Telix Pharmaceuticals Limited

ACN 616 620 369

Suite 401, 55 Flemington Road

North Melbourne

Victoria, 3051

Australia

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ASX RELEASE

Activities Report and Appendix 4C for December 2021 Quarter

Melbourne (Australia) - 24 January 2022. Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company) today provides its Appendix 4C quarterly cash flow statement and accompanying Activities Report for the quarter ended 31 December 2021. All figures are in AUD unless otherwise stated.

Financial Summary

  • Telix held cash reserves of $22.04 million on 31 December 2021 ($45.85 million held on 30 September 2021).
  • Net operating outflows during the quarter were $20.97 million, with total operating outflows of $21.96 million in line with forecasts. $6.96 million was invested in R&D and clinical development activities during the quarter.
  • Cash inflows during the quarter include $0.99 million in receipts from customers.
  • Subsequent to the end of the quarter, on 24 January 2022, the Company announced a $175 million institutional placement of new, fully paid ordinary shares in the Company at a price of $7.70 per New Share (Placement). The Placement will be followed by a Share Purchase Plan (SPP) to raise up to $25 million at the same offer price.

Activities Report

The December quarter culminated in the receipt of regulatory approval from the U.S. Food and Drug Administration (FDA) 1 for Telix's lead prostate cancer imaging product, Illuccix® (kit for the preparation of gallium-68 (68Ga) gozetotide (also known as PSMA-11) injection). This followed receipt of regulatory approval from the Australian Therapeutic Goods Administration (TGA) in November2.

Alongside ongoing clinical development activity across the Company's broad research pipeline and management of the final stages of the United States New Drug Application (NDA) process for Illuccix, preparations towards commercial launch in Australia and the United States remained a key area of focus in the December quarter. These preparations aim to ensure the seamless transition to commercial rollout from Q1 2022.

Dr. Christian Behrenbruch, Managing Director and Telix Group CEO said "To achieve our first regulatory approval- in both the United States and Australia - is a major achievement and marks our transition to a commercial-stage company. In the initial stages of launch we will focus on our existing users and possible early adopters to build a foundational customer base, as well as executing a wide-reaching market access and education campaign to nurture new customer sites and create demand, ahead of securing reimbursement status for Illuccix in the United States.

"The validation of our first regulatory approvals, the depth and quality of our clinical pipeline and our strength in supply chain and manufacturing uniquely positions Telix as a vertically-integrated leader in the global radiopharmaceutical industry. We look forward to progressing on all fronts in 2022 and further unlocking the value inherent in our pipeline."

  • ASX disclosure 20 December 2021.
    2 ASX disclosure 2 November 2021.

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Commercial Update

Illuccix (TLX591-CDx) regulatory approvals and commercial launch update

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Telix's lead prostate cancer imaging product has now received regulatory approval in the United States and Australia.

Telix's partner in Brazil, MJM Produtos Farmacêuticos e de Radioproteção LTDA (RPH), was also granted an exceptional authorisation from the Brazilian Health Regulatory Agency (Agencia Nacional de Vigilancia Sanitaria or 'Anvisa') allowing Illuccix to be marketed and sold in Brazil, ahead of full regulatory approval which is anticipated to be received in 2022.3

The Company is planning for a commercial launch in both the United States and Australia during Q1 2022, focused initially on existing users and early adopters (free-standing imaging centres and Veterans Affairs medical centres), prior to receipt of reimbursement codes. Combined with its partners, Telix has one of the largest commercial teams focused on PSMA-PET imaging in the United States and will have product available through at least 117 radio pharmacies in the initial stages of launch.

The Company's application for a distinct code from the Healthcare Common Procedure Coding System (HCPCS) was filed to meet the January 2022 deadline. A HCPCS code for Illuccix, which is used by commercial payors as well as the Centers for Medicare and Medicaid Services (CMS) to facilitate proper levels of reimbursement and to track utilisation, is expected to come into effect from 1 April 2022. Telix will also be applying for pass-through status, which secures a separate payment for a new FDA-approved radiopharmaceutical imaging agent for up to three years (and no less than two years). Pass-through only applies to CMS patients in the Hospital Outpatient Setting (HOPPS). The Company anticipates receipt of its pass-through code effective from 1 July 2022, pending acceptance of its submission.

As at the end of the quarter, marketing authorisation applications for TLX591-CDx) were under review and progressing in 15 countries (13 European Union Member States and United Kingdom, and Canada).

  • EU: The Marketing Authorisation Application (MAA) is being evaluated by the Danish Medicines Agency (DKMA) in its capacity as a Reference Member State, on behalf of the 13 European countries selected by Telix. The DKMA has indicated a decision notification will be provided no later than 23 March, 2022.
  • Canada: The Company's New Drug Submission (NDS) remains under review by Health Canada. A decision is expected within H1 2022.

European distribution agreements

In readiness for an approval decision notification and commercial launch, Telix has continued to build out its distribution network in Europe. During the quarter, Telix entered into an exclusive three- year commercial distribution agreement with NUCLIBER S.A.4 for Spain, an EU5 market. In Spain, prostate cancer is the most common cancer in men with approximately 34,600 patients diagnosed each year.5 This distribution agreement augments existing partnerships already in place for other major European markets.

  • ASX disclosure 1 December 2021.
    4 ASX disclosure 8 November 2021.
    5 Globocan 2021.

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Subsequent to the end of the quarter, Telix signed a three-year agreement with Biokosmos S.A. for exclusive distribution rights in Greece and Cyprus.

Both agreements are subject to usual termination rights, including a requirement to achieve minimum sales targets in any year following receipt of regulatory approval.

Development of regional business units and changes to leadership structure

To reflect the Telix Group's growth and strategy, Telix is building out its regional businesses and teams. In line with this objective, the Company has expanded regional leadership structures and elevated the roles of its regional Presidents to become Regional CEOs, with greater accountability for commercial growth and product life-cycle management in their respective regions. Mr. Richard Valeix is now Regional CEO, EMEA and Dr. David Cade, Regional CEO, Asia-Pacific.

Following the establishment of the Americas business and overseeing the receipt of the Company's first FDA approval, Dr. Bernard Lambert, President, Telix Americas, will transition to a technical consulting role for the Telix Group.

"As one of the first employees at Telix, Bernard has played an important role in establishing Telix in the Americas, and we have benefited from his experience and passion for scaling up an organisation from the start-up phase. We respect his decision to hand over the baton at this time in our evolution and look forward to continuing to work with him in a consulting and technical advisory capacity," said Dr. Behrenbruch.

Effective 2 February 2022, Dr. Christian Behrenbruch, Group CEO, will relocate to the United States to oversee the commercial launch of Illuccix and lead the Americas region until a new Regional CEO is appointed and onboarded. The company is currently considering several outstanding candidates for the role.

Quarterly sales (Illuccix / TLX591-CDx Kit)

The Company has continued to make TLX591-CDx available for investigational, clinical trial, magisterial and compassionate use access in accordance with local laws and regulations (not as a diagnostic imaging product in routine clinical practice).

In the December 2021 quarter, Telix delivered approximately 3,750 individual patient prostate cancer imaging doses, prepared from 1,528 TLX591-CDx prostate cancer imaging kits, representing a 39% increase compared to the corresponding quarter in 2020. Pre-approval sales recorded during the quarter totalled $1.50 million. The Company received $0.99 million in cash from pre-approvalTLX591-CDx kit sales in the quarter.

Telix notes that the sales of the TLX591-CDx kit during the quarter are not indicative of a reimbursed diagnostic imaging product volume or pricing.

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Clinical Programs Update

Telix continues to progress its clinical pipeline, with a core focus on prostate, kidney and brain cancer and rare diseases (bone marrow conditioning). The Company has 18 clinical trials underway, including investigator-led studies.

The table, on the following pages, highlights key clinical progress and activity during the quarter, further details can be found in the original ASX or press release disclosures.

Asset

Prostate Cancer / PSMA

Prostate cancer therapy: TLX591

ProstACT study program6

NOBLE registry: TLX599- CDx

Registry study

Activity

Patient recruitment for the ProstACT group of studies has commenced at Australian sites, with initial focus on ProstACT SELECT. ProstACT GLOBAL remains a key priority with manufacturing and clinical readiness for patient recruitment initially in Australia on the basis of the current TGA-approved study, with expansion to the United States, Europe in 1H 2022, subject to regulatory approvals. The Company also anticipates recruiting patients in China in cooperation with China Grand Pharma.

Recruitment of Australian patients from rural Western Australia into the NOBLE registry study has commenced. The NOBLE (Nobody Left Behind) Registry is collecting clinical data to inform the development of TLX599-CDx (99mTc-iPSMA),aninvestigational prostate cancer imaging agent that targets PSMA (prostate specific membrane antigen) using single photon emission computed tomography (SPECT). An additional site in Jakarta, Indonesia has also been added to the study, which is now active across six sites globally.

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Kidney Cancer / CA9

Clear Cell Renal Cell Carcinoma (ccRCC) imaging: TLX250-CDx

ZIRCON Phase III Study

ccRCC therapy: TLX250

STARLITE 1 & 2 Phase II studies7

Potential indication expansion: TLX250 in

Recruitment into this study is now entering the final stages and has exceeded 85%. The Biologics License Application (BLA) process with the FDA via a pre-BLA consultation has commenced, as the Company progresses a regulatory filing.

Following receipt of Investigational New Drug Application (IND), in the previous quarter, patient screening has commenced in the STARLITE 2 study - a single arm, investigator-led Phase II study in patients with advanced ccRCC. The study will evaluate TLX250-delivered radiation as an immune system "primer" in combination with the anti-PD-1 immunotherapy nivolumab.

An IND has also been granted for an additional kidney cancer therapy study - STARLITE 1 - and is awaiting ethics approval.

A first patient has been dosed in a Phase II OPALESCENCE study of TLX250-CDx(89Zr-DFO-girentuximab) in patients with triple-negative breast cancer (TNBC) at the Institut de

  • ASX disclosure 19 August 2021.
  • ASX disclosure 14 September 2021.

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Asset

triple-negative breast cancer (TNBC)

OPALESCENCE Phase II study8

Potential indication expansion: TLX250 in non- muscle-invasive bladder cancer (NMIBC)

PERTINENCE Phase I study9

Activity

Cancérologie de l'Ouest (ICO) in St Herblain, France.

OPALESCENCE is the second in a comprehensive series of studies that will evaluate CA9 expression in cancers other than ccRCC, supporting Telix's goal to rapidly expand the CA9 program into other indications.

A first patient has been dosed in the Phase I PERTINENCE study, an investigator-led,open-label, proof of concept study to evaluate safety, biodistribution and dosing properties of TLX250-CDx in patients with NMIBC. The PERTINENCE study builds on the Telix and ATONCO licence and development agreement announced in December 2019.10

This study is aligned with Telix's goal to expand the indications for TLX250 and develop alpha therapy candidates. A successful outcome in this study will lead to therapeutic studies with astatine-211 (211At) for targeted alpha therapy (TAT).

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Brain Cancer

Recurrent glioblastoma multiforme (RGM) imaging: TLX101-CDx

FIG study11

Recurrent glioblastoma multiforme (RGM) therapy: TLX101

IPAX-1 Phase I/II study13

Telix entered into a clinical data access agreement with the Olivia Newton-John Cancer Research Institute (ONJCRI) relating to the use of FET-PET12 in Glioblastoma (FIG) Study, a prospective, multicentre study

which aims to definitively establish the role of FET-PET in the management of glioblastoma, a type of brain cancer. 18F-FET(TLX101-CDx) is under development by Telix as a

complementary diagnostic agent to its TLX-101 glioblastoma therapeutic candidate. The data from the FIG study may be used to support global regulatory submissions for TLX101-CDx. It is also expected that the clinical data will be publicly disseminated to benefit patients.

Based on the previously reported results of the IPAX-1 study, which were presented at the Congress of Neurological Surgeons (CNS) Annual Meeting on 19 October 2021 (United States time), Telix is planning a follow-on Phase I/II study in an earlier line of therapy.

The protocol for a Phase I/II study in frontline post-surgery in combination with standard of care and using Telix's TLX101- CDx (18F-FET) investigational agent as a complementary diagnostic has now been finalised and the Phase I component of this study will commence in Q1 2022, pending ethics approval.

Rare Diseases / Bone Marrow Conditioning

  • ASX disclosure 5 October 2021.
  • ASX disclosure 12 December 2021. 10 ASX disclosure 16 December 2021.
    11 Media release 22 December 2021; ANZCTR Trial ID: ACTRN12619001735145.
    12 O-(2-[18F]fluoroethyl)-L-tyrosine or 18F-FET to image glioblastoma patients with positron emission tomography (PET) (FET-PET).
    13 ASX disclosure 20 October 2021.

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Telix Pharmaceuticals Ltd. published this content on 23 January 2022 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 23 January 2022 22:13:06 UTC.