Q3 2024 Affimed NV Earnings Call & Business Update
Yeah.
Speaker Change: Good day, everyone and walk us through third quarter 2024.
Corporate update call.
Speaker Change: At this time all participants are in a listen only mode.
After the speaker's presentation, there will be a question and answer session to ask a question. During the session you will need for Starwood wanting a telephone you will then hear an automated message advisor that your Santos waste if you will.
Speaker Change: Like to remove yourself from the queue. Please press star one again.
Speaker Change: As a reminder, today's conference call is being recorded I would now like to introduce you to your host for today's call Alistair sort of.
Alistair Sort: Cheetahs head of Investor Relations at Astro Med. Please go ahead.
Speaker Change: Thank you Lisa and thank you all for joining us today for our third quarter 2020 for business and financial update call.
Speaker Change: Before we begin I'd like to remind everyone that we posted the relevant press release and presentation will be using today on the Investor Relations section of our website.
Speaker Change: On the call today, we have members of our management team, including Sean Leland, Our Chief Executive Officer, Andreas <unk>, Our Chief Medical Officer, Wolfgang Fischer, Chief Operating Officer, Denise Mueller, Chief business Officer, and Harry well not consultant Chief Financial Officer.
Financials today will be presented by our VP of finance Michael.
Speaker Change: The team will be available for Q&A after the prepared remarks.
Speaker Change: Four we start I would like to remind you that today's presentation contains projections projections and forward looking statements regarding future events. These statements represent our beliefs and assumptions only as of the date of this call except as required by law, we assume no obligation to update these forward looking statements publicly or.
Speaker Change: 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.
Speaker Change: 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 Sean Sean.
Sean Leland: Thank you for joining us today I've been with the company for a couple of months now and during this time I've had the chance to immerse myself in the incredible work that is being done at <unk>.
Sean Leland: I'm genuinely impressed by both the groundbreaking science and the clinical milestones our team has achieved over the last 12 months.
Sean Leland: The depth of expertise within our organization and the potential of our platform are truly remarkable and they have only deepened my confidence in the work that is being done at the company.
The main reason I decided to join <unk> was the data demonstrating clinical proof of concept across three different asset spanning solid tumors and hematologic malignancies.
Sean Leland: Our therapies have shown activity in both monotherapy and combination studies all of our innate cell <unk> are moving well beyond clinical proof of concept, which is having an impact on how we shape and focused the company for the future.
<unk> innovation is bringing meaningful benefits to patients who have often exhausted all other therapeutic options and indications where there are significant unmet medical needs.
Sean Leland: In addition to the promising activity as shown with RNA cell engages both as monotherapy and in combination. They have also demonstrated a favorable and differentiated safety profile, even in these challenging and heavily pretreated patient population many of whom are in the end stage of their disease.
Sean Leland: The fact that we continue to observe meaningful and often durable responses gives us immense confidence these.
Sean Leland: These results are what excites me the most about our platform and therapies, which offer hope where would all have existed before.
Sean Leland: I'd like to highlight the differentiated safety profile of our NK cell engages which enables us to target molecules with a narrow therapeutic index due to their tumor specificity.
NK cells naturally distinguished between tumor and healthy tissue. So when targeting CD 123 for instance, our engage your bonds to normal tissue, but does not trigger NK cell, killing due to inhibitory factor than healthy cells.
Sean Leland: This leads to a safer profile and improved therapeutic index for our CD 123, engage or AFM 28, compared to Tce's, Adcs and car T, which have toxicities that are often unmanageable and sometimes fatal.
Although we observed some toxicity with AFM 28, these events are fewer and manageable.
Sean Leland: This tumor specificity has also seen with ASM 24, our egfr engage or which avoids the scanner mucosal toxicities associated with other egfr targeting approaches further underscore the unique safety advantages of our NK cell engages.
Today's call will be brief as our key clinical updates will be shared in December at the upcoming Ash 2024 conference. We're excited to have an oral presentation on AFM 28, as well as preclinical data at a poster session.
Sean Leland: Data from our alumina is 203 trial will also be presented at a poster session.
Sean Leland: Clearly this recognition is based on the strength of our data. This is not only exciting it is validating that our innate cell engages may have a key role in the future paradigm.
Sean Leland: On December 17th we will host a company conference call to provide a clinical update on AFM 24.
Speaker Change: I'd like to take a moment now to reflect on what we have been doing since we last spoke.
Speaker Change: Since joining I've hit the ground running speaking with members of the financial community potential partners.
Speaker Change: And many of our clinical investigators to gain their perspective on the value they see in our therapies and how they would like to see us continue their development.
Speaker Change: I'm, taking this feedback very seriously and use it to further refine our strategy and our focus.
Speaker Change: We will maintain our focus on clinical development priorities.
Speaker Change: Our decisions about our programs will be based on clinical benchmarks, the competitive landscape and the commercial potential.
Speaker Change: Our goal going forward will be to deliver therapies that not only demonstrates strong clinical efficacy, but also have a meaningful impact on the treatment paradigm and are commercially sustainable.
In addition, we understand that partnerships will play a pivotal role in accelerating our progress drawing on my extensive background in business development, we are pursuing a wider range of potential collaborations.
Speaker Change: Broadening our thinking on the types of collaborations will allow us to engage with a more diverse set of potential partners and further expand our strategic options.
Speaker Change: <unk> today is a more streamlined and focused organization as we take our company into the future I am committed to delivering differentiated clinical data from our ongoing trials and ensuring steady measurable progress across our programs.
Speaker Change: I reiterate my commitment to improving the financial health of our company and we are actively working on it.
Speaker Change: Our financial position.
Speaker Change: My number one objective is to ensure that our company is well capitalized to deliver on the expectations. We have heard from the financial community and our investigators in order for us to continue to further the clinical development of our programs and ensure the long term success of our company. This will enable us to evolve the company such that we are not only.
Speaker Change: Not that we not only develop innovative therapies, but we operate in a way that maximizes value for all stakeholders.
Speaker Change: That includes our investors our partners and most importantly, the patients who depend upon us.
Speaker Change: With that I'll pass the call to Andreas to give you an update on our clinical progress.
Andreas: Thank you, Sean and welcome to everybody on the line.
Andreas: As Sean mentioned, our clinical update today will be brief with significant updates to come.
Andreas: F 2024 meeting in December.
Andreas: These presentations included data from our Hematological trials.
Speaker Change: Emily Lumi nice two or three so a combination trial with symptomatic and low NK cells and refractory Hodgkin lymphoma.
Speaker Change: And for Air from 28, our CD 123 targeting IC for acute myeloid leukemia.
Speaker Change: As mentioned for Egfr targeting IC area from 'twenty four.
Speaker Change: We will have a dedicated conference call to discuss the progress in the non small cell lung cancer Egfr Wild type cohort on December 17th.
Speaker Change: That said, we have made important strides across our clinical programs this quarter.
Speaker Change: I'd like to briefly highlight where we stand today.
Speaker Change: Let's start with our AFM 'twenty for one or two trial as shown on slide four.
Speaker Change: Which we are evaluating from 24 in combination with a teaser lease them up.
Speaker Change: Non small cell lung cancer patients, who have exhausted standard of care options.
Speaker Change: Bose Egfr wild type and <unk> mutant cohorts are now fully enrolled.
Speaker Change: And we are actively treating and monitoring patients.
Speaker Change: And as a reminder, we previously reported data for 17 patients from the wild type cohort at ESMO 2024.
Speaker Change: <unk> confirmed objective responses were seen one complete response and three partial responses.
In addition, eight patients achieved stable disease.
Speaker Change: Resulting in a disease control rate of 71%.
Speaker Change: Median progression free survival at that time was five nine months with a median follow up of seven four months.
Speaker Change: Importantly at the time of data cut three of four responses were ongoing for more than seven months and.
Speaker Change: All responding patients had a documented progression.
Speaker Change: <unk> and checkpoint inhibitor treatment before.
<unk> supports the hypothesis that combining area from 24 was soft tissue laser map.
Speaker Change: It may provide an alternative strategy to overcome resistance to existing therapies.
For the year from 'twenty for non small cell lung cancer Egfr mutant cohort, we presented early efficacy data on our Q2 earnings call was also four objective responses seen in the initial 17 patients.
Speaker Change: We anticipate to report the final response and safety data from the non small cell lung cancer Egfr wild type cohort.
Speaker Change: Our December 17th Company Conference call.
Speaker Change: Final PFS data from the Egfr Wild type and overall response and PFS data from the Egfr mutant cohorts are expected to be presented at a major scientific conference.
Speaker Change: First half of 2025.
Speaker Change: We believe sets of data from 24 in combination with a PD one targeting checkpoint inhibitor.
While early demonstrated promising activity in treatment refractory non small cell lung cancer patients.
Speaker Change: Potentially offering a chemotherapy free alternative for these patients.
Speaker Change: Who have failed multiple lines of treatment.
Speaker Change: Notable advantage given the difficulties these patients have and tolerating additional chemotherapy.
Moving to our a symptomatic program.
As shown on slide six.
Speaker Change: Let me now study, where we're combining allo NK and <unk> surgery targeting IC symptomatic.
Speaker Change: We are progressing this study for patients with refractory Hodgkins lymphoma.
Speaker Change: We announced that clinical data from the four cohorts, obviously run in phase <unk>.
Speaker Change: Are all fully recruited now will be presented at Ash 2024.
Speaker Change: Finally, we also announced that our air from 28th program targeting CD 123 for relapsed refractory AML will be featured in an oral presentation at ash.
Speaker Change: The ongoing phase one trial.
Speaker Change: 28, mono therapy has escalated dosing through six cohorts, reaching 300 milligrams weekly.
Speaker Change: No dose limiting toxicities have been observed at this dose level.
Speaker Change: Based on the promising monotherapy results reported during our Q2 earnings call. We have further expanded cohort six and add additional six patients two confirms the observed monotherapy signal.
Speaker Change: CX 2020 for presentation.
Speaker Change: Will feature updated data from this study.
Speaker Change: With that I'll conclude our clinical program update and now hand, it over to Michael <unk> for a review of our financials Michael Please.
Michael: Thank you rich.
And sheet and income statement highlights are shown on slides 10, and 11 of the presentation.
Michael: A quick reminder, that <unk> consolidated financial statements.
Michael: Be prepared in accordance with IRS issued by the international accounting standards Board.
Michael: Sure.
Michael: SB.
Michael: The consolidated financial statements are prepared in euros.
Michael: Since our financials are described in detail in the press release, we issued this morning I will only provide highlights on this call.
Michael: We ended the third quarter with cash cash equivalents and investment of $24 1 million euros compared to 72 million euros on December 31st.
Michael: Sure.
Michael: Based on our current operating and budget assumptions.
<unk> is our cash and cash equivalents and investments together with anticipated proceeds from the ATM program and the sale of <unk>.
Michael: Finance us into the fourth quarter of 2025.
Michael: Net cash used in operating activities for the quarter ended September 32020, before was $11 1 million euros compared to $18 3 million euros for the quarter ended September 32023.
Michael: Total revenue for the quarter ended September 32024 was <unk> two.
Michael: 2 million euros.
Michael: With 2 million for the quarter ended September 32023.
Michael: R&D expenses for the quarter ended September 32024.
Michael: $10 1 million compared to 21 5 million in 2023.
Michael: G&A expenses for the quarter ended September 32024.
Michael: 4.3.
Michael: $3 million compared to $5 4 million euros for the quarter ended September 32023.
Michael: Net loss for the quarter ended September 32024 was $15 1 million or a loss of 94 euro cents per common share compared with a net loss of $24 4 million euros or a loss of $1 63.
Michael: A common share for the quarter ended September 32023.
Sean Leland: Now I'll turn the call back to Sean for final remarks, Sean.
Sean Leland: Thank you Michael.
Sean Leland: A couple of months since I joined Athene than I've been deeply impressed by the dedication of our team and the meaningful progress we are making our.
Sean Leland: Alright therapies are treating patients who have exhausted other options and we remain committed to advancing innovative treatments that address urgent unmet needs.
Sean Leland: Looking ahead, we will focus on advancing our key clinical programs broadening partnerships and maintaining financial stability. We believe these efforts will maximize the impact of our science and create value for all stakeholders.
Despite the challenging market environment I am confident in our ability to chart. The right course forward and secure the capital needed to support our progress.
Sean Leland: I want to extend my sincere gratitude to our investors for your continued support to the patients and families who place their trust in us and to our dedicated employees, who drive our mission together, we will keep pushing forward to deliver life changing therapies.
Sean Leland: Those who need them most.
Speaker Change: For your attention and we are happy to take any questions operator.
Speaker Change: Thank you as a reminder, if you would like to ask a question. Please press star one on your telephone.
Speaker Change: Here the automated messages. Your hand is raised we also ask that you. Please wait for your name and company to be announced before you proceed with your question.
Speaker Change: Our first question for today comes from Lee.
Speaker Change: Music.
Speaker Change: Fitzgerald Your line is open.
Speaker Change: Okay, great. Thanks, guys for taking my question.
Speaker Change: Maybe just on <unk> 28.
Speaker Change: So the data update at Ash, how much do your ability should we expect.
Speaker Change: Then in terms of the patients.
Speaker Change: When you roll it into the study can you comment on the mutational status and prior treatment.
Speaker Change: Daily. Thanks for your question Andreas do you want to respond to Lee's question.
Andreas: Yeah. So.
Speaker Change: In terms of durability, obviously, we have six patients that we reported at our last earnings call. His patients will have a meaningful observation period or follow up period to really assess the durability of responses.
Speaker Change: The additional six patients that we added were.
Speaker Change: Recruited more recently.
Speaker Change: And for most of these patients some patients are still actively receiving treatment for most of the additional six patients. The follow up period. It may just be a little bit too short to have meaningful conclusions on duration of responses.
Speaker Change: In terms of Pretreat months, 80% of our patients in this trial had been pre treated with the hyper modulating agent and the network lacks a little over 50%, 55% or so had also pretreatment with an anthracycline, mainly entrust <unk> containing regimens.
Speaker Change: And I believe roughly one third of our patients had also received a stem cell transplant.
Speaker Change: In terms of mutational status, if youll look at a negative mutations like <unk>, one or <unk> 53, roughly two thirds of these patients have a negative molecular profile in terms of negative.
Speaker Change: Predicting mutations.
Okay great.
Speaker Change: And then you mentioned that.
What are you guys.
Speaker Change: Can have a monotherapy path here.
Speaker Change: I'm just curious when would you be.
Speaker Change: Fish and you go to the FDA to discuss.
Speaker Change: Registrational path here.
Speaker Change: And what will be the patient population you'll be looking at.
Speaker Change: We have other targeted agents approved here.
Speaker Change: Yes, Lee Thanks for the follow up question Andreas units.
<unk> follow up question. So I think what we announced is that.
Speaker Change: Again, we will have additional patients on the 300 milligram dose level.
Speaker Change: Protocol allows us to go even beyond the 12 patients we have now.
Speaker Change: We are also planning to add at least one higher dose cohorts to make sure that we are really capturing the full also reputed potential in terms of deepening response and response duration against the safety profile is very safe. So we easily can further dose escalate and this will give us.
Speaker Change: Dataset that would enable us to go to FDA, a little bit depending on the maturation of the data.
Speaker Change: And what was your second question.
Speaker Change: The patient population.
Speaker Change: The patient population.
Speaker Change: Again, this is a very well tolerated drug.
Speaker Change: We have not uncovered a dose limiting toxicities as a pharmacodynamic active doses like $2 5300.
Speaker Change: Also our phase one study has been open for all patients. So we have no age limitations or anything.
Speaker Change: So we expect to see patients if we go down as a mono therapy paths.
That fulfill FDA requirements for a patient population of unmet medical need so depending on agent risk profiles ISO should have received and have not responded to an anthracycline <unk> containing regimen. If they are younger fitter patients.
Or two in hyper modulating agent plus or minus for network lax regimen.
Speaker Change: Our older patients.
Patients, who have a targeted mutation like flip three or something.
Speaker Change: They should also have exhausted.
Speaker Change: Pacifically targeting therapies to be eligible and to comply with the definition of an unmet medical need population.
Speaker Change: Okay.
Speaker Change: Thank you very much.
Speaker Change: Thanks Lee.
Speaker Change: Thank you one moment for the next question.
Speaker Change: And our next question will be coming from the line of Dana Gray Bosch.
Speaker Change: Of Leerink partners. Your line is open.
Speaker Change: Hi, Thank you for another question here for me.
Speaker Change: First John I think I heard you say that you are broadening your thinking on the type of collaboration and I Wonder if we could talk about what you mean and what type of collaboration with the company pursuing previously and what does it mean, you can broaden that and then I have a follow up.
John: Yes, Dennis Thanks for the question I mean, I think kind of given the financial position of the company I mean, it makes sense too.
John: Kind of evaluate all potential options that are better on the table years. So I mean I think.
John: We're looking at a variety of different strategic partnerships that can exist. These include potential.
John: Potential.
John: Regional deals for example.
John: I think in the past.
John: Company was more so focused on Canada.
John: A finite set.
Speaker Change: <unk> was specifically looking at kind of multinational partners. So we've just broaden that strategy too.
Speaker Change: Create additional optionality to bring in additional.
Speaker Change: Non dilutive capital that could come into the company. So that's really essentially what we mean by kind of <unk>.
Speaker Change: Rodney Misko per lens on that the BD partnering front and Thats really driven by kind of leveraging kind of my past experience and relationships with companies on the business development front.
Speaker Change: Got it.
Speaker Change: No. There is just a question on ASM 'twenty or how are you thinking about potentially.
The development path going forward.
Speaker Change: Maybe similar to what leads us to ask for ASM.
Speaker Change: Will you consider.
Speaker Change: A combination like chemotherapy.
Speaker Change: Okay, PD ones and when might you make that decision.
Speaker Change: Dana Thanks for the additional follow up question Andreas do you want to respond to Dana's question.
Speaker Change: Sure.
Speaker Change: So I think all of the.
Speaker Change: The main difference between our Hematological indications like <unk>.
Speaker Change: Treatment refractory hodgkins lymphoma or treatment refractory AML or.
Speaker Change: We belief set for large indications like non small cell lung cancer. It is very unlikely to achieve regulatory approval was a single arm uncontrolled trial FDA historically have always insisted on randomized phase III trials.
Speaker Change: Currently we are.
Speaker Change: Waiting to let Cif and <unk> 24 at Liza Liza map or PD, one data mature Bruce in terms of final response rate, but also in terms of PFS.
As Youll remember, we reported a median PFS of close to six months for our initial data set in the Egfr Wild type cohort, which we believe is already quite differentiating from four to maybe four five months that you would see with standard of care.
Speaker Change: And this would give us a couple of Optionality as we could consider to takes a doublet.
Speaker Change: Into a registration trial against standard arm, which most likely would be docetaxel.
Speaker Change: Also given the very benign safety profile that we are seeing and we have patients now on trial, and then continuously drug for more than 10 or more than 12 months.
Speaker Change: We can easily also difficult triplet combinations, where we could add.
Speaker Change: VEGF inhibitor Moya tier like Remy serum up give him. So he is he proved from synergy between immune modulating therapies and VEGF inhibition or we could do.
Speaker Change: Truck like Docetaxel Tusa tablet.
Speaker Change: This would create data sets for an informed decision was to take a doublet or triplet into a registration directed trial.
Speaker Change: Great. Thank you.
Speaker Change: Thanks, Dan.
Speaker Change: Thank you one moment for the next question. Please.
Speaker Change: And our next question will be coming from Kitkat.
Speaker Change: Okay.
Sure it's Joe.
Speaker Change: Yeah.
Speaker Change: Hello, This is Alex xenakis on for PREPA.
Speaker Change: Also on April 24 can you remind us the data expectations for what type of data will be presented in December the number of patients and the durability and then also on the development strategy I believe that the company has said that we will see a presentation of additional data in the first half of 2025 do you think you'll have enough data by then to make a go no go decision.
Speaker Change: On the four development of the program.
Speaker Change: Yes, thanks for the question on behalf of the grip.
Speaker Change: Andreas do you want to respond to Alex's question.
Speaker Change: Yes.
Speaker Change: Said at our earnings call.
Speaker Change: In December.
Speaker Change: 17th of December.
Speaker Change: Our main focus will be on the Egfr wild type cohort as you know here, we targeted roughly 40 patients the quarters fully enrolled.
Speaker Change: And.
Speaker Change: What will be mature at that point will mainly be as your response a final response rate data, we expect seeing patients on trial that it will take probably another couple of months until we have final PFS data so.
Speaker Change: Response, and toxicity safety will be the main focus of our company event in December.
Speaker Change: As we said.
Speaker Change: Major PFS data for the Egfr Wild type cohort may need more time to mature or the same is true for the response data in the Egfr mutant cohorts. These patients were enrolled a little bit later and we all said we are targeting 25 patients here and also a PFS of Egfr mutant.
Speaker Change: We need more time to to really mature these states or are expected to be displayed at a major scientific conference during the first half of 2025.
Speaker Change: Okay.
Speaker Change: Thank you.
Thank you and one moment for the next question.
Our next question will be coming from the line of <unk> Wells Fargo. Your line is open.
Speaker Change: Oh, hi, thanks for taking our questions just a follow up also on ASM 24.
Speaker Change: Have you submitted the abstract for the first half of 'twenty five scientific conference and has it been accepted.
Speaker Change: I'm also wondering.
Speaker Change: In terms of the PFS data.
Speaker Change: How much more how much longer.
Speaker Change: <unk>.
The PFS need.
Speaker Change: It needed to be.
Speaker Change: Compared with the four five months or Remy cost those seats.
Speaker Change: The data to be consumed.
Speaker Change: Considered as <unk>.
Speaker Change: Strong set of data.
Speaker Change: Hey, guys.
Speaker Change: Yes. Thanks for the initial questions Andreas you want to respond to his question.
Andreas: So let's start with the last question I'm not sure whether I got the first question Felipe. So what we have reported this $5 nine months median progression free survival for the Egfr Wild type cohort for the Egfr mutant cohort, we have PFS data, but we also reported set out of C. Four responses that we have.
Andreas: And the initial 17 patients or four responses were on treatment for seven plus months, which already gives you an indication that it appears that responses that we are in using can be very durable.
Andreas: Now when you consider going into a phase III trial are one important point estimate always has a median progression free survival again here, we see probably a one and a half to two months difference, which was quite meaningful in these late line patients, but what also goes into your consideration is C C.
Andreas: We'll see a curve.
Andreas: So we know that chemotherapy, usually basically it drops down to zero in their progression free survival, because they are really long term responders to chemotherapy.
Andreas: Is different for immune modulating treatments, where you usually see a tail are often see a tail off your PFS curve, where a meaningful percentage of patients remained progression free survival.
Andreas: Progression free for prolonged period of times.
Andreas: And this will all go into your estimated hazard ratio, which basically will drive your approval.
Andreas: As I said, we wanted to let's see data from the doublet.
Andreas: Cohort mature a little bit more we believe that this may take until early probably first quarter 2025.
Then we will be in a in.
Andreas: A position to make an informed decision whether to takes a doublet directly into a registration directed trial against for example, docetaxel.
Andreas: Now the second question as far as I recall, it was whether we have submitted to the scientific conferences already.
Andreas: That would be a little bit too early most of his scientific conferences that we consider.
Andreas: For the first half of 2025 have sir.
Andreas: Abstract submission deadlines isolate December or late January. So this is a time when we are submitting that data to be presented at the first half of 2025.
Speaker Change: Thank you.
Speaker Change: Super helpful. Yeah, I was wondering also about the long tail.
Phenomenon or whether that might be possible.
Speaker Change:
Speaker Change: 24.
Speaker Change: That sounds they'll come back.
Thanks for shedding some light on that.
A quick follow up for the Hodgkin's lymphomas update.
Speaker Change: Update.
Speaker Change: What data could.
Speaker Change: We expect at Ash do you.
Could we expect to see better response rates are.
Speaker Change: CR rate.
Speaker Change: In cohorts three and four given that they had.
Speaker Change: Either number.
Speaker Change: Hey challenge Thank you.
Speaker Change: Yes, yes.
Speaker Change: Yes go ahead.
Speaker Change: Uh huh.
Speaker Change: So at Ash again, we have now fully recruited quartz all remain focus will be on the initial response rate given the fact that.
Speaker Change: Cohorts three and four are started enrollment only about like two and a half months.
Speaker Change: Go it.
Speaker Change: And as patients can receive up to three cycles. Many of these patients are still in active treatment. So that will be an early look.
At response rate, both overall response rate as well as complete response rate.
Speaker Change: Again at this point, it's hard to predict or speculate whether the increase in sales number may lead to an increase in.
Speaker Change: <unk> see.
Speaker Change: We have already seen I would say really ground breaking or paradigm changing data.
Speaker Change: These hodgkin lymphoma patients, who are triple refractory to chemotherapy PD, one and et cetera, what you would expect with any kind of standard of care or so.
Maybe 15% response rate and you're basically never see complete responses.
Speaker Change: 87% overall response rate, 50% complete response rate is already.
Speaker Change: A paradigm changing.
Speaker Change: We can talk assumption.
Speaker Change: On this.
Speaker Change: The data needed to tell.
Speaker Change: And we have not seen the final data I guess this would be really freshly prepared for Astro has the most updated data set.
Speaker Change: Great. Thanks for all the color and congrats on the progress. Thank you very much.
Thank you one moment to the next questions.
Speaker Change: Yeah.
Speaker Change: And the next question will be coming from the line of Maury Raycroft of Jefferies. Your line is open.
Speaker Change: Okay.
Speaker Change: Hi, This is on for Maury. Thank you for taking our questions two from us.
First.
Speaker Change: On ASM 'twenty for you alluded to seeking a potential partnership for 24.
Speaker Change: Where do you currently stand in terms of partnership discussions and what type of partnership do you have in mind.
Speaker Change: <unk>.
Are you thinking about full transfer after Doug or Codevelopment and I have a follow up.
Speaker Change: Yeah. Thanks for the question.
Speaker Change: So I mean, I think as I responded to the initial question from from Lee I believe.
Speaker Change: We are evaluating all kinds of strategic options. So I mean, I think we are evaluating.
Speaker Change: Multiple opportunities that could bring in potential non dilutive capital.
Speaker Change: The company.
Speaker Change: So theres not a specific type of partnership that we have in mind, we're just evaluating kind of strategic options in the context of.
Speaker Change: Other options that could be pursued that would extend the cash runway for the company.
Speaker Change: Great and a follow up on that just given the current cash.
Speaker Change: What are your thoughts on.
Speaker Change: Future prioritization potentially between ASN.
Speaker Change: <unk> 28.
Yeah. So I mean I think at this time right. We continue to develop all three programs right and barrel I mean, I think as you look across the clinical data from all three programs.
Speaker Change: Warren's continued development of all three of these programs I mean, we're showing compelling and differentiated data across all three of these programs.
Address significant unmet medical need so I mean, the prioritization at least at this time continues to remain on developing all three products in parallel.
Speaker Change: Okay very helpful. Thank you. Thanks.
Speaker Change: Thanks.
Speaker Change: Thank you next question.
Speaker Change: Our next question will be coming from the line of Lee Chen H C. Wainwright Your line is open.
Speaker Change: Hello. This is lee in for RK.
Speaker Change: Question on the center.
Speaker Change: Eight.
Speaker Change: Any thoughts on accelerating the development of the 28 program since we know that one other NK cells. So in data has been.
It has now advanced into phase two in frontline AML.
Speaker Change: It's your co development strategy for 2008 to be in frontline or in.
Speaker Change: Hum later lying in combination with art and T cells.
Speaker Change: Thanks for the question Andreas do you want to respond to these questions.
Yeah. So.
Andreas: We set a cycle it was previously.
Andreas: We do see a good monotherapy signal again, it was a relatively small number of patients. The first step now is to really consolidate this monotherapy signal.
Andreas: Both in terms of response rate and duration of responses.
Andreas: Let's say if you stay with a response rate of 50% and show a meaningful duration of responses, which in this refractory patients could be probably four months or longer four to six months given the effects of the overall survival expectancy for these refractory patients often is only four months all of this.
Give us an option to go an accelerated approval path.
Andreas: This accelerated approval paths would be based on a single arm phase two study and by definition would have to be conducted in later lines. So in patients with unmet medical need and.
Basically no treatment options available.
Andreas: We are aware of the other NK cell engaged or all of this has just started phase one probably early phase two in combination it was a hyper modulating agent and network connects all.
Andreas: This is a much longer pathway a few for sure would you need a randomized phase three study.
Andreas: Which can be very expensive could also be quite costly so our preferred strategy or would it be to evaluate at least initially an accelerated approval strategy and later lines of AML.
Speaker Change: Yes, thanks for the color maybe a follow up on that so previously you mentioned combining if in 2008 with no therapy can you comment on the pros and cons of engineered NK cells versus car NK cells, which will be the.
Speaker Change: Preferred candidates that if you're considering going combo strategy. Thank you.
Speaker Change: Yeah. So I mean from all the data that we have seen with simpler make in combination with allogeneic NK cells.
Speaker Change: Combining <unk> from 2008 was an allogeneic NK cell product is a very logical choice.
Speaker Change: And here, we seem to see even more single agent activity remember it seemed to make in Hodgkin lymphoma, only produces 15% responses and still when you add the yellow NK cells, you end up in the 80% to 90% response range, we would expect to see a similar shift a similar increase in activity.
Speaker Change: T.
Speaker Change: If we would add Hello, NK cells and here, we are looking at different options.
Speaker Change: Two to pursue an NK cell based program.
Speaker Change: I would not agree it was a statement that car in case, our preferred over a combination of an IC engine free or low NK product.
Speaker Change: Engineered car NK, so usually are much more difficult to produce often associated with significantly higher CMC costs, what we have shown with the MD Anderson trial.
Speaker Change: What we seem to show now with our Liberty Nice trial is that we can be at least as active.
Speaker Change: Yes.
Speaker Change: Engineered car NK was a combination which is easier to produce.
Speaker Change: Probably much cheaper to produce and we can also use the different components independently of each other.
Speaker Change: We have shown an MD Anderson for example is the effect is not only driven by the infused.
Speaker Change: Generic NK cell, but sets or the ability to be a free ICU like we do at aluminite and with like we have done and see MD. Anderson trial also can recruit patients own NK cells. So you have to do.
Speaker Change: We will attack with the patient's own NK cells and T. Transfused allogeneic NK cells against some things that you cannot do it was a car NK.
Speaker Change: So I would turn the argument raws around I'm, sorry, if you can go with IC and the non engineered easily and cheaply to produce allo NK product sets prefer it over a much more complicated car NK construct.
Alastair Sort: Okay, Thanks, Florida Alastair.
Alastair Sort: Thank you.
Alastair Sort: One moment for the next questions.
Speaker Change: And our next question will be coming from the line of Allison.
Speaker Change: Laidlaw and company your line is open.
Speaker Change: Good morning, and thanks for taking the question.
Speaker Change: Just trying to follow up with the previous one a little bit on the.
<unk> 28.
First one is that.
Speaker Change: Should you.
Speaker Change: Should the next cohort also.
Speaker Change: Sure robust activities in the U S. You mentioned that you were equal accelerated approval path.
How should we think about the overall potentially over a size the study size for that and any colors on that.
Speaker Change: Potentially sort of pivotal study for salary past did not have a follow up.
Speaker Change: Yeah. Thanks for the question Andreas do you want to speak to your question.
Andreas: Yeah sure.
Speaker Change: Accelerated approval always will depend of course on your effect size.
Speaker Change: Given what we have seen so far and again if this signals foothold it up we have some experience in discussions with FDA on our.
Speaker Change: Symptomatic program, where we also talked about accelerated approval.
Speaker Change: I would say what FDA, usually wants to see an accelerated approval trial would be if we can.
Speaker Change: C population somewhere between 80, and probably 100 patients as.
Speaker Change: I do want to see some dose finding studies, which we are already conducting to really be able to judge on the dose effect relationship.
Speaker Change: And so I think that is a fair estimate of how a trial and accelerated approval trial would have to look like.
Speaker Change: Okay, Great and maybe just one more question here, which is if we compare.
Speaker Change: And 'twenty a versus 13.
Speaker Change: C at least at this stages.
Speaker Change: When the <unk> seems to have actually very robust.
Speaker Change: Uh huh.
Speaker Change: Results without adding additional NK cells. So.
Was there any.
Speaker Change: Fundamental differences between <unk>.
Speaker Change: 2013 in terms of.
The product the drug itself or design itself maybe rendered.
Speaker Change: <unk> has so.
Speaker Change: So sort of a more <unk>.
Speaker Change: More problems very promising outcomes at this moment.
Speaker Change: So thanks for the follow up question, Yeah, Andreas maybe you want to answer a follow up question.
Speaker Change: That was a very difficult question.
Speaker Change: What we currently believe that honestly, we see higher activity signals that we are seeing in AML.
Speaker Change: May not be.
Speaker Change: Significantly associated.
Speaker Change: The molecule, we believe AFM 13 into F. 'twenty eight even though they are chemically are little bit different.
Speaker Change: So it can be in a smaller molecule with a somewhat shorter half life.
Speaker Change: We believe both of them are very potent and very capable to activate the innate immune system and to target.
Speaker Change: NK cells.
Speaker Change: I think the main difference and why we'd see some higher single agent activity from 2008 is due to the underlying disease.
Speaker Change: If you look at data from non targeted NK cells, so without any antibody tests the NK cell.
Speaker Change: Consistently in AML, you have seen even with non targeted NK cell response rates.
Speaker Change: 'twenty, probably even up to 30% range, whereas in lymphoma. If you have not a non targeted NK. So you rarely see any responses.
Speaker Change: So what we think is set AML cells.
Speaker Change: Can be are seem to be more susceptible to NK cell mediated killing in general.
Speaker Change: We also think that AML patients may have.
Speaker Change: Still a little higher levels of a patients own or intrinsic NK cells. So that we can activate with our I C. E. We know from Hodgkin lymphoma patients for example that they basically have no.
Speaker Change: Real functional NK cells at least the ones they are in very advanced stages.
Speaker Change: So I think it's more a difference in the.
Speaker Change: Underlying biology as it makes AML, specifically sensitive for NK cell mediated killing them and Thats why we believe that both a monotherapy development could it be possible for you from 2008 and for sure.
Speaker Change: From 2008, NK cell based combination should yield even better results.
Speaker Change: Great that's a great insight and thanks and congrats on the progress so far.
Speaker Change: Thank you.
Speaker Change: If you would like to ask a question. Please press star one on your telephone.
Speaker Change: And our next question will be coming from the line of Dara <unk>.
Speaker Change: Stifel. Your line is open.
Speaker Change: Alright, Thank you Dara is out here or rock.
Speaker Change: On <unk> 24 based on your experience with this mechanism.
Speaker Change: How can maturation of or confirmation of a final or are by your and inform us on the quality of <unk>.
Speaker Change: Final PFS come in next year and to clarify here will we get PFS on all 40 patients.
Speaker Change: First half of 'twenty five.
Speaker Change: Or will there be some excluded patients.
I have a follow up after that yeah, Arizona. Thanks for the question Andreas Q&A responded Arizona question.
Speaker Change: Yeah, so the focus as well.
Speaker Change: Set on those with December.
Speaker Change: Data disclosure will be on response rate simply because I always think that PFS data are not mature at this point.
Speaker Change: As many patients are still on active treatment.
Response rate is one important parameter for decision, making so it will move.
Speaker Change: Zinc confirmed our belief that we are able to basically break a PD, one or PDL, one resistance by as a dual combination which would be reflected in a high response rate or in a high rate of patients with significant tumor volume reduction against the mature PFS data, which.
Speaker Change: <unk> drives the final decision probably do in the first half of 2025.
Speaker Change: Again PFS in a in a non randomized trial is.
Speaker Change: It's an interesting endpoint, but.
Speaker Change: Later, you can report PFS data probably is a bit of the data are so we just have to wait until these states are really mature.
And.
Not sure whether I got.
Speaker Change: There was a second part of the question was.
Yes, 40 patients will we get PFS from all 40 patients or will there be some exclude a patient.
Speaker Change: Yes, it's all protocols you have of course definitions of what constitutes a patient who is eligible for Sip protocol.
Speaker Change: I would expect that we will see a PFS data from over 40 patients with <unk>.
Speaker Change: May not see response data from over 40 patients as you usually have a one two or three patients dropping out.
Speaker Change: For the fuzzy.
Speaker Change: Feature of missing a second scan, but all of these patients would it be included until the PFS analysis.
Speaker Change: Okay.
Sean Leland: Thanks for the commentary and Sean you talked about broadening the scope for BD partnering.
Speaker Change: What do you think is required at this time in terms of signal generation or.
Speaker Change: Approval path clarity.
Speaker Change: For from a potential partner.
Speaker Change: Yeah rich.
Speaker Change: Molecule there because I think it's different for each program.
Speaker Change: Yeah, and actually that was my question to two.
Speaker Change: To try to understand what you are prioritizing in your pipeline for potential BD.
Speaker Change: Opportunities.
Speaker Change: Maybe lead with that and.
Speaker Change: And let us know please on.
What is the next step.
Speaker Change: As far as what you are trying to do.
Speaker Change: Generate and present to a potential partner to get the ball rolling.
Speaker Change: Yeah. So I mean, I think as I've shared in response to the partnering questions I mean I think.
Speaker Change: We are open to discussing partnerships around.
Speaker Change: Any of our innate cell engage your programs. So I mean I think.
Speaker Change: We are open to having discussions on the three clinical stage assets as well as you know.
Speaker Change: Preclinical program that we have in the pipeline as well as in a potential target discovery partnerships as well. So I mean, I think there is a multitude of partnering options.
Speaker Change: Exist across the portfolio I mean, I think I get the impression at least that your question is geared more towards the clinical stage assets.
Speaker Change: And I mean, I think partners have indicated a variety of different things I mean, I think what we've heard from the vast majority of folks is.
We're looking to see a bit more mature data and I think you know as.
Andreas has highlighted the progress across the clinical pipeline I think you know.
Speaker Change: The indications that we've received from potential partners is that we are likely approaching data sets that have kind of.
Speaker Change: The maturity as well as the size in terms of number of patients that theyre looking to see to gain confidence and more seriously entertain.
Speaker Change: Potential partnerships. So that's where we are at this stage in terms of discussions.
Understood. Thank you.
Speaker Change: Thanks.
Speaker Change: Thank you and at this time there are no additional questions in the queue.
Speaker Change: We would like to thank everyone for participating in today's conference call. You may all disconnect and have a good day.
Speaker Change: Yeah.
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