Geron Corporation

Hello and welcome to the GERON first quarter 2025 earnings 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, please press star 1 on your telephone keypad. I would now like to turn the conference over to Ron Moldaver, Investor Relations. You may begin.

Good morning, everyone. Welcome to the Jaron Corporation first 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 related to the launch, commercial opportunity, and therapeutic potential of Ritello, anticipated clinical and commercial events, and related timelines, the sufficiency of Jerron's 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 with the SEC, which identifies important factors that could cause actual results to differ materially from those contained in the forward-looking statement and our future updates to those risk factors. Geron undertakes no duty or obligation to update our forward-looking statements. With that, I'll turn the call over to Dawn Burr, Interim President and Chief Executive Officer.

Good morning. Thank you, Ron, and thank you all for joining us. I'll begin on slide four. I'm joined today by several members of Geron's management team. Michelle Robertson, our Chief Financial Officer, Jim Ziegler, our Chief Commercial Officer, and Dr. Joseph Ede, our Executive Vice President of Research and Development. Let's continue on the next slide. I'll begin by stating that Ritello U.S. commercial launch success is our number one corporate priority. Ritello is a first in class novel telomerase inhibitor recently approved for the treatment of certain patients with lower risk MDS, a disease with significant unmet need. We believe that there is a large U.S. market opportunity for Rytello, and Q1 sales were not where we expect them to be. Q1 Rytello net revenues were $39.4 million, down $8 million from Q4, while demand in the 13-week period through the week ending March 28th was relatively flat at plus 1% versus the prior 13 weeks. The lower quarter-over-quarter net revenue is due to the inventory drawdown among our distributors from Q4 into Q1. Michelle will address this in greater detail in our financial update. Personally, I stepped into this role because I'm excited by the opportunity to bring this important medicine to eligible patients and the healthcare community, and together with this leadership team, execute on this commercial opportunity and drive value for all involved. Today, we'll share key factors that we believe have influenced the recent soft performance, as well as specific enhancements we've made and continue to make to support U.S. commercial success. We expect our increased commercial investments to bolster uptake across a broader group of prescribers and drive long-term demand. Since our last earnings call, we've performed an in-depth analysis of our commercial efforts with the current market, And we're focused on three key strategies to integrate sales growth. First, we are investing additional resources to increase brand awareness among the highest decile US hematologists treating the greatest number of lower risk MDS patients today. Second, we're refining our marketing and medical efforts to enhance prescribing clarity and competence with the use of Ritello. articulating how and where to use it successfully as indicated in our approved label with the goal of supporting positive HCP and patient experiences and continued use. And third, we're implementing programs to expand US KOL support and advocacy through aligned messaging, education, and through both commercial and medical affairs engagement efforts. Today, Jim and Joe will share further details of specific commercial and medical affairs actions to implement these three key strategies. This includes refined HCP target identification, expanded sales and medical field headcount, and the addition of newly created goals to highlight only a few. We're confident that by intensifying our focus on the strong execution of launch fundamentals that we'll see performance trends moving in the right direction. and are encouraged by a few recent early performance indicators that we will share with you today. Success takes an organized team effort, and we've invested with deliberate attention and urgency to reinvigorate this launch. With our recent EU approval in March, we are pursuing what we believe is a targeted, disciplined path to make Ritello available to patients beyond the United States while being fiscally responsible. Our strategy is to work with experienced third parties to help minimize the investment needed outside of the United States, allowing our teams to focus on our top priority of driving our U.S. commercial efforts. We do not plan to commercialize in Europe or any other region outside of the United States independently. We're also excited about our late-stage clinical development program that could expand in MattelSTAT for use more broadly within hematology and continue to fill unmet needs. IMPACT-MF is our phase three pivotal trial evaluating imatelstat in relapsed refractory myelofibrosis with an endpoint of overall survival. If we're successful in this trial and imatelstat is approved in this setting, we believe that the opportunity exists to meaningfully expand and potentially double the commercial potential of Ritello. Joe will provide an update on enrollment and potential near-term milestones, including the interim analysis that is anticipated in the second half of next year. Before turning the call over to Jim, I will also mention that our process to identify a permanent chief executive officer is ongoing. Our board is working with an experienced executive search firm to identify and evaluate candidates with strong commercial leadership in our industry. We expect a decision to be made and announced within the next six months. With that, I'll hand the call over to Jim to provide a U.S. commercial update.