Telix Pharmaceuticals Limited · ASX:TLX
Telix Pharmaceuticals — Jefferies Healthcare Conference 2021
25 slides from Telix Pharmaceuticals's conference presentation, Jun 2, 2021
Slide 1: Telix Pharmaceuticals Limited - Jefferies Healthcare Conference June 2021
For personal use only Telix Pharmaceuticals Limited Jefferies Healthcare Conference June 2021
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: Telix at a glance
Telix at a glance… Extensive late stage product portfolio – diagnostics and therapeutics For personal use only ü Oncology with focus on prostate, renal, glioblastoma, hematologic cancers ü Immunology applications and high value rare diseases Major milestones achieved during 2020…despite COVID-19 ü I
Slide 4: Our technology: Molecularly-Targeted Radiation (MTR)
Our technology : Molecularly-Targeted Radiation (MTR) See It. Treat it. For personal use only Targeted radiation delivery Systemically administered Imaging PET scanner TLX591-CDx1 (Prostate cancer) Unique cancer cell signature (target) 68 Ga, 89Zr (diagnostic isotopes) Enables PET images of cancer T
Slide 5: Deep pipeline in oncology, rare diseases
Deep pipeline in oncology, rare diseases Targeting Cancer Cell Radioactive Molecule Target Isotope Phase I Phase II Phase III Commercial For personal use only Small 68Ga PSMA TLX591-CDx (68Ga-PSMA-11, Illuccix®) Imaging molecule 177Lu Antibody PSMA TLX591 (177Lu–rosopatamab) Therapy Prostate Antibod
Slide 6: Board of Directors
Board of Directors : Medical, radiopharmaceutical, risk and governance experience Chairman For personal use only Mr. Kevin McCann, AO Chairman of China Matters, a Pro-Chancellor of the University of Sydney, a Trustee of the Sydney Opera House, Director of E&P Financial Services Group. Former Chairma
Slide 7: Prostate Cancer Program
For personal use only Prostate Cancer Program Telix Pharmaceuticals Limited (ASX: TLX) 7
Slide 8: Flagship product: TLX591-CDx (Illuccix) prostate cancer imaging
Flagship product : TLX591-CDx (Illuccix®) prostate cancer imaging New Drug Application (NDA) submitted to the US FDA in September 20201 For personal use only • NDA accepted for filing in December 2020, currently in review • FDA mid-cycle review meeting occurred on the 2nd March 2020 • Late-cycle rev
Slide 9: Planned US Illuccix roll-out: the gallium wave
Planned US Illuccix® roll-out : the “gallium wave” Illuccix® (Kit for the preparation of 68Ga-PSMA-11) is an investigational product and has not attained a marketing authorisation in any jurisdiction, For personal use only including the United States. Product launch in the United States is subject t
Slide 10: EU marketing authorisation application for TLX591-CDx (Illuccix)
EU marketing authorisation application for TLX591-CDx (Illuccix®) Marketing Authorisation Application submitted in April 2020 For personal use only • Danish Medicines Agency serves as the reference Competent Authority for Telix’s submission • 14 EU member countries included in Telix’s submission, in
Slide 11: Regulatory submissions for TLX591-CDx in other markets
Regulatory submissions for TLX591-CDx (Illuccix®) in other markets Telix is working towards a global product launch1 For personal use only • Granted Priority Review status by Australian TGA in December 20202 • TGA submission accepted April 2021, with 150-day dossier review and approval • New Drug Su
Slide 12: Illuccix approval timelines (estimated)
Illuccix® approval timelines (estimated) 2020 2021 For personal use only Sep Oct Nov Dec Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec Filing 24/11 02/03 Review 16/06 Decision 23/09 Acceptance Mid-cycle Late-cycle PDUFA Action Date review review (latest date) National Assessment 3/12 Clock-stop /
Slide 13: Prostate cancer imaging total addressable market ~USD $900M
For prostate cancer imaging with TLX591-CDx (Illuccix®) the total addressable market (TAM) is ~USD $900M For personal use only Annual incidence of prostate cancer in Telix’s US & EU markets1 478,0002 Patients with prostate cancer eligible for PET imaging with TLX591-CDx (Illuccix®), across 4 potenti
Slide 14: ProstACT Phase III trial of TLX591 for the treatment of mCRPC
ProstACT Phase III trial of TLX591 for the treatment of mCRPC1 For personal use only • Pre-IND meeting with US FDA in November 2020 enabled ProstACT trial to be finalised ü International, multi-centre, Phase III RCT2 in ~390 patients with PSMA-expressing metastatic prostate cancer (mCRPC), experienc
Slide 15: Renal Cancer Program
For personal use only Renal Cancer Program Telix Pharmaceuticals Limited (ASX: TLX) 15
Slide 16: ZIRCON Phase III trial of TLX250-CDx for imaging of ccRCC
ZIRCON Phase III trial of TLX250-CDx for imaging of ccRCC1 For personal use only NCT03849118 NCT03849118 • International, multi-centre, Ph III trial in ~252 patients with an indeterminate renal mass suspicious of ccRCC ü Primary endpoint: Sensitivity and specificity of PET/CT imaging with TLX250-CDx
Slide 17: ZIRDAC-JP Phase I/II bridging trial of TLX250-CDx in Japan
ZIRDAC-JP Phase I/II bridging trial of TLX250-CDx in Japan Zirconium Dosing and Comparison in Japan For personal use only • Japanese, multi-centre, Phase I/II trial in ~40 patients with an indeterminate renal mass suspicious for ccRCC • Primary endpoints NCT03849118 NCT03849118 ü Phase I – Safety an
Slide 18: STARLITE Phase II trial of TLX250 for Treatment of ccRCC
STARLITE Phase II trial of TLX250 for Treatment of ccRCC TLX250 in combination with immunotherapy For personal use only • Phase II trial of TLX250 plus nivolumab in ~30 patients with ccRCC who have progressed following prior immunotherapy NCT03849118 •NCT03849118 Primary endpoint ü To determine the
Slide 19: Glioblastoma Program
For personal use only Glioblastoma Program Telix Pharmaceuticals Limited (ASX: TLX) 19
Slide 20: 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 up to 44 patients with recurrent GBM NCT03849118 ü Primary endpoint: Safety and tolerability NCT03849118 ü Secondar
Slide 21: Bone Marrow Conditioning / Rare Diseases Program
For personal use only Bone Marrow Conditioning / Rare Diseases Program Telix Pharmaceuticals Limited (ASX: TLX) 21
Slide 22: TRALA Phase I/IIa trial of 90Y-besilesomab (TLX66) in SALA
TRALA Phase I/IIa trial of 90Y-besilesomab (TLX66) in SALA1 Targeted Radiotherapy for Amyloid Light Chain Amyloidosis (TRALA)2 For personal use only • SALA Dysfunctional ü Rare disease with a poor prognosis (median survival ~11 months if untreated) plasma cells NCT03849118 NCT03849118 ü Plasma cells
Slide 23: Looking Ahead
For personal use only Looking Ahead Telix Pharmaceuticals Limited (ASX: TLX) 23
Slide 24: Three major inflections in 2021
Three major inflections in 2021 For personal use only Commence ProstACT Complete ZIRCON Launch Illuccix® ZIRCON Commence Phase III therapy trial Complete Phase III trial Regulatory approval Australia initially (H1) BLA1 preparation Commercial launch EU and US (H2) Second commercial product First com
Slide 25: telixpharma.com
For personal use only telixpharma.com
Telix Pharmaceuticals — Jefferies Healthcare Conference 2021 on 6ix