Good day, ladies and gentlemen, and welcome to the Fourth Quarter Curis Inc. Earnings Conference Call. At this time all participants are in a listen-only mode. [Operator Instructions] I would now like to introduce your host for today’s conference, Mani Mohindru, Senior Vice President of Corporate Strategy, please go ahead.

Thank you, Christy. Good morning everyone, and thank you for joining us. During today's call, we'll provide you with an update on corporate developments and plans and also discuss fourth quarter and full year 2015 financial results. Before we begin, I'd like to advise you that this conference call contains forward-looking statements including, without limitation, statements relating to our strategy, future operations, future financial position, future revenues, projected costs, prospects, plans and objectives of the management; the potential therapeutic benefits of our drug development program and our plans to advance the development of drug candidates within these programs, as well as our expectation about Genentech and Roche's continuous development and commercialization of Erivedge. Actual results may differ materially from those indicated by forward-looking statements in this conference call as a result of various important factors, including those risk factors described in our quarterly report on Form 10-Q for the quarter ended September 30, 2015 and in other filings that we periodically make with the SEC, and we encourage you to review these risk factors carefully. We caution you that forward-looking statements we make in this conference call only represent our views as of today and that we may not update any of these statements even if events and developments subsequent to the date of this call cause our estimates and expectations to change. I'd now like to introduce Ali Fattaey, our President and CEO, who will provide an update of the Company and our development programs. Following Ali's remarks, Mike Gray, our Chief Financial and Chief Business Officer, will review our financial results for the fourth quarter and full year 2015, after which we will open the call for questions. Ali?

Thank you, Mani and thank you to the conference call and webcast participants for joining us this morning. We remain focused on building Curis by advancing our pipeline with the aim of eventual commercialization of innovative and effective drugs for the treatment of patients with cancer. We’re pleased to put our clinical stage drug candidate CUDC-907 on a path to registration with the recent initiation our Phase 2 clinical study in patients with MYC-altered relapsed refractory diffuse large B-cell lymphoma or DLBCL. Also during the fourth quarter of 2015, in our collaboration with Aurigene we in licensed two drug candidates, the first in the immuno-oncology is an orally available small molecule antagonist of PD-L1 and VISTA, checkpoint proteins that we’ve named CA-170. And the second is a potent and selective inhibitor of the IRAK4 kinase which we’ve designated CA-4948. We expect to file IND applications and to advance both of these drug candidates into clinical development in 2016. I’ll now provide additional details regarding these programs today. Now, I’d like to begin with CUDC-907. As I mentioned we recently initiated a Phase 2 trial to determine CUDC-907’s efficacy in patients with relapsed refractory DLBCL with cancers harboring alterations in the MYC oncogene. The design and patient population of the Phase 2 trial was driven by the promising efficacy and safety data presented by our lead investigator Dr. Anas Younes from the Memorial Sloan Kettering Cancer Center at the American Society of Hematology's annual meeting held in early December last year. In this presentation CUDC-907 was shown to be well tolerated with diarrhea, fatigue and non-symptomatic thrombocytopenia being the common adverse events of note. Those limiting toxicities of grade 3 diarrhea and grade 3 for hyperglycemia were only observed at the higher or more frequent doses and no dose limiting toxicities…

Okay, thanks Ali. For the year ended December 31, 2015 we reported a net loss of $59 million or $0.48 per share for basic and fully diluted rather as compared to a net loss of $18.7 million or $0.22 per basic and fully diluted share in 2014. The 2015 net loss includes a onetime charge for in process research and development expense of $24.3 million associated with our issuance of 17.1 million shares of Curis common stock to Aurigene under the terms of our January 2015 collaboration agreement. For the fourth quarter of 2015 we reported a net loss of $13.5 million or $0.10 per basic and fully diluted share as compared to a net loss of $5.7 million or $0.07 per basic and fully diluted share for the same period in 2014. The fourth quarter 2015 net loss includes $6 million in payments to Aurigene for our exercise of options to license the CA-170 and CA-4948 programs. Revenues for the year ended December 31, 2015 were $7.9 million as compared to $9.8 million for the same period in 2014. Substantially all of our revenues in 2015 and 2014 were recorded under our collaboration with Genentech. The decrease in revenue for the year ended December 31, 2015 was primarily due to a decrease in license fee revenues associated with the $3 million milestone payment that we earned during the year ended 2014. Revenues for the fourth quarters of 2015 and 2014 were $2.1 million and $2 million respectively and were comprised almost entirely [in vivo, in vitro] two revenues. Operating expenses were $64.4 million for the year ended December 31, 2015 as compared to $25.7 million for the same period in 2014. Operating expenses for the fourth quarter of 2015 were $15.3 million as compared to $6.8 million for the…

Thank you, Mike. Before we open up the call to questions I would like to certainly not least but last, would like to thank Mike Gray and [Jay Rayner] as you know you’re all aware of are leaving the company to pursue their other opportunities. We thank Mike especially for the many significant contributions that he has made during his tenure as the Chief Financial Officer and Chief Business Officer at Curis and we wish him well in his future endeavors. I would also like to thank Jay for her contribution in building the clinical development organization and bringing the clinical expertise at Curis as we prep ourselves for our expanding clinical pipeline to its instrumental and taking CUDC-907 through the Phase 1 testing and determining the dose and path forward for the drug candidate in patients with diffuse large B-cell lymphoma. We wish Jay well in her future path as well. The company has benefited greatly from both Mike and Jay's experience and insights and I join the board and the employees of Curis in thanking them for their years of valuable service. I also want to take the opportunity to introduce David Tuck, our Senior Vice President of Clinical and Transnational Sciences who will be leading the clinical developments activities at Curis. David has been with the company since the first half of 2015 and brings a wealth of experience in the field of immune oncology and drug development as well as biomarker development. For example, during his tenure at Bristol Bristol-Myers Squibb he was involved in the development of ipilimumab as well as other immune checkpoint inhibitors development. He has been an important addition to our team and will be leading the clinical efforts at Curis. I would now like to open the call to questions.

Thank you [Operator Instructions] our first question comes from line of Adnan Butt of RBC Capital Markets. Your line is open.

Thanks and nice progress on multiple [end shares]. First on 907 in terms of taking the Phase 2 that's ongoing into a registration enabling study has, what is the threshold that Curis is looking for and when would it hope to discuss those thresholds or the ability to do so with the regulators?

Thank you Adnan and thanks for the question. So far as I indicated, let me just re-ash just some of the Phase 2 design in the patient population it gives you a good sense of timing as well. The patient population is literally the same population that we enrolled for the Phase 1 trial so relapsed refractory patients with diffuse large B-cell lymphoma with the exception that the Phase 2 will select patients based on their MYC alteration before treatment. We do intend to enroll up to 16 patients in the monotherapy arm of this study that's an open label study which means we will able to view the data and we have certain looking points that we have established for ourselves during the enrollment process. We expect the enrollment to take somewhere in the 12 to 15 months timeframe for the study and as I indicated if the data as we go forward are consistent with what we have observed in the Phase 1 trial meaning that similar levels of response rate then we expect to discuss that with the FDA and ask for an expansion of this Phase 2 trial of the monotherapy arm to put the drug on registration path again using objective response rates as the primary end point.

Okay and maybe I can ask one on CA-170, the therapeutic window appears pretty wide so when would you expect to reach therapeutically relevant doses in the Phase 1, how quickly could you assess activity?

This is a good question. So, we feel quite comfortable that the drug is obviously safe in the models that we observed and again this is consistent both with other checkpoint inhibitors anti-bodies that have gone into the clinic and it's also consistent with the mechanism of relieving checkpoint inhibition in that these kinds of drugs are able to relieve repression of activated T-cells, they are not really intended to activate T-cells that's part of the reason that we think that we have such good therapeutic index, certainly with the oral small molecules as well. Having said that as we indicated majority of our data in the in vivo activity models indicate that the drug is somewhere active in the 10 mg per kg dose level whereas in the safety models we have taken the drug all the way up to 1000 mg per kg per day administration and has remained safe. This does allow us to initiate the Phase 1 trial at a comfortable dose one that we think based on calculation should result in repression of the immune activation but again the first study in patients in the Phase 1 trial will be a dose escalation, will start at a healthy dose for the patients but we will see as we go. First safety, first and foremost but as we escalate we will do both evaluation of the biomarkers that we intend to look at and of course any of the clinical activity that may emerge as part of the study. So I couldn't exactly tell you Adnan which dose or which cohort we expect to see it, we just feel as if that starting dose should be a good dose for the patients, we will look at safety first and then expect to see both immune activation and hopefully benefit for the patients in clinical form soon as well.

In terms of update would be just hear that it's moving from cohort one to two to three or you would be able to update on activity at some point?

I think the later Adnan, I don't think this is the case where every dose cohort we would make an announcement that we have gone to the next cohort. I think, we better think for the shareholders and for the drug candidate is allow us to experience how to actually give the drug. Our expectation is overall daily dosing and it continues those escalations, but these things yet we have to go into the clinic first and get that experience before we come out and describe what types of activities and safety and everything else that we think so. I doubt that we will do this cohort by cohort.

Thanks. If you can just let me ask Mike a question since this is his farewell call. Hi Mike, so does guidance assume exercise of any future programs from Aurigene and that's it? Thanks.

Yes, the guidance assumes exercise of one future program in immune-oncology which is a $3 million option exercise in 2016.

Okay thanks.

Thank you. Our next question is from the line of Joe Pantginis of Roth Capital Partners. Your line is open.

Hey guys good morning, thanks for taking the question and Mike good luck on your future plans as well. So Ali first, with regard to one, I am sorry, 907 you said Phase 2 status update, can you be a little more granular on that if you can, I mean, with regard to potential data updates at say major medical conferences?

We certainly, obviously the ASH would be an idea of timing for us to present the abstracts and do for a period of time. We would certainly like to update at the ASH conference anything that we observe noteworthy wise for Phase 2, but certainly we would be wanting to update on the finality of Phase 1 trial, there are still patients ongoing in the Phase 1 trial in particular patients in the combination with rituximab expansion arm, but it’s still ongoing. So likely that we will present at ASH again not committing right now just because the abstracts aren’t quite due yet, but certainly ASH can be a conference for CUDC-907 for us.

Well that's helpful thanks. And if I can just focus one quick question and a little more broader question on the Aurigene collaboration, first on 4948 do you have specific plans yet or are you in wait and see mode with regard to moving into inflammatory indications?

Our expectations are and where we have been looking at this star candidate and has been in hem malignancies, lymphomas are certainly an area these are malignancies including the DLBCL are an area that we would like to look at as well as other hem malignancies. But it will be predominantly hem malignancies that we will be looking at with CA-4948.

Not sure understood and I guess the broader question with regard to 170 or even just compounds coming from the program as you look to a lot of your pre-activities before getting into the clinic in identifying sites and such activities, could you describe the type of feedback you have been getting from the sites with regard to the general views towards having an oral immunotherapy compound since all the focus is on the biologics right now?

Yes, I can tell you that there is high interest both in the concept of taking an oral small molecule from multiple centers that David has been in discussion with and investigators that would very much like to take this drug into the clinic for testing in their patients. There is also level of excitement for taking a drug with this profile, target profile in particular for dual targeting of PDL-1 as well as VISTA. Both of those seem to be very attractive for investigators, the fact that it's an oral inhibitor as well as the opportunity to target these particular checkpoints has been of excitement. David has been in discussion with multiple centers, several of which we will be entering and enrolling patients in the Phase 1 trial.

Thanks a lot guys.

Thanks Joe.

Thank you. Our next question is from Boris Peaker of Cowen, your line is open.

Great, thanks for taking my questions. So first maybe on 907, do you have a sense of what or how frequently this alteration, MYC alteration is found, have you done or do you plan to explore various tumor type to just kind of get a sense of the landscape?

Sure. As I mentioned at least what’s published in the literature with respect to MYC alteration in diffuse large B-cell lymphoma which is the fairly common occurrence up to 19% of patients have gene trans-locations of MYC and roughly third or so patients with diffuse large B-cell lymphoma have up regulation of the protein. As I mentioned there is an amount of overlap associated with that meaning many patients that have trans-locations have MYC protein up regulations that's obviously the driver, the protein being the driver in this case. With regards to other malignancies, in solid tumor we predominantly find gene amplifications increasing copy number with respect to MYC. NMC disease is an interesting one simply because that's where we find higher expression of MYC. In other solid tumor cancers higher prevalence of MYC trans-locations appear to occur in patients with triple negative breast cancer for example, sub-populations of patients with colorectal cancer and hepatocellular cancer. And then as I mentioned a few different pediatric cancers and in particular meduloblastomas they are driven by [semec] amplifications, high percentage of them especially the prognosis group or the highest risk group. And then, a significant portion of patients, pediatric patients with neuroblastoma that are driven by [indiscernible] amplification. I hope that answers your question in the DLBCL obviously where we have majority of our data and up to a third of those patients are thought to be altered for MYC in one form or another.

Great, yes now that answers the question. So one of my other question is for Mike in your last call, I just want to get a sense of what’s the timeline for pain off the royalty debt?

2019 is what we are currently forecasting.

And the partnership will end…?

The composition matter IP goes to late 2020s, end of 2028 so there is a lot of royalty life after the debt is repaid.

Got you, alright thank you very much for taking my questions.

Thanks Boris.

Thank you and that does conclude our Q&A session for today I will now like to turn the call back over to management for any further remarks.

Yes, thank you and lastly I would like to extend the thank you to all the employees of Curis for their hard work and bringing our programs to the state that they are in and allowing us to progress the company to one that is focused on developing effective drugs for patients with cancer and our eventual goal of commercializing some of these drugs. I would also like to thank all of the patients and their families who participated in our trials and make these studies and analysis possible. And lastly again, I would like to thank all of the hard work that Mike and Jay have done for the company to bringing us to this stage as well. Thank you.