PPS

[Gwikley]

Confusing, for sure.

[KTArsenal]

I'd like to believe that once the PDUFA is announced it should gain a bit of upwards momentum.

It's just an opinion, but I really believe that bluer skies lie ahead. Regardless what the PPS is currently, today's news was a really important step for suffering MDS patients.

[bucbeard]

Once we get the PDUFA date in 2 weeks, I suspect that the lead-up to that PDUFA date will resemble the volatile action that also lead-up to the last binary decision point, Sept of 2018.

The PPS will approach the same levels in the months prior to the JNJ "No" in 2018, $5-7, as short levels will no doubt be on the rise.

An FDA "Yes", gets us closer to $8-10.

just one man's opinion...

[KTArsenal]

There are major owners of this stock that can abuse the PPS with impunity.

Obviously, it'll continue until Geron can partner or sell imetelstat outright.

Wall Street is about MONEY IN THE BANK, PROFITS, AND THEIR MARGINS. Not potential. You and I are worried about a simple NDA acceptance. The reality is: Can Geron bring imetelstat to patients ON THEIR OWN without further dilution. Wall Street obviously says no.

That's why the PPS is where it is. Wall Street is about MONEY. We don't have enough of it to make it to commercialization without help.

Wall Street knows we'll be approved, without a doubt. Wall Street also knows that we'll be diluted further without help from a partner or buyout, and that's the current speculation that drags us down.

Nothing else makes sense.

Tell me I'm wrong. I've been wrong once before. Maybe twice

[rccola335]

actually sometimes they are about the potential - Gilead paid 4.9 Billion for a drug that just had its trials placed on hold- wonder what imetelstat could bring with MDS and MF utility - and if you add in other heme malignicies as a possibility the sky is the limit

[LWS]

New Information (Goldman Sachs Buy Signal)

1/ Geron Price Target Announced at $4.00/Share by Goldman Sachs September 12, 2023

2/ Geron Raised to Buy From Neutral by Goldman Sachs September 12, 2023
========================================

Time & Timelines:

The line of evidence: Conferences (ASCO, EHA), KOLs, Webinars, MD Anderson, NDA submitted, EAP, NDA accepted, timeline to NDA approval (continuing question). I see no more obstacles on the medical side.

[LWS]

The Goldman Sach's buy recommendation has not sent Geron's PPS higher, as anticipated. Certainly GS, with all of their inputs, is fully aware of Imetelstat's successes and its potential. The factors that are controlling Geron's PPS are obviously very strong and not well understood. It seems to me that the PPS is manipulated, computer controlled, and backed by some very deep pockets (whose & why?).

[LWS]

I have no idea how high Geron's price can go. There are many factors besides medical. From a medical standpoint, Imetelstat has been accepted and approved. It is all over. Imetelstat is a very good blood cancer medicine that is needed today.

The FDA has recently granted one form of approval for Imetelstat (EAP--- Extended Access Program). Any person with MDS qualifies for treatment with Imetelstat, as I understand it. As I see it, the EAP program is in place now to address the immediate needs of MDS patients, while the ADCOM program gets organized for the FDA/NDA approval.

[Gwikley]

Strange that the market does not react to the latest EU development. Still losing 2-3% a day. As if nothing happened at all.

[rccola335]

that was not a surprise and if anything - hearing that it was going to be 14 months to be reviewed was a little disappointing

[kmall]

The only things that will propel the SP are approval (s), a merger or buyout. Geron's cash burn is the 800lb gorilla in the room and the only way to feed it is through dilution until commercialization is fully realized. This will take many more years. In the meantime competition grows. Perhaps I'm wrong? Wouldn't be the first time. -Kmall

[LWS]

The only things that will propel the SP are approval (s), a merger or buyout. Geron's cash burn is the 800lb gorilla in the room and the only way to feed it is through dilution until commercialization is fully realized. This will take many more years. In the meantime competition grows. Perhaps I'm wrong? Wouldn't be the first time. -Kmall

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The EAP is in place as an interim solution until the ADCOM/FDA can get organized and receive the overwhelming evidence from successful trials, KOLs and patients. The timeline is flexible, based on patients’ immediate needs. The adjectives still apply (“compelling, remarkable, durable, etc.”).

Telomerase, telomeres, cancer stem cells and disease modification are proven to be closely connected. Approval of the NDA is a necessity and seems to be a “given” now. Partners, in some form, are likely. JNJ and AbbVie certainly know everything about Imetelstat (successes and potential going forward).

[LWS]

ADCOM is the next chapter

Two different worlds:

1/ Imetelstat excels (Medicine & Science)

2/ Imetelstat fails (PPS, Investors and Market forces)

The final chapters are yet to be written

[Ryan]

My guess is the Institutional ownership will be 80% before the stock makes a move up. Rangebound from $1.90-$2.30 or so until then.

Interesting new topics about the FDA, EMA, Thio drug still in early stage trials, etc… no comments on all of that info as I am just waiting for approvals at this point.

With a defined time frame, there is no real catalyst to push this stock. I had thought ASH would allow for a ‘shining moment’ for Imet Phase III as well as updates on other trials, but the conversation here dampens my expectation there, pretty thoroughly.

Copypasta is a creative word. It’s definitely true that LWS repetitiveness is repetitive and that non-stop over and over does diminish any impact from any of the factual (many, many) points, repeated over and over and over … (and over)…. Nonstop scroll of repeat messages stated in different ways…. And the beat goes on.
(“So it goes”, Kurt V)

[LWS]

From Ryan --- It’s definitely true that LWS repetitiveness is repetitive and that non-stop over and over does diminish any impact from any of the factual (many, many) points, repeated over and over and over

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What you say about my postings is true. The information is accurate (as far as I can tell), but it has been repetitive. Somethings are worth repeating for emphasis and continuity (judgement call).

I still believe that Imetelstat is a very important blood cancer medicine ("compelling, remarkable, durable, etc."). I also believe that ADCOM will get that point across to all (KOLs, investors, patients ,etc.). The PPS (under $2) is hard to explain. The waiting game and the frustration continues.

[KTArsenal]

"Somethings are worth repeating."

Not so much. That sentence in itself proves it.

[LWS]

In limbo ---waiting, wondering and hoping

As far as I can tell, there is nothing but good medical news (trials, KOLs, conferences, publications) concerning Imetelstat. The EAP is an impressive achievement, reflecting the FDA's high regard for this medicine, before granting final approval (for NDA). The extremely low (PPS) is a mystery to me. Everything seems to be on the 'up and up' as far as the science and this medicine is concerned. That is a totally different subject from Geron's business practices (good, bad or indifferent), which many are focusing on.

Nothing will matter very much about the (PPS) moving out of the doldrums, until there is a new, important partner (or buyout) and/or an approved NDA. In the meantime we have the EAP (allowing access to Imetelstat now) and the critical ADCOM for Imetelstat (date & agenda TBD) to ponder. At $1.75 we can only wonder about what is influencing and controlling the (PPS), which entity (human or computer) seems to be totally unaware of and disconnected from Imetelstat's successes, immediate needs, and potential (combinations and synergies).

[LWS]

Buy Geron --- Beaten-Down Stock -- Goldman Sachs Says

Geron Corporation (GERN)

Let’s first head to the biotech space and take a look at Geron, a late-stage clinical biopharma company primarily focused on developing innovative therapeutics for the treatment of blood cancers. Geron has gained significant attention and recognition for its pioneering work in the field of telomere biology. Researchers at Geron introduced an innovative method involving oligonucleotides, which are brief, synthetic DNA or RNA strands, to impede the functioning of telomerase, an enzyme responsible for preserving telomeres and facilitating the ongoing growth of cancerous cells.

Investors seeking opportunities in biotech know that it’s all about upcoming catalysts, and Geron has a big one coming up next year.
The company’s flagship product candidate is imetelstat, a telomerase inhibitor that has shown promise in clinical trials for hematologic malignancies, such as myelodysplastic syndromes and myelofibrosis. Following encouraging Phase 3 results for the study targeting transfusion-dependent anemia in patients with lower-risk myelodysplastic syndromes (MDS), the company’s marketing application for imetelstat has been accepted by the FDA, and a PDUFA date has been set for June 16, 2024.

The shares, however, have been on the decline in recent times, falling by ~53% since June’s yearly high. This decline has occurred in the backdrop of another development – the recent FDA approval for the label expansion of Reblozyl, advanced by Bristol Myers Squibb and Merck as a first-line option for anemia in adults with MDS.

Nevertheless, Goldman Sachs analyst Corinne Jenkins does not see this factor impeding imetelstat’s success. She claims that investors should seize the opportunity now that shares are at such a low level.

“Based on our review of the data, conversations with KOLs, and regulatory precedent, we maintain our view that imetelstat is likely to be approved in this setting, where we estimate $1.5B in unadjusted peak sales (PoS: 90%),” Jenkins said. “Further, the recent approval of Reblozyl in frontline LR-MDS across a broad population (RS+/-) does not negate the blockbuster opportunity for imetelstat in the second-line setting, in our view. Thus, we see the recent pullback in shares as presenting a buying opportunity for the stock.”
These comments underpin Jenkins’ Buy rating while her $4 price target makes room for big upside of ~130% in the year ahead. (To watch Jenkins’ track record, click here)

It looks like all other analysts feel the same way. The stock claims a Strong Buy consensus rating, based on a unanimous 5 Buys. Moreover, the $4.80 average target is even more bullish than Jenkins will allow and set to generate 12-month returns of ~173%. (See GERN stock forecast)

[LWS]

While we wait for fireside chats, an ODAC (Oncology ADCOM) review, and ASH2023 we can speculate a bit about the very low PPS.

1/ This is the middle of tax loss season, and many have losses in Geron's stock
2/ As a 'one -trick -pony' small biotech, Geron is a 'playground' for hedge funds
3/ Naked shorts are out of control
4/ Some believe that Imetelstat successes have been exaggerated and will be rejected by the ODAC or the FDA
5/ Others want to wait and see what the ODAC public hearings bring (not on schedule yet)
6/ Some believe that dilution is an important factor

IMHO, the ODAC public hearings will be very favorable for Imetelstat, which will pass from the current EAP working status to NDA approved, very smoothly. We will wait and see.

[LWS]

Prediction:

Sometime between today (November 16) and the end of this year (2023) Geron's PPS will be over $4.00. This is based upon publications in prestigious medical journals, KOLs, and ASH2023 (December 9-12). The EAP is in place, MD Anderson continues use and research, and ODAC has accepted the NDA for review. There are no known important medical negatives for Imetelstat. There are numerous positives coupled with patients' immediate needs. With ODAC recommendations and FDA approval, the PPS will easily be in double digits.