Telix Pharmaceuticals Ltd.

LONDON, March 27, 2024 (GLOBE NEWSWIRE) -- Lightpoint Surgical Limited (Lightpoint), an affiliate of Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company) today announces a world-first bladder cancer sentinel lymph node (SLN) procedure with SENSEI®, Telix's miniature robotic-assisted gamma probe used to detect radiation in patients and guide surgery. The patient was operated on at Hospital del Mar in Barcelona, Spain. SENSEI® is smaller than an AA battery and designed specifically for robotic-assisted and minimally invasive surgery. The miniature size and proprietary features make the technology ideal for tight surgical spaces such as around the bladder. With broad application in radio-guided surgery across multiple procedures and major cancer types, SENSEI® is currently indicated for use during SLN biopsy in prostate, endometrial and cervical cancers. As part of an investigator-initiated clinical trial, SENSEI® was used by Dr. Lluís Cecchini with the da Vinci Xi surgical robotic platform in a patient scheduled for radical cystectomy and Bricker urinary diversion with SLN biopsy. Dr. Lluís Cecchini, Head of Urology at Hospital del Mar said, "Lymph nodes around the bladder have a high chance of being cancerous and are therefore important to excise. Radio-guided surgery has historically been limited by the fact that gamma probes are generally only suitable for open surgery. The size and flexibility of SENSEI® meant it was easy to manipulate within the surgical cavity, see the gamma signal within the robotic console, and quickly locate the SLN, where I might otherwise not have known it was present. Being able to perform the procedure with minimal impact on surrounding healthy tissue is a high surgical priority. With SENSEI® we can deliver a more targeted, focused, and less complex experience for patients." Nynke van den Berg, General Manager Medical Technologies (MedTech) at Telix added, “A first bladder cancer procedure with the SENSEI® drop-in gamma probe is a significant milestone for Telix and the Lightpoint team. As we focus on aligning SENSEI® with our Illuccix® and TLX599-CDx programs for prostate cancer, this successful procedure demonstrates the potential and scope to expand use into other urologic malignancies – in line with our portfolio approach to support the patient from diagnosis to surgical intervention and therapy.” About SENSEI® Lightpoint has developed SENSEI® - a miniaturised surgical gamma probe for minimally invasive and robot-assisted surgery. The device is approved for sale in the US, EU, UK, and Australia and is in clinical use in the US, UK, Germany, France, Netherlands, Belgium, and Spain. About Lightpoint Lightpoint Surgical Ltd (Lightpoint) is an affiliate of Telix Pharmaceuticals Limited. As the MedTech division of Telix, Lightpoint is focused on the development of precision-guided surgical solutions and complementary Artificial Intelligence technologies to aid detection, management and treatment of cancer and rare diseases. Lightpoint is headquartered in the United Kingdom. Telix Investor Relations Ms. Kyahn Williamson Telix Pharmaceuticals Limited SVP Investor Relations and Corporate Communications Email: kyahn.williamson@telixpharma.com 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, Lightpoint, Illuccix® and SENSEI® names and logos are trademarks of Telix Pharmaceuticals Limited and its affiliates – all rights reserved.

MELBOURNE, Australia, March 25, 2024 /PRNewswire/ -- Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company) today announces that the first patient has been dosed in its named patient program in Italy for TLX250-CDx (89Zr-DFO-girentuximab, Zircaix™[1]). TLX250-CDx is the Company's investigational non-invasive carbonic anhydrase IX (CAIX) targeting positron emission tomography (PET) imaging agent for clear cell renal cell carcinoma (ccRCC), the most common and aggressive form of kidney cancer. The first patient was dosed at IRCCS Ospedale San Raffaele in Milan, Italy. Through this program ('accesso allargato'), physicians may seek individual patient access to TLX250-CDx for use in PET characterisation of renal masses as ccRCC. This follows the completion of Telix's successful global Phase III ZIRCON study (Zirconium in Renal Cancer Oncology, ClinicalTrials.gov Identifier: NCT03849118), which reported positive results in November 2022, meeting all co-primary and secondary endpoints.[2] Arturo Chiti, Professor in Diagnostic Imaging and Radiotherapy at IRCCS Ospedale San Raffaele commented, "Continued access in Europe to TLX250-CDx is vitally important to enable early detection of ccRCC, which can often be challenging and reliant on invasive biopsy and nephrectomy (kidney removal). In TLX250-CDx, I am extremely pleased to be able to offer a non-invasive 'Molecular Biopsy™' to address unmet need in my patients in Italy." Frédéric Fantino, Telix Medical Director for the Europe, Middle East and Africa (EMEA) region continued, "We are pleased to support unmet patient need by adding a second European country to Telix's global expanded access program for TLX250-CDx. Through the ZIRCON study, this investigational agent has demonstrated high sensitivity and specificity in the detection of ccRCC with potential to change standard of care in the diagnosis and management of this most aggressive form of kidney cancer." In Italy, the use of a medicinal product in an individual patient prior to marketing authorisation and outside the context of a clinical trial is permitted in exceptional circumstances and regulated by the Ministry of Health. Italy becomes the third active country in Telix's global expanded access program, where first patients were dosed in the Netherlands[3] and the United States (U.S.)[4] in December 2023. Telix has commenced the regulatory filing for TLX250-CDx (Zircaix™[1]) with the U.S. Food and Drug Administration (FDA) under a Biologics License Application (BLA) rolling submission[5] and is progressing other equivalent applications with regulatory agencies in key commercial jurisdictions. Physicians in Europe who may have eligible patients can email [email protected] for further information about TLX250-CDx named patient access. For more information about ongoing clinical trials of TLX250-CDx, please visit Telix's Policy on Offering Compassionate Use to Investigational Medicines can be downloaded at the following link. 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 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. TLX250-CDx has not received a marketing authorisation in any jurisdiction. Telix's lead imaging product, gallium-68 (68Ga) gozetotide (also known as 68Ga PSMA-11) injection, has been approved by the FDA,[6] by the Australian Therapeutic Goods Administration (TGA),[7] and by Health Canada.[8] Telix Investor Relations Ms. Kyahn Williamson Telix Pharmaceuticals Limited SVP Corporate Communications and Investor Relations Email: [email protected] 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 Zircaix™[1] names and logos are trademarks of Telix Pharmaceuticals Limited and its affiliates – all rights reserved. [1] Trade name subject to final regulatory approval. [2] Telix ASX disclosure 7 November 2022. [3] Telix media release 4 December 2023. [4] Telix media release 11 December 2023. [5] Telix ASX disclosure 19 December 2023. [6] Telix ASX disclosure 20 December 2021. [7] Telix ASX disclosure 2 November 2021. [8] Telix ASX disclosure 14 October 2022. Logo -

MELBOURNE, Australia and DRESDEN, Germany, March 19, 2024 (GLOBE NEWSWIRE) -- 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 organization (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 personalized treatment regimens. Personalized radiopharmaceutical therapy administration based on individual patient dosimetry has the potential to improve clinical outcomes by optimizing treatment response while reducing effects on normal healthy organs and optimizing 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 personalized 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 commercialization 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 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’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 miniaturized surgical gamma probe, SENSEI®, for minimally invasive and robotic-assisted surgery, has attained a marketing authorization 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 authorization in any jurisdiction. Telix Investor Relations Ms. Kyahn Williamson Telix Pharmaceuticals Limited SVP Investor Relations and Corporate Communications Email: kyahn.williamson@telixpharma.com 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. 1 Telix ASX disclosure 20 December 2021. 2 Telix ASX disclosure 2 November 2021. 3 Telix ASX disclosure 14 October 2022.