Matthew Cross

Question 1

Matthew Cross's questions to Aldeyra Therapeutics (ALDX) leadership • Q1 2022

May 5, 2022

Question

Matthew Cross of Alliance Global Partners requested details on the statistical handling of the two primary endpoints in TRANQUILITY-2, including the rationale for the Schirmer's test analysis and the methodology for the ocular redness assessment, and asked if this approach would be mirrored in the backup studies.

Answer

CEO Dr. Todd Brady clarified that using multiple time points for both endpoints is statistically more powerful and clinically more relevant. For the Schirmer test, assessing before and after the fourth dose captures both cumulative and acute drug activity. For redness, all ten time points in the chamber are included in the model to assess the slope of improvement. Dr. Brady confirmed this exact statistical plan will be mirrored in the backup studies to ensure consistency.

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Question 2

Matthew Cross's questions to MEI Pharma (MEIP) leadership • Q4 2021

Sep 3, 2021

Question

Matthew Cross of Alliance Global Partners inquired about the filing strategy for the marginal zone lymphoma (MZL) cohort of the TIDAL study and the rationale for including venetoclax in the CLL combination trial, given the high response rates previously seen with zandelisib plus rituximab alone.

Answer

Dan Gold, President and CEO, confirmed a staggered filing approach, with the follicular lymphoma data submitted first, followed by the MZL data once that arm is fully enrolled. He explained that adding venetoclax in the CLL trial is driven by the strategic goal of achieving deep, durable remissions and MRD negativity, which enables a time-limited therapy—a key objective for physicians and patients that is not typically achieved with B-cell receptor agents alone.