Latest news with #GeronCorporation
Yahoo
06-08-2025
- Business
- Yahoo
Geron Corporation Reports Second Quarter 2025 Financial Results and Recent Business Highlights
Seasoned Commercial Hematology and Oncology Leader Harout Semerjian Appointed as President and CEO Achieved $49.0 million in RYTELO® net product revenue in Q2 2025 Phase 3 IMpactMF clinical trial in relapsed/refractory myelofibrosis is over 95% enrolled and expected to be fully enrolled by year-end Company to host conference call and webcast today, August 6, at 8:00 a.m. ET FOSTER CITY, Calif., August 06, 2025--(BUSINESS WIRE)--Geron Corporation (Nasdaq: GERN), a commercial-stage biopharmaceutical company aiming to change lives by changing the course of blood cancer, today reported financial results for the second quarter of 2025 and recent business highlights. In a separate press release today, the Company announced the appointment of Harout Semerjian as incoming President and CEO. "We are pleased that our sharpened sales strategy is demonstrating signs of commercial success as evidenced by solid U.S. sales and increased demand across a broadening group of treating physicians," said Dawn Carter Bir, Interim President and Chief Executive Officer of Geron. "Last quarter, we set out to increase our commercial sales team by 20% and double our medical science liaisons and I'm pleased to say we have accomplished both of these goals. We believe our investments in commercial and medical affairs will help to bolster awareness and adoption of RYTELO, our first-in-class telomerase inhibitor, and with the leadership experience Harout brings to the company, we look forward to further progress over time." Recent Business Highlights RYTELO Net product revenue of $49.0 million in the second quarter of 2025, an increase of 24% compared to the first quarter. Quarter-over-quarter demand for RYTELO in the second quarter of 2025 increased by 17%, compared to 1% in the first quarter, driven by increased demand from new patient starts. Number of ordering accounts is now over 1,000, an increase of approximately 400 year-to-date. Geron is continuing preparatory activities for the anticipated launch of RYTELO in select EU countries, following approval earlier this year. IMpactMF Phase 3 Clinical Trial Evaluating imetelstat in relapsed/refractory myelofibrosis Reached over 95% enrollment as of end of July, with full enrollment expected by year-end 2025. Interim analysis readout for overall survival expected in the second half of 2026 (when approximately 35% of patient events have occurred), and final analysis expected in the second half of 2028 (when approximately 50% of patient events have occurred). Recent Medical and Scientific Presentations Presented multiple presentations at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting and the European Hematology Association (EHA) 2025 Congress. Together, these presentations support the potential benefits of the first-in-class oligonucleotide telomerase inhibitor RYTELO (imetelstat) for a range of patients with low-to-intermediate-1 risk myelodysplastic syndromes (LR-MDS) with transfusion-dependent anemia and showcase the progress Geron is making with the ongoing IMpactMF and IMproveMF trials of imetelstat in myelofibrosis. Second Quarter 2025 Financial Results Cash and Marketable Securities As of June 30, 2025, Geron had approximately $432.6 million in cash, cash equivalents, restricted cash and marketable securities, compared to $502.9 million as of December 31, 2024. Net Loss For the three and six months ended June 30, 2025, the Company reported a net loss of $16.4 million, or $0.02 per share and $36.2 million, or $0.05 per share, compared to $67.4 million, or $0.10 per share and $122.8 million, or $0.19 per share, for the three and six months ended June 30, 2024. Revenues Total product revenue, net for the three and six months ended June 30, 2025, was $49.0 million and $88.4 million, compared to $780,000 for the three and six months ended June 30, 2024, as RYTELO was approved by the FDA in June 2024. Total net revenue for the three and six months ended June 30, 2025, was $49.0 million and $88.6 million, compared to $882,000 and $1.2 million for the three and six months ended June 30, 2024. Total net revenue includes license fees and royalties in addition to any product revenue, net. The increase in revenue is due to product revenue from U.S. sales of RYTELO, which was approved by the FDA in June 2024. Operating Expenses Total operating expenses for the three and six months ended June 30, 2025, were $61.5 million and $117.8 million, compared to $70.2 million and $126.7 million for the three and six months ended June 30, 2024. Cost of goods sold was approximately $1.2 million and $2.4 million for the three and six months ended June 30, 2025, compared to $17,000 for the three and six months ended June 30, 2024, which consisted of costs to manufacture and distribute RYTELO. Research and development expenses for the three and six months ended June 30, 2025, were $21.7 million and $36.8 million, compared to $30.8 million and $60.2 million for the same periods in 2024. The decrease in research and development expenses for the three and six months ended June 30, 2025, compared to the same periods in 2024, was primarily due to decreased clinical trial costs associated with a decrease of activity in our Phase 3 IMerge LR-MDS study after FDA approval of RYTELO in 2024, as well as manufacturing and quality costs that were capitalized in the current period now that RYTELO is approved, compared to being expensed in the prior period. Selling, general and administrative expenses for the three and six months ended June 30, 2025, were $38.6 million and $78.6 million, compared to $39.4 million and $66.5 million for the same periods in 2024. The decrease in selling, general and administrative expenses for the three months ended June 30, 2025, compared to the same period in 2024, is attributed to initial RYTELO launch costs in 2024. The increase in the six months ended June 30, 2025 is primarily due to higher personnel-related expenses from increased headcount to support the commercialization of RYTELO. 2025 Financial Guidance For fiscal year 2025, the Company maintains its previously announced expectations of total operating expenses to be in the range of approximately $270 million to $285 million, which includes non-cash items such as stock-based compensation expense, amortization of debt discounts and issuance costs, and depreciation and amortization. Based on current operating plans and assumptions, the Company believes that existing cash, cash equivalents, and marketable securities, together with anticipated net revenues from U.S. sales of RYTELO, will be sufficient to fund projected operating requirements for the foreseeable future. Conference Call Geron will host a conference call at 8:00 a.m. ET on Wednesday, August 6, 2025, to discuss business updates and second quarter 2025 financial results. A live webcast of the conference call and accompanying presentation will be available on the "Investors & Media" page of the Company's website at A replay of the webcast will be archived and available on the Company's website for 30 days. About RYTELO (imetelstat) RYTELO is an oligonucleotide telomerase inhibitor approved in the U.S. for the treatment of adult patients with LR-MDS with transfusion-dependent anemia requiring four or more red blood cell units over eight weeks who have not responded to or have lost response to or are ineligible for erythropoiesis-stimulating agents (ESAs). It is indicated to be administered as an intravenous infusion over two hours every four weeks. In addition, RYTELO is approved in the European Union as a monotherapy for the treatment of adult patients with transfusion-dependent anemia due to very low, low or intermediate risk myelodysplastic syndromes without an isolated deletion 5q cytogenetic (non-del 5q) abnormality and who had an unsatisfactory response to or are ineligible for erythropoietin-based therapy. RYTELO is a first-in-class treatment that works by inhibiting telomerase enzymatic activity. Telomeres are protective caps at the end of chromosomes that naturally shorten each time a cell divides. In LR-MDS, abnormal bone marrow cells often express the enzyme telomerase, which rebuilds those telomeres, allowing for uncontrolled cell division. Developed and exclusively owned by Geron, RYTELO is the first and only telomerase inhibitor approved by the U.S. Food and Drug Administration and the European Commission. Please see RYTELO (imetelstat) full Prescribing Information, including Medication Guide, available at About IMpactMF Phase 3 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 (MF) who are relapsed after or refractory to prior treatment with a JAK inhibitor, also referred to as relapsed/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 remission, partial remission, 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 About Geron Geron is a commercial-stage biopharmaceutical company aiming to change lives by changing the course of blood cancer. Our first-in-class telomerase inhibitor RYTELO (imetelstat) is approved in the United States and the European Union for the treatment of certain adult patients with LR-MDS with transfusion-dependent anemia. We are also conducting a pivotal Phase 3 clinical trial of imetelstat in JAK-inhibitor R/R MF, as well as studies in other hematologic malignancies. Inhibiting telomerase activity, which is increased in malignant stem and progenitor cells in the bone marrow, aims to potentially reduce proliferation and induce death of malignant cells. To learn more, visit or LinkedIn. 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 Company's beliefs regarding the long-term potential of RYTELO as an important therapeutic for eligible patients with lower-risk MDS; (ii) the strength of RYTELO's therapeutic profile and the potential for differentiated benefits associated with RYTELO's mechanism of action; (iii) the Company's beliefs, plans and expectations regarding specific opportunities and investments the Company is making, and the expected success of these efforts, to strengthen the U.S. commercial trajectory and bolster awareness and adoption of RYTELO across prescribers; (iv) the Company's beliefs and expectations regarding uptake of RYTELO across a broader group of prescribers and long-term demand, including as a result of the Company's increased commercial investments; (v) the Company's plans and expectations regarding the timing for the anticipated launch of RYTELO in select European Union, or EU, countries in 2026; (vi) that the Phase 3 IMpactMF trial in R/R MF has registrational intent and the Company's beliefs regarding the progress and status of the trial and expected timing for full enrollment occurring by year-end 2025, the interim analysis occurring in the second half of 2026 and the final analysis occurring in the second half of 2028, together with the assumptions used in making these estimates; (vii) the Company's beliefs regarding the significant market opportunity for imetelstat to treat R/R MF patients if the Phase 3 IMpactMF trial is positive and imetelstat is approved in this indication; (viii) the Company's projections for total operating expenses for fiscal year 2025; (ix) the Company's expectations that it will reach profitability without additional financing if its current internal sales and operating expense expectations are met; (x) the Company's projections and expectations regarding the sufficiency of its existing financial resources, together with U.S. sales of RYTELO, to fund its projected operating requirements for the foreseeable future; (xi) that inhibiting telomerase activity aims to potentially reduce proliferation and induce death of malignant cells; and (xii) 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 is successful in commercializing RYTELO for the treatment of certain patients with lower-risk MDS with transfusion dependent anemia and achieves market acceptance across the breadth of the eligible patient segments in RYTELO's approved indication; (b) whether the FDA and European Commission will approve imetelstat for other indications on the timelines expected, or at all; (c) Geron's plans to commercialize RYTELO in the EU and risks related to operating outside of the U.S.; (d) whether Geron overcomes potential delays and other adverse impacts that may be caused by enrollment, clinical, safety, efficacy, technical, scientific, intellectual property, manufacturing and regulatory challenges in order to have the financial resources for and meet expected timelines and planned milestones; (e) whether regulatory authorities permit the further development of imetelstat on a timely basis, or at all, without any clinical holds; (f) whether any future safety or efficacy results of RYTELO treatment cause its benefit-risk profile to become unacceptable; (g) whether imetelstat actually demonstrates disease-modifying activity in patients and the ability to target the malignant stem and progenitor cells of the underlying disease; (h) whether Geron meets its post-marketing requirements and commitments for RYTELO; (i) whether there are failures or delays in manufacturing or supplying sufficient quantities of RYTELO (imetelstat) or other clinical trial materials that impact commercialization of RYTELO or the continuation of the IMpactMF trial; (j) that the projected timing for the interim and final analyses of the IMpactMF trial may vary depending on actual enrollment and death rates in the trial; and (k) whether Geron stays in compliance with and satisfies its obligations under its debt and synthetic royalty financing agreements. 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, 2025, and subsequent 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 tables follow. GERON CORPORATION CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS Three Months Ended, June 30 Six Months Ended, June 30 (In thousands, except share and per share data) 2025 2024 2025 2024 (Unaudited) (Unaudited) (Unaudited) (Unaudited) Revenues: Product revenue, net $ 49,007 $ 780 $ 88,443 $ 780 Royalties 29 102 196 406 49,036 882 88,639 1,186 Costs and operating expenses: Cost of goods sold 1,190 17 2,396 17 Research and development 21,736 30,779 36,814 60,152 Selling, general and administrative 38,564 39,419 78,587 66,484 Total operating expenses 61,490 70,215 117,797 126,653 Loss from operations (12,454 ) (69,333 ) (29,158 ) (125,467 ) Interest income 4,656 5,332 9,808 9,571 Interest expense (8,516 ) (3,319 ) (16,716 ) (6,752 ) Other income and (expense), net (61 ) (63 ) (144 ) (125 ) Net loss $ (16,375 ) $ (67,383 ) $ (36,210 ) $ (122,773 ) Basic and diluted net loss per share: Net loss per share $ (0.02 ) $ (0.10 ) $ (0.05 ) $ (0.19 ) Shares used in computing net loss per share 666,170,358 653,904,978 666,038,645 628,699,214 CONDENSED CONSOLIDATED BALANCE SHEETS (In thousands) June 30, 2025 December 31, 2024 (Unaudited) (Note 1) Current assets: Cash, cash equivalents and restricted cash $ 79,604 $ 80,876 Current marketable securities 310,247 327,550 Other current assets 115,744 82,566 Total current assets 505,595 490,992 Noncurrent marketable securities 42,743 94,519 Property and equipment, net 1,189 1,310 Deposits and other assets 5,671 6,960 $ 555,198 $ 593,781 Current liabilities $ 64,283 $ 88,298 Noncurrent liabilities 231,384 225,163 Stockholders' equity 259,531 280,320 $ 555,198 $ 593,781 Note 1: Derived from audited financial statements included in the Company's annual report on Form 10-K for the year ended December 31, 2024. View source version on Contacts Investors Dave Borah, CFAdborah@ Media media@ Melden Sie sich an, um Ihr Portfolio aufzurufen.
Business Wire
06-08-2025
- Business
- Business Wire
Geron Corporation Reports Second Quarter 2025 Financial Results and Recent Business Highlights
FOSTER CITY, Calif.--(BUSINESS WIRE)--Geron Corporation (Nasdaq: GERN), a commercial-stage biopharmaceutical company aiming to change lives by changing the course of blood cancer, today reported financial results for the second quarter of 2025 and recent business highlights. In a separate press release today, the Company announced the appointment of Harout Semerjian as incoming President and CEO. "We are pleased that our sharpened sales strategy is demonstrating signs of commercial success as evidenced by solid U.S. sales and increased demand across a broadening group of treating physicians,' said Dawn Carter Bir, Interim President and Chief Executive Officer of Geron. 'Last quarter, we set out to increase our commercial sales team by 20% and double our medical science liaisons and I'm pleased to say we have accomplished both of these goals. We believe our investments in commercial and medical affairs will help to bolster awareness and adoption of RYTELO, our first-in-class telomerase inhibitor, and with the leadership experience Harout brings to the company, we look forward to further progress over time.' Recent Business Highlights RYTELO Net product revenue of $49.0 million in the second quarter of 2025, an increase of 24% compared to the first quarter. Quarter-over-quarter demand for RYTELO in the second quarter of 2025 increased by 17%, compared to 1% in the first quarter, driven by increased demand from new patient starts. Number of ordering accounts is now over 1,000, an increase of approximately 400 year-to-date. Geron is continuing preparatory activities for the anticipated launch of RYTELO in select EU countries, following approval earlier this year. IMpactMF Phase 3 Clinical Trial Evaluating imetelstat in relapsed/refractory myelofibrosis Reached over 95% enrollment as of end of July, with full enrollment expected by year-end 2025. Interim analysis readout for overall survival expected in the second half of 2026 (when approximately 35% of patient events have occurred), and final analysis expected in the second half of 2028 (when approximately 50% of patient events have occurred). Recent Medical and Scientific Presentations Presented multiple presentations at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting and the European Hematology Association (EHA) 2025 Congress. Together, these presentations support the potential benefits of the first-in-class oligonucleotide telomerase inhibitor RYTELO (imetelstat) for a range of patients with low-to-intermediate-1 risk myelodysplastic syndromes (LR-MDS) with transfusion-dependent anemia and showcase the progress Geron is making with the ongoing IMpactMF and IMproveMF trials of imetelstat in myelofibrosis. Second Quarter 2025 Financial Results Cash and Marketable Securities As of June 30, 2025, Geron had approximately $432.6 million in cash, cash equivalents, restricted cash and marketable securities, compared to $502.9 million as of December 31, 2024. Net Loss For the three and six months ended June 30, 2025, the Company reported a net loss of $16.4 million, or $0.02 per share and $36.2 million, or $0.05 per share, compared to $67.4 million, or $0.10 per share and $122.8 million, or $0.19 per share, for the three and six months ended June 30, 2024. Revenues Total product revenue, net for the three and six months ended June 30, 2025, was $49.0 million and $88.4 million, compared to $780,000 for the three and six months ended June 30, 2024, as RYTELO was approved by the FDA in June 2024. Total net revenue for the three and six months ended June 30, 2025, was $49.0 million and $88.6 million, compared to $882,000 and $1.2 million for the three and six months ended June 30, 2024. Total net revenue includes license fees and royalties in addition to any product revenue, net. The increase in revenue is due to product revenue from U.S. sales of RYTELO, which was approved by the FDA in June 2024. Operating Expenses Total operating expenses for the three and six months ended June 30, 2025, were $61.5 million and $117.8 million, compared to $70.2 million and $126.7 million for the three and six months ended June 30, 2024. Cost of goods sold was approximately $1.2 million and $2.4 million for the three and six months ended June 30, 2025, compared to $17,000 for the three and six months ended June 30, 2024, which consisted of costs to manufacture and distribute RYTELO. Research and development expenses for the three and six months ended June 30, 2025, were $21.7 million and $36.8 million, compared to $30.8 million and $60.2 million for the same periods in 2024. The decrease in research and development expenses for the three and six months ended June 30, 2025, compared to the same periods in 2024, was primarily due to decreased clinical trial costs associated with a decrease of activity in our Phase 3 IMerge LR-MDS study after FDA approval of RYTELO in 2024, as well as manufacturing and quality costs that were capitalized in the current period now that RYTELO is approved, compared to being expensed in the prior period. Selling, general and administrative expenses for the three and six months ended June 30, 2025, were $38.6 million and $78.6 million, compared to $39.4 million and $66.5 million for the same periods in 2024. The decrease in selling, general and administrative expenses for the three months ended June 30, 2025, compared to the same period in 2024, is attributed to initial RYTELO launch costs in 2024. The increase in the six months ended June 30, 2025 is primarily due to higher personnel-related expenses from increased headcount to support the commercialization of RYTELO. 2025 Financial Guidance For fiscal year 2025, the Company maintains its previously announced expectations of total operating expenses to be in the range of approximately $270 million to $285 million, which includes non-cash items such as stock-based compensation expense, amortization of debt discounts and issuance costs, and depreciation and amortization. Based on current operating plans and assumptions, the Company believes that existing cash, cash equivalents, and marketable securities, together with anticipated net revenues from U.S. sales of RYTELO, will be sufficient to fund projected operating requirements for the foreseeable future. Conference Call Geron will host a conference call at 8:00 a.m. ET on Wednesday, August 6, 2025, to discuss business updates and second quarter 2025 financial results. A live webcast of the conference call and accompanying presentation will be available on the 'Investors & Media' page of the Company's website at A replay of the webcast will be archived and available on the Company's website for 30 days. About RYTELO (imetelstat) RYTELO is an oligonucleotide telomerase inhibitor approved in the U.S. for the treatment of adult patients with LR-MDS with transfusion-dependent anemia requiring four or more red blood cell units over eight weeks who have not responded to or have lost response to or are ineligible for erythropoiesis-stimulating agents (ESAs). It is indicated to be administered as an intravenous infusion over two hours every four weeks. In addition, RYTELO is approved in the European Union as a monotherapy for the treatment of adult patients with transfusion-dependent anemia due to very low, low or intermediate risk myelodysplastic syndromes without an isolated deletion 5q cytogenetic (non-del 5q) abnormality and who had an unsatisfactory response to or are ineligible for erythropoietin-based therapy. RYTELO is a first-in-class treatment that works by inhibiting telomerase enzymatic activity. Telomeres are protective caps at the end of chromosomes that naturally shorten each time a cell divides. In LR-MDS, abnormal bone marrow cells often express the enzyme telomerase, which rebuilds those telomeres, allowing for uncontrolled cell division. Developed and exclusively owned by Geron, RYTELO is the first and only telomerase inhibitor approved by the U.S. Food and Drug Administration and the European Commission. Please see RYTELO (imetelstat) full Prescribing Information, including Medication Guide, available at About IMpactMF Phase 3 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 (MF) who are relapsed after or refractory to prior treatment with a JAK inhibitor, also referred to as relapsed/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 remission, partial remission, 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 About Geron Geron is a commercial-stage biopharmaceutical company aiming to change lives by changing the course of blood cancer. Our first-in-class telomerase inhibitor RYTELO (imetelstat) is approved in the United States and the European Union for the treatment of certain adult patients with LR-MDS with transfusion-dependent anemia. We are also conducting a pivotal Phase 3 clinical trial of imetelstat in JAK-inhibitor R/R MF, as well as studies in other hematologic malignancies. Inhibiting telomerase activity, which is increased in malignant stem and progenitor cells in the bone marrow, aims to potentially reduce proliferation and induce death of malignant cells. To learn more, visit or LinkedIn. 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 Company's beliefs regarding the long-term potential of RYTELO as an important therapeutic for eligible patients with lower-risk MDS; (ii) the strength of RYTELO's therapeutic profile and the potential for differentiated benefits associated with RYTELO's mechanism of action; (iii) the Company's beliefs, plans and expectations regarding specific opportunities and investments the Company is making, and the expected success of these efforts, to strengthen the U.S. commercial trajectory and bolster awareness and adoption of RYTELO across prescribers; (iv) the Company's beliefs and expectations regarding uptake of RYTELO across a broader group of prescribers and long-term demand, including as a result of the Company's increased commercial investments; (v) the Company's plans and expectations regarding the timing for the anticipated launch of RYTELO in select European Union, or EU, countries in 2026; (vi) that the Phase 3 IMpactMF trial in R/R MF has registrational intent and the Company's beliefs regarding the progress and status of the trial and expected timing for full enrollment occurring by year-end 2025, the interim analysis occurring in the second half of 2026 and the final analysis occurring in the second half of 2028, together with the assumptions used in making these estimates; (vii) the Company's beliefs regarding the significant market opportunity for imetelstat to treat R/R MF patients if the Phase 3 IMpactMF trial is positive and imetelstat is approved in this indication; (viii) the Company's projections for total operating expenses for fiscal year 2025; (ix) the Company's expectations that it will reach profitability without additional financing if its current internal sales and operating expense expectations are met; (x) the Company's projections and expectations regarding the sufficiency of its existing financial resources, together with U.S. sales of RYTELO, to fund its projected operating requirements for the foreseeable future; (xi) that inhibiting telomerase activity aims to potentially reduce proliferation and induce death of malignant cells; and (xii) 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 is successful in commercializing RYTELO for the treatment of certain patients with lower-risk MDS with transfusion dependent anemia and achieves market acceptance across the breadth of the eligible patient segments in RYTELO's approved indication; (b) whether the FDA and European Commission will approve imetelstat for other indications on the timelines expected, or at all; (c) Geron's plans to commercialize RYTELO in the EU and risks related to operating outside of the U.S.; (d) whether Geron overcomes potential delays and other adverse impacts that may be caused by enrollment, clinical, safety, efficacy, technical, scientific, intellectual property, manufacturing and regulatory challenges in order to have the financial resources for and meet expected timelines and planned milestones; (e) whether regulatory authorities permit the further development of imetelstat on a timely basis, or at all, without any clinical holds; (f) whether any future safety or efficacy results of RYTELO treatment cause its benefit-risk profile to become unacceptable; (g) whether imetelstat actually demonstrates disease-modifying activity in patients and the ability to target the malignant stem and progenitor cells of the underlying disease; (h) whether Geron meets its post-marketing requirements and commitments for RYTELO; (i) whether there are failures or delays in manufacturing or supplying sufficient quantities of RYTELO (imetelstat) or other clinical trial materials that impact commercialization of RYTELO or the continuation of the IMpactMF trial; (j) that the projected timing for the interim and final analyses of the IMpactMF trial may vary depending on actual enrollment and death rates in the trial; and (k) whether Geron stays in compliance with and satisfies its obligations under its debt and synthetic royalty financing agreements. 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, 2025, and subsequent 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 tables follow. Note 1: Derived from audited financial statements included in the Company's annual report on Form 10-K for the year ended December 31, 2024. Expand
Business Wire
28-07-2025
- Business
- Business Wire
Geron Plans to Announce Second Quarter 2025 Financial Results on August 6, 2025
FOSTER CITY, Calif.--(BUSINESS WIRE)--Geron Corporation (Nasdaq: GERN), a commercial stage biopharmaceutical company, today announced that it will release its second quarter financial results and business highlights before the market opens on Wednesday, August 6, 2025 via press release, which will be available on the Company's website at Geron will host a conference call to discuss the financial results as well as business highlights at 8:00 a.m. Eastern Time. A live webcast of the conference call and related presentation will be available on the Company's website at An archive of the webcast will be available on the Company's website for 30 days. About Geron Geron is a commercial-stage biopharmaceutical company aiming to change lives by changing the course of blood cancer. Our first-in-class telomerase inhibitor RYTELO® (imetelstat) is approved in the United States and the European Union for the treatment of certain adult patients with lower-risk myelodysplastic syndromes (LR-MDS) with transfusion dependent anemia. We are also conducting a pivotal Phase 3 clinical trial of imetelstat in JAK-inhibitor relapsed/refractory myelofibrosis (R/R MF), as well as studies in other myeloid hematologic malignancies. Inhibiting telomerase activity, which is increased in malignant stem and progenitor cells in the bone marrow, aims to reduce proliferation and induce death of malignant cells. To learn more, visit or follow us on LinkedIn.
Business Wire
19-05-2025
- Business
- Business Wire
Geron Corporation Reports Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)
FOSTER CITY, Calif.--(BUSINESS WIRE)--Geron Corporation (Nasdaq: GERN), a commercial stage biopharmaceutical company, today reported that it has granted equity awards covering an aggregate of 411,000 shares of its common stock, consisting of stock options to purchase an aggregate of 274,000 shares of common stock, and restricted stock units ('RSUs') representing an aggregate of 137,000 shares of common stock, to six newly hired employees as an inducement material to their acceptance of employment with Geron. The stock options and RSUs were granted on May 16, 2025. The stock options have an exercise price of $1.27 per share, which is equal to the closing price of Geron common stock on the grant date, 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 of each employee 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 RSUs vest as to 25% of the award on each anniversary of the grant date, subject to continued employment with Geron through the applicable vesting dates. The equity awards were granted by the Compensation Committee of Geron's Board of Directors in accordance with Nasdaq Listing Rule 5635(c)(4) and are subject to the terms and conditions of Geron's 2018 Inducement Award Plan and the forms of stock option and RSU agreements under the plan. About Geron Geron is a commercial-stage biopharmaceutical company aiming to change lives by changing the course of blood cancer. Our first-in-class telomerase inhibitor RYTELO® (imetelstat) is approved in the United States and the European Union for the treatment of certain adult patients with lower-risk myelodysplastic syndromes (LR-MDS) with transfusion dependent anemia. We are also conducting a pivotal Phase 3 clinical trial of imetelstat in JAK-inhibitor relapsed/refractory myelofibrosis (R/R MF), as well as studies in other myeloid hematologic malignancies. Inhibiting telomerase activity, which is increased in malignant stem and progenitor cells in the bone marrow, aims to reduce proliferation and induce death of malignant cells. To learn more, visit or follow us on LinkedIn.
Yahoo
13-05-2025
- Business
- Yahoo
Why Geron Corporation (GERN) Is The Best Low Priced Biotech Stock to Buy Now
We recently published a list of . In this article, we are going to take a look at where Geron Corporation (NASDAQ:GERN) stands against other best low priced biotech stocks to buy now. On May 8, Michael Yee, Senior Biotech Analyst at Jefferies, appeared on CNBC to discuss how tariffs and policy risks are pressuring the biotech industry, while simultaneously iterating that low valuations in the sector may present buying opportunities once the uncertainty clears. Talking about the broader impact of tariffs on the biotech sector, he said that the estimated tariff rate would be around 50%, while the negative EPS impact would be around -4-5%. According to Yee, the sector is facing several challenges that have caused significant pressure and anxiety among biotech investors. One of them is definitely sector-specific tariffs. The 50% estimation is a manageable impact for many of the biotech companies, but there are also other challenges being floated. Another factor is the most favored nations that could drop drug prices by as much as 40% to 50%, making it a related impact. Assuming all these impacts are going into place, there are definitely uncertain downside risks to the model. However, the takeaway is that many of these stocks are down more than 20-30% and, in fact, are trading at a decade-low P/E multiple. Therefore, while these uncertainties may be out there over the next few weeks or months, the stocks are expected to move higher after that. If we look back at some other stocks with tariffs, many are obviously higher off the bottoms. They have thus fallen to an attractive valuation, which is why there might be an opportunity to buy them. READ ALSO: Recession Resistant Investing: 10 Best Grocery Stocks To Buy Now and 11 Most Promising Future Stocks According to Hedge Funds. Shedding light on the most favored nation policy, Yee said it is not new. It is also not a new concept that the US, on average, pays around 40% to 50% more for drugs as compared to the basket of other, say, five to ten major developed nations. The country also gets its drugs faster, and is the home of innovation. Many of the pharmaceutical company executives over the past few weeks pointed out that most of those countries are also facing downside issues because of R&D investments, getting the drugs years later, and obviously, the countries aren't benefiting from access to any of these drugs. However, the United States government does negotiate 15-20 drugs per year and will be doing that for the next decade. We sifted through stock screeners, financial media reports, and ETFs to compile a list of 50 low-priced biotech stocks and then chose the top 10 with the highest number of hedge fund holders as of Q4 2024. We sourced the hedge fund sentiment data from Insider Monkey's database. The list is ordered in ascending order of hedge fund sentiment. Note: The data was recorded on May 9. Why are we interested in the stocks that hedge funds pile into? The reason is simple: our research has shown that we can outperform the market by imitating the top stock picks of the best hedge funds. Our quarterly newsletter's strategy selects 14 small-cap and large-cap stocks every quarter and has returned 363.5% since May 2014, beating its benchmark by 208 percentage points (). A close-up of a laboratory technician in a laboratory, measuring a newly developed biopharmaceutical drug. Stock Price: $1.18 Number of Hedge Fund Holders: 46 Geron Corporation (NASDAQ:GERN) is a biotechnology company that develops Imetelstat, a telomerase inhibitor in hematologic myeloid malignancies. It focuses on oncology-focused therapeutic products. On May 7, Gil Blum, an analyst from Needham, maintained a Buy rating on Geron Corporation (NASDAQ:GERN) with an unchanged price target of $5.00. While the company's Rytelo sales underwent a drop, the analyst highlighted positive indicators, such as improved utilization in earlier treatment lines and rising patient demand. These trends point to a potential sales performance improvement in H2 2025. Geron Corporation (NASDAQ:GERN) is also expanding its commercial team by around 20% as a strategic step to increase product awareness. The analyst expects this move to positively affect sales later in 2025. In addition, the company has a strong financial position, ending fiscal Q1 2025 with $458 million and maintaining its operational expenditure guidance for the year. Overall, GERN ranks 1st on our list of the best low priced biotech stocks to buy now. While we acknowledge the potential for GERN as an investment, our conviction lies in the belief that some AI stocks hold greater promise for delivering higher returns and doing so within a shorter time frame. There is an AI stock that went up since the beginning of 2025, while popular AI stocks lost around 25%. If you are looking for an AI stock that is more promising than GERN but trades at less than 5 times its earnings, check out our report about this cheapest AI stock. READ NEXT: 20 Best AI Stocks To Buy Now and 30 Best Stocks to Buy Now According to Billionaires. Disclosure: None. This article is originally published at Insider Monkey. Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
