Corvus Pharmaceuticals, Inc. (NASDAQ:CRVS) Q1 2024 Earnings Call Transcript May 6, 2024
Corvus Pharmaceuticals, Inc. isn’t one of the 30 most popular stocks among hedge funds at the end of the third quarter (see the details here).
Operator: Good afternoon ladies and gentlemen and welcome to the Corvus Pharmaceuticals’ Business Update and Reports First Quarter 2024 Financial Results Conference Call. At this time, all lines are in a listen-only mode. Following the presentation we will conduct a question-and-answer session. [Operator Instructions] This call is being recorded on Monday, May 06, 2024. I would now like to turn the conference over to Zack Kubow of Real Chemistry. Please go ahead.
Zack Kubow: Thank you, operator and good afternoon everyone. Thanks for joining us for the Corvus Pharmaceuticals’ first quarter 2024 business update and financial results conference call. On the call to discuss the results and business updates are Richard Miller, Chief Executive Officer; Leiv Lea, Chief Financial Officer; Jeff Arcara, Chief Business Officer; Jim 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.
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’ annual report on Form 10-K, and other filings the company makes with the SECTOR 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 Lea. Leiv?
Leiv Lea: Thank you, Zack. I will begin with a quick overview of our first quarter 2024 financials and then turn the call over to Richard for a business update. Research and development expenses in the first quarter of 2024 totaled $4.1 million, compared to $4.6 million for the same period in 2023. The net loss for the first quarter 2024 was $5.7 million, including non-cash income of $0.2 million related to Angel Pharmaceuticals, our partner in China. This compares to a net loss of $7.9 million for the same period in 2023, which included a $1.7 million non-cash loss related to Angel Pharmaceuticals. Total stock compensation expense for the first quarter of 2024 was $0.7 million, compared to $0.5 million for the same period in 2023.
As of March 31, 2024, Corvus had cash, cash equivalents and marketable securities totaling $22.1 million, as compared to $27.1 million at December 31, 2023. Today, we closed a $30.6 million financing that included a premier group of biotech investors as well as some members of the Corvus leadership team. Including the proceeds from this financing pro forma cash at March 31, 2024, was approximately $52.7 million, extending our cash Runway into Q4 of 2025. I will now turn the call over to Richard, who will discuss our clinical progress and elaborate on our strategy and plans.
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Q&A Session
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Richard Miller: Thank you, Leiv and good afternoon everyone. Thank you for joining us today for our business update call. Since our Q4 update in mid-March, we have continued to make progress against two key value drivers that we are focused on for 2024. First for our planned registrational Phase 3 trial of soquelitinib for patients with relapsed peripheral T cell lymphoma, we remain on track to begin enrollment in the third quarter, and our confidence in this trial continues to grow as two additional patients in our Phase 1b trial recently achieved objective responses at first follow up. Second, our placebo controlled Phase 1 trial of soquelitinib for patients with moderate-to-severe atopic dermatitis. We began patient enrollment in April, which keeps us on track to report early data from the trial before the end of the year.
In addition to these two priorities with soquelitinib, today we are reporting encouraging initial data from our Phase 1b/2 trial of Ciforadenant, our adenosine A2A receptor antagonist in frontline metastatic renal cell cancer, or RCC. Based on the significant deep response rate seen in the initial set of patients, the protocol pre-specified statistical criteria for expanding the study has been met and the Kidney Cancer Research Consortium, or KCRC, is enrolling additional patients. Combined with our ongoing business development efforts aimed at further unlocking the potential of ITK inhibition in a broad range of oncology and autoimmune indications, we believe Corvus is positioned to continue building value and advancing our unique pipeline to help improve clinical outcomes for patients.
Now I will provide more detail on our progress, starting with soquelitinib for PTCL. While we are no longer enrolling new patients in our Phase 1 trial, the data continues to evolve as patients on therapy complete their scheduled follow up assessments. In the most recent data cutoff from May 3, 2024, we had two additional patients that achieved an objective response at their first follow up visit. The first was a complete response confirmed by PET CT scan, and the second was a partial response with over 80% tumor volume reduction. These patients both had multiple sites of disease and had failed two prior therapies. Both of these patients are continuing on therapy. With these additional valuable patients, the objective response rate, or ORR for the Phase 3 eligible patients is now nine out of 23 or 39%, including five complete responses and four partial responses.
Although not studied head to head, the complete response rate for soquelitinib at 22% is approximately double that seen with belinostat or pralatrexate, the standard chemotherapies for PTCL that we will be comparing to in our Phase 3 trials. Similarly, the ORR disease control rate, progression free survival, and overall survival for this group compares favorably to the results seen with belinostat or pralatrexate. The median PFS for our patients, which is the primary endpoint for the Phase 3 trial, is 6.2 months. This is substantially better than reported results for the standard agents, which is 1.6 and 3.5 months for belinostat and pralatrexate, respectively. The durability of our responses is impressive with some of the earlier enrolled patients maintaining their responses for more than 24 months.
We plan to begin patient enrollment in our soquelitinib registrational Phase 3 clinical trial in relapsed PTCL in the third quarter of 2024. We are working with or are in advanced discussions with a number of leading centers in the United States and Canada. We anticipate about 40 centers will participate in the trial. The vast majority will be in the United States. Now for an update on soquelitinib for atopic dermatitis, the first immune disease indication we are evaluating. In April, we initiated patient enrollment in the first patient cohort of the trial. There is high interest in our trial from physicians due to several attractive features of soquelitinib. First, this is a first in class drug with a novel mechanism of action. Soquelitinib acts upstream by blocking Th2 and Th17 cells and thereby results in inhibition of many different cytokines involved in disease.
Second, it is an oral therapy and in our cancer studies has been shown to have very good safety profile and third, it may have broad utility across many different autoimmune and inflammatory diseases and this trial may prove provide proof of concept for the treatment of other immune diseases. The trial is designed to enroll 64 patients with moderate to severe atopic dermatitis that have progressed on at least one prior therapy. The study is randomized, placebo controlled and blinded to patients and treating physicians. There will be four sequentially enrolled cohorts of 16 patients, with patients in each cohort being randomized three to one to different dosing regimens of soquelitinib or placebo given for 28 days. The primary endpoint is safety and tolerability and efficacy is measured using investigator global assessments and the clinically validated measurement of improvement in eczema area and severity index score, also known as EASI.
It should be noted that while the trial is double blind, the company is not blinded. We plan to evaluate the data in an ongoing manner as successive cohorts complete enrollment. We also will be measuring the levels of various serum cytokines at baseline and on treatment. These measurements may provide useful biomarkers. Based on current enrollment trends, anticipated site activations, and follow up timelines, we believe data from the initial cohorts will be available before the end of 2024, with study completion in early 2025. Outside of our PTCL and atopic dermatitis trials, we are still planning a soquelitinib solid tumor trial as a single agent and in combination with nivolumab in relapsed RCC, and we remain active with our corporate partnering discussions.
Our business development strategy is to find partners with development and commercialization expertise in immune diseases as well as seek regional partnerships in oncology that would be complementary to our focus and expertise in cancer. I’m excited to update you on the progress with ciforadenant, our adenosine A2A receptor antagonist. We have been one of the leaders in the development of adenosine A2A receptor antagonism for the treatment of cancer. Over the past few years, published preclinical and clinical studies have demonstrated the antitumor activity of ciforadenant as a monotherapy and when given in combination with checkpoint inhibitors. In particular, in our preclinical studies published in 2018, we found that anti-CTLA-4 antibody combination with ciforadenant produces striking antitumor efficacy in several animal models.
Further research has revealed the probable mechanism for this synergy, which involves modulation of the tumor microenvironment, specifically the blocking of myeloid derived suppressor cells. In other words, we believe that anti-CTLA-4 antibodies are a much better combination partner for A2A antagonist than anti-PD-1s. These findings led to our collaboration with the Kidney Cancer Research Consortium. This group of institutions brings the leading physicians and researchers in kidney cancer whose goal it is to discover improved therapies for patients with renal cancer. Our Phase 1b/2 clinical trial, which is led by Dr. Kathy Beckermann from Vanderbilt University Medical Center, is evaluating ciforadenant as a potential first line therapy for metastatic renal cell cancer in combination with ipilimumab and nivolumab.
