Q3 2022 Corvus Pharmaceuticals Inc Earnings Call

Good afternoon, ladies and gentlemen, thank you for standing by and welcome to the Corvus Pharmaceuticals third quarter 2022 business update and financial results Conference call.

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.

It is now my pleasure to turn the conference over to Jackie pile of real chemistry. Please go ahead Sir.

Thank you operator, and good afternoon, everyone.

Thanks for joining us for the Corvus Pharmaceuticals third quarter, 2022 business update and financial results Conference call.

On the call to discuss the results and business updates are Richard Miller, Chief Executive Officer, Lastly, Chief Financial Officer, and James Rosenbaum Senior Vice President of research the executive team will open the call with some prepared remarks, followed by a question and answer period.

I would like to remind everyone that comments made by management today and answers to questions will include forward looking statements.

Forward looking statements are based on estimates and assumptions as of today 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 <unk> 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.

I'd like to turn the call over to Leslie.

Thank you Zack.

Begin with a quick overview of our third quarter of 2022 financials, and then turn the call over to Richard for a business update at.

At September 30th 2022 quarters had cash cash equivalents in marketable securities totaling $49 $6 million as compared to $69 $5 million at December 31, 2021.

Based on the recent prioritization of our clinical stage pipeline plans, we believe our cash will provide runway into early 'twenty 'twenty four.

Research and development expenses in the third quarter of 2022 totaled $10 $4 million compared to $7 million for the same period in 2021, the increase of $3 $4 million is primarily related to a $5 5 million dollar increase in drug manufacturing costs, which was partially offset by a $2.

$2 million reduction in clinical trial costs.

As you can see we continue to prudently manage our cash burn rate, while advancing our portfolio of product candidates.

To achieve this by careful utilization of experienced personnel leveraging external resources in establishing collaborations that help support the development of our products.

For the same period in 2021.

Total stock compensation expense for the third quarter of 2022.

Point $7 million compared to $1.1 million for the same period in 2021.

Now turn the call over to Richard who elaborate on our strategy and plans.

Thank you life and good afternoon, everyone.

Thank you for joining us today for third quarter 2022 business update we are excited to share an update on our clinical programs, which aimed to bring new therapeutic approaches to a range of diseases, including cancer and immune mediated diseases, we intend to accomplish this by modulating the activity of immune.

Sells utilizing our precisely targeted drugs.

As we approached the end of the year, we our position for a series of potential catalyst across our portfolio with a goal of expanding our ability to help more patients.

Our lead program is CPI 818 are ITK inhibitor that we believe has diverse opportunities across oncology auto immunity fibrotic diseases and allergic diseases.

CPI 818 is a covalent ITK inhibitor and binds to Itk's similar to the way ibrutinib binds to be TK.

We believe the opportunity with CPI 818 to target T cells is similar to that of PTK inhibitors and anti C. D 20 antibodies that target dsl's for the treatment of both B cell lymphomas and autoimmune diseases.

Importantly members of the Corvus team play crucial roles and the discovery and development of these agents.

We are not aware of any other ITK inhibitors currently in clinical development.

CPI 818 is currently being studied in a phase one one be clinical trial in patients with relapsed T cell lymphoma.

We have identified an optimal dose of 200 milligrams aural twice per day, and Corvus along with our partner in China Angel Pharmaceuticals are expanding cohort of patients focused on this dose.

We announced this morning that data from this study will be presented in a poster presentation at the American Society of Hematology meeting on December 12th.

Previously reported that as of July 22nd there were eight evaluable patients treated at the 200 milligram dose. We had one complete response, one knodel complete response, one partial response and five patients with stable disease. We view these results positively given the severe.

<unk> of the disease. These patients had a median of four prior therapies in the published overall survival of first relapse T cell lymphoma is reported to be a median of five six months and the progression free survival is less than three months and first relapse.

All of our patients had three or four relapses.

The update at Ash will include more mature safety and antitumor activity for patients in this 200 milligram cohort.

In addition, the presentation will include analyses of CPI 818 immune modulation of normal T cells as measured by changes in th one th to th 17 cells and what are known as terminally differentiated T effecter memory cells and various theorems cytokines in blood snap.

<unk> from these patients.

These immunomodulatory effects have very important implications for therapy of auto immune in allergic diseases.

Advancing our strategy strategy for CPI 818, and autoimmune an allergy is a major focus for the company being led by Dr. James Rosenbaum, who joined US in July .

Based on our ongoing work we are increasingly confident that we will initiate clinical trials and autoimmune and or allergic diseases in the first half of 2023.

We also plan to initiate a phase two trial of CPI 818, and T cell lymphoma in 2023.

Dr. Rosenbaum will elaborate on on more of this during our Q&A, if we have time.

We plan to host a conference call and webcast on December 12th at the Ash meeting to discuss the CPI 818 data along with updates on our plans for CPI 818, an auto immune disease an allergy.

Initial details about this call are included in our Ash curtain raiser in third quarter results press releases today, and more specifics will be announced closer closer to the time of the events.

Moving on to sit for redness or adenosine two a receptor antagonist in October the kidney cancer Research consortium initiated a phase one b two clinical trial evaluate evaluating sypher, adding it as a potential first line therapy for metastatic renal cell cancer and a.

Triplet combination with <unk>.

The trial was being led by the University of Texas, MD Anderson Cancer Center, which is one of the seven partner institutions that make up the consortium.

All the members are premier institutions, and others include Beth Israel Deaconess, Duke University University of Michigan University of Pennsylvania U T southwestern in Vanderbilt.

The trial is based on our publication in 2018, showing cinergy sypher adamant with Anticity delay for antibody in preclinical tumor models and data from our phase one studies, demonstrating antitumor activity of safer.

The trial is planned to enroll up to 60 patients with newly diagnosed or recurrent stage for renal cell cancer that have not received any prior systemic therapy.

Patients will receive <unk> 100 milligrams oral twice daily continuously in combination with it b one milligram per kilogram. Once every three weeks for four doses and Nivolumab three miliband three nick's per kick given every three weeks. These are fairly standard regiments for this disease.

The phase one be run in portion will enroll eight patients with primary endpoints of safety Tolerability and antitumor activity in the phase two portion. The primary endpoint is the percent of patients who achieved deep responses. This is defined as see ours complete responses.

And partial responses that have greater than 50% reduction in tumor volume, reflecting our goal to raise the plateau on the progression free survival and overall survival by adding <unk>.

Historical data from these institutions I, just mentioned has shown that deep responses correlate with prolonged progression free survival and is seen in approximately 32% of patients receiving AP nivo.

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.

Next is moot bedolla map or b cell activating anti CD seventy-three antibody wiebe.

We believe <unk> is differentiated in the CD seventy-three landscape as it binds to a unique epitope on the CD seventy-three protein.

Which on peace sells results in their activation and differentiation into antibody producing plasma cells and into memory B cells, we think that the immunomodulatory properties provide a unique mechanism of action in immunotherapy.

We anticipate that in the near term our partner Angel Pharmaceuticals will initiate a phase one one clinical trial in China with moved the Dole Nab alone and together with Pember Iliza map in patients with relapse refractory non small cell lung cancer and patients with head and neck squamous cell cancers in.

The U S. We remained paused, but ready to advanced <unk> into a randomized controlled phase two trial as we continue to focus our resources on the development of 818.

In closing, we believe corvus as well positioned with several potential catalyst for our programs in the next 12 months combined with the cash runway into early 2024.

He up key upcoming milestones include.

New CPI 818 phase one data will be presented that ash in December .

As a reminder, this study includes Angel pharmaceuticals.

Who is responsible for that portion of the study in China, and we are planning a phase two trial for T cell lymphoma in 2023.

CPI 818 development, an auto immune an allergy is ongoing with the goal of initiating clinical trials and the first half of 2023.

With Sypher Dennett phase one b to trial for first line renal cell cancer, we have the potential for a read on clinical activity response rate early in enrollment since it is an open label study.

And the development of <unk> is continuing in China with the pending initiation of a phase one trial by Angel Pharmaceuticals, which could you yield new data next year.

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.

We will now.

A question and answer session.

Ask a question.

And one on your touch.

If you are using.

Before pressing the keys.

Your question please.

Two.

This time, we will pause for a moment.

Pasta.

Our first question today will come.

Please go ahead.

With your question.

Hi, This is Jerry gone gone for miracles thing, thanks for taking our questions and congratulations on the excessive abstract for the ongoing CPI eight on a trial can you confirm if you continue to monitor any patients at higher dose cohorts and can you provide any color as for the breakdown CPI 818 patients on.

The trial in China like at.

U S for Australia. Thank you.

We are done enrolling patients in the higher dose cohorts that is the 400 600 milligram cohorts.

What we will be primarily focused on at the Ash meeting is the ongoing enrollment and follow up of our patients and the 200 milligram cohort one thing to emphasize is.

Based on your question.

Is that we we have identified a very interesting dose response relationship for this drug.

And 200 milligrams is a dose probably 200 to 400 is a dose.

That has we think very important.

Facts on T cell differentiation there.

This has never been described previously.

We think we have.

Interesting intellectual property around this I might add.

And we will be hitting that hard at the ash meeting.

Not only in terms of the antitumor effects, but also the effects on <unk>.

Normal T cell biology.

The second question.

Was.

Jerry what was your second question, yes, sorry, so can you provide any color or ask for the breakdown CPI 818 patients on the trial court in China, and the U S or Australia.

Most of the patients who've been treated on our trial are from the U S. Some from Australia, and South Korea more recently enrollment has has been coming a significantly from China as well as here.

Gotcha and can I ask a follow up.

So China has recently reiterate there's zero Covid policy. So how my best at that current clinical trials in China in one eight and about that trial that just recently.

Got the idea approval.

So we've been monitoring that very carefully I don't believe that the zero Covid policy had Ah.

Substantial impact on our trial in China.

We're only at what four or five centres now and some of those sensors just opened up recently and in the in the last few weeks. It appears that zero COVID-19 policy or the Covid.

Demick in China has has subsided so right now we're.

We're not seeing any any significant impact on that.

Gotcha. Thanks My color.

Our next question today will come from Roger.

Please go ahead.

Great. Thanks for taking my question and a call back for that.

Pro rata, maybe you're rich.

Couple of questions for the L. A I y.

I'm looking at the <unk>.

Prepare the remark you per archiving the auto immune are allergic to.

Each boy Y maybe get to remind us what is the biology.

Trying to drag for Dallas, Dizzy and also can you just confirm with that what will be the next step for a while I, particularly for the U S N a global outside of China.

Okay. So first of all.

Let me emphasize that T cell lymphoma coins.

Continues to be our main thrust, we still view of T cell lymphomas at the most efficient most effective shortest path to approval for a bad disease. We think are drug can help patients with this disease. We continue to believe that we can.

Have.

A significant effect in as a mono therapy and relapsed disease of course over the longer term, we would be looking to combine at an earlier stage patients with lymphoma. So I want to emphasize that T cell lymphoma is still.

Still the main thrust.

Thrust of our activities. However, it is very very difficult to ignore the profound effects, we see in our lymphoma patients very reminiscent of what <unk>.

Myself and my team saw when we started treating lymphoma patients with things like Rituxan and Ibrutinib. We started to notice that there were effects on other b cells in that case in the case of ITK. It's T cells that could really be important for a bunch of other diseases.

So the effects that we see and that will talk about it ash and there's a lot of really cool stuff on our poster.

Ash, where has to do with the effects of 818 on the differentiation of what are called T help ourselves.

No question that this causes skewing or biasing to th one T cells th one cells that are important in killing cancer cells, and killing virally infected cells and there is no question. We have in vivo evidence of this we have in vitro evidence of this that we can cause dramatic inhibition of th too.

<unk> and its resultant cytokines liked Iowa four five IL 13. These are cytokines, there pathologic and diseases like.

<unk> atopic dermatitis scleroderma and many many other diseases.

So the strategy is to blast forward with T cell lymphoma, as best we can but concomitantly invest our resources in initiating auto immune disease trials.

In 2023 and.

I think this might be a good point to turn it over to Doctor Rosenbaum, who can.

Maybe provide a little bit more detail on the question you're asking so the key for us given the large number of opportunities. We have an order of immunity. The key for US is can we can we pick an auto immune disease or allergic disease, where we can get in the clinic quickly get relatively short.

And points and get meaning.

Meaningful clinical data in 2023, and that's what we intend to do now we're going to give a lot more details on this at our Ash conference call.

But Jim maybe you want to add to that.

Okay. Thanks, Richard sure My my pleasure.

As you said 818, bynes covalently to I T. K N I T. K is a T cell enzyme.

It is critical for the generation of so-called th two shelves the subset of T cells that are vital in allergic and a topic disease and fibrotic disease and right now we're leaning toward atopic dermatitis is our first clinical target because the scientific rationale.

Th two cells are involved in that disease is overwhelming.

In addition, it's an unmet clinical need with drugs that are only partly effective are sometimes effective and often drugs that need to be given by injection.

818 of course is oral it has a unique mechanism of action.

And attractively, we believe that we can find clinical efficacy within 28 days show, we intend to be in clinical trials in the spring of 2023, and we expect to have results that will shed light on efficacy before the end.

End of 2023, and as you said will provide more details at the Ash conference on December 12th.

Thanks, Jim.

So Roger.

Any follow up questions on that.

Yeah, I think about that that's great and I look forward to the data from both.

<unk> and <unk> and maybe get a follow up for the <unk> understanding Europe for archiving a y.

<unk> double part in China, So maybe just go away and and <unk>, we will see the update for that a as Apple pie.

Are you at all outside of China.

Okay. So we expect to start enrolling patients in China.

Before the end of the year <unk> has been approved in China.

And.

Angel already has several very good clinical sites lined up with <unk>.

Prominent lung cancer, and head and neck cancer experts of course, those studies are non randomized trials.

But it will include Lupo alone and move it together with <unk> now in the U S.

As you know we have put our our randomized phase two trial plans on hold that was a study in frontline.

Lung cancer.

I don't have any definite plans as to when we would start restart that in the U S. Again were highly focused now on on on 818.

Obviously the situation could change.

Because we have a protocol we have sites ready.

<unk> collaboration.

We're ready to go with our move the phase two trial everything is in place ready to go. It's just that we pause that because we were number one trying to conserve some capital and number two.

Looking to get some results from others, who are working in this field as well.

We've always been suffering from being the pioneer so in this case, we have been the pioneer but now we're going to wait for some of these other things to play out now is of course, Roger as you know there's other lung cancer studies.

<unk> antibodies and other things that are being looked at.

Those results will be coming along.

Soon in the next several months those could also impact our plans.

Got it yeah, Oh, Okay now as long as we're talking about.

Because that's that's.

A good question and we could ask the same thing about sypher Sypher dentists were <unk>. My team is always criticizing me for my pronunciation.

In any event <unk>.

<unk> use in frontline with Nivo is a really interesting trial, the science behind that and the rationale was quite fascinating.

And we have.

Uncovered together with some of our collaborators a really novel mechanism of action.

That's gonna make perfect sense once we laid out for people, we're not willing to do that yet because we want to fortify our intellectual property et cetera.

But it turns out that there is really something special about that.

And I'm really looking forward to.

To that data the other thing about that trial is that it.

It's based on C R and what we called Dpr's.

Already been a couple of publications that Dpr's in Crs correlate with PFS in Oss. So most people who respond are going to respond in three months.

So we would know very quickly very early in the study whether we're having an impact on this deep Trc are right, which I mentioned in my remarks.

Is.

In the literature is about 32%.

Alright.

Awesome, Yeah, great. Thank you for that they should know.

Wow, that's great. Thank you.

<unk>.

Alright.

Ladies and gentlemen, again, if you would like to ask a question.

And then one.

And our next question today will come from <unk>.

Please go ahead.

Hi, This is Rosemary on for me. Thank you so much for taking my question I just want two quick ones. So first Upi 818, how fast do you think you could move into phase two and have you had any discussions with the F. D. A on potential path to approval and then one on <unk> <unk>.

So with the combo with it being evil in front line <unk> could you give us a sense of what would be good data in your view.

Okay. The first question on T cell lymphoma. So again, our plans would be to go into patients mono therapy refractory peripheral T cell lymphomas.

And cutaneous T cell lymphomas.

We have a protocol drafted already circulating around two investigators we have not yet.

Review that protocol with the FDA.

We would intend to start that trial, probably mid year.

And again that would be a single arm trial.

We can talk more about that at the Ash meeting in terms of what our thoughts are on size, but you know you.

Probably looking at a trial of 100 150 patients something like that.

The second.

Question, what would be success.

And.

That's a great question.

Plus we have that as I mentioned in my remarks that.

A couple of papers have shown that deep P. Rmcer is 32% so I want to beat 32%.

There is anything above 32.

Well I mean, I'd, rather be 52, but you.

But yeah, I mean 30 twos your you know your.

Your your your.

Basically historical data recent historical data.

Okay got it thank you so much.

Oh go ahead.

Yeah, just add one thing that.

You know, even though everybody is.

Cited about immuno oncology and Immunotherapies.

It's worth highlighting that.

And there's no question that PFS and O as in many cases in response rates has increased especially in things like.

Reynoso cancer.

But interestingly the complete remission rate complete remission rate is not really increase that much and most good oncologist wants to see ours.

Because crs can turn into cures Prs never turn into cures almost never.

So that's what you'll be looking at is CRM DPR right <unk>.

Response rate.

Okay.

Sorry, operator any other.

Have no further questions at this.

Time.

Okay.

Alright.

Back to you a doctor Richard Mellor.

Okay, well, thank you operator.

First of all thank you everyone for.

Listening in on the call.

I appreciate your interest and we look forward to our next call on December 12th from New Orleans.

And I hope to give you.

Update there as well as the usual quarterly updates as we move through the end of the year in 2023. Thank you very much.

The conference has now concluded at this time.

Today's presentation.

You may now disconnect.