Aveo Pharmaceuticals (AVEO) 8-K AVEO Oncology Reports Full Year 2013 Financial Results

2014 Strategic Plan

MARCH 13, 2014

1

Exhibit 99.2

Forward-Looking Statements

This presentation contains forward-looking statements that involve substantial risks and uncertainties. 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 estimates for its 2014 year-end cash balance and cash

estimates through 2015; AVEO’s goals and business strategy and its ability to optimize its resources; its

approach to treat cachexia, including the potential therapeutic advantages and benefits of its AV-380

program and the potential opportunities for the treatment of cachexia beyond cancer; the timing and

results of preclinical and clinical trials; and AVEO’s plans to pursue strategic partnerships for certain of its

assets.

Actual

results

or

events

could

differ

materially

from

the

plans,

intentions

and

expectations

disclosed

in

the

forward-looking

statements

we

make

due

to

a

number

of

important

factors,

including

risks

and

uncertainties

relating

to:

our

ability

to

successfully

develop,

test

and

gain

regulatory

approval

of

our

product candidates; our ability to obtain necessary financing; our ability to establish and maintain new

strategic partnerships; our ability to obtain, maintain and enforce intellectual property rights; competition;

our dependence on our strategic partners and other third parties; adverse economic conditions; and those

risk factors discussed in the “Risk Factors”

and elsewhere in our Annual Report on Form 10-K that was

filed

with

the

Securities

and

Exchange

Commission

(“SEC”)

on

March

13,

2014,

and

other

periodic

filings

we

make

with

the

SEC.

All

forward-looking

statements

contained

in

this

presentation

speak

only

as

of

the

date

of

this

presentation,

and

we

undertake

no

obligation

to

update

any

of

these

statements,

except

as required by law.

2

Focus over the last 8 months

•

Strengthen balance sheet

•

Re-assess internal pipeline assets

•

Develop forward strategy

3

Strengthened Balance Sheet

•

Reduce cash burn

–

Headcount reduction

•

Restructuring of 62% implemented in June 2013

•

Additional ~10% reduction over last 6 months as tivozanib-related

activities wind down

–

Operating expenses run rate cut by half:

•

R&D expenses by 51% (4Q2013 vs 4Q2012)

•

G&A expenses by 52% (4Q2013 vs 4Q2012)

•

Year end 2013 financial results

–

$118.5M in cash, cash equivalents and marketable securities

–

Nimble organization leveraging external resources to complement

internal capabilities

•

Enabling execution of our forward strategy

–

Anticipated 2014 yearend cash of $50-55M

•

Projection does not including potential for additional capital from

business development or other strategic initiatives

4

Assessment of Our Internal Pipeline

•

Tivozanib

–

Discontinued studies of tivozanib in colorectal and triple negative breast

cancers

–

Astellas partnership terminated

•

Ficlatuzumab

–

Identified a biomarker for select patients with non-small cell lung cancer

(NSCLC) who potentially benefit from combination of ficlatuzumab

with

an approved EGFR TKI

•

AV-203

–

Completed Phase 1 dose escalation study

•

AV-380

–

Initiated development for first-in-class program targeting GDF-15

5

Developed AVEO’s Forward Strategy

Strategy

•

–

Address diseases where no other therapies exist and/or where

there is a well-defined patient population with clear unmet

medical needs

–

Provide clear path to proof-of-concept and approval with

reasonable probabilities of success

–

Pursue programs that can deliver value within projected financial

framework

•

6

Focus internal resources (human, platform and financial) to

advance potential first-in-class opportunities

Utilize external resources via collaborations to develop clinical

stage assets

A Strategy Based on AVEO’s Core Values

Leveraging our innovative science

and unique biological insights to

meaningfully impact the lives of

people with cancer

March 13, 2014

7

A Strategy Focused on Value Creation

Value

Creation

Internal

Resources

GDF-15 Platform

Tivozanib

AV-203

Ficlatuzumab

Partnering

Additional  Opportunistic  Strategic  Initiatives

Clinical Stage Assets

Value to be Realized through

Partnerships

9

AV-203: ErbB3 Inhibitory Antibody

March 13, 2014

10

Phase 1 dose-escalation study completed; AV-203 well-tolerated

and recommended Phase 2 dose identified

CLIA validation completed for patient selection biomarker with

response observed in biomarker positive patients

Data to be presented at 2014 medical meeting

Single agent expansion cohort discontinued

Pursue external collaboration to advance clinical development

subject to our ability to regain certain rights from Biogen Idec

Clinical

Status

Development

Plans

Ficlatuzumab: c-Met/HGF Inhibitory Antibody

March 13, 2014

11

Clinical

Status

Development

Plans

•

Phase 2 study of ficlatuzumab in combination with gefitinib vs.

gefitinib monotherapy in NSCLC completed in 2012

•

Exploratory analysis identified a patient subpopulation

deriving

benefit

from

ficlatuzumab

-

EGFR

TKI

combination

using commercial serum-based molecular diagnostic test

•

Data to be presented in 2014 medical meeting

•

Ongoing evaluation of external collaboration opportunities to

advanceclinical development

Tivozanib: Triple VEGFR Inhibitory Small Molecule

March 13, 2014

12

Clinical

Status

Development

Plans

Wind down discontinued trials of tivozanib in RCC, colorectal and triple

negative breast cancers

150 patients elected to remain on study (primarily RCC & CRC)

Remaining

committed

costs

shared

50/50

with

Astellas

(AVEO

costs

of ~$12M in 2014)

Biomarker data from CRC study to be presented at 2014 medical

meeting

Continue support for on-going ISTs

Regain worldwide rights in August 2014 following Astellas agreement

termination

Evaluate external collaboration to advance clinical

development

AV-380 in Cachexia

A Major Opportunity

13

What is Cachexia and Who Does it Affect?

14

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.  

% prevalence of weight loss by tumor¹

1.

Laviano A and

Meguid MM; Nutrition 1996; 12:358-37

2.

Morley et al; Am J Clin Nutr 2006

~400,000 cancer cachexia

patients in 7 major markets

2

GDF-15 –

Key Mediator of Cancer Induced Cachexia

•

Discovered

through

AVEO’s

Human

Response

Platform

TM

–

Key

tumor

signaling

pathway

identified

whose

activation

triggers

a

genetic

program

that

results in cachexia

–

GDF-15 identified as the key mediator

–

GDF-15 is a soluble factor found in serum/plasma; it is a divergent member of the TGF-

beta family

•

Significant experimental validation links GDF-15 to the onset of cachexia

Correlation

1,2

-

elevated levels of plasma GDF-15 correlate with the cachexia

phenotype in animal models and in cancer patients

Gain of function

1,2

-

elevated circulating GDF-15 levels cause cachexia in animal

models

Loss of function

3

-

inhibition of GDF-15 reverses body weight loss in cachectic tumor

models

•

Exclusive worldwide IP position

–

Composition

of

Matter

Pending

–

valid

until

2033

–

Method of Treating Certain Symptoms Associated with Cachexia

•

US Patent  issued –

valid until 2029

•

EU Application Pending –

valid until 2025

15

1. Johnen H et al. (2007): Nature Medicine, 13: 1333-1340

2. AVEO data presented at 2013 Cancer Cachexia Conference, 2013 AACR Annual Meeting

3. AVEO data to be presented at scientific meeting in 2014

AV-380 –

A First-in-Class Opportunity

•

AV-380: Potent humanized GDF-15 inhibitory

Mab

–

Unique mechanism of action that addresses

multiple, key underlying mechanisms of

cachexia with the potential to

•

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

16

Dodson et al; Ann Rev Med, 2011

AV380

17

AV-380

Congestive

Heart

Failure

Cancer

Chronic

Kidney

Disease

Chronic

Obstructive

Pulmonary Disease

Potential Beyond Cancer Cachexia

~5M patients suffering from muscle wasting in the U.S.

1

Initial Focus

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

43

Additional Cachexia Opportunities

Cancer

Cancer

17

AV-380 –

Program Status

•

Development initiated in Q3, 2013

•

2014 program goals

–

Completion of GMP manufacturing (Q3)

–

Pre-IND meeting to garner FDA feedback on POC development

plan (Q4)

–

Evaluate opportunities to realize value beyond cancer cachexia

•

IND planned for 2H, 2015

18

Additional Opportunistic

Strategic Initiatives

19

Value Creation through Additional Strategic Initiatives

Continue to evaluate opportunities to leverage existing

financial resources and/or internal capabilities to

•

–

clear unmet medical need

–

clear path to POC and approval

–

value inflection points within defined financial parameters

•

March 13, 2014

20

Acquire/in-license compound that meets our strategic criteria

Accelerate value creation opportunities

Summary

21

Focused

Deployment of Resources to Create Value

•

Invest:

–

AV-380

•

Continue to advance development toward IND by 2H, 2015

•

Evaluate external opportunities to realize value beyond cancer

•

Partner:

–

AV-203

•

Pursue external collaborations to advance clinical development, subject to

our ability to regain certain rights from Biogen Idec

–

Ficlatuzumab

•

Evaluate external collaborations to advance clinical development

–

Tivozanib

•

Wind down tivozanib studies and regain rights from Astellas 

•

Evaluate external collaborations for further development

•

Evaluate

–

Additional strategic initiatives -

access compounds with potential to

further accelerate value creation

22

Financially

strong

with

cash

runway

to

support

current

operating

plan