Cellectar Biosciences Inc (CLRB) 2014 Q3 法說會逐字稿

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 will conduct a question-and-answer session and instructions will follow at that time. (Operator Instructions). As a reminder, this 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 the US financial markets and our press release can be found on our website at www.Cellectar.com.

Joining me from Cellectar is Dr. Simon Pedder, our Chief Executive Officer; Chad Kolean, our 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 you will hear today may contain forward-looking statements about the Company's performance. We may also make forward-looking statements during the Q&A 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 differ materially from those in these forward-looking statements is contained in our filings and periodic reports filed with the Securities and Exchange Commission, copies of which are available on our website or may be 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. As 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 in 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 leads 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 that the cost of the capital was high and that it 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 are delivering on our objective. We remain committed to controlling our expenses and are making progress in our three core programs, each 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 in 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 Veterans 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 ended 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 the necessary capital that you 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 room.

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 $3.0 million per quarter through the end of the year. And that should remain remarkably consistent throughout 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 a cover story for the June 11 edition of Science Translational Medicine. I am pleased that just a few months later our technology was once again featured in a 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 continue to do groundbreaking research with our platform and product candidates.

Translating this body of work into manuscripts for publication has the potential to dramatically improve awareness of and interest in our technology, product candidates, and Company-sponsored clinical trials both from 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 from nonmalignant tissue and highlighting regional lymph node.

By effectively eliminating malignant tissues, the office indicated that CLR1502 might enhance the ability to properly resect these type of cancers through better localization of the primary tumor, use of real-time illumination of the tumor as a surgical aid, and improve lymph node identification.

Not only am I pleased to see continued progress in our publication strategy and would like to thank each author for their contribution and support but I am also of course excited by further evidence supporting the broad utility of our platform technology and potentially groundbreaking applications of a true cancer-specific optical imaging agent. It is a timely reminder of the unique capabilities of this agent as we've prepared 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 surgery 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-site trial in approximately 20 patients undergoing lumpectomy in which we hope to establish the safety, determine image-sensitive dose levels, and characterize a sensitivity and 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 radiopharmaceutical candidate, I-131 in patients with relapsed or refractory multiple myeloma. We are currently working with the principal 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 the next 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 relapsed or refractory multiple myeloma who have previously been treated with or intolerant of an immunomodulator or 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 the overall response rate, time to progression, and the duration of the 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 slower 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 called for a prespecified dosimetry evaluation following the first three patients. As no safety concerns were observed and the completion of the evaluation delayed the initiation of new clinical sites in the program, we have modified our protocol to remove the second planned dosimetry evaluation in order to facilitate site participation and continued enrollment. We have already seen the benefit of this protocol change in the rate of site initiations. We are 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 a Q&A session, I will ask Jamey to briefly introduce an exciting new research initiative at Cellectar. Jamey?

Thanks, Simon. As we remain 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, a sister compound to our florescent optical imaging agent, CLR1502. Because of their optical properties in the cancer selectivity and we have seen pre-clinically with both CLR1501 and 1502, we think they may make ideal agents 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 breasts, prostate, and colorectal cancer.

To evaluate the potential of 1501 and 1502 to identify and quantify CTCs in a minimally invasive manner, we are initiating a small pilot study in treatment-naive advanced 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 in co-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, Jamey. As I hope is evident, we have 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, our 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, full treatment of multiple myeloma and CLR 1502 for real-time optical imaging and breast cancer surgery on the horizon we believe this is the 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). I am not showing any questions on the phone lines at this time. I would 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 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 goodbye from Cellectar.

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