Geron Reports Q1 2026 Results: Full Earnings Call Transcript

Geron Corporation

Geron Corporation

GERN

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On Wednesday, Geron (NASDAQ:GERN) discussed first-quarter financial results during its earnings call. The full transcript is provided below.

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The full earnings call is available at https://edge.media-server.com/mmc/p/5ucec3cw/

Summary

Geron reported first-quarter 2026 net revenue of $51.8 million, marking a 31% year-over-year increase and 8% quarter-over-quarter growth, aligning with their 2026 revenue guidance of $220-$240 million.

The company is focused on expanding Rytello's market presence in the US through increased awareness and education among healthcare professionals and strategic investments in digital marketing and research partnerships.

Geron is exploring commercial strategies for Rytello in Europe, emphasizing the need to balance patient access with maintaining pricing integrity, with plans to finalize their approach by the end of the year.

Total operating expenses decreased by 9% year-over-year to $50.4 million, illustrating financial discipline, with the company maintaining a strong cash position of $321 million.

The management team highlighted the importance of advancing clinical trials, particularly the Phase 3 IMPACT MF trial, and anticipates achieving key milestones in the second half of 2026.

Full Transcript

OPERATOR

Hello and welcome to Geron Corporation first quarter 2026 earnings call. At this time all participants are in listen-only mode. After this 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 automated messages. Your hand is raised to withdraw your question. Please press star 11 again. Please note that today's conference is being recorded. I will now turn the call over to Dawn Shotland, Senior Vice President, Investor Relations and Corporate Affairs. You may begin.

Dawn Shotland (Senior Vice President, Investor Relations and Corporate Affairs)

Good morning everyone. Welcome to Geron Corporation first quarter 2026 earnings conference call. Before we begin, please note that during the course of this presentation and question and answer sessions 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 Rytello commercialization strategy and related opportunities in the US and the EU, the therapeutic potential of Rytello, 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 risk 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 uncertainty disclosures, including his upcoming quarterly report on Form 10-Q. Geron undertakes no duty or obligation to update forward looking statements. Joining me on today's call are several members of Geron's management team. Harut Kemerjian, Chief Executive Officer, Ahmed El Nawabi, our Chief Commercial Officer, Dr. Joseph Eades, 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 Geron's progress and strategy.

Harut Kemerjian (Chief Executive Officer)

Thank you, Dawn and good morning everyone. In the first quarter, we made progress on our 2026 strategic priorities. We grew Rytello 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 at Geron, along with two new board members, Patricia Andrews and Constantine Chinopoulos. Collectively, they bring decades of experience leading and advising biopharmaceutical companies and will be instrumental as we execute on our strategic priorities and drive commercial growth For Rytello Rytello 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 $240 million we continue to see strong tailwind in the treatment landscape, complementing our refocused commercial strategy and driving Rytello's demand. We are focused on three key initiatives fueling our Rytello US Growth strategy. On the commercial side, we're continuing to increase awareness and education for Rytello amongst 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 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 US Hematology community to increase our knowledge and real world experience with Rytello. Growing Rytello's demand in the US market remains our priority and we know from patients and healthcare providers there is an unmet need for low risk MDS treatment options in Europe and an interest in Rytello 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 the responsibility to maintain a value that reflects our innovation and supports our next wave of growth. We know the demand in Europe for Rytello is real and we are exploring a innovative commercial strategy that could maximize Reytello's value in Europe while maintaining its pricing integrity in the US. 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 Geron. We report the 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 bonuses, severance from last year's restructuring and CMC investments to strengthen our supply chain for Rytello 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 Ahmed El Nawabi to provide more detail on Rytello's commercial performance and execution.

Ahmed El Nawabi (Chief Commercial Officer)

Thank you Haru Reutello's first corporate performance was implied. Our strategy is built to support sustainable growth and ensure Rytello 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, extending our footprints and zones to approximately 1450 accounts and first and second line patient starts on a rolling 12 month basis was 30%. Rytello has the potential to make the biggest impact for lower risk MDS patients in the second lab test 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 guideline. The movements of the statistic into the first line setting backed by Rytelo's broadband 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 engagements 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 counts for those primarily 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 surround sound or Rytello, ensuring consistent high quality messaging across multiple touch points. Third, we are executing cross functions through effective account management, leveraging data presented at ASH 2025 to proactively address the cytopenia and highlight the potential association with response while positioning Rytello 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 Rytella to eligible lower risk MDS patients and position us to grow demand in 2026. I now turn it over to Joe to discuss our medical and scientific thinking.

Joe

Thanks Naval. In the first quarter we continue to engage closely with the hematology community to increase Rytello's share of voice. Since the start of the year we've had a presence at several medical meetings including the Aplastic Anemia MDS International foundation 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 ASTHO and EHA where we will engage with hematologists to articulate the clear differentiation of Imetelstat and low risk MDS based on its clinical efficacy, quality of life benefits and mechanism of action, generate advocacy within the KOL community and support investigator interest and research opportunities online without medical strategies. These medical meetings enable us to further educate the hematology community on Rytello's deep body of scientific evidence. Our messaging continues to be focused on the ASH 2025 data suggesting treatment emergent cytopenia are consistent with on 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 examines the association between treatment emergent cytopenia and clinical responses to Rytella. We are also engaging with academic centers to support the high interest in the advanced MDS and real world evidence studies. Notably, we are seeing increased interest from centers in Europe wanting to contribute to pre 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 inclusion of LSAT in the National Comprehensive Data or NCCS Chemotherapy Order templates. Its inclusion positions Imetelstat as an active therapeutic versus supportive care for lower risk MDs. The order templates provide healthcare practitioners with clear guidance on administration, enabling imetelsat 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 Imetelsat as the preferred second line treatment option in lower risk MDS. Turning to our Phase 3 IMPACT MF trial and relapse refractory myeloplitis, the fully enrolled trial is projected at this time to reach the interminalis death event trigger in the second half of this year. Imetelstat works on the foundation of pipe, which is why we believe it has the potential to be a first in class therapy in myelofibrosis. In myelofibrosis, clinical trials conducted within the evidence of disease modifying activity correlating with clinical benefit and overall survival through a reduction in mutation burden, specifically JACK through CALR and NPL driver mutation, an improvement in bone marrow fibrosis and reduced telomerase activity which is an AS telomerase is significantly upregulated in cancers. For our Impact MF trial, overall survival is the primary endpoint and our confidence in this endpoint is supported by encouraging survival outcomes observed in the Phase two IMbark trial which informed the design of the impact MF 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 upstairs 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.

Michelle Robertson (Chief Financial Officer)

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 31, 2026 was $51.8 million compared to 39.6 million in Q1 2025. Gross 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 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 three months ended March 31, 2026 were $15 million, consistent with $15.1 million in expenses same period in 2025. For 2026, we expect continued investment in DMC 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 were $35.4 million compared to 40 million 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 Rytel Marshallization 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 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 $321 million cash equivalent. Restricted cash and marketable securities appear 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 Reitello, we are reiterating our 2026 financial guidance. We expect rightl 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 discipline. With that, I'll turn the call back to Haru for closing remarks.

Harut Kemerjian (Chief Executive Officer)

Thanks Michel. 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 Rytello to eligible patients and achieve our 2026 financial guidance. For the remainder of 2026 we are focused on growing Rytello in the US pursuing pathways to bring Rytello to patients outside the US, advancing our impact MF 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 and A session.

OPERATOR

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 one one again. Please stand by when we compile the Q and A roster. And our first question comes from the line of Tara Barncroft of TD Callum. Your line is not open.

Tara Barncroft

Hi, good morning. 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 Rytello and mds. Thank you so much.

Harut Kemerjian (Chief Executive Officer)

The 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 we think 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, you know, keep on going and if they tell us anything else, then all these material obviously that we would communicate this to the market accordingly. But Joe, do you want to add anything?

Joe

Yeah. Good morning, Tara. I think your question is how do physicians react to it? The second is disease area or indication where you do have a proof of concept and an overall survival at 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 in phase three with overall survival in an MF would definitely enhance and augment that awareness and that value of the Imetelstat in the hematology clinic.

Tara Barncroft

Great, thank you.

OPERATOR

Thank you. One moment for our next question. And Our next question, Crystal is Gilblum of Needham and Company. Your line is now open.

Gilblum

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,, you know, 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.

Harut Kemerjian (Chief Executive Officer)

Yeah, good morning, Gail. Yeah, in line with what we have said is we want to explore all options to bring Rytello to patients in Europe. As you know, the European opportunity from a patient numbers perspective can be in line with US 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 three different areas. One is the classical built up model. The second on the other end is a full partnership with another pharmacist 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, Gil, 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, US 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 are doing it 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 Rytello commercially to X US market.

Gilblum

Thank you for that. And as a follow up, will there be real world data from mf, Telstat and low risk MDS patients presented sometime this year? Thank you.

Joe

Yeah, maybe I'll hand it over to Joe to address that to take a question. Yeah, 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 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.

OPERATOR

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

Corinne Johnson

Good morning. So I think you 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 translating into to changes in actual prescribing patterns in a more meaningful way. Thanks.

Harut Kemerjian (Chief Executive Officer)

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 committing today, Corinne, is the share of our utilization. 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 20 and 240 million dollars.

Corinne Johnson

Okay, thank you.

OPERATOR

Thank you. One moment for our next question. Our next question comes to the line of Emily Bonner of hcm. Line is now open.

Harut Kemerjian (Chief Executive Officer)

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? Thanks. Yeah, thank you, Emily. Yeah, 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. That's the strategy we're pursuing regardless of seasonalities, 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 will be more accelerated in the second half of the year purely by the fact that we have done, you know, significant strategies in Q4 and Q1. And a lot of these programs do need time to take 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, 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 something

Emily Bonner

great. Thank you.

OPERATOR

Thank you. One moment for our next question. Again, as a reminder to ask a question you will need to press star 11 on your telephone. And our next question comes to the line of student Willie of Stifle. Your line is now open.

Steve

Yeah, good morning. Thanks for taking the questions. Just curious about the data you're seeing on the treatment duration and persistence fronts. I know that you've been in the market now, I guess messaging the correlation between cytopenias and clinical benefits, has that driven any measurable improvement in patient persistency over the last four to five months and then set follow up?

Harut Kemerjian (Chief Executive Officer)

Yeah, Good morning, Steve. Yeah, what we see in the real world is really quite close to what we've seen in IMERGE data, Steve, in terms of patients, average duration of patients staying on therapy on Rytello, what we are pursuing is more patients in the first line, second line and that would obviously increase the persistency of patients on treatment. So this quarter we're up to 33% versus last quarter with a 12 month look back was at 30%. 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 IMER has shown us in terms of average duration of patients on therapy.

Steve

And then I just guess with the business approaching break even 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.

Harut Kemerjian (Chief Executive Officer)

Yeah, thanks Steve. Look, I mean ultimately our main focus is on growing ripello, especially in the US for the time being, exploring, you know, ways to bring Rytello to ex-US patients as well. We continue to do that. We have a healthy cash position with healthy, even more discipline from a financial perspective to ensure that we're executing per plan but doing it in a financially disciplined manner. And that provides us 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 what our long term aspiration of building a hematology company that's consistent and sustainable. So that's ultimately where we want to go. So we do have optionality. It's too early for us to comment on will we do a deal or not. We're always, you know, in the market looking for opportunities. But our, you know, very focused efforts are now on execution, making sure that vital grows in line with our expectations. And really by focusing on those 8,000 patients in the US in the second line, which we believe we can really help more and more of them as the orders come.

Steve

All right, thanks.

OPERATOR

Thank you. I'm sure. No further questions at this time. I'll now turn it back to Harut Simrajan for closing remarks.

Harut Kemerjian (Chief Executive Officer)

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.

OPERATOR

This concludes our call. Thank you for your participation in today's conference. This concludes the program. You may now disconnect.

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