Bioshares 2017bioshares.com.au/presenations2017/s107behrenbruch.pdf · Investor Introduction Telix...

1Investor Introduction Telix Pharmaceuticals Limited

Bioshares2017

Queenstown, 22 July 2017

2Company Introduction Telix Pharmaceuticals Limited

This disclaimer applies to this presentation and the informationcontained in it (the “Presentation”). By reading this disclaimer youagree to be bound by it. The Presentation has been prepared byTelix Pharmaceuticals Limited and relates to its subsidiaries,related parties and any new entity subsequently incorporatedfollowing the date on which the Presentation was prepared(collectively “Company”). The Presentation was prepared on the4th of July 2017 and the information in it is subject to changewithout notice.

Confidential informationThe Presentation is confidential and is intended only for the personto whom it was first given. By receiving the Presentation, you agreeto keep it confidential, not to disclose it to any other person andnot to copy, use, publish, record or reproduce it, in whole or inpart, without the prior written consent of the Company, which maybe withheld in its absolute discretion.

Not an offer or financial product adviceThe Presentation does not constitute an offer, invitation,solicitation or recommendation with respect to the purchase orsale of any security in the Company nor does it constitute financialproduct advice. The Presentation is not a prospectus, productdisclosure statement or other offer document under Australian lawor under any other law. The Presentation has not been filed,registered or approved by regulatory authorities in any jurisdiction.The Presentation is not intended to be relied upon as advice or arecommendation to investors and does not take into account theinvestment objectives, financial situation, taxation situation orneeds of any particular investor. An investor must not act on thebasis of any matter contained in the Presentation but must makeits own assessment of the Company and conduct its owninvestigations and analysis. Investors should assess their ownindividual financial circumstances and consider talking to afinancial adviser, professional adviser or consultant before makingany investment decision.

PurposeThe Presentation is for information purposes only and is anoverview and does not contain all information necessary to makean investment decision or that would be required in a prospectusor product disclosure statement prepared in accordance with therequirements of the Corporations Act 2001 (Cth) (“CorporationsAct”). The Presentation is of a general nature and does not purportto be complete or verified by the Company, Taylor Collison Limited(“Lead Manager”) or any other person. None of the Company orthe Lead Manager have any responsibility or obligation to informyou of any matter arising or coming to their notice, after the dateof the Presentation, which may affect any matter referred to in thePresentation.

No guarantee, representation or warrantyWhile reasonable care has been taken in relation to thepreparation of the Presentation, none of the Company or the LeadManager or their respective directors, officers, employees,contractors, agents, or advisers nor any other person (“LimitedParty”) guarantees or makes any representations or warranties,express or implied, as to or takes responsibility for, the accuracy,reliability, completeness or fairness of the information, opinions,forecasts, reports, estimates and conclusions contained in thePresentation. No Limited Party represents or warrants that thePresentation is complete or that it contains all information aboutthe Company that a prospective investor or purchaser may requirein evaluating a possible investment in the Company or acquisitionof shares in the Company. To the maximum extent permitted bylaw, each Limited Party expressly disclaims any and all liability,including, without limitation, any liability arising out of fault ornegligence, for any loss arising from the use of or reliance oninformation contained in the Presentation includingrepresentations or warranties or in relation to the accuracy orcompleteness of the information, statements, opinions, forecasts,reports or other matters, express or implied, contained in, arisingout or derived from, or for omissions from the Presentation

including, without limitation, any financial information, anyestimates or projections and any other financial informationderived therefrom.

Forward-looking statementsThe Presentation includes forward-looking statements andcomments about future events, including the Company’sexpectations about the performance of its businesses. Forward-looking words such as “expect”, “should”, “could”, “may”,“predict”, “plan”, “will”, “believe”, “forecast”, “estimate”, “target”or other similar expressions are intended to identify forward-looking statements. Such statements involve known and unknownrisks, uncertainties, assumptions and other important factors,many of which are beyond the control of the Company and whichmay cause actual results, performance or achievements to differmaterially from those expressed or implied by such statements.Forward-looking statements are provided as a general guide only,and should not be relied on as an indication or guarantee of futureperformance. Given these uncertainties, recipients are cautionedto not place undue reliance on any forward-looking statement.Subject to any continuing obligations under applicable law, theCompany disclaims any obligation or undertaking to disseminateany updates or revisions to any forward-looking statements in thePresentation to reflect any change in expectations in relation toany forward-looking statements or any change in events,conditions or circumstances on which any such statement is based.Past performance is not indicative of future performance and noguarantee of future returns is implied or given. Nothing containedin the Presentation nor any information made available to you is,or shall be relied upon as, a promise, representation, warranty orguarantee as to the past, present or the future performance of theCompany. No Limited Party or any other person makes anyrepresentation, or gives any assurance or guarantee that theoccurrence of the events expressed or implied in any forward-looking statements in the Presentation will occur.

Notice


We are pleased to sponsor this session…

4Company Introduction Telix Pharmaceuticals Limited 4Company Introduction Telix Pharmaceuticals Limited

Company Overview

Australian unlisted public company

• Seed financing completed January 2017

• Melbourne HQ

• ~20 people across Australia, France, Germany, US

Purpose

• Develop a portfolio of late-stage oncology assets

• Personalised medicine strategy: imaging + therapy

5Company Introduction Telix Pharmaceuticals Limited 5

The Co-Founders

Dr. Christian Behrenbruch (Director and CEO)Serial entrepreneur, six companies launched in imaging/nuclear medicine. Former Sr. VP Siemens Health. Co-Founder and CEO, ImaginAb Inc. Executive Director, Factor Therapeutics (ASX: FTT).

Dr. Andreas Kluge (Director and CMO)Runs the most successful nuclear-medicine dedicated CRO (ABX-CRO). Has taken products from early translation through Phase III (>30 programs) in the US and EU. ABX CRO a strategic partner to Telix.

Mr. Oliver Buck (Director)Founder/Owner of ITM Group, one of the largest isotope manufacturing and distribution companies in the world. Experienced exec and business developer in medical and defence industries.

Dr. Richard Zimmermann (Director)Former VP R&D for IBA Molecular Imaging. Runs a business intelligence company focused on the radiopharmaceutical industry with a substantial “big pharma” client base looking aggressively at this space.

Company Introduction Telix Pharmaceuticals Limited


Our Scientific Advisory BoardDr. Rodney HicksChief 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 ChatalProfessor, Univ. of Nantes (Nantes, France). Prof. Chatal pioneered the use of antibody-targeted therapies in nuclear medicine.

Dr. Jason LewisChief of Radiochemistry, Vice-Chair of Radiology at MSKCC (NY, USA). Internationally recognised for innovation in the clinical production of radiopharmaceuticals.

Dr. Klaus KopkaHead 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.

Dr. Neil BanderChair of Urology at Weill Cornell Medical Centre (NY, USA). First led the development of PSMA-targeting radiopharmaceuticals for prostate cancer.

Dr. Chaitan DivgiRetired ex-Columbia / UPenn radiology and nuclear medicine. Experienced regulatory adviser and clinical translation consultant. Led the original clinical development of Girentuximab (TX250).

Dr. Samuel SamnickAn 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 BaumProfessor 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.


7Company Introduction Telix Pharmaceuticals Limited 7Investor Introduction Telix Pharmaceuticals Limited

Molecularly Targeted Radiation…

A LinkerChemistry to attach the

“payload” to the

targeting agent

Targeting AgentCan be a small molecule or a

biologic (antibody)

The “Payload”A radioactive isotope. Can be a diagnostic isotope for imaging,

or a therapeutic isotope for treatment

Cancer Target


Cancer Cell

8Company Introduction Telix Pharmaceuticals Limited 8Company Introduction Telix Pharmaceuticals Limited

…Will Replace External Beam Therapy (EBT)

External beam therapy (EBT)• A core part of cancer treatment

• “Externally Targeted” from a machine (a linear accelerator)

• ~Mulit-$Bn global market, growing fast because it is reasonably cheap/effective

Targeted Radiopharmaceuticals• Deliver radiation only to areas where required

• Injected, “Molecularly Targeted”

• Able to target very small tumours not able to be seen with standard imaging and therapy systems

• Far less “collateral” damage to healthy tissue

Exte

rnal

Inte

rnal


Diagnostic imaging drives a precision therapy approach…

Imaging for staging and therapy planning

Theranostic

Tumour Cell

Personalised therapy to maximise treatment efficacy,

minimise side-effects



Radiopharmaceuticals : Unloved … Until Now


Similarly – Telix’s Prostate Program…

• Several PhII trials have been executed in the US under academic INDs

• ~165 patients (total) have been treated to date at different doses

• Pooled analysis indicates TX591 confers as high as a 30+ month survival benefit compared to with ~3 months benefit to Xofigo® care in a comparable patient population

• In this application, diagnostic imaging is used for dose planning only (i.e. patients are already diagnosed as metastatic from other imaging procedures). However PSMA expression levels matter - patients that have high expression of the target do better (see diagram on the following page)


Cost-BenefitClinical utility must

demonstrate a defensible

cost-benefit, whether

diagnostic or therapeutic use.

CareMust integrate – or have the

potential to integrate with

existing best practice of

medicine.

Clinical DataAll programs must have

demonstrated clinical efficacy

and utility.

ViableMust be manufacturable,

with a supply chain and

scale-up strategy for global

distribution.

Our Product Selection Criteria

Company Introduction Telix Pharmaceuticals Limited 12


Our Pipeline

First Ph III trial, second confirmatory trial to be

completed

• Our advanced-stage pipeline means we are <3 years to first revenue and partnerships

(+anti-androgens)

(+EBT)

(+PD-L1)


An Evolving, Compact Market

Three major developments have transformed the industry:

✓ Demonstration of impressive efficacy

✓ “Next generation” isotopes that are easy on patients and physicians

✓ Established supply chain

TargetedPoorly marketed to oncologists, weak supply chain and clinically unwieldy131I, 90YBexxar, Zevalin

PhysiologicalNo targeting agent, but commercially successful131I-thyroid, 153Sm, 223Ra, 90YXofigo, SIR-Spheres

True “Theranostics”New isotopes, easy to use, established supply chains – “big pharma” is finally interested177Lu and in the future, 225Ac, 211At


Our Gameplan

• Manufacturable programs : production, conjugation, isotopes

• Invest properly in clinical trials, that integrate with standard care

• TK/checkpoints for kidney

• Androgens for prostate

• EBT for glioblastoma

• Build a pipeline of validated assets

• That would be worthy of “cornerstoning” a new radiobiology division of a major pharmaceutical company


Regulatory Strategy

Our approach has advantages:

•Imaging use has a faster approval pathway, de-risking therapeutic program that follows. Validates the manufacturing package in advance

•Imaging serves as a patient selection tool to maximise

efficacy and cost of therapeutic trials

•Imaging de-risks toxicity/off-target effects early

Telix’s pipeline has expedited status

•US/EU orphan designation (TX101) for therapy

•FDA Special Protocol Assessment (TX250) for the imaging application

•Australian-US footprint is strategic as TGA allows rapid

clinical translation, well-regarded by the FDA



Intellectual Property

Extensive Protection• Commercially validated

Patents• 11 patent families

• Coverage in all major jurisdictions

• Provide product protection beyond 2030

• Considerable utility/application IP as well

Biological Resources• TX250/591 are biologics : Cell lines, manufacturing processes are

proprietary and difficult to replicate

• Data and market exclusivities (US/EU)



A Big Task Ahead…


Summary

• Important Tx segment undergoing transformation

• Oncology applications with major clinical unmet need

• Mostly mid-late stage assets – de-risked, strong clinical evidence

• Clear path to revenues and partnerships in < 3 years

• Strong news flow and collaborative opportunities

• SPA and orphan designations for several programs to support

expedited approvals

• Major value program value inflections will be achieved

in the next 12-18 months



Contacts

Dr. Christian Behrenbruch (CEO)@: [email protected]

USA: +1 310 904 3384

AUS: +61 40606 3247

www.telixpharma.com

Corporate Counsel: Clarendon Lawyers

IP Counsel: Freehills Patent Attorneys (FPA)

Corporate Advisor: Taylor Collison Limited

Auditor: PwC


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