[Executive Summary and Business Highlights](index=1&type=section&id=Executive%20Summary%20and%20Business%20Highlights) Geron reported strong Q2 2025 results, highlighted by **$49.0 million** in RYTELO® net product revenue, near-complete IMpactMF Phase 3 enrollment, and strategic commercial and leadership expansions Q2 2025 Key Achievements | Metric | Value/Status | | :--- | :--- | | RYTELO® Net Product Revenue | $49.0 million | | IMpactMF Phase 3 Enrollment | Over 95% complete | | New Leadership | Harout Semerjian appointed as President and CEO | - The company increased its commercial sales team by **20%** and doubled its medical science liaisons to enhance awareness and adoption of RYTELO[2](index=2&type=chunk) [RYTELO Commercial Performance](index=1&type=section&id=RYTELO%20Commercial%20Performance) RYTELO's Q2 2025 net product revenue grew **24%** QoQ to **$49.0 million**, driven by a **17%** demand increase and an expanded customer base RYTELO Q2 2025 Commercial Metrics | Metric | Value | Change (QoQ) | | :--- | :--- | :--- | | Net Product Revenue | $49.0 million | +24% | | Demand | - | +17% | | Ordering Accounts | >1,000 | +400 YTD | - Geron is actively preparing for the anticipated launch of RYTELO in select EU countries following its approval earlier in the year[4](index=4&type=chunk) [IMpactMF Phase 3 Clinical Trial Update](index=1&type=section&id=IMpactMF%20Phase%203%20Clinical%20Trial%20Update) The IMpactMF Phase 3 trial is over **95%** enrolled, targeting full enrollment by year-end 2025, with overall survival data readouts in H2 2026 (interim) and H2 2028 (final) - The IMpactMF trial is over **95%** enrolled as of July 2025, with full enrollment expected by the end of 2025[4](index=4&type=chunk) IMpactMF Trial Analysis Timeline | Analysis Type | Expected Timing | | :--- | :--- | | Interim Analysis (Overall Survival) | H2 2026 | | Final Analysis (Overall Survival) | H2 2028 | [Second Quarter 2025 Financial Results](index=2&type=section&id=Second%20Quarter%202025%20Financial%20Results) Geron reported **$49.0 million** in Q2 2025 total net revenue, significantly narrowing its net loss to **$16.4 million** and ending the quarter with **$432.6 million** in cash Q2 2025 vs Q2 2024 Financial Summary | Metric | Q2 2025 | Q2 2024 | | :--- | :--- | :--- | | Total Net Revenue | $49.0 million | $0.9 million | | Net Loss | ($16.4 million) | ($67.4 million) | | Net Loss Per Share | ($0.02) | ($0.10) | | Total Operating Expenses | $61.5 million | $70.2 million | - As of June 30, 2025, Geron had approximately **$432.6 million** in cash, cash equivalents, restricted cash, and marketable securities[5](index=5&type=chunk) [Revenues](index=2&type=section&id=Revenues) Total net revenue for Q2 2025 reached **$49.0 million**, primarily from RYTELO product sales, a substantial increase from **$0.9 million** in Q2 2024 post-FDA approval Revenue Breakdown (Three Months Ended June 30) | Revenue Source | 2025 | 2024 | | :--- | :--- | :--- | | Product revenue, net | $49.0 million | $780,000 | | Total net revenue | $49.0 million | $882,000 | [Operating Expenses](index=2&type=section&id=Operating%20Expenses) Total operating expenses decreased to **$61.5 million** in Q2 2025, primarily due to reduced R&D costs post-RYTELO approval and capitalized manufacturing expenses Operating Expenses Breakdown (Three Months Ended June 30) | Expense Category | 2025 | 2024 | | :--- | :--- | :--- | | Cost of goods sold | $1.2 million | $17,000 | | Research and development | $21.7 million | $30.8 million | | Selling, general and administrative | $38.6 million | $39.4 million | | **Total operating expenses** | **$61.5 million** | **$70.2 million** | - The decrease in R&D expenses was mainly due to reduced clinical trial costs for the IMerge study after RYTELO's FDA approval and the capitalization of manufacturing costs[10](index=10&type=chunk) [2025 Financial Guidance](index=2&type=section&id=2025%20Financial%20Guidance) Geron reaffirmed its 2025 operating expense guidance of **$270 million to $285 million**, confident existing cash and RYTELO revenues will fund future operations - The company maintains its fiscal year 2025 guidance for total operating expenses to be between approximately **$270 million** and **$285 million**[12](index=12&type=chunk) - Management believes that current cash, marketable securities, and expected RYTELO revenues are sufficient to fund projected operating requirements for the foreseeable future[13](index=13&type=chunk) [Product and Pipeline Overview](index=3&type=section&id=Product%20and%20Pipeline%20Overview) Geron's RYTELO (imetelstat), a first-in-class telomerase inhibitor, is approved in the U.S. and EU for LR-MDS, while imetelstat progresses in the IMpactMF Phase 3 trial for MF [About RYTELO (imetelstat)](index=3&type=section&id=About%20RYTELO%20(imetelstat)) RYTELO, the first and only approved telomerase inhibitor, is approved in the U.S. and EU for adult LR-MDS patients with transfusion-dependent anemia, targeting those ineligible for or unresponsive to ESAs - RYTELO is a first-in-class oligonucleotide telomerase inhibitor that works by inhibiting telomerase enzymatic activity, which is key to the uncontrolled division of abnormal bone marrow cells in LR-MDS[17](index=17&type=chunk) - The drug is approved in the U.S. for adult patients with LR-MDS with transfusion-dependent anemia requiring at least four red blood cell units over eight weeks who have failed or are ineligible for ESAs[15](index=15&type=chunk) - The EU approval is for a similar patient population but specifically for those without an isolated deletion 5q cytogenetic abnormality[16](index=16&type=chunk) [About IMpactMF Phase 3](index=3&type=section&id=About%20IMpactMF%20Phase%203) The IMpactMF trial is a registrational Phase 3 study evaluating imetelstat against best available therapy in approximately **320** relapsed/refractory MF patients, with overall survival as its primary endpoint - The trial targets a patient population of approximately **320** individuals with intermediate-2 or high-risk myelofibrosis who have relapsed after or are refractory to JAK inhibitor treatment[19](index=19&type=chunk) - The primary endpoint is overall survival (OS), with key secondary endpoints including symptom response, spleen response, and progression-free survival[19](index=19&type=chunk) [Financial Statements](index=6&type=section&id=Financial%20Statements) Geron's Q2 2025 financial statements show **$49.0 million** in product revenue, a **$16.4 million** net loss, **$555.2 million** in total assets, and **$259.5 million** in stockholders' equity [Condensed Consolidated Statements of Operations](index=6&type=section&id=CONDENSED%20CONSOLIDATED%20STATEMENTS%20OF%20OPERATIONS) For Q2 2025, Geron reported **$49.0 million** in net product revenue, a narrowed loss from operations of **$12.5 million**, and a net loss of **$16.4 million**, or **$0.02** per share Condensed Consolidated Statements of Operations (Unaudited, In thousands, except per share data) | | Three Months Ended, June 30 | Six Months Ended, June 30 | | :--- | :--- | :--- | | | **2025** | **2024** | **2025** | **2024** | | **Product revenue, net** | **$49,007** | **$780** | **$88,443** | **$780** | | Total revenues | $49,036 | $882 | $88,639 | $1,186 | | Total operating expenses | $61,490 | $70,215 | $117,797 | $126,653 | | Loss from operations | ($12,454) | ($69,333) | ($29,158) | ($125,467) | | **Net loss** | **($16,375)** | **($67,383)** | **($36,210)** | **($122,773)** | | **Net loss per share** | **($0.02)** | **($0.10)** | **($0.05)** | **($0.19)** | [Condensed Consolidated Balance Sheets](index=7&type=section&id=CONDENSED%20CONSOLIDATED%20BALANCE%20SHEETS) As of June 30, 2025, Geron's balance sheet reported **$555.2 million** in total assets, **$295.7 million** in total liabilities, and **$259.5 million** in stockholders' equity Condensed Consolidated Balance Sheets (Unaudited, In thousands) | | June 30, 2025 | December 31, 2024 | | :--- | :--- | :--- | | **Assets** | | | | Cash, cash equivalents and restricted cash | $79,604 | $80,876 | | Marketable securities (Current & Noncurrent) | $352,990 | $422,069 | | **Total Assets** | **$555,198** | **$593,781** | | **Liabilities and Equity** | | | | Total Liabilities | $295,667 | $313,461 | | **Stockholders' equity** | **$259,531** | **$280,320** | | **Total Liabilities and Stockholders' Equity** | **$555,198** | **$593,781** | [Forward-Looking Statements](index=3&type=section&id=Use%20of%20Forward-Looking%20Statements) This section addresses forward-looking statements concerning RYTELO's commercial potential, trial timelines, and financial projections, emphasizing inherent risks that could cause actual results to differ materially - Forward-looking statements include expectations regarding RYTELO's commercial trajectory, the timing of its EU launch, and the progress and data readouts for the IMpactMF trial[21](index=21&type=chunk)[22](index=22&type=chunk) - The company's projections for 2025 operating expenses and its belief in having sufficient capital to fund operations are also considered forward-looking[22](index=22&type=chunk) - Key risks that could cause actual results to differ include challenges in commercialization, regulatory delays or denials, adverse clinical trial results, and manufacturing or supply chain issues[22](index=22&type=chunk)

Commercial Performance & Strategy - RYTELO's U S commercial success is the company's top priority[10, 45] - The estimated 2025 U S RYTELO total addressable LR-MDS patient population is approximately 15,400[16] - Approximately 85% of covered lives are under plans with favorable RYTELO coverage policies[27] - Since approval, approximately 900 accounts have placed orders, with approximately 300 new accounts since January 2025[26] - Approximately 25% of RYTELO new patient starts are in the 1st and 2nd line settings[26] - The company plans to commercialize RYTELO in select EU4 countries starting in 2026, pending strong reimbursement and favorable pricing[29] Clinical Development - The IMpactMF Phase 3 trial is 85% enrolled, with interim analysis anticipated in the second half of 2026[36, 38, 47] Financial Update - As of March 31, 2025, the company's cash and marketable securities were approximately $457 5 million[43] - Q1 2025 net product revenue was $39 4 million[43] - Total net product revenue since launch (June 2024) is $115 9 million[43] - The company expects total operating expenses for 2025 to range from $270 million to $285 million[43]

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].