Tuesday, September 20, 2022
Ayala Pharmaceuticals, Inc. is a 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. Ayala’s approach is focused on predicating, identifying and addressing tumorigenic drivers of cancer through a combination of its bioinformatics platform and next-generation sequencing to deliver targeted therapies to underserved patient populations. The company has two product candidates under development, AL101 and AL102, targeting the aberrant activation of the Notch pathway with gamma secretase inhibitors to treat a variety of tumors including Adenoid Cystic Carcinoma, Triple Negative Breast Cancer (TNBC), T-cell Acute Lymphoblastic Leukemia (T-ALL), Desmoid Tumors and Multiple Myeloma (MM) (in collaboration with Novartis). AL101, has received Fast Track Designation and Orphan Drug Designation from the U.S. FDA and is currently in a Phase 2 clinical trial for patients with ACC (ACCURACY) bearing Notch activating mutations. AL102 is currently in a Pivotal Phase 2/3 clinical trials for patients with desmoid tumors (RINGSIDE) and is being evaluated in a Phase 1 clinical trial in combination with Novartis’ BMCA targeting agent, WVT078, in Patients with relapsed/refractory Multiple Myeloma. For more information, visit www.ayalapharma.com.
Robert LeBoyer, Vice President, Research Analyst, Life Sciences , Noble Capital Markets, Inc.
Refer to the full report for the price target, fundamental analysis, and rating.
Lowering AYLA To Market Perform. We are lowering our rating on Ayala Pharmaceuticals to Market Perform. Our Investment Thesis was based on successful development of AL101 and AL102 in several indications. However, the clinical trials have not advanced as we had anticipated while the risk to the stock has increased.
Clinical Trials. AL101 and AL102 were designed to block activation of the NOTCH pathway and its effects on cancer growth. We viewed the Phase 2 for AL101 in Adenoid Cystic Carcinoma (ACC) and the Phase 2/3 for AL102 in desmoid tumors as both Orphan indications as well as proof-of-concept that could lead to combination regimens in cancers with NOTCH mutations that are aggressive and difficult to treat. The Phase 2 TENACITY trial testing AL101 in triple-negative breast cancer (TNBC) was the first indication that could open large patient populations for AL101/AL102. However, this indication, as well as the collaboration with Novartis for multiple myeloma, has been discontinued.
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*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.