First Stage of Phase 2/3 RINGSIDE Trial Completed Enrollment. Ayala has announced that enrollment is complete for Part A of the Phase 2/3 RINGSIDE trial. This trial is testing the oral gamma-secretase inhibitor, AL102, in desmoid tumors. The data from this portion of the trial is expected to be announced in mid-2022, consistent with prior guidance.Part A Is Designed To Determine Safety, Efficacy, and Dosing For Part B. The first part of the RINGSIDE trial enrolled 36 patients to evaluate safety, tolerability, and changes in tumor volume by MRI scans. These data will be used to select the dose for Part B. A previous sub-study tested pharmacokinetics and found no food restrictions were needed.Part B Is Placebo-Controlled To Determine Efficacy. Upon completion of Part A, the Part B placebo-controlled portion will begin. Part B has a target enrollment of about 156 patients, with endpoints including progression-free-survival, objective response rate (ORR), duration of response (DOR), and quality of life measures. As a Phase 2/3 trial in a rare indication, we believe strong results could support an application for FDA approval.We View RINGSIDE As An Orphan Indication And Proof Of Concept. Desmoid tumors are a rare connective tissue tumor with no effective treatments. It was selected for trials after AL102 showed efficacy through gamma secretase inhibition. This is an activation step in the Notch pathway, a signaling pathway that is mutated or overactive in several cancers with an aggressive course of disease and poor prognosis. If successful, we believe additional trials in combination with other chemotherapy drugs could follow.Conclusion. We see the completion of Part A enrollment and confirmation of the data timelines as positive developments. The small capitalization biotechnology stocks have been in a prolonged decline, and AYLA has declined with the group. In view of the fundamental progress and advancing clinical trials, we continue to rate AYLA Outperform with a price target of $20 per share. Read More >>