MELBOURNE, Australia, April 26, 2023 - Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company) today announces the expansion of its artificial intelligence (AI) capability with the signing of an agreement to acquire Vienna-based Dedicaid GmbH (Dedicaid), a spin-off of the Medical University Vienna.
Dedicaid's core asset is a clinical decision support software (CDSS) AI platform capable of rapidly generating indication-specific CDSS applications from available datasets, for use with positron emission tomography (PET) and other imaging modalities. Each CDSS application is trained to predict outcomes such as the severity of disease, risk to the patient and/or inform treatment decisions.
The AI platform is also favourably differentiated from commercially-available AI solutions currently used in PSMA-PET imaging, which are limited to supporting clinicians in the interpretation and reading of images – without a prediction capability. This differentiation is driven by the Dedicaid developed AutoML (automated machine learning) engine behind the AI platform, effectively meaning it is a "zero code" solution. This greatly reduces the time, cost and level of expertise required to build, test and validate new CDSS applications, facilitating a streamlined development and regulatory pathway for each new application.
The technology has been developed by Dedicaid in collaboration with the Medical University Vienna, with proof of concept on the machine-learning methodology and applications developed for prostate, breast and lung cancer published in leading peer-review journals.[1]
The acquisition accelerates the development of Telix's AI platform – denoted as Telix AI™ – by adding predictive capabilities alongside the imaging analysis module, being developed in partnership with Invicro LLC,[2] which automates the classification of lesions to support greater efficiency and standardisation in the imaging workflow.
This acquisition will give Telix the ability to rapidly generate CDSS applications that are highly complementary to the Company's radiopharmaceutical pipeline. Following completion of the transaction, Telix aims to finalise validation activities and regulatory submissions (United States Food and Drug Administration (FDA) 510(k) and CE Mark (Europe)) for the AI platform as a 'software as a medical device' during 2023.
Dr Michael Wheatcroft, Chief Scientist at Telix said, "AI adds a new dimension of support to the clinician and patient by using data generated through medical imaging to facilitate timely and effective clinical decision making. This acquisition provides Telix with a powerful AI development platform that greatly enhances our ability to rapidly generate new applications from clinical imaging data. These applications have the potential to assist clinicians in predicting disease progression and treatment response, thus supercharging and differentiating Telix's AI offering. It is also intrinsically aligned to the philosophy behind theranostics - which is to use the insights from medical imaging to inform and guide an optimal treatment pathway."
Thomas Beyer, Co-founder and CEO of Dedicaid and Head of the Research Domain 'Quantitative Imaging and Medical Physics (QIMP)' of the Medical University Vienna said, "We have built the Dedicaid platform with the mission of enriching medical imaging with artificial intelligence in order to help clinicians navigate the complex task of diagnosing and treating cancer and deliver state-of-the-art patient care. After extensive research and validation, we are excited that Dedicaid will now become a part of Telix to complete the transition of this technology to commercial stage."
The purchase price is comprised of €1.1 million upfront, paid in equity, and a further €1.1 million earn-out subject to the achievement of regulatory approval in the U.S., and which is payable in cash or equity, at Telix's election. Telix will issue ordinary shares to the vendor within its Listing Rule 7.1 placement capacity as consideration for the acquisition. A proportion of each equity component will be subject to a 12-month escrow period. Following the acquisition, Telix will have ownership of all intellectual property related to the Dedicaid AI Platform.
About Telix Pharmaceuticals Limited
Telix is a biopharmaceutical company focused on the development and commercialisation of diagnostic and therapeutic radiopharmaceuticals. 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 need 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 Twitter (@TelixPharma) and LinkedIn.
Telix's lead product, Illuccix® (gallium-68 (68Ga) gozetotide (also known as 68Ga PSMA-11) injection), has been approved by the U.S. Food and Drug Administration (FDA),[3] and by the Australian Therapeutic Goods Administration (TGA),[4] and by Health Canada.[5] Telix is also progressing a marketing authorisation application for this investigational candidate in the United Kingdom.[6]
This announcement has been authorised for release by the Telix Pharmaceuticals Limited Disclosure Committee on behalf of the 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.
©2023 Telix Pharmaceuticals Limited. The Telix Pharmaceuticals and Illuccix name and logo are trademarks of Telix Pharmaceuticals Limited and its affiliates (all rights reserved).
[1] Papp, L et al. Journal of Nucl Med. 2018; Papp, L et al. European Journal of Nucl Med and Mol Imaging. 2021; Zhao, M et al. European Radiology. 2022; Krajnc, D et al. Cancers. 2021; Papp, L, Journal of Nucl Med. 2019.
[2] Telix media release 14 June 2022.
[3] Telix ASX disclosure 20 December 2021.
[4] Telix ASX disclosure 2 November 2021.
[5] Telix ASX disclosure 14 October 2022.
[6] Telix ASX disclosure 3 April 2023.
