Download - Precision Urologic Oncology
Precision Urologic
Oncology
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, including the United States. 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. None of the products or potential
products described in this presentation have received a marketing authorization in any jurisdiction.
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Company Snapshot
• Telix is a late-stage biotech developing an advanced pipeline of molecularly-targeted
radiation (MTR) products. Founded in 2015
• Clear unmet medical needs in high-value oncology segments, multi $Bn market opportunity
• Board : Kevin McCann (ex-Chairman, Macquarie Bank), Mark Nelson (Caledonia), Jann
Skinner (ex-PwC Partner), Oliver Buck (ITM Group), Andreas Kluge (ABX CRO)
• Melbourne (Australia) HQ with operations in USA, Europe and Japan – 50 headcount
• January 2017 : $8.5m in “seed” funding at 18c (equivalent)
• November 2017 : ASX IPO – raised $50m at 65c
• July 2019 : $45m financing (placement + SPP) at $1.30
Indication Diagnostic Therapeutic
Metastatic prostate cancer Pre-NDA Phase III
Renal (kidney) cell cancer Phase III Phase II
Brain cancer (glioblastoma) Phase I/II
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• Management / Board ~30% of the company
• Predominantly institutional shareholder base: Fidelity, Portland, Acorn Capital, UV Cap
• Early revenue generation from prostate cancer imaging product
• Financed through to commercialisation of the first two products (prostate/renal imaging)
$1.52(25 July 2019)
Mkt. Cap: ~A$380m
Disease Focus Oncology
Clinical Stage Phase I - III
Shares on Issue ~250m
Options on Issue 17.7m
Cash on Hand ~AUD $60m
ASX Ticker TLX
Financial Snapshot
IPO Price: $0.65
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Our Approach : Molecularly-Targeted Radiation (MTR)
MTR works by chemically
“linking” radioactive isotopes
to targeting molecules that
are very specific for cancer
cells. At low doses, this
enables the location of the
cancer cells to be pinpointed
using PET imaging. At high
doses the patient is very
effectively treated
We distinguish the term MTR
because there are many
“radiopharmaceuticals” that
are not targeted. Telix is
targeting agent agnostic – we
use both antibody and small-
molecule approaches
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• 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 then 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
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1 Courtesy of Dubai Nuclear Medicine & Molecular Imaging Center, UAE 2 Courtesy of Radboud University Medical Centre, Netherlands3 Courtesy of ZentralKlinik Bad Berka, Germany
Nuclear Medicine’s Biggest Problem – Investment (or Lack Thereof)
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What’s Changed?
• New isotopes (177Lu, 225Ac) that are user-friendly, “drug-like”
• Global supply chain evolved
• Out of the basement and into the outpatient setting
• “Next gen” oncologists love their PET scans
• Data sets grew in size, significance
• Bigger data demonstrated affirmed the astonishingdiagnostic and therapeutic benefit
• Pharma has realized that targeted radiation is a matchmade in heaven for immuno-oncology
• Decent transactions (Algeta, Endocyte, AAA, Sirtex, Blue Earth)
• The rest is history …
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The “Awakening”
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177Lu-DOTATATE
SoC (Octreotide)
• NETTER trial (AAA)
was considered
ground-breaking in a
very challenging type
of cancer
• Impressive survival
benefit in NETs
• Difference between
comparator arms was
essentially just the 177Lu
Telix’s Clinical PipelineR
enal
Pro
sta
teG
BM
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 PSMASmall
Molecule
131I LAT-1Small
Molecule
124I LAT-1Small
Molecule
Therapy
Imaging
Therapy
Imaging
Therapy
Imaging
Shaded arrows indicate the company’s development objectives over the next 18 months
CDx denotes “Companion Diagnostic”
TLX591
TLX591-Cdx (PSMA-11)
TLX101
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Backup
Global Supply Chain and Distribution Network
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✓ Multiple commercial partnerships withleading global healthcare companies
✓ For clinical trials andearly commercialproduct roll-out
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
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TLX591 : Significant benefit … 40+ months of survival in mCRPC
TLX591
2x 45mCiPSMA-617*
(Novartis)
*Data from the German multi-center trial for PSMA-617 :
Rahbar et al. (JNM 2017)
Retrospective cross-
trial comparison
between PSMA-617
(Novartis) and TLX591
(Telix)
Median overall
survival (OS) is >40
months (Telix) vs 15
months (Novartis)
Survival data now
published in Cancer
(March ’19)
Overall Survival
(P=0.011)
What has Telix Done Differently?
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Commercial
▪ Commitment to “theranostics”
▪ Disruptive pipeline with extensive clinical data – de-risk
▪ Properly fund the development
▪ Rapidly built a global supply chain / production network
Technical
▪ Developed scalable processes, automation
▪ Invested in linker technologies that give better product profiles, COGS
▪ Focus on chemistry that allows rapid room-temperature processes => enables production to be turned into consumables
Our Secret Weapon : Australia
• Outstanding nuclear medicine, people
• Capable university labs / pre-clinicalfirepower
• World-class infrastructure
• Therapeutic Goods Administration (TGA) isfairly pragmatic
• A variety of manufacturing options fromclinical trial scale to scale-up
• Gov’t incentives
ANM Project
OPAL
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Front-Intervention in Prostate Cancer : Surgery
~165,000
new cases
annually
(US)
~90,000
prostatectomies~40,000
recurrences
~30,000
deaths
Most common cancer in men (after skin cancer) and second
leading cause of death (after cardiovascular disease).
One in seven Australian (and Kiwi) men will get prostate cancer
(robotic surgery)
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Local DiseaseLocally
Advanced
Lymph Node
MetsDistant Mets
Low Risk Medium Risk High Risk
Active
Surveillance
Radical
Prostatectomy
Radical
Prostatectomy
Radical
ProstatectomyEBRT
EBRT +
Endocrine Tx
EBRTEBRT + LDR
Brachytherapy
EBRT + HDR
+ Endocrine Tx
LDR
Brachytherapy
EBRT +
Endocrine Tx Watchful
Waiting
Radical
P’tectomy ++
P’tectomy +
Endocrine TxEndocrine Tx
EBRT +
Endocrine Tx
EBRT +
Endocrine Tx
Bone Seeking
Agents
EBRT + HDR
+ Endocrine TxEndocrine Tx
Symptom
Oriented Tx
Watchful
Waiting
Active
Surveillance
Watchful
Waiting
Watchful
Waiting
Watchful
Waiting
Why is imaging important to PCa management?
A lot of watching and waiting…
EBRT = External Beam Radiation Therapy
“Typical” PCa treatment strategies (darker illustrate trend
toward systemic therapy).
The Big Challenge : High Risk Men
Drugs(Chemo/Hormone
Therapy)
Years …
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Bone scan
Telix’s Solution? Superior imaging…
EVERYWHERE
Tumour Load Low Medium High
PSA Level 4.8ng/ml 454ng/ml 2860ng/ml
Before it
becomes
this:
If we can
find this:
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We give
prostate
cancer
patients
new
options.
Two Ways to Product PET Tracers for Prostate Cancer Imaging
Cyclotrons. 18F is the most commercially used
isotope (2 hour half-life). Very high-scale
production but also high infrastructure /
operating cost, ageing install base. Scheduled
production means less patient flexibility and
challenging to deliver product to the “last mile”
Generators. For PET imaging we use 68Ge/68Ga
(gallium) generators. This is a portable radiation
source that “lives” in the hospital radiopharmacy
and is replenished every 6 months or so.
Convenient, dose-on-demand, easy to use. Lower
throughput but can be used anywhere. 68Ga has a
short half-life of 68 minutes which means that a
dose needs to be prepared very quickly
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68Ga Generator-based complete kit
• Proprietary formulation of PSMA-11
• High quality (cGMP) production
• Use results in highly reproducible image quality
• Elution accessories included. Generator + kit = dose
Fast. Cost-Effective. Convenient. Accessible
• Patient-ready dose - 5 min. room temp incubation
• PET agent “on-demand” - minimises “no show” losses
• No synthesizer - equipment, process and time savings
• Superior use of 68Ga elution / activity
• Nuc pharmacy sufficient, no cyclotron required
Making PSMA Imaging Accessible
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Adoption is Growing Fast …
8
1
38 1
5
3
7
1
5
5
12
Australia: 1
UAE: 1
3
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✓ >100 sites around the world
use Telix’s product routinely
or in clinical trials
✓ Mostly large cancer centres
that are capable of doing
10-15 pts a week (upon
product approval)
✓ On track to deliver between
10,000 and 15,000 doses in
2019 (globally)
EU and US product approval
expected 1H 2020
*68Ga-PSMA-11 is an investigational product and
has not received marketing authorization in any jurisdiction 23
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 IND submission planned Sept 2019
▪ Primary end-point : sensitivity/specificity for clear
cell RCC vs histology (from surgical resection)
89Zr-DFO-
girentuximab
Carbonic
Anhydrase IX
(CAIX)
>300 patients
imaged with124I, 89Zr
Phase III
(Confirmatory)
Benign
Malignant
ccRCC
▪ Prior Ph III trial
with 124I
▪ ZIRDOSE 124I
to 89Zr bridging
study complete
▪89Zr = superior
image quality,
clinical utility,
economics
NCT03849118
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TLX250-CDx (Renal Imaging) Clinical Proposition
CT Scan TX250 PET
TX250 PET
Courtesy – Radboud Univ.
TX250PET Scan
Bone lesion
• TLX250-CDx re-stages about 30% of kidney cancer patients
• Optimise surgery / systemic therapy• No meaningful product competition• Selling synergies with IllumetTM
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Near-Term Inflection Points
✓ End-July : report outcome on FDA pre-NDA meeting (24th of July) with
FDA for illumetTM (prostate imaging) – to discuss product approval
✓ End-July : Commercial / collaboration update for renal cancer therapy
program, including finalization of STARLITE Phase II protocols (combo
immuno-oncology programs)
✓ End-Aug/Early-Sept : FDA guidance on Phase III PROSTACT prostate
cancer therapy trial design, commencement in Australia (subject to
TGA approval)
✓ End-Sept/Early-Oct : Initial stage of IPAX-1 (glioblastoma therapy)
study expected to complete
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