Q4 2023 Corvus Pharmaceuticals Inc Earnings Call
Participants
Zach Kubow; IR; Real Chemistry
Ian Clark; CFO; Corvus Pharmaceuticals Inc
Richard Miller; Co-Founder, President & CEO; Corvus Pharmaceuticals Inc
Jeff Arcara; Chief Business Officer; Corvus Pharmaceuticals Inc
Jeff Jones; Analyst; Oppenheimer & Co. Inc
Leon Chang; Analyst; Jefferies LLC
Rosemary Li; Analyst; Cantor Fitzgerald & Co
Presentation
Operator
Good afternoon, everyone. Thank you for standing by, and welcome to the Corvus Pharmaceuticals Fourth Quarter and Full Year 2023 business update and financial results conference call. (Operator Instructions) It is now my pleasure to turn the call over to Zack Kubow of Real Chemistry. Please go ahead.
Zach Kubow
Thank you, operator, and good afternoon, everyone. Thank you for joining us for the Corus Pharmaceuticals Fourth Quarter and Full Year 2020 from a business update and financial results conference call. On the call to discuss the results and business updates are Richard Miller, Chief Executive Officer; Leiv Lea, Chief Financial Officer; Jeffrey Arcara, Chief Business Officer; and Ben Jones, Senior Vice President of Regulatory and pharmaceutical sciences.
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 materially from those expressed or implied by those statements, including the risks and uncertainties described in our annual report on Form 10-K, which was filed today with the SEC. Other filings the company makes with the SEC from time to time. Company undertakes no obligation to publicly update or revise any forward-looking statements, except as required by law.
I'd like to turn the call over to Leiv.
Ian Clark
Thank you, Zach. I will begin with a quick overview of our fourth quarter and full year 2023 financials and then turn the call over to Richard for a business update. Research and development expenses in the fourth quarter of 2023 totaled $4 million compared to $4.1 million for the same period in 2022. R and D expenses for the full year 2023 totaled $16.5 million compared to $24.5 million for the full year 2022.
The net loss for the fourth quarter of 2023 was $6.7 million, including a $1.4 million noncash loss related to Angel Pharmaceuticals, our partner in China. This compares to a net loss of $9.8 million for the same period in 2022, which included a $4.6 million noncash loss related to Angel pharmaceuticals.
The net loss for the full year 2023 was $27 million, including a $5.3 million noncash loss related to annual compared to a net loss of $41.3 million, including a $10 million noncash loss related to Angel for the full year 2022.
Total stock compensation expense for the fourth quarter and full year 2023 was $0.6 million and $2.1 million, respectively. Compared to $0.6 million and $2.7 million in same periods in 2022. As of December 31st, 2023 quarters had cash, cash equivalents and marketable securities totaled totaling $27.1 million as compared to $42.3 billion at December 31, 2022.
I I'll now turn the call over to Richard, who will discuss our clinical progress and elaborate on our strategy and plans.
Richard Miller
Thank you, Leiv, and good afternoon, everyone. Thank you for joining us today for our business update call, Corvus has become a pioneer in the research and development of ITK. inhibition as a new therapeutic modality to benefit patients with a diverse range of diseases. We have demonstrated that selective inhibition of this target leads to significant biologic effects that could lead to new treatments for cancer and immune diseases.
In 2024, we are focused on two key value drivers to further confirm and advance this opportunity. First, begin patient enrollment in a registrational Phase 3 trial of so-called nib for patients with relapsed PTCL or peripheral T-cell lymphomas. An indication with no fully FDA approved therapies and significant unmet need.
And second, begin patient enrollment in a placebo-controlled Phase 1 trial of Circle at nib for patients with moderate to severe atopic dermatitis, which is expected to generate the first clinical data for ITK. inhibition for an immune disease before the end of the year, we believe Corning is positioned to build value in the near term with significant upcoming clinical milestones for so-called mid in oncology and immune diseases, further strengthening our ongoing business development, which is concentrated on partnering opportunities for ITK inhibition.
Recently published data demonstrated the potential role of ITK in a broad range of indications, and we have expanded our capabilities and approach to business development with the appointment of Jeff Arcara as Chief Business Officer. Jeff will be presenting his views and strategy in a moment.
I will now provide further details on our two priorities for the year and our other programs, starting the circle at nib for PTCL., we plan to begin patient enrollment in our so-called net registrational Phase 3 clinical trial in relapsed PTCL in the third quarter of 2024. The data from our Phase 1 trial continues to evolve with longer follow-up of treated patients in the most recent data cutoff from January 2024.
We found that a patient with previously reported partial response of approximately 80% target lesion reduction after nine weeks of therapy subsequently converted to a complete response at 18 weeks due to continued tumor response. This patient who remains on therapy had relapsed extra nodal NK. T cell lymphoma involving the nasal bearings and represents the fourth complete response at 21 Phase 3 eligible patients in the trial.
The objective response rate or ORR for the Phase 3 eligible patients in the Phase 1 trial remains at 7 out of 21 patients with four CRs and three PRs or 33%, although not studied head-to-head, the ORR complete response rate, disease control rate, progression-free survival and overall survival for this group compares favorably to the results seen with Belinostat for proper track, say, which are the standard chemotherapies for PTCL and that we will be comparing against in a Phase 3 trial.
These agents received accelerated approval in the United States, but no definitive trial has been conducted for either the median PFS progression-free survival for our patients. And the primary endpoint for our Phase 3 trial remains at 6.2 months, which is substantially better than reported for the standard agents.
Regarding our interactions with FDA, we reached alignment on the final study protocol. And in February, they granted so-called litany of orphan drug designation for the treatment of T-cell lymphoma. Since this is an important milestone that reinforces the unmet need for new therapies for these patients, given the existing drugs provides limited efficacy and are associated with significant toxicity.
In fact, current NCCN guidelines for relapsed refractory PTCL recommend that patients enter an experimental clinical trial as the preferred treatment for second-line therapy. We are already working with or are in advanced discussions with a number of leading centers in the United States and Canada. We anticipate about 40 centers will participate in the trial the vast majority will be in the US.
Our second priority is circle at mid for atopic dermatitis, the first immune disease indication we are exploring our plans to move into a clinical trial are supported by our preclinical work, including using so-called witness to successfully treat spontaneous canine atopic dermatitis. We are on track to initiate a Phase 1 trial in April, we plan to enroll 64 patients with moderate to severe atopic dermatitis that has progressed on at least one prior therapy.
The study will be randomized, placebo-controlled and blinded to patients and the treating physicians. There will be four sequentially enrolled cohorts of 16 patients with patients in each cohort being randomized 3 to one two different dosing regimens of so-called nib or placebo administered for 28 days. The primary endpoint is safety and tolerability and efficacy will be measured using Investigator Global Assessment and that clinically validated measurement of improvement in Eczema Area and Severity Index, also known as EZEEASI.
It should be noted that while the atopic dermatitis trial is double-blind, patient and doctor are blinded, but the company is not blinded. We plan to evaluate the data in an ongoing manner as successive cohorts of patients complete enrollment based on the anticipated enrollment and follow-up time lines. We believe data from the initial cohorts will be available before the end of 2024.
With study completion in early 2025. We are planning to conduct a solid tumor trial in relapsed renal cell cancer, but are prioritized the initiation of the TTCL and A topic dermatitis trials. Our plans to move into a clinical trial are supported by our preclinical work, an independent academic confirmation led by a team from Erasmus University in Rotterdam. The trial was planned to be conducted in partnership with investigators at the Kidney Cancer Research Consortium.
The clinical and preclinical results we have seen with Circle at nib have motivated us to search for additional analogs of ITK inhibitors. In February, we presented data at the Keystone Symposia on systemic autoimmune and auto inflammatory diseases that included the first description of our next-generation ITK inhibitors, which are designed to deliver precise T cell modulation that is optimized for specific immunology indications.
Given the broad potential of ITK inhibition in inflammatory and immune mediated diseases. We seek to partner with biotech or pharma companies that have established development and commercialization capabilities that match with the various opportunities in order to accelerate our business development activities in February, we appointed Jeff Arcara as Chief Business Officer.
He joins Corvus with more than 30 years of commercial experience in the biopharmaceutical industry, including broad functional experience across commercial development, corporate development, product licensing and partnering and corporate strategy.
I will now pass the call to Jeff to come on to comment briefly on our business development initiatives. Jeff?
Jeff Arcara
Yes, thank you, Richard, and good afternoon, everyone. I am very excited to join the chorus team and to advance the development of a very promising pipeline in cancer core, which is focusing in areas of high unmet need with a novel target and with significant commercial potential.
The opportunity to join Covance at this time was very appealing with a number of potential milestones and key inflection points for the company over the next 6 to 12 months, including the start of our Phase 3 trials of malignant for relapsed PTCL, which is addressing an indication with significant unmet need and provides the opportunity to bring an important new treatment option to patients and to create value for Corvus.
From the commercial perspective, if approved, it will be the only fully FDA approved treatment for relapsed PTCL to give a sense for the magnitude of the opportunity to consider these factors.
PTCL has a very high unmet need with a very low survival rate of under 20% at five years. So there are the desperate need for new and effective therapies for It is estimated that there are 70,000 cases of PTCL globally with current pricing for treatments in the US ranging from 200,000 up to 600,000 per year. So call it and it represents a near term commercial opportunity with our planned Phase 3 trial protocol intended to enroll 150 patients.
So market for drugs to treat hematologic malignancies is large at approximately 55 billion and is projected to grow to $90 billion by 2028. For purposes of benchmarking, global sales of etceteras and anti CD. 30 drug conjugate were 1.6 billion in 2023 with estimated sales of approximately $558 million in patients with non-Hodgkin's lymphomas, primarily in patients with anaplastic T cell lymphoma, a subset of PTCL accounting for about 15% to 20% of cases.
Together, these factors make the PTCL opportunity substantial for a novel effective treatment, as is seen with other disease modifying therapies in the hematology space more broadly, we view PTCL as an entry point with numerous potential ways to expand the opportunity and help more patients with solid tumors and immune diseases.
Given all this, we believe self with nib and our next generation ITT inhibitors can be an attractive opportunity for partners given the unique mechanism of action, human safety data with filgotinib from our Phase 1 lymphoma trial, the large and diverse market opportunities in oncology and immunology, and our strong intellectual property position with issued composition of matter patents for so-called Lebanon extending out to November 2037, not including likely extensions.
With that, our preferred partnering strategy is to find partners with development and commercialization expertise in immune disease as well as to seek regional partnerships in oncology, we have seen increasing momentum in partnering interest since the announcement of our Phase 3 registration trial in the third quarter of 2023 and recent publications on the activity of so-called nib in preclinical models of cancer and immune diseases.
I will now turn the call back to Richard.
Richard Miller
Thank you, Jeff. Turning to our partner lead programs. The Kidney Cancer Research Consortium is currently enrolling patients in a Phase 2 portion of the Phase Ib two clinical trial evaluating ciforadenant, our adenosine A2A receptor inhibitor as a potential first-line therapy for metastatic renal cell cancer in combination with ipilimumab and nivolumab clinical trials expected to enroll up to 60 patients.
And there are currently about 25 patients enrolled based on current timelines, we anticipate initial interim data in the first half of 2024. Encouragingly, as we enroll more patients, we continue to see that the deep response rate exceeds our 32% benchmark based on 14 evaluable patients that have received at least one follow-up assessments, up from eight evaluable patients at our Q3 call.
Recall deep response rate is complete response plus plus partial responses that exceed 50% tumor volume reduction. This endpoint has been shown by others to predict prolong progression-free survival, and it is 32% with ipilimumab and nivolumab for our anti CD73 antibody loop adalimumab, our partner, Eagle Pharmaceuticals, is continuing to enroll patients in a Phase 1a, 1b clinical trial in China with Mubadala mAb alone and together with pembrolizumab in patients with non-small cell lung cancer and head and neck squamous cell cancers.
Summarizing the outlook for 2024, our current cash allows us to achieve near term milestones, including starting our registrational Phase 3 clinical trial of so-called nib in PTCL, generating interim data from early cohorts of the so-called mid-Phase 1 atopic dermatitis clinical trial and reporting interim data with ciforadenant in renal cell cancer in the first half of 2024.
Our intent is to leverage these near-term milestones and achievements as we seek additional funding and partnerships for ITK inhibitors in immunology and oncology, as well as our other novel programs, including the A2A receptor antagonist ciforadenant. We look forward to providing updates on our programs in the coming quarters. I will now turn the call over to the operator for a question-and-answer period. Operator?
Question and Answer Session
Operator
Thank you. Will now conduct our question-and-answer session. (Operator Instructions)
Graig Suvannavejh with Mizuho Securities.
Hi, this is Jerry on for Greg is taking our questions on nearly two from us initially to start off with all the Phase 3 trial initiation Can you kind of speak to what's kind of gating the start of that trial and on, have there been any adjustments to the protocol since I do have a follow-up?
Richard Miller
There's been no changes or adjustments to the protocol. We've been in complete agreement with FDA on the design statistics and other parameters of the trial. Nothing's changed in that regard. Our Phase 1 data continues to improve as we have longer follow-up on where in the process now of finalizing contracts with the various centers and there's really no gating items other than the usual administrative things.
Got it. That's super helpful. And then a question for you, Jeff, can you just speak to a range of pricing and PTCL? Can you kind of speak a little more on to, I guess how corporates are thinking about where you fall in that range or less a range of US steel pricing?
Jeff Arcara
Yeah. And I guess in terms of pricing. Obviously, we look at analogs and what the current market is charging in terms of these areas. I think you take into account the size of the patient population that you're going after. But more importantly, the pricing is really going to be dictated on the size of the unmet medical need, which we know is very large in PTCL as well as you know, the product profile that we present, so the safety and efficacy data that we have.
So I think, you know, obviously, we're looking at analogs at this point in time, but ultimately, the final price will be set once we get the final data and we do some testing with payers on the value proposition.
Got it. Thanks for taking our questions and congrats on the quarter.
Operator
Jeff Jones, Oppenheimer.
Jeff Jones
Hi, guys, and thanks for taking the question on. I guess two from me. Can you speak to the confirmed versus unconfirmed reported outcomes in the PTCL study on with the additional CR now. And just just to clarify how many of those are confirmed versus unconfirmed, and then we'll come up and they're all peripheral.
Okay.
Thank you.
Richard Miller
Yes. And Jeff, I might also add that usually in relapse disease, we don't most clinicians don't really talk about confirmed and unconfirmed that's more appropriate in front-line therapy in relapse disease, especially in this disease people with such a short time that in film capture cases it's difficult to even get people beyond a few months.
Jeff Jones
So but all of our responses are confirmed partial in countries, the swimmer plot you're showing it looks like there are some patients who are still quite early in treatment. And so it almost looks like you're still enrolling patients in that study. And so I guess, are you still enrolling patients in that Phase 1 study? And would you be able to perhaps roll those patients over to the Phase 3?
Richard Miller
We are not enrolling new patients in the Phase 1 study. The patients that are shown on the swimmers and waterfalls and some and some of them are continuing on therapy will be followed, of course, and continued on therapy until they progress. But there's no new patients being enrolled in the in the Phase 1, we're focusing our centers now many of the centers that participated in the Phase 1 are participating in the Phase 3. So we've got those guys now focused on the Phase 3 trial data.
Jeff Jones
Thanks. I'll jump back into the queue.
Operator
Roger Song, Jefferies.
Leon Chang
Hi this is [Leon Chang] of Roger. So thank you for taking our questions. I think two questions from us. I think the first one also collecting it. It was updated Phase 1 data so forth of the five patients with tumor reductions that did not meet your criteria of Bob PR. So how long were the on the treatment and have been for the two that I continue. How long have they been on the treatment? Then I have a follow-up. Thank you.
Richard Miller
As for the all right for those that didn't, that are the first question has to do with for those who have not reached the criteria for a PR, how many are still how long are they still on treatment? So if you look at the swimmer, that would be one is which by the way you can do it yourself is five months, one is about six months. Another one is seven or eight months.
Okay. And the other ones have been TDRs. So that's that's my quick look at this winter. And the second part of your question was what?
Leon Chang
Over the acute data continuously on the treatment. So yes, I guess you're not taking anyone the treatment
Richard Miller
patients continue on treatment until they progress or are they have some sort of a safety issue, but that's not not happened.
Leon Chang
Sure okay. Exactly (inaudible) Yes, yes. On I think my second question is about that Phase 1 study in eight of the committees. So the patients are right prior to fill at least one prior. So any specifics requirements on that?
Richard Miller
I didn't quite hear. The end of your patients are required to have failed one prior topical or systemic therapy, they're required to have moderate to severe atopic dermatitis. They're requiring to be to have failing their prior therapy. Does that answer your question?
Leon Chang
Yes, yes. Okay. Thank you. That's all from us.
Richard Miller
Thank you for the question.
Operator
Li Watsek, Cantor Fitzgerald.
Rosemary Li
Hi there. This is Rosemary Li on for Lee. Thanks so much for taking your question. And maybe firstly, could you reiterate the benchmarks for the relapsed refractory PTCL and what you're hoping to see? Are there some interference on the call or if I didn't catch that. And then I do have a follow-up question.
Richard Miller
And so Pralatrexate and Belinda stack are currently the standard agents for relapse peripheral T-cell lymphoma and those agents received accelerated approval approximately 15 years ago, and the companies never did the confirmatory trials. So there is no currently fully FDA approved drug for relapsed PTCL, Pralatrexate and LymphoStat are basically chemotherapy drugs, Belinda status and HDAC. inhibitor. Pralatrexate is a folate antagonist.
Both of those drugs suffer from the usual chemotherapy toxicities, which are neutropenia, thrombocytopenia, anemia proud pralatrexate suffers from an additional toxicity or mucositis on the response dose study. Those patients the approval for the of those drugs was based on single-arm Phase 2 studies that enrolled somewhere between 100 and 120 patients and the response rate was about 25% on the PFS progression-free survival was in the case of Belinda is that I believe it was 1.6 months.
And in the case of pralatrexate, it was around three months if my memory is correct, we have a slide about this up on the slide presentation on our website. So we see a 33% response, 33.3% response rate with more than half being CRs CR rate in ours. Is about double that of the 25% or so response rate with prioritizing and Belinda said, about 10% with CRs in our responders, most of the most of the responders are CRs, albeit a small number. So CRs are very important in hematology and especially in the lymphoma world.
And the progression-free survival in our hands is 6.2 months which is substantially better than the 1.6 and 3.0 months I mentioned earlier. So we our study of this to go on because I think I know we had the our study design, the statistical design is to is to enroll 150 patients, 75 in each arm standard of care versus So call it 75 in each arm. As I mentioned, we are and the power we have at that 89%, 90% power to see an improvement from about 3.5 months to 5.5 months, which is our target.
Leon Chang
Okay. Thank you so much. Yes, thanks for the really thorough answer. And then I just have a quick question on them. Atopic dermatitis. So for the data that we may get later this year. Do you have any anticipation around like the nature of that data and the patients, how many doses or is it just too early to tell. Thanks.
Richard Miller
But no, we have very good, very good estimation of that. Okay. So so first of all, we know a lot about the dosing of this drug already since we've been evaluating it in patients with lymphoma, we know a lot about the pharmacokinetics, the occupancy of the target, the safety, et cetera. So we are going to be studying four cohorts of patients that are enrolled sequentially.
But we start with, let's say, the low dose cohort, which in our case is 100 milligrams BID, 200 milligrams the ideas are dose in the lymphoma studies and in the proposed Phase 3. So 100 milligrams BID will enroll 16 patients in a three to one randomization where 12 will get, so call it mid and the other four get a placebo arm. Then then we go to the next dose regimen, which is 200 milligrams once a day and because we think that once-a-day dosing will be effective and we think it's more convenient, of course.
So same thing, 16 patients go in there, again, three to one randomization, 12 get the so-called witness for get the placebo. And then we go to the end of the third cohort where that which is 200 milligrams twice a day, the same regimen that we're using in lymphoma, same same idea, 12 patients get the drug four get the placebo again randomized.
And then the final cohort would be 400 milligrams once a day now the reason that we're studying those cohorts is that we know that at 200 milligrams, you get complete occupancy of the receptor and 100 gives you pretty good occupancy but not it's not complete, but probably good enough to cause some biologic effects. So I would not be surprised if we see some effect at the even at the lowest dose regimen.
So as I mentioned earlier, the doctor and the patient are blinded, the company has not so we can look at the data and we have a data monitoring board that can look at the data after each each cohorts enrolled and we're able to report that data or or not. I mean, I don't anticipate we're going to be reporting it every week. But at our discretion, we can be reporting that data.
Now there's also a very rich amount of biomarker data that's going to be accumulating during the study. We're measuring a number of different cytokine and lymphocyte subsets, et cetera, et cetera. And we know already from our lymphoma studies and our other animal studies that we've done and published, we know what biomarkers, what cytokine are effective like IL4, IL5 and and others. So what we would be looking for at each cohort, of course, is safety.
We would be looking at changes in biomarkers in our treatment group relative to baseline, we would expect to see changes in IO four and five. And through all these things, as I compare each patient to his or her baseline and of course, will be doctors will be assessing the efficacy based on the grading criteria.
As I mentioned earlier, the easy score and the global Investigator Global Assessment. So we're going to learn a lot from each disease.
Now in terms of the dosing, we, as I mentioned, we know a lot about the dosing already. So we're able to start at 100 milligrams BID. I would expect to see something very early in this study, and I think we'll get an idea of very early not only about the efficacy but also about the biologic activity because remember, the reason that we're picking a atopic dermatitis first is that it is very much a T what's called a TH. two T helper cell to disease and a disease mediated by IO four and five and 13.
And we we know that our drug blocks the Th two function very well. We learned this from our lymphoma studies and from our other other studies, preclinical studies. So we're going to be able to determine very early in the study about safety we already know that from our lymphoma studies, we'll be able to determine whether or not we're having the immunologic effects that we expect.
And of course, we'll be monitoring the clinical efficacy. Now the immunologic effects are important because this becomes the entry point, the stepping stone to other immune diseases. What are the other immune diseases? Asthma is one that would be very much Th two and psoriasis scleroderma, several other diseases. We have a whole list of them on our on our website, the presentation.
And so so this is a very important study in that we get data quickly, and it's very informative, not only for the purpose of atopic dermatitis, but it opens up the whole field. We would basically this study puts ITK. inhibition on the map as a important therapeutic modality for a host of immune diseases is very reminiscent of an antibody that I worked on called Rituxan and where we what we learned in lymphoma taught us about what happens to B cells, et cetera. And that opens the door for a lot of other dermatologic and immunologic diseases. So that was a long way to answer your question, but I wanted to make sure that we really had a proper perspective.
I appreciate the question. Did (inaudible) --
Rosemary Li
Thank you so much.
Operator
Thank you. And there are no further questions at this time. I'll turn the floor back to Richard Miller for closing remarks.
Richard Miller
Thank you, operator. Well, I want to thank everyone for participating in the call today, and we look forward to giving additional updates each quarter and from advancing social witness and other products in the coming months. Thank you very much.
Operator
Thank you. This concludes today's call. All participants may disconnect have a good day.
