Letter to Dr. Scarlett

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karagozoglu12345
Posts: 61
Joined: Wed Oct 03, 2018 12:48 am

Re: Letter to Dr. Scarlett

Post by karagozoglu12345 » Sat Jan 05, 2019 4:02 am

Received the below response today:


Dear Errol,



I realized that some additional context might be helpful regarding Geron’s policies and procedures related to corporate governance and investor relations as well as a proactive response to your questions.



As you may know, Geron has more than 60,000 stockholders. If we were to allow all stockholders to engage in two-way dialogue with our Board of Directors, it would very quickly become an unmanageable process, not to mention a potential disruptor to achieving our corporate goals. That is why it is the responsibility of Investor Relations to manage two-way communication between the Company and its stockholders, which includes sharing investor feedback with both management and the Board on a regular basis.



Role of the Board and Management (from Geron’s Corporate Governance Guidelines on our website)

The Board’s primary role is to oversee Company management and to assure that the long-term interests of the stockholders are being served. The Board is responsible for the oversight of the Company’s business conducted by its employees, managers and officers under the direction of the CEO. Both the Board and management recognize that stockholders’ long-term interests are advanced by responsibly addressing the concerns of other stakeholders essential to the Company’s success, including patients, physicians, clinicians, collaborators, scientists, employees, vendors, the communities in which Geron does business and the government.



As we have already agreed to share your list of questions with the Board, please take note of the Geron policy related to communications with the Board as stated on our website for future inquiries. Stockholders wishing to communicate with the Board, or with a specific Board member, may do so by writing to the Board, or to the individual Board member, and delivering the communication in person or mailing it to: Board of Directors, c/o Stephen N. Rosenfield, Corporate Secretary, Geron Corporation, 149 Commonwealth Drive, Suite 2070, Menlo Park, California 94025. All mail addressed in this manner will be delivered to the Chair or Chairs of the Board committees with responsibilities touching most closely on the matters addressed in the communication.



Please find answers to your questions below.



1) As you mentioned in your query, we have been informed by Janssen that the listing of imetelstat and CSF1R as investigational medicines available for pre-approval access was an administrative error. As a result, both drugs were removed from Janssen’s compassionate use pre-approval access website. Please refer to Janssen’s website for more information, https://www.janssen.com/compassionate-u ... val-access. With regard to Janssen's job posting, the job description outlined responsibilities for a variety of disease areas and potential products/line extensions that are consistent with what had been disclosed as part of the Janssen oncology hematology portfolio. Both events were Janssen corporate activities. We cannot speak further on Janssen’s behalf.



2) It is important to note that the FDA requires strict confidentiality regarding their discussions about any investigational new drug (IND) prior to its approval. We expect that it may be possible to design a randomized Phase 3 study of imetelstat vs best available therapy in relapsed and refractory MF, which is why we plan to discuss the results of the IMbark primary analysis with experts in MF (e.g., key opinion leaders or KOLs) and engage health authorities to help us establish clinical and regulatory expectations for the treatment of this patient population.



While the recent FDA guidance regarding endpoints in oncology is encouraging, it remains to be seen how theory will translate into implemented practice. We would expect to learn more as our discussions progress in 2019.



3) We estimated the amount of time it would take to transfer the IND from Janssen to Geron based upon our past experience of transferring the imetelstat development program and IND from Geron to Janssen previously. We believe our projections are both realistic and achievable. Transfer of the data and ownership of the imetelstat program is a complex process. There are more than 150 sites involved in the imetelstat clinical trials and the majority are still actively treating MF and MDS patients. The transfer of control of these sites must be undertaken with utmost care.



4) We had $184.8 million in cash and marketable securities as of 9/30/18, which we expect to be sufficient to initiate Geron’s next steps. We expect to fund the future development of imetelstat through Phase 3 in MDS and possibly MF. We also expect to initiate discussions with other possible strategic partners after the program has been fully transferred back to us, in particular seeking to identify companies who would be interested in ex-U.S. commercialization rights.



5) Janssen disclosed their reason for not continuing with the collaboration in a press release. We cannot speak further on Janssen’s behalf. However, as discussed during our Second Quarter 2018 conference call, we expect there were many factors Janssen likely took into account in making their decision about imetelstat, including data from both IMbark and the IMerge studies. Beyond the data from the MF and MDS studies, we expect there may have been other factors Janssen considered, such as: the number of, and end market potential for the indications they believe could likely be pursued with imetelstat; the time and cost of future development and commercialization; their assessment of whether the terms of the Collaboration Agreement remain beneficial for them; and factors not related imetelstat but highly relevant to Janssen's corporate portfolio strategy. These include the costs associated with other non-imetelstat development programs that are being pursued by Janssen and all of the various therapeutic areas in which they focus.



As we have already communicated and will continue to communicate over time, Geron is focused on and excited about moving imetelstat forward into further development in hematologic myeloid malignancies. Due to Geron’s extensive preparations for either potential scenario ahead of Janssen’s decision and to ensure that imetelstat would continue to move forward regardless of Janssen’s decision: we strengthened our balance sheet to support future development plans and had $184.8 million in cash and marketable securities as of 9/30/18; we have and continue implementing necessary operational plans to take full responsibility for imetelstat; and we have engaged a global CRO to ensure that we are able to move the clinical development of imetelstat forward seamlessly.



Our responsibility, first and foremost, is to ensure that our first-in-class telomerase inhibitor, imetelstat, successfully navigates its way through the regulatory process and is able to one day reach the patients who currently have limited treatment options available today.



We are excited to move imetelstat forward, and expect to generate shareholder value over the long-term as a result.



6) In order to support our goal of moving the imetelstat development program forward, Geron has engaged the services of a global CRO who has the resources and expertise to assume responsibilities for conducting our two active global trials, as well as conducting future imetelstat clinical trials and is also actively involved in the transition of the imetelstat development program back to Geron. We have also engaged additional subject matter experts in clinical science, biostatistics, clinical operations, pharmacovigilance, quality systems, manufacturing and regulatory affairs. In addition, we have started the process of hiring a number of senior personnel to re-staff our internal drug development group. You may have noticed the key postings on the new Careers section of our website.



-Jacob Goldberger, CG Capital

huntingonthebluffs
Posts: 246
Joined: Wed Feb 24, 2016 12:00 am

Re: Letter to Dr. Scarlett

Post by huntingonthebluffs » Tue Jan 08, 2019 9:43 pm

First, I certainly believe that JS/Geron/IR are underestimating, probably intentionally, the percentage of the 60K investors in the stock that have those very same questions. SA alone has over 30K following Geron related articles/newsreleases/conference calls/comments etc. so while not all will agree with the questions there is a extremely large following vested in these iterations on your emails to Geron. In addition, the various stakeholders mentioned in Jacob’s response (Q. #1)also have those same questions. To lump your questions in as one or as a few of 60K investors does not reflect our scope of ownership or show appreciation for the level of input and effort to raise these important questions. I might also suggest that you request further respectful input from membership on a possible response back to IR from the various ImetelChat, YMB, SA, Twitter, etc.

Secondly, respect can grow with your continued contributions along these lines. You have possibly become a defacto representative for many, not just the retail investors. And in that vein, you might consider continuing a relationship with Geron as the voice that gathers and brings the critical / tough questions (current and future) forward in a responsible and respectful manner for many of us as we go down the path towards various approvals. While you haven't asked for such a role, you have done an excellent job of pulling a large collection of inputs and thoughts together so if you are so inclined, I for one would be very grateful.

I did feel that there was some new information and some additional room provided for positive interpretation given a noticeably more aggressive tone.

Unfortunately, on #1 their responses as to “what happened” may be “largely” the reality from Geron’s view point. It is possible that Geron has the same questions / doubts about JNJ/Janssen’s actions during 3Q2018 while unsuccessfully requesting explanations from JNJ/Janssen. It is plausible that the activities covered by the “smoke screen” were mostly, maybe entirely outside the JSC. Without inside information and they may not have it, how does one assess blame or cause or explain to anyone’s satisfaction? We are probably beating on a dead horse on this question.

On #2, they will be having discussions with the FDA. It will likely be very intense discussions and the FDA will be pushed hard to abide by their new guidelines as many lives are at stake. Geron has a strong hand here and they know it, let’s see if they can be effective in the trenches. I expect that they can and will.

With my selective hearing and reading between the lines, in the short term, i.e. the next 6 months I can envision a significant number of moving parts that could change CT plans and acceleration could occur on several fronts. That’s what I am hearing in the response between the lines on #3, maybe I’m imagining but I think we all believe the plans will change.

On #4, I think they believe they have a strong hand and will not have to license a partner in the US but will ex-US. The cash on hand takes them a long way in to the future. With a fair treatment by the FDA and two shots on goal, the share price will be much higher if further dilution is needed to reach the end zone. I think they are confident on this and will not show their hand just yet and shouldn’t until after the dust has settled on their discussions with the FDA as that could have major implications that significantly strengthens their hand regarding any future partnership negotiations.

On #5, sounds like an enthusiastic and passionate response to me. What is not to like about contracting with a global CRO for the two CT’s in progress and future trials as well. The transfer from Janssen is going into both Geron and the CRO fabric so that seems reasonably efficient to me. And once all is on Geron’s turf, I think you will see Geron stepping up the pace far in excess of the JNJ/Janssen efforts, regardless of whether or not there was devious and/or intentional mismanagement.

On #6, Geron seems to be ramping up fairly rapidly but I am not one to assess if this could be done faster or better, but they are not standing still. Are they using the various sources of subject matter experts as well as they should? Again, I’m not one to assess but taken at face value, seems they are doing things in an intelligent way, while never fast enough for some.

In regards to all the second guessing of what JS / Geron are doing, I have two thoughts. One, don’t mistake action for progress as we likely only see the tip of the iceberg and secondly don’t mistake all gray hair for old, tired and ineffective. Like it or not, we are going to need to give Geron a year before we can fully appraise their efforts and results. I personally think many of us will be reasonably satisfied.

bucbeard
Posts: 80
Joined: Wed Jul 25, 2018 12:30 am

Re: Letter to Dr. Scarlett

Post by bucbeard » Wed Jan 09, 2019 2:15 am

I really appreciate the thorough, rational and well thought-out responses Hunting. You are a reasonable and calming voice in the uncertain environment that surrounds Geron shareholders.

As I've mentioned on SA, there are a few handfuls of posters that bring great value to our community. Thank you for sharing your gifts and wisdom. We are all better off contemplating your strong contributions.

Some very bad things have happened to all of us on this journey, but there is plenty of positive things that fuel the fire of our hope. For that too, I am thankful.

Let us continue to monitor and press our leadership where they fail us, and support them where they show promise.

Onward Geron friends.

huntingonthebluffs
Posts: 246
Joined: Wed Feb 24, 2016 12:00 am

Re: Letter to Dr. Scarlett

Post by huntingonthebluffs » Sun Jan 13, 2019 8:35 pm

Thanks Bucbeard for the kind words and your thoughtful comments as well. Yes, in this endeavor especially, we can all find value in applying the best version of ourselves to advance this cause.

I, along with many, including yourself, biopearl and karagozoglu12345, have shared their concerns regarding the party line about events during the waning days and hours prior to the negative CD. Having endured that, we all have varying degrees of distrust regarding what happened, who knew what and when, what discussions actually occurred between the members of the JSC and JNJ / Janssen senior executives, what did JS know “unofficially” from his contacts outside the JSC, why investors were seemingly allowed to be indiscriminately misled, etc. Trust is important here and much has been lost in that regard.

However, we as investors, patients, stakeholders in general must now ask the question where we best put our focus at this point given how the David and Goliath analogy resonates here. Even knowing much has avoided accountability, likely due in part to the daunting task of addressing it or encountering unforeseen and undesirable repercussions. Justifying an inquisition becomes a weighty challenge in the context of time, effort, cost and maintaining JNJ/Janssen cooperation which is without question needed throughout the transfer and probably in connection with the FDA/EUA discussions and even beyond. If I am an investor or especially a patient where time is of the essence, I might ask how important is seeking retribution compared to pushing the science through the steps needed for approval. Maybe there is some redeeming value in picking up and wielding the hatchet now, but that wouldn’t be my choice as long as “they” appear to be getting it right this time around.

Even with the recent set backs and delays, many of us think we are close to major progress being made and reading biopearl’s New Year’s Wishes and predictions, one might expect many exciting events and developments in 2019 alone. For now at least, I think we need to press the reset button and stay focused on the results. For our part, hopefully we can continue to seek answers in an effort to ground our expectations and investments as we proceed along. Reading all 8 of Sdraws recent tweets is a good place to start. I personally prefer to focus on these activities and hopefully we can in some small way collectively contribute to Imetelstat’s approval and to the patients in need. This would be versus applying our energy to uncover the backroom secrets covering up the misdeeds and / or mistakes of JNJ/Janssen and Geron management / BODs. They will not be excused, just not likely uncovered anytime soon if ever.

On a side note, I have participated in an email dialog with karagozoglu12345 and biopearl In regards to the ImetelChat members becoming a defacto activist, in what appears to be a void for several stakeholder groups. ImetelChat members could play a role in collectively refining respectful / responsible / important ideas / questions / recommendations that could be then forwarded to the Geron IR and executive management / BOD for their consideration and feedback at various appropriate times. Also we might have input that we would want provided to the FDA/EUA and even the media such as Reuters etc. While we could be disappointed in our results and impacts, we might find our efforts multiplied beyond what anyone has considered possible to this point.

As a starting point or not, someone could start a new thread to discuss and share any additional ideas to karagozoglu12345’s approach with the JS and BOD Letter. While we currently seem to be at a point where we just need to wait for the next expected events / activities to occur / begin, eventually another thread could be initiated with timely questions, recommendations, actions that we collectively want to refine and advance.

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