Geron Corporation

like to ask a question during this time, please press star 1 on your telephone keypad. I would now like to turn the call over to Dawn Scholdant, Senior Vice President, Investor Relations and Corporate Affairs. You may begin.

Good morning, everyone. Welcome to the Geron Corporation third quarter 2025 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 Ritello, anticipated clinical and commercial events, and related timelines. The sufficiency of general 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 Jaron'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. Jaron undertakes no duty or obligation to update our forward-looking statements. Joining me on today's call are several members of Jaron's management team. Harut Samarjian, Chief Executive Officer, Michelle Robertson, Chief Financial Officer, and Dr. Joseph Ede, 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 Harut, I'd like to say I'm truly energized to join Geront. This is a company that can change the lives of patients with blood cancers. The work ahead of us is real, but in my three weeks here, my confidence in our ability to deliver has grown every day. With that, I'll turn the call over to Haruth.

Thank you, Dawn, and good morning, everyone. I'm very excited to be hosting my first earnings call as CEO of Geron. On this call, we will provide a commercial overview, an update on medical affairs and our pipeline, and end with an overview of our financials. 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 and low risk MDS. Over these past months, I've been deeply impressed by the strength and dedication of our organization. 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 Ritello to more lower-risk MDS patients. Let me share four reasons that support our belief. First, Ritello 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. Low-risk MDS is an area of high unmet need with few, if any, potential treatments being studied in the clinic that can provide the differentiation that Ritello can as a telomase inhibitor. There is a clear opportunity for Ritello to be an important therapeutic option in low-risk MDS. Third, there is an opportunity to accelerate growth with the right strategy and improve execution. And fourth, the company is well capitalized. We have a strong cash position, which we believe is sufficient to support the robust commercial and medical affairs engagement needed to increase Rythello utilization. Now, let me provide you with an overview of our Q3 commercial performance. Net product revenue was $47.2 million for the third quarter. During the quarter, Demand for Ritello was down 3% compared to last quarter. New patient starts in first and second line increased to 36% compared to 30% in Q2. However, new patient starts did not offset the discontinuations we saw from patients using Ritello in later lines. It is clear we have work to do on establishing Ritello as a second line therapy in eligible patients with low-risk MDS patients. and educating HCPs on treatment management. Prescribing accounts increased by 15% in the quarter, with approximately 150 new ordering accounts added in Q3, expanding our footprint to 1,150 accounts. Lastly, we completed the first shipment of Ritello to Germany under a named patient early access program. We're preparing for the planned commercialization of Ritello in select EU markets in 2026. Q3 was an important quarter for us as we took stock of what we need to do to ensure Ritello reaches more patients. 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 Ritello. 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. He brings a wealth of expertise to Geron to execute a strong commercial strategy to support Rytello Growth. With the recently announced additions to the executive leadership team, along with existing team members, we can realign to accelerate momentum and grow Rytello. I'm confident we can realize the full value of Rytello and build a bright future for Geron. We believe Geron and Rytello 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. First, we need to substantially increase awareness for Ritello among US HCPs 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. This is especially critical when HCP prescribes Ritello to the first few patients. Our field-based commercial and medical colleagues have sharpened their approach to customer engagement aimed at educating HCPs on how to use Ritello, identifying the appropriate patients to start therapy, expanding reach into community sites, improving conversions and retention, and effectively managing patients on therapy. We believe over time this push to increase awareness for Ritello will grow our U.S. prescriber base and drive sales in the US. 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 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 Hematologic Oncology Conference in September in Houston. 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 Jerron's external perception. We received anecdotal feedback that more physicians are beginning to shift their thinking on Ritello, 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 retinal utilization. Lastly, we're excited to expand our ISD program with U.S. clinical sites and HCPs to address additional key medical questions about potential uses of imetastat and the benefits of telomerase inhibition. The iMERGE trial predominantly enrolled sites in Europe, we have work to do to collaborate with U.S. HCPs and give them opportunities for additional research with imitastat. These initial initiatives are just the beginning as we expect to identify additional opportunities to improve execution in the near term. It is important to recognize that the pull-through of the improved execution to revenue growth will take time. As for additional utility of Ritello, We recently completed enrollment in our IMPACT-MS Phase III clinical trial, evaluating imetastat and relapsed refractory myofibrosis. We currently project the interim analysis to occur in the second half of 2026, with final analysis projected in the second half of 2028. Our base case is for the trial to run to the final analysis as is the case for the majority of trials with overall survival as the primary endpoint. Should we see an opportunity to help patients with data from the interim analysis, we will be ready to explore the next steps rapidly. Success in myofibrosis could double our addressable patient population. Finally, before handing it over to Joe, I want to reiterate my optimism in Geron's future. Our priorities are clear. We're working to maximize the impact of Rite Hello for patients today while advancing our first-in-class telomerase inhibitor to benefit more people tomorrow. With that, I'll now hand the call to Joe to review clinical and medical affairs progress.