CymaBay Therapeutics Inc. (NASDAQ:CBAY) gained 5% in the last trading session to close at $13.22 after the company announced its Q4 and FY2018 results as well as providing a corporate update.
Milestones and financial highlights
The company had a busy year, and in the Q42018 it achieved a major milestone by initiating the ENHANCE phase 3 seladelpar study in PBC. The CEO and President Sujal Shah indicated that the company had made good progress and that the ENHANCE study was initiated because of the second phase that had a compelling and differentiated profile that demonstrated the potential of seladelpar in the treatment of PBC patients. The drug showed progress regarding its efficacy and tolerability compared to current second-line treatment. The FDA has granted seladelpar Breakthrough Therapy designation for PBC. It has also received PRIority MEdicine status from the EMA.
In Q42018 the company also reported positive data from the second phase study which they presented during the 2018 Liver Meeting. The results demonstrated the potential of seladelpar as a safe second-line treatment alternative
At the beginning of the year, the company had $178,7 million in cash and cash equivalents as well as marketable securities. The available cash is sufficient to fund the operating expenses and programs through to 2021. R&D expenses increased in Q42018 and FY2018 which was primarily a result of the increase in clinical trials of seladelpar in the expansion and extension of the second phase clinical study, as well as start-up activities in the third phase, ENHANCE study. Equally the enrolment in the NASH second phase clinical study and NDA enabling studies contributed to the increase in R&D expenses.
The CEO indicated that going to 2019 the company will continue making progress in the evaluation of opportunities beyond NASH and PBC that can help the company expand seladelpar development for other severe inflammatory liver diseases that have high unmet needs. The work will involve thought leaders, assessment of unmet needs, and evaluation of the clinical and scientific rationale of development as well as other significant criteria that can enable the company to shape its future. More updates are expected within the year.