Molecular Partners Reports Financial Results and Highlights from Q1 2025
Molecular Partners (NASDAQ: MOLN) reported Q1 2025 financial results and key milestones. The company maintains a strong cash position of CHF 131 million as of March 31, 2025, providing funding into 2027. Two significant developments include:
1. The expansion of their partnership with Orano Med from 4 to 10 programs for Radio-DARPin therapies, with MP0712 progressing toward IND filing and initial clinical data expected in 2025.
2. Positive progress in the MP0533 Phase 1/2a trial, with cohort 8 showing increased response rates and depth in AML treatment. The study protocol has been amended and cohort 9 enrollment has begun.
The company expects total operating expenses of CHF 55-65 million for 2025, with approximately CHF 7 million in non-cash costs.
Molecular Partners (NASDAQ: MOLN) ha comunicato i risultati finanziari del primo trimestre 2025 e i principali traguardi raggiunti. L'azienda mantiene una solida posizione di cassa di 131 milioni di CHF al 31 marzo 2025, garantendo finanziamenti fino al 2027. Due sviluppi significativi includono:
1. L'espansione della collaborazione con Orano Med da 4 a 10 programmi per terapie Radio-DARPin, con MP0712 che avanza verso la presentazione dell'IND e i primi dati clinici attesi nel 2025.
2. Progressi positivi nello studio di fase 1/2a di MP0533, con la coorte 8 che mostra un aumento del tasso di risposta e della profondità nel trattamento della leucemia mieloide acuta (AML). Il protocollo dello studio è stato modificato e l'arruolamento della coorte 9 è iniziato.
L'azienda prevede spese operative totali tra 55 e 65 milioni di CHF per il 2025, con circa 7 milioni di CHF di costi non monetari.
Molecular Partners (NASDAQ: MOLN) informó los resultados financieros del primer trimestre de 2025 y los principales hitos alcanzados. La compañía mantiene una sólida posición de efectivo de 131 millones de CHF al 31 de marzo de 2025, asegurando financiamiento hasta 2027. Dos desarrollos importantes incluyen:
1. La expansión de su alianza con Orano Med de 4 a 10 programas para terapias Radio-DARPin, con MP0712 avanzando hacia la presentación del IND y los primeros datos clínicos esperados en 2025.
2. Progresos positivos en el ensayo de fase 1/2a de MP0533, con la cohorte 8 mostrando tasas de respuesta y profundidad aumentadas en el tratamiento de la leucemia mieloide aguda (AML). El protocolo del estudio ha sido modificado y ha comenzado la inscripción de la cohorte 9.
La compañía espera gastos operativos totales de entre 55 y 65 millones de CHF para 2025, con aproximadamente 7 millones de CHF en costos no monetarios.
Molecular Partners (NASDAQ: MOLN)은 2025년 1분기 재무 실적과 주요 이정표를 발표했습니다. 회사는 2025년 3월 31일 기준으로 1억 3,100만 스위스 프랑(CHF)의 강력한 현금 보유고를 유지하고 있으며, 2027년까지 자금을 확보하고 있습니다. 두 가지 주요 발전 사항은 다음과 같습니다:
1. Orano Med와의 파트너십을 4개 프로그램에서 10개 프로그램으로 확장하여 Radio-DARPin 치료제를 개발 중이며, MP0712는 IND 제출을 향해 진행 중이고 2025년에 초기 임상 데이터가 예상됩니다.
2. MP0533 1/2a상 시험에서 긍정적인 진전이 있었으며, 8번째 코호트는 급성 골수성 백혈병(AML) 치료에서 반응률과 반응 깊이가 증가했습니다. 연구 프로토콜이 수정되었고 9번째 코호트 등록이 시작되었습니다.
회사는 2025년 총 영업비용을 5,500만에서 6,500만 스위스 프랑(CHF)으로 예상하며, 약 700만 CHF의 비현금성 비용이 포함됩니다.
Molecular Partners (NASDAQ : MOLN) a publié ses résultats financiers du premier trimestre 2025 ainsi que ses jalons clés. La société dispose d'une solide trésorerie de 131 millions de CHF au 31 mars 2025, assurant un financement jusqu'en 2027. Deux développements majeurs incluent :
1. L'expansion de leur partenariat avec Orano Med, passant de 4 à 10 programmes pour les thérapies Radio-DARPin, avec MP0712 progressant vers le dépôt de l'IND et les premières données cliniques attendues en 2025.
2. Des progrès positifs dans l'essai de phase 1/2a de MP0533, la cohorte 8 montrant des taux de réponse et une profondeur accrues dans le traitement de la leucémie myéloïde aiguë (LMA). Le protocole de l'étude a été modifié et le recrutement de la cohorte 9 a commencé.
La société prévoit des dépenses opérationnelles totales comprises entre 55 et 65 millions de CHF pour 2025, avec environ 7 millions de CHF de coûts non monétaires.
Molecular Partners (NASDAQ: MOLN) berichtete über die Finanzergebnisse des ersten Quartals 2025 und wichtige Meilensteine. Das Unternehmen verfügt zum 31. März 2025 über eine starke Barreserve von 131 Millionen CHF, die die Finanzierung bis 2027 sichert. Zwei bedeutende Entwicklungen sind:
1. Die Erweiterung der Partnerschaft mit Orano Med von 4 auf 10 Programme für Radio-DARPin-Therapien, wobei MP0712 auf die IND-Einreichung zusteuert und erste klinische Daten im Jahr 2025 erwartet werden.
2. Positive Fortschritte in der Phase-1/2a-Studie von MP0533, wobei Kohorte 8 erhöhte Ansprechraten und -tiefe bei der Behandlung von AML zeigt. Das Studienprotokoll wurde angepasst und die Einschreibung für Kohorte 9 hat begonnen.
Das Unternehmen erwartet für 2025 Gesamtbetriebsausgaben von 55 bis 65 Millionen CHF, davon rund 7 Millionen CHF nicht zahlungswirksame Kosten.
- Strong cash position of CHF 131 million, providing funding well into 2027
- Expansion of Orano Med partnership from 4 to 10 radiotherapy programs
- MP0533 showing improved response rates in cohort 8 with three out of eight evaluable patients demonstrating responses
- MP0712 IND-enabling package completed with favorable preclinical data showing high tumor uptake
- MP0533 earlier cohorts (1-7) showed unsustained responses despite initial activity
- Protocol amendment needed for MP0533 to address exposure profile issues
Insights
MOLN is showing clinical progress on multiple fronts with strong cash runway, solidifying its DARPin platform's potential in oncology.
Molecular Partners' Q1 2025 update reveals significant advancement across their DARPin pipeline, with two key clinical catalysts expected later this year. The company has CHF 131 million in cash as of March 31, 2025, providing runway well into 2027 - representing approximately two years of operational funding based on their projected burn rate of CHF 55-65 million for 2025.
Their Radio-DARPin program MP0712, targeting DLL3 for small cell lung cancer, has completed its IND-enabling package and is poised for a mid-2025 IND filing. Notably, the FDA has allowed them to bypass a previously planned Phase 0 imaging study, accelerating the timeline to Phase 1 dose-escalation trials expected in H2 2025. The company has also secured a compassionate use arrangement in South Africa that will generate first-in-human imaging data, potentially providing earlier proof-of-concept than anticipated.
The strategic partnership with Orano Med has been expanded from four to ten programs, significantly increasing the company's radiotherapy pipeline potential. This expansion demonstrates external validation of their DARPin platform in the rapidly growing radiopharmaceutical space.
For MP0533, their multispecific T-cell engager for AML, data from cohort 8 shows improved response rates with three of eight evaluable patients demonstrating responses following optimization of the dosing regimen. The regulatory approval of their protocol amendment in April 2025 has enabled initiation of cohort 9 with further dosing densification, potentially addressing the prior challenge of unsustained responses.
The preclinical progress on their Switch-DARPin platform shows promising tumor-specific T-cell activation technology that could differentiate their approach in solid tumors. While the company is prioritizing oncology applications, they're seeking partners for their MP0621 program for stem cell transplantation, indicating strategic portfolio focus.
The balance of multiple clinical-stage programs, external partnership validation, and solid cash position positions Molecular Partners favorably as they approach critical data readouts that could validate their novel therapeutic approach.
- Clinical programs on track, with two major milestones later this year, and cash position, CHF 131 million as of March 31, 2025, expected to provide funding well into 2027
- IND filing and initial clinical data on first targeted Radio-DARPin therapy program, MP0712, expected in 2025; strategic partnership with Orano Med expanded from four to ten programs
- Data from dosing cohort 8 in Phase 1/2a trial of MP0533 demonstrate increased rates and depth of responses; study protocol amendment now approved, and dosing cohort 9 enrollment initiated, additional data expected in 2025
ZURICH-SCHLIEREN, Switzerland and CONCORD, Mass., May 15, 2025 (GLOBE NEWSWIRE) -- Ad hoc announcement pursuant to Art. 53 LR – 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 (“Molecular Partners” or the “Company”), today announced corporate highlights and unaudited financial results for the first quarter of 2025.
"Molecular Partners is on track to reach key clinical milestones in 2025. In January, we expanded our strategic radiotherapy partnership with Orano Med and are continuing to advance the lead program, MP0712, towards a first-in-human trial. With the data package of MP0712 complete, we anticipate both the IND filing and initial clinical data on MP0712 in 2025. The early images and dosimetry data will be a strong surrogate for the expected efficacy and safety in Phase 1. Our multispecific T cell engager MP0533 is progressing in its Phase 1/2a trial in acute myeloid leukemia. Initial data from cohort 8, with an additional dosing point in the step-up dosing, indicate increased rates and depth of responses, while the fully amended dosing scheme is being tested in cohort 9. Our focus remains firmly on delivering results that further validate our science and create meaningful value for patients and stakeholders alike, based on a solid financial position with funding in place well into 2027,” said Patrick Amstutz, Ph.D., CEO of Molecular Partners.
Research & Development Highlights
MP0712, Radio-DARPin Pipeline and Global Partnership with Orano Med
In January 2025, Molecular Partners and Orano Med further expanded their agreement to co-develop up to ten 212Pb-labeled radiotherapy programs. Molecular Partners holds commercialization rights to MP0712, a Radio-DARPin therapy (RDT) candidate targeting delta-like ligand 3 (DLL3) for the treatment of small cell lung cancer (SCLC), and to the second program, targeting mesothelin (MSLN). In addition to its world class expertise and capabilities in the development of targeted alpha therapy (TAT) with 212Pb, Orano Med will ensure the production of the 212Pb-based Radio-DARPins for clinical trials and commercialization.
Molecular Partners presented preclinical data in April at the American Association for Cancer Research (AACR) Annual Meeting 2025, showing high tumor uptake and a favorable toxicity profile for MP0712, with good efficacy and tumor reduction in mouse models matching clinically relevant DLL3 expression levels. With these data, the Investigational New Drug (IND)-enabling package is complete.
The IND application for MP0712 is planned for mid 2025 and dialogue with the U.S. Food and Drug Administration (FDA) is ongoing. Based upon discussion with the agency the Company has determined that a Phase 0 imaging study, which was previously planned, will not be necessary. MP0712 will proceed directly to a Phase 1 dose-escalation study utilizing 212Pb, which includes an imaging step using 203Pb. This study will initiate in the second half of 2025, pending IND submission and clearance.
In addition, Molecular Partners has received and accepted a request from Nuclear Medicine Research Infrastructure (NuMeRI) in South Africa to provide MP0712 for imaging use under the legal framework in South Africa for compassionate care (also referred to as Section 21 of the Medicines and Related Substances Act). This approach enables the generation of first images applying MP0712 labelled with 203Pb in patients with SCLC. While the decision of where and how to share data from the image work under Section 21 remains at the discretion of NuMeRI, the Company anticipates providing an update on MP0712 in H2 2025.
The second RDT program co-developed with Orano Med targets MSLN, a tumor target overexpressed across several cancers with high unmet need, such as ovarian cancer. The development of therapeutics against MSLN has been hampered by high shedding of MSLN, leading to high levels of soluble MSLN. Leveraging the unique properties of DARPins, Molecular Partners has developed Radio-DARPins able to selectively bind to membrane-bound MSLN without being impacted by shed MSLN. First preclinical data from the MSLN program were presented at AACR 2025, with in vivo results showing a favorable biodistribution with strong tumor accumulation of the Radio-DARPin in a MSLN-overexpressing model in mice. Molecular Partners will present more preclinical data on the MSLN program in an oral presentation at the 2025 Society of Nuclear Medicine and Molecular Imaging (SNMMI) Annual Meeting in June.
MP0533 (Multispecific T Cell Engager)
MP0533 is currently being evaluated in a Phase 1/2a clinical trial for relapsed/refractory acute myeloid leukemia (AML) and myelodysplastic syndrome/AML (ClinicalTrials.gov: NCT05673057). Dose escalation in cohorts 1–7 showed an acceptable safety profile and initial activity, yet with unsustained responses (four responders reported and encouraging blast reductions across additional patients).
In the ongoing cohort 8, an additional dosing timepoint was introduced to allow steeper step-up and more frequent dosing to reach the MP0533 target dose faster. Data from this cohort indicate increased rates and depth of responses, with three out of eight evaluable patients demonstrating responses (data cutoff 16 December 2024). The Company will present additional data on Cohort 8 at the European Hematology Association (EHA) Congress in June 2025.
The study protocol has been amended to improve the exposure profile of MP0533 based on the learnings from the dose escalation cohorts, and has been approved by regulatory authorities in April 2025. It foresees further MP0533 dose densification and premedication to mitigate loss of exposure, with the objective to further increase the rate, depth and duration of responses observed in cohort 8. Enrollment has started and data on the amended dosing scheme are expected in 2025.
Switch-DARPin Platform (Next-generation Immune Cell Engagers)
By employing a multi-specific Switch-DARPin, Molecular Partners aims to increase the safety and potency of T cell engagers (TCEs). Preclinical proof-of-concept in a solid tumor model for a novel CD3 Switch-DARPin TCE was presented at AACR 2025.The CD3 Switch-DARPin activates T cells specifically in the presence of cells co-expressing MSLN and epithelial cell adhesion molecule (EpCAM), increasing tumor specificity. The data presented provide further validation of Switch-DARPins and show that conditional T-cell activation with potent CD2 co-stimulation in solid tumors, but not in healthy tissues, is feasible.
Molecular Partners’ first Switch-DARPin program, MP0621, is designed to induce killing of hematopoietic stem cells (HSCs) as a next-generation conditioning regimen for HSC transplantation. The Company has presented pre-clinical proof-of-mechanism data on MP0621 in 2024. As its portfolio strategy prioritizes therapeutic candidates for oncology, MP0621 is being evaluated for partnering.
MP0317 (localized agonist)
Molecular Partners presented comprehensive biomarker analyses from the completed Phase 1 dose escalation trial of the localized CD40 agonist MP0317 in solid tumors at SITC in November 2024. MP0317 is designed to activate immune cells specifically within the tumor microenvironment by anchoring to fibroblast activation protein (FAP), which is expressed in high amounts in the stroma of various solid tumors. The Company believes this tumor-localized approach has the potential to deliver greater efficacy with fewer side effects compared to systemic CD40-targeting therapies.
Molecular Partners is in discussion with leading academic centers regarding potential investigator-initiated trials of MP0317 in 2025, in combination with immune checkpoint inhibitors and additional standard of care for patients with solid tumors.
Corporate Governance Highlights
All motions proposed by the Board of Directors at the Annual General Meeting, held in April 2025, were approved by the shareholders of the Company.
Financial and Business Outlook
For the full year 2025, at constant exchange rates, the Company expects total operating expenses of CHF 55-65 million of which around CHF 7 million will be non-cash effective costs for share-based payments, IFRS pension accounting and depreciation.
The Company's cash and cash equivalents and short-term time deposits were CHF 131 million as of March 31, 2025 and based on current operating assumptions, will be sufficient to fund its operating expenses and capital expenditure requirements well into 2027.
About DARPin Therapeutics
DARPin (Designed Ankyrin Repeat Protein) therapeutics are a new class of custom-built protein drugs based on natural binding proteins that open new dimensions of multi-functionality and multi-target specificity in drug design. The flexible architecture, intrinsic potential for high affinity and specificity, small size and high stability of DARPins offer benefits to drug design over other currently available protein-based therapeutics. DARPin candidates can be radically simple, with a single DARPin unit acting as the delivery vector to a specific target; or multispecific, with the possibility of engaging more than five targets, and combining multiple and conditional functionalities in a unique DARPin drug candidate. The DARPin platform is designed to be a rapid and cost-effective drug discovery engine, producing drug candidates with optimized properties and high production yields. DARPin therapeutics have been clinically validated across several therapeutic areas and developed through to the registrational stage.
About Molecular Partners
Molecular Partners AG is a clinical-stage biotech company pioneering the design and development of DARPin therapeutics for medical challenges other drug modalities cannot readily address. The Company has programs in various stages of pre-clinical and clinical development, with oncology as its main focus. Molecular Partners leverages the advantages of DARPins to provide unique solutions to patients through its proprietary programs as well as through partnerships with leading pharmaceutical companies. Molecular Partners was founded in 2004 and has offices in both Zurich, Switzerland and Concord, MA, USA. For more information, visit www.molecularpartners.com and find us on LinkedIn and Twitter/X @MolecularPrtnrs
For further details, please contact:
Seth Lewis, SVP Investor Relations & Strategy
Concord, Massachusetts, U.S.
seth.lewis@molecularpartners.com
Tel: +1 781 420 2361
Laura Jeanbart, PhD, Head of Portfolio Management & Communications
Zurich-Schlieren, Switzerland
laura.jeanbart@molecularpartners.com
Tel: +41 44 575 19 35
Cautionary Note Regarding Forward-Looking Statements
Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995, as amended, including without limitation: implied and express statements regarding the clinical development of Molecular Partners’ current or future product candidates; expectations regarding timing for reporting data from ongoing clinical trials or the initiation of future clinical trials; the potential therapeutic and clinical benefits of Molecular Partners’ product candidates and its RDT and Switch-DARPin platforms; the selection and development of future programs; Molecular Partners’ collaboration with Orano Med including the benefits and results that may be achieved through the collaboration; and Molecular Partners’ expected business and financial outlook, including anticipated expenses and cash utilization for 2025 and its expectation of its current cash runway. These statements may be identified by words such as “aim”, "anticipate”, “expect”, “guidance”, “intend”, “outlook”, “plan”, “potential”, “will” and similar expressions, and are based on Molecular Partners’ current beliefs and expectations. These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements. Some of the key factors that could cause actual results to differ from Molecular Partners’ expectations include its plans to develop and potentially commercialize its product candidates; Molecular Partners’ reliance on third party partners and collaborators over which it may not always have full control; Molecular Partners’ ongoing and planned clinical trials and preclinical studies for its product candidates, including the timing of such trials and studies; the risk that the results of preclinical studies and clinical trials may not be predictive of future results in connection with future clinical trials; the timing of and Molecular Partners’ ability to obtain and maintain regulatory approvals for its product candidates; the extent of clinical trials potentially required for Molecular Partners’ product candidates; the clinical utility and ability to achieve market acceptance of Molecular Partners’ product candidates; the potential that Molecular Partners’ product candidates may exhibit serious adverse, undesirable or unacceptable side effects; the impact of any health pandemic, macroeconomic factors and other global events on Molecular Partners’ preclinical studies, clinical trials or operations, or the operations of third parties on which it relies; Molecular Partners’ plans and development of any new indications for its product candidates; Molecular Partners’ commercialization, marketing and manufacturing capabilities and strategy; Molecular Partners’ intellectual property position; Molecular Partners’ ability to identify and in-license additional product candidates; unanticipated factors in addition to the foregoing that may cause Molecular Partners’ actual results to differ from its financial and business projections and guidance; and other risks and uncertainties set forth in Molecular Partners’ Annual Report on Form 20-F for the year ended December 31, 2024 and other filings Molecular Partners makes with the SEC from time to time. These documents are available on the Investors page of Molecular Partners’ website at www.molecularpartners.com. In addition, this press release contains information relating to interim data as of the relevant data cutoff date, results of which may differ from topline results that may be obtained in the future. Any forward-looking statements speak only as of the date of this press release and are based on information available to Molecular Partners as of the date of this release, and Molecular Partners assumes no obligation to, and does not intend to, update any forward-looking statements, whether as a result of new information, future events or otherwise.
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