Good afternoon and welcome to the Cerulean First Quarter 2015 Conference Call. This call is being recorded. My name is Nicole and I will be your operator today. With us from the company are Paul Friedman, Executive Chairman; Chris Guiffre, President and Chief Operating Officer; and Alejandra Carvajal, Vice President and General Counsel. Now, I’d like to turn the call over to the Cerulean team, Dr. Friedman. Please proceed.

Okay, thank you Nicole for the Cerulean team. Good afternoon, everybody and thank you for joining Alejandra, Chris and me for this call. As you know on March 20 after a thorough search conducted by leading executive search firm, which helped us evaluate external candidates as well as an internal candidate, the Cerulean Board of Directors unanimously elected Chris Guiffre as Cerulean’s new CEO. He is familiar to all of you from his contributions as Chief Business Officer and Chief Operating Officer. So, I am glad to have the opportunity to introduce him to you as CEO, Chief Executive Officer, and to turn this call over to him. Chris?

Thank you, Paul. As you know, our team is passionate about helping people living with cancer. And I am honored to have the opportunity to lead that team in the pursuit of its important goals. I also want to thank you Paul for your leadership and mentorship and for agreeing to remain in the capacity of Executive Chairman until the 2016 Annual Meeting. It’s really exciting to conduct my first quarterly call as CEO. So, let’s dive in. Today, I will update everyone participating on the call regarding key activities in the first quarter and provide a brief financial update. Then Paul and I will take your questions. Before we begin, I will ask Alejandra to comment on forward-looking statements that maybe made during this call. Alejandra?

Thanks, Chris. Certain remarks that we make during this call about the company’s future expectations, plans and prospects constitute forward-looking statements for purposes of the Safe Harbor provisions under the Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by these forward-looking statements, as a result of various important factors, including those discussed in the Risk Factors section of our most recent Quarterly Report on Form 10-Q, which is on file with the SEC and can be accessed on our website. In addition, any forward-looking statements represent our views only as of today and should not be relied upon as representing our views as of any subsequent date. While we may elect to update these forward-looking statements at some point in the future, we specifically disclaim any obligation to do so even if our views change. Therefore, you should not rely on these forward-looking statements as representing our views as of any date subsequent to today, May 6, 2015. Back to you, Chris.

Thank you, Alejandra. We had a great first quarter and these are exciting times at Cerulean. On March 19, we announced that a Phase 1b/2 trial of CRLX101 plus Avastin in patients with metastatic renal cell carcinoma, or RCC met its primary endpoint. This is one of the most important and validating events thus far in the history of Cerulean. These clinical data demonstrate the power of our nanoparticle-drug conjugates, or NDCs, which are designed to one, selectively target tumor cells; two, reduce toxicity by sparing the body’s normal cells; and three, enable therapeutic combinations. Also very importantly, these single-arm data bode well for the randomized trial that we are currently enrolling in third and fourth line RCC. The top line data we reported on March 19 included the following highlights. First, the trial achieved its primary endpoint with more than half of the patients enrolled achieving at least 4 months of progression-free survival, or PFS. Second, the median PFS for this trial was 9.9 months. That’s more than twice as long as the roughly 3.5 months we would expect to see for standard-of-care in this setting. Third, the RECIST response rate was 23%. That’s far more than the 2% to 4% response rate we would expect to see with standard of care in the third and fourth line RCC setting. Finally, consistent with the broader CRLX101 experience in more than 250 patients at this point, CRLX101 given in combination with Avastin was found to be safe and well tolerated in this important Phase 1b/2 study. The full dataset underlying the top line data we announced on March 19 will be presented by Principal Investigator, Dr. Steve Keefe. Keep in mind that patients are still being treated and these data will continue to mature beyond ASCO until there are no…

Thank you. [Operator Instructions] Our first question comes from the line of John Newman of Canaccord Genuity. Your line is now open.

Hi, guys. This is Kevin in for John. Thanks for taking my question. I think that you guys have a pretty good cushion for your RCC data, so congratulations, I am going to ask one on Phase 2, I was wondering if I could talk a little bit about the ovarian and rectal cancer programs you have going on, specifically the enrollments, just want to see how the status is for that because I do know that in rectal cancers it does take longer because patients maybe treated and [indiscernible]. So, just wondering if you have update on the enrollments, how many patients that you guys would think that you guys be presenting and when the data will actually be coming in this year?

Sure. So, first of all, thank you for the compliment we are pleased with the 9.9 months and I agree I think you used word cushion, I do think that we have some cushion there. We will see whether it’s enough of course. You won’t know until the readout of the randomized data about a year from now. But we certainly like the data we are seeing in the Phase 1b/2 study and we are glad that Dr. Keefe is going to present it at ASCO. In terms of your questions about both the ovarian programs and the rectal programs, I didn’t even mention them in my comments today because we had no new clinical data to report. I believe in our last call we guided people to the expectation that by the end of the year we will provide additional interim data. So you may recall Kevin that on the call in March, we provided for the first time clinical data in both of those settings. We had 9 patients worth of ovarian clinical data to report and 8 patients worth of rectal clinical data report. That’s obviously too small a sample size to draw significant conclusions. So, we told people we will continue to enroll those studies and we continue to expect to provide data by the end of the year on those studies, which could help facilitate go, no-go decisions. With that said, you made a comment about the pace of enrollment and I am glad you highlighted that. There are many, many benefits associated with working with leading academic institutions on ISTs, not the least of which is their expertise. The fact that they are paying using their money to study our drug is also quite helpful when you are a small company like ours, but one of the prices you have to pay when you do that is that you are not able to control the pace of enrollment quite as much as you would like. And I think I have said publicly before that I would have preferred to have more data than 8 and 9 patients respectively on each of those trials to report. We continue to enroll those trials. They never enroll fast enough for me, but we do think we will have a meaningful body of data by the end of the year. I just think it’s not wise for me to speculate on what the exact number is in either program, but you have seen that we have 8 and 9 patients after almost a year of enrollment for each study. We are hoping we can pick up the pace on that, but you should not be expecting 25 or 30 patients at the end of the year that would be a mistake.

Okay, great. Thank you so much.

Okay, thank you.

Thank you. And our next question comes from the line of Mike King of JMP Securities. Your line is now open.

Good afternoon, guys. Thanks for taking the question.

Hi Mike.

Actually a couple that I wanted to follow-up on the previous. On renal, Chris, I wonder – couple of questions I had one is on the randomized trial I think the key focus should be on the hazard ratio more so than absolute level of PFS, correct? So, maybe you can talk a little bit about the hazard ratio you are looking for in case there is a play of chance, where control – we saw this with the Inlyta study, where the control arm did a lot better. So, I am just wondering if you can talk a bit about that kind of hazard ratio you are looking for in the randomized?

Yes. So, there is a limit to how much depth I can go into with you, Mike, but what I can tell you is the obvious answer to your question on the hazard ratio, it’s 0.6. And I agree with you that hazard ratio is important and it’s 0.6 in this study.

Okay, thanks for the clarity on that. Also on just can you remind us what the criteria are for measuring progression, because this is another area where trials can get, can sometimes lose their or reduce their benefit in terms of the drug over control just as far as how the clinicians read progression versus a central lab. And is that different between the open label and the randomized?

Yes, so excellent question. And I think I am going to invite Paul to join me in answering it, but let me start off with a couple of points in response to your question. So, first of all, the measurement criteria, the RECIST criteria which you are familiar with, 20% increase or the 30% decrease and so those are the criteria that are used in both the single-arm study and the randomized study. In terms of the randomized study however, there is independent review of the scans and that is a difference than what you would see in a single-arm study in an IST. So, the University of Pennsylvania is reviewing – is doing its own scans for the IST, but in the multi-center company-sponsored randomized trial, which will have more than 35 U.S. centers and 5 South Korean centers that is all being harmonized through independent review of the scans. And that’s a decision we actually made recently. That’s an additional expense for the trial, but we decided based on the advice from some of our clinical and regulatory advisors that, that was an expense well worth incurring in order to make sure that this trial was well-suited for registration purposes whether it be as one of two well-controlled trials or is the basis for an accelerated approval.

So, I can’t add a whole lot to that, Chris, except to say that I think that, that is an important distinguishing aspect, the fact that we proactively decided to go ahead and spend that money with the idea of having a more blinded, a more certain objective and blinded review of the data. And I think that’s a best practice. I think that was a – it’s money well spent.

Did that help Mike?

It should. And then on ovarian, maybe you can help us put that study result – future study result into context for us, again because I guess Avastin has shown an ability to extend PFS, it’s often difficult to measure in ovarian with just because of the nature of the disease, so what kind of result would be sufficient enough I guess is the question to move forward with 101 in that setting? Thank you.

Yes. Okay, sure. Thanks. So first of all, I will say that when we started the program we used to answer that question by saying we would like to see something north of a 20% response rate, because that is what we viewed as a meaningful improvement over standard of care at the time. But we would also point to people that the AURELIA data where Genentech combined Avastin with three different chemos were worth keeping an eye on, because one of the three of those combinations actually produced some impressive results and that’s Avastin in combination with weekly paclitaxel. To the surprise of some of the thought leaders in the space those data were accepted and reviewed and approved by the agency. I think the approval is right around Thanksgiving. So really what’s going on, we are in the first few months of a potential shift in the standard of care in second and third line ovarian cancer. I think we while we enroll our various trials in ovarian cancer and we have two, we want to see whether or not the market is going to move in the direction of Avastin plus weekly paclitaxel. If you have seen those data and I know you have Mike, you can tell that that significantly moves the needle and we won’t be talking about a 20% response rate as being satisfactory to move forward. So the way I would like to answer your question is to say over the course of this year, while we are enrolling patients in a combo of 101 and Avastin and in a combo of 101 and weekly paclitaxel, we will be evaluating what the bar is that we would want to clear before we would decide whether to invest in an expensive randomized trial. So by the end of the year I might be able to answer your question with a little more specificity, but for now that’s really about all I can say without speculating.

Thank you.

Thank you. And our next question comes from the line of Katherine Genis of Edison. Your line is now open.

Hi everybody. First, Chris congratulations.

Hi, Katherine.

How are you?

Doing well.

Good. Just wanted to congratulate Chris on your new assignment first and wish you with the best and good luck in your new role.

Thank you very much.

You’re welcome. I just had a couple of questions. The first one was in reference to the Phase 1b/2 study and the randomized, could you just talk a little bit about representative patient populations. Are you looking at a very similar patient population in the randomized versus the single arm maybe you could speak to that. And then second, could you just refresh my memory as to any dose limiting impact of the combination of CRLX101 and Avastin?

Sure. So you know what I would like to – I will definitely jump in and just tell you that yes at a high level they are the same patient population. But I will actually turn to my colleague Dr. Friedman and let him and his MD try and answer the rest of the question for you.

If I am correct here, we are only taking third – people who have seen two or three previous regimens where as there were a couple of patients in the 22 who read or layer or earlier. And we are also taking non-clear cell, but we have made the primary analysis of 90 patients who are going to be clear cell. And then there are another 20 who are non-clear that don’t – are not part of the primary analysis, but we were intrigued in the IST study by some interesting responses we got in the non-clear cell patients and that’s an even harder patient population to treat. The second part of the question – the second question had to do with limitations with the dosing combination. I think the combination has been very well tolerated. I mean, if you go above the MTB, you do see bone marrow issues, but if you stay at the 15 mg/m2 in combination with Avastin in the 250 patients that we treated to-date combination has been very well tolerated.

Exactly. Yes, I mean, I don’t know how much more we can awake and answer that question other than to say there have been no discontinuations, no dosing down, tolerability is qualitatively as best as they are well-tolerated. And maybe the best thing we could do is point you to the presentation at ASCO and hope that Dr. Keefe speaks to that in more detail when he gives his presentation or obviously if you are at ASCO, we would love you to come to the reception and hear what Dr. Keefe and Dr. Voss have to say to the group at our reception.

Absolutely. We are looking forward to that. Thank you.

Thanks.

Thank you. That concludes the question-and-answer session. I will now turn the call over to Mr. Guiffre for any closing remarks.

Excellent. Well, thanks to all of you for joining us today and we are looking [Technical Difficulty] next quarter. Have a good night.