On May 16, 2022 Ayala Pharmaceuticals, Inc. (Nasdaq: AYLA), 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, reported first-quarter 2022 financial results and provided a corporate update (Press release, Ayala Pharmaceuticals, MAY 16, 2022, View Source [SID1234614637]).
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"We continued to execute on advancing our clinical programs during the first quarter of 2022," said Roni Mamluk, Ph.D., Chief Executive Officer of Ayala. "Our highest immediate priority is completing Part A of the RINGSIDE study evaluating AL102 in desmoid tumors and we are on target to announce initial interim data around mid-year. This will be followed by initiation of Part B, the randomized portion of the study, immediately thereafter. We are very encouraged by the positive feedback received from investigators in the study and by early signs of anti-tumor activity. Other important milestones expected this year include clinical updates from the ongoing ACCURACY trial of AL101 in adenoid cystic carcinoma and the planned initiation of a Phase 2 trial of AL102 in T-ALL."
First-quarter 2022 and Recent Business Highlights
Completed enrollment of Part A of the Phase 2/3 RINGSIDE study of AL102 in desmoid tumors: 42 patients have been enrolled in Part A of the RINGSIDE study, which is evaluating the safety and tolerability of AL102, as well as tumor volume by MRI at 16 weeks. Three dosing regimens of AL102 are being tested to determine the optimal dose regimen to advance forward.
Initiated "Window of Opportunity" study of AL101 in adenoid cystic carcinoma (ACC): The study, which is being conducted in collaboration with M.D. Anderson Cancer Center and the Adenoid Cystic Carcinoma (ACC) Research Foundation, is focused on determining the effects of AL101 for the treatment of ACC and other cancers. The goals of the study are to better understand the mechanism of AL101, determine the best treatment regimen and generate data for the future development strategy.
Upcoming Milestones
Initial interim data from pivotal Phase 2/3 RINGSIDE trial in desmoid tumors: Ayala expects to report an initial interim data read-out from Part A of Phase 2/3 RINGSIDE trial of AL102 in desmoid tumors around mid-2022. Part B of the study will be a double-blind placebo-controlled study enrolling up to 156 patients with progressive disease, randomized between AL102 or placebo. The study’s primary endpoint will be progression free survival with secondary endpoints including objective response rates, duration of response and patient reported quality of life measures.
Clinical data from Phase 2 ACCURACY trial of AL101 in ACC: The Phase 2 ACCURACY clinical trial is an open-label, single-arm, multi-center study to assess the clinical activity of AL101 using radiographic assessments of patients with R/M ACC demonstrating disease progression within 6 months prior to dosing. A poster at the 2022 ASCO (Free ASCO Whitepaper) Annual Meeting is expected to feature safety, efficacy, pharmacokinetics, and pharmacodynamics data from the 6mg AL101 cohort in the trial.
Initiate Phase 2 clinical trial evaluating AL102 in T-cell acute lymphoblastic leukemia (T-ALL): Ayala plans to begin a Phase 2 clinical trial evaluating AL101 in R/R T-ALL in the second half of 2022.
First-Quarter 2022 Financial Results
Cash Position: Cash and cash equivalents were $27.4 million as of March 31, 2021, as compared to $37.3 million at December 31, 2021.
Collaboration Revenue: Collaboration revenue was $0.4 million for the first quarter of 2022, as compared to $1.0 million for the corresponding quarter in 2021.
R&D Expenses: Research and development expenses were $7.5 million for the first quarter of 2022, compared to $6.9 million for the corresponding quarter in 2021.
G&A Expenses: General and administrative expenses were $2.4 million for the first quarter of 2022, compared to $2.3 million for the first quarter of 2021.
Net Loss: Net loss was $10.0 million for the first quarter ended March 31, 2022, resulting in basic and diluted net loss per share of $0.66. This compares with a net loss of $9.6 million for the first quarter ended March 31, 2021, or basic and diluted net loss per share of $0.74.
For further details on the company’s financial results, refer to form Quarterly Report on Form 10-Q for the three months ended March 31, 2022, filed with the SEC on May 16, 2022.