asx:tlx - jefferies...metastatic prostate cancer : diagnostic (pre- nda), therapeutic (ph iii) renal...

28
ASX:TLX Jefferies Healthcare Conference New York 4 th June 2019

Upload: others

Post on 14-Aug-2020

0 views

Category:

Documents


0 download

TRANSCRIPT

Page 1: ASX:TLX - Jefferies...Metastatic prostate cancer : Diagnostic (pre- NDA), Therapeutic (Ph III) Renal (kidney) cell cancer : Diagnostic (Ph III), Therapeutic (Ph II) Brain cancer (glioblastoma)

ASX:TLX

Jefferies Healthcare ConferenceNew York4th June 2019

Page 2: ASX:TLX - Jefferies...Metastatic prostate cancer : Diagnostic (pre- NDA), Therapeutic (Ph III) Renal (kidney) cell cancer : Diagnostic (Ph III), Therapeutic (Ph II) Brain cancer (glioblastoma)

Notices

The information contained in the presentation is not intended to be an offer for subscription, invitation or recommendation with respect toshares of Telix Pharmaceuticals Limited (“Telix”) in any jurisdiction, including the United States. No representation or warranty, express orimplied, is made in relation to the accuracy or completeness of the information contained in this document or opinions expressed in thecourse 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 inthis presentation are subject to significant risks, uncertainties, assumptions, contingencies and other factors (many of which are outside thecontrol of, and unknown to Telix, and its officers, employees, agents or associates), which may cause the actual results or performance tobe 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 resultspertaining to clinical subjects used in this presentation are illustrative of medical conditions and outcomes associated with potentialapplications of Telix’s product pipeline. Actual results from clinical trials may vary from those shown. None of the products or potentialproducts described in this presentation have received a marketing authorization in any jurisdiction.

2

Page 3: ASX:TLX - Jefferies...Metastatic prostate cancer : Diagnostic (pre- NDA), Therapeutic (Ph III) Renal (kidney) cell cancer : Diagnostic (Ph III), Therapeutic (Ph II) Brain cancer (glioblastoma)

Company Snapshot

• Founded in 2015 by Dr. Chris Behrenbruch and Dr. Andreas Kluge, experienced nuclear medicine executives

• Board : Kevin McCann (ex-Chairman, Macquarie Bank), Mark Nelson (Caledonia), Jann Skinner (ex-PwC Partner) and Oliver Buck (ITM Group)

• Melbourne (Australia) HQ with operations in USA, Europe and Japan

Telix develops diagnostic and therapeutic radiopharmaceuticals for:Metastatic prostate cancer : Diagnostic (pre-NDA), Therapeutic (Ph III)Renal (kidney) cell cancer : Diagnostic (Ph III), Therapeutic (Ph II)Brain cancer (glioblastoma) : Therapeutic (Ph I/II)

Multiple commercial partnerships with leading global healthcare companies

3

Melbourne

Kyoto

Liege

Indianapolis

Page 4: ASX:TLX - Jefferies...Metastatic prostate cancer : Diagnostic (pre- NDA), Therapeutic (Ph III) Renal (kidney) cell cancer : Diagnostic (Ph III), Therapeutic (Ph II) Brain cancer (glioblastoma)

• Nov 2017 – $50m IPO on the Australian Securities Exchange (ASX). Raised AUD $50m• Predominantly an institutional shareholder base : Fidelity, Acorn Capital, UV Cap• Balance sheet : AUD ~$25m, AUD (inclusive of $9m R&D tax refund this quarter)• Early revenue generation from prostate cancer imaging product• Runway to mid-2020

$1.06(31 May 2019)

Mkt. Cap: ~A$230m(USD $160m)

Disease Focus Oncology

Clinical Stage Phase I - III

Shares on Issue 218.4m

Options on Issue 11.1m

Cash on Hand ~AUD $25m

ASX Ticker TLX

Financial Snapshot

IPO Price: $0.65

4

(YTD)

Page 5: ASX:TLX - Jefferies...Metastatic prostate cancer : Diagnostic (pre- NDA), Therapeutic (Ph III) Renal (kidney) cell cancer : Diagnostic (Ph III), Therapeutic (Ph II) Brain cancer (glioblastoma)

Our Approach : Molecularly-Targeted Radiation (MTR)MTR works by chemically“linking” radioactive isotopesto targeting molecules thatare very specific for cancercells. At low doses, thisenables the location of thecancer cells to be pinpointedusing PET imaging. At highdoses the patient is veryeffectively treated

We distinguish the term MTRbecause there are many“radiopharmaceuticals” thatare not targeted. Telix istargeting agent agnostic – weuse both antibody and small-molecule approaches

5

Page 6: ASX:TLX - Jefferies...Metastatic prostate cancer : Diagnostic (pre- NDA), Therapeutic (Ph III) Renal (kidney) cell cancer : Diagnostic (Ph III), Therapeutic (Ph II) Brain cancer (glioblastoma)

• Telix develops drugs that deliver targeted radiation directly to cancer. At low radiation dose (or using diagnostic nuclides), the patient can be imaged

At higher radiation doses (with therapeutic nuclides) the patient is treated

See it, Treat it…

TLX591-CDx (Prostate)1 TLX250-CDx (Kidney)2 TLX101 (Brain)3

Positron Emission Tomography – “PET”

The use of molecular imaging with PET enables a precision medicine

approach to treatment through

better patient selection and

personalized dose optimization

61 Courtesy of Dubai Nuclear Medicine & Molecular Imaging Center, UAE 2 Courtesy of Radboud University Medical Centre, Netherlands3 Courtesy of ZentralKlinik Bad Berka, Germany

Page 7: ASX:TLX - Jefferies...Metastatic prostate cancer : Diagnostic (pre- NDA), Therapeutic (Ph III) Renal (kidney) cell cancer : Diagnostic (Ph III), Therapeutic (Ph II) Brain cancer (glioblastoma)

Why is MTR so therapeutically effective?CONVENTIONAL TARGETEDNon-Radioactive Drugs

MOLECULARLY TARGETED RADIATIONMTR Therapy

7

Page 8: ASX:TLX - Jefferies...Metastatic prostate cancer : Diagnostic (pre- NDA), Therapeutic (Ph III) Renal (kidney) cell cancer : Diagnostic (Ph III), Therapeutic (Ph II) Brain cancer (glioblastoma)

Clinical PipelineR

enal

Pros

tate

GBM

Phase I Phase II Phase III Commercial

TLX250 (Girentuximab)

TLX591

TLX591-Cdx (PSMA-11)

TLX101-Cdx – Research Use Only

TLX250-Cdx (Girentuximab)

177Lu CA-IX Antibody

Isotope Target Agent

89Zr CA-IX Antibody

177Lu PSMA Antibody

68Ga PSMA Small Molecule

131I LAT-1 Small Molecule

124I LAT-1 Small Molecule

Therapy

Imaging

Therapy

Imaging

Therapy

Imaging

Shaded arrows indicate the company’s development objectives over the next 18 monthsCDx denotes “Companion Diagnostic”

TLX591

TLX591-Cdx (PSMA-11)

TLX101

8

Page 9: ASX:TLX - Jefferies...Metastatic prostate cancer : Diagnostic (pre- NDA), Therapeutic (Ph III) Renal (kidney) cell cancer : Diagnostic (Ph III), Therapeutic (Ph II) Brain cancer (glioblastoma)

Telix’s Pipeline is a Multi-$Bn Opportunity *

TLX591: Metastatic prostate cancer radionuclide therapy is $2Bn opportunity in late-stagedisease alone

TLX591–CDx: Prostate cancerimaging (targeting PSMA) is the biggest

new indication for PET/CT in radiology and represents a $500m opportunity in the US alone.

Detecting early metastatic disease is a major unmet need

TLX101: The treatment of GBM isa $300m market opportunity withfew beneficial options for patients

TLX250-CDx: Renal cancer patients are often mis-staged, a niche $250m opportunity with no real competition

* Company estimates, in US dollars annually

TLX250: Our therapy for patients thathave progressed from immunotherapy is a $400-500m opportunity

9

Page 10: ASX:TLX - Jefferies...Metastatic prostate cancer : Diagnostic (pre- NDA), Therapeutic (Ph III) Renal (kidney) cell cancer : Diagnostic (Ph III), Therapeutic (Ph II) Brain cancer (glioblastoma)

TLX591-CDx (PCa Imaging)

Proprietary formulation of the most popular PSMA imaging agent – and a “cold kit” prep

Room temperature radiolabelling in minutes Sterile kit, “dose on demand” Sold in the US and EU for

investigational and“magisterial” use

NDA Filing Preparation in Progress

Pre-NDA meeting request submitted to the FDA 505(b)(2) pathway based on FDA guidance, use

of EU data Telix has data in ~1,000 EU patients to support

regulatory filings in the US Concurrent discussions in progress with several

EU authorities for product approval

68Ga-HBED-CC-PSMA11

Prostate-Specific Membrane Antigen (PSMA)

1,000ds of patients

Commercial

PSMA11 is the most widely used PSMA prostate cancer agent

In over 150 publications, PSMA11 has demonstrated excellent detection of prostate cancer from high-risk pre-prostatectomy patients to BCR and metastatic disease

Already in the EAU guidelines for prostate cancer management

10

Page 11: ASX:TLX - Jefferies...Metastatic prostate cancer : Diagnostic (pre- NDA), Therapeutic (Ph III) Renal (kidney) cell cancer : Diagnostic (Ph III), Therapeutic (Ph II) Brain cancer (glioblastoma)

Early TLX591-CDx Adoption is Growing Fast

8

1

38 1

5

3

71

5

5

12

Australia: 1UAE: 1

1

49

>100 sites around the world use the product routinely or in clinical trials

Mostly large cancer centres that are capable of doing 10-15 pts a week (upon product approval)

Sales on track to deliver between 10,000 and 15,000 doses in 2019 (globally)

Average reimbursed price-point (post-approval) of USD ~$3,500 / €2,200

*68Ga-PSMA-11 is an investigational product andhas not received marketing authorization in any jurisdiction 11

Page 12: ASX:TLX - Jefferies...Metastatic prostate cancer : Diagnostic (pre- NDA), Therapeutic (Ph III) Renal (kidney) cell cancer : Diagnostic (Ph III), Therapeutic (Ph II) Brain cancer (glioblastoma)

TLX591 (PCa Therapy)

Antibody-based approach to targeting PSMA Superior survival compared with small molecule

PSMA approaches* Functionally-specific for tumour-expressed

PSMA No-off target exocrine/renal toxicity Clear IP position (unlike Progenics/Novartis)

PROSTACT Phase III Trial (planned) ADT progressive patients. ~550 patients Run-in study : 72 patients to optimise

fractionation interval / immune response TLX591+SC vs SC Start Q3 2019 in Australia (run-in), US Q4

2019/Q1 2020** following FDA rev of Ph III design Capital needs for Ph III expected to be met

through partnering (active discussions)* Based on a retrospective cross-trial comparison** Subject to regulatory approval

177Lu-DOTA-huJ591

Prostate-Specific Membrane Antigen (PSMA)

6 Ph I/II trials>200 patients

Phase III

Retrospective cross-trial comparison between 177Lu-PSMA-617 and 177Lu-huJ591 (TLX591)

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

12

Page 13: ASX:TLX - Jefferies...Metastatic prostate cancer : Diagnostic (pre- NDA), Therapeutic (Ph III) Renal (kidney) cell cancer : Diagnostic (Ph III), Therapeutic (Ph II) Brain cancer (glioblastoma)

Fractionation Addresses Hematologic Toxicity

Traditionally, antibody (mAb)-directed radiotherapies were considered to have an unacceptable hematologic toxicity profile because of the long circulation timeHowever, fractionated dosing – as is done with small molecules (i.e. PSMA-617) –leads to highly tolerable toxicity profile with likely superior efficacy

13

Single dose70 mCi/m2

* Note: Cohort rendering excludes a limited number of patients that did not receive a second dose

Page 14: ASX:TLX - Jefferies...Metastatic prostate cancer : Diagnostic (pre- NDA), Therapeutic (Ph III) Renal (kidney) cell cancer : Diagnostic (Ph III), Therapeutic (Ph II) Brain cancer (glioblastoma)

14

Objective PSA Response*

14

PSA waterfall plot showing each patient’s best PSA response. Patients treated with lower doses of 177Lu-J591(20-35 mCi/m2 ×2) are indicated in light gray; patients who received recommend phase 2 doses are indicated in blue (40 mCi/m2 ×2) or red (45 mCi/m2 ×2).

Time in months from treatment

40 mCi/m2 ×2

45 mCi/m2 ×2

*Tagawa et al. Cancer March 2019

Page 15: ASX:TLX - Jefferies...Metastatic prostate cancer : Diagnostic (pre- NDA), Therapeutic (Ph III) Renal (kidney) cell cancer : Diagnostic (Ph III), Therapeutic (Ph II) Brain cancer (glioblastoma)

15

PSMA-617(Novartis)

TLX591(Telix)

Lacrimal, Parotid,Submandibular (salivary) glands

Spleen, Liver

Kidneys, Small bowel

Bladder (urinary excretion)

Liver (preferred clearance

organ)

Large bowel(fecal excretion)

Off-Target Irradiation – Quality of Life Matters

Small molecule-based approaches such as PSMA-617 (Endocyte / Novartis) are able to hit endogenous PSMA expression whereas antibodies are only functionally-specific for tumor-expressed PSMA.

This means that TLX591 does not cause additional unpleasant side-effects like dry eye and salivary gland dysfunction

Data courtesy of Prof. Neil Bander, WCMC15

Page 16: ASX:TLX - Jefferies...Metastatic prostate cancer : Diagnostic (pre- NDA), Therapeutic (Ph III) Renal (kidney) cell cancer : Diagnostic (Ph III), Therapeutic (Ph II) Brain cancer (glioblastoma)

TLX250-CDx (Renal Ca Imaging)

252 patient global phase III study, recruiting Imaging of ccRCC in pre-surgical patients 25 sites US/Europe/Australia/Canada Trial approved and recruiting in AU/FR/NL FDA Pre-IND meeting preparation in progress Primary end-point : sensitivity/specificity for clear

cell RCC vs histology (from surgical resection)

89Zr-DFO-girentuximab

Carbonic Anhydrase IX(CAIX)

>300 patientsimaged with124I, 89Zr

Phase III(Confirmatory)

Benign

MalignantccRCC

Prior Ph III trialwith 124I

ZIRDOSE 124I to 89Zr bridging study complete

89Zr = superior image quality, clinical utility, economics

NCT03849118

16

Page 17: ASX:TLX - Jefferies...Metastatic prostate cancer : Diagnostic (pre- NDA), Therapeutic (Ph III) Renal (kidney) cell cancer : Diagnostic (Ph III), Therapeutic (Ph II) Brain cancer (glioblastoma)

TLX250 (Renal Ca Therapy)

Two combination I-O therapy studies planned for mid-2019 (total 60 patients – PoC)

STARLITE1 – combination TLX250 + SC (pembrolizumab + axitinib) in first-line ccRCC

STARLITE2 – cycled TLX250, nivolumab in patients that have progressed on I-O therapy

Endpoints : safety/tolerability, efficacy via imaging (tumour reduction and immune cell)

177Lu-DOTA-girentuximab

Carbonic Anhydrase IX(CAIX)

37 patients with 177Lu Phase II

STARLITE (Pending) >10 months PFS in heavily pre-treated metastatic ccRCC patients with no other treatment options

Well tolerated, amenable to repeat dosing Best responders were patients that received

repeat low-dose treatment – suggestive of an immune-driven treatment response

Average tumor increase (RECIST) in the 3 months prior to treatment was 40.4%

In the 3 months after treatment it was 5.5%

17

Page 18: ASX:TLX - Jefferies...Metastatic prostate cancer : Diagnostic (pre- NDA), Therapeutic (Ph III) Renal (kidney) cell cancer : Diagnostic (Ph III), Therapeutic (Ph II) Brain cancer (glioblastoma)

TLX101 (Glioblastoma Therapy)

44 patient Ph I/II study. 8 EU/AU sites Recurrent GBM, recruiting In combination with XRT (IPAX = IPA + XRT) Safety/efficacy with a run-in study to formally

conduct dose optimisation Conducted in EU/AU to specifically study

bevacizumab-naïve patients

*Subject to regulator agreement

131I-IPALAT-1(Large Amino Acid Transporter)

11 rGBMpatients under SAS

Phase I/II(Confirmatory)

NCT03849105

F/U month 4Baseline

Baseline F/U month 10

Image-based evaluations with MRI and PET are invaluable for measuring treatment response in GBM patients

Case Study:• Treatment: 2GBq TLX101 single dose I.V.• Safety: no acute, sub-acute or delayed

toxicity• Efficacy: Continuous tumor regression

over 10 months. Patient remained professionally active for 24 months

• Survived >40 months (with further therapy)

Studied under compassionate use in Germany

Triple mechanism of action Several responders, 2 CRs Orphan designation in the

US / EU

18

Page 19: ASX:TLX - Jefferies...Metastatic prostate cancer : Diagnostic (pre- NDA), Therapeutic (Ph III) Renal (kidney) cell cancer : Diagnostic (Ph III), Therapeutic (Ph II) Brain cancer (glioblastoma)

Multiple Milestones and Readouts in 2019Q1 Q2 Q3 Q4

TLX591

Imaging (Phase III)

Therapy(Phase I/II)

Imaging

Therapy(Phase III)

Therapy(Phase I/II)

NDA1 (US)

US/JP2 IND Filed Enrolment Complete

US IND Filed FPI Update Interim Results

Info Package to FDA Pre-NDA meeting NDA Go/No Go

Info Package to FDA Pre-IND meeting Phase III Go/No Go First Patient In

Interim Results

Ren

al

Can

cer

Pros

tate

C

ance

rG

BM

Recruitment updateRegulatory milestoneClinical trial milestone

191 New Drug Application, subject to regulatory approval2 Japanese CTN is Phase I/III “bridging study”

Mfg completed

Page 20: ASX:TLX - Jefferies...Metastatic prostate cancer : Diagnostic (pre- NDA), Therapeutic (Ph III) Renal (kidney) cell cancer : Diagnostic (Ph III), Therapeutic (Ph II) Brain cancer (glioblastoma)

Key partners in place

For clinical trials andearly commercialproduct roll-out

Discussion ongoingwith partners for MENA, Asia and LATAM Backup

Extensive Supply Chain and Production Network Established

20

Page 21: ASX:TLX - Jefferies...Metastatic prostate cancer : Diagnostic (pre- NDA), Therapeutic (Ph III) Renal (kidney) cell cancer : Diagnostic (Ph III), Therapeutic (Ph II) Brain cancer (glioblastoma)

Competitive Landscape

Very few companies in the radiopharmaceutical / MTR space with a late-stage product pipeline. Telix is a unique company

Moderate competition in prostate and GBM, zero meaningful competition in renal cancer for our drug class

Novartis (Endocyte / AAA) : have a Phase III prostate cancer program. “Co-opetition” – Telix provides PSMA imaging for VISION trial

Progenics : has both prostate imaging and therapy programs. Product profile for prostate therapy program is difficult due to use of 131I. Currently suing Novartis for IP infringement

Bayer : antibody-based PSMA thorium conjugates. Nice data but clinically challenging to use and recent Xofigo® counter-indication for combo ADT may be a significant problem because 223Ra is a daughter decay product of 227Th

Janssen : active, early stage (Phase I) prostate program with 225Ac Theragnostics : early-stage company, has tried to develop a “room

temperature” prostate kit for 68Ga-PSMA. Clinical data is difficult to interpret

21

Page 22: ASX:TLX - Jefferies...Metastatic prostate cancer : Diagnostic (pre- NDA), Therapeutic (Ph III) Renal (kidney) cell cancer : Diagnostic (Ph III), Therapeutic (Ph II) Brain cancer (glioblastoma)

Valuation Benchmarks : Plenty of Sector Activity

22

Competing PhIII prostate program

Sold to Novartis in Dec 2018 for USD $2.1Bn (AUD $2.9Bn)

Limited pipeline, most of the valuation based on a single orphan program (Lutathera®)

Sold to Novartis in Jan 2018 for USD $3.9Bn (AUD $5.5Bn)

NASDAQ: PGNX Market cap USD $390m

(AUD $550m)

Privately held UK company, majority held by Syncona LIC.

Est market cap of ~£200m (AUD $370m)

Telix is successfully displacing BE’s products

Sold to CDH in June 2018 for AUD $1.9Bn

CDH bid usurped Varian Medical Systems

NO: NANO, limited mid-stage pipeline

Market cap NOK 2.53Bn (AUD $415m)

Page 23: ASX:TLX - Jefferies...Metastatic prostate cancer : Diagnostic (pre- NDA), Therapeutic (Ph III) Renal (kidney) cell cancer : Diagnostic (Ph III), Therapeutic (Ph II) Brain cancer (glioblastoma)

Management TeamDr. Christian Behrenbruch (Co-Founder, MD and CEO)Chris has 20 years of healthcare executive experience as CEO, Mirada Solutions, CTIMolecular Imaging (now Siemens Healthcare), Fibron Technologies and ImaginAb, Inc.,former Director of Momentum Biosciences LLC, Siemens Molecular Imaging Ltd, RadiusHealth Ltd (now Adaptix) and was the former Chairman of Cell Therapies P/L.. He iscurrently a non-executive director of Factor Therapeutics (ASX:FTT). Christian holds aD.Phil (PhD) in biomedical engineering from the University of Oxford, an executive MBA(TRIUM Program) and a Juris Doctor (Law) from the University of Melbourne.

Dr. Andreas Kluge (Co-Founder and Chief Medical Advisor)Andreas has 20 years of clinical research and development experience, including asFounder, General Manager and Medical Director for ABX-CRO GmbH, a full serviceCRO based in Dresden, Germany. Andreas is a physician and holds a doctorate inMedicine from the Free University of Berlin.

Mr. Douglas Cubbin (CFO)Doug has spent the last eleven years in CFO, COO, commercial and businessdevelopment roles in companies in the nuclear medicine sector. Prior to that Doug, wasthe Group CFO of DHL (Australia-Pacific). From 2013 to 2016, Doug was the Chairmanof Australian Nuclear Science and Technology Organisation (ANSTO) and the GeneralManager of Business Development at ANSTO. Doug is a fellow of the Australian Societyof CPAs and a Graduate of the Institute of Company Directors

Dr. Michael Wheatcroft (Director of R&D)After completing a PhD in the Department of Biochemistry, Cambridge University,Mike worked at Cambridge Antibody Technology (now Medimmune). After movingto Melbourne in 2010, Mike oversaw the pre-clinical development of severalengineered antibody drug conjugates at AviPep P/L. Mike has worked in seniordevelopment roles at Medicines Development Limited, Hatchtech Pty Ltd andStarpharma Limited

Dr. Marissa Lim (Director of Global Medical Affairs)Marisa has held a number of senior and international medical director positions atIpsen, Vifor and Hospira, BMS and Novartis, before joining Telix. She bringsextensive experience in oncology trial design and management, particularly indisease focus areas relevant to Telix. Marissa obtained her medical degree fromMonash University.

Ms. Alannah Evans (Director of Quality/Regulatory)Alannah has 20 years of experience in quality-controlled manufacturing andbiological material processing. Prior experience included technical and managerialroles at Nucleus Network, Cell Therapies P/L (Peter MacCallum Cancer Centre),Eastern Health and Gribbles Pathology. Alannah has a bachelor’s degree inbiomedical sciences from Curtain University and master’s degree in biotechnologyand business from RMIT.

Dr. Jyoti Arora (Director of Manufacturing Operations)Jyoti has extensive experience in project management, operations and GMPmanufacturing. Prior to joining Telix, Jyoti was a Senior Project Manager at CellTherapies Pty Ltd, with responsibility for overseeing product development ofseveral advanced cell and gene therapy technologies. She holds a PhD in MedicalScience and Radiopharmaceutical Chemistry from RMIT University

Dr. Gabriel Liberatore (COO)Gabriel has twenty years’ experience in senior BD and R&D roles including with CSLLimited (ASX:CSL), Deloitte (Australia), Swisse Wellness (HK:112) and the PACT Group(ASX:PGH). Gabriel holds a PhD in Neuroscience from the University of Melbourne, apost-doctorate from Columbia University and an MBA from La Trobe. He is an AdvisoryBoard member at Swinburne University.

23

Page 24: ASX:TLX - Jefferies...Metastatic prostate cancer : Diagnostic (pre- NDA), Therapeutic (Ph III) Renal (kidney) cell cancer : Diagnostic (Ph III), Therapeutic (Ph II) Brain cancer (glioblastoma)

Board of Directors

Mr. Oliver BuckNon-executive DirectorOliver is Founder of ITM Group, one of the largest isotope manufacturing and distributioncompanies in the world. He is an experienced executive and business developer inmedical and defence industries. Oliver holds a masters degree in theoretical physics fromthe Technical University of Munich.

Dr. Mark NelsonNon-executive DirectorMark is the Chairman and Co-founder of The Caledonia InvestmentsGroup, a global investment management firm based in Sydney. He isVice President of the Board of Trustees of the Art Gallery of NSWand serves on the Board of a number of other not for profitenterprises including the Florey Neurosciences Institute. Mark holdsa M.Phil in bioscience ]from the University of Cambridge and a Ph.Din molecular biology from the University of Melbourne.

Mr. H. Kevin McCann AMChairmanKevin is currently Chairman of Citadel Group and former Chairmanof Dixon Hospitality, Macquarie Bank Limited, Origin Energy,Healthscope Limited and ING Management Limited. Kevin practicedas a Commercial Lawyer as a Partner of Allens Arthur Robinsonfrom 1970 to 2004 and was Chairman of Partners from 1995 to2004. Kevin has a Bachelor of Arts and Law (Honours) from SydneyUniversity and a Master of Law from Harvard University.

Dr. Christian BehrenbruchDr. Andreas KlugeExecutive Directors (see next slide)

Ms. Melanie FarrisCompany SecretaryMelanie is an experienced governance, communications and operations executive.Currently a non-executive director for Synapse Australia Limited, and in governance andoperations roles with Factor Therapeutics Limited (ASX:FTT) and Invion Limited(ASX:IVX), previous roles include with HRH The Prince of Wales’s Office, Global AssetManagement, Imperial Cancer Research Fund, and The Prince’s Foundation. Melanieholds a Bachelor of Communication (Public Relations), and a Graduate Diploma inApplied Corporate Governance. She is an Associate of the Governance Institute ofAustralia and an Associate of the Institute of Chartered Secretaries (UK).

Ms. Jann SkinnerNon-executive DirectorMs. Skinner, B Com, FCA, FAICD has extensive experience in audit, accounting and ininsurance. She worked with PricewaterhouseCoopers for almost 30 years, beginning hercareer with Coopers & Lybrand in 1975, and was a partner of the firm for 17 years beforeretiring in 2004. Jann was appointed as a non-executive director of QBE in 2014, whereshe also serves as Chair of the Risk and Capital Committee, Deputy Chair of the AuditCommittee and a member of the Remuneration Committee. She serves as a Director ofEnstar Australia Group, the Create Foundation Limited, HSBC Bank Australia Limited, andthe Tasmanian Public Finance Corporation. Jann is a Fellow of both CharteredAccountants Australia & New Zealand, and the Australian Institute of Company Directors.

24

Page 25: ASX:TLX - Jefferies...Metastatic prostate cancer : Diagnostic (pre- NDA), Therapeutic (Ph III) Renal (kidney) cell cancer : Diagnostic (Ph III), Therapeutic (Ph II) Brain cancer (glioblastoma)

International Operations

25

Dr. Shintaro Nishimura (President, Telix Japan)Shintaro is a highly-experienced drug development and commercialization professional, with particularemphasis on the use of molecular imaging in drug development. Prior to Telix, Shintaro held seniorpositions at Eli Lilly, ImaginAb and Astellas, as well as academic appointments at Kyoto PrefectureUniversity of Medicine, the University of Tsukuba and Tokohu University. Dr. Nishimura received hisdoctorate in organic chemistry from Keio University and was a post-doctoral researcher at the University ofMichigan Medical School.

Ms. Odile Jaume (President, Telix Europe)Odile leads Telix’s European commercial activities, based in Brussels. Prior to joining Telix, Ms. Jaumeheld a variety of senior product management, marketing and commercial roles at Molecubes, Siemens, CTIMolecular Imaging and IBA. Ms. Jaume’s qualifications include an M.Sc in material science from theUniversité Catholique de Louvain (UCL) and an MBA from the University of Chicago, Booth School ofBusiness.

Dr. Bernard Lambert (President, Telix USA)Bernard was Vice President, CMC and Radiopharmaceutical Development at Zevacor and IBA Molecular,and led the manufacturing of 124I-girentuximab (the predecessor to Telix’s TLX250 product) that wasstudied in the Phase III REDECT trial by Wilex AG. A radiochemist by training, Dr. Lambert has a Ph.D inChemistry from the University of Liège.

Page 26: ASX:TLX - Jefferies...Metastatic prostate cancer : Diagnostic (pre- NDA), Therapeutic (Ph III) Renal (kidney) cell cancer : Diagnostic (Ph III), Therapeutic (Ph II) Brain cancer (glioblastoma)

Scientific Advisory BoardDr. Rodney HicksChief of Nuclear Medicine and Radiology, Peter MacCallum Cancer Centre(Melbourne, Australia). One of the world’s radio-pharmaceutical clinicalthought leaders and strong advocate for the integration of PRRT/RIT intooncology standard care.

Dr. Jean-Francois ChatalProfessor, Univ. of Nantes (Nantes, France). Prof. Chatal pioneered theuse of antibody-targeted therapies in nuclear medicine.

Dr. Jason LewisChief of Radiochemistry, Vice-Chair of Radiology at MSKCC (NY, USA).Internationally recognized for innovation in the clinical production ofradiopharmaceuticals.

Dr. Klaus KopkaHead of the Division of Radiopharmaceutical Chemistry of the GermanCancer Research Center (DKFZ) Heidelberg, Germany. His researchinterests focus on Radiopharmaceutical Sciences in combination withLabelling Chemistry and Medicinal Chemistry. A thought leader in PSMAtargeting ligands.

Dr. Neil BanderChair of Urology at Weill Cornell Medical Centre (NY, USA). First led thedevelopment of PSMA-targeting radiopharmaceuticals for prostatecancer, discoverer and developer of huJ591 (anti-PSMA mAb)technology.

Dr. Chaitanya DivgiRetired ex-Columbia / UPenn radiology and nuclear medicine.Experienced regulatory adviser and clinical translation consultant. Ledthe original clinical development of Girentuximab (TLX250).

Dr. Samuel SamnickAn accomplished radiopharmaceutical researcher stationed at theUniversity of Wurzburg. He is a pioneer in the use of imaging and nuclidetherapy targeting LAT1.

Dr. Richard BaumProfessor of Nuclear Medicine, Chairman & Clinical Director, Departmentof Molecular Radiotherapy at Zentralklinik Bad Berka, Germany. He is athought-leader in the field of theranostic technology and has been one ofthe pioneers of peptide radiotherapy.

26

Page 27: ASX:TLX - Jefferies...Metastatic prostate cancer : Diagnostic (pre- NDA), Therapeutic (Ph III) Renal (kidney) cell cancer : Diagnostic (Ph III), Therapeutic (Ph II) Brain cancer (glioblastoma)

Near-Term Catalysts

End-June : report outcome on pre-Phase III IND meeting with FDA for ZIRCON (renal imaging)

End-July : report outcome on FDA pre-NDA meeting with FDA for illumetTM (prostate imaging)

End-July : Commercial / collaboration update for renal therapy program, including finalization of STARLIGHT protocols (combo I-O programs)

End-Aug/Early-Sept : FDA feedback on Phase III PROSTACT prostate cancer therapy trial design, commencement of run-in study in Australia (subject to TGA approval)

End-Sept/Early-Oct : Initial dose escalation of IPAX-1 (glioblastoma) Phase I/II completed

27

Page 28: ASX:TLX - Jefferies...Metastatic prostate cancer : Diagnostic (pre- NDA), Therapeutic (Ph III) Renal (kidney) cell cancer : Diagnostic (Ph III), Therapeutic (Ph II) Brain cancer (glioblastoma)

www.telixpharma.com