Fortress Biotech to Fully Acquire Caelum Biosciences

According to the DOSPA, Alexion will purchase all of Caelum's outstanding shares and pay Caelum the agreed option exercise price of roughly 150 million dollars upon the acquisition's completion, which is scheduled on October 5, 2021.

FREMONT, CA: "The acquisition of Caelum is a positive development and monetization opportunity for our shareholders, while validating the Fortress business model. We believe in CAEL-101s potential to be a best-in-class treatment for AL amyloidosis and look forward to the continued progression of CAEL-101 in the CARES Phase 3 clinical program under the leadership of the renowned team at Alexion," states Lindsay A. Rosenwald, M.D., Chairman, President, and Chief Executive Officer, Fortress. Fortress Biotech, a revolutionary biopharmaceutical company focused on acquiring, expanding and commercializing or monetizing hopeful biopharmaceutical products and product candidates cost-efficiently, and a firm it founded, Caelum Biosciences (Caelum), a clinical-stage biotechnology business developing treatments for rare and life-threatening diseases, said that AstraZeneca's Alexion notified Caelum that it had exercised its option to acquire Caelum, under the Development, Option and Stock Purchase Agreement in place between Fortress, Alexion, Caelum, and the other parties thereto (as amended, the DOSPA). In addition, the Hart-Scott-Rodino (HSR) Antitrust Improvements Act of 1976, as modified, waiting period for such an acquisition has expired. One of the criteria antecedent for the closing of the purchase is the expiration of the waiting period under the HSR Act.

According to the DOSPA, Alexion will purchase all of Caelum's outstanding shares and pay Caelum the agreed option exercise price of roughly 150 million dollars upon the acquisition's completion, which is scheduled on October 5, 2021. All existing Caelum stockholders will receive distributions. Additional potential payments to Caelum stockholders of up to 350 million dollars are also included in the agreement, which is contingent on regulatory and commercial milestones being met. Fortress is eligible to collect about 43 percent of the transaction's total proceeds.

Michael Spector, Co-Founder, President, and Chief Executive Officer of Caelum, said, "I am proud to have been a co-founder of Caelum in 2017 with Fortress Biotech. Caelum formed a collaboration with Alexion Pharmaceuticals in 2019 to develop CAEL-101 for patients with AL amyloidosis, and we achieved significant milestones together through the on-going Phase 3 program. The acquisition of Caelum is an important step for patients with AL amyloidosis, as our partners at Alexion have the resources required to expedite the development of CAEL-101. Treatments that target amyloid deposits remain an important unmet medical need."

CAEL-101 is being evaluated in two concurrent Phase 3 studies, one in patients with Mayo stage IIIa disease and the other in those with Mayo stage IIIb illness, as part of the Cardiac Amyloid Reaching for Extended Survival (CARES) clinical program. In addition, the business is conducting a Phase 2 clinical trial to assess the safety and tolerability of CAEL-101 in individuals with AL amyloidosis (ClinicalTrials.gov Identifier: NCT04304144).