CYBN
Cybin Inc.
stock NYSEAMERICAN

Open-minded to 004 not working in GAD, but that's not what the new leadership seems to have taken away from this study. Here is what was said on the call:
\-“We believe we have an emerging best-in-class profile with 004.”
\-“Imperative that you understand this was done on top of standard of care in moderate to severe GAD…these patients…it’s notoriously difficult to move the needle on them…and we have shown a significant signal in this population.”
\-“Importantly, in our phase 2 signal finding study in GAD, we saw correlations between EBI scores and HAM-A.”
\-“It was designed as a signal detection study. It was not powered to show separation between the two doses.”
\-“004 demonstrated a rapid and profound effect on top of standard of care.”
\-"When you get out to 6 and 12 and 24 weeks, you see a sustained reduction in HAM-A. This is not like placebo which generally after the treatment period begins to drift back to baseline."
The graph above is from a P1 study showing 2mg producing an EBI change in line with 20mg, and even higher changes for 25mg and 30mg. If EBI is in fact correlated with therapeutic change, it seems to leave the door open for even greater impact than that observed. Question as to why they'd pick 2 and 20 for P2 with this info.
If GAD is truly not viable, HELP will presumably put future resources into 004 in a different indication like MDD. That's not what the company is signaling, but we will see. It's not a one-indication drug.
All that said, it seems that CYBN should have designed this study differently. I'd think they should have obtained dosing knowledge from this study. Spending this much time and patent life just to get a "signal" seems questionable unless FDA wouldn't allow for it.
Also, the new CEO sounds very bored or tired and might benefit from public speaking training.

I actually can't fathom how CYBN only managed to run such tiny studies during the same time DFTX/MNMD recruited 200+ for a phase 2b
Mismanagement to the highest degree

I think it’s silly in the context of this being at best a minor play for them. For better or worse, CYBN is a one trick pony, and 003 is not the pony.

I think youre probably after CYBN which is trying to develop drugs based psilocybin

Open-minded to 004 not working in GAD, but that's not what the new leadership seems to have taken away from this study. Here is what was said on the call:
\-“We believe we have an emerging best-in-class profile with 004.”
\-“Imperative that you understand this was done on top of standard of care in moderate to severe GAD…these patients…it’s notoriously difficult to move the needle on them…and we have shown a significant signal in this population.”
\-“Importantly, in our phase 2 signal finding study in GAD, we saw correlations between EBI scores and HAM-A.”
\-“It was designed as a signal detection study. It was not powered to show separation between the two doses.”
\-“004 demonstrated a rapid and profound effect on top of standard of care.”
\-"When you get out to 6 and 12 and 24 weeks, you see a sustained reduction in HAM-A. This is not like placebo which generally after the treatment period begins to drift back to baseline."
The graph above is from a P1 study showing 2mg producing an EBI change in line with 20mg, and even higher changes for 25mg and 30mg. If EBI is in fact correlated with therapeutic change, it seems to leave the door open for even greater impact than that observed. Question as to why they'd pick 2 and 20 for P2 with this info.
If GAD is truly not viable, HELP will presumably put future resources into 004 in a different indication like MDD. That's not what the company is signaling, but we will see. It's not a one-indication drug.
All that said, it seems that CYBN should have designed this study differently. I'd think they should have obtained dosing knowledge from this study. Spending this much time and patent life just to get a "signal" seems questionable unless FDA wouldn't allow for it.
Also, the new CEO sounds very bored or tired and might benefit from public speaking training.

I actually can't fathom how CYBN only managed to run such tiny studies during the same time DFTX/MNMD recruited 200+ for a phase 2b
Mismanagement to the highest degree

I think it’s silly in the context of this being at best a minor play for them. For better or worse, CYBN is a one trick pony, and 003 is not the pony.

I think youre probably after CYBN which is trying to develop drugs based psilocybin