EX-99.1 2 d794634dex991.htm EX-99.1 EX-99.1

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AVEO Overview October 2019 Exhibit 99 .1

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Cautionary Note Regarding Forward-Looking Statements This presentation contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 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,” “seek,” “look forward,” “advance,” “goal,” “strategy,” “promising,” “opportunity” 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 goals and business strategy, prospects, plans and objectives; AVEO’s plans regarding communications with, and potentially submitting a new drug application (NDA) to the U.S. Food and Drug Administration (FDA) for tivozanib; the timing, design and results of preclinical and clinical trials, including AVEO’s plans, and expectations regarding the results of overall survival analyses for the Phase 3 TIVO-3 study of tivozanib in RCC; the timing and outcome of meetings with and applications to regulatory authorities by AVEO and its partners; the competitive landscape for, and the potential utility of, AVEO’s product candidates, AVEO’s statements regarding the potential efficacy, safety and tolerability profile of tivozanib, including with respect to overall survival; the potential commercial opportunity of tivozanib and AVEO’s other product candidates 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, and the ability of its licensees, to demonstrate to the satisfaction of applicable regulatory agencies such as the FDA and the EMA the safety, efficacy and clinically meaningful benefit of AVEO’s product candidates, including, in particular, tivozanib; AVEO’s ability to successfully file an NDA for tivozanib; AVEO’s and its collaborators’ ability to successfully enroll and complete clinical trials; AVEO’s ability to enter into and maintain its third party collaboration and license agreements, and its ability, and the ability of its strategic partners, to achieve development and commercialization objectives under these arrangements; the timing and costs of seeking and obtaining regulatory approval; AVEO’s ability to maintain compliance with regulatory requirements applicable to its product candidates; AVEO’s ability to obtain and maintain adequate protection for intellectual property rights relating to its product candidates; AVEO’s ability to successfully implement its strategic plans; AVEO’s ability to raise the substantial additional funds required to achieve its goals, including those goals pertaining to the development and commercialization of tivozanib; unplanned capital requirements; adverse general economic and industry conditions; and those risks discussed in the sections titled “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations—Liquidity and Capital Resources” included in AVEO’s quarterly and annual reports on file with the SEC and in other filings that AVEO may make with the SEC in the future. All forward-looking statements contained in this presentation speak only as of the date of this presentation, and AVEO undertakes no obligation, and specifically disclaims any obligation, to update any of these statements, except as required by law.

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AVEO Oncology: Strategy for Value Creation Value Enhancing Partnerships Deep Pipeline Addressing Significant Unmet Needs Multiple oncology and non-oncology pipeline opportunities FOTIVDA® (tivozanib) – IO Combinations (RCC, HCC, other) Selective VEGFR TKI has potential to enable unique tolerability in combination FOTIVDA® (tivozanib) – Monotherapy (RCC) Differentiated VEGFR TKI has potential to deliver unsurpassed efficacy AND favorable tolerability Partnerships advance programs and provide capital

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Clinical Preclinical Phase 1 Phase 2 Phase 3 Regulatory Filing Marketed Partner Tivozanib (RCC) VEGFR 123 TKI Tivozanib (HCC) VEGFR 123 TKI Ficlatuzumab HGF MAb AV-203 (CAN017) ERBB3 MAb Multiple Potential Opportunities for Value Creation TIVO-1 (Phase 3 Registration Study in 1st Line RCC) TIVO-3 (Phase 3 Registration Study in 3rd Line RCC) TiNivo (+OPDIVO® RCC) SCCHN (Ficla +/- ERBITUX®) Esophageal Pre-Clinical Tivozanib VEGFR 123 TKI AV-380 GDF15 MAb AV-353 Notch 3 MAb Cachexia Oncology DEDUCTIVE (1st line HCC+ IMFINZI®) Ongoing or complete In Planning (Europe) CyFi-2 (HiDac +/- Ficla AML) Pancreatic (Ficla + Nab-paclitaxel + Gemcitabine) Non-Oncology

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Financial Highlights Cash on hand to fund planned operations into 3Q 2021* $40.2M in cash, cash equivalents, and marketable securities as of 2Q 2019 $25.0M upfront payment from Kyowa Kirin received in 3Q 2019 Kyowa Kirin buy back of tivozanib non-oncology rights: $25.0M upfront payment Waiver of the $18.0M potential payment due to Kyowa Kirin upon an AVEO U.S. approval for tivozanib $391.0M in potential development and commercial milestones Tiered high single-digit to low double-digit royalties on tivozanib net sales in non-oncologic indications EUSA royalties and potential milestones: Tiered low double-digit to mid-twenties royalties on FOTIVDA® (tivozanib) net sales in Europe, Latin America, Africa, and Australia $6.0M in potential reimbursement and regulatory approval milestones $20.0M in R&D reimbursement for access to TIVO-3 data, if optioned $335.0M in potential tiered commercial milestones Approximately $32.0 million ATM availability through SVB Leerink sales agreement Streamlined, experienced team with a headcount of ~20 *This estimate excludes, subject to our decision whether to submit a New Drug Application (NDA) for tivozanib to the U.S. Food and Drug Administration (FDA), remaining costs to prepare and filing fees in connection with a possible NDA submission, and pre-commercialization activities that we may undertake. This estimate also assumes no receipt of additional milestone payments from our partners, no funding from new partnership agreements, no additional equity financings, no debt financings, no additional sales of equity under our sales agreement with SVB Leerink and no additional sales of equity through the exercise of our outstanding warrants. Accordingly, the timing and nature of activities contemplated for the remainder of 2019 and thereafter will be conducted subject to the availability of sufficient financial resources.

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FOTIVDA® (tivozanib) TIVO-3 Pivotal Phase 3 Study

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Tivozanib: VEGFR 1, 2 and 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 toxicities1,2 1 Nakamura K et al. Cancer Res 2006;66:9134–9142. 2 Eskens FA et al. Clin Cancer Res 2011;17:7156–7163.

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TIVO-3: Study Design N = 350 F Recurrent/metastatic RCC Failed at least two prior regimens including VEGFR-TKI Stratified by prior regimen (TKI-TKI; TKI-PD1; TKI-Other) ECOG PS 0 or 1 RANDOMIZE 1:1 tivozanib sorafenib 1O: PFS 2O: OS, ORR, DoR, Safety and Tolerability for ITT 60% 3rd line patients, 40% 4th line+ Phase 3, Randomized, Controlled, Multi-Center, Open-Label Study to Compare Tivozanib to Sorafenib in Subjects With Refractory Advanced Renal Cell Carcinoma First stratified 3rd line dataset of patients with prior PD-1 exposure

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TIVO-3: Superior PFS and ORR

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Progression-Free Survival – Key Subgroups* *Final analysis, as of Oct 4, 2018 Tivozanib Sorafenib Tivozanib Sorafenib Porta et al. ASCO 2019

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Treatment-Related Adverse Events* (≥20% frequency in either arm) Tivozanib (N=173)^ Sorafenib (N=170)^ Preferred Term All Grades % Grade 3/4 % All Grades % Grade 3/4 % Treatment Related AEs 84 44 94 55 Hypertension 36 20 25 14 Diarrhea 33 2 50 9 Fatigue 29 4 19 5 Decreased Appetite 26 4 21 2 Dysphonia 24 1 8 0 Asthenia 21 5 17 4 PPE** 16 1 38 10 Rash 4 0 24 8 >5% difference between arms *Analysis as of Oct 4, 2018 **Palmar-plantar erythrodysesthesia syndrome, also know as hand-foot syndrome ^Safety population

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Tivozanib (N=173)^ Sorafenib (N=170)^ Mean Number of Cycles Initiated 10.3 6.3 AEs Leading to Dose Reductions (%) 24 38 AEs Leading to Dose Interruption (%) 48 63 Treatment Related SAEs (%) 11 10 Treatment Related Deaths (%) 0 0 Deaths within 30 days of Tx (N) 15 12 Exposure Adj Deaths per Month of Tx** 0.93% 1.21% Tolerability Results* *Analysis as of Oct 4, 2018 **Exposure Adj Deaths Based on 48,656 tivozanib Tx days and 29,883 sorafenib Tx days through 10/4/2018 data cut ^Safety population P=0.005 P=0.007

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Patients Benefiting Most from Tivozanib Were Underrepresented in Preliminary OS Analysis 2yr PFS 18% 5% 28% 1yr PFS 11% TIVO-3 PFS Curve (ITT) 72% of OS events in preliminary analysis from patients with <4 months of PFS (Oct 4, 2018 Data Cut)

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Secondary Endpoint – Overall Survival Initial OS Analysis (Oct 4, 2018): HR* >1.00 Analysis based on 183 OS events Prespecified OS Analysis Update (Aug 15, 2019): HR*=0.99 Analysis based on 227 OS events 95% CI: 0.76-1.29; p=0.95 44 additional events since Oct 4, 2018 data cut 16 tivozanib events and 28 sorafenib events Total survival events 114 tivozanib and 113 sorafenib Median OS: tivozanib=16.4 mo (95% CI: 13.4-22.2), sorafenib=19.7 mo (15.0-24.2)** 20 tivozanib patients progression free and on study and 2 sorafenib patients *Hazard Ratio (HR): assesses the relative risk of death for the entirety of the dataset **Median OS: point in time value separating the earlier half of events from the latter half within each arm

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TIVO-3 Conclusions Tivozanib significantly improves PFS and ORR compared to sorafenib in patients with treatment-refractory advanced RCC Tivozanib was superior in patients previously treated with checkpoint inhibitors as well as two VEGFR-TKIs Responses with tivozanib were more durable than sorafenib Tivozanib was well tolerated, with hypertension as the most common AE Lower rates of hand-foot syndrome, diarrhea, and rash were observed for tivozanib compared to sorafenib OS hazard ratio less than 1 in updated analysis (Aug 15, 2019) 20 tivozanib patients progression free and on study vs. 2 sorafenib patients Company plans to discuss updated OS results with the FDA

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PD-1 Combination Opportunities

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Tivozanib Properties May Provide Advantages in Combination with IO Therapy Nakamura K et al. Cancer Res 2006;66:9134–9142. Pawlowski N et al. AACR 2013. Poster 3971. Hammers, Emerging VEGF-I/O Combinations, ASCO 2017

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Phase 2 Data Presented at ESMO in September 2019 Tivozanib (1.0 mg/day) QD/21 days + nivolumab 240 mg Q2 weeks N = 6 ECOG PS ≤ 1 and life expectancy ≥ 3 months Tivozanib (1.5 mg/day) QD/21 days + nivolumab 240 mg Q2 weeks Tivozanib (1.5 mg/day) QD/21 days + nivolumab 240mg Q2 weeks Phase 1 Phase 2 N = 22 ECOG PS ≤ 1 and life expectancy ≥ 3 months A Phase 1/2, Open-Label, Multi-Center Study of Tivozanib in Combination with Nivolumab (OPDIVO®) in Subjects with Advanced Renal Cell Carcinoma (TiNivo) 1o safety, tolerability, and maximum tolerated dose 2o antineoplastic activity Further evaluation of safety and antineoplastic activity Full dose and schedule selected for Phase 2

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ESMO 2019: Encouraging Safety Results Hypertension (52%) is the most common grade 3/4 AE Only 17% of patients required a dose reduction Barthelemy et al. ESMO 2019

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ESMO 2019: Encouraging Efficacy 56% ORR and 96% DCR 72% had tumor shrinkage ≥ 25% 4% of patients had a complete response mPFS of 18.9 months Results suggest additive or synergistic efficacy for tivozanib + PD-1 Barthelemy et al. ESMO 2019

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Combination of PD-1 + VEGF TKIs: Promising Responses, All Phase 3 Currently 1st Line Efficacy N (%) Tivozanib + Nivolumab1 Total N=25 Pembro + Lenvatinib2 Total N=30 Cabo + Nivo or IpiNivo3 Total N=13 Axitinib + Pembro4 Total N=52 Axitinib + Avel5 Phase 3 Total N=442 (ITT) Axitinib + Pembro6 Total N=432 CR 1 (4) 0 (0) 0 (0) 4 (8) (3) (6) PR 13 (52) 20 (67) 7 (54) 34 (65) (48) (54) ORR 14 (56) 20 (67) 7 (54) 38 (73) (51) (60) PFS 18.9 mo 18.0 mo 18.4 mo 20.9 mo 13.8 mo 15.1 mo Dose Reductions 17% 73% Not Reported 62% 42% 20% 50% Pre-treated 100% Pre-treated 60% Pre-treated Treatment Naive Treatment Naive Treatment Naive Note: Data from separate studies 1. Barthelemy, et al. Tivozanib Combined With Nivolumab: Phase Ib/II Study in mRCC, ESMO 2019; 2. Lee, et al. A Phase 1b/2 Trial of Lenvatinib + Pembrolizumab in Patients With Renal Cell Carcinoma, ASCO 2018; 3. Nadal, et al. Ph1 study of cabozantinib + nivolumab (CaboNivo) alone or with ipilumimab (CaboNivoIpi) in GU tumors , ASCO GU 2018; 4. Atkins, et al., Axitinib in combination with pembrolizumab in patients with advanced renal cell cancer: a non-randomised, open-label, dose-finding, and dose-expansion phase 1b trial, The Lancet Oncology, Volume 0 , Issue 0; 5. Motzer, et al. 1st line avelumab + axitinib therapy in patients with aRCC: Ph3, ESMO 2018; 6. Powles, et al., Pembroliumab plus axitinib vs Sunitinib as First Line Therapy in RCC: KEYNOTE 426, ASCO GU 2019

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TiNivo – Strong Efficacy Seen in Both Treatment Naive and Previously Treated Patients Treatment Naïve (12) Pre-Treated (13*) Overall (25) CR 8% - 4% PR 42% 62% 52% SD 42% 38% 40% PD 8% - 4% ORR (CR+PR) 50% 62% 56% DCR (CR+PR+SD) 92% 100% 96% mPFS 18.9 mo (4.7, NR) NR (11.0, NR) 18.9 mo (16.4, NR) TX Ongoing 33% 31% 32% *Includes 2 prior IO Pts Nivolumab Mono2 Tivozanib Mono1 ORR 18% PFS 11.0 ORR 21.5% PFS 4.2 + Second Line** Molina et al. EJC 2018 McDermott et al. ASCO 2018 **Data from separate studies

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Immuno-Oncology Clinical Collaboration with AstraZeneca Clinical Rationale:  Single agent activity demonstrated for tivozanib and durvalumab in HCC2,3.  Combination of two agents has potential to show enhanced efficacy and tolerability profile among TKI/IO regimens. Planned Phase 1/2 study: Costs shared equally and clinical drug supplied by each company HCC Market – Key Opportunity1 1 Decision Resources HCC Disease Landscape and Forecast – Dec 2018 2 Lee S et al, ASCO GI 2018 3 Wainberg et al, ASCO 2017

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Tivozanib Commercial Opportunity

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If Approved, Significant Potential Commercial Opportunity for Tivozanib in the United States 1st Line Market (est. 2020) ~$1.6B1 2nd Line Market (est. 2020) ~$700M1 3rd Line+ Market (est. 2020) ~$300M1 Expect opportunity to expand Potential to be first agent indicated for 3rd & 4th line Only pivotal dataset in RCC stratified by prior PD-1 NA royalties to KHK are low- to mid-teens on net sales 1 Decision Resources Pharmacor 2020 Market Projections July 2019 Extended OS from IO may expand population eligible for 3rd line treatment 2 1 >PFS with tivozanib may extend treatment duration 65%1 50%1 Efficacy + tolerability may increase patients opting for 3rd and 4th line treatment 1st Line 2nd Line 3rd Line 3 Composition of matter patent into 2022 with potential for extension into 2027 for both Europe and North America 4th Line 25%1

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Potential Relevance of Tivozanib in Refractory RCC Source: AVEO blinded Third-Party U.S. Oncologist Market Research using approximate TIVO-3 PFS and AE profile - Dec 2018 n=100 Treatments with proven efficacy are needed for patients who have failed 2 or more lines of treatment for RCC I prefer using drugs that do not often require me to adjust or interrupt dose due to patient tolerability issues Blinded Tivo Profile Ratings compared to current treatment options in refractory patients Likelihood to Prescribe 67% 80% Not at all likely Neutral Extremely Likely

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First-line treatment for patients with good or intermediate risk Second-line patients following TKIs Launched in Germany, Spain and UK Approved in New Zealand https://www.esmo.org/Guidelines/Genitourinary-Cancers/Renal-Cell-Carcinoma FOTIVDA® Commercialization in EU and ROW This Photo by Unknown Author is licensed under CC BY-SA ESMO Guidelines updated to include FOTIVDA® (tivozanib)1 – Feb 2019 Launched in 3 of the EU5 Countries (each launch triggers $2.0M milestone) $20.0M in R&D reimbursement for access to TIVO-3 data, if optioned $335.0M in potential tiered commercial milestones Tiered low double-digit to mid-twenties royalties on FOTIVDA® (tivozanib) net sales in Europe, Latin America, Africa, and Australia Approved in 1 of 5 non-EU countries (3 of 5 triggers $2.0M milestone) KKC entitled to 30% of all royalties and milestones, a portion of R&D reimbursement is excluded

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Pipeline and Near-Term Milestones

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Tivozanib * Does not include potential PTE up to 5 yr max VEGFR 1, 2 and 3 Tyrosine Kinase Inhibitor Launched in Europe by EUSA as FOTIVDA® in first line RCC in November 2017 TIVO-3 study on-going for potential U.S. registration for RCC Tivozanib + OPDIVO® Phase 1/2 in collaboration with BMS complete in RCC Tivozanib + IMFINZI® Phase 1/2 in collaboration with AZ open for enrollment in HCC AVEO retains milestones and royalties for non-oncology indications in key markets Composition of Matter (COM) and other IP to at least 2022* Potential Tivozanib (VEGFR 1, 2 and 3 TKI) Milestones 2H19 1H20 2H20 OS Update / Regulatory Discussion HCC Ph 1/2 (Durvalumab + Tivo) Initiation RCC Phase 1/2 (Nivolumab + Tivo) Final PFS Presentation ü ü

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Ficlatuzumab * Does not include potential PTE up to 5 yr max HGF Inhibitory Antibody with Optimal Blockade of c-Met AML: Phase 1/2 trial of ficlatuzumab and cytarabine in refractory AML patients (n=18) Demonstrated 50% CR in patients refractory to initial therapy Randomized Phase 2 in planning SCCHN: Randomized Phase 2 trial ongoing (Ficlatuzumab +/- ERBITUX®) Pancreatic Cancer: Phase 1/2 trial ongoing (Ficlatuzumab + Nab-paclitaxel + Gemcitabine) Composition of Matter (COM) and other IP to at least 2027* Potential Ficlatuzumab (HGF Inhibitory Antibody) Milestones 2H19 1H20 2H20 AML Randomized Ph2 POC (HiDAC +/- Ficlatuzumab) Initiation Pancreatic Ph 1/2 (Ficlatuzumab + Nab-paclitaxel + Gemcitabine) Presentation SCCHN Randomized (Ficlatuzumab +/- ERBITUX®) Ph2 POC Data

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Anti-ERBB3 Mab with Broad Therapeutic Potential CANbridge to fund clinical development through Phase 2 POC study Potential additional $40.0M development and regulatory/$90.0M commercial milestone Tiered low double-digit royalties for ex-NA rights Planned indication: squamous cell esophageal cancer (IND accepted in China August 2018) Composition of Matter (COM) and other IP ranging from 2031 to 2032* CAN017 (AV-203) * Does not include potential PTE up to 5 yr max Potential CAN017 (AV-203) (Anti-ERBB3 MAb) Milestones 2H19 1H20 2H20 Squamous Cell Esophageal Cancer Ph 1/2 Study Initiation

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First-in-Class, Anti-GDF15 MAb for Cachexia Cachexia affects approximately 5 million patients in the U.S. alone; affects up to 80% of advanced cancer patients and is responsible for approximately 30% of all cancer deaths1,2 Pre-clinical development underway to enable planned IND submission in 2020 Composition of Matter (COM) through at least 2033* and in-licensed methods of use patent AV-380 Morley et al; Am J Clin Nutr 2006;83:735– 43 Lerner, et al. MAP3K11/GDF15 axis is a critical driver of cancer cachexia, J Cachexia Sarcopenia Muscle. 2016 Sep; 7(4): 467–482. * Does not include potential PTE up to 5 yr max Potential AV-380 (Inhibitory Antibody Targeting GDF15) Milestones 2H19 1H20 2H20 AV-380 IND Submission

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AVEO Key Near Term Potential Milestones Tivozanib (VEGFR 1, 2 and 3 TKI) 2H19 1H20 2H20 TIVO-3 OS Update / Regulatory Discussion DEDUCTIVE HCC Ph 1/2 (Durvalumab + Tivo) Initiation TiNivo RCC (Nivolumab + Tivo) Final PFS Presentation Ficlatuzumab (HGF Inhibitory Antibody) 2H19 1H20 2H20 AML Randomized Ph2 POC (HiDAC +/- Ficlatuzumab) Initiation Pancreatic Ph 1/2 (Ficlatuzumab + Nab-paclitaxel + Gemcitabine) Presentation SCCHN Randomized (Ficlatuzumab +/- ERBITUX®) Ph2 POC Data CAN017 (AV-203) (Anti-ERBB3 MAb) 2H19 1H20 2H20 Squamous Cell Esophageal Cancer Ph 1/2 Study Initiation AV-380 (Inhibitory Antibody Targeting GDF15) 2H19 1H20 2H20 AV-380 IND Submission ü ü

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AVEO Overview October 2019