Geron Corporation (GERN) Q1 2026 Earnings Report, Transcript and Summary

Hello, and welcome to Geron Corporation First Quarter 2026 Earnings Call. [Operator Instructions] Please be advised that today's conference is being recorded. I would now like to turn the call over to Dawn Schottlandt, Senior Vice President, Investor Relations and Corporate Affairs. You may begin.

Good morning, everyone. Welcome to the Geron Corporation First Quarter 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 relating 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 facts, 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. Therefore, 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 risk 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 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 review Geron's progress and strategy.

Thank you, Dawn, and good morning, everyone. In the first quarter, we made progress on our 2026 strategic priorities. We grew RYTELO through focused commercial execution and advanced our European commercial and pricing strategy while maintaining our financial discipline. We also further strengthened our leadership team by welcoming Timothy Williams, our new Chief Legal Officer and Corporate Secretary for Geron, along with 2 new Board members, Patricia Andrews and Constantine Chinoporos. Collectively, they bring decades of experience leading and advising biopharmaceutical company and will be instrumental as we execute on our strategic priorities and drive commercial growth for RYTELO. RYTELO first quarter net revenue was $51.8 million, an increase of 31% year-over-year and 8% quarter-over-quarter, placing us on track to achieve our 2026 net revenue guidance of $220 million to $240 million. We continue to see strong tailwinds in the treatment landscape complementing our refocused commercial strategy and driving RYTELO demand. We are focused on 3 key initiatives fueling our RYTELO U.S. growth strategy. On the commercial side, we're continuing to increase awareness and education for RYTELO amongst U.S. health care professionals with a refined engagement plan to help identify appropriate second-line patients faster, and complementing our field force efforts by increasing our in-person and digital presence across hematology forums through accelerated investment in our surround sound approach. From a medical affairs perspective, we are expanding our research partnerships and investigator-sponsored trial programs with the U.S. hematology community to increase our knowledge and real-world experience with RYTELO. Growing RYTELO demand in the U.S. market remains our priority. And we know from patients at HCP, there is an unmet need for low-risk MDS treatment options in Europe and an interest in RYTELO to help address that need. This quarter, we engaged in conversations with European medical experts, made progress with health technology assessment and conducted detailed research to better understand the European pricing environment. As a biotech company, we have an obligation to make our medicines available to patients, but we also have a responsibility to maintain a value that reflects our innovation and support our next wave of growth. We know the demand in Europe for RYTELO is real, and we are exploring an agent commercial strategy that could maximize RYTELO's value in Europe while maintaining its pricing integrity in the U.S. We expect to communicate our commercial plans for Europe before the end of the year once we have clarity on pricing and market opportunity. Financial discipline remains another top priority for Geron. We reported total operating expenses for the first quarter of [ $50.4 million ], down about 9% year-over-year, a testament to our financial discipline. A few first quarter dynamics such as annual bonus, severance from last year's restructuring and CMC investments to strengthen our supply chain for RYTELO led to a decrease in cash, which was in line with our expectations. We are on track to achieve our 2026 total operating expenses of $230 million to $240 million. With that, I'll turn it over to Nawawi to provide more detail on RYTELO's commercial performance and execution.

Thank you, Harout. RYTELO's first quarter performance was incredible. Our strategy is built to support sustainable growth and ensure RYTELO reaches more eligible patients at the right point in their treatment journey when they are most likely to benefit. In the first quarter, we were able to grow demand 6% quarter-over-quarter and approximately 12% increase in prescribing accounts, expanding our footprint since launch to approximately 1,450 accounts. First and second-line patient starts on a rolling 12-month basis was 33%. RYTELO has the potential to make the biggest impact for lower-risk MDS patients in the second-line setting, which we currently estimate to be approximately 8,000 patients in the U.S. This patient segment is our primary commercial focus and our strategy is supported by the current NCCN guideline. The movement of luspatercept into the first-line setting, backed by RYTELO's broad label and growing real-world experience. And last but not least, the IMerge data, including the data presented at ASH 2025, suggesting treatment-emergent cytopenias are consistent with on-target activity. Our commercial execution is focused on 3 core initiatives. First, targeted engagement with high-volume community accounts. We are prioritizing centers that treat earlier line and second-line patients with our field engagements. Additionally, we continue to engage with lower volume accounts for those privately seeking salvage patients through digital tactics. Second, we are investing in the most effective marketing channels. This includes a strong emphasis on digital non-personal promotion and third-party educational platforms to create what we describe as 3D surround sound for RYTELO, ensuring consistent, high-quality messaging across multiple touch points. Third, we are executing cross-function through effective account management, leveraging data presented at ASH 2025 to proactively address the cytopenias and highlight the potential association with response while positioning RYTELO as the standard of care in appropriate second-line patients regardless of their RS. We believe our commercial strategy and investments are well aligned to bring RYTELO to eligible lower-risk MDS patients in the U.S. and position us to grow demand in 2026. I now turn it over to Joe to discuss our Medicaid and scientific engagement.

Thanks, Nawawi. In the first quarter, we continue to engage closely with the hematology community to increase RYTELO's share of voice. Since the start of the year, we've had a presence at several medical meetings, including the Aplastic Anemia and MDS International Foundation, ASCO, and the 2026 Pan-Hematology Clinical Updates meeting. These are targeted peer-to-peer conferences that provide the opportunity for more detailed clinical dialogue and practical discussion among healthcare professionals. We are also looking forward to attending ASCO and EHA, where we will engage with hematologists to articulate the clear differentiation of imetelstat in low-risk MDS based on clinical efficacy, quality of life benefit and mechanism of action, generate advocacy within the KOL community and support investigator interest in research opportunities aligned with our medical strategy. These medical meetings enable us to further educate the hematology community on RYTELO's deep body of scientific evidence. Our messaging continues to be focused on the ASH 2025 data suggesting treatment-emergent cytopenias are consistent with off-target activity. We are seeing increasing interest from community hematologists understanding these data and learning how to incorporate these insights into their clinical practice. We were pleased to further reinforce the significance of these data with our recent publication in Blood Cancer Journal that examined the association between treatment-emergent cytopenia and clinical responses to RYTELO. We are also engaging with academic centers to support the high interest in imetelstat to advance ISTs and real-world evidence studies. Notably, we are seeing increased interest from centers in Europe wanting to contribute to preclinical, clinical and real-world evidence data generation. We expect initial real-world evidence data to be available in the second half of 2026. In addition, we are pleased to have achieved the inclusion of imetelstat in the National Comprehensive Cancer Network or NCCN, chemotherapy order template. This inclusion positions imetelstat as an active therapeutic versus supportive care for lower-risk MDS. The order template provide healthcare practitioners with clear guidance on administration, enabling imetelstat to be seamlessly incorporated into oncology practice workflows and supporting standardized and appropriate administration across treatment centers. This follows the NCCN guideline update in September 2025, recommending imetelstat as the preferred second-line treatment option in lower-risk MDS. Turning to our Phase III IMpactMF trial in relapsed/refractory myelofibrosis. The fully enrolled trial is projected at this time to reach the interim analysis death event triggered in the second half of this year. Imetelstat works on the foundation of the disease, which is why we believe it has the potential to be a first-in-class therapy in myelofibrosis. In myelofibrosis clinical trial conducted with imetelstat, we saw evidence of disease-modifying activity correlating with clinical benefit and overall survival through a reduction in mutation burden, specifically JAK2, CALR and MPL driver mutation. An improvement in bone marrow fibrosis and reduced telomerase activity, which is important as telomerase is significantly upregulated in cancers. For our IMpactMF trial, overall survival is the primary endpoint, and our confidence in this endpoint is supported by encouraging survival outcomes observed in the Phase II EMBARK trial, which informed the design of the IMpactMF trial. While our base case from a planning perspective remains progression to the final analysis in the second half of 2028, reaching the interim analysis represents an important milestone as we continue to advance the potential beyond lower-risk MDS. An earlier positive outcome would represent an upside scenario to our plan. I'll now hand it over to Michelle to walk through the financials.

Thank you, Joe, and good morning, everyone. For more detailed results from the first quarter, please refer to the press release we issued this morning, which is available on our website. Our first quarter 2026 results reflect our dedication to commercial execution and financial discipline which positions us well to achieve our 2026 financial guidance and advance our strategic priorities to create long-term value for patients and shareholders. In the first quarter, total net revenue for the 3 months ended March 31, 2026, was $51.8 million compared to $39.6 million in Q1 2025. Gross to net reductions increased to 21% for the 3 months ended March 31, 2026, compared to 13% for the same period last year. As volume increased, there was wider 340B utilization and expanded GPO contracting, which we foresee continuing as the business matures. For the remainder of 2026, we expect gross to net to be in the low to mid-20s. Research and development expenses for the 3 months ended March 31, 2026, were $15 million, consistent with $15.1 million in expenses for the same period in 2025. For 2026, we expect continued investment in CMC and our clinical development program and lower employee costs driven by the decrease in headcount as a result of the workforce reduction in December 2025. Selling, general and administrative expenses for the 3 months ended March 31, 2026, were $35.4 million compared to $40 million for the same period in 2025. This change was primarily due to lower general and administrative personnel-related expenses and decreased headcount, partially offset by additional investment in marketing programs. For 2026, we expect continued investment in our RYTELO commercialization strategy and lower G&A personnel-related expenses driven by a decrease in headcount as a result of the workforce reduction in 2025. Total operating expenses excluding cost of goods sold for the 3 months ended March 31, 2026, were $50.4 million compared to $55.1 million for the same period in 2025. The reduction is primarily related to decreased headcount as a result of the workforce reduction in December 2025. As of March 31, 2026, we had approximately $341 million of cash, cash equivalents, restricted cash and marketable securities compared to $401 million as of December 31, 2025. As a reminder, in the first quarter, we typically see a larger cash outflow due to the timing of annual bonus payouts. In addition, severance related to the strategic restructuring we announced in December 2025 was paid out in cash in the first quarter. The decrease in our cash also reflects CMC investments to strengthen our supply chain for RYTELO. We are reiterating our 2026 financial guidance. We expect RYTELO net revenue of $220 million to $240 million with a greater portion of growth anticipated in the back half of the year. Our total operating expense guidance of $230 million to $240 million reflects strong financial discipline and investment to support our commercial strategy. We are in a strong financial position and are on track to achieve our 2026 financial guidance as we execute on our strategic priorities to grow RYTELO while maintaining financial discipline. With that, I'll turn the call back to Harout for closing remarks.

Thanks, Michelle. We continue to build a patient-focused performance-driven culture at Geron, marked by a high level of cross-functional collaboration. Last month, we hosted our first all company national meeting, which was a great opportunity to bring this energized group together and rally around the mission, values and goals that drive us. We have the right team in place to execute on our strategic priorities, bring RYTELO to eligible patients and achieve our 2026 financial guidance. For the remainder of 2026, we are focused on growing RYTELO in the U.S., pursuing pathways to bring RYTELO to patients outside the U.S., advancing our IMpactMF trial, remaining financially disciplined and evaluating opportunistic innovation as we build Geron into a leading hematology company. Thank you again for your time and interest in Geron. Operator, we're now ready to start the Q&A session.

[Operator Instructions] Your first question comes from the line of Tara Bancroft of TD Cowen.

So I have a question on MF. So I know we've been hearing this theme that physicians are very data sensitive in terms of awareness. So I was wondering if you had any updated thoughts on how you'll communicate the MF interim analysis this year. Like would you consider giving any numbers in that release at all? And then with that, I'm also wondering if you think that the interim outcome could have any read-through to potential uptake of RYTELO in MDS.

[ IMpactMF trial ] as you know, is fully enrolled, and we do project that we will do our interim analysis in the back half of this year. So that's still on track. Typically these thing, Tara, you know, the DMC would meet and obviously, we're blinded and we continue to want to stay blinded, depending on the outcomes obviously. But the highest likelihood, at least from a planning perspective, we see is that they tell us keep on going. And if they tell us anything else, then all the material, obviously, that we would communicate to the market accordingly. But Joe, do you want to add anything more?

Yes. Tara, I think your question is how do physicians react to it. The second is disease or indication where you do have a proof of concept and an overall survival impact. So it definitely will have an effect, a positive effect because our message at MDS is that this is a disease-modifying agent, and having this proof of concept in Phase III with overall survival from an MF would definitely enhance and augment that awareness and that value [indiscernible] hematology.

And our next question comes from the line of Gil Blum of Needham & Company.

Congrats on the progress. Just a quick one for us. As it relates to European markets, you guys said you may have conducted some market research. Just sounding -- listening to your messaging, it kind of sounds like you're considering moving forward on your own. Is this fair? Or is this still a question mark?

Gil, yes, in line with what we have said is we want to explore all options to bring RYTELO to patients in Europe. As you know, the European opportunity from a patient numbers perspective can be in line with U.S. opportunity. So it's quite significant from a patient numbers perspective. Of course, the second part of that is the pricing, which is a very key inflection point for us. That needs work, and that's kind of the work that we're doing. If you think about options for a company like us, it's really 3 different areas. One is the classical built-up model. The second on the other end is a full partnership with another pharma. We are not doing the first to be clear. That's not where we're pursuing a very big classical buildup. That's really not for us. Partnerships are always an option. But also what we are seeing in the marketplace still is an emergence of new models and new partners in Europe that can complement what we're doing because there are a lot of companies, U.S.-based biotechs that are having to put their thinking cap on and see how they can serve European patients. Many of them are choosing not to do anything about it, which we think is unfortunate for patients and for the mission. But at the same time, we want to make sure that we're doing a thoughtful work. So we're pursuing all these different opportunities, Gil. And before the end of the year, we will update the market in terms of where we land and what we think is the optimal way to bring RYTELO commercially to ex U.S. market.

And as a follow-up, will there be real-world data from imetelstat in low-risk MDS patients presented sometime this year?

Yes. Maybe I'll hand it over to Joe to address that question, it's a good question.

Yes. Gil, we have a slew of research -- investigator-sponsored research, including real-world data that will be presented at the upcoming meetings in the second half of this year as we have been saying. Some of it will include the real-world utilization in MDS and how it's playing out in the real world. And the early indication that we have mentioned in the past is that the data reflects the IMerge data from responses as well as [indiscernible].

And our next question comes from the line of Corinne Johnson of Goldman Sachs.

So I think you've talked about this one L2L share, and it's been pretty stable in the 30% range. Maybe you could talk to us about the tactics you're using to increase adoption in the earlier line population. And when you think we could start to see those educational efforts flowing through to changes in actual prescribing patterns in a more meaningful way?

Yes. I think if I heard you right, your question was about the first-line, second-line share of patients versus later. Okay, yes. So what we are communicating today, Corinne, is the share of our utilization in the first line, second line versus the later line is 33% this quarter with a 12-month look back. As you remember, last quarter, it was at 30% with a 12-month look back. So we continue to make progress in getting more and more of our patients in the first line, second line. And that's how we see our performance going forward is continuous progress, continuous growth quarter-over-quarter and that's the strategy we're pursuing, iterating our guidance for the top line between [ $220 million and $240 million ].

Our next question comes from the line of Emily Bodnar of H.C. Wainwright.

In terms of the 6% increase in demand in this quarter, what's your confidence in the sustainability of that for future quarters in 2026? And were there any seasonality impacts or other factors that you could specifically point to that helped increase demand in the first quarter?

Yes. Thank you, Emily. Yes, look, I mean, we're very pleased with where we are in Q1, where we have landed is in line with our expectations in terms of both top line growth, but also on the investment side. And our plan is to continue to grow quarter-over-quarter. That's the strategy we're pursuing regardless of seasonality, different things that will happen every year. We know that. But at the same time, we do expect a gradual and continuous growth quarter-over-quarter. This is one where we are communicating -- we have communicated that. We have a guidance for the year in terms of the top line. And we have also communicated that we think that growth would be more accelerated in the second half of the year, purely by the fact that we have done significant surgeries in Q4 and Q1 and a lot of these programs do need time to kick into action. And we want to continue to fuel this growth quarter-over-quarter. It's not -- we don't see it as like a total transformation inflection point between one day to the other. This is a story for us of continued growth quarter-over-quarter. We do believe that the potential is tremendous in this low-risk MDS area, and we look forward to serving more patients and continuing to grow the business.

[Operator Instructions] And our next question comes from the line of Stephen Willey of Stifel.

Just curious about the data you're seeing on the treatment duration and persistency front. I know that you've been in the market now, I guess, messaging the correlation between cytopenias and clinical benefit. Has that driven any measurable improvement in patient persistency over the last 4 to 5 months? And I just have a follow-up.

Yes, what we see in real world is really quite close to what we've seen in IMerge data in terms of patients -- average duration of patients staying on therapy on RYTELO. What we are pursuing is more patients in the first line, second line, and that would obviously increase the persistency of patients on treatment, right? So this quarter, we're up to 33% versus last quarter with a 12-month look back at [ 34% ]. So we want to see that number continuously and gradually grow. But within the line, at this point, what we see is really in line with what IMerge has shown us in terms of average duration of patients on therapy.

Okay. And then I just guess with the business approaching breakeven and presumably some level of confidence into achieving profitability, at least on a non-GAAP basis before the end of this year. Just curious how active some of the peripheral BD efforts might be right now. And just whether or not there's a specific stage of development that you're looking for in an asset and whether you think there's both the appetite and bandwidth to potentially execute on a transaction before the end of this year?

Yes. Thanks, Steve. Look, I mean, ultimately, our main focus is on growing RYTELO, especially in the U.S. for the time being, exploring ways to bring RYTELO to ex U.S. patients as well. We continue to do that. We have a healthy cash position with even more disciplined from a financial perspective to ensure that we're executing per plan but doing it in a financial disciplined manner. And that provides us, Steve, with a lot of different optionality in terms of wanting to do deals, not having to do deals, staying opportunistic, looking at where else can we build our company in terms of our long-term aspiration of building hematology company that's consistent and sustainable. So that's ultimately where we want to go. So we do have optionality, Steve. It's too early for us to comment on will we do a deal or not. We're always in the market looking for opportunities, but our very focused efforts are now on execution and making sure that RYTELO grows in line with our expectations and really by focusing on those 8,000 patients in U.S. in the second line, which we believe we can really help more and more of them as the quarters come.

I'm showing no further questions at this time. I'll now turn it back to Harout Semerjian for closing remarks.

Thank you very much, everyone, for joining our call today. We look forward to updating on our progress over the next quarters to come. Thank you very much. This concludes our call.

Thank you for your participation in today's conference. This does conclude the program. You may now disconnect.