Q3 2023 Corvus Pharmaceuticals Inc Earnings Call
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Good afternoon, ladies and gentlemen, thank you for standing by and welcome to the Corvus Pharmaceuticals third 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.
It is now my pleasure to turn the call over to your host Zach Kouba I've real chemistry. Please go ahead Sir.
Thank you operator, and good afternoon, everyone.
Thanks for joining us for the Corvus Pharmaceuticals third quarter, 2023 business update and financial results Conference call.
On the call to discuss the results and business updates are Richard Miller, Chief Executive Officer Lately, Chief Financial Officer James.
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 for.
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 course of its quarterly report on Form 10-Q, which was filed today with the SEC.
Their filings the company makes with the SEC from time to time.
The company undertakes no obligation to publicly update or revise any forward looking statement, except as required by law.
With that I'd like to turn the call over to Leif.
Right.
Thank you Zack I'll begin with a quick overview of our third quarter 2023 financials, and then turn the call over to Richard for a business update.
Research and development expenses in the third quarter of 2023 totaled $4 million compared to $10 $4 million for the same period in 2020 to the.
The decrease of $6 $4 million was primarily related to lower clinical trial and manufacturing costs associated with the development of LUPA Dole a man hour Mtc. These 73 antibody.
The net loss for the third quarter, 2023 was $6 million, including a $9 million noncash loss related to Angel pharmaceuticals, our partner in China.
This compares to a net loss of $14 $8 million for the same period in 2022, which included a $2.7 million noncash loss related to Angel pharmaceuticals.
Total stock compensation expense for the third quarter 2023 was <unk> 5 million compared to <unk> 7 million for the same period in 2022.
As of September 30th 2023 quarters had cash cash equivalents in marketable securities totaling $32 $2 million as compared to $42.3 million at December 31, 2022.
Looking forward, we expect full year 2023, net cash used in operating activities to be between 22 million and $23 million, resulting in a projected cash balance of between 27 and $28 million as of December 31 2023.
As stated last quarter, we continue to prudently manage our cash burn rate by focusing on our most promising opportunities and establishing collaborations that help support development of our product candidates.
Based on this trend our current plans and our focus on so call. It that we believe our cash will provide runway into late 'twenty 'twenty four I will now turn the call over to Richard who will discuss our clinical progress and elaborate on our strategy and plans.
Thank you Leif and good afternoon, everyone.
You for joining us today for our business update call. We continue to make remarkable progress in the development of our selective ITK inhibitor. So call. It NIM, which provides a platform opportunity across hematologic cancers solid tumors immune mediated and immune mediated diseases.
Since our last earnings call in early August we have accomplished the following key milestones number one we met with the FDA in an end of phase pre phase II phase III meeting to discuss and review registration plans for so-called witness for the treatment of relapsed peripheral T cell lymphoma.
Or P. T C. L number two in this meeting we obtained alignment and agreement on our plans for a registration phase three trial.
Subsequently a finalized complete protocol has been submitted to FDA and we now have all F. D. A regulatory allowances required for starting the clinical trial number three concurrent with our interactions with FDA, we continued recruitment of leading academic academic sites for the.
Trial, which are now progressing through the usual contract and institutional review board approval processes.
For in terms of our ongoing clinical program, we continued enrollment and follow up of patients in our phase one one b trial of Socal at Nib in T cell lymphoma, with an abstract accepted for poster presentation at the Ash meeting in December.
Number five moving to so politically opportunity in solid tumors, we reached alignment with investigators at the kidney cancer Research consortium on a protocol to evaluate so call. It in the mono therapy in patients with recurrent renal cell cancer that have failed checkpoint inhibitor therapy number.
Six outside of oncology, we published a preprint in bio archive presenting research conducted by an international group of scientists demonstrating robust activity of Socal isn't it in several animal models of immune diseases and a description of a novel mechanism that provides the rationale.
Now for the potential utility of ITK inhibition in multiple inflammatory immune mediated diseases.
And last we continued enrollment in the phase II portion of a phase one b two trial with sypher admins combined with Loopnet and if all the Nab and relapsed renal cell cancer.
I will now provide further details on some of these accomplishments starting with our progress towards our phase three registration clinical trial of so-called at Nib and P. T C L.
Since our update call in early September we have refined the study protocol to incorporate Fda's feedback. We recently finalized the study protocol and submitted it to F. D. A I can confirm that there were no substantial changes from what we proposed in the design of the trial or our registration strategy and plans.
From a regulatory perspective, we are clear to initiate the trial.
<unk> the trial was planned to enroll a total of 150 patients with relapsed P. T. C. L 75 patients per arm that have received one to less than or equal to three prior therapies. The restriction on number of prior therapies is important because it also identifies a immuno competent patients which are those.
With absolute lymphocyte counts above $900.
Patients will be randomized to receive sokol at Nib 200 milligrams, two times of day or the standard of care chemotherapy agents. The standard of care agents will be physician's choice between prowler trucks, eight but windows that or gemcitabine.
The primary endpoint will be progression free survival determined by an independent review Committee secondary end points will include objective response rate and overall survival. The study also will include an interim analysis.
Our trial should support FDA approval of statistical significance was achieved and the study is well conducted.
Concurrent with finalizing the protocol, we have been recruiting investigators for this study.
We have found very strong interest in participating in the study from a number of leading centers in the United States and we are in the process of executing contracts securing IRB approvals and the other other usual steps needed to initiate the study.
The interest from U S sites as exemplified by the quality of centers involved so far and includes memorial Sloan Kettering, Stanford Dana Farber UCSF City of Hope MD Anderson, Fred Hutchinson Cancer Center, and many others.
The high level of interest from U S centers is reducing our needs for utilizing centers outside the U S. We believe the greater participation from U S sites provides several advantages, including greater control over data quality stronger package for regulatory approval in the U S. REIT.
<unk> execution risk and reduce cost.
We anticipate about 40 centers will participate in the trial the vast majority will be in the United States.
We are making good progress on all fronts and anticipate that we can initiate the so-called at in a phase III trial by the second quarter of 2024.
We are also continuing on with our phase <unk> clinical trial in T cell lymphoma, we and collaborators at the Beijing Cancer Center plan to present additional data from the phase one <unk> clinical trial of so-called nib in T cell lymphoma, along with correlated data in a poster presentation at the Ash meeting.
In December.
On a related note there is a growing body of evidence supporting the potential of selective ITK inhibition in oncology.
In July we published our preclinical data on so called Internet that highlight and its potential to enhance antitumor immune response to hematologic and solid tumors and provide a novel approach to cancer immunotherapy in.
In September the independent academic group led by a team from Erasmus University Medical Center in Rotterdam, published a paper confirming and extending the potential of ITK inhibition for the treatment of solid tumors. The preclinical and laboratory results were aligned with our preclinical IND.
Clinical data on social Internet and provide additional evidence confirming the potential of selective ITK inhibition to enhance immune responses to solid tumors.
We remain on track for the initiation of a phase one b two solid tumor clinical trial in relapsed renal cell cancer in early 2024.
I will now pass the call to Dr. Jim Rosenbaum to review recent developments for Socal lit nib and inflammatory and immune diseases.
Thank you Richard.
One of the more remarkable discoveries with our ITK inhibitor platform is that we continue to generate evidence supporting its potential as a novel treatment approach for a multitude of immune mediated diseases.
Last week, we published results and bio archive supporting the potential of ITK inhibition across several preclinical models, including acute asthma, chronic asthma psoriasis pulmonary fibrosis, scleroderma and graft versus host disease.
This paper is available on our website and provides an in depth reviews. The data supporting each of these models.
The key finding is that selective ITK inhibition blocks the production of T cells that are critical in the pathophysiology of many immune me diseases.
We believe that so-called isn't yet and our second and third generation ITK inhibitors get to the root cause of many of these diseases by inhibiting the production of a wide range of inflammatory cytokines produced by these shelves.
More specifically.
The mechanism of action described in our paper involves the blockade of th two and th 17 cell differentiation.
And the subsequent inhibition of their production of cytokines, such as interleukin four IL five IL 13, and IL 17.
These are the same cytokines targeted by a range of established successful medicines, they cut across medical categories and indications.
So called <unk> and ITK inhibition provide a small molecule orally administered targeted approach with a novel mechanism that works upstream to block the production of multiple inflammatory mediators.
At the same time, so cool and hip spares th one cells play a vital role in responding to infection.
As a consequence opportunistic infection has not been observed to date in our lymphoma trial treating patients with a compromised immune system.
As noted previously.
The activity of Socal Edison and our other second and third generation compounds are amplified by blocking the T cells responsible for protection of multiple mediators.
Contrast, this with the administration of a soluble receptor or antibody that blocks a single cytokine.
This is a stoichiometric are one to one relationship as opposed to blocking the source of multiple cytokines production.
I encourage you to review the paper.
And our accompanying press release for details.
I will now turn the call back to Richard.
Yeah.
Thanks, Jim.
Given the broad potential of ITK inhibition in inflammatory and immune mediated diseases, we plan to partner with biotech or pharma companies that have established development and commercialization capabilities that match up with the various opportunities.
We believe we are in a strong position to attract partners given the unique features of ITK inhibition human safety data with so-called letting them from our lymphoma work, a large and diverse market opportunities and our strong intellectual property position.
We will continue to focus on cancer, where we have expertise and a track record of success.
Turning to our partner led programs the kidney cancer Research consortium is currently enrolling patients in a phase II portion of a phase one b two clinical trial evaluating sypher, adding into our adenosine <unk> receptor inhibitor as a potential first line therapy for metastatic renal cell cancer in combination.
Whether it be aluminum mad and Navona map.
The clinical trial is expected to enroll up to 60 patients and based on current time lines. We anticipate initial interim data in early 2024.
At this time I am pleased to report that the deep response rate exceeds our 32% benchmark based on eight evaluable patients that have received at least one follow up assessment.
Recall deep response rate is complete responses plus partial responses that exceed 50% tumor volume reduction.
This endpoint has been shown by others to predict prolonged progression free survival and is 32% with the <unk> combination.
For a move of Dolan Mab or partner Angel Pharmaceuticals is continuing to enroll patients in our phase one <unk> clinical trial in China with move until when they are alone and together with timber listen mab in patients with non small cell lung cancer, and head and neck squamous cell cancers.
Taken altogether, we have many opportunities with multiple upcoming catalysts across our pipeline led by our foundational work on I ITK inhibition and its myriad of biologic activities in the immune system.
Over the remainder of the year and into 2020 for our upcoming milestones include new interim data from the phase one <unk> clinical trial of so-called Nib in T cell lymphoma at the Ash meeting in December the initiation of Socal Lytton in phase III registration clinical trial by the second quarter of 2024.
The initiation of a phase one b two solid tumor mono therapy trial of Socal isn't it in relapsed renal cell cancer in early 2024, and initial interim data from the CIT for Adnan Phase <unk> two trial in frontline metastatic RCC in early 2024.
Let me summarize a few points.
Corvus has a pipeline of novel products that address large markets in diverse areas of cancer and immune diseases.
We are advancing along the clinical development pathway with one indication about to enter a phase III registration trial.
We have prudently managed our cash while effectively advancing our products.
The breadth of indications and products provides potential partnering opportunities.
In closing, we look forward to providing updates on our programs in the coming quarters.
I will now turn the call over to the operator for questions and answer.
Thank you at this time, we'll be conducting a question and answer session. If you'd like to ask a question. Please press star one on your telephone keypad.
A confirmation tone will indicate your line is in the question queue.
You May press star two if you'd like to remove your question from the queue.
For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys, one moment, please while we poll for questions.
Our first question comes from Ed and whose enough with Ladenburg. Please proceed with your question.
Hi, good afternoon, Richard and Corvus team, congratulations, but the quarterly results and the progress.
I have a couple of questions.
So regarding the upcoming Ash conference next.
Next month, well could you give us a flavor of kind of data. We expect that we should expect there I think previously corporates reported.
43% or Ars six hour 14 responses and disease control rate, 86%, but how many more patients are.
Data or how many more patient data are you planning to report at Ash and do you expect the or our numbers to change in either direction.
Is that the first question the second question.
It's okay.
Question. So the first question what are we going to present the ash meeting.
So the poster the abstract and the poster was submitted in collaboration with our colleagues at Peking University, Beijing Cancer Center, and what what they focus mostly on our a single cell RNA sequencing to elaborate on the mechanism of action of so-called letting it and they've been key.
And firming on various biopsy and blood samples that indeed, we do induce these th one cells and block th two in th 17, which leads to more side a lot of T cells more or less things that you've heard before.
In parallel with that Corvus intends to issue in its press release and an update on the clinical data now there'll be a couple of things that we're gonna included in that update one is ah patients a number of responses stable disease and durations waterfalls swimmers we also because we.
I had questions on this absolute lymphocyte count versus using prior therapies to identify a suitable candidates or eligibility candidates for our phase III trial. So we'll be showing data on that so I don't expect a substantial change in in response.
We do have more follow up I think that more or less our response rate and durability.
City of responses are are consistent and holding up.
Oh. Thank you. Thank you. So this is helpful and the.
Previously reported she ours are N P or are they still ongoing.
I believe there's not really been a change in the duration of those I'd say the CR is definitely still ongoing down positive us.
And that's out now at all.
Oh, 21 months or so and I just cant off the top of my head I can't really recollect up here you know the duration on those other patients.
Okay understood Alright, and then another question I mean, let me in let me just let me just say the durability of the durability is is very good on our responses and I think that you are putting your finger on a really important point.
Point, because the standard therapies has been notable in that they have had very short durations of disease control.
Yeah.
Right right. Yes. This is helpful.
So another question I have is on Socal isn't it a renal cancer monotherapy trial design.
So obviously, the expectation or or any mono therapies that have or are so what do you think is the sort of minimum threshold for or are in the renal cancer can we expect a similar types of responses as we saw in P. T. C. L or do you think this is a is a little bit it's a different.
Type of cancer and the threshold is different here.
Well I think that's a difficult question to answer without knowing exactly what kind of patients are coming into the study. So eligibility is you have to have failed a checkpoint inhibitor.
And we're allowing a one or two prior therapies. So a lot will depend on the patient selection, but I would say aiding any responses in a relapsed patient.
Relapsed patient following a Cta law for PD, one would be notable I would I would say hey, if you saw 15% response rates a mono therapy in that setting with a novel mechanism of action oral drug that's quite well tolerated I think that would be a big breakthrough I mean ultimately the drug.
The drug of course would be evaluated in combinations, but this is a novel mechanism of action. So I'd say, it's a little bit difficult to say, what my threshold would be I would say, 10%, 20% you'd have yourself a very interesting molecule.
Right Yeah. It makes sense makes sense, okay, alright, thanks, so much for taking the questions and congratulations for the progress. Thank you Amy.
Our next question is from Jeff Jones with Oppenheimer. Please proceed with your question.
Good afternoon, guys and thanks for taking the question.
Richard just a quick question on that asked related press release for the updated data in stack going to be do you have sort of a feel for timing on when that announcement will come out and then in terms of the data itself.
Yeah, we are.
As <unk> had mentioned the you've previously shown in or around 43%.
At or around 40% and you know theres.
There's an abstract at ash with the similar or are so I guess.
Similar to what was just asked on the RCC. How are you thinking about the efficacy bar for Socal, I'll, let Ned and T. T C L.
So.
Adding to the timing of the announcement, we will put that out concomitant with the disc.
Disclosure of the poster so.
Around what is asked December 9th or so around that date.
Regarding that.
The data I think the data is pretty consistent now you asked what do I consider a good response I consider anything above 25% again with durability and safety of oral drug to be too.
To be a good a good outcome.
Okay, No I appreciate that and then on partnering.
As you discussed in your prepared remarks.
Would just be limited to so call at Nab in the autoimmune and planning vacations or would you also consider oncology partnerships for quality.
Our other program Cingal and oncology, perhaps by territory.
I think what we're thinking now Jeff.
Is that.
The inflammation immune disease represents a good partnering opportunity because we have a series of backup molecules that are pretty close to the clinic. We know they work in animal models. They have desirable pharmaceutical properties. There are separate from the oncology molecule which are.
A lot of people want and it's such a novel approach.
And potentially advantageous over the other approaches as Doctor Rosenblatt mentioned and I think we have a really strong intellectual property position.
And we're already getting a significant inbound interest on partnering the immunology part of it the immune disease part of it now we like that because.
Our our expertise is cancer and.
Autoimmune disease is.
As you know there are many different types of autoimmune disease crosses disciplines like pulmonary medicine in dermatology and rheumatology et cetera. So we think.
Our company at our stage with our resources partnering immune disease.
Aspects. It makes the most sense and allows us to continue to focus on T cell lymphoma, and and solid tumors.
So that's sort of our strategy now now things could change obviously, depending on the interest of of our partners and and and so forth.
Does that answer your question.
Yes, no I appreciate it thanks, Richard and I'll jump back into queue.
Our next question is from Roger song with Jefferies. Please proceed with your question.
Great. Thanks for the update and Dicamba question maybe.
Maybe a quick one mm two quick question. So one is.
Rich you said you will start a phase III P. T C. L trial in second quarter next year.
Maybe just.
Just help us to understand what's left before the initiation and I think when you talk about the IRB approval any other like just yet kind of steps you need to compete and the other thing is another.
Another quick question is regarding the wrong way and the funding you know your runway is towards the <unk>.
Later part of the 'twenty 'twenty four while you're starting phase III.
How should we think about the funding of the phase III. Thank you.
Okay. Thanks, Roger the first the answer to the first part the first question is.
From a regulatory perspective protocol.
All of that sort of stuff everything is complete.
The the reason it takes a few months to complete protocols to get through IRB is most institutions now we have not happy that our research committee. So that's just the paperwork is getting through.
These centers were not anticipating any problem.
Most of these institutions now will not evaluate they will not consider a study unless it has been are.
Gone through the FDA approval process and we've done that.
So really there's no there's really no no hurdles with respect to getting this study going.
And as I mentioned, we have had a.
Very good response to our people who want to be involved in the study really the best people in the country.
And I'll, let a leaf answered the second question.
So Roger.
We're going to need to raise additional capital.
However, we're very excited about the broad potential of Cisco.
And then in both oncology and inflammatory and immune mediated diseases.
As Richard mentioned, it opens up partnering opportunities for us.
We believe our pipeline of novel products that address large markets in diverse areas of cancer and immune disease will enable us to finance Corvus, that's a benefit both the company and its.
Stockholders.
So.
We like we like our product candidates are very excited about.
And Oh, we will finance the company.
Yeah as appropriate to benefit both the company and our stockholders.
Yeah that makes sense, thanks for taking the question.
Alright.
I think I don't see any more questions.
So I want to thank everyone for participating in the call. We look forward to updating you on our future progress. Thanks, everyone.
This concludes today's conference you may disconnect your lines at this time and we thank you for your participation.
Okay.
Okay.
Okay off.
Okay.