Telix Pharmaceuticals Ltd — Interim / Quarterly Report 2018

Jul 25, 2018

Telix Pharmaceuticals Limited (ASX:TLX)

Quarterly Program Update

26[th] July 2018

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Notices

The information contained in the 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. No representation or warranty, express or implied, is made in relation to the accuracy or completeness of the information contained in this document or opinions expressed in the course of this presentation. The information contained in this presentation is subject to change without notification.

This presentation contains forward-looking statements which can be identified by the use of words such as “may”, “should”, “will”, “expect”, “anticipate”, “believe”, “estimate”, “intend”, “scheduled” or “continue” or similar expressions. Any forward-looking statements contained in this presentation are subject to significant risks, uncertainties, assumptions, contingencies and other factors (many of which are outside the control of, and unknown to Telix, and its officers, employees, agents or associates), which may cause the actual results or performance to be materially different from any future result so performed, expressed or implied by such forward-looking statements.

There can be no assurance or guarantee that actual outcomes will not differ materially from these statements. The data and results pertaining to clinical subjects used in this presentation are illustrative of medical conditions and outcomes associated with potential applications of Telix’s product pipeline. Actual results from clinical trials may vary from those shown.

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Executive Summary

Significant progress over the last quarter:

• TLX101 (Brain Cancer)

• ➢ Phase I/II therapeutic trial successfully submitted in EU (28/06/18)

• ➢ Ethics review complete with minor changes (20/06/18)

• ➢ Trial expected to commence recruiting patients mid-Aug ‘18

• TLX250 (Kidney Cancer)

• ➢ Phase III[89] Zr imaging bridging study is recruiting very nicely (4/10 patients) Expected to complete end-Q3

• ➢ Phase III imaging IMPD (EU) : target filing date 13/08/18

• TLX591 (Prostate Cancer)

• ➢ Successful FDA review of Drug Master File (DMF) for prostate imaging agent

• ➢ Memorial Sloan Kettering / Endocyte authorized to reference DMF (1,250 patients)

• ➢ Telix USA will commence commercial launch of prostate imaging kit in Q3

• ➢ Manufacturing progressing well for TLX591 (antibody) – therapy program

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Snapshot of Current Clinical Trial Activity

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TLX250 (renal): Zir conium Dos im e try

• 89Zr-DFO-Girentuximab imaging

• 10 patients : 5 x 5mg (1mCi), 5 x 10mg (1mCi)

• Single site : Radboud University Medical Centre (bridging study)

• Pharmacokinetics / dosimetry, as required for US and EU product dossier (isotope change)

• • Completion target : end-Q3 ‘18

TLX250 (renal): Z irconium I maging in R enal C ancer On ocology

• 89 Zr-DFO-Girentuximab imaging (10mg/1mCi).

• Global Phase III (EU/US/AU), ~250 patients

• 15 sites EU, 2-3 sites Aus, 6-8 sites US

• Patients imaged prior to surgical resection, comparison with histology

• Completion target : Q3-’19 or sooner (depends on site ramp-up)

TLX101 (brain) : IPA + e X ternal beam radiation

• 4-L-[[131] I]iodo-phenylalanine ([131] I-IPA).

• Multi-centre (EU/AUS) Phase I/II, up to 55 patients

• 6 EU sites (Austria/Germany/Switzerland/Netherlands) + up to 3 Australian sites

• Combination therapy study with TLX101 and external beam radiation / standard care

• Completion target (Phase I /dose escalation component) : mid-2019

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TLX250 Program (Renal Cancer)

• :

• Imaging ([89] Zr-DFO-Girentuximab)

• Phase III[89] Zr bridging study ( EudraCT/IND no. 2017-004769-2 )

  • Recruiting faster than expected (Radboud). 4/10 patients imaged

  • Expect to complete by end-calendar Q3

• Phase III study ( EudraCT/IND no. 2018-002773-21 )

  • Phase III dossier (IMPD) filing target : 13[th] of August (15 EU sites)

  • CTN to follow shortly after for Australian patients (2-3 sites)

  • Planning in progress for an FDA meeting late Oct/early Nov (6-8 US sites)

  • Expect first patients in mid-Oct, subject to final EMA feedback

• : Therapy ([177] Lu-DOTA-Girtenxuimab)

• Three combo (+ checkpoint inhibitor) studies planned, including a likely pharmasponsored study (in active discussion)

• Clinical grade material will complete manufacturing ~end-Aug

• Targeting 2 x IND filings in calendar Q4 (Australia/USA)

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TLX591 Program (Prostate Cancer)

• :

• Imaging ([68] Ga-HBED-PSMA-11) – Prostate Imaging “Kit”

• FDA has reviewed Drug Master File (DMF ID 032631)

• MSKCC has launched 500 patient expanded-access Phase II study ( NCT03204123 )

• Telix is providing prostate imaging for Endocyte’s (NASDAQ : ECYT) VISION trial ( NCT03511664 ) – through the Telix/ANMI JV (Kyzeo Imaging, LLC)

• Telix USA will commercially launch the prostate imaging kit in calendar Q3

• Several active distributor discussions – expected to conclude by end-August

• Significant clinical interest / demand from over 50 US cancer centres to date

• :

• Therapy ([177] Lu-DOTA-TLX591)

• First material ready by end-2018 for toxicology and human biodistribution studies

• Planning in progress to conduct initial biodistribution/pharmacology studies for TLX591 (engineered huJ591) in Australia

• Australian/US multi-centre Phase II study on track for launch mid-2019 (8-10 sites)

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TLX101 Program (Glioblastoma)

• Therapy ([131] I-TLX101) : EudraCT/IND no. 2018-002262-3

• Ethics package successfully reviewed (Linz/Vienna) with only minor changes / recommendations

• IMPD expected to be allowed in the next few weeks

• Strong clinician interest in the study because of the lack of effective treatments in this patient population

• Planning to file a Clinical Trial Notification (CTN) with TGA by end-August to allow the inclusion of Australian sites into the study

• Targeting a total of 6 sites in Europe – sites are in contracting

• Up to 3 sites in Australia under discussion and will be finalized in the next month

• Manufacturing improvements mean that the product now has >96 hour stability and can be shipped globally for clinical trials from manufacturing site (Seibersdorf)

• Shipment to Australia already validated and ARPANSA permits in place

• First patient in (FPI) expected mid-August

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Atlab SAS Acquisition : Transaction Status

• Final diligence / transaction matters are nearly complete

• Additional time was necessary to transfer / re-negotiate certain vendor and IP agreements, given change of control

• Last remaining items are expected to be finalized in the next 2 weeks, followed by a 20-day period for Atlab shareholders to approve final transaction terms as agreed between the parties

• Subject to all closing conditions and approvals, Telix expects the transaction to complete end-August or early-September

• In the meanwhile, Telix has:

• ✓ Continued to deliver on its obligations under the manufacturing agreement with Atlab, as described in the IPO prospectus

• ✓ Engaged an external CRO to (successfully) audit key therapeutic clinical data relating to the transaction (summary will be released as part of transaction close)

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Catalysts

• Date Activity •

• Mid-Aug Approval of IPAX-1 study, launch of brain cancer trial • Phase III submission for ZIRCON study

• •

• End-Aug Commercial / distributor roadmap for first revenues from prostate imaging kit

• • Addition of Australian sites to IPAX-1

• • Completion of Atlab transaction and release of prostate cancer therapy data summary

• •

• Early-Sept Completion of manufacturing for TLX250 therapy studies – roadmap update for RCC therapy program

• •

• Late-Sept Regulatory update on Phase III submission (Europe and Australia) for ZIRCON study

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