Ash posters

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biopearl123
Posts: 225
Joined: Fri Jul 20, 2018 5:13 pm

Ash posters

Post by biopearl123 » Wed Nov 06, 2019 4:12 pm


Ryan
Posts: 50
Joined: Sat Jul 08, 2017 1:41 pm

Re: Ash posters

Post by Ryan » Wed Nov 06, 2019 7:40 pm

What we found out this morning:
- Combo trials are in play
* Would love to see the AML combo re-emerge soon
- MDS updated data is coming
* Would love to see continued durability of Transfusion Independence. At what point is the TI 'tantamount to a cure'?;)
- Pre-clinical research and investigation is being done far a field
* Imetelstat clearly has a brand name in the heme scholar world at this point

Still lands with a thud on the stock market. When will the balloons fall from the ceiling? That's a great question, I must say.

biopearl123
Posts: 225
Joined: Fri Jul 20, 2018 5:13 pm

Re: Ash posters

Post by biopearl123 » Thu Nov 07, 2019 2:18 am

Ryan, thanks for your post. I see this a little differently. 1. There is no mention of AML probably because the program is probably dead in the water and Scarlett always skirts this issue (its oh so complicated, etc). 2. There are only two(or three counting the one Geron did not mention in the company PR) posters and not one of the more prestigious oral presentations. These poster presentations represent promising but early non clinical data and unless we see the clinical trials site on fire will not come to fruition for a long time. 3. There is an egregious absence of clinical data including updates of the PII MDS data re further durability data, and no mention of the current status of the MF patients (e.g. OS). 4. No paper (poster) has been submitted by the Dr. Rizo et al if I am not mistaken. 5. No RWD matched "control" vs. treatment data from Italy as we had hoped. I am perplexed and perhaps tomorrows conference call will provide some clarity but I am doubtful. I am open to revise these views with your help. bp

Zhears
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Re: Ash posters

Post by Zhears » Thu Nov 07, 2019 10:23 am

My hopes for ASH this year where none existent.
I had assume they would basically skip this year as they have been to busy hiring new staff, starting the P3 and basically rebuilding the company from scratch.

The meeting early next year with the FDA and RW data update at a conference is a possibility. However I wouldn't be at all surprised if they held back major release of information till next years ASH. Scarlet is going for the long term and doesn't care about short term share price.

Secret Third Arm
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Joined: Tue Aug 28, 2018 3:26 pm

Re: Ash posters

Post by Secret Third Arm » Thu Nov 07, 2019 11:52 am

Zhears,

The lack of concern by Scarlett about the short term share price is his Achille's Heel. At our current valuation it would not take billions of dollars for an interested party to get Imetelstat. It would only take a hostile attempt at grabbing control by a fund such as Baker Brothers to buy up enough stock at the current < $1.50. Maintaining a reasonable market capitalization is one of the many responsibilities of a CEO, and it is the Board of Directors job to hold the CEO accountable to this fact. With Scarlett as both CEO and Chairman of the Board there is no check on his power.

The lack of MF or MDS data is a huge red flag in my opinion. It would not have taken much to write a paper for ASH. The fact that the data is not being released and discussed by peers in the Heme Cancer space should concern us all. As stated repeatedly, one of the jobs of management is to be interacting with Key Opinion Leaders. These are the people at ASH and the same people who can demand that the FDA makes this drug available to patients.

Lastly, there is NO promise by Scarlett that even after the 1Q 2020 meeting with the FDA that we as shareholders will be informed about the contents of that meeting. I have carefully re-read his statements on this matter and they simply state that 'subsequently a decision about MF will be made'. What does that mean? Subsequently is an open ended timeframe, and a 'decision' does not necessarily imply that an announcement will also be made.

That means that there may be no catalysts for the stock until the 2022 data readout. That makes sense when you realize that management is diluting the stock at the ridiculous price of $1.46 a share. Basically they have telegraphed that any momentum in the share price above the resistance level of $1.52 will be met with shares being dumped on the market to counteract the burn rate.

Ryan
Posts: 50
Joined: Sat Jul 08, 2017 1:41 pm

Re: Ash posters

Post by Ryan » Thu Nov 07, 2019 6:56 pm

Patience is an easy concept but difficult in practice.

These trials are supremely trying he patience of all (hand raise), but it doesn’t change that the scientific progress has been nothing short of spectacular. I’ll add the key executive hires in the past year into that adjective spectacular. Those key experts are old news now, but where would we be without them.

Addressing several comments in this thread generally:
- AML is coming. It has already been stated that they are concentrating on the late stage clinical trials first. Resources and all. But to me the MF Combo study, which let’s face it came out of nowhere, is a nice leap towards the inevitable AML trial in the clinic. Still a long ways off but this progress is nothing to sneeze at either imo.

- MDS just wrapped up Phase II and entered Phase III. Nice! The poster was unexpected, as stated in the abstract is a new venue at ASH, trials in progress. Oral preso was already made in Europe in the summer, and thus wouldn’t qualify for an ASH oral preso. But this poster of trial design is great pub for Imetelstat and potentially updated data of durability of TI could Bev referenced in this poster.
- As I noted, longer durability of TI moves us into the realm of ‘tantamount To a cure’, one of my favorite phrases.

- searching the ASH data base for Imetelstat, there are numerous references outside of the ones Geron mentioned.

So I wouldn’t say swimmingly, but things are progressing. There’s no way imo that the trial doesn’t progress into 2020 and 2021 with ‘no news is good news’ and the value of the compound/company doesn’t finally start to progress in kind. My two cents.

nerdyboy99
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Joined: Wed Jul 25, 2018 6:33 pm

Re: Ash posters

Post by nerdyboy99 » Thu Nov 07, 2019 10:42 pm

Thank-you Ryan for your eloquent summation. Like many I have alot riding on this companies success and the years are taking a toll. Thank-you for reminding me of the sceince and the progress we've made in 1 year. Cheers all! Close your eyes and imagine that little kitten on a rope. "Hang in there!"
----
"You may say I'm a dreamer, but I'm not"
J. Lennon

biopearl123
Posts: 225
Joined: Fri Jul 20, 2018 5:13 pm

Re: Ash posters

Post by biopearl123 » Fri Nov 08, 2019 5:50 pm

J Lennon actually said, "you may say I'm a dreamer, but I'm not the only one." He would have plenty of company on this board. There was no reason I can think of not to update the durability data for TI to further shore up further respect for drug effect, unless there is not. Usually silence is not necessarily good, for example in AML which keeps resurfacing in discussion here. I think there is little if anything going on here and it has been years since Scarlett (or Lane) mentioned it seriously. The addition of statisticians and the late addition of the Italian site many months ago with no related ASH presentation is worrisome to me. This is my opinion only and I love the sunshine of others. Scarlett sounded bored or discouraged to me unlike his previous more upbeat recent presentations. This could be by design to dampen any irrational exuberance prior to the FDA meet. And as others have said, we wait. I wish you all the best and hope for some signs of approval for MF in 2020. bp

Ryan
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Joined: Sat Jul 08, 2017 1:41 pm

Re: Ash posters

Post by Ryan » Fri Nov 08, 2019 6:17 pm

In regards to the conference call, Dr. Rizo did most of the talking...

She explained everything going on pretty succinctly imo, and the bit of color regarding sequential dosing was of interest. As she stressed, there is a lot of critical thinking to be done for these combos, completely new terrain and complexity of multiple doses is near exponential as compared to mono.

There is no need to continue to reference AML - it was discussed by Dr. Rizo in the summer call. Many mountains to move before that, with a tiny team of experts.

When I’m on computer later, I’ll copy paste the seeking alpha transcript of call - I think people should think for themselves the value of this call and the progress.
Last edited by Ryan on Fri Nov 08, 2019 6:18 pm, edited 1 time in total.

biopearl123
Posts: 225
Joined: Fri Jul 20, 2018 5:13 pm

Re: Ash posters

Post by biopearl123 » Sat Nov 09, 2019 6:35 pm

Hi Ryan, thank you for your thoughts as usual. Yes it is clear the focus is on single agent use in the clinic now. Perhaps Geron felt it had enough to go to the FDA in Q1 with out providing additional RWD in the public domaine and didn't want to expend energy in this direction. Same for updating the data from part I of the MDS study. We have a lot riding on that FDA meeting. Re AML and combinations for MDS you can see how long it takes to get to a PIII study (have we ever gotten here before?-a great accomplishment in itself, one with great promise, especially since the odds of success are higher based on the dosing adjustment experience garnered from Part One of the PIII). So we won't see any action in the clinic for a long time unless the next MF study is a combo which would be very exciting. The wild card of course is an acquisition. Best Regards, bp

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