Benzinga | Jul 6, 2021 06:04AM EDT

Advaxis And Biosight Announce Entry Into Merger Agreement; Biosight Shareholders To Become Majority Shareholders Of Combined Co., Combined Co. To Have $50M In Cash, Cash Equivalents And Marketable Securities

-- Combined Company Will Operate as Biosight Therapeutics to Advance Pipeline of Clinical-Stage Oncology Programs with Lead Program Aspacytarabine (BST-236) in Acute Myeloid Leukemia (AML) and Myelodysplastic Syndrome (MDS)



-- Combined Company Will be Well-Funded with Cash Position of approx.$50 Million Expected at Closing

-- Multiple Clinical and Regulatory Pipeline Milestones Planned for Combined Company Over the Next 12-18 Months

-- Companies to Host Joint Conference Call on Tuesday, July 6, 2021 at 8:30 am EDT

MONMOUTH JUNCTION, N.J. and AIRPORT CITY, Israel, July 06, 2021 (GLOBE NEWSWIRE) -- Advaxis, Inc. ("Advaxis") (NASDAQ:ADXS) and Biosight Ltd. ("Biosight"), a privately held pharmaceutical development company developing innovative therapeutics for hematological malignancies and disorders, today announced that the companies have entered into a definitive merger agreement pursuant to which the shareholders of Biosight will become the majority holders of the combined company immediately following completion of the transaction. The proposed merger will create a public company that will prioritize the clinical advancement and commercialization of Biosight's lead product, aspacytarabine (BST-236). The combined company is expected to have approximately $50 million in cash, cash equivalents and marketable securities at closing. Following the closing, which is expected to occur in the second half of 2021, Advaxis will be renamed Biosight Therapeutics and is expected to trade on the Nasdaq Capital Market under the ticker symbol "BSTX".

The combined company plans to advance its pipeline through multiple clinical trials, and anticipates the following milestones over the next 12-18 months:

* Topline results from the ongoing Phase 2 trial of aspacytarabine, which has completed enrolment, as first-line therapy in AML patients who are unfit for standard chemotherapy Recent data presented at ASCO showed that aspacytarabine achieved complete remission (CR) rates of 39% across all evaluable patients (n=46) with 63% of cases with negative minimal residual disease (MRD(-)) and median overall survival (OS) of 10 months at present (95% CI, 6- NR). Altogether these results are encouraging considering the high risk factors in this population at baseline;

* Results from the Phase 2 trial of aspacytarabine in collaboration with the European cooperative group, Groupe Francophone des My?lodysplasies (GFM) in patients with relapsed/refractory AML and higher-risk Myelodysplastic Syndrome (MDS);

* Initiation in the U.S. of a second, Phase 2 trial of aspacytarabine in patients with relapsed/refractory AML and higher-risk MDS;

* Results from the ongoing Phase 1/2 trial with ADXS-503 in combination with pembrolizumab in non-small cell lung cancer; and

* Results from the Phase 1 trial of ADXS-504 in biochemically recurrent prostate cancer

"After an extensive and thorough review of strategic and potentially transformative options for Advaxis, we are very pleased to announce a proposed merger with Biosight," said Kenneth A. Berlin, President, Chief Executive Officer and Interim Chief Financial Officer of Advaxis. "We believe the combined company's strong and diversified oncology pipeline with late stage and early stage assets, near-term milestones, seasoned leadership team and focus on both hematological malignancies and solid tumors have the potential to provide transformative benefits to patients while also providing value to our stockholders."

"The proposed merger with Advaxis is a unique opportunity for Biosight to build a leading public company in oncology, with a diversified clinical pipeline in both hematological malignancies and solid tumors. The combined company will have the demonstrated expertise and strong balance sheet to advance its lead programs towards multiple anticipated milestones over the next 12 to 18 months," said Dr. Ruth Ben Yakar, CEO of Biosight. "I would like to express my deepest appreciation to the wonderful Biosight team, including Dr. Liat Flaishon and Dr. Shoshi Tessler who lead our R&D activities, and Dr. Stela Gengrinovitch, the founder of the company. The excellent work and dedication of the entire Biosight team enabled the significant achievements. I would also like to thank our Board of Directors and Shareholders for their support over the years."

About the Proposed Merger

Pursuant to the merger agreement, Advaxis will acquire all of the outstanding share capital of Biosight in exchange for the issuance of newly issued shares of Advaxis common stock upon closing, subject to the satisfaction or waiver of customary closing conditions, including the receipt of the required approval of the Advaxis stockholders and Biosight stockholders and certain regulatory approvals. Upon completion of the merger, Advaxis's then-current equity holders will own approximately 25% and the former Biosight equity holders will own approximately 75% percent of Advaxis's common stock, calculated on a fully diluted basis.

The transaction has been unanimously approved by the board of directors of both companies. The combined company will be headquartered out of new facilities expected to be located in New Jersey and will continue to maintain its presence in Israel.

LifeSci Capital LLC acted as exclusive financial advisor to Advaxis. Morgan, Lewis & Bockius LLP and Herzog Fox & Neeman are serving as legal counsel to Advaxis. White & Case and Horn & Co. are serving as legal counsel to Biosight.

Management and Organization

Effective as of the closing of the transaction, Ken Berlin will be the President and Chief Executive Officer of the combined company. Senior leadership of the combined company will also include Roy Golan, as Chief Financial Officer, Andres Gutierrez, M.D., Ph.D., and Darrel Cohen, M.D., Ph.D. as Chief Medical Officers. Additionally, effective as of the closing of the merger, the Board of Directors of the combined company will be comprised of nine directors: six designated by Biosight and two to be designated by Advaxis, and Dr. David Sidransky will be nominated as Chairman of the Board.