Revenue Potential and Financial Performance - RYTELO (imetelstat) has the potential to achieve over $1B in net revenue, targeting eligible lower-risk myelodysplastic syndromes (LR-MDS) patients[2] - Q3 2024 net revenues were reported at $28.2M, with estimated Q4 2024 net revenues projected between $45M and $46M[4] - The company expects to reach profitability without additional financing if current internal revenue and operating expense expectations are met[4] - Cash and marketable securities as of December 31, 2024, are approximately $500 million[42] - The expected operating expenses for 2024 are projected to be between $250 million and $260 million[42] - The company anticipates reaching profitability without additional financing[40] Clinical Development and Trial Results - The Phase 3 trial in JAKi relapsed/refractory myelofibrosis (MF) is 75% enrolled, which could potentially double the commercial opportunity for RYTELO if results are positive[4] - The Phase 3 IMpactMF trial is designed to confirm the overall survival signal observed in the Phase 2 study, with interim analysis expected in early 2026 and final analysis in early 2027[32][34] - The primary endpoint of the Phase 3 trial is overall survival, with secondary endpoints including total symptom score and spleen volume reduction[36] - Imetelstat 9.4 mg/kg is currently being actively enrolled for dose confirmation, with no dose-limiting toxicities reported in the first 28 days of Cycle 1[98] - The study aims to confirm the safety of doses and evaluate efficacy, with initial results from Part 2 expected in 2026[98] Treatment Efficacy and Patient Population - The treatment-eligible population for RYTELO in 2025 is estimated to be around 15,400 patients, with potential revenue generation from treating only one-third of these patients[16] - The estimated treatment-eligible population for RYTELO in the U.S. includes approximately 3,400 first-line patients and 16,800 second-line patients[16] - Durable red blood cell transfusion independence rates for Imetelstat are 39.8% for ≥ 8-week RBC-TI and 28.0% for ≥ 24-week RBC-TI[62] - Approximately 60% of imetelstat-treated patients achieved red blood cell transfusion independence for at least 8 weeks[69] - In the overall population, 39.8% of imetelstat patients achieved RBC transfusion independence compared to 15.0% in the placebo group, a difference of 24.8%[73] - Clinical benefits have been observed in lower-risk myelodysplastic syndromes (LR-MDS) and MF patients treated with Imetelstat, showcasing a unique mechanism of action[100] Regulatory and Market Position - The U.S. commercial launch of RYTELO is off to a strong start, with approximately 80% payor coverage as of the end of Q4 2024[19] - RYTELO is positioned as a Category 1 treatment in NCCN guidelines for second-line therapy in both ring sideroblast positive and negative patients[12] - The company anticipates a favorable impact on clinical decision-making due to RYTELO's inclusion in the NCCN Guidelines as a treatment for symptomatic anemia in LR-MDS patients[2] - RYTELO is positioned as a highly differentiated treatment for lower-risk myelodysplastic syndromes (LR-MDS), with exclusivity expected in the U.S. until 2037 and in the EU until 2038[49][50] - The expected EU approval for RYTELO in LR-MDS is anticipated in the first half of 2025[47] Safety and Adverse Events - The safety profile of imetelstat included hematologic adverse events, with thrombocytopenia occurring in 75% of patients and neutropenia in 74%[86] - 74% of patients treated with imetelstat experienced dose modifications, primarily due to grade 3-4 neutropenia and thrombocytopenia[91] - No cases of Hy's Law or drug-induced liver injury were observed in patients treated with imetelstat[91] Additional Observations and Mechanisms - Imetelstat demonstrated a median hemoglobin rise of 3.6 g/dL in patients with a transfusion reduction of ≥4 units over 8 weeks[67] - The median time to first sustained improvement in the FACIT-Fatigue score was 65.0 weeks for imetelstat compared to 28.3 weeks for placebo[79] - Imetelstat showed consistent responses across MDS subgroups, with the highest response rate of 45.2% in RS+ patients[73] - There is an association between survival improvement and reduction in VAF for high-risk relapsed/refractory (HR R/R) MF patients treated with Imetelstat[102] - Disappearance of bone marrow fibrosis has been noted in HR MF patients treated with Imetelstat[103] - The pharmacokinetic profiles of Imetelstat are consistent with previous monotherapy studies, supporting its ongoing development[99]

Group 1 - Geron Corporation (NASDAQ: GERN) has received US marketing approval for Rytelo (imetelstat) aimed at treating lower-risk myelodysplastic syndromes (LR-MDS) in mid-2024 [1] - The company has been actively marketing Rytelo for several quarters following the approval [1] - An analyst rated GERN as a hold in April 2024, indicating a cautious outlook on the stock following the approval [1]

Core Insights - The article discusses the Biotech Analysis Central service, which provides in-depth analysis of pharmaceutical companies and investment opportunities in the biotech sector [1][2]. Group 1 - The service offers a library of over 600 biotech investing articles, a model portfolio of more than 10 small and mid-cap stocks, and live chat features for investors [2]. - A promotional offer is available for new subscribers, including a two-week free trial and a discounted annual subscription price of $399, which represents a 33.50% discount compared to the monthly rate [1]. - The author emphasizes that the analysis provided is independent and not influenced by any business relationships with the companies mentioned [3].

Core Viewpoint - Geron Corporation experienced a transformational year in 2024 with the FDA approval and commercial launch of Rytelo (imetelstat) for treating low- to intermediate-1 risk myelodysplastic syndromes (MDS) with transfusion-dependent anemia, leading to a significant increase in its stock price [1][3]. Company Performance - Geron's shares increased by 61.1% over the past year, contrasting with a 15.6% decline in the industry [1]. - Rytelo generated sales of $28.2 million in its first full quarter post-launch, surpassing company expectations due to high unmet needs in lower-risk MDS [3]. - Loss estimates for Geron improved from 26 cents per share to 25 cents for 2024, and from 10 cents to 6 cents for 2025 over the past 60 days [8]. Regulatory Developments - The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) recommended Rytelo's approval in the EU, with a decision from the European Commission expected in the first half of 2025 [4]. Research and Development - Geron is conducting a phase III IMpactMF study for Rytelo in patients with relapsed/refractory myelofibrosis (MF), with early findings from the IMproveMF study indicating potential tolerability of imetelstat and ruxolitinib as a combination therapy for MF [5]. Financial Position - Geron secured $375 million in funding through synthetic royalty and debt financing, enhancing its cash position to support the commercial launch of Rytelo in the U.S. and potential EU launch, as well as ongoing studies in MF [6].

Performance and Growth - Geron (NASDAQ: GERN) has significantly outperformed expectations in the first full quarter of launch, with substantial investor interest driving financial inflows [1] - The company's performance metrics show remarkable growth percentages, including 1212%, 1200%, and 1000%, indicating a strong upward trajectory [2][4] Investor Tools and Resources - The Total Pharma Tracker service provides a comprehensive set of tools for DIY investors, including a software feature that allows users to enter any ticker and access extensive curated research material [2][3] - In-house experts offer hands-on support by utilizing these tools to identify the best investible stocks, complete with buy/sell strategies and alerts [3] Historical Performance - Historical data from 2017 to 2023 shows a cumulative performance with notable fluctuations, including a -6% in 2018 and a -19% in 2022, but overall positive growth trends [2][4]

Financial Performance - Total revenues for the nine months ended September 30, 2024, were $29,457,000, compared to $214,000 for the same period in 2023, representing a significant increase[6] - Product revenue for the nine months ended September 30, 2024, was $28,989,000, with royalties contributing $468,000[6] - The net loss for the nine months ended September 30, 2024, was $149,220,000, compared to a net loss of $132,154,000 for the same period in 2023[6] - Basic and diluted net loss per share for the nine months ended September 30, 2024, was $(0.23), consistent with the same period in 2023[6] - Comprehensive loss for the nine months ended September 30, 2024, was $148,387,000, compared to $132,885,000 for the same period in 2023, indicating an increase in losses[8] Assets and Liabilities - Total current assets increased to $398,057,000 as of September 30, 2024, up from $341,348,000 at the end of 2023, reflecting a growth of approximately 16.6%[4] - Total current liabilities rose to $137,933,000 as of September 30, 2024, compared to $108,070,000 at the end of 2023, indicating an increase of about 27.6%[4] - Cash and cash equivalents decreased to $60,344,000 as of September 30, 2024, from $70,023,000 at the end of 2023, a decline of approximately 9.5%[4] - The total stockholders' equity increased to $292,284,000 as of September 30, 2024, up from $247,949,000 at the end of 2023, representing a growth of about 17.8%[4] Expenses - Research and development expenses for the nine months ended September 30, 2024, totaled $80,305,000, down from $92,135,000 in the prior year, a decrease of approximately 12.9%[6] - Selling, general, and administrative expenses for the nine months ended September 30, 2024, were $102,361,000, compared to $47,734,000 for the same period in 2023, reflecting an increase of about 114.5%[6] - Stock-based compensation for employees and directors increased to $24,392 from $14,110, representing an increase of approximately 72.5%[12] Cash Flow - Net cash used in operating activities for the nine months ended September 30, 2024, was $174,673, compared to $126,805 for the same period in 2023, indicating a significant increase of approximately 37.7%[12] - Cash, cash equivalents, and restricted cash at the end of the period were $62,198, up from $31,245 at the end of the previous period, reflecting an increase of approximately 99.5%[12] - The company reported a net cash used in investing activities of $2,493 for the nine months ended September 30, 2024, compared to $227,891 in the previous period, reflecting a significant decrease of approximately 98.9%[12] Stock and Equity - As of March 31, 2024, Geron Corporation had 591,163,808 common shares outstanding, reflecting an increase from 508,731,846 shares as of March 31, 2023[10] - The total additional paid-in capital as of June 30, 2024, was $2,027,173,000, up from $1,799,841,000 as of June 30, 2023[10] - The company issued 41,999,998 shares of common stock in connection with the exercise of warrants, raising $141,000,000[9] Inventory and Product Revenue - Inventory decreased by $20,283 during the nine months ended September 30, 2024, with no prior period data available for comparison[12] - The company began capitalizing inventory related to RYTELO in the quarter ended June 30, 2024, following its approval on June 6, 2024[20] - As of September 30, 2024, net product revenue from U.S. sales of RYTELO was $28,209,000, with gross product revenue of $32,657,000, resulting in total gross-to-net adjustments of $4,448,000[57] Debt and Financing - The outstanding principal amount under the Hercules Loan Agreement was $80.0 million as of September 30, 2024, with a net carrying value of $83.8 million, which includes accrued end of term charges[77] - The interest rate on the Hercules Loan Agreement was set at 12.5% as of September 30, 2024, with an interest-only period extended through December 31, 2024[76] - Future minimum payments under the Hercules Loan Agreement total $92.50 million, with $2.55 million due in the remainder of 2024 and $89.95 million in 2025[79] Legal and Compliance - The company has not established any reserve for potential liabilities related to future lawsuits, which could materially impact its financial statements[80] - Geron Corporation is currently not involved in any material pending legal proceedings, which may help in focusing resources on business activities[80] Marketable Securities - The company has not recorded any allowances for credit losses on available-for-sale securities for the three and nine months ended September 30, 2024, indicating no unrealized losses attributable to credit factors[64] - The fair value of marketable securities as of September 30, 2024, was $316,742,000, with gross unrealized losses of $1,010,000[60] Agreements and Commitments - As of September 30, 2024, Geron has noncancelable commercial purchase commitments totaling approximately $62.4 million related to contract manufacturing agreements for RYTELO[84] - Geron entered into a revenue participation right purchase agreement with Royalty Pharma, receiving an upfront payment of $125.0 million in exchange for tiered revenue interest payments on RYTELO sales[97]

Group 1 - The biotech forum has seen significant discussions around profitable buy-write or covered call strategies on selected biotech stocks over the past few months [1] - Geron Corporation (NASDAQ: GERN) has experienced a busy and potentially transformative 18 months, marking a significant period for the company [2] - The investing group, The Biotech Forum, offers a model portfolio featuring 12-20 high upside biotech stocks, along with live chat for trade ideas and weekly market commentary [2] Group 2 - The analyst has a beneficial long position in Geron Corporation shares through stock ownership, options, or other derivatives [3]

Financial Data and Key Metrics Changes - Geron Corporation reported $28.2 million in net product revenue from RYTELO for Q3 2024, significantly higher than the $164,000 reported in Q3 2023, indicating a strong commercial launch performance [35] - Total net revenue for Q3 2024 was $28.3 million, compared to $214,000 for the same period in 2023, reflecting the successful introduction of RYTELO [35] - Total operating expenses for Q3 2024 were $56.5 million, up from $47.8 million in Q3 2023, primarily due to increased commercial launch expenses [36] Business Line Data and Key Metrics Changes - RYTELO's initial quarter of product revenue demonstrates the company's effective execution as a commercial entity, with demand coming from 388 ordering centers, representing about 45% of targeted accounts [21] - The company achieved a strong IP position with FDA's orphan drug exclusivity for lower-risk MDS until June 2031, providing exclusivity in the U.S. through August 2037 [9] Market Data and Key Metrics Changes - In the U.S., payers covering approximately 70% of covered lives have implemented medical coverage policies for RYTELO consistent with its FDA label [23] - The company anticipates the CHMP review of RYTELO's marketing authorization application in Europe could be completed by late 2024 or early 2025, with potential EU approval in the first half of 2025 [11] Company Strategy and Development Direction - The primary focus is on maximizing RYTELO's market opportunity in the U.S. and preparing for its potential launch in select EU markets starting in 2026 [10][30] - The company aims to optimize patient access and revenues for imetelstat in prioritized EU countries, leveraging experienced third parties for market access and distribution [30] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the long-term commercial value of RYTELO, emphasizing the high unmet need in lower-risk MDS and the product's compelling value proposition [8] - The company is optimistic about the trajectory of RYTELO's sales and expects continued demand and growth momentum into 2025 [28] Other Important Information - Geron completed a synthetic royalty transaction and a debt financing transaction, generating $250 million in gross proceeds, which will provide critical flexibility for growth and investment [13][14] - The company expects total operating expenses for fiscal year 2024 to be in the range of approximately $260 million to $270 million [39] Q&A Session Summary Question: Growth cadence expectations for RYTELO - Management expects steady consistent growth across all patient segments, particularly in second-line treatments, but is not providing specific guidance at this time [67] Question: Clarification on royalty percentage rates - The royalty agreement is competitive, with a cap at 1.65x the initial payment, and management is confident in reaching this cap based on internal revenue projections [70][72] Question: Utilization split between academic and community prescribers - The current split is approximately 65% community prescribers and 35% academic, with expectations for continued growth in both segments [91] Question: Initial real-world experience with RYTELO - Early feedback indicates that real-world performance aligns with clinical trial data, and physicians are comfortable managing cytopenias associated with RYTELO [86][88] Question: Plans for expanding sales in the U.S. - The additional capital will support U.S. commercialization efforts and preparation for a potential EU launch, while maintaining a cash buffer of over 12 months [100]

Geron (GERN) came out with a quarterly loss of $0.04 per share versus the Zacks Consensus Estimate of a loss of $0.09. This compares to loss of $0.08 per share a year ago. These figures are adjusted for non-recurring items.This quarterly report represents an earnings surprise of 55.56%. A quarter ago, it was expected that this drugmaker would post a loss of $0.11 per share when it actually produced a loss of $0.10, delivering a surprise of 9.09%.Over the last four quarters, the company has surpassed consens ...

Core Insights - Royalty Pharma has acquired a synthetic royalty on U.S. sales of Geron Corporation's RYTELO for $125 million, enhancing its synthetic royalty funding to $925 million in 2024, indicating a significant opportunity in this funding modality [1][4] Group 1: Product Approval and Market Potential - RYTELO (imetelstat) received FDA approval in June 2024 for treating low- to intermediate-1 risk myelodysplastic syndromes (LR-MDS) with transfusion-dependent anemia [2] - The National Comprehensive Cancer Network (NCCN) has updated its guidelines to include imetelstat as a Category 1 and 2A treatment for symptomatic anemia in LR-MDS patients [2] - Geron is currently enrolling patients in a Phase 3 trial of imetelstat for myelofibrosis patients who are relapsed/refractory to JAK-inhibitors, indicating ongoing development in hematologic malignancies [2][3] Group 2: Financial Terms and Implications - Royalty Pharma will receive tiered royalty payments on U.S. net sales of RYTELO, starting at 7.75% for annual net sales up to $500 million, decreasing to 3.0% for sales between $500 million and $1 billion, and further to 1.0% for sales exceeding $1 billion [4] - Payments to Royalty Pharma will cease if the aggregate royalties through June 30, 2031, reach 1.65 times its investment, otherwise, payments will continue until a multiple of 2.0 times its investment is achieved [4] Group 3: Strategic Partnerships and Future Outlook - The partnership with Royalty Pharma is expected to strengthen Geron's cash position and balance sheet, providing flexibility for future investments [4] - Royalty Pharma's CEO expressed optimism about the commercial and development opportunities for RYTELO, highlighting its importance for the lower-risk MDS patient population [3]