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 Corporation's first quarter 2023 earnings conference call. All lines have been placed on mute to prevent any background noise. After the speaker's remarks, there will be a question and answer session. If you would 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, Investor Relations and Corporate Communications. You may begin your conference.

Good morning, everyone. Welcome to the Geron Corporation first quarter 2023 earnings conference call. I am Erin Feingold, Geron's Vice President of Investor Relations and Corporate Communications. I'm joined today by the following members of Geron's management team. Dr. John Scarlett, Chairman and Chief Executive Officer. Olivia Bloom, Executive Vice President and Chief Financial Officer. Dr. Fay Feller, Executive Vice President and Chief Medical Officer. And Anil Kapoor, Executive Vice President of Corporate Strategy and Chief Commercial 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 Immatel-STAT, anticipated clinical and commercial events, and related timelines, the sufficiency of Geron's financial resources, and other statements that are not historical fact. Actual events or results could differ materially. Therefore, I refer you to the discussion under the heading Risk Factors in Jerron's quarterly report on Form 10-Q for the quarter ended March 31, 2023, which identifies important factors that could cause actual results to differ materially from those contained in the forward-looking statements. Jerron undertakes no duty or obligation to update our forward-looking statements. Please refer to the press release and slide deck for today's call under events in the investors and media section of our website at www.geron.com slash investors for our first quarter 2023 financial results, as well as business highlights. The agenda for today's conference call will be as follows. Chip will provide introductory remarks. Faye will give a regulatory update, discuss key data accepted for presentation at ASCO and EHA, and provide a medical affairs update. Neil will highlight our progress and launch planning and provide an overview of the lower-risk MDS commercial opportunity, including physician insights and perceptions. Olivia will review first quarter 2023 financial results and current capital resources, and Chip will provide concluding remarks before going to a Q&A session. With that, I will turn the call over to Chip.

Chip? Thanks, Erin. Good morning, everyone. Thanks for joining us today. At Geron, we aim to transform the treatment of heme malignancies, which we believe will provide a significant, compelling commercial value proposition. In the Telstat, our first-in-class telomerase inhibitor is poised to become a highly differentiated standard of care in lower-risk MDS and in relapsed refractory myelofibrosis. In lower-risk MDS, this is based on our eMERGE Phase III data, which showed an unprecedented durability of transfusion independence, as well as the breadth of that Ti benefit across major MDS subtypes, including both RS positive and RS negative patients. No other drug we know of today can match this level of durability in this patient population. Imatelstat's activity in RS negative patients is particularly noteworthy because there is no approved agent today specifically for this patient population which represents about 75% of the patient opportunity in lower-risk MDS. In fact, these RS-negative patients generally are harder to treat compared to RS-positive patients and therefore critically require new treatment options. Unlike the current treatment options, Imatelstat has a novel mechanism of action as a telomerase inhibitor that confers strong clinical and molecular evidence for disease modification, as well as a well-defined safety profile of on-target cytopenias, seen in some patients that have limited clinical consequences. Fay will further discuss these data, which are featured in two abstracts accepted for oral presentation at EHA. Fay will also highlight another accepted EHA abstract that is based on patient-reported outcome data from eMERGE Phase 3. This abstract illustrates that compared to placebo, in a Telstat treated patients were more likely to have sustained meaningful improvement in fatigue and experience such improvements more quickly. Based on these compelling phase three data, we're on track to submit our new drug application to the FDA next month. The submission will include a request for priority review. Our goal is to be ready for a commercial launch in early 2024. We're planning for the US commercial launch to ensure broad reimbursement for Imatelstat and deliver a seamless customer experience to all stakeholders. Under Anil's leadership, we're taking a deeply integrated and cross-functional approach to prepare our product, the market, and our organization for commercialization, which Neil will elaborate on later in the call. After lower-risk MDS, Geron also has a significant follow-on indication in JAK-I relapsed refractory MF patients that's anchored by the first and only Phase III study that has a primary endpoint of overall survival. If that study reads out positively, we expect Imatelstat to become a transformational standard of care for these MF patients who today have very limited treatment options. We believe Imatelstat can address significant unmet needs for lower-risk MDS and relapsed refractory MF patients, leading to a potential total addressable market opportunity, or TAM, in the U.S. and EU of greater than $7 billion in 2033. About half of that TAM, or approximately $3.5 billion, is attributable to the lower-risk MDS indication. From a financial perspective, we have over $400 million on the balance sheet as of the first quarter close, which gives us the financial wherewithal to operate the company through the end of the third quarter of 2025. As such, we believe we're positioned to launch Imatelstat and lower-risk MDS, uncompromised by financial restraints. while also supporting the rest of our malignant hematology program, including the expected readout of our phase three overall survival study in relapsed refractory MF. I believe our unprecedented clinical data today, driven by our differentiated mechanism of action and potential for disease modification, together with a clear regulatory pathway, solid financial resources, and a highly experienced team, represent a winning combination to bring Imatelstat to the market as a potentially transformational treatment for patients. With that, let me hand the call over to Faye Feller, our Chief Medical Officer. Faye?