Cellectar Biosciences Inc (CLRB) 2014 Q2 法說會逐字稿

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. (Operator Instructions). 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 the US 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 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 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 and periodic report filed with the SEC, 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 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 feels 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 the registration process for the offering had a rather lengthy quite 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 manuscript in the works for well over a year, and reflects nearly a decade of work by Jamey and his colleagues, was not only accepted for publication but chosen as the cover story for the June 11 addition of Science Translational Medicine.

In this publication Jamey and his coworkers not only provide a comprehensive review of the unique broad-spectrum cancer targeting characteristics of our PLE platform technology, but showcase the inherent scope and flexibility of our technology that allows us to leverage its selective uptake and retention properties to create targeted diagnostic and therapeutic agents.

In doing so Jamey and his colleagues not only underscore 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 of a top-tier journal. But more importantly, we are excited about the opportunity to continue our development of this platform and associated agents.

Of course the clinical development and commercialization of our product candidates require 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 have now successfully completed an unwritten offering to generate gross proceeds to the Company of approximately $13.5 million.

In addition to bringing in some much needed capital that gives us over a year of operating runway, the offering also allows us to eliminate the debt that was issued in February by allowing those shareholders that generously provided us with bridge financing to exchange their convertible debentures for shares and warrants on the same terms offered to the buyers in this round.

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 necessitated substantial dilution to existing shareholders, we believe the additional capital combined with the execution in our clinical programs will better position us to deliver the returns warranted by the promise of our technology and we look forward to making the investment a valuable one for all.

Before we review development programs in greater detail I would 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 critical financing looming, it is 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, none of least of which being his contribution to this call as I will now ask them 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 potential 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 website.

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 have just completed an underwritten offering resulting in gross proceeds of approximately $13.5 million. After deducting expenses related to 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 the $4 million of debentures we issued in February. As Simon indicated, the offering will fund our current and planned development programs for over a 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 a 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 which was a 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 2014 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 burn to 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 will 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 would like to start with our most advanced program, our PET CT imaging agent 124-CLR1404, or as we frequently refer to it simply as I-124.

As you know, we initiated a Phase 3 imaging trial for I-124 in patients with glioblastoma earlier this year. This trial will compare the efficacy of our I-124 compound in accurately detecting glioblastoma with standard of care MRI based on pathology confirmation.

This trial continues to enroll patients and we are now ramping up the rate at which we are adding sites to the trial. We are still planning to have a total of approximately 10 centers participate in the trial. However, because of a pre-specified dose symmetry valuation following the first three patients, there was a bit of a delay in activating centers until that cohort and dose symmetry valuation had completed and full enrollment could proceed.

As there were no safety concerns reported by this cohort, the study began unrestricted enrollment during the second quarter and we are now looking to expedite the addition of remaining trial sites. However, because of this initial delay we now expect top-line results from this trial to be available in the 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 to the seven years of market exclusivity provided to orphan products upon approval, but also the advantages it provides in structuring smaller clinical trials requiring fewer patients to support a new drug application. And allowing for ongoing dialogue with assistance from the agency in designing clinical programs that adequately characterize the 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 1 proof of concept trial of our radio therapeutic, I-131-CLR1404 in this indication later this year. Because the radio sensitivity of multiple myeloma is well-documented and data supports cancer specific uptake and 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 [myelomanous] cells regardless of their anatomic distribution.

In preparation we recently submitted our investigational new drug, or IND application, to the FDA. Based on the 30-day review requirement for IND applications we anticipate hearing back from the agency by mid-September. Our current plan is to conduct a study in approximately 20 patients with relapsed refractory multiple myeloma who have previously been treated with or are intolerant of an immuno modulator 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 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 it hasn't yet generated that same headlines as our PET imaging or therapeutic programs, we continue to make progress in 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 initial preclinical 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 a dose ranging multi-site trial in approximately 20 patients undergoing lumpectomy in which we hope to establish the safety, determine image sensitive dose level and characterize the sensitivity and 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 and development efforts and had a couple meaningful opportunities to execute against this goal during the second quarter.

In addition to the publication in Science Translational Medicine that Simon referenced, we are pleased to have had not only a poster highlighting data from our Phase 1B 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 thought 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 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.

Thanks, Jamey. 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 to questions I would like to briefly touch upon another key achievement associated with our recent offering, and that is the listing of our common stock on the NASDAQ capital market.

The 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 paths to regulatory approval, and that serve to validate the breadth and capability of our cancer targeting platform.

With the data from our ongoing Phase 2 imaging trial of iodine 124 in glioblastoma expected in the first half of 2015 and data from our proof of concept trial of iodine 131 for the treatment of multiple myeloma and CLR1502 for real-time optical imaging in breast cancer surgery expected by the year end of 2015, the coming year is poised to be a big one for Cellectar.

The strong fundamentals of the Company, together with the increased visibility that NASDAQ provides, should assist us in maximizing shareholder value over the short (technical difficulty). 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 would 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 goodbye from all of us.

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.