Molecular Partners Q3 2024 Interim Management Statement: Multiple Updates Across Portfolio, Radio-DARPin candidate MP0712 preparing for clinical entry, MP0533 Phase 1 on-going
Molecular Partners (MOLN) reported its Q3 2024 interim results, highlighting progress across its portfolio. The company's Radio-DARPin candidate MP0712 is preparing for clinical entry in 2025. The company strengthened its agreement with Orano Med to co-develop four 212Pb-based Radio-DARPin candidates. Financial outlook remains strong with CHF 143.6 million in cash as of September 30, 2024, funding operations into 2027. The company expects total operating expenses of CHF 65-70 million in 2024. A recent US offering raised approximately USD 20 million through ADS sales at USD 5.49 per share.
Molecular Partners (MOLN) ha riportato i risultati intermedi per il terzo trimestre del 2024, evidenziando progressi nel suo portafoglio. Il candidato Radio-DARPin dell'azienda, MP0712, si sta preparando per l'ingresso clinico nel 2025. L'azienda ha rafforzato l'accordo con Orano Med per co-sviluppare quattro candidati Radio-DARPin basati su 212Pb. Le prospettive finanziarie rimangono solide con CHF 143,6 milioni in cassa al 30 settembre 2024, coprendo le operazioni fino al 2027. L'azienda prevede spese operative totali tra CHF 65 e 70 milioni nel 2024. Un recente collocamento negli Stati Uniti ha raccolto circa 20 milioni di USD attraverso la vendita di ADS a 5,49 USD per azione.
Molecular Partners (MOLN) informó sus resultados intermedios del tercer trimestre de 2024, destacando el progreso en su cartera. El candidato Radio-DARPin de la compañía, MP0712, se está preparando para la entrada clínica en 2025. La compañía fortaleció su acuerdo con Orano Med para co-desarrollar cuatro candidatos Radio-DARPin basados en 212Pb. Las perspectivas financieras siguen siendo sólidas con CHF 143,6 millones en efectivo al 30 de septiembre de 2024, financiando las operaciones hasta 2027. La empresa espera gastos operativos totales de entre CHF 65 y 70 millones en 2024. Una reciente oferta en EE. UU. recaudó aproximadamente 20 millones de USD a través de ventas de ADS a 5,49 USD por acción.
몰레큘러 파트너스(MOLN)는 2024년 3분기 중간 결과를 보고하며 포트폴리오 전반에 걸쳐 진행 상황을 강조했습니다. 회사의 라디오-DARPin 후보인 MP0712는 2025년 임상 진입을 준비 중입니다. 이 회사는 212Pb 기반의 네 개의 라디오-DARPin 후보를 공동 개발하기 위해 Orano Med와의 계약을 강화했습니다. 재무 전망은 2024년 9월 30일 기준으로 CHF 1억 4360만의 현금을 보유하고 있어 2027년까지 운영 자금을 지원합니다. 회사는 2024년 총 운영 비용이 CHF 6500만에서 7000만 사이일 것으로 예상하고 있습니다. 최근 미국에서의 공모는 주당 5.49 USD의 가격으로 ADS 매각을 통해 약 2000만 USD를 모금했습니다.
Molecular Partners (MOLN) a publié ses résultats intermédiaires pour le troisième trimestre 2024, mettant en avant les avancées de son portefeuille. Le candidat Radio-DARPin de l'entreprise, MP0712, se prépare à entrer en clinique en 2025. L'entreprise a renforcé son accord avec Orano Med pour co-développer quatre candidats Radio-DARPin basés sur le 212Pb. Les perspectives financières restent solides avec 143,6 millions CHF en liquidités au 30 septembre 2024, finançant les opérations jusqu'en 2027. L'entreprise s'attend à des dépenses d'exploitation totales comprises entre 65 et 70 millions CHF en 2024. Une offre récente aux États-Unis a permis de lever environ 20 millions USD par la vente d'ADS à 5,49 USD par action.
Molecular Partners (MOLN) berichtete über die Zwischenresultate des dritten Quartals 2024 und hob die Fortschritte in seinem Portfolio hervor. Der Radio-DARPin-Kandidat MP0712 der Firma bereitet sich auf den klinischen Eintritt im Jahr 2025 vor. Das Unternehmen verstärkte seine Vereinbarung mit Orano Med zur gemeinsamen Entwicklung von vier 212Pb-basierten Radio-DARPin-Kandidaten. Die Finanzprognose bleibt stark mit CHF 143,6 Millionen an liquiden Mitteln per 30. September 2024, die den Betrieb bis 2027 finanzieren. Das Unternehmen erwartet für 2024 Gesamtausgaben von CHF 65-70 Millionen. Ein kürzliches Angebot in den USA erzielte etwa 20 Millionen USD durch den Verkauf von ADS zu je 5,49 USD.
- Strong cash position of CHF 143.6 million funding operations into 2027
- Successful USD 20 million capital raise through ADS offering
- Expanded partnership with Orano Med for co-development of four Radio-DARPin candidates
- MP0533 showing acceptable tolerability profile in Phase 1 trials
- Operating expenses expected to reach CHF 65-70 million in 2024
- Shareholder dilution from new ADS offering of 3,642,988 shares
Insights
The Q3 update reveals a strong financial position with
The strategic revision of the Orano Med partnership doubles Molecular Partners' commercialization rights from one to two programs, significantly enhancing future revenue potential. The addition of HBM Healthcare Investments as a new investor adds credibility and institutional backing.
The pipeline progress is noteworthy, particularly with MP0712, their lead Radio-DARPin candidate. The DLL3 target is expressed in
MP0533's ongoing Phase 1 trial for AML shows an acceptable safety profile, with protocol amendments aimed at optimizing dosing. The multi-platform approach with Radio-DARPin, Switch-DARPin and traditional DARPin technologies provides multiple shots on goal in oncology.
Radio-DARPin Therapy (RDT) Candidate MP0712 supported by in vivo data presented at the European Association of Nuclear Medicine (EANM) Congress; first-in-human start and initial clinical data expected in 2025
RDT strategic agreement with Orano Med revised and strengthened: both companies to co-develop four 212Pb-based RDT candidates, including MP0712
MP0533 phase 1 dose escalation study continues; update to be presented at the American Society for Hematology Annual Meeting (ASH); protocol being amended to improve treatment exposure
CD3 Switch-DARPin proof-of-mechanism to be presented at the Society for the Immunotherapy of Cancer Annual Meeting (SITC); update on Switch-DARPin MP0621 to be presented at ASH
MP0317 Phase 1 biomarker data presented at the International Cancer Immunotherapy Conference (CICON); additional biomarker data to be shared at SITC
Outlook: Funded into 2027 with cash and short-term time deposits of CHF 143.6 million as of September 30, 2024, Molecular Partners expects total operating expenses of CHF 65-70 million in 2024.
ZURICH-SCHLIEREN, Switzerland and CONCORD, Mass., Oct. 31, 2024 (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 third quarter of 2024.
“In the last quarter we continued to execute our plan to bring our first Radio-DARPin program to IND submission, and into the clinics. DLL3 remains a highly interesting target that is gaining significant attention. Our team presented additional preclinical data showing that MP0712 is safe and efficacious in a highly relevant tumor model, with DLL3 expression levels matching those in human tumors," said Patrick Amstutz, Ph.D., Molecular Partners’ Chief Executive Officer. "In addition, we strengthened our relationship with our partner Orano Med, ensuring that both parties will have the opportunity to bring two Radio-DARPin products to market, for a total of four. Lastly our recent capital raise allows us additional financial flexibility into 2027 with participation from new, specialized investors and supportive existing investors.”
Financial and Business Outlook
For the full year 2024, at constant exchange rates, the Company reiterates its guidance for total expenses of CHF 65–70 million. Approximately CHF 7 million of this will be non-cash effective costs for share-based payments, pension accounting and depreciation. This guidance does not include any potential receipts from R&D collaborators.
With CHF 143.6 million in cash and short-term time deposits and no debt as of September 30, 2024, the Company expects to be funded into 2027, excluding any potential receipts from R&D collaborators.
On October 25, 2024, Molecular Partners announced the pricing of an underwritten offering in the US of 3’642’988 American Depositary Shares (ADSs) representing 3’642’988 ordinary shares at an offering price of USD 5.49 per ADS. The total gross proceeds amount to approximately USD 20 million. The offering included participation from a new investor HBM Healthcare Investments Ltd, which is a leading healthcare investor, as well as multiple existing investors. Leerink Partners and TD Cowen acted as joint bookrunning managers for the offering. LifeSci Capital acted as lead manager for the offering, and Zürcher Kantonalbank (ZKB) served as settlement agent. Molecular Partners currently intends to use the net proceeds from this offering, together with its existing cash and cash equivalents, for development and expansion of its radiopharmaceutical pipeline and platform (Radio-DARPin Therapeutics) and for working capital and other general corporate purposes. Subsequent to the offering, the Company has (proforma) cash and short-term time deposits in the amount of CHF 158 million, with 40,363,095 issued shares.
Research & Development Highlights
MP0712 and Radio-DARPin Therapy (RDT): Preparing for IND submission and clinical entry in 2025
Molecular Partners has leveraged the intrinsic properties of DARPins, such as small size, high affinity and specificity, to engineer Radio-DARPins as ideal vector candidates for radiopharmaceutical therapeutics and to create a Radio-DARPin Therapy (RDT) platform amenable to a broad range of tumor targets. Historically, small protein-based vectors faced challenges with kidney accumulation and toxicity, as well as suboptimal tumor uptake. Molecular Partners’ RDT platform addresses these limitations with its half-life extension technologies and surface engineering approaches, while preserving the advantages of the small protein format.
MP0712 is a 212Pb-based Radio-DARPin Therapeutic (RDT) candidate targeting the tumor-associated protein delta-like ligand 3 (DLL3). MP0712 is being co-developed with Orano Med, a clinical stage pioneer of targeted alpha therapies using the lead isotope 212Pb. Molecular Partners and Orano Med anticipate initiating first-in-human studies in 2025, pending regulatory clearance. Initial clinical data of MP0712 is also anticipated in 2025.
In October 2024, Molecular Partners presented new in vivo data at the EANM Congress. MP0712 demonstrated high affinity and specificity for DLL3 and a favorable safety profile. DLL3 is a highly relevant target for radiopharmaceutical therapy due to its abundant expression in tumors of patients with small cell lung cancer (present in >
On October 22, 2024, Molecular Partners and Orano Med signed a revised and strengthened agreement to co-develop 212Pb-based Radio-DARPin Therapeutics. This revision builds on the original agreement signed in January 2024. Under the revised agreement, both companies will co-develop four Radio-DARPin programs; each company will have the right to commercialize two programs (previously one each). Molecular Partners will hold commercialization rights to the second nominated Radio-DARPin candidate, in addition to rights to the first program MP0712.
In addition to the updates above, Molecular Partners continued to progress its RDT portfolio with projects through a partnership with Novartis, and is evaluating additional targets for RDT programs. An update on the broader RDT portfolio is expected to be shared in the first half of 2025.
MP0533 (multispecific T cell engager)
MP0533, a novel tetra-specific T cell-engaging DARPin, is currently being evaluated in a Phase 1/2a clinical trial for patients with relapsed/refractory acute myeloid leukemia (r/r AML) and myelodysplastic syndrome/AML (MDS/AML) (ClinicalTrials.gov: NCT05673057). The trial is currently enrolling patients in Cohort 8. MP0533’s mode of action is designed to preferentially kill AML cells (blasts, leukemic progenitor and stem cells) that express any combination of the three cell surface antigens CD33, CD123, and CD70, while sparing healthy cells, which tend to express only one or none of these targets. The immune activation against the malignant cells is achieved through CD3-mediated T-cell engagement.
As shared in August 2024, MP0533 showed an acceptable tolerability profile with the majority of adverse events reported being infusion-related reactions and cytokine release syndrome. Based on this observed tolerability profile and initial antitumor activity data, and following discussion with treating physicians and key opinion leaders, Molecular Partners is amending the protocol to further increase dosing and improve the exposure profile of MP0533.
Molecular Partners plans to present the next clinical update of the program at the American Society of Hematology (ASH) Annual Meeting in San Diego on December 7–10, 2024, and data following the protocol amendment are expected in 2025.
Switch-DARPin Platform (next-gen immune cell engagers)
The Switch-DARPin platform provides a logic-gated “on/off” function (the “Switch”) to multi-specific DARPin candidates leading to target activation only in the presence of defined antigens. The objective is conditional activation of a targeted immune response.
MP0621 is a Switch-DARPin candidate designed to induce killing of hematopoietic stem cells as a next-generation conditioning regimen for HSCT. The in vivo proof-of-mechanism data, as presented at EHA 2024, demonstrate that MP0621 could be an efficient next-generation conditioning regimen for autologous HSCT. At present, the non-human primate data do not indicate that MP0621 would serve as a treatment for AML. As Molecular Partners’ portfolio strategy prioritizes therapeutic candidates for oncology, MP0621 is being evaluated for partnering. The Company plans to present a preclinical update on MP0621 at ASH 2024.
Proof-of-concept preclinical data on an additional Switch-DARPin candidate, namely a CD3 Switch-DARPin T cell engager for solid tumors, will be presented at SITC 2024 on November 9, 2024. The CD3 Switch-DARPin targets the highly validated immunostimulatory protein CD3 to deliver a T cell-engager (TCE) mechanism with enhanced function via engagement of additional receptors on the surface of T cells. TCEs are a powerful class of immuno-oncology therapies but have faced a range of challenges such as toxicity, poor T cell fitness and immune suppression, particularly in solid tumors. By employing a multi-specific Switch approach, Molecular Partners aims to broaden the therapeutic space for T cell engagers.
MP0317 (localized agonist)
MP0317 is a CD40 agonist designed to activate immune cells specifically within the tumor microenvironment (TME) by anchoring to fibroblast activation protein (FAP) which is expressed in high amounts around tumors. This tumor-localized approach has the potential to deliver greater efficacy with fewer side effects compared to systemic CD40-targeting therapies.
In September 2024, the Company presented details of the transcriptomic analysis from its completed Phase 1 study at CICON 2024. The analysis of patient biopsies pre- and post-treatment with MP0317 showed that this molecule remodels the tumor microenvironment by inducing infiltration of B, plasma, dendritic, and T follicular helper cells.
Molecular Partners plans to share a comprehensive biomarker analysis of its completed Phase 1 study at SITC on November 9, 2024.
The positive Phase 1 data support further clinical evaluation of MP0317 in combination with complementary anticancer therapies and demonstrated the ability of the DARPin design to deliver on a targeted, tumor-localized CD40 activation mechanism. Molecular Partners is in discussion with leading academic centers regarding potential investigator-initiated combination trials.
Expected Financial Calendar
March 6, 2025 | Corporate Highlights Q4 2024 and Key Financials for Full Year 2024 |
April 16, 2025 | Annual General Meeting |
May 15, 2025 | Interim Management Statement Q1 2025 |
The latest timing of the above events can be viewed on the investor section of the corporate website.
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 2024 and its expectation of its current cash runway and the expected use of proceeds from the underwritten offering. These statements may be identified by words such as “aim”, “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 impact Molecular Partners’ 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, 2023 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.
FAQ
What is Molecular Partners' (MOLN) cash position as of Q3 2024?
How much did Molecular Partners (MOLN) raise in its October 2024 ADS offering?
When will Molecular Partners (MOLN) begin human trials for MP0712?