Release Date: August 21, 2024
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Positive Points
- Completed all three cohorts in Phase Ib of the BTBC 16 study, receiving positive recommendations from the Data Safety Monitoring Board.
- Successfully raised NOK138.9 million from warrant exercise, contributing to a total of almost NOK400 million raised since June of last year.
- Established a partnership with Tempus for tumor CT DNA profiling, providing a meaningful contextual benchmark for study data.
- Leading Axl inhibitor in development for non-small cell lung cancer with significant unmet medical need.
- Fast track designation issued by the FDA, facilitating faster progress in clinical studies.
Negative Points
- Phase IIa study is not randomized, lacking a control arm which may affect the robustness of the data.
- High burn rate of NOK40 million per quarter, with current funds only sufficient to last until the second half of 2025.
- Dependence on external partnerships and synthetic control arms, which may introduce variability and uncertainty.
- Significant unmet medical need in STK11 mutated non-small cell lung cancer patients, with no current therapies available.
- Potential need for additional funding or partnerships to conduct larger pivotal studies and achieve long-term financial sustainability.
Q & A Highlights
Q: You mentioned the pivotal study that you are supposed to discuss with FDA. Do you have any idea of the size, the number of patients, and the timing for such a study?
A: It depends on the strength of our data. If we can show significant improvement, a study with around 250 patients in a two-to-one randomization could be expected. Enrollment could take about two years with the right partner.
Q: What is the status on patient recruitment for the Phase IIa?
A: We have included the second dose and initiated the first dose in May this year. We aim to enroll the study by summer next year, with the first data point expected late this year or early 2025.
Q: What are the major milestones remaining on the Phase II, and when do you expect to present these interim data from the Phase IIa?
A: The first interim data is expected late this year or early 2025. The final data set from the IIa study, in comparison to the Tempus data, is a critical milestone.
Q: Why was the dose for the Phase II decided just recently? Are you lagging behind?
A: No, the IIa study includes two doses to address regulatory requirements upfront. This approach avoids expanding the study size in later phases, ensuring a balance between safety and efficacy.
Q: What would make a positive readout in the Phase II part? What magnitude of improvement are you aiming for?
A: Increasing the response time for patients by more than three months, improving PFS from around five months to eight months, and overall survival from around 10 months to 14-15 months would be considered extremely good data.
Q: Why do you plan to burn cash on external data sets and the synthetic control arm when you still need randomized data?
A: This approach provides a comparative and relevant dataset, offering valuable insights into the strength of our data. It helps convince the FDA for a Phase IIb pivotal study, at less than half the cost and time.
Q: Can you say anything about the financial terms on the Tempus agreement?
A: I cannot disclose financial terms, but this approach is cost-effective, coming at less than half the cost and time compared to generating the data ourselves.
Q: Any updates on the ADCT601 study, the Phase I trial?
A: We are in ongoing dialogue with ADCT Therapeutics and expect an update later this year.
Q: Any updates on the Sobi UT Health San Antonio study, Taverna study?
A: The study protocol has been approved by the FDA, and we are waiting for patient enrollment, which should happen soon.
Q: What strategic plans are in place to transition BerGenBio towards profitability and ensure long-term financial sustainability?
A: Our strategy focuses on conducting studies in significant unmet medical needs. If we generate attractive data, we can either raise funds to conduct the next study ourselves or partner with a significant player for sales and marketing capabilities.
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
