Corvus Pharmaceuticals Inc. Q1 2023 Earnings Call
Good afternoon, ladies and gentlemen, thank you for attending by and welcome to the harvest 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 it is now my pleasure to turn the call over to Zack Cubo of real chemistry. Please go ahead Sir.
Thank you operator, and good afternoon, everyone.
Thanks for joining us for the Corvus Pharmaceuticals first quarter 2023 business update and financial results conference call on.
On the call to discuss the results and business updates are Richard Miller, Chief Executive Officer, Lifeway, 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.
We're 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 from those expressed or implied by those statements, including the risks and uncertainties described in Corvus. Its 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 Lifeway lift.
Thank you Zack I'll begin with a quick overview of our first quarter 2023 financials, and then turn the call over to Richard for a business update.
Research and development expenses in the first quarter 2023 totaled $4 $6 million compared to $5 1 million for the same period in 2022.
The decrease of <unk> $5 million was primarily related to lower clinical trial and drug manufacturing costs.
Net loss for the first quarter 2023 was $7 $9 million, which included a $1 $7 million noncash loss related to Angel pharmaceuticals, compared to a net loss of $8 $3 million, which included a 1.8 million.
Million noncash loss related to Angel for the same period in 2022.
Total stock compensation expense for the first quarter 2023 was point $5 million compared to $7 million in the same period in 2022.
At March 31, 2023 quarters that cash cash equivalents and marketable securities totaling $34 $5 million as compared to $42 $3 million at December 31, two.
2022.
Looking forward, we continue to expect full year 2023, net cash used in operating activities to be between 19 and $22 million at the midpoint. This is a 24% decrease from 2022, demonstrating our continued focus on prudently managing our cash burn rate by focusing on.
The most promising opportunities and establishing collaborations that help support development of our product candidates base.
Based upon this trend and our focus on CPI 818, we believe our cash will provide runway into 2024.
I'll now turn the call over to Richard who will elaborate on our strategy and plans.
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 818, our ITK inhibitor towards a potential registration phase III randomized trial for T cell lymphoma. We believe this first in class.
Not only has the potential to be an important new treatment option for patients with relapsed peripheral T cell lymphoma or P. T. C. L. 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 first we continue to see good enrollment in our ongoing phase one one b trial now utilizing our recently incorporated biomarker based on absolute lymphocyte count or a L. C.
And the data generated continues to be encouraging with meaningful objective responses in refractory patients with P. T C L.
Second we will present additional interim data from our phase <unk> clinical trial in T cell lymphoma at the International conference on malignant lymphoma in Lugano, Switzerland in mid June .
At that meeting we will also be presenting biopsies 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.
Third we intend to meet with the FDA in the second half of the year likely during the third quarter to discuss a plan for a registration phase III clinical trial of CPI 818 in relapsed T cell lymphoma.
We currently anticipate this would be a randomized trial of approximately 150 patients comparing CPI 818 monotherapy to standard of care chemotherapy agents. The primary endpoint is planned to be progression free survival.
Fourth <unk>.
Assuming a constructive meeting with the FDA, which we plan to be phase III ready with 818, including the initiation of the trial before the end of the year.
And fifth recent data presented at AACE, our indicates that selective ITK blockade enhances immune responses to tumors, including solid tumors and it achieved this through novel immune mechanisms.
At the recent Whistler Global summit on hematologic malignancies, Dr genre, now a hematologist specializing in lymphoma at the Ohio State University comprehensive cancer Center, and one of the investigators and our 808 clinical trial presented interim data from the trial. This included response data.
As of February 15, 2023, which we highlighted on our fourth quarter call.
To briefly recap of 13 patients Evaluable for tumor response, we saw durable responses and four patients. Dr. Renault's presentation also highlighted new evidence supporting the recently implemented minimum ALC biomarker that we believe will enrich for patients more likely.
To respond to 818 therapy.
The new evidence showed that ALC predicted response to 818, but was not associated with response to chemotherapy treatments that the patients received prior to their therapy with a one eight this indicated that the beneficial predictive value of the absolute lymphocyte count biomarker was not due to selection of <unk>.
More favorable patients.
We have recently updated our clinical data from the phase <unk> trial.
As of May 1st 28 patients were enrolled at the optimum dose of 200 milligrams B I D and 19 are evaluable for tumor response.
There has been two complete responses one nodal complete response and three partial responses.
Two of the patients with partial responses continue on therapy and are doing very well.
Total of nine patients remain on therapy, including five that had not yet been evaluated for tumor response.
For patients with ALC greater than 900 objective tumor responses were seen in six of 13 that includes complete responses and partial responses with disease control in 11 of 13 that include CRP are in stable disease.
No responses were seen in six patients with ALC less than 900 zero six.
The median progression free survival is $19 nine months versus two one months for patients with ALC above 900, and 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 818.
We are encouraged by these results and we will continue to enroll patients in order to confirm and extend the findings.
I also want to say a word about safety.
<unk> 200 milligram B Idose is one third of the top dose of 600 milligrams B I D that we studied 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 PID. We believe this drug is very well tolerated and it should be easy to combine with other types of cancer therapy.
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 818, enhanced immune response to several murine tumors, including models of Cowen renal melanoma, and T and B cell lymphomas.
In addition, 818 was shown to increase T effector cell infiltration into the tumors and increase the <unk> capacity of killer T cells.
In other findings 818 was shown to reduce T cell exhaustion, which occurs when T cells are chronically stimulate it 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.
I want to reiterate the key findings from our ongoing phase one 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 may represent a new approach to cancer immunotherapy with <unk>.
<unk> mechanism of action that includes number one induction of th one skewing.
Number two increased infiltration of CD eight T effector cells into the tumor number three increased side, a little capacity of CD eight cells and fourth reduction and reversal of T cell exhaustion.
We also continued to extend our intellectual property covering CPI 818, and methods of use for the treatment of cancers and autoimmune diseases.
We believe we have a strong intellectual property position for <unk> hundred eight and are not aware of any other selective ITK inhibitors currently in clinical development.
Composition of matter patents have issued in the U 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 <unk> clinical trial of <unk> as a potential first line therapy for metastatic renal cell cancer and triplet.
Will it be lumia Mab and Novo lab 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 base.
Based on current timelines, we believe initial data from this trial could be available before the end of 2023.
For <unk>, our partner Angel Pharmaceuticals is enrolling patients in a phase <unk> clinical trial in China with <unk> alone and together with <unk> in patients with relapsed refractory 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 818, 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 autoimmune.
Entity, our work together with recent publications from others are confirming the crucial role that ITK plays and regulation of the immune system.
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 <unk> trial led to 200 milligram dose of CPI 818, including the use of our new biomarker absolute lymphocyte count up.
Updated data from our CPI 808 phase one T cell lymphoma trial will be presented at Lugano in June .
Meeting with FDA to discuss a randomized phase III trial in the third quarter and from our partner driven programs, we anticipate interim data from the <unk> 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.
<unk>.
Operator.
We will now begin the question and answer session to ask a question you May Press Star then one on your telephone keypad.
Youre using a speakerphone please pick up your handset before pressing the keys to withdraw your question. Please press Star then queue. At this time, we will pause momentarily to assemble our roster.
Our first question comes from Aden Theres enough with Ladenburg Thalmann.
Okay.
Thank you good afternoon, everyone, congratulations Richard and team with our with the updates and it seems like you have just wanted to have a problem you have two more responses partial responses from the new batch of data.
We have let's see two more responses.
Oh, yes, compared to the compared to the prior update call that we had at the end of March right.
Correct.
Okay.
That's great. So let me ask you about progression free survival, you mentioned 19.9 months so.
Based on how many patients would this calculation can you give us a little bit more clarity on this.
So that's based on.
Okay understood and regarding.
Meeting with the FDA think yes, that's a that's a little bit of more clarity.
This time, you mentioned that this is going to happen in third.
Third quarter.
What what do you expect.
From this meeting so you're planning a 150 patient trial randomized trial.
Do you.
Any any new details other than and then other than what you planned meaning one of one one to one randomization or some other randomization.
And the PFS primary endpoint do you think any anything any surprises will come out of this meeting.
I do not expect any surprises I think our protocol is pretty straightforward.
It's a randomized controlled trial, what we're looking for at this meeting is agreement that this trial is properly designed and if positive would support registration of the product for T cell lymphoma.
<unk>.
I think things that we want to discuss with them our.
The choice of standard therapies in the control arm.
So as I mentioned, it'll be mono therapy with 818 versus.
Sure.
Standard therapy for T cell lymphoma, we're thinking now that that would include about three drugs Belinda stat and proud track side are approved for relapsed T cell lymphoma, as you know and one other drug will probably add to the to the standard therapy list would be gemcitabine, which is wide.
We use for in fact more commonly used in the approved drugs for peripheral T cell lymphoma. So investigators if their patient is randomized phase the control arm the investigator discretion would allow them to pick one of those three drugs.
Okay. If we show that so eight and it Didnt really I think it's just they're getting an agreement on the design.
And.
And the standard therapy, but since two of the drugs are already approved for relapsed T cell lymphoma, and gem side of being as used by.
Majority of people at least in the United States.
I don't think that there'll be too much controversy there also.
The median.
PFS for these kinds of trials.
There've been a few done in the past is usually around three or four months. So I think that we have a pretty good expectation of what what the control group would look like.
Yeah, so yeah so understood.
Kind of historical three or four months versus 20 months that you showed so far but on or our side. So.
So so far I'm back on the envelope calculation that showed a 46% or something around this on the ALC above 900 group.
Are you drunk by what is the can you remind us what is the historical or are on the chemotherapy unapproved drug side.
25%.
And very short responses one of the other yes.
By the way the 40%, 50% response, we are seeing the Prs.
I feel confident those <unk> 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 <unk> with the standard agents is about 25% that's pretty reproducible. It's short lived in one of the other things about these control agents is they're very difficult to give and they're very toxic Belinda stat. For example, one of the approved agents as an intravenous infusion five days in a row every three weeks.
<unk>.
<unk> is a weekly injection I think six out of seven weeks, but you have to pay a meticulous attention to vitamin B 12 in full eight metabolism administer that 10 days before and 10 days after it's quite quite a significant.
A hassle.
And those drugs have significant toxicity bone marrow suppression.
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 as are our primary endpoint, but secondary endpoints of response rate.
Overall survival duration of response.
And Ah.
Quality of life assessment as well.
Especially given the difficulty in.
Enrolment and administration of these chemotherapy.
What do you expect the FDA proposing to two one randomization.
I'm sorry, what.
Can you repeat it.
To proposed two to one randomization as opposed to no I wouldn't no I wouldn't expect that I don't think that would be ideal.
I doubt they would do that because.
First of all one to one statistically is a more powerful study.
And we're going to allow crossover.
So in patients on the control arm.
When they progressed they can crossover to the treatment.
Okay, Alright, okay, Richard congratulations with the update.
Congratulations with additional responses. Thank you.
So much.
Thank you. Our next question comes from late <unk> with Cantor Fitzgerald.
Hi, This is rosemary on for Lee Thanks for taking our questions just two from us so for Avon and you've mentioned potential in immune diseases as well. So as you plan to generate some initial data there or would you consider directly going to find a partner for those indications and then for <unk> and it 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.
Okay.
First question was what was first.
What's that.
And yes immune diseases, yes.
So.
We are very excited about <unk> activity in cancer.
The <unk>.
CR data is you haven't seen that you should take a look at it because some some really striking findings and there.
We're also very impressed now that theres been another a couple of scientific groups in animal models that have shown that.
AD blocking ITK, either genetically or using our drug.
Antitumor 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 808 into a solid tumor study.
So that's going to take priority over the immune diseases, because I think that.
We have data theyre already obviously in the clinic, we know a lot about it and I think cancer in terms of.
Product approval and development pathway is something that.
As 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 is going to depend on the progress we make with with the cancer in the cancer area now one of the things that I should also mention is that we.
We have we have.
Several backup compounds or next generation compounds to $8 eight 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.
And I think that.
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 ESCO to review all of that stuff other institutions are getting onboard.
It's an open label trial and the endpoint is CR CR complete responses.
And.
What we call deep Prs and we can we'll get a feel Crs and Prs are about 30% in the literature may from MD Anderson actually.
So we'd be looking to see more than 30% CR PR and by the way <unk> are only about 10%.
So.
Seeing a couple of Crs would also be highly encouraging.
And then finally a word on CFO .
And putting it together with <unk> that wasn't done just to add a drug it was done based on a publication that we had in 2018, which showed that.
The biology of the immuno biology was such that adenosine <unk> antagonism really really goes well with anti <unk> four therapy and I can go into the reasons for that another time, but.
I think that's also new biology in other words, it's not just one plus one equals two it's one plus one equals three I think.
Thanks, Alright.
Thank you.
Thank you. Our next question comes from Mara Goldstein with Mizuho.
Hi, This is Jerry <unk> gone from Eric Goldstein, Thanks for taking our questions and congrats on the updates.
So first of all the 19 Evaluable CPI eight eight patients can you show the average number of scans patients have had an SD additional stakes Steve Allo patients are all at the 200 milligram dose.
The <unk>.
The number of scans.
<unk> taken a number of patients get scanned every two to three months.
Alright, I guess like.
What is the I guess medium that no time like the tied agent that did on studies for for the $19 exceed obligations.
Oh the <unk>.
Median time on 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 Youll see detailed information on how long those people who've been on therapy. Okay.
If I had to guess now again I don't have that information handy.
Six months or more but we have several patients still on therapy.
Including Prs.
Alright got it yes sure.
Actually I think it is coming back to me now hang on a second.
The the.
The number of patients in our study who are on.
Who are on therapy more than six months is something like 65%.
Okay.
But.
So that means the median would be more than that.
I guess.
But look at our data from our last.
Call.
And we will do.
Or I guess.
All patients are the additional states that exceed all the patients and all remaining patient I guess, even on studies still are they all at the new 200 milligram dose.
Yes.
Yes got you.
For the five remaining patients without initial scan can you share what their ALC is.
I think they're all above 900, we started implementing yes, they're all above 900, because we started and got anything that a few months ago.
December I think yeah.
A question earlier.
Yeah.
With some follow up.
More than 10.
Awesome, Thanks for taking our questions and congrats on the update again.
Alright. Thank you Ross. Thank you Mara Goldstein equivalent Jerry I guess.
Yes.
Thank you. Our next question comes from Roger song with Jefferies.
Alright.
Great. Thanks for the update and taking my question a quick one.
For the phase III.
Hi.
Tcl.
Understanding you will do the PFS as the primary endpoint is that possible you will take some in turn block.
At the <unk> or some other endpoint potentially or when.
What are they fighting or interim.
Data look.
And in.
And also for the solid tumor.
Planned still with ACR data do we do you have any timeline for the Canadian coal plant there. Thank you.
Okay. Thank you for the question Roger.
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 and the reason is that the the median time to progression in the controls is so short that I'm not sure. There is a big time difference between when you would look early for response rate versus waiting for the final event driven.
You follow me.
Yeah, I got you yeah, so I'm not sure. It makes a big difference but of course, we would look look at that.
And Thats 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 the timing is not going to be that different.
Its relative it might be a few months difference that could just yes, 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 <unk>.
Looking at the drug in <unk>.
PD one resistant.
Ah patients for example.
The good news is there's a lot of patients who've received the anti PD, one PD lone agents thousands and thousands the bad news is there's a lot of resistant patients.
Most of 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 are as I mentioned.
In my talk we're laser focused on the T cell lymphoma work right now.
And yet getting that going as quickly as possible.
Alright. Thank you thank you rich.
Thanks.
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.
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 thanks again bye.
The conference has now concluded. Thank you for attending today's presentation you may now disconnect.
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