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]

Core Insights - Molecular Partners AG presented three posters at the AACR Annual Meeting 2025, showcasing advancements in their DARPin therapeutics, particularly in the context of small cell lung cancer and solid tumors [1][2][8] Group 1: Radio-DARPin Programs - The first poster highlighted positive IND-enabling data for MP0712, a Radio-DARPin targeting DLL3, which is on track to provide initial clinical data in the second half of 2025 [1][2][8] - The second poster presented initial preclinical data on a Pb-based Radio-DARPin targeting mesothelin (MSLN), indicating substantial uptake in MSLN-positive tumors with limited accumulation in other organs [1][2][4] - MP0712 demonstrated high tumor uptake and a favorable safety profile in mouse models, with efficacy and tumor reduction correlating with DLL3 expression levels [3][4] Group 2: T Cell Engager Program - The third poster included preclinical proof-of-concept data on a logic-gated CD3 Switch-DARPin T cell engager, which activates T cells specifically in the presence of tumor-associated antigens, enhancing tumor specificity [5][8] - The Switch-DARPin approach allows for CD2 co-stimulation, leading to sustained T cell activation and preventing dysfunction, with significant tumor regression observed in mouse models [5][8] Group 3: Strategic Partnerships - Molecular Partners is co-developing the Radio-DARPin programs with Orano Med, emphasizing the strategic partnership's role in advancing their therapeutic innovations [2][8] - The company is leveraging the unique properties of DARPins to selectively bind to tumor targets while minimizing off-target effects, particularly in the context of MSLN-targeted therapies [4][8]

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]

Core Viewpoint - Shares of Molecular Partners AG (MOLN) have recently declined by 11.3% over the past week, but the formation of a hammer chart pattern suggests potential support and a possible trend reversal in the future [1][2]. Technical Analysis - The hammer chart pattern indicates a potential bottoming out, with selling pressure likely subsiding, which supports a bullish outlook for the stock [2][5]. - A hammer pattern typically forms during a downtrend, where the stock opens lower, makes a new low, but then closes near or above the opening price, indicating buying interest [4][5]. - The effectiveness of the hammer pattern can vary based on its placement on the chart and should be used alongside other bullish indicators [6]. Fundamental Analysis - Recent upward revisions in earnings estimates for MOLN are a strong bullish indicator, as trends in earnings estimate revisions correlate with near-term stock price movements [7]. - Over the last 30 days, the consensus EPS estimate for the current year has increased by 13.8%, indicating that analysts expect better earnings than previously predicted [8]. - MOLN holds a Zacks Rank of 2 (Buy), placing it in the top 20% of over 4,000 ranked stocks, which typically outperform the market [9].

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]

[At a Glance](index=2&type=section&id=At%20a%20Glance) [Company Profile & DARPin Therapeutics](index=2&type=section&id=Company%20Profile%20%26%20DARPin%20Therapeutics) Molecular Partners AG is a clinical-stage biotech company specializing in the design and development of DARPin (Designed Ankyrin Repeat Protein) therapeutics, a new class of custom-built protein drugs, primarily focusing on oncology by leveraging DARPins' unique properties - The company pioneers DARPin therapeutics, focusing on oncology programs in various stages of pre-clinical and clinical development[4](index=4&type=chunk) - DARPin therapeutics are a new class of protein drugs with advantages like multi-target specificity, high affinity, small size, and stability, which have been clinically validated across several therapeutic areas[5](index=5&type=chunk) [Highlights in 2024](index=2&type=section&id=Highlights%20in%202024) Molecular Partners achieved significant R&D, leadership, and financial milestones in 2024, advancing lead candidates, expanding key collaborations, strengthening leadership, and securing a **$20 million** capital raise to extend its operational runway into 2027 - Nominated **MP0712** (DLL3-targeting) as the first lead Radio-DARPin candidate and advanced it into IND-enabling studies with partner Orano Med[6](index=6&type=chunk) - Expanded the strategic collaboration with Orano Med to co-develop up to ten 212Pb-based radiotherapy products[10](index=10&type=chunk) - Presented encouraging initial response rate data from cohort 8 of the Phase 1/2a trial of **MP0533** for patients with relapsed/refractory AML[10](index=10&type=chunk) - Secured a stronger financial position through a **$20 million** capital raise, extending the cash runway well into 2027[10](index=10&type=chunk)[11](index=11&type=chunk) - Appointed Dr. Philippe Legenne as Chief Medical Officer in August 2024[8](index=8&type=chunk) [2025 Outlook](index=3&type=section&id=2025%20Outlook) Molecular Partners anticipates a productive 2025, with key milestones including first-in-human studies for **MP0712**, preclinical data for a second Radio-DARPin, and further **MP0533** trial data, projecting operating expenses between **CHF 55-65 million** - Lead Radio-DARPin **MP0712** is expected to enter its first-in-human study in 2025, with initial clinical data anticipated by year-end[11](index=11&type=chunk) - Data from the Phase 1/2a trial of **MP0533**, including results from the amended dosing scheme, will be presented in 2025[12](index=12&type=chunk) - Preclinical data on the second Radio-DARPin candidate targeting MSLN will be presented in H1 2025[11](index=11&type=chunk) - Full-year 2025 operating expenses are expected to be between **CHF 55-65 million**[11](index=11&type=chunk) [Shareholder Letter](index=7&type=section&id=Shareholder%20Letter) The shareholder letter highlights 2024 achievements and 2025 outlook, including an expanded partnership with Orano Med, progress with **MP0533** and the Switch-DARPin platform, and a **$20 million** capital raise securing funding into 2027 - Expanded partnership with Orano Med to develop up to ten targeted alpha radiotherapy programs, with **MP0712** (targeting DLL3) set to enter clinical trials in 2025[17](index=17&type=chunk)[18](index=18&type=chunk) - Presented positive data for **MP0533** in AML, with an amended dosing protocol showing increased response rates, and advanced the Switch-DARPin platform with preclinical proof-of-concept[22](index=22&type=chunk)[23](index=23&type=chunk)[24](index=24&type=chunk) - Strengthened the financial position by raising approximately **$20 million**, resulting in a cash position of **CHF 149 million** at year-end 2024, which is expected to fund operations well into 2027[29](index=29&type=chunk) - Key upcoming milestones in 2025 include submitting the IND application for **MP0712** in H1, presenting data on the amended **MP0533** dosing scheme, and initiating an investigator-led trial for **MP0317**[27](index=27&type=chunk)[28](index=28&type=chunk) [Financial Summary](index=11&type=section&id=Financial%20Summary) [Results and Overview](index=11&type=section&id=Results%20and%20Overview) The company reported a net loss of **CHF 54.0 million** for FY 2024, an improvement from the **CHF 62.0 million** loss in FY 2023, with total revenues decreasing to **CHF 5.0 million**, operating expenses stable at **CHF 66.2 million**, and a cash position of **CHF 149.4 million** providing a runway into 2027 Key Financials (FY 2024 vs FY 2023) | Key Financials (CHF million) | FY 2024 | FY 2023 | Change | | :--- | :--- | :--- | :--- | | Total revenues and other income | 5.0 | 7.0 | (2.0) | | Total operating expenses | (66.2) | (68.1) | 1.9 | | Operating result | (61.2) | (61.1) | (0.1) | | Net result | (54.0) | (62.0) | 8.0 | | Basic net result per share (in CHF) | (1.59) | (1.89) | 0.30 | | Net cash from operating activities | (59.2) | (59.0) | (0.2) | | Cash and cash equivalents (incl. short-term deposits) | 149.4 | 186.9 | (37.5) | | Total shareholders' equity | 141.6 | 176.4 | (34.8) | - The Group's cash position of **CHF 149.4 million** as of December 31, 2024, is expected to support operations well into 2027, excluding potential receipts from R&D partners[38](index=38&type=chunk) [Financial Performance Details](index=12&type=section&id=Financial%20Performance%20Details) In 2024, revenues of **CHF 5.0 million** were solely from the Novartis collaboration, which concluded in Q3 2024, while operating expenses decreased slightly to **CHF 66.2 million**, and a net financial gain of **CHF 7.2 million** contributed to a reduced net loss of **CHF 54.0 million** - Total revenues of **CHF 5.0 million** in 2024 were exclusively from the Novartis radioligand therapy collaboration, which concluded in Q3 2024[39](index=39&type=chunk) - Total operating expenses decreased by **CHF 1.9 million** to **CHF 66.2 million**. R&D expenses were flat at **CHF 48.6 million**, while SG&A expenses decreased by **9%** to **CHF 17.6 million**[41](index=41&type=chunk)[42](index=42&type=chunk) - The company recorded a net financial gain of **CHF 7.2 million** in 2024, a significant turnaround from a loss of **CHF 0.9 million** in 2023, primarily due to foreign exchange gains and interest income[43](index=43&type=chunk) - The net loss for 2024 was **CHF 54.0 million**, an improvement from the **CHF 62.0 million** net loss in 2023[45](index=45&type=chunk) [Balance Sheet and Cash Flow](index=13&type=section&id=Balance%20Sheet%20and%20Cash%20Flow) As of December 31, 2024, the Group's balance sheet remained debt-free with total shareholders' equity of **CHF 141.6 million**, while total cash and short-term deposits decreased by **CHF 37.5 million** to **CHF 149.4 million**, and a **CHF 14.4 million** net cash inflow from financing activities was driven by a capital raise - Total cash and short-term deposits decreased by **CHF 37.5 million** to **CHF 149.4 million** at year-end 2024[46](index=46&type=chunk) - The balance sheet remained debt-free, with total shareholders' equity at **CHF 141.6 million**[47](index=47&type=chunk) - Net cash outflow from operating activities was **CHF 59.2 million**, nearly unchanged from **CHF 59.0 million** in 2023[48](index=48&type=chunk) - Net cash inflow from financing activities was **CHF 14.4 million**, primarily due to the capital raise in October 2024[50](index=50&type=chunk) [Financial Risk Management](index=14&type=section&id=Financial%20Risk%20Management) The Group's financial risk management focuses on mitigating pre-revenue stage risks, including financing, foreign exchange, and liquidity, through natural hedging, high-rated bank deposits, and a strong cash position funding operations into 2027 - The Group is exposed to financing risk due to a lack of constant revenue, but this is mitigated by a strong cash position[52](index=52&type=chunk) - Foreign exchange risk (CHF, EUR, USD) is managed primarily through natural hedging by matching cash flows in different currencies[54](index=54&type=chunk) - Credit risk is low as all cash and cash equivalents are held with three major Swiss banks with high credit ratings (**A+ to AAA**)[58](index=58&type=chunk) - Liquidity risk is deemed low, with the **CHF 149.4 million** cash position expected to fund the Group well into 2027[58](index=58&type=chunk) [Financial Outlook 2025 and Calendar](index=15&type=section&id=Financial%20Outlook%202025%20and%20Calendar) For FY 2025, Molecular Partners projects total operating expenses between **CHF 55-65 million**, including approximately **CHF 7 million** in non-cash costs, and has outlined its financial calendar for the year - Expected total operating expenses for FY 2025 are between **CHF 55-65 million**, including about **CHF 7 million** in non-cash costs[55](index=55&type=chunk) Financial Calendar 2025 | Date | Event | | :--- | :--- | | March 25, 2025 | Publication of Annual General Meeting Invitation | | April 16, 2025 | Annual General Meeting | | May 15, 2025 | Interim Management Statement Q1 2025 | | August 25, 2025 | Publication of Half-year Results 2025 | | October 30, 2025 | Interim Management Statement Q3 2025 | [Research and Development](index=17&type=section&id=Research%20and%20Development) [Overview and R&D Strategy](index=17&type=section&id=Overview%20and%20R%26D%20Strategy) Molecular Partners, a clinical-stage biotech, pioneers DARPin therapeutics with an R&D strategy focused on oncology, aiming for early clinical readouts and leveraging partnerships to build a broad pipeline based on DARPins' intrinsic advantages - The company's approach has been validated through seven clinical-stage candidates tested in over **2,500 patients**, observed to be highly active and generally well-tolerated[61](index=61&type=chunk) - Key intrinsic advantages of DARPins include their derivation from natural binding proteins, high affinity and specificity, small size, multispecificity, 'either-or' specificity for conditional activation, and high stability[63](index=63&type=chunk)[64](index=64&type=chunk)[65](index=65&type=chunk) - The R&D strategy prioritizes programs that can demonstrate single-agent activity early in clinical development to enable swift decision-making[70](index=70&type=chunk)[71](index=71&type=chunk) - The company seeks to combine its capabilities with world-class partners to accelerate the development of DARPins as a class and deliver a broad pipeline of innovative therapies[72](index=72&type=chunk) [Pipeline Update](index=19&type=section&id=Pipeline%20Update) The company's oncology pipeline focuses on the Radio-DARPin Therapy (RDT) platform, the tetraspecific T cell engager **MP0533**, and the next-generation Switch-DARPin platform, with **MP0712** and **MP0533** as lead candidates - The oncology pipeline is led by the Radio-DARPin Therapy (RDT) platform, T cell engager **MP0533**, and the Switch-DARPin platform for immune cell engagers[73](index=73&type=chunk) [Radio-DARPin Therapy (RDT)](index=20&type=section&id=Radio-DARPin%20Therapy%20(RDT)) The RDT platform uses DARPins to selectively deliver radioactive payloads to tumors, with lead candidate **MP0712** (targeting DLL3) co-developed with Orano Med for SCLC, and an expanded partnership covering up to ten 212Pb-based RDT programs - **MP0712** is the first DLL3-targeting Radio-DARPin, co-developed with Orano Med. An IND application is planned for H1 2025, with a first-in-human study to follow[80](index=80&type=chunk)[81](index=81&type=chunk) - The second RDT program targets mesothelin (MSLN), which is overexpressed in several cancers. Preclinical data will be presented in Q2 2025[83](index=83&type=chunk) - The strategic collaboration with Orano Med was expanded in January 2025 to co-develop up to **ten** 212Pb-based RDT programs[84](index=84&type=chunk) [MP0533](index=22&type=section&id=MP0533) **MP0533**, a novel tetra-specific T cell-engaging DARPin for relapsed/refractory AML, is undergoing a Phase 1/2a trial with an amended dosing protocol showing increased response rates, and further data expected in 2025 - **MP0533** is a tetra-specific T cell engager targeting three AML antigens (CD33, CD123, CD70) and the T cell activator CD3[88](index=88&type=chunk) - The ongoing Phase 1/2a trial is being amended to improve drug exposure based on learnings from dose escalation. Initial data from cohort 8 with more frequent dosing showed increased response rates[90](index=90&type=chunk) - Updated data on the amended dosing scheme are expected in 2025[90](index=90&type=chunk) [Switch-DARPin Platform](index=23&type=section&id=Switch-DARPin%20Platform) The Switch-DARPin platform employs a logic-gated design for conditional immune activation, demonstrating preclinical proof-of-concept for potent tumor regression with reduced off-tumor toxicity, while the first program, **MP0621**, is being evaluated for partnering - The platform uses a dual-binding logic-gated DARPin to provide an 'on/off' function for conditional activation of immune responses[91](index=91&type=chunk) - A novel CD3 Switch-DARPin T cell engager showed preclinical proof-of-concept in a solid tumor model, inducing potent tumor regression with reduced off-tumor toxicity. Further data will be presented in Q2 2025[95](index=95&type=chunk)[96](index=96&type=chunk) - The first Switch-DARPin program, **MP0621**, is being evaluated for partnering after data did not support its use as a treatment for AML[99](index=99&type=chunk) [MP0317](index=24&type=section&id=MP0317) **MP0317** is designed for tumor-localized immune activation by targeting CD40 and FAP, aiming for greater efficacy with fewer side effects, with potential investigator-initiated combination trials under discussion for 2025 - **MP0317** is designed to activate immune cells specifically within the tumor microenvironment by targeting both CD40 and FAP[102](index=102&type=chunk) - Comprehensive biomarker analyses from the completed Phase 1 dose escalation trial were presented at SITC in November 2024[103](index=103&type=chunk) - The company is discussing potential investigator-initiated combination trials for **MP0317** in 2025[104](index=104&type=chunk) [Corporate Sustainability](index=26&type=section&id=Corporate%20Sustainability) Molecular Partners is committed to corporate sustainability across human capital, product safety, access to medicine, and business ethics, overseen by the Board's Finance and Audit Committee [Human Capital and Employee Base](index=27&type=section&id=Human%20Capital%20and%20Employee%20Base) The company fosters a supportive work environment with comprehensive benefits, flexible work, and training, while its total full-time equivalent (FTE) employee base decreased by **5%** to **158.5** in 2024, with **84%** in R&D - Offers generous employee benefits, flexible/hybrid work arrangements, and training programs including LinkedIn Learning[111](index=111&type=chunk)[113](index=113&type=chunk) - Total FTEs reduced by **5%** to **158.5**, with approximately **84%** in R&D roles[116](index=116&type=chunk) [Product, Data, and Supply Chain](index=28&type=section&id=Product%20%2C%20Data%20%2C%20and%20Supply%20Chain) Molecular Partners prioritizes data protection and cybersecurity, ensures product quality and safety through a robust QMS, and manages its supply chain with quality audits of Western European CDMOs - Maintains high standards of data protection with cutting-edge IT systems, employee training, and a disaster recovery plan[118](index=118&type=chunk)[119](index=119&type=chunk) - Ensures product quality and safety through a comprehensive QMS, well-trained personnel, and robust oversight of vendors and trials[123](index=123&type=chunk) - All CDMOs are based in Western Europe and are audited for quality, focusing on GxP aspects[122](index=122&type=chunk) [Business Ethics and Access to Medicine](index=29&type=section&id=Business%20Ethics%20and%20Access%20to%20Medicine) The company is committed to global access to medicine, demonstrated by waiving ensovibep royalties in developing regions, and adheres to a strict code of conduct, with its board comprising seven male and one female director as of year-end 2024 - Demonstrated commitment to global access to medicine by waiving future royalties from ensovibep in developing regions during the COVID-19 pandemic[121](index=121&type=chunk) - Adheres to a strict code of conduct covering privacy, anti-bribery, whistleblowing, and human rights[126](index=126&type=chunk) - As of year-end 2024, the board of directors included seven male and one female director[125](index=125&type=chunk) [Corporate Governance Report](index=31&type=section&id=Corporate%20Governance%20Report) [Group Organization and Shareholders](index=31&type=section&id=Group%20Organization%20and%20Shareholders) Molecular Partners AG, a Swiss company listed on SIX Swiss Exchange and NASDAQ, had a market capitalization of **CHF 164 million** as of December 31, 2024, with Biotechnology Value Funds and Suvretta Capital Management as significant shareholders - The company is listed on the SIX Swiss Exchange (MOLN) and NASDAQ (MOLN), with a market capitalization of **CHF 164 million** as of Dec 31, 2024[128](index=128&type=chunk)[129](index=129&type=chunk) Significant Shareholders (as of Dec 31, 2024) | Beneficial Owner | % of Voting Rights | | :--- | :--- | | Mark N. Lampert (Biotechnology Value Funds) | 21.74% | | Suvretta Capital Management, LLC | 10.71% | | UBS Fund Management (Switzerland) AG | 4.82% | | Novartis AG | 4.35% | [Capital Structure](index=32&type=section&id=Capital%20Structure) As of December 31, 2024, the company's issued share capital was **CHF 4,036,309.50**, divided into **40,363,095** registered shares, with the Board authorized to adjust capital and conditional capital available for employee plans and financing - On Dec 31, 2024, the issued share capital was **CHF 4,036,309.50**, comprising **40,363,095** registered shares with a par value of **CHF 0.10** each[136](index=136&type=chunk) - The Board of Directors is authorized to adjust the share capital within a predefined capital range (lower limit: **CHF 3.64 million**, upper limit: **CHF 5.45 million**) until April 17, 2029[137](index=137&type=chunk) - The company has conditional share capital of **CHF 400,000** for employee equity plans and **CHF 226,087** for financing purposes[145](index=145&type=chunk)[148](index=148&type=chunk) [Board of Directors](index=39&type=section&id=Board%20of%20Directors) As of December 31, 2024, the Board of Directors comprised eight members, led by Chairman William M. Burns, with three standing committees overseeing financial reporting, compensation, and R&D strategy - The Board of Directors consists of **eight members**, with William M. Burns as Chairman. All members except CEO Patrick Amstutz are non-executive[164](index=164&type=chunk)[183](index=183&type=chunk) - The Board has established three committees: Audit and Finance, Nomination and Compensation, and Research and Development[207](index=207&type=chunk) - The Audit and Finance Committee, chaired by Sandip Kapadia, oversees financial reporting, internal controls, and the external auditor[209](index=209&type=chunk)[214](index=214&type=chunk) - The Nomination and Compensation Committee, chaired by William M. Burns, supports the Board in compensation strategy and proposals[216](index=216&type=chunk)[219](index=219&type=chunk) - The Research and Development Committee, chaired by Michael Vasconcelles, provides strategic advice on R&D programs and emerging science[220](index=220&type=chunk)[223](index=223&type=chunk) [Management Board](index=53&type=section&id=Management%20Board) As of December 31, 2024, the Management Board comprised five members, led by CEO Patrick Amstutz, to whom the Board of Directors has delegated executive and operational management - The Management Board consists of **five members**: Patrick Amstutz (CEO), Renate Gloggner (EVP People and Community), Philippe Legenne (CMO), Michael Tobias Stumpp (EVP Projects), and Alexander Zürcher (COO)[228](index=228&type=chunk)[229](index=229&type=chunk) - Executive management is delegated by the Board of Directors to the CEO, who is supported by the Management Board[225](index=225&type=chunk) - All **five members** of the Management Board held employment agreements with an indefinite term and a maximum termination notice period of one year[245](index=245&type=chunk) [Compensation Report](index=61&type=section&id=Compensation%20Report) [Compensation Policy and Governance](index=61&type=section&id=Compensation%20Policy%20and%20Governance) The company's compensation policy aims to attract and retain talent by promoting an entrepreneurial mindset, with governance overseen by the Nomination and Compensation Committee (NCC) and distinct fixed and variable structures for the Board and Management Board - The Nomination and Compensation Committee (NCC) supports the Board of Directors in establishing compensation strategy and guidelines[267](index=267&type=chunk) - Shareholders vote annually on the maximum aggregate compensation for the Board of Directors and the Management Board[279](index=279&type=chunk) - Board of Directors' compensation consists of a fixed cash fee (~**35%**) and Restricted Share Units (RSUs, ~**65%**)[283](index=283&type=chunk)[285](index=285&type=chunk) - Management Board's compensation is split into fixed salary (~**50%**), a short-term cash bonus (~**15%**), and long-term Performance Share Units (PSUs, ~**35%**)[284](index=284&type=chunk)[285](index=285&type=chunk) [Compensation Components](index=67&type=section&id=Compensation%20Components) Compensation components include fixed cash fees and RSUs for the Board, and base salary, variable cash bonuses (target **40-50%** of base), and PSUs with three-year cliff vesting for the Management Board, tied to corporate goals and share price performance - The Management Board's cash bonus is determined by achieving annual corporate goals, with a payout between **0%** and **150%** of the target bonus[293](index=293&type=chunk)[295](index=295&type=chunk) - The 2024 corporate goals were weighted across three categories: strengthening the DARPin portfolio, securing financial runway, and developing the organization[295](index=295&type=chunk)[296](index=296&type=chunk) - Management Board PSUs have a **3-year** cliff-vesting period. The final number of shares (**0-150%** of target) is determined after **12 months** based on corporate goal achievement (**120%** max) and relative share price performance (**30%** max)[302](index=302&type=chunk)[305](index=305&type=chunk)[306](index=306&type=chunk) - As of December 31, 2024, there were no more stock options outstanding from the pre-IPO ESOP plans[313](index=313&type=chunk) [Compensation for Financial Year under Review](index=72&type=section&id=Compensation%20for%20Financial%20Year%20under%20Review) For FY 2024, total compensation for the Board of Directors was **CHF 1.107 million** (**63%** as RSUs), and for the Management Board was **CHF 4.137 million** (**53%** variable), with a **90%** achievement ratio for corporate goals, all within approved budgets Board of Directors Compensation 2024 (in CHF 1,000) | Member | Total Compensation | | :--- | :--- | | William Burns (Chairman) | 302 | | Steven Holtzman | 135 | | Sandip Kapadia | 130 | | Vito J. Palombella | 125 | | Michael Vasconcelles | 135 | | Agnete Fredriksen | 141 | | Dominik Höchli | 139 | | **Total** | **1,107** | Management Board Compensation 2024 (in CHF 1,000) | Member | Total Compensation | | :--- | :--- | | Patrick Amstutz (CEO) | 1,095 | | **Total Management Board** | **4,137** | - The achievement ratio for the 2024 corporate goals was **90%**, which directly impacts the cash bonus payout[326](index=326&type=chunk)[327](index=327&type=chunk) - As of December 31, 2024, the company has not granted any loans, credit lines, or post-retirement benefits beyond standard occupational schemes to board or management members[335](index=335&type=chunk) [Financial Reports](index=82&type=section&id=Financial%20Reports) [IFRS Consolidated Financial Statements](index=82&type=section&id=IFRS%20Consolidated%20Financial%20Statements) The IFRS consolidated financial statements show a net loss of **CHF 54.0 million** for 2024 (improved from **CHF 62.0 million** in 2023), with total assets at **CHF 158.5 million** and a cash runway into 2027, supported by a **$20 million** capital increase Consolidated Statement of Financial Position (in CHF thousands) | | Dec 31, 2024 | Dec 31, 2023 | | :--- | :--- | :--- | | **Total Assets** | **158,528** | **198,352** | | Total current assets | 154,281 | 192,459 | | Total non-current assets | 4,247 | 5,893 | | **Total Shareholders' Equity and Liabilities** | **158,528** | **198,352** | | Total shareholders' equity | 141,637 | 176,429 | | Total liabilities | 16,891 | 21,923 | Consolidated Statement of Profit or Loss (in CHF thousands) | | 2024 | 2023 | | :--- | :--- | :--- | | Total revenues and other income | 4,970 | 7,038 | | Total operating expenses | (66,187) | (68,146) | | Operating result | (61,217) | (61,108) | | Net result, attributable to shareholders | (54,043) | (61,984) | | Basic net result per share (in CHF) | (1.59) | (1.89) | - Revenue of **CHF 5.0 million** in 2024 was recognized from the Novartis Radioligand Agreement, with the full upfront payment now recognized as the collaboration activities ended in Q3 2024[436](index=436&type=chunk) - The company executed a capital increase in October 2024, issuing **3,642,988** new shares and raising gross proceeds of approximately **USD 20 million** (net proceeds after costs: **CHF 15.6 million**)[455](index=455&type=chunk)[361](index=361&type=chunk) [Molecular Partners AG Financial Statements](index=131&type=section&id=Molecular%20Partners%20AG%20Financial%20Statements) The standalone financial statements for Molecular Partners AG report a net loss of **CHF 50.6 million** for 2024 (improved from **CHF 56.3 million** in 2023), with total assets at **CHF 158.3 million**, and a proposed cumulative loss of **CHF 199.4 million** Molecular Partners AG Income Statement (in CHF thousands) | | 2024 | 2023 | | :--- | :--- | :--- | | Total revenues | 4,970 | 7,038 | | Total operating expenses | (62,789) | (62,448) | | Operating result | (57,819) | (55,410) | | **Net result** | **(50,643)** | **(56,285)** | Molecular Partners AG Balance Sheet (in CHF thousands) | | Dec 31, 2024 | Dec 31, 2023 | | :--- | :--- | :--- | | **Total Assets** | **158,309** | **198,248** | | **Total Liabilities and Shareholders' Equity** | **158,309** | **198,248** | | Total liabilities | 12,228 | 17,164 | | Total shareholders' equity | 146,081 | 181,084 | - The Board of Directors proposes to carry forward the net loss of **CHF 50.6 million**, increasing the cumulative loss to **CHF 199.4 million**[644](index=644&type=chunk)[645](index=645&type=chunk)

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]