Thursday, October 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.
Merger Combines Cash And Phase 2/3 Product. Ayala has agreed to merge with Advaxis, Inc. (ADXS, $2.37, Not Rated), with Ayala shareholders owning 62.5% and Advaxis shareholders owning 37.5% of the newly combined company. Importantly, Advaxis had $28.2 million on July 31, 2022, which we believe will allow continuation of the RINGSIDE Phase 2/3 trial in desmoid tumors.
Combined Company Will Have A Late Stage Product and An Immunotherapy Technology. The new company will have funding to move AL102 forward and to continue development of Advaxis’ proprietary Lm platform for antigen delivery. This platform is based on its proprietary technology using a modified bacteria, Listeria monocytogenes, for delivering antigens to stimulate the immune system against tumors. Advaxis ADXS-504 is in a dose-finding Phase 1 study for prostate cancer.
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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.