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8/4/2022
Good afternoon, everyone. Thank you for standing by. Welcome to the Cytomex Therapeutics Second Quarter 2022 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 for today, Chao Cheng, Cytomex's Vice President, Investor Relations and Corporate Communications. Please go ahead.
Thank you, Yorua. Good afternoon and thank you for joining us. Before we begin, I'd 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 second quarter 2022 financial results and highlights recent developments at the company. We encourage everyone to read today's press release and the associated materials, which have been filed with the SEC. Additionally, Press release and the recording of this call can be found under the Investors and News section of our website. With us on the call today are Dr. Sean McCarthy, Cytomics' Chief Executive Officer and Chairman, and Carlos Campoy, Chief Financial Officer. With that, let me turn the call over to Sean.
Thank you, Chair, and good afternoon, everyone. Thanks for joining us for an update on recent progress at Cytomics. The foundation of our work at Cytomix is to destroy cancer differently. With our innovative ProBody therapeutic platform, we have blazed a new trail in oncology R&D, and it's now generally accepted that the conditional activation of biologics offers tremendous opportunity for the development of new cancer therapeutics. At Cytomix, we firmly believe that our multi-modality ProBody platform has the potential to deliver differentiated medicines for the treatment of people with cancer. To ensure Cytomics remains well positioned for the future, as announced last month, we have made a series of recent changes with the organization to prioritize our R&D investments and capitalize on our extensive clinical experience to date with our platform technology. Our restructured pipeline holds much promise for people with cancer and continues to span preclinical stage to phase two. CX2029 is in the later stages of phase two expansions, and enrollment into the solid tumor cohorts has been completed. Our collaborative work with Bristol-Myers Squibb continues, including the randomized Phase II study of BMS 986249, and we're also well underway with Phase I dose escalation for CX904, our EGFR CD3 T-cell engaging bispecific. In regards to our earlier stage pipeline, our recent decision to deprioritize praluzetamab-ravtanzine now enables us to focus our resources and capital towards two exciting new wholly-owned programs, CX801 and CX2051, and I'd like to spend a few moments focusing on these new opportunities. CX801 is our conditionally-activated interferon alpha-2b, the lead program within our broad efforts in the cytokine field. Interferon alpha-2b is an approved immunotherapeutic that has demonstrated clinical activity in multiple cancer types, and we believe provides an orthogonal and potentially superior approach to cytokines like IL-2, IL-12, and IL-15 in activating anti-tumor immune responses. At the cellular level, interferon-alpha potently stimulates antigen-presenting cells to activate cytotoxic T cells. Furthermore, interferon-alpha combines effectively with checkpoint inhibition and offers tremendous potential to unlock checkpoint refractory and or resistant cancers. Despite its potential, however, the systemic toxicity of interferon-alpha has limited its use to date. We're therefore excited to have created CX801, a conditionally activated masked version of interferon-alpha 2B designed to harness the powerful activity of this potent immune modulator by increasing its therapeutic window. The broad therapeutic window of CX801 was highlighted in our poster presentation at AACR earlier this year, and we aim to rapidly advance this potentially best-in-class program towards clinical evaluation with IND filing targeted for the second half of 2023. Switching now to 2051, CX2051, a conditionally activated antibody drug conjugate targeting EPCAM with potential applicability across EPCAM-expressing epithelial cancers. Epcam has been regarded as a high-potential oncology target for decades and has been clinically validated by others. For example, the locally administered anti-Epcam antibody toxin fusion protein, Opituzumab monotox, has demonstrated robust clinical activity in non-muscle-invasive bladder cancer. However, efforts to generate systemic anti-Epcam therapeutics have, to date, not been successful due to toxicities to epithelial tissues. This is because EPCAM, or epithelial cell adhesion molecule, as the name suggests, is present on the majority of normal epithelial cells, and conventional anti-EPCAM biologics administered systemically have significant dose-limiting toxicities. We're applying the learnings from our clinical studies with pralusatumab, raptanzine, and CX2029 in the design of CX2051, and we'll have more to say about the molecular configuration of this drug candidate in the future. We plan to file an IND for this novel ADC in the second half of 2023. A key theme that connects our two newest programs, CX801 and CX2051, is that both targets have a level of validation that we believe increases the probability of future clinical success, and we are excited to be moving these programs forward. Now returning to our later stage pipeline, where we continue to work intensively with our partners to advance multiple novel programs in the clinic. This past quarter, we introduced into the clinic CX904, the third therapeutic modality from our versatile pro-body platform. CX904, which is partnered with Amgen, is our conditionally activated T-cell engaging bispecific antibody designed to target the CD3 receptor on T-cells and the epidermal growth factor receptor on cancer cells. This target combination is intended to activate anti-tumor T-cell responses in EGFR-positive cancers. In Q2, We treated the first patient with CX904, and phase one dose escalation is ongoing with the goal of assessing safety and selecting a go-forward dose for subsequent expansions. Moving on to BMS986249, our CTLA-4 targeting pro-body candidate, licensed to Bristol-Myers Squibb. CTLA-4 targeted therapy is a foundational immuno-oncology strategy, and treatment with ipilimumab as a monotherapy or in combination with NEVO has resulted in clinically meaningful anti-tumor activity in a variety of malignancies. The durability of responses to anti-CTLA-4 therapy continues to highlight the importance and uniqueness of this target. However, CTLA-4 blockade has a narrow therapeutic window, and we believe that broader potential of CTLA-4 therapy could be realized through the application of our ProBody platform. BMS continues to evaluate 249 in a randomized phase two study in combination with NEVO versus IPI plus NEVO in patients with newly diagnosed advanced melanoma. BMS previously reported phase one safety data for 249 at ASCO 2020, showing the CTLA-4 targeting probody was well tolerated at elevated doses, both as monotherapy and also in combination with NEVO. At ESMO 2022, BMS plans to present updated phase one results for 249 in a poster presentation. In early 2021, BMS extended the evaluation of 249 plus NEVO to advanced hepatocellular carcinoma, castration-resistant prostate cancer, and triple negative breast cancer. And BMS also continues to study BMS 986288, the non-feucosylated CTLA-4 targeting pro-body in a phase one dose escalation study both as monotherapy and also in combination with NEVO in patients with advanced solid tumors. Now continuing on to CX2029, our CD71 or transferrin receptor-directed ADC, which is partnered with AbbVie. Enrollment into the overall CX2029 Phase II expansion study has now met its objectives in all three solid cancer indications, including the gastroesophageal junction cancer cohort. The diffuse large B-cell lymphoma cohort has been deprioritized due to strategic and competitive reasons and did not enroll any patients. A data update for the squamous lung cohort is expected in the fourth quarter of 2022, and data from the esophageal and gastroesophageal junction cancer cohort continues to mature. With that, let me hand over to Carlos, who will provide you with a financial overview for the quarter.
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