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   Biotech / MedicalGeron Corp.


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From: Savant7/1/2020 5:35:32 PM
1 Recommendation   of 3521
 
Geron Receives Positive Opinion from the EMA Committee for Orphan Medicinal Products for Orphan Drug Designation in the European Union for Imetelstat to Treat Myelodysplastic Syndromes -- Designation would provide 10-year period of marketing exclusivity in the European Union after product approval -- Patients are currently enrolling in a Geron-sponsored Phase 3 clinical trial in lower risk myelodysplastic syndromes MENLO PARK, Calif., July 01, 2020 (GLOBE NEWSWIRE) -- Geron Corporation (Nasdaq: GERN), a late-stage clinical biopharmaceutical company, today announced that the European Medicines Agency (EMA) Committee for Orphan Medicinal Products (COMP) issued a positive opinion on the Company's application for orphan drug designation of its first-in-class telomerase inhibitor, imetelstat, as a potential treatment for myelodysplastic syndromes (MDS). The Company expects that the European Commission, based on this positive opinion of the COMP, will formally grant the orphan drug designation for the European Union (EU) by the end of July. Imetelstat has already been granted orphan drug designation by the United States Food and Drug Administration as a potential treatment for MDS. "The positive opinion from the COMP acknowledges the compelling clinical data from our Phase 2 clinical trial that imetelstat has the potential to provide a clinically relevant advantage to lower risk MDS patients who are transfusion dependent and have failed to respond to treatment with erythropoiesis stimulating agents," said John A. Scarlett, Chairman and Chief Executive Officer. "Our ongoing IMerge Phase 3 clinical trial in lower risk MDS is being conducted at multiple sites around the world, and data from this trial are intended to support global regulatory filings." To qualify for orphan drug designation in the EU, an investigational medicine must be intended to treat a seriously debilitating or life-threatening condition that affects fewer than five in 10,000 people in the EU, and there must be sufficient non-clinical or clinical data to suggest the investigational medicine may produce clinically relevant outcomes. EMA orphan drug designation provides companies with certain benefits and incentives, including clinical protocol assistance, differentiated evaluation procedures for Health Technology Assessments in certain countries, access to a centralized marketing authorization procedure valid in all EU member states, reduced regulatory fees and ten years of market exclusivity. Ongoing IMerge Phase 3 Clinical Trial The IMerge Phase 3 clinical trial is a double-blind, randomized, placebo-controlled clinical trial with registration intent. The trial is designed to enroll approximately 170 patients with lower risk transfusion dependent MDS who are relapsed or refractory to an ESA, have not received prior treatment with either a hypomethylating agent (HMA) or lenalidomide and who are non-del(5q). Geron expects to complete patient enrollment by the end of the first quarter of 2021 and top-line results to be available in the second half of 2022. About Myelodysplastic Syndromes MDS is a group of blood disorders in which the proliferation of malignant progenitor cells produces multiple malignant cell clones in the bone marrow resulting in disordered and ineffective production of the myeloid lineage, which includes red blood cells, white blood cells and platelets. Chronic anemia is the predominant clinical problem in patients who have lower risk MDS. Many of these patients become dependent on red blood cell transfusions due to low hemoglobin. Serial red blood cell transfusions can lead to elevated levels of iron in the blood and other tissues, which the body has no normal way to eliminate. Iron overload is a potentially dangerous condition. Studies in patients with MDS have shown that iron overload resulting from regular red blood cell transfusions is associated with lower quality of life, shorter overall survival and a higher risk of developing acute myeloid leukemia. About Imetelstat Imetelstat is a novel, first-in-class telomerase inhibitor exclusively owned by Geron and being developed in hematologic myeloid malignancies. Early clinical data suggest imetelstat may have disease-modifying activity through the apoptosis of malignant stem and progenitor cells, which allows potential recovery of normal hematopoiesis. Geron's imetelstat development program includes two ongoing or planned registration-enabling studies, IMerge, an ongoing Phase 2/3 clinical trial in lower risk myelodysplastic syndromes (MDS), and a planned Phase 3 clinical trial in refractory myelofibrosis (MF) expected to be open for patient screening and enrollment in the first quarter of 2021. Imetelstat has been granted Fast Track designation by the U.S. Food and Drug Administration for both the treatment of patients with non-del(5q) lower risk MDS who are refractory or resistant to an erythropoiesis-stimulating agent and for patients with Intermediate-2 or High-risk MF whose disease has relapsed after or is refractory to janus kinase (JAK) inhibitor treatment. About Geron Geron is a late-stage clinical biopharmaceutical company focused on the development and potential commercialization of a first-in-class telomerase inhibitor, imetelstat, in hematologic myeloid malignancies. For more information about Geron, visit www.geron.com.

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From: tktrimbath12/31/2020 7:30:30 PM
1 Recommendation   of 3521
 
My End Of Year Review of GERN

INTRO Here's my semi-annual exercise to see if I remember why I own the stocks I own, and so I can check back and see if their stories have changed. I post in case it helps others too.

Geron

GERN (market cap is $0.494B was $0.677B)

Geron is a biotech directed to gerontology issues. Originally they were pursuing several technologies but over the decades they've had to sell them off to financially sustain the remainder of the company. Currently, the prime technology is directed at telomere management, particularly for blood disorders. If successful, the technology should be applicable to other disorders like autoimmune diseases as well as cancers.

The good news is that the company has made it to Phase 3. A hurdle ahead of them is the FDA's tendency to require additional efforts from innovative technologies. (See Dendreon's history with Provenge for prostate cancer.) Their current trial plan may suffice. Their current trial plan still requires years of effort, then the approval process, then implementation, then adoption by the medical community, then hopefully getting paid sufficiently to make the company profitable. Hence, high risk. The ability to expand to other treatments is also the potential for high reward financially and in a humane sense.

I continue to hold, but have sold off most of my shares to concentrate on more near-term opportunities. I haven't sold off all, though, as I feel clinical trial news can be surprisingly positive without warning and the investment community's response can be more rapid than mine.

DISCLOSURE LTBH since 1999 and continuing to hold. I might consider buying more, but will probably wait for substantial, quantitative results to be made public - which would spark a spike that might price me out of the sale. Stay tuned.

(I've also collected links to the other discussion boards and my other stocks over on my blog trimbathcreative.net )

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From: tktrimbath6/30/2021 7:49:20 PM
   of 3521
 
My mid-year review of GERN - crossposted, blog to go live soon

INTRO Here's my semi-annual exercise to see if I remember why I own the stocks I own, and so I can check back and see if their stories have changed. I post in case it helps others too.

Geron

GERN (market cap is $0.4549B was $0.494B)

Geron is a leading edge biotech company focused on cancer treatments, but with a telomerase technology that could have more uses than the current target of hematological (blood) disorders. They are in clinical trials (phase 3) and intend to apply for FDA approval with treatments to begin within a few years.

Geron originally had grander goals, as if curing cancer wasn't enough. They sold off their cloning business, as well as their stem cell technology (see Lineage Cell Therapeutics, LCTX, for one of my holdings that includes that spin-off). That grander company vision is from over twenty years ago. This is what is left, and what is left may be more than enough. Because their technology is so advanced they may encounter hurdles as the FDA is very conservative and cautious, even as patients could be benefiting from the treatment. If the unmet need is great enough, there may be pressure to encourage an expedited approval. That's a hard thing to predict.

One bit of encouraging news: Recently they've advanced enough that I had to check out their web site to get the dates and phases correct. That wasn't the case for many years.

"The Company currently is conducting two Phase 3 clinical trials: IMerge in lower risk myelodysplastic syndromes and IMpactMF in refractory myelofibrosis." No wonder I couldn't quote that. That's biotech.

"The Company is beginning pre-commercial activities, including building the internal infrastructure to support a commercial launch. Assuming approval of the NDA, the Company forecasts the commercial launch of imetelstat in lower risk MDS in the United States to be in 2024." That's easier to understand. 2024 seemed far away years ago, but time progresses regardless. Hopefully the trials, approval, treatments, and commercial sustainability do too.



DISCLOSURE LTBH since 1999 and continuing to hold. I might consider buying more now that substantial, quantitative results are to be made public. Stay tuned.

(I've also collected links to the other discussion boards and my other stocks over on my blog trimbathcreative.net )

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From: Savant8/17/2021 6:12:40 PM
   of 3521
 
Completion of Enrollment in IMerge Phase 3 Expected in the Fourth Quarter of 2021
Currently, 91% enrolled.

Investor Day Planned for November

Second Quarter and Year to Date 2021 Financial Results Also Reported

Conference Call Scheduled for 4:30 p.m. ET Today

FOSTER CITY, Calif.--(BUSINESS WIRE)--August 16, 2021--

Geron Corporation (Nasdaq: GERN), a late-stage clinical biopharmaceutical company, today reported updates on the IMerge Phase 3 trial in lower risk MDS and financial results for the second quarter ended June 30, 2021. The Company will host a conference call today at 4:30 p.m. ET to discuss these updates and current events. As of June 30, 2021, the Company had $239.1 million in cash and marketable securities. These financial resources, combined with expected future non-dilutive funding under the current debt facility, are expected to fund operations through the end of the first quarter of 2023.

"We are pleased with the achievement of 91% of the planned enrollment in IMerge Phase 3 and expect the trial to be fully enrolled in the fourth quarter of 2021. In addition, the expected timing for top-line results in IMerge Phase 3 has been accelerated by three months to the first quarter of 2023," said John A. Scarlett, M.D., Chairman and Chief Executive Officer. "By confirming the results from IMerge Phase 2 in the current IMerge Phase 3, including the depth, breadth and durability of transfusion independence, as well as the potential for disease modification, we expect imetelstat to be a highly differentiated product in lower risk MDS in comparison to drugs currently approved or in development today. We look forward to bringing this innovative and important drug to lower risk MDS patients, for whom there remain limited treatment options."

Phase 3 Clinical Development

Ongoing IMerge Phase 3 Clinical Trial in Lower Risk Myelodysplastic Syndromes (LR MDS)

As of August 12, 2021, the Company had achieved 91% of the planned enrollment in IMerge Phase 3. The Company expects the trial to be fully enrolled in the fourth quarter of 2021. In July 2021, a regularly scheduled Independent Data Monitoring Committee (IDMC) meeting was held, and the IDMC recommended that the trial continue without modification.

The significantly longer enrollment period caused by the COVID-19 pandemic has enabled a longer follow-up period than previously projected. As a result, the Company determined that the clinical cut-off date for the primary analysis could occur three months earlier than originally planned, which the Company expects will still provide a sufficiently mature data set to assess the benefit-risk profile of imetelstat. The Company has shortened the follow-up period after the last patient has been enrolled from 15 months to 12 months to enable the earlier clinical cut-off date for the primary analysis. With the revised 12-month follow-up period for the primary analysis, the Company now projects that top-line results from IMerge Phase 3 will be available in the first quarter of 2023.

For further information about IMerge Phase 3, including enrollment criteria, locations, and current status, please visit ClinicalTrials.gov/NCT02598661.

Ongoing IMpactMF Phase 3 Clinical Trial in Refractory Myelofibrosis (MF)

The Company plans to engage over 180 sites to participate in IMpactMF across North America, South America, Europe, Australia, and Asia, of which 55 sites are currently open for enrollment. In the second quarter of 2021, the first patient was dosed in IMpactMF. The Company continues to expect the interim analysis to occur in 2024 and the final analysis in 2025.

As the only MF Phase 3 trial with overall survival (OS) as the primary endpoint, the Company expects that success in this trial would provide unequivocal proof of clinical benefit for patients, as well as further evidence of disease-modifying activity with imetelstat treatment.

For further information about IMpactMF, including enrollment criteria, locations, and current status, please visit ClinicalTrials.gov/NCT04576156.

Investor Day

In November 2021, Geron plans to host a virtual event for investors and analysts at which management and key opinion leaders will discuss the following topics:

-- Imetelstat's potential for disease modification in LR MDS and refractory MF; -- Expected path to commercializing imetelstat; -- Expansion of imetelstat development plans, including new studies in additional indications; and -- An early discovery program in second generation telomerase inhibitors.

Recently Reported Data in June 2021

Poster Presentations at EHA2021 Virtual Congress

In June 2021, two poster presentations of imetelstat Phase 2 data were made at the European Hematology Association (EHA) Virtual Congress. These presentations, available on Geron's website, further support imetelstat's potentially differentiated approach to inhibiting telomerase activity to target the malignant stem and progenitor cells in the bone marrow responsible for the underlying hematologic myeloid malignancies.

The first poster presented new data and analyses of the clinical efficacy of imetelstat in molecularly defined subtypes based on cytogenetic and mutation profiles for patients in the IMerge Phase 2 clinical trial in lower risk MDS. As reported at previous EHA meetings, meaningful and durable transfusion independence was observed in patients from IMerge Phase 2, including transfusion-free periods greater than one year, as well as substantial increases in hemoglobin. The new poster presentation reported clinical responses across different cytogenetic and molecularly defined categories, and these responses were independent of mutation status or number of mutations. These data support the unique telomerase inhibition mechanism of action of imetelstat and the potential to target the malignant stem and progenitor cells of the underlying disease. The Company is exploring these observations further in the ongoing IMerge Phase 3.

The second poster at EHA presented new analyses of safety data from the IMbark Phase 2 trial in MF and the IMerge Phase 2 trial in lower risk MDS to understand the characteristics of hematologic and non-hematologic adverse events. These analyses highlighted that the imetelstat-related cytopenias are short, reversable and with limited clinical consequence when managed with the dose modification guidelines in the protocols.

Publication of IMbark Phase 2 Data in Journal of Clinical Oncology

Efficacy, safety and biomarker results from the IMbark Phase 2 clinical trial were published in the Journal of Clinical Oncology in a paper entitled "Randomized, Single-Blind, Multicenter Phase II Study of Two Doses of Imetelstat in Relapsed or Refractory Myelofibrosis." The publication, which is available online, highlights the clinical benefits observed in the study, including symptom response and OS, as well as evidence of disease-modifying activity from biomarker and bone marrow fibrosis assessments.

The trial design for IMpactMF is intended to confirm the IMbark Phase 2 results and to enable imetelstat to be a potential treatment option for MF patients who no longer respond to currently approved JAK inhibitor therapies. Currently, there is no approved drug for patients who fail or no longer respond to JAK inhibitor therapies, and median survival for such MF patients after discontinuation from ruxolitinib is only approximately 14 -- 16 months, representing a significant unmet medical need.

Second Quarter and Year-to-Date 2021 Results

For the second quarter of 2021, the Company reported a net loss of $29.6 million, or $0.09 per share, compared to $15.8 million, or $0.06 per share, for the comparable 2020 period. Net loss for the first six months of 2021 was $57.4 million, or $0.18 per share, compared to $32.2 million, or $0.14 per share, for the comparable 2020 period.

Revenues for the three and six months ended June 30, 2021 were $107,000 and $244,000, respectively, compared to $43,000 and $95,000 for the comparable 2020 periods. Revenues in 2021 and 2020 primarily reflect estimated royalties from sales of cell-based research products from the Company's divested stem cell assets. In connection with the divestiture of Geron's human embryonic stem cell assets, including intellectual property and proprietary technology, to Lineage Cell Therapeutics, Inc. (formerly BioTime, Inc., which acquired Asterias Biotherapeutics, Inc.) in 2013, Geron is entitled to receive royalties on sales from certain research or commercial products utilizing Geron's divested intellectual property.

Total operating expenses for the three and six months ended June 30, 2021 were $29.0 million and $57.6 million, respectively, compared to $16.8 million and $33.7 million for the comparable 2020 periods.

Research and development expenses for the three and six months ended June 30, 2021 were $21.9 million and $43.1 million, respectively, compared to $10.8 million and $21.6 million for the comparable 2020 periods. The increase in research and development expenses for the three and six months ended June 30, 2021, compared to the same periods in 2020, primarily reflects increased clinical development costs associated with conducting two Phase 3 clinical trials, higher imetelstat manufacturing costs for producing validation batches at contract manufacturers to enable future production of imetelstat for clinical and commercial purposes and higher personnel-related costs for additional headcount.

General and administrative expenses for the three and six months ended June 30, 2021 were $7.1 million and $14.5 million, respectively, compared to $6.0 million and $12.1 million for the comparable 2020 periods. The increase in general and administrative expenses for the three and six months ended June 30, 2021, compared to the same periods in 2020, primarily reflects new costs in connection with pre-commercial activities, including modernizing the internal infrastructure to support a commercial launch, and higher legal costs.

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From: tktrimbath9/23/2021 1:22:01 PM
   of 3521
 
Bought a bit more GERN


Just bought some more $GERN because...


Let me think...


Because after holding the stock for two decades


I decided to hold a bit more


Because surely within the next few years they will finally get FDA approval? (Note the '?'.)

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From: Savant10/28/2021 10:02:11 AM
1 Recommendation   of 3521
 
  • Geron announced that imetelstat, the company's first in class telomerase inhibitor, has been granted an Innovation Passport, which is the first prescribed entry point to the Innovative Licensing and Access Pathway (ILAP) launched in the UK by the Medicines and Healthcare products Regulatory Agency (MHRA) in January 2021, post-Brexit.
  • Key benefits of being within ILAP include a 150-day accelerated assessment and rolling review of a Marketing Authorization Application as well as opportunities for frequent interactions with the review staff at the MHRA and its partner agencies to discuss imetelstat's development, regulatory plans, and reimbursement plans.

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From: Savant11/19/2021 10:55:10 AM
   of 3521
 
Geron Corporation (Nasdaq: GERN) today reported that it has granted a non-statutory stock option to purchase an aggregate of 80,000 shares of Geron common stock as an inducement to a newly hired employee in connection with commencement of employment with the Company.

The stock option was granted on November 17, 2021 at an exercise price of $1.42 per share, which is equal to the closing price of Geron common stock on the date of grant. The stock option has a 10-year term and vests over four years, with 12.5% of the shares underlying the option vesting on the six-month anniversary of commencement of employment and the remaining shares vesting over the following 42 months in equal installments of whole shares, subject to continued employment with Geron through the applicable vesting dates. The option was granted as material inducement to employment in accordance with Nasdaq Listing Rule 5635(c)(4) and is subject to the terms and conditions of the stock option agreement covering the grant and Geron's 2018 Inducement Award Plan, which was adopted December 14, 2018 and provides for the granting of stock options to new employees.

About Geron

Geron is a late-stage clinical biopharmaceutical company focused on the development and potential commercialization of a first-in-class telomerase inhibitor, imetelstat, in hematologic malignancies. The Company currently is conducting two Phase 3 clinical trials: IMerge in lower risk myelodysplastic syndromes and IMpactMF in refractory myelofibrosis. For more information about Geron, visit www.geron.com.

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