Cellectar Biosciences, Inc. (CLRB) Q2 2016 Earnings Report, Transcript and Summary

Good day, ladies and gentlemen and welcome to the Cellectar Second Quarter Earnings Conference Call. At this time, all participants are in a listen-only mode. [Operator Instructions] Later, we will conduct a question-and-answer session and instructions will be given at that time. I would now like to introduce your host for today’s conference, Mr. Jules Abraham from JQA Partners. Sir, please go ahead.

Thank you, Liz. Good morning and welcome to Cellectar Biosciences' 2016 second quarter conference call and webcast. The Company filed its financial statements for the quarter ended June 30, 2016 with the SEC on Thursday, August 11. 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 are Jim Caruso, Chief Executive Officer; Chad Kolean, Chief Financial Officer; and Dr. Kevin Kozak, Chief Medical Officer; and Jarrod Longcor, Senior Vice President of Corporate Development and Operations. 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 the company’s 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 the Company’s 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 the Company 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 today for our second quarter 2016 call. Throughout the first half of 2016, we continue to align our corporate objectives, team culture and company resources to better optimize the potential and value of our corporate assets. In assessing our progress over the last two quarters, I believe our team has been effectively executing our corporate business plan, including our therapeutic focused research and development program, the advancement of our delivery platform technology, as well as human resource deployment and resulting productivity and performance enhancements. We look forward to providing additional insight on the Company's performance on today's call. To briefly outline the agenda. We'll start by having our CFO, Chad Kolean provide a financial summary, including 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 lead PDC currently in a Phase 1 clinical study for the treatment of relapsed/refractory multiple myeloma. Kevin will also provide additional background regarding NCI's agreement with Cellectar’s recommendation to invest the $2 million Fast-Track Award to accelerate and expand the research of the company's lead product candidate CLR 131 in hematologic malignancies. This is an enormously significant win for the company and ultimately patients that may benefit from CLR 131 treatment. In addition, Jarrod Longcor, our recently hired Senior Vice President of Corporate Development and Operations will provide a progress report on our CLR/CTX chemotherapeutic conjugate program. An update on the Pierre Fabre collaboration as well as an overview of our Q2 intellectual property advancements, which have further strengthened and expanded our intellectual property portfolio. As always at the conclusion of the call, the executive team will be available to answer your questions. Prior to turning the call over to Chad, I would like to formally introduce Jarrod Longcor, the Cellectar team is excited to have successfully recruited such a high performance industry veteran to the company. Jarrod possesses extensive clinical operations and partnership deal experience and has either acted as the lead or participated in more than 40 industry collaborations. Jarrod's academic training is equally impressive and includes a B.S. from Dickinson College, an M.S. from Boston University School of Medicine and an M.B.A. from Saint Joseph's University's Haub School of Business. Jarrod has leveraged this unique blend of formal science and business training into an established track record of professional industry success. Importantly, Jarrod has quickly established himself as an integral member of our leadership team and he’s already playing a key role in further professionalizing the company's corporate operations. I look forward to both his leadership and future company contributions. At this time, I'd like to turn the call over to our CFO, Chad Kolean for our financial update.

Thank you, Jim. Prior to reviewing the results for the second quarter, I will begin by discussing the recent financing and other events that occurred during this quarter which resulted in a strengthening of the company's capital structure. On our last earnings call, we’re reported the results of our underwritten public offering that closed on April 20, 2016 which generated over $8 million in gross proceeds and $7.2 million in net proceeds. As part of the operating the company sold 1,871,321 shares of common stock at $2.13 and 1,908,021 pre-funded warrants to purchase common stock, all of these pre-funded warrants were exercised for common stock within five weeks of the deal closing and the total value received by the company as a result of their exercises also $2.13 per share. Included in the offering, the purchase of each securities investors also received an April 2016 Series A warrant for each share of common stock or pre-funded warrant that they purchased. These warrants have a strike price of $3.04, a five-year life, and are callable by the company under certain circumstances. A total of 3,779,342 April 2016 Series A warrants were issued and they are traded on the NASDAQ Capital Market under the ticker symbol CLRBZ. In addition to the successful financing, we also focused on strengthening our overall capital structure within the quarter. As of March 31, 2016, the company has three different series of outstanding warrants that possessed price protection feature; the October 2015 Series A warrants, the October 2015 Series B pre-funded warrant, and the February 2013 Series B warrants. Between the closing of the financing on April 20, 2016, and the conclusion of the second quarter, over 40% of the October 2015 Series A warrants, all of the October 2015 Series B pre-funded warrants, and approximately one-third of the February 2013 warrants were exercised. As a further capital structure improvement and in exchange for additional warrants, the holders of the October 2015 Series A warrants agreed to amend them such that they no longer possess a price protection feature. Therefore, those warrants are no longer accounted for as derivatives and were reclassified to equity. The result of these activates is that as of June 30, 2016, we have reduced the quantity of outstanding price protected warrant to a total of 38,750, a substantial reduction from the approximately 7,100 warrants that were outstanding prior to the company's action and more of an exercise that were subject to price protection. Additionally, investors exercised a portion of the CLRBZ warrants that were issued in the April 2016 finance. The company's focused effort to strengthen our capital structure resulted in the exercise of the above listed warrants, resulting in the exercise of the above listed warrants yielded significant positive results. Most importantly the price protected exercised warrant were previously a accounted for as derivative liability, whereas now they are accounted for as stockholders to equity. The total beneficial impact from the derivative warrants that were either exercised or amended in the quarter resulted in a reclassification of approximately $1.4 million from liabilities to equity. This represents a substantial improvement in the company's equity balance as well as it eliminates the liability associated with warrants. In addition, the warrant exercised generated an additional $650,000 of additional funding that increased equity for the company. Now for our operating results for the second quarter of 2016. Research and development expenses for the current quarter were $1 million, a reduction of approximately $0.4 million from the second quarter last year. This improvement which is consistent with what we saw in the first quarter is result of our strategic work in third and fourth quarter’s last year to drive our therapeutic clinical trials and research and development efforts. General and administrative expenses for the quarter totaled $1.4 million, which is $0.6 million higher than the second quarter of 2016. Significant drivers of this increase were specific charges related to legal fees and other consulting services that will not recur, in addition to increase personnel investments. Our loss from operations was $2.3 million for the second quarter, which is consistent with the same quarter of last year. Other income was $0.2 million for the second quarter of 2016 as compared to essentially zero in the second quarter of last year. In last quarter's conference call we indicated that based upon the warrant restructuring which is further enhanced by the recent warrant exercise. We expected the non-cash other income in loss activity there is a result of the derivative warrants treatment would be substantially reduced going forward, a result this quarter demonstrate that. Our net loss for the quarter ended June 30, 2016, was $2.1 million or $0.49 per share. On the quarter ended June 30, 2015, we reported a net loss of $2.3 million or $3.02 per share. As of June 30, 2016, we had $7.9 million in cash and cash equivalents on hand compared to $3.9 million in cash and cash equivalents at December 31, 2015. 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 planned pre-clinical research and further clinical development or key assets. Now I'll turn the call back to Jim.

Thank you, Chad. Prior to discussing our planned milestones from Q3, 2016 through the first half of 2017, let's first review key achievements of the past quarter. In addition to strengthening our capital structure and closing a successful $8 million financing in April, enrollment in our CLR 131 relapsed/refractory multiple myeloma study continues to progress as planned. We remain excited about the potential clinical value, CLR 131 maybe possessed for patients diagnosed with multiple myeloma as well as hematological malignancies and look forward to sharing the impending cohort 2 data. We also reported key patent views encouraging in vivo cancer targeting data for CLR 1602, which is one of our in-house paclitaxel conjugates, as well as the successful completion of the first phase of our $2.3 million NCI Fast-Track award. As just stated, in Q2 we received three important notifications from the United States Patent and Trademark Office or the USPTO. First, we received confirmation that our patent application protecting assets drive from our CLR CTX program including our delivery vehicle conjugated with cytotoxic molecules was published. The company was then issued a patent for our CLR 1600 series conjugates, combining the company’s delivery vehicle with paclitaxel, as well as another issued patent which provides coverage for the treatment of cancer stem cells for CLR 131 and CLR 125 in combination with external beam treatment. During the quarter we also reported in vivo cancer targeting data which demonstrated that while early our research with the CTX program continues to produce promising data. Notably, we also recently reported that the NCI was in agreement with the company’s recommendation to shift a $2 million Fast-Track award from funding pre-clinical studies for CLR 125 to funding a Phase 2 clinical trial of CLR 131 in hematologic malignancies. This transition of funding from CLR 125 to CLR 131 is an extremely important win for Cellectar. It allows us to both accelerate and expand the clinical research of our lead product candidate in hematologic malignancies with $2 million of non-dilutive government funding. In summary, we have successfully achieved, and in some areas exceeded full identified Q2 objectives, as well as reported additional milestones regarding our intellectual property portfolio including a strategically important patent publication as well as the USPTO’s issuance of two additional patent. We will now transition to a more detailed discussion of our research and clinical development program updates and we’ll begin with Dr. Kevin Kozak, our Chief Medical Officer to further discuss our ongoing Phase 1 relapsed/refractory multiple myeloma clinical study of CLR 131. And provide a few comments regarding our planned NCI supported Phase 2 clinical study in relapsed/refractory multiple myeloma and other hematologic malignancies. Kevin?

Thanks, Jim. So it’s important to note that multiple myeloma is an incurable malignancy of plasma cells that’s diagnosed in approximately 30,000 Americans each year qualifying it as an orphan disease. This hematologic malignancy is characterized by both diffuse distribution and radio sensitivity suggesting a systemic radio therapeutic may have a role in the therapeutic armamentarium for multiple myeloma. While available 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 relapsed and refractory settings. As a result, and despite recent expansion in treatment options, there remains a high unmet medical need. Reviewing recent clinical data regarding relapsed/refractory multiple myeloma five out of six recently approved drugs demonstrated monotherapy responses in this settings but in less than 25% of relapsed/refractory patients. Three of those approved products showed monotherapy responses in less than 8% of the population. These data clearly demonstrate the importance of Cellectar’s research of CLR 131 in relapsed/refractory myeloma and for these patients. Multiple myeloma is a difficult to treat disease in the relapsed/refractory setting treatment challenge is substantial. Given the limited treatment options currently available to these patients and based on what we’ve already observed with CLR 131 in the setting we remain optimistic and encouraged regarding the potential benefits of CLR 131 may provide the patients with relapsed/refractory myeloma. As you may recall we are currently engaged in a Phase 1 clinical study in this patient population evaluating the safety and tolerability of four escalating doses of CLR 131. The first cohort received a dose of 12.5 millicurie with all four valuable patients achieving stable disease for an average of three months. We’re currently enrolling into our second cohort testing a dose of 18.75 millicurie. Enrollment in this study continues to proceed well and we intend to provide an update on the second cohort by the end of the third quarter. In early July the company held an Investigators Meeting during which participants expressed enthusiasm for the process of the study and critically for both CLR 131’s early activity and safety signals. Please recall the study is designed to evaluate CLR 131 in a heavily pre-treated patient population with progressive disease. The investigator optimism expressed during the meeting was based on multiple factors. First and foremost the CLR 131’s novel mechanism of action complimented by the targeted delivery provided by our patented PDC platform. The novel mechanism of action allows CLR 131 to be uniquely positioned in this patient population where the malignancy has become resistant to other classes of therapy and there exists few if any treatment alternatives. Additionally the clinicians felt the convenience of a single 30 minute infusion provides a meaningful benefit in the quality of life afforded to these patients. With no additional time required to receive further infusions and only routine follow-up visits required some of these patients are able to return to a more normalized lifestyle. This is in contrast to other therapies where patients may be required to see complex multi-drug, multi-dose regimens with their attendant toxicities and logistical challenges. Given our genuine optimism of CLR 131 in relapsed/refractory multiple myeloma, we look forward to further assessing the drugs performance in future patient cohorts and additional hematologic malignancies. Anecdotally that helps to confirm our assertion that PDC platform does indeed have a more targeted delivery, limiting exposure to the cancer cells and cancer stem cells rather than healthy cells. Finally as Jim previously mentioned the National Cancer Institute agreed with company’s recommendation to transition the $2 million Research Funding Award from CLR 125 to our lead compound CLR 131. This contract provides a necessary funding to conduct a Phase 2 clinical study of CLR 131 in hematologic malignancies. We look forward to providing additional study detail in the near future including the hematologic cancers to be researched, trial design and timing of the Phase 2 clinical study initiation. With that, I'm pleased to turn the call back over to Jim.

Thank you, Kevin. We remained focused on the execution of our current Phase 1 clinical study of CLR 131 for the treatment of multiple myeloma and certainly look forward to providing further updates. We are equally excited about our NCI supported Phase 2 clinical study in hematologic malignancies and as Kevin states we look forward to providing additional detail. Now I'd like to ask, Jarrod Longcor to provide further information on our CTX program progressed with our Pierre Fabre research collaboration and intellectual property stuff.

Thank you, Jim. As Jim previously mentioned during the previous quarter, we significantly expanded and strengthened our patent portfolio. First we received confirmation from the U.S. Patent and Trademark Office or USPTO of the publication of our patent application for the use of our PDC delivery vehicle conjugated with any existing or future cytotoxic agents. This patent provides both composition of matter and method of use protection for both our current and future PDCs will provide protection when issued were approximately two decades. This patent will be a key component of our partnering platform going forward. Additionally the USPTO issued patent for CLR 1600 series PDC’s protecting assets generated through the conjugation of our delivery vehicle with paclitaxel. This patent provides protection for our lead chemotherapeutic PDC program at least until November 2035. The patent demonstrates how conjugating chemotherapeutic molecules, the phospholipid ether delivery vehicle can provide new or extended existing patent protection. Finally the USPTO granted Cellectar’s patent application for both composition of matter and method of use for our radiotherapeutic program, which provides patent protection among other assets for our clinical stage product candidate CLR 131. This patent allows us to combine CLR 131 with external beam radiation therapy to potentially increase the efficacy of both techniques in a number of different tumor types. Cellectar will maintain patent protection from this granted patent until at least June 2030. Now moving on to an update of our PDC chemotherapeutic or as we call it our CLR/CTX programs, since our last update we continue to make excellent progress. We believe our tumor targeting delivery platform will allow us to combine the PDC delivery vehicle with a multitude of chemotherapeutic agents converting untargeted agents into novel targeted agents. We believe that these new targeted agents or PDCs will improve the therapeutic index versus the original untargeted agents, and in some cases result in improved efficacy and/or safety. This approach also allows us to extend market exclusively by creating new intellectual property and patent life. To-date, we have progressed a number of internally developed programs with on-market generic chemotherapeutics as well as several novel proprietary agents within our collaboration with Pierre Fabre. Our focus with our internally developed programs has been to develop our paclitaxel series of PDCs and further validate the platform in vivo. Additionally we’ve expanded our research capacity to allow us to assess a greater number of chemotherapeutic PDCs in vitro and in vivo. Our PDCs have previously demonstrated a six- to ten-fold increase in uptick into malignant cells over normal cells depending on the exact tumor type. We believe even a modest shift and targeting could result in a meaningful improvement in both efficacy and in the adverse event profile for some chemotherapeutics. As you may recall following some initial studies, we selected CLR 1602 as our lead molecule from the paclitaxel series of PDCs and has successfully synthesized a deuterated version of this molecule to allow us to efficiently determine CLR 1602’s tumor targeting ability. In collaboration with our selected CROs, we evaluated CLR 1602 head-to-head with a deuterated version of paclitaxel and xenogram disease model of human breast cancer. This study was designed to assess and compare the tissue distribution and plasma packed pharmacokinetics following intravenous administration of a sub therapeutic equivalent molar concentration of both molecules. We evaluated six different time points in 10 different – in 10 disease models in each group. The results of this quantitative in vivo assessment shows CLR 1602 targeted and accumulated in the tumors cells are 20 to 30 times more efficient, more effectively in paclitaxel [Audio Dip] showed much greater plasma exposure in paclitaxel alone and had a longer elimination half way. We believe the targeting features of the PDC combined with these features that just result in greater exposure to and greater accumulation within the tumor cells. These results suggest that CLR 1602 have potential to be dosed at significantly lower amounts with plasma paclitaxel alone while achieving similar or better effects. The reduced dose could also improve tolerability as compared to paclitaxel alone. The next step in the development of CLR 1602 will be conducted a series of studies evaluating formulation, different linkers and efficacy studies in this and other in vivo models of cancer. Additional during this time, we have continued to progress our collaboration with Pierre Fabre. This collaboration was announced in December 2015 and it was initially initiated during the first quarter of 2016. This collaboration is the first step in our plant partnering model which will allow us to advance our research and development efforts and key molecules to strategic partnerships. We are very excited about this synergistic relationship as it is with Pierre Fabre. As you may recall the objective of this collaboration is to leverage Cellectar’s PDC platform with the selection of Pierre Fabre’s proprietary chemotherapeutics to achieve targeted delivery of these molecules from the tumor and enhancing the product profile. Likewise CLR 1602, these molecules are being designed to achieve significantly more uptake by the tumor than the original chemotherapeutic alone. This should provide both an improvement in the safety profile of this compound and potential increase their efficacy. As part of the collaboration, Pierre Fabre provided their proprietary chemotherapeutics, their extensive oncology research experience, and selective reserves – resources while Cellectar is providing our PDC platform technology, our oncology drug development experience and our expertise in conjugating oncologic payloads with our PDC small molecules deliver vehicle. To-date working with the lead molecule from Pierre Fabre, we have completed large scale of synthesis and conjugation of a new series of PDCs, we will be initiating in vitro studies to select the best molecules to advance in vivo studies in the near future. It is important to know that this series of molecules represents brand new intellectual property. With that, I’d like to turn call back to Jim.

Thank you, Jarrod. During our last call, I committed to continued progress with both corporate and product development milestones over the course of the year. And I believe we can safely say that the team has made good on that commitment. Obviously we still have a number of clinical milestones ahead and much work yet to do. However, we believe that the company is positioned nicely for future growth. For the remainder of the year, we can anticipate the following events. A clinical performance update on cohort 2 of our Phase 1 multiple myeloma study of CLR 131; initiation of our study’s third cohort at 25 millicurie per meter square; announcement of the clinical study design and other trial details for the Phase 2 clinical study of CLR 131 in multiple myeloma and other hematologic cancers; the announcement of additional milestones and events as they occur. We also plan on the first half of 2017 as being an eventful period for Cellectar Biosciences and includes the initiation of our Phase 2 clinical trial of CLR 131 in multiple myeloma and other hematologic malignancies. A clinical performance update on cohort 3 of our Phase 1 multiple myeloma study of CLR 131; initiation of cohort 4 as required for study protocol. Progress reports regarding our 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. Finally, as many of you know, Cellectar’s founder, as well as part-time Chief Scientific Officer, Dr Jamey Weichert, departed Cellectar last month in order to pursue other interim. I would like to take this opportunity to express our gratitude to Jamey for his over 10 years of service to Cellectar and we wish him the very best in his future endeavors. With that, I'd like to thank you very much for your participation on this call and your continued interest in Cellectar. At this time, Chad, Kevin, Jarrod, and I welcome any questions that you may have.

[Operator Instructions] We have a question from line of Bert Hazlett with Ladenburg. Your line is now open.

Yes. Congratulations on all the progress and thank you for the call and the detail. Could you maybe elucidate a little bit more about – I understand there would be a significant amount of specifics coming for the Phase 2 for 131 again, and congratulations on being able to shift the NCI funding there. Do you have an idea of what the Phase 2 might look like at this point? And any general commentary about trial design would be helpful there. Thank you.

Terrific, Bert. Good morning, thank you for joining our conference and obviously we appreciate your interest and your question. We are extremely excited obviously about the opportunity that NCI provided us this transition a $2 million essentially to our lead product candidates CLR 131 as intriguing as CLR 125 is the benefit of investing $2 million to accelerate advanced CLR 131 in an area that we believe we have significant clinical utility potential in the hematologic side of the disease is very exciting for us. And we – Bert, by design, we have not provided a lot of color on with that, Phase 2 trial will look like. But what I will do is ask Jarrod to make a few comments without providing any real detail.

Yes.

Thank you, Jim. Yes, Bert, and thank you for the question. I'll say the hard part here is obviously the transition with NCI has just taken place and we are just really beginning to look at the development plan and exactly how we would design that Phase 2. I think the key aspect that I would say as we've sort of alluded to is that we will be looking at both subsets of multiple myeloma as well as additional hematologic malignancies in that study. Beyond that there is really very little detail that we have at this time, but we are working with CRO's to really put together the appropriate protocol and put something out rather quickly.

So our plan Bert is in the October timeframe to provide greater detail on what that study looks like, you can be assured that we're going to take an interesting look at multiple myeloma as well as other hematologic malignancies that we believe this [Audio Dip] based on what we’ve seen today. So we are very excited about it, appreciative of the question.

Okay. Thanks. We look forward for further detail.

All right. Thank you, Bert.

[Operator Instructions] And I’m showing no further questions. This concludes our question-and-answer session. Ladies and gentlemen, thank you for participating in today’s conference. This concludes the program and you may now disconnect. Everyone have a great day.