1. Geron Corporation (NASDAQ:GERN) today reported that it has granted a non-statutory stock option to purchase an aggregate of 400,000 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 September 15, 2021 at an exercise price of $1.36 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…

    Geron Corporation (NASDAQ:GERN) today reported that it has granted a non-statutory stock option to purchase an aggregate of 400,000 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 September 15, 2021 at an exercise price of $1.36 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 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. Geron Corporation (NASDAQ:GERN) today announced that John A. Scarlett, M.D., Geron's Chairman and Chief Executive Officer, is scheduled to present at the following investor conferences:

    • H.C. Wainwright 23rd Annual Global Virtual Investment Conference on Monday, September 13, 2021 at 7:00 a.m. ET.
    • R.W. Baird 2021 Virtual Global Healthcare Conference on Tuesday, September 14, 2021 at 2:00 p.m. ET.
    • 2021 Cantor Virtual Global Healthcare Conference on Thursday, September 30, 2021 at 3:20 p.m. ET.

    A live webcast of each presentation will be available through the Investor Relations section of Geron's website under Events. Following the presentations, the webcasts will be archived and available for replay for a period of 30 days.

    About Geron

    Geron Corporation (NASDAQ:GERN) today announced that John A. Scarlett, M.D., Geron's Chairman and Chief Executive Officer, is scheduled to present at the following investor conferences:

    • H.C. Wainwright 23rd Annual Global Virtual Investment Conference on Monday, September 13, 2021 at 7:00 a.m. ET.
    • R.W. Baird 2021 Virtual Global Healthcare Conference on Tuesday, September 14, 2021 at 2:00 p.m. ET.
    • 2021 Cantor Virtual Global Healthcare Conference on Thursday, September 30, 2021 at 3:20 p.m. ET.

    A live webcast of each presentation will be available through the Investor Relations section of Geron's website under Events. Following the presentations, the webcasts will be archived and available for replay for a period of 30 days.

    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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  3. Geron Corporation (NASDAQ:GERN) today reported that it has granted non-statutory stock options to purchase an aggregate of 550,000 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 August 18, 2021 at an exercise price of $1.25 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 550,000 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 August 18, 2021 at an exercise price of $1.25 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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  4. Completion of Enrollment in IMerge Phase 3 Expected in the Fourth Quarter of 2021

    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

    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…

    Completion of Enrollment in IMerge Phase 3 Expected in the Fourth Quarter of 2021

    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

    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.

    Interest income for the three and six months ended June 30, 2021 was $136,000 and $309,000, respectively, compared to $475,000 and $1.2 million for the comparable 2020 periods. The decrease in interest income for the three and six months ended June 30, 2021, compared to the same periods in 2020, primarily reflects lower yields on the Company's marketable securities portfolio.

    Interest expense for the three and six months ended June 30, 2021 was $804,000 and $1.5 million, respectively and reflects the Company's debt facility secured in September 2020 for up to $75 million. In June 2021, the Company completed a drawdown of $10.0 million in accordance with the loan agreement. Currently, a total of $35.0 million has been drawn down under the facility.

    Financial Resources

    Previously, the Company provided guidance that its financial resources were sufficient to fund its operations through the end of 2022. 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 now expected to fund operations through the end of the first quarter of 2023.

    As of June 30, 2021, the Company had 68 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

    Geron will host a conference call at 4:30 p.m. ET on Monday, August 16, 2021 to provide an update on the ongoing imetelstat Phase 3 clinical trials, IMerge in MDS and IMpactMF in MF, as well as discuss second quarter financial results.

    To view the Company's slide presentation and listen to the conference call live via webcast, visit the Company's website at www.geron.com/investors/events at the time of the conference call. An archive of the webcast will also 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/5548255. 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 expects IMerge Phase 3 to be fully enrolled in the fourth quarter of 2021; (ii) that Geron expects top-line results for IMerge Phase 3 to be available in the first quarter of 2023; (iii) that Geron expects to conduct an interim analysis for IMpactMF in 2024 and a final analysis in 2025; (iv) that Geron expects its financial resources, with the expected non-dilutive funding under the current debt facility, to fund operations through the end of the first quarter of 2023; (v) that Geron expects to grow to 80-85 employees in 2021; (vi) that Geron plans to engage over 180 sites for IMpactMF; (vii) that IMerge Phase 3 and IMpactMF have registrational intent; (viii) that imetelstat has the potential to demonstrate disease-modifying activity in patients and to target the malignant stem and progenitor cells of the underlying disease; (ix) that the Company expects imetelstat to be a highly differentiated product in the lower risk MDS commercial marketplace; (x) that the Company expects that the shortened 12-month follow-up period will still provide a sufficiently mature data set to assess the benefit-risk profile of imetelstat; and (xi) 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 have the financial resources for, and to meet the expected timelines and planned milestones in (i) through (vi) 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 and the ability to target the malignant stem and progenitor cells of the underlying disease; (g) that Geron may seek 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 (i) through (vi) above; (h) whether regulatory authorities require an additional clinical trial for approval even if IMerge Phase 3 or IMpactMF meet their respective primary endpoints; (i) whether there are failures or delays in manufacturing or supplying sufficient quantities of imetelstat or other clinical trial materials in a timely manner; (j) whether imetelstat is able to maintain patent protection and have freedom to operate; (k) whether the shortened follow-up period of 12 months for the IMerge Phase 3 primary analysis results in not obtaining sufficient data to demonstrate safety and efficacy, including transfusion independence, of imetelstat to support any application for regulatory approval; (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 the financial resources for, and to meet the expected timelines and planned milestones in (i) through (vi) 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 June 30, 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

    Six Months Ended

     

    June 30,

    June 30,

    (In thousands, except share and per share data)

    2021

     

    2020

     

    2021

     

    2020

     

     

     

     

     

     

    Revenues:

     

     

     

     

    License fees and royalties

    $

    107

     

    $

    43

     

    $

    244

     

    $

    95

     

     

     

     

     

     

     

     

     

     

    Operating expenses:

     

     

     

     

     

     

     

     

    Research and development

     

    21,937

     

     

    10,845

     

     

    43,050

     

     

    21,647

     

    General and administrative

     

    7,059

     

     

    5,960

     

     

    14,537

     

     

    12,080

     

    Total operating expenses

     

    28,996

     

     

    16,805

     

     

    57,587

     

     

    33,727

     

    Loss from operations

     

    (28,889

    )

     

    (16,762

    )

     

    (57,343

    )

     

    (33,632

    )

     

     

     

     

     

     

     

     

     

    Interest income

     

    136

     

     

    475

     

     

    309

     

     

    1,229

     

    Interest expense

     

    (804

    )

     

     

     

    (1,547

    )

     

     

    Change in fair value of equity investment.

     

     

     

    422

     

     

     

     

    227

     

    Other income and expense, net

     

    (17

    )

     

    41

     

     

    1,183

     

     

    (3

    )

    Net loss

    $

    (29,574

    )

    $

    (15,824

    )

    $

    (57,398

    )

    $

    (32,179

    )

     

     

     

     

     

     

     

     

     

    Basic and diluted net loss per share:

     

     

     

     

     

     

     

     

    Net loss per share

    $

    (0.09

    )

    $

    (0.06

    )

    $

    (0.18

    )

    $

    (0.14

    )

    Shares used in computing net loss per share

     

    327,026,907

     

     

    246,966,143

     

     

    325,342,161

     

     

    223,594,118

     

     

     

     

     

     

     

     

     

     

    CONDENSED BALANCE SHEETS

     

     

    June 30,

    December 31,

    (In thousands)

    2021

    2020

     

    (Unaudited)

    (Note 1)

    Current assets:

     

     

    Cash, cash equivalents and restricted cash

    $ 57,645

    $ 10,288

    Current marketable securities

    140,959

    186,350

    Other current assets

    3,158

    3,219

    Total current assets

    201,762

    199,857

     

     

     

    Noncurrent marketable securities

    40,521

    63,387

    Property and equipment, net

    590

    658

    Other assets

    9,302

    6,826

     

    $ 252,175

    $ 270,728

     

     

     

    Current liabilities

    $ 37,013

    $ 30,940

    Noncurrent liabilities

    38,956

    28,841

    Stockholders' equity

    176,206

    210,947

     

    $ 252,175

    $ 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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  5. Geron Corporation (NASDAQ:GERN) today announced that it will release its second quarter and year to date 2021 financial results after the market closes on Monday, August 16, 2021 via press release, which will be available on the Company's website at www.geron.com/investors. Geron will host a conference call to discuss the financial results as well as recent events at 4:30 p.m. ET the same day.

    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/5548255

    Geron Corporation (NASDAQ:GERN) today announced that it will release its second quarter and year to date 2021 financial results after the market closes on Monday, August 16, 2021 via press release, which will be available on the Company's website at www.geron.com/investors. Geron will host a conference call to discuss the financial results as well as recent events at 4:30 p.m. ET the same day.

    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/5548255. 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 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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  6. 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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  7. 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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  8. 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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  9. 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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  10. 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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  11. Geron Corporation (NASDAQ:GERN) today announced that it will release its first quarter 2021 financial results after the market closes on Monday, May 10, 2021 via press release, which will be available on the Company's website at www.geron.com/investors. Geron will host a conference call to discuss the financial results as well as recent events at 4:30 p.m. ET the same day.

    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…

    Geron Corporation (NASDAQ:GERN) today announced that it will release its first quarter 2021 financial results after the market closes on Monday, May 10, 2021 via press release, which will be available on the Company's website at www.geron.com/investors. Geron will host a conference call to discuss the financial results as well as recent events at 4:30 p.m. ET the same day.

    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 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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  12. Geron Corporation (NASDAQ:GERN) today reported that it has granted non-statutory stock options to purchase an aggregate of 220,000 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 April 21, 2021 at an exercise price of $1.48 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 220,000 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 April 21, 2021 at an exercise price of $1.48 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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  13. Geron Corporation (NASDAQ:GERN) today announced that the first patient has been dosed in IMpactMF, the Phase 3 clinical trial evaluating imetelstat, a first-in-class telomerase inhibitor, in refractory myelofibrosis (MF).

    "As the only study in refractory MF with overall survival as the primary endpoint, dosing of the first patient in IMpactMF is an important step in developing imetelstat as a potential treatment for these patients," said Aleksandra Rizo, M.D., Ph.D., Geron's Chief Medical Officer. "With a median overall survival of only approximately 14 – 16 months for patients who fail or no longer respond to JAK inhibitor treatment, there is a significant unmet medical need for therapies that will improve survival."

    IMpactMF is an open…

    Geron Corporation (NASDAQ:GERN) today announced that the first patient has been dosed in IMpactMF, the Phase 3 clinical trial evaluating imetelstat, a first-in-class telomerase inhibitor, in refractory myelofibrosis (MF).

    "As the only study in refractory MF with overall survival as the primary endpoint, dosing of the first patient in IMpactMF is an important step in developing imetelstat as a potential treatment for these patients," said Aleksandra Rizo, M.D., Ph.D., Geron's Chief Medical Officer. "With a median overall survival of only approximately 14 – 16 months for patients who fail or no longer respond to JAK inhibitor treatment, there is a significant unmet medical need for therapies that will improve survival."

    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.

    The final analysis for OS is planned to be conducted after more than 50% of the patients planned to be enrolled in the trial have died (referred to as an event). An interim analysis of OS is planned to be conducted after approximately 70% of the total projected number of events for the final analysis have occurred. Under current planning assumptions, the Company expects the interim analysis for IMpactMF to occur in 2024 and the final analysis in 2025. Because these analyses are event-driven, the results may be available at different times than currently expected.

    IMpactMF is currently enrolling patients. The Company plans to engage over 180 sites to participate in IMpactMF across North America, South America, Europe, Australia and Asia. For further information about IMpactMF, including enrollment criteria, locations and current status, visit ClinicalTrials.gov/NCT04576156.

    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) that imetelstat has potential disease-modifying activity; (ii) that Geron plans to engage over 180 sites for IMpactMF; (iii) that under current planning assumptions for IMpactMF, Geron expects to conduct an interim analysis in 2024 and a final analysis in 2025; (iv) that the final analysis for OS is planned to be conducted after more than 50% of the patients planned to be enrolled in the trial have died (i.e., an event) and that an interim analysis of OS is planned to be conducted after approximately 70% of the total projected number of events for the final analysis have occurred; and (v) 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 (ii), (iii) and (iv) above; (c) whether regulatory authorities permit the further development of imetelstat on a timely basis, or at all, without any clinical holds; (d) whether any future efficacy or safety results may cause the benefit-risk profile of imetelstat to become unacceptable; (e) whether imetelstat actually demonstrates disease-modifying activity in patients; (f) 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 (ii), (iii) and (iv) above; (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 Geron is able to enroll IMpactMF at a pace that would enable an interim analysis in 2024 and a final analysis in 2025. 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 annual report on Form 10-K for the year ended December 31, 2020 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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  14. Geron Corporation (NASDAQ:GERN) today reported that it has granted non-statutory stock options to purchase an aggregate of 240,000 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 March 17, 2021 at an exercise price of $1.81 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 240,000 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 March 17, 2021 at an exercise price of $1.81 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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  15. 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 fourth quarter and year ended December 31, 2020. The Company ended fiscal year 2020 with $260 million in cash and marketable securities, which is expected to fund operations until the end of 2022.

    "Geron's vision is to be recognized as a leader in the treatment of hematologic malignancies by changing the course of these diseases and thereby improving and extending the lives of patients," said John A. Scarlett, M.D., Chairman and Chief Executive Officer. "In 2020, we made…

    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 fourth quarter and year ended December 31, 2020. The Company ended fiscal year 2020 with $260 million in cash and marketable securities, which is expected to fund operations until the end of 2022.

    "Geron's vision is to be recognized as a leader in the treatment of hematologic malignancies by changing the course of these diseases and thereby improving and extending the lives of patients," said John A. Scarlett, M.D., Chairman and Chief Executive Officer. "In 2020, we made important progress toward realizing that vision through two ongoing Phase 3 clinical trials, presentation of new data and analyses providing strong evidence of imetelstat's disease-modifying potential that differentiates imetelstat from other treatments today, and raising the capital necessary to support future activities. With this momentum from 2020, in 2021, we plan to complete enrollment in IMerge Phase 3, advance site initiation and enrollment in IMpactMF, and begin activities to prepare for Geron's first NDA filing and potential commercial launch. With a strong team in place and the financial resources to support these plans, we believe our vision can be attained."

    Dr. Scarlett added, "We are hopeful that clinical site operations will normalize in the next several months since vaccine distribution has commenced in many countries and the number of COVID-19 cases is declining. However, the fluid and dynamic nature of the pandemic continues to create uncertainty and unpredictability on our clinical trial activities. Taking into account these challenges and under current planning assumptions, we expect IMerge Phase 3 to be fully enrolled in the second half of 2021. Depending on the timing of full enrollment, we expect top-line results from IMerge Phase 3 to be available from the end of 2022 to the first half of 2023. For IMpactMF, under current planning assumptions, we expect the pace of enrollment to be slower and now project the event-driven analyses for the trial to occur in 2024 for the interim analysis and 2025 for the final analysis."

    Company Highlights and Upcoming Milestones

    Ongoing Phase 3 Clinical Trials

    IMerge in Lower Risk Myelodysplastic Syndromes (MDS)

    In December 2020, 50% of the planned enrollment in IMerge was achieved and today, 65% have been enrolled. In the fourth quarter of 2020, the first meeting of the Independent Data Monitoring Committee (IDMC) was held, and the IDMC recommended that the trial continue without modification.

    In the past few winter months, the resurgence of COVID-19 cases caused delays in clinical site openings, as well as patient screening and enrollment, and such delays may be ameliorated with broader vaccine distribution and other public health safety measures. With the current decline in the number of COVID-19 cases, the Company expects its trial operations to begin to normalize in the next several months. However, the pace at which any normalization may occur remains uncertain and unpredictable. Taking into account these dynamic and evolving circumstances, under current planning assumptions, the Company expects IMerge Phase 3 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 first half of 2023. To address the delays in enrollment, the Company continues to pursue enrollment boosting activities, including opening new sites, engaging clinical science liaisons and employing a social media campaign. Currently, 105 sites are open for enrollment, and the Company expects to open the remaining 15 additional planned sites over the next few months.

    IMpactMF in Refractory Myelofibrosis (MF)

    IMpactMF, the only Phase 3 clinical trial in MF with overall survival (OS) as a primary endpoint, opened for screening and enrollment in December 2020 with three clinical sites in the United States. However, as with IMerge Phase 3, COVID-19 has negatively impacted clinical trial activities. In addition, in 2020 a number of competing trials were initiated in MF and other oncology indications in the countries where IMpactMF is planned to be conducted. As a result of these factors, site personnel resources are constrained at many clinical sites, causing delays in site initiation activities. Although the Company has expanded the number of countries and sites planned to conduct the trial, the Company now expects IMpactMF to be fully enrolled in 2024. The Company currently plans to engage over 180 sites to participate in IMpactMF across North America, South America, Europe, Australia and Asia.

    Under current planning assumptions around enrollment and median overall survival for each treatment arm, the Company expects to conduct the interim analysis in 2024 and the final analysis in 2025. The final analysis for OS is planned to be conducted after more than 50% of the patients enrolled in the trial have died. An interim analysis of OS is planned to be conducted after approximately 70% of the total projected number of events for the final analysis have occurred. If the pre-specified, statistically significant difference in OS between the two treatment arms is met at the interim analysis, it is possible that data from the interim analysis could support a registration filing. Both the planned interim and final analyses are event-driven and could occur on different timelines than currently expected.

    New Drug Application (NDA) and Commercial Readiness Activities in 2021

    The Company has begun preparations for the future submission of an NDA for imetelstat in lower risk MDS. Assuming the results of IMerge Phase 3 are supportive, the Company plans to submit the completed NDA in 2023.

    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.

    Presentations and Publications of Phase 2 Data and Analyses

    More Mature Clinical Data from IMerge Phase 2 Continue to Differentiate Imetelstat in Lower Risk MDS

    In October 2020, more mature data of 38 patients in IMerge Phase 2 were published in the Journal of Clinical Oncology (JCO) highlighting the durability of transfusion independence achievable with imetelstat treatment in the trial. Durability of transfusion independence continues to differentiate imetelstat with 29% (11/38) of patients being transfusion-free for more than one year, and a median duration of transfusion independence of 20 months. Such durability provides significant and meaningful clinical benefit to lower risk MDS patients given their chronic anemia. In addition, the JCO publication reported observations from the IMerge Phase 2 of depletion of cytogenetic abnormalities and reductions in key driver mutations for lower risk MDS which provide strong evidence of disease-modifying activity of imetelstat. These observations were further strengthened through the correlation of molecular data with clinical benefits of transfusion independence.

    The data from the JCO publication were also reported in an oral presentation at the American Society of Hematology (ASH) Annual Meeting in December 2020. Further analyses of IMerge Phase 2 data are expected to be presented at medical conferences in 2021.

    New Analyses of IMbark Phase 2 Data Support OS Outcome and Disease-Modifying Potential of Imetelstat

    In December 2020, new analyses of IMbark Phase 2 data were reported in oral and poster presentations at the ASH Annual Meeting. These analyses described dose-related improvements in OS that were correlated to other clinical benefits, such as symptom response and spleen volume reduction, which support previously reported improvement in OS for MF patients in the trial. Furthermore, (i) reductions in the variant allele frequency of key driver mutations in MF, indicating imetelstat targets the underlying malignant clone, and (ii) improvements in bone marrow fibrosis were correlated to improvement in OS, which provide further evidence of imetelstat's disease-modifying potential.

    Fourth Quarter and Full Year 2020 Results

    For the fourth quarter of 2020, the Company reported a net loss of $23.8 million, or $0.07 per share, compared to $29.1 million, or $0.15 per share, for the fourth quarter of 2019. Net loss for the full year of 2020 was $75.6 million, or $0.28 per share, compared to $68.5 million, or $0.36 per share, for the full year of 2019.

    Revenues for the three and twelve months ended December 31, 2020 were $50,000 and $253,000, respectively, compared to $171,000 and $460,000 for the same periods in 2019. Revenues in 2020 and 2019 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 former intellectual property.

    Total operating expenses for the three and twelve months ended December 31, 2020 were $23.3 million and $77.2 million, respectively, compared to $30.2 million and $73.0 million for the same periods in 2019. Research and development expenses for the three and twelve months ended December 31, 2020 were $16.2 million and $51.5 million, respectively, compared to $24.9 million and $52.1 million for the same periods in 2019. The overall decrease in research and development expenses, compared to the same periods in 2019, primarily reflects the net result of closing of the IMbark Phase 2 clinical trial, completion of the transition of the imetelstat program and reduced purchases of raw materials, drug substance and drug product, partially offset by increased costs for IMerge Phase 3 and start-up costs for IMpactMF. General and administrative expenses for the three and twelve months ended December 31, 2020 were $7.1 million and $25.7 million, respectively, compared to $5.3 million and $20.9 million, for the same periods in 2019. The overall increase in general and administrative expenses, compared to the same periods in 2019, primarily reflects increased personnel-related expenses for additional general and administrative headcount to support the development organization and higher legal costs.

    Interest income for the three and twelve months ended December 31, 2020 was $243,000 and $1.8 million, respectively, compared to $925,000 and $4.2 million for the same periods in 2019. The overall decrease in interest income, compared to the same periods in 2019, primarily reflects lower yields on the Company's marketable securities portfolio due to declining interest rates.

    Interest expense for the three and twelve months ended December 31, 2020 was $754,000 and $760,000, respectively. In September 2020, the Company secured a new debt facility for up to $75 million.

    The Company ended the 2020 fiscal year with $260 million in cash and marketable securities, which the Company believes is sufficient for its operations until the end of 2022.

    Projected 2021 Financial Guidance

    For fiscal year 2021, the Company expects 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 NDA and commercial readiness.

    As of December 31, 2020, the Company had 55 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 research and development personnel.

    Conference Call

    Geron will host a conference call at 4:30 p.m. ET on Thursday, March 11, 2021 to discuss fourth quarter and full year 2020 financial results and recent events.

    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/3329959. 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 imetelstat has potential disease-modifying activity; (ii) that Geron's current financial resources of $260 million in cash and marketable securities are expected to fund its operations until the end of 2022; (iii) that Geron plans to engage over 180 sites for IMpactMF; (iv) that Geron expects to submit the completed NDA for lower risk MDS in 2023, and assuming FDA approval of the NDA, forecasts a commercial launch of imetelstat in the United States in 2024; (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 will be available from the end of 2022 to first half of 2023; (vii) that the ten remaining additional IMerge Phase 3 sites will be open for screening and enrollment over the next few months; (viii) the possibility that data from the IMpactMF interim analysis could support a registration filing; (ix) that under current planning assumptions for IMpactMF, Geron projects and expects enrollment to be complete in 2024, to conduct an interim analysis in 2024 and a final analysis in 2025; (x) that Geron's 2021 operating expense burn will range from $108 to $112 million; (xi) that Geron expects to grow to 80-85 employees in 2021; (xii) that Geron expects to present further analyses of IMerge Phase 2 at medical conferences in 2021; and (xiii) 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), (vii) and (ix) 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 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) 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), (vi) and (ix) 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 IMpactMF at a pace that would enable an interim analysis in 2024 and a final analysis in 2025. 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 annual report on Form 10-K for the year ended December 31, 2020 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

    Year Ended

     

     

    December 31,

    December 31,

    (In thousands, except share and per share data)

     

    2020

    2019

    2020

    2019

     

     

     

     

     

     

    Revenues:

     

     

     

     

     

    License fees and royalties

     

    $

    50

    $

    171

    $

    253

    $

    460

     

     

     

     

     

     

     

     

     

     

    Operating expenses:

     

     

     

     

     

     

     

     

     

    Research and development

     

     

    16,228

     

    24,923

     

    51,488

     

    52,072

    General and administrative

     

     

    7,088

     

    5,256

     

    25,678

     

    20,893

    Total operating expenses

     

     

    23,316

     

    30,179

     

    77,166

     

    72,965

    Loss from operations

     

     

    (23,266)

     

    (30,008)

     

    (76,913)

     

    (72,505)

     

     

     

     

     

     

     

     

     

     

    Interest income

     

     

    243

     

    925

     

    1,828

     

    4,221

    Interest expense

     

     

    (754)

     

     

    (760)

     

    Change in fair value of equity investment.

     

     

    (49)

     

     

    60

     

    (195)

    Other income and (expense), net

     

     

    39

     

    13

     

    168

     

    (69)

    Net loss

     

    $

    (23,787)

    $

    (29,070)

    $

    (75,617)

    $

    (68,548)

     

     

     

     

     

     

     

     

     

     

    Basic and diluted net loss per share:

     

     

     

     

     

     

     

     

     

    Net loss per share

     

    $

    (0.07)

    $

    (0.15)

    $

    (0.28)

    $

    (0.36)

    Shares used in computing net loss per share

     

     

    318,813,084

     

    198,447,315

     

    271,460,265

     

    190,160,311

    CONDENSED BALANCE SHEETS

     

     

    December 31,

    December 31,

    (In thousands)

     

    2020

    2019

     

     

     

     

    Current assets:

     

     

     

    Cash, cash equivalents and restricted cash

     

    $

    10,288

    $

    13,914

    Current marketable securities

     

     

    186,350

     

    125,681

    Other current assets

     

     

    3,219

     

    2,013

    Total current assets

     

     

    199,857

     

    141,608

     

     

     

     

    Noncurrent marketable securities

     

     

    63,387

     

    19,651

    Property and equipment, net

     

     

    658

     

    408

    Other assets

     

     

    6,826

     

    3,850

     

     

    $

    270,728

    $

    165,517

     

     

     

     

    Current liabilities

     

    $

    30,940

    $

    28,162

    Noncurrent liabilities

     

     

    28,841

     

    2,200

    Stockholders' equity

     

     

    210,947

     

    135,155

     

     

    $

    270,728

    $

    165,517

     

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  16. Geron Corporation (NASDAQ:GERN) today announced that it will release its fourth quarter and full year 2020 financial results after the market closes on Thursday, March 11, 2021 via press release, which will be available on the Company's website at www.geron.com/investors. Geron will host a conference call to discuss the financial results as well as recent events at 4:30 p.m. ET the same day.

    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/3329959

    Geron Corporation (NASDAQ:GERN) today announced that it will release its fourth quarter and full year 2020 financial results after the market closes on Thursday, March 11, 2021 via press release, which will be available on the Company's website at www.geron.com/investors. Geron will host a conference call to discuss the financial results as well as recent events at 4:30 p.m. ET the same day.

    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/3329959. 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 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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  17. Geron Corporation (NASDAQ:GERN) today reported that it has granted non-statutory stock options to purchase an aggregate of 431,600 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 February 17, 2021 at an exercise price of $1.99 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…

    Geron Corporation (NASDAQ:GERN) today reported that it has granted non-statutory stock options to purchase an aggregate of 431,600 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 February 17, 2021 at an exercise price of $1.99 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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  18. Geron Corporation (NASDAQ:GERN) today reported that it has granted non-statutory stock options to purchase an aggregate of 120,000 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 January 20, 2021 at an exercise price of $1.74 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 120,000 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 January 20, 2021 at an exercise price of $1.74 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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  19. Geron Corporation (NASDAQ:GERN), a late-stage clinical biopharmaceutical company, today announced that John A. Scarlett, M.D., Chairman and Chief Executive Officer, will present a company overview at the B. Riley Securities Virtual Oncology Investor Conference on Wednesday, January 20, at 3:00 p.m. ET.

    A live audio webcast of the presentation will be available on Geron's website, www.geron.com/investors/events. A replay of the webcast will be available on the Company's website for 30 days.

    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…

    Geron Corporation (NASDAQ:GERN), a late-stage clinical biopharmaceutical company, today announced that John A. Scarlett, M.D., Chairman and Chief Executive Officer, will present a company overview at the B. Riley Securities Virtual Oncology Investor Conference on Wednesday, January 20, at 3:00 p.m. ET.

    A live audio webcast of the presentation will be available on Geron's website, www.geron.com/investors/events. A replay of the webcast will be available on the Company's website for 30 days.

    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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  20. Geron Corporation (NASDAQ:GERN), a late-stage clinical biopharmaceutical company, today announced the opening for patient screening and enrollment of the IMpactMF Phase 3 clinical trial of imetelstat, a first-in-class telomerase inhibitor, in refractory myelofibrosis (MF).

    "As Geron's second registration-enabling Phase 3 trial in hematologic myeloid malignancies, the IMpactMF trial represents a milestone for our Company," said Aleksandra Rizo, M.D., Ph.D., Geron's Chief Medical Officer. "The IMpactMF trial will evaluate imetelstat in a poor-prognosis refractory MF patient population to confirm the clinical benefits of extended overall survival and symptom improvement observed in our IMbark Phase 2 trial, as well as the reductions in abnormal…

    Geron Corporation (NASDAQ:GERN), a late-stage clinical biopharmaceutical company, today announced the opening for patient screening and enrollment of the IMpactMF Phase 3 clinical trial of imetelstat, a first-in-class telomerase inhibitor, in refractory myelofibrosis (MF).

    "As Geron's second registration-enabling Phase 3 trial in hematologic myeloid malignancies, the IMpactMF trial represents a milestone for our Company," said Aleksandra Rizo, M.D., Ph.D., Geron's Chief Medical Officer. "The IMpactMF trial will evaluate imetelstat in a poor-prognosis refractory MF patient population to confirm the clinical benefits of extended overall survival and symptom improvement observed in our IMbark Phase 2 trial, as well as the reductions in abnormal clones and mutation burden demonstrating disease-modifying activity of imetelstat."

    Geron plans for IMpactMF to evaluate imetelstat compared to best available therapy (BAT) in approximately 320 patients with Intermediate-2 or High-risk MF. Patients eligible for the trial will be required to be non-responsive, or refractory, to treatment with a JAK inhibitor. The primary efficacy endpoint for the Phase 3 trial is overall survival (OS). Secondary endpoints include symptom response, spleen response, progression free survival, duration of response, safety, pharmacokinetics and patient reported outcomes. Geron plans to engage over 150 sites to participate in IMpactMF across North America, South America, Europe and Asia, with the majority of clinical sites expected to be open for screening and enrollment in 2021, subject to potential delays or interruptions associated with the evolving and uncertain effects of the COVID-19 pandemic.

    To learn more about IMpactMF and whether the study is enrolling patients in your area, please visit www.clinicaltrials.gov.

    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. Currently, MF patients who fail or no longer respond to JAK inhibitor 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. Phase 2 clinical data strongly suggest that imetelstat has disease-modifying activity through the apoptosis of malignant stem and progenitor cells, which allows potential recovery of normal hematopoiesis. Geron is currently conducting two registration-enabling Phase 3 clinical trials of imetelstat: IMerge, a Phase 2/3 trial in lower risk myelodysplastic syndromes (MDS), and IMpactMF, a Phase 3 trial in refractory myelofibrosis (MF). 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. 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 plans to enroll approximately 320 patients and engage over 150 sites to participate in IMpactMF, and expects the majority of such clinical sites to be open for screening and enrollment in 2021; (ii) that clinical data strongly suggest imetelstat has disease-modifying activity; 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: (i) whether the Company is able to overcome all the clinical, safety, efficacy, operational, technical, scientific, intellectual property, manufacturing and regulatory challenges to enable approximately 320 patients to be enrolled and for over 150 medical centers globally to participate in IMpactMF; (ii) whether regulatory authorities permit the further development and commercialization of imetelstat on a timely basis, or at all, without any clinical holds; (iii) whether imetelstat is demonstrated to be safe and efficacious in IMpactMF and other clinical trials; (iv) whether any future efficacy or safety results may cause the benefit-risk profile of imetelstat to become unacceptable; (v) whether imetelstat actually demonstrates disease-modifying activity in patients; (vi) whether the Company maintains sufficient funding to complete IMpactMF; (vii) whether Geron overcomes all the potential delays, added expense and other adverse impacts caused by the continuing and evolving effects of the novel coronavirus (COVID-19) pandemic; and (viii) 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 September 30, 2020. 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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  21. IMerge Phase 3 enrollment completion expected in second quarter of 2021

    Top-line results expected in second half of 2022

    Geron Corporation (NASDAQ:GERN), a late-stage clinical biopharmaceutical company, today announced achievement of fifty percent enrollment in the IMerge Phase 3 clinical trial of imetelstat in lower risk myelodysplastic syndromes (MDS). Data from the IMerge Phase 2 were recently presented at the American Society of Hematology Annual Meeting and support the ongoing Phase 3.

    "Reaching fifty percent enrollment is a key milestone towards the completion of this registration-enabling Phase 3 clinical trial, and we appreciate all of the support from our investigators and the patients who are participating in this study," said…

    IMerge Phase 3 enrollment completion expected in second quarter of 2021

    Top-line results expected in second half of 2022

    Geron Corporation (NASDAQ:GERN), a late-stage clinical biopharmaceutical company, today announced achievement of fifty percent enrollment in the IMerge Phase 3 clinical trial of imetelstat in lower risk myelodysplastic syndromes (MDS). Data from the IMerge Phase 2 were recently presented at the American Society of Hematology Annual Meeting and support the ongoing Phase 3.

    "Reaching fifty percent enrollment is a key milestone towards the completion of this registration-enabling Phase 3 clinical trial, and we appreciate all of the support from our investigators and the patients who are participating in this study," said Aleksandra Rizo, M.D., Ph.D., Geron's Chief Medical Officer. "We believe that the IMerge Phase 3 will confirm the meaningful and durable transfusion independence and the disease-modifying activity of imetelstat observed from the Phase 2, and that imetelstat could become a much-needed treatment alternative for patients with lower risk MDS."

    The IMerge Phase 3 is a double-blind, randomized, placebo-controlled clinical trial with registration intent. The trial is designed to enroll approximately 170 transfusion dependent patients with Low or Intermediate-1 risk MDS, or 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 a consecutive period of eight weeks or longer, or 8-week RBC-TI rate. Key secondary endpoints include the rate of RBC-TI of at least 24 weeks, or 24-week RBC-TI rate, 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, and duration of transfusion independence.

    The Company continues to expect full enrollment in the IMerge Phase 3 in the second quarter of 2021. As long as enrollment is completed by the end of the first half of 2021, Geron maintains its projection of top-line results from IMerge to be available in the second half of 2022.

    To learn more about IMerge and whether the study is enrolling patients in your area, please visit www.clinicaltrials.gov.

    About Myelodysplastic Syndromes (MDS)

    Myelodysplastic syndromes 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 blood production. There are approximately 60,000 people in the United States living with the disease and approximately 16,000 reported new cases of MDS in the United States every year. The majority of patients, approximately 70%, fall into the lower risk groups at diagnosis, according to the International Prognostic Scoring System that takes into account the presence of a number of disease factors, such as cytopenias and cytogenetics, to assign relative risk of progression to acute myeloid leukemia (AML) and overall survival.

    Chronic anemia is the predominant clinical problem in patients who have lower risk MDS. Due to low hemoglobin, many of these patients become dependent on red blood cell transfusions which can lead to iron overload, higher risk of development AML and poorer overall survival. Currently, no drug therapy has been shown prospectively to alter or delay disease progression.

    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 strongly suggest that imetelstat has disease-modifying activity through the apoptosis of malignant stem and progenitor cells, which allows potential recovery of normal hematopoiesis. Current clinical studies of imetelstat include IMerge, an ongoing Phase 2/3 trial in lower risk myelodysplastic syndromes (MDS), and IMpactMF, an upcoming Phase 3 clinical trial in refractory myelofibrosis (MF). 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. 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 expects enrollment completion in the IMerge Phase 3 trial in the second quarter of 2021 and that top-line results for the IMerge Phase 3 trial to be available in the second half of 2022, as long as enrollment is completed by the end of the first half of 2021; (ii) that the IMerge Phase 3 trial will confirm the meaningful and durable transfusion independence and disease-modifying activity of imetelstat observed in the Phase 2; (iii) that clinical data strongly suggest that imetelstat has disease-modifying activity; (iv) that imetelstat may potentially be commercialized and become a treatment alternative for patients with lower risk MDS; and (v) 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: (i) whether the Company is able to overcome all the clinical, safety, efficacy, operational, technical, scientific, intellectual property, manufacturing and regulatory challenges to enable: (a) 170 patients to be enrolled in the IMerge Phase 3 and (b) the eventual commercialization of imetelstat; (ii) whether regulatory authorities permit the further development and commercialization of imetelstat on a timely basis, or at all, without any clinical holds; (iii) whether imetelstat is demonstrated to be safe and efficacious in the IMerge Phase 3 clinical trial and other clinical trials; (iv) whether any future efficacy or safety results may cause the benefit-risk profile of imetelstat to become unacceptable; (v) whether imetelstat actually demonstrates disease-modifying activity in patients; (vi) whether the Company is able to complete full study enrollment, sufficient treatment and follow-up of patients to assess the primary and secondary endpoints, and conduct necessary analyses to evaluate the benefit-risk profile of imetelstat in lower risk MDS to reach top-line results in the second half of 2022; (vii) whether the Company has sufficient funding to commercialize imetelstat; (viii) whether Geron overcomes all the potential delays, added expense and other adverse impacts caused by the continuing and evolving effects of the novel coronavirus (COVID-19) pandemic; and (ix) 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 September 30, 2020. 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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    • Data and analyses highlight the differentiating clinical benefits of imetelstat treatment observed in both the Phase 2 IMerge and IMbark trials
    • Additional clinical analyses and data presented on the depletion of abnormal clones and disease mutations strongly suggest that imetelstat has disease-modifying activity
    • Biomarker data on reductions in telomerase activity and hTERT expression correlated with clinical outcomes provides evidence of on-target activity of imetelstat
    • All ten abstracts submitted were accepted for presentation
    • Presentations provide further support of ongoing and upcoming Phase 3 clinical trials of imetelstat

    Geron Corporation (NASDAQ:GERN), a late-stage clinical biopharmaceutical company, today announced that four…

    • Data and analyses highlight the differentiating clinical benefits of imetelstat treatment observed in both the Phase 2 IMerge and IMbark trials
    • Additional clinical analyses and data presented on the depletion of abnormal clones and disease mutations strongly suggest that imetelstat has disease-modifying activity
    • Biomarker data on reductions in telomerase activity and hTERT expression correlated with clinical outcomes provides evidence of on-target activity of imetelstat
    • All ten abstracts submitted were accepted for presentation
    • Presentations provide further support of ongoing and upcoming Phase 3 clinical trials of imetelstat

    Geron Corporation (NASDAQ:GERN), a late-stage clinical biopharmaceutical company, today announced that four oral presentations and six poster presentations containing clinical data and analyses related to imetelstat, the Company's first-in-class telomerase inhibitor, were presented at the 62nd American Society of Hematology (ASH) Annual Meeting. The presentations are available at www.geron.com/r-d/publications.

    "Our imetelstat presentations at this year's ASH provide strong support for our two registration-enabling Phase 3 clinical trials: IMerge, in lower risk MDS and IMpactMF, in refractory MF," said Aleksandra Rizo, M.D., Ph.D., Geron's Chief Medical Officer. "We believe the analyses and data from our Phase 2 IMerge and IMbark trials provide strong evidence of imetelstat's disease-modifying activity, as well as clinical benefits of durable transfusion independence in MDS and improvement in overall survival in MF."

    Lower Risk Myelodysplastic Syndromes (MDS) – Oral Presentation

    Title: Treatment with Imetelstat Provides Durable Transfusion Independence (TI) in Heavily Transfused Non-del(5q) Lower Risk MDS (LR-MDS) Relapsed/Refractory (R/R) to Erythropoiesis Stimulating Agents (ESAs) (Abstract #658)

    The oral presentation reported long-term efficacy, safety and biomarker data from 38 patients in the IMerge Phase 2 clinical trial, based on a February 4, 2020 cut-off date and a median follow-up of 24 months. Consistent with prior presentations, 42% of patients achieved >8-week red blood cell transfusion independence (RBC-TI) with a median duration of 20 months, which is the longest so far reported with any agent in relapsed/refractory non-del(5q) lower risk MDS. In addition, 29% of patients were transfusion free more than a year. Reduction in the SF3B1 mutation, one of the key mutations correlated with ineffective erythropoiesis in lower risk MDS, correlated with longer transfusion independence and shorter onset to achieve transfusion independence. These biomarker data together with the durability of transfusion independence provide evidence for the disease-modifying activity of imetelstat. These data were previously presented at the European Hematology Association (EHA) Annual Congress in June.

    Relapsed/Refractory Myelofibrosis (MF) – Three Oral Presentations

    Title: Potential Disease-Modifying Activity of Imetelstat Demonstrated By Reduction in Cytogenetically Abnormal Clones and Mutation Burden Leads to Clinical Benefits in Relapsed/Refractory Myelofibrosis Patients (Abstract #346)

    This oral presentation reported significant dose-dependent reduction of mutation burden by imetelstat, including complete elimination of mutations in MF driver and non-driver genes. A greater than 20% reduction in variant allele frequency by imetelstat treatment correlated with improved clinical benefits, including higher rates of spleen and symptom responses, bone marrow fibrosis improvement and longer overall survival (OS). As concluded in the presentation, imetelstat demonstrated disease-modifying activity by targeting malignant clones, improvement in bone marrow fibrosis and OS.

    Title: Telomerase Activity, Telomere Length and hTERT Expression Correlate with Clinical Outcomes in Higher-Risk Myelofibrosis (MF) Relapsed/Refractory (R/R) to Janus Kinase Inhibitor Treated with Imetelstat (Abstract #347)

    This oral presentation reported dose-dependent inhibition of telomerase, as evaluated by reductions in telomerase activity, human reverse transcriptase (hTERT) levels and telomere length in patients treated with imetelstat in the IMbark Phase 2 clinical trial. Analyses of these biomarker data correlated with clinical responses and longer OS. In addition, dose-dependent reduction in variant allele frequency of driver mutations was noted, indicating that imetelstat has disease-modifying activity by targeting the underlying MF malignant clones. As expected for a telomerase inhibitor, treatment with imetelstat at 9.4 mg/kg improved clinical outcomes in patients with shorter telomeres and higher hTERT expression at baseline. These data are consistent with telomere biology in cancer cells and provide evidence for on-target mechanism of action of imetelstat through telomerase inhibition. These results were previously reported as a poster presentation at the EHA Annual Congress in June.

    Title: Favorable Overall Survival with Imetelstat Treatment Correlates with Other Clinical Benefits in Intermediate-2 or High-Risk Myelofibrosis Relapsed/Refractory to Janus Kinase Inhibitor (Abstract #53)

    This oral presentation reported the correlation of overall survival results from the IMbark Phase 2 with clinical benefits observed with imetelstat treatment. The correlation analyses showed a trend of longer OS in patients who achieved symptom response, spleen volume reductions ranging from > 10% to > 35%, and statistically significant improvement in OS in patients with improved bone marrow fibrosis, in a dose-dependent manner. These results were previously reported as a poster presentation at the EHA Annual Congress in June.

    Relapsed/Refractory Myelofibrosis (MF) – Three Poster Presentations

    Collectively, these poster presentations described on-target and disease-modifying activity of the higher dose of imetelstat from the IMbark Phase 2, and how that relates to better clinical outcomes, including OS, fibrosis improvement and symptom response, especially in a subset of patients defined as triple negative MF, known to have poor outcome.

    Title: Correlation Analyses of Imetelstat Exposure with Pharmacodynamic Effect, Efficacy and Safety in A Phase 2 Study in Patients with Higher-risk Myelofibrosis Refractory to Janus Kinase Inhibitor Identified an Optimal Dosing Regimen for Phase 3 Study (Abstract #1283)

    Title: Imetelstat Treatment Results in Clinical Benefits, Including Improved Overall Survival, in Patients with Higher-Risk Triple Negative Myelofibrosis Relapsed/Refractory to Janus Kinase Inhibitors (JAKi) (Abstract #3084)

    Title: Treatment with Imetelstat Improves Myelofibrosis-Related Symptoms and Other Patient-Reported Outcomes in Patients with Relapsed or Refractory Higher-Risk Myelofibrosis (Abstract #3088)

    Myeloproliferative Neoplasms (MPN) – Poster Presentation

    Title: Imetelstat Inhibits Telomerase and Prevents Propagation of ADAR1-Activated Myeloproliferative Neoplasm and Leukemia Stem Cells (Abstract #1264)

    Collaborators at UC San Diego reported non-clinical data on hTERT and ADAR1 activity in pre-leukemia stem cells and leukemia stem cells (LSC). In various lab experiments and animal models, treatment with imetelstat prevented pre-leukemia stem cells from evolving into LSCs, suggesting telomerase inhibition may be an effective strategy for preventing MPN progression.

    Two Trials in Progress Poster Presentations – Ongoing IMerge Phase 3 and Upcoming IMpactMF Phase 3

    Title: IMerge: A Phase 3 Study to Evaluate Imetelstat in Transfusion-Dependent Subjects with IPSS Low or Intermediate-1 Risk Myelodysplastic Syndromes (MDS) that is Relapsed/Refractory to Erythropoiesis-Stimulating Agent (ESA) Treatment (Abstract #3113)

    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 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 IMerge Phase 3 is currently enrolling patients.

    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.

    Title: A Randomized Open-Label, Phase 3 Study to Evaluate Imetelstat Versus Best Available Therapy in Patients with Intermediate-2 or High-risk Myelofibrosis (MF) Refractory to Janus Kinase (JAK) Inhibitor (Abstract #2194)

    The IMpactMF Phase 3 clinical trial in refractory MF is a registration-enabling trial with OS as the primary endpoint. Approximately 320 patients with Intermediate-2 or High-risk MF will be randomized to receive either imetelstat or best available therapy, which will exclude JAK inhibitors. 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.

    Geron expects the trial to be open for screening and enrollment in the first quarter of 2021.

    About Phase 2 IMerge and IMbark Trials

    The IMerge Phase 2 was an open label, single arm trial to assess the safety and efficacy of a 7.5 mg/kg dose of imetelstat administered as an intravenous infusion every four weeks in transfusion dependent lower risk MDS patients who had relapsed after or were refractory to prior treatment with ESA. The IMerge Phase 2 is no longer enrolling patients, and patients remaining in the treatment phase continue to receive imetelstat treatment, per investigator discretion.

    The IMbark Phase 2 was designed to evaluate two dosing regimens of imetelstat (either 4.7 mg/kg or 9.4 mg/kg administered by intravenous infusion every three weeks) in patients with Intermediate-2 or High-risk myelofibrosis (MF) who have relapsed after or are refractory to prior treatment with a janus kinase inhibitor (JAKi). The co-primary efficacy endpoints for IMbark were spleen response rate, defined as the proportion of patients who achieve a reduction of at least 35% in spleen volume as assessed by imaging, and symptom response rate, defined as the proportion of patients who achieve a reduction of at least 50% in Total Symptom Score (TSS), at 24 weeks. Key secondary endpoints were overall survival (OS) and safety. The trial is complete and closed.

    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 strongly suggest that imetelstat has disease-modifying activity through the apoptosis of malignant stem and progenitor cells, which allows potential recovery of normal hematopoiesis. Current clinical studies of imetelstat include IMerge, an ongoing Phase 2/3 trial in lower risk myelodysplastic syndromes (MDS), and IMpactMF, an upcoming Phase 3 clinical trial in refractory myelofibrosis (MF). 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 clinical stage 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.

    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 survival benefit for MF patients who have relapsed after, or are refractory to, prior treatment with a JAKi (relapsed/refractory MF); (ii) that the analyses and data from IMbark and IMerge provide strong evidence that imetelstat has disease-modifying activity, may enable patients to have clinical benefits of durable transfusion independence in MDS and improvement in overall survival in MF; (iii) that analyses and data presented on the depletion of abnormal clones and disease mutations strongly suggest that imetelstat has 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 whether: (i) imetelstat in clinical trials is able to demonstrate an overall survival benefit in patients who have relapsed/refractory MF; (ii) imetelstat demonstrates disease-modifying activity and durable transfusion independence in MDS in clinical trials; (iii) regulatory authorities permit the further development of imetelstat; (iv) imetelstat is safe and efficacious; and (v) any future efficacy or safety results cause the benefit-risk profile of imetelstat to become unacceptable. 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 September 30, 2020. 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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  22. 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 18, 2020 at an exercise price of $1.90 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 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 18, 2020 at an exercise price of $1.90 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 a material inducement to employment in accordance with Nasdaq Listing Rule 5635(c)(4) and is subject to the terms and conditions of a 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 myeloid malignancies. For more information about Geron, visit www.geron.com.

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  23. Geron Corporation (NASDAQ:GERN), a late-stage clinical biopharmaceutical company, today announced that John A. Scarlett, M.D., Chairman and Chief Executive Officer, will present a company overview at the Stifel Virtual Healthcare Conference on Tuesday, November 17, 2020 at 2:40 p.m. ET.

    A live audio webcast of the presentation will be available on Geron's website, www.geron.com/investors/events. If you are unable to listen to the live presentation, an archived webcast will be available on the Company's website for 30 days.

    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…

    Geron Corporation (NASDAQ:GERN), a late-stage clinical biopharmaceutical company, today announced that John A. Scarlett, M.D., Chairman and Chief Executive Officer, will present a company overview at the Stifel Virtual Healthcare Conference on Tuesday, November 17, 2020 at 2:40 p.m. ET.

    A live audio webcast of the presentation will be available on Geron's website, www.geron.com/investors/events. If you are unable to listen to the live presentation, an archived webcast will be available on the Company's website for 30 days.

    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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  24. FOSTER CITY, Calif., Nov. 05, 2020 (GLOBE NEWSWIRE) -- Geron Corporation (NASDAQ:GERN), a late-stage clinical biopharmaceutical company, today reported financial results for the third quarter ended September 30, 2020. The Company will host a conference call today at 4:30 p.m. ET to discuss third quarter financial results and current events. As of September 30, 2020, Geron had approximately $274 million in cash and investments. Based on current planning assumptions, the Company estimates its current financial resources to be sufficient for its operations until the end of 2022.

    "In the third quarter, we executed on our clinical, regulatory and publication plans for the imetelstat program," said John A. Scarlett, M.D., Chairman and Chief Executive…

    FOSTER CITY, Calif., Nov. 05, 2020 (GLOBE NEWSWIRE) -- Geron Corporation (NASDAQ:GERN), a late-stage clinical biopharmaceutical company, today reported financial results for the third quarter ended September 30, 2020. The Company will host a conference call today at 4:30 p.m. ET to discuss third quarter financial results and current events. As of September 30, 2020, Geron had approximately $274 million in cash and investments. Based on current planning assumptions, the Company estimates its current financial resources to be sufficient for its operations until the end of 2022.

    "In the third quarter, we executed on our clinical, regulatory and publication plans for the imetelstat program," said John A. Scarlett, M.D., Chairman and Chief Executive Officer. "We continued to advance both the enrollment of the ongoing IMerge Phase 3 clinical trial and start-up activities for the upcoming Phase 3 clinical trial in refractory myelofibrosis, which we have named IMpactMF. We also secured European orphan drug designation in lower risk MDS; received acceptance for presentation of all ten abstracts submitted to the ASH Annual Meeting; and had the IMerge Phase 2 data published in the well-respected Journal of Clinical Oncology. In addition, we strengthened our balance sheet with a loan facility that provides additional financial flexibility to support our plans for imetelstat development going forward."

    Dr. Scarlett added, "We continue to work toward completing enrollment in IMerge in the first quarter of 2021. However, the recent resurgence of the COVID-19 pandemic is causing an uncertain and unpredictable impact on clinical trial activities. Due to these challenges, we now believe the trial will most likely be fully enrolled in the second quarter of 2021. As long as enrollment is complete by the end of the first half of 2021, we continue to expect top-line results from IMerge to be available in the second half of 2022, as previously guided. Based on current feedback from clinical sites planned to participate in IMpactMF, we continue to expect that trial to be open for screening and enrollment in the first quarter of 2021."

    Current Events – Clinical Development

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

    Enrollment for the IMerge Phase 3 clinical trial continued to progress in the third quarter. In August 2020, all 92 of the originally planned clinical sites were open for enrollment.

    To address enrollment delays related to the COVID-19 pandemic experienced earlier this year, Geron implemented certain enrollment boosting activities, including engaging clinical science liaisons to interface directly with clinical sites and expanding the number of clinical sites to diversify the participating countries. The Company currently expects to add approximately 30 new clinical sites in several countries, including new sites in four additional countries that had not previously participated in IMerge. The Company expects almost all of the new sites to be open for screening and enrollment by the end of 2020.

    Under current planning assumptions, the Company expects enrollment in the IMerge Phase 3 trial to be complete in the second quarter of 2021 and continues to expect top-line results to be available in the second half of 2022. This anticipated timing is subject to potential delays or interruptions associated with the evolving effects of the ongoing COVID-19 pandemic, which causes unpredictability when projecting future enrollment trends.

    Upcoming IMpactMF Phase 3 Clinical Trial in Myelofibrosis (MF)

    The Phase 3 clinical trial in refractory MF with overall survival (OS) as its primary endpoint, named IMpactMF, is expected to be open for screening and enrollment in the first quarter of 2021. Geron expects to engage over 150 sites across North America, South America, Europe and Asia. The clinical trial protocol has been finalized and is available on clinicaltrials.gov. Trial start-up activities are ongoing and include site selection, engagement of vendors, and building of the clinical trial database.

    The final analysis for OS is event-driven and is planned to be conducted after more than 50% of the patients enrolled in the trial have died. An interim analysis of OS is planned to be conducted after approximately 70% of the total projected number of events for the final analysis have occurred. If the pre-specified, statistically significant difference in OS between the two treatment arms is met at the interim analysis, it is possible that data from the interim analysis could support a registration filing. Both the planned interim and final analyses are event-driven and could occur on different timelines than currently expected.

    Under current planning assumptions, Geron plans to complete patient enrollment in the second half of 2022, to conduct an interim analysis in the first half of 2023 and to conduct a final analysis in the first half of 2024.

    Financial Resources to Reach Clinical Milestones

    The Company's current cash position reflects net proceeds of approximately $140 million from a public offering in May 2020 and approximately $24 million in initial net proceeds from a $75 million loan facility that closed at the end of the third quarter. The loan facility is available through year-end 2022 in three tranches subject to the achievement of certain clinical, financial and regulatory milestones. The loan facility provides access to non-dilutive financial resources to support the imetelstat development program, as well as working capital and general corporate purposes.

    Third Quarter and Year-to-Date 2020 Results

    For the third quarter of 2020, the Company reported a net loss of $19.7 million, or $0.06 per share, compared to $15.2 million, or $0.08 per share, for the comparable 2019 period. Net loss for the first nine months of 2020 was $51.8 million, or $0.20 per share, compared to $39.5 million, or $0.21 per share, for the comparable 2019 period.

    Revenues for the three and nine months ended September 30, 2020 were $108,000 and $203,000, respectively, compared to $131,000 and $289,000 for the comparable 2019 periods. Revenues in 2020 and 2019 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 future product sales.

    Total operating expenses for the three and nine months ended September 30, 2020 were $20.1 million and $53.9 million, respectively, compared to $16.1 million and $42.8 million for the comparable 2019 periods.

    Research and development expenses for the three and nine months ended September 30, 2020 were $13.6 million and $35.3 million, respectively, compared to $11.1 million and $27.1 million for the comparable 2019 periods. The increase in research and development expenses for the three and nine months ended September 30, 2020, compared to the same periods in 2019, primarily reflects increased costs to support the ongoing IMerge Phase 3 and start-up activities for the upcoming IMpactMF Phase 3 clinical trial. The increase also includes higher costs in connection with validating the imetelstat manufacturing process at contract manufacturers and additional personnel-related costs for expansion of the development team in 2019.

    General and administrative expenses for the three and nine months ended September 30, 2020 were $6.5 million and $18.6 million, respectively, compared to $5.0 million and $15.6 million for the comparable 2019 periods. The increase in general and administrative expenses for the three and nine months ended September 30, 2020, compared to same periods in 2019, primarily reflects higher personnel-related expenses for additional general and administrative headcount to support growing operational activities and increased legal costs.

    Interest and other income for the three and nine months ended September 30, 2020 was $504,000 and $1.7 million, respectively, compared to $1.0 million and $3.3 million for the comparable 2019 periods. The decrease in interest and other income for the three and nine months ended September 30, 2020, compared to same periods in 2019, primarily reflects lower yields on the Company's marketable securities portfolio due to declining interest rates.

    2020 Financial Guidance Reaffirmed

    The Company continues to expect its 2020 operating expense burn to range from $70 to $75 million. This guidance includes new costs for start-up activities associated with the IMpactMF Phase 3 clinical trial and additional costs for the expansion of clinical sites for the IMerge Phase 3 clinical trial.

    Conference Call

    Geron will host a conference call at 4:30 p.m. ET on Thursday, November 5, 2020 to discuss third quarter financial results and recent events.

    A live, listen-only webcast will be available on the Company's website at www.geron.com/investors/events. If you are unable to listen to the live call, an archived 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/7879966. 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. 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 registration-enabling studies, IMerge, an ongoing Phase 2/3 clinical trial in lower risk myelodysplastic syndromes (MDS), and IMpactMF, an upcoming 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 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. 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 imetelstat may have disease-modifying activity; (ii) that Geron's current financial resources are sufficient for its operations until the end of 2022; (iii) that IMpactMF will be open for screening and enrollment in the first quarter of 2021; (iv) that the loan facility is available through the end of 2022 subject to the achievement of certain clinical, financial and regulatory milestones; (v) that IMerge will likely be fully enrolled by the end of the second quarter of 2021; (vi) that top-line results for IMerge will be available in the second half of 2022; (vii) that almost all of the new IMerge sites will be open for screening and enrollment by the end of 2020; (viii) the possibility that data from the IMpactMF interim analysis could support a registrational filing; (ix) that under current planning assumptions, for IMpactMF Geron expects to complete patient enrollment in the second half of 2022, conduct an interim analysis in the first half of 2023 and conduct a final analysis in the first half of 2024; (x) that Geron's 2020 expense burn will range from $70 to $75 million; and (xi) 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 clinical, safety, efficacy, technical, scientific, intellectual property, manufacturing and regulatory challenges in order to meet the expected timelines and planned milestones in (iii), (v), (vi), (vii) and (ix) 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 clinical trials; (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), (v), (vi), (vii) and (ix) above; (h) whether Geron is able to achieve the required milestones to be eligible for the additional tranches of the loan facility; (i) whether there are failures or delays in manufacturing 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 2020 due to the current or evolving effects of the COVID-19 pandemic or otherwise; and (l) whether Geron can accurately project the timing of, or attain complete enrollment in IMerge or IMpactMF, whether due to the current or evolving effects of the COVID-19 pandemic or otherwise. 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 September 30, 2020 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

     Nine Months Ended

     September 30,

     September 30,

    (In thousands, except share and per share data)2020

     2019

     2020

     2019

                    
    Revenues:               
    License fees and royalties$108  $131  $203  $289 
                    
    Operating expenses:               
    Research and development 13,613   11,109   35,260   27,149 
    General and administrative 6,510   4,994   18,590   15,637 
    Total operating expenses 20,123   16,103   53,850   42,786 
    Loss from operations (20,015)  (15,972)  (53,647)  (42,497)
                    
    Interest and other income 504   1,021   1,733   3,296 
    Change in fair value of equity investment (118)  (195)  109   (195)
    Interest and other expense (22)  (34)  (25)  (82)
    Net loss$(19,651) $(15,180) $(51,830) $(39,478)
                    
    Basic and diluted net loss per share:               
    Net loss per share$(0.06) $(0.08) $(0.20) $(0.21)
    Shares used in computing net loss per share 318,799,174   189,123,647   255,560,779   187,367,621 

    CONDENSED BALANCE SHEETS

     September 30, December 31,
    (In thousands)2020 2019
     (Unaudited) (Note 1)
    Current assets:    
    Cash, cash equivalents and restricted cash$45,319 $13,914
    Current marketable securities 182,667  125,681
    Other current assets 3,875  2,013
    Total current assets 231,861  141,608
         
    Noncurrent marketable securities 45,768  19,651
    Property and equipment, net 689  408
    Deposits and other assets 7,475  3,850
     $285,793 $165,517
         
    Current liabilities$24,154 $28,162
    Noncurrent liabilities 28,807  2,200
    Stockholders' equity 232,832  135,155
     $285,793 $165,517
         

    Note 1:  Derived from audited financial statements included in the Company's annual report on Form 10-K for the year ended December 31, 2019.

    CONTACT:

    Suzanne Messere

    Investor and Media Relations

    investor@geron.com

    media@geron.com

    Primary Logo

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  25. Geron Corporation (NASDAQ:GERN), a late-stage clinical biopharmaceutical company, today announced that ten abstracts containing clinical data and analyses related to imetelstat, the Company's first-in-class telomerase inhibitor, have been accepted for presentation at the 62nd American Society of Hematology (ASH) Annual Meeting to be held online from December 5-8, 2020. The abstracts are available on the ASH website at www.hematology.org.

    "We are pleased that all ten of the abstracts we submitted were accepted for presentation at this year's ASH Meeting," said Aleksandra Rizo, M.D., Ph.D., Geron's Chief Medical Officer. "The analyses and data from our Phase 2 IMbark and IMerge trials reported in these abstracts continue to support our ongoing…

    Geron Corporation (NASDAQ:GERN), a late-stage clinical biopharmaceutical company, today announced that ten abstracts containing clinical data and analyses related to imetelstat, the Company's first-in-class telomerase inhibitor, have been accepted for presentation at the 62nd American Society of Hematology (ASH) Annual Meeting to be held online from December 5-8, 2020. The abstracts are available on the ASH website at www.hematology.org.

    "We are pleased that all ten of the abstracts we submitted were accepted for presentation at this year's ASH Meeting," said Aleksandra Rizo, M.D., Ph.D., Geron's Chief Medical Officer. "The analyses and data from our Phase 2 IMbark and IMerge trials reported in these abstracts continue to support our ongoing Phase 3 trial in lower risk MDS and our upcoming Phase 3 trial in refractory MF and highlight the clinical benefits and the potential disease-modifying activity achievable with imetelstat treatment."

    Lower Risk Myelodysplastic Syndromes (MDS) – Oral Presentation

    Abstract Title: Treatment with Imetelstat Provides Durable Transfusion Independence (TI) in Heavily Transfused Non-del(5q) Lower Risk MDS (LR-MDS) Relapsed/Refractory (R/R) to Erythropoiesis Stimulating Agents (ESAs)

    Long-term efficacy, safety and biomarker data from 38 patients in the IMerge Phase 2 clinical trial, based on a February 4, 2020 cut-off date and a median follow-up of 24 months, are reported. Consistent with prior presentations, 42% of patients achieved >8-week red blood cell transfusion independence (RBC-TI) with a median duration of 20 months, which is the longest so far reported with any agent in relapsed/refractory non-del(5q) lower risk MDS. In addition, 29% of patients were transfusion free more than a year. These data were previously presented at the European Hematology Association (EHA) Annual Congress in June.

    Oral Presentation Details

    Abstract: #658

    Date: Monday, December 7, 2020

    Time: 12:45 p.m. PT

    Relapsed/Refractory Myelofibrosis (MF) – Three Oral Presentations

    Abstract Title: Potential Disease-Modifying Activity of Imetelstat Demonstrated By Reduction in Cytogenetically Abnormal Clones and Mutation Burden Leads to Clinical Benefits in Relapsed/Refractory Myelofibrosis Patients

    Results from new analyses on samples from patients in the IMbark Phase 2 clinical trial highlight significant dose-dependent reductions of mutation burden by imetelstat. These results were correlated with improved overall clinical benefits, including higher rates of spleen and symptom responses, bone marrow fibrosis improvement and prolonged overall survival (OS). As concluded in the abstract, the clinical data that suggest improvement in median OS in these patients, together with the data in the abstract, further demonstrate that imetelstat has disease-modifying activity by targeting malignant cells, as evidenced by depletion of cytogenetically abnormal clones and reduction in mutation burden.

    Oral Presentation Details

    Abstract: #346

    Date: Sunday, December 6, 2020

    Time: 10:30 a.m. PT

    Abstract Title: Telomerase Activity, Telomere Length and hTERT Expression Correlate with Clinical Outcomes in Higher-Risk Myelofibrosis (MF) Relapsed/Refractory (R/R) to Janus Kinase Inhibitor Treated with Imetelstat

    Dose-dependent inhibition of the telomerase target, as evaluated by reductions in telomerase activity, human reverse transcriptase (hTERT) levels and telomere length, reported in patients treated with imetelstat in the IMbark Phase 2 clinical trial. Analyses of these biomarker data correlated with clinical responses and longer OS. In addition, dose-dependent reduction in variant allele frequency of driver mutations was noted, indicating that imetelstat targets the underlying clone. These data are consistent with telomere biology in cancer cells and provide evidence for on-target mechanism of action of imetelstat through telomerase inhibition. These results were previously reported as a poster presentation at the EHA Annual Congress in June.

    Oral Presentation Details

    Abstract: #347

    Date: Sunday, December 6, 2020

    Time: 10:45 a.m. PT

    Abstract Title: Favorable Overall Survival with Imetelstat Treatment Correlates with Other Clinical Benefits in Intermediate-2 or High-Risk Myelofibrosis Relapsed/Refractory to Janus Kinase Inhibitor

    Overall survival results from IMbark Phase 2 were correlated with clinical benefits observed with imetelstat treatment. The correlation analyses showed a trend of longer OS in patients who achieved symptom response, spleen volume reductions ranging from > 10% to > 35%, and improvement in bone marrow fibrosis, in a dose-dependent manner. These results were previously reported as a poster presentation at the EHA Annual Congress in June.

    Oral Presentation Details

    Abstract: #53

    Date: Saturday, December 5, 2020

    Time: 8:00 a.m. PT

    Relapsed/Refractory Myelofibrosis (MF) – Three Poster Presentations

    Collectively, these poster presentations describe on-target and potential disease-modifying activity of the higher dose of imetelstat from the IMbark Phase 2, and how that relates to better clinical outcomes, including OS, fibrosis improvement; and symptom response, especially in a subset of patients defined as triple negative MF, known to have poor outcome.

    Abstract Title: Correlation Analyses of Imetelstat Exposure with Pharmacodynamic Effect, Efficacy and Safety in A Phase 2 Study in Patients with Higher-risk Myelofibrosis Refractory to Janus Kinase Inhibitor Identified an Optimal Dosing Regimen for Phase 3 Study

    Poster Presentation Details

    Abstract: #1283

    Date: Saturday, December 5, 2020

    Time: 7:00 a.m. – 3:30 p.m. PT

    Abstract Title: Imetelstat Treatment Results in Clinical Benefits, Including Improved Overall Survival, in Patients with Higher-Risk Triple Negative Myelofibrosis Relapsed/Refractory to Janus Kinase Inhibitors (JAKi)

    Poster Presentation Details

    Abstract: #3084

    Date: Monday, December 7, 2020

    Time: 7:00 a.m. – 3:30 p.m. PT

    Abstract Title: Treatment with Imetelstat Improves Myelofibrosis-Related Symptoms and Other Patient-Reported Outcomes in Patients with Relapsed or Refractory Higher-Risk Myelofibrosis

    Poster Presentation Details

    Abstract: #3088

    Date: Monday, December 7, 2020

    Time: 7:00 a.m. – 3:30 p.m. PT

    Myeloproliferative Neoplasms (MPN) –Poster Presentation

    Collaborators at UC San Diego report non-clinical data on hTERT and ADAR1 activity in pre-leukemia stem cells and leukemia stem cells (LSC). In various lab experiments and animal models, treatment with imetelstat can prevent pre-leukemia stem cells from evolving into LSCs, suggesting telomerase inhibition may be an effective strategy for preventing MPN progression.

    Abstract Title: Imetelstat Inhibits Telomerase and Prevents Propagation of ADAR1-Activated Myeloproliferative Neoplasm and Leukemia Stem Cells

    Poster Presentation Details

    Abstract: #1264

    Date: Saturday, December 5, 2020

    Time: 7:00 a.m. – 3:30 p.m. PT

    Two Trials in Progress Poster Presentations – Planned Phase 3 in Refractory MF and Ongoing IMerge Phase 3

    Abstracts for this category describe innovative clinical trials that have not reached their primary endpoint to provide opportunities for early engagement and collaboration amongst investigators, translational research, clinical and industry investigators, statisticians and regulators.

    Abstract Title: A Randomized Open-Label, Phase 3 Study to Evaluate Imetelstat Versus Best Available Therapy in Patients with Intermediate-2 or High-risk Myelofibrosis (MF) Refractory to Janus Kinase (JAK) Inhibitor

    Poster Presentation Details

    Abstract: #2194

    Date: Sunday, December 6, 2020

    Time: 7:00 a.m. – 3:00 p.m. PT

    Abstract Title: IMerge: A Phase 3 Study to Evaluate Imetelstat in Transfusion-Dependent Subjects with IPSS Low or Intermediate-1 Risk Myelodysplastic Syndromes (MDS) that is Relapsed/Refractory to Erythropoiesis-Stimulating Agent (ESA) Treatment

    Poster Presentation Details

    Abstract: #3113

    Date: Monday, December 7, 2020

    Time: 7:00 a.m. – 3:30 p.m. PT

    In accordance with ASH policies, abstracts submitted to the ASH Annual Meeting are embargoed from the time of submission. To be eligible for presentation at the ASH Annual Meeting, any additional data or information to be presented at the Annual Congress may not be made public before the presentation. The slide presentation and posters will be available at www.geron.com/r-d/publications following the ASH Annual Meeting presentations.

    Ongoing IMerge Phase 2/3 Clinical Trial

    The IMerge Phase 2/3 trial is a two-part clinical trial of imetelstat in transfusion dependent patients with Low or Intermediate-1 risk, also referred to as lower risk myelodysplastic syndromes (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.

    The IMerge Phase 2 was an open label, single arm trial to assess the safety and efficacy of imetelstat of a 7.5 mg/kg dose of imetelstat administered as an intravenous infusion every four weeks. The IMerge Phase 2 is no longer enrolling patients, and patients remaining in the treatment phase continue to receive imetelstat treatment, per investigator discretion.

    The IMerge Phase 3 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 meet the defined target patient population identified in the Phase 2 portion of the trial. The IMerge Phase 3 is currently enrolling patients.

    IMbark Phase 2 Clinical Trial

    IMbark was designed as a Phase 2 clinical trial to evaluate two dosing regimens of imetelstat (either 4.7 mg/kg or 9.4 mg/kg administered by intravenous infusion every three weeks) in patients with Intermediate-2 or High-risk myelofibrosis (MF) who have relapsed after or are refractory to prior treatment with a janus kinase inhibitor (JAKi). The co-primary efficacy endpoints for IMbark were spleen response rate, defined as the proportion of patients who achieve a reduction of at least 35% in spleen volume as assessed by imaging, and symptom response rate, defined as the proportion of patients who achieve a reduction of at least 50% in Total Symptom Score (TSS), at 24 weeks. Key secondary endpoints were overall survival (OS) and safety.

    Phase 3 Clinical Trial in Refractory Myelofibrosis

    The Phase 3 clinical trial in refractory MF, with OS as the primary endpoint, is an open label 2:1 randomized, controlled clinical trial to evaluate imetelstat in approximately 320 patients with Intermediate-2 or High-risk disease who are refractory to prior treatment with a JAK inhibitor. Patients refractory to a JAK inhibitor are defined as having an inadequate spleen response or symptom response after treatment with a JAK inhibitor for at least six months, including an optimal dose of a JAK inhibitor for at least two months. The control arm of best available therapy excludes JAK inhibitors. 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.

    Geron expects the trial to be open for screening and enrollment in the first quarter of 2021.

    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. Current clinical studies of imetelstat include IMerge, an ongoing Phase 2/3 trial in lower risk myelodysplastic syndromes (MDS), and a planned Phase 3 clinical trial in refractory myelofibrosis (MF). 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 clinical stage 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.

    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 survival benefit for MF patients who have relapsed after, or are refractory to, prior treatment with a JAKi (relapsed/refractory MF); (ii) that imetelstat may have disease-modifying activity; and (iii) 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 whether: (i) imetelstat in clinical trials is able to demonstrate an overall survival benefit in patients who have relapsed after, or are refractory to, prior treatment with a JAKi (relapsed/refractory MF); (ii) imetelstat demonstrates disease-modifying activity in clinical trials; (iii) regulatory authorities permit the further development of imetelstat; (iv) imetelstat is safe and efficacious; and (v) any future efficacy or safety results cause the benefit-risk profile of imetelstat to become unacceptable. 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 June 30, 2020. 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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  26. Geron Corporation (NASDAQ:GERN) today announced that it will release its third quarter 2020 financial results after the market closes on Thursday, November 5, 2020 via press release, which will be available on the Company's website at www.geron.com/investors. Geron will host a conference call to discuss the financial results as well as recent events at 4:30 p.m. ET the same day.

    A live, listen-only webcast will be available on the Company's website at www.geron.com/investors/events. If you are unable to listen to the live call, an archived 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/7879966

    Geron Corporation (NASDAQ:GERN) today announced that it will release its third quarter 2020 financial results after the market closes on Thursday, November 5, 2020 via press release, which will be available on the Company's website at www.geron.com/investors. Geron will host a conference call to discuss the financial results as well as recent events at 4:30 p.m. ET the same day.

    A live, listen-only webcast will be available on the Company's website at www.geron.com/investors/events. If you are unable to listen to the live call, an archived 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/7879966. 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 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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  27. Results support ongoing IMerge Phase 3 clinical trial

    Geron Corporation (NASDAQ:GERN), a late-stage clinical biopharmaceutical company, today announced that data from the IMerge Phase 2 trial were published in the Journal of Clinical Oncology. The article entitled, "Imetelstat Achieves Meaningful and Durable Transfusion Independence in High-Transfusion Burden Patients with Lower Risk Myelodysplastic Syndromes Patients in a Phase 2 Study," is available online. The publication includes data from all 57 patients enrolled in the trial as well as data for the 38-patient target patient population previously reported at the European Hematology Association Annual Congress in June 2020.

    "With a median duration of 21 months, the durability of transfusion…

    Results support ongoing IMerge Phase 3 clinical trial

    Geron Corporation (NASDAQ:GERN), a late-stage clinical biopharmaceutical company, today announced that data from the IMerge Phase 2 trial were published in the Journal of Clinical Oncology. The article entitled, "Imetelstat Achieves Meaningful and Durable Transfusion Independence in High-Transfusion Burden Patients with Lower Risk Myelodysplastic Syndromes Patients in a Phase 2 Study," is available online. The publication includes data from all 57 patients enrolled in the trial as well as data for the 38-patient target patient population previously reported at the European Hematology Association Annual Congress in June 2020.

    "With a median duration of 21 months, the durability of transfusion independence observed with imetelstat in the IMerge Phase 2 trial is a clinically meaningful outcome for patients," said David Steensma, M.D., Edward P. Evans Chair in Myelodysplastic Syndromes Research at the Dana-Farber Cancer Institute and Associate Professor of Medicine at Harvard Medical School, and lead author of the article. "In addition, the reduction in malignant clone size during imetelstat treatment suggests potential disease-modifying activity, which also could be meaningful from a clinical perspective. The adverse event pattern observed in this trial was similar to previous studies of this drug."

    The publication reports efficacy, safety and biomarker results from the IMerge Phase 2 clinical trial. As stated in the paper, imetelstat treatment produced meaningful and durable transfusion independence (TI). TI was consistently observed across different patient subgroups, including ring sideroblast positive (RS+) and RS-, as well as high and very high transfusion burdened patients. The data also suggest potential disease-modifying activity with imetelstat by reducing the malignant clones driving the disease. In the IMerge Phase 2, no new safety signals were identified, and the most frequent treatment emergent adverse events were cytopenias, which were reversible and with limited clinical consequence.

    "We are pleased that the IMerge Phase 2 data have been published in one of the most prestigious oncology journals, the Journal of Clinical Oncology, and we believe that the publication of these data in JCO represents an increased level of interest from the oncology community," said Aleksandra Rizo, M.D., Ph.D., Geron's Chief Medical Officer. "The depth and breadth of transfusion independence achievable with imetelstat treatment, as seen in the IMerge Phase 2, can address the significant anemia burden for lower risk MDS patients. These data support our ongoing registration-enabling IMerge Phase 3 clinical trial in lower risk MDS being conducted at multiple sites around the world, and we are planning for top-line results in the second half of 2022."

    Ongoing IMerge Phase 2/3 Clinical Trial

    The IMerge Phase 2/3 trial is a two-part clinical trial of imetelstat in transfusion dependent patients with Low or Intermediate-1 risk, also referred to as lower risk myelodysplastic syndromes (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.

    The IMerge Phase 2 was an open label, single arm trial to assess the safety and efficacy of imetelstat of a 7.5 mg/kg dose of imetelstat administered as an intravenous infusion every four weeks. The Phase 2 enrolled 57 patients, of which a target patient population of 38 patients were naïve to treatment with a hypomethylating agent (HMA) or lenalidomide and did not have a deletion 5q chromosomal abnormality (non-del(5q)). The IMerge Phase 2 is no longer enrolling patients and patients remaining in the treatment phase continue to receive imetelstat treatment, per investigator discretion.

    The IMerge Phase 3 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 meet the defined target patient population identified in the Phase 2 portion of the trial. The IMerge Phase 3 is currently enrolling patients.

    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.

    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) potential disease-modifying activity of imetelstat; (ii) that Geron is planning for IMerge Phase 3 top-line results in the second half of 2022; (iii) that for the planned Phase 3 clinical trial in refractory MF, Geron expects to begin patient screening and enrollment in the first quarter of 2021; 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 Company overcomes all of the potential delays and other adverse impacts caused by the evolving effects of the COVID-19 pandemic, and overcomes the clinical, safety, efficacy, technical, scientific, intellectual property, manufacturing and regulatory challenges in order to complete IMerge and open and complete the planned Phase 3 in refractory MF; (b) whether regulatory authorities permit the further development of imetelstat on a timely basis, or at all, without any clinical holds; (c) whether imetelstat is demonstrated to be safe and efficacious in clinical trials; and (d) whether imetelstat demonstrates disease-modifying activity in IMerge and the planned Phase 3 in refractory MF. 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 June 30, 2020. 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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  28. Geron Corporation (NASDAQ:GERN), a late-stage clinical biopharmaceutical company, today announced that it has entered into a loan facility for up to $75 million with Hercules Capital, Inc. (NYSE:HTGC) and Silicon Valley Bank (SVB). The loan facility provides the Company with access to non-dilutive financial resources to support the imetelstat development program, as well as working capital and general corporate purposes.

    "This debt financing strengthens our balance sheet and provides additional financial flexibility as our imetelstat program advances with two Phase 3 registration-enabling clinical trials – the ongoing IMerge trial in lower risk myelodysplastic syndromes and the planned trial in refractory myelofibrosis," said Olivia K. Bloom…

    Geron Corporation (NASDAQ:GERN), a late-stage clinical biopharmaceutical company, today announced that it has entered into a loan facility for up to $75 million with Hercules Capital, Inc. (NYSE:HTGC) and Silicon Valley Bank (SVB). The loan facility provides the Company with access to non-dilutive financial resources to support the imetelstat development program, as well as working capital and general corporate purposes.

    "This debt financing strengthens our balance sheet and provides additional financial flexibility as our imetelstat program advances with two Phase 3 registration-enabling clinical trials – the ongoing IMerge trial in lower risk myelodysplastic syndromes and the planned trial in refractory myelofibrosis," said Olivia K. Bloom, Chief Financial Officer. "We look forward to working with Hercules and SVB in the future as we include non-dilutive capital in our financing strategy."

    The loan facility is available to Geron in three tranches. The Company received $25 million as part of the first tranche at closing, with the remaining $10 million available through June 15, 2021. The second tranche of an additional $15 million is available to Geron in 2021, subject to achievement of certain clinical milestones. The remaining $25 million in the third tranche is available to the Company through year-end 2022, and subject to approval from the lenders.

    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 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 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. 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 imetelstat may have disease-modifying activity; (ii) that Geron will achieve in 2021 the requisite milestones to enable it to borrow an additional $15 million; (iii) that the planned Phase 3 clinical trial in refractory MF will be open for screening and enrollment in the first quarter of 2021; (iv) that the $15 million second tranche is subject to achievement of certain clinical milestones; and (v) 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 clinical, safety, efficacy, technical, scientific, intellectual property, manufacturing and regulatory challenges in order to meet the expected timeline for opening the Phase 3 clinical trial in MF in the first quarter of 2021, and the planned milestones; (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 clinical trials; (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) Geron's 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; (h) whether the Company is able to achieve the required clinical milestones to be eligible for the $15 million second tranche; and (i) whether there are failures or delays in manufacturing 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. 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 June 30, 2020 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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  29. 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 September 16, 2020 at an exercise price of $1.81 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…

    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 September 16, 2020 at an exercise price of $1.81 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 a material inducement to employment in accordance with Nasdaq Listing Rule 5635(c)(4) and is subject to the terms and conditions of a 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 myeloid malignancies. For more information about Geron, visit www.geron.com.

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  30. Geron Corporation (NASDAQ:GERN), a late-stage clinical biopharmaceutical company, today announced that John A. Scarlett, M.D., Chairman and Chief Executive Officer, will present a company overview at the H.C. Wainwright 22nd Annual Global Investment Conference, to be hosted in a virtual format, on Monday, September 14, 2020 at 2:30 p.m. ET.

    A live audio webcast of the presentation will be available on Geron's website, www.geron.com/investors/events. If you are unable to listen to the live presentation, an archived webcast will be available on the Company's website for 30 days.

    About Geron

    Geron is a late-stage clinical biopharmaceutical company focused on the development and potential commercialization of a first-in-class telomerase inhibitor…

    Geron Corporation (NASDAQ:GERN), a late-stage clinical biopharmaceutical company, today announced that John A. Scarlett, M.D., Chairman and Chief Executive Officer, will present a company overview at the H.C. Wainwright 22nd Annual Global Investment Conference, to be hosted in a virtual format, on Monday, September 14, 2020 at 2:30 p.m. ET.

    A live audio webcast of the presentation will be available on Geron's website, www.geron.com/investors/events. If you are unable to listen to the live presentation, an archived webcast will be available on the Company's website for 30 days.

    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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  31. Geron Corporation (NASDAQ:GERN) today reported that it has granted non-statutory stock options to purchase an aggregate of 270,000 shares of Geron common stock as inducements to four newly-hired employees in connection with commencement of employment with the Company.

    The stock options were granted on August 19, 2020 at an exercise price of $1.79 per share, which is equal to the closing price of Geron common stock on the date of grant. Each stock option granted 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…

    Geron Corporation (NASDAQ:GERN) today reported that it has granted non-statutory stock options to purchase an aggregate of 270,000 shares of Geron common stock as inducements to four newly-hired employees in connection with commencement of employment with the Company.

    The stock options were granted on August 19, 2020 at an exercise price of $1.79 per share, which is equal to the closing price of Geron common stock on the date of grant. Each stock option granted 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 options were granted as a material inducement to employment in accordance with Nasdaq Listing Rule 5635(c)(4) and are subject to the terms and conditions of a 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 myeloid malignancies. For more information about Geron, visit www.geron.com.

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  32. Geron Corporation (NASDAQ:GERN), a late-stage clinical biopharmaceutical company, today reported financial results for the second quarter ended June 30, 2020. The Company will host a conference call today at 4:30 p.m. ET to discuss second quarter financial results and current events.

    "In the second quarter, we achieved a number of key milestones that have changed the trajectory of the Company," said John A. Scarlett, M.D., Chairman and Chief Executive Officer. "After a successful meeting with the FDA, we announced plans to move forward with a Phase 3 clinical trial in refractory MF with overall survival as the primary endpoint. This decision was based on overall survival data from the IMbark Phase 2 trial that suggest imetelstat treatment…

    Geron Corporation (NASDAQ:GERN), a late-stage clinical biopharmaceutical company, today reported financial results for the second quarter ended June 30, 2020. The Company will host a conference call today at 4:30 p.m. ET to discuss second quarter financial results and current events.

    "In the second quarter, we achieved a number of key milestones that have changed the trajectory of the Company," said John A. Scarlett, M.D., Chairman and Chief Executive Officer. "After a successful meeting with the FDA, we announced plans to move forward with a Phase 3 clinical trial in refractory MF with overall survival as the primary endpoint. This decision was based on overall survival data from the IMbark Phase 2 trial that suggest imetelstat treatment could potentially double the remaining life expectancy for patients who have become refractory to JAK inhibitors."

    Dr. Scarlett added, "We reported clinically meaningful transfusion independence with longer durability from more mature data in the IMerge Phase 2 trial in lower risk MDS, which included 29% of patients being transfusion-free for more than one year. We also raised additional capital in the second quarter that we expect will sufficiently fund our development plans for the ongoing Phase 3 IMerge trial in lower risk MDS and the upcoming Phase 3 trial in refractory MF into the second half of 2022. These achievements, along with our experienced development team, position Geron to become a leader in the treatment of hematologic myeloid malignancies over the next several years."

    Current Events – Clinical Development and Regulatory

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

    As of the end of July 2020, approximately 93% of the 90 clinical sites originally planned for the trial were open for screening and enrollment, compared to 68% in May.

    The momentum of patient enrollment has begun to improve as the effects of the COVID-19 pandemic begin to wane in a majority of the countries where IMerge clinical sites are located. The Company continues to expect patient enrollment to be completed by the end of the first quarter of 2021, subject to potential future delays or interruptions associated with COVID-19. To help ensure achievement of this goal, the trial is being expanded from 90 to approximately 130 clinical sites. Geron expects a majority of these 40 new sites to be open for enrollment by the end of the year. Under current enrollment assumptions, the Company continues to expect top-line results in the second half of 2022.

    Start-Up Activities for Planned Phase 3 Clinical Trial in Myelofibrosis (MF)

    Geron expects to engage over 150 sites across North America, South America, Europe and Asia to participate in the planned global Phase 3 clinical trial in refractory MF. Trial start-up activities underway include identifying potential clinical sites for participation, as well as finalizing the clinical trial protocol. Geron plans to open the trial for screening and enrollment in the first quarter of 2021. Under current planning assumptions, Geron expects to complete patient enrollment in the second half of 2022, to conduct an interim analysis in the first half of 2023 and to conduct a final analysis in the first half of 2024.

    European Commission Grants Orphan Drug Designation to Imetelstat for MDS

    At the end of July, the European Commission granted orphan drug designation to imetelstat as a potential treatment for MDS based on a positive opinion from the European Medicines Agency Committee for Orphan Medicinal Products. Imetelstat has already been granted orphan drug designation by the United States Food and Drug Administration as a potential treatment for MDS.

    Recent Data Presentations in June

    KOL Event Highlighted Compelling Phase 2 Data from the European Hematology Association (EHA) Annual Congress

    Key opinion leaders within hematologic myeloid malignancies reprised four presentations containing new clinical data and analyses related to imetelstat from the Virtual Edition of the EHA Annual Congress.

    The recent EHA presentation of more mature data from 38 patients in the IMerge Phase 2 clinical trial in lower risk MDS reported notable continued durability, including a median duration of 8-week transfusion independence of 20 months, which is the longest duration reported to date in this trial. Also reported for the first time, 29% of the 38 patients were transfusion free for more than one year.

    In addition, new analyses from the IMbark Phase 2 clinical trial in relapsed/refractory MF correlated the median overall survival observed in the trial with other clinical endpoints, such as improvement in fibrosis. These analyses provide further support for the planned Phase 3 clinical trial in refractory MF.

    Overall, the EHA data and analyses continue to support the potential disease-modifying activity with imetelstat treatment as evidenced by the clinically meaningful durable transfusion independence in the Phase 2 IMerge trial and the improvement in overall survival in the Phase 2 IMbark trial.

    Strengthened Balance Sheet to Achieve Development Plans

    As of June 30, 2020, Geron had approximately $265 million in cash, cash equivalents, and current and non-current marketable securities. The Company's cash position reflects net proceeds of approximately $140 million from a public offering of securities in the second quarter. Based on current planning assumptions, the Company expects such funds to be sufficient for its operations into the second half of 2022 when top-line results for the IMerge Phase 3 clinical trial in lower risk MDS and completion of patient enrollment for the planned Phase 3 clinical trial in refractory MF are expected.

    Second Quarter and Year-to-Date 2020 Results

    For the second quarter of 2020, the Company reported a net loss of $15.8 million, or $0.06 per share, compared to $14.2 million, or $0.08 per share, for the comparable 2019 period. Net loss for the first six months of 2020 was $32.2 million, or $0.14 per share, compared to $24.3 million, or $0.13 per share, for the comparable 2019 period.

    Revenues for the three and six months ended June 30, 2020 were $43,000 and $95,000, respectively, compared to $101,000 and $158,000 for the comparable 2019 periods. Revenues in 2020 and 2019 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 future product sales.

    Total operating expenses for the three and six months ended June 30, 2020 were $16.8 million and $33.7 million, respectively, compared to $15.3 million and $26.7 million for the comparable 2019 periods.

    Research and development expenses for the three and six months ended June 30, 2020 were $10.8 million and $21.6 million, respectively, compared to $10.1 million and $16.0 million for the comparable 2019 periods. The increase in research and development expenses for the three and six months ended June 30, 2020, compared to the same periods in 2019, primarily reflects higher clinical development costs associated with the IMerge Phase 3 clinical trial, increased costs in connection with validating the imetelstat manufacturing process at contract manufacturers and higher personnel-related costs for additions to the development team in 2019.

    General and administrative expenses for the three and six months ended June 30, 2020 were $6.0 million and $12.1 million, respectively, compared to $5.2 million and $10.6 million for the comparable 2019 periods. The increase in general and administrative expenses for the three and six months ended June 30, 2020, compared to same periods in 2019, primarily reflects increased personnel-related expenses for additional general and administrative headcount to support growing operational activities.

    Interest and other income for the three and six months ended June 30, 2020 was $475,000 and $1.2 million, respectively, compared to $1.1 million and $2.3 million for the comparable 2019 periods. The decrease in interest and other income for the three and six months ended June 30, 2020, compared to same periods in 2019, primarily reflects lower yields on the Company's reduced marketable securities portfolio.

    2020 Financial Guidance Reaffirmed

    The Company expects its 2020 operating expense burn to range from $70 to $75 million. This guidance reflects cash conservation measures implemented in April due to the COVID-19 pandemic, such as suspending travel and postponing a planned imetelstat proof of concept study. It also reflects new costs for start-up activities associated with the planned Phase 3 clinical trial in refractory MF and additional costs for the expansion of clinical sites for the IMerge Phase 3 clinical trial.

    Conference Call

    Geron will host a conference call at 4:30 p.m. ET on Thursday, August 6, 2020 to discuss second quarter financial results and recent events.

    A live, listen-only webcast will be available on the Company's website at www.geron.com/investors/events. If you are unable to listen to the live call, an archived webcast will be available on the Company's website for 30 days.

    Participants may access the conference call live via telephone by dialing domestically +1 (888) 869-1189 or internationally +1 (706) 643-5902. The conference ID is 8496138. To minimize potential registration and access delays, Geron has implemented Direct Event, which allows participants to pre-register online using the following link, http://www.directeventreg.com/registration/event/8496138. Upon registration, a Direct Event Passcode and unique Registrant ID will be sent via email and 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. 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 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 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. 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) the therapeutic potential of imetelstat, including imetelstat's potential survival benefit for refractory MF patients; (ii) that for the planned Phase 3 clinical trial in refractory MF, Geron expects to begin patient screening and enrollment in the first quarter of 2021, complete patient enrollment in the second half of 2022, conduct an interim analysis in the first half of 2023 and conduct a final analysis in the first half of 2024; (iii) that imetelstat may have disease-modifying activity; (iv) that the Company has sufficient finances to fund IMerge and the planned refractory MF clinical trial into the second half of 2022; (v) that for IMerge, Geron expects to complete enrollment in the first quarter of 2021 and have top-line results in the second half of 2022; (vi) that Geron's 2020 operating expense range will be $70-75 million; and (vii) 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 clinical, safety, efficacy, technical, scientific, intellectual property, manufacturing and regulatory challenges in order to meet the expected timelines and planned milestones in (ii), (iv) and (v) 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 clinical trials; (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 imetelstat is able to maintain patent protection and have freedom to operate; (h) Geron's 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 (ii), (iv) and (v) above; (i) whether there are cost overruns in 2020 due to the current or evolving effects of the COVID-19 pandemic or otherwise; (j) whether Geron can accurately project the timing of, or attain complete enrollment in IMerge, the planned Phase 3 refractory MF trial or of any potential future clinical trials of imetelstat, whether due to the current or evolving effects of the COVID-19 pandemic or otherwise; and (k) whether there are failures or delays in manufacturing 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. 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 June 30, 2020 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

     

    Six Months Ended

     

    June 30,

     

    June 30,

    (In thousands, except share and per share data)

    2020

     

    2019

     

    2020

     

    2019

     

     

     

     

     

    Revenues:

     

     

     

     

    License fees and royalties

    $

    43

    $

    101

    $

    95

    $

    158

     

     

     

     

     

     

     

     

     

    Operating expenses:

     

     

     

     

     

     

     

     

    Research and development

     

    10,845

     

    10,134

     

    21,647

     

    16,040

    General and administrative

     

    5,960

     

    5,191

     

    12,080

     

    10,643

    Total operating expenses

     

    16,805

     

    15,325

     

    33,727

     

    26,683

    Loss from operations

     

    (16,762)

     

    (15,224)

     

    (33,632)

     

    (26,525)

     

     

     

     

     

     

     

     

     

    Interest and other income

     

    475

     

    1,113

     

    1,229

     

    2,275

    Change in fair value of equity investment

     

    422

     

    (98)

     

    227

     

    Other expense

     

    41

     

    (30)

     

    (3)

     

    (48)

    Net loss

    $

    (15,824)

    $

    (14,239)

    $

    (32,179)

    $

    (24,298)

     

     

     

     

     

     

     

     

     

    Basic and diluted net loss per share:

     

     

     

     

     

     

     

     

    Net loss per share

    $

    (0.06)

    $

    (0.08)

    $

    (0.14)

    $

    (0.13)

    Shares used in computing net loss per share

     

    246,966,143

     

    186,556,082

     

    223,594,118

     

    186,475,055

    CONDENSED BALANCE SHEETS

     

     

     

     

    June 30,

     

    December 31,

    (In thousands)

    2020

     

    2019

     

    (Unaudited)

     

    (Note 1)

    Current assets:

     

     

    Cash, cash equivalents and restricted cash

    $

    23,228

    $

    13,914

    Current marketable securities

     

    195,881

     

    125,681

    Other current assets

     

    1,634

     

    2,013

    Total current assets

     

    220,743

     

    141,608

     

     

     

    Noncurrent marketable securities

     

    46,223

     

    19,651

    Property and equipment, net

     

    734

     

    408

    Other assets

     

    7,114

     

    3,850

     

    $

    274,814

    $

    165,517

     

     

     

    Current liabilities

    $

    19,142

    $

    28,162

    Noncurrent liabilities

     

    4,991

     

    2,200

    Stockholders' equity

     

    250,681

     

    135,155

     

    $

    274,814

    $

    165,517

    Note 1:

    Derived from audited financial statements included in the Company's annual report on Form 10-K for the year ended December 31, 2019.

     

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  33. Geron Corporation (NASDAQ:GERN), a late-stage clinical biopharmaceutical company, today announced that John A. Scarlett, M.D., Chairman and Chief Executive Officer, will participate in a fireside chat at the BTIG Virtual Biotechnology Conference on Tuesday, August 11, 2020 at 12:30 p.m. ET.

    A live audio webcast of the presentation will be available on Geron's website, www.geron.com/investors/events. If you are unable to listen to the live presentation, an archived webcast will be available on the Company's website for 30 days.

    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…

    Geron Corporation (NASDAQ:GERN), a late-stage clinical biopharmaceutical company, today announced that John A. Scarlett, M.D., Chairman and Chief Executive Officer, will participate in a fireside chat at the BTIG Virtual Biotechnology Conference on Tuesday, August 11, 2020 at 12:30 p.m. ET.

    A live audio webcast of the presentation will be available on Geron's website, www.geron.com/investors/events. If you are unable to listen to the live presentation, an archived webcast will be available on the Company's website for 30 days.

    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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  34. Geron Corporation (NASDAQ:GERN) today announced that it will release its second quarter 2020 financial results after the market closes on Thursday, August 6, 2020 via press release, which will be available on the Company's website at www.geron.com/investors. Geron will host a conference call to discuss the financial results as well as recent events at 4:30 p.m. ET the same day.

    A live, listen-only webcast will be available on the Company's website at www.geron.com/investors/events. If you are unable to listen to the live call, an archived webcast will be available on the Company's website for 30 days.

    Participants may access the conference call live via telephone by dialing domestically +1 (888) 869-1189 or internationally +1 (706) 643-5902…

    Geron Corporation (NASDAQ:GERN) today announced that it will release its second quarter 2020 financial results after the market closes on Thursday, August 6, 2020 via press release, which will be available on the Company's website at www.geron.com/investors. Geron will host a conference call to discuss the financial results as well as recent events at 4:30 p.m. ET the same day.

    A live, listen-only webcast will be available on the Company's website at www.geron.com/investors/events. If you are unable to listen to the live call, an archived webcast will be available on the Company's website for 30 days.

    Participants may access the conference call live via telephone by dialing domestically +1 (888) 869-1189 or internationally +1 (706) 643-5902. The conference ID is 8496138. To minimize potential registration and access delays, Geron has implemented Direct Event, which allows participants to pre-register online using the following link, http://www.directeventreg.com/registration/event/8496138. Upon registration, a Direct Event Passcode and unique Registrant ID will be sent via email and 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 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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  35. Geron Corporation (NASDAQ:GERN) today reported that it has granted a non-statutory stock option to purchase an aggregate of 150,000 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 July 15, 2020 at an exercise price of $2.04 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 Corporation (NASDAQ:GERN) today reported that it has granted a non-statutory stock option to purchase an aggregate of 150,000 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 July 15, 2020 at an exercise price of $2.04 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 a material inducement to employment in accordance with Nasdaq Listing Rule 5635(c)(4) and is subject to the terms and conditions of a 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 myeloid malignancies. For more information about Geron, visit www.geron.com.

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    • 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…

    • 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.

    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) IMerge, Geron expects to complete enrollment in the first quarter of 2021 and have top-line results in the second half of 2022; (ii) that data from the IMerge Phase 3 clinical trial will support global regulatory filings; (iii) the period of potential market exclusivity in the EU with orphan drug designation; (iv) potential disease-modifying activity of imetelstat; (v) that the European Commission will grant the orphan drug designation; and (vi) 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 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 evolving effects of the COVID-19 pandemic, and overcomes the clinical, safety, efficacy, technical, scientific, intellectual property, manufacturing and regulatory challenges in order to meet the expected timelines and planned milestones in (i) 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 clinical trials; (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) Geron's 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 (i) above; (h) whether Geron can accurately project or attain complete enrollment in the IMerge Phase 3 clinical trial, whether due to the evolving effects of the COVID-19 pandemic or otherwise; (i) whether EU regulatory authorities in the future decide that there are other drugs so similar to imetelstat that its orphan drug designation is not warranted and removed; and (j) whether there are failures or delays in manufacturing sufficient quantities of imetelstat or other clinical trial materials in a timely manner, whether due to the evolving effects of the COVID-19 pandemic or otherwise. 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, 2020. 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.

    CONTACT:

    Suzanne Messere

    Investor and Media Relations

    investor@geron.com

    media@geron.com 

    Primary Logo

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    • For the IMerge Phase 2 clinical trial, meaningful and durable transfusion independence reported with a new 1-year TI rate, indicating potential disease-modifying activity of imetelstat treatment
    • For the IMbark Phase 2 clinical trial, the analyses correlate the potential improvement in overall survival from imetelstat treatment with other clinical benefits observed in the trial, such as fibrosis improvement, as well as symptom and spleen response
    • Data provide further support of ongoing and planned Phase 3 clinical trials of imetelstat

    MENLO PARK, Calif., June 12, 2020 (GLOBE NEWSWIRE) -- Geron Corporation (NASDAQ:GERN), a late-stage clinical biopharmaceutical company, today announced that an oral presentation and three poster presentations of…

    • For the IMerge Phase 2 clinical trial, meaningful and durable transfusion independence reported with a new 1-year TI rate, indicating potential disease-modifying activity of imetelstat treatment

    • For the IMbark Phase 2 clinical trial, the analyses correlate the potential improvement in overall survival from imetelstat treatment with other clinical benefits observed in the trial, such as fibrosis improvement, as well as symptom and spleen response
    • Data provide further support of ongoing and planned Phase 3 clinical trials of imetelstat

    MENLO PARK, Calif., June 12, 2020 (GLOBE NEWSWIRE) -- Geron Corporation (NASDAQ:GERN), a late-stage clinical biopharmaceutical company, today announced that an oral presentation and three 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 Virtual Edition of the 25th Annual EHA Annual Congress.   

    Updated Efficacy and Safety Data from IMerge Phase 2 Clinical Trial in Lower Risk Myelodysplastic Syndromes (MDS)

    "The EHA presentation reports encouraging continued durability data from the IMerge Phase 2 clinical trial, including a median duration of 8-week transfusion independence of 20 months, which is the longest duration we have reported to date in this trial, and that 29% of patients were transfusion free for more than one year," said Aleksandra Rizo, M.D., Ph.D., Geron's Chief Medical Officer. "We expect these data to drive further interest of investigators, which will promote enrollment for the ongoing IMerge Phase 3 clinical trial in lower risk MDS."   

    Title: Treatment with Imetelstat Provides Durable Transfusion Independence (TI) in Heavily Transfused Non-del(5q) Lower Risk MDS (LR-MDS) Relapsed/Refractory (R/R) to Erythropoiesis Stimulating Agents (ESAs) (Abstract #S183)

    The oral presentation reports long-term efficacy and safety data from 38 patients in the IMerge Phase 2 clinical trial, based on a February 4, 2020 cut-off date and a median follow-up of 24 months. IMerge is a two-part Phase 2/3 clinical trial evaluating imetelstat in transfusion dependent patients with Low or Intermediate-1 risk myelodysplastic syndromes (lower risk MDS), who are relapsed after or refractory to prior treatment with ESAs. The first part of IMerge was designed as a Phase 2, open label, single arm study to assess the efficacy and safety of imetelstat. The primary efficacy endpoint is 8-week TI rate, which is defined as the proportion of patients achieving red blood cell transfusion independence during any consecutive eight weeks since entry into the trial. Secondary endpoints include rate of hematologic improvement-erythroid (HI-E) and duration of TI. Several patients remain on treatment in the IMerge Phase 2 clinical trial.

    The conclusions of the oral presentation are as follows:

    • Meaningful and durable transfusion independence (TI):

      ° High rates of TI and HI-E: 42% 8-week TI rate and 68% HI-E rate

      ° Durable TI and HI-E: Median duration of TI is 20 months and median duration of HI-E is 21 months

      ° TI across multiple patient subtypes: ringed sideroblast positive (RS+) and RS-, high and very high transfusion burden



    • Potential disease-modifying activity:

      ° 29% of patients transfusion free for more than 1 year

      ° 75% of 8-week TI responders had a hemoglobin rise of > 3g/dL from pretreatment level

      ° Reduction in variant allele frequency (VAF) of SF3B1 mutation correlated with shorter time to TI and duration of TI



    • No new safety signal identified:

      ° Reversible cytopenias, without significant clinical consequences were most frequent adverse events

    The slide presentation is available on Geron's website at www.geron.com/r-d/publications.

    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). The trial was opened for screening and enrollment in August 2019. As of the end of April 2020, approximately 68% of planned clinical sites for the IMerge Phase 3 trial were open for enrollment. Geron expects to complete patient enrollment by the end of the first quarter of 2021. Under current assumptions, the Company expects top-line results to be available in the second half of 2022.

    New Analyses of Data from IMbark Phase 2 Clinical Trial in Intermediate-2 or High-risk Myelofibrosis

    "Taken together, we believe the three EHA poster presentations reporting new analyses of IMbark Phase 2 data substantiate the OS outcome observed in IMbark and indicate potential disease-modifying activity of imetelstat in yet another hematologic indication," said Aleksandra Rizo, M.D., Ph.D., Geron's Chief Medical Officer. "These analyses also provide further support for our planned Phase 3 clinical trial in refractory MF, which is expected to open for enrollment in the first quarter of 2021."

    IMbark was designed as a Phase 2 clinical trial to evaluate two dosing regimens of imetelstat (either 4.7 mg/kg or 9.4 mg/kg administered by intravenous infusion every three weeks) in patients with Intermediate-2 or High-risk myelofibrosis (MF) who have relapsed after or are refractory to prior treatment with a janus kinase inhibitor (JAKi). The co-primary efficacy endpoints for IMbark were spleen response rate, defined as the proportion of patients who achieve a reduction of at least 35% in spleen volume as assessed by imaging, and symptom response rate, defined as the proportion of patients who achieve a reduction of at least 50% in Total Symptom Score (TSS), at 24 weeks. Key secondary endpoints were overall survival (OS) and safety.

    Title: Telomerase Activity, Telomere Length and hTERT Expression Correlate with Clinical Outcomes in Higher-Risk Myelofibrosis (MF) Relapsed/Refractory (R/R) to Janus Kinase Inhibitor Treated with Imetelstat (Abstract #EP1098)

    The conclusions of the poster are as follows:

    • Imetelstat achieved dose- and exposure-dependent reduction of telomerase activity and human reverse transcriptase (hTERT) expression level, demonstrating on-target mechanism of action.
    • Achieving optimal pharmacodynamic (PD) effect in patients treated with imetelstat is correlated with longer OS, as well spleen and symptom response.
    • Significant dose-dependent reduction in VAF of JAK2, CALR and MPL mutations were observed, indicating that imetelstat has disease-modifying activity by targeting the underlying MF malignant clones.
    • Treatment with 9.4mg/kg of imetelstat improved clinical outcomes in patients with short telomeres or high hTERT expression level at baseline. The results are consistent with telomere biology in cancer cells and provide evidence for on-target mechanism of action of imetelstat through telomerase inhibition. 
    • This is the first clinical report to systematically evaluate the mechanism of action based PD effect of imetelstat, and its relationship to exposure and clinical benefits.

    The poster presentation is available on Geron's website at www.geron.com/r-d/publications.

    Title: Imetelstat Treatment Results in Clinical Benefits, Including Improved Overall Survival, in Patients with Higher-Risk Triple Negative Myelofibrosis Relapsed/Refractory to Janus Kinase Inhibitors (JAKI) (Abstract #1101)

    The overall conclusion of the poster is that triple negative (TN) patients who are relapsed/refractory to JAKi and treated with 9.4 mg/kg of imetelstat had better clinical outcomes and prolonged overall survival (OS) compared to non-TN patients, suggesting that imetelstat may improve the poor outcomes expected for TN patients. Additional highlights from the poster include:

    • With 9.4 mg/kg of imetelstat treatment, clinical response rates were higher in TN vs non-TN pts: spleen response rate was 18.8% in TN vs 7.3% in non-TN; and symptom response was 50.0% in TN vs 24.4% in non-TN patients.
    • Imetelstat treatment at 9.4 mg/kg resulted in significantly longer median OS of 35.9 months for TN patients compared to 24.6 months for non-TN patients.
    • A majority (94%) of the TN patients enrolled on the study had grade three fibrosis. Higher rate of bone marrow fibrosis improvement was noted in the TN (50%) vs non-TN (39.1%) patients.
    • TN patients enrolled on the study had short telomere length and high hTERT expression level at baseline, representing a suitable target population for imetelstat, a first-in-class telomerase inhibitor.

    The poster presentation is available on Geron's website at www.geron.com/r-d/publications.

    Title: Favorable Overall Survival with Imetelstat Treatment Correlates with Other Clinical Benefits in Intermediate-2 or High-Risk Myelofibrosis Relapsed/Refractory to Janus Kinase Inhibitor (Abstract #1107)

    The poster reports new analyses of data from all 107 patients in both arms (59 patients in the 9.4 mg/kg arm and 48 patients in the 4.7 mg/kg arm) of the IMbark Phase 2 clinical trial with a data cut-off date of February 19, 2020 and a median follow-up of 41.7 months. As of the data cut-off date, median OS was 28.1 months in the 9.4 mg/kg arm and 19.9 months in the 4.7 mg/kg arm.

    The overall conclusion of the poster was that imetelstat showed dose-related improvement in OS in patients who are R/R to JAKi. The survival benefit observed with imetelstat was supported by the trend of correlation with other clinical benefits. Additional highlights from the poster include:

    • Among 57 patients across both treatment arms that had matching bone marrow samples, 20 patients (35%) had ≥1 degree of bone marrow fibrosis improvement while on study and had a significantly longer OS than those who had worsening bone marrow fibrosis. A similar trend was seen in 29 patients (51%) with stable vs. worsening fibrosis.
    • Patients who achieved symptom and spleen response at week 24 showed a trend of longer OS compared to patients who did not achieve response.
    • Transfusion dependency, response to last JAKi, higher baseline neutrophils, lower baseline hemoglobin and platelet values correlated with increased risk of death.

    The poster presentation is available on Geron's website at www.geron.com/r-d/publications.

    Planned Phase 3 Clinical Trial in Refractory MF

    The planned Phase 3 clinical trial in refractory MF is designed to be an open label 2:1 randomized, controlled trial with registration intent to evaluate imetelstat (9.4 mg/kg administered by intravenous infusion every three weeks) in approximately 320 patients with Intermediate-2 or High-risk MF. Patients eligible for the trial will be required to be refractory to a JAK inhibitor, an inclusion criterion that is planned to be defined as having an inadequate spleen response or symptom response after treatment with a JAK inhibitor for at least six months, including an optimal dose of a JAK inhibitor for at least two months. The control arm is planned to be best available therapy (BAT), excluding JAK inhibitors. The primary efficacy endpoint for the trial is planned to be overall survival (OS). Planned 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. Under current assumptions, the Company expects to complete patient enrollment in the second half of 2022, to conduct an interim analysis in the first half of 2023 and to conduct a final analysis in the first half of 2024. The final analysis for OS is planned to be conducted after more than 50% of the patients planned to be enrolled in the trial have died. An interim analysis of OS is planned to be conducted after approximately 70% of the total projected number of events for the final analysis have occurred. Both the planned interim and final analyses are event driven and could occur on different timelines than currently expected.

    Event with Key Opinion Leaders to Discuss EHA Presentations

    On June 17, 2020, Geron will be hosting a webcasted event with authors from each respective data presentation from the EHA Annual Congress who will reprise the presentations from EHA. A live, listen-only webcast will be available on the Company's website at www.geron.com/investors/events. If you are unable to listen to the live call, an archived webcast will be available on the Company's website for 30 days.

    Participants may access the conference call live via telephone by dialing domestically +1 (833) 513-0551 or internationally +1 (647) 689-4209. The conference ID is 1988213.

    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.

    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) the therapeutic potential of imetelstat, including imetelstat's potential survival benefit for refractory MF patients; (ii) that for the planned Phase 3 clinical trial in refractory MF, Geron expects to begin patient enrollment in the first quarter of 2021, complete patient enrollment in the second half of 2022, conduct an interim analysis in the first half of 2023 and conduct a final analysis in the first half of 2024; (iii) the design, commencement and conduct of the planned Phase 3 clinical trial in refractory MF; (iv) that imetelstat may have disease-modifying activity; (v) that for IMerge, Geron expects to complete enrollment in the first quarter of 2021 and have top-line results in the second half of 2022; (vi) IMerge's design, including that IMerge will potentially demonstrate durable transfusion independence; and (vii) 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 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 evolving effects of the COVID-19 pandemic, and overcomes the clinical, safety, efficacy, technical, scientific, intellectual property, manufacturing and regulatory challenges in order to meet the expected timelines and planned milestones in (ii) and (v) 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 clinical trials; (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) Geron's 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 (ii) and (v) above; (h) whether Geron can accurately project or attain complete enrollment in IMerge, the planned Phase 3 refractory MF trial or any potential future clinical trials of imetelstat, whether due to the evolving effects of the COVID-19 pandemic or otherwise; and (i) whether there are failures or delays in manufacturing sufficient quantities of imetelstat or other clinical trial materials in a timely manner, whether due to the evolving effects of the COVID-19 pandemic or otherwise. 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, 2020. 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.

    CONTACT:

    Suzanne Messere

    Investor and Media Relations

    investor@geron.com

    media@geron.com

    CG Capital

    887-889-1972

    Primary Logo

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  36. MENLO PARK, Calif., May 28, 2020 (GLOBE NEWSWIRE) -- Geron Corporation (NASDAQ:GERN) today reported financial results for the first quarter ended March 31, 2020. The Company will host a conference call today at 4:30 p.m. ET to discuss the recently announced planned Phase 3 clinical trial in refractory MF, as well as an update on the ongoing IMerge Phase 3 clinical trial in lower risk MDS and first quarter financial results.

    Financial Resources

    As of March 31, 2020, Geron had approximately $133 million in cash, cash equivalents, and current and non-current marketable securities. Based on current planning assumptions, the Company estimates these financial resources, combined with the estimated net proceeds of approximately $140 million from…

    MENLO PARK, Calif., May 28, 2020 (GLOBE NEWSWIRE) -- Geron Corporation (NASDAQ:GERN) today reported financial results for the first quarter ended March 31, 2020. The Company will host a conference call today at 4:30 p.m. ET to discuss the recently announced planned Phase 3 clinical trial in refractory MF, as well as an update on the ongoing IMerge Phase 3 clinical trial in lower risk MDS and first quarter financial results.

    Financial Resources

    As of March 31, 2020, Geron had approximately $133 million in cash, cash equivalents, and current and non-current marketable securities. Based on current planning assumptions, the Company estimates these financial resources, combined with the estimated net proceeds of approximately $140 million from the recently closed public offering of securities, provide sufficient funds for the Company's operations into the second half of 2022 when top-line results for the IMerge Phase 3 clinical trial in lower risk myelodysplastic syndromes (MDS) are expected, as well completion of patient enrollment for the planned Phase 3 clinical trial in refractory myelofibrosis (MF).

    Revised 2020 Guidance

    The Company expects its 2020 operating expense burn to range from $70 to $75 million. This guidance reflects cash conservation measures implemented in April due to the COVID-19 pandemic, such as suspending travel and postponing a planned imetelstat proof of concept study. It also reflects new costs for startup activities associated with the planned Phase 3 clinical trial in refractory MF and additional costs for the expansion of clinical sites for the IMerge Phase 3 clinical trial.  

    First Quarter 2020 Results

    For the first quarter of 2020, the Company reported a net loss of $16.4 million, or $0.08 per share, compared to $10.1 million, or $0.05 per share, for the comparable 2019 period.

    Revenues for the first quarter of 2020 were $52,000 compared to $57,000 for the comparable 2019 period. Royalty revenues in 2020 and 2019 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 future product sales.

    Total operating expenses for the first quarter of 2020 were $16.9 million compared to $11.4 million for the comparable 2019 period.

    Research and development expenses for the first quarter of 2020 were $10.8 million compared to $5.9 million for the comparable 2019 period. The increase in research and development expenses, compared to the same period in 2019, primarily reflects higher clinical development costs associated with the IMerge Phase 3 clinical trial and higher personnel-related costs for the additions to the development team in 2019.

    General and administrative expenses for the first quarter of 2020 were $6.1 million compared to $5.5 million for the comparable 2019 period. The increase in general and administrative expenses in the first quarter of 2020 compared to same period in 2019 primarily reflects increased personnel-related expenses for additional general and administrative headcount to support growing operational activities.

    Interest and other income for the first quarter of 2020 was $0.8 million compared to $1.2 million for the comparable 2019 period. The decrease in interest and other income for 2020 compared to 2019 primarily reflects lower yields on the Company's reduced marketable securities portfolio.

    Conference Call

    Geron will host a conference call at 4:30 p.m. ET on Thursday, May 28, 2020 to discuss the planned Phase 3 clinical trial in refractory MF, as well as an update on the ongoing IMerge Phase 3 clinical trial in lower risk MDS and first quarter financial results.

    Participants may access the conference call live via telephone by dialing domestically +1 (833) 513-0551 or internationally +1 (647) 689-4209. The conference ID is 5582655. A live, listen-only webcast will also be available on the Company's website at www.geron.com/investors/events. If you are unable to listen to the live call, an archived webcast will be available on the Company's website for 30 days.

    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 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 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. 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 the Company estimates its financial resources, combined with the estimated net proceeds of approximately $140 million from the recently closed public offering of securities, provide sufficient funds for the Company's operations into the second half of 2022 when top-line results for the IMerge Phase 3 clinical trial in lower risk myelodysplastic syndromes (MDS) are expected, as well completion of patient enrollment for the planned Phase 3 clinical trial in refractory MF; (ii) that the Company expects its 2020 operating expense burn to range from $70 to $75 million; (iii) that the Company has planned a Phase 3 clinical trial in refractory MF and that is expected to be open for patient screening and enrollment in the first quarter of 2021; (iv) that imetelstat may have disease-modifying activity; and (v) 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: (i) whether the COVID pandemic slows or prohibits the Company's ability to have top-line results from the IMerge Phase 3 clinical trial in the second half of 2022, the screening and enrollment of patients into the planned Phase 3 clinical trial in refractory MF in the first quarter of 2021 and/or the completion of patient enrollment for the planned Phase 3 clinical trial in refractory MF in the second half of 2022; (ii) whether regulatory authorities permit the further development of imetelstat on a timely basis, or at all, without any clinical holds; (iii) whether imetelstat is safe and efficacious, and whether any future efficacy or safety results may cause the benefit-risk profile of imetelstat to become unacceptable; (iv) the need for future capital; and (v) whether imetelstat demonstrates disease-modifying activity in clinical trials. 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, 2020. 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) 2020    2019
                 
    Revenues:            
    License fees and royalties $   52     $   57  
                 
    Operating expenses:            
    Research and development     10,802         5,906  
    General and administrative     6,120         5,452  
    Total operating expenses     16,922         11,358  
    Loss from operations     (16,870 )       (11,301 )
                 
    Interest and other income     754         1,162  
    Change in fair value of equity investment     (195 )       98  
    Other expense     (44 )       (18 )
    Net loss $   (16,355 )   $   (10,059 )
                 
    Basic and diluted net loss per share:            
    Net loss per share $   (0.08 )   $   (0.05 )
    Shares used in computing net loss per share   200,222,092       186,393,128  
                   


    CONDENSED BALANCE SHEETS
     
      March 31,   December 31,
    (In thousands)  2020   2019
      (Unaudited)   (Note 1)
    Current assets:        
    Cash, cash equivalents and restricted cash $     20,564   $     13,914
    Current marketable securities     111,822       125,681
    Other current assets       1,769         2,013
    Total current assets     134,155       141,608
             
    Noncurrent marketable securities     1,029       19,651
    Property and equipment, net     749       408
    Deposits and other assets       6,956         3,850
      $     142,889   $     165,517
             
    Current liabilities $     16,916   $     28,162
    Noncurrent liabilities     5,159     2,200
    Stockholders' equity       120,814         135,155
      $     142,889   $     165,517
     

    Note 1: Derived from audited financial statements included in the Company's annual report on Form 10-K for the year ended December 31, 2019.  


    CONTACT:

    Suzanne Messere
    Investor and Media Relations
    investor@geron.com
    media@geron.com

    CG Capital
    877-889-1972

     

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  37. MENLO PARK, Calif., May 27, 2020 (GLOBE NEWSWIRE) -- Geron Corporation (NASDAQ:GERN), a late-stage clinical biopharmaceutical company, today announced the closing of its previously announced underwritten public offering of 107,049,375 shares of its common stock and pre-funded warrants to purchase 8,335,239 shares of common stock, together with accompanying warrants to purchase 57,692,307 shares of common stock. The common stock and pre-funded warrants were sold in combination with an accompanying warrant to purchase 0.5 of a share of common stock issued for each share of common stock or pre-funded warrant sold. The combined offering price to the public of each share of common stock and accompanying warrant was $1.30. The combined offering…

    MENLO PARK, Calif., May 27, 2020 (GLOBE NEWSWIRE) -- Geron Corporation (NASDAQ:GERN), a late-stage clinical biopharmaceutical company, today announced the closing of its previously announced underwritten public offering of 107,049,375 shares of its common stock and pre-funded warrants to purchase 8,335,239 shares of common stock, together with accompanying warrants to purchase 57,692,307 shares of common stock. The common stock and pre-funded warrants were sold in combination with an accompanying warrant to purchase 0.5 of a share of common stock issued for each share of common stock or pre-funded warrant sold. The combined offering price to the public of each share of common stock and accompanying warrant was $1.30. The combined offering price to the public of each pre-funded warrant and accompanying warrant was $1.299.

    The estimated net proceeds to Geron from the public offering are expected to be approximately $140 million, after deducting the underwriting discount and estimated offering expenses payable by Geron. Geron intends to use the net proceeds from this public offering to fund its ongoing IMerge Phase 3 clinical trial in lower risk myelodysplastic syndromes to top-line results, its planned Phase 3 clinical trial in refractory myelofibrosis to complete patient enrollment, and for working capital and general corporate purposes.

    Stifel and MTS Health Partners acted as joint book-running managers for the offering. Needham & Company, BTIG and H.C. Wainwright & Co. acted as co-managers for the offering.

    A shelf registration statement on Form S-3 relating to the public offering of the shares of common stock and accompanying warrants described above was previously filed with the Securities and Exchange Commission (SEC) and subsequently declared effective by the SEC. A final prospectus supplement relating to the offering has been filed with the SEC and is available on the SEC's web site at www.sec.gov. Copies of the final prospectus supplement may also be obtained from Stifel, Nicolaus & Company, Incorporated, Attention: Syndicate, One Montgomery Street, Suite 3700, San Francisco, California 94104, by telephone at 415-364-2720 or by email at syndprospectus@stifel.com; or MTS Securities, LLC, 623 Fifth Avenue, 14th Floor, New York, New York 10022, by telephone at 646-975-6548 or by email at tamirisa@mtspartners.com.

    This press release does not constitute an offer to sell or the solicitation of an offer to buy any of these securities, nor will there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

    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.

    Use of Forward-Looking Statements

    Investors are cautioned that statements in this press release regarding the anticipated net proceeds from the offering and Geron's intended use of the net proceeds from this public offering constitute forward-looking statements that involve risks and uncertainties, including, without limitation, risks and uncertainties related to: higher than estimated offering expenses; market and other conditions; the impact of general economic, industry or political conditions in the United States or internationally, including the impact of the COVID-19 pandemic on our business operations and activities; and the customary risks and uncertainties that biotechnology companies in the pre-commercial development phase face. If any of these risk and uncertainties were to occur, it would force Geron to delay, reduce or terminate its imetelstat clinical development program, which would have a material adverse effect on Geron's business, operations and stock price. Actual results may differ materially from the results anticipated in these forward-looking statements. Additional information on other potential factors that could affect Geron's results and other risks and uncertainties can be found under the heading "Risk Factors" in Geron's periodic reports, including its Annual Report on Form 10-K for the year ended December 31, 2019, and in the final prospectus supplement related to the public offering filed with the SEC on May 26, 2020 available on the SEC's web site at www.sec.gov. Geron expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in its expectations with regard thereto or any change in events, conditions or circumstances on which any such statements are based.

    CONTACT:

    Suzanne Messere
    Investor and Media Relations
    investor@geron.com
    media@geron.com

    CG Capital
    877-889-1972

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  38. MENLO PARK, Calif., May 22, 2020 (GLOBE NEWSWIRE) -- Geron Corporation (NASDAQ:GERN), a late-stage clinical biopharmaceutical company, today announced the pricing of its previously announced underwritten public offering of 107,049,375 shares of its common stock and pre-funded warrants to purchase 8,335,239 shares of common stock, together with accompanying warrants to purchase 57,692,307 shares of common stock. The common stock and pre-funded warrants will be sold in combination with an accompanying warrant to purchase 0.5 of a share of common stock issued for each share of common stock or pre-funded warrant sold. The combined offering price to the public of each share of common stock and accompanying warrant is $1.30. The combined offering…

    MENLO PARK, Calif., May 22, 2020 (GLOBE NEWSWIRE) -- Geron Corporation (NASDAQ:GERN), a late-stage clinical biopharmaceutical company, today announced the pricing of its previously announced underwritten public offering of 107,049,375 shares of its common stock and pre-funded warrants to purchase 8,335,239 shares of common stock, together with accompanying warrants to purchase 57,692,307 shares of common stock. The common stock and pre-funded warrants will be sold in combination with an accompanying warrant to purchase 0.5 of a share of common stock issued for each share of common stock or pre-funded warrant sold. The combined offering price to the public of each share of common stock and accompanying warrant is $1.30. The combined offering price to the public of each pre-funded warrant and accompanying warrant is $1.299.

    All of the securities in the offering are being sold by Geron. The gross proceeds to Geron from this underwritten public offering are expected to be approximately $150 million, before deducting the underwriting discount and other estimated offering expenses payable by Geron. The offering is expected to close on or about May 27, 2020, subject to the satisfaction of customary closing conditions.

    Geron intends to use the net proceeds from this public offering to fund its ongoing IMerge Phase 3 clinical trial in lower risk myelodysplastic syndromes to top-line results, its planned Phase 3 clinical trial in refractory myelofibrosis to complete patient enrollment, and for working capital and general corporate purposes.

    Stifel and MTS Health Partners are acting as joint book-running managers for the offering. Needham & Company, BTIG and H.C. Wainwright & Co are acting as co-managers for the offering.

    This press release does not constitute an offer to sell or the solicitation of an offer to buy any of these securities, nor will there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

    A shelf registration statement on Form S-3 relating to the public offering of the shares of common stock and accompanying warrants described above was filed with the Securities and Exchange Commission (SEC) and is effective. A preliminary prospectus supplement relating to and describing the terms of the offering has been filed with the SEC and a final prospectus supplement relating to the offering will be filed with the SEC and will be available on the SEC's web site at www.sec.gov. When available, copies of the final prospectus supplement may also be obtained from the offices of Stifel, Nicolaus & Company, Incorporated, Attention: Syndicate, One Montgomery Street, Suite 3700, San Francisco, California 94104, by telephone at 415-364-2720 or by email at syndprospectus@stifel.com; or MTS Securities, LLC, 623 Fifth Avenue, 14th Floor, New York, New York 10022, by telephone at 646-975-6548 or by email at tamirisa@mtspartners.com.

    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.

    Use of Forward-Looking Statements

    Investors are cautioned that statements in this press release regarding the anticipated gross proceeds from the offering and completion and timing of the public offering constitute forward-looking statements that involve risks and uncertainties, including, without limitation, risks and uncertainties related to: market and other conditions; the satisfaction of customary closing conditions related to the public offering and the impact of general economic, industry or political conditions in the United States or internationally, including the impact of the COVID-19 pandemic on our business operations and activities. There can be no assurance that Geron will be able to complete the public offering on the anticipated terms, or at all. Geron will continue to need significant additional capital to fund its operations and may be unable to raise capital when needed, which would force Geron to delay, reduce or eliminate its imetelstat clinical development program. Actual results may differ materially from the results anticipated in these forward-looking statements. Additional information on other potential factors that could affect Geron's results and other risks and uncertainties can be found under the heading "Risk Factors" in Geron's periodic reports, including its Annual Report on Form 10-K for the year ended December 31, 2019, and in the preliminary prospectus supplement related to the public offering filed with the SEC on May 21, 2020 available on the SEC's web site at www.sec.gov. Geron expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in its expectations with regard thereto or any change in events, conditions or circumstances on which any such statements are based.

    CONTACT:

    Suzanne Messere
    Investor and Media Relations
    investor@geron.com
    media@geron.com

    CG Capital
    877-889-1972

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  39. MENLO PARK, Calif., May 21, 2020 (GLOBE NEWSWIRE) -- Geron Corporation (NASDAQ:GERN), a late-stage clinical biopharmaceutical company, today announced that it intends to offer and sell shares of its common stock and accompanying warrants to purchase shares of its common stock in an underwritten public offering. All of the securities in the proposed offering are to be sold by Geron. The offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.

    Stifel and MTS Health Partners are acting as joint book-running managers for the proposed offering.

    A shelf registration statement on Form S-3 relating to the public offering…

    MENLO PARK, Calif., May 21, 2020 (GLOBE NEWSWIRE) -- Geron Corporation (NASDAQ:GERN), a late-stage clinical biopharmaceutical company, today announced that it intends to offer and sell shares of its common stock and accompanying warrants to purchase shares of its common stock in an underwritten public offering. All of the securities in the proposed offering are to be sold by Geron. The offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.

    Stifel and MTS Health Partners are acting as joint book-running managers for the proposed offering.

    A shelf registration statement on Form S-3 relating to the public offering of the shares of common stock and accompanying warrants described above was previously filed with the Securities and Exchange Commission (SEC) and subsequently declared effective by the SEC. A preliminary prospectus supplement relating to and describing the terms of the proposed offering will be filed with the SEC and will be available on the SEC's web site at www.sec.gov. When available, copies of the preliminary prospectus supplement relating to the proposed offering may also be obtained from Stifel, Nicolaus & Company, Incorporated, Attention: Syndicate, One Montgomery Street, Suite 3700, San Francisco, California 94104, by telephone at 415-364-2720 or by email at syndprospectus@stifel.com; or MTS Securities, LLC, 623 Fifth Avenue, 14th Floor, New York, New York 10022, by telephone at 646-975-6548 or by email at tamirisa@mtspartners.com.

    This press release does not constitute an offer to sell or the solicitation of an offer to buy any of these securities, nor will there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

    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.

    Use of Forward-Looking Statements

    Investors are cautioned that statements in this press release regarding the intention, completion, timing and option relating to the proposed public offering constitute forward-looking statements that involve risks and uncertainties, including, without limitation, risks and uncertainties related to: whether or not Geron will be able to raise capital through the sale of its securities; the final terms of the proposed offering, market and other conditions; the satisfaction of customary closing conditions related to the proposed public offering and the impact of general economic, industry or political conditions in the United States or internationally, including the impact of the COVID-19 pandemic on our business operations and activities. There can be no assurance that Geron will be able to complete the proposed public offering on acceptable terms, or at all. Geron will continue to need significant additional capital to fund its operations and may be unable to raise capital when needed, which would force Geron to delay, reduce or eliminate its imetelstat development program. Actual results may differ materially from the results anticipated in these forward-looking statements. Additional information on other potential factors that could affect Geron's results and other risks and uncertainties can be found under the heading "Risk Factors" in Geron's periodic reports, including its Annual Report on Form 10-K for the year ended December 31, 2019 and in the preliminary prospectus supplement related to the proposed offering to be filed with the SEC on or about the date hereof, each available on the SEC's web site at www.sec.gov. Geron expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in its expectations with regard thereto or any change in events, conditions or circumstances on which any such statements are based.

    CONTACT:

    Suzanne Messere
    Investor and Media Relations
    investor@geron.com
    media@geron.com

    CG Capital
    877-889-1972

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    • Geron plans to move forward with a Phase 3 clinical trial in refractory myelofibrosis (MF) with overall survival (OS) as a primary endpoint, which is expected to open for screening and enrollment in first quarter 2021

    • Completion of patient enrollment for the ongoing IMerge Phase 3 clinical trial in lower risk myelodysplastic syndromes (MDS) is expected first quarter 2021

    • Revised operating expense guidance of $70 - $75 million for 2020

    • Conference call scheduled for Thursday, May 28 at 4:30 p.m. ET

    MENLO PARK, Calif., May 21, 2020 (GLOBE NEWSWIRE) -- Geron Corporation (NASDAQ:GERN), a late-stage clinical biopharmaceutical company, today announced plans for a Phase 3 clinical trial in MF patients who are refractory to treatment with a janus kinase…

    • Geron plans to move forward with a Phase 3 clinical trial in refractory myelofibrosis (MF) with overall survival (OS) as a primary endpoint, which is expected to open for screening and enrollment in first quarter 2021

    • Completion of patient enrollment for the ongoing IMerge Phase 3 clinical trial in lower risk myelodysplastic syndromes (MDS) is expected first quarter 2021

    • Revised operating expense guidance of $70 - $75 million for 2020

    • Conference call scheduled for Thursday, May 28 at 4:30 p.m. ET

    MENLO PARK, Calif., May 21, 2020 (GLOBE NEWSWIRE) -- Geron Corporation (NASDAQ:GERN), a late-stage clinical biopharmaceutical company, today announced plans for a Phase 3 clinical trial in MF patients who are refractory to treatment with a janus kinase (JAK) inhibitor, including trial design and expected timelines for trial start and future data readouts. Geron also provided an update on its ongoing IMerge Phase 3 clinical trial in lower risk MDS and reported revised fiscal year 2020 operating expense guidance.

    "We are very pleased to announce that following a productive meeting with the FDA, we plan to move forward with a randomized Phase 3 clinical trial in refractory MF," said John A. Scarlett, M.D., Chairman and Chief Executive Officer. "Our planned Phase 3 clinical trial in refractory MF will compare imetelstat to best available therapy that excludes JAK inhibitors and has overall survival as the primary endpoint. Also, we have an ongoing Phase 3 clinical trial in lower risk MDS with transfusion independence as the primary endpoint and durability of transfusion independence as a key secondary endpoint. We believe the results from these two Phase 3 clinical trials will differentiate imetelstat, due to its unique mechanism of action, from currently available therapies and enable Geron to become a leader in the treatment of hematologic myeloid malignancies."

    Planned Phase 3 Clinical Trial in Refractory Myelofibrosis (MF)

    The planned Phase 3 clinical trial in refractory MF is designed to be an open label 2:1 randomized, controlled trial to evaluate imetelstat (9.4 mg/kg administered by intravenous infusion every three weeks) in approximately 320 patients with Intermediate-2 or High-risk MF. Patients eligible for the trial will be required to be refractory to a JAK inhibitor, an inclusion criterion that is planned to be defined as having an inadequate spleen response or symptom response after treatment with a JAK inhibitor for at least six months, including an optimal dose of a JAK inhibitor for at least two months. The control arm is planned to be best available therapy (BAT), excluding JAK inhibitors. The primary efficacy endpoint for the trial is planned to be overall survival (OS). Planned 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.

    Currently, the planned Phase 3 clinical trial in refractory MF has been designed with more than 85% power to detect a 40% reduction in the risk of death for the imetelstat treated patients (hazard ratio=0.60; one-sided alpha=0.025), for example, 14 months for the BAT arm and 23 months for the imetelstat arm. The final analysis for OS is planned to be conducted after more than 50% of the total enrolled patients have died. An interim analysis of OS, in which the alpha spend is expected to be approximately 0.01, is planned to be conducted after approximately 70% of the total projected number of events, or deaths, for the final analysis have occurred. At the interim analysis, if the pre-specified statistical OS criterion is met, then Geron expects such data may support registration of imetelstat in refractory MF. If the prespecified OS criterion is not met at interim analysis, the trial will continue to the final analysis. Both the planned interim and final analyses are event driven and could occur on different timelines than currently expected.

    The trial design for the planned Phase 3 clinical trial in refractory MF was discussed with the U.S. Food and Drug Administration (FDA) at a Type C meeting in the second quarter of 2020. The FDA accepted the proposed trial design, including the definition of the refractory MF patient population, the primary efficacy endpoint of OS, secondary endpoints, the use of BAT for the control arm that excludes JAK inhibitors, and the statistical design and methods to be used to analyze data from the trial for the interim and final analyses. Although the FDA urged Geron to consider a third dosing arm to assess a lower dose and/or a more frequent dosing schedule that might identify a less toxic regimen and/or improve spleen response, one of the trial's secondary endpoints, the FDA did not object to Geron's proposed imetelstat dose and schedule of 9.4 mg/kg every three weeks. Geron believes the current design of the planned Phase 3 clinical trial will support, if the trial is successful, the registration of imetelstat in refractory MF.

    Currently, Geron expects to engage over 150 sites to participate in the global Phase 3 clinical trial in refractory MF across North America, South America, Europe and Asia. Geron plans to open the trial for screening and enrollment in the first quarter of 2021. Under current assumptions, Geron expects to complete patient enrollment in the planned Phase 3 clinical trial in refractory MF in the second half of 2022, to conduct an interim analysis in the first half of 2023 and to conduct a final analysis in the first half of 2024. The timing and achievement of enrollment completion and either or both of the planned analyses depend on numerous factors, including obtaining regulatory clearance of the trial protocol, Geron's ability to raise additional capital, and delays or interruptions related to the evolving effects of the COVID-19 pandemic.

    Update on IMerge Phase 3 Clinical Trial in Lower Risk Myelodysplastic Syndromes (MDS)

    As of the end of April 2020, approximately 68% of planned clinical sites for the IMerge Phase 3 clinical trial in lower risk MDS were open for enrollment. Due to the effects of the COVID-19 pandemic on site initiations and enrollment, Geron now plans to complete patient enrollment by the end of the first quarter of 2021. To facilitate this timing, the Company is currently evaluating the feasibility of increasing the number of participating countries by six, and the number of clinical sites by 40. Following 15 months from the last patient being enrolled, a primary analysis of efficacy and safety data from the trial will begin to enable top-line results. Under current assumptions, the Company expects top-line results to be available in the second half of 2022. This anticipated timing is subject to potential delays or interruptions associated with the evolving effects of the COVID-19 pandemic, regardless of Geron's evaluation of additional countries and sites.

    The IMerge Phase 3 clinical trial has been designed with more than 85% power to detect a statistically significant difference in the primary endpoint of 8-week transfusion independence between the imetelstat treatment arm and the placebo arm. Based on discussions with U.S. and European regulatory authorities, Geron believes the IMerge Phase 3 clinical trial, if successful, will support the registration of imetelstat in lower risk MDS.

    Revised Guidance and Development Priorities

    The Company expects its 2020 operating expense burn to range from $70 to $75 million. This guidance reflects cash conservation measures implemented in April due to the COVID-19 pandemic, such as suspending travel and postponing a planned imetelstat proof of concept study, as well as the new costs for startup activities associated with the planned Phase 3 clinical trial in refractory MF and the additional costs for the expansion of clinical sites for the IMerge Phase 3 clinical trial. Spending in 2020 is expected to support the following development priorities, subject to the evolving effects of the COVID-19 pandemic:

    Development priorities for 2020

    • Startup activities for the planned Phase 3 clinical trial in refractory MF to enable the trial to be open for screening and enrollment in the first quarter of 2021.
       
    • Continue working with investigators participating in the ongoing IMerge Phase 3 clinical trial in order to complete patient enrollment in the trial by the end of the first quarter of 2021.
       
    • Oral presentation of more mature IMerge Phase 2 data, including durability of transfusion independence in lower risk MDS, at the Virtual European Hematology Association (EHA) Annual Congress on June 12.

      An abstract published online on May 14, 2020 described long-term efficacy and safety data, including one-year transfusion free interval and the longest median duration of red blood cell transfusion independence reported to date in the trial. The abstract is available on the EHA website at www.ehaweb.org/congress.             
    • Poster presentations at the Virtual EHA Annual Congress of new analyses from IMbark Phase 2 data providing further evidence of observed improvement in OS as an indicator of potential disease-modifying activity of imetelstat in relapsed/refractory MF.

      Three abstracts published online on May 14, 2020 suggest that dose-related improvements in OS correlate with other clinical benefits, such as symptom and spleen response as well as fibrosis improvement observed in the trial; improvements in OS in a patient subpopulation with a poor prognosis due to the absence of the three primary driver mutations in MF, or triple-negative; and dose-dependent inhibition of telomerase with imetelstat, resulting in on-target activity that correlates with improvement in OS. Taken together, Geron believes the three MF abstracts substantiate the OS outcome observed in IMbark and support the planned Phase 3 clinical trial in refractory MF.

    The previously announced proof of concept study in High-risk MDS and acute myeloid leukemia (AML), originally expected to begin in the fourth quarter of 2020, has been postponed in order to prioritize the Phase 3 clinical trials in lower risk MDS and refractory MF.

    Upcoming Events

    • Q1 2020 Financial Results
    May 28, after market close
    • Virtual Annual Stockholder Meeting
    June 5, 8 a.m. PT
    • Virtual EHA Annual Congress
    June 11-14
    • Post-EHA KOL Virtual Event
    June 17, before market open

    Conference Call

    Geron will host a conference call at 4:30 p.m. ET on Thursday, May 28, 2020 to discuss plans for the Phase 3 clinical trial in refractory MF, as well as an update on the IMerge Phase 3 clinical trial and first quarter financial results.

    Participants may access the conference call live via telephone by dialing domestically +1 (833) 513-0551 or internationally +1 (647) 689-4209. The conference ID is 5582655. A live, listen-only webcast will also be available on the Company's website at www.geron.com/investors/events. If you are unable to listen to the live call, an archived webcast will be available on the Company's website for 30 days.

    Unmet Medical Need in Lower Risk Myelodysplastic Syndromes (MDS)

    MDS is a group of blood disorders in which the continuous upregulation of telomerase is associated with the proliferation of malignant progenitor cells which 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. In MDS, bone marrow and peripheral blood cells may have abnormal, or dysplastic, cell morphology. MDS is frequently characterized clinically by severe anemia, or low red blood cell counts, and low hemoglobin. In addition, other peripheral cytopenias, or low numbers of white blood cells and platelets, may cause life-threatening infections and bleeding. Transformation to AML occurs in up to 30% of MDS cases and results in poorer overall survival.

    MDS is the most common of the myeloid malignancies and is primarily a disease of the elderly, with median age at diagnosis around 70 years. In addition, MDS patients are grouped using the World Health Organization (WHO) classification system, which was most recently updated in 2016. It divides MDS into types based mainly on how the cells in the bone marrow look under the microscope, as well as other factors. Common MDS subgroups include ringed sideroblast positive, or RS+, and ringed sideroblast negative, or RS-.

    The majority of MDS patients, approximately 70%, fall into what are considered to be the lower risk groups at diagnosis, according to the International Prognostic Scoring System that takes into account the presence of a number of disease factors, such as cytopenias and cytogenetics, to assign relative risk of progression to AML and overall survival. There are more than 100,000 people worldwide and 40,000 people in the U.S. living with lower risk MDS. In addition, more than 10,000 new cases of lower risk MDS are reported each year in the U.S. Based on Geron's internal estimates of pricing and addressable patient population, if imetelstat is approved for commercial use by the FDA and foreign regulatory authorities in lower risk MDS, Geron believes the annual revenue potential in lower risk MDS in the U.S. could exceed $500 million and $1 billion worldwide.

    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 a poorer overall survival and a higher risk of developing AML.

    Geron believes that imetelstat, a first-in-class telomerase inhibitor, has the potential to inhibit the uncontrolled proliferation of malignant stem and progenitor cells in MDS, resulting in reduction of dysfunctional blood cell production and potentially enabling recovery of normal hematopoiesis.

    Unmet Medical Need in Intermediate-2 or High-risk Myelofibrosis (MF)

    MF, 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. As a result, normal blood production in the bone marrow is impaired and may shift to other organs, such as the spleen and liver, which can cause them to enlarge. 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 described in a 2011 Journal of Clinical Oncology article. 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. In addition, more than 2,000 new cases are reported each year in the U.S. Based on Geron's internal estimates of pricing and addressable patient population, if imetelstat is approved for commercial use by the FDA and foreign regulatory authorities in refractory MF, Geron believes the annual revenue potential in refractory MF in the U.S. could exceed $750 million and $1.5 billion worldwide.

    The only drug therapies approved by the FDA for treating MF patients with Intermediate-2 or High-risk disease are the JAK inhibitors, ruxolitinib and fedratinib. According to medical literature, approximately 50% of patients discontinue treatment with ruxolitinib within three years and 75% within five years due to disease progression, adverse events, and unsatisfactory response to treatment. Currently, no drug therapy is specifically approved by the FDA for those patients who fail or no longer respond to JAK inhibitor treatment, and median survival for such refractory MF patients after discontinuation from ruxolitinib is only approximately 14 to 16 months, representing a significant unmet medical need.

    As a telomerase inhibitor, Geron believes that imetelstat has the potential to inhibit the uncontrolled proliferation of malignant stem and progenitor cells in refractory MF patients to reduce dysfunctional blood cell production and potentially enable recovery of normal hematopoiesis.

    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.

    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) the therapeutic potential of imetelstat, including imetelstat's potential survival benefit for refractory MF patients; (ii) that for the planned Phase 3 clinical trial in refractory MF, Geron expects to begin patient enrollment in the first quarter of 2021, complete patient enrollment in the second half of 2022, conduct an interim analysis in the first half of 2023 and conduct a final analysis in the first half of 2024; (iii) the design, commencement and conduct of the planned Phase 3 clinical trial in refractory MF; (iv) that imetelstat may have disease-modifying activity; (v) that for IMerge, Geron expects to complete enrollment in the first quarter of 2021 and have top-line results in the second half of 2022; (vi) IMerge's design, including that IMerge will potentially demonstrate durable transfusion independence; (vii) that the combined potential revenue for imetelstat in lower risk MDS and refractory MF could exceed $1.25 billion in the U.S. and $2.5 billion worldwide; (viii) Geron's development priorities for 2020; (ix) that Geron's 2020 operating expense range will be $70-75 million; 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 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 evolving effects of the COVID-19 pandemic, and overcomes the clinical, safety, efficacy, technical, scientific, intellectual property, manufacturing and regulatory challenges in order to meet the expected timelines and planned milestones in (ii), (v) and (viii) 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 clinical trials; (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 may not successfully market imetelstat or that competition could cause imetelstat not to achieve the revenue potential in (vii) above; (h) whether imetelstat is able to maintain patent protection, obtain and maintain the orphan drug exclusivity and have freedom to operate; (i) Geron's 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 (ii), (v) and (viii) above; (j) whether there are cost overruns in 2020 due to the evolving effects of the COVID-19 pandemic or otherwise; (k) whether Geron can accurately project or attain complete enrollment in IMerge, the planned Phase 3 refractory MF trial or of any potential future clinical trials of imetelstat, whether due to the evolving effects of the COVID-19 pandemic or otherwise; and (l) whether there are failures or delays in manufacturing sufficient quantities of imetelstat or other clinical trial materials in a timely manner, whether due to the evolving effects of the COVID-19 pandemic or otherwise. 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 Annual Report on Form 10-K for the year ended December 31, 2019, Geron's Current Report on Form 8-K filed on May 8, 2020, and future filings and reports by Geron, including Geron's preliminary prospectus supplement to be filed with the SEC on or about the date hereof. 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.

    CONTACT:

    Suzanne Messere
    Investor and Media Relations
    investor@geron.com 
    media@geron.com 

    CG Capital
    877-889-1972

    Primary Logo

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  40. Geron Corporation (NASDAQ:GERN) today reported that it has granted a non-statutory stock option to purchase an aggregate of 70,000 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 May 20, 2020 at an exercise price of $1.89 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 Corporation (NASDAQ:GERN) today reported that it has granted a non-statutory stock option to purchase an aggregate of 70,000 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 May 20, 2020 at an exercise price of $1.89 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 a material inducement to employment in accordance with Nasdaq Listing Rule 5635(c)(4) and is subject to the terms and conditions of a 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 myeloid malignancies. For more information about Geron, visit www.geron.com.

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  41. Geron Corporation (NASDAQ:GERN), a late-stage clinical biopharmaceutical company, today announced that four abstracts containing new clinical data and analyses related to imetelstat, the Company's first-in-class telomerase inhibitor, have been accepted for presentation at the Virtual Edition of the European Hematology Association (EHA) Annual Congress to be held online from June 11-14, 2020. The abstracts are available on the EHA website at www.ehaweb.org/congress.

    "We are pleased to report very encouraging durability data from the IMerge Phase 2 clinical trial to be presented at the upcoming EHA Annual Congress, including a median duration of 8-week transfusion independence of 88 weeks, which is the longest duration we have reported to date…

    Geron Corporation (NASDAQ:GERN), a late-stage clinical biopharmaceutical company, today announced that four abstracts containing new clinical data and analyses related to imetelstat, the Company's first-in-class telomerase inhibitor, have been accepted for presentation at the Virtual Edition of the European Hematology Association (EHA) Annual Congress to be held online from June 11-14, 2020. The abstracts are available on the EHA website at www.ehaweb.org/congress.

    "We are pleased to report very encouraging durability data from the IMerge Phase 2 clinical trial to be presented at the upcoming EHA Annual Congress, including a median duration of 8-week transfusion independence of 88 weeks, which is the longest duration we have reported to date in this trial, and that 29% of patients were transfusion free for more than one year," said John A. Scarlett, M.D., Geron's Chairman and Chief Executive Officer. "We are also pleased that the potential survival benefit associated with imetelstat treatment in the IMbark Phase 2 clinical trial for patients relapsed or refractory to JAK inhibitors was correlated with other clinical benefits observed in the trial, such as symptom response, spleen volume reduction and improvement in fibrosis."

    Updated Efficacy and Safety Data from the IMerge Phase 2 Clinical Trial

    IMerge is a two-part Phase 2/3 clinical trial evaluating imetelstat in transfusion dependent patients with Low or Intermediate-1 risk myelodysplastic syndromes (lower risk MDS), who are relapsed after or refractory to prior treatment with erythropoiesis stimulating agents (ESAs). The primary efficacy endpoint of IMerge is 8-week red blood cell transfusion independence (RBC-TI) rate, defined as the proportion of patients not receiving any RBC transfusion during any consecutive eight weeks since entry into the trial. Key secondary endpoints include 24-week RBC-TI rate and the rate of hematologic improvement-erythroid (HI-E), defined as a rise in hemoglobin of at least 1.5 g/dL above the pretreatment level for at least eight weeks or a reduction of at least four units of RBC transfusions over eight weeks compared with the prior RBC transfusion burden.

    Abstract Title: Treatment with Imetelstat Provides Durable Transfusion Independence (TI) in Heavily Transfused Non-del(5q) Lower Risk MDS (LR-MDS) Relapsed/Refractory (R/R) to Erythropoiesis Stimulating Agents (ESAs)

    The abstract, accepted for an oral presentation, reports long-term efficacy and safety data from 38 patients in the IMerge Phase 2 clinical trial, based on a February 4, 2020 cut-off date and a median follow-up of 24 months.

    Key data highlights from the abstract:

    • 75% of the 16 (42%) 8-week RBC-TI responders showed a hemoglobin rise of > 3 g/dL during the transfusion-free interval when compared to pretreatment level.
    • 12 patients (32%) achieved a 24-week RBC-TI.
    • 11 patients (29%) were transfusion free for more than one year, and the longest transfusion free interval was 2.7 years.
    • Median RBC-TI duration was 88 weeks, the longest reported to date in the trial.
    • HI-E was achieved by 26 patients (68%) with a median duration of 93 weeks.
    • Cytogenetic and mutational malignant clone reduction in some patients indicates potential disease-modifying activity of imetelstat.
    • Most frequently reported adverse events were manageable and reversible grade > 3 cytopenias.

    Oral Presentation Details:

    Session Title: Novel Treatments for MDS I

    Abstract Code: S183

    Please check www.ehaweb.org/congress for updates regarding the virtual presentation schedule.

    New Analyses of Data from IMbark Phase 2 Clinical Trial

    IMbark was designed as a Phase 2 clinical trial to evaluate two dosing regimens of imetelstat (either 4.7 mg/kg or 9.4 mg/kg administered by intravenous infusion every three weeks) in patients with Intermediate-2 or High-risk myelofibrosis (MF) who have relapsed after or are refractory to prior treatment with a janus kinase inhibitor (JAKi). The co-primary efficacy endpoints for IMbark were spleen response rate, defined as the proportion of patients who achieve a reduction of at least 35% in spleen volume as assessed by imaging, and symptom response rate, defined as the proportion of patients who achieve a reduction of at least 50% in Total Symptom Score (TSS), at 24 weeks. Key secondary endpoints were overall survival (OS) and safety.

    Abstract Title: Favorable Overall Survival with Imetelstat Treatment Correlates with Other Clinical Benefits in Intermediate-2 or High-Risk Myelofibrosis Relapsed/Refractory to Janus Kinase Inhibitor

    The abstract, accepted for a poster presentation, reports new analyses of data from all 107 patients in both arms (59 patients in the 9.4 mg/kg arm and 48 patients in the 4.7 mg/kg arm) of the IMbark Phase 2 clinical trial with a data cut-off date of February 19, 2020 and a median follow-up of 41.7 months. As of the data cut-off date, median OS was 28.1 months in the 9.4 mg/kg arm and 19.9 months in the 4.7 mg/kg arm. The new analyses report a trend of longer OS in patients who achieved symptom response, spleen volume reductions ranging from > 10% to > 35%, and improvement in bone marrow fibrosis. The abstract concludes that these data show dose-related improvements in OS with imetelstat in patients who are relapsed/refractory to JAKi and that the potential survival benefit observed in IMbark with imetelstat was supported by the trend of correlation with other clinical benefits, such as symptom response and spleen volume reduction, as well as fibrosis improvement.

    Poster Presentation Details:

    Session Title: Myeloproliferative neoplasms—Clinical

    Abstract Code: EP1107

    Please check www.ehaweb.org/congress for updates regarding when EHA e-Poster presentations are scheduled to be available.

    Abstract Title: Imetelstat Treatment Results in Clinical Benefits, Including Improved Overall Survival, in Patients with Higher-Risk Triple Negative Myelofibrosis Relapsed/Refractory to Janus Kinase Inhibitors (JAKI)

    The abstract, accepted for a poster presentation, presents new analyses of clinical outcomes, including OS, in triple-negative (TN) patients enrolled in the IMbark Phase 2 clinical trial. Triple-negative MF patients lack the three driver mutations of the disease, JAK2, CALR or MPL, which represents a high-risk molecular signature. These patients have a higher incidence of leukemic transformation and approximately 3-year overall survival from diagnosis when compared to non-TN patients. The abstract concludes that TN patients treated with 9.4 mg/kg in the IMbark Phase 2 clinical trial had better clinical outcomes, such as spleen and symptom response as well as better improvement in fibrosis and OS, when compared to non-TN patients. These data suggest that imetelstat may overcome the poor outcomes expected with TN patients.

    Poster Presentation Details:

    Session Title: Myeloproliferative neoplasms—Clinical

    Abstract Code: EP1101

    Please check www.ehaweb.org/congress for updates regarding when EHA e-Poster presentations are scheduled to be available.

    Abstract Title: Telomerase Activity, Telomere Length and hTERT Expression Correlate with Clinical Outcomes in Higher-Risk Myelofibrosis (MF) Relapsed/Refractory (R/R) to Janus Kinase Inhibitor Treated with Imetelstat

    The abstract, accepted for a poster presentation, reports biomarker results and their correlation with the clinical benefits of treatment with imetelstat in patients from the IMbark Phase 2 clinical trial. These results showed dose-dependent inhibition of the telomerase target, as evaluated by reductions in telomerase activity, human reverse transcriptase (hTERT) levels and telomere length, in the IMbark patients treated with imetelstat, and this on-target activity correlated with clinical responses and longer OS. In addition, dose-dependent reduction in variant allele frequency of driver mutations was noted, indicating imetelstat targets the underlying malignant clone. The abstract concludes that these data are consistent with telomere biology in cancer cells and provide evidence for the on-target mechanism of action of imetelstat through telomerase inhibition.

    Poster Presentation Details:

    Session Title: Myeloproliferative neoplasms—Clinical

    Abstract Code: EP1098

    Please check www.ehaweb.org/congress for updates regarding when EHA e-Poster presentations are scheduled to be available.

    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 Annual Congress may not be made public before the presentation. The slide presentation and posters will be available at www.geron.com/r-d/publications following the EHA Annual Congress presentations.

    Post-EHA Event with Key Opinion Leaders

    In June, Geron plans to host a webcasted event after the EHA Annual Congress. At the event, authors from each of the imetelstat abstracts will reprise the respective presentations from the EHA Annual Congress. A press release with event details, including how to access a webcast link, will be available on Geron's website at the beginning of June 2020.

    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. Clinical studies of imetelstat sponsored by Geron include IMerge, a Phase 2/3 trial in lower risk myelodysplastic syndromes (MDS), and IMbark, a Phase 2 trial in Intermediate-2 or High-risk myelofibrosis (MF). 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 clinical stage 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.

    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 survival benefit for MF patients who have relapsed after, or are refractory to, prior treatment with a JAKi (relapsed/refractory MF); (ii) the suggestion that imetelstat may overcome poor outcomes in "triple-negative" relapsed/refractory MF patients; (iii) that imetelstat may have 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 whether: (i) the 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; (ii) imetelstat in clinical trials is able to demonstrate (a) an overall survival benefit in relapsed/refractory MF patients, and (b) overcome the poor outcomes in "triple-negative" relapsed/refractory MF patients; (iii) imetelstat demonstrates disease-modifying activity in clinical trials; (iv) regulatory authorities permit the further development of imetelstat on a timely basis, or at all, without any clinical holds; (v) imetelstat is safe and efficacious; (vi) Geron can accurately project or attain complete enrollment in IMerge or of any potential future clinical trials of imetelstat, whether due to the evolving effects of the COVID-19 pandemic or otherwise; (vii) there occur failures or delays in manufacturing sufficient quantities of imetelstat or other clinical trial materials in a timely manner, whether due to the evolving effects of the COVID-19 pandemic or otherwise; and (viii) any future efficacy or safety results cause the benefit-risk profile of imetelstat to become unacceptable. 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 annual report on Form 10-K for the year ended December 31, 2019 and the information included in the Form 8-K filed on May 8, 2020. 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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  42. Geron Corporation (NASDAQ:GERN) today reported that it has granted non-statutory stock options to purchase an aggregate of 500,000 shares of Geron common stock as inducements to two newly-hired employees in connection with commencement of employment with the Company.

    The stock options were granted on April 15, 2020 at an exercise price of $1.19 per share, which is equal to the closing price of Geron common stock on the date of grant. Each stock option granted has a 10-year term. Options to purchase 400,000 shares 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…

    Geron Corporation (NASDAQ:GERN) today reported that it has granted non-statutory stock options to purchase an aggregate of 500,000 shares of Geron common stock as inducements to two newly-hired employees in connection with commencement of employment with the Company.

    The stock options were granted on April 15, 2020 at an exercise price of $1.19 per share, which is equal to the closing price of Geron common stock on the date of grant. Each stock option granted has a 10-year term. Options to purchase 400,000 shares 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. Options to purchase 100,000 shares vest in full upon the one year anniversary of the hire date, subject to continued employment with Geron on the vesting date. All of 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 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. For more information about Geron, visit www.geron.com.

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  43. MENLO PARK, Calif., April 08, 2020 (GLOBE NEWSWIRE) -- Geron Corporation (NASDAQ:GERN) today announced that John A. Scarlett, M.D., Chairman and Chief Executive Officer, is scheduled to present a company overview at the 19th Annual Needham Virtual Healthcare Conference at 10:00 a.m. ET on Wednesday, April 15, 2020.

    A live audio webcast of the presentation will be available on Geron's website, www.geron.com/investors/events. If you are unable to listen to the live presentation, an archived webcast will be available on the Company's website for 30 days.

    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…

    MENLO PARK, Calif., April 08, 2020 (GLOBE NEWSWIRE) -- Geron Corporation (NASDAQ:GERN) today announced that John A. Scarlett, M.D., Chairman and Chief Executive Officer, is scheduled to present a company overview at the 19th Annual Needham Virtual Healthcare Conference at 10:00 a.m. ET on Wednesday, April 15, 2020.

    A live audio webcast of the presentation will be available on Geron's website, www.geron.com/investors/events. If you are unable to listen to the live presentation, an archived webcast will be available on the Company's website for 30 days.

    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.

    CONTACT:

    Suzanne Messere
    Investor and Media Relations
    investor@geron.com 
    media@geron.com 

    CG Capital
    877-889-1972

    Primary Logo

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  44. MENLO PARK, Calif., April 02, 2020 (GLOBE NEWSWIRE) -- Geron Corporation (NASDAQ:GERN), a late-stage clinical development biopharmaceutical company, today announced an update to information from its March 12 year-end conference call related to the impact of the COVID-19 pandemic on the Company's business, and described the measures being taken to protect the safety of Geron's employees and patients in its clinical trials.

    "We remain committed to advancing our imetelstat development plans, but recognize the unprecedented challenges created by the COVID-19 pandemic," said John A. Scarlett, M.D., Chairman and Chief Executive Officer. "Like many other drug development companies, our clinical trial activities are being impacted in countries where…

    MENLO PARK, Calif., April 02, 2020 (GLOBE NEWSWIRE) -- Geron Corporation (NASDAQ:GERN), a late-stage clinical development biopharmaceutical company, today announced an update to information from its March 12 year-end conference call related to the impact of the COVID-19 pandemic on the Company's business, and described the measures being taken to protect the safety of Geron's employees and patients in its clinical trials.

    "We remain committed to advancing our imetelstat development plans, but recognize the unprecedented challenges created by the COVID-19 pandemic," said John A. Scarlett, M.D., Chairman and Chief Executive Officer. "Like many other drug development companies, our clinical trial activities are being impacted in countries where healthcare systems are severely affected by the COVID-19 pandemic. Due to these circumstances, we no longer expect to complete enrollment in the IMerge Phase 3 trial or to commence our proof of concept study in high risk MDS and AML by the end of 2020, as we had originally planned. Given the fluid and rapidly evolving consequences of COVID-19, we cannot predict the long-term effect on IMerge timelines until we have more visibility on the length of the crisis and its impact on our IMerge clinical trial activities. We continue to monitor this situation and will provide an update on our next quarterly conference call."

    Geron's Chief Financial Officer, Olivia Bloom added, "To actively conserve our financial resources during these uncertain times, we have implemented measures to manage our near-term cash burn, and expect our spending in 2020 will be lower than the $70 to $75 million we previously guided. We plan to update our 2020 spending guidance, to the extent practicable, on our next quarterly conference call."

    Geron Business Updates

    Ongoing Operations

    The Company has taken steps to ensure the safety and well-being of its employees. In compliance with local ‘stay at home' measures and to limit the risk of exposure to and transmission of COVID-19, Geron has suspended all business travel and implemented a work from home policy for all employees. To enable business to continue virtually, Geron has made technology resources available to all employees.

    IMerge Phase 3 Clinical Trial

    Geron is planning to open more than 90 sites globally for the IMerge Phase 3 clinical trial. As of the end of March, 66% of the total sites were open in the United States, Europe, Middle East and Asia. Geron has provided guidance to IMerge investigators regarding COVID-19 intended to ensure the safety of patients while preserving the integrity of the trial.

    COVID-19 related challenges have led to delays in new site initiations and enrollment. As a result, the Company no longer expects to complete enrollment in IMerge by year-end 2020, as previously disclosed. Geron continues to monitor this situation and expects to provide an update on its next quarterly conference call.

    As previously disclosed, the Company has sufficient drug supply for the ongoing IMerge clinical trial.

    Potential Registration Strategy for Imetelstat in Myelofibrosis (MF)

    Geron currently has a scheduled meeting with the U.S. Food and Drug Administration (FDA) in the second quarter to discuss a potential regulatory approval path for imetelstat in MF. Geron expects to announce its decision regarding any potential late-stage development plans for MF by mid-year 2020.

    Managing 2020 Operating Expenses

    In response to the COVID-19 pandemic, Geron has implemented measures to manage its cash burn, including suspending travel and in-person meeting attendance, as well as re-evaluating its near-term hiring plan.

    With these measures, as well as the anticipated delays in both completing IMerge enrollment and commencement of the proof of concept study in high risk MDS and acute myeloid leukemia (AML), the Company expects its 2020 operating expense burn to be lower than the previously disclosed guidance of $70 to $75 million. Geron plans to update 2020 operating expense burn guidance on its next quarterly conference call.

    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. Clinical studies of imetelstat sponsored by Geron include IMerge, a Phase 2/3 trial in lower risk myelodysplastic syndromes (MDS), and IMbark, a Phase 2 trial in Intermediate-2 or High-risk myelofibrosis (MF). 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. For more information about Geron, visit www.geron.com.

    Use of Forward-Looking Statements

    Except for statements of historical fact, the statements contained in this press release are forward-looking statements made pursuant to the Safe Harbor provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements include statements regarding the expectations, plans, timelines, beliefs, potential and prospects for imetelstat and Geron, including, without limitation, statements related to: (i) that imetelstat may have disease-modifying activity; (ii) that Geron plans to discuss a potential regulatory approval path with the FDA in the second quarter and to make a decision by mid-year 2020 regarding any potential late-stage development of imetelstat in MF; (iii) that Geron's 2020 operating expense burn will be lower than the $70-$75 million that was previously guided; (iv) that Geron expects to update the timing for completion of enrollment in IMerge, commencement of the high risk MDS and AML proof of concept study, and its financial guidance at its next quarterly conference call; and (v) other statements that are not historical facts. 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, the following: (a) regulatory authorities may not permit the further development of imetelstat for MF and/or MDS and/or potential additional indications on a timely basis, or at all, and may impose clinical holds; (b) after interactions with the FDA, Geron may decide not to pursue further development of imetelstat in MF; (c) imetelstat may not demonstrate successful efficacy and safety in clinical trials; (d) Geron may be unable to project or attain complete enrollment of IMerge due to circumstances caused by the COVID-19 pandemic, such as: lack of patients, regulatory holds, insufficient number of sites, and/or unavailability of drug; (e) there may be failures or delays in manufacturing sufficient quantities of imetelstat, or other clinical trial materials, in a manner that meets the quality standards of the FDA and other regulatory authorities; (f) Geron may not be able to obtain sufficient funding to support further development of imetelstat; (g) imetelstat may fail to demonstrate in clinical trials that it has disease-modifying activity; and (h) Geron may decide not to start a proof-of-concept study in high risk MDS and AML. Additional information 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 in Geron's annual report on Form 10-K for the year ended December 31, 2019 and in subsequent filings on Form 8-K. 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.

    CONTACT:

    Suzanne Messere
    Investor and Media Relations
    investor@geron.com
    media@geron.com

    CG Capital
    877-889-1972

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  45. MENLO PARK, Calif., March 12, 2020 (GLOBE NEWSWIRE) -- 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 fourth quarter and year ended December 31, 2019 as well as 2020 milestones. The Company ended fiscal year 2019 with $159.2 million in cash and marketable securities.

    "2019 was a pivotal year for Geron as we completed the imetelstat program transition, assembled an impressive in-house team with a proven track record in drug development, and advanced imetelstat into late-stage development with the opening of our IMerge Phase 3 clinical trial in lower risk myelodysplastic…

    MENLO PARK, Calif., March 12, 2020 (GLOBE NEWSWIRE) -- 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 fourth quarter and year ended December 31, 2019 as well as 2020 milestones. The Company ended fiscal year 2019 with $159.2 million in cash and marketable securities.

    "2019 was a pivotal year for Geron as we completed the imetelstat program transition, assembled an impressive in-house team with a proven track record in drug development, and advanced imetelstat into late-stage development with the opening of our IMerge Phase 3 clinical trial in lower risk myelodysplastic syndromes," said John A. Scarlett, M.D., Chairman and Chief Executive Officer. "In 2020, we plan to complete enrollment in IMerge, announce our decision regarding any potential late-stage development plans for myelofibrosis by mid-year, and commence a proof of concept study in additional hematologic myeloid malignancies. With a strong team in place to execute these plans, we look forward to further advancing the development of imetelstat."  

    Planned 2020 Milestones

    Geron is planning for the following milestones in 2020:

    • Complete enrollment for the Phase 3 IMerge clinical trial in lower risk myelodysplastic syndromes (MDS) by the end of 2020

      Recently reported Phase 2 data continued to indicate meaningful and durable transfusion independence potentially achievable with imetelstat treatment in high transfusion burdened patients (> 4 units per 8 weeks). The Phase 3 IMerge clinical trial was opened for enrollment in August 2019, and the first patient was dosed in October 2019. As of the end of February 2020, 63% of planned clinical sites were opened for enrollment. Topline results are expected by mid-year 2022.

    • Determine a potential registration strategy for imetelstat in myelofibrosis (MF)

      As a follow up to an End of Phase 2 meeting with the U.S. Food and Drug Administration (FDA) in the fourth quarter of 2019, Geron plans to submit Phase 3 trial design proposals to the FDA and, in the second quarter, discuss with the FDA a potential regulatory approval path for imetelstat in MF. Geron expects to announce its decision regarding any potential late-stage development plans for MF by mid-year 2020.

    • Expect to present updated data and new analyses from the Phase 2 IMerge and IMbark clinical trials at future medical conferences

      Geron expects to present more mature data from the Phase 2 IMerge clinical trial in lower risk MDS for the continued treatment and follow-up of remaining patients, including durability of transfusion independence.

      Geron also expects to present new analyses from the IMbark Phase 2 clinical trial that correlate the median overall survival observed with other clinical endpoints from the trial. In addition, the new analyses are expected to provide further support for the potential improvement in overall survival as an indication of disease-modifying activity of imetelstat treatment in myelofibrosis.

    • Commence a proof of concept study of imetelstat in additional hematologic myeloid malignancies

      Geron plans to expand imetelstat's clinical development program with a proof of concept study in Intermediate-2 or High-risk, or higher risk, MDS and acute myeloid leukemia (AML) and expects to commence such a study by the end of the fourth quarter 2020.

    2019 Accomplishments

    • Clinical – Advanced MDS development and presented data supporting potential late-stage development in MDS and MF
       
      • Presented updated data from the Phase 2 IMerge clinical trial at the European Hematology Association (EHA) meeting in June 2019 that reported continued meaningful and durable transfusion independence.
      • Commenced screening and enrollment for the Phase 3 IMerge clinical trial in August 2019 and dosed the first patient in October 2019.
      • Presented Phase 2 IMbark data at EHA corroborating potential survival benefit of imetelstat in relapsed/refractory MF patients when compared to closely matched patients from real-world data treated with best available therapy.
         
    • Regulatory – Initiated FDA interactions to determine potential for late-stage development in MF
       
      • The FDA granted Fast Track designation to imetelstat for the treatment of adult patients with Intermediate-2 or High-risk relapsed/refractory MF in September 2019.
      • Conducted an End of Phase 2 meeting with the FDA in the fourth quarter of 2019.
         
    • Operational – Completed transition of imetelstat development program and enhanced development capabilities
       
      • Transitioned the imetelstat program back to Geron in the third quarter of 2019, including transfer of imetelstat investigational new drug (IND) sponsorship in May 2019.
      • Throughout 2019, recruited hematology-oncology research and development expertise, including many team members with prior experience with imetelstat, as well as both early- and late-stage development experience, to establish a multi-functional development team to support current and future development plans.
      • Re-established manufacturing supply chain to manufacture imetelstat.

    Fourth Quarter and Full Year 2019 Results

    For the fourth quarter of 2019, the Company reported a net loss of $29.1 million, or $0.15 per share, compared to $7.3 million, or $0.04 per share, for the fourth quarter of 2018. Net loss for the full year of 2019 was $68.5 million, or $0.36 per share, compared to $27.0 million, or $0.15 per share, for the full year of 2018.

    Revenues for the three and twelve months ended December 31, 2019 were $171,000 and $460,000, respectively, compared to $375,000 and $1.1 million for the same periods in 2018. Revenues for the three and twelve months ended December 31, 2019 and 2018 included royalty and license fee revenues under various non-imetelstat license agreements. The decline in revenues reflects a reduction in the number of active research license agreements in 2019 related to the Company's human telomerase reverse transcriptase, or hTERT, technology as a result of patent expirations on the underlying technology.

    Total operating expenses for the three and twelve months ended December 31, 2019 were $30.2 million and $73.0 million, respectively, compared to $10.0 million and $32.1 million for the same periods in 2018. Research and development expenses for the three and twelve months ended December 31, 2019 were $24.9 million and $52.1 million, respectively, compared to $5.1 million and $13.4 million for the same periods in 2018. The increase in research and development expenses, compared to the same periods in 2018, primarily reflects costs for the transition of the imetelstat program, including resuming sponsorship of the ongoing imetelstat clinical trials; expenses for start-up activities for the IMerge Phase 3 clinical trial; purchase of inventories of drug product, drug substance and raw materials from Janssen; and higher personnel-related costs for the expanding development team. General and administrative expenses for the three and twelve months ended December 31, 2019 were $5.3 million and $20.9 million, respectively, compared to $4.9 million and $18.7 million for the same periods in 2018. The increase in general and administrative expenses, compared to the same periods in 2018, primarily reflects higher corporate and patent legal costs and increased personnel-related expenses for additional general and administrative headcount to support the development organization.

    Interest and other income for the three and twelve months ended December 31, 2019 was $925,000 and $4.2 million, respectively, compared to $1.1 million and $3.3 million for the same periods in 2018. The overall increase in interest and other income in 2019 when compared to 2018 primarily reflects higher yields on the Company's marketable securities portfolio.

    The Company ended the 2019 fiscal year with $159.2 million in cash and marketable securities. The Company expects these funds to be sufficient to continue the IMerge clinical trial in 2020 and to commence a proof of concept study in 2020.

    Projected 2020 Financial Guidance

    For fiscal year 2020, the Company expects its operating expense burn to range from $70 to $75 million, which includes costs related to the global Phase 3 IMerge clinical trial in MDS; validation of supply chain vendors for the manufacturing of imetelstat; further interactions with the FDA in connection with the planned submission of Phase 3 trial design proposals in MF and discussion regarding a potential regulatory approval path in MF; and commencement of a proof of concept study of imetelstat.

    As of December 31, 2019, the Company had 46 employees. The Company plans to grow to a total of approximately 55 to 60 employees by year-end 2020, of which the majority will be research and development personnel.

    Conference Call

    Geron will host a conference call to discuss fourth quarter and full year 2019 financial results and 2020 milestones at 4:30 p.m. ET on Thursday, March 12, 2020.

    Participants may access the conference call live via telephone by dialing domestically +1 (866) 393-4306 or internationally +1 (734) 385-2616. The conference ID is 5528886. A live, listen-only webcast will also be available on the Company's website at www.geron.com/investors/events. If you are unable to listen to the live call, an archived webcast will be available on the Company's website for 30 days.

    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 suppression of malignant progenitor cell clone proliferation, which allows potential recovery of normal hematopoiesis. Clinical studies of imetelstat sponsored by Geron include IMerge, a Phase 2/3 trial in lower risk myelodysplastic syndromes (MDS), and IMbark, a Phase 2 trial in Intermediate-2 or High-risk myelofibrosis (MF). 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. 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) Geron's plan to complete enrollment for IMerge by the end of 2020; (ii) that Geron expects topline results from IMerge by mid-year 2022; (iii) Geron's plan to meet with the FDA in the second quarter of 2020 to discuss a potential regulatory approval path in MF and subsequently provide a decision by mid-year 2020 regarding potential late-stage development of imetelstat in MF; (iv) Geron's plan to commence a proof of concept study in 2020 in additional hematologic myeloid malignancies; (v) that the Company expects its 2020 operating expenses to be $70 to $75 million; (vi) that the Company expects that its $159.2 million in cash and marketable securities at year-end 2019 will be sufficient in 2020 to continue to fund IMerge and commence a proof of concept study; (vii) that in 2020 Geron expects to present at medical conferences: (a) more mature data from the Phase 2 IMerge clinical trial, including durability of transfusion independence and (b) further analyses of Phase 2 IMbark data that provide additional support of the potential disease-modifying activity with imetelstat treatment in MF, as well as correlation of other endpoints in the trial to the median overall survival observed in the trial; (viii) that imetelstat may have disease-modifying activity; (ix) ) that the COVID-19 pandemic may significantly impact enrollment of patients in Geron's clinical trials and/or drug supply to clinical sites; and (x) 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: (i) whether the Company overcomes all the clinical, safety, efficacy, technical, scientific, intellectual property, manufacturing and regulatory challenges to enable complete enrollment of IMerge in 2020, the availability of topline results from IMerge by mid-year 2022 and commencement of the proof of concept study; (ii) whether regulatory authorities permit the further development of imetelstat on a timely basis, or at all, without any clinical holds; (iii) whether imetelstat is demonstrated to be safe and efficacious in clinical trials; (iv) whether any future efficacy or safety results may cause the benefit-risk profile of imetelstat to become unacceptable; (v) whether there are unexpected operating expenses or events, or a change in Geron's plans that cause the $70 to $75 million 2020 financial guidance to be revised; (vi) whether the Company decides not to pursue late-stage development of imetelstat in MF; (vii) whether the MDS and MF data the Company plans to present at medical conferences strengthens the rationale for the Company to complete IMerge or pursue a Phase 3 clinical trial in MF; (viii) whether imetelstat actually demonstrates disease-modifying activity in patients; (ix) that Geron may not be able to prepare for discussions with the FDA in the second quarter of 2020, or at all, and its decision regarding potential late-stage development of imetelstat in MF, if any, may be delayed beyond mid-2020; and (x) whether imetelstat has ad