Good morning and welcome to Y-mAbs Therapeutics Third Quarter 2023 Earnings Conference Call. Please note that today’s event is being recorded. At this time, all participants are in a listen-only mode. Instructions for the question-and-answer session will follow after the prepared remarks.

I would now like to turn the conference over to Courtney Dugan, Vice President Investor Relations. Please go ahead..

Thank you, operator. Good morning everyone. Welcome to our third quarter 2023 earnings conference call. We issued a press release with our results yesterday at market close. The press release and accompanying slides are available on the Investor Relations 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 of early trial results, current and future clinical and preclinical studies in 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 DANYELZA territory expansion and advancement of SADA, collaborations for strategic partnerships and the potential benefits thereof, expectations related to our anticipated cash runway and the sufficiency of our cash resources and assumptions related thereto, guidance and expectations for 2023 and beyond and our financial performance, including our estimates regarding revenues, expenses and capital expenditure requirements and other statements that are not historical facts.

Because forward-looking statements involve risks and uncertainties, they are not guarantees of future performance, and actual results may differ materially from those expressed or implied by these forward-looking statements due to a variety of factors, including those risk factors discussed in the company’s quarterly report on Form 10-Q for the quarter ended September 30, 2023 as filed with the SEC on October 13, 2023.

With that, I would now like to turn the call over to our Founder, Vice Chairman of the Board and Director and Chief Business Officer, Thomas Gad..

Thank you, Courtney. Good morning, everyone, and thank you for joining us today. Today I have with me our Chief Financial Officer, Bo Kruse; our Chief Commercial Officer, Sue Smith; and our Chief Scientific Officer, Dr. Steen Lisby. And also very excited to welcome newly appointed, Michael Rossi.

In today’s call, Mike will begin by reviewing third quarter global highlights on DANYELZA sales, updates on our ongoing naxitamab clinical trials and high level updates around our SADA program. Sue will then report further insights into our U.S. DANYELZA sales in the Q3.

Next, Dean will provide further details on our Phase 1 GD2-SADA trial currently underway in addition to updates on our CD38 SADA program for which we recently have received IND clearance by the USFDA.

Then Bo will provide an overview of our third quarter financial performance, our cash resources and our full-year 2023 guidance before we open the line for Q&A.

Before we get into the third quarter results, on behalf of the Y-mAb’s Board of Directors and our senior leadership team, I want to extend a very warm welcome to our new President and CEO, Michael Rossi, who officially started on November 6th.

Our Board has conducted a careful search for the right dedicated leader of our company with deep commercial and radiopharmaceutical experience, and we are very pleased to have found that in Mike. Michael brings over 30- years of experience in the radiopharmaceutical industry.

He joins us from Mirion Technologies, where he served as the President of the Medical Group. Prior to that, Mike was the Head of Radiolig and Imaging at Advanced Accelerator Applications, better known as AAA, in Novartis’ company. And before that he led the growth of Jubilant Radiopharm into a vertical-integrated radiopharmaceutical leader.

Early on his career, Mike spent over a decade at GE Healthcare and he is also a certified nuclear pharmacist.

As we continue our efforts to expand the geographic reach of DANYELZA and further our indication expansion initiatives to maximize the utility of this therapy, we are also incredibly excited about our novel two step pre-targeted radioimmunotherapy platform, better known as SADA, and its potential to unlock the value of radiopharmaceuticals in the cancer treatment paradigm.

After our re-org in the first quarter of this year, Y-mAbs has been positioned as one of the few independent commercial state biotech companies with sufficient financial resources to advance SADA through proof-of-concept.

Is it the right time for me to transition to a new role of Vice Chairman and Chief Business Officer? And I very much look forward to working closely with Mike and our Board and the entire Y-mAbs team on our continued mission to bring novel therapeutics to cancer patients. And with that, I’m very excited to turn the call over to Mike. Go ahead, Mike..

Thank you, Thomas, for that introduction. It is great to be joining you all today for our Y-mAbs third quarter earnings call. As Thomas mentioned, I have built a 30-plus year career in healthcare with a specific focus on radiopharmaceuticals.

Y-mAbs is a pioneer in pre-targeted radioimmunetherapy with its SADA technology platform, which is a key driver of my own personal excitement about joining Y-mAbs. SADA stands out as a highly differentiated, pre-targeted, two-step platform that is designed to enable precise radioisotope delivery.

I truly believe that SADA has the potential to shift the treatment paradigm in radiotherapy. In addition, we have the promising DANYELZA franchise, where we expect to have a growing stream of revenue with our commercial product [indiscernible] to independently support our clinical development work with SADA in a rapidly expanding radiopharma market.

With our Phase 1 GD2-SADA trial underway, in our Phase 1 CD38 SADA trial anticipated to initiate next year and several additional exciting targets currently in preclinical development, we believe we have a highly promising clinical pipeline ahead. Now, let’s dive into the key highlights for the quarter starting with DANYELZA.

As a reminder, DANYELZA is approved by the USFDA for the treatment of relapsed or refractory high-risk neuroblastoma in the bone or bone marrow of 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 third quarter of this year, we achieved $20 million in net product sales of DANYELZA, up 59% from what we recorded in the third quarter of 2022. We continue to make significant progress in our commercialization efforts for DANYELZA, and we are gaining momentum in the U.S. with a number of new accounts.

We now have 57 sites activated across the U.S. since DANYELZA’s launch, with nine new accounts so far in 2023. We continue to expand our global commercial footprint through partnerships and recently received regulatory approval of DANYELZA in Mexico, marking our second regulatory approval in Latin America with our partner, Adium.

In addition, or as discussed last quarter, our partner SciClone successfully announced launched DANYELZA in China in June of this year. In terms of the number of vials used, in the first full quarter since the commercial launch in China, usage in China has been approximately with 50% of the vials used in the U.S. during the quarter.

While it is still early, we look forward to seeing the sales progress and trends in the region over the coming months. We see China as a key region for DANYELZA, and we look forward to providing an update in the coming quarters. We continue to be very pleased with the WEP program in Europe, with 19 patients treated with DANYELZA through the end of Q3.

The continued geographic expansion of DANYELZA across these regions is an important step in our mission to enable broad, global access for DANYELZA for patients with high-risk relapsed refractory neuroblastoma.

We remain encouraged by the expansion of DANYELZA, accumulating global net sales of more than $61 million in the first nine-months of 2023, as we continue to gain further traction with physicians prescribing DANYELZA.

We remain confident in our ability to continue to expand our global commercial market footprint and meet our full-year 2023 DANYELZA net product revenue guidance of between $80 million and $85 million. Sue will provide further color on DANYELZA sales in the quarter shortly. Now, let me briefly comment on our ongoing naxitamab clinical trials.

We continue to make progress on our investigator sponsored clinical trials in collaboration with leading KOLs to efficiently advance potential label expansion opportunities for DANYELZA.

In the front line high risk neuroblastoma setting, we are partnering with the Beat Childhood Cancer Research Consortium or [BCSCAPE] a multi-center Phase II trial evaluating naxitamab in combination with standard induction therapy for patients with newly diagnosed, high-risk neuroblastoma.

To-date, nine sites have been initiated and six patients have been dosed.

The study is expected to transition from a single arm study with naxitamab added to the current standard treatment for induction to a randomized study where the control arm will be the current standard-of-care for induction therapy, which is chemotherapy plus or minus an ALK inhibitor for which we plan to file an IND.

As a reminder, the patient recruitment for the trial is projected over a span of five years with anticipated total trial sample size of approximately 282 patients. Our aim for the trial is to demonstrate a superiority in naxitamab arm versus standard-of-care. We expect to potentially initiate the new randomized study in the Q2 of next year.

In Tecnofarma, we are continuing to work with Memorial Sloan Kettering Cancer Center, or MSK, on its multi-center investigator sponsored trial for naxitamab. We anticipate MSK to provide a data readout from this Phase 1/2 trial in fourth quarter of 2024. And if positive, we hope to then begin our recruitment for a pivotal randomized Phase 3 trial.

In addition, we are pleased with the publication of the study of naxitamab based chemoimmunotherapy HITS trial in patients with chemo-resistant high risk neuroblastoma in the general cancers.

In this trial, patients who received HITS immediately after induction had a higher response rates, 47% versus 18% and superior estimated three year overall survival 85% versus 29%, compared with those who received the same combination regimen later in the course of treatment.

These results further supported the utilization of naxitamab early during the course of treatment for patients with chemo-resistant, high-risk neuroblastoma. We are continuing to work to unlock further value of naxitamab and truly believe in its potential to fill a much-needed treatment gaps in both pediatric and adult cancers for patients worldwide.

Now, moving on to SADA. Our novel product technology platform is a key driver of my own personal excitement about joining Y-mAbs. Throughout my extensive career in various radiopharma leadership roles, I have had the privilege to witness the development of numerous breakthrough technological platforms.

However, SADA, which is licensed by Y-mAbs from MSK and the Massachusetts Institute of Technology in 2020 stands out as a highly differentiated, pre-targeted, two-step platform that is designed to enable precise radioisotope delivery.

We truly believe that SADA has the potential to shift the radiotherapy treatment paradigm and potentially be impactful in the fight against a wide variety of cancers. Sue will provide further color on our specific platforms later in today’s call. But let me provide a high-level overview of where we currently are with our SADA pipeline.

Our first program, GD2-SADA, began Phase I development earlier this year. To-date, we have completed dosing cohorts 1 and 2 currently administering doses of cohort 3.

Despite the limited patient sample size to date, we are very pleased with the positive progress we have seen so far, and we have decided to share early PK and proof-of-concept for our SADA platform during this call.

Due to the progress we are seeing, we have elected to focus on a more mature Phase 1 data readout at a major medical meeting next year in lieu of an R&D Day event in December. Our second program CD38 SADA recently received IND clearance from the USFDA to enter clinical development.

We are particularly excited about the program given our team’s deep CD38 targeted drug development experience. We anticipate exploring potential partnership opportunities, as this program advances.

The Phase 1 dose escalation, open label, single-arm, multi-center trial evaluating the safety and tolerability of CD38 SADA in patients with relapsed or refractory non-Hodgkin’s lymphoma is anticipated to begin next year.

We believe there remains a significant unmet medical need for these patients of both B-cell and T-cell origin, and we look forward to providing further updates as our program advances. In addition, we are continuing to advance multiple preclinical SADA targets, and have made encouraging progress, especially on our HER2 in B7-H3 constructs.

As we look ahead to the rest of 2023 and beyond, we believe, we are well-positioned with $86.6 million in cash and cash equivalents as of the end of third quarter 2023, which now believe will extend our cash runway to support our business operations, as currently planned into 2027.

Of note, our use of cash was only $1.3 million in the third quarter of this year, a direct result of effective capital management strategy and action following our reorganization earlier this year.

We believe we have the right strategy in place to drive further DANYELZA’s sales growth, which serves as the financial foundation to propel our SADA technology through clinical development with our two lead programs.

We believe we are in a great position to bring forward additional novel therapeutics to cancer patients, who need them, while at the same time delivering long-term value to shareholders. I’m thrilled to be here at Y-mAbs during this exciting time and look forward to working with this entire team.

With that, let me now turn the call over to Sue Smith, who will discuss our U.S. DANYELZA sales in further detail.

Sue?.

Thank you, Mike, and good morning, everyone. I’m pleased to be with the commercial - to share the commercial progress of DANYELZA in the U.S. We increased DANYELZA’s sales 59% year-over-year compared to the Q3 of last year.

Despite the unevenness from a quarter-over-quarter standpoint, this is not surprising in rare disease indications, particularly considering the ultra rare indication of DANYELZA. We continue to see an upward trend of sales growth, since the initial launch back in 2021.

Our percent growth since launch is performing well above where Unituxin was at three year post launch, 45% versus 22% growth, and we believe we have room for continued growth. As Mike mentioned, we have recorded $61 million in DANYELZA’s sales in the first nine-months of 2023.

We expect to meet our full-year 2023 sales guidance of between $80 million and $85 million in DANYELZA sales. Let me review key highlights from DANYELZA’s U.S. sales in the third quarter. At the close of the third quarter of 2023, we had a total of 44 new patient starts year-to-date. This brings the total of new patient starts since launch to 158.

We continue to grow outside of MSK, with non-MSK vials sold representing 63% of all DANYELZA demand in the U.S. during the Q3. With 57 accounts now having used DANYELZA around the U.S., we have seen 22 accounts treat two or more patients in the first nine-months of this year.

We believe physicians are getting more comfortable using DANYELZA, with 36 healthcare providers having prescribed DANYELZA in the first nine-months of this year, including seven HCPs starting two or more patients in the first nine-months of this year.

Since launch, a total of 88 doctors have prescribed DANYELZA, and 28 of them have started treatment on two or more patients as of September 30, 2023. Our U.S.

commercial sales team has received increasingly positive HCP feedback on DANYELZA through over 2,500 customer interactions in the first nine-months of this year and over 6,400 interactions since our launch in 2021.

We also continue to see institutional adoption of DANYELZA, which has been added to 5 hospital formularies in the 1st 9 months of this year, bringing the total since launch to 41 hospital formularies. Y-mAbs remains a leader in the U. S. Anti GD2 market, a highly important area of pediatric cancer, and a rare disease market with a flat incidence rate.

Looking ahead to the Q4 of this year and beyond, we are intensifying our market efforts, and our commercial team is in the process of rolling out a brand new DANYELZA campaign, which has then added to five hospital formularies in the first nine-months of this year, bringing the total since launch to 41 hospitals formularies.

Y-mAbs remains a leader in the U.S. anti-GD2 market, a highly important area of pediatric cancer and a rare disease market with a flat incident rate. Looking ahead to the Q4 of this year and beyond, we are intensifying our market efforts, and our commercial team is in the process of rolling out a brand new DANYELZA campaign.

The new campaign repositions and elaborates on DANYELZA’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. Utilizing our pre-specified interim analysis data, which was consistent with our label.

The campaign enables us to share our data for refractory versus relapsed patients separately, providing more detailed data regarding DANYELZA performance in patients with an incomplete response to induction therapy, and also patients who are relapsed, which are two different patient groups.

In addition, it demonstrates DANYELZA response in children after prior anti GD2 therapy. I’m very proud of this team. They have been hard at work in the preparation and rollout of the new campaign in addition to achieving year over year sales growth. We believe we will begin to see meaningful traction from the new campaign starting next year.

Let me now pass the call to Steen who will discuss the latest progress of our SADA platform in further detail..

Thank you, Sue, and good morning everyone. I’m pleased to provide you with an update on our SADA programs, beginning with GD2 SADA. Our Phase 1 trial evaluated the safety and tolerability of GD2 SADA in the treatment of GD2 positive solid tumors including small cell lung cancer sarcomas and malignant melanoma got away in March of this year.

This Phase 1 dose escalation single arm multicenter safety study has three parts. Part A explores the dose finding of the SADA molecule itself and testing the dose intervals of two to five days between the protein administration and the lutetium do payload.

Part B will determine the optimal dose of Lutetium DOTATATE, and Part C evaluates the safety and initial signs of efficacy using repeat dosing. Dose escalation is based on two patients in a cohort one and two, followed by modified three plus three design.

And it is important to emphasize that in each cohort patient will be observed after dosing in a so-called six weeks dose - toxicity period of DLT period. Currently, we are still in Part A and the trial is progressing very well.

We have dosed five patients in the third quarter and at present we have six active sites with three sites expected to be activated during fourth quarter this year. We had advanced through the first two cohorts and are out dosing patients in court. We now have more patients receiving the 200 milligram per dose of lutetium do.

I would like to emphasize that we are still in per day, uh, of this trial, which is central to investigate the safety profile of the protein and to determine the optimal timing to administer the rating client. We are pleased with what we are seeing so far. No patient has experienced any dose limiting toxicities to date.

Furthermore, no patients have experienced any related severe adverse events or serious adverse events. And of note, we can dose our protein with no severe or serious pain signals detected.

Today, we also can announce that we believe to have demonstrated proof of concept for the GD2 SADA by demonstrating that the SADA molecules can find and bind to tumors and that the radionuclide target SADA is visualized on the spec CT scans performed.

It is important to note that these early data are not complete and are not necessarily indicative of the full results or ultimate success of the trials SADA development program. As seen on next slide, we are an opinion that the exposure of the blood - exposed on the patients look as expected.

The data include four patients in each of the two treatment groups. So eight patients in total. The patient dose with a 0.3 milligram per kilogram protein represent here in blue, and the patient dose with a one milligram per protein here represented here in purple, are comparable and supported dose intervals of two to five days as being used so far.

On next slide, we for the first time are sharing a spec CT scan demonstrating tumor uptake in one patient. This scan was conducted after an imaging dose of 30 millicurie only. We are very encouraged by the data of so far, and based on this, we investigating the potential clinical expansion of GD2SADA into pediatric development next year.

We also pleased how our GD2 SADA problem is progressing and look forward to sharing further clinical updates anticipated next year at a medical meeting of choice.

In addition, as Mike mentioned earlier, we are also excited by the FD clearance of RD for our CD38 SADA program in not Heart lymphoma, focusing on both b and t-cell lymphomas, and expect to dose the first patient in this Phase 1 trial next year.

Now with the addition of the CD38 SADA, we have reached the clinical development phase of our SADA platform in both solid and hematological tumors. We do believe in the potential for the novel SADA technology platform to become the targeted radiopharmaceuticals delivery platform of choice in the future, if approved.

Potential altering the treatment landscape across the variety of fences. I will now hand the call over to Bo Kruse who review our financials for the third quarter..

Thank you, Steve, and good morning, everyone. DANYELZA net product revenues of 61 million for the nine-months ended September 30th, 2023 represented an increase of 86% from the 32.8 million reported for the nine-months ended September 30th, 2022. The increase of 28.2 million was primarily driven by an increase in new U.S.

patients and an increase is benefit from expanding international revenues. Our DANYELZA network revenues of 20 million in the third quarter of 2023 represented at 59% increase compared to the third quarter of 2022, and a marginal decline compared to the second quarter of 2023.

As we saw some unevenness in international revenues after a series of inventory stocking orders from our international partners as reported in recent quarters.

During the three and nine-months end of September 30, 2023, we recorded half a million of license revenue in accordance with our sub licensing agreement with [Indiscernible] following the achievement of the marketing authorization for DANYELZA in Mexico in September.

Now, moving to operating expenses, our R&D expenses decreased by 7.1 million and 31 million to 15.4 and 40.8 million for the three and nine-months ended September 30, 2023, respectively, compared to the same periods in 2022.

The net decrease was primarily due to the decrease in spending on deprioritized programs in connection with our restructuring plan announced in January, 2023, which resulted in decreased outsourcing, outsourced manufacturing, outsourced research and supplies, clinical trials, and personnel related costs, the decrease was partially offset by a $4.1 million increase in accrued time-based clinical milestones related to our SADA technology.

Selling, general and administrative expenses decreased by $3.4 million and $16.4 million to $10.2 million and $33.7 million for the three and nine-months ended September 30, 2023 respectively, compared to the same periods in 2022.

The decrease in SG&A for the three months ended September 30, 2023 was primarily driven by cost saving connection with our restructuring plan.

The decrease percent in SG&A for the nine-months ended September 30, 2023, was primarily attributable to a $10.9 million charge related to the departure of our former CEO in Q2 2022 and to a lesser extent a $2.9 million decrease in commercialization expenses, incurred in 2022 in anticipation of a potential omburtamab launch.

Additionally, we recorded a restructuring charge of $1.1 million in SG&A during the nine-months ended September 30, 2023, in connection with the restructuring plan.

However, personnel related costs inclusive of stock-based compensation actually decreased in the three and nine-months ended September 30, 2023 compared to the corresponding period in 2022, due to the impact of the restructuring plan.

We reported a net loss for the quarter ended September 30, 2023 of $7.7 million or $0.18 per share, basic and diluted, compared to a net loss of $27.5 million or $0.63 per share, basic and diluted for the third quarter ended September 30, 2022.

The improvement in our net loss was primarily driven by the increased revenues and the growth of DANYELZA coupled with decreased operating expenses in the third quarter of 2023.

Additionally, we have reported a net loss for the nine-months ended September 30th, 2023 of $20.4 million or $0.47 per share basic and diluted, compared to a net loss of $96.7 million or $2.21 per share basic and diluted for the nine-months ended September 30, 2022.

The decrease in net loss was primarily driven by higher product revenues, lower R&D expenses and lower SG&A expenses, inclusive of the $10.9 million decrease for the charge related to the departure of the former CEO in Q2 2022.

As mentioned earlier, we ended the third quarter of 2023 with cash and cash equivalents of $86.6 million compared to $105.8 million at year end 2022. The decrease was $19.2 million year-to-date.

Importantly, we have reduced our quarterly cash use from $4.7 million to $1.3 million or about 72% during the third quarter of 2023 compared to the second quarter.

We continue to demonstrate responsible cash management along with market expansion for DANYELZA, and we believe we are in position to reduce our projected full-year 2023 operating expenses range from $115 million to $120 million, to $110 million to $115 million, which, together with working capital adjustments, leads to a reduction of the total expected cash burn range for the full-year 2023 from $40 million to $50 million, to $27 million to $32 million.

The consequential impact on our expected cash runway is that we now believe our cash and cash equivalence will sufficiently support our commercial operations and pipeline programs as currently planned in June, 2027. We continue to expect full-year 2023 DANYELZA net product revenues to be in the range of 80 million to 85 million.

As we noted in prior quarters, the underlying assumptions for this guidance are important to understand. No new partnerships or other new business development income is included in the assumptions. For the purpose of this analysis of runway only, the DANYELZA product revenues are assumed to increase by 10% each year from 2024 through 2026.

We indeed hope to see a higher growth rate for DANYELZA 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 our prioritized programs will be advanced at our own expense, and no new programs are assumed at this point for purposes of the analysis.

No further development of the naxitamab program has been assumed for the purpose of this estimate, and we have not assumed any equity or debt offerings or borrowings. We believe Y-mAbs remains well positioned to execute our strategic mission, our priorities, and to support the delivery -.

This concludes the financial update, and I will now turn the call back to Mike..

Thank you for that overview, Bo. Now let’s open the line for questions.

Operator, do you have any questions?.

[Operator Instructions] Our first question comes from Alec Stranahan from Bank of America..

Just a couple from us. First, I think Sue outlined some changes in the commercialization strategy for DANYELZA.

And I know Mike, you are probably still settling into the role, but any what would you say is the single biggest lever that you could pull to help drive growth for DANYELZA and how does that compare to the 10% year over year growth that Bo outlined? And then I’ve got a follow-up..

Well, Alex, thank you for your question. I will pass that to Sue. Sue has a robust plan for our expansion of DANYELZA is in the best position to discuss that.

Sue?.

There are a couple of really important levers that we are able to pull with this campaign. It actually parses out our efficacy data in frontline part in the patients who are in the frontline partial response to induction.

This is consistent with our label, but our current label blended in our relapse and refractory data together by our ability to parse out the efficacy. We are able to demonstrate that a patient who has incomplete response to induction still can have a 46% response rate.

So that really enables us to move the conversation earlier in the patient journey to just after that induction treatment. So we anticipate that as an important growth lever. Currently, about half of our sales are actually in the third line treatment setting after relapse.

So this is a significant movement and opportunity, and we also are excited because we have new data that shows our benefit after failing prior anti GD2 therapy.

Another important area, when you think of the Texan users, we still have a 31% response rate after prior anti GD2 therapy, and some of those patients were able 17% to go and get a complete response. So those are two really important new pieces of data that have been resonating very well as we talk to customers.

And the team is very excited to be rolling out that campaign..

Okay, great. Thanks for that. Just one follow-up onCD38 SADA. As you have been thinking about pushing this one into the clinic, have there been any lessons learned from GD2 SADA, dosing or design of the molecule or the clinical study? Thanks..

Yes, Alex, I appreciate the question on that. I’m going to pass it over to Steen, who can discuss what we have learned from GD2 as we move forward next year into CD38.

Steen?.

Thank you. I think what we have learned so far is, I also alluded to earlier is that it is, until now it has been quite safe to administer this higher program and the SADA protein in particular. So we have seen no serious adverse events related to the protein, and we see nograde 3 plus adverse events related to the protein.

And I think that is something that we bring into the next program when we discuss starting dose of the molecules. We also use, of course, our experience with the nonclinical tox package to bring over to the CD38 program. And we were happy that if they have accepted that program, and now we have do have an [Indiscernible].

So I think we are more confident administering this SADA protein into humans now than work before. And I thought we hope to a little bit more quick dose escalation in the first part of that trial..

Our next question comes from Charles Zhu from Guggenheim..

Mike, congratulations on the new role and also very encouraged to see your excitement over the SADA platform.

On that note regarding the GD2SADA, given your intent now to put out a more substantial data readout, if I heard that correctly in a 2024 medical meeting, as opposed to the year-end R&D day, what quantity as well as types of data could you potentially present? Could we for example, see things like additional whole body planar images or organ and tumor do dosimetry data or how are you thinking about that? Thank you..

Charles. Thank you for your question. I’m going to pass this off to Steen to discuss what information potentially will be available and what we expect to be able to present at a medical meeting this coming year.

Steen?.

Thank you. So for the 2024, we still are in the early part of this human dose escalation study. So this is a safety study as discussed prior.

But definitely, we now already as discussed of those nine patients and we continue enrollment, so we will be able to share both PK data bio-distribution data as initial - also tumor imaging, which shared the first picture we used today. So this kind of information will be ready to be shared during the next year..

Sure. Thank you. And if I could squeeze in one follow-up on that, if you don’t mind. So just looking at some of the initial data that you have presented so far in the GD2 side, maybe something a little bit more granular, but notice that your PK data appears to be on the injected protein concentration.

But just also any color you can provide on radioisotope uptake into the tumor upon the 200 mCi administration?.

This is early days. As I discussed, we have more patients now receiving the 200 milligram. Most of the tumor uptake and the bio-distribution data is collected on the 30 mCi dose. But we also are planning to include scans after the therapeutic dose going forward. So for now, it looks fine. We are still looking for the scalability of the program.

We have dose escalated from 0.1 milligram only. So we still continue two dose escalation of protein. So I think we need to await more robust protein data before we disclose and discuss the targeting..

Excellent. Thanks for taking the questions and definitely look forward to that readout next year..

Our next question comes from Bill Maughan from Canaccord Genuity. Please proceed..

Good morning and welcome Mike. So, two questions for me. When you cite the 57 accounts to DANYELZA, is that all, that have written and currently set up to write DANYELZA or is there sort of a time cut off to weed out any who may be inactive? And then a question on the SADA platform.

Looking forward to potentially trying to read through the GD2 targeting to the CD38 targeting, are there any unique challenges to targeting CD38 versus GD2 that might prevent a seamless read through from that data? Thank you..

Bill, thank you. I appreciate the question. I will take the first part of that, and I will ask Sue to address the accounts that are set up for DANYELZA..

Thanks. Thanks, Bill for the question. So those 57 accounts are set up to use our product. And to give you some perspective, in the United States, only a 152 accounts have ever used any anti-GD2 therapy. So we are well on our way to over a third of those accounts, who are using DANYELZA.

And as we mentioned before, we are seeing deeper penetration of those accounts and also the repeat use in 22 accounts with two or more patients. We are also seeing an increase in the Tier 1 accounts. So we are making good headway from a breadth and a depth standpoint..

And Bill, as far as your second question goes on the GD2 versus CD38, I’m going to pass that to Steve. But understanding that, our team has a very deep and domain knowledge in CD38, which actually makes it very interesting for us moving forward and being able to target the CD38 receptor.

So Steen?.

Yes, there are some differences between the two because going to the CD38, we are entering the hematological space.

And of course, with a two step procedure, we also need to make sure that we don’t have too much bone mar involvement, which is part of the protocol development that we have some limits on how much bone marrow involvement the patient can have in order for us not to put radioactivity directly on the T-cells.

So there is some slight difference in the protocol development and the inclusion exclusion criteria, but else most of those lymphoma patients also have like the lymph nodes of course involved in which we are quite comparable reaching those areas as compared to solid tumors. We are see now with GD2..

Our next question comes from - from BMO Capital Markets..

And Mike congrats on the role here, as CEO.

Just one quick question for me, going back to some of the comments in the 10-Q around the interval of dosing of two to five days for GD2 - where you ultimately think would be sort of an optimal dosing schedule for the technology sort of moving forward as you kind of go through sort of Part A into potentially the Part B expansion..

Thank you for your question and I will pass that to Steen, as he is the majority of the work on the targeting..

So I think, it is too early to say what you could see on the curves, I shared with you earlier on this call. There was a slight shift to the right when you get wind up in the protein concentration. So likely the dose interval will be longer than the two days, depending on how high we can dose up the protein.

And this is a safety precaution, so we will have to wait until we see the B and 10 milligram dose cohorts to see how the blood PK behaves. And this will also together with the absorption into the tumor.

So bio distribution, tumor symmetry will dictate the sweet spot where the best relationship between the free drug in the blood and tumor uptake would count. So for now at least we can say that we actually worse in a good position here in the early part of the trial, but likely they could be longer than two days..

Our next question comes from Mike Ulz from Morgan..

Maybe just a follow-up on the ADA program. You are in the process of advancing the CD38 program, but just curious, thinking about advancing some of those earlier programs such as the HER2 program.

And will you be waiting to see more of insured data from GD2 potentially before deciding to advance some of those programs?.

I appreciate the question. As we start looking at this, we have committed to submitted IND every year and we are going to continue to do that and advance some of the early programs on. We are extremely confident in ADA and what it can do and the problems that it actually addresses in the radiopharmaceutical therapeutic market.

So we are going to continue to invest in the early programs and look to introduce IMEs on an annual basis in order to continue the events, the overall side Next question, operator..

Our next question comes from Robert Burns from HC Wainwright..

Congrats on the quarter and congrats Mike, on your appointment as CEO. Just two questions, maybe two and a half-ish from me.

So since the point of the SADA platform is to reduce radiation associated toxicities and enable greater doses of radiation to be received, I was curious to know whether or what - at what level of radiation would you start seeing dose DLTs and toxicities that would put patients off of therapy if you weren’t given the SADA platform specifically associated with the lutetium? So I want, I’m essentially trying to get at what is the incremental dose level you think you could get given that a base level radiation with SADA?.

Well, Robert, thank you for the question. As we are looking at these safety studies and moving forward on a new platform on specific targeting, we are going to be able to really work with these to tailor make what that response looks like, and also leveling out what some of the patient individual responses look like.

I will pass it to the scene for some additional color. But as we look at these, our primarily goal now is to balance the safety and then move into the efficacy as we move forward with the clinical trials.

Steen?.

Thank you, Mike, and I think I had not much more to add to this because what is really, it is important for us now, and the potential benefit of the SADA platform is that you administer the radioactive nucle when the majority of free protein is out of the system.

So the whole goal here is to differentiate from the one step radio nucle out there in order for us to spare normal tissue. And then we see from there on how much we can add onto the tumors based on that data..

Awesome, thank you. Second follow-up from me.

So when we think about the CD38 SADA, specifically in the multiple myeloma context, what are you viewing as the benchmark there? Are you viewing the benchmark as just what DARZALEX did back in the day or are you looking at these new CD38 targeted agents like Moderna Fast Alpha and Hexa Body CD38? And then are you also enabling prior DARZALEX utilization in those patient populations?.

Robert, thank you for your question on that, and I will pass that over to Steen for what the plans are for the Phase 1 and as we move forward..

So as discussed earlier on this call, we are starting the Phase 1 program in non-Hodgkin lymphoma. So we are actually not dosing multiple myeloma initially, and that’s in order for us to quite quickly create the safety benefit of that molecule.

And I do agree that there is a lot of competition on a CD38 molecule, but this is predominantly in multiple myeloma space, and I think what we do have here is completely different mode of action as compared to the competitors.

So I’m not quite confident we will later go there, but we will initially start the development plan to start the development here in the both the B and T cell space in not Hodgkin lymphoma..

This concludes our question-and-answer session. I would like to turn the floor back over to Mike Rossi for closing comments..

Thank you, operator, and thank you everyone for your participation on today’s third quarter earnings call and for your continued interest in Y-mAbs.

We believe we are in a strong position as we work to deliver multiple potential value-creating milestones with our novel SADA technology, while continuing to drive adoption, growth and expansion of the DANYELZA franchise.

Let me say it again, I’m thrilled to be part of this special company and look forward to working as one team with a patient-first mindset in our mission to fight cancer. Thank you everyone and have a great day..

This concludes today’s teleconference. You may disconnect your lines at this time. Thank you for your participation..