Geron Corporation Q2 2026 Earnings Call - RYTELO Revenue Grows 17% as Geron Targets Mid-to-High Full-Year Guidance

Operator: Hello, 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 Schottlandt, SVP, Investor Relations and Corporate Affairs.

Dawn Schottlandt, SVP, Investor Relations and Corporate Affairs, Geron Corporation: 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.

Harout Semerjian, Chief Executive Officer, Geron Corporation: 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.

Ahmed ElNawawi, Chief Commercial Officer, Geron Corporation: 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.

Dr. Joseph Eid, Executive Vice President of Research and Development and Chief Medical Officer, Geron Corporation: 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.

Harout Semerjian, Chief Executive Officer, Geron Corporation: 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.

Dr. Joseph Eid, Executive Vice President of Research and Development and Chief Medical Officer, Geron Corporation: 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.

As a final note, the upcoming fall congress season, including SOHO and ASH, will provide additional opportunities to share data, engage with the hematology community, and continue building on the scientific momentum we’ve established this year. I’ll now hand it over to Michelle to walk through financials.

Michelle Robertson, Chief Financial Officer, Geron Corporation: Thank you, Joe, and good morning, everyone. For more detailed results from the second quarter, please refer to the press release we issued this morning, which is available on our website. Our first half financial results, including 24% net revenue growth compared to the same period in 2025, along with a 4% decrease in total operating expenses compared to the same period in 2025, underscore the progress we are making on our operational execution while maintaining financial discipline. We are in a strong financial position and have the resources to deliver on our 2026 financial guidance while advancing the strategic priorities that will drive durable value creation for both patients and our shareholders. In the second quarter, total net revenue for the three months ended June 30, 2026 was $57.5 million, compared to $49 million in Q2 2025.

Gross to net deductions increased to 20.7% for the three months ended June 30th, 2026, compared to 15.3% for the same period in 2025. For the remainder of 2026, we continue to expect gross to net to be in the low to mid-twenties. Research and development expenses for the three months ended June 30th, 2026 were $22 million, compared to $21.7 million in expenses for the same period in 2025. The increase in research and development expenses was a result of investments in CMC and was partially offset by lower headcount costs from the workforce reduction in December 2025. For 2026, we expect continued investment in CMC and in our clinical development programs, with lower employee costs driven by the decrease in headcount as a result of the workforce reduction in 2025.

Selling, general, and administrative expenses for the three months ended June 30th, 2026 were $38.9 million, compared to $38.6 million for the same period in 2025. This change was primarily due to higher marketing expenses, partially offset by lower general and administrative personnel-related expenses as a result of the workforce reduction in December 2025. For 2026, we expect continued investment in our RYTELO commercialization strategy and flat G&A spend. Total operating expenses, excluding cost of goods sold for the three months ended June 30th, 2026, were $60.7 million, compared to $60.3 million for the same period in 2025. Continued investments in commercial strategy and CMC were partially offset by lower headcount costs from the workforce reduction in December 2025.

As of June 30th, 2026, we had approximately $327 million in cash equivalents, restricted cash, and marketable securities, compared to $341 million as of March 31st, 2026. We are committed to maintaining our financial discipline and are well positioned to fund growth from our current operations. Based on our solid performance and execution to date, we expect to come in at the mid to high end of our 2026 RYTELO net revenue guidance of $220 million-$240 million, reflecting consistent quarter-over-quarter net revenue growth throughout the year. Our total operating expense guidance of $230 million-$240 million reflects investment to accelerate RYTELO growth while maintaining operating expense discipline. We are well capitalized and on track to deliver on our strategic and financial priorities for the year.

With that, I’ll turn the call back to Harout for closing remarks.

Harout Semerjian, Chief Executive Officer, Geron Corporation: Thanks, Michelle. As you’ve heard today, we’ve made meaningful progress through the first half of the year in advancing the strategy we outlined at the beginning of 2026. With a patient-focused and performance-driven Geron team, we are poised to deliver strong commercial execution, continued scientific engagement, and disciplined financial management. We’re entering the second half of 2026 with confidence in our strategy, our team, and the opportunities ahead. The focus is on expanding RYTELO’s reach to more eligible patients in the U.S., expanding access to RYTELO in other geographies, advancing our phase III IMpactMF program, and evaluating opportunistic innovation that supports our long-term vision of building Geron into a leading hematology company. Operator, we’re now ready to start the Q&A session.

Operator: Thank you. As a reminder, to ask a question, please press star one one on your telephone and wait for your name to be announced. To withdraw your question, please press star one one again. Please stand by while we compile the Q&A roster. Our first question comes from Tara Bancroft of TD Cowen. Your line is open.

Tara Bancroft, Analyst, TD Cowen: Hi, good morning. It’s a great quarter. Really happy to see it. I guess, my question is, going forward, looking back on last year, it looked like seasonality. It did coincide with some major changes that you guys had at the company that you mentioned. I’m curious if you have any thoughts on how seasonality may impact the rest of this year, but potentially be offset by these efforts that you’ve got into inflecting in the back half of the year. Thanks so much.

Harout Semerjian, Chief Executive Officer, Geron Corporation: Thank you, Tara, and good to hear from you. We are very excited about this quarter, obviously. $57.5 million of net revenue sales, 17% growth year-over-year, 11% growth quarter-over-quarter. It’s something that, as a team, we’re very happy about. Of course, seasonality and other things have played a role, we really don’t see that. Our finance teams, the commercial teams have really been very disciplined in terms of how we can anticipate some of these things. Maybe, Michelle, if you want to tackle some of that question, that would be great.

Michelle Robertson, Chief Financial Officer, Geron Corporation: Yeah. Tara, we continue to manage our inventory within our range of two to four weeks. As I’ve guided that, we’re very comfortable with a gross to net projection in low to mid-20s. We don’t expect any significant spikes or decreases in the back half of the year. As Harout mentioned, we’re looking for consistent growth quarter-over-quarter, we expect to be on the higher end of our revenue guidance.

Tara Bancroft, Analyst, TD Cowen: Wonderful. Okay. Thank you, guys.

Harout Semerjian, Chief Executive Officer, Geron Corporation: Thank you.

Operator: Thank you. Our next question comes from Emily Bodnar of H.C. Wainwright. Your line is open.

Emily Bodnar, Analyst, H.C. Wainwright: Hi. Good morning. Thanks for taking the questions. Congrats on the quarter as well. Maybe as you’re kind of growing your ordering accounts for RYTELO, are you seeing increased reordering from existing accounts, or is growth kind of mainly coming from the new accounts? Secondly, as you’re kind of seeing more of an increase into first-line, second-line patients compared to third-line patients, are you also seeing an increase in persistence and time on therapy with that as well? Thank you.

Harout Semerjian, Chief Executive Officer, Geron Corporation: Yeah. Thank you, Emily. I’ll open it up, and then I’ll hand it to Nawal for additional color. Our growth is really coming from both. One of the things which we’re quite happy about is our growth is now predominantly driven by the community accounts, which is really where the further growth will happen and the further penetration would happen. Nawal, do you want to give some additional color on that?

Ahmed ElNawawi, Chief Commercial Officer, Geron Corporation: Yeah. Thank you, Emily, for the question. The growth is coming from both, as Harut mentioned. We do expect, as our strategy continues to be executed successfully, that the breadth will be playing a smaller component in the second half of the year, and the depth is becoming a more focused metric that we are focused on. It was very encouraging to see that the community accounts, especially the high-tier community accounts, are responding well to our messages, and that is playing a bigger role in our book of business. Duration of therapy is something that we really don’t have a good metric to track. We don’t see it either going up or down because we don’t really have a decent denominator, if you will, that allows us to measure that.

Harout Semerjian, Chief Executive Officer, Geron Corporation: Thank you, Nawal.

Emily Bodnar, Analyst, H.C. Wainwright: Thank you.

Operator: Thank you. As a reminder, if you have a question, please press star one one. Our next question comes from Stephen Willey of Stifel. Your line is open.

Stephen Willey, Analyst, Stifel: Good morning. Thanks for taking the questions, and congrats on the progress. It sounds like you are in discussion with FDA around potentially modifying the event threshold for the interim. Just curious if there’s been any contemplation of altering the threshold for the final OS analysis as well. Thanks.

Harout Semerjian, Chief Executive Officer, Geron Corporation: Thanks, Steve. Thanks for the question. Maybe a couple of words from me before turning it to Joe. We’ve always maintained that from our planning purposes, we think that these trials, which are overall survival primary endpoint, need time to mature. That’s why our base planning is always for it to go the full length. With the caveat that there is an interim analysis that is built into the trial design, which is very appropriate in our opinion. We want to make sure that those interims are very well and consistent with the regulators, given that these trials have taken many, many years to be fully enrolled. That’s why we are having those conversations on the interim.

It doesn’t change the design of the trial, that’s one where we’re engaging with the regulators at this point, predominantly around the interim rather than the full design of the trial. We do believe the trial is a very appropriate trial for a patient population and for what we’re trying to show over here. Joe, anything else you want to add?

Dr. Joseph Eid, Executive Vice President of Research and Development and Chief Medical Officer, Geron Corporation: Yeah, we’re making sure that there’s alignment on the interim analysis, whether it’s the threshold, given that the trial started in the early 2020s and FDA changes, standard of care changes, that’s appropriate. As far as the final analysis, the OS primary endpoint as well as the timing are not changing.

Stephen Willey, Analyst, Stifel: All right, thanks for taking the question.

Operator: Thank you. As a reminder, if you do have a question, please press star one one. One moment for our next question. Our next question comes from Gil Blum of Needham. Your line is open.

Jonathan (Gil Blum’s colleague), Analyst, Needham: Hey, guys. Congrats on the quarter. This is Jonathan on for Gil. Just a quick question here around the EU commercial strategy. I know you guys mentioned that you guys are thinking about pricing dynamics, obviously, as you think about a potential EU strategy. I just wanted to clarify that with MFN concerns, this would mean countries that don’t have visible net prices. Just wanted to see if potential paths forward include potential partnerships. Thanks.

Harout Semerjian, Chief Executive Officer, Geron Corporation: Thank you, Jonathan, for the two questions. Yeah, look, our vision is to have RYTELO help as many patients as possible in the U.S. and ex-U.S. As we have mentioned before, we believe there is as much opportunity in terms of patient numbers in Europe as there is in the U.S., and that is in the thousands. That is something which we want to actively pursue and see what are the optimal ways of helping those patients. As you know, predominantly, our trials have actually been conducted in Europe, so there is a lot of advocacy, a lot of medical experts who have hands-on experience in Europe, and we’re engaging with them. We’re engaging with the payers as well. We understand the MFN dynamic, and that’s something we’re monitoring it very closely. The MFN itself is actually evolving as well.

We’re waiting for more updates on the GLOBE and GUARD Models, and once we have those, we’ll have a further look into that. The fact remains that there are thousands of patients who can really help, and that’s why we’ve said we want to actively pursue a strategy in Europe. It can include or exclude partnership conversations as well, Jonathan. I think in the world of MFN, everybody’s learning how to launch therapies and bring it to more patients outside. We believe that this is one where, given that the rules are evolving, we believe that we can have those conversations and come up with an update to the market back before end of the year, as we previously mentioned, on what would be an optimized strategy ex-U.S. in particular Europe, in particular some of the major countries like Germany and France. Does that answer your question?

Jonathan (Gil Blum’s colleague), Analyst, Needham: Yeah, appreciate it. Thank you.

Harout Semerjian, Chief Executive Officer, Geron Corporation: Thank you.

Operator: Thank you. I show no further questions at this time. I’d like to turn it back to Harout Semerjian for closing remarks.

Harout Semerjian, Chief Executive Officer, Geron Corporation: Thank you everyone for joining our call today. We look forward to updating you on our progress in the next quarters, and I’m sure we’re going to have a lot of one-on-ones as well. Looking forward to that. Thank you.

Operator: This concludes today’s conference call. Thank you for participating, and you may now disconnect.