Update to Commsman's Pitcht for IMBARK PHASE III to the Geron Executive Management Team and Board of Directors
Posted: Tue Apr 16, 2019 10:31 am
On Tuesday, April 9 at approximately 1:30 pm Eastern Time, I received the below e-mail from investor relations:
“Hello Cxxxxxxx,
Thank you for your interest in Geron, your feedback is appreciated.
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.
-Jacob Goldberger, CG Capital”
OK Shorty’s, have a good laugh, I know I did! Longs and onlookers, you too! Enjoy a nice hearty laugh on me!
: - P
I actually first saw the email as I was registering for the Needham Healthcare Conference Call. I barely had time to read it. Basically, it was a nice polite brush-off! It also happened to kick off one of the busiest weeks of my year, so it just kinda’ simmered while I was distracted with the amazing Needham Presentation -n- Q & A session performance by John Scarlett, and then my personal fun busy week. Well, I got to thinking and jokingly mused to myself, …. “What would kmall do?” When it hit me, it was like a lightning bolt! The more important question for the moment was, “What would Commsman do?”.
: - P
I had just been given a very pleasant invitation to mail the Geron Board and Executive Management Team a letter! What a great idea! : - D So I printed my email and read it over…… Truthfully, I was a bit disappointed to find at least several typos and uncorrected auto-corrections in my email pitch. It dawned on me to appreciate that this DIDN’T make it to the board, because it wasn’t really ready.
I proceeded to edit, sand, polish, buff, and gloss my email into a nicely presented letter. Here is the text copy of my final print:
“Dear Geron Board and Executive Management Team,
I became a Geron Investor in March of 2018, and I made numerous investment purchases through July of 2018. I like to think many of my purchases went straight into the ATM Shelf Offering, and therefore, Geron’s general cash fund directly supporting the development of Imetelstat.
I would like to thank Dr. John Chip Scarlett and the Board of Directors for their professionalism and honesty in dealing with the investors. I have listened to each investor call and have found John Scarlett’s messages to be fair and prescient. I admit to being slightly impatient when Chip would talk so thoroughly about the plan IF JNJ/Janssen elected not to continue the collaboration as I thought JNJ would be foolish not to continue. However, I have been of the opinion since EHA in June of 2018 that Geron shareholders would gain far more value in Imetelstat if they got back 100% of the rights than they ultimately would from a continued collaboration with JNJ. When the discontinuation occurred, I remained confident that the science would ultimately prevail, and that Imetelstat is indeed a very promising treatment option for so many people with serious blood cancers. After the announced appointments of Dr Gutierrez and Dr Rizo, I nearly doubled my position in Geron with renewed confidence in Imetelstat’s future success. I’m even more confident now after listening to the excellent presentation at the 2019 Needham Healthcare Conference. Chip really knocked it out of the park by handling the JNJ/Janssen decision question gracefully and skillfully!
I am more or less a regular Joe with no official background in Hematology or Oncology, but I have researched nearly everything I can on the development and clinical history of Imetelstat. I understand that you are researching possible paths forward for developing Imetelstat to treat Myelofibrosis, and I would like to propose or offer support for an option for IMBARK Phase III. While I understand the strategic importance of creating a safe niche in the MDS indication, I think it would be a mistake to play an equally conservative card in the MF indication again. The strategy of “playing it safe” is already covered in IMERGE by treating highly transfusion dependent patients who are ESA relapsed/refractory and L & H naïve. This is a wise path towards proving the value of Imetelstat to MDS patients. However, I think it would be strategically advantageous to use a more aggressive strategy with MF. Considering that the only approved therapy (Ruxolitinib), has well proven to only be a palliative measure at best, and in certain subsets of patients has proven to bestow an increased risk, I would like to propose a phase 3 structure that could yield conclusive evidence as to whether Imetelstat should become an approved therapy option for MF as a Frontline Therapy Option.
IMBARK Phase III - Head to Head Ruxolitinib vs. Imetelstat
- Randomized Study of Treatment Naïve patients diagnosed with MF
Group 1 - Ruxolitinib only
Group 2 - Imetelstat only
Group 3 - Ruxolitinib + Imetelstat
One immediate benefit is that no patients would have the risk of getting no treatment in a placebo group. They would either get the standard treatment they would otherwise get without entering the trial, the experimental treatment that shows much promise in preventing disease progression, or both the standard and the experimental treatment. From all my research, it has become clear to me that many treatment options are needed by the doctors and patients. The next benefit is that this trial design would give Imetelstat 2 out of 3 paths to proving it is worthy of FDA approval as a Frontline MF treatment option, and Meatloaf always said, “2 out of 3 ain’t bad!” Considering the data that shows Imetelstat’s clear efficacy in ET and Dr. Tefferi’s pilot study that included earlier stage MF patients who were Jakafi naïve, I am very confident that Imetelstat will show a clear advantage over just Jakafi alone – especially if an endpoint goal is to remain progression free!
My intentions with this suggestion are meant only in the most respectful way. Please bring this idea to the experts and the FDA for consideration. I realize that the actual trial design has an enormous amount of complex factors that must be planned for, but I trust Dr. Rizo and team Geron to work out these crucial fine print details. I truly hope that this basic concept for the framework can prove helpful as I believe it would be a very direct path towards uncovering truth through good science. I would be remiss if I failed to reveal that my Grandmother is currently living with MF, so this is a topic that is personal to me. I kindly thank you for reading my letter and your consideration of these ideas. Please keep up the good fight!
Very Respectfully,
“Commsman”
Xxx xx xxx xxx
Xxxxxx, XX xxxxx-xxxx
xxx-xxx-xxxx
xxxxxxxxxxxx.xxx
Independent Investor
“Not everything that counts can be counted, and not everything that can be counted counts.”
- Albert Einstein “
Part 1
“Hello Cxxxxxxx,
Thank you for your interest in Geron, your feedback is appreciated.
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.
-Jacob Goldberger, CG Capital”
OK Shorty’s, have a good laugh, I know I did! Longs and onlookers, you too! Enjoy a nice hearty laugh on me!
: - P
I actually first saw the email as I was registering for the Needham Healthcare Conference Call. I barely had time to read it. Basically, it was a nice polite brush-off! It also happened to kick off one of the busiest weeks of my year, so it just kinda’ simmered while I was distracted with the amazing Needham Presentation -n- Q & A session performance by John Scarlett, and then my personal fun busy week. Well, I got to thinking and jokingly mused to myself, …. “What would kmall do?” When it hit me, it was like a lightning bolt! The more important question for the moment was, “What would Commsman do?”.
: - P
I had just been given a very pleasant invitation to mail the Geron Board and Executive Management Team a letter! What a great idea! : - D So I printed my email and read it over…… Truthfully, I was a bit disappointed to find at least several typos and uncorrected auto-corrections in my email pitch. It dawned on me to appreciate that this DIDN’T make it to the board, because it wasn’t really ready.
I proceeded to edit, sand, polish, buff, and gloss my email into a nicely presented letter. Here is the text copy of my final print:
“Dear Geron Board and Executive Management Team,
I became a Geron Investor in March of 2018, and I made numerous investment purchases through July of 2018. I like to think many of my purchases went straight into the ATM Shelf Offering, and therefore, Geron’s general cash fund directly supporting the development of Imetelstat.
I would like to thank Dr. John Chip Scarlett and the Board of Directors for their professionalism and honesty in dealing with the investors. I have listened to each investor call and have found John Scarlett’s messages to be fair and prescient. I admit to being slightly impatient when Chip would talk so thoroughly about the plan IF JNJ/Janssen elected not to continue the collaboration as I thought JNJ would be foolish not to continue. However, I have been of the opinion since EHA in June of 2018 that Geron shareholders would gain far more value in Imetelstat if they got back 100% of the rights than they ultimately would from a continued collaboration with JNJ. When the discontinuation occurred, I remained confident that the science would ultimately prevail, and that Imetelstat is indeed a very promising treatment option for so many people with serious blood cancers. After the announced appointments of Dr Gutierrez and Dr Rizo, I nearly doubled my position in Geron with renewed confidence in Imetelstat’s future success. I’m even more confident now after listening to the excellent presentation at the 2019 Needham Healthcare Conference. Chip really knocked it out of the park by handling the JNJ/Janssen decision question gracefully and skillfully!
I am more or less a regular Joe with no official background in Hematology or Oncology, but I have researched nearly everything I can on the development and clinical history of Imetelstat. I understand that you are researching possible paths forward for developing Imetelstat to treat Myelofibrosis, and I would like to propose or offer support for an option for IMBARK Phase III. While I understand the strategic importance of creating a safe niche in the MDS indication, I think it would be a mistake to play an equally conservative card in the MF indication again. The strategy of “playing it safe” is already covered in IMERGE by treating highly transfusion dependent patients who are ESA relapsed/refractory and L & H naïve. This is a wise path towards proving the value of Imetelstat to MDS patients. However, I think it would be strategically advantageous to use a more aggressive strategy with MF. Considering that the only approved therapy (Ruxolitinib), has well proven to only be a palliative measure at best, and in certain subsets of patients has proven to bestow an increased risk, I would like to propose a phase 3 structure that could yield conclusive evidence as to whether Imetelstat should become an approved therapy option for MF as a Frontline Therapy Option.
IMBARK Phase III - Head to Head Ruxolitinib vs. Imetelstat
- Randomized Study of Treatment Naïve patients diagnosed with MF
Group 1 - Ruxolitinib only
Group 2 - Imetelstat only
Group 3 - Ruxolitinib + Imetelstat
One immediate benefit is that no patients would have the risk of getting no treatment in a placebo group. They would either get the standard treatment they would otherwise get without entering the trial, the experimental treatment that shows much promise in preventing disease progression, or both the standard and the experimental treatment. From all my research, it has become clear to me that many treatment options are needed by the doctors and patients. The next benefit is that this trial design would give Imetelstat 2 out of 3 paths to proving it is worthy of FDA approval as a Frontline MF treatment option, and Meatloaf always said, “2 out of 3 ain’t bad!” Considering the data that shows Imetelstat’s clear efficacy in ET and Dr. Tefferi’s pilot study that included earlier stage MF patients who were Jakafi naïve, I am very confident that Imetelstat will show a clear advantage over just Jakafi alone – especially if an endpoint goal is to remain progression free!
My intentions with this suggestion are meant only in the most respectful way. Please bring this idea to the experts and the FDA for consideration. I realize that the actual trial design has an enormous amount of complex factors that must be planned for, but I trust Dr. Rizo and team Geron to work out these crucial fine print details. I truly hope that this basic concept for the framework can prove helpful as I believe it would be a very direct path towards uncovering truth through good science. I would be remiss if I failed to reveal that my Grandmother is currently living with MF, so this is a topic that is personal to me. I kindly thank you for reading my letter and your consideration of these ideas. Please keep up the good fight!
Very Respectfully,
“Commsman”
Xxx xx xxx xxx
Xxxxxx, XX xxxxx-xxxx
xxx-xxx-xxxx
xxxxxxxxxxxx.xxx
Independent Investor
“Not everything that counts can be counted, and not everything that can be counted counts.”
- Albert Einstein “
Part 1