Telix Announces Proposed Acquisition of QSAM Biosciences and Its Lead Therapy Candidate, CycloSam®

MELBOURNE, Australia, Nov. 13, 2023 /PRNewswire/ -- Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company) today announces it has signed a conditional Term Sheet to acquire QSAM Biosciences, Inc. (QSAM) and its lead asset, CycloSam^® (Samarium-153-DOTMP). QSAM is a United States (U.S.) based clinical stage company developing therapeutic radiopharmaceuticals for primary and metastatic bone cancer.

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.

About QSAM Biosciences, Inc.
QSAM Biosciences, Inc. is developing next-generation nuclear medicines for the treatment of cancer and other diseases. QSAM's initial technology, CycloSam® (Samarium-153 DOTMP), is a clinical-stage bone-targeting radiopharmaceutical developed by IsoTherapeutics Group LLC, pioneers in the nuclear medicine space who also developed the U.S. Food and Drug Administration (FDA) -approved Quadramet® (Samarium-153 EDTMP), which is indicated for bone cancer pain palliation.

About Telix Pharmaceuticals Limited
Telix is a biopharmaceutical company focused on the development and commercialisation of diagnostic and therapeutic radiopharmaceuticals and associated medical devices. Telix is headquartered in Melbourne, Australia with international operations in the United States, Europe (Belgium and Switzerland), and Japan. Telix is developing a portfolio of clinical-stage products that aims to address significant unmet medical needs in oncology and rare diseases. Telix is listed on the Australian Securities Exchange (ASX: TLX).

Visit www.telixpharma.com for further information about Telix, including details of the latest share price, announcements made to the ASX, investor and analyst presentations, news releases, event details and other publications that may be of interest. You can also follow Telix on LinkedIn.

Telix's lead product, gallium-68 (⁶⁸Ga) gozetotide (also known as ⁶⁸Ga PSMA-11) injection, has been approved by the U.S. FDA,^[7] by the Australian Therapeutic Goods Administration (TGA),^[8] and by Health Canada.^[9]

Telix Investor Relations
Ms. Kyahn Williamson
Telix Pharmaceuticals Limited
SVP Investor Relations and Corporate Communications
Email: kyahn.williamson@telixpharma.com

This announcement has been authorised for release by the Telix Pharmaceuticals Limited Disclosure Committee on behalf of the Board.

Legal Notices

This announcement is not intended as promotion or advertising directed to any healthcare professional or other audience in any country worldwide (including Australia, United States and the United Kingdom). This announcement may include forward-looking statements that relate to anticipated future events, financial performance, plans, strategies or business developments. Forward-looking statements can generally be identified by the use of words such as "may", "expect", "intend", "plan", "estimate", "anticipate", "outlook", "forecast" and "guidance", or other similar words. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance or achievements to differ materially from any future results, levels of activity, performance or achievements expressed or implied by these forward-looking statements. Forward-looking statements are based on the Company's good-faith assumptions as to the financial, market, regulatory and other risks and considerations that exist and affect the Company's business and operations in the future and there can be no assurance that any of the assumptions will prove to be correct. In the context of Telix's business, forward-looking statements may include, but are not limited to, statements about: the initiation, timing, progress and results of Telix's preclinical and clinical studies, and Telix's research and development programs; Telix's ability to advance product candidates into, enrol and successfully complete, clinical studies, including multi-national clinical trials; the timing or likelihood of regulatory filings and approvals, manufacturing activities and product marketing activities; the commercialisation of Telix's product candidates, if or when they have been approved; estimates of Telix's expenses, future revenues and capital requirements; Telix's financial performance; developments relating to Telix's competitors and industry; and the pricing and reimbursement of Telix's product candidates, if and after they have been approved. Telix's actual results, performance or achievements may be materially different from those which may be expressed or implied by such statements, and the differences may be adverse. Accordingly, you should not place undue reliance on these forward-looking statements.

Except as required by applicable laws or regulations, Telix does not undertake to publicly update or review any forward-looking statements. Past performance cannot be relied on as a guide to future performance. Readers should read this announcement together with our material risks, as disclosed in our most recently filed reports with the ASX and on our website.

©2023 Telix Pharmaceuticals Limited. The Telix Pharmaceuticals and Illuccix name and logo are trademarks of Telix Pharmaceuticals Limited and its affiliates (all rights reserved).

[1] Cleveland Clinic Journal of Medicine July 2022
[2] QSAM media release 18 August 2021.
[3] QSAM media release 2 February 2022.
[4] AUD/USD exchange rate of 0.64
[5] Huang, J., et al., (2020). Incidence Of Patients with Bone Metastases At Diagnosis Of Solid Tumors In Adults: A Large Population-Based Study. Doi: 10.21037/atm.2020.03.55.
[6] Colsia, et al., (2022). The Burden of Metastatic Cancer-Induced Bone Pain: A Narrative Review. Doi:10.2147/JPR.S371337.
[7] Telix ASX disclosure 20 December 2021.
[8] Telix ASX disclosure 2 November 2021.
[9] Telix ASX disclosure 14 October 2022.

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SOURCE Telix Pharmaceuticals Limited