| From: Savant | 11/7/2016 10:10:27 AM | | | | | | Geron Announces November Investor Conference Presentation Webcasts
MENLO PARK, Calif., Nov. 07, 2016 (GLOBE NEWSWIRE) -- Geron Corporation (Nasdaq:GERN) today announced that John A. Scarlett, M.D., President and Chief Executive Officer, is scheduled to present at the following investor conferences:
-- Stifel 2016 Healthcare Conference in New York at 9:30 a.m. ET on Tuesday, November 15, 2016. -- Piper Jaffray 28th Annual Healthcare Conference in New York at 12:30 p.m. ET on Wednesday, November 30, 2016. A live audio webcast of each presentation will be available through the Homepage and Investor Relations section of Geron's website under Events. Following the live presentations, the webcasts will be archived and available for replay for a period of 30 days.
About Geron
Geron is a clinical stage biopharmaceutical company focused on the collaborative development of a first-in-class telomerase inhibitor, imetelstat, in hematologic myeloid malignancies. For more information about Geron, visit www.geron.com.
CONTACT: Anna Krassowska, Ph.D. Investor and Media Relations 650-473-7765 investor@geron.com media@geron.com |
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| From: Savant | 12/7/2016 10:07:47 AM | | | | | | Geron Reports Imetelstat Presentations at American Society of Hematology Annual Meeting
MENLO PARK, Calif., Dec. 06, 2016 (GLOBE NEWSWIRE) -- Geron Corporation (Nasdaq:GERN) today announced four presentations of exploratory preclinical and clinical data related to the imetelstat program at the 58th American Society of Hematology (ASH) Annual Meeting and Exposition held in San Diego, California from December 3-6, 2016. The presentations are available on Geron's website at www.geron.com/presentations.
"The imetelstat data presented at ASH this year indicate the potential application of imetelstat in multiple myeloid malignancies," said John A. Scarlett, M.D., Geron's President and Chief Executive Officer. "These presentations reflect the ongoing work by academic scientists, clinical investigators and our colleagues at Janssen to advance the imetelstat program, and support the clinical trials being conducted by Janssen in patients with myelofibrosis and myelodysplastic syndromes, who are in need of new treatment options."
Oral Presentation
Title: The preclinical efficacy of a novel telomerase inhibitor, imetelstat, in AML - a randomized trial in patient-derived xenografts (Abstract #578)
Academic scientists presented data of imetelstat's activity in human acute myeloid leukemia (AML) xenograft models. The preclinical data demonstrated that imetelstat prolonged overall survival of AML xenografts derived from nine out of 15 individual patient samples compared to saline-treated controls, with robust responses associated with favorable cytogenetic risk groups and mutations in molecular pathways controlling DNA damage. The effects on normal human hematopoiesis were modest and predominantly seen in the B-lymphocyte lineage with relative preservation of myeloid and stem cell populations. These data build on previously published preclinical work conducted in patient-derived models of AML and suggest potential application of imetelstat in the treatment of AML.
Poster Presentations
Title: Characterization of Disease, Treatment Patterns, and Outcomes of Patients with Myelofibrosis: Analysis of 2 United States Commercial Claims Databases (Abstract #4769)
Janssen presented an analysis of treatment patterns and outcomes of patients with myelofibrosis (MF) diagnosed between 2006 and 2015 from two United States medical health insurance claims databases. The analysis suggests that many MF patients (43%) received no treatment or supportive care, and only a fraction received ruxolitinib in spite of a favorable median overall survival associated with frontline treatment (30 months compared with 22 months for patients receiving other treatments). Among patients who failed or discontinued frontline ruxolitinib, the median overall survival was seven months, which underscores the need for new treatment options for this disease.
Title: Dynamics of Telomere Length Reflect the Clonal Suppression Seen with the Telomerase Inhibitor Imetelstat in Patients with Essential Thrombocythemia (Abstract #1938)
Academic scientists and clinical investigators from the prior Geron-sponsored proof-of-concept study in patients with essential thrombocythemia (ET) presented new clinical data on telomere length dynamics following treatment with imetelstat. The data showed that in 10 out of 13 ET patients, telomere length in granulocytes was higher after nine months of treatment with imetelstat, and the change correlated with the reduction of JAK2V617F mutational burden. These observations suggest that imetelstat may suppress neoplastic clones and favor recovery of normal hematopoiesis in these patients providing further evidence of the potential disease-modifying activity of imetelstat in hematologic myeloid malignancies.
Title: Telomerase Inhibition with Imetelstat Eradicates -catenin Activated Blast Crisis Chronic Myeloid Leukemia Stem Cells (Abstract #3065)
Academic scientists presented a preliminary investigation into the potential impact of imetelstat on leukemia stem cells in non-clinical models of chronic myeloid leukemia (CML) in blast crisis. The preclinical data suggest that imetelstat plus dasatinib, a standard treatment for CML, may inhibit self-renewal of blast crisis cells in vitro compared with normal bone marrow progenitors. In mouse xenograft models of blast crisis CML, imetelstat treatment reduced the number of leukemia progenitor cells detected in bone marrow and decreased expression of -catenin, which is believed to be required for the self-renewal of leukemic stem cells in CML. This is the first report of data to suggest that imetelstat might inhibit proliferation of malignant progenitors in CML.
About Imetelstat
Imetelstat (GRN163L; JNJ-63935937) is a potent and specific inhibitor of telomerase that is administered by intravenous infusion. This first-in-class compound, discovered by Geron, is a specially designed and modified short oligonucleotide, which targets and binds directly with high affinity to the active site of telomerase. Preliminary clinical data suggest imetelstat has disease-modifying activity by inhibiting malignant progenitor cell clones associated with hematologic malignancies in a relatively select manner. Most commonly reported adverse events in imetelstat clinical studies include fatigue, gastrointestinal symptoms and cytopenias. Patients in these studies also experienced elevated liver enzymes, which resolved to normal or baseline in the majority of patients followed after imetelstat treatment was withdrawn. Imetelstat has not been approved for marketing by any regulatory authority.
About the Collaboration with Janssen
On November 13, 2014, Geron entered into an exclusive worldwide license and collaboration agreement with Janssen Biotech, Inc., to develop and commercialize imetelstat for oncology, including hematologic myeloid malignancies, and all other human therapeutics uses. Under the terms of the agreement, Geron received an upfront payment of $35 million and is eligible to receive additional payments up to a potential total of $900 million for the achievement of development, regulatory and commercial milestones, as well as royalties on worldwide net sales. All regulatory, development, manufacturing and promotional activities related to imetelstat are being managed through a joint governance structure, with Janssen responsible for these activities.
About Geron
Geron is a clinical stage biopharmaceutical company focused on the collaborative development of a first-in-class telomerase inhibitor, imetelstat, in hematologic myeloid malignancies. For more information about Geron, visit www.geron.com.
Use of Forward-Looking Statements |
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| From: tktrimbath | 12/31/2016 9:06:11 PM | | | | | | 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 was $0.426B mid2016 is $0.329B EOY2016)
Geron is developing leading edge biotechnologies based on telomerase, a protein that helps control cell death. The drug is in clinical trials for treating "hematologic myeloid malignancies", which I translate as blood disorders. The potential is very large because controlling cell death has the potential to encourage cells to die on demand, thereby treating cancers; or convincing them not to destroy themselves, which can be an issue in auto-immune disorders.
They are in phase 2 clinical trials, but the data have underwhelmed the investment community.
At one time, the company had four major technologies in development. Now, they are down to one major technology. Diversification within a company is not a guarantee. The clinical trials continue, but I must admit that their past performance is affecting my expectations of their future performance. I am considering selling GERN to buy AST, which happens to be advancing one of Geron's other spun-off technologies.
DISCLOSURE LTBH since 1999 and continuing to hold (though I sold much, partly for diversification, partly to raise funds.)
(I've also collected links to the other discussion boards and my other stocks over on my blog trimbathcreative.wordpress.com |
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| From: Savant | 2/22/2017 10:49:43 AM | | | | | | Geron Announces Conference Call to Discuss Fourth Quarter and Annual 2016 Financial Results
MENLO PARK, Calif., Feb. 22, 2017 (GLOBE NEWSWIRE) -- Geron Corporation (Nasdaq:GERN) will announce its financial results for the fourth quarter and year ended December 31, 2016, on Wednesday, March 1, 2017, after the market close. Geron's management will also host a conference call for analysts and investors on Wednesday, March 1, 2017, at 4:30 p.m. Eastern Time to discuss the company's fourth quarter and annual results as well as recent events.
Participants can access the conference call live via telephone by dialing 877-303-9139 (U.S.); 760-536-5195 (international). The conference ID is 53505663. If accessing the conference call by telephone, please dial in at least 10 minutes early to minimize any delay in joining the call. A live audio-only webcast is also available through the Investors section of our website at www.geron.com or at edge.media-server.com. The audio webcast of the conference call will be available for replay approximately one hour following the live broadcast through April 1, 2017.
About Geron
Geron is a clinical stage biopharmaceutical company focused on the collaborative development of a first-in-class telomerase inhibitor, imetelstat, in hematologic myeloid malignancies. For more information about Geron, visit www.geron.com.
CONTACT: Anna Krassowska, Ph.D. Investor and Media Relations 650-473-7765 investor@geron.com media@geron.com |
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| From: Savant | 3/2/2017 10:35:56 AM | | | | | | Geron Announces Presentation at American Association for Cancer Research Annual Meeting
MENLO PARK, Calif., March 02, 2017 (GLOBE NEWSWIRE) -- Geron Corporation (Nasdaq:GERN) today announced an abstract submitted by Janssen Research & Development, LLC describing non-clinical data on imetelstat has been accepted for presentation as a poster at the 2017 American Association for Cancer Research (AACR) Annual Meeting to be held in Washington, D.C. from April 1-5, 2017. The abstract is available on the AACR website at www.aacr.org.
Abstract Title: Telomerase inhibitor imetelstat in combination with the BCL-2 inhibitor venetoclax enhances apoptosis in vitro and increases survival in vivo in acute myeloid leukemia (Abstract #1101)
AACR Session Title: Combination Therapy 1
Session Date: Monday, April 3, 2017
Session Time: 8:00 a.m. ET - 12:00 p.m. ET
In accordance with AACR policies, abstracts submitted to the AACR Annual Meeting are embargoed from the time of submission. To be eligible for presentation at the AACR Annual Meeting, information contained in the abstract, as well as additional data and information to be presented at the Annual Meeting, may not be made public before the abstract has been presented in connection with the AACR Annual Meeting. |
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| From: tktrimbath | 6/30/2017 8:46:25 PM | | | | | | My semi-annual review of GERN - Mid 2017
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 was $0.329B EOY2016 is $0.433B Mid2017)
Once upon a time, Geron was developing four major disruptive biotechnologies, all that had something to contribute to better and longer lives (Geron, as in gerontology). Now, they've sold off all (see Asterias for stem cell work) except one, telomerase. By properly controlling telomeres, the molecules that help regulate cell death, there is the potential to gain some control over diseases where cells don't die properly (cancer), or cells die too easily (auto-immune disorders.) Their prime clinical trials are aimed at treating hematological disorders (blood disorders).
The good news is that they've entered phase 2/3 clinical trials. Unfortunately, they've taken about two decades to get here, have experienced dilution, and haven't exceeded clinical expectations. With a market cap of close to half a billion dollars, any treatment will have to bring in great revenues to greatly increase the share price. Fortunately, even though hematological disorders don't make headlines (unless they're reworded), proof of the technology can suggest expanding into those other disorders mentioned above.
I don't expect the stock to move much until better and more conclusive clinical trial data elicits a more positive response within the investment community. Psychology plays a role in long term biotechs, especially in ones that have a long history of not meeting technological expectations.
DISCLOSURE LTBH since 1999 and continuing to hold (though I sold much, partly for diversification, partly to raise funds.)
(I've also collected links to the other discussion boards and my other stocks over on my blog trimbathcreative.wordpress.com |
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| From: tktrimbath | 12/31/2017 2:32:23 PM | | | | | | My EOY 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 $0.287B was $0.433B Mid2017)
Geron is a leading edge biotechnology company specializing in the technology of managing telomeres. Telomeres are the molecules at the end of chromosomes. Telomerase is used to manage the telomeres to manage the cell’s ability to die. Cancer is related to cells that don’t die. Autoimmune diseases can be caused by early cell death. Managing telomeres, therefore, has a broad and significant set of applications. The current focus is on hematological disorders, blood diseases. Geron has treatments in phase 2 and phase 3 clinical trials.
Phase 2 and phase 3 clinical trials are far enough along to be encouraging, but the process has been long and the regulatory process is usually difficult for innovative treatments. The potential is great because the ability to manage both aspects of cell death reach far beyond the trials’ hematological focus.
I continue to hold and am cautiously optimistic, but have low expectations. Geron has been developing biotechnologies for decades and has yet to produce a commercially viable treatment. Most of the company’s technologies have been sold off to raise operating funds. This may be a classic dwindling of potential, or it may be the low point from which a strong recovery is begun. Hence, I’ll hold but not buy or sell without better news or greater need.
DISCLOSURE LTBH since 1999 and continuing to hold (though I sold much, partly for diversification, partly to raise funds.)
(I've also collected links to the other discussion boards and my other stocks over on my blog trimbathcreative.wordpress.com |
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| From: Savant | 3/23/2018 6:49:04 PM | | | | | | Yr hi/ $6.68 on 3/22/18 /// Geron Corporation Reports Fourth Quarter and Annual 2017 Financial Results and Recent Events
Conference Call Scheduled for 8:30 a.m. ET on Monday, March 19
MENLO PARK, Calif., March 16, 2018 (GLOBE NEWSWIRE) -- Geron Corporation (Nasdaq:GERN) today reported financial results for the fourth quarter and year ended December 31, 2017 and recent events.
Fourth Quarter and Year-End 2017 Results
For the fourth quarter of 2017, the company reported a net loss of $7.4 million, or $0.05 per share, compared to $8.5 million, or $0.05 per share, for the comparable 2016 period. For 2017, the company reported a net loss of $27.9 million, or $0.18 per share, compared to $29.5 million, or $0.19 per share, for 2016. The company ended 2017 with $109.2 million in cash and investments.
Revenues for the fourth quarter of 2017 were $191,000 compared to $94,000 for the comparable 2016 period. Revenues for 2017 were $1.1 million compared to $6.2 million for 2016. Revenues in 2016 included the full recognition of an upfront payment of $5.0 million from Janssen Pharmaceuticals, Inc. under a license agreement that was signed in September 2016 for certain rights to specialized oligonucleotide backbone chemistry and novel amidates.
Total operating expenses for the fourth quarter of 2017 were $8.0 million compared to $8.9 million for the comparable 2016 period. Total operating expenses for 2017 were $30.3 million compared to $36.8 million for 2016.
Research and development expenses for the fourth quarter of 2017 were $2.5 million compared to $4.1 million for the comparable 2016 period. Research and development expenses for 2017 were $11.0 million compared to $18.0 million for 2016. The decrease in research and development expenses in 2017 compared to 2016 primarily reflects lower costs for the company's proportionate share of clinical development expenses under the imetelstat collaboration with Janssen Biotech, Inc. and reduced personnel related expenses.
General and administrative expenses for the fourth quarter of 2017 were $5.5 million compared to $4.8 million for the comparable 2016 period. General and administrative expenses for 2017 were $19.3 million compared to $18.8 million for 2016. The increase in general and administrative expenses in 2017 compared to 2016 primarily reflects higher non-cash stock-based compensation expense and increased consulting costs, partially offset by lower legal costs.
Interest and other income for the fourth quarter of 2017 was $375,000 compared to $321,000 for the comparable 2016 period. Interest and other income for 2017 was $1.4 million compared to $1.2 million for 2016. The increase in interest and other income for 2017 compared to 2016 primarily reflects higher yields on the company's marketable securities portfolio.
Fourth Quarter 2017 and Recent Events
IMerge
IMerge is the ongoing Phase 2/3 clinical trial of imetelstat in red blood cell (RBC) transfusion-dependent patients with lower risk myelodysplastic syndromes (MDS) who are refractory or resistant to treatment with an erythropoiesis stimulating agent (ESA).
Medical Conference Presentation. At the American Society of Hematology (ASH) annual meeting in December 2017, preliminary data as of October 2017 were presented from the first 32 patients enrolled in Part 1 of IMerge. The data showed that among the subset of 13 patients who had not received prior treatment with either lenalidomide or a hypomethylating agent (HMA) and did not have a deletion 5q chromosomal abnormality (non-del(5q)), 54% achieved RBC transfusion-independence (TI) lasting at least 8 weeks, including 31% who achieved a 24-week RBC-TI. In the overall trial population, the rates of 8- and 24-week RBC-TI were 38% and 16%, respectively. Cytopenias, particularly neutropenia and thrombocytopenia, were the most frequently reported adverse events, which were predictable, manageable and reversible. Imetelstat presentations are available through the Publications page in the R&D section of Geron's website at www.geron.com/r-d/publications.
"With the preliminary data from IMerge presented at ASH, we now have clinical data in three blood cancers, ET, MF and MDS, where imetelstat exhibits potential disease modifying activity by inhibiting the progenitor cells of the malignant clones that drive the underlying diseases," said John A. Scarlett, M.D., Geron's President and Chief Executive Officer.
Investor Event. Geron hosted an analyst and investor meeting in December 2017 during which an IMerge clinical investigator presented and discussed the data presented at ASH, as well as a description of the unmet medical need in lower risk MDS. The archived webcast of the presentation is available for replay through the Investors section of Geron's website under Events.
Clinical Development. Based on the preliminary data from the 13-patient subset, Janssen expanded Part 1 of IMerge to enroll approximately 20 additional patients who were na?ve to lenalidomide and HMA treatment and non-del(5q) to increase the experience and confirm the benefit-risk profile of imetelstat in this refined target patient population. The first patient in the expanded Part 1 was dosed in November 2017 and enrollment was completed in February 2018.
Regulatory Designation. In October 2017, the United States Food and Drug Administration (FDA) granted Fast Track designation to imetelstat for the potential treatment of adult patients with transfusion-dependent anemia due to Low or Intermediate-1 risk MDS who are non-del(5q) and who are refractory or resistant to treatment with an ESA. Janssen sponsored the application for Fast Track designation using preliminary data from IMerge.
IMbark
IMbark is the ongoing Phase 2 clinical trial to evaluate two doses of imetelstat in intermediate-2 or high-risk myelofibrosis (MF) patients who are refractory to or have relapsed after treatment with a JAK inhibitor.
Clinical Development. Janssen completed a third internal data review of IMbark in March 2018, based on a January 2018 data cut, to enable a protocol amendment to allow the long-term treatment and follow up of patients, including for survival, and the Collaboration's Joint Steering Committee (JSC) made the following observations and implemented the following actions:
-- The safety profile was consistent with prior clinical trials of imetelstat in hematologic malignancies, and no new safety signals were identified. -- Outcome measures for efficacy, including spleen volume responses and reductions in Total Symptom Score remain consistent with the prior data reviews. -- With a median follow up of approximately 19 months, the median overall survival has not been reached in either dosing arm. -- The trial is officially being closed to new patient enrollment. More than 100 patients have been enrolled in IMbark to date, which is expected to be adequate to assess overall survival. Patients who remain in the treatment phase may continue to receive imetelstat, and until the primary analysis, all safety and efficacy assessments are being conducted as planned in the protocol, including following patients, to the extent possible, until death to enable an assessment of overall survival. -- Based on the rate of deaths occurring in the trial, the protocol-specified primary analysis, which includes an assessment of overall survival, will begin by the end of the second quarter of 2018. -- Upon the protocol-specified primary analysis, the main trial will be completed. The IMbark protocol is being amended to establish an extension phase of the trial to enable patients remaining in the treatment phase to continue to receive imetelstat treatment per investigator discretion. During the extension phase, standard data collection will primarily consist of safety information.
Upcoming 2018 Events
Following completion of the IMbark protocol-specified primary analysis, Janssen must notify Geron whether it elects to maintain the license rights and continue the development of imetelstat in any indication (Continuation Decision). Geron expects the protocol-specified primary analysis for IMbark to begin by the end of the second quarter of 2018. As such, the company expects the Continuation Decision to occur by the end of the third quarter of 2018.
Conference Call and Webcast
At 8:30 a.m. ET on March 19, 2018, Geron's management will host a conference call to discuss the company's fourth quarter and annual results as well as recent company events.
Participants can access the conference call live via telephone dialing 877-303-9139 (U.S.); 760-536-5195 (international). The conference ID is 3564078. A live audio-only webcast is also available through the Investors section of our website at www.geron.com or at edge.media-server.com. The audio webcast of the conference call will be available for replay approximately one hour following the live broadcast through April 20, 2018.
About Geron
Geron is a biopharmaceutical company supporting the clinical stage development 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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