Q3 2025 Geron Corp Earnings Call

Speaker #1: Hello and welcome to the Geron Corporation . Third quarter 2020 Earnings Call . All lines have been placed on mute to prevent any background noise .

Speaker #1: After the speakers remarks , there will be a question and answer session . And if you would like to ask a question during this time , please press star one on your telephone keypad .

Speaker #1: I would now like to turn the call over to Don Sheldon , Vice Senior Vice President , Investor Relations and Corporate Affairs . You may begin .

Speaker #2: Good morning everyone . Welcome to the Geron Corporation . Third quarter 2020 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 the launch commercial opportunity and therapeutic potential of anticipated clinical and commercial events and related timelines .

Speaker #2: The sufficiency of financial resources and other statements that are not historical facts , actual events or results could differ materially . Therefore , I refer you to the discussion under the heading Risk Factors in Geron's most recent periodic report filed with the SEC , which identifies important factors that could cause actual results to differ materially from those contained in the forward looking statements and our future updates to those risk factors .

Speaker #2: Geron undertakes no duty or obligation to update our forward looking statements . Joining me on today's call are several members of Geron's management team chief Executive officer Michelle Robertson Chief Financial Officer and Doctor Joseph Eade , executive vice president of research and development and chief medical officer Ahmed El Nawawi , our chief commercial officer , will be introducing himself at the beginning of Q&A before handing the call over to her .

Speaker #2: I'd like to say I'm truly energized to join Geron . This is a company that can change the lives of patients with blood cancers .

Speaker #2: The work ahead of us is real , but in my three weeks here , my confidence in our ability to deliver has grown every day .

Speaker #2: With that , I'll turn the call over to Harold .

Speaker #3: Thank you , Don , and good morning , everyone . I'm very excited to be hosting my first earnings call as CEO of GERON CORP .

Speaker #3: On this call , we will provide a commercial overview and update on medical affairs and our pipeline , and end with an overview of our financials .

Speaker #3: Three months ago , I joined Geron because I saw a company with real promise a differentiated product that is effective and it addresses a high unmet need in low risk MDS over these past months , I've been deeply impressed by the strength and dedication of our organization .

Speaker #3: The culture here is patient , focused and resilient , giving me conviction that with improved alignment , we can build an execution oriented organization that brings the promise of rytelo to more lower risk MDS patients .

Speaker #3: Let me share four reasons that support our belief . First is a compelling drug . It has demonstrated meaningful efficacy in lower risk MDS , and it is differentiated in its mechanism of action and clinical profile .

Speaker #3: Second , lower risk MDS is an area of high unmet need with few , if any , potential treatments being studied in the clinic .

Speaker #3: That can provide the differentiation that can address inhibitor . There is a clear opportunity for retailers to be an important therapeutic option in low risk MDS .

Speaker #3: Third , there is an opportunity to accelerate growth with the right strategy and improved execution . And fourth , the company is well capitalized .

Speaker #3: We have a strong cash position , which we believe is sufficient to support the robust commercial and medical affairs engagement needed to increase utilization .

Speaker #3: Now , let me provide you with an overview of our Q3 commercial performance . Net product revenue was $47.2 million for the third quarter .

Speaker #3: During the quarter , demand for retail was down 3% compared to last quarter . New patient starts in first and second line increased to 36% , compared to 30% in Q2 .

Speaker #3: However , new patient starts did not offset the discontinuations we saw from patients using retail and later lines . It is clear we have work to do on establishing retail as a second line therapy in eligible patients with low risk MDS and educating HCPs on treatment management , prescribing accounts increased by 15% in the quarter , with approximately 150 new ordering accounts added in Q3 .

Speaker #3: Expanding our footprint to 1150 accounts . Lastly , we completed the first shipment of retailer to Germany under a named patient Early Access program .

Speaker #3: We are preparing for the planned commercialization of retailer in select EU markets in 2026 . Q3 was an important quarter for us as we took stock of what we need to do to insure retailer reaches more patients .

Speaker #3: We're assessing both internally , across people , processes , messaging and overall effectiveness and externally with our customers to amplify partnerships and ensure the appropriate usage of retailer .

Speaker #3: We recently announced the addition of Ahmed Al-Nawawi as our new Chief Commercial Officer. Nawawi is an experienced commercial leader with an established track record of launching multiple global oncology products and leading commercial teams in both biotech and pharma.

Speaker #3: He brings a wealth of expertise to Geron to execute a strong commercial strategy to support retailer growth . With the recently announced additions to the executive leadership team , along with existing team members .

Speaker #3: We can realign to accelerate momentum and grow retail . I'm confident we can realize the full value of retail and build a bright future for Gerald .

Speaker #3: We believe Gerald and retail can be transformational in lower risk MDS space with improved execution . We have already identified four initial actions to step up our execution and support future revenue growth .

Speaker #3: First , we need to substantially increase awareness for retailer among us Hcp's through a comprehensive well coordinated account plan . Our market research is clearly telling us that education is key to increasing usage in the appropriate patients .

Speaker #3: This is especially critical when an HCP prescribes retailer to the first few patients . Our field based commercial and medical colleagues have sharpened their approach to customer engagement , aimed at educating hcp's on how to use retail , identifying the appropriate patients to start therapy , expanding reach into community sites , improving conversions and retention , and effectively managing patients on therapy .

Speaker #3: We believe over time , this push to increase awareness for retail will grow our US prescriber base and drive sales in the US .

Speaker #3: Second, we need to significantly and consistently increase our in-person and digital presence in hematology forums. We are just starting to do this through expanded relationships with us.

Speaker #3: Kols and increased engagement with key patient advocacy groups . A good example of this would be Gerald's efforts at this year's Society of Hematology Oncology conference in September in Houston .

Speaker #3: At the conclusion of this conference , we noticed a surge in engagement from physicians who participated in our multiple advisory boards and other engagement activities with a positive change in Gerald's external perception .

Speaker #3: We received anecdotal feedback that more physicians are beginning to shift their thinking on retail , not just as a third or fourth line option , but as a therapy worth considering earlier that shift won't happen overnight , but as we continue these efforts throughout 2026 , we expect to see an impact on retail utilization .

Speaker #3: Lastly , we're excited to expand our ISD program with us clinical sites and how to address additional key medical questions about potential uses of Imetelstat and the benefits of telomerase inhibition .

Speaker #3: The Emerge trial , predominantly enrolled sites in Europe . We have work to do to collaborate with us and give them opportunities for additional research with Imetelstat .

there will also be 3 additional posters including data from the Embark and improve MF, trials in MF and the investigator sponsor trial impress in high-risk MDS and AML

We plan to continue our medical engagement at Ash.

We are planning an advocacy Forum that is designed to bring together patient, advocacy organizations and professional societies to raise awareness and provide education on Lower risk MDS, and the use of retell as a treatment option. This is the first event of this nature hosted by giron,

in addition, we are planning to engage with an increasing number of hematologists at Ash both in 1-on-1 and group settings. These engagements, help us convey new data to Physicians as well as collect insights that can help refine our strategy.

Community site, penetration.

Initiation of isds.

Awareness and education ramp up.

And kol and advocacy alignment.

We strongly recognized that in order for Attalla to be successful. We need to be successful in the community setting where Approximately 80% of lower risk. NDS patients are treated

last quarter. We described how we are focusing on increasing hcp awareness of right to particularly in the community setting, as well as academic centers that were not part of the phase 3 pivotal trial.

Our team has been actively engaged with these sites directly at an important medical meetings.

the expansion of our medical Affairs field team has allowed us to refine our targeting model better prioritize mid this style of Physicians and improve awareness among Community sites

We continue to intensify our messaging via webinars and peer-to-peer, educational efforts.

In our most recent awareness trial utilization tracking, we observed positive shifts. In physician, understanding of vtols efficacy in terms of robust and durable. Hemoglobin response. And appreciation of cytopenia, be an on-target based on right allows unique mechanism of action.

In parallel, we continue to support several investigator, sponsor, trials, exploring a metal that in diverse methodological settings, including combination regimen and earlier line use as well as real world evidence.

We expect that these independent studies will help build external validation and broaden the clinical and real-world evidence base for the Fork imal set.

We observe High interest investigating initial setting, preclinical clinical, and real world evidence settings.

We received a good number of proposals and we decided to fund a number of these proposals that we expected to commence generating data in 2026.

We are also actively engaging with cosas and advocacy groups to broaden the reach of, right? Tell us data, narratives.

Our goal is to help key opinion leaders become ambassadors, reinforcing that the trial can be considered alongside existing therapies in earlier lines, rather than a drug of last resort.

These efforts are starting to yield early Results. Post engagement, surveys. Suggest that Physicians who initially Express reservations about side of Pia. Now report, a better understanding of the mechanism of action. Those adjustment strategies and monitoring protocols, our data confirmed that Physicians who have used right Tello in practice view, its profile, more favorably than those who have not

As many of you know, the annual Society of Mythological Oncology meeting was a major touchpoint this quarter.

Our team presented, real world case, studies translational biomarker data and longer term follow-up from earlier, 3D patients.

The reception was constructed among key opinion. Leaders. We are seeing a growing perspective that Rael deserves the position as the number 2 option for eligible patients with lower risk and DS.

At the standards. CSA therapy is especially in certain high risks of population.

This is supported by the recently updated. Nccn guidelines that now recommend row as a treatment for use in low-risk, MDS patients with serum EO over 500 ahead of hmas

The central theme during the Soho meeting was however, I tell those use fits with this matter set.

We made the case that Telo and the status can be complementary rather than mutually exclusive.

On the clinical front. I am pleased to report that our impact and as trial is now fully enrolled with 320 patients from 26 countries.

This is a phase 3. Trial in relapse refractory Milo fibrosis and is the first MF clinical trial with overall survival as the primary endpoint.

We expect to have interim analysis in the second half of 2026, and the final analysis in the second half of 2028 subject, of course, to achieving the specified number of death events.

With a high bar set for the interim analysis. We are planning for the trial to conclude at its final analysis. This is typical for a trial with the primary endpoint of OS.

Affairs and R&D teams remain fully aligned with our commercial team. Our combined efforts are focused on evidence generation physician engagement and data dissemination to support broader adoption of Rital in lower risk NDS.

I'll now turn the call over to Michelle to go over our Q3 financials.

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.

As a September 30th 2025, we had approximately 420 million in cash and marketable securities compared to 503 million as of December. 31st 2024 total, net revenue for the 3-month ended. September 30th 2025 were 47 million compared to 28 million in Q3 of 2024.

Close to net increased.

Q2 to Q3 due to increases in the Medicaid. Mix rate fees from new GPO contracts and returns from several customers where their supply of retell had reached, its expiration date.

As of September 30th, 2025 ending inventory at Distributors was on the high end of our range of 2 to 4 weeks.

Research and development expenses for the 3-month end in September 30th. 2025 were 21 million compared to 20 million for the same period in 2024.

The change was primarily due to increased CMC in Personnel related expenses.

Selling, general, and administrative expenses for the three months ended September 30, 2025, were $39 million, compared to $36 million in Q3 last year.

The change was due to an increase in sales and marketing had count and additional investments in marketing programs.

For fiscal year 2025, we expect our total operating expenses to be between 250 and 260 million below. Our previously announced guidance of 270 million to 285 million

We continue to focus on efficiencies and prudently, manage our spends while continuing to prioritize investments in our right to commercialization strategy, commercial Supply, redundancies and postmarketing commitments, as well as preparations to launch ritello and selected EU countries in 2026.

Overall with our current cash and marketable securities in anticipated net revenues from expected Us sales of below. We believe that giron remains in a strong financial position to fund, projected operating expenses for the foreseeable future.

I'll now turn the call back to harute for closing remarks.

Thank you, Michelle. In closing, I want to reinforce three key takeaways from this call. Number one, shifting physician behavior and building a brand in hematology takes time. The urgency across our organization is understood, and we're fully committed to the patients who are depending on us.

Number 2, improving the alignment and generating momentum is our Focus.

And lastly write teller is a drug that works with the right execution, we believe it can be positioned for long-term success.

We appreciate your support.

Before we begin our Q&A, I'd like to hand it over to Nawawi, our new CCO, to say a few words introducing himself. Thank you. Let me start by saying thank you for the opportunity to be part of the Geron team.

I am halfway through my third week and what I have seen through my 1-on-1 and team meetings with the entire commercial organization.

That we are deeply committed to patients.

We have a drug right that has the potential to address an unmet need in low-risk MDS patients.

With improved alignment and our focus on driving operational excellence. I am confident, we can grow Revenue by delivering rotello to eligible patients.

Thank you, nawawi. Operator, we're ready for Q&A.

Thank you. If you would like to ask a question, please press star 1 on your telephone keypad, if you would like to withdraw your question, simply press star 1 again,

Please ensure that your phone is not on mute when called upon thank you.

Your first question comes from Tara bankroft with TD Cowen, your line is open.

Um, that this discontinuation and later lines is a big factor, but I'm curious to hear if there were other headwinds that you can speak of, um, this quarter that you observed, like, you know, reluctance to reorder or seasonality. But basically any looking for, for any outlook on those for Q4, um, that may perhaps be reversing. Thanks so much.

Hi Sarah. Um, thanks. Um, yes, so I I believe that the mid to high teams um, is still applicable for um the forecast. Um, what we did, you know, 1 year in. Um, it's reasonable to review your launch assumptions, um, check the channel mix. Um, and in our case, we had an increase in the Medicaid Channel, mix. So we've increased our reserves, um, for those rebates, um, and going forward, you know, that will that will kind of moderate itself. Um, we did have some returns, um, so we also looked at our rate of returns, um, and through that up and adjusted that, um, and increase that moderately. And then we did expand our GPO, um, contract business. Um, so we had some additional fees, um, this quarter, and we'll see those going forward. Also, but but we still feel confident that we'll be in the mid to high teens going forward. Great. Great yeah. Yeah no. Hi. Tara thanks for the questions. Um yeah I mean you you'll see basically what we're doing as well. There's a lot of reset and making sure that we

We have a, a strong base, you know, going forward, um, regarding your question about the demand side. I mean, it is a 3%. That's the, you know, kind of the accurate number, I agree with you. It's flattish given that our Base number of patients, you know, where we are. A few patients, can make a difference 1 way or the other. So, you know keeping that in mind, um, what we're seeing is that, you know, we are getting new patients, but the discontinuation of patients who existed or who came in on the brand, you know, they're really later line patients. And unfortunately, those patients are, you know, much more beaten up and they don't stay on therapy for, for very long. So, you know what, we really want to make sure that we are doing, is we're getting the right patients up front in the early setting. And that's, that's going to happen by really driving the education, the brand awareness, and the additional, you know, actions we're taking Beyond just sending in a rep, um, that that kind of, where we believe that, you know,

By doing this surround sound, uh, that can drive the right, uh, patients to start on therapy. Um, and that's where we're saying we have work to do on that part, uh, where we're, uh, well, you know, so that's the focus area that we have.

Okay, great surround sound. I, I like that. Thanks everyone. Yeah.

The next question comes from, Stephen Wy with steeple, your line is open.

Yeah, good morning. Thanks for taking the question. Um, I guess you talked about the growth in ordering accounts, I think 15% sequentially. Do we know anything about just the breadth of prescribing at this point and how many of those ordering accounts have either already written the script, um, and/or are new to the brand and they just have a follow-up?

Yeah, good morning, Steve. Thanks for the question. Yeah, I mean we're we're pleased to see The Continuous increase and the number of new accounts coming on board. So, you know, another 150 accounts have uh, have ordered, right? Hello. And this quarter versus last quarter, so that puts us this year to, you know, more than 500 new accounts ordering, right, right. Hello versus last year. Uh, so that red of, um, of, you know, folks getting on board, you know, we're pleased with that. I think that the work we have is making sure the depth is there. Uh, and the right patients are the ones who are being put namely, you know, earlier lines of patience. So repeat business was about, you know, 80% of accounts have reordered in the last, you know, quarter? So that's that's you know,

Okay, that's helpful. And then. Um do you have any idea what average duration of therapy looks like, at this point I know you're talking about used primarily occurring in these lateral line patience. I know the label calls for 6 Cycles um

I guess at a minimum, I'm just curious what you're seeing if anything on the on the duration of therapy side. Thanks.

Yeah, thank you Steve. What we have said is in real world, we're seeing uh, that the therapy duration, uh, in line with immerge in a similar patient population. So keeping in mind that in image, there were predominantly more second line patients and then the real world there is more third, fourth, fifth line patients. That's where the difference is happening. So, you know, that's where we want to make sure that we continue to encourage Physicians to use, right? ELO and earlier lines of therapy to really mimic what we're seeing in imerge and Beyond. Because currently, it's, it's apples to oranges. And I emerges, most second line and in real world is more, you know, third fourth line, which is shorter than that, 8 months that we've seen in, I work,

Understood. Thanks for taking the questions.

Thank you, Steve.

The next question comes from Karen Johnson, with Goldman Sachs, your line is open.

Hi. Uh, this is Eneba on behalf of Kin. Uh, maybe you can talk about the revised operating expense guidance for the year? Where are you finding the savings or the efficiencies in the budget? And what should we expect with respect to the OPC cadence for the next year?

Yeah, yeah. Um, thanks so I mean we're not giving Guidance just yet for 2026 full year. Um spend but for 2025 in the past I have mentioned that we have levers to pull particularly around some of our CNC CMC Investments. Um and we've also um slowed down just some of the infrastructure, you know organizational infrastructure Investments are related to it systems um and we were able to to pull in um you know our our full year Opex this year to um to the 250 to 260. So we feel pretty confident in those numbers.

Okay, thank you.

The next question comes from Evelyn bodnar with HC Wayne Wright. Your line is open.

Hi, thanks for taking the questions. Um, I had 1 on your sales force, I believe a few quarters ago you mentioned that you would have the sales force fully hired by the third quarter. So I'm curious if that's been completed and also any commentary you can give on what metrics you're using to evaluate the sales force and kind of their impact on demand Generation. Um and also if you can give an update on your EU partner search, if that's still ongoing. Thanks.

Thank you, Emily. Uh, good question. So yes, we have reported last quarter that we have hired our Field Force, and I would say our customer engagement folks because it was beyond just the commercial people. We also doubled our msl's in the field. So, both have been, uh, done in the last quarter. The training has happened over the summer time and now we do have an effective, uh, you know, customer engagement folks, both on the commercial side and also on the medical side where the focus has. Now, been is not just on the number of bodies that we have, but on the effectiveness of all the customer-facing folks, and then, you know, with the head office people to really be effective to be outcomes focused um, rather than activity focused. So, there's quite a bit of work happening. In the background on the operational excellence.

Own efforts. We're focusing on the US but then also making sure that we having the dialogue uh with appropriate potential Partners uh in Europe and Beyond as the whole idea. Is that right? Hello. We believe needs to be everywhere, helping patients across the world. We don't need to be everywhere uh as as, as a as a general ourselves. So those conversations are happening as we speak but, you know, we're um, we we we want to make sure that it's the right people. It's the right timing. Uh, you know, we are always, you know, having the patient uh, in mind. So we're pleased to start seeing that we have, you know, our first name patient, um, you know, sales happening in Germany but but we will make sure that it's really the appropriate setup, whatever we come up with uh especially now that we have you know half of the LT is new. And there's a reset that we're doing internally and ensuring that we have the appropriate.

In a conversations given how much Collective? Uh, partnership, uh, you know, opportunities, we have across the world so stay tuned on that, that that's ongoing. Um, and we will update the market as, as we have new updates.

Sure, thank you.

Thank you, Emily.

Once again, if you have a question or follow-up question, it is star 1 on your telephone keypad.

Your next question comes from facel, khurshida.

Hey, thanks for taking the question. Um, just wanted to ask. If you could sort of characterize, your level of confidence that you figured out, uh, what the issues are and that you truly believe that awareness, uh, is the main level to pull here. All right? And then also, if you have any updated views on the timeline to see, um, you know, return to growth here based on your efforts and expanded Field Force.

Yeah, thank you, fisel. Uh, I mean, look, we will not be here if we don't have confidence. I mean, we have very high confidence. I personally have high confidence and every leader who is here has high confidence, uh, be it. You know, newly joined or, you know, folks who've been here and who really, you know, believe in, right fellows. So, uh, confidence is definitely there. It's a prerequisite, but that's not enough fisel, right? Uh, positive thinking is not where we're going. We really are, you know, focused on execution of key areas uh, such as brand awareness. I mean, that that's 1 of the prerequisites in my opinion, at least that, you know, we want to make sure that more and more hematologists. When asked, do you know, right? Hello in lower risk MDS, the answer is yes.

We want to make sure that you know Physicians know how to use it, uh be it on the academic centers or be it in the community.

That's why we're really increasing our search on the ists because, you know, having Hands-On uh, experience with a drug like catalog by our us. Hematologist is an important aspect of what we do at the same time, on the community level. We want to make sure that our committee Physicians who are dealing with all kinds of different hematology and oncology. You know, situations and lower risk. MDS, might not be the largest pool of patients. They have that they are able to effectively select the right patients and put them on the right therapy manage the first couple of cycles of the Adverse Events so that they can get to the efficacy that we've seen in I merge and others. So from a confidence perspective as a uh, we definitely have the confidence, but beyond the confidence, we do believe we have the right identification of the diagnosis and some of the key programs that are now in place and we look forward to, you know, continuing

Continue to update the market on that at the same time. We are saying that these things do take time. I mean it's just it just is and uh there's nothing wrong with that, it just it does take time. So we want to be also very open in terms of these are not like switch moments. Um, we have the cash, we have the people, we have the plans,

And we look forward to updating you. As we start expanding our demand,

And then, do you have a, a timeline that you're willing to kind of guide the street? I don't know when we should expect growth.

A girl story over there but we're not getting any specific guidelines in terms of, you know, is it going to start growing on March 31 or you know if for 15 that that's not what we're saying. But we are very confident about the trajectory and as you're seeing, I mean this has been a very important quarter to really level set many of the things that we need to do uh to ensure that we're doing the right things and then over time growing the demand appropriately.

Appreciate it. Thank you.

Thank you. Bye.

This concludes the question and answer session and we'll conclude today's conference call. We thank you all for joining. You may now disconnect