8/5/2026

speaker
Operator
Conference Operator

Hello and welcome to the Geron Corporation second quarter 2026 earnings call. At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question and answer session. To ask a question during the session, you will need to press star 11 on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question, please press star 11 again. Please be advised that today's conference is being recorded. I would now like to turn the call over to Dawn Schottland, SVP, Investor Relations and Corporate Affairs.

speaker
Dawn Schottland
SVP, Investor Relations and Corporate Affairs

Good morning, everyone. Welcome to the Geron Corporation second quarter of 2026 earnings conference call. Before we begin, please note that during the course of this presentation and question and answer session, we will be making forward-looking statements regarding future events, performance, plans, expectations, and other projections, including those related to our 2026 financial guidance, our current Rytelo commercialization strategy and related opportunities in the US and the EU, the therapeutic potential of Rytelo, other anticipated clinical and commercial events and related timelines, the sufficiency of our financial resources, and other statements that are not historical fact, which of course involves risks and uncertainties that could cause actual events Thank you for joining us. and Uncertainty Disclosures, including in its upcoming quarterly report on Form 10-Q. Geron undertakes no duty or obligation to update its forward-looking statements. Joining me on today's call are several members of Geron's management team. Harout Semerjian, Chief Executive Officer, Ahmed ElNawawi, our Chief Commercial Officer, Dr. Joseph Eid, Executive Vice President of Research and Development and Chief Medical Officer, and Michelle Robertson, our Chief Financial Officer. With that, I'll turn the call over to Harout to discuss Jeroen's progress and strategy.

speaker
Harout Semerjian
Chief Executive Officer

Thank you Dawn and good morning everyone. Our second quarter results demonstrate the continued progress we are making and the momentum we are building as we execute our strategy outlined at the beginning of the year. We delivered another quarter of net revenue growth expanding Rytelo's reach to more eligible patients, strengthened the clinical evidence supporting Rytelo, continued investing in future growth opportunities, all while remaining financially disciplined. Let me start with our commercial performance. Second quarter net revenue increased 17% year over year and 11% quarter over quarter to $57.5 million. Through the first half of 2026, net revenue grew by approximately 24% compared to the same period a year ago, demonstrating sales momentum as our refocused commercial strategy gains traction. During the quarter, we continue to expand awareness and education among healthcare professionals with a focus on identifying appropriate second line patients. At EHA, We presented the first real-world evidence study of Rytelo in low-risk MDS with findings that were generally consistent with results from our Phase III iMERGE trials and further validated Rytelo's profile in a broader patient population. As for operating expenses, we continued to make prudent investment decisions while delivering top-line growth. In the first half of 2026, Our total operating expenses decreased by 4% compared to the same period a year ago, while net revenue increased 24%. With $327 million of cash on hand at the end of quarter two, our balance sheet is strong and provides us with the flexibility to continue investing in our commercial business, advance our science, and evaluate opportunistic innovation. As part of that strategy, We recently welcomed Tumaya Rast as our Chief Business Officer. Tumaya brings deep business development experience and a proven track record of identifying and executing strategic growth opportunities. His appointment reflects our commitment to maximizing the value of our current portfolio and building a leading hematology company. Beyond our U.S. focus, We recognize the significant unmet need for patients with low-risk MDS in Europe and beyond and are exploring gated commercial strategies to bring Rytelo to appropriate patients while maintaining pricing integrity and regress. We expect to share our European commercialization plans before year-end, as previously stated. Turning to our Phase III IMPACT-MS trial in relapsed refractory myelofibrosis, Over the first half of 2026, we have proactively engaged with regulatory authorities and external experts to ensure the interim analysis design is adequate to support registration should the DMC recommend unblinding for positive efficacy. As such, we're evaluating a modification to the event threshold for the interim analysis. At this time, our projected timelines remain unchanged, We will communicate any changes to these projections as appropriate. As we look to the second half of the year, we remain focused on executing across each of our strategic priorities, including growing Rytelo demand. Based on our solid net revenue performance in the first half of the year, we anticipate coming in at the mid to high end of our full year 2026 Rytelo net product revenue guidance range of 220 to $240 million. We continue to expect total operating expenses for 2026 in the range of $230 to $240 million. We're confident in our team, strategy, and operating model and encouraged by the momentum we have generated through the first half of the year. Most importantly, we're committed to reaching more eligible patients with low-risk MDS and making a meaningful difference in their lives. With that, I'll turn it over to Nawawi to provide more detail on Rytelo's commercial performance and our execution.

Disclaimer

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