Yahoo Finance Geron Corp (GERN) Q1 2024 Earnings Call Transcript Highlights: Strategic Moves and Financial Health
Cash and Marketable Securities: Approximately $465 million as of March 31, 2024.
Net Proceeds from Public Offering: Approximately $141 million in March 2024.
Total Operating Expenses Q1 2024: $56.4 million.
Research and Development Expenses Q1 2024: $29.4 million.
General and Administrative Expenses Q1 2024: $27.1 million.
Full-Time Employees: 162 as of March 31, 2024, with plans to grow to 250-300 by year-end 2024.
Projected Full Year 2024 Operating Expenses: Between $270 million and $280 million.
Financial Runway: Expected to support operations into the second quarter of 2026.
Release Date: May 02, 2024
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Positive Points
FDA's Oncology Drug Advisory Committee voted favorably on imetelstat's clinical benefit for lower-risk MDS, indicating strong regulatory support.
Imetelstat is positioned to address significant unmet needs in transfusion-dependent lower-risk MDS, especially in high transfusion burden and RS negative patients.
Geron Corp is in the final stages of commercial readiness, with a fully trained sales force ready for deployment upon potential approval.
The company has a strong financial position with approximately $465 million on the balance sheet, supporting the planned U.S. commercial launch.
Positive feedback from the lower-risk MDS community during the public forum, highlighting the need for new treatments and the potential impact of imetelstat.
Negative Points
The timeline for the Phase 3 IMpact MF trial has been extended by half a year, with interim analysis now expected in early 2026 and final analysis in early 2027.
Lower than anticipated enrollment and death rates in the IMpact MF trial, which could affect the study's timeline and outcomes.
Increased operating expenses, with Q1 2024 expenses rising to $56.4 million from $40.1 million in the same period in 2023, reflecting higher costs associated with commercial preparations and increased headcount.
Potential challenges in updating NCCN guidelines post-approval, which are critical for influencing clinical and payer pathways.
Uncertainties around the final FDA approval and labeling discussions, which are crucial for the commercial launch and market acceptance of imetelstat.
Q & A Highlights
Q: Can you comment on the myelofibrosis trial timelines, whether the delay was due to slower enrollment or fewer events than anticipated? A: (Faye Feller - EVP, Chief Medical Officer) Both enrollment and death rates are lower than anticipated, which has pushed the timelines out by about six months. The specific factors driving this are not detailed, but there is continued enthusiasm for the study.
Q: Have you initiated labeling discussions with the FDA for imetelstat in myelodysplastic syndrome? A: (John Scarlett - CEO) Yes, we've received comments from the FDA on our draft label. We are continuing our conversations with the agency as we approach the PDUFA date but will not publicly disclose ongoing regulatory interactions prior to approval.
Q: How quickly could NCCN Guidelines be updated following the potential approval of imetelstat? A: (Anil Kapur - EVP, Corporate Strategy and Chief Commercial Officer) We are prepared to submit to NCCN upon approval, which includes the approved prescribing information and peer-reviewed publication. Typically, NCCN updates guidelines within two to three months for new drugs.
Q: What are the challenges for enrollment in the myelofibrosis trial, and have there been changes to the standard of care that might explain slower event accumulation? A: (Faye Feller - EVP, Chief Medical Officer) The approval of new Jack inhibitors and the lack of Jack inhibitor treatment options in the best available treatment arm have impacted enrollment. Other factors include resourcing issues at sites and staffing.
Q: Regarding the launch preparation for imetelstat, what are the major steps that need to be completed? A: (Anil Kapur - EVP, Corporate Strategy and Chief Commercial Officer) Key steps include completing the onboarding of the commercial team, ensuring full commercial supply, finalizing the distribution network, and preparing materials for stakeholders. The team is focused on ensuring readiness for a potential U.S. launch in June.
Q: Can you provide guidance on how to model the U.S. launch and initial ramp for imetelstat? A: (Anil Kapur - EVP, Corporate Strategy and Chief Commercial Officer) Focus on the unmet needs of the patient population, particularly those who are high transfusion burden, RS negative, or ESA ineligible. Imetelstat's unique mechanism and data coverage, including luspatercept-pretreated patients, position it well for adoption across various patient segments.
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
This article first appeared on GuruFocus.
