• Quarterly Revenue: Approximately $40 million, slightly lower due to less sourcing of standard of care.
• Cash Position: $175 million Norwegian Kroner, projected to fund operations until the third quarter of 2025.

Release Date: November 13, 2024

For the complete transcript of the earnings call, please refer to the full earnings call transcript.

Positive Points

• BerGenBio ASA (FRA:7BG0) has identified a significant unmet medical need in STK 11 mutated patients, presenting a substantial market opportunity.
• The company has received a fast-track designation from the FDA for its treatment, indicating potential for expedited development and review.
• BerGenBio ASA (FRA:7BG0) has a strong safety database, having studied its molecule in over 600 patients, which supports its ongoing clinical trials.
• The company is leading efforts in addressing STK 11 mutated populations with its AXL inhibitor, positioning itself as a pioneer in this niche.
• Financially, BerGenBio ASA (FRA:7BG0) is stable, with sufficient cash reserves projected to fund operations into the third quarter of 2025.

Negative Points

• The company has faced administrative delays in some study sites, which could impact patient recruitment timelines.
• BerGenBio ASA (FRA:7BG0) has discontinued its Sylvest program due to the lack of attractive partnership opportunities.
• The ADC 601 program faced setbacks due to a narrow therapeutic window, leading to its discontinuation by ADC Therapeutics.
• There is limited news flow between quarterly updates, which may cause concern among investors seeking more frequent updates.
• The CEO, Martin Olin, is leaving the company, which could lead to uncertainties during the transition period until a new CEO is appointed.

Q & A Highlights

• Warning! GuruFocus has detected 2 Warning Signs with FRA:7BG0.

Q: When do you expect to present the interim data from the BTBC 16 study? A: The interim data is expected to be presented in the early part of 2025. However, an exact date cannot be provided as the data readout is not under our control.

Q: When will the complete data set from the phase two part be available? A: The final readout could be as late as 2026, as the study protocol commits to following patients for two years. The exact timing will depend on the data.

Q: Why was the work on Sylvester discontinued? A: In 2022, we decided to focus our strategy and discontinued internal efforts on Sylvester. Despite outreach efforts, no attractive partnership was found, leading to the program's closure.

Q: What was the reason for adding David Coldman to the board? A: David Coldman brings extensive experience in business development and licensing from pharmaceutical and biotech companies, which is a valuable addition to the board's competencies.

Q: Why is CEO Martin Olin leaving, and will his departure impact BGB activities? A: Martin Olin is leaving for a personal opportunity unrelated to Bergenbio. His departure will not impact BGB activities, as he will remain until a new CEO is appointed, ensuring a smooth transition.

Q: Why is there limited news flow between quarterly updates? A: The limited news flow is due to the nature of clinical studies, which require sufficient patient exposure to the drug before analysis. No news is not necessarily bad news, as it is data-driven.

Q: Are there plans to change the communication strategy? A: There are no plans to change the communication strategy. The current approach aims to be transparent and direct, providing relevant information to shareholders at appropriate times.

For the complete transcript of the earnings call, please refer to the full earnings call transcript.