Four new executives appointed, including new Chief Commercial Officer, to lead commercial strategy and operationsFOSTER CITY, Calif., Oct. 13, 2025 (GLOBE NEWSWIRE) -- Geron Corporation (Nasdaq: GERN), a commercial-stage biopharmaceutical company aiming to change lives by changing the course of blood cancer, today announced several executive transitions and appointments designed to align the company’s leadership structure with its strategic priorities. Andrew Grethlein, Ph.D. who joined Geron in September 2 ...

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

Financial Data and Key Metrics Changes - As of March 31, 2025, the company had approximately $457.5 million in cash and equivalents, down from $502.9 million as of December 31, 2024 [42] - Total net product revenue for Q1 2025 was $39.4 million, a decrease of $8 million from Q4 2024, attributed to inventory drawdown among distributors [7][42] - Research and development expenses for Q1 2025 were $15.1 million, significantly lower than $29.4 million for the same period in 2024, due to reduced clinical trial costs [43] - Selling, general, and administrative expenses increased to $40 million in Q1 2025 from $27.1 million in the same period last year, primarily due to higher personnel expenses [44] Business Line Data and Key Metrics Changes - Q1 sales of Rytello were $39.4 million, with demand relatively flat at a 1% increase compared to the previous thirteen weeks [7] - Approximately 900 sites of care have utilized Rytello, an increase of nearly 300 new sites since the end of Q4 2024 [24] - Demand grew approximately 10% in the four-week period ending April 25, 2025, compared to the prior four-week period, marking the highest month-over-month growth since October 2024 [25] Market Data and Key Metrics Changes - The estimated U.S. total addressable market for Rytello is approximately 15,400 lower-risk MDS patients, with significant opportunities to expand use in earlier lines of treatment [15] - In Europe, the total addressable market for Rytello is estimated to be about 80% of the U.S. market [15] - Approximately 85% of U.S. covered lives are now under favorable Rytello medical coverage policies consistent with FDA labels and NCCN guidelines [26] Company Strategy and Development Direction - The primary corporate priority is the successful U.S. commercialization of Rytello, with a focus on increasing brand awareness and refining marketing efforts [6][10] - The company plans to work with experienced third parties for commercialization outside the U.S. to minimize investment while focusing on U.S. efforts [11] - The late-stage clinical development program aims to expand Imetel for broader use within hematology, potentially doubling the commercial opportunity of Rytello if successful [12][48] Management's Comments on Operating Environment and Future Outlook - Management acknowledged that Q1 sales were modest and do not reflect Rytello's true commercial potential, emphasizing the commitment to making it part of the standard of care for eligible patients [46] - The company is encouraged by early performance indicators and is prepared to make adjustments to improve commercial execution [47] - The pivotal Phase III trial evaluating Imetelstat in relapsed-refractory myelofibrosis is expected to provide interim analysis data in the second half of 2026, which could significantly impact commercial potential [48] Other Important Information - The process to identify a permanent CEO is ongoing, with a decision expected within the next six months [12] - The company is expanding its medical affairs team to enhance community awareness and HCP confidence in prescribing Rytello [29] Q&A Session Summary Question: Expectations for Q2 and year cadence - Management noted that inventory issues are behind them, and they anticipate continued momentum building into Q2 and throughout 2025 [50][53] Question: Commercial efforts to promote switching to Rytello - Management highlighted that awareness and education are key to driving physician perceptions and utilization of Rytello, with positive shifts noted in recent market research [56][60] Question: Inventory dynamics and corrections - Management explained that higher inventory levels were due to several factors, including seasonality and anticipation of pricing issues, but they believe the situation has stabilized [64][66] Question: Reasons for physicians not reordering Rytello - Management indicated that discontinuations are largely reflective of clinical trial data, with no new surprises in market research [87] Question: Demand increase sustainability - Management expressed optimism about sustaining the recent 10% demand increase, attributing it to effective messaging and physician engagement [97]

Financial Data and Key Metrics Changes - As of March 31, 2025, the company had approximately $457.5 million in cash, cash equivalents, restricted cash, and marketable securities, down from $502.9 million as of December 31, 2024 [43] - Total net product revenue for Q1 2025 was $39.4 million, a decrease of $8 million from Q4 2024, attributed to an inventory drawdown among distributors [43][44] - Research and development expenses for Q1 2025 were $15.1 million, compared to $29.4 million for the same period in 2024, primarily due to lower clinical trial costs [44][45] - Selling, general, and administrative expenses increased to $40 million in Q1 2025 from $27.1 million in the same period last year, mainly due to higher personnel expenses [45] Business Line Data and Key Metrics Changes - Q1 Rytello net revenues were $39.4 million, down from Q4, with demand relatively flat at a 1% increase compared to the previous thirteen weeks [6][44] - Approximately 900 sites of care utilized Rytello as of April 2025, an increase of almost 300 new sites since the end of Q4 [24] - Demand grew approximately 10% in the four-week period ending April 25 compared to the prior four-week period, marking the highest month-over-month growth since October 2024 [25] Market Data and Key Metrics Changes - The estimated U.S. total addressable market for Rytello is approximately 15,400 lower-risk MDS patients, with significant opportunities to expand use in earlier lines of treatment [15] - In Europe, the estimated total addressable market for Rytello is approximately 80% of the U.S. market [15] - Approximately 85% of U.S. covered lives are now under favorable Rytello medical coverage policies consistent with FDA label and NCCN guidelines [26] Company Strategy and Development Direction - The company's top priority is the successful commercialization of Rytello in the U.S., with plans to increase brand awareness and refine marketing efforts [5][17] - The company is pursuing a disciplined path for EU commercialization, planning to engage third-party partners to minimize investment while focusing on U.S. efforts [11][28] - The ongoing Phase III trial for Imetelstat in relapsed-refractory myelofibrosis could potentially double the commercial opportunity for Rytello if successful [12][48] Management's Comments on Operating Environment and Future Outlook - Management acknowledged that Q1 sales were modest and do not reflect the product's true commercial potential, emphasizing the commitment to making Rytello part of the standard of care [47] - The company is encouraged by early performance indicators and is ready to make adjustments to improve commercial execution [47] - The interim analysis for the Phase III trial is expected in the second half of 2026, with management optimistic about the potential outcomes [49] Other Important Information - The company is in the process of identifying a permanent CEO, with a decision expected within the next six months [12] - The company plans to maintain financial discipline while investing in the commercialization strategy for Rytello [46] Q&A Session Summary Question: What are the expectations for Q2 given the inventory impacts and demand improvements? - Management noted that inventory issues have been addressed and expects continued momentum into Q2, with new commercial representatives expected to impact later in the year [50][53] Question: Can you comment on commercial efforts to promote switching to Rytello? - Management highlighted that awareness and education are key, with positive shifts in perceptions regarding Rytello's efficacy and cytopenia management among physicians [56][58] Question: What is the current status of inventory levels? - The inventory at the end of Q1 was on the lower end of two to two and a half weeks, indicating a drawdown from the higher levels seen previously [93] Question: Are new patient starts exceeding discontinuations? - Management indicated that while there is no perfect data, new patient starts are promising, with approximately 25% of new starts occurring in the first and second lines of therapy [96] Question: What drove the incremental cash burn in Q1? - The cash burn was higher due to payouts of bonuses and early investments in inventory, typical for Q1 [97]