Financial Data and Key Metrics Changes - For Q3 2025, total net revenue was $47 million, an increase from $28 million in Q3 2024 [23] - Cash and marketable securities as of September 30, 2025, were approximately $420 million, down from $503 million as of December 31, 2024 [23] - Research and development expenses for Q3 2025 were $21 million, compared to $20 million for the same period in 2024 [24] - Selling, general and administrative expenses for Q3 2025 were $39 million, up from $36 million in Q3 2024 [24] - The company expects total operating expenses for fiscal year 2025 to be between $250 million and $260 million, below previous guidance of $270 million to $285 million [24] Business Line Data and Key Metrics Changes - Net product revenue for Rytelo was $47.2 million for Q3 2025, with a 3% decrease in demand compared to the previous quarter [5][6] - New patient starts in first and second lines increased to 36% from 30% in Q2 2025, but did not offset discontinuations in later lines [6] - Prescribing accounts increased by 15% in Q3, adding approximately 150 new ordering accounts, bringing the total to 1,150 [6] Market Data and Key Metrics Changes - The company completed its first shipment of Rytelo to Germany under a named patient early access program, preparing for commercialization in select EU markets in 2026 [7] - The company is focusing on increasing awareness of Rytelo among US healthcare providers (HCPs) and expanding its presence in hematology forums [9][10] Company Strategy and Development Direction - The company aims to maximize the impact of Rytelo for patients while advancing its first-in-class telomerase inhibitor to benefit more patients in the future [12] - Key strategic initiatives include increasing awareness among US HCPs, expanding relationships with key opinion leaders (KOLs), and enhancing community site penetration [16][18] - The company is also focusing on investigator-sponsored trials to broaden the clinical evidence base for imetelstat [18] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the future, emphasizing the need for improved execution and alignment to drive Rytelo's growth [12][26] - The company acknowledges that building brand awareness and shifting physician behavior takes time, with a focus on 2026 as a growth story [64][65] - Management is confident in the potential of Rytelo to address unmet needs in lower-risk MDS patients [28][62] Other Important Information - The company has identified four initial actions to enhance execution and support future revenue growth, including increasing awareness and education for HCPs [9] - The company plans to engage with patient advocacy organizations and professional societies to raise awareness about lower-risk MDS and Rytelo [15] Q&A Session Summary Question: Insights on current gross-to-net and demand decrease - Management confirmed that the mid-to-high teens range for gross-to-net remains applicable and discussed factors affecting demand, including discontinuations in later lines [32][35] Question: Growth in ordering accounts and prescribing depth - Management reported a 15% sequential increase in ordering accounts, with 80% of accounts having reordered in the last quarter, emphasizing the need for depth in prescribing [41][43] Question: Revised operating expense guidance - Management highlighted savings from CMC investments and slowed infrastructure investments, confirming a revised operating expense guidance of $250 million to $260 million for 2025 [49][50] Question: Sales force effectiveness and EU partner search - Management confirmed the sales force is fully hired and focused on effectiveness, while ongoing discussions for EU partnerships are taking place [53][56] Question: Confidence in awareness as a growth lever - Management expressed high confidence in identifying issues and emphasized that increasing brand awareness is crucial for growth, with 2026 seen as a pivotal year [61][64]

Q3 2025 Earnings Call November 5, 2025 Forward-Looking Statements During the course of this presentation and question-and-answer session, there will be forward-looking statements regarding future events, performance, plans, expectations and other projections, including those relating to: Actual events or results could differ materially; refer to the discussion under the heading "Risk Factors" in Geron's most recent periodic report filed with the SEC, which identifies important factors that could cause actua ...

Financial Performance - Achieved $47.2 million in net product revenue from RYTELO® in Q3 2025, a significant increase from $28.2 million in Q3 2024[8] - Product revenue for Q3 2025 reached $47.167 million, a significant increase of 67.1% compared to $28.209 million in Q3 2024[26] - Total revenues for the nine months ended September 30, 2025, were $135.866 million, up from $29.457 million in the same period of 2024, representing a growth of 360.5%[26] - Reported a net loss of $18.4 million, or $0.03 per share, compared to a net loss of $26.4 million, or $0.04 per share, for the same period in 2024[7] - The net loss for Q3 2025 was $18.428 million, an improvement from a net loss of $26.447 million in Q3 2024[26] - Basic and diluted net loss per share for Q3 2025 was $0.03, compared to $0.04 in Q3 2024[26] Expenses - Total costs and operating expenses for Q3 2025 were $61.1 million, up from $56.5 million in Q3 2024[9] - Research and development expenses increased to $21.1 million in Q3 2025 from $20.2 million in Q3 2024, primarily due to increased CMC and personnel-related expenses[10] - Research and development expenses for Q3 2025 were $21.070 million, slightly increasing from $20.153 million in Q3 2024[26] - Selling, general and administrative expenses rose to $39.0 million in Q3 2025, compared to $35.9 million in Q3 2024, driven by increased sales and marketing personnel[11] - Selling, general and administrative expenses rose to $39.001 million in Q3 2025, compared to $35.877 million in Q3 2024, reflecting an increase of 5.9%[26] Cash and Assets - As of September 30, 2025, cash and marketable securities totaled approximately $421.5 million, down from $502.9 million as of December 31, 2024[6] - Total current assets as of September 30, 2025, amounted to $522.342 million, an increase from $490.992 million as of December 31, 2024[28] - Current liabilities were $87.712 million as of September 30, 2025, slightly down from $88.298 million as of December 31, 2024[28] - Stockholders' equity decreased to $248.707 million as of September 30, 2025, from $280.320 million as of December 31, 2024[28] - Noncurrent liabilities increased to $230.963 million as of September 30, 2025, compared to $225.163 million as of December 31, 2024[28] Clinical and Commercial Developments - Demand for RYTELO decreased by 3% quarter-over-quarter, with approximately 1,150 ordering accounts, an increase of about 150 accounts from the previous quarter[5] - Completed enrollment of 320 patients in the Phase 3 IMpactMF clinical trial in September 2025, with interim analysis expected in the second half of 2026[5] - Announced the appointment of Ahmed ElNawawi as Chief Commercial Officer to enhance commercial execution and drive growth for RYTELO[14] Future Guidance - The company expects total operating expenses for fiscal year 2025 to be between $250 million and $260 million, revised from previous guidance of $270 million to $285 million[12]

Group 1 - The article does not provide any relevant content regarding company or industry insights [1]

Core Viewpoint - The MSCI ESG rating for Geron Corporation (GERN.US) has been downgraded from AA to BBB as of November 4, 2025 [1] Summary by Category - **Company ESG Rating Change** - Geron Corporation's MSCI ESG rating has been reduced from AA to BBB [1]

Core Viewpoint - Bragar Eagel & Squire, P.C. is investigating potential claims against Geron Corporation on behalf of long-term stockholders following a class action complaint filed against Geron, focusing on possible breaches of fiduciary duties by the board of directors [2][3]. Group 1: Legal Investigation - The class action complaint against Geron was filed on March 14, 2025, with a class period from February 28, 2024, to February 25, 2025 [2]. - The investigation centers on whether Geron's board of directors has breached their fiduciary duties to the company [2]. Group 2: Allegations in the Complaint - The complaint alleges that throughout the class period, Geron's executives provided misleading information regarding the launch and growth potential of Rytelo (imetelstat) [3]. - It is claimed that the executives expressed confidence in Geron's ability to meet the significant unmet need for the drug while downplaying risks associated with weekly monitoring requirements and competition [3]. Group 3: Next Steps for Investors - Long-term stockholders of Geron are encouraged to contact Bragar Eagel & Squire for more information regarding the claims and their rights [4]. - The firm offers a no-cost consultation for those interested in discussing their legal options [4]. Group 4: About the Law Firm - Bragar Eagel & Squire, P.C. is a nationally recognized law firm with a focus on representing individual and institutional investors in complex litigation [5]. - The firm operates in multiple states, including New York, South Carolina, and California [5].

Company Overview - Geron Corporation (NASDAQ: GERN) stock is trading near its 52-week lows after experiencing double-digit declines this year [1] - Over the past month, the company has faced mid-single digit losses [1] Analyst Background - Gamu Dave Innocent Pasi is a seasoned financial professional with extensive experience in financial analysis and investment research [1] - He has a strong background in analyzing financial statements, capital markets, and the macro-economy, providing actionable trading ideas and well-researched investment recommendations [1] - His insights have been featured in reputable publications, and he holds a Postgraduate Executive Certificate in Investments and Portfolio Management, along with a Bachelor of Business Studies Honors degree in Banking and Finance [1] Investment Focus - Gamu is focused on building a new international investment portfolio and aims to share insights, strategies, and forward-looking ideas with the global investing community [1] - He is an advocate for Responsible Investment and actively promotes Environmental, Social, and Governance (ESG) principles in investment decision-making [1]

Core Insights - Geron Corporation's stock is trading near its 52-week lows, having experienced a significant decline of double-digit percentages this year [1] - Over the past month, the company has faced mid single-digit losses [1] Company Overview - Geron Corporation is currently under pressure in the market, with its stock performance reflecting broader challenges [1] Analyst Background - Gamu Dave Innocent Pasi, a financial professional with extensive experience in investment research, emphasizes the importance of financial inclusion and sustainability in investment strategies [1] - Pasi has a strong track record in analyzing financial statements and capital markets, contributing to reputable publications [1]

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

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