Cellectar Biosciences, Inc. (CLRB) Q2 2017 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 listen-only mode. Later we will conduct a question-and-answer session and instructions will follow at that time. [Operator Instructions] I would now like to turn the call over to Jules Abraham with JQA Partners. Please go ahead.

Thank you, operator. Good afternoon and thank you for joining us today to review the financial and operational results of Cellectar Biosciences for the second quarter of 2017 on this conference call and live webcast. Earlier today, the company filed its financial statements with the SEC for the quarter ending June 30, 2017 which can be found both on the SEC website and the Investor Relations section of the company's website at www.cellectar.com. In addition, a replay of this conference call will be available on the company website. Joining me today from Cellectar are Jim Caruso, Chief Executive Officer; Chad Kolean, Cellectar's Vice President and Chief Financial Officer; John Friend, M.D., Vice President and Chief Medical Officer and Jarrod Longcor, Cellectar's 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. In addition, there may be forward-looking statements during the Q&A session following 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 Cellectar. 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 all participants for joining us today for a review of our second quarter 2017 financial and corporate results. We have continued to realign our investments into programs with the greatest potential to accelerate Cellectar's growth and development and are encouraged by the pace of this repositioning and execution on our strategic plan. The CLR 130 clinical data observed to-date have been promising and we look forward to announcing additional results from our Phase I and Phase II trials. We are also driving value creation through strategic collaborations to enrich the company's small molecule pipeline with proprietary assets. To this end, we remain pleased with our ongoing relationship with Pierre Fabre and the progress achieved developing new PDCs, utilizing the proprietary payloads provided by Pierre Fabre. Two weeks ago we announced our collaboration with Avicenna Oncology, a leading cancer targeting research and development company. This deal is also strategically important to Cellectar on multiple levels and Jarrod Longcor, Senior Vice President of Corporate Development and Operations will further provide details later in the call. In a parallel path, we continued to drive our lead PDC program, CLR 131, currently in a Phase 1 trial for multiple myeloma to establish the drug's maximum tolerated single dose and in a Phase II for multiple myeloma and other orphan designated blood cancers with the potential for a second dose. We continue to be encouraged with the drug's performance and John Friend, our Chief Medical Officer will provide study details as well as further updates on this program. Throughout the last two years, we have also achieved 16 intellectual property milestones which further protect our PDC platform and proprietary PDCs in the US as well as other strategic countries. It is also important to reiterate that each new PDC will be viewed as a new chemical entity. From a financial perspective, we maintain our guidance that our cash on hand will allow us to maintain operations into the second quarter of 2018. CFO Chad Kolean will provide further details including a full financial summary of our second quarter. I will then provide closing comments, after which the entire executive team will be available to answer your question. At this time, I'd like to turn the call over to Cellectar's CFO Chad Kolean for an overview of the first [ph] quarter 2017 financials.

Thank you, Jim. Before discussing our results for the second quarter, I want to comment on the special meeting of stockholders that will be held on September 12 at our offices here in Madison as it is an important process for all of our investors. The reason for the meeting is to fully and completely address any concerns that may arise regarding the vote that increased our authorized shares to 80 million as part of our May 31 Annual Meeting. I want to make it clear that the only purpose of this special meeting is to ratify or affirm the vote from the annual meeting where investors approved the increase in the number of authorized shares. In other words, the proposal being voted on at the special meeting on September 12 does not represent any new action by the company whatsoever. It is entirely focused on ensuring that the stockholders approval was made based upon a clear understanding of that proposal. In the proxy document that we sent to all stockholders in preparation for the annual meeting in May, there was an inadvertent drafting error that could have caused confusion for the reader. In particular, the May proxy statement suggested that brokers and other nominees who hold shares in Street name on behalf of their clients would not have discretionary authority to vote those shares with respect to the approval of the proposal to increase to share authorization to 80 million even though it had been the company's intent to state that consistent with the applicable rules, discretionary voting is permitted. As a result and to ensure that there is no concern or confusion regarding the communications with stockholders prior to the annual meeting, we decided to ask stockholders to ratify the vote in the upcoming special meeting which is the sole purpose of that meeting. The management team and the company's Board of Directors ask that you review the materials when you receive them and recommended that you support the company by voting for the proposal. Now I want to turn to our operating results for the second quarter of 2017. Research and development expenses were 2.2 million, an increase of 1.2 million from the prior year. We undertook two substantial initiatives last year, the primary drivers of this increased spending. The first is the Phase II clinical trial in hematologic malignancies that we initiated at the end of the first quarter and the second is the establishment of a production capability that can address the increased CLR 131 for ongoing and any future clinical trials as well as adequately provide product to support commercialization. Both of these initiatives are incremental to our ongoing Phase I relapse refractory both for myeloma clinical trial for which the expense was relatively consistent with the prior year were 1.0 million in the quarter just ended, an improvement of 0.3 million from the second quarter of 2016. The reduction in expense was primarily a result of lower professional fees for consulting, legal and accounting services. As a result of our increased R&D spending, our loss for operations increased to 3.2 million for the second quarter of 2017 as compared to the second quarter of 2016 when our operating loss was 2.3 million, this increase was entirely planned by the company. Other income for the current quarter was 0.1 million, while other income was 0.2 million for the second quarter of 2016. The small gains for both periods were primarily a result of non-cash adjustments to the value of certain securities treated as derivative liabilities on the company's balance sheet. Our loss for the quarter was 3.1 million or $0.23 per share. For the second quarter of 2016, the net boss was 2.1 million or $0.49 per share. On June 30, 2017, we had 8.3 million in cash and cash equivalents on hand, while as of December 31, 2016, we had 11.4 million in cash and cash equivalents. We are reaffirming our estimate that our available cash and cash equivalents should fund the company's planned operations into the second quarter of 2018. Additional capital will be required to complete planned pre-clinical research and further clinical development of key assets. And now I will turn the call back over to Jim.

Thank you, Chad. As you know we are now in the fourth cohort of our Phase I MTD trial of CLR 131 for the treatment of relapse refractory multiple myeloma and have initiated our NCI-supported Phase II trial as well. John Friend will now provide us with an update on those clinical programs.

Thank you, Jim. Good afternoon everyone, although we have witnessed great advances over the past decade in the treatment of various cancers, the resistance and refractory nature of multiple myeloma and other B-cell malignancies has posed a very challenging hurdle to overcome. Often the time progression accelerates after each successive round of therapy or trying a new agent or combination thereof. Given that, currently there are limited treatment options available that offer a significant improvement on overall survival in the refractory setting. And based on the clinical data already observed with a single infusion of CLR 131 in heavily pretreated or relapsed refractory patient population, we remain optimistic regarding the potential benefit CLR 131 may provide to patients living with cancer. As Jim stated, I would like to provide you with a review of our ongoing clinical study. As a reminder, the current Phase I study is an open label dose escalation study in relapsed or refractory multiple myeloma patients. The primary objective of the study is to determine the safety and tolerability of a single 30- minute infusion of CLR 131 with and without dexamethasone. These early studies help guide us in the choice of a dosing regimen to move forward into Phase II and frequently provide us with a hint of potential efficacies that shows improved progression free survival and overall survival. We believe that based on our evaluation to-date both safety and efficacy signals continue to be extremely encouraging. The safety and efficacy of the third cohort was presented at the first quarter call three months ago and I'm pleased to say four cohort is fully enrolled. These patients receive 31.25 millicurie per meter squared to the compound and we expect to report initial results from this cohort by the close of third quarter 2017, in line with our previous guidance. As for the remaining cohorts, after a single infusion of 12.5 millicurie per meter squared, patients in the first cohort have achieved an impressive median overall survival of 22.5 months to-date. Patients from the second and third cohorts who received 18.75 millicurie per meter squared and 25 millicurie per meter squared doses have experienced median overall survival of 13.2 months and 6.7 months respectively. We continue to collect overall survival on all evaluable trial participants and will provide timely updates as appropriate. With regard to NCI supported Phase II study of CLR 131 in multiple myeloma and other hematologic malignancies, we initiated the trial on March 30, 2017 and it is active and enrolling. It is being conducted at approximately 10 to 15 top cancer centers across the United States for patients with a variety of orphan designated relapse or refractory hematologic cancers. The study's primary endpoint is clinical benefit rate with additional informative secondary endpoints of overall response rate, progression free survival, median overall survival and other markers of efficacy. Similar to our Phase I study, all patients will receive a single 25 millicurie per meter squared dose of CLR. But unlike the Phase I study, an optional second dose of 25 millicurie per meter squared can be infused approximately 75 to 180 days later. The hematologic cancer studied in the trial include multiple myeloma, chronic lymphocytic leukemia, small lymphocytic lymphoma, lymphoplasmacytic lymphoma, marginal zone lymphoma, mantle cell lymphoma, and potentially diffuse large B-cell lymphoma. In addition to the CLR 131 infusion, multiple myeloma patients will receive 40 milligram oral dexamethasone weekly for up to 12 weeks. Efficacy responses will be determined by the latest International Multiple Myeloma Working Group criteria. Efficacy for all lymphoma patients will be determined according to the Lugano criteria. We look forward to provide an update on both of these trials as they become available. With that, it's my pleasure to turn the call over to Jim.

Thank you for the summary of our progress with CLR 131, John. As we consistently state, our clinical focus remains on the successful execution of the development of CLR 131 for the treatment of relapsed, refractory multiple myeloma and other select hematologic malignancies. We're very pleased with our continued momentum toward that and look forward to sharing future updates. At this time, I'd like to turn the call over to Jarrod Longcor, Cellectar's Senior Vice President of Corporate Development and Operations to discuss our Pierre Fabre and Avicenna Oncology collaborations as well as an update on select pre-clinical programs.

Thank you, Jim. As was mentioned by Jim earlier in this call, we have focused both our partnering and research and discovery strategies on long-term value generation. This will come in the form of revenues via upfronts, milestones and royalties as well as access to molecules, or payloads for the PDCs that Cellectar can develop on its own or in collaboration, additionally defraying R&D expenditures and providing more details in general for the company. To this end, both Pierre Fabre and our recently announced collaboration with Basel, Switzerland based Avicenna Oncology provides such strategic benefits. The deal with Avicenna provides a unique opportunity to collaborate with experts in the antibody drug conjugation or ADC delivery field and further validate our next generation delivery platform with new proprietary payloads to potentially create new products for the treatment of various solid tumors. As part of the collaboration, we will examine the two delivery modalities side-by-side with the same payload, which will provide Cellectar with an opportunity to further validate the PDC platform and to generate key data that would differentiate this method of targeted delivery versus that of the antibody drug conjugates, which we believe will further demonstrate that our PDC platform is the next generation of targeted therapies. Under the terms of the deal, Avicenna will provide their novel chemotherapy payloads through Cellectar. We will then leverage our expertise and chemical conjugation to link the molecules through our phospholipid ether or PDC platform and put these molecules through our rapid iterative in vitro and in vivo screening process to identify the best PDC. These PDCs will then be tested alongside the previously designed ADC or antibody drug conjugates with the same payload provided by Avicenna. Additionally, the collaboration allows both companies to have the option to advance the development of any of the newly congregated molecules, PDCs, either globally or regionally. Therefore, this collaboration also provides Cellectar with a very interesting and potent payload to which we would not otherwise have access. We look forward to combining our respective companies' expertise to better understand the potential benefits of our next generation targeting platform PDCs versus that of the ADC delivery. With regard to our collaboration with Pierre Fabre, we continue to make significant advances. We have identified a select number of PDCs that show the potential to have the preferred therapeutic window and potential efficacy. In terms of our other preclinical activities, we have expanded our PDC research to include a new program involving a novel payload internally. Furthermore, we continue to strengthen our research capacity to leverage our CLR CTX conjugate programs to allow future collaboration as well as our own in-house proprietary small molecule research. We also remain focused on broadening the potential of CLR 131 and continue to perform research to identify optimal dosing regime, tumor types and ideal drugs to be used in combination with CLR 131. Over the preceding quarter, we completed a handful of in vivo experiments, evaluating CLR 131 in various solid tumors, including ovarian, prostate, bladder, lung cancer and Glioma. CLR 131 has shown excellent activity in each of these models as a single agent. In addition, we have explored the use of multiple doses in several of these tumor types. Here again, we have seen that CLR 131, when given in multiple doses, and/or fractionated doses of two or three doses provide excellent single agent effect with an even greater efficacy over the single dose, including a greater than doubling of survival in several solid tumor models. We expect to have further updates on all of these programs in the weeks and months to come. I'd like to now return the call to Jim.

Thank you, Jarrod. As always, we look forward to announcing additional company milestones and events as they occur. In the meantime, I'd like to thank you very much for your participation on this call and your continued interest in Cellectar. At this time, Chad, John, Jarrod and I welcome any questions that you may have.

[Operator Instructions] Our first question is from Wangzhi Li with Ladenburg. Your line is now open.

Yeah. I have a few. Firstly, just touch on the Avicenna collaboration. So you mentioned one reason for the partnership that you can compare the PDC with the ADC head to head, just wonder if you can provide more color in terms of what exactly you can compare, what do you want to compare between the PDC and the ADC and why it's important for you?

Terrific. Great question, Wangzhi. We appreciate it. We're very excited about the Avicenna collaboration for a number of reasons. And the one question that you just cited is of particular interest for us as well as some other clear benefits to the company as well. The gentleman who orchestrated that collaboration is Jarrod Longcor and I'll ask him to provide additional color.

Thank you, Jim. Thank you, Wangzhi. I think the best way to describe, there's a host of data that will come out of that head to head comparison, but I think probably two of the key ones that will be beneficial to us is historically it's often been stated in literature and other places that with antibody drug conjugates, they see only about 1% of the material that gets to the exposed, to the tumor and it's exposed to the tumor, is actually taken up into tumor cells. One of the things we would like to see and we know that we're seeing a much higher rate of uptake than that with our molecule alone, so what would this allow us to do is see that in a exactly same molecule other than an antibody versus the phospholipid ether molecule. Everything else being the same, we'll see what the difference is in that uptake in CV potential enhancement of the uptake into the tumor with our molecule versus an ADC. The other part of that is clearly more on the efficacy side, so obviously to deliver more to the tumor and into the tumor, therefore, we should see an increased efficacy and we look to see that as part of the outcome as well. Furthermore, we think that as we've talked about in the past, we believe these molecules, our PDCs provide an increase in therapeutic window, not only over the base, what I'll call parent molecule or what is the payload, when it's given by itself, but also in general potentially against the antibody drug conjugates, while they are targeted with an antibody, the epitopes that they target can also be on normal tissue as well.

I think - thank you, Jarrod. The only other elements I would add to that, just in terms of the benefits of this collaboration in general really gives us an opportunity to gather additional intelligence with real ADC experts as part of this compare and contrast and additionally, it really provides us access to proprietary molecules that provide us with the potential to create new phospholipid drug conjugates or PDCs, in this particular case, we believe high potential for the treatment of solid tumors.

So maybe it's early, but any color in terms of potential timeline, do you get those type of data you just mentioned?

Yes. Sure. It is too early to say that. To be honest, the collaboration has really just been kicked off. As you know, we made the announcement, however, the real meat and potatoes of what we're going to be doing is going to be now down here in September when we really get started cranking through some of this and moving forward. So we hope to have some outputs, perhaps early next year to the middle part of next year sort of timeframe at this juncture and then going as fast as we can from that.

I will say this Wangzhi, based on the work of the team via our collaboration with Pierre Fabre, we really have put an infrastructure in place that now allows us to really accelerate the level of pre-clinical research from the conjugation of these compounds. And based on the relationships that we put in place internally as well as with third-party players, we can accelerate the research in this particular area. So we're excited about the collaboration and we think we'll be able to get more done sooner rather than later.

And then shifting gear to another question on the Phase II trial, you mention the primary endpoint, benefits raised, could you clarify that means disease control rates or it's a different meaning?

So why don't I turn that over to Dr. Friend.

Thank you, Wangzhi. Yes. You're correct. It is the disease control, which is a combination of complete response, partial response and stable disease. So you're correct. Yeah.

And the last question is, for the two, you mentioned potentially included DLBCL, I just wonder you have more color in terms of when you will decide to include DLBCL or not and what's the criteria you're looking there?

Yes. We did say potentially and I think that decision will come probably early 2018, the criteria in terms of diffuse B-cell, we are actually waiting, as you know, we are looking for those first three or four cohort groups to expand out to the diffuse B-cell at this point.

Said another way Wangzhi, we're really focusing on the other selected hematologic malignancies that John cited earlier in his review of CLR 131. Once we get our arms around because we believe those are the cleanest near-term opportunities for us, once we get a better understanding there, then we'll advance the program.

And I'm showing no further questions. I would now like to turn the call back to Jim Caruso for any further remarks.

All right. Terrific. Well, first of all, thank you to all of the participants. We certainly appreciate your continued interest in Cellectar, your continued belief in our technology, which we believe will have a meaningful impact on disease with high unmet medical need in the patients that suffer from these challenging diseases. Thanks again. We look forward to our next call.

Ladies and gentlemen, thank you for participating in today's conference. You may all disconnect. Everyone, have a good day.