Telix Spins Off Rhine Pharma™ to Expand Global Access to Radiopharmaceuticals

MELBOURNE, Australia, Oct. 22, 2024 /PRNewswire/ -- Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company) today announces the spin-off of Rhine Pharma^[1], which has the mission of expanding global access to innovative radiopharmaceuticals for cancer imaging and treatment using two generator-produced isotopes, technetium-99m (^99mTc) and rhenium-188 (¹⁸⁸Re).

Rhine Pharma was formed following a collaboration between Telix and Heidelberg University Hospital (UKHD), which aimed to develop a PSMA^[2]-targeting small molecule that could be labelled with either ^99mTc for SPECT^[3] imaging, or ¹⁸⁸Re for radioligand therapy. The collaboration successfully created a potential next-generation theranostic compound, RHN001^[4], which Rhine Pharma is now advancing into a novel Phase I/IIa theranostic clinical study (the 'RHINO Trial'), exploring the safety profile and efficacy of both ^99mTc-RHN001 and ¹⁸⁸Re-RHN001 in patients with advanced prostate cancer.

Because ^99mTc and ¹⁸⁸Re can each be produced using on-site generators, they enable a highly-differentiated solution for regions with limited radiopharmaceutical manufacturing infrastructure or dispersed populations. ^99mTc enables imaging of patients with widely available SPECT scanners, while ¹⁸⁸Re has demonstrated potential as a therapeutic isotope, thanks to its high-energy beta emission that maximises damage to tumour cells. Its short half-life (16.9 hours) also has the potential to simplify patient workflows in busy treatment centres with high patient demand or limited nuclear waste management capabilities.

Radiopharmaceuticals based on more common therapeutic radioisotopes (on market or in development) such as lutetium-177 (¹⁷⁷Lu) and actinium-225 (²²⁵Ac), are typically centrally manufactured in facilities that require significant investment and infrastructure to operate, such as reactors or cyclotrons. By contrast, a generator is a convenient system for on-site production of some commonly-used radionuclides.

Richard Valeix, Chief Executive Officer, Therapeutics, Telix, said, "Rhine Pharma is an example of identifying an access-to-medicine challenge and then working to fix it. While radiopharmaceuticals can be a powerful way to image and treat cancer, manufacturing doses and getting them to patients can be complex and costly, particularly in emerging markets or geographically dispersed populations. Using generators for production could reduce costs and simplify the supply chain. This means the combination of ¹⁸⁸Re and ^99mTc has potential for addressing unmet needs in cancer treatment for more people, in more countries."

Christian Behrenbruch, Managing Director and Group Chief Executive Officer, Telix, said, "This is an exciting story of collaborative innovation aligned with our values, particularly our commitment to increasing access to medicine. It also demonstrates Telix's ability to drive in-house innovation that can move seamlessly from the laboratory to the clinic and evolve commercially. Spinning off Rhine Pharma makes room in our pipeline for future opportunities and gives Rhine Pharma the focus it needs to succeed."

Rhine Pharma is strongly supported by its renowned Founding Scientific Advisors - Professor Frederik Giesel^[5], Professor Ken Herrmann^[6], Professor Clemens Kratochwil^[7] and Dr Jens Cardinale^[8] - and is working closely with the Nuclear Medicine Research Infrastructure (NuMeRI), a groundbreaking facility at the University of Pretoria, South Africa. Opened in May 2024, the facility is committed to advancing nuclear medicine research in the region. The RHINO Trial has received both ethics and regulatory approval in South Africa and is being run by NuMeRI's CEO and President, Professor Mike Sathekge, and his team.

Professor Sathekge said, "NuMeRI is working to bring the benefits of precision medicine and radiopharmaceutical therapy to more people, regardless of their location or income. It's only through innovation and collaboration that we can marshal the resources needed to achieve this goal, and partnering with Rhine Pharma on this clinical trial is an exciting opportunity to advance research in this area. We look forward to seeing how RHN001 performs in the clinic."

About Rhine Pharma

Rhine Pharma™ is a wholly-owned subsidiary of Telix and once key milestones are achieved, Telix plans to structure it as an independent company. Its mission is to expand global access to innovative cancer imaging and therapy by leveraging the unique benefits of technetium-99m (^99mTc) and rhenium-188 (¹⁸⁸Re).  Visit www.rhine-pharma.com^[1] for further information.

About Telix Pharmaceuticals Limited

Telix is a biopharmaceutical company focused on the development and commercialisation of therapeutic and diagnostic 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).

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 U.S. Food and Drug Administration (FDA)^[9], by the Australian Therapeutic Goods Administration (TGA) ^[10], and by Health Canada^[11]. No other Telix product has received a marketing authorisation in any jurisdiction.

Visit www.telixpharma.com^[2] 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^[3].

Telix Investor Relations

Ms. Kyahn WilliamsonTelix Pharmaceuticals LimitedSVP Investor Relations and Corporate CommunicationsEmail: kyahn.williamson@telixpharma.com^[4]

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) 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 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.

©2024 Telix Pharmaceuticals Limited. The Telix Pharmaceuticals® and Illuccix® names and logos are trademarks of Telix Pharmaceuticals Limited and its affiliates – all rights reserved.

References

1. ^{^} www.rhine-pharma.com (rhine-pharma.com)
2. ^{^} www.telixpharma.com (www.telixpharma.com)
3. ^{^} LinkedIn (www.linkedin.com)
4. ^{^} kyahn.williamson@telixpharma.com (www.prnasia.com)