THCVHS shows no signs of chromosomal or gene mutations in preclinical studiesSAN 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 THCVHSTHCVHS, 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...

THCVHS shows no signs of chromosomal or gene mutations in preclinical studiesSAN 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 THCVHSTHCVHS, 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...

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...

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...

SAN DIEGO, CA, June 10, 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 expanded its Clinical Advisory Board with the appointment of ophthalmology expert and innovator, Miguel González-Andrades, MD, PhD."We are honored to have Dr. Miguel González-Andrades join our Clinical Advisory Board at a pivotal time for the company, specifically as we advance into the first-in-human study of our lead program, THCVHS for the treatment of glaucoma," said Punit Dhillon, Skye Bioscience CEO. "Dr. González-Andrades's extensive clinical experience and innovative work in the field of ophthalmology adds great value to our outstanding team of world-class glaucoma experts, and we look forward to his contributions as we advance our ocular development strategy." Miguel González-Andrades, MD, PhD is a clinician-scientist currently working as an ophthalmologist in the Ophthalmology Unit at Reina Sofia University Hospital, and as assistant professor and research scientist at Maimonides Biomedical Research Institute of Córdoba-University of Cordoba. Additionally, he serves since 2019 as an adjunct scientist at the Schepens Eye Research Institute and Mass Eye and Ear (SERI-MEEI), Harvard Medical School, after working there for five years leading different research projects on ocular biomedical engineering. Currently, he is the Chair of the Young Section of the European Society of Ophthalmology. During his clinical training and residency, Dr. González-Andrades focused his research on the construction of an artificial human cornea by applying tissue engineering techniques, obtaining his PhD Cum Laude in 2011 while serving as the coordinator for a multi-center phase I-II clinical trial evaluating artificial human corneas based on fibrin-agarose biomaterials.Dr. González-Andrades has been published in international journals such as Ocul Surf, Sci Rep, Biomaterials, and Nature Biomedical Engineering and has received numerous scientific awards, including the MIT Technology Review Spain - Innovators Under 35 Award and the Discovery Channel - Born to Be Discovery Award. He also received the Knights Templar Award from the Association for Research in Vision and Ophthalmology (ARVO), and the prestigious Claes Dohlman Fellowship Award that internationally recognizes outstanding fellows training...

SAN DIEGO, CA, June 10, 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 expanded its Clinical Advisory Board with the appointment of ophthalmology expert and innovator, Miguel González-Andrades, MD, PhD."We are honored to have Dr. Miguel González-Andrades join our Clinical Advisory Board at a pivotal time for the company, specifically as we advance into the first-in-human study of our lead program, THCVHS for the treatment of glaucoma," said Punit Dhillon, Skye Bioscience CEO. "Dr. González-Andrades's extensive clinical experience and innovative work in the field of ophthalmology adds great value to our outstanding team of world-class glaucoma experts, and we look forward to his contributions as we advance our ocular development strategy." Miguel González-Andrades, MD, PhD is a clinician-scientist currently working as an ophthalmologist in the Ophthalmology Unit at Reina Sofia University Hospital, and as assistant professor and research scientist at Maimonides Biomedical Research Institute of Córdoba-University of Cordoba. Additionally, he serves since 2019 as an adjunct scientist at the Schepens Eye Research Institute and Mass Eye and Ear (SERI-MEEI), Harvard Medical School, after working there for five years leading different research projects on ocular biomedical engineering. Currently, he is the Chair of the Young Section of the European Society of Ophthalmology. During his clinical training and residency, Dr. González-Andrades focused his research on the construction of an artificial human cornea by applying tissue engineering techniques, obtaining his PhD Cum Laude in 2011 while serving as the coordinator for a multi-center phase I-II clinical trial evaluating artificial human corneas based on fibrin-agarose biomaterials.Dr. González-Andrades has been published in international journals such as Ocul Surf, Sci Rep, Biomaterials, and Nature Biomedical Engineering and has received numerous scientific awards, including the MIT Technology Review Spain - Innovators Under 35 Award and the Discovery Channel - Born to Be Discovery Award. He also received the Knights Templar Award from the Association for Research in Vision and Ophthalmology (ARVO), and the prestigious Claes Dohlman Fellowship Award that internationally recognizes outstanding fellows training...

SAN DIEGO, CA, June 10, 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 expanded its Clinical Advisory Board with the appointment of ophthalmology expert and innovator, Miguel González-Andrades, MD, PhD."We are honored to have Dr. Miguel González-Andrades join our Clinical Advisory Board at a pivotal time for the company, specifically as we advance into the first-in-human study of our lead program, THCVHS for the treatment of glaucoma," said Punit Dhillon, Skye Bioscience CEO. "Dr. González-Andrades's extensive clinical experience and innovative work in the field of ophthalmology adds great value to our outstanding team of world-class glaucoma experts, and we look forward to his contributions as we advance our ocular development strategy." Miguel González-Andrades, MD, PhD is a clinician-scientist currently working as an ophthalmologist in the Ophthalmology Unit at Reina Sofia University Hospital, and as assistant professor and research scientist at Maimonides Biomedical Research Institute of Córdoba-University of Cordoba. Additionally, he serves since 2019 as an adjunct scientist at the Schepens Eye Research Institute and Mass Eye and Ear (SERI-MEEI), Harvard Medical School, after working there for five years leading different research projects on ocular biomedical engineering. Currently, he is the Chair of the Young Section of the European Society of Ophthalmology. During his clinical training and residency, Dr. González-Andrades focused his research on the construction of an artificial human cornea by applying tissue engineering techniques, obtaining his PhD Cum Laude in 2011 while serving as the coordinator for a multi-center phase I-II clinical trial evaluating artificial human corneas based on fibrin-agarose biomaterials.Dr. González-Andrades has been published in international journals such as Ocul Surf, Sci Rep, Biomaterials, and Nature Biomedical Engineering and has received numerous scientific awards, including the MIT Technology Review Spain - Innovators Under 35 Award and the Discovery Channel - Born to Be Discovery Award. He also received the Knights Templar Award from the Association for Research in Vision and Ophthalmology (ARVO), and the prestigious Claes Dohlman Fellowship Award that internationally recognizes outstanding fellows training...

SAN DIEGO, CA, June 10, 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 expanded its Clinical Advisory Board with the appointment of ophthalmology expert and innovator, Miguel González-Andrades, MD, PhD."We are honored to have Dr. Miguel González-Andrades join our Clinical Advisory Board at a pivotal time for the company, specifically as we advance into the first-in-human study of our lead program, THCVHS for the treatment of glaucoma," said Punit Dhillon, Skye Bioscience CEO. "Dr. González-Andrades's extensive clinical experience and innovative work in the field of ophthalmology adds great value to our outstanding team of world-class glaucoma experts, and we look forward to his contributions as we advance our ocular development strategy." Miguel González-Andrades, MD, PhD is a clinician-scientist currently working as an ophthalmologist in the Ophthalmology Unit at Reina Sofia University Hospital, and as assistant professor and research scientist at Maimonides Biomedical Research Institute of Córdoba-University of Cordoba. Additionally, he serves since 2019 as an adjunct scientist at the Schepens Eye Research Institute and Mass Eye and Ear (SERI-MEEI), Harvard Medical School, after working there for five years leading different research projects on ocular biomedical engineering. Currently, he is the Chair of the Young Section of the European Society of Ophthalmology. During his clinical training and residency, Dr. González-Andrades focused his research on the construction of an artificial human cornea by applying tissue engineering techniques, obtaining his PhD Cum Laude in 2011 while serving as the coordinator for a multi-center phase I-II clinical trial evaluating artificial human corneas based on fibrin-agarose biomaterials.Dr. González-Andrades has been published in international journals such as Ocul Surf, Sci Rep, Biomaterials, and Nature Biomedical Engineering and has received numerous scientific awards, including the MIT Technology Review Spain - Innovators Under 35 Award and the Discovery Channel - Born to Be Discovery Award. He also received the Knights Templar Award from the Association for Research in Vision and Ophthalmology (ARVO), and the prestigious Claes Dohlman Fellowship Award that internationally recognizes outstanding fellows training...

LOS ANGELES and TORONTO, June 11, 2021 (GLOBE NEWSWIRE) -- The Tinley Beverage Company (CSE:TNY, OTC:TNYBF) ("Tinley's" or "Company") is pleased to announce that it has closed a C$2.4 million private placement to advance its co-packing and branded product growth. Closing occurred on June 10, 2021.The Company continues to make capital investments to expand the scope of product formulation types and packaging formats that can be produced at its cannabis beverage manufacturing facility in Long Beach, California. The mini line and bottling lines have significant bookings in June and July, including third-party brands as well as manufacturing additional inventory of the Company's own products to fulfill dispensary demand. The commissioning of the canning line is currently expected to be completed this month, with initial clients currently slated to run in July. The heat tunnel pasteurization unit, for which there is already scheduled demand, is currently expected to be commissioned and running in July as well."We are delighted to continue our track record of primarily attracting quality institutional investors to our financings. We believe that this reflects increasing confidence in the growth of our co-packing client list and volumes and in our continued ability to obtain listings with marquee dispensaries and mainstream retailers," said Ted Zittell, Director of Tinley's.The non-brokered private placement ("Offering") resulted in gross proceeds of C$2,416,250 from the issue and sale of 7,321,971 units ("Units"). Each Unit has been purchased for C$0.33 and is comprised of one common share of Tinley ("Common Share") and one-half of one common share purchase warrant (each whole warrant, a "Warrant"). Each Warrant is exercisable into one Common Share ("Warrant Share") at a price of C$0.42 for a period of 24 months following the closing. In connection with this closing, Tinley paid finders approximately C$10,000 and issued aggregate of 29,750 broker units ("Broker Unit Options"). Each Broker Unit Option entitles the holder to acquire one Unit ("Broker Unit") at an exercise price of C$0.33 for a period of 24 months following the closing of the Offering, with each Broker Unit comprised of one Common Share and one-half of one Warrant. The Common Shares, Warrants...

LOS ANGELES and TORONTO, June 14, 2021 (GLOBE NEWSWIRE) -- The Tinley Beverage Company Inc. (CSE:TNY, OTC:TNYBF) ("Tinley's" or the "Company") is pleased to announce that its cannabis infused beverages will be one of the inaugural brands to launch at Planet 13's Orange County SuperStore "P13 OC" at its expected grand opening in July 2021.Planet 13's SuperStore OC, located at 3400 West Warner Ave Santa Ana, California, is planned as a 55,000 square-foot consumer experience, with 16,500 square-feet devoted to the dispensary retail area. The remaining areas in the complex, to be built as phases 2 and 3, are expected to include memorabilia sales, a restaurant and a cannabis consumption lounge, all enhanced by additional immersive experiences. With all 3 phases operating, P13 OC is expected to be California's largest dispensary complex. The Santa Ana store will be Planet 13's second-largest cannabis dispensary after its 112,000 square foot location in Las Vegas, Nevada. The Orange County location is ten minutes south of Disneyland, four miles from South Coast Plaza, the largest mall in Southern California, and only 1.5 stoplights from the 405 freeway. Planet 13 anticipates hiring 250 people with an anticipated 80 budtenders serving consumers at the store at any given time.The store's immersive cannabis educational and entertainment experiences incorporate extensive visual special effects, including "smoke", large screen video displays and waterfalls. Planned features include a Tinley's branded midcentury-inspired mixology experience involving beverage recipe demonstrations and, where permissible, tastings of comparably concocted non-infused products.Later this week, Tinley's is hosting approximately 80 of Planet 13's budtenders and other key personnel at the Company's cannabis beverage manufacturing facility in Long Beach, California, in order to provide the P13 OC dispensary team the in-depth product knowledge that Planet 13 is committed to deliver to customers. Tinley's believes its facility is the largest and most versatile licensed cannabis beverage manufacturing operation in California. Tinley's own award-winning products as well as those belonging to third-party brands are produced on the facility's bottling, canning and mini lines.Tinley's beverages won the #1 and #2 place awards at California's Emerald Cup, which is the world's largest cannabis competition,...

LOS ANGELES and TORONTO, June 17, 2021 (GLOBE NEWSWIRE) -- The Tinley Beverage Company Inc. (CSE:TNY, OTC:TNYBF) ("Tinley's" or the "Company") is pleased to announce that California's longstanding favourite cannabis beverage "Sprig" will produce at Tinley's bottling facility in Long Beach, California.Sprig was founded in Newport Beach, California, in 2015 and quickly became one of California's most prominent cannabis beverages. The company was founded with one goal: To make delicious, refreshing cannabis-infused sparkling beverages to the highest standards of major brands.Sprig also sells its hemp-derived CBD-infused beverages in stores and online nationwide. Working with Tinley's, Sprig is now re-introducing its award-winning THC-infused beverages—Citrus Original and Citrus Zero Sugar—to California dispensaries and licensed home delivery channels in 2021, after receiving significant interest from dispensaries and consumers for Sprig in its original THC format. The CBD versions will continue to be manufactured in third-party facilities as California law prohibits manufacture of hemp-derived CBD products in cannabis-licensed facilities.Sprig reports that since inception, consumers have purchased nearly 3 million cans of Sprig, and consumers will now be able to enjoy these products in both CBD and THC versions, with the THC version available in California through licensed dispensaries and delivery.Tinley's expects Sprig to be the first product to be produced on the Company's canning line, which is the third bottling line to be installed at its facility in Long Beach, California."Sprig has produced canned, carbonated cannabis drinks longer than any other brand," said Josh Rosinsky, Sprig's Vice President of Sales. "We're excited to be re-launching our THC products in California with Tinley's. Tinley 's shares our number one commitment: to produce the highest-quality products, to exacting safety and purity standards."A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/7d53df6f-7264-4f61-a17a-47870b74f0b5"Our canning line represents a significant additional source of production capacity. Together with our bottling and mini lines, and with our tunnel pasteurizer, our facility in Long Beach now offers a large variety of packaging, formulation and batching options for third-party brands," said Rick Gillis, President of Tinley's, Western USA. "We're excited for Sprig to be the first brand to run on this new canning equipment".About The Tinley...