The value of the retrospectoscope

[biopearl123]

I think one of the reasons we were so shocked by the Janssen walk was highlighted in a post by Kmall which referenced this J and J slide:

1. Does not include registrations where Janssen is not the study sponsor.
This information is accurate as of September 13, 2018 to the best of the Company’s knowledge. Johnson & Johnson assumes no obligation to update this information. Note: Filings/approvals assumed to be in US, EU unless otherwise noted.
24
APPROVED PRODUCTS
PRODUCTS APPROVED/FILED OR PLANNED FILINGS 2017-2021
EARLY-STAGE FOCUS AREAS AND PLATFORMS
(OUS)
(US) (OUS)
(US) (OUS)
(EU)
APPROVED/FILED
Oncogenic Drivers
• EGFR/cMET • PRMT5
• KRAS
Directed T-Cell Therapies
• CAR-Ts
• xCD3bi-specific
Comprehensive Regimens for Immune Therapy
• Oncolytic virus
• Antigen
presentation/pPriming
• Vaccines
• Checkpoint/Agonist combinations
IMBRUVICA®
• cGVHD R/R (US)^
• Marginal zone lymphoma^
• Waldenström’s macroglobulinemia combo^
• CLL front-line combo with obinutuzumab*
DARZALEX®
• R/R MM (EU)^
• MM R/R combo with
PomDex (US)^
• Front-line MM (non-transplant) VMP^
ZYTIGA®
• Hormone-naïve metastatic PC^
ERLEADA®
• Non-metastatic prostate cancer^
PLANNED FILINGS1
DARZALEX®
• Front-line MM (non-transplant) Rd • Front-line MM (transplant)
• Subcutaneous Rapid Administration • Amyloidosis
• MDS low/intermediate risk
• MM R/R combo with Car/Dex
IMBRUVICA®
• CLL front-line combo with rituximab • CLL watch and wait
• MCL front-line maintenance
• MCL R/R combo with venetoclax
• Follicular lymphoma R/R
• DLBCL front-line combination
• GVHD front-line
• Front-line CLL (IV fixed duration)
imetelstat
• Myelofibrosis
• Myelodysplastic syndrome low/
intermediate risk
ERLEADA®
• Chemo-naïve PC (+ ZYTIGA®) • Hormone-naïve PC
• Localized PC
• ERLEADA® fixed-dose combo
niraparib
• metastatic castration-resistant PC
• mCRPC combination
• Metastatic hormone-sensitive prostate
cancer combination
erdafitinib (FGFR inhibitor)
• Urothelial cancer
JNJ-4528 (BCMA CAR-T)
• Multiple myeloma
New Molecular Entities
Line Extensions

Unfortunately this slide did not copy well but the link is in Kmall’s post “The Irony of Retrospect”. On this slide Imetelstat was listed as a planned filing with a potential market of at least 1B with the company footnote stating that the information was accurate as of September 13, 2018. With the continuation decision deadline looming a few days away, it looked like a sure thing. Then came Sept 18th. So either J and J really did agonize until the last minute or else they lied in saying the information was accurate just a few days before. Giving them the benefit of the doubt and assuming the lawyers were able to review internal documents in researching the Junge class action case, (clearly if J and J misrepresented we would have one heck of a class action so it is probable J and J did not misrepresent,) it is not hard to see why many of us loaded up on this stock in 2018 only to be left at the alter, shocked and poor. Given the coincidence with the J and J talc cases it continues to be reasonable that Dr. Scarlett’s assessment that J and J did not have the “bandwidth” (I think he said) for the continuation, to be accurate. In looking through the retrospectoscope, it appears we may do just fine. I have always supported the thesis that the J and J walk could in the longer term add a great deal of value for us by “tainting” the drug and the company leading to a remarkably under valued stock. We shall see. bp

[kmall]

Bp - when looking back at what has taken place before and after the JNJ Discontinuation with Geron, it's difficult not to differentiate fact from coincidence. I'll try and do a brief outline here going back to March 2018. Keep in mind, that as of now the current Geron employee roster from what we "know" comprises approximately 13 former Janssen employees and probably an equal amount if not higher former JNJ employees. That's about 20-25% of Geron's current workforce between the two. This includes 2 CMO's, a CCO, more than a half dozen VP's including Clinical, Regulatory, Sales and the former Global/US strategy lead for IMBRUVICA from 2015 - 2021: Nishan Sengupta.

It's my belief that the "business" collaboration between the two companies fell apart months before the September 27, 2018 "decision" date starting with the departure of Dr. Rizo from Janssen. Again, SPECULATION on my part, but here are a few of the facts as we "know" them in chronological order. Again, I may not be 100% accurate here, and I don't have the time to do a deep dive research wise with additional links to some of this information, so if anyone can add to this discussion, especially links, or correct my recollection if incorrect on any points here, please do!!

* - no direct link

March 2018

1. Dr. Rizo leaves Janssen as Senior Director, Compound Development Team Leader, Clinical Oncology and goes to Celgene in NJ as Executive Director, Strategy and Clinical Lead, Clinical R&D where she stays for 11 months, until January 2019.

Celgene develops Luspatercept/Reblozyl for MDS.


2. Dr. Scarlett secures a secondary round of funding* in the event of a Non-Continuation with Janssen/JNJ and to meet Janssen financial obligations in the event of an "affirmative Continuation Decision" with Janssen/JNJ.

Pg. 23:
"RISKS RELATED TO OUR COLLABORATION WITH JANSSEN

We have outlicensed our sole product candidate, imetelstat, to Janssen. If Janssen discontinues the imetelstat program and/or terminates the Collaboration Agreement, our business and business prospects would be severely harmed, and we might cease operations, the development and/or commercialization of imetelstat would be terminated or substantially delayed, and the market price of our common stock would be adversely affected."

Pg. 27:
"Under the Collaboration Agreement, if we develop imetelstat independently under our own IDP, the success of that IDP depends on our ability to provide adequate financial and technical resources."

Pg. 31:
"Clinical development involves a lengthy and expensive process with uncertain outcomes. Current clinical trials of imetelstat being conducted by Janssen, including IMbark, IMerge and the Pilot Study, and potential future clinical trials of imetelstat may fail to demonstrate sufficient safety and efficacy of imetelstat to warrant further development of the drug, which could prevent or further delay regulatory approval and commercialization of imetelstat."

*All legal jargon/disclaimers, but none the less rather interesting wordage in hindsight.

https://fintel.io/doc/sec-gern-geron-10 ... h-16-17947


August 2018

1. Stephen N. Rosenfield, J.D. - Geron CLO sells a significant amount of Geron shares totalling just over $1,000,000.00* - from what I recall.

2. Robert J. Spiegel, M.D., FACP, Geron BOD sells a moderate amount of Geron shares - totalling less than $50,000.00* - from what I recall.

3. JNJ lists Imetelstat as an up and coming $1B /yr potential "Blockbuster" drug in it's development pipeline.

https://www.google.com/url?sa=t&source= ... 93StnDKRXr


September 2018

JNJ/Geron Discontinuation:

https://ir.geron.com/investors/press-re ... fault.aspx


January 2019

1. Dr.Rizo, former Janssen employee joins Geron as CMO.

2. Geron opens satellite office in NJ.

https://ir.geron.com/investors/press-re ... fault.aspx


April 2019

Dr. Faye Feller, former Janssen employee and current Geron CMO is hired. Laurie Sherman, former Janssen employee and VP Clinical Operations is hired.

https://ir.geron.com/investors/press-re ... fault.aspx


April 2019 - December 2019

Numerous former Janssen/JNJ employees including: Dr. Ying Wan, Sharon McBain, Libo Sun and Anil Kapur, amongst others join Geron.

https://ir.geron.com/investors/press-re ... fault.aspx

https://ir.geron.com/investors/press-re ... fault.aspx

https://ir.geron.com/investors/press-re ... fault.aspx


August 2021

Nishan Sengupta is hired as Vice President-Market Access, Pricing, Evidence Strategy at Geron. Prior to Geron, Nishan Sengupta was with JNJ for 17yrs.


November 2022

Scott Hutson former JNJ employee is hired as VP sales.

**I'm certain there are one or two other highlights I'm missing here. When I have the time, I'll try to compile a list of known current Geron employees who once worked for either Janssen or JNJ. -Kmall

[Ryan]

I think a low key highlight within that history was when Geron’s CRO, Paraxel, announced they were expanding facilities for manufacturing for Oligos.

[kmall]

Ryan - you are correct that the manufacturing facilities for Imetelstat originally contracted by Janssen/JNJ for the then P2 Clinical Trials IMerge and IMbark are most likely the same for Geron now. Although we are not 100% certain, since the company has made no announcement as of yet. However, ST Pharma in Banwol, Korea is the manufacturer, not Parexel. Parexel was the CRO (Contract Research Organization) for the P3 IMerge and IMpact Clinical Trials by Geron. From what I understand, Parexel's contract with Geron has ended.

A side note; the $25M ST Pharma facility expansion was announced in September 2021 and this past August that facility passed a rigorous FDA PAI (Pre-Approval Inspection) with flying colors.

https://www.google.com/url?sa=t&source= ... Np1DoERSBG

Looks like it's full-steam ahead in Korea and a great point to make Ryan! Thanks for the contribution. -Kmall

[Ryan]

Thanks, noted / corrected.

That is what I was referring to, ST Pharma, and their facility expansion. That was / is heartening news, for all the obvious reasons.

September 2021, thanks for refreshing the info, cheers.