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

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

Welcome to Fate Therapeutics First 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 conference 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 first quarter 2017 financial results call. Shortly after 4 P.M. 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 first quarter ended March 31, 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 first quarter ended March 31, 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 critical development strategy for FATE-NK100 for the treatment of cancer and our advancement of iPSC derived NK cell cancer immunotherapies towards first inhuman clinical trials, including our conduct of formal regulatory meetings with the U.S.

Food & Drug Administration and with UK medicines and healthcare products regulatory agency over the past three months. Chris will provide a brief update on the Phase 1 stage of our PROTECT study of ProTmune and discuss the clinical launch of FATE-NK100 studies.

Dan will provide a preview of the iPSC derived cellular immunotherapy focus session that we are hosting to kick-off the upcoming 2017 annual meeting of the International Society For Stem Cell Research on Wednesday June 14 in Boston.

And I will conclude with a review of our financial results for the first quarter 2017 before opening the call up to questions and further discussion. Let me begin by highlighting several unique properties of Natural Killer or NK cells and their opportunity for use as off-the-shelf cellular immunotherapies for the treatment of cancer.

First, NK cells can intrinsically seek out and kill cancer cells while leaving normal cells unharmed.

Unlike T-cells, that are primarily patient specific and require tumor antigen recognition for effective function, NK cells can be safely transferred from a healthy donor to patients; and their effect or function is not dependent on specific antigen presentation; instead, NK cells can selectively identify stress ligands commonly expressed on tumor cells and secrete cytotoxic granules triggering rapid tumor cell death.

Second, NK cells express CD16, a receptor that can bind the Fc region of a tumor targeting monoclonal antibody and can lyse antibody-coded tumor cells upon engagement.

There is growing preclinical and clinical evidence demonstrating that the efficacy of monoclonal antibody therapy, both in hematologic and solid tumor malignancies is in fact NK cell mediated. Third, NK cells can also release pro-inflammatory cytokines after engaging tumor cells such as tumor necrosis factor alpha and interferon [ph] gamma.

These cytokines can stimulate and recruit a robust, long-lived polyclonal endogenous T-cell response. Through these direct and indirect anti-tumor mechanisms, healthy donor NK cells can bridge innate and adaptive immunity and driving multi-faceted, potent and durable immunological response for the treatment of cancer.

We are developing a pipeline for the activated and engineered NK Cell products for the treatment of cancer.

We are executive on a multi-pronged clinical development strategy addressing both hematologic and solid tumor malignancies including the use of our NK cell products as monotherapy and in combination with other anti-tumor agents such as monoclonal-antibodies. We have successfully launched clinical development of our first NK Cell product, FATE NK-100.

A first in class, donor derived NK Cell cancer immune therapy. FATE NK-100 is comprised and have been activated sub-population if NK Cells called adaptive memory NK Cells. The cell product is highly differentiated from conventional NK therapies that are being clinically administered today.

We have shown in preclinical studies that FATE NK-100 has enhanced anti-tumor activity across broad range of liquid and solid tumors. Augmented release of pro-inflammatory cytokines, improved functional persistence and increased resistance to immune checkpoint pathways.

In March, the US Food and Drug Administration authorized an investigational new drug application for FATE NK-100 for refractory relapsed AML, a disease for which patients have very poor prognosis and very few treatment options.

Clinical investigation of conventional NK Cell therapy has demonstrated safety and complete response rate of up to 30% have been recorded. We are sponsoring an investigator initiated first in human clinical trial of FATE NK-100 for refractory relapsed AML at the Masonic Cancer Center, University of Minnesota, which we refer to as the voyage study.

The voyage study is open label and is utilizing accelerated dose escalation to evaluate the safety and anti-tumor activity of a single intravenous infusion of FATE NK-100.

We believe the voyage study has the potential to demonstrate clinical proof of concept and show therapeutic differentiation of FATE NK-100 in refractory relapsed AML after treating only a small number of subjects. I am pleased to announce that the voyage study is now open for enrollment and the first subject has been consented for participation.

We expect to share initial clinical data from the voyage study at a scientific conference in the second half of 2017. Last week the FDA authorized a second IND for FATE NK-100, extending our critical development strategy for FATE NK-100 into solid tumor malignancies, including in combination with monoclonal-antibody therapy.

We have demonstrated in preclinical studies that FATE NK-100 significantly augments antibody directed cellular cytotoxicity against cancer cells when it is ministered in combination with a monoclonal antibody, including antibodies that target CD-20, HER2, and EGFR antigens.

To our knowledge this is the first ever authorization by the FDA for the clinical investigation of allogeneic NK Cells in combination with the trastuzumab which is FDA approved for certain advanced HER2 positive cancers or with the monoclonal antibody cetuximab which is FDA approved for certain advanced EGFR1 positive cancers.

Trastuzumab sold under the brand name herceptin and cetuximab sold under the brand name erbitux are 2 of the world's leading monoclonal antibodies therapies for the treatment of solid tumors. We plan to properly initiate this landmark clinical trial of FATE NK-100, which we refer to as the dimension study.

We plan to enroll subjects in an outpatient setting concurrently across three FATE NK-100 treatment arms.

As monotherapy for solid tumor malignancies including small cell lung cancer and hepatocellular carcinoma in combination with Trastuzumab for advanced HER2 cancers including breast and gastric cancers and in combination with cetuximab for advanced EGFR1 positive cancers, including colorectal and head and neck cancers.

We expect the dimension study to begin enrollment in the second half of 2017. In the coming months, we plan to continue to aggressively expand our clinical investigation of FATE NK-100 with our collaborators from the University of Minnesota, we're currently preparing to file a third IND for FATE NK-100 for recurrent ovarian cancer.

We are also engaged in discussions with investigators to develop FATE NK-100 in combination with FDA approved monoclonal antibody therapy for hematologic malignancies.

In addition to our development of FATE NK-100, we're using our proprietary induced pluripotent stem cell or iPSC product platform to create master pluripotent cell lines for developing first of kind products, including NK Cell products.

Similar to master cell lines used for the manufacture of therapeutic antibodies, pluripotent cell lines have the potential to serve as a renewable source for the consistent manufacture of clono 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.

The -- of a sell product from a master IPS line is a revolutionary new paradigm for the creation of cell therapies. Because there is limited precedent for this approach, we recently requested and were granted formal meetings with regulatory authorities in the United States and the United Kingdom.

In March and April, we held a pre-IND meeting with the FDA and a Scientific Advice Meeting with the MHRA respectively.

We reviewed our preclinical development, proposed manufacturing plants and clinical trial design for our hnCD16-iNK cell product candidate an off the shelf targeted NK Cell immune therapy derived from a master engineered iPSC line expressing a novel high affinity, non-cleavable CD16 FC receptor.

These formal engagements with the FDA and the MHRA were highly productive, very pleased with the constructive feedback and these engagements substantially confirm our alignment with both regulatory agencies in bringing our IPS derive cell products into human clinical trials. I would like to convey three general comments regarding these engagements.

First; both agencies currently view the drug product for what it is, a fully differentiated NK Cell product. As with any drug product, we are responsible for characterizing the final drug product and demonstrating sufficient purity of the final drug product to the satisfaction of regulatory agency standards.

In preclinical production, our IPS derived NK Cells have a molecular signature that is substantially similar to peripheral blood in NK Cells and at our lowest level of detection do not contain any residual induced pluripotent stem cells.

Second; both agencies currently view our manufacturing plants as Phase appropriate and sufficient to support first-in human clinical studies.

We're collaborating with molecular and cellular therapeutics at the University of Minnesota, a state of the art GMP compliant manufacturer of cell and tissue based products for clinical manufacture of our IPS derived NK Cell products.

We have completed technology transfer about iPSC product platform to the University of Minnesota and we expect to initiate GMP validation runs in the third quarter of 2017. Third, both agencies currently view our first-in human clinical trial design as reasonable.

Our proposed first-in human clinical trial design includes multiple parallel arms to investigate our hnCD16-iNK cell product as a monotherapy and in combination with monoclonal antibody therapy. Based on these interactions with the FDA and MHRA, we believe we have a clear path to realize this revolutionary therapeutic paradigm.

We are on track to be the first company in the world to treat a patient with a cancer immunotherapy derived from a master pluripotent cell line. We expect to file applications with both the FDA and the MHRA within the next 12 months to conduct first-in human clinical trial of a first of kind IPS derived NK Cell product for the treatment of cancer.

I will now turn the call over to Dr. Chris Storgard our Chief Medical Officer who will provide a brief update on the Phase 1 stage or protect study of ProTmune and discuss the clinical launch of our FAT NK-100 studies in more detail..

Thanks Scott. As Scott mentioned, I will provide an update on the status of our clinical studies and our planned or anticipated data release during this busy and exciting year. Let me begin first with PROTECT.

So our Phase 1, 2 study of ProTmune for the prevention of acute graft versus host disease or GVHT in patients receiving a maxed, unrelated mobilized peripheral blood transplant. We continue to maintain a high level of engagement and enthusiasm with our investigators. We have now opened 11 clinical sites in the U.S.

and we are currently working to activate up to a total of 20 sites, including sites in the United Kingdom. Our plan to complete enrollment of the Phase 1 stage by mid-2017 remain on track. As a reminder, the PROTECT Phase 1 stage is intended to access the safety of ProTmune.

An Independent Data Monitoring Committee will assess safety by evaluating Neutrophil Engraftment and survival at day 30 following transplant. I’ve said that the safety concerns Phase 2 stage of the PROTECT study will open for enrollment.

We expect a report PROTECT Phase 1 safety data including both Neutrophil Engraftment and survival at day 30 post transplant promptly following the Independent Data Monitoring Committee accessments. In addition to accessing safety, Phase 1 also has the potential to demonstrate early clinical proof of concept.

It's up to 60% of patients experienced acute GVHD within the first 100 days following transplant. We plan to report day 100 efficacy data for the Phase 1 safety stage including the incidents and severity of acute GVHD and survival once the data is available.

The Phase 2 stage of PROTECT is designed as a randomized control, stratified and blinded study for the evaluation of 60 subjects. 30 receiving ProTmune at 30 receiving a standard of care peripheral blood cell graft.

The primary endpoint, the incident of great through - acute GVHD by day 100 and the key secondary endpoint incidental CMB reactivation by day 100 are clearly defined and it tends to be objectively confirmed by 2 separate and independent event adjudication committees. The statistical analysis plan is pre-specified and controls for multiple endpoints.

As such we believe that PROTECT once completed has the potential to support accelerated approval. Let me now shift to FATE NK-100, our first in class adaptive memory NK Cell product. There's a lot of excitement about the clinical potential of FATE NK-100.

Through our proprietary --activation process, we are able to reproducibly manufacture, therapeutically relevant quantities of a homogeneous and consistent population of NK Cells. That is enriched for a select and specific subset of cells called adaptive memory NK Cells.

We believe that FATE NK-100 provides several distinct and differentiating advantages over conventional NK Cell therapies that are being administered in clinical studies today including at the University of Minnesota.

For example, in multiple preclinical models FATE NK-100 has demonstrated superior tumor cell killing both as monotherapy and when used in combination with ADC inducing monoclonal antibodies.

The superior activity that's driving the excitement and the anticipation for clinical testing of FATE NK-100, especially given that investigators at the University of Minnesota currently observe around 25% to 30% complete response rate, in patients relapsed or refractory AML with conventional NK Cell therapies.

We were taking an aggressive approach to evaluate the clinical potential of FATE NK-100 and expect to treat a number of subjects with many tumor types across 3 distinct clinical studies this year. The first study name voyage will evaluate Fate NK-100 and relapse and refractory AML and is now open for enrollment.

In fact as Scott mentioned, the first subject in voyage is being contented. This first-in human study will enroll adult subjects with relapsed or refractory AML, all subjects will receive a cytoxin fludarabine - conditioning regimen and will receive low dose IL2 subcutaneously every other day for 2 weeks for NK Cells of course.

Since minimal toxicity is expected the FDA has agreed to an accelerated dose escalation design. Where one subject will be enrolled per dose level, up to 4 dose levels are planned. We then intend to expand enrollment up to a total of 10 subjects at the maximum tolerated dose.

Clinical activity will be assessed by determining the rate of complete remission at day 42. We will also determine clearance of minimal residual disease as well as one year leukemia survival and overall survival.

We are optimistic about the potential for FATE NK-100 to demonstrate complete remissions by the end of this year, which could then support initiation of a registration study in relapse refractory AML in 2018.

The second clinical study of FATE NK-100 named Apollo is planned to evaluate the safety and activity of the escalating doses of FATE NK-100 administered intraperitoneally in women with advanced ovarian, fallopian tube or primary peritoneal cancer.

The Apollo study, which we plan to conduct at the University of Minnesota, we’ll enroll -- resistant subjects as well as - sensitive subjects following tumor progression. This is the high unmet need population with poor prognosis with an expected progression free survival of less than 6 months.

All subjects will have measurable tumor burden at entry and anti-tumor activity will be assessed by observation of tumor shrinkage by resist criteria. Those subjects with stable disease or better can be considered for a second repeat intraperitoneal administration of FATE NK-100.

This setting provides a unique opportunity to evaluate the persistent and activity of FATE NK-100 when delivered directly to the side of tumor via interperitoneal administration. We anticipate enrolling the first subject in the Apollo study in the third quarter of this year.

Our third clinical study of FATE NK-100 named DIMENSION was cleared for initiation last week by the FDA. As Scott mentioned, the FDA’s clearance of this IND is a significant milestone, providing the opportunity for the first time in the US to evaluate the synergy of allogeneic NK Cell therapy and a monoclonal antibodies Trastuzumab and cetuximab.

NK Cells are the key factor cells mediating antibody directed cellular cytotoxicity or ADCC, which occurs when the NK Cells interact with antibody coded tumor cells. Additionally, NK Cells can intrinsically sneak out and directly kill transfer room cancer cells and can trigger a long lived adaptive T-Cell immune response.

We believe this study represents a powerful new immunologic approach to the treatment of solid tumors that bridged both the niche and adaptive immunity. The DIMENSION study cleared by FDA will evaluate the safety and the anti-tumor activity of FATE NK-100 across 3 different treatment arms in an outpatient setting.

Each of the 3 arms of the DIMENSION study will utilize an accelerated dose escalation design beginning with dose cohorts of one subject per dose level. The first arm will evaluate FATE NK-100 as monotherapy in an all commerce solid tumor population.

Clearance of the 28 day dose limiting toxicity observation period in this first monotherapy subject will then enable the start of the combination treatment arms at which point all 3 treatment arms can enroll in parallel and can dose escalate independent of each other.

The treatment arm of FATE NK-100 and Trastuzumab can enroll any advanced HER2 positive cancer, including breast and gastric cancer that have progressed on Trastuzumab. The treatment arm of FATE NK-100 and cetuximab can enroll any advanced EGFR1 positive cancer including colorectal and head and neck cancers that have progress onto Trastuzumab.

Of note advanced RAS mutant colorectal cancer subjects will be eligible. As we would anticipate this large unmet need population, to be sensitive to the ADCC induced by cetuximab and FATE NK-100.

The combination arms will evaluate up to four dose levels of FATE NK-100 in combination with the FDA approved weekly dose of Trastuzumab and the FDA weekly dose of cetuximab. Following dose escalation up to an additional 20 subjects maybe enrolled per treatment arm.

In addition, when a resist partial response is observed the protocol permits an additional expansion of up to 10 subjects in that tumor type.

We have specifically designed the DIMENSION study to robustly and rapidly assess the tumor activity, the FATE NK-100 across multiple solid tumors with the intention for rapid advancement into subsequent registration enabling studies.

Given the scope of the DIMENSION study we plan on enrolling in 3 clinical sites during dose escalation and plan 3 additional sites during the maximum tolerated dose expansion. We expect enrolment of the DIMENSION study to begin in the second half of 2017.

I will now turn the call over to Dan to discuss our iPSC product platform and the focus session that we are hosting to kick off the upcoming 2017 annual meeting of the International Society for Stem Cell Research..

Thanks, Chris. We continue to make exciting progress using our iPSC product platform to advance a one cell many patients approach to cellular immunotherapy for treating cancer and immune disorders.

We believe the use of human induced pluripotent cells as master cell line is central to enabling off the shelf treatment of many thousands of patients without requiring patients or so.

We're looking forward to providing a comprehensive update on our iPSC platform at the upcoming 2017 annual meeting of the International Society for Stem Cell Research in Boston on June 14. We're kicking off ISSCR by hosting a 3 hour focus session entitled Off the Shelf Natural Killer Cell Cancer Immunotherapy.

The session will feature renowned guest speakers including doctors Seth Miller, Kelly Naumberg, Bob Valamehr and Dan Kosman. The presenters will provide an in depth scientific overview of the company’s industry leading iPSC product platform, it will highlight several iPSC derived NK product opportunities undergoing preclinical development.

These include the hnCD16-iNK product which is created from a master iPSC line engineered to express the novel CD16-sc receptor. This receptor has been modified to increase its surface expression by preventing activation induced setting and to increase the affinity to therapeutic antibodies.

Additional product opportunities to be a showcase include NK Cells derived from master iPSC lines engineered to express merit antigen receptors. The focus session will also include a discussion on the manufacturing and regulatory considerations for bringing iPSC derived cellular immune therapies to patients.

It addition to hosting the focus session, we plan to present an abstract at ISSCR with preclinical data solid our development of an off the shelf iPSC diversion of our product candidate for the treatment of autoimmune and inflammatory diseases.

We now have demonstrated that iPSC drive -- presented herself or IPTC can partly suppress disease causing T-Cell and that this activity is not dependent on a chilly matching. In recent preclinical studies we have shown that iPSC have enhanced level of immune regulatory activity as compared to T-Cells.

Finally, we have established a scale on manufacturing process to generate our iPSC derived immunoregulatory product candidates. I will now turn the call back over to Scott to review our first quarter 2017 financial results..

Thanks Dan. Turning to our financial results for the first quarter ended March 31, 2017 Fate Therapeutics reported a net loss of $10.2 million or $0.24 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 first quarter 2017 compared to $1.3 million for the same period last year. Revenue in both periods was generated from our strategic research collaboration with Juno Therapeutics. Research and development expenses for the first quarter of 2017 were $8.0 million compared to $6.6 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 NK-100 and a preclinical advancement of our off the shells cancer immunotherapy programs. G&A expenses for the first quarter of 2017 were $3.0 million compared to $2.6 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 $900,000, total operating expenses for the first quarter of 2017 were $9.6 million.

At the end of the first quarter of 2017, cash, cash equivalents and short-term investments were $82.3 million; debt outstanding under our facility with Silicon Valley Bank was $8.8 million; common stock outstanding was approximately 41.4 million shares; and preferred, convertible stock outstanding was approximately 2.8 million shares.

Note that one share of preferred stock is convertible into five shares of common stock under certain conditions. In conclusion, the next several months promise to be eventful and exciting.

With ProTmune, we expect to read out the initial Phase 1 stage or PROTECT study and get a first look at the products potential to change the field of allogeneic hematopoietic cell transplantation.

With FATE NK-100, we expect to begin enrolling subjects across 3 different clinical settings, including in AML where there is strong clinical precedent and in solid tumors in combination with trastuzumab and with cetuximab which to our knowledge will be the first ever clinical investigation in the United States of an allogeneic NK Cell adoptive immunotherapy in combination with these monoclonal antibodies.

With our iPSC product platform, we continue to lead in innovation and are driving to become the first company ever to advance the cancer immunotherapy created from the master pluripotent cell line to clinical development. And with that, I’d like to turn the call over to the operator for any questions..

And your first question comes from Ren Benjamin with Raymond James. Your line is open..

Hi, good afternoon guys. Thank you so much for taking the question. This has been -- congrats on the progress for the quarter. I have a couple here. First one is on the FATE NK-100 AML study. So maybe can you sort of talk about the type of data that you want to see or you have to see so that you feel comfortable to move this study.

Is this product into a pivotal study in 2018? And then I will have a follow-up. Thank you..

Sure. So I think what’s been seen in the industry in -- investigators so far away it NK Cells has been about 25% to 30% complete response rate in refractory relapse to AML. So from our perspective, we fundamentally believe FATE NK-100 is a substantially better product than the product that is being administered today.

All our preclinical studies, we used conventional NK cells that are being clinically administered today as the benchmark against which we compared FATE NK-100 and across the board, whether you look at cytotoxicity, whether you look at persistence, whether you look at resistance to immune checkpoint pathways.

Setting FATE NK-100 we believe is a far superior product. So certainly from our perspective, we would be looking for response rates that are absolutely north of 30%..

Got it. That’s very helpful. Thank you. And then another question is on the DIMENSION study.

So when do you think we might see some data and also maybe a similar question is for those combination studies with approved monoclonal antibodies what would be considered a win in terms of efficacy there?.

Sure. With respect to FATE NK-100 and monoclonal antibodies, I’ll turn that over to Chris and he can comment on some of the end points we’re looking at and would be excited about with respect to that combination.

Our plan with respect to FATE NK-100 and the clinical studies, we plan to provide an update at a scientific conference in the second half of 2017 discussing just a general program, as well as the clinical development studies that are being conducted.

All studies are open label, so we do have the ability to highlight the results that we’re seeing across all 3 clinical studies..

Great. And regarding what we consider a win..

We actually have many shots on goal here that we think will be clear evidence of the potential for registration studies moving forward. So the first is we are going to be looking at those subjects who've already progressed on the approved therapy.

So for instance with trastuzumab dose with HER2 positive breast cancer or gastric cancer who have progressed on trastuzumab. And in that setting, if we see a partial response in that setting we have clear evidence that it’s due to the combination.

In that setting there has been clear precedence that a potential for monotherapy single arm open label study in a refractor population to potentially support approval. Obviously, that would that be dependent upon further discussions with the regulators.

Similarly with cetuximab, we have - we’ll be enrolling those who have progressed on cetuximab with colorectal cancer, head and neck cancer. So that again is clear evidence, and a clear win, if we are seeing partial response, especially durable partial responses there. There will be some other clear opportunities here.

I think the one that I'm very excited about are the RAS mutant colorectal cancer patients. We know for certain that the monotherapy, the EGFR monoclonals are not effective. However, we believe the synergy with the ADCC mechanism that we're looking to at developing here is an significant opportunity.

So signals again there are persistent durable responses, I believe are clear opportunities for potential future registration..

Got it. That's very helpful. Thank you so much. Good luck going forward..

Thanks..

And we do have a question from Do Kim with BMO Capital Markets. Your line is open..

Thank you. Thanks for taking my question.

Just a follow up on the NK-100 what would you think would be the appropriate comparator from a regulatory perspective? Do you think that the FDA would allow a clinical study compared versus conventional NK Cell therapy or would approved product be appropriate comparator?.

So again, it depends on which setting we’re looking at. So let’s talk first about the AML. Again, with the - really I would say remarkable remission rate that has been observed with NK Cell therapies and our expectation to see even above 30%.

I think there is precedent that when you're saying a meaningful clinical response in a relapsed refractor population that that may in itself be sufficient without the need for a comparator.

Again this will be in further discussions with the FDA, but I believe there has been precedence that in a situation like that with clear medical and clinical value added with durable response rates in a unmet need population the single arm studies have been acceptable for registration, but discussions and data will determine..

And one thing just to make clear, in case I didn’t make it clear in my comments. The NK Cell therapies that are being given today are not approved or investigational. So the idea of running a comparative study as Chris mentioned I don't think is the path forward in demonstrating efficacy for FATE NK-100..

Okay. Got it.

And in your pre-IND discussion for your iPSC therapy are you finding them similar to what you went through for NK-100 or the FDA bringing up different question?.

Certainly bringing up much different questions, it's a very different paradigm with respect to using a master cell line to create a cell therapy as opposed to FATE NK-100 which is a donor derived product and it's really an enrichment strategy about creating a preferred phenotype with unique cancer immunotherapy properties.

An iPSC approach is very revolutionary, it's very disruptive, and it is a completely new paradigm for cell therapy. I think -- obviously I think an iPSC approach has tremendous advantages over the current approaches to cell therapy today.

So yes, it is very new with respect to the FDA's mindset in thinking about that; yet as I discussed, I do think they remind based on our discussions and what their view of this product, it is -- I think it is considering the product and NK cell therapy as opposed to it's a pluripotent cell.

Sure we start with a pluripotent cell and that is a new approach, the idea of starting with a pluripotent cell is clearly a new approach; but at the end of the day the product that we are creating is a fully differentiated NK cell and I think we were fundamentally pleased with a feedback that we got from the FDA and from MHRA in the recognition that the drug product that we are delivering to patients is a fully differentiated NK cell..

Great, very helpful. Thank you for taking my questions..

[Operator Instructions] And your next question comes from David Nierengarten with Wedbush. Your line is open..

Thanks for taking the question.

Maybe if you could just review for us and remind some investors out there, what we should be seeing when you report out the first 10 patients for ProTmune, is it -- are we going to be able to see a 28-day safety? Is it -- are there going to be some patients out to 100-days that you can report on or are you going to report on the same time point and data for the whole group of patients? Thanks..

Sure. So our view of this is, the data monitoring committee is assessing safety. They are assessing safety at dates already post-transplant. The safety assessment primarily is focused on two measures; number one, engraftment; and number two, survival at Day 30.

And so our current view is when we report the Phase 1 stage, we will be reporting on the safety assessment as conducted by the data monitoring committee. When all patients reach Day 100, we will report out the efficacy readout 'from the Phase 1 stage study which will then look at rates of GDHD, rates of infection and survival at Day 100.

So there will be two sets of data release with respect to the Phase 1 stage, the safety assessment and the findings of the data monitoring committee from the safety assessment which importantly, the findings of the data committee and the safety assessment will allow us to begin Phase 2.

So we will initiate Phase 2 based on the safety findings from the DMC; while the Phase 2 is up and running, patients will continue to progress to Day 100 and we will read out Day 100 when all patients have reached Day 100..

Got it. And the gating factor again is just the data safety monitoring committee; you're reporting out -- it's safe and you can progress on the patients you don't need to -- that you don't need any other data points; just to confirm..

Yes, it's very clear what their preview is and what the measures are of safety..

Got it. Thanks..

And I'm not showing any further questions at this time. I would like to turn the call back over to Scott Wolchko for any further remarks..

Terrific. Thank you very much. I appreciate everyone's attending and interest rates in our first quarter 2017 financial update call. We look forward to talking to you in about three months. Thank you..

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