Bellicum Pharmaceuticals, Inc.'s (BLCM) CEO Rick Fair on Q4 2018 Results - Earnings Call Transcript

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About: Bellicum Pharmaceuticals, Inc. (BLCM)
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Earning Call Audio

Bellicum Pharmaceuticals, Inc. (NASDAQ:BLCM) Q4 2018 Results Earnings Conference Call March 12, 2019 5:00 PM ET

Company Participants

Atabak Mokari - Chief Financial Officer

Rick Fair - President and CEO

Bill Grossman - Chief Medical Officer

Aaron Foster - Head, Research

Conference Call Participants

Biren Amin - Jeffries

Jim Birchenough - Wells Fargo Securities

Wangzhi Li - Ladenberg

Peter Lawson - SunTrust Robinson Humphrey

Reni Benjamin - Raymond James

Operator

Ladies and gentlemen, greetings. And welcome to the Bellicum Pharmaceuticals Fourth Quarter and Full Year 2018 Financial Results. At this time, all participants are in a listen-only mode. A brief question-and-answer session will follow the formal presentation. [Operator Instructions]

As a reminder, this program is being recorded. It is now my pleasure to introduce your host, Atabak Mokari, Chief Financial Officer. Thank you. You may begin.

Atabak Mokari

Thank you. Good afternoon, everyone, and thank you for joining the call. With me today is Rick Fair, Bellicum’s President and Chief Executive Officer; Bill Grossman, Chief Medical Officer; and Aaron Foster, Head of Research.

Earlier this afternoon, Bellicum released financial results for the fourth quarter and full year ended December 31, 2018. If you have not received this release or if you would like to be added to the distribution list, you can do so on the Investor Relations page of the company’s website.

As a reminder, today’s conference call will include forward-looking statements made under the Private Securities Litigation Reform Act of 1995, including statements regarding our research and development plans, clinical trials, plans regarding regulatory filings, review and approval of our product candidates, commercialization expectations and our financial outlook.

These forward-looking statements involve a number of risks and uncertainties and reflect our opinions only as of the date of this call. We undertake no obligation to revise or publicly release the results of any revision to these forward-looking statements in light of new information or future events.

Actual results may differ from those indicated by these forward-looking statements due to numerous factors, including those discussed in the Risk Factors section of our Form 10-K for the year ended December 31, 2018 filed with the Securities and Exchange Commission.

And now, I’ll turn the call over to Rick.

Rick Fair

Thanks, Atabak. Good afternoon, everyone, and thanks for joining us. I’m excited to share with you today to progress we’ve made across our pipeline controllable cell therapies, as well as our key objectives for 2019. On our call today, I’ll provide an update and outline 2019 goals for our two strategic priorities, namely our GoCAR-T pipeline and rivo-cel.

Before I do I’ll begin with a brief reflection on my time at in Bellicum as context for our 2018 accomplishments and future prospects. Over the last two years, we’ve made significant progress in strengthening our organization. We recruited a new executive team with deep expertise, we’ve improved our capabilities across the company in particular in clinical development and we’ve instilled a patient focused culture built a great science, performance and accountability.

While Bellicum is always had exciting science and technology we work hard to match that with great execution, progressing product candidate efficiently to and through the clinic and proofs of these efforts is in the results.

In 2018, we set a company record for achievement of our corporate goals and objectives, which included, presentation of initial data from our BPX-601 study, progression of two preclinical dual switch GoCAR-T programs, with expected IND applications into 2019, completion of enrollment in our pediatric trials for rivo-cel and presentation of late interim analyses from these trials, initiation of launch preparation for rivo-cel in Europe for pediatric patients, initiation of THRIVE, a Phase 2/3 study for rivo-cel in adult and adolescent AML and MDS patients, and completion of the second phase of our Houston cell and viral vector manufacturing facility.

In addition to this goal attainment, we continue to recruit and develop top talent, as evidenced by our recent appointment of Atabak Mokari as CFO, promotion of Aaron Foster to Senior Vice President and Head of Research, and addition of Judith Klimovsky to our Board of Directors.

We also recently formed a new Scientific and Clinical Advisory Board comprised of leading academic clinicians and scientists to provide valuable external perspective on our programs. In short, I believe we’ve laid the foundation for even more progress in the coming years.

With that look back at context, let’s turn now to our two strategic priorities, starting with our GoCAR-T pipeline. Our GoCAR-T platform incorporates our inducible MyD88 and CD40 or iMC activation switch.

As a next-generation CAR-T platform, we believe iMC may improve upon current generation products in several ways.

First, costimulatory molecules MyD88 and CD40 enhanced T-cell proliferation and persistence.

Second, our preclinical research suggests iMC may modulate the tumor microenvironment by overriding common inhibitory pathways, such as PD-1, PGE2 and TGF-beta.

Third, we believe that iMC may enhanced host immune activity to complement CAR-T efficacy by inducing pro-inflammatory cytokines and chemokines time.

Lastly, because iMC is driven by our switch technology we can control the timing and frequency of CAR-T cell activation through the infusion of our small molecule rimiducid, which may enable clinicians to better manage the benefit risk profile and treatment.

As you know, our first GoCAR-T product candidate is BPX-601, which target prostate stem cell antigen or PSCA. At the ESMO Immuno-Oncology meeting in December and ASCO GI in January we presented data from Part 1 of our ongoing Phase 1/2 dose escalation study in patients with late line metastatic pancreatic cancer expressing PSCA.

In the study, a total of 12 patients with advanced disease were treated with escalating doses of BPX-601 cells in a 3+3 design. In the early safety evaluation, the trial is not designed conservatively. Patients received a reduced lymphodepletion conditioning regimen consisting of cyclophosphamide only. Three patients received a low dose of BPX-601 cells only and the other nine received a single dose of rimiducid to activate iMC once following BPX-601 treatment.

The interim results proved encouraging, despite inadequate lymphodepletion, a single administration of rimiducid to activate iMC and the extreme challenge of treating second to sixth line pancreatic cancer. Initial data demonstrated that BPX-601 cells have a promising safety profile, with no reported cytokine release syndrome or other high-grade treatment related adverse events. In addition, a single dose of rimiducid led to enhanced cell expansion and prolonged cell persistence in several patients, providing first proof of concept of iMC in human.

Furthermore, the data provided preliminary evidence of clinical activity and disease control with four of six efficacy evaluable patients achieving stable disease, two of whom experienced tumor shrinkage greater than 20%.

As this is our first human experience with iMC, we are still learning quite a bit. We’ve amended the trial to include standard cyclophosphamide fludarabine or Cy/Flu conditioning and have expanded eligibility to gastric and prostate cancer patients expressing PSCA, with the intent of strengthening the early efficacy signal we’ve seen. We expect to report initial results from this patient cohort midyear.

Once we complete the safety evaluation of the Cy/Flu cohort, we plan to amend the BPX-601 trial to allow for scheduled repeat dosing of rimiducid in order to reactivate iMC over time. As a reminder the iMC switch was designed to be activated on a regular basis.

Our preclinical experience suggests that regular rimiducid dosing can reactivate and expand GoCAR-T cells over time without creating T-cell exhaustion, maximizing the clinical efficacy potential. We expect initial results from this patient cohort by the end of this year.

Based on the totality of data to-date we’re optimistic about BPX-601 as a product candidate and as a proof of concept for our GoCAR-T platform. We’re excited to advance to controllable dual switch GoCAR-T candidates into the clinic, with IND submissions planned for 2019.

Our dual switch platform incorporates both the iMC activation switch and the CaspaCIDe safety switch. We’re excited about this platform given the potential combination of efficacy benefits of iMC and safety benefits of CaspaCIDe, which may enable more aggressive treatment protocols that further enhance efficacy.

BPX-603 is Bellicum’s first dual switch product candidate and is designed to target solid tumors that express HER2. We selected HER2 as a target for BPX-603 because it is a thoroughly validated antigen for cancer therapy and academic CAR-T cell clinical studies have demonstrated antitumor activity.

Previous CAR-T approaches have been limited by modest efficacy and off tumor, on target toxicity. We believe that are dual switch technology may be uniquely suited to improve upon these earlier effort by driving greater efficacy through iMC activation, while enabling clinicians to manage any treatment-emergent toxicity with CaspaCIDe. We expect to file an IND application for BPX-603 and initiate a clinical trial in 2019.

Later in 2019, we expect to file an IND application for BPX-802, a dual switch product candidates targeting an antigen expressed in hematologic malignancies. We will discuss the target rationale later this year as we get closer to IND submission.

Now turning to our other strategic priority rivo-cel. We presented late interim analyses of our pediatric study at the American Society of Hematology Meeting in December of 2018. The interim results on 249 patients support our confidence and having a positive trial at the final analysis, as well as a commercially attractive profile.

The ASH presentation offered three important takeaways; first, the six months event free survival or EFS in Rivo-cel treated patients is trending ahead of EFS in patients undergoing matched unrelated donor or MUD transplantation. As a reminder, noninferiority on the EFS versus MUD transplant is our agreed-upon primary endpoint for European regulatory review.

Second, the data provided further evidence of the durability of efficacy of rivo-cel, with high rates of relapse free and overall survival, with a median follow-up of almost 2 years.

Lastly, the results demonstrated the efficacy of CaspaCIDe, as 70% of patients that developed advanced or steroid refractory GvHD, responded when retreated with rimiducid, a majority of which were complete responses. We expect topline results from this study in the second quarter and intend to submit European marketing authorization applications for rivo-cel and rimiducid in late 2019.

Looking ahead, we recently initiated THRIVE, a randomized global Phase 2/3 clinical trial, designed to potentially expand the registration of rivo-cell, both to the U.S. and to adult patients. The study is enrolling adult and adolescent patients 12 years and older, with intermediate and high risk acute AML or MDS.

In the Phase 3 portion of the trial, patients will be randomized to receive either the rivo-cel regimen or the Baltimore regimen, a T-replete haplo transplant followed by post-transplantation cyclophosphamide, which is the current standard-of-care in the U.S. and Europe in adults without an HLA matched donor.

Lastly on rivo-cel, I’d like to turn to the commercial opportunity that we see for this product. Based on the preparation we’ve done to-date and drawing upon my years of experience launching novel therapeutics and oncology and hematology globally, I’m excited about the commercial prospects for rivo-cel.

My excitement and growing confidence are supported by a number of factors. First, the addressable patient population is significant. Our initial addressable market opportunity in European pediatric patients is approximately 1,800 patients per year and is growing 4% annually. Our second lunch in adult and adolescent AML and MDS patients, would add almost 10,000 addressable patients per year in the U.S. and Europe to this opportunity.

Second, based on riov-cel’s compelling clinical value proposition and encouraging early feedback from KOLs and physician market research, we believe that rivo-cel has the opportunity to capture substantial market share. Specifically, we believe we have the opportunity to become the standard-of-care in haplo transplantation and also to penetrate the segment of patients who might otherwise have received a MUD transplant.

Third, we’re encouraged by our early payer market research and health economic analysis, which indicate payers will support favorable pricing and reimbursement consistent with currently approved cell therapies.

Fourth, our initial launch will require limited commercial investment. As the pediatric transplant market in Europe is highly concentrated. We estimate the top 75 European centers represent approximately 80% of the pediatric market opportunity.

Lastly, we’re excited about our recently recruited European commercial and medical leadership team, a talented experience group with a track record of successfully launching products. With them on Board, we’re making great progress toward our anticipated launch of rivo-cel in 2020.

With that, I’d like to hand the call over to Atabak to review our financials.

Atabak Mokari

Thanks, Rick. Bellicum reported a net loss of $27.2 million for the fourth quarter of 2018 and $98.0 million for the year ended December 31, 2018, compared to a net loss of $21.9 million and $91.8 million for the comparable period in 2017. The results include a non-cash share based compensation charges of $3.0 million and $13.8 million for the fourth quarter and year ended December 31, 2018, respectively, and $3.4 million and $13.6 million for the comparable period in 2017.

R&D expenses were $19.8 million and $71.2 million for the fourth quarter and year ended December 31, 2018, respectively, compared to $14.3 million and $65.7 million during the comparable periods in 2017. The higher expenses in the fourth quarter and full year 2018 compared to respective periods in 2017 were primarily due to an increase in costs related to our GoCART product platform and general research and development expenses, partially offset by a decrease and expenditures related to rivo-cel.

General and administrative expenses were $7.0 million and $25.0 million for the fourth quarter and year ended December 31, 2018, respectively, compared to $5.1 million and $20.0 million during the comparable periods in 2017. The higher expenses in the fourth quarter and full year 2018 compared to respected periods in 2017 were primarily due to increased personnel related costs due to hiring additional employees.

On the balance sheet front, as of December 31st, cash, restricted cash and investments totaled $98.0 million. Based on current operating plans, Bellicum expects the current cash resources will be sufficient to meet operating requirements through the end of 2019.

And now, Rick, I’ll hand the call back over to you.

Rick Fair

Thanks, Atabak. As you’ve all heard, we had a productive 2018, and anticipate many important milestones throughout 2019 for both our GoCART pipeline and rivo-cel. I’m proud of our team and all that we’ve accomplished together and I’m as excited as ever in the promise of our controllable cell therapy platform.

I’ll now open the call to questions.

Question-and-Answer Session

Operator

Thank you. [Operator Instructions] Our first question comes from the line of Biren Amin from Jeffries. You are now live. Sir, your line is on live.

Biren Amin

Okay. Can you hear me now?

Rick Fair

Yeah. We hear you now. Thanks, Biren.

Biren Amin

Okay. Hey, Rick. So thanks for taking the question. On 501, given the MAA filing in terms of [inaudible] presented this year, how are you thinking about the launch and can you just go through dynamics in Europe as it relates to Zelmacus [ph], which is on the market and what have been the issues with that launch and what are the key takeaway that you’re going to learn from the [inaudible]?

Rick Fair

Sure. Thanks for the question Biren. Yeah. So, as mentioned, we’ve assembled the leadership team in Europe that’s began launch preparation. We’ve already learned a lot from that. Of course 2019 and 2020 will be big planning years in anticipation of 2020 approval.

I think Zelmacus launch has been disappointing, I’m sure. And as we look at that analog, let’s say, two things strike us. One is, the product profiles are quite different. We have a stronger product profile. There are kind of three things that we think about there. One is, just a superior much larger and higher quality data package. Two, is a superior safety switch. So the intent of this product is to be able deliver the benefits of T cells, while managing the toxicity and our safety switch has been demonstrated to work more quickly and more comprehensively in patients.

I think the third thing is the construct that they’re using is immunogenic and so we’ve shown great evidence with our construct that we have durable cells that stay around long enough to provide adaptive immunity in these patients for a long period of time. And we think that leads to better efficacy profile to cells themselves. So I think those three ways our product profile stands out as being superior and that’s a positive.

I think the second piece of it is just launch preparation. It doesn’t appear from the outside looking in as they prepared much in advance for that launch and so they’ve been trying to do that post-approval and that’s difficult to do. We are well ahead of the game with the preparation underway two years prior to approval. We will be very ready to handle the pricing reimbursement aspects, KOL development aspects and the commercial launch upon approval.

Biren Amin

And then question on 601, do you think that you would need [inaudible] inhibitor to optimize activity of 601 at some point? I just wanted to get your thoughts on that? Thanks.

Rick Fair

Certainly it’s possible, and certainly, we are -- something we’re considering. I think we’d like to demonstrate some additional monotherapy activity in the study as currently constructed. So as you’ve heard we’re making modifications with that trial with the Cy/Flu lymphodepletion regimen and the repeat dosing of rimiducid to maximize the clinical activity in monotherapy but certainly expect the combination with the PD-1 or PDL-1 inhibitor could be a next step.

Biren Amin

And so when should we think about -- when you could enter into like a dose expansion phase where you would evaluate this type of tranche?

Rick Fair

So our current plans are to have the Cy/Flu cohort enrolled and presented midyear to amend the trial to allow for repeat dosing of rimiducid and begin enrolling patients such that we can present our first patients from that cohort by the end of this year and move into full expansion in prostate, gastric and pancreatic cancer in early 2020.

Biren Amin

Okay. Great. Thank you.

Operator

Thank you. Our next question comes from the line of Jim Birchenough from Wells Fargo Securities. You are now live.

Jim Birchenough

Yeah. Hi, guys. Thanks, for the taking the questions. Just a few. Just on rivo-cel to start with, when you think about the type of pricing discussions you are having and considering the approved product in Europe and pricing around that. Could you may be speak to the gross margins that we should be thinking about, should we thinking about CAR-T type gross margins or something better and I have got few follow-ups?

Atabak Mokari

Sure. I don’t think we can get specific on gross margins but I do you think the CAR-T pricing and cost of goods is a reasonable analog.

Jim Birchenough

And then maybe just comment in terms of turning to 601 and expectations for data midyear, with Cy/Flu preconditioning should we expect a more robust tumor responses or is this really still focus on safety and cell expansion, and will need maybe repeat dosing to expect durable responses, just trying to get a sense of expectation for the midyear data?

Rick Fair

Sure. So we do think that Cy/Flu is important to lead to better engraftment expansion of cells, which we think is necessary for a greater clinical activity. But we don’t think our efficacy optimize regimen will occur until we are using iMC as planned with repeat dosing of rimiducid.

So it’s a step along the way. We’ll present early results on both safety and activity and if there is an impact or show that of course, but I would be looking more towards late this year start seeing the impact of iMC and its efficacy optimize schedule.

Jim Birchenough

And maybe just one final one on 601, if you think about broader expression of PSCA, is there are any thought to doing a basket trial or you’re really capturing the main tumor types with prostate, gastric and pancreatic?

Rick Fair

No current plans to do a basket trial those three tumor types do capture the majority of PSCA-expressing tumor patient as far as we know. The literature on this is a little skinny so it’s possible there’s more PSCA expression other there than it has been published on, but we do think we’ve cover the majority of patients with those tumor.

Jim Birchenough

And maybe final somewhat related, but we’ve seen at least in last refractory gastric cancer several companies cut that and have to move earlier frontline because the patients progressive quickly. I think that’s pretty typical of pancreatic white line as well. So how do you think about migrating earlier and when might that happen in your development.

Rick Fair

Well, I think, this is -- Bill, our CMO is on the line, may want to comment, but just in anticipation to that. I think it’s typical of course to look for safety in early activity in beta line population. In our study we have moved up. So as I mentioned in the dose escalation phase we had very generous guidelines we had at late as sixth line pancreatic cancer patients which of course are very difficult to treat.

In our most recent modification we moved up the second line patients exclusively now partly for the reason that you cite. But certainly, we want to demonstrate some meaningful activity there before we started to compete with existing standards-of-care in frontline. Bill, do you have anything you want to add to that?

Bill Grossman

Yeah. I was going to add this, what you just said, Rick, we are trying to see have much more homogenous operation of patients for post [inaudible], gastric and HR acute prostate. So we are cognizant of that in that runway for having a therapy responses and look so we kind to address the amendment.

Jim Birchenough

Great. Well, thanks for taking the questions and congrats on all the progress.

Rick Fair

Thanks Jim. Appreciate it.

Operator

Thank you. Our next question comes from the line of Wangzhi Li from Ladenberg. You are now live.

Wangzhi Li

Hey. Thanks for taking my questions. Maybe starting with BPX-601, just to clarify really biopsy data to reported for the mid ‘19 and later ‘19 data report?

Rick Fair

Sorry, Wangzhi, could you repeat that question.

Wangzhi Li

So for BPX-60l data report initial at the mid ‘19, right, and…

Rick Fair

Yeah.

Wangzhi Li

… later in 2019.

Rick Fair

Yes.

Wangzhi Li

We see any biopsy data to see if the cell get into the tumor or the tissue?

Rick Fair

Yeah. It’s possible that we will -- we -- as you may know when we amended this trial to incorporate Cy/Flu and to add prostate and gastric patient eligibility. We did put in a requirement where it safe to do so to conduct on treatment biopsy. So it is possible that you’ll begin to see that data this year.

Wangzhi Li

Got it. Great. And then for the repeat -- rimiducid repeated dosing, any color on how frequent repeated dosing as thinking about or how many repeated dosing you’ll think about, I mean, any insights we have got you on this at this moment or any color?

Rick Fair

Yeah. So we have -- based on our evaluations preclinical we think a weekly schedule would make sense and dosing to progression or dosing limiting toxicity might make some sense, but of course, we want to engage the FDA in that discussions. So we’ll keep you posted as we modify that trial and where we land.

Wangzhi Li

Got it. Okay. And then for the dual switch HER2 CAR-T could share any information about the -- anything about or SDF we are using for your HER2 is the same with the [inaudible] HER2 CAR-T or is it proprietary different one?

Rick Fair

Maybe I’ll turn that question over to Aaron Foster, our Head of Research who is here with us he can talk about the construct.

Aaron Foster

Yeah. Sure. So the construct currently contains a modified version of tocilizumab antibody current called 45 but has mutations in it that lower the affinity to make it more selective for HER2 expressive tumors. This data was published earlier at the…

Wangzhi Li

Got it.

Aaron Foster

…group.

Wangzhi Li

This has embedded differentiation into the rimiducid and tumor and HER2 versus normal tissue HER2, the affinity or those kind of titrations?

Rick Fair

Sorry.

Rick Fair

He is asking does it recognize tumor HER2 better than…

Aaron Foster

Yeah. So we…

Rick Fair

… healthy tissue.

Aaron Foster

…right…

Rick Fair

…candidate.

Aaron Foster

Yeah. So we have done a number of experiments obviously in our preclinical data set looking at the specificity and reactivity of this binder compared to others. As previously observed in other studies we noticed that there is a decreased reactivity against low level antigen expression for HER2 with the modified binder.

In addition, we’ve done a lot of efficacy study comparing this binder to the previously plus others FRP 5, which is a mirroring binder that has been used in the beta study and it has significant the higher activity against the number of different tumor models.

So we think that this is a good fit for the program. Of course, in this construct we have two switches one to control the activation state, of course, used in iMC and again mitigating any tumor toxicity using Caspase-9 if needed.

Wangzhi Li

Got it. May final question is so for this are you targeting like a positive breast cancer, gastric cancer or any color on what kind of patient you’re going to treat for your Phase 1 trial initially?

Rick Fair

Sure. So, obviously, we want to have an IND approval and have FDA alignment on the design of the early trial, but it will certainly involve a dose escalation in a basket of HER2 expressing tumors and certainly in future phases we’ll be looking at early signals of activity in a variety of HER2 expressing tumors.

I don’t think breast is our lead choice given the crowd there and given the many, many alternative therapies there. But certainly other tumor types like light gastric, endometrial and others would be candidates for further development for this product.

Wangzhi Li

Great. Thanks for answering my questions.

Rick Fair

Thanks, Wangzhi.

Operator

Thank you. Our next question comes from the line of Peter Lawson from SunTrust Robinson Humphrey. You are now live.

Peter Lawson

Hey. Great. Thanks for taking all the questions. When do you expect to see the 601 trial amended, I guess, there is two amendments that need to be done?

Rick Fair

Well, the Cy/Flu amendment is done and implanted, the second amendment is the repeat rimiducid dosing. We expect to have that done by midyear.

Peter Lawson

Perfect. Okay. Thank you. And then what further re-dose should we expect for rivo-cel ahead of MIAA submission?

Rick Fair

I think our current plan would be to present the final analysis this year from the BP-004 study. We expect the topline on that in the second quarter. Given that timeline it’s unlikely we make DHA so we’re probably looking at ASH presentation, but we firm that up, that will depend on once we have data in hand.

Peter Lawson

Got you. Thank you. And then just on the -- how should we think about that data or when should we think about the data for the Phase 2/3 THRIVE study for U.S. and adults?

Rick Fair

Yeah. So you’ll recall the design of THRIVE has a Phase 2 running where we’re evaluating a higher dose 3 million cells per kilogram without GVHD prophylaxis in 10 patients to evaluate safety of that. We would expect to enroll all those patients and have long enough follow up to draw conclusions on that this year. As to when and where we’ll present those data to be determined, but we’ll have all that in 2019.

Peter Lawson

Great. Okay. Thanks for taking the questions.

Operator

Thank you. [Operator Instructions] Our next question comes from the line of Reni Benjamin from Raymond James. You are now live.

Reni Benjamin

Hey. Good afternoon, guys. Thanks for taking the questions. Rick, you mentioned that the final topline data is in the second quarter of 2019. What’s going to be materially different between what was presented at ASH versus now, about how many more patients and should we really expect any sort of material change in terms of efficacy or safety?

Rick Fair

Yeah. Thanks Reni for the question. We’ll have longer follow-up all of the patients will achieve the six-month EFS threshold in the BP-004 data set. And we will have the remaining patients accrued in the MUD, comparative MUD study C/CP-004.

But as you point out or imply in your question. Does these were late interim analyses that we presented at ASH that they have most of the information that will be in the final analysis so wouldn’t expect major changes in the outcomes, which is why we’ve expressed confidence that we have a viable data set at the final analysis.

Reni Benjamin

Right. Okay. And then switching gears to 601, you have a couple of patients that persists sort of greater than three weeks. You have cell expansion that tends to have a decent bit of variability between three- and 20-fold. Can you talk a little bit about what you’re learning in terms of how to bring those parameters maybe a little bit more in line to not have much variability do you need to and just kind of thoughts on what might be causing these differences between patients?

Rick Fair

Yeah. Maybe I’ll start by asking Aaron Foster to comment and then Bill Grossman if he has anything he wants to add can you do that?

Aaron Foster

Yeah. Sure. So I think one of the things that we’ve noticed and of course others in the field to have with their CAR-T cell products as they are coming from target source. The patient immune systems are variable and that there is some potentials to have variable performing products that come from these patients.

I think that by and large what we’ve seen as we looked at the product characterization profile during this transaction efficiencies and feeder type and things like that. And there has been a fair uniform batch a cell that we’ve made. We started looking deeper into the functionalities and we started to see some differences.

I think one point that’s we are interested in exploring is can repeated doses of rimiducid to activate iMC which overcomes some of these expansion differences and I think that’s what we’re hoping to see as we amend our clinical study.

Rick Fair

Bill anything you care to add to that.

Bill Grossman

I want to add expand on that actually would be that, this was also done as you know on under such toxic normally on the completion regimen which was as we recorded MOIO [ph] largely not lymphodepleting and majority of the patients and so that I think you also gave a lot of variability, as Aaron mentioned, as he point out. So I think once you get into the two side regimen we’ll see hopefully more reproducibility around the proliferation and expansion that we didn’t see with the Cytoxan and CAR-T patients.

Aaron Foster

Maybe once last point is that, we have extensive correlated studies that are taking place as we speak and continue to study and one aspect of course that we’re looking at is the expression level of PSCA and how that relates to CAR-T cell expansion. Other things like tumor burden and levels of once depletion can all contribute to differential performance both in fusion.

Reni Benjamin

Great. Thanks very much. Appreciate it.

Rick Fair

Thanks Reni.

Operator

Thank you. Ladies and gentlemen, we have no further questions in queue at this time. I’d like to turn the floor back over to management for closing.

Rick Fair

Thanks everyone for participating today as always I’d like to thank our passionate team at Bellicum, our collaborators and investigators for their efforts and most importantly the patients and families who participated in our clinical trials. They inspire our effort every day. Thanks and have a great evening.

Operator

Thank you, ladies and gentlemen. This does conclude our teleconference for today. You may now disconnect your lines at this time. Thank you for your participation and have a wonderful day.