Geron Corporation

Thank you for standing by. My name is Jael and I will be your conference operator today. At this time, I would like to welcome everyone to the Geron Q1 2024 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, press star one again. I would now like to turn the conference over to Erin Feingold. You may begin.

Good morning, everyone. Welcome to the Geron Corporation first quarter 2024 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 Starlett, Chairman and Chief Executive Officer. Anil Kapoor, Executive Vice President of Corporate Strategy and Chief Commercial Officer. Dr. Faye Seller, Executive Vice President and Chief Medical Officer. Michelle Robertson, Executive Vice President and Chief Financial 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 MS HealthStats, anticipated clinical and commercial events and related timelines, the sufficiency of Jerron'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 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. Geron 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. We're poised for a successful U.S. launch of Imatelstat for the treatment of transfusion-dependent anemia in patients with lower-risk MDS. It's proved we're deeply excited for the opportunity to bring patients what we believe is an important and differentiated medicine. With our PDUFA date on June 16th, we continue to work closely with the FDA as they complete the review of our new drug application. As part of the MDA review process, on March 14th, the FDA's Oncology Drugs Advisory Committee, or ODAC, voted 12 to 2 in favor of the clinical benefit risk profile of Imatelstat for its intended indication in lower-risk MDS. The resounding support for Imatelstat reflected in the ODAC votes was also echoed in comments from the lower-risk MDS community during the public forum. Hematologists and patients alike spoke out about the burden of transfusion-dependent anemia in this disease and the need for new treatments, particularly for patients with difficult-to-treat subtypes such as high transfusion burden and RS-negative patients. Ametelstat is uniquely positioned to address these underserved transfusion-dependent MDS patient populations. We're in the final stages of commercial readiness execution, which is included bringing on a sales force in April 2024. We're also engaging in marketing, commercial access, payer, and reimbursement preparatory efforts, just as we are completing the build out of our enterprise capabilities and systems to support our transition to commercial stage company. In short, we're building on our momentum, acting with urgency, and fully confident in our readiness for a U.S. launch on potential approval. We're also financially well-resourced to support the planned U.S. commercial launch, with approximately $465 million on the balance sheet as of March the 31st of this year. On the heels of the highly positive ODAC outcome, we raised approximately $141 million in net proceeds from an underwritten public offering of common stock and a pre-funded warranty. This offering included participation from RE Capital, Fairmont, Orbamed, Farallon, Adage, Boxer, Vivo, DeepTrack, and multiple large investment management firms in addition to other new and existing investors. From an EU perspective, we also have an MAA or marketing authorization application under review in this indication. If Imatelstat is approved by the European Commission, we expect a 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 provide an update later this year. I'd like to turn briefly to our ongoing clinical development efforts in JAKI relapsed and refractory MS patients. As many of you will recall, ImpactMF is the only Phase III MF study with overall survival as the primary endpoint. Last month, the Data Monitoring Committee evaluated unblinded data and recommended the clinical trial continue. In addition, the company reviewed enrollment rates and blinded death rates, which are lower than anticipated based on the initial planning assumptions. Accordingly, we're updating our guidance to extend the timelines by half a year with the interim analysis now expected in early 2026 and the final analysis expected in early 2027. We in the trial investigators remain excited about this study and the potential of a treatment that could improve survival for these patients who currently have very few treatment options and dismal survival rates. They will provide more color on this trial later in the call. Before I turn the call over to the team, I'd like to take a moment to reflect on how inspired I've been by all of our gerund people. Their passion for bringing our medicine to patients is palpable and drives our culture. From our longest-tenured colleagues who worked on the Imatel-STAT IMD to our sales force that joined us just a few weeks ago, there is a deeply shared sense of purpose that each one of us can meaningfully contribute to improving the lives of patients with hemologic malignancies. I believe that this unity around our mission drives our urgency and collaboration, and it's a critical factor in transforming our fast-growing organization into a successful commercial company. With that, I'm going to turn the call over to Anil for a commercial update. Anil?