AVEO AVEO Pharmaceuticals Inc.

6.82
-0.19  -3%
Previous Close 7.01
Open 6.95
52 Week Low 3.6
52 Week High 18.24
Market Cap $234,340,486
Shares 34,360,775
Float 31,755,199
Enterprise Value $193,585,032
Volume 838,878
Av. Daily Volume 3,048,964
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Upcoming Catalysts

Drug Stage Catalyst Date
Ficlatuzumab and cetuximab
Head and neck squamous cell carcinoma (HNSCC)
Phase 2
Phase 2
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Drug Pipeline

Drug Stage Notes
Fotivda (tivozanib) iand Opdivo (nivolumab) - TiNivo-2
Renal Cell Carcinoma
Phase 3
Phase 3
Phase 3 trial planned for mid-2021.
Tivozanib
Third line treatment of patients with renal cell cancer
Approved
Approved
FDA approval announced March 10, 2021.
Ficlatuzumab and nab-paclitaxel
Pancreatic ductal adenocarcinoma (PDAC)
Phase 1b
Phase 1b
Phase 1b data noted 29% partial response (PR) rate - January 27, 2020.
FOTIVDA (Tivozanib) and IMFINZI (Durvalumab) - DEDUCTIVE
Hepatocellular carcinoma (HCC)
Phase 1/2
Phase 1/2
Phase 1/2 trial has moved to Phase 2 part of trial - May 29, 2020. Phase 1b data presented at ASCO GI January 15, 2021. 29% partial response (PR) rate.
AV-380
Healthy volunteers
Phase 1
Phase 1
Phase 1 trial has been initiated.
Ficlatuzumab and cytarabine
Acute myeloid leukemia (AML)
Phase 2
Phase 2
Phase 2 trial discontinued due to COVID-19.
Ficlatuzumab
EGFR-mutated Non-small cell lung cancer (NSCLC)
Phase 2
Phase 2
Announced September 12, 2016 that its Phase 2 trial has been discontinued

Latest News

  1. AVEO Oncology (NASDAQ:AVEO) today announced that the National Comprehensive Cancer Network (NCCN) has updated its Clinical Practice Guidelines to include FOTIVDA® (tivozanib) as a recommended regimen for subsequent therapy. The subsequent therapy category follows the first-line treatment regimen recommendations for patients with clear cell histology renal cell carcinoma (ccRCC). On March 10, 2021, the U.S. Food and Drug Administration (FDA) approved FOTIVDA for the treatment of adults with relapsed or refractory advanced renal cell carcinoma (RCC) following two or more prior systemic therapies. FOTIVDA is an oral, next-generation vascular endothelial growth factor (VEGF) tyrosine kinase inhibitor (TKI).

    "FOTIVDA's addition to the NCCN Guidelines…

    AVEO Oncology (NASDAQ:AVEO) today announced that the National Comprehensive Cancer Network (NCCN) has updated its Clinical Practice Guidelines to include FOTIVDA® (tivozanib) as a recommended regimen for subsequent therapy. The subsequent therapy category follows the first-line treatment regimen recommendations for patients with clear cell histology renal cell carcinoma (ccRCC). On March 10, 2021, the U.S. Food and Drug Administration (FDA) approved FOTIVDA for the treatment of adults with relapsed or refractory advanced renal cell carcinoma (RCC) following two or more prior systemic therapies. FOTIVDA is an oral, next-generation vascular endothelial growth factor (VEGF) tyrosine kinase inhibitor (TKI).

    "FOTIVDA's addition to the NCCN Guidelines provides further validation for its potential to serve as an important evidence-based, well tolerated treatment option for patients with relapsed or refractory advanced RCC," said Michael Bailey, president and chief executive officer of AVEO. "As previously announced, launch efforts are now underway, and we are committed to bringing this promising therapy to as many appropriate patients as possible."

    The NCCN Clinical Practice Guidelines are the recognized standard for clinical policy in cancer care and are developed through review of evidence and recommendations from physicians and oncology researchers. The current NCCN RCC guidelines categorically make treatment recommendations for first-line or subsequent therapy options for RCC patients. FOTIVDA is now recommended by the NCCN Guidelines as a subsequent therapy for patients with ccRCC who have received two or more prior systemic therapies (Category 2a). FOTIVDA's addition to the NCCN Guidelines follows its recent U.S. FDA approval, which was based on AVEO's pivotal Phase 3 study, TIVO-3, comparing FOTIVDA to sorafenib in relapsed or refractory advanced RCC following two or more prior systemic therapies. The approval was also supported by three additional trials in RCC and included safety data from over 1,000 clinical trial subjects.

    About FOTIVDA® (tivozanib)

    FOTIVDA® (tivozanib) is an oral, next-generation vascular endothelial growth factor receptor (VEGFR) tyrosine kinase inhibitor (TKI). It is a potent, selective inhibitor of VEGFRs 1, 2, and 3 with a long half-life designed to improve efficacy and tolerability. AVEO received U.S. Food and Drug Administration (FDA) approval for FOTIVDA on March 10, 2021 for the treatment of adult patients with relapsed or refractory advanced renal cell carcinoma (RCC) following two or more prior systemic therapies. FOTIVDA was approved in August 2017 in the European Union and other countries in the territory of its partner EUSA Pharma (UK) Limited for the treatment of adult patients with advanced RCC. FOTIVDA has been shown to significantly reduce regulatory T-cell production in preclinical models1. FOTIVDA was discovered by Kyowa Kirin.

    INDICATIONS

    FOTIVDA is indicated for the treatment of adult patients with relapsed or refractory advanced renal cell carcinoma (RCC) following two or more prior systemic therapies.

    IMPORTANT SAFETY INFORMATION

    WARNINGS AND PRECAUTIONS

    Hypertension and Hypertensive Crisis: Control blood pressure prior to initiating FOTIVDA. Monitor for hypertension and treat as needed. For persistent hypertension despite use of anti-hypertensive medications, reduce the FOTIVDA dose.

    Cardiac Failure: Monitor for signs or symptoms of cardiac failure throughout treatment with FOTIVDA.

    Cardiac Ischemia and Arterial Thromboembolic Events: Closely monitor patients who are at increased risk for these events. Permanently discontinue FOTIVDA for severe arterial thromboembolic events, such as myocardial infarction and stroke.

    Venous Thromboembolic Events: Closely monitor patients who are at increased risk for these events. Permanently discontinue FOTIVDA for severe venous thromboembolic events.

    Hemorrhagic Events: Closely monitor patients who are at risk for or who have a history of bleeding.

    Proteinuria: Monitor throughout treatment with FOTIVDA. For moderate to severe proteinuria, reduce the dose or temporarily interrupt treatment with FOTIVDA.

    Thyroid Dysfunction: Monitor before initiation and throughout treatment with FOTIVDA.

    Risk of Impaired Wound Healing: Withhold FOTIVDA for at least 24 days before elective surgery. Do not administer for at least 2 weeks following major surgery and adequate wound healing. The safety of resumption of FOTIVDA after resolution of wound healing complications has not been established.

    Reversible Posterior Leukoencephalopathy Syndrome (RPLS): Discontinue FOTIVDA if signs or symptoms of RPLS occur.

    Embryo-Fetal Toxicity: Can cause fetal harm. Advise patients of the potential risk to a fetus and to use effective contraception.

    Allergic Reactions to Tartrazine: The 0.89 mg capsule of FOTIVDA contains FD&C Yellow No.5 (tartrazine) which may cause allergic-type reactions (including bronchial asthma) in certain susceptible patients.

    ADVERSE REACTIONS

    The most common (≥20%) adverse reactions were fatigue, hypertension, diarrhea, decreased appetite, nausea, dysphonia, hypothyroidism, cough, and stomatitis, and the most common Grade 3 or 4 laboratory abnormalities (≥5%) were sodium decreased, lipase increased, and phosphate decreased.

    DRUG INTERACTIONS

    Strong CYP3A4 Inducers: Avoid coadministration of FOTIVDA with strong CYP3A4 inducers.

    USE IN SPECIFIC POPULATIONS

    Lactation: Advise not to breastfeed.

    Females and Males of Reproductive Potential: Can impair fertility.

    Hepatic Impairment: Adjust dosage in patients with moderate hepatic impairment. Avoid use in patients with severe hepatic impairment.

    To report SUSPECTED ADVERSE REACTIONS, contact AVEO Pharmaceuticals, Inc. at 1-833-FOTIVDA (1-833-368-4832) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

    Please see FOTIVDA Full Prescribing Information which is available at www.FOTIVDA.com.

    About Advanced Renal Cell Carcinoma

    According to the American Cancer Society's 2021 statistics, renal cell carcinoma (RCC) is the most common type of kidney cancer, which is among the ten most common cancers in both men and women. Approximately 73,750 new cases of kidney cancer will be diagnosed annually and about 14,830 people will die from this disease. In patients with late-stage disease, the five-year survival rate is 13%. Agents that target the vascular endothelial growth factor (VEGF) pathway have shown significant antitumor activity in RCC.2 According to a 2019 publication, 50% of the approximately 10,000 patients who progress following two or more lines of therapy choose not to receive further treatment,3 which may be attributable to tolerability concerns and a lack of data to support evidence-based treatment decisions in this highly relapsed or refractory patient population.

    About AVEO Pharmaceuticals, Inc.

    AVEO is an oncology-focused biopharmaceutical company committed to delivering medicines that provide a better life for cancer patients. AVEO's strategy is to focus its resources toward the development and commercialization of its product candidates in North America, while leveraging partnerships to support development and commercialization in other geographies. AVEO's lead candidate, FOTIVDA® (tivozanib), received U.S. Food and Drug Administration (FDA) approval on March 10, 2021 for the treatment of adult patients with relapsed or refractory renal cell carcinoma (RCC) following two or more prior systemic therapies. FOTIVDA® was approved in August 2017 in the European Union and other countries in the EUSA territory for the treatment of adult patients with advanced RCC. AVEO has previously reported promising early clinical data on ficlatuzumab (anti-HGF IgG1 mAb) in head and neck cancer, pancreatic cancer and acute myeloid leukemia and is conducting a randomized Phase 2 confirmatory clinical trial of ficlatuzumab for the potential treatment of head and neck cancer. AVEO's pipeline of product candidates also includes AV-380 (anti-GDF15 IgG1 mAb). AVEO has previously reported the acceptance of its investigational new drug application in the U.S. for AV-380 and its initiation of a Phase 1 clinical trial for the potential treatment of cancer cachexia. AVEO's earlier-stage pipeline includes monoclonal antibodies in oncology development, including AV-203 (anti-ErbB3 mAb) and AV-353 (anti-Notch 3 mAb). AVEO is committed to creating an environment of diversity and inclusion.

    Cautionary Note Regarding Forward-Looking Statements

    This press release contains forward-looking statements of AVEO 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 fact, contained in this press release are forward-looking statements. The words "anticipate," "believe," "design," "expect," "hope," "intend," "may," "plan," "potential," "could," "should," "would," "seek," "look forward," "advance," "goal," "strategy," 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 ability to successfully sell and distribute FOTIVDA (tivozanib) to patients in the U.S. and to ensure it is available to as many patients as possible; the potential for FOTIVDA as a treatment option for patients with relapsed or refractory advanced RCC; the potential for FOTIVDA as a subsequent therapy for patients with ccRCC as recommended by NCCN Guidelines; the potential efficacy, safety, and tolerability of tivozanib, both as a stand-alone drug candidate and in combination with other therapies in several indications; the potential of the AVEO ACE Patient Support program to make patient access to FOTIVDA simple and to offer comprehensive services to patients regardless of insurance or financial circumstances; AVEO's execution of its clinical and regulatory strategy for tivozanib; AVEO's plans and strategies for current and future clinical trials of tivozanib, ficlatuzumab and AV-380 and for commercialization of FOTIVDA in the U.S.; the advancement of AVEO's pipeline, including the advancement of ficlatuzumab in multiple clinical studies; the potential outcomes from studies of ficlatuzumab to provide AVEO with opportunities to pursue regulatory strategies; the potential clinical utility of ficlatuzumab and AV-380 in areas of unmet need and AVEO's strategy, prospects, plans and objectives for FOTIVDA and its product candidates and for AVEO generally. AVEO has based its expectations and estimates on assumptions that may prove to be incorrect. As a result, readers are cautioned not to place undue reliance on these expectations and estimates. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements that AVEO makes due to a number of important factors, including risks relating to: AVEO's ability to successfully implement its strategic plans, including its ability to successfully commercialize FOTIVDA and to obtain and maintain market and third party payor acceptance of FOTIVDA; AVEO's ability to raise the substantial additional funds required to achieve its goals, including those goals pertaining to the commercialization of FOTIVDA; AVEO's ability, and the ability of its licensees, to demonstrate to the satisfaction of applicable regulatory agencies such as the FDA the safety, efficacy, and clinically meaningful benefit of AVEO's product candidates, and risks relating to the timing and costs of seeking and obtaining regulatory approvals; AVEO's dependence on third-party vendors for the development, manufacture and supply of FOTIVDA and its product candidates; and 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; AVEO's and its collaborators' ability to successfully enroll and complete clinical trials; AVEO's ability to maintain compliance with regulatory requirements applicable to FOTIVDA and its product candidates; AVEO's ability to obtain and maintain adequate protection for intellectual property rights relating to FOTIVDA and its product candidates; unplanned capital requirements; uncertainties related to AVEO's ability to access future borrowings under the Hercules loan agreement, which turns on the achievement of milestones related to the commercialization of FOTIVDA in the U.S., which milestones may not be achieved; adverse general economic, political and industry conditions; the potential adverse effects of the COVID-19 pandemic on AVEO's business continuity, financial condition, results of operations, liquidity and ability to successfully and timely enroll, complete and read-out data from its clinical trials; competitive factors; 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 Securities and Exchange Commission (SEC) and in other filings that AVEO makes with the SEC. The forward-looking statements in this press release represent AVEO's views as of the date of this press release, and subsequent events and developments may cause its views to change. While AVEO may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so. You should, therefore, not rely on these forward-looking statements as representing AVEO's views as of any date other than the date of this press release.

    Any reference to AVEO's website address in this press release is intended to be an inactive textual reference only and not an active hyperlink.

    References

    1. Pawlowski N et al. AACR 2013. Poster 3971
    2. J Angulo and O Shapiro, Cancers (Basel) 2019 Sep; 11(9): 1227. [10.3390/cancers11091227]
    3. Decision Resources. RCC landscape and forecast. December 12, 2019.

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  2. AVEO Oncology (NASDAQ:AVEO) today announced the closing of its previously announced underwritten public offering of 6,900,000 shares of its common stock, which includes the full exercise by the underwriters of their option to purchase an additional 900,000 shares, at a price to the public of $8.00 per share. The aggregate gross proceeds to AVEO from the offering were $55.2 million, before deducting underwriting discounts and commissions and offering expenses payable by AVEO.

    The net proceeds of the offering are expected to be used for working capital and general corporate purposes, including to support commercialization activities relating to FOTIVDA® (tivozanib) and to advance AVEO's pipeline.

    SVB Leerink and Stifel acted as joint bookrunning…

    AVEO Oncology (NASDAQ:AVEO) today announced the closing of its previously announced underwritten public offering of 6,900,000 shares of its common stock, which includes the full exercise by the underwriters of their option to purchase an additional 900,000 shares, at a price to the public of $8.00 per share. The aggregate gross proceeds to AVEO from the offering were $55.2 million, before deducting underwriting discounts and commissions and offering expenses payable by AVEO.

    The net proceeds of the offering are expected to be used for working capital and general corporate purposes, including to support commercialization activities relating to FOTIVDA® (tivozanib) and to advance AVEO's pipeline.

    SVB Leerink and Stifel acted as joint bookrunning managers for the offering. Baird acted as lead manager for the offering. H.C. Wainwright & Co. and JonesTrading acted as co-managers for the offering.

    The shares were offered by AVEO pursuant to a shelf registration statement on Form S-3 that was filed with the Securities and Exchange Commission ("SEC") on November 9, 2020 and declared effective by the SEC on November 18, 2020.

    A final prospectus supplement relating to, and describing the terms of, the offering has been filed with the SEC and is available on the SEC's website at www.sec.gov.

    Copies of the final prospectus supplement and the accompanying prospectus relating to this offering may also be obtained from SVB Leerink LLC, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, MA 02110, by telephone at (800) 808-7525, ext. 6105 or by email at ; or Stifel, Nicolaus & Company, Incorporated, Attention: Syndicate, One Montgomery Street, Suite 3700, San Francisco, CA 94104, by telephone at (415) 364-2720 or by email at .

    This press release does not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

    About AVEO Pharmaceuticals, Inc.

    AVEO is an oncology-focused biopharmaceutical company committed to delivering medicines that provide a better life for cancer patients. AVEO's strategy is to focus its resources toward development and commercialization of its product candidates in North America, while leveraging partnerships to support development and commercialization in other geographies. AVEO's lead candidate, FOTIVDA® (tivozanib), received U.S. Food and Drug Administration (FDA) approval on March 10, 2021 for the treatment of adult patients with relapsed or refractory renal cell carcinoma (RCC) following two or more prior systemic therapies. FOTIVDA® was approved in August 2017 in the European Union and other countries in the EUSA territory for the treatment of adult patients with advanced RCC. AVEO has previously reported promising early clinical data on ficlatuzumab (anti-HGF IgG1 mAb) in head and neck cancer, pancreatic cancer and acute myeloid leukemia and is conducting a randomized Phase 2 confirmatory clinical trial of ficlatuzumab for the potential treatment of head and neck cancer. AVEO's pipeline of product candidates also includes AV-380 (anti-GDF15 IgG1 mAb). AVEO has previously reported the acceptance of its investigational new drug application in the U.S. for AV-380 and its initiation of a Phase 1 clinical trial for the potential treatment of cancer cachexia. AVEO's earlier-stage pipeline includes monoclonal antibodies in oncology development, including AV-203 (anti-ErbB3 mAb) and AV-353 (anti-Notch 3 mAb). AVEO is committed to creating an environment of diversity and inclusion.

    Cautionary Note Regarding Forward Looking Statements

    This press release 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 fact, contained in this press release are forward-looking statements. The words "anticipate," "believe," "estimate," "expect," "hope," "intend," "may," "plan," "potential," "could," "should," "would," "seek," "look forward," "advance," "goal," "strategy," 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 relating to the intended use of proceeds from the public offering. Actual results may differ materially from those projected or implied in these forward-looking statements. You should not place undue reliance on these forward-looking statements. Factors that may cause such a difference include, without limitation, risks and uncertainties related to the impact of general economic, industry or political conditions in the United States or internationally. Additional risks and uncertainties relating to AVEO and its business can be found under the caption "Risk Factors" included in AVEO's Annual Report on Form 10-K for the period ended December 31, 2020, AVEO's final prospectus supplement filed with the SEC on March 24, 2021, and other filings that AVEO may make with the SEC in the future. Any forward-looking statements contained in this press release speak only as of the date hereof, and AVEO expressly disclaims any obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise.

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  3. AVEO Oncology (NASDAQ:AVEO) today announced that it has priced its previously announced underwritten public offering of 6,000,000 shares of its common stock at a price to the public of $8.00 per share. The gross proceeds to AVEO from the offering are expected to be $48.0 million before deducting underwriting discounts and commissions and offering expenses. All of the shares in the offering are being sold by AVEO. AVEO has also granted the underwriters a 30-day option to purchase up to an additional 900,000 shares of common stock on the same terms and conditions. Closing of the offering is expected to occur on or about March 26, 2021, subject to satisfaction of customary closing conditions.

    The net proceeds of the offering are expected to be…

    AVEO Oncology (NASDAQ:AVEO) today announced that it has priced its previously announced underwritten public offering of 6,000,000 shares of its common stock at a price to the public of $8.00 per share. The gross proceeds to AVEO from the offering are expected to be $48.0 million before deducting underwriting discounts and commissions and offering expenses. All of the shares in the offering are being sold by AVEO. AVEO has also granted the underwriters a 30-day option to purchase up to an additional 900,000 shares of common stock on the same terms and conditions. Closing of the offering is expected to occur on or about March 26, 2021, subject to satisfaction of customary closing conditions.

    The net proceeds of the offering are expected to be used for working capital and general corporate purposes, including to support commercialization activities relating to FOTIVDA® (tivozanib) and to advance AVEO's pipeline.

    SVB Leerink and Stifel are acting as joint bookrunning managers for the offering. Baird is acting as lead manager for the offering. H.C. Wainwright & Co. and JonesTrading are acting as co-managers for the offering.

    The shares are being offered by AVEO pursuant to a shelf registration statement on Form S-3 that was filed with the Securities and Exchange Commission ("SEC") on November 9, 2020 and declared effective by the SEC on November 18, 2020. A preliminary prospectus supplement relating to, and describing the terms of, the offering has been filed with the SEC and is available on the SEC's website at www.sec.gov.

    Copies of the final prospectus supplement and the accompanying prospectus relating to this offering, when available, can be obtained from SVB Leerink LLC, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, MA 02110, by telephone at (800) 808-7525, ext. 6105 or by email at ; or Stifel, Nicolaus & Company, Incorporated, Attention: Syndicate, One Montgomery Street, Suite 3700, San Francisco, CA 94104, by telephone at (415) 364-2720 or by email at .

    This press release does not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

    About AVEO Pharmaceuticals, Inc.

    AVEO is an oncology-focused biopharmaceutical company committed to delivering medicines that provide a better life for cancer patients. AVEO's strategy is to focus its resources toward development and commercialization of its product candidates in North America, while leveraging partnerships to support development and commercialization in other geographies. AVEO's lead candidate, FOTIVDA® (tivozanib), received U.S. Food and Drug Administration (FDA) approval on March 10, 2021 for the treatment of adult patients with relapsed or refractory renal cell carcinoma (RCC) following two or more prior systemic therapies. FOTIVDA® was approved in August 2017 in the European Union and other countries in the EUSA territory for the treatment of adult patients with advanced RCC. AVEO has previously reported promising early clinical data on ficlatuzumab (anti-HGF IgG1 mAb) in head and neck cancer, pancreatic cancer and acute myeloid leukemia and is conducting a randomized Phase 2 confirmatory clinical trial of ficlatuzumab for the potential treatment of head and neck cancer. AVEO's pipeline of product candidates also includes AV-380 (anti-GDF15 IgG1 mAb). AVEO has previously reported the acceptance of its investigational new drug application in the U.S. for AV-380 and its initiation of a Phase 1 clinical trial for the potential treatment of cancer cachexia. AVEO's earlier-stage pipeline includes monoclonal antibodies in oncology development, including AV-203 (anti-ErbB3 mAb) and AV-353 (anti-Notch 3 mAb). AVEO is committed to creating an environment of diversity and inclusion.

    Cautionary Note Regarding Forward Looking Statements

    This press release 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 fact, contained in this press release are forward-looking statements. The words "anticipate," "believe," "estimate," "expect," "hope," "intend," "may," "plan," "potential," "could," "should," "would," "seek," "look forward," "advance," "goal," "strategy," 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 relating to the timing of the closing of the public offering and the intended use of proceeds therefrom. Actual results may differ materially from those projected or implied in these forward-looking statements. Factors that may cause such a difference include, without limitation, risks and uncertainties related to the satisfaction of customary closing conditions related to the public offering and the impact of general economic, industry or political conditions in the United States or internationally. There can be no assurance that AVEO will be able to complete the public offering on the anticipated terms, or at all. You should not place undue reliance on these forward-looking statements. Additional risks and uncertainties relating to the offering, AVEO and its business can be found under the caption "Risk Factors" included in AVEO's Annual Report on Form 10-K for the year ended December 31, 2020, AVEO's preliminary prospectus supplement filed with the SEC on March [•], 2021, and other filings that AVEO may make with the SEC in the future. Any forward-looking statements contained in this press release speak only as of the date hereof, and AVEO expressly disclaims any obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise.

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  4. AVEO Oncology (NASDAQ:AVEO) today announced that it has commenced an underwritten public offering of 5,000,000 shares of its common stock. In connection with the offering, AVEO intends to grant the underwriters a 30-day option to purchase up to an additional 750,000 shares of its common stock. All of the shares in the offering are to be sold by AVEO. The offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.

    The net proceeds of the offering are expected to be used for working capital and general corporate purposes, including to support commercialization activities relating to FOTIVDA® (tivozanib) and to advance…

    AVEO Oncology (NASDAQ:AVEO) today announced that it has commenced an underwritten public offering of 5,000,000 shares of its common stock. In connection with the offering, AVEO intends to grant the underwriters a 30-day option to purchase up to an additional 750,000 shares of its common stock. All of the shares in the offering are to be sold by AVEO. The offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.

    The net proceeds of the offering are expected to be used for working capital and general corporate purposes, including to support commercialization activities relating to FOTIVDA® (tivozanib) and to advance AVEO's pipeline.

    SVB Leerink and Stifel are acting as joint bookrunning managers for the offering.

    The shares are being offered by AVEO pursuant to a shelf registration statement on Form S-3 that was filed with the Securities and Exchange Commission ("SEC") on November 9, 2020 and declared effective by the SEC on November 18, 2020. A preliminary prospectus supplement relating to, and describing the terms of, the offering will be filed with the SEC and will be available on the SEC's website at www.sec.gov.

    Copies of the preliminary prospectus supplement and the accompanying prospectus relating to this offering can be obtained from SVB Leerink LLC, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, MA 02110, by telephone at (800) 808-7525, ext. 6105 or by email at ; or Stifel, Nicolaus & Company, Incorporated, Attention: Syndicate, One Montgomery Street, Suite 3700, San Francisco, CA 94104, by telephone at (415) 364-2720 or by email at . The final terms of the offering will be disclosed in a final prospectus supplement to be filed with the SEC.

    This press release does not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

    About AVEO Pharmaceuticals, Inc.

    AVEO is an oncology-focused biopharmaceutical company committed to delivering medicines that provide a better life for cancer patients. AVEO's strategy is to focus its resources toward development and commercialization of its product candidates in North America, while leveraging partnerships to support development and commercialization in other geographies. AVEO's lead candidate, FOTIVDA® (tivozanib), received U.S. Food and Drug Administration (FDA) approval on March 10, 2021 for the treatment of adult patients with relapsed or refractory renal cell carcinoma (RCC) following two or more prior systemic therapies. FOTIVDA® was approved in August 2017 in the European Union and other countries in the EUSA territory for the treatment of adult patients with advanced RCC. AVEO has previously reported promising early clinical data on ficlatuzumab (anti-HGF IgG1 mAb) in head and neck cancer, pancreatic cancer and acute myeloid leukemia and is conducting a randomized Phase 2 confirmatory clinical trial of ficlatuzumab for the potential treatment of head and neck cancer. AVEO's pipeline of product candidates also includes AV-380 (anti-GDF15 IgG1 mAb). AVEO has previously reported the acceptance of its investigational new drug application in the U.S. for AV-380 and its initiation of a Phase 1 clinical trial for the potential treatment of cancer cachexia. AVEO's earlier-stage pipeline includes monoclonal antibodies in oncology development, including AV-203 (anti-ErbB3 mAb) and AV-353 (anti-Notch 3 mAb). AVEO is committed to creating an environment of diversity and inclusion.

    Cautionary Note Regarding Forward-Looking Statements

    This press release 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 fact, contained in this press release are forward-looking statements. The words "anticipate," "believe," "estimate," "expect," "hope," "intend," "may," "plan," "potential," "could," "should," "would," "seek," "look forward," "advance," "goal," "strategy," 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 relating to AVEO's plans to consummate its proposed public offering and the intended use of proceeds therefrom. Actual results may differ materially from those projected or implied in these forward-looking statements. Factors that may cause such a difference include, without limitation, risks and uncertainties related to whether or not AVEO will be able to raise capital through the sale of shares of common stock, the final terms of the proposed offering, market and other conditions, the satisfaction of customary closing conditions related to the proposed public offering and the impact of general economic, industry or political conditions in the United States or internationally. There can be no assurance that AVEO will be able to complete the proposed public offering on the anticipated terms, or at all. You should not place undue reliance on these forward-looking statements. Additional risks and uncertainties relating to the proposed offering, AVEO and its business can be found under the caption "Risk Factors" included in AVEO's Annual Report on Form 10-K for the year ended December 31, 2020, AVEO's preliminary prospectus supplement to be filed with the SEC on March [•], 2021, and other filings that AVEO may make with the SEC in the future. Any forward-looking statements contained in this press release speak only as of the date hereof, and AVEO expressly disclaims any obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise.

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  5. - FOTIVDA is the First Therapy Approved for Adults with Relapsed or Refractory Advanced RCC Following Two or More Prior Systemic Therapies –

    - AVEO ACE Patient Support Program in Place to Assist with Access, Affordability, and Treatment Adherence -

    AVEO Oncology (NASDAQ:AVEO) today announced that FOTIVDA® (tivozanib) is now commercially available in the United States (U.S.) ahead of the previous March 31, 2021 guidance. On March 10, 2021, the U.S. Food and Drug Administration (FDA) approved FOTIVDA for the treatment of adults with relapsed or refractory advanced renal cell carcinoma (RCC) following two or more prior systemic therapies. FOTIVDA is an oral, next-generation vascular endothelial growth factor (VEGF) tyrosine kinase inhibitor…

    - FOTIVDA is the First Therapy Approved for Adults with Relapsed or Refractory Advanced RCC Following Two or More Prior Systemic Therapies –

    - AVEO ACE Patient Support Program in Place to Assist with Access, Affordability, and Treatment Adherence -

    AVEO Oncology (NASDAQ:AVEO) today announced that FOTIVDA® (tivozanib) is now commercially available in the United States (U.S.) ahead of the previous March 31, 2021 guidance. On March 10, 2021, the U.S. Food and Drug Administration (FDA) approved FOTIVDA for the treatment of adults with relapsed or refractory advanced renal cell carcinoma (RCC) following two or more prior systemic therapies. FOTIVDA is an oral, next-generation vascular endothelial growth factor (VEGF) tyrosine kinase inhibitor (TKI).

    "We are thrilled to begin bringing FOTIVDA to patients battling relapsed or refractory kidney cancer," said Michael Bailey, president and chief executive officer of AVEO. "With its differentiated tolerability and efficacy profile, FOTIVDA has the potential to serve as a meaningful, evidence-based treatment option for the population of patients who have previously received two prior lines of systemic therapy."

    "We are keenly focused on ensuring that FOTIVDA is available to as many appropriate patients as possible," said Mike Ferraresso, chief commercial officer of AVEO. "As part of this effort and our commitment to the RCC community, we have put in place an assistance program, AVEO ACE, which we believe will optimize patient access and help patients navigate their treatment journey. With the early FDA approval, the team has worked hard to make FOTIVDA available to patients as quickly as possible through our distribution partners and we believe we are well positioned for the successful launch of FOTIVDA."

    The AVEO ACE Patient Support program is designed to offer a comprehensive suite of services dedicated to providing access and personalized support to patients and their loved ones throughout the FOTIVDA treatment journey. Regardless of a patient's insurance or financial circumstances, AVEO ACE is available to connect them to resources they may need, with the goal of making access to FOTIVDA simple and streamlined. The program is committed to helping identify payor-specific prior authorizations and appeals to address patient needs, offering programs for insurance related delays, and connecting patients, regardless of insurance type, to resources that can address common access and reimbursement challenges. For more information, please call AVEO ACE at 1-833-FOTIVDA (1-833-368-4832) Monday-Friday from 8:00 AM to 8:00 PM Eastern Time.

    FOTIVDA is available through a limited distribution network comprised of specialty pharmacies (Biologics & Onco360) and specialty distributors: Amerisource Specialty Distribution, Oncology Supply, McKesson Plasma and Biologics, McKesson Specialty and Cardinal Specialty.

    About FOTIVDA® (tivozanib)

    FOTIVDA® (tivozanib) is an oral, next-generation vascular endothelial growth factor receptor (VEGFR) tyrosine kinase inhibitor (TKI). It is a potent, selective inhibitor of VEGFRs 1, 2, and 3 with a long half-life designed to improve efficacy and tolerability. AVEO received U.S. Food and Drug Administration (FDA) approval for FOTIVDA on March 10, 2021 for the treatment of adult patients with relapsed or refractory advanced renal cell carcinoma (RCC) following two or more prior systemic therapies. FOTIVDA was approved in August 2017 in the European Union and other countries in the territory of its partner EUSA Pharma (UK) Limited for the treatment of adult patients with advanced RCC. FOTIVDA has been shown to significantly reduce regulatory T-cell production in preclinical models1. FOTIVDA was discovered by Kyowa Kirin.

    INDICATIONS

    FOTIVDA is indicated for the treatment of adult patients with relapsed or refractory advanced renal cell carcinoma (RCC) following two or more prior systemic therapies.

    IMPORTANT SAFETY INFORMATION

    WARNINGS AND PRECAUTIONS

    Hypertension and Hypertensive Crisis: Control blood pressure prior to initiating FOTIVDA. Monitor for hypertension and treat as needed. For persistent hypertension despite use of anti-hypertensive medications, reduce the FOTIVDA dose.

    Cardiac Failure: Monitor for signs or symptoms of cardiac failure throughout treatment with FOTIVDA.

    Cardiac Ischemia and Arterial Thromboembolic Events: Closely monitor patients who are at increased risk for these events. Permanently discontinue FOTIVDA for severe arterial thromboembolic events, such as myocardial infarction and stroke.

    Venous Thromboembolic Events: Closely monitor patients who are at increased risk for these events. Permanently discontinue FOTIVDA for severe venous thromboembolic events.

    Hemorrhagic Events: Closely monitor patients who are at risk for or who have a history of bleeding.

    Proteinuria: Monitor throughout treatment with FOTIVDA. For moderate to severe proteinuria, reduce the dose or temporarily interrupt treatment with FOTIVDA.

    Thyroid Dysfunction: Monitor before initiation and throughout treatment with FOTIVDA.

    Risk of Impaired Wound Healing: Withhold FOTIVDA for at least 24 days before elective surgery. Do not administer for at least 2 weeks following major surgery and adequate wound healing. The safety of resumption of FOTIVDA after resolution of wound healing complications has not been established.

    Reversible Posterior Leukoencephalopathy Syndrome (RPLS): Discontinue FOTIVDA if signs or symptoms of RPLS occur.

    Embryo-Fetal Toxicity: Can cause fetal harm. Advise patients of the potential risk to a fetus and to use effective contraception.

    Allergic Reactions to Tartrazine: The 0.89 mg capsule of FOTIVDA contains FD&C Yellow No.5 (tartrazine) which may cause allergic-type reactions (including bronchial asthma) in certain susceptible patients.

    ADVERSE REACTIONS

    The most common (≥20%) adverse reactions were fatigue, hypertension, diarrhea, decreased appetite, nausea, dysphonia, hypothyroidism, cough, and stomatitis, and the most common Grade 3 or 4 laboratory abnormalities (≥5%) were sodium decreased, lipase increased, and phosphate decreased.

    DRUG INTERACTIONS

    Strong CYP3A4 Inducers: Avoid coadministration of FOTIVDA with strong CYP3A4 inducers.

    USE IN SPECIFIC POPULATIONS

    Lactation: Advise not to breastfeed.

    Females and Males of Reproductive Potential: Can impair fertility.

    Hepatic Impairment: Adjust dosage in patients with moderate hepatic impairment. Avoid use in patients with severe hepatic impairment.

    To report SUSPECTED ADVERSE REACTIONS, contact AVEO Pharmaceuticals, Inc. at 1-833-FOTIVDA (1-833-368-4832) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

    Please see FOTIVDA Full Prescribing Information which is available at www.FOTIVDA.com.

    About Advanced Renal Cell Carcinoma

    According to the American Cancer Society's 2021 statistics, renal cell carcinoma (RCC) is the most common type of kidney cancer, which is among the ten most common cancers in both men and women. Approximately 73,750 new cases of kidney cancer will be diagnosed annually and about 14,830 people will die from this disease. In patients with late-stage disease, the five-year survival rate is 13%. Agents that target the vascular endothelial growth factor (VEGF) pathway have shown significant antitumor activity in RCC.2 According to a 2019 publication, 50% of the approximately 10,000 patients who progress following two or more lines of therapy choose not to receive further treatment,3 which may be attributable to tolerability concerns and a lack of data to support evidence-based treatment decisions in this highly relapsed or refractory patient population.

    About AVEO Pharmaceuticals, Inc.

    AVEO is an oncology-focused biopharmaceutical company committed to delivering medicines that provide a better life for cancer patients. AVEO's strategy is to focus its resources toward the development and commercialization of its product candidates in North America, while leveraging partnerships to support development and commercialization in other geographies. AVEO's lead candidate, FOTIVDA® (tivozanib), received U.S. Food and Drug Administration (FDA) approval on March 10, 2021 for the treatment of adult patients with relapsed or refractory renal cell carcinoma (RCC) following two or more prior systemic therapies. FOTIVDA® was approved in August 2017 in the European Union and other countries in the EUSA territory for the treatment of adult patients with advanced RCC. AVEO has previously reported promising early clinical data on ficlatuzumab (anti-HGF IgG1 mAb) in head and neck cancer, pancreatic cancer and acute myeloid leukemia and is conducting a randomized Phase 2 confirmatory clinical trial of ficlatuzumab for the potential treatment of head and neck cancer. AVEO's pipeline of product candidates also includes AV-380 (anti-GDF15 IgG1 mAb). AVEO has previously reported the acceptance of its investigational new drug application in the U.S. for AV-380 and its initiation of a Phase 1 clinical trial for the potential treatment of cancer cachexia. AVEO's earlier-stage pipeline includes monoclonal antibodies in oncology development, including AV-203 (anti-ErbB3 mAb) and AV-353 (anti-Notch 3 mAb). AVEO is committed to creating an environment of diversity and inclusion.

    Cautionary Note Regarding Forward-Looking Statements

    This press release contains forward-looking statements of AVEO 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 fact, contained in this press release are forward-looking statements. The words "anticipate," "believe," "design," "expect," "hope," "intend," "may," "plan," "potential," "could," "should," "would," "seek," "look forward," "advance," "goal," "strategy," 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 planned timing for making FOTIVDA available to patients in the U.S and efforts to ensure it is available to as many patients as possible; the potential for FOTIVDA as a treatment option for patients with relapsed or refractory advanced RCC; the potential efficacy, safety, and tolerability of tivozanib, both as a stand-alone drug candidate and in combination with other therapies in several indications; the potential of the AVEO ACE Patient Support program to make patient access to FOTIVDA simple and to offer comprehensive services to patients regardless of insurance or financial circumstances; AVEO's execution of its clinical and regulatory strategy for tivozanib; AVEO's plans and strategies for current and future clinical trials of tivozanib, ficlatuzumab and AV-380 and for commercialization of FOTIVDA in the United States; the advancement of AVEO's pipeline, including the advancement of ficlatuzumab in multiple clinical studies; the potential outcomes from studies of ficlatuzumab to provide AVEO with opportunities to pursue regulatory strategies; the potential clinical utility of ficlatuzumab and AV-380 in areas of unmet need and AVEO's strategy, prospects, plans and objectives for FOTIVDA and its product candidates and for AVEO generally. AVEO has based its expectations and estimates on assumptions that may prove to be incorrect. As a result, readers are cautioned not to place undue reliance on these expectations and estimates. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements that AVEO makes due to a number of important factors, including risks relating to: AVEO's ability to successfully implement its strategic plans, including its ability to successfully commercialize FOTIVDA and to obtain and maintain market and third party payor acceptance of FOTIVDA; AVEO's ability to raise the substantial additional funds required to achieve its goals, including those goals pertaining to the commercialization of FOTIVDA; AVEO's ability, and the ability of its licensees, to demonstrate to the satisfaction of applicable regulatory agencies such as the FDA the safety, efficacy, and clinically meaningful benefit of AVEO's product candidates, and risks relating to the timing and costs of seeking and obtaining regulatory approvals; AVEO's dependence on third-party vendors for the development, manufacture and supply of FOTIVDA and its product candidates; and 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; AVEO's and its collaborators' ability to successfully enroll and complete clinical trials; AVEO's ability to maintain compliance with regulatory requirements applicable to FOTIVDA and its product candidates; AVEO's ability to obtain and maintain adequate protection for intellectual property rights relating to FOTIVDA and its product candidates; unplanned capital requirements; uncertainties related to AVEO's ability to access future borrowings under the Hercules loan agreement, which turns on the achievement of milestones related to the commercialization of FOTIVDA in the U.S., which milestones may not be achieved; adverse general economic, political and industry conditions; the potential adverse effects of the COVID-19 pandemic on AVEO's business continuity, financial condition, results of operations, liquidity and ability to successfully and timely enroll, complete and read-out data from its clinical trials; competitive factors; 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 Securities and Exchange Commission (SEC) and in other filings that AVEO makes with the SEC. The forward-looking statements in this press release represent AVEO's views as of the date of this press release, and subsequent events and developments may cause its views to change. While AVEO may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so. You should, therefore, not rely on these forward-looking statements as representing AVEO's views as of any date other than the date of this press release.

    Any reference to AVEO's website address in this press release is intended to be an inactive textual reference only and not an active hyperlink.

    References

    1. Pawlowski N et al. AACR 2013. Poster 3971
    2. J Angulo and O Shapiro, Cancers (Basel) 2019 Sep; 11(9): 1227. [10.3390/cancers11091227]
    3. Decision Resources. RCC landscape and forecast. December 12, 2019.

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