NASDAQ Framework: Geron Corporation
1: Geron Corp is a clinical-stage biopharmaceutical company focused on the research and development of cancer treatments. The company's drug in development, Imelstat, is being tested for the treatment of myelodysplastic syndromes, which are disorders of the blood, and myelofibrosis, which is a rare blood cancer affecting bone marrow. The company earns revenue through collaboration agreements, milestones, royalties, and licensing arrangements. Geron possesses various rights to this drug. The company operates as a single segment being, the development of therapeutic products for oncology. View Source2: 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 FDA-approved for the treatment of adult patients with lower-risk 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 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 www.geron.com or follow us on LinkedIn. View Source
Geron Corporation, headquartered in Foster City, California, is a commercial-stage biopharmaceutical company dedicated to transforming the treatment landscape for blood cancers. With a focus on telomerase inhibition, Geron's pioneering drug, RYTELO™ (imetelstat), has received FDA approval for treating adult patients with lower-risk myelodysplastic syndromes (MDS) with transfusion-dependent anemia. The company is also advancing imetelstat through pivotal Phase 3 clinical trials for other hematologic malignancies, including myelofibrosis. Geron's seasoned leadership team, with extensive expertise in research, clinical development, regulatory affairs, manufacturing, and commercialization, is committed to delivering innovative therapies that can change the course of blood cancers and improve patient outcomes 3456.
3: Geron Corp is a clinical-stage biopharmaceutical company focused on the research and development of cancer treatments. The company's drug in development, Imelstat, is being tested for the treatment of myelodysplastic syndromes, which are disorders of the blood, and myelofibrosis, which is a rare blood cancer affecting bone marrow. The company earns revenue through collaboration agreements, milestones, royalties, and licensing arrangements. Geron possesses various rights to this drug. The company operates as a single segment being, the development of therapeutic products for oncology. View Source4: 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 FDA-approved for the treatment of adult patients with lower-risk 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 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 www.geron.com or follow us on LinkedIn. View Source5: Geron Corporation, a late-stage clinical biopharmaceutical company, focuses on the development and commercialization of therapeutics for myeloid hematologic malignancies. It develops imetelstat, a telomerase inhibitor that is in Phase 3 clinical trials, which inhibits the uncontrolled proliferation of malignant stem and progenitor cells in myeloid hematologic malignancies for the treatment of low or intermediate-1 risk myelodysplastic syndromes and intermediate-2 or high-risk myelofibrosis. The company was incorporated in 1990 and is headquartered in Foster City, California. View Source6: With a seasoned leadership team with world-class expertise spanning research, clinical development, regulatory, manufacturing and commercial experience in hematologic malignancies, Geron is prepared to deliver on our mission to change lives by changing the course of blood cancer. View Source
7: 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 search for a new Chief Commercial Officer; (ii) Geron’s views of the progress of the commercial launch of RYTELO in the first month of launch and expectations of continued momentum going forward; (iii) Geron’s commercial organization being structured to position the company for success; 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 is successful in commercializing RYTELO (imetelstat) for the treatment of patients with LR-MDS with transfusion dependent anemia; (b) whether Geron overcomes potential delays and other adverse impacts 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; (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 safety or efficacy results of imetelstat treatment cause the benefit-risk profile of imetelstat to become unacceptable; (e) whether imetelstat actually demonstrates disease-modifying activity in patients and the ability to target the malignant stem and progenitor cells of the underlying disease; (f) that Geron may seek to raise substantial additional capital in order to continue the development and commercialization of imetelstat; (g) whether Geron meets its post-marketing requirements and commitments in the U.S. for RYTELO for the treatment of patients with LR-MDS with transfusion dependent anemia; (h) whether there are failures or delays in manufacturing or supplying sufficient quantities of imetelstat or other clinical trial materials that impact commercialization of RYTELO or the continuation of the IMpactMF trial; (i) 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 (j) whether the EMA will approve RYTELO for the treatment of patients with LR-MDS with transfusion dependent anemia and whether the FDA and EMA will approve imetelstat for other indications on the timelines expected, or at all. 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, 2024, 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. View Source8: With a seasoned leadership team with world-class expertise spanning research, clinical development, regulatory, manufacturing and commercial experience in hematologic malignancies, Geron is prepared to deliver on our mission to change lives by changing the course of blood cancer. View Source
MEDIUM RISK
Geron Corporation's financial situation can be considered medium risk due to several factors. While the company has achieved FDA approval for its drug RYTELO™ (imetelstat) and is advancing other clinical trials, there are significant risks and uncertainties that could impact its financial stability. These include potential delays and challenges in commercialization, regulatory approvals, manufacturing, and clinical trials 9. Additionally, the company may need to raise substantial additional capital to continue its development and commercialization efforts 10. Although Geron has a seasoned leadership team and institutional investors hold a significant portion of its shares, these factors do not entirely mitigate the risks associated with its ongoing and future projects 111213.
Geron Corporation's financial situation can be considered medium risk due to several factors. While the company has achieved FDA approval for its drug RYTELO™ (imetelstat) and is advancing other clinical trials, there are significant risks and uncertainties that could impact its financial stability. These include potential delays and challenges in commercialization, regulatory approvals, manufacturing, and clinical trials 9. Additionally, the company may need to raise substantial additional capital to continue its development and commercialization efforts 10. Although Geron has a seasoned leadership team and institutional investors hold a significant portion of its shares, these factors do not entirely mitigate the risks associated with its ongoing and future projects 111213.
9: 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 search for a new Chief Commercial Officer; (ii) Geron’s views of the progress of the commercial launch of RYTELO in the first month of launch and expectations of continued momentum going forward; (iii) Geron’s commercial organization being structured to position the company for success; 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 is successful in commercializing RYTELO (imetelstat) for the treatment of patients with LR-MDS with transfusion dependent anemia; (b) whether Geron overcomes potential delays and other adverse impacts 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; (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 safety or efficacy results of imetelstat treatment cause the benefit-risk profile of imetelstat to become unacceptable; (e) whether imetelstat actually demonstrates disease-modifying activity in patients and the ability to target the malignant stem and progenitor cells of the underlying disease; (f) that Geron may seek to raise substantial additional capital in order to continue the development and commercialization of imetelstat; (g) whether Geron meets its post-marketing requirements and commitments in the U.S. for RYTELO for the treatment of patients with LR-MDS with transfusion dependent anemia; (h) whether there are failures or delays in manufacturing or supplying sufficient quantities of imetelstat or other clinical trial materials that impact commercialization of RYTELO or the continuation of the IMpactMF trial; (i) 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 (j) whether the EMA will approve RYTELO for the treatment of patients with LR-MDS with transfusion dependent anemia and whether the FDA and EMA will approve imetelstat for other indications on the timelines expected, or at all. 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, 2024, 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. View Source10: 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 search for a new Chief Commercial Officer; (ii) Geron’s views of the progress of the commercial launch of RYTELO in the first month of launch and expectations of continued momentum going forward; (iii) Geron’s commercial organization being structured to position the company for success; 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 is successful in commercializing RYTELO (imetelstat) for the treatment of patients with LR-MDS with transfusion dependent anemia; (b) whether Geron overcomes potential delays and other adverse impacts 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; (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 safety or efficacy results of imetelstat treatment cause the benefit-risk profile of imetelstat to become unacceptable; (e) whether imetelstat actually demonstrates disease-modifying activity in patients and the ability to target the malignant stem and progenitor cells of the underlying disease; (f) that Geron may seek to raise substantial additional capital in order to continue the development and commercialization of imetelstat; (g) whether Geron meets its post-marketing requirements and commitments in the U.S. for RYTELO for the treatment of patients with LR-MDS with transfusion dependent anemia; (h) whether there are failures or delays in manufacturing or supplying sufficient quantities of imetelstat or other clinical trial materials that impact commercialization of RYTELO or the continuation of the IMpactMF trial; (i) 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 (j) whether the EMA will approve RYTELO for the treatment of patients with LR-MDS with transfusion dependent anemia and whether the FDA and EMA will approve imetelstat for other indications on the timelines expected, or at all. 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, 2024, 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. View Source11: Almost all investors and traders prefer to invest in shares controlled by the management of a corporation as a management company will be more likely to run the business itself and to never conduct things against the management’s desires and will always try to do what is best for their shareholders. Currently, 15.62 percent of Geron Corp. shares are owned by insiders, and 58.22 percent are held by financial institutions. Kapur Anil, the EVP, Corp Strategy & CCO at Geron Corp. (GERN) has sold 421,875 shares of firm on Jun 10 ’24 at a price of $4.64 against the total amount of $1.96 million. In another inside trade, Feller Faye, EVP, Chief Medical Officer of Geron Corp. (NASDAQ:GERN) sold 287,900 shares of the firm on Jun 10 ’24 for a total worth of $1.33 million at a price of $4.63. An inside trade which took place on Jun 04 ’24, Chairman, President and CEO of Geron Corp. SCARLETT JOHN A sold 600,000 shares of firm against total price of $2.4 million at the cost of $4.00 per share. View Source12: A look at the shareholders of Geron Corporation (NASDAQ:GERN) can tell us which group is most powerful. The group holding the most number of shares in the company, around 61% to be precise, is institutions. In other words, the group stands to gain the most (or lose the most) from their investment into the company. View Source13: With a seasoned leadership team with world-class expertise spanning research, clinical development, regulatory, manufacturing and commercial experience in hematologic malignancies, Geron is prepared to deliver on our mission to change lives by changing the course of blood cancer. View Source
YES
Geron Corporation is launching a new product offering, RYTELO™ (imetelstat), which has received FDA approval for the treatment of adult patients with lower-risk myelodysplastic syndromes (MDS) with transfusion-dependent anemia 14.
Geron Corporation is launching a new product offering, RYTELO™ (imetelstat), which has received FDA approval for the treatment of adult patients with lower-risk myelodysplastic syndromes (MDS) with transfusion-dependent anemia 14.
14: 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 FDA-approved for the treatment of adult patients with lower-risk 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 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 www.geron.com or follow us on LinkedIn. View Source
Geron Corporation's product roadmap and expansion strategy for 2024 through 2026 focuses on the commercialization and further development of its pioneering drug, RYTELO™ (imetelstat). Following the FDA approval for treating lower-risk myelodysplastic syndromes (MDS) with transfusion-dependent anemia, Geron is advancing imetelstat through pivotal Phase 3 clinical trials for other hematologic malignancies, including myelofibrosis 1516. The company is also exploring the broad potential of telomerase inhibition across multiple hematologic malignancies 17. To support these efforts, Geron is actively searching for a new Chief Commercial Officer to drive the commercial strategy and ensure continued momentum in the market 1819. The seasoned leadership team, with expertise spanning research, clinical development, regulatory, manufacturing, and commercialization, is well-prepared to execute on these ambitious plans and deliver innovative therapies that can change the course of blood cancers 20.
15: 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 FDA-approved for the treatment of adult patients with lower-risk 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 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 www.geron.com or follow us on LinkedIn. View Source16: Geron Corporation, a late-stage clinical biopharmaceutical company, focuses on the development and commercialization of therapeutics for myeloid hematologic malignancies. It develops imetelstat, a telomerase inhibitor that is in Phase 3 clinical trials, which inhibits the uncontrolled proliferation of malignant stem and progenitor cells in myeloid hematologic malignancies for the treatment of low or intermediate-1 risk myelodysplastic syndromes and intermediate-2 or high-risk myelofibrosis. The company was incorporated in 1990 and is headquartered in Foster City, California. View Source17: Geron is exploring the broad potential of telomerase inhibition across multiple hematologic malignancies. View Source18: 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 search for a new Chief Commercial Officer; (ii) Geron’s views of the progress of the commercial launch of RYTELO in the first month of launch and expectations of continued momentum going forward; (iii) Geron’s commercial organization being structured to position the company for success; 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 is successful in commercializing RYTELO (imetelstat) for the treatment of patients with LR-MDS with transfusion dependent anemia; (b) whether Geron overcomes potential delays and other adverse impacts 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; (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 safety or efficacy results of imetelstat treatment cause the benefit-risk profile of imetelstat to become unacceptable; (e) whether imetelstat actually demonstrates disease-modifying activity in patients and the ability to target the malignant stem and progenitor cells of the underlying disease; (f) that Geron may seek to raise substantial additional capital in order to continue the development and commercialization of imetelstat; (g) whether Geron meets its post-marketing requirements and commitments in the U.S. for RYTELO for the treatment of patients with LR-MDS with transfusion dependent anemia; (h) whether there are failures or delays in manufacturing or supplying sufficient quantities of imetelstat or other clinical trial materials that impact commercialization of RYTELO or the continuation of the IMpactMF trial; (i) 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 (j) whether the EMA will approve RYTELO for the treatment of patients with LR-MDS with transfusion dependent anemia and whether the FDA and EMA will approve imetelstat for other indications on the timelines expected, or at all. 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, 2024, 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. View Source19: Business WireGeron Corporation Announces Chief Commercial Officer to Depart at End of August 2024FOSTER CITY, Calif., July 23, 2024--Geron Corporation (Nasdaq: GERN), a commercial-stage biopharmaceutical company aiming to change lives by changing the course of blood cancer, today announced that Anil Kapur, Executive Vice President, Corporate Strategy and Chief Commercial Officer, will depart the Company on August 31, 2024, to pursue other interests. A search for a new Chief Commercial Officer is already underway, and in the interim, Andrew Grethlein, Ph.D., Executive Vice President, Chief OZacksGeron (GERN) to Report Q2 Earnings: What's in the Cards?Geron (GERN) is expected to primarily provide updates regarding the launch of its newly approved hematologic malignancy drug, Rytelo, in the United States when it reports second-quarter earnings.Business WireGeron to Announce Second Quarter 2024 Financial Results on August 8, 2024FOSTER CITY, Calif., July 18, 2024--Geron Corporation (Nasdaq: GERN), a commercial-stage biopharmaceutical company, today announced that it will release its second quarter 2024 financial results and business highlights before the market opens on Thursday, August 8, 2024 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 business highlights at 8:00 a.m. ET the same day. View Source20: With a seasoned leadership team with world-class expertise spanning research, clinical development, regulatory, manufacturing and commercial experience in hematologic malignancies, Geron is prepared to deliver on our mission to change lives by changing the course of blood cancer. View Source