Questions for the Shareholders meeting

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biopearl123
Posts: 1665
Joined: Fri Jul 20, 2018 5:13 pm

Questions for the Shareholders meeting

Post by biopearl123 » Wed Apr 13, 2022 2:56 am

Well, It’s that time of year again (again and again), Imetelchat board members should be thinking of questions you wish to have the Geron board address. I will say in the past this one window into the Great Wall of Geron has been opened with what I have felt have been reasonable and honest efforts by management to address shareholder questions (but not necessarily “concerns” so much as we have all been “concerned” for decades now and the stock of course it at historic lows and dilution numbers. On the other hand we are approaching hard PIII data in several months and the yearned for inflection point may finally be upon us. To date, here are the questions I have come up with, please add to or modify.

1. To your knowledge are there any other agents in the clinic that specifically and selectively inhibit the malignant clone or malignant stem cell?

2. Once the PIII data is available for the MDS study, will control patients be allowed to cross over to treatment if the data supports a clinical benefit? As an extension, in the interim between TLR and anticipated approval, will the drug be (finally) available on a compassionate basis or will the time to approval (presumably the FDA will grant an accelerated path) be short enough to that this will not be necessary.

3. Can you please address the status of the QT sub study and discuss the expansion to other variants of MDS?

4. Do you anticipate that CAR-t or some variant thereof will eventually present a competitive therapy to Imetelstat?

5. Given the likelihood of the development of clonal drift and the inevitable “selection” of resistant clones, what strategies might be utilized in treatment programs in the future should aspect of disease evolution occur?

6. Given that some of Dr. Lane’s and Rusbolt’s mice may have been cured of disease and that Dr. Mascarenhas has hinted at a potential drug induced cure at some future time, it this a reasonable future hope for some patients or given what we know about the pathophysiology of the disease is it an impossibility.

7. If an oral version of Imetelstat or other telomerase inhibitor is successfully developed, do you think treatment of solid tumors might be revisited such that we would see broader use of this agent?

8. In older studies of gliomas in children, intracranial bleeding clearly limited the use of Imetelstat. Do you see any future strategies that might overcome some of the adverse affects seen in older studies?

huntingonthebluffs
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Joined: Wed Feb 24, 2016 12:00 am

Re: Questions for the Shareholders meeting

Post by huntingonthebluffs » Sat Apr 23, 2022 10:50 pm

Many great thankyou’s again biopearl123 for all you do on and for this board regarding our understanding and use in our personal medical and investing lives! I’m not sure there are many legitimate additional questions to be added to your list but I will submit a couple that you can add or not. Just wondering how Dr. John Scarlett would handle these or not might be of interest.

1. Assuming all the IMerge MDS Phase 3 results will be available to Geron in October 2022, is there any possibility that a preliminary TLR could be provided yet in 2022, even late breaking at ASH 2022 to go along with the reports on MD Anderson Lymphoid Malignancies Preclinical between Geron and MD Anderson and the Next Generation TI Program?

2. Given the preliminary readouts/ reports on IMerge Phase 3, Preclinical at MD Anderson and the Next Generation TI Program by yearend 2022, does that preclude any partnerships prior to that given the importance of one or more of those reports and the bargaining strength they would provide in any agreements with other pharma’s?

3. Are you resigning from other company's BODs because of personal reasons, imminent conflicts of interest or freeing up time to focus more on Geron as it establishes commercial capabilities in preparation for potential 2024 commercial launch or Imetelstat?

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

Re: Questions for the Shareholders meeting

Post by biopearl123 » Sun Apr 24, 2022 3:22 pm

Hunt, I will forward these excellent and relevant questions to Aron.

biopearl123
Posts: 1665
Joined: Fri Jul 20, 2018 5:13 pm

Re: Questions for the Shareholders meeting

Post by biopearl123 » Sun Apr 24, 2022 4:20 pm

Done.

biopearl123
Posts: 1665
Joined: Fri Jul 20, 2018 5:13 pm

Re: Questions for the Shareholders meeting

Post by biopearl123 » Sun May 01, 2022 7:02 pm

Good Morning Aron, I am submitting my last few questions for consideration by the board in anticipation of the May 10th shareholders meeting. I have always appreciated the consideration Drs. Scarlett and Rizo have given my queries in the past and hope the time allotted to shareholders concerns in the upcoming meeting will address the questions submitted to the fullest extent possible.

Additional questions:

1. Can you please clarify in the ongoing PIII MF study how patients who cross over into the treatment group will be analyzed. Since OS is a primary end point, once a control (BAT) patient crosses over to treatment , the utility of the control group (BAT) changes and the ability to assess treatment vs. control, as it affects OS also changes. So will crossover only be allowed after the “first look” or can it occur before, as apparently stated in the protocol, knowing that the end point of OS will likely be affected.

2. There appear to be only 11 US study sites anticipated for the MF PIII trial. This represents a very small fraction of world wide sites. Why is there not more US participation in this study particularly when large pools of potential patients exist throughout the US. In addition, the number of US sites is the same number as the Russian sites listed, not all sites in either locations are actively recruiting. Are world events affecting communication and cooperation with clinical sites in Russia that might affect ongoing enrollment and patient follow up?

Thank you to Dr. Scarlett, Dr. Rizo and the Geron Board for consideration of these and the previously submitted questions. Best wishes for a successful and informative board meeting. Your ongoing efforts on behalf of patients and your shareholders are greatly appreciated. Sincerely,

biopearl123
Posts: 1665
Joined: Fri Jul 20, 2018 5:13 pm

Re: Questions for the Shareholders meeting

Post by biopearl123 » Mon May 02, 2022 9:02 pm

As in the past, grades will be assigned depending on the quality and completeness of the answers to each of the question submitted.

kmall
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Re: Questions for the Shareholders meeting

Post by kmall » Mon May 09, 2022 2:48 pm

Great list of questions so far Andrew and Hunt......thanks for your on-going efforts in culling much needed information for both investors of Geron and those interested in the medical/scientific advancement potential of Imetelstat.

Hopefully it isn't to late to submit a last minute request.

My question would be UK ILAP Innovation Passport based.

With 5 full time Regulatory Specialists based in the UK, a satellite office in Altrincham, England and Tim Tickner - Director, Supply Chain Management, who was hired in January of this year, also based in the UK, what is Geron's timeframe and strategy with regards to filing UK MHRA approval?

A 10/25/2021 Press Release from the company confirmed ILAP Innovation Passport Acceptance of Imetelstat. Is Geron's recent footprint in the UK indicating a filing in the UK prior to an FDA NDA?

Thank you in advance for any clarification you can provide. -Kmall

biopearl123
Posts: 1665
Joined: Fri Jul 20, 2018 5:13 pm

Re: Questions for the Shareholders meeting

Post by biopearl123 » Mon May 09, 2022 4:43 pm

Kmall, have forwarded to Geron at your request.

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