A N N U A L R E P O RT Answering the Call for a TB-Free World

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1 A N N U A L R E P O RT Aswerig the Call for a TB-Free World

A Global Respose Missio: Aeras is dedicated to the developmet of effective TB vaccie regimes that will prevet tuberculosis i all age groups ad will be affordable, available ad

2010 has bee a pivotal year for Aeras as the orgaizatio cotiues its mometum i developig ew tuberculosis vaccies ad layig the foudatio for a promisig ew decade, oe that offers

2 A Global Respose Missio: Aeras is dedicated to the developmet of effective TB vaccie regimes that will prevet tuberculosis i all age groups ad will be affordable, available ad adopted worldwide has bee a pivotal year for Aeras as the orgaizatio cotiues its mometum i developig ew tuberculosis vaccies ad layig the foudatio for a promisig ew decade, oe that offers the potetial of ew TB vaccies. With ew leadership guidig the orgaizatio through its ext phase, Aeras draws o a reserve of iteral ad exteral expertise ad experiece i collaboratio with the TB vaccie commuity i pursuit of its lifesavig missio. View the full multimedia versio of our 2010 Aual Report olie at

A Message from the CEO Dear Frieds, Doors ad Stakeholders, Tuberculosis is a devastatig disease that kills early 2 millio me, wome ad childre every year.

I am hoored to have joied the Aeras Global TB Vaccie Foudatio earlier this year, ad am deeply committed to developig ad deliverig iovative ew TB vaccies as part of the solutio.

Sice 2001, whe there were o ew vaccie cadidates i the cliic, the TB vaccie commuity has moved 12 ito cliical testig ad, today, ie TB vaccies are udergoig testig i trials worldwide.

3 A Message from the CEO Dear Frieds, Doors ad Stakeholders, Tuberculosis is a devastatig disease that kills early 2 millio me, wome ad childre every year. Freeig the world of tuberculosis is oe of the most pressig challeges i global health today. I am hoored to have joied the Aeras Global TB Vaccie Foudatio earlier this year, ad am deeply committed to developig ad deliverig iovative ew TB vaccies as part of the solutio. Tremedous strides have bee made. At the Secod Global Forum o TB Vaccies held i Talli, Estoia earlier this year, the TB vaccie commuity gathered to reflect o the advaces of the past decade. Sice 2001, whe there were o ew vaccie cadidates i the cliic, the TB vaccie commuity has moved 12 ito cliical testig ad, today, ie TB vaccies are udergoig testig i trials worldwide. This is a tremedous accomplishmet. Aeras ad its parters aloe have four cadidates i the cliic. Thaks to a exceptioal team effort, we are poised to have a fifth our recombiat BCG (AERAS-422) move ito the cliic i the Uited States later this year. Aother promisig cadidate developed i collaboratio with Crucell N.V., AERAS-402/Crucell Ad35, etered a Phase II trial i Keya. This is the secod Aeras-sposored proof-of-cocept trial to eroll ifats ad our first multi-ceter cliical trial to get uderway. Strog progress cotiues to be made o the other cadidates supported by Aeras i coordiatio with our parters at The Wellcome Trust, Oxford Uiversity ad Emerget BioSolutios o MVA85A/AERAS-485; GlaxoSmithKlie Biologicals o GSK M72; ad with States Serum Istitut, Saofi Pasteur, ad Itercell o SSI HyVac4/AERAS-404. Our 2010 Aual Report celebrates importat milestoes ad our collective progress made over the past year. While sigificat progress has bee made, importat scietific questios remai ad must be aswered. Additioally, as Aeras ad its parters advace umerous TB vaccie cadidates to later phases of cliical developmet ad associated costs rise, garerig the additioal support ad resources ecessary is of paramout importace. This is a particularly challegig task i today s ecoomic eviromet. We gratefully value our may parterships with loyal doors ad scietific collaborators. More tha ever, we eed to work together as a broad commuity to achieve the collaborative goal of deliverig TB vaccies that ca dramatically alter the deadly course of this devastatig disease. James E. Coolly Presidet ad CEO

2010 Milestoes ad Highlights Collaboratio alog the full value chai from basic sciece to delivery is essetial.

I 2008 early 9.5 millio people were diagosed with active TB disease ad almost two millio died.

Multidrug resistat (MDR) ad extesively drug resistat (XDR) strais of TB are o the rise ad are more difficult ad costly to treat.

4 2010 Milestoes ad Highlights Collaboratio alog the full value chai from basic sciece to delivery is essetial. Peter Small, MD, Seior Program Officer for TB, The Bill & Melida Gates Foudatio The global TB epidemic is becomig more threateig ad more deadly. Oe third of the world s populatio is ifected with TB. I 2008 early 9.5 millio people were diagosed with active TB disease ad almost two millio died. TB is a leadig killer of wome, hamperig a mother s ability to care for her family ad exposig her childre to the dager of becomig ifected. TB causes early 25 percet of HIV deaths globally. Multidrug resistat (MDR) ad extesively drug resistat (XDR) strais of TB are o the rise ad are more difficult ad costly to treat. The curret Bacille Calmette-Guéri (BCG) TB vaccie, itroduced ad give to ewbors early 90 years ago, is ureliable i prevetig adult pulmoary TB, the most commo form of the disease. I order to defeat TB, govermet, idustry, private fudig orgaizatios, academic istitutios ad the scietific commuity must work together to address the eed for a ew TB vaccie, oe that is safe for those livig with HIV ad effective agaist all forms of TB. Aeras is aswerig the call for a ew TB vaccie with a multi-level approach based o collaboratio with parters aroud the globe, i the lab ad i the field. From scietists explorig ew ideas ad immuologists workig to solve the mysteries of huma respose to cliical field researchers egagig with commuities ad local health authorities to eroll me, wome ad ifats i cliical trials, parterships with multiple players are critical i the fight to stop TB. Phase I Trial of Recombiat BCG Aouced Buildig o more tha a decade of global scietific research, Aeras scietists have egieered a ew ivestigatioal recombiat BCG (rbcg) vaccie that will udergo its first cliical trial i healthy adults to evaluate its immuogeicity ad safety. Thaks to a uiversal cross-aeras effort, AERAS-422 has progressed to a Phase I trial to be coducted i the Uited States startig i late Keya Phase II Ifat Trial Starts AERAS-402/Crucell Ad35, a ivestigatioal TB vaccie cadidate, etered a Phase II cliical trial i Kisumu, Keya. This is the secod Aeras-sposored proof-of-cocept trial to eroll ifats ad the first multi-ceter cliical trial to get uderway. Coducted i partership with the Keya Medical Research Istitute ad the US Ceters for Disease Cotrol ad Prevetio i Keya (KEMRI/CDC), stage oe of this two-stage trial is desiged to help researchers idetify the dose level of this viralvectored booster vaccie. I stage two, plaed for 2011, the trial will be expaded to locatios i Mozambique, South Africa ad Ugada. Data from cliical trials i the Uited States, South Africa ad Keya support the immuogeicity ad acceptable safety profile i adult, ifat ad HIV-positive adult populatios. Cambodia Epidemiological Study Begis The Cambodia Health Committee, with support from Aeras, iitiated a cross sectioal epidemiology study that will eroll up to 1,000 ifats ad childre youger tha five-years old i Svay Rieg Provice. This is the first study the two orgaizatios have coducted i partership ad the first Aeras-sposored study to be coducted i Cambodia, a coutry where TB ifects early oe millio people. The study will provide Aeras with iformatio ad data o the feasibility of coductig future cliical trials i Cambodia.

Phase II Ifat Trial Advaces i South Africa Whe the Phase II cliical trial of a TB vaccie cadidate called MVA85A/AERAS-485 got uderway last year, it was the start of the first proof of cocept trial of

Sice the, early 2,000 ifats have bee erolled i the trial led by the South Africa Tuberculosis Vaccie Iitiative (SATVI) i the Bolad regio of South Africa, a regio hit hard by tuberculosis.

Robi Dea-Fourie, the father of a trial participat o his motivatio to eroll his so.

the last decade ad to look forward to the challeges ad opportuities movig forward, icludig layig the groudwork for the itroductio of ew TB vaccies.

Slated for completio i 2011, the Blueprit for TB Vaccie Developmet will idetify trasformatioal ideas ad iovative mechaisms to achieve global targets ad provide guidace to the TB vaccie research

5 Phase II Ifat Trial Advaces i South Africa Whe the Phase II cliical trial of a TB vaccie cadidate called MVA85A/AERAS-485 got uderway last year, it was the start of the first proof of cocept trial of a ew TB vaccie i 80 years. Sice the, early 2,000 ifats have bee erolled i the trial led by the South Africa Tuberculosis Vaccie Iitiative (SATVI) i the Bolad regio of South Africa, a regio hit hard by tuberculosis. A total of 2,784 ifats will be erolled. If people do t uderstad TB they must uderstad oe thig: that life is sacred ad we must protect what is closest to us with everythig. Robi Dea-Fourie, the father of a trial participat o his motivatio to eroll his so. TB Vaccie Leaders Frame the Future The Secod Global Forum o TB Vaccies coveed 200 scietists ad researchers from 31 coutries i Talli, Estoia i September to review progress i the TB vaccie field over the last decade ad to look forward to the challeges ad opportuities movig forward, icludig layig the groudwork for the itroductio of ew TB vaccies. Through a collaborative process ad based o shared lessos leared, members of the TB vaccie field, icludig Aeras, coveed workshop discussios o a ew pla for TB vaccie developmet. Slated for completio i 2011, the Blueprit for TB Vaccie Developmet will idetify trasformatioal ideas ad iovative mechaisms to achieve global targets ad provide guidace to the TB vaccie research commuity. NIH ad FDA Provide Support The US Natioal Istitutes of Health s Natioal Istitute of Allergy ad Ifectious Diseases ad the US Food ad Drug Admiistratio awarded first-ever grats to Aeras ad its research parters i two importat areas of TB vaccie research: the developmet ad evaluatio of a ew geeratio of viral vectored ad recombiat BCG vaccies ad the discovery of biological ad immuoological biomarkers for TB vaccies. Both areas of research are critical to maitaiig mometum i TB vaccie developmet ad uderstadig how TB vaccies work i the huma body. The NIH grat, focused o the developmet ad evaluatio of a ext geeratio of vaccie cadidates, awards support for a project with a total budget of $865,500 over three years. The FDA grat, which supports work doe i collaboratio with Oxford Uiversity, Sait Louis Uiversity, Albert Eistei College of Medicie ad the Uiversity of Cape Tow, supports a project aticipated to cost $785,940 over three years. UK Govermet Ivests Geerously Aeras reached a ew milestoe this year whe it received a geerous first-time grat of 8 millio from the govermet of the Uited Kigdom (UK). The ivestmet from the UK Departmet for Iteratioal Developmet (DFID) is particularly sigificat durig the curret ecoomic climate. The grat is a iteratioal sig of support for the developmet of ew TB vaccies that are desiged to provide icreased protectio from TB. The fudig is beig applied to efforts to develop ad licese improved TB vaccies for use i high-burde coutries. We were really pleased last year they made this aoucemet to fud Aeras... we thik it s a very positive sig that the govermet is recogizig the eed for log term ivestmet i ew tools. Louise Holly, Deputy Director, RESULTS UK

6 2009 Fiacials This report icludes a fiacial sapshot from This period coicided with the recet global ecoomic crisis. May o-profit orgaizatios aroud the world were egatively impacted by the ecoomic crisis, ad the Aeras Global TB Vaccie Foudatio was o exceptio. May doors saw their ow reveues declie. I the face of this ew fiacial reality, Aeras s leadership had to make some difficult choices i order to uphold our fiscal resposibilities ad maitai progress toward our missio. That we have maaged to achieve the remarkable progress i our research ad developmet described i this report is a testamet to the dedicatio of our staff ad our parters. We are curretly ivestig i ew ad prove fudraisig strategies to positio Aeras to its best advatage as the ecoomy recovers. We would like to express our deepest gratitude to our supporters, both vetera ad ew, for helpig Aeras weather the storm ad cotiue its lifesavig work Research & Developmet Expeditures Cliical & Field Sites $22M Vaccie Assessmet $7.9M Vaccie Discovery $6.4M Techical Operatios $14.5M 2009 Total Program & Support Services Maagemet & Admiistratio $4.9M Advocacy, Fudraisig & Commuicatio $1.6M To support TB vaccie developmet efforts, visit US federal employees ca support Aeras through the Combied Federal Campaig usig # Research & Developmet $50.8M Amouts are i millios of US dollars. Visit fiacials.html to view the 2009 Statemet of Activities. Audited aual fiacial statemets are available upo request. Doors The Aeras Global TB Vaccie Foudatio ca oly be successful with the cotiued support of our doors. Aeras gratefully ackowledges the followig doors whose geerosity i support of our work is deeply appreciated. View the full multimedia versio of our 2010 Aual Report olie at Aeras Global TB Vaccie Foudatio 1405 Research Blvd. Rockville, MD USA phoe: fax: Aeras Africa Office - South Africa First floor, Belmot Square Belmot Road Rodebosch Cape Tow 7700 SOUTH AFRICA phoe: +27 (0) fax: +27 (0) Photo Credits: Richard Lord, Joh-Michael Maas, Elizabeth Roll

Pilot and Exploratory Project Support Grant

Pilot and Exploratory Project Support Grant KEY DATES LETTERS OF INTENT DUE November 3, 2014 5:00 pm est FULL PROPOSAL INVITATIONS November 17, 2014 FULL PROPOSAL DEADLINE Jauary 15, 2015 5:00 pm est NOTIFICATION OF AWARDS April, 2015 Pilot ad Exploratory