Interim Management Statement Q1 2022 of Molecular Partners: Cash Runway into 2026 and Portfolio Progress Highlight Strategic Momentum

ZURICH-SCHLIEREN, Switzerland and CONCORD, Mass., May 12, 2022 (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 its interim management statement for the quarter ending March 31, 2022.

“Following a significant capital inflow in January, resulting from Novartis exercising its right to in-license global rights to ensovibep, we are leveraging our strong cash position to follow our strategy; to prioritize candidates where DARPins have an innate advantage over other approaches. Programs like ensovibep, the breakthrough design of MP0533 and our new research in radioligand therapies, showcase the success of our evolved strategy, which emphasizes highly differentiated molecules that can rapidly demonstrate clear activity and benefit for patients,” said Patrick Amstutz, Molecular Partners’ CEO. “We continue to support Novartis on next steps for ensovibep’s global strategy as we advance our internal portfolio, building on the strong clinical performance our DARPins candidates have continually demonstrated.“

Research & development highlights:

  • Ensovibep COVID-19 antiviral program: Positive Phase 2 results, Option exercised by Novartis
    • Part A of the EMPATHY global clinical trial met its primary endpoint with a statistically significant reduction in viral load over eight days in the ensovibep arms compared to placebo
    • Secondary EMPATHY endpoint of hospitalization and/or emergency room (ER) visits related to COVID-19, or death showed an overall 78% reduction in relative risk of events across all ensovibep arms compared to placebo
    • In April, the results of the EMPATHY Part A study were presented as a late breaker at the 2022 European Congress of Clinical Microbiology and Infectious Diseases (ECCMID)
    • Novartis exercised the option to license all rights to ensovibep, triggering a CHF 150 million payment to Molecular Partners
    • Novartis requested Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) for ensovibep. As previously reported by Novartis, the EUA remains under review, and the FDA has indicated that Phase 3 data will be required prior to authorization. Novartis is currently engaged in developing a Phase 3 protocol for alignment with the FDA’s recommendations
  • MP0310 (FAP x 4-1BB)
    • Amgen returned global rights for MP0310 following a strategic pipeline review. The ongoing Phase 1 study is expected to continue as planned, with data expected later in 2022 that will inform further business development activity
  • MP0317 (FAP x CD40):
    • The Phase 1 open-label dose escalation study, initiated in Q4 2021, continues in patients with solid tumors known to express FAP. Initial data from this study is expected in the second half of 2022
    • In March 2022, preclinical data were published in the research journal Cancer Immunology Research1 supporting MP0317’s potential to deliver tumor-localized immune activation while avoiding systemic toxicity seen with other CD40-targeting agents
  • MP0533 (CD33 x CD70 x CD123 x CD3)
    • Following continued promising preclinical data supporting the unique design and mechanism of this candidate, a lead molecule was selected and named MP0533. It is expected to enter clinical development in 2022
    • New in vivo data from the MP0533 program will be presented at the European Hematology Association Congress (EHA2022) which will be held in Vienna, Austria from June 9 to 12

Q1 2022 operational and financial highlights:

  • Strong financial position with CHF 296.2 million in cash (including short term deposits) as of March 31, 2022
  • Revenue of CHF 172.8 million primarily due to payment received from Novartis upon exercise of option to in-license global rights to ensovibep
  • Net cash from operating activities of CHF 163.6 million in Q1 2022
  • Operating profit of CHF 152.6 million and net profit of CHF 153.1 million in Q1 2022
  • Company expected to be funded into 2026, excluding any potential payments from R&D partnerships
  • The Q1 2022 Financial Statements are available on the company’s website

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