Geron Q3 2026 Earnings Call Transcript

Geron (NASDAQ:GERN) reported third-quarter financial results on Wednesday. The transcript from the company’s third-quarter earnings call has been provided below.

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Summary

Geron Corporation reported a 5% quarter-over-quarter net revenue growth to $60.1 million, with a 27% year-over-year increase, driven by Rytelo’s demand growth.

The company remains confident in achieving the mid to high end of its full-year 2026 net revenue guidance of $220 million to $240 million.

Geron initiated a gated commercial launch of Rytelo in targeted European markets, starting with Germany, allowing flexibility in partnerships and pricing strategies.

The IMPACT MF trial was discontinued due to unlikely success, but Geron plans to analyze the data for future insights.

Operating expenses decreased by 9% year to date, and cash on hand stood at $339 million, enabling continued investment in growth opportunities.

Management highlighted a focus on strategic business development in hematology/oncology to expand product offerings.

The company presented positive real-world evidence of Rytelo’s efficacy at major medical meetings, reinforcing its clinical potential.

Full Transcript

OPERATOR

Welcome to the Geron Corporation third 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 Chap, SVP, Investor Relations and Corporate Affairs. You may begin.

Dawn Chap (SVP, Investor Relations and Corporate Affairs)

Good morning, everyone. Welcome to the Geron Corporation third 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 related to our 2026 financial guidance, our current Rytelo commercialization strategy and related opportunities in the US and the EU, the therapeutic potential of Rytelo, other anticipated clinical and commercial events and related timelines, the sufficiency of our financial resources, and other statements that are not historical fact, which of course involve risks and uncertainties that could cause actual events, performance and results to differ materially from those contained in these forward-looking statements.

Therefore, I refer you to the risks and uncertainties described in today’s earnings release and other heading risk factors in Geron’s most recent periodic report filed with the SEC, which identify important factors that could cause actual results to differ materially from those contained in these forward-looking statements, and future updates to Geron’s risks and uncertainties disclosures, including in its upcoming quarterly report on Form 10-Q. Geron undertakes no duty or obligation to update its forward-looking statements.

Joining me on today’s call are several members of Geron’s management team: Harout Semerjian, Chief Executive Officer; Ahmed ElNawawi, our Chief Commercial Officer; Dr. Joseph Eid, Executive Vice President, Research and Development, and Chief Medical Officer; and Michelle Robertson, our Chief Financial Officer. With that, I’ll turn the call over to Harout to discuss Geron’s progress in the third quarter.

Harout Semerjian (President & CEO)

Thank you, Dawn, and good morning, everyone. We continue to execute our strategy to build a leading hematology company. We’re delivering consistent Rytelo demand growth, reinforcing our confidence in the low-risk MDS US commercial opportunity and Rytelo’s growth trajectory over the next several years. We also initiated a gated commercial launch in targeted European markets that gives us the optionality to scale up Rytelo’s availability through partnerships.

Last week we announced the discontinuation of the IMPACT MF trial evaluating imetelstat in JAK inhibitor–relapsed and refractory myelofibrosis, following a recommendation by the independent DMC. We believe this is the right course of action for patients and for Geron. In the third quarter we continued to see increased prescribing from community practices, leading to a quarter-over-quarter demand growth of 10% and net revenue growth of 5% to $60.1 million. This represents a 27% increase in net revenue year over year. This performance keeps us on track to achieve the mid to high end of our full-year 2026 net revenue guidance range of $220 million to $240 million and reinforces our confidence that Rytelo has a long growth runway in the US.

This year we started executing our ex-US go-to-market commercial strategy focused on addressing unmet patient needs and broadening access to Rytelo while prioritizing US price integrity. Recent developments, including the exclusion of orphan drugs like Rytelo from the CMS Globe model, give us the opportunity to serve more patients globally. We initiated a gated commercial launch to make Rytelo available in targeted European markets beginning with Germany, where Rytelo is expected to be commercially available by the end of this year.

In Europe, our approach enables us to retain strategic control of pricing without having to establish full infrastructure in each market or commit to a large upfront investment. This hybrid model also allows us to remain flexible and open to partnership opportunities to support our global reach. We recently increased our engagement and presentations at multiple international medical meetings and were encouraged by the interest from hematologists in key markets. We will continue to explore opportunities in other geographies where we believe we can help address the significant unmet need of low-risk MDS patients.

As we continue to strengthen our operations, another area of focus for us is financial discipline, where our investments are intentional and targeted. Our operating expenses were down 9% year to date compared to the prior year, reflecting our continued focus on operational efficiency. This discipline is enabling us to update our full-year 2026 total operating expense guidance range to $220 million to $230 million. With $339 million of cash on hand, we have a strong balance sheet to fund our current operations, which gives us flexibility to pursue business development opportunities.

With that, I’ll turn it over to Nawawi to provide more detail on Rytelo’s commercial performance and our execution.

Ahmed ElNawawi (Chief Commercial Officer)

Thank you, Harout. We are pleased to report our fourth consecutive quarter of demand growth for Rytelo, reinforcing the need for this drug and its potential long-term value as a preferred treatment in second-line low-risk MDS. In the third quarter we achieved a 10% demand growth for Rytelo compared to the second quarter of this year, an 8% increase in prescribing accounts predominantly from community practices, expanding our footprint to more than 1,700 accounts since launch, with first- and second-line patient starts on a rolling 12-month basis at 36%. We believe that Rytelo has the potential to deliver consistent quarter-over-quarter growth for years to come, driven in large part by continued adoption in the community setting, where there are still thousands of patients that can benefit from Rytelo.

Our focus is on accelerating that adoption through targeted personal and non-personal engagements that reinforce Rytelo’s differentiated clinical efficacy in second-line low-risk MDS patients while continuously educating heme-oncs on dosing and management of cytopenias. Rytelo’s unique mode of action as a first-in-class telomerase inhibitor, its broad label, and position in NCCN guidelines provide a strong foundation to drive durable long-term growth.

Turning to our efforts in Europe, we’re taking a gated operational approach where we drive regulatory engagement and local reimbursement processes to ensure Rytelo reaches the appropriate patients at a price that reflects its unique value. Our model allows us to broaden Rytelo’s access with a staged upfront investment while preserving flexibility for the future. We have already initiated our launch in Europe and plan to make Rytelo commercially available in Germany by the end of the year, with France to follow in 2027.

We are encouraged by the interest we’re seeing across markets, supported by investigator experience with imetelstat and the significant unmet need in low-risk MDS. I now turn it over to Joe to discuss our medical and scientific engagement efforts.

Joseph E. Eid (EVP, Head of Research and Development and Chief Medical Officer)

Thanks, Nawawi. Last week we announced our decision to discontinue the Phase 3 IMPACT MF trial evaluating imetelstat in JAK inhibitor–relapsed/refractory myelofibrosis. This decision was based on a recommendation from the Independent Data Monitoring Committee informing us that the trial was unlikely to meet its primary endpoint of overall survival. Importantly, there were no new safety signals observed in the trial that changed the known safety profile of imetelstat.

We are committed to unblinding the data, conducting a detailed analysis of this rich data set, and sharing findings at an upcoming medical meeting that may help inform future research. We are deeply grateful to the patients and families, as well as the investigators and clinical teams, whose dedication made this research possible. Turning to low-risk MDS, this quarter we presented at leading hematology meetings, both global and regional, further communicating the growing body of evidence supporting Rytelo’s differentiated profile, including evidence of disease-modifying activity. Just as importantly, these meetings created meaningful opportunities to engage directly with the medical community, exchange insights, and deepen scientific dialogue around the evolving treatment of low-risk MDS.

At SOHO, we continued to build strong momentum through impactful data presentations, sponsored education, and broad KOL engagement. Powered by a coordinated full-team approach, our low-risk MDS real-world evidence poster showed meaningful hemoglobin improvement with imetelstat despite short treatment duration and later-line use in US community oncology practice in the immediate post-launch period. This marked the second real-world evidence presentation this year, adding to the growing body of evidence that reinforces findings from our Phase 3 IMerge trial and the safety, efficacy, and tolerability profile of Rytelo.

Additional data presented at the 88th Annual Meeting of the Japanese Society of Hematology and at the 2026 annual meeting of the German, Austrian and Swiss Societies for Hematology and Medical Oncology further highlighted the durable clinical outcomes observed with imetelstat and expanded the growing body of evidence supporting its differentiated profile. Across the presentations, Phase 3 IMerge findings and real-world experience reinforce durability and clinical relevance of treatment outcomes, including findings suggesting that treatment-emergent cytopenias may reflect an on-target effect associated with meaningful clinical outcomes such as hemoglobin improvement and transfusion independence in low-risk MDS. Importantly, the presentations also demonstrated growing scientific interest and investigator experience with imetelstat outside the US as we continue to deepen engagement with the global hematology community.

Beyond congress presentations, we continue to strengthen the scientific foundation of Rytelo through two manuscripts published in peer-reviewed journals, further expanding the body of evidence supporting imetelstat’s role in low-risk MDS and its potential to address significant unmet need. Looking ahead, the 68th ASH annual meeting in December will provide another opportunity to build on this body of evidence with new data across low-risk MDS and other hematological diseases that will further inform our understanding of Rytelo’s clinical potential.

Our six accepted abstracts at ASH reinforce the clinical and biological evidence of Rytelo, and we look forward to sharing additional details later. Today, our progress has been recognized beyond the medical community. We are honored to have been nominated for the Prix Galien USA Award for Best Product for Orphan or Rare Diseases. This recognition represents decades of pioneering work in telomerase inhibition and, most importantly, a sustained commitment to addressing significant unmet needs for people living with low-risk MDS. It is a meaningful acknowledgment of the science behind Rytelo and the potential to translate that science into better outcomes for patients.

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 third quarter, please refer to the press release we issued this morning, which is available on our website. Our third quarter financial results highlight the progress we are making on our commercial strategy and operational excellence. We are in a strong financial position with a balance sheet that enables targeted and disciplined investments into further growth opportunities, including business development. In the third quarter, total net product revenue for the three months ended September 30, 2026 was $60.1 million compared to $47.2 million in Q3 of 2025. Gross-to-net deductions decreased to 19.3% for the three months ended September 30, 2026 compared to 21.6% 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 September 30, 2026 were $12.7 million compared to $21.1 million for the same period in 2025. The decrease in research and development expenses was a result of lower headcount costs from the workforce reduction in December 2025 and lower clinical chemistry, manufacturing and controls costs. For the remainder of 2026, we expect continued investment in CMC and our clinical post-marketing commitments, offset by lower employee costs due to wind-down activities.

We do not expect any significant decrease in spending on our MF program in 2026. Selling, general and administrative expenses for the three months ended September 30, 2026 were $35.7 million compared to $39 million for the same period in 2025. This decrease was primarily due to lower general and administrative personnel-related expenses as a result of the workforce reduction in December 2025. Total operating expenses, excluding COGS, for the three months ended September 30, 2026 were $48.3 million compared to $60.1 million for the same period in 2025.

As of September 30, 2026, we had approximately $339 million in cash, cash equivalents, restricted cash and marketable securities compared to $327 million as of June 30, 2026. We are committed to maintaining our financial discipline and are well positioned to fund growth from our current operations. We are reiterating our 2026 Rytelo net revenue guidance with the expectation we will come in at the mid to high end of the $220 million to $240 million range, reflecting consistent quarter-over-quarter net revenue growth throughout the year.

We are lowering our total operating expense guidance from $230 million to $240 million to the range of $220 million to $230 million. This reduction reflects our ability to drive continued operational excellence while also making strategic investments into Rytelo and future growth opportunities. With $339 million in cash, we are well positioned to execute on our financial and strategic priorities through the remainder of the year. With that, I’ll turn the call back to Harout for closing remarks.

Harout Semerjian (President & CEO)

Thanks, Michelle. Rytelo has grown for four consecutive quarters, placing us on track to achieve our 2026 net revenue guidance and maximize our long-term growth potential. Beyond Rytelo, our financial strength gives us the flexibility to explore business development opportunities to build a leading hematology company. Operator, we’re now ready to start the Q&A session.

OPERATOR

Thank you. As a reminder, to ask a question, please press star 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 Brancroft of TD Cowen. Your line is open.

Tara Brancroft (Analyst)

Hi, good morning. Thanks for taking the questions. So it’s great to see the reduced OPEX guidance this year. It all makes sense. But I’m wondering how we should think about OPEX expectations really going forward, especially with the MF Phase 3 not factored in. If there are any savings from that, maybe you could tell us also what you plan to put that towards in terms of future pipeline or any thoughts regarding that. That would be great. Thank you so much.

Harout Semerjian (President & CEO)

Yeah, thank you, Tara. Maybe that’s a question Michelle can address.

Michelle Robertson (Chief Financial Officer)

Thanks, Tara. So, yes, we reduced our OPEX for 2026. What I would say about the go-forward investment: we’ll continue to be very disciplined in our capital allocation. You will see some increases next year as our Europe strategy matures, as well as post-marketing commitments and clinical trials. So although the remainder of the OPEX will be steady, we will see some increases for those two material items.

Tara Brancroft (Analyst)

Okay, great. Thanks.

OPERATOR

Thank you. And our next question comes from Gil Plume of Needham. Your line is open.

Gil Plume (Analyst)

Good morning, and congrats on the progress here. So definitely seeing consistent growth quarter over quarter, kind of in the low single digits. What do you think could cause a rate change or change in the rate of uptake that would be more of an acceleration? And is this something we should expect, or should we continue to see this kind of consistent growth over time? And I have a follow-up. Thank you.

Harout Semerjian (President & CEO)

Thank you, Gil. As we have communicated multiple quarters ago, the way we look at Rytelo’s growth, if we do things well, is it will deliver consistent growth quarter over quarter. And we’re very pleased today to announce the fourth quarter of that strategy in action where we continue every quarter to increase demand, to increase sales, to increase penetration in the first-line, second-line market patient segments, and to reduce OPEX. And we believe that’s a winning strategy in the long term.

I know sometimes people ask us what is the exact inflection point, and we continue to maintain this is a growth quarter over quarter if we do this well. And we do believe that there are thousands more patients who can benefit from Rytelo for many years to come. That’s why we do see the long-term perspective of Rytelo growth quite good. But the curve of the growth is really what we are pleased with, and we think that this is something that we can continue to grow.

I hope that answers your question. And I think you had a follow-up.

Gil Plume (Analyst)

Yeah, that was helpful. And just given the financial discipline here and pretty meaningful cash position, you guys mentioned BD a couple of times. Is there a specific character product that you’re looking for? Is this likely a heme-onc asset? I mean, any guidelines that you can give as to what you’re thinking of? Thank you.

Harout Semerjian (President & CEO)

Sure. Yeah. So, if you step back and look at where we are as a company, we have a very healthy base business in Rytelo in the U.S. that’s growing every quarter, and we reiterated our mid- to high-level of our guidance of $230 to $240 million. So that’s from a U.S. perspective. We’re also today very excited to share that the work that has happened, especially in Europe over the last several months, especially on the pricing side, puts us in a very good position to actually make Rytelo available in a commercial setting, starting with Germany before end of the year and then rolling into other countries such as France next year, while maintaining optionality of partnership, which is really a win-win strategy that doesn’t put us in a situation where we have to shell out a lot up front.

We do it in a very, very specific way. Now, coming to BD, this also allows us, especially now with the MF overhang behind us—obviously we’re going to be looking into that very rich database and truly understand what are some of the trends in myelofibrosis. But given that that never was really part of our base strategy, at least not in the last couple of years—it was always treated as an upside—we’re in a good situation to really pursue BD opportunities. We have a winning team in the U.S. from a commercialization perspective.

What would make the most sense is really to bring in another asset to put it in the bag of that team that’s shown its ability to grow Rytelo and to get into other hematology/oncology assets. As you know, 80% of this business is actually in the community, so it can really be any asset in hematology or oncology that is predominantly a community disease as a first bullseye. And then we will keep the right to be opportunistic beyond that, given that our approach of being very selective, targeted where we invest, and really drive value through that has now been taking life over the last four quarters, I would say.

And we do believe we can do that with other assets. We’re not competing with a Pfizer or Novartis with needing assets with $2 billion, $3 billion peak sales. Assets that have a few hundred million potential peak sales are plenty for us. And then we can pursue a string-of-pearls approach with that over the next several years. So that’s what we’re excited about—not just for the base business, but also where we can go with BD. Does that help answer the question, Gil?

Gil Plume (Analyst)

Yeah, very helpful and thank you for taking our question.

Harout Semerjian (President & CEO)

Of course.

OPERATOR

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

Stephen Willey (Analyst)

Yeah, good morning. Thanks for taking the questions. Maybe just a quick housekeeping question for Michelle: any notable changes to inventory during the quarter? And then I just have a follow-up.

Michelle Robertson (Chief Financial Officer)

No, Steve. We remained within our two to four weeks guidance that we shared in the past.

Stephen Willey (Analyst)

And then just curious about how you’re thinking about the opportunity here in Europe. I know that you’re initially entering kind of a very limited number of markets, but can you maybe speak to any differences in how the disease might be managed there just relative to the U.S.? I guess when I look at Reblozyl, they’re generating less than 20% of their sales ex-U.S., which I’m sure is partially pricing-based, but would perhaps suggest some differences in terms of how the disease is managed.

Harout Semerjian (President & CEO)

Sure. Maybe I’ll start off and Ahmed can supplement as well. Look, from a patient perspective, it’s really the same size of number of patients that we have in the U.S. In the U.S., we’ve said about 8,000 patients would be eligible for that second-line patient population, and then, as you know, European average age is even older. So it’s at least that number of patients from a macro perspective overall. The reason we’re choosing Germany to go with— that is the country where you have a meaningful path for innovation at a healthy pricing point in line with the innovation that we can bring.

Ahmed, do you want to add on top of that additional reasons?

Ahmed ElNawawi (Chief Commercial Officer)

Sure. And a couple of points, Steve, is that you refer to Reblozyl (BMS). They’ve gone through several price iterations because of their broader label and multiple indications. We are a single indication drug with an orphan designation, which does give us high scoring, especially in Germany from a reimbursement perspective. Plus, the market is not as diversified in terms of treatment options in Europe compared to the U.S., where in the U.S. we see a much higher use of HMAs in second and third line, which is not what the European markets are doing.

So we see a bit of differences, and time will tell.

Harout Semerjian (President & CEO)

Yeah. And—

Ahmed ElNawawi (Chief Commercial Officer)

Just to be also address the revolution point you made, Steve. I mean, as you probably know, in most European markets it is restricted to RS-positive, and typically larger pharma has to think about their portfolio overall, especially protecting larger products like their PD-1s. We don’t have that hindrance in that. So we have a label that we can pursue, especially in an RS-negative patient population, orphan designation. HMAs are not as entrenched in Europe, older population.

And, as you know, the clinical trial we had, IMerge, was predominantly a European trial. So there’s significant advocacy as well from the medical community wanting to see RYTELO available for that patient.

Stephen Willey (Analyst)

All right, very helpful. Congratulations on achieving profitability. Thanks.

OPERATOR

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

Harout Semerjian (President & CEO)

Thank you. To everyone joining our call today, we look forward to updating you on the progress in the next several quarters.

OPERATOR

Thank you. This concludes today’s conference call. Thank you for participating. And you may now disconnect.

Disclaimer: This transcript is provided for informational purposes only. While we strive for accuracy, there may be errors or omissions in this automated transcription. For official company statements and financial information, please refer to the company’s SEC filings and official press releases. Corporate participants’ and analysts’ statements reflect their views as of the date of this call and are subject to change without notice.