Molecular Partners Provides Updates at 41st Annual JPM Healthcare Conference

Rhea-AI Summary

Molecular Partners AG (SIX: MOLN; NASDAQ: MOLN) announced progress in its infection and oncology portfolios, highlighting the development of a DARPin Radioligand Therapy platform targeting DLL3, a protein associated with certain tumors. The company reported unaudited cash reserves of approximately CHF249 million, expected to last until 2026. A collaboration with Novartis aims to address global health threats. Upcoming milestones include patient recruitment for clinical studies in early 2023 and a first data readout for the MP0533 study.

Positive

• DARPin Radioligand Therapy platform is progressing with DLL3 as the first target.
• Unaudited cash of approximately CHF249 million ensures a cash runway into 2026.
• Collaboration with Novartis to address infectious disease threats could enhance research capabilities.
• Upcoming milestones in 2023 indicate active clinical development.

Negative

• Withdrawal of the EUA application for ensovibep may hinder COVID-19 therapeutic development.
• Ensovibep is not currently in clinical development, limiting potential revenue streams.

ZURICH-SCHLIEREN, Switzerland and CONCORD, Mass., Jan. 08, 2023 (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, today announced several developments in its infectious disease and oncology portfolios. These include:

• DARPin Radioligand Therapy platform progressing well. Disclosure of the tumor-associated protein Delta-like ligand 3 (DLL3) as the first target. Expression of DLL3 is low in healthy tissue but significantly increased in certain tumor types, providing an opportunity for selective targeting.
• Year-end 2022 unaudited cash and short-term deposits ~CHF249m. Company continues to maintain expected cash runway into 2026.*
• Molecular Partners and Novartis signed a non-binding letter of intent to negotiate a Research Framework Agreement with a primary focus on emerging infectious global health threats. The Parties agree that the Definitive Agreement if concluded, shall contain provisions covering research plans, governance, development and commercialization, intellectual property, and the potential to prioritize future pandemic projects
  

The company expects milestones in 2023 to include:

• Q1 2023: The recruitment of the first patient in the company’s phase 1 study of MP0533 (CD33 X CD123 X CD70 X CD3), a novel tri-specific t-cell engager for the treatment of AML and High Risk MDS
• 1H 2023: Complete recruitment in the dose escalation of the Phase 1 trial of the company’s MP0317 (FAP X CD40) program for the treatment of solid tumors
• H1 2023: Scientific presentations of DARPin radioligand therapies and their potential differentiation as tumor targeting moiety
• Formal selection of DLL3 DARPin RLT clinical candidate  
• Q4 2023: A first data readout from the Phase 1 study of MP0533
  

Ensovibep Update:

• Molecular Partners was informed by its partner Novartis that it has submitted a request to withdraw the Emergency Use Authorization (EUA) application from the U.S. Food and Drug Administration (FDA) for ensovibep, a DARPin therapeutic candidate to treat COVID-19.
• As previously disclosed, ensovibep is not presently in clinical development.

Patrick Amstutz, CEO of Molecular Partners, will present at the 41^st Annual JP Morgan Healthcare Conference on Wednesday, January 11 at 10:30 AM ET (4:30 PM CET). A webcast will be accessible on the Molecular Partners website, under the Events tab.

*Unaudited financials. YE audited results will be available March 9, 2023

About Molecular Partners AG 
Molecular Partners AG is a clinical-stage biotech company developing DARPin therapeutics, a new class of custom-built protein drugs designed to address challenges current modalities cannot. The Company has formed partnerships with leading pharmaceutical companies to advance DARPin therapeutics in the areas of ophthalmology, oncology, and infectious disease, and has compounds in various stages of clinical and preclinical development across multiple therapeutic areas. www.molecularpartners.com; Find us on Twitter - @MolecularPrtnrs

For further details, please contact:
Seth Lewis, SVP Investor Relations
seth.lewis@molecularpartners.com
Tel: +1 781 420 2361

Antonio Ligi, Head of Communications
Zurich-Schlieren, Switzerland
antonio.ligi@molecularpartners.com
Tel: +41 79 723 36 81

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, the selection and development of future antiviral or other programs, and Molecular Partners’ expected expenses and cash utilization for 2022 and its expectation that its current cash resources will be sufficient to fund its operations and capital expenditure requirements into 2026. These statements may be identified by words such as “believe”, “expect”, “may”, “plan”, “potential”, “will”, “would” and similar expressions, and are based on Molecular Partners AG’s 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 impact of the COVID-19 pandemic 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; and other risks and uncertainties that are described in the Risk Factors section of Molecular Partners’ Annual Report on Form 20-F for the fiscal year ended December 31, 2021 filed with Securities and Exchange Commission (SEC) on March 15, 2022 and other filings Molecular Partners makes with the SEC. These documents are available on the Investors page of Molecular Partners’ website at www.molecularpartners.com. 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 are the key developments announced by Molecular Partners on January 8, 2023?

Molecular Partners announced progress in its DARPin therapy and a collaboration with Novartis, along with an update on its cash reserves.

What is the significance of the DLL3 targeting in Molecular Partners' therapy?

DLL3 is a tumor-associated protein that allows for selective targeting in certain cancers, enhancing treatment options.

What is the current financial position of Molecular Partners as of January 2023?

The company reported unaudited cash and short-term deposits of approximately CHF249 million.

What is the status of the EUA application for ensovibep?

Molecular Partners' partner Novartis submitted a request to withdraw the EUA for ensovibep, which is not in clinical development.

What milestones is Molecular Partners expecting in 2023?

Key milestones include patient recruitment for MP0533 in Q1 2023 and data readout from its Phase 1 study in Q4 2023.