AVEO AVEO Pharmaceuticals Inc.

5.68
+0.09  (+2%)
Previous Close 5.59
Open 5.58
52 Week Low 2.2301
52 Week High 10.71
Market Cap $146,591,229
Shares 25,808,315
Float 23,202,739
Enterprise Value $92,877,058
Volume 93,569
Av. Daily Volume 451,820
Stock charts supplied by TradingView

Upcoming Catalysts

Drug Stage Catalyst Date
Tivozanib
Third line treatment of patients with renal cell cancer
PDUFA
PDUFA
Premium membership is required to view catalyst dates, analyst ratings, earnings dates and cash burn data. Click here to unlock and sign up to a 14-day FREE TRIAL.
Ficlatuzumab and cetuximab
Head and neck squamous cell carcinoma (HNSCC)
Phase 2
Phase 2
Lorem ipsum dolor sit amet, consectetur adipiscing elit. Quisque sapien.

Drug Pipeline

Drug Stage Notes
FOTIVDA (Tivozanib) and IMFINZI (Durvalumab)
Hepatocellular carcinoma (HCC)
Phase 1/2
Phase 1/2
Phase 1/2 trial has moved to Phase 2 part of trial - May 29, 2020.
Ficlatuzumab and cytarabine
Acute myeloid leukemia (AML)
Phase 2
Phase 2
Phase 2 trial discontinued due to COVID-19.
Ficlatuzumab and nab-paclitaxel
Pancreatic ductal adenocarcinoma (PDAC)
Phase 1b
Phase 1b
Phase 1b data noted 29% partial response (PR) rate - January 27, 2020.
Tivozanib + Opdivo
Renal cell cancer (RCC)
Phase 2
Phase 2
Phase 2 final data presented at ESMO 2019.
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 the appointment of David Crist as Vice President of Sales. In this role, Mr. Crist will be responsible for building out AVEO's sales force in anticipation of the potential approval and launch of tivozanib, the Company's next-generation vascular endothelial growth factor receptor tyrosine kinase inhibitor (VEGFR-TKI), as a treatment for relapsed or refractory renal cell carcinoma.

    "We are excited to welcome David to the AVEO team as we continue to prepare for the potential commercial launch of tivozanib in the U.S.," said Mike Ferraresso, senior vice president, business analytics and commercial operations of AVEO. "David's proven track record of success and deep experience with the launch and growth…

    AVEO Oncology (NASDAQ:AVEO) today announced the appointment of David Crist as Vice President of Sales. In this role, Mr. Crist will be responsible for building out AVEO's sales force in anticipation of the potential approval and launch of tivozanib, the Company's next-generation vascular endothelial growth factor receptor tyrosine kinase inhibitor (VEGFR-TKI), as a treatment for relapsed or refractory renal cell carcinoma.

    "We are excited to welcome David to the AVEO team as we continue to prepare for the potential commercial launch of tivozanib in the U.S.," said Mike Ferraresso, senior vice president, business analytics and commercial operations of AVEO. "David's proven track record of success and deep experience with the launch and growth of new oncology therapies will play an important role in the success of our commercial strategy and team. Our commercial team and I look forward to working closely with him throughout this process."

    "I am pleased to join AVEO during this transformational period for the Company, as it prepares for the potential launch of tivozanib in the U.S.," said Mr. Crist. "I believe that tivozanib has the potential to be an important new treatment option for patients with relapsed or refractory renal cell carcinoma with what would be the first evidence-based roadmap for treatment decisions in the third-plus-line setting, including for patients receiving earlier-line immunotherapy. I look forward to working alongside this talented team as AVEO moves toward the potential commercialization of tivozanib in the U.S."

    Mr. Crist brings more than twenty years of oncology sales experience in both launch-stage and late-stage companies, building commercial organizations and developing high performing sales force teams. During his career, Mr. Crist held oncology-focused sales roles at several leading pharmaceutical companies including MGI (Molecular Genetics, Inc), Eisai, Sanofi Genzyme, GlaxoSmithKline and ARIAD Pharmaceuticals, where he led their sales organization in the successful relaunch of ICLUSIG® (ponatinib), which contributed to the acquisition of ARIAD by Takeda Oncology in 2017. Following the acquisition, he continued at Takeda to successfully launch ALUNBRIG® (brigatinib), which exceeded launch year and subsequent year forecasts nationally. Directly prior to joining AVEO, Mr. Crist served as general manager, hematology oncology U.S. franchise at argenx, a global immunology company, where he led commercial development for two of the company's hematology and oncology compounds. Mr. Crist holds a B.S. from Florida State University.

    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, tivozanib is approved as FOTIVDA® in the European Union and other countries in the EUSA territory for the treatment of adult patients with advanced renal cell carcinoma. AVEO is working to develop and potentially commercialize tivozanib in the U.S. as a treatment for renal cell carcinoma and hepatocellular carcinoma. AVEO has previously reported promising early clinical data on ficlatuzumab (anti-HGF mAb) in head and neck cancer, acute myeloid leukemia and pancreatic cancer and is conducting a randomized Phase 2 confirmatory clinical trial of ficlatuzumab in head and neck cancer. AVEO's earlier-stage pipeline includes several monoclonal antibodies in oncology development, including AV-203 (anti-ErbB3 mAb), AV-380 (anti-GDF15 mAb) and AV-353 (anti-Notch 3 mAb). AVEO is committed to creating an environment of diversity and inclusion as a foundation for innovation.

    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," "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: the potential for tivozanib as a treatment option for patients with advanced HCC or relapsed/refractory or advanced RCC; the potential efficacy, safety, and tolerability of tivozanib, both as a stand-alone drug candidate and in combination with immunotherapy; 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 tivozanib in the United States; and AVEO's strategy, prospects, plans and objectives for its product candidates and for the Company 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: whether the results of TIVO-3 are sufficient to obtain marketing approval for tivozanib in the U.S., which turns on the ability of AVEO to demonstrate to the satisfaction of the FDA the safety and efficacy of tivozanib based upon the findings of TIVO-3, including its data with respect to PFS, the rate of adverse events, OS and other information that the FDA may consider to be relevant to an approval determination; 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, including, in particular, tivozanib and ficlatuzumab; 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 faces other risks relating to its business as well, including risks relating to the timing and costs of seeking and obtaining regulatory approval; AVEO's and its collaborators' ability to successfully enroll and complete clinical trials; 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, including its ability to successfully launch and commercialize tivozanib if it may be approved for commercialization by the FDA; 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; AVEO's ability to access future borrowings under the Hercules loan facility, which turns on the achievement of milestones related to the approval and commercialization of tivozanib in the U.S., which milestones may not be achieved; adverse general economic 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.

    View Full Article Hide Full Article
  2. AVEO Oncology (NASDAQ:AVEO) today announced that final overall survival (OS) results from its Phase 3 TIVO-3 study were published in the journal European Urology. TIVO-3 is the Company's pivotal Phase 3 trial comparing tivozanib, AVEO's next-generation vascular endothelial growth factor (VEGF) receptor tyrosine kinase inhibitor (TKI) drug candidate, to sorafenib in third and fourth line renal cell carcinoma (RCC). The article, titled "Final Overall Survival Results from a Phase 3 Study to Compare Tivozanib to Sorafenib as Third- or Fourth-line Therapy in Subjects with Metastatic Renal Cell Carcinoma," is available online first via this link.

    "TIVO-3 represents the first positive superiority study in the growing population of patients who have…

    AVEO Oncology (NASDAQ:AVEO) today announced that final overall survival (OS) results from its Phase 3 TIVO-3 study were published in the journal European Urology. TIVO-3 is the Company's pivotal Phase 3 trial comparing tivozanib, AVEO's next-generation vascular endothelial growth factor (VEGF) receptor tyrosine kinase inhibitor (TKI) drug candidate, to sorafenib in third and fourth line renal cell carcinoma (RCC). The article, titled "Final Overall Survival Results from a Phase 3 Study to Compare Tivozanib to Sorafenib as Third- or Fourth-line Therapy in Subjects with Metastatic Renal Cell Carcinoma," is available online first via this link.

    "TIVO-3 represents the first positive superiority study in the growing population of patients who have relapsed or become refractory to multiple lines of therapy, including checkpoint inhibitors," said Sumanta (Monty) Pal, MD, Associate Clinical Professor, Department of Medical Oncology and Therapeutics Research, and Co-director, Kidney Cancer Program, at City of Hope Comprehensive Cancer Center, and lead author. "TIVO-3 data suggest a favorable safety and efficacy profile relative to sorafenib as demonstrated by superior anti-tumor progression free survival and overall response activity vs. another VEGFR TKI, coupled with fewer dose reductions, interruptions and discontinuations. The OS hazard ratio (HR) is consistent with previous Phase 3 studies comparing two VEGF-directed agents. I believe that tivozanib has the potential to offer patients a meaningful new treatment option in a setting currently lacking an evidence-based standard of care."

    "For RCC patients who have relapsed or are refractory to multiple lines of therapy, the lack of well controlled clinical data to guide treatment decisions in this advanced relapsed/refractory population poses challenges for patients and treating physicians," said Michael Bailey, president and chief executive officer of AVEO. "We expect that Tivozanib's TIVO-3 data has the potential to guide important treatment decisions in this setting and ultimately improve outcomes and patient experience. We look forward to working with the U.S. Food and Drug Administration (FDA) as they continue to review our New Drug Application (NDA) submission."

    In June 2020, AVEO announced that the FDA accepted for filing its NDA seeking approval for tivozanib as a treatment for relapsed or refractory RCC. The FDA has assigned the application standard review and a Prescription Drug User Fee Act target action date of March 31, 2021. The FDA also indicated that they do not currently plan on convening an Oncologic Drug Advisory Committee (ODAC) to discuss the application. The NDA submission is based on the TIVO-3 study and is also supported by three additional trials in RCC and includes safety data from over 1,000 clinical trial subjects and several years of commercial availability in Europe.

    Results in Detail

    Patients enrolled in the TIVO-3 trial (n=350) were randomized and stratified by prior regimen and IMDC prognostic score. Prior treatment regimens included prior checkpoint inhibitor and VEGF TKI therapies (n=91), two prior VEGF TKI therapies (n=159) and prior VEGF TKI and other therapies (n=100). As previously announced, the TIVO-3 trial met the primary endpoint of progression free survival (PFS), with a median PFS of 5.6 months in the tivozanib arm vs. 3.9 months in the sorafenib arm (HR=0.73; p=0.02), and the secondary endpoint of overall response rate (ORR) (18% vs. 8%; p=0.02).

    For the secondary endpoint of OS, the OS HR, which assesses the overall relative risk of death, was 0.97 (95% CI: 0.75-1.24; p=0.82), favoring tivozanib and improving from the previously reported interim HR of 0.99. Median OS, representing a single point in time in the OS curve, was 16.4 months for tivozanib (95% CI: 13.4-22.2) and 19.2 months for sorafenib (95% CI: 15.0-24.2). These OS HR results are similar to those of prior VEGFR TKI vs. VEGFR TKI studies in RCC.1-4

    Tivozanib was found to be generally well-tolerated, with grade 3 or higher adverse events (AEs) consistent with those observed in previous tivozanib trials. The most common AE in patients receiving tivozanib was hypertension (38% vs. 25% for sorafenib, of treated patients), an AE known to reflect effective VEGF pathway inhibition. Infrequent but severe AEs reported in greater number in the tivozanib arm were thrombotic events (5% vs. 4% for sorafenib, of treated patients) similar to those observed in previous tivozanib studies. Dose reductions and interruptions due to AEs were significantly lower for tivozanib vs. sorafenib, despite nearly double the average number of cycles initiated for the tivozanib arm (11.9 months vs. 6.7 months for sorafenib), and treatment related AEs leading to permanent discontinuation were 8% for tivozanib vs. 15% for sorafenib.

    About Tivozanib (FOTIVDA®)

    Tivozanib is an oral, once-daily, next-generation vascular endothelial growth factor receptor (VEGFR) tyrosine kinase inhibitor (TKI) discovered by Kyowa Kirin and approved as FOTIVDA® for the treatment of adult patients with advanced renal cell carcinoma (RCC) in the European Union and other countries in the EUSA territory. It is a potent, selective and long half-life inhibitor of all three VEGF receptors and is designed to optimize VEGF blockade while minimizing off-target toxicities, potentially resulting in improved efficacy and minimal dose modifications.5,6 Tivozanib is being studied in the TIVO-3 trial, which is supporting a regulatory submission of tivozanib in the U.S. seeking marketing approval as a treatment for relapsed or refractory RCC. Tivozanib has been shown to significantly reduce regulatory T-cell production in preclinical models7 and has demonstrated synergy in combination with nivolumab (anti PD-1) in a Phase 2 study in RCC.8 Tivozanib has been investigated in several tumor types, including renal cell, hepatocellular, colorectal, ovarian and breast cancers. Tivozanib is also being studied by partner Kyowa Kirin in non-oncology indications.

    About AVEO Pharmaceuticals, Inc.

    AVEO is developing an oncology pipeline that is being designed to provide a better life for patients with cancer. 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, tivozanib is approved as FOTIVDA® in the European Union and other countries in the EUSA territory for the treatment of adult patients with advanced renal cell carcinoma. AVEO is working to develop and potentially commercialize tivozanib in North America as a treatment for renal cell carcinoma and hepatocellular carcinoma. AVEO has previously reported promising early clinical data on ficlatuzumab (anti-HGF mAb) in head and neck cancer, acute myeloid leukemia and pancreatic cancer and is conducting a randomized Phase 2 confirmatory clinical trial of ficlatuzumab in head and neck cancer. AVEO's earlier-stage pipeline includes several monoclonal antibodies in oncology development, including AV-203 (anti-ErbB3 mAb), AV-380 (anti-GDF15 mAb) and AV-353 (anti-Notch 3 mAb). AVEO is committed to creating an environment of diversity and inclusion as a foundation for innovation.

    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," "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: the potential for tivozanib as a treatment option for patients with advanced HCC or relapsed/refractory or 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; 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 tivozanib in the United States; and AVEO's strategy, prospects, plans and objectives for its product candidates and for the Company 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: whether the results of TIVO-3 are sufficient to obtain marketing approval for tivozanib in the U.S., which turns on the ability of AVEO to demonstrate to the satisfaction of the FDA the safety and efficacy of tivozanib based upon the findings of TIVO-3, including its data with respect to PFS, the rate of adverse events, OS and other information that the FDA may consider to be relevant to an approval determination; 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, including, in particular, tivozanib and ficlatuzumab; 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 faces other risks relating to its business as well, including risks relating to the timing and costs of seeking and obtaining regulatory approval; AVEO's and its collaborators' ability to successfully enroll and complete clinical trials; 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, including its ability to successfully launch and commercialize tivozanib if it may be approved for commercialization by the FDA; 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; AVEO's ability to access future borrowings under the Hercules loan facility, which turns on the achievement of milestones related to the approval and commercialization of tivozanib in the U.S., which milestones may not be achieved; adverse general economic 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. Hutson et al. Clinical Genitourinary Cancer; Vol. 15, No. 1, 72-6
    2. Choueiri et al. European Journal of Cancer 2018; 94: 115-125
    3. Motzer et. al. Lancet Oncol 2013; 14: 552–62
    4. Motzer, et al. N Engl J Med. 2014;370(18):1769-1770
    5. Fotivda (Tivozanib) SmPC August 2017
    6. Motzer RJ, Nosov D, Eisen T, et al. J Clin Oncol 2013; 31(30): 3791-9
    7. Pawlowski N et al. AACR 2013. Poster 3971
    8. Barthelemy et al. ESMO 2018. Poster 878P

     

    View Full Article Hide Full Article
  3. Announces Decision to Fund Clinical Manufacture of Ficlatuzumab for Potential Phase 3 Study and Update to Biodesix Partnership

    No Change to AVEO Cash Runway Guidance

    AVEO Oncology (NASDAQ:AVEO) today announced that it has regained full global rights to ficlatuzumab, AVEO's potent hepatocyte growth factor (HGF) inhibitory antibody which binds to the HGF ligand with high affinity and specificity to inhibit HGF/c-Met biological activities. AVEO also announced today that it plans to fund the clinical manufacture of ficlatuzumab to enable a potential registrational Phase 3 clinical trial in head and neck squamous cell cancer (HNSCC), as well as additional potential development in Phase 2 studies in pancreatic cancer and acute myeloid leukemia…

    Announces Decision to Fund Clinical Manufacture of Ficlatuzumab for Potential Phase 3 Study and Update to Biodesix Partnership

    No Change to AVEO Cash Runway Guidance

    AVEO Oncology (NASDAQ:AVEO) today announced that it has regained full global rights to ficlatuzumab, AVEO's potent hepatocyte growth factor (HGF) inhibitory antibody which binds to the HGF ligand with high affinity and specificity to inhibit HGF/c-Met biological activities. AVEO also announced today that it plans to fund the clinical manufacture of ficlatuzumab to enable a potential registrational Phase 3 clinical trial in head and neck squamous cell cancer (HNSCC), as well as additional potential development in Phase 2 studies in pancreatic cancer and acute myeloid leukemia (AML). Following the decision, Biodesix, a leading diagnostic company, has exercised its contractual right to reduce its future financial obligations in exchange for reduced partnership economics. Under the terms of the agreement between AVEO and Biodesix, Biodesix will continue to fund 50% of the ongoing HNSCC Phase 2 trial, and will be entitled to a low double digit royalty on any future product sales as well as 25% of future licensing revenue, subject to certain limitations.

    "We are very pleased to regain full rights to another late-stage asset. This comes at a strategic point in our Company's history, as we continue to build a commercial biopharmaceutical company with a broad oncology portfolio that has the potential to enable a long-term, sustainable growth model," said Michael Bailey, president and chief executive officer of AVEO. "The early data we have seen in the randomized, open-label HNSCC study with ficlatuzumab combined with cetuximab (ERBITUX®) has led us to the decision to secure additional clinical manufacturing capacity, which we expect to fund within our previously announced cash runway guidance, in order to prepare for a potential HNSCC pivotal study. We look forward to presenting final results from the Phase 2 study in the middle of 2021, and to providing an update on our potential pivotal program within that timeframe."

    Ficlatuzumab is being studied in an ongoing randomized, open-label confirmatory Phase 2 study in combination with cetuximab, an EGFR-targeted antibody, in cetuximab-resistant, recurrent metastatic HNSCC. The study was designed to confirm findings from a Phase 1 study of ficlatuzumab and cetuximab where the combination was well tolerated and resulted in a disease control rate of 67%, as well as prolonged progression free and overall survival compared to historical controls. The Phase 2 multi-center study is being conducted under the direction of Julie E. Bauman, MD, MPH, Professor of Medicine, Chief, Division of Hematology/Oncology, Associate Director of Translational Research, University of Arizona Cancer Center. Enrollment is expected to conclude in the fourth quarter of 2020, and results from the study are expected to be presented at a scientific meeting in 2021.

    For more information, please refer to the Current Report on Form 8-K which will be filed by AVEO with the U.S. Securities & Exchange Commission on September 8, 2020.

    About AVEO Pharmaceuticals, Inc.

    AVEO is developing an oncology pipeline designed to provide a better life for patients with cancer. 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, tivozanib (FOTIVDA®) is approved in the European Union and other countries in the EUSA territory for the treatment of adult patients with advanced renal cell carcinoma. AVEO is working to develop and potentially commercialize tivozanib in North America as a treatment for renal cell carcinoma and hepatocellular carcinoma. AVEO has previously reported promising early clinical data on ficlatuzumab (anti-HGF mAb) in head and neck cancer, acute myeloid leukemia and pancreatic cancer and is conducting a randomized Phase 2 confirmatory clinical trial of ficlatuzumab in head and neck cancer. AVEO's earlier-stage pipeline includes several monoclonal antibodies in oncology development, including AV-203 (anti-ErbB3 mAb), AV-380 (anti-GDF15 mAb) and AV-353 (anti-Notch 3 mAb). AVEO is committed to creating an environment of diversity and inclusion as a foundation for innovation.

    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," "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: the advancement of AVEO's pipeline, including the advancement of ficlatuzumab in multiple clinical studies; the potential efficacy, safety, and tolerability of ficlatuzumab, both as a stand-alone drug candidate and in combination with other therapies; the potential for outcomes from studies of ficlatuzumab to provide AVEO with opportunities to pursue regulatory strategies; the potential clinical utility of ficlatuzumab in areas of unmet need; the potential for tivozanib as a treatment option for patients with advanced HCC or relapsed/refractory or 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; 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 tivozanib in the United States; AVEO's expectations about its cash runway and its cash runway guidance; and AVEO's strategy, prospects, plans and objectives for its product candidates and for the Company 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: whether the results of TIVO-3 are sufficient to obtain marketing approval for tivozanib in the U.S., which turns on the ability of AVEO to demonstrate to the satisfaction of the FDA the safety and efficacy of tivozanib based upon the findings of TIVO-3, including its data with respect to PFS, the rate of adverse events, OS and other information that the FDA may determine for approval; 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, including, in particular, tivozanib and ficlatuzumab; 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 faces other risks relating to its business as well, including risks relating to the timing and costs of seeking and obtaining regulatory approval; AVEO's and its collaborators' ability to successfully enroll and complete clinical trials; 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, including its ability to successfully launch and commercialize tivozanib if it may be approved for commercialization by the FDA; 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; AVEO's ability to access up to $20.0 million of the Hercules loan facility, which turns on the achievement of milestones related to the approval and commercialization of tivozanib in the U.S., which milestones may not be achieved; adverse general economic 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.

    View Full Article Hide Full Article
  4. AVEO Oncology (NASDAQ:AVEO) today announced that Michael Bailey, president and chief executive officer of AVEO, will participate in two upcoming virtual investor conferences:

    Baird 2020 Global Healthcare Conference
    Date: Thursday, September 10
    Time: 8:30 AM Eastern Time

    H.C. Wainwright 22nd Annual Global Investment Conference
    Date: Monday, September 14
    Time: 4:30 PM Eastern Time

    A live webcast of the events can be accessed by visiting the investors section of the Company's website at www.aveooncology.com. A replay of the webcast will be archived for 30 days following the presentation date.

    About AVEO Pharmaceuticals, Inc.

    AVEO is developing an oncology pipeline designed to provide a better life for patients with cancer. AVEO's strategy…

    AVEO Oncology (NASDAQ:AVEO) today announced that Michael Bailey, president and chief executive officer of AVEO, will participate in two upcoming virtual investor conferences:

    Baird 2020 Global Healthcare Conference

    Date: Thursday, September 10

    Time: 8:30 AM Eastern Time

    H.C. Wainwright 22nd Annual Global Investment Conference

    Date: Monday, September 14

    Time: 4:30 PM Eastern Time

    A live webcast of the events can be accessed by visiting the investors section of the Company's website at www.aveooncology.com. A replay of the webcast will be archived for 30 days following the presentation date.

    About AVEO Pharmaceuticals, Inc.

    AVEO is developing an oncology pipeline designed to provide a better life for patients with cancer. 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, tivozanib (FOTIVDA®) is approved in the European Union and other countries by AVEO's partner EUSA for the treatment of adult patients with advanced renal cell carcinoma. AVEO is working to develop and commercialize tivozanib in North America as a treatment for renal cell carcinoma and hepatocellular carcinoma. AVEO has previously reported promising early clinical data on ficlatuzumab (anti-HGF mAb) in head and neck cancer, acute myeloid leukemia and pancreatic cancer and is conducting a randomized Phase 2 confirmatory clinical trial of ficlatuzumab in head and neck cancer. AVEO's earlier-stage pipeline includes several monoclonal antibodies in oncology development, including AV-203 (anti-ErbB3 mAb), AV-380 (anti-GDF15 mAb) and AV-353 (anti-Notch 3 mAb). AVEO is committed to creating an environment of diversity and inclusion as a foundation for innovation.

    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. Actual results or events could differ materially due to a number of important factors, including risks discussed in the section titled "Risk Factors" in AVEO's most recent Annual Report on Form 10-K, its quarterly reports on Form 10-Q and its other filings with the SEC. The forward-looking statements in this press release represent AVEO's views as of the date of this press release. AVEO anticipates that 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

    View Full Article Hide Full Article
  5. - NDA Filing Accepted by U.S. FDA for Tivozanib as a Treatment of Relapsed or Refractory Renal Cell Carcinoma; Assigned PDUFA Target Action Date of March 31, 2021 -

    - Preparations Underway to Support Potential Commercial Launch of Tivozanib in the U.S.; New Debt and Equity Financings, Partnership Milestones Potentially Provide for Working Capital into 2022 -

    - Company Evaluating Registrational Opportunities for Ficlatuzumab and Tivozanib Immunotherapy Combination Programs -

    - Company on Track for AV-380 IND Submission by Year-end; Phase 1 Clinical Study Planned for the First Quarter of 2021 -

    AVEO Oncology (NASDAQ:AVEO) today reported financial results for the second quarter ended June 30, 2020 and provided a business update.

    "The…

    - NDA Filing Accepted by U.S. FDA for Tivozanib as a Treatment of Relapsed or Refractory Renal Cell Carcinoma; Assigned PDUFA Target Action Date of March 31, 2021 -

    - Preparations Underway to Support Potential Commercial Launch of Tivozanib in the U.S.; New Debt and Equity Financings, Partnership Milestones Potentially Provide for Working Capital into 2022 -

    - Company Evaluating Registrational Opportunities for Ficlatuzumab and Tivozanib Immunotherapy Combination Programs -

    - Company on Track for AV-380 IND Submission by Year-end; Phase 1 Clinical Study Planned for the First Quarter of 2021 -

    AVEO Oncology (NASDAQ:AVEO) today reported financial results for the second quarter ended June 30, 2020 and provided a business update.

    "The first half of 2020 was one of the most important periods in AVEO's history to date, with the successful completion of the TIVO-3 study and the acceptance for filing and substantive review of a New Drug Application (NDA) for tivozanib as a treatment for relapsed or refractory renal cell carcinoma (RCC)," said Michael Bailey, president and chief executive officer of AVEO. "Through successful debt and equity financings, we now expect to have access to the capital to ensure a robust launch of FOTIVDA® (tivozanib) into 2022 to potentially address what we believe is a significant unmet need for an effective, better tolerated drug. Currently, more than half of patients are opting to forego third or later lines of therapy, largely due to issues of tolerability and a lack of evidence-based studies in this setting.1 Supported by positive results from TIVO-3, we believe tivozanib could address these challenges and allow patients to continue their fight against cancer, and therefore has the potential to become a standard of care in this large and growing segment of the market."

    Mr. Bailey added, "With TIVO-3 complete, we are now evaluating several opportunities to initiate new pivotal studies for both tivozanib and ficlatuzumab. Building on the TiNivo and DEDUCTIVE trials in RCC and hepatocellular carcinoma (HCC) respectively, we believe tivozanib's activity, favorable safety profile, and ability to significantly reduce regulatory T cells2 all have the potential to make tivozanib a companion tyrosine kinase inhibitor of choice in these settings. In addition, the early data we have seen in the randomized head and neck cancer (HNSCC) study with ficlatuzumab combined with cetuximab (ERBITUX®), which could serve as the basis for pursuing a pivotal study in this tumor type, has led us to initiate the process to evaluate securing additional clinical manufacturing capacity. Finally, we expect AV-380 to enter into a Phase 1 study in the first quarter of 2021, if an Investigational New Drug (IND) application which we expect to file by year end 2020, is accepted by the U.S. Food and Drug Administration (FDA)."

    Tivozanib Updates

    • Announced FDA Acceptance for Filing of an NDA for Tivozanib as a Treatment of Relapsed or Refractory RCC. In June 2020, AVEO announced that the FDA accepted for filing its NDA seeking approval for tivozanib, the Company's next-generation vascular endothelial growth factor receptor tyrosine kinase inhibitor (VEGFR-TKI), as a treatment for relapsed or refractory RCC. The FDA has assigned the application standard review and a Prescription Drug User Fee Act target action date of March 31, 2021. The FDA also indicated that they do not currently plan on convening an Oncologic Drug Advisory Committee (ODAC) to discuss the application.



      The NDA submission is based on AVEO's pivotal Phase 3 study, TIVO-3, comparing tivozanib to sorafenib in 3rd and 4th line RCC. The application is also supported by three additional trials in RCC and includes safety data from over 1,000 clinical trial subjects.
    • Preparations Underway to Support Potential Commercial Launch of Tivozanib in the U.S. In preparation for the potential commercial launch of tivozanib in the U.S., the Company is actively engaged in the expansion of its sales, marketing, market access and medical affairs teams, as well as working to enable distribution capabilities by the end of the year. The Company also today announced that the FDA has conditionally accepted "FOTIVDA®" as the proprietary brand name for tivozanib in the U.S.
    • Presented TIVO-3 Final Overall Survival Results at ASCO 2020 Virtual Scientific Program. In May 2020, the Company presented data from the final overall survival (OS) analysis of the pivotal Phase 3 TIVO-3 trial at the American Society of Clinical Oncology (ASCO) 2020 Virtual Scientific Program. The final OS hazard ratio (HR) of 0.97 was similar to those observed with prior approved VEGFR TKI vs. VEGFR TKI pivotal studies in RCC.3-6 TIVO-3 represents the first positive Phase 3 superiority study designed to help guide treatment decisions in third and fourth line RCC, a growing patient population with a high unmet medical need for effective and better tolerated therapies.



      A copy of the presentation is available on the Publications & Presentations section of AVEO's website.
    • Announced Advancement to the Phase 2 Portion of Phase 1b/2 DEDUCTIVE Study of Tivozanib in Combination with IMFINZI® (durvalumab) in Previously Untreated HCC After No Dose-Limiting Toxicities Observed in Phase 1 Portion. In May 2020, AVEO announced that the Phase 1b/2 DEDUCTIVE clinical trial evaluating tivozanib in combination with IMFINZI® (durvalumab), AstraZeneca's human monoclonal antibody directed against programmed death-ligand 1 (PD-L1), in patients with first line metastatic HCC has progressed to the Phase 2 portion of the trial. Advancement of the study into the Phase 2 portion, for which enrollment is currently underway, was based on findings from the recently completed Phase 1 portion of the combination in which no dose limiting toxicities were observed.



      Taken together with positive results from the TiNivo study, a Phase 1b/2 multicenter trial of tivozanib in combination with PD-1 inhibitor nivolumab (OPDIVO®, Bristol-Myers Squibb) in first or second line metastatic RCC, AVEO is currently evaluating opportunities to initiate potential registrational immunotherapy combination studies.

    Tivozanib Non-Oncology Partnership Update

    • $2.8 Million Development Milestone from Kyowa Kirin Co., Ltd. The Company recently announced that it earned a $2.8 million development milestone payment from partner Kyowa Kirin Co., Ltd. (Kyowa Kirin). The milestone relates to acceptance by the Japanese Pharmaceuticals and Medical Devices Agency of an IND application for tivozanib in a non-oncology indication being developed by Kyowa Kirin.



      Under the terms of AVEO's agreement with Kyowa Kirin, in addition to the previously-paid upfront payment of $25 million to AVEO, waiver of AVEO's obligation to make an $18 million milestone payment upon AVEO gaining U.S. marketing approval of tivozanib for RCC, and the $2.8 million IND development milestone, Kyowa Kirin has also agreed to pay AVEO up to an additional $388 million in potential milestone payments upon the successful achievement of certain development, regulatory, and commercial objectives in non-oncology indications of tivozanib. Kyowa Kirin will also be obligated to make tiered royalty payments on the net sales of a product for these indications, ranging from a high single-digit to low double-digit percent.

    Ficlatuzumab Update

    • Based on Early Data from Randomized Phase 2 Study of Ficlatuzumab in Combination with Erbitux in Head and Neck Cancer, AVEO Currently Evaluating Phase 3 Study Opportunities. AVEO's potent hepatocyte growth factor (HGF) inhibitory antibody, ficlatuzumab, which binds to the HGF ligand with high affinity and specificity to inhibit HGF/c-Met biological activities, is being studied in an ongoing randomized confirmatory Phase 2 study in combination with cetuximab, an EGFR-targeted antibody, in metastatic HNSCC. The study was designed to confirm findings from a Phase 1 study of ficlatuzumab and cetuximab where the combination was well tolerated and resulted in a disease control rate of 67%, as well as prolonged progression free and OS compared to historical controls. The Phase 2 multi-center study is being conducted under the direction of Julie E. Bauman, MD, MPH, Professor of Medicine, Chief, Division of Hematology/Oncology, Associate Director of Translational Research, University of Arizona Cancer Center. Enrollment is expected to conclude in the fourth quarter of 2020, and results from the study are expected to be presented at a scientific meeting in the first half of 2021. AVEO and its partner Biodesix are evaluating the process to secure additional clinical manufacturing of ficlatuzumab to potentially enable a Phase 3 clinical trial of ficlatuzumab for the treatment of HNSCC in 2022.
    • Data from Phase 1 Study of Ficlatuzumab and Cetuximab in HNSCC Published in Cancers. Data from the Phase 1 study of ficlatuzumab and cetuximab in patients with HNSCC were recently published in the journal Cancers. The combination of ficlatuzumab and cetuximab demonstrated an acceptable safety profile and showed promising antitumor activity in a refractory HNSCC patient population. A link to the publication, titled, "Phase I Study of Ficlatuzumab and Cetuximab in Cetuximab-Resistant, Recurrent/Metastatic Head and Neck Cancer", is available on the Publications & Presentations section of AVEO's website.

    AV-380 Update

    • Company on Track for IND Application Submission by Year-end, with Phase 1 Clinical Study Planned for the First Quarter of 2021. AVEO plans to submit an IND application to the FDA for AV-380, its first-in-class, potent, humanized inhibitory antibody targeting growth differentiation factor 15 (GDF15), for the treatment of cancer cachexia by year-end. Cachexia, a common complication in patients with advanced cancer and other chronic diseases, is a complex metabolic syndrome characterized by malnutrition and severe involuntary weight loss due to the loss of muscle and fat tissue, as well as the clinical manifestation of anemia, inflammation and suppression of immune functions. Preparations for a Phase 1 trial are currently underway.

    Corporate Updates

    • Raised Gross Proceeds of $51.1M in Oversubscribed Public Offering. In June 2020, AVEO announced the closing of an oversubscribed underwritten public offering yielding aggregate gross proceeds of approximately $51.1 million, before deducting underwriting discounts and commissions and offering expenses payable by AVEO. The financing was led by investors Deerfield Management, New Enterprise Associates and Cormorant Capital.
    • Announced Restructuring of Existing Term Loan with Closing of New Tranched, $35 Million Debt Facility, Potentially Providing for Working Capital into 2022. The Company announced today the closing of a tranched, $35 million debt facility with Hercules Capital, Inc. and its affiliates. The new facility has a maturity of 36 months, extendable up to 48-months, and an interest-only period of 12 months, extendable up to 30 months upon the achievement of performance milestones related to the approval and commercialization of tivozanib. Under the terms of the agreement, the initial tranche of $15 million fully refinanced AVEO's existing Hercules term loan facility, which had an outstanding principal amount of approximately $9.7 million, providing net new proceeds of $5.3 million. A second $10 million tranche is contingent upon the approval of the tivozanib NDA by the FDA as a treatment for RCC, and certain other terms and conditions. An additional two $5 million tranches will become available after that time – one if net product revenues of tivozanib reach $20.0 million within a specified time frame, and the other at the lender's consent. As previously announced, the FDA has assigned AVEO's NDA a Prescription Drug User Fee Act target action date of March 31, 2021.

    Second Quarter 2020 Financial Results

    • AVEO ended Q2 2020 with $71.4 million in cash, cash equivalents and marketable securities as compared with $47.7 million at December 31, 2019.
    • Total revenue was approximately $0.7 million in each of Q2 2020 and Q2 2019.
    • Research and development expense for Q2 2020 was $4.4 million compared with $2.6 million for Q2 2019.
    • General and administrative expense for Q2 2020 was $3.7 million compared with $3.0 million for Q2 2019.
    • Net loss for Q2 2020 was $7.3 million, or net loss of $0.42 per basic and diluted share, compared with net loss of $3.1 million for Q2 2019, or net loss of $0.20 per basic and diluted share, respectively. The net loss in Q2 2019 reflects a $2.2 million non-cash gain that was attributable to the decrease in fair value of the 2016 private placement warrant liability that principally resulted from a decrease in the stock price that occurred within the period.

    Financial Guidance

    AVEO believes that its as-adjusted $79.5 million in cash, cash equivalents and marketable securities as of June 30, 2020, consisting of $71.4 million in cash, cash equivalents and marketable securities at June 30, 2020 together with the $2.8 million KKC milestone and the $5.3 million in new loan funding from Hercules, along with partnership cost sharing reimbursements, royalties from EUSA's FOTIVDA sales and, if the pending marketing application for FOTIVDA is approved by the FDA, resulting product revenues upon commercial launch and the potential additional $20 million in credit under the Hercules loan, would allow the Company to fund planned operations into 2022.

    In accordance with Accounting Standards Update No. 2014-15, Disclosure of Uncertainties about an Entity's Ability to Continue as a Going Concern (Accounting Standards Codification Subtopic 205-40), cash flows that are contingent on FDA approval, such as product revenues, cannot be reflected in the going concern assessment. As a result, Hercules loan funding contingent on such approval and revenue is also excluded from our going concern assessment. Accordingly, the Company continues to have a going concern opinion.

    About Tivozanib (FOTIVDA®)

    Tivozanib (FOTIVDA®) is an oral, once-daily, next-generation vascular endothelial growth factor receptor (VEGFR) tyrosine kinase inhibitor (TKI) discovered by Kyowa Kirin and approved for the treatment of adult patients with advanced renal cell carcinoma (RCC) in the European Union and other countries in the EUSA territory. It is a potent, selective and long half-life inhibitor of all three VEGF receptors and is designed to optimize VEGF blockade while minimizing off-target toxicities, potentially resulting in improved efficacy and minimal dose modifications.8,9 Tivozanib is being studied in the TIVO-3 trial, which is supporting a regulatory submission of tivozanib in the U.S. seeking marketing approval as a treatment for relapsed or refractory RCC. Tivozanib has been shown to significantly reduce regulatory T-cell production in preclinical models2 and has demonstrated synergy in combination with nivolumab (anti PD-1) in a Phase 2 study in RCC.10 Tivozanib has been investigated in several tumor types, including renal cell, hepatocellular, colorectal, ovarian and breast cancers. Tivozanib is also being studied by partner Kyowa Kirin in non-oncology indications.

    About AVEO Pharmaceuticals, Inc.

    AVEO is developing an oncology pipeline designed to provide a better life for patients with cancer. 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, tivozanib (FOTIVDA®) is approved in the European Union and other countries by AVEO's partner EUSA for the treatment of adult patients with advanced renal cell carcinoma. AVEO is working to develop and commercialize tivozanib in North America as a treatment for renal cell carcinoma and hepatocellular carcinoma. AVEO has previously reported promising early clinical data on ficlatuzumab (anti-HGF mAb) in head and neck cancer, acute myeloid leukemia and pancreatic cancer and is conducting a randomized Phase 2 confirmatory clinical trial of ficlatuzumab in head and neck cancer. AVEO's earlier-stage pipeline includes several monoclonal antibodies in oncology development, including AV-203 (anti-ErbB3 mAb), AV-380 (anti-GDF15 mAb) and AV-353 (anti-Notch 3 mAb). AVEO is committed to creating an environment of diversity and inclusion as a foundation for innovation.

    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," "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: the potential for tivozanib as a treatment option for patients with advanced HCC or relapsed/refractory or advanced RCC, following earlier TKI and immunotherapy treatment; the potential efficacy, safety, and tolerability of tivozanib, both as a stand-alone drug candidate and in combination with other therapies in several indications; 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 tivozanib in the United States; the period in which AVEO expects to have cash to fund its operations and the contingencies upon which such guidance is dependent ;and AVEO's strategy, prospects, plans and objectives for its product candidates and for the Company 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: whether the results of TIVO-3 are sufficient to obtain marketing approval for tivozanib in the U.S., which turns on the ability of AVEO to demonstrate to the satisfaction of the FDA the safety and efficacy of tivozanib based upon the findings of tivozanib's clinical trials, including its data with respect to PFS, the rate of adverse events, OS and other information that the FDA may determine for approval; 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 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 faces other risks relating to its business as well, including risks relating to the timing and costs of seeking and obtaining regulatory approval; AVEO's and its collaborators' ability to successfully enroll and complete clinical trials; 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, including its ability to successfully launch and commercialize tivozanib if it may be approved for commercialization by the FDA; 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; AVEO's ability to access up to $20.0 million of the Hercules loan facility, which turns on the achievement of milestones related to the approval and commercialization of tivozanib in the U.S., which milestones may not be achieved; adverse general economic 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. Decision Resources, 2019
    2. Pawlowski N et al. AACR 2013. Poster 3971
    3. Hutson et al. Clinical Genitourinary Cancer; Vol. 15, No. 1, 72-6.
    4. Choueiri et al. European Journal of Cancer 2018; 94: 115e125
    5. Motzer et. al. Lancet Oncol 2013; 14: 552–62.
    6. Motzer, et al. N Engl J Med. 2014;370(18):1769-1770.
    7. ZS Assoc. 2017 Sales Revenue
    8. Fotivda (Tivozanib) SmPC August 2017
    9. Motzer RJ, Nosov D, Eisen T, et al. J Clin Oncol 2013; 31(30): 3791-9
    10. Barthelemy et al. ESMO 2018. Poster 878P

    AVEO PHARMACEUTICALS, INC.

    Condensed Consolidated Statements of Operations

    (In thousands, except per share amounts)

    (Unaudited)

     

     

     

    Three Months Ended

    June 30,

     

     

    Six Months Ended

    June 30,

     

     

     

    2020

     

     

    2019

     

     

    2020

     

     

    2019

     

    Revenues:

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

    Collaboration and licensing revenue

     

    $

    494

     

     

    $

    493

     

     

    $

    987

     

     

    $

    1,947

     

    Partnership royalties

     

     

    255

     

     

     

    210

     

     

     

    546

     

     

     

    367

     

     

     

     

    749

     

     

     

    703

     

     

     

    1,533

     

     

     

    2,314

     

    Operating expenses:

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

    Research and development

     

     

    4,419

     

     

     

    2,611

     

     

     

    12,245

     

     

     

    9,463

     

    General and administrative

     

     

    3,737

     

     

     

    2,986

     

     

     

    7,409

     

     

     

    5,441

     

     

     

     

    8,156

     

     

     

    5,597

     

     

     

    19,654

     

     

     

    14,904

     

    Loss from operations

     

     

    (7,407

    )

     

     

    (4,894

    )

     

     

    (18,121

    )

     

     

    (12,590

    )

    Other income (expense), net:

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

    Interest expense, net

     

     

    (349

    )

     

     

    (451

    )

     

     

    (664

    )

     

     

    (1,015

    )

    Change in fair value of PIPE Warrant liability

     

     

    450

     

     

     

    2,210

     

     

     

    3,098

     

     

     

    11,025

     

    Other income (expense), net

     

     

    101

     

     

     

    1,759

     

     

     

    2,434

     

     

     

    10,010

     

    Net loss

     

    $

    (7,306

    )

     

    $

    (3,135

    )

     

    $

    (15,687

    )

     

    $

    (2,580

    )

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

    Net loss per share - basic and diluted

     

    $

    (0.42

    )

     

    $

    (0.20

    )

     

    $

    (0.94

    )

     

    $

    (0.18

    )

    Weighted average number of common shares outstanding

     

     

    17,364

     

     

     

    15,902

     

     

     

    16,722

     

     

     

    14,574

     

    Consolidated Balance Sheet Data

    (In thousands)

    (Unaudited)

     

     

     

    June 30,

    2020

     

     

    December 31,

    2019

     

    Assets

     

     

     

     

     

     

     

     

    Cash, cash equivalents and marketable securities

     

    $

    71,449

     

     

    $

    47,745

     

    Accounts receivable

     

     

    1,208

     

     

     

    1,631

     

    Prepaid expenses and other current assets

     

     

    1,571

     

     

     

    1,224

     

    Property and equipment, net

     

     

    96

     

     

     

     

    Operating lease right-of-use asset

     

     

    1,120

     

     

     

     

    Other assets

     

     

    158

     

     

     

     

    Total assets

     

    $

    75,602

     

     

    $

    50,600

     

     

     

     

     

     

     

     

     

     

    Liabilities and stockholders' equity

     

     

     

     

     

     

     

     

    Accounts payable and accrued expenses

     

    $

    8,906

     

     

    $

    9,482

     

    Loans payable, net of discount

     

     

    11,133

     

     

     

    15,766

     

    Deferred revenue and research and development reimbursements

     

     

    3,798

     

     

     

    4,619

     

    PIPE Warrant liability

     

     

    1,999

     

     

     

    5,097

     

    Operating lease liability

     

     

    924

     

     

     

     

    Other liabilities

     

     

    790

     

     

     

    790

     

    Stockholder's equity

     

     

    48,052

     

     

     

    14,846

     

    Total liabilities and stockholders' equity

     

    $

    75,602

     

     

    $

    50,600

     

     

    View Full Article Hide Full Article
View All AVEO Pharmaceuticals Inc. News