Geron Corporation (NASDAQ:GERN) Q3 2023 Earnings Call Transcript November 2, 2023
Geron Corporation beats earnings expectations. Reported EPS is $-0.08, expectations were $-0.1.
Operator: Good morning. My name is Audrey, and I will be your conference operator today. At this time, I would like to welcome everyone to the Geron Corporation Third Quarter 2023 Earnings Conference Call. Today’s conference is being recorded. All lines have been placed on mute to prevent any background noise. After the speakers remarks’ there will be a question-and-answer session. [Operator Instructions]. At this time, I would like to turn the conference over to Aron Feingold, VP of Investor Relations and Corporate Communications. Please go ahead.
Aron Feingold: Good morning, everyone. Welcome to the Geron Corporation third quarter 2023 earnings conference call. I’m Aron Feingold, Geron’s Vice President of Investor Relations and Corporate Communications. I’m joined today by several members of Geron’s management team. Dr. John Scarlett, Chairman and Chief Executive Officer; Michelle Robertson, Executive Vice President and Chief Financial Officer; Dr. Faye Feller, Executive Vice President and Chief Medical Officer; Anil Kapur, Executive Vice President of Corporate Strategy and Chief Commercial Officer; and Dr Andrew Grethlein, Executive Vice President and Chief Operating 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 imetelstat, anticipated clinical and commercial events and related time lines, the sufficiency of Geron’s financial resources and other statements that are not historical facts.
A scientist in a laboratory smiling with a test tube in hand, representing the company’s research in biotechnology.
Actual events or results could differ materially. Therefore, I refer you to the discussion under the heading Risk Factors in Geron’s quarterly report on Form 10-Q for the quarter ended September 30, 2023, which identifies important factors that could cause actual results to differ materially from those contained in the forward-looking statements. Geron undertakes no duty or obligation to update our forward-looking statements. With that, I will turn the call over to Chip. Chip?
John Scarlett: Thanks, Aron. Good morning, everyone. Thanks for joining us today. This quarter, we continue to make important progress and build momentum along our planned path to develop and commercialize imetelstat, our first in class telomerase inhibitor. This path, we believe, represents a great opportunity for both near and longer-term value creation. 2023 has been a signal year for us, the imetelstat NDA for the treatment of transfusion dependent anemia, and patients with lower risk MDS was submitted and subsequently accepted for FDA review in August, the FDA assigned a PDUFA action date of June 16, 2024. This was followed by validation of the MAA for the same indication in September of this year. Now that our MAA is under review, we expect the earliest potential approval could occur in late 2024 with a European launch potentially in 2025.
We’re continuing to evaluate our strategic options, including self-commercialization or partnering, and expect to be able to provide an update later in 2024. If approved, we believe the imetelstat commercial opportunity in this indication is both differentiated and compelling for three reasons. First, imetelstat’s been shown to be highly effective in several key patient subgroups, where today’s available treatments did not satisfactorily address the needs of patients with this disease. These include RS negative patients, patients with high transfusion burdens, and patients with high serum equal levels. These key clinical attributes of imetelstat have been further reinforced by the ASH abstracts published this morning. New analyses using data from the Phase 3 IMerge trial in transfusion dependent lower risk MDS continue to show a significant durability and breadth of transfusion independence across subgroups, including patients whose needs are not being met by current treatments.
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