Thursday May 2, 2019 0 comments
BOULDER -- Clovis Oncology, Inc. (NASDAQ: CLVS) today announced it has entered into an agreement for up to $175 million in non-dilutive clinical trial financing with certain affiliates of TPG Sixth Street Partners to reimburse Clovis’ costs and expenses related to the ATHENA clinical trial.
ATHENA is Clovis Oncology’s largest clinical trial, with a planned target enrollment of 1000 patients across more than 270 sites in at least 25 countries.
The Clovis-sponsored Phase 3 ATHENA study in advanced ovarian cancer is the first-line maintenance treatment setting evaluating rucaparib (Rubraca) plus nivolumab (PD-1 inhibitor), rucaparib, nivolumab and placebo in newly-diagnosed patients who have completed platinum-based chemotherapy.
This study initiated in Q2 2018 and is currently enrolling patients.
“The ATHENA study is a very important trial for us as we seek to continue to expand the available therapeutic options for women with ovarian cancer,” said Patrick J. Mahaffy, Clovis president and CEO.
“ATHENA is also our largest study, with a planned target enrollment of approximately 1,000 patients, which is expected to have a meaningful impact on our cash flow over the next few years.
“We are pleased to work with TPG Sixth Street Partners, which has provided us with a financing option that we believe uniquely meets our need to balance future investment in Rubraca with our anticipated cash flow needs.”
Under the terms of the agreement, financing for ATHENA clinical trial expenses will be paid quarterly, in arrears, beginning Q2 2019 generally through 1H 2022 after a potential first-line ovarian cancer maintenance approval for Rubraca.
Clovis would begin to repay the loan beginning with the approval by the FDA of an expansion of the Rubraca label indication resulting from the ATHENA trial or in 1H 2022, or sooner in the event the trial is terminated, or the company determines that the results of the ATHENA Trial are insufficient to achieve such an expansion of the Rubraca label to cover an indication based on the ATHENA trial.
Payments are based on a certain percentage of the revenues generated from the sales, and any future out-licensing, of Rubraca with quarterly payment caps depending on trial outcome.
The potential maximum amount that could be required to be repaid under the agreement is two times the aggregate borrowed amount. For a more detailed description of the terms of the financing, see Clovis’ Current Report on 8-K filed with the SEC.