CSL Ltd. — Regulatory Filings 2020

Jun 4, 2020

For immediate release

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5 June 2020

Partnership with the University of Queensland and CEPI to advance development and manufacture of COVID-19 vaccine candidate

(ASX:CSL; USOTC:CSLLY) Please find attached a media statement released today regarding a partnering agreement CSL has entered into with the University of Queensland and CEPI to accelerate the development, manufacture and distribution of a COVID-19 vaccine candidate

This media statement is provided to the ASX for the information of all CSL’s shareholders and contains no price sensitive information.

Authorised by Fiona Mead Company Secretary

For further information, please contact:

Media:

Jemimah Brennan Head of Asia Pacific Communications Telephone: +61 412 635 483 Email: Jemimah.Brennan@csl.com.au

Investors:

Mark Dehring Head of Investor Relations Telephone: +61 3 9389 3407 Email: mark.dehring@csl.com.au

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MEDIA RELEASE

The University of Queensland, CEPI and CSL partner to advance development and manufacture of COVID-19 vaccine candidate

• CSL appointed Trusted Manufacturer for University of Queensland’s “ molecular cla mp” enabled COVID- 19 vaccine candidate

• CEPI and CSL will share costs associated with the clinical development and manufacture of the vaccine candidate

• A vaccine is anticipated to be available in 2021 if clinical trials are successful

June 5, 2020, Oslo , Melbourne and Brisbane — CEPI, the Coalition for Epidemic Preparedness Innovations, CSL (ASX:CSL) and The University of Queensland (UQ) today announced that they have entered into a new , significant partnering agreement to accelerate the develop ment , manufacture and distribution of a COVID- 19 vaccine candidate which has been pioneered by researchers at UQ. The agreement formalises the support provided by CSL to UQ and CEPI from the outset of the pandemic earlier this year .

CEPI and CSL will fund the development and manufacture of UQ’s “molecular clamp” enabled vaccine for COVID- 19. Funding contributions will be used to provide support for the pending phase 1 safety study being led by UQ followed by subsequent late stage clinical trials, and industrial - scale manufacturing to allow the production of potentially millions of doses a year , should the product be approved .

Th e in itial ph ase of large- scale production of th e UQ COVID- 19 vaccin e is plan ned to take place at CSL’s biotech m an ufacturin g facilities in Melbourn e, Australia. Wh ile th ere are a num ber of critical m ileston es to be m et before th e vaccin e can be con sidered successful, CSL an ticipates th at th e production tech n ology can be scaled to produce up to on e h un dred m illion doses towards th e en d of 2021. CSL would also subcon tract oth er global m an ufacturers to in crease th e n um ber of doses th at can be produced an d broaden th e geograph ical distribution of vaccin e production .

Sh ould clin ical trials be successful, a vaccin e could be available for distribution in 2021.

The “ molecular clamp” vaccine platform

CEPI en tered in to a fram ework agreem en t with UQ in Jan uary 2019 to provide up to US$ 10.6 m illion to develop a rapid respon se “ m olecular clam p” vaccin e platform , a tran sform ative tech n ology paten ted by Un iQuest, UQ’s tech n ology tran sfer com pan y th at en ables rapid vaccin e design an d production again st outbreak viral pathogen s. In Jan uary 2020, CEPI expan ded its partn ersh ip with UQ to use th eir rapid respon se m olecular clam p vaccin e platform to produce a vaccin e can didate for COVID- 19 . UQ is n ow aim in g to take th e vaccin e can didate in to a ph ase 1 clin ical trial in July.

En veloped viruses h ave protein s on th eir surface th at drive fusion of th e virus an d h ost cell m em branes, a key process in in fection . These protein s are also th e m ajor target of a protective im m un e respon se. Alth ough they are able to in duce an im m un e respon se, th ey are in h eren tly un stable an d can ch an ge sh ape when expressed on th eir own . Th is m eans th at th e im m un e respon se in duced does n ot efficen tly recogn ise th e protein on th e virus surface and so does n ot provide protection from subsequen t in fection .

UQ h as overcom e th is problem by usin g th eir proprietary “ m olecular clam p” techn ology th at locks th e un stable, prefusion version of th e surface protein s in a form th at allows th e im m un e system to respon d m ore effectively. Th is is ach ieved usin g th eir proprietary “ m olecular clam p” tech n ology th at

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locks these proteins in their native virus surface form. This synthetic rapidly manufactured into a vaccine.

protein can then be purified and

Most recen tly, early preclinical results of th e UQ COVID- 19 vaccin e can didate sh owed th at it produced h igh levels of an tibodies th at can n eutralise th e virus.

Th e UQ COVID- 19 vaccin e will be com bin ed with Seqirus’ well- establish ed adjuvan t tech n ology – MF59[®] to im prove im m une respon se, reduce the am oun t of an tigen needed for each vaccin e, an d en able m ore doses to be m an ufactured m ore rapidly.

Allocation and distribution

Under the agreement, the allocation of doses between CEPI and CSL is linked to their relative contribu tion to overall project costs. Should the UQ COVID- 19 vaccine be successful, 100% of CEPI’s vaccine allocation will be distributed through the COVID - 19 Vaccine Global Access F acility, an instrument of the Vaccines pillar of the ACT Accelerator within w hich CEPI works in partnership Gavi - and the World Health Organisation CSL’s allocation will be used, at a minimum, to support its long standing biosecurity commitment to the Australian community as well as other key groups, such as its regional neighbours. CSL has granted CEPI a first right of refusal to any surplus doses, to be dis tributed through the COVID- 19 Vaccine Global Access Facility.

CEPI’s vaccine portfolio

To date, CEPI h as provided in itial support an d fun din g to Curevac, Inc ., Inovio Pharmaceuticals , In c., Moderna, Inc. , Novavax, Inc. , The University of Queensland , The University of Hong Kong , The University of Oxford , an d a con sortium led by Institut Pasteur, and Clover Biopharmaceuticals to develop COVID- 19 vaccin e can didates.

Rich ard Hatch ett, CEO of CEPI, said:

“ Th is sign ifican t partn ersh ip between CEPI, UQ an d CSL is an im portan t m ileston e in th e developm en t of UQ’s prom isin g COVID- 19 vaccin e can didate. Th e partn ersh ip will en able th e rapid developm en t of th e vaccin e can didate th rough clin ical trials, an d by in vestin g in large- scale m an ufacturin g capacity n ow, we can reduce th e tim e n eeded to deliver m illion s of doses of th e UQ vaccin e to th ose who n eed th em m ost if it proves to be safe an d effective.”

Jan e Halton , Ch air of CEPI, said:

“ Th is is an im portan t step forward in our battle again st th is virus. We kn ow th at the on ly way to beat th is pan dem ic is th rough collaboration , across coun tries an d also across sectors. We also kn ow th at we can n ot afford to wait un til we know wheth er a vaccin e works before en surin g we can produce it at scale. Th is partn ersh ip will ben efit enorm ously from CSL’s experien ce an d capabilities in vaccin e developm en t an d large- scale m an ufacturin g, wh ich is wh y th is is such an im portan t developm en t. If th is vaccin e is successful, th e partnersh ip m odel we h ave establish ed will en able CEPI to provide a sign ifican t n um ber of doses to th e COVID- 19 Vaccin e Global Access Facility for th ose wh o n eed th em m ost, wh ile allowin g CSL to fulfil its own lon g- stan din g biosecurity com m itm en ts.”

Professor An drew Cuth bertson , CSL’s Ch ief Scien tific Officer, said:

“ We are very pleased to be able to provide our scien tific expertise an d platform tech n ologies to m ake a stron g con tribution to th is critical join t effort with CEPI, th e Un iversity of Queen slan d an d oth ers. Th e devastatin g toll COVID- 19 has in flicted on th e world is bein g coun tered by an extraordin ary effort from scien tists wh o h ave crossed borders an d boun daries to collaborate, pool togeth er th eir resources an d m ake progress at a rate n ot seen before.

“ CSL will con tribute to UQ’s prom isin g vaccin e with our proprietary adjuvan t, MF59 , m ade by Seqirus, alon g with expertise in process scien ce an d scale- up from our Australian facilities, m an agin g advan ced clin ical trials an d th e large- scale m an ufacture of th e recom bin an t vaccin e. Should trials be successful, th is vaccin e h olds th e poten tial to provide protection again st th is urgen t public h ealth em ergen cy for Australian s an d th ose aroun d th e world vuln erable to th is devastatin g virus.”

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Professor Peter H ø j, Vice- Chancellor and President of the University of Q ueensland, said:

“We are absolutely delighted at the speed with which we have been able to reach this critical juncture, and off the back of positive results from our early preclin ical studies. This accelerated timeframe, hitting the key milestones in the development of the UQ vaccine, would not have been possible without CEPI, our partners and additional funding assistance from the Queensland State Government ($10m), the Federal Government ($ 5m) and philanthropic partners. Having CSL, an Australian - based global biotech leader , take our vaccine forward is a fantastic result for the dedicated research team who have worked tirelessly since January on this project, which will benefit Australians and the world.”

-ENDS-

About CEPI

CEPI is an innovative partnership between public, private, philanthropic, and civil organisations, launched at Davos in 2017, to develop vaccines to stop future epidemics. CEPI has moved with great urgency and in coordination with WHO in response to the emergence of COVID - 19. CEPI has initiated 9 partnerships to develop vaccines against the novel coronavirus. The programmes will leverage rapid response platforms already supported by CEPI as well as new partnerships. The aim is to advance COVID - 19 vaccine candidates into clinical testing as quickly as possible.

Before the emergence of COVID - 19 CEPI’s priority diseases included Ebola virus, Lassa virus, Middle East Respiratory Syndrome coronavirus, Nipah virus, Rift Valley Fever and Chikungunya virus. CEPI also invested in platfo rm technologies that can be used for rapid vaccine and immunoprophylactic development against unknown pathogens (Disease X).

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About the University of Queens land

UQ rates in the global top 50 as measured by the QS World University Rankings , US News Best Global Universities Rankings and CWTS Leiden Ranking s. The inventors of the patented molecular clamp technology Professor Paul Young, Associate Professor Keith Chappell, and Dr Dan Watterson have extensive expertise in molecular virology, viral pathogenesis and vaccine research.

About CSL

CSL (ASX:CSL) is a leading global biotechnology company with a portfolio of life - saving medicines, including those th at treat haemophilia and immune deficiencies, as well as vaccines to protect communities from seasonal influenza and global influenza pandemic threats. CSL — including our two businesses, CSL Behring and Seqirus - provides life - saving products to more than 60 countries and employs over 25,000 people. For more information about CSL Limited, visit www.csl.com

MEDIA CONTACTS

CEPI

Email: press@cepi.net Phone: +44 7387 055214

UQ

Email: communications@uq.edu.au Phone: +61 42 9056139

CSL Christina Hickie Email: Christina.hickie@csl.com.au Phone: +61 429 609 762

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