QUARTERLY IN DEPTH INVESTMENT ANALYSIS – BIOTECH UPDATE (NYSE: CYBN)
Disseminated on behalf of CYBN Inc (CYBN)
QUARTERLY IN DEPTH ANALYSIS UPDATE
This communication is not an offer to buy or sell securities nor is it to be construed as personal investment advice. Nothing contained in this communication should be relied upon as a promise or representation as to future performance.
CYBN Thesis Update
If you recall, we initially went out on this name back in June 2023 where it ran up 100%, took profits and then re-entered around $0.30 – right before Point 72 (Steve Cohen’s Fund) took a position and it ran up 200%. Shortly after, we took profits for a second time before we added back in at the 50 EMA, where we saw a nice bounce and another 75% run.
I have been watching $CYBN for quite some time and believe that I am starting to get a very good feel for the name, hence why I think the timing is right for another thesis update. Not only do I think that the chart is starting to look really good technically, there is a lot that is set to come down the pipeline and the recent sell off has led to some extremely attractive levels.
Similar to my previous thesis’ on $CYBN, below I will be breaking down where I see this name in the short to medium term as we get ready for this upcoming trading week.
Cybin Inc (NYSE: CYBN; NEO: CYBN.NE)
- Idea: Long $CYBN $0.34 – $0.40
- Target Area: $0.74 – $0.86+
- Stops: $0.20
- Time Frame: 2 – 6 Months
Pulling right back into the lower end range support here, extended as well which is why I think technically this is a perfect place to pick the name up. Idea would be to grab starter around $0.34 – $0.40 and add overweight into this name as that downtrend breaks. I would then be looking for a target around $0.74 to $0.86 in the medium to long term. Potentially getting into the $1.14 resistance if we go parabolic through those levels. IMO the risk reward on this name from this area is extremely attractive.
Upcoming Early 2024 Major Milestone Updates – CYB003 & CYB004
- CYB003 – Phase 2 Long Term (3-Month) Efficacy Data in Major Depressive Disorder (MDD) – Expected Q1 2024
- CYB003 – FDA end of Phase 2 Meeting – Expected Q1 2024
- CYB003 – Initiate Phase 3 Multisite, Multinational Trial in MDD – Early 2024 (recruiting expected to begin end Q1 2024)
- CYB004 – FDA Investigational New Drug Application (IND) for Phase 2 – Expected Q1 2024
- CYB004 – Initiate Phase 2 Trial in Generalized Anxiety Disorder (GAD) – Expected Q1 2024
Short – Medium Term:
Based on what I see in the near term pipeline I would expect short term speculation money (as well as institutional money) to flow back in at these cheap levels. Having Point 72 (Steve Cohen’s Fund) investing in $CYBN (September 2023) also gives me a higher level of confidence as his team (and fund) are some of the smartest on Wall Street – if they didn’t think there was something here they would not get involved. Nor would I expect them to sell any of their position unless there was a significant move in this name. I would assume that they would start adding into the name at these levels in order to bring down their average to a more favorable level. If we can get in front of that, we should have a nice amount of bullish liquidity to ride.
That said, I would be surprised if $CYBN did not receive their FDA Fast Track Designation for CYB004 in 2024 (they previously applied but were rejected because they did not have enough data at the time). Since their last application we have seen a favorable data release so I cannot see why they wouldn’t reapply for FDA Fast Track Designation, and get their approval shortly thereafter.
Recent Updates for CYBN’s Programs
CYB003 Phase 2 Topline Efficacy Data Summary:
- Rapid and large improvements in symptoms of depression observed after single doses of CYB003
- An average of 13.75 points on Montgomery–Asberg Depression Rating Scale (MADRS) which is statistically significant from placebo at 3 weeks (pooled 12mg and 16mg data – Stone et al, 2003)
- Clear incremental benefit of a second dose
- Incremental and sustained benefit seen as a further 5.8 points improvement on the MADRS total score with a second dose of CYB003 12mg at 16 weeks.
- Robust improvement in response and remission rates to >75% at 6 weeks after 2nd dose.
- Magnitude of improvement far superior compared to approved antidepressants and recently reported data with other psychedelics.
- These results compare favorably to pooled data from 232 industry studies of current standard of care antidepressants, selective serotonin reuptake inhibitors (“SSRIs”), submitted to U.S. Food and Drug Administration (“FDA”) which show an average improvement of 1.82 points on the MADRS total score vs. placebo.
- CYB003 has demonstrated an excellent safety profile – all reported AEs mild to moderate and self-limiting
- Data supports progression to Phase 3 study
- Expect 3-Month Long-Term efficacy data in Q1 2024
CYB004 Recent Updates:
- Intravenous (“IV”) CYB004 demonstrated robust and rapid-onset psychedelic effects at lower doses compared to native DMT, suggesting potential as a short-acting, scalable treatment.
- Intramuscular (“IM”) dosing of SPL028 produced robust, short-duration psychedelic effects in the majority of participants.
- Both IV and IM routes were safe and well-tolerated, with potential for IM administration to provide more convenient, patient-friendly dosing.
- Combined Phase 1 results for deuterated DMT program support progression to a Phase 2 study in Generalized Anxiety Disorder (“GAD”) in Q1 2024.
- Patent portfolio includes 40 granted patents and over 170 pending applications, with 25 granted patents directly related to the deuterated DMT program.
CYB004 Study Highlights:
- Escalating doses of DMT IV infusion over 90 minutes were well-tolerated.
- Robust psychedelic effects were produced, and the intensity of effects was related to the rate at which the peak concentration was achieved.
- Deuteration of DMT, as with CYB004, resulted in stronger psychedelic effects at lower plasma concentrations, compared with native DMT.
- These psychedelic effects were rapid in onset when administered as an IV bolus over 5 minutes and persisted for about 40 minutes after the bolus without the need for an extended infusion.
- This short duration of effects has the potential for CYB004 to be a scalable treatment that can be delivered in a shorter period of time compared with longer acting psychedelics.
CYB004 & SPL028 Phase 1 Summary:
- IV and IM routes both safe and well-tolerated.
- CYB004 and SPL028 demonstrated similar PK and PD profiles which allows bridging of data across molecules.
- PK profiles for both molecules demonstrated concentrations in the effective range.
- IM dosing of SPL028 produced robust psychedelic effects lasting a short duration in the majority of subjects.
Cybin Inc (NYSE: CYBN; NEO: CYBN.NE)
- Idea: Long $CYBN $0.34 – $0.40
- Target Area: $0.74 – $0.86+
- Stops: $0.20
- Time Frame: 2 – 6 Months
Current idea is speculation long on $CYBN (2-6 Months).
For the most recent Corporate Deck which covers some of the more recent study results in more detail you can find that here.
Spartan (aka ‘Chris’)
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