Wednesday, December 02, 2020

Ayala Pharmaceuticals (AYLA)
Top NOTCH Targeting for Broad Oncology Indications, Initiating Coverage at Outperform

Ayala Pharmaceuticals Inc clinical-stage oncology company focused on developing and commercializing small molecule therapeutics for patients suffering from rare and aggressive cancers, primarily in genetically defined patient populations. The company's current portfolio of product candidates, AL101 and AL102, targets the aberrant activation of the Notch pathway with gamma secretase inhibitors. Its product candidate, AL101, is being developed as a potent, selective, injectable small molecule gamma secretase inhibitor, or GSI. It is also developing AL101 for the treatment of T-ALL, an aggressive, rare form of T-cell specific leukemia.

Ahu Demir, Ph. D., Biotechnology Research Analyst, Noble Capital Markets, Inc.

Refer to the full report for the price target, fundamental analysis, and rating.

Clinical benefit in ACC patients. We initiate coverage on Ayala Pharmaceuticals (AYLA). Ayala’s assets, AL101 and AL102, are gamma-secretase inhibitors that hold promising potential in multiple oncology indications. Interim results from the ongoing Phase 2 clinical study (ACCURACY) of AL101 showed encouraging clinical activity (68% disease control rate) in patients with adenoid cystic carcinoma (ACC, rare cancer that predominantly arises within salivary glands). In our view, Ayala is the most advanced in the clinical for the treatment of ACC patients harboring NOTCH-activating mutations and holds Fast Track and Accelerated Approval Designations. We assume a straightforward regulatory process attributed to high unmet needs with limited current treatment options in this untapped market.

Pipeline expansion offers substantial upside.  We believe further value to crack through the defenses of other oncology indications beyond ACC upon meaningful data. Plenty of value-unlocking catalysts should support the stock near-medium term including the commencement of three Phase 2 clinical studies in triple-negative breast cancer (TNBC, in Q4 2020), in desmoid tumors (in H1 2021), and in acute ...

This Company Sponsored Research is provided by Noble Capital Markets, Inc., a FINRA and S.E.C. registered broker-dealer (B/D).

*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary.  Proper due diligence is required before making any investment decision.