Earnings Labs

Corvus Pharmaceuticals, Inc. (CRVS)

Q2 2019 Earnings Call· Sun, Aug 4, 2019

$14.50

-6.79%

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Transcript

Operator

Operator

Good afternoon, ladies and gentlemen. Thank you for standing by, and welcome to the Corvus Pharmaceuticals Second Quarter 2019 Business Update and Financial Results Conference Call. As a reminder, today's conference is being recorded. [Operator Instructions] It is now my pleasure to turn the call over to Zack Kubow of Pure Communications. Please, go ahead.

Zack Kubow

Analyst

Thank you, operator, and good afternoon, everyone. Thanks for joining us for the Corvus Pharmaceuticals second quarter 2019 business update and financial results conference call. On the call to discuss the results and business highlights for the second quarter of 2019 are Richard Miller, Chief Executive Officer; Leiv Lea, Chief Financial Officer; and Mr. Mehrdad Mobasher, Chief Medical Officer. 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' quarterly report on Form 10-Q filed with the SEC today and other filings the company makes with the SEC from time to time. The company undertakes no obligation to publicly update or revise any forward-looking statements, except as required by law.With that, I'd like to turn the call over to Leiv.

Leiv Lea

Analyst

Thank you, Zack. I will begin with a quick overview of our second quarter financials and then turn the call over to Richard, for a business update.At June 30, 2019, Corvus had cash, cash equivalents and marketable securities totaling $96.8 million as compared to $114.6 million at December 31, 2018. Research and development expenses in the second quarter 2019 totaled $10.6 million compared to $9.7 million for the same period in 2018. The increase of $900,000 was primarily due to an increase in CPI-006 program costs. The net loss for the second quarter of 2019 was $13 million compared to a net loss of $11.6 million for the same period in 2018. Total stock compensation expense for the second quarter of 2019 was $1.9 million compared to $1.7 million of total stock compensation expense for the same period in 2018.I would like to note that we continue to carefully manage our expenses and currently expect full year 2019 net cash used in operating activities to be between $38 million and $42 million with a 2019 year-end cash balance between $73 million and $77 million.I will now turn the call over to Richard.

Richard Miller

Analyst

Thank you, Leiv, and good afternoon, everyone. Thank you for joining us today for our second quarter 2019 business update.During the quarter, we continued advancing all three of our clinical programs, highlighted by the presentation of the initial CPI-006, clinical data in an oral presentation at ASCO in June. On today's call, I will provide a recap of the highlights from ASCO, along with an update on our other development programs, including anticipated key milestones for the remainder of 2019. We had a very positive ASCO meeting, reinforcing our position as a leader in the development of the adenosine pathway based therapeutics, and in the development of second-generation immuno-oncology medicines. The initial data from our 006 clinical trial was presented in an oral presentation by Dr. Jason Luke, Principal Investigator of the trial and Director of the Cancer Immunotherapeutic Center at the University of Pittsburgh Medical Center, Hillman Cancer Center. The presentation included data from a total of 20 patients, 12 patients who received CPI-006 given intravenously as monotherapy at doses of 1, 3, 6, 12 milligrams per kilogram every 21 days and 8 patients who received the combination treatment of CPI-006 at 1, 3, 6 milligrams per kilogram every 21 days plus a fixed-dose of ciforadenant, 100 milligrams twice daily. These patients all had advanced refractory disease and had failed a median of four prior therapies.CPI-006 is a novel, first of its kind, anti-CD73 antibody. We created and are developing this antibody because it possesses unique immunomodulatory properties. We are pleased with the results presented at ASCO as they confirm what we set out to create with 006, an immunologically active and very selective antibody targeting CD73. The combination of immune stimulation and adenosine blockade is expected to be synergistic.Let me give a few takeaways from the presentation at…

Operator

Operator

[Operator Instructions] We'll take our first question from Michael Morabito with Credit Suisse.

Michael Morabito

Analyst

I just have two for you. One on CPI-006, I was trying to find out if I heard you correctly, are you still increasing the dose beyond 12 mg per kg in that? And how many new patients should we expect roughly when the data comes on SITC? And also, the OpEx guidance that you gave. You said you saw net 2019 cash use of $38 million to $42 million, but the first half use was already $26 million. So I was just wondering where the savings would be coming from?

Richard Miller

Analyst

Okay. So there's two questions. I'll take the first one. So we have continued to increase the dose of the antibody to now 24 milligrams per kilogram, not yet seen any MTD or DLT dosing toxicity. 24 milligrams per kilogram is the highest dose we're going to test. We know we're super saturating the antigen. And the dose that we'll use for our expansion part of the trial will be lower than 24 milligrams per kilogram. We're still working out the details of our pharmacokinetics and pharmacodynamics, but we're at higher than the dose we expect to use this in the future. And the financial question, Leiv, I'll let you take that one.

Leiv Lea

Analyst

Sure, Mike. So for the first 6 months, our net cash used in operating activities was $18 million, which is a little bit half the $40 million at the midpoint of our full year forecast.

Richard Miller

Analyst

Michael, and also -- sorry, I forgot to answer the second part of your question, how many more patients. You're going to see at least a doubling of the patients.

Operator

Operator

We'll take our next question from Biren Amin with Jefferies.

Unidentified Analyst

Analyst · Jefferies.

This is Jed [ph] on for Biren. Just a couple from me. Could you just reiterate again for the prostate cancer patients that you said you're including in the Phase Ib study, could you just clarify the breakdown of those patients from monotherapy and combo, and when can we potentially expect to see the data on those patients?

Richard Miller

Analyst · Jefferies.

I think we'll probably talk about some of that data at SITC. The breakdown, I don't have those exact numbers off the top of my head, but probably about half of more monotherapy, some of them were combo with Atezo while some are combo of 006 [ph].

Unidentified Analyst

Analyst · Jefferies.

And just a second one for me as well. Just regarding the ciforadenant non-small cell data from the Morpheus ongoing study. I think on the Q1 call, you said that there might be a cut of the data that would be seen around about this time. Is there any update on that, and when can we expect to see some data from that study?

Richard Miller

Analyst · Jefferies.

So I don't have a cut on that data yet. Patients have been enrolled in the study, and they're still under follow-up. We don't control that study, as you know. I would expect that we'll be able to look at that data later this year.

Unidentified Analyst

Analyst · Jefferies.

Okay, got it. And maybe just one more from me, more of a biology one on 818. Is RLK down regulation or lack of expression, a consistent observation that's been seen across human T-cell lymphoma subtypes, or is it observed in more select subtypes? Just looking for a general trend there.

Richard Miller

Analyst · Jefferies.

So first of all, our 818 is an ITK inhibitor, just to be clear, not RKL. But RKL is a very interesting story. The unique feature of our drug is that it inhibits ITK without inhibiting RLK, and that turns out to be biologically crucial and very difficult to do chemically. That's one of the reasons why we get this TH1 skewing. If you block -- this is a long story, but if you block ITK and not RLK, the differentiation of T-cells is such that you'll bias differentiation towards the TH1, which you want in cancer therapy. Now in terms of T-cell lymphoma, specifically, there's very good reason to believe that many, many T-cell lymphomas have over expression of the T-cell receptor signaling pathway, of which ITK is a critical signaling molecule. That was the whole rationale for going after ITK, similar to the rationale we used when we went after BTK in B-cell lymphomas.

Operator

Operator

[Operator Instructions] We'll take our next question from Tony Butler with ROTH Capital.

Unidentified Analyst

Analyst · ROTH Capital.

This is Deb [ph] on for Tony. Just had a quick follow-up for confirmation here. Rich, did you say that for the combo data for CPI-004 and CPI-006, that you're currently at the 24 mg, or is that in the monotherapy cohort?

Richard Miller

Analyst · ROTH Capital.

The monotherapy is at the 24 mg per kg. The combo is just a little bit behind it. The combo is at 18.

Unidentified Analyst

Analyst · ROTH Capital.

18, okay. So you're definitely above the 12 hurdle, then.

Richard Miller

Analyst · ROTH Capital.

Yes.

Unidentified Analyst

Analyst · ROTH Capital.

And then just a quick follow-up. Have you enrolled anyone in the CPI-006 plus KEYTRUDA combo arm?

Richard Miller

Analyst · ROTH Capital.

Not yet. Our plan is to get more data on our own drugs, 006 and 444. And once we get more comfortable with that, then we'll open up the other arm.

Unidentified Analyst

Analyst · ROTH Capital.

Okay. And just to make sure I heard this correctly, did you say that you were positive or leaning more towards CPI-006 plus CPI-444 for the prostate cancer combo, or you're still trying to figure things out versus Atezo or not?

Richard Miller

Analyst · ROTH Capital.

I would say we're still trying to figure things out. We've been extremely encouraged by what we're seeing with 006 and 444, and that has caused us to pay -- to look much more carefully at that combination.

Operator

Operator

We'll take our next question from Robert Driscoll with Wedbush Securities.

Unidentified Analyst

Analyst · Wedbush Securities.

This is Ashwin [ph] on for Robert. I just wanted a quick clarification on the new prostate cancer arm, the Phase Ib/II study. Will you be using the Adenosine Signature to help select for those patients, or will that be more of a retrospective analysis?

Richard Miller

Analyst · Wedbush Securities.

We're going to use it retrospectively for two reasons. One, we need to also get more experience on Adenosine Signature negative as well as positive. And secondly, it really helps enrollment if you allow everyone in. If you require a biopsy and then tell patients you can't go on to the study, they get very irritated. So it makes this study a lot more practical.

Operator

Operator

And that concludes the question-and-answer session. I'd like to turn the call back over to Richard Miller for any additional or closing remarks.

Richard Miller

Analyst

All right. Thank you, operator. First of all, thanks, everyone, for joining us on the call today. I appreciate everybody's interest. Again, let me remind everybody about SITC in November and hopefully, you can attend our presentations, and you can also attend the investor reception that we're hosting. Thank you, operator.

Operator

Operator

Thank you. And that does conclude today's presentation. Thank you for your participation. You may now disconnect.