6-K
Telix Pharmaceuticals Ltd (TLX)
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 6-K
REPORT OF FOREIGN PRIVATE ISSUER
PURSUANT TO RULE 13a-16 OR 15d-16 OF
THE SECURITIES EXCHANGE ACT OF 1934
For the month of November, 2024
Commission File Number: 001-42128
Telix Pharmaceuticals Limited
(Translation of registrant’s name into English)
55 Flemington Road
North Melbourne, Victoria 3051, Australia
(Address of principal executive offices)
Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F.
Form 20-F ☒ Form 40-F ☐
INFORMATION CONTAINED IN THIS FORM 6-K REPORT
On November 19, 2024, Telix Pharmaceuticals Limited (the “Company”) filed with the Australian Securities Exchange (“ASX”) an announcement (the “Announcement”) captioned
“Telix to Add FAP-Targeting Candidates to Theranostic Pipeline”, a copy of which Announcement is attached to this Form 6-K as Exhibit 99.1.
Attached as Exhibit 99.2 is a presentation the Company filed with the ASX on November 19, 2024 in connection with the Announcement.
| 99.1 | Press release dated November 19, 2024 |
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| 99.2 | Presentation dated November 19, 2024 |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
| Telix Pharmaceuticals Limited | ||
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| Date: November 19, 2024 | By: | /s/ Genevieve Ryan |
| Name: Genevieve Ryan | ||
| Title: Company Secretary |
Exhibit 99.1
| Telix Pharmaceuticals Limited<br><br> <br>ACN 616 620 369<br><br> <br>55 Flemington Road<br><br> <br>North Melbourne<br><br> <br>Victoria, 3051<br><br> <br>Australia<br><br> <br><br><br> <br>ASX ANNOUNCEMENT |
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Telix to Add FAP-Targeting Candidates to Theranostic Pipeline
Melbourne (Australia) – 19 November 2024. Telix Pharmaceuticals Limited (ASX: TLX; Nasdaq: TLX, Telix, the Company) today announces it will expand its theranostic pipeline with new assets targeting Fibroblast Activation Protein (FAP), one of the most promising pan-cancer targets in nuclear medicine. Telix’s development program will initially focus on the treatment of bladder cancer, rounding out its urology franchise, which includes late-stage therapeutic programs for kidney and prostate cancers.
FAP is a pan-cancer marker expressed in the tumour microenvironment of epithelial cancers and on the surface of some specific cancer types, including sarcomas and mesotheliomas.
Telix has entered into asset purchase and exclusive worldwide in-licence agreements for a suite of clinically validated FAP-targeting therapeutic and precision medicine (diagnostic) radiopharmaceutical candidates developed by Professor Frank Roesch and his collaborators at the Institute of Nuclear Chemistry at the Johannes Gutenberg-Universität Mainz, Germany. The next-generation therapeutic assets are differentiated by a novel structure that drives extended tumour retention while minimising off-target uptake, potentially overcoming the limitations seen with first-generation compounds. The diagnostic and therapeutic compounds have been clinically validated in over 500 patients across a variety of solid tumours and are the subject of multiple peer-review publications^1^.
Richard Valeix, Chief Executive Officer, Telix Therapeutics, said, “We are delighted to partner with Professor Roesch and his team on this exciting frontier of radiopharmaceuticals. Telix will gain access to assets that are already significantly de-risked, with clinically demonstrated safety profile and efficacy. We will develop these assets in bladder cancer as a primary indication, in line with our focus on urological cancers, and explore the potential of FAP as a pan-cancer target, adding significant value to our pipeline.”
Frank Roesch, professor emeritus, said, “Over the past two years, our FAP inhibitor-based theranostic candidates have seen extensive preclinical and clinical evaluation. Collaboration has been very important, and I am grateful to many colleagues around the world who have contributed to advancing the molecules to this point. We are excited to be working with Telix as a leader in radiopharmaceutical innovation, development and commercialisation, to further develop and bring these drug candidates to regulatory approval. The ultimate goal is to improve the diagnostic precision and therapeutic outcomes of cancer patients in need.”
Deal terms and conditions
Under an exclusive worldwide licence agreement with a German company controlled by Professor Roesch, SCV GmbH, and a concurrently-signed asset purchase agreement with German company Medianezia GmbH, which collectively hold the intellectual property rights to the FAP assets, Telix will pay €7 million in cash as of closing (inclusive of €700,000 paid at or prior to the signing of the agreements) and a further €3 million in 12 months’ time subject to any potential indemnity setoff.
^1^ Ballal et al. Pharmaceuticals. 2021; Ballal et al. JNM. 2022; Ballal et al. JNM. 2023; Bal et al. JNM. 2024.
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Telix will pay up to a further €132 million contingent upon achievement of certain clinical development and regulatory milestones related to both the diagnostic and therapeutic products under both agreements. An additional €20 million will be payable under the licence agreement on achievement of certain commercial milestones related to the diagnostic product; as well as royalties on net sales in the low to mid-single digits on the diagnostic product and an earlier formulation of the therapeutic product, if used.
Closing of the licence agreement and asset purchase agreement is expected to occur simultaneously and is subject to customary closing conditions including, with respect to the acquisition of assets, assignment of patents rights and foreign direct investment (FDI) approval of Germany’s Ministry for Economic Affairs and Climate Action. Telix cannot guarantee these transactions will close in any specific timeframe or upon the terms summarised herein, if at all.
About Telix Pharmaceuticals Limited
Telix is a biopharmaceutical company focused on the development and commercialisation of therapeutic and diagnostic radiopharmaceuticals and associated medical technologies. 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) and the Nasdaq Global Select Market (Nasdaq: TLX).
Telix’s lead imaging product, gallium-68 (^68^Ga) gozetotide injection (also known as ^68^Ga PSMA-11 and marketed under the brand name Illuccix®), has been approved by the U.S. Food and Drug Administration (FDA)^2^, by the Australian Therapeutic Goods Administration (TGA)^3^, and by Health Canada^4^. No other Telix product has received a marketing authorisation in any jurisdiction.
Visit www.telixpharma.com 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: kyahn.williamson@telixpharma.com
This announcement has been authorised for release by the Telix Pharmaceuticals Limited Disclosure Committee on behalf of the Board.
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 registration statement 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.
^2^ Telix ASX disclosure 20 December 2021.
^3^ Telix ASX disclosure 2 November 2021.
^4^ Telix ASX disclosure 14 October 2022.
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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.
©2024 Telix Pharmaceuticals Limited. The Telix Pharmaceuticals® and Illuccix® names and logos are trademarks of Telix Pharmaceuticals Limited and its affiliates – all rights reserved.
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Exhibit 99.2
Adding FAP-Targeting Candidates to Theranostic Pipeline Investor Presentation November 2024 ASX: TLX | NASDAQ: TLX 3D rendering of cancer associated fibroblast layer of tumour microenvironment.
Disclaimer This presentation should be read 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 registration statement on Form 20-F filed with the SEC, or on our website. The information contained in this presentation is not intended to be an offer for subscription, invitation or recommendation with respect to shares of Telix Pharmaceuticals Limited (Telix) in any jurisdiction, including the United States. The information and opinions contained in this presentation 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 presentation, 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 this presentation. This presentation 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 Telix’s 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. This presentation also contains estimates and other statistical data made by independent parties and by Telix relating to market size and other data about its industry. This data involves a number of assumptions and limitations, and you are cautioned not to give undue weight to such data and estimates. In addition, projections, assumptions and estimates of Telix’s future performance and the future performance of the markets in which it operates are necessarily subject to a high degree of uncertainty and risk. 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), by the Australian Therapeutic Goods Administration (TGA), and by Health Canada. No other Telix product has received a marketing authorisation in any jurisdiction. This presentation has been authorised for release by the Telix Pharmaceuticals Limited Disclosure Committee on behalf of the Board. ©2024 Telix Pharmaceuticals Limited. The Telix Pharmaceuticals® and Illuccix® names and logos are trademarks of Telix Pharmaceuticals Limited and its affiliates – all rights reserved. 2
Transaction to add clinically-validated FAP assets to pipeline A promising pan-cancer target with initial focus on bladder cancer Rettig et al. Proc Natl Acad Sci USA. 1988. Conversion to AUD$ is at an average exchange rate of AU$1 = EUR € 0.61 Strategic acquisition bolsters Telix’s focus in urology Fibroblast Activation Protein (FAP) is one of the most exciting targets in nuclear medicine – expressed in over 90% of epithelial cancers1 Next-generation assets have potential for imaging, and both alpha and beta therapy applications Demonstrated safety and efficacy profile in extensive pre-clinical and clinical validation Developed by renowned radiochemist Professor Frank Roesch and team Next generation of FAP-targeting theranostics Bolsters pipeline with a pan-cancer program complementing Telix’s CAIX portfolio Initial development program to focus on bladder cancer, which rounds out urology franchise Deal summary €7M cash (upfront) (AU$11M) €3M cash (12 months’ time) (AU$5M) Up to €132M subject to clinical milestones (AU$215M) Up to €20M subject to commercial milestones (AU$33M)2 3
FAP: The Achilles’ heel of cancer? Targeting key players in the tumour microenvironment (TME) 4 CAFs are marked by significantly increased levels of Fibroblast Activation Protein (FAP) FAP is expressed in CAFs as well as on some tumour cells, creating a potential double-hit to the tumour FAP is a druggable target and therefore a potential Achilles’ heel of cancer Cancer cells can ‘manipulate’ normal fibroblasts to promote tumour growth Permanently activated fibroblasts are known as Cancer Associated Fibroblasts (CAF) Fibroblasts are cells which help to form connective tissue and promote the body’s normal healing process In cancer this forms part of a protective wall around the tumour called stroma - protecting it from immune response Stroma makes up >70% of solid tumour mass1 Micke et al., EBioMedicine. 2021. TME CAF FAP Dx/Tx
The theranostic potential of FAP Using radiation to image, damage or destroy cancer cells 5 Zboralski et al., EJNMMI. 2022. Novruzov et al. Molecular Imaging and Biology. 2022. Koshkin et al. JNM. 2024. 68Ga-FAPI PET in 65-y-old patient with bladder cancer2 FAP Imaging in bladder cancer exemplifies potential for therapeutic approach FAP is highly expressed in the TME of epithelial cancers, and on the surface of some specific cancer types, including sarcomas and mesotheliomas1 By delivering radiation to CAFs, targeted radionuclide therapy has the potential to damage or destroy the cancer stroma and cancer cells Powerful therapy potential Overexpressed in cancer Weakening of the cancer stroma may also improve the effectiveness of other therapies Combined treatment options FAP targeting for imaging patients2,3 - superior to FDG - highlights its potential to address a significant unmet need through a theranostic approach Demonstrated evidence in bladder cancer Patient representative scans - individual results may vary.
Cracking therapeutics: A new way to target FAP New assets have potential to overcome key challenges 6 Yadav et al. EJNMMI. 2024. Ballal et al. Pharmaceuticals (Basel). 2021. Martin et al. Cancers. 2023. AIIMS, New Delhi, India. Clinically validated for safety profile and efficacy in several cancer types, under an extensive compassionate use program1-4 First-generation FAP-targeting candidates limited by short tumour residence Telix’s next generation candidates have a novel design enabling: Extended tumour retention Minimal off-target uptake Significant radiotherapeutic dose to tumour Improved clearance Labelling with either 177Lu (beta) or 225Ac (alpha) Potential for beta and alpha therapy
Clinical evidence for acquired next-gen compounds Proof-of-concept in-human study and extensive compassionate use 7 Ballal et al. Pharmaceuticals. 2021; Ballal et al. JNM. 2022; Ballal et al. JNM. 2023; Bal et al. JNM. 2024. AIIMS, New Delhi, India. Data on file. Laeppchen et al. Molecules. 2024. Successful proof of concept across diagnostic, therapeutic, for multiple indications FAP-targeting diagnostic has been used in >400 patients, establishing safety profile2 Safety profile established Extensive clinical data Used as therapy in >120 patients across sarcoma, breast, thyroid and medullary thyroid cancers to date1 Pan-cancer uses Builds on extensive preclinical data, published in several peer-reviewed papers3 Peer-reviewed data 68Ga-DOTA.SA.FAPi PET/CT 177Lu-DOTA.(SA.FAPi)2 post-therapy serial whole-body scans 24h 168h Radiotracer retention in metastatic sites at 168 hours Intense accumulation of radiotracer in tumour mass (arrows) and multiple skeletal sites (right femur-arrow head). Published data demonstrates therapeutic potential1 Patient representative scans - individual results may vary.
Compelling responses seen in late-stage cancer patients Significant tumour mass reduction following treatment with therapeutic candidate 8 AIIMS, New Delhi, India. Data on file. Treatment with 177Lu-based, FAP-targeted therapeutic candidate in-licensed by Telix Before After FAP-targeted PET Patient with breast cancer1 Before After FDG-PET FDG-PET FDG-PET confirms tumour mass reduction in same patient FAP-targeted PET Clinical effect of 177Lu-based, FAP-targeted therapeutic candidate in-licensed by Telix, in a patient with breast cancer. Response verified by FAP-targeted PET (above) and FDG-PET (right) using the diagnostic in-licensed by Telix. Patient representative scans - individual results may vary.
Frank Roesch, PhD Mainz, DE Clinical development led by renowned KOLs Broad community of supporters leading investigations 9 Renowned radiochemist in nuclear medicine Invented the 68Ga generator Chairs World Theranostics Conference Ken Herrmann, MD, MBA Essen, DE Chair of Dept of Nuclear Medicine at University Hospital Essen Chair of EANM Oncology & Theranostics Committee Prolific commentator in nuclear medicine community Frederik L. Giesel, MD, MBA Chair of Dept of Nuclear Medicine at Uni Düsseldorf Global leader in application of PSMA and FAP targeting in nuclear medicine Düsseldorf, DE “FAP-targeting is very exciting. In the past, we have been successful in treating primarily one cancer type with a certain asset or therapeutic agent. Here we have opened a new door to treat a variety of cancer subtypes – a pan tumour target and even beyond!” - Prof. Dr. Frederik L. Giesel “ Extensive clinical experience with all Roesch compounds Widely published in both JNM and other nuclear medicine publications Chandrasekhar Bal, MD & Sanjana Ballal, PhD New Delhi, IN
Large market opportunity Unmet need in bladder cancer 6th most common cancer in the U.S., significant unmet need 10 American Cancer Society, Key Statistics for Bladder Cancer, accessed October 2024. Mason. Eur Urol Open Sci. 2021. National Cancer Institute, Bladder Cancer Prognosis and Survival Rates, accessed October 2024. National Cancer Institute, Bladder Cancer Prognosis and Survival Rates, accessed October 2024. Targeted radionuclide therapy. Hemida et al. J Immunoassay Immunochem. 2022. NCCN Guidelines Version 4.2024, Bladder Cancer. White space opportunity for TRT5, including FAP-targeting agents Global market for bladder cancer therapies estimated to grow by over 20% per annum over next 5 years4 No approved systemic radionuclide therapy Studies suggest FAP expressed in over 67% of cases6 83K new cases and 16K+ deaths per year in the U.S.1 29% of patients develop metastatic disease2 with 5-year survival rate of 8%3 $5.6B $13.7B in 2024 in 2029
Adding to the bladder cancer therapy toolbox Complements Telix's CAIX program, options for localised and disseminated disease 11 ZiP-UP (IIT) Exploring indication expansion for TLX250 in urothelial carcinoma or bladder cancer Phase I study of TLX250-CDx complete – awaiting readout PERTINENCE (IIT) Alpha candidate in non-muscle invasive bladder cancer Phase I feasibility study of TLX250-CDx complete Moving to first-in-human therapeutic studies with 211At (alpha) via Telix partner ATONCO Trials of TLX250-CDx in bladder cancer TLX250-CDx-PET CT FDG-PET CT Contrasted CT 3D representation with superimposed bladder based on TLX250-CDx Pelvis PET/CT Fusion images Comparison of TLX250-CDx PET-CT with FDG-PET CT. Patient representative scans - individual results may vary.
Pan-cancer: “Double hit” at TME – targeting hypoxia and fibrosis A complementary approach – and a “shot in the arm” to immuno-oncology 12 FAP targeting small molecule (fibrosis / stroma) Two well validated targets with pan-cancer potential1, 2 Head and Neck Carcinoma Esophageal Cancer Chordoma Salivary Gland Cancer Thymus Cancer Breast Cancer Cholangiocarcinoma Sarcoma Renal Cell Carcinoma Ovarian Cancer Cervical Cancer Colorectal Cancer Anal Cancer Glioblastoma Multiforme Hepatocellular Carcinoma Desmoid Gastric Cancer Nasopharyngeal Carcinoma Lung Cancer Adenoid Cystic Carcinoma Thyroid Cancer Neuroendocrine Tumours Pancreatic Cancer Insulinoma Small Intestine Cancer Bladder Cancer Prostate Cancer FAP CAIX CAIX targeting antibody (hypoxia) Literature reports of CAIX expression. Giesel et al. J Nucl Med. 2019.
Clinically validated theranostic drug candidates targeting FAP – a highly promising target Next-generation compounds with longer tumour retention than earlier versions Adds to Telix’s urology development pipeline with novel candidates for bladder cancer, a major market opportunity Potential to generate further value from pan-cancer targeting Clinical data (safety profile and efficacy) reduce development risk, guide target indications and may expedite development Visit our website for more: Attack on Stroma In summary: An exciting asset with big potential Adds to urology pipeline with ability to expand to other cancer types 13 Kratochwil et al. 2019. Journal of Nuclear Medicine June 2019, 60 (6) 801-805; DOI: https://doi.org/10.2967/jnumed.119.227967 13 Maximum-intensity projections of 68Ga-FAPI PET/CT in patients reflecting 15 different histologically proven tumour entities (sorted by uptake in descending order). Ca = cancer; CCC = cholangiocellular carcinoma; CUP = carcinoma of unknown primary; MTC = medullary thyroid cancer; NET = neuroendocrine tumour. 68Ga-FAPI PET/CT: Tracer Uptake in 28 Different Kinds of Cancer1 SNMMI Image of the Year 2019 Patient representative scans - individual results may vary.
Contact details: Kyahn WilliamsonSVP Investor Relations and Corporate Communicationkyahn.williamson@telixpharma.com A confocal microscopy image of a fibroblast. Credit: National Cancer Institute.