Q4 2021 Corvus Pharmaceuticals Inc Earnings Call
Greetings and welcome to Corvus Pharmaceuticals, first quarter, 2020 One earnings conference call. At this time all participants are in a listen only mode. A question and answer session will follow the formal presentation. If anyone should require operator assistance. During the conference. Please press star zero on your telephone keypad.
Please note. This conference is being recorded I will now turn the conference over to exactly that a real chemistry. Thank you you may begin.
Thank you operator, and good afternoon, everyone. Thanks for joining us for the Corvus Pharmaceuticals fourth quarter 2021 business update and financial results Conference call.
On the call to discuss the results and business updates are Richard Miller, Chief Executive Officer, and Chief Financial Officer the.
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 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 has annual report on Form 10-K , which was filed today with the SEC and other filings.
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 like what.
Thank you Zach I'll begin with a quick overview of our fourth quarter and full year 2021 financials, and then turn the call over to Richard for a business update at.
At December 31, 2021, Corvus had cash cash equivalents in marketable securities totaling $69 $5 million as compared to $44 $3 million at December 31, 2020.
Research and development expenses in the fourth quarter of 2021 totaled $4 8 million compared to $7 2 million for the same period in 2020, the decrease of $2 $4 million was primarily due to a decrease in clinical trial and personnel costs R&D.
R&D expenses for the full year 2021 totaled 21 point $29 $1 million compared to $31 8 million for the full year 2020.
The net loss for the fourth quarter, 2021 was $9 $2 million compared to.
Net income of $27 3 million for the same period in 2020.
Net income in the fourth quarter 2020 included a noncash net benefit of $37 2 million from the establishment of Angel Pharmaceuticals, which we co founded in October 2020, excluding this item net loss would have been $9 $9 million.
Net loss for the full year 2021 was $43 2 million compared to a net loss of <unk>.
$6 million for the full year 2020.
Also included a noncash benefit from the establishment of Angel Pharmaceuticals.
Total stock compensation expense for the fourth quarter and full year 2021 was <unk>.
$7 million and $4 $2 million, respectively, compared to $1 2 million and $5 7 million for the same periods of 2020.
Looking forward, we expect full year 2022, net cash used in operating activities to be between $34 million and $36 million.
I'll now turn the call over to Richard.
Thank you Lisa and good afternoon, everyone. Thank you for joining us today for our fourth quarter and full year 2021 business update.
In 2021, we advanced our programs and the laboratory and clinical data, we generate it has enabled us to identify opportunities for our product candidates that we believe could represent important new therapeutic approaches to several types of cancers. We.
We enter 2022 with three clinical programs focused on targets of high interest that we plan to advance into patients and earlier lines of therapy and into mid to later stage clinical trials.
I will now elaborate further on each of our pipeline opportunities and plans.
As you know there is now a heightened interest in antibodies targeting CD 73. Following the recent data from Astrazeneca in stage III lung cancer that demonstrated a benefit of adding their anti CD 73, <unk> to their value Mab and anti PDL one antibody.
More recently in February AZ announced data from the Neocart trial, a randomized phase two neo adjuvant trial in lung cancer that confirm the benefit of adding <unk> to the rally map.
There are now several companies pursuing development of an anti CD three agents for cancer and other diseases. We believe we have a very differentiated antibody demonstrated by the substantial laboratory and clinical data behind it.
We also have discovered key biologic properties of the CD 73 target that are helping us develop and expand clinical opportunities not only in cancer, but other diseases as well.
Briefly the key Differentiators for <unk> include number one it binds to <unk> 73, with Picomolar affinity and completely blocks adenosine production.
Two it's binding to <unk> 73 is concentration dependent and plateaus without a hook effect three it's binding does not cause engine internalization, there's no loss of antigen for it binds to a unique epitope on the CD 73 protein.
And this has now been confirmed by cryo electron microscopy studies, which enabled us to determine the molecular structure at atomic resolution.
Five most importantly, it it's binding to 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 want to repeat that this property is not dependent.
On a dentist team our results demonstrating b cell activation and differentiation has been presented at meetings and published.
Several recently published papers by others are confirming the importance of b cells in the tumor microenvironment.
Briefly the presence of b cells and plasma cells confers a favorable prognosis and is predictive of response to immuno oncology agents.
Six last in clinical trials involving over 100 patients we have determined safety dosing PK PD and immunologic effects. We have reported early signs as anti yet antitumor activity in lung cancer and other tumors.
The data have led us to a therapeutic approach of.
Combining <unk> mab, which serves to step on the gas or drive them being responses combined with checkpoint blockade to release the brakes on the immune system together. We believe these complementary therapies may improve the immunotherapy of cancer.
This is now being tested in ongoing phase one two trials in advanced refractory lung and head and neck cancers, we anticipate presenting data from these cohorts in the second half of 2022.
To build on this we plan to initiate a randomized blinded phase two study in the frontline treatment of patients with stage four non small cell lung cancer <unk>.
Approximately 150 patients will be randomized to therapy with <unk> in combination with timber iliza med and chemotherapy.
Or two therapy with timberland chemo alone, which are approved standard of care therapies for this indication.
The primary endpoint will be progression free survival and secondary endpoints include response rate and overall survival.
Chemo and <unk> are approved for stage four lung cancer, regardless of PD lone expression on the tumor so a very high proportion of patients with stage four lung cancer are eligible for this trial, we anticipate that we can start this trial in the third quarter of 2022.
Let me now discuss CPI 818, our ITK inhibitor.
ITK is a homolog of P. T K and is involved in T cell activation and T cell proliferation.
As you May know be Teekay inhibitors are now widely used in the treatment of B cell lymphomas and several members of the Corvus team played crucial roles into discovery and development of Ibrutinib. The first be TK inhibitor.
The idea here is that CPI 818, which is a small molecule orally administered drug will block malignant T cell proliferation and be useful in T cell lymphomas, and perhaps in autoimmunity and allergy by blocking the proliferation or activation of T cells that are <unk>.
Vault in these diseases.
At the Ash meeting American Society of Hematology meeting in December 2020, we presented data in patients with peripheral T cell lymphoma or P. T C L treat it with it with 818.
We saw one complete response and one partial response out of seven patients with very advanced refractory P. T. C. L I might add that that see our last at 19 months.
Additional laboratory studies demonstrated that CPI 818 is having rather remarkable effects on lymphocyte populations and functions.
Our partner in China Angel Pharmaceuticals has licensed CPI 818 for the greater China territory, and we are working with them to conduct expanded clinical trials in China and in the U S and other countries. A key motivation here is that T cell lymphomas are more common in Asia than in North America.
In Europe .
Angel is now enrolling patients in a phase <unk> trial of CPI 818.
I am happy to report that the initial antitumor activity, we reported on at Ash has been confirmed in the Angel clinical trial.
I'll also add that Angel has this enlisted the top academic clinical centers in China led by the Beijing Cancer Center at Peking University.
Looking forward, both Corvus and Angel will continue enroll patients in the in these phase <unk> trials and we are aiming to present data from these studies in the second half of this year.
We are advancing our third clinical program so for adamant in frontline renal cell cancer in a triplet combination with an anti PD one anti <unk> four therapies.
We believe there is very strong rationale for this novel combination, which is based in our on our publication in cancer Immunology research in 2018.
Briefly in those studies, we showed in several animal tumor models that sypher adamant combined with anti C. T. L. A for an anti PD ones, we're highly active resulting in a high proportion of cured animals, even in the setting of treatment of established tumors.
In addition to the preclinical studies noted here, we have published and presented clinical data and very advanced refractory patients with renal cell cancer, demonstrating antitumor activity with <unk> as monotherapy and together with anti PD one therapy.
As you May recall, we also identified a biomarker the adenosine gene signature that predicts response to a dentist blockade. These findings have been confirmed by other academic groups.
Based on our preclinical and clinical results.
In recent emerging clinical data showing that the combination of it'd be lula mad and devoted a mab produce long term plateaus on progression free survival and overall survival curves the kidney cancer clinical trial consortium and Corvus plan to conduct a phase two trial in front.
Line renal cell cancer focused on the triplet combination of sypher, Adnan plus it would be and levo.
The trial will enroll about 60 patients and the primary endpoints will be deep responses and progression free survival deep responses or complete responses and partial responses with greater than 50% tumor reduction.
The rationale behind this trial is to raise the plateau on progression free survival and survival by adding sypher, adding at the.
The kidney cancer consortium is led by M. D. Anderson and includes several leading centers such as Vanderbilt Beth Israel in Boston, Cleveland Clinic, Ut southwestern and others.
This study is on track to begin in late April of this year.
Since this is an open label trial I anticipate that we will get a good feel for efficacy early in the trial.
To summarize our near term opportunities moved the Dolan Mab as a differentiated anti CD 73 antibody that we are developing for lung cancer initially.
It is being utilized in a novel immunotherapy approach based on B cell activation and long term. We believe it has broad applications in other cancers and infectious diseases. We also are exploring partnering opportunities to expand mubadala maps development scope.
CPI 818 is being studied for T cell lymphomas and these studies are elucidating dramatic effects on T cell function, which we believe bode very well for other diseases like auto immunity and allergy.
Together with Angel, we continue to treat patients in our trial here in the United States, Canada, Australia, South Korea, and in China with a goal of initiating a global phase II study.
And sit for admin is now positioned to begin clinical evaluation in first line renal cell cancer using a novel approach aimed at increasing complete remissions in deep responses.
One final point to highlight working with Angel and the kidney cancer consortium allows us to conduct multiple comprehensive clinical trials very cost efficiently.
Combined with a solid balance sheet, we have the resources to execute on our three quote on our three clinical programs through several key milestones over the next couple of years.
I will now turn the call over to the operator for Q&A operator.
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Our first question is from Lee <unk> with Cantor Fitzgerald. Please proceed.
Hey, guys. Thanks for taking my questions I guess first one Uh huh.
I guess from a long trial. It seems like you plan to do a phase two instead of doing a phase two and three so maybe just talk a little bit about what's behind the plan here and then you mentioned that you see the phase two trial.
Got caught out this year. So I'm just wondering what are the gating that's here.
Ah Okay Lee.
We decided to go with a randomized blinded phase II trial, because that gives us more ability to look at the data it's not a registration trial, it's not viewed as a registration trial by the FDA. So we're able to look at the data in and.
Evaluate efficacy along the way now were not going to be looking at the data you know on a continuous basis, we have built into the phase II trial interim points, where we will take our.
You know control looks at at what's going on from an efficacy standpoint, we have a phase III trial teed up and ready to go the minute. We are convinced that there is a good signal from an efficacy standpoint, we fire up the phase III trial, which would be a larger study.
Basically this is a way to efficiently manage our phase two moving into phase III, conserving capital and being able to look at the data now once we start the phase three of course, we can't look at the data until the trial is done.
Now your sorry, the second question was on the.
Yeah. So what are the gating items for starting.
The gating items are just are getting our sites lined up.
Getting.
Our IRB approvals vendors et cetera, I mean theres no.
You know no more logistical items than anything else.
Okay. Thank you.
Our next question is from Mara Goldstein with Mizuho. Please proceed.
Oh, thanks, so much for taking the question.
Uh huh.
Cohorts for them up to tell on that.
That was in process, where you are now in terms of enrolling a cat does a 15 patient cohorts and.
Specific indications I think it was non small cell lung cancer and head and neck cancer indication I. If you don't mind me asking and then.
Do you have a sense of when or might be data from CPI 818 that you'll be available that would be available to share.
Ah Okay. The expansion cohorts with MOOC are enrolling a head and neck is enrolling very nicely hope to report some data on those later this year now keep in mind those are very different patients than the than our randomized phase two I mentioned, the randomized phase two in lung as frontline.
The lung and head and neck that we're enrolling now as a second third fourth fifth lines. There right. So they're very different patients and I and I don't consider that information to be gating on our phase two at all and other people are saying that to these late line patients are very very different.
Your question on eight eight <unk>.
Let me just say one is exciting product and were enrolling patients and we're gonna and present data later this year, maybe ash or something like that I think that the biology, that's coming out of this is extraordinary.
I think that this is.
A really pretty cool target.
Okay, if I can just.
But clinical program there.
It is the sort of global design is that a function of maybe what occurred at the central him out of FDA AD com or was that always anticipated.
<unk> to enroll patients outside of Asia.
Wells until them, that's got nothing to do it.
Our plan was always to enroll patients in North America, and Australia, and and we did the deal.
We formed Angel.
To accelerate our global development, we don't intend to just enroll the trial with Chinese patients. I mean this is the majority of patients in what we're doing now are going to be from North America.
Okay. Thanks, so much.
Yeah.
Our next question is from Roger song with Jefferies. Please proceed.
Great. Thank.
Thank you for taking our questions. So maybe for the first one for the phase two of course.
And then rich.
I can just.
A little bit about the powering assumption for these patients also you mentioned.
So well have the multiple companies, where a lot just to confirm.
One goes into a lot.
The Africa sneak them over there.
The phase III.
Okay. So first of all it's 150 patient trial its not a registration trial the phase II part of this so I'm not sure what the.
Where youre going with power or Rfps out he was but but.
We would be I would like to.
We'd be able to look at this data after.
75 events, let's say.
75 to 100 events events being progression you know in a phase II trial with 150 patients the power calculations and P values are a little bit different I would I think if we had a hazard ratio between the treatment and control groups of a.
<unk> seven that would be very very good but of course, we'll look at response rate and other things now keep in mind that a chemo plus kimbro for all comers with lung cancer, a wild type not excluding al can and Egfr mutations has a PFS median of about eight months.
That's not very good which is why.
We're interested in and this trial, because we think adding move the.
I mean, there's a good chance, we think adding a third agent to that could improve upon that so now in the phase three trial, Roger that would be a trial with I don't know 700 patients and and an interim look maybe a third of the way through there you might be looking at a a hazard ratio of 0.8 pet that.
B, 90% power to get yourself.
People want O two five.
So that makes sense.
No that's great.
They've got a kind of a color around those hazard ratio sure Oh, okay.
Okay. So that's that's that's very good one.
Just to clarify for the H eight data, you're saying second half this year and maybe I'm wrong as well that includes your own phase <unk> data otherwise the NGL kind of where that's.
That's just quite a while on the other.
I think it would include both but theres a lot of parts to this there's the clinical data.
And there's a lot of very interesting biologic data.
Yeah, you have to realize that this is.
This has never been done before right C. D. ITK inhibition, just like a one month when my grouped at Beachy Kay that was a completely pioneering work.
And that's what we're seeing here and all I can say is that this is a really interesting target.
Yep got it yeah, so I can check.
Al.
And we're going to be very cautious in how we talk about this because there's a lot of interesting science, there's a lot of new targets that come about as you investigate this new strategies new diseases. So this is something that I think you'll be hearing more about.
And then in the future.
Got it okay great.
Maybe just one last one if I may for the a few more things.
As a biomarker.
How would that be incorporated.
Ah kidney clinical trial consortia phase two are you you have a kind of a way to kind of.
Okay Great question.
Roger.
So first of all let me say that the adenosine gene signature has been confirmed by one major academic group and it's a publication. That's impressed now by this other academic group so.
That that signature appears to be very important in renal cell cancer.
Now we are going to measure it in our frontline renal cancer study with the kidney cancer consortium, but we're not going to gate on it we're not going to exclude people based on it.
As you recall in patients with metastatic recurrent disease, it's about half of the patients that are positive for this gene signature now in the frontline setting there's a lot to be learned I don't know how common it will be in the frontline and its predictive value could be different which is why we don't want to get on it we need to collect that information and so we'll have <unk>.
<unk> on patients, who are identifying gene signature positive and negative and.
And we will see.
Got it Yep. Thank you, Florida comments are really helpful.
Im quite sure that corporation. Thank you.
As a reminder, this star one on your telephone keypad, if people would like to ask a question. Our next question is from Arthur.
He with H C. Wainwright. Please proceed.
Hey, good afternoon, Richard and their live so I just wanted to follow up on the.
The stars.
Trial for the first line lung cancer.
I believe for Astrazeneca called the coast study.
It's worth a stage three.
Lung cancer patients.
And if I recall correctly, you mentioned the stage four so could you walk us through your thought at processing. How did you why you choose the stadium for <unk>.
Versus say the three for these trial.
Sure.
So.
The reason one of the reasons Astrazeneca did stage III lung cancers, because their value map their anti PD L. One was approved for stage III.
Frontline. So it was you know more business reason than anything else.
And they are well well being a dominant and anti PD one for for for stage three it is not a dominant antibody for for stage four stage four is far more common by the way stage four diseases is is metastatic disease.
And that's that's way more common.
Stage three is is patients who have locally advanced disease, they get chemotherapy and radiotherapy and then they went on adjuvant to revalue mab or valium ABA Leclair map. So it's a very different clinical setting it's a little earlier, but there would be no reason to think that the biology that to you.
Oh biology of the lung cancer cells in stage three versus stage four is different we selected stage four because it's far more common we have some responses we've seen in metastatic disease with <unk> alone in patients who have failed PD ones and we're gonna put partner R. R. R.
Lupo with Pember Elizabeth.
Which is as you know is approved as an approved agent for stage four lung cancer. So those are the reasons, it's not really.
AZ has a focus on stage three.
Has to do with the fact that that's where they found their position back a couple of years ago with their Pacific trial.
Okay got you thanks for that clarification and I'm just curious.
The potential.
Registration trial for <unk> for the first line.
Lung cancer are you guys are open to the design to including even possible for the triplet including separately.
I'm, sorry, the triplet, including what.
Set for rather than rather than adding the HOA blocker to it yeah.
We'd be open to considering it but I mean right now we have you know this is a pretty straightforward designed both for phase two in and potential phase III, It's pembaruan chemo, which is approved for all stage for lung cancer.
Except for the Egfr and <unk> mutations are.
And you know, adding move on top of that now if you want to add to experimental agents on top of it that gets a little bit more complicated.
Okay. Thanks, Thanks for the additional color.
Okay.
Alright.
Okay first thank you all for participating in the call. We look forward to updating you on our future progress. Thank you very much.
Okay.
Thank you. This does conclude today's conference you may disconnect. Your lines at this time and thank you for your participation.
Yes.
Yes.
Yeah.
Okay.
Okay.
Yes.