Imetelstat Franchise

[Ryan]

The reference here, “will be renewed attention”

I think there is already ‘renewed attention’, since this comment combined with the “expected” peer reviewed publications (first milestone bullet point.

Since this is an external event for the company, it is clear (and obvious for many reasons) that the execs are fully aware of said peer-reviewed articles being written currently.

Now… referencing all this with the summation of Imetelstat as a franchise, leads me to believe / be quite sure that at least one, and maybe more, of these prestigious journals (should be NEJM or Blood) will be outside of the MDS or MF.

“As a result of robust and compelling data from IMerge Phase 3, we believe there will be renewed attention on telomerase inhibition as an oncology approach. Thus, we have positioned our exploratory programs in other hematologic malignancies to provide data over the next several years to add strategic value to the imetelstat franchise.”

[biopearl123]

Ryan, totally agree, I didn’t see your post before I posted about the likelihood of an NEJM article. Likelihood high.

[LWS]

“As a result of robust and compelling data from IMerge Phase 3, we believe there will be renewed attention on telomerase inhibition as an oncology approach. Thus, we have positioned our exploratory programs in other hematologic malignancies to provide data over the next several years to add strategic value to the imetelstat franchise.” --- from Ryan

Another way of saying this would be: The data is remarkable (robust and compelling), the NDA is completed and under review, fast-track approvals are assured, and patients' needs have never been greater. We can now move beyond single-agent blood cancers and develop, in combinations with collaborators and partners, treatments (and hopefully some cures) for many cancers that are classified as telomere/telomerase types (about 90% of all cancers).

[Gwikley]

Sorry to be so mundane. But there is a serious disconnect between the uplifting insights and observations about this drug...and the continued decline in the share price. Granted there are a whole host of reason for that...never the less... when commenting some years ago about the pedigree of Imetelstat, based on a Nobel prize winning discovery, a response stuck with me : .."the market does not reward for Nobel Prizes".

[LWS]

Sorry to be so mundane. But there is a serious disconnect between the uplifting insights and observations about this drug...and the continued decline in the share price.---from Gwikley

There is a major naked-short presence that has been successful (obviously) in controlling Geron's share price for the following reasons:

1/ Imetelstat has never been approved for anything
2/ Small biotech companies, with only one medicine, usually fail
3/ JNJ threw Imetelstat 'to the dogs' (not true)
4/ Management is corrupt (not true)
5/ Dilution

That said, the NDA will be accepted and will be approved by the FDA, the EMA and the MHRA (UK). The trials have been remarkable. Patients' needs are here and now.

[KTArsenal]

The market rewards profits and NOT potential.
The market absorbs your investment based solely upon potential/speculation. It is very rare that a speculative stock makes retail investors wealthy. Extremely rare.
When retail invests, Wall Street notices. They will hold your feet to the fire for as long as they can until they cannot any longer.
Shorting small cap equities makes millionaires billionaires.
Until Geron can admit that their NDA was accepted, hedgies are gonna bait the hook and toy with the bottom of the bay for as long as practical.
I believe they have until mid to late April to keep dragging the bait along the bottom to keep hooking those fat paychecks while hedging their institutional ownership.

[Ryan]

I agree with this, but for the timing. April? Who knows.

But the tlr data was / is knockout positive, and unimpeachable. No one refutes that, despite the constant obfuscation all over the place, including on this board now.

Pointing out that that quote above is directly from the quarterly report PR.

[LWS]

Shorting small cap equities makes millionaires billionaires.
Until Geron can admit that their NDA was accepted, hedgies are gonna bait the hook and toy with the bottom of the bay for as long as practical.
I believe they have until mid to late April to keep dragging the bait along the bottom to keep hooking those fat paychecks while hedging their institutional ownership. --- from KTArsenal

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The share price, the last time that I looked, was $2.38. That means that the "manipulators" are still in full control of Geron's PPS. I have my position, which I believe is fully supported by the science, trials and "remarkable successes". I will not wavier.

I believe that the NDA is summitted, under review and will soon be approved.

[KTArsenal]

An investment in a late-stage biotech is always a nail biter before the NDA. This isn't breaking news or a headline never read before. Retail investors are the incurable herpes sores upon the lips and nether regions of the greedy; and their greed will be the end to humankind, someday.

For now, GERN gives back gains to force retail to retreat while institutional investments are increasing.

Seems sketchy.

Hang in there.

[LWS]

I believe that the NDA is summitted, under review and will soon be approved.

It must be obvious to everyone that the Imetelstat NDA has to be accepted and approved by the FDA (and others) for Geron to continue as a viable company. A rejection of this NDA would mean that Imetelstat is a worthless medicine. Geron is a one-medicine company.

Considering the successes of Imetelstat to-date, I don't see how rejection is possible. Also, the staff (Kmall's specialty) and the manufacturing preparedness would not make any sense, unless Imetelstat was very good now as a single agent, with greater potential in combinations.

This is a strange, unpredictable world that we live in, so what seems obvious to me (NDA acceptances and approvals post-haste) may go down another path. I don't think so, but as someone said: FUDD (Fear, Uncertainty, Doubt, Deception).

[LWS]

This is a strange, unpredictable world that we live in, so what seems obvious to me (NDA acceptances and approvals post-haste) may go down another path. I don't think so, but as someone said: FUDD (Fear, Uncertainty, Doubt, Deception).

We have come down to a critical situation. The question becomes: Is Geron a viable company with an important, proven blood cancer medicine (Imetelstat, the franchise)?

My answer is yes, but my vote doesn't count.

The NDA has become the only item of importance, at this point in time. If the NDA is accepted and approved (fast-track & orphan status in place) then all is well. If the NDA is rejected, then Geron has no alternatives to Imetelstat, and is likely finished.

[LWS]

Considering the successes of Imetelstat to-date, I don't see how rejection is possible. Also, the staff (Kmall's specialty) and the manufacturing preparedness would not make any sense, unless Imetelstat was very good now as a single-agent, with greater potential in combinations.

The heavy lifting is done. I see no other 'shoes that can fall' to stop Imetelstat from being approved on several levels as a single-agent medicine, that is also suitable for off-label uses. The modular NDA is under review now, with patients' needs the #1 priority. The timeline for acceptance and approvals is always the question.

[LWS]

NDA has become the only item of importance, at this point in time. If the NDA is accepted and approved (fast-track & orphan status in place) then all is well. If the NDA is rejected, then Geron has no alternatives to Imetelstat, and is likely finished.

Imetelstat is the franchise. Geron = Imetelstat’s successes. The NDA review, acceptance and approval is ‘make it or break it’ for Geron.

[LWS]

As always, there is only one franchise (Imetelstat). What Geron is worth has to do with Imetelstat's medical successes, market forces, and what is in John Scarlett's head (Plans A (partners), B (buyout) and C (go it alone)). We all assume that the NDA will be accepted and approved, since all the trials were successful, the data was very good (remarkable says Geron) and patients' needs are great. We also don't know about JNJ's continuing interest, which seems substantial.

[LWS]

Considering the successes of Imetelstat to-date, I don't see how rejection is possible. Also, the staff (Kmall's specialty) and the manufacturing preparedness would not make any sense, unless Imetelstat was very good now as a single agent, with greater potential in combinations.

The other-side of the coin seems to be 'dilution' of Geron's stock with several points of view. It still isn't clear to me why this is being done. Suggestions have been made: reserve stock, poison pill, self-enrichment, poor judgement, long term considerations, etc. There has been a level of discomfort here. For better or worse, John Scarlett is in charge (Plan A (partners), Plan B (buyout), Plan C (go it alone)). Hopefully, the NDA will soon be accepted and approved, and JS will be revered for his wisdom.

[LWS]

NDA has become the only item of importance, at this point in time. If the NDA is accepted and approved (fast-track & orphan status in place) then all is well. If the NDA is rejected, then Geron has no alternatives to Imetelstat, and is likely finished.

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The NDA is everything now. I believe that its acceptance and approval is a done deal. Some have talked about the "miracle in May". Will May be the month where everything comes together for Geron, including fast-track approvals and a clear path to manufacturing and commercialization? Has Scarlett chosen his partners, or will there be partners? Where do JNJ and AbbVie fit into Imetelstat's future?

These are interesting times for Geron, associates, patients and investors.

[LWS]

Where do JNJ and AbbVie fit into Imetelstat's future?

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JNJ, one way or the other, was involved in the substantial increase in Geron's shares today. JNJ's continuing interest in blood cancer treatments, especially in Imetelstat, is well known. We do not know how JNJ will fit into Imetelstat's future, but it will be an important part of their future.

[LWS]

There seems to be two powerful forces at work today. In the morning there was the usual crew bringing Geron's PPS down considerably. In the afternoon another force became active, bringing the PPS above yesterday's close. This is now a tug of war. The closing price today will be closely followed.

I believe that the modular NDA is under review by the FDA (and perhaps others). This was confirmed in today's conference call. Final decisions are coming. Perhaps we are looking toward the "Miracle in May". The Imetelstat franchise is on the line, as well as Geron's future.

These are interesting times.

[FC4364]

GERON reported that as of 03/31/2023 it had over 400 million in financial resources on balance sheet that supports a launch uncompromised by financial constraints.

[huntingonthebluffs]

If you have or are considering a significant investment in Geron / Imetelstat and don't listen to the "entire" Needham fireside webcast it would be in MHO unfortunate. Dr. John Scarlet does a masterful job of covering all the pertinent bases in both defining and setting expectations. I hope all here will do themselves a favor and take the time.

https://wsw.com/webcast/needham129/gern/2250664