•Canada-based biopharmaceutical company working with a network of partners and scientists to create therapeutics for patients to address a multitude of mental health issues
Company is focused on progressing Psychedelics to Therapeutics by engineering proprietary drug discovery platforms, innovative drug delivery systems, novel formulation approaches and treatment regimens for mental health disorders.
Products in pipeline include EMBARK, Kernel Flow, CYB003 (Deuterated Psilocybin Analog), CYB004 (Deuterated Dimethyltryptamine), and CYB005 (Phenethylamine Derivative)
CAD$29.93 million in cash and equivalents right now, its TTM cash burn of CAD$51.52 million means that it will need to raise more capital sometime in the next year, currently has zero debt
Currently, it has an at-the-market equity program which it can use to issue new shares worth up to CAD$38.4 million. That’d give it a total of CAD$68.33 million in cash, which would be sufficient for at least a bit more than an additional year of operations.
Awarded Psilocybin Company of the Year at the Second Annual Microdose Awards, recognizing Cybin’s leadership in innovating psilocybin-based therapeutics and commitment to improving the lives of patients. The award marks the second year in a row Cybin was awarded a Microdose Award as voted on by the psychedelic industry.
Strengthened the Company’s IP through the strategic acquisition of an exclusive license to a targeted catalog of psychedelic-based compounds from Mindset Pharma Inc. Cybin continued to strengthen its intellectual property portfolio that now includes access to over 35 patents and applications across 6 patent families through internal filings and licensing arrangements.
Upcoming Catalyst
CYB003 (Phase 1/2a ) has demonstrated several key advantages over oral psilocybin in preclinical studies, including faster onset of action, shorter duration of effect, and less variability in plasma levels. The Company expects to provide an interim safety and pharmacokinetic readout from the trial in early 2023.
The CYB004-E studyevaluating IV N,N-dimethyltryptamine (“DMT”)is expected to yield essential safety and dosing optimization data that will inform further clinical advancement of CYB004 (deuterated DMT) for the treatment of anxiety disorders. To date, the trial has completed dosing of four out of five cohorts with no clinically significant safety or tolerability issues. In April 2022, the Company announced positive preclinical data demonstrating the significant advantages of CYB004 over intravenous and inhaled DMT, including rapid onset and longer duration of action. Cybin expects to provide an update on the Phase 1 CYB004-E study in the first quarter of 2023.
CYB003: 40 participants, hence no additional risk increase for the play
Exploratory trial (CYB004-E trial): 50 Participants, the Safety Review Committee has confirmed no clinically significant safety or tolerability issues so far, hence no additional risk increase for the play
The Company plans to provide an update on the CYB004-E trial and the CYB004 program at its virtual R&D Day on February 28, 2023.
The Company plans to provide an interim readout from the Phase 1/2a trial at its virtual R&D Day on February 28, 2023i. The interim readout is intended to provide an initial understanding of the safety and PK profile of CYB003 in humans, including preliminary observations related to the psychedelic effect and duration of psychedelic effect of CYB003. These findings will help provide the necessary dose ranging information for the ongoing Phase 1/2a trial in addition to future clinical studies evaluating CYB003.
CYBN announced on Tuesday, Feb 14, their financial results for its third quarter ended December 31, 2022, couple of highlights:
Data Readout: Company expects to provide an interim readout from the ongoing Phase 1/2a trial evaluating CYB003 for the potential treatment of MDD, an update from the ongoing Phase 1 CYB004-E trial evaluating IV DMT and an update on its CYB004 program for the potential treatment of GAD.
Patent: Cybin secured a U.S. composition of matter patent covering CYB004 in February 2022 that provides patent protection through 2041. The patent covers a range of deuterated forms of DMT and protects CYB004 as a putative new chemical entity.
Financials: Cash totaled C$22.5 million as of December 31, 2022, and C$20 million as of February 14, 2023. Cash-based operating expenses totaled C$11.1 million compared to C$12.0 million in the same period last year. Cash flows used in operating activities were C$10.8 million for the quarter ended December 31, 2022, compared to C$12.8 million in the same period last year = indicates a year-plus of cash runway.
Analyst Perspective (Canaccord Genuity)
We are making some adjustments to our model (mainly expenses) and factoring a modest C$10mn raise (at the current stock price) in F4Q23 (Mar-23). We continue to only include value for CYB003 in major depressive disorder (MDD) at a probability of approval assumption of 33% with an assumed launch in F2028E. Our peak unadjusted US sales estimate is unchanged at C$3.7bn in F2034E. We continue to model no specific contribution from CYB003 in alcohol-use disorder (AUD), CYB004 (deuterated DMT for GAD) and CYB005 (phenethlyamine derivative for neuroinflammation). Our DCF-based price target remains at US$7.
Position: Shares 50% up from the call out. Will start to take profit / cover cost basis a week before the catalyst.
Even if the R&D Day on Tuesday is from 10:00 a.m. ET to 11:30 a.m. ET, I expect a press release today after hours or tomorrow pre-market. So today is the last day to cover CB / secure profits.
I appreciate the information you have shared here about CYBN.
It is the top holding in the PSIL ETF that I have been accumulating over the past couple of years. I am buying PSIL because I believe there will be a revolution in the way the general public perceives these compounds. Picking who will be the winners in 5 - 10 years seems rather difficult at the moment. The Daily had a episode earlier this week on the topic: https://www.nytimes.com/2023/02/22/podcasts/the-daily/veterans-psychedelics-legalization.html
CYB003 Phase 1/2a interim data demonstrate rapid and short-acting effects; robust psychedelic effects at low doses; positive safety and tolerability profile; top-line efficacy data expected late Q3 2023 -
- Initial findings from Phase 1 CYB004-E study suggest IV DMT was well-tolerated; study design expanded to accelerate first-in-human dosing of CYB004 -
Interim findings aligned with the pre-clinical outcomes, no issues in terms of safety profile, top-line result in late third quarter of 2023. I believe we will see red today as these interim findings are already priced-in (85% run up since the call out) and there was an expectation that more robust and comprehensive data will be shared.
Position: Most likely I will keep my remaining shares (avg 0.29) for the top-line data read out in Q3.
The only new data point out of their R&D day is that they introduced key amendments to study design to include:
Introduced Healthy Volunteers (HVs) for lower (sub-therapeutic) dose cohorts
Added bioequivalence (BE) and food effect cohort to allow swift transition to pivotal studies
Dose-response cohorts to select optimal dose for pivotal studies
I believe they are doing this to move directly from this study to a pivotal phase 3 study which will be the basis for the new drug application to the FDA.
