Calithera Biosciences, Inc.

Ladies and gentlemen, thank you for standing by and welcome to the Calithera Biosciences, a third quarter earnings conference call. At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question and answer session. To ask a question during the session, you will need to press star one on your telephone keypad. If you require any further assistance, please press star zero. I would now like to hand the conference over to your speaker today, Stephanie Wong. Thank you. Please go ahead, ma'am.

Thank you, Operator. Good afternoon, everyone. Welcome to our third quarter 2021 conference call. Joining me today are Susan Molyneux, Founder, President, and CEO, and Emil Curiaco, Chief Medical Officer. Earlier this afternoon, we issued a press release which included an overview of our third 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 provision under the Private Securities Litigation 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 representative 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 third quarter 2021 conference call. And a special welcome today to Emeril Kriakos, who is joining us in his new role as Chief Medical Officer. and we'll be presenting later in this call. We could not be more excited to embark on this next chapter with Emil. Speaking of the next chapter, last month we strengthened our precision oncology pipeline with the acquisition of Sipanacertib and Mivivotinib from Takeda. As a reminder, Sipanacertib is a dual TORC1-2 inhibitor that targets a key survival mechanism in KEEP1 Nrf2 mutated tumors. which has the potential to be the first treatment for nerve-mutated squamous non-small cell lung cancer. As a next-generation TORC inhibitor, Sipanacertib provides dual inhibition of the TORC1 and TORC2 complexes and has demonstrated durable single-agent responses and clinical benefit in patients with relapsed refractory nerve-2-mutated squamous non-small cell lung cancer with a well-tolerated safety profile. Myvovotinib is a sick inhibitor with the potential to be a best-in-class drug in non-Hodgkin's lymphoma, as well as a first-to-market therapy for patients with DLBCL whose tumors harbor MyD88 or CD79 mutations. Myvovotinib has shown compelling single-agent activity in relapsed refractory NHL patients in completed Phase I-II studies. We plan to initiate Phase II studies of both cipanacertib and migravotinib in the first quarter of 2022. Additionally, last week we announced the decision to discontinue the keepsake trial of teloglanostat in non-squamous, non-small-cell lung cancer following an interim analysis of 40 patients. We have no plans to continue the development of teloglanostat internally at this time. We remain committed to developing targeted therapies for patients with difficult-to-treat cancers with the advancement of both cipanacertib and libivotinib in biomarker-defined populations of squamous non-small-cell lung cancer and diffuse large B-cell lymphoma, respectively. Last week, at the North American Cystic Fibrosis Conference, we presented interim data from the Phase Ib study of CB2AB, our arginase inhibitor. In the presentation, we reported that CB280 was well-tolerated and showed linear pharmacokinetics and robust dose-related pharmacodynamic effects. Additionally, we saw encouraging trends in disease biomarkers, including increased fractional exhaled nitric oxide, or pheno, and decreased sweat chloride. The current data substantiates the proposed mechanism as a rational approach for treating CF. The poster can be found on our website. Finally, as we disclosed on Friday, we have promoted Emil Cariacos from Vice President and Head of Clinical Development to succeed Keith Orford as CMO. In addition, we have strengthened our Board of Directors with the addition of Keith. I would like to take this opportunity to thank Keith for his contributions over the last seven years and to congratulate Emil on his promotion. Emil has been a part of our team for the last four years, and was an integral part of the diligence team that evaluated Sipanacertib and Mivivotinib prior to our acquisition of these assets. This has been a transformational year for Califera. As we prepare to close out 2021 and enter 2022, we look forward to exciting times ahead. We will begin the new year with a keen focus on precision oncology and two new, highly compelling clinical development programs. We plan to initiate the phase two studies of cipanacertib and mizovotinib in the first quarter and look forward to updating all of you on our progress. And with that, I will pass the call over to Emil for additional details on our clinical self-program.