Molecular Partners AG(MOLN)
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Molecular Partners Announces All Board Proposals Approved at the Annual General Meeting
Newsfilter· 2024-04-17 15:12
ZURICH-SCHLIEREN, Switzerland and CONCORD, Mass., April 17, 2024 (GLOBE NEWSWIRE) -- Molecular Partners AG ((SIX: MOLN, NASDAQ:MOLN), a clinical-stage biotech company developing a new class of custom-built protein drugs known as DARPin therapeutics, today announced that all motions proposed by the Board of Directors at the Annual General meeting were approved by the shareholders of the Company by a wide majority. The Molecular Partners shareholders confirmed the approval of the annual review, the IFRS conso ...
Molecular Partners AG(MOLN) - 2023 Q4 - Annual Report
2024-03-14 20:01
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 20-F (Mark One) ☐ REGISTRATION STATEMENT PURSUANT TO SECTION 12(b) OR (g) OF THE SECURITIES EXCHANGE ACT OF 1934 OR ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to OR ☐ SHELL COMPANY REPORT PURSUANT TO SECTION 13 OR 15(d) OF ...
Molecular Partners AG(MOLN) - 2023 Q2 - Earnings Call Transcript
2023-08-25 19:00
Patrick Amstutz Patrick Amstutz Molecular Partners AG (NASDAQ:MOLN) Q2 2023 Earnings Conference Call August 25, 2023 8:00 AM ET Seth Lewis - SVP, IR Patrick Amstutz - CEO Robert Hendriks - SVP, Finance Daina Graybosch - SVB Leerink LLC Richard Vosser - JPMorgan Michael Nedelcovych - TD Cowen Good day, and welcome to the Molecular Partners First Half 2023 Results Conference Call. [Operator Instructions] Thank you. Seth Lewis, Senior Vice President of Investor Relations you may begin your conference. Thanks R ...
Molecular Partners AG(MOLN) - 2023 Q1 - Quarterly Report
2023-05-12 10:05
Exhibit 99.1 Condensed consolidated interim financial statements (unaudited) | | | March 31, | December | | --- | --- | --- | --- | | Condensed consolidated interim statement of financial position as of | | 2023 | 31, 2022 | | in CHF thousands | Note | | | | Assets | | | | | Property, plant and equipment | | 6,768 | 7,235 | | Intangible assets | | 287 | 271 | | Total non-current assets | | 7,055 | 7,506 | | Short-term time deposits | | 158,442 | 161,198 | | Other current assets | | 3,363 | 4,589 | | Trade a ...
Molecular Partners AG(MOLN) - 2022 Q4 - Earnings Call Transcript
2023-03-10 18:05
Financial Data and Key Metrics Changes - The company reported revenue of approximately CHF 190 million for 2022, primarily driven by collaborations with Novartis, with CHF 173 million attributed to this partnership [70][59] - Operating expenses were reported at CHF 73 million, aligning with previous guidance of 70% to 75% [59] - The company ended the year with a cash balance of nearly CHF 250 million, which is expected to sustain operations into 2026 [18][36] Business Line Data and Key Metrics Changes - The company is focusing on its tri-specific T-cell engager, 533, in acute myeloid leukemia (AML), with initial patient dosing completed and ongoing preclinical data supporting its efficacy [67][60] - The local CD40 agonist, MPO317, has successfully reached the highest dose in its trial without dose-limiting toxicities, indicating a promising mode of action [60][67] Market Data and Key Metrics Changes - The company is exploring partnerships for its Radio DARPin therapy platform, which aims to expand the ligand space and target a broader range of tumors [16][20] - The collaboration with Novartis includes two exclusive targets, with potential for additional partnerships to enhance access to radioisotopes [16][20] Company Strategy and Development Direction - The company emphasizes differentiation through its DARPin technology, aiming to address unmet medical needs and generate early clinical readouts [55][14] - The strategy includes potential partnerships to advance products that may not be best developed in-house, focusing on generating patient value [55][20] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's financial position, highlighting the ability to fund operations through 2026 without relying on immediate partnerships [10][36] - The company is optimistic about the potential of its pipeline, particularly the 533 program, and aims to provide initial safety and efficacy results in the second half of the year [60][38] Other Important Information - The company is committed to corporate sustainability and ESG principles, integrating these values into its culture and operations [35][17] - The company is actively working on reducing kidney uptake in its therapies, which is a common challenge for protein-based treatments [4][6] Q&A Session Summary Question: What are the plans for expanding clinical sites for 533? - The initial trials for 533 are planned in Europe, with intentions to expand to the U.S. contingent on positive results [29][25] Question: What is the status of the Novartis collaboration regarding kidney accumulation issues? - The company clarified that kidney accumulation is a systemic issue for protein therapeutics and is not a rate-limiting factor for the collaboration with Novartis [23][22] Question: What are the potential partnerships for the MPO317 program? - Likely partners include companies in immuno-oncology that have a vested interest in CD40 and FAP combinations, especially in light of competitive data from Roche [82][81]
Molecular Partners AG(MOLN) - 2022 Q4 - Annual Report
2023-03-09 21:01
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 20-F (Mark One) ☐ REGISTRATION STATEMENT PURSUANT TO SECTION 12(b) OR (g) OF THE SECURITIES EXCHANGE ACT OF 1934 OR ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2022 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to OR ☐ SHELL COMPANY REPORT PURSUANT TO SECTION 13 OR 15(d) OF ...
Molecular Partners AG(MOLN) - 2022 Q4 - Annual Report
2023-03-09 21:00
[Executive Summary](index=1&type=section&id=Executive%20Summary) Molecular Partners highlights 2022 achievements, including clinical advancements and a strong financial position with cash runway into 2026 [Overall Highlights and Outlook](index=1&type=section&id=Overall%20Highlights%20and%20Outlook) Molecular Partners highlights 2022 achievements, including MP0533 Phase 1, Radio DARPin Platform progress, and a strong financial position with cash into 2026 - Initiated Phase 1 study of MP0533, a novel tri-specific T-cell engager for the treatment of acute myeloid leukemia (AML) and high risk myelodysplastic syndrome (MDS)[5](index=5&type=chunk) - Established Radio DARPin Therapy (RDT) Platform, formally selecting tumor-associated protein Delta-like ligand 3 (DLL3) as a first target[5](index=5&type=chunk) - Signed a non-binding letter of intent with Novartis in early January 2023 to negotiate a Research Framework Agreement focused on emerging infectious global health threats[5](index=5&type=chunk) - **Net cash inflow from operating activities of CHF 118.6 million** in 2022[5](index=5&type=chunk) - Ongoing strong financial position with **CHF 249.1 million in cash and short-term deposits** as of December 31, 2022, anticipated to support operations into **2026**[5](index=5&type=chunk) - Full year 2023 operating expense guidance of **CHF 70-80 million**, reflecting ambition to further broaden the pipeline in oncology and virology[5](index=5&type=chunk) [Research & Development Highlights](index=1&type=section&id=Research%20%26%20Development%20Highlights) Molecular Partners advanced its oncology and Radio DARPin platforms, halted ensovibep, and regained abicipar rights, pursuing new infectious disease collaborations [Oncology](index=2&type=section&id=Oncology) Oncology pipeline advanced with MP0317 showing tumor-localized CD40 activation and MP0533 initiating Phase 1 for AML/MDS [MP0317](index=2&type=section&id=MP0317) MP0317 Phase 1 interim results showed tumor-localized CD40 activation, good tolerability, with dose escalation recruitment completing H1 2023 - Presented interim results from ongoing Phase 1 trial of MP0317 in November 2022, demonstrating first clinical observation of **tumor-localized CD40 activation**[7](index=7&type=chunk) - MP0317 was **safe and well tolerated** with no dose-limiting CD40-related systemic toxicities[7](index=7&type=chunk) - Patient recruitment in the dose escalation portion of the Phase 1 trial is expected to be completed in the **first half of 2023**[7](index=7&type=chunk) [MP0533](index=2&type=section&id=MP0533) MP0533 Phase 1 study for AML/MDS initiated in January 2023, with preclinical data showing preferential cancer cell killing - First patient dosed in Phase 1 study of MP0533 in January 2023; initial clinical results expected by **Q4 2023**[8](index=8&type=chunk) - Preclinical results showed MP0533 can induce **preferential killing of cells** expressing two or three tumor-associated antigens (TAAs) compared to cells expressing a single TAA, reducing damage to healthy cells[8](index=8&type=chunk) - MP0533 was demonstrated to activate T-cells and destroy AML cells, including leukemic stem cells (LSCs), while sparing hematopoietic stem cells[8](index=8&type=chunk) [Radio DARPin Therapy Platform](index=2&type=section&id=Radio%20DARPin%20Therapy%20Platform) Radio DARPin Therapy Platform advanced by reducing kidney uptake, with DLL3 selected as the first therapeutic target - Progressed Radio DARPin Therapy Platform by reducing kidney uptake of DARPin radio conjugates to overcome nephrotoxicity[9](index=9&type=chunk) - Selected tumor-associated protein Delta-like ligand 3 (DLL3) as the first target of a DARPin-based therapeutic candidate[9](index=9&type=chunk) [Virology](index=2&type=section&id=Virology) Ensovibep clinical development halted due to lack of efficacy, but a new research agreement with Novartis for infectious threats was signed - Clinical development of ensovibep was halted in 2022 due to a lack of neutralization activity against omicron subvariants[11](index=11&type=chunk) - Novartis submitted a request to withdraw ensovibep's EUA from the FDA, effective **January 25, 2023**[12](index=12&type=chunk) - Signed a non-binding letter of intent with Novartis in January 2023 to negotiate a Research Framework Agreement focused on pandemic preparedness and fighting emerging infectious global health threats[12](index=12&type=chunk) [Ophthalmology](index=3&type=section&id=Ophthalmology) Molecular Partners regained abicipar rights for nAMD and DME after positive Phase 3 studies and is evaluating business opportunities - Regained global development and commercial rights to abicipar for nAMD and DME in **November 2021**[13](index=13&type=chunk) - Abicipar completed two positive Phase 3 studies (CEDAR and SEQUOIA) supporting the non-inferior efficacy of its quarterly dosing regimen[13](index=13&type=chunk) [Corporate Governance and ESG](index=3&type=section&id=Corporate%20Governance%20and%20ESG) Molecular Partners implemented leadership changes and advanced ESG initiatives, establishing Board-level oversight and promoting diversity and inclusion [Leadership Changes](index=3&type=section&id=Leadership%20Changes) Molecular Partners announced leadership changes, including CEO's new board role, key promotions, a new General Counsel, and CFO's departure - CEO Patrick Amstutz was elected as President of the Swiss Biotech Association Board of Directors, effective **May 3, 2022**[15](index=15&type=chunk) - Alexander Zürcher was promoted to Chief Operating Officer, and Renate Gloggner to EVP People and Community, both effective **July 1, 2022**[16](index=16&type=chunk) - Michael Pitzner was appointed General Counsel and Senior Vice President of Legal, effective **November 1, 2022**[17](index=17&type=chunk) - CFO Andreas Emmenegger departed the company as of **December 31, 2022**, after more than 15 years[19](index=19&type=chunk) [ESG Initiatives](index=3&type=section&id=ESG%20Initiatives) Molecular Partners published 2022 ESG priorities, established Board-level oversight, and created an ESG Circle to integrate sustainability and DEI - Published environmental, social and governance (ESG) priorities and progress in **2022**[20](index=20&type=chunk) - Formally established corporate sustainability responsibility at a Board level, with the Finance and Audit Committee leading oversight of all ESG policies[21](index=21&type=chunk) - Created an ESG Circle of key internal stakeholders to ensure continued progress across key priorities, including human capital management and Diversity, Equity and Inclusion (DEI)[21](index=21&type=chunk)[22](index=22&type=chunk) [Financial Performance and Outlook](index=1&type=section&id=Financial%20Performance%20and%20Outlook) Molecular Partners reported a **CHF 117.8 million net profit** in 2022, projecting **CHF 70-80 million** operating expenses for 2023 with cash into 2026 [Full Year 2022 Financial Highlights](index=4&type=section&id=Full%20Year%202022%20Financial%20Highlights) Molecular Partners achieved a **CHF 117.8 million net profit** in 2022, driven by increased revenues, maintaining a strong cash position and debt-free balance sheet Key Financials (CHF million, except per share, FTE data) | Key Financials (CHF million, except per share, FTE data) | FY 2022 | FY 2021 | Change | | :--- | :--- | :--- | :--- | | Total revenues and other income | 189.6 | 9.8 | 179.8 | | R&D expenses | (50.7) | (55.7) | 5.0 | | SG&A expenses | (22.3) | (17.5) | (4.8) | | Operating result | 116.6 | (63.4) | 180.0 | | Net finance result | 1.2 | (0.4) | 1.6 | | Net result | 117.8 | (63.8) | 181.6 | | Basic net result per share (in CHF) | 3.63 | (2.06) | 5.69 | | Diluted net result per share (in CHF) | 3.54 | (2.06) | 5.60 | | Net cash from (used in) operating activities | 118.6 | (91.0) | 209.5 | | Cash & cash equivalents (incl. short-term time deposits) | 249.1 | 132.8 | 116.3 | | Total shareholders' equity | 235.2 | 107.3 | 127.9 | | Number of total FTE | 175.3 | 163.2 | 12.1 | - Total revenues and other income increased significantly to **CHF 189.6 million** in 2022 (from CHF 9.8 million in 2021), leading to an operating profit of **CHF 116.6 million** (vs. operating loss of CHF 63.4 million in 2021)[23](index=23&type=chunk) - Net profit for 2022 was **CHF 117.8 million** (vs. net loss of CHF 63.8 million in 2021)[23](index=23&type=chunk) - Net cash from operating activities was **CHF 118.6 million** in 2022 (vs. net cash used of CHF 91.0 million in 2021)[24](index=24&type=chunk) - Cash and short-term deposits stood at **CHF 249.1 million** as of December 31, 2022, an increase of **CHF 116.3 million** from year-end 2021[24](index=24&type=chunk) - The Company's balance sheet continued to be **debt-free** in 2022, and FTEs increased by **7%** year-on-year to **175.3**[25](index=25&type=chunk) [2023 Business and Financial Outlook](index=4&type=section&id=2023%20Business%20and%20Financial%20Outlook) Molecular Partners plans continued investment in clinical assets, with MP0533 results in Q4 2023, and projects **CHF 70-80 million** operating expenses with cash into 2026 - Anticipates initial clinical results of the Phase 1 trial for MP0533 in AML in **Q4 2023**[5](index=5&type=chunk)[28](index=28&type=chunk) - Expects completion of patient recruitment in the dose escalation of MP0317 Phase 1 trial in **H1 2023**[5](index=5&type=chunk)[28](index=28&type=chunk) - Full year 2023 operating expenses are expected to be **CHF 70-80 million** (at constant exchange rates)[5](index=5&type=chunk)[30](index=30&type=chunk) - Based on the cash position as of December 31, 2022, the cash runway is expected to reach into **2026**, excluding any potential receipts from R&D partners[5](index=5&type=chunk)[25](index=25&type=chunk)[30](index=30&type=chunk) [Company Information and Disclosures](index=5&type=section&id=Company%20Information%20and%20Disclosures) This section provides details on company reports, upcoming events, an overview of Molecular Partners AG, forward-looking statement disclaimers, and contact information [Documentation & Events](index=5&type=section&id=Documentation%20%26%20Events) Molecular Partners' 2022 annual reports will be available online, with a conference call on March 10, 2023, and a financial calendar for 2023 events - The Company's Annual Report on Form 20-F for the year ended December 31, 2022, and the annual report 2022 will be made available on www.molecularpartners.com after **March 9, 2023**[31](index=31&type=chunk) - A conference call and audio webcast for the full year 2022 results will be held on **March 10, 14.00 CET (8.00 am EST)**[32](index=32&type=chunk) Financial Calendar 2023 | Date | Event | | :--- | :--- | | April 4, 2023 | Annual General Meeting | | May 11, 2023 | Interim Management Statement Q1 2023 | | August 24, 2023 | Half-year results 2023 (unaudited) | | October 26, 2023 | Interim Management Statement Q3 2023 | [About Molecular Partners AG](index=5&type=section&id=About%20Molecular%20Partners%20AG) Molecular Partners AG is a clinical-stage biotech company developing DARPin therapeutics, partnering with pharmaceutical companies across multiple therapeutic areas - Molecular Partners AG is a clinical-stage biotech company developing DARPin therapeutics, a new class of custom-built protein drugs[35](index=35&type=chunk) - The Company has formed partnerships with leading pharmaceutical companies to advance DARPin therapeutics in ophthalmology, oncology, and infectious disease[35](index=35&type=chunk) [Forward-Looking Statements](index=5&type=section&id=Forward-Looking%20Statements) This section cautions that forward-looking statements involve risks and uncertainties that could cause actual results to differ materially - Any statements in this press release that do not describe historical facts may constitute forward-looking statements[36](index=36&type=chunk) - These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected[37](index=37&type=chunk) - Key factors include plans to develop and commercialize product candidates, reliance on third-party partners, ongoing clinical trials, regulatory approvals, and the potential impact of the COVID-19 pandemic[37](index=37&type=chunk) [Contact Information](index=6&type=section&id=Contact%20Information) Contact details for investor relations and communications are provided for inquiries - Investor Relations contact: Seth Lewis, seth.lewis@molecularpartners.com, Tel: **+1 781 420 2361**[38](index=38&type=chunk) - Communications contact: Antonio Ligi, antonio.ligi@molecularpartners.com, Tel: **+41 79 723 36 81**[38](index=38&type=chunk)
Molecular Partners AG(MOLN) - 2022 Q2 - Earnings Call Transcript
2022-08-26 16:58
Financial Data and Key Metrics Changes - The company reported CHF 184.5 million in revenue for the first half of 2022, significantly higher than the previous year, primarily due to a CHF 150 million milestone payment from Novartis for the Ensovibep option [43][46] - Operating profit reached CHF 146.3 million, compared to an operating loss of CHF 34.8 million in the same period last year [47] - Net profit for the first half of 2022 was CHF 148.6 million, a substantial increase from a loss in the previous year [48] Business Line Data and Key Metrics Changes - The revenue from Novartis accounted for CHF 168 million of the total revenue, with the remainder coming from other collaborations [46] - Total operating expenses were CHF 38.3 million, slightly lower than the previous year, with personnel costs at CHF 20.5 million and external R&D at CHF 9.5 million [47] Market Data and Key Metrics Changes - The company has a strong cash position of CHF 285 million, providing a runway into 2026, which is a significant advantage in the current biotech environment [42][16] - The company is not currently paying taxes due to carried forward losses, which amounted to CHF 212 million last year [48] Company Strategy and Development Direction - The company aims to focus on early clinical readouts that provide true patient value, particularly in oncology and infectious diseases [17][18] - The strategy includes leveraging DARPins for unique solutions in drug development, avoiding me-too products [19] - The company is committed to partnerships and collaborations to advance its programs, which is a core aspect of its operational philosophy [20] Management's Comments on Operating Environment and Future Outlook - Management acknowledged the challenges posed by the global biotech crisis but emphasized the company's strong cash position and pipeline as key strengths [10][16] - The company is optimistic about its future, with several programs expected to reach candidate stage in the coming year [66] - Management highlighted the importance of maintaining flexibility in trial designs and partnerships to adapt to the evolving market conditions [92][94] Other Important Information - The company has issued 3.5 million treasury shares as part of a shelf filing, which is a customary practice for U.S. listed companies [45] - The company is exploring the potential for its drug candidates in various markets, including the possibility of addressing local surges in COVID-19 cases outside the U.S. [112] Q&A Session Summary Question: What should investors expect from the data disclosure for 317 later this year? - Management indicated that most data will be shared with potential partners rather than publicly, focusing on demonstrating drug activity and safety [72][74] Question: What is the expected percentage of AML blasts expressing at least two markers in the Phase 1 trial for 533? - Management stated that the co-expression percentage is above 90%, and they expect to see single-agent activity [76][78] Question: What is the timeline for Novartis to start the Phase 3 trial for Ensovibep? - Management noted that the timeline is uncertain due to changing endpoints and the need for agreement on trial design [90][92] Question: Can you elaborate on the causes of inflammation in Abicipar and the processes to remove it? - Management explained that the inflammation was caused by a contaminant in the syringe, which can be addressed by using non-silicon oil syringes [96][98]
Molecular Partners AG(MOLN) - 2022 Q2 - Earnings Call Presentation
2022-08-26 11:46
| --- | --- | --- | --- | |---------------------------------------------------------------|-------|-------|-------| | | | | | | | | | | | | | | | | H1 2022 Corporate Highlights and Financials | | | | | August 26 , 2022 | | | | | Molecular Partners AG, Switzerland (SIX: MOLN, NASDAQ: MOLN) | | | | 1 Disclaimer This presentation contains forward looking statements. Any statements contained in this presentation that do not describe historical facts may constitute forward-looking statements as that term is defi ...
Molecular Partners AG(MOLN) - 2021 Q4 - Earnings Call Transcript
2022-03-16 20:53
Molecular Partners AG (NASDAQ:MOLN) Q4 2021 Earnings Conference Call March 16, 2022 8:00 AM ET Company Participants Seth Lewis - Head, Investor Relations Patrick Amstutz - Chief Executive Officer Andreas Emmenegger - Chief Financial Officer Conference Call Participants Richard Vosser - JPMorgan Georgi Yordanov - Cowen & Company Jo Walton - Credit Suisse Daina Graybosch - SVB Leerink Operator Good morning and thank you for standing by. Welcome to the Publication of Full Year Results 2021. [Operator Instructi ...