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Telix and Invicro Advance AI Partnership

MELBOURNE, Australia and BOSTON, June 14, 2022 /PRNewswire/ -- Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company) today announces that it has advanced a partnership with Invicro LLC (Invicro), a global, industry-leading imaging CRO, and part of REALM IDx, Inc., to develop an artificial intelligence (AI) platform to accompany Telix's PSMA-PET[1] imaging agent, Illuccix® (kit for the preparation of gallium Ga 68 gozetotide) - known as TelixAITM.

TelixAITM seeks to increase the efficiency and reproducibility of clinicians' imaging assessments using advanced analysis capabilities with an initial focus on prostate cancer. The platform is designed to do this by automatically separating healthy versus abnormal tracer uptake and then classifies lesions as either visceral (soft tissue) or bone lesions.

Invicro has a depth of experience in AI, machine learning and algorithm development for medical imaging. Its industry leading medical image analyst team consists of over fifty medical image processing scientists. The commercial objective of the development partnership is the submission to the United States Food and Drug Administration (FDA) 510(K) approval for software as a medical device.

A demonstration of the TelixAITM  was presented this week at the Society of Nuclear Medicine and Molecular Imaging (SNMMI) Annual Meeting being held in Vancouver, BC from June 11-14.

Telix Chief Scientist, Dr. Michael Wheatcroft said, "We are pleased to be advancing the TelixAITM platform with Invicro, which aims to further enhance the utility of molecular imaging starting with Illuccix. Our investment in TelixAITM is expected to extend into multiple applications for Telix's late-stage imaging assets, including TLX250-CDx, which is currently completing a Phase III pivotal trial in renal cancer imaging."

CEO of Invicro, Matt Silva, Ph.D., continued, "Invicro is delighted to bring our deep expertise in PET imaging, AI and machine learning and take this collaboration with Telix's Research and Innovation team into the next stage. We are excited about the possibility of bringing this software to realization with Illuccix and for the potential impact on clinicians' decision-making and patient outcomes with Telix's broad theranostic pipeline."

About Invicro

Headquartered in Needham, MA, Invicro, a part of REALM IDx, was founded in 2008 with the mission of improving the role and function of imaging in translational drug discovery and development across all therapeutic areas. Today, Invicro's multi-disciplinary team provides solutions to pharmaceutical and biotech companies across all stages of the drug development pipeline (Phase 0-IV), all imaging modalities and all therapeutic areas, including neurology, oncology, and systemic and rare diseases. Invicro's quantitative biomarker services, advanced analytics and AI tools, and clinical operational services are backed by Invicro's industry-leading software informatics platforms, VivoQuant® and iPACS®, as well as their pioneering IQ-Analytics Platform, which includes AmyloidIQ, TauIQ and DaTIQ.  

Invicro operates out of eight global laboratories, clinics and sites within the United States in Massachusetts, Michigan, California, Connecticut and globally in the United Kingdom, India and Japan. For more information visit www.invicro.com 

About Telix Pharmaceuticals Limited

Telix is a biopharmaceutical company focused on the development and commercialisation of diagnostic and therapeutic products using Molecularly Targeted Radiation (MTR). Telix is headquartered in Melbourne, Australia with international operations in Belgium, Japan, Switzerland, and the United States. Telix is developing a portfolio of clinical-stage products that address significant unmet medical need in oncology and rare diseases. Telix is listed on the Australian Securities Exchange (ASX: TLX). For more information visit www.telixpharma.com and follow Telix on Twitter (@TelixPharma) and LinkedIn.

Telix's lead product, gallium-68 (68Ga) gozetotide (also known as 68Ga PSMA-11) injection, has been approved by the U.S. Food and Drug Administration (FDA),[2] and by the Australian Therapeutic Goods Administration (TGA).[3] Telix is also progressing marketing authorisation applications for this investigational candidate in Europe[4] and Canada.[5] Illuccix is currently being investigated for use with Invicro's AI visual assessment software tool. 

Important Safety Information: https://www.illuccixhcp.com/important-safety-information

Please see full U.S. Prescribing Information at: http://illuccixhcp.com/s/illuccix-prescribing-information.pdf

Invicro Media Contact

Brad LottermanREALM IDx Communications DirectorEmail: blotterman@realmidx.com

Telix Investor Relations

Ms. Kyahn WilliamsonTelix Pharmaceuticals LimitedSVP Corporate Communications and Investor RelationsEmail: kyahn.williamson@telixpharma.com

This announcement has been authorised for release by Dr. Christian Behrenbruch, Managing Director and Group Chief Executive Officer.

Legal Notices

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 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.

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.  

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

[1] Prostate-specific membrane antigen-positron emission tomography.

[2] ASX disclosure 20 December 2021.

[3] ASX disclosure 2 November 2021.

[4] ASX disclosure 10 December 2021.

[5] ASX disclosure 16 December 2020.

 

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