Cellectar Biosciences Inc (NASDAQ:CLRB)
Q2 2014 Earnings Conference Call
August 20, 2014 05:00 PM ET
Kate McNeil - Vice President of Investor Relations
Simon Pedder - Chief Executive Officer
Chad Kolean, Chief Financial Officer
Jamey Weichert - Chief Scientific Officer
Kevin Kozak - Chief Medical Officer
Good afternoon ladies and gentlemen and welcome to the Cellectar Biosciences Second Quarter 2014 Earnings Conference Call. My name is Kate and I will be your coordinator today. 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. As a reminder, the conference is being recorded for replay purposes. I would now like to introduce your host for today’s conference Ms. Kate McNeil, Vice President of Investor Relations. Ms. McNeil, you may begin.
Thank you. Good afternoon and welcome to Cellectar Biosciences second quarter 2014 conference call and webcast. We announced our second quarter financial results this afternoon just after the close of U.S. financial markets and our press release can be found on our Web site 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 Scientific Officer and Dr. Kevin Kozak, Chief Medical 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 SEC, copies of which are available on our Web site 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 made on today’s call. With that said, I will now turn the call over to Dr. Simon Pedder. Simon?
Thanks, Kate and thanks everyone for joining us this afternoon. We are pleased to have the opportunity to share with you some of the recent developments at the Company. Today’s discussion fails long overdue not simply because we are late in hosting this quarter’s conference call as a result of our recent financing, but also because of registration process for the offering had a rather lengthy quiet period beginning with our initial filing in March.
Needless to say, we look forward to updating you on the progress we have made since then and look forward to answering any questions at the end of our prepared remarks. While there was significant progress in all areas of the business over the last several months, there have been two key developments since our last call that I am most excited to share.
First in June, a man who skips and works for well over a year and reflects nearly a decade of work of Jamey and his colleagues, was not only accepted for publication but chosen as the cover story for the June 11 edition of Science Translational Medicine. In this publication, Jamey and his co-workers not only provide a comprehensive review of the unique broad spectrum cancer targeting characteristics of our PLE platform technology, that showcase inherent scope and flexibility of our technology that allows us to leverage a selective uptake and retention properties to create targeted diagnostic in therapeutic agent.
In doing so, Jamey and his colleagues not only underscored the extensive work that has already been done, but speak to the compelling future opportunity in the diagnosis and the treatment of cancer that our technology has. Clearly, we are excited about this publication and certainly the recognition that comes with the acceptance in our top tier journal.
But more importantly we are excited about the opportunity to continue our development of this platform and its associated agents. Of course the clinical development and commercialization of our product candidates acquired capital and this brings me to the second critical development I want to share, and that is the offering we just completed.
As we announced this afternoon we’ve now successfully completed our underwritten offering to generate gross proceeds to the Company of approximately 13.5 million. In addition to bring in and some much needed capital that gives us over year of operating run rate. The offering also allows us to eliminate the debt that was issued in February by allowing those shareholders that generously provided us with reach financing to exchange their convertible debentures.
The shares and warrants from the same terms offered to the BioScience. In addition to the continued and welcome support from existing shareholders in the offering, we were pleased by the quality of investors both interested in our story and taking sizable positions in the Company. While the terms of the offering were tough and the capital requirements and anticipated substantial position to existing shareholders, we believe the additional capital combined with the execution in our clinical program will better position us to deliver the returns warranted by the promise of our technology and we look forward to making the investments valuable one for all.
Before we review development programs in greater detail, I’d like to introduce Chad Kolean. For those who haven’t had a chance yet to meet Chad, he joined us in May, assuming the role of Chief Financial Officer and working with Joanne to transfer this final responsibility from Boston here to Madison. Already well into the registration process and with a critical financing looming, it’s no easy task for a CFO to jump in, get up to speed and manage this critical effort on our behalf.
His ability to do so and do it well gives us all the confidence we made the right hire and we look forward to his continued contributions. Not a least of which being his contribution to this call, as I’ll now ask him to provide us a brief review of the financial results reported for the quarter and provide an update on our financial guidance. Chad?
Thank you, Simon. As Kate indicated, we issued a press release earlier this afternoon highlighting our financial results for the quarter ended June 30, 2014. On August 4, we filed our second quarter 10-Q with the SEC, both the press release and 10-Q filing can be found on our Web site. To recap, we ended the quarter with 1.6 million in cash and cash equivalents compared to 2.4 million in cash and cash equivalents at December 31, 2013.
As you know we’ve just completed an underwritten offering resulting in gross proceeds of approximately 13.5 million after deducting expenses related the offering we expect net proceeds to the Company of approximately 12.4 million. In addition to the cash infusion the offering also allowed us to convert 4 million of debentures we issued in February.
As Simon indicated, the offering will fund our current and planned development programs for over year and provide operating capital into the fourth quarter of 2015. For the quarter ended June 30, 2014 we reported a net loss of approximately 2.1 million or $0.73 per share. This is consistent with the net loss of 2.1 million or $0.72 per share reported for the comparable period in 2013.
For the first six months of 2014 we reported a net loss of 5 million or $1.75 per share to the modest improvement over the net loss of 5.5 million or $2.03 per share for the first half of 2013.
Research and development expenses for the quarter ended June 30, 2014 were 1.4 million as compared to 1.6 million for the second quarter of 2013. For the six months ended June 30, 2014 our research and development expenses came in at 3.1 million compared to 3.2 million during the first six months of 2013.
Our general and administrative expenses were essentially unchanged year-over-year with second quarter 2013 G&A expenses totaling approximately 1.0 million as compared to 1.1 million during the second quarter 2013. Similarly, G&A expenses for the six months ended June 30, 2014 were approximately 2.0 million compared to 2.2 million for the comparable period in 2013.
Looking forward, we see 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 burns remain between 2.5 million and 3 million per quarter through the end of this year with no significant variation to that rate expected in 2015.
And with that I’ll turn the call back over to Simon.
Thanks Chad. I would now like to ask Jamey to provide you with a brief update on our clinical programs. Jamey?
Thanks Simon. During the second quarter we continued to make substantive progress in each of our clinical programs. I’d like to start with our most advanced program, our PET CT imaging agent 124-CLR1404 or as we frequently refer to as simply as I-124. As you know we initiated Phase III imaging trial for I-124 in patients with glioblastoma earlier this year. This trial will compare the efficacy of I-124 compound in accurately detecting glioblastoma with standard of care MRI based on pathology conformation. This trial continues to enroll patients and we’re now ramping up the rate at which we’re adding sites to the trial, we’re still planning to have a total of approximately 10 centers participate in the trial. However, because of a pre-specified dosimetry evaluation following the first three patients, there was a bit of a delay in activating centers until net cohort and dosimetry evaluation had completed and full enrollment could proceed.
As there were no safety concerns imported by this cohort, the study began unrestricted enrollment during the second quarter and we are now looking to expedite the additional remaining trial sites. However, because of this initial delay, we now expect top line results from this trial to be available in first half of 2015. In addition, to making progress in our Phase 2 trial during the second quarter we were successful in obtaining orphan designation for I-124-CLR1404 as a diagnostic imaging agent for the management of Glioma.
This designation was critical both in respect of the seven years of market exclusivity provided to orphan products upon approval but also the advantage as it provides in structuring smaller clinical trials requiring fewer patients to supporting new drug application and allowing for ongoing dialog with and assistance from the agency in designing clinical programs and adequately characterize benefit of a drug in a limited patient population.
The other orphan indication we are pursuing of course is multiple myeloma. As we announced during our last call, we are preparing to initiate a Phase I proof-of-concept trial of our radiotherapeutic I-131-CLR1404 in this indication later this year because of radio sensitivity of multiple myeloma is well documented and data supports cancer specific uptake in retention of our delivery platform in a wide range of malignancies including multiple myeloma. Therefore we believe I-131-CLR1404 may permit targeted delivery of ionizing radiation to myeloma to cells regardless of their anatomic distribution.
In preparation, we recently submitted our Investigational New Drug or IND application to the FDA. Based on a 30 day review requirement for IND applications we anticipate hearing back from the agency by mid September. Our current plan is to conduct the study in approximately 20 patients with relapsed to refractory multiple myeloma who have previously been treated with or are intolerant of an immunomodulator and a proteasome inhibitor.
The primary objective of the study is to determine the safety and tolerability of I-131-CLR1404 with and without concurrent weekly dexamethasone. In addition of course we will also be seeking to identify 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.
As this is study is small and we anticipate initiating patient enrollment late this year, we expect to be able to report top line results from this study by year end 2015.
Finally, though as not, it hasn’t yet generated the same headlines as our PET imaging or therapeutic programs, we continue to make progress in the developing CLR1502 as an optical imaging agent for real time use during breast cancer surgery. As I indicated during the last call, we are undertaking some modest additional pre-clinical work prior to making a formal application to the FDA to conduct human clinical studies. This work is now nearing conclusion and we expect to file an IND later this year which would enable us to initiate patient enrollment early in 2015 as planned.
This will be dose ranging multi-site trial on approximately of 20 patients undergoing lumpectomy in which we hope to establish the safety determined image sensitive dose level and characterize the sensitivity specificity of CLR1502 in identifying malignant tissue.
Though we remain focused on the execution of our clinical programs, we are also seeking to increase awareness of our technology in development efforts and had a couple of meaningful opportunities to execute against this goal during the second quarter. In addition to the publication in science, translational medicine that Simon referenced, we’re pleased to have had not only a poster highlighting data from our Phase Ib dose escalation trial of I-131-CLR1404 in patients with advanced solid tumors presented at ASCO this year, but also a platform presentation by Dr. Perry Pickhardt characterizing the Company’s core diapeutic platform and its potential for combined oncologic imaging and treatment using I-124-CLR1404 and I-131-CLR1404.
ASCO is of course one of the most widely recognized and notable venues for sharing advances in cancer research, however there are several other meetings throughout the year that provide important opportunities to engage with spot leaders in the field and we look forward to having a presence at several such meetings throughout the coming year. The first of which will be the Radiologic Society of North America meeting, which meets in Chicago the week after Thanksgiving. A presentation will be given by Dr. Lance Hall on preliminary brain tumor imaging results.
So, Simon I will turn it back over to you.
So as you can see, we continue to work hard to implement meaningful clinical programs that have the potential to return significant value to the Company and in turn of course our shareholders.
Before I open up the call for questions, I would like to briefly touch upon another key achievement associated with our recent operating. And that is listing of our common stock on the NASDAQ capital markets. Move to NASDAQ is a significant milestone for Cellectar and underscores our commitment to grow the value of our Company and broaden our shareholder base. Over the past several months, we have focused our development efforts, prioritizing clinical programs that have clear path to regulatory approval and that serve to validate the breadth and capability of our cancer targeting platform.
With the data from our ongoing Phase II imaging trial of I-124 in glioblastoma, expected in the first half of 2015 and data from our proof-of-concept trial of I-131 for the treatment of multiple Myeloma and CLR-1502 for real time optical imaging in breast cancer surgery expected by the year-end in 2015, the coming year is poised to be a big one for the selector.
The strong fundamentals of the company together with the increased visibility that NASDAQ provides should have success in maximizing shareholder value over the short. 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’m not showing any questions on the phone lines at this time. I’d like to turn the call back to Dr. Pedder for closing remarks.
Well, thank you operator. I would like to thank everyone for joining us for today’s call and hope that you will continue to follow our progress. We look forward to speaking with you all again soon. Have a pleasant evening and good bye from all us.
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.
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