Release Date: August 19, 2024
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Positive Points
- Cue Biopharma Inc (CUE, Financial) has developed a breakthrough proprietary therapeutic approach to establish a new standard of care for treating both cancer and autoimmune diseases by restoring immune balance.
- The CUE-101 Phase 1b trial data shows substantial prolongation of survival in patients treated with monotherapy and in combination with Keytruda.
- Significant progress has been made with the lead autoimmune disease program, CUE-401, in collaboration with Ono Pharmaceuticals, targeting multiple autoimmune and inflammatory diseases.
- The company has implemented a cash-efficient business model, reducing capital requirements and emphasizing strategic partnerships to extend its runway to mid-2025.
- The CUE-500 series, particularly CUE-501, shows promise in selectively depleting B cells, potentially addressing multiple B-cell-mediated autoimmune diseases and B-cell malignancies.
Negative Points
- Cue Biopharma Inc (CUE) is delaying the launch of a capital-intensive trial towards registration, which may impact the timeline for bringing new treatments to market.
- The company is heavily reliant on strategic partnerships to access additional resources and capital, which may introduce uncertainties and dependencies.
- Despite promising data, the company faces significant competition in the oncology and autoimmune disease markets, which could impact its market positioning and adoption.
- The financial outlook remains cautious, with a need to carefully manage cash burn and potentially raise additional capital, which could lead to dilution.
- The maturing data from ongoing trials, while promising, still requires further validation and may face scrutiny from potential partners and regulatory bodies.
Q & A Highlights
Q: Can you speak to the trafficking capacity of CUE-501 and the estimate of CMV-seropositivity in the general population?
A: CMV-seropositivity is around 65% to 70%. For SARS-CoV-2, it's virtually 100%. Immuno-STATs have shown the ability to penetrate solid tumor tissue and engage relevant antigen-specific T cells, which should hold true for the CUE-500 series.
Q: How do you think more mature survival statistics for CUE-101 could help attract strategic interest?
A: The survival data is expected to differentiate CUE-101 and position it competitively. Ongoing dialogue with potential partners indicates that the maturing survival data will be crucial in demonstrating the durability of the immune response triggered by CUE-101.
Q: How do you view the results of CUE-101 in the context of the current landscape, especially with new data from competitors like Merus?
A: The 12-month survival rate for CUE-101 is 90%, compared to 59% for pembrolizumab monotherapy in the LEAD-010 trial. In the second-line setting, CUE-101 monotherapy shows a median OS of 20.8 months, significantly higher than Merus's 11.5 months.
Q: Can you provide an update on the neoadjuvant study?
A: The study is progressing well, with preliminary data looking very encouraging. The investigators intend to submit the findings for publication in a high-level journal.
Q: How do you plan to bridge the gap between now and the initial milestone payments expected from the Ono opt-in?
A: Measures have been taken to reduce burn rate and focus on near-term milestones. Partnering discussions for CUE-501 are ongoing, and these partnerships are expected to provide upfront payments and milestone-based funding to extend the runway.
Q: What are the next steps for positioning CUE-501 for partnering?
A: Discussions with potential pharma partners are ongoing. The focus is on demonstrating the differentiated asset's potential and engaging in strategic dialogue to determine the best indications for development.
Q: Is there room to negotiate and potentially accelerate milestones or opt-in potential with Ono based on the data generated so far?
A: The partnership with Ono has been highly productive, and both parties are aligned on the next steps. There is no current need to modify the existing agreement.
Q: What non-clinical data should we expect next for CUE-401 and CUE-501?
A: Ongoing in vivo experiments for CUE-501 and further data generation for CUE-401 in collaboration with Ono will be shared as they emerge, focusing on efficacy and activity in various disease models.
Q: How does the safety profile of the Immuno-STAT platform differentiate from cell therapies targeting CD19 for autoimmune diseases?
A: The Immuno-STAT platform has shown no clinically relevant immunogenicity and favorable tolerability. It selectively engages a small percentage of T cells, avoiding the broad activation seen with pan T-cell engagers, which should offer superior safety and tolerability.
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
