Q3 2024 Y-mAbs Therapeutics Inc Earnings Call
and many more. Thank you. Thank you.
Speaker Change: Good morning and welcome to YMAB's Therapeutics, Inc. third quarter conference call for 2024. At this time, all participants are in a listen-only mode. Instruction 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 YNAB Third Quarter 2024 Financial Results Conference Call. We issued a press release with our results this morning before market open.
Courtney Dugan: The press release and accompanying slides are available on the IR section of our website.
Courtney Dugan: 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 Form Act of 1995.
Courtney Dugan: Such statements include, but are not limited to, statements about our business model, commercialization, and product distribution plans, expectations with respect to clinical trial data,
Courtney Dugan: Expectations related to current and future clinical and preclinical studies and our research and development programs and regulatory submissions. Potential regulatory, marketing, and reimbursement approvals.
Courtney Dugan: Collaborations or strategic partnerships and the potential benefits thereof. Expectations related to our anticipated cash runway and cash investment and the sufficiency of our cash resources and assumptions related thereto.
Courtney Dugan: financial guidance and estimates for 2024 and beyond and other statements that are not historical facts.
Thank you.
Courtney Dugan: Because forward-looking statements involve risks and uncertainties, actual results may differ materially from those expressed or implied by such statements.
due to a variety of factors.
Courtney Dugan: including those risk factors in the company's previously filed annual report on Form 10-K for the year ended December 31st, 2023, and its quarterly report on Form 10-Q for the quarters ended March 31st and June 30th, 2024.
Courtney Dugan: and the company's quarterly report on Form 10-Q for the quarter ended September 30, 2024 to be filed with the SEC today.
Speaker Change: I would now like to turn the call over to our President and CEO, Mike Rossi.
Mike Rossi: Thank you, Courtney. Good morning and thank you for joining us. I have with me today our Chief Commercial Officer, Sue Smith, our Chief Medical Officer, Dr. Vignesh Rajah, and our Chief Financial Officer, Pete Pfreundschuh.
Mike Rossi: This morning, I will begin by reviewing key financial and operational highlights from the third quarter of 2024, including Daniela's sales performance and the clinical progress of our radiotherapy clinical programs utilizing our self-assembly, disassembly, pre-targeted radio-immune therapy, or SATA print technology platform.
Pete Pfreundschuh: Next, Schuh will provide details on our global Danielle's of sales in the third quarter.
Pete Pfreundschuh: Vignesh will then provide updates around our ongoing Maxitimab ISS clinical trials.
Pete Pfreundschuh: Then Pete will review our third quarter 2024 financial performance, our cash resources, and reiterate our full 2024 guidance before we open the line for Q&A. Let's begin with the key highlights for the third quarter of 2024, starting with Danielza.
Pete Pfreundschuh: Danielza, the brand name for a humanized anti-GD2 therapy, Nexidimab, is FDA approved for the treatment of children aged one year and older with relapsed refractory high-risk neuroblastoma in the bone or bone marrow.
Pete Pfreundschuh: Neuroblastoma continues to be the most common cancer in infants, and the third most common cancer in children.
Pete Pfreundschuh: Danielle is specifically designed for children who have had an incomplete response to induction or relapse therapy and also have disease in the bone and or bone marrow.
Pete Pfreundschuh: While designated as an outpatient therapy, Danielza can also be administered in the inpatient setting depending on the specific needs of the child.
Pete Pfreundschuh: We are nearing the four-year mark since the commercial launch of Danielle's in the U.S.
Pete Pfreundschuh: Despite some of the headwinds around competition we saw from the second quarter carry into the third quarter this year.
Pete Pfreundschuh: Our overall commercial progress since launch back in 2021 shows encouraging continued progress in terms of the number of sites we are able to reach and the patients we are able to treat with Danielza.
Pete Pfreundschuh: In the third quarter, we added three new U.S. Danielza accounts and saw a 5% increase in Danielza demand compared to the second quarter of this year.
Pete Pfreundschuh: This signals to us increasing physician adoption of Danielza across both new and existing accounts and more patients having access to this important anti-GD2 therapy.
Our team continues to drive important initiatives around direct-to-parent education.
Pete Pfreundschuh: and patient advocacy efforts with the goal of thoroughly understanding the current gaps in patient care and increasing awareness of Danielza as an important treatment option for children with relapsed refractory high-risk neuroblastoma to achieve a complete response and remission.
Pete Pfreundschuh: You will hear more from Sue on specifics around Daniela's performance across our U.S. and ex-U.S. markets shortly.
Pete Pfreundschuh: In the third quarter, we achieved total net revenue of $18.5 million, down 10% from the same period in 2023.
Pete Pfreundschuh: The decrease was due to a decline in net product revenues in both the U.S. and our ex-U.S. markets in the quarter, in addition to a half million dollar in licensing revenue recorded in the third quarter of 2023.
Pete Pfreundschuh: For the first 9 months of the year, we achieved total net revenue of $61.2 million, relatively consistent with the same period in 2023.
Pete Pfreundschuh: We had several corporate updates in the quarter that support our continued global commercial and indication expansion efforts.
Pete Pfreundschuh: We are thrilled to have received notification of the accepted patent extension for Danielza, U.S. 9315-585 last month.
Pete Pfreundschuh: Our U.S. patent will now expire February 5, 2034, extended from June 20, 2031.
Pete Pfreundschuh: In the third quarter, we entered into a lease agreement for a future YMAPS headquarters in Princeton, New Jersey.
Pete Pfreundschuh: We expect the construction of the premises will be completed in the first half of 2025 and the lease will run for 10 years and 9 months from the completion date.
Pete Pfreundschuh: Earlier this week we announced that we have entered an exclusive license agreement and distribution agreement with Noble Pharma for the development and commercialization of Danielza in Japan, if approved in the region.
Pete Pfreundschuh: We received an upfront payment of $2 million, which will be recorded in the fourth quarter of this year.
Pete Pfreundschuh: Under the terms of the agreement, we are entitled to receive up to US$31 million in product and commercial milestone payments in addition to profit sharing on the commercial sales of Danielza if successfully approved and commercialized in Japan.
Pete Pfreundschuh: Japan represents an important Asia region for Danielza, and we look forward to partnering with Noble Pharma in expanding access to Danielza to the region, if approved there.
Pete Pfreundschuh: Our partner TR Pharm launched the Danielza Named Patient Program in Turkey in the third quarter of 2024. We are very pleased with how the launch is progressing and look forward to providing further updates in future quarters.
Pete Pfreundschuh: In addition, with our Latin American partner, ADM, we plan to submit a regulatory filing for marketing approval of Danielza in Argentina later this year.
Pete Pfreundschuh: Overall, we remain confident in our U.S. commercial strategy and trajectory in the continued ex-U.S. expansion of Danielza to fill important gaps in the treatment of children with relapsed or refractory high-risk neuroblastoma.
Let's now shift to our SADA PRIP programs.
Pete Pfreundschuh: Starting with our phase one trial, evaluating the safety and tolerability of GD2-SADA for the treatment of GD2-positive solid tumors.
Pete Pfreundschuh: This is a BASCA trial looking at small cell lung cancer, sarcomas, and malignant melanomas.
Pete Pfreundschuh: In the fourth quarter, we opened Cohort 6 to include adult patients 16 years of age or above with high-risk neuroblastoma.
Pete Pfreundschuh: As a reminder, this Phase 1 Dose Escalation Single-Arm Multi-Center Safety Study has three parts.
Part A, which we are currently in.
Pete Pfreundschuh: is structured to demonstrate the safety profile of the protein while it explores dose finding for the GD2 SADA molecule and testing of the dose intervals of 2 to 5 days between the protein and the lutetium DOTA payload.
Pete Pfreundschuh: Part B aims to determine the optimal dose of Lutetium-177 DOTA, and Part C will evaluate the safety and initial signs of efficacy using repeat dosing.
Pete Pfreundschuh: To date, we have six sites open and have a total of 20 patients in Part A of this trial. We have completed Cohorts 1 through 5 using a radioactive payload of up to 200 millicuries of lutetium and a 2-5 day interval between SADA protein and payload.
Pete Pfreundschuh: 1 milligram per kilogram and 3 milligram per kilogram of protein appears to match our preclinical models.
in the terms of clearance data.
Pete Pfreundschuh: and blood pre-K profiles from patients are comparable and supportive of the current dose interval between two and five days.
Pete Pfreundschuh: We continue to be encouraged by what we have seen so far.
Pete Pfreundschuh: 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.
Pete Pfreundschuh: Based on the SPECT CT scans and PK activity we have seen to date, we believe we have demonstrated proof of concept in humans that GD2 SADA can both find and bind to tumors.
Pete Pfreundschuh: It is important to note that these early data are not complete and not necessarily indicative of a full result or ultimate success of the trial or the SADA development program.
Pete Pfreundschuh: We are on track to complete Part A of this Phase I study by the end of this year and will look to present a full data set from Part A in the first quarter of 2025.
Pete Pfreundschuh: For the anticipated data readout from Part A of the trial, our objective is to demonstrate the safety profile of the protein and determine the optimal timing to administer the radionuclide, all of which will inform Part B.
Pete Pfreundschuh: We also plan to show additional scan images and PK data.
Pete Pfreundschuh: Because we elected to open a sixth cohort to include adults with neuroblastoma, we're awaiting the full data from Part A before filing an IND for a GD2-SADA Phase I trial in pediatric neuroblastoma.
Pete Pfreundschuh: Our second SATA PRIT program is CD38 SATA, which we are first studying in the treatment of non-Hodgkin's lymphoma, focusing on B-cells and T-cell lymphoma.
This is our first SADA program in circulating tumors.
Pete Pfreundschuh: Our planned Phase 1 follows the design comparable to our GD2-SADA Phase 1 trial, which you can see here.
Pete Pfreundschuh: We have selected the first six sites and activated two sites and expect to dose the first patient by the end of 2024.
Pete Pfreundschuh: In addition, we look forward to highlighting free clinical CD38 SADA data in a poster presentation at the American Society of Hematology annual meeting on December 7th in San Diego.
Pete Pfreundschuh: The abstract, titled CD38-SADA, A Self-Assembling and Disassembling Bispecific Fusion Protein for Two-Step Pre-Targeted Radioimmune Therapy of Non-Hodgkin's Lymphoma, is available on the ASH website.
Pete Pfreundschuh: We are very excited for the potential of SadaPrit to fill much-needed gaps for patients across a range of cancers and potentially other serious diseases, and we continue to believe in its potential advantages in manufacturing, administration, and logistics with traditional radiopharmaceuticals.
Pete Pfreundschuh: We look forward to providing further updates on our SATA PRIP programs going forward.
Across both are Danielzit and SadaPrint platforms.
Pete Pfreundschuh: We are committed to advancing a potential new generation of therapies through clinical development aimed at improving outcomes and long-term quality of life for patients and their families.
Speaker Change: I will now pass the call over to Sue Smith to provide further color on Global Daniela sales for the third quarter of 2024.
Sue Smith: Thank you Mike and good morning everyone. Despite seeing some of the same headwinds we saw in the second quarter carrying to the third quarter, we're pleased with the overall commercial progress of Danielza since the initial commercial launch in the U.S. and across our ex-U.S. markets.
Sue Smith: Danielza is an important anti-GD2 therapy for the physician toolbox in the treatment of patients with relapsed refractory high-risk neuroblastoma in the bone or bone marrow.
Sue Smith: Its key unique features, including outpatient administration and response in bone and or bone marrow, makes Danielza an important treatment option for patients and caregivers alike.
Sue Smith: In the third quarter of 2024, total U.S. Danielsa net product revenues were $15.3 million, representing a 5% decrease compared to the same period in 2023, primarily driven by a change in estimate from Medicaid claims.
Sue Smith: While we encountered continued competition from the launch of a new market entrant for maintenance therapy in addition to ongoing clinical trial activity, we still saw increases in key performance indicators.
Sue Smith: A total of 68 accounts have now used Danielza around the U.S. since its initial launch in 2021, with three new accounts added in the third quarter of 2024.
Sue Smith: Daniels' estimated total share of the U.S. anti-GD2 market remains steady at approximately 15% as of September 30th, 2024.
Thank you.
Sue Smith: We're excited to see physician utilization of Danielza continue to grow. Thirty-four health practitioners started patients on Danielza in the nine months ended September 30, 2024, with seven physicians starting treatment on two or more patients.
Sue Smith: Since launch, a total of 113 healthcare providers have prescribed Danielza, and 34 of those have started treatment on two or more patients.
Sue Smith: Our dedicated U.S. commercial sales team continues to receive positive healthcare provider feedback on Danielza through ongoing customer interactions.
Sue Smith: In addition, we continue to see institutional adoption of Danielza, which has been added to two hospital formularies in the third quarter of 2024, bringing the total since launch to 48 hospital formularies as of September 30, 2024.
Sue Smith: Now, turning to our Ex-U.S. commercial progress, Ex-U.S., our third quarter 2024 Danielle's and Net product revenues were $3.1 million.
Sue Smith: A decrease of 19% compared to the third quarter of 2023. The decrease was primarily driven by a decline in volume from our WEP patient access program in Europe, which had an initial stocking order in the third quarter of 2023.
Sue Smith: The third quarter marked the first recorded sales in Turkey with our partner TR Farms and the second consecutive quarter of Daniella's sales in Brazil and Mexico, led by our Latin American partner, ADM.
Sue Smith: We expect to see additional adoption over the coming quarters and look forward to providing further updates as we learn more about market dynamics in these regions.
Sue Smith: In Asia, our partner Cyclone continues to expand use of Danielza in China and is gearing up to launch Danielza in Hong Kong following its approval in the region last quarter.
Sue Smith: Our team is committed to finishing the year with strong fourth quarter performance of Danielza in the U.S. and continuing to support our ex-U.S. partners as they expand access to Danielza across their respective regions.
For more information visit www.FEMA.gov
Sue Smith: We are confident in the potential to position Danielza as the anti-GD2 therapy of choice in relapsed refractory high-risk neuroblastoma in the bone and or bone marrow to both physicians and caregivers.
Speaker Change: and expect to see a continued overall upward trend of sales growth over the long term. We look forward to providing further updates throughout the coming year. I will now pass the call to Vignesh.
Speaker Change: Thank you Sue and hello everyone. I'm pleased to provide a brief update on our ongoing investigative sponsor Nexidermab Clinical Trials.
Vignesh Rajah: Let's start with Memorial Sloan Kettering Cancer Center's Phase 2 clinical trial evaluating Nexidermab in patients with second-line relapsed osteosarcoma.
Vignesh Rajah: As we shared during our second quarter earnings call, based on a draft abstract our team received from MSK back in June,
Vignesh Rajah: The trial did not meet its primary end point of 16 event-free patients at 12 months and instead stated that there were 14 event-free patients at 12 months.
Vignesh Rajah: MSK is expected to present this data at a medical meeting by the end of this year, after which time our team plans to analyze the full study results and evaluate next steps.
Thank you. Thank you. Thank you.
Vignesh Rajah: In the frontline high-risk neuroblastoma setting, our partner, the BEAT Childhood Cancer Research Consortium, or BCC, is leading a multi-center phase 2 trial evaluating maxidermab in combination with standard induction therapy for patients with newly diagnosed high-risk neuroblastoma.
Vignesh Rajah: As of the end of the third quarter, the BCC had 22 active sites and treated 11 patients with recruitment ongoing.
Vignesh Rajah: The amended protocol for the transition to a comparison with an external control is currently being developed.
Vignesh Rajah: We expect the trial to transition from a single-arm trial design to a comparative trial with an external control arm that reflects current standard of care for induction therapy with a comparable patient population that is carefully selected and propensity score matched.
Vignesh Rajah: Our aim for the trial is to demonstrate superiority in complete response rates at the end of induction therapy in the nexidermab arm compared to the standard of care.
Vignesh Rajah: In Advanced Breast Cancer, we are partnering with The Ohio State University on a Phase 1B trial investigating TGF-beta-NK cells, gemcitabine, and maxidermab in patients with GD2-positive metastatic breast cancer.
Vignesh Rajah: Patient recruitment for the trial was initiated in the third quarter of 2024.
Vignesh Rajah: As per the study design, follow-up for dose-limiting toxicities with a combination of gemcidabine and NK cells need to be completed, and the persistence of NK cells in the blood needs to be confirmed before the addition of mexidermab.
Thank you. Good night. Good night.
Speaker Change: Upon the outcome of this trial, we would consider moving forward with a multi-center Phase 2 trial.
Speaker Change: In patients with the refractory Ewing sarcoma, the Institute of Mother and Child in Poland is leading a randomized phase 2 trial evaluating the efficacy and safety of mexidermab. This trial was initiated during the fourth quarter of 2023. Three patients have been dosed in the mexidermab arm to date and recruitment is ongoing.
We expect a total of 16 patients in that arm.
The trial is expected to be completed in 2028.
Speaker Change: In addition we're in discussions with the MD Anderson Cancer Center to initiate a multi-center phase one study to evaluate the addition of Nexidermab to current standard of care in the treatment of metastatic triple negative breast cancer.
Thank you.
Speaker Change: The study is expected to assess the safety of this combination as well as provide an early indication of objective response rate in patients with metastatic triple negative breast cancer who have received at least one prior line of systemic therapy for metastatic disease.
Thank you.
Speaker Change: The study, which is anticipated to start in the first quarter in 2026, will further inform us on a future Phase II program in triple negative breast cancer.
Speaker Change: We believe a significant treatment gap remains in the anti-GD2 space in both pediatric and adult cancers.
Speaker Change: We are committed to supporting the advancement of these investigative sponsored studies through clinical development and working to unlock the untapped potential of Mecidiv-Map.
Thank you. I appreciate it. Thank you.
Let me now hand the call over to Peter Pfreundschuh.
Thank you, Vignesh, and good morning, everyone.
Speaker Change: As you heard earlier, we recorded total Daniel's Net Product Revenues of $18.5 million in the third quarter of 2024.
Speaker Change: representing a 7% decrease compared to $20.0 million total Danielsa net product revenues in the third quarter of 2023.
Speaker Change: primarily driven by decreased international and U.S. revenues from a decline in U.S. and ex-U.S. order volumes.
representing a 5% decline.
Speaker Change: The decline was primarily due to an unfavorable price mix, partially offset by increased U.S. volume of 5 percent.
Speaker Change: during the third quarter of 2024 compared to the third quarter of 2023.
Thank you.
Speaker Change: Ex-U.S. net product revenues were $3.1 million and $3.9 million for the three months ended September 30, 2024 and 2023, respectively, representing a 19% decline.
Speaker Change: The decline was primarily driven by decreased volume from Western Europe in the quarter.
Speaker Change: We received an inventory order from Cyclone of $1.7 million in the third quarter.
Speaker Change: But the revenue was recorded in the fourth quarter due to cutoff timing issues.
Speaker Change: Our total Danielza Net Product Revenues of $60.7 million for the 9 months ended September 30, 2024 were relatively flat compared to $61 million for the 9 months ended September 30, 2023.
Speaker Change: We did not have licensing revenue for the three months ended September 30, 2024. We did report 0.5 million of licensing revenue in the nine months ended September 30, 2024.
Speaker Change: We also reported $0.5 million of licensing revenue for the three and nine months ended September 30, 2023.
Speaker Change: Moving to operating expenses, our research and development expenses were $11.2 million and $36.8 million for the quarter and nine months ended September 30, 2024.
Speaker Change: representing decreases of 4.2 million and 4 million from 15.4 million and 40.8 million for the quarter and nine months ended September 30th, 2023.
Selling general and administrative expenses increased by $3.4 million.
Speaker Change: and $8.5 million to $13.6 million and $42.3 million for the three and nine months ended September 30, 2024, respectively.
compared to the same periods in 2023.
Speaker Change: The increase in selling general and administrative expenses for the three months ended September 30, 2024, was primarily attributable to a $1.2 million increase related to our former Chief Financial Officer separation and consulting agreements.
Speaker Change: and a 1.1 million increase in personnel costs inclusive of stock-based compensation and 0.5 million in professional and consulting fees.
Speaker Change: The increase to selling general and administrative expenses for the nine months ended September 30, 2024.
Speaker Change: was primarily attributable to a net impact of $3.8 million related to two legal settlements that were finalized in the nine months ended September 30, 2024.
Speaker Change: As previously mentioned, the increase also includes a $1.2 million increase related to our former Chief Financial Officer's Separation Agreement and Consulting Agreement.
Speaker Change: A $1.1 million increase in personal costs inclusive of stock-based compensation and $0.8 million in professional and consulting fees.
Speaker Change: compared to a net loss of 7.7 million for a negative 18 cents per basic and diluted share for the quarter ended September 30th, 2023.
Speaker Change: In addition, we have reported a net loss for the 9 months ended September 30, 2024 of $22.9 million or negative $0.52 per basic and diluted share as compared to a net loss of $20.4 million
Speaker Change: for a negative 47 cents per basic and diluted share for the nine months ended September 30, 2023.
Speaker Change: The decrease in net loss for the three months ended September 30th, 2024, was primarily driven by decreased operating expenses.
and a favorable impact from foreign currency transactions.
partially offset by decreased product revenues net.
Speaker Change: The increase in the net loss for the nine months ended September 30, 2024, was primarily driven by the previously mentioned two legal settlements with a net $3.8 million impact.
Speaker Change: As mentioned earlier, we ended the third quarter of 2024 with cash and cash equivalents of $68.1 million, as compared to $78.6 million at year-end 2023.
representing a decrease of 10.5 million year-to-date.
Speaker Change: Importantly, we continue to maintain a strong balance sheet, reporting $9.7 million in cash outflows for the third quarter of 2024.
Speaker Change: primarily driven by cash payments on the two previously mentioned legal settlements paid within the quarter.
Thank you. Thank you. Thank you.
Turning now to our full year 2024
Speaker Change: We reiterate our full year 2024 total net revenue guidance to be in the range between $87 and $95 million, but we expect the revenues will come in in the bottom half of that range.
Speaker Change: We continue to anticipate our operating expenses will remain in the range of between $115 and $120 million for the full year 2024, which is consistent with our prior guidance.
Speaker Change: and we expect our cash investment for the full year of 2024 to remain in the range of between 15 and 20 million dollars which is consistent with our prior guidance.
Speaker Change: With a strong balance sheet and a focused strategy, we believe YMAPS is well positioned to execute on our strategic missions and priorities and to support the delivery of multiple anticipated near-term milestones.
Speaker Change: This concludes the financial update and I will turn the call back over to Mike.
Mike Rossi: Thank you for that overview, Pete. Now let's open the line for questions.
Operator.
Thank you.
Thank you.
Speaker Change: We will now be conducting a question and answer session. If you would like to ask a question, please press star 1 on your telephone keypad.
Speaker Change: A confirmation tone will indicate your line is in the question queue.
Speaker Change: You may press star 2 if you would like to remove your question from the queue. For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys.
One moment, please, while we poll for questions.
Speaker Change: The first question is from Edzer Daru from BMO Capital Markets. Please go ahead.
Edzer Daru: Great. Thanks for taking the question. One on Danielza and another on the GD2 side. So, for Danielza, if you could talk a little bit more about the...
Edzer Daru: Price Mix Dynamic in the quarter, and is this something you expect to continue moving forward and what are the potential offsets?
Edzer Daru: in the fourth quarter, and then on GD2-SADA, you have, you know, no dose-limiting talks, dose correlating to preclinical data. If you could talk through maybe the key criteria for dose selection for sort of the Part D of the study. Thanks.
Edzer Daru: for the antibodies specifically, the dose for the antibodies specifically. Thanks.
Speaker Change: Director, thank you very much for that. I'll pass the first question on regarding the price mix to Sue and then bring it back for the
Thanks Mike, thanks for the question.
Sue Smith: So, we took an approximate $1.5 million charge in Q3 for Medicaid-related claims, for both period and out of the period, and so due to that price mix, we saw a 5% decline in net revenues, even in spite of having a 5% increase in vials.
Sue Smith: And so with the adjustment, the sales would have been up 4% for both year-over-year and quarter-over-quarter.
Thank you, Sue.
Speaker Change: So the the second question you had is around the protein, the optimal protein dose on our GD2-SATA. So what we've done so far through the first six cohorts is we started at the 0.3 milligram per kilogram, escalated up to
Speaker Change: three milligram per kilogram and have since backed that down to one milligram per kilogram shortening the window and looking at an optimized window, so
Speaker Change: To move that into Part B, for us it was nearing more of the preclinical PK data that we saw.
looking at the blood levels, understanding we want a dose.
Speaker Change: near the nadir, and what we've seen so far with that is allowing us to then focus on the one milligram per kilogram and feel very confident that we're narrowing that down.
Speaker Change: So, Vignesh, anything additional to that? Just to build on that, obviously we need to evaluate the dosimetry in the tumor as well as in normal tissues, and of course the safety. All of this will contribute to the evaluation of the optimal dose and the dose interval.
Great, thank you.
Thank you, Ezra.
Speaker Change: The next question is from Lee Wacek from Cantor. Please go ahead.
and many more. Thank you. Thank you.
Okay, good morning. Thanks for taking our questions.
Speaker Change: I guess if you can comment on some of the swing factors for Q4 revenues as we're heading into the holidays.
Speaker Change: your confidence level of hitting the lower end of the guide.
Speaker Change: And the second question is just for GD2 SELDA, you're looking at a number of histology, so wondering if you can comment on the radiosensitivity of these tumor types.
and many more. Thank you. Thank you.
Speaker Change: All right, thank you, Lee. For the fourth quarter guidance, I'll pass you to Pete, and I'll allow Pete to expand on that.
Pete Pfreundschuh: Well Lee, thanks for the question. With regards to the guidance, we feel very confident that we should land within the range of 87 to 95 million dollars. We did highlight for you as part of the earnings call that we should most probably land in the lower half of that range.
If you look at the third quarter results...
Pete Pfreundschuh: We did highlight for you that the Cyclone Belle did land in the fourth quarter.
So with the Cyclone Sail adjustment, with the Medicaid adjustment,
and then also the NOVL, or the timing of the...
Pete Pfreundschuh: We most probably would have landed, actually, based upon the consensus numbers,
Pete Pfreundschuh: just about where the consensus numbers were for the third quarter.
Pete Pfreundschuh: So for the fourth quarter, we still anticipate a very strong quarter, and we anticipate to land somewhere in the lower half of basically the guidance range as we laid out for you guys between $87 and $95 million. Hopefully that helps you lead.
Speaker Change: And Lee, your second question around the GD2 SADA and the radio sensitivity, I'll pass that on to Vignesh.
Vignesh Rajah: Thank you. So just to remind everybody, the cancer that we have included in the 1001 study include osteosarcoma, melanoma, soft tissue sarcoma, small cell lung cancer, and in the latest cohort we added adult neuroblastoma.
Vignesh Rajah: It's too soon to say what we've seen in terms of early indicators of sensitivity to radiation. As you know, the GD2 expression levels is quite heterogeneous in these solid tumors. The variations within the tumor, as well as antigen density, hence the rationale to include also adult neuroblastoma patients.
Vignesh Rajah: So as we get more data on the evaluation of dissymmetry and responses, we'll update the group here in terms of what we've seen in terms of radiation sensitivity.
Okay, great. Thank you.
Thank you for watching. For more information, visit www.fema.gov.
Speaker Change: and many more. Thank you for watching. I hope you enjoyed this video. If you did, please click the Like button and subscribe to my channel. I will see you in the next video.
Speaker Change: The next question is from Alec Stranahan from Bank of America. Please go ahead.
Speaker Change: Hey guys, thanks for taking our questions, just two from us.
Speaker Change: First, with moving your headquarters early next year, I'm curious to hear the latest on your approach to manufacturing and whether you'll be making additional investments here as well.
Speaker Change: And then on the New Deal in Japan, maybe outline how you see the commercial rollout going there and sort of the incremental TAM that Japan represents for Danielta. Thank you.
Speaker Change: Thanks Alex. You know our philosophy on manufacturing hasn't changed. We're in a unique position with both Daniels and our SADA platform that the way our current structure is we're able to use contract manufacturing for proteins
Speaker Change: which allow us to, rather than invest in brick and mortar, allows us to invest in the drugs themselves. And similar on the SADA platform, we're able to use the same network that we have for our SADA protein constructs.
Speaker Change: and contract directly with isotope manufacturers for the production and caging of isotopes.
Speaker Change: So we're doing additional work with our proprietary chelators as we're looking to expand within the alpha and beta space, as well as the PET, that allow us then, rather than, again,
investing in manufacturing, really invest in drug development.
Speaker Change: I think that the second point, as we look at Japan...
Speaker Change: We've got a small clinical trial to do within Japan and that'll be limited to six patients to confirm similar to what we've done in the U.S. in order to get that rolled out. So we expect to kick that off rather shortly and increase the overall
Speaker Change: ability to launch that product hopefully in the second half of 25 to early 26.
Speaker Change: So, as we move forward on that, as we look at the total addressable market, Japan is a significant healthcare market, but overall, it's
Speaker Change: It is a much smaller market than the U.S., and we'd expect to see incremental from that, but not necessarily a very large expansion of our total addressable market.
Thank you. Thank you. Thank you.
and many more. Thank you. Thank you.
That's about it. Thanks.
Thanks, Alex.
Thank you.
Speaker Change: The next question is from Justin Walsh from Jones Trading. Please go ahead.
Justin Walsh: Thanks for taking the question. I'm curious what your thoughts are on the increasing numbers of players testing pre-targeting approaches and
Justin Walsh: I'm specifically thinking about some pre-clinical data on another approach being tested by Roche and Aranamed that was at EANM adding to the groups that we're already following. So do you think that this like provides additional validation for or confidence in what you're already trying to accomplish with the SADA?
Speaker Change: That's a good question Justin. I think as we look at this, any time you see more and more companies coming into it
It does validate.
Bob.
Speaker Change: what the theory is around providing maximum dose to the tumor, minimum off-target, and more importantly providing better logistics to get into shorter-lived isotopes.
Speaker Change: So, you know, we welcome this from an intellectual point of view as well. The more smart people and smart companies you have working on this.
Speaker Change: And again, what's extremely important about that as well is leveraging the existing infrastructure.
Speaker Change: to get more patients treated without having to go to specific diagnostic suites.
So we welcome that opportunity, I think there's...
Speaker Change: a variety of methods in which to do this and time will tell which is
Speaker Change: optimal, which is right, and there are always more than one right answer, so we wish the others, you know,
much success as they move forward.
Speaker Change: It really allows us then to focus on what we can do well and what we will do well for the patients and practitioners.
Great, thanks for taking the question.
Thank you.
Speaker Change: The next question is from Mike Ilts from Morgan Stanley. Please go ahead.
Speaker Change: Hi, good morning. This is Rohit An from Mike. Thanks for taking our questions. Just going back to 3Q Danielle Cecil, how much of the decline would you contribute to seasonality, competitors, and the ongoing clinical trials? And I think you mentioned something on a change in estimate for Medicaid claims for the quarter. Can you just elaborate on that? Thank you.
Speaker Change: Thank you, thank you very much. You know, I guess we'll start backwards on this and I'll pass it over to Pete to talk a little bit about what the Medicare looks like.
Speaker Change: what the changes are there, and then we'll move over to Sue to talk a little bit about the volume and what we see as impacting that as well as potentially
What the good news is in the way of volume.
Speaker Change: So good question. With regards to the Medicaid element of the sales mix for the US
Speaker Change: The reality is the number of sites that we're selling into that have Medicaid, 340K, is continuing to increase a bit more relative to sites that have less of that presence in those sites.
Speaker Change: And so, as we got into the third quarter, we had an adjustment that was associated with both in-quarter as well as previous quarter coming into this.
Speaker Change: And so to that note, there was about a $1.5 million push down that we had to take in the quarter relative to that.
So overall, we did report about $15.3 million.
With the 1-5, we're at about 16-8.
Speaker Change: One thing that we did not really get into was there was also some timing related issues specifically in shipments also.
within quarter that
Speaker Change: Slipped into the fourth quarter. That was about another seven hundred thousand dollars And so when you actually compare kind of where we were a year ago third quarter at 16-1 with those adjustments we would have landed somewhere around 17-5
Speaker Change: And so, actually, our sales overall is kind of up, and that kind of correlates, as you saw.
We did have volume increases for the quarter.
Speaker Change: You know, again, there were some timing-related things that fell in quarter that impacted us, but for the most part, it continues to reinforce our confidence with regards to kind of where the marks are.
Sue Smith: where Daniela is. So then I'll pass it over to Sue for a little bit more color here. Okay. Thanks, Steve.
Thanks Mike for the question.
Sue Smith: Yeah, I think, obviously, you know, our mix continues to be about 80-20 with U.S. being about 80% of our volume. And we have, on all indicators, key performance indicators grown quarter over quarter in terms of the number of physicians treating, the number of patients starts.
number of physicians with two or more patients.
Sue Smith: and notably, the majority of our sales is coming from high volume centers.
Sue Smith: where our market share is higher than if you look at all centers together.
Sue Smith: And that, we believe, is really coming because of our new competitive campaign, which is enabling us to really talk about differentiating our core value in being able to still attain a complete response, even in heavily pre-treated patients, and even in patients who are no longer responding to or have developed antibodies to prior anti-GD2 therapy. So that is certainly how we're going after market share of Unitoxin. And we also, as we've mentioned, see volume in the fourth quarter coming from China due to the timing of that large shipment that Pete talked about.
Sue Smith: Thank you for watching. I'm Susan Smith. Have a great day.
Thanks, Sue. Thanks, Pete.
Speaker Change: The next question is, pardon me, as a reminder to ask a question please press star 1.
Speaker Change: The next question is from Jeff Jones from Oppenheimer. Please go ahead.
Jeff Jones: Good morning guys and thanks for taking the question. Two from us, one on Danielle and one on Sada.
Jeff Jones: With respect to Cash Runway, which you projected into 2027, can you highlight what studies and work is included in there amongst
Jeff Jones: Danielza, and SADA. And then for the SADA platform specifically, when might we hear more detail around future plans, targets, target selection, and indication? Thanks.
Thank you. Thank you.
Speaker Change: Thank you, Jeff. I'll pass the first part of your question on to Pete for Cache Runway and what we have planned and kind of how we're looking at that.
Yeah, Jeff, good question.
Pete Pfreundschuh: Previous quarters we communicated that we have runway into 2027. We've reiterated that as part of this quarter as well.
Pete Pfreundschuh: Again, I would first start with our cash investment or burn for this year.
Pete Pfreundschuh: on a net basis relative to kind of where we set out guidance.
Pete Pfreundschuh: Our guidance is $15 to $20 million of investment this year over and above the proceeds cash inflows from Danielza.
Pete Pfreundschuh: What we're seeing to date, and we issued that as part of this earnings release, is we're slightly over $10 million a year to date on that number. We do have some favorable things coming in now as part of the fourth quarter. We mentioned the noble licensing deal, that $2 million is coming in.
Pete Pfreundschuh: alongside some other things. So we're well on track to the lower end of that 15 to 20 million dollar range is kind of what we're anticipating for this year.
Pete Pfreundschuh: That should land us kind of in the low 60s, most probably somewhere 60 to 65. I would skew more to the 65 number.
Pete Pfreundschuh: And then kind of as we go forward, what are anticipated views around both investment and return on Danielza was that Danielza would continue to see some mild growth, call it single digits to maybe a low double-digit number.
Pete Pfreundschuh: In either view, we get good cash flows off of Danielza moving forward over the next number of years.
Pete Pfreundschuh: And then on the investment side of the equation, we anticipated that we would be investing in new SADA programs.
Pete Pfreundschuh: at least one or two every year. So that was kind of the thought process as we laid it out.
Speaker Change: As is the case, Jeff, most companies are going through kind of a revised operating plan cycle at this time of year.
Speaker Change: When we issue our 10Ks in March, we'll issue new guidance for not only 2025, but also give you guys an update as to our thoughts around investment moving forward. So hopefully that helps you.
Speaker Change: Yeah, and Jeff, as a follow-up to the second part of the question, we're actually right now in that process of evaluating a multitude of targets and narrowing them down to targets that really
Speaker Change: fit what we're doing here at YMAPS. So, we're in that process, and I would say in the early part of 2025, most likely
Speaker Change: First quarter, you'll see a revised priority list as well as specific timelines and what exactly we are going to be targeting moving forward. And as Pete discussed, we have plans to
invest in several targets and bring several programs per year.
Speaker Change: into the clinic. So stay tuned for that but that that will happen in early 25s.
Great. Appreciate that. Thanks, guys.
That's all. Thank you.
Speaker Change: The next question is from David Nierengarten from Wedbush Securities. Please go ahead.
David Nierengarten: Thanks for taking my question. I was just wondering if you could tell us on your...
David Nierengarten: dose escalation and kind of push or pull back, I'm going to call it back to one milligram. Is there any, Prasada, sorry,
David Nierengarten: Is there any differences in tumor types that drove that, or tumor burden, or was it just timing and pKa, like, I don't know if you could walk us through without, you know, giving us the data too early on, you know, kind of what was, what you were seeing that
David Nierengarten: drove you to decide or look at a dose level. Thanks.
Thank you. Thank you. Thank you.
Speaker Change: Yeah, David, that was a great question. We'll give you much more of that detail once we release it, but I'll give you the top line on this. We've talked about this in the past.
Speaker Change: What we need to do with the radiopharmaceuticals in a pre-targeting is paint the tumor and to cover those receptors without putting so much in the blood that we're taking a long time to clear it out. So we know the disassembly of SADA is concentration dependent. So when we model the pre-clinical data based on the mouse model.
One milligram was the target based on that.
Speaker Change: We had the flexibility to go up to ten times higher than that and started at one-third of that. But the reality was we started at one-third looking at it from a safety perspective, brought it through the one milligram and then 3x that at the three milligrams.
Speaker Change: and the PK was modeling what we saw in the preclinical so it made sense for us to bring it back to that target level rather than go higher and extend the time in which we would wait.
Speaker Change: for the isotope. So now it's just fine-tuning that back in. It had nothing to do with tumor types. It had nothing to do with
Speaker Change: being that the PK levels were modeling that of the preclinical data.
Speaker Change: that we narrow that down as a variable and bring it back into that range and start shortening the window, again, changing one variable at a time. So we feel very good about where that is. And again, it had nothing to do with any toxicity or anything else. It was really
Speaker Change: feeling that we had enough protein to paint the tumor and clear it quickly enough from the bloodstream.
Thanks.
Thanks, David.
Speaker Change: The next question is from Nicole Germino from Truist Securities. Please go ahead.
Speaker Change: Good morning, thanks for taking my question. I have two on SATA. The first one, can you just talk a little bit more about the dosimetry in which organs do you expect the drug to accumulate and more, and what are the acceptable lutetium levels in kidney and liver?
Thank you.
Speaker Change: Yeah, Nicole, that's a great question. I think when we look at this and understanding that both the SADA as well as
Speaker Change: The Lutetia and DOTA are renally eliminated. We would expect to see, as far as off-tumor, for the kidneys and the bladder, to be...
Speaker Change: The second would be any kind of liver uptake or bone marrow. We're evaluating all of that as part of the clinical trial since, again, this is the first in human. But I'm not...
right now.
Speaker Change: We don't have any data to share on those and what they look like, and Vignesh, I don't know if there's anything from your side that you want to discuss as what our limits we're looking at as far as what we're trying to maintain below.
Speaker Change: I think we can, and we've already shared this with you, in terms of the safety margins.
Speaker Change: So far we've not seen any early indications of any safety issues, no dose-limiting toxicities or treatment-related serious adverse events, but further evaluation will go on and we'll share with you more results as we get through soon.
Speaker Change: Okay, great. And then one quick question on your targets. Can you elaborate more on your target selection strategy and what are the parameters for how you're choosing your target priorities?
Speaker Change: Yeah, we're working through that right now. We'll lay that out as part of the the total strategy. It's not something we're ready to disclose at this point as we're walking through the list, but we are looking at many receptor modulated diseases. We're looking at unmet need as well as commercial potential.
So, there is a significant amount of...
Speaker Change: criteria we're putting into this and this will be a living document for us. As we move forward and bring targets into the clinic, we'll be looking at the next five to ten targets.
Speaker Change: how they are positioned both clinically and commercially at that point in time and can reprioritize as we move forward. So there are several criteria and we'll outline that as we bring this entire strategy forward.
Great, thank you.
Speaker Change: This concludes the question and answer session. I would like to turn the floor back over to Michael Rossi for closing comments.
and many more. Thank you. Thank you.
Speaker Change: Great. Thank you everyone for joining us today to discuss our third quarter results and continued progress.
Speaker Change: We have a strong financial foundation and continue to believe we are uniquely positioned for future growth while advancing the clinical development of our differentiated radioimmune therapy platform, SADAPRIT.
Speaker Change: to potentially deliver better and safer therapeutic options in the treatment of a number of serious diseases with unmet needs. We look forward to seeing many of you at upcoming investor meetings and medical meetings throughout the winter. If we didn't get to your question and you have additional questions, we're happy to schedule time with individual investors and answer those questions at that point in time.
Thank you and have a great day.
Speaker Change: This concludes today's teleconference. You may disconnect your lines at this time. Thank you for your participation.
and many more. Thank you. Thank you.
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