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.

– Last subject completed study in late 2021 with topline results expected in early 2022 –

– Results to inform design of Phase 2a study in individuals undergoing supervised opioid withdrawal –

NEW YORK, Jan. 4, 2022 /CNW/ — Mind Medicine (MindMed) Inc. (NASDAQ: MNMD), (NEO: MMED), (DE: MMQ) (the “Company”), a leading biotech company developing psychedelic-derived therapies, today announced the completion of its Phase 1 clinical trial of 18-MC, the Company’s non-hallucinogenic proprietary derivative of ibogaine, being developed for the treatment of indications linked to opioid use disorder. The trial was completed in December 2021 with topline results expected in early 2022.

“This is an exciting milestone, and we look forward to announcing the results of our Phase 1 study in the coming months,” said Robert Barrow, Chief Executive Officer and Director of MindMed. “The growing opioid crisis claims over 75,000 lives each year and impacts more than we’ll ever know. While ibogaine has been used and studied as a treatment for opioid addiction, its efficacy, while promising, has been overshadowed by significant safety concerns. Our proprietary molecule, 18-MC, has indicated an encouraging safety profile and preclinical efficacy data setting the stage for our Phase 2a proof-of-concept study in individuals undergoing opioid withdrawal. We expect to initiate this study in early 2022, which will evaluate the safety, tolerability and efficacy of 18-MC in mitigating the symptoms of opioid withdrawal.”

Phase 1 Trial Design

This Phase 1 single and multiple ascending dose trial conducted at a single clinical research site in Perth, Australia, evaluated the safety, tolerability, pharmacokinetics, and effects on cognitive activity of 18-MC in healthy volunteers. Subjects either received doses between 4 and 325 milligrams twice per day (for one day; n=5 per arm) or doses between 2 and 90 milligrams twice per day (for up to 7 days, n=5 per arm).

About 18-MC

18-MC is an alpha-3-beta-4 nicotinic receptor antagonist with a differentiated mechanism of action that modulates excessive dopamine fluctuations in the mesolimbic system of the brain. 18-MC is a synthetic organic molecule designed around a coronaridine chemical backbone common to a number of plant-based medicinal compounds, including ibogaine. In preclinical efficacy models, 18-MC has demonstrated strong activity in reducing both withdrawal symptoms and self-administration of opioids, stimulants and other substances of abuse. Extensive preclinical characterization has shown 18-MC to have a strong safety and tolerability profile. Importantly, 18-MC has the potential to overcome safety limitations of ibogaine and has not demonstrated proarrhythmic or neurotoxic activity.

About MindMed

MindMed is a clinical-stage biotech company that seeks to discover, develop and deploy psychedelic-inspired medicines and therapies to address mental health and addiction. The Company is assembling a compelling drug development pipeline of innovative treatments based on psychedelic substances including psilocybin, LSD, MDMA, DMT and an ibogaine derivative, 18-MC. The MindMed executive team brings extensive biopharmaceutical experience to MindMed’s approach to developing the next generation of psychedelic-inspired medicines and therapies.

MindMed trades on the NASDAQ under the symbol MNMD and on the Canadian NEO Exchange under the symbol MMED. MindMed is also traded in Germany under the symbol MMQ.

Forward-Looking Statements

Certain statements in this news release related to the Company constitute “forward-looking information” within the meaning of applicable securities laws and are prospective in nature. Forward-looking information is not based on historical facts, but rather on current expectations and projections about future events and are therefore subject to risks and uncertainties which could cause actual results to differ materially from the future results expressed or implied by the forward-looking statements. These statements generally can be identified by the use of forward-looking words such as “will”, “may”, “should”, “could”, “intend”, “estimate”, “plan”, “anticipate”, “expect”, “believe”, “potential” or “continue”, or the negative thereof or similar variations. Although the Company believes that the expectations reflected in our forward-looking information are reasonable, such information involves risks and uncertainties, and undue reliance should not be placed on such information, as unknown or unpredictable factors could have material adverse effects on future results, performance or achievements of the Company. There are numerous risks and uncertainties that could cause actual results and the Company’s plans and objectives to differ materially from those expressed in the forward-looking information, including the risks described under the headings “Risk Factors” in the Company’s filings with the securities regulatory authorities in all provinces and territories of Canada which are available under the Company’s profile on SEDAR at www.sedar.com and with the U.S. Securities and Exchange Commission on EDGAR at www.sec.gov. Should one or more of these risks or uncertainties materialize, or should assumptions underlying the forward-looking information prove incorrect, actual results and future events could differ materially from those anticipated in such information. Although the Company has attempted to identify important risks, uncertainties and factors that could cause actual results to differ materially, there may be others that cause results not to be as anticipated, estimated or intended. These and all subsequent written and oral forward-looking information are based on estimates and opinions of management on the dates they are made and are expressly qualified in their entirety by this notice. Except as required by law, the Company does not intend and does not assume any obligation to update this forward-looking information.

For Media: [email protected]

For Investors: [email protected]

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.