At a Glance: Key Milestones, Group Profile & Contents

  • Advancement of balanced portfolio of differentiated DARPin® product candidates
    offering patients a new dimension of protein therapeutics for the treatment of serious diseases
  • Key advancements made in the areas of oncology and virology

H1 2021 Research & Development Milestones

  • Initiated two global Phase 2 and 3 trials of ensovibep (MP0420), to explore safety and efficacy in ambulatory patients with COVID-19 (EMPATHY) in collaboration with Novartis, and hospitalized patients (ACTIV-3) sponsored by the National Institutes of Health (NIH)
  • Received FDA Fast Track designation for ensovibep for the treatment of COVID-19 in both hospitalized and ambulatory settings
  • Initiated and fully enrolled Phase 2a single arm study of ensovibep in the Netherlands in patients with mildly symptomatic COVID-19, with data expected to be presented in a scientific conference in H2 2021

• Reported that in vitro studies indicate that ensovibep maintains potency against all known SARS-CoV-2 variants of concern, including Delta and Lambda

  • Presented data further supporting the MP0317, T-cell engager, and Peptide-MHC oncology programs at AACR
  • In August, announced receipt of global rights of abicipar pegol for the treatment of neovascular AMD (nAMD) and Diabetic Macular Edema, following termination of the license and collaboration agreement by AbbVie Inc.

H1 2021 Leadership & Governance Milestones

  • Elected Agnete Fredriksen and Dominik Höchli to the Board of Directors at the Annual General Meeting of April 21, 2021

H1 2021 Financial Milestones

  • Successfully completed initial public offering of American Depositary Shares ("ADSs") on the Nasdaq, raising $63.8 million (CHF 58.8 million) in gross proceeds to support ongoing operations into H2 2023
  • Ongoing strong financial position with CHF 174.3 million in cash and short-term deposits as of June 30, 2021
  • Net cash outflow from operating activities of CHF 52.5 million in H1 2021
  • FY 2021 expense guidance maintained at CHF 65-75 million

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Group Profile

Molecular Partners 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.

Share Information

  • Listed on SIX Swiss Exchange (ticker symbol: MOLN; ISIN CH0256379097) since Nov. 2014
  • Listed on Nasdaq (ticker symbol: MOLN) since June 2021
  • 32,269,285 shares outstanding as of June 30, 2021
  • CHF 608 million market capitalization as of June 30, 2021
  • Free float of 84% as per SIX Swiss Exchange definition

Contents

At a Glance: Key Milestones and Contents................................................................................

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  • H1 2021 R&D, Partnership & Team Milestones
  • H1 2021 Financial Milestones
  • Company Profile & Share Information
  • Contents

Shareholder Letter.......................................................................................................................

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Financial Summary........................................................................................................................

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  • Results and Overview
  • Financial Highlights
  • Outlook 2021 and Financial Calendar
  • Development of Employee Base

Financial Reports ..........................................................................................................................

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  • IFRS Condensed Consolidated Interim Financial Statements
  • Auditor's Report on Review of Condensed Consolidated Interim Financial Statements

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To Our Shareholders

We are committed to leveraging our leadership in DARPin® therapeutics to deliver a unique class of custom-built protein therapeutics that go beyond the limits of current treatments for cancer, in virology as well as for other serious diseases.

The COVID-19 pandemic continued to dominate also the first half of 2021. Nonetheless, in the course of the first semester, we were able to strongly expand our global clinical presence and collaboration with Novartis as the evolving COVID-19 pandemic continued to underscore the need for effective antiviral therapeutics.

As a now dual-listed company in Switzerland and the United States, our expanded investor base enables us to accelerate our mission to deliver a new class of medicines to people living with cancer and infectious diseases.

To have entered two ongoing, late-stage trials of ensovibep further illustrates our rapid design and development capabilities, and in addition to the COVID-19 program we are focused on expanding into new antiviral applications of the DARPin® platform while moving towards a new phase for our immuno-oncology programs.

H1 2021 Milestones and Corporate Highlights

In the following, we summarize the advancements and status of our candidates as well as the initiatives for the individual therapeutic areas virology, oncology and ophthalmology.

Further, we provide an overview on the highlights in terms of Leadership & Governance of our organization.

Antiviral program: Rapid development of trispecific antiviral DARPin® candidate ensovibep in multiple international clinical trials

Molecular Partners advanced in 2021 with strong momentum for our lead antiviral candidate, ensovibep, which has progressed in the second quarter of 2021 into two ongoing, late-stage global clinical studies, EMPATHY and ACTIV-3, in collaboration with Novartis and the NIH, respectively. Thus far, ensovibep has provided positive Phase 1 data and continued to maintain potency in laboratory studies against all known COVID-19 variants of concern.

In March of 2021, jointly with our collaboration partner Novartis we announced that the National Institutes of Health (NIH) selected ensovibep for inclusion in a global phase 3 randomized, controlled clinical trial as part of NIH's Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) program. The international master protocol ACTIV-3 is designed to evaluate the safety and efficacy of various therapies for the treatment of adults hospitalized with a COVID-19 diagnosis. A sub-study of ACTIV-3 evaluating ensovibep began enrolling hospitalized patients in June 2021 and is currently enrolling patients across seven countries. Topline data from this study are expected in 2022.

In May of 2021, together with Novartis we announced the start of the clinical trial EMPATHY, a global phase 2 - 3 study, to explore the use of ensovibep for the treatment of COVID-19 in patients who are in the early stages of infection, to prevent worsening symptoms and hospitalization. Our collaboration partner Novartis is conducting the clinical trial for ensovibep, with Molecular Partners

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Molecular Partners AG published this content on 26 August 2021 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 26 August 2021 05:10:04 UTC.