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$Aridis制药(ARDS)$ 8-K Current report, items 2.02 and 9.01 Accession Number: 0001104659-22-041492  Act: 34  Size: 283 KB 网页链接

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2022-04-01 22:14

不错不错,希望加快进度!

2022-04-01 21:20

Fourth Quarter Highlights

·Continued enrollment in the Company’s Phase 2a study of AR-501 targeting cystic fibrosis (CF), conducted in collaboration with the funding support from the CF Foundation. Aridis is on track to report top-line data from this CF study in mid-2022.·Continued enrollment in the Company’s Phase 3 study evaluating AR-301 for the treatment of Ventilator Associated Pneumonia (VAP). Aridis is on track to report top-line data in the second half of 2022.·The Company is on track to initiate the Phase 3 trial of AR-320 for the prevention of VAP in mid-2022 following regulatory feedback on the clinical development plans and Phase 3 study design received from the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA). Clarity on the regulatory pathway to the registrational Phase 3 trial and licensure has been achieved. The Phase 3 SAATELLITE-2 study will be conducted in collaboration with the COMBACTE-Net consortium of HAP/VAP experts, funded up to 25 million Euros by the Innovative Medicines Initiative (IMI) program of the European Commission.·Reported preclinical data demonstrating that AR-701, the Company’s first fully human monoclonal antibody (mAb) cocktail, is broadly reactive against the Omicron and other SARS-CoV-2 (COVID-19) variants, SARS (Severe Acute Respiratory Syndrome), MERS (Middle East Respiratory Syndrome Coronavirus), and multiple seasonal ('common cold') human coronavirus strains.·In January 2022, Aridis announced that it had received a $1.9 million grant from the Bill and Melinda Gates Foundation (Gates Foundation) to evaluate the application of the Company's inhaled formulation technology to deliver cost-effective monoclonal antibodies (mAbs) against influenza and SARS-CoV-2 to people in low- and middle-income countries.·Signed loan agreement for $10 million in non-dilutive financing with Streeterville Capital. Received first $5 million payment in November 2021 and the second $5 million payment in February 2022.“I am proud of our team’s work in 2021 as we strengthened our foundation and advanced key development programs,” commented Vu Truong, Ph.D., Chief Executive Officer of Aridis Pharmaceuticals. “2022 will be a pivotal year for Aridis as we achieve important clinical milestones, including data readout from our AR-501 Phase 2a and AR-301 Phase 3 studies as well as the initiation of the AR-320 registrational Phase 3 study, and the anticipated launch of the first-in-human clinical study of AR-701. We look forward to sharing further updates on the progress of these programs in the coming months as we continue to build our leadership in the respiratory health space.”