Q1 2024 Y-mAbs Therapeutics Inc Earnings Call

Participants

Courtney Dugan; VP & Head of IR; Y-mAbs Therapeutics Inc

Michael Rossi; President, Chief Executive Officer, Director; Y-mAbs Therapeutics Inc

Susan Smith; Senior Vice President, Chief Commercial Officer; Y-mAbs Therapeutics Inc

Vignesh Rajah; Senior Vice President, Chief Medical Officer; Y-mAbs Therapeutics Inc

Bo Kruse; Chief Financial Officer, Executive Vice President, Treasurer, Secretary; Y-mAbs Therapeutics Inc

Alec Stranahan; Analyst; BofA Securities

Bill Maughan; Analyst; Canaccord Genuity

Etzer Darout; Analyst; BMO Capital Markets

David Nierengarten; Analyst; Wedbush Securities Inc

Mike Ulz; Analyst; Morgan Stanley & Co. LLC

Presentation

Operator

Good morning, and welcome to Y-mAbs Therapeutics Inc. earnings conference call for the first quarter of 2024. (Operator Instructions) As reminder, today's conference will be recorded, and I will now hand it over to Y-mAbs' Head of IR, Courtney Dugan.

Courtney Dugan

Thank you, operator, and good morning, everyone. Welcome to the Y-mAbs First Quarter 2024 financial results conference call. We issued a press release this morning and yesterday excuse me, 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.
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 and other development programs, potential for DANYELZA of territory and label expansion and potential of an advancement of data collaborations or strategic partnerships and the potential benefits thereof, expectations related to our anticipated cash runway and cash burn and 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 31st, 2024, as filed with the SEC on May seventh, 2024.
I would now like to turn the call over to our President and Chief Executive Officer, Mike Rossi.

Michael Rossi

Good morning, and thank you for joining us I have with me today our Chief Financial Officer, Bo Kruse; our Chief Commercial Officer, Sue Smith; and our Chief Medical Officer, Dr. Vignesh Rajah. Thomas Gad, our Founder and Chief Business Officer, will join us for the Q&A portion of this call following our prepared remarks this morning, I will start off by reviewing key financial and operational highlights from the first quarter of 2024, including DANYELZA sales performance in the clinical progress of our radiotherapy clinical programs, utilizing our self assembly disassembly pre targeted radio immune therapy for Satya create technology platform.
Next, Sue will provide details around our global DANYELZA sales in the first quarter. Vignesh will then provide updates around our ongoing naxitamab ISS. clinical trials. Bo will then provide an overview of our first quarter of 2024 financial performance, our cash resources, and reiterate our full 2024 guidance before we open the line for Q&A.
Let's begin with key highlights for the first quarter of 2024, starting with DANYELZA serve. As a reminder, DANYELZA 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 third, most common cancer in children. In the first quarter of 2024, we achieved record U.S. net sales product sales of DANYELZA Costa of $18.6 million, up 11% from what we recorded in the first quarter of 2023, we achieved record demand vials sold of DANYELZA by further penetrating the top high volume centers across the U.S. We expect this positive momentum to continue throughout the year.
From a worldwide standpoint, we achieved global DANYELZA net product sales of $19.4 million in the first quarter 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 first quarter of 2024 compared to the prior year. As expected, our first quarter 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.S. markets, we have 63 sites activated across the U.S. to date with five new accounts added in the first quarter of this year. Our U.S. commercial team has been doing a fantastic job of continuing to penetrate high volume centers and increasing physician adoption of DANYELZA.
In addition to the U.S., our ex U.S. footprint continues to expand through multiple partnerships. DANYELZA is approved and has been launched in China through our partner cyclone. It has been recently launched by our partner, ADM 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 or refractory neuroblastoma in Europe. In addition, we plan to submit a BLA for DANYELZA in Argentina this year and could potentially receive an additional approval in Asia in 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 readout from its multi-center Phase two trial investigating naxitamab in patients with relapsed or relapsed osteosarcoma. As we anticipate in the fourth quarter of this year, you will hear more about the progress of the ongoing investigator-sponsored trials of naxitamab from the NASH later during this call.
Now let me shift to the clinical progress of our cytokine program. Phase one GD. two, Sara. Our first data clinical program is our GD. two data, which is in Phase one 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 one dose escalation single arm. Multi-center safety study has three parts, which you can see here Part A. explores dose-finding for GD. two side of molecule and the testing of dose intervals of two to five days between the proteins and the lutetium data payload. Part B determines the optimal dose of lutetium data in 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 trials progressing. We have advanced through cohorts one, two and three and are now dosing patients in Cohort four, we have dosed a total of 14 patients to date. In this trial, we currently have seven sites open and plan to continue adding additional sites. Recall the parties of the trials investigating the safety profile of the protein and determining the optimal timing to administer. The radionuclide 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 GD. two Santa can both find and bind to tumors. It is important to note that these early data is not complete and are not necessarily indicative of the full results are the ultimate success of the trials for the side of development program, we expect to complete Cohort five of Part A. component of Phase one study by the end of this year and look forward to present the full data set from Part A. at a medical meeting in late 24 for 2025.
Our second separate program is a CD 38 data, 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 first data program is circulating tumors. Our planned Phase one follows a comparable design to our GD. two data Phase one trial which you can see here, we're on track to activate the first two sites in the second quarter of this year and expect recruitment of patients to follow the closing of the contracts. We are incredibly excited by the opportunity of our data prep platform to potentially shift the treatment paradigm across a variety of cancers and potentially even indications beyond oncology, we look forward to providing further updates on our data prep programs and clinical progress throughout the year, including at the Asco Annual Meeting in the Society of Nuclear Medicine and Molecular Imaging or SNMMI. annual meetings, which both occur in June.
Shifting gears a bit, I want to take a moment to acknowledge brokers. As you likely saw in March, we announced both resignation as CFO of Y-mAbs BOA 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 Y-mAbs is in a strong financial and operational position as soon transitions out of the role and supports us in search of a new CFO.
I want to thank Paul for his dedication to Y-mAbs and a strategic partnership. We wish him all the best as he embarks on his next career journey.
Additionally, in March of this year, we entered into a separation agreement with our Chief Scientific Officer stimulus be the separation agreement did not result in material impact to our financial statements. We wish Dr. will speak Good luck with future endeavors.
Our search for new chief scientific officer is ongoing with a focus on the continued advancement of our novel radiopharmaceutical platform. I'm incredibly confident in our entire team as we currently have in place here at Y-mAbs, 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 DANYELZA sales for the first quarter of 2024.

Susan Smith

Thank you, Mike, and good morning, everyone. I'm really pleased with the commercial progress of DANYELZA 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 first quarter.
Let me begin with our commercial progress in the U.S. during the fourth quarter last year, we rolled out a new DANYELZA campaign in the U.S. aimed to reposition and elaborate on DANYELZA as 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 DANYELZA US performance in two different patient populations, those patients with an incomplete response response to induction therapy and patients who are relapsed after prior therapy. The new campaign also demonstrates DANYELZA or responses in children rechallenged with DANYELZA after prior GD2 therapy. We continue to expect to see meaningful traction from the new campaign over the coming quarters. Our first quarter 2020 for U.S. DANYELZA and net product revenues increased 11% year over year to $18.6 million for US accounts for more than 80% of DANYELZA of sales in first quarter of 2024 marked a record high in terms of US. DANYELZA demand and vials sold in the U.S., we achieved sales well above the first quarter portion of our internal forecast with the highest ever number of vials sold in a quarter since initial launch launch back in 2011, 2021, sorry, in the first quarter of 2024. U.s. sales measured in vials were 9% higher than the fourth quarter of 2023 and March 2024 was the highest month of vials sales in the U.S. ever. Bill will provide further color later during the call.
Further, the team is focused on multiple U.S. key activities, driving performance in the first quarter and beyond. In the first quarter of 2020 for the marketing team launched an accompanying enhanced digital campaign. The field sales team is hard at work, educating customers on the new data contributing to DANYELZA U.S. Continued growth outside of MSK was 16% growth in the first quarter of this year versus fourth quarter of 2023. Our commercial team also engaged with our key customers with active presence at meetings such as FOA. fund and tandem transplant meeting. During the first quarter, a total of 63 accounts have now used annuals around the U.S. Since its initial launch in 2021, with five new accounts added in the first quarter of 2024, February 2024 marked the highest number of active sites. And I'm sorry of Playa, my computer just stopped is 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 XMSK. sales compared to 55% of sales ex MSK in the fourth quarter of 2023. In fact, our XMSK. sales were the best ever in the month of March 2024. Physician utilization of DANYELZA also continues to grow 18 health care practitioners started a patient on DANYELZA. And in the first quarter of 2024, since launch, a total of 106 HCPs have prescribed DANYELZA and 31 HCPs have started treatment on two or more patients as of March 31st, 2024. Our U.S. commercial sales team continues to receive positive HCP. feedback on DANYELZA through ongoing customer interactions. In addition, we continue to see institutional adoption of DANYELZA offer, which was added to three hospital formularies in the fourth first quarter of 2024, bringing the total cents. launch to 44 hospital formularies as of March 31st, 2024. We continue to see an upward trend of sales growth in the US since initial launch as DANYELZA also positively impacts patient lives and 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. Our first quarter of 2020 for total DANYELZA and net product revenues decreased 4% to $19.4 million versus the first quarter of 2023, primarily driven by timing in international purchases. Despite this 4% decrease, total product revenues came in above our internal forecast. This positive start, that's a promising tone for upcoming quarters as our team remained steadfastly focused on further market penetration to bring DANYELZA to more pediatric high-risk neuroblastoma patients we continue to receive positive feedback and physician uptake of DANYELZA in China through our partner cyclone. During the first quarter of this year, our South American partner, ADM came to an agreement with the drug market regulation chamber or CMS on the price of DANYELZA in 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 DANYELZA net product sales guidance for the full year of 2024 of between $95 million and $100 million.
Let me now pass the call to Vignesh.

Vignesh Rajah

Thank you, Sue, and 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 DANYELZA or through our investigator-sponsored clinical studies in collaboration with leading KOLs in the front-line high-risk neuroblastoma setting our partner would be Childhood Cancer Research Consortium or BCC. It's conducting a multicenter Phase two trial evaluating naxitamab in combination with standard induction therapy for patients with newly diagnosed high-risk neuroblastoma, 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 two 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 the randomized trial is to demonstrate superiority in complete response at the end of induction therapy in an extra demand bump versus standard of care. Bcc expects to potentially initiate a new randomized study in the second quarter of this year. In osteosarcoma, we are working with Memorial Sloan Kettering Cancer Center on its multicenter investigator-sponsored trial for naxitamab. We continue to expect MSK to provide a data readout from this Phase one two trial in the fourth quarter of this year. And based on the outcome of this, we will evaluate plans for our pivotal randomized trial are anticipated to be initiated in the second in breast cancer. We are partnering with the Ohio State University on a Phase Ib two trial investigating TGF beta NK cells, gemcitabine plus naxitamab in patients with GD. two positive metastatic breast cancer. The first patient is expected to be dosed to DANYELZA in the second quarter of this year upon the outcome of this trial, we will consider moving forward with a multicenter Phase two trial. In addition, we have partnered with the Institute of mother and child in Poland on a randomized Phase two trial evaluating the efficacy and safety of naxitamab in patients with refractory Ewing sarcoma, which was initiated during the fourth quarter of 2023. Recruitment is ongoing and three patients have been dosed in an extra month 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 GD2 space in both pediatric and adult cancers. 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, and we look forward to updating you on our progress at escalated this month and in the coming quarters.
Let me now hand the call over to Bo Kruse.

Bo Kruse

Thank you, Vic, Nish, and good morning, everyone. As you heard from Mike and Sue U.S., revenues increased 11% $18.6 million in the first quarter compared to $16.8 million in the same quarter of 2023, while international revenues decreased by $2.8 million in the first quarter compared to $3.4 million in the first quarter of 2023. The decline in international revenues was driven by our distribution partner with clinical, which generated revenues in the first quarter of 2023 of $2.5 million due to an initial inventory stocking order compared to no revenues in the first quarter of 2024. Our global tenures and net product revenues of $19.4 million in the first quarter 2023 represented a 4% decrease compared to the same quarter of 2023 U.S. DANYELZA net product revenues increased 3% compared to the quarter ended December 31st, 2023, when excluding $0.3 million and $1.3 million impact from Medicaid accrual change in estimate recognized as increases in net product revenues in the quarters ended March 31st, 2024 and December 31st, 2023, respectively. The Nielsen net product revenues of $19.4 million in the first quarter of 2024 represented a 17% decrease compared to the fourth quarter of 2023 and was primarily driven by decreased international revenues. We reported $500,000 worth of license revenues in the three months ended March 31st, 2024, and did not have license revenue for the three months ended March 31st, 2023.
Moving to operating expenses, our research and development expenses decreased slightly by $0.1 million to $13.3 million for the three months ended March 31st, 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 31st, 2023, partially offset by $2.5 million increase in clinical trial costs due to our investments in our site approved programs in 2024.
Selling, general and administrative expenses decreased by $0.8 million to $11.4 million for the three months ended March 31st, 2024 compared to the same periods in 2023. The decrease in SG&A for the quarter ended March 31st, 24 was primarily attributable to decreased personnel costs related to this restructuring charge recorded in the quarter ended March 31st, 2023.
We reported a net loss for the quarter ended March 31st, 2024 of $6.6 million, or $0.15 per share basic and diluted, compared to a net loss of $6.4 million or $0.15 per share basic and diluted for the quarter ended March 31st, 2023. As mentioned earlier, we ended the first quarter with cash and cash equivalents of $75.7 million compared to $78.6 million at year-end 2023. The decrease was $2.9 million for the quarter. Importantly, we reduced our quarter cash used from $13.1 million to $2.9 million or by about 78% year over year in 2024 compared to 2023.
Turning now to our guidance, we are reiterating our full year 2024 guidance. We continue to expect full year 2020 for total DANYELZA net product revenues to be in the range of $95 million to $100 million. We anticipate operating expenses to be in the range of $115 million to $120 million, and we expect a cash burn for the full year 2024 of between $15 million and $20 million. 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 that unused net product revenues are assumed to increase by 10% each year from 2024 through 2027. We hope to see a higher growth rate for 10 years 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, I assumed at this point for the purpose of this analysis with a strong balance sheet and focused strategy, we believe Y-mAbs is well positioned to execute on our strategic mission and priorities and to support the delivery of multiple anticipated milestones ahead.
Now this concludes my financial update, and I'll now turn the call back to Mike.

Michael Rossi

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

Question and Answer Session

Operator

(Operator Instructions) Alec Stranahan, Bank of America.

Alec Stranahan

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 tenure of the growth coming from? Is it from activating new centers or is it from repeat use from physicians who have already treated patients previously with DANYELZA? And how are you maybe positioning your new marketing efforts to drive this And then I've got a follow-up.

Susan Smith

Good morning, Alex, thanks for the question. And the marketing mix for us is a combination 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've heard, we've been added to several three new formularies in the first quarter, which we're pulling through. So we're very excited about that. And the new campaign is also opening up some greater education around that part D 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 on existing and new accounts. And I think I'm sorry, what was the second part of your question?

Alec Stranahan

I think you answered is how you're positioning the new marketing efforts yes, yes.

Susan Smith

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

Alec Stranahan

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

Michael Rossi

And Alec, thank you. And I as we look at it radioactive material and what we do from both the diagnostic and the therapeutic. There's opportunities to look at multiple receptor modulator diseases where we started and theranostics 80 years ago was in endocrinology and treating hyperthyroidism. So before it went on to thyroid cancer. So as we looked at this many receptor modulator diseases where you need to either decrease or receptor response time or to just decrease the overall production of snow hormones, things like that, you have the opportunity to treat with radioactive materials and treat in a very safe and effective way so I wouldn't limit us to just Oncology's and as we look at the opportunities that lie ahead for these products.

Alec Stranahan

Thank you.

Michael Rossi

But thank you, Alec.

Operator

Bill Maughan, Canaccord Genuity.

Bill Maughan

Bill, thanks for taking the question and good morning. I just wanted to take a quick look at ex U.S. DANYELZA and understanding that bulk ordering and timing of those orders can affect revenue numbers. Do you have visibility into vial sales on the underlying demand? And then just kind of going forward, do you expect and we appreciate that DANYELZA is being broken out U.S. versus ex USNG., do you expect US 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?

Michael Rossi

No Bill, Bill, thank you for that. And I would like to 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 from now, there will be additional growth as we move into these launch markets. And we have some real opportunity to continue to growth. As you look at this, we're in the 80 20 range today with U.S. and ex U.S. with U.S. being the driver. U.s. will continue to be in the driver's seat. And it's because as we continue to grow the US, we'll continue to grow the ex U.S. market. But as a direct market, it contributes more to the overall top and bottom lines. And compared to ex U.S., I think that 80 20 mix is something that you'll see without the massive spread moving forward. But we may we may see some additional contribution from the ex U.S. market beyond the US as the US does tend to mature over a period of time.

Susan Smith

And so if there's anything that you'd like to add and 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 their launches in the case of ADM and their ongoing sales.
In the case of Cyclone and other. So and our Company is well aligned to their stakeholders of our partner companies and have an ongoing dialogue in terms of the details behind the numbers.
So and I and I agree with what Mike said in terms of the breakout of 80 20. And I think everyone knows the U.S. is the biggest market in terms of top and bottom line contribution, which probably will not change moving forward.

Bill Maughan

And then for just in the US, obviously, DANYELZA, the more important drug to Y-mAbs than Unituxin is to United Therapeutics. So as you continue to grow market share and more and more doctors start to write, DANYELZA, do you are you sensing sort of a high 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 being tolerated and you can continue to grow and along the plans that you're implementing?

Susan Smith

Well, I think our growth speaks for itself and we do not hear a minor thing. They do not have a sales force. And so I think our share of voice is the greatest. And from market research, we are recognized as the number one company in India and our commitment to pediatric neuroblastoma among treaters. So we continue to come to build those relationships with the key accounts. And we're not hearing a lot of noise from US WorldMeds.

Bill Maughan

Great. Thanks.

Operator

Etzer Darout, BMO Capital Markets.

Etzer Darout

As far behind as we look out for us. So thanks for taking my question. A quick one on CD38. Santa Ana, do you think that the cadence of data disclosures will follow a similar pathway that G. two sort of had like will we get an initial imaging data drop followed by a complete Phase Ia set? Thanks.

Michael Rossi

Thank you for the question on that. I think as we look at this, you know that there may be some data that we released earlier. Tom, 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 the learning. As far as the timing of the cadence, the hope is now that we've had GD. two in patients in our 1001 study. That 12 I want to recruit a little bit more quickly and we could potentially get some of this used the learnings from our 1001 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 one, consistent data points.

Etzer Darout

Thanks, appreciate it.

Operator

David Nierengarten, Wedbush Securities.

David Nierengarten

David, thanks for taking my question and one on Sarta, and that is do you have any patients yet and that have entered into the Part C and kind of where where are you on on dose dosing dose escalations for the one oh one oh one study mix?

Michael Rossi

Yes. Thank you, David. That we're still in Part A., and we have now moved to Part B at. And so where we are, we've done the first 14 patients, we dose escalated up to three milligrams per kilogram, and we'll be moving on to our fifth cohort shortly. However, until we complete Part A., the goal in Part A. is to eliminate the two variables of protein load and the dose timing to the radio isotope. 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 five cycles or maybe I have a quick follow-up, if I could.

David Nierengarten

If you saw the protein dose, the dose escalation. Do you expect on the site targeting targeting saw the molecules to have different you have dosing levels on the up 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?

Michael Rossi

Yes, I do that. That's part of our learnings moving forward. 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 sought a molecule, a subtle molecule. There may be some variations patient to patient. But at the end of the day, we want to make this as simple for health care practitioners as possible to give both the practitioner and the patient, the best opportunity for an effective therapy. So we're taking and all of the data that we can, we'll collect that and then take a qualified step backwards to let the data dictate where we go and what that looks like from both a protein loading and dosimetry perspective, et cetera, thanks.

Operator

Mike Ulz, Morgan Stanley.

Mike Ulz

Hi, good morning. This is Robert on for Mike. Thanks for taking our questions on just the and then yields. So trends for the remainder of the year? Are you expecting consistency from quarter to quarter or do you expect to see more volatility? Thanks.

Susan Smith

Thanks for joining us here. On gross to net. And 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 on attainment of the net of the global I'm sorry, the own 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. So I think that will have a steady growth, perhaps some seasonality in the summer, which we've seen every year since launch figures.

Mike Ulz

Thanks.

Operator

At this time, there are no further questions. I would like to turn the call back over Michael Rafay for closing remarks.

Michael Rossi

So thank you all for joining us today to discuss the progress made during the first quarter of this year with strong financial foundation from DANYELZA commercial success, 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 side of prep 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.