Thomas J. Farrell - President and Chief Executive Officer Alan A. Musso - Chief Financial Officer and Treasurer Annemarie Moseley - Chief Operating Officer and Executive Vice President of Clinical Development

Tony Butler - Guggenheim Securities LLC

Good afternoon ladies and gentlemen, and thank you for standing by. Welcome to the Bellicum Pharmaceuticals Second Quarter Earnings Call and Mid-Year Review. At this time, all participants are in a listen-only mode. Later we will conduct a question-and-answer session and instructions will follow at that time. As a reminder, this conference will be recorded and available for replay. I would like to introduce your host for today, Alan Musso, Chief Financial Officer. Please go ahead. Alan A. Musso: Thank you, Nicole. Good afternoon everyone and thank you for joining the call. With me today are Tom Farrell, Bellicum's President and Chief Executive Officer and Annemarie Moseley, our Chief Operating Officer and Executive Vice President, Clinical Development. Earlier this afternoon Bellicum released financial results for the second quarter ended June 30, 2015. 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 Relation's page of the Company's website. Today's conference call will include forward-looking statements under the Private Securities Litigation Reform Act of 1995 including statements regarding our research and development plans and financial outlook. These forward-looking statements involve a number of risks and uncertainties and reflect our opinions only as 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 factor section of our form 10-K for the year ended December 31, 2014 and our report on Form 10-Q for the quarter ended June 30, 2015 filed with the Securities and Exchange Commission. And I'll now turn over the call to Tom. Thomas J. Farrell: Thank you, Alan and good afternoon everyone. Thank you for joining us. Our goal this afternoon is to provide an overview of the first half of 2015, review second quarter financial results and outline the key objectives for the remainder of the year and into 2016. After that, we look forward to answering your questions. I'm pleased to report that over the past six months we made substantial progress across all of our controlled cellular immunotherapy programs. In our lead BPX-501 clinical program, we're pleased with the strong pace of recruitment into our BP-004 trial evaluating pediatric patients with blood cancers or genetic blood disorders who receive an infusion of BPX-501 engineered T cells after T depleted haploidentical hematopoietic stem cell transplant. Annemarie will provide more detail shortly on the program's progress and why we believe BPX-501 could make our therapy known to be curative, safer, more effective and available to many more patients with a wide range of lifelong and deadly diseases. We also advanced our preclinical TCR and CAR-T products and we now expect to file INDs on two of our product candidates by the end of 2015. BPX-701 our TCR product candidate for solid tumors, expressing the PRAME antigen and BPX-601, our GoCAR-T product candidate for solid tumors overexpressing prostate stem cell antigen, or PSCA. We expect our third named preclinical candidate BPX-401 to enter the clinic in the first half of 2016. Meanwhile our discovery team continues to advance novel ways to enable control of the cells including the ability to activate, reduce or eliminate therapeutic cells. We believe our proprietary cellular control switches and our potential to provide greater levels of efficacy and safety will become increasingly important as the field evolves toward the treatment of solid tumors and additional antigen targets. Before I turn the call over to Annemarie to provide more details on our BPX-501 program, I'd like to point out that we've amended the BT-004 protocol to allow enrollment of 90 pediatric patients and we expect to disclose initial data on approximately 40 patients towards the end of this year. More specifically, the principal investigator for the BT-004 protocol, Dr. Franke-Locatelli, has submitted abstracts to the annual meeting of the American Society of Hematology to be held in Orlando in early December. And with that, I'll turn the call over to Annemarie.

Thank you, Tom. I'd like to take a step back and talk about the goals of our BPX-501 program and what we're looking for in terms of safety and efficacy. Hematopoietic stem cell transplant is a curative treatment and is a standard for many cancers and many genetic blood diseases, but unless you have a matched donor the procedure can be risky and most physicians choose to not to recommend it until the patient has run out of safer treatment options. In contrast a haplo donor which is a half match with a first-degree relative such as a sibling, parent or child, can almost always be identified as a donor. However, haplo-transplants to date have not been widely adopted due to the concern of two major risks, GvHD and infections. First, if the haplo-transplant contains T cells which are important for rebuilding immunity and infection control, there is a high risk of developing GvHD. For that reason, a transplant procedure is either completely avoided, which has historically been the case or if the haplo-transplant is performed the T cells are first depleted or removed from the graft. However, in a T depleted transplant while there is a lower risk of GvHD, morbidity and mortality rates are still high as a result of infections, slow engraftment and delayed immune recovery due to the lack of the T cells. To address these issues in the haplo setting, we've developed BPX-501, an adjunct cellular therapy of genetically modified T cells which incorporate a proprietary clinically validated CaspaCIDe safety switch. The product is designed to provide a safety net so that physicians can perform haplo stem cell transplants and add back the important T cells to speed immune reconstitution and control infections. Currently the BPX-501 clinical program spans a number of trial protocols in adults and children for both malignant and nonmalignant disorders, specifically in the pediatric BT-004 trial where much of our efforts have been focused recently. T cells are depleted from donor stem cells and these are often the parents who are donors, engineered with our safety switch and then infused to the patient generally within 14 days of the transplant. The goal of our trials is to provide better overall transplant outcomes, lower rates of infection and faster immune recovery than one would generally expect from an alternative allogeneic transplant procedure such as a haplo-transplant. Several published studies have supported this view including the DOTTI study published in BLOOD in May that showed that infusing haplo-identical donor T cells with the CaspaCIDe safety switch following a T depleted haplo-transplant led to improved immune reconstitution and infection control. The study demonstrated that when GvHD did occur it was rapidly controlled and eliminated by removing alloreactive cells in vivo with a single dose of rimiducid and that the productive antiviral and anticancer cells remain and repopulate and maintain immunity in those patients. As Tom mentioned, we are pleased with the strong recruitment into the BT-004 trial and excited to be working with leading pediatric child centers in Europe and U.S. To date approximately one half of the patients enrolled have a genetic blood disease and the other half are being treated for blood cancer. With that, I'm going to turn the call back over to Tom. Thomas J. Farrell: Thank you, Annemarie. If BPX-501 is successful, it has the potential to greatly expand the number of haploidentical transplant procedures for many diseases including leukemias, lymphomas and genetic blood diseases such as severe combined immunodeficiency or SCID, Wiskott-Aldrich Syndrome and beta thalassemia to name a few. We're particularly excited to be working towards enabling a curative treatment option for children who might not otherwise reach adulthood. In other developments, in July the intellectual property of BPX-501 was strengthened with a U.S. method of use patent issued to Baylor College of Medicine. The patent licensed exclusively to Bellicum is scheduled to expire in 2031. Looking at the rest of our pipeline, I am pleased to report that we're making good progress moving out TCR and CAR-T products towards the clinic. We have identified clinical sites for our BPX-701, classified enabled TCR study and we expect to file an IND for this program by the end of 2015. We're planning to initially develop this product candidate for the indications of PRAME-expressing sarcomas and uveal melanoma a rare orphan disease. BPX-601 GoCAR-T product candidate is progressing at schedule with work ongoing to facilitate an IND filing for full year end. We're excited about the potential of BPX-601 and delighted with the acceleration of the timeline from our prior guidance which was to enter clinical trials in the second half of 2016. The product candidate incorporates the GoCAR-T activation switch and is designed to treat solid tumors expressing the prostate stem cell antigen, or PSCA such as some pancreatic prostate, bladder, esophageal and gastric cancers. We expect the initial clinical trial for BPX-601 will be in pancreatic cancer. BPX-401 a CIDeCAR product candidate constructed with Bellicum’s proprietary MyD88 and CD40 or MC co-stimulatory domain and the CaspaCIDe safety switch, is on track to enter Phase 1/2 clinical trials in the first half of 2016 for the treatment of blood cancers expressing CD19, including acute lymphocytic leukemia, chronic lymphocytic leukemia, and certain non-Hodgkin’s lymphomas. We presented data at ASCO this summer highlighting the potent anti-tumor effects of our CIDeCAR constructs. We reported results and are close to presentation of two preclinical studies that evaluated its tumor killing abilities showing that MC co-stimulation increased T cell proliferation and enhanced efficacy in both lymphoma and solid tumor models in vivo compared to CAR T cells that included the more commonly utilized co-stimulatory molecule CD28. In a lymphoma model BPX-401 elicited dose dependent elevation of cytokines, analogous to cytokine release syndrome, but cytokine levels were rapidly normalized upon administration of rimiducid, safely and without loss of tumor control. These outcomes suggested our CIDeCAR product candidates including BPX-401 may safely deliver a more potent therapy in bulky lymphomas and solid tumors. Turning to BPX-201 we have made the decision to discontinue further development of this program after the ongoing Phase 1 study concludes. We continue to believe there is scientific merit in evaluating BPX-201 in combination with a checkpoint inhibitor which was the planned next step to this program. However, based on the acceleration of our BPX-601 program and its applicability to prostate cancer, we conclude that the further development of BPX-201 would not be the best use of our resources. On the corporate front, we continue to strengthen our leadership team and board having long time industry veteran Steve Davis to our Board of Directors making key executive hires in the areas of commercialization, product development and human resources. We have also identified and leased space for the planned build out of our facilities to enable in-house cell therapy manufacturing with clinical studies. At this point, I'll turn the call over to Alan to review our second quarter financials. Alan A. Musso: Thanks, Tom. Bellicum reported a net loss of $10.5 million for the second quarter of 2015 and $18.3 million for the six months ended June 30, 2015, compared to a net loss of $3.3 million and $5.6 million for the comparable periods in 2014. The results included non-cash, stock-based compensation charges of $2.1 million and $3.6 million for the second quarter and six months ended June 30, 2015 and $0.1 million and $0.2 million for the comparable periods in 2014. As of June 30, 2015, cash and investments totaled $172.6 million. Grant revenues were $0.1 million and $0.2 million for the three and six months ended June 30, 2015, respectively, and $0.6 million and $1.1 million during the comparable periods in 2014. The decrease in grant revenues was primarily due to the June 2014 expiration of our grant award from the Cancer Prevention and Research Institute of Texas. Research and development expenses in the second quarter of 2015 were $8.0 million and $13.7 million for the six months ended June 30, 2015, compared to $3.2 million and $5.6 million during the comparable periods in 2014. The higher expenses in the 2015 periods were primarily due to an increase in manufacturing and clinical expenses as a result of increased patient enrollment in our BPX-501 clinical trials, increased expenses for the IND enabling activities on our CAR-T and TCR product candidates and increased personnel and infrastructure costs. General and administrative expenses in the second quarter of 2015 were $2.8 million and $5.0 million for the six months ended June 30, 2015, compared to $0.6 million and $1.0 million during the comparable periods in 2014. The increased G&A expenses were due to the growth of the organization and costs associated with operating as a public company. I'd now like to turn the call back to Tom. Thomas J. Farrell: Great, thanks Alan. So as you've heard today, 2015 is shaping out to be an exciting and productive year for Bellicum. I'm very pleased with the progress of our lead BPX-501 clinical program and the prospects of seeing initial clinical data from the ongoing European and U.S. pediatric study in December. We're also busy preparing for the filing our INDs for our first TCR product candidate BPX-701 and our first GoCAR-T product candidate BPX-601 by year end. Our scientific teams continue to innovate and are evaluating additional antigen targets, novel molecular switches and approaches to off the shelf delivery of cellular immunotherapies. We expect to move additional differentiated control program in the therapies into the clinic in 2016 and beyond. There is certainly plenty of work ahead, but our leadership team and all of our employees are excited and motivated to keep advancing our pipeline of potentially breakthrough therapies for patients who so desperately need them. Thank you for joining us on today's call and now we're happy to take your questions.

Thank you. [Operator Instructions] Our first question comes from [indiscernible] of Citi. Your line is now open.

Hi this is Ken. Thanks for taking my question. I was hoping you might be able to talk a little bit about the decision to upsize the BP-004 trial for BPX-501. Is this due to more then expected incidents of GvHD there?

Hi Ken, this is Annemarie. Actually the reason is that the original trial arm in Europe of 30 patients was reaching completion and we needed to create more capacity based on the interest from the various centers in enrolling.

Got you, okay perfect. And then, next congrats on the progress of BPX-601. I was wondering if you could talk a little bit more about the sort of preclinical package there that was required by the FDA and sort of what enabled the rapid advancement there in timelines for the product? Thomas J. Farrell: Yes, I think there are a couple of factors there Ken and first of all we recognized at the time of the IPO that we had, we deliberately upsized the round which gave us additional bandwidth to pursue certain programs more aggressively. We have been busy hiring this year. We are now up to close to 60 employees in the time in the company and a lot of those new hires are focused on clinical trial readiness. So that's on the one hand, on the other hand we have been continuing to build our understanding of BPX-601 in animal models. We have not released any new data since December, but essentially we've got increasingly comfortable with our ability to control these GoCAR-T cells. And as you know, instead of having a safety switch, an active safety switch or a brake in the cell we have a gas pedal which is controlled by the scheduled administration of rimiducid. And so we have become increasingly comfortable and we have the ability to dial up the activity in a very measured fashion and that we have essentially approaches to evaluating that in patient's that are supported by the data that we're developing. So I think it is progress on a couple of fronts and of course it's the one of the programs that we have been working on is probably the most innovative and different from what had been done in the past. And so we had always in thinking about where might we want to move things quicker, that's where our attention was drawn.

Great, thank you.

[Operator Instructions] Our next question comes from Tony Butler of Guggenheim Partners. Your line is now open.

Yes, thanks very much. Two questions Annemarie, one is on 004 in patients who actually may have alloreactive T cells which are from the donor, the question is why might engraftment not occur in that particular recipient? And then a second question a little bit broader, again similar in 004, what would the FDA or what would you think the FDA would want to see as a registration trial size and the appropriate type of endpoints? Thanks very much.

Thank you, Tony. So I'm going to answer the first question on order that when patients have alloreactive T cells in the graft it really depends a little bit on their quantity. If they are completely overwhelming in an unmanipulated haplo setting, that is the grafted is unmanipulated, then clearly those T cells could completely affect the overall ability of the graft to engraft and also to cause overwhelming GvH. But generally the T cells in the graft don’t affect engraftment as much as the T cells in the host. So I think from that standpoint it is really more in terms of support of the stem cells that you want to leave T cells behind or add T cells back which are just a little bit to be able to fight any residual host T cells that might be there after the conditioning. The engraftment is a very fine balance between conditioning and that which includes both drugs and possibly radiation as well as then a balance of the T cells in the graft. So in this case again the goal is to remove the alloreactive T cells and add back a limited amount that we then hope will be safe course for the patient in that setting. As to your second question, as you know, we've said that we are going to be working with both U.S. and European regulators after the beginning of next year, the first half of next year on what our requirements are going to be for registration trials or registration in general. At that point we will have a package of data for them. There is certainly precedent for orphan and rare diseases for sort of a single arm studies, but also more commonly randomized control trials are the norm for certain indications as well. So at this point what we can say is that we are still on target to talk to the regulators that we are really very hopeful for some very aggressive discussions and strategies. And so we'll certainly hope to have more information for you at that time.

Thank you.

Thank you. [Operator Instructions] And I am showing no further questions at this time. I'd like to hand the call back over to Mr. Tom Farrell for any closing remarks. Thomas J. Farrell: Great, thank you very much and thank you for the questions. Before you wrap up I'd like to acknowledge our employees for their continued hard work and dedication and our shareholders for their continued interest and support. So thank you again for participating on today's call and have a great evening.

Ladies and gentlemen, thank you for participating in today's conference. That does conclude today's program. You may all disconnect. Have a great day everyone.