[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]

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]

Core Insights - Molecular Partners AG and Orano Med have expanded their strategic collaboration to develop a total of ten targeted alpha therapeutics candidates, enhancing their leadership in the field of targeted alpha therapies (TAT) [1][2][9] Collaboration Details - The new agreement includes the development of six additional targeted alpha therapeutics candidates, with Molecular Partners leading the development and Orano Med having the option to co-develop two of these programs [2][3] - The initial agreement in January 2024 involved co-developing four programs, with shared costs and profits, and specific commercialization rights assigned to each company for different programs [3] Technological Synergy - The partnership leverages Molecular Partners' Radio-DARPin platform and Orano Med's expertise in lead-212 (Pb) supply and clinical development, aiming to reduce drug candidate cycle times and enhance the generation of novel drug candidates [4][6] - The collaboration is expected to accelerate the delivery of next-generation targeted alpha therapies to patients, showcasing the strategic synergies between the two companies [6] Financial Outlook - Financial terms of the expanded agreement have not been disclosed, but Molecular Partners anticipates no immediate impact on its financial forecast for fiscal year 2025 and maintains its funding guidance through 2027 [7] Product Development - The most advanced Pb-Radio-DARPin candidate, MP0712, which targets DLL3, is expected to enter first-in-human studies in 2025, pending regulatory approval [3][9] - The Radio-DARPin platform is designed to provide a unique delivery system for radioactive payloads, enhancing targeting capabilities while balancing safety and efficacy [11]

Core Insights - Molecular Partners AG is a clinical-stage biotech company focused on developing DARPin therapeutics, which are custom-built protein drugs designed to address medical challenges that other drug modalities cannot effectively tackle [5] Group 1: Upcoming Conferences - The company will present its latest developments and outlook for 2025 at two investor conferences in January [1] - The first conference is the Baader Helvea Swiss Equities Conference, scheduled for January 8-10 in Bad Ragaz, Switzerland, where COO Alexander Zürcher will present on January 8 [2] - The second conference is the 43rd Annual JP Morgan Healthcare Conference, taking place from January 13-16 in San Francisco, CA, where CEO Patrick Amstutz will present on January 15 at 9:00 am PT [3] Group 2: Company Overview - Molecular Partners AG was founded in 2004 and has offices in Zurich, Switzerland, and Concord, Massachusetts, USA [5] - The company specializes in oncology and has various programs in different stages of pre-clinical and clinical development [5] - Molecular Partners leverages the advantages of DARPins to provide unique solutions through proprietary programs and partnerships with leading pharmaceutical companies [5]

Summary of Key Points Core Viewpoint - Molecular Partners AG (MOLN) has seen a 5.7% increase in share price over the past four weeks, closing at $5.55, with a potential upside of 80.7% based on Wall Street analysts' mean price target of $10.03 [1]. Price Targets and Analyst Consensus - The average price target for MOLN ranges from a low of $5.10 to a high of $15, with a standard deviation of $4.95, indicating variability in analyst estimates [2]. - The lowest estimate suggests an 8.1% decline from the current price, while the highest indicates a 170.3% upside [2]. - A low standard deviation signifies strong agreement among analysts regarding the stock's price movement direction [7]. Earnings Estimates and Market Sentiment - Analysts have shown increasing optimism about MOLN's earnings prospects, as evidenced by upward revisions in EPS estimates [9]. - Over the last 30 days, the Zacks Consensus Estimate for the current year has increased by 2.2%, with one estimate moving higher and no negative revisions [10]. - MOLN holds a Zacks Rank 2 (Buy), placing it in the top 20% of over 4,000 ranked stocks based on earnings estimate factors, indicating strong potential for upside [11]. Caution on Price Targets - Solely relying on consensus price targets for investment decisions may not be prudent, as analysts' ability to set unbiased targets has been questioned [3][5]. - Analysts often set optimistic price targets due to business incentives, which can lead to inflated estimates [6]. - While price targets should not be ignored, they should be approached with skepticism, as they may not accurately predict stock price movements [8].

Core Insights - The article discusses the preclinical proof-of-concept data for MP0621, a multispecific cKit x CD16a x CD47 Switch-DARPin program developed by Molecular Partners AG, which shows potential for treating acute myeloid leukemia (AML) and enhancing hematopoietic stem cell transplantation (HSCT) outcomes [8][9][10] Group 1: Product Development - MP0621 is designed to selectively kill cKit-positive cells while conditionally blocking CD47, aiming to reduce toxicity associated with current high-intensity conditioning regimens [2][11] - The Switch-DARPin platform allows for logic-gated activation, meaning MP0621 binds to cKit and subsequently unblocks the anti-CD47 component, enhancing the therapeutic effect without harming healthy cells [10][11] - Preclinical studies indicate that MP0621 can deplete cKit+ cells in the bone marrow of humanized mice without affecting circulating immune cells, suggesting a favorable pharmacokinetic profile for HSCT therapy in humans [11] Group 2: Clinical Implications - The development of MP0621 aims to improve HSCT outcomes for AML patients, particularly those with poor cytogenetic risk profiles, by maximizing the therapeutic potential of HSCT and extending access to potentially curative treatments [9] - The conditional blockade of CD47 enhances the efficacy of cKit targeting, achieving phagocytosis levels comparable to a combination of anti-cKit and anti-CD47 monoclonal antibodies [11] - MP0621 is currently in IND-enabling studies, with Phase 1 trials anticipated to begin in 2025 [1][8]

MP0712, a 212Pb-Radio-DARPin targeting DLL3, as first candidate of Molecular Partners' RDT platform in development in partnership with Orano Med Positive tumor to kidney ratio and biodistribution, favorable antitumor activity and safety profile First-in-human study in planning with initial data expected in 2025 RDT platform expanding with portfolio of additional targets under evaluation About Orano Med SAS "Three years ago, we started our venture into the radiotherapy space. We have made tremendous progress ...