Y-mAbs Therapeutics Q3 2023 Earnings Call Transcript

Quartr
Provided by Quartr
November 14, 2023

There are 12 speakers on the call.

Operator

Good morning, and welcome to Ymabs 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 the prepared remarks. I would now like to turn the conference call over to Courtnee Duggan, Vice President, Investor Relations.

Operator

Please go ahead.

Speaker 1

Thank you, operator, and good morning, everyone. Welcome to our Q3 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 Certain statements that are considered forward looking statements as defined by the Private Securities Litigation Reform Act of 1995.

Speaker 1

Such statements include, but are not limited to, statements about our business model and development, commercialization and product distribution plans, Expectations with respect to early trial data, current and future clinical and preclinical studies 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 Daniella's territory expansion and advancement, SADA, Collaborations for strategic partnerships and the potential benefits thereof expectations related to our anticipated cash burn rate Efficiency 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 potential performance and actual results may differ materially from those Quarterly reports on Form 10 Q for the quarter ended September 30, 2023, and filed with the SEC on November 16, 2023. I would now like to turn the call over to our Founder, Vice Chairman of the Board of Directors and Chief Business Officer, Tom Gadd.

Speaker 2

Thank you, Courtney. Good morning, everybody, and thank you for joining us today. I have with me today our Chief Financial Officer, Beau Kruse our Chief Commercial Officer, Sue Smith and our Chief Scientific Chief Executive Officer, Doctor. Steen Litzbeth. I'm also very excited to welcome our newly appointed President and Chief Executive Officer, Michael Rossi.

Speaker 2

On today's call, Mike will begin by reviewing Q3 global highlights on VENELSA's sales, updates on our ongoing nacitamab clinical trials and high level updates around our SADA program. Sue will then report further insights into our U. S. Daniela sales in the Q3. Next team will provide further details on our Phase 1 DD2 SADA trial currently underway in addition to updates on our CD38 SADA program for which we recently received IND clearance by the U.

Speaker 2

S. FDA. Then Bo will provide an overview of our Q3 financial performance, our cash resources and our full year Before we get into the Q3 results, On behalf of the Ymab'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 6. Our Board had conducted a careful search for the right dedicated leader of our company 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 He joins us from Myeron Technologies, where he served as the President of the Medical Group.

Speaker 2

Prior to that, Mike was the Head of Radioligand Imaging at Advanced Accelerate 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's also a certified nuclear pharmacist. As we continue our efforts to expand the geographic reach of Daniela and further our indication expansion initiatives To maximize the utility of this therapy, we are also incredibly excited about our novel 2 step pre targeted ready immune therapy platform, better known as SADA, and its potential to unlock the value of radiopharmaceuticals in the cancer treatment paradigm. After a reorg in the Q1 of this year, OMS has been positioned as one of the few independent commercial state biotech companies With sufficient financial resources, we've advanced data through proof of concept.

Speaker 2

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 Ymabs 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.

Speaker 3

Thank you, Thomas, for that introduction. It's great to be joining you all today for our YMabs 3rd quarter earnings call. As Thomas mentioned, I've built a 30 plus year career in healthcare with a specific focus on radiopharmaceuticals. Ymabs is a pioneer in pre targeted radio immune therapy with its SADA technology platform, which is a key driver of my own personal excitement about joining Ymabs. SADA stands out as a highly differentiated, pre targeted 2 step platform that is designed to enable precise radioisotope delivery.

Speaker 3

I truly believe that SADA has the potential to shift the treatment paradigm in radiotherapy. In addition, we have the promising Daniela franchise, where we expect to have a growing stream of revenue with our commercial product Daniela to independently support our clinical development work with SADA in a rapidly expanding radiopharma market. With our Phase 1 GD2 SADA trial underway and 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 Daniela. As a reminder, Daniela is approved by the U.

Speaker 3

S. FDA for the treatment of relapsed or refractory high risk neuroblastoma In the bone or bone marrow, patients have demonstrated a partial response, minor response or stable disease with prior therapies. Neuroblastoma is the most common cancer in infants and the 3rd most common cancer in children. In the Q3 of this year, We achieved $20,000,000 in net product sales of Danielza, up 59% from what we recorded in the Q3 of 2022. We continue to make significant progress in our commercialization efforts for Daniela and we are gaining momentum in the U.

Speaker 3

S. With a number of new accounts. We now have 57 sites activated across the U. S. Since Daniela's launch with 9 new accounts so far in 2023.

Speaker 3

We continue to expand our global commercial footprint through partnerships and recently received regulatory approval of Daniela in Mexico, marking our 2nd regulatory approval in Latin America with our partner, Aetum. In addition, As discussed last quarter, our partner Cyclone successfully announced launch Danielle's in China in June of this year. In terms of the number of vials used, in the 1st full quarter since the commercial launch in China, usage in China has 50% of the vials used in the U. S. During the quarter.

Speaker 3

While it's 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 Daniela 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 Daniela through the end of Q3. The continued geographic expansion of Daniela across these regions is an important step in our mission to enable broad Global access for Danielza for patients with high risk relapsedrefractory neuroblastoma. We remain encouraged by the expansion of Daniela, accumulating global net sales of more than 61,000,000 in the 1st 9 months of 2023 as we continue to gain further traction with physicians prescribing Danielza.

Speaker 3

We remain confident in our ability to continue to expand our global commercial market footprint and meet our full year 2020 2023 Daniela net product revenue guidance of between $80,000,000 $85,000,000 Sue will provide further color on Danielle's sales in the quarter shortly. Now Let me briefly comment on our ongoing nexitamod 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 Daniela. In the frontline high risk neuroblastoma setting, we are partnering with the BEAT Childhood Cancer Research Consortium For BCC, in multicenter Phase 2 trial evaluating enaxitamab in combination with standard induction therapy for patients with newly diagnosed high risk neuroblastoma. To date, 9 sites have been initiated and 6 patients have been dosed.

Speaker 3

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, patient recruitment for the trial is projected over a span of 5 years with an anticipated total trial sample size of approximately 282 patients. Our aim for the trial is to demonstrate a superiority in nectlutimab arm versus standard of care. We expect to potentially initiate the new randomized study in the Q2 of next year. In osteosarcoma, we're continuing to work with Memorial Sloan Kettering Cancer Center or MSA on its multicenter We anticipate MSK to provide a data readout from this Phase onetwo trial in Q4 of 2024.

Speaker 3

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 axitamab based chemoimmunotherapy HITS trial in patients with chemoresistant high risk neuroblastoma in the journal cancers. In this trial, patients who received hits Immediately after induction had a higher response rates, 47% versus 18% And Superior estimated 3 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 chemoresistant 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.

Speaker 3

Now moving on to SADA. Our novel SADA technology platform is a key driver of my own personal excitement about joining Ymabs. Throughout my extensive career in various radiopharma leadership roles, I've had the privilege to witness the development of numerous breakthrough technological platforms. However, SADA, which is licensed by BioMabs from MSK and the Massachusetts Institute of Technology in 2020, stands out as a highly differentiated, pre targeted 2 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.

Speaker 3

Steve 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 Our first program, GD2 SADA, began Phase 1 development earlier this year. To date, we have completed dosing cohorts 12 currently administering doses of Cohort 3. Despite the limited patient sample size to date, we're very pleased with the positive progress we've 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're 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 and D Day event in December.

Speaker 3

Our second program, CD38 SADA, Recently received IND clearance from the U. S. FDA to enter clinical development. We're particularly excited about the program given our We anticipate exploring potential partnership opportunities as this program advances. The Phase 1 dose escalation, open label, single arm, multicenter 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.

Speaker 3

We believe there remains a Significant unmet medical needs 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 and B7 H3 constructs. As we look ahead to the rest of 2023 and beyond, We believe we are well positioned with $86,600,000 in cash and cash equivalents as of the end of Q3 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 $1,300,000 in the Q3 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 further Daniella's sales growth, which serves as the financial foundation to propel our SADA technology through clinical development with our 2 lead programs.

Speaker 3

We believe we're 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 am thrilled to be here at YMAM 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. Daniela's sales in further detail.

Speaker 3

Sue?

Speaker 4

Thank you, Mike, and good morning, everyone. I'm pleased to be with the commercial to share the commercial progress of Daniela in the U. S. We increased Danielle'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 We continue to see an upward trend of sales growth since the initial launch back in 2021.

Speaker 4

Our percent growth since launch is performing well above where unituxim was at 3 year post launch, 45% versus 22% growth, and we believe we have room for continued growth. As Mike mentioned, we Let me review key highlights from Danielle's U. S. Sales in the Q3. At the close of the Q3 of 2023, we had a total of 44 new patient starts year to date.

Speaker 4

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 Daniela demand in the U. S. During the Q3. With 57 accounts now having used Daniela around the U.

Speaker 4

S, we have seen 22 accounts treat 2 or more patients in the 1st 9 months of this year. We believe physicians are getting more comfortable using Daniela with 36 Healthcare providers having prescribed Danielza in the 1st 9 months of this year, including 7 HCPs starting 2 or more patients in the 1st 9 months of this year. Since launch, a total of 88 doctors have prescribed Danielza and 28 of them Have started treatment on 2 or more patients as of September 30, 2023. Our U. S.

Speaker 4

Commercial sales team has received increasingly HCP feedback on Daniela through over 2,500 customer interactions in the 1st 9 months of this year and over 6,400 interactions since our launch in 2021. We also continue to see institutional adoption of Danielza, 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. Ymabs remains a leader in the U. S. Anti GD2 market, a highly important area of pediatric cancer in a rare disease market with a flat incidence rate.

Speaker 4

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 Daniela campaign. The new campaign repositions and elaborates on Daniela's differentiating characteristics in the treatment of high risk neuroblastoma for patients who have 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 Daniela's performance in patients with an incomplete response to induction therapy and also patients who are relapsed, which are 2 different patient groups. In addition, it demonstrates Danielle's response in children after prior anti GD2 therapy.

Speaker 4

I am 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, Sue will discuss the latest progress of our SADA platform in further detail.

Speaker 5

Thank you, Sue, and good morning, everyone. I'm pleased to provide you with an update on our SADA programs, beginning with the DD2 SADA. Our Phase 1 trial evaluating the safety and tolerability of DD2 SARA in the treatment of DD2 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 3 parts. Part A explores Dode finding of the SADA molecule itself and testing the dose intervals of 2 to 5 days between the protein administration and the Lutetium dota payload.

Speaker 5

Part B will determine the optimal dose of Lutetium dota and Part C evaluates Dose escalation is based on 2 patients in Cohorts 1 and 2 followed by modified 3 plus 2 design. And it's important to emphasize that In each cohort, patients will be observed after dosing in a so called 6 weeks dose limiting toxicity period or DLT period. Currently, we are still in Part A and the trial is progressing very well. We have dosed 5 patients in the 3rd quarter. At present, we have 6 active sites with 3 sites expected to be activated during the Q4 of this year.

Speaker 5

We have advanced through the first two cohorts and are now dosing patients in cohort 3. We now have More patients receiving the 200 milligram dose of emeticio delta. I would like to emphasize that we are still in part A of this trial, which is We are pleased with what we have seen 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.

Speaker 5

And of note, We can dose SADA protein with no severe or severe serious pain signals detected. Today, we also can announce that we believe to have demonstrated Proof of concept for the DD2 SADA by demonstrating that SADA molecules can bind and bind to tumors and that the radionuclide target SADA is visualized on the spec CT scans performed. It's 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 of Sartell's development program. As seen on next slide, we are on the opinion that the exposure, the blood PK The data includes 4 patients in each of the 2 treatment groups, So 8 patients in total. The patient dosed with a 0.3 milligram per kilogram protein, represented here in blue, And the patient dose with a 1 milligram per protein represented here in purple are comparable and support the dose intervals of On next slide, we for the first time are sharing a SPECT CT scan Demonstrating tumor uptake in one patient.

Speaker 5

This patient this scan was conducted after an imaging dose of 30 milligrams only. We are very encouraged by the data observed so far. And based on this, we The potential clinical expansion of DD2 SARA into pediatric development next year. We're also pleased how our DD2 SARA program is In addition, as Mike mentioned earlier, we are also excited by the FDA clearance of R and for our CD38 SARA program in large Hodgkin 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 SARA, we have reached We do believe in the potential for the NovoCyta technology platform to become the targeted radiopharmaceuticals delivery platform of choice in the future, if approved, potentially altering the treatment landscape across I will now hand the call over to Bo Kosen, who will review our financials for the Q3.

Speaker 6

Thank you, Steen, and good morning, everyone. Daniela net product revenues of $61,000,000 for the 9 months ended September 30, 2023 represented an increase of 86% from the $32,800,000 reported for the 9 months ended September 30, 2022. The increase of $28,200,000 was primarily driven by an increase in new U. S. Patients And an increase will benefit from expanding international revenues.

Speaker 6

Our Danielson net product revenues of $20,000,000 in the Q3 of 2023 Represented a 59% increase compared to the Q3 of 2022 and a marginal decline compared to the Q2 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 3 9 months ended September 30, 2023, we recorded 500,000 Now moving to operating expenses. Our R and D expenses decreased by $7,100,000 $31,000,000 to $15,400,000 $40,800,000 for the 3 9 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 and 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 $4,100,000 increase in accrued Selling, general and administrative expenses decreased by $3,400,000 $16,400,000 to $10,200,000 $33,700,000 for the 3 9 months ended September 30, 2023, respectively, Compared to the same periods in 2022, the decrease in SG and A for the 3 months ended September 30, 2023 was primarily driven by cost saving in connection with our restructuring plan.

Speaker 6

The decrease in SG and A for the 9 months ended September 30, 2023, was primarily attributable to a $10,900,000 charge related to the departure Decrease in commercialization expenses incurred in 2022 in anticipation of a potential omburtamab launch. Additionally, we recorded a restructuring charge of $1,100,000 in SG and A during the 9 months ended September 30, 2023 in connection with the restructuring plan. However, personnel related costs, inclusive Stock based compensation actually decreased in the 3 9 months ended September 30, 2023 compared to the corresponding period in 20 22 due to the impact of the restructuring plan. We reported a net loss for the quarter ended September 30, 2023 of $7,700,000 or $0.18 per share, basic and diluted, compared to a net loss of $27,500,000 or $0.63 per share basic and diluted for the Q3 ended September 30, 2022. The improvement in our net loss was primarily driven by the increased revenues and the growth of Daniella coupled with decreased operating expenses in the Q3 of 2023.

Speaker 6

Additionally, we reported a net loss for the 9 months ended September 30, 2023 of $20,400,000 or $0.47 per share basic and diluted compared to a net loss of 96,700,000 at $2.21 per share basic and diluted for the 9 months ended September 30, 2022. The decrease in net loss was primarily driven by higher product revenues, lower R and D expenses and lower SG and A expenses, inclusive of the 10 As mentioned earlier, we ended the Q3 of 2023 with cash and cash equivalents of 86 $600,000 compared to $105,800,000 at year end 2022. The decrease was $19,200,000 year to date. Importantly, we reduced our quarterly cash use from $4,700,000 to $1,300,000 or about 72% during the Q3 of 2023 compared to the Q2. We continue To demonstrate responsible cash management along with market expansion For Danielson, and we believe we're in position to reduce our projected full year 2023 operating expenses range from $115,000,000 to $120,000,000 to $107,000,000 to $115,000,000 which, Together with working capital adjustments leads to a reduction of the total expected cash burn range for the full year 2023 The consequential impact on our expected cash runway We now believe our cash and cash equivalents will sufficiently support our commercial operations and pipeline programs as currently planned in 2027.

Speaker 6

We continue to expect full year 2023 Danielson net product revenues to be in the range of $80,000,000 to $85,000,000 As we noted in prior quarters, the underlying assumptions For this guidance, it's 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 Danielson product revenues are assumed to increase by 10% each year from 2024 through 26. We indeed hope to see a higher growth rate for Danielson as we execute our refined commercial strategy and work to deliver new 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 inverterumab program has been assumed for the purpose of this estimate, We have not assumed any equity or debt offerings or borrowings.

Speaker 6

We believe YMAPS remains This concludes the financial update. And I'll now turn the call back to Mike.

Speaker 3

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

Operator

Thank you. We will now be conducting a question and answer session. Our first question comes from Alec Stranahan from Bank of America. Please proceed.

Speaker 7

Hey, guys. Thanks for taking our questions. Just a couple from us. First, I think Sue outlined some changes in the commercialization strategy for Daniela, and I know Mike, you're 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 Daniela? And how does that compare to the 10% year over year growth that Beau outlined?

Speaker 7

And then I've got a follow-up.

Speaker 3

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

Speaker 4

Thanks Mike. Thanks Alex for your question. There are a couple of really important levers that we're able to pull with It actually parses out our efficacy data in frontline 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 relapsed 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 So that really enabled 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 3rd line treatment setting after relapse.

Speaker 4

So this is a significant movement and opportunity. And we also are excited because we have new data that shows our benefit after failing at prior anti GD2 therapy. Another important area when you think of the, unituxent 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 2 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.

Speaker 7

Okay, great. Thanks for that. Just one follow-up on CD38 SADA. As you've 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.

Speaker 3

Yes, Alex, I appreciate the question on that. I'm going to pass it over to Steve, Who can discuss what we've learned from GD2 as we move forward next year into CD38. Dave?

Speaker 5

Thank you. I think what we learned so far is I also alluded to earlier is that it's Until now, it has been quite safe to administer the SADA program and the SADA protein in particular. So we have seen no serious adverse events Related to the protein, we see no GRID3 plus adverse event related to the protein. And I think that is something that bring it to the next program when we discuss starting dose of the molecules. We also use, of course, our experience with the non clinical tox package to bring over to the 38 program and we're very happy that GSD have accepted that program and now we have to have an open mind.

Speaker 5

So I think we are more confident administering the cytoplrotein into use now than we were before. And as such, we hope to a little bit more quick Dose escalation in the first part of that trial.

Speaker 7

Thank you.

Speaker 3

Thank you, Steve. Next question, operator?

Operator

Our next question comes from Charles Zhu from Guggenheim. Please proceed.

Speaker 8

Hey, good morning, everyone, and thanks for taking our questions. And Mike, congratulations on the new role and also very encouraged to see your excitement over the SATA On that note, regarding the GD2 start up, given your intent now to put out a more substantial data readout, If I heard that correctly, in a 2024 Med Medical meeting as opposed to the year end R and D Day, what quantity as well as types of data could you potentially Can we, for example, see things like additional whole body planar images or organ and tumor dosimetry data or how are you thinking about that? Thank you.

Speaker 3

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.

Speaker 5

Thank you. So for the 2024, we still are in the early part of this new human dose escalation So this is a safety study as discussed prior. But definitely, we now already, as discussed, have dosed 9 patients and we continue enrollment. So we will be able to share both PK data, biodistribution data as initial also So my imaging, which we shared the first picture with you today. So this kind of information will be ready to be shared during the next year.

Speaker 8

Yes. 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've presented so far in the G2 SADA, maybe something a little bit more granular, but notice that your PK data Appears to be on the injected protein concentration, but just also how any color you can provide on radioisotope uptake into the tumor upon the 200 millicuria administration. Thank you.

Speaker 3

Thank you, Charles Steen.

Speaker 5

This is early days. As I discussed, we have more patients now receiving the 200 milligrams. Most of the tumor uptake and the biodistribution data is collected on the 30 milligrams dosimetry 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.

Speaker 5

We had dose escalated from 0.1 milligram only, so we are still continuing the dose escalation of protein. So I think we need to wait more robust protein data before we disclose and discuss metargotene.

Speaker 8

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

Speaker 3

Very good. Next question, operator?

Operator

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

Speaker 9

Hey, good morning and welcome Mike. So two questions from me. When you cite the 57 accounts for Daniela, Is that all that have written and currently set up to write, Danielza? 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.

Speaker 9

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.

Speaker 3

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

Speaker 4

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 152 accounts have ever used any anti GD2 therapy. So we're well on our way to over a third of those accounts who are using Danielza. And as we mentioned before, we're seeing deeper Penetration of those accounts and also, the repeat use in 22 accounts with 2 or more patients.

Speaker 4

We're also seeing an increase in the Tier one accounts. So we're making good headway from a breadth and a depth standpoint.

Speaker 3

And Bill, as far as your second question goes on the GD2 versus CD38, I'm going to pass that to Steen, 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 Steve?

Speaker 5

Thank you. Yes. There are some differences between the cohorts. Going to the CD38, we are entering the hematological space. And of course, with a 2 step development that we have some limits on how much bone marrow involvement the patient can have in order for us not to put radioactivity So there are 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're seeing now in DD2.

Speaker 3

Very good. Thank you. Thank you for your questions, Bill. Operator, next question.

Operator

Our next question comes from Etzer DeRout from BMO Capital Markets. Please proceed.

Speaker 10

Great. Thanks for taking Question and Mike, congrats on the role here as CEO. Just one quick question for me going back to sort of some of the comments in the 10 Q around The interval of dosing of 2 to 5 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 to sort of Part A into Thank

Speaker 5

you.

Speaker 3

Esther, thank you for your question. And I will pass that to Steve

Speaker 5

Thank you, Mike. So I think it's Too early to say what you could see on the curves I shared with you earlier on this call. There was a slight To the right, when you get wind up in the protein concentration, so likely the dose interval will be longer than the 2 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 10 milligram dose cohorts to See how the blood PK behaves and this will also together with the absorption into the tumor, so biodistribution, tumor dosimetry will dictate the sweet Where the best best relationship between free drug in the blood and tumor uptake would be found. So for now, at least we can say that we actually was in a good position here in the early part of the trial, but likely they could be longer than 2 days.

Speaker 6

Great. Thank you.

Operator

Our next question comes from Mike Ulz from Morgan Stanley. Please proceed.

Speaker 11

Good morning and thanks for taking the question. Maybe just a follow-up on the SADA program. You're in the process of advancing the CD38 program, but just curious how you're thinking about advancing some of those Earlier programs such as the HER2 program and will you be waiting to see more mature data from GD2 potentially before deciding to advance

Speaker 3

Mike, I appreciate the question. As we start looking at this, we've committed to submitting an IND every year And we are going to continue to do that and advance some of the early programs on. We're extremely confident in SADA 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 programs and look to introduce IMV's on an annual basis in order to continue to advance the overall product platform. Great.

Speaker 3

Thank

Speaker 5

you.

Speaker 3

Thank you, Mike. Next question operator?

Operator

Our next question comes from Robert Burns from H. C. Wainwright. Please proceed.

Speaker 7

Hey, guys. Congrats on the quarter and Congrats, Mike, on your appointment as CEO. Just two questions, maybe 2.5 for me. So since the point of the Saada platform is to reduce radiation Associated toxicities enable greater doses of radiation to be received. I was curious to know whether or at what level Would you start seeing those DLTs and toxicities that would put patients off of therapy if you weren't Given the Sona platform, specifically associated with the Lutetium, I want I'm essentially trying to get at what's the incremental dose level you think you could get given a base level radiation without SADA.

Speaker 3

Well, yes, Robert. Thank you for the question. As we're looking at these safety studies and moving forward, on a new platform on specific targeting, We're 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

Speaker 2

I'll pass

Speaker 3

it to Steve for some additional color. But as we look at these, our primary goal now is to balance the Safety and then move into the efficacy as we move forward with the clinical trials. Steve?

Speaker 5

Thank you, Mike. And I thank you. I have not much more to add to this because what's really important for us now And the potential benefit of the SADA platform is that you administer the radioactive nuclei when the majority of free The protein is out of the system. So the whole goal here is to differentiate from the 1 step radionuclides out there In order for us to spare a normal issue and then we will see from there on how much we can add on to the tumors based on that data.

Speaker 7

Awesome. Thank you. A second follow-up for me. So when we think about the CD38 SADA, Specifically in the multiple myeloma context, what are you viewing as a benchmark there? Are you viewing the benchmark as just what DARZALEX did back in the day?

Speaker 7

Or are you looking at these new CD38 targeted agents such as like Modercafast, Ulfalfa and Hexibody CD38. And then are you also enabling prior Darzalex utilization in those patient populations.

Speaker 3

Robert, thank you for your question on that and I'll pass it over to

Speaker 5

Discussed earlier on this call, we are starting the Phase 1 program in non Hodgkin lymphoma. So we're actually not dosing multiple myeloma initially. That's in order for To quite quickly create the safety benefit of that molecule. And I do agree that there's a lot of 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.

Speaker 5

So I'm quite confident we will later go there, but we will initially start the development plan to

Speaker 3

Thank you, Robert. Operator, are there any other questions?

Operator

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

Speaker 3

Thank you, operator, and thank you everyone for your participation Today's Q3 earnings call and for your continued interest in WiMAX. We believe we're 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 Daniela 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 and our mission to fight cancer.

Operator

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

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Earnings Conference Call
Y-mAbs Therapeutics Q3 2023
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