Calithera Biosciences, Inc.

Good day, ladies and gentlemen, and thank you for standing by. Welcome to the Califero Biosciences third quarter 2022 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 1 1 on your telephone keypad. At this time, I would like to turn the conference over to Ms. Stephanie Wong. Ma'am, please begin.

Thank you, operator. Good afternoon, everyone, and welcome to our third quarter 2022 conference call. Joining me today are Susan Molino, founder, president, and CEO, and Emil Kariakos, chief medical officer. Earlier this afternoon, we issued a press release, which included an overview of our third quarter 2022 financial and operational results, which can be accessed through our website at califera.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 Litigation and Reform Act of 1995. Actual results may differ materially from those indicated by these forward-looking statements and as a result of various important factors, including those discussed in the risk factor section of our period clients 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 for today's conference call. Last quarter, we announced the initiations and enrollment of the first patients in our Phase II clinical trials of Mivovotinib in relapsed refractory non-GCB diffuse large B-cell lymphoma, or DLDCL, and Sipanacertib in relapsed refractory Nrf2-mutated squamous non-small cell lung cancer. While patient enrollment is progressing, there have been site activation delays that have affected both trials. These delays have caused enrollment to fall behind our anticipated timelines. And as a result, we do not expect initial data to be available until mid 2023, compared with our earlier projection of Q1. Also, based on our current operating plan, we believe we have sufficient cash to fund our operations into the second quarter of 2023. In order to extend our cash runway, we are evaluating all options for our programs, including strategic collaboration or licensing agreements, and are actively considering the sale of certain programs. We continue to believe strongly in the potential of Sipanacertib and Mivivotinib in their respective target patient populations and are committed to taking all steps possible to allow for their continued clinical development so that we can bring these therapies to patients. As we announced last month, Sipana Certib was granted FDA fast track designation for the treatment of adult patients with unresectable or metastatic squamous non-small cell lung cancer, about which Emma will go into further detail shortly. This designation provides us the ability to engage in more frequent dialogue with the FDA, which we believe will be important as we continue the clinical program. It will also give us the opportunity to submit our marketing application on a rolling basis with the potential for priority review. We look forward to working with the agency as we continue to advance this much-needed treatment for a patient population who have typically not benefited from the standard of care due to the mutational status of their tumors. With that said, I will pass the call over to Emil to provide additional details on our program.