Molecular Partners (NasdaqGS:MOLN) Update Summary Company Overview - **Company**: Molecular Partners - **Focus**: Development of MP0712, a novel radiotherapy targeting DLL3 for small cell lung cancer and other neuroendocrine tumors Key Industry Insights - **Collaboration**: Partnership with Orano Med to pioneer radiotherapy, signed in January 2024 [4][5] - **Clinical Development**: Initiation of phase one clinical trials for MP0712 expected by the end of 2025, pending regulatory approval [12][20] Core Points and Arguments 1. **Unique Mechanism of Action**: MP0712 utilizes a DARPin engineered to target DLL3, which is prevalent in small cell lung cancer, enhancing therapeutic efficacy [4][28] 2. **Preclinical Data**: Demonstrated strong tumor regression and control in preclinical studies, with effective tumor accumulation and low kidney uptake [6][7][11] 3. **Imaging and Dosimetry**: Use of lead-203 for imaging to inform dosimetry calculations before treatment with lead-212 [12][20] 4. **Patient Case Study**: A 69-year-old patient with small cell neuroendocrine carcinoma showed significant tumor uptake and reclassification from stage three to stage four based on imaging data [13][14][19] 5. **Phase One Study Design**: Multi-center study focusing on dose escalation for small cell lung cancer, with plans to branch into other neuroendocrine cancers [20][22] 6. **Regulatory Pathway**: Potential for accelerated approval due to high unmet medical need in small cell lung cancer [22][64] Additional Important Insights - **Competitive Landscape**: MP0712 aims to differentiate itself from other DLL3-targeted therapies by offering a superior side effect profile and a unique delivery mechanism [32][49] - **Future Pipeline**: Plans to explore additional targets and indications based on the learnings from DLL3, including bispecifics and other low copy number internalizing targets [37][39] - **Supply Chain Confidence**: Assurance in Orano Med's supply chain capabilities to support potential rapid market entry [64] Conclusion - **Strategic Positioning**: Molecular Partners is positioned to become a leader in alpha therapy for small cell lung cancer, with a robust pipeline and promising early clinical data [28][70]

Core Insights - Molecular Partners AG presented new data on MP0712, a Radio-DARPin targeting DLL3, at the Targeted Radiopharmaceuticals Summit Europe, showcasing promising human imaging results and supporting mechanism of action data [1][2][3] Clinical Development - MP0712 is being developed in collaboration with Orano Med for treating small cell lung cancer (SCLC) and other neuroendocrine cancers, with a Phase 1 trial expected to start by the end of 2025 [1][7] - The Phase 1 Investigational New Drug (IND) application has been filed, and ongoing discussions with the FDA are taking place [7][8] Imaging and Efficacy - Initial imaging results indicate targeted delivery of MP0712 into tumors with minimal exposure to healthy organs, suggesting its potential effectiveness in a clinical setting [2][3] - A case study showed specific uptake in tumor lesions at 24 hours, sustained over four days, with limited accumulation in healthy organs [3][5] Mechanism of Action - MP0712 is engineered for half-life optimization to maintain drug levels in the blood, supporting its intended mechanism of action [3][6] - The data suggests that MP0712 can achieve high tumor uptake even with low DLL3 expression levels, leveraging internalization and optimal binding properties [6] Future Outlook - The company anticipates initial clinical data from the Phase 1/2a study in 2026, which will assess safety and determine a recommended phase 2 dose for MP0712 [7][8] - Molecular Partners is also advancing additional Radio-DARPin programs in 2026 [2][8] Technology and Innovation - The Radio-DARPin platform combines the targeting capabilities of DARPins with the therapeutic potential of 212Pb, aiming to improve the delivery of radioactive payloads to solid tumors [11] - DARPins are designed to offer high specificity and affinity, making them suitable for efficient delivery of therapeutic radionuclides [12]

Core Insights - Molecular Partners AG presented new data on MP0712, a Radio-DARPin targeting DLL3, at the Targeted Radiopharmaceuticals Summit Europe, showcasing promising human imaging results and supporting mechanism of action data [1][2][3] Group 1: Clinical Development - MP0712 is being developed in collaboration with Orano Med for treating small cell lung cancer (SCLC) and other neuroendocrine cancers [1][2] - The Phase 1 Investigational New Drug (IND) application for MP0712 has been filed, with the trial expected to start by the end of 2025, pending regulatory clearance [7][8] - Initial clinical data from the Phase 1/2a study is anticipated in 2026 [7][8] Group 2: Imaging and Mechanism of Action - The imaging data indicates targeted delivery of MP0712 into tumors with minimal exposure to healthy organs, suggesting its potential effectiveness in a clinical setting [2][3] - A case study showed specific uptake of Pb-MP0712 in tumor lesions at 24 hours, sustained over 4 days, with limited accumulation in healthy organs [3][5] - MP0712 is engineered for half-life optimization to maintain sufficient drug levels in the blood, supporting its intended mechanism of action [3][6] Group 3: Technology and Innovation - The Radio-DARPin platform combines the targeting capabilities of DARPins with the therapeutic potential of lead isotopes, aiming to improve delivery of radioactive payloads to tumors [11][12] - DARPins offer advantages in drug design, including high specificity, small size, and stability, which can enhance therapeutic efficacy [12][13]

Core Insights - Molecular Partners AG is presenting updated data from a Phase 1/2a trial of MP0533, a novel T cell engager for acute myeloid leukemia (AML) patients, at the upcoming ASH Annual Meeting [1][2] Group 1: Clinical Trial Details - The trial is a first-in-human, multicenter, open-label study evaluating MP0533 in relapsed/refractory AML and myelodysplastic syndrome (MDS)/AML patients [2] - MP0533 demonstrates an acceptable safety profile across dosing regimens DR 1–9, with preliminary signs of antitumor activity being encouraging [2] - The study is currently administering doses to patients in DR 10 [2] Group 2: Mechanism of Action - MP0533 is a tetra-specific T cell-engaging DARPin that targets three tumor-associated antigens (CD33, CD123, CD70) on AML cells and the immune activator CD3 on T cells [3] - The design allows MP0533 to preferentially bind to AML cells over healthy cells, enhancing T cell-mediated killing while minimizing damage to healthy cells [3] Group 3: Presentation Details - The presentation will occur on December 7, 2025, during the session focused on investigational drugs and cellular therapies for acute myeloid leukemias [4] - The full abstracts will be available on the ASH website starting November 3, 2025 [4] Group 4: About DARPin Therapeutics - DARPin therapeutics represent a new class of custom-built protein drugs that offer multi-functionality and multi-target specificity [5] - The platform is designed for rapid and cost-effective drug discovery, producing candidates with optimized properties and high production yields [5] Group 5: About Molecular Partners AG - Molecular Partners AG is a clinical-stage biotech company focused on developing DARPin therapeutics, primarily in oncology [6] - The company has various programs in different stages of development and collaborates with leading pharmaceutical companies [6]

Core Insights - Molecular Partners AG is advancing its logic-gated CD3 Switch-DARPin T cell engager (TCE) designed for targeted immune activation in solid tumors, particularly ovarian cancer, by presenting new preclinical data at the SITC 2025 meeting [1][4] Group 1: Product Development - The Switch-DARPin TCE utilizes an AND-gate mechanism to activate T cells only when both mesothelin (MSLN) and epithelial cell adhesion molecule (EpCAM) are present, addressing limitations of systemic toxicity and efficacy in TCEs for solid tumors [2][4] - Preclinical data indicate that the Switch-DARPin shows selective T cell cytotoxicity against cells co-expressing MSLN and EpCAM, while exhibiting reduced activity against healthy tissues [3][6] - The T cells exposed to the CD2/CD3 Switch-DARPin demonstrated improved activation and proliferation compared to CD3 engagement alone, suggesting potential to mitigate T cell exhaustion [3][4] Group 2: Safety and Efficacy - Significant tumor regression was observed in a xenograft mouse model expressing MSLN and EpCAM, without systemic cytokine release, indicating a favorable safety profile for the Switch-DARPin [3][6] - The logic-gated approach allows for conditional immune activation, enhancing both efficacy and safety compared to traditional therapies targeting a single tumor antigen [4][6] Group 3: Company Overview - Molecular Partners AG is a clinical-stage biotech company focused on developing DARPin therapeutics, which offer advantages in multi-target specificity and high stability over existing protein-based drugs [5][8] - The company has a diverse pipeline with programs in various stages of development, primarily targeting oncology [8]

Financial Performance - Total revenues for the nine months ended September 30, 2025, were CHF 0, a decrease from CHF 4.97 million in the same period of 2024[11] - Operating expenses for the nine months ended September 30, 2025, were CHF 45.5 million, down 11.5% from CHF 51.4 million in 2024[11] - The net result attributable to shareholders for the nine months ended September 30, 2025, was a loss of CHF 49.0 million, compared to a loss of CHF 42.8 million in 2024[12] - The company reported a basic and diluted net result per share of CHF (1.32) for the nine months ended September 30, 2025, compared to CHF (1.29) in 2024[12] - The Group reported a net foreign exchange loss of TCHF 4,767 for the nine months ended September 30, 2025, compared to no loss in the previous year[35] Cash and Assets - Cash and cash equivalents increased to CHF 82.4 million as of September 30, 2025, from CHF 63.9 million at the beginning of the year[14] - Total assets decreased to CHF 112.2 million as of September 30, 2025, from CHF 158.5 million at the end of 2024[10] - Shareholders' equity as of September 30, 2025, was CHF 95.5 million, down from CHF 141.6 million at the end of 2024[10] Research and Development - Research and development expenses for the nine months ended September 30, 2025, were CHF 30.9 million, a decrease of 18.5% from CHF 38.1 million in 2024[11] - The company has not reported any revenues from research and development collaborations for the third quarter of 2025, compared to CHF 681,000 in the same quarter of 2024[13] - The Group recognized no revenue from the License and Collaboration Agreement with Novartis during the three and nine months ended September 30, 2025, compared to TCHF 681 and TCHF 4,970 for the same periods in 2024, respectively[25] Shareholder Information - As of September 30, 2025, the outstanding issued share capital increased to CHF 4,037,464, divided into 40,374,641 fully paid registered shares, including 2,975,489 treasury shares[29] - The weighted average number of shares used in computing earnings per share for the nine months ended September 30, 2025, was 37,223,971, compared to 33,082,140 for the same period in 2024[37] Expenses and Restructuring - The company incurred restructuring expenses of CHF 2.7 million during the nine months ended September 30, 2025[11] - The Group recognized TCHF 2,733 as a restructuring expense for the nine months ended September 30, 2025, primarily related to personnel costs[41] - The share-based compensation costs for the nine months ended September 30, 2025, amounted to TCHF 3,446, an increase from TCHF 3,045 for the same period in 2024[34] Tax and Related Party Transactions - The Group has a tax loss carry-forward in Switzerland of TCHF 195,126 as of December 31, 2024, with no deferred tax assets recognized due to the improbability of utilizing these losses[36] - No related party transactions occurred during the interim periods presented[39] - No significant events occurred between the balance sheet date and the approval date of the financial statements that would require adjustments[42]

Pipeline Highlights - MP0712 (212Pb x DLL3) IND-enabling studies completed, IND filed[15] - Strategic collaboration with Orano Med expanded to ten 212Pb programs[15] - Lead candidate MP0726 targeting mesothelin (MSLN) nominated based on pre-clinical data[15] - Improved response rate and antitumor activity in low disease burden patients of ongoing Phase 1/2a reported for MP0533 at EHA 2025[15] - Study protocol approved for combo IIT with standard-of-care in cholangiocarcinoma for Switch-DARPin MP0317[15] Financial Position - The company has CHF ~105 million in cash as of September 30, 2025[8, 15] - The company is financed until 2028 through key value inflection points[8] MP0712 Radio-DARPin Therapy - MP0712 induces complete and durable tumor regression in NCI-H82 tumor model at 10 µCi injected every week[27] - Phase 1 study is expected to start in H2 2025, with initial safety and efficacy data in 2026[32] MP0533 Tetra-specific T-cell Engager for AML - In DR 8, 3 of 8 evaluable patients responded after cycle 1: 1 CR and 2 CRh as best overall response[62] - In DR 1-7, 12% (4) patients had response rate, while in DR 8, 37.5% (3) patients had response rate[69]

Core Insights - Molecular Partners AG is advancing its clinical-stage pipeline, focusing on DARPin therapeutics, with significant developments in its Radio-DARPin programs and T-cell engagers [1][2][3] Research & Development Highlights - The IND application for MP0712, a Radio-DARPin targeting DLL3 for small cell lung cancer, has been filed, with a Phase 1 trial expected to start by the end of 2025 [3][7] - Initial clinical imaging data for MP0712 will be presented in November, showcasing its application in compassionate care in South Africa [2][5] - MP0533, a multispecific T-cell engager for acute myeloid leukemia (AML), has shown promising results, with over 30% of evaluable patients achieving a clinical response [10][12] - The company is exploring further dosing strategies for MP0533 to enhance patient outcomes and is planning to present updated data at the ASH Annual Meeting in December [11][12] - MP0317, a tumor-localized agonist, is undergoing an investigator-initiated trial for advanced cholangiocarcinoma, with a focus on progression-free survival [13][14] Corporate Governance Highlights - Martin Steegmaier, Ph.D., has been appointed as Chief Scientific Officer, bringing extensive oncology drug development experience [17] Financial and Business Outlook - For 2025, the company anticipates total operating expenses of CHF 55-60 million, with sufficient cash reserves of CHF 105 million to fund operations until 2028 [18][19]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 6-K REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934 For the Month of August 2025 Commission File Number: 001-40488 MOLECULAR PARTNERS AG (Exact name of registrant as specified in its charter) Wagistrasse 14 8952 Zürich-Schlieren Switzerland Telephone: +41 447557700 (Address of registrant's principal executive offices) Indicate by check mark whether the registrant files or ...

Core Insights - Molecular Partners AG is making significant progress in its clinical programs, particularly with MP0712 and MP0533, with key milestones expected in the near future [2][6] - The company has appointed Martin Steegmaier, Ph.D., as Chief Scientific Officer, enhancing its leadership team [2][15] - Financially, the company is in a strong position with cash reserves projected to last until 2028 [2][19] Research & Development Highlights - MP0533 is in a Phase 1/2a trial for acute myeloid leukemia, showing promising results with over 30% of evaluable patients achieving a clinical response [3][4] - The dosing regimen for MP0533 has been optimized to enhance patient responses, with initial data from cohort 9 expected in Q4 2025 [5][6] - MP0712, a Radio-DARPin therapy for small cell lung cancer, is preparing for an IND filing, with initial clinical data anticipated in H1 2026 [8][9] Corporate Governance Highlights - The appointment of Martin Steegmaier, Ph.D., as CSO is aimed at strengthening the company's focus on oncology drug development [15] - A strategic review led to a planned reduction of up to 40 positions, which is expected to improve operational efficiency and extend the cash runway into 2028 [16] Financial and Business Outlook - For 2025, the company expects total operating expenses between CHF 55-65 million, with a significant portion being non-cash costs [18] - As of June 30, 2025, cash and cash equivalents totaled CHF 114 million, sufficient to fund operations into 2028 [19]