Good morning, and welcome to the Curis Fourth Quarter and Full-Year 2017 Earnings Conference 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 Chief Financial Officer and Chief Administrative Officer of the company, Mr. James Dentzer. Please go ahead, sir..

Thank you, operator, and welcome to Curis’ fourth quarter 2017 earnings call. Before we begin, I would like to encourage everyone to go to the Investor section of curis.com to find our earnings press release and related financial tables. I would also like to remind everyone that we 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 our actual results may differ materially. I encourage you to consult our SEC filings for additional detail. I will now turn the call over to our President and CEO, Dr. Ali Fattaey. Ali?

Thank you, Jim. Good morning, everyone, and thank you for joining us today. 2017 was a year with significant clinical data for our drug candidates and we look to use these for creating considerable value for our shareholders in 2018. Curis’ achievements in 2017 included demonstrating that CUDC-907 is an active agent in patients with MYC-altered DLBLC, with nearly one in four treated patients experiencing a durable objective response. Also, establishing that CA-170 can significantly increase cytotoxic T cell numbers in patients tumors and resulted tumor shrinkage at a safe oral dose. Further, we were successful in bringing CA-4948 IRAK4 Kinase Inhibitor into the clinic to test its anticancer activity in patients with lymphomas. We’ve also readied CA-327 for first-in-man clinical testing and have secured sufficient capital for our operations into the second-half of 2019. These accomplishments are consistent with our business strategy to develop multiple oncology drug candidates, which we expect to commercialize in certain territories should they reach their registration state. Now today, I’d like to provide a brief update on each of these, as well as our expectations for 2018. I’ll begin with CUDC-907. At the ASH Annual Conference in December last year, we presented the combined Phase 1 and Phase 2 clinical experience with CUDC-907 in patients with relapsed/refractory DLBCL. Of the total 105 patients with relapsed/refractory DLBCL treated with CUDC-907, 60 were identified to have MYC-altered disease. And of this 60, 14 patients had an objective response, including eight, that is over half of the responders experiencing complete responses. The median duration of response for these patients was 13.6 months. Based on these results, we conclude that beyond one year of durable benefit in approximately one in four treated patients is a significant clinical benefit for patients with relapsed/refractory DLBCL in general. Now recent reports,…

Thank you, Ali. For the year ended December 31, 2017, we reported a net loss of $53.3 million, or $0.36 per basic and fully diluted share, as compared to a net loss of $60.4 million, or $0.45 per basic and fully diluted share in 2016. The net loss for the year ended December 31, 2016 includes a non-cash in-process research and development charge of $18 million related to the amendment of Curis’ license agreement with Aurigene. For the fourth quarter of 2017, we reported a net loss of $8 million, or $0.05 per basic and diluted share, as compared to a net loss of $11.3 million, or $0.08 per basic and diluted share for the same prior year period. Revenues for the year ended December 31, 2017 were $9.9 million, as compared to $7.5 million for the same period in 2016. Revenues were $3.3 million and $2.4 million for the fourth quarter of 2017 and 2016, respectively. Revenues for both periods comprised primarily royalty revenues recorded on Genentech and Roche’s net sales of Erivedge. Operating expenses were $59.7 million for the year ended December 31, 2017, as compared to $65.6 million for the same period in 2016. Operating expenses were $10.4 million for the fourth quarter of 2017, as compared to $13.1 million for the same period in 2016. Research and development expenses were $45.1 million for the year ended December 31, 2017, as compared to $31.6 million for the same period in 2016. The increase was primarily due to two payments to Aurigene for $3.75 million each for an exclusivity option, which were paid in January 2017 and September 2017, as well as increased costs related to the ongoing clinical activities for CA-170. Employee-related expenses increased over the prior year period, primarily due to higher stock-based compensation and personnel…

We will now begin the question-and-answer session. [Operator Instructions] The first question comes from Adnan Butt with Guggenheim Securities. Please go ahead.

Good morning, folks, and thanks for the question. I have two. First on 907. Ali, at this point, is it more likely to see responses from the Curis sponsored Phase 1 or the Phase 2? The reason I ask that is, because you seem to be dose escalating in the Phase 1. So is the India Phase 2 study, is that following a similar schema?

Adnan, I apologize, I think, you said CUDC-907 Phase 1?

I’m sorry, I meant 170. I meant 170, sorry?

Okay.

170, you’re dose escalating in Phase 1, is Phase 2 in India following a similar schedule? Which one is – will be the first to response – will be the first to report some activity?

So maybe the first answer to your question of the trial in India, and I think, we’ll present some of that in – with our partners of Aurigene. But the trial is enrolling patients predominantly at one dose, which is 800 milligram dose is the current treatment that they have done so far. If there is other dosing and other dosing schedules that we believe based on the Phase 1 trial, the ongoing Phase 1 trial here, that would be more advantageous then there’s an opportunity to integrate and incorporate that into the Phase 2 trial as well, but it is really not a dose escalation in the India study.

Ali, in Phase 2 on the update?

And then, sorry, in the context of which one is likely to – we see both of them as fantastic opportunities to get access to patients. And in particular, in India, which not only immunotherapy treatment naïve, but patients in earlier lines of treatment is a significant advantage for us.

The reason I ask is that, because clearly the exposure has been increased in the Phase 1 study, am I right?

In the – our preliminary data from the current cohort that I described using 600 milligram twice-daily dosing to us it appears to be a clear improvement and exposure for the patients. And obviously, we are in discussion with our colleagues at Aurigene in terms of how to integrate that in the study as well, that’s correct.

Okay, I’ll follow-up later. But let me ask one on 907. The language theme is very optimistic in terms of next steps. What is specifically the company waiting on?

As I indicated, yes, you are correct. We are very optimistic and have always been optimistic with the level of clinical benefit that CUDC-907 seems to provide. I think, we’re further emboldened with the recent publications as the other trial reports that I mentioned, including the REFINE study, which really was not available at the time that we did the interim analysis of the Phase 2 trial for CUDC-907. These study really indicate that, in general, relapsed/refractory DLBCL patients do extremely poorly and even more poorly when they have a MYC-altered diagnosis or their prognosis is very low in terms of their overall survival benefit. When we compare our data of over a year of this duration of response, that’s a significant improvement with over what we see as a single-digit months of median overall survival for the patients. So, yes, we’re – we’ve continued to be optimistic and we’re further emboldened with these data. We have been discussing, as indicated previously and today, we’re in discussions with the regulatory authorities to really define and establish a consensus path for what a right study is for CUDC-907 for its pivotal path. In addition, I as mentioned, we’re preparing with commercial manufacturing, as well as diagnostic development discussions to ensure that we can – once the trial is designed and agreed on to be able to have all elements hitting on time to really put the drug on its registration path for CUDC-907.

Ali, thanks. Just one clarification. So your discussions with the FDA have not yet concluded and you will update the Street or update us when they are finalized, is that fair?

That’s correct.

Okay. Thank you.

Sure. Thank you, Adnan.

The next question comes from Brian Skorney with Robert Baird. Please go ahead.

Hey, good morning, guys. Thanks for taking the questions. Just really on CA-170, I know at SITC, the number of patients that were presented were 39. Just when we think about the continued dose escalation that you guys are doing, I guess, the first question is, how many additional patients who we see at the next update from that 39 worth of data? Do you have any estimate in terms of how many patients worth of data we can get from the Aurigene Phase 2? And I know at SITC, one of the concerns was just enrolling patients who are I/O naïve, who seemed to be pretty far progressed and we didn’t see a lot of, I think, less than half of the patients made it really past one-month. So I was just wondering in terms of additional patient enrollment how you’re handling trying to get patients in who may be able to tolerate getting drug for a little longer than month, so you have a greater follow-up? Thanks.

Sure. Thank you, Brian, for the question. Let me answer it for you maybe in two parts. One is the concept of the types of patients that we’re enrolling. And of course, I agree that in the initial parts of the dose escalation, and I would say, that includes the earlier doses before we really are at these later more high exposure doses. It is correct that a number of the patients and in particular patients in the U.S. that we had been enrolling have fairly advanced disease and have had a significant number, obviously, over five or more. Prior treatment regimens and prior treatments, which in a sense, although they’re I/O naïve, they have been fairly heavily pre-treated. I think more recently, including the patients that we have been successful in enrolling in Korea and in certain places in Europe including Spain have had fewer prior treatment regimens, which does help us in that scenario and their immunotherapy treatment naive. In India, in particular, and this was one of the advantages that we saw and Aurigene has been successful, obviously, in carrying out this strategy is not only enrolling patients of high interest and then being immunotherapy treatment naïve, there are earlier lines of treatment as well. So no more than three prior treatments is really allowed in the Phase 2 trial in India. So that’s with respect to the quality of the patients or prior treatment rounds, as well as them all now being immunotherapy treatment naive. With respect to numbers, I think, from the Phase 1 trial at the time that we would come to provide more updates, it would be certainly upwards of 50 patients for you to be able to see from the Curis side and not to jump in terms of Aurigenes their own update in this regard. But we would certainly expect over 20 or more patients from the Phase 2 trial to have had significant follow-up and multiple cycles of treatment by the midyear time point for us to be able to assess the drug in the Phase 1 and the Phase 2 trial. I do also want to point out what we described this newer findings of – so that’s the Phase 1 and the Phase 2 that’s ongoing and those are two opportunities. We do believe this newer findings of VISTA expression fairly significant VISTA expression on some patients’ tumor cells may provide a fairly – good opportunity for us to go selectively look at those patients specifically and select them for enrollment. No plans yet for us to update that, but it is a place where we are actually exploring. So that, that can provide a third avenue for us for a – for the further development of CA-170s in addition to the Phase 1 and the Phase 2 trial in India.

Great. Thanks, guys.

Thank you, Brian.

The next question comes from Santhosh Palani with Cowen. Please go ahead.

Hi, Ali, thank you for taking my question. So maybe a couple on CA-170 and one on CUDC-907. The CA-170, you did mention that you guys are dose escalating and also looking at the BID schedule of the 600 and possibly then into 900. Can you talk as you increase exposures, are you seeing modulation in pharmacodynamics, especially with respect to immune modulation and whether that is giving you the comfort that potentially expanding in those higher dose levels of higher exposures could lead to anti-tumor activity?

Good morning, Santhosh, and thank you for your question. With regards to the BID dosing, it’s a little early for us to comment on the pharmacodynamics yet just because they’re in process in a sense. We really don’t expect to see anything different as we indicated. We did see fairly significant pharmacodynamic activity in the once-daily dosing already, as I mentioned, six out of the 10 patients that we had tissue for analysis had a very significant increase in or they had increase in their CD8-positive cytotoxic T cells. But that data is a little early for the BID dosing and obviously, we have an interest in evaluating that as well. So no no updates on that front at this point. From a pharmacokinetic…

Got it, got it.

All right. From a pharmacokinetic though, just so I can reiterate it. We do see a fairly good significant advantage as an offense. It’s keeping the steady state levels of the drug at a very high level in a continuous manner. So in a sense, we eliminated trough levels for this drug to a great extent.

I’d say with the BID dosing, yes…

With the BID, yes, the BID dosing.

That makes sense. Yes. So maybe –so, Ali, you actually brought up this point and it is quite striking to see that, for example, in the patients you have enrolled, there are seven media prior lines of therapy. So can you walk us through what should be the expectation even for checkpoint inhibitors like nivolumab or pembrolizumab and does that provided in early lines of treatment versus really late lines of treatments like the patients you are enrolling with respect to what’s been absorbed so far in literature? And so to make a more fair comparison in terms of what you’ve seen with what’s been absorbed with antibodies?

No, it’s actually an excellent point. And I think, I appreciate you asking the question. It’s – we are actually putting that data together and going back and have looked at the realistically the Phase 1 data for the anti-PD-1 antibodies in particular to look at the patient benefit that was observed, because obviously, we’re getting a little bit spoiled now comparing to fully vetted approved drugs in Phase 3 trials fairly established and optimized dose for them versus a Phase 1 trial for dose escalation of our drug. But one that I can tell you, for example, when we looked at this one in melanoma, we do see obviously with anti-PD-1 drugs, they do have a very good benefit. And in fact, in the front-line setting, they have benefit in excess of 25% of patients getting an objective response. But really in the second-line treatment, that objective response drops into the very low teens. So you are correct that, as patients go through multiple cycles of non-immunotherapy treatment, they do appear to do slightly worse or worse or the response rate aren’t as high, which means the opportunity for seeing at in a Phase 1 trial of uncollected patients in a dose escalation is further reduced. So it’s a good point, allow us to put the data together and perhaps will present that in that light as well in a more fairer comparison of what should be expected for CA-170.

Got it. And can you talk to the – how the India trial could potentially help us in the sense that there you could potentially now enroll in more earlier line of I/O naive patients and maybe that presents a more representative data set in terms of what the – as you mentioned, like kind of spoiled seeing that they’re more like the front and the second-line datasets from antibodies?

Yes, sure. And as we just noted with in response to Brian’s questions just before yours, the trial – the Phase 2 trial that Aurigene is conducting in India, and again, I’m in some respect speaking on behalf of their trial that they’re conducting there. But it’s designed in a way that we designed it with them was to get patients at an earlier line of treatment no more than three prior and the earlier the better they’re allowed to come in into the study. And we really do look to be able to get that population of patients not just immunotherapy treatment naïve, but with very few – the less, the better, but no more than three prior treatment regimens before they come into a CA-170 trial. So that should help us with access to both earlier line patients, as well as them being immunotherapy treatment naïve. The other thing is that, we will get access and do get access to patients that are really difficult now in the U.S. or other centers, including MSI high patients, which are obviously in high demand. We do have an opportunity to get access to that. Obviously, that can provide a significantly better chances of seeing significant clinical benefit in those patients.

Got it. Just one last question on 170. So can you talk to the little bit about pre and post biopsy requirements and how many pairs do you have at this point with the Phase I trial and whether it’s mandated in the India trial?

Yes, it’s a good question. It – in the Phase 1 trial, we did mandated for this later stages of the dose escalation. If you recall, the initial first three or four cohorts were single patient and it was not mandatory. But since the 400 milligram dose, which is a three plus three design from there in the Phase 1 trial dose escalation, pre and post has been mandatory, obviously, with the exception that if it’s – could provide a risk for the patients then physicians can ask us not to do that. In India as well, that is an important part of it. And we do ask and – for the collection of patient samples in there as well. We’re likely to hold those and run them more as a batch as opposed to them coming on in the same sort of – as they are enrolled, but patient sample access in India is also an important part of the safety trial.

Sorry. Just one more question on 170. So have you guys submitted any abstracts or anything for ASCO? Is ASCO an event where we could see an update for the Phase 1 study?

We would like to present – so rather than indicating whether we submitted an abstract or not, but we would like to present somewhere around midyear a scientific conference would obviously be preferred an update on the clinical experience with CA-170, including the Phase 1 trial, as well as the Phase 2 trial India experience as well.

Got it. And just one question on CUDC-907. So based on the – you mentioned that based on the recent studies and the literature you guys have looked at in terms of what’s available for MYC-altered DLBCL patients and comparing that efficacy to what you observed with your Phase 2 trial, it seems like there is really no good control arm, if we are thinking about a randomized trial as a potential pivotal trial. So can you clarify that when you’re thinking about a potential registrational trial based on what information you have already primarily looking at a single arm trial at this point with probably response rate and may be somewhat of a durability as a primary endpoint?

Yes, it’s a good point. Maybe answer the first part of your question with respect to the historical controls. You are correct, there is very little, in fact, data available that looks at relapsed/refractory DLBCL patients in terms of how they’ve done and then more importantly, less – certainly, a lot less on MYC-altered specifically relapsed/refractory DLBCL patients. Our read of all of the available data, including the ones that I mentioned in the REFINE study as well as the CORAL, the REFINE analysis and the CORAL really says that the MYC-alteration is an extremely poor prognosis for the patients all throughout the treatment from front-line, post transplant, post second-line and certainly that in the relapsed/refractory setting. But the historical available data is small, so that is a correct statement. We do think there is – just in the context of a study for CUDC-907, I should point out recalling that the Phase 2 trial that we ran, the interim analysis we looked at it at approximately 15 MYC positive patients, the Phase 2 trial itself is designed as 100 MYC-altered positive patients to be analyzed as an endpoint, the endpoint being response rate and durable responses. We do think that’s a viable path and non-randomized study that compares to historical. We do think that’s a path and that is part of our thinking in discussion. At the same time, we do think about a randomized study, because in the end, we will still need a randomized study that will look at CUDC-907, as compared to available therapies – available therapies,. as you point out, is realistically nothing other than experimental or doublets of chemotherapy. We had thought through both a non-randomized as well as a randomized study. We do think, there is non-randomized opportunity, including obviously the Phase 2 trial that is not fully enrolled yet at this point. Those are all parts of our discussions with us. We will provide that – all right, Santhosh, we will provide updates once our discussions with the FDA is concluded or is at a point that we feel comfortable being able to present it to the outside, as well as the full development path for CUDC-907.

Great. Looking forward to the update. Thank you for taking the questions.

Thank you, Santhosh.

[Operator Instructions] The next question comes from Peter Lawson with SunTrust Robinson Humphrey. Please go ahead.

Thank you, Ali. Thanks for taking the question. Just on CA-170. Do you think you’re at the right dose in India for Phase 2? It sounds like there’s a good chance it could up the dose in India?

It’s a good – first, good morning, Peter, and thank you for question. It’s always the biggest quandary of a Phase 1 trial, especially for a drug that does not have adverse events that we would be dosing to MTD to determine and triangulate in a sense what is the right dose. And as we’ve always indicated, adverse events can help us to an extent. pharmacokinetics, which has been a good driver for us so far is a good metric. The pharmacodynamic analysis and, of course, any patient benefit have all gone into our thinking. I do think, we are at a fairly significant exposure. So thinking about dose, I do think and we collectively think, 800 milligram dose is a significant exposure that can be significantly enhanced by twice-daily dosing. So the reason I’m answering your question that way is both a question of the dose, as well as the schedule. And we do at this point believe and prefer that twice-daily dosing schedule and have been in discussion with our colleagues in Aurigene as well to implement BID dosing within that study as well in the Phase 2 trial in India.

And do you think the data we see kind of midyear from Phase 2 would be the single dosing or double dosing?

A little too early at this stage. Obviously, some of these changes would require amendments, and so we are hopeful that we can show you both sets of possible data. At this stage, we do think there will be a significant numbers of patients in India that would have gone through multiple cycles of treatment and many of them would have had different, but there’s once-daily versus BID. It’s really too early to tell at this point, Peter.

Gotcha. And then how many patients you already have enrolled in India?

I think, that’s – so I want to be respectful of our colleagues at Aurigene have already probably discussed that a little bit more than since they’ve really not had the opportunity to present this. Just allow us to say, there are patients being enrolled and it’s – since it’s not a dose escalation, patients come in at multiple sites that they now have open and enrolled and they’ve been fairly successful in both the enthusiasm in India, as well as their ability to get trial sites – very high-quality sites up and getting patients in at this stage.

Great. Thank you. Just finally, just on 907, what do you think we could see the FDA update? Is that still this year, or it’s kind of midyear or just timing around that would be excellent? Thank you.

Sure. I think, towards the end of the year last year, we had guided for you and our colleagues. Obviously, we would like it to be as close to the end of Q1 and that’s really still our expectations, if it’s just on the other side of the end of Q1. So it’s fairly shortly that we would come back and try and update you and everyone else with regards to the – our discussions, as well as better outline what our development path looks like for CA – CUDC-907. What I do want you to go away with though is that, we are in full preparation for committing and conducting these studies and getting 907 on its registration path.

Great. Thanks so much, Ali.

Thank you, Peter.

And 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, Dr. Ali Fattaey, for any closing remarks.

Thank you. Thank you, everyone. At this point, I’d like to thank the Curis team for their hard work and advancing our drug candidates, or I should say, their drug candidates, and our partners, Aurigene, for the productive relationship that we have with them and all of the work that they’re doing in development of these drugs in collaboration with us. I would also like to thank our partners, Genentech and Roche, for the work with commercialization of Erivedge. As you noted from Jim’s comments, that Erivedge has had a consistent more than 20% year-over-year growth in its commercial sales, and we see that as a commitment that Genentech and Roche have to that drug. We also like to thank our investigators for their support with the development of our drug candidates. And most importantly, the patients and their families that participate in the trials of our drug candidates and making them a reality for other patients as well. Thanks, everyone.

The conference is now concluded. Thank you for attending today’s presentation. You may now disconnect.