ Learn More: To gain a comprehensive understanding of this important evolution of Skye, we invite you to access the on-demand call and related presentation slides that complement our news release. These resources will be accessible through the investor News and Events section on Skye's official website.
We extend our heartfelt gratitude to our committed team, visionary partners, esteemed investors, and our community. Your continued support and trust have paved the way for this achievement.

Stay tuned for further updates as we continue our journey to redefine pharmaceutical possibilities based on endocannabinoid science.

Best from the Skye Team.

Read the full press release here: http://bit.ly/40nVSNO

Listen to the conference call and learn more about the transaction here: https://bit.ly/3E6qhpM

Tu Diep, Chief Development Officer of Skye Bioscience, will present a company overview at the H.C. Wainwright 3rd Annual Ophthalmology Virtual Conference being held virtually on Wednesday, August 16th, 2023. An on-demand presentation will be made available on August 16, 2023, at 7:00 AM ET.

Watch the presentation here: https://bit.ly/47tsVn9

The safety review committee for Skye Bioscience's Phase 1 clinical trial of SBI-100 Ophthalmic Emulsion reviewed the study’s final cohort and the data did not exhibit any safety signals of concern. We look forward to reporting preliminary data and starting our Phase 2a study in glaucoma patients in Q3.

PR: http://bit.ly/40nVSNO

Skye Bioscience's contract manufacturer, NextPharma Oy, has completed production of placebo and SBI-100 Ophthalmic Emulsion for its planned Phase 2a study of glaucoma and ocular hypertension. Skye is completing additional steps necessary to start this study.

Read the full press release: http://bit.ly/40nVSNO