Telix Signs Agreement to Acquire QSAM Biosciences and Its Bone Cancer Targeting Platform

MELBOURNE, Australia , Feb. 8, 2024 /PRNewswire/ --.Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company) today announces it has entered into an agreement to acquire QSAM Biosciences, Inc. (U.S. OTC: QSAM) and its lead investigational drug Samarium-153-DOTMP (¹⁵³Sm-DOTMP). QSAM is a United States (U.S.) based company developing therapeutic radiopharmaceuticals for primary and metastatic bone cancer.

¹⁵³Sm-DOTMP is a novel kit-based bone-seeking targeted radiopharmaceutical candidate that uses a "next generation" chelating agent to deliver a proprietary formulation of Samarium-153 radioisotope. With two major potential applications – pain management of bone metastases and osteosarcoma therapy, including in paediatric patients – ¹⁵³Sm-DOTMP is highly aligned with Telix's existing therapeutic focus areas in urologic oncology (prostate cancer), neuro-oncology (glioma), and musculoskeletal oncology (sarcoma).

¹⁵³Sm-DOTMP has shown in pre-clinical and early clinical trials evidence of safety, efficacy and future commercial utility, and has the potential to deliver significant improvements on prior bone-seeking agents in the treatment and management of late-stage metastatic disease. This includes a much-improved safety profile (myelotoxicity and renal toxicity), more targeted delivery (reduced off-target irradiation) and a streamlined production system (flexible supply chain and lower COGS).^[1] The potential commercialisation of this asset would build on a well-established reimbursement pathway for this class of drugs, offering a potential cost-effective and quality of life-enhancing alternative to standard-of-care (bisphosphonates, steroids, opioids).

Recent pre-clinical and clinical data have yielded encouraging evidence for ¹⁵³Sm-DOTMP to enable the pain management of prostate cancer bone metastases,^[2] where there remains a significant unmet patient need particularly after progression from other forms of radionuclide and radiation therapy. Telix believes that ¹⁵³Sm-DOTMP may benefit patients with metastatic lung and breast cancer, where many patients develop brain and bone metastases, and disease management often focusses on quality-of-life palliative care. 

¹⁵³Sm-DOTMP has also been granted Orphan Drug^[3] and Rare Pediatric Disease^[4] Designations (ODD/RPDD) by the U.S. Food and Drug Administration (FDA) for the treatment of osteosarcoma. This designation broadens Telix's portfolio to include potential treatment for a disease that mostly affects children and young adults, building upon Telix's established focus in musculoskeletal oncology (the targeted alpha program – TLX300 / olaratumab). The RPDD designation may enable ¹⁵³Sm-DOTMP to be brought to market more rapidly through regulatory incentives, including eligibility for a paediatric rare disease Priority Review Voucher (PRV) that may be applied to this or other Telix programs.

Dr Christian Behrenbruch, Managing Director and Group CEO of Telix said, "The acquisition of QSAM provides Telix with an additional near-term therapeutic pipeline asset, further differentiating our innovation position in radiopharmaceuticals and building depth in Telix's key disease focus areas of urological and musculoskeletal oncology. Samarium is a highly optimal radionuclide for treating bone metastases, and the combination of ODD and PRDD status with Telix's demonstrated experience in pharmacy-based cold-kit distribution has strong potential for a rapid pathway to commercialisation of this asset."

Deal terms and conditions

The purchase price comprises:

• US$33.1 million (AU$50.8 million^[5]) upfront, which is payable in the form of 4,369,914 Telix ordinary shares to be issued at closing, subject to certain cash adjustments (at or after closing) which would be deducted off the upfront value, and
• Contingent Value Rights, or performance rights, that represent the right of the holders to receive contingent payments up to US$90 million (AU$138 million^[5}) in the aggregate, which are payable in cash and/or in ordinary shares, upon achievement of certain clinical and commercial milestones.

Telix will issue ordinary shares to the stockholders of QSAM at closing within its Listing Rule 7.1 placement capacity as consideration for the acquisition. The ordinary shares issued upfront will be subject to escrow conditions.^[6] The number of ordinary shares to be issued at closing will be determined based on a price per share, which represents the volume weighted average price at which the ordinary shares traded on the ASX over the 10 trading day period prior to signing.

Execution of the acquisition agreement concludes an option period of exclusivity and to complete diligence following the signing of a Term Sheet for the proposed acquisition in November 2023.^[7] Completion of the transaction is subject to customary conditions, including approval of QSAM's stockholders and regulatory approvals.

Refer to Telix disclosures and Appendix 3B lodged with the ASX today for further information.

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.^[8] The incidence of advanced malignant tumours with bone metastasis can be up to 70%, especially common in patients with advanced prostate and breast cancer.^[9] Osteosarcoma and Ewing's sarcoma are the most common malignancies of the bones in children. 

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, ¹⁵³Sm-DOTMP, is a clinical-stage bone-targeting radiopharmaceutical originally developed by IsoTherapeutics Group LLC and now owned by IGL Pharma Inc.

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 X and LinkedIn.

Telix's lead imaging product, gallium-68 (⁶⁸Ga) gozetotide injection (also known as ⁶⁸Ga PSMA-11 and marketed under the brand name Illuccix^®), has been approved by the FDA,^[10] by the Australian Therapeutic Goods Administration (TGA),^[11] and by Health Canada.^[12]

Telix Investor Relations

Ms. Kyahn WilliamsonTelix Pharmaceuticals LimitedSVP Investor Relations and Corporate CommunicationsEmail: kyahn.williamson@telixpharma.com

This announcement has been authorised for release by the Telix Pharmaceuticals Limited 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.

©2024 Telix Pharmaceuticals Limited and QSAM Biosciences, Inc.. The Telix Pharmaceuticals and Illuccix name and logo are trademarks of Telix Pharmaceuticals Limited and its affiliates. The QSAM Biosciences name and logo are trademarks of QSAM Biosciences, Inc. All rights reserved.

[1] QSAM corporate presentation Q2 2023.[2] QSAM media release 16 August 2023.[3] QSAM media release 18 August 2021.[4] QSAM media release 2 February 2022.[5] AUD/USD exchange rate of 0.6522[6] Refer to Telix disclosures and Appendix 3B lodged with the ASX today for further details.[7] Telix ASX disclosure 14 November 2023.[8] 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.[9] Colsia, et al., (2022). The Burden of Metastatic Cancer-Induced Bone Pain: A Narrative Review. Doi:10.2147/JPR.S371337.[10] Telix ASX disclosure 20 December 2021.[11] Telix ASX disclosure 2 November 2021.[12] Telix ASX disclosure 14 October 2022.