Aridis Pharmaceuticals Announces 2020 4th Quarter and Year-End Financial Results and Business Update.

LOS GATOS, Calif: Aridis Pharmaceuticals, Inc. (Nasdaq: ARDS), a biopharmaceutical company focused on the discovery and development of novel anti-infective therapies to treat life-threatening infections, today reported financial and corporate results for the fourth quarter ended December 31, 2020.

Fourth Quarter Highlights and Recent Developments

Announced positive preclinical efficacy data for AR-711, a potential inhaled, self-administered, at-home monoclonal antibody treatment ("mAb") for non-hospitalized mild-to-moderate COVID-19 patients. A clinical Phase 1/2 study is expected to be launched in 2H 2021.

Received concurrence from the U.S. Food and Drug Administration ("FDA") to streamline AR-501's Phase 2 clinical trial design and to expand the originally planned Phase 2a protocol design into a Phase 2a/2b study for treating chronic lung infections in patients with cystic fibrosis (CF). Enrollment completion is expected in late 2021.

Continued enrolling global Phase 3 clinical trial of AR-301 in patients with ventilator associated pneumonia (VAP) including patients who presented with S. aureus VAP as a secondary infection to COVID-19. Interim futility analysis is expected in 2H 2021 and top-line data expected in 1H 2022.

Entered into a YPEX out-licensing and product discovery agreement with Kermode Biotechnologies, Inc. on vaccines and mAbs for zoonotic viruses, which are animal viruses that have the ability to infect humans.

Licensed the CRISPR gene editing technology from the Broad Institute of MIT and Harvard. CRISPR is a key component of the APEX mAb discovery and production platform technology.

Executed a Registered Direct offering with gross proceeds of approximately $8.5 million in the fourth quarter and approximately $7.0 million in March 2021.

"During the fourth quarter and over the recent months, we achieved multiple important milestones that impact our clinical and corporate profile, highlighted by the addition of an inhaled at-home COVID-19 treatment (AR-712) to our portfolio of product candidates and entering into an YPEX out-licensing and product discovery agreement with Kermode Biotechnologies for zoonotic viruses," commented Vu Truong, Ph.D., Chief Executive Officer of Aridis Pharmaceuticals. "Additionally, we reached concurrence with the FDA to streamline and thus expedite the clinical and regulatory process for AR-501's Phase 2 program in cystic fibrosis, and bolstered our balance sheet with the $15.5 million financing. These important achievements have helped position us for continued growth as we head into 2021."

COVID-19 Program Update

AR-712: During the quarter, Aridis announced the development of a highly potent fully human mAb against SARS-CoV-2 virus. AR-712 is a cocktail of two mAbs, AR-711 and AR-713, designed to lower the barrier to treatment coverage of non-hospitalized COVID-19 patients by using a convenient, self-administered inhaled dosage presentation. The two mAbs that comprise AR-712 were discovered from convalescent COVID-19 patients and target the receptor-binding domain (RBD) region of the spike protein of the original SARS-CoV2 virus and its newly emerging variants including the currently prevalent strain 'E484K' associated with the South Africa, Brazil, and Japan variants.

In an animal challenge study with golden Syrian hamsters, inhaled AR-711 successfully eliminated all detectable SARS-CoV-2 virus at substantially lower doses than...