Release Date: August 27, 2024
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Positive Points
- Molecular Partners AG (MLLCF, Financial) reported strong financial health with CHF 159 million in cash, extending their runway into 2027.
- Significant progress in multiple programs, including MP0533, MP0621, and MP0317, with promising early results.
- Strategic collaboration with Orano Med on Radio-DARPins, showing potential for innovative cancer treatments.
- Promotion of Philippe Legenne to Chief Medical Officer, highlighting strong leadership and successful trial execution.
- Positive feedback from key opinion leaders (KOLs) and investigators, indicating strong support for ongoing clinical trials.
Negative Points
- MP0533 faced challenges with optimal exposure and concentration, requiring protocol amendments for higher and more frequent dosing.
- Observed toxicities in MP0533, including Grade 3 febrile neutropenia and lymphopenia, raising concerns about the therapeutic window.
- Uncertainty around the future of MP0533 if higher dosing does not yield improved results, potentially leading to discontinuation.
- The Radio-DARPins program with Novartis is progressing slower compared to the collaboration with Orano Med, due to different strategic focuses.
- Switch DARPin program is still in preclinical stages, with uncertainties around its clinical positioning and strategic importance.
Q & A Highlights
Q: How are you thinking about escalating the higher doses for MP0533 and balancing efficacy with toxicity?
A: We are intensifying the dose by administering higher doses more frequently, especially in the first week, to improve exposure. So far, we have seen manageable safety profiles with mainly IRR and CRS, and no significant target-dependent toxicities. We aim to achieve better disease control by increasing the dose intensity early on and then transitioning to weekly dosing once the disease is under control. (Patrick Amstutz, CEO; Philippe Legenne, Chief Medical Officer)
Q: What is the expected timeline for the Radio DARPin clinical trial, and what will the trial design look like?
A: The clinical trial for MP0712 is expected to start in the second half of 2025. The initial phase will focus on imaging and biodistribution to assess where the drug accumulates, followed by dose escalation for therapeutic purposes. The trial will primarily include patients with small cell lung cancer, with potential expansion to neuroendocrine tumors based on initial results. (Patrick Amstutz, CEO; Philippe Legenne, Chief Medical Officer)
Q: Can you provide an update on the Novartis partnership and how it compares to the progress with Orano Med?
A: The collaboration with Novartis involves two specific targets and is part of their broader radioligand program. Progress is ongoing, but the pace is slower compared to our work with Orano Med, which has been more agile and aligned with our approach. The differences in isotopes used (lead vs. actinium) also influence the development timelines and strategies. (Patrick Amstutz, CEO; Daniel Steiner, SVP Research & Technology)
Q: What are the key factors you are monitoring to balance toxicity and efficacy for MP0533 as you increase the dose?
A: We are closely monitoring for cytopenia and neutropenia, which could indicate on-target toxicity. So far, the observed toxicities, such as CRS, have been manageable and primarily related to T-cell activation. We aim to achieve a higher and more sustained exposure to improve efficacy while keeping an eye on these potential toxicities. (Philippe Legenne, Chief Medical Officer)
Q: What would be the most likely reason for discontinuing the MP0533 program if it doesn't meet expectations?
A: If MP0533 does not achieve a sufficient response rate or duration of response, we may discontinue the program. This decision would be based on clinical data and the availability of other promising opportunities within our pipeline. We aim to set clear benchmarks for efficacy and safety to guide this decision. (Patrick Amstutz, CEO)
Q: Can you provide more details on the Switch DARPin program and its potential clinical applications?
A: The Switch DARPin program involves an immune cell engager that targets Ckit and CD40. We are currently conducting non-primate trials to gather data that will inform the clinical trial design. Potential applications include AML and stem cell conditioning, with the latter being a high medical need area. The data will help us decide the best clinical path forward. (Patrick Amstutz, CEO)
Q: How do you plan to maintain drug exposure for MP0533 when transitioning from dose intensification to weekly dosing?
A: We aim to reduce the tumor burden quickly with dose intensification, which should allow for less frequent dosing once the disease is under control. This approach is designed to avoid continuous exposure and potential T-cell exhaustion while maintaining efficacy. (Philippe Legenne, Chief Medical Officer)
Q: What are the key milestones and financial outlook for Molecular Partners in the coming year?
A: Key milestones include higher and more frequent dosing for MP0533, advancing the Switch DARPin program, and initiating clinical trials for MP0712. Financially, we are in a strong position with CHF159 million in cash, providing a runway into 2027. We have updated our operating expense guidance to CHF65-75 million for the year. (Robert Hendriks, SVP Finance)
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
