Edward Nash

Edward Nash with Canaccord asked about Veru's rationale for selecting injectable semaglutide over oral semaglutide for the Phase 2b PLATEAU study, and inquired whether the FDA specifically discussed and accepted the stair climb test and patient-reported outcomes as sufficient functional endpoints for a potential approval pathway.

Answer

Dr. Mitchell Steiner, Chairman, CEO, and President of Veru, explained that using injectable semaglutide minimizes variability from the Phase 2b QUALITY study, ensuring consistency, and that while oral semaglutide is slightly less potent, the active ingredient is the same, allowing for safety bridging in Phase III. He confirmed specific FDA discussions regarding the stair climb test, including requirements for duplicate loaded and unloaded runs to normalize weight and challenge muscles, and noted that patient-reported outcomes in the Phase 2b study will help define clinical meaningfulness.

Edward Nash (Canaccord Genuity Group Inc.) inquired about Veru's decision to use injectable semaglutide in the Phase II-B PLATEAU study instead of the oral form, and whether specific functional endpoints like the stair climb test and patient questionnaires were discussed with the FDA for potential approval pathways.

Answer

Dr. Mitchell Steiner (Chairman, CEO, and President, Veru) explained that using injectable semaglutide minimizes differences from the previous QUALITY study, and while injectable is slightly more effective, the active ingredient allows for safety bridging to future oral formulations. He confirmed detailed discussions with the FDA regarding the stair climb test, including requirements for duplicate runs and both loaded/unloaded tests, drawing on 20 years of company experience. Dr. Steiner also noted the importance of patient-reported outcomes in the PLATEAU study to establish clinical meaningfulness.

Speaking for Edward Nash of Canaccord Genuity, Xinwei asked about relacorilant's positioning in ovarian cancer, physician sentiment on its use in early vs. late-stage disease, and potential overlapping toxicities in future combination therapies.

Answer

Roberto Vieira, President of Oncology, outlined a path to market leadership in platinum-resistant ovarian cancer, projecting over $1 billion in long-term revenue, supported by flexible use across therapy lines. He and CEO Joseph Belanoff noted strong physician interest for use in earlier lines due to the drug's efficacy and safety. Chief Development Officer William Guyer stated there are no concerns about overlapping toxicities with other agents.

Edward Nash asked about the oncology program, specifically the treatment paradigm for relacorilant versus competitors like Elahere and any feedback from oncologists on the ROSELLA data. He also inquired about the revenue cadence for the remainder of the year, questioning if a large bolus should be expected in Q2 following the resolution of pharmacy issues.

Answer

Roberto Vieira, President of the Oncology division, explained that relacorilant plus nab-paclitaxel is positioned to become a new standard of care in platinum-resistant ovarian cancer and can be used before or after biomarker-driven agents. Sean Maduck, President of the Endocrinology division, and CEO Joseph K. Belanoff clarified that they do not expect a single revenue bolus in Q2, but rather accelerating growth throughout the rest of the year.

Edward Nash from Canaccord Genuity inquired about the patient composition of the initial 50-subject open-label ARMOR study data expected in Q4 2021 and sought confirmation that the registrational part of the trial would be powered based on the blinded study using only Aramchol meglumine.

Answer

President and CEO Allen Baharaff clarified that the initial 50-patient cohort is a randomized mix of subjects from the 24, 48, and 72-week biopsy groups, not just the 24-week group. He confirmed that while open-label safety data supports the NDA, the study's powering and efficacy analysis for a potential accelerated approval submission will be based on the blinded portion of the trial using the higher-exposure Aramchol meglumine.

Edward Nash of Canaccord Genuity asked for clarification on the patient cohort structure for the open-label ARMOR Phase III study and confirmed that the pivotal, blinded portion of the trial would exclusively use the new Aramchol meglumine formulation for its accelerated approval submission.

Answer

Executive Allen Baharaff clarified that the initial 50 patients are a randomized mix of the 24, 48, and 72-week biopsy groups, not sequential cohorts. He confirmed the blinded part of the study will use Aramchol meglumine for the NDA submission and that the open-label data is crucial for determining safety, optimal treatment duration, and the final powering of the study, given the higher drug exposure.