Geron(US:GERN)2024-05-02 16:32Financial Data and Key Metrics Changes - As of March 31, 2024, the company had approximately $465 million in cash and marketable securities, including net proceeds of approximately $141 million from a public offering [5][80] - Total operating expenses for Q1 2024 were $56.4 million, compared to $40.1 million for the same period in 2023, reflecting increased investment in commercial activities [58] - General and administrative expenses for Q1 2024 were $27.1 million, up from $12.9 million in Q1 2023, primarily due to commercial preparatory activities [31] Business Line Data and Key Metrics Changes - The company is in the final stages of commercial readiness for Imetelstat, with a sales force being brought on in April 2024 [9][12] - The clinical trial for Imetelstat in lower-risk MDS is ongoing, with the Data Monitoring Committee recommending the trial continue based on unblinded data [10][50] Market Data and Key Metrics Changes - Market research indicates that Imetelstat is highly differentiated in the transfusion-dependent low-risk MDS market, with significant dissatisfaction among medical and payer stakeholders regarding current treatment options [13][20] - The company expects meaningful uptake of Imetelstat among ESA ineligible patients, particularly those who are RS negative [19][20] Company Strategy and Development Direction - The company is focused on executing a successful U.S. launch of Imetelstat upon potential FDA approval, with a PDUFA date set for June 16, 2024 [36][60] - The company plans to engage with NCCN to update treatment guidelines for Imetelstat following FDA approval [18][66] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's readiness for the U.S. launch of Imetelstat, highlighting the positive ODAC outcome and the need for new treatment options in the low-risk MDS space [5][60] - The company acknowledges the challenges in enrollment for the myelofibrosis trial, attributing it to factors such as competition from newly approved JAK inhibitors [69][70] Other Important Information - The company has established commercial supply arrangements and finalized its specialty distribution network in preparation for the launch [40] - The company anticipates that existing cash and projected revenues will support operations into the second quarter of 2026 [59] Q&A Session Summary Question: Can you comment on the myelofibrosis trial timeline? - Management noted that both enrollment and death rates are lower than anticipated, impacting timelines by approximately six months [62][63] Question: Have you initiated labeling discussions with the FDA for Imetelstat? - The company confirmed that it has received comments from the FDA on the draft label and is looking forward to continuing discussions as the PDUFA date approaches [65] Question: How quickly could NCCN guidelines be updated following approval? - The company expects to submit the necessary documentation to NCCN upon approval, with updates to guidelines typically occurring within two to three months [66] Question: What challenges are impacting enrollment in the myelofibrosis trial? - Management indicated that the approval of additional JAK inhibitors and resource issues at trial sites have contributed to slower enrollment rates [69][70] Question: What are the major steps remaining for launch preparation? - The company is focused on completing onboarding of the commercial team and ensuring full commercial supply and distribution networks are in place [72][88]