On February 10, 2023 Ayala Pharmaceuticals, Inc. (f/k/a Advaxis Inc.) (the "Company," "New Ayala," "we," "us" or "our") (OTCQX: ADXS), a clinical-stage oncology company, reported financial results for the fiscal year ended October 31, 2022 (Press release, Ayala Pharmaceuticals, FEB 10, 2023, View Source [SID1234627053]).
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Management Commentary
"We were pleased to close our previously announced merger in January 2023," said Kenneth A. Berlin, President and Chief Executive Officer of the Company. "Our immediate priorities include executing on Part B of the ongoing registration-enabling RINGSIDE study evaluating AL102 in desmoid tumors. We believe that AL102 has best in class potential and, if approved, may have important clinical advantages including safety, convenient once daily dosing and lower pill burden. For AL101, we expect to gain clarity this year on the development path in recurrent/metastatic adenoid cystic carcinoma (R/M ACC). We also continue to make progress on the development of ADXS-504 for the treatment of early prostate cancer. The dose escalation part of the investigator-sponsored trial at Columbia University has been completed and we are now enrolling patients in an expansion cohort."
Fiscal Year 2022 and Recent Business Highlights:
In October 2022, the Company, which was then known as Advaxis, Inc., entered into a definitive agreement to merge with the entity now known as Old Ayala, Inc. (which prior to the merger was named Ayala Pharmaceuticals, Inc.) The merged company is focused primarily on the development and commercialization AL102 for the treatment of desmoid tumors. The merger closed on January 19, 2023, at which time the Company changed its name to Ayala Pharmaceuticals, Inc.
Announced positive interim data from Part A of the Phase 2/3 RINGSIDE study of AL102 in desmoid tumors: Data showed that AL102 had efficacy across all cohorts, with early responses that deepened over time. AL102 was well tolerated at all three dosing regimens with no dose-limiting toxicities and no Grade 4/5 adverse events. The data were featured in an oral presentation at ESMO (Free ESMO Whitepaper) 2022 and in a poster at the CTOS 2022 annual meeting.
Initiated Part B (Phase 3 segment) of the RINGSIDE study in desmoid tumors: Part B of RINGSIDE is a double-blind placebo-controlled study enrolling up to 156 patients with progressive desmoid disease, randomized between 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.
Fast Track designation granted for AL102: The U.S. FDA granted Fast Track designation for AL102 for the treatment of progressing desmoid tumors. The designation holds important advantages that may expedite the development and regulatory review of AL102.
Presented data on AL101 in adenoid cystic carcinoma (ACC) at 2022 ASCO (Free ASCO Whitepaper) annual meeting: In a poster at ASCO (Free ASCO Whitepaper), an update was provided on the ACCURACY study, the only prospective study conducted to date in ACC patients carrying Notch-activating mutations. An overall disease control rate of 66.7% was observed. The median PFS in each of the 4mg and 6mg dose AL101 cohorts was 3.7 months and 6.7 months, respectively, among the patients who had a partial response.
Continued progress with Phase 1 clinical trial of ADXS-504 for early prostate cancer: Dose escalation has been completed and enrollment at second dose level is being expanded at Columbia University. Four out of six patients treated are still on study and PSA values are being followed up. ADXS-504 has been well tolerated with no serious adverse events reported.
New Ayala’s Consolidated Financial Results for the Fiscal Year Ended October 31, 2022
Cash position On October 31, 2022, the consolidated cash and cash equivalents position was $25.2 million.
Revenues: Revenues for the fiscal year 2022 were $250,000, compared with $3.2 million for the fiscal year 2021.
R&D expenses: Research and development expenses for fiscal year 2022 were $7.6 million, compared with $10.6 million for fiscal year 2021.
G&A expenses: General and administrative expenses for fiscal year 2021 were $8.9 million, compared to $11.5 million for fiscal year 2021.
Net loss: The net loss for the fiscal year ended October 31, 2022 was approximately $14.4 million or ($8.46) per share based on approximately 1.8 million weighted average shares outstanding. This compares with a net loss for fiscal year 2021 of approximately $17.9 million or ($11.07) per share based on approximately 1.6 million weighted average shares outstanding.
The above financial results, as well as the financial tables included in this press release, reflect the financial performance of the Company, then known as Advaxis Inc., prior to completion of the merger and do not include any contribution from Old Ayala.
For further details on the Company’s financial results, refer to our Annual report on Form 10-K for the twelve months ended October 31, 2022, filed with the Securities and Exchange Commission. Old Ayala will report consolidated financial results for the full year ended December 31, 2022 (a period completed prior to the merger) on or about March 31, 2023.