Telix Announces Collaborations to Explore PSMA-PET Imaging in Emerging Prostate Cancer Treatment Approaches

Telix to partner with companies developing advanced minimally invasive and image-guided ablative technologies for prostate cancer.
Initial focus on patient selection, treatment planning and post-treatment monitoring; evidence generation to inform best practice.
Aim to accelerate adoption of novel therapeutic workflows to enhance clinical decision making and patient outcomes.

MELBOURNE, Australia and INDIANAPOLIS, May 15, 2026 (GLOBE NEWSWIRE) -- Telix Pharmaceuticals Limited (ASX: TLX, NASDAQ: TLX, “Telix”) today announces that it has entered into letters of intent to pursue collaborations with EDAP TMS S.A. (NASDAQ: EDAP, “EDAP”) and Profound Medical Corp. (NASDAQ: PROF, TSX: PRN, “Profound”), leading companies developing advanced minimally invasive and image-guided treatment ablative technologies for prostate cancer, including focal, subtotal, and whole-gland treatment approaches. These initiatives reflect Telix’s commitment to advancing the integration of molecular imaging into the evolving prostate cancer treatment landscape to help inform clinical decision-making.

The collaborations will explore the investigational use of Telix’s PSMA-PET¹ imaging agents Gozellix® (kit for the preparation of gallium Ga 68 gozetotide) and Illuccix® (kit for the preparation of gallium Ga 68 gozetotide) with robotic high-intensity focused ultrasound (HIFU), and other image-guided therapies designed to treat localized prostate cancer, such as transurethral ultrasound ablation (TULSA).

Telix’s intention is to work with select partners to explore how PSMA-PET imaging may support emerging therapy workflows, which aim to preserve healthy tissue and minimize the risk of side effects such as incontinence and impotence. Collaborative activities will focus on non-promotional scientific, educational, and research engagement².

“We are uniquely designed to enable the integration of PSMA-PET imaging with Focal One’s real-time ultrasound and fully robotic energy delivery to optimize treatment efficacy while minimizing side effects,” said Ryan Rhodes, EDAP Chief Executive Officer. “As the market leader in robotic focal therapy, with a growing global installed base, this collaboration will accelerate the development and standardization of treatment strategies to further personalize focal therapy treatments using Telix’s PSMA-PET imaging agents and Focal One Robotic HIFU.”

“Emerging clinical evidence suggests PSMA imaging may support prostate whole-gland, partial-gland, and focal ablation workflows, from treatment planning through post-treatment monitoring,” said Arun Menawat, Profound’s Chief Executive Officer and Chairman. “In collaboration with Telix, we look forward to exploring optimized workflows and generating clinical evidence that may help establish best practices and accelerate adoption of PSMA-PET imaging and the MRI-guided TULSA Procedure.”

“Precision medicine requires precision treatment strategies,” said Kevin Richardson, CEO, Telix Precision Medicine. “As disruptive technologies continue to transform prostate cancer care, we believe PSMA-PET imaging has the potential to play an important role in helping inform clinical decision-making across a range of minimally invasive and image-guided treatment approaches. We are excited to explore collaborations with market leaders in EDAP and Profound that may further advance personalized care for patients.”

About EDAP TMS SA

A recognized leader in robotic energy-based therapies, EDAP TMS develops, manufactures, promotes, and distributes worldwide minimally invasive medical devices for various conditions using ultrasound technology. By combining the latest technologies in imaging, robotics, and precise non-invasive energy delivery, EDAP introduced the Focal One® in Europe and the United States as a leading prostate focal therapy platform controlled by urologists, with the potential to expand to multiple indications beyond prostate cancer. For more information on the Company, please visit focalone.com.

About Profound Medical Corp.

Profound is a commercial-stage medical device company and an innovator in interventional MRI procedures. The company’s flagship platform, TULSA-PRO®, enables MRI-guided, incision-free prostate ablation. Physicians use the TULSA Procedure™ to see, ablate, and confirm therapy in real time, supporting personalized treatment strategies across the continuum of prostate care—from whole-gland to subtotal, hemi, multifocal, and focal treatment. This approach enables individualized care using prostate tissue ablation, while minimizing the potential of the side effects that are typically associated with surgery or radiation, such as urinary incontinence and/or erectile dysfunction.

Profound Medical’s technologies are approved across major global markets. TULSA-PRO is cleared by the FDA in the United States for transurethral ultrasound ablation (TULSA) of prostate tissue. In addition, TULSA-PRO is cleared for use in various jurisdictions including Europe, Canada, Saudi Arabia, India, Australia/New Zealand, and the UAE.

IMPORTANT SAFETY INFORMATION (GOZELLIX)

WARNINGS AND PRECAUTIONS
Risk for Misinterpretation
Image interpretation errors can occur with GOZELLIX 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 Therapy
The performance of GOZELLIX for imaging of biochemically recurrent prostate cancer seems to be affected by serum PSA levels and by site of disease. The performance of GOZELLIX for imaging of metastatic pelvic lymph nodes prior to initial definitive therapy seems to be affected by Gleason score.

Radiation Risks
Gallium 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.

Hypersensitivity Reactions to Sulfites
Ascorbic Acid Stabilizer contains sodium metabisulfite, a sulfite that may cause allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown and probably low. Sulfite sensitivity is seen more frequently in asthmatic than in non-asthmatic people.

ADVERSE REACTIONS
The safety of gallium Ga-68 gozetotide was evaluated in 960 patients in the PSMA-PreRP and PSMABCR 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%.

DRUG INTERACTIONS
Androgen deprivation therapy and other therapies targeting the androgen pathway Androgen 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.

IMPORTANT SAFETY INFORMATION (ILLUCCIX)
WARNINGS AND PRECAUTIONS

Risk for Misinterpretation
Image 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 Therapy
The 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 Risks
Gallium 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 REACTIONS
The 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.

Injection site pain has been identified during postapproval use of ILLUCCIX.

DRUG INTERACTIONS
Androgen deprivation therapy and other therapies targeting the androgen pathway
Androgen 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.

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.

Telix Investor Relations (Global) Ms. Kyahn Williamson SVP Investor Relations and Corporate Communications kyahn.williamson@telixpharma.com	Telix Investor Relations (Australia) Ms. Charlene Jaw Associate Director Investor Relations charlene.jaw@telixpharma.com	Telix Investor Relations (U.S.)  Ms. Annie Kasparian  Director Investor Relations and Corporate Communications  annie.kasparian@telixpharma.com

Telix Media Contact (U.S.) Eliza Schleifstein 917.763.8106 (Mobile) Eliza@schleifsteinpr.com	EDAP Investor Relations Louisa Smith Gilmartin Group investor.relations@focalone.com	Profound Investor Relations Stephen Kilmer 647.872.4849 (Mobile) skilmer@profoundmedical.com

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^{______________________________________}¹ Imaging of prostate-specific membrane antigen.
² PSMA-PET imaging is not currently approved for specific treatment-planning indications associated with these emerging therapies.

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