Earnings Labs

Cellectar Biosciences, Inc. (CLRB)

Q1 2017 Earnings Call· Thu, May 11, 2017

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Transcript

Operator

Operator

Good day, ladies and gentlemen and welcome to the Cellectar First Quarter 2017 Financial and Corporate Performance Conference Call. At this time, all participants are in listen-only mode. [Operator Instructions] As a reminder, this conference maybe recorded. It’s now my pleasure to hand the conference over to Mr. Jules Abraham from JQA Partners. Sir, please proceed.

Jules Abraham

Analyst

Thank you, Brian. Good afternoon and thank you for joining us today to review the financial and operational results of Cellectar Biosciences for the first 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 March 31, 2017 which can be found both on the SEC website at www.sec.gov 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. Additionally, 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. 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?

Jim Caruso

Analyst

Thank you, Jules and thank you to all participants for joining our first quarter 2017 financial and corporate performance review. We have started 2017 with a number of achievements, which we believe provide a strong foundation for the reminder of the year. While we have successfully executed against our stated objectives and guidance over Q1, there remains significant work to complete and progress to be made. That work continues to be focused on the advancement of our therapeutic phospholipid drug conjugate for PDC assets, specifically our lead product candidate CLR 131 as well as our CLR CTX chemotherapeutic conjugate program. At this time, I would like to share the milestones we have achieved over the quarter with regard to advancing CLR 131 as well as the strengthening of our overall intellectual property portfolio. From a clinical perspective, after successfully completing Cohort 3, we advance CLR 131 into a fourth cohort of our Phase 1 clinical trial in relapse refractory multiple myeloma. We continue to see consistently impressive safety results and positive indications of efficacy, including the most significant clinical outcome overall survival. In fact, I am pleased to report that Cohort 1 evaluable patients have now achieved median overall survival of 19.3 months and the survival benefit continues to increase for these patients as well as all evaluable patients enrolled in our Phase 1 trial. Our newly appointed Chief Medical Officer, Dr. John Friend will provide further color later in this call. In addition, we initiated our Phase 2 trial of CLR 131 in multiple myeloma and other hematologic malignancies, a full quarter ahead of schedule, which as you may know is supported by a $2 million National Cancer Institute Fast-Track contract. In addition, we announced two peer-reviewed studies, one publication in Nature Reviews Clinical Oncology and then oral presentation…

Chad Kolean

Analyst

Thank you, Jim. I will begin by identifying two aspects regarding our capitalization that occurred during the quarter after which I will provide a high level overview of our financial results. During the first quarter of 2017, we made substantial progress in improving the company’s financial position. As of December 31, 2016, we had 17 preferred Series A shares outstanding. As you may recall, these shares were issued for the financing that we completed on November 29, 2016 and were each convertible into 66,667 shares of common stock, more total of 1,133,339 common shares at the request of whole. During January 2017, all of these preferred Series A shares were converted into common stock and there are no additional shares of preferred stock outstanding. Another aspect of the November 2016 financing was the issuance of Series C warrants to purchase common stock at $1.50 per share. Since the beginning of 2017, holders have chosen to exercise 1,960,506 of these warrants resulting in the generation of an incremental $2.941 million in funding. These exercises occurred primarily during February and March with a nominal amount occurring in April. This has improved our cash reserves and extended our runway. Previously, we reported that we had funding into the first quarter of 2018, with the cash generated by the warrant exercises we now have funding into the second quarter of 2018. This also means that the November 2016 offering which was initially reported to have generated $9.2 million gross and approximately $8.3 million net has now generated approximately $12.1 million gross and $11.2 million in net funding proceeds received by the company. Now for an overview of our operating results from the first quarter of 2017, research and development expenses were $1.9 million, an increase of $0.8 million from the prior year. The increase…

Jim Caruso

Analyst

Thank you, Chad. As you know, we are now in the fourth Cohort of our Phase 1 clinical trial of CLR 131 and have initiated our NCI supported Phase 2 trial as well. John Friend will now provide us with an update on those clinical programs.

John Friend

Analyst

Thank you, Jim and good afternoon everyone. As you know, multiple myeloma is an incurable malignancy of plasma cells, which is part of the B-cell lineage of immune cells and an important component of our immune system. As a rare cancer, approximately 30,000 Americans will be diagnosed with mild myeloma and 12,500 deaths will be attributable to this disease in 2017. This hematologic cancer is characterized by both diffuse distribution and radio sensitivity suggesting systemically delivered targeted radio therapeutics such as CLR 131 may have a role in the treatment of this formidable disease. In spite of continued advances and expansion of treatment options or combinations of therapies for multiple myeloma, this disease remains an area of high unmet medical need without a cure on the horizon, the natural course of the disease results in nearly all patients experiencing multiple rounds of relapse or the development of disease which is resistant or refractory to treatments. Frequently the time to progression accelerates after each successive round of therapy. The greatest need continues to be the development of therapies that can improve overall survival while maintaining quality of life of each patient during their cancer journey. Given this current treatment paradigm and based on the clinical data already observed with a single infusion of CLR 131 in heavily pre-treated relapse refractory patient population, we remain optimistic regarding potential benefits of CLR 131 made provide to patients with this relapse refractory multiple myeloma and other B-cell cancers. As Jim stated earlier, I would like to provide you with a review of the top line data from Cohort 3 of our ongoing Phase 1 study. As a reminder the current Phase 1 study is an open label dose escalation study in relapsed or refractory multiple myeloma patients. The primary objective of this study is…

Jim Caruso

Analyst

Thank you for that thorough overview of our progress with CLR 131. As we regularly state, our focus remains on the successful execution of a clinical development of CLR 131 for the treatment of relapsed refractory multiple myeloma and other select hematologic malignancies and we are very pleased with our continued momentum towards that end and we do look forward to sharing future updates. At this time, I would like to turn the call over to Jarrod Longcor, Cellectar’s Senior Vice President of Corporate Development and Operations to discuss our preclinical programs in solid tumors as well as to provide an update on our collaboration with Pierre Fabre.

Jarrod Longcor

Analyst

Thank you, Jim. Our preclinical activities continued to accelerate and produced very encouraging results. With regard to CLR 131, we have focused our research to identify optimal dosing and regime tumor types as well as ideal drugs to be used in combination with CLR 131. We continue to strengthen our research capacity to leverage our CLR CTX conjugate programs, including the accelerating of the Pierre Fabre collaboration as well as our own in-house proprietary small molecule research. As Dr. Friend alluded to, we have been evaluating CLR 131 in multiple tumor models, including additional hematologic malignancies and solid tumors. These studies have involved examining the timing and number of additional doses in order to maximize efficacy as well as evaluating CLR 131 in combination with additional other treatments. As reported earlier this quarter, we have shown in several solid tumor models that additional doses of CLR 131 can have a significant effect on reducing the tumor volume or tumor burden and extending overall survival. Specifically, Capan-1 xenograft model of human pancreatic adenocarcinoma, CLR 131 has demonstrated that mice receiving two individual doses of 50 microcurie on Day 0 and Day 42 experienced mean survival of 135.6 days versus 64.6 days for mice receiving only a single dose of 50 microcurie on day zero. The second dose provided double the survival benefit in this challenging disease model and it is possible that additional doses could further enhance these outcomes. As this study and others that we are performing link directly to our ongoing Phase 2 clinical trial and the future development of CLR 131 we expect to provide further updates as appropriate. We believe CLR 131’s novel mechanism of action reduced dose frequency and predictable and manageable adverse event profile may make the compound an excellent drug for use in combination…

Jim Caruso

Analyst

Thank you, Jarrod. The overall progress of our preclinical program, including the demonstration of a doubling of survival benefits provided by a multi-dose regimen of CLR 131, advancement of the Pierre Fabre novel conjugate research and infrastructure development to accelerate future work is extremely promising. I believe it is also clear that we remain optimistic regarding the promise of CLR 131 for relapsed refractory multiple myeloma. The survival benefit of greater than 19 months in Cohort 1 is impressive and we look forward to further exploring the multi-dose clinical benefits of CLR 131 in multiple myeloma as well as other tumor types in our Phase 2 trial. In addition, the 5 patents granted year-to-date further demonstrates our effective performance in strengthening our intellectual property portfolio to better protect our assets and enhance their valuation. As always, we look forward to announcing additional company milestones and events as they occur. In conclusion, I would 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

Operator

Thank you, sir. [Operator Instructions] Our first question will come from the line of Wangzhi Li with Ladenburg Thalmann. Please proceed.

Wangzhi Li

Analyst

Hey, good afternoon. Thanks for answering my question in the conclusion on the progress of the quarter. So, just for a question for the Cohort 3 and also Cohort 1 carry a product update on the overall level, I mean 19.3 months is a quite good result. Could you maybe add some additional color in terms of the context not to compare to the other agents in-house this overall survival data looks like?

Jim Caruso

Analyst

Terrific. First of all, thank you, Wangzhi for the question and obviously also for participating in our call. We are very excited about what we are observing with CLR 131 both from a safety perspective as well as some of these indicators or surrogate markers of efficacy and in particular the most significant of all and that’s overall survival. With that, I will turn it over to John for his comments.

John Friend

Analyst

Great. Thanks, Wangzhi. So you are asking comparing on-market products to our own data. So, of course it’s very challenging to make any sort of direct comparison between what we are seeing in our Phase 1 study and also what other sponsors have seen to-date as you are well aware overall survival has been extremely difficult for current therapies to make a really truly meaningful impact on OS. As Jim mentioned, 19.3 months is pretty significant especially after just a single dose at the 12.5 millicurie per meter squared. Of course, keeping in mind this is a small sample size and compared to other trials which may have a little bit larger sample size, we have to keep that in mind. Now as we mentioned all of these patients are still alive. So, we are still monitoring these patients. So, this number will continue to see those numbers increase over time. Patients are normally seen every 2 to 3 months. So we see waves of data coming in which as you know that’s why the median overall survival Cohort 2 at 9.9 months and Cohort 3 are a little bit behind just from a lag and when these patients were enrolled. So, we will see continued data update for the foreseeable future. But yes, we are very encouraged by it, but it is difficult to make direct head-to-head comparisons, let’s say, against dara or other therapeutics.

Jim Caruso

Analyst

Yes. I think that’s some great comments John and I appreciate those and Wangzhi, John is correct, it’s difficult to compare apples-to-oranges with various studies, but I think it’s also informative to understand that historically in this space, we typically see overall survival of approximately 12 months and recently daratumumab really cracked the code with an overall survival of approximately 18 months. And so Dr. Friend is exactly correct. It’s always difficult to compare and contrast, especially when you take into consideration study and study design, et cetera. But I think it’s also clear to say that the single dose 12.5 millicurie performance we have seen north of 19 months early on is very, very encouraging and we look forward to seeing the performance with overall survival certainly in Cohort 2 and 3 as well which appear to be progressing along the same trend line.

Wangzhi Li

Analyst

Yes. Actually, my second question is what I mean I know it’s early and it’s hard to predict by, Brian, what’s your expectation for Cohort 3, because you mentioned the patients they are older, they are in worst condition to start with higher tumor burden and so far it looks that progression free survival is shorter than Cohort 1 and 2. So, what’s your expectation outlook for the overall survival, I mean, compared to Cohort 1, 2 or Cohort 3?

Jim Caruso

Analyst

Wangzhi, that’s a great question. It’s a $1 million question maybe or more. It’s really hard to predict right. So, you called it these patients are on a different curb just because of the risk for progression and also being an older with a significantly more tumor burden. So, I guess, Alfred [ph] out there is a medical person to say time will tell. I can’t be more – it would just be a pure guess at this point in time.

Wangzhi Li

Analyst

Yes, fair enough. So, I also made the last question for the preclinical side, Jarrod you mentioned, you are exploring some combination studies, could you give us any additional color in terms of what kind of agents, chemotherapy, PD1 or anything any color on that?

Jarrod Longcor

Analyst

Sure. I will give you only a limited amount of color obviously at this juncture for various reasons. But let it be said that essentially we are looking at combination treatments with some on-market drugs that are traditionally prescribed in a multiple myeloma setting. There is significant rationale for the ones we have selected so far to evaluate and that is why we are looking at those. With regard to the immunooncology, I will defer from responding to that directly other than to say, yes, they are immunooncology agents, some of them already known and some of them novel.

Jim Caruso

Analyst

The only thing I would add to that, Wangzhi is as we continue to move forward with multiple myeloma as a single agent potentially and more likely dose and frequency of multiple doses, we will also take into consideration a more traditional approach to expanding beyond the relapsed refractory setting in that third, fourth or fifth line and moving further upstream into treatment paradigm in combination with other compounds. And we believe because of the very unique and novel mechanism of action that CLR 131 has potentially 1, 2 or a 3 dose sequence as we further dial-in on dose and frequency and that plays out. Along with the adverse event profile, we believe this compound maybe particularly suited to be used in combination with the classes of medications that Jarrod just mentioned.

Wangzhi Li

Analyst

Got it. And just I mean, for the clarity by the – when you say combination, my guess is actually if you consider you are not – your inclusion with the other drugs at the same time or is it missed out?

Jarrod Longcor

Analyst

Yes, they are somewhat sequential. We can look at both as Jim was alluding to there, when you think about the dosing frequency, there is the option – opportunity to be able to dose essentially 131 dose the combination treatment, the other treatment and then come back in with an additional dose or two of 131. So obviously, that’s one scenario. The other one is you dose with a single infusion of 131 and then you do sequential just the follow-on dosing of the other agents. So either way, it can work.

Wangzhi Li

Analyst

Okay. Alright, great. Thank you very much for answering my questions.

Jim Caruso

Analyst

Terrific. Our pleasure, Wangzhi.

Operator

Operator

Thank you. I am showing no further questions. So, now it’s my pleasure to hand the conference back over to Mr. Jim Caruso, Chief Executive Office for closing comments and remarks. Sir?

Jim Caruso

Analyst

Terrific. Thank you and thank you for your support today on the conference call. We appreciate your interest in the company and we look forward to providing future updates. Thank you.

Operator

Operator

Ladies and gentlemen, thank you for your participation on today’s conference. This does conclude the program and you may all disconnect. Everybody have a wonderful day.