Aveo Pharmaceuticals (AVEO) 8-K This presentation contains forward-looking statements within the meaning of the Private Securities

CORP OVERVIEW

1

April 2015

Exhibit 99.1

Forward-Looking Statements

2

This presentation contains forward-looking statements within the meaning of the Private Securities

Litigation Reform Act of 1995. All statements, other than statements of historical facts, contained in this

presentation are forward-looking statements. The words “anticipate,” “believe,” “estimate,” “expect,”

“intend,” “may,” “plan,” “predict,” “project,” “target,” “potential,” “will,” “would,” “could,” “should,” “continue,”

“contemplate,” or the negative of these terms or other similar expressions are intended to identify

forward-looking statements, although not all forward-looking statements contain these identifying words.

These forward-looking statements include, among others, statements about: AVEO’s plans to leverage

biomarkers and pursue strategic partnerships for certain of its assets, including AVEO’s plans to

develop a commercial scale biomarker for tivozanib; AVEO’s goals and business strategy and its ability

to optimize its resources; the timing and results of preclinical and clinical trials; the timing and response

of meetings with regulatory authorities; AVEO’s approach to treat cachexia and AVEO’s estimates for its

cash runway. 

Actual results or events could differ materially from the plans, intentions and expectations disclosed in

the forward-looking statements AVEO makes due to a number of important factors, including substantial

risks and uncertainties relating to: AVEO’s ability to successfully implement its restructuring and

strategic plans; AVEO’s ability to successfully develop, test and gain regulatory approval of its product

candidates, including its companion diagnostics; AVEO’s ability to obtain necessary financing; AVEO’s

ability to establish and maintain new strategic partnerships; AVEO’s ability to obtain, maintain and

enforce intellectual property rights; competition; AVEO’s dependence on its strategic partners and other

third parties; adverse economic conditions; and those risk factors discussed in the “Risk Factors” and

elsewhere in AVEO’s Annual Report on Form 10-K for the year ended December 31, 2014, and other

periodic filings AVEO makes with the SEC.  All forward-looking statements contained in this

presentation speak only as of the date of this presentation, and AVEO undertakes no obligation to

update any of these statements, except as required by law.

AVEO is Leveraging Biomarkers and Partnerships in

Seeking to Advance its Robust Pipeline of Assets

3

Substantial Ownership of all Programs

Most advanced stage of development

GDF-15 Biomarker Cachexia

NRG-1 Biomarker Solid Tumors

Serum Proteomic Biomarker NSCLC

Angiogenesis Biomarkers CRC

Ocular Diseases

Potential EU File 1st line RCC

TIVO-1 Crossover  Refractory RCC

Program

Pathway

Development

Candidate

Preclinical

Phase 1

Phase 2

Phase 3

Rights

Own ex-Asian

rights

Wholly Owned

Wholly Owned

Ficlatuzumab

HGF MAb

AV-203

ERBB3 MAb

AV-380

GDF15 MAb

Tivozanib

VEGFR 123 TKI

Tivozanib

4

Tivozanib –

VEGFR 1, 2 & 3 Tyrosine Kinase Inhibitor

•

Potent, selective inhibitor of VEGFRs 1, 2, and 3

with a long half-life that is designed to optimize

blockade while minimizing off-target toxicities

1,2

•

Patent term: 2022 (composition of matter) with

potential extension to 2027

•

Orphan drug designation in Europe for RCC

1. Nakamura K et al. Cancer Res 2006;66:9134–9142.

2. Eskens FA et al. Clin Cancer Res 2011;17:7156–7163.

5

1.

Reacquired worldwide rights (Aug 2014)

2.

Ophthotech option agreement to evaluate in ocular indications (Nov 2014)

3.

Received confirmation of eligibility for MAA from the EMA for RCC (Jan 2015)

4.

Presented BATON CRC NRP-1 serum biomarker results at AACR

Angiogenesis Meeting

5.

Ongoing evaluation of strategies to advance tivozanib

Tivozanib Preclinical Activity in Ocular Models

April 8, 2015

6

6

Compared to the vehicle-treatment, tivozanib

suppressed

the

development

of

CNV

lesions

and

led

to

a

significant

regression

of

established

CNV,

reducing the affected areas by 80.7% and 67.7% respectively

Ophthotech Research and Option Agreement: Nov. 2014

April 8, 2015

7

7

Agreement

Research and Exclusive Option Agreement for

Non-Oncology Disease of the Eye

Territory

Worldwide ex-Asia

Upfront

$500,000

Option Term Milestones

$2M at IND filing and $6M based upon the

achievement of specified R&D, business goals

Option Payment*

$2M

Clinical and Regulatory Milestones*

$50M

Sales-based Milestones*

$45M

Royalties

Tiered, double digit royalties, up to the mid-

teens, on net sales

Agreement monetizes tivozanib while retaining oncology indications and

providing significant potential downstream value for AVEO

All payments received by AVEO subject to sublicense revenue obligation to Kyowa Hakko Kirin

* Assumes execution of option by Ophthotech

8

Evaluating Potential for MAA Filing for RCC

TIVO-1 Randomized Phase 3

April 8, 2015

•

Met primary PFS endpoint

of superiority vs sorafenib

•

First H2H RCC pivotal trial

to show superiority over

another VEGF TKI

•

Demonstrated

differentiated safety profile

•

OS confounded by

crossover

•

Median OS similar to

historical TKI agents, 

despite lack of subsequent

therapy

9

Overall Survival TIVO-1

NA/EU

(N=186)

Unstratified Analysis

HR=0.89

p=0.58

Primary Stratified Analysis

HR=0.87

p=0.49

Includes: US,

Canada,

EU Member States

(Bulgaria,

Czech

Republic,

France,

UK,

Hungary,

Italy,

Poland,

Romania)

Favorable OS Trend when Including All US and EU Patients

Enrolled in TIVO-1 (186 patients)

10

Efficacy Data for All US and EU Patients Enrolled in TIVO-1

(186 patients)

Tivozanib

N = 98

Sorafenib

N = 88

Median PFS

14.7

(9.2, 18.0)

8.5

(5.7, 10.9)

PFS

HR

Unstratified

0.57 (0.41, 0.78),

p < 0.001

Stratified

0.53 (0.38, 0.74), p < 0.001

Progression Free Survival (PFS)

Overall Survival (OS)

Tivozanib

N = 98

Sorafenib

N = 88

Median OS

35.9

(21.9, NA)

31.0

(24.1, 42.1)

OS

HR

Unstratified

0.89 (0.60, 1.33),

p=0.58

Stratified

0.87 (0.58, 1.30), p=0.49

Includes: US,

Canada,

EU Member States

(Bulgaria,

Czech

Republic,

France,

UK,

Hungary,

Italy,

Poland,

Romania)

11

Data from the TIVO-1 Study for Treatment Post-VEGF TKI

Progression Compare Favorably to Competing Agents

April 8, 2015

12

Study

AXIS: 

Phase

3,

2

line

RCC

axitinib vs sorafenib

(1:1)

Dovitinib study: 

Phase

3,

3

rd

line

RCC

dovitinib vs sorafenib

(1:1)

TIVO-1: 

Phase

3,

2

nd

line

RCC

subset crossing over to

tivozanib following

sorafenib progression

Study Size

n=361 (axitinib arm)

n=362 (sorafenib arm)

n=280 (dovitinib)

n=284 in sorafenib arm

n=163 (tivozanib)

PFS

sunitinib refractory pts

6.5 mo (axitinib) vs.

4.5 mo (sorafenib)*

3.7 mo (dovitinib) vs.

3.6 mo (sorafenib)

sorafenib refractory pts

8.4 mo^ (tivozanib)

PFS HR

HR = 0.636, p<0.0002*

HR 0.86, p=0.063

OS

20.1 mo (axitinib) vs.

19.2 mo (sorafenib)

11.1 mo (dovitinib) vs

11.0 mo (sorafenib)

19.6 mo^ (tivozanib)

OS HR

HR = 0.969, p =0.374

HR 0.96, p =0.357

* n= 389; investigator assessed PFS;                           

independent PFS = 4,8 mo vs. 3.4 mo, HR = 0.741 (p=0.011)

^Motzer et al ASCO GU 2013 (Data to be updated at ASCO 2015)

nd

Potential Phase 3 Confirmatory Study Design in

Recurrent/Metastatic RCC

“We recommend that you perform an adequate and well-controlled randomized trial(s) of tivozanib using

PFS as the primary endpoint and OS as a secondary endpoint. You should ensure the applicability of

the results from this trial to the US population. The trial should be powered to detect a difference in PFS

and adequately sized to reassure us that there is no adverse effect on OS. The design, conduct, and

results of this trial will determine whether one additional trial will be sufficient for approval purposes.”

-

FDA COMPLETE RESPONSE Letter 6/6/13

April 7, 2015

13

N = 300 -

400

tivozanib

sorafenib

•

1

O

: PFS

•

2

O

: OS, ORR, DoR,

Safety and

tolerability for ITT &

Pre-Specified

Biomarkers

Phase 3, Randomized, Controlled, Multi-Center, Open-Label Study to Compare

Tivozanib to Sorafenib in Subjects With Refractory Advanced Renal Cell Carcinoma

•

Recurrent/metastatic RCC

•

Failed at least two prior

regimens including VEGFR-

TKI (not sorafenib)

•

ECOG PS 0 or 1

April 8, 2015

•

Final results (AACR Angiogenesis 2015) suggest that tivozanib+mFOLFOX6 is comparable

to bevacizumab+mFOLFOX6 in the ITT population, with an acceptable safety profile.

•

PFS:  9.8 (Tivo) vs 9.5 (Bev) months; HR=0.908, p=0.598

•

ORR:  46.9% (Tivo) vs. 43.2% (Bev)

•

Final pre-specified biomarker analysis (AACR Angiogenesis 2015) suggest NRP-1 is

prognostic for outcome regardless of choice of anti-VEGF therapy and predictive for

improved PFS for Tivo over Bev

•

Biomarker IP filed in January 2015, commercial CDx antibody identification and assay

development efforts initiated

N = 265

tivozanib

+

mFOLFOX6

bevacizumab

+

mFOLFOX6

•

1

O

: PFS*

•

2

O

: OS, ORR, DoR,

TTF, HRQol, Safety

and tolerability for

ITT & Pre-Specified

Biomarkers

* Interim ITT PFS analysis (after full enrollment)

indicated futility for superiority of  Tivo vs. Bev

Colorectal Cancer (CRC)

14

•

1

line Stage IV mCRC

•

No fluorouracil adj tx

<6 months

•

ECOG PS 0 or 1

st

Tivozanib Treatment Resulted in Comparable PFS Outcomes

as Avastin in ITT Population; Investigator Assessment

April 7, 2015

CI, confidence interval; HR, hazard ratio

15

NRP-1 Levels Were Prognostic for PFS for both Tivozanib (A)

and Bevacizumab (B) Treated Patients*

April 8, 2015

a

Unstratified PFS analysis: (n=108; events=56); log rank test

P

value=2.88e-7; HR (95% CI): 0.21 (0.11, 0.41).

(A) PFS for tivozanib arm

a

Time to event (PFS) in months

NRP-1 low (n=52)

Median PFS=17.9 months

NRP-1 high (n=56)

Median PFS=7.3 months

b

Unstratified PFS analysis: (n=54; events=34); log rank test

P

value=0.059; HR (95% CI): 0.506 (0.246, 1.04).

Time to event (PFS) in months

NRP-1 low (n=28)

Median PFS=11.2 months

NRP-1 high (n=26)

Median PFS=7.5months

(B) PFS for bevacizumab arm

b

*Utilizing predefined median NRP-1 cutoff

NRP-1 Low (A) Was Predictive for Tivozanib Benefit over

Bevacizumab while High (B) Levels Were Not*

Time to event (PFS) in months

Tivozanib (n=52)

Median PFS=17.9 months

Bevacizumab (n=28)

Median PFS=11.2 months

a

Unstratified analysis: (n=80; events=31); log rank test

P

value=0.0075; HR (95% CI): 0.38 (0.183, 0.794).

b

Multivariate

analysis

(cancer

origin,

met

sites,

LDH);

Wald

test

P

value=0.0034; HR (95% CI): 0.30 (0.133, 0.671).

(A) NRP-1 low

a,b

Tivozanib (n=56)

Median PFS=7.33 months

Bevacizumab (n=26)

Median PFS=7.46 months

Time to event (PFS) in months

(B) NRP-1 high

c,d

c

Unstratified analysis: (n=82; events=59); log rank test

P

value=0.99; HR (95% CI): 1.00 (0.997, 0.575).

d

Multivariate analysis (cancer origin, met sites, LDH);

Wald

test

P

p

value=0.68;

HR(95%

CI):

1.12

(0.639,

1.980).

17

*Utilizing predefined median NRP-1 cutoff

Similar Prognostic Value of NRP-1 Observed in Renal

and Other Cancers for VEGF inhibitors

April 8, 2015

18

TIVO-1:

Tivozanib-Treated

Patients

With

High

vs

Low

NRP-1

Levels

Based

on

a

Median

Cutoff

•

Similar observations across several tumor types, including breast, gastric and colorectal

cancers, with anti-VEGF therapies such as Avastin and Zaltrap

Where Are We Now with Tivozanib?

•

RCC EU

–

Rapporteur

meetings

scheduled

to

discuss

opportunity

for

EU

file

with

TIVO-1

data

for

1

st

line

RCC

(2Q15)

•

RCC Global

–

Planned ASCO 2015 presentation of updated VEGF TKI refractory PFS

data from TIVO-1 crossover

–

FDA meeting scheduled to discuss potential for phase 3 refractory RCC

study vs sorafenib to serve as confirmatory study for TIVO-1 (2Q15)

•

CRC Global

–

Engaged Myriad to identify NRP-1 antibody which could be suitable for

use in a commercial CDx assay for tivozanib in colorectal cancer

–

FDA meeting scheduled to discuss potential development and

registration paths forward for tivozanib in CRC (2Q15)

April 8, 2015

19

Ficlatuzumab

20

•

A Favorable Profile to In-Class Antibodies

–

High affinity (pM) and slow off-rate for HGF

–

High potency (nM) inhibiting all biological activities of

HGF,

including

autocrine/paracrine

activation

loops

–

In vivo preclinical efficacy superior to in-class

antibodies

Ficlatuzumab –

Humanized IgG1k MAb Inhibitor of HGF

21

Data on file

*  January 2028 expiry in US and June 2027 expiry in Europe and Japan

1.

Identified potential serum proteomic biomarker: Biodesix VeriStrat

®

2.

Finalized Biodesix partnership to fund confirmatory phase 2 study (April 2014)

3.

Presented Phase 2 Biodesix VeriStrat

®

analysis (ESMO 2014)

4.

Confirmatory phase 2 NSCLC study open

•

Patent Term: 2027-28 (composition of matter)

with potential extension to 2032-2033*

Ficlatuzumab Randomized Phase 2 Study (P06162):

Exploratory Analysis Results*

VeriStrat

®

may be a predictive biomarker for the combination of

ficlatuzumab + EGFR TKI over EGFR TKI alone

Observation to be confirmed in the Phase 2 FOCAL study, initiated in 2014

22

* Mok et al ESMO 2014

VeriStrat

Poor

(VSP)

ficlatuzumab + gefitinib

n=18

gefitinib alone

n=17

OS

Median

23.9 months

5.8 months

Hazard

Ratio

0.41

p-value

0.032

PFS

Median

7.4 months

2.3 months

Hazard

Ratio

0.41

p-value

0.014

VSP

&

EGFRm

ficlatuzumab + gefitinib

n=5

gefitinib alone

n=6

OS

Median

17.8 months

10.4 months

Hazard

Ratio

0.3

p-value

0.09

PFS

Median

11.1 months

2.3 months

Hazard

Ratio

<0.01

p-value

<0.01

Biodesix Partnership: April 2014

AVEO and Biodesix Partner to Co-Develop and Commercialize

Ficlatuzumab with a Companion Diagnostic

–

Unique collaboration where the diagnostic company provides funding for

POC clinical development in NSCLC

•

Biodesix will fund up to $15 million of the cost of the confirmatory phase 2

study in NSCLC and all companion diagnostic development costs

•

50/50 sharing of ficlatuzumab development and commercialization

expenses beyond confirmatory phase 2

•

50/50 sharing of potential profits from ficlatuzumab

•

Biodesix retains revenue from companion diagnostic

•

AVEO to lead worldwide commercialization of ficlatuzumab

–

Agreement advances ficlatuzumab with external funding while retaining

significant downstream value for AVEO

April 8, 2015

23

FOCAL Study –

Confirmatory Phase 2

April 8, 2015

24

A Phase 2, Multicenter, Randomized, Double-blind Study of

Ficlatuzumab Plus Erlotinib Versus Placebo Plus Erlotinib in Subjects Who

Have Previously Untreated Metastatic, EGFR-mutated Non-small Cell Lung

Cancer (NSCLC) and BDX004 Positive Label

1     Line

Stage

IV

NSCLC

EGFR Mutation+

BX004 Positive

ECOG PS 0 or 1

N = 86

ficlatuzumab

+

erlotinib

placebo

+

erlotinib

•

1

O

: PFS

•

2

O

: OS, ORR, Disease

Control, PK, Safety

and tolerability

st

AV-203

25

AV-203:

Superhumanized

TM

IgG1k

MAb

Inhibitor

of

ERBB3

•

Potent high affinity NRG-1/HRG binding

inhibition

–

Exclusively blocks ERBB3 signaling

–

Potential for inducing ADCC

–

Prevents NRG-1/HRG induced proliferation

–

Opportunity to explore combinations with HER2

and EGFR Targeted Therapies

•

Patent Term: 2031 (composition of matter) and

2032 (NRG-1 biomarker) with potential for

extensions

•

Biogen agreement allows for AVEO to find a

worldwide partner to fund further development

for AV-203

April 7, 2015

26

1.

Reacquired worldwide rights from Biogen Idec (March 2014)

2.

Presented Phase 1 monotherapy data showing encouraging early

support for NRG-1/HRG biomarker hypothesis (ASCO 2014)

Phase 1 AV-203 Dose-Escalation, Monotherapy Study

Completed*

•

22 subjects enrolled

–

Tumor types: 4 NSCLC (3 sq, 1 adeno); 4 CRC;

2 sq cell skin; one each ovarian, peritoneal,

SCLC, endometrioid, osteosarcoma, HCC,

pancreatic, neuroendocrine, bladder,

mesothelioma, SCCHN, cervical 

•

Recommended P2 dose is 20mg/kg every

2 weeks (maximum dose tested)

–

Most common treatment-related AEs were

diarrhea (59%), dry skin and decreased appetite

(32% each); 1 DLT observed

•

Encouraging early efficacy and

support for NRG-1/HRG biomarker

hypothesis

–

Of 22 patients, 8 SD and 1 PR

–

1 of 2 NRG-1/HRG+ patients experienced a PR

April 7, 2015

* Sarantopoulos, ASCO 2014. Abs#11113.

NSCLC with partial response (9 mg/kg)

(NRG-1/HRG Positive)

27

Combination Therapy:  AV-203 combined with both afatinib or

cetuximab could be effective in preventing resistance

April 7, 2015

28

Treatment of FaDu Xenograft with AV-203 Prevents

Resistance to Other EGFR and EGFR/HER2 Inhibitors

0.0

200.0

400.0

600.0

800.0

1000.0

1200.0

1400.0

1600.0

1800.0

2000.0

1

4

7

10

13

16

19

22

25

28

31

34

37

40

43

46

49

52

55

58

61

64

67

70

73

Study Day

PBS

Xolair 20mpk

203 20mpk

Erbitux 5mpk

Afatinib 12.5mpk

203/Erbitux Combo 20/5mpk

AV-

203/Afatinib Combo 20/12.5mpk

Last dose

AV-

AV-

AV-380

29

30

Cachexia:

Complex

metabolic

syndrome

associated with several underlying chronic

illnesses and characterized by loss of

muscle mass and strength, loss of whole

body fat, inflammation, anemia, etc.  

~400,000 pts

In US

~960,000 pts

In US

~150,000 pts

In US

~3,200,000 pts

In US

Cachexia Represents a Significant Unmet Medical Need

Cancer

Cachexia

(Wasting Syndrome)

Congestive

Heart

Failure

Chronic

Kidney

Disease

Chronic

Obstructive

Pulmonary Disease

Morley et al; Am J Clin Nutr 2006;83:735–43

GDF15 –

Driver of Cachexia (Wasting Syndrome)

31

Proof-of-Concept:

Elevated in cachectic 

models and patients

(vs. non-cachectic)

•

Administration of

GDF15 induces

cachexia

•

Inhibition of GDF15

reverses cachexia

31

GDF15 Levels –

Patient Samples

GDF15 Levels –

Murine Models

GDF15 –

Driver of Cachexia (Wasting Syndrome)

32

Proof-of-Concept:

Elevated in cachectic

models and patients

(vs. non-cachectic)

Administration of

GDF15 induces

cachexia

Inhibition of GDF15

reverses cachexia

32

GDF15 –

Driver of Cachexia (Wasting Syndrome)

33

Proof-of-Concept:

33

IgG Vehicle

Anti-mGDF15 Ab + Drug A

IgG Vehicle + Drug A

Overall Survival in Xenograft Model

In absence of anti-GDF15 antibody treatment,

the mice died due to cachexia

Inhibition of GDF15

reverses cachexia

Administration of

GDF15 induces

cachexia

Elevated in cachectic

models and patients

(vs. non-cachectic)

First-in-Class, Differentiated Approach to Cachexia

•

AV-380: Potent humanized GDF15 inhibitory MAb

–

Unique mechanism of action

•

Increase

calorie/food intake

•

Reverse

body weight loss

•

Restore

normal body composition

•

Mechanism of action different from:

–

Hormonal/Metabolic agents (i.e. ghrelin, SARMs)

•

Focus on stimulation of appetite or muscle protein synthesis

–

Muscle regulation-directed agents (i.e. myostatin, activin)

•

Address the muscle wasting aspect of the diseases

–

Early cytokine inhibitors (i.e.TNF  ,IL-6, IL-8)

•

Mechanistic link to the disease not well established

•

Strong Intellectual Property Position

–

Composition of matter patent (filed)

–

Method of use patent (granted in US and EU)

34

Financials and Summary

April 7, 2015

35

Financials Highlights

•

Streamlined operations

•

Headcount reduction from 60 to 20.  Expected to reduce annual

compensation expenses by ~$6 million

•

Reduce AVEO’s facilities requirements by up to 80% of its current

space, including the elimination of lab and vivarium needs

•

Provided termination notice for current lease; Identified new lower

cost facility in Cambridge

•

4Q14 cash and securities of $52.3M

•

Sufficient to fund operations into the third quarter of 2016

•

Shares outstanding as of 12/31/14: ~52M

36

37

AVEO

is

Poised

to

Unlock

the

Potential

of

its

Robust

Pipeline

of

Assets

by

Leveraging

Biomarkers

and

Partnerships

Substantial Ownership of all Programs

Most advanced stage of development

Streamlined Organization to Focus on

Clinical and Business Development Operations

GDF-15 Biomarker Cachexia

NRG-1 Biomarker Solid Tumors

Ocular Diseases

Potential EU File 1st line RCC

TIVO-1 Crossover  Refractory RCC

Angiogenesis Biomarkers CRC

Serum Proteomic Biomarker NSCLC

Tivozanib

VEGFR 123 TKI

Ficlatuzumab

HGF MAb

AV-203

ERBB3 MAb

AV-380

GDF15 MAb

Program

Pathway

Development

Candidate

Preclinical

Phase 1

Phase 2

Phase 3

Rights

Own ex-Asian 

rights

Wholly Owned

Wholly Owned

38

April 2015

CORP OVERVIEW