Kathryn McNeil - VP of IR Simon Pedder - CEO Chad Kolean, CFO Jamey Weichert - CSO

Good day ladies and gentlemen and welcome to the Cellectar Third Quarter Earnings Call. At this time all participants are in a listen-only mode. Later we’ll conduct a question-and-answer session and instructions will follow at that time. (Operator Instructions) As a reminder, the conference call is being recorded. I would now like to introduce your host for today’s conference Kate McNeil, Vice President, Investor Relations. Please go ahead.

Thank you. Good afternoon and welcome to Cellectar Biosciences' third quarter 2014 conference call and webcast. We announced our third quarter financial results this afternoon just after the close of U.S. financial markets and our press release can be found on our website at www.cellectar.com. Joining me from Cellectar today is Dr. Simon Pedder, our Chief Executive Officer; Chad Kolean, Chief Financial Officer; Dr. Jamey Weichert, our Chief Medical Officer; Dr. Kevin Kozak, our Chief Medical Officer. I'm sorry Jamey. Jamey is with us, our Chief Scientific Officer. Before I turn the call over to Dr. Pedder, let me note that some of the remarks that you will hear today may contain forward-looking statements about the company’s performance. We may also make forward-looking statements during the question-and-answer session following our prepared remarks. These statements are neither promises nor guarantees and there are a number of risks and uncertainties that could cause actual results to differ materially from those set forth in these forward-looking statements. Additional information concerning factors that could cause actual results to materially differ from those in these forward-looking statements is contained in our filings in periodic report with the Securities and Exchange Commission, copies of which are available on our website or maybe requested directly from the company. Forward-looking statements are made as of today’s date and we do not undertake any obligation to update any forward-looking statements. With that said, I will now turn the call over to Dr. Simon Pedder.

Thanks, Kate and thanks everyone for joining us this afternoon. We always we welcome the opportunity to touch base with our shareholders, share the progress we have made during the quarter and ensure we keep everyone updated and our expectations for the coming quarters. Following our prepared remarks we will take some time to answer any outstanding questions. While we continue to make progress in each of our clinical development programs, our defining achievement during the quarter was unquestionably the completion of our underwritten offering that generated gross proceeds to the company of approximately 13.5 million, which allowed us to eliminate the debt issued in February of this year and enabled us the listing of our common stock on the NASDAQ capital market. As Chad will address in his discussion, even after deducting expenses related to the offering this leaves us in a substantially stronger position than the 2.4 million we started the year with, and will enable us to pursue our planned development programs. That said, we are aware of the cost of the capital was high and that is our responsibility to be judicious in our spending and focus our efforts on those programs that can deliver a significant return to our shareholders and move us closer to the commercialization of our product candidates. In this regard, I believe, we were delivering on our objective. We remain committed to controlling our expenses and are making progress in our three core programs, which of which has potential on a standalone basis to dramatically increase the value of the company. Before we run through each of these programs individually, I will ask Chad to provide us with a brief overview of the financial results reported for the quarter and provide an update and our financial guidance. Chad?

Thank you, Simon. As Kate indicated, we issued a press release this afternoon, highlighting our financial results for the quarter ended September 30, 2014. Given the Veteran's Day holiday, we plan to file our 10-Q with the SEC first thing tomorrow morning and it will also be available on our website. To recap, we entered the quarter with 11.6 million in cash and cash equivalents, as compared to 2.4 million in cash and cash equivalents at December 31, 2013. As you know, this is a result of having completed an underwritten offering, resulting in gross proceeds of approximately 13.5 million during the quarter. After deducting expenses related to the offering, net proceeds to the company were approximately 11.9 million. In addition to bringing then necessary capital, that should provide us with funding into the fourth quarter of 2015, the offering also allowed us to eliminate the debt that we issued earlier this year by allowing those shareholders that provided us with bridge funding to exchange their convertible debentures for shares and warrants on the same terms offered to buyers in this round. So for the quarter ended September 30, 2014, we reported a net loss of approximately 0.5 million or $0.10 per share. This compares with a net loss of 1.3 million or $0.46 per share reported for the comparable period in 2013. For the first nine months of 2014, we reported a net loss of 5.5 million or $1.54 per share compared to a net loss of 6.8 million or $2.47 per share for the same nine-month period of 2013. Research and development expenses for the quarter ended September 30, 2014 were 1.5 million, as compared to 2.1 million for the third quarter of 2013. For the nine months ended September 30, 2014, our research and development expenses came in at 4.6 million compared to 5.3 million during the first nine months of 2013. Our general and administrative expenses were essentially unchanged year-over-year with third quarter G&A expenses totaling 0.8 million for both periods. Similarly G&A expenses for the nine months ended September 30, 2014, were 2.8 million as compared to 3 million for the comparable period in 2013. Looking ahead we expect our full year 2014 R&D expenses to be between 6.5 million and 7.5 million, and full year G&A expenses to be between 3.5 million and 4.5 million. We continue to expect our quarterly burn to remain between 2.5 million to 3 million -- 3.0 million per quarter through the end of the year and that should remain remarkably consistent through our 2015 as well. With that I will turn the call back to Simon.

Thanks Chad. On our last call, I had the opportunity to highlight a publication by Jamey and his colleagues. That was chosen as cover story for the June 11 edition of Science Translational Medicine. I'm pleased that just a few months later our technology has once again featured in prestigious publication. Getting the word out, so to speak, has been a strategic priority for us. One of those significant advantages of our pipeline continues to be the extensive work that has already been completed and the number of investigators that are continuing to do ground breaking research with our platform and product candidates. Translating this body of work into manuscripts for publication has the potential to dramatically to improve awareness of and interest in our technology, product candidates and company sponsored clinical trials, both from a potential clinical investigators and potential partners. Last month a paper detailing the efficacy of our agents in detecting colorectal cancer was published in the peer-reviewed journal PLOS ONE. While the paper reports the efficacy of both our therapeutic I-131-CLR1404 and our optical imaging agent, CLR1502 in selectively identifying and accumulating in colorectal cancer. The focus of the discussion centered around new data showing CLR1502 accumulating in intestinal tumors, distinguishing malignant form non-malignant tissue and highlighting regional lymph node. By effectively eliminating malignant tissues, the offers indication that CLR1502 might enhance the ability to properly resect these types of cancers through better localization of the primary tumor, use a real-time illumination of tumors as a surgical aid, and improved lymph node identification. Not only I'm I pleased to see continued progress in our publication strategy and would like to thank each offer for their contribute and support, but I'm also, of course, excited by further evidence supporting the broad utility of our platform technology and potentially ground-breaking application of a true caner specific optical imaging agent. It is a timely reminder of the unique capabilities of this agent as we prepare to initiate our first company-sponsored clinical trial of CLR1502 in breast cancer surgery. I think we can all intuitively understand the immediate benefit of accurately illuminating cancerous tissue during any surgical resection. However, we are particularly excited to be studying CLR1502 in breast cancer surgeries first. With nearly one in four breast cancer surgeries repeated due to a failure to achieve clear margins during the initial resection, we believe there is a clear opportunity for an agent that can enhance the accuracy of this surgery and assist surgeons in identifying regional lymph nodes. We continue to anticipate our filing of our IND for this indication before the end of the year and look to get that trial underway in 2015. This will be a dose ranging multi-side trial on approximately 20 patients undergoing lumpectomy in which we hope to establish the safety, determined image sensitive dose levels, and characterize the sensitivity specificity of CLR1502 in identifying malignant tissue. As much as we look forward to getting our CLR1502 program up and running next year, we have momentum in our therapeutic program that is getting us all quite excited. As we announced a few weeks ago, we have received FDA allowance to begin a therapeutic trial of our radio pharmaceutical candidate, I-131 in patients with relapsed or refractory multiple myeloma. We're currently working with the principle investigator of this study, Dr. Natalie Callander and the associated radiation safety specialists to conduct staff training and initiate our first clinical trial site. Based on these efforts, we currently expect to begin enrolling patients in month or so. Additional centers are scheduled to be online and recruiting in the first quarter of 2015. The Open-Label trial will evaluate I-131 in approximately 20 patients with relapse or refractory multiple myeloma who have previously been treated with or intolerant of an immunomodulator and a proteasome inhibitor. The primary objective of the study is to determine the safety and tolerability of I-131 with and without concurrent weekly dexamethasone. In addition, we will also be seeking identification of the recommended Phase 2 dose and determine the therapeutic activity of I-131 in this patient population as measured by overall response rate, time to progression, and duration of response. Finally, a brief update on our most advanced program, our PET CT imaging agent, I-124. While we continue to make progress in this program, it has been slow than originally anticipated and over the last several months, we have been conducting a review of the protocol and our clinical operations to identify areas which we can improve on the execution of this trial. As you recall from our discussion during last quarter's conference call, the initial design of our Phase 2 glioblastoma imaging trial call for a free specified dosimetry evaluation following the first three patients. As no safety concerns were observed in the completion of the evaluation delayed the initiation of new clinical sites in the program, we have modified our protocol to remove the second plan dosimetry evaluation in order to facilitate site participation and continued enrolment. We've already seen the benefit of this protocol change in the rate of site initiations. We're still planning to have approximately 10 centers participate in the trial and with the recent protocol amendments expect topline results from this trial to be available in the first half of 2015. Before we turn the call over to the operator for Q&A session, I will ask Jamey to briefly introduce an exciting new research initiative at Cellectar. Jamey?

Thanks Simon. We remained focused on the execution of our clinical programs. We continue to evaluate new opportunities to further explore and characterize our technology, both in collaboration with independent investigators and in our own company-sponsored research. Specifically, we have begun looking more closely at potential applications of CLR1501, the sister compound to our fluorescent optical imaging agent, CLR1502. Because of their optical properties and the cancer selectivity and we've seen preclinically with both CLR1501 and 1502, we think they may make a deal agent for quantifying, Circulating Tumor Cells Ex VIVO, and potentially provide prognostic information. Circulating Tumor Cells or CTCs for those of you, who may not be as familiar, have been the focus of intense research over the last decade or so. However, efforts to use CTCs as a minimally invasive biomarker have been limited by technical challenges. CTCs are rare compared to the much more abundant Circulating Cells, and distinguishing between the two requires exquisite sensitivity and specificity. Yet the enumeration of CTCs has proven to have prognostic value in breast, prostate, and colorectal cancer. To evaluate the potential of 1501 and 1502 to identify and quantify CTCs in minimally invasive manner, we're initiating a small pilot study in treatment-naive advance cancer patients. This will be a single-center study in which 1501 and 1502 will be used to identify CTCs in blood draws provided before and after treatment. While it is a small inexpensive blood collection study, based on the preferential uptake and retention in cancer cells and COLD culture experiments and animal tumor models, we have seen using 1501 and 1502. We think this pilot study could provide insight as to the potential utility of our technology for CTC identification. Simon?

Thanks. Thank Jamey. As I hope is evident, we’ve been very busy over the past several months, not only securing much needed capital, but also in the execution of our ongoing and planned clinical programs. As we look towards the remainder of this year, we see an increase in clinical activity as we initiate our clinical trial in multiple myeloma, and submit our IND to allow for the initiation of our planned proof-of-concept study of CLR1502 in breast cancer surgery. With the data from our ongoing Phase 2 imaging agent of I-124 in glioblastoma, expected in the first half of 2015 and data from our proof-of-concept trials of I-131 for the treatment of multiple myeloma and CLR-1502 for real-time optical imaging in breast cancer surgery. On the horizon, we believe this is start of a very exciting period for Cellectar, its collaborators, and its shareholders. With that said, Chad, Jamey, Kevin and I would like to open up the call for Q&A. Operator; do we have any questions at this time?

(Operator Instructions) And I'm not showing any questions on the phone lines at this time. I'd like to turn the call back over to Simon Pedder for closing remarks.

Okay. I would just like to thank everybody again for joining us on today's call and that you will -- we hope that you will continue to follow our progress and we look forward to speaking with you again very soon. Have a wonderful evening and good bye from Cellectar.

Ladies and gentlemen, thank you for participating in today's conference. This does concludes the program and you may all disconnect. Everyone have a good day.