Geron Corp 2026 Q2 Earnings Call

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 U.S. 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, involve risks and uncertainties that could cause actual events, performance, and results to differ materially from those contained in these forward-looking statements.

I refer you to the risks and uncertainties described in today's earnings release and under the heading Risk Factors in Geron's most recent periodic report filed with the SEC, which identify important factors that could cause actual results to differ materially from those contained in these forward-looking statements and future updates to Geron's risks and uncertainties 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 Geron's progress and strategy.

Thank you, Dawn, 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 continued 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 trial 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 2, 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 Chinmaya Rath as our Chief Business Officer. Chinmaya 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 in the U.S. We expect to share our European commercialization plans before year-end, as previously stated. Turning to our Phase III IMpactMF 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 million-$240 million. We continue to expect total operating expenses for 2026 in the range of $230 million-$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.

Thank you, Harout. We delivered solid RYTELO net revenue growth in the second quarter, marking our third straight quarter of demand growth, and continued to execute on our commercial strategy to build sustainable growth and long-term value. In the second quarter, we achieved 5% demand growth for RYTELO compared to the first quarter of this year, and an 8% increase in prescribing accounts, expanding our footprint to approximately 1,575 accounts since launch. First- and second-line patient starts on a rolling 12-month basis was 34%. These results reflect the steady execution of our refocused commercial strategy. As awareness continues to grow, more appropriate RYTELO patients are being identified earlier in their treatment journey. We believe the second line, lower-risk MDS setting, represents a significant opportunity to bring RYTELO to more patients, where we estimate there to be around 8,000 eligible patients in the U.S.

Our commercial strategy remains focused on initiatives that we believe will drive long-term adoption of RYTELO. We are prioritizing high-volume community treatment centers, identifying appropriate patients earlier in their treatment journey, strengthening account management, and using targeted omnichannel engagement to deliver consistent evidence-based messaging across healthcare professionals' preferred channels. These efforts continue to increase awareness, build HCP confidence in RYTELO, and support its positioning as the standard of care in the second-line setting. In addition to our strategy, strong fundamentals, including RYTELO's broad label, NCCN treatment guidelines, growing real-world evidence, and data from the IMerge trial provide a solid foundation for continued adoption in lower-risk MDS. As physicians' experience and awareness continue to build, we believe we are well-positioned to accelerate demand growth and bring RYTELO to more eligible lower-risk MDS patients. I now turn this over to Joe to discuss our medical and scientific engagement efforts.

Thanks, Nawal. Scientific engagement and evidence generation remain central to how we support HCPs caring for patients with lower-risk MDS. Building on the data presented at ASH 2025, anecdotally, we're seeing a consistent increase in awareness of RYTELO and in meaningful scientific dialogue as physicians continue to incorporate emerging data into clinical practice. There's good understanding of the findings suggesting that treatment-emergent cytopenias are consistent with on-target activity and what those insights may mean for patient management within the approved indication. We're also seeing increased interest from leading academic centers in collaborating through investigator-sponsored studies and real-world evidence initiatives. During the second quarter, this continued dialogue was evident at both ASCO and EHA, where we had the opportunity to share new data and engage directly with the global hematology community.

We were encouraged by the level of interest and the quality of discussions, which reflected growing engagement with RYTELO and our broader investigator-sponsored efforts. At EHA, we presented the first real-world evidence study evaluating RYTELO in patients with lower-risk MDS. The investigator-sponsored study, conducted in collaboration with Moffitt Cancer Center, is a two-part retrospective and prospective study designed to evaluate the safety and clinical efficacy of RYTELO in advanced, heavily transfusion-dependent patients with lower-risk MDS, including patients with extensive prior therapies and after luspatercept failure. The data highlighted at EHA was from the retrospective portion of the study. The findings were encouraging and generally consistent with the phase III IMerge trial, reinforcing the safety, efficacy, and tolerability profile of RYTELO in a broader, real-world patient population.

The data also showed a trend toward optimal management of cytopenias and improved responses when RYTELO was used within the first three lines of therapy.

Real-world evidence is an important complement to clinical trial data, helping us better understand how therapies perform in routine clinical practice. These findings add to the growing body of evidence for supporting the use of RYTELO as a preferred second-line treatment option following prior therapy for lower risk MDS and significant transfusion burden. We expect the prospective portion to provide additional insights, which we look forward to sharing at a future scientific meeting. Beyond our efforts in lower risk MDS, additional presentations at ASCO and EHA highlighted progress across our myelofibrosis program, including an updated overall survival analysis from the phase II IMbark trial compared with real-world data. These findings, together with the totality of evidence generated across our clinical program, continue to support the potential of imetelstat in myelofibrosis and reinforce our confidence in overall survival as the appropriate endpoint for our phase III IMpactMF trial.

It is critical to maintain ongoing dialogue with regulatory authorities when conducting registrational trial. As IMpactMF approaches the one-year anniversary of enrollment completion, we have proactively engaged with the regulatory authorities over the first half of 2026 to ensure the interim analysis can support registration if the DMC recommends unblinding the trial for positive efficacy. As such, we are evaluating a modification to the event threshold for the interim analysis to ensure an appropriate evaluation of imetelstat's benefit/risk profile while we remain blinded to the treatment assignment. At this time, our projected timelines remain unchanged. Our base case remains progression to the final overall survival analysis in the second half of 2028, while an earlier positive outcome at the interim analysis would represent an upside scenario. We will communicate any changes to these projections as appropriate.