This conference call transcript was computer generated and almost certianly contains errors. This transcript is provided for information purposes only.EarningsCall, LLC makes no representation about the accuracy of the aforementioned transcript, and you are cautioned not to place undue reliance on the information provided by the transcript.
spk01: Good afternoon and welcome to the YMABS Therapeutics Incorporated Earnings Conference Call for the third quarter of 2022. At this time, all participants are in a listen-only mode. Later, we will conduct a question-answer session and instructions will follow at that time. As a reminder, today's conference will be recorded. Let me quickly remind you that the following discussion contains certain statements that are considered forward-looking statements. as defined in the Private Securities Litigation Reform Act of 1995. Such statements include, but are not limited to, statements about our business model and development, commercialization, and product distribution plans, current and future clinical and preclinical studies, and our research and development programs, expectations related to the timing of the initiation and completion of the regulatory submissions, regulatory marketing and rehabilitation reimbursement approvals, including statements with respect to the potential FDA approval and utility of Umberto Mob pipeline development programs, potential for Danielsa territory expansion and advancement of SADA, collaborations or strategic partnerships and the potential benefits thereof, expectations related to our anticipated cash runway, and the sufficiency of our cash resources. Daniela's revenue guidance and other guidance for 2022 and future years, and our financial performance, including our estimates regarding revenues, expenses, and capital expenditure requirements, and other statements that are not historical facts. Because forward-looking statements involve risk and uncertainties, they are not guarantees of future performance, and actual results may differ materially from those expressed or implied by these forward-looking statements due to a variety of factors, including those risk factors discussed in the company's quarterly report on Form 10-Q for the third fiscal quarter ending September 30, 2022, as filed with the SEC on November 7, 2022. At this time, I would like to turn the conference over to Thomas Gad, the company's founder, interim CEO, and president. Please go ahead.
spk09: Thank you, Danielle. Good afternoon, everybody, and thank you for joining us today. With me today, I have Bo Cruz, our Chief Financial Officer, and our Chief Commercial Officer, Sue Smith, and our Chief Medical Officer, Vignesh Ryan. Let me begin by briefly reviewing with you the highlights of our third quarter. First and foremost, Danielle's sales picked up notably, and we are proud to report record revenue in Q3 of $12.5 million, up 28% compared to Q2. and up 20% compared to Q1 of this year, which had previously been our best quarter to date. However, on October 28th, the ODAC Adcom Panel regrettably voted 16 against and zero in favor of the assessment of the overall survival of Ombrizumab for the treatment of CNS metastases from Northostoma. We anticipate a decision from the FDA by and before the previously reported to-do for date of November 30th, 2022. As a reminder, the FDA is not bound by the advisory committee's recommendations, but generally takes the recommendations into consideration when making its decision. In light of this development, I would like to assure you that the company had already developed scenario planning to ensure we were ready for any potential outcome, including this unfortunate one. We will provide a more detailed strategic and operational update following the FDA's formal decision and feedback. I believe it's important to reiterate that our current cash run rate is based on our existing cost structure, currently extending into mid-2024, without any PFE proceeds from number to map, which Bo will talk about later on the call. Turning to Danielsa. All of us at YMAS are truly proud of our launch today and being able to offer to children Danielsa following accelerated approval for the treatment of relapse and refractory high-risk neuroblastoma. in the bone and bone marrow who have demonstrated a partial response, minor response, or stable disease to prior therapies. We are making considerable efforts to expand access to Danielsa outside of the U.S. Danielsa was recently approved in Israel for relapse of refractory hyaluronidinoma, and will be commercialized by our partner, Takeda. Regulatory submission was also completed by ADIOM in Brazil in September 2022, on the tail of submissions in Mexico and Colombia. We look forward to continuing Danielsa's expansion efforts in the Latin region. We also hope to see a decision on regulatory approval in China on our collaboration with Cyclone any day now. As I mentioned, our Danielsa revenues have increased 28% from our previous quarter, primarily driven by an increase in new U.S. patients as our Chief Commercial Officer Sue Smith has been leveraging her prior experience in leading global product launches and delivering operational efficiencies with other companies to highlight and differentiate Danielsa in the U.S. and potentially other markets. We are starting to see the positive impact of our strategic development plan and its execution and are confident that we remain on the right track and are pleased to reaffirm our full year 2022 Danielsa revenue guidance of 45 to 50 million. And with that, I'm pleased to have Sue go on with our call today. Over to you, Sue. Thank you.
spk05: Thank you, Thomas, and good afternoon, everyone. I'm pleased to be with you all today, and I'm happy to have the opportunity to talk about the progress we've made. We believe that Q3 proved to demonstrate our strategic commercialization plan supports our strong third quarter revenue growth. The patient is at the center of everything we do and fuels our team every day. Our growth drivers stem from three key areas. First, caregiver engagement. Second, new patient identification. And three, an aligned field and marketing team focused on key customers. First, our caregiver education and support programs, which I discussed on our last call, are a meaningful way to provide education and support. We continue to provide new resources and support here that lead to meaningful parent-physician dialogue and initiation of treatment. Second, in an orphan indication, when you are following such a small number of patients, patient identification is essential. This has also been a focus of the team, filling the funnel with qualified leads and managing those relationships over time until that patient becomes relapsed or refractory and is converted to Danielza. And third, the marketing and sales team have very aligned plans and a marketing mix focused on the target and opportunity accounts. This consistent focus with the right message at the right time and also formulary inclusion in 43 accounts slowly has been building to what we believe is an appropriate patient conversion. As a result, Danielza adoption is trending slightly upward in the anti-GD2 market, exiting the third quarter of 2022. We gained seven new customers in Q3, including several notable centers of excellence. By the end of the quarter, we had 43 accounts, with 18 of those or 40% who have had two or more patients on Danielza. The team celebrated in August when we hit several new highs in terms of sales and enrollments with the highest number of patients ever in the hub and the highest number of vials sold in one day of 99. I'm proud of the team and we are excited to continue building on the solid foundation we have in place for Danielza. Thanks for your time and back to you, Thomas.
spk09: Thank you, Sue. Building on this renewed momentum in the pediatric arena, it is important to remember that YMAPS is also committed to potentially introducing tanyelza into larger adult indications and continue to explore potential partnerships to address this opportunity. We believe that YMAPS is well-positioned to unlock the further potential of our platform to provide benefits to more patients while creating value for our shareholders. In the clinic, We have initiated a new investigator-sponsored study. We've named it BCC018 with B Childhood Cancer Research Consortium during the third quarter. This is a multi-center phase two trial of Nexidimat in combination with standard induction therapy for patients with newly diagnosed high-risk neuroblastoma. We anticipate that the addition of NGDD2 therapy to induction chemotherapy should result in the improved end of induction responses and improved survival. We plan to have a total of 40 to 50 sites in the U.S. and Canada. The study is already recruiting and dosing patients, and the target enrollment is 76 patients. Further, we continue to work on our planned pivotal multicenter osteosarcoma trial for Danielsa, which we plan to open in 2023. As you can hear, we are very excited about the various possibilities going forward to expand the commercial opportunity of Tanyalta while addressing additional pediatric unmet medical needs. Turning now to SARTA technology or liquid radiation. SARTA is a key innovative platform in our portfolio that we believe continues to show great promise in the targeted delivery of radiopharmaceuticals to tumor sites with minimal off-target effects providing opportunities to significantly increase their therapeutic indexes. As we continually optimize the technology, we become even more encouraged about the potential scientific advancement it represents for the company and the medical community. During the third quarter, we received the IND clearance for our first solid construct, GD2 solder for GD2 positive solid tumors, and we expect the first clinical site to open in this quarter. with the initial efforts to validate DD2-SATA by treating adults in small cell lung cancer, sarcoma, and melanoma. We believe that we are well-positioned to explore potential partnership options to leverage our proprietary SATA platform. Our SATA platform is highly differentiated due to our two-step infusion, collecting pharmacokinetic data by imaging, thus enabling us to de-risk programs early on. and due to the fact that our technology makes it possible for our potential partners to use large infusion centers in large indications as our drug is infused as a protein-only injection first, followed by an isotope injection, our unique two-step method, making it possible to involve the med-on and avoiding having to send patients straight to nuclear medicine departments. We expect to treat the first patient in this trial late in the fourth quarter of this year and anticipate sharing data in 2023. We also plan to explore repurposing of previously failed late-stage clinical constructs that have already been proven in humans by optimizing them into a SADA construct. Moving on to our bispecific programs, the IND for our CD33 bispecific for pediatric AML has been clear. We believe this product candidate could potentially address one of the most challenging for children as AML remains an important pediatric unmet medical need. We have treated the first patients, two in fact, in this phase one trial and are looking forward to reporting data as the study unfolds. We continue to work efficiently to support Danielsa with a global commercial footprint through regional partnerships across the globe. As you know, we established a partnership with Cyclone Pharmaceuticals for Danielsa expansion in Greater China. We are especially excited about the prospect for a regulatory determination on the potential approval in China that is expected to take place any day now and would trigger a $50 million regulatory milestone to the company. We believe this market could potentially be an important revenue driver for Danielsa's Asian sales. We have also witnessed the This quarter is encouraging progress among our partners covering Latin and Eastern Europe and Israel to support the potential and continuing to work on widening our outreach, subject to regulatory approval in the relevant areas. We ended the third quarter of 2022 with $114.5 million in cash, with a strong runway and a robust pipeline, and we believe we are well-precision to continue our efforts to deliver further clinical and commercial milestones support the continued commercialization of Danielsa, and advance our early stage program, including the revolutionary starter technology constructs. We are comfortable with our current financial position, which Bo Kruse will now elaborate on in his financial update.
spk13: Thank you, Bo. Thank you, Thomas, and good afternoon, everybody.
spk07: Our net revenues of $12.5 million and 33.8 million for the third quarter 2022 and nine months into September 30th, 2022 represented increases of 40 and 34% respectively, over 9 million and 25.3 million in the comparable periods of 21. Net revenues in the nine months into September 30th, 2022 included $1 million of license revenue compared to $2 million worth of license revenue in the corresponding period in 2021. Then we also have product revenues for the quarter and nine months ended September 30, 2022, where $12.5 million and $32.8 million respectively, which represented increases of 40% and 41% respectively over the corresponding period in 2021. Danielsa product revenues of $12.5 million for the third quarter 2022 increased by 28% compared to the second quarter of 2022, where we reported Danielsa product revenues of $9.8 million. The increase was primarily driven by an increase in new U.S. patients in the third quarter of 2022. Moving to operating expenses, our R&D expenses decreased by 0.7 million to 22.4 million for the quarter ended September 30, 2022. The decrease reflects decreased spending for clinical trials, partially offset by increased costs for outsourced manufacturing. R&D expenses increased by $7.3 million to $71.8 million during the nine months into September 30, 2022, compared to the prior year period. This increase reflects an increase in outsourced manufacturing and increased personnel costs dedicated to our advancement of the Nielsa, Convertimap, and Lassata constructs. SG&A expenses decreased by $0.4 million to $13.6 million for the three months into September 30, 2022, compared to $14 million for the three months into September 30, 2021. The decrease in SG&A expenses was primarily the result of a $1.5 million increase in salary and stock-based compensation expenses, partially offset by increased costs related to the commercialization of Danilsa. Our SG&A expenses increased by $10.7 million to $50.1 million for the nine months ended September 30, 2022. The increase in SG&A expenses was primarily attributable to an $8.9 million increase in severance and share-based compensation expense related to our former chief executive officer in the nine months ended September 30, 2022, as compared to the comparable period in 2021, and to a lesser extent, the commercialization of the Nielsen. We reported a net loss for the quarter into September 30th, 2022 of 27.5 million or 63 cents per share, basic and diluted, compared to a net loss of 28.9 million or 66 cents per share, basic and dilute, for the quarter into September 30th, 2021. The decrease in net loss was primarily driven by the gross profit impact of increased revenues. Additionally, we reported a net loss for the nine months in the September 30th, 2022 of 96.7 million or $2.21 per share basic and diluted compared to a net loss of 18.4 million or 43 cents per share basic and diluted for the nine months in the September 30th, 2021. Net loss in the nine months in the September 30th, 2021 included a $62 million net gain from the sale of our Danielsa Priority Review voucher after sharing 40% of the net proceeds from the sale with MSK as per the license agreement. The decrease in earnings in the nine months into September 30, 2022 also reflects the one-time impact of contractual severance-related benefits for our former chief executive officer and increased R&D expenses, both as noted above, partially offset by the favorable impact of Danielsa's growing revenues. As Thomas mentioned, we ended the third quarter of 2022 with a cash position of $114.5 million compared to $181.6 million at year-end 2021. The decrease of $67.1 million year-to-date and the decrease of 19.2 million compared to the second quarter cash balance reflects that our cash burn slowed by about 20% during the third quarter of 2022 as compared to the year-to-date average in the first half of the year. Our cash burn essentially dropped from $24.9 million in the first quarter to $23.1 million in the second quarter and now $19.2 million in the third quarter. Consistent with prior quarters, we believe that our current cash position is sufficient to fund our current operations into mid-2024 and provides a solid financial runway to support our commercial activities and our highlighted pipeline programs. As we noted in the prior quarter, the underlying assumptions for this guidance are important to understand, and we did not include any assumption for the net proceeds that would be received on a potential receipt and sale of a PAV form burden map if approved. In addition, no new partnerships or other new BD-related sources of income are included in the assumptions. Any potential on burden map revenues upon approval are also excluded. The Daniosa product revenues are assumed to increase by 10% each year for the purpose of this analysis of runway, and we assume a regulatory license fee for the Daniosa approval in China. We hope to see a higher growth rate for Daniosa in the years to come as we execute our refined commercial strategy and continue to deliver clinical data that could potentially lead to expanded indications and greater physician adoption. In terms of development activities, We have assumed that current programs will be advanced at our own expense and no new programs are assumed at this point. This financial runway forecast benefits from the fact that most of the expenses related to pivotal trials, post-marketing commitments, and regulatory activities are behind us at this point. For the purpose of the guidance, we have not assumed any equity or debt offerings or borrowings. Also, As previously disclosed, we continue to expect operating expenses of $162 to $167 million and a total cash burn of $78 to $83 million for the full year 2022. We will review our operating expenses based on the final FDA feedback on the Umberta MAP BLA and expect no adverse impact on our cash runway. We believe YMAS remain in a healthy financial position to execute our strategic mission, our priorities, and to support the delivery of multiple milestones. This concludes the financial update, and I'll now turn the call back to Thomas.
spk09: Okay, thank you, Bo. This marks the end of today's prepared remarks. Operator, we can now open up for Q&As. If you want to go through the process of that, please.
spk01: We will now begin the question and answer session. To ask a question, you may press star, then 1 on your telephone keypad. If you're using a speakerphone, please pick up your handset before pressing the keys. To withdraw your question, please press star, then 2. The first question comes from Alec Stronahan of Bank of America. Please go ahead.
spk02: Hey, guys. Thanks for taking our questions. Just a couple from us. First, maybe for... pursue looking at Daniels in the third quarter, obviously encouraging increases over the same time last year, 40%, something like a 20, 25% growth from 2Q. Would you say that most of the demand in 3Q was, you know, organic, just trying to get a sense of, you know, the current and expected near-term demand? And then secondly, on the Bertinab filing in the EU, I think the marketing authorization was filed last year. Is the plan still to seek approval in the EU or will you wait for the FDA's decision before deciding either way? Any other color on the stage in the regulatory process or meaningful differences between your FDA and EMA conversations would be helpful. Thanks.
spk12: Thanks, Alex. In terms of the growth that we saw in third quarter,
spk05: We also were very happy to see that. I think it was organic. I think the business fundamentals are solid and the new programs that we put in place in terms of patient finding and the focus of the team on the priority accounts is taking root. And so we anticipate that to continue in terms of a solid foundation. It wasn't just on a whim. So, you know, we're heartened to see that. In terms of umbertumab, Thomas, would you like to handle that or?
spk09: So, Alec, yeah. Alec, so we had the oral explanation meeting with EMA. And EMA has raised some major objections along the lines of the FDA that we saw the ODAC. So, we're waiting for their opinion to come out. later this month or maybe in December, depending on the schedule of their meeting.
spk13: That's a final opinion. Okay. Makes sense. Thanks for the call. Yep.
spk01: The next question comes from . Please go ahead.
spk06: Great. Thanks for taking the question. Congrats on the Danielle's progress here. Just wanted to get a sense on sort of the you know, frontline indication for Danielza, the progress there, and when we could potentially see incremental data to support that drug's profile in the frontline setting. And then maybe a similar question for osteosarcoma, when we could see some data that supports the progress into pivotals next year. Thank you.
spk09: Yeah, so we have, we are waiting for MSK's trial 16-1643 frontline trials will read out and potentially be submitted. And also we have the osteosarcoma trial. We have a single center trial at MSK where we have recruited, I believe, 46 out of 49 patients. So when that's fully recruited, that will read out too. And then we are planning to file an IND in the first quarter of 2023 for a phase two pivotal multi-center trial, global trial for osteosarcoma.
spk13: Tiny, thank you.
spk01: The next question comes from Bill Mahan of Canaccord Genuity.
spk10: Hey, good afternoon. Thanks for the question. So for UmbertaMed, if somehow the FDA were to decide that giving them that need to allow this on the market, do you think that it would, you'd still have an intact commercial message to support the drug? And if the decision goes the other way, what sort of, you know, scenario planning do you, have you done in terms of potentially further studying the profile of the drug to generate some supportive data?
spk13: Thanks.
spk09: I think we, you know, we've worked with this drug a long time, and we believe in its overall impact on OS, and I think we're very committed to PFK, approve the drug, and give us some PMRs and PMCs. That said, you know, We are right now waiting for the response from the FDA, as we will learn from that response as well, no matter what way it goes. So I think at this point, we're in a wait-and-see mode in terms of what's going to happen going forward with the program in case it would be a negative outcome.
spk10: Okay. And on the Danielza launch, I know there was some good commentary around the patient funnel, but what can you help us quantify maybe the increase in patients in the funnel and the lag time from patients entering the funnel to becoming potential commercial patients and your confidence in the conversion rate between filling the funnel and getting those patients on on drugs just really anything to to read through to potential you know final revenue launch metrics
spk12: Sure.
spk05: Well, I think that right now the team has a funnel that they have been tracking. We have formal systems around. And in terms of the conversion rates, it can take anywhere from 6 to 12 months for a patient to become relapsed or refractory. I don't really want to give away our numbers and percentages just from a competitive standpoint, but in terms of conversion, we are seeing a number of those patients converting over. And the leading indicator for us are the number of enrollments in our hub, which is a mandatory hub. That provides you the reimbursement and support services and we have consistently had the highest number of enrollments in the hub of 18 to 19 per month for the past couple of months So I think that I look to that as a leading indicator Those are patients who are going through to make sure that you know, they have insurance coverage, etc so they're they're highly qualified they're queuing up to own the product and and I think to me that is the most robust leading indicator. And we continue to get the new leads in, you know, every month from a variety of sources that the team then follows. So at this point, I think that plus the core base of 43 key customers and continuing to gain formulary experience and now repeat experience, Our depth of experience is growing outside of slum cuttering, and 40% of our prescribers have treated two or more patients. So I think the levers of growth come not only from the patient funnel, but getting more confidence and experience with the product and, you know, even re-challenging some of our patients with another course of Danielza, now almost two years post-launch.
spk13: All right. Thank you very much. Mm-hmm.
spk01: The next question comes from Tessa Romero of JP Morgan. Please go ahead.
spk00: Hey, guys. Thanks so much for taking our question. So the first one on Donyelza, how did the vials sold compare sequentially from 3Q to 2Q in the US? And are you able to disclose what the gross to net was in 3Q? Just curious, any thoughts on why the vials sold from MSK are outpacing that ex-MSK despite your expansion or growing of your centers here?
spk12: Thomas, I'm assuming you want me to take that.
spk05: So I'm not sure if I understand your question from 3Q to Q2 on the vials sold. But we had almost a 30% increase.
spk00: And I think the... Sue, sorry. So you're basically talking about a 28% quarter-over-quarter revenue increase. But what I'm trying to understand is if there was any fluctuation in gross to net there, right? That could have impacted kind of your viable sold change.
spk12: Not tremendously.
spk09: No. The gross net, I mean, Beau, you can comment. I mean, the gross net was similar to Q2, right?
spk07: It's in the same level as it has been for prior quarters, with the exception of a minor adjustment of some Medicaid accruals. But the naked gross net is within a couple of percent of what we saw in the prior quarter. It's actually improved a little bit, but it's essentially the same.
spk00: Okay, that's helpful. And then as a follow-up here, I know we're coming up on the end of the year, how do you anticipate providing guidance for 2023? Could we see that maybe at a small investor conference in early January, or is kind of the 4Q call a more likely venue?
spk13: Yeah, when do you want to get that?
spk07: I think we're still a little bit undecided. Of course, we'll go through our usual procedures. We would have a budget approved in December, so we would know, but the exact timing of when it would be publicly available is a little bit uncertain at this point.
spk00: Okay. Okay, and last one, if I can. I'm just curious, guys. In the event of a complete response letter from the FDA, for Unberdimab this month, what do you see as the path forward for the program in the indication? Would you call it progress in the indication or do you think there's still a path forward here in the US?
spk09: That's a good question. I think we'd like to wait and see what that complete response letter would entail, what kind of comments they would have in it. But I do believe, you know, there could be a risk to that program depending on the outcome.
spk12: Okay. Thanks so much for taking our questions.
spk01: As a reminder, if you have a question, please press star 1. The next question comes from Joseph Tome of Cowan & Company. Please go ahead.
spk04: Joseph Tome Hi there. Good afternoon. Thank you for taking our questions. Maybe the first one, I'm Bertamad. Can you just remind us where you stand in terms of progress with DIPG and DSRCT and Does continued development in these indications kind of depend on the FDA outcome in NB with CNSLM?
spk09: So DS-RCT is a very small indication that it's at a Phase II trial at MSK enrolling a few patients. Yet DIPT closed the Phase I trial, and we were going to change. The plan is to change from 124 to 131 iodine. Obviously, we need to take a deep breath in and see what the FDA decides to do and reevaluate on Bertram as a whole and see where we end up after we get a response from the FDA.
spk04: Okay, sounds good. And then just to follow up on the prepared remarks, can you remind us what you said your assumptions were for Daniela's growth in your cash burn? I think you said maybe 10%, and is this sort of a formal guidance, or how should we think about that? Does that include any movement earlier in the treatment line or the implementation of the new infusion protocol?
spk07: The 10%, and I'm very happy that you're asking that question, the 10% is applied only for a conservative calculation of the cash runway. Of course, we hope to see a completely different growth rate in the coming quarters and the coming years. So it's just a matter of estimating our runway in a way where nobody is overly optimistic. So it's not constituting any kind of guidance. I'm just laying out the conservative assumption used for this specific calculation. Okay, that is helpful.
spk04: Thank you very much.
spk01: The next question comes from Sebastian Vanderschoot of Kempin & Company. Please go ahead.
spk08: Hi, guys. Thanks for taking my questions. Just on BootMap, can you maybe expand on what the current expenditure is on R&D costs for all the BootMap programs combined? And then can you maybe also give some guidance on when we can expect data for the bi-specific program? And maybe I missed it, but also for the SADA program. Thank you.
spk09: Bo, do you want to address the first on the spend question?
spk07: Yeah, yeah, yeah. Sebastian, I'll be happy to. I will not provide a specific number for you. We're not reporting per program for external programs. reporting purposes where we separate by the various sorts of activities conducted. But of course, historically, Umberta Map has been our second largest program. But as you've seen from our statements, the overall ID spending is quite modest. And even though we are taking this through to registration, we have invested nowhere near the sums that you have seen in the statistics for the oncology programs. We took this program over with a certain data set from MSK, so the overall investment is actually relatively modest, especially when you consider that we took it through to registration. Okay.
spk09: And to address the bispecific data, so we just started the pediatric, the PEAT-ALL with CD33, CD3. We've opened up two centers out of 17. Another four centers are opening shortly. So we've only dosed two patients so far, so that's going to take a while. Regarding SADA, as I said, you know, due to the pharmacokinetics and the imaging, you know, it's possible to de-risk these programs quite early on. So, you know, we are planning, depending on how it goes with dosing patients, of coming out with some data as soon as possible and hopefully sometime in 2023 or before. Okay, thanks very much.
spk13: Thanks.
spk01: The next question comes from Edward Malarkey of Guggenheim. Please go ahead.
spk03: Hi, thank you for taking my question. This is Edward on for Charles, and apologies if somebody already asked this. I got cut out for a bit, but just maybe for the SADA platform, I know you guided to starting dosing patients by the end of the year. Just maybe what remains there, and also for beyond GD2 SADA programs, just the cadence of INDs for other SADA targets, and maybe some color on the potential targets. I think in the past, you talked about sort of HER2 and maybe D7H3, if I'm not mistaken. So any color you could get there would be great. Thank you.
spk09: Yes, thank you. So right now, we are opening sites as we speak. So that's the gating factor for dosing patients. And we're pre-screening on Thanksgiving and in between, but we hope to dose the first patient in December. Regarding additional INDs, We're having an R&D day coming up December 14th, and I think we're excited to hold that R&D day with focus on Sara and Danielsa. So hopefully we'll be able to announce our second R&D by that date. Regarding partnerships, you know, we are very, very close to inpatient data at this point in time. So I think a validation in terms of scans is the next step. milestone in order to further validate this platform with third parties. We are constantly working with other companies, and we're also looking at failed targets that we could potentially optimize on a research collaboration with the SADA platform.
spk13: I hope that answers your question.
spk01: At this point, it seems that there are no further questions. I will now turn the call back over to Thomas Gad for closing remarks.
spk09: Yeah, thank you very much. This ends this call today. Thank you for your questions and for your time with us today on the call. Have a great day.
spk01: The conference is now concluded. Thank you for attending today's presentation. You may now disconnect.
Disclaimer