Boris Tolkachev

Boris Tolkachev of Freedom Broker asked about the Kordstrom BLA submission, specifically whether the ongoing statistical analysis would provide new insights and for details on the planned post-BLA open-label trial.

Answer

Chief Scientific Officer Mark Lowdell explained that the new statistical analysis plan is a significant improvement and is likely to identify stronger data to support the MAA and BLA submissions. He clarified that the open-label trial is planned to begin after the BLA submissions, likely in early 2027, and its data would not be part of the initial package, as they believe the data from the current crossover trial is adequate for filing.

Boris Tolkachev of Freedom asked about expectations for updates on the future clinical development roadmap and whether any interim results from the ORCA-OL trial would be shared ahead of a full publication.

Answer

President & CMO Dr. Cindy Jacobs stated that the full ORCA-OL study database is expected to be locked by the end of the year, with plans to present the complete data at conferences in 2026 rather than releasing interim results. CEO Rick Stewart emphasized the value of the one-year exposure data, noting the tolerability profile appears consistent with Phase 3 trials and that the company is eager to see the long-term efficacy results.

Boris Tolkachev asked about the company's expectations for the effect size in the upcoming Phase III vaping study (ORCA-V2), given the relatively high placebo effect observed in the Phase II ORCA-V1 trial, and whether the FDA had raised questions about this.

Answer

Chief Medical Officer Dr. Cindy Jacobs explained that the ORCA-V1 results were instrumental in designing the Phase III trial. The ORCA-V2 study is powered at over 90% with approximately 800 subjects to accommodate the potential for a higher placebo rate, ensuring the trial is not underpowered. She noted that higher placebo rates were also seen in smoking cessation trials two decades ago, so this was anticipated.

Boris Tolkachev of Freedom Broker asked for clarification on why ORCA-OL enrollment was completed with fewer than the initially planned 650 patients and inquired about the risk of patient discontinuation and the strategies to maintain engagement.

Answer

Dr. Cindy Jacobs, President and Chief Medical Officer, clarified that 650 was a maximum target and enrollment was capped below 500 because the early discontinuation rate was very low, providing confidence in meeting data requirements. She added that retention programs are in place across all trial sites and are proving effective, with the discontinuation rate remaining very low.