PPS

Forum rules
- Comments must be civil and on topic
- Back up claims with evidence/reasoning/sources (posting links is allowed)
- No commercials/harassment/spam
LWS
Posts: 671
Joined: Thu Jul 14, 2016 2:00 am

Re: PPS

Post by LWS » Wed Jan 03, 2024 9:28 pm

New Prediction:

My prediction of $4.00 by Jan 1, 2024 was wrong. We still have not heard from the Oncology ADCOM (or ODAC), but know the NDA is under review. We also know that all medical and scientific data that has been collected and published is positive. In addition, the EAP is supplying additional data (can be considered a phase 4, according to JS -fireside chat).

My new timeline for $4.00 is now Valentine's Day (Feb. 14). I see only positive data and positive comments from KOLs.
=============
Previous (Oct. 2, 2023):


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

LWS
Posts: 671
Joined: Thu Jul 14, 2016 2:00 am

Re: PPS

Post by LWS » Sun Jan 28, 2024 6:46 pm

PPS to be Determined by NDA Approval by FDA

It has been suggested that, because of Imetelstat's huge potential in combinations, oral forms (aspirin like preventative), IMET2.0 (new formulations), EAP (ongoing) and NDA approval (coming soon), that Geron is in the driver's seat. Obviously, Geron's negotiating position will be vastly improved by ODAC endorsements, which insures FDA approval.

LWS
Posts: 671
Joined: Thu Jul 14, 2016 2:00 am

Re: PPS

Post by LWS » Mon Jan 29, 2024 7:15 pm

January 2024 -- From Geron

1/Geron is On Target for a Successful Transition to Commercial Company in 2024.
PDUFA date of June 16, 2024 for imetelstat in transfusion-dependent (TD) LR-MDS* MAA review completion expected by end-2024, with potential EU approval and launch in 2025.

2/Imetelstat Ph3 data showed unprecedented durability of transfusion independence (TI) across multiple MDS patient subgroups not addressed by currently available products.

3/Additional Ph3 trial of imetelstat ongoing in relapsed/refractory myelofibrosis (R/R MF) with an interim analysis expected first half of 2025.

4/Significant commercial opportunities with TD LR-MDS total addressable market (TAM) >$3.5B and R/R MF TAM >$3.5B in 2031 (U.S./EU).

Zhears
Posts: 75
Joined: Mon Oct 08, 2018 12:19 pm

Re: PPS

Post by Zhears » Mon Jan 29, 2024 9:43 pm

LWS, you may have more success in your goals, if you make repeat posts on other forums, Reddit, or Stocktwits.
Share the information with a wider, less informed audience.

KTArsenal
Posts: 116
Joined: Fri Jul 01, 2022 10:35 am

Re: PPS

Post by KTArsenal » Mon Jan 29, 2024 10:02 pm

I would like to 2nd this motion.

LWS
Posts: 671
Joined: Thu Jul 14, 2016 2:00 am

Re: PPS

Post by LWS » Tue Jan 30, 2024 1:55 am

Information Management and the Price Per Share

This is a chatroom. This thread has to do with the PPS of Geron, which is obviously tied to what the FDA's advisory committee (ODAC and their KOLs) is thinking. Everything looks good medically, as far as I can tell (trials, KOLs, publications, etc.), so I do not expect any surprises going forward on the medical side.

The people that need to be convinced, from a market point of view, are the investment banks such as Goldman Sachs and BofA/ML. It is hard to know who knows what at this point in time.

From a business point of view, John Scarlett is a controversial figure. In my opinion, this is all playing out now, behind the scenes. I believe that all (doctors, scientists, patients, investors, Geron staff) will all be pleased with the outcome. It has been a very long and bumpy road to get to where we are, without any "shenanigans" in the trials or the continuing EAP. We are talking about several more months for the NDA approval (or less, hopefully). Stay cool and have patients.

Zhears
Posts: 75
Joined: Mon Oct 08, 2018 12:19 pm

Re: PPS

Post by Zhears » Tue Jan 30, 2024 2:45 am

I think I messaged you once asking for a negative post. Basically to show the possible negatives had been evaluated in regards to the share price (minus the extreme which would make us all cry).

Time has ticked on since I sent that, so I would ask you to expand your view point beyond approval in june (really hope this is the case) basically pps focus for June date could be not quite the best focus. Isn't this a brief bounce before sales? My knowledge of the investment market is limited so I'm only going off my limited experience.

LWS
Posts: 671
Joined: Thu Jul 14, 2016 2:00 am

Re: PPS

Post by LWS » Wed Feb 14, 2024 7:15 pm

PPS to be Determined by ODAC (March 14th Meeting) Recommendation to FDA

There is little doubt now (none, as far as I am concerned) that the NDA for Imetelstat will be granted. My $4 PPS prediction by Valentines Day was premature. Goldman Sachs still has a "Buy" on Geron with a $4 price target. The Medical news for Imetelstat keeps getting better and better. This next 30 days will be very interesting and positive for Geron's PPS.

Happy Valentines Day

=================================================================
Previous (Jan. 28):

It has been suggested that, because of Imetelstat's huge potential in combinations, oral forms (aspirin like preventative), IMET2.0 (new formulations), EAP (ongoing) and NDA approval (coming soon), that Geron is in the driver's seat. Obviously, Geron's negotiating position will be vastly improved by ODAC endorsements, which insures FDA approval.

LWS
Posts: 671
Joined: Thu Jul 14, 2016 2:00 am

Re: PPS

Post by LWS » Fri Feb 16, 2024 6:55 pm

The PPS for Geron is a Mystery

As far as I can tell, from what I read, Imetelstat is medically proven to be a very good medicine for a variety of blood cancer conditions (alone, combinations, ongoing trials, etc.). Apparently, many large institutions are accumulating Geron's stock. There are no "shenanigans" medically that anyone knows about.

Normally, a company/medicine (Geron/Imetelstat) with so much proven, so much need, and so much potential would be much higher (PPS), at this point in time. March 14th (ODAC IMET Meeting) should right the ship. I see no medical negatives.

This is a story of hedge funds, naked shorts, and conspiracy theories that is not well understood now. The Imetelstat story is great material for a book on several levels including JNJ's continuing interest, AbbVie's combinations, MAIA, the FDA & EMA & MHRA, MF & MDS & AML, beyond (oral, new formulations, etc.).

I am very optimistic, but also prepared to be disappointed (such is life).

LWS
Posts: 671
Joined: Thu Jul 14, 2016 2:00 am

Re: PPS

Post by LWS » Fri Feb 23, 2024 10:27 pm


Press Release Details
Geron to Announce Fourth Quarter and Full-Year 2023 Financial Results on February 28, 2024


FOSTER CITY, Calif.--(BUSINESS WIRE)-- Geron Corporation (Nasdaq: GERN), a late-stage clinical biopharmaceutical company, announced that it will release its fourth quarter and full-year 2023 financial results and business highlights before the market opens on Wednesday, February 28, 2024 via press release, which will be available on the Company’s website at www.geron.com/investors. Geron will host a conference call to discuss the financial results as well as business highlights at 8:00 a.m. ET the same day.

A live webcast of the conference call and related presentation will be available on the Company’s website at www.geron.com/investors/events. An archive of the webcast will be available on the Company’s website for 30 days.

Participants may access the webcast by registering online using the following link, https://events.q4inc.com/attendee/964382933

LWS
Posts: 671
Joined: Thu Jul 14, 2016 2:00 am

Re: PPS

Post by LWS » Wed Feb 28, 2024 3:51 pm

I will try to listen to the Conference Call later today. Is there anything that is forward looking and encouraging (for those that listened live)?

lacour_98
Posts: 37
Joined: Thu Sep 07, 2023 6:57 pm

Re: PPS

Post by lacour_98 » Wed Feb 28, 2024 6:12 pm

I've quickly looked at the CC transcript and didn't see anything forward looking or encouraging that we didn't already know. Scarlet seemed guarded in his responses in the Q&A. I'll reread later. No update on EAP nor AML, High-Risk MDS trial. The trading activity jumped at the open and the SP jumped some + 20 cents, then fell back down.

LWS
Posts: 671
Joined: Thu Jul 14, 2016 2:00 am

Re: PPS

Post by LWS » Wed Feb 28, 2024 7:11 pm

Some comments from Feb. 28 to ponder. March 14 (ODAC meeting) is the next critical date.

==================================== 
Geron Corporation Reports Business Highlights and Fourth Quarter and Full Year 2023 Financial Results
February 28, 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 business highlights and financial results for the fourth quarter and full year 2023.

“Geron’s progress and execution throughout 2023 has paved the way for a potentially transformational 2024, as we plan for the transition to becoming a commercial company,” said John A. Scarlett, M.D., Chairman and Chief Executive Officer. “We believe that we are in a strong position for value creation, based on our differentiated product candidate, the potential for significant commercial opportunities in transfusion-dependent, lower-risk MDS and relapsed/refractory MF, the excellence and experience of our employees, and the strength of our balance sheet to support a potential U.S. launch.”

2023 Business Highlights

Transfusion-Dependent Lower-Risk Myelodysplastic Syndromes (TD LR-MDS)


In January 2023, Geron reported positive top-line results from the pivotal IMerge Phase 3 clinical trial evaluating imetelstat in patients with TD LR-MDS. Additional data including subgroup analyses and patient-reported outcomes were subsequently reported at the European Hematology Association Annual Meeting in June 2023 and at the American Society of Hematology Annual Meeting and published in The Lancet in December 2023.

In August 2023, the U.S. Food & Drug Administration (FDA) accepted the New Drug Application (NDA) for imetelstat for the treatment of TD anemia in adult patients with low- to intermediate-1 risk myelodysplastic syndromes, who have failed to respond, or have lost response to, or are ineligible for erythropoiesis-stimulating agents (ESAs). The FDA assigned a Prescription Drug User Fee Act (PDUFA) action date of June 16, 2024 to the NDA.

On January 30, 2024, the FDA provided notice in the Federal Register that it has scheduled a public Oncologic Drugs Advisory Committee to be held virtually on March 14, 2024, as part of the imetelstat NDA review.
In September 2023, the European Medicines Agency (EMA) validated the Marketing Authorization Application (MAA) for imetelstat in the same proposed indication as the NDA.


Myelofibrosis

In December 2023, Geron achieved fifty percent enrollment in the Phase 3 IMpactMF clinical trial investigating imetelstat versus best available therapy (BAT) in patients with intermediate-2 or high-risk Myelofibrosis (MF) who are relapsed/refractory myelofibrosis (R/R MF) to Janus kinase (JAK) inhibitor treatment.
In January 2024, dosing in the Phase 1 IMproveMF study evaluating imetelstat as a combination therapy with ruxolitinib in patients with intermediate-2 or high-risk MF (frontline MF) was escalated to the third of four doses following a decision by the study’s independent Safety Evaluation Team (SET).

Corporate


In November 2023, Geron appointed Gaurav Aggarwal, M.D., a prominent investor in the life sciences sector for more than two decades who has a history of expertise in financial and corporate strategy, as well as business development, to Geron’s Board of Directors.

In August and September 2023, respectively, Geron appointed Scott Samuels as Executive Vice President, Chief Legal Officer and Corporate Secretary, and Michelle Robertson as Executive Vice President, Chief Financial Officer and Treasurer. Both Mr. Samuels and Ms. Robertson join Geron with a track record of excellence in commercial-stage biopharmaceutical companies.

Anticipated Upcoming Milestones


U.S. commercial launch of imetelstat upon potential FDA approval (PDUFA date June 16, 2024) for the treatment of transfusion-dependent anemia in adult patients with LR-MDS who have failed to respond, or have lost response to, or are ineligible for ESAs.

Review of the imetelstat MAA for the same indication as the NDA expected to be completed in early 2025. Subject to approval by the European Commission, EU commercial launch of imetelstat could occur in 2025.
Interim analysis from the Phase 3 IMpactMF trial in R/R MF expected in the first half of 2025, with a final analysis from the study expected in the first half of 2026.

U.S. Commercial Preparation


Throughout 2023, Geron completed several long-lead time pre-commercial activities, including securing a global trademark for the imetelstat brand name; finalizing third party logistics, our distribution network, patient support providers; and onboarding highly experienced commercial and medical affairs teams. Other pre-commercial preparations for the U.S. are ongoing, including enhancing and/or establishing company processes and systems to support an expected commercial launch, refining our market research in TD LR-MDS, and engaging in marketing, commercial access, payer, and reimbursement preparatory efforts.

Ryan
Posts: 384
Joined: Sat Jul 08, 2017 1:41 pm

Re: PPS

Post by Ryan » Wed Feb 28, 2024 9:50 pm

Great call today. The excellence and experience of our personnel, thumbs up. Mentions of the Lancet. Question about the ODAC comment from the heme experts, nice one.

And of course the pps. Hence why I’m responding in this thread. Spike up and now way down. Looks like ~12 million will trade today. Pointing out that I called on ‘max pain’ for retail investors at the start of the year… if you didn’t know what that meant, take a deep breadth and let me know how it feels. And of course the nothing to see here vibes continues.

As confident as ever.

LWS
Posts: 671
Joined: Thu Jul 14, 2016 2:00 am

Re: PPS

Post by LWS » Thu Mar 07, 2024 5:55 pm

7 Days --The Oncology ADCOM meeting is one week from now (Imetelstat ODAC meeting--- March 14, 2024)

I believe that World 1 (Medical Successes & Scientific Breakthroughs for Imetelstat) will finally prevail, as the KOLs (in a public hearing) testify about patients' immediate needs, safety and uniqueness. The first goal (of many) is approval of NDA for Transfusion Independence. ODAC recommends and the FDA approves. That will lead to off label uses, new combinations, partners and (hopefully) a major uptick in the PPS.

=============
Previous (Oct. 2, 2023):

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
Posts: 384
Joined: Sat Jul 08, 2017 1:41 pm

Re: PPS

Post by Ryan » Sat Mar 09, 2024 12:41 am

Hopefully this is the start of something new, and up, for the PPS today, and not another, yet another, head fake. I mean the meeting is next week. :arrow:

LWS
Posts: 671
Joined: Thu Jul 14, 2016 2:00 am

Re: PPS

Post by LWS » Tue Mar 12, 2024 3:01 pm

Too many opinions now. Some are based upon science and medical trials. Others are based upon hearsay and fabrications. ODAC, we believe, will be fair and will not be swayed by special interests. The ball is certainly in their court, with little time on the clock. Tempers are becoming a bit too heated. ODAC's thoughts will soon be revealed. The FDA and how it functions are also in focus and on trial.

jayfish101
Posts: 150
Joined: Tue Feb 23, 2016 5:48 pm

Re: PPS

Post by jayfish101 » Tue Mar 12, 2024 3:03 pm

I am concerned about all the negativity and questioning manner of the comments in the ODAC agenda. Is this just boiler plate stuff or does it point to rejection or need for further study?

LWS
Posts: 671
Joined: Thu Jul 14, 2016 2:00 am

Re: PPS

Post by LWS » Mon Mar 18, 2024 6:20 pm

Even with the good news from ODAC, Geron's PPS is still under pressure. Some is profit taking. Other factors involve the computer algorithm, that appears to still be in control. I don't believe the importance of this transfusion independence decision (along with quality of life & survival time) is appreciated by the short-term investors. That will soon change.

LWS
Posts: 671
Joined: Thu Jul 14, 2016 2:00 am

Re: PPS

Post by LWS » Tue Mar 19, 2024 6:36 pm


Geron raises $150M as the PPS passes $3.25 after ODAC positive recommendation.

==============
Geron Corporation Announces Pricing of $150 Million Underwritten Offering of Common Stock and Pre-Funded Warrants
March 19, 2024


FOSTER CITY, Calif.--(BUSINESS WIRE)
-- Geron Corporation (Nasdaq: GERN), a late-stage clinical biopharmaceutical company, today announced the pricing of an underwritten offering consisting of 41,999,998 shares of its common stock at a price of $3.00 per share and pre-funded warrants to purchase 8,002,668 shares of its common stock. The pre-funded warrants are being sold at a price of $2.999 per pre-funded warrant. All of the securities in the offering are to be sold by Geron. The offering included participation from RA Capital Management, Fairmount, OrbiMed, Farallon Capital Management, Adage Capital Partners, L.P., Boxer Capital, Vivo Capital, Deep Track Capital, and multiple large investment management firms, in addition to other new and existing investors. The offering is expected to close on or about March 21, 2024, subject to the satisfaction of customary closing conditions.

The gross proceeds to Geron from this underwritten offering, before deducting the underwriting discount and other estimated offering expenses, are expected to be approximately $150.0 million. Geron currently intends to use the net proceeds from this offering, together with its existing cash, cash equivalents, and current and noncurrent marketable securities, to fund the potential commercialization of imetelstat in low or intermediate-1 risk myelodysplastic syndromes in the U.S, and potential launch and commercialization of imetelstat in low or intermediate-1 risk myelodysplastic syndromes in the EU, subject to receipt of regulatory approvals, as well as continued development and potential regulatory submissions for imetelstat in relapsed/refractory myelofibrosis. Geron intends to use the remaining proceeds, if any, for working capital and general corporate purposes.

TD Cowen, Stifel and Barclays are acting as joint book-running managers for the offering. Wedbush PacGrow is acting as co-manager for the offering.

Post Reply