Affimed - Q2 2022
August 11, 2022
Transcript
Operator (participant)
Good day, everyone, and welcome to the Affimed Second Quarter 2022 Financial Results and Corporate Update conference call. My name is Vanessa, and I will be your operator for today's call. At this time, all participants are in a listen-only mode. Later, we will conduct a question-and-answer session. During the question-and-answer session, if you have a question, you can enter the queue by pressing zero then one on your touch-tone phone. As a reminder, this conference is being recorded. I would now like to introduce your host for today's call, Mr. Alex Fudukidis, Head of Investor Relations at Affimed. Sir, you may begin.
Alex Fudukidis (Head of Investor Relations)
Thank you, Vanessa, and thank you all for joining us today for our call. Before we begin, I'd like to remind everyone that we issued the relevant press release earlier today, which can be found on the investor relations section of our website. On the call today, we have members of our management team, including Adi Hoess, our Chief Executive Officer, Andreas Harstrick, our Chief Medical Officer, Arndt Schottelius, our Chief Scientific Officer, Denise Mueller, our Chief Business Officer, and Angus Smith, our Chief Financial Officer. The team will be available for the Q&A session after the prepared remarks. Before we start, I'd 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. These forward-looking statements are subject to risks and uncertainties, and actual results may differ materially from those expressed or implied in these statements due to various factors, including, but not limited to, those identified under the section entitled Risk Factors in our filings with the SEC and those identified under the section entitled Forward-Looking Statements in the press release that we issued today and filed with the SEC. With that, I'll turn the call over to Adi. Adi?
Adi Hoess (CEO)
Thank you, Alex. Good day everyone, and thanks for joining our second quarter 2022 financial results and operational progress update call. We at Affimed, we have a clear vision and goal to be the leading innate cell-engaging company and to stop cancer from derailing patients' lives. At AACR this year, we presented groundbreaking data from the combination of AFM13 with NK cells in relapsed refractory Hodgkin lymphoma patients. Having achieved a 100% objective response rate is particularly impressive given the fact that these patients had undergone a median number of seven prior lines of therapy, and in most cases had exhausted all approved and experimental therapies. Since the data were presented, the study has continued to enroll well, underscoring the high need for novel options for these patients.
Now, we believe our innate cell engager technology through its bispecific and tetravalent structure with a very high affinity binding to CD16A on natural killer cells and macrophages without the competition from circulating immunoglobulins is at the core of these impressive results. The unique attributes of our technology have enabled us to demonstrate meaningful antitumor activity for our in situ engager molecules as monotherapy and in combinations, including a strong synergy with PD-1, PD-L1 checkpoint inhibitors, and most recently in combination with natural killer cell presence. We're indeed very excited about the many upcoming data readouts across the three-pronged strategy approach, and today I will summarize our expectation for the remainder of this year. Moving to slide four. For AFM13, we show that we have two ongoing studies.
For the registration-directed study for AFM13 as monotherapy in relapsed and refractory peripheral T-cell lymphoma, also known as REDIRECT, we remain on track to deliver top-line data in the fourth quarter of this year. The study enrolled more than 100 relapsed and refractory PTCL patients, and the focus of the initial data release will be on the overall response rate as assessed by a blinded independent review committee and a preliminary assessment of the duration of response. Just as a reminder, PTCL is a disease with a significant unmet need. There are nearly 1,500 patients just in the U.S. each year with relapsed or refractory PTCL. Treatment options are very limited and the prognosis for these patients remains very poor.
The second AFM13 study is the phase I/II study in collaboration with the MD Anderson Cancer Institute, evaluating cord blood-derived natural killer cells pre-complexed with AFM13, followed by single agent AFM13 treatment, again in patients with relapsed refractory CD30-positive lymphoma. Data presented at this year's AACR conference by Dr. Yago Nieto, the lead investigator of the trial at MD Anderson, demonstrated that after a second cycle of treatment, the complete response rate at the recommended phase II dose increased from 38%, as reported in December 2021, to 62%. This was achieved in 13 patients. The overall response rate remained at 100%, and the treatment was determined safe and very well tolerated by patients, which is now allowing MD Anderson to continue to treat patients with up to four cycles.
Durability of response data presented for patients treated at the recommended phase II dose was also promising. Of the eight patients who achieved a complete response, seven remained in complete response at a median follow-up of 6.5 months, including two patients who had remained in response after 10 months, and two who received a consolidation autologous stem cell transplant. Enrollment in this study is progressing very well. As of July 31st, 30 patients have now been treated, including 24 at the recommended phase II dose of 1 × 10^8 cord blood-derived NK cells per kilogram, which represent an additional 11 patients treated at that dose since our latest data update at AACR.
Important to note here is that based on the amended protocol, some patients have now received up to four cycles of treatment, and new patients are being enrolled at the recommended phase two dose. We're expecting that Dr. Yago Nieto will report updated data from the study at a major scientific conference in the fourth quarter of this year. We're also progressing very well with our NK cell strategy to ensure access to an off-the-shelf cryopreserved NK cell for further development with our innate cell engager molecules. We expect to announce a development path for AFM13 with a specific NK cell again in the second half of 2022. Now let me jump to AFM24.
As shown on slide five, we continue to enroll patients in all three ongoing studies, including the expansion cohort for our monotherapy study and the dose escalation for the combination studies, one with atezolizumab and the other one with the SNK01 autologous NK cell product from NKGen. As we discussed on our last call, we completed the dose escalation part of the monotherapy study and determined and confirmed the 480 mg weekly dose as our recommended phase II dose. We're continuing to enroll patients in the expansion phase of the monotherapy at the recommended phase II dose. The expansion cohorts include patients with renal cell carcinoma, non-small cell lung cancer, and colorectal cancer.
Updates from the monotherapy study, including clinical data from the dose escalation phase, will be presented at ESMO, and a further update with correlative science data is expected to be presented at a scientific conference later this year. We are also continuing to enroll patients in the dose escalation phase of the two combination studies. The primary purpose of the dose escalation phase of these studies is to establish the safety of the two combinations and identify the recommended phase II dose for the dose expansion phase. In AFM24-102, this is the combination of AFM24 with atezolizumab, we are treating patients with non-small cell lung cancer, gastric cancer, and a basket comprising pancreatic adenocarcinoma, biliary tract cancer. In this study, we have completed the first dose cohort and are enrolling into the second cohort at 480 mg, which is the recommended phase II dose of AFM24.
A presentation of such data from this study is expected at the scientific conference in the fourth quarter of this year. Our second combination study, called AFM24-103, is investigating the combination of AFM24 with SNK01, which is an autologous NK cell product from a company called NKGen Biotech. This is investigated in patients with non-small cell lung cancer, squamous cell carcinoma of the head and neck, and colorectal cancer. In this study, we are nearing completion of cohort 1, which is treating patients at 160 mg of AFM24 and a fixed dose of SNK01, and an update is planned based on progress. Moving to AFM28, our third wholly owned innate cell engager targeting CD123 in patients with AML. As planned, we submitted an IND to the FDA in June.
Following discussion with the FDA regarding the IND and specifically the design of the dose escalation, we have taken a strategic decision to focus early clinical development of AFM28 outside the U.S. We believe this decision will enable us to conduct the dose escalation and identify the recommended phase II dose faster. We now expect to initiate the clinical study in the first half of 2023. We intend to re-engage with FDA after data from the dose escalation has been generated. As we've mentioned, AML is one of the worst blood cancers with poor patient prognosis, especially in the relapsed or refractory setting, with no standard of care salvage regimen currently available.
Given the aggressive nature of the disease and desperate need for viable treatment options, it is a high priority for Affimed to be able to offer this treatment option for such AML patients as quickly as possible. We believe this strategy will help to achieve this goal. Finally, we're also advancing our work with existing partners. In the case of Genentech, we've made good progress in various pre-clinical programs and handed over several programs to them for further pre-clinical development. In our partnership with Roivant, AFM32, or called by Roivant AFVT-2101-33, is currently being investigated in R&D enabling studies. We are eligible for additional proceeds from these key collaborations in the near term, including pre-clinical milestones as well as milestones based on early regulatory achievements.
We're continuing to build on our core strengths and competencies to deliver on the goals that we have set for ourselves for the next few months, and we are building the foundation to drive value for shareholders and patients alike for 2022 and beyond. With that, I'm turning over the call to Angus to give you an update on the financial position. Angus?
Angus Smith (CFO)
Thank you, Adi. Balance sheet and income statement highlights are shown on slide six and seven of the presentation. Affimed's consolidated financial statements have been prepared in accordance with IFRS, as issued by the International Accounting Standards Board, or IASB. The consolidated financial statements are prepared in euros, which is the company's functional and presentation currency. Therefore, all financial numbers that I'll present in this call, unless otherwise noted, will be in euros. As of June 30th, 2022, cash and cash equivalents totaled EUR 237.2 million compared to EUR 197.6 million on December 31st, 2021. Based on our current operating plan and assumptions, we anticipate that our cash and cash equivalents will support operations into mid-2024.
Net cash used in operating activities for the quarter ended June 30th, 2022 was EUR 26.5 million, compared with EUR 17.3 million for the quarter ended June 30th, 2021. Total revenue for the quarter ended June 30th, 2022 was EUR 7.3 million compared with EUR 9.7 million for the quarter ended June 30th, 2021. Revenue predominantly relates to the Genentech and Roivant collaborations. R&D expense decreased by 4% from EUR 21.8 million in the quarter ended June 30th, 2021 to EUR 20.8 million for the quarter ended June 30th, 2022. The decrease was primarily due to lower expenses associated with the development of the AFM13 and AFM24 programs, largely a result of the decrease in the procurement of clinical trial material.
General and administrative expenses increased 54% from EUR 5.4 million in the quarter ended June 30th, 2021 to EUR 8.4 million in the quarter ended June 30th, 2022. The increase predominantly relates to higher personnel and share-based payment expenses and an increase in insurance premiums. Net finance income or cost increased from costs of EUR 1.6 million for the quarter ended June 30th, 2021 to income of EUR 2.3 million for the quarter ended June 30th, 2022. Net finance income or cost is largely due to foreign exchange gains and losses related to assets denominated in U.S. dollars as a result of currency fluctuations between the U.S. dollar and the euro during the year.
Net loss for the quarter ended June 30th, 2022 was EUR 19.4 million or EUR 0.13 per common share, compared with a net loss of EUR 18.8 million or EUR 0.16 per common share for the quarter ended June 30th, 2021. The weighted number of common shares outstanding for the quarter ended June 30th, 2022 was EUR 147.3 million. Additional information regarding these results is included in the notes to the consolidated financial statements as of June 30th, 2022, which will be included in Affimed's filings with the U.S. Securities and Exchange Commission. I will now turn the call back to Adi for closing remarks. Adi?
Adi Hoess (CEO)
Yeah, thanks a lot, Angus. As we show on slide eight, we are continuing to advance our key programs forward with a focus on delivering many meaningful updates for our key programs in the second half of this year. Indeed, I'd like to thank you for all your continued support, in particular patients and their families, and for our employees in the U.S. and Europe who are continuing to do the best they can in supporting our efforts to move things forward. We're now open to take questions. Thank you. Operator?
Operator (participant)
Thank you. We will now begin our question and answer session. If you have a question, please press zero then one on your touch tone phone. If you wish to be removed from the queue, please press zero then two. If you're using a speakerphone, please pick up the handset first before pressing the numbers. Once again, if you have a question, please press zero then one on your touch tone phone. Please stand by while we assemble our queue. Once again, that's zero then one to queue up with your question, please. We have our first question from Daina Graybosch with SVB Securities.
Daina Graybosch (Senior Managing Director)
Hi. Thanks for the question. Maybe two regulatory questions, one on AFM24. Can you talk more about the feedback from FDA, whether it's AML-specific or CD123 or molecule specific, their reservations that would lead to the dose escalation being more slowly? Sort of second regulatory question, wondering if you've had a chance to prepare further for a meeting or you can talk about a future meeting with FDA on AFM13 fast forward. Thank you.
Adi Hoess (CEO)
Yeah, Daina, thanks for the questions. I will hand over to Andreas. Andreas?
Andreas Harstrick (Chief Medical Officer)
Yeah. Hi, Daina. Just to be sure, I think your first question was relating to AFM28 and not to AFM24, right?
Daina Graybosch (Senior Managing Director)
Oh, correct. I'm sorry, AFM28. I misspoke.
Andreas Harstrick (Chief Medical Officer)
Okay. Yes. No, so as we said, we have made the strategic decision after discussions with FDA. We cannot share a lot of details about these discussions, as you know, they are confidential with regulators. What we can say, though, is that there was no specific concerns about CD123 as a target. To the second question, as we have stated previously, our intention is to have a regulatory interaction. It is a meeting with FDA concerning the next steps forward for a development of AFM13 in combination with NK cells this year, and we are sticking to this guidance. This is our intention.
Daina Graybosch (Senior Managing Director)
Okay. To clarify, that meeting hasn't happened, and you're not guiding to a specific timeframe for that meeting yet other than probably this year.
Andreas Harstrick (Chief Medical Officer)
Our intention is to have those meetings this year, but we have not guided to a specific timeframe, and it obviously has not happened yet.
Daina Graybosch (Senior Managing Director)
Great. Thank you very much.
Operator (participant)
Thank you. We have our next question from Kripa Devarakonda with Truist Securities.
Speaker 11
Hi. Thanks for taking the question. This is Alex on for Kripa. We had a question about third-party NK manufacturing, which is a question we get a lot from investors. Can you talk a little bit about, you know, the challenges or considerations that go into finalizing a third-party NK manufacturer, what metrics you're looking at, and also how that might affect different partnerships that you have going on with other NK cell companies? Thanks.
Adi Hoess (CEO)
Yeah. Thanks for this question on the NK cell product. As we've stated recently, what Affimed has been addressing in a broad manner is to understand the partners' manufacturing and the, let me call it NK cell quality itself. We have a number of internal assays established that allow us to identify the best partners in terms of NK cell products. We have in general seen that there is a good number of NK cell products out there that synergize well with an innate cell engager almost independent of source. Cord blood-derived peripheral, but even iPSC-derived NK cells synergize with our innate cell engagers.
What we have been focusing on recently in terms of now moving forward is to be able to entertain a registration-directed study so that requires a partner to have substantially made progress in terms of NK cell manufacturing so that not only the quality can be provided, but also the quantity. We have identified such parties and are in the process of finalizing the business agreement.
Speaker 11
Okay. One follow-up on the AFM13 monotherapy trial. Can you remind us what's the bar for the monotherapy, duration, efficacy, how you're thinking about it? Also remind us about the development strategy, after you get the top line data we expected this year. Thanks.
Adi Hoess (CEO)
Yeah. I'll hand this over to Andreas. Andreas?
Andreas Harstrick (Chief Medical Officer)
Yeah. For the efficacy bars, again, we looked at drugs that have received accelerated approval. In the PTCL setting, there are three drugs which have this, the response rate was remarkably similar for all three drugs of 27%-28%. This gives us a certain guidance about the response rate. Duration of responses in these trials were in the range around 8 ± 1 months, which again, is a guidance for us or what we are looking for in terms of durational responses. Of course, FDA will never give you a concrete number, so they will always state that the review will be a review issue.
I think the consistency of the data with all three drugs that have reached accelerated approval provides us with a pretty good guide rail, I would say. What was your second question on?
Speaker 11
It was about the next steps following the top line data readout later this year with monotherapy.
Andreas Harstrick (Chief Medical Officer)
The next steps, of course, as we said, we will provide top-line data from the study, and then of course, the next step is to enter into interactions with regulatory agencies, primarily with the FDA, to discuss the next steps. As we said, our intention is that the study should be registration-directed, and so we will have discussions with the regulators about that.
Speaker 11
All right. Thanks for taking the question, and congrats on the progress.
Operator (participant)
We have our next question from Maury Raycroft with Jefferies.
Maury Raycroft (Equity Research Analyst)
Hi, thanks for taking my questions. I was gonna ask one on manufacturing partner for AFM13 combo as well. Is this something that you need to have in hand or figured out when you meet with FDA later this year to discuss the combo? What sort of evidence would you need to bring to the FDA with regard to this potential NK cell combo partner in order to move directly into a registrational study?
Adi Hoess (CEO)
Thanks, Maury, for this question, and obviously we can appreciate that there are a lot of questions out there that need to be evaluated and then discussed. We have taken the position here is that we have gained a substantial amount of know-how through our own work and also through what partners do. The know-how we have is what we're consolidating now to move forward and discuss as a composite with FDA. We're then expecting their feedback and the details. At the moment, what we can say is that we have, in our minds, identified a partner that can fulfill all this requirement.
Unfortunately, I cannot go into any further detail along this as obviously the meeting with FDA, which we're already preparing in advance in preparation, that will then give us the resolution that we can share with you later on.
Maury Raycroft (Equity Research Analyst)
Got it. That's helpful. Sounds like you have identified a partner then. Is that fair, just to clarify or?
Adi Hoess (CEO)
Well, again, without going into detail, as we've said, we're in the execution of a business agreement, so that.
Maury Raycroft (Equity Research Analyst)
Okay.
Adi Hoess (CEO)
In principle is confirming that we have identified. If it's one partner, multiple partners, whoever it is, that remains to be disclosed at the time when we're finished with it. Yes, we have seen in the field that there are companies out there that can fulfill the requirements that I just mentioned.
Maury Raycroft (Equity Research Analyst)
Got it. Okay. Makes sense. Also wanted to ask a question on AFM24. We see that you're gonna have a poster at ESMO. Just wanted to clarify on that one, whether you could potentially include some expansion monotherapy data in that poster or, if you can talk more about what that update's gonna be.
Adi Hoess (CEO)
Andreas, can you take this question?
Andreas Harstrick (Chief Medical Officer)
Yeah. As we or as Adi has said, I think, during the presentation, the ESMO poster will mainly focus on the additional data from the dose escalation part, so the 720 mg cohort, which is now in a sufficient degree of follow-up. Then, data from the expansion cohorts will be released as they become available. ESMO will mainly focus on the dose escalation part.
Maury Raycroft (Equity Research Analyst)
Got it. Okay. For the IO combo update in fourth quarter, can you talk about how much data we could see for that update?
Andreas Harstrick (Chief Medical Officer)
Again, it's an ongoing study. As Adi said, the atezolizumab study we have completed of the dose escalation part 1, without DLTs. We are actively recruiting at 480 mg, and will be able if we confirm that this is also in combination the recommended phase II dose. We will be able then to open the expansion cohorts. This is the data set that we will have most likely towards the end of the year, mainly from the dose escalation part.
Maury Raycroft (Equity Research Analyst)
Got it. Okay. Thanks for taking my questions.
Operator (participant)
Thank you. Our next question comes from Li Watsek with Cantor.
Li Watsek (Biotech Equity Research VP)
Hey, guys. Thanks for taking my question. I guess first just on AFM13 with NK combo, I guess for the data that you're gonna present later this year, I guess what are you looking to learn from that data set? Since like you have 24 patients. The RP2D dose and, patients can receive up to four cycles. Maybe just talk about what would be the focus for investors there.
Andreas Harstrick (Chief Medical Officer)
Yeah, I can take this question again. As we said, we will have much more patients. Of course, we will also report on the patients that were part of the AACR disclosure earlier this year. Now, all these patients will have a significantly longer follow-ups, I think, for the first, let's say, 12 patients or so. We will have really long follow-up, which I think will allow a significantly better estimate of duration of responses, in addition to, of course, response data from the newly recruited patients. The other thing, and I know there's always a lot of discussion about doing multiple lymphodepletions.
As Adi said, we have patients who have now received three and four cycles, so there will also be a safety update on multiple lymphodepletions and the feasibility of this approach, which we think is a quite feasible approach.
Li Watsek (Biotech Equity Research VP)
Okay. Got it. Just one question on AFM24, the combination with atezolizumab. I mean, since you completed, I guess, the first cohort at 160 mg. I wonder if you can just comment a little bit on the safety side and have you observed anything unexpected there? Also, can you remind us what was the sort of therapeutic range in a combination setting?
Andreas Harstrick (Chief Medical Officer)
As we said, we have completed the 160 mg cohort with standard dose of atezolizumab. We did not see a dose-limiting toxicity, which allowed us to escalate up to the 480 mg. As we said, we will provide a much more granular data update towards the end of the year, which will include also safety profile.
Li Watsek (Biotech Equity Research VP)
Okay. I guess it's just last one on AFM28. In terms of the phase I study, can you just sort of discuss the design of the dose escalation, and then can you just walk us through the timeline here, and when we might see the data from the dose escalation portion, and what would be the plan, I guess, after the phase I?
Andreas Harstrick (Chief Medical Officer)
We've made the strategic decision to focus initially on areas outside of the U.S., as we have guided in our document. We expect that patient enrollment will start first half of next year, first half of 2023. As you know, for dose escalation studies, it's always difficult to predict. It is a dose escalation study that aims to identify the recommended phase II dose and the pharmacodynamically active dose, and then as soon as possible. Beyond that, our intention is to look at AFM28 as a monotherapy for patients with refractory AML, but also to combine with allogeneic NK cells as soon as possible. This will be a two-pronged approach for the AML treatment.
Li Watsek (Biotech Equity Research VP)
Okay. Got it. Thank you.
Operator (participant)
Thank you. We have our next question from Bradley Canino with Stifel.
Speaker 10
Hey, this is Bijan for Brad Canino. Thanks for taking our question. For the upcoming FDA meeting on the AFM13 and NK-cell combo, what are some of the key points you intend to communicate with the agency? Are there other steps that need to be finalized prior to a pivotal trial start?
Adi Hoess (CEO)
Andreas, do you wanna take that?
Andreas Harstrick (Chief Medical Officer)
Yeah, I can start, and you can also chime in if needed. As we have seen this unprecedented activity of NK cells in combination with AFM13, especially in Hodgkin lymphoma patients, our intention is to bring this treatment to patients and then make it broadly available as soon as possible. Our focus in discussions with the FDA will really be to align or agree on a development path that ideally would enable the most expedited or the fastest approval of an NK cell AFM13 combination. Which kind of trial would lead us there and what the FDA's expectations would be.
We believe, given the very high activity and the unmet medical need of these refractory patients, this should be a development path, using the accelerated approval process. This will be some of the questions that we will address with FDA.
Speaker 10
Okay. Perfect. Are there other steps that need to be finalized, prior to a pivotal trial start, manufacturing, et cetera?
Adi Hoess (CEO)
Well, in terms of manufacturing, I think we have outlined this through the earlier questions that we've been able to accumulate a lot of know-how within Affimed and understanding what we believe the requirements are for manufacturing. We have identified companies that can provide satisfying answers.
As soon as we are ready to disclose, likely when we are either after the meeting, we can then provide the granularity. It remains at the moment a question to be addressed. Let me put it this way, a question to be addressed. Nevertheless, we are basically learning in the past months and quarters that there is substantial quality in terms of NK cell manufacturing available. We've been testing the cells, our internal engagers and generate the confidence. We've released all this preclinical data already at past conferences or presentations that show that there is substantial activity with cryopreserved cells. We can freeze these cells when loaded with AFM13, and then after thawing, they are active.
There is a good part of work that we had to invest in order to make sure that the NK cells display the respective activity. In addition, we have learned from clinical data presented by others that there are different NK cells that seem to produce very similar clinical efficacy, in particular in non-Hodgkin lymphoma, either as CAR-CD19 or as cells combined with rituximab. There is a lot of additional information in the meantime available that hasn't been available a year ago and just accumulated in the past months.
That's how we have been basically learning and creating a confidence on our part so that it is now the right time to bring the partner and Affimed together and move forward with a discussion and a meeting with FDA. That's currently prepared, as we said.
Speaker 11
Got it. Thanks for taking the question.
Operator (participant)
We have our next question from Yale Jen with Laidlaw and Company.
Yale Jen (Senior Managing Director and Senior Biotech Analyst)
Good morning, and thanks for taking the questions. First, from the AFM13 and the NK combos. For the 24 patients so far you treated, could you give us a breakdown in terms of the tumor types at this moment?
Adi Hoess (CEO)
Andreas?
Andreas Harstrick (Chief Medical Officer)
Yeah. The majority is still Hodgkin lymphoma. We cannot give detailed numbers as this will be part of the disclosure. As you have seen, the initial 11 patients were already Hodgkin lymphoma. We are actively also recruiting non-Hodgkin lymphoma patients now.
Yale Jen (Senior Managing Director and Senior Biotech Analyst)
Okay, great. That's very helpful. One more question here is to follow the previous one, in terms of the AFM13 monotherapy in the U.S., so what the bar of efficacy and the DOR will be and what could be the minimum performance in your opinion that will provide a greater commercial viability?
Adi Hoess (CEO)
Andreas, you wanna speculate on this?
Andreas Harstrick (Chief Medical Officer)
No. I only can reiterate what I said. In terms of regulatory, we have a couple of precedents with response rates in the high 20%, 27%-28%. Duration of responses around the eight months. This is our internal benchmark. Then we will have discussions with FDA. I definitely cannot comment on any commercial aspects. What we know though is that this is a patient population of very high unmet medical needs. Treatment options are very, very limited. I think it would offer a treatment option for patients who basically are threatened by death immediately.
Yale Jen (Senior Managing Director and Senior Biotech Analyst)
Okay, great. That's helpful. Thanks for the color and good luck.
Operator (participant)
We have our next question from Zhiqiang Shu with Berenberg.
Zhiqiang Shu (Head of Healthcare Research and Senior Biotech Analyst)
Great, thank you. I wanted to ask about the 11 additional patients that have been treated in the AFM13 NK cell combo post AACR. I wonder if you're willing to provide a bit of detail in terms of the efficacy and safety there. Also including this one particular patient, I guess first patient, receiving four cycles. I wonder if you are willing to provide a bit more granularity around these progressions and responses here. Thank you.
Adi Hoess (CEO)
I'll hand over to Andreas in a minute, but obviously we remain very excited and are obviously very positive, not surprised, about this good number of recruitment that we were seeing here. You can also go into social media where people are reporting about their experiences with this therapy. There has been clearly a good amount of information that was spread so that patients have been brought onto such therapy since AACR. As we've said, we have now 11 additional patients that were recruited and treated as of end of July. This in our minds indicates how high of demand we really are seeing for this patient population.
Obviously regarding reporting data, we've been very focused on basically following the rules by the respective organizers in order to secure a prominent presentation slot. Andreas?
Andreas Harstrick (Chief Medical Officer)
Yeah. I cannot add significantly more. As we have said, we are expecting to have an update of the data in collaboration with our investigators from MD Anderson at a major scientific meeting towards the end of the year. Before that meeting, we cannot give any more detailed data on the new patients or on the ongoing patients beyond what we have already disclosed in our remarks.
Zhiqiang Shu (Head of Healthcare Research and Senior Biotech Analyst)
Okay. Thank you. Maybe just a follow-up on your business development strategy. Can you talk about, you know, some of the thoughts there, given you have, you know, quite a differentiated platform? Are you still looking to extend some of the partnerships in the near future, and what are the potential measures there? Thank you.
Adi Hoess (CEO)
Yeah. At this moment, I do not wanna comment specifically on business development. Foremost, we've been focusing obviously on the execution of our three programs, that's where we've really invested our most emphasis. We have, and we've said, we've been and are receiving continuous inbound requests. We are valuing this against what we want to achieve on ourselves before we enter partnerships. These are ongoing dialogues and we pay attention to this. At the same time, in particular with AFM13 and AFM24, we've been progressing in the clinic to now be able to present updates in this second half, but also continuously. We're generating value by progressing the programs. We have.
We're well-funded indeed, so can proceed with the strategy until we may decide to have identified an appropriate partner. It remains at the moment, I wanna remain here very vague. Also, I should mention that there is a good number of interest in partnering up with Affimed on some of the specific programs in our earlier pipeline.
Zhiqiang Shu (Head of Healthcare Research and Senior Biotech Analyst)
Great. Thank you.