QDOSE® Platform Partnership for Personalised Dosimetry in Radiopharmaceutical Therapy

MELBOURNE, Australia and DRESDEN, Germany, March 19, 2024 /PRNewswire/ -- Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company) today announces that it has entered into an agreement to commercially partner the QDOSE® dosimetry software platform with ABX-CRO Advanced Pharmaceutical Services Forschungsgesellschaft mbH (ABX-CRO), a full-service contract research organisation (CRO) based in Dresden, and its development partner, Stockholm-based Quantinm AB.

QDOSE® is a validated, versatile software platform that enables reliable estimation of patient-specific dosimetry for both therapeutic and diagnostic radiopharmaceuticals. Telix intends to integrate the QDOSE® platform into its therapeutic radiopharmaceutical programs and clinical collaborations to enable the development of personalised treatment regimens. Personalised radiopharmaceutical therapy administration based on individual patient dosimetry has the potential to improve clinical outcomes by optimising treatment response while reducing effects on normal healthy organs and optimising the use of isotope supply chains.

QDOSE® supports dosimetry calculations using planar imaging, tomographic imaging, single/multi time point imaging and hybrid combinations. QDOSE® incorporates additional tools for attenuation and background correction. The QDOSE® platform will be integrated with Telix's artificial intelligence (AI) products as an accessible tool for clinicians and third-party commercial drug developers. QDOSE® has received 510(k) clearance from the United States Food and Drug Administration (FDA) and is Conformité Européenne (CE) marked for clinical use within the European Union (EU).

Dr Christian Behrenbruch, Managing Director and Group CEO of Telix said, "In nuclear medicine, dosimetry analysis is used to calculate the absorbed dose of radiation received by different parts of the body. Rapid, reliable and personalised dosimetry is becoming an increasingly important future direction of cancer care and regulatory authorities now expect to see dosimetry analysis. QDOSE® has an excellent performance track record and we are committed to positioning QDOSE® as a new industry standard in dosimetry analysis."

The arms' length up-front transaction consideration is non-material. Telix will pay undisclosed product royalties and fees on product sales.

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 and commercial 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^[1] 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^[2].

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,^[1] by the Australian Therapeutic Goods Administration (TGA),^[2] and by Health Canada.^[3] Telix's miniaturised surgical gamma probe, SENSEI®, for minimally invasive and robotic-assisted surgery, has attained a marketing authorisation in the U.S., having been registered with the FDA and has attained a CE Mark for use in the European Economic Area for the intra-operative detection of sentinel lymph nodes. With the exception of Illuccix® and SENSEI® as noted above, no Telix product has received a marketing authorisation in any jurisdiction.

Telix Investor Relations

Ms. Kyahn WilliamsonTelix Pharmaceuticals LimitedSVP Investor Relations and Corporate CommunicationsEmail: kyahn.williamson@telixpharma.com^[3]

Legal Notices

The information contained in this announcement is not intended to be an offer for subscription, invitation or recommendation with respect to shares of Telix Pharmaceuticals Limited (Telix) in any jurisdiction, including the United States. No representation or warranty, express or implied, is made in relation to the accuracy or completeness of the information contained or opinions expressed in the course of this announcement. The information contained in this announcement is subject to change without notification.

This announcement may contain 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. You should read this announcement together with our risk factors, as disclosed in our most recently filed reports with the ASX or on our website.

To the maximum extent permitted by law, Telix disclaims any obligation or undertaking to publicly update or revise any forward-looking statements contained in this announcement, whether as a result of new information, future developments or a change in expectations or assumptions.

©2024 Telix Pharmaceuticals Limited. The Telix Pharmaceuticals, Illuccix® and SENSEI® names and logos are trademarks of Telix Pharmaceuticals Limited and its affiliates – all rights reserved.

References

1. ^{^} www.telixpharma.com (www.telixpharma.com)
2. ^{^} LinkedIn (www.linkedin.com)
3. ^{^} kyahn.williamson@telixpharma.com (www.prnasia.com)