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EARNINGS CALL TRANSCRIPT
EARNINGS CALL TRANSCRIPT 2018 - Q3
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Executives

Adi Hoess - CEO Florian Fischer - CFO Leila Alland - CMO Greg Gin - Head of IR.

Analysts

Peter Lawson - SunTrust Robinson Humphrey Maury Raycroft - Jefferies Jim Birchenough - Wells Fargo Yale Jen - Laidlaw & Company.

Operator

Good day, and welcome to Affimed’s Third Quarter 2018 Financial Results and Corporate Update Conference Call. At this time, all participants are in a listen-only mode. 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..

Greg Gin

Thank you, operator. Thank you for joining us today for Affimed conference call to discuss the company’s third quarter 2018 financial results and operational progress as well as the important new data containing some of our ASH 2019 abstracts. This morning, Affimed issued a press release, which is posted on the company’s Web site 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 review the data on our programs at ASH. And then Florian will review the financials.

Following the prepared remarks, we will host a 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 titled, Cautionary Statement Regarding Forward-Looking Statements in our Form 6-K filed with the SEC earlier today.

With that, I will now turn the call over to Adi..

Adi Hoess

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 target 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 data 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 non-dilutive financing proximate [ph] supporting further development of our own pipeline and extending our cash run rate beyond the previously guided fourth quarter 2019.

We plan to update our guidance on cash run after we finalize the development path forward for AFM13 including the designs of a registrational clinical study and have more detailed information regarding the timing of future clinical activity. 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 that, such NK engagers are 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 state of our programs.

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 dose levels up to 75 mg/kg over four weeks with no observed toxicities even at high dose levels.

AFM24 is designed to treat patients with a variety of EGFR expressing solid tumors with the potential for better efficacy and safety as compared to other therapeutic 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 gear 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 six presentations highlighting our innate immunity and T cell-based therapeutic programs.

Together with our collaboration partners, we’re looking forward to sharing updated clinical data of AFM13 showing continued promising signs of therapeutic efficacy both in combination with Keytruda in Hodgkin lymphoma and as monotherapy in CD30-positive lymphoma.

I’d also like to point out three preclinical abstracts, one of which we’ll touch on briefly today related to our relationship with the MD Anderson Cancer Center and our 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 rationale combinations with our engagers to investigate potential of achieving more potent and durable anti-tumor 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 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 AFM13, including a potential path forward for accelerated approval. Based on feedback from the FDA, we’re finalizing our plans for a registrational study for AFM13.

We will review the clinical development strategy for AFM13 at an Investor and Analyst event planned for December 7th 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

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 1b study in Hodgkin lymphoma is evaluating the patients’ tolerability of AFM13 in combination with Keytruda or pembrolizumab as a salvage therapy after failure of standard therapies including brentuximab vedotin in relapsed or refractory patients.

The investigator-sponsored Phase 1b/2a 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 microenvironment. Now as you’re 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 six 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 and relapsed/refractory CD30-positive lymphoma with cutaneous lesions show a 50% objective response rate in three dosed cohorts and equal by eight patients including one complete response, 13%, and three partial responses, 38%. Importantly, these data reinforce the potential single agent activity of AFM13.

Our [indiscernible] 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 cell and decreased circulating Tregs compared to non-respondents.

As shown on Slide 8, at ASH, MD Anderson Cancer Center and 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+ 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 1 dose escalation study in patients with relapsed/refractory acute lymphocytic leukemia or ALL.

The data in the ASH abstract released on November 1, 2018 showed two 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 three 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 have completed our evaluation.

We expect the results in the ASH abstracts that I’ve discussed today to be updated with additional follow-up data that will be included in the respected presentations at ASH. Now, I will hand it over to Florian to review the financials.

Florian?.

Florian Fischer

Thank you, Leila. Affimed’s consolidated financial statements have been prepared in accordance with IFRS as issued by the International Accounting Standards Board, or IASB and are 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 in 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 37.1 million as of September 30, 2018 compared to 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 of $96 million or €82.9 million from Genentech. Including the payment from Genentech, pro forma cash and cash equivalents would have totaled €120 million or $138.9 million as of September 30, 2018.

Net cash used in operating activities was 24.9 million for the nine months ended September 30, 2018 compared to 20.7 million for the nine 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 activities. Revenue for the third quarter of 2018 was 300,000 compared to 500,000 for the third quarter of 2017.

Revenue in both periods was solely derived from AbCheck services. R&D expenses for the third quarter of 2018 were 9.8 million compared to 6 million for the third quarter of 2017. The increase was primarily related to higher expenses for early stage development and discovery activities.

G&A expenses for the third quarter of 2018 were 2.4 million compared to 1.9 million for the third quarter of 2017. Net loss for the third quarter of 2018 was 12 million, or €0.19 per common share, compared to a net loss of 8.1 million, or €0.18 per common share, for the third quarter of 2017.

Now, I’ll turn the call back over to Adi for concluding remarks.

Adi?.

Adi Hoess

Thanks, Florian. Thanks again everyone for joining us today. We appreciate you following our continuous program. It is a very exciting time at Affimed with the recent Genentech collaboration, the coming data updates at ASH including six accepted abstracts and as we finalize the future development plans for AFM13 including our registrational study.

Lastly, as shown on Slide 11, we hope you’ll join us on Friday, December 7th in New York City where we host an Investor and Analyst meeting to provide more detail and context on the future clinical and development plan and strategy for AFM13. That completes the formal part of our call. We’ll now open the call to take some questions.

Operator?.

Operator

Thank you. [Operator Instructions]. We will now take our first question from Peter Lawson of SunTrust. Please go ahead, sir..

Peter Lawson

Thanks for taking the questions. Thanks for the update, Adi.

Just on AFM11, when can we see an update? What are the next steps you can start, et cetera? And then is there any color you can provide around the three patients who had issues and just a path forward whether you can change the trial easily or restrict the particular patient groups? Thank you..

Adi Hoess

Thanks, Peter. I’ll hand that question over to Leila..

Leila Alland

Thanks, Peter. So what I can say is that 33 patients have been treated in total in the two Phase 1 studies with preliminary signs of clinical activity observed in patients on the ALL trial. The serious adverse events that were reported in the three patients included a death in the ALL study and two 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 treatment, and hence were considered drug related.

Unfortunately, one patient did not recover and died. The other two 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 Lawson

Do you think that’s a couple of month process or any timelines around that would be great?.

Leila Alland

What I can say is that we’re looking at quickly as possible to thoroughly access the events and to get feedback from investigators and other experts as well as some health authorities. I can’t give you a precise timeline but I can tell you that we’re working on it with our highest priority..

Peter Lawson

Got it. Thank you. And then, Adi, just the Analyst Day, is that – so we should get the registrational plan for AFM13.

Would 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

So we’ve 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 at 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..

Peter Lawson

Great. Thank you so much. I’ll get back into the queue..

Operator

We will now take our next question from Maury Raycroft of Jefferies. Please go ahead..

Maury Raycroft

Hi. Good morning and congrats on all the progress. Looking forward to the AFM13 data at ASH. And I’m just wondering if you can 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 that’s possible?.

Leila Alland

So this is – sorry.

Adi Hoess

Sorry, Leila, I just wanted to hand over to you..

Leila Alland

Yes. So as we’ve 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 pretreatment and then at multiple time points on study.

And the intent was to then look over time at what were the changes with respect to NK cell, 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..

Maury Raycroft

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

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’ve discussed proposed designs for each of 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 7th meeting, the Investor event..

Maury Raycroft

Got it.

And for the combo study, just wondering how much additional follow up we’ll see at ASH?.

Leila Alland

So, as we said we’ll see data on all 30 patients. So we’ll see their overall response data, the complete response data as well as some preliminary data on progression-free survival..

Maury Raycroft

Okay.

Will it be a more mature cut versus what it’s in the abstract as far as follow up and duration goes?.

Leila Alland

Yes. We plan to provide an update at ASH beyond what was in the abstract..

Maury Raycroft

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..

Leila Alland

Is that for me, Adi? Would you like to take that?.

Adi Hoess

Yes, exactly. So I just want to say a few general remarks before I hand over specifically to you, Leila. So I hear that we have been pursuing for a while in the directional, we have seen that there is a correlation on a number of – in case of 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 channel [ph] 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 of our specifics where we want to take that..

Leila Alland

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 at ASH, we’re in active discussions around next steps to move this approach into the clinic..

Maury Raycroft

Great. Okay. Congrats again and thanks for taking my questions..

Adi Hoess

Maury, let me make one more comment why our approach is very distinguished and it’s very unique. You may recall that we are targeting CD16A in a very different manner than you can do that compared with monoclonal antibodies.

So our approach has a much higher affinity to CD16A as any of the other option and thereby we get a very tight binding to natural killer cells. So this premixing of our NK cell engagers with an adoptive prepared NK cell leads to a very strong binding of our NK cell engagers.

We are showing you the details on where the advantages are and how you can for example either develop a premix formulation or we can also think of providing this drug in co-administration. So this is very unique for us in that having such a CD16A platform. Thank you..

Maury Raycroft

Got it. Thank you very much..

Operator

Thank you. We will now take our next question from Jim Birchenough of Wells Fargo. Please go ahead, sir..

Jim Birchenough

Hi, guys. Thanks for taking the questions and congrats on all the progress. A few questions.

Adi, maybe to start 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

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 has 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 engager 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’re 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 maybe 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 so that we can either think of co-development or co-marketing..

Jim Birchenough

And then maybe just for Leila on the CD30-positive lymphoma, could you size that opportunity, give a sense on 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

Thank you for that question. So we have analyzed [indiscernible] AFM13 in Hodgkin lymphoma and T cell lymphoma. Although we’ve not communicated any details on our expectations, we estimate that it would be in a range similar to that of the brentuximab vedotin standard therapy for Hodgkin 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..

Jim Birchenough

Okay. And then maybe just a final question on this new opportunity around NK cells and CD16 directed therapy from Affimed. Does that have the potential to extend the durability of NK cell effects? It seems like CAR NK and NK cell therapeutics are 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

I would say that the potential is great. Those increased the proportionate patients who were 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 rationale combination with great potential. And certainly could be applied to any other NK cell engager to boost the activity of the engager.

But yes, it has certainly applicability for future NK cells..

Adi Hoess

Jim, one particular advantage that the strategy has of where we have our engagers in combination with adoptive NK cell transfer, what is offered by and different to occur [indiscernible] is a single molecule and once injected 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 optionality that are with the ultimate approach and that’s what we can see as a particular advantage of then extending a response rate and thereby getting better durability through a continued dosing with our engagers..

Jim Birchenough

Great. Thanks, Adi..

Operator

We will now take our next question from Do Kim of BMO Capital Markets. Please go ahead..

Unidentified Analyst

How are you doing? This is Neil Peary [ph] filling in for Do. I had a follow-up question on the cord-blood derived natural killer 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 exciting platforms?.

Adi Hoess

Leila, are you going first please?.

Leila Alland

Yes, 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 that would be something that we would be ready to share at the Investor Day on December 7th.

As Adi said, the potential is to give both the combination product but also to be able to continue to go through the AFM13 to augment the effect and the durability of response. And so that’s something that we’re very excited about taking forward..

Unidentified Analyst

Great. Thank you..

Operator

We will now take our next question from Yale Jen of Laidlaw & Company. Please go ahead..

Yale Jen

Good morning and thanks for taking the questions and congrats on the progress so far. Just last things at the end there and just only a few here. The first thing is about the AFM11 clinical hold. I recall that Blincyto when it was in early development also had some serious side effects that needed to be readjusted.

Do you see any similarity or some similarity to those programs or that’s very different of the AFM11 versus Blincyto in early stage?.

Leila Alland

Yes, thank you for that excellent question. And I think that is one of the key questions that we are addressing with the clinical investigators and other experts. The toxicities that we’ve seen – that we’ve just talked about are neurotoxicities 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

Okay, great. Thanks. That’s useful. And I also know that on Slide 6 where you list out the programs including AFM26 which you in the presentation say partnered.

Any more color on that specific statement?.

Adi Hoess

No. So indeed it’s – we have disclosed, all the details are on 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

Okay, no problem. And maybe a last question here is for the collaboration with Columbia University and you mentioned that you have discussions with FDA for a potential registration study.

Does that mean that the program could progress into registration maybe as the next step or there will be more short studies in between before reaching the registration study?.

Leila Alland

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’ve discussed with them was potential study designs for a registrational study. And this is something that we’ll provide details on at the December 7th Investor event..

Yale Jen

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 patients to be added or it will still continue? What’s the status at this point?.

Leila Alland

So the status is that we completed enrollment for the initially intended population of nine patients and we are looking at continuing that study to enroll additional patients..

Yale Jen

Okay, great. Thanks a lot. Again, congrats on the progress..

Operator

[Operator Instructions]. We will now take our next question from Jim Birchenough of Wells Fargo. Please go ahead, sir. Again, please go ahead, sir. Your line is now open..

Jim Birchenough

Sorry, I was on mute. I did want to just follow up on questions on AFM11 and the clinical hold. It may be difficult to say but just wondering can you save 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 the next highest dose is an active dose or competitive and a potential go-forward dose? Thanks..

Leila Alland

Yes, thanks Jim for that. And those are the key questions that we’re seeking to answer in discussions with our investigators and the health authorities. And so it’s important to note that in a Phase 1 study, these patients are all heavily pretreated and have relapsed or refractory disease, so the prognoses is often very poor for these patients.

And so looking at specifically what it is about the patients that might predict toxicity is the key part of that investigation. Thank you..

Jim Birchenough

Great. Thanks for taking the follow up..

Operator

Thank you. It appears there are no further questions at this time. I would now like to turn the conference back over to Adi Hoess for any additional or closing remarks..

Adi Hoess

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 have mentioned before, we’re very excited about having entered the collaboration with Genentech.

It was a landmark collaboration, but we also believe it can be a door opener to further collaborations and also to leading to certain appreciation of our own programs in the field of CD16A in NK engagers.

We look forward to an exciting ASH where we are presenting six posters and I look forward to meeting many of the investors and analysts that who are with us on the call today. And lastly, I’m going to remind you that there is an Analyst and Investor Day planned on December 7th where we are outlining the future development strategy of AFM13.

With that, I am 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..

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