Core Insights - Geron Corporation has announced significant executive transitions to align its leadership with strategic priorities, including the appointment of Ahmed ElNawawi as the new Chief Commercial Officer [1][2][3] Leadership Changes - Andrew Grethlein, the current Chief Operating Officer, will transition to a consulting role effective October 15, 2025, after serving since January 2019 [1] - Jim Ziegler, the current Chief Commercial Officer, will also depart on October 15, 2025, to pursue other interests [1] - Ahmed ElNawawi will take over as Chief Commercial Officer on October 20, 2025, focusing on driving growth and maximizing the potential of RYTELO [1][2] New Executive Appointments - Three additional executives have been appointed: - Shanthakumar Tyavanagimatt as Senior Vice President, Chief Technical Officer, bringing over 25 years of experience in drug development and technical operations [2][5] - Dawn Schottlandt as Senior Vice President, Investor Relations and Corporate Affairs, with over 20 years in investor relations within the life sciences industry [2][8] - Bryan Ridgell as Senior Vice President, Portfolio and Project Management and Chief of Staff, with extensive experience in program and portfolio management [2][8] Strategic Focus - The new leadership team is expected to enhance Geron's capabilities in commercial, operational, and development areas, particularly in expanding the reach and impact of RYTELO [3][4] - ElNawawi aims to deepen engagement and deliver operational excellence across the business, building on the existing foundation [4] Company Overview - Geron Corporation is a commercial-stage biopharmaceutical company focused on changing the course of blood cancer, with its first-in-class telomerase inhibitor RYTELO approved for certain adult patients with lower-risk myelodysplastic syndromes [6]

Core Insights - The biotech investment strategy focuses on a balanced portfolio with 85% in commercial stage and 15% in clinical stage companies, emphasizing disciplined position sizing and quality over quantity [5][6][8] - The community aspect of biotech investing is highlighted, where collaboration and feedback among members enhance investment decisions and strategies [9][10][15] - The current market environment presents opportunities in rare diseases and companies nearing growth stages, with a focus on those with approved drugs and clear paths to profitability [21][24][27] Group 1 - The ROTY Biotech Community has grown to nearly 500 members, including analysts and medical professionals, contributing to a collaborative investment environment [5][9] - The investment approach includes strict position sizing rules, with a maximum of 10% in commercial stage companies and 5% in clinical stage companies [6][20] - The strategy emphasizes long-term perspectives, focusing on sales projections for 2025 and beyond, and the importance of clinical momentum [8][21] Group 2 - Recent successes in the biotech sector, such as uniQure's advancements in gene therapy, have attracted more generalist investors to the space [16][18] - The investment community encourages a disciplined approach to trading, with a focus on maintaining a trade log to analyze performance and improve strategies [22][30] - The importance of understanding regulatory risks is emphasized, as even promising drugs can face unexpected challenges during the approval process [44][49] Group 3 - Syndax Pharmaceuticals is highlighted as a top holding, with a significant gain since entry, driven by positive developments in their lead drug [32][33] - Geron Corporation is presented as a potential investment opportunity, with a focus on its approved drug for blood cancer and a favorable enterprise value [49][52] - The current market dynamics suggest that while some biotech stocks are being overlooked, there are attractive opportunities in commercial stage companies [38][47]

Core Insights - The biotech investment strategy focuses on a mix of commercial stage (85%) and clinical stage (15%) companies, emphasizing disciplined position sizing and a long-term perspective on sales growth and clinical momentum [5][8][21]. Investment Strategy - The investment approach is characterized by strict position sizing rules, with a maximum of 10% in any commercial stage company and 5% in clinical stage companies [6]. - The strategy involves trading infrequently, typically two to four times a month, to avoid overtrading and to focus on quality investments [7][8]. - The community aspect of the ROTY Biotech Community allows for collaborative idea sharing and constructive criticism, enhancing investment decisions [9][10][15]. Market Trends - Recent successes in gene therapy and rare diseases are attracting more generalist investors to the biotech sector, creating a "halo effect" that could lead to increased investment [17][21]. - The FDA's favorable regulatory environment for rare diseases is seen as a significant tailwind for biotech investments [21][41]. Company Examples - Syndax Pharmaceuticals (SNDX) has shown a 60% gain since entry, driven by the approval of their lead drug and positive market reception [32][33]. - Geron Corporation (GERN) is highlighted as a potential investment opportunity due to its novel drug for blood cancer, which is currently undervalued relative to its peak sales potential [49][51]. Risk Management - Investors are advised to maintain a trade log to analyze performance and replicate successful strategies while avoiding past mistakes [22]. - The importance of understanding personal risk tolerance is emphasized, particularly in a volatile sector like biotech [30][31].

Equity Awards - Geron Corporation granted equity awards covering an aggregate of 966,000 shares of common stock, including stock options for 644,000 shares and restricted stock units (RSUs) for 322,000 shares to sixteen newly hired employees [1][2] - The stock options have an exercise price of $1.27 per share, equal to the closing price on the grant date, with a ten-year term and vesting over four years [2] - RSUs vest at a rate of 25% on each anniversary of the grant date, contingent on continued employment [2] Company Overview - Geron is a commercial-stage biopharmaceutical company focused on treating blood cancer, with its first-in-class telomerase inhibitor RYTELO® (imetelstat) approved in the US and EU for certain adult patients with lower-risk myelodysplastic syndromes [3] - The company is conducting a pivotal Phase 3 clinical trial of imetelstat for JAK-inhibitor relapsed/refractory myelofibrosis and other myeloid hematologic malignancies [3] - The mechanism of action involves inhibiting telomerase activity to reduce proliferation and induce death of malignant cells in the bone marrow [3]

Core Viewpoint - The Portnoy Law Firm has initiated an investigation into Geron Corporation for possible securities fraud, potentially leading to a class action lawsuit for investors who have incurred losses [1][3]. Group 1: Investigation Details - The investigation focuses on Geron Corporation's communications regarding the anticipated launch and growth potential of its drug Rytelo (imetelstat) [3]. - Allegations include that Geron misled investors by expressing confidence in the drug's market potential while downplaying risks related to monitoring requirements and competition [3]. Group 2: Investor Actions - Investors who have lost money are encouraged to contact attorney Lesley F. Portnoy for a complimentary case evaluation and to discuss their legal rights [2][4]. - The Portnoy Law Firm has a history of recovering over $5.5 billion for investors affected by corporate wrongdoing [4].

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 [1][2] Summary by Relevant Sections Class Action Complaint - The complaint was filed on March 14, 2025, covering a Class Period from February 28, 2024, to February 25, 2025 [1] - Allegations include that Geron's management provided misleading information regarding the launch and growth potential of Rytelo (imetelstat) [2] - The complaint claims that the management expressed confidence in addressing the unmet need for the drug while downplaying risks related to monitoring requirements and competition [2] Investigation Details - The investigation focuses on whether Geron's board of directors has breached their fiduciary duties to the company [1] - Long-term stockholders are encouraged to reach out for more information regarding their rights and the ongoing investigation [3] Law Firm Background - Bragar Eagel & Squire, P.C. is a recognized law firm that represents investors in various complex litigations [4]

Core Insights - The article discusses the trading strategies around biotech stocks, particularly focusing on events such as trial results and NDA/BLA approvals [1] - It emphasizes the importance of understanding FDA regulations in the biotech industry [1] Group 1: Trading Strategies - The focus is on trading biotech stocks based on significant events that can impact stock prices, such as trial results and regulatory approvals [1] - The article suggests that these events create opportunities for traders to capitalize on price movements [1] Group 2: Industry Regulations - The biotech industry is heavily regulated by the FDA, which plays a crucial role in the approval process for new drugs and therapies [1] - Understanding the regulatory landscape is essential for making informed investment decisions in biotech stocks [1]

PART I. FINANCIAL INFORMATION This section presents Geron Corporation's unaudited condensed consolidated financial statements and management's discussion and analysis for the quarter ended June 30, 2025 [Item 1. Financial Statements (Unaudited)](index=3&type=section&id=Item%201.%20Financial%20Statements%20(Unaudited)) This section presents Geron Corporation's unaudited condensed consolidated financial statements for the quarter ended June 30, 2025, with detailed notes on accounting policies and financial positions [Condensed Consolidated Balance Sheets](index=3&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) Total assets decreased to $555.2 million by June 30, 2025, primarily due to reduced marketable securities, with a slight decline in stockholders' equity | Metric (in thousands) | June 30, 2025 | December 31, 2024 | | :-------------------- | :------------ | :---------------- | | Total Assets | $555,198 | $593,781 | | Total Liabilities | $284,667 | $313,255 | | Total Stockholders' Equity | $259,531 | $280,320 | - Cash and cash equivalents decreased from **$79.0 million** to **$77.7 million**[14](index=14&type=chunk) - Marketable securities (current and noncurrent) decreased from **$422.1 million** to **$353.0 million**[14](index=14&type=chunk)[38](index=38&type=chunk)[39](index=39&type=chunk) [Condensed Consolidated Statements of Operations](index=4&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) Total revenues significantly increased due to RYTELO sales, leading to a substantial year-over-year reduction in net loss for the periods ended June 30, 2025 | Metric (in thousands) | 3 Months Ended June 30, 2025 | 3 Months Ended June 30, 2024 | 6 Months Ended June 30, 2025 | 6 Months Ended June 30, 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) | | Basic and diluted net loss per share | $(0.02) | $(0.10) | $(0.05) | $(0.19) | - Product revenue, net, increased significantly due to the commercial launch of RYTELO in June 2024[17](index=17&type=chunk)[35](index=35&type=chunk)[128](index=128&type=chunk) - Research and development expenses decreased by **29%** for the three months and **39%** for the six months ended June 30, 2025, primarily due to decreased clinical trial costs and capitalization of manufacturing costs post-FDA approval[17](index=17&type=chunk)[136](index=136&type=chunk)[140](index=140&type=chunk) [Condensed Consolidated Statements of Comprehensive Loss](index=5&type=section&id=Condensed%20Consolidated%20Statements%20of%20Comprehensive%20Loss) Comprehensive loss decreased for both three and six months ended June 30, 2025, consistent with the reduced net loss | Metric (in thousands) | 3 Months Ended June 30, 2025 | 3 Months Ended June 30, 2024 | 6 Months Ended June 30, 2025 | 6 Months Ended June 30, 2024 | | :-------------------- | :--------------------------- | :--------------------------- | :--------------------------- | :--------------------------- | | Net loss | $(16,375) | $(67,383) | $(36,210) | $(122,773) | | Comprehensive loss | $(16,562) | $(67,647) | $(36,354) | $(123,495) | [Condensed Consolidated Statements of Stockholders' Equity](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Stockholders'%20Equity) Stockholders' equity decreased to $259.5 million by June 30, 2025, reflecting net loss, other comprehensive loss, and equity activities | Metric (in thousands) | December 31, 2024 | June 30, 2025 | | :-------------------- | :---------------- | :------------ | | Total Stockholders' Equity | $280,320 | $259,531 | | Accumulated Deficit | $(1,772,341) | $(1,808,551) | - **30,369,830 shares** of common stock were issued from the net exercise of pre-funded warrants in Q1 2025[20](index=20&type=chunk) - Stock-based compensation for equity-based awards totaled **$14.1 million** for the six months ended June 30, 2025[20](index=20&type=chunk)[91](index=91&type=chunk) [Condensed Consolidated Statements of Cash Flows](index=8&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Net cash used in operating activities decreased due to reduced net loss, while investing activities provided cash and financing activities provided less cash year-over-year | Metric (in thousands) | 6 Months Ended June 30, 2025 | 6 Months Ended June 30, 2024 | | :-------------------- | :--------------------------- | :--------------------------- | | Net cash used in operating activities | $(75,394) | $(115,731) | | Net cash provided by (used in) investing activities | $72,754 | $(1,939) | | Net cash provided by financing activities | $1,347 | $164,631 | | Net increase in cash, cash equivalents and restricted cash | $(1,272) | $46,930 | | Cash, cash equivalents and restricted cash at end of period | $79,604 | $118,068 | - The decrease in net cash used in operations was primarily due to a decrease in net loss of **$36.2 million**[162](index=162&type=chunk) - Net cash provided by investing activities increased due to decreased purchases of marketable securities[163](index=163&type=chunk) - Financing activities in 2024 included **$141.0 million** from an underwriting offering of common stock and pre-funded warrants[164](index=164&type=chunk) [Notes to Condensed Consolidated Financial Statements](index=9&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) These notes provide detailed disclosures on accounting policies, revenue recognition, inventory, debt, contingencies, and other financial statement context [1. BASIS OF PRESENTATION, PRINCIPLES OF CONSOLIDATION, USE OF ESTIMATES AND RECENT ACCOUNTING PRONOUNCEMENTS](index=11&type=section&id=1.%20BASIS%20OF%20PRESENTATION,%20PRINCIPLES%20OF%20CONSOLIDATION,%20USE%20OF%20ESTIMATES%20AND%20RECENT%20ACCOUNTING%20PRONOUNCEMENTS) This note details the basis of financial statement presentation, consolidation principles, use of estimates, and evaluation of new accounting pronouncements - The financial statements are prepared in accordance with U.S. GAAP for interim financial information and include Geron Corporation and its wholly-owned subsidiaries, Geron UK Limited and Geron Netherlands B.V[26](index=26&type=chunk)[27](index=27&type=chunk)[28](index=28&type=chunk) - Management is evaluating the impact of ASU 2024-03, 'Income Statement - Reporting Comprehensive Income - Expense Disaggregation Disclosures,' effective for fiscal years beginning after December 15, 2026[33](index=33&type=chunk) [2. REVENUE RECOGNITION](index=12&type=section&id=2.%20REVENUE%20RECOGNITION) This note details product revenue from U.S. RYTELO sales, including gross revenue and gross-to-net adjustments for the periods ended June 30, 2025 - RYTELO U.S. sales are the sole source of product revenue, commencing in June 2024[35](index=35&type=chunk)[128](index=128&type=chunk) | (in thousands) | Three Months Ended June 30, 2025 | Six Months Ended June 30, 2025 | | :--------------- | :------------------------------- | :----------------------------- | | Gross product revenue | $57,874 | $103,186 | | Total gross-to-net adjustments | $(8,867) | $(14,743) | | Net product revenue | $49,007 | $88,443 | - Total gross-to-net adjustments were **15.3%** and **14.3%** of gross product revenue for the three and six months ended June 30, 2025, respectively, and are expected to be in the mid- to high-teens percentage for the remainder of 2025[129](index=129&type=chunk)[130](index=130&type=chunk) [3. INVENTORY](index=12&type=section&id=3.%20INVENTORY) This note details RYTELO-related inventory, showing a significant increase in total inventory, especially work-in-process and finished goods, by June 30, 2025 | (in thousands) | June 30, 2025 | December 31, 2024 | | :--------------- | :------------ | :---------------- | | Raw materials | $7,581 | $4,904 | | Work-in-process | $47,012 | $30,093 | | Finished goods | $14,532 | $3,717 | | Total inventory | $69,125 | $38,714 | [4. FAIR VALUE MEASUREMENTS](index=13&type=section&id=4.%20FAIR%20VALUE%20MEASUREMENTS) This note details fair value measurements for cash equivalents and marketable securities, categorizing them by input observability, and discusses credit risk concentrations | (in thousands) | June 30, 2025 Fair Value | December 31, 2024 Fair Value | | :--------------- | :----------------------- | :--------------------------- | | Money market funds | $37,892 | $46,802 | | Certificate of deposit | $273 | $273 | | U.S. Treasury securities | $22,785 | $30,570 | | Commercial paper | $123,995 | $185,201 | | Corporate notes | $204,695 | $202,527 | | Total | $393,641 | $474,121 | - Fair value measurements are categorized into Level 1 (quoted prices in active markets) and Level 2 (observable inputs other than quoted prices)[44](index=44&type=chunk)[46](index=46&type=chunk)[50](index=50&type=chunk) - Five customers accounted for **100%** of gross accounts receivable as of June 30, 2025: McKesson Financial Center (**44%**), ASD Specialty Healthcare LLC (**34%**), Cardinal Health Inc. (**20%**), Biologics Inc (**1%**), and Sina Drug (**1%**)[55](index=55&type=chunk)[58](index=58&type=chunk) [5. ACCRUED LIABILITIES](index=19&type=section&id=5.%20ACCRUED%20LIABILITIES) Accrued liabilities decreased to $26.3 million by June 30, 2025, mainly due to reduced CRO, clinical trial costs, and compensation | (In thousands) | June 30, 2025 | December 31, 2024 | | :--------------- | :------------ | :---------------- | | CRO and clinical trial costs | $6,689 | $18,968 | | Manufacturing activities | $15,260 | $11,839 | | Accrued liabilities | $26,294 | $35,549 | [6. DEBT](index=19&type=section&id=6.%20DEBT) This note details the Pharmakon Loan Agreement and the Royalty Pharma Agreement, outlining debt facilities and royalty payment obligations - Geron entered into a Pharmakon Loan Agreement for up to **$250.0 million**, with **$125.0 million** (Tranche A) funded on November 1, 2024, bearing interest at **5.75%** plus three-month SOFR (with a **3.00%** floor)[60](index=60&type=chunk)[61](index=61&type=chunk) - The Pharmakon Loan Agreement includes two additional tranches: Tranche B (**$75.0 million**) and Tranche C (**$50.0 million**), available until December 31, 2025, subject to certain conditions[60](index=60&type=chunk) - Geron received an upfront payment of **$125.0 million** from Royalty Pharma in exchange for tiered royalty payments on future U.S. net sales of RYTELO, ranging from **7.75%** to **1.0%**, capped at **1.65x** or **2.0x** the Purchase Price[67](index=67&type=chunk)[69](index=69&type=chunk) | (in thousands) | Liability Related to Sale of Future Royalties | | :--------------- | :-------------------------------------------- | | Carrying value at December 31, 2024 | $125,912 | | Interest expense recognized | $5,079 | | Royalty payments | $(3,023) | | Carrying value at June 30, 2025 | $127,968 | [7. CONTINGENCIES AND UNCERTAINTIES](index=22&type=section&id=7.%20CONTINGENCIES%20AND%20UNCERTAINTIES) This note addresses legal proceedings, including securities class action and shareholder derivative lawsuits, and details commercial purchase commitments - Geron and its officers are defendants in two consolidated securities class action lawsuits and three consolidated shareholder derivative lawsuits, alleging false and misleading statements regarding RYTELO's commercial potential[75](index=75&type=chunk)[77](index=77&type=chunk)[78](index=78&type=chunk) - The company has noncancelable commercial purchase commitments for approximately **$124.7 million** for RYTELO manufacturing as of June 30, 2025[83](index=83&type=chunk) [8. STOCKHOLDERS' EQUITY](index=24&type=section&id=8.%20STOCKHOLDERS'%20EQUITY) This note details changes in stockholders' equity, including warrant exercises, stock-based compensation, and amendments to equity incentive plans - **30,369,830 shares** of common stock were issued in Q1 2025 from the net exercise of pre-funded warrants[20](index=20&type=chunk)[85](index=85&type=chunk) | (In thousands) | 3 Months Ended June 30, 2025 | 6 Months Ended June 30, 2025 | | :--------------- | :--------------------------- | :--------------------------- | | Research and development | $2,521 | $4,917 | | Selling, general and administrative | $4,217 | $9,230 | | Total stock-based compensation expense | $6,738 | $14,147 | - Stockholders approved amendments to increase shares issuable under the 2018 Equity Incentive Plan by **20 million shares** and the 2014 Employee Stock Purchase Plan by **6 million shares** in May 2025[93](index=93&type=chunk) [9. SEGMENT REPORTING](index=27&type=section&id=9.%20SEGMENT%20REPORTING) Geron operates as a single reportable segment focused on hematologic malignancies, with RYTELO U.S. sales as its sole product revenue source - Geron has identified one operating and reportable segment, focused on developing therapies for hematologic malignancies[100](index=100&type=chunk)[101](index=101&type=chunk) - The CODM reviews segment profit/loss based on net (loss) income and forecast-to-actual variances for significant expenses, and assets based on total consolidated assets[102](index=102&type=chunk) [10. SUBSEQUENT EVENTS](index=29&type=section&id=10.%20SUBSEQUENT%20EVENTS) An amendment to the 2018 Inducement Award Plan increased shares issuable by 11 million for inducement awards, effective August 1, 2025 - The 2018 Inducement Award Plan was amended to increase shares issuable by **11 million** to **51.3 million**, effective August 1, 2025, for inducement awards to new personnel[107](index=107&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=26&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) This section discusses Geron's business as a commercial-stage biopharmaceutical company, focusing on RYTELO's performance, critical accounting policies, and liquidity [OVERVIEW](index=30&type=section&id=OVERVIEW) Geron is a commercial-stage biopharmaceutical company focused on RYTELO for blood cancers, with U.S. launch in June 2024 and EU authorization in March 2025 - Geron is a commercial-stage biopharmaceutical company with RYTELO (imetelstat) as its first-in-class telomerase inhibitor[111](index=111&type=chunk) - RYTELO was approved by the U.S. FDA on June 6, 2024, and commercially launched in the U.S. in June 2024 for adult patients with lower-risk MDS[111](index=111&type=chunk) - Marketing authorization for RYTELO in the EU was granted in March 2025, with planned commercialization in select EU markets in 2026 through third parties[111](index=111&type=chunk) - The Phase 3 IMpactMF clinical trial for relapsed/refractory myelofibrosis is over **95%** enrolled, with interim OS analysis expected in H2 2026 and final analysis in H2 2028[113](index=113&type=chunk) - Net product revenue was approximately **$49.0 million** in Q2 2025, **$39.4 million** in Q1 2025, and **$47.5 million** in Q4 2024, showing variability[119](index=119&type=chunk) - Strategy to drive U.S. sales growth focuses on increasing brand awareness, refining marketing efforts, and expanding key opinion leader support[120](index=120&type=chunk) [CRITICAL ACCOUNTING POLICIES AND ESTIMATES](index=32&type=section&id=CRITICAL%20ACCOUNTING%20POLICIES%20AND%20ESTIMATES) Financial statements rely on continuous estimates and assumptions, with no significant changes in critical accounting policies during the reporting period - Preparation of financial statements requires management to make estimates and assumptions affecting reported amounts[121](index=121&type=chunk)[122](index=122&type=chunk) - No significant changes in critical accounting policies and estimates occurred during the three and six months ended June 30, 2025[124](index=124&type=chunk) [RESULTS OF OPERATIONS](index=32&type=section&id=RESULTS%20OF%20OPERATIONS) Operating results show substantial RYTELO revenue growth, significantly reducing net loss, with decreased R&D and increased SG&A expenses for commercialization | Metric (in thousands) | 3 Months Ended June 30, 2025 | 3 Months Ended June 30, 2024 | 6 Months Ended June 30, 2025 | 6 Months Ended June 30, 2024 | | :-------------------- | :--------------------------- | :--------------------------- | :--------------------------- | :--------------------------- | | Product revenues, net | $49,007 | $780 | $88,443 | $780 | | Total revenues | $49,036 | $882 | $88,639 | $1,186 | | Research and development | $21,736 | $30,779 | $36,814 | $60,152 | | Selling, general and administrative | $38,564 | $39,419 | $78,587 | $66,484 | | Net income (loss) | $(16,375) | $(67,383) | $(36,210) | $(122,773) | - Product revenues, net, for the three and six months ended June 30, 2025, were approximately **$49.0 million** and **$88.4 million**, respectively, compared to **$0.8 million** for the same periods in 2024, following RYTELO's FDA approval and commercial launch[128](index=128&type=chunk) - Research and development expenses decreased by **29%** (3 months) and **39%** (6 months) due to reduced IMerge MDS study activity and capitalization of manufacturing costs post-approval[136](index=136&type=chunk)[140](index=140&type=chunk) - Selling, general and administrative expenses decreased by **2%** for the three months but increased by **18%** for the six months, primarily due to higher personnel-related expenses supporting RYTELO commercialization[136](index=136&type=chunk)[141](index=141&type=chunk) - Interest expense increased by **157%** (3 months) and **148%** (6 months) due to the Pharmakon Loan Agreement and Royalty Pharma Agreement, both entered in November 2024[143](index=143&type=chunk) [LIQUIDITY AND CAPITAL RESOURCES](index=36&type=section&id=LIQUIDITY%20AND%20CAPITAL%20RESOURCES) Liquidity decreased to $432.6 million by June 30, 2025, with existing funds and RYTELO revenues expected to cover foreseeable operating requirements, though additional funding may be needed - Cash, cash equivalents, restricted cash, and marketable securities totaled **$432.6 million** as of June 30, 2025, down from **$502.9 million** at December 31, 2024[146](index=146&type=chunk) - The decrease in liquidity was primarily due to cash used in operations, partially offset by accounts receivable proceeds[146](index=146&type=chunk) - Net cash used in operations for the six months ended June 30, 2025, was **$75.4 million**, a decrease from **$115.7 million** in the prior year[162](index=162&type=chunk) - Net cash provided by investing activities was **$72.8 million** for the six months ended June 30, 2025, compared to net cash used of **$1.9 million** in the prior year, reflecting decreased marketable securities purchases[163](index=163&type=chunk) - Net cash provided by financing activities was **$1.3 million** for the six months ended June 30, 2025, significantly lower than **$164.6 million** in the prior year, which included proceeds from a public offering[164](index=164&type=chunk) - The company has commercial purchase commitments of approximately **$124.7 million** for RYTELO manufacturing as of June 30, 2025[167](index=167&type=chunk) - Long-term principal debt balance was **$119.0 million** as of June 30, 2025, from the Tranche A Loan under the Pharmakon Loan Agreement[168](index=168&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=41&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) No material changes occurred in market risk disclosures during the six months ended June 30, 2025, compared to the 2024 Form 10-K - No material changes to market risk disclosures occurred during the six months ended June 30, 2025[172](index=172&type=chunk) [Item 4. Controls and Procedures](index=41&type=section&id=Item%204.%20Controls%20and%20Procedures) Disclosure controls and procedures were effective as of June 30, 2025, with no material changes in internal control over financial reporting during the quarter - Disclosure controls and procedures were evaluated and deemed effective at the reasonable assurance level as of June 30, 2025[173](index=173&type=chunk) - No material changes in internal control over financial reporting occurred during the quarter[174](index=174&type=chunk) PART II. OTHER INFORMATION This section provides other information, including legal proceedings, risk factors, equity sales, defaults, and exhibits [Item 1. Legal Proceedings](index=42&type=section&id=Item%201.%20Legal%20Proceedings) This section refers to Note 7 for details on legal proceedings, including securities class action and shareholder derivative lawsuits - Legal proceedings are detailed in Note 7, including securities class action and shareholder derivative lawsuits[177](index=177&type=chunk) [Item 1A. Risk Factors](index=42&type=section&id=Item%201A.%20Risk%20Factors) This section outlines significant risks impacting Geron's business, including RYTELO commercialization, regulatory approvals, financial performance, and intellectual property [Risk Factor Summary](index=42&type=section&id=Risk%20Factor%20Summary) This summary highlights key risks, including RYTELO's commercial success, regulatory challenges, competition, manufacturing reliance, historical losses, and stock price volatility - The company's near-term prospects are wholly dependent on RYTELO, and its commercialization success is unproven[181](index=181&type=chunk)[189](index=189&type=chunk) - Maintaining regulatory approvals for RYTELO in the U.S. and EU is critical, and failure to do so would severely affect the business[180](index=180&type=chunk) - Competition from superior or more cost-effective products could significantly impact RYTELO's viability[181](index=181&type=chunk) - The company has a history of net losses and may not achieve consistent future profitability[186](index=186&type=chunk) [RISKS RELATED TO THE COMMERCIALIZATION OF RYTELO® (IMETELSTAT)](index=44&type=section&id=RISKS%20RELATED%20TO%20THE%20COMMERCIALIZATION%20OF%20RYTELO%C2%AE%20(IMETELSTAT)) Risks include limited commercialization experience, challenges in sales growth, pricing, reimbursement, healthcare acceptance, competition, and reliance on third-party distributors - Geron has limited experience commercializing RYTELO, and its success depends on effective sales, marketing, and distribution[189](index=189&type=chunk)[191](index=191&type=chunk) - RYTELO sales trends have been variable, with net product revenue of **$49.0 million** in Q2 2025, **$39.4 million** in Q1 2025, and **$47.5 million** in Q4 2024[191](index=191&type=chunk) - Maintaining acceptable prices and adequate reimbursement from third-party payors is critical for RYTELO's market acceptance[196](index=196&type=chunk)[198](index=198&type=chunk) - RYTELO must be accepted by the healthcare community, which can be slow to adopt new technologies, and faces competition from existing and developing therapies[199](index=199&type=chunk)[204](index=204&type=chunk) [RISKS RELATED TO REGULATORY APPROVAL OF RYTELO](index=50&type=section&id=RISKS%20RELATED%20TO%20REGULATORY%20APPROVAL%20OF%20RYTELO) Risks include maintaining U.S. and EU regulatory approvals, obtaining new approvals, post-marketing requirements, global trade issues, and potential loss of orphan drug designation - Failure to maintain regulatory approvals for RYTELO in the U.S. and EU for lower-risk MDS could severely harm the business[216](index=216&type=chunk) - RYTELO's regulatory approval is subject to post-marketing requirements and commitments, including long-term safety assessment in the IMerge trial and evaluating alternative dosing regimens[222](index=222&type=chunk) - The company may be unable to obtain regulatory approval for RYTELO in other jurisdictions or for new indications, facing lengthy and unpredictable review processes[226](index=226&type=chunk)[227](index=227&type=chunk) - Global trade issues, including tariffs and trade restrictions, could increase costs and negatively impact RYTELO sales, particularly for API manufactured in South Korea and drug product in Italy[235](index=235&type=chunk)[236](index=236&type=chunk) - Orphan drug designation for RYTELO in MDS and MF may not be maintained, which would eliminate market exclusivity benefits[238](index=238&type=chunk)[239](index=239&type=chunk) [RISKS RELATED TO COMPLIANCE WITH HEALTHCARE LAWS](index=57&type=section&id=RISKS%20RELATED%20TO%20COMPLIANCE%20WITH%20HEALTHCARE%20LAWS) Geron faces risks from strict enforcement of pharmaceutical promotion regulations, scrutiny over patient assistance, compliance with healthcare laws, and health policy changes - The FDA, DOJ, and other regulatory authorities strictly enforce regulations on pharmaceutical product promotion, and violations could lead to significant civil, criminal, and administrative penalties[248](index=248&type=chunk)[249](index=249&type=chunk) - Enhanced scrutiny over donations to patient assistance programs could require program modifications, harm reputation, and increase expenses[250](index=250&type=chunk)[252](index=252&type=chunk) - Business activities are subject to fraud and abuse, transparency, and health information privacy and security laws (e.g., HIPAA, HITECH), with potential for substantial penalties for non-compliance[253](index=253&type=chunk)[254](index=254&type=chunk) - Health policy changes and healthcare reform in the U.S. and abroad, including drug pricing controls, could adversely impact RYTELO sales and financial results[256](index=256&type=chunk)[258](index=258&type=chunk) [RISKS RELATED TO THE FURTHER DEVELOPMENT OF IMETELSTAT](index=60&type=section&id=RISKS%20RELATED%20TO%20THE%20FURTHER%20DEVELOPMENT%20OF%20IMETELSTAT) Further imetelstat development faces risks including safety/efficacy data generation, clinical trial delays, undesirable side effects, and reliance on third parties - Further development of imetelstat for other myeloid hematologic malignancies depends on generating sufficient safety and efficacy data, obtaining additional capital, and maintaining regulatory clearances[260](index=260&type=chunk) - Clinical trials could be interrupted, delayed, or terminated due to patient recruitment challenges, operational delays, regulatory holds, or manufacturing issues[262](index=262&type=chunk)[263](index=263&type=chunk) - RYTELO may cause undesirable side effects (e.g., hematologic toxicities, hepatotoxicity, bleeding events) that could halt commercialization or delay regulatory approval for new indications[265](index=265&type=chunk)[267](index=267&type=chunk)[269](index=269&type=chunk)[270](index=270&type=chunk) - Success in early clinical trials does not predict success in later trials, and IMpactMF results may differ from IMbark data[275](index=275&type=chunk)[276](index=276&type=chunk)[277](index=277&type=chunk) - Reliance on third parties (CROs, investigators) to conduct clinical trials introduces risks of non-compliance with protocols, GCP, or regulatory requirements, potentially delaying or halting development[280](index=280&type=chunk)[281](index=281&type=chunk)[282](index=282&type=chunk) [RISKS RELATED TO MANUFACTURING RYTELO](index=66&type=section&id=RISKS%20RELATED%20TO%20MANUFACTURING%20RYTELO) Manufacturing RYTELO faces risks including consistent production, reliance on single-source API manufacturers, regulatory compliance, and supply chain failures - Manufacturing RYTELO is complex and subject to risks including consistent production, sufficient yields, quality control, and supply chain issues[290](index=290&type=chunk)[291](index=291&type=chunk) - The company relies on a small group of third-party manufacturers, including a single source for RYTELO's API[293](index=293&type=chunk) - Failure by third-party manufacturers to perform or comply with regulatory requirements could interrupt or limit RYTELO supply for commercial and clinical uses[293](index=293&type=chunk)[294](index=294&type=chunk) [RISKS RELATED TO OUR OPERATING RESULTS AND FINANCIAL POSITION](index=68&type=section&id=RISKS%20RELATED%20TO%20OUR%20OPERATING%20RESULTS%20AND%20FINANCIAL%20POSITION) Geron has a history of net losses, with uncertain future profitability dependent on RYTELO sales, and faces risks from unpredictable operating results and capital needs - Geron has incurred net losses since 1990 (except for one year) and had an accumulated deficit of approximately **$1.8 billion** as of June 30, 2025[297](index=297&type=chunk) - Operating results are unpredictable and may fluctuate due to RYTELO sales, reimbursement, cost of sales, royalty payments, and R&D investments[298](index=298&type=chunk)[300](index=300&type=chunk) - Financial projections and estimates are subject to significant risks and uncertainties, including market demand, reimbursement, supply chain costs, and regulatory changes[303](index=303&type=chunk) - Failure to obtain additional capital, if needed, could force delays or abandonment of RYTELO development or commercialization[305](index=305&type=chunk) - As of June 30, 2025, the company had **$432.6 million** in cash, cash equivalents, restricted cash, and marketable securities, which are believed sufficient for foreseeable operating requirements, but additional funding may be needed[305](index=305&type=chunk) [RISKS RELATED TO OUR INDEBTEDNESS AND ROYALTY PAYMENT OBLIGATIONS](index=72&type=section&id=RISKS%20RELATED%20TO%20OUR%20INDEBTEDNESS%20AND%20ROYALTY%20PAYMENT%20OBLIGATIONS) Indebtedness and royalty obligations could adversely affect financial condition and flexibility, with potential for accelerated repayment upon covenant breaches - The Pharmakon Loan Agreement (**$125.0 million** drawn, with **$125.0 million** remaining in tranches) is secured by substantially all of Geron's assets, including intellectual property[311](index=311&type=chunk)[312](index=312&type=chunk) - Indebtedness could reduce cash for operations and R&D, and failure to comply with covenants could lead to acceleration of repayment[313](index=313&type=chunk)[317](index=317&type=chunk) - The Royalty Pharma Agreement imposes covenants on royalty payments, diligence, reporting, and restrictions on intellectual property transfers and liens related to imetelstat[321](index=321&type=chunk) [RISKS RELATED TO PROTECTING OUR INTELLECTUAL PROPERTY](index=74&type=section&id=RISKS%20RELATED%20TO%20PROTECTING%20OUR%20INTELLECTUAL%20PROPERTY) Protecting RYTELO's intellectual property, including patents and regulatory exclusivities, is critical but faces risks from challenges, inadequate terms, and infringement claims - Protection of RYTELO through patents, regulatory exclusivity, and other IP rights is critical, but patents may be challenged or narrowed[323](index=323&type=chunk)[324](index=324&type=chunk) - Method-of-use patents may not prevent generic competitors from marketing identical products for off-label uses after composition-of-matter patents expire[325](index=325&type=chunk) - Regulatory exclusivities (orphan drug, NCE, NAS) are relied upon but may be limited or withdrawn[326](index=326&type=chunk) - Patent terms may be inadequate, and patent term extensions (e.g., Hatch-Waxman, SPCs) are not guaranteed or may be limited[330](index=330&type=chunk)[331](index=331&type=chunk)[332](index=332&type=chunk) - The company may be subject to costly infringement claims from third parties, potentially limiting its ability to develop or commercialize RYTELO[357](index=357&type=chunk)[358](index=358&type=chunk) [RISKS RELATED TO MANAGING OUR GROWTH AND OTHER BUSINESS OPERATIONS](index=81&type=section&id=RISKS%20RELATED%20TO%20MANAGING%20OUR%20GROWTH%20AND%20OTHER%20BUSINESS%20OPERATIONS) Geron faces challenges in personnel retention, growth management, leadership transitions, EU commercialization, international operations, product liability, and ongoing lawsuits - Ability to commercialize and develop RYTELO depends on retaining and recruiting key personnel with expertise in sales, marketing, clinical science, and other areas[366](index=366&type=chunk) - Recent executive leadership changes (President and CEO, EVP R&D, EVP CCO) create uncertainties and could harm the business[370](index=370&type=chunk) - Plans to commercialize RYTELO in the EU through third-party collaborations may not be successful, potentially delaying or abandoning commercialization efforts[371](index=371&type=chunk) - Operating subsidiaries in the UK and Netherlands expose the company to additional costs and risks associated with international business[372](index=372&type=chunk) - Geron is a defendant in securities class action and derivative lawsuits alleging false and misleading statements about RYTELO's commercial potential, which could result in substantial damages and divert management's attention[375](index=375&type=chunk)[376](index=376&type=chunk)[378](index=378&type=chunk) [RISKS RELATED TO INFORMATION TECHNOLOGY SYSTEMS, DATA SECURITY AND DATA PRIVACY](index=85&type=section&id=RISKS%20RELATED%20TO%20INFORMATION%20TECHNOLOGY%20SYSTEMS,%20DATA%20SECURITY%20AND%20DATA%20PRIVACY) Geron faces significant risks from cybersecurity threats, data breaches, and non-compliance with evolving data privacy and security laws, potentially leading to fines and disruptions - Information technology systems and data, including those of third parties, are vulnerable to evolving cybersecurity threats (e.g., ransomware, supply-chain attacks, AI-facilitated attacks)[383](index=383&type=chunk)[384](index=384&type=chunk)[386](index=386&type=chunk) - Compromises could lead to regulatory investigations, litigation, fines, business disruptions, reputational harm, and loss of revenue[383](index=383&type=chunk)[389](index=389&type=chunk) - The company is subject to stringent and changing data privacy and security laws globally (e.g., EU GDPR, UK GDPR, CCPA), with potential for significant penalties for non-compliance[393](index=393&type=chunk)[395](index=395&type=chunk)[396](index=396&type=chunk)[398](index=398&type=chunk)[399](index=399&type=chunk) - Challenges in cross-border data transfers (e.g., from EEA/UK to U.S.) due to data localization requirements could disrupt operations and incur significant expense[397](index=397&type=chunk) [RISKS RELATED TO OUR COMMON STOCK AND FINANCIAL REPORTING](index=88&type=section&id=RISKS%20RELATED%20TO%20OUR%20COMMON%20STOCK%20AND%20FINANCIAL%20REPORTING) Stock price volatility, Nasdaq listing compliance, anti-takeover provisions, and risks related to internal controls and tax laws impact stockholders and financial reporting - Stock price has been extremely volatile, trading between **$0.89** and **$6.38** from July 2015 to June 2025, and between **$1.17** and **$5.06** from July 2024 to June 2025[403](index=403&type=chunk)[406](index=406&type=chunk) - Stock price volatility is influenced by RYTELO sales, regulatory approvals, R&D progress, competitive developments, and general market conditions[403](index=403&type=chunk)[404](index=404&type=chunk) - Failure to maintain Nasdaq Global Select Market listing requirements could negatively impact stock price and liquidity[406](index=406&type=chunk) - Provisions in charter, bylaws, and Delaware law may inhibit potential acquisition bids, potentially affecting stock price[408](index=408&type=chunk)[411](index=411&type=chunk)[413](index=413&type=chunk) - The company does not intend to pay cash dividends on common stock in the foreseeable future[419](index=419&type=chunk) - Failure to maintain effective internal controls under Section 404 of Sarbanes-Oxley Act could materially adversely affect the business and stock price[424](index=424&type=chunk)[425](index=425&type=chunk) - Changes in tax laws or regulations, and limitations on net operating loss carryforwards, could adversely affect financial condition[426](index=426&type=chunk)[429](index=429&type=chunk)[430](index=430&type=chunk) [Item 2. Unregistered Sales of Equity Securities, Use of Proceeds, and Issuer Purchases of Equity Securities](index=90&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities,%20Use%20of%20Proceeds,%20and%20Issuer%20Purchases%20of%20Equity%20Securities) No unregistered sales of equity securities, use of proceeds, or issuer purchases occurred during the reporting period - No unregistered sales of equity securities, use of proceeds, or issuer purchases of equity securities occurred[431](index=431&type=chunk) [Item 3. Defaults Upon Senior Securities](index=90&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) No defaults upon senior securities occurred during the reporting period - No defaults upon senior securities occurred[432](index=432&type=chunk) [Item 4. Mine Safety Disclosures](index=90&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) Mine Safety Disclosures are not applicable to Geron Corporation - Mine Safety Disclosures are not applicable to the registrant[433](index=433&type=chunk) [Item 5. Other Information](index=90&type=section&id=Item%205.%20Other%20Information) This section discloses Rule 10b5-1 trading arrangements adopted by directors and officers during the quarter | Name and Title | Action Taken | Date of Action | Rule 10b5-1 | Nature of Trading Arrangement | Aggregate Number of Securities | | :--------------- | :----------- | :------------- | :---------- | :---------------------------- | :----------------------------- | | V. Bryan Lawlis, Ph.D., Director | Adopted | May 15, 2025 | X | Sale | 406,000 | [Item 6. Exhibits](index=91&type=section&id=Item%206.%20Exhibits) This section lists exhibits filed with the 10-Q report, including plan amendments, CEO/CFO certifications, and XBRL financial statements - Exhibits include amendments to the 2018 Equity Incentive Plan and 2014 Employee Stock Purchase Plan[436](index=436&type=chunk) - Certifications from the Chief Executive Officer and Chief Financial Officer are filed pursuant to Sections 302(a) and 906 of the Sarbanes-Oxley Act of 2002[436](index=436&type=chunk) - Financial statements are provided in Inline Extensible Business Reporting Language (iXBRL) format[436](index=436&type=chunk) [SIGNATURES](index=93&type=section&id=SIGNATURES) The report was signed by Michelle Robertson, EVP, CFO, and Treasurer, on August 6, 2025 - The report was signed by Michelle Robertson, EVP, CFO, and Treasurer, on August 6, 2025[442](index=442&type=chunk)

Financial Data and Key Metrics Changes - Q2 Rytello net revenues were $49 million, representing an increase of approximately 24% over the first quarter [5][29] - As of June 30, 2025, cash and marketable securities were approximately $433 million, up from $503 million as of December 31, 2024 [29] - Research and development expenses for Q2 were $22 million, down from $31 million for the same period in 2024, primarily due to lower clinical trial costs [30] Business Line Data and Key Metrics Changes - Demand growth in Q2 was 17% higher compared to Q1, with approximately 1,000 sites of care utilizing Rytello, an increase of about 400 new sites since the beginning of the year [13][14] - Approximately two-thirds of accounts that previously ordered Rytello have reordered in Q2 [14] - Payer access improved, with approximately 90% of US covered lives now under favorable Rytello medical coverage policies, up from 85% in Q1 [16] Market Data and Key Metrics Changes - The company is focused on increasing brand awareness among US hematologists treating lower-risk MDS patients, with positive feedback on educational efforts [7][23] - The company plans to expand its commercial sales force and customer-facing roles by over 20% to enhance KOL support and advocacy [8][20] Company Strategy and Development Direction - The primary strategy remains the successful commercialization of Rytello in the US, with a focus on increasing brand awareness and physician education [5][10] - The company is preparing for the launch of Rytello in select EU markets next year, maintaining financial discipline in investments for this launch [10][22] - The appointment of Harout Semerjian as the new President and CEO is expected to drive shareholder value and enhance the company's strategic direction [4][12] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the execution of commercial strategies and the potential for continued growth, particularly in the US market [11][54] - The company is optimistic about the enrollment momentum in the Phase III IMPACT MF trial, expecting completion by year-end [11][25] Other Important Information - The company has doubled the size of its medical affairs team to enhance community awareness and KOL advocacy [23] - The gross-to-net percentage remained in the mid-teens from Q1 to Q2, consistent with previous guidance [29] Q&A Session Summary Question: How many active patients are now receiving Rytello? - The company estimates that there are at least 600 active patients based on the number of accounts that have prescribed Rytello [36] Question: How sustainable is the 17% quarter-over-quarter demand growth? - The company focuses on business drivers such as new patient starts and duration of treatment, with positive trends observed in physician prescribing behavior [42][44] Question: What was the biggest issue that held back the launch in Q4 and Q1? - Management identified the need to increase awareness, ensure prescribing comfort, and engage KOLs as key strategies that have been pivoted since March [52][53] Question: Any qualitative insights on early Q3 demand trends? - The company sees conscious optimism in demand trends based on internal sales data and claims data [62] Question: Any anecdotes about the type of physicians currently prescribing Rytello in earlier lines? - The company noted that earlier line use is seen among physicians who have had patient success in later lines of therapy [71] Question: What is the EU commercialization strategy? - The company is focused on securing the highest possible reimbursable rate and is engaged with potential partners for commercialization in the EU [81][84]

Commercial Performance - RYTELO Q2 2025 sales reached $49 million[12] - There was an approximate 17% demand increase for RYTELO in Q2 2025 compared to Q1 2025[14] - Approximately 30% of new RYTELO patients starts are in the 1st and 2nd line of treatment[14] - RYTELO has secured favorable coverage policies for approximately 90% of covered lives[14] - Since approval, approximately 400 new ordering accounts have been added year-to-date[14] Clinical Development - The Phase 3 IMpactMF trial is expected to be 100% enrolled by the end of 2025[11, 22] - An interim analysis of the IMpactMF trial is expected in the second half of 2026, with the final analysis anticipated in the second half of 2028[22] Financial Status - The company's cash and marketable securities totaled $432.6 million as of June 30, 2025[25] - Q2 2025 total operating expenses were $61.5 million[25] - The company anticipates operating expenses in the range of $270 million to $285 million for 2025[25]