Full Year 2023 Affimed NV Earnings Call

Okay.

Operator: Good day, everyone, and welcome to Affimed's fourth quarter and four-year 2023 earnings and corporate update call. At this time, all participants are in a listen-only mode.

None: Good day, everyone and welcome to the Applegate fourth quarter and full year 2023 earnings and corporate update call.

None: At this time all participants are in a listen only mode.

Operator: As a reminder, today's conference is being recorded. After the speaker's presentation, there will be a question and answer session. To ask a question during this session, you will need to press star 11 on your telephone. You will then hear an automated message advising that your hand is raised.

None: As a reminder, today's conference is being recorded.

None: After the speaker's presentation, there will be a question and answer session.

None: Ask the question during the session you will need to press star one on your telephone.

None: Then your automated message advising your hand is right.

Operator: To withdraw your questions, please press star 11 again. I would now like to hand the conference over to Alexander Fudukidis, Head of Investor Relations at Apple. Please go ahead, sir.

None: To withdraw your question. Please press star one again.

None: I'd now like to hand, the conference over to Alexandra Pirquitas head of Investor Relations at <unk>.

Alexander Fudukidis: Thank you, Towanda, and thank you all for joining us today for a quarterly update call. Before we begin, I'd like to remind everyone that we issued the relevant press release earlier today, which can be found in the Investor Relations section of our website. On the call today, we have our management team, including Andreas Harstrick, our Chief Medical Officer and Interim Acting Chief Executive Officer, Wolfgang Fischer, our Chief Operating Officer, Denise Mueller, our Chief Business Officer, and also on the call today, we have Michael Wolff, our VP of Finance, and Harry Welton, our Consulting Chief Financial Officer, to review the financials with us today.

Alexandra Pirquitas: Please go ahead Sir.

Alexandra Pirquitas: Thank you to Wanda and thank you all for joining us today for a quarterly update call before we begin I'd like to remind everyone that we issued the relevant press release earlier today, which can be found in the Investor Relations section of our website on.

Alexandra Pirquitas: On the call today, we have our management team, including undress harsh strike, our chief Medical officer and interim acting.

Alexandra Pirquitas: Chief Executive Officer, Wolfgang Fischer, Chief operating Officer, Denise Mueller, Chief Business Officer, and also on the call today, we have Michael Wolf.

Alexandra Pirquitas: BPL finance and Harry well now consulting Chief Financial Officer to review the financials with us today.

Alexander Fudukidis: 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. 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 reasons why actual results could differ materially from those anticipated in the forward-looking statement, 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 statements due to various factors, including, but not limited to, those identified under the section entitled Risk Factors in our Filings with the SEC and those identified under the section entitled Forward-Looking Statements in the Press Release that we issued today and filed with the SEC. With that, I'll turn the call over to Andreas. Andreas?

Alexandra Pirquitas: The L.

Alexandra Pirquitas: Now here for Q&A after the prepared remarks.

Alexandra Pirquitas: Before we start I would like to remind you 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.

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.

Alexandra Pirquitas: These forward looking statements are subject to risks and uncertainties and actual results may differ materially from those expressed or implied in the 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 <unk>.

Alexandra Pirquitas: Then to fight 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 Andreas Andreas.

Andreas Harstrick: Thank you, Alex, and good day, everyone, and thank you for joining us today for our Q4 quarterly and full year 2023 earnings call. In 2023, despite challenges in the broader biotech industry, Affimed not only achieved meaningful milestones that underscore our resilience and commitment to Advancing Our Innovative Therapies. But more importantly, we laid the groundwork for significant advances across our three clinical assets, AFM24, the symptomatic, and AFM28, in 2024 and beyond. For AFM24, we saw clinical activity in combination with a t-Solesil map across all tested cohorts, with the most notable efficacy in non-small cell lung cancer. This data validated the concept of crosstalk between the adaptive and the innate immune system as suggested by our translational research data from the AFM24 monotherapy study and led to the refinement and focus of our clinical development.

Andreas: Yeah. Thank you Alex and good day, everyone and thank you for joining us today for our Q4 quarterly and full year 2023 earnings call.

Andreas: In 2023, despite challenges in the broader biotech industry.

Andreas: A few of them out not only achieved meaningful milestones that underscore our resilience and commitment to advancing our innovative therapies.

Andreas: But more importantly, we laid the ground work for significant advances across our three clinical assets from 24 are symptomatic at air from 28 in 2024 and beyond.

Andreas: For F. 'twenty four we saw clinical activity in combination with T. Felicia.

Andreas: Across all tested cohorts.

Andreas: It was the most notable of efficacy in non small cell lung cancer.

Andreas: This data validates the concept of a cross talk between the adaptive and innate immune system.

Andreas: As suggested by our translational research data problems the AFM twenty-four monotherapy study.

Andreas: And let's suppose a refinement and focus of our clinical development plan.

Andreas Harstrick: Going forward, we will have a heavy focus on non-small cell lung cancer, with the ambition to address unmet medical need in patients for whom the standard of care, including platinum-based chemotherapy and PD-1 targeting therapy, has failed. For a symptomatic... We reached a significant milestone with the initiation of the LUMINIZE 203 study. Notably, the study design based on FDA feedback and guidelines, coupled with the FASTAC designation, reflect our commitment to expeditiously bring this therapy to patients in need. Furthermore, we made progress with the AFM28 dose escalation study, with recruitment underway in the sixth and final dose cohort. We are making steady strides towards advancing the potential of AFM28 as a therapeutic option for patients with refractory AML. Looking ahead, our primary objective is to drive the momentum of our clinical program and achieve critical data milestones. To this end, we conducted a comprehensive strategic review of our operations, financial outlook, and market conditions. In response, we implemented a significant restructuring initiative in January to focus our attention and resources on the advancement of the clinical program, which we believe has the potential to significantly increase in value as it progresses. We reduced our workforce by approximately 50 percent.

Andreas: Going forward, we will have a heavy focus on non small cell lung cancer.

Andreas: What's the ambition to address unmet medical need in patients for whom standard of care, including platinum based chemotherapy.

Andreas: And PD, one targeting therapy has failed.

Andreas: For symptomatic, we reached a significant milestone was the initiation of the lumi nice two or three study.

Andreas: Notably the study design based on FDA feedback of guidelines, coupled with the fast track designation reflect our commitment to expedite just sleep brings this therapy to patients in need.

Andreas: Furthermore, we made progress with our yeah from 28 to dose escalation study.

Andreas: With recruitment underway in the sixth and final dose cohort.

Andreas: We're making steady strides towards advancing see potential off from 28 as a therapeutic option for patients with refractory AML.

Andreas: Looking ahead, our primary objective is to drive the momentum of our clinical programs and achieved critical data milestones.

Andreas: Towards this end, we conducted a comprehensive strategic review of our operations and financial outlook and market conditions.

Andreas: In response, we implemented a significant restructuring.

Andreas: Initiative in January.

Andreas: To focus our attention and resources on <unk>.

Andreas: Management of the clinical programs.

Andreas: Which we believe has the potential to significantly increase in value as they progress.

Andreas: We reduced our workforce by approximately 50% and focus the organization on clinical development Clint.

Andreas Harstrick: Focus your organization on clinical development, clinical and regulatory operations, and translational research. Importantly, we have also kept key competences in relation to NK cell biology and ICE manufacturing. Now, let me give you a quick update on where we stand with our different programs. I will start with AFM24, as we are very excited about the progress that we have made. As we show on slide 5.

Andreas: Clinical and regulatory operations and translational research.

Andreas: Importantly, we also kept key competences.

Andreas: <unk> to learn NK cell biology.

Andreas: And I see your manufacturing in house.

None: Now let me give you a quick update on where we stand with our different programs.

None: I will start with I guess on 24. So we are very excited about the progress that we have made.

None: As we show on slide five.

Andreas Harstrick: We announced earlier this year that we refined our focus to target patients with EGFR-Y type and EGFR mutant non-small cell lung cancer. We added the EGFR mutant cohort to our combination trial with the T-Soliza map. After seeing promising results with AFM-24 monotherapy in this indication, we believe that the combination of AFM24 with atezolizumab has the potential to demonstrate a meaningful clinical benefit with a favorable safety profile in treatment-refractory non-small cell lung cancer patients, as shown on slide 6 in January's update report. We highlighted the progress in the EGFR-Y type non-small cell lung cancer cohort, where we observed a disease control rate of 73%, including 47% of patients with tumor shrinkage and four objective responses in 15 patients.

None: We announced earlier this year, we have refined our focus to target patients with Egfr Wild type Egfr.

None: UGI for mutant non small cell lung cancer.

None: We edits Egfr mutant cohort.

None: This trial was a T. So lease them up.

After seeing promising results with I S. M 24 mono therapy in this indication.

We believe such a combination of air from 24. It was her tears relieves them up has the potential to demonstrate a meaningful clinical benefit with a favorable safety profile and treatment refractory non small cell lung cancer patients.

None: As shown on slide six in January as update report.

None: We highlighted a progressing the egfr wild type non small cell lung cancer cohort.

None: Wherever you observed a disease control wrote off a 73%.

None: Including 47% of patients with tumor shrinkage and four objective responses in 15 patients.

Andreas Harstrick: The responses included one confirmed complete response and three confirmed partial responses. Of special importance is the fact that three of the four responding patients had never achieved an objective response to previous PD-1 targeting therapy and that the only patient with a previous response to PD-1 responded to a combination of PD-1 and doublet chemo syrup, therefore, even in this patient, making the contribution of PD-1 unclear.

None: So responses, including one confirmed complete response and three confirmed partial responses.

None: Especially importance is the fact that three of the four responding patients had never achieved an objective response to a previous PD one targeting therapy.

None: And that's the only patient was a previous response to PD one.

None: I responded to a combination of PD one into doublet chemotherapy.

None: Therefore, even if this peking patient to make them as a contribution of PD one unclear.

Andreas Harstrick: Even more remarkable is the fact that all four responding patients had progressive disease while still on previous PD-1 treatment regimens. We are now following these patients to generate mature PFS data. The median follow-up for this initial cohort is now six months, and we will be able to report final PSS data around Q2 2024. Based on this promising initial data from the EGFR-WILD type non-small cell lung cancer cohort, we have extended recruitment and will include up to 40 patients in this cohort. We also made progress in advancing the cohort for EGFR mutant non-small cell lung cancer patients.

None: Even more remarkable is the fact that all four responding patients had progressive disease, while still on previous PD one treatment regimens.

None: We are now following these patients to generate mature PFS data.

None: So the median follow up for this initial cohort is now six months and we will be able to report final P. S. S data around Q2 2024.

None: Based on this promising initial data from the Egfr wild type non small cell lung cancer cohort, we have extended recruitment and will include up to 40 patients in this cohort.

None: We also made progress in advancing the cohort for Egfr mutant non small cell lung cancer patient.

Andreas Harstrick: The target is to enroll 25 patients in this cohort, and enrollment is well underway. We are very excited by the promising prospects of the AFM24 trials, recognizing the profound impact a successful outcome could have on addressing a critical unmet need. As we show on slide 7, the standard of care for patients with platinum and PD-1 refractory disease is usually chemotherapy resulting in an average progression-free survival time of around 4.5 months.

None: The target is to enroll 25 patients in this cohort and enrollment is well underway.

None: We are very excited by the promising prospects I'll see a year from 24 trials.

None: Recognizing the profound impact of successful outcome could have at addressing a critical unmet need.

None: As we show on slide seven for standard of care for patients with platinum and PD, one refractory disease is.

None: Usually chemotherapy, resulting in an average progression free survival time of around four five months.

Andreas Harstrick: Importantly, single-agent PD-1 therapy, even in PD-1 naive patients that are platinum resistant, has shown a progression-free survival of only around 2.5 years. Moving now to our hematological assets, starting with symptomatic patients and our Luminize 203, as shown on slide 9. Following FDA clearance to proceed with a Phase II study, which we discussed on our last call, recruitment in this study is proceeding. However, initial recruitment in cohorts 1 and 2 was slightly slower than anticipated. This was caused solely by the mandatory staggering of enrollment for the first three patients per cohort and the dropout of some patients during the screening period.

None: Importantly single agent PD, one therapy, even in PD, one naive patients that are platinum resistant has shown a progression free survival of only around two five months.

None: Okay.

None: Moving now to our Hematological assets, starting with Sim to make and our Lumi Nice 203 study.

None: As shown on slide nine.

None: Following FDA clearance to proceed with a phase two study, which we discussed on our last call.

None: Throughput in this study is proceeding.

None: Initially recruitment in cohorts, one and two.

None: Was slightly slower than anticipated.

None: So this west coast solidly by the mandatory staggering of enrollment for the first three patients per cohort.

None: I had to drop out of some patients during the screening period.

Andreas Harstrick: As we are now beyond the period of staggered enrollment for Courts I and II, we see steady progress and expect to initiate recruitments into Courts 3 and 4 in the next couple of weeks. On the positive side, we see that patient availability for Perside appears to be higher than initially expected, reflecting the commitment of our investigators and the dire need of patients for innovative treatment. On the same slide, we show that LUMINIZE-203 includes an exploratory arm for relapsed refractory peripheral T-cell lymphoma patients.

None: S. We are now beyond the period of stagger enrollment for cohorts, one and two.

None: We see steady progress and expect to initiate recruitment into cohort three and for the next couple of weeks.

None: On the positive side, we see is that patient availability.

None: Her side appears to be higher than initially expected.

None: Reflecting the commitment of our investigators and its a dire need of patients for elective treatments.

None: On the same slide we show that let me nice to a suite includes an exploratory arm for relapsed refractory peripheral T cell lymphoma patients.

Andreas Harstrick: PTCL represents a high unmet medical need, with more than half of the patients progressing to second-line treatment where the standard of care has very limited activity. Our confidence in the LUMINIZE-203 study is further enhanced by the presentation of the final results of AFM-13104, an investigator-sponsored clinical trial of cord blood derived stem cells in combination with a symptomatic MDM disease. Final results, as shown on slide 11, were presented at the American Society of Hematology annual meeting in December last year. The final data demonstrated a meaningful duration of responses, including about 30 percent of the complete responses ongoing for more than a year, and first patients approaching now two years of relapse-free survival. I believe that this data is outstanding, especially if we consider that none of these patients had responded to the therapy that was given prior to the study. So, essentially, in a patient population with a 0% response rate to any available standard. 4EFM 28. This brings me to the update on our third clinical program. Our CD123 targeting innate cell engager is designed for patients with acute myeloid leukemia.

None: P T Seattle represents a high unmet medical need with more than half of the patients progressing to.

None: It's a second line treatment with standard of care has very limited activity.

None: Our confidence in the Lumi nice two or three study is further enhanced by the presentation of the final results of AFM 13, 104 study.

None: Investigator sponsored clinical trial of cord blood derived NK cells.

None: Combination with a symptom make at M D Anderson.

None: Final results as shown on slide 11.

None: Were presented at the American Society of Hematology annual meeting in December last year.

None: The final data demonstrated a meaningful duration of responses.

None: <unk> about 30% of the complete responses ongoing for more than a year and.

None: First patients approaching now two years of relapse free survival.

None: I believe that the state is outstanding.

Especially if we consider is that none of these patients had responded to the therapy as it was given prior to the study.

None: So essentially in a patient population with a zero percent response rate with any available standard of care.

None: Before you hear from 28.

None: This brings me to our update of our third clinical program.

None: Our C. D 123 targeting innate cell engaged are designed for patients with acute myeloid leukemia.

Michael Wolf: As we show on slide 14, we are pleased to report continued progress in this program. As we recently completed cohort 5 at 250 mg once weekly without encountering dose-limiting toxicity. Patient recruitment for cohort 6 is now open, which will be the final cohort of the phase 1 part of this program. Clinical safety and pharmacodynamic data from the study will be reported as guided in Q2, as well as an update on our strategy on how to advance the AFM 28 program. Now, let me pass the call over to Michael to highlight our financial operations results. Thank you, Andreas. Balance sheet and income statement highlights are shown on slides 16 and 17 of the presentation. A quick reminder that Affimed's consolidated financial statements have been prepared in accordance with IFRS, issued by the International Accounting Standard Board or IAS. Consolidated financial statements are prepared in Europe.

None: As we show on Slide 14, we are pleased to report continued progress in this program.

None: We recently completed cohort five at 250 milligrams once weekly without encountering dose limiting toxicity.

None: Patient recruitment for cohort six is now open which will be the final cohort of the phase one part of this program.

None: Clinical safety and Pharmacodynamic data of the study we reported S guided in Q2.

None: As well as an update on our strategy on how to advance the air from 28 program.

None: Now, let me pass the call over to Michael to highlight our financial operations results Michael Please.

Michael Wolf: Thank you Andreas.

Michael Wolf: Then sheet and income statement highlights are shown on slide 616, and 17 of the presentation.

Michael Wolf: A quick reminder, that automates consolidated financial statements have been prepared in accordance with IRS.

Michael Wolf: Issued by the International accounting standards Board or E. S. P.

Michael Wolf: Consider the consolidated financial statements are prepared in euros.

Michael Wolf: Since our financials are described in detail in the press release we issued this morning, I will only provide highlights on this. We ended 2023 with cash, cash equivalents, and investments of 72 million euros compared to 190.3 million euros on December 31st, 2022. Based on our current operating and financing plan, we anticipate that our liquidity will support operations into the second half of 2025. This takes into consideration a significant reduction in our operating cash burn compared to 2023, as a result of the actions we implemented and the focus on the development of our three clinical programs. Net cash used in operating activities for the year ended December 31st, 2023 was 110.3 million euros compared to 104.9 million euros in 2021.

Michael Wolf: Since the ultra Naturals are described in detail in the press release, we issued this morning I will only provide highlights on this call.

Michael Wolf: We ended 2023 with cash cash equivalents and investments of 72 million euros.

Michael Wolf: <unk> to 193.

Michael Wolf: In euros on December 31st 2022.

Michael Wolf: Based on our current operating and financing plan.

Michael Wolf: We anticipate that our liquidity will support operations into the second second half of 2025.

Michael Wolf: It takes into consideration a significant reduction in our operating cash burn compared to 2023.

Michael Wolf: As a result of the actions, we implemented and the focus of the on the development of our three clinical programs.

Michael Wolf: Net cash used in operating activities for the year ended December 31st 2023, plus $110 3 million euros compared to one of the $4 9 million euros in 2022.

Michael Wolf: Total revenue for the year ended December 31st, 2023, was €8.3 million, compared with €41.4 million for the year ended December 31, 2022. Revenue in 2022 and 2023, predominantly related to the Roiland and Ginente collaborations, for which we have now completed the work assigned to us under the respective collaboration agreement. Now, I'll turn the call back to Andreas for final remarks.

Michael Wolf: Total revenue for the year ended December December 31st 2023.

Michael Wolf: It was $8 3 million euros, compared with $41 4 million euros for the year ended December 31st 2022.

Michael Wolf: Revenue in 2022, and 'twenty two 'twenty three predominantly related to the Verizon and <unk> collaborations for which we have now completed the work assigned to us under the respective collaboration agreements.

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

Andreas Harstrick: Yeah, thank you, Michael. I think 2023 has been a very important and transformative year for Affimed. While it is not easy to reduce a workforce by up to 50 percent and let very committed and highly qualified employees go.

Andreas: Yeah. Thank you Michael.

Andreas: I think 2023 has been a very important and transformative year for a few minutes.

Andreas: While it is not easy to reduce our workforce by up to 50%.

Andreas: And let very committed and highly qualified employees go.

Andreas Harstrick: We believe that this strategic decision, a clear focus on our three key clinical programs, is in the best interest of the company, of our shareholders, and of our patients. We have laid important foundations across all three clinical programs for 2023. And this groundwork will enable us to deliver meaningful data readouts in 2024 and beyond. For all three clinical programs, we have established dosing regimens for further development that are based on solid dose effect evaluation, including clinical, safety, and pharmacodynamic parameters. For symptomatic, we have a clear pathway to initial approval through our LUMINIZE-203 study, and we are executing on this. For AFM24, we have identified the lead indication and the lead combination for further possible approval targeting clinical development. And for AFM28, we have established a dose range that can be carried forward into further clinical development. And we have built an organization of highly experienced professionals with proven track records to run large clinical programs all the way to approval. As shown on slide 18.

We believe that's a strategic decision was a clear focus on our three key clinical programs.

Andreas: In the best interest of the company.

Andreas: Our shareholders and our patients.

Andreas: We have laid important foundations across all three clinical progress in 2023.

Andreas: And this groundwork will enable us to deliver meaningful data readouts in 2024 and beyond.

Andreas: For all three clinical programs, we have established the dosing regimens for further development that are based on solid dose effect evaluations.

Andreas: Including clinical safety and Pharmacodynamic parameters.

Andreas: For a symptomatic we have a clear pathway to initial approval through our lumi Nice 203 study and we are executing on this.

Andreas: Before I hear from 24, we have identified the lead indication.

Andreas: And the lead combination for first though possibly approve of targeting clinical development.

Andreas: And for you from 28, we have established a dose range that can be carried forward into further clinical development.

Andreas: And we have built an organization of highly experienced professionals with proven track records to London to run large clinical programs all the way to approval.

Andreas: As shown on slide 18.

Andreas Harstrick: We will provide additional data readouts for both non-small cell lung cancer cohorts in the AFM24102 study in Q2. Furthermore, we will have initial readouts for the LUMINIZE-203 study, and we will provide a status update on AFM28 in the same time frame as well. Looking further ahead, we expect the final response readout for the full 40-patient cohort with EGFR-Y type non-small cell lung cancer in Q4 2024, and the mature PFS data from the EGFR mutant non-small cell lung cancer cohort in Q3 2020.

Andreas: We will provide additional data readouts for both non small cell lung cancer cohorts.

Andreas: F. 'twenty 4102 study in Q2.

Andreas: Furthermore, we will have initial read outs for the lumi nice two or three study.

Andreas: Andrew will provide a status update on <unk> from 28 in the same timeframe as well.

Andreas: Looking further ahead, we expect the final response readout for.

Andreas: For the full 40 patient cohort with Egfr wild type non small cell lung cancer in Q4, 'twenty 'twenty four.

Andreas: And it's a mature PFS data from the Egfr mutant non small cell lung cancer cohort in Q3 2024.

Andreas Harstrick: We remain focused on our mission to deliver innovative treatments for patients in need and to increase the value for our shareholders. As we navigate through this transition, we are committed to keeping you informed and engaged, and we appreciate your ongoing support.

Andreas: We remain focused on our mission to deliver innovative treatments for patients in need.

Andreas: And to increase the value for our shareholders.

Andreas: As we navigate through this transition we are committed to keeping you informed and engaged and we appreciate your ongoing support.

None: And with this I would give us a call back to the operator to start the Q&A session. Thank you.

Operator: Ladies and gentlemen, as a reminder to ask a question, please press star 1-1 on your telephone and then wait to hear your name announced. To withdraw your question, please press star 1-1 again. Please stand by while we compile the Q&A roster. Our first question comes from a line from Srikripa Devarakonda with Truist. Your line is open.

None: Thank you.

None: Ladies and gentlemen, as a reminder to ask a question. Please press star one on your telephone and then wait to hear your name.

None: So withdraw your question Please press star one.

Operator: Please standby.

Operator: Ross.

Yes.

Ross: Our first question comes from Atlanta, So Quebec.

Ross: Your line is open.

Andreas Harstrick: Hey guys, thank you so much for taking the time to answer my questions. Um, you know, given that Luminize 203 has been advancing, um... Can you provide a little bit more clarity on how many patients we will see data from, what we see from all the patients enrolled, and in terms of duration on therapy for these patients, can you help us understand the bookends, like what is the longest time patients have been on, and what is the, you know, minimum amount of time they've been on? And just regarding the Safety Review Committee meeting that you're expected to have in April for the initiation of Cohorts 3 and 4. I just wanted to confirm that you do not need any additional conversations with the FDA before you move into Cohorts 3 and 4.

Ross: Yeah.

Hey, guys. Thank you so much.

Quebec: For taking my question you know.

Quebec: Given that.

Quebec: <unk> been advancing.

Quebec: Can you provide a little bit more clarity on.

Quebec: How many patients we will see data from the B keep them all of the patients.

Quebec: And in terms of duration on therapy for these patients can you help us understand like what is the longest nine patients have been on and what does that mean.

Quebec: The amount of time they've been on.

Quebec: And just regarding the safety review Committee meeting that you expected to have an E learning.

Quebec: Patients in cohorts three and four you just wanted to confirm that you don't need any additional conversations with the FDA before you move into cohorts three and four thank you.

Andreas Harstrick: Thank you. Okay, thank you, Srikripa. That was quite a lot of questions, so I hope I remember all of them. So to start with the SRC meeting, no, we do not need any conversation or any feedback with FDA. We have clear guidelines that govern the transition from court 1 to 2, to court 3 and 4, and this can be handled by the SRC meeting.

None: Okay. Thank you script.

None: That was quite a lot of questions. So I hope I remember all of them.

So to start with the Src meeting no we do not need any.

None: Conversation or any feedback with F D a.

None: Yeah guidelines that governs the transition from cohort one to two two cohorts three and four and this split can be handled by the Src meeting only.

Andreas Harstrick: As far as the data that we expect in Q2, we believe that we have – well, we are quite certain that we have fully recruited cohorts 1 and 2, so this will be 12 patients. Now again, courts three and four, the first three patients have this staggering enrollment, where basically you assign a slot to a patient, start this patient, then two weeks later you can assign the next slot, start the next patient, provided that this patient does not drop out during the screening period. This happened to a couple of patients in court one and two, and then you have to restart the slot allocation process again, which caused somewhat of a little delay for the first six patients in court one and two.

None: As far as the data that we expect.

None: In Q2.

None: We believe that we have but we are quite certain that we have a.

None: Fully recruited cohorts, one and two so this would be 12 patients now.

None: Now again courts reinforces the first three patients has is staggering enrollment.

None: Where basically you assign a slot to a patient can start this patient. So in two weeks later you kind of signs of next slot to start some X patient provided that this patient drops not curing the screening period, just happened to a couple of patients in cohorts, one and two and then you have to restart the slot allocation process again, which.

None: Cost somewhat a little delay in the first six patients in cohort one and two.

Andreas Harstrick: Again, it's a little bit hard to predict, but we expect to have a reasonable number of cohorts, three and four patients, for our initial research. The important thing also to note is that we expect that the data of cohorts 1 and 2 will already be very informative as we are using a cell dose of 3-cell applications of 2 billion cells each per cycle that we believe is a therapy.

None: Again, it's little bit hard to predict but we expect to have a reasonable number of cohorts three and four patients for our initial reporting Q2 as well.

None: Important probably also to note is that we expect that the date of cohorts, one and two will already be very informative as we are using a cell dose of <unk>.

Free cell applications of 2 billion cells each per cycle that we believe is a therapeutic cell dose.

Andreas Harstrick: I hope I have covered all of your questions. If something remains open, please ask again. I'm not sure that I have covered everything.

None: Okay, I hope I have covered all of your questions.

None: It remains open. Please please ask again I'm not sure that I covered everything.

Operator: Okay. Thank you. Please stand by for our next question. Our next question comes from the line of Daina Graybosch with Lirik Partners. Your line is open.

None: Thank you.

None: Thank you.

None: Please standby for our next question.

Speaker Change: Our next question comes from the line of Dana Great Boss with Leerink Partners. Your line is open.

Andreas Harstrick: Thank you. Thanks, guys, for the question. On the two Q updates, and I'm probably most interested in AFM24 and then C-CAMEG next, what kind of translational data do you expect you'll be able to provide that could or could not be supportive of the clinical signal that you're observing and would explain why these patients, the lung cancer patients, didn't respond to PD-1 but did have a response to AFN-24 plus the TESRA? Yeah, so we will have some translational data, mainly on blood, so looking at cytokines. For this study, we have not implemented mandatory serial biopsies.

Speaker Change: Thank you. Thanks, Scott is further question on that.

Speaker Change: Q2 update.

Speaker Change: Most interested in anthem 24.

Speaker Change: Uh huh.

Speaker Change: What kind of translational data do you expect you'll be able to provide.

Speaker Change: That could or could not be supportive of the clinical signal that you're observing.

Speaker Change: Blaine Whiting patient.

Speaker Change: The lung cancer patient.

Speaker Change: Didn't respond to PD, one that did have a response.

Speaker Change: 24, plus.

Speaker Change: Okay.

None: Yeah. So we will have some translational data mainly on blood so looking at cytokines.

None: For this study we have not implemented mandatory serial biopsies.

Andreas Harstrick: However, what we have shown and also published. In our AFM24 monotherapy study, we first of all, in circulation, we see an increase in activation markers for NK cells but also an increase in activation markers for T cells. In serial tumor biopsies, we see an increase in infiltration of NK cells as well as an increase in infiltration of T cells. We believe that these data clearly indicate that you have crosstalk between the innate and the adaptive immune system. Most likely, the NK cell-mediated tumor cell killing leads to the availability of additional tumor-related antigens which are processed by dendritic cells, and we know that AFM24 also has activity on the macrophage part of the innate immune system, which then can trigger additional novel tumor-specific...

None: However, what we have shown and also published in.

None: In our <unk> from 24 mono therapy study we have seen.

None: First of all in circulation, we see an increase in activation markers for NK cells, but also an increase in activation markers for T cells in serial tumor biopsies, we see increase in infiltration of NK cells as well as increasing the infiltration of T cells.

None: We believe subsea state. It clearly indicates that you have a cross talk between an agency adaptive immune system.

None: Most likely as the NK cell mediated tumor cell, killing leads to availability to liberation of additional tumor related antigens.

None: Our processed by dendritic cells, and we know that they have from 24 also has activity on the macrophage are part of the innate immune system, which then can trigger additional novel tumor specific T cell clones.

Andreas Harstrick: So this is our working hypothesis and this is also our explanation for why we believe that, if you will, we can break PD-1 resistance, so we make patients responsive to this combination treatment who have never had a response. Let me restate though, so you have already presented a lot of preclinical and clinical work that supports this mechanism. So our expectations should not be too high for correlative translational support in this next update. Is that fair?

None: So this is our working hypothesis and this is also our exploration and why we believe that.

None: If you will be can break a PD one resistance. So we make patients responsive to this combination treatments that have never had a response to PD one.

None: Okay.

None: Let me restate, though so you you haven't you've already presented a lot of.

None: Preclinical and clinical work that supports the mechanism.

None: Spectation should not be too high for our Cortland and <unk>.

None: Translation of the Port and this next update is that fair and what's your expectations there.

Andreas Harstrick: And what should our expectations then be for the end of the year? That is fair. So the focus of our updates in Q2 will really be on the clinical data, most importantly on progression-free survival in this initial non-sponsor lung cancer cohort and the response readout for the EGFR mutant. And then what should we expect in the 40 patient cohort at the end of the year in terms of the type of data that you'll have? The 40 patients, of course, will provide a significantly broader database, again with response data and progression-free survival data for the 40 patient data set, as well as PFS data for the EGFR mutant.

None: That is fair. So is the focus of our updates in Q2 will really be on the clinical data. Most importantly on progression free survival. In this initial non small cell lung cancer cohort and the response read out for the Egfr mutant non small cell lung cancer cohort.

None: And then what should we expect in the 40 patient cohort.

None: The type of data that you'll have.

None: Well the 40 patients of course will provide a significantly broader database again.

None: Response data and progression free survival data for the full 40 patients dataset as well as the PFS data froze Egfr mutant non small cell lung cancer cohort.

Andreas Harstrick: Okay, thank you very much. Thank you. Please stand by for our next question. Our next question comes from the line of Maurice Raycroft with Jeffries. Your line is open. Hi, this is Kevin on behalf of Morey.

None: Okay.

None: Okay. Thank you very much.

None: Thank you.

None: Please standby for our next question.

None: Our next question comes from the line of Maury Raycroft with Jefferies. Your line is open.

Operator: Thanks for taking. That's the first one, just a follow-up on AFM 13. Could you characterize the experience you're seeing so far with this trial and whether it's similar to the MD Anderson experience? Particularly with respect to And then for the data updates in the second quarter, especially for the AFM24 update, are you just saying whether that's going to be at ASCO or potentially? Yeah, so for the first question, as we have guided, we will give the first update both on safety and efficacy in Q2 when we have a meaningful number of patients. So today I can only comment on recruitment, which I don't think we addressed already for the AFM-24 study. We have not yet decided what the right or the venue will be.

None: Hi, This is Kevin on for Maury, Thanks for taking our questions. Just the first one just to follow up on the AFM 13.

Kevin: Could you characterize the experience you're seeing so far with this trial in and whether it's similar to the to the M. D. Anderson experience, particularly with respect to safety and efficacy and then further data updates in the second quarter, especially for the anthem twenty-four update or you just are you, saying, whether that's gonna be it <unk>.

Kevin: Or potentially a company.

Kevin: Yes.

None: Yeah. So for the first question, yes, we have guided we will get the first update both on safety and efficacy in Q2, when we have a meaningful number of patients. So today I can only.

None: Comment on the recruitment and so this I think we addressed already.

None: For E F F 'twenty for a study.

None: We have not finally decided what's the right or as easy as the venue will be.

Andreas Harstrick: As you know, ESCO will notify you on the program over the next couple of days, and this will guide our programs or our operations, how and when to do it. Great, thanks. And just one more on AFM 28. It seems like the focus here is potentially on the combination. Can you talk about when you could potentially start that? We're talking with potential partners here for, [inaudible] Yeah, yeah, you're right. We believe that the main focus, if you look at the biology of AML, will be the development in combination with an allogeneic NK cell.

None: As you know ESCO with notify owns a program over the next couple of days, just with guide our programs or our own plans, how and when to disclosing which for them to disclose all of these data.

None: Great. Thanks, and just one more on I'm 28, it seems like the focus here is potentially on the combination can you talk about when you could potentially start that and if you're talking with potential partners here for.

None: For allogeneic encase.

None: Yeah. Yeah, you are right. We believe sets a main focus if you look at the biology of a M. L will be developed in combination with an allogeneic NK cell.

Andreas Harstrick: And, as I said during my talk, we will provide an update in Q2. I would like to thank all of you for listening. Thank you. Thank you. Thank you. Please stand by for our next question. As a reminder, ladies and gentlemen, if you'd like to ask a question, please press star 11 on your telephone. Our next question comes from the line of Yanan Zhu with Wells Fargo. Your line is open. Hi, thanks for taking our question. This is Kwan-Aung Bui-Yan.

None: And as I said during my talk we will provide an update in Q2.

None: Including a detailed plan how to move forward.

None: Great. Thanks.

None: Thank you.

None: Please standby for our next question.

None: As a reminder, ladies and gentlemen, if you'd like to ask a question. Please press star one on your telephone.

Speaker Change: Our next question comes from the line of your non shoe with Wells Fargo. Your line is open.

Speaker Change: Hi, Thanks for taking our question Dr. Kwan for Yanan, So you mentioned that there.

Operator: So you mentioned that there were, sorry, it's 4 a.m. Thirteen. You mentioned that the enrollment in courses one and two was slower. I wonder if you can share any color pictures of the patient who dropped out. What's the rate of drop?

Yanan: It's both.

Yanan: <unk> you mentioned either in Romania in cohorts, one and two at solar.

Yanan: Due to staggering in patient dropout.

Speaker Change: Wonder if you can share any colors on the patients who drop out and what's their radar a jump off thank you.

Andreas Harstrick: Yeah, so the reasons for dropout were very heterogeneous and, as it happened during the screening period, obviously not related to any treatment. One of the patients, for example, who was already about two and a half weeks into the screening period, acquired a COVID infection. We then waited for the COVID infection to clear, but this patient, who was an elderly patient, had a remaining or residual impairment in his lung. So this was one of the reasons for dropout.

Speaker Change: Yeah.

Yeah, so the reasons for dropout.

None: Heterogeneous and that's.

None: As it happened during the screening period, obviously not related to any treatment.

None: One of the patients for example.

None: Who was already about two and a half weeks in the screening period, a quiet the COVID-19 infection.

None: Are we waiting for the Covid infection to clear however, this patient alright.

None: Alright. So this was an elderly patient had a remaining or residual impairment in this lung function.

None: It was one of the reasons for drop out we.

Andreas Harstrick: We had a second patient who acquired a CMV infection, again not clearing and then dropping out. These are only a few patients, but again, as you can only assign one cohort at a certain period of time, this always delays the refilling of the next slot by three to four.

None: We had a second patient who acquired the CMV infection again, not clearing and then dropping out so it's.

None: It's only a few patients but again as you can only assign one cohort at one slot.

None: A certain period in times as always will be lazy refilling also next slot plus three to four weeks.

Andreas Harstrick: Again, we are through the staggering period now. Now we can recruit in parallel, and good recruitment, which gives us confidence.

None: Again, we are stewards of struggling period now now we can recruit in Palo Alto and we see good recruitment, which gives us confidence that by Q2, we will report data on 12 patients from cohort one and two and then.

Andreas Harstrick: By Q2, we will report data on the 12 patients from cohorts 1 and 2, and then a certain number of... Got it. That's very clear. Thank you. And any comment on the safety you have seen so far? Is there any difference compared to what you saw in the NDA study?

None: Number of patients from cohorts three and four.

None: Got you that's very clear thank you and any color on the safety you have seen so far is it is there any difference compared to why do you have seen in your NDA study. Thank you.

Andreas Harstrick: Again, we will provide a more detailed safety update in Q2, however, we are very confident with the progression through the SRC, so we have not encountered any problems with dosing. Thank you so much for listening. Thank you. Ladies and gentlemen, that concludes our Q&A portion for today. Thank you for your participation in today's conference call. You may now disconnect. Everyone have a wonderful day.

None: Again, we will provide more detailed safety update in Q2.

None: However, we are very confident with the progression Susie Src. So we have not encountered any dose limiting toxicities or anything like that.

None: Got it. Thank you so much for the color.

None: Thank you.

None: Ladies and gentlemen that concludes our Q&A portion for today.

None: Thank you for your participation in today's conference call.

None: You may now disconnect everyone have a wonderful day.

None: Okay.

None: Okay.

None: [music].

None: Okay.

None: Okay.

None: [music].

None: Okay.

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