Telix Pharmaceuticals Limited · ASX:TLX
Telix Pharmaceuticals — JP Morgan Virtual Healthcare Conference, January 2022
45 slides from Telix Pharmaceuticals's conference presentation, Jan 11, 2022
Slide 1: Precision Oncology: See it. Treat it.
For personal use only Precision Oncology See it. Treat it. Investor Presentation JP Morgan Virtual Healthcare Conference, January 2022
Slide 2: Disclaimer
Disclaimer For personal use only 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 warra
Slide 3: An established global leader in radiopharmaceuticals
An established global leader in radiopharmaceuticals For personal use only Extensive portfolio of diagnostic and therapeutic assets with compelling clinical data 12,150 patient doses in past 12 months1 FDA approval for TLX591-CDx (Illuccix®)2 18 active clinical studies (8 indications)3 Leading suppl
Slide 4: Our strategy: See It. Treat it.
Our strategy: See It. Treat it. Personalised, precision medicine For personal use only Targeted radiation delivery Systemically administered Imaging PET1 scanner TLX591-CDx2 (Prostate cancer) Unique cancer cell signature (target) 68Ga, 89Zr (diagnostic isotopes) Enables PET images of cancer TLX591 T
Slide 5: Radiation has never been more important in cancer care
Radiation has never been more important in cancer care Underpinned by the shift from radiation “in a box” to radiation “in a shot” For personal use only The evolution from external-beam radiation to From a ‘box’ To a ‘shot’ systematically-delivered and targeted radiation is transforming the role of
Slide 6: Telix is pioneering a new cancer modality
Telix is pioneering a new cancer modality Kidney Cancer Glioblastoma For personal use only Ph Name Asset Dx/Tx Ph Name Asset Dx/Tx III TLX250-CDx Dx I/II TLX101 Tx I/II TLX250-CDx Dx Breast Cancer II (IIT) TLX250 Tx Ph Name Asset Dx/Tx II (IIT) TLX250 Tx II OPALESCENCE (IIT) TLX250-CDx Dx I Emory Un
Slide 7: Core pipeline: oncology & rare diseases
Core pipeline: oncology & rare diseases For personal use only 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 cond
Slide 8: Strategic Priorities
Strategic Priorities For personal use only Use Illuccix as a Create a high-value Deliver on commercial Expand the commercial launchpad diagnostic portfolio value of therapeutics pipeline Establish Telix’s Kidney cancer imaging Advance late-stage assets in Novel targets, clinical leadership in urolog
Slide 9: Focus for 2022
Focus for 2022 Unlocking the value in our pipeline For personal use only • US reimbursement Illuccix global rollout • Additional global approvals including EU/UK, Canada • Commercial launch from late Q1 (US and AU) • Kidney cancer (TLX250-CDx) Phase III readout Commercialise diagnostics • Prepare fo
Slide 10: Recent milestones and near-term catalysts
Recent milestones and near-term catalysts For personal use only Recently completed milestones Upcoming milestones: Q1 2022 • Illuccix regulatory approvals granted in US • Illuccix commercial launch US and AU and Australia • US reimbursement for Illuccix: • HCPCS1 reimbursement submitted for Illuccix
Slide 11: Illuccix Imaging: Launching in Q1 2022
For personal use only Illuccix® Imaging Launching in Q1 2022 Telix Pharmaceuticals Limited (ASX: TLX) 11
Slide 12: Illuccix is now approved in the United States
Illuccix® is now approved in the United States Indication and usage information For personal use only Illuccix is a kit for the preparation of gallium-68 (68Ga) gozetotide (also known as PSMA-11) injection, a radioactive diagnostic agent indicated for positron emission tomography (PET) of prostate-s
Slide 13: Market opportunity for prostate imaging is expanding
Market opportunity for prostate imaging is expanding Due to growing incidence rates and practice guidelines For personal use only Potential clinical utilisation: US (REVISED) 1. Primary staging in newly diagnosed high-risk prostate 194,5101 cancer (NCCN) US (PRIOR) 146,000 57,000 2. Biochemical recu
Slide 14: Commercial launch plans - US
Commercial launch plans - US Commercial ramp up during Q1 2022 For personal use only 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 hi
Slide 15: PSMA-PET imaging emerging as standard of care in prostate cancer
PSMA-PET imaging emerging as standard of care in prostate cancer Inclusion in guidelines are driving clinical adoption and reimbursement For personal use only • National Comprehensive Cancer Network Guidelines® (NCCN Guidelines) include Ga-68 PSMA-11 PET/CT to be considered as an alternative to stan
Slide 16: The NOBLE Registry (TLX599-CDx): Nobody left behind
The NOBLE Registry (TLX599-CDx): Nobody left behind Improving access to PSMA imaging – beyond Illuccix For personal use only Chair • Collaboration to investigate utility of 99mTc-iPSMA SPECT1 imaging in prostate cancer • Global consortium of clinical sites and investigators with experience using 99m
Slide 17: Renal cancer program
For personal use only Renal cancer program A clinical leadership opportunity in diagnostics and therapy Telix Pharmaceuticals Limited (ASX: TLX) 17
Slide 18: TLX250-CDx / TLX250 overview
TLX250-CDx / TLX250 overview An exciting target, with potential application beyond kidney cancer For personal use only • Target: Carbonic Anhydrase IX (CAIX / CA9) Target: Dx Tx • Indication: Kidney cancer (clear cell renal cell carcinoma, ccRCC) CAIX / CA9 (TLX250-CDx) (TLX250) • Development status
Slide 19: Building a high-value diagnostics portfolio
Building a high-value diagnostics portfolio “Breakthrough Therapy” designation, clinical leadership opportunity For personal use only • Biologics License Application (BLA) consultation process has commenced, Phase III study in final stages of enrolment • TLX250-CDx is an investigational product bein
Slide 20: TLX250-CDx: delivering an unmet need in kidney cancer imaging
TLX250-CDx: delivering an unmet need in kidney cancer imaging For personal use only • 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
Slide 21: ZIRCON Phase III trial of TLX250-CDx for imaging of ccRCC
ZIRCON Phase III trial of TLX250-CDx for imaging of ccRCC Study overview For personal use only 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 standa
Slide 22: STARLITE Phase II trial of TLX250 for Treatment of ccRCC
STARLITE 2 Phase II trial of TLX250 for Treatment of ccRCC TLX250 in combination with immunotherapy For personal use only • STARLITE 2 now actively recruiting (screening patients) • Phase II trial of TLX250 plus nivolumab in with ccRCC who have progressed following prior immunotherapy •NCT03849118 E
Slide 23: CA9 indication expansion
CA9 indication expansion New understanding leads to potential for applications beyond kidney cancer For personal use only • A transmembrane protein and a tumor-associated carbonic anhydrase Potential Indication Status isoenzyme • Over-expressed in mutated ccRCC Bladder or Urothelial Cancer Commenced
Slide 24: Prostate cancer therapy
For personal use only Prostate cancer therapy Our vision for prostate cancer Telix Pharmaceuticals Limited (ASX: TLX) 24
Slide 25: Prostate cancer therapy assets overview
Prostate cancer therapy assets overview Next-generation therapy to follow TLX591 For personal use only • Target: Prostate Specific Membrane Antigen (PSMA) Target: PSMA TLX591 TLX592 • Indication: Prostate cancer • Clinical status: • TLX591: ProstACT GLOBAL Phase III + ancillary studies Targeting Eng
Slide 26: ProstACT program overview
ProstACT program overview Multiple opportunities to deliver insights into TLX591 For personal use only 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 • Ra
Slide 27: ProstACT GLOBAL Phase III study
ProstACT GLOBAL Phase III study Pivotal trial For personal use only TLX591 + Standard of Care (SoC) vs. SoC alone Eligible Patients TLX591 + Standard of care therapy • PSMA avid (defined by TLX591-CDx) • mCRPC1 Standard of care therapy • Progressed despite prior therapy with NAAD2 alone • Internati
Slide 28: ProstACT SELECT Phase study
ProstACT SELECT Phase 1 study Enhances patient selection and supports indication expansion For personal use only Treat the scan Correlation between imaging and therapy to optimise patient selection Eligible Patients TLX591 + Standard of care therapy • PSMA avid (defined by TLX591-CDx) Comparative im
Slide 29: ProstACT TARGET Phase II study
ProstACT TARGET Phase II study Expanding clinical data to include a front-line setting For personal use only 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 T
Slide 30: TLX591 differentiation
TLX591 differentiation Potential advantages with PSMA antibody approach For personal use only 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
Slide 31: TLX591 patient experience
TLX591 patient experience Off-target irradiation – quality of life matters For personal use only TLX591 Lacrimal, Parotid, Small molecule Submandibular Antibodies are functionally (salivary) glands Small molecule specific for tumour-expressed radioligands taken PSMA and do not “hit” most up by endog
Slide 32: Our long-term vision for prostate cancer
Our long-term vision for prostate cancer Improving access, imaging and treatment options for patients For personal use only • Further development of the PSMA target underpins our lifecycle management strategy for prostate cancer and vision to improve patient outcomes • PSMA pipeline includes imaging
Slide 33: Our clinical mission: support the patient every step of the way
Our clinical mission: support the patient every step of the way For personal use only Localised disease Advancing clinical stages Metastatic castrate resistant Radiation therapy +/- ADT Docetaxel, abiraterone (metastatic, First line: Radical prostatectomy non-castrate), apalutamide, Docetaxel; Sipul
Slide 34: CUPID trial
CUPID trial Next-generation alpha therapy, complements TLX591 For personal use only Study with 64Cu-TLX592 to show biodistribution and tumour targeting prior to targeted alpha therapy (TAT) with 225Ac-TLX592 Eligible Patients 225Ac-TLX592 64Cu-TLX592 • Prostate cancer patients with low-burden TAT me
Slide 35: Rare diseases program
For personal use only Rare diseases program High potential, high impact Telix Pharmaceuticals Limited (ASX: TLX) 35
Slide 36: TLX101-CDx / TLX101 overview
TLX101-CDx / TLX101 overview Orphan designation status granted for imaging and therapy candidates For personal use only • Target: Large amino acid transporter 1 (LAT-1) Dx Tx • Indication: Glioblastoma multiforme (GBM) Target: LAT-1 (TLX101- (TLX101) CDx) • Clinical status: • TLX101-CDx: Progressing
Slide 37: IPAX-I Phase I/II trial of TLX101 for the treatment of GBM
IPAX-I Phase I/II trial of TLX101 for the treatment of GBM1 TLX101 in combination with EBRT2 For personal use only • Multi-centre Phase I/II trial of TLX101 in combination with EBRT in patients with recurrent GBM • Primary endpoint: Safety and tolerability • Secondary endpoints include: MTD3, effica
Slide 38: Building on the IPAX-1 experience
Building on the IPAX-1 experience IPAX-2 will evaluate TLX101 in newly-diagnosed patients For personal use only • Progression of TLX101 program into front-line setting, Phase I/II study expected to commence in Q1 2022 • Initial dose finding study TLX101 plus standard of care (SOC) in patients with n
Slide 39: TLX66 CD-X / TLX66 overview
TLX66 CD-X / TLX66 overview Application across a range of conditions requiring bone marrow conditioning For personal use only • Target: CD66 (Cluster of differentiation 66) Dx Tx • Indication: Target: CD66 (TLX66- (TLX66) CDx) • TLX66-CDx: Scintigraphic bone imaging • TLX66: Bone marrow conditioning
Slide 40: New hope in a rare disease
New hope in a rare disease Progressing development of TLX66 in bone marrow conditioning For personal use only • SALA1 is a rare disease with a poor prognosis (median survival ~11 months if untreated) • Plasma cells in the bone marrow produce abnormal protein called ‘amyloid’ which accumulates Faulty
Slide 41: Future value creation
For personal use only Future value creation Focus on innovation and growth markets Telix Pharmaceuticals Limited (ASX: TLX) 41
Slide 42: Near-term growth opportunities
Near-term growth opportunities Expansion into new geographic markets For personal use only • China Grand Pharma partnership • NMPA consultations have commenced (Mainland China) • Regulatory filings for Illuccix Q1 2022 (Taiwan, Hong Kong) • Largest Asia Pacific market opportunity • Key bridging clin
Slide 43: Buildout of the Brussels (Seneffe) manufacturing facility
Buildout of the Brussels (Seneffe) manufacturing facility Vertical integration in Europe For personal use only • Seneffe will serve as the primary EU manufacturing site for Telix’s products • Will also be used manufacture 131I-based products for export NCT03849118 (i.e. TLX101) using Belgian-sourced
Slide 44: Future research and innovation focus
Future research and innovation focus For personal use only Targeted alpha MTR1 + Tumour Artificial Radio-guided therapy immuno-oncology microenvironment intelligence (AI) surgery "Next Generation" MTR sets the Combining MTR with Tools to Bringing molecular therapeutics with “groundwork” for standard
Slide 45: Precision Oncology: See it. Treat it.
For personal use only Precision Oncology See it. Treat it. www.telixpharma.com IR contact: Kyahn Williamson Email: kyahn.williamson@telixpharma.com
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