Ayala Pharmaceuticals Inc (ADXS)

[cdiddy01]

Hi Hov,

Couple quick questions if you have a chance:

1.Why are there so few patients in the P1 NEO trial? Was this to be expected?

2. Any thoughts on the updated (post AACR) NEO bullet points from the recent press release? Info below:

- Data from the two MSS colorectal cancer patients dosed with ADXS-NEO at 1x108 CFU demonstrated increased CD8+ T cell infiltration in the tumor microenvironment after three doses of ADXS-NEO. Both patients had metastatic colorectal cancer, which is considered to be a “cold” tumor and typically exhibits little CD8+ T cell infiltration and resistance to immunotherapy, yet both successfully transitioned from “cold” tumors into “hot” tumors with ADXS-NEO therapy. An estimated 80-85% of colorectal cancer patients are MSS.
- Two patients (one treated at 1x109 and one at 1x108 CFU) achieved stable disease per RECIST 1.1 criteria. Another patient has yet to be evaluated but has experienced normal performance status and an active lifestyle over the three months of therapy with ADXS-NEO at 1x108 CFU.