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Telix Pharmaceuticals Ltd Investor Presentation 2018

Sep 10, 2018

31324_rns_2018-09-10_749c0362-95c2-4f34-97c5-4367d4c3242d.pdf

Investor Presentation

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Market Briefing

Atlab Pharma SAS Acquisition

11 September , 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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Atlab Transaction Summary

  • USD $9m in Telix shares to Atlab shareholders at $0.89 per share (10 day VWAP prior to signing)

  • ➢ Management shares (41%) escrowed for 2 years. The remaining investor shares are subject to 25% escrow for 3 months and 75% for 1 year

  • ➢ Reduced consideration for Atlab reflects diverted consideration to a key licensor (BZL) for reduced royalties and assumption of responsibility for a repayable R&D loan facility of €258,000

  • USD $500,000 in Telix shares to BZL at $0.89 per share. Escrowed for 2 years

  • USD $500,000 in warrants over Telix shares to BZL, with an exercise price of

  • ➢ $1.34 per share (calculated as 150% of the 10-day VWAP prior to signing). The warrants vest in 2 tranches on the first and second anniversary of the issue date and will expire if not exercised within four years of grant

The total number of new shares issued is 14.84 million shares representing a dilution of 7%. The shares are issued to 21 new shareholders. No allotted holder is a substantial holder under the Corporations Act

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Atlab Pharma & BZL Biologics : Background

Atlab Pharma SAS

  • Spin-out from Centre Hospitalier Universitaire (CHU) de Nantes, founded in 2008

BZL Biologics, LLC

  • Led by Prof. Neil Bander, a global thought leader in PSMA drugs

  • In-licensed the radioactive rights to huJ591 (anti-PSMA antibody) from BZL Biologics

  • Based on technology developed at Weill Cornell Medical Center (WCMC) in NYC

  • Phase II investigator-initiated trials underway in the US and France –focused on the use of PSMA-targeted[177] Lu and[211] At radionuclides

  • IP portfolio of biological resources and clinical data related to the huJ591 anti-PSMA monoclonal antibody – licensed to Atlab

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Strategic Rationale for Transaction

  • Access to intellectual property rights that may protect certain future applications of TLX591

  • ➢ Image-based selection of patients for therapy

  • ➢ Combination use with androgen drugs

  • Important clinical data relating to the antibody that TLX591 was derived from → informs development of TLX591

  • Manufacturing-related knowledge and reference materials that are relevant to the development of TLX591

  • Research platform that can be made accessible to academia to drive further clinical interest in antibody-based PSMA-targeted radiation

  • Invaluable key opinion leader (KOL) engagement

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What is PSMA?

  • PSMA stands for P rostate- S pecific M embrane A ntigen and is a cell surface protein that is ubiquitously expressed by prostate cancer cells, including metastases

  • TLX591 is a prostate cancer therapeutic that is derived from the most clinically-studied PSMA-targeting monoclonal antibody (mAb) in the world : huJ591 (BZL/Cornell)

  • PSMA has some normal tissue expression (gastric, kidney, exocrine glands, including salivary and lacrimal glands) but an antibody targeting PSMA can’t reach “normal” PSMA

  • Small molecules targeting PSMA are able to penetrate “tight junctions” to reach normal tissue expression of PSMA

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P rostate
S pecific
M embrane
A ntigen
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Antibodies are functionally specific to cancer-expressed PSMA and small molecules are not[1]

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1) Holland et al. J Nucl Med. 2010 August ; 51(8): 1293–1300

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Salivary and
D
lacrimal gland
uptake is
Telix/ANMI Kit Images PSMA – TLX591 Treats It
normal
A B C
It is possible to image disease with
PSMA-11, even at very low PSA
High
levels (= low tumour burden) Slight liver kidney
uptake
uptake
The three panels A)-C) illustrate
EVERYWHERE
how PSMA imaging avidity
changes as a function of PSA
levels (from low to high PSA). All of
these patients are imaged post-
prostatectomy [1] Cancer
A few highly vivid tumours are
marked for noting (red arrows)
Bladder
(excreted
Tumour load Low Medium High tracer/urine)
PSA 4.8ng/ml 454ng/ml 2860ng/ml
D) A typical PSMA-11 projection image
illustrating the biodistribution of the tracer [2]
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1) Adapted from : Oncotarget . 2017; 8:55094-55103
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  • 1) Adapted from : Oncotarget . 2017; 8:55094-55103 2) Image from : J Nucl Med J anuary 1, 2017 vol. 58 no. 1 81-84, teaching resource

huJ591 TLX591

TLX591 : the “Next Generation” PSMA Therapy

  • huJ591 is an antibody that pioneered PSMA therapeutics but has some shortcomings that are addressed by TLX591

  • TLX591 is an engineered variant of huJ591 that:

  • ✓ limits blood/bone marrow toxicity by clearing faster from the body ✓ delivers the same level of radiation to the tumour with a superior

  • serum half-life of 12 hours instead of 133 hours

  • ✓ is a significantly more stable antibody with much higher production efficiency, lower manufacturing costs

New Telix-owned IP combined with IP from Abzena PLC and Atlab/BZL delivers long-term protection and broad coverage

Prostate tumour transplanted into a specialized transgenic mouse model demonstrates 10x faster blood clearance

Tumour Tumour 133 133 Hours 12 Hours Post-injection Post-injection

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Antibodies vs. Small Molecules

  • Several companies are investigating small molecule PSMA therapeutics (radiopharmaceuticals)

  • Early stage : AAA (Novartis), Blue Earth Diagnostics

  • Late stage (Ph III): Endocyte (NASDAQ: ECYT)

  • Major limitations of small molecules:

  • Off-target effects such as exocrine gland uptake that may limit attractiveness in earlier-stage (healthier) patients

  • Muddy IP landscape

A PET scan illustrating the typical biodistribution of PSMA small molecules (i.e. PSMA 617/11), highlighting exocrine gland uptake. This is a serious matter that may ultimately limit the delivery of optimized therapy

  • Nephrotoxicity (kidney toxicity) risk when used to deliver high-dose[177] Lu or alpha-emitting radionuclides

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Antibody-Based Approach Delivers Superior Efficacy

Overall Survival PSMA-Antibody 2x 45mCi PSMA-617* (Endocyte) (P=0.011)

Cross-trial comparison between[177] Lu-PSMA-617 and[177] Lu-huJ591

Median overall survival (OS) is >40 months (hu591) vs 15 months (PSMA-617 )

Unpublished data. Analysis performed by ABX CRO. Preliminary data suggests that further clinical development of the antibody-based approach is competitively viable

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*Data from the German multi-center trial for PSMA-617 : Rahbar et al. (JNM 2017)

The Atlab Acquisition Enables Better Clinical Strategies

The Atlab/BZL team have established an important clinical data set around the optimal dosing of antibodybased PSMA therapeutics

The conventional wisdom is that the long circulation time of antibodies results in unacceptable hematologic toxicity

The data demonstrates that low dose “repeat dosing” schemes or “fractionation” results in a highly tolerable and effective treatment regimen.

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TLX591 as a Potential Combination Therapy

  • Prostate Cancer is driven by androgen (testosterone) levels

Induce androgen deprivation for a short time Before After (short-term hormone use)

  • Standard of care (SOC) is to use drugs that block androgen, slowing disease progression

  • ➢ Androgen deprivation therapy (ADT) has a serious side-effect profile including metabolic consequences and impacted sexual function

  • ➢ Blockbuster androgen drugs include Xtandi® (Enzalutamide)[1] and Zytiga® (Abiraterone)[2]

Drive PSMA expression

Target cancer that has been androgensensitized to PSMA therapy

  • ➢ Androgen controls PSMA expression and is therapeutically synergistic

Potential to transform standard of care

Pause hormone therapy

$6 billion market potential[3]

  1. Astellas/Pfizer

  2. Janssen (J&J)

  3. Astellas, Johnson and Johnson and Bayer Annual Reports (2016/17)

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Expansion of the TLX591 Market Opportunity

End-of-life or “salvage” therapy

Combination therapy

  • Limited market

  • Benchmark : Bayer Xofigo®.

  • ~16,000 patients annually treated in the US / EU (estimated)

  • 4 years post-approval – roughly at “peak” sales (USD 500m)

  • Price point is between $40,000 and $60,000 (country-dependent)

  • Earlier patient population, larger size

  • Combination of ADT and TLX591

  • 60,000+ patients / year in the US alone

  • Treatment budget is greater

  • Potential to offer patients a “treatment holiday” from hormone therapy

The Atlab transaction enables Telix to move from a salvage therapy indication to earlier stage patients, significantly increasing the value of TLX591

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Summary

The acquisition of Atlab and the BZL/Cornell background IP augments the potential reach and impact of TLX591

  • ✓ Further positions TLX591 as a serious contender in the treatment of prostate cancer, backed by over a decade of clinical data

  • ✓ Builds on the experience and proven superiority of the antibody-based PSMA therapy approach

  • ✓ Positions Telix as the only serious antibody-based contender in a competitive landscape for PSMA radiopharmaceuticals that is dominated by small molecule approaches

  • ✓ Supports the potential deployment of TLX591 in earlier-stage patients – significantly increasing the value of the program

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www.telixpharma.com

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