Re: Letter to Dr. Scarlett
Posted: 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
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