San Diego, California, July 20, 2022 (GLOBE NEWSWIRE) — Skye Bioscience, Inc. (OTCQB: SKYE) (“Skye” or the “Company”), a pharmaceutical company developing a proprietary, synthetic cannabinoid derivative to treat glaucoma, has been advised by its contract manufacturer (“CMO”) of its Phase 1 clinical trial material that a now-resolved cyber-attack on the CMO’s computer systems as well as a planned annual maintenance shutdown will result in a delay in completing production of Skye’s Phase 1 drug to the beginning of September. Skye now expects to initiate enrollment of its Phase 1 clinical study in Q4 2022, report preliminary topline data in early Q1 2023, and report final data in Q2 2023.

Skye’s SBI-100 Ophthalmic Emulsion (“SBI-100 OE”) had most recently been scheduled for production and fill in the first week of July. While the CMO has sufficiently recovered from the recent cyber-attack, planned annual facility maintenance could not be rescheduled. The maintenance schedule has been accelerated and will be conducted through August 30.  Skye’s SBI-100 product is now planned to be produced and filled in the first week of September, with required drug quality testing completed by the first half of October.

“The unpredictable events that have detrimentally affected our production schedule have been frustrating, but we are confident in the renewed commitment of our contract manufacturer to produce our clinical trial material and the schedule to start our planned study,” said Punit Dhillon, CEO and Chair of Skye. “Securing approval for the Australian Human Research Ethics Committee at the end of June was a vital factor to move our Phase 1 forward. While the delay in the Phase 1 is not a welcomed outcome, we are pleased that we continue to progress on the logistics that move us toward enrollment and dosing of the first cohort of patients.

“As we previously noted, we are in parallel progressing our Phase 2 clinical development plan. In our preliminary meeting last winter with the FDA to discuss our planned Investigational New Drug (“IND”) application, the FDA confirmed that, as is standard practice with all ophthalmology clinical studies, it would accept from Skye nonclinical toxicology data for review and approval of its IND and Phase 2 protocol rather than requiring Phase 1 safety data. The Phase 1 study outcome will provide us the benefit of safety and tolerability data of SBI-100 OE but is not a gating factor to initiate Phase 2. We continue to look forward to obtaining Phase 1 data but concurrently developing our clinical plans with the expectation that we can report Phase 2 by year-end 2023.”

About SBI-100 Ophthalmic Emulsion
Increased intraocular pressure (IOP) is a key risk factor in the progression of glaucoma. The first observations that consuming cannabis lowered IOP in humans took place in the early 1970s, which led to a significant amount of research on the effects of cannabinoids in the eye. Independent studies demonstrated that activation of the cannabinoid receptor-type 1 (CB1R) in ocular tissue mediates IOP-lowering. However, no cannabinoid-related drug has been approved for clinical use in the eye due primarily to the shortcomings of current delivery methods of CB1R agonists to the eye in a therapeutically beneficial dose. When cannabinoids are administered systemically, they can lower IOP but also result in undesirable psychotropic effects. Alternatively, extracted natural cannabinoids delivered topically as an eye drop do not penetrate ocular tissue well enough to effectively lower IOP due to the lipophilic, or oily, properties of natural cannabinoids and the aqueous, or watery, surface of the eye.

To address these challenges, Skye developed SBI-100 OE, a proprietary, synthetic cannabinoid derivative possessing a novel molecular structure and formulation that was rationally designed to enable better penetration of ocular tissue and effective topical delivery of a CB1R agonist. In preclinical studies involving three different species, a nanoemulsion formulation of the drug applied topically to the eye resulted in enhanced therapeutic efficacy and duration of response in lowering IOP. Importantly, these studies also demonstrated advantages compared to today’s standard of care and, if clinically validated in subsequent efficacy studies, may provide a suitable therapeutic window to be a new class of medicine for glaucoma.

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: [email protected]
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.

This article was published by CFN Enterprises Inc. (OTCQB: CNFN), owner and operator of CFN Media, the industry’s leading agency and digital financial media network dedicated to the burgeoning CBD and legal cannabis industries. Call +1 (833) 420-CNFN for more information.

About Ryan Allway

Mr. Allway has over a decade of experience in the financial markets as both a private investor and financial journalist. He has been actively involved in the cannabis industry since its inception, covering public and private companies.

SAN DIEGO, CA, Feb. 01, 2022 (GLOBE NEWSWIRE) — Skye Bioscience, Inc. (OTCQB: SKYE) (“Skye” or the “Company”), a pharmaceutical company developing proprietary, synthetic cannabinoid-derived molecules to treat glaucoma and other diseases with significant unmet need, announced that in a preclinical study assessing the neuroprotective properties of its SBI-100 ophthalmic nanoemulsion, the treated group demonstrated a trend of retaining greater function of the eye’s retinal ganglion cells (RGCs) versus vehicle control. RGCs are cells which process and transmit visual information to the brain.

“There is broad scientific evidence demonstrating the neuroprotective properties of cannabinoids, notably THC, and these results from our proprietary THC-based drug candidate are encouraging,” said Punit Dhillon, Chief Executive Officer. “As a leader in pharmaceutical cannabinoid development, it is imperative that Skye explore the broad mechanisms and potential benefits of cannabinoid drug candidates and we will continue our efforts on this path as we maintain our current focus on initiating our first-in-human study of SBI-100 in the second quarter.”

Glaucoma is a neurodegenerative disease of RGCs associated with degeneration of the optic nerve that leads to vision loss. Today the only addressable risk factor in glaucoma is elevated intraocular pressure (IOP). While pharmacological and surgical interventions can lower IOP and slow disease progression, they do not address underlying RGC degeneration. Furthermore, a considerable proportion of glaucoma patients experience disease progression and gradual vision loss without elevated IOP, which available therapies are unable to treat. These scenarios point to the need for a new class of glaucoma medicine with further-reaching capabilities.

This study was conducted using an aggressive optic nerve crush (ONC) model in rats to evaluate the neuroprotective potential of SBI-100. The ONC model aims to accelerate and stimulate the pathology seen in glaucoma using an acute mechanical crush injury to the optic nerve through a minimally invasive procedure. This crush injury triggers the death of RGCs and consequently the loss of their function.

A baseline assessment of the function and structure of RGCs was measured seven days before the crush injury was applied to one eye (leaving the uninjured contralateral eye to serve as a control). The treatment groups received either SBI-100 or control beginning three days prior to injury and until seven days post-injury.

Measurements of retinal function were evaluated using pattern electroretinography (pERG), an electrophysiologic diagnostic test that measures the electrical responsiveness of RGCs to light stimuli. Results from this quantitative assay demonstrated SBI-100 treated animals showed a mean trend of higher function of RCGs compared to untreated animals.

Structural evaluations used high-resolution imaging to examine differences in the thickness of the retinal nerve layer, which thins as RGCs are lost, as well as immunohistological staining to assess RGC-specific biomarkers and compare the number of RGCs in treated patients vs. vehicle groups. In these evaluations, little to no difference was observed in the structure of the retinal nerve layer nor the number of RGCs between the treated and untreated groups.

“The apparent difference in function as measured by pERG at day 7 between SBI-100 ophthalmic emulsion and vehicle control is very interesting and deserves further investigation. Although other measures do not appear to demonstrate differences in this particular model, we remain encouraged by the results of this preliminary study,” said Tu Diep, Chief Development Officer. “Our research and development team, in collaboration with our advisors, intend to undertake further steps to interrogate the neuroprotective benefits of SBI-100 through other models of glaucoma and neurodegeneration. We are excited to be on the cutting edge of this important scientific work.”

About SBI-100
SBI-100, a proprietary prodrug of tetrahydrocannabinol (THC), is a topical ocular formulation under development for the treatment of glaucoma. Developed with rational drug design and biochemical engineering, SBI-100 is a proprietary synthetic molecule that enables local delivery of the drug into the eye and reduces the potential for systemic side effects. In nonclinical studies, SBI-100 demonstrated superior lowering of intraocular pressure, a major risk factor related to irreversible vision loss, compared to the standard-of-care glaucoma treatment.

About Skye Bioscience
Skye Bioscience Inc. is a pharmaceutical company unlocking the potential of cannabinoids through the development of its proprietary, cannabinoid-derived molecules to treat diseases with significant unmet needs. The company’s lead program, SBI-100, is focused on treating glaucoma, a disease with no cure and the world’s leading cause of irreversible blindness. For more information, please visit: www.skyebioscience.com.

CONTACT
Angelita Garcia
Director, Corporate Communications
Email: [email protected]
Phone: (858) 410-0266

FORWARD LOOKING STATEMENTS
This letter contains forward-looking statements, including statements regarding our product development, business strategy, 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.

This article was published by CFN Enterprises Inc. (OTCQB: CNFN), owner and operator of CFN Media, the industry’s leading agency and digital financial media network dedicated to the burgeoning CBD and legal cannabis industries. Call +1 (833) 420-CNFN for more information.

About Ryan Allway

Mr. Allway has over a decade of experience in the financial markets as both a private investor and financial journalist. He has been actively involved in the cannabis industry since its inception, covering public and private companies.