Aridis Pharmaceuticals, Inc. (OTC: ARDS) announced significant developments regarding its clinical product candidates, AR-301, AR-320, and AR-501, alongside its APEX platform technology. The company is actively pursuing multiple avenues to monetize its assets amidst challenging capital markets.
AR-501 Asset Acquisition
Aridis has entered an Asset Acquisition Terms Agreement with an undisclosed pharmaceutical company for AR-501, a Phase 2 product candidate. The agreement stipulates that Aridis will receive $6.5 million in payments in exchange for exclusive ownership of AR-501. The payments are structured as two installments of $3,250,000, expected in the first and second quarters of 2025, respectively. Furthermore, Aridis is entitled to annual royalty payments ranging from 12% to 15% of net sales revenue for up to 10 years following the first commercial sale.
AR-501 is being developed as a therapeutic intervention for chronic bacterial lung infections in cystic fibrosis (CF) patients. Clinical development includes successful completion of a Phase 1 trial in healthy adults and a Phase 2a trial in CF patients, where the primary endpoint of safety was met, demonstrating that AR-501 was well tolerated via inhalation over several weekly treatments. Pharmacokinetic data indicated effective drug delivery into the lungs of CF patients with a fast clearance rate.
AR-301 Investment Proposal
Discussions with potential partners and investors regarding AR-301 have resulted in an investment proposal from a globally recognized private investment firm. The proposed investment is deemed sufficient by Aridis to complete the second and final Phase 3 study and pursue product approval. The company is collaborating with the investment firm to meet specific requirements for closing the investment, with further details expected to be disclosed in Q1 2025.
AR-301 is under evaluation as an adjunctive therapeutic treatment for Ventilator Associated Pneumonia (VAP). The initial Phase 3 clinical trial faced reduced patient enrollment due to the COVID-19 pandemic, leading to an under-powered study. Despite the small sample size, a positive efficacy trend was observed in favor of AR-301 in VAP patients (p=0.242 at day 21). Notably, in a pre-specified subpopulation of adults aged 65 and older, the efficacy signal increased by approximately 300%, reaching statistical significance (p=0.056 at day 21 and p=0.025 at day 28 post-treatment). AR-301 treatment also correlated with a median reduction in ICU and hospital length of stay by 7 days and 9 days, respectively, in the over-65 subpopulation. Aridis has presented the clinical data and the proposed design for the second Phase 3 study to both the FDA and the European Medicines Agency (EMA), achieving concurrence on a single, globally harmonized Phase 3 study for licensure.
AR-320 Development Discontinuation
Efforts to resolve a product licensing dispute with MedImmune Limited, a subsidiary of AstraZeneca, regarding AR-320 have been unsuccessful. Aridis is currently exploring legal options for loss recovery. The AR-320-003 Phase 3 clinical study, initiated in 2022 with 24 patients enrolled, was placed on voluntary hold due to the licensing dispute and is now expected to be discontinued.
Company Operations
Aridis Pharmaceuticals has focused on business development discussions, laboratory activities supporting NIH grant awards, and an external collaboration related to the APEX platform technology. Operating expenses have been substantially reduced, and the company is working with its lead lender, Streeterville Capital, LLC, to service its loan. Aridis aims to complete its business objectives and become current on its SEC filings in the first half of 2025.
