Cellectar Biosciences, Inc.

Cellectar Biosciences, Inc.

$1.58
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NASDAQ Capital Market
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Biotechnology

Cellectar Biosciences, Inc. (CLRB) Q1 2016 Earnings Call Transcript

Published at 2016-05-13 00:40:59
Executives
Jules Abraham - Investor Relations, JQA Partners Jim Caruso - Chief Executive Officer Jamey Weichert - Chief Scientific Officer Chad Kolean - Chief Financial Officer Kevin Kozak - Chief Medical Officer
Analysts
Jeff Hart - Hart Partners
Operator
Good day, ladies and gentlemen and welcome to the Cellectar First Quarter 2016 Earnings Conference Call. At this time, all participants are in a listen-only mode. [Operator Instructions] I would now like to introduce your host for today’s conference, Mr. Jules Abraham from JQA Partners. Mr. Abraham, you may begin.
Jules Abraham
Thank you, Andrea. Good afternoon and welcome to the Cellectar Biosciences’ 2016 first quarter conference call and webcast. Earlier today, the company filed its financial statements for the quarter ending March 31, 2016 with the SEC following the close of U.S. financial markets. These filings can be found on its 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 today are Jim Caruso, Chief Executive Officer; Dr. Jamey Weichert, Chief Scientific Officer; Chad Kolean, Chief Financial Officer; and Dr. Kevin Kozak, Chief Medical Officer. Before I turn the call over to Mr. Caruso, please note that some of the remarks you will hear today may contain forward-looking statements about the company’s performance. As well, there may be forward-looking statements during the Q&A session following our prepared remarks. These statements are neither promises nor guarantees and there are 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 filed with the SEC. Copies of which are available on the company’s website or maybe requested directly from them. Forward-looking statements are made as of today’s date and we cannot 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 Mr. James Caruso. Jim?
Jim Caruso
Thank you, Jules and thank you to everyone joining us today for our first quarter 2016 call. The last two quarters of 2015 and the first quarter of 2016 continue to represent a significant shift in corporate objectives, culture and branding for Cellectar Biosciences. Significant progress has been achieved and we remain confident in our corporate strategy, operating plan execution and our delivery platform technology. We are pleased with the resulting program advancements and look forward to providing further color on today’s call. To briefly outline the call’s agenda, we will start by having our CFO, Chad Kolean provide a financial summary and a recap of our recently completed public financing. I will then deliver a general overview of our progress. Dr. Kevin Kozak, our Chief Medical Officer, will provide a detailed update regarding CLR 131, our exciting PDC currently in a Phase 1 study for the treatment of multiple myeloma. Following this update, Dr. Jamey Weichert, our Chief Scientific Officer, will review the research advances with our CLR/CTX chemotherapeutic conjugate program and then update on expected preclinical milestones as well as other ongoing R&D initiatives. Of course, at the conclusion of the call, the executive leadership team will be available to answer your questions. At this time, I would like to turn the call over to our CFO, Chad Kolean for our financial update.
Chad Kolean
Thank you, Jim. Over the next few minutes, I will address the following: the recently completed underwritten offering that we closed on April 28, the restructuring of the warrants we issued as part of our October 2015 financing, our NASDAQ compliance status and our financial results for the first quarter of 2016. On April 28, 2016, we closed a firm commitment underwritten public offering registered on Form S-1 originally filed in December 2015. The initial book resulted in $7 million of gross proceeds. Prior to the closing, the underwriter exercised its over-allotment in full, which represent another $1 million of proceeds for a total of $8 million. After deducting commissions and other expenses related to the offering, Cellectar realized net proceeds of approximately $7.2 million. In terms of securities, we sold 1,871,321 shares of common tock and 1,908,021 pre-funded warrants in addition to 3,779,342 Series A warrants, which includes shares and warrants covered by the over-allotment option. We offered either common stock with Series A warrants at a 1:1 ratio for $2.13 or pre-funded warrants with Series A warrants at a 1:1 ratio for $2.12. The pre-funded warrants were offered to those investors who did not wish their beneficial ownership of our outstanding common stock to exceed 4.99%. The pre-funded warrants are immediately exercisable at $0.01 per share. Since the closing of the offering through May 10, we have issued approximately 1.1 million shares of common stock pursuant to exercises of the pre-funded warrants issued in this transaction. The Series A warrants have an exercise price of $3.04 per share are also immediately exercisable, expire in 5 years and are callable by the company under certain circumstances. These warrants are also listed on the NASDAQ Capital Markets under the ticker symbol, CLRBZ. None of the warrants issued as part of this offering have any pricing or quantity reset provisions. In April, we effected a restructuring of the warrants that we issued in October 2015 in connection with a registered direct offering of common stock. In that offering, we issued 48,274 Series B pre-funded warrants to purchase 48,274 shares of common stock for an aggregate purchase price of approximately $1,062,000. In a concurrent private placement, we issued 150,003 Series A warrants with an initial exercise price of $28.30 exercisable beginning on April 1, 2016 for a period of 5 years, into these series of warrants as issued had a price protection feature. The exercise price of the Series A warrants reset to the price of subsequently issued common stock if that price was lower than the effective exercise price, until such time that we closed a financing yielding proceeds of at least $10 million. For the Series B pre-funded warrants, the number of common shares for which the warrant maybe exercised increases in the event of an issuance of shares of common stock at less than the initial purchase price of the warrant as adjusted. Prior to entering the underwriting agreement for the April 2016 public offering, we signed agreements with the holders of the warrants issued in October 2015, which provided for the amendment of the Series A warrants to remove the exercised price reset. Following the closing of the April 2016 public offering and to reduce the exercised price of those warrants to the per share public offering price of the common stock of $2.13 and the issuance on essentially the same terms as the amended Series A warrants of warrants exercisable for twice the number of shares for which Series A warrants were initially exercisable also with a $2.13 per share exercise price. We expect that without the price reset provisions, the amended Series A warrants and the newly issued warrants, will no longer be accounted for as derivatives. These restructuring agreements also provide for the exchange of Series B pre-funded warrants issued in October 2015 per shares of a new series of convertible preferred stock having limited voting rights and having no dividend or liquidation preferences over the common stock. The new series of preferred stock will have essentially the same terms and conditions as the Series B pre-funded warrants, including the continuation of the price protection feature. We expect that exchanging the Series B pre-funded warrants per shares of the new series of preferred stock will result in equity treatment. The restructuring agreements with the investors regarding these warrants are subject to our obtaining stockholder approval and will be included as agenda items in our upcoming shareholders meeting. Until we receive the approval of the stockholders, we cannot issue any new common stock for the purposes of raising funds except in very limited circumstances, unless we receive the approval of certain holders of the October 2015 Series A warrants. Regarding our NASDAQ listing compliance, on March 31, 2016, NASDAQ conducted a hearing at which we requested an extension from NASDAQ until May 16, 2016 to complete the then pending public offering and demonstrate compliance with the minimum equity requirement. NASDAQ granted this request. As part of the filing of our Form 10-Q earlier today, we believe we have met this requirement and are awaiting confirmation from NASDAQ. There can be no assurance however that NASDAQ will close the listing qualifications matter as a result. Now, I will discuss our operating results for the first quarter of 2016. Research and development expenses for the current quarter were $1.0 million, a reduction of $0.6 million from the first quarter last year. As we noted in our release, this improvement is a result of our strategic focus on our therapeutic compound research and development efforts and a streamline clinical trial approach we implemented in the second half of last year. General and administrative expenses for the year totaled $1.0 million, which is consistent with the first quarter of 2015. Our loss from operations was $2.0 million for this quarter versus a loss from operations of $2.6 million for the same quarter last year. Other income was $2.8 million for the first quarter of 2016 as compared to $0.3 million in the first quarter last year. I want to make it clear that other income is almost exclusively non-cash in nature and is due to changes in the valuation of certain warrants that are classified as liabilities on our balance sheet. As a result, we generated basic net income for the quarter ended March 31, 2016 of $0.8 million or $0.96 per share which is $0.91 per share fully diluted. While in the quarter ended March 31, 2015, we reported a net loss of $2.3 million or $3.04 per share. As I mentioned previously based on the warrant restructuring, we expect that the non-cash other income loss activity reflecting the treatment of certain warrants as derivatives will be substantially reduced on a go forward basis. As of March 31, 2016, we had $1.9 million in cash and cash equivalents on hand compared to $3.9 million in cash and cash equivalents at December 31, 2015, when added to the approximately $7.2 million we generated from the recently completed offering, we estimate that our available cash and cash equivalents should fund the company’s planned operations into the first quarter of 2017. Additional capital will be required to complete our planned clinical and preclinical development. And with that, I will turn the call back over to Jim.
Jim Caruso
Thank you, Chad. We are pleased with our recent financing and the capacity upsides, the deal from the original $6 million target to $8 million. The operating runway established by this financing allows the company to execute its research and clinical development programs and achieve what we believe to be value transforming milestones. Additionally, we believe this successful financing and the company’s associated capital structure enhancements will allow Cellectar to maintain its NASDAQ Exchange listing. Prior to reviewing our near-term Q2 and Q3 planned milestones, let’s first review the achievements of the past quarter. In January, we announced positive cohort one clinical data from our Phase 1 study of CLR 131 for the treatment of relapse or refractory multiple myeloma. Immediately following this announcement, we initiated the second cohort of this study and opened patient enrollment. The Phase 2 dose of CLR 131 to this cohort is 18.75 millicurie per meter squared which is a dose increase of 50%. Additionally we made further advancements with the development of our CLR CTX chemotherapeutic conjugate program. This in-house PDC program is designed to convert non-targeted chemotherapeutics to targeted agents providing the preference for dose delivery to cancer cells versus healthy cells altering the drug’s existing therapeutic index to potentially enhance efficacy and reduce adverse events. In addition, we launched a chemotherapeutic conjugate R&D program collaboration with Pierre Fabre, which we announced in the December 2015 timeframe. We believe our delivery platform technology and PDC assets provide the company with the potential for future collaborations. And finally, in addition to the successful completion of recent public filings, we remain diligent to P&L management to optimize our operating runway. It is important to note that the company will remain opportunistic relative to strategic hires and projects that will accelerate and enhance corporate value drivers such as the advancement of our collaboration platform. In summary, the company is now positioned to execute a therapeutic focused research and clinical development plan to further market its delivery platform and achieve near-term value transforming milestones in 2016. Let’s now transition to a more detailed discussion of our research and clinical development program updates and begin with Dr. Kevin Kozak, our Chief Medical Officer to further discuss our Phase 1 study of CLR 131. Kevin?
Kevin Kozak
Thanks Jim. At this time I would like to further discuss our current Phase 1 program evaluating CLR 131 for the treatment of relapse, refractory multiple myeloma. It’s important to note that myeloma’s incurable malignancy of plasma cell is diagnosed in approximately 30,000 Americans each year, qualifying it as an orphan disease. This hematologic cancer is characterized by both defuse distribution and radio sensitivities suggesting a systemic radio therapeutic may have a role in the armamentarium for multiple myeloma. While available treatment options generally display substantial activity in newly diagnosed disease, invariably myeloma recurs in both treatment response rates as well as time to disease progression dropped significantly in the relapse and refractory setting. As a result and despite recent expansion in treatment option there remains a high unmet clinical need. Our lead compound CLR 131 is composed of iodine 131 a cytotoxic radioisotope that is selectively delivered to myeloma cells via our targeted PDC platform. In our multi-center open label Phase 1 dose escalating study for relapse or refractory multiple myeloma currently underway, our primary objective is to characterize the safety and tolerability of CLR 131 in this populations. Secondary objectives include establishment of the recommended Phase 2 dose both with and without dexamethasone as well as an assessment of therapeutic activity. December 2015, we announced the completion of the first cohort and in January 2016 we shared positive clinical data demonstrating CLR 131 safety and tolerability with a favorable adverse event profile. Additionally, stable disease was achieved in four of the five patients dosed including two patients who maintained progression pre-survival throughout the 85-day study monitoring period. As a result our data monitoring committee unanimously recommended dose escalation from 12.5 to 18.75 millicurie per meter squared. The five patients enrolled in the first cohort were heavily pre-treated with each having received the minimum of three to as many as 12 lines of prior systemic treatment. Therapeutic performance in the multiple myeloma relapse refractory setting is clearly a challenge and often involves multi-agent regimen. To provide response performance contact, patients with two prior lines of treatment on average achieved a response rate of about 25%. And the one in four responders on average achieved progression pre-survival of approximately six months. I would like to note that two of the four patients achieving stable disease in the first cohort remain progression free throughout the 85-day study follow-up period. At progression, planned treatment for one of these patients is an autologous stem cell transplant and the second patient was placed on a newly approved myeloma therapy. Although obviously the numbers are small and we remain diligent following the patients off-study, this strongly suggest that CLR 131 treatment does not limit therapeutic options moving forward. Our second cohort has initiated patient enrollment and we continue to plan to provide an update on cohort two results and initiate cohort three in the third quarter of this year. Primary objective of cohorts used to observe the clinical safety and tolerability of CLR 131 at the higher 18.75 millicurie per meter squared dose and determine whether further escalation is appropriate. Given our genuine optimism regarding CLR 131 in multiple myeloma, we look forward to assessing drug performance in this and future patient cohorts. With that I am pleased to turn the call back over to Jim.
Jim Caruso
Thank you, Kevin. We remain excited about the potential of CLR 131 for the treatment of multiple myeloma. This may be an extremely meaningful program for Cellectar and the many patients that may benefit from its therapy. I would now like to introduce Dr. Jamey Weichert, our Chief Scientific Officer. Jamey will provide an update on our CLR/CTX chemotherapeutic PDC research program, a recap of our CTX collaboration with Pierre Fabre, and a review of our progress to-date with our NCI-funded research of our CLR 125 PDC. Jamey?
Jamey Weichert
Thank you, Jim. Since our last update, we have continued to rapidly advance our CTX program development. We believe with the improved cancer targeting provided by our delivery platform that we can combine our PDC delivery vehicle with chemotherapeutic agents to convert untargeted drugs into new targeted agents. We expect the new targeted agent or PDC to possess an improved therapeutic index potentially impacting the original drug’s efficacy and tolerability profile in a positive manner. This will also result in the creation of new products, established new patent life and provide a meaningful lifecycle management resource. To-date, we have initiated work with a number of on-market generic chemotherapeutics. We are focused on our paclitaxel series of PDCs to fulfill our near-term goal of further validating in vivo cancer tumor targeting with chemotherapeutic payloads via our PDC delivery platform. Furthermore, we remained focused on developing the research capacity to assess in vivo targeting for greater numbers of chemotherapeutic PDCs more efficiently and rapidly. As you may recall, our delivery vehicle has demonstrated a cancer targeted preference of approximately sixfold to tenfold dependent on cancer type. We believe even a far more modest shift in preferential cancer targeting may have a meaningful impact on the adverse event profile of some chemotherapeutics. To-date with our paclitaxel series of distinct PDCs, we have completed larger scale synthesis, formulation without Cremophor in vitro cytotoxicity assays and plasma and liver enzyme stability assays. I cite the Cremophor formulation removal as it is a component of the currently utilized paclitaxel formulation that is known to create a significant increase in adverse events. From these results, we have selected CLR 1602 as the lead for subsequent tumor targeting in vivo studies. To accomplish these near-term goals and for future studies, we have completed the synthesis of deuterated CLR 1602 as well as a deuterated form of our delivery vehicle. The deuterated form of our delivery vehicle will allow us to more efficiently assess specific PDC tumor targeting. In collaboration with our selected CRO partners, we expect to have initial targeting data involving tumor-bearing animals prior to the conclusion of Q2 2016. This quantitative in vivo bio-distribution assessment is an important step in providing further proof-of-concept for chemotherapeutic PDC targeted delivery as well as a research opportunity to further refine conjugate and linker modifications. As you are likely aware, we announced the collaboration with Pierre Fabre in December of 2015 and launched the program in the first quarter of 2016. We review the Pierre Fabre deal as an important first step in building out our collaboration model and advancing our R&D through strategic partnerships. We remain extremely excited about the synergistic relationship as do our partners at Pierre Fabre. The objective of this collaboration is to combine Cellectar’s PDC platform with a selection of Pierre Fabre’s proprietary chemotherapeutics. Some of these non-targeted agents have demonstrated early promise. However, Cellectar and Pierre Fabre believe transforming these agents to targeted drugs will enhance their respective product profiles. These new PDCs will be designed to exhibit high selectivity to our cancer cells in order to expand therapeutic index and to provide improved clinical performance for otherwise highly potent, but non-targeted agents. In other words, the clinical benefits of our chemotherapeutic PDCs may include enhanced or similar efficacy of these untargeted agents as well as an improved adverse event profile. As part of our agreement, Pierre Fabre will provide the proprietary chemotherapeutic payloads, extensive oncology research experience and selected resources, while Cellectar will provide our platform technology and related expertise conjugating oncologic payloads with our PDC small molecule delivery vehicle. In summary, the primary objective of this research collaboration is to co-design a library of PDCs and achieve in vivo proof-of-concept of the superiority of these PDCs to the corresponding untargeted payloads. Pierre Fabre has been granted the option to license any or all of the new PDCs developed as part of our collaboration while Cellectar will own all intellectual property associated with the newly developed PDCs. Jim?
Jim Caruso
Thank you, Jamey. We appreciate the potential upside this collaboration may provide. Pierre Fabre possesses significant oncology R&D capabilities, which we believe will accelerate the development and further validate our PDC platform. We look forward to sharing more about the accomplishments of this collaboration in the future. Relative to our chemotherapeutic conjugate program, it is important to note that our pending patent is scheduled to be published by the U.S. Patent and Trade Office in the second quarter of this year and will provide intellectual property protection for this program through November 2035. In terms of CLR 125, we continue to advance the first phase of the NCI, SBIR grant. This grant has been fully funded, additional research that has allowed us to enhance internal understanding of our delivery platforms. Upon completion of the first phase of the grant, an objective data assessment will be completed regarding the potential clinical promise of CLR 125 as well as a product development and commercialization evaluation which will include third-party expert feedback. This assessment, along with an opportunity cost analysis, will drive our decision regarding the future advancement of this program. Jamey?
Jamey Weichert
Thanks, Jim. As we have previously stated, I-125 is a unique radioisotope with well-described radiobiologic advantages for the treatment of small volume disease, including micro metastases. Our NCI-funded SBIR grant was awarded to allow for the further evaluation of these characteristics, our delivery platform and CLR 125 in a preclinical setting. If warranted, the company may advance the research into the clinic as part of the second phase of the $2.3 million award. The preclinical phase of the research grant was initiated on September 30, 2015 and we are pleased to report the following. We have strengthened the CMC portfolio for CLR 125, which has demonstrated adequate radiochemical yield and purity. We have also initiated stability testing on a final product. We have completed ex vivo tissue bio-distribution studies with the product, as well as in vivo tumor targeting validation with micro PET CT scanning. We also believe we have established the maximum tolerable dose for subsequent efficacy trials. The first phase of the NCI award will be completed by the close of this quarter and we will provide an update in Q3. The company will review the preclinical data and product development and commercialization viability. And once we understand all related resource opportunity costs, we will then determine if initiation of the clinical work as part of the second phase of the grant is warranted. Back to you, Jim.
Jim Caruso
Thanks again, Jamey. In closing, we believe that our company’s progress has positioned Cellectar for a potentially transformational year in 2016 and we remain excited about the near-term milestones, including a Q2 CTX program update providing an early read on in vivo targeting with one of our paclitaxel PDCs, the second quarter publication of our pending patent to bolster our intellectual property portfolio and protect our CTX PDCs through November 2035. Completion of the CLR 125 preclinical in vitro and in vivo research in Q2 with a Q3 program update and most importantly a CLR 131 multiple myeloma study performance update for cohort two in the third quarter of 2016. Additionally, we will provide high level progress reports regarding Pierre Fabre collaboration as appropriate and within the guidelines of our agreement and of course the announcement of additional milestones and events as they occur. Thank you very much for your participation on this call and the continued interest in Cellectar. At this time, Chad, Jamey, Kevin and I welcome any questions you may have. Jules?
Operator
[Operator Instructions] And our first question comes from the line of Jeff Hart with Hart Partners. Your line is open.
Jeff Hart
Hi, good afternoon gentlemen. My question – I have two questions, my first question is unfortunate about the stock prices, I am sure a lot of other people are, but still like what you are doing and remain positive and very optimistic, any comments relative to the stock’s performance recently?
Jim Caruso
Yes. Why don’t I go ahead and take that one. Thanks for asking the question Mr. Hart. We appreciate it. We appreciate your participation on the call. I will tell you that we share your frustration, I understand that our current stock price and clearly undervalued company market cap is frustrating for our shareholders. Taking a step back and starting from a macro perspective, I think it’s fair to say that the macroeconomic environment in general and sector specific dynamics and from macro cap out to companies have generally not been kind. However, I would like to focus on company specific performance as an ultimate value driver to appropriately answer your question. I think it’s important to note that we continue to remain focused on executing our operating plan and quite frankly to-date, the company has achieved each of our publicly established milestones, in fact most of them ahead of guidance including the complete repositioning and re-branding of the company in a relatively short period of time, the transition to an oncology therapeutic R&D focus. We have built a collaboration model based on our PDC platform, which we believe represents the foundation that ultimately will fuel the future growth of the company. And I would like to talk a little bit about 131, it’s our primary valuation driver, which by the way provided impressive Phase 1 data for the treatment of relapse refractory multiple myeloma and we shared that update in the first week of January. And as I cited earlier is a full quarter ahead of guidance. As Kevin pointed out CLR 131 is a unique agent, it has a novel mechanism of action a one-time, one hour infusion in an incurable disease with high unmet medical need with very promising data and we are sitting here with the market caps at $5 million, so I hear that frustration. I believe most companies with an oncology asset in Phase 1. If you look at the benchmarks Mr. Hart generally between 30 to 40 at a minimum with $250 million or greater market caps, of course every situation is unique and they have their own set of unique dynamics. And I think you get my point. In addition what we have that very few other companies have is the free call option and how high is our scenario for our investors represented by our CTX conjugate program. And so I ask you a question, what is the potential value of our platform, if we demonstrate the capacity to convert non-targeted side of toxic agents and the cancer targeting agents which we can alter to therapeutic index, enhance product profiles, specifically reduce adverse events and maintain efficacy so what is that from evaluation perspective. And as a reminder to further validate that concept in December, we did announce the collaboration with Pierre Fabre which validated the science and for those individuals paying attention to potential of our collaboration platform. And also there is a mutual and beneficial sharing the resources there. We believe we have access to extremely interesting natural products chemotherapeutics and we believe we are going to accelerate our research in a more of our delivery platform. So the net is, on all of our stated company value drivers as we can control we can control to the certain extent. People will behave as people will behave. And at the end of the day we have delivered and for the most part delivered on all key milestones ahead of schedule. As I view this from your perspective, another key objective for us was to increase the liquidity of our stock, to allow our stockholders, our shareholders the capacity to move in and out of the stock. And as our trading volume indicates over the last handful of months we made real progress in this area. We see this as a further opportunity. We see Investor Relation activities as a real opportunity for the company and for our shareholders. I think it’s fair to say we have a strong IR plan in place. The plan is ramping up and we are executing versus the plan as we had planned. And I will close on this I mean as in the site or maybe not. As in the site, we recently completed a financing that we believe was highly successful and provides an operating runway will allow the company to turn some very important potentially value driving clinical parts and people must not be paying attention to that as well. The net is, do we have more work to do, absolutely. Do we have very unique assets, yes we do. Do we have a solid operating plan, yes we do. Do we expect to continue to execute as we publicly disclosed against that plan, yes we do. So in summary, I expect and we anticipate our overall performance and positive clinical outcomes to ultimately drive our share price and market cap. So I appreciate your frustration, I also appreciate your confidence and enthusiasm in the team because we believe we have the capacity to move the needle in a very positive way.
Jeff Hart
Thank you, Jim. One last question if I may with the recent new drug approvals for multiple myeloma, is there room for yet another treatment?
Jim Caruso
Why don’t we go ahead and let Kevin do you want to handle that?
Kevin Kozak
Absolutely, thanks Mr. Hart. I actually and call me a rose colored glass wear actually see this as an opportunity rather than a liability. Multiple myeloma remains incurable and the recently developed drugs haven’t altered that fact. Consequently, I think this continues to represent a significant unmet medical need. And just historically, we can review the drugs that have entered the armamentarium. So in 2012, 2013 we saw carfilzomib and pomalidomid. As you know these are not transformative agents. They are simple comparable mechanisms of actions that tried and proved bortezomib and lenalidomide. In 2014, a down year for myeloma, we saw FARYDAK or panobinostat. If you recall in fall of 2014, the FDA actually Oncology Drugs Advisory Committee recommended against approval of FARYDAK because of its really modest activity and it hasn’t really permeated the clinic. 2015 clearly an up year. So, ixazomib one of the three drugs approved in November 2015. This drug of course has the similar mechanism of action as bortezomib, its oral and there is some attraction, but again non-transformative. Potentially transformative of course are the antibodies elotuzumab and daratumumab. First, elotuzumab not shown activity as the single agent and so must be used in combination. And this is the precursor to my comments of opportunity rather than liability. Daratumumab in contrast does have single agent activity. But I think it is these new agents and some of the older agents that represents the opportunity with a novel mechanism of actions agents like CLR 131 that we are genuinely hopeful will demonstrate single agent activity, not only do we have another mechanism of action for an incurable malignancy. So we then have the opportunity to bring some of the other promising agents that have not shown activity such as panobinostat, such as elotuzumab or some of the older agents which have biochemical reasons to be thought to be complementary to CLR 131 such as bortezomib in combination for further development of our agent. So the long answer to your question, but I really do genuinely think there are unmet clinical needs and there remains genuine opportunity both as single agent and in combination with some previously approved agents. I hope that answers your question.
Jeff Hart
Thank you very much gentlemen, it did. Thank you very much.
Operator
Thank you. [Operator Instructions] And I am not showing any further questions at this time. I would now like to turn the call back over to Mr. Jim Caruso for any further remarks.
Jim Caruso
Terrific. Thank you. Thank you all very much for your participation on this call. We appreciate your continued interest in Cellectar. We certainly look forward to our future communications. Thank you.
Operator
Ladies and gentlemen, thank you for participating in today’s conference. This does conclude the program and you may all disconnect. Everyone have a great day.