Thursday, February 08, 2024
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 Drug3 and Rare Pediatric Disease4 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:
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 Williamson
Telix Pharmaceuticals Limited
SVP Investor Relations and Corporate Communications