Q3 2023 Y-mAbs Therapeutics Inc Earnings Call
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Good morning, and welcome to why Moms Therapeutics third quarter 2023 earnings Conference call. Please note that today's event.
Good.
At this time all participants are in a listen only mode.
That's for the question and answer session will follow the prepared remarks.
I'd now like to turn the conference call over to Courtney Dugan, Vice President Investor Relations. Please go ahead.
Thank you operator, and good morning, everyone.
Welcome to our third quarter 'twenty eight 'twenty three.
We issued a press release with our results yesterday, because the press release that the company.
Our 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 by.
Litigation Reform Act.
Got it.
Such statements include but are not limited to statements about our business.
Yeah.
The product distribution and brand.
Expectations with respect to relate trial that.
Current and future clinical and preclinical studies in our research and development programs.
Expectations related to the timing of initiation and completion of a regulatory submission regulatory marketing and reimbursement approval, including statements with respect to future development or other TV programs.
Potential Virginia territory expansion.
That collaboration or strategic partnership and the potential benefits.
Expectations related we're anticipating.
The efficiency of our cash resources and assumptions related thereto Guy.
Guidance and expectations for 'twenty and beyond.
Performance.
And our estimates regarding revenues expenses and capital expenditure requirements.
Another thing.
Okay.
Because forward looking statements involve risks and uncertainties are not guarantees of future potential 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.
Camber, 13th 2023 and filed with the SEC.
Great.
I would now like to turn the call over to our founder and Vice Chairman of the board of Directors and Chief business Officer.
Yeah.
Thank you Courtney and good morning, everybody and thank you for joining us today.
I have with me today are Chief Financial Officer, Bo Kruse, our Chief commercial Officer Sue Smith.
Our chief scientific did see I think.
Officer, Dr stainless Pete.
I'm also very excited to welcome our newly appointed President and Chief Executive Officer, Michael Rossi.
On today's call Mike will begin by reviewing third quarter Global highlight something you also sales.
Updates on all I'm going to sit them about clinical trials and high level updates around all sort of program.
Then report further insights into our U S and you also sales into third quarter.
Next thing will provide further details on all phase one TD to start a trial currently underway. In addition to updates on our CD 38 sort of program for which we recently received IND clearance by the U S. F D. A.
And then bill will provide an overview of our third quarter financial performance our cash resources.
And on a full year 2023 guidance before we open the lines for Q&A.
Before we get into the third quarter, we sold.
On behalf of the Wimax 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 six.
Our board is conducting a careful search for the right dedicated lead all of our companies with deep commercial and radiopharmaceutical experienced and we are very pleased to have found that and Mike.
<unk> brings over 30 years of experience in the radiopharmaceutical industry. He joins us from Miriam technologies, where he served as the president of the medical group.
Prior to that Mike was the head of radio ligand imaging and advanced accelerator applications pending known as AAA and Novartis company and before that he left the growth of jubilant Gray with <unk> radio.
And so our vertical integrated radiopharmaceutical lead them.
Earlier in his career, Mike spent over a decade of G health care and he's also certified nuclear pharmacist.
As we continue our efforts to expand the geographic reach of 10 year old son, and fair, though indication expansion initiatives to maximize the utility of this therapy.
I'm also incredibly excited about a novel Tuesday at pre target radio immunotherapy platform.
None of us saw that.
And its potential to unlock the value of Radiopharmaceuticals and the cancer treatment paradigm.
After a re org in the first quarter of this year.
It's been persistent that's one of the few independent commercial stage biotech companies.
Sufficient financial resources to advance sada through proof of concept.
Is this 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 Wimax team continued.
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 and it's great to be joining you all today for Wimax third quarter earnings call.
As Thomas mentioned I built a 30 plus year career in health care with a specific focus on radiopharmaceuticals.
IMAX is a pioneer in pre targeted radio immune therapy with the Sada technology platform, which is a key driver of my own personal excitement about joining wipe apps.
<unk> stands out as a highly differentiated pre targeted two step platform, but it is designed to enable precise radioisotope delivery.
I truly believe that sort of has the potential to shift the treatment paradigm and radiotherapy.
In addition, we have the promising Danielle the franchise, where we expect to have a growing stream of revenue with our commercial product Danielle.
Dependent we support our clinical development work with <unk> and a rapidly expanding radio pharma market.
With our phase <unk> trial underway.
Pays one CD 38 sort of 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.
The key highlights for the quarter starting with Daniels.
As a reminder, Danielle was approved by the U S. FDA for the treatment of relapsed or refractory high risk neuroblastoma in the bone or bone marrow are 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 and net product sales of Danielle.
Up 59% from what we recorded in the third quarter of 2022.
We continue to make significant progress in our commercialization efforts for Danielle.
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 daniels's launch with 90, new accounts so far in 2023.
We continue to expand our global commercial footprint through partnerships and recently received regulatory approval of the Daniels in Mexico.
Marking our second regulatory approval in Latin America with our partner.
In addition, as discussed last quarter.
Our partner Cyclone successfully announced launch Daniels 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 50% of the vials used in the U S. During the quarter.
Well, 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 Danielle.
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 Daniels that through the end of Q3.
The continued geographic expansion of Danielle so across these regions is an important step in our mission to enable broad global access for Daniels for patients with high risk refract relapsed refractory neuroblastoma.
We remain encouraged by the expansion of Daniels.
Accumulating global net sales of more than $61 million in the first nine months of 2023 as we continued to gain further traction with physicians prescribing Daniels.
We remain confident in our ability to continue to expand our global commercial market footprint and meet our full year 2000 2020.
2023, Daniels that net product revenue guidance of between 80 and $85 million.
Sue will provide further color I've Daniels of sales in the quarter shortly.
No.
Let me briefly comment on our ongoing cinemark 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 Danielle.
And the frontline high risk neuroblastoma, setting we are partnering with the beat childhood cancer Research consortium.
Or B C C and multicenter phase two trial.
Valuation in excess of the Mab in combination with standard induction therapy for patients with newly diagnosed high risk neuroblastoma.
To date nine sites have been initiated and six patients had been dosed. The study is expected to transition from a single arm study with an exit of Mab added to the current standard treatment for induction to a randomized study where the control arm will be the current standard of care production therapy, which is chemotherapy plus.
Minus an alpha inhibitor for.
For which we plan to file in IMD.
As a reminder, the patient recruitment for the trial as projected.
Span of five years with an anticipated total trial sample size of approximately 282 patients.
Our aim for the trial is to demonstrate the superiority of an accident.
Arm versus standard of care.
We expect to potentially initiate the new randomized study in the second quarter of next year.
And obviously you start calling on we're continuing to work with Memorial Sloan Kettering Cancer Center or M. S. K.
Multicenter investigator sponsored trial for next at a minimum.
We anticipate M S K to provide a data readout from this phase one two trial.
In fourth quarter of 2024, and if positive we hope to then begin recruitment for our pivotal randomized phase III trial.
In addition, we are pleased with the publication of the study or exit a map based chemo immunotherapy hits trial in patients with chemo resistant high risk neuroblastoma in the journal cancers.
In this trial patients who receive kits immediately after induction had a higher response rates.
47% versus 18%.
Here your 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 support the utilization of an exit of Mad early during the course of treatment for patients with chemo resistant high risk neuroblastoma.
We are continuing to work to unlock further value of next set of Mad 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 <unk>.
Our novel product technology platform is a key driver in my own personal excitement about joining why maps.
Throw my extensive career in various radio form of leadership roles I've had the privilege to witness the development of numerous breakthrough technological platforms.
However, sada, which is licensed by wine nabs from SK, 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 saw that has a potential to shift the radiotherapy treatment paradigm.
And potentially be impactful in the fight against the wide variety of cancers.
Steve will provide further color on our specific platforms later in todays call well, let me provide a high level overview of where we currently are with our solid pipeline.
Our first program G D. Tucson began phase one development earlier this year to date, we have completed dosing cohorts cohorts, one and two currently administering doses in cohort three.
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 a proof of concept for our sada platform. During this call.
The progress we're seeing we have elected to focus on a more mature phase one data readout at a major medical meeting next year in lieu of an R&D day event in December.
Our second program CD 38.
Recently received IND clearance from the U S FDA to enter clinical development.
We're particularly excited about the program given our teams deep CD 38 targeted drug development experience.
We anticipate exploring potential partnership opportunities as this program advances.
The phase one dose escalation open label single arm Multicenter trial evaluating the safety and Tolerability of CD 38 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 are both b cell and T cell, Oregon, and we look forward to providing further updates as our program advances.
In addition, we are continuing to advance multiple preclinical Sato targets and have made encouraging progress, especially on our hurt too and be seven H three contracts.
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.
It was 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 Daniels of sales growth, which serves as the financial foundation to propel our Sada technology through clinical development with our two lead programs.
We believe we're in a great position to bring forward additional novel Therapeutics for cancer patients, who need them, while at the same time delivering long term value to shareholders.
I am thrilled to be here at Wimax. 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. Daniels's sales in further detail shortly.
Thank you, Mike and good morning, everyone I'm pleased to be with the commercial to share the commercial progress with Daniels than in the U S. We increased Danielle just sales, 59% year over year compared to the third quarter of last year.
The uneven and as from a quarter over quarter standpoint, this is not surprising and rare disease indications, particularly considering the ultra rare indication of Daniels huh.
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 he had toxin was at three year post launch, 45% versus 22% growth and we believe we have room for continued growth.
As Mike mentioned, we recorded 61 million in Daniels of 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 and Danielle the sales I.
Let me review key highlights from Daniels and 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 has launched 258.
We continue to grow outside of M. S. K with non M. S. K vials sold representing 63% of all Daniels of demand in the U S. During the third quarter.
With 57 accounts now having used daniels that 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 daniels out with 36 health care providers, having prescribed Daniels that in the first nine months of this year, including seven HCP, starting two or more patients in the first nine months of this year.
Since launch a total of 88 doctors have prescribed Danielle <unk>.
In 28 of them have started treatment on two or more patients as of September 30th 2023.
Our U S. Commercial sales team has received increasingly positive HCP feedback on Daniels that to over 2500 customer interactions in the first nine months of this year.
Over 6400 interactions since our launch in 2021.
We also continue to see institutional adoption of Daniel's that which is that which has been added to five hospital formularies in the first nine months of this year, bringing the total since launch to 41 hospital formulary.
My Mom's remains a leader in the U S. Anti GDT market are highly important area of pediatric cancer in a rare disease market with a flat incidence rate.
Looking ahead to the fourth quarter 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 Daniels's campaign.
The new campaign Repossessions and elaborates on Daniels is differentiating characteristics in the treatment of high risk neuroblastoma for patients who have experienced incomplete response to induction therapy and they're buying in the bone marrow.
Utilizing our Prespecified interim analysis data, which was consistent with our label.
He campaign enables us to share our data for refractory versus relapse patients separately, providing more detailed data regarding daniels's performance in patients with an incomplete response response to induction therapy and also patients who are relapsed, which are two different patient groups.
In addition, it demonstrates daniels's response in children after prior anti <unk> therapy.
I'm very proud of this team they have been hard at work and the preparation and rollout of the new campaign.
<unk> two 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 the scheme, who will discuss the latest progress of our Sada platform in further detail.
Okay.
Thank you Sue and good morning, everyone I'm pleased to provide you with an update on our solar programs beginning with <unk>.
Our phase one trial evaluating the safety and Tolerability of TD Tucson electric <unk> positive solid tumors.
<unk> small cell lung cancer cohorts and.
And our Noma cutaway in March of this year.
This phase one dose escalation Simplon multi center phase two study has three parts.
Part a is supposed to dose finding off the sada molecule itself and trusting that those intervals.
So two five days between the protein administration and the.
Lutetium total payout.
He wanted to determine the optimal dose and to teach them to Wichita, and patchy evaluation of safety and neutral signs of efficacy using repeat dosing.
Dose escalation is based on.
Two patients in cohorts, one and two followed by a modified three question Hassan.
And it's important to emphasize that each cohort patient when you strip out the dosing and the so called switch so slimming Jean.
Type C such periods of PMT.
Currently we are still in part D and the trial is progression.
Well, we have those high patients in the fourth quarter and at present, we have six active sites three sites are expected to be activated to any cost.
We have advanced through the first two cohorts and allowed those places in coffee.
We now have more patients receive either to Huntington.
They were supposed to have a kitchen total.
I would like to emphasize that we are still in putting this trial, which is central to investigate the safety profile of the total and just your chairman I've seen the planning Minister debating okay.
Okay.
Yeah.
We have options with what we assume.
So huh.
No patient has experienced any dose limiting toxicities to date.
Oh, no patients have experienced any related severe enrichment or serious adverse events.
And of note, we can dose oral potent windows.
Serious pain sequence detectors.
Today, We also plan to answer is believed to have demonstrated proof of concept.
Tucson, but demonstrating that the sort of multi choice can find and binds to tumors and that's a radionuclide targets, especially your lives on these fixed she just glancing at home.
It's important to note that these early data are not complete and are not necessarily indicative of the full resolves all ultimate success off its highs all solid tumor program.
As seen on the next.
Next slide.
We got an opinion that the exposure of the proxy to expose them to patients looked as expected.
And if they think they would fall patients in each of the two treatment groups. So eight patients until now.
The patient dose the <unk> three milligrams per kilogram protein represents Shia in blue and the patient dose was appointed me to FEMSA programs represent a hint payable are comparable and support the dose into closer to two five things is being used so far.
Next slide we for the first time, a Shang is spec C T scan demonstrating tumor uptake in one patient.
This patient this scandalous conducted after an imaging dose of 30 milligrams.
Yeah, we've got very harsh on the data so far and based on this we investigated the potential clinical expansion to saddle into P. J I took developing next year.
You also please tell us how long do you get to start up on its progression and you call. It to Shang selection o'clock pace anticipated next year at a medical meeting with Josh.
Okay.
In addition, as Mike mentioned earlier, we are also excited by the snakes, yes, Uh-huh D. Our CD 38 sort of program in Hodgkin lymphoma publishing and Bruce B and T cell lymphomas and expect to dose the first patient in this phase one time next year.
Now with the addition of the CD 38, Sarah we have reached the clinic at William face O S auto platform in both solid and Hematological tumors.
We do believe in the potential for the novel decided to acknowledge a pet home two becomes a targeted radiopharmaceuticals deliver pet home of choice in the future.
The truth, the Chinchilla, I'm, saying the treatment landscape across a variety of cancers.
And I'll now hand, the call over to Bob Cushing Who'll review, our financials for the third quarter.
Yeah.
Thank you Stan and good morning, everyone.
Net product revenues of 61 million for the nine months ended September 30th 'twenty to 'twenty three represented an increase of 86% from $32 8 million reported for the nine months ended September 32.
2022.
Increase of $28 2 million was primarily driven by an increase in new U S patients and that included some benefit from expanding international revenues.
I went to Nielsen net product revenues of 20 million in the third quarter of 2023.
Representing 59% increase compared to the third quarter was 22, and a marginal decline compared to the second quarter of 'twenty three as we saw some unevenness in international revenues. After a series of inventory stocking orders from our International partners has reported in recent quarters.
During the three and nine months ended September 30th 2023 we recorded half a million of license revenue in accordance with our suppliers and sub licensing agreement with ADM. Following the achievement of the marketing authorization for that in Youngstown in Mexico in September.
Now moving to operating expenses, our R&D expenses decreased by $7 1 billion I'm, sorry, two 1 million to $15 four and $40 8 million for the three and nine months ended September 32020 free respectively compared to the same periods in 'twenty two.
The net decrease was primarily due to the decrease in spending on de prioritized 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 the crude time based clinical milestones related to our sard technology.
Okay.
Selling general and administrative expenses decreased by $3 4 million and 16 point Paul.
<unk> million to $10 2 million and $33 7 million for the three and nine months ended September 30th 2023, respectively compared to the same periods in 2022 the decrease in SG&A for the three months ended September 30 is 2023 was primarily driven by cost savings in connection with our.
<unk> claim.
Greece and G&A for the nine months ended September 30th 2023 was primarily attributable to a $10 $9 million charge related to the departure of our former CEO in Q2, 2022 and so let's say extend it at $2 9 million total deep.
Kris and commercialization expenses incurred in 'twenty 'twenty chew in Mtc.
In anticipation of a potential brought them at launch.
Additionally, we recorded a restructuring charge of $1 1 million in SG&A. During the nine months ended September 30th 2022 three in.
In connection with the restructuring plan, however personnel related costs inclusive of stock based compensation actually decrease in the three and nine months ended September 30 is 22, you see 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 is 2023 of $7 7 million or 18 cents.
Basic and diluted compared to a net loss.
27, and a half million dollars or 63 cents per share basic and diluted for the third quarter ended September 30 is 2022.
The improvement in our net loss was primarily driven by the increased revenues and the gross often coupled with decreased operating expenses in the third quarter of 2023. Additionally, we reported a net loss for the nine months ended September 32023 of $20 4 million.
A 47 cents per share basic and diluted compared to a net loss of $96 7 million or.
Two doors in 'twenty, one cents per share basic and diluted for the nine months ended September 30 is 2022.
The decrease in net loss was primarily driven by higher product revenues and 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 and Q2 2022.
Okay.
As mentioned earlier, we ended the third quarter 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 reduced our quarterly cashews from $4 7 million to $1 3 million or about 72% during the third quarter of 'twenty to 'twenty three compared to the second quarter.
We continue to.
So demonstrate responsible.
Cost management, along with margin expansion for 10 years, and we believe we're in position to reduce our projected full year 2023 operating expenses ranged from $115 million to $120 million, So I'm granted $215 million, which took.
With working capital adjustment leads to a reduction of total expected cash burn range for the full year 'twenty 'twenty free from $40 million to $50 million to 27 to 32 million.
The sequential impact on all of it.
Expected cash runway isn't that we now believe our cash and cash equivalents were sufficiently support our commercial operations and pipeline programs as currently planned into 2027.
We continue to expect full year 'twenty 'twenty free then you'll see that net revenues to be in the range of $80 million to $85 million.
As we noted in prior quarters, the underlying assumptions for this guidance important to understand no new partnerships or the new business development income is included in the assumptions for the purpose of this analysis of runway only.
<unk> product revenues are assumed to increase by 10% each year from 24 through 26.
We indeed hope to see higher growth rates with any of them 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 reimbursement program has been assumed for the purpose of this estimate and we have not assumed any equity offerings of borrowings.
We believe <unk> remains well positioned to execute our strategic mission priorities to support to deliver flexible.
Yes.
This concludes the financial update and I'll now turn it.
Back to Mike.
Thank you for that overview both.
Now, let's open the line for questions operator, do you have any questions.
Thank you we will now be conducting a question and answer session. If you would like to ask a question. Please press star one on your telephone keypad, a confirmation tone will indicate your line is in the question queue. You May press star two if he would like to remove your question from thank you for participating.
Excuse me speaker equipment, it may be necessary to pick up your handset before pressing the star one.
One moment, please while we poll for questions.
Our first question comes from Alec Stranahan from Bank of America. Please proceed.
Hey, guys. Thanks for taking our question just a couple from US Firstly, you know I think sue outline some changes in the commercialization strategy for Daniels.
And I know, Mike you, probably still settling into the role but any.
What would you say, it's the single biggest lever that you could pull to help drive growth for Danielle.
And.
How does that compare to the 10% year over year growth that that though outlined and then I've got a follow up.
Well I. Thank you for your question I will pass that to Sue.
We have a robust plan for our expansion of Daniela.
In the best position to to discuss that Sue.
Thanks, Mike Thanks, Alex for your question.
There are a couple of really important levers that we're able to pull with this campaign.
It actually parses out our efficacy data in frontline.
Patients who are on the frontline.
Partial response to induction.
This is consistent with our label, but are currently will blended in a relapsed and refractory data together by our ability to parse out the efficacy.
We are able to demonstrate that a patient who has an incomplete response to induction still can have a 46% response.
Right.
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.
Third line treatment setting after relapse. So this is a significant movement in opportunity and we also are excited because we have new data that shows our benefit after failing prior anti <unk> therapy another important.
When you think of me.
Toxin users, we still have a 31% response rate after prior anti G D to 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, Thanks for that.
Just one follow up on <unk>.
38, Sada as you've been thinking about pushing that's one into the clinic has there been any lessons learned from Gd to saada.
Dosing or.
Design of the molecule or the clinical study.
Yeah, Alex I appreciate the question on that I'm going to pass it over to Steve.
You can discuss what.
We've learned from Judy too as we move forward next year to CD 38.
Okay.
Thank you.
I think what we've learned so far is I always want alluded to earlier is that it's until now it has been quite safe to amusement and say this is how the program and it's at a protein in particular.
So we have no serious adverse events related to the protein that we should know.
Great.
Plus our adverse events related to the protein and I think that is something that we bring it to the next program and when we discuss starting dose Austin chalk well.
We also use of course always finished with the non clinical tox package to bring though which was she gets her the eight program and we were happy that D. C has accepted that program and now we have to have an open mind.
So I think we are more confident administering the sada protein to use now and wherewithal and as such we hope to a little bit more quick dose escalation in the first part of the trial.
Thank you. Thank you Steve next question operator.
Okay.
Our next question comes from Charles Zhou from Guggenheim. Please proceed.
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 sort of platform on that note regarding the GT two sort of given your intent to put out a more substantial data readout, if I heard that correctly in the 2020 for medical meeting as opposed to the yearend.
R&D day.
What quantity as well as types of data could you potentially percent could we for example, see things like additional whole body planar images or Oregon in tumor 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 him to Steve to discuss what information potentially will be available and what we expect to be able to present at a medical meeting this that's coming here.
Thank you so for the time to take hold and we still are in the early part of the human dose escalation study. So that's just a safety study as discussed at the time.
But definitely we know already asked this question of dose and nine patients and we continue enrollment so.
So we would be able to share those.
The PK data distribution data as an initial all what's the tumor imaging, which we shot the first picture with you today. So that these kind of information will be ready to be shot at doing in the next year.
Thank you Frank.
Right.
Yeah, and if I could squeeze in no one for a follow up on that if you don't mind so.
Looking at some of the.
The initial data that you presented so far on the GPU side, and maybe something a little bit more grant granular, but noticed that your PK data appears to be on the injected protein concentration, but just also how any color you can provide on radio isotope uptake into the tumor upon you know the 200 mill Billie Korea.
The administration. Thank you.
Thank you Charles.
And this is early days and it's as discussed we have more patients now receive me the two into military.
Most of the tumor uptake and the bio distribution of data is collected on the 30 <unk>. It does seem that you dose, but we also are planning to ensure the scans after the therapeutic dose going forward. So so for now it looks fine we are still looking for scalability off superb.
Dose escalate if I'm correct, one bureaucrat only so we are still continuing the dose escalation of potent protein. So I think we need to wait more robust protein data before we did.
Joseph discusses my talking too.
Excellent. Thanks for taking the questions and definitely look forward to that readout next year.
Very good next question operator.
Our next question comes from Belo Morgan from Canaccord Genuity. Please proceed.
Hey, good morning, and welcome Mike.
Two questions from me when you cite the 57 accounts for Daniels is that all.
Have written and currently set up to Ray Daniels.
Or is there sort of a time cut off just to 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 G. D to targeting to the CD 38 targeting are there any unique challenges to targeting CD 38 versus <unk> two that might prevent a seamless read through from that data.
Thank you.
Okay.
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 or Danielle.
Alright. 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 152 accounts I've ever used any anti <unk> therapy. So we're well on our way to over a third of those accounts.
Who are using Daniels and.
As we mentioned before we were seeing deeper penetration of those accounts and also the repeat use oh in 'twenty two accounts with two or more patients were also seeing an increase in the tier one accounts. So so where we're making good headway from a breadth and depth standpoint.
And bill as far as your second question goes on the G. D. Two versus CD 38, Oh, I'm going to pass that to Steve, but understanding that our team has a very deep domain knowledge and CD 38, which actually it makes it very interesting for us moving forward and being able to to target. The C. D 30.
Eight.
Receptor so Steve.
Yeah. Thank you, yes, there are some differences between the two costs that go into the CD 38, we are entering the hematological space and of course with the Tusa procedure. We also need to make sure that we don't have too much bone marrow involvement which is.
It's part of the protocol development that we have some limits on how much bone marrow involvement the patient can have you know.
Often up to.
Portrayed the acuity directly on the many touch so much so that 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.
And reaching those areas as compared to 72 months, we've seen that with you too.
Okay very good. Thank you. Thank you for your questions. So operator next question.
Our next question comes from at first arose from BMO capital markets. Please proceed.
Great. Thanks for taking question and Mike Congrats on the role here.
Just one quick question for me going back to sort of the some of the comments in the 10-Q around the the interval of dosing of two to five days four for JD to something 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 potentially the part D expansion. Thank you.
Okay. Thank you for your call your question and I will pass that Christine has he doesn't drive any of the work on the yeah.
Okay.
Thank you Mike So I think it's too early to say what you could see on the on this the curves I shared with you earlier on this call. There was a slight shift to the right and you get went up in the protein concentration so likely that dose interval will be longer than the two days depending on how high.
They tend to stop the coaching and then if the safety precautions. So so we will have to wait until we see the Ian 10 milligrams.
Cohorts to see how would you talk PK behaves and this will also together with the absorption into the tumor cell bio distribution tumor to symmetry will dictate the sweet spot where we're the best at.
The best relationships in the Creek, a drop in the spot and term uptake would be bound so for now at least we can say that we make it worse is it good because if you're in the early part of the trial, but likely it could be longer than two days.
Great. Thank you.
Okay.
Next question operator.
Yeah.
Okay.
Our next question comes from Mike <unk> from Morgan Stanley. Please proceed.
Good morning.
And thanks for taking the question.
Maybe just a follow up on the start a program.
You're in the process of advancing the CD 38 program, but just curious thinking about advancing some of those earlier programs such as the her two program.
And will you be waiting to see more of insured data from from G D to potentially before deciding to advance some of those programs. Thanks.
Mike I appreciate the question.
As we started looking at this we've committed to submit an IND every year.
And we are going to continue to do that in advance some of the early early programs on we're extremely confident in Nevada, 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 looked at it and selling it.
On an annual basis in order to continue to use that as the overall satisfaction.
Okay.
Great. Thank you.
Okay.
Thank you Mike next question operator.
Yeah.
Our next question comes from Robert Burns from H C. Wainwright. Please proceed.
Hey, guys congrats on the quarter and congrats Mike on your appointment as CEO, just two questions, maybe two and a half or so to say for me since the point of the Sada platform is to reduce radiation associated toxicities and naval greater doses of radiation to be received I was curious to know whether or what at what level of.
Of radiation would you start seeing those G L cheese, and toxicities that would put patients off of therapy. If you werent yet given the startup platform specifically associated with the lutetium.
I'm, sorry, I'm essentially trying to get at what what's the incremental dose level, you think you could get.
Given our base level radiation without solder.
Yeah.
Oh, Yeah, Robert Thank you for the question as we're looking at these safety studies and moving forward.
On a new platform and on specific targeting we're going to be able to to really work with these two to tell me what that response looks like and also leveling out what some of the the patient individual responses look like I'll pass at the scene for some additional color, but as we look at these are primary goal now is to.
Balancing these safety and then moved into the efficacy as we move forward with that with the clinical trials.
Okay.
Thank you Mike.
I think you are not much more to add to this because it's really it's important for us now and the potential benefit to episodic touched on you said you administers the radioactive nuclei when the majority of free protein.
Out of the system.
The Holdco is to differentiate from the one step at a radio new.
It's out there in order for us to spend all my tissue and then we receive from them how much we can add onto the too much based on that data.
Okay.
Awesome. Thank you. So I can follow up for me. So you know when we think about the CD 38 sort of specifically in the multiple myeloma contact but what are your what are you viewing it as a benchmark there you are.
Viewing the benchmark is just what darice lakes did back in the day are you looking at these new CD 38 targeted agents.
Darko fast all alpha and extra bodies CD 38.
And then are you also enabling higher darts lacks utilization in those patient populations.
Robert Thank you for your question on that and I'll pass it over to Steve for what the plans are for the phase one and as we move forward.
Okay.
So as discussed earlier on this call. We are we are starting the phase one program in non Hodgkin lymphoma, so reaction not dosing multiple myeloma mutually.
And that's in order for us to to quite quickly tweet the safety benefit of that molecule.
And I do agree that that's a lot of competition on the CD 38 molecules, but this is predominantly in Lexington, myeloma space and I think but we do have here is completely different mode of action as compared to the competitors. So I'm quite confident we will later, but without but we will initially.
To start the development plan to start the development here in the both the Beacon teaches space in non Hodgkin's lymphoma.
Awesome. Thanks, guys.
Thank you Robert.
Operator are there any other questions.
This concludes our question and answer session I would like to turn the floor back over to Mike Ross for closing comments.
Thank you operator, and thank you everyone for your participation on today's <unk> third quarter earnings call and for your continued interest in why we believe we're in a strong position as we work to deliver multiple potential value, creating milestones with our novel Sard technology, while continuing to drive adoption growth and expansion of the Daniels of franchise.
Let me say it again I'm thrilled to be part of a special company and look forward to working as one team with a patient first mindset and our mission to fight cancer. Thank.
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.
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