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spk02: 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.
spk07: 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.
spk06: 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.
spk08: Thank you, Sean. Phytomics remains in a strong financial position to support our bold clinical and research agenda that Sean just reviewed, which is to maximize the benefit of our conditionally activated therapeutic candidates for people with cancer. As of September 30th, 2021, we had $336 million in cash, cash equivalents, and investments, which we project will fund the operations of the company well into 2023. For the third quarter of 2021, revenue was $18 million, relatively flat when compared to the corresponding period in 2020. R&D expenses increased $5 million to $29 million during the three months ended September 30th, 2021, compared to the third quarter of 2020. The increase was driven by personnel, clinical trial, and consulting and contract expenses, primarily related to prolizetamab and CX2029. GNA expenses were $11 million during the three-month end of September 30th, 2021, an increase of $2.5 million compared to the same period in 2020. The increase was attributable to personnel-related expenses as well as professional services. With that, I'll turn the call back to Shawn.
spk06: Thanks, Carlos. I want to close by emphasizing the leadership position that Cytomix has established in the field of conditionally activated biologics. Across multiple targets and within our broad and deep therapeutic pipeline, we have clearly demonstrated that conditional masking is a versatile approach to enhancing or indeed creating a therapeutic window for high potential cancer treatments, and we see enormous potential in our technology. At Cytomix, we continue to innovate by advancing a novel therapeutic advancing novel therapeutic programs towards the clinic, including CX904, and our emerging work in the field of conditional cytokines. Our partner, BMS, continues to work towards data from a randomized Phase II study, comparing our ipilimumab probody in combination with nivolumab to an ipinivo frontline metastatic melanoma study. I want to thank our clinical team, whose intense focus has allowed us to make excellent progress towards Phase II readouts for our first-in-class lead clinical programs, that really are pushing the boundaries of ADC drug development by leveraging previously undruggable targets. As we continue to drive the translational science of the ProBody platform and the tumor microenvironment, we're honored and privileged to have Dr. Alan Ashworth join Cytomics Board of Directors. As president of the UCSF Helen Diller Family Comprehensive Cancer Center and former chief executive of the Institute of Cancer Research in the UK, Alan is a world-renowned expert in cancer research and an accomplished global leader in cancer therapy development. We look forward to Alan's contributions as we advance our clinical pipeline towards key phase two inflection points, and as we continue to lead the field of conditionally activated therapeutics. With that, operator, please open the call up for Q&A.
spk02: Thank you, speakers. Participants, we will now begin the question and answer session. To ask a question over the phone, you may press the star key followed by the number one. to withdraw your request, you may press the pound key. Again, that's star one to ask a question or the pound key to withdraw your request. Speakers, our first question is from the line of Mara Goldstein of Mizuho. Your line is now open.
spk01: Hi. This is support for Mara Goldstein. My question is on CX2029. I mean, so first of all, you mentioned that there will be data in December. Have you already identified the venues for that? And secondarily, to what extent do you think this data set would give clarity on how the toxicity of this compound can be managed? Thank you.
spk06: Yeah, hi, thanks for the question. So first of all, or questions, I should say. First of all, with regard to venue, yes, so we're working towards announcing data next month. And that will be via a press release and associated conference call. In terms of the, you know, what to expect, I'll comment on the safety side also maybe a little more broadly. You know, this will be initial data. This will be a first look at, you know, a meaningful number of patients treated at the RP2D of three mgs per gig Q3 week. The goal in each of the cohorts of the expansion phase is to enroll 25 efficacy-evaluable patients, and we expect for these first two cohorts to be able to present meaningful progress towards that goal. It will include likely a mix of patients with one or more post-baseline scans and, of course, a follow-up of patients with regard to the management the incidence and management of anemia, which is the side effects that we're obviously tracking most closely, given what we learned in phase one.
spk05: Very thanks.
spk02: Next question is from Anupam Rama of JP Morgan. Your line is now open.
spk04: Thanks so much for taking the question. Just two quick ones from me. First one, 2009, you guys noted the site expansion. Is there any plans to further expand your sites? And what type of enrollment sort of progress and trajectory might you need to give us a little bit more granular timelines for data than broadly 2022? That's the first question. The second one, follow on to the first one, which is, I guess, thinking about 2029, What would get you excited as kind of a win scenario? Thanks so much. Yeah, thanks for the questions.
spk06: So regarding 2009, we're very pleased with the progress in Q3 with site activation and ongoing enrollment. We're not ready to give additional specifics of enrollment numbers, but we are pleased with the progress that the team has made over the last few months. We will be adding additional sites in the coming months as well. But for now, our guidance continues to be data in 2022. We'll be working to refine that as we move into the new year. Regarding 2029, in the two expansion cohorts that we're planning to present updates on next month in head and neck and lung, obviously we're in the, you know, second, third line setting here. and a significant unmet need. You heard our comments on the nature of the unmet need in these patient populations. And, you know, we're thinking, broadly speaking, impact on these diseases with durations of response of, you know, four to six months would be terrific. Response rates in the 20 plus percent range would be great. given that these patients have a few options and also given that this is a novel drug candidate against a very unique target that intrinsically makes it a first-in-class therapeutic. So we'll see what we get, but that's broadly how we're thinking.
spk04: Thanks so much for taking our questions.
spk06: My pleasure.
spk02: Next question is from Roger Song of Jefferies. Your line is now open.
spk09: Great. Thank you for taking my question. The first question also related to 2029. I think Sharon already mentioned the bar of what data you will think it will be. It's a weak scenario, which is kind of a resonate my thinking as well. And maybe moving a step further is this is like a monotherapy setting And if, given the tox safety profile you have been seeing and the potential efficacy in this setting for those patients, what kind of a combination therapy you potentially will be considering?
spk06: Yeah. Hi, Roger. Thanks. Great question. You're right to point out that, of course, right now we're laser focused on characterizing the monotherapy activity of 2029. And it's not lost on us, of course, that this is an agent that could very well be combined with a range of different agents in the future. There's nothing really that we see in the anemia side effect that would preclude the types of combinations that one might think of pursuing. So we don't see that as a particular barrier. I don't want to comment on specific combinations. I'm sure you can think about what they might be. But we do know that ADCs are combinable with a range of different mechanisms, and we'll be interested to explore those in the future. I wanted to just also restate, coming back to the question previously regarding you know, what success looks like. I wanted to just restate what we saw in phase one dose escalation with these two indications, and starting with lung, where with squamous lung in phase one dose escalation, we had four patients enrolled. One of those patients was treated at one mcpc, which we didn't think would be an efficacious dose based on all of the modeling that we had done. In the three that received two mcpc or above, we saw two confirmed PRs and one stable disease. So, you know, certainly promising, and that's the basis that led to the expansion that we're running right now in these additional 25 patients. In head and neck, we had eight patients enrolled in, squamous head and neck, eight patients enrolled in phase one dose escalation, treated at two mgs per kg or above. We saw six patients, of the seven efficacy available, we saw six with stable disease and one with a very deep and extended PR that actually lasted for more than six months. And so just that's the basis, of course, on which we now are running these expansions. And, you know, we'll see what we see when we review and present the data next month.
spk09: That's great. I really appreciate all the color. Maybe another question is related to the 904. Yeah, we understand the EGFR is definitely some kind of a higher menu there. Just curious, any kind of additional thoughts around the plan and the tumor types and the timing for the clinical initiation and the potential data?
spk06: Not much more to say there at this point in time. We're pleased with the progress we're making towards IND filing. And on our last call, we did mention that we were working towards a pre-IND interaction with FDA. We had that interaction during Q3. It was highly productive and helpful in helping us continue to shape the IND filing and the phase one strategy. And, you know, we're obviously looking forward to getting that IND filed and getting going in the clinic in 2022.
spk09: Okay. That's great. Thank you. That's all from me.
spk02: Again, participants, it's star one to ask a question or to pound key to withdraw your request. Next question is from Joe Catanzaro of Piper Sandler. Your line is now open.
spk03: Hey, guys. Thanks so much for taking my question. Maybe just another one on CX2029 here, but asking more so about tolerability in the bar there and how we should think about what's the you know, appropriate or reasonable rates of high-grade anemia, transfusion burden, growth factor support? Or should we be thinking more, you know, if the OR and DOR meets the hurdles you just sort of said, then that in itself is indicative of a good tolerability profile? Thanks.
spk06: Yeah, hi, Joe. Great question. Yeah, so let me just talk a bit more broadly about anemia, how we're thinking about it based on the Phase I work. The first thing to say that, and we've said this many times before, that with this drug candidate, the anemia is predictable, reversible, and we believe manageable with several interventions, including transfusions, dose delays, dose reductions, and we continue to explore the opportunities for erythrocyte-stimulating growth factors like darbopoietin, given that this appears to be an effect on early hematopoiesis. It's important to note that there were no events of anemia that led to discontinuation of CX2029 in the Phase 1 study. That's important. We're obviously going to learn a lot more from the expansions, but that's the big picture on anemia. You're right to point out, though, that I would agree with you that it is an important consideration to consider the anemia in the context of the overall profile of the drug as we gain more insight into its single-agent activity.
spk03: Okay, great. Thanks for taking my question.
spk06: My pleasure.
spk02: Thank you, participants. At this time, I'll now hand the call back over to Chao Cheng for his closing remarks.
spk07: On behalf of the executive team, I'd like to thank you all very much for joining us this afternoon. We look forward to updating you in the future on our ongoing progress.
spk02: Ladies and gentlemen, this concludes today's conference call. Thank you all for participating. You may now disconnect, and have a great day.
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