ProstACT Global Phase 3 (Part 1) Selected as Late-Breaking Abstract at ASCO 2026

MELBOURNE, Australia and INDIANAPOLIS, April 22, 2026 (GLOBE NEWSWIRE) -- Telix Pharmaceuticals Limited (ASX: TLX, NASDAQ: TLX, “Telix”) today announces that safety and tolerability data from the ProstACT Global Phase 3 study (Part 1) will be presented as a late-breaking oral presentation at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting, taking place May 29 – June 2, 2026, in Chicago, IL.

ProstACT Global is an international, multi-center, Phase 3 trial evaluating Telix’s lead prostate-specific membrane antigen (PSMA) targeted lutetium radio antibody-drug conjugate (rADC) therapy, TLX591-Tx (lutetium-177 (¹⁷⁷Lu) rosopatamab tetraxetan), in combination with standard of care (SoC) versus SoC alone. The study is designed to reflect real-world global clinical practice with the aim to support broad geographic adoption in the evolving prostate cancer treatment landscape.

Part 1 of the trial is a safety and dosimetry lead-in, assessing the tolerability, biodistribution, and radiation dose profile of TLX591-Tx when administered in combination with SoC in patients with PSMA-positive metastatic castration-resistant prostate cancer (mCRPC).

The selection of this abstract as a late-breaking oral presentation at ASCO underscores the potential clinical significance of the ProstACT Global study and Telix’s continued leadership in advancing next-generation radiopharmaceutical therapies for prostate cancer.

Presentation details are as follows:

Title: Safety and dosimetry of ¹⁷⁷Lu-rosopatamab tetraxetan plus SoC in patients with metastatic castration-resistant prostate cancer: Preliminary results from Part 1 of Phase 3 ProstACT Global study.

Presenting Author: Pedro C. Barata, MD, MSc, University Hospitals Seidman Cancer Center, Cleveland, OH.

Abstract Number: LBA5009.

Date, Time and Location: June 1, 2026, 3:12 p.m. – 3:24 p.m. CDT, Arie Crown Theater

Session Type and Title: Clinical Science Symposium – Radiation Re-Imagined: Radioligand Innovation in Prostate Cancer

Late-breaking abstracts will be made publicly available at 7:00 a.m. CDT (8:00 a.m. EDT) on the day of presentation. Additional information can be found at www.asco.org

About ProstAct Global

ProstACT Global (ClinicalTrials.gov ID: NCT06520345) is an international, multi-center trial in two parts: Part 1, safety and dosimetry lead-in with 36 patients (complete); and Part 2, 2:1 randomized global expansion with an overall target enrollment of approximately 490 patients. Eligible patients must have confirmed progressive mCRPC assessed with a ⁶⁸Ga-PSMA-11 PET¹ imaging agent (such as Illuccix®, kit for the preparation of gallium-68 (⁶⁸Ga) gozetotide injection, or Gozellix®, kit for the preparation of gallium-68 (⁶⁸Ga) gozetotide injection) following prior treatment with one androgen receptor pathway inhibitor (ARPI).

The antibody approach demonstrates different targeting and pharmacology to that observed in other PSMA-targeted small molecule radioligand therapies (RLT). In contrast to these therapies², collective long-term follow-up of patients administered with TLX591-Tx has not observed significant acute or delayed kidney toxicity, as the agent is primarily cleared through the liver, a comparatively radioresistant organ, instead of the kidneys³. Due to its large molecular weight, TLX591-Tx also demonstrates minimal salivary and lacrimal gland uptake, reducing dry mouth and dry eyes, common adverse effects of existing PSMA-targeted RLTs⁴.

Additional information on the Phase 3 ProstACT Global study can be found at: https://telixpharma.com/prostact/

TLX591-Tx has not received a marketing authorization in any jurisdiction.

About Telix Pharmaceuticals Limited

Telix is a global biopharmaceutical company focused on the development and commercialization of radiopharmaceuticals with the goal of addressing significant unmet medical need in oncology and rare diseases. Telix is headquartered in Melbourne (Australia) with international operations in the United States, United Kingdom, Brazil, Canada, Europe (Belgium and Switzerland) and Japan. Telix is listed on the Australian Securities Exchange (ASX: TLX) and the Nasdaq Global Select Market (NASDAQ: TLX).

Visit www.telixpharma.com for further information about Telix, including details of the latest share price, ASX and U.S. Securities and Exchange Commission (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

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.

_______________________________
¹ Positron emission tomography.
² Tagawa et al. Curr Oncol Rep. 2021; Steinhelfer et al. J Nucl Med. 2024.
³ Tagawa et al. Cancer. 2019.
⁴ Pepin et al. Pract Radiat Oncol. 2025.