MELBOURNE, Australia , Feb. 8, 2024 /PRNewswire/ –.Telix Prescription drugs Restricted (ASX: TLX, Telix, the Firm) right this moment pronounces it has entered into an settlement to accumulate QSAM Biosciences, Inc. (U.S. OTC: QSAM) and its lead investigational drug Samarium-153-DOTMP (153Sm-DOTMP). QSAM is a United States (U.S.) primarily based firm growing therapeutic radiopharmaceuticals for main and metastatic bone most cancers.
153Sm-DOTMP is a novel kit-based bone-seeking focused radiopharmaceutical candidate that makes use of a “subsequent technology” chelating agent to ship a proprietary formulation of Samarium-153 radioisotope. With two main potential purposes – ache administration of bone metastases and osteosarcoma remedy, together with in paediatric sufferers – 153Sm-DOTMP is very aligned with Telix’s current therapeutic focus areas in urologic oncology (prostate most cancers), neuro-oncology (glioma), and musculoskeletal oncology (sarcoma).
153Sm-DOTMP has proven in pre-clinical and early scientific trials proof of security, efficacy and future business utility, and has the potential to ship important enhancements on prior bone-seeking brokers within the remedy and administration of late-stage metastatic illness. This features a much-improved security profile (myelotoxicity and renal toxicity), extra focused supply (diminished off-target irradiation) and a streamlined manufacturing system (versatile provide chain and decrease COGS).[1] The potential commercialisation of this asset would construct on a well-established reimbursement pathway for this class of medicine, providing a possible cost-effective and high quality of life-enhancing various to standard-of-care (bisphosphonates, steroids, opioids).
Current pre-clinical and scientific knowledge have yielded encouraging proof for 153Sm-DOTMP to allow the ache administration of prostate most cancers bone metastases,[2] the place there stays a big unmet affected person want notably after development from different types of radionuclide and radiation remedy. Telix believes that 153Sm-DOTMP could profit sufferers with metastatic lung and breast most cancers, the place many sufferers develop mind and bone metastases, and illness administration usually focusses on quality-of-life palliative care.
153Sm-DOTMP has additionally been granted Orphan Drug[3] and Uncommon Pediatric Illness[4] Designations (ODD/RPDD) by the U.S. Meals and Drug Administration (FDA) for the remedy of osteosarcoma. This designation broadens Telix’s portfolio to incorporate potential remedy for a illness that largely impacts youngsters and younger adults, constructing upon Telix’s established focus in musculoskeletal oncology (the focused alpha program – TLX300 / olaratumab). The RPDD designation could allow 153Sm-DOTMP to be delivered to market extra quickly by regulatory incentives, together with eligibility for a paediatric uncommon illness Precedence Evaluate Voucher (PRV) that could be utilized to this or different Telix packages.
Dr Christian Behrenbruch, Managing Director and Group CEO of Telix stated, “The acquisition of QSAM offers Telix with an extra near-term therapeutic pipeline asset, additional differentiating our innovation place in radiopharmaceuticals and constructing depth in Telix’s key illness focus areas of urological and musculoskeletal oncology. Samarium is a extremely optimum radionuclide for treating bone metastases, and the mixture of ODD and PRDD standing with Telix’s demonstrated expertise in pharmacy-based cold-kit distribution has sturdy potential for a fast pathway to commercialisation of this asset.”
Deal phrases and circumstances
The acquisition value contains:
- US$33.1 million (AU$50.8 million[5]) upfront, which is payable within the type of 4,369,914 Telix atypical shares to be issued at closing, topic to sure money changes (at or after closing) which might be deducted off the upfront worth, and
- Contingent Worth Rights, or efficiency rights, that symbolize the correct of the holders to obtain contingent funds as much as 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 variety of atypical shares to be issued at closing shall be decided primarily based on a value per share, which represents the amount weighted common value at which the atypical shares traded on the ASX over the ten buying and selling day interval previous to signing.
Execution of the acquisition settlement concludes an choice interval of exclusivity and to finish diligence following the signing of a Time period Sheet for the proposed acquisition in November 2023.[7] Completion of the transaction is topic to customary circumstances, together with approval of QSAM’s stockholders and regulatory approvals.
Check with Telix disclosures and Appendix 3B lodged with the ASX right this moment for additional info.
About bone most cancers
Within the U.S., there are over 400,000 new sufferers recognized annually with metastatic bone most cancers and 350,000 affected person deaths.[8] The incidence of superior malignant tumours with bone metastasis might be as much as 70%, particularly frequent in sufferers with superior prostate and breast most cancers.[9] Osteosarcoma and Ewing’s sarcoma are the most typical malignancies of the bones in youngsters.
About QSAM Biosciences, Inc.
QSAM Biosciences, Inc. is growing next-generation nuclear medicines for the remedy of most cancers and different ailments. QSAM’s preliminary know-how, 153Sm-DOTMP, is a clinical-stage bone-targeting radiopharmaceutical initially developed by IsoTherapeutics Group LLC and now owned by IGL Pharma Inc.
About Telix Prescription drugs Restricted
Telix is a biopharmaceutical firm targeted on the event and commercialisation of diagnostic and therapeutic radiopharmaceuticals and related medical gadgets. Telix is headquartered in Melbourne, Australia with worldwide operations in the USA, Europe (Belgium and Switzerland), and Japan. Telix is growing a portfolio of clinical-stage merchandise that goals to deal with important unmet medical wants in oncology and uncommon ailments. Telix is listed on the Australian Securities Trade (ASX: TLX).
Go to www.telixpharma.com for additional details about Telix, together with particulars of the newest share value, bulletins made to the ASX, investor and analyst displays, information releases, occasion particulars and different publications that could be of curiosity. You may also observe Telix on X and LinkedIn.
Telix’s lead imaging product, gallium-68 (68Ga) gozetotide injection (often known as 68Ga PSMA-11 and marketed below the model identify Illuccix®), has been accredited by the FDA,[10] by the Australian Therapeutic Items Administration (TGA),[11] and by Well being Canada.[12]
Telix Investor Relations
Ms. Kyahn Williamson
Telix Prescription drugs Restricted
SVP Investor Relations and Company Communications
E-mail: [email protected]
This announcement has been authorised for launch by the Telix Prescription drugs Restricted Board.
Authorized Notices
This announcement shouldn’t be meant as promotion or promoting directed to any healthcare skilled or different viewers in any nation worldwide (together with Australia, United States and the United Kingdom). This announcement could embody forward-looking statements that relate to anticipated future occasions, monetary efficiency, plans, methods or enterprise developments. Ahead-looking statements can usually be recognized by means of phrases similar to “could”, “anticipate”, “intend”, “plan”, “estimate”, “anticipate”, “outlook”, “forecast” and “steerage”, or different related phrases. Ahead-looking statements contain identified and unknown dangers, uncertainties and different components which will trigger our precise outcomes, ranges of exercise, efficiency or achievements to vary materially from any future outcomes, ranges of exercise, efficiency or achievements expressed or implied by these forward-looking statements. Ahead-looking statements are primarily based on the Firm’s good-faith assumptions as to the monetary, market, regulatory and different dangers and issues that exist and have an effect on the Firm’s enterprise and operations sooner or later and there might be no assurance that any of the assumptions will show to be appropriate. Within the context of Telix’s enterprise, forward-looking statements could embody, however are usually not restricted to, statements about: the initiation, timing, progress and outcomes of Telix’s preclinical and scientific research, and Telix’s analysis and improvement packages; Telix’s skill to advance product candidates into, enrol and efficiently full, scientific research, together with multi-national scientific trials; the timing or probability of regulatory filings and approvals, manufacturing actions and product advertising actions; the commercialisation of Telix’s product candidates, if or once they have been accredited; estimates of Telix’s bills, future revenues and capital necessities; Telix’s monetary efficiency; developments regarding Telix’s rivals and trade; and the pricing and reimbursement of Telix’s product candidates, if and after they’ve been accredited. Telix’s precise outcomes, efficiency or achievements could also be materially totally different from these which can be expressed or implied by such statements, and the variations could also be opposed. Accordingly, you shouldn’t place undue reliance on these forward-looking statements.
Besides as required by relevant legal guidelines or laws, Telix doesn’t undertake to publicly replace or evaluation any forward-looking statements. Previous efficiency can’t be relied on as a information to future efficiency. Readers ought to learn this announcement along with our materials dangers, as disclosed in our most lately filed reviews with the ASX and on our web site.
©2024 Telix Prescription drugs Restricted and QSAM Biosciences, Inc.. The Telix Prescription drugs and Illuccix identify and brand are logos of Telix Prescription drugs Restricted and its associates. The QSAM Biosciences identify and brand are logos of QSAM Biosciences, Inc. All rights reserved.
[1] QSAM company presentation Q2 2023.
[2] QSAM media launch 16 August 2023.
[3] QSAM media launch 18 August 2021.
[4] QSAM media launch 2 February 2022.
[5] AUD/USD change price of 0.6522
[6] Check with Telix disclosures and Appendix 3B lodged with the ASX right this moment for additional particulars.
[7] Telix ASX disclosure 14 November 2023.
[8] Huang, J., et al., (2020). Incidence Of Sufferers with Bone Metastases At Prognosis Of Strong Tumors In Adults: A Giant Inhabitants-Based mostly Examine. Doi: 10.21037/atm.2020.03.55.
[9] Colsia, et al., (2022). The Burden of Metastatic Most cancers-Induced Bone Ache: A Narrative Evaluate. 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.
SOURCE Telix Prescription drugs Restricted
