Study Objectives Primary Sample Clauses

Study Objectives Primary. ● To assess efficacy as measured by objective response rate (O▇▇) by Blinded† Independent Central Review (BICR) based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 of intratumoral tavo-EP in combination with pembrolizumab (collectively ‘the combined treatment’) in subjects with inoperable locally advanced or metastatic TNBC Secondary: ● To assess safety and tolerability of the combined treatment in subjects with inoperable locally advanced or metastatic TNBC ● To assess duration of response (DOR), O▇▇ (investigator-assessed), immune O▇▇ (iORR), progression-free survival (PFS), immune PFS (iPFS), and overall survival (OS) of combined treatment ● * *Confidential material redacted and filed separately with the Commission. † Reviewer will be blinded to treated and untreated lesion

Study Objectives Primary. ● To assess and quantify patient journey (e.g., time to diagnosis, time to initiate therapy, patient satisfaction) for users of the VSA program Secondary: ● To assess patient journey completion rates for users of the VSA program ● To assess and quantify PAP compliance in users of the VSA program Study Endpoints Primary ● Time (number of days) from when participant is told they may have OSA to OSA diagnosis ○ Time (number of days) from when participant is told they may have OSA to when they receive HST prescription ○ Time (number of days) from when participant receives HST prescription to when they receive their diagnosis ● Time (number of days) from OSA diagnosis to PAP therapy initiation ● Time (number of days) from therapy initiation to when 90-day compliance threshold is achieved Secondary ● Completion rates ○ Among individuals who had an HST ordered, % of individuals who completed the HST ○ Among individuals prescribed a PAP device, % of individuals who filled the order (PAP device delivered to them) ○ Among individuals prescribed a PAP device, % of individuals who used the PAP device at least once during the 90 days ● Compliance Metrics ○ Percent of participants who meet 90 day compliance success criteria, as defined by: ■ ≥ 4 hours per night on 70% of nights during a consecutive 30 day period anytime during the first 90 days This is a single group, unblinded, prospective clinical study Non-significant risk (NSR)