Geron Corporation

Ladies and gentlemen, thank you for standing by and welcome to the Q1 2020 Geron Earnings Conference Call. At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question and answer session. To ask a question during the session, you'll need to press star one on your telephone. If you require any further assistance, please press star zero. I would now like to hand the conference over to your speaker today, Head of Investor Relations, Suzanne Mafferi. Thank you, please go ahead.

Thank you, Chantel, and good afternoon, everyone. Thank you for joining us for today's conference call. I am joined today by Dr. John Scarlett, Jones Chairman and Chief Executive Officer, and Olivia Bloom, the company's Chief Financial Officer. Also joining me today are Alexandra Rizzo, our Chief Medical Officer, and Anil Kapoor, our Head of Corporate Strategy and Chief Commercial Officer. After the market closed Today, we announced our first quarter 2020 financial results via press release. It is available on our website under www.geron.com slash investors, as well as several other press releases announcing recent developments in the month of May. In addition, a live webcast of the call is available on our website and will be archived for 30 days. Before we begin, please note that this presentation and question and answer session will contain forward-looking statements relating to GERON's plans, expectations, timelines, beliefs, statements of potentiality, and projections. These include, without limitation, those regarding the timelines for completion of enrollment of and the results from the ongoing Phase III eMERGE and planned refractory MF clinical trials, that GERON's existing financial resources will be sufficient to fund operations into the second half of 2022, potential revenues, and that Jaron's 2020 operating expense burn will be in the range of 70 to $75 million. These and other forward-looking statements involve risks and uncertainties that can cause actual results to differ materially from those in such forward-looking statements. These risks and uncertainties include, without limitation, those regarding that the company may be able to overcome all the clinical, safety, for their advocacy, technical, scientific, operational, manufacturing, and regulatory challenges to enable the expected timelines for the eMERGE and CLAND refractory MF clinical trials. That regulatory authorities may not permit the further development of Immatelsta on a timely basis or at all. That the COVID-19 pandemic may significantly impact the timelines for both the enrollment and the results of the clinical trials and or drug supply. that competition or other factors result in lower than projected revenues and that there may be unexpected operating expenses or events or changes in John's plans that cause the 70 to 75 million 2020 financial guidance to be revised. 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 Jaron's quarterly report on Form 10-Q for the quarter ended March 31, 2020, filed with the SEC. 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 statements may change. I will now turn the call over to Dr. John Scarlett, Jaron's Chairman and CEO. Chip?

Thank you, Suzanne. I'd like to welcome everyone to our first quarter 2020 conference call. On today's call, I'll have some introductory remarks. Olivia will cover Q1 results, 2020 guidance, and the recent financing, and Alexandra will discuss recently announced clinical development activities in MF and MDS. To start our call today, I'd like to share with you my conviction that Geron today is a fundamentally different company. It's a company in which all the pieces necessary to become a leader in the treatment of hematologic myeloid malignancies are now in place. We have a novel drug and a unique target. Meaningful clinical activity and indications with significant unmet need. Two phase three trials, one ongoing and another planned, both based on compelling phase two data. A highly experienced team to execute all aspects of drug development. and financial resources to reach significant value inflection points. We've known for many years that Imatelstat has a unique mechanism of action. In malignant stem, progenitor and blood cells, telomerase is continuously upregulated resulting in malignant hematopoiesis. Imatelstat selectively targets malignant cells with continuously upregulated telomerase inducing their apoptosis or cell death and enabling potential recovery of normal hematopoiesis. As we continue to treat and follow patients in our Phase II eMERGE trial in lower-risk MDS, data continue to mature and improve. We have an increasingly differentiated profile of Imatelstat compared to other agents, with a high rate of transfusion independence that is similar in both RS-positive and RS-negative patients, a remarkable durability of transfusion independence, even in patients with high baseline transfusion burdens, and substantial rises in hemoglobin levels that suggest potential recovery of normal hematopoiesis in patients treated with Imatelstat. The phase three trial in low risk MDS continues to enroll patients and enrollment is currently expected to be completed by the end of the first quarter of 2021 with top line results expected in the second half of 2022. Imatelstat also represents a highly differentiated therapy designed to address the current unmet need in patients with intermediate to or high risk myelofibrosis unresponsive to JAK inhibitor therapy. In the Telstat treated MF patients who were relapsed or refractory to JAK inhibitors in our phase two Embark trial exhibited a median overall survival that compares very favorably to both historical controls and to a real world data analysis of closely matched patients who discontinued JAK inhibitors and were treated with best available therapy. Based on these analyses and our data and the regulatory clarity we have from our recent interactions with the FDA, we've designed a randomized phase three trial in refractory MF patients with overall survival as a primary endpoint and a control arm of best available therapy that excludes JEC inhibitors. We expect that trial to be open for screening and enrollment in the first quarter of 2021. Both the lower risk MDS and refractory MF indications represent very substantial medical need. And if we are successful in bringing Imatelstack to the market for both indications, we believe they represent a combined annual revenue potential of approximately $1.25 billion in the United States and approximately $2.5 billion worldwide. To execute successfully on our plans in these indications, we'll be relying on our very experienced dedicated in-house professional drug developers. This extraordinary group includes individuals who are key team members working with Imatelstat at Janssen, including our Chief Medical Officer, Dr. Alexandra Rizzo, and our Chief Commercial Officer, Anil Kapoor. These individuals have followed Imatelstat to Jira, bringing with them years of experience in clinical science, regulatory affairs, statistics, clinical operations, and commercial strategy. We've also recruited other talented professionals with experience from other very successful companies in those areas. as well as others in drug safety, manufacturing, and quality operations. And finally, due to our successful recent public offering, today we have the money to achieve our development plans in two phase three indications. It was particularly gratifying to see the response of investors to this transaction, especially leading biotechnology specialist investors such as Eco R1, Great Point, NEA, RA Capital, and Sansara. They joined with other investors in making a very significant investment, which we believe provides strong affirmation for both Immatelstat and Geron. Perhaps that's a good segue to Olivia's discussion of the financing and our updated financial guidance. Olivia?