Ren Benjamin, I salute you

[biopearl123]

I'll tell you why in a minute. First off I was locked out of the meeting, probably not intentional but it happened so I could not submit follow up questions in real time. That was a disappointment since there are issues of importance that still need to be addressed and were unanswered. I was gratified in a big way to see Dr. Scarlett finally make a statement as to the how undervalued Geron's shares are (see enterprise value post). I was also pleased to hear Dr. Rizo emphasize that targeting the malignant clone remains unique to Imetelstat. BUT. There is a change in wording and a reluctance to address the competition. To wit from the earlier 10 K: "We believe that the totality of these data provide strong evidence of disease-modifying activity of imetelstat treatment, which we believe has the potential to differentiate imetelstat from other currently approved and investigational treatments for MDS and MF". Compare that to the current wording that omits the words "investigational". Not a small issue since the competition is apparent. Now to Ren. Ren is the one analyst who really does his homework and asks valuable questions. Listen to the CNST call. He like us is trying to understand the effects on bone marrow of CPI-0610 (pelabrisib) and whether genotoxicity is an issue. My questions regarding Imetelstat and genotoxicity were completely unaddressed. (Review previous list of submitted questions.) Why I wonder. Ren held CNST's feet to the fire. I salute you for trying to elucidate the importance of this issue. Pelabrasib does have an effect on BM fibrosis. There was no differentiation discussion even though I asked for one. They hid behind the no clear (as yet ) data. This company is worth paying attention to since they to want to have recognition regarding "disease modification". I pitched Dr. Scarlett and team several slow pitches which they could have taken a swing at to differentiate Imetelstat. All we got is, it is differentiated "from currently approved treatments." What happened to "investigational"?? This is an important change in wording and Geron failed to address this question which was submitted in the forum they set up. As you know I was locked out and could not present any further questions. Please note that 35 minutes was allowed to answer questions in this once a year forum. Perhaps 20 minutes were used. I apologize to this board for my failure. The final chapter re genotoxicity has not been written. There was some dead space on the CNST call when this was brought up and they straight up acknowledged that testing had confirmed this and the consent process had been modified, but so far the FDA has allowed their studies to go forward. I, like Ren, seek clarification. Maybe Geron wanted to be Uber careful not to cast an unverified shadow on the competition or maybe they are outright afraid of it. I want to know which one it is. Regards to all, Awaiting the EHA abstracts with great interest. All things considered, things are looking good for 2023 commercialization and studies that are running ahead of the competition. And yes the stock is very undervalued. bp

[Ryan]

Noting that Constellation is in to Phase II - which may move faster than Imet MF Phase III which is specifically measuring OS.

My cliffs noted thought is, Imet should get approval, and combination studies will certainly follow in Imet’s Commercialization Phase. Imet + CNST/INCY (&/or) could be a cocktail that disease modifies while inhibiting symptoms. It’s complicated.

More simply, Imetelstat will receive approval in MDS before MF. And MDS is also bigger than MF, as you know. And the competitive drug on the market in MDS targets only a subset of what Imet is enrolling. All known points more direct to what we have heard the past couple days.

Still waiting on AML. Which obviously has a larger cohort population than R/R MF.

Full enrollment in MDS the next monster milestone, and like most if not all of the upcoming milestones to regulatory approval, is a question of when not if.

[Ryan]

Meant to write CNST/INCY *drug(s)

Bottom line,
These are mostly all moot points in re: competition v MF drugs, since Geron will be in a much different place as a company (if it’s still an independent company) by 2024/5.