SLS - NASDAQ

Remy Bernarda - SVP, Corporate Communications, IR Mark Schwartz - President and CEO Chris Lento - SVP of Commercial Gavin Choy - SVP, Clinical Sciences and Operations Ryan Dunlap - VP and CFO

Yigal Nochomovitz - Oppenheimer Mara Goldstein - Cantor Fitzgerald Joseph Pantginis - Roth Capital Partners Robert LeBoyer - Maxim Group Jason Kolbert - Maxim Group Rahul Jasuja - Noble Life Science

Good day, ladies and gentlemen, and welcome to the Galena Biopharma Incorporated Fourth Quarter and Year End 2014 Earnings Conference Call. [Operator Instructions] As a reminder, this conference call is being recorded. I would now like to introduce your host for today's conference, Ms. Remy Bernarda, Senior Vice President, Investor Relations and Corporate Communications. Ma'am, you may begin.

Good afternoon, everyone, and thank you for joining our call today. For those of you listening via telephone, I would encourage you to visit our website and log into our webcast presentation. For this year end call, we will be using slides to enhance our information flow. The slides can be accessed on our website in the Investors section under Events and Presentation. These slides are posted both as a PDF document and will also be available on the webcast. The slides are viewer controlled, meaning that you, the viewer will need to advance the slides. Our speakers will alert you to the slides they are addressing. As listed on slide number 2 on our presentation, during today's discussion, we may make forward-looking statements about our programs. Such statements include, but are not limited to, statements about our commercialization plans and the development progress of our clinical product candidates, including patient enrollment, trial initiations and collaborations. These forward-looking statements are subject to a number of risks, uncertainties and assumptions, including those identified under Risk Factors in our annual report on Form 10-K which we have filed today and other documents filed with the SEC and available on our website. Actual results may differ materially from those contemplated by these forward-looking statements. I would now like to introduce the members of management on the call. Dr. Mark Schwartz, our President and CEO; Dr. Gavin Choy, Senior Vice President, Clinical Sciences and Operations, who will discuss our Clinical Programs; Christopher Lento, Senior Vice President of Commercial, who will discuss our Commercial Business; and Ryan Dunlap, our Vice President and Chief Financial Officer. Please turn to slide number 3 for the overview of our pipelines. Dr. Schwartz will now begin our discussion.

Thank you, Remy. And welcome everyone to our fourth quarter and year end earnings conference call. Our team did a great job in 2014 and as it was great pleasure that we view our progress last year in preview our expectations for 2015. Today we will review these accomplishments and discuss key developments coming in 2015. Before I go into the details on our programs, I want to address the status of our corporate issues regarding the SEC we are aware that the SEC is investigating certain matters, relating to the use of certain outside Investor Relations professionals by us and by other public companies. We have been in contact with the SEC staffs for our council and are cooperating with the investigation. As we mentioned in our press release, the Plaintiffs in the Delaware derivative litigation have dropped their case against the company. As a reminder, Galena had formed a Special Litigation Committee or SLC to investigate the claims from this law suite and produce the report because the Delaware derivative litigation was dropped, the SLC is terminated its work. They are still two derivative cases pending in Oregon Federal and Oregon State Courts and we continue to pursue these vigorously. Although the litigation matters take time to resolve, the company is committed to bringing these maters to closure in a timely manner. So we cannot say with certainty, we believe we will be able to resolve the outstanding matters in a way that will not materially impact our cash position by the fundamentals of our business. Now on to our programs, please turn to Slide 4, as I will expand upon our my comments from last quarter about how our two businesses units commercial and clinical fit into our overall strategy. As I stated before, Galena's current structure, a development stage immunotherapy focused company, complemented by commercial franchise makes us unique. Our focus is on building Galena into a leading oncology company, to establish in our commercial franchise as the strategic components for the long term growth and sets a foundation for our future. Our commercial franchise gives us two of the most important elements to maximize the value of our development assets, flexibility and control. While we are in continuous dialogue with potential partners for our development assets, having our own commercial capabilities provides us with significant leverage to secure better economics, around future partnering deals, or if we choose, we can commercialize and promote our products ourselves or co-promote in the U.S. with a commercial partner. As Chris will elaborate the relationships our commercial team is making now with key oncology healthcare providers, distributors and managed care groups, are not only extremely valuable for selling our current products but also provide the ability to quickly add future products. And finally, we expect the commercial business to maximize revenues become accretive and provide money to the company to help fund our development assets and minimize shareholder dilution. I would like to make one note on our

Thank you, Mark. As Mark mentioned, our primary focus in clinical development is on our immunotherapy programs with NeuVax and GALE-301 with a summary shown on Slide 10. Both of our programs have similar approach utilizing a peptide vaccine in combination with immune adjuvant GM-CSF to prevent the recurrence of cancer. Patients have been treated with standard of care therapy, which includes surgery, chemotherapy, and radiation therapy. Once treated, these patients presumably have no evidence of disease but remain at a significant risk of recurrence due to possible micro metastatic disease. Our goal is to prevent this recurrence because once a patient recurs death will likely ensue, by preventing recurrence we can prevent death. One of the essential elements of our treatment approach is to target patients in the adjuvant setting or declared disease free. This patient population generally has healthy immune systems that have been reconstituted and are able to mount a robust response to immunotherapy treatment. Thus our agents work to stimulate the immune system to generate tumor targeting cytotoxic T emphasize or CTL to prevent the recurrence of cancer utilizing well validated targets such as HER2 and Folate binding protein. Patients treated with our agents undergo a primary vaccine series once in month for six month followed by twice yielded booster inoculations to provide a long term protective effect. While Mark discussed where NeuVax fits into the immunotherapy landscape, I want to share with you in greater detail our ongoing programs, as well as potential franchise expansion opportunities. NeuVax is a peptide vaccine derived from the HER2 protein. On Slide 11, I'll provide a brief overview of HER2 which is an oncogene in the EGFR family. Amplification or over expression of this oncogene has been sure to play an important role in the development and profession of breast cancer. While historically HER2 over expression was associated with four prognosis locations, it is now a primary treatment target for a number of marketers and investigational agents, because it is overexpressed in a variety of tumors including breast and gastric cancers. As you can see on the chart, HER2 is expressed at four different levels and only HER2 3+ patients have any approved treatment options. NeuVax is currently targeting patients in three of the four categories of HER2 expression with our clinical trials. First let me start with our most important study, our Phase III PRESENT trial, the trial design can be viewed on Slide 12. 95% of the women who are diagnosed for breast cancer will have a terrible form of the disease, while this is very good news for these women that prognosis is very poor if their disease recurs and becomes metastatic. The PRESENT trial is treating women diagnosed with no positive breast cancer, who express HER2 into low to intermediate range where the 1+ 2+ patients defined by immunohistochemistry or 2+ non-amplified by FISH. 2014 was a critical year for PRESENT as we enrolled the majority of our patient’s culminating with the dosing of our 700 patient last month. This was a critically important milestone as the 700 patient represents the enrollment target as defined by the study protocol. This study has been granted a special protocol assessment by the FDA certifying the agreement with the agency regarding the study endpoints, study design and statistical assumptions of the clinical trial. We're currently over enrolling the trial by 5% to 10%, given the number of patients already identified in the screening process. Over-enrollment increases our confidence in both the timing and the quality of the statistics and the final outcome of the trial. We expect to complete enrollment near the end of the first quarter. Once this is accomplished with the last patient enrolled, the clock will start on the primary endpoint of 141 events or three years from the last patient enrolled, whichever is longer. Once we reach full enrollment, the next critical milestone for PRESENT will be achieving a positive readout on our interim analysis. The interim analysis is both a safety analysis, as well a futility analysis. The timing of the interim analysis is based on 70 events defined as recurrence or death. Currently we anticipate reaching to interim analysis by the end of 2015 or early 2016. As PRESENT is evaluating NeuVax as a single agent, the NeuVax franchise also encompasses two additional trials in combination with Herceptin or trastuzumab. These trials not only expand the clinical utility of NeuVax with the ability to treat more women, but they also provide supportive safety and efficacy data in addition to the PRESENT trial. While NeuVax may demonstrate efficacy as the single agent, they may also work well in combination with trastuzumab. There are immune mediate mechanisms of action for trastuzumab that may provide the rationale for such an approach. Through its FC receptor, trastuzumab mediates antibody-dependent cellular cytotoxicity, which results into release of antigen and generation of a CTA positive T cell response via across presentation. In addition, there is data suggesting that trastuzumab releases an antigen specific CD4 T cell response also known as a helper T cell response as well as a HER2 specific antibody response. Together these agents promote a broader anti-HER2 immune response that could be augmented with vaccination. On Slide 13, you can see the trial design for our Phase II combination trial with trastuzumab. With 300 patients to be treated, this is a very robust clinical trial treating women who are node positive and high risk node negative and our HER2 1+ and 2+ expressers. We estimate completion of enrollment in this trial by end of this year or first quarter of 2016 with a primary endpoint of disease free survival at two years. Last year we also announced initiation of a second trial in combination with Herceptin and we're grateful to Dr. Beth Mittendorf, for securing partial funding for this trial from the department of defense. The trial scheme can be seen on Slide 14. Importantly this trial is targeting a new area for us treating breast cancer patients or a higher - who are the higher 3+ HER2 expressers. These patients are treated in a new adjuvant setting or before surgery and have failed to obtain a pathological complete response. I believe it’s also important to note that outside of the PRESENT trial, all of our other NeuVax trials are partially funded by grants or collaborations giving us the opportunity to expand our pipeline in a cost effective manner. I would now like to provide a brief overview on the opportunities for future development of NeuVax, so please turn to Slide 15. As depicted in this development priority Ischemia, our primary focus for NeuVax is currently with HER2 1+/ 2+ breast cancer in the PRESENT trial and HER2 1+/2+ and HER2 3+ breast cancers with our combination trials. Next year our partner Dr. Reddy's will initiate the gastric cancer trial in India targeting patient in the HER2 1+/2+ and 3+ setting. As Mark mentioned, checkpoint inhibitors have been groundbreaking for the immunotherapy space and potentially combining NeuVax in this area who wants further consideration and exploration. As you can see in the slide on the 2nd and 3rd priority levels to our numerous development opportunities for NeuVax and other tumor types expressing HER2, we're continually evaluating opportunities to expand NeuVax in appropriate therapeutic settings. We will continue to be diligent about the use of our resources and insure any future trials are the right fit for the compound and inform by pre-clinical work and published literature. Now let me provide a few remarks about our ongoing GALE-301 development. GALE-301 is a peptide vaccine that stimulates CTLs to recognize and destroy cancer cells that express Folate Binding Protein or FBP. FBP is overexpressed in more than 90% of ovarian and endometrial cancers. The level of expression has been found to be greater than 20 fold higher in malignant cells, compared to normal cells. FBP is also expressed in 20% to 50% of a wide range of epithelial cancers including breast cancer. Preventing the recurrence of cancer is notably meaningful in the ovarian and endometrial cancer patient population. Unfortunately, women suffering from endometrial and ovarian cancers have a recurrence rate much higher than breast cancer. As depicted on Slide 16, we can see some of the dire statistics around the disease including a five year survival rate of approximately 45% and over 14,000 deaths in 2014. Specifically GALE-301 is being evaluated in women with ovarian and endometrial cancers with stage one to stage four disease who have no evidence of disease after undergoing their primary first line therapy including debulking surgery and chemotherapy. Based on our positive Phase I data, the trial moved into the ongoing Phase IIa portion with the optimal dose of 1,000 micrograms and an added booster regimen in the same population. As we mentioned last quarter, we met our enrollment goal early and overenrolled with a total of 51 patients. We believe this enthusiasm is due to the lack of treatment options with these women responding heightened interest in the trial. At the society for the immunotherapy for a cancer conference last November, we presented very promising data from the Phase IIa portion of our trial, which is shown on Slide 17. The data demonstrated that GALE-301 was well tolerated and listed a strong and vivo immune response with primarily grade 1 and grade 2 toxicities. Importantly, the data show a 31% recurrence rate in the vaccine group, compared to 50% in the control group at a medium follow-up of 30 months. This is a 38% reduction and relative risk of recurrence. We expect topline data from the Phase IIa portion of a trial to be presented this summer. Moving to our hematology asset, GALE-401 is our controlled-release formulation of Anagrelide and development to reduce elevated platelet count in patients with thrombocythemia secondary to myeloproliferative neoplasms. During 2014, our team made exceptional progress with GALE-401. In a span of one year, we purchased the asset, initiated a clinical proof-of-concept Phase II trial, and rolled that trial ahead of schedule and presented the Phase I healthy volunteer studies and very early Phase II data at the American Society of Hematology Meeting in December. As you can see on Slide 18, the Phase I result show that in 98 healthy adult subjects, GALE-401 showed a tolerable safety profile and maintained a platelet lowering ability of the agent, while reducing the Cmax. The preliminary Phase II clinical trial data also showed promising platelet response. The Phase II trial is ongoing at eight active sites in the U.S. as we continue to treat and monitor the safety and efficacy of the patients enrolled. We expect topline readout of the data by mid-year or final results by year end. In closing, we have achieved several important milestone in 2014 across our development programs. I'm extremely grateful to our clinical team for their efforts and for the courage of the patients who volunteer for our trials. In 2015 we will have a number of key data presentations that will highlight divestment of our clinical programs. I'm excited for what the year holds and the potential of our development pipeline. I like now to handover the call to Chris Lento, to give our commercial programs.

Thank you, Gavin. Today we'll walk you through the 2014 successes we have had with our flagship product Abstral. I'll also take a moment to discuss the status of the launch of our second commercial product

Thank you, Chris and good afternoon everyone. Net revenue from Abstral sales for the fourth quarter of 2014 was $3.2 million and $9.3 million for the full year 2014. We are happy to say that Q4 was a record quarter for us reflecting a 100% increase from the $1.6 million net revenue reported in Q3 and landing us squarely within our 2014 net revenue guidance of $8 million to $10 million. We are certainly pleased with that trend and remain confident in our 2015 net revenue guidance of $15 million to $18 million with the expectation that our Abstral business will become cash flow positive by the end of 2015 and will continue to be the key revenue driver this year. Also with the launch of

Thank you, Ryan. As I stated in my opening remarks, our team significantly advanced all of our clinical and commercial programs in 2014. If you look at Slide 25, you can see that there are several fundamental milestones over the next year. For NeuVax our primary drivers will be completing enrollment our PRESENT trial next month and the preplanned interim analysis in late 2015, early 2016. We also expect to complete enrollment in the NeuVax and Herceptin combination trial during that same timeframe with key clinical milestones in 2016 and 2017. GALE-301 and GALE-401 will also update to read out this year. Finally as both Ryan and Chris mentioned, we expect to nearly double our revenues this year and look forward to launching our second commercial product this year. We expect to accumulate multiple value drivers as we head towards the final read out of the PRESENT trial. With achievement of these milestones across all of our programs, we expect to steadily build value for our shareholders. As I noted in my opening remarks, Galena is unique among similar sized biotechnology, immune-oncology companies and that we possess a very active development program combined with a rapidly growing commercial operations. This business strategy provides us with numerous opportunities to create value in both the short term and long-term, while positioning Galena to address multiple treatment needs across the full spectrum of cancer care. We will now open the call for questions.

[Operator Instructions] Our first question comes from Yigal Nochomovitz from Oppenheimer your line is open.

Hi, thanks very much for taking the questions. I just had a few on the commercial side of the business, I know you said that the $15 million to $18 million guidance range, can you put that potentially on Abstral versus

Yigal, this is Mark Schwartz. Let me answer the first question then I’ll turn it over to Chris at a commercial, thank you for tuning in today. The guidance that we’re giving is $15 million to $18 million, we have not split that out and we’re not going to do that quite yet, I think until we get a little bit better handle for exactly how

Yes thank you for the question, I’ll pick up part two and part three. Starting with part three, we will not be distributing

Got it. Thank you. And then just one question on the PRESENT, what exactly is the data disclosure plan for the interim and if you pass and I say keep going, and safety looks good, do we hear anything or we're only going to hear something that's unlikely when you'd have to stop the study. Thanks.

No, it is a pre-planned analysis and it’s a futility analysis. So we will get a recommendation by the IDMC or the Data Safety Monitoring Board to assuming that, a path as a futility to proceed with the trial we will announce that.

Great. And then just one final question regarding the overenrollment in PRESENT, you referenced the words timing and quality of the statistics. Should we take that to mean that by overenrolling, you sort of compensate against potential dropouts that you maintain the power that was originally planned in the study or is there some other interpretation there on that, the benefit for over enrolling the study. Thank you.

Yes Yigal, thank you, Gavin Choy, here. That's precisely correct. So we’re going to over enroll by 5% to 10% accommodating those patients that got through screening and this will obviously compensate also for the potential increase drop out rate.

Great. Thank you very much.

Thank you. Our next question comes from the line Mara Goldstein from Cantor Fitzgerald. Your line is open.

Thanks very much for taking the questions. Thanks for the slides this quarter it’s very helpful. I have a question on the commercial side first and on prescription, I understand the discussion around the vouchers being counted as prescriptions and what not. But if you look into the first eight weeks or so from the first quarter, the trends are still slightly down relative to the fourth quarter. So, I don’t know if you can put this sort of on an apples-to-apples percentage first, I mean I understand the dollar value of a script is higher and you can definitely see that dynamic in the percentage of higher dose prescriptions. But just in terms of an absolute comparison between what was vouchers versus non-vouchers from just the prior quarters, this quarter?

Sure Mara, thank you very much for the question. I could actually probably thinking a little further back for you. Initially when we launched our patient assistance program at it's peak 75% of our business was voucher business, currently in 2015 through the first two months, only 10% of our business is coming through the voucher. So we've actually made some dramatic improvements there and you’re right, our prescriptions have fluctuated month-to-month. Overall the trend line is positive and we continue to focus on steel demand while improving profitability at the same time.

Okay. And can I ask you a question on just sort of the procedural timing on the litigation around the patent for Abstral, what are the next kind of data points that we should be thinking about?

The litigation is fairly expanded litigation, it has really just started and Mara I’m not sure I can give you a really hard answer on that is with any litigation. I think our expectations in a general sense that is going to be fairly long and protracted. So I don’t know that there is going to be any news for quite a while and probably within 12 to 24 months from maybe the first set of motions and activities and I would anticipate it to go after the full 30 months stay. So I would not anticipate any news shortly.

But that 30 months stay is relatively close to the patent expiration anyway correct, I mean so then six months? Right.

You're correct.

Okay. All right and then can I ask one more question on also kind of statistics question on present trial?

Yes, yes please.

Okay. So first looking in the interim futility, I’m just wondering given there has been so much discussion around statistics and clinical trials in immunotherapy and late effect of all the benefit occurring to the tail, what's the profitability that you hit that you have a futility measure but that’s a function of being having a late effect does an early effect, I mean should we even be thinking about?

I think Mara you raise a good point and you’re right depending on some of the mechanistic elements, a lot of immunology studies have shown a late effect. I think two things from an empirical point of view in the Phase II trials that's not what we saw, we actually saw reasonably quick effect given the nature of the mechanism. As well futility analysis is about half way through the trials so we’re looking at 70 events, it’s pretty far along into the trial on a relative basis and I think we should be past that point of futility in relation to the signal out we’re measuring.

Okay. All right thank you. I will jump back in.

Thank you. Our next question comes from the line of Joe Pantginis from Roth Capital Partners. Your line is open.

Good afternoon. Thanks for taking the question and thanks also for the details today. Couple of question on presenters well and the approach of NeuVax, I guess can you remind us at this points how the screening process went, how many patients you needed to screen and how the efficacy of the screening went?

Yeah thank you Joe for the question. So we screened over 3300 patients. As you know it is protractive screening process. Overall the overall screen failure rate has – is fairly high I would say, at about 75% screen failure rate.

Okay, great. That's helpful. And then with regard - Mark, you made some comments earlier one of your slides obviously about the importance of T cells and I guess I am asking for a little bit of reminder here because I think some intriguing data came out of the Phase I, II. Basically can you remind us about the level of T cell recruitment that you saw in earlier studies, I believe it was some of doctor people’s data?

Yes exactly Joe, this data has been published but in the Phase I, II studies, we saw as high as about 2% of the total T cell population was in fact NeuVax specific or E75 targeting HER2. And so we can generate a very potent T cell response. And I think that take home message of the point I was trying to make in the few slides is that, I think a lot of the excitement around checkpoint inhibitors is an example, the two recently approved drugs is that clearly the immune system can be a very effective mechanism for targeting cancers. It has taken some time to find exactly the right pathway to get there. But the essence of a checkpoint inhibitors really taking a breaks off and allowing the T cell to do it’s job. I think we’re coming at exactly that same endpoint allowing the T cell to do it’s job, we are just approaching it from a slightly different perspective. And we believe that one of the key elements of that is after setting is really appropriate that it's a setting with a low disease burden, a very healthy immune system. And so we’re getting at a same point in many respects as a checkpoint inhibitor is a very active T cell hunting down and targeting tumor cells in our case they're micrometastases or called tumor cells in what is otherwise a healthy women.

And thanks for that and that was the magic number I was looking for and I guess can you just put into perspective for everyone, I mean 2% that’s a quite a massive number of the T cell compartment isn't it?

It is that's actually very high - it would be uncommon to find a single target throughout the T cell population at high. I believe there's what over trillion T cells in the body. So 2% represents a significant number of cells given at. In fact one T cell can lyse through it’s mechanism lysis, the lysis mechanism A cancer cell. And again, the setting is what’s really key for us in that we are in a setting of otherwise healthy immune system targeting either single occult cancer cells or micrometastases so we are not trying to kill and remove a tumor mass or metastatic tumor, but really isolated tumor cells.

And then I guess the last question is on the slide with regard to expanding into other indications sort of the secondary and tertiary level of indications. You said you’re going to look at that, with regard to cost management and what have you. Do you have any potential that you’re looking at potential IFPs that could also potentially reduce cost?

We do – you're spot right on, we have a number - there is nothing that we can announce at the moment, we've got – do have several discussions ongoing. We're looking at a number of additional immunotherapy, a couple of checkpoint inhibitors to see how to leverage new access T cell population increasing capability with other additional mechanisms that will allow us to go after either different indications or different settings that NeuVax alone may not be quite as efficient in much like we are with NeuVax Herceptin. So stay tuned throughout 2015, nothing that we can announce at the moment, but certainly a number that we’re pursing in discussion we're in process.

Thank you.

Thank you. And our next question comes from the line of Robert LeBoyer form Maxim Group. Your line is open.

Last quarter you had a decrease in sales over second quarter and first quarter and then this quarter we had a nice recovery. The thing that was attributed to last quarter was inventory and the wholesaler stocking levels. Could you describe the percentage of the sales that were due to restocking of that the due to pipeline and the supply chain, and also with

Hi Robert, it's Chris I’ll take the first part of that question and I’ll allow Ryan to answer the second part. Yes we had a much larger Q4 and our field demand or that demand driven by customers almost exactly matched what we’re selling to the wholesalers. So we saw a nice leveling off moving from Q3 to Q4. And you do see some up and downs here. But overall the trend has been positive and we’re learning how to manage the inventory at the wholesaler levels.

Hi Robert, Ryan Dunlap, I’ll take the second part of your question. Thanks for the question. With respect to the

Thank you.

Hi this is Jason Kolbert. Can we just have one quick follow up too. I would like to just migrate back to NeuVax for a second. Help me understand what the historical control rates are for recurrence and how reliable those figures are and what assumptions you made in terms of the initial trial design so that we can ultimately understand how reliable the powering of the trial might be.

So the historical recurrence rate for node positive HER2 1+, 2+ breast cancer patients is about 25% over three year. And that data actually has been fairly steady for the last five or 10 years and there is actually some fairly recent trials in similar patient populations that have published, that really confirmed that rate, I think the number they are coming in at 23.5% if I'm not mistaken. So it's right around that same number. And so I think our assumptions going into the trial are still valid by the current data and I think that's a statistics, and you raised a good point because a lot of time the standard of care changes and things improve and patients, the assumptions at the beginning of trial don't hold up by the end of the trial but so far the data that we've been able to look at has indicated that the recurrence rates are still at about the same rate that they were when we set the trial up and did the original stats plan.

Thanks guys. That's really helpful. I'm sure you saw and we all saw the deal this week between Bavarian Nordic and Bristol-Myers Squibb and the combination of a checkpoint yet another vaccine. So it really seems like you are on the right space.

Thank you. And I think it just validates obviously immunotherapy area as a whole but more importantly I think the ability of vaccines to demonstrate their efficacy and ultimately gain their recognition value that they deserve as we learn how to best use them and what the appropriate settings are.

Thanks guys. We are really excited watching this trial and you understand all the reasons why. Thank you so much.

Thank you. Our next question comes from Rahul Jasuja from Noble Life Science. Your line is open.

Hi everybody. Quick question on NeuVax, that's probably for Mark or Gavin here. So Mark I recall that there was the initiative to measure circulating tumor cells and that was something that - I know it's clearly expensive to do that and that was part of the protocol where you mentioned CTCs before and periodically during the trial as well as after. Now number one, if you could add some more color on that, and number two, it was clear that as you found a decrease in CTC, there was a corresponding increase in CTA T cells from your earlier work. In the interim analysis, would that be any criteria that will be measured and will that be disclosed?

Rahul, thank you for the question, Gavin here. You are correct. CTCs are part of the trial as built into the trial. As you might suspect, if we saw the data we would likely unblind the trial. So the data is being collected but we are not aware of the data and as unlikely at the interim analysis, we would know of that data set.

And how frequent is the CTC measurement, is it at the onset, and then periodically every several months or have you not disclosed that about the CTC measurement?

Correct. It's at baseline and periodically through the treatment course.

Okay. All right, thanks. That’s all I had.

Thank you. I would now like to turn the call back over to Mark Schwartz for any closing remarks.

I want to thank everybody and appreciate your time this afternoon. I know it was a bit of longer call than normal. But there is a lot of good information and I hope that the slides really helped as we made our key points. Thank you very much everybody.