Tuesday, May 17, 2022
Ayala Pharmaceuticals (AYLA)
Data Milestones Reiterated With 1Q22 Financial Report
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.
1Q22 Reported With Clinical Updates. Ayala Pharmaceuticals reported a 1Q22 loss of $10.0 million or $(0.66) per share. Interim results from the Phase 2/3 RINGSIDE trial testing AL102 in desmoid tumors are expected to be announced in mid-2022, unchanged from previous guidance. The company also expected to provide updates from the Phase 2 ACCURACY trial testing AL102 in adenoid cystic carcinoma (ACC), and plans to begin a trial in acute lymphoblastic leukemia (ALL) later in 2022. The company ended the quarter with $27.4 million in cash.
Looking Forward To Phase 2/3 Ringside Data. The RINGSIDE trial is testing AL102 for treatment of desmoid tumors, a rare tumor of the connective tissue. In February, Ayala announced that Part A of the trial had completed enrollment of 42 patients to evaluate the safety and tolerability, as well as tumor shrinkage at 16 weeks. Upon completion of Part A, the double-blind placebo-controlled Part B will begin testing efficacy with a target enrollment of 156 patients….
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.
