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Operator
Good day, and welcome to Affimed's Third Quarter 2018 Financial Results and Corporate Update Conference Call. (Operator Instructions) As a reminder, today's conference is being recorded.
I will now introduce your host for today's conference, Greg Gin, Head of Investor Relations at Affimed. Please go ahead, sir.
Gregory Gin - Head of IR
Thank you, operator. Thank you for joining us today for Affimed's conference call to discuss the company's third quarter 2018 financial results and operational progress, as well as the important new data contained in some of our ASH 2018 abstracts. This morning, Affimed issued a press release, which is posted on the company's website at www.affimed.com.
On the call with me today are Adi Hoess, CEO of Affimed; Leila Alland, Chief Medical Officer; and Florian Fischer, Chief Financial Officer.
We will begin today's call with opening remarks from Adi on our progress during the third quarter. Leila will follow Adi and overview the data on our programs at ASH, and then Florian will review the financials. Following the prepared remarks, we will host the Q&A session.
Before we start, let me review our safe harbor statement. Today's discussion contains projections and forward-looking statements regarding future events. These statements represent our beliefs and assumptions only as of the date of this discussion. Except as required by law, we assume no obligation to update these forward-looking statements publicly or to update the reasons why actual results could differ materially from those anticipated in the forward-looking statements, even if new information becomes available in the future.
These forward-looking statements are subject to risks and uncertainties, and actual results may differ materially from those expressed or implied in the forward-looking statements due to various factors, including, but not limited to, those identified under the section entitled Risk Factors in our filings with the SEC and those identified under the section entitled Cautionary Statements Regarding Forward-looking Statement in our Form 6-K filed with the SEC earlier today.
With that, I will now turn the call over to Adi.
Adi Hoess - CEO, MD & Member of Management Board
Thanks a lot, Greg. Good morning, everyone, and thank you for joining us. Our objective today is to highlight our quarterly progress and share the data included in some of our ASH abstract.
Our progress in the third quarter is highlighted by the important new strategic collaboration that we entered into with Genentech for NK cell engager-based immunotherapeutics, based on our proprietary CD16A targeting ROCK platform, which is all summarized on Slide 3. This partnership is a transformational accomplishment for Affimed and marks an important step forward on our path to leverage the full potential of innate immune cells in oncology.
There has been a lot of interest in the Genentech deal, so I would like to make a few comments about that. Affimed will develop novel NK cell engagers for multiple, solid and hematologic tumor targets and candidate products of interest to Genentech. We believe that this partnership represents a further validation of our ROCK platform, expertise in activating innate immunity to eliminate cancer cells and developing bispecific antibodies in unique formats and complement Genentech's deep understanding of cancer immunology and their own bispecific expertise.
This collaboration has the potential to accelerate the understanding of the role of innate immune cell engagement and activation within immuno-oncology. We plan to leverage our respective strengths to advance the development of CD16A targeting innate immune cell engagers, with the goal of achieving durable benefit for cancer patients. So we strongly believe Genentech is an ideal partner for Affimed.
Affimed and Genentech will collaborate on the discovery and preclinical development of ROCK-based antibodies, while Genentech will be fully responsible for clinical development and commercialization worldwide. The partnership is off to a great start, with strong collaboration between the scientific teams from both companies. Under this agreement, Affimed was eligible to receive $96 million in upfront and committed funding, and I'd like to mention that we have received the full $96 million payment at the end of October. In addition, we may be eligible to receive up to an additional $5 billion over time, including payments upon achievement of specified development, regulatory and commercial milestones, plus royalties on sales.
The funding from the Genentech collaboration provides an important source of nondilutive financing for Affimed, supporting further development of our own pipeline and extending our cash runway beyond the previously guided fourth quarter 2019. We plan to update our guidance on cash runway after we finalize the development path forward for April 13, including the designs of a registrational chemical study, and have more detailed information regarding the timing of future clinical activities.
One last note about the collaboration, it is specifically focused on NK cell engagers on a target-by-target basis for a specified number of targets. Beyond such NK cell engagers being developed in this partnership, we will continue to develop other innate immune cell engagers and T cell engagers from our platform for our own pipeline and in the context of other collaborations and partnerships.
Slide 4 represents an overview on the current stage of our progress. Before I turn to the data that we're going to present at ASH, I'd like to provide a short update on AFM24, our EGFR/CD16A targeting bispecific antibody, which is designed to address current limitations on other EGFR targeted agents as shown on Slide 5.
Most importantly, we selected the final development candidate and successfully completed a toxicology assessment in cynomolgus monkeys at a range of doses -- of dose levels up to 75 mg per kg over 4 weeks, with no observed toxicities even at high-dose levels. AFM24 is designed to treat patients with a variety of EGFR expressed in solid tumors, with the potential for better efficacy and safety as compared to other therapeutic and anti-EGFR monoclonal antibodies that are associated with significant toxicities. We continue to anticipate completing our IND-enabling studies by mid-2019.
Now let's shift gears and focus on the ASH data. Slide 6 provides an overview, and I'm pleased to say that this is going to be the biggest ASH ever for Affimed with 6 presentations, highlighting our innate immunity and T cell-based therapeutic programs. Together with our collaboration partners, we are looking forward to sharing updated clinical data of AFM13, showing continued promising signs of therapeutic efficacy in -- both in combination with Keytruda in Hodgkin lymphoma and as monotherapy in CD30-positive lymphoma.
I'd also like to point out 3 preclinical abstracts, one of which we'll touch on briefly today related to our relationship with the MD Anderson Cancer Center and the preclinical program of cord blood-derived allogeneic NK cells premixed with AFM13 for CD30-positive malignancies. This program with MD Anderson is part of our long-term strategy to explore rational combinations with our engagers to investigate potential of achieving more potent and durable antitumor efficacy.
Additional abstracts relating to our work on the activation of innate immunity that will be presented at ASH include an update on Affimed's research on the role of CD16A-specific immune cell engagers and activation of CD16A in expressing macrophages to eliminate tumor cells, as well as preclinical data on our partnered program for AFM26, targeting BCMA and CD16A in multiple myeloma. And we will also present data on the clinical study of AFM11 in ALL.
Before I turn the call over to Leila for the data review, let me briefly comment on our focus moving forward.
We've recently had discussions with the FDA on the AFM13 data generated to date and future development plans for April 13, including a potential path forward for accelerated approval. Based on feedback from the FDA, we're finalizing our plan for a registrational study for AFM13. We will review the clinic development strategy for AFM13 at an Investor and Analyst Event planned for December 7 in New York City. We will announce additional details closer to the date of this meeting.
Now let me hand over the call to Leila to review the data. Leila?
Leila Alland - Chief Medical Officer
Thank you very much, Adi. Let me start with a quick overview of the AFM13 clinical studies in Hodgkin lymphoma and then CD30-positive lymphoma as shown on Slide 7.
Our Phase Ib study in Hodgkin lymphoma is evaluating the safety and tolerability of AFM13 in combination with Keytruda or pembrolizumab as salvage therapy after failure of standard therapies, including brentuximab vedotin in relapsed or refractory patients.
The investigator-sponsored Phase Ib, IIa study of AFM13 in patients with relapsed or refractory CD30-positive lymphoma with cutaneous manifestation, is led by Columbia University. The primary objective of this study is to investigate the biological and immunologic effects induced by the administration of various doses of AFM13 monotherapy. The study is designed to allow for serial biopsies, thereby enabling assessment of NK cell biology and tumor cell killing within the tumor microenvironments.
Now with you oriented, I will walk through the ASH abstracts for the combination study of AFM13 with pembrolizumab. Updated data showed an 87% objective response rate and a 39% complete response rate in 23 evaluable patients from the highest dose cohort as of June 29, 2018. The combination of AFM13 and pembrolizumab was well tolerated and showed encouraging response rates versus pembrolizumab monotherapy. Updated data for all 30 patients, including the 24 patients from the highest dose cohort plus 6 patients treated at lower doses, will be presented at ASH.
Let's turn to the ASH abstract for the AFM13 monotherapy study led by Columbia University. Updated data from this study with AFM13 in relapsed or refractory CD30-positive lymphoma with cutaneous lesions showed a 50% objective response rate in 3 dose cohorts and equaled 8 patients, including one complete response, 30%; and 3 partial responses, 38%. Importantly, these data reinforce the potential single-agent activity of AFM13. Biomarker data showed respondents had increased expression of CD69, a marker of NK cell activation over time with tumor biopsies demonstrating increased infiltration of CD56-positive NK cells and decreased circulating T-regs compared to nonresponders.
As shown on Slide 8, at ASH, MD Anderson Cancer Center, our research collaboration partner, will discuss in an oral presentation the first data from experiments investigating a novel product comprised of expanded allogeneic cord blood-derived NK cells preloaded with AFM13, to redirect the specificity of NK cells against CD30-positive malignancies in preclinical models. The data provide a strong rationale for testing this combined, redirected, off-the-shelf cellular product to further increase response rates and durability of responses in patients with relapsed/refractory CD30-positive lymphoma.
Now let's turn to AFM11 on Slide 9, our CD19/CD3-targeting tetravalent bispecific T cell engager. Preliminary results will be presented at ASH on the clinical activity and safety of AFM11 in the Phase I dose-escalation study in patients with relapsed/refractory acute lymphoblastic leukemia or ALL. The data in the ASH abstracts released on November 1, 2018, showed 2 complete responses with complete hematological recovery, including one patient achieving minimal residual disease negativity.
In October, we announced that AFM11 is on clinical hold after the occurrence of Serious Adverse Events in 3 patients. Our assessment of the data from the AFM11 program is ongoing, and we're continuing to work with global health authorities to determine next steps for the program. We plan to provide an update on the AFM11 program after we've completed our evaluation.
We expect the results in the ASH abstracts that I discussed today to be updated with additional follow-up data that will be included in the respective presentations at ASH.
Now I will hand it over to Florian to review the financials. Florian?
Florian H. M. Fischer - MD, CFO & Member of Management Board
Thank you, Leila.
Affimed's consolidated financial statement has been prepared in accordance with IFRS as issued by the International Accounting Standard Board, or IASB, and is summarized on Slide 10. The consolidated financial statements are presented in euros, which is the company's functional and presentation currency. Therefore, all financial numbers that I will present here on this call, unless otherwise noted, will be in euros. Any numbers referring to third quarter 2017 and third quarter 2018 are unaudited.
Cash and cash equivalents totaled EUR 37.1 million as of December 30, 2018, compared to EUR 39.8 million as of December 31, 2017. At the end of October 2018, we received the initial upfront payment and other near-term committed funding total USD 96 million or EUR 82.9 million from Genentech. Including the payment from Genentech, pro forma cash and cash equivalents would have been -- would have totaled EUR 120 million or USD 138.9 million as of September 30, 2018.
Net cash used in operating activity was EUR 24.9 million for the 9 months ended September 30, 2018, compared to EUR 20.7 million for the 9 months ended September 30, 2017. The increase was primarily related to higher cash expenditure for research and development in connection with Affimed's clinical development programs and early-stage development activity.
Revenue for the third quarter 2018 was EUR 300,000 compared to EUR 500,000 for the third quarter 2017. Revenue in both periods was solely derived from AbCheck services.
R&D expenses for the third quarter 2018 were EUR 9.8 million compared to EUR 6 million for the third quarter 2017. The increase was primarily related to higher expenses for early-stage development and discovery activities. G&A expenses for the third quarter 2018 were EUR 2.4 million compared to EUR 1.9 million for the third quarter 2017. Net loss for the third quarter 2018 was EUR 12 million or EUR 0.19 per common share compared to a net loss of EUR 8.1 million or EUR 0.18 per common share for the third quarter 2017.
Now I'll turn the call back over to Adi for concluding remarks. Adi?
Adi Hoess - CEO, MD & Member of Management Board
Thanks, Florian.
Thanks again, everyone, for joining us today. We appreciate you following our continued progress. It is very exciting time for Affimed with the recent Genentech collaboration, the coming data updates at ASH, including 6 accepted abstracts, and as we finalize the future development plans for AFM13, including a registrational study.
Lastly, as shown on Slide 11, we hope you'll join us on Friday, December 7, in New York City, where we will host an Investor and Analyst Meeting to provide more detail and context on the future clinical development plan and strategy for AFM13.
That completes the formal part of our call, and we'll now open the call to take some questions. Operator?
Operator
(Operator Instructions) We will now take our first question from Peter Lawson of SunTrust.
Peter Richard Lawson - Director
Adi, just on AFM11, when can we see an update? What are the next steps meeting with authorities, et cetera? And then is there any color you can provide around the patients -- 3 patients who had the issues? And just a path forward, whether you can change the trial easily or restrict the particular patient groups?
Adi Hoess - CEO, MD & Member of Management Board
Thanks, Peter. I'll hand that question over to Leila.
Leila Alland - Chief Medical Officer
Thanks, Peter. So what I can say is that 33 patients have been treated in total in the 2 Phase I studies, with preliminary signs of clinical activity observed in patients in the ALL trial.
The Serious Adverse Events that were reported in the 3 patients included a death in the ALL study and 2 life-threatening events in the NHL study. The SAEs occurred in patients enrolled in the highest dose cohorts of each study. The events were initially assessed as drug-related, and each of the patients experienced signs or symptoms of neurotoxicity that occurred during or soon after completion of AFM11 treatments and, hence, were considered drug-related.
Unfortunately, one patient did not recover and died. The other 2 patients recovered from the events and were discharged home. We're working closely with the health authorities, the safety monitoring committees and importantly, the studies' clinical investigators to thoroughly review the events and carefully assess all of the data in order to fully understand the events. We will provide an update on the path forward for AFM11 upon completion of the evaluation.
Peter Richard Lawson - Director
Do you think that's a couple of month process? Or any timelines around that would be great.
Leila Alland - Chief Medical Officer
What I can say is that we're working as quickly as possible to thoroughly assess the events and to get feedback from investigators and other experts as well as some health authorities. But I can't give you a precise timeline. But I could tell you that we're working on it with our highest priority.
Peter Richard Lawson - Director
Got you. And then, Adi, just at the Analyst Day, is that to -- we did -- we should get the registrational plan for AFM13. Will we also get additional data from pipeline products? Or is it just more of a deep dive just around the pipeline, et cetera?
Adi Hoess - CEO, MD & Member of Management Board
So it's focused on AFM13 because we have invested with AFM13 in a variety of approaches. So we have different options on how we can move the drug forward. We've just mentioned the exciting data that we can present at ASH. One is a monotherapy in CD30-positive lymphoma and another is a potential or is the combination of AFM13 with Keytruda. And on top, we have exciting preclinical data that showed that AFM13 can be used in combination with adoptive NK cell transfer.
So this will be the focus of this R&D day, and we'll elaborate on the different options and the strategy forward.
Operator
We will now take our next question from Maury Raycroft of Jefferies.
Maurice Thomas Raycroft - Equity Analyst
Congrats on all the progress. Looking forward to the AFM13 data at ASH, and I'm just wondering if you could talk more about the translational study. And I know that you were taking a series of biopsies from the patients with cutaneous T cell lymphoma. And so can you just talk about the kinetics of changes that you're seeing over time, if that's possible?
Leila Alland - Chief Medical Officer
So I think -- sorry, Adi.
Adi Hoess - CEO, MD & Member of Management Board
Sorry, Leila, I just wanted to hand over to you.
Leila Alland - Chief Medical Officer
Apologies. Yes, so as we said, this is a translational study where all of the patients have cutaneous manifestations of the disease, and the reason for that was so that the investigator could get serial biopsies, pretreatments, and then at multiple time points on study. And the intent was to then look over time what were the changes with respect to NK cells, both total numbers of NK cells and the CD69-positive activated NK cells as well as other immune cells within the tumors. So those data are actually actively being analyzed, and you'll see a thorough presentation at ASH.
Maurice Thomas Raycroft - Equity Analyst
Got it. Can you talk about potential positioning with that program? And whether it would be with the cutaneous T cell lymphoma or a different lymphoma?
Leila Alland - Chief Medical Officer
Well, what I can say is that we recently met with FDA to discuss the AFM13 data to date, including the data from the T-cell lymphoma study. And we discussed proposed designs for future registrational studies. It was a productive meeting and we got valuable feedback from the FDA, and we'll provide details on the path forward on the December 7 meeting, the Investor Event.
Maurice Thomas Raycroft - Equity Analyst
Got it. And for the combo study, just wondering if -- how much additional follow-up we'll see at ASH?
Leila Alland - Chief Medical Officer
So as we said, we'll see data on all 30 patients. So what we'll see their overall response data, the complete response data as well as some preliminary data on progression-free survival.
Maurice Thomas Raycroft - Equity Analyst
Okay. Will it be a more mature cut versus what's in the abstract, as far as follow-up and variation?
Leila Alland - Chief Medical Officer
Yes. We usually plan to -- we plan to provide an update at ASH beyond what was in the abstract.
Maurice Thomas Raycroft - Equity Analyst
Got it. Okay. And then last question is on the NK adoptive cell therapy program with MD Anderson. Just if you can maybe provide perspective on next steps with that and just even general thoughts on interest in NK cell biology. There have been a few different updates in the NK cell space and it seems to be more interest coming to NK cells in immuno-oncology. So maybe just talk a little bit about that program and just the general perspective in the space.
Leila Alland - Chief Medical Officer
Is that for me? Adi, would you like me to take that?
Adi Hoess - CEO, MD & Member of Management Board
Yes, exactly. So I just want to say a few general words before I hand over specifically to you, Leila.
So the idea that we have been pursuing for a while and the rationale we have seen that there is a correlation on number of NK cells available to the absolute efficacy. So that has been investigated in vitro. It has now been investigated in vivo. So we have a very strong rationale that there is the hope that we can deepen and broaden responses due to the addition of NK cells.
Now this cord blood-derived platform from MD Anderson gives us the option not only to provide more NK cells, but it is also a specific way how these NK cells are prepared, so that they are more potent and better activated. So there is an additional effect that's coming in not only from the redirection but that may deliver more potent or more active NK cells than the patient is available to provide.
So this is the general approach behind that, that's why we have been conducting these experiments in the past years. And I'll hand over now to Leila to let you know some more about the specifics where we want to take that.
Leila Alland - Chief Medical Officer
Yes, well, clearly, it's a very exciting and innovative approach and offers the potential for even greater efficacy over what could be achieved with AFM13 as monotherapy. And so with these preclinical data that you'll see in full at ASH, we're in active discussions around next steps to move this approach into the clinic.
Adi Hoess - CEO, MD & Member of Management Board
Let me just make one more -- yes, Maury, let me just make the -- let me make one more comment why our approach is very distinguished and is very unique.
You may recall that we are targeting CD16A in a very different manner than you can do that with as compared with monoclonal antibodies. So our approach has a much higher affinity to CD16A as any of the other options, and thereby, we get a very tight binding to natural killer cells. So this premixing of our NK cell engagers with a prepared NK cell leads to a very strong binding of our NK cell engagers. So we are showing you the details on where the advantages are and how we can, for example, either develop a premixed formulation or we can also think of providing these drugs in coadministration.
So this is very unique for Affimed, having such a CD16A platform.
Operator
We will now take our next question from Jim Birchenough of Wells Fargo.
James William Birchenough - MD and Senior Biotechnology Analyst
Congrats on all the progress. A few questions. Adi, maybe to start with. With the validation from the Genentech deal for your ROCK platform, do you expect to do additional deals? And do you have any metrics in terms of productivity on that side of the business?
Adi Hoess - CEO, MD & Member of Management Board
So yes, thanks for the question. As we've said, this is a landmark deal for Affimed and definitely has created a broad interest in the work that Affimed's been doing. And just to recall, this deal comprises, on the one side, the ability to generate these bispecific antibodies based on the ROCK platform, incorporating our proprietary CD16A engagement technology, plus it also provides that we have developed a deeper understanding of how we can activate innate immune cells.
Obviously, there are many more targets out there that we can pursue -- Affimed can pursue on our own. And as such, we have AFM13 and AFM24, yet unencumbered in our own pipeline, and a few earlier-stage molecules. What we are currently considering is how to optimally move these molecules forward, and that gives us different kind of business model options that we can pursue, and that's what we currently are in discussions with.
So the type of deal that we may envisage may be on the one side similar that we are approaching on a certain number of targets with a potential partner, but Affimed is definitely looking for more upside drives so that we can either think of codevelopment or comarketing.
James William Birchenough - MD and Senior Biotechnology Analyst
And then maybe just for Leila on the C30-positive (sic) [CD30-positive] lymphoma. Could you size that opportunity? Give a sense of how many patients in the U.S. or Europe have CD30-positive disease? And just looking at the data that we're expecting at ASH, how should we think about durability response? And maybe set some expectations on what would be a reasonable durability response as we look at that data.
Leila Alland - Chief Medical Officer
Yes, thank you for that question. So we have analyzed the market sizes for AFM13 in Hodgkin lymphoma and T-cell lymphoma. Although we've not communicated any detail on our expectations, we estimate that it would be in a range similar to that of brentuximab vedotin, the standard therapy for Hodgkin's lymphoma.
Regarding the durability of response, that is, of course, an important parameter, and you'll see the data on durability of response at the presentation at ASH. And I can say that we are encouraged by the durability data that we're seeing.
James William Birchenough - MD and Senior Biotechnology Analyst
And then maybe just a final question on this new opportunity around ALL NK cells and CD16A-directed therapy from Affimed. Does that have the potential to extend the durability of NK cell effects? It seems like CAR-NKs and NK cell therapeutics have pretty short-term effects. Do you expect that this could extend the durability of effect?
And then the second part is just, do you envision moving quickly across different targets like BCMA, EGFR, CD19? How quickly can you move in different directions with that approach?
Leila Alland - Chief Medical Officer
I would say that the potential is great to both increase the proportion of patients who are responding to AFM13 therapy as well as to increase the durability of the response. And so while we're encouraged by the data that we'll be presenting for AFM13 as monotherapy, it's always good to be thinking early about combinations, and this one is certainly a rational combination with great potential, and certainly, could be applied to any other NK cell engager to boost the activity of the engager. So yes, it has certainly re-applicability for future NK cell programs.
Adi Hoess - CEO, MD & Member of Management Board
One particular advantage that we're seeing, Jim -- yes, thanks. Jim, one particular advantage that the strategy has of where we have our engagers in combination with adoptive NK cell transfer was -- is offered by -- and different to a CAR-NK. So the CAR-NK is a single molecule, and once ingested and eliminated, it's gone.
What we can do is we can inject the NK cell platform and the antibodies in a separate fashion and still continue dosing with the antibodies. That's very convenient in order to do. So there are different options and optionalities that are with the Affimed approach, and that's what we can see as a particular advantage of them extending the response rates, and thereby getting better durability through a continuous dosing of -- with our engagers.
Operator
We will now take our next question from Do Kim of BMO Capital Markets.
Neil Puri - Associate
This is Neil Puri. I'm filling in for Do. I had a follow-up question on the cord blood-derived natural killer cells program. Could you guys give a little bit more details as far as how you're thinking about the development strategy, obviously, clinical trials? And then, is this a program you anticipate developing on your own? Or do you have thoughts about partnering with other companies that maybe have existing platforms?
Adi Hoess - CEO, MD & Member of Management Board
Leila, are you going first, please?
Leila Alland - Chief Medical Officer
Yes, sure, sure. So what I can say is that we're having active and frequent discussions with our partners at MD Anderson around a potential clinical trial design. And I think this would be something that we would be ready to share at the Investor Day on December 7. As Adi said, the potential is to give both the combination product but also to be able to continue to dose with AFM13 to augment the effect and the durability of response, and so that's something that we're very excited about taking forward.
Operator
We will now take our next question from Yale Jen of Laidlaw & Company.
Yale Jen - MD of Healthcare Research & Senior Biotechnology Analyst
Congrats on the progress so far. Just last things have been answered and there's only a few here, but first thing is how the AFM11 clinical hold. I recall that the BLINCYTO, when it was in early development also had some serious side effects that need to be readjusted. Do you see any similarity or some similarity to those programs? Or that's very different of the AFM11 versus the BLINCYTO in early stage?
Leila Alland - Chief Medical Officer
Yes, thank you for that excellent question. And I think that is one of the key questions that we're addressing with the clinical investigators and other experts. The toxicities that we've seen, that we've just talked about, are narrow toxicities that are similar to what might be expected when compared to other agents of this class. And so that is something that we're looking at very closely.
Yale Jen - MD of Healthcare Research & Senior Biotechnology Analyst
Okay. Great. That's useful. And also I noticed that on the Slide #6 where you list all the programs, including AFM26, which you, in the presentation say, partnered. Is there any more colors on that specific statement?
Adi Hoess - CEO, MD & Member of Management Board
No. So indeed, it's -- we've disclosed all the details around that and we cannot go into any details of whom we've partnered with nor which targets we're actively pursuing at that stage.
Yale Jen - MD of Healthcare Research & Senior Biotechnology Analyst
Okay. No problem. And maybe the last question here is for the collaboration with the Columbia University. And you mentioned that you have discussions with the FDA for potential registration study. Does that mean that the program could progress into registration maybe as a next step? Or there will be more studies in between before reaching the registration study?
Leila Alland - Chief Medical Officer
Yes, so what I can say is that we met with the FDA to discuss the AFM13 data to date, which included the data from the Columbia study. And what we discussed with them was potential study designs for registrational studies. And this is something that we'll provide details on at the December 7 Investor Event.
Yale Jen - MD of Healthcare Research & Senior Biotechnology Analyst
Okay. And maybe just to tag on that a little bit, which is, is the Columbia study practically completed? In other words, there's no more patient to be added? Or it will still continue? What's the status at this point?
Leila Alland - Chief Medical Officer
So the status is that we completed enrollments for the initially intended population of 9 patients, and we are looking at continuing that study to enroll additional patients.
Operator
(Operator Instructions) We will now take our next question from Jim Birchenough of Wells Fargo.
James William Birchenough - MD and Senior Biotechnology Analyst
I guess wanted just to follow up on questions on AFM11 in the clinical hold. It may be difficult to say but just wondering, can you say if the rotation factors that might have contributed to toxicity at the highest dose? And the second part is, if that dose isn't viable, do you think this next-highest dose is an active dose or competitive and a potential go-forward dose?
Leila Alland - Chief Medical Officer
Yes, thanks, Jim, for that, and those are the key questions that we are seeking to answer in discussions with our investigators and the health authorities. And so it's important to note that in a Phase I study, these patients are all heavily pretreated and have relapsed or refractory disease, so the prognosis is often very poor for these patients. And so looking at, specifically, what it is about the patients that might predict toxicity is a key part of that investigation.
Operator
Thank you. It appears there are no further questions at this time. I'd now like to turn the conference back over to Adi Hoess for any additional or closing remarks.
Adi Hoess - CEO, MD & Member of Management Board
Yes. Thanks once more and thanks again for joining the call today and for this very active discussion, and we very much appreciate this continued interest in our progress.
As I've mentioned before, we're very excited about having entered the collaboration with Genentech, for us a landmark collaboration. But we also believe it can be a door opener to further collaborations also to a -- leading to a certain appreciation of our own programs in the field of CD16A NK cell engagers.
We look forward to an exciting ASH where we're presenting 6 posters and look forward to meeting many of the investors and analysts that were with us on the call today. And lastly, I'm going to remind you that there is an Analyst Investor Day planned on December 7 where we're outlining the future development strategy of AFM13.
With that, I'm closing this call today, and wish you all a very nice day today. Thank you.
Operator
This concludes today's conference call. Thank you for your participation. You may now disconnect.