Core Insights - A class action has been filed against Geron Corporation on behalf of investors who acquired its securities between June 7, 2024, and February 25, 2025, due to alleged misleading information regarding the launch and growth potential of its product Rytelo [1][2]. Company Overview - Geron Corporation is a commercial-stage biopharmaceutical company focused on blood cancer treatment, with its primary product being a telomerase inhibitor named imetelstat, marketed as Rytelo [1]. Allegations - The complaint claims that Geron misled investors by presenting overly optimistic reports about Rytelo's launch success and growth potential, failing to disclose significant factors such as seasonality, competition, and the burden of monitoring that affected patient starts [2]. - It is alleged that Rytelo lacked sufficient market awareness, hindering Geron's ability to meet the significant unmet need for the drug, especially among first-line patients and those outside academic settings [2]. Financial Impact - On February 26, 2025, Geron announced its fourth-quarter financial results for fiscal 2024, revealing that Rytelo's growth had stagnated. The company attributed this to seasonality, competition, lack of awareness, and monitoring requirements [3]. - Following this announcement, Geron's stock price plummeted from $2.37 per share on February 25, 2025, to $1.61 per share on February 26, 2025, marking a decline of approximately 32.07% in one day [3].

Core Viewpoint - Geron Corporation is facing a class action lawsuit for alleged violations of the Securities Exchange Act of 1934, with claims that the company and its executives misled investors regarding the performance and market potential of its primary product, Rytelo [1][3]. Group 1: Class Action Details - The class action lawsuit, titled Dabestani v. Geron Corporation, allows purchasers of Geron securities from June 7, 2024, to February 25, 2025, to seek appointment as lead plaintiff by May 12, 2025 [1][5]. - The lawsuit alleges that Geron made false statements about its revenue outlook and growth potential, downplaying risks associated with seasonality and competition [3][4]. - Geron's primary product, Rytelo, is a telomerase inhibitor, which has reportedly struggled to gain market awareness and penetration, impacting its sales performance [2][3]. Group 2: Financial Impact - On February 26, 2025, Geron reported that Rytelo's growth had flattened, attributing this to seasonality, competition, and lack of market awareness, leading to a stock price decline of over 32% [4]. - The lawsuit claims that the optimistic projections made by Geron were not reflective of the actual market conditions and challenges faced by the product [3][4]. Group 3: Legal Representation - Robbins Geller Rudman & Dowd LLP is representing investors in this class action lawsuit, noted for its significant recoveries in securities fraud cases, including over $2.5 billion in 2024 alone [6]. - The firm has a strong track record in securities class action recoveries, having secured the largest recovery in history at $7.2 billion in the Enron case [6].

NEW YORK, Feb. 27, 2025 (GLOBE NEWSWIRE) -- The law firm of Kirby McInerney LLP is investigating potential claims against Geron Corporation ("Geron" or the "Company") (NASDAQ:GERN). The investigation concerns whether Geron and/or certain of its officers have violated the federal securities laws and/or engaged in other unlawful business practices. [LEARN MORE ABOUT THE INVESTIGATION] On February 26, 2025, Geron announced its financial results for the fourth year and full year 2024. During a related earnings ...

NEW YORK, Feb. 26, 2025 /PRNewswire/ -- Pomerantz LLP is investigating claims on behalf of investors of  Geron Corporation ("Geron" or the "Company") (NASDAQ: GERN). Such investors are advised to contact Danielle Peyton at [email protected] or 646-581-9980, ext. 7980.The investigation concerns whether Geron and certain of its officers and/or directors have engaged in securities fraud or other unlawful business practices. [Click here for information about joining the class action] On February 26, 2025, Geron ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the Fiscal Year Ended December 31, 2024 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to . Commission File Number: 000-20859 GERON CORPORATION (Exact name of registrant as specified in its charter) Delaware (State or other jurisdiction of incorporat ...

Core Insights - The analysis emphasizes a conservative investment strategy, allocating 90% to stable investments and 10% to growth opportunities for balanced returns [1] - A detailed valuation framework is presented, projecting free cash flows over a 9-year period with a focus on consistent annual growth rates and discounting cash flows using CAPM [1] - The pharmaceutical revenue model outlines market adoption starting at 12.5% and reaching 100% by peak sales, with a significant decline in penetration post-exclusivity [1] Valuation Framework - The base valuation framework projects free cash flows over a 9-year period, starting from a baseline year, applying consistent annual growth rates [1] - Cash flows are discounted using a rate calculated through CAPM, considering both time value and risk factors [1] - Terminal value is calculated by projecting Year 9 cash flows and applying a sustainable long-term growth rate, assuming steady growth patterns [1] Pharmaceutical Revenue Model - The model assumes market adoption begins at 12.5% penetration at launch, growing linearly to 100% by the peak sales year [1] - Post-exclusivity, penetration drops sharply by 80% in the first year and declines by 5% annually thereafter [1] - Revenue is calculated by multiplying the number of patients by the annual treatment cost, with costs scaling proportionally with revenue [1]

Geron Corporation (NASDAQ:GERN) Q4 2024 Earnings Conference Call February 26, 2025 8:00 AM ET Company Participants Aron Feingold - VP of IR and Corporate Communications John Scarlett - Chairman and CEO Michelle Robertson - EVP and CFO Jim Ziegler - EVP and CCO Joseph Eid - EVP, R&D Faye Feller - EVP and CMO Conference Call Participants Peter Lawson - Barclays Tara Bancroft - TD Cowen Faisal Khurshid - Leerink Partners Greg Harrison - Scotiabank Stephen Willey - Stifel Emily Bodnar - H.C. Wainwright Kalpit P ...

Q4 and Full Year 2024 Earnings Call February 26, 2025 Welcome and Introduction JOHN SCARLETT, M.D. Chairman of the Board, President and Chief Executive Officer MICHELLE ROBERTSON Executive Vice President, Chief Financial Officer and Treasurer JIM ZIEGLER Executive Vice President, Chief Commercial Officer JOSEPH EID, M.D. Executive Vice President, Research and Development FAYE FELLER, M.D. Executive Vice President, Chief Medical Officer 2 Forward-Looking Statements During the course of this presentation and ...

Company Performance - Geron reported a quarterly loss of $0.04 per share, which was worse than the Zacks Consensus Estimate of a loss of $0.02, representing an earnings surprise of -100% [1] - The company posted revenues of $47.54 million for the quarter ended December 2024, exceeding the Zacks Consensus Estimate by 4.67%, compared to revenues of $0.02 million in the same quarter last year [2] - Over the last four quarters, Geron has surpassed consensus EPS estimates three times and topped consensus revenue estimates four times [2] Stock Movement and Outlook - Geron shares have declined approximately 33.1% since the beginning of the year, while the S&P 500 has gained 1.3% [3] - The company's earnings outlook is mixed, with the current consensus EPS estimate for the coming quarter at -$0.04 on revenues of $57.3 million, and -$0.07 on revenues of $297.85 million for the current fiscal year [7] Industry Context - The Medical - Biomedical and Genetics industry, to which Geron belongs, is currently ranked in the top 24% of over 250 Zacks industries, indicating a favorable outlook compared to the bottom 50% [8] - Empirical research shows a strong correlation between near-term stock movements and trends in earnings estimate revisions, which can impact Geron's stock performance [5]

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]