Earnings Labs

Cellectar Biosciences, Inc. (CLRB)

Q1 2015 Earnings Call· Thu, May 21, 2015

$2.56

-0.02%

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Transcript

Operator

Operator

Good day ladies and gentlemen and welcome to the Cellectar First Quarter Conference 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 is being recorded. I would now like to introduce your host for today's conference Kathryn McNeil, Vice President, Investor Relations. Ma’am, you may begin.

Kate McNeil

Analyst

Thank you. Good afternoon and welcome to Cellectar Biosciences' first quarter 2015 conference call and webcast. We filled our financial statements for the first quarter of 2015 along with amended statements for the third quarter and full year 2014 with the SEC following the close of the U.S. financial markets yesterday. These followings can be found on our website at www.cellectar.com as well as on the SEC website www.sec.gov Joining me from Cellectar this afternoon is Dr. Simon Pedder, Chief Executive Officer; Dr. Jamey Weichert, Chief Scientific Officer, Chad Kolean, Chief Financial Officer; Dr. Kevin Kozak, Chief Medical Officer and Dr. Cameron Szakacs, Vice President of Clinical Development. Before I turn the call over to Dr. Pedder, let me note that some of the remarks you will hear 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 materially differ from those in these forward-looking statements is contained in our filings and periodic reports with the SEC, copies of which as I mentioned 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 made during today’s call. With that said, I will now turn the call over to Dr. Pedder. Simon?

Simon Pedder

Analyst

Thank you, Kate and thanks everyone not only for joining us on the call this afternoon but also for your patience as we postponed our original call to address some accounting matters related to previous reported financial results. While the primary focus of today’s call is to provide a quarterly update on our development programs and financial results for the first quarter, we will also take this opportunity to walk you through recent changes in our accounting that led to the restatement filed yesterday. Following our prepared remarks we will take some time to answer any outstanding questions. Chad why don’t you go ahead and get it started?

Chad Kolean

Analyst

Okay. Thanks, Simon. Before I get to the results for the quarter then I would like to take a few minutes to briefly discuss our restatement of our third quarter and full year 2014 financial results. As the restatement is on cash and [has] focus on the principal issues and the impact of the restatement and refer you to our amended filings to the complete details and the impact on those filed financial statements. As disclosed in an 8-K filed with the SEC on May 18, 2015, the Audit Committee in connection with an internal review conducted by our management team, determined that due to a misapplication of the accounting guidance related to certain previously issued warrants, restatement of our third quarter and full year financial statements was required. Let me give you a little background. On August 20, 2014 as part of our underwriting offering we issued approximately 3.8 million warrants to purchase shares of our common stock. We issued an additional 1.1 million warrants as part of our agreement with our debenture holders who also wants to participate in the offering, in exchange they extinguish the debentures that they held which represented approximately $4.2 million of principal amounted related to interest. So all of the warrants that I just mentioned have the same terms and conditions in exercised price, which is $4.68 per share. All of those warrants contain a cash settlement feature that would only apply in the event. There is no current perspective to support the issuance of registered stock and a warrant holder request gross settlement rather than the net settlement via cash flows exercise feature that is provided for in the warrant agreement. We believe that the confluence of these circumstances is highly unlikely. However, in such cases the technical accounting literature does not…

Simon Pedder

Analyst

Thanks Chad. Following our more comprehensive year end conference call in late March, today’s discussion will be comparatively briefly. However there are some key updates to each of our development programs I’d like to touch upon. Without question the most noticeable update since our last conference call is the initiation of a therapeutic trial, evaluating I-131 in patients with relapsed or refractory multiple myeloma. We currently have two of our three intended clinical sites operational and have been pleased by both the interest and the screening activity we are seeing at both. Based on the current activity and small cohort size we currently anticipate completion of the first cohort and the initiation of the second cohort this year. As we have previously indicated we believe the starting dose is sufficient to allow us to see evidence of clinical activity relatively early in the dose escalation process. Therefore expect to have meaningful data from this study well before the completion of this open label trail. Turning our attention to the I-124 program as we indicated in this afternoon's press release we are contemplating changes to our ongoing Phase II trial of glioblastoma, accrual into this trial continues to like behind the plan despite the actuation of additional clinical trial sites during the first quarter and an increase in screening following these site activations. As we continue to see value not only in I-124 as an imaging agent, but specifically as an imaging agent in glioblastoma we are seeking to leverage significant supplemental data stemming from multiple investigator sponsored imaging trails using this agent to image brain cancers including glioma. Thus we feel there exists the opportunity to utilize this data to determine the appropriate dosing and imaging parameters of I-124 in future studies. While a final determination has yet to be…

Operator

Operator

Thank you. Ladies and gentlemen. [Operator Instructions]

Kate McNeil

Analyst

Simon. We have received some questions via email and can begin here while we see if there are any additional questions from listeners dialed in to the call. The first question is as follows. Are there limits on the size of the payload carried by CLR1404? In other words so far as you are only attaching radioiodine which is very small, could you attach something like the M-1 or MMAE without impacting the tumor targeting properties of CLR1404?

Simon Pedder

Analyst

Well. That's a good question and one we have touched on in the past. I think I'll ask Jamey to review what we know of potential payload size and how early investigations of this question led to our current product candidates. Jamey?

Jamey Weichert

Analyst

Thanks, Simon. So this is really an excellent question. And we continue to build on our structure-activity database with our PLE carrier platform in order to assess the sub-cellular fate of these molecules we initially replaced the item with a small fluorophore that is compatible with confocal microscopy. We were a bit surprised that the fluorescent version of the molecule displayed similar broad scope tumor selectivity as the [ionaded] compounds. So we attached the much larger near-infrared fluorophore IR-775 which also displayed similar tumor targeting properties. This molecule CLR 1502 was the focus of our recent neurosurgery cover paper February 2015, and will enter clinical trial soon for real time surgical tumor margin illumination, as Simon stated previously in breast cancer lumpectomy patients. Our observations led both 1501 and 1502 display similar tumor targeting as 1404 demonstrates that the PLE delivery system tolerates considerable variations in [payload steric bulk]. We share the questioner's interest in additional compounds exploiting this observation and currently have an active research [active] along those lines. Frankly, this concept opens the possibility for broad application of the PLE targeting technology to potential vast array of both clinically proven and clinically abandoned cytotoxins like both suggested in the question. It’s also expected they stimulate numerous opportunities for collaboration between Cellectar and other companies. We’re excited about this opportunity. Kate?

Kate McNeil

Analyst

Great. Thank you, Jamey. Our second question is as follows. There is evidence that dexamethasone inhibits complement activation in the anti-tumor immune response to radiotherapy in mouse models. If no response is observed in a multiple myeloma study until dose escalation is complete and the study transitions to the no dexamethasone arm, what would that do to study timeline?

Simon Pedder

Analyst

Thanks Kate. I think there we can only estimate in the general sense the impact of timing. But clearly this is a question I’m going to ask Kevin to address with the role of A - no dexamethasone in the treatment of multiple myeloma in general and in our study in particular. Kevin?

Kevin Kozak

Analyst

Thanks, Simon. In short as a primary end point of the myeloma study of safety and tolerability, the presence or absence of responses with or without concurrent dexamethasone will have no direct impact on study timeline. But this is a really interesting question and probably deserves a little broader response. So I presume the questioner is referring to the very elegant work by [indiscernible] and colleagues published last month in Immunity. As is the case of all good science and devil is in the detail, it’s important to note that the vast majority of work reported by the [indiscernible] Group has performed in [miring] myeloma an entity knowing to be exclusively sensitive to immunotherapy both pre-clinically and clinically. This of course is reflected in the activity of nivolumab. The limited work beyond myeloma was restricted to a [miring] colorectal cancer cell line and here again there is an evidence that antibodies that [may] complement or active such as panitumumab and cetuximab. Of source it’s debatable whether or not complement activation is a significant contributor to the activity of these drugs given the [KRAS story] line but that’s pretty beyond the scope. Moreover in this study as is often the case that's preclinical model of radiotherapy, fraction size is employed where at least five grade and most commonly 20 grade, these doses are known to exert different biological responses and more typically employed clinical radiation doses. In the very limited human data presented the author simply demonstrated not frankly very surprisingly that radiation is co-inflammatory and a listed complement activation. Moreover these samples were in two cases in melanoma, three cases of basal cell carcinoma and one case of squamous cell carcinoma. For a moment it is getting a little deeper in to the [weeds] it's at least a little bit…

Kate McNeil

Analyst

Thank you, Kevin. Operator do we have any additional questions at this point?

Operator

Operator

I'm showing no questions at this time. I would like to turn the call back to Simon Pedder for closing remarks.

Simon Pedder

Analyst

First of all I would like to thank the person who sent in the questions via email. I'd like to thank everyone again for joining us for today's call. Hope you will continue to follow our progress and we look forward to speaking to you all again soon. Have a wonderful evening.

Operator

Operator

Ladies and gentlemen, thank you for participating in today’s conference. This thus concludes today's program. You may all disconnect. Everyone have a great day.