BAY-867548

MELBOURNE, Australia, Oct. 18, 2023 /PRNewswire/ -- Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company) today issues its Appendix 4C quarterly cash flow report and accompanying Activities Report for the quarter ended 30 September 2023 (Q3 2023). All figures are in AUD$ unless otherwise stated[1] and provided on an unaudited basis. Summary Total revenue of $133.6M, up from $120.7M (Q2 2023) Fourth consecutive quarter of positive operating cash flow ($21.4M, up $10.6M on the prior quarter) Cash receipts from customers up 16% to $130.7M ($112.2M in the prior quarter) Closing cash balance of $137.4M (compared to $131.7M at prior quarter end) Managing Director and Group CEO, Dr Christian Behrenbruch commented, "The achievement of a fourth consecutive quarter of positive operating cash flow is a major milestone that reflects the Company's maturation as it delivers on its commercial goals and progresses the development of its industry-leading pipeline. "We have posted another quarter of double-digit revenue growth for Illuccix in the U.S. with average daily demand for doses continuing to grow month-on-month. Just as importantly we have a number of near-term value drivers on the horizon, being the commencement of the ProstACT GLOBAL study and advancing the U.S. regulatory filing and commercial launch preparations for our renal (kidney) and brain cancer imaging agents. This is reflected in our investment during the quarter in research and development and commercial launch preparation, in line with our stated plans." Commercial Activities Report Americas region: United States (U.S.) and Canada Revenue from U.S. sales of Illuccix (kit for the preparation of gallium Ga 68 gozetotide injection) improved 13% to $130.6M (US$85.2M), up from $116.0M in Q2 2023. Worldwide revenue Total revenue of $133.6M was generated during the quarter (including commercial sales of Illuccix in the U.S.). Ex-U.S. revenue (including compassionate use availability of Illuccix / TLX591-CDx)[2] was $3.0M.[3] Net cash from operating activities Telix delivered its fourth consecutive quarter of positive net operating cash inflow. The net operating cash inflow for the quarter was $21.4M, a $10.6M improvement on the prior quarter (Q2 2023, net operating cash inflow $10.8M). In line with increased revenue and improved collections, cash receipts from customers improved 16% to $130.7M, up from $112.2M in the prior quarter. The closing cash balance at 30 September 2023 was $137.4M ($131.7M 30 June 2023). The net operating cash inflow was partially offset by cash outflows from investing activities which included an annual payment of $17.8M for the first instalment of the contingent consideration payable to former Telix Innovations (ANMI) shareholders, based on Illuccix sales. Increased product manufacturing and related costs reflect higher volume of sales activity and preparation for future product launches. Gross margin is broadly in line with the previous quarter at 63% and reflects stable selling prices and manufacturing costs. R&D expenditure[4] is in line with plan and reflects the momentum in the key near-term value drivers for the Company being the commencement of the ProstACT GLOBAL study and advancing the U.S. regulatory filings for the TLX250-CDx Biologics License Application (BLA) and TLX101-CDx New Drug Application (NDA). Illuccix global regulatory update Telix is progressing new marketing authorisations for Illuccix in a number of jurisdictions, including the United Kingdom (U.K.), European Union (E.U.)[5] and Brazil. As previously reported, these respective applications are currently undergoing assessment and the Company will provide an update on any material changes to status. A Phase III study intended to bridge to the marketing authorisation granted to Illuccix by the United States Food and Drug Administration (FDA) is in progress and recruiting well in China.[6] During the quarter the Company participated in a formal pre-NDA meeting with the Japanese regulator, the Pharmaceuticals and Medical Devices Agency (PMDA) as part of its preparation towards a regulatory filing for Illuccix in Japan. The outcome was clear and helpful feedback to support a regulatory submission of Illuccix in Japan in 2024. Clinical Programs Update Telix has an industry leading pipeline of late-stage radiopharmaceutical therapeutics and associated diagnostic imaging agents, underpinning its commitment to targeted, precision oncology. The core pipeline is focused on prostate cancer, renal cancer, brain cancer (glioma) and rare diseases (hematologic cancers and bone marrow conditioning). The Company has over 20 clinical studies underway worldwide, including Telix-sponsored and collaborative investigator- initiated trials. During the quarter, notable updates were published in the news section of the Company's website () and are summarised in this section of the Activities Report. Priority focus areas for the clinical pipeline: Progression of the prostate cancer therapy program (TLX591, Lutetium ( 177 Lu) rosopatamab tetraxetan): The Phase III ProstACT GLOBAL study (ClinicalTrials.gov ID: NCT04876651) is now open for enrolment in Australia, with additional sites in the Asia Pacific region currently being onboarded. The study is expected to open for enrolment in the U.S. following acceptance of an investigational new drug (IND) application, scheduled for filing in Q4 2023. Preparation of a BLA submission and commercialisation of TLX250-CDx ( 89 Zr-DFO-girentuximab), Telix's investigational kidney cancer imaging agent: As supported under the Breakthrough Therapy designation, the Company is actively engaging with the FDA as it prepares its regulatory filing. The Company has received a formal acceptance letter from the FDA in response to a request for a rolling review of the BLA. This is an important positive development, which allows the applicant to submit portions of a BLA or NDA separately, when corresponding data becomes available. This enables the FDA to consider reviewing key modules in advance of receiving the entire application, making the review process more efficient and potentially shortening the overall review period. The Company continues to progress its BLA submission in 2023 as planned. Telix has obtained clearance to commence its Expanded Access Program (EAP) in the U.S. with multiple sites now actively screening patients. Compassionate use access programs are active in Europe and Australia, to provide TLX250-CDx to patients and physicians in areas of unmet need, prior to obtaining marketing authorisation in accordance with the applicable permitted regulatory pathways. The Company is also conducting new research and clinical studies to explore the theranostic utility of this investigational asset in other cancers expressing carbonic anhydrase IX (CAIX), where there are currently high unmet medical needs. Preparation of a NDA submission for TLX101-CDx ( 18 F-FET), Telix's investigational brain cancer imaging agent: Telix has significantly progressed the NDA filing for TLX101-CDx, including formal consultation with the FDA around the final proposed clinical package. Based on this feedback, the NDA submission will occur in Q1 2024 in order to enable Telix to include additional clinical data (already in possession). In addition to this, the Company has filed an application to commence an EAP in the U.S. that is expected to open for patient access in November 2023, subject to regulatory clearance. CAIX program (TLX250-CDx / TLX250): Multiple studies underway to support theranostic indication expansion Telix has multiple clinical studies in its CAIX program, exploring the potential of this target in combination with immunotherapy for the treatment of ccRCC and also its potential across a broad range of cancer indications. CAIX is a protein overexpressed on the surface of ccRCC, the cancer target in Telix's successful Phase III ZIRCON study. It is also expressed to varying degrees in many other advanced-stage solid tumours with poor prognoses. The first patients have now been dosed in the STARSTRUCK therapeutic study (ClinicalTrials.gov ID: NCT05868174) of TLX250 (177Lu-DOTA-girentuximab) in combination with a Merck KGaA, Darmstadt, Germany DNA-dependent protein kinase (DNA-PK) inhibitor candidate, peposertib (M3814).[7] The open label, single-arm, multi-centre dose escalation and dose expansion study is evaluating safety profile, dosing and activity and will enrol up to 80 patients with CAIX- expressing solid tumours. The Phase II OPALESCENCE investigator-initiated trial (IIT) of TLX250-CDx in triple-negative breast cancer (ClinicalTrials.gov ID: NCT04758780) has completed enrolment with top-line data anticipated shortly. TLX101 brain cancer (glioblastoma) therapy program update Dosing of the first cohort of patients has been completed in the Phase I IPAX-2 study of TLX101 (4-L-[131I] iodo- phenylalanine, or 131I-IPA), running at sites across Australia, New Zealand and Europe. IPAX-2 (ClinicalTrials.gov ID: NCT05450744) seeks to confirm the safety profile of TLX101 as a front-line therapy in combination with standard of care (SoC) treatment, ahead of progressing to a label-indicating Phase II/III study in a larger patient population, IPAX-3. In parallel, building on the success of Telix's Phase I/II IPAX-1 study (ClinicalTrials.gov ID: NCT03849105),[8] TLX101 is being further investigated in the recurrent setting in the Phase II IPAX-Linz IIT, which is progressing well and has now exceeded 70% of the patient enrolment target. Grand Pharma partnership: First patients dosed in Chinese imaging studies Two studies are being conducted in collaboration with the Company's strategic partner for the Greater China region, Grand Pharmaceutical Group Limited to demonstrate that the diagnostic utility of TLX591-CDx and TLX250-CDx is equivalent in Chinese and Western populations. The data generated will support future marketing authorisation applications for the Company's prostate and renal cancer imaging agents in China. During the quarter, patient dosing commenced in the Phase III registration study of TLX591-CDx (Illuccix) (ClinicalTrials.gov ID: NCT05847348)[9] and additional sites were opened. Related Party Transactions Telix confirms that payments noted under section 6.1 of the accompanying Appendix 4C include payments of $0.3M to ABX-CRO advanced pharmaceutical services (of which Non-Executive Director Dr Andreas Kluge is Managing Director) for the provision of clinical and analytical services for the Company's development programs. Payments of $0.3M were made to Directors for Director fees and Managing Director salary. Investor Call An investor webcast will be held at 8.30am AEDT on Thursday 19 October (Wednesday 18 October, 5.30pm EDT) Participants can register for the webcast and find audio call details at the following link: server.com/mmc/p/b3jsi4g4 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- 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). 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 LinkedIn. Telix's lead product, Illuccix® or kit for preparation of gallium-68 (68Ga) gozetotide (also known as 68Ga PSMA-11) injection, has been approved by the FDA,[10] by the Australian Therapeutic Goods Administration (TGA), [11] and by Health Canada.[12] Telix is also progressing Marketing Authorisation Applications for 68Ga PSMA-11 in the United Kingdom, the European Union,[13] and Brazil. With the exception of Illuccix as noted above, no Telix product has received a marketing authorisation in any jurisdiction. Telix Investor Relations Ms. Kyahn Williamson Telix Pharmaceuticals Limited SVP Investor Relations and Corporate Communications Email: [email protected] This announcement has been authorised for release by the Telix Pharmaceuticals Limited Disclosure Committee on behalf of the Board. Legal Notices This announcement is not intended as promotion or advertising directed to any healthcare professional or other audience in any country worldwide (including Australia, United States and the United Kingdom). This announcement may include 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", "outlook", "forecast" and "guidance", or other similar words. 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 the Company's good-faith assumptions as to the financial, market, regulatory and other risks and considerations that exist and affect the Company'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 studies, 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, manufacturing activities and product marketing activities; the commercialisation of Telix's product candidates, if or when they have been approved; 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. Except as required by applicable laws or regulations, Telix does not undertake to publicly update or review any forward- looking statements. Past performance cannot be relied on as a guide to future performance. Readers should read this announcement together with our material risks, as disclosed in our most recently filed reports with the ASX and on our website. ©2023 Telix Pharmaceuticals Limited. The Telix Pharmaceuticals and Illuccix name and logo are trademarks of Telix Pharmaceuticals Limited and its affiliates (all rights reserved). SOURCE Telix Pharmaceuticals Limited

Highlights IND approval received for SAR-Bombesin product, enabling a Phase II "SABRE" imaging trial to detect prostate cancer in up to 50 PSMA-negative participants in the US Approximately 20% of prostate cancer patients with biochemical recurrence (BCR) are PSMA-PET negative and therefore unsuitable for the currently approved PSMA targeting agents, presenting an opportunity to target these cancers with Clarity's SAR-Bombesin product SYDNEY, June 6, 2022 /PRNewswire/ -- Clarity Pharmaceuticals (ASX: CU6) ("Clarity"), a clinical-stage radiopharmaceutical company developing next-generation products to address growing medical needs in oncology, announces the approval of its Investigational New Drug (IND) application by the United States Food and Drug Administration (US FDA) to evaluate its SAR-Bombesin product as an imaging agent in prostate cancer patients that are Prostate-Specific Membrane Antigen (PSMA)-negative. Clarity's Executive Chairman, Dr Alan Taylor, commented, "Receiving clearance from the FDA on the imaging trial with SAR-Bombesin is yet another significant milestone for Clarity. It shows our ability to develop cutting-edge theranostics from the lab, through preclinical studies and into clinical trials, with SAR-Bombesin being Clarity's fourth IND across five products which are clear for investigation in the US." This IND gives Clarity clearance to proceed with a US-based Phase II 64Cu SAR-Bombesin Positron Emission Tomography (PET) imaging trial in participants with PSMA-negative biochemical recurrence (BCR) of prostate cancer following definitive therapy (such as surgery or radiation). SABRE, which derives from "Copper-64 SAR-Bombesin in Biochemical REcurrence of Prostate Cancer trial", is a multi-center, single arm, non-randomised, open-label trial in up to 50 PSMA-negative patients with known or suspected prostate cancer. The primary objectives of the trial are to investigate the safety and tolerability of 64Cu SAR-Bombesin, as well as its ability to correctly detect the recurrence of prostate cancer. The SABRE trial builds upon the promising clinical data from the pilot trial assessment of 64Cu SAR-Bombesin in breast cancer led by Prof Louise Emmett of St Vincent's Hospital Sydney. The data from this trial was recently presented at the prestigious American Society of Clinical Oncology (ASCO) 2022 Annual Meeting. The SABRE trial was developed in response to the strong demand for this product from clinicians with prostate cancer patients whose cancer was not visible with currently approved PSMA diagnostic agents or conventional imaging (such as CT and/or MRI). Their patients were successfully imaged with 64Cu SAR-Bombesin under a Special Access Scheme. Approximately 20% of prostate cancers with BCR are PSMA-PET negative1-4. These patients are therefore unlikely to respond to therapeutic PSMA-targeted products and currently have few treatment options available to them. Given the prostate cancer indication is one of the largest in oncology, there is a significant unmet medical need in this segment. The SAR-Bombesin product targets the Gastrin Releasing Peptide receptor (GRPr) found on prostate and many other cancers. As such, the product could offer valuable imaging and therapeutic options for not only PSMA negative patients, but also the large number of patients that have the target receptor on their cancers. "We look forward to further progressing the development of SAR-Bombesin and hope it will provide a new and effective diagnostic option for prostate cancer patients. Building on the promising clinical and preclinical data acquired to date, we are also planning an IND submission for a theranostic trial in prostate cancer participants, using 67Cu SAR-Bombesin therapy paired with the imaging agent, 64Cu SAR-Bombesin. Combined with the clinical, environmental and logistical benefits enabled by the copper isotope pairing, SAR-Bombesin has potential to provide this large patient population with accurate and precise detection and treatment of prostate cancer. We anticipate the SABRE trial to commence shortly and the theranostic trial to commence in 2023," Dr Taylor added. This announcement has been authorised for release by the Executive Chairman. For more information, please contact: About Clarity Pharmaceuticals Clarity is a clinical stage radiopharmaceutical company focused on the treatment of serious disease. The Company is a leader in innovative radiopharmaceuticals, developing targeted copper theranostics based on its SAR Technology Platform for the treatment of cancer in children and adults. About SAR-Bombesin SAR-Bombesin is a highly targeted pan-cancer radiopharmaceutical with broad cancer application. It targets the gastrin-releasing peptide receptor (GRPr) present on cells of a range of cancers, including but not limited to prostate, breast and ovarian cancers. GRPr is found in approximately 75-100% of prostate cancers, including prostate cancers that don't express PSMA (PSMA-negative)5-9. The product utilises Clarity's proprietary sarcophagine (SAR) technology that securely holds copper isotopes inside a cage-like structure, called a chelator. Unlike other commercially available chelators, the SAR technology prevents copper leakage into the body. SAR-Bombesin is a Targeted Copper Theranostic (TCT) that can be used with isotopes of copper-64 (Cu-64 or 64Cu) for imaging and copper-67 (Cu-67 or 67Cu for therapy). About Prostate Cancer Prostate cancer is the second most common cancer diagnosed in men globally and the fifth leading cause of cancer death worldwide10. The National Cancer Institute estimates in 2022 there will be 268,490 new cases of prostate cancer in the US and around 34,500 deaths from the disease11. References Afshar-Oromieh A, Holland-Letz T, Giesel FL, et al. Diagnostic performance of 68Ga-PSMA-11 (HBED-CC) PET/CT in patients with recurrent prostate cancer: evaluation in 1007 patients. Eur J Nucl Med Mol Imaging. 2017 Aug;44(8):1258-1268. Ferraro DA, Rüschoff JH, Muehlematter UJ, et al. Immunohistochemical PSMA expression patterns of primary prostate cancer tissue are associated with the detection rate of biochemical recurrence with 68Ga-PSMA-11-PET. Theranostics. 2020;10(14):6082-6094. Baratto L, Song H, Duan H, et al. PSMA- and GRPR-Targeted PET: Results from 50 Patients with Biochemically Recurrent Prostate Cancer. J Nucl Med. 2021;62(11):1545-1549. Mapelli P, Ghezzo S, Samanes Gajate AM, et al. 68Ga-PSMA and 68Ga-DOTA-RM2 PET/MRI in Recurrent Prostate Cancer: Diagnostic Performance and Association with Clinical and Histopathological Data. Cancers (Basel). 2022;14(2):334. Markwalder R, Reubi JC. Gastrin-releasing peptide receptors in the human prostate: relation to neoplastic transformation. Cancer research. 1999;59(5):1152-1159. Fleischmann A, Waser B, Reubi JC. High expression of gastrin-releasing peptide receptors in the vascular bed of urinary tract cancers: promising candidates for vascular targeting applications. Endocrine-related cancer. 2009;16(2):623-633. Ananias HJ, van den Heuvel MC, Helfrich W, de Jong IJ. Expression of the gastrin-releasing peptide receptor, the prostate stem cell antigen and the prostate-specific membrane antigen in lymph node and bone metastases of prostate cancer. The Prostate. 2009;69(10):1101-1108. Reubi JC, Wenger S, Schmuckli-Maurer J, Schaer JC, Gugger M. Bombesin receptor subtypes in human cancers: detection with the universal radioligand (125)I-[D-TYR(6), beta-ALA(11), PHE(13), NLE(14)] bombesin(6-14). Clin Cancer Res. 2002;8(4):1139-1146. Sun B, Halmos G, Schally AV, Wang X, Martinez M. Presence of receptors for bombesin/gastrin-releasing peptide and mRNA for three receptor subtypes in human prostate cancers. The Prostate. 2000;42(4):295-303. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries American Cancer Society, Cancer Statistics Center, SOURCE Clarity Pharmaceuticals