Core Viewpoint - Geron Corporation is facing a class action lawsuit due to alleged misleading statements regarding its revenue outlook and the market potential of its drug Rytelo, leading to significant stock price decline after disappointing financial results were announced [3][4]. Group 1: Class Action Details - The class action lawsuit represents investors who purchased Geron securities between February 28, 2024, and February 25, 2025 [1]. - Investors are encouraged to contact the Portnoy Law Firm for a complimentary case evaluation and to discuss their legal rights [2]. Group 2: Allegations Against Geron - The lawsuit claims that Geron misrepresented its revenue projections and growth potential, downplaying risks related to seasonality and macroeconomic conditions [3]. - It is alleged that Geron's optimistic portrayal of Rytelo's launch was overstated, with actual market conditions affecting patient uptake more than indicated [3]. - The company failed to achieve significant market penetration for Rytelo, particularly among first-line patients, due to limited awareness and competitive pressures [3]. Group 3: Financial Impact - On February 26, 2025, Geron reported stagnant growth for Rytelo, attributing this to seasonality, competition, and monitoring burdens, which led to a stock price drop of over 32% [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 [2][4]. Group 1: Allegations and Financial Impact - The class period for the lawsuit is from February 28, 2024, to February 25, 2025, during which Geron allegedly provided investors with overly optimistic expectations about Rytelo's market potential while downplaying associated risks [2]. - On February 26, 2025, Geron reported that Rytelo's growth had flattened, attributing this to seasonality, competition, lack of awareness, and monitoring requirements, resulting in a stock price decline from $2.37 to $1.61, a drop of approximately 32.07% in one day [2]. Group 2: Next Steps for Shareholders - Shareholders who purchased shares during the specified class period are encouraged to register for the class action, with a deadline of May 12, 2025, to seek lead plaintiff status [3]. - Registered shareholders will receive updates through a portfolio monitoring software throughout the case lifecycle, with no cost or obligation to participate [3]. Group 3: Law Firm Background - The Gross Law Firm is a nationally recognized class action law firm dedicated to protecting investors' rights against deceit and illegal business practices, aiming to recover losses incurred due to misleading statements by companies [4].

Group 1 - The article highlights the expertise of an analyst with a background in nursing and business, focusing on healthcare and tech stocks through a combination of clinical insight and valuation methods [1] - The analyst employs scenario-based DCF modeling, sensitivity analysis, and Monte Carlo simulations to identify asymmetric risk-reward opportunities [1] - The emphasis is on translating complex scientific and market dynamics into actionable investment theses, influenced by concepts from "Superforecasting" and "Fooled by Randomness" [1] Group 2 - The article does not provide specific stock recommendations or personalized investment advice, indicating a probabilistic approach to analysis [3] - It emphasizes the importance of independent verification of information and conducting thorough research before making investment decisions [3]

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 aims to recover losses for Geron investors affected by the alleged fraud between February 28, 2024, and February 25, 2025 [1] - Defendants reportedly provided misleading information regarding the expectations for Rytelo, downplaying risks associated with its monitoring requirements and competition [2] - Following the announcement of flat growth for Rytelo on February 26, 2025, Geron'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 specified timeframe have until May 12, 2025, to request appointment as lead plaintiff [3] - Class members may be entitled to compensation without any out-of-pocket costs or fees [3] Group 3: Firm Background - Levi & Korsinsky 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 U.S. [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 aims to recover losses for Geron investors affected by the alleged fraud between February 28, 2024, and February 25, 2025 [1]. - Defendants reportedly provided misleading information regarding the expectations for Rytelo, downplaying risks associated with its monitoring requirements and competition [2]. - Following the announcement of Geron's fourth-quarter financial results for fiscal 2024, which revealed a flattening growth for Rytelo, the stock price plummeted 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 specified timeframe have until May 12, 2025, to request appointment as lead plaintiff, although participation does not require this role [3]. - Class members may be entitled to compensation without any out-of-pocket costs or fees [3]. Group 3: Firm Background - Levi & Korsinsky has a history of securing significant settlements for shareholders and is recognized as one of the top securities litigation firms in the U.S. [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 market conditions, including competition and the need for ongoing monitoring, which significantly impacted patient starts [3]. - The lawsuit further asserts that Geron failed to create sufficient market awareness for Rytelo, hindering its 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].

PART I. FINANCIAL INFORMATION [Item 1: Financial Statements (Unaudited)](index=4&type=section&id=Item%201%3A%20Financial%20Statements%20%28Unaudited%29) Unaudited condensed consolidated financial statements for Q1 2025, featuring **$39.4 million** in RYTELO net product revenue and a net loss of **$19.8 million** [Condensed Consolidated Balance Sheets](index=4&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) Presents key balance sheet figures for March 31, 2025, and December 31, 2024, detailing assets, liabilities, and equity Condensed Consolidated Balance Sheet Highlights (in thousands) | Account | March 31, 2025 | December 31, 2024 | | :--- | :--- | :--- | | **Assets** | | | | Cash, cash equivalents, and marketable securities | $455,672 | $501,085 | | Inventory | $56,222 | $38,714 | | Total current assets | $495,769 | $490,992 | | Total assets | $562,450 | $593,781 | | **Liabilities & Equity** | | | | Total current liabilities | $63,034 | $88,298 | | Noncurrent debt | $118,728 | $118,476 | | Noncurrent liability related to sale of future royalties | $110,381 | $104,421 | | Total stockholders' equity | $268,238 | $280,320 | [Condensed Consolidated Statements of Operations](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) Summarizes the company's financial performance for Q1 2025 and Q1 2024, detailing revenues, operating expenses, and net loss Statement of Operations Summary (in thousands, except per share data) | Metric | Q1 2025 | Q1 2024 | | :--- | :--- | :--- | | Product revenue, net | $39,436 | $0 | | Total revenues | $39,603 | $304 | | Total operating expenses | $56,307 | $56,438 | | Loss from operations | ($16,704) | ($56,134) | | Net loss | ($19,835) | ($55,390) | | Basic and diluted net loss per share | ($0.03) | ($0.09) | [Condensed Consolidated Statements of Cash Flows](index=9&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Outlines cash flows from operating, investing, and financing activities for the three months ended March 31 Cash Flow Summary for the Three Months Ended March 31 (in thousands) | Cash Flow Category | 2025 | 2024 | | :--- | :--- | :--- | | Net cash used in operating activities | ($47,979) | ($62,253) | | Net cash provided by investing activities | $52,439 | $34,207 | | Net cash provided by financing activities | $256 | $147,798 | | Net increase in cash, cash equivalents and restricted cash | $4,734 | $119,742 | [Notes to Condensed Consolidated Financial Statements](index=10&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) Provides detailed explanations and additional information supporting the condensed consolidated financial statements Q1 2025 Gross-to-Net Product Revenue Reconciliation (in thousands) | Description | Amount | | :--- | :--- | | Gross product revenue | $45,312 | | Chargebacks, and customer credits | ($5,697) | | Government rebates | ($66) | | Sales returns and allowances | ($113) | | **Net product revenue** | **$39,436** | - The company is facing two putative securities class action lawsuits and three shareholder derivative lawsuits filed in March and April 2025, alleging false and misleading statements concerning the commercial potential of RYTELO[73](index=73&type=chunk)[75](index=75&type=chunk)[76](index=76&type=chunk) - As of March 31, 2025, the company has noncancelable commercial purchase commitments for RYTELO manufacturing of approximately **$110.9 million**[80](index=80&type=chunk)[82](index=82&type=chunk) - The company entered into a **$250.0 million** senior secured term loan facility, drawing an initial **$125.0 million** in November 2024, and also entered into a royalty agreement, receiving an upfront payment of **$125.0 million** in exchange for future royalties on RYTELO sales[58](index=58&type=chunk)[65](index=65&type=chunk) [Item 2: Management's Discussion and Analysis of Financial Condition and Results of Operations](index=28&type=section&id=Item%202%3A%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses RYTELO's commercial launch, Q1 2025 net product revenue of **$39.4 million**, and liquidity, noting flat sales growth [Overview](index=28&type=section&id=Overview) Provides an overview of Geron's business, its key product RYTELO, and its commercialization strategy - Geron is a commercial-stage biopharmaceutical company focused on its first-in-class telomerase inhibitor, RYTELO (imetelstat)[108](index=108&type=chunk) - RYTELO was launched commercially in the U.S. in June 2024 for lower-risk MDS and received marketing authorization from the European Commission in March 2025[108](index=108&type=chunk) - The company is also conducting the Phase 3 IMpactMF clinical trial for imetelstat in relapsed/refractory myelofibrosis (MF), with an interim analysis for overall survival expected in the second half of 2026[110](index=110&type=chunk) - Weekly sales growth of RYTELO has been relatively flat since the end of Q4 2024, continuing into Q1 2025, resulting in lower net product revenue compared to Q4 2024, with the company's strategy focused on driving new patient starts[116](index=116&type=chunk)[117](index=117&type=chunk) [Results of Operations](index=30&type=section&id=Results%20of%20Operations) Analyzes the company's financial performance for Q1 2025 versus Q1 2024, detailing revenue, expenses, and net loss Q1 2025 vs Q1 2024 Results of Operations (in thousands) | Metric | Q1 2025 | Q1 2024 | Change (%) | | :--- | :--- | :--- | :--- | | Product revenues, net | $39,436 | $0 | 100% | | Research and development | $15,078 | $29,373 | (49)% | | Selling, general and administrative | $40,023 | $27,065 | 48% | | Loss from operations | ($16,704) | ($56,134) | (70)% | | Net loss | ($19,835) | ($55,390) | (64)% | - The decrease in R&D expenses was primarily due to lower clinical trial costs for the IMerge MDS study post-approval and the capitalization of manufacturing costs that were previously expensed[137](index=137&type=chunk) - The increase in SG&A expenses was mainly due to higher personnel-related costs from increased headcount to support the commercial launch of RYTELO[138](index=138&type=chunk) - Interest expense increased to **$8.2 million** from **$3.4 million**, primarily reflecting **$4.8 million** in non-cash interest related to the Royalty Pharma Agreement and **$3.3 million** related to the Pharmakon Loan Agreement[140](index=140&type=chunk) [Liquidity and Capital Resources](index=34&type=section&id=Liquidity%20and%20Capital%20Resources) Discusses the company's cash position, funding sufficiency, and material cash requirements including purchase commitments and debt - As of March 31, 2025, the company had cash, restricted cash, cash equivalents, and marketable securities of **$457.5 million**[143](index=143&type=chunk) - Management believes existing cash, combined with anticipated RYTELO revenues, will be sufficient to fund projected operating requirements for the foreseeable future[151](index=151&type=chunk) - Material cash requirements include approximately **$110.9 million** in manufacturing purchase commitments and debt service obligations under the Pharmakon Loan Agreement and Royalty Pharma Agreement[160](index=160&type=chunk)[162](index=162&type=chunk)[163](index=163&type=chunk) [Item 3: Quantitative and Qualitative Disclosures About Market Risk](index=39&type=section&id=Item%203%3A%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) No material changes occurred in the company's quantitative and qualitative market risk disclosures during Q1 2025 - There were no material changes to the company's market risk disclosures during the three months ended March 31, 2025[168](index=168&type=chunk) [Item 4: Controls and Procedures](index=39&type=section&id=Item%204%3A%20Controls%20and%20Procedures) Management concluded that disclosure controls and procedures were effective as of March 31, 2025, with no material changes to internal controls - Management concluded that as of the end of the period, the company's disclosure controls and procedures were effective at a reasonable assurance level[168](index=168&type=chunk) - No changes in internal control over financial reporting occurred during the quarter that materially affected, or are reasonably likely to materially affect, internal controls[169](index=169&type=chunk) PART II. OTHER INFORMATION [Item 1: Legal Proceedings](index=40&type=section&id=Item%201%3A%20Legal%20Proceedings) This section refers to Note 7 for details on ongoing legal proceedings, including securities class action and derivative lawsuits - The company refers to Note 7 of the financial statements for information on legal proceedings, which details recent securities class action and derivative lawsuits[172](index=172&type=chunk) [Item 1A: Risk Factors](index=40&type=section&id=Item%201A%3A%20Risk%20Factors) This section outlines material risks, including RYTELO's commercial dependence, flat sales growth, regulatory hurdles, manufacturing reliance, and ongoing litigation - The company's near-term prospects are wholly dependent on RYTELO, and its ability to generate meaningful revenue is at risk if it cannot successfully commercialize the product in the U.S. for lower-risk MDS or expand its indications[186](index=186&type=chunk) - Weekly sales growth of RYTELO has been relatively flat since the end of Q4 2024, and the company's strategy to drive new patient starts may not achieve meaningful sales growth[188](index=188&type=chunk) - The company and certain current and former officers are defendants in securities class action and derivative lawsuits, which could result in substantial damages and divert management's attention[183](index=183&type=chunk)[375](index=375&type=chunk) - The company has a history of net losses, with an accumulated deficit of approximately **$1.8 billion** as of March 31, 2025, and may not achieve consistent future profitability[298](index=298&type=chunk) [Item 2: Unregistered Sales of Equity Securities, Use of Proceeds, and Issuer Purchases of Equity Securities](index=93&type=section&id=Item%202%3A%20Unregistered%20Sales%20of%20Equity%20Securities%2C%20Use%20of%20Proceeds%2C%20and%20Issuer%20Purchases%20of%20Equity%20Securities) The company reported no unregistered sales of equity securities, use of proceeds, or issuer purchases during the period - None reported[432](index=432&type=chunk) [Item 5: Other Information](index=93&type=section&id=Item%205%3A%20Other%20Information) This section discloses the adoption and termination of Rule 10b5-1 trading plans by company directors and officers - During the quarter, former CEO John A. Scarlett terminated a Rule 10b5-1 trading plan on February 27, 2025, and Director Susan Molineaux, Ph.D. adopted a new Rule 10b5-1 trading plan on March 14, 2025[435](index=435&type=chunk)[436](index=436&type=chunk) [Item 6: Exhibits](index=95&type=section&id=Item%206%3A%20Exhibits) This section lists exhibits filed with the Quarterly Report on Form 10-Q, including compensation policies and certifications - Exhibits filed include the Non-Employee Director Compensation Policy, an offer letter for Interim CEO Dawn C. Bir, and certifications from the CEO and CFO[437](index=437&type=chunk)

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), which led to a significant decline in stock price after disappointing financial results were announced [3][4]. Group 1: Allegations and Financial Impact - The class action is based on claims that Geron provided investors with overly optimistic expectations about Rytelo's launch and market potential, while downplaying risks related to monitoring requirements and competition [3]. - Following the announcement of fourth-quarter fiscal 2024 results, Geron reported that Rytelo's growth had flattened, attributing this to seasonality, competition, and lack of awareness, resulting in a stock price drop from $2.37 to $1.61, a decline of approximately 32.07% in one day [3]. Group 2: Class Action Details - The class period for the lawsuit is defined as February 28, 2024, to February 25, 2025, with a deadline for shareholders to register for participation set for May 12, 2025 [4]. - Shareholders who register will receive updates on the case's progress and can seek lead plaintiff status without any cost or obligation [4]. Group 3: Law Firm Background - The Gross Law Firm, which is leading the class action, is recognized for its commitment to protecting investors' rights against deceit and fraud, aiming to hold companies accountable for misleading practices [5].

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]