Geron Corporation

Good morning, my name is Audra and I will be your conference operator today. At this time, I would like to welcome everyone to the Jerron Corporation third quarter 2023 earnings conference call. Today's conference is being recorded. 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 the star key followed by the number one on your telephone keypad. If you would like to withdraw your question, press star one again. At this time, I would like to turn the conference over to Erin Feingold, VP of Investor Relations and Corporate Communications. Please go ahead.

Good morning, everyone. Welcome to the Geron Corporation third quarter 2023 earnings conference call. I am Erin Feingold, Geron's Vice President of Investor Relations and Corporate Communications. I'm joined today by several members of Geron's management team. Dr. John Scarlett, Chairman and Chief Executive Officer. Michelle Robertson, Executive Vice President and Chief Financial Officer. Dr. Fay Feller, Executive Vice President and Chief Medical Officer. Anil Kapoor, Executive Vice President of Corporate Strategy and Chief Commercial Officer. And Dr. Andrew Gresslein, 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 the Mattel Stat, 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 quarterly report on Form 10-Q for the quarter ended September 30, 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. With that, I'll turn the call over to Chip.

Chip? Thanks, Erin. Good morning, everyone. Thanks for joining us today. This quarter, we continue to make important progress and build momentum along our planned path to develop and commercialize Imatelstab, our first-in-class tomorace inhibitor. This path, we believe, represents a great opportunity for both near- and longer-term value creation. 2023 has been a signal year for us, The Imatel-Stat MDA for the treatment of transfusion-dependent anemia in patients with lower-risk MDS was submitted and subsequently accepted for FDA review in August. The FDA assigned a PDUFA action date of June 16th of 2024. This was followed by validation of the MAA for the same indication in September of this year. Now that our MAA is under review, we expect the earliest potential approval could occur in late 2024 with a European launch potentially in 2025. We are continuing to evaluate our strategic options, including self-commercialization or partnering, and expect to be able to provide an update later in 2024. If approved, we believe the Imatelstat commercial opportunity in this indication is both differentiated and compelling for three reasons. First, Imatelstat's been shown to be highly effective in several key patient subgroups, where today's available treatments do not satisfactorily address the needs of patients with this disease. These include RS negative patients, patients with high transfusion burdens, and patients with high serum EPO levels. These key clinical attributes of Imatelstat have been further reinforced by the ASH abstracts published this morning. New analyses using data from the Phase III eMERGE trial in transfusion-dependent lower-risk MDS continue to show a significant durability, and breadth of transfusion independence across subgroups, including patients whose needs are not being met by current treatments. Second, there's a very large market opportunity for Imatelstat in lower-risk MDS patients with transfusion-dependent anemia, which we estimate represents a total addressable market, or TAM, of approximately $3.5 billion by 2033 in the U.S. and the EU for as well as the U.K. And third, this is a market that's seen low competitive intensity and relatively little innovation in the last decade. Despite the recently approved luspatercept label expansion, just last month, the National Comprehensive Cancer Network, or NCCN, published a revised version of its MDS guidelines, which still point to limited treatment options available to hematologists as they manage their transfusion-dependent lower-risk MDS patients. Moving beyond lower-risk MDS, another key component in Geron's path to value creation is an expected interim analysis in eMERGE, which is a Phase III study in JAK-I relapsed and refractory MF that's currently anticipated in the first half of 2025. IMPACT-MF is the first and only 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 relapsed refractory MF, which also represents an underserved, very substantial market opportunity with an estimated $3.5 billion TAM by 2033. Together, our lead indications represent a potential TAM of $7 billion in 2033. And beyond that, we continue to investigate the potential of Imatelstat and other hematologic malignancy indications and combination trials that could build additional value for the company. Given that opportunity, we've been preparing at an enterprise level for transitioning to a commercial company for several years. This has enabled us to efficiently hire and onboard our commercial and medical affairs leadership teams, scale our internal systems and operations, and build the competencies needed to succeed as a commercial company. Anil will speak further to the commercial opportunity later during this call. We also have a strong cash position of approximately $382 million at the end of the quarter, which based on our current plans and expected available resources, we expect will enable us to fund a potential successful launch in transfusion-dependent lower-risk MDS in the U.S., and fund our planned operations through the end of the third quarter of 2025. Finally, we have outstanding individuals to lead our organization through this transformation from a development stage to a commercial company. These individuals now include Michelle Robertson, who we recently appointed as CFO following the retirement of our longtime CFO, Olivia Bloom. We're thrilled to have Michelle on board at this very important moment in our history. Michelle brings with her over 30 years of financial and commercial operations experience, most recently a CFO of Editas Medicine and before that a CFO of Momenta before its acquisition by J&J. She also spent over 13 years in the finance and commercial operations group at Genzyme. Her deep command of financial operations, her experience with managing the financial and organizational needs of a biotech company preparing to potentially launch its first commercial product, And her prior experience with investors, analysts, investment bankers, as well as her hands-on experiences with commercial launches in the past will all be extremely valuable to our organization going forward. With that, I'll turn the call over to Faye for a regulatory and clinical update.