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Telix Pharmaceuticals Ltd — Investor Presentation 2021
Feb 25, 2021
31324_rns_2021-02-25_dd9e20d5-f124-449d-980c-65af4c3aa046.pdf
Investor Presentation
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Before
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GBM treatment response in an IPAX-1 study patient
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After
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26 February 2021
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Disclaimer
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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. None of the products or potential products described in this presentation have received a marketing authorisation in any jurisdiction.
Telix Pharmaceuticals Limited (ASX: TLX)
Contents
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2020 Operating Summary 6 Clinical Program Summary 10 Prostate Cancer Program 12 Renal Cancer Program 19 Glioblastoma Program 23 Bone Marrow Conditioning / Rare Diseases Program 25 Partnerships and Transactions 27 Looking Ahead 32
Telix Pharmaceuticals Limited (ASX: TLX)
Telix: A Snapshot
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Late stage MTR[1] product portfolio
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✓ Oncology with focus on prostate, renal, glioblastoma, hematologic cancers
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✓ Immunology applications and high value rare diseases
Major milestones achieved during 2020…despite COVID-19
✓ Illuccix[® ] (prostate cancer imaging):
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Regulatory filings in US, EU, Canada, Australia
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Commercial distribution agreements in US (Cardinal Health and Pharmalogic) and major EU & APAC territories
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✓ Licensed production facility acquired in Seneffe, Belgium from Eckert & Ziegler AG
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✓ China Grand Pharma transaction: Up to $400M+ value, delivers long-term clinical & commercial partner for Greater China region
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✓ TheraPharm acquisition: Broadens development pipeline to hematologic oncology, bone marrow transplantation, rare diseases ✓ Multiple strategic collaborations: Varian Medical Systems, RefleXion, Mauna Kea Technologies
Significant value events anticipated in 2021
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✓ Illuccix[® ] : Regulatory approval and commercial launch in US, EU, Canada, Australia. First commercial product revenue
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✓ Second product: Completion of ZIRCON Phase III trial of TLX250-CDx (renal cancer imaging)
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✓ Therapeutics: Launch ProstACT Phase III trial of TLX591 (prostate cancer therapy) in Australia, EU, US
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✓ Extend global reach: Asia, Latin America
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Molecularly Targeted Radiation.
Telix Pharmaceuticals Limited (ASX: TLX)
MTR: See It. Treat it.
Targeted radiation delivery
Unique cancer cell signature (target)
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Radioactive isotope
Targeting agent (a small molecule or antibody) binds selectively to a cancer cell
Systemically administered
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Imaging
TLX591-CDx[1] (Prostate cancer)
PET scanner
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68Ga, 89Zr (diagnostic isotopes) Enables PET images of cancer
TLX591
Therapy
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(Prostate cancer)
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177Lu, 131I, 225Ac
(therapeutic isotopes) Enables precise radiation delivery to the cancer
- Courtesy of Ammar Chaudhry MD, City of Hope, Duarte CA, USA. Telix Pharmaceuticals Limited (ASX: TLX)
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2020 Operating Summary
6
Response to the Impact of COVID-19
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Telix responded early in the pandemic to the long-term benefit of the Company
People
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Team retention, key executive and leadership hires completed
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Seamless transition to WFH[1] , maintained ability to collaborate and transact
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Pivoted to internal initiatives to strengthen the business – ERP, CRM, QMS[2]
Manufacturing and supply chain
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Qualified new vendors, logistics and contract manufacturers to build redundancy
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Nuclear medicine supply chain is highly distributed
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Clinical trials
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Key ZIRCON Phase III and IPAX-1 Phase I trials paused during Mar – Aug 2020
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~6 months behind schedule as a result
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Added sites to ZIRCON trial and strengthened clinical research relationships
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Work from home.
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Enterprise Resource Planning; Customer Relationship Management; Quality Management System. Telix Pharmaceuticals Limited (ASX: TLX)
Financial Dashboard
Increased expenditure reflective of preparation for commercial launch and pipeline R&D expansion
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FY 2020 FY 2020 FY 2020 FY 2020 Product-Related Cash Reserves R&D Investment Comprehensive Loss Revenue
+49%
+75%
+9%
+60%
FY 2019 FY 2019 $3.5M $44.6M
FY 2019 FY 2019 $21.2M $27.9M
Telix Pharmaceuticals Limited (ASX: TLX)
TLX591-CDx Prostate Cancer Imaging Kit Sales
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TLX591-CDx Kit Sales, FY 2020
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1,200 10,000
1,087
1,000 1,058
8,000
800
823
783 6,000
600
4,000
400
2,000
200
0 0
Q1 Q2 Q3 Q4
Imaging Kits Cumulative
Patient Doses
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COVID-19 had a material impact on TLX591-CDx prostate cancer imaging kit sales for 2020, particularly Q2 & Q3
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Telix delivered approximately 9,500 individual patient doses prepared from over 3,700 TLX591-CDx kits
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Telix received $3.9M in cash receipts from TLX591-CDx Kit sales in FY 2020, representing a 15% increase over prior year
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Average kit pricing remained stable on a territory-by-territory basis
Telix Pharmaceuticals Limited (ASX: TLX)
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Clinical Program Summary
10
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Deep Pipeline in Oncology, Rare Diseases
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| Phase I Phase II Phase III Commercial Targeting Molecule Cancer Cell Target Radioactive Isotope |
Phase I Phase II Phase III Commercial Targeting Molecule Cancer Cell Target Radioactive Isotope |
Phase I Phase II Phase III Commercial Targeting Molecule Cancer Cell Target Radioactive Isotope |
Phase I Phase II Phase III Commercial Targeting Molecule Cancer Cell Target Radioactive Isotope |
|---|---|---|---|
| Prostate 68Ga PSMA Small molecule 177Lu PSMA Antibody TLX591 (177Lu–rosopatamab) TLX591-CDx (68Ga-PSMA-11, 225Ac PSMA Antibody TLX592 (225Ac–RADmAb®) TLX599-CDx (99mTc-iPSMA) TLX591-Sx(68Ga-PSMA-IRDye) 99mTc PSMA Small molecule PSMA Small molecule 68Ga |
Illuccix®) |
Therapy Imaging Therapy (2nd Gen) Imaging / Surgery Imaging / Surgery |
|
| Kidney Antibody CA9 177Lu CA9 TLX250 (177Lu–girentuximab) TLX250-CDx (89Zr–girentuxim 89Zr Antibody |
ab) |
Therapy Imaging |
|
| Brain 18F LAT1 Small molecule 131I LAT1 Small molecule TLX101 (131I-IPA) TLX101-CDx(18F-FET) |
Imaging Therapy |
||
| BMC/RD1 TLX591 TLX66-CDx (99mTc-besilesomab, Scintimun®2) Antibody Antibody CD66 CD66 90Y 99mTc TLX66 (90Y-besilesomab) |
Therapy Imaging Imaging |
- Bone marrow conditioning / rare diseases.
Shaded arrows indicate expected development stage in the next 12 months.
- Scintimun[®] is a registered trademark of Curium Pharma.
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Prostate Cancer Program
12
US New Drug Application for TLX591-CDx (Illuccix[®] )
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New Drug Application submitted to the US FDA in September 2020[1]
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NDA accepted for filing in December 2020, thus proceeding to substantive review
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FDA mid-cycle review meeting scheduled for 2 March 2020
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No major issues identified following initial FDA assessment and no plan by FDA to conduct an advisory committee meeting
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Seeking an indication for the imaging of prostate cancer, from the early pre-treatment setting through to the later stages of advanced disease
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US commercial partners Cardinal Health and Pharmalogic provide access to ~95% of US hospital beds
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FDA approval expected second half of 2021[2]
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United States Food and Drug Administration.
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Subject to satisfying the necessary regulatory approvals.
Telix Pharmaceuticals Limited (ASX: TLX)
EU Marketing Authorisation Application for TLX591-CDx (Illuccix[®] )
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Marketing Authorisation Application submitted in April 2020
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Danish Medicines Agency serves as the reference Competent Authority for Telix’s submission
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14 EU member countries included in Telix’s submission, including the ‘EU5’ (+UK)
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Broad indication for the imaging of recurrent prostate cancer
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Temporary authorisations in some EU member states are expected ahead of full MAA approval
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✓ Czech Republic authorised STP[1] use of TLX591-CDx for a broad prostate cancer imaging indication (February 2021)
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Estimated EU MAA approval (country-by-country) Q3 2021[2]
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Specific Therapeutic Programme. https://www.sukl.eu/pharmaceutical-industry/related-information.
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Subject to satisfying the necessary regulatory approvals.
Telix Pharmaceuticals Limited (ASX: TLX)
Regulatory Submissions for TLX591-CDx (Illuccix[®] ) in Other Markets
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Telix is working towards a global product launch[1]
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Granted Priority Review status by Australian TGA in December 2020[2]
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TGA submission Q1 2021, with 150-day dossier review and approval
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New Drug Submission (NDS) filed with Health Canada in December 2020
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NDS accepted for review, anticipate Canadian approval with broad indication Q4 2021
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Swissmedic filing imminent
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Important jurisdiction for countries following EU/Swiss regulatory approvals
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Japanese ‘bridging’ study for TLX591-CDx will commence Q1 2021
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Data facilitates planning discussions with PMDA for approval in Japan[3]
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Subject to satisfying the necessary regulatory approvals in each jurisdiction.
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Pharmaceutical and Medical Device Agency.
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Therapeutic Goods Administration.
Telix Pharmaceuticals Limited (ASX: TLX)
ProstACT Phase III RCT[1] of TLX591 for Treatment of mCRPC[2]
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Pre-IND meeting with US FDA in November 2020 enabled ProstACT trial to be finalised[4]
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✓ International, multi-centre, Phase III RCT in ~390 patients with PSMA-expressing mCRPC, experiencing disease progression following prior treatment with a NAAD
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✓ Primary endpoint: rPFS[4 ]
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✓ Secondary endpoints include: OS, QoL, safety[5]
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✓ 2:1 randomisation and enrichment of study population, patient selection with TLX591-CDx
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Anticipate initiation of ProstACT in Australia in Q2 2021 and progressively add EU and US sites during H2 2021, subject to satisfying the requisite approvals
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Randomised controlled trial.
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Metastatic castration resistant prostate cancer.
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Radiographic progression-free survival.
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Overall survival; quality of life.
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Novel androgen axis drug Telix Pharmaceuticals Limited (ASX: TLX)
CUPID Phase I Trial of TLX592 for Treatment of Advanced PC[1]
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Targeted Alpha Therapy will be developed for patients failing[177] Lu therapy
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Actinium-225 ([225] Ac) is an alpha-emitting radioisotope
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✓ Very high energy, very short range, penetrates a few cells deep
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TLX592 employs TLX591 antibody, re-engineered to Telix’s RADmAb[®] format
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✓ Exhibits ideal attributes of antibodies (highly selective) and small molecules (rapidly cleared)
• Clinical opportunity
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✓ Early-stage metastatic disease with small disease burden (biochemical recurrence)
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✓ Late-stage PC no longer responding to[177] Lu-PSMA therapy (i.e. Telix & Novartis)
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CUPID is a first-in-human Phase I trial of TLX592
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CUPID =[64] Cu PSMA Imaging and (Bio)Distribution
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✓ Evaluating safety and tolerability, pharmacokinetics, biodistribution, radiation dosimetry of TLX592 in up to 15 patients with advanced prostate cancer – using[64] Cu to evaluate biodistribution / dosing in advance of commencing[225] Ac studies
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✓ Granted CTN[2 ] clearance by Australian TGA in November 2020, first patients in March
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Prostate cancer.
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Clinical trial notification.
Telix Pharmaceuticals Limited (ASX: TLX)
Summary – Telix’s Dual Approach for Prostate Cancer Therapy
TLX592 ([225] Ac-TLX592)
TLX591 ([177] Lu-rosopatamab)
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Traditional humanised antibody immunoconjugate Well-validated for beta emitters
Re-engineered antibody immunoconjugate (RADMab[®] ) Designed for delivering targeted alpha emitters
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Beta emitter ([177] Lu) suited to bulky metastatic disease
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Alpha emitter ([225] Ac) intended for
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Telix is building on a significant body of clinical data ✓ ~200 PC patients in five Phase I and II studies
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✓ Early-stage metastatic disease (e.g. BCR[2 ] )
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✓ Late-stage disease following[177] Lu-PSMA therapy
✓ Demonstrates significant therapeutic impact[1]
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Tagawa et al. Cancer 2019.
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Biochemical recurrence.
Telix Pharmaceuticals Limited (ASX: TLX)
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Renal Cancer Program
19
ZIRCON Phase III Trial of TLX250-CDx for Imaging of ccRCC[1 ]
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NCT03849118
NCT03849118
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International, multi-centre, Phase III trial in ~252 patients with an indeterminate renal mass suspicious of ccRCC
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✓ 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
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FDA approved Telix’s IND in January 2020 to enable ZIRCON to be conducted in US
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FDA subsequently granted Breakthrough Therapy (BT) designation for TLX250-CDx in July
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✓ Facilitates closer interaction with FDA and expedited approval process
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36 sites now participating, anticipate completion of patient recruitment mid-2021
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✓ US, Canada, Europe, Turkey, Australia
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Clear cell renal cell carcinoma.
Telix Pharmaceuticals Limited (ASX: TLX)
ZIRDAC-JP Phase I/II Bridging Trial of TLX250-CDx in Japan
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Zirconium Dosing and Comparison in Japan
- Japanese, multi-centre, Phase I/II trial in ~40 patients with an indeterminate renal mass suspicious for ccRCC
• Primary endpoints NCT03849118 NCT03849118
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✓ Phase I – Safety and tolerability
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✓ Phase II – 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
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Similar design to global Phase III ZIRCON trial
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Carefully designed in consultation with Japanese PMDA[1] to potentially bridge to the ZIRCON trial
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Pk/Pd[2] Phase I in 6 patients completed
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Phase II in planning, potential to include Chinese patients to expand Asian utility[3]
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Subject to satisfying the necessary regulatory approvals.
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Pharmacokinetics / pharmacodynamics.
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Pharmaceutical and Medical Devices Agency.
Telix Pharmaceuticals Limited (ASX: TLX)
STARLITE Phase II Trial of TLX250 for Treatment of ccRCC
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TLX250 in combination with immunotherapy
- Phase II trial of TLX250 plus nivolumab in ~30 patients with ccRCC who have progressed following prior immunotherapy
NCT03849118 • NCT03849118 Primary endpoint
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✓ To determine the efficacy of combination therapy with[177] Lu-girentuximab (TLX250) as assessed by objective response rate
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STARLITE program intended to be conducted at two US institutions was significantly impacted by COVID-19 and diversion of clinical research personnel away from usual research activities
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FDA Investigational New Drug Application (IND) filing in progress
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Patient recruitment expected to commence May 2021[1]
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- Subject to satisfying the necessary regulatory approvals.
Telix Pharmaceuticals Limited (ASX: TLX)
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Glioblastoma Program
23
IPAX-I Phase I/II Trial of TLX101 for Treatment of GBM[1]
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TLX101 in combination with EBRT[2]
- Multi-centre Phase I/II trial of TLX101 in combination with EBRT in up to 44 patients with recurrent GBM
NCT03849118 NCT03849118 ✓ Primary endpoint: Safety and tolerability
✓ Secondary endpoints include: MTD[3] , efficacy, dosimetry
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Promising initial data from lowest dose cohorts presented in Dec 2020
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✓ Initial treatment cohort, treated in single and triple fractions
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✓ Treatment well tolerated, predominantly grade 1 – 2 adverse events
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✓ Clear evidence of anti-tumour effect
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Intend to accelerate dosing to determine optimal dose, to support consultation with regulatory authorities and pivotal trial design
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✓ Expand TLX101 program to US patients, IND in preparation
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Baseline PET scan
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Day 45 PET scan post TLX101 therapy
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Maximum tolerated dose.
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External beam radiation therapy.
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.
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Telix Pharmaceuticals Limited (ASX: TLX)
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Glioblastoma Multiforme.
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Bone Marrow Conditioning / Rare Diseases Program
25
TRALA Trial of[90] Y-besilesomab (TLX66) in SALA[1 ]
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Targeted Radiotherapy for Amyloid Light Chain Amyloidosis (TRALA)[2]
• SALA
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✓ Rare disease with a poor prognosis (median survival ~11 months if untreated)
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NCT03849118
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NCT03849118 ✓ Plasma cells in the bone marrow produce abnormal protein called ‘amyloid’ which accumulates in the organs and causes them to fail
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✓ Prevalence of ~30,000 (US) and 45,000 (EU) patients, ~US$600M TAM[3] in US and ‘EU5’
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Current standard of care comprises induction therapy (cyclophosphamide, bortezomib, dexamethasone) plus high dose melphalan BMC[4] , followed by HSCT[5, 6]
• TRALA study
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✓ Primary endpoint: Safety and toxicity of[90] Y-besilesomab as the sole BMC regime for autologous HSCT in patients with SALA
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✓ Study complete, data readout imminent
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Faulty plasma cells
Free antibody light chain
Amyloid protein accumulates in organs
Organ failure, death
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Systemic amyloid light chain amyloidosis.
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https://www.clinicaltrialsregister.eu/ctr-search/trial/2015-002231-18/GB
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Total addressable market.
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Bone marrow conditioning.
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Hematopoietic stem cell transplant.
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Venner C, et al. Blood. (2012) 119 (19): 4387–4390.
Telix Pharmaceuticals Limited (ASX: TLX)
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Partnerships and Transactions
27
Serving Patients Through Collaboration
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Advanced prostate imaging to guide radiation therapy
Telix PET tracers for treatment planning, automated analysis, AI capabilities within Varian’s radiation treatment planning platforms
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Imaging and Robotics in Surgery (IRiS) Alliance
Telix dual modality PET-optical tracers for pre-operative imaging and intra-operative optical guidance
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Improved treatment for high-risk or recurrent urologic cancer
Telix PET tracers to guide biologically-guided radiation therapy (BgRT) in prostate and kidney cancers
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Enabling cell & gene therapies
MTR has a key role in realising the efficacy of cell & gene therapies, and broadening potential applications of bone marrow transplantation in cancer and immunologic diseases
Telix Pharmaceuticals Limited (ASX: TLX)
Acquisition of TheraPharm GmbH
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Broadens Telix’s MTR pipeline into hematologic oncology (blood cancers), bone marrow transplantation, high value rare diseases
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Acquired TheraPharm for €20.2M (~$32.7M) comprising upfront, earn-out and royalty payments
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Key asset is a radiolabeled antibody (besilesomab) targeting CD66 expressed by white blood cells
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Diagnostic imaging product Scintimun[®] ([99m] Tc-besilesomab) is already approved in EU for imaging suspected bone infection (osteomyelitis)
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Therapeutic product[90] Y-besilesomab for bone marrow conditioning (BMC) prior to hematopoietic stem cell transplantation (HSCT)
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✓ Excellent clinical safety and efficacy data from phase I / II clinical studies[1]
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✓ Granted orphan drug designation in Europe
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✓ Significant potential for SALA , multiple myeloma, leukemia
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Bone marrow containing tumour cells before[90] Y-anti-CD66-MTR.
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Bone marrow 12 days after treatment with a single dose of[90] Y-anti-CD66MTR. Bone marrow and tumour cells destroyed without additional chemotherapy.
- Orchard K et al. Presented at the 35[th] International Conference on Advances in the Application of Monoclonal Antibodies in Clinical Oncology, June 2018. Telix Pharmaceuticals Limited (ASX: TLX)
Pipeline Expansion Through Collaborative R&D: Examples
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TLX599-CDx ([99m] Tc-iPSMA)
Chemistry for[99m] Tc-PSMA for ‘rest of world’ PSMA imaging where PET is not readily available
TLX591-Sx ([68] Ga-PSMA-IRDye)
Dual labelled PET-optical tracer for image-guided surgery.[1 ] Clinical applications being developed in the IRiS Alliance
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68 Ga-PSMA-914 PET/CT showing primary prostate cancer (a, arrow). Robotic prostatectomy with fluorescent guidance, with primary prostate cancer visualized by green fluorescence signal and delineated from surrounding tissue (b). Consecutive fluorescence detection after prostatectomy (c) confirmed intraoperative findings of tumour-specific PET-optical tracer enrichment (d) and high contrast to surrounding healthy tissues (e).
- Eder AC et al. Eur J Nucl Med Mol Imaging (2021).
Telix Pharmaceuticals Limited (ASX: TLX)
Strategic Partnership with China Grand Pharma
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Partnership is central to Telix’s objective of expanding its Asian commercial presence
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Partnership represents up to $400M+ in value to Telix, plus royalties on product sales over the partnership life time
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Grants exclusive rights to a portion of Telix’s diagnostic and therapeutic MTR products for Greater China[1 ]
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Provided Telix an immediate cash injection of US$50M (~$69M)
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CGP is an excellent Greater China partner for Telix
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✓ Established track record in oncology product development
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✓ Experience in developing therapeutic radioactive products (Sirtex)
• Have quickly ‘operationalised’ the partnership
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✓ Effective cross-functional team has commenced extensive clinical and regulatory work
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Mainland China, Hong Kong SAR, Macau SAR, Taiwan.
Telix Pharmaceuticals Limited (ASX: TLX)
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Looking Ahead
32
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Three Major Value Events Anticipated in 2021
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Commence ProstACT Complete ZIRCON Launch Illuccix [®]
ZIRCON
Commence Phase III therapy trial Complete Phase III trial Regulatory approval
Australia initially (H1) BLA [(1) ] preparation Commercial launch
EU and US (H2) Second commercial product First commercial revenue
Stakeholder Focus:
Become patient centric in everything we do. Become a revenue generating company.
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- Biologic license application.
Telix Pharmaceuticals Limited (ASX: TLX)
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telixpharma.com
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