Geron Corporation

Good afternoon. My name is Emma, and I will be your conference operator today. At this time, I would like to welcome everyone to the Geron Corporation's fourth quarter and full year 2022 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, VP of Investor Relations and Corporate Communications. You may begin your conference.

Good afternoon, everyone. Welcome to the Geron Corporation Fourth Quarter and Year-End 2022 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 Imatelstat, 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 Annual Report on Form 10-K for the year ended December 31, 2022, 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 fourth quarter and annual 2022 financial results, as well as business updates and expected upcoming key milestones. The agenda for today's conference call will be as follows. Chip will provide introductory remarks. Faye will highlight key data from the recent top line results from iMerge Phase 3 and provide a status update on our regulatory plans. She will also discuss our other ongoing development programs. Anil will discuss this year's planned commercial preparedness activities. Olivia will review fourth quarter and year-end 2022 financial results, financial guidance for 2023, and current capital resources. And Chip will provide concluding remarks before going to the Q&A session. With that, I will turn the call over to Chip. Chip?

Thanks, Erin. Good afternoon, everyone. Thanks for joining us today. With positive top-line results from eMERGE Phase 3 in hand, we now have a charted path towards several potentially significant regulatory and commercial catalysts, which we expect will further enhance the value of Imatel stats. Building on the momentum created by the lower risk MDS results, we are also advancing our pipeline to expand the potential applications from the Telstat and telomerase inhibition, which we envision will establish Geron as a leader in the treatment of hematologic malignancies. As a first step in the commercially attractive lower risk MDS indication, we remain on track to submit the NDA in mid 2023 and to complete the MAA submission in the second half of 2023. In parallel, we're preparing for potential U.S. commercial launch in the first half of 2024 and a potential EU launch by the end of 2024. We recently expanded our capabilities to support the potential commercialization of Immatelstat with the hiring of seasoned professionals with deep operational and launch experience. These individuals, who will serve on our growing senior commercial leadership team, include experts in trade and channel relations, market access, marketing, medical affairs, and sales. We believe that adding these colleagues to our already highly talented employee base provides the expertise and experience necessary to prepare for the anticipated commercial launch of the Mattelstat. A key differentiating quality of the Mattelstat and its novel telomerase inhibition mechanism of action is the potential to modify the course of the underlying hematologic malignancy. The compelling Phase III readout in lower-risk MDS has now added to our robust body of evidence of disease modification, and we believe our other clinical and research programs will further corroborate the potential meaningful clinical benefits with Imatelstat treatment. In our second Imatelstat Phase III trial, IMPACT-MF, a potential positive overall survival outcome could set the stage for changing the treatment landscape in myelopigrosis. Based on our current planning assumptions for enrollment and event rates, we expect an interim analysis for OS in IMPACT-MF in 2024. To further assess the potential of imetelcet and other hematologic malignancies, We're advancing development programs which evaluate Imatelstat in additional indications and in combination regimens. We expect significant readouts from these programs over the next several years. We have a strong balance sheet to fuel our regulatory, commercial, and Imatelstat development activities. On the heels of positive top-line results from our eMERGE Phase III study in low-risk MDS, we raised over $210 million in net proceeds from high-quality strategic investors in early January of this year. Combining our year-end cash balance with the net proceeds from the successful financing in January and the warrant exercise proceeds received in the first two months of this year, we accumulated total cash holdings in excess of $445 million. We believe that these capital resources will be sufficient to fund our projected operating requirements through the end of the third quarter of 2025, supporting the achievement of many of the value-accreting catalysts we're pursuing. In parallel with our continuing preparations to commercialize Imatelstat, we continue to consider relationships with potential partners, including exploration of regional and other deal structures of possible mutual interest, which could potentially maximize the value of Imatelstat for patients and Geron shareholders. In summary, the commercial preparedness and clinical development activities planned in 2023, as well as potential upcoming catalysts, are expected to position Geron to become a leader in the treatment of heme malignancies. Further, our strong financial position and highly capable employee base provides the foundation for Geron to become a fully integrated commercial biotech company over the next 15 months. With that, let me hand the call over to Fay Feller, our Chief Medical Officer.