Earnings Labs

Cellectar Biosciences, Inc. (CLRB)

Q2 2015 Earnings Call· Wed, Aug 12, 2015

$2.56

-0.02%

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Transcript

Operator

Operator

Good day, ladies and gentlemen. And welcome to the Cellectar Second 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 is being recorded. I would like to introduce your host for today's conference Mr. Jules Abraham, JQA Partners. Sir, you may begin.

Jules Abraham

Analyst

Thank you. Good afternoon and welcome to Cellectar Biosciences' second quarter 2015 conference call and webcast. Earlier today Cellectar filed its financial statements for the second quarter 2015 with the SEC following the close of the U.S. financial markets. These followings can be found on Cellectar's website at www.cellectar.com in the Investor Relations section as well as on the SEC website at www.sec.gov. Joining me today from Cellectar is Jim Caruso, Chief Executive Officer; Dr. Jamey Weichert, Chief Scientific Officer, Chad Kolean, Chief Financial Officer; Dr. Kevin Kozak, Chief Medical Officer and J Patrick, Vice President of Business Development. Before I turn the call over to Mr. Caruso, please note that some of the remarks you will hear may contain forward-looking statements about the company’s performance. There may also be forward-looking statements during the Q&A session following the 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 those 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 Company's filings and periodic reports filed with the SEC, copies of which are available on its website or maybe requested directly from the company. Forward-looking statements are made as of today’s date and Cellectar does not undertake any obligation to update any forward-looking statements made during today’s call. In addition, I also want to ensure that you access the PowerPoint presentation that will be featured during part of Mr. Caruso's comments today. If you have not previously done so, the presentation to be found online using the link found in our August 7 press release. With that said, I would like to turn the call over to Mr. Caruso. Jim?

Jim Caruso

Analyst

Thank you, Jules. And thank you to everyone joining us on the call this afternoon. Before we begin with our quarterly business update, I'd like to take this opportunity to express my appreciation for becoming a part of the Cellectar Biosciences' team and this exciting company. The drivers of my decision to join Cellectar included the great people associated with the company, the managing community and the company's tremendous asset, its unique cancer targeting delivery platform. This delivery platform provides the potential to generate multiple advances in the treatment and management of cancer. It is time that we make this potential a reality. To briefly outline today's agenda, we will start by having our CFO, Chad Kolean, provide a financial update. I'll then share my corporate vision as well as our plan to advance Cellectar's promising cancer targeting delivery platform. Following my update and presentation that you can locate online, the executive leadership team will be available to answer your questions. At this time, I'd like to turn the call over to our CFO, Chad Kolean for our financial update.

Chad Kolean

Analyst

Thank you, Jim. For our second quarter which ended on June 30, 2015, we reported a net loss of $2.3 million or $0.30 per share versus a net loss of $2.1 million or $0.73 per share for the comparable period in 2014. Research and development expenses for the quarter were $1.4 million which was consistent with the same period in the prior year. Our general and administrative expenses for the second quarter of 2015 totaled $0.8 million, reflecting a decrease of about $100,000 from the comparable period in the prior year. We ended the quarter with $4.8 million in cash and cash equivalents compared to $9.4 million in cash and cash equivalents at December 31, 2014. We estimate that available cash and cash equivalents should fund the company's planned operations into the fourth quarter of 2015. Additional capital will be required for us to complete our planned clinical and preclinical development. And with that I'll turn it back over to Jim.

Jim Caruso

Analyst

Thank you, Chad. I'd like to take this opportunity to broadly discuss the corporate blueprint that Cellectar will follow to successfully move our company forward. In close collaboration with the management team, I've been evaluating our company's assets and the product development and commercialization program. The objective of this evaluation has been to prioritize organizational opportunities that we believe will provide our shareholders with a greatest return on investment. Additionally, the management teams have completed an evaluation of projected spending and have initially reduced cost by approximately $2 million over the next 18 months. We will continue to evaluate our cost structure to identify other opportunities to enhance operational efficiencies and extend our runway. Cellectar's cancer targeting and delivery platform clearly possesses considerable potential to create meaningful products for the treatment, diagnosis and monitoring of a broad range of cancers. The extensive number of therapeutic and other applications in our current portfolio presents a practical resource allocation and execution challenge. Based on the analysis previously discussed, it is clear that the company must focus its resources on advancing our therapeutic product candidates. We believe our therapeutic product candidates provide significant upside and merit our organizational focus and resources. We are confident this is the most effective approach to create and sustain shareholder value. In parallel, we will seek value optimizing approaches for our impressive diagnostic imaging portfolio. Central to the execution of our therapeutic portfolio focus plan to Cellectar's proprietary phospholipid technology platform. As you likely know, this platform is the basis for all of our product candidates and provides highly targeted delivery of diverse oncologic payload to a broad range of cancers. We are calling this best in class technology a phospholipid drug conjugate or PDC platform which we are introducing today as the cornerstone of our development strategy.…

Jules Abraham

Analyst

While we wait for questions to gather in queue, we have over the last several days received several questions via email that we would like to take this time to address. The first being, Jim, a request to please provide an update on multiple myeloma study.

Jim Caruso

Analyst

Okay, Jules. Thank you and thank you for the question. Why don’t I provide some general background and I'll ask Dr. Kozak to further provide his thinking as well. Organizationally, we obviously like 131 in relapse/ refractory multiple myeloma make sense on a lot of levels for us. As you are aware we initiated this Phase I study this past April I believe in and around the middle of the month. As you may recall, the objective of the Phase I study is to identify CLR 131’s maximum tolerate dose. Our initial cohort with the first cohort initial dose is 12.5 mCi per meter squared and we will escalate by 6.25mCi per meter squared for each subsequent cohort. Now each cohort is scheduled to enroll three patients. Once we identify the maximum tolerated dose, we will then add an additional three patients at that maximum tolerated dose. As I reviewed in my earlier comments, we expect to complete the enrollment of cohort one as well as provide an update and initiate the second cohort in the first half of 2016. And having said that Kevin do you have an additional color or commentary that you would like to add.

Kevin Kozak

Analyst

Sure. Thanks, Jim. While we are still early in the study I think there remain several reasons for optimism regarding the completion of enrollment of the first cohort within the timeline you outlined. First the three centers involved the University of Wisconsin, Mayo Clinic and Loyola, all at robust myeloma clinical trial program and each is represented by enthusiastic and experienced clinical trialist. Secondly, the investigators are uniquely enthusiastic about the study of CLR 131 in relapsed/refractory myeloma because of its novel mechanism of action, its potential to selectively deliver radio therapy to a disease well documented to be highly radio sensitive. And finally because these third line patients have a real unmet need for treatment alternative. These of course are also fundamental reasons why we selected the relapsed/refractory myeloma population as our first indication to advance CLR 131 through the clinic.

Jim Caruso

Analyst

Terrific, Kevin. Thank you. Jules?

Jules Abraham

Analyst

One more question which was that recently announced that the FDA will review 1502 as a combination and drug candidate and the question is what impact will this have on Cellectar's development plans?

Jim Caruso

Analyst

Okay. So question, I touch on this briefly in my notes as part of the script. And as obviously the person answering the question already knows and many of you online that the company had in fact received feedback from the FDA that 1502 is categorized as a combination product and as a result would require an IDE application. And as you are probably aware we originally submitted an IND. So taking a step back, what does this mean for Cellectar and a potential developmental partner, right? So from a regulatory process perspective and as a result we will be working now more closely with CDRH which is the Center for Devices and Radiologic Health as opposed to CDER which is the Center for Drug Evaluation and Research. And as a result, 1502 the regulatory pathway that we will -- we require to advance this product through would be as an IDE versus an IND. Based on our assessment as I referenced, we believe that the IDE regulatory pathway quite frankly is going to be less arduous than an IND. There are a number of reasons for that. Of course since we are required to submit an IDE application, this resubmission will likely delay the regulatory process, it will delay the regulatory process. However, we've used this time to fine-tune the proposed Phase I study. And as a result are confident that the new study will have among other advantages capacity to enroll patients faster and as a result to be completed sooner. Ultimately we believe the time loss to the resubmission in the IDE application process will be more than compensated by a more rapid or quicker Phase 15, and I think ultimately at the end of the day the most important element here is regardless of the regulatory pathway the product is treated the same way once approved for marketing. So the net is we strongly believe in the clinical value of 1502. We look forward to a potential clinical development and/or commercialization partnership in order to more rapidly advance this asset and make it available for the surgeons and patients that may benefit from its use.

Jim Caruso

Analyst

Operator, do you have any other additional questions at this time.

Q -

Analyst

Operator

Operator

No, sir. No other questions in queue at this time.

Jim Caruso

Analyst

Okay. Well, if that being the case, I would once again like to thank everyone for joining us for today's call. I hope that you found the information and the discussion to be value. And we will continue to follow Cellectar's progress. We look forward to speaking with you again soon. Thanks again for your time.

Operator

Operator

Ladies and gentlemen, thank you for your participation in today's conference. This concludes the program. You may now disconnect. Everyone have a great day.