FDA Accepts Telix NDA for New Prostate Cancer Imaging Agent

MELBOURNE, Australia, July 24, 2024  /PRNewswire/ -- Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company) today announces that the United States (U.S.) Food and Drug Administration (FDA) has accepted the filing of its New Drug Application (NDA) for TLX007-CDx, a new and proprietary cold kit ("Kit") for the preparation of PSMA-PET imaging^[1] for prostate cancer. The PDUFA^[2] goal date is March 24, 2025.

If approved, the new Kit will enable use of a PSMA imaging product with a considerably extended geographic distribution radius from a nuclear pharmacy compared to currently approved gallium-68 (⁶⁸Ga) based agents. Its innovative properties are designed to facilitate more flexible production, including with higher activity ⁶⁸Ga sourced from both newer high activity generators and cyclotrons powered by the ARTMS® QUANTM Irradiation System™^[3] and GE FASTlab™^[4] solid and liquid target production system. Through this NDA, Telix's objective is to further enhance patient access to PSMA-PET imaging and the clinical benefits of ⁶⁸Ga imaging to underserved populations across the U.S., using Telix's established nuclear pharmacy distribution partnerships and industry-leading on-time reliability.

PSMA-PET imaging represents a major advancement in prostate cancer management and in the U.S. has replaced conventional imaging methods (bone scan, CT scan) as the standard of care after initial diagnosis and biochemical recurrence^[5]. Despite this major medical advancement, only a relatively small fraction of the 3.4 million men living with prostate cancer in America have undergone a PSMA-PET imaging scan^[6],[7].

Dr Christian Behrenbruch, Managing Director and Group CEO of Telix stated, "We have seen rapid adoption and geographic expansion of PSMA-PET imaging with our first commercial product Illuccix®. This filing acceptance is an important step towards further improving equity of access and reinforcing our commitment to innovation in prostate cancer to continue to meet the needs of healthcare professionals and their patients. We now look forward to working with the FDA to bring TLX007-CDx to American men living with prostate cancer, including those residing in underserved communities and regions where access to state-of-the art imaging remains limited."

About Telix Pharmaceuticals Limited

Telix is a biopharmaceutical company focused on the development and commercialisation of therapeutic and diagnostic 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).

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^[8], by the Australian Therapeutic Goods Administration (TGA) ^[9], and by Health Canada^[10]. No other Telix product has received a marketing authorisation in any jurisdiction.

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 Investor RelationsMs. Kyahn WilliamsonTelix Pharmaceuticals LimitedSVP Investor Relations and Corporate CommunicationsEmail: kyahn.williamson@telixpharma.com

This announcement has been authorised for release by the Telix Pharmaceuticals Limited Disclosure Committee on behalf of the Board.

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® and Illuccix® names and logos are trademarks of Telix Pharmaceuticals Limited and its affiliates – all rights reserved.

[1] Imaging of prostate-specific membrane antigen with positron emission tomography.[2] Prescription Drug User Fee Act. [3] Telix ASX disclosure 11 April 2024. For further information visit: https://www.artms.ca/ [4] FASTlab is a trademark of GE Healthcare and its affiliates.[5] NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Prostate Cancer V.4.2024.[6] NIH Common Cancer Sites — Cancer Stat Facts. Accessed May 2024.[7] Company analysis based on proprietary and public domain data.[8] Telix ASX disclosure 20 December 2021.[9] Telix ASX disclosure 2 November 2021.[10] Telix ASX disclosure 14 October 2022.