Release Date: August 21, 2024
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Positive Points
- Nykode Therapeutics AS (STU:5VB, Financial) announced a strategic repositioning of its VB10.16 development plan, focusing on locally advanced cervical cancer and recurrent/metastatic head and neck cancer, which have significant commercial potential and unmet medical needs.
- Positive feedback from key opinion leaders and potential future partners regarding the new focus areas.
- Agreement with MSD to supply KEYTRUDA for the C-05 trial, which will be the first trial into locally advanced cervical cancer treatment.
- Exciting advancements in the mRNA oncology vaccine platform, showing superior immunogenicity and tumor control compared to antigen alone vaccines.
- Strong financial position with a cash reserve of $136.5 million at the end of the quarter, providing a solid foundation for future developments.
Negative Points
- Discontinuation of the C-04 trial due to changes in the dynamics related to the standard of care, impacting the timing and feasibility of the trial.
- Decision to discontinue further activities on the NYK011 preclinical program to reallocate resources within the oncology segment.
- Concerns about the impact of Genentech's reorganization on the partnership, although reassurances have been given that the collaboration remains unaffected.
- Potential delays in the recruitment numbers for trials, as seen with the C-04 trial, which could affect future timelines.
- Uncertainty regarding the exact timeline for the next key clinical readout for VB10.16, especially with the discontinuation of the C-04 trial.
Q & A Highlights
Q: In light of the discontinuation of the C-04 trial, has your partnership strategy for the VB10.16 asset changed in any way? More specifically, is the company more willing to end commercial partnership earlier than before? Is it likely that a partnership can materialize before the C-05 trial initiation?
A: (Michael Engsig, CEO) We do consider partnership a very important strategic element of our VB10.16 program and are definitely exploring every opportunity of getting a partner on board. We are looking for a strategic partner for VB10.16, and it is not unlikely that a partnership could materialize before the C-05 trial initiation.
Q: Following the reorganization at Genentech, have you received any reassurance or confirmation that the partnership is unaffected and still prioritized?
A: (Michael Engsig, CEO) We received upfront notice that Ira Mellman was leaving Genentech and that this was part of a reorganization. We have been informed that the reorganization does not reflect a strategic change from Genentech regarding autoimmune therapy. They remain committed to the area and to our partnership, and it is business as usual.
Q: Could you please comment on the status and progress of the Regeneron partnership?
A: (Klaus Edvardsen, Chief Development Officer) From Nykode's perspective, all deliverables agreed in the contract and partnership discussions with Regeneron have been delivered fully and on time. We have every indication that Regeneron is moving the programs forward as planned.
Q: Would you consider downsizing the organization to preserve cash and extend runway?
A: (Michael Engsig, CEO) We are still assessing the consequences of the decision to discontinue C-04. We will communicate any decisions to the organization first and are not in a position to comment further at this time.
Q: Given the C-04 interim readout mid-2025 had been flagged as a potential trigger for partnership discussions, what could be the next key clinical readout for VB10.16?
A: (Klaus Edvardsen, Chief Development Officer) The next clinical readout will be near the end of this year or early next year when we read out dose finding and final dose recommendation in the head and neck cancer trial C-03.
Q: Could the C-05 trial design include a potential interim look to derisk the trial as was planned for the C-04?
A: (Klaus Edvardsen, Chief Development Officer) The C-05 trial will have an interim analysis, but I cannot comment on the details at this meeting. We are in the final stages of settling the design and will guide on that as soon as we communicate the final design together with Merck.
Q: What is the status of the VB10.NEO patent in Europe?
A: (Agnete Fredriksen, Chief Scientific Officer) We have filed in Europe and are going through the office actions. We will inform you once it is granted.
Q: Has the experience in cervical cancer changed development plans for head and neck cancer? For example, whether to also prioritize locally advanced over recurrent metastatic?
A: (Michael Engsig, CEO) The change in strategy for cervical cancer is driven by feasibility aspects and does not affect our strategy for head and neck cancer. We remain committed to advancing VB10.16 in both recurrent, metastatic, and locally advanced settings.
Q: Can you provide some insight into how easy it is to recruit 1L R/M HNSCC patients relative to 2L R/M cervical patients? Do you expect this to change given the number of agents that are expected to enter larger Phase 3 studies within the near term?
A: (Michael Engsig, CEO) There is competition for patients in any trial concept, but the situation in head and neck cancer is different from cervical cancer. We are well-positioned to compete for patients and recruitment in the settings where we have strategically placed VB10.16.
Q: Could you elaborate on a potential timeline to market for the locally advanced cervical cancer setting? Also, how do you see the commercial opportunity patient population in locally advanced cervical cancer compared to the C-04 setting?
A: (Michael Engsig, CEO) The locally advanced cervical cancer setting represents a larger patient population and a bigger commercial opportunity. We are finalizing the design of the trial and will provide guidance on the timeline once it is announced.
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
