On November 4, 2022 Ayala Pharmaceuticals, Inc. (Nasdaq: AYLA), a clinical-stage oncology company focused on developing and commercializing small molecule therapeutics for patients suffering from rare tumors and aggressive cancers, reported third-quarter 2022 financial results and provided a corporate update (Press release, Ayala Pharmaceuticals, NOV 4, 2022, View Source [SID1234623114]).
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"Our team looks forward to completing the recently announced merger with Advaxis which we believe will complement our pipeline. Importantly, we believe that the consummation of the merger will provide us with the financial resources to advance development of AL102 for desmoid tumors and enable an enhanced presence in the United States," said Roni Mamluk, Ph.D., Chief Executive Officer of Ayala. "We remain focused on the continued development of our candidates AL102 and AL101. We had an opportunity to share the very promising interim results from Part A of the ongoing RINGSIDE study of AL102 with the broader oncology community at ESMO (Free ESMO Whitepaper). We look forward to reporting longer-term data in 2023 and to executing on Part B, the randomized Phase 3 portion of RINGSIDE."
Third-quarter 2022 and Recent Business Highlights
In October, Ayala announced a definitive agreement to merge with Advaxis, Inc.: The merger would result in a combined company that will focus on the development and commercialization of Ayala’s lead program AL102 for the treatment of desmoid tumors. Ayala stockholders will own approximately 62.5% of the combined company’s outstanding common stock and Advaxis stockholders will own approximately 37.5%, subject to the terms of the merger agreement. At the closing of the merger, Ayala will be delisted from The Nasdaq Global Market, and the combined company’s common stock is expected to begin trading on the OTCQX, subject to Advaxis’s planned efforts to have the stock of the combined company listed on Nasdaq, as to which no assurances can be made. The merger is expected to close by the end of Q1 2023, subject to approval by Ayala’s shareholders and the satisfaction of customary closing conditions.
On October 6, the Company hosted a key opinion leader (KOL) webinar on the unmet medical needs and evolving treatment landscape of desmoid tumors: The webinar featured presentations by Professors Bernd Kasper, MD, Ph.D., from the Mannheim University Medical Center, and Robin Jones, MD, from The Royal Marsden Hospital and Institute of Cancer Research. A replay of the webinar, including slides, can be found here.
Positive interim data from Part A of the Phase 2/3 RINGSIDE study of AL102 in desmoid tumors presented at ESMO (Free ESMO Whitepaper): Data showed efficacy across all cohorts, with early responses that deepened over time. The first confirmed partial response (PR) was achieved at week 16 and 3 additional unconfirmed PRs over the follow-up period. AL102 was well tolerated at all three dosing regimens with no dose-limiting toxicities and no Grade 4/5 adverse events. Part B, the Phase 3 portion of RINGSIDE, is open for enrollment with a selected dose of 1.2mg once daily.
Fast Track designation granted for AL102: In September, 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.
Upcoming Milestones
Continue enrollment in Phase 3 of the RINGSIDE trial: Part B, the Phase 3 portion of the RINGSIDE trial, 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.
A poster featuring the interim data from Part A of RINGSIDE has been selected for presentation at the Connective Tissue Oncology Society (CTOS) 2022 Annual Meeting, taking place November 16-19 in Vancouver, Canada.
Gain clarity from U.S FDA on the registration path for AL101 in recurrent/metastatic adenoid cystic carcinoma (R/M ACC), expected in early 2023
Expected closing of merger with Advaxis, by the end of Q1 2023, subject to approval by Ayala’s shareholders and the satisfaction of customary closing conditions
Present longer-term data from Part A of RINGSIDE with AL102, expected in mid-2023
Third-Quarter 2022 Financial Results
Cash Position: Cash and cash equivalents were $11.2 million as of September 30, 2022.
Collaboration Revenue: Collaboration revenue was $91 thousand for the third quarter of 2022, as compared to $625 thousand for the corresponding quarter in 2021.
R&D Expenses: Research and development expenses were $7.2 million for the third quarter of 2022, compared to $7.4 million for the corresponding quarter in 2021.
G&A Expenses: General and administrative expenses were $2.9 million for the third quarter of 2022, compared to $2.2 million for the third quarter of 2021.
Net Loss: Net loss was $10.2 million for the third quarter of 2022, resulting in basic and diluted net loss per share of $0.66. This compares with a net loss of $9.8 million for the third quarter of 2021 or basic and diluted net loss per share of $0.68 for that quarter.
For further details on the company’s financial results, refer to our Quarterly Report on Form 10-Q for the three months ended September 30, 2022, filed with the Securities and Exchange Commission ("SEC") on November 3, 2022.