Ayala Reported FY2021 Within Expectations Ayala Reported FY2021 loss of $40.3 million or $(2.80) per share. This compares with our estimate of a loss of $40.9 million or $(3.00) per share, as both R&D and General Expenses were slightly below our estimates. Cash balance on December 31 was $37.3 million.One New Study Testing AL101 Is Underway, Another To Begin In 2H22. The “Window of Opportunity” study testing AL101 in ACC (adenoid cystic carcinoma) has begun treating patients prior to surgery and radiation therapy. This is intended to reduce recurrence rates and improve long-term survival, as well as to define the mechanism and effects of AL101 on cancer. Separately, the Phase 2 trial in T-ALL (T-cell acute lymphoblastic leukemia) is planned for 2H22.One AL101 Phase 2 Trial Is Expected To Report Data In 2H22, Another Was Discontinued. The AL101 ACCURACY Phase 2 in ACC treats patients that have progressive disease (recurrence or metastatic disease) following standard treatment (surgery and radiation). This is an open label trial with one cohort receiving 4 mg and a second cohort receiving 6 mg. Additional data from both cohorts is expected in 2H22. The AL101 TENACITY Phase 2 trial in triple negative breast cancer (TNBC) has been discontinued.RINGSIDE Trial Part A Continues. The RINGSIDE Phase 2/3 study in desmoid tumors has reached target enrollment for its Part A. In this first group, 36 patients are being treated at three dose levels to evaluate safety, tolerability, and tumor volume by MRI at 16 weeks. Interim data from the patients is expected in mid-2022. This Part A data will be used to determine the dose for Part B, the double-blind placebo-controlled treatment phase, expected to follow soon afterward.Conclusion: The financial results for FY2021 were close to expectations, and we expect the stock to be driven by the clinical trial milestones and data presentations beginning in mid-2022. We are reiterating our Outperform rating and price target of $12 per share. Read More >>