Yu He (Arthur)

Arthur He of H.C. Wainwright & Co., LLC inquired about the baseline characteristics between CD47 high and low patient groups and asked if there was patient biopsy data showing CD47 upregulation after Enhertu treatment.

Answer

CEO Jason Lettmann stated that baseline characteristics were generally well-balanced and will be detailed at an upcoming medical meeting. CMO Alan Sandler noted that while they don't have specific patient data on post-Enhertu treatment, existing literature suggests CD47 expression increases with subsequent lines of therapy, which supports their trial's rationale.

Arthur He from H.C. Wainwright & Co. asked for clarification on the biologic-experienced patient cohort for the planned pivotal study, specifically whether it would focus on patients who failed Dupixent or include a broader basket of prior therapies.

Answer

Chief Research & Development Officer Jonathan Zalevsky clarified that the biologic-experienced cohort would be broad. By the time the Phase III study begins, this population would primarily consist of patients who have not responded adequately to the IL-4/IL-13 class (e.g., Dupixent, lebrikizumab, Adbri) and potentially IL-31 antagonists. He noted that while the OX40 class may be approved, it would not yet represent a significant portion of the experienced patient pool.

Arthur He from H.C. Wainwright & Co., LLC asked if Aurinia plans to present detailed data from the Aratinircept (AUR-200) single ascending dose study at a medical conference. He also inquired about the circumstances under which the company would disclose the specific indications being pursued for the asset.

Answer

Chief Medical Officer Dr. Greg Keenan confirmed the data will be presented at a future, yet-to-be-determined medical meeting. President and CEO Peter Greenleaf added that the latest the target indications would be disclosed is when the information becomes public on clinicaltrials.gov, reiterating that the details are currently being withheld for competitive reasons.

Arthur He asked about plans to present detailed data from the Aratinacept SAD study at a medical conference and under what circumstances the company would disclose the drug's target indications.

Answer

Chief Medical Officer Dr. Greg Keenan confirmed the SAD study data will be presented at a future, yet-to-be-determined medical meeting. President and CEO Peter Greenleaf explained that target indications will become public information upon listing on clinicaltrials.gov, but the company is withholding details until then for competitive reasons.

Arthur He asked if Aurinia plans to present detailed data from the Aratinacept single ascending dose study at a medical conference and under what circumstances the company would disclose the specific indications being pursued for the drug.

Answer

Chief Medical Officer Dr. Greg Keenan confirmed the data will be presented at a future, yet-to-be-determined meeting. President and CEO Peter Greenleaf added that the latest the indications would be disclosed is when they become public on clinicaltrials.gov, reiterating that the information is currently being withheld for competitive reasons.