Telix Pharmaceuticals Ltd — Interim / Quarterly Report 2018

Oct 30, 2018

Telix Pharmaceuticals Limited (ASX:TLX)

Q3 Program Update

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October 2018

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

Progress with manufacturing and distribution partnerships:

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• North America : Isologic (Canada), Cardinal Health (USA)

• Europe : RTM (Netherlands), Seibersdorf Laboratories (Austria)

• Japan : JFE Engineering and Nihon Medi-Physics

• Australia/Asia : Cyclotek, GenesisCare

Key clinical trials progressing well:

• ZIR-DOSE bridging study : 80% complete; 25% less radiation dose with[89]

[124] I

• ZIRCON PhIII study : first site approved in Australia, EU not far behind

• IPAX-1 PhI/II study : first EU sites approved, Australia to follow before year-end

First revenues from illumet[TM] prostate imaging cold kit in calendar Q4 (US market*)

(Kit for the preparation of[68] Ga-HBED-CC-PSMA11)

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*Investigational use only

Pipeline Overview

	Isotope	Target	Agent	Phase I		Phase II Phase III		Commercial
Kidney	177Lu 89Zr	CA-IX CA-IX	Antibody Antibody	TLX250 (Girentuximab) TLX250-Cdx (Girentuximab) Therapy				Imaging
Prostate	177Lu 68Ga	PSMA PSMA	Antibody Small Molecule	TLX591 TLX591-Cdx (PSMA-11) Therapy TLX591				Imaging
Brain	131I 124I	LAT-1 LAT-1	Small Molecule Small Molecule	TLX101-Cdx – Research Use Only Therapy Imaging TLX101
						Shaded arrows indicate the company’s development
						objectives out to approximately end-2019
								4

TLX250 Program (Renal Cancer)

: Imaging (TLX250-CDx :[89] Zr-DFO-Girentuximab)

• Bridging / dosimetry study ( ZIR-DOSE )

• ✓ 8/10 patients recruited, expect completion before year-end

• ✓ Interim analysis : 25% lower radiation to the patient with[89] Zr c/f[124] I

• Phase III study ( ZIRCON )

• ✓ Early go-ahead from the TGA, first Australian site (1/4) ethics complete

• ✓ EU submissions ongoing – key review dates in November

• First consultation with the Japanese PMDA - beneficial guidance toward commencement of clinical activity in Japan in early 2019

Therapy (TLX250 :[177] Lu-DOTA-Girentuximab) :

• GMP manufacturing of clinical material nearly completed.

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• ✓ Expect to release filled/finished materials by end-November

• ✓ IND / protocol development in progress for checkpoint combo studies in clear cell renal cell cancer (ccRCC) at key US and Australian sites

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TLX591 Program (Prostate Cancer)

Imaging (TLX591-CDx :[68] Ga-HBED-PSMA-11) – illumet[TM] Kit[*]

• Multiple clinical trials now referencing the kit FDA drug master file (DMF)

• Endocyte, MSKCC recruiting. MSKCC imaging several patients per week

• Positive user feedback, nicely growing pipeline of sales leads

• Distribution agreement with Cardinal Health (+ other pharmacy networks in progress) to support commercialization activity in the US

: Therapy ([177] Lu-DOTA-TLX591)

• Following the acquisition of Atlab, we have almost completed the data analysis for[177] Lu-huJ591, including fractionated dose cohorts

• Telix will shortly publish a summary of the data

• Active partnering discussions post-acquisition of Endocyte by Novartis, reflective of the demand for PSMA therapeutic assets

• Manufacturing of both huJ591 and TLX591 (Pk-modified huJ591) monoclonal antibodies progressing well to enable clinical trials in 2019

(Kit for the preparation of[68] Ga-HBED-CC-PSMA11)

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Telix is now producing the illumet[TM] “shake and shoot” kit at commercial scale in the US, reflective of the demand for prostate cancer imaging

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*Investigational use only

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TLX101 Program (Glioblastoma)
Therapy ( [131] I-TLX101)
•
IPAX-1 study (Phase I/II):
✓ A total of 7 sites – EU and Australia – now finalized for the study
✓ Allowance from the Austrian health authorities (Bundesamt für
Sicherheit im Gesundheitswesen or BASG) to commence the study
✓ Linz/Vienna sites are the lead sites, with a 3 [rd] Austrian site to follow
(subject to ethics approval)
✓ Regulatory/ethics documentation in progress for 4 additional sites in
Netherlands and Belgium
✓ Australian TGA submission by end-November to be able to include
Australian patients into the study (via a clinical partnership with
GenesisCare)
✓ Strong clinical interest in the study from participating sites
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Manufacturing and Distribution Network : Established

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✓ Key partners are in place
✓ For clinical trials and
early commercial
product roll-out
✓ Discussion ongoing
with partners for Backup
MENA, Asia
and LATAM
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	Catalysts Date Activity Mid-Nov Summary of prostate cancer therapeutic data (huJ591) and roadmap for 2019 prostate cancer trials TLX250 therapy collaboration update End-Nov Update on EU approvals for ZIRCON study Update on patient recruitment for ZIRCON and IPAX-1 studies Completion of TLX250 therapy manufacturing (6 week delay) Mid-Dec Completion of ZIR-DOSE bridging / dosimetry study illumetTM – product launch / sales progress update (US market) 9
	Date	Activity
	Mid-Nov	Summary of prostate cancer therapeutic data (huJ591) and roadmap for 2019 prostate cancer trials
		TLX250 therapy collaboration update
	End-Nov	Update on EU approvals for ZIRCON study
		Update on patient recruitment for ZIRCON and IPAX-1 studies
		Completion of TLX250 therapy manufacturing (6 week delay)
	Mid-Dec	Completion of ZIR-DOSE bridging / dosimetry study
		illumetTM – product launch / sales progress update (US market)