On August 10, 2023 Ayala Pharmaceuticals, Inc. (OTCQX: ADXS), a clinical-stage oncology company, reported second-quarter 2023 financial results and provided a corporate update (Press release, Ayala Pharmaceuticals, AUG 10, 2023, View Source [SID1234634181]).
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"We continue to make progress advancing our lead candidate AL102, which is being evaluated in the ongoing Phase 3 registration-enabling RINGSIDE for the treatment of desmoid tumors. We recently concluded an instructive and successful End-of-Phase-2 (EOP2) meeting with the U.S. Food and Drug Administration (FDA) and have confirmed that we are agreement with the FDA on key elements of the randomized Phase 3 segment of RINGSIDE," said Ken Berlin, President and Chief Executive Officer of the Company. "The most recent data from Phase 2 of RINGSIDE presented at ASCO (Free ASCO Whitepaper) were encouraging and we look forward to presenting a further update at the ESMO (Free ESMO Whitepaper) congress in October this year. We are excited, also, to expand our clinical pipeline through the recently announced proposed merger with Biosight. The addition of Biosight’s lead asset aspacytarabine (BST-236) fits with our strategic vision and core competencies. Along with the merger, we have plans to strengthen our balance sheet and execute our clinical plans, with the goal of creating sustainable value for patients and shareholders."
Second Quarter 2023 and Recent Business Highlights
End-of-Phase 2 meeting with FDA regarding AL102 for desmoid tumors: Ayala confirmed that it is in agreement with the FDA on key elements of the randomized Phase 3 segment of RINGSIDE, evaluating AL102 in desmoid tumors. The FDA accepted the selection of the 1.2 mg once daily dose for Phase 3 and the completed and proposed clinical pharmacology plan. Enrollment in Phase 3 commenced in November 2022, and is continuing globally as planned, with target enrollment of 156 patients. The primary endpoint is progression free survival with secondary endpoints including objective response rates, duration of response, and patient-reported quality of life measures.
Updated results from Phase 2 of RINGSIDE study presented at 2023 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting: ASCO (Free ASCO Whitepaper) poster highlighted 50% partial response and 100% disease control rates in evaluable desmoid tumor patients treated with AL102 1.2 mg once daily (the selected Phase 3 dose) at a cut off date of January 3, 2023. Tumor responses, volume and T2 signal reduction were observed earlier in the 1.2 mg once daily group, with deeper and sustained treatment responses. AL102 continues to be generally well tolerated and has a manageable safety profile.
Definitive merger agreement with Biosight: Ayala entered into a definitive agreement with Biosight Ltd., pursuant to which, Ayala will combine with Biosight in an all-stock transaction. Upon completion of the proposed merger, the combined company will operate under the name Ayala Pharmaceuticals, Inc., and will continue to trade on the OTCQX under Ayala’s current ticker symbol ("ADXS"). The combined company will work to advance a portfolio of oncology assets, with a primary focus on Ayala’s AL102, and Biosight’s aspacytarabine (BST-236). The transaction is expected to close near the end of the third quarter of 2023, subject to regulatory and other conditions including approval of Biosight stockholders.
Upcoming Milestones
ESMO poster presentations on AL102 and AL101: Updated results from Phase 2 of RINGSIDE evaluating AL102 in desmoid tumors and final results from the ACCURACY trial evaluating AL101 in patients with recurrent/metastatic (R/M) adenoid cystic carcinoma (ACC) have been selected for presentation at the European Society for Molecular Oncology (ESMO) (Free ESMO Whitepaper) Congress 2023, to be held in Madrid, Spain 20-24 October 2023.
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 Second Quarter Ended June 30, 2023
Cash position On June 30, 2023, the Company’s consolidated cash and cash equivalents position was $7.1 million.
Revenue Collaboration revenue was $9 thousand in the three months ended June 30, 2023, compared with $38 thousand in the comparable period of 2022.
R&D Expenses Research and development expenses were $5.7 million for the three months ended June 30, 2023 compared to $5.6 million for the three months ended June 30, 2023.
G&A Expenses General and administrative expenses were $2.7 million for the three months ended June 30, 2023 compared to $2.3 million for the three months ended June 30, 2023.
Net Loss The net loss for the three months ended June 30, 2023 was approximately $8.7 million or ($1.82) per share based on approximately 4.8 million weighted average shares outstanding. This compares with a net loss for the three months ended June 30, 2022 of approximately $8.1 million or ($2.83) per share based on approximately 2.9 million weighted average shares outstanding.
For further details on the Company’s financial results, including results for the six-month period ended June 30, 2023, refer to our quarterly report on Form 10-Q for the quarter ended June 30,2023, filed with the Securities and Exchange Commission.