Calithera Biosciences, Inc.

Ladies and gentlemen, thank you for standing by and welcome to CaliFair Biosciences 1Q22 Earnings. At this time, all participants are in a listen-only mode. Later, we will conduct a question and answer session and instructions will follow at that time. If anyone should require assistance during the conference, please press star zero on your touchtone telephone. I would like to turn the conference over to your host, Ms. Stephanie Wong. Please go ahead.

Thank you, Grace. Good afternoon, everyone. Welcome to our first quarter 2022 conference call. Joining me today are Susan Molyneux, founder, president, and CEO, and Emil Curiakos, chief medical officer. Earlier this afternoon, we issued a press release which included an overview of our first quarter 2022 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 Litigation Reform Act of 1995. Actual results made differ materially from those indicated by these forward-looking statements as a result of various important factors, including those discussed in the risk factors 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 for today's conference call. CalSER is off to an exciting start in 2022 as we continue to advance our pipeline of investigational small molecule oncology compounds, to address the needs of biomarker-defined patient populations. We also strengthened our balance sheet with the close of our underwritten public offering of $10 million in gross proceeds in April of this year, resulting in $8.5 million of net proceeds after deducting underwriting discounts, commissions, and offering costs. Focusing on our clinical pipeline, we have made significant progress in completing the transfer of myvavotinib and sepamsertib materials from Millennium Pharmaceuticals, a subsidiary of Takeda Pharmaceutical Companies, to Calithera, and are well into site startup activities for Phase II monotherapy trials for each compound. We remain on track to begin enrollment in these trials in the second quarter of this year and expect to share data by the first quarter of 2023. We believe that by focusing on well-characterized genetic vulnerabilities with molecules that have already shown single-agent activity, we will be able to generate Phase II data with targeted, efficient study designs and devise potential paths for rapid approval in genetically defined patient populations. Turning to our preclinical pipeline, we have continued to advance our internally discovered preclinical pipeline of synthetic lethality targets, most notably VPS4A and VPS4B, which are paralog genes where loss of one or the other paralog in cancer cells is synthetically lethal. In April, we presented data describing VPS4A inhibitors at the American Association for Cancer Research, or AECR, 2022 annual meeting. The presented poster detailed our discovery of what we believe to be the first active on-target VPS4 inhibitors. Emma will describe our findings in further detail. We are continuing to advance multiple inhibitors in series through lead optimization and look forward to updating you on our progress as they advance toward first-in-human clinical studies. In February of this year, we also received good news from our partner, Antigen Investment, who announced the approval of a first-in-human study of ATG037, formerly CB708, in patients with locally advanced or metastatic solid tumors. ATG-037 was discovered by Calisera, and in May of 2021, we entered a license agreement with Antigen, where we granted them an exclusive worldwide license to develop and commercialize ATG-037, which is a CD73 inhibitor. Under this agreement, Calisera received an upfront payment of $3 million and may receive potential development, regulatory, and sales milestones of up to $250 million. I would like to announce also that we have decided not to pursue further development of CB280 in CF cystic fibrosis at this time. We will dedicate our resources towards our oncology programs. While CB280 showed encouraging safety and biomarker data in the completed phase one study in CF patients, we came to this conclusion after reviewing our data and in addition evaluating the impact of recent significant changes in the CF therapeutic and regulatory landscape. And now I will pass the call over to Emil to go into additional details on our program.