Aridis Pharmaceuticals continuing to explore ‘multiple paths to monetize’ assets

Aridis Pharmaceuticals (ARDS) announced a corporate update on recent developments. The company said, “The Company continues to diligently explore multiple paths to monetize its assets amidst a protracted challenging capital market and limited internal resources. During the second half of this year it has been in discussions with other pharmaceutical companies and investment firms on possible partnerships and investments in the clinical product candidates AR-301, AR-320, AR-501, and the APEX platform technology. The Company has substantially reduced its operational cash burn by delaying the expenses associated with SEC filings in favor of business development discussions with potential partners and investors. As a result of voluntary non-compliance, the Company was transitioned to and expects to continue to be listed on the OTC Expert Market until a positive outcome from the business development effort on one or more of its programs. Importantly, two promising developments have been achieved involving the lead assets AR-301 and AR-501 that, if realized, are expected to generate near term revenues and shareholder value: The Company recently executed an Asset Acquisition Terms Agreement with an undisclosed pharmaceutical company to assign exclusive ownership of AR-501 upon receiving the Partner’s payments totaling $6,500,000. Two payments of $3,250,000 each are expected to be received in the first and second quarter of 2025, respectively. The Partner is further obligated to make annual royalty payments to Aridis of 12% to 15% of the net sales revenue for up to 10 years following the first commercial sale. Development status: AR-501 is being developed as a therapeutic treatment for chronic bacterial lung infections in cystic fibrosis patients. A Phase 1 trial in healthy adults and a Phase 2a trial in cystic fibrosis patients have been completed. The primary endpoint of safety was achieved in both studies, showing that AR-501 was well tolerated when administered as an inhaled dosage form over several weekly treatments. The pharmacokinetic data showed effective delivery of AR-501 into the lungs of CF patients and a fast clearance rate. The positive clinical trial data also facilitated the filing for non-dilutive grant funding support from governmental sources and non-governmental organizations , which we intend to explore. The discussions with potential partners and investors to continue the development of AR-301 resulted in an investment proposal from a globally recognized private investment firm in an amount that the Company believes is sufficient to complete the second and final Phase 3 study and product approval. The Company is working closely with the investment firm to satisfy specific requirements for the closing of investment. Details of the investment proposal and the progress toward investment closing are expected to be disclosed in 1Q25. Development status: AR-301 is being evaluated for the adjunctive therapeutic treatment of Ventilator Associated Pneumonia. The first of two planned Phase 3 clinical trials saw significant reduction in patient enrollment that was brought about by the COVID-19 pandemic, resulting in an under-powered study. However, despite a small sample size, a positive efficacy trend in favor of AR-301 in VAP patients was observed. Remarkably, in a prespecified subpopulation of adults 65 years and older, the efficacy signal was increased by approximately 300%, reaching statistical significance level. Furthermore, AR-301 treated patients had a median reduction of length of stay in the intensive care unit and hospital by 7 days and by 9 days in the over 65 subpopulation. The clinical data and the proposed design for the second and final Phase 3 study were presented to the FDA and the European Medicines Agency. Concurrence has been achieved with the regulators on a single, globally harmonized Phase 3 study for licensure. Moving the final Phase 3 study forward is predicated on finalizing the above proposed investment. Following a lengthy effort to resolve the product licensing dispute with MedImmune, a mutually satisfactory resolution has not been reached. The Company is currently exploring its legal options for loss recovery. Development status: AR-320 is being developed for the prevention of Ventilator Associated Pneumonia in a pivotal Phase 3 clinical trial. The AR-320-003 Phase 3 clinical study was initiated in 2022, with 24 patients enrolled. The study was placed on voluntary hold at the time that the product license dispute with MedImmune arose, and is now expected to be discontinued. The Company’s primary focus in the past year has been on business development discussions related to its clinical product candidates, on laboratory activities to support two NIH active grant awards and on one funded external collaboration related to the APEX platform technology. Operating expenses, including clinical trial and clinical supplies manufacturing have been substantially lowered while all clinical trials have either been completed or terminated. The Company has been working with its lead lender Streeterville Capital to service the loan. The Company’s near-term goals will be to successfully complete the business objectives described above and to become current on its SEC filings in the first half of 2025.”