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 Insights - Molecular Partners AG and Orano Med have announced the launch of MP0726, a Radio-DARPin candidate targeting mesothelin (MSLN), with preclinical data to be presented at the 2025 Annual Meeting of the Society of Nuclear Medicine and Molecular Imaging [1][2] Group 1: Product Development - MP0726 demonstrates high affinity and selectivity for the membrane-proximal domain of MSLN, showing a tumor accumulation of up to 34% and a tumor to kidney ratio of up to 4.5 in vivo [2][3] - The candidate is designed to target ovarian cancer, leveraging the unique properties of DARPins to selectively bind to MSLN, which is highly expressed in tumors but lower in healthy tissues [3][8] - MP0726 is the second Radio-DARPin program to enter preclinical development, following MP0712, which targets DLL3 and is set to begin dosing in a Phase 1 study in the US in the second half of 2025 [6] Group 2: Strategic Collaboration - The collaboration between Molecular Partners and Orano Med has shown significant progress, highlighting the effectiveness of their joint R&D efforts in developing differentiated clinical candidates [4][5] - Orano Med's capabilities in R&D and manufacturing, along with a virtually unlimited supply of the starting isotope, position it uniquely to support the development of these new therapies [4] Group 3: Company Background - Molecular Partners AG is a clinical-stage biotech company focused on developing DARPin therapeutics, with oncology as its main area of focus [9] - Orano Med specializes in targeted alpha-particle therapies using lead-212 (Pb), with its most advanced asset, AlphaMedix, having received Breakthrough Designation from the FDA in 2024 [10]

Three of eight evaluable patients with R/R AML responded after cycle 1 in ongoing cohort 8, including 1 patient with ongoing response beyond 6 monthsAcceptable safety profile across all cohorts, including in cohort 8 with steeper step-up dosingData support further dose optimization to maximize therapeutic benefit of MP0533, with dosing in cohort 9 now ongoing ZURICH-SCHLIEREN, Switzerland and CONCORD, Mass., June 11, 2025 (GLOBE NEWSWIRE) -- Ad hoc announcement pursuant to Art. 53 LR Molecular Partners AG ( ...

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]

Summary of Molecular Partners Conference Call Company Overview - **Company**: Molecular Partners - **Focus**: Development of DARPins, small binding proteins for targeted therapies in oncology [4][5] Key Platforms and Pipeline - **DARPins Platforms**: - **Radiotherapy DARPin Platform**: Utilizes small size to deliver radioisotopes effectively [6] - **T Cell Engager Platform**: Capable of creating bispecific to tetraspecific DARPins targeting multiple tumor antigens [6] - **Clinical Candidates**: - **MPO-712 (DLL3)**: Expected to enter Phase 1 trials in the second half of the year, targeting small cell lung cancer [12][15] - **MPO-533**: Involved in an ongoing Phase 1 trial for acute myeloid leukemia (AML) [44] DLL3 and Small Cell Lung Cancer - **Target**: DLL3, a marker for neuroendocrine tumors, particularly expressed in small cell lung cancer [15] - **Clinical Need**: High unmet medical need in small cell lung cancer, which is often chemo-resistant [15][13] - **Phase 1 Trial**: Aiming to start in the second half of the year, with a focus on relapsed refractory patients [16][19] Radioligand Therapy Insights - **Advantages of DARPins**: Selected for targets that are not easily ligandable, providing a solution for over 70% of targets [9][10] - **Imaging and Dosimetry**: Early imaging data expected to inform dosing and therapeutic windows, with results anticipated in H2 [19][20] - **Lead-212**: Chosen for its short half-life and effective energy delivery, partnered with OranoMed for supply [31][34] MPO-533 and AML Trial Adjustments - **Targeting Strategy**: Trispecific and tetraspecific DARPins designed to target multiple antigens on AML cells [46] - **Trial Adjustments**: Shifted to more frequent dosing to improve patient exposure and response rates, achieving a 30% complete response rate in recent evaluations [51][52] Future Developments - **Switched DARPin Platform**: Aiming to develop smart drugs that utilize logic gating to enhance T cell engagement [58][61] - **Investor Interest**: The new platform is generating interest from potential investors and pharmaceutical partners [62] Additional Considerations - **Supply Chain Management**: OranoMed's ability to provide a consistent supply of Lead-212 is crucial for the success of the radioligand therapy [39][41] - **Regulatory Engagement**: Ongoing constructive discussions with regulators to ensure effective clinical trial designs [29][42] This summary encapsulates the key points discussed during the conference call, highlighting Molecular Partners' innovative approaches in oncology and their strategic focus on DARPins and radioligand therapies.

Molecular Partners (MOLN) FY 2025 Conference May 20, 2025 03:30 PM ET Speaker0 Good afternoon, and thanks for tuning into the HCW, BioConnect conference. I'm Robert Burns, the managing director and senior biotech analyst at HC Wainwright. And I'm joined by Seth Lewis, head of IR for MyPlay Partners. Seth, thank you for joining us today. Speaker1 Really appreciate the invite. Glad to be here. Awesome. So for Speaker0 those who might be unfamiliar with the company, its pipeline, as well as the Platts thing? S ...

Core Insights - Molecular Partners AG is a clinical-stage biotech company focused on developing DARPin therapeutics, which are custom-built protein drugs designed to address medical challenges that other drug modalities cannot effectively tackle [4] Group 1: Upcoming Events - The management team of Molecular Partners will participate in two investor conferences: the H.C. Wainwright 3rd Annual BioConnect Investor Conference on May 20, 2025, and the TD Cowen's 6th Annual Oncology Innovation Summit on May 28, 2025 [2][3] - Both events will be webcast and accessible on the Molecular Partners website under the investors tab [3] Group 2: Company Overview - Molecular Partners was founded in 2004 and has its offices in Zurich, Switzerland, and Concord, Massachusetts, USA [4] - The company is primarily focused on oncology and has various programs in different stages of pre-clinical and clinical development [4] - Molecular Partners collaborates with leading pharmaceutical companies to leverage the advantages of DARPins for unique patient solutions [4]

Clinical programs on track, with two major milestones later this year, and cash position, CHF 131 million as of March 31, 2025, expected to provide funding well into 2027IND filing and initial clinical data on first targeted Radio-DARPin therapy program, MP0712, expected in 2025; strategic partnership with Orano Med expanded from four to ten programsData from dosing cohort 8 in Phase 1/2a trial of MP0533 demonstrate increased rates and depth of responses; study protocol amendment now approved, and dosing co ...

Positive IND-enabling data on MP0712 targeting DLL3, the most advanced Radio-DARPin program in co-development with Orano Med, entering clinical development in 2025 First preclinical data of novel targeted Radio-DARPin against mesothelin (MSLN), in co-development with Orano Med Additional preclinical proof-of-concept data on logic-gated CD3 Switch-DARPin T cell engager with CD2 co-stimulation ZURICH-SCHLIEREN, Switzerland and CONCORD, Mass., April 25, 2025 (GLOBE NEWSWIRE) -- Ad hoc announcement pursuant to ...