Core Insights - Molecular Partners AG has presented promising first patient imaging and dosimetry data for its DLL3-targeted Radio-DARPin candidate MP0712 at the 8th Theranostics World Congress, indicating strong potential for treating small cell lung cancer and other DLL3-expressing neuroendocrine cancers [1][2][4] Clinical Development - The data from five evaluable patients show favorable tumor uptake of MP0712 with limited uptake in healthy tissues, supporting its therapeutic potential [2][3] - The biodistribution and dosimetry data validate the ongoing U.S. Phase 1/2a study of MP0712, which aims to assess safety and determine a recommended phase 2 dose [4][5] Presentation Details - Two posters and an oral presentation were made at the congress, highlighting the specific tumor accumulation and dosimetry data that support the clinical development of MP0712 [5][7] - The oral presentation titled "From DARPins to Radio-DARPin Therapeutics" was scheduled for January 31, 2026, focusing on the progress of MP0712 [7] Future Outlook - Initial clinical data from the Phase 1/2a study of MP0712 is expected in 2026, with the company planning to share safety and activity data as the study progresses [4][5] - The company aims to establish itself as a leader in alpha-targeted therapies for small cell lung cancer and neuroendocrine malignancies [4]

Core Insights - Molecular Partners AG has presented promising first patient imaging and dosimetry data for its DLL3-targeted Radio-DARPin candidate MP0712 at the 8th Theranostics World Congress, indicating strong potential for treating small cell lung cancer and other DLL3-expressing neuroendocrine cancers [1][2][4] Group 1: Clinical Development - The data from five evaluable patients support the clinical development plans for MP0712, which utilizes the therapeutic isotope 212Pb [2][4] - The biodistribution of MP0712 shows specific tumor uptake with limited accumulation in healthy tissues, reinforcing its therapeutic potential [3][4] - The ongoing Phase 1/2a study in the U.S. aims to assess safety and determine a recommended phase 2 dose for MP0712, with initial clinical data expected in 2026 [4][5] Group 2: Presentation Details - The data was presented through two posters and an oral presentation at the Theranostics World Congress, highlighting the favorable distribution profile and dosimetry data of MP0712 [2][5] - An oral presentation titled "From DARPins to Radio-DARPin Therapeutics" was conducted, showcasing the progress of MP0712 [7] Group 3: Company Strategy and Future Outlook - The CEO of Molecular Partners expressed optimism about the data, emphasizing the company's ambition to lead in alpha-targeted therapies for small cell lung cancer and neuroendocrine malignancies [4] - The company plans to share initial Phase 1 safety and activity data in 2026 as it advances its Radio-DARPin platform [4][5] - Molecular Partners' Radio-DARPins are designed to address limitations of traditional radioligand therapy, enhancing tumor uptake while minimizing toxicity [9][10]

Summary of Molecular Partners FY Conference Call Company Overview - **Company Name**: Molecular Partners (NasdaqGS:MOLN) - **Focus**: Development of DARPin candidates, particularly in the field of radiotherapy - **Financial Position**: Over $100 million in cash (approximately CHF 93 million) available for investment in R&D [4][30] Key Industry Insights - **Biotech Sector Outlook**: Increased confidence in a turnaround for the biotech sector in 2026, following a challenging period [3] - **Radiotherapy Market**: Positive feedback and renewed interest in radiotherapy, highlighted by the successful IPO of Aktis Oncology [3] Core Product Focus - **Primary Candidate**: MP0712, a DLL3-targeted DARPin, is expected to drive value creation in the upcoming year [4][6] - **Pipeline Overview**: Emphasis on MP0712, with additional focus on MPO 317 and MPO 533, which are also in development [6][11] Product Development and Clinical Trials - **MPO 317**: Initially considered a dead program, it has been revived due to promising phase one data showing immune activation in colorectal carcinoma. A new trial will involve 75 patients across 11 centers in France, with results expected in 2027 [10][11] - **MPO 533**: A multispecific DARPin targeting acute myeloid leukemia (AML), designed to eradicate residual disease clones. The focus will be on low disease burden patients [11][12] Radiotherapy Mechanism - **Mechanism of Action**: MP0712 utilizes a DARPin vector linked to a radioisotope (Lead-212) to target DLL3 in small cell lung cancer. The approach aims to combine the efficacy of T cell engagers with the durability of antibody-drug conjugates (ADCs) [14][16][18] - **Clinical Strategy**: The company plans to initiate a phase one dose escalation trial, starting with a 75-megabecquerel dose, with a fast-to-market strategy for small cell lung cancer [27][30] Safety and Efficacy Considerations - **Safety Profile**: The rapid decay of Lead-212 is expected to result in minimal hematological toxicity, with recovery of blood values anticipated [34][37] - **Patient Experience**: Radiotherapy is expected to offer a better quality of life for patients compared to T cell engagers, which often cause acute side effects [37] Partnerships and Collaborations - **Orano Med Partnership**: A 50/50 partnership focused on the supply of Lead-212, with Orano Med providing a robust supply chain and infrastructure for the isotope [40][43] - **Future Collaborations**: The company is open to exploring partnerships for other isotopes, such as actinium, to enhance treatment options [45][46] Future Directions - **Expansion of Indications**: Beyond small cell lung cancer, there are plans to explore other neuroendocrine tumors with DLL3 expression [47][48] - **Innovative Imaging Techniques**: The use of imaging agents to select patients with DLL3 expression is seen as pivotal for maximizing treatment efficacy [48] Conclusion - **Focus for 2026**: The primary focus will be on MP0712, with expectations for first-in-human results and safety data in the first half of the year, followed by activity data in the second half [30]

Company Overview - Molecular Partners is a clinical-stage biotech company founded in 2004, with operations and listings in Switzerland (SIX, 2014) and the US (Nasdaq, 2021)[12] - The company is financed with approximately USD 116 million / CHF 93 million to reach upcoming value inflection points[12] - Molecular Partners focuses on oncology with differentiated assets like MP0712 (targeted radiotherapy) and MP0533 (next-gen immune cell engagers)[12] Radio-DARPin Therapeutics (RDT) - The company is developing Radio-DARPin therapeutics, which are designed for precise delivery of potent radio-isotopes to tumors[26, 27] - Molecular Partners has a global partnership with Orano Med to develop 212Pb Radio-DARPin therapeutics, with a 50:50 cost and share split for 4 programs[33, 36] - MP0712, a 212Pb x DLL3 Radio-DARPin, is in Phase 1/2a clinical trials in the US for small cell lung cancer (SCLC) and other neuroendocrine cancers (NECs), with early data expected in 2026[43, 77] - Preclinical data for MP0712 shows high tumor accumulation (Tumor > Kidney) and reduction of established tumors in mice[51] - MP0726, a 212Pb x MSLN Radio-DARPin, is being developed for ovarian cancer and is progressing towards first-in-human (FIH) imaging[86, 94] Other Pipeline Programs - MP0317, a FAP-localized CD40 agonist, is in a Phase 2 combo study in advanced biliary tract cancer, with interim analysis expected by YE 2027[104, 117, 123] - MP0533, a tetra-specific T-cell engager for AML, is in Phase 1/2a, with decisional data expected in H1 2026[124] - The company is developing Switch-DARPin platform for next-generation T cell engagers, with a lead candidate selection expected in H1 2026 and an update at AACR 2026[99, 140] Financial Outlook - The company's cash of approximately USD 116 million (CHF 93 million) ensures funding until 2028[99]

Core Insights - Molecular Partners AG is advancing its clinical-stage pipeline of DARPin therapeutics, focusing on targeted radiotherapy and immune cell engagers, with significant milestones expected in 2026 [1][20]. Financial Overview - As of December 31, 2025, the company reported cash and cash equivalents of CHF 93.1 million, sufficient to fund operations until 2028 [3]. Clinical Development Updates - The Phase 1/2a trial for MP0712, a Radio-DARPin targeting DLL3 for small cell lung cancer (SCLC), has commenced, with initial patient dosing expected in Q1 2026 and initial clinical data anticipated in the same year [2][4][7]. - MP0726, another Radio-DARPin targeting mesothelin (MSLN) for ovarian cancer, is also in development, with preclinical data presented at the 2025 SNMMI meeting [6]. - An investigator-initiated Phase 2 trial for MP0317 in cholangiocarcinoma is ongoing, with the first patient treated in early 2026 [10][11]. - MP0533, a tetra-specific T cell engager for acute myeloid leukemia (AML), is in a Phase 1/2a trial, with updates on its clinical development expected in H1 2026 [12][14]. Scientific Advisory Board - The formation of a scientific advisory board, chaired by Prof. Ken Herrmann, aims to accelerate the development of targeted radiotherapeutics [8]. DARPin Technology - Molecular Partners' DARPin therapeutics are designed for high specificity and stability, enabling effective delivery of radioactive payloads to tumors while minimizing damage to healthy tissues [19].

Core Insights - Molecular Partners AG has established a Scientific Advisory Board (SAB) for its radiopharmaceuticals, chaired by Prof. Ken Herrmann, a leading expert in nuclear medicine [1][4]. Group 1: Scientific Advisory Board Formation - The SAB will guide the development of Molecular Partners' Radio-DARPin platform, focusing on transitioning from early clinical validation to strategic clinical development [3][5]. - Prof. Ken Herrmann expressed enthusiasm for the potential of Radio-DARPins to deliver targeted radiopharmaceuticals effectively [2][8]. Group 2: Radio-DARPin Technology - Molecular Partners' Radio-DARPin candidates, including MP0712 and MP0726, are designed to target specific tumor markers, with MP0712 aimed at DLL3 for small cell lung cancer and MP0726 targeting mesothelin in various cancers [8]. - The technology aims to balance the delivery of potent radioactive payloads to tumors while minimizing damage to healthy tissues [8]. Group 3: Expertise of SAB Members - The SAB includes experts such as James Cook, Jason Lewis, and Michael Morris, who bring extensive clinical and industry experience to support the company's strategic development [5][6]. - Ken Herrmann's leadership is expected to be crucial in shaping the company's direction as it moves towards pivotal development decisions [5].

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]

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]