Geron Corporation

Good morning, my name is Rob and I will be your conference operator today at this time, I would like to welcome everyone to the geron corporations fourth quarter and full year 2023 conference call. All lines have been placed on mute to prevent any background noise after the speakers remarks, there will be a question and answer session. If you'd like to ask a question during this time simply press star followed by the number one on your telephone keypad if you would like to withdraw your question again press the star one. Thank you. Erin Feingold, Vice President of Investor Relations and Corporate Communications. You may begin your conference.

Good morning, everyone. Welcome to the Jaron Corporation fourth quarter and full year 2023 earnings conference call. I am Erin Feingold, Jaron's Vice President of Investor Relations and Corporate Communications. I'm joined today by several members of Jaron's management team. Dr. John Scarlett, Chairman and Chief Executive Officer. Michelle Robertson, Executive Vice President and Chief Financial Officer. Dr. Faye Feller, Executive Vice President and Chief Medical Officer. Anil Kapoor, Executive Vice President of Corporate Strategy and Chief Commercial Officer. And Dr. Andrew Gressline, Executive Vice President and Chief Operating Officer. 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 therapeutic potential and potential regulatory approval of an adult that anticipated clinical and commercial events and related timelines, the sufficiency of geron 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 Jerron'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 statement. Jerron undertakes no duty or obligation to update our forward-looking statement. With that, I'll turn the call over to Chip.

Chip? Thanks, Aaron. Good morning, everyone. Thanks for joining us today. JIRAN'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. FDA has assigned a PDUFA date of June 16, 2024 for IMITEL staff for the treatment of transfusion-dependent anemia in patients with lower-risk MDS, and has also provided notice that it's scheduled an ODAC as part of the Immatel-Stadt MDA review to be held on March 14, 2024. In addition, a review of our MAA for the same indication is expected to be completed in early 2025. 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. The publications from our pivotal eMERGE Phase III clinical trial, including most recently in the Lancet, show a robust response rate and an unprecedented durability of red blood cell transfusion independence with Imatel-Stat treatment across multiple MDS patient subgroups, addressing areas of high unmet need. Additional unique attributes of Imatel-Stat include patient-reported outcomes of less fatigue, and significant reductions in variant allele frequency in commonly mutated MDSG. With a well-characterized safety profile of generally manageable and short-lived thrombocytopenia and neutropenia, we believe the clinical evidence supporting the benefits of Imatelstat is compelling and that it can become a transformational treatment option for currently underserved populations if approved by regulatory authorities. Behind our lead indication in low-risk MDS is a similarly important program, the Phase III IMPACT-MF clinical trial in JAKI relapsed and refractory myelofibrosis. An interim analysis is expected for this study in the first half of 2025. IMPACT-MF is the first and only MF Phase III trial with overall survival as a primary endpoint. If the expected interim analysis in 2025 or the final analysis expected in 2026 is positive, these data could be transformational for patients with JAKI relapse and refractory MF who have dismal survival prognoses today. Our two lead indications for Imatelstat 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 lower-risk MDS and relapsed-retractory MS. Given this very substantial opportunity, amid a deep unmet need in transfusion-dependent lower-risk MDS, we expect to be prepared to launch and self-commercialize Imatelstat in its lead indication upon potential FDA approval in the middle of this year. We have also completed multiple long lead activities to prepare Giron, Imatelstat, and the market for our potential launch in the US, with the goal of ensuring broad access and reimbursement for our important medicine. Moreover, if Imatel stat is approved by the European Commission in transfusion-dependent lower-risk MDS, we expect commercial launch in Europe would occur in 2025. We're continuing to evaluate our strategic options for European commercialization, including self-commercialization or partnering, and expect to be able to provide an update later this year. lastly we ended 2023 with a strong cash position of approximately 378 million dollars which based on our current plans and expected available resources we expect will enable us to fund a potential successful launch and transfusion dependent lower risk mds in the u.s and fund our planned operations into the third quarter of 2025. we believe our differentiated product candidates, the very important commercial opportunities in transfusion-dependent lower-risk MDS and relapsed refractory MS, 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. With that, I'll turn the call over to Faye for a regulatory and clinical update. Faye?