11/8/2022

speaker
Operator
Teleconference Operator

Good day, and thank you for standing by. Welcome to the Cytomix Therapeutics third quarter 2022 financial results call. At this time, all participants are in listen-only mode. After the speaker's presentation, there will be a question and answer session. To ask a question during the session, you will need to press star one one on your phone. You will then hear an automated message advising your hand is raised. Please be advised that today's conference is being recorded. I'd now like to hand the conference over to your today's speaker, Chris Ogden, Senior Vice President of Finance and Accounting. The floor is yours.

speaker
Chris Ogden
Senior Vice President of Finance and Accounting

Thank you. 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 third 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, the press release and a recording of this call can be found under the Investors and News section of our website. With me on the call today is Dr. Sean McCarthy, Sytomix's Chief Executive Officer and Chairman. Sean will provide a business and pipeline update before I walk through the financials for the third quarter. With that, let me turn the call over to Sean.

speaker
Dr. Sean McCarthy
Chief Executive Officer and Chairman

Thank you, Chris, and good afternoon, everyone. Thanks for joining us for an update on recent progress at Cytomix. Our mission at Cytomix is to destroy cancer differently, and we're focused on leveraging our ProBody platform to deliver differentiated medicines for people with cancer. Cytomix clinical achievements and learnings to date continue to highlight the broad applicability and scientific depth of our platform. ProBody Therapeutics are designed to achieve conditional activation of biologic therapies in tumor tissue, and we now have clinical experience with this important approach in more than 500 patients, many of whom have significantly benefited. Importantly, we have shown the potential of the platform to improve the therapeutic window across multiple biologic modalities, including checkpoint inhibitors, antibody drug conjugates, T-cell bispecifics, and cytokines. These achievements are the result of our deep scientific expertise in biologic masking and in mapping the protease tumor microenvironment. Our continuous learning in the field of conditional activation is central to our conviction that our platform and pipeline has the potential to deliver breakthrough medicines for cancer patients. Conditional activation of biologics is an area of cancer R&D that is increasingly recognized in the industry as an important new frontier. Localization of cancer therapy via conditional activation offers immense promise, and cytomics is at the forefront of this field. Innovation takes time and persistence, and along the company-building journey, to make the biggest difference, we must from time to time take bold, decisive action and prioritize the opportunities most likely to deliver meaningful impact to patients. Last quarter, we made the difficult decision to restructure the company in order to focus our internal resources on our wholly-owned Next Generation Pipeline, and on our partner programs. As a result, Cytomix remains strong, is funded into 2025, and is well positioned for the future. Our current pipeline spans from preclinical phase two across multiple modalities and is addressing many important areas of unmet need in oncology. I'd now like to briefly review our lead programs. I'd like to start with our wholly owned Next Generation Pipeline candidates, CX2051, and CX801. Now, for these programs, we have selected previously validated targets, EPCAM and interferon-alpha-2b, respectively, that have historically been limited in their potential due to systemic toxicities. In the molecular design of CX2051 and CX801, we have incorporated our platform expertise and clinical learnings to optimize predicted therapeutic index in order to potentially broaden the clinical utility of these promising targets through conditional activation. Focusing now on CX2051, EPCAM has been regarded as a high potential oncology target for decades and has been clinically validated by others. However, efforts to generate systemic anti-EPCAM therapeutics have to date not been successful due to toxicities in epithelial tissues. At the World ADC Conference during Q3, we were pleased to unveil CX2051 as our newest conditionally activated ADC. 2051 is tailored to optimize the therapeutic index for EPCAM expressing epithelial cancers by matching the target with payload mechanism of action and with tumor sensitivity. We selected Captathicin, a topoisomerase I inhibitor, as the payload for this program based on the well-characterized profile of this class. and the strong clinical activity observed with topo-1 inhibiting ADCs, including, for example, the recent groundbreaking breast cancer data for N-HER2. At World ADC, our data, presented for 2051, demonstrated a wide predicted therapeutic index and strong preclinical activity and tolerability in multiple preclinical models, including in colorectal cancer. The expression profile of EPCAM and the tumor sensitivity profile of the Captathicin payload provide an exciting clinical path forward for this program, and we anticipate filing an IND for this novel ADC in the second half of 2023. Turning now to CX801, our conditionally activated interferon alpha-2b, the lead program within our broad efforts in the cytokine field. At CITC later this week, we will share preclinical data for CX801, highlighting its potential to improve therapeutic window versus unmasked interferon. Interferon Alpha 2B is an approved immunotherapeutic that has demonstrated clinical activity in multiple cancer types, and we believe provides a potentially superior approach to activating antitumor immune responses to IL-2, IL-12, and IL-15. Interferon Alpha stimulates antigen-presenting cells to activate cytotoxic T cells and combines effectively with checkpoint inhibition, offering tremendous potential to unlock checkpoint refractory and or resistant cancers. However, the powerful anti-cancer activity of interferon alpha has thus been difficult to harness due to its systemic toxicity. For CX801, the data to be presented at CISTI show a wide therapeutic index with an enhanced tolerability profile versus unmasked interferon without limiting its potent anti-tumor effects. Importantly, these data also highlight CX801's preferential activity in the tumor microenvironment as well as the potential for synergistic effects when combined with checkpoint inhibition. 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 the second half of 2023. Moving on now to our clinical stage pipeline, we continue to work intensively with our partners to advance multiple pro-body therapeutic programs. Our work with Bristol-Myers Squibb is making important progress, including with BMS 986249, the pro-body version of ipilimumab. At ESMO in September, BMS presented promising updated Phase I data from an ongoing Phase I-II study in patients with advanced cancers. We are particularly encouraged by the safety profile and clinical activity reported from the Phase I study to date. Both as monotherapy and in combination with nivolumab, 249 appears to be tolerated at higher doses than standard ipilimumab clinical dosing. Clinical activity was demonstrated in multiple tumor types, including melanoma, and a particularly encouraging case study of a response in microsatellite stable colorectal cancer. CTLA-4 continues to be an important target and a foundational immuno-oncology strategy, but CTLA-4 blockade has a narrow therapeutic window. The ESMO 2022 update provides continued evidence for the ProBody platform enabling higher and potentially more efficacious doses of anti-CTLA-4 therapy. BMS continues to evaluate 249 in a randomized Phase II study in combination with NEVO versus IPI plus NEVO in patients with advanced melanoma. The combination is also being studied in advanced hepatocellular carcinoma, castration-resistant prostate cancer, and in triple negative breast cancer. During Q3, BMS also highlighted our collaborative work on CTLA-4 in the CITSE webinar series in a presentation titled Building on the Legacy of Ipilimumab. This presentation focused on the company's portfolio of next-generation anti-CTLA-4 antibodies to which the ProBody strategy is a core focus. BMS also continues to study the non-fucosylated CTLA-4 targeting ProBody, BMS 986288, in Phase 1 both as monotherapy and also in combination with NEVO in patients with advanced solid tumors. This strategy is aimed at enhancing the clinical benefit of ipilimumab through superior APC-mediated T-cell priming. BMS will be presenting a poster at CITC this week focused on the non-masked version of 288, BMS-986218, and this poster will include preclinical data for 288, the probody, which continues to advance in the clinic. We continue to be excited to be playing such an important role in BMS Next Generation CTLA-4 efforts, and we look forward to future clinical updates on these programs over time. Moving on to CX2029, our CD71 or transferrin receptor directed ADC partnered with AbbVie. CD71 has long been recognized as an attractive target for cancer therapy because of its efficiency as an internalizing transporter and because it's highly expressed in many solid and hematologic tumors. However, this target has previously been undruggable due to its expression on many normal tissues. CX2029 is a conditionally activated probody ADC targeted to CD71 that has demonstrated favorable tolerability and encouraging antitumor activity in phase one, and subsequently has advanced into a multi-cohort phase two expansion study. Enrollment into the CX2029 expansion phase is now complete in all three solid tumor types. A data update for the squamous lung cohort is expected in the fourth quarter of 2022. Additionally, data from the esophageal-gastroesophageal junction cancer cohort continue to mature. We anticipate dialogue with our partner, AbbVie, as to the next steps for this program. Thus far on the call, we have discussed the application of our versatile technology to three biologic modalities, ADCs, cytokines, and checkpoint inhibitors. I would now like to move to our fourth modality, T-cell engaging by specific antibodies. Localization of the powerful activity of T-cell engagers is a key goal in cancer R&D, and we believe our platform is very well suited to address this challenge. In September, in cancer research, we published preclinical data demonstrating that a conditionally active bispecific EGFR CD3 probody could expand the safety window while maintaining anti-cancer activity of this potent target combination. This work has led to the clinical candidate, CX904, and we are now well underway with phase one dose escalation for this program with the goal of assessing safety and selecting a go-forward dose for subsequent expansions in EGFR-positive tumor types. CX904 is partnered with Amgen in a global co-development collaboration, and we believe this T-cell engager has broad potential across many cancers, and we look forward to providing future updates. Let me now turn the call over to Chris to provide you with a financial overview for the quarter.

Disclaimer

This conference call transcript was computer generated and almost certianly contains errors. This transcript is provided for information purposes only.EarningsCall, LLC makes no representation about the accuracy of the aforementioned transcript, and you are cautioned not to place undue reliance on the information provided by the transcript.

-

-