Release Date: August 06, 2024
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Positive Points
- Ivonescimab received its first regulatory approval in China for advanced non-small cell lung cancer, marking a significant milestone.
- The HARMONi-2 trial showed ivonescimab monotherapy outperformed pembrolizumab in progression-free survival, a first in a Phase 3 trial for non-small cell lung cancer.
- Summit Therapeutics Inc (SMMT, Financial) raised $200 million in unsolicited funding, extending its cash runway and supporting its expansive goals.
- The company has a strategic collaboration with MD Anderson to accelerate ivonescimab's development across multiple solid tumor types.
- Summit Therapeutics Inc (SMMT) expanded its licensed territories to include Latin America, the Middle East, and Africa, broadening its market reach.
Negative Points
- The company faces risks and uncertainties that could cause actual results to differ from forward-looking statements.
- Operating expenses remain high, with GAAP R&D expenses at $30.8 million and G&A expenses increasing to $14 million in Q2 2024.
- The overall survival data for HARMONi-2 is still immature, limiting the ability to fully assess the long-term benefits of ivonescimab.
- There is uncertainty regarding the timeline for interim readouts for the HARMONi-3 trial, which could impact investor confidence.
- The effectiveness of ivonescimab in lower PD-L1 TPS scores remains unclear, posing challenges in targeting specific patient subgroups.
Q & A Highlights
Q: Could you walk through the data disclosure process for HARMONi-2 at the World Lung Conference? Will there be an abstract text before the presentation?
A: Dave Gancarz, Chief Business and Strategy Officer, explained that HARMONi-2 data is considered a late-breaker abstract at the World Lung Conference. The deadline for abstracts was July 31, and notifications are expected between August 7 and August 10. Titles and abstracts are typically released around August 15, but larger presentations may have their abstracts withheld until the conference. The team is waiting for the acceptance notification to know more about the release timeline.
Q: What is your latest view on overall survival (OS) maturity for HARMONi-2? Will it be included in the presentation?
A: Dave Gancarz noted that the overall survival data is still early, as the trial completed enrollment recently. Allen Yang, Chief Medical Officer, added that the data is immature, but the strength of the progression-free survival (PFS) data is promising. They have not made definitive announcements on what will be presented regarding OS.
Q: Without OS data, what constitutes a good PFS result in isolation? Are there additional Phase 3 plans related to HARMONi-2?
A: Allen Yang stated that they will not comment on PFS results until the meeting. Regarding additional Phase 3 programs, announcements may be made at World Lung, with data maturing in lung and other indications. The development plan will prioritize unmet needs.
Q: How does the PFS data from HARMONi-2 influence your confidence in HARMONi-3, especially with the addition of chemotherapy?
A: Allen Yang expressed confidence in HARMONi-3, noting that the strength of HARMONi-2 data has increased their confidence. The addition of chemotherapy may affect tumor reduction but not the biological importance of ivonescimab for the population.
Q: Can you comment on the potential interim readouts for HARMONi-3 over the next several quarters?
A: Allen Yang mentioned that they cannot disclose specifics about interim readouts for HARMONi-3 at this time. However, their partners at Akeso are running a parallel study, which may provide earlier results.
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
