Y-mAbs Therapeutics Q1 2024 Earnings Call Transcript

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Provided by Quartr
May 8, 2024

There are 9 speakers on the call.

Operator

Good morning, and welcome to Ymabs Therapeutics Inc. Earnings Conference Call for the Q1 of 2024. At this time, all participants are in a listen only mode. Instructions for the question and answer session will follow the prepared remarks. As a reminder, today's conference will be recorded.

Operator

I will now hand it over to YmAb's Head of IR, Courtney Dugan.

Speaker 1

Thank you, operator, and good morning, everyone. Welcome to the Ymab's Q1 2024 financial results conference call. We issued a press release yesterday at market close. The press release and accompanying slides are available on the IR section of our website. 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.

Speaker 1

Such statements include, but are not limited to, statements about our business model and development, commercialization and product distribution plans, expectations with respect to early trial data, 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 and reimbursement approvals, including statements with respect to future development of other development programs potential for Daniela's territory and label expansion and potential of and advancement of SADA collaborations or strategic partnerships and the potential benefits thereof expectations related to our anticipated cash runway and cash burn and the sufficiency of our cash resources and assumptions related thereto guidance and expectations for 2024 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 risk factors discussed in the company's quarterly report on Form 10 Q for the quarter ended March 31, 2024, as filed with the SEC on May 7, 2024.

Speaker 1

I would now like to turn the call over to our President and Chief Executive Officer, Mike Rossi.

Speaker 2

Thank you, Courtney. Good morning and thank you for joining us. I have with me today our Chief Financial Officer, Beau Cruz our Chief Commercial Officer, Sue Smith and our Chief Medical Officer, Doctor. Vinesh Srivijal. Thomas Gadd, our Founder and Chief Business Officer will join us for the Q and A portion of this call following our prepared remarks.

Speaker 2

This morning, I will start off by reviewing key financial highlights from the Q1 of 2024, including Daniella's sales performance and the clinical progress of our radiotherapy clinical programs, utilizing our self assembly disassembly pre targeted radio immune therapy or SOTAPRIT technology platform. Next, Sue will provide details around our global Danielson sales in the Q1. Vinesh will then provide updates around our ongoing naxitamab ISS clinical trials. Paul will then provide an overview of our Q1 of 2024 financial performance, our cash resources and reiterate our full 2024 guidance before we open the line for Q and A. Let's begin with key highlights for the Q1 of 2024, starting with Daniela.

Speaker 2

As a reminder, Daniela is approved by the U. S. FDA for the treatment of relapsed or refractory high risk neuroblastoma in bone or bone marrow for patients who have demonstrated a partial response, minor response or stable disease with prior therapies. Neuroblastoma is the most common cancer in infants and the 3rd most common cancer in children. In the Q1 of 2024, we achieved record U.

Speaker 2

S. Net sales product sales of Daniela of $18,600,000 up 11% from what we recorded in the Q1 of 2023. We achieved record demand in vials sold of Daniela by further penetrating the top high volume centers across the U. S. We expect this positive momentum to continue throughout the year.

Speaker 2

From a worldwide standpoint, we achieved Global Danielle's net product sales of 19.4 $1,000,000 in the Q1 of this year, a 4% decrease from the same period in 2023. While the decrease was primarily driven by lower product purchases from international markets in the Q1 of 2024 compared to the prior year as expected, Our Q1 total net product revenue came in ahead of our internal projections. We remain confident in our full year 2024 revenue guidance as we continue to grow momentum in the U. S. And with our partners in ex U.

Speaker 2

S. Markets. We have 63 sites activated across the U. S. To date with 5 new accounts added in the Q1 of this year.

Speaker 2

Our U. S. Commercial team has been doing a fantastic job of continuing to penetrate high volume centers and increasing physician adoption of Daniela. In addition to the U. S, our ex U.

Speaker 2

S. Footprint continues to expand through multiple partnerships. Danielle's is approved and has been launched in China through our partner, Cyclone, and has been recently launched by our partner, Adium, in Brazil and Mexico just a few weeks ago. We look forward to providing further updates on these launches in the coming quarters. Our European named patient program with Web clinical is continuing to progress as we support the needs of children with high risk relapsed and refractory neuroblastoma in Europe.

Speaker 2

In addition, we plan to submit a BLA for Danielza in Argentina this year and could potentially receive an additional approval in Asia and Hong Kong next year. We continue to see progress among our ongoing ISS naxitamab trials in support of our indication expansion strategy. In particular, we look forward to Memorial Sloan Kettering's readout from its multicenter Phase 2 trial, investigating naxitamab in patients with relapsed osteosarcoma as we anticipate in the Q4 of this year. You will hear more about the progress of the ongoing investigator sponsored trials of naxitamab from Vinesh later during this call. Now let me shift to the clinical progress for SADA prit programs.

Speaker 2

Phase 1 GD2 SADA. Our 1st SADA PrEP clinical program is our GD2 SADA, which is in Phase 1 evaluating its safety and tolerability. And that is in the treatment of GD2 positive solid tumors, including small cell lung cancer, sarcomas and malignant melanoma. This Phase 1 dose escalation single arm multicenter safety study has 3 parts, which you can see here. Part A explores dose finding for GD2 SADA molecule and the testing of dose intervals of 2 to 5 days between the protein and the lutetium dota payload.

Speaker 2

Part B determines the optimal dose of Lutetium DOTA and Part C evaluates the safety and initial signs of efficacy using repeat dosing. We are currently in Part A and are very pleased with how the trial is progressing. We have advanced through cohorts 1, 23 and are now dosing patients in Cohort 4. We have dosed a total of 14 patients to date in this trial. We currently have 7 sites open and plan to continue adding additional sites.

Speaker 2

Recall that Part A of the trials investigating the safety profile of the protein and determining the optimal timing to administer the radionuclide. The evaluation is still ongoing. We remain very encouraged by what we've seen so far. To date, no patients in the trial have experienced any dose limiting toxicities and there have been no instances of treatment related serious adverse events. Based on the spec CT scans and PK activity we have seen to date, we believe we have demonstrated proof of concept that GD TUSADA can both find and bind to tumors.

Speaker 2

It is important to note that this early data is not complete and are not necessarily indicative of the full results or the ultimate success of the trials or the SADA development program. We expect to complete Cohort 5 of Part A component of Phase 1 study by the end of this year and look forward to present the full dataset from Part A at a medical meeting in late 2024 or 2025. Our second SADA PrEP program is the CD38 SADA, which we plan to first study in the treatment of non Hodgkin's lymphoma, focusing on B and T cell lymphoma. This will be our 1st SADA program in circulating tumors. Our planned Phase 1 follows a comparable design to our GD2 SADA Phase 1 trial, which you can see here.

Speaker 2

We're on track to activate the first two sites in the Q2 of this year and expect recruitment of patients to follow the closing of the contracts. We are incredibly excited by the opportunity of our SODAPRIT platform to potentially shift the treatment paradigm across a variety of cancers potentially even indications beyond oncology. We look forward to providing further updates on our SODAPRIT programs and clinical progress throughout the year, including at the ASCO Annual Meeting and the Society of Nuclear Medicine and Molecular Imaging or SNMMI Annual Meeting, which both occur in June. Shifting gears a bit, I want to take a moment to acknowledge Beau Cruz.

Speaker 3

As you likely saw

Speaker 2

in March, we announced Beau's resignation as CFO of Y Mabs. Beau has served as a CFO for nearly 10 years and has been a valued member of our leadership team throughout his tenure. He has ensured that Ymabs is in a strong financial and operational position as he soon transitions out of the role and supports us in search of a new CFO. I want to thank Beau for his dedication to Ymabs and his strategic partnership. We wish him all the best as he embarks on his next career journey.

Speaker 2

Additionally, in March of this year, we entered into a separation agreement with our Chief Scientific Officer, Dean Lisby. The separation agreement did not result in material impact to our financial statements. We wish Doctor. Lisby good luck with future endeavors. Our search for a new Chief Scientific Officer is ongoing with a focus on the continued advancement of our novel radiopharmaceutical platform.

Speaker 2

I'm incredibly confident on our entire team as we currently have in place here at Y Mab and I'm really proud of the commitment to patients that each and every one of our team members demonstrates every day. We remain focused on our mission to improve patient lives and execute on our strategy to advance novel therapies through clinical development. I will now pass the call over to Sue Smith to provide further color on Global Daniela's sales for the Q1 of 2024.

Speaker 4

Thank you, Mike, and good morning, everyone. I'm really pleased with the commercial progress of Daniela on global scale so far this year. Building on momentum from last quarter, we continued to see the fruits from our enhanced marketing efforts during the Q1. Let me begin with our commercial progress in the U. S.

Speaker 4

During the Q4 of last year, we rolled out a new Daniela campaign in the U. S. Aimed to reposition and elaborate on Daniela's differentiating characteristics in the treatment of high risk neuroblastoma for patients who have experienced incomplete response to induction therapy in their bone and bone marrow. This new campaign allows us to share our data for refractory versus relapse patients separately and provide more detailed data regarding Daniela's performance in 2 different patient populations, those patients with an incomplete response to induction therapy and patients who are relapsed after prior therapy. The new campaign also demonstrates Daniela responses in children re challenged with Daniela after prior GD2 therapy.

Speaker 4

We continue to expect to see meaningful traction from the new campaign over the coming quarters. Our Q1 2024 U. S. Danielza net product revenues increased 11% year over year to 18,600,000 dollars The U. S.

Speaker 4

Accounts for more than 80% of Daniela's sales and Q1 of 2024 marked a record high in terms of U. S. Daniela demand and vials sold. In the U. S, we achieved sales well above the Q1 portion of our internal forecast with the highest ever number of vials sold in a quarter since initial launch back in 2011 2021, sorry.

Speaker 4

In the Q1 of 2024, U. S. Sales measured in vials were 9% higher than the Q4 of 2023, and March 2024 was the highest month of vial sales in the U. S. Ever.

Speaker 4

Bo will provide further color later during the call. Further, the team is focused on multiple U. S. Key activities driving performance in the Q1 and beyond. In the Q1 of 2024, the marketing team launched an accompanying enhanced digital campaign.

Speaker 4

The field sales team is hard at work educating customers on the new data, contributing to Daniels' continued growth outside of MSK with 16% growth in the first quarter of this year versus Q4 of 2023. The commercial team also engaged with our key customers with active presence at meetings such as ASFO, AFON and tandem transplant meeting during the Q1. A total of 63 accounts have now used Daniela's around the U. S. Since its initial launch in 2021, with 5 new accounts added in the Q1 of 2024.

Speaker 4

February 2024 marked the highest number of active sites in I'm sorry. My computer just stopped. The highest number of active sites in a single month since initial launch. My apologies. We continue to increase share of sales outside of MSK and now count 60% of ex MSK sales compared to 55% of sales ex MSK in the Q4 of 2023.

Speaker 4

In fact, our ex MSK sales were the best ever in the month of March 2024. Physician utilization of Danieleza also continues to grow. 18 healthcare practitioners started a patient on Danielza in the Q1 of 2024. Since launch, a total of 106 HCPs have prescribed Danielza and 31 HCPs have started treatment on 2 or more patients as of March 31, 2024. Our U.

Speaker 4

S. Commercial sales team continues to receive positive HCP feedback on Danielza through ongoing customer interactions. In addition, we continue to see institutional adoption of Danielza, which was added to 3 hospital formularies in the Q1 of 2024, bringing the total since launch to 44 hospital formularies as of March 31, 2024. We continue to see an upward trend of sales growth in the U. S.

Speaker 4

Since initial launch as DANIELZA positively impacts patient lives in a highly important area of pediatric neuroblastoma. And it remains a leading therapy in the U. S. Anti GD2 market, we believe we have room for continued growth. Now let's turn to our global commercial progress.

Speaker 4

Our Q1 of 2020 4 total Danielza net product revenues decreased 4% to $19,400,000 versus the Q1 of 2023, primarily driven by timing in international purchases. Despite this 4% decrease, total product revenues came in above our internal remains steadfastly focused on further market penetration to bring Daniela to more pediatric high risk neuroblastoma patients. We continue to receive positive feedback and physician uptake of Daniela in China through our partner Cyclone. During the Q1 of this year, our South American partner Aedium came to an agreement with the Drug Market Regulation Chamber or C MED on the price of Danielson Brazil and launched in both Brazil and Mexico just a few weeks ago. We look forward to updating you on our continued global commercial progress in the coming quarters and we remain confident in reaching our total Daniela net product sales guidance for the full year of 2024 of between $95,000,000 $100,000,000 Let me now pass the call to Vignesh.

Speaker 5

Thank you, Sue. Hello, everyone. I'm pleased to provide a brief update on our ongoing naxitamab clinical trials. We continue to advance potential label expansion opportunities for Daniela Zo through our investigator sponsored clinical studies in collaboration with leading KOLs. In the frontline high risk neuroblastoma setting, our partner, the Beat Childhood Cancer Research Consortium or BCC is conducting a multicenter Phase II trial evaluating naxitamab in combination with standard induction therapy for patients with newly diagnosed high risk neuroblastoma.

Speaker 5

16 sites have been open and recruitment is ongoing. The trial is expected to transition from a single arm study with naxitamab added to the current standard of treatment for induction to a randomized trial where the control arm will be the standard of care for induction therapy, which is chemotherapy, for which we plan to file an IND. Our aim for that randomized trial is to demonstrate superiority in complete response at the end of induction therapy in the naxitamab arm versus standard of care. The BCC expects to potentially initiate the new randomized study in the Q2 of this year. In osteosarcoma, we are working with Memorial Sloan Kettering Cancer Center on its multicenter investigator sponsored trial for naxitamab.

Speaker 5

We continue to expect MSK to provide a data readout from this Phase III trial in the Q4 of this year. And based on the outcome of this, we will evaluate plans for our pivotal randomized trial anticipated to be initiated in the second quarter. In breast cancer, we are partnering with the Ohio State University on a Phase 1btwo trial investigating TGF beta NK cells, gemcitabine plus naxitamab in patients with GD2 positive metastatic breast cancer. The first patient is expected to be dosed with Danielle's in the Q2 of this year. Upon the outcome of this trial, we will consider moving forward with a multicenter Phase 2 trial.

Speaker 5

In addition, we have partnered with the Institute of Mother and Child in Poland on a randomized Phase II trial evaluating the efficacy and safety of naxitamab in patients with refractory Ewing sarcoma, which is initiated during the Q4 of 2023. Recruitment is ongoing and 3 patients have been dosed in the naxitamab arm to date. We expect a total of 16 patients in that arm. The trial is expected to be completed in 2028. A significant treatment gap remains in the anti genitur space in both pediatric and adult cancers.

Speaker 5

We are committed to supporting the advancement of these investigator sponsored studies through clinical development and working to unlock the full potential value of naxitamab. We look forward to updating you on our progress at ASCO later this month and in the coming quarters. Let me now hand the call over to Bo Cruz.

Speaker 6

Thank you, Vignesh, and good morning, everyone. As you heard from Mike and Sue, U. S. Revenues increased 11% to $18,600,000 in the 1st quarter compared to $16,800,000 in the same quarter of 2023, while international revenues decreased by 2,600,000 dollars to $800,000 in the Q1 compared to $3,400,000 in the Q1 of 2023. The decline in international revenues was driven by our distribution partner with Clinical, which generated revenues in the Q1 of 2023 of $2,500,000 due to an initial inventory stocking order compared to no revenues in the Q1 of 2024.

Speaker 6

Our global Danielson net product revenues of $19,400,000 in the Q1 2023 represented a 4% decrease compared to the same quarter of 2023. U. S. Danielza net product revenues increased 3% compared to the quarter ended December 31, 2023, when excluding the $300,000 $1,300,000 impact from Medicaid accrual change in estimate recognized as increases in net product revenues in the quarters ended March 31, 2024 and December 31, 2023, respectively. The Danielson net product revenues of $19,400,000 in the Q1 of 2024 represented a 17% decrease compared to the Q4 of 2023 and was primarily driven by the decreased international revenues.

Speaker 6

We reported $500,000 worth of license revenues in the 3 months ended March 31, 2024, and did not have license revenue for the 3 months ended March 31, 2023. Moving to operating expenses. Our research and development expenses decreased slightly by 1000000 to 13,300,000 for the 3 months ended March 31, 2024, compared to the same period in 2023. The decrease was primarily due to a decrease in personnel costs related to our restructuring charge recorded in the quarter ended March 31, 2023, partially offset by a $2,500,000 increase in clinical trial cost due to our investments in our cytoplasmid programs in 2024. Selling, general and administrative expenses decreased by $800,000 to $11,400,000 for the 3 months ended March 31, 2024, compared to the same period in 2023.

Speaker 6

The decrease in SG and A for the quarter ended March 31, 2024 was primarily attributable to decreased personnel costs related to the restructuring charge recorded in the quarter ended March 31, 2023. We reported a net loss for the quarter ended March 31, 2024, of 6,600,000 dollars or $0.15 per share basic and diluted compared to a net loss of $6,400,000 or $0.15 per share basic and diluted for the quarter ended March 31, 2023. As mentioned earlier, we ended the Q1 with cash and cash equivalents of $75,700,000 compared to $78,600,000 at year end 2023. The decrease was $2,900,000 for the quarter. Importantly, we reduced our quarter cash used from $13,100,000 to $2,900,000 or by about 78% year over year in 2024 compared to 2023.

Speaker 6

Turning now to our guidance. We are reiterating our full year 2024 guidance. We continue to expect full year 2024 total Danielza net product revenues to be in the range of $95,000,000 to 100,000,000 dollars We anticipate operating expenses to be in the range of $115,000,000 to $120,000,000 and we expect a cash burn for the full year 2024 of between $15,000,000 $20,000,000 We continue to expect our cash and cash equivalents to support our commercial operations and pipeline programs as currently planned into 2027. As we noted in previous quarters, the underlying assumptions for this guidance are important to understand. For the purpose of this specific analysis of cash runway only, the Danielson net product revenues are assumed to increase by 10% each year from 2024 through 2027.

Speaker 6

We hope to see a higher growth rate for Daniilza as we execute our refined commercial strategy and work to deliver new clinical data that could potentially lead to expanded indications and greater physician adoption. In terms of development activities, we have assumed that all of our programs will be advanced at our own expense. No new programs other than our planned studies and trials are assumed at this point for the purpose of this analysis. With a strong balance sheet and focused strategy, we believe YMAPS is well positioned anticipated milestones ahead. Now this concludes my financial update, and I'll now turn the call back to Mike.

Speaker 2

Thank you for that overview, Bo. Now let's open the line for questions. Operator?

Operator

And our first question comes from Alex Stranahan from Bank of America. Please go ahead, Alex.

Speaker 7

Hey, guys. Thanks for taking our questions. Just a couple for me. Maybe first for Sue, where do you see most of the current and near term Daniela growth coming from? Is it from activating new centers or is it from repeat use from physicians who have already treated patients previously with Daniella?

Speaker 7

And how are you maybe positioning your new marketing efforts to drive this? And then I've got a follow-up.

Speaker 4

Good morning, Alex. Thanks for the question. The marketing mix for us is a combination of both of the things that you said. I think the majority of the sales is coming from driving more use in the high volume centers, which is a very big focus for us. And as you heard, we've been added to several 3 new formularies in the Q1, which we're pulling through.

Speaker 4

So we're very excited about that. The new campaign is also opening up greater education around that part the partial response to induction patient, which is another important lever for us this year. And the new campaign does a very nice job of demonstrating our data and value in that setting. So, we increased the breadth and the depth in the treatment with existing and new accounts. And I think I'm sorry, what was the second part of your question?

Speaker 7

I think you answered it, it's just how you're positioning the new marketing efforts.

Speaker 4

Yes. Again, it's demonstrating our value in 2 different parts of the patient journey. The patients that have incomplete response to induction separate from the later stage after frontline where they have a relapse after prior treatment.

Speaker 7

Okay, great. That makes sense. And then maybe one for Mike. You mentioned in your prepared remarks potential to expand SADA beyond oncology. I wonder what that can sort of look like and whether there's any example applications you can provide, maybe based on your preclinical work?

Speaker 7

Thanks.

Speaker 2

Alec, thank you. As we look at radioactive material and what we do from both the diagnostic and the therapeutic, there's opportunities to look at multiple receptor modulated diseases. Where we started in the agnostics 80 years ago was in endocrinology and treating hyper thyroidism. So before it went on to thyroid cancer. So as we look at this many receptor modulated diseases where you need to either decrease the receptor response or to just decrease the overall production of hormones, things like that, you have the opportunity to treat with radioactive materials and treat in a very safe and effective way.

Speaker 2

So I wouldn't limit us to just oncology and as we look at the opportunities that lie ahead for these products.

Speaker 7

Great. Thank you.

Speaker 2

Thanks. Thank you, Alex.

Operator

And our next question comes from Bill Mahan from Canaccord Genuity. Please go ahead, Bill.

Speaker 8

Hi, thanks for taking the question. Good morning. I just wanted to take a quick look at ex U. S. Daniela.

Speaker 8

Understanding that bulk ordering and timing of those orders can affect revenue numbers, do you have visibility into vial sales, underlying demand? And then just kind of going forward, do you expect we appreciate that Danielle's is being broken

Speaker 2

out U. S. Versus ex U. S. Now.

Speaker 2

Do you

Speaker 8

expect U. S. To be remain clearly the main driver going forward? Or will the rest of the world at some point take some more share of the growth story here?

Speaker 2

Bill, thank you for that. And I will let Sue answer the majority of it. But what I will say is, as we look at this, we have visibility to some of the bulk orders coming in for the remainder of the year ex U. S. So we're very confident in our forecasting and where we are.

Speaker 2

Now there will be additional growth as we move into these launch markets and have some real opportunity to continue to grow. I think as you look at this, we're in the eighty-twenty range today with U. S. And ex U. S.

Speaker 2

With U. S. Being the driver. U. S.

Speaker 2

Will continue to be in the driver's seat. And because as we continue to grow the U. S, we'll continue to grow the ex U. S. Market.

Speaker 2

But as a direct market, without massive spread moving forward. But we may see some additional contribution from the ex U. S. Market beyond the U. S.

Speaker 2

As the U. S. Does tend to mature over a period of time. And Sue, if there's anything that you'd like to add?

Speaker 4

I think you said it well. I think we do have meetings regularly with all of our partners. So we have a very good line of sight in terms of the breakout of their assumptions for their forecasts and also the activities that they are doing to drive Adium and their ongoing sales in the case of Cyclone and others. So our company is well aligned to their stakeholders at other partner companies and have an ongoing dialogue in terms of the details behind the numbers. So and I agree with what Mike said in terms of the breakout of the eightytwenty.

Speaker 4

And I think everyone knows the U. S. Is the biggest market in terms of the top and bottom line contribution, which probably will not change moving forward.

Speaker 8

Okay. And then, just in the U. S, obviously, Danielle is a more important drug to Ymabs than unituximab to Unite Therapeutics. So as you continue to grow market share and more doctors start to write Daniela, Do you are you sensing sort of additional counter detailing or pushback from the other competitor on the market? Or do you feel that your share gains are just kind of being tolerated and you can continue to grow along

Speaker 2

the plans that you're implementing?

Speaker 4

Well, I think our growth speaks for itself. And we do not hear, it's my understanding that they do not have a sales force. So I think our share of voice is the greatest and for So, we continue to, to build So, we continue to build those relationships with the key accounts, and we're not hearing a lot of noise from U. S. WorldMeds.

Speaker 8

Great. Thank you.

Operator

And our next question comes from Etzer DeRout from BMO Capital Markets. Please go ahead, Etzer.

Speaker 2

Hi, this is Lucan for Edsir. Thanks for taking my question. Quick one on CD38 SADA. Do you think that the cadence of data disclosures will follow a similar pathway that GD2 SADA had like what we get in initial imaging data drop followed by a complete Phase 1a set? Thanks.

Speaker 2

No. Well, thank you for the question on that. I think as we look at this, there may be some data that we release early, just to show kind of where we are. But at the end of the day, I think it's more meaningful to look at a significant number of patients, collect that data and come back with a learning. As far as the timing of the cadence, the hope is now that we've had GD2 in patients in our 1,000 1 study that 1201 will recruit a little bit more quickly.

Speaker 2

And we could potentially get some of this use the learnings from our 1,001 to expedite our 1201. But that being said, my goal would be to put as much meaningful data together and look at it all in one consistent data release. Okay. Thanks. Appreciate it.

Operator

And our next question comes from David Nieregaarten from Wedbush Securities. Please go ahead, David.

Speaker 3

Hey, thanks for taking the question. I have one on SADA and that is, do you have any patients yet in that have entered into the Part C and kind of where are you on dosing dose escalation for the 1,001 study? Thanks.

Speaker 2

Yes. Thank you, David. We're still in Part A, and we have not moved to Part B yet. So where we are, we've done the first 14 patients. We dose escalated up to 3 milligrams per kilogram and we'll be moving on to our fiscal cohort shortly.

Speaker 2

However, until we complete Part A, the goal in Part A is to eliminate the 2 variables of protein load and the dose time to the radioisotope. Once those two variables are narrowed down, then we'll move into Part A where we escalate the activity in the isotope and then move to Part C, which is repeat up to 5 cycles.

Speaker 3

Maybe a quick follow-up if I could on the SADA protein dose escalation. Do you expect the targeting SADA molecules to have different dosing levels depending on the tumor type in the future? Or do you think you'll kind of be able to saturate the target and then figure out the appropriate radiation dose?

Speaker 2

Yes. I think that's part of our learnings moving forward. And so I want the data to take us to the right conclusion. So at this point, we're really trying to determine what the optimal protein load is. And once we determine that, there may be variations from SOTA molecule to SOTA molecule.

Speaker 2

There may be some variations patient to patient. But at the end of the day, we want to make this as simple for healthcare practitioners as possible to give both the practitioner and the patient to let the data dictate where we go and what that looks like for to let the data dictate where we go and what that looks like from both a protein load and a dosimetry perspective. Got it. Thanks. Thanks, David.

Operator

And our next question comes from Mike Ulz from Morgan Stanley. Please go ahead, Mike.

Speaker 7

Hi, good morning. This is Rowan on for Mike. Thanks for taking our questions. Just on the Daniel's, the trends for the remainder of the year, are you expecting consistency from quarter to quarter? Or do you expect to see more volatility?

Speaker 7

Thanks.

Speaker 4

Thanks Mike. Thank you, Ron. Robin.

Speaker 5

I got you.

Speaker 4

I'm sorry. Yes, I think in terms of quarter to quarter, there is some seasonality. But again, we reiterate that overall, we anticipate there will be a strong attainment of the global I'm sorry, the forecast number for this year. So the consistent trend is there. And with the new programs in place, we're starting to see those kick in.

Speaker 4

So I think that we'll have a steady growth, perhaps some seasonality in the summer, which we've seen every year since launch.

Speaker 2

Thank you. Thank you, Rob.

Operator

And at this time, there are no further questions. Would like to turn the call back over to Michael Rossi for closing remarks.

Speaker 2

Well, thank you all for joining us today to discuss the progress made during the Q1 of this year. With strong financial foundation from Danielle's commercial success and our responsible capital allocation strategy, We're uniquely positioned to continue top line growth while advancing the clinical development of our differentiated radio immune therapy platform, sotaprit, and potentially deliver better and safer therapeutic options in the treatment of a variety of cancers. We look forward to seeing many of you at upcoming investor and medical meetings, in particular, ASCO and SNMMI. Thank you and have a great day.

Operator

This concludes today's conference call. Thank you for attending.

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