Good afternoon, and welcome to the Curis Third Quarter Earnings Call. All participants will be in listen-only mode. [Operator Instructions] After today’s presentation, there will be an opportunity to ask questions. [Operator Instructions] Please note this event is being recorded. I would now like to turn the conference over to the Company’s Chief Financial Officer, Bill Steinkrauss. Please go ahead.

Thank you, and welcome to Curis’ third quarter 2019 earnings call. Before we begin, I would encourage everyone to go to the Investors section of our website at www.curis.com to find our third quarter 2019 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, Head of R&D. We will also be available for Q&A at the end of the call. I’d now like to turn the call over to Curis’ CEO, Jim Dentzer.

Thank you, Bill. Good morning, everyone, and thank you for joining us today for our third quarter 2019 earnings call and business update. Our mission at Curis is to develop the next generation of targeted cancer drugs to help patient's live longer, healthier lives. This involves leveraging our translational biology, precision medicine and clinical development expertise to select the right targets, design the right drugs, and then study the right patients. This quarter we've made significant progress across our clinical programs for our novel first in class cancer therapeutics with our fimepinostat and CA-4948 studies enrolling well and on track for data readouts before the end of the year. And so I'd like to begin this call by reviewing the data we announced earlier today from our CA-170 program in mesothelioma. As a reminder, CA-170 is the first oral small molecule targeting VISTA and PDL1 and the only candidate of its kind in the clinic. Earlier today, we announced initial efficacy data from our Phase 1 study of CA-170 in mesothelioma patients with high VISTA expression in conjunction with the Society for Immunotherapy of Cancer 2019 Annual Meeting in National Harbor, Maryland. A quick reminder about the study design. Our Phase 1 study was designed to evaluate the safety, recommended Phase 2 dose and maximum tolerated dose of CA-170. Secondary endpoints of this trial were pharmacokinetic or PK and anticancer activity. Exploratory endpoints included biomarkers and pharmacodynamic or PD effects. The study enrolled 12 patients with mesothelioma across six study sites within the U.S. and UK, randomizing patients into two cohorts. The high dose cohort received 1200 mg twice daily of CA-170, while the low dose cohort received 200 mg twice daily of CA-170. Patients who did not respond or experienced disease progression at the 200 mg twice daily dose…

Thank you, Jim. Hello everyone and thanks for coming and joining us this morning. I'll start with fimepinostat, our anti-MYC program which targets both the genetic transcription and protein degradation of MYC. Fimepinostat uniquely targets MYC through simultaneous inhibition of both PI3-kinase and HDAC, two enzymes that are essential to manifest MYC's derangement in cancer. As you may know, MYC levels are enhanced in many malignancies through a variety of mechanisms. We and others have shown synergy in targeting both HDAC and PI3-kinase simultaneously, but we have the advantage in fimepinostat of targeting both enzymes within the same molecule and we have shown clinically that both enzymes are inhibited. In clinical studies to date, in patients with MYC altered DLBCL fimepinostat is shown at 23% overall response rate and a median duration of response of 13.6 months as a single agent. Many patients received clear benefit even in the double-hit population of DLBCL a patient group with the most challenging prognosis. We decided to combine fimepinostat with venetoclax an anti-lymphoma agent in our Phase 1 study for two main reasons. First, since the strong benefit of fimepinostat is somewhat delayed due to its mechanism of action, adding an anti-lymphoma agent allows us to create a bridge for patients with rapidly growing lymphomas, slowing this growth long enough to allow fimepinostat's benefit to take hold. Second, double-hit lymphoma, one of the deadlier types of lymphoma is defined by alterations in both MYC and BCL-2 since venetoclax is a rapidly acting drug that target ECL2 is combination with our MYC suppressor fimepinostat is we believe an ideal combination to target this type of lymphoma. This has been supported in preclinical models of double hit lymphoma where we've observed dramatic synergy with this combination our. Our Phase 1 study is designed to evaluate…

Thank you, Bob. Now for an update on our financial results. For the third quarter of 2019 we reported a net loss of $6.4 million or $0.19 per basic and diluted share as compared to a net loss of $7.2 million or $0.22 per basic and diluted share the same prior year period. Revenues were $2.9 million for the third quarter of 2019 as compared to $2.8 million for the same period in 2018. Revenues for both periods comprised primarily of royalty revenues recorded on Genentech and Roche's net sales of Erivedge. Operating expenses were $8.2 million for the third quarter of 2019 as compared to $9.3 million for the same period in 2018. Research and development expenses were $5.1 million for the third quarter of 2019 as compared to $5 million for the same period in 2018. The increase was primarily driven by increased costs related to clinical activities for CA-4948. General and administrative expenses were $2.9 million for the third quarter of 2019 as compared to $4.1 million for the same period in 2018. The decrease in general and administrative expenses was driven primarily by lower personnel, legal, and consulting cost during the period. Other expense was $1.1 million for the third quarter of 2019 as compared to $0.8 million for the same period in 2018. For the third quarter 2019 net other expense primarily consisted of imputed interest expense related to future royalty payments, whereas in 2018 the expense related to interest accrued on Curis Royalty's debt obligations. As of September 30, 2019 our cash, cash equivalents and investments totaled $28 million and there were approximately 33.2 million shares of common stock outstanding. We anticipate that our existing cash, cash equivalents and investments should enable us to maintain our planned operations beyond our upcoming data catalysts for fimepinostat and CA-4948 into the second half of 2020. Now I'd like to open the call for questions. Operator?

[Operator Instructions] This concludes our question-and-answer session. I would like to turn the conference back over to the company's President and Chief Executive Officer, James Dentzer for any closing remarks.

Thank you, operator. We made significant progress this quarter and have continued to execute on the goals we laid out for our company at the end of 2018. Although we did not observe single agent efficacy in our CA-170 mesothelioma study, we remain intrigued by the role of VISTA in cancer. We plan to evaluate the translational science and clinical pharmacodynamics of CA-170 as well as the patient data from the Phase 1 study to determine our plan for future clinical development. We also continue to believe that VISTA is an important and scientifically validated target that is worth studying further and will update you on our progress as we seek to address VISTA as a therapeutic approach for difficult to treat cancers. As we turn to the last few months of the year, we're focused on advancing our clinical programs for fimepinostat and CA-4948 and are on track to report data from both programs before year-end. Before we close, I'd like to thank all of the patients and families who participate in our clinical trials, as well as our team at Curis and our partners at Aurigene for their commitment and support. Thank you for joining us on our call today and we look forward to updating everyone again soon.

The conference has now concluded. Thank you for attending today's presentation. You may now disconnect. : :