Q2 2023 Affimed NV Earnings Call
Okay.
Good day, everyone and welcome to <unk> second quarter, 2023 earnings and corporate update call.
Minder today's conference call is being recorded.
I would now like to introduce your host for todays call, Alex what Akitas head of Investor Relations at Acclimate. Please go ahead.
Thank you Chris and thank you all for joining us today for our second quarter 2023 update call 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, Eddie Hurst.
Andreas <unk>, our Chief Medical Officer Arent Shaquille. He is our Chief Scientific Officer, Wolfgang Fischer, Chief operating Officer, and Denise Mueller, Chief Business Officer, and Angus Smith, our Chief Financial Officer, the team will be available for Q&A. After the prepared remarks before we start I'd like to.
To remind everyone that today's presentation contains projections and forward looking statements regarding future events. These statements represent our beliefs and assumptions as only as of the date of this call except as required by law, we assume no obligation to update these forward looking statements publicly or to us.
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 subjects 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.
That I will turn the call over to Audi Audi.
Thank you Alex Good day, everyone and thanks for joining us today.
I'm delighted to welcome you.
All to our second quarter results and business update call for 2023.
I will take a moment to reflect on the good progress that we've made.
Over the past few months.
Let's move to slide five please.
First and foremost I'm pleased to share with you that we are continuing to make significant progress across all of our pipeline.
We have three ongoing clinical programs.
And we have the potential to generate meaningful data over the next 12 months.
As a percentage our you know telling data molecules are capital 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 allows us for a number of different therapeutic combinations.
Our focus is on combinations with allogeneic NK cells and checkpoint inhibitor.
Now proposed combinations, we have generated impressive proof of concept data with <unk>.
The success of <unk> in combination with NK cell in Hodgkin lymphoma patients.
We have exhausted any of its prior treatments has been outstanding.
We're now leveraging this valuable experience.
In the AFM 13.
Two or three or looming is two or three study, where we will combine <unk> with allogeneic NK cell product.
101.
And its promising combination holds tremendous potential for revolutionizing treatment for Hodgkin's and T cell lymphoma patients.
We continue with our discussions with the FDA.
Based on their feedback we have requested a type C meeting to further discuss the requirement.
An accelerated approval based on the Illumina is two or three weeks ago.
Our FDA approved protocol includes key learnings from earlier clinical studies.
Now I'm trying to get.
We announced that ask or that going forward, we will be focusing our development efforts on the combination with Ts relieves amuck.
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 824 mono in all three indications tested.
Egfr mutant non small cell lung cancer renal cell carcinoma.
In colon cancer, including partial responses tumor shrinkage and four.
Durable stable disease.
The activity now from 2004 was most pronounced in the Egfr mutant non small cell lung cancer cohort with two partial responses and five stable diseases observed and only 15 patients.
And just to remind us these are heavily pre treated patients.
From the phase one.
Two mono study we are further learned that that's not only on activation of NK cells.
Lots of T cells.
And both are redirected now into the tumor upon as from 'twenty for therapy.
This is why we have added an additional expansion cohorts.
Two the <unk> combo study to investigate the Egfr mutant and Israel.
With this combination.
In fact, we have received a regulatory approval.
And the new contract is now opened for recruitment in Europe and the U S.
Now we believe this new expansion cohort will bring valuable data that demonstrate the potential of 24 in this very difficult to treat solid tumor indications.
Shifting gears again please.
Sure.
With you that our third and engagement in the clinic from 2008 is advancing rapidly through dose escalation.
We have successfully completed the second dose cohort without any dose limiting toxicities and we're now actively treating patients in the third dose cohort.
Which is a flat dose of 100 milligrams once weekly.
Finally, we continue to be in a good position we have.
Cash to execute our business plan into 2025, and this financial stability provides us with the freedom to pursue our focus goes without compromise, while we continue to have great innovation in cancer treatment.
Now as we move forward, we're eagerly anticipating several upcoming inflection points.
The next two months holds the promise to further revealing the potential of our therapies to provide clinically meaningful benefit in difficult to treat cancer.
From 13.
We're expecting to have further discussions with the FDA regarding the suitability.
After aluminized, two or three study to support the potential accelerated approval.
Next we are expecting initial efficacy data from this study in the first half of 2024.
Also you're expecting more mature data from.
<unk> 104 to be presented by MD Anderson at Ash in December .
For you from 'twenty four we are expecting to report data on the combination of April 24, with chase and visa.
And a company event in the fourth quarter of this year.
And with any from 2008, we are developing a novel therapy for one of the most in need patient population.
Relapsed refractory <unk>.
I am.
Our recent progress with a dose escalation is very promising and drilled will continue to update you as we proceed.
Now a few we've made solid progress and look forward to meaningful updates over the next few months.
With that let me turn the call over to address.
We'll provide additional contract.
Yeah. Thank you audience also welcome from my side and thanks to everyone Who's a falloff on the phone for listening in.
Happy to.
Give you an update of the clinical progress of our three programs.
Yes, I will start with the progress and AFM 13.
As we told you on our last call. We have received clearance from the FDA to proceed with the initiation of a phase two clinical trial in which I guess I'm certain will be evaluated in combination with it would be one to one see allogeneic NK cell product.
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 announced the final stages of site activation and expect our first sites open for patient recruitment.
September October time frame.
Importantly, we believe that this will enable us to report initial data from this study in the first half of 2024.
It's all patients will be treated with active doses of AFM 13, EB 101.
Even in the initial cohorts. We believe this initial data update will provide already a meaningful insight into both the efficacy and safety of this treatment regimen.
First of all Morris you mentioned, we have taken proactive steps to follow up and to 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 that Illumina is two or three study.
Based on FDA guidelines, we expect for meeting to be scheduled in the fourth quarter of 2023.
Our proposed clinical study design is shown on slides seven and eight.
As shown on slide seven with the study will commence with four cohorts.
I think two different doses of AFM 13, and two different doses of <unk> 101.
Focusing on patients with relapsed and refractory classical Hodgkin's lymphoma.
It's important to note that all four cohorts would use doses of AFM 13, and AB 101, respectively.
We believe our active doses.
Two of these four doses will be selected for the next step so first part of the Simon two stage design.
And finally, our intention is to select one scheduled for a final expanded expansion part.
<unk> signed addresses the fda's guidance to generate data on different doses early in the course of clinical development and to make informed decisions on the dose that will be further developed for the market.
For example outlined into project Optimus guidelines.
In addition, we plan to start a fifth cohort treating peripheral T cell lymphomas city, certainly positive and this.
Cohort should commence next year.
On slide eight you will see is the design of an individual treatment cycle of study.
After lymphoid depleting therapy, it with modest doses of cyclophosphamide and Fludarabine.
A regimen that has been tested and demonstrated to be safe, even when used multiple times.
<unk> will receive a 101 self <unk> and 13.
Three consecutive weeks once weekly.
Followed by three weekly applications of AFM 13 single agent.
It is planned to get up to three cycles in patients who show a response.
Fifth design built on experience from other NK cell studies and on our experience with AFM 13 from certain 104 study.
The weekly application of NK cells may offer more and longer exposure cause.
The tumor to NK cell mediated cytotoxicity.
Off note early data of AB 101, again, given the weekly.
In combination with Rituxan has shown good safety profile.
And promising activity in patients with refractory B cell lymphoma as recently published at ESCO.
So the application of weekly AFM 13 for three additional weeks is based on data from the 104 study where it could be shown that free I S. I'm certain is capable to load repopulating patient's own NK cells <unk>.
Thus, providing a dual attack on the tumor.
We are also reducing the interval between cycles, thereby preventing re gross 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 audio Red Sea mentioned as far as C. 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 the efficacy durability and safety outcomes.
Observed in patients with C. D 30 positive lymphomas further demonstrating the potential of AFM 13 in combination with NK cells.
And now if we turn to AA from 24 S announced during ESCO.
We will focus our clinical development program from 24 on the combination with TS released a map in the near term.
In our air from 'twenty for Mono therapy study as you know we investigated asked some 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 has no further treatment options.
As shown on slide nine at ESCO, we presented data that showed clear signs of activity across all three cohorts.
We are particularly encouraged by is a partial responses tumor shrinkage and stable diseases.
Some 24 could produce in heavily pretreated patients with Egfr mutant non small cell lung cancer <unk>.
Including two confirmed partial responses and five patients with stable disease, which includes additional three patients with tumor volume reductions.
Importantly, I am from twenty-four exhibited a favorable safety profile with manageable infusion related reactions being the most common side effect.
I am from 24 did not induce severe egfr mediated toxicity into skin or mucosa.
Commonly associated with other Egfr targeting agents.
As said earlier the study also investigators 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 a prolonged stability of their once progressive disease, including for example, the one renal cell carcinoma patient achieving a substantial 28% reduction in target lesions just shy of one as a partial response.
As shown on slide 10 based on the very encouraging activity off air from 'twenty for mono therapy in Egfr mutated non small cell lung cancer. We have added a fourth cohort to the ongoing combination study with soft tissue laser map.
Based on an amendment filed earlier with regulatory agencies. This cohort is now open for patient enrollment.
Moving forward, we believe that air from 'twenty false roll and activating the immune system by specifically, triggering NK cells and macrophages to destroy tumor cells and liberate the tumor associated antigens is crucial.
So 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.
So a combination of higher from 'twenty, four which activates the innate immune system was that Ts for Liza map, which enhances the adaptive immune system, therefore has a logic or rationale.
That's all that you also mentioned we plan to present, an update from the ongoing combination trial with a T cell lease them up at the company event in the fourth quarter.
Finally data from the dose escalation portion of <unk> from 24 in combination with the autologous cell product NK cell product Snk. One was recently presented at ESMO breakthrough.
In this study of seven patients with a mean number of five prior lines of therapy.
It received a combination of a year from 24.
K O one.
No unexpected or dose limiting toxicities were observed and so.
PK properties of ire from 24 were similar to F 'twenty for monotherapy.
We believe that this first human study of an ICU in combination with adoptive NK cell transfer establish the feasibility of this novel combination approach.
Of note is the stabilization of disease and heavily pre treated patients with microsatellite stable colorectal cancer was considered by our lead investigator Dr. Corey is clinically meaningful.
Based on the learnings from this study we are evaluating options to antibiotics from 24 with an allogeneic off the shelf NK cell product, which we believe will better be suited for is the combination with <unk> 24.
Let's now turn to <unk> 28, and.
And on Slide 11, we are providing the update.
From 2008, which was specifically designed to address the CD 123.
Positive myeloid malignancies, including acute myeloid leukemia.
We have made significant progress in advancing the clinical development of fire from 28.
First we have successfully cleared the second dose cohort administering 50 milligrams of <unk> from 28 weekly to patients with heavily pretreated AML.
Without encountering any dose limiting toxicities.
Building on these data we have now started the third cohort, where we are administering 100 milligrams flat dose once weekly to AML patients.
So it's a positive development highlights the favorable safety profile and Tolerability of air from 28.
Moreover, we were also encouraged by data presented at ESCO was a different NK cell engaged are also targeting CD 123 set validated this target as a drug or a target and showcase an acceptable safety profile.
So this is self importance as many other CD 123 directed approaches.
S T cell engages car Ts or antibody drug conjugates have shown high toxicity, including fatal cases at low doses, leading also to terminations of these programs.
And our assessments of new data likely mean, the targeting CD 123 is possible with NK cell engagement, which manner with toxicity.
So this is important as CD 123 is considered the highly promising target.
Being expressed not only on the leukemic blasts, but also on leukemic stem cells.
We believe these results further emphasizes the potential for error from 24 28, as a therapeutic target for AML patients.
Additionally, preclinical data presented at the European Society for blood and marrow transplantation conference.
Earlier this year, highlighting the promise of <unk> 28.
So they must data demonstrated effective induction of NK cell mediated license of AML blasts and leukemic stem cells.
Notably from 28 exhibited activity, even at low CD 123 expression levels.
And remained unaffected by the CD 64 expression on leukemic cells.
We believe these characteristics distinguish <unk> from 2008 from other approaches.
And suggests the possibility of deeper antitumor activity more frequent true remissions and associated with a safe toxicity profile.
Given the aggressive nature of email and urgent need for a viable treatment options. We are diligently working to expedite the availability of air from 28, four relapsed and refractory AML patients.
With this I will conclude my update on our clinical progress and turn the call over to Angus to update you on our quarterly financial numbers Angus. Please.
Thank you Andreas.
Balance sheet and income statement highlights are shown on slides 13, and 14 of the presentation.
A quick reminder, that afternoon consolidated financial statements have been prepared in accordance with IRS and issued by the international accounting standard board or <unk>.
The consolidated financial statements are prepared in euros, which is the companys functional and presentation currency. Therefore, all numbers that are.
Unless otherwise noted will be in euros.
As of June 32023, cash and cash equivalents totaled about $120 1 million euros compared to a 193 million euros as of December 31 2022.
Based on our current operating plan and assumptions, we anticipate from our cash and cash equivalents will support operations into 2025.
Net cash.
Activities for the quarter ended June 32023.
33, 3 million euros, compared to 26 5 million euros and the second quarter of 2022.
Operating cash flow for the quarter were adversely impacted by a change in working capital of seven 5 million euros, which included $4 3 million euros or changes in trade and other payables and $2 7 million for changes in other assets and prepaid expenses.
The change in trade and other payables was driven primarily by payment of manufacturing cost per ASM 13, an ASM 24 that were expensed in prior periods, while the change in other assets and prepaid expenses was driven by $3 $1 million of prepayments associated with illuminate two or three trial, partially offset by a reduction in the amount of certain insurance prepayments.
Total revenue for the quarter ended June 32023 was $1 4 million euros, compared with $7 3 million euros for the quarter ended.
As of June 32022.
Revenue predominantly relates to the ROI math and Genentech collaborations.
R&D expenses for the quarter ended June 32023 increased by 21, 3% from $20 8 million in the quarter ended June 32022 to $25 3 million in the quarter ended June 32023.
The increase was primarily due to higher expenses associated with the development of AFM 13, and <unk> 24.
A result of increased costs related to the scale up of production of <unk> 13 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 programs and infrastructure.
G&A expenses decreased 25, 1% from $8 4 million in the quarter ended June 32022 to $6 3 million in the quarter ended June 32023.
The decrease was due to a decline in legal consulting and insurance expenses as well as share based payment expenses.
Worth noting is that total operating expenses for the second quarter were down 15% as compared to the first quarter of 2023, we expect to see a continued reduction in operating expenses over the next several quarters due to the reorganization that we announced in May.
Leasing of our work on the Genentech and Roche collaborations and the completion of our wind down of certain clinical activities, such as <unk> <unk> to <unk> 13, one a 424 101, and <unk> 24, and 103 as well as the timing of certain manufacturing expenses for <unk>, <unk>, which were weighted towards the first few quarters.
<unk> of 2023.
Yeah.
Net finance income and cost for the quarter ended June 32023 decrease from income of $2 3 million euros in 2022 to income of 47000 in the quarter ended June 32023.
Net finance income costs are largely due to foreign exchange gains and losses related to assets denominated in U S. Dollar.
As a result of currency fluctuations between the us dollar and the euro.
Net loss for the quarter ended June 32019.
$9 4 million euros, and <unk> 20 per common share compared with a net loss of $19 4 million euros or <unk> 13 per common share for the quarter ended June 32022.
Weighted number of common shares outstanding for the quarter ended June 32023, the $149 3 million.
Additional information regarding the results is included in the notes to the consolidated income statements as of June 32023, which are included in <unk> filings with the U S Securities and Exchange Commission.
I will now turn the call back to <unk> for closing remarks.
Thanks, a lot of Angus metric.
Let's move to slide 16 on this right now we show a snapshot a snapshot of all our programs.
And our upcoming milestones.
In summary.
As I already introduced we have multiple meaningful milestones that you can meet within the next 12 months.
This includes the initiation of Leumi now has two or three Todd.
Targeting relapsed refractory Hodgkin.
And our referral T cell lymphoma patients.
Our data already has shown that we can achieve higher response rates in patients.
Have exhausted all approved treatments.
<unk> been careful analysis shows or the more of that about 10000 relapsed refractory Hodgkin.
And peripheral T cell lymphoma.
Ah patients comprise.
Total market opportunity.
This market opportunity.
So how are you.
So we've learned from the Kols and the payer landscape study.
Data from <unk> in combination with our NK cells.
So intriguing, but this may also pricing or even the bus car Ts.
With this I'd like to express my sincere gratitude.
Our dedicated team.
Whose tireless efforts have propelled us to where you stand today.
They're wavering commitment and passion for improving patient outcomes.
The cornerstone of our success.
Together, we will continue to push the boundaries of medical innovation and bring hope to those kinds of patients.
It depends.
No. Thank you.
All for your support.
And I look forward to engaging and informative session today.
We're now ready to take questions operator.
Thank you.
To ask a question. Please press star one one on your phone and wait for your name to be announced to withdraw. Your question. Please press star one one again standby as we compile the Q&A roster.
And one moment please for our first question.
Okay.
Our first question will come from Maury Raycroft of Jefferies. Your line is open.
Yeah.
Hi, good morning, and thanks for taking my questions Hydro question on AFM 13 tier three study so the type C meeting.
I expect it to happen in the fourth quarter based on your timeline what data from the <unk> III study could you show to the FDA by that point I know it would be early but could you potentially have.
Initial overall response rate and safety data from the run in phase by the time of that meeting.
I'll hand, this question over to most countries.
Yeah, Hi, this is Scott.
As you might know from our previous discussions and disclosures.
Type C meeting is about to address the request from the FDA, which makes our aluminite study feasible to be an accelerated.
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 agent that's that's the question.
And based on this right we put together all the documents et cetera.
And submitted 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 Illumina is two or three study.
And once we have had that meeting and aligned with the FDA on the approach right, we will disclose that.
That answer your question.
Well I think so but it sounds like you may not have initial data from that two or three study to discuss at that point.
Is that fair.
This is not the objective of this type C meeting our questions are around the contribution of the single agent.
And as <unk> mentioned in his part right.
To activate these.
The study sites September September October and of course as soon as we have that but it will start recruitment of patients.
Understood that makes sense and what are your base case expectations at this point in terms of what a registrational study could look like.
I mean, when you when you also what we discussed and disclosed earlier.
But the the.
The FDA granted us that study and we clearly.
Four four or.
Registration directed trial and the FDA that there is a there is open questions from their side and then we clarified that in a in a request for clarification and the result was that they're asking for the contribution of the single agents and Thats not what we are following up.
Understood and last question and then I'll hop back in the queue for the first half of 'twenty four update for the two or three study how substantial was that update in terms of number of patients what stage of the study and how much follow up could you potentially have.
Andreas.
Yeah, so as you'll see from the trial design is a focus clearly will be on the patients who are treated in the first.
Four cohorts so four times six patients go initially on study.
Given that that's Wolfgang said, we will start or we have three sites open in October I think the main focus of this initial update will be clearly safety, but also response rate of course by by the nature of when we start the study and when we want to give the updates of follow up at this.
Point in time will be relatively limited so focus will clearly be on response rate and safety.
Got it okay. Thanks for taking my questions.
Yeah.
Thank you.
One moment. Please next question.
Yeah.
Our next question will come from Dana.
<unk> of Leerink partners. Your line is open.
Hi, Thank you for the question I'm going to ask more about Fda's request unconstitutional component. So a multi part question on that.
I asked about contribution of components, which component.
Are they enquiring about obviously <unk> 13, and a D. NK cells are they also including IL, two which is new and asking about contribution of components. That's the first question and the second question is how are you proposing to FDA that you see.
Contribution of component of the NK cell pacifically.
And then maybe you could also address how youre going to show contribution of component for AFM 13. Thank you.
Yeah.
Hi, Dana.
This is wes.
So number one yes, the FDA asked for contribution of single agents, including <unk> 81 to one and two.
But the way the way how we are proposing that I mean, we have a proposal and sent that to the FDA.
We first wanted to discuss with the FDA, whether whether that approach is feasible and then of course, we disclose.
In particular for when you ask for <unk>, but for <unk>, we have.
I do not know how many how many patients but way more than 100 patients treated with <unk> in Hodgkin lymphoma, where we clearly know what the contribution of the single agent is and we know that.
The response rate is between 11% and 16%.
So this is does that answer your question.
Yes, I agree the ASM 13, I think it's pretty clear on contribution I think what's less clear is the 81 to one in the IL two how youre going to demonstrate that so I was interested.
This proposal.
Yeah, No we have a proposal that and that's also what we send to the FDA and as soon as we have an alignment here, we're going to disclose that.
Maybe one follow up question Whats group that FDA is primarily asking these questions and leading to review.
And in which groups are involved in advising.
Yeah. So it's a it's cyber insider.
Both of them are involved right. So they they gave that feedback together.
Alright, thank you.
Sure.
Thank you.
One moment please for our next question.
Our next question will come from Lee <unk> of Cantor Fitzgerald. Your line is open.
He has been mined.
We cannot question I guess just follow up on the type C meeting for E S.
Our team and then in terms of the confirmatory study can you just clarify that will be part of their compensation of meeting.
And then in terms of communications in Germany about the feedback.
Would you wait for meeting minutes or if so should we still expect to hear back from you guys. This year.
Craig do you want to take yet again.
Yes, I can.
Yeah. The last question, whether you will hear from US this year, yes, but because we expect the feedback according according to the FDA guidelines.
In Q4 this year.
But we all know what we experienced in the past right, where where there was some delay so but according to the FDA guidelines as I said, but we expect that in Q4 definitely.
And then could you. Please repeat your first question that didn't get that completely sorry.
That comes from Germany.
Just wondering if that will be part of the compensation as well.
But no that's.
Well.
It's really about the contribution of the single agents right because the confirmatory. The confirmatory will then come after that.
Okay.
And then in terms of study start.
For the phase two study I guess.
What are the gating that's here to start dosing the first patients in the next couple of months and you mentioned there are 25 sites.
Interesting so I'm just trying to understand.
Where you are in that and anything you can do to accelerate the process.
Andreas.
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.
But you have to do on the site level that's awesome.
Revenue Committee involved so we're working through all of these steps we are having.
Having very close contact 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 shortcuts.
As we said we have high interest from sites and we expect to have a substantial number of sites.
In the first and the fourth quarter and this has resulted also in our guidance that we are comfortably comfortable.
To provide for state updates first half of next year.
Okay. Thank you.
Thank you.
And one moment please for our next question.
Okay.
Our next question will come from Yale Jen of Laidlaw <unk> Company. Your line is open.
Good morning, and thanks for taking the question.
The follow up a little bit in terms of the first half.
24 data release.
<unk> III study.
Given that you you would.
The first two whole cohort 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.
What.
Obviously, depending on the pace of enrollment.
Enrollment.
What should we anticipate an agenda.
For the data released at the.
Fourth quarter, two I'm sorry.
First half of next year.
What level of patient number.
Level of patients could be.
We should be anticipating.
The address you want to take that.
Yeah.
To somebody's greed of course it depends on the.
The speed in which we can initiate sites as I said, we feel that we are on a good way here.
Now when you carefully look at the study design is for cohorts are overlapping so we only have a <unk>.
<unk> approach for the first two cohorts into your ultimate for all patients so basic.
Basically once we have a couple of patients in the first two cohorts all four cohorts can start to enroll patients more or less simultaneously.
So we.
Thinks that we should have all 24 patients.
And for the majority of these patients we should have as I said safety and response data.
Okay, Great. That's very helpful. And then maybe just one more housekeeping question.
You guys indicated that debt.
Two partnership.
Colin.
Renegotiate I'll discuss the future.
Elaboration.
Should we anticipate that.
At least in the short term.
But starting next.
Next quarter or the third quarter Ts.
Revenue will be substantially reduced or how should we look in that.
For modeling purpose, yes, okay.
Yeah, let.
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 ROI Mac collaborations and handed the molecule over to them.
So from that perspective.
We made that comment and to highlight the fact that our expenses are.
Contract under those collaborations.
Are now substantially complete.
The go forward development of the molecules that have been handed over are at the discretion.
Our partner.
And as we've said in the past you can get a pretty good sense for what we expect to recognize revenue from those cut those collaborations over the next 12 months by looking at the current portion of our contractual liabilities, but since we recognized revenue on a percentage of completion basis for each of those collaborations.
And we have now substantially completed our work it's fair to assume that the revenue recognized under those.
<unk> will be lower than that in past periods, but again as a reminder, that revenue is noncash.
And its recognition of upfront payments that were received under the collaboration.
Okay, Great that's very helpful and.
Best of luck and congrats on the progress.
Okay.
<unk>.
Okay.
Thank you.
One moment please for our next question.
The next question will come from Yanan Zhu.
Wells Fargo. Your line is open.
Hi, Thanks for taking our questions I wanted to follow up a little bit on the FDA.
FDA question a question in terms of your recent bumps.
Would you.
Would the response involves modification of the study design.
For example, including more cohorts with varying doses of each component.
Or would your response be mainly.
Focusing.
It seems like maybe preclinical evidence or literature research.
And also is there.
Any evidence in the literature that suggest NK cells alone.
Even with Iot could have any efficacy in Hodgkin's lymphoma.
Yes.
Yeah. Thank you for your shallow Andreas do you want to take that question first on.
On the.
Please proceed.
Yeah, so the efficacy part.
I think it's an ongoing discussion.
To our knowledge there has not been a data set generated clinical data sets or specific he looks at.
Non targeted NK cells in Hodgkin's lymphoma.
There are several data sets for <unk>.
Quote quote non targeted NK cells in March non Hodgkin's lymphoma, which consistently show very modest activity.
<unk> had also targeting really appears to be essential in lymphoma tissue sent.
This will be a one off discussions with FDA, whether FDA wants to see a specific clinical testing of NK surplus IL, two or whether they.
Basically ignored, let's see experience since the data as it had been generated in the non Hodgkin lymphoma setting. So so is that just wanted to see I think a key question set 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 is the Optimus initiative of FDA as Youll see we start out with four.
Basically cohorts with different dosing schedules narrowed down to two and finally based on the data and narrow down to one so we would not expect us to dose and scheduling question comes up with FDA. So I think it's a naked NK. So it will be the key point that will be discussed with FDA.
Got it. Thank you that's very helpful.
Yeah.
Thank you.
One moment please for our next question.
Yeah.
Our next question will come from <unk> <unk>.
On conduct twist Securities. Your line is open.
Hey, guys. Good morning. Thank you so much for taking my question.
So regarding the type C meeting I have a follow up question.
The package that you need to submit do you already have that predictable I think you need or you need to make 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 pipeline stage one of the.
A study before they think it is meaningfully to have those discussions.
And on the partnership with Genentech in coffee that you've completed your part of the works is that a timeframe before which the partners are required to make a go no go decision on these assets. Thank you.
Yes, so I'll hand, it over to Wolfgang again.
I'll start with that with the type C meeting.
Yes, you are correct right you need you need to submit you'll need to submit your packaged precinct book et cetera, before the meeting and yes. We are preparing that and we are on track to submit that in two time.
That's the first question.
<unk> said what is the risk that the FDA say wait until you have first data before we discuss we think that risk is.
<unk>, because it's really a specific request from the FDA and the FDA invited us for a while and.
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.
Okay.
Yes.
Do you want to speak about the collaborations yes.
And then in terms of the collaborations.
Specific timeframe.
In which the assets.
What would have to move forward again, as we said those dose.
The decision to move that forward is at their discretion.
The partners as well as the community at this stage of the collaboration and the communication around moving forward is also at the discretion of the partners.
Thank you there are standard kind of commercially reasonable efforts type of clauses as well.
Okay.
Thank you.
One moment please for our next question.
Okay.
Our next question will come from.
Andy Chien of Baird. Your line is open.
Okay.
Thank you for taking my question. So another question is about the type C meeting with the FDA.
The FDA just curious about single agent contribution or do they require a single agent contribution for accelerated approval to be possible. Just if you don't know I'm wondering if you can speculate on why the FDA is asking for this information and what theyre thinking in their head.
Okay. Thanks for the question. Thanks for the question Andy.
The FDA is requesting that try it and also when you read the FDA guideline. It's also dance that when you have combination.
The contribution of single agents need to be investigated red. So that's it's a request its not theyre not just curious.
Okay.
To be investigated it doesn't need to be strongly positive right.
Correct, you need to you need to provide to plan you'll need to provide an idea of how you are you.
Demonstrate that contribution of the simulation. So I think that's what we're going to do and to discuss with the FDA during the type C.
Got it and the other question is about our teeth as good data. So that you saw I think 215.
Of the 15 patients they saw two cases of Crs.
1 billion, so single dose.
And I'm wondering because your thanks for your aluminized trial, youre going to be doing higher doses and multiple cycles and I'm wondering like how do you think about the risks.
Bill you got in the trial.
Andreas can you take that question.
Yes.
And I would have to go back to the original data from France posted but.
As far as I recall this were very mild Kay.
This was of Crs, often very difficult to distinguish from unclassical infusion related reaction.
Overall, I think see sell so far has shown a remarkably good safety profile.
And of course, we will take a somewhat higher doses again, not higher doses at a test. It now as you May know our team is currently looking at four 1 billion.
NK cells per infusions per week, and we have not heard any indication of new or unexpected toxicities. So our current belief is that this approach will be very safe and that could be administered for multiple cycles.
Okay. Thank you.
Thank you.
And again one moment please for our next question.
Our next question will come from fly them, a cooler reminiscent of H C. W. Your line is open.
Thank you. This is all came from hits here and good afternoon.
Andreas.
I've been juggling between calls so I apologize if these questions have been answered before.
Just in terms of 28.
In terms of the monotherapy part of the study.
What sort of data should we expect.
I'm here to the end of the year.
In terms of the combination part of it.
Got it.
What else needs to get done.
<unk>.
Before you could start at that time.
Yeah.
I just wanted to ask you.
28, because they said also combination part of the study which is from 2008 does not have so 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 third cohort.
The study has a base here in a dose escalation design so.
We cannot predict at this point, how many dose escalations that will finally taken as we said we will provide you with updates on our progress as we go along.
During the course of the year.
No I am not sure what you mean with combination study because as far as from 2008 is concerned currently we only have six dose escalation study in our portfolio.
We said we actively look also into <unk>.
Options to combined with an NK cell.
Our strategic efforts that the company is currently undertaking without a firm protocol yet.
Yeah, Thanks, Andrew My apologies.
What I meant to us.
Your plan to see that there is.
There'll be a combination of feasible, that's what I meant and I apologize for that.
Okay.
Okay.
Andreas.
Oh, what does the combination with NK cell is feasible.
We believe its feasible based on what we have seen that.
Against the first strategic efforts that we have is to identify NK cell or a quick take forward into our <unk> from 2008 program.
Thank you thanks for taking my questions.
Thank you.
One moment please for our next question.
Our next question will come from the line of Bradley Camino of Stifel. Your line is open.
Hey, Good morning. This is John on for Brian .
Thanks for taking my question.
Another question on the FDA type C meeting is it going to require a multiple FDA meetings to get clarity on the registration.
<unk> for registration and the confirmatory strategy or do you expect to have answers for both of those after this meeting.
Okay.
Yeah. Thanks for the question as we said before the type C meeting is really focusing on the contribution of the simulations and to discuss with the agency. How we can address that best to make aluminized feasible for a registration directed study for accelerated approval. That's the focus of the type C meeting.
Now when it comes to a confirmatory study no. The confirmatory study will not be discussed at that type C meeting that will be separate.
Got it and just one more question on the.
101, <unk> poster I guess, what are the takeaways from that poster that give you confidence it will produce.
Similar effect in combination to MD Andersons NK cells.
Andreas.
I think of course, it's very early data when you look at the ask a poster with very low numbers of self but still even in patients who are coming from car T treatment, because I have seen complete and partial responses.
Our confidence is not only based on the ESCO posted but also on all of the extensive preclinical work that we have done with RG 101 cell.
Again hard to test head to head against C. M D Anderson and serve as MD Anderson. This a fresh set of product, which could not be shipped. So we were not able to run a head to head comparison, but in very comparable models arent, probably can speak more to that.
As in every models that we tested the scale, we have seen at least comparable activity compared to the data that we have.
Generated with CMT unto themselves.
Yes, just quickly quickly John this is on as Andreas said, where we when we compare kudos to pre complex.
You'll remember in vitro, we actually saw that slightly better than the pre complex thing.
And the models, we have done with Salesforce ministration, absolutely equivalents to the ones that we've done with <unk>.
<unk> Anderson.
And.
You may remember our C&D ICM.
Poster, where we again showed we have full saturation of searching on 80 101 after cryopreservation.
That also is also after cryopreservation.
Shown debs convincing while smartphone DRAM there.
Okay.
I appreciate the answers.
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.
Okay.
Okay.
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Okay.
Okay.
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