Thank you @SADA, after a lot of reading couple of thoughts from me:
Basically, the vision of the company is to develop the next generation of opioids to treat severe pain while limiting the potential for abuse or overdose. Why is this a problem? Substance Abuse is the Nation’s #1 Health Problem and leads to 107,000 Overdose Deaths in 2021. At the same time severe pain is concomitant of a lot of diseases, such as Cancer.
Their leading research program is PF614 with the following goals:
Longer Pain Relief
True 12-hour Half-Life Ease of Swallowing
Can Dissolve in Water2 Can Be Taken with or without Food
Difficult to Manipulate Blocks Opioid Release if Inhaled/ Injected
Overdose Protection can be Added – Unique to Industry
To add the protection the company developed two core technology platforms
TAAP (trypsin activated abuse protection): designed to protect against prescription drug abuse
What do we know so far:
PF614 for severe pain combined with the ‘TAAP’ protection platform delivers potent pain relief equivalent to Oxycontin (Standard of Care) with reduced abuse potential
PF614 chemically releases oxycodone with the same extended release (ER) profile as OxyContin
The same release profile demonstrates that PF614 will achieve similar pain relief as OxyContin.
PF614, even when crushed, releases oxycodone slowly in the blood, thereby reducing the large Cmax which leads to reduced ‘drug liking’.
The study demonstrated the significant difference between the manipulated PF614 versus manipulated (crushed) OxyContin
As a result the FDA granted fast track for for severe pain + ‘TAAP’ oxycodone.
Regarding PF614 -MPAR TAAP (so protection by both platforms) pre-clinical data demonstrates that MPAR blocks Activation of PF614 and Oxycodone Release if Overdosed. I believe this is highly impressive. The only caveat is that its pre-clinical data.
The upcoming data catalyst is the read out of the Phase 1 PF614-104 Study. This study is designed to test and confirm that PF614 will have less potential for drug liking versus immediate release oxycodone at equivalent drug dosages. It does not include any protection platform (TAAP, MPAR).
The Goal of the Study is to Evaluate the Oral Abuse Potential of PF614 Compared with Oxycodone
If the data confirms what the company already promises we could see small jump, but for me the binary catalyst comes later in the year: PF614-MPAR-101 - (MPAR): Overdose Protection. This Trial is focused to proof the pre-clinical data under a clinical setting.
Position: Recommend a small position that you are willing to risk and hold throughout 2023 as the upcoming catalyst is not the binary catalyst and given the risk of delisting
The update is addressing the key questions in terms of pipline and outlook.
Most Important:
We have reported positive results on three of these studies, and we are currently awaiting data from our oral abuse potential study, PF614-104, at the end of March.
We see some green pre-market on this news but given the recent reverse split and the uncertainty regarding their financials i wouldn’t be surprised if we end up having a red day. I will exit the play during this week.
