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Aridis Pharmaceuticals, Inc. (NASDAQ: ARDS) is a biopharmaceutical company based in Los Gatos, California, focused on developing innovative anti-infective therapies for life-threatening infections. The company leverages its proprietary ʎPEX™ and MabIgX® technology platforms to identify potent B-cells from patients who have successfully overcome infections and rapidly manufacture monoclonal antibodies (mAbs) for therapeutic use. These mAbs are already of human origin and do not require further engineering optimization to achieve full functionality.
Aridis is advancing multiple clinical-stage mAbs targeting bacteria and viruses that cause severe infections such as ventilator-associated pneumonia (VAP) and hospital-acquired pneumonia (HAP). The company’s novel approach addresses the limitations of current broad-spectrum antibiotics, such as increasing drug resistance, short duration of efficacy, and disruption of the human microbiome.
Highlighted in Aridis' pipeline are seven key products:
- AR-301 (VAP/HAP/CAP): A fully human IgG1 mAb targeting Staphylococcus aureus alpha-toxin, currently in Phase 3 clinical development.
- AR-320 (VAP): A fully human mAb for the prevention of VAP caused by S. aureus, in Phase 3 clinical development.
- AR-501 (Cystic Fibrosis): An inhaled formulation of gallium citrate to treat chronic lung infections in cystic fibrosis patients, in Phase 2a clinical study.
- AR-701 (COVID-19): A cocktail of fully human mAbs targeting SARS-CoV-2 spike proteins.
- AR-101 (HAP): A fully human IgM mAb in Phase 2 clinical development targeting Pseudomonas aeruginosa liposaccharides serotype O11.
- AR-201 (RSV Infection): A fully human IgG1 mAb directed against the F-protein of respiratory syncytial virus (RSV), licensed to the Serum Institute of India.
- AR-401 (Blood Stream Infections): A preclinical mAb program targeting gram-negative Acinetobacter baumannii.
Aridis has recently achieved significant milestones including positive Phase 2a results for AR-501, FDA and EMA agreement on AR-301 Phase 3 study design, and multiple grants from the National Institute of Allergy and Infectious Diseases (NIAID). The company continues to explore strategic partnerships to advance its clinical programs and maximize value for shareholders.
Aridis Pharmaceuticals (Nasdaq: ARDS) reported Q3 2021 results, noting significant advancements in its clinical pipeline. The company in-licensed suvratoxumab (AR-320) from AstraZeneca, with a Phase 3 study set to launch in early 2022. Positive Phase 2 data indicated a 32% relative risk reduction in pneumonia. Financially, cash was approximately $18.2 million, with revenues of $0.4 million driven by a milestone payment for AR-501. However, R&D expenses surged to $19.8 million, primarily due to the AR-320 license agreement, resulting in a net loss of approximately $21.0 million.
Aridis Pharmaceuticals (Nasdaq: ARDS) reported Q2 2021 results, highlighting a licensing agreement with AstraZeneca for suvratoxumab, a monoclonal antibody candidate for pneumonia prevention. The Phase 3 study is set to launch in Q4 2021, supported by €25 million from the EU. Phase 2 results showed a 32% pneumonia risk reduction overall and 47% in patients under 65. The company raised $25 million through a stock sale for clinical development and operations. Despite an increase in R&D and administrative expenses, the net loss rose to $5.5 million, surpassing Q2 2020's loss of $4.2 million.
Aridis Pharmaceuticals (Nasdaq: ARDS) announced a definitive agreement with a healthcare-focused institutional investor to sell 4,947,556 shares and warrants to purchase up to 2,473,778 additional shares at an effective price of $5.053 per share. This registered direct offering, set to close on August 4, 2021, is expected to generate approximately $25 million in gross proceeds. The proceeds will fund clinical development, working capital, and general corporate purposes. H.C. Wainwright & Co. is the exclusive placement agent for this offering.
Aridis Pharmaceuticals (Nasdaq: ARDS) has secured an exclusive worldwide license from AstraZeneca (LSE/STO/Nasdaq: AZN) for suvratoxumab, a monoclonal antibody candidate aimed at preventing pneumonia. This Phase 3-ready candidate follows positive Phase 2 results, showing a 47% reduction in pneumonia among S. aureus-colonized mechanically ventilated patients. Aridis will receive up to €25 million (~$30 million) in funding from the EU for the Phase 3 trial, while AstraZeneca will obtain an $11 million upfront payment and potential milestones worth $115 million.
Aridis Pharmaceuticals, Inc. (Nasdaq: ARDS) announced that its COVID-19 monoclonal antibody (mAb) cocktail AR-712 effectively neutralizes the Delta variant of SARS-CoV-2 at a concentration of ~20ng/mL. Binding analyses indicate AR-712's efficacy against all variants of concern by CDC. The inhaled treatment, showing strong results in preclinical studies with a 1mg/kg dose, aims to lower treatment barriers for non-hospitalized patients. The company is progressing toward commencing clinical studies in late 2021, reinforcing its commitment to combat COVID-19.
Aridis Pharmaceuticals, Inc. (Nasdaq: ARDS) reported Q1 2021 results, highlighting the addition of a second inhaled monoclonal antibody for COVID-19 treatment. The company anticipates launching a Phase 1/2 study for AR-712 in late 2021 and received developmental support from NIAID. Financially, Aridis ended Q1 with $10.5 million in cash, witnessing a net loss of $7.9 million, a slight increase from $6.5 million in the previous year. R&D expenses grew to $5 million, largely due to COVID-19 program investments. A $7 million financing was closed in March, bolstering their operational capabilities.
Aridis Pharmaceuticals (Nasdaq: ARDS) reported its Q4 2020 results, highlighting several milestones. The company announced positive preclinical data for AR-711, a monoclonal antibody treatment for mild-to-moderate COVID-19 patients, with clinical trials set for 2H 2021. The FDA has streamlined AR-501's Phase 2 trial for cystic fibrosis. Financially, the company reported a net loss of $5.8 million in Q4, an improvement from the previous year. Aridis successfully raised approximately $8.5 million in funding to support ongoing clinical trials.
Aridis Pharmaceuticals, Inc. (Nasdaq: ARDS) announced that CEO Vu Truong will be interviewed on The RedChip Money Report on Bloomberg Network on March 27, 2021, at 7 p.m. local time. The discussion will focus on the company's progress in developing novel anti-infective therapies for serious infections. Aridis utilizes advanced technology platforms to create potent monoclonal antibodies for various infections, including ventilator-associated pneumonia. The interview will provide insights into upcoming milestones and the company's commitment to innovative therapies in the biopharmaceutical space.
Aridis Pharmaceuticals (Nasdaq: ARDS) announced a new out-licensing and product discovery agreement with Kermode Biotechnologies focused on zoonotic viruses. Kermode will finance product candidate discovery for African Swine Fever Virus (ASFV) utilizing Aridis' APEX platform. Under this collaboration, Kermode retains exclusive rights for veterinary mAbs and vaccines, while Aridis keeps exclusive rights for human-use products. The partnership aims to enhance the discovery of therapeutic solutions to mitigate the impact of ASFV and other viruses that could pose a pandemic risk.
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