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Edited Transcript of AFMD earnings conference call or presentation 19-Nov-19 1:30pm GMT

Q3 2019 Affimed NV Earnings Call

Heidelberg Jan 7, 2020 (Thomson StreetEvents) -- Edited Transcript of Affimed NV earnings conference call or presentation Tuesday, November 19, 2019 at 1:30:00pm 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

* Cassandra Choe-Juliak

Affimed N.V. - Acting Chief Medical Officer

* Denise Mueller

Affimed N.V. - Chief Business Officer & President Affimed Inc.

* Florian H. M. Fischer

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

* Gregory Gin

Affimed N.V. - Head of IR

* Wolfgang Fischer

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

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Conference Call Participants

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* Daina Michelle Graybosch

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

* Jameson Kao

BMO Capital Markets Equity Research - Research Analyst

* Maurice Thomas Raycroft

Jefferies LLC, Research Division - Equity Analyst

* Nicholas M. Abbott

Wells Fargo Securities, LLC, Research Division - Associate Analyst

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Presentation

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Operator [1]

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Good day, and welcome to Affimed's Third Quarter 2019 Financial Results and Corporate Update Conference Call. (Operator Instructions) As a reminder, today's conference is being recorded. I'll 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, Carol. I'd like to welcome and thank everyone for joining us for Affimed's conference call to discuss the company's third quarter 2019 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 today with prepared remarks are Adi Hoess, Chief Executive Officer of Affimed; Cassandra Choe-Juliak, Acting Chief Medical Officer; and Florian Fischer, our Chief Financial Officer. We are also joined by Wolfgang Fischer, Chief Operating Officer and Acting Chief Scientific Officer; and Denise Mueller, Chief Business Officer, who will be available for questions and answers.

We will begin today's call with opening remarks from Adi on our progress during the quarter. Cassandra will provide updates on our clinical programs and then Florian will review the financial results and update our financial guidance, following which Adi will provide a few closing remarks. After the prepared remarks, we will host a Q&A session.

Before we start, let me review our safe harbor statement. Today's discussion contains projections and forward-looking statements regarding future events. These statements represent our beliefs and assumptions only as of the date of this discussion. Except as required by law, we assume no obligation to update these forward-looking statements publicly or to update the reasons why actual results could differ materially from those anticipated in the forward-looking statements, even if new information becomes available in the future.

These forward-looking statements are subject to risks and uncertainties, and actual results may differ materially from those expressed or implied in the forward-looking statements due to various factors, including, but not limited to, those identified under the section entitled Risk Factors in our filings with the SEC and those identified under the section entitled Cautionary Statement Regarding Forward-Looking Statement in our Form 6-K filed with the SEC earlier today. And with that, 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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Thank you very much, Greg, and good morning, everyone, and thank you for joining us for this -- for our third quarter earnings call. Before I begin, I would like to take a moment to introduce Dr. Cassandra Choe-Juliak, who is joining us on her first quarterly call as Acting Chief Medical Officer of Affimed. She will be succeeding Dr. Leila Alland effective November 30 this year, who will step down from her current role (technical difficulty) and will serve as a consultant for Affimed through January 2020 to ensure a smooth transition.

I wanted to thank Leila for her great contributions to our progress in the past 2 years of our program and, in particular, for building an exceptionally strong clinical development organization with a focus on clinical strategy, operations, biostatistics, clinical pharmacology and drug safety. I would also like to wish her success in her future endeavors.

Cassandra has over 13 years of experience in drug development and medical affairs in immuno-oncology/oncology for both hematological and solid tumor malignancies. Since joining Affimed in July 2017, Cassandra has made significant contributions to the clinical development strategy of all of our programs, and she has served as the clinical leader for the AFM13 development program. Cassandra's deep expertise in drug development as well as her strong leadership skills have been and will continue to be a tremendous asset to Affimed and our clinical team as we continue to advance our pipeline of innate cell engagers.

Now let me turn to the business update. As we reported, we made important progress executing our programs -- clinical programs for AFM13 and AFM24, in our collaboration with Genentech and in strengthening our cash position which allows us to fund operations at least for another 2 years.

I'll start with an update on AFM13, our lead product candidate and the most advanced CD16A binding innate cell engager in clinical development. We're very pleased to report today that patient dosing has started in our Phase II registration-directed study of AFM13 monotherapy. To achieve this important milestone has been a huge team effort and brings us one step closer to delivering a potential new treatment for relapsed and refractory patients with CD30-positive peripheral T-cell lymphoma who have very few treatment options.

The results of the Phase II study in PTCL, if positive, could form the basis for a biologic license application submission and support the possibility of an accelerated approval pathway for 13, given the unmet medical need for safe and effective new treatments in this hard-to-treat patient population.

Next, I'd like to briefly update you on the planned Phase I study to evaluate the combination of AFM13 with cord blood-derived allogeneic NK cells as an investigational treatment for patients with relapsed/refractory CD30-positive lymphoid malignancy.

The FDA has cleared an IND application for this trial with an IST run by the MD Anderson Cancer Center, which will be the first-ever clinical trial bringing together an innate cell engager, which is AFM13, and adoptive NK cell transfer. The cellular therapy approach of administering NK cells preloaded with AFM13 could address patients that either have low NK cell numbers or dysfunctional NK cells. This study could, therefore, address a much broader opportunity in CD30-expressing lymphomas, including Hodgkin lymphoma, T-cell lymphoma and B cell lymphoma.

Now let's move on to our second clinical-stage innate cell engager, AFM24, which recognizes both epidermal growth factor receptor, EGFR; and CD16A. We are pleased to report that we have received clearance of our IND in October. We are now proceeding with initiation of the Phase I/IIa clinical study of the first innate cell engager entering clinical development addressing patients suffering from EGFR-expressing solid tumors.

We conducted market research with key opinion leaders and they continue to highlight the tremendous medical need for novel therapies for such solid tumors. Based on the unique and innovative mechanism of activating the innate immune system, AFM24 has the potential to address limitations associated with other EGFR-targeted therapies.

Beyond AFM13 and AFM24, we are broadening our early-stage pipeline with additional innate cell engagers from our ROCK platform, which we're developing internally and with Genentech. For our internal pipeline, we have selected 2 new CD16A binding innate cell engager candidates, which we call AFM28 and AFM32. We plan to advance the first candidate into preclinical studies in 2020 with the aim of supporting a future IND submission.

The selection of the new development candidates follows our comprehensive evaluation opportunity of validating tumor antigens that could be a target for the innate immune response that are expressed in multiple hematologic and solid tumor malignancies, and for which current development therapies have shown limited efficacy and/or dose-limiting toxicity.

Switching briefly to our collaboration with Genentech. We recently announced the second milestone this year for the collaboration. Genentech exercised its final option for an exclusive target under our multi-program agreement to develop and commercialize novel NK cell engager-based immunotherapeutics, generated from our fit-for-purpose ROCK platform to treat multiple cancers. The target selection triggers a milestone payment in an undisclosed amount to us from Genentech.

We indeed look forward to achieving further progress with Genentech towards generating novel therapies that leverage the full potential of the innate immune system to help people living with cancer.

With an improved cash position, which Florian will elaborate on further in his prepared remarks, we have sufficient cash resources to build on our momentum and fund our operations at least into the fourth quarter of 2021.

Our available capital position as well as -- as well -- positions us well to further advance our clinical programs through milestones next year, including proof-of-concept data for AFM13 from our registration-directed study and safety and preliminary efficacy data from our first-in-human study of AFM24. This capital allows for the long-term investment in our earlier-stage pipeline programs as well.

I will now turn the call over to Cassandra to provide more detail on AFM13. Cassandra, please go ahead.

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Cassandra Choe-Juliak, Affimed N.V. - Acting Chief Medical Officer [4]

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Thank you very much, Adi. First, as Adi mentioned, we are very excited to initiate our Phase II registration-directed study of AFM13 as monotherapy in patients with relapsed or refractory CD30-positive peripheral T-cell lymphoma, or PTCL, with the dosing of the first patient.

This is a very important milestone for us for the relapsed/refractory patients with PTCL, their families and caregivers. These patients currently have extremely limited treatment options and poor survival. And as such, PTCL is an area of high unmet medical need.

This is an open-label study evaluating the efficacy of AFM13 in 3 treatment cohorts, with each cohort receiving weekly AFM13 infusions of 200 milligrams flat dose. The first cohort includes patients with relapsed or refractory disease whose tumors have high expressions of CD30, defined as at least 10% of the tumor cells being CD30-positive.

The second cohort includes patients with relapsed or refractory PTCL whose tumors have lower CD30 expression, defined as from 1% up to less than 10% CD30 positivity. As agreed with the FDA, the study is designed to allow a potential BLA filing based on treating 100 patients suffering from PTCL.

A prespecified interim efficacy analysis will assess objective response rates in the first 20 patients in each of the 2 PTCL treatment groups. If the efficacy data in the low CD30-expressing groups look similar to that of the high-expressing cohort, there may be an opportunity for us 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.

In addition to the 2 PTCL cohorts, the Phase II study will also enroll a cohort of patients with CD30-positive transformed mycosis fungoides, an aggressive subtype of cutaneous T-cell lymphoma, another group of patients with high unmet need. In this group, we plan to enroll 20 patients on an exploratory basis. And if the data are encouraging, we plan to meet with the FDA to discuss the possibility of an accelerated approval in this indication.

I'll now turn to the opportunity to combine our innate cell engagers with NK cell therapies. As we continue to advance innate cell engagers as monotherapies, our research and development efforts are also focused on understanding whether patients who don't respond to an innate cell engager might benefit from therapeutic approaches that combine with allogeneic NK cells. Such NK cell platforms are emerging and are in early stages of clinical testing by several groups and companies.

MD Anderson previously reported the results of a preclinical collaboration with Affimed, whereby a novel product consisting of AFM13 premixed with MD Anderson's cord blood-derived allogeneic NK cells was studied in models of CD30-positive malignancies and showed strong antitumor efficacy in an in vivo mouse experiment.

MD Anderson has received IND clearance for an investigator-sponsored Phase I clinical study, in which MD Anderson intends to administer a stable complex of AFM13 premixed with cord blood-derived allogeneic NK cells in different doses, that is different numbers of preloaded NK cells into patients with relapsed/refractory CD30-positive lymphoid malignancies.

Combining our innate cell engagers with allogeneic NK cells allows administration of a large number of activated NK cells and selectively target these NK cells against the patient's tumor. This novel approach has the potential to further improve response rates and durability of responses in patients with cancer.

We believe that such an NK cell combination approach could be valuable in combination with any of our innate cell engagers in order to optimize the potential of the innate immune system to fight cancer. I'll turn the call back to Adi. Adi, please?

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

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Thanks a lot, Cassandra. The next program I will discuss is AFM24, our tetravalent bispecific EGFR and CD16A-binding innate cell engager. AFM24 is designed to target EGFR-expressing solid malignancies by a novel and differentiated mechanism of action, that is by activation of innate immunity. This approach is differentiated from other EGFR-targeting approaches, including cetuximab, panitumumab or osimertinib, which all inhibit tumor growth by EGFR-mediated signal transduction inhibition.

Earlier this month, we announced FDA clearance of our IND application to start a first-in-human Phase I/IIa clinical study of AFM24 in patients with advanced cancers known to express [EGFR]. The initial goal of the planned clinical study is to determine the maximum tolerated dose and recommended Phase II dose of AFM24 as well as to evaluate the safety, pharmacokinetics, pharmacodynamics and preliminary efficacy.

AFM24 is designed to bind both tumor cells and innate immune cells with much higher affinity as described to date. Particularly, the high affinity to CD16A could be an important contributor to an improved outcome as shown for some other approaches recently.

With that, I will turn the call over to Florian for the financial overview. Florian?

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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 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 here in this call unless otherwise noted will be in euros.

We ended the third quarter with 17 -- with EUR 76.5 million in cash, cash equivalents and current financial assets as compared to EUR 108.8 million as of December 31, 2018. As we reported last week, we completed a public equity offering with net proceeds of approximately EUR 29 million. At the end of the third quarter, this would bring our pro forma cash position including the offering proceeds to approximately EUR 106 million.

We observed very high quality demand in this transaction, enabling us to further expand our excellent shareholder base. Based on our current operating and budget assumptions, we anticipate that our pro forma cash position as of September 30, 2019, will enable us to fund our planned clinical development and early development activities at least into the fourth quarter of 2021.

Net cash used in operating activities was EUR 30.6 million for the 9 months ended September 30, 2019, compared to net cash used in operating activities of EUR 24.9 million for the 9 months ended September 30, 2018. The increase is primarily due to higher cash expenditure for research and development efforts.

Total revenue was EUR 2.1 million for the 3 months ended September 30, 2019, compared to EUR 300,000 for the 3 months ended September 30, 2018. The increase in revenue is attributable to the recognition of EUR 1.9 million as revenue from the Genentech collaboration in the third quarter of 2019.

R&D expenses for the third quarter 2019 were EUR 11.7 million compared to R&D expenses for the third quarter of 2018 of EUR 9.8 million. The increase was primarily related to higher expenses related to manufacturing activities for clinical study material for AFM13, start-up activities for AFM13 registrational study in PTCL and early-stage development and discovery activities.

G&A expenses for the third quarter of 2019 were EUR 2.8 million compared to EUR 2.4 million for the third quarter of 2018. Net loss was EUR 10.9 million or EUR 0.17 per common share for the third quarter of 2019 compared to a net loss of EUR 12 million or EUR 0.19 per common share for the third quarter of 2018. Weighted number of common shares outstanding were 62.4 million for the quarter ended September 30, 2019.

And with that, I would like to turn the call back over to Adi for closing comments before we open up the call for questions. Adi?

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

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Thanks a lot, Florian. Our differentiated CD16A-binding innate cell engagers could transform current I-O approaches by actualizing the untapped potential of the innate immune system to give back patient -- to give patients back the innate ability to fight cancer.

We're committed to bringing our drugs to patients, thereby addressing unmet patient needs in treating hematologic and solid tumor malignancies. We're working to achieve this by advancing our novel and differentiated innovations and are focused on delivering on data milestones in 2020 in all of our programs and in our collaboration with Genentech.

To that end, over the past 2 months, the Affimed team has delivered on a number of clinical development milestones. We have strengthened our drug development teams and solidified our balance sheet, positioning us well to further execute our AFM13 and AFM24 programs as well as to advance our internal and partner pipeline. We take great pride in the progress we've made and the advancement of our development programs.

We would now be happy to address any questions that callers may have. Operator?

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Questions and Answers

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Operator [1]

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(Operators Instructions) And the first question comes from the line of Maury Raycroft.

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

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Congrats on the progress. So first question is on the Phase II registration-directed study. You've got a lot of clinical experience with AFM13. Just wondering if you can talk about where you are starting out with the registrational trial. How many sites do you already have up and running? And how should we think about site rollout in different regions going forward?

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Cassandra Choe-Juliak, Affimed N.V. - Acting Chief Medical Officer [3]

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Sure. Thank you for your question. We just started the process of getting the study off the ground. We treated our first patient last week at Columbia University. We are anticipating 70-plus sites in the United States; in Europe, both Western and Eastern; and also in Asia Pacific, sites that are in countries such as Germany, France, Spain and also in South Korea and Asia Pacific. We're working hard to get these sites off the ground as fast as possible. And we will be providing those updates in the coming months.

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Maurice Thomas Raycroft, Jefferies LLC, Research Division - Equity Analyst [4]

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Got it. Okay. And then for the AFM13 and allogeneic NK cell combo trial, any new clarity on when you could dose -- when MD Anderson could dose the first patient there and potential time lines for that study?

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Cassandra Choe-Juliak, Affimed N.V. - Acting Chief Medical Officer [5]

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Sure. This is an investigator-sponsored trial, sponsored by the MD Anderson. So as such, in general, as you know, for most ISTs, we really can't really speculate or comment on the timing. We can say that we're working very closely with them on a day-by-day basis in close communications. And they're working very hard to open the study as soon as possible. And we expect to inform you when the study has treated its first patient and will be updated on, I'm sure, clinicaltrials.gov.

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Maurice Thomas Raycroft, Jefferies LLC, Research Division - Equity Analyst [6]

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Got it. Great. And last question is just on AFM24. Just wondering when that study could post to clinicaltrials.gov and if you could provide any clarity on the types of patients you may try to enroll for that study depending on tumor type, mutation status and prior treatments. And then what would the threshold be for you to report data from that study? I guess how many patients will you have had to have treated?

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Wolfgang Fischer, Affimed N.V. - MD, COO & Member of Management Board [7]

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Maury, this is Wolfgang. Thank you for your question -- I mean many questions. So let me start with the first one regarding the initiation of this clinical trial. As we have heard earlier, we have the clearance of the IND and we plan to initiate this study in Q1 2020.

Regarding the indication in this Phase I, right, where we have the primary objective to look for safety, recommended Phase II dose and then tolerability and PK, we are looking for patients with known -- where EGFR expression is a validated target. And also here, we include patients with and without RAS mutations.

And in terms of first data or signals, right, I mean as you know, it depends on recruitment speed, et cetera, but we could have early safety data, right, maybe late 2020. And when it comes to clinical activity or clinical signs of activity, we can't comment on that because we just don't know. Does that answer your questions? Or did I miss one?

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Maurice Thomas Raycroft, Jefferies LLC, Research Division - Equity Analyst [8]

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No. That's very helpful.

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Operator [9]

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And the next question comes from the line of Daina Graybosch from SVB Leerink.

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Daina Michelle Graybosch, SVB Leerink LLC, Research Division - MD & Senior Research Analyst [10]

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A couple of them. First on the NK cell program with MD Anderson. MD Anderson recently licensed their CAR-NK technology that's built on the cord blood NK cells to Takeda. I'm wondering if that licensing event has any impact on your program or if you get a good signal how you would ultimately commercialize an NK engager with the cord blood NK cell therapy.

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Adi Hoess, Affimed N.V. - CEO, MD & Member of Management Board [11]

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Denise, can you take that question or shall I take it?

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Denise Mueller, Affimed N.V. - Chief Business Officer & President Affimed Inc. [12]

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Sure. No, I got it. I was just waiting. This is Denise Mueller. Thanks for the question. The impact of the deal with Takeda has no relevance or impact on our collaboration with MD Anderson. While the CAR-NKs come off a -- the same platform as the NK cell product itself, they're engineered NK cells, and it's a product-by-product license with Takeda. We have -- continue to have full support and collaboration from MD Anderson. And there was a second part of your question, which is about commercialization. Is that correct? Just so we can answer it.

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Daina Michelle Graybosch, SVB Leerink LLC, Research Division - MD & Senior Research Analyst [13]

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Yes. Yes. Like, ultimately, if we get a good signal, how does this translate into an actual commercial product? Is that with MD Anderson? Or would you look to other companies, for instance?

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Denise Mueller, Affimed N.V. - Chief Business Officer & President Affimed Inc. [14]

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So we have access to this NK cell product. We are working through if we get a good signal, what could -- what the potential is to license that and commercialize that. As you probably know, MD Anderson doesn't commercialize any products themselves. But we would wait to make that assessment to see the activity and how it performs with AFM13. And of course, to look at the status of the off-the-shelf, the ability to make the NK cells off the shelf, that would also drive our decision on commercialization.

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Daina Michelle Graybosch, SVB Leerink LLC, Research Division - MD & Senior Research Analyst [15]

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Got it. And my next question is, you mentioned some new programs coming out of discovery through new targets. I'm wondering if you could talk about your plan for bringing those forward. Is the plan to bring them forward sequencing after AFM24 internally? Or are you looking for some development partners to accelerate that?

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Adi Hoess, Affimed N.V. - CEO, MD & Member of Management Board [16]

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So I can step in here. So these were -- these were targets carefully selected by Affimed on a -- in a significant effort. So we have done analysis of certain indications where innate -- the innate immune system has been involved. And we think that this is a very valuable target for Affimed. And our plans are for the time being to bring 2 of these molecules forward to a potential IND filing.

So we are not kind of contemplating for the time being that we will partner those. However, what we are realizing is that parties are interested in discussing those opportunities. So we are somewhat flexible, but we have a long-term look so that we at least can file the IND.

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Operator [17]

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And the next question comes from the line of Jameson Kao from BMO Capital Markets.

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Jameson Kao, BMO Capital Markets Equity Research - Research Analyst [18]

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This is Jameson on for Do. And congrats on the progress. So first one, how do you see AFM24 fitting in the treatment landscape for EGFR cancers?

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Wolfgang Fischer, Affimed N.V. - MD, COO & Member of Management Board [19]

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Thank you for your question. But based on the mode of action of AFM24, right, which is different of currently EGFR targeting therapies, meaning that the EGFR targeting therapies, right, mainly act through the inhibition of signals reception of the EGF receptor. AFM24, on the other side, right, is really engaging NK cells with the tumor cells and then activating these NK cells to kill the tumors.

What we also have seen in our IND-enabling studies, right, we tested AFM24 in cell lines with and without RAS mutations. And we clearly can see that both cells, right, carrying mutations or not carrying mutations are killed by AFM24 in the presence of NK cells. So it seems that some of the limitations or potential limitations could be overcome by AFM24.

On the second -- the second point is here that when we looked at toxicology and tolerability, we have seen in cyno studies that AFM24 is very tolerable and very safe. And we have seen in our GLP tox study no toxicity. And we use similar dosing compared to the historic tox studies, which have been done with cetuximab. So overall, we have a molecule which could overcome RAS mutations on one side and also a molecule which is very tolerable and safe. Does that answer your question?

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Jameson Kao, BMO Capital Markets Equity Research - Research Analyst [20]

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Yes. That was very, very helpful. Just a quick follow-up for your earlier pipeline assets. When do you guys think about -- think you're going to disclose the targets for AFM28 and 32?

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Adi Hoess, Affimed N.V. - CEO, MD & Member of Management Board [21]

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Indeed, we haven't decided on that. We've outlined -- so this was quite an extensive work in order to reduce the many potential targets out there just at the moment to 2 or 3 different ones. We do not want to share that in the public domain. So it could also be -- as we haven't taken any decision, it could take a while until we will disclose those.

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Operator [22]

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

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Nicholas M. Abbott, Wells Fargo Securities, LLC, Research Division - Associate Analyst [23]

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This is Nick on for Jim this morning. First on AFM24, do you plan to file a CTA so that you can engage, I am assuming, some very enthusiastic European investigators in the EGFR space?

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Wolfgang Fischer, Affimed N.V. - MD, COO & Member of Management Board [24]

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Yes. So for the -- thank you for your question. For the Phase I study, right, which we are going to initiate, we have 4 sites, 2 of them in the U.S., one of them in Spain and one of them in the U.K. In the U.K., it's de Bono, and in Spain, it's [Tabernero]. And then we have UCLA and UCI.

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Nicholas M. Abbott, Wells Fargo Securities, LLC, Research Division - Associate Analyst [25]

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Okay. You mentioned pharmacodynamics. So will the study require mandatory on-treatment tumor biopsies?

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Wolfgang Fischer, Affimed N.V. - MD, COO & Member of Management Board [26]

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Yes. We are looking into tumor biopsies. And we have a comprehensive, correlative science program associated to our study. And this includes, on one side, biopsies and the analysis of biopsies. And on the other side, we are evaluating markers in the innate immunity, but also in -- to see how the phenotype of these cells is changing, et cetera, in order to detect changes during the treatment with AFM24. Does that answer your question?

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Nicholas M. Abbott, Wells Fargo Securities, LLC, Research Division - Associate Analyst [27]

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Yes. No, it does. And the last one on 24. How important do you think activation of adaptive immunity is going to be in these solid tumors? And how do you think about deployment of T cell checkpoint inhibitors, particularly in colorectal cancer where they have no role currently?

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Wolfgang Fischer, Affimed N.V. - MD, COO & Member of Management Board [28]

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Sorry, Jim, could you please repeat? I didn't get it. I didn't hear you well, sorry.

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Nicholas M. Abbott, Wells Fargo Securities, LLC, Research Division - Associate Analyst [29]

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How do you think about the activation of adaptive immunity by AFM24, its importance? And then that leads to the possibility of deployment of T cell checkpoint inhibitors, which may be reasonable in lung or head and neck, but they have no role in colorectal cancer, currently.

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Wolfgang Fischer, Affimed N.V. - MD, COO & Member of Management Board [30]

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Yes. So thank you for your question, right, and yes, correct, right? As we think about the innate immunity, right, and we have seen that also in the experiments we have done with AFM13 that once we can activate the innate immunity, right, there is a crosstalk to the adaptive immunity. And to indicate -- or not to indicate, to trigger the adaptive immunity, right, as you mentioned, that opens the space for several combinations, right? For example, checkpoint inhibitors. And we are thinking along the same lines, right?

When it comes to the different indications, right, yes, we have done analysis and looked into the science and the biology of these tumors, right? Where we have checked whether there is a prevalence of NK cells, whether the prevalence of NK cell is associated with beneficial outcome, we have also checked whether these -- in these tumor types, ADCC plays a role, et cetera, and have analyzed and selected the indications accordingly.

However, in the first part of the Phase I, right, we have no limitations regarding the indication because what we allow is patients having tumors where it's known that EGFR is a target value.

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Nicholas M. Abbott, Wells Fargo Securities, LLC, Research Division - Associate Analyst [31]

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Okay. And then just the last one. In going back to the PTCL trial, I think initially, either you guided to having data on 20 patients around about mid-2020. Do you still think that's a feasible goal?

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Adi Hoess, Affimed N.V. - CEO, MD & Member of Management Board [32]

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Well, what we're guiding now is to the second half of 2020. So it may be a little later. We're just in the start-up phases and to make any more concrete projections is a little challenging as it's a rare disease. However, as you've heard in the outline and some of the answers before, we have identified a significant number of sites in so many different countries.

All the start-up activities are all progressing. So I'd say that we have a much clearer idea on when exactly we can show some update on the AFM13 registration directed study is maybe already in the next earnings call end of March.

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Operator [33]

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There are no further questions at this time. You can continue.

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Adi Hoess, Affimed N.V. - CEO, MD & Member of Management Board [34]

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Yes. Thanks a lot. Thanks a lot for all this interest and for taking the time to join us today, and the continuous interest and support of Affimed. We look forward to speaking with you again on the fourth quarter update call. As I just mentioned, that's going to be around the end of March. Thanks a lot, and I wish you all a very nice day. Goodbye.

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Operator [35]

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And that does conclude our conference for today. Thank you for participating. You may all disconnect.