Calithera Biosciences, Inc.

Good day, and thank you for standing by. Welcome to the Calicera Biosciences 2 Q21 earnings conference call. At this time, all participants are in listen-only mode. After the speaker's presentation, there will be a question and answer session. And to ask a question during that time, you will need to press star 1 on your telephone keypad. If you require further assistance, please press star 0. I would like to hand the conference over to your speaker for today, Stephanie Wong. Please go ahead.

Thank you, operator. Good afternoon, everyone. Welcome to our second quarter 2021 conference call. Joining me today are Susan Molyneux, founder, president, and CEO, and Keith Orford, chief medical officer. Earlier this afternoon, we issued a press release which included an overview of our second quarter 2021 financial and operational results, which can be accessed through our website at calathera.com. Before we begin, I would like to remind you that today's discussion will include statements about our future expectations, plans, and prospects, that constitute forward-looking statements for purposes of the safe harbor provisions under the Private Securities Legation Reform Act of 1995. Actual results may differ materially from those indicated by these forward-looking statements as a result of various important factors, including those discussed in the risk factor section of our periodic filings with the SEC. In addition, any forward-looking statements represent our views only as of today and should not be relied upon as representing our views as of any subsequent date While we may elect to update these forward-looking statements at some point in the future, we specifically disclaim any obligation to do so, even if our views change. Please note that this call is being recorded. And with that, I'll turn the call over to Susan.

Thanks, Stephanie. Good afternoon, everyone, and thank you for joining us today on our second quarter 2021 conference call. In the second quarter, we continued to execute against our key strategic and operational objectives, which are focused on the advancement of our two lead programs, teloglenostat in non-small cell lung cancer and our oral arginase inhibitor, CB280, for the treatment of cystic fibrosis. The KEEP-SAFE trial, evaluating teloglenostat in combination with standard of care chemoimmunotherapy for first-line non-small cell lung cancer patients with KEEP1 or Nrf2 genetic mutations, continues to enroll, and we remain on track to report interim data in the fourth quarter of 2021. CB280 continues to enroll patients in our Phase 1B dose escalation study for the treatment of cystic fibrosis. As a reminder, we are conducting this study with support from the Cystic Fibrosis Foundation, including an award of up to $2.4 million for the clinical development of CB280. Looking beyond our two core programs, we signed a worldwide license agreement with Antigen for the development and commercialization of CB708, our internally discovered small molecule CB73 inhibitor. In preclinical data presented at AECR and CITSE in 2019, we demonstrated that CB708 has immune-mediated single-agent activity in syngeneic mouse models. and that it showed enhanced anti-tumor activity when combined with either an anti-PD-L1 or with chemotherapy. In exchange for the exclusive worldwide rights to develop CD708, we received from Antigen an upfront payment and are eligible to receive additional development, regulatory, and sales milestones, as well as tiered royalties on sales up to low double-budgets. We view the agreement with Antigen as an important validation of our proprietary drug discovery engine, as it demonstrates our ability to discover novel, highly promising therapeutic compounds. In addition, in June, we joined the Broad Institute's Cancer Dependency Map, or DEPMAP, consortium, an initiative whose goal is to discover new targets and biomarkers for precision cancer therapeutics. And we look forward to collaborating with them to drive precision medicine forward. We remain committed to delivering on our mission to bring to market novel therapeutics that address major unmet medical needs. We believe that the steps we've taken in the first half of 2021 position us well. We expect several important milestones to be achieved in the second half of the year and look forward to providing additional details as they are reached. And with that, I will pass the call over to Keith for additional details on our clinical program.