Good afternoon, and welcome to the Cerulean Fourth Quarter and Year-End 2014 Conference Call. This call is being recorded. My name is Andrew, and I will be your operator today. With us today from the Company are Paul Friedman, Executive Chairman; Chris Guiffre, Chief Operating Officer; and Ronan O'Brien, Associate General Counsel. Now I’d like to turn the call over to the Cerulean team. Dr. Friedman, please proceed.

Thanks, Andrew, and good afternoon everybody. And thank you for joining Ronan, Chris, and me for this call. Today I'm going to update you on fourth quarter activities as well as recent news including some encouraging interim data in the Phase 2 study of CRLX101 in renal cell carcinoma that we reported this afternoon. And Chris will provide an update on the team financial matters and milestones. And finally, we will answer your questions. Before we begin, I'll ask Ronan to comment on forward-looking statements that may be made during this call. Ronan?

Thanks, Paul. 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 Annual Report on Form 10-K, 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 March 19, 2015. Back to you, Paul.

Thanks, Ronan. As many of you know Cerulean’s nanoparticle-drug conjugates or NDCs consist of potent anti-cancer payloads chemically conjugated to the nanoparticle, which are designed to selectively target tumor cells, reduce toxicity by sparing the body’s normal cells, and enable therapeutic combinations. We’ve two such NDCs in the clinic, the first being CRLX101, an NDC with camptothecin as its payload, whose anti-tumor activity is driven by its durable inhibition of two important cancer targets, topoisomerase 1 or Topo 1, and hypoxia-inducible factor-1 alpha or HIF-1 alpha. CRLX101 is being studied in combination with other cancer treatments in free tumor types, renal cell carcinoma or RCC, ovarian cancer and rectal cancer. As we reported this afternoon in a Phase 1b/2 trial in relapsed RCC conducted by the University of Pennsylvania. CRLX101 in combination with Avastin met its primary endpoint with more than half of the patients enrolled achieving at least four months progression-free survival. The Principal Investigator, Dr. Steve Keefe has submitted a full data from this trial to ASCO for presentation, but we're announcing top line data today. Importantly as of the ASCO submission, median PFS for this trial was a notable 9.9 months. That's more than twice as long as the roughly 3.5 months we’d expect to see for standard of care in this setting. The RECIST response rate at the time of the ASCO submission was 23%, and that's also a marked improvement on the 2% to 4% response rate that we would expect to see. And seven of the 22 patients enrolled on the trial remain on treatment. And importantly 101 was found to be generally well tolerated. I would like to remind you that while these data are encouraging, they continue to mature. Therefore while the primary endpoint of this study has been achieved, and the…

Thank you, Paul. The clinical development program for CRLX101 continues to expand. In addition, we put our second platform generated candidate CRLX301 in the clinic at the end of last year. With so much clinical development going on, it was important for us to add a seasoned professional to our management team to run our clinical operations. Tiffany Crowell joined us as Vice President of Clinical Operations in January. And she brings deep, clin ops experience. Tiffany’s experience running clinical trials at AVEO, Inotek, Vertex, and Therion will serve her well as she manages our growing portfolio of clinical trials. Tiffany completes our post-IPO management team mansion that also includes Alejandra Carvajal, our General Counsel and Pam Strode, VP of Regulatory Affairs, both of whom we announced joined us in the fall. Now I'll turn to a quick financial update, and a summary of upcoming milestones. Then Paul and I will take your questions. Here is a brief highlight of our financial results for the fourth quarter of 2014, which are included in the Annual Report on Form 10-K that was filed earlier this afternoon. For the fourth quarter, we had a net loss of $7.5 million compared to a net loss of $3.5 million in the fourth quarter of 2013. And a net loss of $23.3 million for the full-year of 2014 compared to a net loss of $17.1 million for the full-year of 2013. The increase in net loss for the 2014 period was due principally to expenses associated with the initiation of the randomized Phase 2 trial in RCC and the incremental expense associated with operating as a public company. Importantly, we ended the fourth quarter with cash and cash equivalents that totaled $51.2 million. In January 2015, the company also entered into a loan and security…

[Operator Instructions]. And the first question in the queue today is from the line of Mike King from JMP Securities. Your line is open.

Thanks for taking the questions, guys, good afternoon, and congrats on the encouraging results. Just a couple of quick follow-up questions on the RCC study. Just remind us, clinicaltrials.gov listed an enrolment goal of 22, is that correct? Is that the correct size of the study?

That is the correct number of patients. 22 patients in the IST that will be presented at ASCO. That's different obviously than the randomized trial which is a 110 patients.

Yeah, okay, great, just wanted to be clear on that. And then can you say anything about --

The next question is from the line of Michael Schmidt from Leerink Partners. Your line is open.

Hey, good afternoon, and congrats also from me on the RCC data. I was wondering so at ASCO, will the data be mature enough to have a first look at overall survival?

I mean, I would think there might be -- I doubt that we would have a full overall survival set by ASCO. But I think that probably wouldn't be that helpful.

Yeah, it’s a good question. I agree with Paul, but I don't think we actually know the answer. Remember this is an IST, so they are not our data. Dr. Keefe is the one who prepared the abstract and submitted it, and he will be the one who has the final say on what goes in his poster.

And then on the ovarian cancer study, so you reported one of nine responses, I guess it still tracks a bit below your sort of target of 20%. How many more patients are you planning to enroll in this Avastin combination study, number one? And number two, is there a mechanistic rationale to combine 101 with paclitaxel or is it simply the best possible combination in this line of therapy?

So indeed, there are a number of intriguing aspects. I'll take the second part first to combining paclitaxel with weekly administration with 101. We’ve seen good synergy in animal models giving the two drugs together. There is existing data and we’re in the process of developing more for weekly paclitaxel, most likely by virtue of damaging the endothelial cells in the tumor, of having anti-angiogenic activity which would play to the strength of the mechanistic idea of HIF inhibition helping efficacy for any angiogenic agent. So we like that, we also like the fact that paclitaxel is such an accepted agent used in the ovarian metastatic patient population, and also the fact that it worked the best in the combination studies, in the AURELIA study. With respect to your first question, currently I believe we are planning to keep that study open in parallel to the GOG study. And we’ve not determined a specific end that where we would cut the study off.

Yeah, so I think during the course of this year Michael, we want to make sure that we get data for both combinations before we decide what is the best path forward for a randomized study. And by the end of the year or early next year, we’re hoping we have enough patients in each of those studies to make a very informed decision.

And then last question, I noticed an abstract at AACR for CRLX101 in breast cancer. And I was wondering you know if you had any additional plans in breast cancer for the agent, may be or within context of the recent [Nektar] [ph] results?

Yeah, so you are correct. That is one of the presentations that will be about 101 at AACR, and we’re looking forward to that. In terms of future indications for the development of this drug, we’ve not commented publicly on what the next indication will be. As you know very well because you are very familiar with this drug, one of its advantages is that it is theoretically a pan-tumor product candidate. Meaning, because we target the leaky vasculature that's present in all solid tumors, we have a wide range of opportunities to choose from. The challenge we have is not that we don't have enough opportunities to pursue. It’s that we have too many to pursue with the resources we have at this point. So which indication will be prioritized next is an open question. I honestly do not know the answer today. I am not being coy, I don't know which one will be next. But we won’t be commenting on which will be next until we are ready to formally announce that it’s our next indication.

Thank you. Our next question in the queue is from the line of John Newman from Canaccord Genuity. Your line is open.

Hey guys, this is Kevin in for John. Congratulations on the progress. The first question I have is I just want to clarify, your current renal cell carcinoma update so is that including the total 22 patients that you guys have right now?

Yes. It is the status of the 22 patients at the time that the abstract to ASCO was submitted, which was in the beginning of February, right.

And to put that in context, when we went public we had interim data on that trial. We had 11 of those 22 patients. Those are the data that are included in the S-1 for our IPO, so now this is the full 22.

I was wondering if you could give me a little color on these patients. I was wondering if you could tell us a little bit if they previously were treated with more TKIs or mTORs. The reason why I ask this is because we know mTOR is also HIF-1 inhibitor, so I was just wondering what these patients actually look like.

Yeah, so I don't have the specific numbers for you at my fingertips and I apologize for that. But I can tell you considerably more treatment with TKIs than mTORs. So the most common drug used in the treatment paradigm that we see wherever we look for RCC is that [Sutent] is often used in 1st line. I won't say it's universally used in 1st line, but I think all or most of the -- almost all of the patients, the 22 patients would have seen [Sutent] in the 1st line. I think your question points to the diversity of treatments that exist in the 2nd line. And there I can tell there are plenty of docs that will use another TKI in the 2nd line. Axitinib is often used, and there are some docs who will use one of the two mTORs in 2nd line. But there is probably not -- there is a little more heterogeneity in the 2nd line treatment than there is in the 1st line treatment. But I think an important part of our thesis here is that once you get through those first two lines, you have exhausted the two classes that are available. And when you go into 3rd line, we are creating a new option for these patients. So not a recycled TKI, which we do not think is beneficial to the patients, and not a recycled mTOR, but a new class. And that's why we are so excited about the promise of this randomized trial.

Moving to ovarian cancer. I was wondering if you could tell us a little bit about those patients as well. So given the fact that, were they mainly platinum-resistant or platinum-sensitive or did they just not respond to initial therapy in the first place?

Yeah, so I'm going to make sure that I clarify this answer by introducing another piece of data into the mix. You're not asking about the patients who are treated in the 29 patient monotherapy study at the Harvard teaching hospitals. Those patients we announced we met the endpoint in that study more than a year ago I believe. Those patients were a mixture of platinum-sensitive, platinum-resistant and platinum-refractory, although most of them were platinum-resistant. In this study that we are running now at the same four Harvard teaching hospitals, we are combining with Avastin and we’re treating only platinum-resistant patients.

And just one more question on the rectal cancer. I was wondering what is the timeframe after you are giving treatment that the pathologic response was actually a [success]. And do you guys think that if pathologic response effects was a little bit longer or shorter, would that difference in response actually be seen?

Well pretty much. I think pretty much they get their treatment regimen, and then they go to surgery and it's about a 14-week period from start to finish, and then the histo path is looked at, at that point to determine the scoring, and how many have shown no residual nested tumor on extensive histopathological examination.

Thank you very much. And our next question is from Mike King from JMP Securities. Your line is open.

One of the questions, the follow-up questions was answered on the RCC study. But just curious, in regard to the prior therapies was it required to have both TKI and mTOR, as previous therapy before admission to the trial?

No.

It was not, okay. I guess it was just assumed that the patients would have some mix of standard of care?

Correct.

Okay. Can you also say how many patients remain on drug if any?

Of the 22 patients, seven remain on treatment.

And then thirdly, I am just wondering if you could help us, I think one of the concerns one typically has when you get a result from a small, you know a Phase 1-2 trial especially one that's run at a single centre is about generalizability to larger randomized studies. And you’ve obviously got a lot of PFS to play with. But I'm just wondering if you could help us get our head around the comparability of the patients in the Penn study versus the randomized trial?

So I think your point is very well taken, that small single center studies can be occasionally misleading with respect to larger studies. I don’t think that’s going to be the case here. I think we specify in the randomized trial that you have to be 3rd and 4th line, and that's it. I think there may have been one or two people in the 22 who was not 3rd or 4th line. But your point is well taken, also your point about we’ve significant amount of PFS to play with. I think it's an important point, because we have in the randomized trial 80% power to detect our target of a 2.3 month improvement in PFS over standard of care of 3. 5. Which I think if you add up is about 6.8, is it right. 5.8, and we are currently sitting in an interim look at data from the 22 patients at 9.9. So even if that 9.9 came down a bit, we still would be well above what we would need for statistical significance in the randomized trial with the 80% power that we’ve put into the trial.

You know, it doesn't change your point at all, Mike. But just as a technical point, it actually started out as a single center study. But then in an effort to try and pick up the pace of enrolments, U Penn actually did bring Thomas Jefferson University Hospitals in. And so there are two sites, but it doesn't change your point. And I think that we think it's a representative population, but we won't know until we read out on the randomized trial. And that's why we’ll run the study.

And then just a quick question on rectal, the neoadjuvant. Patients in that study will be followed for overall survival?

No, I mean we'll -- I'm sure we'll learn something over time about what happened to them. But you know at the moment it’s just -- you're talking about the eight or nine that we currently have I think.

Correct.

Sure, we'll hear whatever we hear from them, but it’s [certainly].

Yeah Mike, I mean remember in this setting these patients are tracking disease-free survival like five years out. So I guess I wouldn't be holding your breath waiting to hear about the disease-free survival stats on this trial. We'll make our decision on a go no-go for a randomized trial, long before we have any disease-free survival data to look at.

That concludes the question-and-answer session for today. I'll now turn the call back to Dr. Friedman for closing remarks.

Sure, thanks for joining us today and we look forward to reporting on continued progress next quarter. With that, we'll end the call. Good night.