20 January 2021 - - US-based Aveo Oncology (NASDAQ: AVEO) has received a commitment letter for an incremental USD 10m loan from Hercules Capital, Inc. (NYSE: HTGC) and its affiliates, to be added to the current tranched, USD 35m debt facility secured with Hercules in August 2020 through an amendment to the amended and resaid loan and security agreement, the company said.

Terms of the facility would remain otherwise unchanged from the loan agreement, with the loan bearing 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 loan agreement, an initial tranche of USD 15m was drawn down at signing.

Under the terms of the commitment letter, a second tranche of USD 20m would be available contingent upon the approval of the tivozanib New Drug Application by the US Food and Drug Administration as a treatment for relapsed or refractory renal cell carcinoma.

An additional USD 10m will become available if certain sales criteria are met.

As previously announced, the FDA has assigned Aveo's NDA a Prescription Drug User Fee Act target action date of March 31, 2021.

The nonbinding commitment letter is subject to Aveo and Hercules entering into a definitive amendment of the Loan Agreement setting forth the terms of the additional borrowing.

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 territory of the Aveo's partner, EUSA Pharma Ltd. for the treatment of adult patients with advanced RCC.

Tivozanib is being studied in the TIVO-3 trial, which is supporting a regulatory submission of tivozanib in the US seeking marketing approval as a treatment for relapsed or refractory RCC.

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.