Interim Management Statement Q3 2021 of Molecular Partners: Advancement of COVID-19 Clinical Program and Continued Immuno-Oncology Momentum

ZURICH-SCHLIEREN, Switzerland and CONCORD, Mass., Oct. 28, 2021 (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 September 30, 2021.

“COVID-19 continues to be a major concern globally, and a main focus of our efforts at Molecular Partners. As new variants emerge and novel therapeutic modalities are being developed to fight the disease alongside vaccines, the need to develop efficacious and robust therapeutics is clearer than ever. Our COVID-19 program has significantly advanced in the last quarter. Having now enrolled over 700 patients across two global late stage studies, we have accomplished much and are approaching two significant milestones. In the coming weeks and months we are preparing for futility assessment in the NIH-sponsored hospitalized study and data from our phase 2b-3 EMPATHY study in outpatients,” said Patrick Amstutz, Ph.D., Molecular Partners’ CEO. “In addition, we have maintained momentum across our two immuno-oncology clinical programs, and advanced our preclinical AML program, a truly differentiated CD3 engaging molecule with a unique mechanism of action which is beyond the feasibility of most traditional therapies.”

Research & development highlights:

Ensovibep COVID-19 antiviral program: Two global studies ongoing
In October 2021, the Phase 2b portion of the EMPATHY (ambulatory) study reached its target recruitment of 400 patients; Topline data from Phase 2b are expected in early 2022
Also in October 2021, the ACTIV-3 (hospitalized) study reached its initial target recruitment of 300 patients. A futility analysis of the study will be conducted at the next data and safety monitoring board (DSMB) assembly, in the coming weeks. Should ensovibep pass the futility analysis, the study will advance to full enrollment. Topline data are expected in 2022
Assessment of a subcutaneous formulation of ensovibep is ongoing in healthy volunteers and will provide the rationale to initiate patient studies in the coming months
Ensovibep continues to maintain full potency in vitro against all known variants of concern, including Delta variants

AMG 506 / MP0310 (FAP x 4-1BB)
Ongoing Phase 1 trials with weekly dosing
Expecting data late in 2021 or early 2022, for Amgen and Molecular Partners’ evaluation

MP0317 (FAP x CD40):
The second immuno-oncology DARPin candidate is expected to enter the clinic in Q4 2021
Strong preclinical data supports 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)
Molecular Partners’ lead AML targeting candidate selected, formally termed MP0533
Preclinical data to be presented at the ASH conference, December 2021
Expected to enter clinical trials in 2022

Molecular Partners regained global rights to abicipar, the Company’s registrational-stage ophthalmology therapeutic candidate for the treatment of neovascular age-related macular degeneration (nAMD) and diabetic macular edema (DME)
Molecular Partners is evaluating the program and will determine the appropriate next steps
Operational and financial highlights:

Strong financial position with CHF 154.3 million in cash (incl. short term deposits) as of September 30, 2021
Operating loss of CHF 47.6 million and net loss of CHF 45.9 million for the 9 months ended September 30, 2021
Company funded into H2 2023, excluding any potential payments from R&D partnerships
The Q3 2021 Financial Statements are available on the company’s website.