Y-mAbs Therapeutics Q2 2023 Earnings Call Transcript

Quartr
Provided by Quartr
August 11, 2023

There are 12 speakers on the call.

Operator

And welcome to the YN Labs Therapeutics, Inc. Earnings Conference Call for the Q2 of 2023. At this time, all participants are in a listen only mode. Instructions for the question and answer session will follow after the prepared remarks. As a reminder, today's conference will be recorded.

Operator

I will now hand it over to YM Labs' Head of IR, Corie Duveen.

Speaker 1

Thank you. 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 regulatory submissions regulatory, marketing an advancement of SADA, collaborations for strategic partnerships and the potential benefits thereof, expectations related to our anticipated cash runway and the sufficiency of our cash resources and assumptions related thereto, guidance and expectations for 2023 and beyond 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 risks 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 factors discussed in the company's quarterly report on Form 10 Q for the quarter ended June 30, 2023, as filed with the SEC on August 10, 2023.

Speaker 1

With that, I'd now like to turn the call over to our Founder, President and Interim CEO, Thomas Gadd.

Speaker 2

Thank you, Courtney, and good morning, everyone, and thank you for joining us today. Today I have with me our Chief Financial Officer, Bill Kruse our Chief Commercial Officer, Sue Smith and our Chief Medical Officer, Doctor. Vinesh Raja. In today's call, I'll begin by providing a review of our Q2 product sales and then the other highlights, updates on the additional nocitamab research currently underway. I'll also touch on key clinical highlights from the quarter and an update on our novel we targeted 2 step radiopharmaceutical platform, the SADA VIPRET.

Speaker 2

Vyness will then discuss further details our ISS programs on the Daniela as well as our progress on our SARA Phase 1 study, followed by Sue Smith, who will report further insights into our Daniela U. S. And ex U. S. Sales.

Speaker 2

Bo will then provide an overview of our Q2 financial performance, I'll cash position and reiterate our full year 2023 guidance, and then we'll open up the line for Q and A. Let me begin with a high level update on the year so far. As you know, we successfully implemented a strategic repurchaseation we have our pipeline focusing on Daniela and the SADA platform earlier this year. Our execution has been swift as our first half financials demonstrate, allowing us to extend our estimated cash runway into 2026. I'm incredibly proud of our team's resilience over the past several months and their steadfast dedication to realizing our mission of providing innovative therapeutic options in the fight against cancer, particularly pediatric cancers.

Speaker 2

As we look ahead to the rest of 2023 and beyond, we are in a healthy financial position with $87,900,000 in cash and cash equivalents at the end of the Q2 of 2023. We have a firm strategy in place that focuses on growing Daniela's net sales, which we believe will enable us to continue to we patience and investors alike. Let me turn to the highlights on our Daniela franchise. As a reminder, Daniela is approved by the U. S.

Speaker 2

FDA for the treatment of relapsed and refractory high risk neuroblastoma in bone and bone marrow for patients we've demonstrated a partial response, minor response or stable disease prior therapies. Neuroblastoma is the most common cancer in infants and the 3rd most common cancer in children. In the Q2 of this year, we achieved $20,800,000 in net product sales of Daniela more than double or 112% from what we recorded in the Q2 of 2022 and up 3% from our previous quarter. Additionally, we made significant progress on our commercialization efforts for Daniela and continue to gain momentum in the U. S.

Speaker 2

With a number of new accounts, we now have 56 sites activated across the U. S. We've been making significant progress outside the U. S. Marked by the recent regulatory approval of Daniela in Brazil.

Speaker 2

In May, we received approval in Brazil, where we have partnered with Adium, also Technopharma, for marketing in the region. Additionally, Cyclone launched Daniela in Greater China in late June, early July, further solidifying our presence in the Asian market. We firmly believe that the Asian market holds a great potential as an important revenue driver for Danielsson, and we look forward to updating you on the progress of these launches over the coming quarters. We also continue to see progress with our partnerships in Central Eastern Europe through Swyx Pharmaceuticals and Takeda in Israel and our distribution program through WEP in Europe. We continue to seek partnerships to expand our global commercial footprint even further, aiming to enable any patient who may benefit from Daniela to access it.

Speaker 2

This is the backbone of our mission at Ymabs to support children and families in the fight to beat cancer. We couldn't be more pleased with our first two quarters of Daniela, we are creating net sales of more than $40,000,000 in 2023 already and gaining market share in the U. S. We remain confident in our ability to continue to grow our commercial market footprint and meet our full year 2023 Daniela's net In addition to our partnering strategy for NANSA, we continue to collaborate with leading KOLs on investigator gator sponsored clinical studies we efficiently advance potential label expansions of etulis for Daniela. Vinesh will provide an update on our ongoing clinical trials with thought leaders at the Beat Childhood Cancer, Resource Consortium, MD Anderson Cancer Center and Ohio State University and Memorial Sloan Kettering Cancer Center.

Speaker 2

Now let's turn to SADA. On to SADA, our novel and highly differentiated pre targeted 2 step radiopharmaceutical platform in development that we licensed from Memorial Sloan Kettering and MIT in April 2020. With SADA, we are working to pre target the tumor with a protein only dose with rapid clearance of any on bound protein we are confident that we will be able to deliver on the bloodstream followed by a radioactive payload. We believe this mechanism offers the potential we substantially increased the amount of radioactive payload delivered to tumors, while simultaneously limiting normal tissue uptake and thus resulting in significantly higher therapeutic indices by potentially maximizing on target efficacy while minimizing off target side effects. Further, our 2 step dosing separates protein dose from the HOT payload dota case lutetium dose.

Speaker 2

This could simplify our supply chain and facilitate the use of Saba in large infusion centers if approved. The payload is not patient specific, making it possible to use the same payload for different SADA patients and different SADA constructs, potentially increasing the platform's accessibility and efficiency. We believe our SATA Wi Fi diagnostic platform, if approved, has the potential to drive significant supply chain improvements. Our first hopefully of many SADA constructs targeting GD2 enter the clinic this March. We are pleased to report that we have closed cohorts 12 and we are currently administering doses in Cohort 3 at 1 milligram per kilo.

Speaker 2

I can further say that we have now administered a 200 milligram therapeutic dose we have not seen any pain signals when dosing DD-two Sartner. We anticipate sharing PK and imaging data at our annual R and D Day in December. Our second development program derived from this platform is the CD38 construct. We have already conducted our pre IND meeting with the FDA and we anticipate submitting an IND application for this program in the Q3 of this year. Additionally, we are advancing a number of preclinical SADA targets and have made good progress on both our HER2 and B7 H3 constructs, on which we plan to provide an update on our R and D Day later this year.

Speaker 2

Lastly, a short update on our business development activities. As mentioned, we remain dedicated to expanding the global commercial footprint of Daniela through potential partnerships and ISS strategies. Regarding SADA WIPRIT, our current approach is multifaceted. We aim to advance internally some of the SADA constructs through at least Phase 2, while in parallel seeking to outlicense other targets. Additionally, we see an important opportunity to collaborate with 3rd party and their targets to introduce to the SADA platform and to explore targets from previously unsuccessful Phase III as we seek to maximize the potential of our platform.

Speaker 2

I would like to turn this call over to Doctor. Vinesh Raja. Thank you.

Speaker 3

Thank you, Thomas, and good morning, everyone. I'll first provide an overview of our ongoing naxitamab investigator sponsored studies, I assesses and I will discuss the latest updates on our SADA platform. So in the frontline high we are excited about our collaboration with Beat Childhood Cancer Research Consulting for a multicenter Phase 2 trial evaluating naxitamab in combination with standard induction therapy for patients with newly diagnosed high risk neoblastoma. Currently 9 sites have been initiated and 5 patients have been dosed. Study will however transition from a single arm study with naxitamab added to current standard treatment for induction, to a randomized study where the control arm will be the current standard of care for induction therapy, which is chemotherapy plus or minus ALK inhibitor, the clinical rationale for this study is based on the fact that patients who have a favorable response at the end of induction treatment have a much better prognosis.

Speaker 3

By increasing the number of patients who achieve a complete response following induction treatment, we can potentially improve overall survival outcomes. The purpose of this randomization is to compare the end of induction complete response rate between the two arms. Our aim is to show our superiority we intend to engage with the FDA to gain their insights on the study design and endpoints and hopefully get their alignment. We're also considering an interim analysis and its impact on the sample size. Patient recruitment for the trial is projected to start in the next several years, there's an anticipated total trial sample size of approximately 270 patients.

Speaker 3

This will include BCC centers in the U. S, Canada and Europe. At the moment, we're in the midst of updating the trial protocol, preparing for IND submission and working to schedule a regulatory meeting. We anticipate the new study to be initiated in Q1 2024. Moving to osteosarcoma, we are continuing to work with Memorial Sloan Kettering Cancer we are conducting a multi center investigator sponsored trial from axitamab.

Speaker 3

We expect data from this Phase III trial in Q3 of 2024. And if positive, we hope to then begin recruitment for pivotal Phase 2 trial. At ASCO in June of this year, we presented a pre specified interim clinical data on mexitamab in combination with GM CSF in patients with relapsed or refractory high risk neuroblastoma with residual disease limited to the bone and or bone marrow. The overall response rate was 50% and complete response rate of 38% as per INRC criteria. For the subset of patients with refractory and relapsed disease, the overall response rates were 58% 42% respectively.

Speaker 3

There were clinically meaningful reductions in QA scores ranging up to minus 18 in patients regardless of baseline disease status. At the AACR meeting in April we presented data on preclinical study conducted by MD Anderson Cancer Center showing that GD2 was up regulated in full negative breast cancer and its high expression is associated with the poor prognosis. This data led to our ISS study with Ohio State University for advanced breast cancer, whereby naxitamab will be BOST in combination with gemcitabine and NK Cells. Our strategy is to generate proof of concept data in humans with the aim to establish a solid tumor breast cancer franchise that could potentially attract strategic partnerships. We firmly believe in the potential of Nexitimab to aid in the treatment of a variety of cancers with significant unmet medical needs, both in pediatric and adult cancers, and we plan to execute and build upon the large commercial opportunity of MexivMAb Worldwide.

Speaker 3

Now turning to the latest updates on our SADA Wiprott Theranostic platform. In June, we presented our Phase 1 clinical study design evaluating SADA wipert for the treatment of certain GD2 positive solid tumors, including small cell lung cancer, sarcoma and malignant melanoma at ASCO. To reiterate, the Phase 1 dose escalation, single arm, open label, nonrandomized multicenter study had 3 parts. Part A explores dose finding for the GD2 SARD molecule and testing of dose intervals between the protein and the 177 Lutetium delta payload. Part B determines the optimal dose of 177 lutetium dota and Part C evaluates safety initial signs of efficacy using repeat dosing.

Speaker 3

Dose escalation is based on 2 patients in Cohorts 12, followed by classic 3 plus 3 design. The study is progressing well. We currently have 6 active sites and patient recruitment is ongoing. Particularly exciting is the news that we shared today that we have advanced through the cohorts to the point we have now given a 200 milliculiterapeutic dose of 177 Mutation DOTA using the dosing to develop 2 to 5 days based on optimal timing coming from our Honeywell studies. We are pleased with what we have seen so far, noting that we are still in early days, but are looking forward to providing an interim data update at our R and D Day later this year.

Speaker 3

Additionally, we remain on track to file an IND for our CD38 SADA program in non Hodgkin's lymphoma, focusing on T cell lymphoma, where an unmet medical need exists with the FDA in the Q3 of this year. We believe in the potential for Sartawiparib to become the targeted radiopharmaceuticals delivery platform of choice in the future, if approved, potentially altering the treatment landscape across a variety of cancers. I'll now hand the call over to Sue Smith to provide further color on our continued Daniela growth.

Speaker 4

Thank you, Zignesh, and good morning, everyone. I'm pleased to be speaking with you this morning about our commercial progress of Danielza. Our revenues in the Q2 reflect the team's execution on the strategic commercialization plan in action as we further expand our market footprint. The feedback we receive from physicians is truly remarkable. And as Thomas mentioned earlier, we are very pleased to see more and more physicians And new centers gaining experience with and seeing the benefits of Daniela for their patients.

Speaker 4

The strategic commercialization plan we have put in place includes 3 key initiatives and I'll speak to each one. First, we keep the patient at the center of everything we do. Our team has built on the strong momentum from the Q1 of this year and continued to put initiatives in place to further educate the market about the safe and effective use of Danielza. During the Q2, we continued to build upon our work to identify and support new patients, and as a result, have had 3 consecutive months of more than 30 patients in our hub, we added 3 new accounts using Danielza during the Q2. 12 physicians have prescribed Daniela and 12 new patients started treatment in the 2nd quarter.

Speaker 4

Additionally, we launched a strategic social media initiative to specifically target the average parent age of a child with neuroblastoma, which is typically apparent in their 20s or 30s, the launch of our Instagram in particular has been noteworthy as we roll out a steady stream of new and informative we demonstrate focused account teamwork. Following our restructuring announced earlier in the year, we've really seen what our realigned team can accomplish. And since the initial launch and as of June 30 this year, we've delivered Daniela to 56 centers across the U.

Speaker 3

S,

Speaker 4

a sequential increase of 6% in the number of centers versus the last quarter. During the Q2, 61 percent of vials sold in the U. S. Were sold outside of Memorial Sloan Kettering, consistent with our split in the Q1 of 2023. Our team continues to demonstrate professionalism and commitment to our mission of making Daniela accessible to patients.

Speaker 4

3rd is our ongoing commitment to customer support. We believe the increase in physician experience with Daniela that I mentioned earlier is in part due to the clear and consistent administration experience our team has put in place. This has led to 30% of our accounts having had 2 or more patients on Danielza since launch. Consistently executing against our strategy demonstrating a high level of excellence has led to Ymabs being recognized as the most committed pharmaceutical company in the high risk neuroblastoma space, with 88% of physicians treating pediatric neuroblastoma in the U. S, associating ymabs with a true commitment to the disease based on a recent survey we conducted among 17 physicians.

Speaker 4

We are a leader in this highly important area of pediatric cancer we have a 17% share of the U. S. Anti GD2 market as of the Q2 of this year. I'm very proud of this commercial team and I look forward to sharing our continued progress in future quarters. Let me now pass the ball to Beau, who will discuss our Q2 financial results in more detail.

Speaker 5

Thank you, Sue, and good morning, everyone. Our Danielson net product revenues of $20,800,000 in Q2 'twenty three increased by 3% sequentially compared to the Q1 of 'twenty three, which has revenues of $20,300,000 the increase was driven by international revenues and related royalties, including a $3,500,000 commercial launch inventory stocking order from cyclone, which we do not anticipate recurring at this level each quarter. Also, the increase was partly offset by a softening in the number of new U. S. Patients in the 2nd quarter and our $2,500,000 inventory stopping order from we will discuss WEP in the Q1 of this year.

Speaker 5

Daniela net product revenues of $20,800,000 $41,000,000 for the quarter and 6 months ended June 30, 2023, represented increases of 112% and 102%, respectively, over the $9,800,000 $20,300,000 reported in the comparable periods of 2022, the respective increases of $11,000,000 $20,700,000 were primarily driven by an increase in the number of new U. S. Patients And at incremental benefit from expanding international markets. Moving to operating expenses. Our research and development expenses decreased by $14,300,000 $23,800,000 to $12,100,000 20 we are now expecting $5,500,000 for the Q2 6 months ended June 30, 2023, respectively, compared to the same period last year.

Speaker 5

The net increase was primarily due to the decrease in spending on deprioritized programs in connection with our restructuring plan, which resulted in decreased outsourced manufacturing, outsourced research and supplies, clinical trials and personnel related costs. Selling, general and administrative expenses decreased by $11,800,000 $13,000,000 to 11.3 dollars 123,500,000 for the 6 for the 2nd quarter and the 6 months ended June 30, 2023, respectively, compared to the same periods last year. The decreases in SG and A for the 3 6 months ended June 30, 2023, we're primarily attributable to a $10,900,000 charge related to the departure of the company's former Chief Executive Officer in Q2 2022. Additionally, we recorded a restructuring charge of $1,100,000 in we will conduct a reconciliation of C and A during the 6 months ended June 30, 2023, in connection with the restructuring plan. Personnel related costs, inclusive of stock based compensation decreased in the 3 months ended June 30, 2023 compared to the corresponding period in 2022 due to the impact of the restructuring, we reported a net loss for the quarter ended June 30, 2023, of $6,300,000 or $0.14 per share basic and diluted compared to a net loss of 41,100,000 we are on $0.94 per share basic and diluted for the Q2 ended June 30, 2022.

Speaker 5

The improvement in our net loss was primarily driven by the increased revenues and growth of Daniela, coupled with decreased operating expenses in the Q2 of 2023. Additionally, we recorded a net loss for the 6 months ended June 30, 2023, of 12,700,000 or $0.29 per share basic and diluted compared to a net loss of $69,200,000 or $1.58 per share basic and we are committed for the 6 months ended June 30, 2022. The decrease in net loans was primarily driven by higher net product revenue, lower R and D expenses, lower SG and A expenses, inclusive of the $10,900,000 decrease for the Josh, related to the departure of our former CEO. As Thomas mentioned, we ended the 2nd quarter with cash and cash equivalents of $87,900,000 compared to $105,800,000 at year end 2022. The decrease was $17,900,000 year to date.

Speaker 5

Importantly, we reduced our cash used from $13,000,000 to dollars 5,000,000 or by 64 percent during the Q2 of 2023 compared to the Q1. We continue to demonstrate responsible cash management along with market expansion for Daniela, and our total cash burn for the full year 'twenty three is expected to be between $40,000,000 $50,000,000 We believe our cash and cash equivalents will be sufficient to support our commercial operations and pipeline programs as currently planned into 2026. As we noted in previous quarters, the underlying assumptions for this guidance are important to understand. No new partnerships all other new business development income are included in the assumptions. For the purpose of this analysis, I guess runway only, the Daniela product revenues are assumed to increase by 10% each year in 2024 and 2025.

Speaker 5

We indeed hope to see a higher growth rate for Daniela as we execute our refined commercial strategy and work to deliver the new clinical data that could potentially lead to our own expense and no new programs are assumed at this point for purposes of the analysis. No further development of the inverterumab program has been we continue we expect to achieve the financial guidance announced during our Q1 report as we anticipate full year Pzenosa net profit revenues to be in the range of $80,000,000 to $85,000,000 with a projected cash burn of $40,000,000 to $50,000,000 for the full year. And we continue to expect operating expenses between $150,000,000 $120,000,000 We believe Wyomash remains in a healthy financial position to execute our strategic mission, our priorities and to support the delivery of multiple milestones. Now this concludes the financial update. And I'll now turn the call back to Thomas.

Speaker 2

Thank you, both. Thanks for the overview. Let's open up the line for questions, operator, please.

Operator

At this time, we will be conducting a question and answer a confirmation tone will indicate your line is in the question And our first question comes from the line of Alex Stranahan with Bank of America. Please proceed with your question.

Speaker 6

Okay, great. Hey, guys. Thanks. Thanks for taking our questions. Just a couple from us.

Speaker 6

Maybe first for Sue, could you give us a sense of the patients coming on therapy versus coming off therapy in 2Q. And as we look to the back half of this year, essentially, if you want to meet guidance, you just need to sort of flat line that $20,000,000 or so per quarter. So is the expectation that the on off rate we'll be roughly equal in the second half. And then just a follow-up on the July Symphony data from Bloomberg, any guidance you can give around that? I noticed it was down sequentially month over month.

Speaker 6

And then I've got a follow-up. Thank you.

Speaker 4

Okay. Thanks, Alex, for the questions. In terms of the patients coming on and off treatment, we are looking to drive patients earlier to the induction failure. And so in terms of the right now, the majority of our patients are relapsed. And we anticipate the on off rate to shift slightly to a more an earlier patient based on induction New induction failure data that we hope to roll out.

Speaker 4

So that is a new marketing effort that we're working on And we hope to roll that out later this year and pending FDA approval of that. And secondly, in terms of the July SINPHAI data, we did see a little softening in the second quarter. I think really now after being here for a year and a half, we see a little seasonality in the spring. I think that truly what we hear from customers is the spring holidays and then the end of school time in June, some people kind of tap the brakes on treatment a little bit to have some normalcy. And I really do think that's what it is, in terms of the softening that we saw.

Speaker 4

But I remain confident that we have a real stable inflow of 30 plus patients per month in the HUB over the past 3 months and a growing ex MSK outside where 61% of our sales now Are outside of MSK. A year ago, 60% of our sales were at MSK, right? So we've done a flip. So I think that's really the perspective to take The foundation is strong, but we saw some seasonality.

Speaker 6

Okay. Okay. That's helpful. And then one quick one, if I may, just on the China launch. Could you give us a sense if any of the $3,500,000 sales from Cyclone, if any part of that was repeatable royalties yet?

Speaker 4

Thomas, do you want to speak to that one?

Operator

Well, I

Speaker 2

think Bo, do you want to speak to that one?

Speaker 5

Yes, I can. So, well, it's very early days with Cyclone and what they They've obviously faced their launch order with us during the Q2. It's quite substantial, Sold a little bit, so it's a combination of us selling wires to them and then sending us some royalties. And I think this is just an important point that with that transaction during the Q2 and the inventory stocking at WEP during the Q1, then essentially, we're seeing 20% of the revenues coming From outside the U. S.

Speaker 5

During the first half, and that's a quite substantial share. And it's hard to imagine that we will see exactly the same or more in terms of international Revenue is in the second half, and that's really why we maintain the guidance. Of course, we're expecting international income during the second half, But I think it would be maybe a little bit too optimistic to say that it will continue at 20% of the total product revenues. Okay. So that's how it comes about.

Speaker 6

Got it. All right. Thanks and congrats on the progress. Thank you.

Operator

Our next question comes from the line of Charles Sue with Guggenheim Securities. Please proceed with your question.

Speaker 7

Hey, good morning, everyone, and thanks for spending this call and for taking our Regarding GD2 SADA, correct me if I misheard, but it sounds like you've hit positive imaging data and subsequently dosed a patient at the therapeutic level of 200 millicuries. One clarifying question on this. Are you imaging only at the imaging dose or are you also reimaging at 200 millicuries? And if you're not, is there sufficient resolution at

Speaker 2

Yes. Thank you, Charles. So I'll just high level say that, When we see tumor uptake, the protocol has been designed to move the patient to a repeat protein dose and then a 200 milligram dose, so that's what happened with the patient. But I would like to relay this question over to you, Manesh, and then provide a little more color and then look forward to the more details update in the

Speaker 3

Yes. By inference, when we say 200 patient has been dosed to 200 millicuri, That's on the basis that a patient has shown positive imaging uptake as per the protocol. So as you as mentioned earlier on, we've gone through Cohorts 12, and we are now in Cohort 3 with a higher dose of SADA protein at 1 milligrams per kilo. In terms of your other question, the imaging dose of radioisotope is 30 millicury And the therapeutic dose for this Part A at least is 200 millicurae. There is no planned imaging straight after the therapeutic dose, But there's sufficient granularity and imaging quality coming from the 30 millicurid dose, at least to address the question that we have in terms of uptake in the vital organs and also clearance from the system.

Speaker 3

So again, we're all evaluating this as we go forward. It's still very early stages And we'll provide more data when we provide more mature information at the end of this year in the R and D Day.

Speaker 7

Sounds great. Thanks for that color and thanks for taking our questions and happy Friday.

Speaker 2

Thank you.

Operator

Our next question comes from the line of Mike Ulz with Morgan Stanley. Please proceed with your question.

Speaker 8

Hey guys, thanks for taking the question. Maybe just a bit of a follow-up on the launch is outside the U. S. And maybe you could talk about your thoughts on those market opportunities relative to the Over the long term? Thanks.

Speaker 2

Yes. So talking about Cyclone, our partnership in China and the approval that we got back in December and they have now announced they launched the product over there, I think, late June, early July. So it's Very, very new for us. But we do think that it's it's going to be a material market for us going forward, but it's too early to get some color on how that's So we look forward to having 2 or 3 quarters. We know it's initially a 40 hospital in that market is obviously fairly new.

Speaker 2

I think the first GD2 antibody was introduced 9 months ago and we are the 2nd on the market Shortly thereafter, so that's exciting as well. Okay. Thank you. With Brazil, we are currently in negotiations on pricing. And once that settles, we look forward for ADM to launch there.

Speaker 2

You know, Brazil is approximately 50% of South America. That is also an exciting market for us. And our I think we are very pleased with the progress of our WEP named patient program in Europe and as well with Takeda in Israel and Swyx Pharmaceuticals in Eastern Europe. So it's nice to see ex U. S.

Speaker 2

Sales also

Operator

our next question comes from the line of Bill Maughan with Canaccord Genuity. Please proceed with your question.

Speaker 9

Good morning and thanks. So looking down the line at a first line indication for Daniela eventually. So if the study if the induction study is positive and eventually you have a label. Obviously, you'll be one of 2 GD2s in the first line, but there'll be different settings in the first line, induction versus consolidation. So given that it's not just 2 options in a head to head competition for treatment all else being equal, I just want to get your commentary on how you see the competitive dynamic playing out when you have 2 different drugs or kind of 2 different strategies for attacking first line neuroblastoma?

Speaker 2

Yes, thanks. I mean, I can high And then Vinesh, maybe you can follow-up through. I think the market is currently looking at introducing GD2 antibody upfront and at the same time discussing the need for bone marrow transplant. So I think maybe the whole GD2 market is swearing towards induction and I will let Binesh talk a little bit about more of the trial design and how it Precision versus the traditional frontline.

Speaker 3

Yes. I mean the clinical landscape is definitely moving towards looking at the combination of chemo immunotherapy, both at the induction as well as the consolidation stage, partly to maximize response seen at the end of induction, which is as I alluded to earlier, this has been correlated with positive survival outcomes or improved survival outcomes. And in the consolidation setting, there is increasing awareness and consensus that potentially combination of anti GD2 plus current standard treatment of chemotherapy may be as good as or equivalent to stem cell transplants. So these are discussions still very early at this stage, but I think the scientific community is now looking to see how that landscape of anti GD2 entering in the both induction and consolidation setting in order to improve the safety profile and the safety outcomes of patients is definitely there. And as far as Nexitimab specifically concerned, we are definitely prioritizing the development of NexoMab has remained a randomized study looking at how the combination of NexoMab plus standard induction chemo compares to just standard induction chemo.

Speaker 3

This seems to be the way forward now and the aim is of course to maximize a complete response rate. A recent COG study report confirmed as a publication, which showed how a combination of well, not a combination, but at least maximizing treatments in these setting led to superior event free survivals Based on looking at QE scores before and after and they go on to conclude that further improvements in survival outcome we'll depend on improved induction therapy regimens with agents like anti GD2 antibody. So the landscape is definitely evolving in that direction. Yes, I can't say anything more specific than that because trial discussions still ongoing with the COG and the BCC.

Speaker 9

Understood. And as a quick follow-up, so looking at the Brazil launch, from having I've seen other drugs that are reimbursed in Brazil. Sometimes just given the government pay dynamics, the ordering and revenue can be very choppy. Is that what you expect out of Daniela in Brazil? Or do you expect More of a curve where volume and demand matches revenues?

Speaker 2

Yes. No, we expect pending successful negotiations with SeaMet on pricing. We do not expect any CHOB reimbursement and but it's still ongoing. Okay, great. Thanks.

Operator

Our next question comes from the line of Tess Romero with JPMorgan. Please proceed with your question.

Speaker 10

Good morning, guys. Thanks so much for taking our question. In terms of the ex U. S. Ex U.

Speaker 10

S. Split here to reach your $80,000,000 to $85,000,000 guidance, what is your current expectation as to how this will split out? Do you still think it should be kind of in the mid-70s in the U. S. Here?

Speaker 10

And then another launch follow-up for us. To be clear, July Symphony was down 47% month over month. Are you suggesting that you think this will pick back up in August? And even last summer, we didn't see any seasonality in Daniela based on the Symphony data that is available to us. Thanks so much.

Speaker 2

I guess I'll take the first one. Yes, I do think we are comfortable in seeing mid-70s in U. S. And then the remainder from ex U. S.

Speaker 2

Sales. I don't know Bo or Sue, if you want to comment on the SYMPEGENT?

Speaker 4

Yes. This is Sue. Yes, I think we do. I think that the stability is there And that we do expect it to pick back up. We also have some new campaigns in development that we're very excited about.

Speaker 4

I'm anticipating we will hit this number this year with the things that we have in place.

Speaker 10

Okay, great. Thanks so much for taking our questions.

Operator

Our next question comes from the line of Edsair DeRout with BMO Capital Markets. You proceed with your question.

Speaker 11

Hi. This is Luke Chamonix on for Esther. Thanks for taking my question. Just one for me. Looking at the PK and imaging data for SADA later this year, how should we think about benchmarking that?

Speaker 11

And what are you thinking about It's a gono go for that program.

Speaker 2

So thanks, Etta. So what we are trying to achieve by December is we are trying to see PK curves and imaging data, meaning we are trying to validate the mechanism of the SADA platform in terms of having the protein binds a tumor while rapidly clearing unbound proteins from the bloodstream and at the same time being able to scan the tumors with the 30 milligram isotope dose. I think That's what we are aiming at for December, and I think that would be a success internally for us.

Speaker 11

Okay. Thank you.

Operator

And our next question comes from the line of Sebastian Vanjersuit with Kempen. Please proceed with your question.

Speaker 3

Hi, everyone. Thanks for taking my questions. I'm just wondering if you can comment on

Operator

the type of centers that are going to

Speaker 3

enroll the frontline study in

Speaker 2

Vinesh, why don't you take that?

Speaker 3

Yes, I didn't catch that question clearly. Can you repeat that, please?

Speaker 2

He was asking about the BCC study, number of centers, potential data readout and patient numbers.

Speaker 3

Yes. So as I mentioned earlier, we have a current ongoing study, which is a single arm Phase 2, which we are aiming to transition to I study that could potentially lead to a label expansion and that transition we anticipate to take place in quarter 1 next year. So what will happen to the patients in the current ongoing recruitment study? Well, of course, contribute overall safety evaluation of the combination and induction. The proposed new randomized study will include a number of sites which are affiliated with the BCC network, which is currently about 50 sites in U.

Speaker 3

S, Canada and also they have site in Europe. They're also very keen to expand it out to other centers internationally outside of the U. S. To accelerate the recruitment for this randomized study. The protocol is still in draft stage at the moment.

Speaker 3

But as I mentioned earlier on in the presentation part, we are looking at approximately 2 70 patients in total to be randomized in the study. We anticipate that will take anywhere between 4 to 5 years to complete enrollment. And based on the data, I'm also looking at the possibility of income analysis and how that will impact as well. All of this is subject, Of course, to discussions with the FDA, which we are planning later this year. And subject to all this data coming through being positive, yes, as I mentioned, we hope this will lead to sufficient data to expand our label on axilomab in induction treatment.

Speaker 3

Does that answer your question?

Operator

And we have reached the end of the question and answer session. I'll now turn the call back over to management for closing remarks.

Speaker 2

Thank you. And thank you everyone for joining us today. Happy Friday. Have a great weekend. This concludes our call.

Operator

And this does conclude today's conference and you may disconnect your lines at this time. Thank you for your

Powered by Quartr
Earnings Conference Call
Y-mAbs Therapeutics Q2 2023
00:00 / 00:00