Investor Presentation Telix
Investor Presentation Telix
Investor Presentation Telix
Investor Presentation
JP Morgan Virtual Healthcare Conference, January 2022
Disclaimer
The information contained in this 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 may contain 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 directors, 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.
Telix’s lead product, Illuccix® (TLX591-CDx) for prostate cancer imaging, has been approved by the Australian Therapeutic Goods Administration (TGA), and the U.S.
Food and Drug Administration (FDA). Telix is also progressing marketing authorisation applications for Illuccix in the European Union and Canada. With the exception
of Illuccix in the US and Australia and Scintimun®, none of Telix’s products have received a marketing authorisation in any jurisdiction.
1. Clinical trial doses and magisterial / compassionate use of TLX591-CDx. 12 months from Q4 2020 3. Includes partnered investigator-led studies.
2. United States Food and Drug Administration – ASX 20/12/21
Telix Pharmaceuticals Limited (ASX: TLX) 3
Our strategy: See It. Treat it.
Personalised, precision medicine
(diagnostic isotopes)
Enables PET
images of cancer
TLX591
Therapy (Prostate cancer)
Radioactive
isotope
Targeting agent
(a small molecule or antibody) 177Lu, 131I, 225Ac
binds selectively to a (therapeutic isotopes)
cancer cell
Enables precise radiation
delivery to the cancer
1. Positron emission tomography
2. Courtesy of Ammar Chaudhry MD, City of Hope, Duarte CA, USA.
Telix Pharmaceuticals Limited (ASX: TLX) 4
Radiation has never been more important in cancer care
Underpinned by the shift from radiation “in a box” to radiation “in a shot”
Telix is driving the integration of nuclear medicine and medical oncology with more
targeted and personalised therapy and patient-friendly dosing regimens
Shaded arrows indicate completion expectations in the next 12 months. *Registry Study
1. Prostate-specific membrane antigen. 3. Large amino acid transporter 1 5. Cluster of differentiation 66.
2. Carbonic anhydrase IX. 4. Bone marrow conditioning and rare disease.
Telix Pharmaceuticals Limited (ASX: TLX) 7
Strategic Priorities
Establish Telix’s Kidney cancer imaging Advance late-stage assets in Novel targets, clinical
leadership in urologic agent addresses major the core pipeline that benefit applications and
oncology unmet need, builds on from diagnostic market manufacturing
Illuccix engagement entrance technologies
• US reimbursement
Illuccix global rollout • Additional global approvals including EU/UK, Canada
• Commercial launch from late Q1 (US and AU)
(2) 52,000
35,000
(3) 22,000
(4) 17,000 28,000
1. American Cancer Society. Cancer Facts & Figures 2021. Atlanta, GA: American Cancer Society; 2021.
2. EU countries included in MAA submission to Danish Medicines Authority on 30 April 2020.
Telix Pharmaceuticals Limited (ASX: TLX) 13
Commercial launch plans - US
Commercial ramp up during Q1 2022
Positioned to capture meaningful market share
• Access to ~90% of eligible PET sites
• Distribution network holds 60% market share of nuclear medicine
market in the US
• On-demand pharmacy-based production with a
high yield product
• Customer and patient scheduling flexibility
• Two of the four main Radiology Benefit Managers (RBMs) - AIM Specialty
Health3 and NIA Magellan4 – are now recommending PSMA-PET
representing a significant portion of commercial payor (health insurance)
reimbursement policies
Chair
• Collaboration to investigate utility
of 99mTc-iPSMA SPECT1 imaging
in prostate cancer
• Global consortium of clinical sites
and investigators with experience
using 99mTc-iPSMA
• Geographic focus on developing
markets or remote regions where Dr. Ryan
Yudistiro
access to PET imaging is limited2 Dr. Akintunde
Orunmuyi
Indonesia
Nigeria
• Total addressable
market value in US
and Europe estimated
Yearly estimated
at US$300-400M Yearly new cases,
number of deaths,
worldwide, both
• Potential for market worldwide, both
sexes, all ages
leadership, given sexes, all ages
limited patient options 431,288 179,368
• Addresses a major
unmet medical need
for more accurate
patient staging
Eligible Patients
• Single indeterminate renal mass ≤7cm Surgical removal
TLX250-CDx
diameter on CT or MRI suspicious for ccRCC & histology as
PET/CT scan
• Scheduled for surgical removal as part of standard of truth
management plan
• International, multi-centre, Phase III trial in ~252 patients with an indeterminate renal mass suspicious of ccRCC
• Primary endpoint: Sensitivity and specificity of PET/CT imaging with TLX250-CDx to non-invasively detect ccRCC
in patients with indeterminate renal masses, using histology as standard of truth (after surgical removal)
• 35 sites participating
• > 85% recruited, progressing well towards completion
• United States, Canada, Europe, Turkey, Australia
• ZIRDAC-JP Phase I/II bridging trial of TLX250-CDx in Japan
• Phase I objectives met, Phase II in planning, potential to include Chinese patients to expand Asian utility
Radiogenomics study
• ~50 patients SELECT (Ph I) – radiogenomics
• 1st line metastatic study enhances patient selection
prostate cancer (mCRPC) and supports indication expansion
Treat the scan
• Rapid recruitment Correlation between imaging and therapy to optimise patient selection based on a “theranostic” approach
• International, multi-centre, Phase III RCT in ~390 patients with PSMA-expressing metastatic prostate cancer
(mCRPC), experiencing disease progression following prior treatment with an anti-androgen drug (NAAD)
• Primary endpoint: radiographic progression-free survival (rPFS)
• Secondary endpoints include: overall survival, quality of life, safety
• 2:1 randomisation and enrichment of study population, patient selection with TLX591-CDx
• Status: ProstACT GLOBAL has been initiated in Australia and will add EU, US and potentially Chinese sites
over the next six months, subject to satisfying the requisite regulator approvals
• Radiogenomics study to enhance patient selection for ProstACT GLOBAL and support indication expansion for
Telix’s PSMA therapeutic portfolio, based on a “theranostic” approach
• Primary endpoints: biodistribution, safety and tolerability
• Secondary endpoints include: correlation between imaging and therapy molecules, radiographic
progression-free survival, PSA response
• Status: Actively recruiting (screening patients)
Telix Pharmaceuticals Limited (ASX: TLX) 28
ProstACT TARGET Phase II study
Expanding clinical data to include a front-line setting
Early data in front line care In partnership with:
Efficacy data in patients in their first recurrence
Eligible Patients
TLX591 + External Beam
• PSMA avid (defined by TLX591-CDx) Radiation Therapy
• Oligometastatic early recurrence (EBRT)
• Single arm Phase II study in Australia in 50 patients with PSMA-expressing biochemically recurrent oligometastatic
prostate cancer, in combination with external beam radiation therapy (EBRT)
• To determine the efficacy, biodistribution and combination dosimetry of TLX591 plus EBRT, including dose to tumour
• Primary endpoint: radiographic progression-free survival
• Secondary endpoints include: overall survival, quality of life, safety
Eligible Patients
• Status: Patient screening to commence early 2022 (subject to ethics approval)
Potential for improved overall survival (OS) in advanced metastatic disease, with
Efficacy
40+ months OS reported to date1
Reduced potential for off-target side-effects; dry eye, xerostomia (salivary gland
Patient comfort
ablation), back pain (ganglia irradiation)
Patient-centric Short treatment duration/significantly fewer hospital visits – two weeks total
regimen vs. 36 weeks, supports close supervision by medical oncology
imaging
Rising PSA Radiogenomics and
ADT (non-castrate) tumour targeting of
Combination of EBRT TLX591
and TLX591 in early
biochemical recurrence Second line +
Clinical trial
Second line:
TLX592 (225Ac) Cabazitaxel; Abiraterone
Enzalutamide; Radium 223
Olaparib; Rucaparib
Asymptomatic Symptomatic
Non-metastatic Metastatic
Castration-sensitive Castration-resistant
Time / disease progression
• TAT is becoming an important area of PSMA therapy research, particularly in men that are no longer responding to 177Lu
• TLX592 antibody re-engineered to clear ~10x faster from the body, while maintaining specificity for tumour-expressed
PSMA (liver cleared, no exocrine uptake)
• Designed for delivering TAT (225Ac) intended for:
i) Early-stage metastatic disease (e.g. biochemical recurrence (BCR)) and
ii) Late-stage disease when 177Lu-PSMA therapy is no longer providing treatment efficacy
• Single arm, open-label, first-in-human (FIH) study of 64Cu-TLX592 in men with metastatic prostate cancer using PET
• Primary endpoint: Determine the safety and tolerability, pharmacokinetics, whole body biodistribution and
radiation dosimetry of 64Cu-TLX592 using PET as a proxy for 225Ac-TLX592 TAT
• Status: Actively recruiting – multiple patients dosed in imaging phase
Telix Pharmaceuticals Limited (ASX: TLX) 34
Rare diseases program
High potential, high impact
"Next Generation" MTR sets the Combining MTR with Tools to Bringing molecular
therapeutics with “groundwork” for standard of care maximise clinical imaging into the
alpha-emitting cancer treatments for insights gained from operating room (OR)
radioisotopes immuno-therapy in improved efficacy with imaging, link to
combination biomarker-driven therapeutic outcomes
patient selection
1. Molecularly targeted radiation
Telix Pharmaceuticals Limited (ASX: TLX) 44
Precision Oncology
See it. Treat it.
www.telixpharma.com
IR contact: Kyahn Williamson
Email: [email protected]