CymaBay in $100-million non-dilutive financing for Phase 3 trial

CymaBay Therapeutics

CymaBay Therapeutics (NASDAQ:CBAY) announced a $100-million non-dilutive financing transaction with Abingworth to fund the Phase 3 development program for seladelpar in primary biliary cholangitis (PBC), including the Phase 3 RESPONSE clinical trial.

“By thoughtfully risk-sharing development costs with Abingworth, who shares our belief in the potential of seladelpar to serve as an improved second-line treatment for patients with PBC, we have secured the additional funding needed for the Phase 3 program,” Sujal Shah, CEO of CymaBay, said in a statement.

“This transaction provides us with capital needed to complete Phase 3 development and an investor with a long track record of successfully funding innovative companies focused on life sciences,” he added.

Under the accord, CymaBay will receive up to $100-million of seladelpar development costs, of which $75-million will be received in three installments over approximately six months. CymaBay has an option to receive a further $25-million within approximately two months of the completion of enrollment of CymaBay’s Phase 3 RESPONSE clinical trial.

In exchange, CymaBay will make fixed payments spread over a six-year period based on regulatory approval in the U.S. or the EU after the first regulatory approval is obtained, as well as pay fixed and capped sales milestones based on U.S. product sales.

CymaBay has the ability to accelerate payment at a reduced amount on regulatory approval and in the event of a change of control of CymaBay. CymaBay retains upside potential for seladelpar in the U.S. along with full worldwide commercial rights.

CymaBay is currently dosing patients in its Phase 3 RESPONSE clinical trial as well as its ASSURE open-label extension trial and other Phase 1 NDA-enabling clinical studies.