Geron Corporation

and Corporate Communications. You may begin.

Good morning, everyone. Welcome to the Jaron Corporation Third Quarter 2024 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. Jim Ziegler, Executive Vice President and Chief Commercial Officer, Dr. Faye Feller, Executive Vice President and Chief Medical Officer, and Dr. Andrew Grefline, 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 launch, commercial opportunity, and therapeutic potential of Britello, 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 statements and our future updates to those risk factors. Jerron undertakes no duty or obligation to update our forward-looking statements. With that, I'll turn the call over to Chip. Chip?

Thanks, Erin. Good morning to everybody on the call. Thanks for joining us today. Following FDA approval and the commercial launch of Rytello, our first-in-class telomerase inhibitor, this has been a transformative year for Geron. As a result, we believe we're well positioned to build long-term commercial value with this product. In our first full quarter on the market in the United States, we achieved $28.2 million in Rytello net product revenue, which exceeded our expectations. The initial quarter of product revenue speaks to our execution as a commercial company, as well as the high unmet need in lower-risk MPS and the compelling value proposition of Rytello for hematologists and patients. This gives us confidence in future continued demand and momentum for Rytello. Our strong IP position underlies the long-term commercial value proposition for Rytello. We believe this IP position, including specific claims and our patents, covering the indication that's in our FDA label, and buttressed by the FDA's grant of orphan drug exclusivity for lower-risk MDS into June of 2031, will provide exclusivity in the United States through August of 2037. Today, our primary focus is on continuing to deliver on the initial success we achieved in the third quarter, getting Reiteller to more eligible lower-risk MDS patients and maximizing our opportunity in the U.S. market. In Europe, we believe that the CHMP review of our Raytello marketing authorization application in lower risk MDS could be completed in late 2024 or early 2025 with potential EU approval in the first half of 2025. Subject to receiving this approval, we're continuing to prepare for the potential launch of Raytello in the EU. and are planning to commercialize Rytello in select EU markets beginning in 2026. As all of you know, Jim Ziegler joined us as Chief Commercial Officer in early September. Jim hit the ground running, and on this call, will provide more color on the third quarter U.S. commercial launch performance, key imperatives for our continued success, and our next steps in preparing for potential EU commercialization. In addition to this quarter's strong commercial performance, we were pleased to announce this morning a completion of both the synthetic royalty transaction and a debt financing transaction that together generated $250 million in gross proceeds. These transactions were comprised of $125 million capped synthetic royalty with Royalty Pharma, and a $250 million committed senior secure debt facility with funds managed by Pharmacon Advisors, under which we've borrowed $125 million, allowing us to retire existing debt. With this new debt facility, we also have access to an additional $125 million. We believe that the favorable terms we achieved in these transactions reflect the significant commercial potential of Ritello And coming off a successful first quarter of commercial launch, provide us with critical flexibility to fuel continued growth and investment in our future. Michelle will provide more details on these transactions and on our Q3 results later on this call. Let's move on to our commercial development programs. Starting with our Pivotal ImatelSTAT Phase III Impact MF Trial and JAK Inhibitor Relapse Refractory Myelofibrosis, This trial was approximately 70% enrolled as of August 2024. Based on the most recent planning assumptions for enrollment and death rates in the trial, we continue to expect an interim analysis in early 2026, as well as a final analysis in early 2017. As the first myelofibrosis phase three trial with overall survival as the primary endpoint, we believe that if the trial is positive, Imatelstat could transform the treatment landscape for this high-end met need patient population with dismal survival, representing a substantial commercial opportunity. In addition to ImpactMF, we are exploring the potential of Imatelstat across multiple different myeloid hematologic malignancies, which were highlighted in ASHA abstracts that were released earlier this week. Faye will speak to the new data and to our earlier clinical programs later in the call. Finally, I'd like to highlight the very significant contributions from our colleagues across the company in these first four months of our launch. They executed against our key business objectives with focus and a sense of urgency to deliver Rytela to the patients we're committed to help. We deeply appreciate this commitment as we continue our evolution as a commercial company Looking forward to the future. With that, I'll hand the call over to Jim for a commercial update. Jim?