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Forty Seven Inc (FTSV)
Q3Â 2019 Earnings Call
Nov 12, 2019, 5:00 p.m. ET
Contents:
- Prepared Remarks
- Questions and Answers
- Call Participants
Prepared Remarks:
Operator
Good morning. And welcome to Forty Seven's Third Quarter 2019 Financial Results Conference Call. [Operator Instructions].
This call is being webcast live on the Investors section of Forty Seven's website at www.fortyseveninc.com. [Operator Instructions] Following the formal remarks, we will open up the call for questions.
At this time, I would like to turn the call over to Michael Horowicz with Stern Investor Relations.
Michael Horowicz -- Stern Investor Relations
Thank you. This morning, Forty Seven issued a press release detailing its third quarter 2019 financial results, along with anticipated future milestones and recent accomplishments. The release is available on the Investors section of the Forty Seven's website at www.fortyseveninc.com.
Today's call will begin with prepared remarks by Dr. Mark McCamish, Chief Executive Officer of Forty Seven; and Ann Rhoads, Chief Financial Officer of Forty Seven. Then we will open the call for questions. Dr. Chris Takimoto, Chief Medical Officer; Dr. Mark Chao, Founder and Vice President of Clinical Development; and Mukul Agarwal, Vice President of Corporate Development are also on the call and will be available for questions.
Before we begin, I would like to remind everyone that statements we make on this call will include forward-looking statements. These statements are subject to risks and uncertainties that could cause actual results to differ. A description of these risks can be found in our most recent periodic reports filed with the SEC. Any forward-looking statements are made only as of today's date, and we undertake no obligation to update these forward-looking statements to reflect subsequent events or circumstances.
I would now like to turn the call over to Mark.
Mark McCamish -- President and Chief Executive Officer
Thanks, Michael. Good morning, everyone. And thank you for joining us today to review our third quarter 2019 financial results and recent business highlights, which we announced earlier today. In the third quarter, we continue to progress toward our goal of delivering safe, well tolerated and effective treatments to patients and disease areas of high unmet need. As you know, our lead product candidate magrolimab, previously known as 5F9 is an anti-CD47 antibody, which aims to turn off an abnormal cells upregulated do not eat me signal, thus enabling macrophages, the innate immune systems first responders to effectively initiate an immune cascade and promote abnormal cell killing and long-term defense.
During the quarter, we achieved meaningful progress across our pipeline, including our earlier-stage programs that target other components of the CD47 pathway. Alongside magrolimab, we are advancing FSI-189, our anti-SIRPa antibody, and FSI-174, our anti-cKIT antibody -- in order to explore additional opportunities to more fully exploit the CD47 pathway as a novel therapeutic target.
On this morning's call, I will highlight that progress across two of our pipeline candidates magrolimab and FSI-174. And we'll also remind you of upcoming next steps for each program. Beginning with our lead candidate magrolimab, in the third quarter, we focused on preparing to initiate our first potential registration enabling trials in myelodysplastic syndrome or MDS and Diffuse Large B cell Lymphoma, or DLBCL. Following recent interactions with the FDA, we believe we have plans in place for both programs, which could allow us to achieve accelerate approval and to address the unmet needs of substantial patient populations.
On today's call, I want to provide an update on these plans and also elucidate what we consider to be the market opportunity for magrolimab in MDS and DLBCL, two of the hematologic malignancies with the highest burden of disease as measured by both annual incidents and mortality.
Let me start with MDS. In the second quarter, we announced that we expect to take a two-part approach to securing potential approval. First, we are expanding our ongoing Phase 1b trial, which uses a weekly dosing regimen of magrolimab in combination with azacitidine to approximately 90 patients with untreated intermediate to very high risk MDS to accelerate the acquisition of 12 months safety data.
We continue to enroll patients in this ongoing single-arm trial and the primary endpoint of that trial is overall response rate with durability response. We are also working with the FDA under a special protocol assessment to finalize key parameters of our second trial, which will use a more convenient two-week dosing regimen to evaluate the combination of magrolimab and azacitidine in MDS patients.
We expect to complete enrollment of our first trial in the third quarter of 2020 and to initiate our second MDS trial in the first quarter of 2020. In parallel, we are moving forward with chemistry, manufacturing and controls or CMC activities to support an expected filing of the BLA in the fourth quarter of 2021. Our confidence in magrolimab and azacitidine in combination is void by the data that continued to emerge from our ongoing Phase 1b clinical trial.
As we announced last week, we'll be presenting additional data from our ongoing trial at the 61st American Society of Hematology or ASH Annual Meeting. These data include additional efficacy and durability data for a larger number of patients. We're encouraged to see that the response rate we presented at ASCO in June, 2019, continued to hold overtime with 54% of untreated MDS patients achieving a complete response.
These data are particularly exciting and what they mean for patients living with MDS. While the MDS affects thousands of people, a vast majority go untreated. Approximately, 75% of patients receive only supportive care or watchful waiting due in large part to the limited number of safe and tolerable therapies available. Patients can choose to undergo allogeneic stem cell transplant, which as you know is a risky and complicated procedure or they can try Vidaza, Dacogen or Revlimid, but these offer an unattractive risk benefit profile and low rates of response.
With magrolimab, we believe we have the potential to offer the first new therapy in over 13 years with a treatment that thus far is well-tolerated and effective. We're excited about the opportunity and look forward to providing additional detail on our Phase 1b clinical trial results and our future plans around ASH next month.
Turning to DLBCL, as you know, following receipt of FDA guidance, we are planning to initiate a single-arm trial of magrolimab in combination with rituximab in heavily pretreated DLBCL patients, with primary endpoints evaluating overall response rate including PRs and CRs with durability response. In this trial, we plan to enroll approximately 100 patients who have failed at least two prior lines of therapy, which could include, but is not limited to patients who are ineligible for CAR-T therapy.
In line with previous guidance, we expect this trial to begin enrollment in the first quarter of 2020, and expect that we'll be in a position to report interim efficacy data by the fourth quarter of 2020. In parallel, we'll continue to evaluate biomarkers for options to advance into earlier lines of treatment. As you've heard us describe before, there remains a substantial unmet need in DLBCL, even despite recent approvals.
This is especially true in relapse refractory setting, where there is still positive options that can be tolerated by fragile, elderly or rapidly progressing patients. Like in MDS, there's a clear and compelling need for safe, well-tolerated and effective therapy for people with DLBCL and we're committed to moving magrolimab forward as an effective option in this population as our lead focus for approval in DLBCL.
To expand in earlier lines of treatment, we continue to explore biomarkers for potential predictive value and several triplet regimens in partnership with large pharma companies. Importantly, the FDA has granted magrolimab Fast Track designation for the treatment of both MDS and DLBCL, which believe speaks to encouraging efficacy data to date and the urgent need for safe and well tolerated new treatment options for these underserved patient populations. We believe that magrolimab mechanism of action couples with it's combinability with our other -- with other immunotherapies and oncolytics and favorable safety profile offers a unique product profile with the potential to transform the treatment of cancer and empower patients to better fight their disease.
I want to briefly comment on our programs in solid tumors. We recently submitted abstracts that include data from our ongoing Phase 1b trial of magrolimab in combination with avelumab in patients with brain cancer, and our Phase 1b trial of magrolimab in combination with cetuximab in patients with colorectal cancer to major meetings that will occur in the first quarter of 2020.
At those meetings, we plan to announce initial data from both studies at the time of those presentations. Alongside, all of these important efforts, we are continuing to advance our pipeline assets, FSI-174, which targets cKIT and FSI-189, which targets SIRP-alpha toward the clinic and we remain on track to initiate Phase 1 trials of both next year.
Earlier today, we announced our entrance into a collaboration with bluebird bio to evaluate our antibody based regimen, which is comprised of FSI-174 magrolimab, with bluebird's LentiGlobin gene therapy platform for treatment of diseases that can be corrected with transplantation of autologous gene-modified blood-forming stem cells.
This partnership represents a critical step toward our own cKIT program and we are excited to work with bluebird, a leader in gene therapy to evaluate opportunities to improve pre-transplantation conditioning. As you know, most ex-vivo hematopoietic stem cell transplant and gene therapies require that a patient's own stem cells first be depleted from the bone marrow to facilitate engraftment of the new hematopoietic stem cells or HSCs through a process called conditioning.
This process typically requires the use of chemotherapy with or without radiation exposure, which can induce sterility, acute infections, prolonged hospitalizations and increased risk of emergence of secondary malignancies. It is our hope that our novel antibody base conditioning regimen, which requires neither chemotherapy nor radiation, could avoid these toxicities.
Our scientific founders observed that blood-forming stem cells, which uniquely express cKIT can be targeted by FSI-174. Once FSI-174 binds HSC's co-treatment with magrolimab, releases macrophages to attack and clear these stem cells. Based on these observations coupled with the results of preclinical studies, we believe the combination of FSI-174 and magrolimab could offer an important and improved conditioning regimen, with more selective and short-term antibody mediated clearance of HSCs. It is our hope that this could massively expand the number of patients eligible for transplantation and therefore enable many more people to benefit from a curative potential transplantation.
At ASH, we will be presenting a poster, including new preclinical data for FSI-174. This poster details the results of non-human primate studies in which we observed that the combination of magrolimab and FSI-174 significantly depletes the frequency of bone marrow HSCs compared to placebo with no change in peripheral blood cell counts, over the course of the study.
We believe these data demonstrate the specificity, efficacy and safety of the combination in a highly relevant preclinical model. Based on these results, we are eager to initiate our Phase I healthy volunteer study of FSI-174 early next year and then start our combination trial with bluebird. If successful, we hope to expand beyond genetic blood disorders to other transplant settings such as allogeneic and other tumors.
With that I will turn it over the call to Ann to review our financial results for the third quarter of 2019.
Ann D. Rhoads -- Chief Financial Officer
Thanks, Mark. We ended the third quarter of 2019 with cash, cash equivalents and short-term investments of $166.7 million compared to $139 million as of December 31, 2018. This increase reflects aggregate gross proceeds of approximately $86.3 million from our underwritten public offering of common stock that closed in July of 2019, as well as an approximately $15.7 million upfront license payment from our entry into a collaboration with Ono Pharmaceutical. We believe we are sufficiently funded to support our planned operations and capital expenditures through the end of the first quarter of 2021, which is beyond anticipated interim data readouts from almost all of our ongoing clinical trials, while also investing in our earlier stage pipeline.
Now turning to the third quarter 2019 income statement. During the third quarter, we recognized $15.7 million in revenue due to the license granted under the Ono agreement. We did not record revenues in the third quarter of 2018. Also during the third quarter, we incurred $27.1 million in research and development expenses compared to $18 million for the same period last year. This was primarily due to a $9.2 million increase in advancing our current clinical programs focused on magrolimab and the associated contract manufacturing costs for our BLA enabling studies. A $3.2 million increase in preclinical program costs, a $1.5 million decrease in funding recognition under the California Institute for Regenerative Medicine and Leukemia and Lymphoma Society grants, as well as a $1.1 million increase in personnel-related costs, partially offset by $5.9 million decrease in license fees, primarily due to the non-recurring license fees paid under the BliNK asset purchase and Synthon license agreements in 2018.
Our general and administrative expenses were $5 million for the third quarter of 2019 compared to $4.4 million for the third quarter of 2018. This increase was primarily due to $400,000 increase in personnel and corporate related costs, driven by an increase in head counts. Our net loss for the quarter was $15.1 million or $0.38 per share as compared to a net loss of $21.7 million or $0.71 per share for the third quarter of 2018.
With that, I'll now turn the call over to the operator for questions.
Questions and Answers:
Operator
[Operator Instructions] Our first question comes from Michael Schmidt of Guggenheim Securities. Your line is open.
Charles Zhu -- Guggenheim Securities -- Analyst
Hey guys, this is Charles Zhu on for Michael Schmidt. Thanks for taking the questions and congrats on the progress. First one from me, within MDS, what kind of a patient subtype breakdown for example between intermediate or a very high risk patients would you expect within these trials and could the benchmark for approval change based on set breakdown?
Mark Chao -- Founder and Vice President of Clinical Development
Hi, this is Mark Chao. Thanks for the question. So we won't be as we've reported at ASCO, but we'll be reported in ASH, our breakdown of patients enrolled that are intermediate, high and very high risk by RpsF criteria, which constitutes our breakdown of entry criteria. Per prior discussions, we have seen a very balanced enrollment for both intermediate all the way up to very high risk and notably, these in our previous presentations, we have had a fair percentage of patients with core cytogenetic risk factors too, which is a key predictor of core prognosis. With regards to potential approval, again, we believe that this criteria as well as based on our FDA discussions to sufficient for potential registrational population and for anticipate that this in our inclusion criteria would be the centering for in our registrational studies.
Charles Zhu -- Guggenheim Securities -- Analyst
Got it. Makes sense. Could you also remind us why you're looking at both the twice weekly in addition to the once weekly dose and the degree to which you'll need data from both trials or if you have an approval pathway based on one of those trials? Thank you.
Mark McCamish -- President and Chief Executive Officer
Hi Charles, this Mark McCamish. This relates to the ongoing experience we've had with AML transitioning into MDS. And with AML, we used weekly dosing as these patients were in the hospital very often for transfusions and other treatments. As we have been progressed to MDS, these patients are less often in the hospital and using a less frequent dosing is going to be much more convenient. We want to be able to provide the best option for these patients to be able to penetrate the market and benefit them.
So we are transitioning to the every two-week dosing in our second trial. So that we have the option of using that in the commercialization of this product, which we feel will allow us to penetrate a larger segment of the market population. We've already looked at pharmacokinetic evaluations of this overtime and this is very similar to the dosing that we'll be using in DLBCL. So we're very comfortable with using that to every two-week dosing.
Charles Zhu -- Guggenheim Securities -- Analyst
Understood. Thanks for taking the questions.
Mark McCamish -- President and Chief Executive Officer
Thanks, Charles.
Operator
Our next question comes from Matthew Harrison of Morgan Stanley. Your line is open.
Joseph Lockey -- Morgan Stanley -- Analyst
Hi, thanks for taking our questions. This is Joe on for Matthew Harrison. My first question is, could you give us an idea of how many more patients and what kind of duration to expect at ASH from the MDS cohort?
Mark Chao -- Founder and Vice President of Clinical Development
Sure. Thanks for the question. So with the ongoing Phase 1b study, we're continued to be pleased about the robust enrollment and excitement, we've seen with our investigators, because again, patients are continuing to enroll and as well as our intention to want to talk to the most recent data and we won't be providing separate data right ahead of the ASH oral presentation. Because of that is, we're not able to provide exact guidance numbers on patients and follow-up time, but we will have additional patients from what's presented at the initial ASH abstract that was released last week. I will also say that, as we grow our data set, we will also be looking at patients sub analysis. I wish we started to look at mutational or responses by mutational subtypes that which we highlighted CD53. So we will continue to provide such data at the ASH presentation.
Joseph Lockey -- Morgan Stanley -- Analyst
Okay, great. How about the duration?
Mark Chao -- Founder and Vice President of Clinical Development
Yes. So we will be following these patients obviously for longer, and that will be another key output. Again it's because patients are enrolled continuously, it's hard for us to be able to predict an exact duration of follow-up, but we do believe that's a key important factor when we provide an update on our patients that have enrolled.
Joseph Lockey -- Morgan Stanley -- Analyst
Okay, thank you very much. My second question is could you give us any guidance around the process with SPA for the second MDS pivotal study. Basically what is the level of progress with the FDA and how many issues remain that you need to clarify?
Mark McCamish -- President and Chief Executive Officer
Yes. We've been having an ongoing discussion with FDA under the special protocol assessment provision and that involves both teleconference calls as well as in person meetings with them. And as you can imagine, there are several components that we're discussing, including primary endpoint, justification as well as the potential of the effects of magrolimab in monotherapy as well as rituximab and -- excuse me, azacitidine in monotherapy. So with those, there's pretty good historical preference information about aza in monotherapy, less information about magrolimab in monotherapy. And so we're discussing those issues as well as how we provide data around that. So it's an ongoing discussion, and we expect that to be wrapped up in the next quarter or so.
Joseph Lockey -- Morgan Stanley -- Analyst
Okay. Thank you very much.
Mark McCamish -- President and Chief Executive Officer
Thank you.
Operator
Our next question comes from Mara Goldstein of Mizuho. Your line is open.
Mara Goldstein -- Mizuho -- Analyst
Great. Thank you for taking the questions. The first question on the DLBCL trial, and you indicated that you sort of completed the inclusion and exclusion criteria for those patients. Can you provide us with a little bit more color around what would constitute these CAR-T ineligible patients within the context of the population you plan to enroll? And then secondarily on the bluebird collaboration, can you just speak to the dosing mechanism around the -- your combination of magrolimab and cKIT?
Chris Takimoto -- Chief Medical Officer
So Mara, thanks for the question. In regards to your question about the eligibility criteria for the DLBCL study, just to be clear, we are not mandating that patients be CAR-T ineligible, as we go forward.
Mara Goldstein -- Mizuho -- Analyst
Right.
Chris Takimoto -- Chief Medical Officer
But we are including patients who may be CAR-T ineligible, and then we will be collecting the reasons why they are CAR-T ineligible. We know from our past Phase 2 experience that there are a variety of reasons that range from medical reasons for being unfit versus things like socioeconomic insurance reasons, geographic reasons as well. But we are not focusing just on a CAR-T ineligible population moving forward.
Mara Goldstein -- Mizuho -- Analyst
Right, of course. But will you be able to look at those different buckets of ineligibility, sort of medical versus other?
Chris Takimoto -- Chief Medical Officer
Yes, and that's actually something that we've looked at very closely in our current population. And we've identified that there are patients, particularly patients that are elderly and more frail who actually do benefit from our therapy. Again our favorable safety profile really actually fits quite well with that population and we have seen benefit. I would say the one population that is CAR-T ineligible that doesn't seem to benefit from therapies in general are those who are rapidly progressive and are having disease, it's progressing very rapidly and cannot wait for CAR-T therapy. But overall, we're going to be looking at this broadly.
Mark McCamish -- President and Chief Executive Officer
And then Mara on your second question regarding the dosing around cKIT, as you know, the goal here is to clear out the hematopoietic stem cells. So we dose with both 5F9 as well as the anti-cKIT. What we do is we use the priming dose initially with 5F9 followed by a therapeutic dose and that therapeutic dose is given with the anti-cKIT. And the goal is to then clear out the hematopoietic stem cells. So the anti-cKIT labels, hematopoietic stem cells then the 5F9 frees up macrophages to attack and clear those.
We're -- we've worked out the PK in non-human primates that we'll be talking about in ASH. And the important component is to ensure that you give enough to clear out the hematopoietic stem cells and then allow for those agents to be eliminated prior to transfusion of your gene modified cells. And we'll be talking about that at ASH as well. That's the primary focus.
Mara Goldstein -- Mizuho -- Analyst
All right, thanks for that.
Mark McCamish -- President and Chief Executive Officer
Thanks, Mara.
Operator
Our next question comes from Robert Hazlett of BTIG. Your line is open.
Jake Colby -- BTIG -- Analyst
Hi guys, this is Jake Colby on the line for Bert. Thanks for the question. I just wanted to follow-up on the ASH abstracts. Will you be breaking out, I guess the first 11 patients that we saw at ASH just to get a longer-term duration of follow-up. They're acknowledging that a lot of patients will be enrolled recently.
Mark Chao -- Founder and Vice President of Clinical Development
Yeah. Jake, thanks for the question. This is Mark Chao here. I appreciate the comment. We will be detailing out again, importantly, as you mentioned follow-up for those patients and as you alluded to, since we will have recent patients enroll that may not accurately capture the duration of follow-up for those initial patients. So we will make an attempt to do that. We think that's really important and have been pleased to see at least as of the ASH abstract announcement that we continue to not see a median duration of response with additional follow-up our median wise. So those will be data will continue to present for both the initial AML patients as well as the MDS patients and new patients that come onboard.
Jake Colby -- BTIG -- Analyst
Okay, great. Thank you for that. And just to follow-up is, based on kind of your discussions with the physicians and maybe some with FDA, what do you think is a clinically meaningfully differentiated duration response or thought 5F9 is for MDS? Thank you.
Mark Chao -- Founder and Vice President of Clinical Development
Sure. So I think I'll speak to our data first. So as you know from our abstracts we presented last week, we've been pleased to see that the efficacy is continued to track. Notably, we've seen a CR rate of 54% and again seeing on regulatory endpoints as stated as CR plus PR rate we believe it's meaningful for registrational approval. With regards to in terms of what would be a clinically meaningful benefit. I think part of that from a regulatory approach as well as clinically it's being able to exclude what is azacitidine monotherapy response rates are. We've guided that at least in the 2004 label for a decided in an MDS, that's the CR plus PR rates were 16%, which is fairly low. And so we believe that provides a bar of comparison in terms of demonstrating the combination over azacitidine monotherapy.
Jake Colby -- BTIG -- Analyst
Thank you and congrats on the progress.
Mark McCamish -- President and Chief Executive Officer
Thanks, Jake.
Operator
Our next question comes from Sean Lee of HC Wainwright. Your line is open.
Sean Lee -- HC Wainwright -- Analyst
Good morning, guys. And thanks for taking my questions. My first question is on the upcoming MDS pivotal study. So I understand you're still working through the details of the SPA with the FDA, but I was just wondering, other than the change to dosing regimen, are there any additional changes proposed for the patient populations. And also has the FDA signed off on the objective response rate to see primary endpoint or are you looking for stuff like PFS as well. Thanks.
Mark McCamish -- President and Chief Executive Officer
Hi, Sean. We continue to work with the agency on this -- the population that we'll be using is no different than what we've proposed previously. So there hasn't been too much discussion regarding that. And then primary endpoints, as we've mentioned previously, combination of PR and CR, and we'll continue to discuss with them the most appropriate approach as we move those forward. I think I detailed in the answers to my two other questions, some of the issues that we're discussing. And it's not anything that's surprising in that situation, study design, number of patients, statistical approach, etc. And the major change of course is the every two-week dosing. I think with our experience and the first study and weekly dosing, I guess is quite a bit of information to be able to hone in on most important components with the agency. And that's an ongoing discussion.
Sean Lee -- HC Wainwright -- Analyst
Great. My second question is on the collaboration with bluebird. So, could you provide a little bit more color on the financial aspects of that and who will be responsible for running the upcoming Phase 1 studies next year. And also is this purely a research collaboration, or are there any options or exclusivity associated with it?
Mark McCamish -- President and Chief Executive Officer
Sure, Sean. I'll have Mukul jump in since he has worked out the agreement.
Mukul Agarwal -- Vice President of Corporate Development
Thanks, Mark. So yes, this is a research collaboration. It's for a very defined period. The research collaboration is designed around establishing a proof-of-concept for our antibody along with bluebird's gene therapy product. And so the way the collaboration would work is that each party would be responsible for its part of the research plan. For us, for CD47, it would be -- we would be responsible for the preclinical studies, the filing for the IND, and also the Phase 1 healthy volunteer study. And then bluebird would be responsible for the proof-of-concept and each party would bring it product into the collaboration and also do cost sharing as part of that.
Mark McCamish -- President and Chief Executive Officer
And as we move forward, as Mukul mentioned, we'll be doing the Phase 1 trial and that Phase 1 trial if a normal healthy volunteers with our anti-cKIT. We have copious experience with magrolimab. And this is designed as a combination program. So that you use cKIT that labels HSC and then magrolimab, which enables the macrophages to then attack. So the Phase 1 is fairly straightforward in normal healthy volunteers to confirm the PK and approach we'll be using with our anti-cKIT, allowing us to then move into combination where we'd be working directly with bluebird in their approach.
Sean Lee -- HC Wainwright -- Analyst
Thank you for the additional color. That's all I have.
Mark McCamish -- President and Chief Executive Officer
Thanks, Sean.
Operator
Our next question comes from Adam Evertts of LifeSci Capital. Your line is open.
Adam Evertts -- LifeSci Capital -- Analyst
Great, thank you. First question, I know it's difficult to comment on other company's programs, but maybe if you're willing -- it would be interesting to hear your view on the ASH abstract data from Celgene's anti-CD47, maybe what that means for the space or for magrolimab specifically.
Mark Chao -- Founder and Vice President of Clinical Development
Yes. I think Adam, this is Mark here. So we can provide a little bit of color. I think as you alluded to there were a few programs that presented updates on CD47 targeting agents one of which was Celgene, and then also another company ALX Oncology. I think overall, our viewpoint is, we continue to -- are pleased with interest in those programs. We think, again, that it validates the target. Both programs did show evidence of efficacy. I think again with regards to the Celgene data, which was interested, I think one of the things that they flag with a high rate of anti-drug antibodies that leads further abstract appeared to be affected by the PK and potential safety. So that may also be an issue with the program. I think what we can do is just comment in terms of our program. We've been quite pleased and deliberate as you know to define the most optimal, acid and molecule to balance both safety and efficacy. And so there we treated over 400 plus patients. And then really not seen any significant certain issues we've worked around the on target anemia with our primary and maintenance strategy as you know.
I think with regards to our [indecipherable] antibody rates, they have been quite low, less than 10% in our previously reported data, without any evidence of any safety issues or PK changes. So that is something that again we think is differentiating. And again I think just highlights the approach that one needs to safely and effectively target CD47.
Mark McCamish -- President and Chief Executive Officer
Yes. I think Adam, we were pleased that others are interested in the program. It does validate the target. And it just displays the experience that we've had in this with our founders that goes back over a decade, which really allowed us to make progress and anticipate some of the issues that others have run into. So I think on both of those areas, we're pleased with the emerging data and look forward to sharing our data as we go forward.
Adam Evertts -- LifeSci Capital -- Analyst
Great. And then a quick question actually on the Ono Pharmaceutical agreement, I realize this is relatively recent, but maybe if there are any updates there in terms of when Ono might start a clinical trial in Asia. And if they might participate in either the ongoing or planned studies using Asian sites.
Mark McCamish -- President and Chief Executive Officer
So let me just comment on that an overarching theme. As you know, with Ono, they're very interested in moving this forward. In general, the approach that you use in partnership with the Japanese company is to provide Phase 1 data in the Japanese population. And so that's the most urgent thing that they'll be working on is to provide information in the Japanese population that there's no differences in PK and tolerance with our agents. And then secondarily, as we've mentioned previously, one important component to both MDS and DLBCL is, how do we move forward with either confirmatory, randomized control trial or randomized control trials that we'll address, ex-US participation. And we're working with Ono collaboratively in that in terms of the approach we would take forward in MDS and DLBCL.
Adam Evertts -- LifeSci Capital -- Analyst
Thank you.
Mark McCamish -- President and Chief Executive Officer
Thanks, Adam.
Operator
Our next question comes from Tony Butler, ROTH Capital. Your line is open.
Tony Butler -- ROTH Capital -- Analyst
Thanks very much. Three very brief questions and fairly simple, number one is, Mark, just yet again a comment -- I think, the filing pathway that you've laid out for these two studies very clear. Question is, can you just speak about the EU and your thoughts there. Okay, that's number one. Number two is, I'm just curious in the healthy volunteer study with cKit, is it pretty easy. This may be a silly question is it pretty easy to an oral patients who want to be immunosuppressive with the combination of agents, and then allow just regrowth of their -- reconstitution of their immune system just naturally. That's number two.
And then number three is, more theoretical again, and this is just back to the simplicity of eat me, don't eat me signals. The question is around, Vista deficiency and does Vista play a role either -- by being deficient or in being prolific? Does it play a role in whether or not that balance between eat me and don't eat me signals exists. Thanks very much.
Mark McCamish -- President and Chief Executive Officer
Hey, Tony. This is Mark McCamish. Thanks for your questions and none are ever easy with you. So we appreciate it. So first on the EU and it's an important question. And we know that the EU is less likely to move forward with single arm approaches that are there. And we're beginning to have discussions in terms of our approach. Obviously, we're looking at this is to how do we best coordinate and expand outside of the US for commercial approaches.
And it's likely that a randomized trial would be required and that's fine, because we'll be using that for confirmation in our approaches here in the US. So we're beginning to have those discussions. And one of the issues with any type of randomized control trial is, do you simply confirm your findings or do you expand your findings? And we'll have to discuss that. If we would really like to get into lower risk MDS patients and we'll have to decide whether you do that in a joint trial with low risk and intermediate to high risk or whether you have two separate approaches to expand those labels. So it's not easy, but we're discussing those and we'll be discussing with the relative country agencies in Europe to come up with the best overall approach.
The second question was on the cKit normal healthy volunteer study. Let me just walk through that a little bit. And that is recall that anti-cKIT alone will not clear these stem cells. It just labels the stem cells with an IgG1 and our nonhuman primate data that we'll be talking about at ASH. We'll lay this out fairly, clearly. In the past, it is possible to use an anti-cKIT and to use that in immunocompromised patients and be able to clear out hematopoietic stem cells. We have found in immuno-sufficient patients that the anti-cKIT alone does not cause clearance of those HSCs. Therefore, that's the reason we use a combination.
So the normal healthy study that we'll be performing, we'll only use anti-cKIT to document the PK, safety and tolerance of anti-cKIT. We'll not use the combination of anti-cKIT and 5F9 or magrolimab in normal healthy volunteers as that would cause clearance of these normal hematopoietic stem cells and we would not want to do that in normal healthy volunteers. So we'll use the combination in patients who will then be transplanted, but we'll use FSI-174 or anti-cKIT only in normal healthy volunteers. And the third question, I'm going to have Mark Chao take a shot at that.
Mark Chao -- Founder and Vice President of Clinical Development
Yes, thanks Tony for the scientific question. So with regards to the question about, does Vista play a role? I'll just backtrack and highlight, I think one of the things that we really like about CD47 targeting with magrolimab is its ability to actually stimulate the adaptive immune system. And so as you know, we discussed before, we have preclinical and some evidence of clinical data demonstrating that upon administration of magrolimab macrophages can adjust cancer cells and present to tumor associated antigens to T-cells and activate an adaptive T-cell response. So I do think that then in that regard with other T-cell checkpoints like Vista or PD-1, there maybe a role as well. We and others have demonstrated combination data in preclinical models with PD-1, PD-L1 blockade plus CD47 blockade. So I think that's important.
And then to your question about Vista, I think there's essentially could be a role there. As you know, Vista is expressed on tumor infiltrating lymphocytes has a role on Treg cells as well. We've shown some evidence preclinically that we also can modulating down regulatory T-cell. So there is certainly it's a potential role, I think it again highlights that in addition to enabling the innate immune system, we also can enable the adaptive immune system. And then with regards to whether Vista plays a role in that, eat me or don't eat me cascade, I think that's something that still needs to be originated.
Tony Butler -- ROTH Capital -- Analyst
Thank you very much for the clarity. Appreciate it.
Mark McCamish -- President and Chief Executive Officer
Thanks, Tony.
Operator
Our next question comes from Mark Breidenbach of Oppenheimer. Your line is open.
Matt Biegler -- Oppenheimer -- Analyst
Hey, guys. This is Matt on for Mark. Thanks for taking our questions. Mark, congrats as well on the bluebird collaboration. So just one from us actually, and I apologize if I missed this in the prepared remarks. But one of the main drawbacks we commonly hear about bluebird's approach with busulfan is its effect on sexual reproduction. And we're just wondering if you could kind of shed some light or give us your expectation for whether you think your approach would be safer on gametes. Thanks.
Mark Chao -- Founder and Vice President of Clinical Development
Yes, Matt. This is Mark Chao here. Appreciate the question. So I think you bring up a really important point, is that standard conditioning regimen cytotoxics like busulfan, which is widely used for managing therapy cannot only cause kind of morbidity in a short term and potential mortality, but importantly long-term effects. So I think infertility and effects on sexual reproduction is a major issue, especially for young patients, pediatric patients that are getting gene therapy than other transplants for let's say sickle cell or beta thalassemia for example.
I think based on our knowledge, our cKit and CD47 blockade antibody based approach. We believe that this antibody combination would be safer and potentially not have those risks of infertility secondary malignancies, which again are really important for patients to determine whether they want to go for a transplant or not. So we do think that these are potential key areas of safety benefit with our antibody based combination, our conditioning regimen that will allow for patients and clinicians to have a better option to choose should our data and then share that. So thanks for the question.
Mark McCamish -- President and Chief Executive Officer
And again, Matt, this is Mark McCamish as well. We'll also have preclinical data that's required for the IND, which can include -- information and that will back up, what Mark is saying is that there's limited risk from the standpoint on this for sterility.
Matt Biegler -- Oppenheimer -- Analyst
Awesome. Looking forward to it at ASH. Thanks guys.
Mark McCamish -- President and Chief Executive Officer
Thanks, Matt.
Operator
Our next question comes from Soumit Roy of JonesTrading. Your line is open.
Soumit Roy -- JonesTrading -- Analyst
Hello, everyone. Thank you for taking the question. Just want to touch upon the expansion of enrollment criteria in the DLBCL trial. Could you just talk us through the decision making process of why you think, you could present a competitive data in that space given your Phase 1 and Phase 2 combined gives a CR of 18% versus I mean CAR-T of high-30s to 40s. Is there a reason you think that response rate could improve with certain patient group just so to understand your thought process in all that.
Mark McCamish -- President and Chief Executive Officer
Soumit, this is Mark McCamish. Let me just walk you through a little bit of this and then Chris can backup as well. So the process was involved both our Phase 1, Phase 1b and Phase 2 patients, our ongoing discussions with FDA. And what would be best for patients moving forward. And as you know, we've initiated these programs in patients, who are relapsed refractory to rituximab treatments. It's important that you understand the differences with the approach we're using, which augments ADCP versus ADCC, which is the initial mechanism for rituximab. So we can rescue patients, who have been previously treated respond to rituximab. It's also important to look at lines of treatment and how others are impacted by all of these. And we've looked at data from our Phase 1b, Phase 2 studies as well as interface with the agency. And as you can recall, when we talked with them after our initial meeting with presenting the data, they were giving us guidance regarding the approach to a single arm trial.
Our randomized control trial is not an issue, one can describe a standard of care approach we could take and move into that. However, with using a single arm trial approach, they were guiding us in terms of the patient populations that would differentiate us from other agents. And initially, they were interested in the CAR-T ineligible patient population, because they knew that this was a fairly large population and there were various reasons, one could be CAR-T ineligible. We explored that in our Phase 2 component and then have a good understanding of that. In our latest discussions with the agency and walking through this, we felt that CAR-T ineligible and using the descriptor of that was limiting. And when we looked at all of our data from the Phase 1b and Phase 2, we felt that using a definition that would be greater than two lines of CD20 treatment, regardless of whether they were CAR-T ineligible or not, would allow us to have a patient population that would be along the line of third line patients. And that would respond as we've outlined in our experience was greater than three lines of -- greater than equal three lines of treatment in that patient population.
So we've interfaced with the agency, we've looked at our data, we've looked at translational data to understand the responses that these patients would have and we think we've got a reasonable understanding of that and have agreed with the agency to move forward in that greater than second line anti-CD20 that could include CAR-T ineligible, but its not required to be CAR-T ineligible. And we think that gives us the best opportunity to have an impact on the patients that would both -- that would most respond to our agents.
Chris Takimoto -- Chief Medical Officer
Yeah. And I'll just add that in our comprehensive review of the Phase 1 and Phase 2 data. Very clearly, there were these patients that had a very strong benefit from magrolimab and rituximab. And again, many of these patients had even three or more prior lines of therapy, before coming onto our study. Many of them were primary refractory. So there's very clearly a population here that does get a very good benefit with durable responses. And our plans to move forward is to really try and capture those patients.
Soumit Roy -- JonesTrading -- Analyst
Got it. If you could just deeply remind us what percent where the CAR-T ineligibles in your Phase 1 or combined. And I have a just second question is, with regard to in the solid tumor program that we have seen the -- your peers targeting [indecipherable] clear signals in certain immune active tumor types like lung cancer type. Do you think you would focus on something more immune active types rather than ovarian and CRC, which is always a hard time with the IO agents.
Mark McCamish -- President and Chief Executive Officer
Soumit, I'm having a little bit of difficulty hearing your first question. Could you repeat that first question, please? And...
Soumit Roy -- JonesTrading -- Analyst
First one, I just wanted to ask, what percent in your Phase 1, 2 study were CAR-T ineligibles in that data set?
Chris Takimoto -- Chief Medical Officer
So I can address that. In the Phase 2 population, essentially, the vast majority, all those patients -- nearly all those patients were CAR-T ineligible, because that was the mandatory requirement. In the Phase 1 population, we did not capture the CAR-T ineligibility status there, and because CAR-T ineligibility, oftentimes, is a very subjective determination based on the treating physician. We can't give you the specific breakdowns in the Phase 1 population.
Mark Chao -- Founder and Vice President of Clinical Development
And then Soumit, this is Mark Chao here. To your second question, with regards to kind of hot or cold tumor types in the solid tumor program. So we are looking at that approach, I think, as mentioned on the call, we have programs in ovarian cancer, which is more considered cold tumor type. We do have note has a combination with tocilizumab that's run by Genentech and then a clinical collaboration in bladder cancer. And so that is, as you know, more hot active tumor type to really probe that hypothesis.
So that study is ongoing. We do think that solid tumors is in an area that's on task. And in addition, I think one of the things that we're seeing in terms of class combinations is with our data with azacitidine in other preclinical data that we see with cytotoxics or chemotherapies up regulating eat me signals and meeting to synergy. This would likely apply and we know preclinically to other chemotherapy combinations. So this may be a strategy to evaluate chemo combinations with magrolimab, especially in the solid tumor setting as well as in liquid cancers.
Soumit Roy -- JonesTrading -- Analyst
Thank you so much for taking on the questions and congrats again. Looking forward to the ASH date.
Mark McCamish -- President and Chief Executive Officer
Thanks, Soumit.
Operator
There are no further questions. I'd like to turn the call back over to Mark McCamish for any closing remarks.
Mark McCamish -- President and Chief Executive Officer
Thank you all. And operator, thank you. We really appreciate you taking the time to join us so early in the morning and for your continued support at Forty Seven. We look forward to updating you again soon. Thanks again.
Operator
[Operator Closing Remarks]
Duration: 51 minutes
Call participants:
Michael Horowicz -- Stern Investor Relations
Mark McCamish -- President and Chief Executive Officer
Ann D. Rhoads -- Chief Financial Officer
Mark Chao -- Founder and Vice President of Clinical Development
Chris Takimoto -- Chief Medical Officer
Mukul Agarwal -- Vice President of Corporate Development
Charles Zhu -- Guggenheim Securities -- Analyst
Joseph Lockey -- Morgan Stanley -- Analyst
Mara Goldstein -- Mizuho -- Analyst
Jake Colby -- BTIG -- Analyst
Sean Lee -- HC Wainwright -- Analyst
Adam Evertts -- LifeSci Capital -- Analyst
Tony Butler -- ROTH Capital -- Analyst
Matt Biegler -- Oppenheimer -- Analyst
Soumit Roy -- JonesTrading -- Analyst
