Ayala Pharmaceuticals (AYLA)
RINGSIDE Data Presentation Announced With 2Q Results
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.
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Financial Loss Was Less Than Expected. Ayala reported 2Q22 loss of $ 8.2 million or $(0.54) per share, compared with our estimated loss of $10.9 million or $(0.71) per share. The difference was largely due research and development spending of $5.6 million coming in lower than our estimate of $8.2 million. Cash on hand at the end of the quarter was $20.1 million.
Phase 2/3 RINGSIDE Trial Data Presentation Planned At ESMO. In July, Ayala announced preliminary findings from the Phase 2/3 RINGSIDE trial testing AL102 in desmoid tumors. As discussed in our note from July 6, the company reported encouraging results although no data was released. It stated that the trial had shown sufficient tumor activity, safety, and reiterated plans to initiate Phase B later in the year. The data presentation is now planned for the meeting of the European Society for Medical Oncology (ESMO) to be held September 9-13 in Paris, France. …
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