Telix Pharmaceuticals Limited · ASX:TLX
Telix Pharmaceuticals — Corporate Update (October 2019)
19 slides from Telix Pharmaceuticals's corporate update, October 2019
Slide 1: Precision Oncology Clinical Trial Program Update Q3 2019
Precision Oncology Clinical Trial Program Update Q3 2019
Slide 2: Important notices & disclaimer
Important notices & disclaimer This Presentation contains summary information about Telix Pharmaceuticals Limited ACN 616 620 369 Investment risk (Telix or the Company) and its activities as of 31st of October 2019. The information in this Presentation An investment in Telix shares is subject to inv
Slide 3: Executive summary
Executive summary • ZIRCON Ph III (renal cancer imaging) : EU/AUS recruiting, US to start Q1 ‘20 ➢ Expect completion of enrolment Q2 2020 • ZIRDAC Japan (Ph I/II bridging study to ZIRCON) : Study approved – first patient in expected next month (December ‘19) • ENHANCING study (prostate cancer imagin
Slide 4: Technology and Product Overview
Technology and Product Overview 4
Slide 5: Telix's core technology is Molecularly Targeted Radiation (MTR)
Telix’s core technology is Molecularly Targeted Radiation (MTR) MTR Systemic administration Targeted delivery of radiation to cancer cells radioactive targeting agent that binds isotope to a cancer specific marker Unique markers or “targets” on cancer MTR is administered via the blood MTR precisely
Slide 6: MTR enables precise imaging of the cancer
Positron Emission Tomography – “PET” MTR enables precise imaging of the cancer Imaging ✓ Patient selection – ensuring the patient receives the right therapy ✓ Therapy optimisation – tailoring the radiation dose to the patient’s actual disease burden ✓ Early revenue generation – imaging product devel
Slide 7: Telix's strategy for developing clinically-validated MTR therapeutics
Telix’s strategy for developing clinically-validated MTR therapeutics ✓ Focus on MTR technologies that are well validated by existing data – manage clinical risk ✓ Combine with companion imaging agent targeting the same cancer-specific marker ✓ Integrate with the existing standard of care for cancer
Slide 8: Why is MTR so effective at treating cancer?
Why is MTR so effective at treating cancer? Benefit Impact Precise Minimal “off-target” damage to surrounding healthy tissues / organs Systemic Targets cancer cells wherever they are in the body Durable Targets cancer cells and also destroys the tumour micro-environment Multi-modal Directly kills ca
Slide 9: Telix's clinical pipeline focuses on three main cancers
Telix’s clinical pipeline focuses on three main cancers Isotope Target Agent Phase I Phase II Phase III Commercial Therapy Renal 177Lu CA-IX Antibody TLX250 (Girentuximab) 89Zr CA-IX Antibody TLX250-Cdx (Girentuximab) Imaging Prostate 177Lu PSMA Antibody TLX591 TLX591 Therapy 68Ga Small Imaging PSMA
Slide 10: Summary
Summary ✓ Late stage pipeline of Molecularly Targeted Radiation (MTR) imaging and therapy products assets, significantly de-risked by extensive existing clinical data ✓ Three main focus areas : prostate, kidney and brain cancer ✓ Development of both imaging and therapy indications to optimise therap
Slide 11: Clinical Program Update
Clinical Program Update 11
Slide 12: Telix clinical trials
Telix clinical trials Trial Locations Indication Status Netherlands Kidney (Imaging) Complete (Ph I) EU (NL/AT/BE), Australia Brain / GBM (Therapy) Recruiting (Ph I/II) Australia Prostate (Imaging) Recruiting (Ph II) Japan Kidney (Imaging) Recruiting (Ph I/II) USA Kidney (Therapy) Pending (Ph II) US
Slide 13: Key clinical activity overview by geography
Key clinical activity overview by geography At least two sites in Canada are planned for Europe is the dominant recruitment territory for ZIRCON and ZIRCON, subject to HealthCanada approval. IPAX-1 (19 centres across both trials). Europe is also key for TLX250-CDx drug product is also manufactured i
Slide 14: Renal cancer program status
Renal cancer program status CT Imaging : ZIRCON Phase III study progressing nicely • Initial Australian and EU sites have launched well – adding patients weekly • All AU/EU sites will be fully online by end-Nov (21 sites in total) • US/Canadian regulatory submission expected to be completed by end-N
Slide 15: Prostate cancer program status
Prostate cancer program status Imaging : Preparing for market launch • Focus is on data collection building reference sites for market launch • Clinical/data collaboration with Bologna, Linz and Université libre de Bruxelles to support EU marketing authorisation • Three collaborative US academic IND
Slide 16: Brain cancer (glioblastoma) program status
Brain cancer (glioblastoma) program status Therapy : Successfully recruiting • 5/6 sites up and running (remaining EU site online before year-end, one site dropped) • Dosing for both single and triple fraction regimens has commenced • Some site initiations were delayed by EU summer - recruitment now
Slide 17: Commercialisation of prostate imaging product
Commercialisation of prostate imaging product US and EU marketing authorisations are a major focus • Successful pre-NDA meeting with the FDA and consultations with key EU competent authorities – clear guidance given • US New Drug Application (NDA) submission imminent 68Ga–PSMA-11 • EU marketing auth
Slide 18: Summary
Summary • Excellent progress over the last quarter, across all programs (globally) • Telix-sponsored trials are recruiting well alongside investigator- led studies to establish further clinical experience in advance of market launch for prostate cancer imaging (TLX591-CDx/ illumetTM) • Notable upcom
Slide 19: www.telixpharma.com
www.telixpharma.com () TELIX
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