Machine learning predictions based on historical earnings data and price patterns
1-Day Prediction
+0.15%
$1.57
100% positive prob.
5-Day Prediction
+6.17%
$1.67
100% positive prob.
20-Day Prediction
+21.40%
$1.91
95% positive prob.
SEC 8-K filings with transcript text
Aug 6, 2026 · 100% conf.
1D
+0.15%
$1.57
Act: -5.73%
5D
+6.17%
$1.67
Act: -2.55%
20D
+21.40%
$1.91
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Exhibit 99.1
Geron Corporation Reports Second Quarter 2026 Financial Results and Recent Business Highlights
August 5, 2026
Achieved $57.5 million in RYTELO® (imetelstat) net product revenue in Q2 2026, an increase of 11% compared to Q1 2026
Reiterated 2026 RYTELO net product revenue and total operating expenses expected to be in the ranges of $220 million to $240 million, and $230 million to $240 million, respectively
Ended Q2 2026 with cash, cash equivalents, restricted cash and marketable securities of $327 million
Broadened leadership team with the appointment of Chinmaya Rath as Chief Business Officer
Company to host conference call and webcast today, August 5, 2026, at 8:00 a.m. ET
FOSTER CITY, Calif., Aug. 05, 2026 (GLOBE NEWSWIRE) – 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 2026 and recent business highlights.
“We are executing a focused strategy to build a leading hematology company, which starts with bringing RYTELO to more eligible patients impacted by LR-MDS in the U.S. Our team delivered a third consecutive quarter of RYTELO demand growth, and in the first half of 2026, grew net revenue by 24% while decreasing total operating expenses by 4% compared to the same period last year,” said Harout Semerjian, President and Chief Executive Officer of Geron. “With an estimated 8,000 second-line LR-MDS patients in the U.S., we see a meaningful opportunity to continue growing demand for RYTELO in 2026 and beyond. We also have the opportunity to create additional long-term value by expanding access to RYTELO in other geographies, advancing our Phase 3 IMpactMF trial in relapsed/refractory myelofibrosis and pursuing strategic innovation to develop and commercialize new therapies for people living with blood cancers.”
Recent Business Highlights
•
Reported RYTELO net product revenue of $57.5 million in the second quarter of 2026.
•
Grew RYTELO demand by 5% in the second quarter 2026, compared to the first quarter 2026.
•
Increased ordering accounts by roughly 8% in the second quarter 2026 to approximately 1,575.
•
Presented the first real-world evidence study of RYTELO in patients with lower-risk myelodysplastic syndromes (LR-MDS) at the European Hematology Association (EHA) 2026 Congress. The retrospective portion of the investigator-sponsored study, conducted at the Moffitt Cancer Center, reported safety and clinical efficacy of imetelstat in advanced, heavily transfusion-dependent patients with LR-MDS, including patients with extensive prior therapies and after luspatercept failure. The efficacy, safety and tolerability observed were generally consistent with findings from the Phase 3 IMerge trial in a broader patient population.1
•
Presented two abstracts studying imetelstat in relapsed/refractory myelofibrosis at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting, including an updated overall survival analysis from the Phase 2 IMbark trial compared with real-world data.
•
Broadened the leadership team with the appointment of Chinmaya Rath as Chief Business Officer.
Second Quarter 2026 Financial Results
Cash and Marketable Securities
As of June 30, 2026, Geron had approximately $326.9 million in cash, cash equivalents, restricted cash and marketable securities, compared to $341.0 million as of March 31, 2026, which provides the Company with cash for the foreseeable future.
Net Loss
For the three months ended June 30, 2026, the Company reported a net loss of $16.7 million, or $0.02 per share, compared to $16.4 million, or $0.02 per share, for the three months ended June 30, 2025. The increase in net loss is directly attributable to non-cash inventory-related expenses, which were partially offset by an increase in RYTELO net product revenue for the quarter.
Revenues
Total product revenue, net for the three months ended June 30, 2026, was $57.5 million, compared to $49.0 million for the three months ended June 30, 2025.
Costs and Operating Expenses
Total costs and operating expenses for the three months ended June 30, 2026, were $70.0 million, compared to $61.5 million for the three months ended June 30, 2025. The increase is primarily due to non-cash inventory-related expenses.
Cost of goods sold was approximately $9.2 million for the three months ended June 30, 2026, compared to $1.2 million for the three months ended June 30, 2025, which consisted of costs to manufacture and distribute RYTELO. The increase is primarily due to non-cash inventory-related expenses.
Research and development expenses for the three months ended June 30, 2026, were $22.0 million, compared to $21.7 million for the same period in 2025. The increase in research and development expenses was a result of investments in manufacturing and was partially offset by lower headcount costs fr
Feb 25, 2026
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Exhibit 99.1
Geron Corporation Reports Fourth Quarter and Full Year 2025 Financial Results and Recent Business Highlights
Achieved $48 million and $184 million in RYTELO® (imetelstat) net product revenue in Q4 2025 and full year 2025, respectively
Reported total operating expenses of $255 million for full year 2025, within the previous guidance range
Reiterated 2026 RYTELO net product revenue and total operating expenses expected in the ranges of $220 million to $240 million, and $230 million to $240 million, respectively
Ended 2025 with cash, cash equivalents, restricted cash and marketable securities of roughly $401 million
Company to host conference call and webcast today, February 25, at 8:00 a.m. ET
FOSTER CITY, Calif., February 25, 2026 – 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 fourth quarter and full year of 2025 and recent business highlights.
“Strategic actions we have taken in the second half of 2025 position Geron to drive RYTELO demand growth and invest to create value while lowering our total operating expenses year-over-year. In 2026, we are laser-focused on executing our commercial strategy,” said Harout Semerjian, President and Chief Executive Officer of Geron. “The commercial opportunity for RYTELO in second-line lower-risk MDS is significant and supported by its FDA label, NCCN Guidelines and a growing body of scientific evidence. In the second half of 2026, we look forward to the IMpactMF interim analysis in relapsed/refractory myelofibrosis and the first data from real-world experience trials focused on the use of RYTELO in LR-MDS. Our priorities are to drive U.S. commercial growth, pursue pathways to bring RYTELO to patients outside the U.S., remain financially disciplined, and evaluate opportunistic innovation as we transform Geron into a leading, sustainable hematology company.”
Recent Business Highlights
•
Achieved RYTELO net product revenue of $48.0 million in the fourth quarter of 2025, and $183.6 million in full year 2025.
•
Grew RYTELO demand by 9% in the fourth quarter 2025 compared to the third quarter 2025.
•
Increased ordering accounts by 150 in the fourth quarter 2025 to approximately 1,300.
•
Aligned to support over 10 investigator-sponsored and real-world experience trials focusing on RYTELO’s mechanistic studies, combinations and sequencing, earlier-line use and new settings. Initial data is expected in the second half of 2026.
•
Announced three new medical publications:
•
New research published in Blood Cancer Journal exploring the impact of prior therapy on clinical activity in LR-MDS patients treated with imetelstat.
•
New peer-reviewed article in Leukemia examining changes in molecular disease markers LR-MDS patients.
•
New manuscript in Haematologica exploring potential improvements in patient-reported outcomes in patients
treated with imetelstat in the Phase 3 IMerge clinical trial.
•
Expanded the scientific body of evidence supporting the potential of RYTELO in lower-risk myelodysplastic
syndromes/neoplasms (LR-MDS) at the 2025 American Society of Hematology (ASH) Annual Meeting reinforcing RYTELO as a differentiated new treatment option.
•
Oral presentation from pooled analyses of the IMerge population suggests that treatment-emergent cytopenias may
reflect on-target effects associated with meaningful clinical outcomes, including hemoglobin increases and transfusion independence in LR-MDS.
Fourth Quarter and Full Year 2025 Financial Results
Cash and Marketable Securities
As of December 31, 2025, Geron had approximately $401.1 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 months and twelve months ended December 31, 2025, the Company reported a net loss of $31.1 million, or $85.8 million, compared to $25.4 million or $174.6 million for the three months and twelve months ended December 31, 2024.
Revenues
Total product revenue net, for the three months and twelve months ended December 31, 2025, was $48.0 million and $183.6 million, compared to $47.5 million and $76.5 million for the three months and twelve months ended December 31, 2024.
Total revenues, for the three months and twelve months ended December 31, 2025, was $48.0 million and $183.9 million, compared to $47.5 million and $77.0 million for the three months and twelve months ended December 31, 2024. Total revenues include license fees and royalties in addition to product revenue, net.
Costs and Operating Expenses
Total costs and operating expenses, for the three months and twelve months ended December 31, 2025, were $75.8 million and $254.7 million, compared to $67.6 million and $250.7 million for the three months and twelve months ended December 31, 2024.
Cost of goods sold was
Nov 5, 2025
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Document
Exhibit 99.1
Geron Corporation Reports Third Quarter 2025 Financial Results and Recent Business Highlights
Achieved $47.2 million in RYTELO® net product revenue in Q3 2025
Completed enrollment in Phase 3 IMpactMF clinical trial evaluating imetelstat in relapsed/refractory myelofibrosis
Strengthened leadership team with appointment of Chief Commercial Officer and additional key executives
Announced one oral and four poster presentations accepted at the American Society of Hematology (ASH) 2025 Annual Meeting
Company to host conference call and webcast today, November 5, at 8:00 a.m. ET
FOSTER CITY, Calif., November 5, 2025 – 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 third quarter of 2025 and recent business highlights.
"The high unmet need in lower-risk MDS is well known, and RYTELO is a therapy with a novel mechanism of action and the potential to significantly impact the treatment paradigm. There is work ahead of us to fully maximize the value of this therapy and ensure RYTELO reaches more patients,” said Harout Semerjian, President and Chief Executive Officer of Geron. “Geron is positioned, with our realigned leadership team, to strengthen commercial execution, increase both physician and patient awareness, and drive RYTELO sales in the U.S. We look forward to presenting meaningful data at ASH, enhancing our partnerships with the MDS community and conducting the interim analysis for the IMpactMF trial. Our actions are focused on creating value for our patients and shareholders.”
Recent Business Highlights
•Achieved net product revenue of $47.2 million in the third quarter of 2025.
•Demand was down 3% quarter-over-quarter, with opportunities to elevate brand awareness and clinical value communications.
•Number of ordering accounts is now approximately 1,150, an increase of approximately 150 quarter-over-quarter.
•Increased RYTELO presence at major hematology forums, such as the Society of Hematologic Oncology (SOHO) 2025 Annual Meeting.
•Announced that two abstracts highlighting data from the IMerge clinical trial in lower-risk MDS were accepted for presentation at the ASH 2025 Annual Meeting, including one oral presentation on the potential correlation between imetelstat clinical response rates and treatment-emergent cytopenias.
Clinical Pipeline
•Completed enrollment of 320 patients in the IMpactMF Phase 3 clinical trial evaluating imetelstat in relapsed/refractory myelofibrosis in September 2025.
•Expect IMpactMF interim analysis readout for overall survival in the second half of 2026 (when approximately 35% of patient events have occurred), and final analysis in the second half of 2028 (when approximately 50% of patient events have occurred).
•Announced three abstracts were accepted at the ASH 2025 Annual Meeting highlighting clinical data from Geron’s IMbark and IMproveMF clinical trials and the investigator-sponsored IMpress clinical trial.
Corporate Updates
•Announced the appointment of Ahmed ElNawawi (“Nawawi") as Executive Vice President, Chief Commercial Officer to advance the company’s strategic priorities, including driving growth, maximizing the potential of RYTELO, and strengthening the foundation for potential future portfolio expansion.
•Appointed three additional executives with expertise across technical operations, investor relations and corporate affairs, and portfolio management, further strengthening the company’s commercial, operational and development capabilities.
Third Quarter 2025 Financial Results
Cash and Marketable Securities
As of September 30, 2025, Geron had approximately $421.5 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 months ended September 30, 2025, the Company reported a net loss of $18.4 million, or $0.03 per share, compared to $26.4 million, or $0.04 per share, for the three months ended September 30, 2024.
Revenues
Total product revenue, net for the three months ended September 30, 2025, was $47.2 million , compared to $28.2 million for the three months ended September 30, 2024.
Total revenues for the three months ended September 30, 2025 was $47.2 million, compared to $28.3 million for the three months ended September 30, 2024.Total revenues include license fees and royalties in addition to product revenue, net.
Costs and Operating Expenses
Total costs and operating expenses for the three months ended September 30, 2025 were $61.1 million, compared to $56.5 million for the three months ended September 30, 2024.
Cost of goods sold was approximately $1.0 million for the three months ended September 30, 2025, compared to $456,000 for the three months ended September 30, 2024, which consisted of costs to manufacture and distribut
Aug 6, 2025
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Document
Exhibit 99.1
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 6, 2025 – 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
•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 de
May 7, 2025
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Document
Exhibit 99.1
Geron Corporation Reports First Quarter 2025 Financial Results and Recent Business Highlights
Reported $39.4 million in RYTELO® (imetelstat) net product revenue in Q1 2025; revenue impacted by inventory dynamics, with Q1 demand relatively flat
Granted marketing authorization of RYTELO by the European Commission (EC); planning for commercial launch in select EU countries 2026
Reached approximately 85% enrollment in the Phase 3 IMpactMF clinical trial for treatment of relapsed/refractory myelofibrosis; interim analysis remains expected in 2H 2026
Company to host conference call and webcast today, May 7 at 8:00 a.m. ET
FOSTER CITY, Calif., May 7, 2025 – 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 first quarter of 2025 and recent business highlights.
"We are confident in the long-term potential of RYTELO as an important therapeutic for eligible patients with lower-risk-MDS and are sharply focused on maximizing the U.S. commercial opportunity,” said Dawn Carter Bir, Interim President and Chief Executive Officer of Geron. “We have received positive feedback from clinicians who have utilized RYTELO, supporting its strong therapeutic profile. We’ve identified specific opportunities and are making focused investments that we believe will strengthen the U.S. commercial trajectory. We expect our increased commercial investments to bolster uptake across a broader group of prescribers and drive long-term demand. We are also expanding our medical affairs efforts to support increased awareness and education. Looking ahead, our Phase 3 IMpactMF trial evaluating overall survival with imetelstat in patients with JAKi relapsed/refractory myelofibrosis (R/R MF), which we believe represents a tremendous expansion opportunity, is progressing well and the event-driven interim analysis is still expected in the second half of 2026.”
Recent Business Highlights
•Continued first year of U.S. commercialization of RYTELO, with net product revenue of $39.4 million in the first quarter of 2025. Demand for RYTELO in the 13-week period through the week ending March 28 increased 1% compared to the prior 13 weeks.
•Received marketing authorization for RYTELO from the European Commission (EC) as a monotherapy for the treatment of adult patients with transfusion-dependent (TD) anemia due to very low, low, or intermediate risk myelodysplastic syndromes (lower-risk MDS or LR-MDS) without an isolated deletion 5q cytogenetic (non-del 5q) abnormality and who had an unsatisfactory response to or are ineligible for erythropoietin-based therapy (ESAs).
◦Launch planning is underway and Geron expects to commercialize RYTELO in select EU countries commencing in 2026.
•Reached 85% enrollment in Phase 3 IMpactMF clinical trial evaluating imetelstat in patients with JAKi R/R MF. We continue to expect an interim analysis readout for overall survival in the second half of 2026 (when approximately 35% of patient events have occurred), and final analysis in the second half of 2028 (when approximately 50% of patient events have occurred).
◦The Company believes there is a significant market opportunity for imetelstat to treat JAKi R/R MF patients based on its unique mechanism of action, strong clinical data to date, and the substantial size of the addressable patient population, if the trial is positive and imetelstat is approved in this indication.
◦Clinical data from the Phase 2 study showed a strong signal regarding prolonged survival and resolution of bone marrow fibrosis in patients treated with imetelstat, suggesting the potential for disease modification.
First Quarter 2025 Financial Results
As of March 31, 2025, Geron had approximately $457.5 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 months ended March 31, 2025, the Company reported a net loss of $19.8 million, or $0.03 per share, compared to $55.4 million, or $0.09 per share, for the three months ended March 31, 2024.
Revenues
Total product revenue, net for the three months ended March 31, 2025, was $39.4 million. There was no product revenue in the prior year period, as RYTELO was approved by the FDA in June 2024. The decline in net product revenue compared to the three months ended December 31, 2024, which was $47.5 million, was primarily due to inventory drawdown among RYTELO distributors from the fourth quarter of 2024 into the first quarter of 2025.
Total net revenue for the three months ended March 31, 2025, was $39.6 million, compared to $0.3 million for the same period in 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
Feb 26, 2025
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Exhibit 99.1
Geron Corporation Reports Fourth Quarter and Full Year 2024 Financial Results and Recent Business Highlights
Achieved $47.5 million in RYTELO™ (imetelstat) net product revenue in Q4 2024 and $76.5 million since commercial launch at the end of June 2024, following FDA approval
Expect to reach profitability without additional financing if current internal sales and operating expenses expectations are met
FOSTER CITY, Calif., February 26, 2025 -- 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 fourth quarter and full year 2024 and recent business highlights.
"2024 was a terrific year for Geron and for RYTELO, our first-in-class telomerase inhibitor, which we believe represents a highly differentiated treatment with blockbuster potential in the high unmet need, lower-risk MDS patient population. We also continued to progress our development efforts in relapsed/refractory myelofibrosis, which could potentially double our commercial opportunity if our IMpactMF Phase 3 trial reads out positively and we are approved in this indication. From a financial perspective, we ended the year with a strong cash position, and Q3 and Q4 revenues exceeded our expectations. Heading into 2025, we are excited by the strategic and leadership changes we put in place early in the launch, which we believe will position us to increase our revenue growth trajectory and more fully capture the significant commercial opportunity over the next several quarters,” said John A. Scarlett, M.D., Geron’s Chairman and Chief Executive Officer.
Recent Business Highlights
• Continued execution on U.S. commercial launch, with net product revenue for RYTELO (imetelstat) of $47.5 million in the fourth quarter of 2024 and $76.5 million since launch at the end of June 2024, following approval by the U.S. Food and Drug Administration (FDA).
• Received positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) in December 2024 recommending approval of RYTELO for the treatment of certain adult patients with transfusion-dependent anemia due to lower-risk MDS. Subject to receiving regulatory approval, which is expected in the first half of 2025, Geron is preparing to commercialize RYTELO in select EU countries in 2026.
• Achieved approximately 80% enrollment in the Phase 3 IMpactMF trial evaluating imetelstat in patients with relapsed/refractory myelofibrosis (R/R MF). Based on our current planning assumptions for enrollment and event (death) rates in the trial, we now expect the interim analysis for overall survival may occur in the second half of 2026 (when approximately 35% of planned enrolled patients have died) and the final analysis may occur in the second half of 2028 (when approximately 50% of planned enrolled patients have died).
• Presented new data at the 66th American Society for Hematology (ASH) Annual Meeting in December 2024, including analyses of IMerge Phase 3 data suggesting clinical activity of imetelstat in patients with lower-risk MDS regardless of type or number of prior therapies and Phase 1 findings from IMproveMF suggesting tolerability of imetelstat in combination with ruxolitinib as a potential frontline therapy in patients with MF.
Fourth Quarter 2024 Financial Results
As of December 31, 2024, we had approximately $502.9 million in cash, cash equivalents, restricted cash and marketable securities.
Net Loss
For the three and twelve months ended December 31, 2024, the Company reported a net loss of $25.4 million , or $0.04 per share, and $174.6 million, or $0.27 per share, respectively, compared to $52.0 million, or $0.09 per share, and $184.1 million, or $0.32 per share, respectively, for the three and twelve months ended December 31, 2023.
Revenues
Total product revenue, net for the three and twelve months ended December 31, 2024, was $47.5 million and $76.5 million, respectively. There was no product revenue in the prior year periods, given that RYTELO was aproved by the FDA in June 2024.
Total net revenue for the three and twelve months ended December 31, 2024, was $47.5 million and $77.0 million, respectively, compared to $23,000 and $237,000 for the same periods in 2023. 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 twelve months ended December 31, 2024, were $67.6 million and $250.7 million, respectively, compared to $54.3 million and $194.2 million for the same periods in 2023.
Cost of goods sold was approximately $783,000 and $1.3 million for the three and twelve months ended December 31, 2024, respectively, which consisted of costs to manu
Jan 13, 2025
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Corporate Presentation Our mission is to change lives by changing the course of blood cancer January 2025 Our mission is to change lives by changing the course of blood cancer
Nov 7, 2024
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Exhibit 99.1
Geron Corporation Reports Third Quarter 2024 Financial Results and Recent Business Highlights
Achieved $28.2 million in RYTELO™ (imetelstat) net product revenue in first full quarter of sales
Received $250 million in gross proceeds from synthetic royalty and debt financings with Royalty Pharma and Pharmakon Advisors, with access to an additional $125 million in debt
FOSTER CITY, Calif., November 7, 2024 -- 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 third quarter of 2024 and recent business highlights.
“This has been a transformative year for Geron, following our first FDA approval and commercial launch of RYTELO in June. The initial full quarter of product revenue from our U.S. launch exceeded our expectations and demonstrates strong execution as a commercial company. These results also reflect the high unmet need in lower-risk MDS and the compelling value proposition of RYTELO for hematologists and patients, giving us confidence in future continued demand and momentum for RYTELO,” said John A. Scarlett, M.D., Geron’s Chairman and Chief Executive Officer. “We were also pleased to announce this morning the completion of important synthetic royalty and debt financing transactions with Royalty Pharma and Pharmakon Advisors. We believe that the favorable terms in these transactions reflect the significant commercial potential of RYTELO and provide us with critical flexibility to fuel continued growth and invest in our future.”
Recent Business Highlights
• Strong execution in the first full quarter of U.S. launch, with net product revenue for RYTELO (imetelstat) of $28.2 million in the third quarter of 2024.
• In November 2024, completed synthetic royalty and debt financing transactions to strengthen our cash position and further solidify our balance sheet while providing strategic flexibility to invest in our future. We entered into a synthetic royalty agreement with Royalty Pharma providing $125 million of capital in exchange for tiered royalty payments. We also entered into a 5-year, senior term loan agreement with Pharmakon for up to $250 million, from which we have drawn a first tranche of $125 million, a portion of which was used to fully repay amounts owed under our existing loan with Hercules Capital, Inc. and Silicon Valley Bank ($86.5 million), which has now been terminated, with the ability to borrow another $125 million prior to the end of 2025, subject to specified conditions.
• Jim Ziegler appointed as Executive Vice President, Chief Commercial Officer in September 2024, to spearhead Geron’s global commercial strategy and operations, lead the commercial organization and be responsible for driving growth of RYTELO. Mr. Ziegler brings more than 25 years of commercial experience in the biopharmaceutical industry, spanning leadership, strategic and operational roles in both large and smaller organizations.
• New data to be presented at upcoming American Society for Hematology (ASH) Annual Meeting highlights the potential of imetelstat in myeloid hematologic malignancies( please view ASH press release for more details).
Upcoming Milestones
• We expect review of the Marketing Authorization Application (MAA) for RYTELO in lower-risk MDS by the Committee for Medicinal Products for Human Use (CHMP) could be completed in late 2024 or early 2025, with potential approval by the European Medicines Agency (EMA) in the first half of 2025. We are continuing to prepare for the potential launch of RYTELO in the EU, and subject to regulatory approval, are planning to commercialize RYTELO in select EU markets commencing in 2026.
• We expect an interim analysis from the Phase 3 IMpactMF trial in patients with relapsed/refractory MF may occur in early 2026 (when approximately 35% of planned enrolled patients have died) and the final analysis may occur in early 2027 (when approximately 50% of planned enrolled patients have died), based on our most recent planning assumptions for enrollment and death rates in the trial.
Third Quarter 2024 Financial Results
As of September 30, 2024, we had approximately $378.9 million in cash, cash equivalents, restricted cash and marketable securities. On a pro forma basis, including gross proceeds from the upfront payment under the Royalty Pharma Agreement and the first tranche of the Pharmakon loan and after repayment of our existing debt, we had approximately $542.4 million in cash, cash equivalents, restricted cash, and marketable securities as of September 30, 2024.
Net Loss
For the three and nine months ended September 30, 2024, the Company reported a net loss of $26.4 million, or $0.04 per share, and $149.2 million, or $0.23 per share, respectively, compared to $44.8 million, or $0.08 per share and $132.2 million, or $0.23 per share, respectively, for the three and nine m
Aug 8, 2024
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Exhibit 99.1
Geron Corporation Reports Second Quarter 2024 Financial Results and Business Highlights
U.S. commercial launch of RYTELO™ (imetelstat) began in June 2024 for patients with lower-risk myelodysplastic syndromes (LR-MDS) with transfusion-dependent anemia who are relapsed/refractory to or ineligible for etythropoiesis-stimulating agents (ESAs), regardless of ring sideroblast (RS) status
NCCN Guidelines® updated to include the use of RYTELO in both RS+ and RS- patients for second-line treatment of symptomatic anemia in patients with lower-risk MDS and for first-line treatment of patients who are ESA ineligible (serum EPO >500 mU/mL)
FOSTER CITY, Calif., August 8, 2024 -- Geron Corporation (Nasdaq: GERN), a commercial-stage biopharmaceutical company aiming to change lives by changing the course of blood cancer, today reported financial results and business highlights for the second quarter of 2024.
“We are thrilled to have begun the launch of RYTELO, our first commercial product, in June, and are encouraged by the early success we are seeing and the reception from the medical community over these first six weeks ," said John A. Scarlett, M.D., Geron's Chairman and Chief Executive Officer. "Our field teams have mobilized efficiently and have already interacted with approximately 60% of our top decile 1-4 accounts across the community and academic settings. This has contributed to gratifying uptake – as of July 31, 2024, we estimate that approximately 160 patients have received RYTELO, which is encouraging given the very early stage of this launch. Further, the MDS NCCN Guidelines, which guide clinical decision-making, prescriber behavior and reimbursement decisions, were updated at the end of July to include RYTELO as a Category 1 and 2A treatment of symptomatic anemia in patients with lower-risk MDS. With the introduction of RYTELO as a new therapeutic option, we are seeing increasing dialogue among hematologists rethinking treatment approaches for eligible patients with lower-risk MDS with transfusion-dependent anemia, regardless of ring sideroblast status, and we believe that RYTELO can become part of the standard-of-care for these patients.”
Business Highlights
• Received approval on June 6, 2024 from the U.S. Food & Drug Administration (FDA) of RYTELO for the treatment of adult patients with low- to intermediate-1 risk myelodysplastic syndromes (LR-MDS) with transfusion-dependent (TD) 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).
• Launched RYTELO commercially in the U.S., with both dosage strengths available for prescribers to order from specialty distributors as of June 27, 2024.
• The National Comprehensive Cancer Network® (NCCN®) updated the MDS NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) to include RYTELO for the treatment of symptomatic anemia in patients with LR-MDS. For both RS+ and RS- patients, RYTELO has a Category 1 designation for second-line treatment regardless of first-line treatment and a Category 2A designation for first-line treatment of patients who are ESA ineligible (serum EPO >500 mU/mL).
• Achieved approximately 70% enrollment in the Phase 3 IMpactMF trial of imetelstat as of August 2024, which has a primary endpoint of overall survival, in patients with myelofibrosis (MF) who are relapsed/refractory to JAK-inhibitors. As previously disclosed, based on the most recent planning assumptions for enrollment and death rates in the trial, an interim analysis is expected in early 2026 (when approximately 35% of planned enrolled patients have died) and final analysis is expected in early 2027 (when approximately 50% of planned enrolled patients have died).
• Expanded the dose level 4 cohort (imetelstat 9.4 mg/kg) in the Part 1 dose-finding stage of the Phase 1 IMproveMF study evaluating imetelstat as a combination therapy with ruxolitinib in patients with
frontline MF. This followed a unanimous decision by the study’s Safety Evaluation Team (SET), who in July 2024 reviewed data from the first three patients in the dose level 4 cohort and identified no dose-limiting toxicities.
Second Quarter 2024 Financial Results
As of June 30, 2024 the Company had approximately $430.4 million in cash, cash and equivalents and marketable securities.
Net Loss
For the three and six months ended June 30, 2024, the Company reported a net loss of $67.4 million, or $0.10 per share, and $122.8 million, or $0.19 per share, respectively, compared to $49.2 million, or $0.09 per share and $87.3 million, or $0.16 per share, respectively, for the three and six months ended June 30, 2023.
Revenues
Total product revenue, net for the three and six months ended June 30, 2024, was approximately $780,000.
Total net revenues for the three and six months ended June 30, 2024, were $882,000 and $1.2 mi
May 2, 2024
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Exhibit 99.1
Geron Corporation Reports First Quarter 2024 Financial Results and Business Highlights
June 16, 2024 PDUFA date for imetelstat NDA for the treatment of transfusion-dependent anemia in adult patients with lower-risk MDS
FOSTER CITY, Calif., May 2, 2024 -- Geron Corporation (Nasdaq: GERN), a late-stage clinical biopharmaceutical company developing investigational first-in-class telomerase inhibitor, imetelstat, to treat hematologic malignancies, today reported financial results and business highlights for the first quarter 2024.
“Since the FDA ODAC’s 12 to 2 vote in favor of the clinical benefit/risk profile of imetelstat for the treatment of transfusion-dependent anemia in patients with lower-risk MDS in March, we have continued working with the FDA as they complete their review of our New Drug Application, which has a June 16, 2024 PDUFA target action date,” said John A. Scarlett, M.D., Chairman and Chief Executive Officer. “We are actively preparing for a successful launch of imetelstat in the U.S., if approved, including most recently onboarding our sales force last month, refining our market research and completing buildout of our enterprise capabilities and systems to support our transition from a clinical to commercial-stage company.”
U.S. Commercial Preparation
Geron has now completed onboarding its commercial team, with the buildout of the full sales organization in April. Other commercial preparations for the U.S. are ongoing and on target, including enhancing and/or establishing company processes and systems to support an expected commercial launch, refining market research in TD LR-MDS, and engaging in marketing, commercial access, payer, and reimbursement preparatory efforts.
Clinical Development Update
The Phase 3 IMpactMF clinical trial, which has a primary endpoint of overall survival, is ongoing in myelofibrosis patients who are relapsed/refractory to JAK inhibitors. Last month, the data monitoring committee evaluated unblinded data and recommended the clinical trial continue. In addition, the Company reviewed enrollment rates and blinded death rates, which are lower than anticipated based on initial planning assumptions. Accordingly, guidance is being updated to extend the timelines by half a year, with the interim analysis now expected in early 2026 and the final analysis expected in early 2027.
First Quarter 2024 Financial Results
As of March 31, 2024, the Company had approximately $465 million in cash and marketable securities, including proceeds from an underwritten public offering of common stock and a pre-funded warrant in March 2024 for net proceeds of approximately $141 million.
For the first quarter of 2024, the Company reported a net loss of $55.4 million, or $0.09 per share, compared to $38.1 million, or $0.07 per share, for the first quarter of 2023.
Revenues for the first quarter of 2024 were $304,000, compared to $21,000 for the same period in 2023. Royalty revenues in 2024 and 2023 primarily reflect estimated royalties from sales of cell-based research products from the Company’s divested stem cell assets.
Total operating expenses for the first quarter of 2024 were $56.4 million, compared to $40.1 million for the same period in 2023. Research and development expenses for the first quarter of 2024 were $29.4 million, compared to $27.2 million for the same period in 2023. The increase in research and development expenses for the three months ended March 31, 2024, compared to the same period in 2023, primarily reflects the net result of higher
manufacturing costs due to the timing of imetelstat manufacturing batches and increased personnel-related expenses for additional headcount. We expect research and development expenses to remain consistent in the future as we support IMpactMF, IMproveMF and IMpress, as well as the long-term treatment and follow-up of remaining patients in IMerge. General and administrative expenses for the first quarter of 2024 were $27.1 million, compared to $12.9 million for the same period in 2023. The increase in general and administrative expenses for the three months ended March 31, 2024, compared to the same period in 2023, primarily reflects new costs for commercial preparatory activities and higher personnel-related expenses for additional headcount.
Interest income for the first quarter of 2024 was $4.2 million, compared to $3.9 million for the same period in 2023. The increase in interest income for the three months ended March 31, 2024, compared to the same period in 2023, primarily reflects a larger marketable securities portfolio with the receipt of net cash proceeds from the underwritten offering completed in March 2024, as well as higher yields from recent marketable securities purchases.
Interest expense for the first quarter of 2024 was $3.4 million, compared to $1.9 million for the same period in 2023. The increase in interest expense for the three months ended Mar
Feb 28, 2024
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Geron Corporation Reports Business Highlights and Fourth Quarter and Full Year 2023 Financial Results
June 16, 2024 PDUFA date for imetelstat NDA for the treatment of transfusion-dependent anemia in adult patients with lower-risk MDS
FOSTER CITY, Calif., February 28, 2024 -- Geron Corporation (Nasdaq: GERN), a late-stage clinical biopharmaceutical company developing investigational first-in-class telomerase inhibitor, imetelstat, to treat hematologic malignancies, today reported business highlights and financial results for the fourth quarter and full year 2023.
“Geron’s progress and execution throughout 2023 has paved the way for a potentially transformational 2024, as we plan for the transition to becoming a commercial company,” said John A. Scarlett, M.D., Chairman and Chief Executive Officer. “We believe that we are in a strong position for value creation, based on our differentiated product candidate, the potential for significant commercial opportunities in transfusion-dependent, lower-risk MDS and relapsed/refractory MF, the excellence and experience of our employees, and the strength of our balance sheet to support a potential U.S. launch.”
2023 Business Highlights
Transfusion-Dependent Lower-Risk Myelodysplastic Syndromes (TD LR-MDS)
• In January 2023, Geron reported positive top-line results from the pivotal IMerge Phase 3 clinical trial evaluating imetelstat in patients with TD LR-MDS. Additional data including subgroup analyses and patient-reported outcomes were subsequently reported at the European Hematology Association Annual Meeting in June 2023 and at the American Society of Hematology Annual Meeting and published in The Lancet in December 2023.
• In August 2023, the U.S. Food & Drug Administration (FDA) accepted the New Drug Application (NDA) for imetelstat for the treatment of TD anemia in adult patients with low- to intermediate-1 risk myelodysplastic syndromes, who have failed to respond, or have lost response to, or are ineligible for erythropoiesis-stimulating agents (ESAs). The FDA assigned a Prescription Drug User Fee Act (PDUFA) action date of June 16, 2024 to the NDA.
• On January 30, 2024, the FDA provided notice in the Federal Register that it has scheduled a public Oncologic Drugs Advisory Committee to be held virtually on March 14, 2024, as part of the imetelstat NDA review.
• In September 2023, the European Medicines Agency (EMA) validated the Marketing Authorization Application (MAA) for imetelstat in the same proposed indication as the NDA.
Myelofibrosis
• In December 2023, Geron achieved fifty percent enrollment in the Phase 3 IMpactMF clinical trial investigating imetelstat versus best available therapy (BAT) in patients with intermediate-2 or high-risk Myelofibrosis (MF) who are relapsed/refractory myelofibrosis (R/R MF) to Janus kinase (JAK) inhibitor treatment.
• In January 2024, dosing in the Phase 1 IMproveMF study evaluating imetelstat as a combination therapy with ruxolitinib in patients with intermediate-2 or high-risk MF (frontline MF) was escalated to the third of four doses following a decision by the study’s independent Safety Evaluation Team (SET).
Corporate
• In November 2023, Geron appointed Gaurav Aggarwal, M.D., a prominent investor in the life sciences sector for more than two decades who has a history of expertise in financial and corporate strategy, as well as business development, to Geron’s Board of Directors.
• In August and September 2023, respectively, Geron appointed Scott Samuels as Executive Vice President, Chief Legal Officer and Corporate Secretary, and Michelle Robertson as Executive Vice President, Chief Financial Officer and
Treasurer. Both Mr. Samuels and Ms. Robertson join Geron with a track record of excellence in commercial-stage biopharmaceutical companies.
Anticipated Upcoming Milestones
• U.S. commercial launch of imetelstat upon potential FDA approval (PDUFA date June 16, 2024) for the treatment of transfusion-dependent anemia in adult patients with LR-MDS who have failed to respond, or have lost response to, or are ineligible for ESAs.
• Review of the imetelstat MAA for the same indication as the NDA expected to be completed in early 2025. Subject to approval by the European Commission, EU commercial launch of imetelstat could occur in 2025.
• Interim analysis from the Phase 3 IMpactMF trial in R/R MF expected in the first half of 2025, with a final analysis from the study expected in the first half of 2026.
U.S. Commercial Preparation
Throughout 2023, Geron completed several long-lead time pre-commercial activities, including securing a global trademark for the imetelstat brand name; finalizing third party logistics, our distribution network, patient support providers; and onboarding highly experienced commercial and medical affairs teams. Other pre-commercial preparations for the U.S. are ongoing, including enhancing and/or establishing company processes and syst
Jan 8, 2024
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Company Logo Enhancing the Lives of Patients with Hematologic Malignancies Corporate Presentation January 2024
Nov 2, 2023
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Geron Corporation Reports Business Highlights and Third Quarter 2023 Financial Results
Imetelstat is currently under regulatory review by the FDA and EMA for the treatment of transfusion-dependent anemia in adult patients with lower risk MDS
Planning is ongoing for a potential commercial launch in the U.S. in mid-2024
FOSTER CITY, Calif., November 2, 2023 -- Geron Corporation (Nasdaq: GERN), a late-stage clinical biopharmaceutical company developing a first-in-class telomerase inhibitor, imetelstat, to treat hematologic malignancies, today reported business highlights and financial results for the third quarter of 2023.
“This quarter, we continued to make important progress and build momentum along our planned path to develop and commercialize imetelstat, which is now the first telomerase inhibitor to be under review by both the FDA and EMA for potential regulatory approval,” said John A. Scarlett, M.D., Chairman and Chief Executive Officer. “We see lower risk MDS as a very compelling commercial opportunity, with few durable treatment options and significant need for large patient segments such as patients without sideroblasts (RS-) and those with high transfusion burden. We believe, if approved, that imetelstat could play a meaningful role in this treatment landscape.”
Dr. Scarlett continued, “We believe that we are in a strong position to execute upon a potential launch in the U.S., bolstered by an experienced leadership team and with our talented commercial and medical affairs leadership teams fully onboarded. Additionally, with approximately $382 million on the balance sheet as of the end of the quarter, and expected available resources, we have the financial resources to fund a potential successful launch in the U.S. and our planned operations through the end of Q3 2025.”
Business Highlights
• Received acceptance from the U.S. Food & Drug Administration (FDA) of the New Drug Application (NDA) submitted for imetelstat for the treatment of transfusion-dependent anemia in adult patients with low- to intermediate-1 risk myelodysplastic syndromes (MDS), or lower risk MDS, who have failed to respond, or have lost response to, or are ineligible for erythropoiesis-stimulating agents (ESAs). The FDA assigned a Prescription Drug User Fee Act (PDUFA) action date of June 16, 2024. In addition, the FDA informed the Company that it is currently planning to hold an advisory committee meeting as part of the NDA review.
• Submitted the Marketing Authorization Application (MAA) for imetelstat in the same lower risk MDS indication as in the NDA and received validation from the European Medicines Agency (EMA) that the application is under regulatory review by the European Committee for Medicinal Products for Human Use (CHMP) under the centralized procedure. Review of the MAA is expected to be completed by the end of 2024.
• Presented encore data and analyses from the IMerge Phase 3 clinical trial evaluating imetelstat in patients with lower risk MDS at the Society of Hematologic Oncology Annual Meeting. New analyses from this trial are also planned at the American Society of Hematology (ASH) Annual Meeting, on which a separate press release will be issued.
• Escalated to the second dose cohort in the Phase 1 ImproveMF study evaluating imetelstat as a combination therapy with ruxolitinib in patients with frontline myelofibrosis (MF) following a unanimous decision by the study’s Safety Evaluation Team (SET), who reviewed the first cohort (3 patients) data and identified no dose-limiting toxicities.
• Appointed Michelle Robertson as Executive Vice President, Chief Financial Officer and Treasurer, following Olivia Bloom’s retirement. Ms. Roberston brings to Geron over 30 years of financial and commercial operations experience. Prior to joining, she served as the Chief Financial Officer and Treasurer of Editas Medicine, a CRISPR genome editing company, where she raised $500M in capital over three years to support the company’s research transition into late-stage clinical development. Before that, she served as Chief Financial Officer of Momenta Pharmaceuticals, Inc. from 2018 until 2020, leading the finance team through a strategic restructure, before its acquisition by Johnson & Johnson. Prior to joining Momenta,
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Ms. Robertson held multiple finance and commercial operations roles of increasing responsibility.
Third Quarter 2023 Financial Results
As of September 30, 2023, the Company had $381.9 million in cash, cash equivalents, and marketable securities. In the third quarter of 2023, the Company received $28.3 million upon the cash exercise of outstanding warrants. As of September 30, 2023, warrants remaining outstanding are exercisable for potential future proceeds of $3.2 million. Based on the Company’s current operating plans and expectations regarding the timing of regulatory approval and commercialization of imetelstat in the United States (U.S.) in the first
Aug 3, 2023
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Geron Corporation Reports Business Highlights and Second Quarter 2023 Financial Results
Submitted U.S. New Drug Application in lower risk MDS in June 2023
Additional data and analyses from IMerge Phase 3 presented at medical meetings further strengthen value proposition and differentiation of imetelstat
Potential U.S. commercial launch in lower risk MDS expected in first half of 2024
FOSTER CITY, Calif., August 3, 2023 -- Geron Corporation (Nasdaq: GERN), a late-stage clinical biopharmaceutical company developing a first-in-class telomerase inhibitor, imetelstat, to treat hematologic malignancies, today reported business highlights and financial results for the second quarter of 2023.
“We progressed our business significantly this quarter, as we evolve into a commercial company. Most notably, we submitted the first New Drug Application to the FDA for a telomerase inhibitor, a pioneering achievement that reflects our teams’ dedication to ground-breaking and innovative drug development,” said John A. Scarlett, M.D., Chairman and Chief Executive Officer. “Importantly, new data and analyses from IMerge Phase 3 presented at ASCO and EHA further strengthen the value proposition of imetelstat by highlighting differentiated attributes of the drug, such as unprecedented continuous durable transfusion independence, responses across subgroups, patient-reported outcomes of improved fatigue and strong evidence of disease-modifying activity.”
Dr. Scarlett also noted, “With approximately $400 million on the balance sheet as of the end of the quarter, we have the financial resources to not only fund a potential successful launch, but also support the first year of launch.”
Business Highlights
• Submitted New Drug Application (NDA) to the FDA based on results from IMerge Phase 3 in lower risk myelodysplastic syndromes (MDS).
• Presented new data and analyses from IMerge Phase 3 at ASCO and EHA reporting robust durability of transfusion independence, evidence of disease-modifying activity and favorable fatigue patient-reported outcomes in imetelstat-treated lower risk MDS patients versus placebo.
• Initiated Expanded Access Protocol (EAP) in June 2023, making imetelstat available to clinicians and patients prior to potential FDA approval.
• Achieved >40% enrollment in IMpactMF, Geron’s Phase 3 trial of imetelstat in patients with myelofibrosis (MF) relapsed/refractory to JAK-inhibitors. Based on projected planning assumptions for enrollment and death rates in the trial, interim analysis is expected in the first half of 2025 and final analysis is expected in the first half of 2026.
• Dosed first patient in June 2023 in the investigator-led Phase 2 IMpress trial, evaluating imetelstat in patients with relapsed/refractory acute myeloid leukemia or higher risk MDS.
• Obtained and reported significant market research insights highlighting a potentially substantial commercial opportunity for imetelstat in lower risk MDS.
• Appointed Scott Samuels as Executive Vice President, Chief Legal Officer and Corporate Secretary, following Stephen Rosenfield’s retirement at the end of July 2023. Mr. Samuels recently served as the General Counsel of BeiGene, Ltd., where he built a large, global legal and compliance team, oversaw launches of three internally developed drug products in the U.S., Europe and China and development of a global healthcare compliance program, and led key strategic transactions with Amgen Inc., Novartis AG and Celgene Corporation (now Bristol Myers Squibb Inc.).
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Financial Resources to Support Potential Commercial Launch of Imetelstat in Lower Risk Myelodysplastic Syndromes (MDS)
As of June 30, 2023, the Company had $400.2 million in cash, cash equivalents, restricted cash and marketable securities. In the second quarter of 2023, the Company received $17.8 million upon the cash exercise of outstanding warrants. As of June 30, 2023, warrants remaining outstanding are exercisable for potential future proceeds of $31.5 million. Based on the Company’s current operating plans and expectations regarding the timing of regulatory approval and commercialization of imetelstat in the United States (U.S.) in the first half of 2024, as well as revised guidance on interim and final analyses from IMpactMF, Geron projects that its existing financial resources plus potential future proceeds from remaining warrants outstanding and estimated revenues from commercialization will be sufficient to fund its projected operating requirements through the end of 2025.
Second Quarter 2023 Financial Results
Revenues for the three and six months ended June 30, 2023, were $29,000 and $50,000, respectively, compared to $73,000 and $196,000 for the comparable 2022 periods. Revenues in both years primarily reflect estimated royalties from sales of cell-based research products from the Company’s divested stem cell assets.
Total operating expenses
May 11, 2023
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Geron Corporation Reports First Quarter 2023 Financial Results and Business Highlights
Planned submission of U.S. New Drug Application on track for June 2023
Additional data and analyses from IMerge Phase 3 expected to be presented at upcoming medical meetings further strengthen differentiating qualities of imetelstat
Preparations for potential commercial launch in the U.S. ongoing
FOSTER CITY, Calif., May 11, 2023 -- Geron Corporation (Nasdaq: GERN), a late-stage clinical biopharmaceutical company developing a first-in-class telomerase inhibitor, imetelstat, to treat hematologic malignancies, today reported business updates and financial results for the first quarter of 2023.
“We believe that imetelstat has a compelling commercial value proposition and is well-positioned to become a standard of care in lower risk MDS, based on unprecedented broad durability of transfusion independence in the IMerge Phase 3 trial and high unmet need in this patient population,” said John A. Scarlett, M.D., Chairman and Chief Executive Officer. “We are on track to submit a New Drug Application in the U.S. next month and are preparing for a potential U.S. commercial launch in the first half of 2024. Further, we are planning to submit a Marketing Authorization Application in the EU in the second half of 2023 and preparing for an EU commercial launch by the end of 2024.”
Dr. Scarlett also noted, “We also continue to make progress on recruiting and enrolling patients into IMpactMF, the first and only Phase 3 study of JAK inhibitor relapsed/refractory myelofibrosis patients with a primary endpoint of overall survival. If this trial is successful, we expect imetelstat to become a transformational agent for these patients.”
Dr. Scarlett added, “As of the end of the quarter, we had over $400 million on the balance sheet, which we believe provides the financial resources to operate the company through the end of the third quarter of 2025. This means we expect to launch in lower risk MDS without being compromised by lack of funding, while also supporting IMpactMF and our other ongoing earlier stage programs.”
Financial Resources to Support Potential Commercial Launch of Imetelstat in Lower Risk Myelodysplastic Syndromes (MDS)
As of March 31, 2023, the Company had $409.2 million in cash and marketable securities. In January 2023, the Company closed an underwritten public offering of common stock and pre-funded warrant, plus the full exercise of the underwriters’ option to purchase additional shares of common stock, for net cash proceeds of $213.3 million, after deducting the underwriting discount and other offering expenses. In addition, the Company received $59.8 million upon the cash exercise of outstanding warrants in the first quarter of 2023. Based on the Company’s current operating plans and expectations regarding the timing of regulatory approval and commercialization of imetelstat in the United States (U.S.) in the first half of 2024, Geron projects that its existing financial resources will be sufficient to fund its projected operating requirements through the end of the third quarter of 2025.
First Quarter 2023 Financial Results
For the first quarter of 2023, the Company reported a net loss of $38.1 million, or $0.07 per share, compared to $30.1 million, or $0.09 per share, for the first quarter of 2022.
Revenues for the first quarter of 2023 were $21,000 compared to $123,000 for the same period in 2022. Royalty revenues in 2023 and 2022 primarily reflect estimated royalties from sales of cell-based research products from the Company’s divested stem cell assets.
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Total operating expenses for the first quarter of 2023 were $40.1 million, compared to $28.8 million for the same period in 2022. Research and development expenses for the first quarter of 2023 were $27.2 million, compared to $22.1 million for the same period in 2022. The increase in research and development expenses for the three months ended March 31, 2023, compared to the same period in 2022, primarily reflects higher clinical trial costs related to supporting IMerge Phase 3 and IMpactMF and increased personnel-related expenses for additional headcount. General and administrative expenses for the first quarter of 2023 were $12.9 million compared to $6.7 million for the same period in 2022. The increase in general and administrative expenses for the three months ended March 31, 2023, compared to the same period in 2022, primarily reflects new costs for commercial preparatory activities and higher personnel-related expenses for additional headcount.
Interest income for the first quarter of 2023 was $3.9 million, compared to $112,000 for the same period in 2022. The increase in interest income for the three months ended March 31, 2023, compared to the same period in 2022, primarily reflects higher yields on the Company’s marketable securities as a result of rising interes
Apr 20, 2023
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22nd Annual Needham Virtual Healthcare Conference Slides
Mar 16, 2023
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Geron Corporation Reports Fourth Quarter and Full Year 2022 Financial Results and Upcoming Milestones
Positive Phase 3 Top-Line Results in Lower Risk MDS Reported in January 2023
Planned 2023 Regulatory Submissions in the U.S. and EU On Track
Preparations for Potential Commercial Launch in U.S. Ongoing
FOSTER CITY, Calif., March 16, 2023 -- Geron Corporation (Nasdaq: GERN), a late-stage clinical biopharmaceutical company developing a first-in-class telomerase inhibitor, imetelstat, to treat hematologic malignancies, today reported business updates, upcoming milestones and financial results for the fourth quarter and year ended December 31, 2022.
“With positive top-line results having been reported for IMerge Phase 3, we now have a charted path toward several potentially significant regulatory and commercial catalysts, which we expect will further enhance the value of imetelstat. As the first step, we are focused on completing and submitting a U.S. New Drug Application (NDA) and a European Marketing Authorization Application (MAA) for imetelstat in lower risk MDS in 2023,” said John A. Scarlett, M.D., Chairman and Chief Executive Officer. “Also in 2023, we will be implementing many of the long-lead time operational items needed to prepare for potential commercial launch of imetelstat in lower risk MDS in the U.S., such as establishing key sales-related systems, engaging a third-party logistics provider, manufacturing sufficient commercial supply of drug for launch and beyond, and hiring deeply experienced commercial talent.”
Dr. Scarlett also noted, “On top of our efforts to advance imetelstat toward commercialization in lower risk MDS, we continue to make progress on recruiting and enrolling patients into IMpactMF, our imetelstat Phase 3 trial in relapsed/refractory MF. Reaching a sufficient number of events to enable an interim analysis readout from this trial in 2024 depends on sufficient enrollment, as well as the rate at which actual death events occur during the course of the trial. We expect to have a better view on timing of the interim analysis in the second half of this year.”
Dr. Scarlett added, “As a result of robust and compelling data from IMerge Phase 3, we believe there will be renewed attention on telomerase inhibition as an oncology approach. Thus, we have positioned our exploratory programs in other hematologic malignancies to provide data over the next several years to add strategic value to the imetelstat franchise.”
Financial Resources to Support Potential Commercial Launch of Imetelstat in Lower Risk Myelodysplastic Syndromes (MDS)
The Company ended 2022 with $173.1 million in cash and marketable securities. In January 2023, the Company closed an underwritten public offering of common stock and pre-funded warrant, plus the full exercise of the underwriters’ option to purchase additional shares of common stock, for net cash proceeds of $213.3 million, after deducting the underwriting discount and other offering expenses. In addition, the Company received $59.8 million upon the cash exercise of outstanding warrants in January and February 2023.
Key Upcoming Milestones Expected
• Additional presentations at medical conferences and publication in peer-reviewed journal of data on imetelstat in lower risk MDS from IMerge Phase 3, including evidence of potential disease modification – throughout 2023.
• Complete submission of the NDA for imetelstat in lower risk MDS – in mid-2023.
• Complete submission of an MAA for imetelstat in lower risk MDS – in second half of 2023.
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• Assuming NDA acceptance on a timely basis, FDA approval of the NDA and U.S. commercial launch – in first half of 2024.
• Assuming a 14 month review timeline, approval of the MAA and commercial launch in the EU – by the end of 2024.
• Interim analysis from IMpactMF Phase 3 trial in relapsed/refractory myelofibrosis (MF) – 2024.
• Significant life cycle management program readouts – 2023-2025.
Planned Next Steps for Imetelstat in Lower Risk MDS
Geron plans to present additional data from IMerge Phase 3 at medical meetings later this year. These potential presentations are expected to report data that may be indicative of the potential for disease modification with imetelstat, including exploring correlations of decreases in mutation burden and abnormal bone marrow cytogenetics with clinical responses; the results of patient reported outcomes (PRO) in the trial; hTERT and telomerase activity biomarker data and continued follow-up of patients for durability of transfusion independence. In addition, the Company plans to submit the IMerge Phase 3 data for publication in a peer-reviewed journal in 2023.
Imetelstat has been granted Fast Track designation by the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with transfusion dependent anemia due to Low or Intermediate-1 risk MDS that is not associated
Jan 4, 2023
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Unless the context indicates otherwise, the terms “we,” “us” and “our” refer to Geron Corporation, a Delaware corporation, and its subsidiary on a consolidated basis. This Exhibit 99.1 includes trademarks, service marks and trade names owned by us or other companies. All trademarks, service marks and trade names included in this Exhibit 99.1 are the property of their respective owners.
This Exhibit 99.1 contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, or the Securities Act, and Section 21E of the Securities Exchange Act of 1934, as amended, or the Exchange Act. These statements relate to future events or to our future operating or financial performance and involve known and unknown risks, uncertainties and other factors which may cause our actual results, performance or achievements to be materially different from any future results, performances or achievements expressed or implied by the forward-looking statements. Forward-looking statements may include, but are not limited to, statements about:
• the therapeutic potential of imetelstat and its expected uses and benefits;
• our plans to submit a New Drug Application, or NDA, and a marketing authorization application, or MAA, for imetelstat in Low or Intermediate-1 risk myelodysplastic syndromes, or lower risk MDS, and the anticipated timing thereof;
• the progress, timing, magnitude, scope and costs of clinical development, manufacturing and commercialization of imetelstat, including the number of indications which are or may in the future be pursued, subject to clearances and approvals by the U.S. Food and Drug Administration, or FDA, and other regulatory authorities;
• the continued enrollment in, and the continued conduct and completion of, IMpactMF, our Phase 3 clinical trial in relapsed/refractory myelofibrosis, or MF, IMproveMF, our Phase 1 combination clinical trial in frontline Intermediate-2 or High Risk MF, and IMpress, an investigator-led Phase 2 clinical trial in Intermediate-2 or High-Risk myelodysplastic syndromes and acute myeloid leukemia;
• the achievement and timing of clinical trial events related to IMpactMF, IMproveMF and IMpress, including the completion of patient enrollment and anticipated timing of data availability;
• other potential planned future clinical development plans for imetelstat;
• our plans to market and sell imetelstat, upon regulatory approval or clearance, in the U.S. and in Europe, whether alone or with new collaborative partners, and the anticipated timing thereof;
• our ability to obtain and maintain potential new collaborative arrangements to assist us in the development and potential commercialization of imetelstat, especially outside the U.S.;
• the availability of coverage and adequate third-party reimbursement for imetelstat, if any;
• our ability to consistently and reproducibly manufacture imetelstat;
• our ability to meaningfully reduce manufacturing costs of imetelstat;
• the impacts of the ongoing COVID-19 global pandemic, macroeconomic conditions, such as rising inflation rates, uncertain credit and global financial markets and supply chain disruptions, and geopolitical events, such as the conflict between Russia and Ukraine and related sanctions, on the foregoing;
• our ability to establish and maintain agreements with third-party service providers to support the development of imetelstat;
• the size and timing of expenditures and whether there are unanticipated expenditures;
• our ability to manage the anticipated growth of our business, including our ability to recruit and retain key personnel to support the development and potential future commercialization of imetelstat;
1
• our estimates and expectations regarding the sufficiency of our cash resources, our cash resource conservation efforts;
• our estimates regarding the extent of our ability to progress our imetelstat program with our existing capital resources;
• our ability to protect our intellectual property and the duration of any such protection, and operate our business without infringing upon the intellectual property rights of others;
• the implementation of our corporate strategy;
• our future financial and operating performance;
• our anticipated use of our existing capital resources; and
• our plans, objectives, expectations and intentions and any other statements that are not historical fact.
In some cases, you can identify forward-looking statements by terms such as “may,” “plan,” “intend,” “will,” “should,” “could,” “would,” “expects,” “plans,” “anticipates,” “believes,” “estimates,” “projects,” “predicts,” “potential” and similar expressions intended to identify forward-looking statements. These statements reflect our current views with respect to future events, are based on assumptions and are subject to risks an
Nov 3, 2022
2 gern-ex99_1.htm
Exhibit 99.1
Geron Corporation Reports Third Quarter 2022 Financial Results and Upcoming Expected Milestones
Top-Line Results from IMerge Phase 3 Trial in Lower Risk MDS Continue to be Expected in Early January 2023
Current and Projected Financial Resources Expected to Support Planned Milestones and Operations Through
Middle of 2024
Conference Call Scheduled for 9:00 a.m. ET Today
FOSTER CITY, Calif., November 3, 2022 -- Geron Corporation (Nasdaq: GERN), a late-stage clinical biopharmaceutical company developing a first-in-class telomerase inhibitor, imetelstat, to treat hematologic malignancies, today reported financial results for the third quarter of 2022 and upcoming expected milestones.
“Throughout the year, we have highlighted our vision for Geron to become a leader in the treatment of hematologic malignancies through the expected development and commercialization of imetelstat. We continue to believe that the differentiating qualities of imetelstat, including potential for disease modification and durability of effect, could transform the treatment landscape for lower risk myelodysplastic syndromes and JAK inhibitor relapsed/refractory myelofibrosis,” said John A. Scarlett, M.D., Geron’s Chairman and Chief Executive Officer. “We’re looking forward to the IMerge Phase 3 top-line results expected in just two months that if positive, will advance the company from late-stage development to commercialization and provide meaningful value for stockholders and patients.”
Upcoming Expected Milestones
2022
• Phase 2 and non-clinical updates expected at upcoming medical meeting
• Open remaining selected clinical sites in Phase 3 IMpactMF trial evaluating imetelstat vs. best available therapy in patients with JAK inhibitor relapsed/refractory myelofibrosis
• Start Phase 2 IMpress investigator-led study of single-agent imetelstat in relapsed/refractory (R/R) acute myeloid leukemia (AML) and higher risk MDS
2023
• Top-line results from IMerge Phase 3 in lower risk myelodysplastic syndromes (MDS) in early January
• New Drug Application submission in lower risk MDS in the U.S. in the first half of the year
• Marketing Authorization Application submission in lower risk MDS in the EU in the second half of the year
• Preliminary data from IMproveMF Phase 1 study of imetelstat in combination with ruxolitinib in frontline myelofibrosis by year-end
2024
• U.S. approval and commercial launch in lower risk MDS in the first half of the year
• IMpactMF interim analysis
Current and Projected Financial Resources
As of September 30, 2022, the Company had approximately $195 million in cash and marketable securities.
Under current planning assumptions, the Company projects its existing capital resources plus projected future proceeds of up to approximately $121 million from the potential exercise of the currently outstanding warrants and up to $50 million from the current debt facility will be sufficient to fund Geron’s estimated level of operations, which includes stage-gated activities for potential U.S. commercial launch of imetelstat in lower risk MDS, until the middle of 2024.
Third Quarter 2022 Results
For the third quarter of 2022, the Company reported a net loss of $41.1 million, or $0.10 per share, compared to $26.7 million, or $0.08 per share, for the comparable 2021 period. Net loss for the first nine months of 2022 was $99.3 million, or $0.26 per share, compared to $84.1 million, or $0.26 per share, for the comparable 2021 period.
Revenues for the three and nine months ended September 30, 2022, were $297,000 and $493,000, respectively, compared to $109,000 and $353,000 for the comparable 2021 periods. Revenues in both years primarily reflect estimated royalties from sales of cell-based research products from the Company’s divested stem cell assets.
Total operating expenses for the three and nine months ended September 30, 2022, were $40.2 million and $97.1 million, respectively, compared to $25.8 million and $83.4 million for the comparable 2021 periods.
Research and development expenses for the three and nine months ended September 30, 2022, were $24.6 million and $67.3 million, respectively, compared to $18.5 million and $61.6 million for the comparable 2021 periods. The increase in research and development expenses for the three and nine months ended September 30, 2022, compared to the same periods in 2021, primarily reflects the net result of increased personnel-related expenses for additional headcount and higher consulting costs related to preparation for top-line results and regulatory submissions in lower risk MDS; partially offset by decreased manufacturing costs due to the timing of imetelstat manufacturing batches.
General and administrative expenses for the three and nine months ended September 30, 2022, were $15.6 million and $29.8 million, respectively, compared to $7.3 million and $21.8 million for the comparable 2021 periods. The i
Aug 11, 2022
2 gern-ex99_1.htm
Press Release Dated, August 11, 2022
Geron Corporation Reports Second Quarter 2022 Financial Results
Top-Line Results from IMerge Phase 3 Trial in Lower Risk MDS Continue to be Expected in Early January 2023
Current and Projected Financial Resources Expected to Support Planned Milestones and Operations Through Middle of 2024
Conference Call Scheduled for 4:30 p.m. ET Today
FOSTER CITY, Calif., August 11, 2022 -- Geron Corporation (Nasdaq: GERN), a late-stage clinical biopharmaceutical company developing a first-in-class telomerase inhibitor, imetelstat, to treat hematologic malignancies, today reported financial results for the second quarter of 2022 and key upcoming expected milestones.
“We continue to focus intently on our plans for a catalyst-rich next two years, during which we expect to transform Geron from a development stage to commercial company,” said John A. Scarlett, M.D., Geron’s Chairman and Chief Executive Officer. “Our plan to disclose Phase 3 top-line results in lower risk MDS remains on track for early January 2023. Assuming positive top-line results, U.S. and EU regulatory submissions are also planned in the first and second half of 2023, respectively. In addition, we expect to continue the stage-gated buildout of our commercial capabilities and key talent across our organization to support a potential commercial U.S. launch of imetelstat in the first half of 2024.”
“In order to maintain a strong balance sheet, we also recently amended our existing loan facility to secure up to $50 million in additional non-dilutive capital, which we expect to be available in 2023,” Dr. Scarlett continued. “With these potential added debt proceeds, we believe our current and projected financial resources will be sufficient to fund our expected level of operations until the middle of 2024.”
Key Upcoming Expected Milestones
Lower Risk Myelodysplastic Syndromes (MDS)
• Top-line results from IMerge Phase 3 in early January 2023
• New Drug Application submission in the U.S. in the first half of 2023
• Marketing Authorization Application submission in the EU in the second half of 2023
• U.S. approval and commercial launch in the first half of 2024
Myelofibrosis
• Open remaining selected IMpactMF Phase 3 clinical sites by year-end 2022
• IMpactMF interim analysis in 2024
Pipeline expansion in additional indications and treatment combinations
• Start IMpress investigator-led study of single-agent imetelstat in relapsed/refractory (R/R) acute myeloid leukemia (AML) and higher risk MDS in the second half of 2022
• Start TELOMERE investigator-led Phase 1/2 study of imetelstat in combination with hypomethylating agents (HMAs) or venetoclax in R/R AML in the second half of 2022
• Initial preclinical lymphoid malignancies data by year-end 2022
• Preliminary data from IMproveMF Phase 1 study of imetelstat in combination with ruxolitinib in frontline myelofibrosis by year-end 2023
Additional Projected Financial Resources
In April 2022, the Company closed an underwritten public offering of common stock and warrants. The net cash proceeds from this offering were approximately $70 million, after deducting the underwriting discount and other offering expenses. The Company could receive up to $51.8 million in additional funding from the potential exercise of warrants from this offering, as well as up to $72.5 million from the potential exercise of warrants from an underwritten public offering that closed in May 2020.
In June 2022, the Company expanded its existing loan facility with Hercules Capital, Inc. and Silicon Valley Bank, from up to $75 million to up to $125 million. This amendment of the debt facility provides up to $50 million in additional non-dilutive capital, potentially available in 2023.
Of the aggregate $125 million loan facility, $50 million is currently outstanding. The remaining $75 million is potentially available to Geron in four tranches. The first tranche of $20 million is available until September 15, 2023, subject to the achievement of certain clinical and financial milestones. The second tranche of $10 million is available to the Company through December 15, 2023, subject to the achievement of certain clinical and regulatory milestones, and satisfaction of certain capitalization requirements. The third tranche of $20 million is available to the Company from September 15, 2023 until September 15, 2024, subject to the achievement of certain clinical and regulatory milestones, and satisfaction of certain capitalization requirements. The final tranche of $25 million is available to the Company through year-end 2024, subject to approval from the lenders.
Current and Projected Financial Resources
As of June 30, 2022, the Company had approximately $220 million in cash and marketable securities.
Under current planning assumptions, the Company projects its existing capital resources plus projected
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