Hello Anna, with your permission, I would like to submit one more question for consideration that I hope Dr. Scarlett will address:
First off, thank you to John and Geron staff for your efforts on behalf of your shareholders and for the development of treatments to bring hope for as yet untreatable diseases. My question is this. There seemed to be an "evolution" of wording regarding how Janssen might approach the continuation agreement. Initially, it appeared that the decision would rely on the data from the R/R MF study. Only later was the parameter regarding the addition the MDS data added as to something Janssen would also wish consider. My question is: has Janssen ever expressed any doubts as to the strength of the MF data such that it would not allow enough information to continue the agreement on its own merits? As a corollary, while emerging MF data appears to support a longevity effect, does this imply an improvement in patient symptoms as well? One would assume the two should exist in parallel but we have heard nothing in regard to improvements in QOL parameters also, is it implied that this is also the case? Best wishes, for success.
Questions for shareholders meeting
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Re: Questions for shareholders meeting
Thanks BP. Where's Fish? Would like him to weigh in here if possible.
Re: Questions for shareholders meeting
Hip, Fish has been really busy and asked me to watch over his board for a little while, I miss his input also. Should be an interesting meeting. We are seeing a "loosening up" of Dr. Scarlett's vocabulary. "Independent Research Projects" (or something like that) is a new and an exciting one for me, especially if combination therapy progresses. Early candidates could be AML (probably not an "independent" study,) brain (see pediatric brain cancer consortium), pancreatic, see recent preclinical studies, MM, see small study that showed a reduction in MM stem cells but no clinical effect). More emphasis on disease modification, targeting of malignant clones, the new patent filing all seem to bode well. The April stop date for the study means that some predetermined number of deaths has been reached. It would be very interesting if this trigger was in the low dose or high dose group. I suspect it was in the high dose group since so few patients remained in the low dose group as to possibly not be statistically relevant. Even so I think there is a lot of clarification needed to understand exactly where we are. For example: At median follow up of 19 months, median OS had not been reached. But the study has been going on for way longer than that (max 32 months, minimum maybe 20 months depending when patients entered the study,) and many patients probably have been followed for more than 19 months as of January (and now for 22-23 months), and unless a lot of early enrollees died, its hard to know where we are. Of course we don't know how many patients remain in the trial and on therapy--(the holy nugget of information.)I don't really have a handle on when median follow up actually occurred in this context and whether a substantial lag in data analysis could make the actual survival longer once the final OS data is completely analyzed. Also there are likely "outliers", perhaps with a particular genetic signature that live much longer, hence the study protocol modification. I hope someone can pry some clarity out of John on Tuesday. Anyway I agree, would love to hear from Fish on some of this. Regards, bp
Re: Questions for shareholders meeting
Thanks for the response BP. There is so much written on Geron it's difficult to know what's been covered. And much information can be interpreted differently depending on your perspective.
From Q4 2017 Geron Earnings Conference Call, Olivia Bloom:
"For 2018 we are projecting an operating expense burn between $25 million to $30 million of which approximately $10 million to $12 million is expected to be for our proportionate share of cost to support the IMbark and IMerge trials under the Janssen collaboration. Approximately $8 million to $9 million for personnel related costs and approximately $7 million to $9 million for corporate cost such as business development, legal, accounting, IT and facilities.
This projection does not include any changes to the imetelstat development program or any acquisition costs associated with acquiring a new oncology asset, program or company and any subsequent development cost related to such an acquisition. Of course, if such potential changes were to occur, we would need to update our projections and depending on the timing and magnitude of those changes, we would need to seek additional capital. Maintaining sufficient financial resources enables us to promptly respond to such potential changes."
Removing the red herring phrase (for now) about acquiring a new oncology asset, we're left with
"This projection does not include any changes to the imetelstat development program. Of course, if such potential changes were to occur, we would need to update our projections and depending on the timing and magnitude of those changes, we would need to seek additional capital."
So one could conclude (perhaps):
1) Geron became aware of significant changes to the imetelstat development program in Q1 2018 thus requiring more working capital; The additional capital raise was not simply defensive.
2) Such a significant change would need to be disclosed for Q1 2018 reporting (May 15 CC,) which is one of the reasons I think Dr. Scarlett will disclose much more information tomorrow than many expect.
I remain long, and believe JNJ already made a decision, and Dr Scarlett has the answer. I'm appreciative of this site, yourself and Fish, as well as a few of the really bright minds who have taken the time to PM me over the years and explain/confirm many of the questions I had. In addition, my job involves working with and manipulating audio. I've listened to and analyzed many fireside chats and questions from analysts over the years, where sometimes Dr. Scarlett's answers veer away from the script; that's where the tells are for me. An example is his answer to Alex Schwartz during the recent Q4 2017 Earnings CC. He's really giving it away there… imo.
Best
From Q4 2017 Geron Earnings Conference Call, Olivia Bloom:
"For 2018 we are projecting an operating expense burn between $25 million to $30 million of which approximately $10 million to $12 million is expected to be for our proportionate share of cost to support the IMbark and IMerge trials under the Janssen collaboration. Approximately $8 million to $9 million for personnel related costs and approximately $7 million to $9 million for corporate cost such as business development, legal, accounting, IT and facilities.
This projection does not include any changes to the imetelstat development program or any acquisition costs associated with acquiring a new oncology asset, program or company and any subsequent development cost related to such an acquisition. Of course, if such potential changes were to occur, we would need to update our projections and depending on the timing and magnitude of those changes, we would need to seek additional capital. Maintaining sufficient financial resources enables us to promptly respond to such potential changes."
Removing the red herring phrase (for now) about acquiring a new oncology asset, we're left with
"This projection does not include any changes to the imetelstat development program. Of course, if such potential changes were to occur, we would need to update our projections and depending on the timing and magnitude of those changes, we would need to seek additional capital."
So one could conclude (perhaps):
1) Geron became aware of significant changes to the imetelstat development program in Q1 2018 thus requiring more working capital; The additional capital raise was not simply defensive.
2) Such a significant change would need to be disclosed for Q1 2018 reporting (May 15 CC,) which is one of the reasons I think Dr. Scarlett will disclose much more information tomorrow than many expect.
I remain long, and believe JNJ already made a decision, and Dr Scarlett has the answer. I'm appreciative of this site, yourself and Fish, as well as a few of the really bright minds who have taken the time to PM me over the years and explain/confirm many of the questions I had. In addition, my job involves working with and manipulating audio. I've listened to and analyzed many fireside chats and questions from analysts over the years, where sometimes Dr. Scarlett's answers veer away from the script; that's where the tells are for me. An example is his answer to Alex Schwartz during the recent Q4 2017 Earnings CC. He's really giving it away there… imo.
Best