Thomas...

Thomas asked what specific data or outcomes would be needed from the fourth cohort of UX701 in Wilson disease to confidently advance the 4 x 10^13 vg/kg dose into future studies.

Answer

Emil Kakkis, CEO and President, stated the goal is to see a substantial and compelling effect in the majority of patients, aiming to enhance this fraction by increasing the dose. Eric Crombez, Chief Medical Officer, emphasized the need for the majority of patients to come off standard of care (chelators and zinc). He noted that changes in the immunomodulation program are expected to be additive or synergistic with the increased dose, and multiple copper measurements will aid in decision-making.

Thomas inquired about the expected stronger performance in NeoGenomics' non-clinical data business in Q4, including the underlying reasons and funnel visibility, and the reception and "chatter" surrounding the RaDaR ST MRD assay among community clinicians following the favorable summary judgment.

Answer

CFO Jeff Sherman confirmed Q4 is historically the strongest for the data business, which saw double-digit growth in Q3 and is expected to show sequential growth. COO Warren Stone stated that while RaDaR ST hasn't clinically launched, the favorable summary judgment has created a positive "vibe" in community oncology due to the assay's sensitivity and NeoGenomics' portfolio effect for single-vendor consolidation. CEO Tony Zook reinforced the "preferred partner of choice" strategy, emphasizing the breadth of their MRD portfolio, including flow MRD, Adaptive partnership, RaDaR ST, and future next-gen MRD.

Thomas asked if NeoGenomics still expects stronger performance in the data business on the non-clinical side in Q4, seeking color on the reasons for this anticipated strength. He also inquired about the reception of the Radar ST MRD assay among clinicians in the community setting following the favorable summary judgment.

Answer

CFO Jeff Sherman confirmed that Q4 is historically the strongest quarter for the data business, which saw double-digit growth in Q3, and sequential growth over Q3 is expected in Q4. COO Warren Stone stated that while Radar ST MRD assay has not yet clinically launched, the news of the summary judgment has circulated positively within the community oncology setting. He highlighted the assay's sensitivity and the portfolio effect of consolidating testing needs with a single vendor as key factors in the positive reception. CEO Tony Zook reinforced the strategy of offering a comprehensive suite of MRD products.

Thomas..., on behalf of Subbu Nambi, asked about the company's focus for Prolaris amid NCCN guideline confusion and the strategy for GeneSight following recent payer decisions, specifically regarding where management is focusing its efforts.

Answer

Chief Commercial Officer Mark Verratti explained that for Prolaris, the focus is on KOL engagement to clear up guideline confusion and increased investment, bolstered by the new PATHOMIQ AI partnership. For GeneSight, he clarified that the sales force remains focused on providers, while the executive team separately handles payer engagement, evidence generation, and advocacy. CEO Paul Diaz added that state biomarker legislation is a key initiative to mitigate the UnitedHealthcare policy change.