GlobeNewswire Inc | Jan 10, 2022 01:17AM EST

January 10, 2022

-- Topline results from the randomized, placebo-controlled EMPATHY Part A study in acute COVID-19 ambulatory patients comparing single intravenous dosesof ensovibep, a DARPin antiviral therapeutic candidate vs. placebo, met the primary endpointof viral load reduction over eight days

-- The secondary endpoint of hospitalization and/or ER visits related to COVID-19, or deathshowed an overall 78% reduction in risk of events acrossensovibeparms compared to placebo;No deaths were observed in the ensovibep treatment arms -- A total of 407 patients were recruited in the Phase 2 study and ensovibep was safe and well-tolerated at all doses (75mg, 225mg and 600mg) with 75mg the planneddose forfurtherdevelopment -- Ensovibep continues to maintain potent in vitro pan-variant activity against all variants of concern identified so far, including Omicron -- Ensovibep is a multi-specific DARPin(Designed Ankyrin Repeat Protein),specifically designed to block the receptor binding domains of SARS-CoV-2 spike protein through highly potent and cooperative binding,making it challenging for escape mutants -- Novartis confirms it will exercise its option to in-licenseensovibepfrom Molecular Partners,accelerate manufacturing scale-up,and plans to seek expeditedregulatory authorizationsglobally first via the U.S. Food and Drug Administrations (FDA) Emergency Use Authorization (EUA) -- Upon completion of in-licensing, Molecular Partners will receive a milestone payment of 150M CHF and be entitled to a 22% royalty on sales of ensovibep in commercial territories

ZURICH-SCHLIEREN, Switzerland and CONCORD, Mass., Jan. 10, 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, and Novartis today announced that Part A of the EMPATHY clinical trial1, that compared single intravenous dosesof ensovibep, a DARPin antiviral therapeutic candidate vs. placebo to treat COVID-19, met the primary endpoint of viral load reduction over eight days. The two secondary endpoints also showed clinically meaningful benefit over placebo (1) composite endpoint of hospitalizationand/orEmergency Room (ER) visitsordeath, and (2) timeto sustained clinical recovery.Novartis confirms it will now exercise itsoption to in-license ensovibep from Molecular Partners and, following exercise of the option, will seek expedited access globally, first via the FDAs EUA process.

The global EMPATHY clinical trial, which is being conducted byNovartis, with Molecular Partners as sponsor, is a randomized,double-blind,placebo controlledstudy in ambulatory (non-hospitalized) adult patients with COVID-19.EMPATHYPart Aenrolled 407 patients to identify a dose of ensovibep with optimal safety and efficacyandrecruited patients in the USA, South Africa, India, theNetherlands,and Hungarytoexplore three doses: 75mg, 225mg and 600mg.

Results fromthestudy showed thattheprimary endpoint was met witha statistically significant reduction in viral loadovereight days, compared to placebo, for all three dosing arms. The secondary endpoint ofhospitalization and/or ER visitsrelated to COVID-19,ordeathshowedan overall78% reductionin risk of events across ensovibep armscompared to placebo.Treatment arms were generally balanced in terms of demographic,baselineand diseasecharacteristics.The placebo arm with 99 patients had a total of six events(event rate of6%);five patients were hospitalized, two of whom died due to worsening of COVID-19andone patient had an ER visitonly. In the 301 patients treated withensovibep, there were four events; hospitalizations occurred in two patientsand two needed to visit ER(event rate of1.3%). No deaths occurred in any of the patients treated with ensovibep. All doses were well-tolerated and no unexpected safety issues were identified for any of the doses2.The lowest dose of 75mg is the planned dose for further development.The data will now undergo further review so that Novartis and Molecular Partners can determine the appropriate next steps for the program.

Theseencouraging results come at a time whenthe need for therapieswith pan-variant activity, such as ensovibep,has never been greater.We are incredibly excited about the opportunity to provide a potential therapeutic option for patients around the world who require access to effective COVID-19 treatments,said Patrick Amstutz, Ph.D., CEO of Molecular Partners. Todays data are a culmination of a persistent team effort,betweenourselvesand Novartis,to deliver a tailored antiviral with demonstrated safety and efficacy in global clinical trials. AspioneersofDARPin therapeutics,ourteam has theuniqueability torapidlygenerateand developmulti-specificDARPintherapeutics.We look forward to continue to demonstrateour capabilities and the potential of our pipeline in oncology and virology for patients in need.

As the SARS-CoV-2 virus evolves, a multi-solution strategy is needed to combat the pandemic and there will be a need for antiviral treatments to complement the global vaccination efforts. Despite availability of vaccinations, there continues to be disease transmission, either through pockets of unvaccinated populations, in patients with compromised immune systems and co-morbidities or through emerging variants, and breakthrough infections are likely tocontinue.A recentin vitroanalysis3also showed that ensovibep maintains full neutralization of thepseudovirusescontainingthe mutationsidentical to the Omicronvariant of concern.

We are pleased that the results from the EMPATHY trial demonstrate the positive therapeutic effect of ensovibep, with the potential to be an important new treatment option to combat the rapidly evolving SARS-CoV-2 pandemic, said Vas Narasimhan, CEO of Novartis. As COVID-19 continues to burden healthcare systems across the globe, a range of treatments will be needed, and Novartis is proud to continue our collaboration with Molecular Partners on this unique treatment for COVID-19 and contribute ensovibep to this suite of options.

Given the pressing public health emergency and the rapid spread of the Omicronvariant across the world, Novartis and Molecular Partners are in close liaison with regulatory bodies to seek expedited review and approval of ensovibep as soon as possible.If approved, ensovibep will be the first multi-specific antiviral molecule for the treatment of COVID-19.

Novartis has informed Molecular Partners of its intent to option its exclusive license to global rights of ensovibep, which will lead to a milestone payment of CHF 150m. In addition, Molecular Partners will be eligible to receive 22% royalty on sales. Molecular Partners has agreed to forgo royalties in lower income countries and is aligned with Novartis plans to ensure affordability based on countries needs and capabilities. With the decision made to exercise theoption, Novartis will become responsible for development, manufacturing,distributionand commercializationactivitiesof ensovibep.Novartis has already initiatedscale-up activities in its large-scalebiologicsproduction facilities.

Financial guidance updateThe Company expects approximately CHF 133 million cash and cash equivalents as per December 31, 2021. Upon receipt of the CHF 150 million option exercise milestone from Novartis, Molecular Partners now estimates its cash runway to extend well into 2025, excluding any potential royalty income as well as excluding potential further cash flows to or from R&D partners.

Conference call and audio webcastMolecular Partners will hold a conference call and audio webcast on Monday, January 10, 2022, at 7am ET.

To register for the conference call, please dial the following numbers approximately 10 minutes before the start of the presentation:

Switzerland / Europe 0800836508USA (844) 865-3856Conference ID 5090778

Participants in the conference call will have the opportunity to ask questions after a statement from management.

Audio webcastThe call will be webcast live and will be madeavailableon the Companys website under the investor section. The replay will be available for 90 days following the presentation. Webcast participants will have the opportunity to ask questions via chat.

AboutensovibepEnsovibep is a DARPin therapeutic candidate, designed specifically to inactivate SARS-CoV-2, the virus that causes COVID-19. DARPins(Designed Ankyrin Repeat Proteins)are mono- or multi-specific protein-based therapies, designed to specifically engage their targets for various effects. Ensovibep was designed to include three individual DARPin domains, each highly neutralizing to SARS-CoV-2. With these domains constructed into a single molecule, ensovibep can block the receptor-binding domain (RBD) of the SARS-CoV-2 spike protein through highly potent and cooperative binding. This design ensures strong neutralization, even in the presence of mutations of the spike protein and limits the development of escape mutants. Several characteristics ofDARPintherapeutics make them suitable for COVID-19 treatment, includingmulti-specific binding,the rapid onset of action,andscalablebacterialproduction.

In vitro testing has shown high neutralization activity ofensovibepagainst allknown SARS-CoV-2variants, including thevariants of concern:Alpha, Beta, Gamma,Deltaand Omicron.3

About the EMPATHY clinicaltrialprogram2Following promising Phase 1 clinical data for ensovibep the global EMPATHYclinicaltrialwas initiated byNovartis, with Molecular Partners as sponsor,in May 2021. EMPATHY is aPhase 2 and 3 studylooking atthe safety and efficacy of ensovibep in symptomatic COVID-19 patients in the ambulatory (non-hospitalized) setting.Ensovibep is administered via a single dose IV infusion.

The EMPATHY clinical trialplans to enroll 2,100 patients.407 patients were randomized into four arms ofPart Aof thestudyto identify a dose with optimal safety and efficacy.The clinical efficacy and safety of this dose vs. placebo will be further evaluated in Part B, the Phase 3 component of the EMPATHYstudy which willenroll an additional1,700 patientsglobally.

The EMPATHY clinical trialenrolled both vaccinated and unvaccinatedadult patients whohave experienced at least two mild/ moderate symptoms of COVID-19 within seven days of onset andhada positive rapid antigen test on the day of dosing, confirmed by a PCR testat baseline.The COVID-19 symptoms include fever, cough, sore throat, low energy, tiredness, headache, muscle or body aches, chills and/ or shortness of breath.

About Molecular Partners AGMolecular 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 oncology, infectious disease, and ophthalmology, and has compounds in various stages of clinical and preclinical development across multiple therapeutic areas.www.molecularpartners.com; Find us on Twitter -@MolecularPrtnrs

References

-- https://clinicaltrials.gov/ct2/show/NCT04828161?term=ensovibep&draw=2&rank=2 -- Data on file, Molecular Partners, 2021. -- https://www.biorxiv.org/content/10.1101/2021.02.03.429164v3

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, including expectations regarding timing of clinical trials or the potential therapeutic and clinical benefits of Molecular Partners product candidates. 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 AGs 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 our expectations include our reliance on third party partners and collaborators over which we may not always have full control; our plans to develop and potentially commercialize our product candidates; our ongoing and planned clinical trials and preclinical studies for our product candidates, including the timing of such trials and studies; the timing of and our ability to obtain and maintain regulatory approvals for our product candidates; our commercialization, marketing and manufacturing capabilities and strategy; our ability to identify and in-license additional product candidates; the extent of clinical trials potentially required for our product candidates; the clinical utility and ability to achieve market acceptance of our product candidates; our intellectual property position; and other risks and uncertainties that are described in the Risk Factors section of Molecular Partners Registration Statement on Form F-1 filed with Securities and Exchange Commission (SEC) on June 14, 2021 and other filings Molecular Partners makes with the SEC. These documents are available on the Investors page of Molecular Partners website at http://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.

For further details, please contact:Seth Lewisseth.lewis@molecularpartners.comTel: +1 781 420 2361

Shai Biran, Ph.D.shai.biran@molecularpartners.comTel: +1 978 254 6286

Thomas Schneckenburger, European IR & Mediathomas.schneckenburger@molecularpartners.comTel: +41 79 407 9952