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Telix Pharmaceuticals Ltd — Investor Presentation 2018
May 30, 2018
31324_rns_2018-05-30_996ae0e9-b373-4290-93ed-654e2f5c4b12.pdf
Investor Presentation
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Telix Pharmaceuticals Limited (ASX:TLX)
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Rapid Insights Conference May, 2018
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Notices
The information contained in the 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. 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 contains 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 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.
2
Company overview
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Founded November 2015
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Melbourne-based with team in Europe, US and Japan
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IPO, listed on the ASX in November 2017
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Raised a total of AUD $58.5m (Seed + IPO)
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Fully funded for 24 months
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Mission : to become a leading oncology company in the field of “molecularly-targeted radiation” (MTR)
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Two major disease focus areas:
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➢ Neuro-oncology (glioblastoma)
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➢ Urology (renal / prostate)
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Market metrics
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$0.68 (25[th] of May)
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Mkt. Cap. A$135m
Disease Focus Oncology Clinical Stage Phase I - III Shares on Issue 197,437,500 Options on Issue 6,624,000 Cash on Hand AUD ~$45m Symbol TLX
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November ‘17 IPO at $0.65
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Major investors : Fidelity, Acorn Capital, Viburnum, UV Cap
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• Shareholder base is mostly sophisticated/institutional
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Our business : Molecularly-Targeted Radiation (MTR)
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MTR works by chemically attaching radioactive isotopes to targeting molecules that are very specific for cancer cells. At low doses, this enables the location of the cancer cells to be pinpointed using PET imaging. At high doses the patient is very effectively treated.
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Positron Emission Tomography – “PET”
See it, treat it…
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Telix develops drugs that deliver targeted radiation directly to cancer. :
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At low doses, the patient can be imaged
TLX591 (Prostate) TLX250 (Kidney) TXL-101 (Brain)
- At high doses, the patient is treated
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How does Telix fit into cancer care?
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CANCER CARE
Ancient times - 1890’s - 1940’s - 1990’s - 1990’s -
present present present present present
SURGERY
RADIOTHERAPY
CHEMOTHERAPY
TARGETED DRUGS IMMNOTHERAPY
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Telix is modernising 1950’s radiation oncology
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Stanford University, 1950s
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Advanced image guidance and treatment planning has improved performance but radiation oncology is still fundamentally 1950s technology
Clinac® IX by Varian Medical Systems
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A new weapon in the fight against cancer …
External Beam Therapy (EBT)
- An fundamental part of cancer treatment
• “Externally Targeted” from a machine (a linear accelerator) •
- ~Multi-$Bn global market. Decent procedure growth, but linear accelerator growth is very low. Leading companies are in M&A mode
Molecularly-Targeted Radiation (MTR)
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Deliver radiation only to areas where disease target is expressed
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• Injected, “Molecularly Targeted” •
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Able to hit very small tumors not able to be seen with standard imaging and therapy systems
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Far less collateral damage to healthy tissue. Well tolerated by patients
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Pipeline development over the next 24 months
| Pipeline development over the next 24 months | 4 months | ||
|---|---|---|---|
| 10 Kidney Prostate Brain Phase I Phase II Phase III Commercial TLX250 (Girentuximab) TLX591 TLX591-Cdx (PSMA-11) TLX101 TLX101-Cdx – Research Use Only TLX250-Cdx (Girentuximab) 177Lu CA-IX Antibody Isotope Target Agent 89Zr CA-IX Antibody 177Lu PSMA Antibody 68Ga PSMA Small Molecule 131I LAT-1 Small Molecule 124I LAT-1 Small Molecule Therapy Imaging Therapy Imaging Therapy Imaging Shaded arrows indicate what the company will achieve with IPO proceeds |
Phase II | Phase III | Commercial |
| b) ximab) |
Therapy | Imaging | |
| 1) | Therapy | Imaging | |
| ch Use Only | Therapy Imaging |
Substantial clinical evidence
170 metastatic prostate cancer patients have demonstrated a 30+ month survival benefit
40 patients with advanced, progressive metastatic renal cancer achieved a median progression-free survival of 10 months
Under compassionate use in Germany, glioblastoma patients treated with TLX101 have lived 30 or 40 months instead of 6 months
Telix is developing an imaging agent that will transform the way that 3 million men live with their prostate cancer
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Market opportunity
All of TLX’s current valuation is here…
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Therapy Imaging is here… •
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• TLX250 imaging is a $200m revenue opportunity in Potential to treat 50,000 patients (US/EU5)
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• its own right. We expect to complete Phase III Follow-on therapy to immunotherapy
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• development in 2019 May enhance efficacy of immunotherapy drugs •
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• $400-500m addressable market Very low competition with high unmet need • Prostate cancer is a multi-$Bn market that is moving • Our prostate imaging program for TLX591
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extremely fast
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• (partnered with ANMI) will become commercial in Telix has the clinical data to support early intervention the US mid-2018 as a “kit” for dose preparation
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and the IP position to protect it
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• 90% of glioblastoma patients relapse and the •
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“salvage” therapy market is a $200-300m opportunity Clinical solutions exist for glioblastoma imaging
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• Orphan drug designation means faster development This is all multiplier upside that is about to go live…
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TLX250 imaging is a $200m revenue opportunity in its own right. We expect to complete Phase III development in 2019
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• Very low competition with high unmet need
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Our prostate imaging program for TLX591 (partnered with ANMI) will become commercial in the US mid-2018 as a “kit” for dose preparation
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Current program status
TLX250 (renal cancer)
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Imaging : Phase III bridging study – first patient in any day. Phase III imaging IMPD (Europe) filed late June / early July
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Therapy : Phase II study (US) IND in preparation
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TLX591 (prostate cancer)
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Imaging : Drug Master File in FDA review (expected completion endJune or early July). Will then start kit sales in the US
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Therapy : drug product in manufacturing for early Q19 start
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TLX101 (brain cancer)
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Therapy : Manufacturing complete, Phase I/II IMPD (EU) will be filed in the next couple of weeks. Also preparing to add Australian sites
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A major inflection in Q3 : getting to first revenues…
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Generator
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68Ga is produced from a “generator” – a self-contained unit that contains enough radioactivity to make 5-10 patient doses each day. Each generator lasts a few months before it has to be replaced
What is an Imaging “Kit”?
Kit
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Kit : A package containing all the components necessary to attach the radioactivity to a targeting agent (PSMA). The kit is used at room temperature and takes a few minutes to prepare an injection-ready dose. In the industry is colloquially known as a “shake and shoot” kit PET Scanner
Injectable
The end product is a syringe of radiolabelled imaging agent that is ready to inject into the patient. An hour after injection, the patient is imaged in a PET scanner
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A lot of watchful waiting means a big commercial opportunity for prostate imaging
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Salivary and
D
lacrimal gland
uptake is
Imaging matters … and PSMA imaging is very sensitive
normal
A B C
It is possible to image disease with
PSMA-11, even at very low PSA levels Slight liver High
kidney
(= low tumour burden). uptake
uptake
The three panels A)-C) illustrate how EVERYWHERE
PSMA imaging avidity changes as a
function of PSA levels (from low to
high PSA). All of these patients are
imaged post-prostatectomy. [1]
Cancer
A few highly vivid tumours are marked
for noting (red arrows)
Bladder
(excreted
tracer/urine)
Tumour load Low Medium High
PSA 4.8ng/ml 454ng/ml 2860ng/ml
D) A typical PSMA-11 projection image
illustrating the biodistribution of the tracer [2]
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1) Adapted from : Oncotarget. 2017; 8:55094-55103. https://doi.org/10.18632/oncotarget.19049
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1) Adapted from : Oncotarget. 2017; 8:55094-55103. https://doi.org/10.18632/oncotarget.19049 2) Image from : J Nucl Med January 1, 2017 vol. 58 no. 1 81-84, teaching resource
And can potentially transform therapy… (castration isn’t nice)
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Before After
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A potential game-changer in the management of prostate cancer…
Our opportunity is to induce androgen deprivation for a short time (short-term hormone use) to drive PSMA expression and then WHAM … hit cancer that has been sensitised to PSMA therapy.
Androgen Deprivation
$6Bn business
(and then maybe stop taking hormone therapy, at least for a while)
PSMA Expression
The next $6Bn business
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Management team
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Dr. Christian Behrenbruch (Co-Founder, MD and CEO)
Chris has 20 years of healthcare executive experience as CEO, Mirada Solutions, CTI Molecular Imaging (now Siemens Healthcare), Fibron Technologies and ImaginAb, Inc., former Director of Momentum Biosciences LLC, Siemens Molecular Imaging Ltd, Radius Health Ltd (now Adaptix) and was the former Chairman of Cell Therapies P/L.. He is currently a non-executive director of Factor Therapeutics (ASX:FTT). Christian holds a D.Phil (PhD) in biomedical engineering from the University of Oxford, an executive MBA (TRIUM Program) and a Juris Doctor (Law) from the University of Melbourne.
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Dr. Andreas Kluge (Co-Founder and Chief Medical Officer)
Andreas has 20 years of clinical research and development experience, including as Founder, General Manager and Medical Director for ABX-CRO GmbH, a full service CRO for phase I-III biological, radiopharmaceutical and anticancer trials based in Dresden, Germany. Andreas is a registered physician and holds a doctorate in Medicine from the Free University of Berlin.
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Mr. Douglas Cubbin (CFO)
Doug has spent the last eleven years in CFO, COO, commercial and business development roles in companies in the nuclear medicine sector. Prior to that Doug, was the Group CFO of DHL (Australia-Pacific). From 2013 to 2016, Doug was the Chairman of Australian Nuclear Science and Technology Organisation (ANSTO) and the General Manager of Business Development at ANSTO. Doug is a fellow of the Australian Society of CPAs and a Graduate of the Institute of Company Directors
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Dr. Jyoti Arora (Director of Operations)
Jyoti has extensive experience in project management, operations and GMP manufacturing. Prior to joining Telix, Jyoti was a Senior Project Manager at Cell Therapies Pty Ltd, with responsibility for overseeing product development of several advanced cell and gene therapy technologies. She holds a PhD in Medical Science and Radiopharmaceutical Chemistry from RMIT University
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Dr. Michael Wheatcroft (Director of R&D)
After completing a PhD in the Department of Biochemistry, Cambridge University, Mike worked at Cambridge Antibody Technology (now Medimmune). After moving to Melbourne in 2010, Mike oversaw the pre-clinical development of several engineered antibody drug conjugates at AviPep P/L. Mike has worked in senior development roles at Medicines Development Limited, Hatchtech Pty Ltd and Starpharma Limited
Dr. Marissa Lim (Director of Global Medical Affairs)
Marisa has held a number of senior and international medical director positions at Ipsen, Vifor and Hospira, BMS and Novartis, before joining Telix. She brings extensive experience in oncology trial design and management, particularly in disease focus areas relevant to Telix. Marissa obtained her medical degree from Monash University.
Ms. Alannah Evans (Director of Quality/Regulatory)
Alannah has 20 years of experience in quality-controlled manufacturing and biological material processing. Prior experience included technical and managerial roles at Nucleus Network, Cell Therapies P/L (Peter MacCallum Cancer Centre), Eastern Health and Gribbles Pathology. Alannah has a bachelor’s degree in biomedical sciences from Curtain University and master’s degree in biotechnology and business from RMIT.
Dr. Shintaro Nishimura (President, Telix Japan)
Shintaro is a highly-experienced drug development and commercialization professional, with particular emphasis on the use of molecular imaging in drug development. Prior to Telix, Shintaro held senior positions at Eli Lilly, ImaginAb and Astellas, as well as academic appointments at Kyoto Prefecture University of Medicine, the University of Tsukuba and Tokohu University. Dr. Nishimura received his doctorate in organic chemistry from Keio University and was a post-doctoral researcher at the University of Michigan Medical School.
Ms. Odile Jaume (President, Telix Europe)
Odile leads Telix’s European commercial activities, based in Brussels. Prior to joining Telix, Ms. Jaume held a variety of senior product management, marketing and commercial roles at Molecubes, Siemens, CTI Molecular Imaging and IBA. Ms. Jaume’s qualifications include an M.Sc in material science from the Université Catholique de Louvain (UCL) and an MBA from the University of Chicago, Booth School of Business.
Dr. Bernard Lambert (President, Telix USA)
Bernard was previously Vice President, CMC and Radiopharmaceutical Development at Zevacor Molecular and IBA Molecular, and led the manufacturing of 124I-girentuximab (the predecessor to Telix’s renal cancer imaging product) that was studied in the Phase III REDECT trial by Wilex AG. A radiochemist by training, Dr. Lambert was awarded a Ph.D in Chemistry from the University of Liège.
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Board of Directors
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Mr H. Kevin McCann AM (Chairman)
Kevin is currently Chairman of Citadel Group and Dixon Hospitality Limited. He is a former Chairman of Macquarie Bank Limited, Origin Energy, Healthscope Limited and ING Management Limited. Kevin practiced as a Commercial Lawyer as a Partner of Allens Arthur Robinson from 1970 to 2004 and was Chairman of Partners from 1995 to 2004. Kevin has a Bachelor of Arts and Law (Honours) from Sydney University and a Master of Law from Harvard University.
Dr. Mark Nelson (Non-Exec)
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Mark is the Chairman and Co-founder of The Caledonia Investments Group, a global investment management firm based in Sydney. He is Vice President of the Board of Trustees of the Art Gallery of NSW and serves on the Board of a number of other not for profit eneterprises including the Florey Neurosciences Institute. Mark holds a M.Phil in bioscience ]from the University of Cambridge and a Ph.D in molecular biology from the University of Melbourne.
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Dr. Christian Behrenbruch Dr. Andreas Kluge Executive Directors (see prev slide)
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Mr. Oliver Buck
Non-executive Director
Oliver is Founder of ITM Group, one of the largest isotope manufacturing and distribution companies in the world. He is an experienced executive and business developer in medical and defence industries. Oliver holds a masters degree in theoretical physics from the Technical University of Munich.
Ms. Melanie Farris
Company Secretary
Melanie is an experienced governance, communications and operations executive. Currently a non-executive director for Synapse Australia Limited, and in governance and operations roles with Factor Therapeutics Limited (ASX:FTT) and Invion Limited (ASX:IVX), previous roles include with HRH The Prince of Wales’s Office, Global Asset Management, Imperial Cancer Research Fund, and The Prince’s Foundation. Melanie holds a Bachelor of Communication (Public Relations), and a Graduate Diploma in Applied Corporate Governance. She is an Associate of the Governance Institute of Australia and an Associate of the Institute of Chartered Secretaries (UK).
Dr. Richard Zimmermann
Special Advisor
Dr Zimmermann spent 15 years at Beecham and Solvay before joining radiopharmaceutical industry as R&D Director with CISbio international in 1998. Richard was responsible for building the European PET/FDG manufacturing network for CIS/IBA and was VP Business Development for IBA Molecular. In 2012, Richard established Chrysalium Consulting, which provides specialized consulting expertise in radiopharmaceutical development and industrialization. Richard holds a Ph.D in chemistry from the University of Strasbourg.
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International scientific advisory board
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Dr. Rodney Hicks
Chief of Nuclear Medicine and Radiology, Peter MacCallum Cancer Centre (Melbourne, Australia). One of the world’s radio-pharmaceutical clinical thought leaders and strong advocate for the integration of PRRT/RIT into oncology standard care.
Dr. Jean-Francois Chatal
Professor, Univ. of Nantes (Nantes, France). Prof. Chatal pioneered the use of antibody-targeted therapies in nuclear medicine.
Dr. Jason Lewis
Chief of Radiochemistry, Vice-Chair of Radiology at MSKCC (NY, USA). Internationally recognised for innovation in the clinical production of radiopharmaceuticals.
Dr. Klaus Kopka
Head of the Division of Radiopharmaceutical Chemistry of the German Cancer Research Center (DKFZ) Heidelberg, Germany. His research interests focus on Radiopharmaceutical Sciences in combination with Labelling Chemistry and Medicinal Chemistry. A thought leader in PSMA targeting ligands.
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Dr. Neil Bander
Chair of Urology at Weill Cornell Medical Centre (NY, USA). First led the development of PSMA-targeting radiopharmaceuticals for prostate cancer.
Dr. Chaitan Divgi
Retired ex-Columbia / UPenn radiology and nuclear medicine. Experienced regulatory adviser and clinical translation consultant. Led the original clinical development of Girentuximab (TLX250).
Dr. Samuel Samnick
An accomplished radiopharmaceutical researcher stationed at the University of Wurzburg. He is a pioneer in the use of imaging and nuclide therapy targeting LAT1.
Dr. Richard Baum
Professor of Nuclear Medicine, Chairman & Clinical Director, Department of Molecular Radiotherapy at Zentralklinik Bad Berka, Germany. He is a thought-leader in the field of theranostic technology and has been one of the pioneers of peptide radiotherapy.
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Upcoming catalysts
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In progress : completion of the acquisition of Atlab SAS
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June/July : completion of FDA review of the manufacturing
package for prostate imaging program
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Commencement of commercial activity for prostate program –
Q3 first revenues
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June : formal launch of TLX101 glioblastoma study
(pending GMP manufacturing completion)
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End-June : major progress update on Phase III for TLX250 imaging
in Europe
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2-3 important commercial / partnering opportunities will be
concluded by Q3
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