Fate Therapeutics, Inc. (FATE) Q1 2019 Earnings Call Transcript

Fate Therapeutics, Inc. (FATE -5.02%)
Q1 2019 Earnings Call
May 7, 2019, 5:00 p.m. ET

Contents:

• Prepared Remarks
• Questions and Answers
• Call Participants

Prepared Remarks:

Operator

Welcome to the Fate Therapeutics First Quarter 2019 Financial Results Conference Call. At this time, all participants are in a listen-only mode. This call is being webcast live on the Investor and 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. Please begin, sir.

Scott Wolchko -- Chief Executive Officer and President

Thank you. Good afternoon and thanks, everyone, for joining us for the Fate Therapeutics First Quarter 2019 financial results call. Shortly after 4:00 p.m. Eastern Time today, we issued a press release with these results, which can be found on the Investors and Media section of our website under Press Releases. In addition, our Form 10-Q for the quarter ended March 31, 2019 was filed shortly thereafter and can be found on the Investors and Media section of our website under Financial Information.

Before we begin, I'd 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 quarter ended March 31, 2019 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 is Dr. Dan Shoemaker, our Chief Scientific Officer. Since 2015, Fate Therapeutics has held true to a bold vision that induced pluripotent stem cell, or iPSC, technology would serve as the platform for developing and commercializing off-the-shelf cellular immunotherapies. We first saw the unmatched potential to use clonal master iPSC lines as a renewable cell source for the mass production of cell products that are uniformly engineered, extensively characterized, consistently manufactured, and delivered on demand to reach more patients.

Based on our unwavering commitment to this vision, we have built an industry-leading iPSC product platform supported by deep collaborations with top investigators and leading research centers, numerous peer-reviewed publications, and an intellectual property portfolio of over 100 issued patents and 100 pending patent applications. And we have built a robust pipeline of unique and highly differentiated off-the-shelf NK cell and T-cell product candidates with the hope of delivering transformational change in patient outcomes.

Our conviction that clonal master iPSC lines will serve as the foundation for developing and commercializing cell-based cancer immunotherapies has been further validated by three recent trends emerging in the field. First, we continue to see numerous limitations inherent in patient and donor-derived cellular immunotherapy where heterogenous populations of primary cells are sourced, engineered in large batches, and expanded with each manufacturing run resulting in cell-to-cell and batch-to-batch variability that can affect product safety and efficacy. In contrast, iPSC-derived cell products are homogenous, each originating from a single engineered iPSC clone that is extensively characterized, precisely selected, and repeatedly used for product manufacture.

Second, recently published longitudinal patient outcomes following single administration CAR T-cell therapy have convincingly demonstrated that long-term durable remissions are most highly correlated with early disease intervention, rapid tumor elimination, and the manufactured products effector function, and not necessarily long-term CAR T-cell persistence. In fact, the antitumor effects of a single administration CAR T-cell treatment are providing to be short-lived in many patients and relapse is now commonly observed, including in patients with persisting CAR T-cells.

Since iPSC-derived cell products can be mass produced at low cost per dose, cryopreserved, and delivered on demand, the opportunity exists to administer multiple off-the-shelf doses of a cell product. This clinical paradigm uniquely enables continuous therapeutic exposure to optimize effector cells over weeks and months, including in combination with established early line therapeutic agents that have complimentary and synergistic mechanisms of action such as checkpoint inhibitors and monoclonal antibodies. And consequently, this paradigm has the potential to convey more durable responses.

Third, multifunctional elements such as the concurrent targeting of more than one tumor-associated antigen are rapidly being embedded into cell-based cancer immunotherapies to further enhance the clinical activity of effector cells. While this is promising, the complexity of product design and manufacturing is significantly increased. In contrast, we believe multiple functional elements can be more effectively evaluated using clonal master iPSC lines where distinct functional configurations can be systematically introduced, extensively characterized, and assessed for safety and activity, and where the clonal master iPSC line with the "winning multifunctional configuration" can be used as the renewable cell source for repeated manufacture of a homogenous cell product.

These past several months have been particularly inspiring for the company as our multiyear journey to bring iPSC-derived cellular immunotherapies to patients with cancer is now being realized. In February, we initiated a landmark clinical trial of the first ever iPSC-derived cell product cleared for clinical investigation in the U.S. FT500 is a universal, off-the-shelf NK cell cancer immunotherapy derived from a clonal master iPSC line. In preparation for the clinical investigation of FT500, hundreds of doses of FT500 were manufactured in a single GMP campaign. Each dose was cryopreserved in an infusion-ready bag. The cryopreserved cell product was validated against stringent post-thaw release specifications, including identity, purity, viability, and potency, and FT500 was shipped to participating clinical sites for off-the-shelf use as a thaw and directly infused cell product.

FT500 is currently being investigated in an open-label multidose Phase 1 clinical trial for the treatment of advanced solid tumors. The study is designed to assess the safety and activity of three once-weekly doses of FT500 as a monotherapy and in combination with one of three FDA-approved checkpoint inhibitor therapies -- nivo, pembro, and atezo -- in patients whose tumors failed to respond or progressed following initial response with the prior checkpoint inhibitor therapy. Patients who are clinically stable following the first cycle of FT500 treatment are eligible to receive a second treatment cycle of three additional once-weekly doses of FT500.

Despite the clinical benefit conferred by approved checkpoint inhibitor therapy against a variety of tumor types, these therapies are not curative, and in most cases, patients either fail to respond or progress on therapy. One common mechanism of resistance to checkpoint inhibitor therapy is associated with the loss of function mutations in genes critical for antigen presentation such as beta-2-microglobulin which results in loss of MHC Class 1 expression. Since NK cells have the inherent capability to recognize and directly kill tumor cells with these mutations, we believe FT500 represents a novel therapeutic strategy to potentially overcome checkpoint inhibitor resistance.

Last week at the American Society of Gene & Cell Therapy conference, we announced that three patients with advanced solid tumors have now been treated with multiple doses of FT500 at the first dose level of 100 million cells per dose in the study's monotherapy arm. All three patients received three once-weekly doses of FT500 in an outpatient setting in the first treatment cycle, which was well-tolerated with no dose-limiting toxicities or serious adverse events reported during the initial 28-day observation period.

In accordance with the clinical protocol, all three patients advanced to a second multidose treatment cycle of FT500, which again has also been well-tolerated with no dose-limiting toxicities or serious adverse events reported to date. We are particularly encouraged with these initial clinical observations as this clinical trial of FT500 is one of the first studies where multiple doses of a universal, off-the-shelf cell therapy have been administered to patients.

As I previously mentioned, it has now been shown that persistence of a single administrated therapy is not sufficient to prevent relapse nor is long-term persistence correlative with patient survival. This is explained in part by the reduction of effector cell function over time in vivo, which is most often caused by the exhaustion and anergy of the persisting cells. Consequently, we believe a multidose therapeutic course that enables repeat delivery of optimized effector cells over a period of weeks to months will ultimately lead to deeper and more durable responses as compared to single-administration therapy. At this time, we have open patient enrollment at the second dose level of 300 million cells per dose of FT500 in the monotherapy arm. In addition, we have open patient enrollment at the first dose level of 100 million cells per dose of FT500 in the checkpoint inhibitor combination arm.

In addition to achieving these important clinical milestones with FT500, we continue to advance FT516, our second product candidate emerging from our iPSC product platform toward first patient enrollment. FT516 is a universal, off-the-shelf targeted NK cell product candidate derived from a clonal master iPSC line engineered to express a novel high-affinity, non-cleavable CD16, or hnCD16, Fc receptor. To our knowledge FT516 is the first-ever cell product derived from a genetically engineered pluripotent stem cell cleared for clinical testing worldwide. CD16 is naturally expressed on NK cells and mediates antibody-dependent cellular cytotoxicity, or ADCC, a potent antitumor mechanism by which NK cells recognize, bind, and kill antibody-coated cancer cells.

Consequently, ADCC is dependent on NK cells maintaining active levels of CD16 surface expression. The expression of CD16 though on NK cells -- endogenous NK cells -- has been shown to undergo considerable down regulation in cancer patients, which can significantly limit antitumor activity. Additionally, CD16 naturally occurs in two variants, either with 158V high or 158F low affinity, for the Fc domain of IgG1 antibodies. Numerous clinical studies with FDA-approved tumor-targeting antibodies, including rituximab, trastuzumab, and cetuximab, have demonstrated that patients homozygous for the CD16 high-affinity variant, which only occurs in about 15% of patients, have significantly improved clinical outcomes. FT516 incorporates a novel hnCD16 Fc receptor, which maintains active levels of surface expression of the high-affinity variant to augment binding to tumor targeted antibodies for enhanced ADCC.

At the 2019 American Association for Cancer Research conference in April, the company presented pre-clinical data using a B-cell lymphoma line showing that approximately 70% of peripheral blood NK cells lost CD16 expression upon coculture with rituximab, while CD16 expression on FT516 remained intact and active. These differences resulted in a significant antitumor benefit with FT516 in vivo, where in a human lymphoma cancer model, mice treated with peripheral blood NK cells and rituximab had a median survival time of only 39 days as compared to mice treated with FT516 and rituximab, where the median survival time had not been reached at Day 100. Our therapeutic objective with FT516 is to improve aged patient outcomes in the 85% of patients that inherently have lower levels of ADCC due to expression of the CD16 low-affinity variant.

At this time, a cGMP production run for FT516 has been completed, and the final product release testing is ongoing. The company intends to clinically investigate FT516 for the treatment of relapsed/refractory hematologic malignancies, including in combination with certain FDA-approved monoclonal antibody therapies. We expect to open the FT516 study for patient enrollment in mid-2019.

At the 2019 American Association for Cancer Research in April, we presented new pre-clinical data on FT596, the third product candidate emerging from our iPSC product platform. FT596 is the company's first universal, off-the-shelf CAR NK cell product candidate and is derived from a clonal master iPSC line engineered with three distinct functional modalities: a potent CAR targeting CD19 that is specifically designed to augment NK cell activity, a novel hnCD16 Fc receptor for enhanced ADCC, and a unique IL-15 receptor fusion for improved NK cell proliferative capacity and functional avidity. Moreover, FT596 naturally expresses other activating receptors such as NKG2D to provide additional capacity to recognize and kill cancer cells.

While multiple groups are developing autologous and allogeneic CAR T-cells that target a single-tumor associated antigen, we believe the next wave of innovation in cell-based cancer immunotherapy will utilize concurrent targeting of multiple tumor-associated antigens. Clinical experience with first generation CAR T-cells both in the case of single-antigen targeted CAR T-cells against CD19 in leukemia and lymphoma and against BCMA and myeloma have clearly demonstrated that not all patients respond, and even for those patients that initially respond, durability of response remains a significant limitation of therapy. Amongst the earliest identified mechanisms of relapse is down regulation or loss of the target antigen from the tumor cell's surface. To mitigate these limitations, next generation cancer immunotherapies are incorporating multitargeted antigen strategies to reduce the risk of disease relapse due to target antigen escape.

FT596 is on the forefront of this next wave of cell-based cancer immunotherapies that are specifically designed to engage multiple antigens. In preclinical studies, we have shown that the concurrent activation of the CAR-19 and hnCD16 targeting modalities of FT596 exerts synergistic antitumor activity. In the cellular cytotoxicity [inaudible] designed to model CD19 antigen escape, FT596 combined with rituximab was able to effectively eliminate leukemia and lymphoma cancer cells that were positive for CD19 antigen expression as well as cancer cells that were negative for CD19 antigen expression, supporting the premise that multi-antigen engagement of CD19 and CD20 may illicit a deeper and more durable response.

I am pleased to announce that the generation of the clonal master iPSC bank for FT596 has now been completed. The clonal master iPSC bank is derived from a single iPSC clone that was specifically selected based on a series of critical attributes, including preferential genomic integration sites of the engineered elements, maintenance of genomic stability, demonstration of highly efficient and reproducible production of the NK cell product candidate, and robust post-cryo viability and multipurpose functional activity of the product candidate. Currently, IND-enabling activities, including a completion of manufacturing pilot runs for FT596 are being conducted at Fate. We continue to remain on track for a mid-year submission of the IND application for FT596. Our intent is to clinically investigate FT596 as a monotherapy and in combination with monoclonal antibody therapy in patients with advanced B-cell lymphomas.

We also continue to be very pleased with the progress we are making under our exclusive iPSC-derived T-cell collaboration with Memorial Sloan Kettering led by Dr. Michel Sadelain for the development of universal, off-the-shelf TCR-less CAR T-cell product candidates. Based on the latest preclinical data emerging from the Sadelain lab pertaining to CAR T-cell biology, we continue to believe that our FT819 product candidate incorporates best in-class components and design attributes for CAR T-cell products. Dr. Sadelain recently published in the Journal of Nature that directing a CD19-specific CAR to the T-cell receptor alpha constant, or TRAC, locus enhances T-cell potency and that these TRAC-targeted CAR T-cells vastly outperform conventionally generated CAR T-cells and a mouse model of acute lymphoblastic leukemia.

Additionally, Dr. Sadelain has shown and published work described in the journal of Nature Medicine that CAR designs utilizing a 1XX CD28 zeta variant result in CAR T-cells with potent activity and increased resistance to exhaustion as compared to conventional CD28 and 4-1BB CAR constructs in preclinical models. We have now demonstrated that the production of clonal master engineered iPSC lines having integration of a 1XX CAR targeting CD19 into the TRAC locus with complete elimination of T-cell receptor expression to avoid graft-versus-host disease.

Additionally, we have demonstrated our unique ability to screen thousands of iPSC clones to identify and select for those with the desired on-target edits and a void of off-target edits and translocations. Final selection of the single iPSC clone for generation of the clonal master iPSC bank for FT819 is ongoing.

Finally, we continue to focus on building the organizational talent and capabilities required to realize our bold vision. The buildout of our in-house GMP manufacturing facility continues on schedule, and we expect to initiate in-house GMP manufacture in the fall of 2019 for clinical supply of our off-the-shelf iPSC-derived cell product candidates.

Also, we announced a number of important leadership additions, including the appointment of Dr. Sarah Cooley as Senior Vice President, Clinical Translation, Dr. Wayne Chu as Vice President, Clinical Development, and Dr. Karen Jooss as member of our Board of Directors. I am pleased with these and many other additions to the Fate team and want to thank both existing and new Fate team members for their outstanding execution and unwavering commitment to delivering transformational change in patient outcomes.

Turning to our financial results, for the first quarter ended March 31, 2019, Fate Therapeutics incurred a net loss of $19.8 million, or $0.30 per common share, as compared to a net loss of $14.1 million, or $0.27 per common share, for the same period last year. Revenue was $2.6 million for the first quarter of 2019, compared to $1 million for the first quarter of 2018. Revenue was derived from the company's collaborations with Ono Pharmaceutical and Juno Therapeutics. Note that the four-year research term under the Juno agreement concluded as scheduled on May 4, 2019, and as a result, no additional revenue is expected to be recognized from Juno following the expiration of the agreement.

Research and development expenses for the first quarter of 2019 were $17.7 million, compared to $11.5 million for the same period last year. The increase in our R&D expenses was primarily attributable to an increase in employee compensation, including share-based compensation associated with the growth in head count to support the advancement of the company's product pipeline, third-party expenses associated with the preclinical and clinical development of the company's product pipeline, and equipment, materials, and supplies associated with the preclinical and clinical development of the company's product pipeline.

G&A expenses for the first quarter of 2019 were $5.4 million, compared to $3.6 million for the same period last year. The increase in our G&A expenses was primarily attributable to an increase in employee compensation, including share-based compensation.

Total operating expenses were $23.1 million for the first quarter of 2019. After adjusting for non-cash stock-based compensation expense of approximately $3.9 million and quarterly cash research payments from Juno Therapeutics of $500,000, our total adjusted operating expenses were $18.7 million for the first quarter of 2019. At the end of the first quarter of 2019, cash and cash equivalents were approximately $183 million, common stock outstanding was 65.1 million shares, and preferred convertible stock outstanding was 2.8 million shares, each of which is convertible into five shares of common stock under certain conditions.

...

With that, I'd like to open up the call to any questions. Thank you.

Questions and Answers:

Operator

Thank you. Ladies and gentlemen, at this time, if you have a question, please press *1 on your touch-tone phone. If your question has been answered or you would like to remove yourself from the queue, you may press the # key. To prevent any background noise, we ask that you please place your line on mute once your question has been stated.

Our first question comes from David Nierengarten of Wedbush. Your line is open.

David Nierengarten -- Wedbush Securities -- Managing Director

Hey. Thanks for taking my question. I had a couple questions. First, you mentioned I believe, unless I missed something, the combination [inaudible]. You had two different antibodies with a FT516/CD16 construct. Have you looked at sequentially, as a tumor pre-chronically gained resistance, adding the second antibody in later if that's possible? And then the second part of that is as you open the study of FT516 plus approved antibodies, is there any potential or investigator ability to do that in patients if they were to lose sensitivity or CD20 or CD19 antigens, would you be able to treat the patient with the next antibody, shall we say, along with NK 516? Thanks.

Scott Wolchko -- Chief Executive Officer and President

So, you're touching on something that is absolutely fascinating and speaks to the versatility of the CD16 receptor. Last question first, so clinically, the clinical protocol currently allows for the administration of a single monoclonal antibody to engage the CD16 receptor, and so you would not, for instance, under the clinical protocol as currently written have the ability to, for instance, give a first-let's pick an anti-CD20 monoclonal antibody, and then treat with a second monoclonal antibody. That is something that is very interesting clinically but is not part of the existing first generation clinical protocol if you will.

Preclinically, as you can imagine, we have absolutely looked at scenarios where you can utilize a product candidate like FT516 and combine with either sequentially or concurrently multiple different antibodies, and you have the ability to hit multiple different antigens by leveraging multiple different antibodies. It is one of the most powerful features of the CD16 receptor.

David Nierengarten -- Wedbush Securities -- Managing Director

And I guess maybe the quick follow-up would be have you seen differences in activity or response rates in at least the animal models with sequential or concurrent administration? Thanks.

Scott Wolchko -- Chief Executive Officer and President

So, I'm not gonna speak to that on this call. It's something that we will be presenting data around that because it is something that is very exciting and unique to the CD16 receptor.

David Nierengarten -- Wedbush Securities -- Managing Director

Okay. Thank you.

Operator

Thank you. And our next question comes from Edward Tenthoff of Piper Jaffray. Your line is open.

Edward Tenthoff -- Piper Jaffray-Biotech Equity Research Analyst

Great. Thank you. Can you hear me OK?

Scott Wolchko -- Chief Executive Officer and President

Yes, I can.

Edward Tenthoff -- Piper Jaffray-Biotech Equity Research Analyst

Great. So, Scott, thanks for the update. Really fantastic stuff and really getting exciting. I wanna ask kind of a high level question that as we get these iterative knock-ins, knock-outs, where does this ultimately go? Do we have first and even second-generation NK and/or CAR T products that may be evolved as a cancer evolves? Is this something where maybe we have something for different types of hematologic cancers and something for different types of solid tumors? Where do you ultimately see this technology evolving?

Scott Wolchko -- Chief Executive Officer and President

I think-and I think this speaks more broadly than just Fate's technology, but I do think the ability to, for instance, give multiple doses and hit multiple antigens and potentially actually secrete pharmaceutical elements is ultimately where this field will go. Cells obviously have the ability to engage specific targets, but these cells that we and others are developing have the ability to serve as factories, if you will, and secrete other elements, non-targeting elements, that absolutely can have an anti-cancer role and deliver additional functionality.

So, I do think ultimately -- and we are getting there, quite frankly, with FT596 -- a version of what we just talked about with David with respect to FT516 where you can combine FT516 with multiple different monoclonal antibodies to deliver multifunctionality, but FT596 has now actually embedded multifunctionality into the actual product candidate. We have three different functional features in that product candidate. And so, I do believe the world of cell therapy is going toward directionality where there will be multiple pieces of anti-tumor functionality embedded into these product candidates. And so, for us, one of the things we're most interested in, like, for instance, CD16, is being able to embed functionality into the backbone of cells that provide a tremendous amount of versatility.

Dan Shoemaker -- Chief Scientific Officer

And Ted, this is Dan. Keep in mind that we're already at three edits with FT596, and I think one of the differentiating aspects about this platform is because there's a cell line on the front end, it really opens the door to these complex multistep editing procedures that it's gonna allow us to go to 5-6-7 edits, and I think when you try and imagine those types of genetic engineering strategies performed on batches of cells, it really becomes challenging and nearly impossible. So, I think this is one of the major strengths of our platform that we're already realizing and we'll take advantage of even more so as we move forward.

Edward Tenthoff -- Piper Jaffray-Biotech Equity Research Analyst

Very, very interesting. Very enticing. One quick question. Is it possible to tease out activity, i.e. NKG2D versus CD19 versus therapeutic antibody, or do you even care at the end of the day? You just want response. Thanks so much for answering the questions.

Scott Wolchko -- Chief Executive Officer and President

So, again, building off something Dan said, you actually can tease out the individual functional elements by using -- essentially, think of an iPS cell as almost like a Lego where you can build the first piece of functionality in, lock in that cell line, use that cell line to add now the second piece of functionality, lock in that cell line, and now add in a third piece of functionality, and lock in that cell line. And so, now I have three generations all originating from the original master cell line where you can race those product candidates against each other and really tease out the individual component functionality. It's actually what we do do.

Dan Shoemaker -- Chief Scientific Officer

And preclinically, you can really address each of the functional elements individually. I take your point when you go to the clinic, you really have the benefit of all of them working together, and it's hard to know who's exactly doing what other than you have a multifaceted attack.

Edward Tenthoff -- Piper Jaffray-Biotech Equity Research Analyst

Very cool stuff. Thanks for the update, guys.

Operator

Thank you. And our next question comes from Biren Amin of Jefferies. Your line is open.

Biren Amin -- Jefferies -- Managing Director

Hi, guys. Thanks for taking my questions. Scott, so on the FT596 program, which is CD19-targeted CAR NK, what tumor type are you gonna go into? I read the press release. Clearly, you're expecting interim data by the end of the year, so just trying to understand which tumor settings you would go into for that program.

Scott Wolchko -- Chief Executive Officer and President

So, I think in the press release, we said that we would have initial clinical data around FT596, but we're looking at FT596 initially looking toward lymphomas.

Biren Amin -- Jefferies -- Managing Director

Got it. And is there any read-through on the FT500 program? So, I guess for FT500, are you staggering patient enrollment to follow safety? And if so, can you use that dataset and apply it FT516 and FT596 to potentially expedite clinical enrollment?

Scott Wolchko -- Chief Executive Officer and President

So, really interesting suggestion. I can't speak to that yet, although I think our hope would be that obviously the experience we're building with first products like FT500 or FT516 will be viewed potentially favorably given that there is human experience with some of those elements. So, obviously, FT500 is the first iPS-derived NK cell product. FT516 will introduce a CD16 targeting element, and FT596 will also incorporate that targeting element. So, we have certainly not pressure tested whether or not we can accelerate clinical development, but I do think the way our product candidates are rolling out, you are seeing additional functionality being built into the next generation product that is appearing in earlier generations.

Biren Amin -- Jefferies -- Managing Director

Got it. And I guess the other question I had is on FT500. When can we get efficacy data from this program? You've cleared three patients, you're going onto combination. Is this something that we could expect at the SITC meeting later this year?

Scott Wolchko -- Chief Executive Officer and President

I think our objective would be able to provide a fuller clinical update. Clearly, we will continue to provide updates along the way on progress, and safety, and biomarker observations, but yes, we are targeting a full clinical update on the program around the SITC/ASH time frame certainly.

Biren Amin -- Jefferies -- Managing Director

Great. Thank you.

Scott Wolchko -- Chief Executive Officer and President

Sure.

Operator

Thank you. And our next question comes from Daina Graybosch of SVB Leerink. Your line is open.

Daina Graybosch -- SVB Leerink-Managing Director

Hello. Thank you.

Scott Wolchko -- Chief Executive Officer and President

Hi.

Daina Graybosch -- SVB Leerink-Managing Director

A couple questions. The first one is around the lympho-depletion. I know you said the FT500 is in the outpatient. I wonder if you could talk more about the conditioning regimen, if you think it limits you to certain healthy patient population, whether you need to repeat it before each cycle, and whether that could limit the number of cycles you give?

Scott Wolchko -- Chief Executive Officer and President

Sure. I mean, I can speak to it. Dan will speak to it too. So, if you remember back to our NK100 experience, which is a donor-derived cell therapy that is ongoing in multiple Phase 1 studies, one of the benefits of the NK100 experience is we are looking at multiple different conditioning regimens ranging from complete lympho-depletion in the AML to very light lympho-conditioning in the solid tumor study. If I recall correctly, the DIMENSION study has two days of cy and one day of flu actually, and so it was very much outpatient in that setting. So, we're learning a lot from the different conditioning regimens and how those conditioning regimens are, for instance, releasing cytokines, which may be important to the cell therapy that were being delivered.

The clinical studies that we're conducting with the FT500 series of products, we are providing conditioning, and I think the FT500 study is two days of cy, two days of flu. We are providing conditioning at the beginning of the first cycle. So, not at the beginning of each dose, but at the beginning of the cycle.

Dan Shoemaker -- Chief Scientific Officer

And again, as Scott said, this is an interesting balance we're trying to get creating the optimal environment for our [inaudible] transferred cells, but we're also trying to keep in mind that one of the goals is to engage and adapt to the mean response from the patients, and so I think finding this balance is gonna be the key, and we're doing extensive biomarker analysis of both the response of the patient's immune system as well as the persistence of our iPSC-derived product in addition to the cytokine environment that we think is playing a critical role. So, it's really gonna be a balance of these factors that is gonna drive the optimal conditioning regimen and is probably gonna be slightly different for different disease indications, and this will be something that we track carefully moving forward.

Scott Wolchko -- Chief Executive Officer and President

But with respect to your comment, with respect to limitation, keep in mind the NK100 experience, we've given two doses to multiple patients. And each dose in that instance was preceded by a new cycle of conditioning. And so, the degree of conditioning we're giving, which is very light lymph-condition, I don't view as being limiting in any way to a multicycle paradigm.

Daina Graybosch -- SVB Leerink-Managing Director

Got it. Thank you. And one more theoretical question in line with some that the other analysts have asked you around the multifunctional elements, and totally appreciate that you guys with the induced pluripotent stem cell platform are uniquely positioned, I think you said to do 5-6-7-8-9 different edits, and I think this leads you --

Scott Wolchko -- Chief Executive Officer and President

Dan said that.

Daina Graybosch -- SVB Leerink-Managing Director

This leads you potentially to a really rapid cycle of product development to take something from tech. How are you thinking about versions, and what ultimately will be the commercial product?

Scott Wolchko -- Chief Executive Officer and President

So, I think it's a great question, and I think this is something that we certainly face given the robustness of our platform, and it is faced by the industry. You're seeing first generation CAR T-cell products that are targeting a single antigen potentially being rapidly displaced by product candidates that can hit multiple antigens. And so, this is a really interesting dynamic that is going on right now in the world of cell therapy. I think we're gonna think very thoughtful about evolving our product candidates. I would say the product candidates that we are developing, FT500, FT516, and quite frankly FT596 at the end of the day, our therapeutic strategy is truly very different patient populations. So, I don't necessarily envision FT500, FT516, FT596 converging into a single product candidate, although some of them, for instance the CD16 receptor is in two product candidates. But each product candidate is really being developed individually, although we are absolutely learning from the benefits that we can gain from the other product candidates in our platform, absolutely.

There's two different ways that I sort of think about the product candidates we're developing. There are backbone features, if you will, that you could imagine might be in every single product candidate, and then there are tumor-specific or cancer-specific features that may be incorporated to go after a specific type of cancer. And again, I think we are uniquely positioned to incorporate both those types of functional elements.

Daina Graybosch -- SVB Leerink-Managing Director

Great. Thank you.

Operator

Thank you. And our next question comes from Jim Vertino of Wells Fargo. Your line is open.

Nick -- Wells Fargo -- Analyst

Good afternoon. It's Nick in for Jim this afternoon. And Scott, lots of progress. Well done.

Scott Wolchko -- Chief Executive Officer and President

Thank you.

Nick -- Wells Fargo -- Analyst

First question is -- and this may be a moving target -- but what is the shelf life of your iPSC-derived products?

Scott Wolchko -- Chief Executive Officer and President

That's an awesome question. Let me be clear, shelf life, do you mean how long we can keep a product stable and cryopreserved, or do you mean, for instance, the durability within a patient?

Nick -- Wells Fargo -- Analyst

No, no. The former.

Scott Wolchko -- Chief Executive Officer and President

The former? So, for instance, as an example, we've had master cell lines, including on the research side but certainly now on the clinical side, that have been on stability testing for multiple months now in the case FT500, but if you go back and you look at master cell lines that we created, quite frankly, four or five years ago and cryopreserved, we see absolute stability and functionality post-thaw. So, that's not something I am overly concerned about being able to maintain a master cell line or even a product candidate in a cryopreserved state and then maintain high degree of viability and functionality post-thaw. I guess the thing I would point to that exists out there in the world, as you know, core blood units, as an example, are stored cryopreserved for 10-15 years and are highly effective post-cryo thaw.

Nick -- Wells Fargo -- Analyst

And then for FT596 and FT819, is the SCFP being used for the CARs fully human for those products? And if so, how does it compare to FMC63?

Scott Wolchko -- Chief Executive Officer and President

We've not discussed the design specifically. It's not fully human.

Nick -- Wells Fargo -- Analyst

And then for FT516, is this undergoing product release? And if you can hopefully file the IND by middle of the year, you're a long way along. Do you require some sort of functional readout of CD16 so these extra engineering steps that you're putting in, do you have to do release testing that proves what you've done has the functionality you want?

Scott Wolchko -- Chief Executive Officer and President

So, I'm not gonna comment on what our specific release criteria are for individual product candidates. I will say that we do do absolutely potency testing on post-cryo thawed products, both for viability and potency, and as you know, Nick, I mean, it is challenging in the world of cell therapy to maintain a high degree of viability and potency after a product has been cryopreserved. And I think one of the major accomplishments that we've been able to achieve which often goes overlooked but is critical to an off-the-shelf paradigm is being able to effectively cryopreserve cells and then have them be very viable and potent post-thaw. Our release conditions mandated, obviously, by regulatory authorities is that we demonstrate high degree of viability and potency post-thaw.

Nick -- Wells Fargo -- Analyst

Great. Thank you very much and look forward to further updates.

Operator

Thank you. And I have no other questions in the queue. I'd like to turn the call back over to Mr. Scott Wolchko for closing remarks.

Scott Wolchko -- Chief Executive Officer and President

Great. Thank you so much, everybody, for participating in today's call, and we look forward to speaking with you shortly over the next coming months.

...

Operator

Ladies and gentlemen, thank you for your participation in today's conference. You may now disconnect. Everyone have a wonderful day.

Duration: 49 minutes

Call participants:

Scott Wolchko -- Chief Executive Officer and President

Dan Shoemaker -- Chief Scientific Officer

David Nierengarten -- Wedbush Securities -- Managing Director

Edward Tenthoff -- Piper Jaffray-Biotech Equity Research Analyst

Biren Amin -- Jefferies -- Managing Director

Daina Graybosch -- SVB Leerink-Managing Director

Nick -- Wells Fargo -- Analyst

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