Ayala Pharmaceuticals, Biosight enter definitive merger agreement

Ayala Pharmaceuticals and Biosight announced they have entered into a definitive merger agreement pursuant to which Ayala will combine with Biosight in an all-stock transaction. Upon completion of the 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. Certain of the current Biosight shareholders have agreed to support the proposed transaction. The combined company will work to advance a portfolio of oncology assets, with a primary focus on Ayala’s AL102, a once-daily, potent, selective, oral gamma-secretase inhibitor and Biosight’s Aspacytarabine. AL102 is currently being evaluated in the registrational RINGSIDE study in desmoid tumors. There are currently no FDA-approved therapies for the treatment of unresectable, recurrent or progressive desmoid tumors. Data from the Phase 2 portion of RINGSIDE were presented at the recent American Society of Clinical Oncology Annual Meeting demonstrating AL102’s activity against progressing desmoid tumors. These data showed 50% partial response and 100% disease control rates in evaluable desmoid tumor patients treated with AL102 in the 1.2 mg once daily arm, the dosing regimen being tested in the ongoing Phase 3 study. The majority of the patients from Phase 2 have continued on study and are now in the open label extension of the Phase 3 portion of RINGSIDE. Ayala expects to present updated data on these patients at a medical conference later this year. Under the terms of the merger agreement, upon completion of the merger, ownership of the combined company will be split, with 55% ownership going to Biosight stockholders and 45% going to Ayala stockholders. The merger agreement has been unanimously approved by the Board of Directors of each company, by all directors entitled to vote. The transaction is expected to close prior to the end of the third quarter of 2023, subject to regulatory and other conditions including approval of Biosight stockholders. Effective as of the closing of the merger, the combined company will be led by Ayala’s existing senior management team, with Ken Berlin serving as President and CEO. Additionally, the Board of Directors is expected to consist of nine members, including four designated by Ayala and four designated by Biosight, as well as Mr. Berlin.