Geron Corporation

Ladies and gentlemen, thank you for standing by and welcome to the JRON Second Quarter 2020 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 would like to withdraw your question, press the pound key. If you require further assistance, please press star 0. I would now like to hand the conference over to your speaker today, Suzanne Massari, Head of Investor Relations. Thank you. You may begin.

Thank you, Dorothy, and good afternoon, everyone. Thank you for joining us for today's conference call. I am joined today by Dr. John Scarlett, Charon's Chairman and Chief Executive Officer, Olivia Bloom, the company's Chief Financial Officer, and Alexander Rizzo, our Chief Medical Officer. After the market closed today, we announced our second quarter 2020 financial results and recent events via press release. It is available on our website under www.geron.com slash investors. In addition, a live webcast of this 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 Jaron's plans, expectations, timelines, beliefs, statements of potentiality, and projections. These include, without limitation, those regarding the timelines for completion of enrollment of the ongoing Phase III eMERGE and planned refractory MF clinical trials, the top line results from the ongoing Phase III eMERGE trial, and the results from the interim and final analyses from the planned Phase III refractory MF trial. that Imatelstat has potential disease-modifying activity, that Jaron's existing financial resources will be sufficient to fund operations into the second half of 2022, 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 unable to overcome all the clinical, safety, efficacy, technical, scientific, operational, manufacturing, and regulatory challenges to enable expected timelines for eMERGE and the planned refractory MF clinical trial. That regulatory authorities may not permit the further development of Emetelsta on a timely basis or at all. that the COVID-19 pandemic may significantly impact the timeline for both the enrollment and the results of the clinical trial and or drug supply, as well as expectations of operating expenses, and that there may be unexpected operating expenses or events or changes in Jerron's plans that cause either the $70 to $75 million 2020 financial guidance to be revised or the existing financial resources to be insufficient to fund operations into the second half of 2022. 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 Endurance Quarterly Report on Form 10-Q for the quarter ended June 30th, 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. On today's call, Dr. Scarlett plans to make a few introductory comments, after which Ms. Bloom will cover the recent financing, second quarter financial results, and 2020 guidance. Dr. Rizzo will provide an update regarding the effects of the COVID-19 pandemic on the enrollment in our phase three trial in lower risk MDS and discuss key takeaways from the KOL event we hosted last month and cover other recently announced clinical development activities in MDS and MS. Dr. Scarlett will then finish the call with an EU regulatory update and closing remarks. I will now turn the call over to Dr. Scarlett. Jaron's Chairman and CEO. Chip?

Thanks, Suzanne. I'd like to welcome everyone to our second quarter 2020 conference call. Before we begin, I'd like to make a few comments on the COVID-19 pandemic and how we're managing it. In compliance with state and local rules and for the health and safety of our employees, we're restricting access to our offices. Our employees are continuing to work from home and we are limiting business travel to essential business needs only. Despite these challenges, employee productivity and efficiency continues to be very high. Later in the call, Alexandra will comment on the effect of COVID on our clinical activities. So during the second quarter, we achieved several significant milestones that have helped to establish a very positive trajectory for the company. First, after a successful meeting with the FDA, we announced plans to move forward with the phase three clinical trial in refractory MF using a primary endpoint of overall survival. The OS data from Embark suggests Imatelstat treatment could potentially double the remaining life expectancy for patients who become refractory to JAK inhibitors, which today are the only approved therapies for intermediate to and high-risk MF patients. Second, maturing data from the EMERGE Phase 2 trial in lower-risk MPS presented at EHA highlighted extraordinary durability of transfusion independence, including our first time reporting a one-year transfusion independence for a significant number of patients. Also at EHA, we reported new analyses from the Embark Phase 2 clinical trial in myelofibrosis that correlated the median overall survival observed with other clinical endpoints from the trial, such as improvement in fibrosis. Overall, the EHA data and analyses continue to support the potential disease-modifying activity of Imatel-STAT treatment, as evidenced by clinically meaningful, durable transfusion independence and lower-risk MDS, and improvement in overall survival in relapsed refractory MF. A third major milestone was achieved when we completed our recent public offering, which netted approximately $140 million, giving us the financial resources to execute our current development plans and potentially reach two significant value inflection points that are expected in the second half of 2022. Those are achieving top line results from the eMERGE phase three in MTS, and completion of enrollment for the planned phase three in refractory MS. This financing also brought on board a number of very well-respected biotech specialist investors, including Eco R1 Capital, Great Point Partners, NEA, RA Capital Management and Samsara Bio Capital. We believe their investment shows a strong affirmation of both Imatelstat and Jira. So I'd like to hand the call over to Olivia to discuss what the financing needs for our cash position as well as the second quarter financial results. Olivia.