Aridis Provides Corporate Update

LOS GATOS, Calif., March 31, 2023 (GLOBE NEWSWIRE) -- Aridis Pharmaceuticals, Inc. (Nasdaq: ARDS) (“Aridis” or the “Company”), a biopharmaceutical company, today announced a corporate update on recent developments.

The Company received written notice from MedImmune Limited (“MedImmune”) terminating a certain license covering AR-320, a product candidate currently being evaluated for the prevention of Ventilator Acquired Pneumonia (VAP) in a Phase 3 clinical trial, between the companies (“License Agreement”), dated July 12, 2021 and amended August 9, 2021, due to a license payment matter. Based on the failure of MedImmune to assist in the necessary technology transfer pursuant to Section 3.5.2 of the License Agreement, the Company notified MedImmune on March 24, 2023 that it was in material breach of Section 3.5.2 and requested that the material breach be cured as soon as possible. As a result of this sudden, unexpected termination, Aridis has placed its AR-320-003 Phase 3 clinical study on hold.

“While we seek a remedy to the license dispute, we want to assure our shareholders that we remain steadfastly committed to developing our pipeline products as potential breakthrough therapies to fight antimicrobial resistance,” said Aridis’ CEO Vu Truong, PhD.

The Company’s operating expenses have been significantly lowered with the AR-320-003 trial on hold, and it has reduced its full-time employee headcount by seven and now has 26 full-time employees.

With positive trends in the data from the Company’s Phase 3 study of AR-301 in VAP and its Phase 2a study of AR-501 in cystic fibrosis (CF), Aridis remains focused on advancing the continued development of these programs.

“The potential for AR-301 to provide pharmacoeconomic benefits and to fulfill an unmet need in high-risk, vulnerable patient populations is driving interest from possible pharmaceutical partners,” added Dr. Truong. “We believe the consistency of clinical efficacy trends and the magnitude of clinical response associated with AR-301 treatment bode well for continued development, and we are moving forward with preparations for the planned second Phase 3 study of AR-301 to build value for our shareholders.”

The Company expects to receive feedback from both the FDA and EMA on the second Phase 3 study design for AR-301 by the end of April 2023.

The dosing of the first six CF patients of the highest dose cohort (80mg) in the Company’s Phase 2a study of AR-501 is now complete. Safety data from this cohort will be reviewed and discussed with the Cystic Fibrosis Foundation to explore additional potential development collaborations.