Corvus Pharmaceuticals Q1 2023 Earnings Call Transcript

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May 8, 2023

There are 8 speakers on the call.

Operator

Afternoon, ladies and gentlemen. Thank you for standing by, and welcome to the Corvus Pharmaceuticals First Quarter 2023 Business Update and Financial Results Conference Call. At this time, all participants are in a listen only mode. Later, we will conduct a question and answer session and instructions will follow at that time. Please note this event is being recorded.

Operator

It is now my pleasure to turn the call over to Zach Kubo of Real Chemistry. Please go ahead, sir.

Speaker 1

Thank you, operator, and good afternoon, everyone. Thanks for joining us for the Corvus Pharmaceuticals First 2023 Business Update and Financial Results Conference Call. On the call to discuss the results and business updates are Richard Miller, Chief Executive Officer Leif Lay, Chief Financial Officer James Rosenbaum, Senior Vice President of Research 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.

Speaker 1

Forward looking statements are based on estimates and assumptions as of today and are subject to risks and uncertainties that may cause actual results to differ materially and those expressed or implied by those statements, including the risks and uncertainties described in Corvus' 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 2019 as any forward looking statements, except as required by law. With that, I'd like to turn the call over to Leif Leif. Leif?

Speaker 2

Thank you, Zach. I will begin with a quick overview of our Q1 2023 financials and then turn the call over to Richard for a business update. Richard, research and development expenses in the Q1 of 2023 totaled $4,600,000 compared to $5,100,000 for the same period in 2022. The decrease of $500,000 was primarily related to lower clinical trial and drug manufacturing costs. $1,000,000 noncash loss related to Angel Pharmaceuticals compared to a net loss of $8,300,000 which included a $1,000,000 non cash loss related to Angel for the same period in 2022.

Speaker 2

Total stock compensation expense for the Q1 of 2023 was $500,000 compared to $700,000 in the same period in 2022. At March 31, 2023, Corvus had cash, cash equivalents and marketable securities totaling 30 $4,500,000 as compared to $42,300,000 at December 31, 2022. Looking forward, We continue to expect full year 2023 net cash used in operating activities to be between $19,000,000 $22,000,000 cash burn rate by focusing on our most promising opportunities and establishing collaborations that help support development of our product candidates. Based upon this trend and our focus on CPI-eight eighteen, we believe our cash will provide runway into 2024. I will now turn the call over to Richard who will elaborate on our strategy and plans.

Speaker 3

Thank you, Leif, and good afternoon, everyone. Thank you for joining us today for our business update call. We continue to focus on advancing CPI-eight eighteen, RTK inhibitor towards a potential registration Phase 3 randomized trial for T cell lymphoma. We believe this 1st in class drug not only has the potential to be an important new treatment option for patients with relapsed peripheral T cell lymphoma PTCL, but may also represent a platform opportunity across a broad range of cancers and immune diseases. Recent findings with 818 and important upcoming catalysts are: 1st, we continue to to see good enrollment in our ongoing Phase 1, 1b trial now utilizing our recently incorporated biomarker based on absolute lymphocyte count or ALC.

Speaker 3

And the data generated continues to be encouraging with meaningful objective responses in refractory patients with PTCL. 2nd, we will present additional 2nd quarter. Our next question comes from the line of our Phase 1, 1b clinical trial in T cell lymphoma at the International Conference on Malignant Lymphoma in Lugano, Switzerland in mid June. Call. At that meeting, we will also be presenting biopsy and blood data from patients supporting our proposed novel mechanism of action, which we believe extends the potential clinical indications beyond T cell lymphoma to solid tumors.

Speaker 3

3rd, we intend to meet with the FDA in the second half of the year likely during the Q3 to discuss a plan for a registration Phase 3 clinical trial of CPI-eight eighteen in relapsed T cell lymphoma. We currently anticipate this would be a randomized trial of approximately 150 patients comparing CPI-eight eighteen monotherapy to standard of care chemotherapy agents. The primary endpoint is planned to be progression free survival. 4th, assuming a constructive meeting with the FDA, we plan to be Phase 3 ready with 818, including the initiation of the trial before the end of the year. And 5th, recent data presented at AACR indicates that selective ITK blockade enhances immune responses to tumors, including solid tumors and it achieves this through novel immune mechanisms.

Speaker 3

At the recent Whistler Global Summit on Hematologic Malignancies, Doctor. Jon Renau, a hematologist specializing in lymphoma at the Ohio State University Comprehensive Cancer Center and one of the investigators in our 8 18 clinical trial presented interim data from the trial. This included response data as of February 15, 2023, which we highlighted on our Q4 call. To briefly recap,

Speaker 4

2nd quarter. The patient also highlighted new

Speaker 3

evidence supporting the recently implemented minimum ALC biomarker that we believe will enrich for patients more likely to respond to 8/18 therapy. The new evidence showed that ALC predicted response to 8/18, but was not associated with response to chemotherapy treatments that the patients received prior to their therapy with 818. 2. This indicated that the beneficial predictive value of the absolute lymphocyte count biomarker was not due to selection of more favorable patients. We have recently updated our clinical data from the Phase 1, 1b trial.

Speaker 3

As of May 1, 28 patients were enrolled at the optimum dose of 200 milligrams BID and 19 are evaluable for tumor response. There have been 2 complete responses, 1 nodal complete response and 3 partial responses. 2 of the patients with partial responses continue on therapy and are doing very well. A total of 9 patients remain on therapy, including 5 that have not yet been evaluated for tumor response. For patients with ALC greater than 900, Objective tumor responses were seen in 6 of 13 that includes complete responses and partial responses with disease control in 11 of 2019 that includes CRPR and stable disease.

Speaker 3

No responses were seen in 6 patients with ALC less than 900, 0 of 6. The median progression free survival is 19.9 months versus 2.1 months for patients with ALC above 900 below 900 respectively. Of course, all new patients being enrolled are required to have an absolute lymphocyte count above 900. The more favorable responses in patients with an ALC greater than 900 is consistent with our data that stimulating the immune response against the tumor contributes to the activity of CPI-eight eighteen. We are encouraged by these results and we will continue to enroll patients in order to confirm and extend the findings.

Speaker 3

I also want to say a word about safety. The 200 milligram BI dose is 1 third of the top dose of 600 milligrams BID that we 2 studies in the trial. We have shown that the 200 milligram dose achieved nearly complete ITK target occupancy. No dose limiting toxicities were seen in any dose group, including 600 milligrams BID. We believe this drug is very well tolerated and it should be easy to combine with other types of cancer therapy.

Speaker 3

In April, our team presented new preclinical data at the American Association For Cancer Research Annual Meeting that supports targeting ITK as a new approach for cancer immunotherapy, including the potential to treat both solid and hematologic cancers. The data demonstrated that CPI-eight eighteen enhanced immune response to several murine tumors including models of colon, renal, melanoma and TMB cell lymphomas. In addition, 818 was shown to increase T effector cell infiltration into the tumors and increase the cytolytic capacity of killer T cells. In other findings, 818 was shown to reduce T cell exhaustion, which occurs when T cells are chronically stimulated with antigen, causing them to become reprogrammed and leading to their ineffectiveness. More recent findings show that 818 Can reverse already exhausted T cells, which revert to active T effector cells with renewed killing capacity.

Speaker 3

I want to reiterate the key findings from our ongoing Phase 1 trial in T cell lymphoma and now our recent preclinical data because they suggest a significant broad opportunity with 818. We believe selective ITK inhibition 2019 may represent a new approach to cancer immunotherapy with a novel mechanism of action that includes: number 1, induction of TH1 skewing number 2, increased infiltration of CD8 T effector cells into the tumor number 3, increased cytolytic capacity of CD8 cells and 4th, reduction and reversal of T cell exhaustion. We also continue to extend our intellectual property covering CPI-eight eighteen and Methods of Use for the Treatment of Cancers and Autoimmune Diseases. We believe we have a strong intellectual property position for 818 and are not aware of any other selective ITK inhibitors currently in clinical development. Composition of matter patents have issued in the U.

Speaker 3

S, Japan, Europe, China and other countries already. Turning briefly to our partner led programs, The Kidney Cancer Research Consortium led by the University of Texas MD Anderson Cancer Center is currently enrolling patients in a Phase 1btwo clinical trial with tifiratinib as a potential first line therapy for metastatic renal cell cancer in triplet combination with ipilimumab and nivolumab. 2019. 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. 2.

Speaker 3

Based on current timelines, we believe initial data from this trial could be available before the end of 2023. For mupadolumab, our partner Angel Pharmaceuticals is enrolling patients in a Phase 1, 1b clinical trial in China with mupodolumab alone and together with pembrolizumab in patients with relapsedrefractory non small cell lung cancer and Head and Neck Squamous Cell Cancers. In closing, we believe Corvus is uniquely positioned with the prioritization of CPI-eight eighteen, the most advanced ITK inhibitor in development. We are laser focused on 818 and are gaining increasing confidence regarding its activity in a broad range of diseases including cancers and autoimmunity. 2.

Speaker 3

Our work together with recent publications from others are confirming the crucial role that ITK plays in regulation of the immune system. 2019. Our initial indication T cell lymphoma represents a clear unmet need and a potential path to registration. We are establishing the importance of ITK as a valuable therapeutic target. The key upcoming milestones for our programs include Continued enrollment in our Phase 1, 1b trial led to 200 milligram BI dose of CPI-eight eighteen, including the use of our new biomarker absolute lymphocycount.

Speaker 3

Updated data from our CPI-eight eighteen Phase 1 T cell lymphoma trial will be 2nd quarter. In June, meeting with FDA to discuss a randomized Phase 3 trial in the 3rd quarter and from our partner driven programs, we anticipate interim data from the cifuradenin trial before the end of 2023. 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 Answer period. Operator?

Speaker 5

Thank you.

Operator

We will now begin the question and answer session. To withdraw your question. Chin comes from Aidan Husanoff with Ladenburg Thalmann.

Speaker 5

Thank you. Good afternoon, everyone. Congratulations, So Richard and team with the updates and seems like you have just want to confirm, you have 2 more Responses, partial responses from the new batch of data?

Speaker 3

We have, let's see, 2 more responses.

Speaker 5

Yes, compared to the prior update call that we had at the end of March, right?

Speaker 3

Correct.

Speaker 5

Okay. That's great. So let me ask you about progression free survival. You mentioned 19.9 months. So Based on how many patients was this calculation, could you give us a little bit more clarity on this?

Speaker 3

So that's based on 13 Patients.

Speaker 5

Okay, understood. And regarding Meeting with the FDA. I think, yes, that's a little bit of more clarity. This time you mentioned that this is Going to happen within Q3. So what do you expect from this meeting?

Speaker 5

So you're planning a 150 patient trial, randomized trial. Do you expect any new details Other than what you planned, meaning 101, 1 to 1 randomization or some other randomization And the PFOS primary endpoint. Do you think any surprises will come out of this meeting?

Speaker 3

I do not expect any surprises. I think our protocol is pretty straightforward. It's a randomized controlled trial. Registration of the product for T cell lymphoma. I think things that we want to discuss with them are The choice of standard therapies in the control arm.

Speaker 3

So as I mentioned, it will be monotherapy with 818 versus Standard Therapy for T cell lymphoma. We're thinking now that that would include about 3 drugs, Belinostat and palatrexate are approved for relapsed T cell lymphoma, as you know. And one other drug will probably add 2.2. To the standard therapy list would be gemcitabine, which is widely used for in fact more commonly used in the approved drugs for Peripheral T Cell Lymphoma. So investigators, if their patient is randomized as a control arm, the investigator discretion would allow them to pick one of those 3 drugs.

Speaker 3

Okay. Appreciate that. So Aidan really I think it's just getting an agreement on the design and the standard therapy. But since 2 of the drugs are already approved for relapsed T cell lymphoma And gemcitabine is used by majority of people at least in the United States. I don't think that there'll be too much controversy there.

Speaker 3

Also, the median PFS for these kinds of trials, There have been a few done in the past. It's usually around 3 or 4 months. So I think that we have a pretty good expectation of what the control group would look like. Yes.

Speaker 5

So understood. So it's a kind of historical 3, 4 months versus 20 months that you showed so far. But on ORR side, so far, the back of the envelope calculations show the 46% Something around this on the ALC above 900 group for your drug. But what is the can you remind us what is the historical ORR on the

Speaker 3

25% and very short responses. 1 of the other Yes. By the way, the 40%, 50% response we're seeing, the PRs, I feel confident those PRs are Still responding, for example, as you saw some of that data the other day. So obviously, some of that can change with time. The As I mentioned, the ORR with the standard agents is about 25%.

Speaker 3

That's pretty reproducible. It's short lived. And one of the other things about these control agents They're very difficult to give and they're very toxic. Belinostat, for example, one of the approved agents is an intravenous infusion 5 days in a row every 3 weeks. Pralitrexate is a weekly injection, I think 6 out of 7 weeks, But you have to pay meticulous attention to vitamin B12 and folate metabolism administer that 10 days before and 10 days after.

Speaker 3

It's quite a significant hassle. And those drugs have significant toxicity, bone marrow suppression Being nausea, vomiting, bone marrow suppression, and we really haven't seen any of that. I should add quality of life will also be one of the endpoints that we'll be following. Obviously, PFS is our primary endpoint, but assessment as well.

Speaker 5

Richard, given the difficulty in enrollment and with administration of this chemotherapy Drug. Would you expect the FDA proposing 2:1 randomization?

Speaker 3

I'm sorry, would I can

Speaker 5

you repeat? To propose 2:one randomization as opposed

Speaker 3

to 1? No, I wouldn't expect that. I don't think that would be I doubt they would do that because first of all, 111 statistically is a more powerful study. 2. And we're going to allow crossover.

Speaker 3

So in patients on the control arm, When they progress, they can cross over to the treatment.

Speaker 5

Okay. All right. Okay, Richard, congratulations with the update and

Operator

Q1. Thank you. Our next question comes from Lee Wojtek with Cantor Fitzgerald.

Speaker 6

Hi, this is Rosemary on for Lee. Thanks for taking our questions. Just 2 from us. So for 818, you've mentioned potential in immune diseases as well. So is your plan to generate some initial data there or would you consider directly going to find a partner for those indications?

Speaker 6

2. And then for cifuradenant, seems like the timeline has shifted a bit. So could you possibly give us some color around the reason, Whether it's due to enrollment or just wanting to have a longer follow-up or something. Thanks.

Speaker 3

Okay. First question was, what was the first

Speaker 4

What's

Speaker 3

that? 818. Yes, immune diseases. Yes. So We are very excited about 818's activity in cancer.

Speaker 3

The AACR data, if you haven't seen that, you should Take a look at it because there's some really striking findings in there. We're also very impressed now that there's been another a couple of scientific groups in animal models that have shown that blocking ITK either genetically or using our drug Can Enhance Anti Tumor Responses. So we are laser focused now on T cell lymphoma first and then solid tumors. I've already got a couple of medical centers who are really interested in getting 818 into a solid tumor study. So that's going Take priority over the immune diseases because I think that we have data there already obviously in the clinic.

Speaker 3

We know a lot about it and I think cancer in terms of product approval and development pathway is something that is a little bit easier for us. Now in terms of immune diseases, we're still considering whether or not to move into immune diseases with 818 later this year. However, I think that's going to depend on the progress we make with the cancer in the cancer area. Now one of the things that I should also mention is that we have several backup compounds or next generation compounds to 818 that block ITK in slightly different ways. Some of them have similar chemical structure, some of them have different chemical structures, but we've been doing some additional work on these ITK inhibitors And it's really turning out to be fascinating how we can adjust the biologic properties.

Speaker 3

And I think that we can probably in the future make even make drugs that are even to better design specifically for certain autoimmune diseases. Now your next question on the cifuratinib, no slowdown there. It's being done. I don't know what you're referring to, but MD Anderson is enrolling frontline kidney cancer patients. We have a meeting at ASCO to review all that stuff.

Speaker 3

Other institutions are getting on board. It's an open label trial and the endpoint is CR, CR complete responses and what we call DPRs. And we can we'll get a feel CRs and DPRs are about 30% in the literature from MD Anderson actually. So we'd be looking to see more than 30% CR DPR. And by the way, CRs Are only about 10%.

Speaker 3

So, seeing a couple of CRs would also be highly encouraging. And then finally a word on SIFO and putting it together with Ipinivo. That wasn't done just to add a drug. It was done based on a publication we had in 2018, which showed that the biology, the immunobiology was such that Adenosine A2 antagonism really, really goes well with anti CTLA-four therapy. And I can go into the reasons for that another time, but I think that's also new biology.

Speaker 3

In other words, it's not just 1 +1 equals 2, It's 1 +1 equals 3, I think. Got it. Thanks very much.

Speaker 4

Thank you.

Operator

Thank you. Our next question comes from Mara Goldstein with Mizuho.

Speaker 4

Hi. This is Jerry Gong on for Merit Goldstein. Thanks for taking our questions and congrats on the updates. So first for the 2019 evaluable CPI-eight eighteen patients, can you share the average number of scans patients have had and if the additional six CECL patients are all at the 200 milligram dose.

Speaker 3

The number of scans, You mean the average number of scans? What are you talking about?

Speaker 4

Yes. I guess the number

Speaker 3

Patients get scanned every 2 to 3 months.

Speaker 4

I guess like what is the, I guess, median number time like the time patients have been on study for the 19 efficacy evaluable patients?

Speaker 3

The median time of therapy, I don't have handy right now. But if you look back at our last Conference Call. There was a waterfall plot and a swimmer plot on there. If you go look at that, Jerry, you'll detailed information on how long those people have been on therapy, okay? If I had to guess now, again, I don't have that information handy, 6 months We have several patients still on therapy, including PRs.

Speaker 3

All right.

Speaker 4

Got it. Yes, sure.

Speaker 3

Actually, I think it is coming back to me now. Hang on a second. The number of patients in our study Who are on therapy more than 6 months is something like 65%.

Speaker 4

Okay.

Speaker 2

Correct.

Speaker 3

So that means the median would be more than that, I guess. Look at our look at the data from our last call. Got it. We'll do.

Speaker 4

I guess, are the additional 6 Cabela patients and all remaining patients, I guess, even on study still. Are they all at the new 200 milligram dose? Yes. Yes. Got you.

Speaker 4

For the 5 remaining patients without initial scan. Can you share what their ALC is?

Speaker 3

I think they're all above 900. We started implementing yes, they're all above 900 Because we started implementing that a few months ago. December, I think.

Speaker 7

Yes.

Speaker 4

Got it. And final question for me. So for the ongoing or I guess a follow-up to the Ciproditant question earlier. How many patients do

Speaker 5

you expect to be able

Speaker 4

to share data from by the end of the year?

Speaker 3

With some follow-up? More than 10.

Speaker 4

Got it. Awesome. Thanks for taking our questions and congrats on the update again.

Speaker 3

All right. Thank you, Mara Goldston equivalent, Gerry, I

Operator

guess. Thank you. Our next question comes from Roger Song with Jefferies.

Speaker 7

All right. Great. Thanks for update and taking our questions. A quick one. So for the Phase 3 A1a in TCL, understanding you will do the PFS as the Time endpoint.

Speaker 7

Is that possible you will take some interim look at the ORR or some other Endpoint Potentially For Early Fighting OR Interim Data Look and also for the solid tumor plans. So with the AACR data, Do you have any timeline for the clinical plan there? Thank you.

Speaker 3

Okay. Thank you for the question, Roger. 2. So, yes, we do have plans to do an interim look At the data and evaluate response rate consistent with recent guidelines that came from FDA on accelerated approval. I don't want to make any promises about that.

Speaker 3

And the reason is that the median Time to progression in the controls is so short that I'm not sure there's a big time difference between When you would look early for response rate versus waiting for the final event driven endpoint. You follow me?

Speaker 7

Yes, I got you. Yes.

Speaker 3

So I'm not sure it makes a big difference, but of course we would look at that. And that's another thing of course to be discussed with FDA. But I would say in this particular disease, it almost doesn't matter so much because those the timing is not going to be that different. I mean, it's relative. It might be a few months difference.

Speaker 3

That could be yes, I mean, I guess that could be significant. And then your question on the solid tumors. Right now, we don't have any definitive plans as to when we would start a solid tumor trial. But We've been talking with people about diseases like renal cancer, lung cancer, melanoma and looking at The drug in PD-one resistant patients for example. The good news is there's a lot of patients to receive the anti PD-one, PD L1 agents, 1,000 and 1,000.

Speaker 3

The bad news is there's a lot of resistant patients. Most patients eventually fail it, either don't respond or have a recurrence. And so one of the things we're particularly interested is in that mechanism of resistance. And So those are discussions still going on. Obviously, we're as I mentioned during our talk in my talk, we're laser Focused on the T cell lymphoma work right now and getting that going as quickly as possible.

Operator

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.

Speaker 3

Thank you, operator, and thank you everyone for participating in the call. We look forward to updating you in the future on the progress we make.

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