Good day, ladies and gentlemen, and welcome to the Curis Inc. Second Quarter 2015 Earnings Conference Call. [Operator Instructions] As a reminder, this call is being recorded. I would now like to introduce your host for today’s conference Senior Vice President of Corporate Strategy and Investor Relations, Mani Mohindru. Please go ahead.

Thank you, Mallory. 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 our second quarter 2015 financial results. Before we begin, I'd like to advise you that this conference call contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including, without limitation, statements related to our strategy, future operations, future financial position, future revenues, projected costs, prospects, plans and objectives of management; the potential therapeutic benefits and our plans to develop our proprietary drug candidates, CUDC-907, progress in the programs under our collaboration with Aurigene, as well as our expectation of our partners Genentech and Roche's continued development and commercialization of Erivedge in various territories. 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 June 30, 2015, that we filed this morning 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 we're making these forward-looking statements only 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 these estimates and expectations to change. I'd now like to introduce Ali Fattaey, our President and CEO, who will provide an update on the Company and the various programs, including CUDC-907, our PDL-1 and IRAK4 Inhibitor programs under our collaboration with Aurigene as well as our partnered program, Erivedge. Following Ali's remarks, Mike Gray, our Chief Financial and Chief Business Officer, will review our financial results for the first quarter 2015, after which we will open the call for questions. [Operator Instructions] Ali?

Thank you, Mani, and thank you to the conference call and webcast participants for joining us this morning. We continued to develop the organization and streamline our efforts to build Curis into an oncology focussed company with strategic emphasis on development and eventual commercialisation of innovative and effective drugs for cancer patients. Let me begin this morning with our most advanced molecule CUDC-907 which is an oral Dual HDAC and PI3 Kinase Inhibitor that is being studied in patients with relapsed refractory aggressive lymphomas and separately in patients with certain solid tumors. We are very pleased with the progress being made with CUDC-907 especially in the setting of relapsed refractory Diffuse Large B-cell lymphoma or DLBCL. In the past quarter, we reported results from the ongoing Phase 1 trial of CUDC-907 at the ASCO Annual Meeting and the European Haematology Association Annual Meeting as well as the presentation at the International Congress on Malignant Lymphoma that was held in Lugano, Switzerland. Now these presentations highlighted that six out of the ten responsive evaluable heavily pre-treated patients with relapse refractory DLBCL experienced objective responses including two patients with complete responses and four patients with partial responses, while two out of the ten patients had stable disease. Three of these objective responses is which included one complete response and two partial responses occurred in patients with transformed follicular lymphoma DLBCL, one complete response was observed in a patient with GCB subtype of DLBCL and two partial responses in patients with unclassified DLBCL. Additionally, one patient with Hodgkin's lymphoma also experienced a partial response. Overall, stable disease was reported in 25 of the 44 response evaluable patients with various lymphomas or patients with multiple myeloma. No new dose limiting toxicities or DLTs were identified and adverse events were consistent with our previous reports…

Thanks, Ali. We reported a net loss of $8.1 million or $0.06 per share on both the basic and fully diluted basis for the second quarter of 2015, as compared to a net loss of $1.9 million, or $0.02 per share on both the basic and fully diluted basis for the same period in 2014. Revenues for the second quarter of 2015 were $2.1 million as compared to $4.8 million for Q2, 2014. The decrease in revenues was primarily due to decrease in license fee revenues due to a $3 million milestone payment that we earned from Genentech during the second quarter of 2014. Royalty revenues recorded on Genentech and Roche’s net sales of Erivedge increased to $2 million in the second quarter of 2015 as compared to $1.8 million in Q2, 2014. Operating expenses for the second quarter of 2015 were $9.5 million as compared to $6.3 million for Q2, 2014. R&D expenses were $5.9 million for the second quarter of 2015 as compared to $3.3 million in Q2, 2014. The increase in R&D expense was primarily due to increase spending on CUDC-907 and preclinical programs under our collaboration with Aurigene. We incurred expenses of $2.7 million and $1.4 million on CUDC-907 for the quarters ended June 30, 2015 and 2014 respectively related to our ongoing studies. Spending of $2.5 million we recorded, spending of $2.5 million on our preclinical programs including a $2 million milestone payment that we made to Aurigene for selection of a third research program under that collaboration. Offsetting these increases, spending on CUDC-427 decreased by $900,000 during Q2, 2015 as compared to the prior year period as we have wound down investment on this program to focus our resources on the development of CUDC-907 in our programs under the collaboration with Aurigene. G&A expenses…

[Operator Instructions] Our first question comes from the line of Adnan Butt with RBC Capital. Your line is now open.

Hey good morning everyone and thanks for taking the question. One on 907 and then the Check-1 [ph] inhibitor program. The pivotal 907, could you comment a bit about how targeted you expect the DLBCL patient population to be formed only and then if so could it expand to a broader population from there and then on the oral check point inhibitor are the GLP talk studies completed and how do you expect safety to start up relative to the anti bodies? Thanks.

Thank you, Adnan. I’ll try and address those two questions for you. Regarding 907 based on what I described today and obviously what we presented. As we indicated DLBCL, even though it’s about a third of non-hodgkin lymphoma, so little more than third of the non-hodgkin lymphomas and it’s an aggressive disease, its not just one disease type itself. Obviously patients can come and be considered as DLBCL, either de novo and those generally are classified as either GCB subtype or ABC subtype of DLBCL. But patients can also be considered DLBCL based on transformation from follicular lymphoma or from other diseases for example include CLL transformation Richter syndrome. So, it turns out to be a relatively complex disease. We had patients that were enrolled in our study, and as I indicated we’ve seen responses now in patients with transformed follicular lymphoma. We’ve also seen in fact their complete response with the patients with GCB subtype of DLBCL and also in unclassified subtypes of DLBCL. And this is where we put our attention to, of course to figure out how we determine a commonality between these and we think some of that is related to the genetic background of the tumors that come in from different types of DLBCL, but then they do respond with CUDC-907. With regards to whether the Phase-II registration directed study itself only focus on a small population and that’s what we are examining right now. We’d like to draw patients from these different subtypes and types of patients and then begin their enrolment and inclusion into this study. With regards to whether later on this can actually expand into additional subtypes or additional types of lymphomas, we certainly believe that would be the case going forward. But right now we’d like to see how we…

Ali, has the company said which target could follow the PD-L1?

We have not disclosed the target yet at this point.

Okay. Thank you.

Thank you. The next question comes from the line of Brian Skorney with Robert Baird. Your line is now open.

Thanks guys for taking my question. I think you’d recently planned to expand 907 Phase-II study with the combination with ritux, I’m just wondering have patients been dosed in combo in that study. And how will data from this combo determine the path forward in the registrational study given kind of proximity between initial dosing and your plans to move forward with registration on directly study?

Thank you, Brian. With regards to 907, as we’ve indicated the expansion on the enrolled patients as monotherapy and yes the expansion cohort that enrolls patients with CUDC-907 with rituximab has enrolled patients and patients have been dosed. So we are continuing to treat DLBCL patients with both monotherapy as well as in combination with rituximab in separate expansion cohorts. With regards to how that translates into the Phase-II trial, as we’ve indicated we do see obviously the benefit that we’ve seen in patients so far has been monotherapy, however that’s not necessarily mean that that’s how patients will continually treated, especially in the relapsed/refractory setting. And this was part of the reason we wanted to include a combination treatments and get some experience with that with rituximab. Whether the study will be -- the Phase-II study will be a monotherapy study or whether it will include combination is really the part of the design that we’re looking at now based on the types of the patients that we are likely to enrolled. And so that’s probably the best that I can describe the analysis for you. And I should also say that its not necessarily that it would be – that the things would not be necessarily mutually exclusive, it is possible that we will continue the treatment of patients with rituximab and its possible that we would actually initiate this study as a monotherapy for the drug as well. It’s just a little bit too early to try and describe all of that at this point.

Got you. Thanks.

Thank you. [Operator Instructions] Our next question comes from the line of Boris Peaker with Cowen. Your line is now open. Please go ahead.

Good morning. Just question on the competitive front, maybe we’ll start with, Novartis recently had hedgehog inhibitor approved. Just curious how you think that may affect the Erivedge market and when the impact will be felt?

Yes. I’ll touch on that immediate. It’s a little bit uncertain, the drug was just approved the Novartis compound. It was approved in the U.S. It was approved for locally Advanced Basal Cell Carcinoma. Only you may recall the Erivedge is approved for metastatic and locally advanced BCC. All I can really say at this point is discussion with Genentech, if they do – they plan for growth, they plan for growth with or without this competing molecule. This is only competing molecule that I’m aware of in the pipeline for Advanced Basal Cell. So, we do continue to expect until unless we see otherwise that there would be continued top-line sales gross with the molecule for Erivedge.

Okay. Also on the Erivedge IPF study, could you -- do you have sense of the timeline exactly on the study which start as well as when we should see data from it?

We don’t have a great. I mean, the sense of timing for start would be sort of end of Q4 or Q1 next year, Q4 or Q1 next year. The prior design was had an endpoint of one year. We need to the see the final design, so unfortunately we don’t have a lot of clarity on that right now.

Great. And my last question is on the PD-L1 oral candidate, what specific data do you anticipate to provide when you make the announcement of that candidate? Is it going to be any kind of specific presentation at Medical Meetings?

Yes. Our expectation is – let me separate the two things. In terms of selection of the candidate, exercising our option and continuing to push forward for initiation of clinical development of it, it’s in term respect separate from scientific presentations. We do expect to do both of those this year. Presentation at scientific conference is coming in the latter half of the year, as well as the exercise of our option to license the molecule and initiate its clinical developments. Both of those are slated for this year.

Great. Thank you very much for taking my questions.

Thank you. Operator The next question comes from the line of Assaf Vestin with Roth Capital Partners.

Good morning. Thanks for taking the question. Just one regarding 427 and 305, you briefly mentioned them in the press release about revaluating your clinical development plans. Could you just clarify what you mean by that? And what would trigger your decision to maybe go back to them and proceed with development?

Sure. I think probably better way to characterizing it, I think, one of the things that we see is with regard to CUDC-907 or immuno-oncology programs as well as the IRAK4 program for the remainder of the year we view that as being the priority for the organization in the clinical development settings. With regards to CUDC-427, we did complete the dose escalation stage of that study and that was conducted in solid tumor patients. Our expectation is that based on our preclinical studies that drug could be potential useful in the lymphoma setting, however we’ve decided not to initiate that and at the moment focus on the initial programs that I described, CUDC-907 or immuno-oncology programs as well as the IRAK4 program. With regards to CUDC-305 as we indicated there has been – we reacquired that program through the debut form [ph] collaboration, based on their decision not to continue development of that in non-small cell lung cancer. There is the potential use of HSP90 inhibitors in other cancer indications and that had been our interest. I think one of things that we’d like to do right now is focus more potentially on a corporate development or business development opportunities with that drug as opposed to development of it internally ourselves.

Got it. Thanks for clarifying.

Okay.

Thank you. And we do have a follow-up question from the line of Adnan Butt with RBC Capital. Your line is now open.

Thanks. Just wanted to know for the oral checkpoint inhibitor did you plan to run these programs in sequence or could you potentially run them in parallel as well for more than one compound. And then one for Mike, does the R&D guidance include any payments to Aurigene? Thank you.

Thank you, Adnan. I can just answer the first part of the question for you. We would – the way that the collaboration and our expectations of, and the working relationship with Aurigene is, there are multiple programs that are ongoing at Aurigene and as they advanced we would exercise the inclusion of the program in the collaboration. And as the compound in that program would progress we would exercise our option to exclusively license it and take it into clinical development? That is completely and purely at the mercy of how the compounds develop and how the programs come forward. So there is the opportunity to parallel develop compounds. There is no reason for sequential. So, as compounds come forward and they show us their data, we would exercise including programs and also as I indicated taking them forward. So there is definitely the opportunity for a parallel development of multiple programs in this regard and there’s no sequentiality associated within that regards.

And Adnan, this is Mike, the guidance includes $10 million in Aurigene payments, milestone payments.

Okay. Thanks.

Thank you. I’m showing no further questions at this time. I would now like to turn the call back to President and CEO, Ali Fattaey. Please go ahead.

Thank you very much. I’d like to thank everyone for being present on the call. I’d also like to thank all of our employees at Curis for their wonderful work advancing our program. And I’d also particularly like to thank our investigators that conduct our clinical studies and all of the patients and their families who were participating in our trial. Thank you very much.