In this edition of "Rising High," The Fly conducted an exclusive interview with David Johnson, chairman and chief executive officer of Enveric Biosciences (ENVB), a biotechnology company developing novel cannabinoid medicines for cancer patients. Here are some of the highlights:
SUPPORTIVE CARE: Enveric Biosciences is a patient-first biotechnology company focused on cannabinoid therapeutics to improve quality of life for cancer patients. The company started trading on the Nasdaq Exchange on December 30 through a reverse merger of a private company called Jay Pharma. “Jay Pharma was originated about two and a half years ago through a licensing agreement in the world of oncology from a company in Israel called Tikun Olam,” Johnson said. “It’s significant in that Tikun Olam was a key participant in an Israeli government registry study on using cannabis in a number of different health indications to determine whether there was efficacy.” He added the study was directive in nature on where more research needed to be done. “It was really through this data set, that we were able to have a better understanding of some of the opportunities that may exist in the world of cannabinoid therapy and oncology indications,” the CEO said. “That really started us about a year ago, moving down the road on where does the data suggest there’s a high probability of strong results if the right product formulation was put together.” This led to the company focusing on the supportive care area of cancer, he said, which in essence is the side effects of patients who have gone through cancer treatments.
“We think that there is just this huge unmet medical need and a standard of care which is just not doing it for patients today,” Johnson said. “It’s such a critical component to patients who live with this after they actually are cured or at least looked after through their kids or therapy. It’s really with that background that we are building novel prescription drugs for the side effects of cancer therapy.” He said Enveric is exploring cannabinoidal medicines as well as potential other opportunities within the space. “We’re developing or identifying undervalued/underresearched naturally occurring compounds,” he said. “We will research these compounds in partnership with leading clinics and plan to target leading pharmaceutical and biotech companies that can leverage the commercialization capabilities as we move this forward.”
COMPETITIVE EDGE: When asked about the rising competition in the space, the CEO said Enveric keeps a keen eye on any development work being done in the space, but the competition is currently the conditions itself. “What we need to do is focus in three specific areas starting with utilizing a sophisticated product development process with strong scientific rigor,” he said. “Really leveraging the biotech model over the years but utilizing cannabinoidal therapy to come up with strong products that can be patent-protected and add some strong intellectual property to the portfolio.” Johnson said the company will execute this through its second focus, partnerships with world-class academic and oncology centers around the world and with leading physicians and researchers to study these products in human trials through the FDA process.
“Finally, while we’ll do a lot of internal work and internal development, we’ll also utilize what I like to say is our public currency to effectively expand in other opportunities for some strategic transactions,” he said. “That could be licensing or it could be acquisitions. While we’ll look at industrial competition and we’ll collaborate with some of that competition in the development of some of these drugs, this is really about executing effectively with the kind of rigor and sophistication in the development world that has gone on for years in the biotech industry.”
INITIATIVES: Enveric is currently in preclinical development for medicines for radiodermatitis and glioblastoma and in the discovery phase for chemotherapy-induced peripheral neuropathy. Johnson said the company is currently awaiting Israeli Ministry of Health approval for its GBM Phase 1/2 study and once it has received that, it will move to enroll the first patient in the trial. “We’re very encouraged about the team, the primary investigator and the work that’s been done in creating the product to get to the space,” he said. For Enveric’s radioderm initiative, the company is collaborating with a leading oncology center in the U.S., the CEO said, and both parties have identified and agreed upon a primary investigator. “We are working with them through the formulation of the product, the pre-IND support work that needs to be done and more information should come out with that soon.” He added the company has also identified the appropriate center and a primary investigator for its CIPN initiative but is a little further behind in regards to some of the other work. “We’ll continue to augment these three in the world of business development as we see vehicles to expand indications or expand intellectual property opportunities.,” he said.
GW PHARMA TAKEOVER: On February 3, Jazz Pharmaceuticals (JAZZ) announced it would acquire GW Pharmaceuticals (GWPH) for $220.00 per ADS and Johnson said the deal was music to his ears. “It’s just added the appropriate legitimacy to cannabinoidal medicines and therapeutic solutions that they provide,” he said. “I think that GW was able to progress the company to where it is, not just with Epidiolex, but with a number of other pipeline products really all around the central nervous system.” The CEO added looking at Jazz and their path in the rare and complex diseases, the two companies just fit nicely together. “It’s the first time the traditional pharmaceutical or biotech world has dipped their toes into the water into other therapies and cannabinoidal therapy has been recognized for many years as the potential adjunct to other therapies,” he said, noting GW received FDA approval in June 2018 and recently announced preliminary Q4 revenue of $148M. “What it tells you is that a, the regulators we’re right to approve this product, b, patients and families of this very challenging disease have had open hearts and open appetites to try it and use it and c, if it continues to grow, it continues to be demonstrated that it’s helping these young children and their families in dealing with this,” he said. “I think we’ll find the politicians continuing to open their minds into how this therapy is helping patients and more importantly how it can continue to help patients moving forward.” Johnson said the transaction is a huge step for the industry as a whole. “Congratulations to GW on putting together a first-class organization that can be a beacon for all,” he said.
LEGALIZATION: When asked about the potential federal legalization of cannabis in the U.S., the CEO said it’s difficult to estimate but he is very encouraged by the discussions and public comments around the industry. “There are a number of progressive ideas which would enable the industry to move in some very positive ways and so for that, I think we should all be extremely excited,” he said. “Net, this is a very large upside to the industry, which will be a catalyst to continue to allow it to grow and to continue to allow the regulators to look at it in the most appropriate ways.”
CORONAVIRUS: The coronavirus pandemic has impacted many companies in the industry globally and Johnson said he has seen a number of changes related to the outbreak. “It has emphasized the need and quite frankly the importance of a robust, strong and resilient biotech industry, whether that’s in the world of diagnostics or drugs or vaccines,” he said. “I think if there has never been before a layman’s acknowledgement of the good that our industry does and the need for it, the coronavirus has brought it to every last part of this land.” The CEO said he also thinks the accelerated ability to get vaccines on the market demonstrates that strong open collaboration between governments, regulators, academics and industry to create a more efficient process to get drugs to the market faster. “There will be some lessons learned when the cloud goes away,” he said, “To be able to take a step back and say, ‘What did we learn and what can we integrate into processes moving forward that will help our industry get products to the market in a much more efficient way through capital, through human talent, and through the regulatory corridors without at any point giving up on clinical efficacy?” Johnson said he is not sure he has the answers, but the industry needs to move in that direction. He added coronavirus has also made the public more aware of globality. “In looking at the coronavirus and looking at how some governments are believing we should be looking inward and not outward, I do think the coronavirus has made us recognize that there are no borders when it comes to disease or pandemics,” he said. “As we go forward with drugs and diagnostics and vaccines, we need to look for global solution.”
CHALLENGES: When asked about the biggest challenges facing the industry, the CEO pointed to the regulatory confusion surrounding the space. The U.S. has come a long way from a regulatory perspective in the last five years, he said, adding Canada has clearly moved faster and taken larger steps. “We have an industry where there are potentially opportunities for moving forward in a faster, more efficient way,” Johnson said. “It’s difficult from a regulatory perspective when one state does it one way and one state does it another way.” He also noted the complex restrictions surrounding hemp around its legalization. “There are still many things you can and can’t do by state and across border from state-to-state,” he said, citing restrictions on where clinical trials can take place and what can be used. “I think I speak for many of my colleagues in the sector, we’re looking for collaboration and guidance so when we’re making investment decisions, we can be assured that these investment decisions are moving in the way that regulators want us to be,” he said. “There have been times where that has been confusing so consistency in understanding where the future lies will help this industry greatly.”
OPPORTUNITIES: As the cannabis space develops, Johnson said Enveric is excited about the potential to develop therapeutics for unmet medical needs in support of care indications where patients are not living the quality of life they would like to. “Our ability to develop novel therapeutics which help these patients and their families each and every day live a better quality of life, that’s what we get up in the morning and we get excited about,” he said. “I got into the lifesciences industry close to 40 years ago and I just stayed in it because what we do is we create longer and better lives for individuals.” The CEO added he couldn’t be more excited about the company’s moves in the last 45 days, which includes raising over $23M of capital to bolster its balance sheet. “We think we’re at a stage, with a strong balance sheet, a very clear direction, an outstanding team and a marketplace that is underserved,” he said. “We’re very excited about moving forward in this space.”
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).
