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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) announced the enhancement of its inhaled COVID-19 treatment, adding a second monoclonal antibody, AR-713, to its existing AR-711. This dual therapy aims to neutralize emerging variants from South Africa, Brazil, and Japan. Preclinical development support is provided by NIAID and the Coronavirus Immunotherapy Consortium. The company plans to initiate Phase 1/2/3 clinical trials in the second half of 2021, targeting non-hospitalized COVID-19 patients, potentially easing hospital burdens.
Aridis Pharmaceuticals (Nasdaq: ARDS) will host a 75-minute Fireside Chat Forum on December 4, 2020, at 11:00 AM EST, featuring its five covering analysts. The event aims to provide insights into the company's 2021 plans, including updates on its lead clinical programs and COVID-19 mAb initiatives. Analysts will discuss key assets like AR-301 for ventilator-associated pneumonia and AR-501 for cystic fibrosis. ʎPEX™ technology, aimed at discovering novel antibodies, will also be highlighted.
Aridis Pharmaceuticals, Inc. (Nasdaq: ARDS) reported its financial results for Q3 2020, highlighting significant developments in its COVID-19 treatment pipeline. Key achievements included positive preclinical data for AR-711, a self-administered inhaled monoclonal antibody, with a Phase 1/2 study expected in 1H 2021. The FDA approved a streamlined Phase 2/2b clinical trial design for AR-501 targeting cystic fibrosis. The company raised approximately $8.5 million through a direct offering, bolstering its financial position. The net loss for Q3 2020 was approximately $5.8 million, a decrease from $7.6 million in Q3 2019.
Aridis Pharmaceuticals (Nasdaq: ARDS) will present at the ROTH Capital Partners 2020 MedTech Innovation Forum on October 28, 2020. Dr. Hasan Jafri, the Chief Medical Officer, will discuss the company's inhaled monoclonal antibody, AR-711, which targets SARS-CoV-2. AR-711 shows a high affinity for the virus's spike protein and has demonstrated efficacy in both prophylactic and therapeutic uses. The drug is intended for non-hospitalized patients with mild to moderate COVID-19. Aridis is developing several mAbs and small molecules aimed at addressing critical infections.
Aridis Pharmaceuticals (Nasdaq: ARDS) announced the successful development of AR-711, a monoclonal antibody that effectively eliminates SARS-CoV-2 in infected animals at low doses. This inhaled treatment targets the lung directly, offering advantages over traditional intravenous mAbs. Key findings included efficacy demonstrated with a minimal dose of 0.03 mg/kg and a potential therapeutic dose for humans estimated at 2 to 6 mg. The company plans to launch a global study for AR-711 in non-hospitalized COVID-19 patients in mid-2021, aiming to improve treatment access and reduce healthcare costs.
Aridis Pharmaceuticals, Inc. has announced a securities purchase agreement with institutional investors for a registered direct offering of 1,134,470 shares at $7.4925 each, raising approximately $8.5 million. Concurrently, investors will purchase warrants for 567,234 shares, with Series A warrants priced at $7.43 and Series B at $9.00. The funds will primarily support ongoing clinical trials, especially the Phase 3 trial for AR-301 targeting ventilator-associated pneumonia, AR-501 for cystic fibrosis lung infections, and further COVID-19 therapies.
Aridis Pharmaceuticals (Nasdaq: ARDS) has reached an agreement with the FDA to simplify the Phase 2 trial design for AR-501, aimed at treating chronic lung infections in cystic fibrosis patients. Following positive Phase 1 safety data, the FDA has approved a streamlined design that eliminates the single ascending dose (SAD) approach and combines the Phase 2a and 2b trials into one. This adaptive design is expected to expedite the clinical trial process, with the Phase 2a trial anticipated to start soon and conclude by late 2021.
Aridis Pharmaceuticals, Inc. (Nasdaq: ARDS) announced CEO Vu Truong will present at two investor conferences on September 15, 2020. The Cantor Fitzgerald Virtual Global Healthcare Conference is scheduled for 9:20 AM EDT, followed by the H.C. Wainwright 22nd Annual Global Investment Conference at 3:30 PM EDT. A webcast of the Cantor Fitzgerald presentation will be available for 90 days post-event. Aridis focuses on developing innovative anti-infective therapies, leveraging proprietary technologies to combat life-threatening infections.
Aridis Pharmaceuticals (Nasdaq: ARDS) reported its second quarter 2020 financial results, highlighting significant advancements in clinical trials. The company announced positive safety data from the Phase 1 portion of its AR-501 trial for cystic fibrosis, with Phase 2 results expected in 2021. Additionally, it continues its Phase 3 trial for AR-301 in ventilator-associated pneumonia, with interim data anticipated in late 2020. The company's cash total reached $11.8 million, and it received a $715,000 Paycheck Protection Program loan. The net loss shrank to $4.2 million, compared to $8.4 million in the same period last year.
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