Friday, July 28, 2023
Ayala Pharmaceuticals, Inc. (OTCQX: ADXS), a publicly-traded clinical-stage oncology company, and Biosight Ltd., a privately-held pharmaceutical company developing innovative therapeutics for hematological malignancies and disorders, today 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 (“ADXS”). 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 (GSI) and Biosight’s Aspacytarabine (BST-236). 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.
“The addition of Biosight’s lead asset aspacytarabine (BST-236) fits with our strategic vision and core competencies and provides us with additional avenues towards key clinical catalysts,” said Ken Berlin, President and CEO of Ayala. “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.”
Pini Orbach, PhD, Chairman of Biosight, commented, “The Ayala team shares our commitment to bringing innovative treatments to cancer patients in need and we are excited to enter into this merger. Leveraging the combined capabilities and resources of both organizations will provide a truly unique opportunity to build a leading, publicly-traded oncology company with advanced and diverse clinical stage assets. I would like to express my deepest appreciation to the entire Biosight team, and I am proud of their excellent work and dedication in advancing aspacytarabine and our pipeline.”
About the Merger
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.
Management and Organization
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.
Advisors
Morgan, Lewis & Bockius LLP and Meitar are serving as legal counsel to Ayala. Goodwin Procter LLP and Horn & Co. Law Offices are serving as legal counsel to Biosight.
About Ayala Pharmaceuticals, Inc.
Ayala Pharmaceuticals, Inc. is a clinical-stage oncology company primarily focused on developing and commercializing small molecule therapeutics for people living with rare tumors and aggressive cancers and is also developing proprietary Lm-based antigen delivery products for patients suffering from more common cancers. The Company’s lead candidates under development are the oral gamma secretase inhibitor, AL102, for desmoid tumors; ADXS-504, a Lm-based therapy for early-stage prostate cancer; and the intravenous gamma secretase inhibitor, AL101, for adenoid cystic carcinoma. AL102 has received Fast Track Designation from the U.S. FDA and is currently in the Phase 3 segment of a pivotal study for patients with desmoid tumors (RINGSIDE). For more information, visit www.ayalapharma.com.
About AL102
AL102 is an investigational small molecule gamma secretase inhibitor (GSI) that is designed to potently and selectively inhibit Notch 1, 2, 3 and 4, and is currently being evaluated in the Phase 2/3 RINGSIDE clinical studies in patients with progressing desmoid tumors. AL102 is designed to inhibit the expression of Notch gene targets by blocking the final cleavage step by the gamma secretase required for Notch activation. Ayala obtained an exclusive, worldwide license to develop and commercialize AL102 from Bristol-Myers Squibb Company in November 2017. AL102 was granted U.S. FDA Fast Track Designation for the treatment of desmoid tumors.
About Biosight Ltd.
Biosight is a private clinical stage biotech company developing innovative therapeutics for hematological malignancies and disorders. Biosight’s lead product, aspacytarabine (BST-236), is an innovative proprietary anti-metabolite designed to address unmet medical needs by enabling high-dose chemotherapy with reduced systemic toxicity. For additional information, please visit www.biosight-pharma.com.
About Aspacytarabine (BST-236)
Aspacytarabine (BST-236) is being developed to serve as a superior novel backbone for acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS) therapy, either as a single agent or in combination with other therapies, including targeted therapy agents. Results from a recently completed Phase 2b study evaluating aspacytarabine as a single-agent first-line AML therapy demonstrate safety and impressive single-agent activity. Additional studies are ongoing to evaluate aspacytarabine in combination with venetoclax as a first-line treatment of AML, as well as a second line monotherapy for patients with relapsed or refractory MDS or AML. Aspacytarabine has been granted FDA Fast Track Designation for first-line treatment of AML patients unfit for standard chemotherapy, and Orphan Drug designations from the FDA and EMA in AML, as well as Orphan Drug designation in MDS from the FDA.
Contacts:
Ayala Pharmaceuticals:
+1-857-444-0553
[email protected]
Investors:
Tim McCarthy
LifeSci Advisors, LLC
[email protected]
917-679-9282
