Geron Corporation

Good afternoon. My name is Rob and I will be your conference operator today. At this time, I would like to welcome everyone to the Geron Earnings second quarter 2022 conference call. All lines have been placed on mute to prevent any background noise. And today's conference is being recorded. 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 star one. Thank you. Erin Feingold, Vice President of Investor Relations and Corporate Communications. You may now begin your conference.

Good afternoon, everyone. Welcome to the Geron Corporation second 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. 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 Immatel-Stat, anticipated clinical and commercial events, and related timelines. the sufficiency of Jerron'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 quarterly report on Form 10-Q for the quarter ended June 30, 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 statement. And now, I will turn the call over to CEO Dr. Scarlett. Chip?

Thanks, Erin. Good afternoon, everyone. Thanks for joining us today. This is an exciting time to be at Jaron. We expect the journey ahead will emphasize potential value-accreting milestones that reflect InnoTelStats' unique and highly differentiated qualities that in turn we believe address many of the current unmet needs of patients with both lower risk myelodysplastic syndromes, or MDS, and refractory myelofibrosis, or MF. As such, we're planning for an upcoming catalyst-rich period during which we will be focused intently on the execution that we expect will take us from being a development stage company to a commercial company. I'm personally very excited that we're only five months away from the first of these exciting milestones, which is the disclosure of top line results from our Emerge Phase 3 trial in lower risk MDS that are expected in early January of 2023. In advance of those top line results, we're already actively preparing for two regulatory submissions in the syndication lower risk MDS. The first, expected in the first half of 2023, will be a submission of a U.S. new drug application, NDA, and the second, which will be the submission of a European marketing authorization application, or MAA, which we expect in the second half of 2023. If the lower-risk MDS top-line results are positive and these regulatory activities are successful, we expect U.S. approval and commercial launch of Imatelstat and lower-risk MDS in the first half of 2024. Also in 2024, we anticipate an interim analysis of the ongoing IMPACT-MF phase three study in refractory myelofibrosis. This assumes that enrollment meets our expectations and that a sufficient number of events have occurred to enable such an analysis. A positive readout in this trial, which is comparing Imatelstat to best available therapy, would have major implications. Impact MS is the only MS study being conducted today with a primary endpoint of overall survival. Improvement in overall survival is consistently ranked by hematologists near or at the top of the desired qualities of a new medicine in refractory MS. Returning to lower risk MDS, we believe Imatelstat represents a potentially transformative treatment option as well as a significant commercial opportunity in this indication. Based on the market research conducted by our commercial team, practicing hematologists cite several key attributes of imitelstat that were observed in the eMERGE Phase II study and that address current unmet medical needs in this indication. First, the durability of transfusion independence that was observed in Phase II addressed what these hematologists cited as the most significant current unmet need for the lower risk MDS patients. Second, they cited the expected ability of Imatelstat to treat a broader set of patients, including both RS-positive and RS-negative subsets, as well as a broad range of patients with high and very high transfusion burdens. They believe data such as these would differentiate Imatelstat significantly from other currently available therapies in this indication. For example, Luspatercept is restricted for use in only RS-positive patients, which represents approximately a quarter of the market. Third, these hematologists cited the novel mechanism of action of Imatelstat. This mechanism is also significantly differentiated from the mechanism of other treatments for low-risk MDS and leads to the potential for disease modification. This disease-modifying potential was supported by clinical outcomes in the Phase II study including very meaningful increases in hemoglobin, as well as depletion of malignantly transformed cells after treatment with imetel statin. These key attributes, as well as a manageable safety profile from the Phase 2 study, give us confidence that the outcomes in the Phase 3 trial have the potential to address the unmet needs of the approximately 33,000 patients with lower risk MDS in the US and largest five EU markets who are relapsed and refractory to ESAs. This translates to a significant market opportunity of approximately $1.2 billion in potential peak revenues across these lower risk MDS markets. To capitalize on the potential of this market opportunity, a stage-gated build-out of the US commercial team and plan has begun. which we plan to accelerate if we achieve positive top-line results in early January 2023. For Europe, we're considering our options, including potential partners, as well as self-commercialization, with the goal of bringing Imatelstat to patients in that marketplace as efficiently and effectively as possible. Putting these upcoming milestones together, we believe Geron has the necessary elements for significant value creation over the next several years. These include the lower risk MDS phase three top line data, the build out of the U.S. commercial team and plan, the impact MF phase three data from the interim analysis, and the unique product attributes of Immetelstat that are expected to allow it to successfully address unmet needs. In addition to the corporate attributes I've already discussed, another key element that we expect to lead to an ability to deliver the expected value creation is our strong balance sheet. In late March of this year, we raised approximately $70 million in net proceeds from a public follow-on offer. This past quarter, we secured up to an additional $50 million in potential non-deleted capital through an amendment to expand our existing loan facility with Hercules Capital and Silicon Valley Bank. These additional debt tranches increase our total available debt facility from up to $75 million to up to $125 million. We believe these potential additional debt proceeds when added to our current financial resources and the projected proceeds from exercises of current outstanding warrants in 2023 will be sufficient to fund our projected level of operations until the middle of 2024. This strong balance sheet should also give us flexibility as we consider potential additional strategic funding and partnership opportunities after disclosure of top-line results in the lower-risk MDS Phase III trial in early January of 2023. Finally, I'd like to comment on our deeply talented management team. We continue to build an employee base that is both experienced and knowledgeable in hematologic malignancies, as well as in the commercial path ahead. The recent appointment of Dr. Faye Fowler as our Chief Medical Officer, with Dr. Alexandra Rizzo having transitioned to her new role as Senior Medical and Regulatory Advisor, exemplifies the type of management expertise and capabilities in Jurong today. Faye has been a cornerstone in the history of Immatel-Statt's clinical development, from working on the Phase II Immatel-Statt studies at Janssen starting in 2015, to driving our Phase III trials and designing our pipeline expansion studies at Jurong, beginning in 2019, Faye has been instrumental in the design and management of the entire Immatel-Statt development program in malignancies. I'd like to give Faye the opportunity to briefly introduce herself on this call. Following that, Olivia will provide a financial update, and then I'll make my concluding remarks. Faye?