Cellectar Biosciences, Inc. (CLRB) Q3 2015 Earnings Call Transcript
Published at 2015-11-12 22:39:03
Jules Abraham - JQA Partners Jim Caruso - Chief Executive Officer Jamey Weichert - Chief Scientific Officer Chad Kolean - Chief Financial Officer Kevin Kozak - Chief Medical Officer Patrick Genn - Vice President of Business Development.
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 is being recorded. And now I will turn the conference over to your host Jules Abraham, from JQA Partners. Please begin.
Good afternoon and welcome to Cellectar Biosciences' third quarter 2015 conference call and webcast. Earlier today the company filed its financial statements for the third quarter 2015 with the SEC following the close of the U.S. financial markets. These filings can be found on the company’s website at www.cellectarbiosciences.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 Genn, 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. As well, there may be forward-looking statements during the Q&A session following the company’s 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 the 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 Biosciences does not undertake any obligation to update any forward-looking statements made during today’s call. With that said, I now turn the call over to Mr. Caruso. Jim?
Thank you, Jules and thank you to everyone joining us on this call. The last quarter represented the implementation of a corporate strategic shift for Cellectar Biosciences'. We repositioned the company around our phospholipid drug conjugate or PDC delivery platform and have focus resources on our therapeutic product portfolio including CLR 131 for relapse or refractory multiple myeloma and CLR CTX our research and development program designed to identify new chemotherapeutic product candidates. We are pleased with our progress and I look forward to providing today’s update. To briefly outline today’s call agenda, we will start by having our CFO, Chad Kolean provide a financial update. I will then deliver a general overview of our progress followed by a more detailed description of our CLR CTX chemotherapeutic program by Dr. Jamey Weichert, our Chief Scientific Officer. Then Dr. Kevin Kozak, our Chief Medical Officer will provide an update on our CLR 131 multiple myeloma study and recently initiated CLR 125 NCI funded study. Following those updates, 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.
Thank you, Jim. I’ll begin with our third quarter operating results. Research and development expenses for the quarter just ended were $1.2 million a reduction of $0.3 million from the third quarter in prior year. This reflects our continuing focus on making operating improvements that are resulting in reductions to cost structure. General and administrative expenses for the quarter totaled $0.8 million which is consistent with the same period in the prior year. We incurred $0.1 million of restructuring charges in the most recent quarter. They were no restructuring charges in the third quarter last year. We reported loss from operations of $2.1 million for the third quarter versus loss from operations $2.3 million for the comparable period in 2014. Other income for the third quarter in 2015 was $0.2 million as compared to $2.6 million in 2014. This change which is non-cash in nature is due to changes in the valuation of certain warrants that are classified as liabilities on our balance sheet. As a result, our net loss for the quarter just ended was $1.9 million or $0.25 per share, while in the prior year we reported net income of $0.3 million or $0.06 per share. We ended the quarter with 2.5 million in cash and cash equivalents compared to 9.4 million in cash and cash equivalents at December 31, 2014. This is exclusive of the funds we raised in the sales stocks and warrants that we closed on October, 1st, 2015, which generated 2.9 million of cash for us net of expenses. I’ll discuss that further in a moment. We estimate that our available cash and cash equivalents should fund the company’s planned operations into the second quarter of 2016. Additional capital will be required to complete our planned clinical and preclinical development. In terms of the financing that we completed on October 1st generated 3.3 million in gross proceeds or 2.9 million of net of expenses from the sale approximately 1,017,000 shares of stock and 483,000 pre-funded Series B warrants at $2.20 per share. Additionally, Series A warrants to purchase 1.5 million shares of our common stock, the strike price of $2.83 per share were included with each share of common stock or pre-funded warrant that was sold. This financing will enable us to advance our CLR 131 clinical trial in multiple myeloma continues to drive our CTX program and fund corporate activities. Certain terms of the financing requires stock holder approval. To address this requirement, special meeting of stockholders has been scheduled for November 30, 2015. A copy of the proxy materials will send to all stockholders of record as of October 23, 2015. It is very important that our stockholders approved this transaction so please go out and return your proxy card. Finally, as you may know, in August we received a notice from NASDAQ of non-compliance with its continued listing rules related to their requirement that we maintain a minimum of $2.5 million in total stockholder’s equity. This is a result of the reclassification of warrants as presented in our amended Form 10K/A as filed on May 20, 2015. We promptly responded to NASDAQ with our remediation plan which has been approved and is now being implemented. In the meantime, our stock will continue to be trade on NASDAQ exchange without interruption. Jim, I’ll turn it back over to you.
Thank you, Chad. On our 2Q conference call, we introduced a strategic shift for Cellectar that focuses our research and development resources to maximize what we believe to be our best near and the long term drivers. As you recall, the cornerstone of that approach was the selective development of therapeutic assets employing our proprietary PDC delivery platform. A primary corporate call of this shift was the addition of working capital to continue development of our lead product candidate, CLR 131 as well as fund our chemotherapeutic conjugate program. Later, we’ll support key pre-clinical studies to further characterize our in house chemotherapeutic conjugate formulation and facilitate potential R&D partnerships leveraging our PDC delivery platform. As discussed earlier this month, we closed on a $3.3 million financing to obtain company operating capital and to continue our focused research and development programs. Dr. Kozak will provide an update on our lead PDC therapeutic product candidate CLR 131 and our new PDC candidate CLR 125, a radioisotope that we believe maybe uniquely suited to treat micro-metastatic disease. We recently announced a National Cancer Institute Fast Track SBIR grant of up to 2.3 million of non-dilutive funding for the development of CLR 125 through a Phase 1 clinical trial. We have already launched this program and have successfully achieved milestones necessary to receive an initial grant payment. On our last call, we discussed the diversity of oncologic payloads that have been successfully conjugated without impacting our delivery vehicles cancer targeting, cellular uptake and expanded retention characteristics. These payloads have increased in size and complexity ranging from radioisotopes such as our current lead product candidate CLR 131 to CLR 1502 a large or key [ph] fluorophore. We are now investigating well characterized chemotherapeutics such as Paclitaxel and others as part of CLR CTX program. CLR 1603 is our lead PDC chemotherapeutic formulation which conjugates Paclitaxel as a payload with our cancer targeting delivery vehicle. We are conducting similar exploration with other chemotherapeutic payloads. As we further advance these PDCs through preclinical studies for each of them we will determine whether to conduct an in-house Phase 1, advance the compound we researched in development partnership or discontinue the research. Finally and importantly, I wish to remind our investors of the press release we provided earlier this week announcing that the company had converted our previously filed provisional patent application for Phospholipid Ether Analogs as cancer targeting drug vehicles to non-provisional U.S. and international patent applications. These patent applications further protect PDCs develop with Cellectar’s proprietary Phospholipid Ether delivery vehicle conjugated with any existing or future cytotoxic agents. This includes chemotherapeutics such as Paclitaxel for targeted delivery to cancer cells and cancer stem cells. Both composition of matter and methods of use are covered by these patent applications and provide intellectual property protection in the United States and up to 148 additional countries. This protection extends to at least November 2034 in the U.S. as well as key international markets providing a 20 year product development and commercialization runway. To further discuss, our chemotherapeutic conjugate program what we call CLR CTX I would like to briefly turn the call over to Dr. Jamey Weichert, our Chief Scientific Officer. Jamey?
Thank you, Jim. Since the introduction, there has been some discussion regarding our CLR CTX program. I would like to additional color to that discussion, review our progress to-date and further outline [indiscernible] potential. For the past few years, we have learned that our PDC our phospholipid drug conjugate platform is capable of caring a surprisingly broad range of payrolls to malignant cells without loss of cancer specificity. This suggest that conjugating anti-cancer agents with our phospholipid delivery platform may markedly improve the agents therapeutic index by enhancing drug concentrations at cancer sites and reducing normal tissue exposure because of drug toxicity. This may enhance the efficacy of available of anti-cancer agents and equally importantly [indiscernible] previously promising drugs that have been dropped from development due to toxicity. Thus far in our research we have seen preliminary results demonstrating that our Paclitaxel PDC molecules have displayed a cytotoxic effected 10 of 10 cancer cell lines tested. Specifically, we have completed proof of concept research on our PDC chemotherapeutic program including the development of multiple conjugated Paclitaxelanalogs. We have designed hydroligible[ph] and non-hydroligible [ph] linkers and optimize formulation without Cremophor, a toxic catalyzer, generally used to formulate Paclitaxel. These activities have resulted in the identification of a lead Paclitaxel conjugate CLR1603 that will be advanced to enviable safety evaluations of animal tumor models to demonstrate the targeting efficacy of our PDC delivery platform. The potential clinical advantages of our PDC platform over classical chemotherapy and possibly antibody drug conjugate approaches are its cancer selective targeting including brain metastases, superior cellular uptick and prolong tumor cell retention all of which have been validated by human imaging now in over 70 patients. In addition, PDCs have demonstrated the ability to target human [indiscernible] stem cells suggesting the potential to provide targeted drug delivery to cancer stem cells that are known adversely impact clinical outcomes in cancer patient quality of life. The potential to conjugate anti-cancer agents with our phospholipid ether delivery vehicle has tremendous clinical development significant. What this ultimately means the possibility of enhancing FDA approved on-market drugs and reviving or resurrecting broad range of anti-cancer drugs that have displayed less than ideal safety in efficacy profiles resulting from their inability to selectively target cancers. As our proof of concept research expands, we believe there will be increasing interest from potential partners that have invested considerable resources in agents that ultimately proved unworthy of clinical development due to inadequate therapeutic index or on market products that also would benefit from product profile improvements as well as considerable life cycle management benefits provided by our PDC platform. Jim?
Thank you for the summary, Jamey. We remain excited about the potential of our CTX program and look forward to sharing future CTX accomplishments. During the last call, we outlined an aggressive plan to leverage our PDC delivery platform into value generating outcomes and have renewed high energy and performance focus from management. I believe we have effectively executed versus that plan and we remain enthusiastic about our strategic course corrections. We will continue our crystallized focus on advancing our PDC platform technology including bringing CLR 131 through Phase 1 in multiple myeloma. Further characterizing, CLR1603 as well as developing other in-house conjugated key chemotherapeutics while exploring potential CTX research and development collaboration opportunities. I would now like to turn the call over to Dr. Kevin Kozak, our Chief Medical Officer to discuss our on-going Phase 1 clinical trial in relapse or refractory multiple myeloma and provide a brief update on NIC grant sponsored CLR 125 research.
Thanks, Jim. I would like to take this time to discuss our current Phase 1 program examining CLR 131 in multiple myeloma. As most of the listeners are aware, myeloma is a common, yet incurable malignancy of plasma cells that’s diagnosed in about 30,000 Americans each year and clearly qualifies as an orphan disease. This is a disease characterized by both defuse distribution and radio sensitivity suggesting a systemic radio pharmaceutics may have a roll in the therapeutic armamentarium. Well, available treatment option that generally shows substantial activity in newly diagnosed disease invariably myeloma recurs and option dwindle in the relapse and refractory settings. CLR131 is composed of iodine-131, a cytotoxic radioisotopethat selectively delivered myeloma cells via our targeted PDC platform. Today, preclinical evidence documents both myeloma targeting and activity consequently based both on preclinical evidence and disease characteristics we are excited about multiple myeloma as our lead indication for CLR 131. Furthermore, we believe that based on the significant unmet medical need and our previously obtained orphan drug designation we may have unique regulatory opportunities through FDEs expedited programs for serious conditions such as fast track, breakthrough designations and accelerated approval. In our multi-centre open label Phase 1 dose escalation study for relapse or refractory multiple myeloma currently underway, our primary objective is to characterize the safety intolerability of CLR131 in this patient population. Secondary objectives include establishing the recommended Phase 2 dose both with and without dexamethasone and of course, assessing the therapeutic activity of CLR 131. While the study is currently underway and we do not have a clinical update at this time, our initial objective is to observe clinical tolerability at our starting dose that permits dose escalation. Given our genuine optimism regarding CLR 131 in multiple myeloma, we’ll of course, also be looking for quantitative evidence of drug activity even in the first cohort of patients. We expect to share information regarding the first cohort as well as initiate the second cohort in the first half of 2016. Now moving on to our recently announced program funded by the highly competitive NCI Fast Track SBIR grant program examining CLR 125 conjugate of our PDC platform in the therapeutic radioisotope I-125 for the potential treatment of micro-metastatic disease. We want to emphasize that this is non-dilutive funding to support as they granted self reads the research and development of new or improved technologies and methodologies that have the potential to succeed as commercial products. The research focus of this grant is for the new agement [ph] treatment of Triple negative breast cancer, a preclinical model ideal for the purposes of assessing CLR 125 is potential to address micro-metastatic disease. However, the grant provides the opportunity to carefully assess the promise of CLR 125 and clinical indications will of course follow the data. I-125 is a unique radioisotope with well described radio biologic advantages for the treatment of small volume diseases. In array of malignancies as characterized by dominant liaisons accompanied by defuse micro-metastatic disease and in nearly all of those settings it the later that presents the clinical challenge. We believe that CLR 125 has a capacity to address this challenge and we proved to have a broad therapeutic index due to a very low risk of myelosuppression. Based on the findings of the proposed preclinical work, the National Cancer Institute may grant up to $2.3 million to fund the first in human study. This is substantial validation of the significant potential of our PDC delivery system. With that, I’m pleased to turn the call back over to Jim.
Thank you, Kevin. As I hope as evident, we are rapidly advancing Cellectar’s cancer targeting platform. We expect to increase shareholder value by maintaining focus on the PDC platform and its multiple therapy therapeutic opportunities, both our in-house, radio therapeutic and chemotherapeutic development as well as potential partnerships to support our expanding drug conjugate program. While these corporate initiatives have only recently started, we are making meaningful progress and remain focused and committed to unlocking the value of our PDC delivery platform. Thank you very much for your participation on this call and your continued interest in Cellectar. At this time, Chad, Jamey, Kevin, Patrick and I welcome any questions that you may have.
While we wait for questions from the queue we’d like to address several questions we received over email over the last few days. First, I have a question related to the objective of the PDC chemotherapeutic program. What are the objectives with your paclitaxel PDC CLR scene 03 preclinical studies? Are you looking to create a new paclitaxel drug candidate for further human clinical studies or is this separates more of a proof of concept exercise?
Okay. Thank you, Jules. And that’s a good question. It’s the right question. [Indiscernible] Mr. Jamey to get your thoughts.
Thanks, Jim. So the first objective to demonstrate proof of concept before PDC’s platform availability to both conjugate paclitaxel with our cancer targeting vehicle thus creating new phospholipid drug conjugate or PDCs and also subsequently to demonstrate the PDC’s ability to provide targeted delivery paclitaxel payload selectively the cancer cells. We chose paclitaxel as a chemotherapeutic payload because it is well characterized. Its tolerability and efficacy are well understood and further it is a larger chemotherapeutic payload and therefore provides a very good proxy for the potential of our PDC platform to provide targeted delivery of a broad range of chemotherapeutic payloads. Our preclinical studies demonstrate that CLR 1603 has the potential to provide to improve the therapeutic window of standalone paclitaxel than a secondary at very important objective would be the potential to advance CLR 1603 into human clinical studies as a promising new targeted chemotherapeutic either on our own or with a co-development partner. Jules?
Thanks, Jamey. I have one more question here from email. With respect to your Phase 1 multiple myeloma trial with CLR 131 you stated that you expect to share data from your first cohort during the first half of 2016. Can you provide color around what type of data would be considered positive for this first group of patients?
Jim, maybe I’ll grab this one if okay?
Sounds good. Thank you, Kevin.
All right. So obviously in a Phase 1 dose escalation trial drug tolerability and a cohort is considered a success. So dose escalation would be the key success. But in light of our preclinical data in myeloma and it’s known radio sensitivity we will of course also be looking for early signal for activity something that’s quite straight forward in myeloma with easily access quantitative markers of disease burden such as serum M-protein.
Okay. Terrific. Thank you, Kevin.
Thank you. We do have a question online. Our question is from Patrick [indiscernible] of Cellectar.
Yes, what’s the status of the imaging products?
Hi, is this – who is this, Patrick?
Hi, Patrick. This is Jim. Thank you for your question. I mean what we’ve done as we have reviewed our corporate portfolio, we really assessed those products that we believe in the short-term could provide significantly for our shareholders and we’ve made the decision that our therapeutic product portfolio based on the promise of 131 for multiple myeloma and potentially other hematologic malignancies as well as the immense upside potential for our CLR CTX program which allows us to capacity to conjugate any cytotoxic potentially creating new drugs with new intellectual property. And that 20 years runway that I had referred to as I read through the script it was clear for us in order to optimize our current dollars and create optimal shareholder value that investing in and around the therapeutic program was and there is the appropriate play. Now having said that we obviously remain very confident and the quality of about CLR 124 as well as CLR 1502 both are very interesting assets as you know, one for diagnostic imaging and other for optical imaging. We remain confident at some future point we will have the capacity to partner those assets with companies that would be willing to take on the line share of the research and development cost associated with advancing those products through the clinic. So although we have a high degree of confidence in the future of those assets it’s very clear to us in order to optimize shareholder value that the right play for us to invest around the immense upside potential that our therapeutic product portfolio presents.
My pleasure. Thanks for the question.
[Operator Instructions] And there are no further questions at this time. We’d like to turn the call over for management for any closing remarks.
Okay. Thank you, Theyron. I would once again like to thank everyone for joining us for today's call. I hope you found that the information and discussion to be a value and we will continue to follow our progress as we advance the company. We certainly as an executive leadership team look forward to speaking with you again soon. Thanks again.
Ladies and gentlemen, thank you for participating in today's conference. This concludes the program and you may now disconnect. Have a wonderful day