Geron Corporation (NASDAQ:GERN) Q4 2023 Earnings Call Transcript February 28, 2024 8:00 AM ET

Company Participants

Aron Feingold - VP of IR and Corporate Communications

John Scarlett - Chairman and CEO

Faye Feller - EVP and CMO

Anil Kapur - EVP of Corporate Strategy and CCO

Michelle Robertson - EVP and CFO

Conference Call Participants

Corinne Johnson - Goldman Sachs

Kalpit Patel - B. Riley

Stephen Willey - Stifel

Ethan Markowski - Needham & Company

Joel Beatty - Baird

Operator

Good morning. My name is Rob and I will be your conference operator today. At this time, I would like to welcome everyone to the Geron Corporation's Fourth Quarter and Full Year 2023 Conference Call. 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] Aron Feingold, Vice President of Investor Relations and Corporate Communications, you may begin your conference.

Aron Feingold

Good morning, everyone. Welcome to the Geron Corporation fourth quarter and full year 2023 earnings conference call. I am Aron Feingold, Geron's Vice President of Investor Relations and Corporate Communication. 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 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 Geron’s most recent periodic report filed with the FDC, which identifies important factors that could cause actual results to differ materially from those contained in the forward-looking statement. Geron undertakes no duty or obligation to update our forward-looking statement.

With that, I'll turn the call over to Chip. Chip?

John Scarlett

Thanks, Aron. Good morning, everyone. Thanks for joining us today. Geron's progress and execution throughout 2023 has paved the way for a potentially transformational 2024 as we plan for the transition to becoming a commercial company. FDA has signed a producer date of June 16, 2024 for imetelstat for the treatment of transfusion-dependent anemia in patients with lower-risk MDS, and has also provided notice that it's scheduled in ODAC as part of the imetelstat NDA review to be held on March 14th, 2024. In addition, a review of our MAA for the same indication is expected to be completed in early 2025. We're focused on and prepared for these critical next steps in the regulatory review process, which we hope will result in approval of what we believe is a highly differentiated and important treatment option for patients with transfusion-dependent lower-risk MDS.