Gallium GA-68 Gozetotide

MELBOURNE, Australia and INDIANAPOLIS, June 23, 2025 (GLOBE NEWSWIRE) -- Telix Pharmaceuticals Limited (ASX: TLX, NASDAQ: TLX, “Telix”, “the Company”) today announces that the United States (U.S.) Food and Drug Administration (FDA) has approved a label expansion for Illuccix® (kit for the preparation of gallium Ga-68 gozetotide, for injection) to include patient selection for radioligand therapy (RLT) in the pre-taxane setting. The update applies to Illuccix’s third indication, for selection of patients who are indicated for PSMA1-directed therapy as described in the Prescribing Information of the therapeutic products. The label expansion follows the FDA’s approval of an expanded label for Pluvicto®2 (lutetium Lu177 vipivotide tetraxetan) for use in metastatic castration-resistant prostate cancer (mCRPC) patients after treatment with androgen receptor pathway inhibitor (ARPI) therapy and before chemotherapy3. With RLT now approved for use earlier in the patient journey, the clinical utilization of Illuccix® is expected to increase by at least 20,000 scans annually4. Scott T. Tagawa, MD, a genitourinary (GU) oncologist in New York said, “It is pleasing to see the ability to use gallium-68 PSMA-PET for patient selection expanded. This empowers clinicians to make more informed, personalized decisions earlier in the disease course and access life-prolonging targeted radionuclide therapy for more patients with prostate cancer.” Kevin Richardson, Chief Executive Officer, Precision Medicine, Telix, said, “We’re pleased that the U.S. label for Illuccix has been expanded to support patient selection for RLT in the pre-taxane setting, aligning with the evolving treatment landscape. PSMA-PET imaging has become a standard of care in the detection and management of prostate cancer. With this update, patients can now benefit from the high diagnostic accuracy of Illuccix to identify those most likely to respond to PSMA-targeted therapy, even earlier in their treatment journey.” INDICATIONS AND USAGE Illuccix, after radiolabeling with Ga 68, is for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer: With suspected metastasis who are candidates for initial definitive therapy With suspected recurrence based on elevated serum prostate-specific antigen (PSA) levelFor selection of patients who are indicated for PSMA-directed therapy as described in the Prescribing Information of the therapeutic products IMPORTANT SAFETY INFORMATIONWARNINGS AND PRECAUTIONS Risk for MisinterpretationImage interpretation errors can occur with Illuccix PET. A negative image does not rule out the presence of prostate cancer, and a positive image does not confirm the presence of prostate cancer. Gallium Ga 68 gozetotide uptake is not specific for prostate cancer and may occur with other types of cancer as well as non-malignant processes such as Paget’s disease, fibrous dysplasia, and osteophytosis. Clinical correlation, which may include histopathological evaluation of the suspected prostate cancer site, is recommended. Imaging Prior to Initial Definitive or Suspected Recurrence TherapyThe performance of Illuccix for imaging of biochemically recurrent prostate cancer seems to be affected by serum PSA levels and by site of disease. The performance of Illuccix for imaging of metastatic pelvic lymph nodes prior to initial definitive therapy seems to be affected by Gleason score. Radiation RisksGallium Ga 68 gozetotide contributes to a patient’s overall long-term cumulative radiation exposure. Long-term cumulative radiation exposure is associated with an increased risk for cancer. Ensure safe handling to minimize radiation exposure to the patient and healthcare providers. Advise patients to hydrate before and after administration and to void frequently after administration. ADVERSE REACTIONSThe safety of gallium Ga 68 gozetotide was evaluated in 960 patients in the PSMA-PreRP and PSMA-BCR studies, each receiving one dose of gallium Ga 68 gozetotide. The average injected activity was 188.7 ± 40.7 MBq (5.1 ± 1.1 mCi). The most commonly reported adverse reactions were nausea, diarrhea, and dizziness, occurring at a rate of <1%.In the VISION study, 1003 patients received one dose of gallium Ga 68 gozetotide intravenously with the amount of radioactivity 167.1 ± 23.1 MBq (4.52 ± 0.62 mCi). Adverse reactions occurring at ≥0.5% in patients with metastatic prostate cancer who received gallium Ga 68 gozetotide injection in the clinical study were fatigue (1.2%), nausea (0.8%), constipation (0.5%), and vomiting (0.5%). Adverse reactions occurring at a rate of < 0.5% in the VISION study were diarrhea, dry mouth, injection site reactions, including injection site hematoma and injection site warmth and chills. DRUG INTERACTIONSAndrogen deprivation therapy and other therapies targeting the androgen pathwayAndrogen deprivation therapy (ADT) and other therapies targeting the androgen pathway, such as androgen receptor antagonists, can result in changes in uptake of gallium Ga 68 gozetotide in prostate cancer. The effect of these therapies on performance of gallium Ga 68 gozetotide PET has not been established. Please note that this information is not comprehensive.Please see the Full Prescribing Information here. You are encouraged to report suspected adverse reactions of prescription drugs to the FDA. Visit MedWatch at www.fda.gov/medwatch or call 1-800-FDA-1088. You may also report adverse reactions to Telix by calling 1-844-455-8638 or emailing: pharmacovigilance@telixpharma.com. Dr. Tagawa has served as a paid consultant to Telix and his institution has received research funding. Telix Investor Relations Ms. Kyahn WilliamsonTelix Pharmaceuticals LimitedSVP Investor Relations and Corporate CommunicationsEmail: kyahn.williamson@telixpharma.com Telix Media Relations (U.S.) Eliza Schleifstein ES Media Relations Email: eliza@schleifsteinpr.com Phone: 917-763-8106 About Telix Pharmaceuticals Limited Telix is a biopharmaceutical company focused on the development and commercialization of therapeutic and diagnostic radiopharmaceuticals and associated medical technologies. Telix is headquartered in Melbourne, Australia, with international operations in the United States, Brazil, Canada, 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) and the Nasdaq Global Select Market (NASDAQ: TLX). Illuccix® (kit for the preparation of gallium-68 (68Ga) gozetotide injection), Telix’s first generation PSMA-PET imaging agent, is approved and commercially available in multiple countries globally. Gozellix® (kit for the preparation of gallium-68 (68Ga) gozetotide injection) has been approved by the U.S. FDA5. Visit www.telixpharma.com for further information about Telix, including details of the latest share price, ASX and SEC filings, investor and analyst presentations, news releases, event details and other publications that may be of interest. You can also follow Telix on LinkedIn, X and Facebook. Legal Notices You should read this announcement together with our risk factors, as disclosed in our most recently filed reports with the Australian Securities Exchange (ASX), U.S. Securities and Exchange Commission (SEC), including our Annual Report on Form 20-F filed with the SEC, or on our website. The information contained in this announcement is not intended to be an offer for subscription, invitation or recommendation with respect to securities of Telix Pharmaceuticals Limited (Telix) in any jurisdiction, including the United States. The information and opinions contained in this announcement are subject to change without notification. To the maximum extent permitted by law, Telix disclaims any obligation or undertaking to update or revise any information or opinions contained in this announcement, including any forward-looking statements (as referred to below), whether as a result of new information, future developments, a change in expectations or assumptions, or otherwise. 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. This announcement may contain forward-looking statements, including within the meaning of the U.S. Private Securities Litigation Reform Act of 1995, 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”, “believe”, “outlook”, “forecast” and “guidance”, or the negative of these words or other similar terms or expressions. 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 Telix’s good-faith assumptions as to the financial, market, regulatory and other risks and considerations that exist and affect Telix’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 trials, 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 for Telix’s product candidates, manufacturing activities and product marketing activities; Telix’s sales, marketing and distribution and manufacturing capabilities and strategies; the commercialization of Telix’s product candidates, if or when they have been approved; Telix’s ability to obtain an adequate supply of raw materials at reasonable costs for its products and product candidates; estimates of Telix’s expenses, future revenues and capital requirements; Telix’s financial performance; developments relating to Telix’s competitors and industry; the anticipated impact of U.S. and foreign tariffs and other macroeconomic conditions on Telix’s business; 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. ©2025 Telix Pharmaceuticals Limited. Telix Pharmaceuticals®, Telix Group company, and Telix product names and logos are trademarks of Telix Pharmaceuticals Limited and its affiliates – all rights reserved. Trademark registration status may vary from country to country. _________________________1 Prostate-specific membrane antigen2 Pluvicto is a registered trademark of Novartis AG and/or its affiliates.3 28 March 2025, FDA Statement: for patients who have been treated with ARPI therapy and are considered appropriate to delay taxane-based chemotherapy.4 Based on licensed indication for Pluvicto in mCRPC patients who have been treated with androgen receptor (AR) pathway inhibition​.5 Telix ASX disclosure 21 March 2025.

MELBOURNE, Australia and INDIANAPOLIS, June 20, 2025 (GLOBE NEWSWIRE) -- Telix Pharmaceuticals Limited (ASX: TLX, NASDAQ: TLX, “Telix”, “the Company”) today announces it has launched a novel PET1 radiochemistry solution based on 18F-aluminium fluoride (AlF), named AlFluor™. The AlFluor™ platform technology enables flexible radiolabeling of PSMA2 with either AlF or gallium-68 (68Ga). It also has the potential to be used with ligands targeting NETs3 and FAP4, as well as other novel imaging agents under development by Telix and its strategic partners. Developed to combine the imaging benefits of 18F with the convenience of 68Ga kit-based workflows, the AlFluor™ platform supports both centralized cyclotron manufacturing and distributed "shake-and-inject" kit production. This flexibility allows a complementary product with the same targeting agent to be labeled with either isotope, catering to clinical setting or physician preference. As part of AlFluor’s development, Telix has signed a strategic agreement with University Hospital Ghent and Ghent University for a novel [18F]AlF-PSMA-11 targeting agent. The agreement includes a comprehensive chemistry, manufacturing and controls (CMC) package suitable for the preparation of a Drug Master File (DMF), and provides exclusive access to [18F]AlF-PSMA-11 clinical safety and efficacy data, including a Phase 3 trial in 96 prostate cancer patients, where PSMA-11 (gozetotide) was labeled interchangeably with 18F and 68Ga. The trial demonstrated diagnostic performance comparable to commercial 68Ga-labeled PSMA-11 agents such as Illuccix® and Gozellix®, both known to deliver high specificity (~90%) for metastatic detection at initial staging5. [18F]AlF-PSMA-11 has also demonstrated favorable biodistribution, high tumor-to-background ratios, and low off-target uptake in multiple studies6. Telix has commenced engagement with regulators to determine the pathway to approval for [18F]AlF-PSMA-11. Kevin Richardson, Chief Executive Officer, Telix Precision Medicine, said, “Telix’s goal is to expand the utilization of PSMA-PET imaging through clinical leadership and novel, flexible product deployment that enables physician choice. AlFluor™ is an example of innovation that meets the evolving needs of physicians and their patients. The addition of this advanced-stage technology and product candidate aligns with our strategy to offer the broadest choice of PSMA-PET imaging agents, with the service, flexibility and reliability that define the Telix customer experience.” About Telix Pharmaceuticals Limited Telix is a biopharmaceutical company focused on the development and commercialization of therapeutic and diagnostic radiopharmaceuticals and associated medical technologies. Telix is headquartered in Melbourne, Australia, with international operations in the United States, Brazil, Canada, 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) and the Nasdaq Global Select Market (NASDAQ: TLX). Illuccix® (kit for the preparation of gallium-68 (68Ga) gozetotide injection), Telix’s first generation PSMA-PET imaging agent, has been approved in multiple countries globally. Gozellix® (kit for the preparation of gallium-68 (68Ga) gozetotide injection) has been approved by the U.S. FDA7. Visit www.telixpharma.com for further information about Telix, including details of the latest share price, ASX and SEC filings, investor and analyst presentations, news releases, event details and other publications that may be of interest. You can also follow Telix on LinkedIn, X and Facebook. Telix Investor Relations Ms. Kyahn WilliamsonTelix Pharmaceuticals LimitedSVP Investor Relations and Corporate CommunicationsEmail: kyahn.williamson@telixpharma.com Telix Investor Relations (U.S.) Annie KasparianTelix Pharmaceuticals LimitedDirector Investor Relations and Corporate CommunicationsEmail: annie.kasparian@telixpharma.com Telix Media Relations (U.S.) Eliza Schleifstein ES Media Relations Email: eliza@schleifsteinpr.com Phone: 917-763-8106 Legal Notices You should read this announcement together with our risk factors, as disclosed in our most recently filed reports with the Australian Securities Exchange (ASX), U.S. Securities and Exchange Commission (SEC), including our Annual Report on Form 20-F filed with the SEC, or on our website. The information contained in this announcement is not intended to be an offer for subscription, invitation or recommendation with respect to securities of Telix Pharmaceuticals Limited (Telix) in any jurisdiction, including the United States. The information and opinions contained in this announcement are subject to change without notification. To the maximum extent permitted by law, Telix disclaims any obligation or undertaking to update or revise any information or opinions contained in this announcement, including any forward-looking statements (as referred to below), whether as a result of new information, future developments, a change in expectations or assumptions, or otherwise. 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. This announcement may contain forward-looking statements, including within the meaning of the U.S. Private Securities Litigation Reform Act of 1995, 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”, “believe”, “outlook”, “forecast” and “guidance”, or the negative of these words or other similar terms or expressions. 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 Telix’s good-faith assumptions as to the financial, market, regulatory and other risks and considerations that exist and affect Telix’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 trials, 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 for Telix’s product candidates, manufacturing activities and product marketing activities; Telix’s sales, marketing and distribution and manufacturing capabilities and strategies; the commercialization of Telix’s product candidates, if or when they have been approved; Telix’s ability to obtain an adequate supply of raw materials at reasonable costs for its products and product candidates; estimates of Telix’s expenses, future revenues and capital requirements; Telix’s financial performance; developments relating to Telix’s competitors and industry; the anticipated impact of U.S. and foreign tariffs and other macroeconomic conditions on Telix’s business; 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. ©2025 Telix Pharmaceuticals Limited. Telix Pharmaceuticals®, Telix Group company, and Telix product names and logos are trademarks of Telix Pharmaceuticals Limited and its affiliates – all rights reserved. Trademark registration status may vary from country to country. ______________________________________________1 Positron emission tomography.2 Prostate-specific membrane antigen.3 Neuroendocrine tumors.4 Fibroblast activation protein.5 PSMA-PreRP clinical study. ClinicalTrials.gov ID: NCT02919111.6 Piron et al. Sci Rep. 2021; Malik et al. EJNMMI Res. 2020; Boschi et al. EJNMMI Res. 2020.7 Telix ASX disclosure 21 March 2025.