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spk05: Good afternoon, ladies and gentlemen. Thank you for standing by. Welcome to the Citamix Therapeutics Second Quarter 2021 Financial Results Call. Please be advised that today's call is being recorded. I would now like to hand the conference over to your host today, Chao Cheng, Citamix Vice President, Investor Relations and Corporate Communications. Please go ahead.
spk06: Thank you, Suzanne. Good afternoon and thank you for joining us. With me today are Dr. Sean McCarthy, Cytomics' President, Chief Executive Officer and Chairman, Dr. Amy Peterson, Chief Development Officer, and Carlos Campoy, Chief Financial Officer. Earlier today, we issued a press release that includes a summary of our second 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 sitomix.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 today. 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, including our Form 10Q 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 would like to turn the call now over to Sean.
spk08: Thank you, Chao, and good afternoon, everyone. Thanks for joining us today for an update on recent progress and developments within our clinical and preclinical programs and operations. At Cytomics, we continue to dedicate ourselves to working towards making a meaningful difference in cancer treatment by being different and thinking differently. We have pioneered an entirely new way to design therapeutic antibodies and other biologic modalities, and we have used our technology to purposefully go after high-potential targets that were previously considered undruggable in order to stand out from the crowd and build long-term value. We're exploiting an Achilles heel of tumor biology to combat cancer in new and unique ways. Our technology, the ProBody platform, is a conditional activation strategy that uses protease-dependent peptide masking. Given that proteases are activated in the tumor microenvironment but tightly controlled in normal tissues, our strategy is designed to reduce antibody binding in normal tissues while maximizing target binding in cancer. During the second quarter, we continue to advance our broad pipeline of probody therapeutics across multiple modalities and cancer types, including our two conditionally activated antibody drug conjugates, or ADCs, Pralizatamab-Raptanzine, also known as CX2009, and CX2029, both of which are currently in phase two clinical investigations encompassing multiple tumor types. Let me begin with CX2029, our CD71-directed conditionally-activated ADC, for which we recently published results from a Phase I first-in-human study in patients with advanced solid tumors. This important work by Cytomix, in collaboration with our partner, AbbVie, has demonstrated for the first time that CD71 can be successfully targeted with a drug-conjugated antibody using our technology. Why CD71? Well, CD71, or the transferrin receptor, has been a very attractive but elusive oncology target for ADC development. It's highly expressed on the vast majority of tumors, since all growing and dividing cells need iron for many metabolic processes. And CD71 is an extremely efficient transport system, fully internalizing antibodies within minutes of binding. However, CD71 was previously deemed undruggable with conventional ADCs, because it's also highly expressed in and vital to normal tissue growth and development. As we have now published in clinical cancer research, in phase one dose escalation, CX2029 was generally well tolerated and produced encouraging anti-cancer activity, notably in patients with squamous non-small cell lung and head and neck cancers, a first for an ADC against this high potential target. These two cancer types are now part of an ongoing four-cohort phase two expansion study. We dosed the first patients in the expansion phase in November 2020, and Amy will give you an update in a few moments on where things stand. Moving on to Pralizatamab-Raptantin, our wholly-owned, first-in-class, conditionally-activated ADC directed toward another novel oncology target, CD166. CD166, also known as activated leukocyte cell adhesion molecule, or ALCAM, is a transmembrane glycoprotein that has been reported to play a role in multiple aspects of tumor biology, including angiogenesis and invasiveness. CD166 is highly expressed on the cell surface of many cancer types and, as such, has attractive molecular properties as an ADC target. However, developing a conventional ADC against CD166 is precluded by its widespread presence on healthy tissues. Our pioneering Phase I clinical work on CD166 has shown that Pralicetamab can achieve clinically meaningful outcomes in patients with different cancer types, including, but not limited to, HER2 non-amplified breast cancer. These results support our current three-arm Phase II study in breast cancer, and we're excited about the potential for this asset in this indication, and more broadly in other CD166-expressing cancers where substantial unmet need remains. Amy will also provide you with more details of the design and status of the Pranidazumab Phase 2 study shortly. Turning now briefly to our work in immuno-oncology and our partner clinical programs with Bristol-Myers Squibb, aimed at broadening the therapeutic window and therefore the clinical utility of anti-CTLA-4 immunotherapy. BMS-986249 and BMS-986288, discovered using the Cytomics platform, are probody versions of different forms of the anti-CTLA-4 therapeutic antibody, ipilimumab. BMS 986249, having successfully completed dose escalation, is currently being evaluated in a randomized phase 2 study in combination with the anti-PD-1 antibody nivolumab in patients with metastatic melanoma. Importantly, the control arm in this study is nevo plus ipilimumab rather than nevomonotherapy, representing the current standard of care based on five-year follow-up from Checkmate 067, which showed a significant increase in overall survival with this combination in melanoma over NEVO monotherapy. BMS 986249 is also being studied in combination with NEVO in three additional advanced settings, hepatocellular carcinoma, castration-resistant prostate cancer, and triple negative breast cancer. BMS 986288, a pro-body version of a non-fucosylated ipilimumab with increased Treg depletion properties, continues to be evaluated in a Phase I study in advanced solid cancers as monotherapy and in combination with NEVA. Switching now to our research and preclinical programs in the field of conditionally activated T-cell bispecific antibodies, we see a major opportunity here to improve the therapeutic window of this modality using our platform, and we're pursuing multiple projects with our partners, Amgen had dispelled. CX904 is a conditionally activated T cell engaging bispecific directed against EGFR on tumor cells and CD3 on T cells, and this is in IND enabling studies. We recently submitted a pre-IND meeting request to the FDA, and we expect written responses to our questions from the regulatory agency in the third quarter of this year. We will continue to discuss the program with our partner, Amgen, and we're working towards the filing of an IND for CX904 in late 2021. Q2 was also highly productive for cytomics in terms of publication of our work in peer-reviewed journals. A total of five manuscripts were recently published covering our work that ranges from phase one investigation of CX2029, as I already mentioned, to multiple publications describing our clinical work with pacmelamab or CX072, our wholly owned conditionally activated antibody against PD-L1. Of particular note, our recent collaborative work with Dr. Elizabeth DeVries of the University Medical Center, Groningen, in the Netherlands, has investigated the biodistribution of pacnilamab in cancer patients using clinical imaging. This study has shed important light on the molecular performance of the probody platform in cancer patients, including the direct demonstration of activation and binding of pacnilamab to primary and metastatic tumors. Another recent publication of particular note is our landmark preclinical study of a probody immuno-oncology agonist in the proceedings of the National Academy of Sciences. As you will recall, we introduced earlier this year our advancement of our conditional activation technology into the cytokine space. This recent PNAS paper takes things even further as the first published application of the Cytomix platform to agonist antibodies in immuno-oncology, emphasizing the versatility of our platform. Specifically, together with our collaborators, we have shown in this publication that an anti-CD137 probody retains post-attach tumor activity with significantly reduced liver toxicity compared to an unmasked antibody when assessed in the same mass model system. This is exactly what our platform is designed to do. The paper also includes extensive characterization of pro-body activation by tumors. Taken together, these publications underscore the immense progress we've made across our pipeline and platform with our first generations of pro-body therapeutics. field that Cytomix has defined and continues to lead, and we continue to innovate on the core platform and across many therapeutic modalities. Let me now hand the call over to Amy for additional detail and updates on our lead clinical programs.
spk03: Thanks, Sean. I'll start with a quick recap of the designs for our Phase 2 studies of CX2029 and Prelazacumab. For CX2029, in collaboration with AbbVie, we continue to enroll patients into the expansion phase of this phase 1-2 study designed to evaluate the CD71-directed conditionally activated ADC in four different cohorts, squamous non-small cell lung cancer, head and neck squamous cell carcinoma, esophageal and gastroesophageal junctional cancers, and diffuse large B cell lymphoma. Each cohort aims to enroll up to 25 efficacy-evaluable patients And we continue to expect initial data from the expansion phase of the study in the fourth quarter of this year. Switching to CX2009, or Praluzacumab-Raptanzi, we are evaluating the CD166-directed conditionally activated EDC as monotherapy in patients with HER2 non-amplified breast cancer, which includes hormone receptor positive, arm A, and triple negative breast cancer, arm B. We are also evaluating the combination with our proprietary anti-PD-L1 therapeutic, Pacmelamab, in patients with triple negative disease in arm C. The goal is to reach 40 efficacy-evaluable patients in each of these arms, and the primary endpoint of this study is overall response rate according to RESIST. Secondary endpoints include duration of response and clinical benefit rate at 24 weeks. the latter being particularly an important metric for the hormone receptor positive subtype as it is a reasonable surrogate to support progression-free survival endpoints in future studies. Enrollment is ongoing. However, our accrual rate for a fourth quarter 2021 initial data readout has been slower than expected due primarily to the widespread effects of the COVID-19 pandemic on site activation and on patient enrollment. The Praluzacumab Phase 2 study is a new trial requiring de novo site activation, and this has proven particularly challenging in the current environment. As such, we now anticipate initial data from this study in 2022. Notwithstanding the COVID-19 challenges, we continue to implement ways to help improve the pace of patient enrollment, including opening additional sites in the U.S., Europe, and Asia, as well as partnering with patient advocacy groups to encourage enrollment from underrepresented populations, given the fact that triple negative breast cancer is more prevalent in minority women. We are excited about the opportunity for paroxetamab in breast cancer, and I would like to take a few moments to look ahead to where this unique drug candidate has the potential to fit into the treatment landscape. Recall that historically, breast cancer has been divided into three major subtypes, and treatments have been developed accordingly. ERPR-positive, which is responsive to hormonal therapies, HER2-amplified, which is responsive to HER2-targeted therapies, and triple-negative breast cancer, named not for what it is, but rather what it is not, and is therefore a heterogeneous grouping. Before turning the call over to Carlos to review our financials, I want to point out that in our Phase II study, effectively, we are evaluating praluzemab and HER2 non-amplified breast cancer. an emerging classification that combines hormone receptor positive with triple negative breast cancer and represents approximately 80% of all breast cancer and includes those that express both low and no levels of HER2 by IHC. It's also important to note that CD166 expression is found across all of these subclassifications of breast cancer and thus, CX2009 represents a significant opportunity.
spk04: Thank you, Amy. With $366 million in cash, cash equivalents and investments as of June 30th, 2021, Phytomics remains well capitalized to support our bold clinical and research agenda that will drive the growth of the company well into 2023. Revenue was $16 million for the second quarter of 2021. relatively flat when compared to the corresponding period in 2020. R&D expenses increased $2 million to $26 million during the three months ended in June 30, 2021, compared to the corresponding period in 2020. The increase was driven mainly by timing of manufacturing and translational science activities. G&A expenses were $9 million for Q2 2021, essentially flat compared to the second quarter of 2020. With that, I'll turn the call back to Sean.
spk08: Thanks, Carlos, and thanks to everyone for joining us today. To briefly recap, SciTech has continued to make broad progress in Q2 across our pipeline and platform. We currently have four novel pro-body assets in Phase II studies across nine cancer types, with readouts starting at the end of this year with CX2029. We also continue to develop our core technology across multiple biologic modalities as we advance new clinical candidates into development. Our recently published work highlights the scope and scale of our R&D efforts as we drive our pipeline forward and invest in our technology for the long term. With that, let's open up the call for questions. I'll turn it back to the operator.
spk05: As a reminder, to ask a question, you'll need to press star one. It's also in keypad. To withdraw a question, please press pound or hash key. Please stand by while we compile the Q&A roster. Our first question comes from the line of Anupam Rama from J.P. Morgan. Your line is now open.
spk11: Hey, guys. Thanks so much for taking the question. For CX2029, can you remind us the size and scope of the data we'll be getting here in 4Q and remind us if this is going to be at a medical meeting or should we be thinking about more of a top-line press release webcast type scenario? Thanks so much.
spk08: Hey, how are you? Good to hear from you. So, we're guiding to initial data from the expansion phase by the end of the year. We haven't pinpointed any particular venue or method through which we would communicate that data. As Amy mentioned, there are four cohorts in this expansion phase, the head and neck, the lung, the esophageal, and the DLPCL. We are anticipating initial data from at least one of these cohorts by the end of this year. We're on track, and as I said, we haven't guided exactly where that would be.
spk11: Thanks for taking our question.
spk05: Our next question comes from the line of Roger Song from Jefferies. Your line is now open.
spk01: Great. Thank you. Very similarly, the question for the DX2009, so what should we expect in the initial readout because I remember last quarter, you say the initial data will from the arm one and B, A and B. And should we also expect to arm A and B as the initial data? Also, you broadly guide to 2022. Can we have some granularity in terms of first half or second half of 2022, which should be expecting the data? Yeah. Hi, Roger.
spk08: Thanks for the question. So, yes, again, just to recap, arm A is hormone receptor positive. Arm B triple negative, they're both monotherapy. Arm C is the combination with our proprietary PD-L1 probiotic Pacmelamab. So the revised guidance remains for arms A and B in 2022. Arm C, and at this point, we're not going to be more specific than that. I think given the evolution of the macro environment and just the uncertainties around COVID, We're going to keep that guidance pretty broad right now. We do have, though, I can say for 2009, we are making progress. We do have more than 20 sites open for the study, so the team has made a lot of progress. We need to make more, and, you know, every day is a new day in the current world. In terms of RMC, the combination with Pacmelamab, you know, we've pretty consistently guided that that would be slower than RMs A and B, given that we're screening for both CD166 and PD-L1. That's going to be a smaller patient population. We'll have to see how that develops. We'll provide additional guidance as time moves on on the timing of RMC.
spk01: Yeah, I understand. Yeah, every day is a new day. So maybe just another question from me is the earlier pipeline program, so something like the cytokine derivative, program, which is very exciting. Just any updates from that.
spk11: Roger, could you repeat which program?
spk01: I didn't quite get it. Yeah, just any updates for your cytokine derivative program and any other kind of earlier program.
spk08: Yeah, you bet. And as I mentioned in my remarks, you know, we're really excited about where we are with the platform. The The work that we've done, much of which we've now published in peer-reviewed form, is demonstrating the utility of the pro-body approach across multiple biologic modalities, now extending in our most recent work to cytokines and into immune agonist antibodies with the PNAS paper on CD137. So, we presented some work earlier this year on interferon-alpha-2b, a really unique approach to masking that cytokine, which I think there's general agreement that there is enormous potential for focusing or harnessing the clinical activity of that particular biology if we can increase the therapeutic window. Our preclinical data supports that we have open therapeutic window. We're moving that asset further into preclinical development. We're still in lead optimization, I would say, at this stage, but certainly moving it forward. And we continue to look at bispecifics and we'll continue to apply the platform to drug conjugates against undruggable targets. So a lot of potential. I also mentioned on the call our EGFR CD3 program, which is really a big idea in bispecifics. We know from work that was previously published by Micromed some years ago that EGFR in a CD3 bispecific form is a very difficult target to drug. We're bringing our masking technology to bear to attempt to open a therapeutic window. And as I mentioned, we're working towards getting that IND on file by the end of this year.
spk01: Got it. Thank you for all the comments. Thank you. You're welcome.
spk05: Our next question comes from the line of Joe Catanzaro from Piper Sandler. Your line is now open.
spk09: Great. Thanks so much for taking my questions here. So, Amy, you had mentioned that for CX 2009, it was a new study that required new site initiations So it sounds like, in contrast, 2029, the phase two cohorts just rolled over from the phase one and didn't require new site initiations. Can you confirm that, and is that the case for all expansion cohorts, or did some tumor types, i.e. DLBCL, require some new sites to open up and enroll patients? Thanks.
spk03: Sure. Thanks, Joe, for the question. Yeah, to confirm, the 2029 study, was designed as a phase 1-2 study with expansion continuing at sites that were open, which allowed us to continue enrollment. As you point out, there are interesting novel cohorts, and we did look at activating new sites to help boost enrollment, but the continuation of enrollment was allowed primarily due to the continuation of the study at the already open activated sites.
spk09: Okay, got it. That's helpful. And then I think you guys had previously guided towards data potentially by the end of the year from both the lung cancer and head and neck, but it sounds like maybe you've backtracked a little, if I heard correctly, that we could expect at least one cohort's worth of data of the four.
spk08: Yeah, I wouldn't describe that so much as a backtrack. I think we're generally on track with prior guidance.
spk09: Okay, got it. That's helpful. Thanks for taking my question. You bet.
spk05: Our next question comes from the line of Boris Peeker from Cohen. Your line is now open.
spk02: Hi, thanks. This is Cynthia on for Boris. For CX2009, are you still seeing around 50% of patients, triple negative patients expressing CD166 at a high level And then just thinking through for arm C, are you getting a sense of how many triple negative patients express both CD166 and PD-L1?
spk08: Hi. Yeah, great question. We continue to evaluate target expression across these arms in the phase two study. Nothing to really comment on right now, but that continues to be an important component of the study as we continue to learn And we'll continue to learn about the relationship between CD166 expression and response and the CD166 expression across these different patient populations. So it continues to be very much a work in progress.
spk02: All right, great. Thank you.
spk05: Our next question comes from the line of Ed Sergerow from Guggenheim. Your line is now open.
spk10: Thank you. Great. Thanks for taking the question. This is Paul on for EDSER. Just one from us for your EPCAM program, the CX2043. Have the supply chain issues you sort of discussed last quarter been resolved? And is there any update to your IND plan for this program? Thanks.
spk08: Yeah, thanks for the question. And I actually neglected to mention EPCAM while I was doing my recap of our early pipeline earlier on in response to Roger's question. Yeah, so we've made progress there. And just to recap, the challenge that we ran into was relating to the DM21 payload, which is a next-gen Matanzine. We've made a lot of progress there. We're still looking at what that timeline is going to be, so there's no formally updated guidance, but we are making progress with the program and with Epcam generally as a target, which we continue to be highly interested in.
spk10: Great, thanks so much.
spk05: Our next question comes from the line of Peter Lawson from Barclays. Your line is now open.
spk07: Thanks, Sean. Just on, I guess the CD71 data, I'm just trying to piece it together. So I think last time you got, you were suggesting that the head, neck, and the lung would be at the end of the year. Is that still the case? And then DRBCL kind of next year? Is that the right order, and do we get kind of data sets year-end for head, neck, and lung?
spk08: Yeah, so the, again, those four cohorts of head, neck, lung, esophageal, and DLBCL, the first two were obviously selected based on data that we saw in the phase one dose escalation activity that we saw in phase one, and obvious choices for phase two expansions. And I would say, yeah, generally on track for those two cohorts to present updates by the end of the year, and with the others following thereafter.
spk07: And the venue for that would be more of a press release than a conference.
spk08: We haven't disclosed the strategy at this point. Peter will provide further information as we go further through the year.
spk07: And the breast cancer delays, like triple negative and HR positive HER2 negative, was that predominantly driven by these kind of new site inactivations, or was there anything else that we should be thinking about?
spk08: Yeah, it's really a COVID thing. And as I said, we've got a pretty decent number of sites open. A lot of those have come on fairly recently. The team is really working all hours to get this, to bring this study in. We're excited about this asset. We want to see this data as much as anybody else, but it's a tough operating environment right now to get new sites initiated. I think you'll be hearing that from others. And that's, you know, we're, We're certainly seeing a lot of enthusiasm from our investigators. I'll take you back to our analyst event earlier this year where you heard Sarah Kalani talk about the potential of Pranazatamab, Raptanzine. And so, yeah, this is an operational challenge, and we've just got to keep powering through.
spk07: Gotcha. Okay. Thanks for the update.
spk08: You're welcome.
spk05: At this time, I would like to hand the conference back over to Chow Chang for his closing remarks.
spk06: So 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.
spk05: Ladies and gentlemen, this concludes today's conference call. Thank you for participating. You may now disconnect. And have a great day.
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