11/7/2023

speaker
Conference Operator
Call Operator

Good day, and thank you for standing by. Welcome to the Cytomic Therapeutics third quarter 2023 financial results. 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 a session, you will need to press star 101 on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question, please press star 101 again. Please be advised that today's conference is being recorded I would now like to hand the conference over to speaker today, Chris Ogden, Senior Vice President, Finance and Accounting. Please go ahead.

speaker
Chris Ogden
Senior Vice President, Finance and Accounting

Thank you. Good afternoon, and thank you for joining us. Before we begin, I would like to remind everyone that during this call, we'll be making forward-looking statements. Because forward-looking statements relate to the future, they're 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 third quarter 2023 financial results and highlights recent progress at Cytomix. We encourage everyone to read today's press release in 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 introductory comments on Cytomix's progress and key milestones before we cover our pipeline progress and financials for the third quarter. With that, I'll now turn the call over to Sean.

speaker
Dr. Sean McCarthy
Chief Executive Officer and Chairman

Thanks, Chris, and good afternoon, everyone. Thanks for joining us for an update on Cytomix's continued progress in 2023. At Cytomix, we are highly focused on the discovery and development of novel cancer medicines utilizing our probody therapeutic platform to localize potent biologic modalities into disease tissue via conditional activation, increasing therapeutic index, and offering new options for patients. Given the continued challenging external environment for biotech, I'd like to start with an overview of the strong fundamentals of cytomics today, with three areas of particular focus, outlining why we believe we are very well positioned as we move towards 2024 and beyond. Firstly, our pipeline. Cytomics is active across our pipeline in key areas of current oncology R&D. Two of the biggest highlights recently at ESMO 2023 were new breakthroughs in the use of antibody drug conjugates and T-cell engagers. ADCs and T-cell engagers are poised to be therapeutic platforms with potential to transform the treatment of solid tumors. I'm very pleased to say that for many years, Cytomix has been building significant expertise across these important modalities And we currently have differentiated lead programs in both areas. Our pipeline has never been more relevant or had more potential. 2023 has been a year of intense focus and exceptional execution for Cytomix that has set the stage for key value-creating milestones in 2024 and 2025. Starting with CX904, our ProBody T-cell engagers start targeting EGFR and CD3. Coming out of ESMO last month, there's clear momentum and increasing clinical evidence that T-cell bispecifics can have a meaningful clinical impact in solid tumors. However, a central challenge in this highly potent modality is that the majority of solid tumor targets are also expressed in normal cells, limiting therapeutic window. CX904 is designed to address this challenge for EGFR, which is one of the most highly validated and broadly expressed solid tumor targets. CX904 has continued to advance through Phase 1, and we're in the process of starting to backfill certain cohorts as we continue dose escalation. We remain on track for initial data in the first half of 2024. Our first in-class EPCAM targeting ProBody ADC, CX2051, is on track for IND filing by the end of this year and Phase 1 initiation in 2024. CX2051 is an excellent example of Cytomic's differentiated ability to pursue novel ADC targets. We are particularly excited about EPCAM given its high expression level across multiple tumors, including colorectal cancer, and its prior clinical validation as a target for cancer therapy. We presented the full preclinical profile of CX2051 at World ADC in October, and the presentation can be found on our website. We plan to execute on Phase 1A dose escalation through 2024 and, data permitting, to initiate Phase 1B expansion cohorts in 2025. We have also continued to advance our first pro-body cytokine, CX801, towards the clinic. CX801 is a masked version of interferon alpha 2B for which we see enormous potential as a novel centerpiece of cancer immunotherapy in the future. Last weekend, we presented updated preclinical data at CITC. This presentation is also available on the Cytomix website. IND filing for this program is also anticipated by the end of the year. Continuing in the field of cancer immunotherapy, our partner BMS is advancing the masked non-fuecosylated CTLA-4 program, BMS 986288, in phase two, which includes proof of concept studies in microsatellite stable colorectal cancer and in non-small cell lung cancer. BMS anticipates data will be available from this program in 2024. Taken together, our pipeline is deep, strong, relevant, and poised to drive value inflection in the near term. The second area I'd like to highlight today is our partnerships. Cytomix created the field of protease-based conditional activation more than a decade ago, and our substantial and consistent investments in our platform technology have allowed us to attract many high-quality partners. We currently have alliances with Moderna, Regeneron, Astellas, Amgen, and BMS that each bring value to Cytomix in the form of technical validation, increasing the reach of our platform, and providing non-diluted financing. Together with our partners, Cytomix today has more than 15 active R&D programs. In addition to upfront cash infusions from these partnerships and potential future product royalties, each partner program has the potential for near and long-term cash milestone payments. Cytomix has a strong track record of earning milestones under our alliances, including most recently a $5 million payment from Astellas for our first clinical candidate nominated in the collaboration. Thirdly, I would like to highlight our strong financial position. Chris will review shortly how we are continuing to manage the financial resources of the company in the context of the challenging external environment. Before handing over to Chris and continuing on the theme of fiscal discipline, I would like to provide a brief update on CX2029, our ProBody ADC targeting CD71. We've been encouraged by the anti-tumor activity we've observed with CX2029 to date. However, based on current priorities, we will not be directing significant additional investment in this program in the near term. Now, let me turn the call over to Chris, who will walk you through our financials.

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