Geron Corp (GERN) Q2 2026 Earnings Call Transcript

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 Chotlin, SVP, Investor Relations and Corporate Affairs.

Good morning, everyone. Welcome to the Joe Run 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 Ritello commercialization strategy and related opportunities in the U.S. and the EU, the therapeutic potential of Ritello, other anticipated clinical and commercial events and related timelines, the sufficiency of our financial resources, and other statements that are not historical fact, fact, which of course involves risk and uncertainties that could cause actual events, performance, and results to differ materially from those contained in these forward-looking statements. Therefore, I refer you to the risk and uncertainties described in today's earnings release, another of the having risk factors in Jaron'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 feature updates to Jaron's risk and uncertainty disclosures, including in his upcoming quarterly report on Form 10-Q. Jaron undertakes no duty or obligation to update its forward-looking statements. Joining me on today's call are several members of Jaron's management team. Perut Samarjian, Chief Executive Officer, Ahmed El-Nawawi, 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 Nicole over to Harut to discuss Geron's progress and strategy.

Thank you, Don, 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 Ritello's reach to more eligible patients, strengthened the clinical evidence supporting Ritello, 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 percent quarter-over-quarter to $57.5 million. Through the first half of 2026, net revenue grew by approximately 24 percent 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 Ritello in low-risk MDS with findings that were generally consistent with results from our Phase III iMERGE trial and further validated Ritello's profile in a broader patient population. As for operating expenses, we continue 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 dollars 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 welcome Chumaya Raas as our Chief Business Officer. Chumaya 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 Ritello 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 3 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 Ritalo 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 Ritello net product revenue guidance range of 220 to 240 million dollars. We continue to expect total operating expenses for 2026 in the range of 230 to 240 million dollars. 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 Ritello's commercial performance and our execution.

Thank you, Harut. We delivered solid Ritello 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 Ritello compared to the first quarter of this year and an 8% increase in prescribing accounts, expanding our footprint to approximately 1575 accounts since launch first and second line patient starts on a rolling 12-month basis was 34 percent these results reflect the steady execution of our refocused commercial strategy as awareness continues to grow more appropriate tritello patients are being identified earlier in their treatment journey we believe the second line lower risk mds setting represents a significant opportunity to bring ritello 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 ritello We are prioritizing high-volume community treatment centers, identifying appropriate patients earlier in their treatment journey, strengthening account management, and using targeted omni-channel engagement to deliver consistent evidence-based messaging across healthcare professionals' preferred channels. These efforts continue to increase awareness, build HCP confidence in Ritello, and support its positioning as the standard of care in the second-line setting. In addition to our strategy, strong fundamentals, including Ritello's broad label, NCCN treatment guidelines, growing real-world evidence, and data from the iMERGE trial provide a solid foundation for continued adoption in low-risk MDS. As physicians' experience and awareness continue to build, we believe we are well-positioned to accelerate demand growth and bring Ritello for more eligible, lower-risk MDS patients. I now turn this over to Joe to discuss our medical and scientific engagement efforts.

Thanks, Nawawi. 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 Ritello and in meaningful scientific dialogue as physicians continue to incorporate emerging data into clinical practice. There is 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 indications. 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 Wytelo and our broader investigator-sponsored efforts. At EHA, we presented the first real-world evidence study evaluating Wytelo in patients with lower-risk MDS. The investigator-sponsored study, conducted in collaboration with Mossett Cancer Center, is a two-part retrospective and prospective study designed to evaluate the safety and clinical efficacy of Vitello in advanced, heavily transfusion-dependent patients with low-risk MDS, including patients with extensive prior therapies and after luspatocet failure. The data highlighted at EHA was from the retrospective portion of the study. The findings were encouraging and generally consistent with phase III iMERGE trial, reinforcing the safety, efficacy, and tolerability profile of Ritello in a broader real-world patient population. The data also showed a trend toward optimal management of cytopenias and improved responses when Ritello 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 EMBARC 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 IMITEL-STAT in myelofibrosis and reinforce our confidence in overall survival as the appropriate endpoint for our Phase III IMPACT-MF trial. It is critical to maintain ongoing dialogue with regulatory authorities when conducting registrational trials. And as IMPACT-MF 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 the METEL staff'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. it. 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.

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 four percent 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 30th 2026 was 57.5 million compared to 49 million in q2 2025. growth to net deductions increased to 20.7 percent for the three months ended June 30th, 2026, compared to 15.3 percent 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-20s. 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 were the results of investments in CMC and was partially offset by lower head count costs from the workforce reduction in December of 2025. For 2026, we expect continued investment in CMC and in our clinical development programs with lower employee costs driven by the decrease in head count 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 Ritello 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 dollars in cash 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 Ritello net revenue guidance of $220 million to $240 million, reflecting consistent quarter-over-quarter net revenue growth throughout the year. Our total operating expense guidance of $230 million to $240 million reflects investment to accelerate Ritello 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 Harut for closing remarks.

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 Ritella and other geographies, advancing our Phase III Impact MF 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.

Thank you. As a reminder, to ask a question, please press star 11 on your telephone and wait for your name to be announced. To withdraw your question, please press star 11 again. Please stand by while we compile the Q&A roster. And our first question comes from Tara Bancroft of TD Cal and your line is open. Hi, good morning. It's a great quarter, really happy to see it. So I guess, you know, my question is going forward, you know, 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 so 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 thank you Tara and good to hear from you yeah we are very excited about this quarter obviously 57.5 million dollars of net revenue sales, 17% growth year-over-year, 11% growth quarter-over-quarter is something

that, you know, as a team, we're very happy about. Of course, seasonality and other things have played a role, but we really don't see that.

You know, our finance teams, the commercial teams have been very disciplined in terms of how we can anticipate some of these things, but maybe, Michelle, if you want to tackle tackle some of that question though that would be great yeah I mean Tara we continue to manage our inventory within our range of two to four weeks and as I've guided that we're very comfortable with a gross to net projection and low to mid 20s so we don't expect any significant spikes or decreases in the back half of the year as her room mentioned we're looking for consistent growth quarter over quarter and we expect to be on the higher end of our revenue

guys wonderful okay thank you guys thank you thank you and our next question comes from emily bodner of hc wainwright your line is open hi good morning thanks for sharing the questions and congrats on the quarter as well um maybe as you're kind of growing your ordering accounts for writelo are you seeing increased reordering from existing accounts or is growth kind of mainly coming from the new accounts and then 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 yeah thank you emily i'll i'll open it up and then i'll hand it to nawawi for additional color um our growth is is really coming from from 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, you know, the further growth will happen and the further penetration would happen. But Noah, would you want to give some additional color on that?

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, and 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 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. Thank you, Noah.

Thank you. Thank you. And as a reminder, if you have a question, please press star 11. And our next question comes from Stephen Willey of Stifel. Your line is open.

Yeah, good morning. Thanks for taking the questions and congrats on the progress. So, 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.

Thanks, Steve, and thanks for the question. Maybe a couple of words from me before turning it to Joe. So, you know, we've always maintained that our, you know, 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, And 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. So that's why we are having those conversations on the interim. It doesn't change the design of the trial, but that's one where, you know, 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?

Yeah, I mean, we're making sure that there's alignment on the interim analysis, whether it's the threshold, you know, given that the trial, you know, started in the early 2020s and FDA changes, standard of care changes. So, that's, you know, appropriate. As far as the final analysis, you know, the OS primary endpoint as well as the timing, you know, are not changing.

All right. Thanks for taking the question.

Thank you. And as a reminder, if you do have a question, please press star 11. One moment for our next question. And our next question comes from Gil Blum of Needham. Your line is open.

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. Also, just wanted to see if potential paths forward continue, or sorry, potential paths forward include potential partnerships.

Thank you, Johnson, for the question, for the two questions. Yeah, look, I mean, our vision is to have Ritello 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. So 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 um the mfn itself is actually you know evolving as well we're we're waiting uh for more updates um uh you know on on the global guard models and once we have those we'll have a you know more uh you know further look into that but the fact remains that there are thousands of patients who can really help and that's why we've said we want to, you know, actively pursue a strategy in Europe, and it can include or exclude partnership conversations as well, Jonathan. I think in the world of MFN, everybody's learning how to, you know, launch therapies and bring it to more patients outside, so 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-US, in particular Europe, in particular some of the major countries like Germany and France. Does that answer your question?

Yeah, I appreciate it. Thank you.

Thank you.

Thank you. I've shown no further questions at this time. I'd like to turn it back to Harut Simerjian for closing remarks.

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, so looking forward to that. Thank you.

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