GERN Geron Corporation

1.22
-0.01  -1%
Previous Close 1.23
Open 1.24
52 Week Low 1.2
52 Week High 2.355
Market Cap $388,652,360
Shares 318,567,508
Float 316,398,930
Enterprise Value $210,588,034
Volume 3,033,451
Av. Daily Volume 10,256,177
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Upcoming Catalysts

Drug Stage Catalyst Date
Imetelstat - (IMerge Study)
Myelodysplastic syndromes
Phase 3
Phase 3
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Imetelstat (IMpactMF)
Myelofibrosis
Phase 3
Phase 3
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Latest News

  1. Geron Corporation (NASDAQ:GERN) today reported that it has granted non-statutory stock options to purchase an aggregate of 130,000 shares of Geron common stock as inducements to newly hired employees in connection with commencement of employment with the Company.

    The stock options were granted on July 21, 2021 at an exercise price of $1.33 per share, which is equal to the closing price of Geron common stock on the date of grant. The stock options have a 10-year term and vest over four years, with 12.5% of the shares underlying the options 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 Corporation (NASDAQ:GERN) today reported that it has granted non-statutory stock options to purchase an aggregate of 130,000 shares of Geron common stock as inducements to newly hired employees in connection with commencement of employment with the Company.

    The stock options were granted on July 21, 2021 at an exercise price of $1.33 per share, which is equal to the closing price of Geron common stock on the date of grant. The stock options have a 10-year term and vest over four years, with 12.5% of the shares underlying the options 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 options were granted as material inducements to employment in accordance with Nasdaq Listing Rule 5635(c)(4) and are subject to the terms and conditions of the stock option agreements covering the grants 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 myeloid 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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  2. Results reinforce imetelstat's novel approach to the treatment of myelofibrosis (MF)

    Data support ongoing IMpactMF Phase 3 clinical trial

    Geron Corporation (NASDAQ:GERN), a late-stage clinical biopharmaceutical company, today announced the publication of data from the IMbark Phase 2 clinical trial 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 highlights the clinical benefits observed in the study, including symptom response and overall survival, as well as the evidence of disease-modifying activity from biomarker and bone marrow fibrosis assessments.

    "We are pleased with the publication of…

    Results reinforce imetelstat's novel approach to the treatment of myelofibrosis (MF)

    Data support ongoing IMpactMF Phase 3 clinical trial

    Geron Corporation (NASDAQ:GERN), a late-stage clinical biopharmaceutical company, today announced the publication of data from the IMbark Phase 2 clinical trial 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 highlights the clinical benefits observed in the study, including symptom response and overall survival, as well as the evidence of disease-modifying activity from biomarker and bone marrow fibrosis assessments.

    "We are pleased with the publication of our IMbark Phase 2 data in the high-impact Journal of Clinical Oncology. This highlights the importance of the study data in the advancement of treatment options for MF patients who no longer respond to currently approved JAKi therapies," said Aleksandra Rizo, M.D., Ph.D., Geron's Chief Medical Officer. "Imetelstat is a novel telomerase inhibition approach that may alter the course of the disease in patients with myelofibrosis. We look forward to confirming these results in our ongoing IMpactMF Phase 3 clinical trial in refractory MF."

    The publication reports efficacy, safety and biomarker results from the IMbark Phase 2 clinical trial and is available online. As stated in the paper, IMbark tested two imetelstat doses and the 9.4 mg/kg dose every three weeks demonstrated clinical benefits in symptom response rate, with an acceptable safety profile for this poor-risk JAKi relapsed/refractory MF patient population. Biomarker and bone marrow assessments suggested selective effects on the malignant clone.

    "In these heavily pre-treated patients with high disease burden whose outcome is dismal, imetelstat treatment resulted in multiple clinical meaningful benefits, including symptom response and potential improvement in overall survival," said John Mascarenhas, M.D., Associate Professor of Medicine at the Icahn School of Medicine at Mount Sinai, and lead author of the paper. "In addition, the reductions in key driver mutations of the disease that were also correlated to clinical benefits suggest disease-modifying activity of imetelstat by targeting the underlying MF malignant clones, which differentiates imetelstat from other therapeutic agents currently in development for MF."

    Ongoing IMpactMF Phase 3 Clinical Trial

    IMpactMF is an open label, randomized, controlled Phase 3 clinical trial with registrational intent. The trial is planned to enroll approximately 320 patients with Intermediate-2 or High-risk myelofibrosis who are refractory to prior treatment with a JAK inhibitor, also referred to as refractory MF. Patients will be randomized to receive either imetelstat or best available therapy. The primary endpoint is overall survival (OS). Key secondary endpoints include symptom response, spleen response, progression free survival, complete response, partial response, clinical improvement, duration of response, safety, pharmacokinetics, and patient reported outcomes.

    IMpactMF is currently enrolling patients. For further information about IMpactMF, including enrollment criteria, locations and current status, visit ClinicalTrials.gov/NCT04576156.

    About Myelofibrosis (MF)

    Myelofibrosis, a type of myeloproliferative neoplasm, is a chronic blood cancer in which abnormal or malignant precursor cells in the bone marrow proliferate rapidly, causing scar tissue, or fibrosis, to form. People with MF may have abnormally low or high numbers of circulating red blood cells, white blood cells or platelets, and abnormally high numbers of immature cells in the blood or bone marrow. MF patients can also suffer from debilitating constitutional symptoms, such as drenching night sweats, fatigue, severe itching, or pruritus, abdominal pain, fever and bone pain.

    Approximately 70% of MF patients are classified as having Intermediate-2 or High-risk disease, as defined by the Dynamic International Prognostic Scoring System Plus. There are more than 35,000 patients worldwide and more than 13,000 patients in the U.S. living with Intermediate-2 or High-risk MF. The only drug therapies approved for treating these MF patients are JAK inhibitors (JAKi). Currently, MF patients who fail or no longer respond to JAKi treatment have no or limited options, resulting in shortened median overall survival.

    About Imetelstat

    Imetelstat is a novel, first-in-class telomerase inhibitor exclusively owned by Geron and being developed in hematologic myeloid malignancies. Data from Phase 2 clinical trials provide strong evidence that imetelstat targets telomerase to inhibit the uncontrolled proliferation of malignant stem and progenitor cells in hematologic myeloid malignancies resulting in malignant cell apoptosis and potential disease-modifying activity. Imetelstat has been granted Fast Track designation by the United States 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 inhibitor (JAKi) 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. 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.

    Use of Forward-Looking Statements

    Except for the historical information contained herein, this press release contains forward-looking statements made pursuant to the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. Investors are cautioned that such statements, include, without limitation, those regarding: (i) that IMbark clinical data provide strong evidence of disease-modifying activity by imetelstat; (ii) that imetelstat may alter the course of the disease in patients with myelofibrosis; and (iii) other statements that are not historical facts, constitute forward looking statements. These statements involve risks and uncertainties that can cause actual results to differ materially from those in such forward-looking statements. These risks and uncertainties, include, without limitation, risks and uncertainties related to: (a) whether regulatory authorities permit the further development and commercialization of imetelstat on a timely basis, or at all, without any clinical holds; (b) whether imetelstat is demonstrated to be safe and efficacious in IMpactMF and other clinical trials; (c) whether any efficacy or safety results may cause the benefit-risk profile of imetelstat to become unacceptable; (d) whether imetelstat actually demonstrates disease-modifying activity in patients; (e) whether the Company maintains sufficient funding to complete IMpactMF; (f) whether the current or evolving effects of the COVID-19 pandemic and resulting global economic and financial disruptions will materially and adversely impact Geron's business and business prospects, its financial condition and the future of imetelstat; (g) whether Geron overcomes all of the potential delays and other adverse impacts caused by the current or evolving effects of the COVID-19 pandemic, and overcomes all the enrollment, clinical, safety, efficacy, technical, scientific, intellectual property, manufacturing and regulatory challenges in order to complete IMpactMF; and (h) whether imetelstat has adequate patent protection and freedom to operate. Additional information on the above risks and uncertainties and additional risks, uncertainties and factors that could cause actual results to differ materially from those in the forward-looking statements are contained in Geron's periodic reports filed with the Securities and Exchange Commission under the heading "Risk Factors," including Geron's quarterly report on Form 10-Q for the quarter ended March 31, 2021. Undue reliance should not be placed on forward-looking statements, which speak only as of the date they are made, and the facts and assumptions underlying the forward-looking statements may change. Except as required by law, Geron disclaims any obligation to update these forward-looking statements to reflect future information, events or circumstances.

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  3. Geron Corporation (NASDAQ:GERN), a late-stage clinical biopharmaceutical company, today announced that two poster presentations of new clinical data and analyses related to imetelstat, the Company's first-in-class telomerase inhibitor, are now available on Geron's website as well as to participants of the EHA2021 Virtual Congress.

    "These poster presentations further support imetelstat's differentiated approach to potentially target the malignant stem and progenitor cells in the bone marrow by inhibiting telomerase activity," said Aleksandra Rizo, M.D., Ph.D., Geron's Chief Medical Officer. "Through this novel mechanism of action, imetelstat has the potential to alter the course of MDS and MF which distinguishes it from other treatments currently…

    Geron Corporation (NASDAQ:GERN), a late-stage clinical biopharmaceutical company, today announced that two poster presentations of new clinical data and analyses related to imetelstat, the Company's first-in-class telomerase inhibitor, are now available on Geron's website as well as to participants of the EHA2021 Virtual Congress.

    "These poster presentations further support imetelstat's differentiated approach to potentially target the malignant stem and progenitor cells in the bone marrow by inhibiting telomerase activity," said Aleksandra Rizo, M.D., Ph.D., Geron's Chief Medical Officer. "Through this novel mechanism of action, imetelstat has the potential to alter the course of MDS and MF which distinguishes it from other treatments currently approved or in development. We look forward to confirming these results in our ongoing Phase 3 clinical trials, IMerge Phase 3 in lower risk MDS and IMpactMF in refractory MF."

    Title: Efficacy of Imetelstat is Independent of Molecular Subtypes in Heavily Transfused Non-Del(5q) Lower Risk MDS (LR-MDS) Relapsed/Refractory (R/R) to Erythropoiesis Stimulating Agents (ESA)

    Poster Code: EP910

    New data and analyses were presented on the clinical efficacy of imetelstat in molecularly defined subtypes based on cytogenetic and mutation profiles for patients in the IMerge Phase 2 clinical trial. As reported at previous EHA meetings, meaningful and durable transfusion independence were observed in patients from IMerge Phase 2, including transfusion-free periods greater than one year, as well as substantial increases in hemoglobin. The current presentation reported clinical responses across different cytogenetic and molecularly defined categories whereby 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.

    Title: Imetelstat Demonstrates an Acceptable Safety Profile in Myeloid Malignancies

    Poster Code: EP1106

    Safety data from the Phase 2 IMbark and IMerge trials were further analyzed 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. These data are further evidence for the on-target effect of imetelstat based on the selective reduction of malignant cells in the bone marrow through telomerase inhibition resulting in the observed meaningful clinical benefits for patients in the Phase 2 trials.

    About Imetelstat

    Imetelstat is a novel, first-in-class telomerase inhibitor exclusively owned by Geron and being developed in hematologic myeloid malignancies. Data from Phase 2 clinical trials provide strong evidence that imetelstat targets telomerase to inhibit the uncontrolled proliferation of malignant stem and progenitor cells in hematologic myeloid malignancies resulting in malignant cell apoptosis and potential disease-modifying activity. Imetelstat has been granted Fast Track designation by the United States 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. 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.

    Use of Forward-Looking Statements

    Except for the historical information contained herein, this press release contains forward-looking statements made pursuant to the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. Investors are cautioned that such statements, include, without limitation, those regarding: (i) imetelstat's potential to alter the course of MDS and MF; (ii) that imetelstat has potential disease-modifying activity; (iii) the potential of imetelstat to target the malignant stem and progenitor cells of the underlying disease; and (iv) other statements that are not historical facts, constitute forward-looking statements. These forward-looking statements involve risks and uncertainties that can cause actual results to differ materially from those in such forward-looking statements. These risks and uncertainties, include, without limitation, risks and uncertainties related to: (a) whether Geron overcomes all of the potential delays and other adverse impacts caused by the current or evolving effects of the COVID-19 pandemic, and overcomes all the enrollment, clinical, safety, efficacy, technical, scientific, intellectual property, manufacturing and regulatory challenges to complete its two Phase 3 clinical trials; (b) whether regulatory authorities permit the further development of imetelstat on a timely basis, or at all, without any clinical holds; (c) whether any future efficacy or safety results may cause the benefit-risk profile of imetelstat to become unacceptable; (d) whether imetelstat actually demonstrates disease-modifying activity in patients; and (e) whether imetelstat demonstrates that it targets the malignant stem and progenitor cells of the underlying disease in patients. Additional information on the above risks and uncertainties and additional risks, uncertainties and factors that could cause actual results to differ materially from those in the forward-looking statements are contained in Geron's filings and periodic reports filed with the Securities and Exchange Commission under the heading "Risk Factors" and elsewhere in such filings and reports, including Geron's quarterly report on Form 10-Q for the quarter ended March 31, 2021 and future filings and reports by Geron. Undue reliance should not be placed on forward-looking statements, which speak only as of the date they are made, and the facts and assumptions underlying the forward-looking statements may change. Except as required by law, Geron disclaims any obligation to update these forward-looking statements to reflect future information, events or circumstances.

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  4. Geron Corporation (NASDAQ:GERN), a late-stage clinical biopharmaceutical company, today announced that two poster presentations of new clinical data and analyses related to imetelstat, the Company's first-in-class telomerase inhibitor, will be made at the European Hematology Association (EHA) Annual Congress meeting to be held virtually from June 9 - 17. The abstracts for the posters are available on the EHA website at www.ehaweb.org. Both posters will be published on the EHA Virtual Congress platform on June 11, 2021.

    "We are pleased that the EHA accepted both of our abstracts which allows us to present what we believe to be imetelstat's compelling potential to become a leading treatment for lower risk MDS and MF patients," said Aleksandra…

    Geron Corporation (NASDAQ:GERN), a late-stage clinical biopharmaceutical company, today announced that two poster presentations of new clinical data and analyses related to imetelstat, the Company's first-in-class telomerase inhibitor, will be made at the European Hematology Association (EHA) Annual Congress meeting to be held virtually from June 9 - 17. The abstracts for the posters are available on the EHA website at www.ehaweb.org. Both posters will be published on the EHA Virtual Congress platform on June 11, 2021.

    "We are pleased that the EHA accepted both of our abstracts which allows us to present what we believe to be imetelstat's compelling potential to become a leading treatment for lower risk MDS and MF patients," said Aleksandra Rizo, M.D., Ph.D., Geron's Chief Medical Officer. "The new data and analyses from our Phase 2 IMbark and IMerge trials continue to highlight imetelstat's disease-modifying activity and potential to achieve remarkable clinical benefits, including durable transfusion independence in lower risk MDS patients and improvement in MF patients' overall survival. We look forward to the presentations and remain confident that imetelstat, with its unique telomerase inhibition mechanism of action, is a highly differentiated treatment that can positively impact patients."

    Abstract Title: Efficacy of Imetelstat is Independent of Molecular Subtypes in Heavily Transfused Non-Del(5q) Lower Risk MDS (LR-MDS) Relapsed/Refractory (R/R) to Erythropoiesis Stimulating Agents (ESA)

    Abstract Code: EP910

    The abstract reports new data and analyses of the clinical efficacy of imetelstat in molecularly defined patient subtypes from the IMerge Phase 2 clinical trial in transfusion dependent, non-del(5q) lower risk myelodysplastic syndromes (MDS) patients who are relapsed or refractory to ESAs. Clinical responses were analyzed across multiple molecularly defined subgroups based on cytogenetic and mutation profiles. The abstract concluded that imetelstat demonstrated clinical efficacy across different molecularly defined subgroups, including patients with poor prognosis.

    Abstract Title: Imetelstat Demonstrates an Acceptable Safety Profile in Myeloid Malignancies

    Abstract Code: EP1106

    The abstract describes new analyses of safety data from the Phase 2 IMbark and IMerge trials to further characterize hematologic and non-hematologic adverse events (AEs). Based on these analyses, the abstract concluded that imetelstat-related cytopenias observed in the trials were on-target effects based on the selective reduction of malignant cells through telomerase inhibition. Also, these cytopenias were of short duration, reversible and with limited clinical consequences when managed with the dose modification guidelines in the respective trial protocols. The difference in toxicity profiles between the two trials could be attributed to the different disease pathologies (proliferation vs. dysplasia) of patients with myelofibrosis or myelodysplastic syndromes.

    In accordance with EHA policies, abstracts submitted to the EHA Annual Congress are embargoed from the time of submission. To be eligible for presentation at the EHA Annual Congress, any additional data or information to be presented at the EHA Annual Congress may not be made public before the posters are published. The posters will be available on Geron's website at www.geron.com/r-d/publications after June 11, 2021.

    About Imetelstat

    Imetelstat is a novel, first-in-class telomerase inhibitor exclusively owned by Geron and being developed in hematologic myeloid malignancies. Data from Phase 2 clinical trials provide strong evidence that imetelstat targets telomerase to inhibit the uncontrolled proliferation of malignant stem and progenitor cells in hematologic myeloid malignancies resulting in malignant cell apoptosis and potential disease-modifying activity. Imetelstat has been granted Fast Track designation by the United States 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. 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.

    Use of Forward-Looking Statements

    Except for the historical information contained herein, this press release contains forward-looking statements made pursuant to the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. Investors are cautioned that such statements, include, without limitation, those regarding: (i) imetelstat's compelling potential to become a leading treatment for lower risk MDS and MF patients; (ii) imetelstat's potential to achieve remarkable clinical benefits, including durable transfusion independence in lower risk MDS patients and improvement in MF patients' overall survival; (iii) that imetelstat has potential disease-modifying activity; and (iv) other statements that are not historical facts, constitute forward-looking statements. These forward-looking statements involve risks and uncertainties that can cause actual results to differ materially from those in such forward-looking statements. These risks and uncertainties, include, without limitation, risks and uncertainties related to: (a) whether the current or evolving effects of the COVID-19 pandemic and resulting global economic and financial disruptions will materially and adversely impact Geron's business and business prospects, its financial condition and the future of imetelstat; (b) whether Geron overcomes all of the potential delays and other adverse impacts caused by the current or evolving effects of the COVID-19 pandemic, and overcomes all the enrollment, clinical, safety, efficacy, technical, scientific, intellectual property, manufacturing and regulatory challenges; (c) whether regulatory authorities permit the further development of imetelstat on a timely basis, or at all, without any clinical holds; (d) whether imetelstat is demonstrated to be safe and efficacious in the IMerge Phase 3 and IMpactMF clinical trials to enable regulatory approval; (e) whether any future efficacy or safety results may cause the benefit-risk profile of imetelstat to become unacceptable; (f) whether imetelstat actually demonstrates disease-modifying activity in patients; (g) whether there are failures or delays in manufacturing or supplying sufficient quantities of imetelstat or other clinical trial materials in a timely manner, whether due to the current or evolving effects of the COVID-19 pandemic or otherwise; and (h) whether imetelstat is able to maintain patent protection and have freedom to operate. Additional information on the above risks and uncertainties and additional risks, uncertainties and factors that could cause actual results to differ materially from those in the forward-looking statements are contained in Geron's filings and periodic reports filed with the Securities and Exchange Commission under the heading "Risk Factors" and elsewhere in such filings and reports, including Geron's quarterly report on Form 10-Q for the quarter ended March 31, 2021 and future filings and reports by Geron. Undue reliance should not be placed on forward-looking statements, which speak only as of the date they are made, and the facts and assumptions underlying the forward-looking statements may change. Except as required by law, Geron disclaims any obligation to update these forward-looking statements to reflect future information, events or circumstances.

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  5. IMerge Phase 3 Clinical Trial in Myelodysplastic Syndromes 75% Enrolled and On Track to Complete Enrollment in Second Half of 2021

    Two Abstracts Accepted by European Hematology Association for 2021 Virtual Congress

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

    Geron Corporation (NASDAQ:GERN), a late-stage clinical biopharmaceutical company developing a first-in-class telomerase inhibitor, imetelstat, to treat hematologic myeloid malignancies, today reported financial results for the first quarter ended March 31, 2021, as well as company highlights and upcoming events. As of March 31, 2021, the Company had $244.7 million in cash and marketable securities, which is expected to fund operations until the end of 2022.

    "We have worked diligently…

    IMerge Phase 3 Clinical Trial in Myelodysplastic Syndromes 75% Enrolled and On Track to Complete Enrollment in Second Half of 2021

    Two Abstracts Accepted by European Hematology Association for 2021 Virtual Congress

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

    Geron Corporation (NASDAQ:GERN), a late-stage clinical biopharmaceutical company developing a first-in-class telomerase inhibitor, imetelstat, to treat hematologic myeloid malignancies, today reported financial results for the first quarter ended March 31, 2021, as well as company highlights and upcoming events. As of March 31, 2021, the Company had $244.7 million in cash and marketable securities, which is expected to fund operations until the end of 2022.

    "We have worked diligently over the past quarter to advance our two Phase 3 clinical trials with registrational intent, and we remain laser focused on improving outcomes for patients and delivering significant value to our shareholders," said John A. Scarlett, M.D., Geron's Chairman and Chief Executive Officer.

    "Completing 75% of the planned enrollment in our MDS trial coupled with the recent dosing of the first patient in our MF trial indicate the continued progress we are making in our two Phase 3 clinical trials for imetelstat," said Aleksandra Rizo, M.D., Ph.D., Geron's Chief Medical Officer. "We continue to have confidence in imetelstat's differentiating clinical benefits seen throughout the course of its development, including strong evidence of disease-modifying activity. We're excited to have another opportunity to highlight imetelstat's strong data profile through the two abstracts accepted for presentation at the upcoming European Hematology Association meeting. We look forward to achieving top-line results from our IMerge Phase 3 study and the promising path ahead for imetelstat."

    Dr. Scarlett concluded, "We are excited about the progress we are making to bring this important drug to patients. We are planning for Geron to become a commercial company in 2023 with the potential launch of imetelstat in lower risk MDS. The markets for both lower risk MDS and refractory MF are highly attractive. We continue to make preparations and manage our cash appropriately to support the future buildout of our manufacturing and commercial infrastructure."

    Company Highlights and Upcoming Data Presentations

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

    Screening and enrollment for IMerge Phase 3 in MDS continued to progress in the first quarter. In early December 2020, the Company had completed 50% of the planned patient enrollment in IMerge Phase 3. As of the end of April 2021, enrollment has increased to 75%. The Company continues to expect the trial to be fully enrolled in the second half of 2021. Depending on the timing of full enrollment, the Company expects top-line results from IMerge Phase 3 to be available during the time period from the end of 2022 to the first half 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)

    On April 13, the Company announced that the first patient had been dosed in IMpactMF, the only Phase 3 clinical trial in MF with overall survival (OS) as a primary endpoint evaluating imetelstat, a first-in-class telomerase inhibitor. The Company plans to engage over 180 sites to participate in IMpactMF across North America, South America, Europe, Australia, and Asia. The Company continues to expect the interim analysis to occur in 2024 and the final analysis in 2025.

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

    Upcoming Data Presentations

    Two abstracts reporting new clinical data and analyses from the Phase 2 trials of imetelstat in lower risk MDS and refractory MF have been accepted for presentation at the European Hematology Association (EHA) Annual Congress meeting to be held virtually from June 9 – 17, 2021. Both of the abstracts will be published on May 12, 2021 at 16:00 CEST on ehaweb.org.

    First Quarter 2021 Results

    For the first quarter of 2021, the Company reported a net loss of $27.8 million, or $0.09 per share, compared to $16.4 million, or $0.08 per share, for the same period in 2020.

    Revenues for the first quarter of 2021 were $137,000 compared to $52,000 for the same period in 2020. Royalty 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 first quarter of 2021 were $28.6 million compared to $16.9 million for the same period in 2020. Research and development expenses for the first quarter of 2021 were $21.1 million compared to $10.8 million for the same period in 2020. The increase in research and development expenses in the first quarter of 2021 compared to the same period 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 first quarter of 2021 were $7.5 million compared to $6.1 million for the same period in 2020. The increase in general and administrative expenses in the first quarter of 2021 compared to the same period 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.

    Interest income for the first quarter of 2021 was $173,000 compared to $754,000 for the same period in 2020. The decrease in interest income in the first quarter of 2021 compared to the same period in 2020 primarily reflects lower yields on the Company's reduced marketable securities portfolio.

    Interest expense for the first quarter of 2021 was $743,000 and reflects the Company's debt facility secured in September 2020 for up to $75 million. Currently, $25.0 million has been drawn down under the facility.

    Net other income for the first quarter of 2021 was $1.2 million compared to net other expense of $44,000 for the same period in 2020. During the first quarter of 2021, the Company sold all of its holdings in an equity investment resulting in a net realized gain of $1.2 million, including foreign currency translation adjustments.

    2021 Financial Guidance Reaffirmed

    For fiscal year 2021, the Company continues to expect its operating expense burn to range from $108 to $112 million, which includes costs for the two ongoing Phase 3 clinical trials; producing validation batches of imetelstat at contract manufacturers to enable future production of imetelstat for clinical and commercial purposes; and preparatory activities for regulatory filings to enable drug approval and commercial readiness.

    As of March 31, 2021, the Company had 63 employees. The Company plans to grow to a total of approximately 80 to 85 employees by year-end 2021, of which the majority will be development and manufacturing personnel.

    Conference Call

    The Company will host a conference call today, May 10, 2021 at 4:30 p.m. ET to review its first quarter financial results and provide an update on the ongoing imetelstat Phase 3 clinical trials, IMerge in MDS and IMpactMF in MF.

    A live, listen-only webcast will be available on the Company's website at www.geron.com/investors/events. An archive of the webcast will be available on the Company's website for 30 days.

    Participants may access the conference call live via telephone by pre-registering online using the following link, http://www.directeventreg.com/registration/event/2456438. Upon registration, a phone number, Direct Event Passcode and unique Registrant ID will be sent via email. This information will be needed in order to enter the conference call. Participants are advised to pre-register at least 10 minutes prior to joining the call.

    About Imetelstat

    Imetelstat is a novel, first-in-class telomerase inhibitor exclusively owned by Geron and being developed in hematologic myeloid malignancies. Data from Phase 2 clinical trials provide strong evidence that imetelstat targets telomerase to inhibit the uncontrolled proliferation of malignant stem and progenitor cells in hematologic myeloid malignancies resulting in malignant cell apoptosis and potential disease-modifying activity. Imetelstat has been granted Fast Track designation by the United States 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 IMerge Phase 3

    IMerge Phase 3 is a double-blind, randomized, placebo-controlled Phase 3 clinical trial with registrational intent. The trial is designed to enroll approximately 170 transfusion dependent patients with Low or Intermediate-1 risk myelodysplastic syndromes (MDS), also referred to as lower risk MDS, who have relapsed after or are refractory to prior treatment with an erythropoiesis stimulating agent (ESA). The primary endpoint is the rate of red blood cell (RBC) transfusion independence (TI) for any consecutive period of eight weeks or longer, or 8-week RBC-TI rate. Key secondary endpoints include the rate of RBC-TI lasting at least 24 weeks, or 24-week RBC-TI rate, and the rate of hematologic improvement-erythroid (HI-E), defined as a reduction of at least four units of RBC transfusions over eight weeks compared with the prior RBC transfusion burden.

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

    About IMpactMF

    IMpactMF is an open label, randomized, controlled Phase 3 clinical trial with registrational intent. The trial is designed to enroll approximately 320 patients with Intermediate-2 or High-risk myelofibrosis who are refractory to prior treatment with a JAK inhibitor, also referred to as refractory MF. Patients will be randomized to receive either imetelstat or best available therapy. The primary endpoint is overall survival (OS). Key secondary endpoints include symptom response, spleen response, progression free survival, complete response, partial response, clinical improvement, duration of response, safety, pharmacokinetics, and patient reported outcomes.

    IMpactMF is currently enrolling patients. For further information about IMpactMF, including enrollment criteria, locations and current status, visit ClinicalTrials.gov/NCT04576156.

    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. 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.

    Use of Forward-Looking Statements

    Except for the historical information contained herein, this press release contains forward-looking statements made pursuant to the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. Investors are cautioned that such statements, include, without limitation, those regarding: (i) that Geron's two Phase 3 trials have registrational intent; (ii) that imetelstat has shown strong evidence of disease-modifying activity, meaning that imetelstat has the potential to demonstrate disease-modifying activity in patients; (iii) that Geron plans to engage over 180 sites for IMpactMF; (iv) that Geron plans to become a commercial company in 2023 with the potential launch of imetelstat in lower risk MDS; (v) that Geron expects IMerge Phase 3 to be fully enrolled in the second half of 2021; (vi) that Geron expects top-line results for IMerge Phase 3 to be available during the time period from the end of 2022 to the first half of 2023; (vii) that under current planning assumptions for IMpactMF, Geron expects to conduct an interim analysis in 2024 and a final analysis in 2025; (viii) that Geron's 2021 operating expense burn will range from $108 to $112 million; (ix) that Geron expects to grow to 80-85 employees in 2021; and (x) other statements that are not historical facts, constitute forward-looking statements. These forward-looking statements involve risks and uncertainties that can cause actual results to differ materially from those in such forward-looking statements. These risks and uncertainties, include, without limitation, risks and uncertainties related to: (a) whether the current or evolving effects of the COVID-19 pandemic and resulting global economic and financial disruptions will materially and adversely impact Geron's business and business prospects, its financial condition and the future of imetelstat; (b) whether Geron overcomes all of the potential delays and other adverse impacts caused by the current or evolving effects of the COVID-19 pandemic, and overcomes all the enrollment, clinical, safety, efficacy, technical, scientific, intellectual property, manufacturing and regulatory challenges in order to meet the expected timelines and planned milestones in (iii), (iv), (v), (vi) and (vii) above; (c) whether regulatory authorities permit the further development of imetelstat on a timely basis, or at all, without any clinical holds; (d) whether imetelstat is demonstrated to be safe and efficacious in IMerge Phase 3 and IMpactMF to enable regulatory approval; (e) whether any future efficacy or safety results may cause the benefit-risk profile of imetelstat to become unacceptable; (f) whether imetelstat actually demonstrates disease-modifying activity in patients; (g) that Geron will need to raise substantial capital in order to complete the development and commercialization of imetelstat, including to meet all of the expected timelines and planned milestones in (iii), (iv), (v), (vi) and (vii) above; (h) whether regulatory authorities require an additional clinical trial for approval even if IMerge Phase 3 or IMpactMF meet their respective primary endpoint(s); (i) whether there are failures or delays in manufacturing or supplying sufficient quantities of imetelstat or other clinical trial materials in a timely manner, whether due to the current or evolving effects of the COVID-19 pandemic or otherwise; (j) whether imetelstat is able to maintain patent protection and have freedom to operate; (k) whether there are cost overruns in 2021 due to the current or evolving effects of the COVID-19 pandemic or otherwise; (l) whether Geron can accurately project the timing of, or attain complete enrollment in IMerge Phase 3 or IMpactMF, whether due to the current or evolving effects of the COVID-19 pandemic or otherwise; and (m) whether Geron is able to enroll IMerge Phase 3 and IMpactMF at a pace that would enable meeting the timelines in (iv), (v), (vi) and (vii) above. Additional information on the above risks and uncertainties and additional risks, uncertainties and factors that could cause actual results to differ materially from those in the forward-looking statements are contained in Geron's filings and periodic reports filed with the Securities and Exchange Commission under the heading "Risk Factors" and elsewhere in such filings and reports, including Geron's quarterly report on Form 10-Q for the quarter ended March 31, 2021 and future filings and reports by Geron. Undue reliance should not be placed on forward-looking statements, which speak only as of the date they are made, and the facts and assumptions underlying the forward-looking statements may change. Except as required by law, Geron disclaims any obligation to update these forward-looking statements to reflect future information, events or circumstances.

    Financial table follows.

    GERON CORPORATION

    CONDENSED STATEMENTS OF OPERATIONS

     

     

     

    UNAUDITED

     

     

    Three Months Ended March 31,

    (In thousands, except share and per share data)

    2021

     

    2020

     

     

     

    Revenues:

     

     

    License fees and royalties

    $

    137

     

    $

    52

     

     

     

     

    Operating expenses:

     

     

    Research and development

     

    21,113

     

     

    10,802

     

    General and administrative

     

    7,478

     

     

    6,120

     

    Total operating expenses

     

    28,591

     

     

    16,922

     

    Loss from operations

     

    (28,454

    )

     

    (16,870

    )

     

     

     

    Interest income

     

    173

     

     

    754

     

    Interest expense

     

    (743

    )

     

     

    Change in fair value of equity investment

     

     

     

    (195

    )

    Other income and expense, net

     

    1,200

     

     

    (44

    )

    Net loss

    $

    (27,824

    )

    $

    (16,355

    )

     

     

     

    Basic and diluted net loss per share:

     

     

    Net loss per share

    $

    (0.09

    )

    $

    (0.08

    )

    Shares used in computing net loss per share

     

    323,638,696

     

     

    200,222,092

     

    CONDENSED BALANCE SHEETS

     

     

     

    March 31,

     

    December 31,

    (In thousands)

     

    2021

     

    2020

     

     

    (Unaudited)

     

    (Note 1)

    Current assets:

     

     

     

     

    Cash, cash equivalents and restricted cash

     

    $

    31,900

     

    $

    10,288

    Current marketable securities

     

     

    179,490

     

     

    186,350

    Other current assets

     

     

    3,874

     

     

    3,219

    Total current assets

     

     

    215,264

     

     

    199,857

     

     

     

     

     

    Noncurrent marketable securities

     

     

    33,289

     

     

    63,387

    Property and equipment, net

     

     

    620

     

     

    658

    Deposits and other assets

     

     

    9,435

     

     

    6,826

     

     

    $

    258,608

     

    $

    270,728

     

     

     

     

     

    Current liabilities

     

    $

    28,552

     

    $

    30,940

    Noncurrent liabilities

     

     

    28,894

     

     

    28,841

    Stockholders' equity

     

     

    201,162

     

     

    210,947

     

     

    $

    258,608

     

    $

    270,728

    Note 1: Derived from audited financial statements included in the Company's annual report on Form 10-K for the year ended December 31, 2020.

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