Curis, Inc.

Good afternoon, and welcome to QRIS's second quarter 2020 earnings call. All participants will be in listen-only mode. Should you need assistance, please signal a conference specialist by pressing the star key followed by zero. After the company's prepared remarks, call participants will have an opportunity to ask questions. To ask a question, you may press star, then one on your touchtone phone. To withdraw your question, please press star, then two. Please note, this event is being recorded. I would now like to turn the conference over to the company's Chief Financial Officer, Bill Steinkraus. Please go ahead.

Thank you, and welcome to QRIS's second quarter 2020 earnings call. Before we begin, I would encourage everyone to go to the investor section of our website at www.qris.com to find our second quarter 2020, Earnings Release, and Related Financial Tables. I would also like to remind everyone that during the call, management will be making forward-looking statements, which are based on our current expectations and beliefs. These statements are subject to certain risks and uncertainties, and actual results may differ materially. For additional details, please see our SEC filings. Joining me on today's call are Jim Dentzer, President and Chief Executive Officer, and Bob Martell, our Head of R&D. We will also be available for a question and answer period at the end of the call. I'd now like to turn the call over to Keras' CEO, Jim Dentzer. Jim?

Thank you, Bill. Good afternoon, everyone, and thank you for joining us today. As many of you know, Our mission at QRIS is to develop the next generation of targeted cancer therapies to meaningfully improve and extend patients' lives. Our novel pipeline is driven by our team's expertise and ability to identify untapped targets in oncology that we believe have significant potential to address unmet patient need. In the second quarter, we executed against both clinical and financial goals making significant progress toward key targets for the year. We advanced dose escalation in our ongoing study of CA4948, our IRAC4 program, in patients with relapsed or refractory non-Hodgkin's lymphoma, or NHL. We initiated a second IRAC4 study in patients with relapsed or refractory acute myeloid leukemia, or AML, and high-risk myelodysplastic syndromes, or MDS. Also in the second quarter, we received FDA clearance to proceed on our investigational new drug application for CI8993, our monoclonal anti-VISTA antibody. Lastly, we also completed a significant financing transaction with several fundamental healthcare investors. It was a very eventful quarter for QRIS, and in aggregate, These accomplishments set us up for exciting data catalysts later this year and continued momentum as we look to 2021. We're moving full steam ahead at QRIS, and I look forward to building on this progress in the third quarter. With that, let's jump into our clinical development programs, starting with our small molecule IRAC4 kinase inhibitor, CA4948. As a reminder, We are currently evaluating CA4948 in an ongoing Phase I dose escalation study for the treatment of patients with relapsed or refractory non-Hodgkin's lymphoma, or NHL, including patients with diffuse large B-cell lymphoma, Waldenstrom's macroglobulinemia, and oncogenic MiD88 mutations. In this Phase I study, we are currently evaluating patients being treated with 300 milligrams twice daily of CA4948, after observing clear dose response and tumor reductions at previous dose levels. The pace of enrollment slowed in the second quarter as many clinical sites temporarily halted enrollment due to the COVID-19 pandemic. Fortunately, following new guidance and protocols, several of our Phase I study sites have reopened and are actively enrolling new patients. So while the data are not yet mature enough for us to declare a recommended phase two dose today, we are confident we will be in a position to provide updated safety and efficacy data as well as finalize the recommended phase two dose by the end of this year. That said, the tumor reduction data we have seen so far are very encouraging. It is with these data in hand that we are excited to announce today our plan to initiate the combination study of CA4948 with ibrutinib, the market-leading BTK inhibitor. In preclinical models, both IRAC4 and BTK inhibition have been shown to provide significant anti-cancer benefit. As one might expect, given their different mechanisms of action, they also appear to be highly synergistic. and our clinical investigators are eager to see if this preclinical efficacy in combination therapy translates to the clinic as well as the single agent efficacy data have. With today's announcement, we are initiating work with our clinical sites and the FDA and expect to begin enrollment in a phase one study of CA4948 in combination with ibrutinib before year end. Now let's move to leukemia. Our study in CA4948 in patients with relapsed or refractory AML and high-risk MDS, including those with spliceosome mutations driving expression of the oncogenic long isoform of IRAC4. Last month, we announced the dosing of the first patient in our open-label Phase I dose escalation study of CA4948 monotherapy in these patient populations. We have been eager to start this study ever since the seminal presentation of Dr. Amit Verma and Dr. Daniel Starzanowski at the ASH conference last year, in which they identified specific spliceosome mutations as drivers of disease by causing the expression of the long isoform of IRAC4. While the short isoform of IRAC4 is normal, they demonstrated that the long isoform is oncogenic. Further, they demonstrated that blocking IRAC4 with a treatment of 4948 dramatically reduced the formation of leukemic blasts. Their work changed the landscape of AML and MDS by identifying IRAC4L as the first and only known driver of disease that affects over half the population of patients with AML and MDS. With the findings of Dr. Herma and Dr. Starzanowski in hand, as well as the preliminary data from our NHL study. We worked quickly with our clinical investigators and the FDA to design a study of CA4948 in the AML and MDS population. And we are pleased to have dosed our first patient just six months later. This phase one dose escalation study is enrolling a minimum of three patients at each dose level starting with 200 milligrams twice daily. As I mentioned earlier, we're excited to be starting this study at a potentially therapeutic dose level following the FDA sign off as 200 milligrams twice daily was determined to be both safe and capable of achieving encouraging biologic activity and clinical efficacy in our phase one NHL study. The primary objective of this study is to determine the maximum tolerated dose and recommended phase two dose of CA4948 based on safety and tolerability, dose limiting toxicities and pharmacokinetic and pharmacodynamic findings. We could not be more excited to have this study underway and we look forward to reporting initial data by the end of this year. Now I'd like to turn to our VISTA program and our first in class Monoclonal anti-VISTA antibody, CI8993. VISTA is a target we're really excited about. When activated, VISTA plays a critical role in suppressing T cell activity. Conversely, blocking VISTA has been shown in preclinical studies to prevent T cell suppression and thereby reactivate anti-tumor immune function. We also see potential in targeting VISTA in combination with a PD-1, PD-L1, or even a CTLA-4 inhibitor, as preclinical studies suggest that blocking VISTA significantly improves the efficacy of those checkpoint regulators. As many of you remember, we previously developed a small molecule that targeted PD-L1 and VISTA. While that small molecule was active, it did not produce efficacy competitive with the monoclonal antibodies in development at that time in our target population. We believe this was probably for two reasons. First, as a large molecule, a monoclonal antibody provides complete coverage of a receptor across multiple binding regions. By comparison, a small molecule interrupts only one or two contact points on a target receptor. Monoclonal antibodies tend to firmly wrap around a receptor almost like Velcro, as opposed to a small molecule, which continually bounces on and off its target. For these reasons, we began a search last year for the best IP, the best library of drug candidates, and the deepest understanding of VISTA biology. In Immunext, we found a partner with all three. and in January of this year, we entered into an option and license agreement with them for the development and commercialization of CI-8993 and went immediately to work on developing it. In June, just five months later, the FDA cleared our IND application for CI-8993, making it the only anti-VISTA antibody currently in development to answer testing in humans. We're pleased with the interest and excitement we've received from the clinical community on this program, and we believe CI8993 has the potential to be a game-changing cancer therapy. We look forward to initiating a phase one study of CI8993 in patients with solid tumors later this year. To wrap up, we're very excited about our clinical progress so far this year. We hope the next few months will bring us even closer to developing meaningful therapies to patients battling cancer. With that, I'll turn the call back over to Bill to review our financial results for the quarter.