Affimed NV (AFMD) 2020 Q3 法說會逐字稿

Good day, everyone, and thank you for standing by, and welcome to Affimed's Third Quarter 2020 Financial Results and Corporate Update Conference Call. As a reminder, today's conference call is being recorded.

I would now like to introduce to -- your host for today's conference call, sir Alex Fudukidis, Head of Investor Relations at Affimed. Please go ahead.

Thank you, operator. I'd like to welcome and thank you all for joining us today for Affimed's Third Quarter 2020 Financial Results and Operating -- Operational Update Call.

Before we begin, I'd like to remind everyone that the press release issued earlier today related to our earnings call can be found on the Investor Relations section of our website. We have also posted update slides -- updated slides that will be used to guide our discussion today.

On the call today, we have Dr. Adi Hoess, our Chief Executive Officer; Andreas Harstrick, our Chief Medical Officer; Arndt Schottelius, our Chief Scientific Officer; Dr. Wolfgang Fischer, our Chief Operating Officer; Ms. Denise Mueller, Chief Business Officer; and Angus Smith, our Chief Financial Officer. The whole team will be available for the Q&A session.

Before we start, I will quickly go through the 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 call. 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 these 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 Forward-Looking Statements in the press release that we issued today and filed with the SEC.

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

Thank you, Alex, and good morning, everyone, and thanks for joining us for our third quarter 2020 business update call.

If you saw from our press releases today and yesterday, we have a number of quite exciting updates to report on, including progress on our clinical programs, acceptance of key data at major conferences and importantly, we have forged new strategic partnerships which will help expand the opportunities for the ROCK platform and thereby give patients who need more therapeutic options.

Our ROCK platform is the foundation for future value creation at Affimed for its ability to generate a set of diverse innate cell engagers for a multitude of hem and solid tumor cancers with consistent profiles to license and safety. The platform uniquely activates all variants of CD16A with unprecedented affinity, and its engagers can be customized to specific tumor targets guaranteeing a sustainable pipeline of novel and potentially curative medicines. That platform has a proven record of brevity and predictability predictably building potent and stable CD16A targeted innate cell engager molecules tailored to specific diseases. We believe this platform positions us as a leader in the field of innate immunity.

Our goal is to leverage this platform to broaden the opportunities within our pipeline to create value and ensure our transformative medicines to reach patients in need. To achieve this goal, we have a three-pronged strategic approach. First, we're driving the development of our innate cell engager molecules, such as the -- in monotherapies in areas of high unmet need. Second, we're pursuing novel therapeutic combinations, including the combination with NK cell therapies and other I-O to I-O approaches, such as checkpoint inhibition. The third component of our strategy is thoughtful partnering to expand deep myeloid scientific expertise and provide options to accelerate our pipeline while bringing in nondilutive cash. And we're very excited today to report that we have made substantial progress on all 3 components of our strategy. We have made important clinical progress on our monotherapy approaches for -- of our wholly owned molecules, AFM13 and AFM24, and Andreas will provide more details on this shortly.

We further advanced our strategy of exploring novel combinations for our molecules, particularly combinations with NK cell therapy. And yesterday, we announced an agreement with Roivant Sciences to expand and diversify our strategic collaboration. The Roivant collaboration is a further validation that our innate cell engagers can play an important role in the fight against cancer. This collaboration will accelerate the development of AFM32, provide significant nondilutive capital for the company and thereby extending our cash run rate. Denise, Wolfgang and Arndt will address these collaborations and the rationale behind them in their remarks.

However, before we discuss the new collaboration, let me hand over the call to Andreas, who provides you an update on our clinical progress. Andreas?

Thank you, Adi, for the overview, and welcome from my side to everybody who joined us on the call today. We are very pleased that today, we could report that we are making good progress on both of our wholly owned clinical stage molecules, AFM13 and AFM24.

Let's start with AFM13, our first-in-class innate cell engager for patients with CD30-positive lymphomas. Here, we are very pleased to report that AFM13-202 has continued to recruit well and has now reached the required number of patients, both in the high CD30 expressing as well as in the low CD30-expressing cohorts that are prespecified and required for the preplanned interim analysis. We are expecting to complete the interim analysis in the first half of 2021.

As you may recall, AFM13-202 is a registration-directed monotherapy study investigating AFM13 in patients with relapsed and treatment-refractory peripheral T cell lymphomas. If we stay with AFM13, we also reported that the first patient in study AFM13-104 has completed the first 4-week cycle of therapy and has achieved a partial response according to local investigator assessment. This patient is scheduled to receive a second cycle of treatment, and we are also looking forward to enroll the second patient at the same dose level. As a reminder, AFM13-104 is an investigator-sponsored Phase I study conducted at MD Anderson Cancer Center, which is evaluating the tolerability and efficacy of AFM13 preloaded allogeneic cord blood-derived natural killer cells, followed by weekly AFM13 infusions in patients with refractory CD30-expressing lymphomas. In the dose escalation part of the study, the dose of NK cells is increased from 10 to the 6th NK cells per kilogram body weight to 10 to the 7th and finally, to 10 to the 8th NK cells per kilogram. The study can further expand and include more patients at the recommended dose.

Turning to AFM24, our innate cell engager for EGFR-expressing malignancies. We announced this morning that we have cleared cohort 2 and are treating patients in cohort 3 in the dose escalation part of this Phase I/Phase IIa clinical study. Patients that are enrolled in this study are patients having relapsed/refractory advanced EGFR-expressing solid tumors. The aim of the dose escalation phase, as you know, is to determine the maximum tolerated dose and to establish a recommended dose for further Phase II testing. The Phase IIa dose expansion phase is intended to collect preliminary evidence of activity of AFM24 as a single agent and to further confirm the safety and side effect profile. For the expansion study, we have identified a number of indications where we believe that monotherapy treatment for AFM24 is suitable.

We are pleased with the progress being made in the AFM24 dose escalation study and are optimistic about the potential of AFM24 as a safe and effective monotherapy for certain patients with EGFR-expressing solid tumors. We also recognize that treatment strategized in immuno-oncology often rely on finding combination approaches for certain patient populations and/or indications. With this in mind, we are actively looking towards preparing clinical combinations of AFM24 with checkpoint inhibitors like PD-1 or PD-L1 antagonists as well as combinations with both allogeneic and autologous NK cells. We believe that this broad strategy will increase and expand the clinical utility of AFM24 with the goal to provide better patient outcomes. Wolfgang and Arndt will go into more detail about the rationale and the approach behind the combinations of our innate cell engagers with NK cell therapies in their remarks.

Before we turn to that, Denise will present more details about the deals and the collaborations that we have announced over the last few days. So may I hand over to Denise, please.

Thanks, Andreas. Good morning, everyone. A real pleasure to be here today to give you an update on our recent business development activity.

I'll start today with some details around the Roivant transaction. Roivant collaboration diversifies our partnership with industry innovators and will help accelerate the development of AFM32 as well as our own pipeline while providing significant value not only to our shareholders, but our patients. The highlights of the agreement include granting Roivant a worldwide license to our preclinical asset, AFM32, as well as options to develop other novel targets that currently are not within our pipeline. We will receive $60 million in upfront consideration, which consists of $40 million in cash and prepaid R&D and $20 million of Roivant stock.

Additional financial terms include up to $2 billion in future milestones with potential near-term milestones tied to options to develop novel molecules beyond AFM32. Affimed is eligible to receive tiered royalties of net sales on all the molecules developed under this agreement. Our responsibility in the collaboration is to drive discovery, research, all IND-enabling preclinical development, which is funded completely by Roivant. Roivant will be responsible for clinical development and commercialization worldwide. But what's important here for Affimed is that we retain the option for co-promotion. The Roivant business model and the structure of the terms, which include upside potential in terms of Roivant stock, the cash upfront and the full funding of R&D work as well as the opt-in to co-promote, make Roivant an ideal partner to drive and enhance value to our shareholders.

Now we also recently announced 2 other partnerships, which are designed to support, enable the combination strategy that Adi alluded to. As a leader in innate immunity, we very much recognize the emerging and expanding role that NK cell therapy can play in comprehensive innate immunity therapeutic approaches. As a result of this, we've done a tremendous amount of work analyzing a number of NK cell technologies for combination approaches to enhance therapeutic benefit. We believe our innate cell engagers can offer substantial value to NK cell products and have taken a careful, thoughtful approach to selecting the right NK cell partners that not only have leading technology, but are also aligned with our strategic mindset. We entered into collaborations with companies that are developing different types of NK cell platforms to enhance our flexibility, each of which has a different focus. And together with MD Anderson, this allows us to broadly explore combination options for innate cell engagers and generate data in a variety of clinical and preclinical scenarios. We believe these partnerships position us well to lead and define this emerging area within immuno-oncology.

I'll move to a few details, which might be of interest. We announced the collaboration with NKMax. This is a clinical collaboration looking at the co-administration approach of AFM24 with adoptive NK cell transfer. We will be using NKMax's SNK01, autologous NK cell product at first, which is meaning the cells are coming from the patients. And our goal is to transition to a combination with NKMax's allogeneic cell products. We have co-sponsored the IND and clinical development costs will be split 50-50, each of us is responsible for manufacturing and development of the product that we bring to the collaboration.

And last Thursday, we announced the collaboration with Artiva to pursue off-the-shelf combination products, which are co-manufactured by preloading Artiva's clinical-grade allogeneic cells with our innate cell engagers. The combo product has been cryopreserved in a single vial. The products developed under this collaboration represent a novel approach and a new class of drug, which avoids the complex engineering of CAR-NK while still providing that powerful, targeted innate immune system-based therapy.

Our new collaborations, combined with our ongoing work with MD Anderson, allow us to explore these diverse approaches in parallel and to more broadly understand development opportunities for innate cell engagers in combination with NK cell therapies. We look forward to providing you updates in the future on the progress of all of our collaborations.

I will turn things over to Wolfgang and Arndt, who will walk you through the scientific rationale and some of the data that support pursuit of these combinations. We'll start with Wolfgang. Wolfgang?

Thank you, Denise. Welcome to everybody on the call also from my side.

As you have heard from the team, a key component of our strategy is to broaden the applicability of our innate cell engagers by pursuing combinations. We thought it would be helpful to spend a few minutes discussing the scientific rationale for the therapeutic approach of combining our innate cell engagers with NK cell.

Several lines of evidence have demonstrated the potential of NK cells in cancer therapy. First, in previous clinical trials, mainly in AML and MDS patients, treatment with adoptive NK cell transfer has shown objective responses and good tolerability. Second, there is evidence showing that high NK cell numbers are associated with better outcomes. For example, patients with metastatic cutaneous melanoma have improved survival rates if their tumors show evidence of NK cell infiltration. Third, in a more recent trial, adoptive NK cell transfer was combined with rituximab in patients with hematological tumors reaching high ORRs. Fourth, the first data with CD19 current K cell showed encouraging high ORR rates with a much better safety profile known from CAR-T approaches.

In summary, we believe NK cell therapy can play an important role in comprehensive innate immunity therapeutic approaches, and we, through 3 distinct collaborations, are establishing Affimed as a leader in the space of innate immune therapy. Combination of our innate cell engager molecules with NK cell therapy could potentially represent powerful clinical strategies for treating cancer patients. Our approach to NK cell combination is strongly supported by preclinical data, evaluating the synergistic potential of NK cells with our innate cell engagers.

Our preclinical work with MD Anderson Cancer Center evaluated cord blood-derived expanded and activated NK cells preloaded with AFM13. These initial investigations showed a clear synergistic effect in vitro and in vivo and are the basis for the AFM13-104 study, which was mentioned by Andreas before. Importantly, in this context is also that we have observed that our innate cell engagers possess strong cell retention binding on NK cells when compared to monoclonal antibodies. The collaboration with NKMax will add to the body of clinical evidence through the co-administration of AFM24 with SNK01 autologous expanded and activated NK cells in patients with EGFR-expressing tumors in a clinical Phase I/II trial without an (inaudible).

In addition, the research collaboration with Artiva Biopharmaceutical is aiming for the development of several off-the-shelf, preloaded allogeneic NK cell product. Both collaborations, as said before, are based on previously conducted preclinical studies demonstrating the synergy of the combination of our engagers with NK cells.

In summary, we believe that the combination of our engagers with NK cells can be differentiated from monoclonal antibody NK cell combination and CAR-NK and will be a key component of our value creation strategy. As you can imagine, we are very happy to be partnered with some of the leading institutes and companies that have developed these high-quality NK cell product platforms.

I will now turn over the call to Arndt, who can provide more details into the data supporting our belief in the power of the innate cell engagers plus NK cell approach. Arndt?

Thank you, Wolfgang, and a very good morning to everyone on the call.

In the next few minutes, I would like to briefly discuss the preclinical data generated through a collaboration with the University of Texas MD Anderson Cancer Center and Washington University School of Medicine, which will be the focus of an oral presentation at the upcoming SITC conference. This collaboration has identified promising combinations of AFM13 with cytokine-activated adult blood or cord blood natural killer cells against CD30-positive hematological malignancies.

The data show that combinations with natural killer cells deepen the in vitro and in vivo efficacy with our AFM13 innate cell engagers and that this effect was particularly strong with cells from healthy donors. The collaborative research analyzed the AFM30-mediated tumor cell killing in combination with several NK cell products, including conventional natural killer cells from healthy donors, NK cells from patients with Hodgkin lymphoma, cytokine-induced memory-like NK cells from peripheral blood and preactivated cord blood natural killer cells. The cord blood-derived NK cells were then stably preloaded with AFM13, enhancing the responses to CD30-positive lymphomas in vitro and in vivo in immunodeficient NSG mouse models. The conventional natural killer cells from healthy donors exhibited superior responses versus those from Hodgkin lymphoma patients when combined with AFM13, suggesting that the source of NK cells impacts tumor cell killing. Cytokine-induced memory-like NK cells exhibited enhanced killing of CD30 lymphoma cells when directed to the tumor by AFM13 compared to conventional NK cells.

These data formed the basis of an investigational New Drug Application and further substantiate the rationale for combining AFM13 with adoptive NK-cell-based therapies, as is being currently investigated in the Phase I clinical study in MD Anderson Cancer Center.

Now let me briefly summarize the features of our innate cell engagers, which are strongly differentiated vis-à-vis normal and Fc-enhanced monoclonal antibodies and CAR-NK cells. Firstly, our innate cell engagers bind to CD16A on NK cells and macrophages with high affinity leading to effective tumor cell killing by our ADCC and ADCP.

As you can see on Slide 14, our innate cell engager-based drug candidates exhibit superior license of primary tumor cells via ADCC in the presence of healthy donor-derived allogeneic NK cells when compared to Fc-enhanced IgG1 targeting the same antigen. Secondly, as you can see on Slide 15 on the left, our innate cell engagers have superior binding and retention of NK cells, which has been shown to persist over several days. In strong contrast, normal IgG and also Fc-enhanced antibodies rapidly fall off the NK cells, as you can see on the figure. Importantly, as you can see on the right of the slide, the addition of physiological levels of polyclonal IgG as found circulating in the human body has no or minimal competing effect on the binding of an innate cell engager to NK cells since its binding epitope on CD16A is distinct from the Fc-binding epitope of an IgG molecule. And finally, as you can see on Slide 16, NK cells preloaded with our high-affinity innate cell engagers show improved tumor cell killing, which is fully maintained after freezing, thawing and washing, as you can see on the right-hand side. This approach rendering NK cells into a CAR-NK in-situ-like molecule without the need for engineering may thus offer superior antitumor efficacy and strong differentiation.

We believe that the broad and diverse approach to generating further evidence of these novel combinations of our innate cell engagers with adoptive NK cell-based therapies will lead to a suite of flexible options for dosing administration and ultimately advanced important therapeutics in the fight against cancer.

I will now turn the call over to Angus to provide an update of our financial position and quarterly results. Angus?

Thank you, Arndt, and nice to be speaking with everyone this morning.

Affimed's consolidated financial statements have been prepared in accordance with IFRS as issued by the International Accounting Standard Board, or IASB. 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 in this call, unless otherwise noted, will be in euros.

We ended the third quarter with cash, cash equivalents and current financial assets of EUR 97.3 million compared to EUR 104.1 million on December 31, 2019. During the quarter, the company received net proceeds of approximately EUR 11.6 million under its at-the-market, or ATM, program and a milestone payment from its partnership with Genentech in an undisclosed amount. The proceeds to be received in the collaboration we announced with Roivant yesterday are not included in our liquidity position as of September 30. As Adi mentioned, we will receive EUR 40 million in upfront cash and prepaid R&D funding up to $2 billion in potential milestones and tiered royalties from this collaboration.

The financial contribution from this agreement provide Affimed with an important source of nondilutive funding. And combined with our Genentech collaboration, we are now eligible to receive a total of up to $7 billion in potential milestone payments that can serve as additional sources of capital for Affimed and create substantial value for our shareholders.

Our pro forma cash position as of September 30, 2020, included the $40 million of -- including the $40 million of upfront cash proceeds from the Roivant collaboration would be EUR 131.5 million. Based on our current operating plan and assumptions, including the proceeds from the Roivant collaboration, we anticipate that our cash, cash equivalents and current financial assets will support operations into the first half of 2023. Net cash used in operating activities for the quarter ended September 30, 2020, was EUR 3.6 million compared to EUR 11.7 million in the third quarter of 2019.

Total revenue for the third quarter of 2020 was EUR 10.5 million compared with EUR 2.1 million in the third quarter of 2019. Revenue in the third quarter of 2020 and 2019 predominantly relates to the Genentech collaboration. Revenue from the Genentech collaboration in the third quarter of 2020 was comprised of revenue recognized for collaborative research services performed during the quarter and the recognition of revenue related to a milestone payment.

R&D expenses for the third quarter of 2020 were EUR 10.1 million compared to EUR 11.7 million in the third quarter of 2019. Expenses in 2020 relate predominantly to our AFM13 and AFM24 clinical programs as well as to our early-stage development and discovery activities. G&A expenses for the third quarter of 2020 were EUR 3.5 million compared to EUR 2.8 million in the third quarter of 2019.

Net loss for the third quarter of 2020 was EUR 6 million or EUR 0.07 per common share. And for the third quarter of 2019, the company's net loss was EUR 10.9 million or EUR 0.17 per common share. The weighted number of common shares outstanding for the quarter ended September 30, 2020, were 86 million. Finally, we encourage shareholders to also review our 6-K filing for the quarter as filed with the SEC this morning.

I will now turn the call back to Adi for closing remarks. Adi?

Thank you very much, Angus.

Now being in the midst of COVID and this pandemic, hearts and minds are rallying behind the quest for a vaccine for COVID-19, particularly watching with vested interest as the heightened level of public-private partnership strives to quickly produce testing options and the solution. This approach is what drives Affimed as we strive to achieve our goals to enhance and add clinically meaningful benefit in the treatment of cancer.

We continue to make progress with our pipeline with our existing collaborations and by establishing new strategic partnerships, such as the ones we recently announced with Roivant, NKMax America and Artiva. Importantly, we now have a strong cash position with funding into at least the first half of 2023. Thanks to the depths and breadths of industry leadership experience helping our company, Affimed is at an inflection point in the trajectory of our company, and we are excited to share more as we progress -- more news as we progress into the next year.

Briefly again, some of the key inflection points until mid-2022 include: for AFM13, we expect to complete the interim analysis of our registration-directed study for pTCL as monotherapy in the first half of 2021 and provide updates on the progression of our combination study with the cord blood-derived NK cell product at MD Anderson Cancer Center. For AFM24, we expect to report safety and activity data from the ongoing Phase I dose escalation study and initiation of multiple expansion cords as monotherapy. We will update you on the initiation of combination studies with NK cells and further IO agents as well provide updates on progression of these studies. Our preclinical asset, AFM28, we expect to report data from preclinical studies and our IND filing. On our collaboration with Roivant, we look forward to the initiation of AFM32 enable -- IND-enabling studies and providing updates on AFM32 and the additional programs.

Before we open the call for Q&A, I would like to say thank you to the patients who entrust us with their health; our colleagues who are doing their very best to advance our company, our science and our programs; and to our investors who believe in us and continue to support our scientific discoveries. Finally, our recent achievements are a testament to the drive, dedication and passion of our employees who are unrelenting in their pursuit to stop cancer from ever derailing patients' lives.

We have the whole team here, and I look forward to your questions. Operator?

(Operator Instructions) Your first question comes from the line of Do Kim from BMO Capital Markets.

Congrats on all the partnerships. My first question is on your NKMax partnership. In your comments about your SITC presentation, you talked about the conventional NK cells from healthy donors being better than from cancer patients. Why do you believe that NKMax's autologous NK cell product will behave differently than your preclinical data?

Wolfgang, can you take this question, please? And Arndt, you can support him.

Yes. This is Wolfgang. The data from NKMax's previous preclinical study, but also they have shown in the clinical study that their SNK cells work very nicely and resulted in response rates and also had even higher response rates when they combined it with PD-1. The presentation at SITC is a presentation from MD Anderson Cancer Center, Katayoun Rezvani; and from -- (inaudible) from WashU. And here, they present the impact, preclinical impact or preclinical studies from AFM13 on these cord blood-derived NK cells and on so-called [cyto] cell memory-like NK cell from (inaudible). And the data have shown also when they use NK cells from Hodgkin lymphoma patients or that has been shown previously, and they incubate these cells with AFM13 that these cells are highly functional again. Does this answer your question?

Yes. Yes. That's very helpful. And my second question is with the numerous partnerships you have now. Can you talk about how you will determine what target goes to each partner in the future and what you plan to keep internally? How do you think about that?

Denise, can you take that question, please?

Sure. Are you specifically relating to Genentech and Roivant and target selection process, just to clarify?

And also in NKMax and...

Okay. Yes. And in Artiva. So I'll address Genentech and Roivant first because those are obviously similar in that we are developing novel molecules for them with a specific target that is selected by the partner. As you may recall, the Genentech partnership, they selected their last target last year. And so it came from them. And in Roivant's case, they obviously selected preclinical asset, AFM32, and then target selection moving forward will be at their discretion provided the target is not already taken by somebody else or part of Affimed's preclinical pipeline.

In terms of NKMax, we've decided to start with AFM24 primarily because the autologous product does not need [cell] modification, and we felt that it was amenable for solid tumors. Moving forward, Affimed will decide in collaboration with NKMax whether to expand the clinical collaboration with our other innate cell engagers based on the data that's generated from the AFM24 clinical collaboration.

In terms of Artiva, we've decided again to start with AFM24, and we will also be pursuing AFM13 in a co-vialed premanufactured products, given that these are both clinical products or clinical assets for Affimed at this time. And then we will consider whether or not we expand into other options based on our preclinical pipeline and based on strategical -- strategic approach of both companies.

Your next question comes from the line of Jim Birchenough from Wells Fargo. There is an interruption on the line. Your next question comes from the line of Daina Graybosch from SVB Leerink.

This is Dilip sitting in for Daina. Just a little bit more on your strategy here. Should we be expecting additional collaborations with NK cell commercial partners? And is the plan to select one for late-stage development after data reads out? And then on the Roivant, can you confirm if the target for AFM32 was brought forward by Roivant or was this internally discovered at Affimed?

Yes. I'll take that question. So regarding the NK cell partnerships, as we've explained, we've been selecting the field and currently came down with the collaboration because they offer us a breadth of opportunities that what we are -- what we want to explore. So we're good for the moment. However, this is a very dynamic field, and we have numerous additional context. And again, there are others that progress. So with the way how we have done it, we keep our -- we can still keep our options open. But on the other side, with each of these parties, we're really developing a product. So it's dependent on the outcome how well all these is progressing, so we can decide based on data on how we move forward. And that was important for us that we can come to a broad set of collaborations that gives us really a build on optionality. So we're indeed very happy with our 3 partnerships.

Regarding the target. So AFM28 and AFM32 have been targets that we selected about a year, 1.5 years ago and have started earlier-stage program. So each of these targets were selected by Affimed based on a particular algorithm. And I'll give you just a few examples. One of the algorithms parameters has been that an antibody already has been in the clinic and has shown clinical data, but not meaningful data and maybe also a antibody drug conjugate has been developed but not providing the optimal therapeutic window. So we picked particular targets where we thought that they have a rationale. And based on this rationale, we could entertain the discussion.

And this is what -- is indeed what brought Roivant in, that we have a very solid rationale for why we choose targets and why we would develop and how we would develop them in particular indications. And this process is ongoing again at Affimed. So we're creating additional options for further targets so we can still broaden the space with our platform quite significantly. And we'll have additional novel agents available either for future own developments. But again, we can strike deals based on the breadth of knowledge the company has in the innate field and based on the rationale of how we would bring forward such companies that's already such target.

Okay. And finally, I may have missed it, but is the dose escalation data from AFM24 still on track to be reported in first half 2021?

Andreas?

Yes. We have said previously, this is a dose escalation study with a very innovative agent. So it's a little bit difficult to predict how many dose levels we will have to test. We have, as we said, cleared dose levels 3 actively recruiting dose level -- we have cleared dose level 2 actively recruiting dose level 3. So this study is progressing as predicted. But again, with a very novel entity, it's a little bit hard to say how many dose cohorts you will have to reach the recommended Phase II dose.

Your next question comes from the line of Jim Birchenough from Wells Fargo.

Can you guys hear me?

Yes. We can hear you well, Jim.

Congrats on all the progress, Adi and team, and the terrific partnerships. So maybe just to start for Arndt. If you could talk a bit about the Artiva platform and what drew you to that NK cell platform specifically? It sounds like you've interrogated a wide range of different NK cell approaches. And so maybe just what you liked about that one. And I guess the second question might be for Andreas, but is there a scenario where study 202 interim provides an opportunity to add an NK cell therapy to the protocol? Is there any possibility of that outcome off of the interim?

Thank you, Jim. So Andreas, why don't you take the second question first and then Arndt and Wolfgang can jump in on the Artiva and the cells?

Yes. So as you know, AFM13-202 is a registration directed study, which was discussed and agreed upon with FDA and regulators. So I think there is not an option and no intention to modify the study. We see this as an opportunity to pursue an accelerated approval process if we can basically repeat the activity level that was shown in earlier studies like the Columbia study. Now as Wolfgang and Arndt have indicated, both of our partnerships with NKMax as well as with Artiva allow us to work with both assets, AFM24 as well as AFM13. So we are definitely looking with our partners into options whether and at which point it may make sense to combine AFM13 with NK cell products, but it's unlikely that it will be a part of the 202 study.

Thank you, Andreas. Arndt?

Yes. I'll start and Wolfgang can chime in. So we looked at NKMax and Artiva closely, very impressed really when we did the preclinical studies in-house, both companies, high and consistent functionality. When we combined with our ICEs, we saw, likewise, very nice synergism, increased cytotoxicity against the specific targets, also increased cytokine secretion, degranulation, we looked at that very carefully. But also when you look at the platforms and manufacturing, I'll let Wolfgang comment here, that was very well in place in both places, including cryopreservation.

And Wolfgang, do you want to comment maybe a little bit also on the GMP process?

Yes. I was on mute, sorry. Looking at it from a CMC perspective, right, we looked at these NK cell products. And Artiva had a very robust and reliable process established in collaboration with the Green Cross in South Korea. So they have really established a process and really analyzed several batches and had a very homogeneous product not only from a phenotype, but also from a functionality, which was very high, as Arndt just mentioned. On top of that, right, their cryopreservation process, and we all know that cryopreservation of NK cells is not an easy task, was -- or is very, very stable and robust as well. So these have been some factors which we looked at and considered the product and the manufacturing as very good.

Your last question comes from the line of I-Eh Jen from Laidlaw & Co.

And also I had my congrats for the other development in the deals consummated lately. My first question, just trying to confirm, in terms of AFM202 study, the pre-specified, the number patients, is that 40 or that's a different number now?

Yes. I can answer these questions. As we said, the 2 cohorts of the CD30 expressing, high expressing, low expressing, are analyzed separately. And these analyzers are based on 20 patients per cohort, so the total data set will be 40 patients.

Okay. Great. And maybe a little bit housekeeping questions. In terms of the Roivant revenue -- I'm sorry, yes, revenue you received, I assume that will be amortized. Could you give us some guidance in terms of how that will be projected?

Yes. This is Angus. I can take that question. I mean we're still obviously working through the accounting having just announced the deal yesterday, but I anticipate that a portion of the revenue will be recognized in the fourth quarter and then there will be a portion of it that will also be amortized.

Okay. Maybe last question here is that how would you reconcile -- it seems that the Artiva efforts -- Artiva expertise is very similar to -- the design and that the approach is very similar to that of MD Anderson. So how would you reconcile these 2 different collaborations going forward in terms of either commercialization or other product development?

Yes. I think that's premature. So as we've said, for us, it's been really important to be broadly active in this field. We realize that we have a differentiating platform with the ROCK platform that allows high affinity binding to CD16A being noncompetitive to circulating IgG. So ensuring that a loaded cell indeed can reach the target without any hurdles and stays on the cell. So this is the situation we have, and we also learned that there is -- there are multiple opportunities for collaborations. And with Artiva, NKMax and MD Anderson, we truly have found platforms that highly synergized and we now want to explore. So at the end, we felt that a breadth of collaboration suits us best. Thank you.

Thank you. We have no further questions at this time. Please go ahead.

Yes. I'm concluding this earnings call, and thank you to all of you for attending today. It's been quite a exciting day and indeed exciting weeks for us being able to strike all these partnerships, move forward with the programs and creating different options. And as we're saying, our strategy around an innate cell engager is truly built on scientific rationale. So we try to develop those in monotherapy settings where we feel that there is a good degree of chance of seeing a meaningful benefit.

We're looking into combinations with NK cells as this may increase the efficacy in particular settings. And the third pillar is the combination with checkpoints. Again, we've already in the past generated data of AFM13 plus PD-1 and we have shown that it can double the CR rate of the PD-1 in monotherapy. So quite exciting times for us, and we look indeed forward to providing data throughout 2021 and 2022. Now with having a runway in 2023, this is quite a solid situation that we have achieved.

Thank you very much and have a nice day.

Thank you. Ladies and gentlemen, that does conclude your conference for today. Thank you for participating. You may now all disconnect. Speakers, please stand by. Thank you.