Geron Corporation

Good day and thank you for standing by and welcome to the Q1 2021 Chair and Earnings Conference call. At this time, all participants are in a listen-only mode. After the speaker's remarks, there will be a question and answer session. To ask a question during the session, you will need to press star 1 on your telephone. If you require any further assistance, please press star 0. I would now like to hand the conference over to your speaker today. Olivia Bloom, please go ahead.

Great. Thank you, Celine. And good afternoon, everyone. Welcome to this conference call to discuss Geron's first quarter 2021 financial results and recent company events. I am joined today by Dr. John Scarlett, Geron's chairman and chief executive officer, and Dr. Alexander Rizzo, Geron's chief medical officer. After the market closed today, we announced our first quarter 2021 financial results via press release, which is available on our website. In addition, an archive of this webcast will be available on our website for 30 days. Before we begin, please note that this presentation and question and answer session will contain forward-looking statements relating to Gerald's plans, expectations, timelines, beliefs, statements of potentiality, and projections. These include, without limitations, those regarding the expected timelines for completion of enrollment of and the results from the eMERGE Phase III and IMPACT-MS clinical trials and submission of an NDA, the potential for positive outcomes from eMERGE Phase III and IMPACT-MS, potential approval of MMIC health stats by regulatory authorities and its commercialization, The expectation that Jaron's current financial resources will be sufficient to fund operations until the end of 2022, and that its operating expense burn in 2021 will be between $108 million and $112 million, and that Imatel's set has the potential to be these modifying and alter the course of MDS and MF. These and the other four looking statements involve risks and insurgencies that can cause actual results to differ materially from those in such four looking statements. These risks and uncertainties include, without limitation, those regarding that the company may be unable to overcome all the enrollment, clinical, safety, efficacy, technical, scientific, operational, manufacturing, and regulatory challenges to meet the expected timelines for the Emerge Phase III and IMPACT-MS clinical trials due to COVID or otherwise. that in the Phase III clinical trials, Imatel-STAT may not prove to be as safe or efficacious as in the Phase II trials and may not demonstrate that it is safe, efficacious, and disease-modifying, that regulatory authorities may not permit the further development of Imatel-STAT on a timely basis or at all and may not approve it for commercialization, and that Geron may need additional financial resources before the end of 2022 for the development and commercialization of Imatel-STAT. Detailed information on the above risks and uncertainties and additional risks, uncertainties, and factors that could cause actual results to differ materially from those in the forward-looking statements are explained under the heading Risk Factors in Jerome's quarterly report on Form 10-Q for the quarter ended March 31, 2021, filed with the Securities and Exchange Commission. Undue reliance should not be placed on forward-looking statements which speak only as of the date they are made, and the facts and assumptions underlying the forward-looking statement may change. And now I will turn the call over to Dr. Scarlett. Chip?

Thanks, Olivia, and good afternoon, everyone. During the first quarter of 2021, we continued to make progress in our two Immatolstat Phase III studies with registrational intent. First, enrollment continues to increase in our ongoing eMERGE Phase 3 trial. This trial is evaluating imotelstat and transfusion-dependent lower-risk MDS patients who are relapsed or refractory to erythropoiesis-stimulating agents, or ESAs. Last December, we had completed half of the planned enrollment of 170 patients in this trial. I'm happy to report that as of today, we have now achieved 75% of the planned enrollment. We continue to expect this trial to be fully enrolled in the second half of this year and for top-line results to be available as early as the end of 2022 or in the first half of 2023. Next, in IMPACT-MF, our second Phase III trial, that's evaluating imitelstat in patients with intermediate to or high-risk myelofibrosis who are refractory to prior treatment with the JAK inhibitor, we recently announced the first patient being dosed. This trial is the first trial of its kind in refractory MF patients with overall survival as the primary endpoint. Based on our current planning assumptions, we continue to expect the planned enrollment of 320 patients for this trial to be complete in 2024. Next, we are progressing on our preliminary activities for NDA and commercial readiness, which include long lead time manufacturing and quality activities, as well as developing a comprehensive organizational foundation to support a high growth and commercial stage company. Lastly, we look forward to presenting new data and analyses from our phase two Imatel-STAT trials at the upcoming European Hematology Association meeting, EHA, with the two abstracts that we submitted. The abstracts will be available online at ehoweb.org on May the 12th. Looking ahead over the next three years, we remain committed to achieving top-line results in eMERGE Phase 3, gaining regulatory approval of Imatelstat, and commercially launching this highly differentiated drug in low-risk MDFs. With that, I'll turn the call over to Alexandra. Alexandra?