Slides are up

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phil
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Slides are up

Post by phil » Tue Feb 23, 2016 2:31 pm

I read the slides (Up 30 min early) and not much new other than things are on the same path with no delays. I am impressed that MDS has ramped up much faster than MF, probably because a few pieces were set in place by the start of the MF trial. I am also impressed that John has responded so well with his second round of treatment, that shouldn't be overlooked that the body seems to not resist the second treatment, as it does with other drugs.

The patients in the MF trial have a short life-expectancy of just 6 months, according to Chip. Should they respond to treatment as the patients at Mayo did, I and expect many will, then that data will be known by the end of this year and would certainly be cause for expediting the FDA process with BTD or similar.

I don't expect an opt in until 2017 with read-out is complete, but have confirmed with Geron management that JNJ can proceed with as many trials as they wish in the meantime. I expect AML and first-line MF trials to start later this year. All seems on course with no delays!

Fishermangents
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Re: Slides are up

Post by Fishermangents » Tue Feb 23, 2016 2:44 pm

Hi Phil, thanks for your post. Is there a direct link to the slides? It's not on Geron's website. You can post it here.
And also: have you also found the JnJ slides for today?

phil
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Joined: Wed Dec 09, 2015 2:53 pm

Re: Slides are up

Post by phil » Tue Feb 23, 2016 3:28 pm

The JNJ presentation starts in 45 minutes. I had access to the Geron slides via RBC and posted. The JNJ slides aren't up yet. I think the Geron presentation went as expected and noted Chip was "unapologetic" for saying imet was the first and only drug to induce remissions- great to hear. I have been repeated saying on SA that the final read-out and opt-in by JNJ won't be until mid 2017, but JNJ can and will run other trials in both AML and I expect first-line MF. Those will probably start end of 2016 and would be important news.

Hearing all good and a few PRs already from a couple MF patients and maybe some CR, although it's all second hand rumors. I think the trials are going very well and JNJ very excited. I also think the 4.7 dose was meant to prove to the FDA that 9.4 is needed. 4.7 probably won't get the same response that 9.4 gets, so I expect 4.7 to move to either 7.5 or go to 4.7 but maybe more frequently? that's a guess. All is good and patient enrollment seems to be picking up.

Fishermangents
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Re: Slides are up

Post by Fishermangents » Tue Feb 23, 2016 4:39 pm

Phil: where did you post the slides? I don't see them. You can post links here. I then can make them available here and through the imetelstat.info website.

2pongz
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Re: Slides are up

Post by 2pongz » Wed Feb 24, 2016 12:55 am

Greetings everyone, just finished viewing the slides. I'm a newbie to biotech investing and haven't followed Geron that long, so I apologize for this rookie question. Which is the most likely choice for JNJ, Opting in or Opting out? (SA crowd seems to think JNJ would likely to Opt in, I am curious, what if the opposite happens) If they Opt out, what would be the effect to Geron's pps?

Fishermangents
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Re: Slides are up

Post by Fishermangents » Wed Feb 24, 2016 1:50 am

Pongz, thanks for your post. First: it is Geron who will decide to opt in or -out. JnJ will take the continuation decission (see earlier posts in this forum to learn more about this). Secondly: predictions about pps are very difficult and notoriously unreliable, even when based on the things we know. So bringing in unknonws and what-if's makes any prediction even more speculative and therefore pretty useless. I don't dare to say anything about pps, just that I think that a strong and sustainable partnership with JnJ will be positive for the further development of imetelstat. Your question is more or less equivalent to the question: 'What happens if imetelstat fails?' The answer is obvious, don't you agree?

The most important is that everybody makes his/her own personal judgement whether a positive continuation decission is likely or not. Current facts on imetelstat (3xODD, existing proof of efficacy and safety, NEJM confirmation, expanding trials, JNJ's presentation of imetelstat in their top 10 new blockbuster drugs etc.etc.) make me believe that a positive continuation decission indeed is a rather likely thing to happen.

2pongz
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Re: Slides are up

Post by 2pongz » Wed Feb 24, 2016 4:17 am

Fishermangents, thank you for clearing my confusion. I need to read more about Geron and Imet since what we have right now is very promising.
Keep up the good work gents.

phil
Posts: 16
Joined: Wed Dec 09, 2015 2:53 pm

Re: Slides are up

Post by phil » Fri Feb 26, 2016 3:16 pm

In regards to the continuation decision... I had posted 3-4 times on SA that JNJ won't go "IN" until mid 2017. They have an option, and like any option, you have very little incentive to execute or exercise it early, so they will wait for the readout in mid/late 2017. HOWEVER, I have also noted that it doesn't really matter. JNJ CAN AND WILL run other trials. I expect AML and then front or firstline MF to follow, with AML being a combo of some type, maybe with JNJ's DOXY?.

A private investor from SA asked this question on the CC and Scarlet confirmed exactly that, so it was nice for some investors to hear it directly. JNJ is very excited about their drug imetelstat. I think there is much concern based on GERN's share price, as with the drop in price, investors "assume" something is wrong- I know I often do too. It's just that the market has had a severe correction and the biotechs have had a much worse correction, so everybody panics and assumes the worst. Good investors take these events as excellent buying opportunities and accumulate at low prices.

I always go back to 7 out of 33 getting remission in this bone marrow cancer, MF. Chip was "unapologetic" in repeating theirs is the ONLY drug to do so, the ONLY drug to EVER induce remission. I know the number of patients "N" is just 33, so the %s will be a little bigger or a little smaller when JNJ does their trial, but statistically, there just have to be repeat remissions in this new trial at a similar percentage. So I hold tight and wait for that...

Ligas3
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Re: Slides are up

Post by Ligas3 » Sat Feb 27, 2016 6:29 am

Hi guys. Nice to be on a board other than yahol which has been taken over by crazed shorts and seeking alpha which some have taken over to talk about general market conditions.

I was wondering if anyone might have the time to shoot an eloquent email over to Geron and suggest Scarlett talk with investors at some point what the data for non CR/PR/CI patients that had some response, albeit not a CI, such as resolution of symptoms and blood counts. No one talks about the 77% symptom response rate reported in the initial Mayo study. The benefits have to provide some sort of progression free survival. The market for Jakafi R&R patients looking for something to at least provide symptom response has to be huge. Scarlett never talks about how these benefits apply in a clinical setting or how they affect the value of IMET. IMET's $ value in MF will be tiny if only patients who have CR or PR take the drug. However, if Jakafi R&R patients take it to provide what Jakafi provides to patients who do well on it, well that is where the $ is at. Take Pacritnib for instance. Patients with anemia had no options because Jakafi causes issues with anemia. They were excited about it and asking for the hold to be removed for those benefiting. Imetelstat also had very good anemia response numbers. I feel like not only is this a topic for investors, but it may help recruit patients. Right now they look at the Mayo study and say "is it worth the risk, if I only have a 15-20% chance of remission. They don't consider the other benefits. Who can blame them? Most of the patients that did come forward in the Mayo study that had benefit are very quiet and have been for some time. I believe that the responders were told not to share their story with others because when the trial was underway and people started responding, there was some info shared. Then it all went quiet just like Geron got quiet. There just isn't much info out there for patients considering the trial.

Fishermangents
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Re: Slides are up

Post by Fishermangents » Sun Feb 28, 2016 1:43 pm

Hi Ligas, thanks for joining here! Although I really appreciate many of the SA contributions, I agree that there are too many general discussions, which for me are largely off topic. In addition, the message board is built around the articles. There are not many articles lately, which results in non categorized threads of 1200+ posts. On this forum we can categorize the topics (also after they have been posted) and even set up sub-forums if we like.

Now your comment itself. I feel your frustration because of the low pps. However, I am not sure if you are looking in the right direction for dealing with it. My take is that 1) Geron and JNJ are fully and total aware of what they are doing, 2) that JNJ never communicates widely about early stage drugs (they even don't send out press releases for the start of phase 2 trials...) 3) that the way they communicate is a well thought off and coordinated decision. So I am pretty sure that the email you suggest will not have any effect. The discussion you are suggesting will come when the time is there.

Development of new drugs just take a long time, because it is impossible to predict how the human biology responds without having extensive data. This is certainly the case with a new MOA, such as imetelstat. That's why Geron is such a nice target for shorters and manipulators. Your and other people's frustration is in fact creating the basis for that. We all know that Geron is MASSIVELY shorted, which started after the clinical hold. In addition, competition (such as INCY) doesn't sit still just to see it happen that their market is largely going to be taken away by a new and better drug. Thirdly, there are law firms that search for any word, letter or statement that they can use to sue a company and/or CEO. We have all seen that. I wouldn't be surprised if some of those law firms are actually being paid by shorting hedge funds or even competitors. The YMB is a very nice demonstration on how dangerous the outside world actually is for a new drug like imetelstat. It is not the kind of talk there, but what obviously is behind it.

I am not searching for excuses, because I agree that the current pps is very low. But certainly in this specific case I am quite comfortable with a CEO who doesn't talk too much. Law suites and other attacks on Geron can damage the JNJ relationship and the progress of imetelstat. If the CEO's strict communication protocol does help to prevent that, I will take it.

I prefer to stick to the things we have, rather to what we wish to get. And what do we have? Since the announcement of the partnership we are receiving a series of fully consistent messages about the progress of the trial(s), the promising performance of imetelstat ("a transformative drug"), two large clinical trials started within 12 months, JNJ publicly taking imetelstat in their top 10 new blockbuster drugs, and all the other things that are positive. Yes, there were no big new facts on the latest CC, but again all good things have been confirmed again. That's all I need to justify the waiting (and sometimes the adding to my position on the lows...)

Fishermangents
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Re: Slides are up

Post by Fishermangents » Sat Mar 05, 2016 12:44 pm

The slides of Geron's Feb 23 presentation at the RBC Captial Markets 2016 Global Healthcare Conference can be downloaded from the Geron homepage: http://www.geron.com/

Just take slide 3, where it says:
"Continuing clinical data indicate broad and transformative potential of imetelstat"

That's all I need.

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