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]

[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]