Similarities......Pt. II

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kmall
Posts: 754
Joined: Thu Mar 21, 2019 3:57 pm

Similarities......Pt. II

Post by kmall » Sat Sep 03, 2022 4:51 pm

Back in Febuary of this year, I posted a summation of Geron in comparison to Forty-Seven Biotech, on several levels, which was subsequently acquired by Gilead for $4.9B.

http://imetelchat.imetelstat.eu/imetelc ... f=1&t=1274


In the year prior to it's acquisition by Gilead, Forty-Seven had a flurry of hiring activity coupled with inducement grants. Very similar to what we have witnessed in Geron these past 3+ years, with the majority of Geron's newest hirings post 10/2018 being in the last year or so. Another similarity perhaps?

When this was originally posted in February of this year, Geron's Market Cap was $328Million and they had approximately 80 employees. This past week we witnessed Geron surpass a $1Billion Market Cap.....the first time since September 2018, when a decision for the potential future collaboration with JNJ had yet to be decided. I would say that this past week marks an epic milestone for both the company and it's investors.

Just as noteworthy is the addition of 10+ new employees since this initial February 2022 posting, raising Geron's count to 90+ employees, 5-10 greater than originally anticipated by Olivia Bloom in 2019, which according to Geron, would be "necessary" for the ultimate fulfillment of company approval/commercialization objectives. I'd like to add that there are still 6 job listings on the Geron website as of this time, and at least 4 which have recently been filled, but yet to be announced.
https://www.geron.com/careers/opportunities/

A few of the additional 10+** new employees added to the Geron roster since January of 2022 include:

1 - F Matthew Bakthasekaran - Sr Manger, Clinical Program Management - 2022

2 - Judy Ho - Sr Manager, Clinical Science - 2022

3 - Kate Turner - Associate Director Clinical Operations - 2022

4 - Janet Ahern(+) - Clinical Research Consultant - 2022

5 - Jason Grossman - Ex Director, Commercial Operations - 2022

6 - Jeff Braziunas - Sr. Director, US MA Strategy & Field Medical Excellence - 2022

7 - Christopher Cornell - Sr. Field Medical Liaison - 2022

8 - Aron Feingold - VP Investor Relations & Corporate Communication - 2022

9 - Dave Clark – CPA, Corporate Controller - 2022

10 - Katherine Harmon, CPA, Assistant Controller - 2022

11 - Ben Thorp - Head of Clinical Data Management - 2022

12 - Tim Tickner – Director, Supply Chain Management – 2022

13 - Ronan Balicanta* Senior Manager, Submissions (UK) - 2022

14 - Tarin Araujo - Senior Manager US - 2022

15 - John Albert - Director Information Technology Infrastructure - 2022

16 - Jennifer Allen - Associate Director, Talent Acquisition – 2022

17 – Fiona McAuliffe – Talent Acquisition Associate - 2022

(+): Consultant
*: Former Janssen employee

**Several employees have since left Geron during this time period (Jan 2022-present), which would mark the 80 to now 90 total "known" employee count reflected in the 17 new employees listed above.

In a revision of my original post Similarities.....we can add yet another strong comparison between these two Biotechs. Inducement grants. Inducement grants for new employees are a recent trend among up and coming Biotechs to preserve capital funding while providing growth for future company objectives.

https://humancapital.aon.com/insights/a ... 0necessary.

"....inducement grants allow companies to circumvent the share limitations of their equity plans, thus allowing companies to fuel their growth without having to ask shareholders to approve additional shares more often than necessary."

It is my firm belief and OPINION ONLY, that Geron is a strong candidate for a potential acquisition in the very near future.

Much, much stronger than 7 months ago in fact.

If Forty-Seven could be acquired by Gilead for $4.9B, on the back of it's drug Magrolimab, then I could see Geron receiving offers many, many multiples over that for Imetelstat, if.......and that's a BIG IF.....positive results for Imetelstat in Pre-Clinical Lymphoid Malignancy studies at MD Anderson are revealed by the end of this year.

Couple that with the upcoming P3 IMerge TLR in January 2023 and subsequent FDA/UK/EMA NDA's to follow, it would most likely - again just my
opinion - be in some Big Pharma's interest to make a play for an acquisition here, to retain or even gain potential revenue stream in Oncological disorders, across the space - Hematological/Sarcomas/Carcinomas/Lymphomas

From a few of Geron's patents I read earlier this week, it looks as if they have covered all of the above mentioned as potential telomere treatments in the future:

https://patents.justia.com/patent/10196677

"In an aspect of the method, the cancer is selected from the group consisting of breast cancer, colon cancer, lung cancer, prostate cancer, testicular cancer, gastric cancer, gastrointestinal cancer, pharynx cancer, rectal cancer, pancreatic cancer, cervical cancer, ovarian cancer, liver cancer, bladder cancer, cancer of the urinary tract, thyroid cancer, renal cancer, skin cancer, brain cancer, leukemia, myeloma and lymphoma."

"A variety of cancer cells have been shown to be telomerase-positive, including cells from cancer of the skin, connective tissue, adipose, breast, lung, stomach, pancreas, ovary, cervix, uterus, kidney, bladder, colon, prostate, central nervous system (CNS), retina and hematologic tumors (such as myeloma, leukemia and lymphoma). Targeting of telomerase can be effective in providing treatments that discriminate between malignant and normal cells to a high degree, avoiding many of the deleterious side effects that can accompany chemotherapeutic regimens which target dividing cells indiscriminately."

"The cancer should also be one that is responsive to cancer-cell inhibition by telomerase inhibition. As noted above, oligonucleotide telomerase inhibitors, as exemplified by GRN163 and GRN163L, have shown inhibitory activity in vitro against human kidney, lung, pancreatic, brain, colon, prostate, breast, leukemia, lymphoma, myeloma, epidermal, cervical, ovarian and liver cancer cells, and in vivo, via local and systemic delivery, against human brain, prostate, lymphoma, myeloma, cervical, lung, and liver cancer cells. Other preferred targets include small cell lung, esophageal, head and neck, and stomach cancers."

https://patents.justia.com/patent/9951389

"A variety of cancer cells have been shown to be telomerase-positive, including cells from cancer of the skin, connective tissue, adipose, breast, lung, stomach, pancreas, ovary, cervix, uterus, kidney, bladder, colon, prostate, central nervous system (CNS), retina and hematologic tumors (such as myeloma, leukemia and lymphoma). Targeting of telomerase can be effective in providing treatments that discriminate between malignant and normal cells to a high degree, avoiding many of the deleterious side effects that can accompany chemotherapeutic regimens which target dividing cells indiscriminately."

"The oligonucleotide GRN163 administered alone has shown inhibitory activity in vitro in cell culture, including epidermoid carcinoma, breast epithelium, renal carcinoma, renal adenocarcinoma, pancreatic, brain, colon, prostate, leukemia, lymphoma, myeloma, epidermal, cervical, ovarian and liver cancer cells.

The oligonucleotide GRN163 has also been tested and shown to be therapeutically effective in a variety of animal tumor models, including ovarian and lung, both small cell and non-small cell (see, e.g., U.S. Pat. No. 7,998,938, the disclosure of which is incorporated by reference)."

Many prolific posters I have read lately on other forums have made claims that Geron is "not for sale".......and while that may very well be the case, I pose this question:..........
Last edited by kmall on Sun Sep 04, 2022 11:10 am, edited 3 times in total.

kmall
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Re: Similarities......Pt. II

Post by kmall » Sat Sep 03, 2022 4:52 pm

Are any of you familiar with the game Poker?

If you know you have a winning hand, do you reveal your holdings prematurely? Or do you wait for the pot to grow exponentially and take advantage of weaker hands around the table?

For those of you claiming that Geron will go it alone, and follow a regimated statement served up on company PR's, Conference Presentations and slides, have you considered that perhaps Dr. Scarlett is posturing for a better offer and more time as he waits his hand out while his winning pot grows exponentially?

Just something to consider as we watch momentum and interest grow from the sidelines in the upcoming months.

Personally, I believe for the patients.....most important in this overall scenario, and shareholders secondly, that our best case is a Buyout by Big Pharma. Preferably a stock swap from a solid company who pays quarterly dividends, which a prudent investor would then reinvest for maximum gains over time.

While I understand the ability of "going it alone" and the potential it holds, ie; Amgen (est.1980/MC
$130B) - this day and age - 2022 - is much different than even two decades ago, let alone four, and "going it alone" presents a litany of obstacles for both patients and investors alike. While a fantastical notion, and certainly not out of Dr. Scarlett's wheelhouse, I see the path of least resistance as one that is more prudent and beneficial for almost all involved in the ongoing saga that is both Geron and Imetelstat. -Kmall

bucbeard
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Re: Similarities......Pt. II

Post by bucbeard » Sat Sep 03, 2022 5:23 pm

If JnJ is truly still in the house, and many including myself feel this to be true, then the bidding starts at $5B at a minimum. This was their stated estimated valuation on public slide decks prior to discontinuation. In the years post-discontinuation, Geron appears to have done a nice job of increasing the value of Imetelstat as a platform drug and potentially a diverse set of indications, as well as IP and related patents. It seems logical to believe Geron can make a realistic case of a current valuation to be between $7-10B for a buyout.

They need to prepare, communicate and execute as if they are going it alone...which they are doing with intent. At some point and sooner rather than later, especially as we get closer to D-day, Big Pharma in this space will step forward with more meaning offers before the $7-10B buyout becomes a reality of $15-20B.

kmall
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Re: Similarities......Pt. II

Post by kmall » Sun Sep 04, 2022 2:26 am

@bucbeard....I'm in the same camp as you in thinking that JNJ never truly left the picture. The most obvious reasons being.....

#1 - Dr. Rizo and the majority of the Imetelstat development team under Janssen migrating to Geron within 4-6 months after the discontinuation decision 9/27/2018.

#2 - The NJ Satellite office a stones throw away from JNJ Headquarters.

#3 - And possibly the biggest clue of all, the hiring of Nishan Sengupta - VP, Market-Access, Pricing, Evidence Strategy, Geron Corporation, who was hired in August 2021 and is also currently employed at JNJ as Global/US Access Strategy Lead-IMBRUVICA, B-Cell, Rare Hematology, holding that title since August 2019. Prior to this he was JNJ Global Market Access Leader -Oncology/Hematology from Jan 2012 - Aug 2021.

Coincidence?

Highly doubtful.

Why would an employee of this caliber be in a crucial position for Geron, while playing a dual role at JNJ as Global/US Access Strategy Lead-IMBRUVICA, B-Cell, Rare Hematology if JNJ wasn't still in the picture?

And I also think it's impossible for him not being aware of the Geron/Janssen collaboration/discontinuation prior to accepting such an important position at Geron. You'd have to be living under a rock in Antarctica not to have known about that one......wouldn't you say?

Coincidence #2......the B-Cell in his job title.
"B-cell lymphoma is a type of non-Hodgkin lymphoma that originates in the B-cells. It is the most common type of lymphoma and about 85% of all lymphomas in the United States are B-cell."

The next possible catalyst on the Geron calendar just happens to be the Pre-Clinical Lymphoid Malignancy studies from MD Anderson due by the end of the year.

Coincidence #3.....Dr. Rizo's prior experience at Janssen with Lymphoma and all P1 myeloid assets, and Global Clinical Leader for all late-stage myeloid assets, including Imetelstat. Dr. Rizo was also Global Clinical Leader for the ibrutinib mantle cell lymphoma (MCL) program and was responsible for all MCL studies led by Janssen. During her initial tenure with Janssen, Dr. Rizo worked on a variety of Velcade clinical trials in lymphoma and multiple myeloma.

So now Geron is currently sitting with JNJ's Global/US Access Strategy Lead-IMBRUVICA, B-Cell, Rare Hematology leader...... while Dr. Rizo retains a role, being a consultant as Senior Medical and Regulatory Advisor at Geron......who's expertise includes Lymphoid Malignancies - and she just happened to be the Clinical Global leader for ibrutinib (IMBRUVICA) while at Janssen - as Geron waits for Pre-Clinical study results from one of, if not the most prestigious cancer institutions in the world to conclude in approximately 3 months from now and a mere month before P3 IMerge TLR are revealed.

Coincidence???

I think not. There's a higher probability of me selling you the Brooklyn Bridge tomorrow then all of those circumstances being purely coincidental.

But then again, this is Geron, so just about anything is possible, right?

And like you, I believe if a Buyout comes to fruition, it will be substantial, however, I believe your top estimate is extremely conservative considering the extent Imetelstat may play in future Oncological treatments.

Of course, IMO -Kmall
Last edited by kmall on Sun Sep 04, 2022 11:44 am, edited 3 times in total.

kmall
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Joined: Thu Mar 21, 2019 3:57 pm

Re: Similarities......Pt. II

Post by kmall » Sun Sep 04, 2022 4:32 am

Sidenote: it appears as if ST Pharma's new Oligonucleotide facility in Banwol, Korea has passed USA FDA Inspection as of August 1, 2022.

In case anyone here doesn't recall, ST Pharma in Korea was the manufacturer of Imetelstat for the duration of the P2 IMerge and P2 IMbark Clinical Trials under the Geron/Janssen collaboration.

http://www.koreabiomed.com/news/article ... dxno=14300

"ST Pharm has been only able to export raw materials of oligonucleotide treatment for clinical trial use to the U.S. so far.

However, the cGMP approval by the U.S. regulator has enabled large-scale exports for commercial use, the company said.

ST Pharm expects four FDA PAIs by the first half of 2023. This means FDA approval for novel drugs that ST Pharm supplies raw materials could be imminent.

The company said that the cGMP approval would bring a positive impact on future inspections and that ST Pharm’s sales would also increase should the novel drugs succeed in commercialization."

https://www.stpharm.co.kr/en/pr/all/st- ... by-usa-fda

This all seems to bode well for the future manufacturing/commercialization of Imetelstat.
-Kmall

biopearl123
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Re: Similarities......Pt. II

Post by biopearl123 » Sun Sep 04, 2022 8:04 pm

Dern right! Getting FDA approval means business. I have seen the FDA shut down entire production lines for a piece of cardboard where it didn't belong. This high standard protects us all and is very hard to achieve. It bodes well for glitchless free Imetelstat production. Kmall, you are not of this world. Thank you are all your hard work and the quality research you bring to all of us. bp

jingledsassy
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Re: Similarities......Pt. II

Post by jingledsassy » Mon Sep 05, 2022 1:16 am

Kmall and Bp....Leaders of the pack....I think we are getting some traction.....Land Ho!!!!....

kmall
Posts: 754
Joined: Thu Mar 21, 2019 3:57 pm

Re: Similarities......Pt. II

Post by kmall » Mon Sep 05, 2022 8:02 am

@Bp & Jingledsassy......

Not that I know for certain, but if Geron is continuing to subcontract ST Pharma for the manufacturing of Imetelstat, it is interesting that:

"ST Pharma expects four FDA PAIs by the first half of 2023. This means FDA approval for novel drugs that ST Pharm supplies raw materials could be imminent."

This is approximately the same timeframe Geron expects to submit FDA NDA for Imetelstat. As bucbeard mentioned earlier in this thread, Geron has certainly proven intent of "going it alone" if necessary. And from the wording of the ST Pharma PR, it sounds as if ST Pharma's intent is to produce a vast amount of oligonucleotides - which Imetelstat as you know is one of - for "large-scale exports for commercial use" to the US.

Judging by this 11/29/21 article - ST Pharma's expansion will go from a capacity of 1.5mole to 6.4mole.....to eventually 14mole with the addition of a second manufacturing facility.

https://www.contractpharma.com/contents ... -facility/

"In 2018, ST Pharm established its first oligonucleotide plant at Banwol campus with a production capacity of 1.5 mole per year. In 2020, the plant underwent further capacity expansion and when completed, ST Pharm will have a production capacity of 6.4 mole per year.

The establishment of the second oligonucleotide plant will provide a production capacity of 14 mole per year, which places ST Pharm among the world's largest CDMOs in oligonucleotide production in 2025, in terms of capacity"

For those of you who can/care to calculate the "mole" capacity rate for oligonucleotides into kilograms:

https://pubs.acs.org/doi/10.1021/ed5007376

For a layman, like myself......1.5 to 14 is approximately 9.33x greater.............


In terms of an ever-increasing market potential for Oligonucleotide therapy over the next 4yrs.......

https://www.prnewswire.com/news-release ... 32667.html

"Research & Market expects a rapid growth in oligonucleotide therapeutics market from $7.15 billion USD in 2021 to $18.8 billion USD in 2026 at a CAGR of 21.4 %. (Reference: Research and Markets, 2021, Oligonucleotide Synthesis Market Research Report)."

For a layman like myself, $7.15B to $18.8B is approximately 2.63x greater.............

Land Ho!!!! -Kmall

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