Q2 2020 Corvus Pharmaceuticals Inc Earnings Call
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Thank you for standing by this is the conference operator, welcome to the Corvus Pharmaceuticals second quarter, Twentytwenty business update and financial results webcast conference call.
As a reminder, all participants are in listen only mode and the conference is being recorded.
After the presentation, there will be an opportunity to ask a question to join the question Q You May Press Star then one on your telephone keypad should we need assistance during the conference call you may signal, an operator by pressing star and zero I.
I would now like to turn the conference over to Zack Kubow Pure Communications. Please go ahead.
Thank you operator, and good afternoon, everyone. Thanks for joining us for the Corbis Pharmaceuticals second quarter 2020 business update and financial results Conference call.
On the call to discuss the results and business highlights for the second quarter 2020, arbitrage Miller, Chief Executive Officer, Lifeway, Chief Financial Officer, and Mehrdad, well Basher Chief Medical Officer.
The executive team will open the call with some prepared remarks, followed by 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 before this is quarterly report on form 10-Q, which was filed today and what the FCC.
Well, the FTC and other filings the company makes with the FCC 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 Lifeway right.
Thank you that I'll begin with a quick overview of our second quarter 2020 financial and then turn the call over to Richard for a business update.
At June Thirtyth, 2020, corridors that cash cash equivalence in marketable securities totaling $59.3 million as compared to $78 million at December 31st 2019.
Research and development expenses in the second quarter, 2020 totaled $7.9 million compared to $10.6 million for the same period in 2019.
The decrease of $2.7 million was primarily due to a point 5 million decrease insofar data clinical trial expenses.
1.7 million dollar decrease in Cpis 006 drug manufacturing costs.
Good point 5 million decrease in C. P 818 drug manufacturing costs.
And in point 8 million dollar decrease in outside service costs.
This was partially offset by a 1.1 million dollar increase since Cpis 006 clinical trial expenses.
The net loss for the second quarter, 2020 was $10.6 million compared to a net loss of 13 point Onemillion for the same period in 2019.
Total stock compensation expense for the second quarter, 2020 was $1.4 million compared to $1.9 million for the same period in 2019.
Looking forward, we expect net cash used in operating activities for the second half were 2020 to be between 12 million in $14 million a reduction from 18.8 million of net cash used in operating activities in the first half a 2020.
This reduction is mainly due to careful management of expenses combined with.
Strong prior enrollment in our clinical studies and the focus on patient monitoring a follow up in these studies.
Our current forecast also includes the incremental activity related to our phase one study of C. P. <unk> 006, and cobot 19, which is relatively less costly than our core oncology programs.
I'll now turn the call over to Richard.
Thank you ladies and good afternoon, everyone. Thank you for joining us today for our second quarter 2020 business update.
We made good progress in the second quarter advancing our pipeline of precise we've targeted oncology therapies and working to initiate a policy clinical program for a novel immunotherapy approach for patients with coated 19.
Corpus now has four Baptist programs in the corner all of which are uniquely positioned in are expected to have meaningful updates in the second half of the or.
It is an exciting time for corbis I want to thank our entire team for the excellent work and dedication that brought us to this point in spite of the challenges created by Covidien team.
Overall, we are fortunate that cold at 19 pandemic has had minimal impact on the company's progress with our core oncology programs our activity in Q2 and into the second half of the year has been focused primarily on patient monitoring and planning for subsequent trials.
Hi, enrollees in our trials enabled us to treat patients and acquired unnecessary data prior to disruption caused by coated.
This enabled us to remain on track with updated suffer I've Newsday didnt renal cell cancer presented at ASCO and no significant interruptions for patients enrolled in our clinical studies.
Moreover, as we recently announced we have filed and R&D and initiated a clinical trial.
Forgetting RCB I 006, B cell activating antibody in Cobiz 19. This study is proceeding as planned.
Looking forward, we will work closely with our investigators to advance our studies with additional data updates expected later this year, we will do this while continuing to prioritize the health and safety of our employees clinical partners in the patients they serve.
Also in support of our studies, we have been in regular communication with our manufacturing partners and there's currently no significant impact on our drug supply.
Turning to an update on our programs starting with it for accident, our small molecule inhibitor of the Denver seem to a receptor.
At the end of May we presented updated clinical data from the phase one of the two clinical trial, that's if radnet in patients with advanced refractory renal cell carcinoma or RCC as part of the ASCO 20 virtual scientific program.
The ASCO data confirms and builds on the suffer Robbins study published in cancer Discovery in January 2020 that highlighted the discovery and potential of the adenosine gene signature a novel biomarker discovery by quarter. This to identify patients likely to response to treatment.
With that for Adnan.
The data, which covered 51 patients demonstrated a 17% overall response rate by resist criteria will sit for Radnet in 30, a valuable patients identified by the adenosine gene signature.
In addition to the five partial responses reported in the 72% response rate there were six additional patients that had tumor regression not meeting the criteria for PR.
These 30 patients had a median of three prior therapies, including 86% that failed prior anti PD one therapy.
Among the remaining 21 patients in the adenosine signature negative group there were no responses.
We also continue to work on refining the predictive value of our biomarker and ignore our overall response rate of 26.7% was reported at ASCO utilizing the CD 68 marker presence on myeloid cells.
Yeah, ASCO presentation was consistent with previous data confirming the anti tumor activity. That's it for radnet in RCC in heavily pre treated patients and continues to support the value of the adenosine signature as a biomarker that can be used to predict patients most likely to respond to treatment with.
Sypher Adnan.
We plan to meet with Ft, a in the fourth quarter of this year to discuss this study design and plans for assist Radnets randomized pivotal study in second third or later line renal cell cancer, usually the refineries adenosine gene signature biomarker.
We will also be exploring the potential for a single arm study based on the adenosine signature since this group of pages does vary quarterly with standard therapies, such as Io agents and Teekay eyes.
As a reminder, the signature identifies a very on favorable group of patients a new subset of RCC and we believe a positive biomarker identified patient group will do well with sit for additive and do poorly with standard therapies, providing upon potential option in an area up on.
<unk>.
Moving to Cpis 006, our VSOE activating anti Cdseventy, three antibody and starting with our oncology program.
In total we haven't rolled over 90 patients to date in this study, which is evaluating cpis 006 alone in combination with sypher admins in combination with Pembrolizumab and a tripling it will sit for radnet temporal isn't that.
We have completed enrollment in the first three groups and continue to enroll in the triplet combination arm, we remain on track to present an update on this work later this year.
Shifting outside of oncology, we're also making good progress with patient enrollment in our phase one dose escalation study of Cpis 006 included 19 patients.
We believe Cpis 006 has the potential to be a novel immuno therapy for the treatment of code at 19.
Its mechanism of action is unlike any other therapies. These studies for covert 19 that we're aware of.
Simulating the body's adaptive immune response to increased levels of anti Sars CODI to antibodies and memory T cells.
This could benefit patients by reducing the severity and duration of their infection and potentially enhancing long term immunity to repeat infection.
Successful, we believe Cpis 006 will be an important option for a range of coated 19 patients beyond the initial study group with mild to moderate symptoms.
And our clinical trial may provide proof of concept for use in future outbreaks of the current or related strain of Corona virus is where other viruses.
We initiated this study at the beginning of July and plan to enroll up to 30 hospitalized patients in four core cohorts receiving a single dose of 0.31 0.03 0.0 were 5.0 milligrams per kilogram.
Patients will receive standard care for covert 19 for the duration of the study.
The primary efficacy endpoint is the change in serum immunoglobulins, ITM and IGBT anti Sars koby to titers at day 28 compared to baseline.
We will also follow antibody levels for six months to assess effects on long term immunity.
The study will also examine safety and other clinical endpoints, including time to resolution of systems clearance, a virus five PCR and duration of hospitalization.
As of today.
We have enrolled four of five patients in the second cohort of the study.
In fact, just a few minutes ago I heard we enrolled the issue at a five in our second cohort. So in total now we have enrolled 10 patients.
To date, we have seen no toxicities and early anti Sars CODI. Two antibody response data is very encouraging with relatively high titers of IDN and I GE to both spike and receptor binding domain viral proteins observed.
In the first two patients tested at the lowest dose of Cpis 006.
We find day seven I GE titers, despite protein of greater than one for 25000 and greater than one for 50000.
One of these patients has completed day 14 testing and shows the tires to both viral spike protein and our BD increased to over 100000 greater than 100000.
These are very high titers, especially at such early time points.
Significant levels of ITM antibodies were also detected.
We will be tracking these patients overtime to evaluate the duration of immunity and the effects on memory be itself.
Based on our progress to date and current trends. We believe we remain on track to quickly enroll the study and report 28 day follow up data on antibody titers for patients sometime in the later part of this year, possibly at 50 in November which now has sessions devoted.
To cope with my team.
If the study meets its objectives cordless intends to work with after you to conduct a double blind placebo controlled randomized pivotal study to support a regulatory submission for FTC approval.
Our plans include evaluating Cpis there there was six in both the outpatient and inpatient setting.
Outpatient treatments are great interest as this group of patients, it's becoming an increasingly part of the code at 19 pandemic.
Lastly on 50.
8.8, or I Teekay inhibitor, we have completed enrollment in the dose escalation portion of the phase. One wanted me clinical trial, which included patients with several types of advanced refractory T cell lymphomas.
The results included a confirmed and durable complete response in one patient with peripheral T cell lymphoma, who previously sale chemotherapy and high dose chemotherapy, followed by autologous bone marrow transplantation.
We have selected the CP <unk> 818, optimum dose and are enrolling patients in the next portion of the study with a focus on patients with PTCL peripheral T cell lymphoma, and cutaneous T cell lymphoma.
This now positions us well for future studies, not only in lymphoma, but also in auto immune diseases.
We plan to provide a data on C. P. Eight when I look for T cell lymphomas at the Ash meeting in December.
In summary, we continue to make good progress with our pipeline and the second half of the year is expected to include important updates for all of our programs. The key milestones in the second half include our after the meeting to discuss a pivotal biomarker driven study for sit for right now.
Thanks in RCC, which could be initiated early next year updated data for Cpis 006.
In CPR 818 at upcoming oncology meeting and the continued enrollment and data read outs from our phase one study of O six four Cobiz 19.
We look forward to updating you on our progress later this year I will now turn the call over to the operator for today operator.
Certainly.
Well now begin the question answer session to join question can you May Press Star then one on your telephone keypad, you will hear a tone acknowledging your request. If you are using a speakerphone. Please pick up your handset afore pressing any keith.
Draw. Your question. Please press Star then too.
Well, we'll pause from women as colors join the queue.
Our first question comes from Merrill Goldstein with Mizuho. Please go ahead.
Your name.
Hello Hello.
Hi, I heard your email me.
Yes, I think.
Hey.
Give us just a little bit more detail around the p. since you have the yard and E. One eight trial and what the trial will look like in CTG, Seattle will it be consistent with what you saw pretty peach yeah cohort.
Color around the peripheral T cell lymphoma patients pretty straight forward a paid yeah with a wider spreads when sat and obviously that had failed chop chemotherapy, which is a routine therapy for PTCL. A then she went on to get high dose chemotherapy.
No.
Bone marrow transplant. She failed shortly thereafter shed growing disease. When she came on our trial. She was on our trial receiving 8.81 pill twice a day.
And was honored for several months and slowly over time had complete resolution of a we've had not that the documented on C.T. scan and on pet scan and confirmed on follow up scams.
A CR by resist criteria or anyone from a criteria you want to use.
And in terms of subsequent studies, we're going to enroll more PTCL and CTCL patients to.
Get more just get more numbers on on those two subsets. Those are the two to the most common subsets of T cell lymphoma, they're very different P. T cells and more rapidly aggressive tumor CTCL was more chronic want to get a little bit more data on on those two we have seen in CTCL responses.
Not quite yet meeting in our dose escalation not quite meeting.
Resist criteria, yet or cesarean criteria.
Our lugano criteria, but very close and we're continuing to follow those patients and we're going to explore those efficacy signals a further in the subsequent patients.
And let's see what was the rest of your question.
I I think I wasn't really respect that but if I go. Okay. That's just on that on the RCC trial in that kind of seen gene signature you know, what though well I suppose the of possible outcomes would be in terms of how you would use adenosine signature you know a poster discussion with FDA. So we think about you know.
It will all come on you, but just have different you know I'm a stratification categories based on that or where are you are you speaking to be able to enroll patients are based on identity signature.
I'll, let dr. mode, Basher, who has been doing a lot of work on that answer that question.
Murdoch right sure, Yes, hi, that's what the current thinking is that for the phase three will enroll all comer patients.
But we will have that Dennis in signature status IDE study enrollment and patients will be stratified based on the signature. However, this study will be powered based on Denison signature positive population and we'll have to truly people didnt negative population.
I will give us a lot of information about the negative population and also help us and further understanding off the signature and by the Biomarkers.
Alright, Thank you I appreciate it.
Sure.
Our next question comes from Tony Butler with Roth Capital Partners. Please go ahead.
[noise] Richard Dog three questions really if if you were to do a trial within eight to a receptor antagonist today that was not in RCC.
Would you still use Dennis seats signature as a more as a biomarker.
Or is it.
Does it pertains more to RCC trial with a two way receptor antagonists. That's question one.
Second question is with all six and given the three cohorts have been have completed dosing and are being monitored could you give us some thought as to what might be demonstrated.
Later this year.
When you do present, some data would be from all four cohorts that isn't won't just be <unk>.
No well, we'd be able to make a distinction between one of the four cohorts <unk> or maybe two versus the other one or two that's the the <unk>. The second question. The third question is.
In funding Oh, six for cold. It is there a mechanism behind which either DARPA can help you with some of that funding or would you just take it on your entire all by yourself. Thank you.
Okay well.
Well this is a test if my memory, Tony So I'll try to try to answer all three questions. So the first question is yes.
The second question is combo and the third question is yes, no seriously Oh, the Oh yeah.
The answer to your first question is yes, we would use the adenosine signature in other tumors. The adenosine signature is present in many other tumors, albeit to a different degrees. We definitely would would explore that in other solid tumors I don't know if I would restrict enrollment.
Based yet on that because we just don't have enough information on the predictive value of the Denison signature and other tumors, but it's definitely something to look at so if we so basically any patient I would say.
Alert here any body using an adenosine.
Mediator blocking agent for anything.
Would be why is to look at the adenosine signature.
Including a CD 73.
So, yes, we would use it but its role in other tumors is not as well understood as we have it for renal cell cancer renal cell cancer, clearly I mean, you don't need any statistics for this you have you know.
Approximately 20% good responses versus zero.
Now in your second question on the O six we've looked at monotherapy, if we looked at combo with fit for adding that we've looked at combo with Pembro and we've looked at triplet combinations look better.
And the triplet is looking very interesting, but I think that's all I can say now theres. Another component to this which is also interesting remember now we've looked at all different kinds of cancers and the each of these individual arms is not powered too.
No show that one is better than the other there's just not enough patients in there.
Multiple different cancer Histologies.
But I think something that's going to be very interesting in the cancer story is the induction of antibodies to certain tumors and the role that induced antibodies might have in a in.
Tumor response now the third question was covert 19 in exploring.
Government funding.
Applications, we are looking at that.
We are we are in have prepared certain applications.
But at the moment, we need to get more data. This is a completely new area. Our plan is to get more clinical data more safety data or the antibody data we're getting in vivo was quite interesting concomitant with that we have some absolutely fabulous stuff happening in the in vitro in other words you can.
You can.
Modulator, a b cells and antibody responses, even in vitro I'm, hoping that we have a very nice presentation on all of that together at the 60 meeting in November but the biology here is quite interesting remember my team at a.
For this.
As some knowledge of B cells, having worked on a couple of drugs you may have heard of Rituxan I've written it and now over six.
And Richard if I may and thank you for that I appreciate the explanation but.
If we go back to the goal six combinations in oncology.
The reason I ask is because there might be Oh for example, p. didn't want if you're doing refractory patients, which work <unk> PD one clear we may not work and a number of dose cohorts and then therefore, they could be a number of patients were refractory to PD. One yet you may now.
Actually have better outcomes, perhaps and one combination or in the trip. What then you may have in the other combination and that's really where I'm trying to drive. This question. If you will yeah.
Yes, so why don't I mean, I know, what you're asking can you take a PD one refractory tumor like colon cancer, something suddenly make it responsive.
I mean, I don't know, we're going to have that kind of information, but I I get where you're going.
So it may be in non small cell lung cancer.
Four or are you could take a PD one response of tumor that failed or something like that and and restore responsiveness.
I mean that seems to be the case with renal cell.
I mean, the conclusion you can drawn Reno as you take a PD one failure and we see we see both kinds of patients we see patients who.
Who are truly refractory to PD, one that as they grow right through a PD one and then we give them.
A combination and they respond we also see people who respond to a PD. One then sale and then you recapture it later when you put it together.
So and those can be very different mechanisms.
As you know.
Thanks, very much for the call.
Thank you for the questions.
I think as any other questions I see another question up there.
Once again, if you have a question. Please press Star then one.
We have one more question from our 30 with H.C. Wainwright. Please go ahead.
Hey, good afternoon, everyone can go to the army.
Yes.
Oh, Thanks for taking my question.
So I have to so first regarding the RCC two of the study design I just wanted to clarify Oh, you guys tend to use the original it didn't know seen signature your proposed and the biomarker or you are also being used to the CD <unk>.
A pause as a biomarker.
Did you guys clarify for that.
And the second one is the Guardian.
Huh.
The second ways regarding to Steve I always seek seem that Colby. This study I just curious have you guys has.
Valuate, the neutralizing antibody titer.
Yeah, Okay. So let me take those questions. The first one on the signature so.
We did a lot of work on the signature and it's going to be some combination of what you as discussed in other words you can incorporate all those into the same kind of gene signature.
So we've we've continue to refine that a little bit in and.
We're still looking at that but basically it's focused on these are these genes that are expressed in myeloid cells, including those 16 City 60 itself now the second question on neutralizing antibodies.
Yes, these patients are making anti neutralizing antibodies.
I mentioned in my.
And my.
Paul and Paul we just had.
That this day 14 patients had a NCR BD of greater than 100000, when you have a tighter of greater than 100000 to the receptor binding domain I guarantee you will have very high neutralization. There's all the studies are showing very close correlation with anti R. BD and neutralisation.
I mean, eventually we people do know neutralization, because it's a it's a much more difficult assay and the RV d. as much much simpler, but the correlation is very good but we get titers of 100000 to our BD. That's for sure are gonna be neutralized.
Great. Thank your for that.
Okay. This.
[noise]. This concludes the question and answer session I would like to turn the conference back over to management for any closing or Mike.
Well. Thank you everyone for for attending the conference call I'm of course, we look forward to providing a more updates on all the programs or as the year progressive thanks very much.
This concludes today's conference call you may disconnect. Your lines. Thank you for participating and have a pleasant day.
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