A couple of observations

[biopearl123]

1. For those who insist the NDA has not been submitted, you are only partially right. The NDA is being submitted in chunks, each module so far seems to be regarded favorably. It is unusual for a company to talk about submission status rather than acceptance, after all what company wants its shareholders to know it submitted if the subsequent event is rejection? Based on this I think is is safe to say the modules that have been submitted have already been accepted but the NDA has not been accepted in its totality, but this is how rolling submissions work, full submission has just not been reached. Rolling evaluation of this type saves lots of time. No bad news here. 2. The revelation by Faye in response to a particularly good question from an analyst, that data regarding patient driven events will be submitted for future publication is paramount. It's the money shot. First off, bad data does not get submitted for publication. For good data, its neon lights. Data that could show patient's symptoms improve and this improvement is linked to disease modification will be an important driver--the medicine makes you get better and feel better (and live longer?) 3. Anil is getting no significant pushback as he makes the value proposition case to payers. 4. Studies continue to move at a glacial pace but we will have Rux/Imetelstat data "in 2023", read Dec ASH, for 2/3 study site enrolling, that's pretty good. 5. No explanation for AML delays, why are your timelines never accurate, don't worry be happy. 6. Plenty of money. 7. Update on oral agent development this year. 8. Enrollment in MF study is slow and we have not reached 50% but we are trying and adding enrollment incentives (Amazon gift cards?). 9. Lymphoma development is alive and well. 10.Patience is a virtue. 11. All good things come to he who waits (Confucius). Best Wishes to all and welcome back Aron! bp

[kmall]

Bp- Thank you for your updates on the latest call. For those of you, like myself, who weren't able to listen in, here's a link of the transcript:

https://www.fool.com/earnings/call-tran ... ranscript/

From what I read, while generally positive with regards to data, I found the current cash burn and drawn out process from Regulatory Agencies concerning. I do understand the reasoning behind being cautious with regards to the safety of patients, however, the patients Imetelstat is targeting have very limited options. I'm definitely not understanding the point of Fast Track Designation by the FDA here? There doesn't seem to be anything "fast" about it. It's been well over 3yrs (9/30/2019) since that designation was granted by the FDA for MF.

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

As far as the cash burn is concerned, I can see now why a public offering was necessary back in January of this year. Holy smokes.....is putting it lightly. We were told by this company only two months before (11/4/2022), that they had sufficient funding to last until the "middle" of 2024:

"Under current planning assumptions, we expect to have approximately $140 million in cash and marketable securities at the time of the lower-risk MDS top-line results in early 2023. We also expect to have up to $171 million in additional funding available to us in 2023, which is comprised of approximately $121 million from potential exercises of currently outstanding warrants and an additional $50 million from potential debt drawdown under our current loan agreement upon the achievement of certain milestones and capital requirements. Under current planning assumptions, we project our existing capital resources plus the projected future proceeds that I just outlined will be sufficient to fund our estimated levels of operations, which includes stage-gated activity for potential U.S. commercial launch of imetelstat in lower-risk MDS until the middle of 2024" - Olivia Bloom (11/4/2022)

https://www.fool.com/earnings/call-tran ... ranscript/

I'm not in any way a mathematician or accountant, but they would be hard pressed to make it to the end of this year, let alone mid 2024 at the rate they're going through funding.

Speaking of funding, Geron is now "subcontracting" with several companies/organizations to initiate, recruit patients and provide clinical trial services:

Medialis in the UK - IMerge (MDS)
TMAC - The Medical Affairs Company - IMpact (MF)
GCP-Service International West GmbH - IMpress (AML)
MD Anderson - (Lymphoid Malignancies)

Each one of the above mentioned is additional "payroll" for Geron.

By the time Imetelstat reaches commercialization it will most likely be the costliest drug EVER, in the history of pharmaceuticals to develop. This company has spent well over $1B on their own.....and growing, not to mention what JNJ forked over for four years.

The only "real" "new" positive from this call was Anil Kapur's insight on payers and value proposition of Imetelstat in the future:

"So, the question around the payer feedback is extremely positive. I think the drugs that continue to come up are, obviously, Reblozyl, Inqovi within the lower-risk MDS landscape. But entire discussions are focused on our value proposition, both the efficacy profile, the totality of benefit, and what it would mean for the payers within their value proposition.

So, as of right now, these discussions are extremely favorable, and this data is being received well." -Anil Kapur

My take: Insurance companies are looking forward to savings......blood transfusions are costly.

Apologies for being a bit of a cynic here, but as another poster on the YMB pointed out.....broken record.

Thanks Hunter on the YMB for pointing out the oral agent and "Partnership" particulars - I've since edited the end of this post to reflect my negligence in catching either. Admittedly, I started skimming through a good portion of the transcript as it felt similar to the last. I do however have a valid reason for concern that another round of funding rears its head before any commercial launch ignition. -Kmall

[biopearl123]

445M in the bank (well, not that bank,) has got to get them to approval and income. Or partnership.

[kmall]

Bp- forgive me for playing Devil's advocate here, but I believe the $445M Olivia Bloom referenced is/was already in use....I understand that future tranche loan payments and warrants are down the road.....as she referenced in her runway extension expression, however, accumulated sounds past tense:

"As a result, we accumulated total cash holdings in excess of $445 million."

They're burning through a lot of coin at the moment. I'd be shocked if we don't see more dilution before ignition. Rough estimate, off the top of my head is $12-$15M/month, and most likely higher, in the $15-$18M range. A partnership would certainly stop the hemorrhaging. Certainly hope I'm wrong on this one. -Kmall

[Gwikley]

There seems to be a misconception by (apparently) a large % of small retail investors that the NDA back and forth with the FDA was completed and the wait time was "over". I'll admit to being one of those folks. I had been running on the assumption that the final approval was just weeks or months away. Wrong on all counts.
Going to the company website it is made quite clear that all of the MAJOR events will/should be taking place in '24.
Disappointing, for sure. But at least now I know what to/what not to expect. Reality check. lol

[LWS]

Going to the company website it is made quite clear that all of the MAJOR events will/should be taking place in '24.
Disappointing, for sure. But at least now I know what to/what not to expect. Reality check. --- from Gwikley

I believe that you are being unduly pessimistic, considering that cash is king now and Geron has about $450 million in reserve and an NDA (in modular form) likely completed and (at least) partially submitted with fast-track in place. In addition, JNJ and AbbVie are very much in the picture with very deep pockets, if needed. JS and some of his questionable tactics now look much better considering the banking crisis (SVB & others).

Everyone knows that Imetelstat must get approved to move ahead, meet patients needs, stop manipulations and get investors full confidence now.

Geron is in a very strong financial situation and a very strong negotiating position with a proven blood cancer medicine that has great potential in all telomere/telomerase type cancers.

[Ryan]

445M in the bank (well, not that bank,) has got to get them to approval and income. Or partnership.

Indeed to this.

Undeed on the Amazon gift cards, ha!
I suspect that Geron is going further then free experimental treatment, to include additional payouts perhaps for incidental costs for treatment (travel, lodging,,, callback on good old Irish who lamented the costs of traveling with her husband to I believe it was the Mayo Clinic in MN, and how they did affect their treatment decisions).