Panaecin (gallium citrate) / Aridis - LARVOL DELTA

Antibiotics and non-traditional antimicrobial agents for pseudomonas aeruginosa in clinical phases 1, 2, and 3 trials. (PubMed, Expert Opin Investig Drugs) - "Traditional agents in clinical development include β-lactam/β-lactamase inhibitors (funobactam, taniborbactam, QPX2014-xeruborbactam), aminoglycosides (apramycin), polymyxin derivatives (upleganan, MRX-8, and SPR741), fluoroquinolones (MP-376), and lipopolysaccharide transport inhibitors (murepavadin). Non-traditional antibiotics in clinical development include anti-virulence agents (fluorothiazinone), monoclonal antibodies (INFEX-702, TRL-1068, and CMTX-101), bacteriophages (AP-PA02, YPT-01, BX004-A, and WRAIR-PAM-CF1), and miscellaneous agents (AR-501, PLG-0206, SNSP-113, OligoG CF-5/20, and ALX-009). A considerable number of antimicrobial agents, some with novel mechanisms of action, are in clinical phases of development for treating Pseudomonas aeruginosa infections. The urgent need for more therapeutic options necessitates the rapid optimization of progress to introduce new agents into clinical practice."

Journal • Review • Infectious Disease

A multi-targeted approach to identify sputum and blood inflammatory cell responses to AR-501 as a measure of treatment response in subjects with cystic fibrosis (NACFC 2023) - "In subjects treated with AR-501 who experienced improve-ments in FEV1, a CF leukocyte gene signature identified FEV1 responders’ systemic inflammatory pathways and accurately categorized responders and non-responders. Although sputum biomarkers of response were not identified, probably because of the timing of sample collection and RNA quality, the trial highlights novel molecular approaches to identifying markers in clinical trials in the post-modulator era. Given the pressing need for primary endpoints beyond modest FEV1improvement and sputum microbiology (in subjects unable to produce), molecular markers are an important future strategy for understanding trial drug effects in human subjects."

Clinical • Inflammatory cell • Cystic Fibrosis • Fibrosis • Genetic Disorders • Immunology • Infectious Disease • Inflammation • Pneumonia • Pulmonary Disease • Respiratory Diseases • ADAM9 • CD163 • CD36 • PPIA • TLR2

Aridis Meets Primary and Secondary Endpoints in Phase 2a Study of AR-501 in Cystic Fibrosis Patients (GlobeNewswire) - P1/2a | N=102 | NCT03669614 | Sponsor: Aridis Pharmaceuticals, Inc. | "Aridis Pharmaceuticals...today announced preliminary top-line results from the randomized, double blinded, placebo-controlled Phase 2a study of AR-501, which evaluated the safety and pharmacokinetics of three ascending doses of AR-501 administered as an inhaled aerosol in cystic fibrosis (CF) patients with confirmed Pseudomonas aeruginosa bacterial and other potential infections....Three weekly inhaled doses of AR-501 at 6.4mg, 20mg, and 40mg dose levels were well tolerated in CF patients. No drug related serious adverse events (SAEs) were observed....We look forward to discussing the results from these two programs with the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) to plan the definitive next study for each program to support the filing of a license application....Data from the highest cohort are expected in the second half of 2023."

P2a data • Cystic Fibrosis • Respiratory Diseases

Phase 1/2a randomized, double-blind, placebo-controlled study: safety, Pk, and Efficacy outcome measures of inhaled Gallium Citrate (AR-501) in P Aeruginosa infected Cystic Fibrosis patients (ECFS 2023) - P1/2 | "AR-501 is being developed as a once-weekly aerosolized antimicrobial with broad antimicrobial activity. Inhaled AR-501 has been well tolerated when administered once weekly x3 weeks. Ph2a safety, efficacy and biomarker data readout is due prior to ECFS meeting."

Clinical • P1/2 data • Cystic Fibrosis • Fibrosis • Genetic Disorders • Immunology • Pulmonary Disease • Respiratory Diseases

SAD and MAD of Inhaled AR-501 in Health Adults and P. Aeruginosa Infected Cystic Fibrosis Subjects (clinicaltrials.gov) - P1/2 | N=102 | Recruiting | Sponsor: Aridis Pharmaceuticals, Inc. | Trial completion date: Apr 2022 ➔ Jul 2023 | Trial primary completion date: Apr 2022 ➔ Jul 2023

Trial completion date • Trial primary completion date • Cystic Fibrosis • Fibrosis • Genetic Disorders • Immunology • Pulmonary Disease • Respiratory Diseases

New Approaches to Treating Infections in Cystic Fibrosis Patients - AR 501 Phase 2 Trial Update (GlobeNewswire) - "Aridis Pharmaceuticals...announced its participation in Key Opinion Leader (KOL) event focusing on the anti-infective treatment landscape in cystic fibrosis (CF) and the Company’s Phase 2a trial of AR-501 in CF patients. AR-501 is an inhaled formulation of gallium citrate with broad-spectrum anti-infective activity being developed to treat chronic lung infections in CF patients."

Clinical • Cystic Fibrosis

Aridis Pharmaceuticals Receives Equity Investment from the Cystic Fibrosis Foundation (GlobeNewswire) - "Aridis Pharmaceuticals...a biopharmaceutical company today announced the Cystic Fibrosis Foundation invested $4.85 million in Aridis common stock on market terms under NASDAQ rules to support the ongoing development of AR-501, an inhalable broad-spectrum anti-infective currently under development for controlling debilitating chronic lung infections in cystic fibrosis (CF) patients. Including this funding, the CF Foundation has provided a total of $12.5 million in support. Enrollment for a Phase 2a study of AR-501 in CF patients was completed in November 2022."

Enrollment closed • Financing • Cystic Fibrosis

Aridis Pharmaceuticals Announces Third Quarter 2022 Financial Results and Business Update (GlobeNewswire) - "AR-501 (gallium citrate): The Phase 2a study is actively enrolling patients with the goal of delivering top-line data readout in first quarter of 2023....Based on available blinded safety data of the on-going Phase 2a study, FDA concurred with the Company’s proposal to include an optional higher dose cohort after enrollment of the current dose cohorts....Research and development expenses decreased by approximately $13.7 million, from approximately $19.8 million for the quarter ended September 30, 2021, to approximately $6.1 million for the quarter ended September 30, 2022....These decreases were offset by an increase in spending on clinical trial activities for the Phase 2a study of our AR-501 program and an increase in personnel, consulting and other related costs."

Commercial • P2a data • Cystic Fibrosis

PHASE 1/2a RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY: SAFETY, PK, AND EFFICACY OUTCOME MEASURES OF INHALED GALLIUM CITRATE (AR-501) IN CYSTIC FIBROSIS PATIENTS (NACFC 2022) - P1/2 | "AR-501 is being developed as a once-a-week aerosolizedantimicrobial with low potential for inducing AMR. Inhaled AR-501 inpeople chronically infected with P. aeruginosahas been well tolerated when administered once weekly for 3 weeks. The Phase 2a safety, efficacy, andbiomarker data readout is expected before the 2022 North American CysticFibrosis Conference and will be added to the current placeholder abstractbefore the meeting."

Clinical • P1/2 data • Cystic Fibrosis • Fibrosis • Genetic Disorders • Immunology • Nontuberculous Mycobacterial Disease • Pulmonary Disease • Respiratory Diseases

Aridis Pharmaceuticals Announces Second Quarter 2022 Financial Results and Business Update (PRNewswire) - "Continued enrollment in the Company's Phase 2a study of AR-501 targeting cystic fibrosis (CF), conducted in collaboration with funding support from the Cystic Fibrosis Foundation. Top-line data readout from this CF study is expected in 2H 2022....Research and development expenses increased by approximately $1.8 million from approximately $4.6 million for the quarter ended June 30, 2021 to approximately $6.3 million for the quarter ended June 30, 2022. The increase was primarily due to an increase in spending on clinical trial activities for...AR-501."

Commercial • Enrollment status • P2a data • Cystic Fibrosis

Aridis Pharmaceuticals Announces First Quarter 2022 Financial Results and Business Update (PRNewswire) - "AR-501 (gallium citrate): The Phase 2a study is actively enrolling patients with a goal of delivering full data readout in 2H 2022....Research and Development Expenses...on our ongoing Phase 2a clinical trial evaluating AR-501 for the treatment of cystic fibrosis ($0.1 M)."

Commercial • P2a data • Cystic Fibrosis • Infectious Disease

Sub-acute feeding study of a tall fescue endophyte in a perennial ryegrass host using mice. (PubMed, Toxicon) - "Mice fed AR501 endophyte-infected perennial ryegrass seed remained healthy throughout the experimental period despite consuming 62,000 mg/kg lolines and 4600 mg/kg peramine per day as well as the wide array of other unknown secondary metabolites expressed by this endophyte. Although animal products may contain additional metabolites as a result of animal metabolism, this experiment raises no food safety concerns for AR501 endophyte-infected perennial ryegrass."

Journal • Preclinical • Hematological Disorders

ARIDIS PHARMACEUTICALS, INC. Management's Discussion and Analysis of Financial Condition and Results of Operations (form 10-K) (Market Screener) - "The Safety Monitoring Committee ('SMC') and Data Safety Monitoring Board ('DSMB') from the Cystic Fibrosis Foundation supported that the study proceed at all dose levels to the Phase 2a portion of the Phase 1/2a trial in adult subjects with cystic fibrosis ('CF'). We expect to complete enrollment in mid-2022...the Phase 1/2 study of AR-501 for the treatment of chronic lung infections associated with cystic fibrosis."

DSMB • Enrollment status • Cystic Fibrosis

Aridis Pharmaceuticals Announces 2021 Fourth Quarter and Year-End Financial Results and Business Update (PRNewswire) - "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....Research and Development Expenses...increase of approximately $0.5 million for the continuing conduct of the Phase 2a clinical trial evaluating AR-501 for the treatment of Cystic Fibrosis and an increase of approximately $0.6 million in personnel, consulting and other related costs."

Commercial • Enrollment status • P2a data • Cystic Fibrosis

Aridis Pharmaceuticals CEO Discusses Monoclonal Antibody Cocktail Protection Against COVID-19 Omicron Variant and Other Viruses in Fox Business Interview (PRNewswire) - "AR-501 (cystic fibrosis). AR-501 is an inhaled formulation of gallium citrate with broad-spectrum anti-infective activity being developed to treat chronic lung infections in cystic fibrosis patients. This program is currently in Phase 2a clinical development in CF patients."

Trial status • Cystic Fibrosis

Animal safety of a tall fescue endophyte (Epichloë sp.) in a perennial ryegrass (Lolium perenne) host. (PubMed, N Z Vet J) - "This suggests AR501 tall fescue endophyte does not produce toxic concentrations of secondary metabolites. This study suggests that there are no secondary metabolites produced by the tall fescue AR501 endophyte-perennial ryegrass association which affect animal health or production."

Journal • Infectious Disease • Movement Disorders

Aridis Pharmaceuticals Announces Third Quarter 2021 Results (PRNewswire) - "AR-501: The Company expects to report top-line data from this study during the first half of 2022."

P2a data • Cystic Fibrosis

Exploring the cause of the dual allosteric targeted inhibition attaching to allosteric sites enhancing SHP2 inhibition. (PubMed, Mol Divers) - "Studies have reported that both SHP099 and SHP844 are inhibitors of SHP2 and bind to different allosteric sites 1 and 2, respectively. Meanwhile, residue GLU110 (allosteric site 1), ARG265 (allosteric site 2), and ARG501 (Q-loop) are speculated to be the key residues that causing the SHP2 protein in auto-inhibition conformation. It is hoped that this study will provide clues for the development of the dual allosteric targeted inhibition of SHP2."

Journal • Oncology

Aridis Pharmaceuticals Announces Second Quarter 2021 Results (PRNewswire) - "AR-501: The Company initiated its Phase 2a study to evaluate the safety, pharmacokinetic, and preliminary efficacy evaluation in cystic fibrosis (CF) patients in the first quarter of 2021. The Phase 2a is actively enrolling patients with a goal of 42 cystic fibrosis adult patients at full enrollment. The Company expects to report top-line data from this study during the first quarter of 2022."

Enrollment status • P2a data • Trial status • Cystic Fibrosis

SAD and MAD of Inhaled AR-501 in Health Adults and P. Aeruginosa Infected Cystic Fibrosis Subjects (clinicaltrials.gov) - P1/2; N=90; Recruiting; Sponsor: Aridis Pharmaceuticals, Inc.; Active, not recruiting ➔ Recruiting

Enrollment open • Cystic Fibrosis • Fibrosis • Genetic Disorders • Immunology • Pulmonary Disease • Respiratory Diseases

Aridis Pharmaceuticals Announces 2020 Fourth Quarter and Year-End Financial Results and Business Update (PRNewswire) - "Research and development expenses decreased by approximately $7.1 million from $24.1 million for the year ended December 31, 2019 to $17.0 million for the year ended December 31, 2020. The year over year decrease was primarily due to...decrease in spending on clinical trial activities for the Phase 1/2a study of our AR-501 program because the Phase 1 portion of the study ended in the second quarter of 2020..."

Commercial • Cystic Fibrosis

Aridis Pharmaceuticals Announces 2020 Fourth Quarter and Year-End Financial Results and Business Update (PRNewswire) - "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....The data from the Phase 2a will inform the dose selection and sample size expansion to achieve statistical significance in efficacy in Phase 2b. AR-501...has been granted Orphan Drug Designation (ODD), Fast Track and Qualified Infectious Disease Product (QIDP) designations by the FDA. In addition, the European Medicines Agency (EMA) granted ODD to AR-501....The new Phase 2a/b study design will be available...within the next quarter."

Enrollment status • New P2 trial • Orphan drug • Cystic Fibrosis

Diverse conditions contribute to the cholesterol-lowering ability of different Lactobacillus plantarum strains. (PubMed, Food Funct) - "In MRS broth, L. plantarum AR113 and AR171 showed the greatest cholesterol-lowering abilities of 27.89% and 19.90%, respectively, but AR501 and AR300 only showed reductions of 0.34% and 0.91%, respectively...Taken together, these results suggest that different strains of L. plantarum have different cholesterol-lowering capacities and different influencing factors. Therefore, further research is needed to explore the exact mechanism by which different strains lower cholesterol."

Journal

Aridis Pharmaceuticals Announces $8.5 Million Registered Direct Offering (PRNewswire) - "The Company intends to use the net proceeds from the registered direct offering and concurrent private placement for clinical development of its product candidates, working capital and other general corporate purposes. In the near-term, priority will be placed on the Company's ongoing AR-301 Phase 3 clinical trial for patients with ventilator associated pneumonia (VAP), AR-501's Phase 2b clinical trial for the treatment of chronic lung infections in cystic fibrosis patients, and to continue developing novel COVID-19 therapies."

Financing • Cystic Fibrosis

[VIRTUAL] INTERIM RESULTS OF PHASE 1/2A CLINICAL STUDY OF AR-501, AN INVESTIGATIONAL INHALED FORMULATION OF GALLIUM CITRATE BEING EVALUATED AS AN ANTIBACTERIAL IN CYSTIC FIBROSIS PATIENTS (NACFC 2020) - P1/2 | "The Phase 1 study results of inhaled AR-501 in healthy subjects was generally well tolerated at dosages up to 40 mg Ga by inhalation once weekly (for 5 weeks). Further evaluation of safety and preliminary efficacy in adults with CF infected with P. aeruginosa is scheduled to begin in the second half of 2020."

Clinical • P1/2 data • Cystic Fibrosis • Fibrosis • Genetic Disorders • Immunology • Respiratory Diseases