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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

Promega scientists contribute to new research to improve precision and efficiency of groundbreaking gene editing technique MADISON, Wis.--(BUSINESS WIRE)-- A new study published in Nature Communications demonstrates how small molecule inhibitors can be used to improve the precision and efficiency of CRISPR-Cas9 gene editing. The results demonstrate how this groundbreaking technique can be enhanced by using two inhibitors to boost insertion rates and reduce off-target effects. Their findings are key to advancing the use of CRISPR techniques in research and clinical applications using a wide range of cell lines. Improved Genome Editing with CRISPR-Cas9 CRISPR-Cas9 is a genome editing technique that has become an indispensable tool in biomedical research since it was first unveiled in 2012. Researchers can use the technique to cut DNA at specific sites and insert or remove genetic material, enabling a level of genetic manipulation that was previously impossible. In the Nature Communications paper, the authors analyzed a library of 20,548 small molecules to develop strategies for improving this gene editing technique. They identified two inhibitors targeting the proteins DNA-dependent Protein Kinase (DNA-PK) and DNA Polymerase Theta (PolΘ) and demonstrated that the combination of these two molecules dramatically increased the performance of “knock-in” gene editing. This strategy, dubbed 2iHDR, outperformed previously described strategies that aimed to increase knock-in efficiency with small molecule inhibitors. This paper also documents a new system based on next-generation sequencing (NGS) that can be used to characterize the effects of inhibitors on CRISPR-Cas9. This open-access tool, which the authors named KI-Seq, enables researchers to analyze the contributions of different DNA repair pathways following CRISPR-Cas9 treatment. Unlike comparable tools, KI-Seq can be used with any cell type, including non-dividing primary cells. Promega research scientists Marie Schwinn and Michael Slater contributed to this research led by scientists from AstraZeneca. Read the paper, “Simultaneous inhibition of DNA-PK and Polϴ improves integration efficiency and precision of genome editing” Learn about Promega technologies that can be used with CRISPR-Cas9 at . About Promega Corporation Promega Corporation is a leader in providing innovative solutions and technical support to the life sciences industry. The company’s portfolio of over 4,000 products supports a range of life science work across areas such as cell biology; DNA, RNA and protein analysis; drug development; human identification and molecular diagnostics. These tools and technologies have grown in their application over the last 45 years and are used today by scientists and technicians in labs for academic and government research, forensics, pharmaceuticals, clinical diagnostics and agricultural and environmental testing. Promega is headquartered in Madison, WI, USA with branches in 16 countries and over 50 global distributors. Learn more at .

MELBOURNE, Australia I July 18, 2023 I Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company) today announces that the first patient has been dosed in a Phase I study of the Company's investigational targeted radiation therapy, TLX250, in combination with a Merck KGaA, Darmstadt, Germany (Merck) DNA-dependent protein kinase (DNA-PK) inhibitor candidate, peposertib (M3814). The study is being conducted in patients with solid tumours expressing carbonic-anhydrase IX (CAIX), a potential pan-cancer target. STARSTRUCK (ClinicalTrials.gov Identifier: NCT05868174 ) is a Phase Ib, open label, single-arm, multicentre dose escalation and dose expansion study to evaluate the safety profile, dosing and activity of TLX250 ( 177 Lu-DOTA-girentuximab) in combination with the DNA damage response inhibitor (DDRi) peposertib, which is an inhibitor of DNA-PK. The target population is patients with CAIX-expressing solid tumours that are relapsed or refractory to standard therapies. Up to 80 patients will be assessed in this study in Australian sites. The clinical hypothesis is that the combination of TLX250 and a DNA-PK inhibitor provides an enhancement in potency through their synergistic action on cancer cells. Targeted radiation effectively induces DNA damage in targeted cancer cells and the DNA-PK inhibitor may act to prevent the cell from repairing this damage, resulting in higher potency at lower doses. This hypothesis was confirmed in preclinical studies, conducted under a strategic research collaboration between Merck and Telix announced in 2019, [1] and provided evidence that the combined effect of Merck's investigational DNA-PK inhibitor peposertib with Telix's targeted radiation candidate has potential to significantly improve efficacy and reduce the required radiation dose for tumour reduction and remission, compared to targeted radiation alone. Principal Investigator for the STARSTRUCK study, Professor Nat Lenzo, GenesisCare Group Clinical Director Theranostics said, "The treatment of advanced cancer can be extremely challenging. We are pleased to support the commencement of this study with Telix to help determine if there is a potential future clinical benefit regarding the combination of molecular targeted radiation and DNA-PK inhibitors." Telix Chief Medical Officer, Dr. Colin Hayward stated, "Preclinical data has shown excellent combination response, which has potential to translate to additional response or more tolerable treatment regimens in patients. We would like to thank Prof. Lenzo and his clinical team at GenesisCare Murdoch, as well as the patients who will contribute to this important study." Merck and Telix are continuing the initial scientific collaboration to further explore and optimise the combination of TLX250 or other next-generation targeted radiation therapy candidates with Merck's DDRi compounds in preclinical studies. About TLX250 TLX250 ( 177 Lu-DOTA-girentuximab) is an antibody-based therapeutic platform that targets CAIX, a cell surface protein that is highly expressed in several human cancers, and is currently the subject of the STARLITE-1 (ClinicalTrials.gov Identifier: NCT05663710 ) and STARLITE-2 ( NCT05239533 ) studies in combination with immunotherapy. [2] High CAIX tumour expression is generally correlated with poor prognosis. Telix's companion investigational diagnostic imaging agent TLX250-CDx ( 89 Zr-DFO-girentuximab) was the subject of a successful global Phase III trial (ZIRCON trial, NCT03849118 ), which completed enrolment and reported positive top-line data during 2022. [3] Analyses of primary endpoints and key secondary endpoints of the ZIRCON trial were presented to the medical community for the first time at ASCO GU on 18 February 2023. [4] TLX250-CDx is currently being investigated in the Phase II STARBURST study (ClinicalTrials.gov Identifier: NCT05563272 ) exploring CAIX expression in patients with a diverse range of solid tumours for potential diagnostic and therapeutic applications. [5] About Telix Pharmaceuticals Limited Telix is a biopharmaceutical company focused on the development and commercialisation of diagnostic and therapeutic radiopharmaceuticals. 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 need in oncology and rare diseases. Telix is listed on the Australian Securities Exchange (ASX: TLX). 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 Twitter (@TelixPharma) and LinkedIn . TLX250 and TLX250-CDx have not received a marketing authorisation in any jurisdiction. Telix's lead product, Illuccix ® (gallium-68 ( 68 Ga) gozetotide (also known as 68 Ga PSMA-11) injection), has been approved by the U.S. Food and Drug Administration (FDA), [6] and by the Australian Therapeutic Goods Administration (TGA), [7] and by Health Canada. [8] Telix is also progressing marketing authorisation applications for this investigational candidate in the United Kingdom and the European Union. [9] [1] Telix ASX disclosure 1 August 2019. [2] Telix ASX disclosure 14 September 2021. [3] Telix ASX disclosure 7 November 2022. [4] Telix media release 20 February 2023. [5] Telix media release 19 June 2023. [6] Telix ASX disclosure 20 December 2021. [7] Telix ASX disclosure 2 November 2021. [8] Telix ASX disclosure 14 October 2022. [9] Telix ASX disclosure 3 April 2023. SOURCE: Telix Pharmaceuticals