CytomX Therapeutics, Inc.

Good afternoon, ladies and gentlemen. Thank you for standing by, and welcome to Cytomix's Therapeutics Third Quarter 2021 Financial Results Call. Please be advised that today's call is being recorded. I'll now hand the call over to your host for today, Chao Cheng, Cytomix's Vice President of Investor Relations and Corporate Communications. Sir, please go ahead.

Thank you, Jesse. Good afternoon, and thank you for joining us. With me today are Dr. Sean McCarthy, Cytomics' President, Chief Executive Officer and Chairman, and Carlos Campoy, Chief Financial Officer. Earlier today, we issued a press release that includes a summary of our third quarter 2021 financial results and highlights the important progress we made during the quarter. We encourage everyone to read today's press release and the associated materials, which have been filed with the SEC. Additionally, the press release and the recording of this call can be found under the Investors and News section of our website at sitomics.com. During today's call, we will be making forward-looking statements because forward-looking statements relate to the future. They are subject to inherent uncertainties and risks, including the uncertainties surrounding the COVID-19 pandemic that are difficult to predict and many of which are outside of our control. Important risks and uncertainties are set forth in our most recent public filings with the SEC at scc.gov, including our Form 10-Q filed today. We undertake no obligation to update any forward-looking statements, whether as a result of new information, future developments, or otherwise. With that, I'd like to turn the call now over to Sean.

Thank you, Chau, and good afternoon, everyone. Thanks for joining us today for an update on recent progress and developments with our clinical and preclinical programs and our company operations. At Cytomics, we are dedicated to destroying cancer differently. Leveraging our ProBody technology platform, we have created a robust and differentiated pipeline of novel, potential first-in-class and best-in-class conditionally activated biologics. Conditionally activated biologics offer much promise for the treatment of cancer, and Cytomix's ambition is to discover, develop, and commercialize more effective and safer therapies. The lead programs in our broad development pipeline are the Conditionally Activated Antibody Drug Conjugates, CX2009-Pralizatamab-Raptanzine, directed towards CD166, and CX2029, directed towards CD71, the transferrin receptor. These two potentially first-in-class assets both target novel tumor antigens and are currently being evaluated in Phase II studies. Polyazetamab is under evaluation in a three-arm Phase II study focused on HER2 non-amplified breast cancer with initial data readouts anticipated in 2022. Arm A of this study is focused on hormone receptor-positive disease. Arm B is focused on triple-negative breast cancer. And Arm C is focused on triple-negative breast cancer in combination with our proprietary PD-L1 inhibitor, pacmelamab. All three arms of this study are open and enrolling, and enrollment accelerated in Q3, with more than 30 sites actively recruiting patients, including additional study centers in Spain and South Korea. Moving now to CX2029, targeting CD71, which is being studied in four expansion cohorts, building on our previously reported phase one dose escalation study, where we observed promising clinical signals in squamous non-small cell lung cancer and squamous head and neck cancer. Our ongoing study is the expansion phase of a Phase I-II study, evaluating CX2029 in these two indications and also in esophageal-gastroesophageal junction cancers and diffused large B-cell lymphoma. Each cohort aims to enroll up to 25 efficacy-evaluable patients, treated at the recommended phase two dose of three mgs per gig every three weeks. CX2029 is partnered with AbbVie under a global co-development agreement, with Cytomix executing the program through clinical proof of concept. Patient enrollment for the expansion phase continued in the third quarter, and we remain on track to announce initial data from the lung and head and neck cohorts of this study next month. I want to take a few moments to highlight the potential opportunity for CX2029 in these tumor types. Lung cancer is the leading cause of cancer death worldwide with approximately 2.2 million new cases globally in 2020 and 225,000 of those in the United States. Non-small cell lung cancer is the most common type of lung cancer and accounts for about 85% of all cases. Squamous non-small cell lung cancer, which represents about 30% of non-small cell, is a devastating, difficult-to-treat form of the disease. Five-year survival rate for patients with metastatic disease is less than 5%, and it's in this setting that we are evaluating the activity of CX2029 as a novel therapeutic option. Head and neck cancer was diagnosed in nearly 750,000 individuals worldwide in 2020. Of these, around 66,000 cases occurred in the U.S., where more than 14,000 patients died from the disease that year. The disease usually begins in the squamous cells that line the mucosal surfaces of the head and neck, including the paranasal sinuses, nasal cavity, oral cavity, pharynx, and larynx. Two-thirds of patients with head and neck cancer are diagnosed in the advanced stages, and more than half of those treated eventually relapse. Median survival for squamous head and neck cancer patients with metastatic relapse is under one year, and new treatments are urgently needed. As I mentioned earlier, we remain on track to announce our initial expansion phase data for CX2029 in these two areas of significant unmet medical need in December. I would now like to move to earlier Cytomics programs and new applications of our versatile technology, starting with CX904, our first conditionally activated T-cell bispecific antibody. DX904 targets the epidermal growth factor receptor, or EGFR, on tumor cells and CD3 on T cells, and is partnered with Amgen. EGFR is a highly validated and broadly expressed tumor target that confers many opportunities in oncology. Multiple anti-EGFR therapeutics are currently in use, including targeted small molecules and the anti-EGFR monoclonal antibodies, cetuximab and panetumumab. Anti-EGFR antibodies are approved in only a limited set of cancer types, yet EGFR is expressed in 5 of the 10 highest incidence cancers and remains a target of high interest for the development of new biologics. The challenge with leveraging EGFR as a target for T-cell engagers is that the broad distribution of the target on normal tissues precludes the use of conventional strategies due to widespread toxicities at low doses. We have previously presented preclinical data from Cytomix showing that our conditional activation technology has the potential to improve the therapeutic window of an EGFR CD3 T-cell engager, and we are on track to submit an IND to CX904, a duly masked bispecific, to the FDA before the end of this year. Within our angina alliance, Cytomix is responsible for IND filing and clinical execution for CX904 through initial clinical proof of concept. Another exciting and emerging area for the Cytomix platform is the application of our proprietary conditional activation technologies to the field of cytokines. To that end, we have engineered a conditionally activated interferon alpha 2B for tumor-selective biological activity. Interferon alpha was, in fact, the first immunotherapy to be approved more than three decades ago, and we believe much potential remains to be realized by harnessing the potent immune-modulating activity of this pleiotropic cytokine. As we've previously announced, preclinical characterization and improved therapeutic index of the dually masked interferon alpha 2B will be presented next weekend at CITC in Washington, D.C. This work not only demonstrates the potential of the cytomics platform to improve the therapeutic window for this potent anticancer therapy, but also serves as a proof of concept for the application of our technology to cytokines broadly an opportunity that we aim to pursue aggressively. I'll now hand the call over to Carlos.