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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 a conference call on January 25, 2023, at 4:15 p.m. ET to discuss a business and pipeline update, which will include topline data from its Phase 3 study of AR-301 for treating S. aureus ventilator-associated pneumonia (VAP). The company expects to release this data prior to the call. AR-301 is part of a broader pipeline of novel anti-infective therapies targeting severe infections. Additionally, a question-and-answer session will follow the presentation to address inquiries from investors and stakeholders.
Aridis Pharmaceuticals (NASDAQ: ARDS) announced a $4.85 million investment from the Cystic Fibrosis Foundation to support the development of AR-501, an inhalable anti-infective for cystic fibrosis patients. This brings total funding from the CF Foundation to $12.5 million. Enrollment for the Phase 2a study was completed in November 2022, with top-line results expected in Q1 2023. AR-501 has received Orphan Drug Designation and Fast Track status from the FDA, indicating its potential significance in treating chronic lung infections.
Aridis Pharmaceuticals (NASDAQ: ARDS) announced a $4.85 million investment from the Cystic Fibrosis Foundation to support the ongoing development of AR-501, an inhalable anti-infective targeting chronic lung infections in cystic fibrosis patients. This funding raises the Foundation's total investment to $12.5 million. Enrollment for AR-501's Phase 2a study concluded in November 2022, with top-line results expected in Q1 2023. AR-501 has received Orphan Drug and Fast Track designations from the FDA, indicating its potential significance in treating this patient population.
Aridis Pharmaceuticals, Inc. (NASDAQ: ARDS) has secured approximately $190 million in BARDA funding to advance its pan-Ebola and pan-Marburg monoclonal antibody (mAb) programs. The funding covers manufacturing, efficacy and safety evaluations, and regulatory approval processes. Aridis has also signed an exclusive term sheet with Mapp Biopharmaceutical, Inc. for global commercial rights upon licensure. Both mAb candidates are in Phase 1 clinical trials and have shown promising results against lethal virus challenges in non-human primates, enhancing U.S. public health preparedness.
Aridis Pharmaceuticals (NASDAQ: ARDS) has successfully completed patient enrollment for its Phase 2a clinical trial of AR-501, an inhalable anti-infective treatment for cystic fibrosis (CF). A total of 39 patients from 24 clinical centers participated in the trial, which tested three multiple ascending doses and a dose-ranging cohort. The company expects to lock the database and report top-line results in Q1 2023. AR-501 holds several FDA designations, including Orphan Drug and Fast Track, aimed at addressing chronic lung infections associated with CF.
Aridis Pharmaceuticals will participate in H.C. Wainwright & Co.’s 2022 KOL Series on November 29, 2022, focusing on its Phase 3 ‘ASAP-1’ study of AR-301, a monoclonal antibody targeting S. aureus pneumonia. The event will feature expert Professor Bruno Francois, highlighting the comparative effectiveness of AR-301 combined with antibiotics against standard antibiotics alone. The study aims to address ventilator-associated pneumonia (VAP) caused by S. aureus. Aridis is committed to advancing novel anti-infective therapies as critical treatments for life-threatening infections.
Aridis Pharmaceuticals (NASDAQ: ARDS) has announced the closure of patient enrollment in its AR-301 Phase 3 clinical study, aimed at evaluating the investigational immunotherapy AR-301 for treating ventilator-associated pneumonia (VAP) caused by Staphylococcus aureus. The company expects to report top-line data by December 2022. This global study, involving 153 sites across 20 countries, is noteworthy for being the first Phase 3 study assessing a human monoclonal antibody in this indication. The independent Data Safety Monitoring Committee has not reported any safety concerns, maintaining the study's integrity.
Aridis Pharmaceuticals, Inc. (Nasdaq: ARDS) has withdrawn its proposed public offering of common stock due to unfavorable market conditions. CEO Vu Truong emphasized that this decision aims to secure the best value for stockholders while focusing on the company's clinical development plans. Aridis is advancing multiple monoclonal antibody (mAb) programs for life-threatening infections and utilizing its proprietary technology platforms to enhance the efficiency of its therapies. The company remains dedicated to its innovative approaches in anti-infective treatments.
Aridis Pharmaceuticals, Inc. (Nasdaq: ARDS) announced its intention to offer common stock in a public offering to fund clinical development and general corporate purposes. The offering will depend on market conditions, with no assurance on completion or terms. Aegis Capital Corp. is the sole book-running manager. This offering is made under an effective shelf registration statement filed with the SEC. Aridis focuses on anti-infective therapies for life-threatening infections utilizing novel technology platforms, advancing multiple monoclonal antibody candidates in clinical trials.
Aridis Pharmaceuticals (Nasdaq: ARDS) reported financial results for Q2 2022, revealing a net loss of approximately $8 million, equating to a $0.45 loss per share. Key developments include ongoing Phase 3 studies for AR-301 and Phase 2a studies for AR-501, with top-line data expected in the latter half of 2022. The company also launched a Phase 3 trial for AR-320, receiving regulatory support. Cash reserves totaled $8 million, while R&D expenses rose to $6.3 million due to increased clinical trial spending. Total revenues, primarily from grants, reached $0.3 million, up from $33,000 in Q2 2021.
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