• Revenue: CHF5 million in 2024, exclusively from the Novartis collaboration.
• Operating Expenses: CHF66 million, within the guidance range of CHF65 million to CHF70 million.
• R&D Expenses: 74% of operating expenses are R&D-related.
• Net Financial Result: Benefited from high interest rates on US dollar-denominated deposits.
• Cash Balance: CHF149 million at the end of 2024, down from CHF187 million the previous year.
• Cash Burn: CHF54 million for the year.
• Capital Raise: CHF20 million added from a financing round in October.
• Guidance for 2025 Operating Expenses: CHF55 million to CHF65 million, with CHF7 million expected to be noncash.

• Warning! GuruFocus has detected 3 Warning Signs with MLLCF.

Release Date: March 07, 2025

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

Positive Points

• Molecular Partners AG (MLLCF) has secured a collaboration with Orano Med, ensuring access to Lead-212, a promising isotope for their radio DARPin programs.
• The company has a strong financial position with a cash balance of CHF149 million, providing a runway into 2027.
• The lead compound, DLL3 targeting 712, has passed all IND-enabling studies and is ready to enter clinical trials.
• The company has expanded its pipeline with new targets, including mesothelin, which shows potential for differentiation in the DARPin platform.
• Molecular Partners AG (MLLCF) successfully completed a financing round, adding CHF20 million to its resources, backed by reputable investors.

Negative Points

• The collaboration with Novartis did not progress as expected, leading to the discontinuation of the partnership due to lack of strategic interest in the targets.
• The T cell engager program, 533, initially showed underwhelming results, requiring adjustments to dosing and administration to improve efficacy.
• The company faces challenges in isotope supply logistics, which are critical for the success of their radio DARPin programs.
• The 621 molecule in HSCT is not being actively moved forward and is up for partnering, indicating a deprioritization of this program.
• The company acknowledges that the mesothelin target has been challenging for others, and its success remains to be proven in clinical settings.

Q & A Highlights

Q: Can you provide more color on where you are in the IND submission process for MP0712 and preparations for study initiation? How should we be thinking about the initial clinical data by year-end? Also, why is mesothelin a good target for radio DARPin? A: We started 2025 with GMP manufacturing, which has progressed well. We anticipate submitting to the FDA in Q2, with the imaging part of the program starting in Q3. Initial therapeutic doses are expected later in the year. If the FDA agrees to our proposal, we should see early clinical data in early 2026. Mesothelin is a promising target due to high expression in ovarian cancer, and we hope the alpha radiation will effectively target these cells.

Q: What learnings did you take from the Novartis programs before they were discontinued? Were there any issues with the DARPin hitting the target? A: The collaboration with Novartis taught us about the profile needed for a good radiotherapeutic, including tumor-to-kidney ratios and half-life considerations. The targets chosen did not progress as expected, and both parties agreed not to continue. The DARPin technology itself was not the issue; rather, the targets did not align with strategic interests.

Q: Regarding the DLL3 in radiotherapy, are there any on-target off-tumor DLL3 expressing organs to be concerned about? A: DLL3 is a clean target with minimal expression outside tumors. The pituitary gland has some expression, but no adverse events have been reported in other programs targeting DLL3. We are confident in the safety profile based on existing data.

Q: How do you think about partnering for the switch DARPin platform? Would it be for individual molecules or platform-wide? A: Partnering could be for individual molecules or platform-wide, depending on the partner's needs. Some partners may seek specific candidates to fill pipeline gaps, while others may be interested in broader platform capabilities. Discussions are ongoing, and we are open to both approaches.

Q: Will the Phase 0 and Phase 1 studies for 712 run in parallel, or is Phase 1 contingent on good imaging data? A: We propose to the FDA that the studies run in parallel, supported by animal data. However, the final decision rests with the FDA. Ideally, they will be closely staggered to benefit patients who prefer treatment over imaging alone.

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