Questions for the upcoming shareholders meeting

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biopearl123
Posts: 370
Joined: Fri Jul 20, 2018 5:13 pm

Questions for the upcoming shareholders meeting

Post by biopearl123 » Tue May 26, 2020 6:57 pm

With thanks to CKTC and HI and others for making the points that helped me frame this note:

Dear Dr. Scarlett, I write to you in your capacity as President, CEO and Chairman of the Board with the following questions submitted for your consideration at the yearly shareholders meeting, June 5th, 2020. I have been a shareholder for approximately twenty years.

When you assumed the helm at Geron you commented that the best time to sell a small biotech was when the company had accumulated good PII data. Since that now appears to have occurred, in conjunction with the approval of two PIII studies, do you still hold the same opinion?
Do you feel that enough data has been collected to make some comment as to whether the potential transformation to AML in both the MF and MDS study groups has been impacted by treatment with Imetelstat via disease modification?
Given the FDAs guidance regarding using RWD as an acceptable control and given their guidance regarding OS as the ultimate end point in conjunction with the establishment of on target surrogate indicators (h-TERT or telomere shortening) why were we not granted AA in the MF study? Can you make some specific comments about the TN group in the MF study?
Did the analysis of RWD from Lake Success and the lately added Italian study support the existing data of the control arm RWD OS determination?
What value creating events can we anticipate over the coming year? This is especially important since PIII data will not be forthcoming for years. It appears that the only clinical data we might expect in continued evidence for durability in the PII MDS study. Could continued durability data support AA status?
Can you elucidate information regarding the recent hires who were granted options?
Can you discuss what measures are in place to improve patient retention in the new studies and is it your sense that if patients knew that improved survival (an apparent surprise) was occurring in the MF study that physicians and patients might have been more inclined to stay on drug?
Are there any other drugs in the clinic that have shown disease modification and if so how does Imetelstat stack up against them? Where do you see the greatest competitive threats?
Can you discuss Geron's IP in other non Imetelstat oligonucleotides and monomers and also the status of the ongoing agreement with Janssen in the area on Geron's non Imetelstat IP?
A previous presentation has suggested Imetelstat synergy when used sequentially with JAK inhibitors. Can you update us on your thinking as to where this might go?
Have any patients in any Geron studies succumbed to COVID and if so how are they dealt with statistically?
Is the potential for a positive change in study status such as the granting of AA off the table or could it still happen (for example if the part I of the MDS study continued to show the remarkable durability it appears is emerging?)
Thank you for considering the above questions and please accept my congratulations on the truly remarkable progress you have made.

Sincerely,

cathy
Posts: 8
Joined: Thu Jun 04, 2020 8:14 pm

Re: Questions for the upcoming shareholders meeting

Post by cathy » Sun Jun 07, 2020 9:01 pm

Hello Andrew,
Could you discuss to what extent your questions were addressed and what new questions you now have as a result of the presentations?
Thanks.

biopearl123
Posts: 370
Joined: Fri Jul 20, 2018 5:13 pm

Re: Questions for the upcoming shareholders meeting

Post by biopearl123 » Sun Jun 07, 2020 11:38 pm

Hi sure, I will give you my take. My opinions only, alternative views greatly appreciated and encouraged.

When you assumed the helm at Geron you commented that the best time to sell a small biotech was when the company had accumulated good PII data. Since that now appears to have occurred, in conjunction with the approval of two PIII studies, do you still hold the same opinion?

Response: Not answered. We know that Dr Scarlett knows how to keep a secret, witness the secrecy before the Janssen agreement (nobody knew) and before the termination (nobody knew--no conspiracy theories please) so right now the stance is that they are going it alone with the new financing. The time line will take us into 2024 according to the recent call but I will address this in a separate post. Ryan thinks Dr. S will and should stay independent to the end (approval), I do not, favoring a partner or buyout. In any case the company is well financed and has no debt. But this question was not answered.

Do you feel that enough data has been collected to make some comment as to whether the potential transformation to AML in both the MF and MDS study groups has been impacted by treatment with Imetelstat via disease modification?

Respone: Dr. Rizzo says not enough data to say. My view is that they do know or at least have some preliminary ideas and ain't saying. One would think that given the known natural history of transformation in some patients, those who have received Imetelstat in both studies have been followed long enough to know how many have transformed to AML. Especially the high risk TN patients. I hope we will see cause of death data in the MF abstracts. I have some theories about this and will post them later.

Given the FDAs guidance regarding using RWD as an acceptable control and given their guidance regarding OS as the ultimate end point in conjunction with the establishment of on target surrogate indicators (h-TERT or telomere shortening) why were we not granted AA in the MF study? Can you make some specific comments about the TN group in the MF study?

Response: Not answered. Doubtful any criticism of FDA would be levied because of the power the FDA holds over the company (and all companies seeking approval.

Did the analysis of RWD from Lake Success and the lately added Italian study support the existing data of the control arm RWD OS determination?

Response: Not answered.

What value creating events can we anticipate over the coming year? This is especially important since PIII data will not be forthcoming for years. It appears that the only clinical data we might expect in continued evidence for durability in the PII MDS study. Could continued durability data support AA status?

Response: We should have no expectation that continued durability data would support AA in MDS. As to short term value creating events: (other than data release and EHA/KOL meeting): Not answered.

Can you elucidate information regarding the recent hires who were granted options?

Response: Only info on high level hires has been provided.

Can you discuss what measures are in place to improve patient retention in the new studies and is it your sense that if patients knew that improved survival (an apparent surprise) was occurring in the MF study that physicians and patients might have been more inclined to stay on drug?

Response: Not answered. One hopes this will be addressed in the KOL meeting and has been touched on by Dr. Mascarenhas last year.

Are there any other drugs in the clinic that have shown disease modification and if so how does Imetelstat stack up against them? Where do you see the greatest competitive threats?

Response: Dr. Rizzo: Constellation pharma has a drug that has shown fibrosis reversal but they do not know about any survival data unlike Imetelstat.

Can you discuss Geron's IP in other non Imetelstat oligonucleotides and monomers and also the status of the ongoing agreement with Janssen in the area on Geron's non Imetelstat IP?

Response: Not answered.

A previous presentation has suggested Imetelstat synergy when used sequentially with JAK inhibitors. Can you update us on your thinking as to where this might go?

Response: Not answered.
Have any patients in any Geron studies succumbed to COVID and if so how are they dealt with statistically?

Response:Not answered.

Is the potential for a positive change in study status such as the granting of AA off the table or could it still happen (for example if the part I of the MDS study continued to show the remarkable durability it appears is emerging?) Response: No expectation for such, see above.

cathy
Posts: 8
Joined: Thu Jun 04, 2020 8:14 pm

Re: Questions for the upcoming shareholders meeting

Post by cathy » Mon Jun 08, 2020 1:34 am

Thanks Andrew - so many good questions but so few answers! I printed out your responses and will use them to guide my study.
I am also starting at the beginning of Imetelchat and will work my way through all the posts. What a great education! Living with someone whose QOL might have been vastly improved by AA/compassionate use on a FIC drug brings home the tragedy of waiting years yet. All the best to you. Cathy

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