Core Points - Molecular Partners AG, a clinical-stage biotech company, announced that all motions proposed by the Board of Directors at the Annual General Meeting were approved by shareholders with a wide majority [1] - Shareholders confirmed the approval of the annual review, IFRS consolidated financial statements, and the annual statements for the financial year 2024, including the decision to carry forward a net loss of CHF 50,643,414 [2] - The Board of Directors and Management Board members were granted discharge for the financial year 2024, and all members of the Board were re-elected for a one-year term [3] - KPMG AG Zurich was re-elected as statutory auditors for the financial year 2025, and Anwaltskanzlei Keller AG was elected as the independent proxy until the 2026 Annual General Meeting [4] Company Overview - Molecular Partners AG specializes in developing DARPin therapeutics, focusing on medical challenges that other drug modalities cannot address, with oncology as its main area of focus [5] - The company was founded in 2004 and operates offices in Zurich, Switzerland, and Concord, Massachusetts, USA [5]

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Core Insights - Molecular Partners AG is advancing its clinical-stage biotech initiatives, focusing on DARPin therapeutics for oncology, with significant developments in targeted radiotherapy and T cell engagement strategies [1][3]. Group 1: Product Development - The company is preparing to enter first-in-human (FIH) studies in 2025 for MP0712, a Radio-DARPin targeting DLL3 for small cell lung cancer (SCLC) [1]. - A second 212Pb-based Radio-DARPin is in preclinical development, targeting mesothelin (MSLN) in solid tumors [1]. - Additional preclinical data on a CD3 Switch-DARPin T cell engager with CD2 co-stimulation has shown promise in addressing limitations in solid tumor treatments [1][3]. Group 2: Upcoming Presentations - Molecular Partners will present three posters at the American Association for Cancer Research (AACR) Annual Meeting 2025, scheduled for April 25-30 in Chicago, IL [1][2]. - The presentations will cover the development of 212Pb-based Radio-DARPin therapy for MSLN-positive solid tumors and next-generation CD3 Switch-DARPins [2][3]. Group 3: Company Overview - Molecular Partners AG, founded in 2004, is headquartered in Zurich, Switzerland, and Concord, Massachusetts, focusing on innovative DARPin therapeutics to address unmet medical needs [3]. - The company collaborates with leading pharmaceutical firms to enhance its proprietary programs and expand its oncology portfolio [3].

Core Points - Molecular Partners AG is a clinical-stage biotech company focused on developing DARPin therapeutics to address medical challenges that other drug modalities cannot effectively tackle [3] - The company has various programs in different stages of pre-clinical and clinical development, with a primary focus on oncology [3] - The Annual General Meeting for 2025 is scheduled for April 16, 2025, at 9:00 CET in Schlieren, Switzerland [1][2] Financial Calendar - The financial calendar includes key dates such as the Annual General Meeting on April 16, 2025, the Interim Management Statement for Q1 2025 on May 15, 2025, the Half-year results on August 25, 2025, and the Interim Management Statement for Q3 2025 on October 30, 2025 [2] Company Overview - Molecular Partners AG was founded in 2004 and operates offices in Zurich, Switzerland, and Concord, Massachusetts, USA [3] - The company aims to leverage the unique advantages of DARPins to provide innovative solutions for patients through proprietary programs and partnerships with leading pharmaceutical companies [3]

Financial Data and Key Metrics Changes - Revenue for 2024 was exclusively from the Novartis collaboration, with the last part of the upfront payment recognized in 2024, indicating no further revenue from this collaboration in the future [25][30] - Operating expenses were CHF 66 million, within the guidance of CHF 65 million to CHF 70 million, with 74% of these costs being R&D-related [26][30] - The strategic cash balance at the end of the year was CHF 149 million, down from CHF 187 million, indicating a cash burn of around CHF 54 million for the year [28][30] Business Line Data and Key Metrics Changes - The radio DARPin franchise, particularly the DLL3 targeting 712, is ready to enter clinical trials after passing all IND-enabling studies [10][12] - The T cell engager program 533 faced challenges but is being re-evaluated to address target-mediated drug disposition issues [12][60] - The company has secured 10 slots for products using Lead-212 isotope through collaboration with Orano Med, enhancing its product pipeline [11][41] Market Data and Key Metrics Changes - The company is focusing on the DLL3 program for small cell lung cancer, which has a high unmet medical need and low 5-year overall survival rates [43][44] - The mesothelin program is being developed as a second DARPin program, with expectations of significant clinical data in the future [50][52] Company Strategy and Development Direction - The company aims to advance its pipeline towards clinical readouts, with a focus on radio DARPin and T cell engager programs [9][22] - There is a strategic shift away from certain collaborations, such as with Novartis, to focus on more promising targets and partnerships [20][106] - The company plans to explore partnerships for both individual molecules and platform-wide collaborations, depending on the specific needs of potential partners [125][126] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's financial position, allowing continued investment in the pipeline despite broader industry challenges [80] - The first clinical data from the DLL3 program is anticipated in early 2026, with imaging studies expected to provide valuable insights into drug distribution [74][90] - The management highlighted the importance of collaboration with partners like Orano Med and Novartis for future growth and development [83][122] Other Important Information - The company completed a financing round that raised CHF 20 million, enhancing its capital position [15] - The management emphasized the importance of patient involvement in trials and the need for ongoing collaboration with investigators and experts [84][121] Q&A Session Summary Question: Can you provide more color on where you are in the IND submission process and preparations for study initiation? - The company plans to submit IND applications in Q2 2025, with the first part of the program, the imaging part, expected to start in Q3 2025 [90] Question: What are the learnings taken from the Novartis programs before they were discontinued? - The collaboration provided valuable insights into what makes a good radio therapeutic, particularly the importance of tumor-to-kidney ratios and the need for multiple candidate testing [101][102] Question: Are there any on-target off-tumor DLL-3 expressing organs to be concerned about? - The pituitary gland is the only organ with some level of DLL3 expression, but there have been no adverse events reported related to this [118][120] Question: How do you think about partnering in terms of the scope and scale? - The company is exploring both candidate-specific partnerships and broader platform collaborations, depending on the needs of potential partners [125][126]

ANNUAL REPORT partners (UD At a Glance Company Profile Molecular Partners AG (SIX: MOLN, NASDAQ: MOLN) is a clinical-stage biotech company pioneering the design and development of DARPin therapeutics for medical challenges other drug modalities cannot readily address. The Company has programs in various stages of pre-clinical and clinical development, with oncology as its main focus. Molecular Partners leverages the advantages of DARPins to provide unique solutions to patients through its proprietary progra ...

Financial Performance and Funding - As of December 31, 2024, the company had cumulative losses of CHF 246.3 million, with a negative net result attributable to shareholders of CHF 54.0 million for the year ended December 31, 2024[41]. - The company has incurred significant operating losses since inception, primarily due to research and development costs, with a positive net result of CHF 62.0 million for the year ended December 31, 2023[41]. - The company expects to require substantial additional funding to complete the development and commercialization of its product candidates, with a sales agreement in place for gross sales proceeds of up to $100.0 million[48]. - The company anticipates that existing cash and collaborations will fund operations and capital expenditures well into 2027, although this estimate is based on assumptions that may prove incorrect[49]. - Future capital requirements will depend on various factors, including the ability to raise additional funds under potentially unfavorable market conditions[49]. Product Development and Clinical Trials - The company is heavily dependent on the success of its DARPin platform technology for product development, which requires significant additional clinical development and regulatory approval[56]. - All product candidates are in preclinical or various stages of clinical development, with significant uncertainty regarding timelines and outcomes[58]. - Delays in clinical trials can arise from various factors, including regulatory suspensions, patient recruitment issues, and compliance failures, potentially impacting commercialization timelines[59]. - The company has faced challenges in drug substance production, which may lead to regulatory actions and affect clinical trial progress[60]. - Clinical trials must comply with FDA and EMA regulations, and any failure in compliance can lead to increased costs and program delays[62]. Regulatory Challenges and Compliance - The regulatory approval processes for the FDA and EMA are lengthy and unpredictable, with no guarantee that any product candidates will receive approval[94]. - The company must ensure that clinical trial data from foreign trials is accepted by regulatory authorities, or it may face additional costs and delays[93]. - Regulatory approvals, if obtained, will come with ongoing obligations and potential additional expenses related to compliance and post-marketing requirements[98]. - Compliance with healthcare laws, such as the U.S. federal Anti-Kickback Statute, is critical, as violations could lead to significant penalties, including exclusion from government healthcare programs[116]. - Regulatory compliance is critical; failure to adapt to new requirements could result in loss of marketing approvals and profitability[113]. Market and Competitive Landscape - The company faces significant competition from established pharmaceutical and biotechnology companies, which may limit its commercial opportunities[86]. - The company may face competition from biosimilars sooner than expected, which could impact its market position and profitability[139]. - The future commercial success of product candidates will depend on market acceptance among physicians, patients, and healthcare payors, which is influenced by various factors beyond the company's control[130]. - The company faces increasing pricing pressures due to governmental and third-party payor efforts to cap or reduce healthcare costs, which may limit reimbursement for new products[129]. Intellectual Property and Licensing - The patent prosecution process is complex and costly, with uncertainty regarding the issuance and enforceability of patents, potentially affecting competitive positioning[215]. - The company may face challenges in maintaining and enforcing intellectual property rights, which are crucial for protecting its product candidates and technology[214]. - There is a risk that patents may expire before product candidates are commercialized, limiting the company's ability to exclude competitors from the market[222]. - The company may not be able to secure licenses for third-party patents on commercially reasonable terms, impacting its ability to develop or commercialize products[229]. Environmental and Safety Regulations - The company faces risks related to environmental, health, and safety laws, which could lead to significant liabilities and compliance costs[157]. - The company may experience delays in research and development activities due to potential restrictions on animal testing, impacting product development timelines[156]. - The company does not have insurance coverage for pollution cleanup and removal, which could expose it to significant liabilities in the future[162]. Data Privacy and Security - Compliance with data privacy laws such as GDPR and CCPA is critical, and any deficiencies in privacy policies could lead to investigations and enforcement actions[180]. - The company may face challenges in transferring personal data across jurisdictions due to data localization laws, complicating compliance efforts[178]. - Non-compliance with data privacy obligations could result in severe consequences, including government enforcement actions and reputational damage[183]. Strategic Partnerships and Collaborations - The company relies on collaborative partners for the development and commercialization of its research programs and product candidates, which poses risks to its business and financial condition[200]. - Collaborative research relationships are established with institutions such as the University of Bern and Novartis, primarily for Radio-DARPin therapies, indicating a focus on strategic partnerships[201]. - The company faces significant competition in securing collaborative partners, which may affect the timing and terms of agreements, impacting product development and commercialization[203].

Core Insights - Molecular Partners AG has made significant advancements in 2024, particularly in the development of its Radio-DARPins and next-generation immuno-oncology programs, positioning the company for key value inflection points [2][3] - The company reported a total revenue of CHF 5.0 million for 2024, a decrease from CHF 7.0 million in 2023, while total operating expenses were CHF 66.2 million, down from CHF 68.1 million in the previous year [24][28] Research & Development Highlights - The IND application for MP0712, a Pb Radio-DARPin therapy targeting DLL3, is in preparation, with submission anticipated in H1 2025 [4][5] - The second RDT program targeting mesothelin (MSLN) is also in development, with initial preclinical data to be presented at the AACR in Q2 2025 [6][8] - MP0533, a multispecific T cell engager, is undergoing a Phase 1/2a clinical trial for relapsed/refractory acute myeloid leukemia (AML), with data on an amended dosing scheme expected in 2025 [12][14] Financial Highlights - The company raised approximately $20 million in October 2024 to support the development of its radiopharmaceutical pipeline [23] - As of December 31, 2024, cash and cash equivalents totaled CHF 149.4 million, sufficient to fund operations into 2027 [26] - The net loss for 2024 was CHF 54.0 million, an improvement from a net loss of CHF 62.0 million in 2023 [24][28] Corporate Governance & Leadership - Philippe Legenne was appointed Chief Medical Officer in August 2024, bringing significant clinical experience to the company [21] - A putative class action complaint against the company was dismissed in February 2024, closing the case in the company's favor [22] Strategic Partnerships - The strategic partnership with Orano Med has been expanded to co-develop up to ten radiotherapy programs, with Molecular Partners retaining commercialization rights to MP0712 and the MSLN RDT program [9][11]

Core Points - Molecular Partners AG is a clinical-stage biotech company focused on developing DARPin therapeutics, which are custom-built protein drugs aimed at addressing medical challenges that other drug modalities cannot effectively tackle [6] - The company will present at several upcoming investor conferences, including the TD Cowen 44th Annual Health Care Conference and the Leerink Partners Global Healthcare Conference [3][5] - A conference call to discuss the full-year 2024 financial results is scheduled for March 7, 2025, with the Annual Report to be published on March 6, 2025 [2][4] Event Details - At the TD Cowen 44th Annual Health Care Conference in Boston, MA, CEO Patrick Amstutz and CMO Dr. Philippe Legenne will participate in a fireside chat on March 3, 2025, at 9:10 am ET [3] - The full-year 2024 financial results conference call will take place on March 7, 2025, at 8:00 am ET, with registration details provided for participants [4][8] - At the Leerink Partners Global Healthcare Conference in Miami, FL, the same executives will engage in a fireside chat on March 10, 2025, at 10:40 am ET [5] Company Overview - Molecular Partners AG was founded in 2004 and has offices in Zurich, Switzerland, and Concord, Massachusetts, USA [6] - The company is pioneering the design and development of DARPin therapeutics, with a primary focus on oncology, and collaborates with leading pharmaceutical companies to enhance its proprietary programs [6]

Company Updates - Molecular Partners provided updates on its programs, development plans, and key milestones for 2025, to be presented at the 43rd Annual J P Morgan Healthcare Conference [1] - The company strengthened its partnership with Orano Med for co-development of up to ten 212Pb-based Radio-DARPins, with MP0712 being the most advanced program targeting DLL3 [2][3] - MP0712, a 212Pb Radio-DARPin candidate targeting DLL3, is preparing for an IND application submission in H1 2025, with the first-in-human study to follow regulatory clearance [6] - The second Radio-DARPin program targets Mesothelin (MSLN), with further details to be unveiled at the AACR Annual Meeting in Q2 2025 [3][9] - MP0533, a multispecific T cell engager, showed improved response rates and depth in cohort 8 of its Phase 1/2a trial for relapsed/refractory AML, with additional dose densification planned for cohort 9 [4][11][12] - The Switch-DARPin platform demonstrated preclinical proof-of-concept for conditional T cell activation in solid tumors, with further data expected in Q2 2025 [14][15] - MP0317, a localized CD40 agonist, completed Phase 1 trials in solid tumors, with potential combination trials planned for 2025 [16][17] Financial and Operational Highlights - As of December 31, 2024, Molecular Partners reported cash and cash equivalents of CHF 149 million (unaudited), with full-year financial results to be released on March 6, 2025 [5] - The company continues to progress its Radio-DARPin Therapy (RDT) portfolio in partnership with Novartis and is evaluating additional targets for RDT programs [10] Scientific and Clinical Progress - MP0712 demonstrated high affinity and specificity for DLL3 in preclinical studies, with homogeneous expression in small cell lung cancer tumors and low expression in healthy tissues [7] - MP0533 is a tetraspecific T cell engager targeting CD33, CD123, CD70, and CD3, designed to preferentially kill AML cells expressing at least two of the three tumor-associated antigens [13] - The CD3 Switch-DARPin molecule showed potent tumor regression in vivo with reduced cytokine release in healthy tissues, potentially reducing the risk of cytokine release syndrome (CRS) [15] - MP0317 activates immune cells within the tumor microenvironment by anchoring to fibroblast activation protein (FAP), offering potential for greater efficacy with fewer side effects compared to systemic therapies [16]