Cybin (NYSE: CYBN), a biotech company in the psychedelics space, began listing its stock on the New York Stock Exchange on Thursday.
The company is the first in the sector to enter the NYSE, following a trend of five psychedelics companies to debut on the Nasdaq since the beginning of the year.
“This validation by the NYSE is incredibly humbling,” said CEO Doug Drysdale in an exclusive interview with Benzinga. He added that the listing provides a real opportunity for increased awareness as well as for growing the company’s shareholder base, especially among retail investors.
Cybin is developing a pipeline of novel psychedelic molecules for the treatment of diverse mental health indications, including a proprietary formulation of psilocybin (the active ingredient in so-called “magic mushrooms”), currently in phase 2 clinical trials.
‘Always Nice To Be First’
While the Nasdaq has so far been the only major U.S. exchange to receive companies from the psychedelics sector, Drysdale said the NYSE felt like a more natural fit for his company, as many of its partners are already listed there.
“It's always nice to be first doing something, but that's not really the reason we chose the New York Stock Exchange,” he said.
The CEO added that the exchange is eager to welcome more drug development and technology companies among its lists.
Cybin will continue to offer its shares in Canada through the NEO Exchange, and uplist its U.S. OTC shares (currently under the symbol 'OTCQB: CLXPF') to the NYSE American.
Cybin’s Flagship Program At A Glance
Cybin is laser-focused on drug development, leaving other lines of business within the psychedelics ecosystem to other players in the space.
“We have several programs underway, and a lot of milestones coming up,” Drysdale said
The company’s flagship program is a proprietary delivery method for psilocybin, in the form of a sublingual film called CYB001, which is targeting major depressive disorder.
In May, Cybin received approval to launch a phase 2a clinical trial that will test the company's formulation against a 25mg psilocybin capsule on 40 patients.
“The concept behind the film is that it's loaded with [psilocybin] and is placed under the tongue, where it's in touch with the sublingual membranes above and below. The goal with this is to deliver psilocybin very quickly, right into the bloodstream and quickly to the site of action without having to go through the guts, without having to go through the liver,” Drysdale explained.
If successful, the research will continue in a Phase 2b trial on 120 patients, where the safety and efficacy of the product will be assessed.
With the sublingual film, the company is hoping to see a rapid onset of action and possibly a shorter duration because bypassing the liver means using far less active substances to achieve the same effects.
This thesis will be tested in the Phase 2a trial, which should output its result by the end of the year.
Cybin is not the first nor the only company in the psychedelics space to launch clinical development on psilocybin for depression. Both Compass Pathways (NASDAQ: CMPS) and nonprofit Usona Institute have ongoing phase 2 trials testing psilocybin for this indication, though they’re using an orally administered version.
If Cybin can prove that its formulation offers improved benefits against orally administered capsules, the product could gain a competitive edge against other psilocybin options even though it is lacking the first-mover advantage.
“These are large markets that we're working in. Depression, anxiety and alcohol use disorder, they’re very large markets with huge unmet needs. Maybe seven or eight hundred million people globally are impacted by these,” says Drysdale.
Novel Psychedelics For Alcohol-Use Disorder And Anxiety
The company also has other molecules in the works, which are currently in late-stage preclinical trials. CYB003 and CYB004 are proprietary psychedelic molecules aimed at alcohol-use disorder and anxiety disorders, respectively.
The molecules are currently being studied in large animal models.
With these molecules, the company was able to take existing serotonergic psychedelics, and alter their duration of action without modifying either receptor binding or toxicology profiles.
“We've modified them through dueteration. So we've switched out some of the hydrogen atoms for deuterium. And the reason we've done that, is we’ve taken really, really short-acting tryptamines that last maybe 10 or 15 minutes, we've made them a little bit more tolerable, forty five minutes to an hour.”
While the chemistry of these molecules has not been released, based on their description, we can speculate that the initial molecules used in the development of these novel compounds were either DMT or 5-MeO-DMT.
The company hopes to see something that fits in with a regular clinic treatment paradigm, longer than DMT, but shorter than orally administered psilocybin.
The CEO expects CYB003 to begin clinical trials for alcohol use disorder around the first quarter of next year, and CYB004 in the second quarter.
On Tuesday, the company closed an overnight public offering of approximately 10 million shares, which raised CA$34 million ($27 million). To date, Cybin has raised over $95 million and has a market cap of $477 million.
On its last earnings call, Cybin announced cash and cash equivalents totaling CA$64 million ($51 million) as of March 31, 2021. While the current cash position is not available, it is estimated that the company holds south of $78 million minus operational spendings since late March.
The CEO said the company is very well capitalized for “many years into the future.”
While Cybin already held a strong balance sheet before the last offering, Drysdale said that “drug development takes a long time and it’s expensive,” thus the need to be well-capitalized and hold a strong balance sheet becomes obvious.
“I've learned from my past that you take capital when you're able to and not wait until the last minute when you need it. So, we certainly didn't need capital at this time, but we knew we would need more at some point.”
Although the last raise meant issuing more stock, Drysdale said it was well-received by existing shareholders, who saw share prices double from $1.43 on June 1 to $3.02 at market close on Wednesday.
Partnering To Improve Research
Cybin boasts several strategic partnerships meant to improve its drug discovery process.
Though Drysdale says the company has no plans to build brick-and-mortar psychedelics-therapy clinics, he recognizes the need for a clinical infrastructure to advance psychedelic drug research.
“When I look at the pathway to market, and not just commercial distribution in the future, but all the steps along the way that we have to take to develop these drugs through phase 2 and phase 3 studies, that requires a pretty significant clinical infrastructure. It requires investigators and therapists and physicians and locations that are all experienced and knowledgeable of psychedelics.”
With an exclusive research and development agreement with Greenbrook TMS Inc. (TSX: GTMS) (NASDAQ: GBNH), a company that operates 129 outpatient mental health service centers in the United States, Cybin has the potential to access an extensive patient base to advance clinical research on its compounds while facilitating the recruitment of participants for upcoming trials.
“The goal with Greenbrook initially is to create a few centers of excellence where we can tap into their vast knowledge of delivery of care in depression. We can bring in our 'Embark'
psychotherapy program with trained therapists, and then we can set up these pilot clinics that are models for future studies and future distribution.”
A partnership with Kernel, a brain imaging company, will allow Cybin to gain a better understanding of the brain under the influence of psychedelics.
Kernel has developed a wearable device called Kernel Flow, which offers a non-invasive brain interface.
“This is really the first time that anyone's been able to miniaturize this kind of neuroimaging technology. And our hope is that we can be able to see real-time brain activity during this psychedelic treatment session. And maybe from that, we can learn about how to better target these molecules in the future.”
Cybin is also co-sponsoring a clinical trial, in partnership with the University of Washington in Seattle, that will test the benefits of psilocybin treatment in health workers experiencing COVID-related distress.
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