Geron Corp (GERN) Q1 2026 Earnings Call Transcript

Hello, and welcome to General Incorporation First Quarter 2026 Earnings Call. At this time, all participants are on listen-only mode. After this previous 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 your visor your hand is raised. To withdraw your question, please press star 11 again. Please revise that today's conference will be recorded. I'll turn the call over to Dawn Shotland, Senior Vice President, Investment Relations and Corporate Affairs. You may begin.

Good morning, everyone. Welcome to the Jaron Corporation first 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 relating 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 facts, which of course involve risks and uncertainties that could cause actual events, performance, and results that differ materially from those contained in these forward-looking statements. Therefore, referring to the risk and affirm these described in today's earnings release and under the heading risk factors in Geron's most recent periodic report filed with the SEC, which identified important risk factors that could cause actual results to differ materially from those contained in these voter-looking statements and feature updates to Geron's risks and uncertainty disclosures, including its upcoming quarterly report on Form 10-Q. Geron undertakes no duty or obligation to update its voter-looking statements. Joining me in today's call are several members of Jerram's management team, Harut Khmerjian, Chief Executive Officer, Ahmed El-Nawabi, our Chief Commercial Officer, Dr. Joseph Yves, 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 Harut to review Jerram'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 Ritello to focus commercial execution and advanced our European commercial and pricing strategy while maintaining our financial system. We also further strengthened our leadership team by welcoming Timothy Williams, our new Chief Legal Officer and Corporate Secretary, for Jerome, along with two new board members, Patricia Andrews and Konstantin Chinopoulos. Collectively, they bring decades of experience leading and advising by our practical companies and will be instrumental as we execute on our strategic priorities and drive commercial growth for right now. Right now, 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 Ritello demand. We are focused on three key initiatives fueling our Ritello US road strategy. On the commercial side, We're continuing to increase awareness and education for right health amongst U.S. healthcare 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 dermatology forums through accelerated investment in our surround sound approach. From a medical affairs perspective, we are expanding our research partnership and investigator-sponsored trial program with the U.S. hematology community to increase our knowledge and real-world experience with Rytelo. Growing Rytelo demand in U.S. markets remains our priority, and we know from patients at STD there is an unmet need for low-risk MDS treatment options in Europe and an interest in right help to help address that need this quarter we engaged in conversations with european medical experts made progress with health psychology assessments 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 the responsibility goals to maintain a value that reflects our innovation and supports our next wave of goals. We know the demand in Europe for Ritello is real, and we are exploring an latest commercial strategy that could maximize Ritello's value in growth, 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 opportunities. Financial discipline remains another top priority for Jerox. 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 CNC investments to strengthen our supply chain for Ritello 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 dollars. With that, I'll turn it over to Nauagic to provide more detail on Ritello's commercial performance and execution.

Thank you, Horowitz. Ritello's first quarter performance was in crisis. Our strategy is built to support sustainable growth and ensure Ritello reaches more eligible patients at the right point in their treatment period, 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 long to approximately 14-15 accounts. And first and second line patient starts on the rolling 12 month basis was 33%. Raitello has the potential to make the biggest increase for lower risk MDS patients in the second line setting, which we currently estimate to be approximately 8,000 patients in the year. This patient segment is our primary commercial focus and our strategy is supported by the current NCCN guidelines. the movement for blue scatterstacks into the first-line setting, backed by Ritello's broad data, a 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 three 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 engagement. Additionally, we continue to engage with lower volume accounts for those primary treating 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 a 3D setup, ensuring consistent, high-quality messaging across multiple such boards. We are executing cross-function through effective accounts management, leveraging data presented at ASH-25 to proactively address the cytopenia and highlight the potential association with response while positioning Ritello as these standards of care in appropriate second-line patients regardless of their RS. We believe our commercial strategy and investments are well aligned to bring Ritello to eligible lower-risk MDS patients in the U.S. and position us to grow in 2020. I now turn it over to Joe to discuss our MediCAD and scientific engagement. Thanks, Nawal.

In the first quarter, we continue to engage closely with the hematology community to increase my fellow share reports. Since the start of the year, we've had a presence at several medical meetings, including the Aplastic Anemia MGS International Foundation, LASCO, and the 2015 Expand and 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 a clear differentiation of themselves as in low-risk MDS based on clinical efficacy, quality of life benefits, and mechanism of action, generate advocacy within the KOL community and support investigator interest and research opportunities online 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 emergency cytopenia are consistent with off-target activities. We are seeing increasing interest from community hematologists in 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 ITEROS. We are also engaging with academic centers to support the high interest in the southpads to advance ISDs and real world evidence study. Notably, we are seeing increased interest from centers in Europe wanting to contribute to pre-clinical and real-world evidence data generation. We expect the initial real-world evidence data to be available in the second half of In addition, we are pleased to have achieved inclusion of InSELSTAT in the National Comprehensive Test, or NCCM, chemotherapy order template. Its inclusion positions IMITELSTAT as an active therapeutic versus supportive care for lower risk MDS. The order templates provide healthcare practitioners with clear guidance on administration, enabling IMITELSTAT 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 IMITELSTAT as with preferred second-line treatment options and lower-risk MTS. Turning to our Phase III IMPACT-MF trial in relapsed refractive myelofibrosis, the fully enrolled trial is projected at this time to reach the interim and out-of-death event trigger in the second half of this year. The MATEL-STAD 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 trials conducted And so evidence of disease-modifying activity formulating with clinical benefits and overall survival through a reduction in mutation burden, specifically JAK through CALR and NPL driver mutation. An improvement in bone marrow fibrosis and reduced telomerase activity, which is important as telomerase is significantly upregulated in cancers. For our impact MS file, overall survival is the primary endpoint, and our confidence in this endpoint is supported by encouraging survival outcomes observed in the phase two embark trial which informed the design of the impact on that trial. While our base case from a planning perspective remains a progression to the final analysis of the second half of 2028, reaching the interim analysis represents an important milestone as we continue to advance our potential beyond lower risk MDS. An earlier positive outcome would represent an upside scenario 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 three months ended March 31st, 2026, with 51.8 million dollars, compared to 39.6 million in Q1, 2025. Road to net deductions increased to 21% for the three months ended March 31st, 2026, compared to 13% for the same period last year. As volume increased, there was wider 3.3 utilization and expanded GPO contracting, which we proceed continuing as business insurers. For the remainder of 2026, we expect gross to net to be in the low to mid-20s. Research and development expenses for the three months ended March 31, 2026 were $15 million, assistance was $15.1 million in expenses in the same period in 2025. For 2026, we expect continued investment with CMC in 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 administrative expenses for the three months ended March 31, 2026, with $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 right-hand commercialization strategy and lower GNA personnel-related expenses driven by a decrease in headcount as a result of the workforce reduction in 2025. Total operating expenses, including cost of goods sold, for the three months as in March 31st, 2026, were $50.4 million dollars compared to 65.1 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 31st, 2026, we had approximately $321 million cash, cash equivalent, restricted cash, and lockable securities compared to $401 million as of December 31st, 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 strategic restructuring we announced in September 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 Ritello. We are reiterating our 2026 financial value. We expect Ritello net revenue, $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 Ritello while maintaining financial with it with that i'll turn the call back to the roof for closing remarks thanks michelle we continue to build a patient-focused performance-driven culture at gerald 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 Ritello to eligible patients, and achieve our 2026 financial guidance. For the remainder of 2026, we are focused on growing Ritello in the U.S., pursuing pathways to bring Ritello to patients outside the U.S., advancing our impact MS trials, remaining financially disciplined, and evaluating opportunistic innovation as we build GERON into a leading dermatology company. Thank you again for your time and interest in GERON, operator. We're now ready to start the Q&A session.

Thank you. At this time, we'll conduct a question and answer session. As a reminder to ask a question, you need to 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 when we compile the Q&A roster. And our first question comes from the line of Tara Berencroft of TD Calendry. The line is not open.

So, I have a question on MF. So, you know, 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. 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 Ritello and MDF. Thank you so much.

This 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 things that the DMC would meet, and obviously we're blinded as 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 you know keep on going and if they have anything else then all these material obviously that would would communicate to the market accordingly but Joe do you want to add anything yeah good morning Tara I think your question is how do physicians react to a second disease or indication where you do have a proof of concept and an overall survival as that.

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 with phase three with overall survival of MS would definitely enhance and augment that awareness and that value of the stuff that in the immunology.

Great. Thank you.

Thank you. One moment for our next question. And our next question comes on line of Gilblum of Nino and Company. Your line is now open.

Good morning and congrats on the progress. Just a quick one from us. As it relates to European markets, you guys said you may have conducted some market research. Just 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? Thank you.

Yeah, good morning, Gail. Yeah, in line with what we have said, we want to explore all options to bring Ritello to patients in Europe. As you know, the European opportunity from patient numbers perspective can be in line with us opportunities so it's quite significant from a patient numbers perspective of course the second part of that is the pricing which which is a very key inflection point for us uh that needs work and that's kind of the work that we're doing uh if you think about options for a company like us it's really three 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 build-up. That's really not for us. Partnerships are always an option. But also what we are seeing in the marketplace deal 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 you know 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 its thoughtful work so we're pursuing all these different opportunities uh gail um and uh and 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 Dritello commercially to the XGS market.

Thank you for that.

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

Thank you.

Yeah, maybe I'll hand it over to Joe to address that if they get the question.

Yeah, we have a smoke of research, investigator-sponsored research, including real-world data that will be presented at the upcoming meetings in the second half of the year, as we have been saying. Some of it will include the real-world utilization and how it's playing out in the real world. And the early, you know, indication that we have mentioned in the past is that the data reflects the, you know, data from the responses as well as .

Thank you. One moment for our next question. And our next question comes from the line of Corrine Johnson of Goldman Sachs. Your line is now open.

Good morning. So, I think you've talked about this 1L2L 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 Yes, good morning, Corinne.

I think if I heard you right, your question was about the first-line, second-line share of patients versus later. Okay, good. yeah so what we are committed today Corinne is the uh share of our utilization the first last second line versus the later line is 33 percent this quarter with a 12-month look back as you uh remember last quarter it wasn't 30 percent with a 12-month uh look back so we continue to make progress in getting more and more of our patients in the first line second the 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 20 and 20 to $40 million.

Okay.

Thank you for a moment for our next question. Our next question comes to the line of Emily Bodner of HCM. Your line is now open.

Hi, good morning. Thanks for taking the questions. In terms of the 6% increase of 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?

Yeah, thank you, Emily. Yeah, look i mean we're very pleased with where we are in q1 uh where we have landed is in line with our expectations in terms of both offline growth but also on the investment side and our plan is to continue to grow quarters for you know over quarter that's the strategy we're pursuing uh regardless of nationalities uh different things that will happen every year we know that but at the same time you know we do expect a gradual um and you know 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 clearly by the fact that we have done you know significant surgeries uh in q4 and q1 and a lot of these programs uh do need time to stick into action and we want to continue to fuel this growth quarter over quarter it's not that we don't see it as like a a total transformation inflection points between one day to the other this is a story for us of continuous 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 something that needs to go to business. Great. Thank you.

Thank you. One moment for our next question. Again, as a reminder to test a question, you will need to press star one one on your telephone. And our next question comes from the line of Stephen Willey of Stifo. Your line is now open.

Yeah, good morning. Thanks for taking the questions. Just curious about the data you're seeing on the treatment duration and persistency fronts? 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 four to five months? And then to help follow-up. Good morning, Steve.

Yeah, what we see in the real world is really quite close to what we've seen in iMerge that's the in terms of patients average duration of patients staying on therapy on Ritello uh what we are you know pursuing is more patients in the first line second line um and that would you know obviously increase the persistency uh all patients on treatment right so you know this quarter we're we're off to 33 percent versus last quarter with a full month look back well then 34 percent so So, you know, 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, you know, average duration of patients on therapy.

And then I just guess, you know, 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 you know 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 yeah thanks uh steve um so i mean ultimately

Obviously, our main focus is on growing Ritello, especially in the US for the time being, exploring, you know, ways to bring Ritello to XGS patients as well. We continue to do that. We have a healthy cash position with even more disciplines from a financial perspective to ensure that we're executing per plan by doing it in a financial discipline manner. And that provides us with a lot of different optionality in terms of, you know, wanting to do deals, not having to do deals, you know, staying opportunistic, looking at where else can we build our company in terms of what our long-term aspiration of building a rheumatology, you know, a company that's consistent and sustainable. So that's ultimately where we want to go. So we do have optionality, Steve. It's totally 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, making sure that price have a goal in line with our expectations, and really by focusing on those 8,000 patients in the S in the second line, which we believe we can really help more and more of them as the quarters.

All right. Thanks.

Thank you. I'm showing no further questions at this time. I'll now turn it back to Harut Simerjan for closing remarks.

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

Thank you for your participation in today's conference. To just conclude the program, you may now disconnect.