Calithera Biosciences, Inc.

And welcome to the Caldera Biosciences Fourth Quarter 2020 Earnings Conference Call. At this time, all participants are in a listen-only mode. After the speaker presentation, there will be a question and answer session. To ask a question during the session, you will need to press star 1 on your telephone. If you require any further assistance, please press star 0. I would now like to hand the conference to your speaker today, Jennifer McNeely, VP Investor Relations. Please go ahead, ma'am.

Thank you, Joelle. Good afternoon, everyone. Welcome to our year-end 2020 conference call. Joining me today are Susan Molyneux, our founder, president, and CEO, Keith Orford, chief medical officer, and Stephanie Wong, chief financial officer. We have issued our press release, and it 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 provision under the Private Securities Litigation Reform Act of 1995. Actual results may differ material from those indicated by these forward-looking statements as a result of various important factors including those in the risk factors discussed in the risk factors section of our quarterly report on Form 10Q, followed by 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 this call is being recorded, and with that, I'll turn the call over to Susan.

Thank you, Jennifer. Good afternoon, everyone, and thank you for joining us today on our fourth quarter and year-end 2020 conference call. On behalf of the entire team, I'd like to say we hope that you and your friends and families remain healthy. 2020 was a challenging year for nearly everybody as we faced new challenges in public health. Despite the challenges we faced, we are quite hopeful for the future. At Califera, 2020 was a year of execution. We successfully completed and reported results of our global randomized trial in renal cell carcinoma early in 2021 while advancing our pipeline of novel therapeutics. We want to thank all of our employees who have done an extraordinary job of maintaining a high level of professionalism, productivity, and dedication at work, particularly towards helping us achieve our goal of reporting top-line results of the Kantata trial in January. We're both appreciative and proud of our entire team for accomplishing a number of challenging goals. And while we are disappointed in the results of the Kantata trial, we remain enthusiastic for the potential of glutaminase inhibition to be a novel approach to the treatment of cancer. And we remain committed to our mission of being an integrated biotechnology company that develops novel small molecule on co-metabolism drugs, drugs that are targeting tumor and immune cell metabolism pathways for the treatment of cancer and other diseases. By building a pipeline of novel therapeutic product candidates, we are creating multiple opportunities to positively impact clinical outcomes for patients and drive development programs towards commercialization. We are continuing to develop teleglanostat, and we are enrolling the randomized keepsake trial in first-line non-small-cell lung cancer patients harboring genetic mutations in KEEP or Nrf2. We also continue to evaluate teleglanostat in multiple indications, including investigator-sponsored trials. Our partnered Arginase Inhibitor Program is ongoing with Insight, where we have a number of clinical trials evaluating CB1158 for the treatment of cancer. While we remain committed to and confident in the 1158 development program, we have decided to opt out of our co-development obligations at this time, effective September 30, 2020, as permitted under the terms of the INSIGHT agreement, in order to focus our resources on our own internal development programs. As a result of our decision to opt out, INSIGHT will pay all costs to develop 1158. Arginase inhibitors also have potential in the treatment of cystic fibrosis. And accordingly, we selected CB280, a unique oral arginase inhibitor, for the treatment of this patient population. In November 2020, we announced that we were awarded up to $2.4 million from the Cystic Fibrosis Foundation to support clinical development of CB280. And we are grateful to the Cystic Fibrosis Foundation for their support, and we're pleased to be working with them. We have a broad pipeline and a productive R&D team, and we remain focused on producing novel drug candidates with the potential to be highly differentiated new therapies in areas of unmet need. And with that, I will pass the call over to Keith for additional details on our clinical program.