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| Statement |
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| The Lancet published results from our IMerge Phase 3 trial this past December, a strong validation of the importance of the study within the field, as well as a powerful way to reach hematologists and other providers globally with these potentially practice-changing results that offer the possibility of relief for lower-risk MDS patients from chronic reliance on blood cell transfusions |
| I'm very excited by the caliber of talent we have recruited onto the commercial team and across the organization |
| This growing body of data from the trial continue to give us confidence in what we believe is a meaningful clinical benefit and manageable safety profile with imetelstat in patients with transfusion-dependent lower risk MDS |
| The publications from our pivotal IMerge Phase 3 clinical trial, including most recently in The Lancet, show a robust response rate and an unprecedented durability of red blood cell transfusion independence with imetelstat treatment across multiple MDS patient subgroups addressing areas of high unmet need |
| And when we also provide context on the mechanism of action, this is something that's received very favorably by the practicing hematologists |
| In addition, we're excited by the momentum in our Phase 3 IMpactMF trial, which is 50% enrolled as of November 2023 and for which we expect an interim analysis in the first half of 2025 |
| We are excited about the opportunity to bring this innovative therapy to patients and are confident in our readiness to launch imetelstat in the US market upon potential FDA approval |
| We believe this is a robust commercial opportunity, and we're on track for a successful transition to becoming a commercial company |
| With a well-characterized safety profile of generally manageable and short-lived thrombocytopenia and neutropenia, we believe the clinical evidence supporting the benefits of imetelstat is compelling and that it can become a transformational treatment option for currently underserved populations if approved by regulatory authorities |
| We believe our differentiated product candidates, the very important commercial opportunities in transfusion dependent low risk MDS and relapse/refractory MF, the excellence and experience of our employees, and the financial resources to execute on our near-term milestones, puts us in a strong position for value creation |
| If we don't do it, some people somewhere in the world will start to do it on their own, and we would, we think we know the drug, we've helped that better than anybody else and we have control of that |
| With imetelstat in particular, what is really important is, which they receive really favorably, is the predictability of the cytopenias, the fact that the cytopenias typically are of finite duration and tend to go away in by cycles two and cycle three |
| And I have to say they did a wonderful job |
| I am personally excited to have the opportunity to discuss imetelstat with experts and peers as we believe imetelstat could be an important and compelling new medicine for transfusion dependent, low-risk MDS patients |
| Geron's progress and execution throughout 2023 has paved the way for a potentially transformational 2024 as we plan for the transition to becoming a commercial company |
| We're focused on and prepared for these critical next steps in the regulatory review process, which we hope will result in approval of what we believe is a highly differentiated and important treatment option for patients with transfusion-dependent lower-risk MDS |
| Lastly, we ended 2023 with a strong cash position of approximately $378 million, which based on our current plans and expected available resources, we expect will enable us to fund a potential successful launch in transfusion dependent low risk MDS in the US and fund our planned operations into the third quarter of 2025 |
| The conclusion on that letter was positive overall for imetelstat |
| B, we hope to be able to actually have ultimately improved efficacy, although this study is predominantly a safety study |
| And it's given us the ability to really interrogate the frequency and the sort of the course of these side of things, which as you know are indeed short-lived and well-managed |
| We feel very well prepared for the scheduled ODAC |
| Today we're just 3.5 months away from the PDUFA date for our first-in-class telomerase inhibitor, which we believe has the potential to offer important and potentially life-changing treatment options to patients with transfusion-dependent lower risk MDS |
| Our cross-functional launch teams have deep oncology expertise and operational experiences, and they have been part of multiple oncology launches |
| They're very, very well known to many people in the industry, experts on drug abuse, liver injury, etc |
| As reported at these conferences, the clinical attributes of imetelstat were differentiated, particularly with respect to high RBCTI response rate, durability of response, and the consistency of effect across MDS subgroups that have historically been very difficult to treat |
| Our two lead indications for imetelstat represent significant commercial opportunities with a total addressable market or TAM of $3.5 billion for each indication across the US and EU in 2031, thus representing a combined $7 billion TAM for transfusion-dependent low risk MDS and relapsed/refractory MF |
| This patient population is extremely underserved and every feedback from physicians, academic experts, leading KOLs, is that if our myelofibrosis study is positive, it is going to be transformative for patients with myelofibrosis and really will be rapidly well adopted within the space |
| We are very pleased with the progress and look forward to providing future updates |
| Our readout of positive top-line results from our pivotal IMerge trial in January 2023 was followed last year by a number of additional presentations and analyses of the data, including at ASCO and EHA earlier in the year and last quarter at ASH |
| Physicians tell us they have deep experiences with drugs such as len HMAs and are very adept at managing heme-related side effects for patients |
| Statement |
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| RS-negative patients make up approximately 75% of lower risk MDS patients and are a population particularly vulnerable to poor clinical outcomes |
| And what we see is that if you end up treating with [indiscernible] you see any damage |
| I was on mute |
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