8-K

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

 

 

FORM 8-K

 

 

CURRENT REPORT

Pursuant to Section 13 or 15(d)

of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): July 6, 2020

 

 

AVEO Pharmaceuticals, Inc.

(Exact Name of Registrant as Specified in Charter)

 

 

 

Delaware   001-34655   04-3581650

(State or Other Jurisdiction

of Incorporation)

 

(Commission

File Number)

 

(IRS Employer

Identification No.)

 

30 Winter Street

Boston, Massachusetts

  02108
(Address of Principal Executive Offices)   (Zip Code)

Registrant’s telephone number, including area code: (857) 400-0101

 

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):

 

Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

 

Title of each class

 

Trading

Symbol(s)

 

Name of each exchange

on which registered

Common Stock, $0.001 par value   AVEO   Nasdaq Capital Market

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

Emerging growth company  ☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.  ☐

 

 

 


Item 7.01.

Regulation FD.

From time to time, we conduct meetings with third parties in which we utilize corporate slide presentations. A copy of our Pipeline Overview presentation is attached as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference. This presentation may be utilized in conjunction with our Corporate Overview presentation to provide additional information regarding our pipeline assets, including ficlatuzumab and AV-380.

We may amend or update the information in this slide presentation at any time and from time to time through another Current Report on Form 8-K, a later company filing, or other means.

The information in this Item 7.01 and in Exhibit 99.1 shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”) or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such a filing.

 

Item 9.01.

Financial Statements and Exhibits.

 

(d)

Exhibits

 

99.1    Pipeline Overview slide presentation, dated July 2020


SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

    AVEO Pharmaceuticals, Inc.
Date: July 6, 2020    
    By:  

/s/ Michael Bailey

      Michael Bailey
      President and Chief Executive Officer
EX-99.1

Slide 1

Passionately pursuing a better life for patients with cancer July 2020 Pipeline Overview Exhibit 99.1


Slide 2

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; the timing, design and results of preclinical and clinical trials; 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 AVEO’s product candidates; and the potential commercial opportunity of AVEO’s product candidates. 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; AVEO’s and its collaborators’ ability to successfully enroll and complete clinical trials; the impacts of the COVID-19 pandemic on AVEO’s clinical trials, business and operations; 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.


Slide 3

Clinical Preclinical Phase 1 Phase 2 Phase 3 Regulatory Filing Marketed Partner Tivozanib (RCC) VEGFR TKI Tivozanib (HCC) VEGFR TKI Ficlatuzumab Anti-HGF/c-MET mAb AV-203 (CAN017) Anti-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) HNSCC (Ficla +/- ERBITUX®) Oncology Pre-Clinical Tivozanib VEGFR TKI AV-380 Anti-GDF15 mAb AV-353 Anti-Notch 3 mAb Cachexia Oncology DEDUCTIVE (1st line HCC+ IMFINZI®) (Europe) Pancreatic (Ficla + Nab-paclitaxel + Gemcitabine) Non-Oncology CyFi-1 (AML HiDac +/- Ficla)


Slide 4

Ficlatuzumab Anti-HGF/c-MET mAb


Slide 5

Ficlatuzumab: A Potent anti-HGF/c-MET mAb Hepatocyte growth factor (HGF) pathway is frequently dysregulated in a broad range of human cancers HGF can lead to both tumor growth and metastatic progression of cancer cells when dysregulated and is an escape mechanism to CT and targeted therapies, including EGFR inhibitors Ficlatuzumab has demonstrated differentiated inhibition of HGF High affinity (pM) and slow off-rate for HGF High potency (nM) inhibiting all biological activities of HGF, including autocrine/paracrine activation loops Partnered with 1. Christensen JG, et al. Cancer Letters. 225:1-26. 2. Engelman JA, et al. Science. 316:1039-43. 3. Turke AB, et al. Cancer Cell. 17:77-88. 4. Yano S, et al. Cancer Res. 68:9479-87.


Slide 6

HNSCC: Randomized Phase 2 Trial Ongoing (Ficlatuzumab + Erbitux vs. Ficlatuzumab) Promising Phase 1 data - ASCO 2017 Topline Phase 2 data expected in 2021 AML: Randomized Phase 2 Trial On Hold Due to COVID-19 (Ficlatuzumab + Cytarabine vs. Ficlatuzumab) Promising Phase 1/2 data - AACR 2019 Pancreatic Cancer: Phase 1/2 Trial (Ficlatuzumab + Nab-paclitaxel + Gemcitabine) Topline data reported ASCO GI 2020 Ficlatuzumab: Recently Completed and Ongoing Studies in Multiple Tumor Types with Potential to Address Significant Unmet Needs *Source: NIH 2020 SEER Cancer Stats


Slide 7

Ficlatuzumab: Head & Neck Cancer (HNSCC)


Slide 8

Ficlatuzumab: Rationale in HNSCC HGF levels elevated in HNSCC tumor tissue ASCO 2017 Poster


Slide 9

Ficlatuzumab + Cetuximab: Phase 1 HNSCC Study Results in Cetuximab-Resistant Patients Combination was well tolerated with promising activity (ORR 17%, PFS 6mo, OS 8.2mo) ASCO 2017 Poster


Slide 10

Ficlatuzumab: Phase 2 Confirmatory Study Currently Enrolling Cetuximab-Resistant Patients Due to CPI 1st line approvals study is recruiting 3rd line pts after CPI and Erbitux failures. Results expected 2021 * IRB Requiring Prior IO *


Slide 11

Ficlatuzumab: Acute Myeloid Leukemia (AML)


Slide 12

Ficlatuzumab: Rationale in AML ASCO Poster 2017


Slide 13

All enrolled patients experienced induction failure to 1st line treatment where 25-30% CR rate expected from chemo alone Ficlatuzumab CyFi-1 Study: 50% CR Rate in Difficult to Treat AML Population ASCO Poster 2017


Slide 14

Ficlatuzumab: Pancreatic Cancer


Slide 15

Combination showed durable treatment responses Significant overlapping edema, study with alternate chemotherapy combo to be considered when new clinical supply is available ASCO GI Poster 2020


Slide 16

The c-Met-HGF axis promotes aberrant tumor cell growth, migration, proliferation, and angiogenesis Abnormal signaling results from c-Met over-expression, amplification or mutation of the c-Met receptor, or HGF over-expression C-Met expression is associated with expression of immunoregulatory proteins (PD-L1, IDO, IFN-g) that suppress the immune response Limited pre-clinical and clinical data suggest inhibition of c-Met signaling has direct and indirect anti-tumor effects via attenuation of immunosuppression in the tumor microenvironment Checkpoint inhibitors are less effective in tumors with driver mutations, such as c-Met; combination regimens with targeted agents may provide effective concurrent therapies Front Oncol 2020;10:54 Ficlatuzumab: Immunotherapy Combination Opportunities Emerging


Slide 17

Ficlatuzumab Summary Potential Ficlatuzumab (HGF MAb) Milestones 1H 20 2H 20 2021 HNSCC Randomized (Ficlatuzumab +/- ERBITUX®) Ph2 Confirmatory Data Pancreatic (Ficlatuzumab + Nab-paclitaxel + Gemcitabine) Ph1/2 Presentation AML CyFi-2 Randomized (DTIC +/- Ficlatuzumab) Ph2 Study Start HNSCC: Randomized Phase 2 trial ongoing (Ficlatuzumab +/- ERBITUX®) Pancreatic Cancer: Phase 1/2 trial complete (Ficlatuzumab + Nab-paclitaxel + Gemcitabine) AML: Phase 1 trial complete (Ficlatuzumab+DTIC) Explore other combinations with scientific rationale: Checkpoint Inhibitors Expected exclusivity in U.S. into 2033* * Composition of matter to 2028 and a potential 5-year PTE ü On Hold Due to COVID-19


Slide 18

AV-380 Anti-GDF15 mAb


Slide 19

Cancer Cachexia Impacts Patients Across a Broad Range of Tumor Types Cachexia is a complex metabolic syndrome associated with reduced food intake, muscle and adipose tissue loss, inflammation and anemia Approximately 50% of people with cancer will suffer from cachexia* Approximately 30% of all cancer patients die from cachexia* GDF15 is a key driver in cancer cachexia: GDF15 is elevated in cachexic models/ patients (vs. non-cachexic) Expression of GDF15 induces cachexia Inhibition of GDF15 reverses cachexia in animal models Managing cachexia has the potential to improve OS AVEO Market Research * J. Cachexia, Sarcopenia and Muscle 2010


Slide 20

Greater Than 70% of Cancer Patients Have Increased GDF15 Expression, Starting at the Pre-Cachectic Stage ** *** ** In collaboration with A Vigano % Patients Cancer Non-Cachexia Pre-cachexia Cachexia Refractory Cachexia GDF15 < 2.0 (ng/mL) 51% 29% 30% 21% GDF15 > 2.0 (ng/mL) 49% 71% 70% 79% GDF15 Distribution Across Patient Samples Average GDF15 in Patient Samples Adjusted by tumor stage, GDF15 expression is the top factor that predicts cachexia stage with significance


Slide 21

Tumors Engineered to Overexpress GDF15 Cause Severe Weight Loss, Inhibition of GDF15 Reverses the Cachexia Phenotype Induced by Tumor Inhibition of GDF15 Reverses Cachexia in Animal Models 2mpk mIgG 2mpk anti-mGDF15 Ab Expression of GDF15 Induces Cachexia in Animal Models Lerner et al., (2016), J. of Cachexia, Sarcopenia and Muscle, 7: 467-482


Slide 22

GDF15 Has Been Shown to Predict Survival in Cancer Patients Survival analysis showed that GDF15 expression predicted survival adjusting for stage and weight change 1st quartile (low) 2nd quartile 3rd quartile 4th quartile (High) Percent Survival Days In collaboration with A. Vigano


Slide 23

Increased GDF15 protein expression found in airway epithelium (mainly in ciliated cells) of human COPD smokers compared with normal non-smokers1 Cigarette smoke exposure consistently up-regulated GDF15 expression in human airway epithelial cells1 Significant Market Opportunities Outside of Cancer* AVEO has conducted additional analyses of patient samples and animal models to examine the role of GDF15 in cachexia outside of cancer COPD >5x Larger than Cancer Cachexia Market Congestive Heart Failure 2x Larger than Cancer Cachexia Market GDF-15 Levels Predict Mortality in CHF2 Wu, Q et al. Innate Immunity 0(0), 16 Dec 2011 Kempf et al. & Wollert. JACC, 2007 *Partnership opportunity for non-oncology rights


Slide 24

AV-380 Development and Exclusivity Program Development Status – Focused on Cancer Cachexia AV-380 is currently in preclinical development AVEO preparing IND for planned 2020 filing Intellectual Property Estate Method of use patent through 2029 to cover increasing body weight (e.g., treating cachexia) by inhibiting GDF15 Composition of matter on AV-380 antibodies through 2033


Slide 25

Key Potential Clinical and Regulatory Milestones AV-380 (Anti-GDF15 mAb) 1H 20 2H 20 2021 AV-380 IND Submission for Cancer Cachexia CAN017 (AV-203) (Anti-ERBB3 mAb) 1H 20 2H 20 2021 Initiate POC Study upon NRG1 Fusion Biomarker Evaluation Ficlatuzumab (Anti-HGF/c-MET mAb) 1H 20 2H 20 2021 HNSCC (Ficlatuzumab +/- ERBITUX®) Randomized Ph2 POC Data Pancreatic (Ficlatuzumab + Nab-paclitaxel + Gemcitabine) Ph1/2 Presentation ü Tivozanib (VEGFR 123 TKI) 1H 20 2H 20 2021 PDUFA Date (R/R RCC) Final OS HCC Ph1/2 (Durvalumab + Tivo) Ph2 HCC Ph1/2 (Durvalumab + Tivo) Ph1 ü ü Tivozanib (VEGFR 123 TKI, Non Oncology) 1H 20 2H 20 2021 Regulatory/Development Milestone


Slide 26

Passionately pursuing a better life for patients with cancer July 2020 Pipeline Overview