MP0533 data presented at European Hematology Association (EHA) highlights improved response rates and antitumor activity in low disease burden patients; additional data under amended dosing scheme expected in Q4 2025IND filing on first radio-DARPin program MP0712 and initiation of Phase 1 trial expected by end 2025; update on early imaging work planned in Q4 2025; expanded strategic radiotherapy partnership with Orano MedAppointed Martin Steegmaier, Ph.D. as CSO and member of Executive CommitteeCash and cas ...

Radio-DARPin Therapy & MP0712 - Molecular Partners is focused on oncology with differentiated assets like MP0533 and MP0712, addressing unmet medical needs[8] - The company has CHF ~149 million, ensuring funding into 2027[8, 110] - MP0712, a 212Pb-DLL3 targeted radiotherapeutic, addresses the critical unmet need in SCLC, where >85% of patients express DLL3[36, 39] - Preclinical data shows MP0712 induces complete tumor regression in ~70% of mice at 4x 10µCi and ~20% of mice at 8x 5µCi in the NCI-H82 tumor model at day 63[45] - MP0712 clinical development strategy includes Phase 0 imaging studies and Phase 1 dose escalation studies starting in H2 2025, with initial clinical data expected by YE[54] Next-Gen Immune Cell Engagers & MP0533 - MP0533 is a tetra-specific T-cell engager designed to kill AML cells by targeting CD33, CD123, and CD70[69, 77] - Preliminary data from the MP0533 Phase 1/2a study shows 4 responders reported in DR 1-7 with manageable safety[80] - An improved MP0533 exposure was achieved at DR 8 with a steeper and denser step-up dosing regimen[82, 86] Switch-DARPin Platform - The Switch-DARPin platform aims to overcome limitations of current T cell engagers by enabling targeted and conditional activation of immune cells[94, 101] - Preclinical data shows the EpCAM-MSLN-CD2/CD3 Switch induces tumor regression more efficiently than a MSLN-CD3 engager (Tritac)[107]

Company Overview - Molecular Partners is a clinical-stage biotech company pioneering DARPin therapeutics for patients, with operations in Switzerland and the US[8] - The company is well financed into 2027 with approximately CHF 149 million[8] (Note: The outlook section mentions CHF ~131 million[95], so there might be a slight discrepancy) - Molecular Partners has proprietary DARPin platforms, including Radio-DARPins and Switch / T cell engagers[8] Pipeline Highlights - MP0712 (Radio-DARPin Therapy targeting DLL3) is in co-development for SCLC & NECs[9] - The co-development agreement with Orano Med includes up to 10 RDT programs, including MP0712[9] - MP0533 (Next-Gen Immune Cell Engager) is being developed for r/r AML and AML/MDS[9] MP0712 (Radio-DARPin Therapy) - MP0712 is the first 212Pb-DLL3 targeted radiotherapeutic for SCLC, where >85% of SCLC patients express DLL3[25] - Preclinical studies show MP0712 induces complete and durable tumor regression in the NCI-H82 tumor model at 10µCi injected every week[28] - Phase 1 study is expected to start in H2 2025, with initial safety and efficacy data in 2026[33] MP0533 (Tetra-specific T-cell Engager for AML) - MP0533 is designed to induce T cell-mediated killing preferentially when 2 or 3 AML-associated antigens are co-expressed[66] - Preliminary data from the Phase 1/2a study shows encouraging blast reduction, particularly in patients with lower disease burden at baseline[75] - Improved MP0533 exposure was observed at DR 8 with a steeper and denser step-up dosing regimen[78]

Core Viewpoint - Molecular Partners AG announced positive updated data from a Phase 1/2a trial of its tetraspecific T-cell engager MP0533 for relapsed/refractory acute myeloid leukemia (AML) at the EHA Congress in Milan [1][2] Group 1: Trial Results - In cohort 8, 3 out of 8 evaluable patients (over 30%) achieved a clinical response after the first cycle, including 1 complete response and 2 complete responses with partial hematologic recovery [3] - Patients in cohort 8 maintained exposure to MP0533 for over 4 days within the predicted therapeutic range, with 5 out of 8 patients showing more than 50% blast reduction [4] - The safety profile of MP0533 was deemed acceptable after the adjustment of the target dose in cohort 8 [9] Group 2: Dosing Regimen - Cohort 8 implemented a higher starting dose and an additional day of dosing, reaching the target dose by day 12 instead of day 15, which contributed to improved clinical responses [3][6] - The amended protocol for cohort 9 includes further acceleration of the step-up dosing, increased frequency of dosing, and the introduction of anti-CD20 premedication to enhance therapeutic exposure and response duration [7][9] - Initial data from cohort 9, which is currently dosing patients, is expected in the second half of 2025 [8] Group 3: Company Overview - Molecular Partners AG is a clinical-stage biotech company focused on developing DARPin therapeutics, with oncology as its main area of focus [10] - The company was founded in 2004 and operates in both Zurich, Switzerland, and Concord, Massachusetts, USA [10]

Core Insights - Molecular Partners AG is undergoing a strategic review to enhance operational efficiency and focus on advancing its clinical assets, resulting in a workforce reduction of up to 40 positions, approximately 24% of total staff [1][2][4] Group 1: Strategic Review and Workforce Reduction - The company has initiated a strategic review aimed at increasing efficiency and sharpening focus on clinical assets, leading to a potential reduction of up to 40 positions [1][4] - The decision to reduce workforce is part of a plan to extend the company's cash runway into 2028, beyond the previous guidance of 2027 [4][7] - A consultation process with employees has begun in accordance with Swiss employment law, and support will be provided to affected employees, including severance packages and job-seeking assistance [3][4] Group 2: Clinical Development Focus - The company is prioritizing the development of clinical assets MP0533 and MP0712, which are expected to provide significant value for patients and shareholders [2][4] - Clinical data from both MP0533 and MP0712 is anticipated in the second half of 2025, maintaining previously announced timelines [4][7] - The strategic review identified redundancies primarily in research and associated functions, allowing for a more focused approach to clinical development [4] Group 3: Financial Outlook - The workforce reduction is expected to lead to cost savings that will become fully effective by early 2026 [3][4] - The company plans to report its half-year financials on August 25, 2025, which will provide further insights into its financial health and operational adjustments [4]

Core Insights - Molecular Partners AG is advancing its clinical programs and expects to achieve key milestones in 2025, including the IND filing and initial clinical data for its lead program MP0712 [2][5][8] - The company has a strong financial position with cash reserves of CHF 131 million as of March 31, 2025, which is projected to fund operations well into 2027 [19] Research & Development Highlights - The strategic partnership with Orano Med has been expanded to co-develop up to ten Pb-labeled radiotherapy programs, including MP0712 targeting DLL3 for small cell lung cancer [3][8] - Preclinical data for MP0712 presented at the AACR 2025 showed high tumor uptake and a favorable toxicity profile, supporting its efficacy in mouse models [4][9] - The IND application for MP0712 is planned for mid-2025, with a Phase 1 dose-escalation study set to begin in the second half of 2025 [5][8] - The second RDT program targeting MSLN is also in development, with promising preclinical data indicating effective binding despite high shedding of MSLN [7][9] Clinical Programs - MP0533, a multispecific T cell engager, is in a Phase 1/2a trial for acute myeloid leukemia, with recent data showing increased response rates in cohort 8 [10][11] - The study protocol for MP0533 has been amended to enhance exposure and response rates, with additional data expected in 2025 [12] - The Switch-DARPin platform aims to improve T cell engagers' safety and potency, with preclinical proof-of-concept data presented at AACR 2025 [13] Financial and Business Outlook - The company anticipates total operating expenses of CHF 55-65 million for 2025, with a portion allocated to non-cash effective costs [18] - The current cash position is expected to support operational needs and capital expenditures through 2027 [19] Corporate Governance Highlights - All motions proposed by the Board of Directors at the Annual General Meeting in April 2025 were approved by shareholders [17]