CymaBay reports Q2 EPS (1c), consensus (20c)

Reports Q2 revenue $31.02M, consensus $9.9M. Collaboration revenue recognized for the three and six months ended June 30 was $31M, on completion of the initial technology transfer associated with the license to develop and commercialize seladelpar in Japan. Of the $34.2M upfront payment received from Kaken, $2.7M remains deferred and will be recognized upon completion of the company’s ongoing clinical data delivery and CMC development performance obligations. Sujal Shah, president and CEO of CymaBay, stated, “I’m incredibly proud of the progress our teams have made thus far this year as we march towards our key and exciting milestone in the third quarter when we expect to report top-line results from RESPONSE, our global phase 3 registration study of seladelpar in patients with primary biliary cholangitis (PBC). With RESPONSE nearing completion and ASSURE having enrolled over 300 patients to date, we believe the seladelpar development program in PBC is one of the most robust development programs in PBC ever conducted. We continue to believe seladelpar has the potential to be a differentiated second-line treatment option offering patients benefits on markers of disease associated with risk of progression and on symptoms. As announced earlier today, we are now also actively recruiting patients in IDEAL, a study to evaluate seladelpar’s effects on biochemical normalization in PBC patients who only achieve a partial response to first-line treatment. We believe data from IDEAL has the potential to reset expectations for second-line treatment in PBC. In anticipation of a successful data readout in RESPONSE and regulatory acceptance, our organizational build efforts are also underway as we start to put together key components of our commercial and medical affairs infrastructure.”