Company Performance - Geron reported a quarterly loss of $0.03 per share, better than the Zacks Consensus Estimate of a loss of $0.04, and an improvement from a loss of $0.09 per share a year ago, representing an earnings surprise of 25% [1] - The company posted revenues of $39.6 million for the quarter ended March 2025, missing the Zacks Consensus Estimate by 18.75%, compared to revenues of $0.3 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 three times as well [2] Stock Performance - Geron shares have declined approximately 62.7% since the beginning of the year, while the S&P 500 has only declined by 4.7% [3] - The current Zacks Rank for Geron is 4 (Sell), indicating that the shares are expected to underperform the market in the near future [6] Future Outlook - The current consensus EPS estimate for the upcoming quarter is -$0.03 on revenues of $52.86 million, and for the current fiscal year, it is -$0.13 on revenues of $219.57 million [7] - The outlook for the Medical - Biomedical and Genetics industry is relatively strong, with the industry currently in the top 35% of over 250 Zacks industries, suggesting that stocks in the top 50% outperform those in the bottom 50% by more than 2 to 1 [8]

Financial Data and Key Metrics Changes - As of March 31, 2025, the company had approximately $457.5 million in cash and equivalents, down from $502.9 million as of December 31, 2024 [42] - Total net product revenue for Q1 2025 was $39.4 million, a decrease of $8 million from Q4 2024, attributed to inventory drawdown among distributors [7][42] - Research and development expenses for Q1 2025 were $15.1 million, significantly lower than $29.4 million for the same period in 2024, due to reduced clinical trial costs [43] - Selling, general, and administrative expenses increased to $40 million in Q1 2025 from $27.1 million in the same period last year, primarily due to higher personnel expenses [44] Business Line Data and Key Metrics Changes - Q1 sales of Rytello were $39.4 million, with demand relatively flat at a 1% increase compared to the previous thirteen weeks [7] - Approximately 900 sites of care have utilized Rytello, an increase of nearly 300 new sites since the end of Q4 2024 [24] - Demand grew approximately 10% in the four-week period ending April 25, 2025, compared to the prior four-week period, marking the highest month-over-month growth since October 2024 [25] Market Data and Key Metrics Changes - The estimated U.S. total addressable market for Rytello is approximately 15,400 lower-risk MDS patients, with significant opportunities to expand use in earlier lines of treatment [15] - In Europe, the total addressable market for Rytello is estimated to be about 80% of the U.S. market [15] - Approximately 85% of U.S. covered lives are now under favorable Rytello medical coverage policies consistent with FDA labels and NCCN guidelines [26] Company Strategy and Development Direction - The primary corporate priority is the successful U.S. commercialization of Rytello, with a focus on increasing brand awareness and refining marketing efforts [6][10] - The company plans to work with experienced third parties for commercialization outside the U.S. to minimize investment while focusing on U.S. efforts [11] - The late-stage clinical development program aims to expand Imetel for broader use within hematology, potentially doubling the commercial opportunity of Rytello if successful [12][48] Management's Comments on Operating Environment and Future Outlook - Management acknowledged that Q1 sales were modest and do not reflect Rytello's true commercial potential, emphasizing the commitment to making it part of the standard of care for eligible patients [46] - The company is encouraged by early performance indicators and is prepared to make adjustments to improve commercial execution [47] - The pivotal Phase III trial evaluating Imetelstat in relapsed-refractory myelofibrosis is expected to provide interim analysis data in the second half of 2026, which could significantly impact commercial potential [48] Other Important Information - The process to identify a permanent CEO is ongoing, with a decision expected within the next six months [12] - The company is expanding its medical affairs team to enhance community awareness and HCP confidence in prescribing Rytello [29] Q&A Session Summary Question: Expectations for Q2 and year cadence - Management noted that inventory issues are behind them, and they anticipate continued momentum building into Q2 and throughout 2025 [50][53] Question: Commercial efforts to promote switching to Rytello - Management highlighted that awareness and education are key to driving physician perceptions and utilization of Rytello, with positive shifts noted in recent market research [56][60] Question: Inventory dynamics and corrections - Management explained that higher inventory levels were due to several factors, including seasonality and anticipation of pricing issues, but they believe the situation has stabilized [64][66] Question: Reasons for physicians not reordering Rytello - Management indicated that discontinuations are largely reflective of clinical trial data, with no new surprises in market research [87] Question: Demand increase sustainability - Management expressed optimism about sustaining the recent 10% demand increase, attributing it to effective messaging and physician engagement [97]

Financial Data and Key Metrics Changes - As of March 31, 2025, the company had approximately $457.5 million in cash, cash equivalents, restricted cash, and marketable securities, down from $502.9 million as of December 31, 2024 [43] - Total net product revenue for Q1 2025 was $39.4 million, a decrease of $8 million from Q4 2024, attributed to an inventory drawdown among distributors [43][44] - Research and development expenses for Q1 2025 were $15.1 million, compared to $29.4 million for the same period in 2024, primarily due to lower clinical trial costs [44][45] - Selling, general, and administrative expenses increased to $40 million in Q1 2025 from $27.1 million in the same period last year, mainly due to higher personnel expenses [45] Business Line Data and Key Metrics Changes - Q1 Rytello net revenues were $39.4 million, down from Q4, with demand relatively flat at a 1% increase compared to the previous thirteen weeks [6][44] - Approximately 900 sites of care utilized Rytello as of April 2025, an increase of almost 300 new sites since the end of Q4 [24] - Demand grew approximately 10% in the four-week period ending April 25 compared to the prior four-week period, marking the highest month-over-month growth since October 2024 [25] Market Data and Key Metrics Changes - The estimated U.S. total addressable market for Rytello is approximately 15,400 lower-risk MDS patients, with significant opportunities to expand use in earlier lines of treatment [15] - In Europe, the estimated total addressable market for Rytello is approximately 80% of the U.S. market [15] - Approximately 85% of U.S. covered lives are now under favorable Rytello medical coverage policies consistent with FDA label and NCCN guidelines [26] Company Strategy and Development Direction - The company's top priority is the successful commercialization of Rytello in the U.S., with plans to increase brand awareness and refine marketing efforts [5][17] - The company is pursuing a disciplined path for EU commercialization, planning to engage third-party partners to minimize investment while focusing on U.S. efforts [11][28] - The ongoing Phase III trial for Imetelstat in relapsed-refractory myelofibrosis could potentially double the commercial opportunity for Rytello if successful [12][48] Management's Comments on Operating Environment and Future Outlook - Management acknowledged that Q1 sales were modest and do not reflect the product's true commercial potential, emphasizing the commitment to making Rytello part of the standard of care [47] - The company is encouraged by early performance indicators and is ready to make adjustments to improve commercial execution [47] - The interim analysis for the Phase III trial is expected in the second half of 2026, with management optimistic about the potential outcomes [49] Other Important Information - The company is in the process of identifying a permanent CEO, with a decision expected within the next six months [12] - The company plans to maintain financial discipline while investing in the commercialization strategy for Rytello [46] Q&A Session Summary Question: What are the expectations for Q2 given the inventory impacts and demand improvements? - Management noted that inventory issues have been addressed and expects continued momentum into Q2, with new commercial representatives expected to impact later in the year [50][53] Question: Can you comment on commercial efforts to promote switching to Rytello? - Management highlighted that awareness and education are key, with positive shifts in perceptions regarding Rytello's efficacy and cytopenia management among physicians [56][58] Question: What is the current status of inventory levels? - The inventory at the end of Q1 was on the lower end of two to two and a half weeks, indicating a drawdown from the higher levels seen previously [93] Question: Are new patient starts exceeding discontinuations? - Management indicated that while there is no perfect data, new patient starts are promising, with approximately 25% of new starts occurring in the first and second lines of therapy [96] Question: What drove the incremental cash burn in Q1? - The cash burn was higher due to payouts of bonuses and early investments in inventory, typical for Q1 [97]

Financial Performance - Geron Corporation reported $39.4 million in net product revenue from RYTELO® (imetelstat) in Q1 2025, with demand relatively flat compared to previous periods[1][4][7]. - Total net revenue for Q1 2025 was $39.6 million, a significant increase from $0.3 million in the same period in 2024[1][8]. - Geron reported a net loss of $19.8 million, or $0.03 per share, for Q1 2025, an improvement from a net loss of $55.4 million, or $0.09 per share, in Q1 2024[1][6]. - Basic and diluted net loss per share for Q1 2025 was $0.03, compared to $0.09 in Q1 2024[38]. Operating Expenses - Total operating expenses for Q1 2025 were $56.3 million, slightly down from $56.4 million in the same period in 2024[1][9]. - Research and development expenses decreased to $15.1 million in Q1 2025 from $29.4 million in Q1 2024, primarily due to reduced clinical trial costs[1][10]. - Selling, general and administrative expenses increased to $40.0 million in Q1 2025 from $27.1 million in Q1 2024, reflecting higher personnel costs for commercialization efforts[1][11]. - Geron maintains its 2025 financial guidance for total operating expenses in the range of $270 million to $285 million[1][14]. - The company projects total operating expenses for fiscal year 2025 to be managed effectively to reach profitability without additional financing[35]. Cash and Assets - As of March 31, 2025, Geron had approximately $457.5 million in cash and marketable securities, down from $502.9 million at the end of 2024[1][5]. - Current assets increased to $495.769 million as of March 31, 2025, from $490.992 million at the end of 2024[40]. - Cash, cash equivalents, and restricted cash rose to $85.610 million from $80.876 million at the end of 2024[40]. - Current liabilities decreased to $63.034 million from $88.298 million at the end of 2024[40]. Clinical Trials and Product Launch - Approximately 85% enrollment has been reached in the Phase 3 IMpactMF clinical trial, with an interim analysis expected in the second half of 2026[1][4]. - The company received marketing authorization for RYTELO from the European Commission, planning to launch in select EU countries in 2026[1][4]. - The company expects to commercialize RYTELO in select EU countries in 2026[35]. - The company anticipates that U.S. sales of RYTELO will be sufficient to fund projected operating requirements for the foreseeable future[35].

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 Geron's reports on Rytelo's launch success were overly optimistic, failing to account for significant market challenges such as competition and the need for ongoing monitoring of treatment [3]. - The lawsuit also states 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].

Core Viewpoint - Geron Corporation is facing a class action securities lawsuit due to alleged securities fraud related to the launch and growth potential of its drug Rytelo (imetelstat) [1][2] Group 1: Lawsuit Details - The lawsuit seeks to recover losses for Geron investors affected by alleged fraud between February 28, 2024, and February 25, 2025 [1] - Defendants allegedly provided misleading information regarding the expectations for Rytelo's market performance, downplaying risks associated with the drug's monitoring requirements and competition [2] - Following the announcement of Geron's fourth-quarter financial results for fiscal 2024, which revealed stagnant growth for Rytelo, the company's stock price dropped from $2.37 to $1.61, a decline of approximately 32.07% in one day [2] Group 2: Next Steps for Investors - Investors who suffered losses during the relevant timeframe have until May 12, 2025, to request appointment as lead plaintiff, although participation in any recovery does not require this [3] - Class members may be entitled to compensation without any out-of-pocket costs or fees [3] Group 3: Firm Background - Levi & Korsinsky, LLP has a strong track record in securities litigation, having secured hundreds of millions for shareholders over the past 20 years [4] - The firm has been recognized in ISS Securities Class Action Services' Top 50 Report for seven consecutive years as a leading securities litigation firm in the United States [4]

Core Viewpoint - Geron Corporation is facing a class action securities lawsuit due to alleged securities fraud related to the launch and growth potential of its drug Rytelo (imetelstat) between February 28, 2024, and February 25, 2025 [1][2]. Group 1: Lawsuit Details - The lawsuit claims that Geron's management provided misleading information regarding the drug's market potential and downplayed risks associated with its monitoring requirements and competition [2]. - Following the announcement of Geron's fourth-quarter financial results for fiscal 2024 on February 26, 2025, which revealed a flattening growth for Rytelo, the company's stock price dropped significantly from $2.37 to $1.61, a decline of approximately 32.07% in one day [2]. Group 2: Investor Information - Investors who suffered losses during the specified period have until May 12, 2025, to request appointment as lead plaintiff, although participation in any recovery does not require this role [3]. - Class members may be entitled to compensation without any out-of-pocket costs or fees, indicating a no-cost participation in the lawsuit [3]. Group 3: Firm Background - Levi & Korsinsky, LLP has a strong track record in securities litigation, having secured hundreds of millions for shareholders over the past 20 years and consistently ranking among the top securities litigation firms in the United States [4].

Core Viewpoint - Geron Corporation is facing a class action lawsuit due to allegations of misleading statements regarding the growth potential of its drug Rytelo (imetelstat), leading to a significant drop in stock price after disappointing financial results were announced [1][2]. Summary by Sections Allegations - The complaint alleges that Geron provided investors with overly optimistic expectations about Rytelo's launch and growth potential, while downplaying risks related to monitoring requirements, seasonality, and competition [1]. - Following the announcement of fourth-quarter financial results for fiscal 2024, which revealed that Rytelo's growth had flattened, Geron's stock price fell from $2.37 to $1.61, a decline of approximately 32.07% in one day [1]. Class Action Details - The class period for the lawsuit is defined as February 28, 2024, to February 25, 2025, and shareholders are encouraged to register for participation [2]. - The deadline for shareholders to seek lead plaintiff status is May 12, 2025, and there is no cost to participate in the case [2]. Law Firm Information - The Gross Law Firm is a nationally recognized class action law firm dedicated to protecting investors' rights against deceit and illegal business practices [3]. - The firm aims to ensure companies adhere to responsible business practices and seeks recovery for investors who suffered losses due to misleading statements [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].