Company Overview - Geron Corp. is a single-product biotech company that launched an infusion drug, Imetelstat, in June 2024 for the treatment of myelodysplastic syndrome (MDS) [1] - The company is also developing Imetelstat for a second cancer indication, myelofibrosis [1] Leadership and Expertise - The executive has over 10 years of experience in the biotechnology and healthcare industry, along with 15 years of biomedical research experience [1] - The executive has served as Investment Director at a major VC&PE fund in Russia, focusing on life sciences, and has been on the Board of Directors for several biotech startups in the US and Russia [1] - The executive's background includes academic appointments at the University of Pittsburgh and Russian State Medical University, with over 50 peer-reviewed publications [1] Product Development and Strategy - The company emphasizes a systematic analysis approach to estimate risks, clinical values, and commercial prospects of innovative projects [1] - The goal is to improve patients' lives by designing new medicines and translating ideas into commercially viable products [1]

Core Viewpoint - Bragar Eagel & Squire, P.C. is investigating potential claims against Geron Corporation due to a class action complaint alleging breaches of fiduciary duties by the board of directors during a specified class period [1][2]. Group 1: Legal Investigation - A class action complaint was filed against Geron Corporation on March 14, 2025, with a class period from February 28, 2024, to February 25, 2025 [1]. - The investigation focuses on whether Geron's board of directors failed to fulfill their fiduciary responsibilities to the company [1]. Group 2: Allegations in the Complaint - The complaint alleges that Geron's executives provided misleading information regarding the launch and growth potential of Rytelo (imetelstat) [2]. - It is claimed that the executives expressed confidence in addressing the unmet need for Rytelo while downplaying risks related to monitoring requirements and competition [2].

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].