Scott Wolchko - President and CEO Dr. Chris Storgard - Chief Medical Officer Dr. Dan Shoemaker - Chief Scientific Officer.

David Nierengarten - Wedbush Securities Do Kim - BMO Capital Markets Ren Benjamin - Raymond James.

Welcome to Fate Therapeutics Second Quarter 2017 Financial Results Conference Call. At this time, all participants are in a listen-only mode. This call is being webcast live on the Investors & Media section of Fate’s website at fatetherapeutics.com. As a reminder, today’s call is being recorded.

I would now like to introduce Scott Wolchko, President and Chief Executive Officer of Fate Therapeutics..

Thank you. Good afternoon and thanks everyone for joining us for the Fate Therapeutics second quarter 2017 financial results call. Shortly after 4 pm Eastern Time today, we issued a press release with these results, which can be found on the Investors & Media section of our website under Press Releases.

In addition, our Form 10-Q for the second quarter ended June 30, 2017 was filed shortly thereafter and can be found on the Investors & Media section of our website under Financial Information.

Before we begin, I would like to remind everyone that except for statements of historical facts, the statements made by management and responses to questions on this conference call are forward-looking statements under the Safe Harbor provisions of the Private Securities Litigation Reform Act of 1995.

These statements involve risks and uncertainties that can cause actual results to differ materially from those in such forward-looking statements.

Please see the forward-looking statement disclaimer on the Company’s earnings press release issued after the close of market today, as well as the risk factors in the Company’s SEC filings, included in our Form 10-Q for the second quarter ended June 30, 2017 that was filed with the SEC today.

Undue reliance should not be placed on forward-looking statements which speak only as of the date they are made, as the facts and circumstances underlying these forward-looking statements may change.

Except as required by law, Fate Therapeutics disclaims any obligation to update these forward-looking statements to reflect future information, events, or circumstances. Joining me on the call today are Dr. Chris Storgard, our Chief Medical Officer; and Dr. Dan Shoemaker, our Chief Scientific Officer.

I will begin the call by highlighting our clinical progress and development strategy for FATE-NK100, our first-in-class adaptive memory natural killer cell product for the treatment of advanced hematologic and solid tumor malignancies.

I will also discuss the therapeutic opportunities for ProTmune, our next generation cell graft for the prevention of acute graft-versus-host disease.

Chris will then provide an update on our PROTECT study an ongoing combined Phase 1/2 clinical study of ProTmune in adult subjects with hematologic malignancies where we have convened the study’s Data Monitoring Committee to review Phase 1 data and seek its recommendation regarding advancement into the Phase 2 efficacy stage.

Dan will then discuss our proprietary induced pluripotent stem cell or iPSC product platform and our off-the-shelf cancer immunotherapy product candidates emerging from this platform.

We currently remain on track to file in the first quarter of 2018, an investigational new drug application with the FDA for the conduct of a landmark clinical trial with an off-the-shelf cancer immunotherapy derived from a master pluripotent cell line.

And I will conclude with the review of our financial results for the second quarter 2017 before opening the call upto questions and further discussion. Over the past several months, I am pleased to report that we have achieved several key clinical milestones with each of our clinical-stage product candidates.

So, ProTmune, our next generation cell graft for the prevention of acute graft-versus-host disease, we can now share that the first six subjects in the Phase 1 safety stage of PROTECT have received ProTmune.

In accordance with the PROTECT Phase 1 clinical protocol, we have convened the study’s independent Data Monitoring Committee to resume the Phase 1 data and to seek its recommendation regarding advancement into the Phase 2 efficacy stage.

Following the committee’s review, we expect to report PROTECT’s Phase 1 safety data and open Phase 2 for enrollment, next month. For FATE-NK100, our first-in-class adaptive memory nature killer cell product, I’m pleased to report several exciting developments.

The first subject has been treated with FATE-NK100 in the VOYAGE study for refractory or relapsed AML. In addition, the FDA has now authorized the conduct of two additional clinical trials of FATE-NK100 under separate investigational new drug applications.

We’re preparing for the launch of the APOLLO study for the treatment of refractory or recurrent ovarian cancer and the DIMENSION study for the treatment of advanced solid tumors in combination with monoclonal antibody therapy.

As a reminder, FATE-NK100 is first-in-class natural killer cell cancer immunotherapy comprised of adaptive memory NK cells, a highly specialized and functionally distinct subset of activated NK cells expressing the maturing markers CD57 and the memory-like activating receptor NKG2C.

Fate Therapeutics in collaboration with the University of Minnesota is the first group to generate therapeutically relevant quantities of this subset of NK cells, which we’ve shown have enhanced effector functions and focusing preclinical studies.

This has enabled for the first time, this effector cell type to be generated from healthy donor cells and to be delivered to patients as a therapy for the treatment of cancer.

Over the past several months, we have had the opportunity to speak with a diverse group of cancer immunotherapy investigators who indicated there is a broad enthusiasm to participate in the clinical investigation of FATE-NK100.

There is also unqualified recognition that FATE-NK100 is comprised of a highly differentiated effector cell types with broad therapeutic potential across the cancer immunotherapy field including use in combination with checkpoint inhibitors and monoclonal antibody therapy.

Finally, there is a clear consensus that the first three clinical trials of FATE-NK100 are well-suited to demonstrate its unique therapeutic potential. I would like to expand on this last point in more detail.

We’ve chosen to initially clinical development of FATE-NK100 in refractory or relapsed AML, in refractory or recurrent ovarian cancer, and advanced solid tumor malignancies in combination with monoclonal antibodies therapy. Each of these three specific studies of cancer was targeted with deliberate intent.

We’re focused on cancers where we believe NK cell therapy is biologically advantaged where we can potentially drive a multifaceted potent and durable immunological response where we have the potential to demonstrate proof-of-concept and therapeutic differentiation in a small number of subjects and where we believe early clinical success can translate into rapid registration studies.

In AML, patients who are refractory to frontline therapy or relapse, have a very poor prognosis and few treatment options. Endogenous NK cells in these patients are often dysfunctional and reduced in number.

Several recent clinical studies have shown that adoptive transfer of NK cells from healthy donors to patients can selectively target and destroy leukemic blasts without causing graft-versus-host disease or triggering significant side effects such as cytokine release syndrome.

For example, several medical groups have recently reported 25% to 30% complete response rates with donor NK cell therapy in refractory or relapsed AML. In ovarian cancer, standard therapies for women with refractory or recurrent ovarian cancer provide very poor clinical outcomes.

Additionally, single arm studies in second line therapy have shown that objective response rates in patients with measurable disease are as low as 10% to 35%. There remains a critical need for novel therapeutic strategies as current rates of progression-free survival are less than six months.

The APOLLO study is designed to deliver FATE-NK100 directly into the peritoneum in an outpatient setting. We believe this approach affords several distinct advantages that may translate into significant therapeutic benefit.

Number one, we have directly co-localized FATE-NK100 with ovarian tumor cells, avoiding the need for peripheral infusion and effector cell trafficking while maximizing the opportunity for NK cell persistence.

Number two, a significant majority of tumor cells found in ovarian carcinoma expressed stress ligands which have been shown to be robustly detected by activating receptors down on FATE-NK100.

And number three, since we’re substantially reducing the conditioning regimen, we believe that the enhanced levels of pro-inflammatory signals secreted by FATE-NK100 upon tumor cell engagement, can stimulate and recruit a long-lived polyclonal endogenous T-cell response.

Finally, in advanced solid tumors in combination with monoclonal antibody therapy, our DIMENSION study targets subjects that have progressed on or failed FDA approved monoclonal antibody therapy.

These therapies include herceptin for advanced HER2 positive cancers including breast and gastric, and erbitux for advanced EGFR1 positive cancers including colorectal and head and neck.

It has been shown that NK cells are the key effector cells mediating antibody dependant cellular cytotoxicity or ADCC, which occurs when NK cells synergize with monoclonal antibodies to live [ph] tumor cells.

Similar to our APOLLO study, subjects in DIMENSION will receive outpatient therapy which we believe will allow for the triggering of a long-lived adaptive T-cell immune response.

To our knowledge, our planned study in this setting is the first authorization by the FDA, so the clinical investigation of allogeneic NK cells in combination with these monoclonal antibody therapies.

Looking ahead, with the treatment of our first subject with FATE-NK100 in VOYAGE and the separate IND clearances for conduct of APOLLO and DIMENSION, our clinical focus at Fate Therapeutics is on driving subject enrollment and increasing the number of clinical sites opened for subject enrollment.

We’re engaged with six sites in addition to the University of Minnesota that have the capacity and the interest to participate in each of the three FATE-NK100 studies. We expect to begin sharing initial clinical data from these FATE-NK100 studies at a scientific conference during the second half of 2017.

I would like to take a few minutes now and discuss the therapeutic opportunity for ProTmune. ProTmune is being developed as a next generation donor cell graft for patients undergoing allogeneic hematopoietic cell transplant.

Approximately 30,000 allogeneic transplants are performed each year, with over 80% performed in adults for the treatment of hematologic malignancies, most commonly AML, ALL and MDS. For these patients, allogeneic transplant is performed with curative intent.

In fact, for those patients that are alive and cancer-free two years following transplant, the probability for 10-year cancer-free survival is exceptional at over 80%. This survival rate is unprecedented and underscores the profound potential of allogeneic transplant to cure patients stricken with even the most fatal blood cancers.

It is well accepted throughout the clinical community that the curative potential of allogeneic transplant is optimized through the use of donor cells that are matched to the patient’s tissue type. Fortunately, most patients likely to benefit from transplant having matched donor either from a matched sibling or from a matched unrelated donor or URD.

And the potential to find a matched URD continues to grow each year through the help of national donor registries such as Be The Match in United States. As of 2015, over 25 million people worldwide were listed in registries as potential volunteer donors for patients undergoing transplant.

Our initial development strategy for ProTmune is directed towards this segment of allogeneic transplant, specifically patients with a matched unrelated donor for the treatment of hematologic malignancies including AML, ALL and MDS.

Importantly, this is the most prevalent segment, representing more than half of all allogeneic transplants conducted in the U.S. each year.

As such, our focus on matched unrelated donor transplant, for the treatment of hematologic malignancies affords patient access, transplant protocols that have been uniformly established as standard of care, and well-characterized clinical outcomes that have been consistently observed.

While long-term curative rates are high for patients achieving disease-free survival of two years, patients unfortunately face a multitude of life-threatening complications during the first days and months following transplant.

In fact, approximately 25% to 30% of patients die during the first six months following transplant, and the mortality rate rises to over 40% at one year where the leading causes of mortality are relapse, graft-versus-host disease and infections.

Our focus in developing ProTmune is on acute graft-versus-host disease or GVHD, which is one of the leading causes of early morbidity and mortality, post-transplant.

Acute GVHD is a sever immunological disease that commonly arrives in patients during the first weeks following allogeneic transplant when the newly transplanted donor immune cells attack the patient’s tissues and organs, resulting in a potentially fatal immune system reaction.

Prospective clinical studies have shown that 40% to 80% of patients undergoing matched unrelated donor transplants experienced acute GVHD with most incidents occurring by day 60, post-transplant, despite the use of standard prophylaxis regimens.

As ProTmune is a next generation cell graft, our therapeutic approach towards a acute GVHD is prevented rather than treatment upon disease occurrence.

The prevention of acute GVHD is of paramount importance, since treatments are effective in only about half of affected patients and are associated with increases in cancer relapse and severe infections.

In fact acute GVHD is the leading cause of growing morbidity and mortality in matched unrelated donor transplant where death directly attributable to acute GVHD or its treatment occurs in 10% to 20% of patients. There are currently no approved preventative therapies in the U.S. for acute GVHD. There is substantial unmet need.

While ProTmune’s therapeutic paradigm is preventative, we expect that mild cases of acute GVHD may still occur, given prospective clinical studies have shown very high incidents after matched unrelated donor transplant. Our therapeutic objective is to demonstrate a significant reduction in the incidents in severity of GVHD events with ProTmune.

This expectation is consistent with our Fast Track designation for ProTmune which is for the reduction of incidence and severity of acute GVHD.

We are currently conducting an ongoing Phase 1 open-label Phase 2 blinded and randomized controlled clinical trial of ProTmune in adult subjects with hematologic malignancies undergoing matched unrelated donor transplant, a study which we refer to as PROTECT. Six subjects have received ProTmune in the Phase 1 safety stage of PROTECT.

ProTmune has been well-tolerated and we are encouraged by the early safety profile to-date. I’ll now turn the call over to Dr. Chris Storgard, our Chief Medical Officer, who will provide more detail on the PROTECT study and our road to the ASH annual meeting in December 2017 with ProTmune..

Thanks, Scott. As Scott mentioned, PROTECT is a two-stage clinical study. The Phase 1 stage of PROTECT is assessing the safety of ProTmune as measured by incidents of engraftment and survival by day 28 post-transplant. As a next generation cell graft, ProTmune is the sole source of cell for reconstitution of the patient’s blood in immune system.

ProTmune is not an adjunctive therapy used in combination with allogeneic transplant. ProTmune is the cell graft. This is an important difference when compared to other approaches that are being explored for acute GVHD.

As the cell graft, it is essential that ProTmune demonstrate high grades of engraftment without failure and early survival in the Phase 1 safety stage of PROTECT. Large registry base [ph] has shown that in patients undergoing matched unrelated donor transplant,.

the day 30 engraftment rate is over 95% with a median time to engraftment of 16 days and the day 30 survival rate is over 90%. Six subjects have received ProTmune at four clinical sites in the Phase 1 safety stage of PROTECT.

The underlying hematologic diseases include the three subjects with acute lymphoblastic leukemia, two with acute myeloid leukemia and one with myelodysplastic syndrome. As Scott mentioned, we are very encouraged by the safety profile to date. ProTmune has been well tolerated with no reported ProTmune-related serious adverse events.

As per the Phase 1 stage of the clinical protocol, after six subjects have been dosed and evaluated for up to 28 days, and five or more of these six subjects have engrafted by day 28, then the enrollment in the Phase 2 stage of the study may proceed following review by the study’s Data Monitoring Committee.

Now, in accordance with this, we have scheduled the study’s independent Data Monitoring Committee to review the Phase 1 data and we seek its recommendation for advancement into the randomized, controlled and blinded Phase 2 efficacy stage.

Promptly following the completion of the committee’s review, we expect to report PROTECT Phase 1 safety data including both neutrophil engraftment and survival. In addition to assessing safety, the Phase 1 stage of PROTECT will assess the incidence of acute GVHD by day 100.

Because acute GVHD events typically occur early and often, the Phase 1 stage has the potential to demonstrate early clinical proof of concept. Prospective clinical studies have shown that 40% to up to 80% of patients undergoing a matched unrelated donor transplant experience acute GVHD despite the use of standard prophylaxis regimens.

We have submitted an abstract for presentation of the PROTECT Phase 1 data at the American Society of Hematology annual meeting to be held in December 2017. At this meeting, we plan to report further safety data as well as the day 100 acute GVHD data for all Phase 1 subjects.

And while the PROTECT study’s Data Monitoring Committee is reviewing the Phase 1 data, we continue to prepare for the launch of the randomized controls in blinded Phase 2 efficacy stage of PROTECT.

The primary endpoint of the Phase 2 stage is the incidence of grade B through D acute graft-versus-host disease by day 100, where the ProTmune cell graft will be compared to a standard of care match unrelated donor cell graft.

In the Phase 2 stage, we will plan to continue to follow subjects beyond Day 100 to continue to demonstrate safety including showing that ProTmune is an immunologically active graft. We plan to open enrollment into the randomized, controlled and blinded Phase 2 efficacy stage of PROTECT next month. 12 U.S.

centers are currently prepared for enrollment and we are working to activate an additional four to six centers by the end of 2017. In closing and as a reminder, the FDA has granted fast track designation for ProTmune for the reduction of incidence and severity of acute graft-versus-host disease in patients undergoing allogeneic transplant.

As such, we are confident that a significant reduction in the incidence of acute GVHD by day 100 is the primary endpoint that supports registration. I’ll now turn the call over to Dr. Dan Shoemaker, our Chief Scientific Officer, who will provide more detail on our advanced preclinical off-the-shelf cancer immunotherapy pipeline..

Thanks, Chris. I’ll now provide an update on our NK cell cancer immunotherapy pipeline. First, we co-authored the manuscript with researchers at the University of Minnesota that was just published in the peer reviewed Journal of Cancer Research where we described the unique antitumor properties of FATE-NK100.

The published data show that FATE-NK100 exhibits greater natural cytotoxicity, cytokine production and ADCC activity against the variety of cancer cell lines compared to conventional NK cells derived from peripheral blood. In addition, FATE-NK100 was shown to have enhanced antitumor activity xenogeneic model of ovarian cancer.

These exciting preclinical findings have paved the way for our clinical investigation of FATE-NK100.

Next, at the annual meeting of the International Society for Stem Cell Research in June, we hosted a Focus Session entitled Off-the-Shelf Natural Killer Cell Cancer Immunotherapy, which featured presentations by our collaborators including Jeff Miller from the University of Minnesota; Karl-Johan Malmberg from Oslo University; and Dan Kaufman from UCSD.

The session highlighted our significant progress in advancing our pluripotent stem cell or iPSC product platform and our off-the-shelf cancer immunotherapy product candidates.

Similar to master cell lines used for the manufacture of therapeutic antibodies, our platform enables the creation of master pluripotent cell lines which have the potential to serve as a renewable source for the consistent manufacture of clonal populations of effector cells that are homogeneous and well-defined, can be dose titrated and delivered in multi-dose regimens and can be readily distributed to thousands of patients in an off-the-shelf manner.

We presented our preclinical findings for FT500i, our first NK cell product candidate derived from a master pluripotent cell line. FT500i is being developed as an off-the-shelf multi-dose cancer immunotherapy for use in combination with checkpoint inhibitors.

Preclinical data indicates that FT500i has enhanced cytotoxicity and cytokine production against a variety of cancer cell lines compared to conventional NK cells, along with robust antitumor activity xenogeneic mouse models.

Additionally, the resilience of FT500i cryopreservation, which is critical to enable central manufacturing and off-the-shelf delivery was presented showing greater than 85% viability following cryopreservation.

Importantly, an infusible media formulation is used for cryopreservation which enables FT500i to be brought and directly infused in the patients without requiring additional product processing and handling. We also presented preclinical data for FT516i, our second iPSC-derived NK cell product candidate.

FT516i is arrived from a clonal iPSC line engineered to express a high-affinity, non-cleavable CD16 Fc receptor. Preclinical data showed that FT516i is compressed of a uniform population of NK cells expressing this receptor.

FT516i cells were shown to be phenotypically mature and highly functional in vitro and to exhibit enhanced ADCC activity when combined with monoclonal antibodies. Importantly in contrast to peripheral blood derived and cord blood derived NK cells, FT516i cells proves to be resistant to activation induced surface cleavage of CD16.

As expected, the combination of FT516i cells and anti-CD20 antibody as compared to anti-CD20 antibody treatment alone, demonstrated improved tumor regression and improved survival in vivo in preclinical studies.

Similar results were also observed with the combination of FT516i and anti-HER2 and anti-EGFR antibodies in ovarian cancer, lung carcinoma and pancreatic cancer mouse models. We also featured a progress in optimizing chimeric antigen receptor constructs for NK cells.

For example, we highlighted a specific construct continuing the transmembrane domain of NKG2D, the 2-B4 co-stimulatory domain and the CD3 zeta signaling domain, which was shown to be a preferred configuration for NK cell biology.

Interestingly, NK cells arrive from a pluripotent cell line engineered with this preferred CAR construct were shown to have improved killing of target expressing tumor cells as compared to NK cells derived from a pluripotent cell line engineered with a third generation CAR construct optimized for T cell biology.

Finally, I am pleased to report several key advancements that we’ve made on our use of master pluripotent cell lines to manufacture iPSC-derived NK cells. Based on our pre-IND meeting with FDA this past spring, we knew that detecting residual iPSCs in the final NK sub drug product would be a critical part of our preclinical safety packets.

To address this issue, we developed a highly sensitive detection assay for residual iPSC detection. Specifically, we identified a key gene signature that is highly expressed in induce pluripotent stem cells but is not expressed in NK cells.

Validation results of this assay have shown that in a background of greater than 1 million NK cells, we have the resolution to detect a single iPSC when spiked in the culture.

Using this highly sensitive detection assay, we’ve demonstrated in multiple pilot scale manufacturing runs that our NK cell drug product does not contain any residual iPSC to that highest revolution level of our detection.

We continue to work with molecular and cellular therapeutics, a state of the art GMP compliant facility at the University of Minnesota to establish clinical scale manufacturer for FT500i to support first in human studies.

At this time, we remain on track to submit to the FDA what we believe will be the first IND application for a cancer immunotherapy to arrive from a master pluripotent cell line in the first quarter of 2018. I’ll now turn the call back over to Scott for a review of our second quarter 2017 financial results..

Thanks Dan. Turning to our financial results for the second quarter ended June 30, 2017, Fate Therapeutics reported a net loss of $9.6 million or $0.23 per common share as compared to a net loss of $8.4 million or $0.29 per common share for the same period last year.

Revenue was $1 million for the second quarter of 2017 as well as for the second quarter of 2016. Revenue in both periods was generated from our strategic research collaboration with Juno Therapeutics. Research and development expenses for the second quarter of 2017 were $7.9 million compared to $6.8 million for the same period last year.

The increase was primarily related to an increase in third-party service provider fees to support the clinical development of ProTmune and FATE-NK100 and a preclinical advancement of the Company’s off-the-shelf iPS derived cellular immunotherapy programs, and in facility costs associated with the expansion of the Company’s laboratory space.

G&A expenses for the second quarter of 2017 were $2.7 million compared to $2.2 million for the same period last year. This increase was primarily related to an increase in intellectual property related expenses.

After adjusting for research funding proceeds from Juno of $500,000 and for stock-based compensation expense of approximately $1 million, total operating expenses for the second quarter of 2017 were $9.1 million. At the end of the second quarter of 2017, cash, cash equivalents and short-term investments were $71 million.

Including the $7.5 million in net cash proceeds from our July 2017 debt financing with Silicon Valley Bank, pro forma cash, cash equivalents and short-term investments were $78.5 million.

Common stock outstanding was approximately 41.4 million and preferred convertible stock outstanding was approximately 2.8 million shares, each of which is convertible into five shares of common stock under certain conditions.

Looking ahead, for FATE-NK100, our focus is on driving subject enrollment and increasing the number of clinical sites opened for subject enrollment in VOYAGE and on opening enrollment APOLLO and DIMENSION at these clinical sites and treating our first subjects in these studies.

We expect to begin sharing initial clinical data from these open label studies of FATE-NK100 at scientific conferences during the second half of 2017.

For ProTmune, we can be in the PROTECT independent Data Monitoring Committee to review all available Phase 1 data and to seek its recommendation for advancement into the randomized control and blinded Phase 2 efficacy stage.

Promptly following the completion of the committees review, we expect to report PPROTECT Phase 1 safety data, including both neutrophil engraftment and survival, and to open enrollment into the randomized controlled and blinded Phase 2 efficacy stage of PROTECT, next month.

We also plan to present PROTECT Phase 1 data including the incidents and severity of acute GVHD for all Phase 1 subjects at ASH in December 2017. For FT500i and FT516i, we will continue to feature these product candidates and our off-the-shelf cancer immunotherapy product pipeline at several scientific conferences throughout the second half of 2017.

And we look forward to continue our discussions with the FDA as we drive to become the first Company ever to advance the cancer immunotherapy created from a master pluripotent cell line to clinical development. We remain on track to file our IND application with the FDA during the first quarter of 2018.

And with that, I’d like to turn the call over to the operator for any questions..

Thank you [Operator Instructions] Our first question comes from the line of David Nierengarten of Wedbush Securities.

Your question, please?.

Hey, thanks for taking the question. First off on the PROTECT study and the Data Monitoring Committee.

I mean, what additional data or patient data are they going over, since it seems that you of course are proceeding along with the next phase of the study, which seems that they have -- it would seem that they have already made the decision to be perfectly honest. So, what more needs to be done or when could you share perhaps some of the early data..

Sure. And Chris -- I’ll turn this over to Chris. We have convened the meeting; the meeting has not taken place yet. We’ve done a data cut on a data, which we provided on a preliminary basis to the committee. We will continue to provide data cuts to the committee up to the date of the meeting.

The DMC though, while their purview is to primarily look at neutrophil engraftment and survival by day 28, they will look at all the data in the Phase 1 stage of the study to make their recommendation for advancement into the Phase 2 stage of the study. Chris, feel free to add anything to that..

Sure. Maybe, just one point of clarification as to wondering why hasn’t it just started, I think that was part of the question. And we are still waiting for that last subject to complete that formal 28-day window period. That’s why we are -- it hasn’t yet started. But, we are very encouraged by what we see..

Yes. That was going to be my next question is how many patients have actually gone through the 28 days. Just maybe one quick follow-up on NK100 and AML.

What is -- there happens in previous efforts with NK cells, what is the bar do you think or your internal bar for persistence of the NK100 cells in patients?.

Sure. I think it’s too early to say what our bar is. I mean, we do believe fundamentally that FATE NK100 is a very novel effector cell with some unique property that set it apart from NK cells that are being used in the clinic today.

If you recall all the preclinical data, we have benchmarked against, for instance NK cell therapy that Jeff Miller has been delivering to patients -- is currently delivering to patients for the past couple of years.

So, we feel very confident that FATE NK100 is unique, is different, and we will be able to see that early on with respect, at least [ph]an interesting biomarker that we are looking at, persistence of the NK100 at day 7 and 14. So we think that will be a very interesting indicator with respect to its therapeutic potential.

Jeff in his clinical experience has certainly correlated day 7 and day 14 persistence with enhanced clinical outcomes..

Our next question comes from Jim Birchenough of Wells Fargo. Your line is open..

It’s Nick [ph] in for Jim. Congrats on the progress gentlemen. First off, just on -- just following up on David’s question or rather an answer. Do you need -- it sounds like you need an official go ahead from the DMC but you feel comfortable enough that you don’t need that. I’m just not sure.

So, when the six patients get to 28 days, you send that data out to the DMC, do they formally need to meet and give you the formal go ahead?.

Per the protocol, there is a Phase 1 safety meeting, yes. That meeting can be triggered by a minimum of six patients. We believe per the protocol we are in a position based on a safety data that we have observed to date to support advancement into the Phase 2..

So, you are ready to go essentially when you get the okay from the DMC?.

We are planning to move forward as soon as the Data Monitoring Committee completes its review of six patients. Yes..

Okay.

And are you able to comment on what the maximum grade of GVHD as you’ve seen to date, acute GVHD?.

Yes. We’re not going to comment on patient data at this point in time. The Data Monitoring Committee is doing their job. I really don’t want to be in a position where we’re front running that job with any type of data whether it would be safety or efficacy..

Sure, fare enough. And then moving to the NK100 trials. So, I believe that there is a dose escalation in the ovarian trial. I know in the gene therapy studies, I know FDA is making companies wait between dosing patients and then have DSMB between dose levels.

Do you have any restrictions regarding sequential dosing of patients and then sequential dose levels?.

We haven’t accelerated dose strategy and it’s very similar, it’s not exactly the same, but it’s very similar across all three studies whereby we’re exploring three different dose levels.

Between moving from the first dose to the second dose level, the second dose to the third dose level, we have a short safety window where we need to clear to observe and clear any DLTs that we might observe.

That said, there is no safety monitoring committee per se that is governing advancement from the first dose to the second dose or the second dose to the third dose level.

Once we achieve the top level or at least demonstrate safety to get to the top dose level, we’re in an expansion stage where a number of patients can be treated in parallel during the expansion stage..

Okay, thank you. And then, just last one for me. And I think you indicated that you have a low intensity implication [ph] regimen.

Is that compared to the cause or what are you comparing against, and perhaps what is that regimen you’re using?.

So I’ll let Chris to answer that question. .

Yes. So, what we’re using here, we recall this low-intensive, because it’s being able to be administered as an outpatient. For the DIMENSION study, we’re looking at cytoxan 300 milligrams, we used greater two doses of Fludarabine at 25 milligrams per meter squared. With that, this is being able to be administered in the outpatient setting..

Thank you. Our next question is from Do Kim of BMO Capital Markets. Your line is open..

Hi. Good afternoon. Thanks for taking my questions.

First on ProTmune, I just think maybe it will be helpful, if you pose some potential reasons why the Data Monitoring Committee would require more patients to be kept in the Phase 1?.

Sure. The Data Monitoring Committee is looking at all Phase 1 data. To be clear, that per the protocol, the hurdle to advance from a safety perspective into the Phase 2 efficacy stage is that analysis is done after the sixth patient has reached day 28.

Per the protocol five of the six patients graft by day 28 without graft failure and survived at day 28. The intense per the protocol is to support advancement into the Phase 2. If Data Monitoring Committee though will look at and we are more than happen happy to provide them all data we have available to date..

And you’re saying based on the data that you’ve collected to-date on these five patients and going to sixth patients, you feel confident that all bases are covered to moving on to Phase 2 just on these six patients?.

We would not have convened the meeting after six patients had been dosed, if we were not encouraged by the signals we were seeing with respect to safety..

Okay, great. And on NK100 and iPSC therapies, when we think about putting these therapies in our model, how do you look at future commercialization and potential partnering of these products..

The Company has made over the past, let’s call it, two years a significant shift to become one of the leaders, if not the leader in the NK cell therapy space. NK100 is a very important product to us, we intend to develop that product.

We believe we’re pioneering iPS cell technology, both for NK cells as well as T cells and we’re completely committed to advancing FATE-NK100 as well as IPS derived NK cell and T cell therapies with or without partner.

And we feel very comfortable given our expertise in the space, as well as our partnerships that we have in place with top medical investigators like Jeff Miler in the University of Minnesota and like Michel Sadelain at Memorial Sloan Kettering that we’re well-positioned to advance these products..

[Operator Instructions] Our next question comes from Ren Benjamin of Raymond James. Your line is open..

Hey, guys. Thanks for taking the questions and congrats on the progress. [Technical Difficulty] DSMB today. But, let me just ask [Technical Difficulty]. Typically when I’m looking at DSMB, it’s because you need them to look at blinded [ph] base, and here you don’t have that, in this Phase 1 portion.

So, is there something that they could be looking at specifically that you haven’t? I guess the another way of asking is what [Technical Difficulty] make in the call to look forward to Phase 2, since you’re looking at all the data as well?.

Ren, the protocol was set up over a year ago where as part of setting up and designing a combined Phase 1/2 study, the step to move from Phase 1 to Phase 2 was not to start a new study, not to go back to the FDA but to demonstrate safety where that safety would be determined by an independent third-party.

That was the point of Data Monitoring Committee, that’s the roll of the Data Monitoring Committee. .

Got it.

And then, once the Phase 2 starts, then you guys are blinded completely and the DSMB is the only who kind of [multiple speakers] to the data?.

That’s absolutely correct. So, once the Phase 2 starts, the Phase 2 is being conducted in way that you described is, are very familiar with.

But in designing a Phase 1/2 combined study originally, we believed and we thought it was appropriate, before going into a blinded scenario that a third-party, again, first in human study was ProTmune that an independent third-party would assess safety..

Got it. Scott, was the original protocol for 10 patients, but….

The original protocol for minimum of 6 up to 10..

Got it. Okay. So, I guess that makes a lot more sense than because if you’re going in kind of with lesser patients, you want that additional kind of validation that this is the right path forward..

Correct..

I guess just switching gears real quick to NK100. The first patient to have got dose, but you’ve talked about data coming out in the second half of 2017, can you -- for I guess all the programs.

How many patients worth of data do you think we’ll see? And I am assuming it’s at the Triple meeting or SITC, can you give us a little bit of guidance as to where you might locate that data?.

Sure. I mean, there is obviously high profile conferences that are coming up in the second half of 2017 between SITC and ASH. The endpoints in these studies, I mean we’re looking at a biomarker with respect to day 7 and day 14 with respect to persistence.

We believe that biomarker is important, as I mentioned that NK cell persistence historically has been correlated with complete responses. The first assessment of response with respect to anti-tumor activity across all studies is being assessed, certainly during the first 30 to 40 days.

So, we do believe, across a number of patients, across all three studies, we will be in a position, more certainly, we will be able to look at persistence, and we will be in a position when we will be getting that first look with respect to efficacy..

Got it. And then, just one final question for iPSC. Obviously you put a slide on the ground regarding NKs and you guys want to be the leaders with NK technology.

Is it -- just given how fast the cellular immunotherapy space has advanced, especially when it comes to T cells, does it make sense or are you guys considering potentially using iPSCs, the manufacturing of allogeneic T cells and just coming into that foray?.

Absolutely, that is the intent of our entire collaboration with Michel Sadelain at Memorial Sloan Kettering is to use iPSCs to create off-the-shelf T cell strategies.

Michel recently published a paper that involves essentially knocking out the TCR and inserting a CAR to provide more universality with respect to that T cell, given that the TCR is being knocked and the CAR being inserted, he showed better safety and efficacy with that approach at least in preclinical model.

And so you should assume -- I think it’s fair to assume that that is a path and strategy that we’re aggressively running at with Michel..

Thank you. At this time, I would like to turn the call back over to Mr. Wolchko for any closing remarks.

Sir?.

Thank you. Thank you very much for everyone’s attention today and participation in the call. We look forward to speaking with you in a very near term as we move our programs forward. Thank you..

Ladies and gentlemen, this concludes today’s conference. Thank you for your participation. You may disconnect your lines at this time..