In this edition of "Rising High," The Fly conducted an exclusive interview with Punit Dhillon, chief executive officer of Skye Bioscience (SKYE), a biopharmaceutical company developing cannabinoid-derived molecules to treat diseases. Here are some of the highlights:
CANNABINOID-DERIVED MOLECULES: Skye Bioscience is a biopharmaceutical company focused on proprietary, synthetic cannabinoid-derived molecules to treat glaucoma and other diseases with significant unmet need. “We’re taking a unique approach of using cannabinoids, a different and new class of therapeutics, to help unlock the different applications and therapeutic potential of this type of class of drugs,” Dhillon said, adding the company has several approaches in development around two different molecules. The company’s lead program is focused around glaucoma, he said, as there are over 80 million patients affected by the disease creating a substantial market opportunity. “What’s worse is that it’s the leading cause of irreversible blindness,” the CEO said. “What we’ve been able to identify is that from the existing market perspective there are very limited options.” He said drugs are available for glaucoma patients but they are not necessarily working very effectively and patients can also get sensitization from those existing drugs, leading to a large population categorized as non-responders. “That’s a big opportunity for us to catch there in terms of ‘Is there a solution with a new class of therapy that can have an impact for these patients?’” Dhillon said. “What we have identified when we were formulating a development plan around our lead molecule is that there has been a certain body of research that shows that cannabis can help patients with glaucoma.” He noted that government studies that go back to the 70s showed that using THC lowered intraocular pressure for patients that had glaucoma. “When it was inhaled, it created the positive effect of lowering intraocular pressure but it also had some other side effects that would be expected,” he said, noting the psychoactive high and poor bioavailability. “What we’ve identified is we can solve for all of that by delivering a pharmaceutical-grade molecule directly into the eye and eliminating some of those adverse types of effects that people would experience with inhalation of THC.”
COMPETIVE EDGE: When asked about the company’s key differentiators, the CEO pointed to the nascent nature of the space as well as drug application. “What’s been really nice to see is that there have been some sections out there that have been able to validate the use of cannabinoids, GW Pharma (GWPH) being one of the biggest companies,” he said. “Through scientific rigor and going through the clinical process and regulatory process, they’ve been able to get FDA approval.” Dhillon said the move demonstrates the approach could be applied in a disease model, opening up a lot of opportunity. “This space is still very early and nascent,” he said. “We’re the only company that is developing a THC-based cannabinoid for glaucoma so there’s a limited number of players. That’s going to be a big component of it.” The CEO said the other differentiator, as with all pharmaceuticals, is being able to show how your drug can do something that others are not able to do. “In glaucoma, there’s a wide number of drugs that are already being used that are not very effective and there hasn’t been anything new available for patients,” he said. “This particular area is thirsty for new innovation and we’re going to protect that innovation with intellectual property so that’s the biggest kind of differentiator along with what the application of the drug can do.”
THCVHS, CBDVHS: THCVHS, a proprietary prodrug of THC, is Skye’s lead candidate and a topical formulation under development for the treatment of glaucoma and ocular hypertension. “Where we’re at in terms of the stage of development at this particular juncture is completing the clinical-enabling studies that would allow us to go into Phase I human trials,” Dhillon said. “There are some specific steps that are required, one is scaling up our manufacturing and the other is to complete the required regulatory preclinical studies.” He said the company expects to focus on completing the preclinical work in the first half of the year and plans to start the human trials in the second half of the year. “We are quite excited about being able to not only assess the safety and tolerability of our drug, which is the endpoint of this clinical trial that is planned, but we are also going to be looking at a small subset of patients with glaucoma that have elevated intraocular pressure,” he said. “We’ll be able to measure that reduction and effectiveness of our drug for those particular patients.” The CEO said Skye has shown that ability in animals so if it can recapitulate the data in humans, it will open up opportunities for the company. “The key thing in terms of a value inflection point for the company is being able to really see the effectiveness of our molecule in those patients with glaucoma and elevated intraocular pressure,” he said. CBDVHS, a proprietary prodrug of CBD, is an earlier-stage molecule in Skye’s development, Dhillon said. “We believe that we can leverage what we’re doing on the THC side moving forward in the ocular space by demonstrating the applicability of another molecule for another disease,” he said. “We’re very interested is exploring the application of CBD across other potential applications but it’s too early for us to suggest what that indication might look like. I think we’re going to be articulating what that development plan looks like later in this year.”
REBRANDING: On January 19, the company announced it had changed its name from Emerald Bioscience to Skye Bioscience and was trading under the new ticker symbol “SKYE” on the OTC. “The rebranding represents a new leadership team that’s come in,” Dhillon said. “There’s been quite a lot that has taken place over the last 120 days or so with the company.” He noted that he has recently come on as CEO and a new team has been appointed with individuals he has worked with in various capacities over the last two decades. “The new name is a new chapter for the company,” Dhillon said. “We’re excited about bringing our drug into the clinic and realizing the different applications of cannabinoids.”
CORONAVIRUS: The coronavirus pandemic has impacted many companies in the industry globally and Dhillon said while it is very tragic, it has highlighted a greater amount of cooperation amongst the healthcare and life sciences industry. “In terms of Skye, like all of us in the sector, we’ve tried to remain resilient,” he said. “We’ve adapted to this situation in the way we work with our collaborators, the way we work with our partners and internally as a staff.” The CEO added the company is still remaining virtual, but is quite confident it can achieve all timelines put forth for upcoming milestones. “We’re looking forward to dosing our first patient in Q3 of this year,” he said.
CHALLENGES: When asked about the biggest challenges facing the industry, the CEO cited the regulatory environment as well as the lack of research in the space. “There’s definitely one from a regulatory standpoint,” he said. “We’re working with a controlled substance in terms of the active pharmaceutical ingredient…you don’t always necessarily have that type of hurdle.” Dhillon added that regulation is a small obstacle but a bigger obstacle is research in the space. “Overall I think it’s just an understanding of the endocannabinoid system,” he said. “It’s a relatively nascent area in terms of research so far and that’s where the opportunity lies. As we have a better understanding of what those different pathways have in terms of cause and effect for different diseases and how these cannabinoids interact with the endocannabinoid system, it’s going to help have that science that backs the different therapeutic applications.” The CEO said he believes that challenge will go away over time as there is continued research in the area. “That’s a responsibility that we’re taking on as a pharmaceutical company that is going to continue to pave the way with intellectual property around two of the most important cannabinoids out there that have been identified,” he said.
OPPORTUNITIES: As the cannabis space develops, Dhillon said he is excited about what happens in the next twelve months in terms of execution at Skye. “Everyone is waiting for the ability for this molecule to get into human studies,” he said. “As a team we’re very excited about that. Showing that the existing data can be recapitulated and validated in human trials against glaucoma and it’s a solution for these patients would be tremendous.” The CEO said if the company can demonstrate that data, it will open up the floodgates for a lot of different opportunities for understanding the mechanism of different cannabinoids. “We’re excited about the impact that cannabinoids can make in terms of opening up a different class of molecules to a whole range of different applications,” he said. “It has the potential to be differentiated, it has the potential to be lower in cost and it has the potential to be impacting a whole range of different diseases. There’s quite a blue sky opportunity.”
CANNABIS STOCKS: Other publicly-traded companies in the space include Acreage (ACRGF), Akerna (KERN), Aleafia (ALEAF), Aphria (APHA), Aurora Cannabis (ACB), Auxly Cannabis (CBWTF), CannTrust (CTST), Canopy Growth (CGC), Canopy Rivers (CNPOF), CordovaCann (LVRLF), Cresco Labs (CRLBF), Cronos Group (CRON), CV Sciences (CVSI), CURE Pharmaceutical (CURR), Delta 9 (VRNDF), Emerald Health (EMHTF), FluroTech (FLURF), General Cannabis (CANN), Greenlane (GNLN), Green Thumb Industries (GTBIF), GrowGeneration (GRWG), Harborside (HBORF), Hemp (HEMP), HEXO (HEXO), IM Cannabis (IMCC), India Globalization Capital (IGC), Indiva (NDVAF), Indus Holdings (INDXF), Inner Spirit (INSHF), Innovative Industrial Properties (IIPR), Khiron Life Sciences (KHRNF), Liberty Health Sciences (LHSIF), MediPharm Labs (MEDIF), MedMen Enterprises (MMNFF), MJardin Group (MJARF), Neptune Wellness (NEPT), Omnicanna (ENDO), Organigram (OGI), Planet 13 (PLNHF), Sproutly (SRUTF), Stem Holdings (STMH), Sunniva (SNNVF), Supreme Cannabis (SPRWF), Valens (VLNCF), TerrAscend (TRSSF), Tetra Bio-Pharma (TBPMF), Tilray (TLRY), Trulieve (TCNNF), Village Farms (VFF), Vireo Health (VREOF), WeedMD (WDDMF), Wildflower Brands (WLDFF), YSS Corp. (YSSCF), Zynerba (ZYNE) and 4Front Ventures (FFNTF).