AVEO Oncology announces restructuring of an existing $ 35 million loan
BOSTON–(BUSINESS WIRE) – AVEO Oncology (Nasdaq: AVEO) today announced that it has entered into a $ 35 million tranche credit facility with Hercules Capital, Inc. (NYSE: HTGC) and its affiliates. The new facility has a term of 36 months, which can be extended up to 48 months, and a pure interest period of 12 months, which can be extended to up to 30 months if the performance milestones in connection with the approval and marketing of Tivozanib can be achieved.
Under the terms of the agreement, the first tranche of $ 15 million fully refinanced AVEO’s existing Hercules loan facility with an outstanding principal amount of approximately $ 9.7 million and delivered new net proceeds of $ 5.3 million. A second tranche of $ 10 million is pending approval of the Tivozanib New Drug Application (NDA) by the US Food and Drug Administration (FDA) for the treatment of renal cell carcinoma (RCC) and certain other conditions. Thereafter, another two tranches of $ 5 million will be available – one if product revenue from net sales of tivozanib reaches $ 20.0 million within a certain timeframe, and the other with the approval of the lender. As previously announced, the FDA has assigned AVEO’s NDA a target for the March 31, 2021 action date for the Prescription Drug Fee Act.
“The refinancing of our credit facility with Hercules Capital is expected to give us access to capital that will fund our planned operations well into the anticipated introduction of tivozanib, ”said Michael Bailey, President and Chief Executive Officer of AVEO. “We will continue to work closely with the FDA to review our NDA as we grow our trading organization, investigate potentially critical combination immunotherapy studies for tivozanib, and advance our pipeline. ”
“We look forward to expanding and expanding our funding partnership with AVEO in preparation for the possible approval and launch of tivozanib. Our relationship with AVEO has spanned nearly 15 years and this recent funding is yet another example of our ability to support innovative life science companies through all stages of development and through multiple value turning points, “said Bryan Jadot, Senior Managing Director and Life Sciences Group Head for Hercules.
About AVEO Pharmaceuticals, Inc.
AVEO is developing an oncology pipeline to help cancer patients lead a better life. AVEO’s strategy is to focus its resources on developing and commercializing its product candidates in North America while leveraging partnerships to support development and commercialization in other regions. 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 developing and commercializing tivozanib in North America for the treatment of renal cell carcinoma and hepatocellular carcinoma. AVEO has already 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 confirmatory phase 2 clinical trial of ficlatuzumab in head and neck cancer. AVEO’s previous 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 the basis for innovation.
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements from AVEO within the meaning of the Private Securities Litigation Reform Act of 1995 that involve significant risks and uncertainties. All statements in this press release, other than historical facts, are forward-looking statements. The words “anticipate”, “believe”, “expect”, “hope”, “intend”, “can”, “plan”, “potentially”, “could”, “should”, “would”, “seek”, “Looking ahead,” “looking ahead,” “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 those identifying words. These forward-looking statements include, among other things, statements about: the potential of tivozanib as a treatment option for patients with advanced HCC or relapsed / refractory or advanced RCC and after previous TKI and immunotherapy treatment; the potential efficacy, safety and tolerability of tivozanib both as a standalone drug candidate and in combination with other therapies in multiple indications; the implementation of AVEO’s 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 the commercialization of tivozanib in the United States; the period in which AVEO expects to have cash to finance its business activities and the contingencies on which these guidelines depend; and AVEO’s strategy, outlook, plans and goals for its product candidates and for the company in general. AVEO has based its expectations and estimates on assumptions that could prove to be incorrect. For this reason, readers are cautioned not to rely on these expectations and estimates. Actual results or events could differ materially from the plans, intentions and expectations disclosed in AVEO’s forward-looking statements due to a number of important factors, including risks relating to: Whether TIVO-3 results are sufficient to warrant marketing approval For tivozanib in the US, based on AVEO’s ability to determine the safety and efficacy of tivozanib to the satisfaction of the FDA, based on the results of tivozanib clinical trials including its data on PFS, adverse event rate, operating system and other information that the FDA deems relevant to approval; AVEO’s ability and the ability of its licensees to demonstrate the safety, efficacy, and clinically meaningful benefit of AVEO’s product candidates to the satisfaction of appropriate regulatory agencies such as the FDA; and AVEO’s ability to enter into and maintain cooperation and licensing agreements with third parties, as well as its ability and the ability of its strategic partners to achieve development and commercialization goals under those agreements. AVEO is also exposed to other risks related to its business, including risks related to the timing and cost of applying for and obtaining regulatory approval; the ability of AVEO and its employees to successfully enroll and complete clinical trials; AVEO’s ability to comply with regulatory requirements applicable to its product candidates; AVEO’s ability to obtain and maintain adequate intellectual property protection in relation to its product candidates; AVEO’s ability to successfully execute on its strategic plans, including its ability to successfully market and commercialize tivozanib if it is cleared for marketing by the FDA; AVEO’s ability to raise the significant additional funding needed to achieve its goals, including those related to the development and commercialization of tivozanib; unplanned capital requirements; AVEO’s ability to access up to $ 20.0 million of the Hercules Credit Facility, which requires the achievement of milestones related to the US approval and commercialization of tivozanib that may not be reached; AVEO’s ability to meet various financial and operational obligations contained in its credit facilities; unfavorable general economic and industry conditions; the potential negative impact of the COVID-19 pandemic on business continuity, financial condition, operating results, liquidity and AVEO’s ability to successfully and timely register, complete and read data from its clinical trials; Competitive factors; and the risks outlined in the “Risk Factors” and “Management Discussion and Analysis of Financial Condition and Results of Operations – Liquidity and Capital Resources, ”included in AVEO’s quarterly and annual reports filed with the Securities and Exchange Commission (SEC) and AVEO’s other filings with the SEC. The forward-looking statements in this press release reflect the views of AVEO as of the date of this press release, and subsequent events and developments could cause their views to change. Although AVEO may update these forward-looking statements at a certain point in the future, AVEO expressly disclaims any obligation to do so. You should not, therefore, assume that these forward-looking statements represent AVEO’s views on any date other than the date of this press release.
Any reference to the AVEO website address in this press release is intended to be an inactive text reference only and not an active hyperlink.