Q1 2024 Affimed NV Earnings Call & Business Update
Okay.
Operator: Good day everyone, and welcome to Affimed's first quarter 2024 earnings and corporate update call. At this time, all participants are in a listen-only mode. Later we will conduct a question and answer session, and instructions will be given at that time. As a reminder, today's conference call is being recorded. I would now like to introduce your host for today's call, Alex Vodakis, Head of Investor Relations at Affimed. Please go ahead. Thank you.
Unknown Executive: Good day, everyone, and welcome to Affimed's first quarter 2024 earnings and corporate update call.
Speaker Change: Good day, everyone and welcome to <unk> first quarter 2024 earnings and corporate update call. At this time all participants are in a listen only mode. Later, we will conduct a question and answer session and instructions will be given at that time.
Unknown Executive: At this time, all participants are on listen-only mode. Later, we will conduct the question-and-answer session, and instructions will be given at that time. As a reminder, today's conference call is being recorded.
Speaker Change: A reminder, today's conference call is being recorded.
Alexander Fudukidis: I would like to introduce your host for today's call, Alex Fudukis. Head of Investor Relations at Affimed, please go ahead.
Alexander Fudukidis: I would like to introduce your host for todays call Alex <unk> head of Investor Relations at Astro Med. Please go ahead.
Alexander Fudukidis: Thank you, Michelle, and thank you all for joining us today for our first quarter 2024 update call. Before we begin, I'd like to remind everyone that we issued the relevant press release and presentation on our website today, which you can find under the Investor Relations section. On the call today, we have members of our management team, including Andreas Harstrick, our Chief Medical Officer, and Acting Chief Executive Officer; Wolfgang Fischer, our Chief Operating Officer; Denise Mueller, our Chief Business Officer; and Harry Weltsman, our consultant Chief Financial Officer.
Alexander Fudukidis: Thank you, Michelle. And thank you all for joining us today for our first quarter 2024 update call. Before we begin, I'd like to remind everyone that we issued the relevant press release and presentation on our website today, which you can find in the investor relations section. On the call today, we have members of our management team, including Andreas Harstrick, our Chief Medical Officer and Acting Chief Executive Officer, Wolfgang Fischer, our Chief Operating Officer, Denise Mueller, our Chief Business Officer, and Harry Weltman, our Consulting Chief Financial Officer.
Michelle and thank you all for joining us today for our first quarter 2024 update call before we begin I'd like to remind everyone that we issued the relevant press release and presentation on our website today, which you can find them to be in the Investor Relations section on the call today, we have members of our management.
Alexander Fudukidis: [noise] team, including on draft hard strike, our Chief Medical Officer, and acting Chief Executive Officer, Wolfgang Fischer Chief operating officer.
Alexander Fudukidis: Denise Mueller Chief business Officer, and Harry Walton, our consulting Chief Financial Officer, our financials today will be presented by our Vice President of Finance Michael Walsh.
Alexander Fudukidis: Our financials today will be presented by our Vice President of Finance, Michael Wolfe. The team will be available for Q&A after the prepared remarks. Before we start, I would like to remind you that today's presentation contains projections and forward-looking statements regarding future events. These statements represent our beliefs and assumptions only as of the date of this call. Except as required by law, we assume no obligation to update these forward-looking statements publicly, or to update the reasons why actual results could differ materially from those anticipated in the future. The forward-looking statements, even if new information becomes, a very wonderful future.
Speaker Change: The team will be available for Q&A. After the prepared remarks before we start I would like to remind you that today's presentation contains projections and forward looking statements regarding future events.
Alexander Fudukidis: Our financials today will be presented by our Vice President of Finance, Michael Wolf. The team will be available for Q&A after the prepared remarks. Before we start, I would like to remind you that today's presentation contains projections and forward-looking statements regarding future events. These statements represent our beliefs and assumptions only as of the date of this call. Except as required by law, we assume no obligation to update these forward-looking statements publicly or to update the reasons why actual results could differ materially from those anticipated in the future in the forward-looking statements, even if new information becomes available in the future.
Speaker Change: 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 to update the reasons why actual results could differ materially from those anticipated in the future and the forward looking statements even if.
Alexander Fudukidis: These forward-looking statements are subject to risks and uncertainties, and actual results may differ materially from those expressed or implied in these statements due to various factors, including but not limited to those identified under the section entitled risk factors and our filings with the SEC and those identified under the section entitled forward-looking statements and the press release that we issued today and filed with the SEC.
Speaker Change: New information becomes available in the future.
Alexander Fudukidis: These forward-looking statements are subject to risks and uncertainties, and actual results may differ materially from those expressed or implied in these statements due to various factors, including but not limited to those identified under the section entitled "Risk Factors," and our filings with the SEC, and those identified under the section entitled "Forward-Looking Statements," and the press release that we issued today, and filed with the SEC.
Speaker Change: These forward looking statements are subject to risks and uncertainties and actual results may differ materially from those expressed or implied in these statements due to various factors, including but not limited to those identified under the section entitled risk factors in our filings with the SEC and those identify.
Speaker Change: Under the section entitled forward looking statements in the press release that we issued today and filed with the SEC.
Alexander Fudukidis: With that, I'll turn the call over to Andreas. Okay, Andreas?
Andreas Harstrick: With that, I'll turn the call over to Andreas.
Andreas Harstrick: Andreas? Yeah, thank you, Alex, and good day, everyone, and thank you for joining us today for our first quarter 2024 earnings call. I'm excited to share with you today clinical data on all three of our clinical programs that, as we believe, are validating our approach of using the innate immune system as an additional tool to fight cancer. When we announced this strategic reorganization of Affirmet, and our focus on the advancement of our clinical assets in January, we guided that our goal would be to generate meaningful data for all three programs in the first half of the year.
Speaker Change: That I will turn the call over to Andreas Andreas.
Andreas Harstrick: Yeah, thank you, Alex. And good day, everyone.
Andreas Harstrick: Yeah. Thank you Alex and good day, everyone and thank you all for joining us today.
Andreas Harstrick: And thank you for joining us today for our first quarter 2024 earnings. I'm excited to share with you today clinical data on all three of our clinical programs, which we believe are validating our approach of using the innate immune system as an additional tool to fight cancer. When we announced the strategic reorganization of Affimed and our focus on the advancement of our clinical assets in January, we stated that our goal would be to generate meaningful data for all three programs in the first half of the year.
Speaker Change: First quarter 2024 earnings call.
Andreas: I'm excited to share with you today clinical data on all three of our clinical programs.
Andreas: As we believe are validating our approach of using the innate immune system as an additional tool to fight cancer.
Speaker Change: When we announced the strategic reorganization of alphabet.
Speaker Change: Our focus on the advancement of our clinical assets in January.
Speaker Change: We guided to is that our goal would be to generate meaningful data for all three programs in the first half of the year.
Andreas Harstrick: I'm proud to say and thankful to all of my core workers at Affirmet, and to all our clinical investigators that today we can deliver on this guidance. As shown on slide three, we now have clinical validation for all three assets. For AFM24, we are advancing the combination study with a T-Soliza map in treatment refractory patients with non-small cell lung cancer. Bows in the each of our wide-type and in the each of our mutant subgroups. Data that we shared at ASCO demonstrate durable responses in patients with each of our wide-type tumors, with three of our responses ongoing now for over seven months.
Andreas Harstrick: I'm proud to say and thankful to all of my co-workers at Affimed and to all our clinical investigators that today we can deliver on this guidance. As shown on slide three, we now have clinical validation for all three aspects. For AFM24, we are advancing the combination study with tesolizumab in treatment-refractory patients with non-small cell lung cancer, both in the EGFR wild type and in the EGFR mutant subgroups. Data that we shared at ASCO demonstrate durable responses in patients with EGFR-wide type tumors, with three or four responses ongoing now for over seven months. We also see meaningful and confirmed tumor responses in the EGFR Mutants subgroup, a tumor type that is generally considered unresponsive to immunotherapy.
Speaker Change: I'm proud to say and thankful to all of my coworkers at halfway met and to all of our clinical investigators.
Speaker Change: Today, we can deliver on this guidance.
Speaker Change: As shown on slide three.
Speaker Change: We now have clinical validation for all three assets.
Speaker Change: For air from 'twenty four we are advancing the combination study with a T. So Lisa map in treatment refractory patients.
Speaker Change: With non small cell lung cancer.
Speaker Change: Both Egfr wild type and it was egfr mutant subgroups.
Speaker Change: Data that we shared at ESCO demonstrate durable responses in.
Speaker Change: In patients with Egfr wild type tumors.
Speaker Change: With three or four responses ongoing now for over seven months.
Andreas Harstrick: We also see meaningful and confirmed tumor responses in each of our mutant subgroups, a tumor type that is generally considered unresponsive to immunotherapy.
Speaker Change: We also see meaningful and confirmed tumor responses in <unk>.
Jeff: Jeff how Newton subgroup, a tumor type that is generally considered unresponsive to immunotherapy.
Andreas Harstrick: We can also share exciting data for our clinical LUMINIZE trial of symptomatic therapy in combination with LO and K cells in patients with refractory Hodgkin's lymphoma. Seven patients have had their CT scans meanwhile assessed by blinded independent read, which will be the primary endpoint of the study as agreed upon with FDA. In these patients, we see objective responses in six out of seven patients, for an overall response rate of 85.7 percent. Importantly, this includes four patients who have complete remission. Finally, AFM28, our CD123 targeting ICE for the treatment of refractory AML, has shown remarkable clinical activity.
Andreas Harstrick: We can also share exciting data for our clinical luminous trial of a symptomic in combination with LO and K cells, in patients with refractory hotschkins lymphoma. Seven patients have had their PT scans, CT scans, meanwhile assessed by blinded independent read, which will be the primary endpoint of society as a great upon with FDA. In these patients, we see objective responses in six out of seven patients for an overall response rate of 85.7%. Importantly, this includes four patients with a complete remission.
Speaker Change: We can also share exciting data for our clinical aluminized trial of symptomatic in combination with allo NK cells in patients with refractory Hodgkins lymphoma.
Speaker Change: Several patients have had their P. T S kits C. T scans. Meanwhile, assessed by blinded independent REIT.
Speaker Change: Which will be as a primary endpoint of study as agreed upon with FDA.
Speaker Change: And these patients we see objective responses in six out of seven patients for an overall response rate of 85, 7%.
Speaker Change: Importantly, this includes four patients with complete remission.
Andreas Harstrick: Finally, AFM28, our CD123 targeting IC for the treatment of refractory AML, has shown remarkable clinical activity. At those level five of our single agent dose escalation study, we have observed one complete response and five patients with stable disease. At those level six, we see two patients with a complete response and the CRI, respectively, and three patients with stable disease. Importantly, the complete response from those level five is now ongoing and stable for more than five months. And five of the six patients at those level six are continuing on treatment with a possibility for further deepening of their responses.
Speaker Change: Finally from 28, our CD 123 targeting IC for the treatment of refractory AML has shown remarkable clinical activity.
Andreas Harstrick: At dose level five of our single agent dose escalation study, we observed one complete response in five patients with stable disease; at dose level six, we see two patients with a complete response and a CRI, respectively, and three patients with stable disease. Importantly, the complete response from dose level 5 is now ongoing and stable for more than 5 months, and five of the six patients at dose level 6 are continuing treatment with the possibility of further deepening of their response.
Speaker Change: At dose level five of our single agent dose escalation study.
Speaker Change: We have observed one complete response and five patients with stable disease.
Speaker Change: At dose level six we see two patients with a complete response and a cri respectively.
Speaker Change: And three patients with stable disease.
Speaker Change: Importantly, the complete response from dose level five is now ongoing and stable for more than five months and.
Speaker Change: In five of six patients at dose level six are continuing on treatment was a possibility for further deepening of their responses.
Andreas Harstrick: Also importantly, no dose-limiting toxicities were observed at dose levels 5 and 6, thereby establishing a safe and effective regimen for further development. Let us look at the data in some more detail. Today, I will start with a symptom. As a reminder, on slide five, you see the trial design as agreed upon with FDA. We now have...
Andreas Harstrick: Also, importantly, no dose-limiting toxicities were observed. In those level five and six, thereby establishing a safe and effective regimen for further development.
Speaker Change: Also importantly, no dose limiting toxicities were observed.
Speaker Change: Didn't dose level five and six.
Speaker Change: Thereby establishing a safe.
Speaker Change: And effective regimen for further development.
Andreas Harstrick: Let us look at the data in some more detail. Today, I will start with a symptomic. The reminder on slide five, you see the trial design as the greater point with FDA. We now have completed enrollment into Courts one and two, and are actively recruiting Courts three and four. We admit that there is still a slight delay in recruitment compared to our initial expectations, as discussed on our last earnings call. This is mainly due to a higher rate of patient drop-out during the screening period. However, with additional sites now active and more experience, was a protocol at the site level, we expect to see further improvement in patient recruitment and the reduction in the dropout.
Speaker Change: Let us look at fee.
Speaker Change: Data in some more detail.
Speaker Change: Today, I will start with symptomatic.
Speaker Change: As a reminder, on slide five.
Speaker Change: You'll see the trial design as agreed upon with FDA.
Speaker Change: We now have.
Andreas Harstrick: We have completed enrollments into courts one and two and are actively recruiting cohorts three and four. We admit that there is still a slight delay in recruitment compared to our initial expectations, as discussed on our last earnings call. This is mainly due to a higher rate of patient dropout during the screening period. However, with additional sites now active and more experience with the protocol at the site level, we expect to see further improvement in patient recruitment and a reduction in the dropout rate. In terms of safety, as shown on slide six.
Speaker Change: Completed enrollment into cohorts, one and two.
Speaker Change: And are actively recruiting cohorts three and four.
Speaker Change: We admit that there are still a slight delay in recruitment compared to our initial expectations.
Speaker Change: As discussed on our last earnings call.
Speaker Change: This is mainly due to a higher rate of patient dropouts during the screening period.
Speaker Change: However, with additional sites now active and more experience was a protocol at the site level, we expect to see further improvement in patient recruitment and a reduction in its a dropout rate.
Andreas Harstrick: Ray. In terms of safety, shown on slide six, the adverse event profile is inline with our previous experience, with a symptomic and the combination of a symptomic and allergenic and case health respectively. This important to note that in the luminous to us reached study, we did not use steroids as part of the pre-medication for a symptomic, and therefore we were expecting a slightly higher rate of infusion-related reactions compared to some studies with a symptomic in which steroid pre-medication was routinely used. Four of seven patients developed a great one or two infusion-related reactions/CRS event. One of those four patients had a fourth lasting great three CRS, as assessed by the investigator, which manifested mainly by high fever and a decrease in blood pressure; however, the patient responded readily to standard of care treatment.
Speaker Change: In terms of safety shown on slide six.
Andreas Harstrick: The adverse event profile is in line with our previous experience with symptomatic and the combination of symptomatic and allogeneic and case cells, respectively. It is important to note that in the Luminize 203 study, we did not use steroids as part of the premedication for symptomatic patients, and therefore, we were expecting a slightly higher rate of infusion-related reactions compared to some studies with symptomatic patients in which steroid premedication was routinely used.
Speaker Change: The adverse event profile is in line with our previous experience with symptomatic and the combination of symptomatic and allogeneic NK cells respectively.
Speaker Change: This is important to note that Illumina is two or three study we did not use steroids as part of the Premier education for a symptomatic and therefore, we were expecting a slightly higher rate of infusion related reactions.
Speaker Change: Compared to some studies with symptomatic in which steroid premedication boost routinely used.
Andreas Harstrick: Four of seven patients developed a grade one or two infusion-related reaction-slash-CRS event. One of these four patients had a short-lasting grade 3 CRS, as assessed by the investigator, which manifested mainly by high fever and a decrease in blood pressure. However, the patient responded readily to standard of care treatment.
Speaker Change: Four of seven patients developed a great one or two infusion related reactions slash Crs event.
Speaker Change: One of these four patients had a short lasting grade three crs.
Speaker Change: As assessed by the investigator.
Speaker Change: Which manifested mainly by high fever, and a decrease in blood pressure.
Speaker Change: As a patient responded ready lead to standard of care treatment.
Andreas Harstrick: Importantly, in this patient, shortly after this event, there was also an acute CMV infection diagnosed. Thus, the relative contribution of the infusion of a symptomatic versus an acute CMV infection to the overall symptoms is not clear.
Andreas Harstrick: Importantly, in this patient, thoughtly after this event, there was also an acute CMV infection diagnosed, and thus the relative contribution of the infusion of a symptomic versus acute CMV infection to the overall symptoms is not clear. Importantly, there were no treatment discontinuations due to side effects of a symptomatic or yellow and K. Also, there were no instances of bleeding, eye cancer, or graft versus host disease. As a clinical activity of the combination is, I think remarkable as shown on site 7. Six of seven patients showed an objective response by independent read, including four patients was a complete remission.
Speaker Change: Importantly in this patient shortly after this event.
Speaker Change: There was also an acute CMV infection diagnosed and thus the relative contribution of the infusion of symptomatic versus acute CMV infection to the overall symptoms is not clear.
Andreas Harstrick: Importantly, there were no treatment discontinuations due to side effects of the Symptomic OR-LNK. Also, there were no instances of bleeding, Eikens, or graft-versus-host disease. And the clinical activity of the combination is, I think, remarkable, as shown on slide 7. Six of seven patients showed an objective response by independent reading, including four patients with a complete remission. These data are directly comparable with the data that were reported by MD Anderson Cancer Center for symptomatic NK cell therapy in combination with fresh pre-complexed NK cells and thus indicate that co-administration of an ICE with allogeneic and K-cells is active, that no pre-complexing is needed, and that cryopreserved NK cells seem to be comparable to fresh NK cells in terms of antitumor activity.
Speaker Change: Importantly, there were no treatment discontinuation due to side effects.
Speaker Change: Of the symptomatic or allo NK.
Speaker Change: Also as there were no instances of bleeding.
Speaker Change: <unk> or graft versus host disease.
Speaker Change: As the clinical activity of the combination is I think remarkable as shown on slide seven.
Six of seven patients showed an objective response by independent REIT.
Speaker Change: Including four patients with a complete remission.
Andreas Harstrick: These data are directly comparable with data that were reported by MD Anderson Cancer Center for a symptomic in combination with fresh pre-context and K cells. And thus indicate that co-administration of an ICE was allergenic and K cells is active, that no pre-contexting is needed and that cryopreserved and K cells seem to be comparable to fresh and K cells in terms of anti-tomerectivity. Also, this results demonstrate that data from the single-site study at MD Anderson are reproducible in a multisenter setting, as these seven patients were enrolled by four different institutions. As slide eight shows, the patient's characteristics underscore that these patients are heavily pre-treated, with a median of four lines of previous therapy.
Speaker Change: These data are directly comparable with the data set were reported by MD Anderson cancer Center for the symptomatic in combination with fresh pre complex NK cells.
Speaker Change: And thus indicate that co administration of an ICU with allogeneic NK cells is active.
Speaker Change: But no pre complexing as needed and said cryo preserved NK cells seem to be comparable to fresh NK cells in terms of antitumor activity.
Andreas Harstrick: Also, these results demonstrate that data from the single-site study at MD Anderson are reproducible in a multi-center setting, as these seven patients were enrolled by four different institutions. Slide eight shows the patients' characteristics, underscoring that these patients are heavily pre-treated with a median of four lines of previous therapy. All patients had failed combination chemotherapy, PD-1 Targeting Therapy, and Brent Taksimis. In addition, five of seven patients also failed after otologous stem cell transplants.
Speaker Change: Also as these results demonstrate set data from the single site study at MD Anderson, a reproducible in a multicenter setting.
Speaker Change: These seven patients were enrolled by four different institutions.
Speaker Change: Slide eight shows the patient's characteristics underscoring that these patients are heavily pretreated with a median of four lines of previous therapy.
Andreas Harstrick: All patients had failed combination chemotherapy, PD1 targeting therapy, and Brentaxi map. In addition, five of seven patients had also failed after autologoses stem such transplants.
Speaker Change: All patients had failed combination chemotherapy.
Speaker Change: PD, one targeting therapy and Brent taxi map.
Speaker Change: In addition, five of seven patients had also failed after autologous stem cell transplant.
Andreas Harstrick: On slide nine, you'll see an example of a patient with multiple manifestations of his refractory Hodgkin's lymphoma, including axillary lymph nodes, supraclavicular lymph nodes, spleen, and inguinal lymph nodes. The patient had failed all standard of care options, including a stem cell transplant, and presented with B symptoms, which clinically is a very unfavorable As you can see, all tumor manifestations resolved after only one cycle of therapy. Now, we move on to AFM 24.
Andreas Harstrick: On slide nine, and you'll see an example of a patient with multiple manifestations of his refractory hotscins lymphoma, including auxiliary lymph nodes, superclavicular lymph nodes, spleen, and ingredients. notes. The patient had failed all standard of care options, including stem cell transplant, and presented with B symptoms, which clinically is a very unfavorable prognostic factor. As you can see, all human manifestations resolved after only one cycle of therapy.
Speaker Change: On slide nine Youll see.
Speaker Change: An example of a patient with multiple manifestations officer refractory Hodgkins lymphoma <unk>.
Speaker Change: Including axillary lymph nodes supraclavicular lymph nodes spleen and ingredients notes.
Speaker Change: <unk> had failed all standard of care options, including stem cell transplant and presented with be symptoms, which clinically it's a very unfavorable prognostic factor.
Speaker Change: As you can see all tumor manifestations resolved after only one cycle of therapy.
Andreas Harstrick: Let's move on to Affim24. Since we presented the data in detail during our ASCO presentation, I will be brief here. As shown on slide 11, the combination of Affim24, that is a laser map, has meaningful activity in patients with heavily protruded, either of a white type, non-smots or lung cancer. In 15 available patients, there were four objective responses and eight patients with stable disease. Of note, all patients had failed combination chemotherapy and PD-1 targeting therapy. All responders were documented progressive on previous anti-PD-1 treatments. Importantly, the responses and the tumor control induced by Affim24 at the laser map appeared to be durable, as shown on slide 12, where you see the long-term follow-up data.
Speaker Change: Let's move on to <unk> 24.
Andreas Harstrick: Since we presented the data in detail during our ASCO presentation, I will be brief here. As shown on slide 11, the combination of AFM24 and atezolizumab has meaningful activity in patients with heavily pretreated EGFR-Y type non-small cell lung cancer. In 15 evaluable patients, there were four objective responses and eight patients with stable disease. Of note, all patients had failed combination chemotherapy and PD-1 targeting therapy. All responders were documented to be progressing on previous NTPD1 treatments.
Speaker Change: Since we presented the data in detail during our ESCO presentation I will be brief here.
Speaker Change: A slowdown shown on slide 11, it's a combination of air from 24, and it is Elisa map has meaningful activity in patients with heavily pretreated Egfr wild type non small cell lung cancer.
Speaker Change: In 15, Evaluable patients there were four objective responses in eight patients with stable disease.
Speaker Change: Of note all patients had failed combination chemotherapy and PD one targeting therapy.
Speaker Change: Our responders were documented progressive on previous anti PD one treatment.
Andreas Harstrick: Importantly, the responses and the tumor control induced by AFM24IT Zolizumab appear to be durable, as shown on slide 12, where you see the long-term follow-up date. The progression-free survival for the whole study population is 5.9 months, which compares favorably to the 4.5 months which is usually achieved in these patients with standard of care treatment. Even more encouraging is the fact that three of the four remissions are still ongoing, now at more than seven, more than eight, and more than nine months respectively. It appears very unlikely that these data can be explained by tesolizumab activity alone.
Importantly, so responses and so tumor control induced by half from 24 at Liza Liza mapped appear to be durable as shown on slide 12.
Speaker Change: Where you see the long term follow up data.
Andreas Harstrick: The progression free survival for the whole study population is 5.9 months, which compares favorably to the 4.5 months, which is usually achieved in these patients with standard of care treatment. Even more encouraging is the fact that three of the four emissions are still ongoing, now at more than seven, more than eight, and more than nine months, respectively. It appears very unlikely that these data can be explained by a t-zolizema activity alone. Even though their occasional responses to PD-1 reach challenge after intervening chemotherapy, PFS data in these patients have been very short. Even in PD-1 non-pre-treated patients, in platinum refractory non-smokers or lung cancer, a t-zolizema has shown a progression free survival interval of only 2.8 months.
So progression free survival for the whole study population is five nine months, which compares favorably to the four five months, which is usually achieved in these patients with standard of care treatment.
Speaker Change: Even more encouraging is the fact that streamer, obviously for emissions are still ongoing now at more than seven more than eight and more than nine months respectively.
Speaker Change: It appears very unlikely that these data can be explained by Tcl is a map activity alone.
Andreas Harstrick: Even though there are occasional responses to PD-1 re-challenge after intervening chemotherapy, PFS data in these patients have been very short. Even in PD-1 non-pretreated patients with platinum-refractory non-small cell lung cancer, tesolizumab has shown a progression-free survival interval of only 2.8 months. Our recent results in patients with heavily pretreated EGFR mutant non-small cell lung cancer, as shown on slide 13, support the activity of the AFM24-artesolizumab combination. In 13 patients that are response-evaluable, four responses and six patients with stable disease were achieved. Compared to the data that was reported at ASCO, meanwhile, all objective responses have been confirmed by follow-up scans, and all responses are ongoing.
Speaker Change: Even though there are occasional responsive to PD, one re challenge after intervening chemotherapy.
Speaker Change: PFS data in these patients has been very short.
Speaker Change: Even in PD, one non pretreated patients in platinum refractory non small cell lung cancer.
Speaker Change: These are lease them up has shown a progression free survival interval of only two eight months.
Andreas Harstrick: Our recent results in patients with heavily pre-treated immune non-smokers or lung cancer, as shown on slide 13, support the activity of the Affim24 at the laser map combination. In certain patients that are responsive, valuable, four responses and six patients with stable disease were achieved. Compared to the data that reported at ASCO, meanwhile, all objective responses have been confirmed by follow-up scans, and all responses are ongoing. This is remarkable as EGF-A mutant non-smots or lung cancer is in general regarded as unresponsive to immunotherapy.
Speaker Change: Our recent results in patients with heavily pre treated egfr mutant non small cell lung cancer as shown on slide 13 supports the activity of <unk> from 24 at Liza Liza map combination.
Speaker Change: In researching patients had a response evaluable for responses and six patients with stable disease were achieved.
Speaker Change: Compared to the data that we reported at Ash scope. Meanwhile, all objective responses has been confirmed by follow up scans.
Speaker Change: And all responses are ongoing.
Andreas Harstrick: This is remarkable as EGFR mutant non-small cell lung cancer is in general regarded as unresponsive to immunotherapy. Slide 14 shows the market opportunity for drugs that are targeting refractory non-small cell lung cancer. In the seven major markets, there are 175,000 patients with EGFR wild-type non-small cell lung cancer and roughly 35,000 patients with EGFR mutant non-small cell lung cancer annually who fail standard of care therapy and will need additional treatment
Speaker Change: This is remarkable as egfr mutant non small cell lung cancer is in generally regarded as unresponsive to immunotherapy.
Andreas Harstrick: Slide 14 shows the market opportunity for drugs that are targeting refractory non-smokers or lung cancer. In the seven major markets, there are 175,000 patients with EGF-A white type non-smots or lung cancer, and roughly 35,000 patients with EGF-A mutant non-smots or lung cancer annually, who fail standard of care therapy and will need additional treatment options. Current treatment options for these patients are unsatisfactory, with PFS durations around 4 to 4.5 months. Also, many salvage regimens include chemotherapy that is often difficult to tolerate for these heavily pre-treated patients. The combination of Affim 24 plus PD-1 could provide a chemotherapy-free alternative with meaningful activity and significantly better tolerability for these patients.
Speaker Change: Slide 14 shows the market opportunity for drugs that are targeting refractory non small cell lung cancer.
And the seven major markets there are 175000 patients.
Speaker Change: With Egfr wild type non small cell lung cancer, and roughly 35000 patients with Egfr mutant non small cell lung cancer annually, who fail standard of care therapy and will need additional treatment options.
Andreas Harstrick: Current treatment options for these patients are unsatisfactory, with PFS durations around 4 to 4.5 months. Also, many salvage regimens include chemotherapy that is often difficult to tolerate for this heavily pretreated patient. The combination of AFM24 plus PD-1 could provide a chemotherapy-free alternative with meaningful activity and significantly better tolerability for these patients. Finally, let's review the most recent data for AFM28.
Speaker Change: Current treatment options for these patients are unsatisfactory with PFS durations around four to four five months.
Also many salvage regimens include chemotherapy.
Speaker Change: That is also difficult to tolerate for this heavily pretreated patients.
Speaker Change: The combination of higher from 294, plus PD, one could provide a chemotherapy free alternative with meaningful activity and significantly better tolerability for these patients.
Andreas Harstrick: Finally, let's review the most recent data of Affim 28. Our CD-123 targeting ICE for the treatment of acute mildly leukemia, as shown on slide 16. Here we have escalated C-dose through 6 cohorts up to 300 milligrams weekly. I think the study is also a good example of the ability of our organization to execute clinical studies. The first patient in this program was treated in March 2023, and the whole dose of test-calation trial over 6 cohorts was executed in only 15 months.
Speaker Change: Finally, let's review the most recent data of <unk> 28.
Andreas Harstrick: Our CD123 targeting ICE for the treatment of acute myeloid leukemia, as shown on slide 16. Here, we have escalated the dose through six cohorts up to 300 milligrams weekly. I think this study is also a good example of the ability of our organization to conduct clinical studies.
Speaker Change: Our CD 123 targeting ice's for the treatment of acute myeloid leukemia.
Speaker Change: Shown on slide 16.
Speaker Change: Here, we have escalated see dose so six cohorts up to 300 milligrams weekly.
Speaker Change: I think the study is also a good example, I'll see ability of our organization to execute clinical studies.
Andreas Harstrick: The first patient in this program was treated in March 2023, and the whole dose escalation trial over six cohorts was completed in only 15 months. The safety profile is shown on slide 16. For dose levels 5 and 6, we did not see any dose-limiting toxicity. The most frequent side effects were infusion-related reactions, mainly of low grade. Only three patients had a grade two infusion-related reaction, responding in all cases to symptomatic treatment, and there were no grade three or higher IRR. One patient experienced short-lasting self-limiting CRS of grade one. Infections are characteristic manifestations of acute leukemia and were seen in half of the patients. However, none of the infections were considered treatment-related by the investigators.
Speaker Change: So the first patient in this program was treated in March 2023 and four.
Speaker Change: The whole dose escalation trial over six cohorts was executed in only 15 months.
Andreas Harstrick: The safety profile is shown on Slide 16. For those levels 5 and 6, we did not see any dose-limiting toxicities. The most frequent side effects were in funeral-related reactions, mainly of low grade. Only three patients had a grade 2 in funeral-related reaction, responding in all cases to symptomatic treatment, and there were no grades 3 or higher IRRs. One patient experienced short limiting, short lasting self-limiting CRS of grade 1. Infections are characteristic manifestations of acute leukemia, and were seen in half of the patients. However, none of the infections was considered treatment-related by the investigators. In addition, we observed meaningful target interaction at doses of 200 milligrams and above, with nearly a complete saturation of CD-123 binding sites on the tumors, and occupation levels of CD-16A on the NK cells that include preclinical experiments result in potent NK cell activation.
Speaker Change: So safety profile as shown on slide 16.
Speaker Change: For those of US five and six we did not see any dose limiting toxicities.
Speaker Change: The most frequent side effects, where infusion related reactions.
Speaker Change: Mainly of low grade.
Speaker Change: Only three patients had a great two infusion related reaction responding in all cases to symptomatic treatment and there were no grade three or higher IRR.
Speaker Change: One patient experienced a short limiting short lasting self limiting crs of great one.
Speaker Change: Infections are characteristic manifestations of acute leukemia and were seen in half of the patients.
Speaker Change: However, none of the infections was considered treatment related by the investigators.
Andreas Harstrick: In addition, we observed meaningful target interaction at doses of 200 mg and above, with near complete saturation of CD123 binding sites on the tumors and occupancy levels of CD16A on the NK cells that, in preclinical experiments, resulted in potent NK cell activation. The clinical activity is displayed on slide 17. At dose level five, we saw one complete response and five patients with stable disease. All patients were heavily pre-treated.
Speaker Change: In addition, we observed meaningful target interaction at doses of 200 milligrams into buff with near complete saturation of CD 123 binding sites on the tumors and occupation levels of CD 16, <unk> NK cells that improved preclinical experiments result in <unk>.
Speaker Change: <unk> NK cell activation.
Andreas Harstrick: The clinical activity is displayed on slide 17. In those levels 5, we saw one complete response, and 5 patients were stable disease. All patients were heavily pre-treated. Of notes, the complete remission is still ongoing after more than 5 months. In those levels 6, we saw 2 patients with a complete response in the CRI, respectively, and 3 patients with stable disease. 5 patients from those levels 6 remain on treatment with additional cycles, and thus with the option to deepen their responses. I think these results are remarkable. Most of these patients with advanced AML have very low numbers of their own NK cells when they start treatment.
The clinical activity of Steves played on slide 17.
Steves: In dose level five we saw one complete response and five patients with stable disease or.
Steves: All patients were heavily pre treated.
Andreas Harstrick: Of note, the complete remission is still ongoing after more than five months. In dose level six, we saw two patients with a complete response and a CRI, respectively, and three patients with stable disease. Five patients from dose level six remain on treatment with additional cycles, and that was the option to deepen their response. I think these results are remarkable.
Steves: Of note the complete remission is still ongoing after more than five months.
Speaker Change: And dose level six we saw two patients with a complete response at the Cri respectively.
Speaker Change: And three patients with stable disease.
Speaker Change: Five patients from dose level six remain on treatment was additional cycles and.
Speaker Change: <unk> was the option to deepen their responses.
Speaker Change: I think these results are remarkable.
Andreas Harstrick: Most of these patients with advanced AML have very low numbers of O and K cells when they start treatment, so it appears that AML could be very sensitive to NK cell-mediated killing if there are already low numbers of endogenous NK cells. When directed to the leukemia cells by AFM28, it can produce a complete response. These data, taken together with the impressive activities that we have seen with a combination of the symptomatic and allogeneic NK cells in Hodgkin lymphoma, support our strategic intent to pursue further development of AFM28, in association with a cryopreserved allergenic and case of product.
Speaker Change: Most of these patients with advanced AML.
Speaker Change: Very low numbers of own NK cells, when they start treatment.
Andreas Harstrick: So, it appears that AML could be very sensitive to NK cell mediated killing if already low numbers of endogenous NK cells. When directed to the leukemia of cells by AFM-28, can produce complete responses. These data, taken together with the impressive activities that we have seen, was a combination of a symptomic and allergenic and case cells in Hodgkin lymphoma, support our strategic intent to pursue further development of AFM-28 in association with a cryo-preserved allergenic and case cell product. With this, we would again address an area of significant unmet medical need.
Speaker Change: So it appears that AML could be very sensitive to NK cell mediated, killing if already low numbers of endogenous NK cells.
Speaker Change: When directed to the leukemia cells by half from 28 can produce complete responses.
Speaker Change: These data taken together was impressive activities that we have seen was a combination of a symptom make an allogeneic NK cells in Hodgkin lymphoma.
Speaker Change: Support our strategic intent to pursue further development of <unk> 28.
Speaker Change: In association with our cryo preserved allogeneic NK cell product.
Andreas Harstrick: And we would again address an area of significant unmet medical need. In the seven major markets, we see over 14,000 patients per year who fail at least two lines of standard therapy and require a new treatment option. Many of these patients are elderly and show frequent comorbidities, thus limiting the use of aggressive chemotherapy. However, immunotherapy has not been successful so far in AML. A treatment approach based on the activation of the innate immune system could therefore be an important additional strategy for the treatment of these patients. With this, I will close the overview of our clinical programs and hand over to Michael Wolf for a review of our financial data. Michael, please.
Speaker Change: With this.
Speaker Change: And we can address an area of significant unmet medical need.
Andreas Harstrick: In the seven major markets, we see over 14,000 patients per year who fail at least two lines of immunotherapy and require a new treatment option. Many of these patients are elderly and show frequent comorbidities, thus limiting the use of aggressive chemotherapy. Immunotherapy has not been successful so far in AML. A treatment approach based on the activation of the innate immune system could, therefore, be an important additional strategy for the treatment of these patients.
Speaker Change: In the seven major markets, we see over 14000 patients per year.
Speaker Change: Who failed at least two lines of standard therapy and require a new treatment option.
Speaker Change: Many of these patients are elderly and show frequent co Morbidities Saar.
Speaker Change: Thus limiting the use of aggressive chemotherapy.
Speaker Change: Immunotherapy has not been successful so far in AML.
Speaker Change: A treatment approach based on the activation of innate immune system could sell for being an important additional strategy for the treatment of these patients.
Michael Wolfe: With this, I will close the overview of our clinical programs and hand over to Michael Wolfe for a review of our financial data.
Speaker Change: With this I will close the overview of our clinical programs and hand over to Michael Wolff.
Michael Wolf: A review of our financial data Michael Please.
Michael Wolfe: Michael, please. Thank you, Andreas. Balance sheet and income statement highlights are shown on slides 20 and 21 of the presentation. A quick reminder that Affimed's consolidated financial statements has been prepared in accordance with IFRS as issued by the International Accounting Standards Board or IASB. The consolidated financial statements are prepared in euros. Since our financials are described in detail in the press release, we shoot this morning.
Michael Wolf: Thank you Andreas.
Michael Wolf: Balance sheet and income statement highlights are shown on slides 20 and 21 of the presentation. A quick reminder that Affimed's consolidated financial statements have been prepared in accordance with IFRS as issued by the International Accounting Standard Board or IASB. The consolidated financial statements are prepared in euros. Since our financials are described in detail in the press release issued this morning, I will only provide highlights on this call. We ended the first quarter with cash equivalents and investments of €48.5 million, compared to €72 million on December 31, 2023.
Michael Wolf: Balance sheet and income statement highlights are shown on slide 20, and 21 of the presentation.
Michael Wolf: A quick reminder, that automates consolidated financial statements have been prepared in accordance with IRS has issued.
Michael Wolf: International Accounting standard board or Asps.
Michael Wolf: SP.
Michael Wolf: The consolidated financial statements are prepared in euros since our financials are described in detail in the press release.
Michael Wolfe: I will only provide highlights on this call. We ended the first quarter with cash, cash equivalent and investments of 48.5 million euros compared to 72 million euros on December 31, 2023. Based on our current operating and financing plan, we anticipate that our liquidity will support operations each of the second half of 2025. Net cash used in operating activities for the quarter and at March 31, 2024, was 23.8 million euros compared to 33.2 million euros for the quarter and at March 31, 2023. Total revenue for the quarter ended March 31, 2024, was 0.2 million euros compared with 4.5 million euros for the quarter ended March 31, 2023.
Michael Wolf: This morning, I will only provide highlights on this call.
Michael Wolf: We ended the first quarter with cash cash equivalents and investments of 44 to $8 5 million euros compared to 72 million on December 31 2023.
Michael Wolf: Based on our current operating and financing plan, we anticipate that our liquidity will support operations into the second half of 2025. Net cash used in operating activities for the quarter ended March 31st, 2024 was €23.8 million compared to €33.2 million for the quarter ended March 31st, 2023. Total revenue for the quarter ended March 31st, 2024 was 0.2 million euros compared with 4.5 million euros for the quarter ended March 31st, 2023. The net loss for the quarter ended March 31st, 2024 was 19.2 million euros compared with a net loss of 32 million euros for the quarter ended March 31st, 2020. Now I'll turn the call back to Andreas for final remarks. Okay, Andreas?
Michael Wolf: Based on our current operating and financing plan, we anticipate that our liquidity will support operations into the second half of 2025.
Michael Wolf: Net cash used in operating activities for the quarter ended March 31, 2024 was $23 8 million euros compared to $33 2 million euros for the quarter ended March 31 2023.
Michael Wolf: Total revenue for the quarter ended March 31, 2024 was <unk> 2 million euros, compared with $4 5 million euros for the quarter ended March 31 2023.
Michael Wolfe: Net loss for the quarter ended March 31, 2024, was 19.2 million euros compared with the net loss of 32 million euros for the quarter ended March 31, 2023.
Michael Wolf: Net loss for the quarter ended March 31, 2024 was $19 2 million euros compared with a net loss of 32 million euros for the quarter ended March 31 2023.
Andreas Harstrick: Now I will turn the call back to Andreas for final remarks. Andreas? Yeah, thank you, Michael.
Michael Wolf: Now I'll turn the call back to Andre for final remarks addressed.
Andreas Harstrick: Yeah, thank you, Michael. For our concluding remarks, let's go to slide 22. I think this has been a very exciting and very successful quarter for Affimed, in which we were able to obtain clinical validation for all three of our programs. I think the strongest conclusion that we can draw from this data today is consistency. When you see a single data set in one study in one particular disease setting, of course, you may always think, could this be a chance finding?
Andre: Yeah. Thank you Michael.
Andreas Harstrick: For our concluding remarks, let's go to Slide 22. I think this has been a very exciting and very successful quarter for Affimed in which we were able to obtain clinical validation of all three of our programs. I think the strongest conclusions that we draw from this data today is consistency. When you see a single data set in one study, in one particular disease setting, of course you may always think, could this be a chance finding. But what we are demonstrating today is consistent activity signals across three different programs that are all designed to leverage the power of the innate immune system to fight cancer.
Andre: For our concluding remarks, let's go to slide 22.
Speaker Change: I think this has been a very exciting and very successful quarter for <unk> and <unk>.
Andre: Which we were able to drop chain clinical validation of all three of our program.
Speaker Change: I think the strongest conclusions that we draw from this data today is consistency.
Speaker Change: When you see a single dataset in one study in one particular disease setting.
Speaker Change: Cost you may always think could this be a chance finding.
Andreas Harstrick: But what we are demonstrating today is consistent activity signals across three different programs that are all designed to leverage the power of the innate immune system to fight cancer. We see this in four different indications and with two different combinations.
Speaker Change: But what we are demonstrating today is consistent activity signals.
Speaker Change: <unk> three different programs that are already signed to leverage the power of innate immune system.
Andreas Harstrick: We see this in four different indications and with two different combinations. Initial results from our asymptomic and LLNK program show remarkable activity, which seemed to be on par with the data reported by MD Anderson. The difference is that we were able to generate this data with co-administration of CIC and CNK cell and with prior preserve of CIC and K cells. Both factors set and able the use of this approach in the real world multi-center setting. For AML, we see that AFM28 can induce responses even in a setting where only very few K cells are available to fight leukemia.
Speaker Change: To fight cancer.
Speaker Change: We see this in four different indications and risk to different combinations.
Andreas Harstrick: Initial results from our Asymptomik and LONK programs show remarkable activity, which seems to be on par with the data reported by MD Anderson. The difference is that we were able to generate these data with co-administration of the ICE and the NK cell and cryopreserved off-the-shelf NK cell, both factors that enable the use of this approach in a real-world multi-center setting. For AML, we see that AFM28 can induce responses even in a setting where only very few NK cells are available to fight leukemia.
Speaker Change: Initial results from our a symptomatic and Allo NK program show remarkable activity.
Speaker Change: Which seem to be on par with the data reported by MTN.
Speaker Change: The difference is that we were able to generate six data.
Speaker Change: With co administration of <unk> NK cell.
Speaker Change: <unk> cryo preserved off see shelf NK cells.
Speaker Change: Those factors set enables the use of this approach in the real world Multicenter setting.
Speaker Change: For AML, we seize at AFM 28 can use can induce responses.
Speaker Change #100: Even in a setting where only very few NK cells are available to fight leukemia.
Andreas Harstrick: I think it is very reasonable to expect a boost in activity of sufficient amounts of active allergenic and K cells are added, as we have shown in our lumenized study. Therefore, we are actively exploring ways to continue the AFM28 program in combination with officer shelf, allergenic, and K cells. And last but not least, we see consistent activity for the combination of AFM24 and ETC. The strategies that utilizes the crosstalk between the adaptive and the innate immune system. When we started this program, I think there were a lot of doubts whether the innate immune system could even attack solid tumors given the largely immunosuppressive environment that has been found in many solid tumors.
Andreas Harstrick: I think it is very reasonable to expect a boost in activity if sufficient amounts of active allogeneic and K-cells are added, as we have shown in our Luminae study. Therefore, we are actively exploring ways to continue the AFM28 program in combination with off-the-shelf allogeneic encases.
Speaker Change #101: I think it is very reasonable to expect a boost in activity of sufficient amounts of active allogeneic NK cells are added.
Speaker Change #101: Shown in our alumina study.
Speaker Change #101: Therefore, we are actively exploring ways to continue to hear from 28 program in combination with off the shelf Allergan ache NK cells.
Speaker Change #102: And last but not least.
Andreas Harstrick: We see consistent activity for the combination of AFM24 and etisolizumab, a strategy that utilizes crosstalk between the adaptive and the innate immune system. When we started this program, I think there were a lot of doubts about whether the innate immune system could even attack solid tumors, given the largely immunosuppressive environment that is found in many solid tumors. Meanwhile, we have demonstrated objective and durable responses in heavily pre-treated EGFR-White type non-small cell lung cancer patients, with the longest response now ongoing for 10 months, in patients with prior documented progression on PD-1 targeting therapy.
Speaker Change #102: We see consistent activity for the combination of AFM 'twenty, four and Itchy Silesia map the.
Speaker Change #103: The strategies that utilizes the cross talk between the adapt defensive innate immune system.
Speaker Change #103: When we started this program essentially out of a lot of doubts.
Speaker Change #103: Whereas our innate immune system could even attack solid tumors, given the largely immunosuppressive environment that is found in many solid tumors.
Andreas Harstrick: Meanwhile, we have demonstrated objective and durable responses in heavily pre-treated EGF-a-wide type non-smulsive lung cancer patients, with the longest response now ongoing for 10 months in patients with prior documented progression on PD-1 targeting therapy. The data is supported by the observation of objective and confirmed responses in patients with heavily pre-treated EGF-a-mutant non-smulsive lung cancer. A disease that historically has not been sensitive to immune-mediated treatments. Of note, we see these results with a regimen that does not include any chemotherapy. And thus, maybe better tolerated in these heavily pre-treated patients.
Speaker Change #104: Meanwhile, we have demonstrated objective and durable responses in heavily pre treated egfr wild type non small cell lung cancer patients.
Speaker Change #104: With the longest response no ongoing for 10 months.
Speaker Change #104: In patients with prior documented progression on PD, one targeting therapy.
Andreas Harstrick: This data is supported by the observation of objective and confirmed responses in patients with heavily pre-treated EGFR mutant non-small cell lung cancer, a disease that historically has not been sensitive to immune-mediated treatment. Of note, we see these results with a regimen that does not include any chemotherapy, and thus may be better tolerated in these heavily pre-treated patient populations. I think the totality of the data reported today support our strong belief that the innate immune system can be utilized to fight multiple types of hematological and solid tumors and that Affimed's Propriety ICE molecules can provide the necessary targeting and activation.
Speaker Change #105: This data supported by your observation of objective.
Speaker Change #106: And confirmed responses in patients with heavily pre treated egfr mutant non small cell lung cancer.
Speaker Change #106: The disease that historically has not been sensitive to immune mediated treatments.
Speaker Change #106: Of note do we see as these results was a regimen that does not include any chemotherapy and.
Speaker Change #106: <unk> may be better tolerated in these heavily pre treated patient population.
Andreas Harstrick: Congratulations. I think the totality of the data reported today supports our strong belief that the innate immune system can be utilized to fight multiple types of hematological and solid tumors. And that Affimed's propriety is immolicules can provide the necessary targeting and activation. As guided, we will have additional important data readouts in the course of the year. Affimed was its portfolio of several potent and KSL engages, and was its experienced and highly motivated clinical development organization, is well suited to advance the use of the innate immune system as an initial additional treatment option for patients in need.
Speaker Change #106: I think the totality of the data.
Speaker Change #107: Today support our strong belief that innate immune system can be utilized to fight multiple types of hematological and solid tumors.
Speaker Change #107: And that I assume that's proper Iot IC molecules can provides the necessary targeting and activation.
Andreas Harstrick: As guided, we will have additional important data readouts in the course of the year. affimed with its portfolio of several potent and case-selling gauges. And with its experienced and highly motivated clinical development organization, it's well suited to advance the use of the innate immune system as an additional treatment option for patients in need. We will continue our path to advance these exciting programs and thereby bring value to our organization, our patients, and our shareholders. With this, I thank you all for your attention, and I'm happy to take questions. Operator, please.
Speaker Change #108: As guided we will have additional important data readouts in the course of the year.
Speaker Change #109: A few met with its portfolio of several potent NK cell engages.
Speaker Change #110: And was it experienced and highly motivated clinical development organization.
Speaker Change #110: I'll ask you to advance the use of innate immune system.
Speaker Change #111: An initial additional treatment option for patients in need.
Andreas Harstrick: We will continue our past to advance these exciting programs and thereby bring value to our organization, our patients, and our shareholders.
Speaker Change #111: We will continue our path to advance these exciting programs and thereby bring value to our organization our patients and our shareholders.
Andreas Harstrick: With this, I thank you all for your attention, and I'm happy to take questions.
Speaker Change #112: With this I. Thank you all for your attention.
Unknown Executive: Operator, please. Thank you.
Speaker Change #112: And I'm happy to take questions operator please.
Unknown Executive: If you'd like to ask a question, please press Star 11. If your question has been answered and you'd like to remove yourself in the queue, please press star 111 again.
Speaker Change #113: Thank you if you'd like to ask a question. Please press star one one.
Speaker Change #114: If your question has been answered and you'd like to remove yourself from the queue. Please press star one again.
Srikripa Devarakonda: Our first question comes from Crypto Devaricanda with two of the securities. Your line is open. Hey guys, thank you so much for taking my questions, and congrats on all the progress across the three assets you have.
Operator: Thank you. If you'd like to ask a question, please press star 1 1. If your question has been answered and you would like to remove yourself from the queue, please press star 1 again. Our first question comes from Srikripa Devarakonda on tourist security. Your line is open.
Clipper condo: Our first question comes from Clipper condo, What's your Securities. Your line is open.
Srikripa Devarakonda: Hey, guys. Thank you so much for taking my questions and congratulations on all the progress across the three assets you have. So I have a question about Luminize. You mentioned that cohorts one and two were enrolled. Our assumption is that that's 12 patients. We saw data from seven patients today. I know you said you were going to see updates later. Just wanted to get clarification on the remaining five patients.
Speaker Change #116: Hey, guys. Thank you so much for taking my questions and congrats on all the progress.
Speaker Change #117: Across the three assets you have.
Andreas Harstrick: So I have a question about Lumenize. You know, you talked; you mentioned that cohorts 1 and 2 were enrolled. Our assumption is that that's 12 patients. We saw data from seven patients today. I know you said you were going to see updates later. Just wanted to get clarification on the remaining five patients. Have they not reached the first scan, which, if I remember correctly, is seven weeks? And when we see the next update, you know, will we get durability data or have a sense of the longest duration of follow-up? Thank you.
Speaker Change #118: I have a question about aluminized Chuck.
Speaker Change #117: <unk>.
Speaker Change #119: You mentioned that cohorts, one and two where Android.
Speaker Change #120: Our assumption is that that's well patients we saw data from seven patients today. I know you said you were going to see updates later just wanted to get clarification on the remaining five patients have been not reached the first scan, which if I remember correctly seven weeks.
Srikripa Devarakonda: Have they not reached the first scan, which, if I remember correctly, is seven weeks? And when we see the next update, will we get durability data or have a sense of the longest duration of follow-up? Thank you. Yeah, thank you, Kripa, for your...
Speaker Change #121: And when we see the next update will we get durability data or have a sense of the longest duration of follow up thank you.
Andreas Harstrick: Thank you, Crypto, for your question. So first, your conclusions, right? We have included 12 patients in cohorts 1 and 2. So they are filled. We are actively recruiting cohorts 3 and 4 now. The reason why we have not shown the data of the remaining five patients simply, as we mentioned, is that we initially had a certain delay in recruitment. So these patients are in the middle of their treatments, their first cycle. As you rightfully say, we have our first assessment on roughly week seven, week eight. Now what you also reported today is that we want all PET CT scans to be evaluated by blind and independent read, which is the FDA prescribed final endpoints.
Andreas Harstrick: Yeah. Thank you, Kripa, for your question. So first, your conclusion is right. We have included 12 patients in cohorts one and two, so they are full. We are actively recruiting cohorts three and four now. The reason why we have not shown the data for the remaining five patients is, as we mentioned, that we initially had a certain delay in recruitment. So these patients are in the middle of their treatment, their first cycle.
Speaker Change #121: Yes. Thank you Chris for your question. So first your conclusion is right. We have included 12 patients in cohorts one and two so they are filled we are actively recruiting cohorts three and four now.
Speaker Change #122: The reason why we have not shown the data of the remaining five patients simply as as we mentioned that.
Speaker Change #122: We initially had a certain delay in recruitment. So these patients are in the middle of their treatment their first cycle.
Andreas Harstrick: As you rightfully say, we have our first assessment at roughly week seven or week eight. Now, what we also reported today is that we want all PET CT scans to be evaluated by blind and independent readers, which is the FDA prescribed final endpoint. So we wanted to make sure that the data will really be consistent with the data sets that may go to FDA. This may add another two to three weeks before you have your independent final readout.
Speaker Change #122: As you rightfully say, we have our first assessment on a roughly week seven week eight now what we also reported today is set we want all our pet city scans to be evaluated by blinded independent REIT.
Speaker Change #123: Which gives the FDA prescribed a final endpoints. So we wanted to make sure that data will really be consistent with the data sets that may go to FDA. This may add another two to three weeks before you have your independent final readout data.
Andreas Harstrick: So we wanted to make sure that data will really be consistent with the data sets that may go to FDA. This may add another two to three weeks before you have your independent final readout data. So we will have the data of these 12 patients are definitely in queue three. The question of follow-up, of course, is always when are the first patients treated. Again, we will have follow-up data, of course, of these 12 patients, but realizing that some of these patients have recently been entered. The first follow-up will probably be like three, four, five months follow-up.
Andreas Harstrick: So we will definitely have the dates of these 12 patients definitely in Q3. The question of follow-up, of course, is always, when will the first patients be treated? Again, we will have follow-up data, of course, of these 12 patients, but realizing that some of these patients have recently been entered, the first follow-up will probably be like 3, 4, 5 months later. Again, not due to the fact that we expect a lot of relapses, but simply because patients have not been on treatment for longer. So if you want to have a real long-term follow-up where patients have the chance to be
Speaker Change #123: So we will have the data of these 12 patients are definitely in Q3.
Speaker Change #124: The question of follow up of course is always when ours the first patients treated.
Speaker Change #124: Again, we will have a follow up data of course of these 12 patients, but realizing that some of these patients have recently entered the first follow up will probably be like 345 months follow up.
Unknown Executive: Again, not due to the fact that we expect a lot of relapses, but simply patients have not been on treatment for longer. So if you want to have a real long-term follow-up, where patients have the chance to be a year or so on this protocol, this probably will more be towards the end of the year. Okay.
Speaker Change #124: Not due to the fact that we expect a lot of relapses, but simply patients have not been on treatment for longer.
Speaker Change #125: If you wanted to have a real long term follow up where patients have the chance to be a year or so on this protocol. So it's probably more towards the end of CEO.
Unknown Executive: Thank you so much.
Speaker Change #126: Great. Thank you so much.
Unknown Executive: Thank you.
Daina Graybosch: And our next question comes from Daina Graybosch with Learning Partners; your line is open. Yeah, a question for me too on Luminize203, Andre. I wonder if you could talk about what was driving the screen failures drop out. I just wonder if there's any implications of that for the type of patients that could be treated by this going forward. And yeah, let's take that. Yeah, that's a great question, and we spend quite some time investigating what happened. I think there is still some training on the sides because physicians may have been over eagerly to enroll patients.
Daina Michelle Graybosch: And our next question comes from Daina Graybosch with Lyric Partners. Your line is open.
Speaker Change #126: Thank you.
And our next question comes from Dana <unk> with Leerink Partners. Your line is open.
Andreas Harstrick: Yeah, a question for me, too, on Luminize 203, Andreas. I wonder if you could talk about what was driving the screen failures dropout. I just wonder if there are any implications of that for the type of patients that could be treated by this going forward. And yeah, let's take that.
Speaker Change #126: Yeah.
Dana <unk>: For me to Unlimber nice luxury I Wonder if you could talk about.
Speaker Change #128: What's driving the screen failure and drop out.
Speaker Change #128: Wonder if there's any implications of that or the type of patients that can be created by that going forward.
Speaker Change #129: And with.
Andreas Harstrick: Yeah, that's a great question, and we spent quite some time investigating what happened. I think there is still some training on the sites because physicians may have been over-eager to enroll patients. So we had a couple of patients entered who initially looked like they would fulfill all inclusion criteria. Then, after review, we found out that, for example, one patient had no previous atezolizumab treatment. One patient did not receive PD-1 treatment. Additionally, one patient had a documented allergic reaction to CD3 targeting treatments.
Speaker Change #129: With that.
Speaker Change #129: Yeah.
Speaker Change #130: That's a great question and we spent quite some time investigating what happened.
Speaker Change #131: There is.
Speaker Change #132: Still some.
Training on the sites because.
Speaker Change #132: Physicians may have been all over it could lead to enroll patients. So we had a couple of patients entered.
Andreas Harstrick: So we had a couple of patients entered. Initially, looked like they would fulfill all inclusion criteria. Then after review, we found out that, for example, one patient had no previous at use a little brand taxi map treatment. One patient did not have a PD One treatment. One patient had a documented allergic reaction to CD3-targeting treatment. Then we have seen a couple of patients. Again, these are very sick patients. Work wide viral infections. I believe we have two patients with an intervening COVID infection that made them drop out. And in fact, we had one or two patients who were throwing informed consent when they considered significant commuting distances.
Speaker Change #133: Initially looked like I say would fulfill all inclusion criteria then after our review we found out that for example, one patient had no previous it is a little brand taxi mab treatment. One patient did not have a PD one treatment one patient had a documented allergic reaction to Cds III targeting.
Andreas Harstrick: Then we have seen a couple of patients, again these are very sick patients, who acquired viral infections. I believe we had two patients with an intervening COVID infection that made them drop out. And in fact, we had one or two patients who withdrew informed consent when they considered significant commuting distances. Again, we only have like 10 sites open.
Speaker Change #133: Treatment.
Speaker Change #134: Then we have seen a couple of patients again these are very sick patients.
Speaker Change #135: Required viral infections delivered to patients with an integrated and Covid infection.
Speaker Change #136: That made them drop out and in fact, we had one or two patients who withdraw informed consent when they considered.
Speaker Change #137: Significant commuting distance is again, we only have like 10 sites open so for some patients in the U S. There is still a very significant commuting involved to participate in this trial.
Andreas Harstrick: Again, we only have like 10 sites open. So, for some patients in the US, there is still a very significant commuting involved to participate in this trial. With more training on the trial side, I think, at least, we will see a reduction in patients who are not fulfilling all inclusion criteria. With more sites active, we can reduce the commuting issues. I think the third issue patients with Hodgkin's lymphoma with four or five previous treatments are more prone to virus infections. So we may still see some patients who acquire intermittent comorbidities or intermittent diseases while in the screening period.
Andreas Harstrick: So for some patients in the US, there is still a very significant amount of commuting involved to participate. With more training on the trial side, I think at least we will see a reduction in patients who are not fulfilling all inclusion criteria. With more sites active, we can reduce the commuting issues, I think. The third issue is that patients with Hodgkin's lymphoma with four or five previous treatments are more prone to virus infection. So we may still see some patients who acquire intermittent comorbidities or intermittent diseases while in the study.
Speaker Change #138: With more training on the <unk> side I think at least we will see a reduction in patients.
Speaker Change #138: Patients who are not fulfilling all inclusion criteria.
Speaker Change #139: With more sites active we can reduce the commuting issues I think.
Speaker Change #139: The third issue patients with Hodgkin's lymphoma was four or five previous treatments are more prone to virus infections. So we may still see some patients who acquire intermittent.
Speaker Change #139: Comorbidities or intermittent diseases, while in the screening period.
Unknown Executive: Perfect. That's very helpful.
Andreas Harstrick: Perfect. That's very helpful. Thank you.
Unknown Executive: Thank you.
Perfect. That's very helpful. Thank you.
Maurice Raycroft: Our next question comes from Maury Ray-Croft with Jeffries. Your line is open. Hi.
Maurice Thomas Raycroft: Our next question comes from Maurice Raycroft with Jeffreys. Your line is open.
Speaker Change #139: Thank you.
Our next question comes from Maury Raycroft with Jefferies. Your line is open.
Andreas Harstrick: Hi, congrats on the progress and thanks for taking my question. Just based on your insights into enrollment and guidance for having another data update on the first two cohorts and third quarter, at this point, can you project when you think you'll complete the run-in phase and start the randomization phase? I guess, is there anything more on timelines that you're able to say about the study at this point? And then, can you remind me if you need to go back to FDA to get feedback before you can start the randomized part of the study?
Andreas Harstrick: Congrats on the progress and things for taking my question. Just based on your insights into enrollment and guidance for having another data update on the first two courts and third quarter. At this point, can you project when you think you'll complete the run-in phase and start the randomization phase? I guess there's anything more on timelines that you're able to say about the study at this point. And then can you remind me if you need to go back to the FDA to get feedback before you can start the randomized part of the study? Yeah, so let's take the first last question first.
Speaker Change #140: Hi, Congrats on the progress and thanks for taking my question.
Maurice Thomas Raycroft: Just based on your insights into enrollment and our guidance for having another data update on the first two cohorts in third quarter. At this point can you project. When you think you'll complete the run in phase and start the randomization phase I guess is there anything more on timelines that you're able to say about the study at this point and then can you remind me if you need.
Speaker Change #142: To go back to FDA to get feedback before you can start the randomized part of the study.
Andreas Harstrick: Yeah, so let's take the first or last question first so we do not need to go back to FDA. FDA has approved the whole sequence of the study, so it's completely up to our decision to progress into stage one, stage two, and also at which point to open the cohort for peripheral T-cell lymphoma. In terms of guidance, again, we have fully enrolled cohorts one and two, and as I said, we expect to have data on the initial five patients in terms of responses in Q3, and then we will give updates at our earnings calls.
Speaker Change #143: Yeah. So let's take the first the last question first so we do not need to go back to FDA.
Andreas Harstrick: So we do not need to go back to FDA, or FDA has approved the whole sequence of the study. So it's completely in our decision up to our decision to progress into stage one, stage two. Also, at which point to open the cohort for parapheratic cell lymphoma.
Speaker Change #144: And FDA has approved see whole sequence of studies, so it's completely in our decision.
Speaker Change #144: Our decision to progress into the stage one stage two also at which point to open Z.
Andreas Harstrick: Laws. In terms of guidance, again we have fully enrolled in our course one and two, and as I said, we expect to have the data of the additional five patients in terms of responses in Q3, and then we will give updates according to our earnings calls. We also intend to submit these data to the scientific conference. For Q4, 3 and 4, we will do a projection once we ask who is the staggered period. Again, Q4, 3 and 4 half, the first three patients per Q4 staggered. This has been a little bit of uncertainty in Q4, 1 and 2, so I think we don't have better guidance once we have completed the first six patients in Q4, so 3 and 4.
Speaker Change #144: Cohort four peripheral T cell lymphomas.
Speaker Change #145: In terms of guidance again, we have fully enrolled cohorts one and two.
Speaker Change #146: And as I said, we expect to have the.
Speaker Change #147: The data of the additional five.
Speaker Change #147: Patients in terms of responses in Q3, and then we will give updates accordingly.
Andreas Harstrick: We also intend to submit these data to a scientific conference. For cohorts 3 and 4, we will do the projection once we are through the staggered period. Again, cohorts 3 and 4 have the first three patients per cohort staggered. This has been a little bit of an uncertainty in cohorts 1 and 2, so I think we'll have better guidance once we have completed the first six.
Speaker Change #147: Our earnings calls we also intend to submit these data to the scientific conference for.
Speaker Change #147: For cohorts three and four we will do is our projections. Once we are smooth startup period again quarters, three and four have so first three patients per cohort staggered. So this has been a little bit of uncertainty in cohorts, one and two so I think we don't have better guidance. Once we have completed the first six patients in cohorts of Sweden.
Andreas Harstrick: Okay, understood. And I'm just wondering if the data are a mix of cohorts one and two. And at this point, do you have any idea how the two different dose cohorts are comparing as far as the dosing strategy goes?
Speaker Change #147: Sure.
Andreas Harstrick: Okay, understood. And just wondering if you can clarify if the data are a mix of cohorts one and two, and at this point you have any view on how the two different dose cohorts are comparing it as far as the dosing strategies go. Yeah, again it's a limited number of patients. We have equal representation of course one and two. I think we have four patients in one and three patients in two. Up to this point, we did not see any differences; both cohorts have contributed responses and complete responses. Interestingly, we also have not seen any differences in side effects, so the 200 milligrams is 300 milligrams, and some of the mix dose are absolutely similar in terms of the scientific profile.
Speaker Change #148: Okay understood.
Speaker Change #149: I'm just wondering if you can clarify if the.
Speaker Change #150: If the data are a mix of cohorts, one and two and at this point do you have any any view on how the two different dose cohorts are or comparing as far as the dosing strategies.
Andreas Harstrick: Yeah, again, it's a limited number of patients; we have an equal representation of cohorts one and two; I think we have four patients in one and three patients in two. Up to this point, we did not see any differences. Both cohorts have contributed responses and complete responses. Interestingly, we also have not seen any differences in side effects. So the 200 milligram to 300 milligram symptomatic doses are absolutely similar in terms of the side effect profile. Okay.
Speaker Change #150: Yes.
Speaker Change #151: Limited number of patients we have equal.
Speaker Change #152: <unk> representation of cohorts, one and two I think we have for patients and one in three patients into.
Speaker Change #153: Up to this point, we did not see any differences both cohorts have contributed.
Speaker Change #153: Responses and complete responses.
Speaker Change #153: Interestingly, we also have not seen any differences in side effects. So the 200 milligrams or 300 milligram symptomatic dose are absolutely similar in terms of the side effect profile.
Andreas Harstrick: Okay. Okay. Thanks for taking my questions. I'll hop back in the queue.
Unknown Executive: Okay, okay, thanks for taking my questions off. I can thank you.
Speaker Change #154: Okay. Okay. Thanks for taking my questions Opex in the queue.
Lee Watson: Thank you. Our next question comes from Lee Watson with Cancer Fitzgerald. Your line is open.
Li Wang Watsek: Our next question comes from Li Watsek, with Cancer Fitzgerald. Your line is open.
Speaker Change #155: Thank you.
Speaker Change #156: Our next question comes from Lee what sick with Cantor Fitzgerald. Your line is open.
Andreas Harstrick: Hey, good morning. Thanks for taking my questions. I wonder if you can just comment on, you know, the number of cycles that these seven patients are being treated with. And I know the protocol allows up to three cycles. So, just wonder if you can give some information there.
Andreas Harstrick: Hey, good morning. I think for taking my questions. I wanted to just comment on, you know, the number of side cohorts at these revocations being created, and I know the protocol allows up to three cycles, so just wondering if it can give them the information there. Yeah, currently we basically have, for everything, so we have a couple of patients in the second cycle; we have patients who are going into side to three. We have a patient who is now going to side transplant in complete response, so it's, yeah, it's a mixture of cycles. Importantly, as the treatment has been very, very colorated, so we have not seen any treatment discontinuations due to side effects, and all patients basically go as plans with their sequence of cycles.
Speaker Change #157: Hey, good morning.
Speaker Change #158: Taking my questions.
Speaker Change #159: I Wonder if you can just comment on the number of cycles that the sanitation readout.
Speaker Change #160: So the protocol allows.
Speaker Change #160: Recycling. So just wondering if you can give any information there.
Andreas Harstrick: Yeah, currently, we basically have everything, so we have a couple of patients in the second cycle. We have patients who are now going into cycle three. We have a patient who is now going to a stem cell transplant with an incomplete response. So it's a mixture of cycles. Importantly, the treatment has been very well-tolerated, so we have not seen any treatment discontinuations due to side effects. And all patients basically go as planned through their sequencing.
Speaker Change #161: Yes currently we.
Speaker Change #161: Basically half of everything so we.
Speaker Change #162: Have a couple of patients in the second cycle, we have patients who are now going into <unk>.
Speaker Change #162: We have a patient who is now going to stem cell transplant in complete response.
Speaker Change #162: So it's yes it's.
Speaker Change #162: It's a mixture of cycles.
Speaker Change #163: Importantly, as the treatment has been very well tolerated. So we have not seen any treatment discontinuation due to side effects and all patients basically go as plants was out of sequence of cycles.
Andreas Harstrick: Okay, and then maybe a follow-up question for the patient baseline characteristics enrolled in the study versus the MD Anderson 104 study. Can you maybe just, you know, comment on prior lines of treatment and, you know, any response to the most recent treatment for these patients? And I remember, I think, in the 104 study, we're looking at maybe seven prior lines of treatment versus here four. Maybe just talk a little bit about how we should think about, you know, patients enrolled.
Andreas Harstrick: Okay, and then maybe a follow-up question for the patient baseline characteristics in broad in the study versus the MD Anderson 104 study. Can you maybe just, you know, comment on the fire lines of treatment and, you know, any response to most recent treatment of 40 patients? And I remember, I think, in the 104 study, we're looking at maybe seven pyrelines of treatment versus here four. Maybe just talk a little bit about how should we think about, you know, patient, patient thing for. Sound. Yeah, so here we have technically somewhat sort a number of or lower number of the previous treatment lines, which I think is already reflecting what we expect to see also in the marketplace.
Speaker Change #163: Okay, and then maybe a follow up question.
Speaker Change #164: For the patient baseline characteristics in ground in the study.
Speaker Change #165: The MD Anderson one of four study can you maybe just comment on prior lines and treatments.
Speaker Change #165: <unk>.
Speaker Change #166: The response, Q lunchmeat and no treatment for these patients and I remember I think in one of four study.
Speaker Change #166: We're looking at maybe seven prior lines of treatment versus here for maybe.
Speaker Change #167: Maybe just talk a little bit about how should we think about patient pay.
Tim Rolland: Tim Rolland.
Andreas Harstrick: Yeah, so here we have technically a somewhat shorter number of or lower number of previous treatment lines, which I think is already reflecting what we expect to see in the market. I mean, patients before we published the MD Anderson data, they simply did not have any. Any alternatives? So physicians were trying quite exotic things, which amounted to this high number of previous lines of therapy. Now, with this very active treatment available, physicians are starting to refer earlier patients to this treatment option because they also feel that this is by far the best chance for patients who have failed chemotherapy, etc. at PD-1.
Tim Rolland: Yeah.
Speaker Change #169: So here are we.
Speaker Change #170: Pass Tech.
Speaker Change #171: Nicley somewhat sort of number or lower number also of previous treatment lines.
Speaker Change #171: Which I think is already reflecting what we expect to see also in the marketplace.
Andreas Harstrick: When patients are before we publish the MD Anderson data, they simply did not have any alternatives, so physicians were trying quite exotic things, which amounted to this high number of previous lines of therapy. Now, with this very active treatment available, physicians taught to refer earlier patients to this treatment option because they also feel that this is far the best chance of patients with faith chemotherapy, et cetera, at PD1. So it's a good development, I think, because patients get to potentially life-saving treatment earlier. It is good also in terms of market projection if we can establish this regimen in earlier lines of treatment.
Speaker Change #172: I mean patients before we publish the MD Anderson data they simply did not have any.
Any alternatives, so physicians were trying quite exotic things which amounted to this.
Speaker Change #172: Number of previous lines of therapy.
Speaker Change #172: Now with this very active treatment available.
Speaker Change #172: Physicians.
Speaker Change #173: Cloud to refer earlier patients.
Speaker Change #174: Is this a treatment option because they also feels that this is by far has the best chance of patients.
Speaker Change #175: Fifth chemotherapy etcetera and PD one.
Andreas Harstrick: So, it's a good development, I think, because patients get to potentially life-saving treatment earlier. It is also good in terms of market projections if we can establish this regimen in earlier lines of treatment. Importantly, the FDA was very clear on what defines a patient with unmet medical need, and that is failure of combination chemotherapy, failure to PD-1, and failure to, etc., and all these patients fulfill the FDA-required criteria for unmet medical need. Okay, great. Thank you.
Speaker Change #175: So it's a good development I think because patients get to potentially.
Speaker Change #176: Potentially life saving treatment earlier. It is good also in terms of market projection. If we can establish this regimen in earlier lines of treatment in.
Andreas Harstrick: Importantly, the FDA was very clear on what defines a patient with unmet medical need, and that is failure of combination chemotherapy, failure to PD1, and failure to, et cetera, in all these patients, fulfills the FDA required criteria for unmet medical need.
Speaker Change #176: Importantly, the FDA was very clear on what defines a patient with unmet medical need and that is a failure of combination chemotherapy, Australia to PD, one and say get to et cetera, and all these patients fulfills the FDA required criteria for unmet.
Speaker Change #176: Medical need.
Unknown Executive: Okay, great, thank you.
Speaker Change #177: Okay, great. Thank you.
Yale Jen: Thank you, and our next question comes from Yale, Jen, with Leila on company; your line is open. Good morning, and thanks for taking the questions and the Congress on the progress. Just two quick ones here.
Yale Jen: And our next question comes from Yale Jen with Lelaw and Company. Your line is open.
Speaker Change #177: Thank you.
Speaker Change #178: And our next question.
Speaker Change #179: It comes from Yale Jen with Laidlaw <unk> Company. Your line is open.
Andreas Harstrick: Good morning and thanks for taking the questions and congratulations on the progress. Just two quick ones here. The first one is for AFN 28. You guys are talking about seeking, adding a case cell to the study. What's the current progress, and what was the option being considered at this moment?
Yale Jen: Good morning, and thanks for taking the questions and congrats on the progress.
Andreas Harstrick: The first one is for AFN-28. You guys are talking about seeking, I think. Okay, sell to the study. What's the current progress and what was the option being considered at this moment? Yeah, we are in an active process to identify an eligible criteria, preserved in case of products. These are consultations; these are ongoing, so I cannot share a lot of details here, but I think we are on a very good way.
Speaker Change #182: Two quick ones here. The first one is for 2008.
Speaker Change #181: Talking about seeking.
Speaker Change #181: Hey.
Speaker Change #181: Okay.
Speaker Change #181: Study.
Speaker Change #181: What the current progress.
Speaker Change #181: The options being considered at this moment.
Andreas Harstrick: Yeah, we are in an active process to identify an allogeneic cryopreserved NK cell product. These are discussions, these are ongoing, so I cannot give you a lot of details here, but I think we are on a very good track.
Speaker Change #183: Yes, we are in active.
Speaker Change #184: In an active process to identify.
Speaker Change #185: <unk> Cryopreserved NK cell products. These are discussions that are ongoing so I cannot share.
There are a lot of details here, but I think we are on a very good way.
Yale Jen: Okay, great. Maybe just one housekeeping question.
Michael Wolfe: Okay, great. Maybe one of the housekeeping questions. We just noticed that for the last quarter, there's a 23 million cash use that you guided at the guidance in terms of runway two, the second half of next year. From modern purpose, should we consider the expense going forward for the next few quarters will be reviewed small and that will be the projection. Would that be the projection? Thanks.
Speaker Change #186: Okay, great and maybe one.
Speaker Change #187: And questions, we just noticed that for the last quarter.
Yale Jen: We just noticed that for the last quarter, there was a $23 million cash use, and you guided the guidance in terms of rumbling to the second half of next year. Should we, for modeling purposes, should we consider the expense going forward for the next few quarters will be reduced more? And that will be the projection. Will that be the projection? And thanks.
Speaker Change #188: 23 million of cash use.
Speaker Change #188: In your guidance.
Speaker Change #189: In terms of that run rate to the second half of next year should we.
Speaker Change #190: For modeling purpose should we consider the expand going forward for the next few quarters will be.
Speaker Change #191: Radio is more.
Speaker Change #192: That will be.
Speaker Change #193: Would that be the projection.
Speaker Change #193: Sure.
Michael Wolfe: Now, I think that's the question I would end over to Harry or Michael. No, I'm happy to answer this question. So, the cash guidance in due age to 2025 is based operational financial plans. So, one element contributing to that. This is a significant deal over spend. As a matter of fact, we spend in Q1 2020-2010 million more than in Q1 this year, so we do have reduced spend based on the fact that we only have as the personnel. We significantly reduce costs regarding lease, expense, etc., so that's one contribution. The other one includes certain amounts or payments to be made, be it with business development, or be it with other financing transactions, and we continue to tightly monitor our spending, and so that's how this guidance came along.
Michael Wolf: I think that's a question I would hand over to Harry or Michael.
Speaker Change #193: Yeah.
Speaker Change #194: I think that's a question I would hand over to Harry or Michael.
Michael Wolf: No, I'm happy to answer this question. So the cash guidance into H2 2025 is based on operational financial plans. So one element contributing to that is a significantly lower spend. As a matter of fact, we spend 10 million more in Q1 2023 than in Q1 this year. So we do have reduced spend based on the fact that we only have half the personnel. We significantly reduced costs regarding lease expense, etc. So that's one contribution.
Speaker Change #195: No I'm happy to answer this question. So the cash guidance in two age to 2025 is based on operational financial plans. So one element contributing to that is a significantly lower spend as well.
Speaker Change #196: The effect, we spend in Q1, 2023 10 million more than in Q1. This year. So we do have reduced spend based on the fact that we only have half the personnel, we significantly reduce costs regarding lease expense et cetera. So that's one contribution.
Michael Wolf: The other one, it includes certain amounts or payments to be made, be it for business development or be it for other financing transactions. And we continue to tightly monitor our spending. And so that's how this guidance came about.
Speaker Change #196: It includes certain amounts or.
Speaker Change #197: Payments to be made with business development or beat with quarter financing transactions and we continue to tightly monitor our spending and so that's how this guidance came along.
Yale Jen: Okay, great. That's very helpful, and thanks for taking the time.
Unknown Executive: Okay, great. That's very helpful.
Unknown Executive: I think we'll take any questions. Welcome.
Okay, Great. That's very helpful. Thanks for taking the question.
Speaker Change #198: Youre welcome.
Bradley Patrick Canino: Thank you. And our next question comes from Brad Canino with Stiefel. Your line is open.
Brad Canino: Thank you. And our next question comes from Brad Canino with Steephil; your line is open. Thank you.
Speaker Change #198: Thank you and our next question comes from Brad Canino with Stifel. Your line is open.
Bradley Patrick Canino: Just to double-click on the dropouts question following Daina's question, I think the question, when there are so many dropouts, is always the potential for the results to have some form of bias from a selection of a narrow patient population and maybe those that are fit enough to wait as the enrollment process is being streamlined. It would be good to hear your view on whether or not this has occurred. And second, could you talk about your ongoing relationship with Arteva and both companies' commitment to the study as the program continues to advance now? Thank you.
Brad Canino: Just a double click on the dropouts question following, Dana's question. I think the question, when there are so many dropouts, is always the potential for the results to have some form of bias from a selection of a narrow patient population. Maybe those that are fit enough to wait as the enrollment process is being streamlined. It would be good to hear your view on whether or not this has occurred.
Bradley Patrick Canino: Thank you.
Speaker Change #200: Double click on the Dropouts question following Dana's question.
Bradley Patrick Canino: I think the question when there are so many dropout is always the potential for the results to have some form of bias from a selection of a narrow patient population and maybe those that are fit enough to wait as the enrollment process is being streamlined it would be good to hear your view on whether or not this has occurred in <unk>.
Andreas Harstrick: And second, could you talk about your ongoing relationship with our Tiva and both companies' commitments to the study of the program continues to advance now? Thank you. Yeah, so for the dropouts, as I said, we have not seen any pattern, and importantly, I do not see any indication of the selection bias. Again, it's a very mixed, mixed bag of reasons. Some are logistic. My belief is that that will be solved if we have even a broad geographic spread of participating sites. Some is that people were, I think, very enthusiastic, and we see this enthusiasm on our investigators' side to enroll a patient, and some patients did not really fulfill all criteria for unmet medical need.
Speaker Change #201: Could you talk about your ongoing relationship with our Tivo and both companies' commitments to the study of the program continues to advance now thank you.
Andreas Harstrick: Yeah, so for the dropout, as I said, we have not seen any pattern. And importantly, I do not see any indication of a selection bias. Again, it's a very mixed bag of reasons. Some are logistic, and my belief is that that will be solved if we have even a broad geographic spread of participating sites. Some is that, yeah.
Speaker Change #202: Yeah. So for the dropouts as I said, we have not seen any pattern in <unk>.
Speaker Change #202: Importantly.
Speaker Change #202: I do not see any indication of a selection bias.
Speaker Change #202: Again, it's a very mixed.
Speaker Change #203: Mixed bag of reasons.
Speaker Change #203: Some are logistic my belief is that that will be sold.
Speaker Change #203: We have even a broad geographic spread of participating sites.
Speaker Change #204: Some is set.
Andreas Harstrick: People were, I think, very enthusiastic, and we see this enthusiasm on our investigators' side to enroll a patient, and some patients did not really fulfill all criteria for unmet medical need. As I said, we had patients who had not been pre-treated with etceteras. These patients are receiving CETRAS treatment now, and they will have the option, if they should fail CETRAS, to go back into the study. We have a very clear, defined population of patients, again, failing chemotherapy, failing PD-1, failing, etc., and if they are transplant eligible, they should also have received a transplant before.
Speaker Change #204: People were I think very enthusiastic and we see this enthusiasm on our investigator sites to enroll patients and some patients did not really fulfill all criteria for unmet medical need as I said, we had patients who had not been pretreated with ADCETRIS <unk>.
Andreas Harstrick: As I said, we had patients who had not been treated with et cetera. These patients are receiving a set of treatment now. They will have the option, if they should fail, et cetera, to go back into the study. We have a very clear, defined population of patients. Again, failing chemotherapy, failing PD1, failing et cetera. And if they are transplant eligible, they should also have received a transplant before, and so this is something that FDA agreed upon is an area of complete unmet medical need. And we will stick very closely to this FDA guidance, but I do not see any selection bias or any enrichment of certain patients.
Speaker Change #205: These patients are receiving etc treatment now they will have the option if they should fail et cetera to go back into the study we have a very clear defined.
Speaker Change #205: Population of patients again, failing chemotherapy, failing PD, one trailing etc, and if they are transplant eligible I should also have received a transplant beforehand.
Andreas Harstrick: Also, this is something that FDA agreed upon is an area of complete unmet medical need, and we will stick very closely to this FDA guidance, but I do not see any selection bias or any enrichment of certain. In terms of our relationship with Arteva, they are as enthusiastic about the data as we are. We have a good relationship. We have strong support from the Arteva side to continue this study and this program. So there's nothing else to report other than a real working relationship.
Speaker Change #206: So this is something that FDA agreed upon is the area of complete unmet medical need and we will stick very closely to this FDA guidance, but I do not see any selection bias or any enrichment of certain patients.
Andreas Harstrick: In terms of our relationship with Artiva, they are as enthusiastic about the data as we are. We have a good relationship; we have strong support from the Artiva side to continue on this study and on this program. And so there's nothing else to report other than a real working relation. Thank you.
Speaker Change #207: In terms of our relationship with our team.
Speaker Change #207: They are as enthusiastic about the data as we are.
Speaker Change #208: We have a good relationship we have strong support from the <unk> side to continue on this study on this program and so there is nothing else to report other than really working relationship.
Bradley Patrick Canino: Great to hear the color. Thanks, Andres. Thank you.
Speaker Change #208: Great to hear the color. Thanks Andreas.
Operator: Thank you. As a reminder, if you'd like to ask a question, please press Star 1 1. There are no further questions. This does conclude the Q&A session. You may now disconnect. Everyone have a great day.
Unknown Executive: As a reminder, if you'd like to ask a question, please press Door 1-1. There are no further questions. This does include the Q&A session.
Andrew: Thank you Andrew.
Andrew: Amanda if you'd like to ask a question. Please press star one one.
Speaker Change #210: There are no further questions. This does conclude the Q&A session. You may now disconnect everyone have a great day.
Unknown Executive: You may now disconnect. Everyone, have a great day. Thank you. Bye bye.
Andreas Harstrick: Thank you. Bye-bye.
Unknown Executive: Welcome.
Speaker Change #211: Thank you bye bye.
Okay.
Speaker Change #211: [music].
Speaker Change #211: Okay.
Speaker Change #211: [music].
Speaker Change #211: Yeah.
Speaker Change #211:
Speaker Change #211: Yeah.
Speaker Change #211: [music].