Upcoming Events....

[Hoosier Investor]

May 2nd -- Q1 Earnings Release (8:00am)

May 9th -- Shareholder Meeting

May 14th -- EHA Abstracts available online

May 15th -- Updated 13F filings due (Updated stats on our Institutional Investors)


I'm hoping for an EHA abstract on Lymphoma (pre-clinical) studies, but I'm not anticipating one. I suspect the EHA abstracts will be all about LR-MDS results similar to last year's ASH conference. This seems appropriate given our pending MAA in Europe.

The ongoing HR-MDS / AML study is an Investigator Sponsored Trial (IST) which means they (sponsors) can likely publish results if/when they desire (i.e. not likely to be constrained by Geron timing preferences and/or approvals). They've already leaked that we're likely to see good news (QIR Australia video), but the timing of further info is uncertain. Most likely, they will wait until they have formal topline numbers which I believe is going to be in 2025 (~12 months from now).

I'm planning to submit a couple of questions for the shareholder meeting. I will see if I can get a comment on IMET2.0, Lymphoma, and/or Ferroptosis. Each topic represents a forward-looking wildcard that could factor significantly into the company's future. The company's future looks bright already based on the likelihood of Imetelstat yielding net positive benefits involving the MDS, MF, and AML indications. We could realize significant incremental value should any of the three aforementioned wildcards play out favorably.

Best wishes to everyone....

[Ryan]

May 2nd -- Q1 Earnings Release (8:00am)

May 9th -- Shareholder Meeting

May 14th -- EHA Abstracts available online

May 15th -- Updated 13F filings due (Updated stats on our Institutional Investors)


I'm hoping for an EHA abstract on Lymphoma (pre-clinical) studies, but I'm not anticipating one. I suspect the EHA abstracts will be all about LR-MDS results similar to last year's ASH conference. This seems appropriate given our pending MAA in Europe.

The ongoing HR-MDS / AML study is an Investigator Sponsored Trial (IST) which means they (sponsors) can likely publish results if/when they desire (i.e. not likely to be constrained by Geron timing preferences and/or approvals). They've already leaked that we're likely to see good news (QIR Australia video), but the timing of further info is uncertain. Most likely, they will wait until they have formal topline numbers which I believe is going to be in 2025 (~12 months from now).

I'm planning to submit a couple of questions for the shareholder meeting. I will see if I can get a comment on IMET2.0, Lymphoma, and/or Ferroptosis. Each topic represents a forward-looking wildcard that could factor significantly into the company's future. The company's future looks bright already based on the likelihood of Imetelstat yielding net positive benefits involving the MDS, MF, and AML indications. We could realize significant incremental value should any of the three aforementioned wildcards play out favorably.

Best wishes to everyone....

Definitely of interest that the Quarterly Call and the Annual Shareholders Meeting are not smooshed together… seems Dr. Scarlett wants to talk. And for sure Dr. Feller going to get a curtain call, “speech!”.

[Hoosier Investor]

Apparently, I forgot one of the upcoming events when I put this list together yesterday. Not sure how I missed it, but here it is....

April 29 -- Analyst Upgrade to "Strong Buy" with $10 price target.


Q: Any guesses on what will be our new Institutional Ownership percentage come 5/15? Above 75%?

I recall a few years back, being envious of INCY's relative share price stability. A quick check showed an Institutional ownership percentage in the high 90% range (98% as I recall). It will be nice if we can achieve such a level one day.

[LWS]

There is too much here, once the FDA grants approval, for Geron to go it alone. I expect partners, collaborators, combinations and associates at several levels.

We all expect FDA approval after the 12 YES vote recommendation from ODAC. However, some potential investors are apparently taking a wait and see approach. We are all waiting for the fat lady (FDA) to sing. We will see what these "upcoming events" bring.

[LWS]

Quick Summary of Today's Remarks

=================
Path to Commercial Value Creation, Geron is well-positioned for a successful U.S. launch upon potential approval

• Commercial team fully onboarded with completion of hiring of the U.S. sales force in April 2024

• Enhanced capabilities and coordinated enterprise functions provide infrastructure for commercial excellence

• Commercial supply plans finalized

• Concentrated prescriber base identified

• Patient access and affordability solutions on target Imetelstat is highly differentiated in the TD LR-MDS market

• Opportunity for imetelstat given stakeholder dissatisfaction with available options in TD LR-MDS

• Enthusiasm for totality of clinical benefit with imetelstat, including durable RBC-TI, hemoglobin increases, reductions in transfusion burden, with generally wellcharacterized and manageable cytopenias Patent and market exclusivity in the U.S.

• Orphan drug exclusivity through 1H 2031

• Method of use patent for MDS and MF expires March 2033, with exclusivity expected into 2037 if patent term extension is applied.

[LWS]

More Information From May 2, 2024
=======================
Geron Corporation Reports First Quarter 2024 Financial Results and Business Highlights
May 02, 2024

June 16, 2024 PDUFA date for imetelstat NDA for the treatment of transfusion-dependent anemia in adult patients with lower-risk MDS

FOSTER CITY, Calif.--(BUSINESS WIRE)-- Geron Corporation (Nasdaq: GERN), a late-stage clinical biopharmaceutical company developing investigational first-in-class telomerase inhibitor, imetelstat, to treat hematologic malignancies, today reported financial results and business highlights for the first quarter 2024.

“Since the FDA ODAC’s 12 to 2 vote in favor of the clinical benefit/risk profile of imetelstat for the treatment of transfusion-dependent anemia in patients with lower-risk MDS in March, we have continued working with the FDA as they complete their review of our New Drug Application, which has a June 16, 2024 PDUFA target action date,” said John A. Scarlett, M.D., Chairman and Chief Executive Officer. “We are actively preparing for a successful launch of imetelstat in the U.S., if approved, including most recently onboarding our sales force last month, refining our market research and completing buildout of our enterprise capabilities and systems to support our transition from a clinical to commercial-stage company.”

U.S. Commercial Preparation

Geron has now completed onboarding its commercial team, with the buildout of the full sales organization in April. Other commercial preparations for the U.S. are ongoing and on target, including enhancing and/or establishing company processes and systems to support an expected commercial launch, refining market research in TD LR-MDS, and engaging in marketing, commercial access, payer, and reimbursement preparatory efforts.

Clinical Development Update

The Phase 3 IMpactMF clinical trial, which has a primary endpoint of overall survival, is ongoing in myelofibrosis patients who are relapsed/refractory to JAK inhibitors. Last month, the data monitoring committee evaluated unblinded data and recommended the clinical trial continue. In addition, the Company reviewed enrollment rates and blinded death rates, which are lower than anticipated based on initial planning assumptions. Accordingly, guidance is being updated to extend the timelines by half a year, with the interim analysis now expected in early 2026 and the final analysis expected in early 2027.

First Quarter 2024 Financial Results

As of March 31, 2024, the Company had approximately $465 million in cash and marketable securities, including proceeds from an underwritten public offering of common stock and a pre-funded warrant in March 2024 for net proceeds of approximately $141 million.

[pursang]

lws,
thanks so much for sussing out this valuable information, we'd be lost without you ..

[KTArsenal]

When LWS visits their favorite restaurant, their go-to order must be:

Overcooked copypasta and meatballs. Meatballs are extremely overdone and also not a lot of meat in the ingredients. Extra filler.

For dessert, it's gonna be warm (parenthetical) pie served with a scoop of vanilla. Not ice cream, just a scoop of vanilla.

[LWS]

In John Scarlett's own words:

Geron continues to work closely with the FDA. The NDA (New Drug Application) is under complete review and Geron is "preparing for a successful launch". I don't see any foul-ups, conspiracies or shenanigans at this point in time. Approval looks ensured, but it is not a perfect world that we live in.

=============
From John Scarlett

“Since the FDA ODAC’s 12 to 2 vote in favor of the clinical benefit/risk profile of imetelstat for the treatment of transfusion-dependent anemia in patients with lower-risk MDS in March, we have continued working with the FDA as they complete their review of our New Drug Application, which has a June 16, 2024 PDUFA target action date,” said John A. Scarlett, M.D., Chairman and Chief Executive Officer. “We are actively preparing for a successful launch of imetelstat in the U.S., if approved, including most recently onboarding our sales force last month, refining our market research and completing buildout of our enterprise capabilities and systems to support our transition from a clinical to commercial-stage company.”

[rccola335]

So the advisory board reviewed unblinded data and recommended continuation = seems to be working

Geron reviewed blinded data and people are living longer than expected so the interim analysis is extended - is this due to people on imetelstat living longer than expected or both groups living longer - the million dollar question (should I say billion) - life expectancy after discontinuation of JAK inhibitor was never certain - we heard 7-12 months - then 12-14

[LWS]

Tomorrow's (May 9) shareholder meeting may present more information for us to dissect. I don't see anything preventing Imetelstat's NDA approval, that is honest and above board. (No shenanigans or conspiracies that are credible)

Anything is possible in the world of Geron. However, as far as I can tell, an ODAC positive recommendation (12 YES, 2 NO) has NEVER been rejected by the FDA. This could be the 1st time. That seems highly unlikely at his late date.