ImetelChat

Just a quick reminder that vibes are all to the good for Geron and Imetelstat / Rytelo.

I’m sure than sure we are in the “always darkest right before the dawn phase” for the company. Biotech in general is out of favor because, politics… I am not turning this into a political post (please don’t twist this into an oppo to start spouting your political views on this apolitical board… but really do whatever you want, just face the wrath of you do) BUT, National policy is moving to lower margins for biopharmas. Just stating the obvious.

With that, Geron is in the wash with that turbulence, but clearly (IMO) once the initial revenues start coming forth, and definitely after the second Q revenues show sequential QoQ growth, it will rise above that fray. The company is still valued as a non-revenue concern, and that will change.

For more info, don’t take it from me but peruse through the hundreds of excellent posts on this board about the value and necessity of Imetelstat / Rytelo.
This message brought to you by clarity.

i suspect with the EMA release that came out the 81 million shorts have started exiting and that's why the price was driven down - they knew they had a few months to make hay - ASH abstracts will be released Nov 5 and the corporate quarterly presentation is morning of Nov 7th (a morning presentation usually means no negative news) - wonder if we will see an update on the MF OS study presentation at ASH (could also come under the late breaking abstracts) like what mentioned as a possibility from MD Anderson and Mascarenas at Icahn.

Thanks - OK, but tangentially why would shorts exiting cause the pps to go down? Quite the opposite should be true if a unbalanced number of shorts were buying back stock to cover their short sale.

the push the share price to cover and yes they can manipulate the price

Oh OK, I see your logic but don’t necessarily believe that, but don’t have any inside knowledge so wouldn’t know definitively.

I would consider this a "good vibe"

Oct. 15, 2024 --- Abdulraheem Yacoub, MD, professor of Hematologic Malignancies and Cellular Therapeutics at the University of Kansas Medical Center, discusses imetelstat (Rytelo) as a newer and exciting option for patients with myelodysplastic syndromes (MDS).

In low- and intermediate-1 risk MDS and transfusion-dependent anemia, Yacoub says imetelstat offers a significant improvement in a population with limited effective treatments. The use of this drug can delay the need for hypomethylating agents and chemotherapy to later lines of treatment.

Use of imetelstat is also being investigated in trials for other blood cancers such as acute myeloid leukemia, myelofibrosis, and juvenile myelomonocytic leukemia. According to Yacoub, the development of imetelstat is a significant achievement in the oncology community and a major advancement for patients with MDS.

Most definitely - now that Rytelo is approved, it’s good to see more experts discussing and passing on information within the medical community.

Sure wish the SP had some good vibes.

Most definitely.
The spirit of my post was for some good vibes *in the face of the pathetic pps (the past 4 months - past year, still looks pretty good).
And my roundabout point was/is that this quarter’s report should look pretty good… but ultimately the next one w the QoQ comp is where this will really prove out to be a great place to be with an investment.

Another "good vibe" from another direction (Geron as an investment-- hedge funds, penny stocks )
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Is Geron Corporation (GERN) the Hottest Penny Stock to Invest in According to Hedge Funds?

Noor Ul Ain Rehman (Oct . 16, 2024)


Will Small Caps Rally in the Coming Days?

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Geron Corporation (NASDAQ:GERN)
Share Price: $4.31
Year to Date Performance: 104.27%
Number of Hedge Fund Holders: 26

Geron (NASDAQ:GERN) is a late-stage clinical biopharmaceutical company that develops and commercializes therapeutic products for myeloid hematologic malignancies. It is developing imetelstat, an investigational first-in-class telomerase inhibitor.

It is in Phase 3 clinical trials, and inhibits the uncontrolled proliferation of malignant stem and progenitor cells in myeloid hematologic malignancies. This treats low or intermediate-1 risk myelodysplastic syndromes and intermediate-2 or high-risk myelofibrosis. The company’s lead indication for imetelstat is in Low or Intermediate-1 risk myelodysplastic syndromes.

The company recently attained FDA approval for RYTELO, which is its branded name for imetelstat. RYTELO is the first and only telomerase commercially available in the US. The efficient mobilization of its team and strong commercial infrastructure at launch have brought about encouraging early launch results for the product.
This positive response in the hematology community highlights the unmet needs for lower-risk MDS patients with symptomatic transfusion-dependent anemia. Since a number of its customers are pushing to gain access to RYTELO, the company is seeing strong market inclinations to add the product to treatment pathways, formularies, and EMRs, along with community settings.

In addition, RYTELO gained the position of a Category 1 and 2A treatment for lower-risk MDS patients after the MDS NCCN Guidelines were updated on July 25. That gives RYTELO approval for use in both RS negative and RS positive first-line ESA ineligible patients and in both RS positive and RS negative second-line patients. This stands regardless of prior first-line treatment. The NCCN Guidelines have proved favorable for the product, putting RYTELO in a strong competitive position.

Geron’s (NASDAQ:GERN) distribution network and specialty distributor networks are fully activated to support customer demand across community oncology clinics and hospitals. RYTELO is available to HCPs across the 48 contiguous states within 24 to 48 hours through the company’s specialty distribution networks. The company ranks fourth on our list of the top hot penny stocks to invest in according to hedge funds.

I have been wondering for a while now if the EMA requires a supplier to be stipulated as part of the application process and if this would impact any possible buyout timeline.

As a good vibe point it seems that chatgpt doesn't think so.

Does the EMA need to have resellers stipulated for approval

ChatGPT
No, the European Medicines Agency (EMA) does not require companies to stipulate resellers (also referred to as distributors or wholesalers) during the drug approval process. The EMA focuses primarily on the safety, quality, and efficacy of medicines, particularly in relation to their development, manufacturing, and supply chain. Here's a breakdown of the distinctions:

1. Focus on Manufacturers and Suppliers
The EMA requires detailed information about the manufacturing sites, including the suppliers of active ingredients and the facilities responsible for the final production stages (formulation, packaging, etc.).
This information ensures that the medicine is manufactured according to Good Manufacturing Practice (GMP) standards and is consistent in quality.
2. Role of Resellers/Distributors
Resellers or distributors, who are involved in the distribution and sale of the medicine after it has been manufactured, are generally regulated at the national level by national competent authorities (NCAs) in each EU member state.
Once the EMA grants marketing authorisation, the marketing authorisation holder (MAH) can distribute the medicine within the EU. The MAH is typically responsible for managing the supply chain and distribution network, including choosing resellers.
3. Wholesale Distribution Authorisation (WDA)
Resellers and wholesalers who distribute medicines within the EU must comply with Good Distribution Practice (GDP) standards, which ensure that medicines are properly handled, stored, and transported.
However, obtaining a Wholesale Distribution Authorisation (WDA) is done at the national level, not by the EMA. Each EU member state’s competent authority (such as the MHRA in the UK or ANSM in France) oversees the approval and monitoring of wholesalers and resellers.
4. Post-Authorisation Distribution
After a medicine is authorised by the EMA, the marketing authorisation holder may appoint resellers or distributors to sell the medicine in different countries. However, these resellers are not specified or evaluated during the EMA’s drug approval process.
The distribution network is managed by the MAH, who is ultimately responsible for ensuring the product's safety and quality through the supply chain, including the work of distributors.
5. National Regulation of Resellers
National authorities in each member state monitor the resellers or wholesalers, ensuring they comply with GDP and other relevant regulations. These authorities may inspect wholesalers to ensure they are meeting all legal requirements.
Summary
The EMA does not require the stipulation of resellers or distributors as part of the drug approval process. However, after a medicine is authorised, distribution is regulated by national authorities, and resellers must obtain appropriate authorisations at the national level to ensure compliance with Good Distribution Practice (GDP). The primary focus of the EMA during drug approval remains on the manufacturer and supply chain to ensure that the product is consistently safe and effective.

Geron in November -- According to a recent article there are 26 hedge funds invested in Geron one way or the other (26 shades of gray). No one here knows how these funds are structured or what they believe. Geron's PPS is extremely volatile. Geron's PPS and Geron's medical + scientific successes are not closely tied together at this point in time. That could quickly change with some positive news in November.

1/ Nov. 5 (ASH2024 abstracts)
2/ Nov. 7 (Geron financials and Rytelo demand)
3/ EMA + MHRA/UK approvals (hopefully in Nov.) will be carefully followed
4/ MF and AML trial interim updates

November arrives tomorrow which promises to be a very good month for Rytelo, especially Nov. 5 and Nov. 7

Beyond November, we can start to think about the many irons that Geron seems to have in the fire.

1/ Partners in the USA and Europe
2/ Clinical combinations
3/ Use in conjunction with chemotherapy
4/ Preclinical and clinical synergies
5/ Oral forms (used like aspirin)
6/ IMET2.0 (new chemistry and new patents)
7/ Compound #2 (preclinical)
8/ Applications beyond blood cancers
9/ Cancer vaccines
10/ Australia (AML)

I am impressed with the diversity of the ASH2024 abstracts. This is the beginning of many "good vibes". There is more to come on November 7 (Rytelo updates on demand, distribution and interest). There is much to mull over, as the world learns about Geron and Rytelo (medicine, investment, future potential).
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Abstract #352: "Effect of Prior Treatments on the Clinical Activity of Imetelstat in Transfusion-Dependent Patients with Erythropoiesis-Stimulating Agent, Relapsed or Refractory/Ineligible Lower-Risk Myelodysplastic Syndromes"

Oral presentation on Saturday, December 7, 2024 at 4:45 p.m. PT by Uwe Platzbecker, M.D., Department of Hematology, Cellular Therapy, Hemostaseology and Infectious Diseases, Leipzig University Hospital, Leipzig, Germany
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Abstract #4590: "Initial Results from the QTc Substudy of the IMerge Phase 3 Trial Demonstrate Clinically Meaningful Efficacy, Manageable Safety, and Absence of Proarrhythmic Risk in Patients with Lower-Risk Myelodysplastic Syndromes Who Received Prior Therapies Beyond Erythropoiesis Stimulating Agents"

Poster presentation on Monday, December 9, 2024 from 6:00 p.m. - 8 p.m. PT by Rami S. Komrokji, M.D., Vice Chair, Malignant Hematology Department, Moffitt Cancer Center
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Abstract #3210: "Correlation of Patient-Reported Outcomes with Red Blood Cell Transfusion Reduction and Rise in Hemoglobin in Patients with Lower-Risk Myelodysplastic Syndromes in the IMerge Trial"

Poster presentation on Sunday, December 8, 2024 from 6:00 p.m. - 8 p.m. PT by Mikkael Sekeres, MD, University of Miami Health System and Sylvester Comprehensive Cancer Center
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Abstract #998: "Trial Update from IMproveMF, an Ongoing, Open-Label, Dose-Escalation and -Expansion, Phase 1/1B Trial to Evaluate the Safety, Pharmacokinetics, and Clinical Activity of the Novel Combination of Imetelstat with Ruxolitinib in Patients with Intermediate-1, Intermediate-2, or High-Risk Myelofibrosis (MF)"

Oral presentation on Monday, December 9, 2024 at 4:45 p.m. PT by John Mascarenhas, M.D., Professor of Medicine at the Icahn School of Medicine at Mount Sinai
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Abstract #3222: "A Phase II Study Evaluating the Efficacy and Safety of Imetelstat in Patients with Advanced Myelodysplastic Neoplasms or AML Failing HMA-Based Therapy - Interim Analysis Results of the IMpress Study"

Poster presentation on Sunday, December 8, 2024 from 6:00 p.m. - 8 p.m. PT by Uwe Platzbecker, M.D.
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Abstract #52: "Overcoming Ven/Aza Resistance Through Imetelstat-Mediated Lipophagy in Acute Myeloid Leukemia"

Oral presentation on Saturday, December 7, 2024 at 10:15 a.m. PT by Claudia Bruedigam, Team Head, Leukaemia Metabolism Laboratory, QIMR Berghofer Medical Research Institute, Queensland, Australia

Ferroptosis, killing cancer stem cells, AML, Geron collaborators, synergies

This may be the most important paper for Rytelo at ASH2024. Ferroptosis is an exceptional feature of Rytelo (a 2nd way to get at and kill cancer stem cells) that is new and not well understood, at this point in time.

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Abstract #52: "Overcoming Ven/Aza Resistance Through Imetelstat-Mediated Lipophagy in Acute Myeloid Leukemia"

Oral presentation on Saturday, December 7, 2024 at 10:15 a.m. PT by Claudia Bruedigam, Team Head, Leukaemia Metabolism Laboratory, QIMR Berghofer Medical Research Institute, Queensland, Australia

This abstract, submitted by Geron collaborators, shares pre-clinical data identifying imetelstat-mediated, ferroptosis-associated lipidomic alterations in AML cells that correlate with imetelstat treatment responses in vivo. These mechanistic insights may be leveraged to develop an optimized therapeutic strategy using imetelstat to target venetoclax/azacitidine resistant AML subclones.
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Ferroptosis Background

nature; cell death discovery; review articles

Published: 24 January 2024

Ferroptosis: Emerging mechanisms, biological function, and therapeutic potential in cancer and inflammation

Xin Jin, Jiuren Tang, Xiangyu Qiu, Xiaoya Nie, Shengming Ou, Geyan Wu, Rongxin Zhang & Jinrong Zhu

Cell Death Discovery volume 10, Article number: 45 (2024) Cite this article


Abstract

Ferroptosis represents a distinct form of programmed cell death triggered by excessive iron accumulation and lipid peroxidation-induced damage. This mode of cell death differentiates from classical programmed cell death in terms of morphology and biochemistry. Ferroptosis stands out for its exceptional biological characteristics and has garnered extensive research and conversations as a form of programmed cell death. Its dysfunctional activation is closely linked to the onset of diseases, particularly inflammation and cancer, making ferroptosis a promising avenue for combating these conditions. As such, exploring ferroptosis may offer innovative approaches to treating cancer and inflammatory diseases.

Our review provides insights into the relevant regulatory mechanisms of ferroptosis, examining the impact of ferroptosis-related factors from both physiological and pathological perspectives. Describing the crosstalk between ferroptosis and tumor- and inflammation-associated signaling pathways and the potential of ferroptosis inducers in overcoming drug-resistant cancers are discussed, aiming to inform further novel therapeutic directions for ferroptosis in relation to inflammatory and cancer diseases.

The Good Vibes continue:

FOSTER CITY, Calif.--(BUSINESS WIRE)-- Geron Corporation (Nasdaq: GERN), a commercial-stage biopharmaceutical company aiming to change lives by changing the course of blood cancer, today reported financial results for the third quarter of 2024 and recent business highlights.

“This has been a transformative year for Geron, following our first FDA approval and commercial launch of RYTELO in June. The initial full quarter of product revenue from our U.S. launch exceeded our expectations and demonstrates strong execution as a commercial company.

These results also reflect the high unmet need in lower-risk MDS and the compelling value proposition of RYTELO for hematologists and patients, giving us confidence in future continued demand and momentum for RYTELO,” said John A. Scarlett, M.D., Geron’s Chairman and Chief Executive Officer.

“We were also pleased to announce this morning the completion of important synthetic royalty and debt financing transactions with Royalty Pharma and Pharmakon Advisors. We believe that the favorable terms in these transactions reflect the significant commercial potential of RYTELO and provide us with critical flexibility to fuel continued growth and invest in our future.”

Recent Business Highlights

Strong execution in the first full quarter of U.S. launch, with net product revenue for RYTELO (imetelstat) of $28.2 million in the third quarter of 2024.

I

Both November 5th and November 7th look very positive medically and scientifically.

The next hurdles are the full papers at ASH2024 (December 7th) and approvals from Europe (EMA and MHRA/UK). Together, I believe, jumping these hurdles successfully will propel Geron's PPS much higher. We need those European approvals ASAP (some think January 2025, hopefully before), especially for the investment community.
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Previous

Geron's PPS and Geron's medical + scientific successes are not closely tied together at this point in time. That could quickly change with some positive news in November.

1/ Nov. 5 (ASH2024 abstracts)
2/ Nov. 7 (Geron financials and Rytelo demand)
3/ EMA + MHRA/UK approvals (hopefully in Nov.) will be carefully followed
4/ MF and AML trial interim updates

We are in a waiting game now. As I see it, the Rytelo vibes are mostly very "good vibes". I don't see any "bad vibes" at the moment, with ASH2024 (Dec. 7) and European approvals soon. I cannot see beyond that.

The value of Geron is set by the investment community including Goldman Sachs and the 26 or so hedge funds that have positions.
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Previous:

At this point in time, approval means FDA + EMA + MHRA/UK all approving to move the Geron PPS over 5 and substantially beyond.

As I see it, we are only partially approved (FDA approval). Certainly, much of the investment community sees it that way. There is every reason to believe that both the EMA and the MHRA/UK will eventually approve Rytelo. Still, there is no guarantee that this will happen. I am hoping that the approvals will come sometime between ASH2024 abstracts (Nov. 5) and ASH2024 (Dec. 7). Obviously, if either agency rejected Rytelo, that would be a major setback for the company and investors. Some believe that the European agencies will hold off to 2025. That is possible.

Definitely good vibes. PPS clearly bad vibes.
It’s a tale of two cities, at the moment.

Ryan -- Certainly, Geron's current PPS is a "bad vibe". However, much of the investment community is upbeat (see example). There are many other examples (Wainwright, Goldman Sachs, etc.)
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MarketBeat

https://www.marketbeat.com/stocks/NASDAQ/GERN/forecast

Geron (GERN) Stock Forecast and Price Target 2024 - MarketBeat

3 days ago · According to the 11 analysts' twelve-month price targets for Geron, the average price target is $7.05. The highest price target for GERN is $10.00, while the lowest price target for GERN is $4.50. The average price target represents a forecasted upside of 65.88% from the current …

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