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spk06: Good afternoon and welcome to the Curtis Thomas article second quarter 2022 earnings conference call. All participants will be in a listen-only mode. Should you need assistance, please sign up conference specialist by pressing the star key followed by zero. After today's presentation, there will be an opportunity to ask questions. To ask a question, you may press the star then one on a touch-tone phone. To withdraw your question, please press the star then two. Please note this event is being recorded. I would now like to turn the conference over to Aaron Begolin. Please go ahead.
spk01: Thank you, operator, and good afternoon, everyone. Thanks for joining us for the Corvus Medical's second quarter 2022 update and financial results conference call. On the call to discuss the results of the business updates are Richard Miller, Chief Executive Officer, Leif Leif, Chief Financial Officer, My name is James Rosenbaum, Senior Vice President of Research. The executive team will open the call with some prepared remarks followed by a question and answer period. I would like to remind everyone that comments made by management today and answers to questions will include forward-looking statements. Forward-looking statements are based on estimates and assumptions as of today, subject to risks and uncertainties that may cause actual results to differ. from those expressed or implied by those statements, including the risks and uncertainties described in this quarterly report on Form 10-Q, which was filed today with the SEC and other filings the company makes with the SEC from time to time. The company undertakes no obligation to publicly update or revise any forward-looking statements except as required by law. With that, I'd like to turn the call over to Leif Leith.
spk02: Thank you, Aaron. I'll begin with a quick overview of our second quarter 2022 financials and then turn the call over to Richard for a business update. At June 30th, 2022, Corvus had cash, cash equivalents, and marketable securities totaling $56.7 million as compared to $69.5 million at December 31st, 2021. Importantly, as Richard will discuss, we have prioritized our clinical stage pipeline plans and extended our cash runway into early 2024. Research and development expenses in the second quarter 2022 totaled $4.9 million compared to $9.1 million for the same period in 2021. As you can see, we continue to prudently manage our cash burn rate while advancing our portfolio of product candidates. We are able to achieve this by the judicious utilization of experienced personnel, leveraging external resources, and establishing collaborations that help support development of our products. Examples of these collaborations are Angel Pharmaceuticals, our partner in China, now involved in clinical trials with our ITK inhibitor, and the Kidney Cancer Consortium, who will be conducting our frontline RCC trial with Sephora Denon. The NETMOS for the second quarter of 2022 was $8.4 million compared to a net loss of $11.8 million for the same period in 2021. Total stock compensation expense for the second quarter of 2022 was $0.7 million compared to $1.2 million for the same period in 2021. I will now turn the call over to Richard, who will elaborate on our strategy and plans.
spk04: Thank you, Leif, and good afternoon, everyone. Thank you for joining us today for our second quarter 2022 business update. In the first half of 2022, we made considerable progress with our three clinical stage programs, which are all well positioned to move into mid-stage trials. We are excited about their potential to bring new therapeutic approaches to a range of diseases by modulating activity in the tumor immunity axis. As we continue to advance our pipeline, we remain mindful of the current environment in the biotech industry and are adapting accordingly. Portfolio prioritization is an ongoing part of our development process. And in order to extend our cash runway, we are focusing on the development of our programs that provide the best opportunity to deliver value by generating meaningful near-term clinical data. Based on recent clinical data and preclinical research, we have made the strategic decision to focus greater resources on our CPI-818 ITK inhibitor program. We feel that this drug may have diverse opportunities across oncology, autoimmunity, and allergic diseases. We also plan to advance cifiradmin into a Phase II frontline renal cell cancer trial in partnership with the Kidney Cancer Consortium. We will pause on initiating the previously planned randomized blinded phase two trial in lung cancer for mupidolamab given the timeline to data and the increasingly crowded CD73 landscape. To be clear, we still believe mupidolamab has great potential and look forward to advancing its development in the future. We continue to believe that mupidolamab's activation of B cells and immunomodulatory properties make it distinct among competitors. I will now provide an update on each of these programs, starting with CPI818, our ITK inhibitor. In May, we hosted an R&D symposium in New York that provided a thorough background on the clinical and preclinical data that has us so excited about 818's potential to treat T-cell lymphomas, along with a variety of indications across autoimmunity and allergy. A replay and slides from this event are available on our website for anyone that has not had the opportunity to view it. Here are a few of the key points and updates from the symposium. CPI-818 is a covalent ITK inhibitor and binds to ITK similar to the way ibrutinib binds to BTK. It is well known that ITK is involved in T cell receptor signaling, homologous to BTK's involvement in B cell receptor signaling. Less well appreciated, but clearly shown by others in preclinical animal models, is that ITK has a crucial role in T cell differentiation. In our ongoing phase one clinical trial in T cell lymphoma, we have been able to demonstrate that ITK also plays a vital role in differentiation of normal human T cells. These findings were anticipated by the Corvus team and indeed were one of our motivating factors for pursuing this drug. The findings that we can modulate T cell differentiation on one hand and at higher doses block T cell receptor signaling now provide us with an opportunity to develop a very important new medicine. Starting with lymphomas provided us an opportunity to evaluate a myriad of immunologic properties. Our T-cell lymphoma trial gives us the information and supports the rationale to expand into other immune diseases. With this strategy, we see many similarities to development of other immunologically active agents, such as rituxan and ibrutinib, which also started in lymphoma and then expanded into other diseases. As you may know, anti-CD20 antibodies like rituxan and BTK inhibitors are now widely used in the treatment of B-cell lymphomas, and members of the Corvus team played crucial roles in the discovery and development of these agents. Rituxan is approved for several autoimmune diseases, and BTK inhibitors are in various phases of testing for these diseases as well. Data from our global phase 1 1B trial in T cell lymphomas has led to the identification of 200 milligrams twice a day orally as the optimal dose of CPI 818 for modulation of T cell differentiation. And we are expanding enrollment in that dose court of the trial. The study is ongoing. together with our partner in China, Angel Pharmaceuticals. We have submitted an abstract to present an update on this data at the ASH meeting in December, if accepted. As reported in our press release today, 12 patients have been enrolled and eight are available for response. There has been one complete response lasting 25 months, one nodal complete response lasting 16 months, one partial response ongoing at two months follow-up. Five patients had stable disease. Two of these have been on therapy for approximately 12 weeks and continue on study. Two additional patients on treatment have not yet had their disease monitoring assessments. An additional patient in the 600 milligram cohort also had a partial response. I should point out that the published overall survival of first relapse T cell lymphoma is reported to be a median of 5.6 months, and progression-free survival is less than three months. Obviously, this is a very serious disease. The median number of prior therapies in our patients is four. Of significant importance are the correlative lab studies on the blood and on the tumors of responding patients, which showed, one, evidence for Th1 skewing, two, an increase in T-effector cells in blood and tumor, and three, an increase in activation of T cells in the blood and tumor. These findings are the hallmark of effects on T helper cell differentiation. Very simply, CPI-818 blocks so-called Th2 cells, leading to what is known as Th1 skewing. Th2 cells are the cells often involved in autoimmunity, fibrosis, and allergy. Th1 are key to production of cytotoxic T cells, which are involved in the killing of cancer cells and virally infected cells. These findings support a novel mechanism of action for the eradication of malignant T cells. We believe we may be inducing a normal host anti-tumor or anti-lymphoma response. It is possible that this approach could be utilized for other tumors as well. If this is the case, then the strategy of T cell modulation with 818 could become a new paradigm in tumor immunotherapy for other cancers, including solid tumors. Preclinical studies and animal models are underway to test this possibility. In addition, we've made other observations in our ongoing phase one study that are pertinent for allergy. It is known that Th2 cells are the culprits in diseases like asthma, atopic dermatitis, fibrotic diseases such as idiopathic pulmonary fibrosis, and others. A key biomarker of Th2 hyperactivity is eosinophilia. High eosinophil counts in the blood are due to the secretion of various cytokines by Th2 cells. Eosinophils are white blood cells that play a role in allergic and autoimmune diseases and they are often elevated in patients with T-cell lymphomas. In our ongoing lymphoma study, we have seen 818 causes reductions in circulating eosinophils in several patients with high baseline pretreatment counts. These findings motivate us to consider use of 818 in allergic diseases. We also are generating encouraging preclinical data with 818 in autoimmunity. Some of this has been previously presented at ASH in 2020 and ASH in 2021. In order to expand and enhance our ability to advance these opportunities, we hired Dr. James Rosenbaum, our new senior vice president of research in late July. Jim is a board certified rheumatologist and preeminent immunologist with deep clinical and research experience specific to inflammation, autoimmunity, arthritic diseases, and the role of the microbiome in immunity. He comes to us from Oregon Health and Sciences University, where he served as professor of medicine and cell biology and chair of the Division of Arthritis and Rheumatic Diseases. Jim's initial focus will be on the development of CPI 818. I will pass the call to him now for a brief introduction, and he will be joining us in the Q&A portion of the call. Jim?
spk03: Thank you, Richard, and good afternoon, everyone. I am excited to be joining you here today, and I look forward to meeting many of you virtually and in person in the coming months. As Richard noted, my career is focused on the study and treatment of inflammation and autoimmune disorders. I became very excited about Corvus after learning about the immunologic properties of CPI-818 and looking at the early findings in lymphoma patients. Although the ITK target has been known for some time, Corvus is the first group to determine that this target could have valuable therapeutic possibilities in a range of diseases. While I am still early in my time at Corvus, there are several key reasons why I am optimistic about 818 and our broader pipeline. First, CPI-818 is unique. I am not aware of any other ITK inhibitors currently in clinical development. A key characteristic of CPI-818 is its exquisite specificity for ITK, which turns out to be crucial for affecting differentiation of T cells. CPI-818 clinical and preclinical data are encouraging and speak to its broad potential. We have the opportunity to help a significant number of patients with T-cell lymphomas, immune-mediated diseases, or allergies, and also to enhance understanding of some fundamental immunologic principles. Third, Corvus is a leader in research and development related to the adenosine axis. Our programs, CIFO and MUPA, have unique properties relative to other programs in development and are phase two ready. Together, the Corvus portfolio of product candidates creates exciting new opportunities to potentially impact several important areas of medicine. And with that, I will turn it back to Richard.
spk04: Thank you, Jim. We look forward to advancing CPI-818 and our other products under your leadership. We believe we are positioned to initiate clinical trials in autoimmune and or allergic diseases over the next 6 to 12 months. Moving on to cifiradinant, our adenosine 2A receptor antagonist, we are progressing with our phase two trial with the Kidney Cancer Clinical Trial Consortium in frontline renal cell cancer focused on the triplet combination of SIFO plus ipilimumab and nivolumab. This trial is based on our publication in 2018 showing synergy of sifiradonid with anti-CTLA-4 antibody in preclinical tumor models. The trial, which will enroll up to 60 patients, is anticipated to be initiated in the third quarter of this year. The primary endpoints will be deep responses. Deep responses are CRs and PRs with greater than 50% reduction in tumor volume, reflecting our goal to raise the plateau on progression-free survival and survival by adding cifir adenine. The Kidney Cancer Consortium is led by MD Anderson and includes several leading centers such as Vanderbilt, Beth Israel Boston, Cleveland Clinic, UT Southwestern, and others. As a reminder, this is an open-label, single-arm trial, so we anticipate that we will get a good feel for efficacy early in the trial. For mupidolamab, our B-cell activating anti-CD73, while we are pausing initiation of our Phase II trial, we believe it is differentiated in the CD73 landscape as it binds to a unique epitope on the CD73 protein, which on B cells results in their activation and differentiation into antibody-producing plasma cells and into memory B cells. This property is not dependent on adenosine. I emphasize this point because we think that the immunomodulatory properties provide a unique mechanism of action in immunotherapy. Our partner, Angel Pharmaceuticals, will continue developing mupidolumab in China with a planned phase one trial exploring monotherapy and combination with pembrolizumab in patients with advanced lung and head and neck cancer. The IND for this trial was recently accepted by the CDE in China. In closing, we believe Corvus is well positioned with several potential catalysts for our programs in the next 12 months, combined with an extended cash runway that now runs into 2024. Key upcoming milestones include expanding enrollment of peripheral T-cell lymphoma patients with additional phase one data before the end of the year with CPI-818. As a reminder, this study will include angel pharmaceuticals who will be responsible for the portion of the study in China. Second, CPI-818 development in autoimmune and allergy is ongoing with a goal of initiating clinical trials early next year, early 2023. Third, starting the CIF-ORIDIN phase two trial for frontline renal cell cancer in partnership with the Kidner Cancer Consortium in the third quarter, with the potential for a read on clinical activity relatively early in enrollment since it is an open-label study. We look forward to providing updates on these key initiatives in the coming quarters. I will now turn the call over to the operator for questions and answers. Operator?
spk06: Thank you. We will now begin the question-and-answer session. To ask a question, you may press star then 1 on your touch-down phone. If you're using a speakerphone, please pick up your handset before pressing the key. If at any time your question has been addressed and you would like to withdraw your question, please press the star then G. At this time, we will pause momentarily to assemble our roster. Our first question comes from Lee Wozzeck with Kenner Fitzgerald. Please go ahead.
spk05: Hi, everyone. This is Rosemary. I'm for Lee. Thanks for taking my question. I just have a couple. So first, for 818, I'm just wondering if you have any ideas about the pathway to approval and the approximate timeline for that.
spk04: Okay. Do you want to give me your second question as well?
spk05: Sure. So the second question regarding lupidolumab. Would you be able to discuss potential BD opportunities given that the future trials in lung cancer are going to be quite expensive?
spk04: Okay. First, the pathway to approval for 818 in lymphoma. So as we're currently studying 818 in patients who've had multiple recurrences, our goal of the ongoing current trial is to confirm the responses that we've seen. Then the next step would be a phase two trial, again in advanced recurrent patients. As I mentioned, once you fail once, your median survival is less than six months. So we think that as a monotherapy, there's a potential pathway to approval with a single arm study. Now concomitant with that, I would also, and given the safety that we've seen with 818, I would also want to move that frontline probably in combination with a standard chemotherapy like CHOP or CHOEP. That would need to be a randomized trial, and in a trial like that, you would need to have PFS as an endpoint. So I think a single-arm trial with monotherapy in advanced disease followed or concomitantly performing a randomized trial in early-line peripheral T-cell lymphoma. There's not good treatments for this disease, as you know. There's some approved agents, but they're not very good. And we believe that, you know, this represents a very novel mechanism of action that's more active than some of the other agents have shown in early development. Now, one other thing just to add on that. One of the things, and I tried to emphasize this in our comments, was that when we're treating T-cell lymphoma patients, we're also studying their normal T cells and B cells and the rest of their immune function. And it's almost as if we're getting multiple kinds of lines of information out of these T cell lymphoma trials that we think inform us for autoimmune trials. Now, your question on mupidolamab. The lung cancer space has become crowded, and many people are waiting for additional data with TIGIT combinations with anti-PD-1s. We're also waiting to see how some of that shakes out. We have a protocol ready to go. It's a protocol that I've described before, which is chemo and PEMBRO plus or minus MUPA. We know what trial we need to do. We're just waiting to see how some of that shakes out. We think, given that it's a blinded randomized phase two trial, one of the reasons that we've decided to pause on that, as I mentioned, was that we're not going to be able to look at data for that for some period of time, for 12 or 18 months, and whereas investing in our other programs gives us data on an ongoing basis very quickly and enables us to build value in this rather tough environment. So MUPA is a unique anti-CD73, and we're looking forward to getting that back in the clinic as soon as markets improve.
spk05: Okay. Thank you.
spk06: Our next question comes from Mara Goldstein with Mizzou. Please go ahead.
spk08: Hi. Hi. This is support for Mara. I have a question on 818 in autoimmune disease. I know you showed the data, the preclinical data in GVHD before. I'm just curious if that's the indication that makes the most sense, you know, with regard to the immunologic properties of 818. So are there any other autoimmune disease that you think, you know, would make more sense? And then the second question is, can you speak to the potential differences in the dosing of 818 in TCL versus autoimmune diseases. Thank you.
spk04: All right. Jim, Dr. Rosenbaum, maybe I'll let you take the first part of that question. Sure.
spk03: Well, in addition to the data on acute GVHD, we have reported data on the MRL LPR mouse, which has similarities to lupus. We've reported data on a T-cell mediated colitis model and data on a mouse psoriasis model. So those are diseases of interest as well as some of the diseases that Dr. Miller mentioned, atopic dermatitis, pulmonary fibrosis, and asthma. And I think we're sorting through those data to decide what's going to be the initial clinical target.
spk04: Okay. If I can just add to that, specifically answer your question, graft versus host disease would not be my initial target. Because we think that the diseases that Dr. Rosenbaum just mentioned, atopic dermatitis, asthma, inflammatory bowel disease, fibrotic diseases, are huge opportunities. And here we have an oral agent that has a novel mechanism of action. that has been shown to be relatively safe at much higher doses than we would use for autoimmune disease, which segues into your second question, which was on dosing. The dosing for autoimmune diseases is likely to be lower, and that's because what we really want to do, really any autoimmune or allergic disease that involves TH2 cells, so-called TH2 cells, and you can look that up. There are a lot of those. would be a potential target for this therapy. But I think that the 200 milligram dose we're using in peripheral T cell lymphoma now is around the ballpark that we would be using for autoimmune disease. Perhaps we could go a little bit lower.
spk00: Got it. Thank you.
spk06: Again, if you have a question, please press star then one. Our next question comes from Sean Lee with HC Wainwright. Please go ahead.
spk07: Good afternoon, guys. Thanks for taking my questions. I have two questions in particular. First, for the 818, with the upcoming updated hash, Could you provide us a little overview of what kind of data we can expect in terms of patient numbers, endpoint, biomarkers, and is it only going to be just from the 200 milligram cohort, or are we going to get an update from the other dose cohorts as well?
spk04: Okay. We will give an update on all the dose cohorts. We are actually looking at some doses above 200, just to round out our pharmacokinetics and get a better feel for things. So what we expect to show at ASH would be data on, I would say, 40 to 50 patients, efficacy data, safety data, any kind of immunologic data we have from blood work and biopsy data. And that will include, the abstract's already been sent to ASH. Of course, it needs to be accepted. And it includes work both from Angel in China as well as the Corvus part of the study.
spk07: Great. Thanks for that. And for the MUPA, are we going to get any more updates from the pembrolizumab combo study or is all that paused at the moment?
spk04: Well, we still have some patients on follow-up from our phase one study. And ANGEL is very shortly gonna be starting their phase one study in lung cancer and head and neck, the same tumors that we were going after. And thank you for pointing that out. We're pausing it here at Corvus, but the study is going forward with ANGEL in China, and we're still gonna get information out of that. Our big reason for pausing was really to focus our resources on the other two programs, which we think can provide clinical data faster and build some value. So I don't have a timeline for new updates on MUPA, but we're still enrolling and following patients together with ANGEL.
spk07: I see. That was very helpful.
spk04: Let me be clear. We're not enrolling patients at Corvus. We're following patients that have been on our study, and Angel will be enrolling patients shortly.
spk07: Yep. Got it. Got it. Thanks.
spk06: All right. Thank you. This concludes our question and answer session. I would like to turn the conference back over to Richard Miller for any closing remarks. Please go ahead.
spk04: Thank you, Operator. Thank you, everyone, for joining our conference call today. It's been a pleasure to update everyone on what's going on at Corvus, and we look forward to giving further updates on our quarterly conference calls. Thank you, and goodbye.
spk06: The conference has now concluded. Thank you for attending today's presentation. You may now disconnect.
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