Interim Management Statement Q3 2020 of Molecular Partners: Emergence of New Opportunities and Strong Platform Validation of DARPin® Therapeutics
Zurich-Schlieren, Switzerland, October 29, 2020. Molecular Partners AG (SIX: MOLN), a clinical-stage biotech company that is developing a new class of custom-built protein drugs known as DARPin® therapeutics, announced today its interim management statement for the period ending September30, 2020.
“Responding to the global COVID-19 pandemic requires an unprecedented effort on the part of therapeutics innovators like Molecular Partners. We have used our pioneering knowledge of the unique DARPin® class to rapidly deliver what could be the first multi-specific treatment options for patients, which have formed the basis for a pivotal collaboration with Novartis. Its global development, regulatory & commercial capabilities will help rapidly bring the program forward with the potential to change the face of the pandemic,” said Patrick Amstutz, Ph.D., Chief Executive Officer of Molecular Partners. “Our work to date along with this highly validating partnership encourage our pursuit of other new initiatives in virology, in addition to our innovative oncology programs. We believe this pipeline evolution is a continued demonstration of the strength of our DARPin® leadership that has opened new avenues for delivering therapeutics that can achieve clinical outcomes other modalities cannot.”
Research and Development Highlights
- Collaboration with Novartis for co-development of MP0420 and MP0423, including options for global commercialization; leveraging innovative protein drug development expertise of Molecular Partners with Novartis’ expertise in global development and commercialization
- Terms of the Novartis agreement include total cash considerations of CHF 210 million ($230 million USD), comprised of an upfront payment, equity purchase, and milestones, as well as a 22% royalty on sales in commercial territories
- Receipt of reservation fee from Swiss Government, securing a minimum of 200,000 doses of MP0420 with provisions for up to an additional 3,000,000 doses
- First-in-human studies of MP0420 expected to begin in November 2020
- Continued AMG 506 (MP0310) (FAP x 4-1BB) phase 1 dose escalation study. Presentation of initial data describing dosing, safety and proof of mechanism anticipated by the end of 2020, with potential initiation of combination studies by Amgen in H2 2021
- MP0274 (HER2+) phase 1 study to conclude after dose escalation with no additional studies planned. In total, 22 patients were treated with MP0274, the drug was found to be safe and well tolerated with a PR as best response.
- MP0317 (FAP x CD40) on track for Clinical Trial Application filing expected before the end of 2020 with First-in-human study start expected to begin in H1 2021
Financial and Operational highlights:
- Gross proceeds of CHF 80.2 million from share capital increase received in July 2020, providing anticipated financing into 2022
- Cash and short-term deposits of CHF 133.8 million as of September 30, 2020
- Net cash used in operating activities of CHF 31.3 million in first nine months of 2020
- Operating loss of CHF 38.3 million and net loss of CHF 41.2 million in first nine months of 2020
- On December 17, 2020 the Company plans to host an Investor & Analyst Day, highlighting recent accomplishments in both clinical development and research. This event will be held virtually, and will include commentary from senior management and Key Opinion Leaders.