On May 23, 2023 Ayala Pharmaceuticals, Inc. (OTCQX: ADXS), a clinical-stage oncology company, reported first-quarter 2023 financial results and provided a corporate update (Press release, Ayala Pharmaceuticals, MAY 23, 2023, View Source [SID1234631952]).
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"Our immediate priority is to complete enrollment in our ongoing Phase 3 registration-enabling RINGSIDE study in which we are currently evaluating AL102 in desmoid tumors," said Ken Berlin, President and Chief Executive Officer of the Company. "We also look forward to providing a detailed update from the patients who were enrolled in Phase 2 (Part A) of RINGSIDE at the forthcoming ASCO (Free ASCO Whitepaper) annual meeting. For AL101, we expect to gain clarity this year on the development path in recurrent/metastatic adenoid cystic carcinoma (R/M ACC)."
First Quarter 2023 and Recent Business Highlights
Completed merger between Ayala Pharmaceuticals Inc. and Advaxis, Inc. The merger closed on January 19, 2023.
Continued progress in Phase 3 RINGSIDE trial: Enrollment continues in Phase 3 of the RINGSIDE trial, a double-blind placebo-controlled study enrolling up to 156 patients globally with progressive desmoid disease, randomized to either AL102 or placebo. The primary endpoint is progression free survival with secondary endpoints including objective response rates, duration of response, and patient-reported quality of life measures.
Upcoming Milestones
ASCO poster presentation on RINGSIDE: A poster featuring updated results from the Phase 2 portion of RINGSIDE, evaluating AL102 in desmoid tumors, will be presented at the 2023 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting on Saturday, June 3.
Data from Phase 1 trial of ADXS-504: ADXS-504 is being evaluated in a Phase 1 investigator-sponsored study at Columbia University in patients with biochemically recurrent (early) prostate cancer. Readout of initial clinical and PSA data are expected in 2023.
Gain clarity on path for future development plan for AL101 in recurrent/metastatic adenoid cystic carcinoma (R/M ACC), expected in 2023.
Consolidated Financial Results for the Quarter Ended March 31, 2023
Cash position On March 31, 2023, the consolidated cash and cash equivalents position was $16.8 million.
Revenue Collaboration revenue was $4 thousand in the three months ended March 31, 2023, compared with $0.5 million in the comparable period of 2022, mainly as a result of the Novartis Agreement.
R&D Expenses Research and development expenses were $7.3 million for the three months ended March 31, 2023 compared to $7.5 million for the three months ended March 31, 2022, a decrease of $0.2 million.
G&A Expenses General and administrative expenses were $4.6 million for the three months ended March 31, 2023 compared to $2.4 million for the three months ended March 31, 2022, an increase of $2.2 million.
Net Loss The net loss for the three months ended March 31, 2023 was approximately $7.4 million or ($1.67) per share based on approximately 4.4 million weighted average shares outstanding. This compares with a net loss for the three months ended March 31, 2022 of approximately $10.0 million or ($3.47) per share based on approximately 2.9 million weighted average shares outstanding.
For further details on the Company’s financial results, refer to our quarterly report on Form 10-Q for the three months ended March 31, 2023, filed with the Securities and Exchange Commission.