CytomX Therapeutics, Inc.

Good afternoon, everyone. Thank you for standing by. Welcome to the Cytomics Therapeutics First Quarter 2023 Financial Results Call. Please be advised that today's call is being recorded. I would now like to hand the call over to your host today, Chris Ogden, Cytomics Senior Vice President, Finance and Accounting. Please go ahead.

Thank you. Good afternoon, and thank you for joining us. Before we begin, I would like to remind everyone that during this call, we will be making forward-looking statements. Because forward-looking statements relate to the future, they are subject to inherent uncertainties and risks 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 sec.gov. We undertake no obligation to update any forward-looking statements, whether as a result of new information future developments, or otherwise. Earlier this afternoon, we issued a press release that includes a summary of our first quarter 2023 financial results and highlights recent progress at Cytomix. We encourage everyone to read today's press release and the associated materials, which have been filed with the SEC. Additionally, the press release, a recording of this call, and our SEC filings can be found under the Investors and News section of our website. With me on the call today is Dr. Sean McCarthy, Cytomix's Chief Executive Officer and Chairman. Sean will provide a business and pipeline update before I walk through the financials for the first quarter. With that, I'll now turn the call over to Sean.

Thanks, Chris. Good afternoon, everyone. Thanks for joining us for an update on recent progress at Cytomix. On today's call, I'll provide an update on the company's pipeline progress and the continued execution towards our key priorities for 2023 before opening up the call to Q&A. At Cytomix, we believe that as biologic anticancer therapies become more and more potent, the need for localizing empowered modalities such as antibody drug conjugates, T-cell engagers, and cytokines into cancer tissue becomes increasingly important as a way to improve therapeutic window. Indeed, we believe that localization will be the future of biologics. Cytomix's vision is to transform lives with safer, more effective therapies. We aim to realize our vision for the benefit of patients by leveraging our ProBody platform to create high-impact therapeutics that are localized to disease tissue, thereby reducing systemic toxicities and maximizing overall benefit. Our versatile platform for protease-based, conditionally-activated biologics has strategically positioned our company and pipeline at the intersection as some of the most promising areas of oncology research and development. And I'm excited to walk through the progress of the company during the first quarter of 2023. Throughout Q1, we continue to advance our diversified portfolio of innovative pro-body therapeutic candidates for the treatment of cancer while ensuring disciplined resource allocations. Psychonomics entered 2023 with robust financial resources, positioning the company to execute towards multiple milestones over the next 12 to 24 months. We remain intensely focused on executing towards these milestones, with CX904 continuing to progress in phase one, and IND enabling activities for CX2051 and CX801 remaining on track, with IND filings projected for Q4 this year. With more than 15 internal and partner programs, we are well positioned to deliver meaningful value to patients through the continued progression of our pipeline. Before moving to a review of our pipeline, I'd like to start by taking just a moment to congratulate Dr. Marcia Balvin on her promotion to Chief Scientific Officer of Cytomix, announced today. Marcia joined Cytomix in 2018 as Head of Oncology Research and has since played a vital role in the translation of key learnings from our first wave of clinical programs into the next generation pro-body candidates that make up our current pipeline. Marcia is a key driver of our research, drug discovery, and translational strategies, and has also been central to our continued business development success. My colleagues and I look forward to continuing to work closely with Marcia as we maintain our leadership position in biologics localization through conditional activations. Now moving to our pipeline, I'd like to start with our significant R&D activity in the area of T-cell engaging bispecifics. T-cell engagers hold enormous promise for the treatment of solid tumors. However, the very potency of this modality can lead to widespread activation of the immune system, imposing constraints on therapeutic window. Localization of the powerful anti-cancer activity of this class of drugs could unlock great potential for patients by enhancing therapeutic window, and we at Cytomics, with the support of our partners, believe that the ProBody platform could be ideally suited to addressing this challenge. Our lead program in this area is CX904, a clinical stage ProBody T-cell engager targeting EGFR and CD3, partnered with Amgen in a global co-development alliance. EGFR is a highly validated and broadly expressed cancer target, And we see a compelling opportunity to leverage EGFR target expression as an address to localize and harness anti-tumor T cell responses preferentially to the tumor microenvironment. Our previous work on EGFR published in Science Translational Medicine demonstrated that marking of the EGFR therapeutic antibody, cetuximab, substantially reduced side effects commonly associated with EGFR therapy. This work opened a window to explore empowered anti-EGFR strategies, and CX904 leverages this approach. We're making steady progress with CX904 in the clinic. We successfully treated our first patient in May 2022, and the dose escalation portion of the study continues to advance. We have completed the initial accelerated dose titration phase of the study, which allowed for single patient cohorts, and we're now enrolling into the 3 plus 3 phase. The primary goal of dose escalation is to assess safety and reach dose levels and exposures by the end of 2023, at which enrollment into backfill cohorts in certain EGFR-positive tumors can begin. In 2024, a key milestone will be the determination of our phase two dosing strategy and potential initiation of expansion cohorts. This decision will be taken in collaboration with our partner, Amgen. We look forward to providing additional CX904 updates later this year. Continuing our work in T-cell engagers, we were also delighted to share recently that our partner, Astellas, nominated the first clinical candidate under our collaboration, triggering a $5 million milestone payment to Cytomix. This program is advancing to IND-enabling activities at Astellas. Cytomix and Astellas are also collaborating on additional T-cell engager programs, And Cytomix is eligible to receive future preclinical, clinical, and commercial milestones across these programs, and also retains the option to certain U.S. development and commercial rights. We look forward to providing additional updates regarding the Astellas collaboration as these programs progress. We've also been busy recently kicking off our collaboration with Regeneron in bispecific immunotherapies. Regeneron, of course, brings tremendous scientific depth to our alliance, and we're excited to be combining our technologies with the goal to widen the therapeutic window for potentially paradigm shifting next generation immunotherapy. We look forward to continuing to make expeditious progress in this new alliance. Moving now to our upcoming INDs for the next generation molecules, CX2051 and CX801. These programs incorporate the continuing evolution and advancement of our science and platform building on our prior work in the clinic. Starting with CX2051, our wholly owned conditionally active pro-body ADC targeting epithelial cell adhesion molecule, or EPCAM, also known as TROP1. EPCAM has been regarded as a high potential target for decades and has been clinically validated by others in oncology. However, clinical activity has only been achieved with local administration, for example, in non-muscle-invasive bladder cancer. CX2051 is tailored to optimize the therapeutic window for EPCAM-expressing epithelial cancers by matching the target with payload mechanism of action and tumor sensitivity. We've optimized protease cleavability of the mask for this molecule and selected a camtothecin derivative as the payload for the program, a topoisomerase I inhibitor from the TCAN class. The TCAM payload class has shown exciting clinical results with ADCs, including NHER2 and Tredelvi, and we think this payload is an optimal choice for this program. In preclinical studies, CX2051, when systemically administered, has demonstrated a wide predicted therapeutic index and strong activity in multiple tumor xenograft models, including colorectal cancer. We anticipate filing an IND for this novel ADC in Q4 this year, and advancing the program into the clinic in 2024. Moving to CX801, our dually masked interferon alpha 2B, the lead program within our broad efforts in the cytokine field. We believe there's enormous potential to harness the powerful anti-cancer activity of cytokines by using our localization strategies to direct their activity towards tumor tissue and away from systemic immune system activation. Interferon-alpha 2B is an approved immunotherapeutic that has demonstrated clinical activity in multiple cancer types. Interferon-alpha stimulates antigen-presenting cells to activate cytotoxic T cells and may combine effectively with checkpoint inhibition, offering tremendous potential to enhance immunotherapy responses and unlock checkpoint refractory and or resistant cancers. Interferon-alpha also has direct tumor cell killing activity, providing a dual mechanism of action. However, the powerful anti-cancer activity of interferon alpha has thus far been difficult to harness due to its systemic toxicity. Preclinically, CX801 has demonstrated a wide therapeutic index with an enhanced tolerability profile compared to unmasked interferon, along with preferential activity in the tumor microenvironment. We believe CX801 has the potential to become a unique centerpiece of combination therapy for a wide range of tumor types, And we aim to rapidly advance this potentially best-in-class program towards clinical evaluation with an IND filing targeted for Q4 this year and clinical initiation in 2024. We'll be providing an update on our preclinical evaluation of CX801 at the International Cytokine and Interference Society Guest Symposium at AAI this weekend in Washington, D.C. during which we will also be introducing our exciting work on a new wholly-owned cytokine program focused on conditionally active localized versions of interleukin-15. Turning now to our partnership with BMS, in February of this year, BMS announced that they would be prioritizing and advancing from phase one to phase two the anti-CTLA-4 non-feucosylated probody, BMS-986288. BMS continues to enroll into the Phase 1-2 study, evaluating 288 as monotherapy and in combination with NEVO in solid tumors. And they recently opened a new study arm, evaluating the triplet of 288, NEVO, and regorafenib in third-line or later colorectal cancer. We continue to be excited to have the ProBody platform as a leading edge of their CTLA-4 strategy, as well as to continue to collaborate on several earlier stage ongoing research programs. Let me now turn briefly to our work on CD71, the transparent receptor. At Cytomics, we've had a longstanding interest in leveraging the unique molecular properties of CD71 as an anti-cancer target due to its rapid internalization rate and ability to transport ADCs and other therapeutic modalities into cells. Our CX2029 program, a pro-body ADC previously partnered with AbbVie, has shown encouraging clinical activity, including a 21% overall response rate in late-stage metastatic squamous esophageal cancer. Cytomics recently regained full rights to the CD71 target from AbbVie and has an exclusive option to reacquire the full rights to CX2029. We're assessing next steps for our CD71 program, including potential partnering and additional clinical studies for CX2029, and also next generation strategies for targeting CD71. We'll provide further updates in due course. Finally, I'd like to briefly discuss our partnership with Cytovix's newest partner, Moderna. As a core component of our business model, we've leveraged strategic partnerships to extend the reach of our science, broaden our pipeline, and bring important non-diluted capital into the company. This collaboration is yet another proof point of the validation of Cytomic's scientific expertise and platform breadth, which has now been extended to mRNA. Work is well underway with this important new partnership, which includes programs both in and outside of oncology. We look forward to making progress with Moderna in these novel areas of R&D. With that, let me turn the call over to Chris to cover the financials for the quarter. Thank you, Sean.