Questions for the upcoming shareholders meeting
Posted: 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,
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,