Telix Adds Lead-212 Isotope Production Capability

Rhea-AI Summary

Telix Pharmaceuticals (ASX/Nasdaq: TLX) has announced a breakthrough in lead-212 (212Pb) isotope production technology. The company has developed and validated a new generator technology through its IsoTherapeutics team that produces 212Pb using a sealed Thorium-228 source.

The innovative generator technology offers significant improvements over existing solutions, including:

• Increased radioactivity, yield, and shelf life
• Fully automated operation
• Small, single hot cell footprint
• Capacity to produce up to 60 clinical doses per elution
• Potential for further scaling

The technology is designed for deployment across Telix's manufacturing and distribution networks, including the recently acquired RLS Radiopharmacies network. Lead-212, with its 10.6-hour half-life, is considered promising for Targeted Alpha Therapy (TAT), and this development addresses previous commercial scalability limitations.

Positive

• Breakthrough in lead-212 production technology with increased yield and efficiency
• Capability to produce up to 60 clinical doses per elution
• Technology enables commercial-scale production previously not possible
• Integration with existing radiopharmacy infrastructure
• Expands potential for new targeted alpha therapy development

Negative

• Short half-life of lead-212 (10.6 hours) may present logistical challenges

Insights

Financial Analyst

Telix's breakthrough in lead-212 isotope production represents a significant technological advancement with meaningful commercial implications. By developing generator technology that increases radioactivity, yield, and shelf life of lead-212 while enabling production of up to 60 clinical doses per generator, Telix has potentially solved a critical supply chain bottleneck in radiopharmaceutical development.

This innovation addresses the commercialization barriers that have lead-212's therapeutic potential despite its promising properties for Targeted Alpha Therapy (TAT). The technology's small footprint and integration capabilities with Telix's existing radiopharmacy network create operational efficiencies that could translate to cost advantages and wider market access.

From a strategic perspective, this vertical integration strengthens Telix's competitive positioning in the radiopharmaceutical space. The company can now potentially control more of its value chain while creating new pipeline opportunities by pairing this alpha-emitting isotope with their targeting agents and engineered antibodies from their recently acquired discovery platform.

While no immediate revenue impact is mentioned, this development enhances Telix's long-term growth prospects by expanding their technological capabilities and potentially opening new therapeutic applications in their pipeline.

Medical Technology Expert

Telix's lead-212 generator technology represents a significant technical breakthrough in radiopharmaceutical production. The 10.6-hour half-life of lead-212 has been a fundamental limitation for its therapeutic applications, despite its desirable alpha-emitting properties. What Telix has accomplished is transforming a theoretically useful isotope into one with practical commercial potential.

The sealed thorium-228 source design with fully automated elution is particularly noteworthy, as it addresses both safety and scalability challenges simultaneously. The system's ability to fit within existing radiopharmacy infrastructure removes a major adoption barrier and potentially accelerates clinical implementation.

The synergy between lead-212's pharmacological profile and Telix's antibody development platform creates a compelling technological package. Alpha-emitting radiopharmaceuticals deliver concentrated radiation directly to targeted cells while minimizing collateral damage to surrounding healthy tissue - a persistent challenge in traditional radiotherapy.

This development positions Telix advantageously in the rapidly evolving radiopharmaceutical landscape, where production capacity and isotope access often constrain product development. By solving this production challenge internally rather than licensing external technology, Telix maintains greater control over their development pipeline and potentially creates licensable intellectual property of their own.

MELBOURNE, Australia and INDIANAPOLIS, March 13, 2025 (GLOBE NEWSWIRE) -- Telix Pharmaceuticals Limited (ASX: TLX, Nasdaq: TLX, Telix, the Company) today announces that it has developed and validated a breakthrough generator technology for the production of lead-212 (²¹²Pb) and successfully completed first production.

The new generator technology, developed internally by Telix’s IsoTherapeutics team, produces ²¹²Pb via a sealed Thorium-228 (²²⁸Th) source, and significantly increases the amount of radioactivity, yield and shelf life compared to currently available ²¹²Pb generators. The fully automated, high-output generators have a small, single hot cell footprint and produce sufficient ²¹²Pb elution for up to 60 clinical doses, with the potential to further scale. The production footprint has been designed to be deployed throughout Telix’s (and select partner) manufacturing and distribution networks, including the recently acquired RLS Radiopharmacies network. This development builds on Telix’s extensive experience with developing generator-based radiopharmaceutical products.

The novel technology opens new opportunities for the development of alpha-emitting radiopharmaceuticals for use in Telix’s next-generation therapeutics pipeline. Lead-212 is a promising isotope for Targeted Alpha Therapy (TAT) but its relatively short half-life (10.6 hours, compared with 9.9 days for actinium-225, ²²⁵Ac) and lack of production scale has limited commercial potential. The alpha-emitting profile of ²¹²Pb also has practical synergies with engineered antibodies being developed using Telix’s newly acquired discovery platform¹, with pharmacology and clearance organ characteristics that are well suited to its short half-life.

Chad Watkins, General Manager, Isotope Strategy, Telix, said, “A lead-212 generator that produces minimal waste and fits within the current radiopharmacy footprint is a step change in the production of this alpha emitting therapeutic radioisotope. It creates the potential for commercial scale lead-212 isotope production that wasn't possible before and opens up new pathways for matching this promising alpha isotope with a range of targeting agents.”

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, 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. ARTMS, IsoTherapeutics, Lightpoint, Optimal Tracers and RLS are Telix Group companies. 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 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.

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¹ Telix ASX disclosure 31 January 2025.

Telix Investor Relations

Ms. Kyahn Williamson
Telix Pharmaceuticals Limited
SVP Investor Relations and Corporate Communications
Email: kyahn.williamson@telixpharma.com

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 commercialisation 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; 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. The 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.

FAQ

What are the key advantages of Telix's new lead-212 generator technology?

TLX's new generator technology offers increased radioactivity, yield, and shelf life, produces up to 60 clinical doses, has a small footprint, and is fully automated.

How does the half-life of lead-212 compare to actinium-225 in TLX's production system?

Lead-212 has a 10.6-hour half-life, significantly shorter than actinium-225's 9.9-day half-life.

Where will TLX deploy its new lead-212 production technology?

The technology will be deployed throughout Telix's manufacturing and distribution networks, including the recently acquired RLS Radiopharmacies network.

What is the significance of lead-212 in Targeted Alpha Therapy (TAT)?

Lead-212 is a promising isotope for TAT, with its alpha-emitting profile well-suited for use with engineered antibodies in therapeutic applications.