Q2 2024 Affimed NV Earnings Call

September 5, 2024

Speaker Change: Good day, everyone and welcome to Affirmate 2nd quarter 2020 for earnings and corporate update call. At the Sam Albert Dispens on a list and on a mode, to ask a question during the Q&A session, you will need to press star 1, 1 on your telephone. You will down here an automatic message advising your hand is raised.

Speaker Change: As a reminder, today's conference call is being recorded. I would like to introduce your hostlet today's call. I'll explain to you this head of industrialization set, Apement, please go ahead.

Speaker Change: Thank you, Livia and thank you all for joining us today for our second quarter, 2024 update call

Speaker Change: Before we begin, I'd like to remind everyone that we should develop and press release earlier today and that can be found on our Investor Relations section of the website On our website you can also find the presentation we will be using today

Speaker Change: On the call today we have members of our management team including Sean Leeland, our new chief executive officer.

Speaker Change: Andreas Harstrick, Archief Medical Officer, Wolfgang Fischer, Archief Operating Officer, Denise Mueller, Archief Business Officer, and Harry Welton are consulting chief financial officer.

Speaker Change: Our financials today will be presented by our VP of Finance Michael Wolf.

Speaker Change: The team will be available for Q&A after the prepared remarks. Before we start, I would like to remind you that today's presentation contains projections and forward-looking statements regarding future events.

Speaker Change: These statements represent our beliefs and assumptions on the days of this call. Except as required by law, we assume no obligation to update these forward-looking statements publicly, or to update the reasons why actual results

Speaker Change: Cooked there for material from those anticipating the forward-looking statement.

Speaker Change: Even if new information becomes available in the future

Speaker Change: These forward-looking statements are subject to risks and uncertainties, and actual results may differ materially from those expressed or implied in these statements.

Speaker Change: Due to various factors including but not limited to those identified under the section entitled risk factors.

Speaker Change: and our filings with the SEC and those identified under the section entitled Forward-looking statements in the press release that we issued today and filed with the SEC. With that, I'll turn the call over to Sean. Sean?

Sean Leeland: Thank you Alex and good morning everyone. I'm excited to speak with you today as the new CEO of AFMAD. Although I am only a few days into this role, I'm eager to share my initial thoughts with our shareholders and the financial community.

Sean Leeland: My decision to join AFMA to date Adrivin, after thoroughly reviewing AFMA's portfolio of innate selling gauges, I'm impressed with the platform and firmly believe we are on the verge of something transformational.

Sean Leeland: The commercial potential is quite significant, as we have achieved clinical proof of concept across three assets, each with distinct indications.

Speaker Change: This progress is particularly encouraging for the many advanced refractory or relapse patients who have limited options across indications, such as non-small cell lung cancer, Hodgkin lymphoma, and acute myolyd leukemia.

Speaker Change: Importantly, AFI meds diverse clinical portfolio offers valuable strategic options for our business and from my perspective is an envyable position in the biotech world.

Speaker Change: My immediate commitment to you are shareholders is to hit the ground running and to secure funding to support our promising clinical programs. I look forward to engaging with our current shareholders and perspective investors alike.

Speaker Change: I'll be speaking with those already from later with the current Affima data and new investors to share my enthusiasm over the clinical pipeline poids for numerous data readouts in the next 12 to 24 months.

Speaker Change: Although the capital markets have been challenging to buy a text in 2024, I am confident our compelling clinical data differentiates us and will allow us to further extend our runway.

Speaker Change: Additionally, I am energized to thoroughly examine our business development strategy and broaden our relationships with pharma partners.

Speaker Change: Innovation is at the heart of our industry, and I am particularly interested in exploring how creative partoring approaches, headed vans are clinical development, broaden our clinical development strategy to reach more patients faster, and expand patient access to our therapies.

Speaker Change: During the interview process, I was impressed with the Appiement Passionate Employees and Culture, dedicated to developing life-changing therapies to address underserved patient populations. The both survive and thrive we must achieve operational efficiency and excellence.

Speaker Change: While I acknowledge the significant organisational changes at the Appie-Medits undergone over the past year, I am committed to continuous improvement and a growth mindset to ensure we are consistently delivering meaningful value to our key stakeholders.

Speaker Change: Before I turn the call over to Andreas, I want to express my sincere thanks to him and the role he served as acting CEO over the past several quarters. Now over to you Andreas.

Andreas Harstrick: Thank you so much and I'm really happy to have you on board.

Andreas Harstrick: and also good morning to everybody with listening on to our call.

Andreas Harstrick: Let me go through our programs in detail and put some new data in perspective.

Andreas Harstrick: We are happy to report that we, again, have made progress in all programs.

Andreas Harstrick: I will start with our AFM24102 trial in which we evaluate the combination of AFM24 plus adhesive and adhesive mat in patients with non-small cell uncancer who have failed standard of care options.

Andreas Harstrick: Both the EGF are white type and the EGF are mutant non-smonsal and cancer cohorts are almost fully enrolled now.

Andreas Harstrick: Today, we will share with you early efficacy data for the EDF on Mutant Coolheart.

Andreas Harstrick: As you know, the treatment sequence for patients with EGF-Mute and non-Smancer Lancaster starts with the application of an EGF-R specific TKI.

Andreas Harstrick: Most patients today will receive search generation TKI's.

Andreas Harstrick: While these treatments are highly effective in prolonging time to tumor progression, they are not curative for patients with advanced or metastatic disease and ultimately almost all patients will progress.

Andreas Harstrick: Treatment options after failure to EJFR's specific KKI are limited.

Speaker Change: Platinum-based chemotherapy is standard that may in the future be replaced by a combination based on Amirantamap and chemotherapy with always out an asserting it.

Speaker Change: While Amirvantam, upcontaining regimens, have shown some improvement over chemotherapy alone, they are also not curative and all patients with ultimately experienced disease progression.

Speaker Change: If you look at the NCC and guidelines, there are no established treatment alternatives for EDF, our mutant non-smolterline cancer patients who have failed two lines of treatment.

Speaker Change: The options given by NCCN are either palliatives care or single agent chemotherapy.

Speaker Change: which was usually associated with lower response rates and the progression free survival of around four months or the enrollment into a clinical trial.

Speaker Change: This is exactly these patients who currently have no treatment options available that we have enrolled into our study.

Speaker Change: As shown on slide four a total of 24 patients have received treatment so far.

Speaker Change: Seven patients are not available according to a racist, including four patients who deteriorated rapidly, often was in the first week on study.

Speaker Change: These are for the most part patients who had a long interval between the screening evaluation and the actual start of trial medication, and we have to assume that they had rapid tumor progression in the treatment for interval.

Speaker Change: One patient did not have a full-up scan, and two patients are in the first two cycles having no tumor assessment yet.

Speaker Change: On slide five, you can see the patient correct the wrist sticks.

Speaker Change: The major number of previous lines of therapy is 3

Speaker Change: All patients have been treated with EGF Art Targeting TKI's.

Speaker Change: and Zavath Majority Moderns Requators, had also played in a based combination chemotherapy.

Speaker Change: Only two patients had been portrayed as checkpoint inhibitors reflecting the general belief in the medical communities that each of our new non-sponsor lung cancer is not responsive to checkpoint inhibitors.

Speaker Change: On slide 6, we show that in the 17 patients that are a responsibility valuable, we have four patients with an objective response.

Speaker Change: including one patient with complete response and three patients with partial response.

Speaker Change: All confirmed by sequential CT scans.

Speaker Change: and eight patients with stable disease, including patients with reductions in tumor volumes that failed CPR threshold.

Speaker Change: Resulting in an objective response rate of 23.5% and the disease control rate of 70.6%.

Speaker Change: Importantly, the responses appear to be durable and thus clinically meaningful.

Speaker Change: All four responders were on treatment for at least seven months.

Speaker Change: Important to note, eight of 17 patients are still on treatment with a median follow-up for the cohort of over seven months.

Speaker Change: When the state are still early, they indicate, like the data in the EDF-AWI type cohort, which we reported earlier this year, and that's a combination of AFM24 with a checkpoint inhibitor, has activity in treatment refractory, non-small-cel-an-cancer patients.

Speaker Change: and maybe come a meaningful treatment or turnative for patients who failed standard of cat therapies.

Speaker Change: This was why noting that these data achieved was a regimen that does not contain any chemotherapy. An important distinction from other treatments as chemotherapy is often difficult to tolerate by this heavily pre-treated patients.

Speaker Change: and let us now move to our CD 30 target getting

Speaker Change: Ice Amolixule AFM 13 or Simtumic.

Speaker Change: That we are developing in combination with L.O. and K. in our registration directed Luminaise 203 study, in patients with multi-refractory Hodgkin's lymphoma.

Speaker Change: As you see from the study diagram on slide 8, the initial part of the study consists of four cohorts that are designed to optimize the doses of a centimic and aloe and k respectively.

Speaker Change: O'Hotz-1 and 2 are fully enrolled, and all patients have at least one efficacy read out, conducted by an independent response assessment committee.

Speaker Change: As you see on slide, nine old patients were heavily pre-treated, having exhausted all standard treatment options, including combination chemotherapy, brain taxi map, and PD1 targeting checkpoint inhibitors.

Speaker Change: 50% of the patients had also failed stem-set transplant.

soren onslaid: Given that there are no treatment alternatives for these patients, soren onslaid 10

soren onslaid: We observe a response rate of 83.3% which I believe is outstanding.

soren onslaid: This includes six patients or 50% with a complete response and four patients with a partial response.

soren onslaid: It's important to note that three of the four powerful response patients have not completed their full treatment yet and are continuing to receive additional cycles.

soren onslaid: In this contact, it may be important to remember our experience from the MD Anderson trial, where one The red of the complete responses occur at later side of.

soren onslaid: On slide 11, I'm also happy to report that chord 3 and 4 in which we test the higher dose of LNK product are almost completely enrolled with can of its plant 12 patients on treatment.

soren onslaid: Enrollment in chord 3 and 4 progressed according to the plant enrollment schedule and there were no dropouts of patients during screening.

soren onslaid: Furthermore, we have now 10 different sites across the whole USA that have actively treated patients on the study.

soren onslaid: We plan to disclose data from all four cohorts at an upcoming scientific meeting in Q4, 2022-24.

soren onslaid: Finally, let's review the updated results of AFN28, our CD-123 targeting ICE for the treatment of acute mildly chemical, as shown on slide 13.

soren onslaid: In this study, we have escalated dosings through 6 cohorts up to 300mg flat dos weekly.

soren onslaid: The treatment is very well tolerated, with infusual letter reactions, mainly of low grade beings of main side effect.

soren onslaid: At the two highest dose cohorts of 250 and 300 milligrams, we did not observe any dose limiting toxicities.

soren onslaid: And in 12 patients, only three patients had a great two infusion-related reaction, responding in all cases to symptomatic treatment.

soren onslaid: There were no great three or higher IRRs. One patient experienced a short lasting self-limiting cytokine release syndrome of great one.

soren onslaid: Infections are a characteristic manifestation of acute leukemia and was seen in approximately half of patients we treated in the study so far.

soren onslaid: However, no infection was considered to be treatment related by the investigator.

soren onslaid: The clinical activity is displayed on slide 14

soren onslaid: In those level 5 of 250 mg AFM 28, we saw one complete response 17% and 5 stable diseases in heavily pre-treated patients.

soren onslaid: Of note, the patient who was a complete response was in remission for more than five months.

soren onslaid: In those levels 6 at 300mg air from 28

soren onslaid: The number of complete responses has increased compared to the data that we reported in our Q1 earnings call.

soren onslaid: Now, three out of six patients have developed a complete response or a CRI respectively, for a complete response rate of 50% indicating a possible dose response relationship.

soren onslaid: In addition to our three remaining patients at those level six, have shown stable disease.

soren onslaid: These highly encouraging results have led to our decision to expand court six by additional six patients, to confirm the monocerarchy signal that we have seen in the study so far.

soren onslaid: We plan to give a first update on this data at an upcoming scientific conference.

soren onslaid: As we show on slide 15, we believe, first a development of AFM28, in combination with other AML therapies, or with cryopreserved eligenic and k-cells, would allow us to address again an area of significant unmedical need.

soren onslaid: The seven major markets, we see over 14,000 patients per year, will fail at least two lines of standard therapy and require a new treatment option.

soren onslaid: With this, I will close the overview of our clinical programs and hand over to Michael Wolf for a review of the financial data.

soren onslaid: Please.

Michael Wolf: Thank you Andreas.

Michael Wolf: Belensheet and Income Statement Highlights are shown on slides 17-18 of the presentation.

Michael Wolf: Based on our current operating and budget assumptions, we anticipate.

Michael Wolf: Our cash and cash equivalents and investments together with anticipated proceeds from the ATM program and the sale of uptake with <unk>.

Michael Wolf: Finance us into the second half of 2025.

Michael Wolf: Net cash used in operating activities for the quarter ended June 32024 was $16 5 million euros, compared with $33 3 million euros for the quarter ended June 32023.

Michael Wolf: Total revenue for the quarter ended June 32024 was <unk> 2 million euros, compared with $1 4 million euros for the quarter ended June 32023.

Michael Wolf: R&D expense for the quarter ended June 32024.

Michael Wolf: $11 7 million euros compared to $25 3 million euros in 2023.

Michael Wolf: G&A expenses for the quarter ended June 32024.

Michael Wolf: 4 million euros compared to $6 3 million euros for the quarter ended June 32023.

Michael Wolf: Net loss for the quarter ended June 32024 was $15 5 million euros, or one euro and one zero cents per common share.

Michael Wolf: With a net loss of $29 4 million euros, or one euro and 97 euro cents per common share for.

Michael Wolf: For the quarter ended June 32023.

Michael Wolf: Now I'll turn the call back to Sean for final remarks, Sean.

Sean Leeland: Thank you Michael as you listen to Andreas his update on our clinical programs I Hope you share my enthusiasm about the robustness of our science and data as well as the potential of our therapies to address significant unmet medical needs.

Speaker Change: For instance on AFM 24, the data generated to date in both the non small cell lung cancer, Egfr mutant and wild type cohort are encouraging and supports our hypothesis that the combination of AFM in 'twenty four and PD, one targeting May Act synergistically on the <unk> cycle.

It is remarkable that this can be achieved with a chemotherapy free approach and we look forward to sharing additional data this year from the non small cell lung cancer Egfr wild type cohort in Q4 of 2024.

Speaker Change: For our thin to make program the patients enrolled in the Aluminized <unk> III study are critically ill with advanced disease and no remaining approved treatment options are impressive overall response rate of 83% is a strong indicator of the promise of our approach and when considered in the context of approved products. Our data is very <unk>.

Speaker Change: Telling in a much more heavily pretreated patient population.

Speaker Change: I look forward to sharing additional results from this study as soon as we near completion of enrollment in cohort three and four in Q4 of 2024.

Speaker Change: We are encouraged by the AFM 28, mono therapy, there is a clear and strong signal, which is the basis for the expansion of dose cohort <unk> by adding another six patients. We continue to believe there is potential for higher response rates and perhaps greater durability and a combination development approach.

Speaker Change: Relapsed refractory AML is a difficult disease to treat and there is much room for improving response rates given what's seen with currently approved therapies with CR cri rate in the range of 15% to 30%.

Speaker Change: We need more data and durability. The data we are seeing here underpins my enthusiasm for this program.

Speaker Change: Before we open the call to questions I would like to express my sincere gratitude to bolt the management Board and supervisory Board for Entrusting me with this important role.

Speaker Change: Lastly, I want to reaffirm my commitment to you our shareholders I am dedicated to increasing shareholder value through the successful execution of our clinical development programs, achieving milestones for ordering new partnerships and advancing our transformative therapies closer to patients who need them most.

Speaker Change: With that I. Thank you all for your attention and we're happy to take any questions that you may have operator.

Speaker Change: Thank you, ladies and gentlemen to ask a question you will need to press star one on your telephone and wait for your name to be announced to withdraw your question simply press Star One again, please standby, while we compile the Q&A roster.

Speaker Change: No first question coming from the line of Maury Raycroft with Jefferies. Your line is open.

Maury Raycroft: Hi, good morning, all.

Maury Raycroft: I'd say welcome to Sean.

Maury Raycroft: Congrats on the progress and thanks for taking my questions.

Speaker Change: I'll start with one quick one on April 24.

Speaker Change: New Egfr mutant data I was just wondering if you're observing any differences among patients who had prior third gen <unk> versus those who are getting first or second guarantee guys.

Speaker Change: Hey, Maury and John Thanks for the question.

Andreas Harstrick: Andreas do you want to respond to <unk> question.

Andreas Harstrick: Yep.

Andreas Harstrick: So good question Maury.

Andreas Harstrick: We have not seen any differences in fact, when we look at our four responders are three of the four responders have been pretreated with third generation <unk>. So there is obviously no cross resistance or no lower response rate if a patient had tagged searched generation <unk> compared to a first or second generation.

Andreas Harstrick: Hi.

Speaker Change: Got it Okay. That's helpful and then.

Speaker Change: For the illuminate study.

Speaker Change: I'm just wondering if you can remind me what expectations are for the the higher NK cell dose for cohorts three and four and are you seeing any biological efficacy or safety differences between the 200 300, Meg doses for cohorts one or two.

Bob: Yeah. Thanks, Bob.

Andreas Harstrick: Andreas do you want to respond to this question as well.

Andreas Harstrick: Yeah.

Speaker Change: So for us the symptomatic dose 203 hundred milligram.

Speaker Change: So far we have not seen any differences in terms of response rates. So this was equal across the two cohorts.

Speaker Change: In terms of Aussie cohorts, three and four as a reminder, we do use.

Speaker Change: Higher cell dose here.

Speaker Change: This is a cohort so that is currently in an evaluation and enrollment of the early data that we see are very encouraging but I think we just have to wait until the data across all 12.

Speaker Change: <unk> patients have mature mature to which we will be able to disclose in Q4 2024.

Speaker Change: Got it okay and when you do the update in the fourth quarter of this year will you have to go forward doses selected at that point as well.

Speaker Change: Andreas.

Speaker Change: Yes.

Andreas Harstrick: <unk> if you look at the study protocols are out of the four initial cohorts, we will select two cohorts for continuation in stage, one of Hodgkin lymphoma program and as the data mature we believe that we will be able to make a data driven decision here.

Speaker Change: Got it okay. Thanks for taking my questions.

Mark: Thanks Mark.

Speaker Change: Thank you.

Speaker Change: And our next question coming from the line of Dana <unk> with Leerink partners. Your line is open.

Speaker Change: Hi, Thank you for the question welcome Sean to abdomen.

Speaker Change: I Wonder as you step back and look across these three programs.

Speaker Change: If you are.

Dana: A question to Sean and to Andrea how Youre, considering your development strategy I think I noticed a change in ASM 28, whereas the last update.

Speaker Change: The plan was to immediately find a partner to combine with NK cells and now I heard something that was a little bit more ambiguous more broadly thinking about combination partner.

Speaker Change: If you could comment on I guess on 28 and also whether you are considering different approaches for ASM.

Speaker Change: For as you move alright, thank you.

Speaker Change: Yeah. So dana thanks for the question as well as the outcome.

Speaker Change: Maybe I'll start and then turn it over to Andreas.

Speaker Change: As it relates to <unk> I mean, if you think.

Speaker Change: Think back to the last update we provided we didn't have the data that we have in hand today I mean I think.

Speaker Change: Dean.

Andreas Harstrick: Encouraging monotherapy activity with.

Andreas Harstrick: Three out of six patients showing a CR or cri is is quite encouraging I mean, I think it's important to note that in this.

Andreas Harstrick: Relapsed refractory setting and keep in mind most of these patients have seen.

Andreas Harstrick: Three or more prior lines of therapy.

Andreas Harstrick: He has seen a 50%.

Andreas Harstrick: CR Cri rate you know as we are.

Speaker Change: <unk> and dose escalation is quite encouraging one.

Comparable therapies are typically showing.

Speaker Change: Our cri rate.

Speaker Change: And that 15% to 30% range. So I mean, I think you know.

Speaker Change: We're starting to see candidates potential dose response relationship.

Operator: Update Call. At this time, over-disciplines on a listen-only mode. To ask a question during the Q&A session, you will need to press star 1-1 on your telephone. You will down here an automatic message advising your hand is raised.

Speaker Change: Which I think leaves us a bit more encouraged with the monotherapy activity I think as we've seen with.

Speaker Change: And to make the program.

We do think that there is additive to your synergy that exists in particular with with Allo NK cells.

Sarah Milo: As Sarah Milo today's conference call is being recorded, I would like to introduce your host with today's call.

Olivia: I'll ask for the kid's head of industrial relationship at Affimed. Please go ahead.

Speaker Change: So I mean under that context.

Alex: Thank you, Olivia, and thank you all for joining us today for a second quarter 2024 update call. Before we begin, I'd like to remind everyone that we should deliver press release earlier today, and that can be found on our investor-relations section of the website. On our website, you can also find the presentation we will be using today. On the call today, we have members of our management team, including Sean Leland, our new Chief Executive Officer, Andreas Harstrick, our Chief Medical Officer, Wolfgang Fischer, our Chief Operating Officer, Denise Mueller, our Chief Business Officer, and Harry Welten, our Consulting Financial Officer. Our financials today will be presented by our VP of Finance, Michael Wolf. The team will be available for Q&A after the prepared remarks.

Speaker Change: If we add allo NK cell to AFM 28 can we see.

Speaker Change: Deeper and more durable responses I think there's the potential for that but I think first and foremost we're highly encouraged by the monotherapy signal and by adding these additional six patients will be able to get a stronger sense of how encouraging that monotherapy signal is but I'll pause here and CFO Andreas has anything.

Andreas Harstrick: To add.

Andreas Harstrick: Oh, Thank you cover.

Andreas Harstrick: Very well.

Speaker Change: Again these are as always in clinical development data driven decision and I.

Andreas Harstrick: Just.

Andreas Harstrick: I want to emphasize.

Andreas Harstrick: If somebody had told me when we started eight from 20 eights that we will have a 50% complete response rate I would have sat here great I'd take it but these are just outstanding data and I think we have the obligation to find the best way to bring this treatment to patients who can be in combination with ISO standards.

Alex: Before we start, I would like to remind you that today's presentation contains projections and forward-looking statements regarding future events. These statements represent our beliefs and assumptions only as of the date of this call. Except as required by law, we assume no obligation to update these forward-looking statements publicly, or to update the reasons why actual results could differ materially from those anticipated in the forward-looking statements, even if new information becomes available in the future.

Speaker Change: Care drugs that are used in AML. It can be a combination was an NK cell product. So.

Speaker Change: Clearly multiple options and from 2008 has become for us in <unk>.

Speaker Change: Trusting a very promising product. The same is true of <unk> from 24 again non small cell lung cancer.

Speaker Change: Challenging disease.

Alex: These forward-looking statements are subject to risks and uncertainties, and actual results may differ materially from those expressed or implied in these statements, due to various factors, including, but not limited to, those identified under the section and title, risk factors in our filings with the SEC, and those identified under the section and title, forward-looking statements in the press release that we issued today, and filed with the SEC.

Speaker Change: Especially if patients are pretreated with at least two lines of therapy.

Again this is a case for both softwood cohorts.

Speaker Change: <unk> Egfr mutant you don't have any standard of care treatments.

Speaker Change: And to see a consistent efficacy results.

Speaker Change: This is the most important thing that's not just one numbers it pops up but you'll see consistency youll see objective responses in both cohorts, you'll see durable responses in both cohorts.

Alex: With that, I'll turn the call over to Sean. Sean?

Speaker Change: Again, something that we believe is highly encouraging.

Sean: Thank you, Alex, and good morning, everyone. I'm excited to speak with you today as the new CEO of Affymead. Although I am only a few days into this role, I'm eager to share my initial thoughts with our shareholders and the financial community. My decision to join Affymead was data-driven. After thoroughly reviewing Affymead's portfolio of an eight-selling gauges, I am impressed with the platform and firmly believe we are on the verge of something transformational.

Speaker Change: <unk> really change the lives of patients in need.

And we will have to currency best way as an organization to move these programs.

Speaker Change: Forward to bring them to patients.

Speaker Change: Whether this will be best done in a partnership.

Speaker Change: To a certain extent initially alone is enough in that organization.

Speaker Change: We will shift.

We are evaluating all strategic options.

Speaker Change: But the most important thing is that we have data to build on that yes.

Sean: The commercial potential is quite significant as we have achieved clinical proof of concept across three assets, each with distinct indications. This progress is particularly encouraging for the many advanced refractory or relapse patients who have limited options across indications, such as non-small cell lung cancer, Hodgkin lymphoma, and acute myeloid leukemia. Importantly, Affymead's diverse clinical portfolio offers valuable strategic options for our business, and from my perspective is an enviable position in the biotech world.

Speaker Change: That's where we are right now and just can share my enthusiasm about this data.

Speaker Change: It looks really really very promising.

Speaker Change: Maybe one follow up on an AML as their durability of response threshold.

Speaker Change: You guys would like to see to think about.

Speaker Change: A potential single agent path for Orion.

Speaker Change: Yeah. So good question Andreas do you want to respond to the Dana.

Speaker Change: Yes.

Speaker Change: Responses.

Dana: Of course has to be durable to be meaningful for patients.

Sean: My immediate commitment to you, our shareholders, is to hit the ground running and to secure funding to support our promising clinical programs. I look forward to engaging with our current shareholders and prospective investors alike. I will be speaking with those already familiar with the current Affimed data and new investors to share my enthusiasm over the clinical pipeline poise for numerous data readouts in the next 12 to 24 months. Although the capital markets have been challenging to biotech in 2024, I am confident our compelling clinical data differentiates us and will allow us to further extend our runway.

Speaker Change: These are heavily pretreated patients any single agent that produces responses.

Speaker Change: The retro free survivals that assumes a range of six months I think is meaningful.

Especially if this can be achieved was very low toxicity.

Speaker Change: And.

Speaker Change: So this would be I think a threshold for a single agent development, but again given the very good side effect profile in two very unique mechanism of action I think we also have any multiple kinds of options for combination development either with standard of care drugs or as we have mentioned already was allogeneic NK cells.

Sean: Additionally, I am energized to thoroughly examine our business development strategy and broaden our relationships with pharma partners. Innovation is at the heart of our industry and I am particularly interested in exploring how creative partnering approaches can advance our clinical development, broaden our clinical development strategy to reach more patients faster and expand patient access to our therapies. During the interview process, I was impressed with Affimed passionate employees and culture, dedicated to developing life-changing therapies to address underserved patient populations.

Speaker Change: Thank you.

Speaker Change: And our next question coming from the line.

Bill <unk>: Bill <unk> with <unk> Securities. Your line is now open.

Bill <unk>: Hi, Congrats on the progress welcome Sean.

Speaker Change: Our market pick up.

Speaker Change: Follow up question on AML I was wondering if you guys could maybe give us a hint of some of the mutations at some of these AML patients Harbor.

Speaker Change: Because I know the response rates are different in different subsets.

Andreas Harstrick: To both survive and thrive, we must achieve operational efficiency and excellence. While I acknowledge the significant organizational changes Affimed has undergone over the past year, I am committed to continuous improvement in a growth mindset to ensure we are consistently delivering meaningful value to our key stakeholders. Before I turn the call over to Andreas, I want to express my sincere thanks to him and the role he served as acting CEO over the past several quarters. Now, over to you, Andreas. Thank you, Sean, and I am really happy to have you on board. And also good morning to everybody who is listening to our call.

Speaker Change: Regardless your data is very impressive monotherapy, so far but any sort of color on that would be great.

Speaker Change: Hey, Bill Thanks for the welcome.

Speaker Change: Andreas do you want to respond to Bill's question as it relates mutations that we've seen thus far.

Speaker Change: Patients treated with <unk>.

Speaker Change: Yeah. So.

Andreas Harstrick: We are currently at <unk>.

Andreas Harstrick: Binding.

Speaker Change: Compiling and collecting all this data, but what we see so far it's a mixture. So we do not have unusual selection of things is probably quite representative for the mutation patterns that youll see in a pre treated AML population.

Speaker Change: And we will have all of these states are ready for our upcoming data release at a scientific conference in Q4.

Andreas Harstrick: Let me go through our programs in detail and puts in new data in perspective.

Andreas Harstrick: We are happy to report that we, again, have made progress in all programs. I will start with our AFM-24-102 trial, in which we evaluate the combination of AFM-24 plus adhesive lismate in patients with non-small cell lung cancer who have failed standard of care options. Both the EGF are wide type and the EGF are mutant non-small cell lung cancer cohorts are almost fully enrolled now. Today, we will share with you early efficacy data for the EGF am mutant cohort.

Thank you.

Speaker Change: And our next question coming from the line of.

Speaker Change: <unk> with Cantor your line is open.

Speaker Change: Hey, guys. Thanks for taking our questions and Sean wants to.

Speaker Change: At my congrats as well.

Speaker Change: Service for.

Speaker Change: 13 cohort one and two wondering if you can comment on I guess, how many of these 12 patients are still on study.

And what are you seeing in terms of durability.

Speaker Change: And then also curious for the patients that achieved partial response.

Andreas Harstrick: As you know, the treatment sequence for patients with EGF am mutant non-small cell lung cancer starts with the application of an EGFR-specific TKI. Most patients today will receive third-generation TKI's. While these treatments are highly effective in prolonging time-to-tumor progression, they are not curative for patients with advanced or metastatic disease, and ultimately almost all patients will progress. Treatment options after failure to EGF are specific TKI's are limited. Platinum-based chemotherapy is standard, but may in the future be replaced by a combination based on amivantamap and chemotherapy with or without an ascertainment.

Speaker Change: Wondering if you can comment on the kinetics of the response and trends Youre seeing in terms of deepening response.

Anyway, Thanks for the welcome and congrats.

Andreas Harstrick: Andreas do you want to follow up on her questions.

Andreas Harstrick: Yes, so yes.

Andreas Harstrick: I think for duration of response or general duration question as a follow up is just too short.

Speaker Change: You know, we initially had to stagger enrollment.

Speaker Change: Obviously, the two patients with progressive disease, who did not respond have lots to study, but the majority of patients still on treatment.

Speaker Change: Oh I missed two set for example, three of the four patients was a PR are still on treatment.

Andreas Harstrick: Well, I'm event I'm up containing regimens have shown some improvement over chemotherapy alone. They are also not curative, and all patients will ultimately experience disease progression. If you look at the NCCN guidelines, there are no established treatment alternatives for EGFR mutant non-smotser lung cancer patients who have failed two lines of treatment. The options given by NCCN are either palliative care or single-agent chemotherapy, which is usually associated with low response rates and the progression free survival of around four months, or the enrollment into a clinical trial.

Speaker Change: The complete responses that we have reported the six complete response was they were all complete response after the first cycle.

So there is obviously a technically no way to see a further kinetics.

Speaker Change: But when we referred or when we take into account.

Speaker Change: Once that we had at MD Anderson, roughly one third of the patients that ultimately.

Speaker Change: <unk> a complete response were partial responders after cycle, one and then with additional cycles got into a complete response.

Speaker Change: So we will have to wait until we have completed treatment of additional patients to be able to really comment on the on the response kinetics against the six patients that we're reporting right. Now is complete response or were complete responders after the first cycle.

Andreas Harstrick: It is exactly these patients who currently have no treatment options available that we have enrolled into our study. As shown on slide four, a total of 24 patients have received treatment so far. Seven patients are not available according to resist, including four patients who deteriorated rapidly, often was in the first week on study. These are for the most part patients who had a long interval between the screening evaluation and the actual start of trial medication, and we have to assume that they had rapid tumor progression in the treatment for interval.

Speaker Change: Okay great.

And I have a follow up question in terms of <unk>.

Speaker Change: Screening failure rate.

Speaker Change: I Wonder if you can just comment on what Youre seeing now it seems like you made pretty nice enrollment progress for cohorts three and four.

Speaker Change: Was that more driven by maybe more site Orient nisha data or maybe a combination of factors.

Speaker Change: And is this sort of a good run rate of enrollment.

Speaker Change: That we should be thinking about as you move into that.

Andreas Harstrick: One patient did not have a fall-up scan, and two patients are in the first two cycles having no tumor assessment yet. On slide five, you can see the patient's characteristics. The median number of previous lines of therapy is three. All patients have been pre-treated with EGFR targeting TKI's and so vast majority, modern three quarters, had also platinum-based combination chemotherapy. Only two patients had been pre-treated with checkpoint inhibitors, reflecting the general belief in the medical community that EGFR mutant non-small cell lung cancer is not responsive to checkpoint inhibitors.

Speaker Change: Randomized portion.

Speaker Change: Yes.

Speaker Change: Is that we are really happy was enrollment in cohort three and four.

Speaker Change: But this is something that you often see in trials that initially you'll have to do some training of the sites.

Speaker Change: And then we also had a couple of patients who just dropped out because of infectious complications.

Speaker Change: No I think sites have see right feeling for the right patients. We also have more sites I am very encouraged by the enrollment.

You know whenever you move from a single site study, especially if it's academic centers like MD Anderson. So always some concerns whether you can reproduce this in a real world setting if you will but now with 10 sites actively enrolling patients and still producing these outstanding data I think.

Andreas Harstrick: On slide six, we show that in the 17 patients that are responsive valuable, we have four patients with an objective response, including one patient with complete response and three patients with partial response. All confirmed by sequential CT scans, and eight patients with stable disease, including patients with reductions in tumor volumes that failed the PR threshold. Resulting in an objective response rate of 23.5%, and a disease control rate of 70.6%. Importantly, the responses appear to be durable and thus clinically meaningful.

Speaker Change: It's indicating that this is a treatment that can really be given across the country and can reach many patients in need because basically every site.

Site that has some experience with lymphoma treatment can can administer this type of treatment.

Speaker Change: Thank you and our next question coming from the line of.

Allison <unk>: Allison <unk> with Wells Fargo Securities. Your line is now open.

Andreas Harstrick: All four responders were on treatment for at least seven months. Important to note, eight of 17 patients are still on treatment with a median follow-up for the cohort of over seven months. While these data are still early, they indicate, like the data in the EGFR white type cohort which we reported earlier this year, and that's a combination of AFM24 with a checkpoint inhibitor, has activity in treatment refractory non-small cell lung cancer patients, and may become a meaningful treatment alternative for patients who failed standard of care therapies. This was why noting that this data achieved with a regimen that does not contain any chemotherapy, an important distinction from other treatments as chemotherapy is often difficult to tolerate by these heavily pre-treated patients.

Allison Kwan: Hi, Thanks for taking no question and congrats John and this is kwan for.

Allison: <unk>. So my question is I think to make you mentioned that there.

Speaker Change #101: The response rate.

Speaker Change #103: Consistent across cohorts, one and two I wonder if there is a dose response.

Speaker Change #104: Alright, thank you.

Speaker Change #104: Thanks for the welcome and congrats Andreas do you want to speak to that.

Andreas Harstrick: The potential dose response with the symptomatic.

Andreas Harstrick: As we already said currently we have not seen a difference in response between cohorts one and two so no difference in 200 plus 300.

Andreas Harstrick: Milligrams are symptomatic or we also have not seen any difference in toxicity.

Again with longer follow up we will have to evaluate whereas there is a difference in terms of duration of responses.

Andreas Harstrick: Let us now move to our CD-30 targeting ice amolecule, AFM-13, or Symptomic, that we are developing in combination with ALO and K, in our registration directed Luminize 203 study, in patients with multi-refractory Hodgkin's lymphoma. As you see from the study diagram on slide 8, the initial part of the study consists of four cohorts that are designed to optimize the doses of Symptomic and ALO and K respectively, cohorts 1 and 2 are fully enrolled and all patients have at least one efficacy readout conducted by an independent response assessment committee.

Speaker Change #105: Now with courts reinforced we ask the second important question, which is I was there a higher dose of allo.

Speaker Change #106: Hello, NK cell will make a difference.

Speaker Change #106: But here, we have to wait until the data a little bit mature but.

Speaker Change #106: And then in terms of response rates are no difference between 203 hundred milligrams.

Speaker Change #107: Got it and that includes the C outright right.

Speaker Change #107: Yes.

Speaker Change #108: Okay, great. Thank you.

Speaker Change #108: <unk> 20.

Speaker Change #109: 24 can you remind us the bar.

Speaker Change #110: PFS and any updated data on PFS, you can share with us.

Speaker Change #111: So well tie in Milton Thank you.

Speaker Change #111: Yeah, Andreas do you on the spot.

Andreas Harstrick: As you see on slide 9, all patients were heavily pre-treated, having exhausted all standard treatment options including combination chemotherapy, rentaxi-map, and PD-1 targeting checkpoint inhibitors. 50% of the patients had also failed stem-set transplant. Given that there are no treatment alternatives for these patients, so on slide 10, we observe a response rate of 83.3%, which I believe is outstanding. This includes six patients or 50% with a complete response and four patients with a partial response.

Speaker Change #111: Yeah.

Andreas Harstrick: Yeah. So.

Andreas Harstrick: Again for the.

Speaker Change #112: Why it's type we have the data that we disclosed at our last earnings call was the PFS was five nine months.

Speaker Change #113: We have not an updated PFS for the additionally enrolled patients.

Speaker Change #113: Something that probably will be available Q1, 2025, we will have response data for <unk>.

Speaker Change #113: Expanded egfr wild type cohort in Q4 of this year.

Speaker Change #113: As we reported for the Egfr mutant cohorts today, we still have roughly 50% of <unk> patients.

That our response Evaluable on treatment with a median follow up of seven months.

Andreas Harstrick: It's important to note that three of the four partial response patients have not completed their full treatment yet and are continuing to receive additional cycles. In this contact, it may be important to remember our experience from the MD Anderson trial, where one third of the complete responses occurred at later cycles. On slide 11, I'm also happy to report that cohorts 3 and 4, in which we test the higher dose of ALO and K product, are almost completely enrolled, with 10 of these planned 12 patients on treatment.

Speaker Change #113: What we don't have mature PFS yet.

Speaker Change #113: Against these responses that we see on justice.

Speaker Change #114: Exactly the same was the Egfr wild type Egfr mutant cohorts they seem to be durable as we set off for <unk>.

Speaker Change #114: It's been on treatment for at least seven months.

Speaker Change #114: When we reported the Egfr Wild type cohort again Z responses were lasting 789 months and still some of these patients who are undergoing at eight to nine months.

Speaker Change #115: But we will need for both corn, so a little bit more mature ration of data to have a final PFS number.

Andreas Harstrick: Enrollment in cohorts 3 and 4 progressed according to the planned enrollment schedule, and there were no dropouts of patients during screening. Furthermore, we have now 10 different sites across the whole USA that have actively treated patients on the study.

Speaker Change #115: As a reference again.

Speaker Change #115: Single agent chemotherapy.

Speaker Change #115: Or even the chemotherapy in combination with <unk>.

Speaker Change #115: VEGF inhibiting agent like <unk>.

Speaker Change #115: Usually produces PFS data.

Andreas Harstrick: We plan to disclose data from all four cohorts at an upcoming scientific meeting in Q4, 2020-24.

Speaker Change #115: Four or four five months so.

Speaker Change #115: Roughly half of the patients are still on trial at seven months is for us highly encouraging as.

Andreas Harstrick: Finally, let's review the updated results of AFM-28, our CD-123 targeting ICE for the treatment of acute myelot leukemia, as shown on slide 13. In this study, we have escalated dosings through six cohorts up to 300 milligrams flat dose weekly. The treatment is very well tolerated, with infusural-ledged reactions mainly of low grade being the main side effect. At the two highest dose cohorts of 250 and 300 milligrams, we did not observe any dose-limiting toxicities.

Speaker Change #115: <unk> data in Egfr Wild type quarter, where we have close to six months of PFS.

Speaker Change #116: Got it that's super helpful. Thank you.

Speaker Change #117: Thank you.

Speaker Change #117: And our next question coming from the line of Rob.

Speaker Change #118: <unk> with Stifel. Your line is now open.

Rob: Hi, and thank you Sean nice to hear you on the call and you have a question for you I think when I look at your past history. A majority of your experience has been the development of drugs with distinct monotherapy activity and here you've got <unk> 20 for the activity signal derived from single arm data uncontrolled and <unk>.

Andreas Harstrick: And in 12 patients, only three patients had a grade two infusural-ledged reaction, responding in all cases to symptomatic treatment. There were no grade three or higher IRRs, one patient experienced a short-lasting, self-limiting cytokine-release syndrome of grade one. Infections are a characteristic manifestation of acute leukemia, and were seen in approximately half of patients we treated in the study so far. However, no infection was considered to be treated related by the investigator.

Speaker Change #120: Combination with a drug that is known to have some limited salvage activity. So it would be great. If you can walk me through your diligence process and how you've added the potential contribution of the parts or perhaps the right word is synergy from <unk> 24.

Rob: Yeah.

Rob: Thanks, Brad and great to hear from you.

Speaker Change #121: I think overall looking across kind of the net portfolio of <unk> products I mean I think.

Speaker Change #121: What is quite encouraging is the fact that there is.

Speaker Change #122: Great validation of the platform technology across not only solid tumors in terms of what we've seen with <unk> 24 in combination with anti PD, one but also in the hematologic malignancy space as it relates to what we've seen with attempt to Meg.

Andreas Harstrick: The clinical activity is displayed on slide 14. In dose level five of 250 milligrams AFM 28, we saw one complete response, 17%, and five stable diseases in heavily pre-treated patients. Of note, the patient with a complete response was in remission for more than five months. In dose level six at 300 milligrams AFM 28, the number of complete responses has increased compared to the data that we reported in our Q1 earnings score.

Speaker Change #122: And then also with what.

Well, we've recently been seeing with with the AFM 28, I mean, I think that there is.

Speaker Change #122: Clear signs that there's there's monotherapy activity that's been seen with these products, but I also believe that there is perhaps greater potential with the combinations.

Speaker Change #122: So that is really kind of what we're seeing.

Andreas Harstrick: Now, three out of six patients have developed a complete response or a CRI respectively. For a complete response rate of 50%, indicating a possible dose response relationship. In addition, two of three remaining patients at dose level six have shown stable disease. These highly encouraging results have led to our decision to expand courts six by additional six patients to confirm the monotherapy signal that we have seen in the study so far.

Speaker Change #123: <unk> seen in my due diligence I think.

Speaker Change #123: A lot of <unk>.

Speaker Change #123: My due diligence was also looking at where this data stacks up.

Speaker Change #123: Against competitors, Brad and I mean kind of taking them kind of like one step at a time here and I mean, you look at the <unk> program.

Speaker Change #124: Uh huh.

Speaker Change #123: 83%.

Speaker Change #123: In a response rate with a 50% CRE and.

Speaker Change #123: And what is arguably a much more heavily pretreated population than what than the.

Andreas Harstrick: We plan to give a first update on this data at an upcoming scientific conference. As we show on slide 15, we believe further development of AFM 28 in combination with other AML therapies or with CRIO-preserved Eligenic and K cells would allow us to address again an area of significant unmet medical need. The seven major markets we see over 14,000 patients per year who fail at least two lines of standard therapy and require new treatment option.

Speaker Change #123: Etc label for example, and then also what's in either the Opdivo, our NIM all the mab labels.

This is highly encouraging I mean this is something that you know from my perspective could be.

Speaker Change #123: Our best our best option for.

Speaker Change #123: Patients with Hodgkin's lymphoma, and I mean, this is a very heavily pretreated patient population. So I would also look at this from the perspective of.

Speaker Change #123: Being able to address unmet medical needs and yes, historically focused in kind of the precision oncology mono therapy space.

Michael Wolf: With this, I will close the overview of our clinical programs and have hand over to Michael Wolfe for a review of the financial data. Michael, please. Thank you, Andreas. Balance sheet and income statement highlights are shown on slides 17 and 18 of the presentation. A quick reminder that us means 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 prepared in euros.

Speaker Change #123: But I think more and more as we see.

Speaker Change #123: The field of oncology move you know a lot of that movement is towards that of combinations.

With the AFM.

For I mean, I think as Andreas has highlighted.

Speaker Change #123: There's not really any great options for these patients.

Andreas Harstrick: And in settings, where we are studying them I mean typically.

Andreas Harstrick: You do not see.

Andreas Harstrick: For the Egfr mutated cohort, which is what we kind of focused on.

Andreas Harstrick: As it relates to the update today.

I mean, there's not really anything out there.

Michael Wolf: Since our financials are described in details in the press release, we issued this morning. I will only provide highlights on this call. We ended the second quarter with cash-cash-equivalent and investments of 34.4 million euros compared with 72 million euros on December 31, 2023. Based on our current operating and budget assumptions, we anticipate that our cash-cash-equivalent and investments together with anticipated proceeds from the ATM program and the sale of the object will finance us into the second half of 2025.

Andreas Harstrick: <unk> patients.

Andreas Harstrick: I mean, you're basically talking in a single agent in a kingdom chemotherapy are going onto a clinical trial, which is kind of the NCC and recommendations in a post egfr <unk> and <unk>.

Andreas Harstrick: First products like Amazon that Nab and lizard NIM.

Andreas Harstrick: So I mean, I think the data is highly encouraging and its also quite encouraging since we typically don't see any monotherapy activity of anti PD. One in this population this idea of <unk>.

Andreas Harstrick: Being able to combine.

Andreas Harstrick: <unk> therapy is one that targets.

Michael Wolf: Net cash used in operating activities for the quarter in the 2.30, 2024 was 16.5 million euros compared with 33.3 million euros for the quarter in the 2.30, 2023. Total revenue for the quarter in the 2.30, 2024 was 0.2 million euros compared with 1.4 million euros for the quarter in the 2.30, 2023. R&D expenses for the quarter in the 2.30, 2024 were 11.7 million euros compared to 25.3 million euros in 2023. GNA expenses for the quarter in the 2.30, 2024 were 4 million euros compared to 6.3 million euros for the quarter in the 2.30, 2023.

Andreas Harstrick: <unk> immune system, and one that targets the adaptive immune system and there seems to be a synergistic effect and there seems to be a really nice benefit in these patients who really have no other therapeutic options.

Andreas Harstrick: I appreciate all the commentary around that thank you.

Andreas Harstrick: Mhm.

Andreas Harstrick: Thank you.

Andreas Harstrick: And our next question coming from the line.

Andreas Harstrick: Nicola Rodman <unk> with HC Wainwright your line is open.

Sarah Cannon: Thank you Sarah Cannon from hits your Android.

Sean.

Nicola Rodman: Most of my questions have been answered.

Nicola Rodman: However.

Nicola Rodman: Quick question on the.

Speaker Change #127: Yes, I'm trying to core program.

Speaker Change #128: Now that we have data from both.

Michael Wolf: Net loss for the quarter in the 2.30, 2024 was 15.5 million euros or 1.0 and 1.0 percent per common share compared with the net loss of 29.4 million euros or 1.0 and 97.0 percent per common share for the quarter in the 2.30, 2023.

Speaker Change #128: The mutant.

Speaker Change #128: Easier for.

Speaker Change #128: Patient cohorts.

Speaker Change #129: How do you plan to take this.

Speaker Change #128: Today's forward.

Speaker Change #128: And is there.

Speaker Change #128: <unk> plant.

Speaker Change #128: And these cohorts initially.

Speaker Change #128: To strengthen the data before.

Sean: Now, I'll turn the call back to Sean for final remarks. Sean? Thank you, Michael.

Speaker Change #128: The next level.

Speaker Change #128: Clinical development.

Speaker Change #128: That settlement.

Speaker Change #128: So Ryan thanks for the <unk>.

Sean: As you listen to Andreus's update on our clinical programs, I hope you share my enthusiasm about the robustness of our science and data, as well as the potential of our therapies to address significant unmet medical needs. For instance, on AFM-24, the data generated to date and both the non-small-so-long cancer EGFR mutant and wild-type cohorts are encouraging and supports our hypothesis that the combination of AFM-24 and PD-1 targeting may act synergistically on the immunity cycle. It is remarkable that this can be achieved with a chemotherapy-free approach, and we look forward to sharing additional data this year from the non-small-so-long cancer EGFR wild-type cohort in Q4 of 2024.

Speaker Change #130: And as well as for the welcome.

Speaker Change #130: Andreas do you want to speak to his question.

Speaker Change #131: We also.

Andreas Harstrick: Thanks to this decision <unk> very good question are or will be data driven what we have done, especially for these are wild type we have already expanded as you know we initially reported 17 patients.

Speaker Change #132: We have now a cohort that is basically fully enrolled was a target patient population of 40 evaluable patients. So this will give us a significantly broader dataset.

Speaker Change #132: We expect to have response data by year end and then PFS data.

Speaker Change #132: 2025, and then we will have to make strategic decisions. How to proceed again was the PFS that we are currently seeing also with the <unk>.

Sean: For our centimic program, the patients enrolled in the Luminized 203 study are critically ill with advanced disease in no remaining approved treatment options. Our impressive overall response rate of 83 percent is a strong indicator of the promise of our approach, and when considered in the context of approved products, our data is very compelling and a much more heavily pretreated patient population. I look forward to sharing additional results from the study soon as we near completion of enrollment in cohorts 3 and 4 in Q4 of 2024.

Speaker Change #132: <unk> was the duration of responses, we believe that we could beat standard of care in this area.

Speaker Change #133: <unk> sale, plus minus register them up.

Speaker Change #133: Egypt mutant us even more.

Speaker Change #134: I would say deserted field once patients do not respond to any more to <unk> and platinum based chemotherapy, even palliative care is considered so based.

Speaker Change #134: Based on the data and then.

Speaker Change #135: These data are mature a little bit more we will have all these discussions. We're also start interactions with was the regulatory agencies and really for Malta best way too.

Sean: We are encouraged by the AFM-28 monotherapy. There is a clear and strong signal, which is the basis for the expansion of dose cohort 6 by adding another six patients We continue to believe there is potential for higher response rates and perhaps greater durability in a combination development approach. Relapse refractory AML is a difficult disease to treat, and there is much room for improving response rates given what's seen with currently approved therapies with CR-CRI rates in the range of 15 to 30%. While we need more data and durability, the data we are seeing here underpins my enthusiasm for this program.

Speaker Change #135: Two potential market approval.

Speaker Change #135: Thanks, Andrea Thank you very much for taking my question.

Speaker Change #136: Thank you.

Speaker Change #137: I am showing no further questions in the queue at this time and ladies and gentlemen that does conclude our conference for today. Thank you all for participating and you may now disconnect.

Thank you.

Speaker Change #137: Okay.