Q1 2023 Affimed N.V. Earnings Call
Good day everyone and welcome to Affimeds 1st quarter 2023 earnings and corporate update call.
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I would now like to introduce your host for today's call Alex Pudukidis, head of investor relations at Affimed. Please go ahead.
Thank you Liz, and thank you all for joining us today for our first quarter, 2023 update call. Before we begin, I'd like to remind everyone that we issued two relevant press releases earlier today, which can be found on the Investor Relations section of our website. Thank you.
On the call today, we have the members of our management team, including Adi Hurst, our chief executive officer, Andreas Horstrick, our chief medical officer, Arn Chatellius, our chief scientific officer, Wolfgang Fischer, our chief operating officer, Denise Mueller, our chief business officer, and Angus Smith, our chief financial officer.
The team will be available for Q&A after the preparatory 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 the order-looking statements publicly or to update the 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 subjects to risk 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 and of Violence with the SEC, and those identified under the section entitled Forward-looking Statements.
and the press release that we issued today and filed with the SEC. With that, I'd like to turn the call over to Ari. Ari? Ari?
Thank you, Alex, and good morning, everybody. Thanks for joining our call today.
I'll start with reviewing key highlights and as Alex has already mentioned, I'm very pleased to report that we continue to make progress on our key priorities across the pipeline.
As you can see now on slide 5, first, we are extremely excited to announce the FDA clearance of our investigational new drug application for the combination of AFM13 with AB101.
And we will call this study Luminize 203.
This is a significant achievement for our company as it enables us to move forward with a phase to study of this promising therapy.
I'd like to thank all colleagues at Affinment and Artiba who worked diligently in the past few months to make this possible.
This treatment now will build on the findings that we have generated in the AFM13104 study of AFM13 in combination with co-plugged the RISE natural killer cells.
data, which was presented by Dr. Iago Nieto from MD Anderson Cancer Center at the ASH conference back in 2022.
Across our organization, we're committed to advancing the development of this therapy as fast as we can.
The efficient and quick execution of this trial, assessing the combination therapy of AFM13 and AV101 is a key focus for our company.
Will Confucian achieve operating officer will go into the details of the study design?
and timing late in the call.
And Grace Hartstreet, our Chief Medical Officer, will update you on the rest of our clinical programs.
with eachFR expressing solid tumors. We now plan to present interim data from the Monotherapy expansion cohort at the upcoming ask committee on June 3. Specifically, we will be presenting data from the non-small and lung cancer cohort, which has been accepted for post-apresentation, and data from the core rectal cancer cohort, which has been accepted for online publication. The data will include about 15 patients from each core. The full text of the abstracts will be published later this week.
The data in the NSCLC poster will include data from a later update. We plan to host a call with the financial community to review the monotherapy data in more detail, as well as provide a strategic update on the AFM24 program. The virtual event will be held on Saturday, June 3. Details of the call will be included in our abstract release on Thursday. Finally, we hope to see you there.
So it's one study of 828 monotherapy is proceeding quite rapidly. We're pleased to announce that we're already.
that the first dose court has already been cleared. And the study is now actively recruiting patients in the second dose court. Which means all our pipeline programs have significant potential to address unmet medical needs and improve outcomes for a variety of hematologic and solid tumor indications. With this, we are quite uniquely positioned to drive share of the value in the near term.
Before I hand over the call to Wolfgang, I'd like to mention that considering the current market conditions,
Affirmate has in had to make a difficult decision to control our operating expenses by reorganizing our company.
to focus our efforts primarily on our peer-need programs. As a result of the reorganization, we have reduced our full-time equivalent headcount by approximately 25%.
We took extra care to ensure that this reorganization will not impact the development of our three clinical programs. Thank you.
And we believe we are well positioned to meet key data milestones for all three programs within the next 3 to 15 months.
This now includes data from AES-113 in combination with AB101.
in AML as we continue to make progress with the dose escalation.
And with that, let me turn over the call to Wolfgang, who will provide additional insights on the progress we're making in our pipeline. Wolfgang.
Thank you. Good morning. Everybody.
As Adi mentioned, we now have the IND clearance from the FDA to take AFM13 into a phase 2 study in combination with the AB101 and KSAR from Ativa. This study will build on data from the AFM13-104 study, which we reported at ASH in December 2022.
Very briefly, as shown on slide seven, at ash we reported data from the phase one, two study of 1813 combined with co-platé arrest and case trials in patients with relapse refactory and CD-30 positive lymphomas.
Data from the study showed a 94% objective response rates and a complete response rate of 71% in 35 heavenly pre-treated, CVSERD positive, HOTS from lymphoma and non-hotch from lymphoma patients treated at the recommended face to dose.
63% of the patients treated at the recommended phase 2 dose with at least 6 months follow-up after the initial infusion remained in complete response for at least 6 months.
In addition, the treatment was well tolerated with no cases of.
So I had a kind of release syndrome.
Immune effect associated neuro toxicity or graft versus host disease observed.
Since we disclosed the data from the AFM 13-104 study, we have had conversations with treating physicians and we know that there is a lot of interest in the medical community about the possibility of having such treatment available to patients.
In the past, we have also shared with you information about why we are confident in the combination of AFM 13 with AB 101 as outlined on slide eight.
We believe Antivas AB 101 and KSA has all key features that will allow for similar clinical results as those we saw with the combination of AFM13 with the MD Anderson and KSA. And very importantly,
It meets critical commercial requirements.
A new IND is for a face-to-cleanical study to investigate AFM-13 in combination with AB 101 from a team in patients with relapsed Resecretary Hodgkin lymphoma who have exhausted all standards of curved face-to-clean optical verses from vinicular praline organ too.
IND is for a face-to-cleanical study to investigate AFM 13 in combination with AB 101 from ATVA in patients with relapsed Resecretary Hodgkin lymphoma who have exhausted all standards of care therapy including chemotherapy.
and took some of the little tin.
and the PD-1 checkpoint inhibitor. As is shown on slide 9, the primary endpoint of the study are to assess the antitumor activity by objective response rate, including complete responses and partial responses.
Secondary end points of the studies are to assess efficacy and mobility of response.
Plays the intolerability, as well as immunotronicity of the combination therapy.
Now on slide 10, we introduce the design of the clinical study, which as I mentioned before, will be called Luminize 203.
The study will begin with a safety running space. During this phase, we will evaluate different combination doses of AB1 and 1 and AFM13 in four cohorts of six patients each.
dose of 2 billion AB101 cells administered weekly combined with AFN 13.
2 billion AB101 cells administered weekly combined with AFN 13, 200 million weekly.
Cohort 2 will be exactly the same, except that the AFM 13 dose will be 300 milligrams. Cohort 3, there we will evaluate the dosing regimen of AB 101 of 4 billion cells.
in week one, followed by two weekly doses of 2 billion cells, in each case combined with 200 milligram AFM13. And finally, cohort four will be the same as cohort three, except that we will administer AFM13 300 milligram weekly.
one followed by two weekly doses of two billion cells. In each case, combine with 200 milligram AFN 13. And finally, cohort four will be the same as cohort three, except that we will administer AFN 13 300 milligram weeks. Ambassadors.
We will evaluate the safety and preliminary assigned to the dosing regimen.
with the goal of selecting two dosing regimens for the dose optimization phase, which follows assignment two stage two time.
The study has then the potential to continue with one or both cohorts from the optimization phase into the expansion phase.
The trial will enroll up to 100 then.
The trial will enroll up to 140.
134 patients.
and currently all our clinical sites are located in the United States.
As you can see, there is also an exploratory cohort with T-D30 positive PTCL patient.
which will include another additional 20 patients.
On slide 11, we show the treatment regimen.
In Luminize 203, patients will be treated with lymphodepleting doses of glutarabine, 30 mg per square meter per day, and cyclophosphamide, 300 mg per square meter per day, prior to the first AFM13 AB101 dosing.
This dose and schedule of lymphodigrating chemotherapy is based on other cell therapy studies that have demonstrated the safety and the sickness effectiveness of this regimen, including our own study AFM 13104.
As you can see on the slide, one treatment cycle will consist of three weekly co-administered doses of AFM13 and AV101, followed by three weekly doses of AFM13 monotherapies. Up to three cycles of treatment management.
Looking ahead as outlined on slide 12.
We are very focused to get the study up and running in Q3 2023.
During the IND process, we requested feedback from the FDA on the suitability of the study to support and accelerate the approval in Houchpin, the POMA.
application in the US. Finally, we expect to be able to share data from the safety run-in phase during the first half of 2024.
As a final note of this discussion about the combination of AFN 13 with AB 101, many of you have asked that questions about when ATVA plans to share data from AB 101 in B-cell Informa.
We wanted to bring to your attention that our TVI is planning on presenting data from the AB 101 retooks him up combination study in a post-presentation at ASCO on June 5th. Now I'll hand over the call to Andreas to discuss the updates for our other clinical programs.
Andrea.
Thank you Wolfgang and also welcome from my side to everyone on the call.
Let's now move to AFM24.
And as we show in slide 13, at ESCO, Affymet will present initial data from two expansion cohorts of the Mono Serapis study of our EGFR targeting in Nate Sellen-Gager AFM24.
As mentioned by Adi, we have been accepted to present interim results from the EGFR mutant non-small cell lung cancer cohort in a poster presentation.
And in addition, interim results from the Collirector Cancer cohort have been accepted for online publication.
As you will be aware full abstracts for Asco and for both of our cohorts.
will become available on May 25th. So for today we are limited in what we can share with you.
However, what we can tell you is that the data reported on May 25 in the abstracts.
We'll have a cut-off date of December 2022. At ASCO for the non-smotor lung cancer cohort, we will share updated data with a significantly later cut-off date. Specifically, we will present data from 15 patients.
from each of Sinon-Small-Selon Cancer and the Colorectal Cancer Co-Horps. As Adi mentioned, we are also planning to host the call with members of the financial community to discuss the data.
and to review our AFM24 strategy going forward. Our second AFM24 study, the combination of AFM24 with a Tizaliza map,
We are continuing to treat patients with non-small cell lung cancer, EGFR-wide type.
Gastric and Gastroezifagio Junction Adinucarcinoma.
and Penn Criatic Hepatocelular and Beleri tract cancers in three separate cohorts.
The dose escalation portion of the study is complete and we have confirmed the 480 mg weekly dose of AFM24.
as you recommended Phase 2 dose.
Enrollment in the expansion cohorts is ongoing and the treatment continues to show a well-managed safety profile.
As shown, we plan to provide data from this ongoing study in the second half of 2023. The second combination study of AFM24 is investigating the combination of AFM24 with SNK01, which
The ex vivo expanded and activated autologous NK cell product from NKGen Biotech. Here both agents are given weekly to patients with non-small cell lung cancer, EGFR wild type, Th20PX.
Squamous cell carcinum or seahead and neck, and colorectal cancer.
We continue to enroll patients in the dose escalation phase of the trial.
and expect to have this completed within 2023.
Also for this trial, we plan to provide data in the second half of 2023. Now moving to AFM 28 on slide 15.
We show the exciting progress that we were able to make with our ICE designed to bring a new immunosiraputic approach to patients with CD123 positive, myelotelic malignancies which include acute myelotelochemia and myelodisplastic syndrome. I am very happy to be able to make a new immunosiraputic approach to patients with CD123 positive.
In our Phase 1 study, we treated the first patient in March.
And since then we have been able to complete the first dose cohort of 25 milligrams once weekly.
without encountering those limiting toxicity.
This has allowed us to open the second dose cohort at 50 milligrams weekly, in which we are currently actively recruiting patients. Given the aggressive nature of this disease and the need for viable treatment options, we are working diligently to bring this treatment option
to refractory and relapse AML patients as quickly as possible. With this short summary, I will turn the call over now to Angus to update you on the quarterly financial numbers. Angus, please.
AML patients as quickly as possible. With this short summary, I will turn the call over now to Angus to update you on the quarterly financial numbers. Angus, please. Thank you, Andrea.
Balance sheet and income state highlights are shown on slide 17 and 18 of the presentation.
As a quick reminder, Apping Met's consolidated financial statements have been prepared in accordance with IFR requests as issued by the International Accounting Standard Board for IASB.
The consolidated financial statements are prepared in Euros, which is the company's functional and presentation currency.
Therefore, all members that I will present on this call, unless otherwise noted, will be in Euros.
As of March 31st, 2023, Cash and Cash Equivalence told 155.8 million euros compared to 192.3 million euros on December 31st, 2022. Based on our current operating plan of assumptions, we anticipate that our Cash and Cash Equivalence will support operations into 2025.
NetCash used an operating activities for the quarter ended March 31, 2023, with 33.2 million euros compared to 28.4 million euros for the same period in 2022.
Plot of revenue for the quarter ended March 31st, 2023 was 4.5 million euros compared with 8 million euros for the quarter ended March 31st.
the quarter ended March 31st, 2023 was 4.5 million euros compared with 8 million euros for the year for the quarter ended March 31st, 2022.
Revenue predominantly relates to the Genentech and Roy Vance collaborations. Research and development expenses for the quarter ended March 31, 2023, increased by 60.7% from 18.4 million for the same period in 2022 to 29.5 million in 2023. The increase was primarily due to higher expenses associated with the development of
March 31, 2022 to 6.9 million euros in the quarter ended March 31, 2023.
An increase in personnel costs were offset by a decline in legal consulting and insurance expenses.
to costs of about half a million euros in the quarter ended March 31st, 2023. As a reminder, net finance income or costs are largely due to foreign exchange gains or losses related to assets that are denominated in U.S. Wallars as a result of currency fluctuations between the U.S. dollar and the euro during the year. Net loss for the quarter ended March 31st, 2023 was 32 million euros.
with 21 cents per common share. I'm going to go within that loss of 16.7 million euros or 14 cents per common share for the quarter ended March 31st, 2022.
The weighted number of common chairs outstanding for the quarter-ended Mark 31st, 2023, was 149.3 million. Additional information regarding these results is included in the notes of the consolidated financial statements as of Mark 31st, 2023, which will be included in the after-match filings with the SEC.
I'll now turn the call back to Adi proposing remarks. Adi. Thanks a lot, Angus. Now moving to slide 19, we show a snapshot of all our programs.
And we're very excited on behalf of patients that could benefit from the combination treatment of A from certain with AB 101. And we're now looking forward to getting the study started and bringing you updates as we make the progress.
We also are looking forward to our call with you on June 3. To discuss the findings from the Non-Smolter Lankanzer and Coloregicanzer Studies.
during which we are also planning to update you on our other plans for 24, for April 24, going forward.
And as you've heard, we are indeed quite ecloited about the progress we are making with AFM 28.
in AML, which we believe has a huge potential, as we mentioned in the past, that encasals can play a major role in AML from 28, has a very pronounced activity redirecting in K-SOL.
We're also thankful for the support and efforts of our employees. We're full together to move things forward.
It is through that dedication and the support from you and the patients and their families that gives us inspiration to continue our work of bringing these life-saving therapies.
It is through that dedication and the support from you and the patients and their families that gives us inspiration to continue our work of bringing these lifesaving therapies to the market.
We are now ready to take questions and the hunt back to the operator. As a reminder, if you'd like to ask a question at this time, please press star 1-1 on your telephone and wait for your name to be announced. To withdraw your question, please press star 1-1 again.
Our first question comes from a line of Mori Raycroft with Jeffries.
More ear line is now open. Hi, thanks for taking my questions. Question on the Luminize Study, presumably the Simon's use stage design part of the study is open label. Just wanted to clarify that. And then also wondering what is the bar for success on overall response rate and duration of
Whenever they are in need,
Yeah, thanks, Angus.
Yeah, thanks, Angus. Hi, Marie.
As you can see on slide number 10, the dose optimization, right, we have two cohorts selected from the safety run-in, 13 patients per cohort, and each of these cohorts will follow assignments they should decide. So that means we are evaluating each of these.
Forward separately, right? So if utility, whether to move forward, yes or no.
right? So if utility, whether to move forward, yes or no. That's that's number one.
The other question was the bar success, but based on the data we have generated with AFM 13104, we believe that the bar or that we can achieve very high response rates, very similar to what we have seen.
in the 104 study.
And the third question I do not remember, could you please repeat?
If you're saying anything additional I'm powering for the study.
If you're saying anything additional I'm powering for the study.
And today, do you want to take that question regarding the power of the credit?
Yeah, I can take this question. As Wolfgang has said, and I think it's also depicted on the slide, the second part of the study which starts with two doses selected from the initial four cohorts, and then the option to continue
basically into the expansion consists of two separately powered Simon II stage cohorts. So there is no direct comparison on a statistical level between the different cohorts. And on the totality of the data, we can decide to either move one or two cohorts.
until the final number of 55 patients per cohort. Or this was something that specifically came out of our discussions with FDA, and I think it's also in line with those FDA's attempt to have more data available on those optimization and the effect of different doses on the outcome. So again, these two arms are separate, over two months.
running data or would that be later on? And have you, can you say if you've spoken with FDA at all about the feasibility of doing a randomized study as opposed to a single armed study?
Oh yeah, we'll pass and go ahead, yeah.
Oh yeah, we'll both go ahead. Yeah.
So we have defined that study would be intent for an accelerated approval, very clear, right? And also following also the draft guidance from FDA from March 2023, we are still very clearly says that single-arm study is still feasible in certain centers. So we asked the FDA for that feedback.
And the FDA came back to us and recommended that we continue that discussion in a separate meeting with them. So basically they recommended while starting the study reaching out to them for further discussions.
During these interactions with the FDA, the FDA did not provide us specific.
specific guidance or feedback regarding their concerns.
Got it. OK, makes sense. Thanks for taking my questions. Our next question comes from a line of Lee Watzek with Cantor Fitzgerald.
Hey guys, thank you for taking our questions. Maybe just follow up on, I guess, the registration and application understanding that, you know, you're still in a process of...
that with an agency, but I guess can give us a sense of what kind of different scenarios that you're preparing for here.
I mean, we are in constant.
We are in constant contact with our project manager at FDA.
constant contact with our project manager at FDA, and we'll determine the next steps.
Once agreed with the timelines, we will give provide further guidance. We also believe that it's currently too premature to discuss or to speculate what is the FDA's position and what are different scenarios.
Okay, got it. And then just for the safety run in proportion, I guess do you need to discuss with the agency before you proceed to the optimization service portion or it will be pretty similar.
And I guess for the City Roaming portion, how long is the follow up? So the first one, you want to first it? Yes, sorry, Eddie. The first question, right? These patients.
treated as outlined on the slide we have provided, I guess it's slide number 11. Also, these patients can receive up to three cycles.
The assessment for selecting two dose cohorts moving forward into the optimization phase.
will happen after the first assessment.
And the first question was whether we need to go to FDA before moving forward, note the FDA provided full commitment to that study.
All right, thanks.
Our next question comes from a line of three creeper Devarakonda with Truist Securities.
Thank you so much guys for taking my question and congrats on getting the IND cleared. Quickly, what else needs to be done in order for you guys to get the trial going? You set the water, you should be able to get it going. And.
based on the trial enrollment that you saw with your previous partnership with MD Anderson. How confident are you that we'll have enrollment and we'll be able to see data from the run in patients at about 24 patients in first half? And...
Is there any likelihood that we could see, we could also see enrollment in stage two by then? Not data, but at least enrollment. Thank you.
Again, welcome. Yeah. So first question, we are preparing for first patients.
First patient in Q3 2023, but then we are fully on track on that. So we are interacting with the CROs, we are interacting with the site, et cetera, et cetera. So that's all fine and on track for Q3 2023.
Regarding the first data, yes, we plan to provide a first data from the safety run-in, so from the 24 patients in age 1, 2024.
already begin in stage two of the trial as well.
I mean, we will start with stage two of the trial, so with the optimization phase, as soon as we have finished basically the safety run in right after the first assessment, as I said before, because that's the basis for moving forward.
And as soon as we have completed that, we will start with the stage two. When that exactly will be, I can't say. Okay, thank you. Let's have a good.
Our next question comes from a line of Brad Kinino with Stevele.
Hi, thanks for the updates. I'm looking at slide 10 here for the dose expansion portion where it says you'll select one or two cohorts depending on the interim clinical data. I'm wondering, can you comment on what length of follow-up will be required for the interim data to make that decision to move into the pivotal period?
Hi, thanks for the updates. I'm looking at slide 10 here for the dose expansion portion where it says you'll select one or two cohorts, depending on the interim clinical data. I'm wondering, can you comment on what length of follow-up will be required for the interim data to make that decision to move into the pivotal period? It what design screen will always be required?
Welcome again. After the dose optimization, the patient will be followed up for two treatment cycles. After these two treatment cycles, the decision will be made, the interim analysis will be made, and then the decision based on the Simon II stage, she signed to move forward or not to move forward. After two treatment cycles, two assessments. Okay. Thank you. And then as you continue the FDA discussions, can you help us understand how much your partner is included in these? You know, I'm particularly thinking about how much buy and they might have if one of the decisions of being to run a concurrent confirmatory study along with this single arm study. Thank you.
Okay. Yeah. So after the dose optimization, the patient will be followed up for two treatment cycles. And after these two treatment cycles, right, the decision will be made, the interim analysis will be made, and then the decision based on the Simon II stage is signed to move forward or not to move forward. So after two treatment cycles, two assessments. Okay. Thank you. And then as you continue the FDA discussions, can you help us understand how much your partner is included in these? You know, I'm particularly on thinking about how much buy and they might have if one of the decisions of being to run a concurrent confirmatory study along with this single arm study. Thank you. Yeah.
So I take that at least the first part and then I give it to you for the second part. The partnering with ATIVA is going very well. It's a very nice and very good collaboration on a team level, on a trans-deer-in-comer-T level.
Right, and we are all aligned in our interactions with the FDA. We aligned before we discussed, right, and have a common pass forward. Right, so that's going really well. Regarding the confirmatory study, right, and their commitment, I will hand over to Adi, please. Yeah, contractually, if you know this is a shared study.
in terms of costs and we have not yet started the details of this discussion as we fully we're fully focused on getting the I&D cleared and obviously our team has played a major role in depending the I&D and input into the study design so as we're now
Through with the IND clearance, and can start the study, we will now take up and move to the next steps on what kind of contemporary studies we were contemplating. We have already mentioned in the past that we have obviously a number of options in...
an art can informer where we can place it, but we also focus in terms of moving forward with the PTCL at least initially based on the cohort findings that are on the findings within the 28th patient cohort. That's our plans here. Appreciate the comments.
Our next question comes in the line of Dana Greybosh with SBB Securities.
Hi, this is Rebecca on line for Dana.
The questions that we have are surrounding ASCO in particular, especially in regards to Artiva. What are you looking for for this first disclosure in the clinical data for Artiva given that this product is used for the...
move a nice two or three trial as opposed to that at the end of some products of previous data. And then what are we looking for in the ASM-24 model of their D data in CSC-M and C-L-C, that give us confidence for future readouts in second half, 23 and the combination with NK cells and or PDL one.
Yeah, thanks for the question on hand over to Undress, please. Yeah, so it's a difficult to answer question because it relates basically in all parts to the data that will be published at ASCO.
As you know, for ATIVA, the ATIVA has an ongoing study that evaluates both of the AB 101 cells as a single product, so without targeting agent. And here they are looking at a couple of different dose levels in patients who has bee-sound the lignancies.
of their study. Again, given that this is an upcoming ASCO presentation, we cannot go into more details as all of the, especially the updated newer data are under ASCO embargo.
For AFN24 again we will show updated data for the patients with EGF arm mutants, non-small cell lung cancer treated with a single agent AFN24, we will also have an online
publication for the Coalerectal Cancer cohort. Again, those will have updated data compared to the abstracts that come available, become available later this week. And as we said, after our poster presentation, we will also...
host an investor event to discuss the whatever comprehensive discussion of the AFM 24 strategy. Of course, taking into account new data that we will show at ASCO.
think until then I unfortunately cannot share more details with you.
Just a short follow up, we've heard that different companies are permitted to provide updated data after the abstracts are released if the data are different. Then what was written in the abstract is that something you can look for from the athlete? Yeah, can.
Oh, he maybe I can take that one. So thank you for the question. It's something we want to say looks very closely at the ASCO is unique in this regard. Ultimately, since we have a poster presentation at ASCO, out of respect for our investigator who will be at the poster.
Our decision was to provide the updated data at ASCO itself on June 3rd. And as Adi and Andreas mentioned, to the host and investor call subsequent to the post or discussion to provide further updates on A at the point for us. So.
That was the decision, that's kind of what one of your decision to wait until June 3rd. And as was mentioned, the abstracts with the December cut-up date will be published on Thursday.
That was the decision, that's kind of what one into our decision to wait until June 3rd. And as was mentioned, the abstracts with the December cut-up date will be published on Thursday. Thank you so much.
Our next question comes in line of Yale Gen with lead law. Good morning and thanks for taking the questions.
Good morning. Good morning. Morning. Oh, you. Sorry. My first question is that you guys mentioned that the press release that you're going to have.
We couldn't go data presented at the ICML. My question is that what should we anticipate from that data release? And do you show anything comparison to the co-bluet cell derived in case they are as well?
Andrea, you want to take the question, please. When it's relating to pricking, I think, aren't what probably be the right person to respond.
Okay, sorry. I think I can take a question, Gail. Very nice to. Thanks for your question. So you will have noticed we have not given any specifics because we want to also respect the embargo for this conference. But as you can assume, you know, we will show frequently the combination of the products.
and some of that we had actually previously shown.
also some investor conferences. So we will show the pre-climical basis for moving into the comics. So you can expect that there's a synergistic activity to be shown. But I cannot share more specific stuff that will be shared at the end.
So we will show the pre-climical basis for moving into the comics, so you can expect that there's synergistic activity to be shown. But I cannot share more specifics that will be shared at the conference, I'm sure you'll understand.
Sure, not problem and thanks for that. And maybe just one more housekeeping questions. I also in the press release indicated that the Junentech collaboration, at least for the time being, seems completed, you handed out the products. So just from modeling purpose.
Should we anticipate the revenue be slightly lower going forward as you at least assume there's only one collaboration partner at the moment until otherwise?
Yeah, yeah, I can take that. So.
As you mentioned, right, with the work that we were responsible for under the Genentech collaboration has now been completed and the targets that we were developing on their behalf have been handed over to Genentech. So that's good news on that front.
As you know, we have been recognizing revenue associated with the up-front payments we received under that collaboration over time based on a percentage of completion basis. So naturally we have now recognized the bulk of the revenue from the up-front payments we received. There will be no more than that. So there is a lot of work to be done. Thank you.
A small tail on that for certain upfront payments that are recognized on a time basis. But as we've disclosed in our financial statements, you can certainly assume that the revenue will be recognizing, which is non-cash, by the way, will be lower than what we've recognized in previous quarters as a result of now the completion of our work under those projects.
The same will hold true eventually for GoiMant as we have moved forward towards completion of the work we have there and now recognize the large proportion of the of the up front payments we received under that collaboration. An easy way to sort of tell what what may be coming in in in the next 12 months is to look at
and congrats for the art of progress.
Our next question comes from the line of G-Ting Chu with Bannonberg.
Thank you for taking my question. This is Andy on for Z. Regarding your face to trial, it looks like you're doing four cohorts to doses for AFM 13 to doses for NK South therapy. Can you please remind us how were those selected and which level of confidence behind those doses chosen?
And my other question is regarding the restructuring, 25% of your employee, how is that going to affect your operating expenses going forward if you can provide some guidance please? Thank you.
Thanks for asking. I will hand over the second question.
to Angus and then move back to both Angus. Sure. So I mean looking at the reorganization, you know, on a doughnut in the vacuum, I mean the reduction in head count costs that we would expect on an annualized basis is in the range of about 5 million euros.
Obviously, that won't be recognized immediately. There are notice periods and severance obligations that will come with that. But we do expect to begin to recognize savings this year, and then next year start to see that fiscal impact on an annualized basis.
So on its own, the reorganization will have, it's roughly a 5 million annualized impact. And operating expenses that'll be spread across R&D and GNA, and then obviously within that context, there are other investments that, you know, for primarily in the early stage of life.
as mentioned on the genetic and relevant collaborations now winding down with those molecules being handed over to our partners. So operating expenses beyond the reorganization should start to come down as we go through the rest of this year. And now moving back to the question. Okay, the question, the rest question was with those selection.
for the safety running cohort. But let's start with AFN 13. And for AFN 13, we have a recommended phase two dose of 200 milli-crime flat, which has been used also in the PTCL trial, but which we also used in the AFN 13 104 trial. And...
We decided also to evaluate the higher dose, namely 300 milligram after discussion and feedback from the FDA. And this decision is driven basically by the fact that when we add additional and case cells that we are providing meaningful higher number of CD16A binding size and therefore higher doses of AFM13 may be needed to optimize receptor or cure principle.
This has been the reason for the 200 milligram and the higher dose of 300 milligram. When we move to the AB101, these two doses have been selected, of course, after discussion with the colleagues from Ateiva.
And these are based on initial data from their ongoing phase one study, which Andreas mentioned earlier. The initial data from this study will present to that S.O.S. he said, and therefore, I'll underembarate that time. Therefore, we cannot further comment on this. Thank you.
These are based on initial data from the ongoing phase one study, which I'm clear to mentioned mentioned earlier the initial data from this study will presented that as he said, and therefore are under embargo at that time. Therefore, we cannot further comment on this. Does that answer your question?
Yes, thank you. Congratulations again. Thanks. Thank you. Our next question comes from a line of Slyambakula Ramakant with HC Wayne, right?
Thank you. This is R.K. from HCV, Enlight. So most of my questions have been answered. Just a wanted to understand how will you do this history within hospts.
On air from 28 and see what stuff that you can provide in terms of how the phase one studies currently enrolling and should we expect any data in 2023.
Andrea, you want to take that, please? Yeah, so the study is, I would say, running very well. As I said, we only started.
In March to recruit first patients, we have already completed the first dose cohort, which were two patients. However, these patients are required to receive four infusions of AFN 28 to RB dose limiting toxicity valuable. So as we said, we don't have seen any DOTs, which allowed us to open the second cohort. So currently we are enrolling patients at the end.
Thank you. Thanks.
As a reminder, that is STAR-1-1 to ask a question. Our next question comes from Yanan Zhu with Wells Fargo Securities.
Thanks for taking the questions. Two quick ones on the Phase 2 trial.
One is, the first one is on the cadence of enrollment. Do you have to have safety evaluation for each patient or group of patients before enrolling the next group of patients within the same cohort?
Then another question is about the FDA regulatory discussion. Since you mentioned there seems to be additional discussion needed for determining the acclomerate approval path, I was wondering do you think that discussion
will require data from the Phase 2 trial. Yeah, thank you.
require data from the Phase 2 trial. Yeah, thank you. Worker.
Now to the first question, that's the study design. If you look at slide number 10, you can see that cohort 1 and 2 start in parallel, and then cohort 3 and 4 start in parallel.
What we do, the first patient of each cohort will go first and then there is a staggering and we wait seven days before we start with the second patient. So there is for the first patient there is a staggering of seven days.
Now, the second question, the additional discussion, whether it will require phase one data or not, currently we can't say, as I mentioned before, right, we are in close interaction with the FDA to determine next steps and then move that forward.
But we do not know and cannot speculate on the position of the FDA. And therefore we cannot comment on that.
currently because it's too premature. Thanks for understanding. Understood. Thanks for the answers.
Welcome. That concludes today's question and answer session.
This concludes today's conference call. Thank you for participating. You may now disconnect.