Geron Corporation

Good afternoon, ladies and gentlemen. My name is Abby, and I will be your conference operator today. At this time, I would like to welcome everyone to the Jerron Corporation first quarter 2022 conference call. Today's conference is being recorded, and 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 the star key, followed by the number one on your telephone keypad. If you would like to withdraw your question, press star one once again. Thank you. And at this time, I would like to turn the conference over to Erin Feingold, Vice President of Investor Relations and Corporate Communications. You may begin.

Good afternoon, everyone. Welcome to the Geron Corporation First Quarter 2022 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 of Finance and Chief Financial Officer and Treasurer. Dr. Alexander Rizzo, 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 Immatel-STAT, anticipated clinical and commercial events and related timelines, the sufficiency of Geron's financial resources, and other statements that are not historical facts. Actual events or results could differ materially. Therefore, I refer you to the discussion under the heading Risk Factors in Jaron's quarterly report on Form 10-Q for the quarter-ended March 31, 2022, which identifies important factors that could cause actual results to differ materially from those contained in the forward-looking statements. Jaron undertakes no duty or obligation to update our forward-looking statements. And now, I will turn the call over to CEO Dr. Scarlett. Chip?

Thanks, Aaron. Good afternoon, everyone. Thanks for joining us today. This quarter, we continue to build on the momentum from our clinical execution throughout 2021. We believe we're well positioned to realize the transformative potential within the Telstat inhibitor-launched malignancies. Most importantly, we're only eight months away from the top-line results from our eMERGE Phase III trials in low-risk MDS, which we expect in early January 2023. This is the first of two significant data readouts for imitelstat over the next two years. I'll speak about the other one in a few minutes. In their lower-risk MDS patients, key opinion leaders and community hematologists underscore the significant unmet need for durable transfusion independence. If the durability and safety data from our Phase II study are confirmed in the Phase III trial, imitelstat could represent a significant treatment advance for these patients. because we believe no other product has provided the rates of 24-week and one-year transfusion independence seen in the eMERGE Phase II study. In addition, unlike currently approved therapies, Imatelstat offers the potential to treat both RS-positive and RS-negative patients, as well as to provide potential disease modification. We expect these characteristics to strongly differentiate Imatelstat in the lower-risk MDS treatment landscape and to create a broad commercial opportunity. We're also making steady progress in opening clinical sites for our IMPACT-MF phase three refractory MF trial, which is expected to enable an interim analysis in 2024. This interim analysis will be the second significant data readout for Intel step. With the recent start of our improved MF phase one combination study, our pipeline expansion program is picking up momentum. That pipeline expansion program, including the IMPROVE-MF Phase 1 study in frontline MS and the two investigator-led studies in AML, enables us to study the potential to limit Telstat as a combination therapy and an additional indication. A key objective for this quarter was to raise additional capital to provide financial flexibility as well as to broaden our investor base. We're pleased that we achieved both goals with the closing of a $70 million net public offering on April the 1st. This public offering garnered keen interest from biotech specialist investors, including Vivo Capital, RA Capital, TCGX, EcoR1, New Enterprise Associates, and HealthCore Management. We believe that Geron represents a strong investment opportunity for these and other investors due to our compelling Phase II data the nearness of our lower risk MDS Phase III readout, the commercial opportunities of our potential indications, and the strength of our internal capabilities and management team. Our current financial resources, plus the net proceeds from this financing, plus the additional funding in 2023 from potential warrant exercises, are expected to provide the financial resources necessary to support our planned key milestones through the end of 2023. Assuming positive top-line results from the MERGE Phase III trial, these key milestones include submission of a U.S. new drug application, or MDA, in the first half of 2023, submission of a European Marketing Authorization application, or MAA, in the second half of 2023, and preparatory activities for a potential 2024 U.S. commercial launch of Imatelstat and lower-risk MDS. We also expect these current and projected financial resources will provide us the cash runway to consider various strategies to maximize the value of the Mittelstat for patients and shareholders. These could include partnering, additional debt, structured instruments such as royalty monetization, or other strategic options. Before I turn the call over to my colleagues, I'd like to highlight my very strong confidence in and appreciation for my remarkable Geron colleagues. It's the collective excellence in execution across the company as we approach significant milestones that will unlock value for patients and for shareholders. With that, I'll turn the call over to our Chief Medical Officer, Alexandra Rizzo, for a clinical update. Alex?