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Docoh

Q3 Fiscal 2022 Earnings Call: https://docoh.com/transcript/1833141/2022Q3/CYBN

  • And we're pleased to announce that we have completed over 140 preclinical studies since beginning of 2021. The rate at which we're completing these important studies has escalated tremendously, with over 50 of these studies completed in January 2022 alone
  • As we've shared before, the World Health Organization estimates that mental health disorders affect more than 900 million people globally. Depression is widespread, with an estimated 800,000 deaths by suicide worldwide every year, and alcohol-related deaths worldwide account for another 3 million deaths. With this great need comes a large addressable market.
  • We're doing that by currently developing analogs and derivatives of psilocybin, DMT and other tryptamines and phenethylamines in order to turn these classical psychedelic molecules into approvable prescribable therapeutics.
  • CYB003, our most advanced candidate. CYB003 is a deuterated analog of psilocybin. Deuteration is simply substituting hydrogen atoms on these tryptamine molecules with deuterium, which is heavy hydrogen
  • And with our CYB003 program, we're targeting the treatment of major depressive disorder, or MDD, and alcohol use disorder, or AUD.
  • These studies have revealed that compared to traditional classical psilocybin, CYB003 may result in half the time in the clinic for patients and perhaps a reduced dose, potentially reducing the side effects and inter-patient variability
  • CYB004 is our proprietary deuterated version of dimethyltryptamine, more commonly known as DMT, that we are evaluating for the treatment of anxiety disorders.
  • As announced just yesterday, we were granted a U.S. patent covering CYB004 with protection out to 2041.
  • Another external program that we're very excited about is the company-sponsored feasibility study in collaboration with Kernel, evaluating its Kernel Flow quantitative neuroimaging technology to measure psychedelic effects on cerebral cortex hemodynamics
  • As of December 31, 2021, our cash and cash equivalents totaled $63.6 million
  • Our cash-based operating expenses totaled $12 million for the quarter ended December 31, 2021, of which $2.5 million were onetime nonrecurring costs. Noncash expenses for the quarter totaled $5.2 million for a total net loss of $17.2 million
  • In terms of data, I expect that by year-end, we should have some view of PK and safety. And that's really critical for us. I mean, I think we take a lot of comfort from the COMP360 Phase II study that clearly showed efficacy with psilocybin.
  • And we're also, and importantly, be leaving patients on their SSRIs. And we think this is an important point in that when we've seen 2 or 3 now small studies that indicate that leaving patients on their SSRIs may be either neutral to slightly positive.
  • So I certainly expect, probably in the sector, there to be more transactions over the next year.
  • I think that run rate looks like it's going to be around $10 million a quarter.
  • the bulk of the spend in the next 12 months will be around those CYB003 and CYB004 programs.
  • And our goal and our plan is to make EMBARK as a program, open source for therapists that want to get trained and want to learn more about psychedelic-assisted psychotherapy.

 

Psychedelic CEO Round Table hosted by The Psychedelic Investor on YouTube | feat. MindMed, Cybin and Field Trip (https://www.youtube.com/watch?v=TJ__XeXPKZA&t=1s)

  • MindMed: Rob Barrow, Cybin: Doug Drysdale, Field Trip: Ronan Levy
  • Field Trip
    • Adopted integrated model, focusing on innovating on the therapeuteic division. 2 divisions, Field Trip Health: developing clinical centers, ketamine currently, building revenue base, refferal base
    • Field Trip Discovery: Generating new molecules, FT104, a short acting molecule 2-3 hours, more clinically efficient, going to be a better medicine as well, consistent plasma profile
    • Interesting point about the role of the 5HT2 receptor, something that is not usually mentioned but will need to be addressed, cardiac issues. Sounds like focus on chronic administration (microdosing)
  • MindMed
    • Focusing on being a pharmaceutical company and becoming a powerhouse drug company
    • Broad pipeline; main focus LSD and 18MC, 2 clinical trials soon
    • 18MC: next generation psycedelic, chemical analog very closely related to ibogaine, designed and optimized to maintain effectiveness of ibogaine while reducing cardiac risk associated with ibogaine, no hallucinogenic activity as well. Developing for substance use disorders, in preclinical models: same potency as ibogaine and reduces substance abuse substantially (just finished phase 1 study)
  • Cybin
    • Engineer psychedelics into therapeutics, developing derivatives of psilocybin, DMT, and MDMA. Goal to overcome limitations and hurdles to approval
    • 4 sponsored clinical studies coming up this year
    • Focusing on reimbursement, so there can be maximized adoption
    • Biggest impact will be the durability, change from a chronic treatment to an intermittent treatment
    • CYB004 (DMT): goal to smooth out the curve because of some of the downsides that DMT has (opposite of others), creates less anxiety and more practical, just received patent for molecule
    • CYB003 (Psilocybin): Cuts time to 2-3 hours, faster onset action, removes interpatient variability as well
  • Next generation psychedelics
    • Will psychedelic therapy be dominated by completely new compounds or will the classic psychedelics still be vital in a therapy setting?
      • Huge unmet need in treating psychiatric and other brain disorders, not going to be a one size fits all
      • In shorter term, psilocybin and MDMA going to be first to clear, and going to create incredible impact
      • In longer term, likely to replace for 2 main reasons: time associated (just easier to develop clinics and get more patients treated with a shorter experience), going to address some of the limitations of the classic psychedelics