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Operator
Good morning and welcome to YMAB's Therapeutic, Inc. earnings conference call for the first quarter 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. I will now hand it over to YMAB's head of IR, Courtney Dugan.
Courtney Dugan
Thank you, Operator, and good morning, everyone. Welcome to the YMAS First Quarter 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. 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 Danielle'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 31st, 2024, as filed with the SEC on May 7th, 2024. I would now like to turn the call over to our President and Chief Executive Officer, Mike Rossi.
Mike Rossi
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, Dr. Vanessa Rojas. Thomas Gadd, 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 Danielle's sales performance and the clinical progress of our radiotherapy clinical programs utilizing our self-assembly, disassembly, pre-targeted radioimmune therapy, or SADA PRIT technology platform. Next, Sue will provide details around our global Danielsa sales in the first quarter. Vinesh will then provide updates around our ongoing Nexidimab 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 Danielsa. As a reminder, Danielsa 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 product sales of Danielsa, of 18.6 million, up 11% from what we recorded in the first quarter of 2023. We achieved record demand and vials sold of Danielsa 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 Danielsa 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 Danielza. In addition to the U.S., our ex-U.S. footprint continues to expand through multiple partnerships. Danielza is approved and has been launched in China through our partner, Cyclone, and 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 and refractory neuroblastoma in Europe. In addition, we plan to submit a BLA for Danielza 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 Nexidimab trials in support of our indication expansion strategy. In particular, we look forward to Memorial Sloan Kettering's readout from its multicenter phase two trial investigating Nexidimab in patients with relapsed osteosarcoma as we
Danielsa
from Binesh later during this call.
Mike Rossi
Now let me shift to the clinical progress of our SADA PRIT programs. Phase 1 GD2 SADA. Our first SADA PRIT 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 one dose escalation single arm multicenter safety study has three parts, which you can see here. Part A explores dose finding for GD2 SADA molecule and the testing of dose intervals of two to five days between the protein and the lutetium DOTA payload. 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 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 that Part A is 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 SPECT CT scans and PK activity we have seen to date, we believe we have demonstrated proof of concept that GD2-SATA can both find and bind to tumors. 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 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 or 2025. Our second SADA-PRIP 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 first SADA program in circulating tumors. Our planned phase one follows a comparable design to our GD2 SADA 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 SADA-PRIP 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 SADA-PRIP 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 Bo Cruz. As you likely saw in March, we announced Bo's resignation as CFO of YMABS. Bo 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 Bo for his dedication to YMABS and his 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, Steve Lisby. The separation agreement did not result in material impact to our financial statements. We wish Dr. 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. I'm incredibly confident in our entire team as we currently have in place here at YMABS, 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 Danielsa sales for the first quarter of 2024.
Sue Smith
Thank you, Mike, and good morning, everyone. I'm really pleased with the commercial progress of Danielsa on a 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 of last year, we rolled out a new Danielza campaign in the U.S. aimed to reposition and elaborate on Danielza'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 Danielza's performance in two 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 Danielza responses in children re-challenged with Danielza after prior GD2 therapy. We continue to expect to see meaningful traction from the new campaign over the coming quarters. Our first quarter, 2024, U.S. Danielsa net product revenues increased 11% year-over-year to $18.6 million. The U.S. accounts for more than 80% of Danielsa sales. And first quarter of 2024 marked a record high in terms of U.S. Danielsa 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 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 vial sales in the U.S. ever. Bo 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 2024, 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 Daniels' continued growth outside of MSK with 16% growth in the first quarter of this year versus fourth quarter 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 first quarter. A total of 63 accounts have now used Danielle's around the U.S. since its initial launch in 2021, with five new accounts added in the first quarter of 2024.
Tandem Transplant
February 2024 marked the highest number of active sites in, I'm sorry,
Sue Smith
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 fourth quarter of 2023. In fact, our ex-MSK sales were the best ever in the month of March 2024. Physician utilization of Danielza also continues to grow. Eighteen healthcare practitioners started a patient on Danielza in the first quarter of 2024. Since launch, a total of 106 HCPs have prescribed Danielza, 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 Danielza through ongoing customer interactions. In addition, we continue to see institutional adoption of Danielza, which was added to three hospital formularies in the first quarter 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. 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. Our first quarter of 2024 total Danielza 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 sets a promising tone for upcoming quarters as our team remains steadfastly focused on further market penetration to bring Danielza to more pediatric high-risk neuroblastoma patients. We continue to receive positive feedback in physician uptake of Danielza in China through our partner, Cyclone. During the first quarter of this year, Our South American partner, Adium, came to an agreement with the Drug Market Regulation Chamber, or CMED, on the price of Daniels 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 Daniels in 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
Thank you, Sue. Hello, everyone. I'm pleased to provide a brief update on our ongoing Nexidimab clinical trials. We continue to advance potential label expansion opportunities for Danielzo 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 multi-center phase two trial evaluating Nexidimab in combination with standard induction therapy for patients with newly diagnosed high-risk neuroblastoma. 16 sites have been opened and recruitment is ongoing. The trial is expected to transition from a single-arm study with Nexidimab 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 IMD. Our aim for that randomized trial is to demonstrate superiority in complete response at the end of induction therapy in the Nexidimab arm versus standard of care. The 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 Nexidimab. We continue to expect MSK to provide a data readout from this Phase 1-2 trial in the fourth quarter 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 1B-2 trial investigating TGF-beta NK cells, gemcitabine, plus Nexidimab, in patients with GD2 positive metastatic breast cancer. The first patient is expected to be dosed with Danielle's 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 Naxidimab in patients with refractory Ewing sarcoma. which is initiated during the fourth quarter of 2023. Recruitment is ongoing and three patients have been dosed in the Nexidimab 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 antigenic 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 Nexidimab. We look forward to updating you on our progress at ASCA later this month and in the coming quarters. Let me now hand the call over to Bo Cruz.
Naxidimab
Thank you, Vignesh, and good morning, everyone. As you heard from Mike and Sue, U.S. revenues increased 11% to 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 Danielsa net product revenues of $19.4 million in the first quarter of 2023 represented a 4% decrease compared to the same quarter of 2023. U.S. Danielsa net product revenues increased 3% compared to the quarter ended December 31st, 2023, when excluding the $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 Danielson 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 the decreased international revenues. We reported $500,000 worth of licensed revenues in the three months ended March 31st, 2024 and did not have licensed 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 a $2.5 million increase in clinical trial costs due to our investments in our Cytoprid programs in 2024. Selling, general, and administrative expenses decreased by $0.8 million to $11.4 million for the three months ended March 31, 2024, compared to the same period in 2023. The decrease in SG&A for the quarter ended March 31st, 24, was primarily attributable to decreased personal 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 15 cents per share, basic and diluted, compared to a net loss of 6.4 million or 15 cents Per share, basic and diluted for the quarter ended March 31, 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 use 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 2024 total Danielsa net product revenues to be in the range of 95 to 100 million. We anticipate operating expenses to be in the range of 115 to 120 million and we expect a cash burn for the full year 2024 of between 15 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, The Danielsa net product revenues are assumed to increase by 10% each year from 2024 through 2027. We hope to see a higher growth rate for Danielsa 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 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.
Danielsa
Thank you for that overview, Bo.
Mike Rossi
Now, let's open the line for questions. Operator?
Operator
At this time, we will conduct the question and answer session. If you would like to ask a question, please press star 1 on your telephone keypad now, and you'll be placed into the queue in the order received. Please be prepared to ask your question when prompted. Once again, if you would like to ask a question, please press star 1 on your phone now. And our first question comes from Alex Stranahan from Bank of America. Please go ahead, Alex.
Alex
Hey, guys. Thanks for taking our questions. Just a couple from me. Maybe first for Sue, where do you see most of the current, in your 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 Danielza? And how are you maybe positioning your new marketing efforts to drive this? And then I've got to follow up.
Sue Smith
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 three new formularies in the first quarter, which we're pulling through. So we're very excited about that. The new campaign is also opening up greater education around 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, sorry, what was the second part of your question?
Alex
I think you answered it, just how you're positioning the new marketing efforts.
Sue Smith
Yes, yes. Again, it's demonstrating our value in two 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.
Alex
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 previous work. Thanks.
Mike Rossi
Alec, thank you. You know, 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. You know, where we started in theranostics 80 years ago was in endocrinology and treating hyperthyroidism. So, you know, 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, you know, hormones, things like that, you have the opportunity to treat with radioactive materials and treat in a very safe and effective way. So, you know, I wouldn't limit us to just oncology. And as we look at the opportunities that lie ahead for these products.
Danielsa
Great. Thank you. Thank you, Alex.
Operator
And our next question comes from Bill Mahan from Canaccord Genuity. Please go ahead, Bill.
Bill Mahan
Hi, thanks for taking the question. Good morning. I just wanted to take a quick look at ex-U.S. Danielza. 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 Danielza is being broken out U.S. versus ex-U.S. now. Do you expect U.S. to remain – clearly the main driver going forward or, or, or will the rest of the world at some point, um, you know, take, take some more share of the growth story here.
Mike Rossi
You know, Bill, Bill, thank you for that. And, um, 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 XUS. So we're very confident in our forecasting and where we are, um, Now there will be additional growth as we move into these launch markets and have some real opportunity to continue the growth. I think 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 because as we continue to grow the U.S., 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 as we compared to ex-U.S. So I think that 80-20 mix is something that you'll see without massive spread moving forward. But we may see some additional contribution from the ex-U.S. market beyond the U.S. 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.
Sue Smith
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 others. So our company is well aligned to their stakeholders at our partner companies and have an ongoing dialogue in terms of the details behind the numbers. And I agree with what Mike said in terms of the breakout of the 80-20. 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.
Danielsa
Okay. And then...
Bill Mahan
In the U.S., obviously, Danielza is a more important drug to YMAB than Unitoxin is to Unite Therapeutics. So as you continue to grow market share and more doctors start to write Danielza, 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, you know, along the plans that you're implementing?
Tandem Transplant
Well, I think, you know, our growth speaks for itself.
Sue Smith
And we do not hear, to my understanding, they do not have a sales force. So, you know, I think our share of voice is the greatest. And from market research, we are recognized as the number one company in our commitment to pediatric neuroblastoma among treaters. So we continue to build those relationships with the key accounts, and we're not hearing a lot of noise from U.S. World Meds.
Danielsa
Great. Thank you.
Tandem Transplant
Mm-hmm.
Operator
And our next question comes from Etzer Derout from PMO Capital Market. Please go ahead, Etzer.
Etzer Derout
Hi, this is Luke. Thanks for taking my question. Quick one on CD38-SATA. Do you think that the cadence of data disclosures will follow a similar pathway that GD2-SATA has? Like, will we get an initial imaging data drop followed by a complete phase 1A set? Thanks.
Mike Rossi
No. Well, thank you for the question on that. I think as we look at this, you know, 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 the learning. As far as the timing of the cadence, you know, the hope is now that we've had GD2 in patients in our 1001 study, that 1201 will recruit a little bit more quickly, and we could potentially get some of this, use the learnings from our 1001 to expedite our 1201. But that being said, you know, my goal would be to put as much meaningful data together and look at it all in one consistent data release. Okay, thanks.
Danielsa
I appreciate it.
Operator
And our next question comes from David Neergarten from Wedbush Securities. Please go ahead, David.
David Neergarten
Hey, thanks for taking that question. I have one on And that is, do you have any patients yet that have entered into the Part C? And, you know, kind of where are you on dosing dose escalation for the 1001 study? Thanks.
Mike Rossi
Yeah, thank you, David. No, 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 three milligrams per kilogram, and we'll be moving on to our fifth cohort shortly. However, you know, until we complete part A, you know, the goal in part A is to eliminate the two variables of protein load and the dose timing 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 five cycles.
David Neergarten
Maybe a quick follow-up, if I could, on the SADA protein dose escalation. Do you expect, you know, the targeting, you know, targeting SADA molecules to, you know, have different, you know, dosing levels, you know, depending on the tumor type in the future? Or do you think you'll kind of, you know, be able to saturate the target and then figure out the appropriate radiation dose?
Mike Rossi
Yeah, I think 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 cytomolecule to cytomolecule. 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. Give both the practitioner and the patient the best opportunity for an effective therapy. So we're taking in 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. Got it. Thanks.
Operator
And our next question comes from Mike Ull from Morgan Stanley. Please go ahead, Mike.
Mike Ull
Hi, good morning. This is Rowan on for Mike. Thanks for taking our questions. Just on the Danielle's trends for the remainder of the year, are you expecting consistency from quarter to quarter or do you expect to see more volatility? Thanks.
Tandem Transplant
Thanks, Mike. Thank you, Rowan.
Mike Ull
Go ahead, Sue.
Sue Smith
I'm sorry. Yeah, 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 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. I think that we'll have a steady growth, perhaps some seasonality in the summer, which we've seen every year since launch.
Danielsa
Thank you. Thank you, Roy.
Operator
And at this time, there are no further questions. I would like to turn the call back over to Michael Rossi for closing remarks.
Mike Rossi
Thank you all for joining us today to discuss the progress made during the first quarter 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 radioimmune 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 S&MMI. Thank you, and have a great day.
Operator
This concludes today's conference call. Thank you for attending.
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