Q3 2019 Earnings Call

Good afternoon, and welcome to the curious third quarter earnings call.

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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 welcome mature since third quarter 2019 earnings call.

Before we begin I would encourage everyone to go to the Investor section of our website at Www Dot cures Dot Com responder third quarter 2019 earnings release and related financial tables.

I'd 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.

Actual results may differ materially.

For additional details please see our SEC filings.

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

Also be available for Q1 at the end of the call.

I'd now like to turn the call over Genesis CEO , Jim Dentzer. Thank you Bill.

Good morning, everyone and thank you for joining us today for our third quarter 2019 earnings call in business update.

Our mission that Curis is to develop the next generation of targeted cancer drugs to help patients 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 independence that.

And see a 4948 study is enrolling well and on track for data read outs 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 to PDL, one and the only candidate of its kind in the clinic.

Earlier today, we announced initial efficacy data from our phase one 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 one study was designed to evaluate the safety recommended phase two dose and maximum tolerated dose of CA 170.

Secondary endpoints of this trial were pharmacokinetic or PK.

And the anti cancer activity.

Exploratory endpoints included Biomarkers, and Pharmaco dynamic 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 milligrams twice daily of CA 170.

Well the low dose cohort received 200 milligrams twice daily CA 170.

Patients who did not respond to.

Perions disease progression that the 200 milligram twice daily dose were then crossed over to the high dose cohort.

Now to the data.

Of the 12 patients enrolled 11 patients have discontinued treatment with no partial or complete responses observed per response evaluation criteria in solid tumors or resist.

11 patients were on treatment for at least one post baseline disease assessment.

And of the 11, Becky valuable patients seven how to best response, a stable disease.

This includes two of three patients at the 200 milligram twice daily dose with a mean duration of 64 days.

And five of eight patients assigned to or escalated to the 1200 milligrams twice daily dose.

With a mean duration of 115 days.

While in this population stable disease for an extended period is certainly better than quick progression.

We do not feel these data warrant additional study a CA 170, as a monotherapy therapeutic in mesothelioma.

It is our strategic imperative to focus our team and our capital on our clinical development programs, where we believe our candidates have the greatest potential to serve as novel effective therapies for patients with cancer.

Although we did not observed single agent efficacy in this mesothelioma trial.

We believe that CA 170, particularly as a PDL one antagonist may be effective and other cancer situations.

We also continue to believe that Vista is an important and scientifically validated target with significant potential as a therapeutic approach for difficult to treat cancers.

So we will take a deep look at the patient data from phase one.

And from the Phase two study conducted by our partner Aurigene.

To evaluate the potential of CA 170 in other indications.

We have also gained valuable insights from this study on Vista as a target.

Which will help us to determine how we made better address vista in the future.

We will provide guidance on next steps for CA 170, and our work on Vista once we have them.

And we look forward to updating you.

Now I'd like to give a brief overview of our two other clinical candidates and then I'll turn the call over to Bob for more detail.

As many of you know, we're currently evaluating evaluating CA four nine full rate.

In patients with relapsed refractory diffuse large b cell lymphoma or Dl bcl.

And Waldenstrms Macroglobulinemia.

In an ongoing phase one dose escalation study.

We announced encouraging initial data earlier this year.

And are on track to report updated safety and efficacy data from this study before year end.

And as we announced last quarter, we're planning to initiate a separate phase one trial of CA four nine for rate in patients with acute myeloid leukemia and Myelodysplastic syndrome.

We're also advanced advancing our ongoing phase one study of semifinished at a mix suppressor in combination with phonetic lacks a bcl two suppressor for patients with deal Bcl.

We remain on track to report initial safety data from this study in the fourth quarter of 2019.

And with that I'll turn the call over to above.

Thank you Jim.

Hello, everyone and thanks for coming and joining us this morning.

I'll start with similar to invest at our anti Mic program, which targets both the genetic transcription and protein degradation of Mick.

Semifinished stat uniquely targets Mick through simultaneous inhibition of both CPI three kinase and H. deck.

Two enzymes that are essential to manifest mixed arrangement in cancer as you may know make levels, our enhanced in many malignancies through a variety of mechanisms.

We and others have shown synergy and targeting both h. stack npis retain a simultaneously.

We have the advantage in semifinished stat of targeting both inside and is within the same molecule and we have shown clinically that both enzymes are inhibited.

In clinical studies to date in patients with Myc altered deal Bcl set of tennis Stat has 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 deal Bcl, a patient group with the most challenging prognosis.

We decided to combine independent stat with phonetic KLAX, an anti lymphoma agents in our phase one study for two main reasons.

First since the strong benefit of set of tennis stat 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 Filipino stats benefit to take hold.

Seconds.

Double hit lymphoma, one of the deadliest types of lymphoma is defined by alterations in both Mick and Bcl two.

Since Venetoclax is a rapidly acting drug targets Bcl two.

It's combination with our mix suppressor Filipina stat is we believe in 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 phase one study is designed to evaluate the safety and Tolerability.

The pharmacokinetics and pharmacodynamics and the anti cancer activity of the 10 of tennis stat, and Venetoclax combination in patients with relapsed or refractory Dl bcl, including those with double hit lymphoma.

We are enrolling patients in two cohorts in this study.

In the first cohort patients received 30 milligrams incentive tenants stat, and 400 milligrams of Venetoclax daily.

These are doses debt.

Have already demonstrated clinical activity as single agents.

In the second cohort patients will receive full doses of each agent.

60 milligrams of significant stat, and 400 milligrams of Venetoclax daily.

We plan to continue dose escalation until the recommended phase two dose has been identified and we expect to report initial data from this study later this year.

Moving on to CA four nine for age.

See for 948 is a first in class orally available small molecule inhibitor of Iraq for a critical component of the mid film in the TLR pathway, which leads downstream to b cell proliferation.

On Cogentix rack for alcohol is also produced as a result of splice facility mutations found in many cases of am now in Mds.

Dysregulation of this pathway is known to cause cancer. Yet there are currently no approved therapies targeting this pathway.

With FCA for 948, we have a potential therapeutic that could serve to block this cancer, causing pathway.

In preclinical models CA 404, eight repressive TLR and TLR Im sorry, TLR and I'll, one receptor signaling pathways as well as cytokine production in vitro and exhibits anti tumor activity in Dl Bcl two.

Presented graft models as well as in patient derived xenograft.

Our ongoing phase one dose escalation study CA 4948 in patients with relapsed refractory DLP, Seattle and Waldenstrms Macroglobulinemia is designed to evaluate the safety and Tolerability of CA 4948.

In addition to PK.

D and anti cancer activity with the goal of identifying the dose with which to move on phase II.

We're enrolling patients across nine study sites in the U.S.

With at least three patients enrolling her dosing cohort.

We have dose patients in continuous 21 days cycles.

Initially at 50 milligrams once daily.

And has since escalated all the way up to our client dose of 400 milligrams twice daily.

Through the 200 milligram twice daily dose CA 4948 demonstrated a clean safety profile.

Dose proportional PK and strong evidence of Pharmacodynamic inhibition of signaling of this oncogenic pathway.

And as we announced last quarter, we have seen evidence of anti tumor activity in several patients across dose levels with greater activity observed as the doses increased.

This initial data is quite encouraging and we are continuing to dose escalate until we define the maximum tolerated dose and determine the recommended dose for phase two studies.

This study is progressing well and we expect to present updated data on CA 4948 at an upcoming medical meeting.

Lastly, as Jim mentioned, a plan to initiate a separate phase one trial of CA 4948 in acute myeloid leukemia and Myelodysplastic syndrome.

We plan to provide further updates on this program as we finalize the study protocol and initiate our first trial in these indications.

So that sums up our ongoing clinical programs for Filipina stat, and CA 4948, and we are greatly looking forward to reporting data on both candidates.

Before year end.

I'll now turn over the call to build to discuss this quarter's financial results Phil.

Thank you Bob.

Now for an update on our financial results.

The third quarter of 2019, we reported a net loss of $6.4 million or 19 cents per basic and diluted share.

As compared to a net loss of $7.2 million.

Were 22 cents 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 2018.

Research and development expenses of $5.1 million from 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 four nine for it.

General and administrative expenses were $2.9 million for the third quarter 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 costs during the period.

Other expense.

It was $1.1 million with third quarter 2019.

As compared to zero point $8 million for the same period in 2019.

The third quarter 2019.

Net other expense primarily consisted of computer and interest expense related to future royalty payments.

Whereas in 2018 the expense related to interest occurred.

I'm curious royalties debt obligations.

As of September 32019, 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 phone Penneast and see a four nine for it and into the second half of 2020.

Now I'd like to open the call for questions operator.

We will now begin the question answer session.

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At this time, we will pause momentarily to assemble our roster.

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 continue to execute on the goals, we laid out for our company at the end of 2018.

Although we did not observed 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 subsea oneseventy as well as the patient data from the phase one study to determine our plan for future clinical development.

We also continue to believe that Vista is an important and scientifically validated target. It is worth studying further and we'll 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 it and advancing our clinical programs for Timothy Monistat and see if or 9.8 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 that 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.