Telix Pharmaceuticals Ltd.

MELBOURNE, Australia, Oct. 30, 2024 /PRNewswire/ -- Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company) today announces a partnership with California-based Subtle Medical, Inc. (Subtle Medical) for artificial intelligence (AI)-powered positron emission tomography (PET) imaging with Telix's commercial PSMA-PET[1] product, Illuccix® (68Ga-PSMA-11). Subtle Medical's SubtlePET™ is a U.S. Food and Drug Administration (FDA) cleared AI-driven solution to enhance the efficiency and effectiveness of imaging procedures. The proprietary deep-learning algorithm allows for faster PET scanning – up to 75% time savings without compromising image quality. The technology represents a significant advancement in the field, offering numerous benefits to patients, physicians, and medical facilities. SubtlePET's ability to expedite the imaging process reduces patient wait times and increases comfort, with the patient required to remain motionless under the camera for a shorter period of time, contributing to an overall more positive healthcare experience. Additionally, a shorter scan time for Illuccix will allow healthcare providers to further optimise workflows and resource utilisation. Most importantly for facilities, SubtlePET seamlessly integrates into existing imaging center workflows, empowering healthcare providers to achieve faster PET imaging on any scanner, regardless of manufacturer or model. The technology can also extend scanner life through improved performance. Kevin Richardson, Chief Executive Officer, Telix Precision Medicine, said, "Through this partnership, we are excited to incorporate an innovative AI product into the Illuccix value proposition for our customers and the patients they serve. We believe that the combination of Illuccix and SubtlePET will further strengthen Telix's AI toolkit and also Illuccix's reputation as the best-in-class PSMA-PET imaging agent for accuracy, reliability, quality, and operational excellence in the U.S. As Telix looks to our future with a multi-product portfolio, we look forward to growing our partnership with Subtle Medical to advance patient care and more efficient PET workflows across the disease spectrum." Josh Gurewitz, Chief Commercial Officer, Subtle Medical, commented, "We are pleased to commercially partner with Telix, a global leader in theranostics. This agreement represents a significant milestone for both companies, as we join forces to empower medical professionals and improve outcomes for patients with Subtle Medical's platform and innovative AI product for PET imaging, starting with prostate cancer." The partnership with Telix, which covers North America and the European Union (EU, excluding France and French speaking Belgium), launches in the United States (U.S.) with Illuccix, with the aim to expand to other Telix PET-tracers, subject to regulatory approval. To sign up for more information on Illuccix and SubtlePET visit About Subtle Medical, Inc. Subtle Medical is a leading innovator in medical imaging software, utilising advanced AI technologies to enhance the efficiency and effectiveness of imaging procedures. The company's solutions, SubtlePET™ and SubtleMR™, leverage proprietary algorithms to improve scan times and image quality, aiming to improve patient outcomes and the diagnostic process. SubtlePET has received 510(k) clearance from the FDA and is Conformité Européenne (CE) marked in the EU for use with multiple PET tracers. Subtle Medical is committed to transforming medical imaging through its cutting-edge solutions, making it faster, safer, and more accessible to patients worldwide. For more information, please visit or email [email protected] About Telix Pharmaceuticals Limited Telix is a biopharmaceutical company focused on the development and commercialisation of diagnostic and therapeutic 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. FDA[2], by the Australian Therapeutic Goods Administration (TGA)[3], and by Health Canada[4]. Visit 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 Telix Investor Relations Ms. Kyahn Williamson Telix Pharmaceuticals Limited SVP Investor Relations and Corporate Communications Email: [email protected] 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. Logo - WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

The future of Telix Pharmaceuticals’ new spinout Rhine Pharma hinges on the outcome of one early-stage trial, Telix CEO Christian Behrenbruch told Endpoints News in an interview . If Rhine’s only radiotherapy asset, dubbed RHN001, passes a Phase 1/2 trial, Telix will look for external investors to back the spinout into its next stages, Behrenbruch said. Otherwise, the asset will likely be handed back to Heidelberg University Hospital, where it was developed, he added. Telix announced the spinoff on Tuesday. Rhine is currently a wholly-owned subsidiary of Telix, but it will become independent once “key milestones are achieved,” though the release did not elaborate further. Rhine is yet to finalize employee numbers as it is still being formed, a spokesperson said. As Australian radiopharma Telix is growing, RHN001 no longer fits with its “core pipeline,” so the company, alongside Heidelberg University Hospital, decided to spin off the asset’s development with the new entity, Behrenbruch said. Telix will fund the early-phase trial, and results are expected in a year. RHN001 is being investigated for prostate cancer. When it has the radioisotope technetium-99m, it can be used for imaging. And if it has rhenium-188, it could have potential as a radiotherapy. The radiopharma space is heating up, and Telix has been busy bolstering its portfolio through numerous acquisitions, notably buying up RLS Radiopharmacies to expand its presence in the US. Manufacturing has been a talking point in the radiopharma space, with companies like Novartis needing to fix supply issues for its assets. RHN001’s two isotopes can be manufactured inside generators at any location, which require less manufacturing infrastructure compared to bioreactors that make more traditional isotopes like lutetium-177 and actinium-225, Behrenbruch said. Behrenbruch compared the generators to fridges where the isotopes are like ice cubes. This is a more decentralized manufacturing approach, which avoids the transportation of isotopes that have short shelf lives, making them difficult to ship , Behrenbruch said. Telix and Heidelberg University Hospital began their partnership back in 2021 to research radiotherapies for cancer affecting urinary tracts and reproductive parts.

Alpha-9 Oncology has raised $175m in a Series C funding round to advance its pipeline of radiopharmaceuticals. Credit: eamesBot via Shutterstock. Alpha-9 Oncology is the latest radiopharma to raise funds, drawing in $175m in Series C financing, to advance its radiopharmaceutical candidates through clinical trials and expand its research and development (R&D) capabilities. Vancouver, Canada-based Alpha-9 shared that it will advance its pipeline of preclinical candidates to the “clinic-ready” stage. While the company has not disclosed which of its assets in particular will be advanced, the company has several preclinical programs targeting MC1R, PSMA, GRPR, CXCR4, and B1R, as per GlobalData’s Pharma Intelligence Center. In May 2024, Alpha-9 announced the dosing of the first patient in its Phase I study for the MC1R programme, dubbed A9-3202. This peptide-based radiopharmaceutical targets the melanocortin 1 receptor for imaging locally advanced or metastatic melanoma. The trial is evaluating A9-3202’s tumour uptake and distribution in normal tissue among participants with melanoma. This latest financing comes after a flood of investment into the radiopharma arena over the last few years. Earlier this month, Aktis Oncology raised $175m to support the development of its new radiopharmaceuticals, including a first-in-class Nectin-4-targeted miniprotein radioconjugate. Big pharma has jumped on the radiopharma train too, with Bristol Myers Squibb (BMS), Novartis , and Eli Lilly signing acquisition deals worth $4.2bn , $1.75bn , and $1.4bn, respectively. Alpha-9’s Series C – co-led by Lightspeed Venture Partners and Ascenta Capital – builds on a $75m Series B in December 2022, and a $8.9m Series A in 2021, three years after the company spun-out from the University of British Columbia. Other participating investors in this round included a16z Bio + Health, RA Capital Management, Janus Henderson Investors and Samsara BioCapital. See Also: UPFs fuelling ‘alarming rise of chronic diseases’ in india FDA grants ODD to Modalis’ MDL-101 to treat LAMA2-CMD Alpha-9 said its funding will also support ongoing investments in its discovery capabilities, as well as the expansion of manufacturing and isotope supply partnerships. The company recently completed the construction of a manufacturing facility in Vancouver, Canada. Last month, Telix Pharmaceuticals paid $230m upfront to acquire US-based radioisotope manufacturer RLS Radiopharmacies to expand its manufacturing footprint in the US. Venture financing for innovative radiopharmaceutical drugs has witnessed an approximately 550% increase from $63m in 2017 to $408m in 2023 YTD (year-to-date) total deal value in the US, according to GlobalData’s Pharma Intelligence Center Deals Database. GlobalData is the parent company of Pharmaceutical Technology. In the announcement accompanying the financing, Alpha-9’s CEO David Hirsch said: “Over the last few years, Alpha-9 has built a leading radiopharmaceutical company with a deep pipeline and robust infrastructure.”