It has always been amazing to me how well Geron's PPS can be held so well in a specific place (now at about $3) by the 'market-forces' (hedge funds, computer controls, deep pockets, naked shorts ????). The EAP is in place, and the modular NDA has now been fully summitted. All looks good medically, with partners likely in the wings.
We believe that the NDA will soon be accepted and approved. Until that happens, it looks like the 'market-forces' will be able to control the PPS, even though the reviews for Imetelstat are outstanding (KOLs, Webinars, etc.). I am hoping that some coming event will soon surprise us on the upside. John Scarlett has that knowledge and power to move the PPS much higher.
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
- Comments must be civil and on topic
- Back up claims with evidence/reasoning/sources (posting links is allowed)
- No commercials/harassment/spam
Re: PPS
That 0.02%
This being Geron, there is always some mystery and confusion about what is going to happen next. The probability of success (approval of the NDA) looks to be a done-deal (Ryan says 99.98%), with negligible possibility of some unanticipated catastrophe. However, the rest of the investment world (beyond this board), seem to be, for the most part, nonbelievers.
Goldman Sachs is closely following the progress of the NDA. The month of August will tell us about acceptance (and perhaps approval) of the NDA, which is (obviously) crucial to Geron's and Imetelstat's future. We can only deal with probabilities and possibilities looking forward. All looks good, but there is always an element of uncertainty looking into the future.
================================================
This being Geron, there is always some mystery and confusion about what is going to happen next. The probability of success (approval of the NDA) looks to be a done-deal (Ryan says 99.98%), with negligible possibility of some unanticipated catastrophe. However, the rest of the investment world (beyond this board), seem to be, for the most part, nonbelievers.
Goldman Sachs is closely following the progress of the NDA. The month of August will tell us about acceptance (and perhaps approval) of the NDA, which is (obviously) crucial to Geron's and Imetelstat's future. We can only deal with probabilities and possibilities looking forward. All looks good, but there is always an element of uncertainty looking into the future.
================================================
We believe that the NDA will soon be accepted and approved. Until that happens, it looks like the 'market-forces' will be able to control the PPS, even though the reviews for Imetelstat are outstanding (KOLs, Webinars, etc.). I am hoping that some coming event will soon surprise us on the upside. John Scarlett has that knowledge and power to move the PPS much higher.
-
biopearl123
- Posts: 1670
- Joined: Fri Jul 20, 2018 5:13 pm
Re: PPS
RC, Dr. S suggested looking at Luspatercept sales. Once you do multiply by 3 and that’s conservative
Re: PPS
Bp - $1.5B sounds like a good place to start. -Kmall
https://www.fiercepharma.com/pharma/mer ... anemia-nod
https://www.fiercepharma.com/pharma/mer ... anemia-nod
-
biopearl123
- Posts: 1670
- Joined: Fri Jul 20, 2018 5:13 pm
Re: PPS
Kmall, agree, not an unreasonable number.
Re: PPS
With the EAP (extended & compassionate use) recently put in place, there is very little doubt (none, IMO) that the summitted NDA will be accepted and approved in a timely manner (fast-track & patients' immediate needs).
As an investor, I am extremely interested in new projects such as Oral Imetelstat, combinations in blood cancers-- especially AML & TELOMERE, and possible off-label uses for a variety of telomerase type cancers (about 90% of all cancers).
======================================
Previous:
Goldman Sachs is closely following the progress of the NDA. The month of August will tell us about acceptance (and perhaps approval) of the NDA, which is (obviously) crucial to Geron's and Imetelstat's future. We can only deal with probabilities and possibilities looking forward. All looks good, but there is always an element of uncertainty looking into the future.
Re: PPS
Geron to Announce Second Quarter 2023 Financial Results on August 3, 2023
Published July 27, 2023 04:30 PM Eastern Time
Business Wire
FOSTER CITY, Calif.--(BUSINESS WIRE)-- Geron Corporation (Nasdaq: GERN), a late-stage clinical biopharmaceutical company, today announced that it will release its second quarter 2023 financial results on Thursday, August 3, 2023 at 4:00 p.m. Eastern Time 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 4:30 p.m. Eastern Time the same day.
Published July 27, 2023 04:30 PM Eastern Time
Business Wire
FOSTER CITY, Calif.--(BUSINESS WIRE)-- Geron Corporation (Nasdaq: GERN), a late-stage clinical biopharmaceutical company, today announced that it will release its second quarter 2023 financial results on Thursday, August 3, 2023 at 4:00 p.m. Eastern Time 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 4:30 p.m. Eastern Time the same day.
Re: PPS
Some Aug. 3 Highlights:
FOSTER CITY, Calif.--(BUSINESS WIRE)-- Geron Corporation (Nasdaq: GERN), a late-stage clinical biopharmaceutical company developing a first-in-class telomerase inhibitor, imetelstat, to treat hematologic malignancies, today reported business highlights and financial results for the second quarter of 2023.
“We progressed our business significantly this quarter, as we evolve into a commercial company. Most notably, we submitted the first New Drug Application to the FDA for a telomerase inhibitor, a pioneering achievement that reflects our teams’ dedication to ground-breaking and innovative drug development,” said John A. Scarlett, M.D., Chairman and Chief Executive Officer. “Importantly, new data and analyses from IMerge Phase 3 presented at ASCO and EHA further strengthen the value proposition of imetelstat by highlighting differentiated attributes of the drug, such as unprecedented continuous durable transfusion independence, responses across subgroups, patient-reported outcomes of improved fatigue and strong evidence of disease-modifying activity.”
Dr. Scarlett also noted, “With approximately $400 million on the balance sheet as of the end of the quarter, we have the financial resources to not only fund a potential successful launch, but also to support the first year of launch.”
Business Highlights
Submitted New Drug Application (NDA) to the FDA based on results from IMerge Phase 3 in lower risk myelodysplastic syndromes (MDS).
Presented new data and analyses from IMerge Phase 3 at ASCO and EHA reporting robust durability of transfusion independence, evidence of disease-modifying activity and favorable fatigue patient-reported outcomes in imetelstat-treated lower risk MDS patients versus placebo.
Initiated Expanded Access Protocol (EAP) in June 2023, making imetelstat available to clinicians and patients prior to potential FDA approval.
Achieved >40% enrollment in IMpactMF, Geron’s Phase 3 trial of imetelstat in patients with myelofibrosis (MF) relapsed/refractory to JAK-inhibitors. Based on projected planning assumptions for enrollment and death rates in the trial, interim analysis is expected in the first half of 2025 and final analysis is expected in the first half of 2026.
Dosed first patient in June 2023 in the investigator-led Phase 2 IMpress trial, evaluating imetelstat in patients with relapsed/refractory acute myeloid leukemia or higher risk MDS.
Obtained and reported significant market research insights highlighting a potentially substantial commercial opportunity for imetelstat in lower risk MDS.
Appointed Scott Samuels as Executive Vice President, Chief Legal Officer and Corporate Secretary, following Stephen Rosenfield’s retirement at the end of July 2023. Mr. Samuels recently served as the General Counsel of BeiGene, Ltd., where he built a large, global legal and compliance team, oversaw launches of three internally developed drug products in the U.S., Europe and China and development of a global healthcare compliance program, and led key strategic transactions with Amgen Inc., Novartis AG and Celgene Corporation (now Bristol Myers Squibb Inc.).
FOSTER CITY, Calif.--(BUSINESS WIRE)-- Geron Corporation (Nasdaq: GERN), a late-stage clinical biopharmaceutical company developing a first-in-class telomerase inhibitor, imetelstat, to treat hematologic malignancies, today reported business highlights and financial results for the second quarter of 2023.
“We progressed our business significantly this quarter, as we evolve into a commercial company. Most notably, we submitted the first New Drug Application to the FDA for a telomerase inhibitor, a pioneering achievement that reflects our teams’ dedication to ground-breaking and innovative drug development,” said John A. Scarlett, M.D., Chairman and Chief Executive Officer. “Importantly, new data and analyses from IMerge Phase 3 presented at ASCO and EHA further strengthen the value proposition of imetelstat by highlighting differentiated attributes of the drug, such as unprecedented continuous durable transfusion independence, responses across subgroups, patient-reported outcomes of improved fatigue and strong evidence of disease-modifying activity.”
Dr. Scarlett also noted, “With approximately $400 million on the balance sheet as of the end of the quarter, we have the financial resources to not only fund a potential successful launch, but also to support the first year of launch.”
Business Highlights
Submitted New Drug Application (NDA) to the FDA based on results from IMerge Phase 3 in lower risk myelodysplastic syndromes (MDS).
Presented new data and analyses from IMerge Phase 3 at ASCO and EHA reporting robust durability of transfusion independence, evidence of disease-modifying activity and favorable fatigue patient-reported outcomes in imetelstat-treated lower risk MDS patients versus placebo.
Initiated Expanded Access Protocol (EAP) in June 2023, making imetelstat available to clinicians and patients prior to potential FDA approval.
Achieved >40% enrollment in IMpactMF, Geron’s Phase 3 trial of imetelstat in patients with myelofibrosis (MF) relapsed/refractory to JAK-inhibitors. Based on projected planning assumptions for enrollment and death rates in the trial, interim analysis is expected in the first half of 2025 and final analysis is expected in the first half of 2026.
Dosed first patient in June 2023 in the investigator-led Phase 2 IMpress trial, evaluating imetelstat in patients with relapsed/refractory acute myeloid leukemia or higher risk MDS.
Obtained and reported significant market research insights highlighting a potentially substantial commercial opportunity for imetelstat in lower risk MDS.
Appointed Scott Samuels as Executive Vice President, Chief Legal Officer and Corporate Secretary, following Stephen Rosenfield’s retirement at the end of July 2023. Mr. Samuels recently served as the General Counsel of BeiGene, Ltd., where he built a large, global legal and compliance team, oversaw launches of three internally developed drug products in the U.S., Europe and China and development of a global healthcare compliance program, and led key strategic transactions with Amgen Inc., Novartis AG and Celgene Corporation (now Bristol Myers Squibb Inc.).
Re: PPS
Geron's PPS will soar soon, based upon the science and the trials. This is the waiting period, while the FDA gets it all together. The EAP (extended and compassionate care) was most welcomed by patients' looking for new hope.
Geron has Imetelstat with excellent phase 3 trials, a good safety record, disease modification, transfusion improvements, much better survival time, observed CRs and PRs, and unmet patients' needs. The NDA has been summitted, and soon will be accepted and approved. The PPS will soon be in double digits.
Note: At 1PM on Aug. 4 (EST), Geron's PPS is at $3.00 again. There are many 'Imetelstat nonbelievers' in the investment world. It seems that only a NDA approval will convince them of Imetelstat's true worth now and potential going forward.
================================================
From Dr. Scarlett:
Geron has Imetelstat with excellent phase 3 trials, a good safety record, disease modification, transfusion improvements, much better survival time, observed CRs and PRs, and unmet patients' needs. The NDA has been summitted, and soon will be accepted and approved. The PPS will soon be in double digits.
Note: At 1PM on Aug. 4 (EST), Geron's PPS is at $3.00 again. There are many 'Imetelstat nonbelievers' in the investment world. It seems that only a NDA approval will convince them of Imetelstat's true worth now and potential going forward.
================================================
From Dr. Scarlett:
”“We progressed our business significantly this quarter, as we evolve into a commercial company. Most notably, we submitted the first New Drug Application to the FDA for a telomerase inhibitor, a pioneering achievement that reflects our teams’ dedication to ground-breaking and innovative drug development,” said John A. Scarlett, M.D., Chairman and Chief Executive Officer. “Importantly, new data and analyses from IMerge Phase 3 presented at ASCO and EHA further strengthen the value proposition of imetelstat by highlighting differentiated attributes of the drug, such as unprecedented continuous durable transfusion independence, responses across subgroups, patient-reported outcomes of improved fatigue and strong evidence of disease-modifying activity.”
Dr. Scarlett also noted, “With approximately $400 million on the balance sheet as of the end of the quarter, we have the financial resources to not only fund a potential successful launch, but also to support the first year of launch.
Re: PPS
Tantamount to approval (EAP)
The EAP (Extended Access and compassionate care) is tantamount to approval and bridges the gap before formal approval. Imetelstat is being used now around the world and has been informally approved. We are waiting for the paperwork to get completed before any formal announcement.
This appears to be a done deal.
The EAP (Extended Access and compassionate care) is tantamount to approval and bridges the gap before formal approval. Imetelstat is being used now around the world and has been informally approved. We are waiting for the paperwork to get completed before any formal announcement.
This appears to be a done deal.
Re: PPS
"Tantamount to approval (EAP)
The EAP (Extended Access and compassionate care) is tantamount to approval and bridges the gap before formal approval. Imetelstat is being used now around the world and has been informally approved. We are waiting for the paperwork to get completed before any formal announcement.
This appears to be a done deal."
We have made that assumption before, and I really wish you hadn't said that..
The EAP (Extended Access and compassionate care) is tantamount to approval and bridges the gap before formal approval. Imetelstat is being used now around the world and has been informally approved. We are waiting for the paperwork to get completed before any formal announcement.
This appears to be a done deal."
We have made that assumption before, and I really wish you hadn't said that..
Re: PPS
========================================================From Zhears --- I wish you had not said that
Back to the future: I think you are referring to Mayo Clinic's famous words ("Tantamount to a cure"). A Complete Response (CR) can look very much like a cure, and in some cases may be considered a cure (if there is no remission).
"Tantamount to" are words that can have meanings with various shades of gray: equivalent to, similar to, etc. In this case, we should revisit those original words with the medical knowledge that we now have today. Dr. Tefferi is very important in 'The Imetelstat Story".
======================================================
Previous thoughts for review:
Mayo Clinic (Tantamount to a cure)
JS (Bigger than all of us) (Tantamount to a cure)
Dr. Rizo (Remarkable and compelling)
MD Anderson (Numerous positive remarks)
Re: PPS
Hi,
I was actually thinking of just before JnJ walked and there was the announcement/leak of compassionate use then. I remember saying to friends it must be a shoe in for approval then. It's been a long wait since then.
I think there is the risk that we are a little blinkered view of approval and the share price. Approval is just an important step along the road to eventual profits(cold hearted view of it). Between then and now there is the question of marketing and in the last CC they mentioned hiring another 130 people and sales people aren't cheap. 400 million in the bank won't last that long with doubling the workforce, paying for perks for doctors golf weekend etc.
That and paying for more trials. means there is still a high likely hood of dilution.
Of course I hope I am wrong and the fact that they haven't hired sales people yet suggests buy out talks maybe going on.
I was actually thinking of just before JnJ walked and there was the announcement/leak of compassionate use then. I remember saying to friends it must be a shoe in for approval then. It's been a long wait since then.
I think there is the risk that we are a little blinkered view of approval and the share price. Approval is just an important step along the road to eventual profits(cold hearted view of it). Between then and now there is the question of marketing and in the last CC they mentioned hiring another 130 people and sales people aren't cheap. 400 million in the bank won't last that long with doubling the workforce, paying for perks for doctors golf weekend etc.
That and paying for more trials. means there is still a high likely hood of dilution.
Of course I hope I am wrong and the fact that they haven't hired sales people yet suggests buy out talks maybe going on.
Re: PPS
[
I suspect that Geron is having conversations with JNJ and AbbVIe (long term relations and deep pockets), especially about AML and various combinations going forward. Talks are most likely going on. I believe that the outcome will be strong partnerships and not a buyout. In either case, Geron is in a strong position, with an important blood cancer medicine, unmet patients' needs, EAP and a submitted NDA.
================================================================From Zhears---That and paying for more trials. means there is still a high likely hood of dilution.
Of course I hope I am wrong and the fact that they haven't hired sales people yet suggests buy out talks maybe going on.
I suspect that Geron is having conversations with JNJ and AbbVIe (long term relations and deep pockets), especially about AML and various combinations going forward. Talks are most likely going on. I believe that the outcome will be strong partnerships and not a buyout. In either case, Geron is in a strong position, with an important blood cancer medicine, unmet patients' needs, EAP and a submitted NDA.
Re: PPS
Zhears - good points on spending and dilution. They unfortunately go hand in hand. This company is certainly spending as if it's a Big Pharma. Don't forget about the "feel good" retreats for employees and numerous subcontractors hired in order to fulfill Clinical Trial patient enrollment. All of these things weigh on a company's bottom line. Being an outsider it's easy to criticize, but it appears from an investor standpoint that there is a bit of complacency regarding a financial spigot which is frozen wide open, with no relief in sight. Is this a case of total disregard for investors, or just ineptness in the planning process of Clinical Trial Designs and/or complete lack of financial oversight? My opinion is it's a combination of the two..... again I'm an outsider, easy to pick at while pointing a finger....maybe even the middle one! However, Dr. Scarlett did mention "not pinching pennies" with regards to getting an FIC drug like Imetelstat through both P3 Clinical Trials and the approval process shortly afterwards, and finally across the finish line back at Needham 2019. It certainly feels like he has taken this "not pinching pennies" approach to extremes. With that said it's always been my stance that only a Big Pharma can fully realize and maximize Imetelstats full potential with regards to revenue stream. Geron needs way too much cash to do so. Let's all hope as investors that Big Pharma is interested. If not we're going to be stuck in this never ending mire for a lot longer than most of us want or were expecting. -Kmall
Re: PPS
=============================================================With that said it's always been my stance that only a Big Pharma can fully realize and maximize Imetelstats full potential with regards to revenue stream. Geron needs way too much cash to do so. Let's all hope as investors that Big Pharma is interested. If not we're going to be stuck in this never ending mire for a lot longer than most of us want or were expecting. -Kmall
I agree that "Big Pharma" will be involved. Companies like JNJ and AbbVie (with their very deep pockets) have all the resources that Geron needs going forward for research, development, manufacturing, sales, distribution, etc.
We don't know what we don't know. Imetelstat is now a proven medicine, with EAP status and a summitted NDA pending approval. What could go wrong?
John Scarlett has always been controversial. That will continue.
Re: PPS
The subject for today : Great news, but a collapsing PPS. This is very difficult to understand.
What will the closing price look like today? The investment world is a very different world than that of science and medical breakthroughs.
======================
August 21, 2023
“FDA acceptance of our NDA is a significant milestone for both Geron and the MDS community, as there remain few treatment options and significant unmet needs, particularly for patients with difficult-to-treat subtypes of this cancer,” said Faye Feller, M.D., Executive Vice President, Geron’s Chief Medical Officer. “We believe that the IMerge Phase 3 data reflect the truly unique attributes of imetelstat, and, if approved, we expect imetelstat will change the standard of care in lower risk MDS.”
As allowed under the 21st Century Cures Act, the FDA has up to 74 days from the NDA submission date to notify Geron of the Prescription Drug User Fee Act (PDUFA) action date for the NDA. Upon receipt of this notification, Geron plans to disclose the timeline for the NDA review.
Additionally, Geron expects to submit a Marketing Authorization Application (MAA) in the European Union (EU) in the fourth quarter of 2023.