• Completed enrollment of 105 patients in Phase 3 registration study of TLX591-Px (Illuccix^®) for prostate cancer imaging in Japan.
• The study data will be used to support a New Drug Application (NDA) for TLX591-Px in Japan.

MELBOURNE, Australia and TOKYO, July 17, 2026 /PRNewswire/ — Telix Pharmaceuticals (ASX: TLX, NASDAQ: TLX, “Telix”) today announced completion of patient enrollment in the pivotal Phase 3 registration study of TLX591-Px (Illuccix^®, Kit for the preparation of ⁶⁸Ga-PSMA-11^[1]) for prostate cancer imaging in Japanese patients.

Illuccix Japan^[2] is a Phase 3 prospective, open-label, multicenter study designed to evaluate the detection efficacy and safety profile of ⁶⁸Ga-PSMA-11 PET/CT^[3] in Japanese patients with biochemically recurrent (BCR) prostate cancer following prior radical prostatectomy. The primary objective of the study is to compare the sensitivity of ⁶⁸Ga-PSMA-11 PET/CT with conventional imaging modalities, including CT and bone scintigraphy, for the detection of metastatic lesions. Secondary objectives include evaluating diagnostic performance for local and distant lesions, safety and tolerability, and the impact of imaging findings on clinical management decisions.

Telix is preparing an NDA for submission in Japan, with clinical data from the Phase 3 local study intended to support the application. In parallel, Telix’s application for Conditional Approval is under review by the Japan’s Pharmaceuticals and Medical Devices Agency (PMDA). If granted, Conditional Approval will enable an expedited NDA review process while the final study clinical dataset is prepared.                           

Completion of enrollment represents a significant milestone for the study and advances Telix’s registration strategy for Illuccix^® in Japan, one of the world’s largest nuclear medicine markets. The study complements Telix’s early access and broader prostate cancer portfolio activities in Japan, including named patient use for TLX591-Px^[4] and patient enrollment in the Phase 3 ProstACT Global study of TLX591-Tx (lutetium (¹⁷⁷Lu) rosopatamab tetraxetan)^[5] in advanced prostate cancer.

David N. Cade, MD, Group Chief Medical Officer, Telix, said, “Completion of patient enrollment into this pivotal Phase 3 study was rapid and represents a significant step towards the registration of Illuccix in Japan. We are grateful to the patients, investigators and dedicated study teams across the 11 sites for their commitment to this important study. Together, our goal is to expand access for Japanese men to the benefits of PSMA-PET imaging and thus improve outcomes for men in Japan living with prostate cancer.”

About Prostate Cancer in Japan

The Asia Pacific region comprises approximately one-third of the world’s male population and includes many nations whose populations are ageing or increasingly adopting a more affluent, ‘Western-style’ lifestyle, the two main demographic trends driving increasing cancer incidence rates. Consequently, the incidence of prostate cancer is increasing in many parts of the region. Prostate cancer is the most common cancer in Japanese men with more than 104,000 new diagnoses each year, and the sixth leading cause of cancer-related death with over 14,000 deaths annually^[6].

About Telix Pharmaceuticals Limited

Telix Pharmaceuticals (ASX: TLX, NASDAQ: TLX) is a commercial-stage global radiopharmaceutical company, advancing targeted theranostics to improve outcomes for people with cancer across the patient journey. Theranostics pairs a precision diagnostic with a targeted therapy to both diagnose and treat disease. 

Telix’s commercial franchise is anchored by its prostate cancer imaging portfolio: Illuccix^® (kit for the preparation of gallium-68 gozetotide injection), commercially available in 22 countries including the U.S. and Gozellix^® (kit for the preparation of gallium-68 gozetotide injection), Telix’s next-generation PSMA-PET imaging agent approved by the U.S. FDA. The Company’s late-stage therapeutic pipeline includes three assets in pivotal-stage trials – TLX591-Tx (lutetium-177 (¹⁷⁷Lu) rosopatamab tetraxetan) in prostate cancer, TLX101-Tx (¹³¹I-iodofalan) in recurrent glioblastoma, TLX250-Tx (¹⁷⁷Lu-girentuximab) in kidney cancer, complemented by a deep pipeline of next generation assets.

Telix is headquartered in Melbourne, Australia, with operations across North America, Europe, Latin America and Asia-Pacific. For more information, visit www.telixpharma.com or follow Telix on LinkedIn, X and Facebook.

Telix Contacts

Legal Notices

Cautionary Statement Regarding Forward-Looking Statements.  

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, completion and results of Telix’s preclinical and clinical trials, and Telix’s research and development programs; Telix’s ability to advance product candidates into, enroll 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, including as a result of war or other geopolitical conflicts; 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.

Trademarks and Trade Names. All trademarks and trade names referenced in this press release are the property of Telix Pharmaceuticals Limited (Telix) or, where applicable, the property of their respective owners. For convenience, trademarks and trade names may appear without the ^® or ™ symbols. Such omissions are not intended to indicate any waiver of rights by Telix or the respective owners. Trademark registration status may vary from country to country. Telix does not intend the use or display of any third-party trademarks or trade names to imply any affiliation with, endorsement by, or sponsorship from those third parties.

©2026 Telix Pharmaceuticals Limited. All rights reserved.

AUSTIN, Texas, July 17, 2026 /PRNewswire/ — Saronic today announced it has selected Brownsville, Texas as the future home of Port Alpha, its next-generation shipyard designed to help restore American maritime strength and significantly expand the nation’s shipbuilding capacity.

The announcement marks a major milestone in Saronic’s mission to restore U.S. shipbuilding capacity at scale. First introduced as a vision for the future of maritime manufacturing, Port Alpha now moves from concept to reality through a planned investment of more than $3 billion that aims to establish one of the most advanced shipyards in the world, built for software-defined shipbuilding and autonomous maritime systems.

The project is expected to generate more than $160 billion in regional economic impact for Cameron County and $264.5 billion for the State of Texas, while creating up to 10,000 direct jobs. This makes Port Alpha one of the largest economic development projects in modern Texas history. Construction is anticipated to begin in 2026, with Port Alpha expected to open for operations in 2028.

The timing is pivotal. In one of his first actions in office, President Trump issued an Executive Order on Restoring America’s Maritime Dominance, followed by federal initiatives such as the SHIPS for America Act and the Maritime Action Plan that call for a generational rebuild of the American shipbuilding industry. These efforts recognize that economic security and national security are inseparable, and that restoring U.S. shipbuilding capacity is essential to both. Port Alpha will expand domestic production capacity and strengthen the nation’s ability to meet commercial and defense requirements while closing the widening shipbuilding gap with foreign adversaries.

“America’s maritime future depends on our ability to build again,” said Dino Mavrookas, Co-Founder and CEO of Saronic. “Port Alpha is our commitment to that mission. Built from the ground up to deliver ships at a speed and scale not seen since World War II, this investment is about more than constructing a shipyard. It is about rebuilding the industrial capacity, workforce, and manufacturing advantage required to ensure American maritime leadership for decades to come. The state of Texas and city of Brownsville give us the foundation to turn that vision into reality.”

Following a year-long nationwide search evaluating sites across the East, West, and Gulf Coasts, Brownsville was selected after a rigorous review of workforce availability, infrastructure readiness, land scale, logistics, and expansion potential. Initially situated on 835 acres at the Port of Brownsville, with the opportunity to expand to nearly 4,400 acres, Port Alpha will encompass a shipyard and manufacturing facility capable of producing vessels up to 850-ft. Future site expansion could support the production of vessels over 1,200 ft. The site provides hundreds of acres of waterfront access, deepwater channel connectivity, multimodal logistics infrastructure, and room for long-term expansion—everything required to anchor a next-generation shipbuilding hub.

“Today marks history with the announcement of the most advanced shipyard in the entire world,” said Governor Abbott. “When this shipyard gets fully built out, there will be about 10,000 employees. Saronic is going to be providing about $750 million in annual paychecks to Texans. That’s game-changing for the population of Texas. As Governor, I’m proud that Saronic calls Texas home.”

Over the next decade, Port Alpha is expected to create up to 10,000 high-quality direct jobs spanning skilled trades such as welding and machining to advanced roles in robotics, software engineering, and naval architecture. The project aligns with national calls to rebuild the maritime workforce pipeline, creating new opportunities for skilled workers at the intersection of shipbuilding and advanced technology. Saronic will collaborate with the State of Texas, Cameron County, and local educational institutions – from regional technical colleges to leading State universities and institutions – to develop workforce training and apprenticeship programs designed to sustain long-term industrial growth and position South Texas as a center of excellence for advanced maritime manufacturing.

Port Alpha builds on Saronic’s expanding shipbuilding footprint. In early 2025, the company acquired a shipyard in Franklin, Louisiana, where it is investing $300 million to add 300,000 square feet of production capacity. That facility will continue producing Saronic’s 180-foot Marauder autonomous vessel, which was designed and launched in less than one year. Together, these facilities represent a multi-billion-dollar private capital commitment to restoring American shipbuilding capacity, advancing autonomous maritime systems, and strengthening the nation’s industrial resilience.

More than a shipyard, Port Alpha represents a new model for American shipbuilding—combining advanced manufacturing, software-defined production, and autonomy at unprecedented scale. To sustain that edge, Saronic is forging strategic partnerships with leading manufacturers, emerging shipbuilding technology providers, and premier suppliers, ensuring that the latest capabilities continuously strengthen and inform Port Alpha’s production architecture alongside Saronics’ in-house expertise. In doing so, Port Alpha embodies the transformation envisioned in national maritime strategy, one that leverages technology to strengthen deterrence, resilience, and operational flexibility. As construction advances, Saronic will continue working with federal, state, and local partners to establish the industrial foundation required for the next generation of maritime power in America.

Contact: press@saronic.com