What did JS et al at Geron, learn about the science during the Janssen saga?

Forum rules
- Comments must be civil and on topic
- Back up claims with evidence/reasoning/sources (posting links is allowed)
- No commercials/harassment/spam
Post Reply
huntingonthebluffs
Posts: 138
Joined: Wed Feb 24, 2016 12:00 am

What did JS et al at Geron, learn about the science during the Janssen saga?

Post by huntingonthebluffs » Tue Oct 30, 2018 4:52 am

I have been contemplating what JS et al at Geron have learned about the TI science covered by the Geron patents and the realities of the challenges in actually getting it to market. One might assume that dozens of studies using Imetelstat have been carried out over the last 4 years along with the CTs and pre-CTs at Janssen. JS has undoubtedly discussed various at length with people involved with these activities, certainly with Tefferi, Raza, Lane, etc. Also with various contacts at several pharma’s covering science, potentials and M&As.

JS is upbeat and positive about Imetelstat’s future, so of course the short ensemble on YMB and the SAB again deceptively state it must be so he can keep getting the salary since they somehow know the stock is going to 0 and the options are worthless. After all a man 67 years old is too tired to accomplish much at his advanced age but while independently wealthy he clearly wants to plod along collecting his 1MM annual salary. I can’t find any way to swallow this hook, line and sinker or even consider it for a second.

And now several of the boards great technical and scientific minds are throwing up their hands saying the science is to dated and will soon be run over by competition brandishing newer science. While for me this is truly a little disconcerting, however in my brain, both left and right sides and my heart tells me they aren’t thinking too clearly due to the financial beating they took on September 27. Well, I do understand that as I was there too, but just too contrarian to buy into that phycology.

So I guess to buy into the boards vomit, we have to value the patent farm at $0, JS and his board as all dummies, all the studies finding significant disease fighting results, the TI science becoming to old and challenging to bring to market, etc. etc. Again, I don’t think so, not for a second.

Let’s turn all the potential over to Jakafi, Lenolidamide, Darzalex, Luspatercept since they are doing such a great job with OS, QOL, actually dealing with the cancers at causal level, so MF, MDS and AML patients are benefiting beyond anything Imetelstat could ever offer. Really??? Good luck with that strategy, or even assuming it is just a matter of time before the competition overtakes Imetelstat. None of the above drugs or any others for that matter have shown the results provided by Imetelstat when the playing field was level and in some cases we are talking an order of magnitude or more.

So if anything I have given JS credit for in the past (risk taker, decision maker, intelligent, honest, disciplined and savvy business man, believer in Imetelstat’s science, etc.) was fair and mostly correct, then I’m relatively certain the Geron assets are still in good hands and incredibly valuable. I for one, think the JS and the Geron BOD know where they are heading and have the full intention of getting this science over the goal line and sooner than later. And I think for those wanting a BO, it could come faster in the “after JNJ/Janssen era”. For those wanting commercialization, it could easily come as fast or faster assuming it was ever JNJ/Janssen’s intention to commercialize. Combinations can clearly come faster as JNJ/Janssen seemed to strangely put on the brakes when they discovered how astounding the Venetoclax / Imetelstat combo appeared to work on AML. So for me at least, I’m not budging from my investment position. I think ASH and post ASH CC’s will begin to paint the new path forward to be more exciting and speedy than the mediocre efforts put forth by the previous partner in the CLA. Of course it is just my opinion but I do think I’m finally thinking clearly again after the JNJ/Janssen debacle.

huntingonthebluffs
Posts: 138
Joined: Wed Feb 24, 2016 12:00 am

Re: What did JS et al at Geron, learn about the science during the Janssen saga?

Post by huntingonthebluffs » Tue Oct 30, 2018 11:04 pm

So what did they learn? Anybody? What conclusions have they reached? I wouldn’t even attempt to summarize all the technical and scientific details / milestones even if it was within my pay grade. There were many for sure but much of it was not made public in a way to formulate conclusions. Enduring such silence was painful, yet many on the various boards were articulate about the various posters and presentations that occurred at hematology conferences. Along with other pre-clinical and the various scientific papers, much has been learned and accomplished and clearly listed out.

Yet we are still waiting for something substantial regarding the CT results and next steps. Obviously one just needs to look at the stock price to realize we are missing the last pieces of the puzzle. So what did they really learn, they need to net it out for everyone as soon as possible, which for me is by the end of the year 2018. I think they will. I also think they will need the next two months to get that accomplished but starting with a new information sharing MO on November 1 would be a great place to begin.

JS has said that Imetelstat has been de-risked in both active trials and in my mind that is very important, key actually. Yet seeing the current results from the additional 25 added to the IMerge study and normalizing the findings based on the transfusion burdens of each patient seemingly would provide much of the link to effectiveness that is missing between the original and additional patients. In the MOS component of IMbark, we need to know the status of the MOS metric and the current or final number of months. And for both CTs, what are the PRs, CRs, Cis, His, etc. etc.? So realistically JS et al are way past the de-risked stage of knowledge, they now know all or the majority of the metrics for both CTs as does the FDA and probably EUA. They also know what the next steps are to get Imetelstat through the NDA and to commercial status both from the FDA/EUA perspective and businesswise. This for me personally, sums up where we are and what JS et al know as a result of the Janssen saga, so no matter how much distaste I have for JNJ/Janssen, the Imetelstat drug is well on its way to commercialization and patients and our investments should be doing fine in the near future as well.

Now as a last thought about what the insiders know, I personally would like to know what the conclusions would be for IMbark CT if the study could be reviewed in hindsight using primary and secondary endpoints that made sense. That is from a patient perspective versus what was “decided” based on what was previously used in a patient population of comparatively healthy patients, “recently” diagnosed with MF, versus R/R patients being treated years since their diagnosis. Can the new FDA and EUA be so blind and stupid and then just swallow and move on? I hope not as this is not a dress rehearsal for these patients.

Greg E
Posts: 7
Joined: Wed Jan 13, 2016 11:47 pm

Re: What did JS et al at Geron, learn about the science during the Janssen saga?

Post by Greg E » Wed Oct 31, 2018 10:09 pm

Thanks for the thoughtful summary. We will learn more about efficacy as the results of IMbark and IMerge become better known beginning with the release of abstracts tomorrow and through ASH, and the efficacy we already know of from the earlier trials, especially the Mayo Pilot, still speaks loudly to me.

Forgive the following understatement as I want to say this in the least controversial manner:

IMbark was poorly designed from the start. That even with this design imetelstat may show a clear MOS advantage is significant.

IMerge was poorly executed as far as the additional 25 patients go. If the 38 naive patients in the trial continue to show a large reduction in Transfusion Burden this means imetelstat can help patients. Reduction in transfusion burden is coincident with better outcomes. If infusing imetelsat results in a large reduction in blood transfusions it should be available to patients given its safety profile.

The last point you made touched me the strongest. I have been acutely aware of it since the stunning Mayo results came out. This is not a dress rehearsal for those with MF and MDS. You used the word debacle in relation to the CLA,- there is no group of people for whom this is more true than for the patients who could be benefiting from imetelstat had the trials been designed to capitalize on the previous success of the Mayo results. If there is one thing JS and management need to learn that I am doubtful they can learn it is that they are capable of screwing this up- because they have already done so. If they can acknowledge to themselves at least that they made mistakes, then I think their chances of success from this point on are much better.

bucbeard
Posts: 24
Joined: Wed Jul 25, 2018 12:30 am

Re: What did JS et al at Geron, learn about the science during the Janssen saga?

Post by bucbeard » Sat Dec 15, 2018 4:23 pm

Hunting, Greg (and others) - in light of the previous thoughts expressed on this insightful thread (which are very strong and to which I agree), how do you feel about the state of affairs post ASH/Investor conference? Obviously the positive trial data has been further confirmed, but are there any new positive revelations or concerns from what you have heard that are significant, as it relates to your previous comments from end of Oct?

Gwikley
Posts: 31
Joined: Thu Aug 30, 2018 9:05 pm

Re: What did JS et al at Geron, learn about the science during the Janssen saga?

Post by Gwikley » Sat Dec 15, 2018 10:51 pm

Constantly amazed at the plodding, hesitant and (still) cumbersome process(es) used by the FDA.
Granted, protection is their mission. And appreciated. However, from a patients view point, if a
drug candidate has controllable toxicity, and statistically gives just ONE MORE DAY to live, where is the justification
for denial?

huntingonthebluffs
Posts: 138
Joined: Wed Feb 24, 2016 12:00 am

Re: What did JS et al at Geron, learn about the science during the Janssen saga?

Post by huntingonthebluffs » Mon Dec 17, 2018 7:30 am

bucbeard, I have a lot of thoughts but I cannot find a real anchor point as to hinge an opinion on other than the science continues to shine brightly. Being retired, I do have time to stare at the ceiling and contemplate my navel so take this for what little it is worth.

I wonder about a lot of things that went down with the JNJ/Janssen CAD. Much of that we can only speculate about and I am not in the know so most of my previous thoughts about it stand. Additionally, there is enough smoke here to say that Janssen and JNJ were not in agreement on what exactly to do. JNJ/Janssen still has the “other” license agreement in place and may be still working on their “business strategy” around Geron’s patent farm. However, from this day forward “trust” will always be an issue with them.

I do have to wonder about the timeframes we are being given to transfer the IP back to Geron, delays to get the MDS phase III study going and through completion, effort to pull together a quorum on how to proceed with the MF trials, etc. However, I would say this about the grinding and nashing on the boards with regards to time and effort now being cited by JS/Geron, Janssen spent 4 years on two trials and supposedly they were in a hurry to reach FDA /EUA approvals, and did we get a good result out of that so called fast planning effort. I would think not. Were they really in a hurry? Possibly as there are several sides of the argument.

However assuming JNJ/Janssen were in the picture prior to the hold in 2014, it still took them a year to get a signed agreement, almost another year to get to the first patient dose in MF and even longer to get to the first patient dose in MDS in early 2016 and then almost another 3 years to reach a conclusion and make a decision on the continuation. So barring some form of acceleration by the FDA, the timelines are at least as good as the JNJ/Janssen stars and probably better. And I would have to think that some reengineering many of us think is obvious, is taking place regarding the design of the PIII CT(s). Which seems appropriate based on the current state of knowledge and experience coming out of the PII’s and would also take some extra time not likely in the “original” CT plans.

So for me, I’m not going to get on the bandwagon that says Geron is demonstrating poor business judgement and under achieving on all points ahead with the CTs. Anyone who can only read the CCs and analyst meetings as locked in stone may have another agenda or just not willing to face reality when clearly new FDA designations or acceleration would have major implications to the timelines. New agreements with other BPs would clearly affect the number of CTs and progress on combinations. Why do we know that? Because JS is conservative at best on communicating any optimism and would never over promise. When would all these considerations change? Well don’t we all know the ramp is over the next 6-12 months, after the IP has been transferred back, the MDS CT moves to PIII and the tethers are finally cut with JNJ/Janssen. Another year of fog, I don’t like it either.

Geron by itself, certainly cannot give itself new designations or acceleration, they can only request and that seems quite likely based on what we know of the FDA policies/requirements and the PII CT results. Getting the FDA/EUA to open their eyes and come to the aid of thousands of patients losing hope here appears to be like pushing a wet noodle. Maybe we should be launching our rage at the government agencies versus trying to bully Geron . Maybe we should ask JNJ/Janssen to be accountable for what they have done / decided, just in case you are fond of pushing a wet noodle.

So for me, I’m impatient, I want to see progress across the landscape. With no entity willing to talk about what is going on here makes this almost impossible to discern. Is it possible that there are good reasons no one is talking? Seems likely to me. I personally will stay the course, whether or not I live to see the day doesn’t really matter as I think the promise of this science will prevail and looks more promising with each new day.

huntingonthebluffs
Posts: 138
Joined: Wed Feb 24, 2016 12:00 am

Re: What did JS et al at Geron, learn about the science during the Janssen saga?

Post by huntingonthebluffs » Mon Dec 17, 2018 7:18 pm

So continuing on, now that we know the science is in better shape than ever, the focus of the boards seems to be to go after and replace the CEO and BOD, not likely but we can think about it. Will that help? How exactly will that speed up commercialization of Imetelstat? Can the new supposedly younger and energetic faces give themselves new drug designations or acceleration? How about a successful NDA? Don’t think so.

So what exactly will that do for the patients waiting or the investors? Would it put us on a better, faster track to our goals? Maybe, maybe not. Many seem to be making their assertion / guess about what should and would happen based on what they see in the proverbial “tip of the iceberg”.

However, there is a mountain of data and information missing from our thought processes and certainly several key pieces. I personally don’t feel confident about what is needed in this recipe based on our ability to gather data, analyze it, reach conclusions and make decisions. So maybe some are just “stating their recommendations based on their experience and knowledge from their story”. Or maybe it is based on the current GERN share price, or maybe their gut, etc.

For me, my knowledge and experience says that “usually” change largely for the sake of a new style is just busy-work and that doesn’t always lead to progress, might even be the opposite. Certainly changes can be good and probably some seems obvious here, such as answering more questions and sharing the recent CAD, etc. Could replacing the A team at this juncture help? Is it just because we think they are out of touch with investors or they are truly not acting in good faith with company assets? Anyone got a crystal ball here that works?

Based on what we’ve been told, It seems apparent that we need to endure at least another 6-12 months for the “real" Geron plan to unfold for us. But just maybe, JS/Geron has a better story in mind for us given the results presented at ASH and the analyst/investor conference. Seems likely to me.

bucbeard
Posts: 24
Joined: Wed Jul 25, 2018 12:30 am

Re: What did JS et al at Geron, learn about the science during the Janssen saga?

Post by bucbeard » Tue Dec 18, 2018 12:14 pm

thank you Hunting. your insight is extremely valuable and personally useful for me attempting to make some sense of this crazy puzzle through piecing together all the various moving parts, even when it often feels like a pointless exercise. I find myself in complete agreement with your sentiments and thoughts.

our patience and faith will indeed be tested. i am settling in for a long, cold winter for this GERN share price but i believe that the highest quality seeds of this science will sprout meaningful growth in the spring. i also believe there will be fruit in 2019, but it is up to the talents of our old farmer to manage the FDA climate and partnership/acquisition fertilizer to determine the size, color and taste of it.

i think it is healthy for the farm hands to put a little pressure on our current farmer, so that he understands that there is still accountability (stay off the share options moonshine!) and that he ultimately needs the cooperation of the farm hands to bring the fruit to the market consumers.
that said, bringing in another farmer would likely cause further delay, as s/he must learn the lay of their new land.

hope springs eternal...i pray we don't lose the farm in the process.

huntingonthebluffs
Posts: 138
Joined: Wed Feb 24, 2016 12:00 am

Re: What did JS et al at Geron, learn about the science during the Janssen saga?

Post by huntingonthebluffs » Tue Dec 18, 2018 9:23 pm

bucbeard, I enjoyed your analogy and agreed with your thoughts and focus on sending and expecting a significant level of moderation on options, raises and bonuses for 2019.

I liked the following post from the latest SA article and find it appealing, maybe what we are looking for and could be a win for all stakeholders and patients as well.


schmidt107
Comments3 | + Follow
I don't comment much here but I have been a shareholder for more years than I care to admit. I have always held on believing in the science but always being disappointed in the resulting share price. I humbly repost this comment from another article.
simil
Comments37 | + Follow
A modest proposal….
Shareholder activism is a burgeoning business niche and since the early 2000s the dynamics have changed nearly 180º.
Generally, an activist firm has a staff of financial specialists who search for a company in which they can improve one or more areas of execution. After conducting detailed analysis, the activist will buy a stake (1% - 10%) in the target company and then make contact directly, collegially with the management or board.
Some of these activist firms are open to entrées from groups of small individual investors who know the target company thoroughly.
Only as a LAST RESORT do the activists ever go public, to expose flaws in the company via the media. Altho activists will not get involved unless they’re willing to wage a proxy contest, it’s the very last thing they want to do. Such action not only tarnishes the target company; it diminishes the reputation and trust that the activist company relies on in dealing with all other companies. Instead, they go directly to the board of directors, well prepared in advance with the facts, projections, and a plan to get the company on a solid track.
These are firms and individuals of stature, with impressive CVs and track records. There are different styles, but there is consensus among them that, with a non-threatening approach, boards welcome their participation and appreciate their discretion. In contrast to the previous era of Raiders, these firms are long term investors, not hostile, looking to influence but not takeover the target, not looking for a quick profit. Several of them focus on ownership with a 20 year horizon and are only interested in assets that appear to be worthy of that. They may be very hands-on during the first couple of years and then let the board carry on, with less intervention.
One such company specializes in playing an active role with startups, usually under $2 billion in capitalization. They’ve built this business over the past twelve years. My hunch is that they will talk with us, and I nominate Ed as our spokesman, to contact them when the time is right. I suggest that might be Dec 11, allowing Dr. Scarlett time to surprise us… but, more realistically, allowing us time to develop a comprehensive presentation. Let’s skate to where the puck is going to be.
It’s time that we, who have studied imetelstat with passion and resolve, move from well-justified outrage now, toward forming a constructive plan to make our ownership of this company financially meaningful and to ensure that the broadest potential for imetelstat has every chance to reach the people who need its benefit.
Is there anyway we can start any kind of grassroots movement of some sorts here?
Even if it would be as small as stating which email to send our complaints to or couching us in the most appropriate way to construct the complaint.
Schmidt107
17 Dec 2018, 11:01 PM

Post Reply