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SAN DIEGO, CA, Aug. 10, 2021 (GLOBE NEWSWIRE) -- Skye Bioscience, Inc. (OTCQB: SKYE) (“Skye”), a biopharmaceutical company developing proprietary, synthetic cannabinoid-derived molecules to treat diseases with significant unmet need, has successfully completed genotoxicity studies of THCVHS required prior to beginning its planned Phase 1 clinical study in Australia. Skye is initially developing THCVHS as a treatment of glaucoma.
Genotoxicity safety studies are required by both the Australian Therapeutic Goods Administration and the U.S. Food & Drug Administration prior to initiating human trials and were completed at BioReliance Corporation under Good Laboratory Practices regulations, which meet the standards for both agencies. BioReliance is the world’s leading provider of safety testing services and includes among its customers many of the largest pharmaceutical, biopharmaceutical, and chemical companies around the globe.
“Genotoxicity data are a prerequisite to enter into human trials in all major markets. Although the safety profile for the active pharmaceutical ingredient, THC, is well-recognized, this was the first time these studies were performed with our proprietary molecule THCVHS, a prodrug of THC,” said Punit Dhillon, CEO of Skye Bioscience. “We are pleased to have successfully completed these studies and continue to advance our nonclinical requirements prior to initiating our first-in-human trial, as well as future clinical trials in the US.”
Two studies were carried out to assess the genotoxicity potential of THCVHS. The first was a mammalian cell micronucleus assay, which is designed to determine a compound’s ability to generate chromosomal aberrations and considered to be one of the most reliable assays in determining genotoxicity. The second study was a reverse bacterial mutagenesis assay, also referred to as the Ames test, which assesses the ability of a compound to generate gene mutations. Both assays produced negative results indicating that THCVHS is not a genotoxic compound, clearing a key step to allow for human trials.
About THCVHS
THCVHS, a proprietary prodrug of tetrahydrocannabinol (THC), is a topical formulation under development to treat glaucoma. Through the application of rational drug design, Skye has chemically modified THC to create a unique synthetic molecule with the intent to safely realize the known positive effects of THC. THCVHS enables enhanced local delivery of the drug into the eye, provides significant lowering of intraocular pressure, minimal systemic exposure, and potential for neuroprotection.
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, THCVHS, 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.
why the volume surge? And the bump up?
Skye Bioscience Appoints Biotech Executive Praveen Tyle, Ph.D. to Board of Directors
Download as PDF July 26, 2021 8:30am EDT
SAN DIEGO, CA, July 26, 2021 (GLOBE NEWSWIRE) -- Skye Bioscience, Inc. (OTCQB: SKYE) (“SKYE” or the “Company”), a biopharmaceutical company developing proprietary, synthetic cannabinoid-derived molecules to treat glaucoma and other diseases with significant unmet need, has appointed Praveen Tyle, Ph.D., as an independent director to the Company’s board. Dr. Tyle brings over 35 years of experience in the pharmaceutical industry, with over 37 years in senior executive leadership positions encompassing research and development, clinical development, manufacturing, regulatory, business development and operations as well as roles as a board director and scientific advisory board member.
"We are delighted to have Dr. Tyle join Skye’s board of directors. We believe his broad leadership experience will prove invaluable as we advance our lead clinical program and execute strategies to expand our development portfolio,” said Punit Dhillon, Chief Executive Officer and Chair of Skye Bioscience. “With expertise originating from a deep scientific foundation, Praveen has extensive cross-functional experience working with companies at various stages spanning big pharma through start-up biotech. He has experience in multiple disease areas including ocular disorders and brings a wealth of industry and academic insight. We look forward to his contribution and guidance.”
"Skye's unique and innovative approach has the potential to treat a range of diseases with significant unmet needs," said Dr. Tyle. "I am honored to join Skye’s Board of Directors and look forward to contributing to the Company's advancement of its promising product candidates through clinical development."
Dr. Tyle is currently President & Chief Executive Officer and a director of Invectys, Inc, an immuno-oncology company spun out of the world-renowned Pasteur Institute. He was previously President & Chief Executive Officer and a director of Osmotica Pharmaceutical Corp, focused on central nervous system drug development. In past roles Dr. Tyle served at Novartis OTC as Senior Vice President and Global Head of Business Development and Licensing as well as Senior Vice President & Global Head of Research and Development. Earlier in his career he was Corporate Senior Vice President and Chief Scientific Officer of Bausch & Lomb.
Dr. Tyle was also an Adjunct Associate Professor of Ophthalmology at the University of Rochester Eye Institute Medical Center, among other current and past academic roles. He has co-authored over 100 peer-reviewed academic papers and presentations and is named on multiple patents, including patents related to ophthalmic innovations, drug delivery and glaucoma.
SKYE PREFORMING BEAUTIFUL LOOKING GREAT HERE. ..
I am hoping for this to go back to 1.00 plus. I am a longtime shareholder avg down to .61. Still in the red for me but I think this is a great company and hopefully gets acquired and/or gets the product out sooner than later!
Skye good informative video
The Holy Grail for the treatment of glaucoma? Tune in. #pharma #biopharmaceutical #cannabis #cannabinoids #thc #thcvhs pic.twitter.com/qGvGyLIblM
— Benzinga (@Benzinga) June 2, 2021
This News was Awesome looking Foward... https://finance.yahoo.com/news/skye-bioscience-thcvhs-demonstrates-superior-124200796.html
Undervalued... In the whole time I have been watching the stock since 2013.. If you got 14 cents you were very lucky.. Anything under 20 cents was a gift. I mean trading at 0.03 and 0.05 cents for months was ridiculously low.... Not to mention positive news from Preclinical trials lately congratulations all.. .. https://finance.yahoo.com/news/skye-bioscience-thcvhs-demonstrates-superior-124200796.html
I got an "alert" two days ago from a service that I subscribe to. It's not the $5000 a year program they have. But they give a few picks to check out. I think I was not supposed to get the "red alert" thingy as I do not subscribe for the full service like the big guys do because I cannot find the notice in the area I am allowed. Said to buy up to 0.15. I do not know if they are long or if it is a flipper. They usually give a notice when they are exiting a position and where. I have not received that notice. SKYE is in an area of bio that is "hot." Who else has the results SKYE has on there preliminary trial? None that I have seen. I hoped to find something on this board but it is not very active. I kind of like that.
why the sudden upswing? are there any news release or catalyst for this stock i don't know about?
I am very happy, i loaded up and averaged down..i was down 70% a few months ago and now i am GREEN
is this being promoted on twitter lol?? or just a quick flip for a bunch of traders? why the upswing here?
thanks all
LITTLE BLUE SKYE BREAK OUT MUSIC... KICK START MY HEART..
NMUS->EMBI->SKYE-> Moon let's goo!!!!
JUST BEAUTIFUL
UP 100%+ SINCE LAST WEEK
The 1 analysts offering 12-month price forecasts for Skye Bioscience Inc have a median target of 2.00, with a high estimate of 2.00 and a low estimate of 2.00. The median estimate represents a +1,566.67% increase from the last price of 0.12.
Today’s upgrade from Stockinvest:
Is Skye Bioscience, Inc. stock A Buy?
Skye Bioscience, Inc. holds several positive signals and despite the stock being in a falling trend, we considered it to be a good choice at these current levels. We expect Skye Bioscience, Inc. stock will perform very well in the next 3 months. We have upgraded our analysis conclusion for this stock since the last evaluation to a Strong Buy Candidate candidate.
Closed up 26.4% on 4,200,000 shares
Something is up. Bring the news
NICE CLOSE TODAY FOR SKYE.. GOOD VOLUME ALSO.. SEEMS MORE PEOPLE BECOMING INTERESTED IN SKYE..
BOOM....If we can get some new eyeballs on SKYE, we should move positively.
https://ir.skyebioscience.com/news-events/press-releases/detail/112/skye-biosciences-thcvhs-demonstrates-superior
I feel you... Dutch Paul... Market makers are shaking the tree here hard...
Sell higher, you cunts!
Great opportunity to add to your position more bang for your buck... If you look at the Chart history these prices are a steal...
0.1240 NICE CLOSE FOR SKYE TODAY... Consolidating beautifully...
Nothing we can do... SKYE did this 0.03 0.05 0.08 and now 0.11.... It will trade sideways until the company releases news or big news from the government is released... When it does break out it'll be good...
we need some action!
This has been floating around several boards I've seen, thought it was worth a share.
"From Million Dollar Investments Twitter:
"SEC rule requiring shorts to have cash on hand in order to borrow, and brokers to have cash on hand to cover any lent shares goes into effect Thursday. After Wednesday they are forced to cover or recall shares loaned that cannot be covered.
Expect the MM's to be vicious until they are forced to cover or recall shares loaned that cannot be covered. Bleeding should stop in the OTC soon..." "
Hope we'll see more good movement soon!
Here's a link to the SEC's statement:
https://www.sec.gov/news/public-statement/staff-fully-paid-lending
CNN CANNABIS STOCKS ARE HOT... THE BULL RUN IS JUST BEGINNING... https://www.cnn.com/2021/04/20/investing/cannabis-stocks-420/index.html
Senate majority leader say Marijuana decriminalize by 4/20/2022... https://www.cnbc.com/2021/04/20/schumer-calls-for-marijuana-to-be-decriminalized-by-next-years-420.html
TECHNICAL analysis for SKYE 100% Buy for 4/20... SHORT/MEDIUM/LONGTERM.... https://www.barchart.com/stocks/quotes/SKYE/opinion
Sequire Conference today: 1. IOP data to be released before end of the quarter and 2. New competitive data (latanoprost + Rhopressa) to be released before end of quarter. With both expected to be positive, expecting a share price bump when announcement is made sometime in the next 70 days.
Give a little pasta towards 0,13
TODAYS TECHNICAL OPINION SKYE 100% BUY!! SHORT ,MEDIUM AND LONGTERM... https://www.barchart.com/stocks/quotes/SKYE/opinion
Cannabis Market can be Brutal in the Summer.. Prices from May to August could get hammered.. But for the Patience investor who has cash at the ready will load big for cheap in many Cannabis stocks including SKYE and rebound in the fall or Santa Rally.... Just letting everyone know don't get discouraged take advantage... As far as SKYE goes its has been under alot of company ticker symbols and usually holds up well... I've been trading for quite few years and I've been through some nasty Summers just a heads up...
Head of Regulatory Affairs and Quality Assurance position just listed:
https://www.linkedin.com/jobs/view/2484364403
Indicators have SKYE As a Strong Buy... https://www.barchart.com/stocks/quotes/SKYE/opinion
April 8, 2021 01:09 PM ET (BZ Newswire) -- Cannabis
Skye Bioscience Inc. was a sponsor at the Benzinga Cannabis Capital Conference on February 25-26, 2021. The information contained in this article in no way represents investment advice or opinion on the part of Benzinga or its writers and is intended for informational purposes only.
From the first research of tetrahydrocannabinol(THC) in 1964 by Raphael Mechoulam to the recent findings of the hundreds of cannabinoids that can alleviate symptoms of a plethora of illnesses and diseases, we now know cannabis is more than just weed and about getting high.
Skye Bioscience Inc. (OTCQB:SKYE), a biopharmaceutical company developing proprietary, synthetic cannabinoid-derived molecules to treat diseases with significant unmet needs recently presented at the Benzinga Cannabis Capital Conference its approach to treating Glaucoma through unlocking the pharmaceutical value of THC.
Here’s what you need to know.
Glaucoma — An Important Unmet Need
According to a report on vision by the World Health Organization (WHO), at least 2.2 billion people suffer from vision impairment or blindness, of which over 1 billion cases could have been prevented or have yet to be addressed.
Glaucoma is a disease that leads to the progressive damage of retinal ganglion cells, which make up the optic nerve, and without intervention will gradually lead to irreversible blindness. In most cases, there is no pain and the loss of vision occurs gradually from peripheral to central and unfortunately, in many instances, people with glaucoma do not even realize it until they start experiencing some degree of permanent loss of vision
In fact, over 3 million Americans have glaucoma but only half of those know they have it. In addition, this disease accounts for over 10 million visits to physicians per year in the United States, and the estimation of suspected cases are close to 60 million worldwide.
of irreversible blindness and it ranks among the main reasons for the usage of medical marijuana.
A Light In The Horizon — Relevance Of THC To Glaucoma
The primary aim for currently used therapies is to lower intraocular pressure (IOP) to slow the progression. Yet, many patients are unresponsive or develop tolerance to medication leaving notable unmet needs, resulting in more than 50% of patients requiring 2 or more drugs which can increase side effects and reduce compliance. The market has lacked significant innovation, thus presenting an opportunity and need for new classes of therapy.
Cannabinoids have a great impact on the endocannabinoid system (ECS) — eyes are rich with cannabinoid receptors, specifically in tissues involved in managing fluid production and drainage as well as cells responsible for vision.
Multiple independent studies have demonstrated THC’s ability to lower IOP. In fact, the first report that smoking cannabis lowers IOP appeared in the early 1970s, and since then multiple human studies have validated THC’s ability to lower IOP. However there have been challenges creating a viable therapeutic with systemic delivery of THC for glaucoma because of poor,unpredictable pharmacokinetics and potential side effects.
Unlocking the therapeutic value of THC
Skye’s approach is designed to provide advantages over currently approved drugs and natural cannabinoids to treat glaucoma. Skye’s synthetic THC prodrug called THCVHS is engineered to enhance its local delivery — avoiding systemic side effects and enhancing bioavailability in the eye.
In an animal study comparing latanoprost, the glaucoma standard-of-care, THCVHS was superior in a key outcome of lowering IOP. THCVHS may also provide unique neuroprotection to prevent another key cause of vision loss — optical nerve cell death.
Skye is working toward its Phase 1 study planned for H2 2021, which will primarily assess safety and tolerability but will also measure IOP in both healthy subjects as well as a smaller subset of patients with elevated IOP. The nature of glaucoma allows this study to be relatively short and low cost.
Corporate highlights
Skye Bioscience, previously Emerald Biosciences, introduced a series of incoming results from pre-clinical and clinical-enabling studies. Should the results prove positive, they would pave the way for an Investigational New Drug (IND) application into what is a potentially $10 billion drug market.
Some of the company’s highlights include:
Demonstrated greater IOP lowering than market-leading glaucoma therapeutics
Potential neuroprotection capabilities would be a game-changer
Key preclinical data (IOP/neuroprotection) in Q221
First clinical trial: fast; low-cost; will include assessment of intraocular pressure
Many glaucoma licensing deals have been completed in phase 2 or earlier
$40 million market cap
$350 million outstanding common shares
$472.7 million fully diluted shares
Copyright © 2021 Benzinga (BZ Newswire, http://www.benzinga.com/licensing). Benzinga does not provide investmentadvice. All rights reserved. Write to editorial@benzinga.com with any questions about this content. Subscribe to Benzinga Pro (http://pro.benzinga.com).
Ready for the launch?
hey thank you. I still own GWPRF
and I also own CARA
just waiting on this one now
those other 2 are unicorns
Good to see you here.. I Remember you from #GWPRF and #GWPH... You were spot on..
this will RUN as soon as news hits. Been in this stock since the Nemus days.
It still is very unknown and undervalued
I am patient and my shares are free after trading my position
LONG SKYE
Schumer says bill to legalize marijuana Federally will be filed shortly... https://www.marijuanamoment.net/schumer-says-bill-to-legalize-marijuana-federally-will-be-filed-shortly/
WAKE UP OVER HERE... QUIT NAPPING ON THE JOB BOB...
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Our lead candidate, THCVHS, a proprietary prodrug of tetrahydrocannabinol (THC), is a topical formulation under development for the treatment of glaucoma and ocular hypertension (OHT).
Previous US government studies in humans discovered that THC was able to reduce intraocular pressure (IOP), which is in part responsible for the crush-like injury to the cells of the optic nerve that can eventually result in blindness. Additional preclinical studies have shown the potential for THC to also provide neuroprotective benefit, which may be especially important to patients with glaucoma who are experiencing disease progression with normal IOP levels.
One of the major drawbacks of previous studies of the use of THC for glaucoma was that they relied on inhalation or ingestion of THC. These systemic routes of drug administration cause negative side effects like psychotropic effects and potentially decreasing blood pressure , which resulted in the American Academy of Opthamology determining that the adverse effects of systemic cannabis administration/consumption outweighed its therapeutic benefit.
At Skye Bioscience, we chemically modify THC to create a unique synthetic molecule with the intent to safely realize the known positive effects of THC. Our molecule enables enhanced local delivery in the eye, reduced systemic side effects, and the potential for neuroprotection for the treatment of ocular diseases.
Glaucoma is a group of eye diseases that can cause vision loss and blindness by damaging a nerve in the back of the eye called the optic nerve. Damage to the optic nerve is caused by increased intraocular pressure (IOP) due to improper drainage and/or overproduction of fluid in the eye.
According to the American Academy of Ophthalmology, glaucoma affects over 75million people worldwide and is the leading cause of blindness in adults aged 60 and older.
Current therapies can lower IOP but progressive tolerance requires switching or combining drugs. They do NOT provide neuroprotective capabilities.
In preclinical studies, Skye’s THCVHS demonstrated the potential to significantly reduce intraocular pressure (IOP) – exceeding the capabilities of leading commercialized drugs in the current glaucoma market.
Additionally, it has been demonstrated:
We develop novel and proprietary classes of synthetic molecules through the modification of naturally derived systems.
Shifting the solutions paradigm on a effective treatment of diseases through the development of novel neuroprotective solutions.
Science First
The foundation of Skye Bioscience.
Revolutionary Solutions
Solving unmet needs of diseases with limited treatment offerings.
Product-led
Commercial differentiated applications to provide therapeutic benefits.
Impact driven
Change makers. Platform solutions that can extend beyond a single disease.
Mr. Dhillon was the co-founder, CEO, and director of OncoSec Medical Inc., a leading biopharmaceutical company developing cancer immunotherapies for the treatment of solid tumors.
Mr. Diep brings more than 15 years of scientific and clinical research experience to Skye Bioscience. Prior to joining Skye, Mr. Diep was at Protox Therapeutics Inc.
Richard has more than 30 years of business experience and served as a Vice President to CFO on multiple companies in a wide range of industries both public and private, domestic and international.
Mr. Kim serves as the General Counsel and Director of IP at Emerald Bioscience. He is an experienced biotech executive and corporate attorney, and a registered patent attorney.
Karam Takhar serves as Vice President, Corporate Development & Investor Relations at Skye Bioscience Inc. Prior to joining Skye, Mr. Takhar was at Emerald Health Sciences.
Mr. Dhillon was the co-founder, CEO, and director of OncoSec Medical Inc., a leading biopharmaceutical company developing cancer immunotherapies for the treatment of solid tumors.
Mr. Heppell is the co-founder, President and Director of BC Advantage Funds (VCC) Ltd., a venture fund that invests in and builds technology, life science and clean technology companies.
Dr. Dalesandro is the President of Brecon Pharma Consulting, a full-service biotech consultancy firm focused on identifying and obtaining critical information early in product development.
Dr. Muñoz is a Professor of Immunology in the Department of Cell Biology, Physiology, and Immunology of the University of Córdoba, Spain.
Dr. Pasquale is a Professor of Organic Chemistry, Department of Pharmaceutical Sciences at the University of Eastern Piedmont, Novara, Italy, where his research activities focus on isolation ..
Dr. Goldberg is the Professor and Chair of Ophthalmology and Director of the Spencer Center for Vision Research at the Byers Eye Institute at Stanford University.
Dr. Pasquale is the Professor of Ophthalmology at the Icahn School of Medicine at Mount Sinai in New York City.
Dr. Ritch holds the Shelley and Steven Einhorn Distinguished Chair in Ophthalmology and is Clinical Professor of Ophthalmology at the Mt. Sinai Medical School and Surgeon Director Emeritus.
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