Allos Therapeutics, Inc Q4 2007 Earnings Call Transcript

Allos Therapeutics, Inc (ALTH)

Q4 2007 Earnings Call

February 27, 2008 8:30 am ET

Executives

Paul Berns - President and CEO

Dr. Pablo Cagnoni - Chief Medical Officer

Jim Caruso - Chief Commercial Officer

David Clark - Vice President of Finance

Analysts

Mark Monane – Needham & Company

Charles Duncan – JMP Securities

Jason Kantor – RBC Capital Markets

Presentation

Operator

Welcome to the Allos Therapeutics 2007 results conference call. During (Operator Instructions). This conference is being recorded today, Wednesday, February 27, 2008. I would now like to turn the conference over to Derek Cole. Please go ahead, sir.

Derek Cole

Good morning and thank you for joining us on today’s call. With me this morning are Paul Berns, President and CEO; Dr. Pablo Cagnoni, Chief Medical Officer; Jim Caruso, Chief Commercial Officer; and David Clark, Vice President of Finance.

Following this introduction, Paul will review the company’s 2007 and recent corporate highlights; Pablo will then provide an update on the company’s product development program; Jim will provide a brief commercial planning update; and David will review the company’s financial results for 2007. Paul will conclude with a review of our key 2008 objectives. We welcome your questions following Paul’s remarks.

As a reminder, this conference call is being recorded and webcast. The call may be accessed live on our website and will be available in our event archives for the next several weeks.

Before we begin, please be advised that during the course of this call we may make forward-looking statements concerning our company that are not historical facts. These forward-looking statements may include, but are not limited to, statements concerning our future financial performance, our future product development plan, timelines relating to our clinical trials, timelines for regulatory actions, and the potential safety and efficacy of our product candidates. Such forward-looking statements are not guarantees of future performance and are subject to risks and uncertainties that may cause actual results to differ materially from those anticipated by the forward-looking statements. Additional information concerning these risks and uncertainties contained in the risk factors section of the company’s quarterly report on Form 10-Q for the quarter ended September 30, 2007 and in the company’s other periodic reports and filings with the Securities and Exchange Commission.

The company cautions investors not to place undue reliance on these forward-looking statements. All forward-looking statements are based on information currently available to the company on the date hereof, and the company undertakes no obligation to revise or update these forward-looking statements to reflect events or circumstances after the date hereof, except as required by law.

I will now turn the call over to Paul.

Paul L. Berns

Thank you, Derek, and good morning to all. It’s a pleasure to update you this morning on the events of the past year and share our outlook for 2008, which we believe will be an important year for Allos.

Throughout 2007 we achieved key corporate objectives resulting in a strategic expansion of our PDX clinical development program, the implementation of a commercial planning effort for PDX in peripheral T-cell lymphoma and the advancement of RH1 to a new Phase I solid tumor program.

Under Dr. Pablo Cagnoni’s leadership our development organization is effectively executing the pivotal Phase II PROPEL trial of PDX in patients with PTCL and has driven the initiation of new studies and indications where we believe PDX has the potential to provide clinical benefit.

The commercial organization led by Jim Caruso has expanded our commercial planning and preparation for the future potential launch of PDX should PROPEL produce positive results and we receive marketing authorization from the FDA.

Now additionally, we closed an underwritten offering of 9 million shares of common stock in February 2007, resulting in an aggregate net proceed of approximately $50.3 million and strengthened the company’s leadership team through the addition of experienced industry veterans to our senior management and board of directors. We believe, we have established a product development and commercialization plan to effectively realize the therapeutic potential of PDX across multiple indications.

Let me now turn the call over to Pablo to provide more details on our clinical development programs.

Dr. Pablo J. Cagnoni

Thank you, Paul, and good morning. Allow me to begin by highlighting recent progress with PROPEL, our pivotal Phase II trial of PDX with concurrent vitamin B12 and folic acid supplementation in patients with relapsed or refractory peripheral T-cell lymphoma, or PTCL.

In December we were pleased to announce that an independent data monitoring committee completed a pre-planned interim analysis of safety data from the first 65 evaluable patients and recommended that the trial continued for the protocol.

In addition, in September of last year we were pleased to report that the result of a pre-planned interim analysis of patient response data exceeded the pre-specified threshold for continuation of the trial, which required a minimum of four responses, either complete or partial, out of the first 35 evaluable patients as determined by the independent oncology review.

We currently expect to complete patient enrollment in the second quarter of 2008 to report topline results by year end. Importantly, the PROPEL trial is being conducted under an agreement reached with the US Food and Drug Administration under its special protocol assessment or SPA process. This process allows for the FDA evaluation of the protocol intended to form the primary basis of an efficacy claim and support of a new drug application as SPA process provides an agreement that the study design including sample size, clinical end points and/or data analysis are acceptable to the FDA.

In addition to the PROPEL trial, we are also evaluating PDX potential clinical utility in other hematologic malignancies and solid tumors. In 2007, we initiated two additional studies in hematologic malignancies. A Phase I/2a, open-label, multi-center study of PDX and gemcitabine with vitamin B12 and folic acid supplementation in patients with relapsed or refractory non-Hodgkin’s lymphoma or Hodgkin’s disease and a Phase I open-label, multi-center study of PDX with vitamin B12 and folic acid supplementation in patients with relapsed or refractory cutaneous T-cell lymphoma.

We area also using our ongoing Phase I/2, open-label, single-center study of PDX in patients with relapsed or refractory non-Hodgkin’s Lymphoma or Hodgkin’s disease to explore dosing and administration schedules for PDX in patients with B-cell lymphoma.

We expect these programs to provide further insight into the clinical and commercial potential of PDX in hematologic malignancies and look forward to providing updates on these programs later this year.

During 2007, we also announced the presentation of data from our ongoing Phase I dose ranging study of PDX with vitamin B12 and folic acid supplementation in patients with previously treated advanced non-small cell lung cancer, at a 2007 AACR-NCI-EORTC conference. This non-small cell lung cancer data together with inputs from key opinion leadership and clinical investigators have helped to guide the development of PDX into solid tumors.

In January of this year, we initiated Phase IIB randomized multi-center study comparing PDX and Tarceva in patients with Stage IIIB and IV non-small cell lung cancer who are or have been cigarette smokers and who have failed treatment with at least one prior platinum-based chemotherapy regimen. The objective of the study is to compare the efficacy of PDX to that of Tarceva in this patient population. The primary end point of the study is overall survival and secondary end points includes response rate and progression-free survival both compared with Tarceva and we will evaluate the safety and tolerability of PDX as well.

The study will seek to enroll approximately 160 patients in upto 50 investigated sites worldwide. We believe the study will provide important data on the potential utility of PDX in a patient population that is not adequately served by current approved treatments.

We continue to be encouraged by the progress of our PDX development program. Based on PDX’s rationale design for improved uptake and retention in malignant cells, we believe PDX has potential across multiple indications in both hematologic malignancies and solid tumors.

To conclude our clinical development update, RH1 is a novel small molecule chemotherapeutic agent that we intend to evaluate for oncology use as a single agent and in combination with other therapies. In November, we initiated patient enrollment in a Phase I open-label, multi-center dose-escalation study of RH1 in patients with advanced solid tumors or non-Hodgkin’s lymphoma. We’ve planned to enroll up to 60 evaluable patients in this study with the objective of determining the maximum tolerated dose, recommended Phase 2 dose and safety profile of RH1 in this patient population.

With that, I will now turn the call over to Jim.

James V. Caruso

Thank you, Pablo. We continue to be focused on detailed product development and commercialization planning and execution for the potential commercialization of PDX. Over the past year we have expanded our efforts to ensure clinician understanding of PDX and its potential implications for T-cell disease management. We have gained new insights into perceptions of available treatment options that will help guide brand position. Feedback received from patients, patient advocacy groups and clinicians continue to underscore the urgent need for new therapies to treat patients with aggressive T-cell lymphoma.

As was discussed most recently by presenters and participants at the International Congress on Hematologic Malignancies, outcomes associated with existing therapies prescribed in this setting are disappointing leading clinicians in search of new and viable alternatives to treat these challenging diseases.

Based on PDX’s unique mechanism of action, along with the clinical experience to-date, we believe PDX has the potential to play a clinically meaningful role in the treatment of T-cell lymphoma patients.

Based on management’s experience commercializing specialty pharmaceutical products, coupled with dynamics of the US marketplace, we look forward to the promotion of PDX in the United States, if approved for marketing.

In 2007, we received orphan medicinal product designation for PDX for the treatment of patients with PTCL from the Commission of the European Communities with a favorable opinion from the Committee for Orphan Medicinal Products of the European Medicines Agency. The designation complements the orphan drug and fast track designations previously granted by the FDA to PDX for the treatment of patients with T-cell lymphoma.

Outside the US, we will continue to consider strategic partnership opportunities that we believe are in the best interest of our company, customers, and shareholders. Importantly, Allos retains exclusive worldwide rights to PDX for all indications.

With that overview, I will now turn the call over to David Clark for our financial review.

David C. Clark

Thanks, Jim. For the year ended December 31, 2007, we reported a net loss of $39.4million or $0.60 per share. This compares to a net loss of $30.2 million or $0.55 per share for 2006.

Our cash position at the end of 2007 was $57.8 million. Our cash used in operations for 2007 was $30.8 million. We expect that our cash used in operations for 2008 will be in the range of $42 to $46 million. This projected increase is primarily due to investments in our ongoing and planned clinical trials involving PDX, clinical manufacturing cost of PDX for clinical trial material and pre-commercial scale-up activities and investments relating to commercial planning activities for PDX.

So based upon our product development plans, we believe that our current cash position is sufficient to fund operations through at least the first quarter of 2009.

Now I will turn the call back to Paul.

Paul L. Berns

Thank you, David. As I’m sure you can appreciate, we are pleased with our progress in 2007 and look forward to several important near-term milestones.

Now for 2008, we are focused on driving on our PDX product development and commercialization plan with the clear focus on completing PROPEL. As Pablo indicated, we intend to complete enrollment in PROPEL in the second quarter of 2008 and report topline results by year end. If the results are positive, we intend to seek regulatory approval to market PDX for the treatment of patients with relapsed or refractory PTCL.

In addition to the PROPEL trial, we are committed to evaluating PDX for oncology use as a single agent and in combination with other therapies. We currently have six ongoing clinical trials involving PDX, including the PROPEL trial evaluating the compound's potential clinical utility in hematologic malignancies and solid tumor indications. We intend to initiate a Phase II, single agent study of PDX in another solid tumor indication in the first half of 2008 and additional Phase 1 combination studies in solid tumor indications by year end. We believe 2008 has the potential to be an exciting year for Allos. We look-forward to keeping you apprised of our progress.

And now, we would like to turn the call over to the operator for your questions. Operator?

Question-and-Answer Session

Operator

(Operator Instructions). Our first question comes from the line of Mark Monane with Needham & Company. Please go ahead.

Mark Monane – Needham & Company

Good morning and thank you for taking my questions. Regards from New York City.

Paul Berns

Hi Mark.

Mark Monane – Needham & Company

A couple of questions. First, let’s start with a more concrete one. In the six trials, could you update us a little bit about the NHL trial that's ongoing now, I believe, with gemcitabine and as well, could you talk about the NHL trial that is ongoing, I guess, in B-cell versus T-cell lymphoma?

Paul Berns

Sure Mark. I will have Pablo speak to that.

Pablo Cagnoni

Good morning, Mark. The trial in combination with gemcitabine is a Phase I study and we are trying refine the dose and schedule for these two agents in combination. All I can say at this point is going well. We've had a lot of interest from sites in participating and we are moving aggressively to try to find the right dose and schedule approach range and combination.

The only thing I want to say in terms of efficacy, we’ve seen some interesting results in some very heavily pre-treated patients including B-cell lymphoma patients even though it’s a Phase I study this means some very interesting evidence of activity. In terms of the Phase I /2b cell trial that’s been conducted a single institution that’s Columbia and the Principal Investigator is Owen O’Connor, and what we are doing in that study is testing the higher dose and the every other week schedule that we are using in solid tumors in patients with B-cell lymphoma and Hodgkin’s disease. So far we have five patients or so enrolled, it’s going well. There has been some early evidence that this dose might be more effective in this population that under lower dose, but that’s how we can say at this point.

Paul Berns

Mark, we are very pleased. Thank you, Pablo. We are very pleased with the activities – early activities we have seen to-date. To the Pablo’s point, the investigators are driving the recruitment of the studies and have a great level of interest in evaluating the potential clinical utility of PDX and the B-cell setting. And, as we mentioned in our prior comments, we do look forward to providing an update later in the year on those programs. I think it will be an exciting opportunity for us.

Mark Monane – Needham & Company

That’s helpful. Moving up on Alimta and thinking by Alimta and PDX in lung cancer. If Alimta moves into the first line indication, maybe you can comment on what you think the role of PDX might be going forward, and do we have any data on PDX utility in patients who have KRAS mutation, which we know don’t respond very well to EGFR inhibitors?

Pablo Cagnoni

Okay. So the first part of the question is regarding Alimta. We do not have clinical data at this point about how well PDX works in patients that failed Alimta. This did have a very different mechanism of action. As you know, if the reason for a patient to fail Alimta is related to over-expression of TS, PDX will work fine in that population. Even if Alimta successfully penetrates the first line marketing in non-small lung cancer, historically no single regimen has dominated more than 35% to 40% of the marked dose until the plenty of patients that received something other than Alimta in first line. So we are not too concerned about that at this point.

Second part of the question, KRAS, we have no data. There is no reason to believe that PDX will not work in patients with a KRAS mutation. As you know, that’s one of the reasons probably why EGFR-TKIs don’t work very well and smokers have the higher instance of KRAS mutations in those patients, but we have no data related to that with PDX.

James Caruso

When you look at that one space, it’s going to look very differently over the next three or four years in particular. And if in fact Alimta and though we are successful in terms of moving Alimta into more of a first line setting there, with the advent of both Gemzar and Taxotere moving off patent into very near future would essentially leave Tarceva as one of the sole therapies in the second line setting there. So we believe – so the net of it is that we believe we have a very good strategic opportunity to move PDX into the second line setting downstream as a potential registration strategy.

Mark Monane – Needham & Company

When you are talking to doctors who are doing the market research on the T-cell lymphoma space, how many doctors are there really that are involved in this space and, therefore, what do you think given your marketing background might be the optimal size of the sales force that might address this population?

Paul Berns

It’s a great question Mark, and we have done some preliminary sales force optimization, essentially segmenting the space as you had just mentioned and you decile the clinicians based on the estimated volume per clinician to establish a workload capacity that require to effectively establish the right degree of reach and frequency to optimize the level of investment in terms of what medical education and sales force deployment.

We still believe and maintain that there are a handful of the top deciles that drive a significant amount of the overall business, not only in NHL, but in particular PTCL. I have actually stated in the past, we have these catchment centers, what is academic institutions where some real experts in terms of the treatment of peripheral T-cell lymphoma live and whether it’s in a refractory setting second, third line or further downstream, these patients historically at the end of the day are referred to these catchment centers and we believe this makes our space in the PTCL area in particular highly scalable. So the right level of judicious investment should equate to a very high rate of return.

Operator

Thank you. Our next question comes from the line of Charles Duncan with JMP Securities. Please go ahead.

Charles Duncan – JMP Securities

Hey guys, thanks for taking the call. I had a quick question regarding pralatrexate progress in PTCL trial. Can you run through kind of what your assumptions are with regard to top line data at the end of the year specifically with regard to the number of cycles that you may be interested in providing a top line observation on and what are some of the other criteria that you are looking at for releasing that data?

Paul Berns

Sure. Charles, this is Paul. Thank you for joining us this morning. I will turn it over to Pablo, but quickly just to confirm we do intend releasing top line data from the PROPEL trial at year-end. Some of the investigators are highly motivated to do so as well in the key period of the Medical Conference. And with that, I will turn it over to Pablo to speak to more specifics.

Pablo Cagnoni

Good morning Charles. The plan at this point, as you heard earlier, is to complete accrual that’s got into the second quarter of this year and we intend to submit it to ASH and basically we were going to present this data with assessment of three sectors of therapy in all the patients -- in all the evaluable patients enrolled in this study.

Charles Duncan – JMP Securities

So at ASH, you will provide update on all evaluable patients. Can you tell us approximately how many are evaluable at this point?

Pablo Cagnoni

No. I do, as you probably may recall, the plan for the PROPEL study is to enroll a minimum of 100 evaluable patients.

Paul Berns

That’s right. And Charles, the reason for that is that we have independent reviewers not just looking at data as you are aware, but obviously there is an independent reviewer for histology. This is a extremely well-run study in the context of supporting and executing the SPA from protocol from the FDA. It’s a matter of processing accordingly with the independent reviewers even with the histology component as well as it relates to then those patients that are counted as evaluable, if you will. We are very pleased though frankly with the conduct of the trial in terms of the efforts and recruitment efforts with the clinicians.

Charles Duncan – JMP Securities

So it sounds like enrollment could go beyond the 100 patients if histology or some other criteria kind of holds it up or if demand for participation is high, can you give us some thoughts on that?

Pablo Cagnoni

Well, I can tell you that that assumption is correct. If there is evaluable patients due to histology then we’ll have to exceed that 100 total sample size. Again, the goal is to have 100 evaluable patients. Evaluable patient to fund the protocol is patients that have confirmation of histology by an independent reviewer and receive at least one dose of study drug, so we need a minimum of 100 of those.

Charles Duncan – JMP Securities

Okay. And do you anticipate announcing when you hit that 100 mark?

Pablo Cagnoni

The only announcement we are going to put out is when we complete enrollment and we will complete enrollment when we are satisfied that we have a minimum of 100 evaluable patients.

Charles Duncan – JMP Securities

Okay. And then may I ask a question regarding the guidance in terms of the 42 or so million dollars spend this year. Can you give us some insight as to roughly the amount that you intend to spend on pre-commercialization activities for pralatrexate?

Paul Berns

What I can say Charles is that our guidance does include certain investments relating to the potential commercialization of PDX including manufacturing cost of PDX relating to pre-commercial scale of activities and we are also making what I would call judicious investments relating to commercial planning activities. What I can say is that results from the PROPEL trial are positive, we would expect that our operating expenses and cash used going forward will increase in order to prepare for the potential commercialization of PDX.

Charles Duncan – JMP Securities

Okay, that makes sense. Thanks for the added color.

Paul Berns

Thank you, Charles.

Operator

Thank you. Our next question comes from the line of Jason Kantor with RBC Capital Markets. Please go ahead.

Jason Kantor – RBC Capital Markets

Thanks for taking my call. So very interesting trial in lung cancer that you guys set up and I’m just wondering if you can give us some understanding of how you estimated your survival for the PDX ARM and how you think about the powering of the study, can you actually show an improvement in survival in this population? And then also is this the smoker population, we clearly know that that’s an important subgroup when it comes to Tarceva, but is this actually going to be an improvable subgroup, have you talked to the FDA about this as a specific indication?

Pablo Cagnoni

Yes, let me start with the second half of the question first. Yes, we’ve discussed the investigative plan with the FDA for the Phase II and for potential Phase III study in this particular subset of non-small cell lung cancer patients and we have agreement over not just SPA or anything related to that, but we have a very productive discussion with the agency and they are agreed with the subpopulation that we are going to target in the study. So that’s pretty clear to us at this point. And (indiscernible) power, this is a Phase II study. So power in the usual sense of using the Phase III study is really not relevant. We are going to estimate the treatment effect and once we are done with the study, which is pretty large randomized Phase II with 160 patients, we will look at the treatment effect and based on that we will design a Phase III trial that is adequately powered to detect a meaningful difference in survival between the two ARMS.

Jason Kantor – RBC Capital Markets

And another question on the finance side. You say that your current cash position is good through the first quarter of ’09; clearly, you don’t want to run that too low. How confident are you that you can do some sort of lucrative partnership, or would you want to before PROPEL data, or do you need to raise money in the capital market?

David Clark

So, Jason, its David. I think, to your point we do have a business plan that our current cash position will be adequate to fund our operations through Q1 of 2009. With that said we do have an active shelf on file with the SEC, and as always we expect to be opportunistic in obtaining additional capital to continue to fund our plans for both product development, and for the potential commercialization of PDX. So as always we’re going to be optimistic.

Paul Berns

I think also, Jason, just to follow up -- thank you, David, but follow up on your partnering component of that question, our corporate strategy has and continues to be that we are evaluating, we have certain interest and discussions with parties that have been ongoing, and I would suspect it will continue to be as we evaluate the potential utility of partnering on an ex-US basis for the development and commercialization of PDX, if you will. As you can imagine, the bar is very, very high there in the context of on evaluating that type of structure and value creation in the best interest of our company and our shareholders.

To that end, given the business plan that we have laid out and guidance David spoke to today with regards to managing our cash and our investments, we feel very comfortable with regards to completing PROPEL, getting the top line data, managing our investments and cash to the best interest of our shareholders and putting us in a position with what we hope to be will be compelling data, coming out of PROPEL that gives us a much better negotiating position. So certain another way, we’re not rushing at all in the context of having to establish a partnership, but we’re certainly evaluating those opportunities.

Jason Kantor – RBC Capital Markets

Thank you.

Paul Berns

Yeah, thanks for the questions.

Operator

Thank you. Our next question comes from the line of Rahul Jasuja. Please go ahead.

Rahul Jasuja

Morning, guys. Couple of questions. One of them really pertains to the mechanistic difference that we’re looking at with PDX, and maybe you’ve answered this before, but really is the difference in the mechanism targeting DFHR versus TS really what separates PDX from Alimta and methotrexate, for example, efficacy across with solid tumors and so on. And more importantly, how will that play out in the commercial setting?

And then a couple more questions, I’ll ask them right away and then take the answer offline. Pfizer is running on clinical trial, I think it’s Pfizer with tyrosine kinase inhibitor and I believe, it’s Alimta in solid tumors. Any prospects or thoughts about PDX with biological inhibitors and solid tumors? And then finally, something that I think Paul referred to in maybe a past conference call, PDX in RA as I acid folic, methotrexate have been using RA. Thanks, guys.

James Caruso

I’ll have Pablo speak to the first few questions there, and I’ll talk about the immunology potential.

Pablo Cagnoni

So the first part of the question was that mechanistic differences between Alimta and PDX. Alimta is primarily a TS inhibitor. PDX is exclusively DHFR inhibitor. We presented the ARTC conference last year, a cell 3 as a basically showing that PDX is a much more potent DHFR inhibitor, I think it is a pretty weak DHFR inhibitor compared with PDX. So I think that mechanistic difference is pretty clear. In terms of methotrexate, the mechanism of action is identical to PDX. The difference between the two compounds is that PDX is internalized a lot more effectively than methotrexate, and once internalized, it’s probably [glutamalated] more effectively than methotrexate leading to probably longer retention times inside a cell, and better invasion of the target. So those are the key mechanistic differences among these three agents. I don’t know whether Jim wants to comment about how is that going to play out commercially?

James Caruso

Whenever you can differentiate your mechanism of action from another competitor and provide rationale for utilization it’s a significant advantage. So, from a mechanism of action perspective and the manner in which we work in terms of not only our impact on DHFR relative to TS, but also the manner in which the ease of transport if you will, that PDX has relative to accessing the cell as well as the polyagglutination effect, it really allows it to bulk up and have additional efficacy as a result of the bulking within the cell. Additionally, PDX has also demonstrated the capacity, and Pablo can talk to you in greater detail, to be used in combination with some agents where Alimta has not demonstrated that capacity, which also may provide some additional strategic, both clinical and commercial advantages for downstream.

Paul Berns

I think, all in all, Rahul, what’s interesting for us, I think really we’ve done a good job of this and that is bringing a next generation and folate to the market Alimta is a very good drug, and it helps many, many patients will continue to do so. But it has really, I think with the trial and use in uptake in the clinical, commercial marketplace has clearly demonstrated the unmet (Ph) medical need that exists even with the advent of certain programs are going we’ve targeted therapies and other agents, and has continued to build great interest for the utility of potential next generation and folate PDX clearly falls within that classification, and we know to the comments we just made today and the research that we’re now putting out is that PDX and Alimta are even differentiated to each other, but it’s very good news for patients. And we have great interest from clinicians in that regard. We’re very fortunate that PDX looks to demonstrate activity in our view both in hematologic malignancies and solid tumors which we think will provide for very important clinical and commercial opportunities. And you know, we think that’s very, very important. As it relates to the expanded use of side of oncology and looking at immunology, or in chrome setting, it is very clear that methotrexate has had a very, very rich history in utility in the immunology setting, RA in particular, and it is an opportunity that we are evaluating, it’s in a very, very early stage, we’ve done some very early pre-clinical animal model work that looks very interesting from an activity perspective relative to methotrexate in those models. But here again it’s early, and as we stand today, we’re an oncology focused business, will continue to be focused on oncology, but in a separate parallel path we will in a very cost effective manner look to move forward to understand its potential utility in other areas. Pablo?

Pablo Cagnoni

I think last part of your question was combinations of PDX with other agents, biological targeted agents, et cetera, we don’t have immediate plans to conduct those trials, we’re actively considering the next set of trials that will be initiated with PDX and certainly commission of PDX with, I believe you were referring to submit antibody agents like that. We’ll be considering that in the near future.

Rahul Jasuja

Okay. Thanks. Great.

Paul Berns

Thank you, Rahul.

Operator

Thank you. There are no further questions in the queue. And I’ll turn it back over to Paul Berns for any closing remarks.

Paul Berns

Thank you, operator. To conclude this morning’s call, I would like to summarize our three key corporate operating principles:

First, our focus on excellence and innovation in the development and execution of our clinical programs.

Second, proactively evaluate opportunities to grow our business through potential product acquisition, partnerships and other strategic initiatives.

And third, lead with ethics and integrity to ensure quality business decisions that create value for our patients, employees and stockholders.

As always, we appreciate your participation and look forward to keeping you apprised of our progress in the months ahead. Have a good day.

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