Telix and Kanazawa University Cleared to Commence Prostate Cancer Imaging Study in Japan

Melbourne (Australia) and Kyoto (Japan) – 22nd February 2021. Telix Pharmaceuticals Limited (ASX.TLX) (‘Telix’, the ‘Company') announces today its subsidiary, Telix Pharmaceuticals Japan KK (‘Telix Japan’), in collaboration with Kanazawa University, has received Clinical Trial Notification (CTN) clearance by the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) to commence a Phase I trial of its prostate cancer imaging product TLX591-CDx (Kit for the preparation of 68Ga-PSMA-11 injection) in Japan.

In December 2020, Telix Japan commenced a clinical collaboration with Kanazawa University to conduct a Phase I trial of TLX591-CDx enrolling 10 patients with advanced prostate cancer. The purpose of the trial is to obtain preliminary clinical data in a suitable patient population, confirming that the targeting and pharmacology of TLX591-CDx is equivalent to non-Japanese patients. Such clinical data will support future planning discussions with the objective of PMDA product approval in Japan, aligning with the marketing authorisations that Telix has already submitted in the US, EU, Canada and Australia.

Prof. Seigo Kinuya, Professor of Nuclear Medicine at the Kanazawa University Hospital, Department of Nuclear Medicine, Chair of the Japanese Society of Nuclear Medicine, and Chair of the National Conference for Nuclear Medicine Theranostics stated, “ 68Ga-PSMA-11 has been studied widely and intensively across the globe outside of Japan. Clinical data have been accumulated and its diagnostic efficacy and clinical application have been well characterised in guidelines in nuclear medicine and urology, worldwide. This first clinical trial of 68Ga-PSMA-11 prostate imaging in Japan is a crucial milestone to pave the way to provide new diagnostics to Japanese prostate cancer patients.”

Telix Pharmaceuticals Japan K.K. President Dr. Shintaro Nishimura added, “This study is the first formal clinical trial in Japan of a gallium labeled PET imaging agent, which many Japanese nuclear medicine and urology physicians have been waiting for. We would like to express our appreciation to our pioneering colleagues at Kanazawa University's Departments of Nuclear Medicine and Urology, the Innovative Clinical Research Center of Kanazawa University Hospital, the Kanazawa Advanced Medical Center, ATOX Co. Ltd and IRE ELiT (Belgium) for their exceptional support and collaboration in this project.”

Czech Republic Grants National Authorisation for the Use of Telix’s Prostate Cancer Imaging Product

Melbourne (Australia) and Liège (Belgium) – 16th February 2021. Telix Pharmaceuticals Limited (ASX: TLX, ‘Telix’, the ‘Company’) announces today that the Ministry of Health of the Czech Republic is the first European health authority to grant a national authorisation allowing the use of TLX591- CDx (Kit for the preparation of 68Ga-PSMA-11), a radiopharmaceutical targeting Prostate-Specific Membrane Antigen (PSMA) for the imaging of prostate cancer using Positron Emission Tomography (PET). 

The national authorisation, which is specific to Telix’s prostate cancer imaging product, enables Czech physicians to use TLX591-CDx under a Specific Therapeutic Programme (STP), which allows medical products intended for the treatment, prevention or diagnosis of conditions severely affecting human health to be used prior to being granted a full European marketing authorisation.1 Telix is collaboratively pursuing such temporary approvals in a number of European countries, concurrent with marketing authorisation applications.

Under the STP authorisation, which is valid until 31st December 2022 TLX591-CDx is indicated for the diagnostic imaging of prostate cancer using PET/CT or PET/MRI for the purposes of:

        1. Primary staging of high-risk disease with a view to early identification of metastases

        2. Localisation of prostate cancer in patients with PSA progression following radical treatment2

        3. Identification of patients with extensive generalised prostate cancer for who radical life-saving treatment is not indicated

1   https://www.sukl.eu/pharmaceutical-industry/related-information

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Telix and Heidelberg University Hospital to Develop Next Generation Theranostics

Melbourne (Australia) and Heidelberg (Germany) – 10th February 2021. Telix Pharmaceuticals Limited (ASX: TLX, ‘Telix’, the ‘Company’) today announces it has concluded a research cooperation agreement with Heidelberg University Hospital in Germany (UKHD) to develop next generation theranostic radiopharmaceuticals for urologic oncology.

Under the terms of the agreement, Telix and UKHD will co-develop new conjugates and constructs for diagnostic and therapeutic (‘theranostic’) use.

The goal of the collaboration is to identify candidates and generate sufficient data to proceed to first in human (FIH) trials, with all candidates being evaluated in a pre-clinical study (in vitro and in vivo analysis, toxicology, and manufacturing suitable for clinical translation).

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Telix Pursues Direct Benelux Product Distribution

Telix Pharmaceuticals Limited (ASX: TLX, ‘Telix’, the ‘Company’) today announces it has elected to terminate its agreement with PI Medical Diagnostic Equipment B.V. (‘PI Medical’) for exclusive Netherlands distribution rights to TLX591-CDx (Kit for the preparation of 68Ga-PSMA-11 injection) for prostate cancer imaging, and non-exclusive rights in the Flemish region of Belgium. 1

Over the past twelve months, Telix has invested heavily in its European footprint, including the acquisition of a radiopharmaceuticals manufacturing facility in Seneffe (Belgium) in 2020.2 The Company’s clinical team has also been significantly expanded to deliver multiple clinical studies in Europe, including the ZIRCON3 and IPAX-14 studies. Telix now has a suitable network, production infrastructure and commercial team to distribute its own products in the Netherlands, including Illuccix® (TLX591-CDx), which is anticipated to receive an EU marketing authorisation this year, subject to regulatory approvals

1 ASX disclosure 2/07/19.

2 ASX disclosure 3/04/20.

3 A Ph III study of Telix’s renal cancer diagnostic product TLX250-CDx. ClinicalTrials.Gov Identifier: NCT03849118.

4 A Ph I/II study of Telix’s glioblastoma multiforme therapeutic product TLX101. ClinicalTrials.Gov Identifier: NCT03849105.

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Activity Report and Appendix 4C for Q4 2020

Financial Summary

• The Company held cash reserves of $79.09 million on 31 December 2020.

• An up-front non-refundable prepayment of $33.81 million, plus an equity investment of $35.1 million were received during the quarter following completion of a strategic licence and commercial partnership with China Grand Pharmaceutical and Healthcare Holdings Limited (CGP) for Greater China. (*1)

• Operating expenditure during the quarter included $7.93 million for R&D and clinical trial costs, as well as regulatory filing costs for Telix’s first product Illuccix® (TLX591-CDx), for the Positron Emission Tomography (PET) imaging of prostate cancer.

• Telix has sufficient capital reserves to launch its first two products Illuccix® (TLX591- CDx) and TLX250-CDx for prostate and renal cancer imaging, respectively (*2 ), and to fund ongoing clinical development costs in 2021 and 2022.(*3)

(*1)  ASX disclosure 2/11/20.

(*2)  Subject to approvals in the relevant jurisdictions. None of Telix’s products have attained a marketing authorisation in any country.

(*3)  Subject to timely commencement of revenues from product launch of Illuccix® (TLX591-CDx) in the US/EU.