Q1 2020 Earnings Call

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Operator: We'll be in a listen-only mode. Should you need assistance, please see 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 and then one. To withdraw your question, you may press star and two. 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.

Did you need assistance, please no corporate specialist Starkey followed by zero.

After the company's prepared remarks call participants will have an opportunity to ask questions.

The ask your question you May press Star one to withdraw your questions you May press star and too.

Please note today's about is being recorded.

At this summer like to turn the conference calls over to the company's Chief Financial Officer Bell Steinkrauss. Sir. Please go ahead.

Thank you.

Bill Steinkrauss: Thank you and welcome to Curis' first quarter 2020 earnings call. Before we begin, I would encourage everyone to go to the investor section of our website, 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 that are based on our current expectations and beliefs. These statements are subject to certain risks and uncertainties, and actual results may differ materially.

Welcome to Curis Inc. first quarter <unk> earnings call.

Before we begin I would encourage everyone to go to the Investor section of our website at Www Dot Curis Dot com.

And our first quarter 20 twond.

Earnings release related financial tables.

We're also like to remind everyone that during the call.

Management will be making forward looking statements are based on our current expectations and beliefs.

These statements are subject to certain breast.

Uncertainties.

Actual results may differ materially.

For additional details please see our SEC filings.

Bill Steinkrauss: For additional details, please see our SEC filing. 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.

Joining me on todays call, our Jim Dentzer, President and Chief Executive Officer, and Bob Martel head of R&D.

We will also be avail.

For Q1 I ended the call.

I'd now like turn the call over the characters CEO, Jim Dentzer Jim.

James E. Dentzer: Thank you, Bill. Good afternoon, everyone, and thank you for joining us today.

Thank you Bill.

Afternoon, everyone and thank you for joining us today.

Before we recap the quarter.

James E. Dentzer: 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 seek, 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 resilience 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 arise. 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.

I'd like to make a few general comments about the coping 19 situation and its impact on our work both internally and with respect to our ongoing clinical studies.

As we seek along with the rest of the world.

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 distinct 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 arise.

We're fortunate to be able to productively and efficiently advanced power business.

I would shrink public health guidelines and working remotely.

Clinical side.

We are working closely with our partners CR rose manufacturers and study investigators and stuff like each of our clinical sites to protect patients' health and safety and ensure the we see on interrupted access to study drug in a matter that preserves the integrity and rig.

James E. Dentzer: We are working closely with our partners, CROs, manufacturers, and study investigators and staff at each of our clinical sites to protect patients' 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 IRAC-IV program with CA-4948.

Of our clinical trials.

With that I'd like to review, our clinical development programs.

Let's start with how IRAK four program, we see a for 9.8.

As a reminder, we're currently evaluating see eight or 948, an IRAK four trainees inhibitor in an ongoing phase one dose escalation study for the treatment to patients with relapsed refractory non hodgkin's lymphoma, including patients with diffuse large b cell lymphoma.

James E. Dentzer: As a reminder, we are currently evaluating CA4948, an IRAC-4 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, Waldenstrom's macroglobulinemia, and an oncogenic MIT88 mutation. While the pace of enrollment has slowed, as certain sites have temporarily halted enrollment due to the pandemic, several of our Phase I 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 two dose later this year.

Waldenstrms Macroglobulinemia, it's oncogenic Mydeighty eight mutation.

Well the pace of enrollment has slowed.

Certain types of temporarily halted enrollment due to the pandemic.

Several of our phase one study sites remain open and our recruiting new patients.

At the moment, we are evaluating patients being treated with 300 milligrams twice daily.

After observing clear dose response and tumor reduction the previous dose levels.

We're pleased with the results from the study so far and we remain on track to provide updated safety and efficacy data and declared the recommended phase two dose later this year.

I'd also like to touch on our second program for CA four nine portrayed.

James E. Dentzer: 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 IRAC Further...

In patients with acute myeloid leukemia or email.

And Myelodysplastic syndrome or Mds.

The air, though and Mds community was excited by the groundbreaking presentation by Dr. Aamodt, Vermont Feinstein at the Ash conference in December.

Which he highlighted the role of specific splices, so mutations as key drivers of Iraq for L expression.

Further.

He identified Iraq for L. B on Progenics long isoform of Iraq for.

James E. Dentzer: He identified IRAC4L, the oncogenic long isoform of IRAC4, as the first and, to date, only known driver of disease that affects over half the population of patients with AML and MDS. We provided CA-4948 to Dr. Verma to explore in his lab, and in preclinical studies, he found that blocking this long isoform of IRAC4 with a treatment of CA49POR8 was shown to These preclinical data demonstrated, for the first time, a clear genetic driver of disease affecting the majority of the AML and MDS patient population.

As the first and to date only known driver of disease that affects over half the population of patients with AML and Mds.

We provided see for 9.2 Dr. Berger two explored his lab.

I Didnt preclinical studies.

He found that blocking this long isoform IRAK four with with the treatment of city for 9.8, what's shown to dramatically reduce the formation of leukemic blast.

These preclinical data demonstrated for the first time.

Clear genetic driver of disease.

During the majority of the AML and Mds patient population.

It is also uniquely exciting for curis given that our drug directly targets. This oncogenic kinase IRAK four L.

James E. Dentzer: It is also uniquely exciting for Curis, given that our drug directly targets this oncogenic kinase, IRAK4L. We are currently working with our clinical sites and investigators to initiate a Phase I study of CA-4948 in AML and MDS patients, although the coronavirus pandemic has certainly made everything more challenging. 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 Immunex for the development and commercialization of anti-VISTA antibodies, 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 TI-8993. We expect to initiate our phase one 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.

We're currently working with our clinical sites and investigators to initiate a phase one study of CCH for nine for age in AML and Mds patients.

Well the Corona virus epidemic has certainly made everything more challenging.

We expect initiation of this study later this quarter.

Lastly, I'd like to remind you of our clinical program for C. I 80 993.

Monoclonal antibody.

Designed to antagonize the Vista signaling pathway.

In January 2020.

We entered into an option then license agreement with indexed for the development and commercialization of anti Vista antibodies, including its lead compound. She I 80 993.

This study 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 <unk> 80 993.

We expect to initiate our phase one dose escalation study as early as the second half of this year.

I'll now turn the call over to build for a summary of our financial results for the quarter.

No.

Thank you Jim.

Bill Steinkrauss: Thank you, Jim. For the first quarter of 2020, Curis reported a net loss of $9.7 million, or 28 cents per share on both a basic and diluted basis, as compared to a net loss of $9.9 million, or 30 cents per share on both a 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 comprise primarily of royalty revenues recorded on Genentech and Roche's net sales of AeroVeg. Operating expenses for the first quarter of 2020 were $11.2 million, as compared to $7.3 million for the same period in 2019. Cost of royalty revenues, for $0.1 million for both the first quarter of 2020 and 2019.

The first quarter 220, purist reported net loss of $9.7 million.

28 cents per share on both a basic and diluted basis.

As compared to a net loss of $9.9 million worth 30 cents per share on both a basic and diluted basis. The same period in 2019.

Revenues for the first quarter 2020 were $2.7 million as compared to one point.

Same period in 2019.

Revenues for both periods comprised primarily of royalty revenues recorded on Genentech and Roche's net sales error budge.

Operating expenses for the first quarter 2020 were $11.2 million as compared to $7.3 million for the same period in 2019.

Cost of royalty revenues.

Were zero point $1 million for both the first quarter of 2020.

In 2019.

Research and development expenses were $7.5 million that first quarter of 2020 as compared to $4.1 million for the same period in 2019 <unk>.

Bill Steinkrauss: 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 Immunex 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.

The increase was primarily due to in license expenses incurred from our option and license agreement with give me next.

Increased costs related to clinical activities, including consulting.

Outside lab expenses and see a row services.

General and administrative expenses were $3.6 million for the first quarter 2020, as compared to $3.1 million 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.

Bill Steinkrauss: Net other expense was $1.2 million for the first quarter of 2020, as compared to $4.3 million for 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 one-time loss on the extinguishment of historical 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.

As compared to $4.3 million the same period in 2019.

Net other expense 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 historical data.

As of March 31st 2020, Christmas cash cash equivalents marketable securities and investments totaled $12.5 million and there were approximately 36.6 million shares.

Stock outstanding.

Curis expects that its existing cash cash equivalents an investment.

Should enable us to maintain its planned operations into the second half 2020.

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

Right.

Operator: Ladies and gentlemen, at this point, we'll begin the question and answer session. To ask a question, you may press star and then 1 on a touch-tone telephone. If you are using a speakerphone, we do ask that you please pick up the handset before pressing the keys to ensure the best sound quality. To withdraw your questions, you may press star and, Once again, to ask a question, that is star and then one. We'll pause momentarily to assemble the roster. And gentlemen, at this time, in showing no questions, I'd like to turn the conference call back over to the company's president and chief executive officer, James Dentzer, for any closing remarks.

Ladies and gentlemen at this point will begin the question and answer session.

I asked the question you May Press Star then one using the touched on telephone.

If you are using a speaker phone. They do ask you. Please pick up the handset before pressing the keys to ensure the best sound quality.

So what's your all your questions you May press star into.

Once again to ask a question that is star and then one well pause momentarily to assemble the roster.

And gentlemen at this time and showing no questions like to turn the conference call back over to the company's President and Chief Executive Officer, James Dentzer for any closing remarks. Thanks.

Jamie.

James E. Dentzer: 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 Origin and Immunext for their support. Thank you for joining us on our call today, and we look forward to updating you again soon.

I'd like to end today's call by thinking all look the patients and families who continue to participate in our clinical trials.

As well as our internal team at curious for their hard work and commitment.

And our partners it or gene and maybe next their support.

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

Okay.

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

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.

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