Summary of Geron (NasdaqGS: GERN) FY Conference Call - December 02, 2025 Company Overview - **Company**: Geron Corporation - **Product**: Rytello (imetelstat), a first-in-class telomerase inhibitor targeting low-risk myelodysplastic syndromes (MDS) patients - **Sales Performance**: Reported $47.2 million in net sales in the U.S. for the last quarter, marking five quarters since launch [3][4][32] Key Points and Arguments Product Efficacy and Market Position - Rytello has demonstrated strong efficacy in clinical trials, particularly in durability and transfusion independence [4][10] - Despite strong clinical data, commercial uptake has been modest compared to expectations, especially when compared to competitors like Luspatercept, which generates over $2 billion annually [4][5] - The company aims to improve uptake by focusing on operational excellence and ensuring the right patients are prescribed Rytello [5][6] Market Strategy and Growth Potential - The company plans to target earlier lines of therapy to drive growth in 2026, moving from later-line patients to second-line patients as indicated by the IMerge study [7][9] - The NCCN guidelines have been updated to position Rytello favorably in relation to other therapies, enhancing its market potential [10] - The company has seen an increase in new accounts, with 1,150 accounts now ordering Rytello, up by 150 from the previous quarter [17] Challenges and Solutions - A significant challenge is the lack of awareness among U.S. physicians regarding Rytello, as most pivotal trial enrollments were conducted outside the U.S. [8][9] - The company is working to build relationships with key opinion leaders (KOLs) and ensure effective communication of trial data [11][12] - Engagement with academic medical centers (AMCs) is crucial, as these institutions are more likely to conduct their own experiments and publish results [21][22] Financial Management and Operational Efficiency - Geron has reduced its operational expenditure (OpEx) guidance for the year to between $250 million and $260 million, emphasizing the need for disciplined spending [32][33] - The company is focused on targeted investments rather than broad spending, aiming to maximize the impact of its resources [33][34] Future Outlook - The IMpactMF trial for myelofibrosis is fully enrolled, with interim analysis expected in H2 2026 and full analysis in H2 2028 [31] - The trial design aims to demonstrate that Rytello can transform myelofibrosis from a deadly disease to a manageable one, potentially doubling the addressable patient market [29][31] Additional Important Insights - The company is addressing concerns regarding cytopenia associated with Rytello, emphasizing the importance of managing this side effect to maintain patient adherence to therapy [25][26] - The focus on tailored messaging for different physician groups is critical for successful commercialization, particularly in the community setting [23][24] This summary encapsulates the key discussions and insights from the Geron FY Conference Call, highlighting the company's strategic direction, challenges, and future growth potential in the oncology market.

Summary of Geron Corporation Conference Call Company Overview - **Company**: Geron Corporation - **Core Asset**: Imetelstat (commercial name: Rytelo), the first approved telomerase inhibitor for lower-risk myelodysplastic syndromes (MDS) [2][5] Key Points Company and Product Positioning - Geron is a commercial-stage hematology company with an approved product, Rytelo, launched in the US and approved in Europe [2][5] - The company aims to help patients in the relapse, lower-risk MDS population, which has limited treatment options [2][5] Leadership and Experience - Harout Semerjian, the new CEO, has over 30 years of experience in biopharma, particularly in oncology and hematology [4][5] - The CEO's previous experience includes launching multiple oncology drugs, which aligns with Geron's current needs [4][5] Market Performance and Challenges - Rytelo's growth has stalled, with net revenue around $50 million, despite strong phase 3 data [6][9] - The disconnect between the drug's efficacy and sales performance is attributed to: - Initial patient selection being primarily late-line patients, who are harder to treat [8][9] - Limited clinical experience among US hematologists at launch, as most trial data was generated outside the US [9][10] Strategic Initiatives - The company is focusing on increasing awareness and education among physicians about Rytelo's efficacy and appropriate patient management [12][13] - Efforts are being made to shift Rytelo's utilization from later lines of treatment to earlier lines, as indicated by clinical guidelines [12][21] Patient Population and Treatment Dynamics - The real-world patient population primarily consists of third-line and fourth-line patients, which affects treatment duration and outcomes [17][18] - The NCCN guidelines have recently been updated to position Rytelo favorably in treatment protocols, moving it ahead of other therapies like HMAs [18][19][21] Competitive Landscape - Luspatercept's approval as a front-line therapy for RS-positive patients may impact patient flow into later lines of treatment, creating opportunities for Rytelo as a second-line option [30][31] - Physicians' treatment decisions are influenced by baseline transfusion burden, with Rytelo being the only effective option for heavily transfused patients [37][38] Future Outlook - Geron anticipates growth in 2026, supported by a robust cash balance and strategic initiatives aimed at enhancing market presence [11][40][41] - The company has submitted five abstracts for the upcoming ASH conference, including data on cytopenia correlating with response and long-term survival benefits [41][42] International Expansion - Geron is exploring commercialization plans in Europe, including launching under named patient programs and engaging in HTA conversations [50][51] Additional Insights - The company is committed to educating the market about Rytelo's unique mechanism of action and the importance of managing cytopenias effectively [40][41] - There is a focus on building partnerships with both community and academic medical centers to enhance Rytelo's adoption [27][28]

Group 1: Geron Corporation (GERN) - A shareholder class action lawsuit has been filed against Geron Corporation, alleging that the company disseminated materially false and/or misleading statements and concealed material adverse facts regarding Rytelo's (imetelstat) potential between February 28, 2024, and February 25, 2025 [1] - Investors who purchased Geron shares during this period and suffered significant losses are encouraged to discuss their legal rights [1] Group 2: Fluence Energy, Inc. (FLNC) - A shareholder class action lawsuit has been filed against Fluence Energy, Inc., alleging that the company made materially false and/or misleading statements and failed to disclose material facts regarding its relationship with founders Siemens AG and The AES Corporation between October 28, 2021, and February 10, 2025 [2] - Investors who purchased Fluence shares during this period and suffered significant losses are encouraged to discuss their legal rights [2] Group 3: Holzer & Holzer, LLC - Holzer & Holzer, LLC is a top-rated securities litigation law firm that focuses on representing shareholders and investors in litigation, including shareholder class action and derivative litigation [3] - Since its founding in 2000, the firm has played critical roles in recovering hundreds of millions of dollars for shareholders affected by fraud and corporate misconduct [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]. Company Overview - Geron Corporation is a commercial-stage biopharmaceutical company focused on developing therapeutic products for oncology, with its main product being a telomerase inhibitor called imetelstat, marketed as Rytelo [2]. Allegations of the Lawsuit - The lawsuit alleges that Geron and its executives made false or misleading statements about the company's revenue outlook and growth potential, downplaying risks associated with seasonality and macroeconomic factors [3]. - It is claimed that the optimistic reports regarding Rytelo's launch success did not reflect the reality of market conditions, including competition and the need for ongoing monitoring of the treatment [3]. - The lawsuit further asserts that Rytelo lacked sufficient market awareness, hindering Geron's ability to meet the significant unmet need for the drug, particularly among first-line patients [3]. Financial Impact - Following the announcement of Geron's fourth-quarter financial results for fiscal year 2024 on February 26, 2025, which indicated a flattening growth for Rytelo, the company's stock price dropped by over 32% [4].

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]. Company Overview - Geron Corporation is a commercial-stage biopharmaceutical company focused on developing therapeutic products for oncology, with its main product being a telomerase inhibitor called imetelstat, marketed as Rytelo [2]. Allegations of the Lawsuit - The lawsuit alleges that Geron and its executives made false or misleading statements about the company's revenue outlook and growth potential, downplaying risks associated with seasonality and macroeconomic factors [3]. - It is claimed that the optimistic reports regarding Rytelo's launch success did not reflect the reality of its market penetration challenges, including competition and a lack of awareness among potential patients [3]. - Following the announcement of financial results for Q4 2024, which indicated stagnant growth for Rytelo, Geron's stock price dropped over 32%, highlighting the impact of the alleged misrepresentations [4]. Legal Process - Investors who purchased Geron securities during the specified class period can seek to be appointed as lead plaintiff in the class action lawsuit, representing the interests of all class members [5]. Law Firm Background - Robbins Geller Rudman & Dowd LLP is a leading law firm specializing in securities fraud and shareholder litigation, having secured over $2.5 billion for investors in 2024 alone [6].

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]. Company Overview - Geron Corporation is a commercial-stage biopharmaceutical company focused on developing therapeutic products for oncology, with its main product being a telomerase inhibitor called imetelstat, marketed as Rytelo [2]. Allegations of the Lawsuit - The lawsuit alleges that Geron and its executives made false or misleading statements about the company's revenue outlook and growth potential, downplaying risks associated with seasonality and macroeconomic factors [3]. - It is claimed that the reported success of Rytelo's launch was overstated, as actual market conditions, including competition and the need for ongoing monitoring, significantly impacted patient adoption [3]. - The lawsuit further contends that Rytelo lacked sufficient market awareness, hindering Geron's ability to meet the unmet medical needs, particularly among first-line patients [3]. Financial Impact - Following the announcement of its fourth-quarter financial results for fiscal year 2024 on February 26, 2025, which revealed stagnant growth for Rytelo, Geron's stock price dropped by over 32% [4].