Good afternoon everyone, and welcome to Curis' First Quarter 2020 Earnings Call. All participants will be in a listen-only mode. [Operator Instructions] After the company’s prepared remarks, all participants will have an opportunity to ask questions. [Operator Instructions] Please note today's event is being recorded.

At this time, I'd like to turn the conference call over to the company's Chief Financial Officer, Bill Steinkrauss. Sir, please go ahead..

Thank you. And welcome to Curis' first quarter 2020 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 first 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, 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.

Jim?.

Thank you, Bill. Good afternoon everyone and thank you for joining us today. Before we recap the quarter, I'd like to make a few general comments about the COVID-19 situation and its impact on our work both internally and with respect to our ongoing clinical studies.

As we speak, along with the rest of the world to adapt to the new rules of life under this pandemic, we remain steadfastly committed to our mission of bringing innovative targeted cancer therapeutics to patients still very much in need.

Our team has responded to challenges stemming from the pandemic with resiliency and dedication, and I'm very proud of the strength of our organization. We continue to monitor institutional, regional and national guidance, so we can remain flexible and abreast of new developments as they arrive.

We are fortunate to be able to productively and efficiently advance our business, while adhering to public health guidelines and working remotely.

On the clinical side, we are working closely with our partners, CROs, manufacturers and study investigators and staff at each of our clinical sites to protect patient's health and safety and ensure they receive uninterrupted access to study drug in a manner that preserves the integrity and rigor of our clinical trials.

With that, I'd like to review our clinical development program. Let's start with our IRAK4 program with CA-4948.

As a reminder, we are currently evaluating CA-4948, an IRAK4 kinase inhibitor in an ongoing Phase 1 dose escalation study for the treatment of patients with relapsed or refractory non-Hodgkin's lymphoma, including patients with diffuse large B-cell lymphoma Waldenström's macroglobulinemia and Oncogenic MYD88 mutation.

While the pace of enrollment has slowed as certain sites have temporarily halted enrollment due to the pandemic, several of our Phase 1 study sites remain open and are recruiting new patients.

At the moment, we are evaluating patients being treated with 300 milligrams twice daily after observing clear dose response and tumor reductions at previous dose levels. We are pleased with the results from the study so far and we remain on track to provide updated safety and efficacy data and declare the recommended Phase 2 dose later this year.

I'd also like to touch on our second program for CA-4948 in patients with acute myeloid leukemia or AML and myelodysplastic syndrome or MDS. The AML and MDS community was excited by the groundbreaking presentation by Dr.

Amit Verma of Einstein at the ASH Conference in December in which he highlighted the role of specific spliceosome mutations as key drivers of IRAK4-L expression.

Further, he identified IRAK4-L, the oncogenic long isoform of IRAK4 as the first and to-date only known driver of disease that affects over half of the population of patients with AML and MDS. We've provided CA-4948 to Dr.

Verma to explore in his lab, and in preclinical studies he found that blocking this long isoform of IRAK4 with the treatment of CA-4948 was shown to dramatically reduce the formation of leukemic block. These preclinical data demonstrated for the first time a clear genetic driver of disease affecting the majority of the AML and MDS patient population.

It is also uniquely exciting for Curis, given that our drug directly target this oncogenic kinase IRAK4-L. We are currently working with our clinical sites and investigators to initiate a Phase I study of CA-4948 in AML and MDS patients.

While the coronavirus pandemic has certainly made everything more challenging, we expect the initiation of this study later this quarter. Lastly I'd like to remind you of our clinical program for CI-8993 a monoclonal antibody designed to antagonize the VISTA signaling pathway.

In January 2020, we entered into an option and license agreement with ImmuNext for the development and commercialization of anti-VISTA antibody including its lead compound CI-8993. VISTA is a meaningful and exciting target in oncology. And we look forward to leveraging our insights and experiences from prior VISTA studies as we advance CI-8993.

We expect to initiate our Phase I dose escalation study as early as the second half of this year. I'll now turn the call over to Bill for a summary of our financial results for the quarter.

Bill?.

Thank you, Jim. The first quarter of 2020, Curis reported a net loss of $9.7 million or $0.28 per share on both a basic and diluted basis, as compared to a net loss of $9.9 million or $0.30 per share on both the basic and diluted basis for the same period in 2019.

Revenues for the first quarter of 2020 were $2.7 million, as compared to $1.8 million for the same period in 2019. Revenues for both periods comprised primarily of royalty revenues recorded on Genentech and Roche's net sales of Erivedge.

Operating expenses for the first quarter of 2020 were $11.2 million as compared to $7.3 million for the same period in 2019. Positive royalty revenues were $0.1 million for both the first quarter of 2020 and 2019. Research and development expenses were $7.5 million for the first quarter of 2020 as compared to $4.1 million for the same period in 2019.

The increase was primarily due to in-license expenses incurred from our option and license agreement with ImmuNext; and increased costs related to clinical activities including consulting, outside lab expenses and CRO services.

General and administrative expenses were $3.6 million for the first quarter of 2020, as compared to $3.1 million for the same period in 2019. The increase was driven primarily by higher legal services during the period. Net other expense was $1.2 million for the first quarter of 2020 as compared to $4.3 million in the same period in 2019.

Net other expense in 2020 consisted primarily of imputed interest expense related to future royalty payments. Whereas in 2019, the expense related primarily to a onetime loss on extinguishment of its total debt.

As of March 31, 2020 Curis' cash, cash equivalents, marketable securities and investments totaled $12.5 million and there were approximately 36.6 million shares of common stock outstanding. Curis expects that its existing cash, cash equivalents and investments should enable it to maintain its planned operations into the second half of 2020.

With that I'd like to open the call for questions.

Operator?.

Operator:.

Thank you, Jamie. I'd like to end today's call by thanking all of the patients and families who continue to participate in our clinical trials, as well as our internal team at Curis for their hard work and commitment and our partners at Aurigene and ImmuNext for their support.

Thank you for joining our call today and we look forward to updating you again soon.

Jamie?.

Ladies and gentlemen, that does conclude today's conference call. We do thank you for joining today's presentation. You may now disconnect your lines..