Affimed Q2 2023 Earnings Call Transcript

Quartr
Provided by Quartr
August 10, 2023

There are 15 speakers on the call.

Operator

Good day, everyone, and welcome to Affimed's Second Quarter 2023 Earnings and Corporate Update Call. As a reminder, today's conference call is being recorded. I would now like to introduce your host for today's call, Alex Psutikidis, Head of Investor Relations at Affimed. Please go ahead.

Speaker 1

Thank you, Chris, and thank you all for joining us today for our Q2 Before we begin, I'd like to remind everyone that we issued the relevant press release and presentation 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 Our Chief Executive Officer, Adi Hurst, Andreas Hairstrich, our Chief Medical Officer Arndtjotelius, our Chief Scientific Officer Wolfgang Fischer, our Chief Operating Officer and 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 everyone that today's presentation contains projections and forward looking statements regarding future events. These statements represent our belief and assumptions As only as of this date of this call, except as required by law, we assume no obligation to update these forward looking statements publicly or to update the reasons why actual results could differ materially from those anticipated in the forward looking statements, even if new information becomes available in the future.

Speaker 1

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?

Speaker 2

Thank you, Alex. Good day, everyone, and thanks for joining us today. I'm delighted to welcome you all to our 2nd quarter results and business update for 2023. I will take a moment to reflect on the good progress that we have made at Affimed over the past few months. Let's move to Slide 5, please.

Speaker 2

1st and foremost, I'm pleased to share with you That we are continuing to make significant progress across all of our pipeline. We have 3 ongoing clinical programs And we have the potential to generate meaningful data over the next 12 months. As presented, Our innate tailengager molecules are capable of delivering single agent activity and show a benign Safety profile in a broad number of heme and solid tumor indications. This benign safety profile now allows us for a number of different therapeutic combinations, And our focus is on combinations with allogeneic NK cells and checkpoint inhibitor. Now for both combinations, we have generated impressive proof of concept data with AFM13.

Speaker 2

The success of AFM13 in combination with NK cell in Hodgkin lymphoma patients, we have exhausted any of its prior treatments As we know it's Daniel. We're now leveraging this valuable experience In the AFM13-two zero three or laminized-two zero three study, where we will combine AFM13 with the allogeneic NK cell product AB-one hundred and one. This promising combination holds Tremendous potential for revolutionizing treatment for Hodgkin's and T cell lymphoma patients. We continued our discussions with the FDA And based on their feedback, we have requested a Type C meeting to further discuss the requirements for an accelerated approval based on the Luminiz-two zero three study. Our FDA approved protocol includes Q learnings from earlier clinical studies.

Speaker 2

Now to April 24, we announced at ASCO that going forward, we will be focusing our development assets on the combination with antizolizumab. The data we presented from our monotherapy study created optimism within the medical community and we are working to capitalize on this momentum. We have seen activity of AFM24 mono In all three indications tested, EGFR mutant non small cell lung cancer, renal cell carcinoma and colon cancer, including partial responses, tumor shrinkage and or durable stable diseases. The activity now of AFM24 was most pronounced in the EGFR mutant non small cell lung cancer cohort with 2 partial responses And 5 stable diseases observed in only 15 patients. And just to remind us, these are heavily pretreated patients.

Speaker 2

From the Phase 1 to MONO study, we have further learned that there's not only an activation of NK cells, but also of T cells, and both are redirected now into the tumor upon AFM24 therapy. This is why we have added an additional expansion cohort to the atiselizumab combo study to investigate EGFR mutant NSCLC with this combination. In fact, we have received a regulatory approval and The new cohort is now open for recruitment in Europe and the U. S. Now we believe this new expansion cohort will bring us valuable data that demonstrate Shifting gears again, I'm now pleased to share with you that our 3rd innate and engager in the clinic AFM 28 is advancing rapidly through dose escalation.

Speaker 2

We have successfully completed the 2nd dose cohort without any dose limiting toxicities. And we are now actively treating patients in the 3rd dose cohort, which is a flat dose of 100 milligrams once weekly. Finally, we continue to be in a good position. We have ample cash to execute our business plan into 2025 and this financial stability provides us with the freedom to pursue our focused goals without compromise while we continue to drive innovation in cancer treatment. Now as we move forward, we're eagerly anticipating several upcoming inflection In the next 2 months, we'll have a promise to further revealing the potential of our therapies to provide clinically meaningful Benefit in difficult to treat cancer.

Speaker 2

For AFM13, we're expecting to have further discussions with the FDA regarding the suitability of the LUMINI-two zero three study to support the potential accelerated approval. Next, we are expecting initial We're also expecting more mature data from AFM13104 to be presented by MD Anderson at ASH in December. For AFM24, we are to report data on the combination of AFM24 with atezolizumab at a company event in the Q4 of this year. And with AFM 28, we are developing a novel therapy for 1 of the most in need patient population in relapsedrefractory AML. Our recent progress with the dose escalation is Very promising, and we will continue to update you as we proceed.

Speaker 2

In our view, we've made solid progress and look forward to meaningful updates over the next With that, let me turn the call over to Andreas, who will provide to you additional insights. Andreas?

Speaker 3

Yes. Thank you, Adi, and also welcome from my side and thanks to everyone on the phone for listening in. I'm happy to give you an update of the clinical progress of our 3 programs. And here I will start with the progress in AFM13. As we told you on our last call, we have received clearance from the FDA to proceed The allogeneic NK cell product.

Speaker 3

We have made significant progress towards our goal of getting the study up and running and have generated interest from over 25 sites in the U. S. To participate, showing our commitment and dedication to advancing this innovative treatment. We are now in the final stages of site activation and expect to have the first sites open for patient recruitment in the September, October timeframe. Importantly, we believe that this will enable us to report initial data from the study in the first half of twenty twenty four.

Speaker 3

As all patients will be treated with active doses of AFM13 and AB101, even in the initial cohorts, We believe this initial data update will provide already a meaningful insight into both efficacy and safety of this treatment regimen. Furthermore, as Adi mentioned, we have taken proactive steps to follow-up and engage with FDA and have requested a Type C meeting with the agency. The purpose of this meeting is to further discuss the requirements for an accelerated approval based on the LUMINIZE-two zero three study. Based on FDA guidelines, we Expect the meeting to be scheduled in the Q4 of 2023. Our proposed clinical study design is shown on Slide 78.

Speaker 3

As shown on Slide 7, the study will commence with 4 cohorts Evaluating 2 different doses of AFM13 and 2 different doses of AB101, focusing on patients with relapsed And refractory classical Hodgkin's lymphoma. It's important to note that all 4 cohorts will use doses of AFM13 and AB101, That we believe are active doses. 2 of these 4 doses will then be selected for the next step, The first part of the SIMON 2 stage design and finally, our intention is to select one schedule for the final expansion part. This design addresses FDA's guidance for the market, as for example outlined in the Project Optimus guidelines. In addition, we plan to start of this cohort treating paraffarot cell lymphomas CD30 positive and this cohort should commence next year.

Speaker 3

On Slide 8, you see the design of an individual treatment cycle of the study. After lymphodepleting therapy with modest doses of cyclophosphamide and flutarabine, A regimen that has been tested and demonstrated to be safe even when used multiple times, patients will receive AB101 cells And AFM13 on 3 consecutive weeks once weekly, followed by 3 weekly applications of AFM13 single agent. It is planned to give up to 3 cycles in patients who show a response. This design builds on experience from other NK cell studies and on our experience with AFM13 in the AFM13104 study. The weekly application of NK Of note, early data of AB101, again given weekly, in combination with Rituxan has shown good safety profile and promising activity in patients with refractory B cell lymphomas as recently published at ASCO.

Speaker 3

The application of weekly AFM13 for 3 additional weeks is based on data from the 104 study, Where it could be shown that free AFM13 is capable to load repopulating patients' own NK cells, thus providing a dual attack on the tumor. We are also reducing the interval between cycles, thereby preventing regrowth of tumor cells between cycles. Taken together, we think that the study design gives us the best chance to produce Deep and lasting remissions in these difficult to treat patients. Additionally, as Adiorenci mentioned, as far as the 104 study is concerned, We expect MD Anderson to present updated data from this study at ASH later this year. This data will provide a comprehensive analysis of further demonstrating the potential of AFM13 in combination with NK cells.

Speaker 3

And now if we turn to AFM24, as announced during ASCO, we will focus our clinical development program with AFM24 on the combination with atezolizumab in the near term. In our AFM24 monotherapy study, as you know, we investigated AFM 24 in patients with colorectal cancer, renal cell carcinoma and EGFR mutant non small cell lung cancer. Important to note that in this study, we were treating late line patients that have often failed multiple prior lines and have no further treatment options. As shown on Slide 9, at ASCO, we presented data that showed clear signs of Activity across all three cohorts. We are particularly encouraged by the partial responses, tumor shrinkage and stable diseases That AFM24 could produce in heavily pretreated patients with EGFR mutant non small cell lung cancer, including 2 confirmed partial responses and 5 patients with stable disease, which includes additional 3 patients with tumor volume reduction.

Speaker 3

Importantly, AFM24 exhibited a favorable safety profile with manageable infusion related reactions being the most common side IFM24 did not induce severe EGFR mediated toxicity in the skin or mucosa, which is commonly associated with other EGFR targeting agents. As said earlier, the study also investigated patients with colorectal cancer and renal cell carcinoma. And again, the data demonstrated tumor shrinkage or reductions in target lesions across both tumor types. Some of these patients showed prolonged stability of their once progressive disease, including, for example, 1 renal cell carcinoma patient achieving a substantial 28% reduction in target lesions just shy of another partial response. As shown on Slide 10, based on the very encouraging activity of AFM24 mono In EGFR mutated non small cell lung cancer, we have added a 4th cohort to the ongoing combination study with Atezolizumab.

Speaker 3

Based on amendment filed earlier with regulatory agencies, This cohort is now open for patient enrollment. Moving forward, we believe that AFM24's role in activating the immune system By specifically triggering NK cells and macrophages to destroy tumor cells and liberate tumor associated antigens is crucial. These antigens can then be processed by macrophages and dendritic cells, leading to the activation and clonal expansion of tumor reactive T cells as shown in our earlier studies. The combination of AFM24, which activates the innate immune system With atiselizumab, which enhances the adaptive immune system, therefore, has a logical rationale. As Eddie also mentioned, we plan to present an update from the ongoing combination trial with atiselizumab at the company event in the Q4.

Speaker 3

Finally, data from the dose escalation portion of AFM24 in combination with the autologous cell product SNK-one was recently presented at ASCO Breakthrough. In this study, 7 patients with a mean number of 5 prior lines of therapy received the combination of AFM24 as SNK-one. No unexpected or dose limiting toxicities were observed and the PK properties of AFM24 were similar to AFM24 monotherapy. We believe that this first human study of an ICE in combination with adoptive NK cell transfer established the feasibility of this novel combination approach. Of note, the stabilization of disease in heavily pretreated patients With microsatellite stable colorectal cancer was considered by our lead investigator, Doctor.

Speaker 3

Elkuri as clinically meaningful. Based on the learnings from this study, we are evaluating options to advance AFM24 with an allogeneic off the shelf NK cell product, which we believe will better be suited for the combination with AFM24. Let's now turn to AFM 28. And on slide 11, we are providing the update of AFM 28, which was specifically designed to address CD123 positive myeloid malignancies, including acute myeloid leukemia. We have made significant progress in advancing the clinical development of AFM28.

Speaker 3

First, we have successfully cleared the 2nd dose cohort administering 50 milligrams of AFM 28 weekly 2 patients with heavily pretreated AML without encountering any dose limiting toxicities. Building on these data, we have now started the 3rd cohort where we are administering a 100 milligram Flat dose once weekly to AML patients. This positive development highlights a favorable safety profile and tolerability of AFM28. Moreover, we were also encouraged by data presented at ASCO with a different NK cell engager Also targeting CD123 that validated this target as a druggable target and showcased an acceptable safety profile. This is of importance as many other CD123 directed approaches such as T cell engages, CAR Ts Our antibody drug conjugates have shown high toxicity including fatal cases at low doses leading often to terminations of these programs.

Speaker 3

In our assessments, the new data likely mean The targeting CD123 is possible within K cell engagers with manual toxicity. This is important as CD123 is considered a highly promising target being expressed not only on leukemic blasts, but also on leukemic stem cells. We believe these results further emphasize the potential of AFM-twenty eight as a therapeutic target for AML patients. Additionally, preclinical data presented at the European Society For blood and marrow transplantation conference earlier this year highlighted the promise of AFM28. The data demonstrated the effective induction of NK cell mediated lysis of AML blasts and leukemic stem cells.

Speaker 3

Notably, AFM28 exhibited activity even at low CD123 expression levels and remained unaffected by the CD64 expression on leukemic cells. We believe these characteristics more frequent remissions and associated with the safe toxicity profile. Given the aggressive nature of AML and the urgent need for viable treatment options, we are diligently working to expedite the availability of AFM28 for relapsed and refractory AML patients. With this, I will conclude my update on the clinical progress and turn the call over to Angus, to update you on the quarterly financial numbers. Angus, please?

Speaker 4

Thank you, Andreas. Balance sheet and income statement highlights are shown on Slides 13 and 14 of the presentation. A quick reminder that Affinit's consolidated financial statements have been 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 numbers that I have mentioned in this call, unless otherwise noted, will be in euros.

Speaker 4

As of June 30, 2023, cash and cash equivalents totaled €120,100,000 compared to €190,300,000 as of December 31, 2022. Based on our current operating plan and assumptions, we anticipate that our cash and cash equivalents will support operations into 2025. Net cash used from operating activities for the quarter ended June 30, 2023 were €33,300,000 compared to €26,500,000 in the Q2 of 2022. Operating cash flow for the quarter was adversely impacted by a change in working capital of €7,500,000 which included €4,300,000 for changes in trade and other payables and €2,700,000 for changes in other assets and prepaid expenses. The change in trade and other payables was driven primarily by payment of manufacturing costs for AFM13 and AFM24 They were expensed in prior periods, while the change in other assets and prepaid expenses was driven by $3,100,000 of prepayments associated with the Luminize 203 trial, partially offset by a reduction in the amount of certain insurance prepayments.

Speaker 4

Total revenue for the quarter ended June 30, 2023 was 1 point EUR4 1,000,000 compared with EUR7,300,000 for the quarter ended June 30, 2022. Revenue predominantly relates to the Roivant and Genentech collaborations. R and D expenses for the quarter ended June 30, 2023 increased by 21.3% from $20,800,000 in the quarter ended June 30, $22,000,000 to $25,300,000 in the quarter ended June 30, 2023. The increase was primarily due to higher expenses associated with the development of AFM13 and AFM24, a result of increased costs related to the scale up of production of AFM13 for commercial purposes as well as costs incurred for procurement of clinical trial material, increased clinical trial costs and manufacturing costs, and an increase in costs associated with other early stage G and A expenses decreased 25.1 percent from $8,400,000 in the quarter ended June 30, 2022 to $6,300,000 in the quarter ended June 30, 2023. The decrease was due to a decline in legal, consulting and insurance expenses

Speaker 5

as well

Speaker 4

as share based payment expenses. Worth noting is that total operating expenses for the Q2 were down 15% as compared to the Q1 of 2020 We expect to see a continued reduction in operating expenses over the next several quarters due to the reorganization that we announced in May, The completion of our work on the Genentech and Roivant collaborations and the completion or wind down of certain clinical activities such as AFM13202, AFM13-one hundred and four, AFM24-1 hundred and one and AFM24-1 hundred and three as well as the timing of certain manufacturing expenses for AFM13, which for a weighted towards the 1st 2 quarters of 2023. Net finance income and cost for the quarter ended June 30, 2023 decreased from income of €2,300,000 in 2022 to income of €47,000 in the quarter ended June 30, 2023. Net finance income costs are largely due to foreign exchange gains and losses related to assets denominated in U. S.

Speaker 4

Dollars as a result of currency fluctuations between the U. S. Dollar and the euro. Net loss for the quarter ended June 30, 2023 was 29 point €4,000,000 or $0.20 per common share compared with a net loss of €19,400,000 or $0.13 per common share for the quarter ended June 30, 2022. The weighted number of common shares outstanding for the quarter ended June 30, 2023 of $149,300,000 Additional information regarding the results is included in the notes to the consolidated interim financial statements as of June 30, 2023, which are included in Affinet's filings with the U.

Speaker 4

S. Securities and Exchange Commission. I will now turn the call back to Adi for closing remarks. Marty?

Speaker 2

Thanks a lot, Angus. Let's move to Slide 16. On this slide, now we show a a snapshot of all our programs and upcoming milestones. In summary, As I already introduced, we have multiple meaningful milestones that we can meet within the next 12 months. This includes the initiation of Luminiz-two zero three targeting relapsedrefractory Hodgkin and peripheral T cell lymphoma patients.

Speaker 2

Our data already has shown that we can achieve higher Our deep and careful analysis shows that more than about 10,000 relapse refractory Hodgkin and peripheral T cell lymphoma patients comprise the total market opportunity comprise this market opportunity. So however, as we've learned from the KOL and the payer landscape study, the data from AFM13 in combination with alloy and K cells was so intriguing that this may offer price at or even above CAR Ts. With this, I'd like to express my sincere gratitude to our dedicated team, Wustyle's efforts have propelled us to where we stand today. Their unwavering commitment and passion for improving patient outcomes has been the cornerstone of our success. Together, we will continue to push the boundaries of medical innovation And bring hope to those cancer patients who they did most.

Speaker 2

Now thank you All for your support, and I look forward to an engaging and informative session today. We're now ready to take questions. Operator?

Operator

Thank Our first question will come from Maury Raycroft of Jefferies. Your line is open.

Speaker 6

Hi, good morning and thanks for taking my questions. I had a question on AFM13203 study. So the Type C meeting is expected to happen in Q4. Based on your timeline, what data from the 203 study could you show to By that point, I know it would be early, but could you potentially have initial overall response rate and safety data for the run-in phase by the time of that meeting?

Speaker 2

I'll hand this question over to Wolfgang, please.

Speaker 5

Yes. Hi, Mary. This is Wolfgang. As you might know from our previous discussions and disclosures, the Type C meeting is about to address The request from the FDA, which makes our LUMINI study feasible to be an accelerated for registration directed study for accelerated approval. And we had interactions with the FDA, and the FDA let us know that They are requesting the contribution of the single agents.

Speaker 5

That's their question. And based on this, right, we put together all the documents, etcetera, and submitted a Type C meeting request, where we will discuss with the FDA how to best address these requirements for an accelerated approval based on our Luminiz-two zero three study. And once we have had that meeting and aligned with the FDA on the approach, right, we will disclose that. Does that answer your question?

Speaker 6

Well, I think so. But it sounds like you may not have initial data from the 203 study to discuss At that point. Is that fair or

Speaker 5

This is not the objective of this Type C meeting, right? Also our questions Around the contribution of the single agent. And as Andreas mentioned in his part, right, we are about to activate These the study sites September, October and of course as soon as we have that right we will start recruitment of patients.

Speaker 6

Understood. That makes sense. And what are your base case expectations at this point in terms of what a registrational study could look like?

Speaker 5

I mean, when you also what we discussed and disclosed earlier, but The FDA granted us that study and we clearly asked for sets registration directed trial. And the FDA said there is open questions from their side. And then we clarified that in the request for clarification, and the result was that they're asking for the contribution of the single agents. And that's now what we are following up.

Speaker 6

Understood. And last question and then I'll hop back in the queue. For the first half of twenty twenty for update for the 203 study. How substantial would that update be in terms of number of patients? What stage of the study?

Speaker 6

And how much follow-up could you potentially have?

Speaker 2

Andreas?

Speaker 3

Yes. As you see from the trial design, the focus clearly will be on the patients who are treated in the first For cohorts, so 4 times 6 patients that go initially on study, given that As Wolfgang said, we will start or we have trials sites open in October. I think the main focus of this initial update will be clearly safety, But also response rate, of course, by the nature of when we start the study and then when we want to give the updates, the follow-up at this point in time will Be relatively limited. So focus will clearly be on response rate and safety.

Speaker 6

Got it. Okay. Thanks for taking my questions.

Operator

Thank you. One moment please for our next question. Our next question will come from Dana Grebosch of Leerink Partners. Your line is open.

Speaker 7

Hi, thank you for the question. I'm going to ask more about FDA's request on contribution of components. So a multipart question on that. When they asked about contribution of components, which components are they inquiring about? Obviously, AFM13 and the NK cells, are they also including IL-two, which is new and asking about contribution of components.

Speaker 7

That's the first question. And the second question is, how are you proposing to CA that you show contribution of component of the NK cell specifically. And then maybe you could also address how you're going to show contribution of component for AFM13. Thank you.

Speaker 5

Yes. Wolfgang. Hi, Dana. This is Wolfgang. So number 1, yes, the FDA asked for contribution of single agents, including AFM13, AB101 and IL-two.

Speaker 5

The way how we are proposing that, I mean, we have a proposal and sent that to the FDA. And of course, we first want to discuss with the FDA whether that approach is feasible, right? And then, of course, we disclose. In particular for when you ask for AFM13, right, for AFM13, we have I do not know how many patients, but way more than 100 patients treated with in Hodgkin lymphoma, where we clearly know what the contribution The single agent is. And we know that the response rate is between 11% 16%.

Speaker 5

So this is does that answer your question?

Speaker 7

Yes. I agree that ASM-thirteen, I think, is pretty clear I think what's less clear is the AV-one hundred and one and the IL-two, how you're going to demonstrate that. So I was interested in those proposals.

Speaker 5

Yes. No, we have a proposal, right, and that's also what we sent to the FDA. And as soon as we have an alignment here, we are going to disclose that.

Speaker 7

Maybe one follow-up question. Which group at FDA is primarily asking these questions and leading to review? And which groups are involved in advising?

Speaker 5

Yes. So It's cyber and cider. Both of them are involved, right? So they gave that feedback together.

Speaker 7

Thank you.

Speaker 8

Sure.

Operator

Thank you. One moment please for our next question. Our next question will come from Leigh Watsack of Cantor Fitzgerald. Your line is open.

Speaker 9

Hey, good morning. Thank you for taking our questions. I guess just Follow-up on the Type C meeting for AFM13. And then in terms of the confirmatory stay, can you just Clarify if that will be part of the conversation at the meeting. And then in terms of communication, just straight about the feedback, Would you wait for a meeting minutes or if so, should we still expect to hear back from you guys this year?

Speaker 2

Wolfgang, do you want to take this again?

Speaker 5

Yes. I can I need to yes? The last question, whether you will hear from us this year? Yes, right, because we expect the feedback according to the FDA guidelines in Q4 this year, right? And but we all know what we experienced in the past, right, where there was some delay.

Speaker 5

So but according to the FDA guidelines, as I said, right, we expect that in Q4, definitely. And then could you please repeat your first question? I didn't get that completely, sorry.

Speaker 9

In terms of the confirmatory study, just wondering if that will be part of the conversation as well?

Speaker 5

No, that will it's really about the contribution of the single agents, right, because The confirmatory will then come after that.

Speaker 9

Okay. And then in In terms of study starts for the Phase 2 study, I guess, what are the gating That's here to subdosing the first patient in the next couple of months. I mean you mentioned there are 25 sites Interested. So just trying to understand where you are in that and anything you can do to Accelerate the process?

Speaker 2

Andres?

Speaker 3

Yes, we are taking all possible measures already To accelerate the process, but as you may know, once you go to site initiation, there are certain legal contractual steps That you have to do on the site level, there's also additional review committee involved. So we are working through all these steps. We Having very close contacts to our primary investigators, so I think we are probably as fast as we can, but There are certain things in site initiation that just cannot be shortcut. But as we said, we have high interest from sites and We expect to have a substantial number of sites open in the Q4 and this has resulted also in our guidance that we are comfortable to provide first data updates first half of next year.

Speaker 9

Okay. Thank you.

Operator

Thank you. And one moment please for our next question. Our next question will come from Yale Jen of Laidlaw and Company. Your line is open.

Speaker 10

Good morning and thanks for taking the questions. Just wanted to follow-up a little bit in terms of the first half twenty twenty four data release of 2023 study. Given that you will start the first two cohorts first and then Subsequently, the second the next two cohorts later as well as the patient was sort of stacking between the first and second initially. So what obviously, depending on the pace of enrollment, What should we anticipate in general for the data release at that in the 4th quarter to I'm sorry, In the first half of next year, what level of patient number level of patients could be We should be as anticipated.

Speaker 2

Andreas, do you want to take that?

Speaker 3

Yes. I mean, it's To some degree, of course, depends on the speed in which we can initiate the sites. As I said, we feel that we are on a good way here. Now when you carefully look at the study design, these 4 cohorts are overlapping. So we only have A staggered approach for the first two cohorts and here also not for all patients.

Speaker 3

So basically once we have A couple of patients in the first two cohorts, all 4 cohorts can start to enroll patients more or less simultaneously. So we think that we should have all 24 patients enrolled. And For the majority of these patients, we should have, as I said, safety and response data.

Speaker 10

Okay, great. That's very helpful. And then maybe just one more Housekeeping questions. You guys indicated that the 2 partnerships are going to renegotiate or discuss the future collaborations. So should we anticipate that At least in the short term, for example, starting next quarter or Q3, the revenue will be Substantially reduced or how should we look into that for modeling purpose?

Speaker 4

Yes, it's Angus. Let me just correct something you said. We didn't say anything about renegotiating partnerships. What we said is that we have Completed the work that we were contractually obligated to do under Genentech and Roivent collaborations and handed the molecules over to them. So from that perspective, we made that comment to highlight the fact that our expenses Per contract under those collaborations are now substantially complete.

Speaker 4

The go forward development of the molecule That have been handed over or at the discretion of our partners. And as we've said in the past, I mean, you can get a pretty good sense for what we expect to recognize revenue from those collaborations over the next 12 months by looking at the current portion of our contractual liabilities. But The revenue recognized under those collaborations will be lower than in past periods. But again, as a reminder, that revenue is non cash And it's recognition of upfront payments that were received under those collaboration.

Speaker 10

Okay, great. That's very helpful. And Good luck and congrats on the progress.

Operator

Thank you. One moment please for our next question. The next question will come from Yanan Zhu of Wells Fargo. Your line is open.

Speaker 5

Hi, thanks for taking our questions. I wanted to follow-up a little bit on the FDA question. In terms of your response, Would you would the response involve modification of the Study design, for example, including more cohorts with varying doses of each component? Or would your response be mainly focusing on things like maybe preclinical evidence or literature research. And also, is there any evidence in the literature that suggests And K cells alone, even with IL-two could have any efficacy in Hodgkin's lymphoma?

Speaker 5

Thanks. Yes. Thank you for this.

Speaker 2

Andreas, do you want to take that question first on the efficacy?

Speaker 3

Yes. So on the efficacy part, this I think is an ongoing discussion. To our knowledge, there has not been a data set generated, a clinical data set that specifically looks at Non targeted NK cells in Hodgkin's lymphoma. There are several data sets for Non targeted NK cells in non Hodgkin's lymphoma, which consistently show Very modest activity, if activity at all. So targeting really appears to be essential in the lymphoma tissues.

Speaker 3

And This will be one of the discussions with FDA whether FDA would want to see a specific clinical testing of In case of Plus IO2 or whether they basically acknowledge the experience and the data that had been generated in the Non Hodgkin lymphoma settings. So that is one of the, I think, key questions that will be discussed. As I mentioned in my introductory remarks, We have already taken into account some guidance when it comes to different doses and schedules. So we are addressing the OPTIMOS Initiative of FDA, as you see, we start out with 4 basically cohorts with different doses schedules narrowed down to 2 and Finally, based on the data narrowed down to 1, so we would not expect that the dose and scheduling question comes up with FDA. So I think the negative NK cell will be the key Point that will be discussed with FDA.

Speaker 5

Got it. Thank you. That's very helpful.

Operator

Thank you. One moment please for our next question. Our next question will come from Srivreetha, Durrantzakonda, Truist Securities. Your line is open.

Speaker 11

Hey, guys. Good morning. Thank you so much for taking my question. So regarding the Type C meeting, I have a follow-up question. In terms of the package that you need to submit, do you already have that ready to go?

Speaker 11

I think you need to submit it a few weeks ahead of the meeting. And what is the likelihood that the FDA might say, wait for early preliminary data from The Part 1 or Stage 1 of the study before they think it is meaningful to have this discussion. And on the partnership With Genentech and AffyVant, you've completed your part of the work. Is there a timeframe before which the partners are required to make a gono go decision on these assets? Thank you.

Speaker 2

Yes. So I'll hand it over to Wolfgang again.

Speaker 5

I start with the Type C meeting. Yes, you are correct, right? You need to submit your package briefing book, etcetera, before the meeting. And yes, we are preparing that and we are on track to submit that in due time. That's the first question.

Speaker 5

You said what is the risk that the FDA say wait until you have first data before we discuss? We think that risk is small because it's really a specific request from the FDA. And the FDA invited us For an interaction for Type C meeting to discuss that with them. So therefore, it's our belief that this risk is very small, if at all. Great.

Speaker 5

Does that answer your question?

Speaker 2

Yes. And if you want to speak about the collaborations?

Speaker 4

Yes. And then in terms of the collaborations, I mean, no specific timeframe in which the assets would have to move Forward, again, as we said, those the decision to move that forward is at the discretion of The partners as well as the community at this stage of the collaboration, the communication around moving forward is also at the discretion of the partners.

Speaker 11

Thank you.

Speaker 4

There is standard kind of commercially reasonable effort type of clauses as well.

Operator

Thank you. One moment please for our next question. Our next question will come from Andy Chen of Berenberg. Your line is open.

Speaker 12

Hey, thank you for taking my question. So another question about the Type C meeting with the FDA. Is the FDA just Curious about single agent contribution or do they require single agent contribution for accelerated approval to be possible? Just if you don't know, like I'm wondering if you can speculate on like why the FDA is asking for this information and what they're thinking in their head?

Speaker 5

Welcome. Thanks for the question. Thanks for the question, Andy. The FDA is requesting that, Right. And also when you read the FDA guideline, right, it's also there that when you have combination, The contribution of single agents need to be investigated, right?

Speaker 5

So that's it's a request. It's not they are not just curious. Okay.

Speaker 12

So it needs to be investigated, but it doesn't need to be like strongly positive, right?

Speaker 5

Correct. You need to provide a plan. You need to provide an idea how you demonstrate that contribution of the simulation, And that's what we are going to do and to discuss with the FDA during the Type C.

Speaker 12

Got it. And the other question is about Artiva's The ASCO data, so they saw, I think, 2 out of 15 well, out of 15 patients, they saw 2 cases of CRS at 1,000,000,000 cells single dose. And I'm wondering because you're like for your LUMINIZE trial, you're going to be doing higher doses and multiple cycles. And I'm wondering like how do you think about the risks of doing that in the trial?

Speaker 2

Andreas, Can you take that question?

Speaker 3

Yes. I think and I would have to go back to the original data From the post a bit, as far as I recall, these were very mild cases of CRS, often very difficult to distinguish from classical infusion related reaction. Overall, I think the cell so far has shown a remarkably good safety profile. And of course, we will take somewhat higher doses, again, not higher than the doses that are tested now. As you may know, Artiva is currently looking at 4,000,000,000 NK cells per infusion, so per week.

Speaker 3

And we have not heard any indication of new or unexpected toxicity. So our current belief is that this approach will be very safe and could be administered for multiple cycles.

Speaker 12

Got it. Thank you.

Operator

Thank you. And again, one moment please for our next question. Our next question will come from Swayampakula Ramakanth of HCW. Your line is open.

Speaker 13

Thank you. This is RK from HFC Vanwright. Good afternoon, Adi and Andreas. I've been juggling within calls, so I apologize if these Just in terms of AFM-twenty eight, In terms of the monotherapy part of the study, what sort of data should we expect from here to end of the year? And in terms of the combination part of the study, what else needs to get done Before you could start that trial.

Speaker 3

I just want to make sure You're meeting AFM28 because you said also combination part of the study, which AFM28 does not have. So but let's start with the first Question. So as you know, we are in a dose escalation study. We have moved very quickly through the first two dose escalation cohorts, I have not seen any dose limiting side effects. We are currently enrolling into our 3rd cohort.

Speaker 3

The study has a Bayesian dose escalation design. So we cannot predict at this point how many dose We will finally take and as we said, we will provide you with updates on the progress as we go along during the course of the year. Now I'm not sure what you mean with the combination study because as far as IFN 28 is concerned, currently we only have the dose escalation study in our portfolio. As we said, we actively look also into options to combine with an NK cell. But this is a strategic effort that the company is currently undertaking without a firm protocol yet.

Speaker 13

Yes. Thanks, Andreas. My apologies. What I meant was your plan to See whether the combination is feasible, that's what I meant. I apologize for that.

Speaker 2

Andres?

Speaker 3

Whether the combination with EnkeiCell is Feasible. Yes, we believe it's feasible based on all what we have seen. But again, the first strategic effort that we have Is to identify NK cell that we could take forward into our AFM-twenty eight program.

Speaker 13

Thank you. Thanks for taking my questions.

Operator

Thank you. One moment please for our next question. Our next question will come from the line of Bradley Canino of Stifel. Your line is open.

Speaker 14

Hey, good morning. This is Bijan on Brad and Eno, thanks for taking my question. Another question on the FDA Type C meeting. Is it going to require multiple FDA meetings to get clarity on the requirements for registration and the confirmatory strategy or do you expect to have answers for the both of those after this 4Q meeting?

Speaker 2

Wolfgang?

Speaker 5

Yes. Thanks for the question. As we said before, right, the Type C meeting is really focusing on the contribution of the single agents and to discuss with the agency how we can address that best to make Luminiz feasible for registration directed study for accelerated approval. That's the focus of the Type C meeting. Now when it comes to confirmatory study, no, the confirmatory study will not be discussed at that Type C meeting.

Speaker 5

That will be separate.

Speaker 14

Got it. And just one more question. On the AB101 ASCO poster, Yes. What are the takeaways from that poster that give you confidence it will produce a similar effect in combination to MD Anderson's NK Cells?

Speaker 2

Andres?

Speaker 3

Yes. I think of course it's very early data when you look at the ASCO poster. It's with Very low numbers of sales, but still even in patients who were coming from CAR T treatment, they have seen complete and partial responses. Our confidence is not only based on the ASCO poster, but also on all of the extensive preclinical works that we have done with Of the AB-one hundred and one cell, again, hard to test head to head against the MD Anderson cell as MD Anderson is a fresh cell product, could not be shipped, so we were not able to run a head to head comparison, but in very comparable models and Arndt probably can speak More to that, but in every model that we tested to sell, we have seen at least comparable activity compared to the data that we have generated with ZMT Anderson cell.

Speaker 8

Yes. Just to quickly add this, Bjorn, this is As Andreas said, when we compare co dosing to pre complexing, you remember in vitro, we actually saw that Slightly better than pre complexing. And the models we have done with CerroCore Administration, absolutely equivalent to the ones that we have done with MD Anderson. And you may remember of seeing the ICML poster where we again showed we have full saturation of 13 on AD101 after cryopreservation. Very important that also is possible After cry preservation and have shown that convincing mouse moth are going there.

Speaker 14

Appreciate the answers.

Operator

Thank you. I see no further questions in the queue. This will conclude today's conference call. Thank you all for participating. You may now disconnect and have a pleasant day.

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