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]

[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].