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Edited Transcript of AFMD earnings conference call or presentation 27-Mar-19 12:30pm GMT

Full Year 2018 Affimed NV Earnings Call

Heidelberg Apr 1, 2019 (Thomson StreetEvents) -- Edited Transcript of Affimed NV earnings conference call or presentation Wednesday, March 27, 2019 at 12:30:00pm GMT

TEXT version of Transcript

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Corporate Participants

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* Adi Hoess

Affimed N.V. - CEO, MD & Member of Management Board

* Florian H. M. Fischer

Affimed N.V. - MD, CFO & Member of Management Board

* Gregory Gin

Affimed N.V. - Head of IR

* Leila Alland

Affimed N.V. - Chief Medical Officer

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Conference Call Participants

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* Daina Michelle Graybosch

SVB Leerink LLC, Research Division - MD & Senior Research Analyst

* Guyn Kim

BMO Capital Markets Equity Research - Analyst

* I-Eh Jen

Laidlaw & Company (UK) Ltd., Research Division - MD of Healthcare Research & Senior Biotechnology Analyst

* Maurice Thomas Raycroft

Jefferies LLC, Research Division - Equity Analyst

* Nicholas M. Abbott

Wells Fargo Securities, LLC, Research Division - Associate Analyst

* Peter Richard Lawson

SunTrust Robinson Humphrey, Inc., Research Division - Director

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Presentation

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Operator [1]

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Good day, and welcome to Affimed's Full Year 2018 Financial Results and Corporate Update Conference Call. (Operator Instructions) As a reminder, today's conference is being recorded. And I will now introduce your host for today's conference, Greg Gin, Head of Investor Relations at Affimed. Please go ahead.

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Gregory Gin, Affimed N.V. - Head of IR [2]

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Thank you, operator. Thank you for joining us today for Affimed's conference call to discuss the company's full year 2018 financial results and operational progress. 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, Chief Executive Officer 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 year. Leila will follow and review the key data from our programs that were presented at the ASH Annual Meeting, and then Florian will review the financial results. Following their 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 entitled Cautionary Statements Regarding Forward-looking Statements in our Form 6-K filed with the SEC earlier today.

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

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Adi Hoess, Affimed N.V. - CEO, MD & Member of Management Board [3]

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Thanks, Greg, and good morning, everyone. Thanks a lot for joining us for this earnings call.

Affimed made substantial progress throughout 2018 as we continued to transition our company from its origin in antibody engineering to an immuno-oncology therapeutics company committed to advancing our CD16A innate cell engagers generated from our fit-for-purpose ROCK platform. In 2018, we achieved tremendous clinical and corporate milestones as we continued to focus on actualizing the untapped potential of the innate immune system to give back patients their innate ability to fight cancer.

Our clinical progress is highlighted by multiple data presentations at the 60th Annual ASH Meeting that supports the substantial opportunity for AFM13 as both monotherapy and combination therapy in CD30-positive tumors. In a few moments, Leila will provide a summary of our key data that were presented at ASH. Leila will also review the U.S. registrational pathway and updated clinical development plan for AFM13 that we announced at our R&D Day in December.

Our corporate progress is highlighted by the strategic collaboration that we entered into with Genentech in August 2018 for NK cell engager-based immunotherapeutics generated from our CD16A-targeting ROCK platform. This partnership is a transformational accomplishment for Affimed and has the potential to accelerate the understanding of the role of innate immune cell engagement and activation within immuno-oncology. We plan to leverage the respective strengths of Affimed and Genentech to advance the development of CD16A-targeting innate cell engagers with the goal of achieving durable benefit for patients with cancer.

We recently announced that we will receive a payment in an undisclosed amount triggered by the achievement of a preclinical milestone under this collaboration. The funding that we've received to date from the Genentech collaboration provides an important source of nondilutive financing for Affimed, supporting further development of our own pipeline.

A common question that we hear from investors and industry is what does Affimed bring to Genentech. We believe this partnership shows that the value of our ROCK platform -- shows the value of our ROCK platform as well as our expertise in developing bispecific antibodies in unique formats and activating innate immunity with our CD16A-targeting approach to eliminate cancer cells. Our ROCK platform enables us to pursue clinically validated tumor antigens for which current therapies have shown limited efficacy and/or dose-limiting toxicities. We believe this is a key strategic differentiator with our innate cell engager approach that Affimed can bring to Genentech in order to help address certain targets that they could not pursue with their existing technologies.

This is indeed the same strategy that we're pursuing for -- with AFM24, our second innate cell engager and a potential treatment for multiple solid tumor malignancies. I will talk more about AFM24 later in the call. In short, we believe our clinical and corporate progress further demonstrates our expertise in innate immunity and the potential for therapeutics based on our novel CD16A-targeting innate cell engager approach to treat cancer. Before I turn the call over to Leila, let me briefly comment on our focus moving forward.

Looking ahead to the balance of 2019, our efforts are aimed at continuing to advance our development programs and achieving additional milestones with our collaboration partners, including moving our lead development candidate AFM13 into a market registration-directed monotherapy study, reporting clinical data updates from the ongoing monotherapy study and completed combination study with Keytruda and entering the clinic with AFM24.

Now I will hand it over to Leila to review the ASH data and outline our development plan for AFM13. Leila?

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Leila Alland, Affimed N.V. - Chief Medical Officer [4]

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Thank you very much, Adi. Before I review the key AFM13 data at ASH, I would like to start with an update on progress with AFM11, our CD19-targeting bispecific T cell engager.

AFM11 was being studied in 2 Phase I clinical studies for the treatment of patients with relapsed or refractory CD19-positive B cell non-Hodgkin lymphoma and relapsed or refractory acute lymphoblastic leukemia, respectively. As you may recall, AFM11 is on clinical hold after the occurrence of life-threatening serious adverse events in 3 patients. As presented at the 2018 ASH Annual Meeting, AFM11 showed 3 complete remissions at dose levels of 4, 5 and 6 in ALL patients. And overall, the safety profile of AFM11 appeared favorable in the ALL study.

We have worked closely with investigators to review all of the safety findings in detail. After having assessed all of the data from the AFM11 program, we recently submitted our response to the U.S. Food and Drug Administration with a request that the clinical hold be lifted and that clinical development of AFM11 may proceed in patients with ALL. I would like to take a moment to thank the Affimed team who worked hard to enable us to submit an extremely thorough response to the FDA that summarizes the clinical data from the 2 Phase I studies of AFM11 in detail.

Now let's move on to AFM13. In December, we and our academic collaborators presented clinical data at the 2018 ASH Annual Meeting supporting the potential of AFM13 as monotherapy and in combinations with a checkpoint inhibitor and cord blood-derived allogeneic NK cells, respectively. The data at ASH increased our confidence that AFM13 holds significant therapeutic value for patients with CD30-positive lymphomas.

Dr. Ahmed Sawas of Columbia University and the principal investigator of the Phase Ib/IIa trial of AFM13 in CD30-positive lymphomas with cutaneous manifestation highlighted interim data from the ongoing investigator-sponsored study, including clinical and translational data. An analysis of 9 patients with relapsed/refractory CD30-positive T cell lymphomas demonstrated that AFM13 could be safely administered and showed therapeutic activity as a single agent with an objective response rate of 44%. This included 1 complete response, 3 partial responses and 2 stable disease patients as determined by global response score. Dr. Sawas also discussed the immunological changes in the Tmr and peripheral blood.

We also provided updated data at ASH from our Phase Ib study of AFM13 in combination with Merck's Keytruda or pembrolizumab in patients with Hodgkin lymphoma. The combination was well tolerated, and most of the adverse events were mild to moderate in nature and manageable. Best response data from 24 patients treated at the highest AFM13 dose level as reported by central read showed an objective response rate of 88%, including complete metabolic responses in 46% and partial metabolic responses in 42% of patients.

Deepening of responses over time was observed in multiple patients, and patients who were previously transplant ineligible transitioned to transplant after achieving an objective response. The objective response rate of 88% and complete response rates of 42% and 46% by local and central reads, respectively, compare favorably to the historical data of pembrolizumab in a similar patient population with the complete response rate approximately double that of pembrolizumab. We're looking to continue the work of AFM13 in combination with anti-PD-1 in patients with Hodgkin lymphoma, and we're currently talking with multiple potential partners to take this combination forward.

The last data set at ASH that I would like to highlight was delivered during an oral presentation by Dr. Lucila Kerbauy, representing Dr. Katy Rezvani's group from MD Anderson Cancer Center. Together with MD Anderson, we have explored a novel premixed product that is comprised of expanded cord blood-derived allogeneic NK cells loaded with AFM13 to redirect their specificity against CD30-positive malignancies. We have shown that the complex of AFM13-armed NK cells is very stable, which is achieved through the high affinity targeting of CD16A, offering a unique, differentiating feature. This combination approach now may enable the injection of large numbers of armed NK cells into patients, with the goal of enhancing the tumor cell-killing effect and generating durable responses.

At the ASH meeting, Dr. Kerbauy presented very exciting preclinical data of AFM13 premixed of cord blood-derived NK cells that demonstrated promising signs of efficacy with decreased tumor growth in vitro and in vivo. These compelling data provide a strong rationale for investigating clinically the strategy of developing an off-the-shelf adoptive immunotherapy with AFM13-armed cord blood NK cells in patients with relapsed/refractory CD30-positive malignancies, including Hodgkin lymphoma. We anticipate the clinical study under the sponsorship of our clinical collaborators at MD Anderson to commence in the first half of 2019.

Now let's turn to the next steps for AFM13's clinical development plans, specifically the registrational pathway that we laid out at our Research & Development Day in December. Based on the preliminary feedback from the U.S. FDA and on the AFM13 monotherapy data presented at ASH, we are pursuing an initial registration path with AFM13 as monotherapy in patients with relapsed/refractory CD30-positive peripheral T cell lymphoma, or PTCL. We plan to initiate a Phase II study in the first half of 2019 evaluating the efficacy and safety of AFM13. And we'll enroll patients with relapsed/refractory CD30-positive peripheral T cell lymphoma or transformed mycosis fungoides, a subset of cutaneous T cell lymphoma. This is an open-label study with 3 treatment cohorts, 2 in patients with peripheral T cell lymphoma, or PTCL, and the third in patients with transformed mycosis fungoides subtype of cutaneous T cell lymphoma.

The first cohort includes 100 patients with relapsed or refractory PTCL whose tumors have high expression of CD30 defined as at least 5% of the tumor cells being CD30-positive. We plan to begin enrolling in the first half of 2019 with an interim efficacy analysis planned for mid-2020 which will assess objective response rates in the first 20 patients in that treatment group.

The second cohort includes 20 patients with relapsed or refractory PTCL whose tumors have lower CD30 expression defined as 1% up to less than 5% positivity for CD30. Here too we have an efficacy readout planned in mid-2020. If the efficacy data in this group looks similar to that in the high-expressing cohort, there may be an opportunity to combine the 2 cohorts of patients and to complete the registrational study sooner with a total of 100 patients with any level of CD30 positivity.

The third cohort includes patients with CD30-positive relapsed/refractory transformed mycosis fungoides. In this group, we plan to enroll 20 patients on an exploratory basis with the intent of getting an efficacy readout in 20 patients in the second half of 2020. The FDA expressed support for the potential for an accelerated approval path in patients with transformed mycosis fungoides. And if the data are encouraging, we will meet with the FDA to discuss the possibility of an accelerated approval in this indication. We believe that the results from this study, if positive, could form the basis for a biologics license application submission and support an accelerated approval given the unmet need for safe and effective new treatments in these hard-to-treat populations.

Our team is looking forward to initiating the registrational study for AFM13. We are committed to developing this potential treatment for patients as quickly as possible.

The broader clinical development strategy for AFM13 includes potentially expanding into other CD30-positive lymphoma indications and additional treatment lines with significant unmet need. In collaboration with strategic partners, we plan to investigate AFM13 in combination with other immunotherapy agents, such as an anti-PD-1 antibody or with adoptive NK cell transfer. As mentioned a few minutes ago, a study of cord blood-derived allogeneic NK cells in combination with AFM13 is planned, sponsored by our collaboration partner MD Anderson.

Our ROCK-generated antibodies, such as AFM13, offer important differentiation of high-affinity and long-lasting bindings to CD16A and NK cells without competition from circulating IgG. This differentiation enables the stable formation of a novel premixed product that is comprised of expanded cord blood-derived allogeneic NK cells loaded with AFM13 to redirect their specificity against CD30-positive malignancies. When injected into patients, the NK cells would be already armed to recognize the tumor cells, which we believe could be similar to the generation of CAR-NK cells. MD Anderson plans to initiate the clinical study of this approach in the first half of 2019.

Turning briefly to anticipated future clinical data updates. In the first half of 2019, we plan to report updated data from the combination study of AFM13 with pembrolizumab in Hodgkin lymphoma patients, and we expect additional data from Columbia University's study investigating AFM13 as monotherapy in patients with CD30-positive lymphoma.

Now I will hand the call back to Adi.

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Adi Hoess, Affimed N.V. - CEO, MD & Member of Management Board [5]

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Thank you very much, Leila. Beyond AFM13, we are making good progress with our second innate cell engager, AFM24. I'd like to briefly comment on why we are so enthusiastic about this program as we continue to anticipate completing IND-enabling studies of AFM24 by midyear 2019 to support the initiation of a first-in-human study in the second half of 2019.

AFM24, like all of the innate cell engagers developed from our ROCK platform, enable targeting of clinically validated tumor antigens for which current therapies have shown limited efficacy due to resistant and/or dose-limiting toxicity. AFM24 is designed to treat patients with a variety of EGFR-expressing solid tumors by a new mechanism of action of binding to EGFR, indeed including binding to EGFR variant III, rather than inhibition of EGFR-mediated signal transduction. We believe AFM24 has the potential for broader efficacy through higher potency at both high and low EGFR expression levels and in KRAS mutant tumors as well as a more favorable safety profile as compared to current therapeutic anti-EGFR monoclonal antibodies.

We will present data at the American Association for Cancer Research Annual Meeting 2019 that highlight these differentiating features of AFM24 versus standard of care anti-EGFR therapies, such as cetuximab, including tumor cell killing independent of RAS mutational status, induced tumor lysis through antibody-dependent cellular cytotoxicity, or ADCC, and antibody-dependent cellular phagocytosis, ADCP, as well as toxicology studies demonstrating a favorable safety profile. Also at AACR, we will present with our collaboration partners from Washington University School of Medicine data that describe NK cell functional responses to tumor cells triggered by AFM13.

Now I will hand it over to Florian to review our financial results.

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Florian H. M. Fischer, Affimed N.V. - MD, CFO & Member of Management Board [6]

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Thank you, Adi. Affimed's consolidated financial statements have been prepared in accordance with IFRS as issued by the International Accounting Standards 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 here in this call, unless otherwise noted, will be in euros.

We remained well capitalized in a strong cash position. Cash, cash equivalents and current financial assets totaled EUR 108.8 million as of December 31, 2018, compared to EUR 39.8 million as of December 31, 2017. In October 2018, we received the initial upfront payment and other near-term committed funding total USD 96 million from Genentech. In March 2019, we announced that Affimed will receive a payment in an undisclosed amount triggered by the achievement of a preclinical milestone under the Genentech collaboration. We anticipate that our cash, cash equivalents and current financial assets as of December 31, 2018, will enable Affimed to fund its operations, including clinical development and early development activities, into 2021 assuming all of the company's programs advance as currently contemplated.

Net cash from operating activities was EUR 49.4 million for the 12 months ended December 31, 2018, compared to net cash used in operating activities of EUR 25.5 million for the 12 months ended December 31, 2017. The amount in 2018 includes an initial upfront payment and committed funding of EUR 83.2 million from the Genentech collaboration. We recognized EUR 21.8 million as revenue from the Genentech collaboration in 2018 and EUR 61.4 million under the contract liabilities which will be recognized as revenue in subsequent periods. Total revenue was EUR 23.7 million for the year ended December 31, 2018, compared to EUR 2 million for the year ended December 31, 2017.

R&D expenses were EUR 35.1 million for the year ended December 31, 2018, compared to EUR 21.5 million for the year ended December 31, 2017. The increase was related to higher expense for the AFM13 and AFM11 clinical development activities as well as early-stage development and discovery activities.

G&A expenses were EUR 9.6 million for the year ended December 31, 2018, compared to EUR 8 million for the year ended December 31, 2017. This increase was primarily related to higher legal and consulting expenses.

The net loss was EUR 19.5 million or EUR 0.32 per common share for the year ended December 31, 2018, compared to a net loss of EUR 30.2 million or EUR 0.69 per common share for the year ended December 31, 2017. The decrease in net loss was primarily related to significantly increased revenue partially offset by higher spending on R&D and G&A expenses. The weighted number of common shares outstanding were 60.5 million for the year ended December 31, 2018.

And with that financial overview, I will now turn the call back over to Adi for brief concluding remarks. Adi?

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Adi Hoess, Affimed N.V. - CEO, MD & Member of Management Board [7]

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Thanks so much, Florian. As you heard, we've had a quite exciting 2019 (sic) [2018], and we're looking forward to another exciting year 2019. Thanks for -- thanks again, everyone, for joining us today. We indeed continue to make progress across a number of areas, including clinical, corporate and financial. And we look forward to providing additional updates in the near future.

We will now open the call to take some questions. Operator?

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Questions and Answers

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Operator [1]

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(Operator Instructions) And your first question is from the line of Maury Raycroft from Jefferies.

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Maurice Thomas Raycroft, Jefferies LLC, Research Division - Equity Analyst [2]

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Congrats on the progress. First question is for AFM24. So you've noted activity in RAS-mutant cell lines and also potential in a few different indications such as colorectal cancer, lung cancer, head and neck, GBM and PMBC (sic) [PBMC]. I'm just wondering if you could talk more about strategic considerations for AFM24. I guess, how do you anticipate the first-in-human study to be designed? And do you have strong thoughts on what the next steps could be after the initial trial?

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Adi Hoess, Affimed N.V. - CEO, MD & Member of Management Board [3]

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Thanks, Maury, for asking here. I will hand over to Leila to give you answers in terms of our planned clinical development as much as we can.

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Leila Alland, Affimed N.V. - Chief Medical Officer [4]

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Yes. Thanks, Maury. As you pointed out, there's a number of indications with high unmet need where AFM24 could be an important new therapy. And so with that, we've been having ongoing discussions with thought leaders and clinical trial investigators about where to prioritize the indications for AFM24. So those discussions are still ongoing. And we're actively designing the clinical study to be included in the IND, which is on track for submission mid this year.

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Maurice Thomas Raycroft, Jefferies LLC, Research Division - Equity Analyst [5]

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Got it. And do you anticipate the first-in-human study to be more about all-comers and signal seeking then, I'm assuming?

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Leila Alland, Affimed N.V. - Chief Medical Officer [6]

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Yes, those discussions are still ongoing. But again, as I said, there's a number of opportunities where we would see that signal for efficacy and including, as you pointed out, data supporting the activity in populations with high unmet need, such as those with RAS-mutated colorectal cancer are of high interest to us.

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Maurice Thomas Raycroft, Jefferies LLC, Research Division - Equity Analyst [7]

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Understood. Okay. And then for the AFM13 abstract at AACR with Washington University, that goes into a lot of detail in characterizing NK cell variables and how these could influence efficacy. I guess, how translatable are those data and the findings in those studies? And are you filing IP based on some of the findings in the abstract?

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Leila Alland, Affimed N.V. - Chief Medical Officer [8]

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Well, as you pointed out, these are preclinical data. And the proof is in the clinical trial and what we see there. And that's where we've been focusing in more recent times on translational aspects of our AFM13 studies such as being done in the Columbia study as well as in the registrational trial going forward and in the MD Anderson trials.

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Adi Hoess, Affimed N.V. - CEO, MD & Member of Management Board [9]

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So Maury, in order to be a bit more specific without being very specific, what we're doing is with AFM13, we are in the process of understanding how NK cells become activated, what's important for their activation, what kind of cell surface markers are changing. So it gives us a much broader picture on how these NK cells ideally are to be, let's say, activated. We have learned a lot that the activation with an innate cell engager can in part or, let's say, probably also in full, activate dysregulated and dysfunctional natural killer cells. So this is a very important finding. And we can have these studies now done with cells from healthy donors but also from patients. So there is a variety of investigations ongoing. And when the poster is being presented, it is clearer in order to explain what the learnings are from these experiments and how we use them in the future, but it's a part of an bigger effort that we are entertaining. And as I just may recall our information that we are giving with this premixing of natural killer cells, that we have learned that this complex isn't -- not only stable, but also remains active as shown by data for at least 7 days. So this is very unusual that you can have a premixed complex and the antibody stays on the surface of natural killer cells, and it looks like after 7 days that it is as active as if you would freshly prepare such a premixed formulation. So that gives us an option to develop product based on a premixed formulation and also potentially have a novel IND on such premixed formulations, which also gives rise to a novel IP, by the way. So that's the idea behind all these efforts.

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Maurice Thomas Raycroft, Jefferies LLC, Research Division - Equity Analyst [10]

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Got it. Yes, looking forward to that poster. And just a last quick question on the monotherapy trials that you're getting ready to start. Just wondering if you can comment on how many sites you anticipate for the studies. And I was wondering if there's a patient registry out there for TMF for these patients, if you have them on the radar or if it's going to be a challenge to find some of the patients.

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Leila Alland, Affimed N.V. - Chief Medical Officer [11]

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Yes, so we're planning to do a global study. So there will be multiple sites in the U.S. and outside of the U.S. We've done quite a lot of work to understand what the top centers are for recruitment based on experience from others and from our KOL network. And so we're confident that we're going to the right sites and we'll be able to enroll the study quickly.

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Operator [12]

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

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Nicholas M. Abbott, Wells Fargo Securities, LLC, Research Division - Associate Analyst [13]

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It's Nick on for Jim this morning. First question, in terms of the PTCL update from Columbia later this year, should we expect to see data on more patients?

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Leila Alland, Affimed N.V. - Chief Medical Officer [14]

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Yes, so as stated, this is an investigator-sponsored study, so I can't really comment on what will be in the final presentation. But as stated, the data will be presented in the first half of this year, and we'll have an update to both clinical data as well as translational data.

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Nicholas M. Abbott, Wells Fargo Securities, LLC, Research Division - Associate Analyst [15]

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Okay. And then can you remind us what the dosing will be in the proposed PTCL trials of AFM13?

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Leila Alland, Affimed N.V. - Chief Medical Officer [16]

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Yes. So we've done quite a lot of work to understand what the optimal Phase II dose is to take forward. So we've done detailed population PK analyses and exposure-response analyses. And with that, as you know, we have quite a broad therapeutic window for AFM13, where we've seen responses in as low as a dose of 1.5 milligrams per kilogram and then up to 7 milligrams per kilogram. So we've looked at all of that data. And with that, we've defined a dose that's actually also more convenient for caregivers, which is other than a per-kilogram dose, it's a flat dose. And that's the dose that we're taking forward.

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Nicholas M. Abbott, Wells Fargo Securities, LLC, Research Division - Associate Analyst [17]

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And I think the -- in the Columbia study, I think dosing was limited to 6 months. Is that correct? Presumably, there's no limit on the duration of dosing.

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Leila Alland, Affimed N.V. - Chief Medical Officer [18]

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Yes, that's an important point. So with the Columbia study, given that, that was an exploratory, first-time study in T cell lymphoma, the duration of treatment was more limited in that trial. In the registrational study, we would treat patients as long as they're tolerating treatment and haven't progressed.

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Nicholas M. Abbott, Wells Fargo Securities, LLC, Research Division - Associate Analyst [19]

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Okay. And then last question on AFM11, can you provide a little bit more detail on what you proposed to the FDA to reinitiate the ALL trial? And what do you need to see -- if we commit to a registration trial, what do you think the timing of such a decision might be?

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Leila Alland, Affimed N.V. - Chief Medical Officer [20]

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Yes, sure. So we submitted the complete response document to the FDA in early March, and we're waiting for the FDA's response. Now in their response, they could have additional questions or they could be in agreement with our proposal. And we'll provide a further update as soon as we receive the final FDA feedback and we know the status of the clinical hold.

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Operator [21]

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Your next question is from the line of Do Kim of BMO Capital.

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Guyn Kim, BMO Capital Markets Equity Research - Analyst [22]

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First, on AFM24, to follow up on the earlier line of questions, in the discussions with investigators for your clinical plan, is there a possibility of doing a basket study of all EGF tumor types?

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Leila Alland, Affimed N.V. - Chief Medical Officer [23]

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Yes, that's something that we've definitely been discussing, and that's one of the options that we're considering. We haven't finalized the protocol, and so I don't want to prematurely say what the final study design is. But that's certainly an option for us, yes.

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Guyn Kim, BMO Capital Markets Equity Research - Analyst [24]

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Okay. And maybe for AFM13, what would in your mind be the efficacy hurdle for PTCL and TMF for a potential accelerated approval?

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Leila Alland, Affimed N.V. - Chief Medical Officer [25]

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Are you asking -- I'm sorry. Can you just say that again? You faded out a little bit.

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Guyn Kim, BMO Capital Markets Equity Research - Analyst [26]

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Sorry. Just what in your mind do you think are the efficacy hurdles for PTCL and TMF to get accelerated approval?

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Leila Alland, Affimed N.V. - Chief Medical Officer [27]

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Yes, that's a great question. So as you're probably aware, the currently approved agents in relapsed or refractory peripheral T cell lymphoma which were granted accelerated approval based on objective response rates had objective response rates only in the 25% to 30% range and are each associated with significant toxicities. So one of the reasons that we're excited about AFM13 and the data that we've seen in this indication is we see an opportunity to demonstrate improved response rates over these currently approved agents and with a more tolerable safety profile. The precise magnitude and durability of response will be topics of further discussions with the FDA, and we plan to have those discussions after completing the interim analysis from the Phase II study.

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Guyn Kim, BMO Capital Markets Equity Research - Analyst [28]

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Okay. And last question on the combination study with cord blood NK cells. I was hoping you could talk more about the preparation of the product, whether the NK cells will be pre-induced to memory like and if you plan on enriching the product for NK cells that are already down to AFM13.

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Leila Alland, Affimed N.V. - Chief Medical Officer [29]

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That's a lot of technical details that I'm not sure I'm the best person to address, but it will be following the approach that was used in the preclinical study that was presented at ASH. So I'm sure some of the detail is in that presentation and that we could share with you after the call. And if you need additional details about something, I have to get from MD Anderson.

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Operator [30]

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Your next question is from the line of Peter Lawson of SunTrust.

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Peter Richard Lawson, SunTrust Robinson Humphrey, Inc., Research Division - Director [31]

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Just to follow up on the PTCL question around the hurdle, would that be the same, you think, for the CD30-high and CD30-low cohorts? And I may have missed it, but what do you think that hurdle is for TMF?

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Leila Alland, Affimed N.V. - Chief Medical Officer [32]

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Yes, so for the high versus the low, I mean, again, I think the challenge is that there's really very limited therapies for these patients. And so, again, I think that we'd be looking at that efficacy hurdle based on the currently approved agents, and we expect that we would see better activity in each of those populations to take that forward. For transformed mycosis fungoides specifically, there are no approved agents. So it's really hard to know what efficacy hurdle we're looking at there and -- but I would expect it to be low, again, based on the high unmet need and the lack of agents in that indication.

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Peter Richard Lawson, SunTrust Robinson Humphrey, Inc., Research Division - Director [33]

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Got you. And then do you get any sense which of those kind of 3 arms would recruit faster and where we could potentially see data first?

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Leila Alland, Affimed N.V. - Chief Medical Officer [34]

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Yes, so I think that for PTCL, just based on the numbers of patients with that indication compared to transformed mycosis fungoides, I mean, there's a lot more patients with PTCL. So we're confident that we can enroll the PTCL population quickly. And with the 2 arms of the study, once the CD30 testing is done, patients would go into one or the other arm. So we expect both of those arms to recruit quickly. For transformed mycosis fungoides, there's been a lot of excitement given that there's not competition from other trials in that indication. But I think we have to get into it before we can really do a good analysis of the time lines for enrolling transformed mycosis fungoides.

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Peter Richard Lawson, SunTrust Robinson Humphrey, Inc., Research Division - Director [35]

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Got you. And then just on the adoptive NK cell combination, when do you think we could see data for that trial? I know it's probably out of your control to a certain degree.

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Leila Alland, Affimed N.V. - Chief Medical Officer [36]

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Yes, well, what I can say is that Dr. Nieto, the principal investigator, has been working extremely fast and diligently to get the study opened at MD Anderson. And so I know that this is a very high priority for him and for the cell therapy department, so I'm confident that it will enroll quickly. And again, I think we have to get the study open and see how quickly they're getting those patients on.

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Operator [37]

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Your next question is from the line of Yale Jen of Laidlaw & Company.

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I-Eh Jen, Laidlaw & Company (UK) Ltd., Research Division - MD of Healthcare Research & Senior Biotechnology Analyst [38]

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My first question is for the TMF, and recall that during the Analyst Day, that you think there'll be 20 patients. And if the data is robust, you could seek for a sort of accelerated approval. My question to you is that do you feel 20 patients will be sufficient given this is a very rare disease?

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Leila Alland, Affimed N.V. - Chief Medical Officer [39]

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Yes, I mean, remember that this is not the only cohort that would be enrolling in the study. So equally important for an approval is to have a robust safety database, which will be provided by all of the patients already treated with AFM13 as well as those on the PTCL cohorts of the study. So right now that's an assumption. We have to go back and have those discussions with FDA around the precise number. But yes, that's in our assumption, and that's where we designed the study.

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I-Eh Jen, Laidlaw & Company (UK) Ltd., Research Division - MD of Healthcare Research & Senior Biotechnology Analyst [40]

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Okay, great. That's helpful. And also just curious, what will be the venue for presenting the Columbia data this first half of this year as well as the combo data? Will that be a medical conference or simply just a press release?

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Leila Alland, Affimed N.V. - Chief Medical Officer [41]

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That will be at an upcoming conference.

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I-Eh Jen, Laidlaw & Company (UK) Ltd., Research Division - MD of Healthcare Research & Senior Biotechnology Analyst [42]

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Anything more specific at this point, or it's too early to [design]?

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Leila Alland, Affimed N.V. - Chief Medical Officer [43]

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Yes, I think we've just guided to the first half of 2019.

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I-Eh Jen, Laidlaw & Company (UK) Ltd., Research Division - MD of Healthcare Research & Senior Biotechnology Analyst [44]

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Okay. And the last question here is for AFM24. Should we anticipate a rather typical 3 plus 3 time -- type of sort of dose testing? Or that's not necessarily the basic design of the study later on?

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Leila Alland, Affimed N.V. - Chief Medical Officer [45]

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Yes, the protocol development, as I said, is ongoing. And so yes, we will define that in the future once it's been finalized.

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Operator [46]

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And your next question is from the line of Daina Graybosch of SVB.

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Daina Michelle Graybosch, SVB Leerink LLC, Research Division - MD & Senior Research Analyst [47]

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The first one is just a clarification. I think I heard for AFM11 that you'll be asking for the clinical hold to be lifted in adult ALL. Are you also planning to continue to move forward in non-Hodgkin's lymphoma?

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Leila Alland, Affimed N.V. - Chief Medical Officer [48]

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Yes, that's a great question. We proposed to the agency that we'll move forward to resume testing in ALL. However, we intend to close the lymphoma study and no longer evaluate the intermittent dosing schedule that has been employed in the lymphoma study. Now, of course, we could reinitiate development in patients with relapsed/refractory lymphoma at a later time point, and we would consider this only after establishing safety and tolerability and preliminary efficacy in patients with ALL on the continuous schedule.

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Daina Michelle Graybosch, SVB Leerink LLC, Research Division - MD & Senior Research Analyst [49]

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Got it. The next one is theoretical...

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Adi Hoess, Affimed N.V. - CEO, MD & Member of Management Board [50]

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Just a quick comment from my side on that. We have run this study with different dosing regimes. And we have always had the idea of continuing 1 of the 2 dependent on which dosing risk -- regime is offering the best risk-benefit ratio. So what we're doing is in line with our original strategy that we will establish, first, a safe and an effective dose in either of the indications. And once that's established, we will go back to the other one. So it has happened in ALL, and that's why we are now continuing with ALL. So it's according to our plans.

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Daina Michelle Graybosch, SVB Leerink LLC, Research Division - MD & Senior Research Analyst [51]

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Maybe a follow-up question then. Can you remind us the differences in dosing between the 2 and why you chose the ALL one to go forward with now?

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Adi Hoess, Affimed N.V. - CEO, MD & Member of Management Board [52]

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Well, the choice was based on recent data that we have published at ASH where we have seen complete responses. So we are at an active dose where we are already seeing, as I said, responses. And it is now the time to refine that doses. And I'm not sure if we ever have detailed the difference in the doses, but -- we can do this at another time point in time to clarify that, how this will continue. But at the moment, the focus is just to get the dosing schemes established for 1 of the 2 indications.

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Daina Michelle Graybosch, SVB Leerink LLC, Research Division - MD & Senior Research Analyst [53]

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Makes sense. The next question is a theoretical one on AFM24. I think theoretically, do you think it has potential to be combined with some of the signaling-targeted agents against KRAS and EGFR, let's say, osimertinib or the new KRAS with the mutation inhibitors or anything else that you think that would give synergy with AFM24?

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Leila Alland, Affimed N.V. - Chief Medical Officer [54]

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Yes, I mean, I think there's a number of opportunities where to combine AFM24. Some of that will be based on preclinical data that's ongoing, looking at various combinations. But I think at this point, we have not yet decided which combinations to prioritize. However, I share the sentiment that it is important to get into combinations fairly early in the development path. With that being said, I think we have an opportunity to see the best single-agent activity for AFM24 as well. And so it's important that we also invest in defining the single-agent activities as well as the combinations.

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Adi Hoess, Affimed N.V. - CEO, MD & Member of Management Board [55]

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And just continuing with what Leila has been explaining in more like a general approach that we're taking with our innate cell engagers, as you have seen, we have historically already done combinations of AFM13, but also of AFM24 with checkpoint inhibitors with specific cytokines and also with adoptive NK cells. So there are indeed a variety of options already investigated. And as Leila has pointed out, we are looking in order to initiate some combination studies early on. Once we have early signs of a good safety, then we will pursue this path in parallel. But it's yet too early for us to go beyond our general approach that we have taken and be more specific for AFM24.

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Daina Michelle Graybosch, SVB Leerink LLC, Research Division - MD & Senior Research Analyst [56]

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That makes sense. And one last question. You mentioned again the partnership collaborations to go forward in combination with a checkpoint in Hodgkin's lymphoma. I think you said that you're talking to several potential partners. And I wonder if you can talk at all about sort of what is -- what the major point of negotiation or discussion is with those partners. Is it you looking for a certain deal? Is it partners getting to know the data? Any more details on how that's progressing?

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Adi Hoess, Affimed N.V. - CEO, MD & Member of Management Board [57]

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Yes. It's -- thanks for this question. And indeed, yes, this is a -- these are ongoing discussions. And obviously, there are multiple players out there that have either PD-1 or PD-L1 antibodies, and it's yet too early to finally decide on that. So it comes -- there are multiple factors contributing to such a decision. Our focus at the moment is indeed to continue with AFM13 as a monotherapy and move forward with AFM13 in combination with adoptive NK cell. That has such high priority. And we believe that this represents a great opportunity for us and that -- so this -- getting this established and collecting, first, clinical data is very important for us in that. So at the one time, it's good to do such a partnership on PD-1, but we need to very carefully evaluate. And we want to keep to the potential of AFM13 as much as we can as, especially, the most recent data have been very promising.

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Daina Michelle Graybosch, SVB Leerink LLC, Research Division - MD & Senior Research Analyst [58]

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Got it. So can I read into that and say that we might not expect that pembro to go forward, maybe the adoptive [T cell] therapy is one that we could see going forward in Hodgkin's lymphoma?

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Adi Hoess, Affimed N.V. - CEO, MD & Member of Management Board [59]

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So at the moment, I can't point you in any kind of expectations with what's going on. It's just the focus that we're having, which is a monotherapy and a combination, we believe, as outlined, that we can generate data throughout the next 12 months on the respective studies already. And if -- so -- and if those data looks good, then we have a path forward, and the PD-1 combo is just another option in that context. So we're at the moment moving forward in this direction, discuss with the parties, see what their aspiration is and then we can finally decide. So we're still at early times in terms of these discussions. And on the other side, you mentioned if we are considering pembro or not. At that moment, we're just considering it broadly. Pembro is amongst it, so we're not precluding any type of collaboration here.

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Operator [60]

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There are no further questions at this time. Please continue.

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Adi Hoess, Affimed N.V. - CEO, MD & Member of Management Board [61]

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Greg, are you wrapping up?

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Gregory Gin, Affimed N.V. - Head of IR [62]

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Hi. Yes. So thank you for joining the call. We look forward to updating you on our next quarterly call and our continued progress in the first quarter, which will be in May. Adi, anything else?

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Adi Hoess, Affimed N.V. - CEO, MD & Member of Management Board [63]

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Perfect. Thanks a lot.

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Operator [64]

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That concludes the presentation. Thank you for participating. You may disconnect.