Source: Skye Bioscience, Inc. 1/10/2022
Skye Bioscience, Inc. (OTCQB: SKYE) (“Skye”), a pharmaceutical company developing proprietary, synthetic, cannabinoid-derived molecules to treat diseases with significant unmet need, issued today the following letter from Chief Executive Officer and Chair, Punit Dhillon.
Dear Shareholders, Colleagues and Collaborators,
I would like to thank you for your steadfast support and dedication in bringing our novel cannabinoid-based compounds to life as a potential new class of medicines.
Over the last 18 months, our singular mission has been to establish Skye’s novel cannabinoid-based compound for glaucoma as an important medicine for patients, recognizing that we are operating in a global pharmaceutical market that is changing rapidly and challenging us to stay one step ahead of the curve in terms of innovation. This is the urgency that drives us as we focus on consistently executing our goals until meaningful progress is achieved.
2021 represented an important year of fundamental progress for Skye. We further strengthened our team and work towards completing the preclinical development necessary to advance SBI-100 into the clinic. Our preclinical research to date gives us confidence that SBI-100 can be a promising drug candidate to treat glaucoma, the world’s leading cause of irreversible blindness.
The journey to prepare our lead product, SBI-100, for its next stage of development has not come without challenges, especially when set against the backdrop of a global pandemic. However, we are now on the verge of entering the most exciting and rewarding phase – becoming a clinical-stage company with a drug-disease combination that has the ability to produce a possibly significant and meaningful data outcome in a short and resource-efficient manner. The potential impact of our drug on glaucoma inspires us to also target a broader range of ocular diseases, pave the path for the adoption of novel cannabinoid compounds, and expand Skye’s drug pipeline.
Today, I am pleased to
provide you with updates on our progress and insight into 2022 with a
bold commitment to pursue every opportunity within our means to develop
and expand an ophthalmology pipeline. We are preparing to make
significant headway with the clinical development of SBI-100, the
expansion of our R&D program, and the placement of resources and
capabilities to support our escalating contributions toward disruptive
innovation in the development of pharmaceutical cannabinoids.
SBI-100: Opportunity to Transform the Treatment of Glaucoma
At
Skye, innovation lies at the center of our research and development
process, and it drives our belief that targeting cannabinoid receptors
has broad applicability to modify diseases in the eye. The basis of drug
development at Skye rests on evidence that modulation of the
endocannabinoid system (ECS) can provide therapeutic benefit for
multiple diseases. By targeting ECS receptors such as CB1, CB2, PPAR-y,
and GPR55, we can develop drugs to address an extensive set of
pathologies in ophthalmology. For the ocular setting, this means showing
improvement or modification of intraocular pressure, pain,
inflammation, neovascularization, wound healing, neuroprotection, and
fibrosis.
In 2021, we completed several important preclinical studies to demonstrate the safety and efficacy of SBI-100. In vitro safety studies included an epi-ocular irritation study that demonstrated little to no irritation induced by its eye drop formulation, plus genotoxicity studies that demonstrated SBI-100 caused no chromosomal damage or genetic mutations.
In vivo efficacy studies included a combination study that again demonstrated SBI-100’s ability to decrease intraocular pressure (IOP) to a greater degree and over a longer duration than the standard of care for the treatment of glaucoma as a standalone agent. The studies also demonstrated SBI-100's ability to further enhance the IOP-lowering benefit when co-administered with other classes of commercially available therapies, such as rho-kinase inhibitors. This data was presented at the American Association of Pharmaceutical Scientists (AAPS) and has been submitted to a peer-reviewed journal for publication consideration.
Additionally, I am pleased to share that we recently completed our good laboratory practice (GLP) toxicology study, which provides the final non-clinical dataset required for submission to the Australian Therapeutic Goods Administration to receive ethics approval, a necessary step before initiating our first-in-human trials with SBI-100. Before the end of 2021, we also completed a neuroprotection study to assess the potential of SBI-100 to protect retinal ganglion cells in an optic nerve crush model. We plan to share additional details from both studies upon a thorough review of the findings in the near term.
SBI-100 Entering the Clinic in 2022
We
are fast approaching the initiation of our first-in-human Phase I study
in the first half of 2022, with topline data expected in the third
quarter of 2022 and the full data readout in the fourth quarter. Our
Phase I study will evaluate the safety and tolerability of SBI-100 in
healthy volunteers. The objective is to check an important box for
regulatory authorities by demonstrating that our drug has minimal to no
side effects in the eye and no unwanted systemic side effects from THC.
What is more significant, of course, is potentially demonstrating the IOP-reducing effects of SBI-100 in patients with glaucoma. We have therefore laid out a plan to initiate a Phase II study before the end of 2022. This study will be designed to evaluate the IOP-reducing effects of SBI-100 compared to both placebo control and an active control. It will be conducted in the US through an Investigational New Drug (IND) application, and I am pleased to share that in December 2021 we completed our pre-IND meeting with the U.S. Food and Drug Administration (FDA). We received valuable guidance from the FDA regarding the clinical development of SBI-100 in the U.S. and they agreed with the overall design of the proposed Phase II efficacy trial. This provides Skye with a clear path to move forward with an IND submission and, subject to approval, the initiation of its Phase II study, which we expect to begin in Q4 2022.
Cannabinoid Pharmaceutical Innovation Program
In
the fourth quarter, we announced the launch of a new initiative to
establish a proprietary screening platform to identify novel compounds
with potential therapeutic benefit in ophthalmology and other diseases.
This research with leading experts and academic collaborators around the
world offers the prospect of increasing Skye’s development pipeline. It
also raises the bar for the entire ophthalmology and cannabinoid
research field, bringing a science-based proprietary approach to these
potential medicines to benefit patients.
Expansion of Leadership Team
In
the second half of 2021, we added substantial depth to our leadership
team, adding vital roles and pertinent pharmaceuticals development
experience, notably in the area of ophthalmology during a time of
exponential growth.
Kaitlyn Arsenault, CPA - Chief Financial Officer
Ms.
Arsenault brings over 14 years of experience in accounting, auditing,
financial reporting, mergers, acquisitions, and business operations in
the life science and technology sectors. Prior to her appointment as CFO
of Skye, she served as an independent consultant for emerging public
and private companies, including Skye, for the past six years, providing
expertise and addressing complex issues related to SEC reporting,
technical accounting, stock-based compensation, and revenue recognition,
among other subjects.
Tu Diep, MSc. - Chief Development Officer
Mr.
Diep, a proven leader in drug development, brings more than 15 years of
experience in research, clinical and strategic operations, business
process, CMC, regulatory affairs, and business development.
Rhea Williams, MPH - Head of Regulatory Affairs and Quality Assurance
Ms.
Williams brings over 25 years of experience in drug development,
regulatory affairs, and quality assurance. She’s supported the
development of small and large molecules in the areas of neurology,
hematology, oncology, women’s health, cardiology, and ophthalmology.
Previously she held management positions at Johnson & Johnson,
Schering-Plough, and Eisai.
Varun Khurana, PhD - Senior Director of Research and Development
Dr.
Khurana brings over 7 years of comprehensive experience in
pre-formulation and formulation development, technical transfer, CMC,
CMO/CRO management, and regulatory submissions for innovative and
complex drug development programs. His expertise encompasses product
ideation, portfolio strategy, due diligence, lifecycle management, and
intellectual property strategy. Dr. Khurana has worked on several dosage
forms, including ophthalmic, injectable, oral, and sublingual.
We also announced the appointment of two new independent directors to the board, who bring extensive experience in ophthalmic drug clinical development.
Praveen Tyle, PhD – Director
Dr.
Tyle is a biotech executive with over 37 years of broad pharmaceutical
executive leadership, extensive experience working with ocular
disorders, and a wealth of academic insight. He serves as President,
CEO, and Director of Invectys, Inc. and previously held senior
leadership positions at Novartis and Bausch & Lomb.
Keith W. Ward, PhD – Director
Dr.
Ward is a life sciences executive with over 25 years of experience in
the biotech and pharmaceutical industry. He is President and CEO of
InterveXion Therapeutics and was previously Global Vice President of
Pharmaceutical R&D at Bausch & Lomb.
Financial Update
In
2021, we completed a financing of $7.0 million via a registered direct
offering. These proceeds are being used primarily for preclinical and
clinical development of SBI-100, R&D activities, and general
corporate purposes.
As of September 30, 2021, our cash position was $11.1M, an increase of $6.9M from $4.2M on September 30, 2020. Our working capital was $9.9M and stockholders’ equity was $8.3M, positioning us with the strongest balance sheet in the Company’s history and enabling us to advance our development initiatives.
Looking Forward in 2022
As
with all diseases, the main driver for innovation in ophthalmology is
unmet patient need. This is where Skye has an exceptional opportunity to
be disruptive. At Skye, our innovation and development strategy and
value creation plan are linked to the following milestones for 2022:
1. Completion of a Phase I study to establish safety and tolerability of SBI-100 in humans
2. Initiation of a robust placebo and active-controlled Phase II study for SBI-100 in glaucoma
3. Development
of a drug development platform to uncover novel molecules and
mechanisms of action capable of modulating the endocannabinoid system to
improve outcomes for a broad set of ophthalmic disease
2022 will
undoubtedly be a transformative year for Skye. We have positioned the
Company to execute on its ambitious agenda, transitioning from a
preclinical to clinical-stage company and pursuing the compelling
opportunities ahead of us.
As always, we thank you for your continued support and on behalf of the entire Skye team, we wish you a safe, healthy, and prosperous 2022.
Sincerely,
Punit Dhillon
CEO & CHAIR
About Skye Bioscience
Skye
Bioscience Inc. is a biopharmaceutical company unlocking the
pharmaceutical 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.
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