Geron Corporation (NASDAQ:GERN) Q3 2023 Earnings Call Transcript

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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Q&A Session

Second, there’s a very large market opportunity for imetelstat and lower risk MDS patients with transfusion dependent anemia, which we estimate represents a total addressable market or TAM of approximately $3.5 billion by 2033 in the U.S., and the EU, for as well as the U.K. And third, this is a market that seemed low competitive intensity and relatively little innovation in the last decade. Despite the recently approved luspatercept label expansion, just last month, the National Comprehensive Cancer Network or NCCN, published a revised version of its MDS guidelines, which still point to limited treatment options available to hematologist as they manage their transfusion dependent low risk MDS patients. Moving beyond lower risk MDS, another key component in Geron’s path to value creation is an expected interim analysis in IMerge, which is a Phase 3 study in JAK I relapsed and refractory MF that’s currently anticipated in the first half of 2025.

IMpactMF is the first and only Phase 3 trial with overall survival as a primary endpoint. If the expected interim analysis in 2025, or the final analysis expected in 2026, is positive. These data could be transformational for patients with relapsed refractory MF, which also represents an underserved very substantial market opportunity, with an estimated $3.5 billion TAM by 2033. Together our lead indications represent a potential TAM of $7 billion in 2033. And beyond that, we continue to investigate the potential of imetelstat and other hematologic malignancy indications and combination trials that could build additional value for the company. Given that opportunity, we’ve been preparing at an enterprise level for transitioning to a commercial company for several years.

This has enabled us to efficiently hire and onboard our commercial and medical affairs leadership teams, scale our internal systems and operations, and build the competencies needed to succeed as a commercial company. Anil will speak further to the commercial opportunity later during this call. We also have a strong cash position of approximately $382 million at the end of the quarter, which based on our current plans and expected available resources, we expect will enable us to fund a potential successful launch in transfusion dependent lower risk MDS in the U.S. and fund our planned operations through the end of the third quarter of 2025. Finally, we have outstanding individuals to lead our organization through this transformation from a development stage to a commercial company.

These individuals now include Michelle Robertson, who we recently appointed as CFO following the retirement of our longtime CFO, Olivia Bloom. We’re thrilled to have Michelle on board at this very important moment in our history. Michelle brings with her over 30 years of financial and commercial operations experience, most recently as CFO of Editas Medicine, and before that CFO of Momenta before its acquisition by J&J. She also spent over 13 years in the finance and commercial operations group at Genzyme. Her deep command of financial operations, her experience with managing the financial and organizational needs of a biotech company, preparing to potentially launch its first commercial product and her prior experience with investors, analysts, investment bankers, as well as her hands on experiences with commercial launches in the past will all be extremely valuable to our organization going forward.

With that, I’ll turn the call over to Faye for a regulatory and clinical update.

Faye Feller: Thanks, Chip, and good morning to everyone on the call. As Chip mentioned, we accomplished critical regulatory milestones this quarter, with the acceptance of our regulatory filings in the U.S. and EU for review of imetelstat for the treatment of transfusion dependent anemia in patients with low risk MDS, who have failed to respond or have lost response to or are ineligible for ESAs. The FDA assigned a PDUFA action date of June 16, 2024. The FDA also informed us that they are planning to hold an advisory committee meeting. We have no further details at this time about a potential date or agenda for this meeting. As in best practice in our industry, we are working with a consultancy group who has expertise and advisory committees to complement our deep in-house regulatory experience, and we expect to be highly prepared.

We believe we have an important medicine in imetelstat and we look forward to the opportunity to discuss it with experts. As Chip also mentioned, we are pleased that the ASH abstracts published this morning continue to demonstrate what we believe are the unique and differentiated qualities of the imetelstat in lower risk MDS seen in the IMerge Phase 3 study, including the breadth of effect across MDS subgroups and the unprecedented durability of transfusion independence. I will now provide a brief overview of the abstracts. Please note that we issued a press release this morning at 9 am Eastern Time, which describes the abstracts in more detail and that all abstracts are available on the ASH website. The first abstract was accepted for an oral presentation and characterizes TI responses in the imetelstat and placebo treated patients using various risk classification systems.

This subgroup analysis demonstrated that imetelstat consistently had higher TI response rates than placebo, across different risk subgroups, irrespective of risk classification system. Using the most recent and precise IPSS-M classification system, which takes into account the prognostic effect of molecular mutations, over 13% of IPSS low or intermediate one risk patients enrolled in the IMerge Phase 3 or upstaged have moderate high, high or very high risk MDS. Notably, despite having an MDS that would be classified as higher risk under IPSS-M. These patients benefited from imetelstat treatment compared to placebo. For example, as you can see in the last few rows of the table on the slide, among the M IPSS high, very high group, the eight-week RBCT rate was 40% for imetelstat and zero for placebo.