Immune Design's (IMDZ) CEO Carlos Paya on Q4 2016 Results - Earnings Call Transcript

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Immune Design Corp. (NASDAQ:IMDZ) Q2 2016 Earnings Conference Call August 9, 2016 4:30 PM ET

Executives

Stephen Brady - Chief Financial and Accounting Officer

Carlos Paya - President and Chief Executive Officer

Christopher Whitmore - Vice President of Finance and Administration

Analysts

Brian Abrahams - Jefferies

Rich Goss - Leerink Partners

Boris Peaker - Cowen & Company

Operator

Good afternoon and thank you all for joining Immune Design’s Second Quarter 2016 Conference Call. At this time, all participants are in a listen-only mode. Following managements’ remarks, we will hold a brief question-and-answer session, and at that time the lines will be opened for you.

I would now like to turn the call over to, Stephen Brady, Executive Vice President, Strategy and Finance at Immune Design. Please go ahead.

Stephen Brady

Good afternoon, and welcome to Immune Design’s second quarter 2016 conference call. Today, we’ll summarize the quarter’s financial results and update you on the Company’s progress. Copies of our press releases are available in the Investor Relations section of the Company’s website at www.immunedesign.com. Today’s call is being recorded and will be available for replay shortly after the call for 90 days in the Investor Relations section of our website. Today’s call will also be available for telephone replay shortly after this call for five days through the dial-in information located in today’s press release.

Joining me on the call today from Immune Design are Dr. Carlos Paya, President and Chief Executive Officer; and Mr. Christopher Whitmore, Vice President of Finance and Administration.

Before we start, I would like to remind you that today’s call will include forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by these statements. Forward-looking statements contained on this call include, but are not limited to, statements about the expected mechanism and clinical results for CMB305, LV305, G100 and ZVex-Neo, the timing and scope of clinical trials, the reporting of clinical data, the design of current and future clinical trials and the Company’s future financial results.

Such statement represents management’s judgment, expectations and intentions as of today and involve assumptions, risks and uncertainties. Immune Design undertakes no obligation to update or revise any forward-looking statements. Please refer to our current and future filings with the SEC, which are available from the SEC or on Immune Design’s website for information concerning the risk factors that could affect the company.

Before I turn the call over to Carlos who will provide an update and discuss the company’s progress, I will review our financial results for the second quarter ended June 30, 2016.

Beginning with net loss, net loss and net loss per share for the second quarter of 2016 were $14.3 million and $0.71 respectively, compared to $10.5 million and $0.54 respectively for the second quarter of 2015.

Revenue for the second quarter of 2016 was $1.1 million and was attributable primarily to revenue received pursuant to Sanofi collaboration for G103, our HSV2 therapeutic vaccine program as well as GLA product sales to collaboration partners.

Revenue for the second quarter of 2015 was $1.8 million, and was attributable primarily to collaboration revenue associated with the G103 program. Research and development expenses for the second quarter of 2016 were $11.4 million compared to $8.5 million for the second quarter of 2015.

The $2.9 million increase was primarily attributable to continuing advancement of Immune Design’s ongoing research and development programs including ongoing Phase I and Phase II trials.

General and administrative expenses did not materially differ over the comparative period. For the second quarter of 2016, G&A expenses were $3.9 million, compared to $3.8 million for the second quarter of 2015.

On a year-to-date basis, net loss and net loss per share for the six months ended June 30, 2016 were $26.6 million and $1.32 respectively, compared to $19.9 million and $1.10 respectively for the same period in 2015.

Revenue for the six months ended June 30, 2016 was $3.0 million and was attributable primarily to collaboration revenues associated with the Sanofi G103 collaboration and GLA product sales to collaboration partners.

Revenue for the same period of 2015 was $3.7 million, and was attributable primarily to collaboration revenue associated with the G103 collaboration. Research and development expenses for the six months ended June 30, 2016 were $22 million compared to $16.9 million for the same period in 2015.

The $6 million increase was primarily attributable to continuing advancement of our ongoing research and development programs including ongoing Phase I and Phase II clinical trials and an increase in personnel-related expenses to support the company’s advancing, research and clinical pipeline.

General and administrative expenses did not materially differ over the comparative period. For the six months ended June 30, 2016, G&A expenses were $7.9 million, compared to $7.6 million for the same period in 2015.

Finally, Immune Design ended the second quarter of 2016 with $92.6 million in cash, cash equivalents and short-term investments, compared to $112.9 million as of December 31 2015. Net cash used in operations for the three and six months ended June 30, 2016 was $8.3 million and $20.4 million respectively.

With that, I’ll turn the call over to Carlos.

Carlos Paya

Thank you, Steve. And before I begin my comments, I would like to thank you all for joining our call. During the second quarter of 2016, we presented data from both of the company’s two approaches in immuno-oncology at the AACR and ASCO annual meetings, as well as our company opted event for investors and analysts post-ASCO.

These data provides a rational for advancing the development of our two lead programs CMB305 and G100, which offers the distinct approaches to fighting cancer by modulating the patient’s own immune system without ex vivo manipulation.

In our specific antigen approach, we now have two separate programs, CMB305 and ZVex-Neo. CMB305 is our lead product candidate in this approach and is undergoing testing in Phase I and Phase II trials targeting NY-ESO-1 expressing solid tumors.

ZVex-Neo is a new program earmarked to undergo clinical testing next year and will target a patient’s individual tumor antigen. CMB305 is a sequential combination of two agents, LV and G305 and is aimed at generating a safe, durable and effective anti-tumor memory T-cell response within the patient targeting NY-ESO-1 expressing solid tumors.

Data presented at ASCO from the completed Phase I LV305 single agent trial in 24 patients with NY-ESO-1 positive soft tissue sarcoma indicates the following: clinical benefits for 58% of the patients in the form of partial response or stable disease. PFS of 4.6 months on a median OS that have not yet been reached with 81% of the patients alive at one year and a very favorable safety profile with only grade one or two AEs.

Early preliminary data from the first 14 patients in the ongoing CMB305 Phase I single agent trial for sarcoma presented at our company update post-ASCO indicated the following. The median OS had not been reached with 93% of the patients alive at one year and the median PFS was 5.5 months.

A favorable safety profile with only grade one or two AEs and a deeper immune response than seen in the LV305 Phase I study including a trend of increased T-cell clonality. In later stage development, our ongoing randomized Phase II combination study in two soft tissue sarcoma with or without Genentech’s anti-PDL1 TECENTRIQ or atezolizumab is actively enrolling.

An independent data monitoring committee reviewed the safety data from Part 1 of this study allowing us to proceed to Part 2 in which patients are being actively enrolled. This is a randomized 80 patients Phase II trial starting atezolizumab in one arm and a combination of CMB with atezolizumab in the other arm.

Enrollment for this trial remains on course and in lieu of releasing preliminary data at year end, we intend to submit an abstract for ASCO 2017 and anticipate having the opportunity to present a robust dataset at such meetings.

Altogether, the learnings from these completed and ongoing trials indicate that it is possible to safely generate indigenously a long-term and durable memory T-cell response against NY-ESO-1 that appears to impact the course of multi-treated metastatic sarcomas.

The stabilization of tumor growth and potential impact on overall survival appear to be the hallmarks for the 305 programs in sarcoma patients. These tumors have a high unmet medical need as current chemotherapeutic options have safety concerns and do not significantly affect overall survival.

Based on this data and the orphan drug designation from both the European and US regulatory agencies, we are currently evaluating the optimal registration path for CMB305 in sarcomas.

Our second product from the antigen-specific approach and the ZVex platform is ZVex Neo. While we and others are working to prove that conserved cancer testis antigens such as NY-ESO-1 can be valid tumor targets against which a T-cell response can be generated, we are leveraging the insurance flexibility of our ZVex platform to expand its reach to tumor antigen that are unique to each patient.

Such antigens commonly termed neo antigens, generally resolve for mutations arising within the tumor and can be ideal targets having switch to generate a strong and durable T-cell response.

In May 2016, Immune Design announced a collaboration with Gritstone Oncology to together develop patient-specific immunotherapies in which the patient could receive a ZVex vector containing the patient’s own specific antigen identified from the tumor using Gritstone’s proprietary genomics and proteomics platform.

We are pleased to report that the collaboration has commenced with the intent to begin a ZVex neo Phase I study with Gritstone in patients with non-small cell lung cancer in 2017 in combination with a checkpoint inhibitor of the PD-1/PD-L1 axis.

Let’s switch now to our other immuno-oncology approach called Intratumoral Immune Activation. This is designed to generate a strong T-cell response against the tumor by directly using the tumor’s own antigens and its surrounding immune system. Our leading product candidate in this approach G100 is also progressing in clinical development.

At ASCO 2016, we presented final data from our Phase I study in patients with Merkel cell carcinoma. In this study, G100 was administered intratumorally as a single agent and in combination with radiation revealing the following: a 50% overall response rate per protocol including a complete response from our single agent G100 treated patients.

The only treatment related to AEs observed were grade 1 or 2. And we also observed significant changes of the tumor microenvironment in G100-responding patients in two broad categories, one, upregulation of the innate immune system including chemokine NK cells and M1 macrophages and dendritic cell antigen presentation markers.

And two, increased dynamics of adaptive immunities such as trafficking of CD4 and CD8 T-cells from the stroma into the tumor bed, underscoring the transition to a hot tumor.

In parallel and supported by strong pre-clinical data presented at ASH last December, we are actively enrolling in our randomized Phase II study of G100 with low dose radiation, in combination with Merck's checkpoint inhibitor KEYTRUDA or pembrolizumab in patients with follicular non-Hodgkin lymphoma.

Part 1 of this study which is a dose escalation of G100 with a fixed dose of low dose radiation without Keytruda has been completed and deemed safe by an independent data monitoring committee.

Part 2 of this study, in which patients are currently being randomized to receive G100 and radiation alone are in combination with Keytruda. As with the CMB305 trial, this trial is also actively enrolling and we intend to submit an abstract for ASCO 2017 and anticipate the opportunity to present at such meetings.

Lastly, we wanted to note that our scientific and clinical expertise in immunology and immuno-oncology has been further strengthened by additions to our Board of Directors of Dr. Susan Kelley who brings more than 25 years experience in oncology and immunology drug development to the company. We are happy to have her as part of the team.

With that, I will now turn the call over to the operator for your questions.

Question-and-Answer Session

Operator

[Operator Instructions] And our first question comes from Brian Abrahams from Jefferies. Your line is open.

Brian Abrahams

Hey guys. Thanks for taking my question and congrats on all the progress.

Stephen Brady

Thanks, Brian.

Brian Abrahams

So, I guess, my first question would be, I know in the past, you’ve talked about some of the potential challenges moving into lung with NY-ESO-1, with CMB305. I am wondering in light of some of the recent checkpoint data that we’ve all seen in the last week, did that change your view on the potential role of tumor-specific T-cell stimulatory approach might have in conjunction with a checkpoint in a lung indication and might to explore inclined to frontline lung indication in some sort of combination?

Carlos Paya

Yes, no, I think, great question. Our response would be that, it’s going to be antigen-dependent. When you look at the antigen-specific approach we don’t think NY-ESO-1 is an ideal target for non-small cell lung cancer. If you look at the expression of NY-ESO-1 it’s significantly lower in non-small cell lung cancer than in tumors.

So, the application of CMB305 in lung is final idea. However, there are additional antigens in lung that are also concerns and we could envision our next product coming off from the pipeline which we are actively looking into where you could now potentially combine multiple antigens many of which could be expressing lung cancer and then be able to have a much more broader conserve antigen type immuno therapy.

The fact that, for example with neo antigen, we are moving to lung and also based on the recent data from both femoral and Nivolumab in lung first-line as you all know for the last few days, I think that is a perfect match for us. Mutations in lung are very common like melanoma and so I think it’s a generic opportunity for us to test the ZVex platform in collaboration with Gritstone using one of those checkpoint inhibitors in ideally first or second line and that’s all to be discussed as we move forward to the collaboration.

So, the answer is, yes, I think now we have, compared to a year, two years ago a better sense that conserved antigens are really valid target antigens for active immuno therapy and now we have the possibility to also go now to individualized mutations unique to each patient. And so I think that is – I think showing all of us that we can use our technologies broadly in those two manners.

Brian Abrahams

Makes sense. And then, I guess, sort of along those lines, are you planning to explore any additional solid tumor indications with CMB305 beyond sarcoma? Or is the right way to think about it now that the focus, because you’ve advanced so quickly with the neo antigen collaboration and capabilities that the focus will be more on ZVex neo for some of the additional solid tumor indications?

Carlos Paya

So, I think, we have always, as part of drug development, you have to have your leading indication on general life cycle. So we have clearly chosen sub types of soft tissue sarcoma, those are high NY-ESO-1 expressers as the best opportunity for CMB305 first and foremost.

But there are, as you know additional indications, for example, you have both myeloma and ovarian and bladder are potential life cycle opportunity for CMB305. As a small growing company focuses the most important part and so we are really aggressively pursuing what would be the registration path for an early to market approach with CMB305 in sarcoma without excluding our priority any other life cycle of those tumors.

Now going to lung, we believe that NY-ESO-1 is not the right target for lung and therefore that we are so excited to do this collaboration with – because it can really put now, for the first time a modern active immunotherapy in the context of better potentially immunogenic antigens plus the knowledge we’ve all gathered over the last two years on checkpoint inhibitors. It could be a real terrific combination for that type of tumor.

Brian Abrahams

Got it. And one more question if I may, then I’ll hop in the queue. In terms of the potential for a faster path in sarcomas, I think, initially, you had mentioned that there was the possibility of getting some interim data or some interim read even internally that could potentially support the initiation of registration discussions with regulators by the end of this year. Is that still the plan or is the plan now to wait until you have a more fulsome dataset before approaching the FDA?

Carlos Paya

Without barring fixed deadlines I think that, yes, the plan is to go as quickly as we can when we have a solid package from the single agent approach as mentioned around the ASCO data that we have stocked. I mean, our surprise was to see significant impact on overall survival.

The numbers that we saw at one year are very unusual based on everything we’ve learned on chemotherapeutic agents and, again, as we get closer to the three year mark, these data if supported would be really different from everything else. So I think we have a great opportunity to discuss with regulators what kind of registration path we could both agree with a single agent type approach.

And so that is on the works and that’s not being planned and actively addressed. The other potential opportunity we have is these randomized trials we are doing with atezolizumab where its nicely randomized and we will be able to see when we have the whole package, is there any significant impact of this combination.

And I think that does not exclude that we could potentially register the drug in both approaches, one with earlier stage metastatic patients with single agent and then maybe one with later-stage patients where you need potentially a combination with checkpoint inhibitors.

So all that is on the table and just to make sure that all of you know that we are working hard in trying to come up with the right answer to one of those two passing on both.

Brian Abrahams

It’s very helpful. Thanks, Carlos.

Carlos Paya

Thanks.

Operator

And our next question comes from Jim Birchenough from Wells Fargo Securities. Your line is open.

Unidentified Analyst

Hi, thanks for taking the call. This is [Indiscernible] in for Jim. Two questions from us. One is on the ZVex Neo platform. Just curious in what might the strategy be here? Will it involve patient-specific anti-viral vectors and the feasibility of this approach? And then I have a follow-up.

Carlos Paya

Yes, it’s a great question. Thank you. If you have followed the approach of the ZVex expressing NY-ESO-1 which is obviously a byproduct with the same concept, the only difference would be that, we would be shifting from an off the shelf in the case of the LV305 means that, you are a patient that has a tumor expressing NY-ESO-1, you will be able to receive LV305 or CMB305 and here we are now changing from an off the shelf to individualized.

And here the whole concept would be that, working together with Gritstone, Gritstone’s technologies would identify the likely subset of mutations that are likely to be immunogenic in the patients. We would clone those sequences in the ZVex vector and administer that to the patient with a expectation of creating either a de novo T-cell response against those mutations and/or a boost of pre-existing T-cells.

And so the only shift would be that instead cloning NY-ESO-1, we will be cloning in the specific mutations from each patient. And the feasibility is going to require the team working together which were restarted and getting regulatory alignment as to how to develop these individualized approach, the first time this will be done. And so that’s one area that we are working together.

The area would be the manufacturability of this approach and like with the LV305 where we started at one level, we’ve been able to improve significantly the cost of goods approach and that will be the same application we will be doing to that. Those are the two areas we are working hard. So when we get into the clinic hopefully next year, we can be able to learn and address those issues.

Unidentified Analyst

Great. Thanks. Then, a question on CMB305 and specifically on the role of G305, great data in sarcoma from the CMB305 study. I guess that the assumption is that the G305 serve as a boost. So it helps to augment the response of LV305. But I am wondering have you evaluated whether G305 itself has single agent activity and whether that should be – for example, further pursuit is the anti-PD-1 combination?

Carlos Paya

Yes, we did a Phase I of G305 in a mix bag of way in tumors. What we are seeing with that approach is that, we are seeing the right immunological boost. But we shied away from developing as a single agent alone or in combination with PD-1 because it resembles more the call it traditional or previous cancer vaccines where you are delivering proteins and an adjuvant and we observed and I think it’s been the case for the past approach is that, that is not sufficient to really give you that kind of CDA T-cell response at memory and long lasting.

So while we see variable as a boost. We don’t believe that by itself is potentially effective as complementing it to LV305 or LV305 alone. So we took a decision a year and a half ago, once we deem that it was safe and we had what appeared to be a immunological dose to just using as a boost.

And so that’s how we are right now. There are other ways we can boost also the LV305 or the ZVex platform. That could be also not yet – we have fullest protein and so we are also looking at that as part of the future pipeline and so we do see the vector they are kind of core to prime and immune response and then potentially use G305 like approaches or other boosts approaches to then enhance even more the T-cell memory that’s being generated with the vector platform. I hope that answered your question.

Unidentified Analyst

Great. Yes, thank you.

Operator

Thank you. And our next question comes from Seamus Fernandez from Leerink Partners. Your line is open.

Rich Goss

Hi, this is Rich Goss, going for Seamus. Thanks for taking my questions. Congratulations on all the progress. Just regarding the ZVex Neo, I was wondering if you could just expand a bit on whether you currently see any unique regulatory hurdles for neo antigen-based vaccines and how the FDA and other agencies approach the safety as a personalized therapy such as this?

Carlos Paya

Great question. So when we sat down, as I mentioned, probably in the last earnings call, we were really – one of our goals for the company was to explore the applicability of our technologies to neo antigens. We talked to a number of companies and again, we chose Gritstone, because exactly to your question, we need to work now as a team to find out what are the key regulatory questions coming up.

And so, that’s part of our joint effort right now and as more information comes through, we will be able to share those both companies together. I can say that, you have gone through an individualized approach already with engineered T-cell receptors or CAR Ts, those are per se, engineered or ex vivo, they are even more complicated and have additional manufacturing hurdles and those have been very clear from the perspective of regulatory initial trials to go ahead.

So, I would say, there is all those already present there or this would be a first time we do this. I am very curious and excited about what regulators are going to say about this. But we have the best teams on both sides working on this and it’s going to be a real nice journey and we will be able to hopefully to share with all of you guys as this would be our first in human doing this approach.

Rich Goss

Okay, great. Thank you.

Operator

And our next question comes from Boris Peaker from Cowen. Your line is open.

Boris Peaker

Great. Thanks for taking my questions. My first question is, at the post-ASCO event, the median OS has not been reached for either LV305 or CMB305. I am just curious as the time has progressed and patients have progressed further, do you have an estimate of when we should see the OS data or when the OS will be reached at least?

Carlos Paya

Yes, we keep following these patients as LV305, all the patients that we presented. There are no more patients that were enrolled thereafter. So the first 24 patients are the ones we keep following and as mentioned, that was, I believe around 83% one year survival without OS.

The CMB305, we presented preliminary data in 14 and we have additional patients that were involved thereafter. And so, back to kind of the message we are getting today is we would like to have more complete set of data before we present that and so, I can give you any guidance of timing, but what we want to do is make sure we have solid robust data and now that we understand that this drug works and impacts potentially overall survival.

So we have enough follow-up to be able to provide that. But as soon as we have that solid package, we will be able, hopefully to present those, hopefully at our international meetings.

Boris Peaker

Great. And so I am just wondering also for the patients that are in the LV305 and CMB305, particularly in LV305 is all have already been enrolled and being followed, have you looked at the patients specifically that didn’t get a benefit from treatment and to look at their biomarker and just try to understand why those patients, if there is anything unique about those if they had maybe lower level of NY-ESO-1 or high level of Tregs? I am just making – guessing here, but I am curious if you’ve made any observation there?

Carlos Paya

Yes, so, the observations I would just say, once that we shared in May is, it appears that all our patients were at a high NY-ESO-1 expressers. So it’s going to be difficult to say whether a low NY-ESO-1 expresser does not benefit. So, unfortunately, we can’t dissect that answer.

We do have the T-cell data from those patients that were gathered through the therapy period which is not more than three months. Even though as you know, we did follow some patients up to two years and still found long-term memory T-cells. So, just to make the answer short, we are looking at all those things more with LV, so with CMB we will be able hopefully to retrospectively value that.

Also in the ongoing CMB305 study with atezolizumab, we are also curious to see whether the addition of a T-cell brings or allows us to see even more detectable T-cell against NY-ESO-1 and T-cell arm alone. So, this is also going to be biopsy studies then on that arm.

So I think we are going to get after kind of these three trials both the single arm and the randomized trial completed as a dataset, I think we can be able to better answer how that is novel way of delivering antigens to our patients that we think works from predicting who is going to be a responder versus not. So hopefully, again, I can give you the answer now, but we are really focused on doing that investigation.

Boris Peaker

Gotcha. And on the atezolizumab combo Phase 2, do you have any sense of how many patients you think you may have by ASCO 2017? I am just wondering, it’s going to be a pretty large dataset already at ASCO or is it just going to be, just a small initial cohort?

Carlos Paya

Again, as this trial is enrolling, we will have a subset of patients that have longer-term follow-up and others that will have low – less follow-up than the initial ones, but our intention is that the data at ASCO should be significant and hopefully include the majority of the patients in the trial and the only thing will be how many patients have what kind of follow-up at that stage, but I think that the way the trial is going, we expect to have a significant solid data by then.

Boris Peaker

Gotcha. And my last question, do you anticipate presenting any results at medical meetings still in 2016?

Carlos Paya

No, some data we have submitted most likely, I would say, exciting preclinical on next-generation type products coming up in the next meetings. From the clinical perspective, we are really kind of back to the basics of having hopefully a complete study finished and well analyzed and that’s where we are putting the data for ASCO.

Boris Peaker

Gotcha. Okay, well, great. Thank you for taking my questions and congratulations on the progress.

Carlos Paya

Thank you, Boris.

Stephen Brady

Thanks, Boris.

Operator

And at this time I am showing no further questions. I would like to turn the call back to Carlos Paya for any closing remarks.

Carlos Paya

Thank you, operator and thank you everyone for your questions and taking the time to listen to our call and we look forward to speaking with you throughout the second half of the year and I appreciate everyone’s attention. Thanks.

Operator

Ladies and gentlemen, thank you for your participation in today’s conference. This concludes the program. You may now disconnect. Everyone have a great day.

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