Q3 2022 Bioatla Inc Earnings Call
Good day and welcome to the bio Alt at third quarter 2022 earnings conference call.
Pardon me.
Atlanta.
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Note. This event is being recorded I would now like to turn the conference over to Bruce Michael from Life Science Advisors.
Please go ahead.
Thank you operator, and good afternoon, everyone with me today on the phone from bio Attila, our Doctor Jay short Chairman CEO and cofounder Scott Smith President.
Martin Chief of clinical development and operations.
Jerry <unk> senior Vice President commercial strategy, and Richard Waldron, Chief Financial Officer.
Before we begin I'd like to remind everyone that statements made during this conference call will include forward looking statements, including but not limited to statements regarding bio Atlas business plans and prospects potential selective licensing collaborations and other strategic partnerships.
Whether our clinical trials will be potentially registrational.
Result, conduct progress and timing of our research and development programs and clinical trials.
Spectation with respect to enrollment and dosing in clinical trials.
Plans regarding future data updates.
Clinical trials regulatory meetings and regulatory submissions the potential regulatory approval path for our product candidates X.
Expectations about the sufficiency of our cash and cash equivalents and expected R&D and G&A expenses.
These statements are subject to various risks assumptions and uncertainties that can cause actual results to differ materially and are described in the filings made with the SEC, including the most recent quarterly report on Form 10-Q.
You are cautioned not to place undue reliance on these forward looking statements, which speak only as of today November 3rd 2022, and bio attalid disclaims any obligation to update such statements reflect future information.
Vince or circumstances, except as required by law.
With that I'd like to turn the call over to J short J.
Thank you Bruce Thanks to everyone for joining us for a third quarter of 2022.
Earnings call.
We continue the positive trajectory for advancing the development of innovative critical of preclinical programs available by the broad applicability of bio Atlas cab technology.
The third quarter was marked by continued strong execution with promising results across our five ongoing phase two trials for an hour or two later stage cab ADC product candidates B E 301, more and be a 3021 across multiple solid tumor types for these first in class therapeutic candidates.
Additionally, we are excited with the continued to antitumor activity and lack of disease progression.
Along with multiple partial responses.
As we continue to enroll additional patients that RBA 3011 phase two non small cell lung cancer study as well as recent feedback from the F. D. A for from our proposed path forward for the a 3011 phase two Sarcomas study.
But before I go any further I would like to remind everyone that additional details related to what we're going to Brazil.
[noise] available on our web site is part of our updated company presentation that may be helpful to you.
We previously shared interim data on our B, a 3011 phase III Sarcomas study.
And there'll be a 3011 phase two non small cell lung cancer study and we now look forward to providing additional insights on both.
On today's call, we will discuss additional updates for other.
Other clinical programs.
<unk> 021 studies continue to progress and we anticipate enrollment completion of up to 20 patients that are non small cell lung cancer study by year end for reporting in January or validated liquid biopsy assay in the middle of the other things being implemented using our I'll say before your air.
In addition, our head Mech study is ongoing and we anticipate dosing multiple patients by year end.
Phase one two basket trial for a cab.
A four antibody B E 3071 is progressing nicely with the first two cohorts completed and the third cohort of expected by year end.
We also received encouraging pre imd's feedback from the F. D. A four hour dual cab by specific T cell engaged or antibody.
Cam C D three or B E 3182, and remain on track for the foreign IMD submission of the fourth quarter of this year.
<unk>, we remain on track with IMD submissions for up to two next generation cap candidates next year. We are pleased with our cumulative results that continued to support both the preliminary efficacy and safety from our differentiated proprietary cab platform. Thus far in 2022, and we are well poised to continue with strong.
Execution.
We have several additional upcoming catalysts as well as important results to be covered in today's discussion, including exciting updates from our phase III Sarcomas study as well as updates from our phase two non small cell lung cancer study with our lead asset C. A 3011.
With that I would now like to turn the call over to Italy for additional details clearly.
Thank you J and good afternoon, everyone I.
I would like to start by providing an update on our phase two study Nonsmall said lung cancer with our Capex away D. C. B a 3011.
As a reminder, one of a phase two study not small cell lung cancer. He is ongoing and Axel positive patients who have previously expat experience failure of P. D. One egfr are out can you Peter therapy.
As of October we have an all 24 patients of these patients 14, or if he could see valuable space.
Patients had failed on average three private lines of systemic therapies.
13 patient I'd failed a P D one inhibitor and one that failed.
Far inhibitors.
These 14 patients are composed of 12, non squamous and two squamous cell carcinoma of patients.
Regarding non squamous patients eight of 12 were administered B, a Tuesday with one one mono therapy and for 12 received B E 3011 in combination with a P. D. One inhibitor.
Matt.
And non squamous patients we have observed to date.
For a partial responses O P r's and the mono therapy group group.
Representing an objective response rate or or or a 50 per cent.
And P. D. One failure patients you or are in non squamous patience is 57 per cent.
And the combination group, we have we have observed one complete response or C. R for an hour of 25 per cent.
Cause it was a <unk> remain consistent with a preliminary data are reported last quarter and confirms the iffy cause he's signal observed in phase one.
Of the tree variable squamous cell carcinoma patience, no new patient wearing all this quarter and we have not yet observed a response any subtype.
All patients enrolled actual positive with a T M. P S of 1% or more the rate of actual positivity and then not smell set on cancer population continues to be high we estimated to be approximately 35% for the non squamous population in approximately 30% for the squamous population based on over 200.
Small cell lung cancer tumor samples tested so far for excellent expression.
That's what the latest safety data cut.
The safety enter everyday T profile from the face to another small cell lung cancer study continues to be differentiated from other it made me 86 and one of the.
[noise] opinion in combination with me voting map no new signals have been identified from phase one no treatment related deaths and few great three or four as were reported.
To put these data into perspective, and notwithstanding the relatively small sample size of our dataset.
If he could see observed in this study in this study in particular.
[noise] observed for the Tuesday, with one one mono therapy non squamous group is highly competitive any speeding wine refractory population and supportive of moving forward to potentially a registration British attritional part of this study.
As of data cut off we have an old twenty-four patience, which will allow us to perform an interim analysis by ear and in the meantime, we continuously animal patient in fact, one to help us better define which population in which treatment cohort of cohorts will be advancing to the potentially registrational part of the study.
Moving on to South Carolina.
Previously, we presenting an interim data both our phase one an ongoing one of the phase two trial of the a 3711.
In fact, one we found that U P S and it'll stay with Sakuma subtypes responded to be a Teresa one one which provided the rationale for moving forward into part two of.
Of this study based on predefined Eternal go no go criteria of either at least one partial response or complete response per step type or a progression free or P. A first rate of at least 40 per cent of three months.
During our call last quarter, we shared data from additional cohorts, where we observed the P. A first rate of 60% in LIBOR sarcoma.
It'd be a first rate of 50 per cent is you know a real sucker him out and a P. A first rate of 67% and they'll steal a sucker.
All three subtypes exceeded our predefined go criteria to part two faced to.
To date, we continue to see see me to a slightly improve PFS rate in all three sarcoma subtypes and I'm very encouraged that all three subtests continue to meet are pretty fun go criteria to advancing to part two of the face to study.
Where we got to the safety profile across sarcoma subtypes B a trace of one one continues to be generally well tolerated with a face to safety profile cause she stuck with a profile observed in phase one.
That's communicated previously.
We had asked F D. A for reading feedback on our proposed Registrational plans in your P. S. Written feedback was received in October and we are pleased with the F. D. A response to the proposed study design in particular the.
The agency was not opposed to the selection of subjective response rate or R. As the primary endpoint in they spoke duration.
Oh with initially proceeding with a total sample size of 80 patient and I'd minor comments regarding our inclusion exclusion criteria.
If the year was also supportive of including a more intensive dozing arm as part of this study based on the street and feedback from the agency and a compelling profile observed B 83011, and they spoke relation we believe we have a path for it to advance B at 301 went toward registration and U P. S.
We are currently finalizing the protocol following the agency's feedback and plan to start though think patient by the end of this year.
Additionally, we plan on moving forward that additional suck on my subtypes as part of a label the expansion strategy. Following da Teresa one won approval in U P. S.
I'd like to thank you for your attention and she everyone that highlight the significant unmet medical need and commercial opportunity and U P S and non small cell lung cancer.
Sure.
For me and good afternoon and everything.
But the data today and I think to check on the study the F. D. A guidance received medical need an undifferentiated pay and my tech sarcoma or U P. S.
Excited too quickly in pursuit of I'm eating indications of <unk> [noise].
U P S as long as Elijah stuck on the subtype, representing nearly 15 per cent of all Sir what's your second name.
<unk> no it's depressing sometimes.
<unk>.
There are currently no at the treatments physically parents to Chi EPS patients tend to progress very rapidly.
In addition exercises D V D right and UPN, that's quite high at around 80 per cent and they asked me approximately 3000 to 4000 exercise within that dress up address up on EPS patients per year in the U S alone.
Adding in Europe interest in World and number of addressable G. P. S patients who could potentially benefit can be 301 line exceeds 10000 per year.
Asked me to be a worldwide commercial opportunity at approximately 750 million at peak.
<unk> EPS represents a salad initial indications of bio at that as we speak to transition into a commercial stage biotech company.
Especially based on data.
<unk>.
I bet, you need chips, and our label and footprint to include Osteosarcoma sniper sarcoma, nobody else dark on that and perhaps other stuff on the subtypes.
Ultimately be a Tuesday, or one line has the potential to treat 25000, plus connotations per year in January up to 2 billion in revenue worldwide area, a very high on medical need.
Furthermore, we continued to be enthusiastic by the responses might have to do anything with the 3019 and my pleasure factory non small cell lung cancer.
And unlimited treatment options for these patients who progressed enemy checkpoint inhibitors and available treatments and a second line and began setting had set optima overall objective response rate of approximately 10% to 20%.
With respect to market size, a significant proportion of non small cell lung patients Express XO and we estimate that there are approximately 40 to 50000 <unk> patients per year in the U S and over 100000 per year worldwide.
This second line plus indication has the potential to add approximately two and a half to 3 billion in wildlife revenue at peak.
The fact that we continue to see anti tumor activity and non small cell out as being real more patience is very encouraging and based on preliminary internal observation. We believe b E 3011 will be highly commercially relevant with an O. R. R. Well a bus carrying O R is absurd and a multi refractory piece.
<unk> population.
Taken together sarcoma, and non small cell lung cancer, and we believe B E 2011 has the potential to become a significant commercial asset for bio at lax across multiple solid tumor types.
Of even greater importance is that B E 3011 has the potential to be a best in class treatment for a significant number of patients who fail multiple lines of therapy.
Feeling a significant unmet medical needs.
No I would like to turn the call over to Scott Smith, President Violet light to provide an overview and updates to our ongoing clinical programs Scott.
[noise], Thank you Sherry and good afternoon.
Before I review, our key operational updates from quarter I Wanna share my excitement around our lead asset B E 3011 with updates on part one in the phase two non small cell lung cancer study and the proposed path forward and soft tissue sarcoma, specifically UBS.
First and non small cell lung, we're thrilled with continued responses were observing hasn't been enroll additional patients as of data cut off we have enrolled 24 patients 14, which are efficacy valuable we continue to see responses and both mono therapy and combination therapy with memorial a map and non scientists.
Non small cell lung with four out of eight partial responses mono therapy and once you complete response uninformed patients combination.
These responses are quite remarkable, especially in this multi refractory patient population, we anticipate a full insurance dataset of approximately 20 patients through multiple scans by the end of this year, we will wait for the full interim data analysis before making detailed feature studied determination, but we were thrilled to see compelling entered tumor.
Antitumor activity, thus far with 3011 in both mono therapy and in combination with me though.
Moving onto U P S.
At least noted we're very pleased to be moving in the park to the study and potentially Registrational portion of the trial. We are currently finalizing the protocol and anticipate studied enrollment in doses will commence by year end.
And Additionally, UBS, we continue to see positive antitumor activity across several soft tissue and bone sarcoma subtypes, we've already exceeded our internal dose criteria for osteosarcoma microsecond, but since I know, you'll sarcoma and continue to enroll other sarcoma sometimes.
In terms of our overall sarcoma strategy. We are initially focused on UBS with an opportunity to expand our label to include other sarcoma, sometimes should we obtain approval and you'd be S. U.
<unk> represents a significant commercial opportunity a standalone indication however, given the encouraging antitumor activity were observed in other subtypes, coupled with a significant unmet medical need we see real value potentially expanding our sarcoma footprint overtime.
Now turning to our second lead cab ADC product candidate B E 3021, a cab or to a D C.
As a reminder, there are no other therapies targeting <unk> declining so we have the potential to have a first class treatment for solid tumors.
If there is one we saw impressive responses and <unk> positive patients refractory repeating one therapy, including GPRS non small cell lung, one PR and hadn't met cancer and complete response melanoma patients who remains to complete remission off treatment for over two years.
To date, we have three phase two trials on July 3021, and I'm happy to provide an update as to where we are with each beginning with non small cell lung.
The non small cell lung traveling refractory patients as long as planned and currently dosing the interim update of the preliminary cohort about 20 patients falling at least three months of therapy anticipated the beginning of next year.
Turning to the melanoma trial, which is being conducted in patients refractory to P. D. One therapy noninvasive liberal by a biopsy assay has been validated and we anticipate initiating screening with this assay by the end of the year. We remain very excited about the potential of 3021, a melanoma patients, particularly.
With the potential acceleration of enrollment foaming full implementation of the liquid.
I see.
The third phase two study we've initiated with 3021 is in refractory patients with head and neck cancer.
This study continues to enroll is actively screening patients.
We anticipate multiple patients stove new year and.
To round out our cab UDC programs, we're supporting a multicenter investigated initiated phase two clinical trial 301143021 in patients with platinum resistance.
Cancer to date, a total of 10 patients had been dose five in each program.
This trial is ongoing and we will provide an update as one becomes available to us.
Now I'd like to talk briefly about updates for <unk> for anybody being a 3071.
This phase one two trial has been conducted in tumors known to be responsible for treatment and will evaluate safety and tolerability of 3071 in mono therapy and in combination with mobile now.
This trials progressing as planned with the first two cohorts completed without any dlp's or S E as reported.
Third cohort, which is that a dose equivalent to be approved those women that is ongoing with the DLC observation period anticipated to conclude by year end.
Turning to our preclinical pipeline.
Have several candidates and I envy, enabling faith then include God by specifics second generation ADC anybody's regarding our tab at camp Cab C. D. Three by specific B 3182, we received written pre pre Ivy feedback from the F. D. A that are preclinical package.
Adequate to move forward.
And we will remain on track by Andy submission by the end of this year.
We also remain on track for potential near term I need submissions from preclinical next generation job candidates and two and 2023 and beyond.
With that I'd like to hand, it over to <unk> to review the third quarter 2022 financials.
Thank you Scott.
As of September 30th 2022, we had 178.1 million in cash and cash equivalents compared to $245 million.
The 31st 2021.
We expect current cash and cash equivalents will be sufficient unplanned operations, including all ongoing cab product development programs into second half 2024.
As a reminder, we control all cab product market rights and the U S Europe and Japan.
This strategy includes advancing commercial preparation and key global markets.
While exploring opportunities to extend our cats runaway by generating upfront cash as selective licensing a product rights.
Certain territories.
Collaboration with other biopharmaceutical company that could also provide to us development milestones and royalties upon regulatory approval and commercialization.
And create additional value to stockholders.
For the third quarter ended September 30th 2022.
He reported a net loss of $25.8 million compared to a net loss of $22.9 million.
And the same core of 2021.
Research and development expenses were 19.8 million for the quarter ended September 30th 2022.
Compared to 16.6 million for the same quarter in 2021.
The increase of 3.2 million was primarily driven by our clinical product development efforts.
We expect our R&D expenses to remain variable from quarter to quarter and generally increase as we continue to invest in R&D activities to advance our product candidates in a clinical programs.
General and administrative expenses were $6.3 million for the quarter ended September 30, 2022, compared to $7.1 million, but the same quarter in 2021.
The 800000 dollar change was attributable to a decrease in stock based compensation because of 2022 period.
We expect a genie expenses too moderately increased to support development of our product candidates.
[noise] advance on intellectual property portfolio support Precommercialization activities for our product, Canada, B E 3011, and satisfy requirements as a public company.
Net cash used an operating activities for the nine months ended September 30th 2022 was $66.1 million compared to net cash using operating activities of $41.3 million for the same period in 2021.
The increase in net cash used them operating activities for the first nine months of 2022.
Primarily due to an increase in research and development expense.
To our program development efforts as compared to the first nine months of 2021.
And now back to Scott.
Thank you Rick.
We are very pleased with the progress we have made this quarter across the portfolio. We're excited with compelling clinical profile that is beginning to emerge in treatment refractory non small cell lung cancer interview here too advanced into the potentially registrational part of the cities to study and U P. S.
Also remain encouraged continued execution around our other promising tab assets and multiple cancer indications.
We are well poised to reach several valued pretty milestones.
With their innovative cab assets and remain enthusiastic about the future.
<unk>, we will continue to have strong focus and execution with the goal of pursuing indications of high unmet medical need that we feel will have significant impact for patients.
Shareholders worldwide.
With that we will now turn back to the operator and take your questions.
Thank you.
We will now begin the question and answer session.
Ooh.
Ask a question you May press star one on your Touchtone phone.
If you are using a speaker phone please pick up your handset before pressing the keys.
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At this time.
Pause momentarily to assemble our roster.
Our first question comes from Brian Chang.
J P. Morgan Brian . Please go ahead.
Hi, I'm glad I found the progress and thanks for taking my question.
Can you provide some color on that time to respond then ability.
<unk> in a class F 14 patients.
Or actual positive asks yahtzee.
And then I have one follow up on UPN [noise].
[noise]. Thank you Bryan and thank you for the question.
Yep. Thank you Brian .
I will ask the lead to give some color around your your your two parts of your first question around.
The time to respond and also initial thoughts on durability, although I would say it is awfully early for us and we're starting to be able to be to have any definitive view on on duration of durability at this point that Felipe.
[noise] yeah. Thanks, Scott. So we saw response as early as I was first Ah cycle January responsibility bears observe that sort of cycle or worse or second cycle.
<unk> I'm, sorry, a second scan and that's what I'm interested in a circumstance skin is at six weeks.
And we don't got to durability.
<unk> <unk> early for us to give you a number but the patients have been responding I'd been on treatment as as long as.
Nine cycles, so about nine months on treatments and we're so far we're not seeing a problem with <unk>.
Great.
And then on the U P. S. <unk> you know that is that there is a more intensive dosing arm that your plan for <unk> for the U P. S side I thought that the response that you had previously what's already pretty competitive.
So I'm wondering if you can shed some light on you know why there isn't a additional more intense that's the only thing arm what is important that that's the other thing I'm in is it more of or I try and exercise to see if you can get a better response. Thank you [noise].
Yes. Thank you very much for the question Bryan yet we have seen if we combine.
Phase, one and fees to U P. S. Patience, we're seeing a 50% response rate, which is very very high in this particular population Ah.
<unk> very difficult disease very difficult to get.
Under control and so this high intensity is just exploratory and see if we can get even better efficacy. We will also have an arm at the current 1.8.
I was particularly ma'am dose that will move forward and after we have an initial balls of patience, we will choose one of those two arms to move forward. So overall I think it's a very positive signal.
The safety and Tolerability that we hadn't seen so far allows us to try a more intensive arm. If we don't see good benefit risk coming in and that will go to the card. So I think overall very positive development.
Alright, Thanks God. Thank you [noise].
Our next question comes from Kelly She's from Geoffrey.
<unk>.
Please go ahead.
Congrats on the great progress and thank you for taking my question insofar suddenly.
So far the time do you fall patients, who you roll it out into the non smoking on lung cancer I'll call her to foster a 011.
And how many outside the 10 patient advocacy.
Africa valuable actually not smell I mean, now goodness and Y Shirley sat down next data I think.
And I also do you do you intend to lie in Rome, all patients beyond their Sunday for a patient and I also have follow up.
[noise]. Thank you very much for the question. So yes, we have actually email the the 20th locations with the data could awesome.
October we have now enrolled 2070 patients we expect to make our decisions on how to structure part two of the study and and make our decisions on how to approach the agency. The F. D. A <unk> based on the boards of 20 patients valuable through through multiple scams.
So, but we do under the protocol have an opportunity to look up to 40 patients and there are some questions still outstanding and we'd like to answer around squamish versus non swine that's monotherapy versus.
Mono therapy versus combination.
Therapy et cetera. So we will continue to enroll some more patience with the initial cohort that we are going to use to make the <unk>.
Is 20 patient yourself of the additional patients who have not yet gone through multiple scams that are on the side.
I believe they're all mountain Chihuahuas I don't know personally the all 27 to 24 I believe they're all moms gas stations.
So let's add any direction.
No that that that is correct and to answer your first question.
12, <unk> out of the 14, if you can see evaluable patients were non squamous patience, we still have two squamous patience is that the same patients.
We had talked about during the last update we've not animal would mean squamous patient.
Great. Thanks, and also for that you can.
[noise].
Can you actually tell <unk> share more details regarding after your feedback and also small color registration no child design.
Yes, Thanks, UBS, Kelly and definitely do you want to talk a little bit about a little bit more contacts on the written a response from the F. D. A in the design moving forward.
Yeah. So we we sent a proposal to a D. A for the registration part of the study Ah D. A.
We asked.
Asked for.
Oh R. R. As the primary endpoint. We also last four is sympathize of 80 patients and also asked for including the more intensive building arm, which yeah no objections to we the study design is.
And 140 gigabyte dosing one on and then the more intensive busy in another randomizing patience 20 in each of these two arms.
And then we'll make a decision on which of these two do as we go forward with them and then add an additional 40 patients after that so that the registration or those will have 60 patients total.
Super helpful. Congrats again.
Okay.
Thank you Kelly.
Our next question is coming from.
Butler from Roth Capital Tony. Please go ahead.
Thanks very much.
I continue to be impressed with the non small cell lung cancer.
Especially in those.
Previous pretty one.
Part, two where I believe last quarter, you made comments that you'd like to enroll 100 patients.
Jesse today or anything to do with that that.
That in fact could be registration number one that's true.
Could it could the trial actually.
Would it be a trial with out of control group.
Do you think that it would include monotherapy combo at least within those 100 patient smugglers 50 50.
Question, one and number two.
Correct or do I remember correctly, maybe that's a better way to put it on the 20% response rate.
And and S. Yeltsin.
Commercially relevant for 31, thank you.
[noise] yeah. So thank you very much for the questions here. So you know the the design with any of our queue. Here is obviously contingent and subject to discussion with the with the F. D. A you know I believe there is a path and some precedent and this and this multi refractory P. D. One failure.
Mon population.
To be able to do a single line or our study.
I'm not able to determine at this point in time, whether we mean, just the mono therapy arm or the amount of one combo arms forward. We wanted to we wanted to preserve the rights collect a little bit more data.
To be able to to assess that more properly but.
What's wrong with the response ready to see it so I think a great sign that we're seeing significant efficacy and mono therapy as we have gone from the the cutesy me to the country disclosure, we maintain 50 per cent response rate in the in the non slanderous monotherapy arm 57 per cent. If you just look at the P. D. One failure.
Population there. So you know very very strong data you know based on our.
Internal discussions and thoughts before the study started we believe it again this multi refractory England failure population that are 20% Oh, our our way could be legislation of course pending review and benefit risk and some of those things we thought the 25 and above would be commercially viable that's important to know.
The actual positive.
Group of <unk> patients quite large trending in between 35 and 40 per cent of the of the refractory population and so you know being able to get to those response rates are above 25 per cent and this large population I think you'll be highly commercially viable for us.
I appreciate that and May I ask one follow up there.
We don't have a waterfall puppet you would have a view about this from.
Subsequent scans at least overtime.
Ah responses or do you have patients were responses deepen.
Uhm overtime.
I think generally the pattern impasse stations has for their responses to deepen overtime I think we've talked about for example, the complete response patient partial response first can I complete response.
Can scan most of the patients that we have seen in phase one and phase two.
<unk> continued deepening responds overtime. So late you want to put any more color on them.
Mmm no. Thank you you've answered the question Scott.
Richie patient depend.
Depending their response Everytime I think that's that's what we've seen in phase one.
And send me, but we're starting to see here in phase two.
[laughter].
Scott sleep. Thank you.
Thank you Tony.
And <unk>.
[noise], we have a question from Arthur Hey from H C Wayne right.
Please go ahead.
Hey, good afternoon, everyone. Congrats on the data has been confirmed.
The video for it'd be 33 11.
Regarding the announcements lung cancer trial, I, just wonder what the Ah.
Redfin temptation how.
How many patients monotherapy compared to the company.
Oh. Thank you for the question Arthur I believe as we go from there.
To the 24 I believe that the distribution of modern one combo is relatively even between mono.
Two groups yes.
So it will start to catch up and see some more combination patients coming out of it maybe just a little worried if I can be.
Earlier.
But we should see some more combinations combination patients coming in which we're excited about because not only machine complete response, there, but we would also like to have more data to fully evaluate the you know the rest of the benefits of the combination aren't so thanks for the question.
Gotcha that makes sense.
And.
For the for the for the 30 21 program regarding the non smoking and lung cancer enrollment.
Could you give us an update on regarding the status and.
Currently how many active site.
So I'll, let her sleep in a minute answer.
The the active sites in the U S. I don't have the number exactly.
With me, but I will say that the the more to loan program is probably three to four months behind where we are with with the actual program started later an accident.
He used to be that way.
We are seeing a reasonable enrollment I would expect to have a good group of patients.
For us to take a look at by the time, we get to you and we want this year and we wanted to get through multiple scan. So you know I think right now the timing that we're looking at to talk about that data set is likely Q.
Q1, 2023, whether you know during the actual quarter of the Q1 call, but I had been Q1 2023 events.
We have enough patients through multiple scans to be able to really understand that data and like I say going well I think the execution of that study probably three to four months behind wherever you move back so.
Felipe any any thoughts on the exact number of sites.
Yeah, we have approximately 35 sites mmm created.
Some of these sites are in Hong Kong and Taiwan.
Mmm vast majority about 30 of them are in the U S. So in the process nobody shooting sites.
Europe .
Receive approval to do that across the number of countries. So.
So you currently 35, but he will continue to grow.
Oh, Thanks, if I if I can I just raise one last question for the.
At 11.
Got it guys.
The correlation between the.
[noise] expression with the.
Activity one struggle.
So I think.
If we're talking about the.
The sarcoma program for 3011 or the actual ADC, we definitely see a relationship and.
Saw the relationship relatively early and today is one.
Do you start conversations have heavy.
<unk> and it seems like you need high levels of Axel expression I E over 50 per cent to really move the needle now and sarcoma, it's very bimodal patience either expressive Ah in a very small degree or none at all or at a very large room, it's not a lot of middle ground, there, but we see your relationship to natural especially especially in response.
It's four sarcoma for long.
A little bit different it's probably too early for me to make any definitive statement on the relationship between expression in response.
We are we are C responders at lower levels of actual discretion in non smartphone and high level. So I would like to gather some more data I'd like to get this next 6000 patients through multiple skiing, let's take a look at that for 20 patient subset of make some determinations relative to actual especially the response, but it does look.
Different than.
Then we saw a circle.
Got it. Thanks, Thanks, Thanks, Scott and again congrats on the on Prozac talk to you soon.
Thank you very much.
I would like to remind you if you would like to pose the question Press Star then one R.
Our next question comes from hand, Benjamin from J M P security.
<unk>. Please go ahead.
Thanks, Good afternoon guys.
It's taken a question rats on the progress.
To start off with you know Vietnam Evaluable patients that you have so far can you just tell me how many are.
Rug.
As of as of now it seems like several maybe just don't have scans yet.
Can you give us the breakdown of that and can you also just remind us that if all the responses to date have been confirmed.
Finally are there any learnings that you have been able to ascertain from the Nonresponders that might help you to further define an exclusion criteria.
So so.
To answer your last question first I don't know that we have.
Really defines.
Learning from the Nonresponders I know from a couple of more responders. They were more heavily pre treated in sales more prior lines therapy than others. So that seems to be a trend which continues.
In terms of a confirmation so of the five patients that responded before partial responses incompleteness box three of those are confirmed to have come in more recently and they have not had seconds Canyon someone's those second skins come in in the remaining we will confirm.
The the trend has been for patients do respond early continued to improve response so.
Our hope is that those two will be confirmed but they just haven't been confirm yet because they haven't had a second scan and.
The first question you ask them so I.
Write that down that's okay, sorry, I, probably shouldn't have asked all three at once.
Yes.
Just the non Evaluable patients are are they are they still on drugs I I.
I couldn't do the math.
24 World, They're 14 advocacy I think you know 10 or not a valuable but there there might be a further breakdown.
Yes, you know I believe the majority of those easily again can breakdown members source. The majority of those the large majority of our patients that are just not have not had scans are not had <unk>.
Saturday on drug use a coupla aren't that I believe that sleep jewelry addresses.
Yeah, So 24 patient and will 14, if you can see that.
The 10 difference is that we had six patients that are currently ongoing being treated but haven't reached their first scan and we add two patients at time of data cut off that we're not dose yet and we had the <unk> early which the same patient we mentioned that the last.
Quite a nicole.
That's the breakdown for this supposed to send patients.
Perfect sexually and just one final one for us.
As I evaluate the combo data you know.
The response rates.
Can you help maybe define what what are we.
At what point do you kind of cut bank.
India evaluate different.
Checkpoint or a different company.
Yeah, I think it's it's it's hard for me to answer that question of exact numbers I think what you Wanna see in general you Wanna see something emerging from that that is better than what you've seen from a dragon mono therapy, you want to see a better benefit risk emerged emerging or there's no sense going in combo investors.
A subset of patients who are more likely to benefit from combination.
I think what we're seeing in combination therapy has made me more of an artifact of numbers and that's why we're really excited to get some more some more combination patients tend to see what's going on there if you'd.
You'd like to see.
Africa C at or above what you're seeing a monotherapy and not significant added in Texas.
Overall, what we're looking for so we have not given up on the the combo arm by any means.
Before patients that we do have a complete response, we have two patients who went out of the study because of toxicity that I believe I was.
For it is related to the bowling Ah Ah So Ah.
Members, let's get another 456 at the temptation from that arm when we can take a look and see what's there, but you know what is really sort of heartening to us is that.
You see for any patient and monotherapy responding those patients all all all five patients have responded here are still unresponsive maintenance study, which is very very encouraging as well and you know the drug certainly seems to be accurate mono therapy, and we got a little more work to do and a few more patience and the combination decided to make a final.
Termination there.
Perfect. Thanks, very much for taking the questions and congrats.
Thank you.
And this concludes our question and answer session.
Would like now to turn the conference back over to Scott Smith, President of bio Adler for any closing remarks.
Yeah, just to thank you all very much for your time and attention. We're really proud of the progress. We've made not only you know from Q2 Q3, but this whole year, you're starting to office.
A tough year for political development from the overcrowding COVID-19 perspective, but.
You know we were mediated.
Piece of political developments going very well the results are going very well you know more than anything I think when we take a look at the at the safety and efficacy data benefit restaurants emergency here at least for 30 for 30, 11th because.
We've got enough patience to make US assessment, you really see soon to see the technology cleanup clinic.
You see side effect profile.
Which is very much in line with this idea of using technology to greatly eliminate or two to actually really reduce or eliminate.
On target of tumor toxicity and eliminate some of that baggage that you get with my cancer gyms mature very promising but also existing unhealthy tissues. While also received the kind of technology.
Technology and move forward in the clinic the executions vanilla, we're really excited.
Added about moving 30 11 in the two into.
Potential.
Registration was studying UBS moving forward into part two of the longest studies, we're really excited about next year as well with where to data coming CTO for data coming from the phase one to study there and also we should be bringing a cabinet came capp C. Three by specific into the clinic by the end of this year and start doesn't that next year. So.
We should have the four candidates in the clinic.
Next year, and Proximately 10 cancer indications and we're really excited not just about 301, which we're very excited about it but the whole portfolio going forward. So thank you all very much for your for your time and attention.
France has now concluded. Thank you for attending today's presentation you may now disconnect.