Affimed Q1 2023 Earnings Call Transcript

Quartr
Provided by Quartr
May 23, 2023

There are 15 speakers on the call.

Operator

Good day, everyone, and welcome to Affimed's First Quarter 2023 Earnings and Corporate Update Call. At this time, all participants are in a listen only mode. After the presentation, there will be a question and answer session. You will then hear an automated message advising your hand is raised. As a reminder, today's conference is being recorded.

Operator

I would now like to introduce your host for today's call, Alex Fudakidis, Head of Investor Relations at Affimed. Please go ahead.

Speaker 1

Thank you, Liz, and thank you all for joining us today for our Q1 2023 update call. Before we begin, I'd like to remind everyone that we issued 2 relevant press releases earlier today, which can be found on the Investor Relations section of our website. On the call today, we have the members of our management team, including Adi Hirsch, our Chief Executive Officer Andreas Haarstrek, our Chief Medical Officer Arndt Sutilius, 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 and A 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.

Speaker 1

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 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'd like to turn the call over to Adi. Adi?

Speaker 2

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,

Speaker 3

we

Speaker 2

are extremely excited to announce the FDA clearance of our investigational new drug for the combination of AFM13 with AB101. And we will call this study LUMINIS-two zero three. Indeed, this is a significant achievement for our company as it enables us to move forward with a Phase 2 study I'd like to thank all colleagues at Affimed and Artiva 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 AFM13-one hundred and four study of AFM13 in combination with cord blood derived natural killer cells. Data, which was presented by Doctor.

Speaker 2

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 The efficient and quick execution of this trial assessing the combination therapy of 13 and AB101 is a key focus for our company. Wolfgang Fischer, our Chief Operating Officer, We'll go into the details of the study design and timing later in the call. Andreas Hartstrek, our Chief Medical Officer, will update you 2nd, we have continued to advance AFM24 clinical studies towards key data milestone. AFM24 It's our novel innate cell engager targeting EGFR.

Speaker 2

We believe it has the potential to be a transformative therapy for many patients With EGFR expressing solid tumors. We now plan to present interim data from the monotherapy expansion cohort At the upcoming ASCO meeting on June 3. Specifically, we will be presenting data From the non small cell lung cancer cohort, which has been accepted for poster presentation and data from the colorectal cancer cohort, which has been accepted for online publication. The data will include about 15 patients from each cohort. The full text of the abstracts will be published later this week and will only include data as of the December 2022 The data in the NSCLC poster will include data from a later growth date.

Speaker 2

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, our Phase 1 study of A320 8 monotherapy is proceeding quite rapidly. We're pleased To announce that we already that the first dose cohort has already been cleared and the study is now actively Which means all our pipeline programs have Significant potential to address unmet medical needs and improve outcomes for a variety of hematologically and solid tumor indications.

Speaker 2

With this, we are uniquely quite uniquely positioned to drive shareholder value in the near term. Before now I hand over the call to Wolfgang, I'd like to mention that considering the current market conditions, Affimed has We had to make a difficult decision to control our operating expenses by reorganizing our company To focus our efforts primarily on our clinical 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 for all three programs within the next 3 to 15 months. This now includes data from AFM13 in combination with AV-one hundred and one.

Speaker 2

Data from all 3 AFM24 clinical studies and data from AFM28 mono 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?

Speaker 4

Thank you, Adi. Good morning, everybody. As Adi mentioned, we now have the IND clearance from the FDA to take AFM13 Into a Phase II study in combination with the AB-one hundred and one and K cells from Arkeva. This study will build on data From the AFM13104 study, which we reported at ASH in December 2022. Very briefly, as shown on Slide 7, at ASH, we reported data from the Phase III study of AFM13 combined with cord blood derived NK cells In patients with relapsedrefractory CD30 positive lymphomas.

Speaker 4

Data from the study showed A 94% objective response rate and a complete response rate of 71% in 35 heavily pretreated CD30 positive Hodgkin lymphoma and non Hodgkin lymphoma patients treated at the recommended Phase 2 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 cytokine release syndrome, immune effector cell associated neurotoxicity or graft versus host disease observed. Since we disclosed the data from the AFM13104 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 treatments available to patients. In the past, we have also shared with you information about why we are confident In the combination of AFM13 with AB101 as outlined on Slide 8.

Speaker 4

We believe Antiva's AB101 and K cell has all key features that will allow for similar clinical results At those, we start with the combination of AFM13 with the MD Anderson NK cell. And very importantly, It meets critical commercial requirements. A new IND It's for a Phase 2 clinical study to investigate AFM13 in combination with AB101 from Martiva In patients with relapsedrefractory Hodgkin lymphoma who have exhausted all standard of care therapy, including chemotherapy, brentuximab, leboutin and the PD-one checkpoint inhibitor. As is shown on Slide 9, the primary endpoint of the study To assess the antitumor activity by objective response rate, including complete responses and partial responses. Secondary endpoints of the studies are to assess efficacy, tolerability of response, Now on Slide 10, we introduce the design of the clinical study, which as Adi mentioned before, will be called Luminize-two zero three.

Speaker 4

The The study will begin with a safety running phase. During this phase, we will evaluate different combination doses of AB-one hundred and eleven And AFM13 in 4 cohorts of 6 patients each. Now let's go through the cohorts. Cohort 1 will evaluate a dose of 2,000,000,000 AV-one hundred and one cells administered weekly combined with AFM13, 200 milligram weekly. Cohort 2 will be exactly the same, except that the AFM13 dose will be 300 milligrams.

Speaker 4

Cohort 3, there we will evaluate the dosing regimen of AB101 of 4,000,000,000 cells In week 1, followed by 2 weekly doses of 2,000,000,000 cells, in each case combined with 200 milligram AFM13. And finally, Cohort 4 will be the same as Cohort 3, except that we will administer AFM13 300 milligram weekly. During the run-in phase, we will evaluate the safety and preliminary efficacy of these dosing regimen with the goal of selecting 2 dosing regimens for the dose optimization phase, which follows assignment 2 stage design. The study has then the potential to continue with 1 or both cohorts from the optimization phase Into the expansion phase. The trial will enroll up to 140 134 patients and currently all our clinical sites are located in the United States.

Speaker 4

As you can see, there is also an exploratory cohort with CD30 positive PTCL patients, which will include another additional 20 patients. On Slide 11, we show the treatment regimen. In Luminize-two zero three, patients will be treated with lymphodepleting doses of fludarabine, 30 milligram per square meter per day and cyclophosphamide, 300 milligram per square meter per day This dose and schedule of lymphodepleting chemotherapy It's based on other cell therapy studies that have demonstrated the safety and effectiveness of this regimen, including our own study AFM1310 As you can see on the slide, one treatment cycle will consist of 3 weekly co administered doses of AFM13 and AV101, followed by 3 weekly doses of AFM13 monotherapies. Up to 3 cycles of treatment may be eliminated. Looking ahead, as outlined on Slide 12, we are very focused to get the study up and running in Q3 2023.

Speaker 4

During the IND process, we requested feedback from the FDA on the suitability of the study to support an accelerated approval in Hodgkin lymphoma. At the recommendation of the FDA, in parallel to advancing the study, Affimed will have further discussions with the agency on the requirements for registration application in the U. S. Finally, we expect to be able to share data from the safety run-in phase As a final note of this discussion about the combination of AFM13 with AB101, Many of you have asked us questions about when Arteva plans to share data from AB101 in B cell lymphoma. We wanted to bring to your attention that Ateeva is planning on presenting data from the AV-one hundred and one rituximab combination study In the poster presentation at ASCO on June 5.

Speaker 4

Now, I'll hand over the call to Andreas to discuss the updates for our other clinical programs. Andreas?

Speaker 5

Yes. Thank you, Wolfgang, and also a welcome From my side to everyone on the call. Let's now move to AFM24. And as we show on Slide 13, At ASCO, Affimed will present initial data from 2 expansion cohorts of the monotherapy study of our EGFR targeting innate cell engager 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 The colorectal cancer cohort have been accepted for online publication.

Speaker 5

As you will be aware, full abstracts For ASCO and for both of our cohorts will become available on May 25. 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 cutoff date of December 2022. At ASCO for the non small cell lung cancer cohort, we will share updated data with a significantly later cutoff date. Specifically, we will present data from 15 patients from each of the non small cell lung cancer and the colorectal cancer cohorts.

Speaker 5

As Adi mentioned, we are also planning to host a 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 atezolizumab, We are continuing to treat patients with non small cell lung cancer, EGFR wild type, gastric and gastroesophageal The dose escalation portion of the study is complete and we have confirmed the 480 milligrams weekly dose of AFM24 For SCE 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 The second combination study of AFM24 Is investigating the combination of AFM24 with SNK-one, 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, squamous cell carcinoma of the head and neck and colorectal cancer.

Speaker 5

We continue to enroll patients in the dose escalation phase of the trial and expect to have this completed within Also for this trial, we plan to provide data in the second half of twenty twenty three. 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 immunotherapeutic approach Two patients with CD123 positive myeloid malignancies, which include acute myeloid leukemia In our Phase 1 study, we treated the first patient in March And since then, we have been able to complete the 1st dose cohort of 25 milligrams once weekly Without encountering dose limiting toxicity. This has allowed us to open the 2nd 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 relapsed AML patients as quickly as possible.

Speaker 5

With this short summary, I will turn the call over now to Angus to update you on the quarterly financial numbers. Angus, please?

Speaker 4

Thank you,

Speaker 6

Andreas. Balance sheet and income statement highlights are shown on Slide 17 and 18 of the presentation. As a quick reminder, Affimed's consolidated financial statements have been prepared in accordance with IFRS as issued by the International Accounting Standard Board The consolidated financial statements are prepared in euros, which is the company's functional and presentation currency. Therefore, all numbers that I will present on this call, unless otherwise noted, will be in euros. As of March 31, 2023, cash and cash equivalents totaled €155,800,000 compared to €190,300,000 on December 31, 2022.

Speaker 6

Based on our current operating plan and assumptions, we anticipate that our cash and cash equivalents will support operations into 2025. Net cash used in operating activities for the quarter ended March 31, 2023 was €33,200,000 Compared to €28,400,000 for the same period in 2022. Total revenue for the quarter ended March 31, 2023 was €4,500,000 compared with €8,000,000 for the year for the quarter ended March 31, 2022. Revenue predominantly relates to the Genentech and Royvant collaborations. Research and development expenses for the quarter ended March 31, 2023 increased By 60.7 percent from $18,400,000 for the same period in 2022 to $29,500,000 in 2023.

Speaker 6

The increase was primarily due to higher expenses associated with the development of AFM13 and AFM24, resulting from increased Procurement of clinical trial material, increased clinical trial costs and increased costs associated with other early stage programs and infrastructure. General and administrative expenses decreased 2.8 percent from €7,000,000 in the quarter ended March 31, 2022 The €6,900,000 in the quarter ended March 31, 2023. An increase in personnel costs were offset by Net finance income and costs for the quarter ended March 31, 2023 decreased From income of about €500,000 in the quarter ended March 31, 2022 to costs of about €500,000 in the quarter ended March 31, 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.

Speaker 6

Dollars as a result of currency fluctuations between the U. S. Dollar and the euro during the year. Net loss for the quarter ended March 31, 2023 was €32,000,000 or 0 point 21 dollars per common share Compared with a net loss of €16,700,000 or €0.14 per common share for the quarter ended March 31, 2022. The weighted number of common shares outstanding for the quarter ended March 31, 2023 was 149,300,000.

Speaker 6

Additional information regarding these results is included in the notes of the consolidated financial statements as of March 31, 2023, which will be included in Affimed's filings with the SEC. I'll now turn the call back to Adi for closing remarks. Adi?

Speaker 2

Thanks a lot, Angus. Now moving to Slide 19, we show a snapshot of And we're very excited on behalf of patients that could benefit from the combination treatment of AFM13 with AB101 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 small cell lung cancer and colorectal cancer studies, during which we are also planning to update you And now we're on the plans for AFM24 going forward. And as you've heard, are indeed Quite excited about the progress we are making with AFM28 in AML, which we believe Has a huge potential, as we mentioned in the past that NK cells can play a major role in AFM28, We're also thankful for the support And efforts of our employees who have pulled together to move things forward. It is through their dedication and the support From you and the patients and their families that gives us inspiration to continue our growth of bringing these life saving therapies We are now ready to take questions and I hand back to the operator.

Operator

Our first question comes from the line of Maury Raycroft with Jefferies. Maury, your line is now open.

Speaker 7

Hi. Thanks for taking my questions. Question on the iluminiest study, presumably the SIMON-two stage design part of the study is open label, Wanted to clarify that. And then also wondering what is the bar for success on overall response rate and duration of response? And is there anything additional you're saying on powering for the study?

Speaker 2

Yes, thanks. Good morning. Good morning. So Handing this question over to Wolfgang.

Speaker 4

Wolfgang?

Speaker 6

Okay. You may be on mute.

Speaker 4

Yes. Thanks, Angus. Hi, Maury. As you can see on Slide number 10, the dose optimization, right, we have 2 cohorts selected from the safety run-in, 13 patients per cohort, and each of these cohorts We'll follow assignment stage 2 design. So that means we are evaluating each of these Cohort separately writes to its utility whether to move forward, yes or no.

Speaker 4

That's number 1. The other question was the PAR success. But Based on the data we have generated with AFM13104, right, 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?

Speaker 7

If you're saying anything additional on powering for the study?

Speaker 4

Andreas, do you want to take that question regarding the power of the credit?

Speaker 5

Yes, I can take this question. As Wolfgang has said and as I think it's also depicted on the slide, The second part of the study, which starts with 2 doses selected from the initial four Cohorts and then the option to continue basically into the expansion consists of 2 separately Powered SIMON 2 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 1 or 2 cohorts Until the final number of 55 patients per cohort. This was something that specifically came out of our discussions With FDA and I think it's also in line with FDA's attempt to have more data available on dose optimization and The effect of different doses on the outcome.

Speaker 5

So again, these two arms are separate 2 stage Arms which do not have a statistical comparison between the two arms.

Speaker 7

Got it. Makes sense. And Anything else you can tell us about the nature of nature or timing of FDA discussions to be had on registration requirements. I guess, would that be first half twenty twenty four after you get the run-in 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

Speaker 5

Yes, well, Boston, go ahead. Yes.

Speaker 4

Yes. So we have designed that study with the 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 said that single arm study is still feasible 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 guidance or feedback regarding their concerns.

Speaker 7

Got it. Okay. Thanks then. Thanks for taking my questions.

Operator

Our next question comes from the line of Leigh Watsack with Cantor Fitzgerald.

Speaker 8

Hey, guys. Thank you for taking our questions. Maybe just follow-up on, I guess, the registration application, understanding that You're still in the process of that with the agency, but I guess can you give us a sense of what Kind of different scenarios that you're preparing for here?

Speaker 4

I mean, We are in constant contact with our project management, FDA, and we'll determine the next steps. Once agreed with the time lines, 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.

Speaker 8

Okay. Got it. And then just for the safety and run-in portion, I guess, do you need to discuss With the agency before you proceed, to the optimization dose portion or it will be pretty seamless? And I guess for the safety running portion, how long is the follow-up?

Speaker 2

So the first question, you want to take that?

Speaker 4

Yes. Sorry, Adi. The first question, right, These patients are treated as outlined on the slide we have provided. I guess it's Slide number 11. And also these patients can receive up to 3 cycles.

Speaker 4

The assessment for selecting 2 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. No, the FDA provided full commitment to that study.

Speaker 8

Okay. Thanks.

Operator

Our next question comes from the line of Sreekripa Divarikonda with Truist Securities.

Speaker 3

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 said Q3, 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? It's about 24 patients in first half. And is there any likelihood that we could see we could also see enrollment In Stage 2 by then, not data, but at least enrollment.

Speaker 3

Thank you.

Speaker 2

Again, Wolfgang?

Speaker 4

Yes. So first question, we are preparing for 1st patient in Q3 2023, I think we are fully on track on that. So we are interacting with the CROs, we are interacting with the sites, etcetera, etcetera. 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 H1, 2024.

Speaker 4

Did you have another question? Sorry, maybe I missed it.

Speaker 3

Sorry, sorry, I was on mute. I was just wondering if by the time you have the data, is there should we expect enrollment to already begin in Stage 2 of the trial as well.

Speaker 4

I mean, we will start with Stage 2 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 2. When that exactly will be, I can't say.

Speaker 3

Okay. Thank you. That's helpful.

Operator

Our next question comes from the line of Brad Canino with Stifel.

Speaker 9

Hi. Thanks for the updates. I'm looking at Slide 10 here for the dose expansion portion where it says you'll select 1 or 2 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

Speaker 2

Welcome again.

Speaker 4

Yes. So after the dose optimization, the patient will be follow-up for 2 treatment cycles. And after these two treatment cycles, right, the decision will be made, the interim analysis will be made and then a decision based on the Simon, 2 stage design to move forward or not to move forward. So after 2 treatment cycles, 2 assessments.

Speaker 9

Okay. Thank you. And then as you continue the FDA discussions, can you help us understand how much your partner is Included in these, particularly I'm thinking about how much buy in they might have if one of the decisions that are being to run a concurrent confirmatory

Speaker 4

So Heidi, I'll take that at least the first part and then I give it to you for the second part. The partnering with Arteva is going very well. It's a very nice and very good collaboration on a team level, on a transdering committee level, And we are all aligned in our interactions with the FDA. We align before we discuss, right, and have A common path forward, right? So that's going really well.

Speaker 4

Regarding the confirmatory study, right, and their commitment, I will hand over to Adi. Adi, please.

Speaker 2

Yes. Contractually, as 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 are fully focused on getting the IND cleared. And obviously, our Arkeva has played a major So as we are 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 confirmatory studies we were contemplating. We have already mentioned in the past that we have obviously a number of options in Hodgkin lymphoma where we can place it, And we also focused in terms of moving forward with the PTCL, at least initially based on the cohort findings that on the findings within the 20 patient That's our plans, yes.

Speaker 9

Okay. Appreciate the comments. Thank you.

Operator

Our next question comes from the line of Dana Graybosch with SVB Securities.

Speaker 10

Hi. This is Raveed on line for Dana. The questions we have are surrounding ASCO in particular, especially in regards to Arteva. What are you looking for this first disclosure in clinical data from Arkeva, given that this product is being used for the Moving on to the 2 zero three trial as opposed to the Anderson product from previous data. And then What are we looking for in the AFM24 monotherapy data in CMC and ILCLC That gives us confidence for future readouts in second half twenty twenty three with the combination with NK cells and or

Speaker 2

Yes. Thanks for the question. I'll hand over to Andres, please.

Speaker 10

Yes. So

Speaker 5

it's a difficult to answer question because it relates basically In all parts to data that will be published at ASCO. As you know, for Ativa, Ativa has an ongoing study that evaluates both of the AB101 cell as a single product, So without targeting agent and here they are looking at a couple of different dose levels in patients with B cell malignancies And they also have the combination of AB101 cells with rituximab, so we're targeting agents in B cell malignancies. And they will provide update on the current status 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 to newer data are under ASCO embargo. For AFM24, again, we We'll show updated data for the patients with EGFR mutant non small cell lung cancer treated with single agent AFM24, we will also have an online publication for the colorectal cancer cohort. Again, both will have updated data compared to the abstracts that come available or become available later this week.

Speaker 5

And as we said, after our poster presentation, we will also host an investor event to have a comprehensive discussion of the AFM24 strategy, of course, taking into account the new data set we will show at ASCO. But I think until then, I unfortunately cannot share more details with you.

Speaker 10

Just a Short follow-up. We've heard that companies are permitted to provide updated data after the abstracts Are released if the data are different than what was written in the abstract. Is that something we can look for from Acovid?

Speaker 6

Yes. Adi, maybe I can take that one. Yes, please. Thank you for the question. It's something we've obviously looked very, very closely at.

Speaker 6

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 host an investor call subsequent to the poster discussion To provide further updates on AFM24. So that was the decision that's kind of what went into our decision to wait until June 3 and as Luke mentioned, the abstracts with the December cutoff date will be published on Thursday.

Speaker 10

Thank you so much.

Operator

Our next question comes from the line of Yale Jen with Laidlaw.

Speaker 11

Good morning and thanks for taking the questions.

Speaker 6

Good morning. Good morning.

Speaker 11

Good morning. How are you? Sorry. My first question is that you guys I mentioned that in the press release that you're going to have preclinical data presented at the ICML. My question is that what should we anticipate from that data release?

Speaker 11

And Do you show anything comparison to the cord blood cell derived

Speaker 4

NK cell as well?

Speaker 2

Andreas, do you want to take the question, please?

Speaker 5

When it's relating to preclinical, I think Arnd would Probably be the right person to respond.

Speaker 2

Okay. Sorry. I'm

Speaker 5

happy to take your 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, we will show preclinical data the combination of the products And some of that we had actually previously shown also at some investor conferences. So we will show the preclinical basis for moving into the clinic. So you can expect that there's it's a logistic activity to be shown.

Speaker 5

But I cannot Share more specifics that will be shared at the conference, I'm sure you'll understand.

Speaker 11

Sure. Not a problem and thanks for that. And maybe just one more housekeeping question. Also in the press release, you indicated that The Genentech collaboration,

Speaker 4

at least for

Speaker 11

the time being, seems completed. You handed out the product. So just for modeling purpose, should we anticipate the revenue be slightly lower going forward as you Elyse, I assume there's only 1 collaboration partner at the moment until otherwise.

Speaker 4

Andrew?

Speaker 6

Yes, I can take that. So as you mentioned, Greg, the work that we were responsible for 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've been recognizing revenue, which is associated with the upfront payments we received under that collaboration Over time based on a complete percentage of completion basis. So naturally, we have Now recognize the bulk of the revenue from the upfront payments we received.

Speaker 6

There will be a small tail on that for certain I'll turn 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 Voyvant as we have Move forward towards completion of the work we have there and now recognize a large proportion Of the upfront payments we received under that collaboration, an easy way to sort of tell what may be coming in the next 12 months is to look at The contract liabilities that we have, the short term portion of the contract liabilities we have and that should give you An estimate for what we would expect to recognize over the course of the next 12 months.

Speaker 11

Okay, great. That's very helpful and detailed and thanks and congrats on all the progress.

Operator

Our next question comes from the line of Zhiqing Chu with Berenberg.

Speaker 12

Hi. Thank you for taking my question. This is Andy on for Z. Regarding your Phase 2 trial, it looks like you're doing 4 cohorts, Two doses for AFM13, two doses for NK cell therapy. Can you please remind us how were those doses selected and what's your level of confidence behind those And my other question is regarding the restructuring, 25% of your employee.

Speaker 12

How does that how is that going to affect your operating expenses going forward? If you can provide some guidance, please. Thank you.

Speaker 2

Yes. Thanks for asking. I will hand over the second question to Angus and then move back to Wolfgang. Angus?

Speaker 6

Sure. So I mean, looking at the reorganization on its own in the vacuum, I mean, the reduction in headcount costs That we would expect on an annualized basis is in the range of about €5,000,000 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 the global impact on an annualized basis. So on its own, the reorganization We'll have roughly $5,000,000 annualized impact on operating expenses that will be spread across our R and D and G and A.

Speaker 6

And then obviously within that context, there are other investments that Primarily in the early stage pipeline that will be reduced. So over time, we do expect to see both In particular, the R and D numbers start to come down. We've actually we're kind of at a period here as a company where we have overlapping programs. AFM13202 study Winding down, our work as mentioned on the Genentech Roivent 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.

Speaker 2

And now moving back to Wolfgang.

Speaker 4

Okay. The question was the dose selection So the safety run-in cohort, let's start with AFM13. And for AFM13, we have a recommended Phase 2 dose of 200 milligram flat, right, which has been used also in the PTCL trial, but which we also used in the AFM13104 trial. And we decided also to evaluate a 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 NK cells That we are providing meaningful higher number of CD16A binding sites and therefore higher doses of AFM13 may be needed to optimize receptor This has been the reason for the 200 milligram and the higher dose of 300 milligram.

Speaker 4

When we move to the AB101, these two doses have been selected, of course, after discussion With the colleagues from Arteva, and these are based on initial data from their ongoing Phase I study, which Andreas mentioned earlier, The initial data from this study will present at ASCO as he said and therefore are under embargo at that time. Therefore, we cannot further comment on this. Does that answer your question?

Speaker 12

Yes. Thank you. Congratulations again.

Speaker 4

Thanks. Thank you.

Operator

Our next question comes from the line of Swayampakula Ramakanth with H. C. Wainwright.

Speaker 13

Thank you. This is Riz RK from H. C. Wainwright. So most of my questions Have been answered.

Speaker 13

Just want to understand on AFM-twenty 8 and See, what's the update you can provide in terms of how the Phase 1 study is Currently enrolling and should we expect any data in 2023?

Speaker 2

Andreas, you want to take that, please?

Speaker 5

Yes. 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 2 patients. However, these patients are required to receive 4 infusions of AFM-twenty eight to be dose Limiting toxicity evaluable.

Speaker 5

So as we said, we don't have seen any DLTs, which allowed us to open the 2nd cohort. So currently, we are enrolling patients That's 50 milligrams, and we are extremely satisfied with this kind of speed. Again, we have not made detailed plans whether and in which form to release data from the initial cohorts, but that's Something that we will provide guidance, I would say, in the very near future.

Speaker 13

Thank you. Thanks.

Operator

Our next question comes from Yanan Zhu with Wells Fargo Securities.

Speaker 14

Hi. Thanks for taking the questions. Two quick ones on the Phase 2 trial. The first one is on the Cadence of enrollment, do you have to have safety Evaluation for each patient or a 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 accelerated approval path, I was wondering, do you think that discussion We'll require data from the Phase 2 trial.

Operator

Yes. Thank you.

Speaker 2

Welcome.

Speaker 4

Yes. Okay. Now to the first question, right, that's the study design. If you look at Slide number 10, you can see that Cohort 12 start in parallel And then Cohort 34 start in parallel. What we do, the first patient of each cohort We'll go first and then there is a staggering and we wait 7 days before we start with the second Patient.

Speaker 4

So there is for the first patient, there is a staggering of 7 days. Now The second question, the additional discussion, whether it will require Phase 1 data or not, Currently, we can't say. As I mentioned before, right, we are in Joe's interaction with the FDA to determine next steps and then move that forward. But we do not know and cannot speculate right on the position of the FDA. And therefore, we cannot comment on that Currently, because it's too premature.

Speaker 4

Thanks for understanding.

Speaker 14

Understood. Thanks for the answers.

Speaker 4

Welcome.

Operator

That concludes today's question and answer session.

Remove Ads
Powered by Quartr
Earnings Conference Call
Affimed Q1 2023
00:00 / 00:00
Remove Ads