Telix Pharmaceuticals Limited - Shareholder Update - Year Ended 31 December 2020 26 February 2021 - Telix ...
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Telix Pharmaceuticals Limited
Shareholder Update – Year Ended 31 December 2020
26 February 2021
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. None of the products or potential products described in this presentation have received a marketing authorisation in any jurisdiction. Telix Pharmaceuticals Limited (ASX: TLX) 2
Contents 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) 3
Telix: A Snapshot
Late stage MTR1 product portfolio
✓ Oncology with focus on prostate, renal, glioblastoma, hematologic cancers
✓ Immunology applications and high value rare diseases
Major milestones achieved during 2020…despite COVID-19
✓ Illuccix® (prostate cancer imaging):
• Regulatory filings in US, EU, Canada, Australia
• Commercial distribution agreements in US (Cardinal Health and Pharmalogic) and major EU & APAC territories
✓ Licensed production facility acquired in Seneffe, Belgium from Eckert & Ziegler AG
✓ China Grand Pharma transaction: Up to $400M+ value, delivers long-term clinical & commercial partner for Greater China region
✓ 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
✓ Illuccix® : Regulatory approval and commercial launch in US, EU, Canada, Australia. First commercial product revenue
✓ Second product: Completion of ZIRCON Phase III trial of TLX250-CDx (renal cancer imaging)
✓ Therapeutics: Launch ProstACT Phase III trial of TLX591 (prostate cancer therapy) in Australia, EU, US
✓ Extend global reach: Asia, Latin America
1. Molecularly Targeted Radiation.
Telix Pharmaceuticals Limited (ASX: TLX) 4
MTR: See It. Treat it.
Targeted radiation delivery Systemically administered Imaging PET scanner TLX591-CDx1
(Prostate cancer)
Unique cancer cell
signature (target)
68Ga, 89Zr
(diagnostic isotopes)
Enables PET
images of cancer
Therapy TLX591
(Prostate cancer)
Radioactive
isotope
Targeting agent
177Lu, 131I, 225Ac
(a small molecule or antibody)
binds selectively to a (therapeutic isotopes)
cancer cell Enables precise radiation
delivery to the cancer
1. Courtesy of Ammar Chaudhry MD, City of Hope, Duarte CA, USA.
Telix Pharmaceuticals Limited (ASX: TLX) 5
2020 Operating Summary
6
Response to the Impact of COVID-19 Telix responded early in the pandemic to the long-term benefit of the Company People • Team retention, key executive and leadership hires completed • Seamless transition to WFH1, maintained ability to collaborate and transact • Pivoted to internal initiatives to strengthen the business – ERP, CRM, QMS2 Manufacturing and supply chain • Qualified new vendors, logistics and contract manufacturers to build redundancy • Nuclear medicine supply chain is highly distributed Clinical trials • Key ZIRCON Phase III and IPAX-1 Phase I trials paused during Mar – Aug 2020 • ~6 months behind schedule as a result • Added sites to ZIRCON trial and strengthened clinical research relationships 1. Work from home. 2. Enterprise Resource Planning; Customer Relationship Management; Quality Management System. Telix Pharmaceuticals Limited (ASX: TLX) 7
Financial Dashboard
Increased expenditure reflective of preparation for commercial launch and pipeline R&D expansion
FY 2020 FY 2020 FY 2020 FY 2020
Product-Related Cash Reserves R&D Investment Comprehensive Loss
Revenue
+49% +75% +9% +60%
$5.2M $77.9M $23.1M $44.5M
FY 2019 FY 2019 FY 2019 FY 2019
$3.5M $44.6M $21.2M $27.9M
Telix Pharmaceuticals Limited (ASX: TLX) 8
TLX591-CDx Prostate Cancer Imaging Kit Sales
TLX591-CDx Kit Sales, FY 2020
1,200 10,000 • COVID-19 had a material impact on
TLX591-CDx prostate cancer imaging kit
1,087 sales for 2020, particularly Q2 & Q3
1,000 1,058
8,000
• Telix delivered approximately 9,500
800 individual patient doses prepared from
823
783 6,000 over 3,700 TLX591-CDx kits
600 • Telix received $3.9M in cash receipts
from TLX591-CDx Kit sales in FY 2020,
4,000
representing a 15% increase over prior
400
year
2,000 • Average kit pricing remained stable on
200
a territory-by-territory basis
0 0
Q1 Q2 Q3 Q4
Imaging Kits Cumulative
Patient Doses
Telix Pharmaceuticals Limited (ASX: TLX) 9
Clinical Program Summary
10Deep Pipeline in Oncology, Rare Diseases
Targeting Cancer Cell Radioactive
Molecule Target Isotope Phase I Phase II Phase III Commercial
Small 68Ga TLX591-CDx (68Ga-PSMA-11, Illuccix®)
PSMA Imaging
molecule
177Lu
Antibody PSMA TLX591 (177Lu–rosopatamab) Therapy
Prostate
225Ac
Antibody PSMA TLX592 (225Ac–RADmAb®) Therapy (2nd Gen)
Small
99mTc TLX599-CDx (99mTc-iPSMA)
molecule PSMA Imaging / Surgery
Small 68Ga
molecule PSMA TLX591-Sx (68Ga-PSMA-IRDye) Imaging / Surgery
89Zr
Kidney
Antibody CA9 TLX250-CDx (89Zr–girentuximab) Imaging
Antibody 177Lu TLX250 (177Lu–girentuximab)
CA9 Therapy
Small 18F
LAT1 TLX101-CDx (18F-FET) Imaging
Brain
molecule
Small LAT1 131I TLX101 (131I-IPA) Therapy
molecule
BMC/RD1
Antibody CD66 99mTc TLX66-CDx (99mTc-besilesomab, Scintimun®2) Imaging
Antibody CD66 90Y TLX66 (90Y-besilesomab) Therapy
TLX591
1. Bone marrow conditioning / rare diseases. Shaded arrows indicate expected development stage in the next 12 months.
2. Scintimun® is a registered trademark of Curium Pharma. 11Prostate Cancer Program
12US New Drug Application for TLX591-CDx (Illuccix®) New Drug Application submitted to the US FDA in September 20201 • NDA accepted for filing in December 2020, thus proceeding to substantive review • FDA mid-cycle review meeting scheduled for 2 March 2020 • No major issues identified following initial FDA assessment and no plan by FDA to conduct an advisory committee meeting • Seeking an indication for the imaging of prostate cancer, from the early pre-treatment setting through to the later stages of advanced disease • US commercial partners Cardinal Health and Pharmalogic provide access to ~95% of US hospital beds • FDA approval expected second half of 20212 1. United States Food and Drug Administration. 2. Subject to satisfying the necessary regulatory approvals. Telix Pharmaceuticals Limited (ASX: TLX) 13
EU Marketing Authorisation Application for TLX591-CDx (Illuccix®)
Marketing Authorisation Application submitted in April 2020
• Danish Medicines Agency serves as the reference Competent Authority for Telix’s
submission
• 14 EU member countries included in Telix’s submission, including the ‘EU5’ (+UK)
• Broad indication for the imaging of recurrent prostate cancer
• Temporary authorisations in some EU member states are expected ahead of full MAA
approval
✓ Czech Republic authorised STP1 use of TLX591-CDx for a broad prostate cancer
imaging indication (February 2021)
• Estimated EU MAA approval (country-by-country) Q3 20212
1. Specific Therapeutic Programme. https://www.sukl.eu/pharmaceutical-industry/related-information.
2. Subject to satisfying the necessary regulatory approvals.
Telix Pharmaceuticals Limited (ASX: TLX) 14Regulatory Submissions for TLX591-CDx (Illuccix®) in Other Markets
Telix is working towards a global product launch1
• Granted Priority Review status by Australian TGA in December 20202
• TGA submission Q1 2021, with 150-day dossier review and approval
• New Drug Submission (NDS) filed with Health Canada in December 2020
• NDS accepted for review, anticipate Canadian approval with broad indication Q4 2021
• Swissmedic filing imminent
• Important jurisdiction for countries following EU/Swiss regulatory approvals
• Japanese ‘bridging’ study for TLX591-CDx will commence Q1 2021
• Data facilitates planning discussions with PMDA for approval in Japan3
1. Subject to satisfying the necessary regulatory approvals in each jurisdiction. 3. Pharmaceutical and Medical Device Agency.
2. Therapeutic Goods Administration.
Telix Pharmaceuticals Limited (ASX: TLX) 15ProstACT Phase III RCT1 of TLX591 for Treatment of mCRPC2
• Pre-IND meeting with US FDA in November 2020 enabled ProstACT trial to be finalised4
✓ International, multi-centre, Phase III RCT in ~390 patients with PSMA-expressing mCRPC, experiencing disease
progression following prior treatment with a NAAD
✓ Primary endpoint: rPFS4
✓ Secondary endpoints include: OS, QoL, safety5
✓ 2:1 randomisation and enrichment of study population, patient selection with TLX591-CDx
• 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
1. Randomised controlled trial. 4. Radiographic progression-free survival.
2. Metastatic castration resistant prostate cancer. 5. Overall survival; quality of life.
3. Novel androgen axis drug
Telix Pharmaceuticals Limited (ASX: TLX) 16CUPID Phase I Trial of TLX592 for Treatment of Advanced PC1
Targeted Alpha Therapy will be developed for patients failing 177Lu therapy
• Actinium-225 (225Ac) is an alpha-emitting radioisotope
✓ Very high energy, very short range, penetrates a few cells deep
• TLX592 employs TLX591 antibody, re-engineered to Telix’s RADmAb® format
✓ Exhibits ideal attributes of antibodies (highly selective) and small molecules (rapidly cleared)
• Clinical opportunity
✓ Early-stage metastatic disease with small disease burden (biochemical recurrence)
✓ Late-stage PC no longer responding to 177Lu-PSMA therapy (i.e. Telix & Novartis)
CUPID is a first-in-human Phase I trial of TLX592
• CUPID = 64Cu PSMA Imaging and (Bio)Distribution
✓ Evaluating safety and tolerability, pharmacokinetics, biodistribution, radiation dosimetry of
TLX592 in up to 15 patients with advanced prostate cancer – using 64Cu to evaluate
biodistribution / dosing in advance of commencing 225Ac studies
✓ Granted CTN2 clearance by Australian TGA in November 2020, first patients in March
1. Prostate cancer.
2. Clinical trial notification.
Telix Pharmaceuticals Limited (ASX: TLX) 17Summary – Telix’s Dual Approach for Prostate Cancer Therapy
TLX591 (177Lu-rosopatamab) TLX592 (225Ac-TLX592)
Traditional humanised antibody immunoconjugate Re-engineered antibody immunoconjugate (RADMab®)
Well-validated for beta emitters Designed for delivering targeted alpha emitters
• Beta emitter (177Lu) suited to bulky metastatic disease • Alpha emitter (225Ac) intended for
• Telix is building on a significant body of clinical data ✓ Early-stage metastatic disease (e.g. BCR2 )
✓ ~200 PC patients in five Phase I and II studies ✓ Late-stage disease following 177Lu-PSMA therapy
✓ Demonstrates significant therapeutic impact 1
1. Tagawa et al. Cancer 2019. 2. Biochemical recurrence.
Telix Pharmaceuticals Limited (ASX: TLX) 18Renal Cancer Program
19ZIRCON Phase III Trial of TLX250-CDx for Imaging of ccRCC1
NCT03849118
NCT03849118
• 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
• FDA approved Telix’s IND in January 2020 to enable ZIRCON to be conducted in US
• FDA subsequently granted Breakthrough Therapy (BT) designation for TLX250-CDx in July
✓ Facilitates closer interaction with FDA and expedited approval process
• 36 sites now participating, anticipate completion of patient recruitment mid-2021
✓ US, Canada, Europe, Turkey, Australia
1. Clear cell renal cell carcinoma.
Telix Pharmaceuticals Limited (ASX: TLX) 20ZIRDAC-JP Phase I/II Bridging Trial of TLX250-CDx in Japan
Zirconium Dosing and Comparison in Japan
• Japanese, multi-centre, Phase I/II trial in ~40 patients with an indeterminate renal
mass suspicious for ccRCC
•NCT03849118
Primary endpoints
NCT03849118
NCT03849118
✓ Phase I – Safety and tolerability
✓ 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
• Similar design to global Phase III ZIRCON trial
• Carefully designed in consultation with Japanese PMDA1 to potentially bridge
to the ZIRCON trial
• Pk/Pd2 Phase I in 6 patients completed
• Phase II in planning, potential to include Chinese patients to expand Asian utility3
1. Pharmaceutical and Medical Devices Agency. 3. Subject to satisfying the necessary regulatory approvals.
2. Pharmacokinetics / pharmacodynamics.
Telix Pharmaceuticals Limited (ASX: TLX) 21STARLITE Phase II Trial of TLX250 for Treatment of ccRCC
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
✓ To determine the efficacy of combination therapy with 177Lu-girentuximab (TLX250) as
assessed by objective response rate
• 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
• FDA Investigational New Drug Application (IND) filing in progress
• Patient recruitment expected to commence May 20211
1. Subject to satisfying the necessary regulatory approvals.
Telix Pharmaceuticals Limited (ASX: TLX) 22Glioblastoma Program
23IPAX-I Phase I/II Trial of TLX101 for Treatment of GBM1
TLX101 in combination with EBRT2
• Multi-centre Phase I/II trial of TLX101 in combination with EBRT in up to 44 patients
with recurrent GBM
NCT03849118
✓ Primary endpoint: Safety and tolerability
NCT03849118
✓ Secondary endpoints include: MTD3, efficacy, dosimetry
• Promising initial data from lowest dose cohorts presented in Dec 2020
✓ Initial treatment cohort, treated in single and triple fractions Baseline PET scan
✓ Treatment well tolerated, predominantly grade 1 – 2 adverse events
✓ Clear evidence of anti-tumour effect
• Intend to accelerate dosing to determine optimal dose, to support consultation with
regulatory authorities and pivotal trial design
✓ Expand TLX101 program to US patients, IND in preparation
Day 45 PET scan post
TLX101 therapy
1. Glioblastoma Multiforme. 3. Maximum tolerated dose.
2. External beam radiation therapy.
.
Telix Pharmaceuticals Limited (ASX: TLX) 24Bone Marrow Conditioning /
Rare Diseases Program
25TRALA Trial of 90Y-besilesomab (TLX66) in SALA1
Targeted Radiotherapy for Amyloid Light Chain Amyloidosis (TRALA)2
• SALA
Faulty
✓ Rare disease with a poor prognosis (median survival ~11 months if untreated) plasma cells
NCT03849118
✓ Plasma cells in the bone marrow produce abnormal protein called ‘amyloid’ which accumulates
NCT03849118
in the organs and causes them to fail
✓ Prevalence of ~30,000 (US) and 45,000 (EU) patients, ~US$600M TAM3 in US and ‘EU5’
Free antibody
• Current standard of care comprises induction therapy (cyclophosphamide, bortezomib, light chain
dexamethasone) plus high dose melphalan BMC4, followed by HSCT5, 6
• TRALA study
Amyloid
✓ Primary endpoint: Safety and toxicity of 90Y-besilesomab as the sole BMC regime for autologous protein
HSCT in patients with SALA accumulates
in organs
✓ Study complete, data readout imminent
Organ failure, death
1. Systemic amyloid light chain amyloidosis. 4. Bone marrow conditioning.
2. https://www.clinicaltrialsregister.eu/ctr-search/trial/2015-002231-18/GB 5. Hematopoietic stem cell transplant.
3. Total addressable market. 6. Venner C, et al. Blood. (2012) 119 (19): 4387–4390.
Telix Pharmaceuticals Limited (ASX: TLX) 26Partnerships and Transactions
27Serving Patients Through Collaboration
Advanced prostate imaging Improved treatment for
to guide radiation therapy high-risk or recurrent
Telix PET tracers for treatment urologic cancer
planning, automated analysis, Telix PET tracers to guide
AI capabilities within Varian’s biologically-guided radiation
radiation treatment planning therapy (BgRT) in prostate
platforms and kidney cancers
Imaging and Robotics in Surgery
Enabling cell & gene therapies
(IRiS) Alliance
MTR has a key role in realising the efficacy of cell &
Telix dual modality PET-optical tracers for
gene therapies, and broadening potential
pre-operative imaging and intra-operative
applications of bone marrow transplantation in
optical guidance
cancer and immunologic diseases
Telix Pharmaceuticals Limited (ASX: TLX) 28Acquisition of TheraPharm GmbH
• Broadens Telix’s MTR pipeline into hematologic oncology (blood cancers), bone
marrow transplantation, high value rare diseases
• Acquired TheraPharm for €20.2M (~$32.7M) comprising upfront, earn-out and
royalty payments
• Key asset is a radiolabeled antibody (besilesomab) targeting CD66 expressed by
Bone marrow containing tumour cells
white blood cells before 90Y-anti-CD66-MTR.
• Diagnostic imaging product Scintimun® (99mTc-besilesomab) is already approved
in EU for imaging suspected bone infection (osteomyelitis)
• Therapeutic product 90Y-besilesomab for bone marrow conditioning (BMC) prior
to hematopoietic stem cell transplantation (HSCT)
✓ Excellent clinical safety and efficacy data from phase I / II clinical studies1
✓ Granted orphan drug designation in Europe Bone marrow 12 days after treatment
with a single dose of 90Y-anti-CD66-
✓ Significant potential for SALA, multiple myeloma, leukemia MTR. Bone marrow and tumour cells
destroyed without additional
chemotherapy.
1. Orchard K et al. Presented at the 35th International Conference on Advances in the Application of Monoclonal Antibodies in Clinical Oncology, June 2018.
Telix Pharmaceuticals Limited (ASX: TLX) 29Pipeline Expansion Through Collaborative R&D: Examples
TLX599-CDx (99mTc-iPSMA) TLX591-Sx (68Ga-PSMA-IRDye)
Chemistry for 99mTc-PSMA for ‘rest of world’ PSMA imaging where Dual labelled PET-optical tracer for image-guided surgery.1 Clinical
PET is not readily available applications being developed in the IRiS Alliance
68Ga-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).
1. Eder AC et al. Eur J Nucl Med Mol Imaging (2021).
Telix Pharmaceuticals Limited (ASX: TLX) 30Strategic Partnership with China Grand Pharma
• Partnership is central to Telix’s objective of expanding its Asian commercial
presence
• Partnership represents up to $400M+ in value to Telix, plus royalties on product
sales over the partnership life time
• Grants exclusive rights to a portion of Telix’s diagnostic and therapeutic MTR
products for Greater China1
• Provided Telix an immediate cash injection of US$50M (~$69M)
• CGP is an excellent Greater China partner for Telix
✓ Established track record in oncology product development
✓ Experience in developing therapeutic radioactive products (Sirtex)
• Have quickly ‘operationalised’ the partnership
✓ Effective cross-functional team has commenced extensive clinical and regulatory work
1. Mainland China, Hong Kong SAR, Macau SAR, Taiwan.
Telix Pharmaceuticals Limited (ASX: TLX) 31Looking Ahead
32Three Major Value Events Anticipated in 2021
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.
1. Biologic license application.
Telix Pharmaceuticals Limited (ASX: TLX) 33telixpharma.com
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