Andrew Fein

Andrew Fein of Jefferies inquired about the descriptive individual curves from the PALISADE-3 trial, specifically asking if fasedienol showed separation from placebo at any time points up to five minutes. He also questioned the process and risks of modifying the Statistical Analysis Plan (SAP) for PALISADE-4 and whether such changes would necessitate re-evaluating the enrollment target.

Answer

Chief Operating Officer Josh Prince stated that only top-line results for PALISADE-3 have been released, and individual curves are not yet public, with analysis ongoing. He confirmed that any future SAP changes for PALISADE-4 would require resubmission and alignment with the FDA before database lock, but clarified that SAP modifications would not alter the study's planned enrollment target.

Andrew Fein inquired about the detailed descriptive data from the PALISADE-3 trial, specifically asking if individual curves showed separation between fasedienol and placebo at various time points. He also questioned the process and risks associated with modifying the Statistical Analysis Plan (SAP) for PALISADE-4, including whether FDA notification and buy-in would be required, and if such modifications would necessitate changes to the enrollment target.

Answer

Joshua Prince, Chief Operating Officer, stated that only top-line results for PALISADE-3 have been released publicly, and detailed individual curves are still under analysis, though differences are observed in individual and subgroup respondents. Regarding the SAP, Mr. Prince and Shawn K. Singh, President and Chief Executive Officer, confirmed that any future changes to the already approved SAP for PALISADE-4 would require resubmission and alignment with the FDA before database lock. They clarified that a change to the SAP would not alter the planned enrollment target for the study.

Andrew Fein of H.C. Wainwright & Co. asked for takeaways from competitor data at the ADA conference and how it informs the WVE-007 strategy. For WVE-006, he relayed KOL feedback suggesting the importance of reaching ~22 micromolar of AAT and replicating an acute phase response.

Answer

President & CEO Paul Bolno responded that competitor data reinforces the importance of muscle preservation, an area where WVE-007 is designed to excel as a monotherapy. For WVE-006, he agreed with the KOLs, stating that RNA editing is designed to preserve the body's natural ability to mount an acute phase response, a key differentiator from protein replacement therapy. He noted this was a core part of the original thesis for using RNA editing in AATD.