ImetelChat

Round Of Applause For A Visionary Leader And A Look Back In The Rear View

Congratulations to Dr. Scarlett, Team Geron, Patients in the EU and the shareholders of Geron on this weeks confirmation of Orphan Drug Designation by the EMA. For now, I’ll keep the champagne on ice, however, it seems as if this is a major cornerstone towards global approvals. Unlike the FDA, the EMA consists of a conglomerate of European countries whose subsidized Healthcare systems lack the influence and corruption of politically and corporate lobbyists here in the U.S.
https://law.emory.edu/ecgar/content/vol ... ation.html

Orphan Designation will hopefully expedite the EMA approval process which averages 67 days.
https://www.ema.europa.eu/en/from-lab-t ... mmendation.

If this is the case, its no wonder Dr. Scarlett and Olivia Bloom stressed the manufacturing and commercialization of Imetelstat in last May’s CC – I pointed this out in my Go Big Or Go Home Series – Pt 1 –
“Yes. So, we have multiple years' worth of drug supply at this point and a very well-established manufacturing process.” – Dr. John Scarlett

“As you know, Imetelstat is contract manufactured out. And so, we have been validating all those vendors as part of the process in readiness for potential not only for Phase 3 trial supply, but also for potential commercialization down the road. And so those activities are ongoing right now.” – Olivia Bloom

It sounds as if Patrick Murphy has been quite busy since joining team Geron on 5/19/2019
https://ir.geron.com/investors/press-re ... fault.aspx

As you can see things are falling neatly into place for Imetelstat, although as an investor in GERN, I will be the first to admit that the timelines and hurdles thrown in our direction have been frustrating to say the least. However, Dr. Scarlett has proven time and time again that playing this game requires a great deal of patience and strategy.

One theory I would like to expand on and argue against – if you can call it that - is one that several of those who I hold in high regard when it comes to the saga of Geron and their quest to bring Imetelstat to commercialization believe in steadfastly. I won’t name names, and in the end, I know as much as anyone else – with the exception of those sitting around the Geron and J&J table.
I have been reading since the 2018 ASH P2 data was revealed that many of my fellow Geronimos believed J&J decided on discontinuation without a complete snapshot of P2 data. I find that a hard pill to swallow. It’s my belief that J&J knew exactly what they had and had a complete look under the hood of Imet up until that point. After all, the trials were complete and it seemed as if the team at Janssen were ecstatic with results and looking forward to the approval process. Let’s take a look back at a chain of events which all point to a business relationship which turned south and now most likely after all this time in our favor.

Hindsight is always 20/20 and for me many of the following developments weren’t necessarily clear at the time. Looking back, however they start making sense and, in the end, all start pointing to the brilliance of Dr. Scarlett as a leader and visionary in an industry where many fail to succeed.

I would say that as early as March of 2018 the J&J / Geron collaboration for continuation had turned sour. The main catalyst for this would be the departure of Dr. Rizo from Janssen.
https://www.linkedin.com/in/aleksandra- ... a-62553b2/

I keep going back to the Needham CC of 2019. On that call, Dr. Scarlett let us know that Janssen told him Imetelsat would be approved. I would assume that Dr. Rizo was with Janssen when he heard this; after all she was the Strategy and Compound Development Lead for the Imetelstat program.

It was about the time of Dr. Rizos departure that Adam Feurestein puts out his timely and now infamous “hit piece” with the “flimsy data” comment.
March 27, 2018 –
https://thefly.com/landingPageNews.php? ... val-claims

Someone was obviously tipped off to the trouble in paradise scenario which played out for the next 6 months. During that time a series of positive announcements kept hope alive for the common investor, including:

1. Imetelstat being at the top of J&J’s planned filings 2018 – 2021
https://seekingalpha.com/amp/instablog/ ... cology-nme

2. Pricing managers for Imetelstat in Europe, The Middle East and Africa
https://www.fool.com/investing/2018/08/ ... ews-f.aspx

It’s my belief that Dr. Scarlett had secured a round of funding starting in March of 2018 which would be the turning point in the make or break Geron story. His keen sense of business has kept us in the race and if not for this pivotal and most crucial move we would most likely be nonexistent today.
https://www.sec.gov/Archives/edgar/data ... 180331.htm

Pg. 22 -
“We may need additional capital resources in order to support the development and commercialization of imetelstat, especially if Janssen makes a negative Continuation Decision and we choose to develop imetelstat on our own,……”

A May 10, 2018 Quarterly Financial CC announced this round of funding and was highly criticized by many investors since it seemingly exacerbated what had already been a halting of the SP coupled with the Feuerstein hit piece 2 months earlier.
Maybe there were some ongoing negotiations over the next 5 months between Dr. Scarlett and J&J, however, its my belief that he had decided what course needed to be taken to avoid an inevitable implosion of the company. He knew the positive data from P2 which Janssen employees shared with him and the probability of Imetelstats approval. All he needed was the financial means to make it a reality. That round of funding secured our fate.

There is no way on Gods great earth that J&J didn’t know that P2 data either. We’re talking a Billion $+ deal + 20% royalties. That’s a lot at stake and they were banking on a low-ball offer coupled with Dr. Scarletts inability to go it alone and perhaps his willingness to take the check and walk off into the sunset. It has yet to be seen since the SP has struggled to even claw back 40% of where it was before Sept 27, 2018, however, as a long-term investor, I take Dr. Scarlett on his word when he says he intends to create long term value for shareholders.

Hey kmall , Martin here . I have often posted on the YMB that JNJ dropped Geron because they didn't have all the data . No 'offer' of any kind , just flat dropped the collaboration because IMbark grossly failed the Primary Endpoint of shrinking the spleen . They dropped Sept. 27-ish , BEFORE the final data was out . IMBark clinical cutoff , as reported in the ASH presentation , was Oct. 22 , therefore ~4 more weeks of MOS , which brought that Endpoint to an astounding 29.9 months , data so astounding that the FDA changed MOS to a high regard endpoint for ALL clinical trials a few months later . IMbark was the first indication Janssen started in Phase II and they may or may not have given equal weight to IMerge , which they started IIRC a couple months later . Regardless , they could NOT have known the final data in IMerge Sept. 27th because the clinical cutoff for that trial was Oct. 26 ! The data we all saw earlier that year in IMerge was abysmal , so I believe Janssen/JNJ Sept. 27 had no idea that in the next month the 8-week and 24-week TI rates would SOAR to 42% and 29% respectively and the transfusion reduction tally would hit 68% . I think all that data did actually accumulate late in the trial , as Imet has shown even with an 8- week median time to effect (.01-33.1) , maybe the higher time folks came in a rush at the end . If I'm wrong about the significance of the cutoff points relative to data gathering let me know , I do have the highest regard for your thoughts and especially your actions over the last couple years !
P.S. The YMB ban wears off after a few months !
P.S.S Fair winds and following seas !

Martin,
Thanks for the feedback, and yes you are definitely on the list of those I hold in high regard when it comes to thoughts on this company, drug and those who passionatley combat anyone spreading constant FUD regarding both of these. When the ASH 2018 data was revealed I too was like "Ahhh ha....got cha J&J." Deep in my heart I truly hope that, that is the case....even now. It would be poetic justice for leaving us at the alter. And yes, although I dont have those exact cutoff dates in my head, I do recall everything being razor thin as far as cliical trials go. And again, far from an expert on any of this, just a regular Joe with perhaps to much time on my hands; so my opinion is just that. But don't you think that a company like J&J who most likely has gone through very similar scenarios to the Geron collaboration dozens of times if not more would:

1. Know the cutoff dates and factor that into their CD time frame before signing on the dotted line?

2. Had almost 4yrs (Nov 2014 - Sept 2018) with this drug in-house. Wouldn't the development team have had a comprehensive analysis of efficiency by then?
After all, several members of the Janssen Imet team posted links to articles and well wishes on the future of Imet via LinkedIn in August 2018 (if I remember correctly). It just seems to me like a 4 week post "partnership" being the data linchpin is a bit of a stretch. Again, hardly an expert here so its not off the table.

3. Dr. Rizo walked in March of 2018. If I were a betting man, I'd say based on something other than "abysmal" results since within 10 months of leaving she's under the Geron roof leading the Imet program - perhaps she was "waiting" for ASH results as well?
Interesting how she leaves Europe for NJ via Celgene (Luspat) and whamo she's opening up an "office" in NJ to support the expansion of the Imet development team....coincidentally the same month or shortly thereafter her departure from Janssen, Dr. Scarlett secures funding to go independent if "need be" as reported in his May 10, 2018 Quarterly.

Maybe those 4 weeks caused the Ti rates to soar? But MOS was already 28.9 months if by Oct 22 we're looking at 29.9. Again, going back to Needham 2019 - somehow I'd love to find the transcript and post it, its out there - Dr. Scarlett says they (Janssen) told him Imet would get approval. Why drop Imet if you think its getting approved? 28.9 months is still 2x BAT. Maybe this is all a ploy by J&J, Geron, Dr. Rizo and now Dr. Gottlieb to get FDA approval while "hashing out a better deal"?...conspiracy theories anyone??.....many have suggested that J&J is still in the game. At this point nothing would surprise me - this saga seems to have more twists and turns then a who dunnit......and again a TON of speculation on my part. I tend to think a future ex-US partnership is where we're heading. Regardless of being correct or not, I felt it was a worthy topic of discussion. Again, best to you Martin and many thanks for your contributions on the YMB and now here! -Kmall

Hi Martin and Kmall, thanks for posting. I have to agree with Kmall that it is likely that Janssen knew exactly what they were walking away from, at least with regard to MF. I base this on a few things but mostly on knowing that data in the the MF study was evaluated on a "rolling" basis. In other words those patients that were enrolled early in the study were evaluated earlier as the study progressed and became data points in a fluid manner. They didn't leave the starting line all at the same time so the bulk of the data (but maybe not a small number of later enrollers) were available at the time of the walk. At the time of the walk, given its last second nature, either Janssen was truly ambivalent or Geron implored them to wait in case some miracle of data analysis occurred. When it became clear that the Janssen decision would also "include" MDS data which was not part of the original agreement, it suggested that Geron was trying to strengthen a (then) weak hand. Lots has changed since then but I have to believe Janssen's statisticians knew that MOS would be impressive even if they didn't have the last few patients to evaluate at end point (death), they at least knew how many were alive at the time of the walk. Could be they didn't care because they were looking for spleen reduction (thank you FDA), and thought MOS was a fluke or irrelevant. They also didn't have the RWD arm but did have their insurance data base that showed MOS of seven months that did not hold water with the FDA. But I agree they could not have known the depth of TI in the MDS study because that data did not yet exist. Either way things are looking pretty good right now. Just imagine if the duration of TI persists, it would make quite a (spl)ash at ASH. With regard to the FDA changing criterion to use MOS as a gold standard on the basis of Geron's data, this seems unlikely, using MOS as a standard appears to have been under discussion prior to the Geron reports and the FDA simply doesn't work that fast. Plus they haven't exactly paid Geron its props as far as I am concerned, much to the detriment of patients and the nations blood supply. Regards to you both, bp

I think the italian study which sunk the MOS claim that came out in August 2018 killed the deal - they didn't have time to investigate it to refute it - they weren't ready to marry Geron and declined

the scientific wing of Janssen was not in lockstep with the business side - i still remember the science people liking the article about Gerons big day and one of the lead scientists commenting that imetelstat was a strong compound - they were ready to go to market with it and had big plans - it may end up being a blessing in the long run that Janssen didn't opt in