On November 13, 2023 Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company) reported that it has signed a conditional Term Sheet to acquire QSAM Biosciences, Inc. (QSAM) and its lead asset, CycloSam (Samarium-153-DOTMP) (Press release, Telix Pharmaceuticals, NOV 13, 2023, View Source [SID1234637579]). QSAM is a United States (U.S.) based clinical stage company developing therapeutic radiopharmaceuticals for primary and metastatic bone cancer.

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CycloSam is highly synergistic with Telix’s existing therapeutic development activity in both prostate cancer and sarcoma. The proposed acquisition, subject to customary completion terms, will further enhance and differentiate Telix’s innovation position to provide a continuum of care to patients from diagnosis and staging, systemic treatment of metastatic disease, to palliative care.

With the broad success of immunotherapies and the more recent clinical impact of radiopharmaceutical therapies in diseases like prostate cancer, there is an unmet need to cost-effectively and safely manage pain from bone metastases in very late-stage patients. This unmet need is further exacerbated by the quality-of-life issues associated with metastatic pain management, particularly opioid administration. In the U.S. alone, there are an estimated 400,000 patients up-staged with malignant bone metastasis primarily from prostate, breast and lung cancer.[1]

In addition to near-term opportunities in metastatic disease management, the proposed acquisition may also broaden the Company’s pipeline depth in osteosarcoma, a disease that mostly affects children and young adults, where QSAM has received Orphan Drug[2] and Rare Pediatric[3] Disease Designations (RPDD) from the FDA. The RPDD designation may enable CycloSam to be brought to market more rapidly through additional incentives, including eligibility for a Priority Review Voucher (PRV) under which the FDA may reduce the review period for a drug candidate to six months.

Douglas Baum, QSAM CEO and Co-Founder said, "CycloSam is a novel, de-risked clinical asset that has the potential to deliver tangible improvements of prior bone-seeking agents with established efficacy, safety and commercial utility. By joining forces with Telix we are accessing a specialised commercial team, distribution network and development expertise, with the goal of realising the full potential of this asset."

Dr Christian Behrenbruch, Managing Director and Group CEO of Telix continued, "We are pleased to announce our intention to acquire QSAM. This acquisition will bring a validated therapeutic candidate with the potential to accelerate development under the Orphan Drug and Rare Pediatric Disease Designations, and a highly experienced team that has completed numerous FDA approvals.

With CycloSam we plan to leverage Telix’s extensive experience and success in distributing short-life radiopharmaceuticals using a cold kit product from a nuclear pharmacy. Given these factors, we see a strong pathway to commercialisation."

Deal terms and conditions
Upon signing of the Term Sheet, Telix has agreed to pay QSAM an upfront Collaboration and Option Fee of US$2 million (approximately AU$3.1 million)[4] to advance development efforts based on mutually agreed goals and to provide sixty days of exclusivity pending completion of diligence and execution of a definitive acquisition agreement (Purchase Agreement).

If the acquisition of QSAM proceeds, upon closing, Telix will pay a total purchase price of US$33.1 million in equity through the issue of fully paid ordinary Telix shares. Following closing, Telix will also pay up to US$90 million in contingent clinical and commercial milestone payments in cash or equity (at Telix’s election), subject to achievement and satisfactory completion of milestones, through a Contingent Value Rights structure. The Purchase Price constitutes approximately a 52% premium to QSAM’s fully diluted capitalisation for the 10 days prior to execution of the Term Sheet.

The execution of the Purchase Agreement and closing of the acquisition is subject to many conditions, including satisfactory completion of diligence by both parties and approval of QSAM shareholders. The material terms of the Term Sheet relating to the proposed acquisition of QSAM are subject to change.

If the proposed Acquisition of QSAM does not close, the Collaboration and Option Fee will be converted to QSAM common stock at US$6.70 per share.

About bone cancer
In the U.S., there are over 400,000 new patients diagnosed each year with metastatic bone cancer and 350,000 patient deaths.[5] The incidence of advanced malignant tumours with bone metastasis can be up to 70%, especially common in patients with advanced prostate and breast cancer.[6] Osteosarcoma and Ewing’s sarcoma are the most common malignancies of bone tissues in children. The current standard of care is aggressive and suboptimal, and has led to marginal success with significant side effects and poor long-term survival prognosis.