Q2 2023 BioAtla Inc Earnings Call
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Greetings and welcome to the bio at the second quarter 2023 earnings call.
At this time all participants are in a listen only mode.
A brief question and answer session will follow the formal presentation.
If anyone should require operator assistance during the conference. Please press star zero on your telephone keypad.
As a reminder, this conference is being recorded.
It is now my pleasure to introduce your host Mr. Bruce Michael with lifestyle advisors.
Thank you Bruce you may begin.
Thank you operator, and good afternoon, everyone with me today on the phone from bio Attila, our Doctor Jay short Chairman, CEO and co founder and Richard Waldron, Chief Financial Officer.
Following today's call Doctor, Eric Sievers, Chief Medical Officer, and Sherry Leidig, Chief Commercial officer will join Jay and Rick for a short Q&A.
Earlier this afternoon bio outlet released financial results and a business update for the second quarter ended June 30, 'twenty twenty-three a copy of the press release and corporate presentation are available on the company's website.
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 it's clinical trials will be potentially registrational.
Achievements of milestones results conduct progress and timing of its research and development programs and clinical trials.
Expectations with respect to enrollment and dosing in its clinical trials.
And expectations regarding future data updates clinical trials regulatory meetings and regulatory submissions.
The potential regulatory approval path for its product candidates expectations about the sufficiency of its 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 S. E C, including the most quarterly report on Form 10-Q.
You're cautioned not to place undue reliance on these forward looking statements, which speak only as of today August 1st 20, twenty-three and bio outlet disclaims any obligation to update such statements to reflect future information.
Hence or circumstances, except as required by law.
Is that I'd like to turn the call over to Jay short Jay.
Thank you Bruce and thanks to everyone for joining us for our second quarter 'twenty to 'twenty three Biolab <unk> earnings call.
Finally, I thought it was the inventor and leader in the development of novel therapies, using a proprietary conditionally active biologics cabs platform with improved selectivity for attacking tumor cells, while avoiding healthy cells, thereby addressing urgent unmet needs in oncology to improve patients' lives.
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We made significant progress last year across our multiple ongoing phase III trials for our two latest stage first in class Chap ADC product candidates.
A three zero 11 N V 830, 21 targeting solid tumor types with high unmet medical needs. As we are now a little over halfway through 2023, we continue our positive trajectory and remain on track to achieve our recently guided milestones out by the first quarter call in May.
We remain focused on further advancing the development of our innovative clinical programs leveraging the broad applicability of our cap technology across several clinical stage antibody types.
Including Capex and cap or two adcs.
C L. A for immuno oncology naked antibody and our first dual capped by specific I can see D. Three T cell engagement.
Additional details related to what I'm going to provide are available on our website as part of our updated company presentation that may be helpful to you.
We remain excited about our lead asset D. A three zero level for multiple indications previously we shared the encouraging partial interim data on our B a three zero 11 phase II part one sarcoma study and that would be a three zero 11 phase II part one non small cell lung cancer study.
We also shared additional insights of how we have applied the learnings from our differentiated safety data and exposure response analyses as well as our new P. S related F D a interaction.
Studied more frequent dosing testing regimens more broadly across that acetyl ADC and a war two ADC programs.
The goal of studying more frequent dosing tetsu graduates across programs just to provide data to allow us to start the study parameters that maximize the company's likelihood of success for a phase two potentially registrational studies.
A summary of our current dose regimen, which can be found at the updated corporate presentation on our website.
Let's now move to our clinical operational and financial updates for the second quarter 2023.
First we are advancing V. A three zero 11 at our ongoing sarcoma phase II studies, including a potentially registrational study in the U S. P. S.
Without specific treatments approved for U P. S Theres, a significant commercial opportunity as a stand alone indication.
We have shown strong execution and promising results with continued antitumor activity.
<unk> of disease progression and a differentiated safety profile will be a three zero 11 N P. S to date.
Based on these results together with the continued differentiated safety profile and encouraging feedback from the F. D. A around the study design last year, we initiated part two of the potentially registrational portion of the trial there.
The first 40 patients are being randomized one to one between the more frequent dose intensity regimens.
Following the first 40 patients we plan to enroll an additional 40 patients at the selected dose to complete the study.
The primary efficacy endpoint.
Our R will be based on approximately 60 patients treated at the selected dosing regimen.
As an update we achieved first patient and are actively enrolling patients.
In addition to U P. S. We have completed enrollment of the phase II part one leiomyosarcoma cohort using the three Q4 W. A dosing regimen and are on track with an anticipated data readout on 10 to 15 patients in the second half of this year.
Further the remaining bone sarcoma cohorts in phase II part one are on track to finish enrolling in the second half of 'twenty to 'twenty three.
With regards to safety profile across all sarcoma subtypes, there are no new safety signals to reports.
B a three zero 11 continues to be generally well tolerated with a phase II safety profile across all doses consistent with the profile that we observed in phase one.
Regarding our be a three zero 11 phase II study in actual positive multi refractory non small cell lung cancer. We continue to be encouraged about the data from the Q2 W. Dosing regimen, while we anticipate data from the more frequent dosing regiments.
The scant treatment options in patients who progressed out of immune checkpoint inhibitors have suboptimal overall response rates were actually 10% to 20% and four months PFS rates.
Part one of our phase two study in non small cell lung cancer as long ago, and again excellent positive patients who have previously experienced failure of either PD, one PD L. One egfr or alk inhibitors and continues to enroll patients.
Dissipated data for all dosing regimens assisting with the study design for the potentially Registrational portion of the trial remains on track for the second half of this year.
We have submitted a meeting request to the FDA for potentially Registrational B, a three zero 11 phase III part two non small cell lung cancer study design and anticipate feedback in the second half of this year and as a result remain on track to initiate the phase two part two study in non small cell lung cancer.
So in the second half of this year, maintaining our overall timeline for development of the non small cell lung cancer indication.
We continue to believe be a three zero 11 has the potential to become a significant commercial asset for bio Atlas and of even greater importance. A first in class treatment for a significant number of patients who failed at least one prior line of therapy, thus addressing a significant unmet medical need.
Regarding the ongoing multicenter investigator initiated phase two clinical trial in patients with platinum resistant ovarian cancer. The trial is fully enrolled and remains on track for the interim data readout consisting of 10 patients in the second half of this year.
Now turning to our second cab D C asset B, a three zero 21, a cab or to a D C.
Currently be a three zero 21 is the subject of phase two trials in the treatment of four different indications.
We conducted a similar exposure response analysis aboard two positive tumors to afford the more frequent dosing, Tennessee regimen of three Q4 W and our phase two where two positive non small cell lung cancer study.
Based on this analysis, which is a similar strategy to our U P. S phase two part to be a three zero 11 study I mentioned earlier, we are screening and enrolling patients.
Based on the activity to date, we believe that we remain on track to obtain data this year to permit clinical trial prioritization across our portfolio.
Regarding the melanoma phase two trial in patients who have previously experienced failure of PD. One therapy, we are continuing to screen patients with a validated I H C liquid biopsy assay.
As we stated last quarter, we have successfully identified what's your positive chillers using liquid biopsy assay, which is allowing us Twitter World War two positive patients and we are on track to dose patients in the second half of this year.
In addition, our phase II head and neck study is ongoing in patients who have previously experienced failure of PD, one therapy alone or in combination with platinum therapy.
Earlier this year, we announced achievement of first patient in for the study.
Since that time multiple patients have been dosed and we continue to enroll patients.
Regarding the ongoing multicenter investigator initiated phase two clinical trial in patients with platinum resistant ovarian cancer.
While is fully enrolled and remains on track for the interim data readout, consisting of 10 patients in the second half of this year.
Yeah.
Now turning to our phase one two trial for our cabs see till a four antibody D. A three zero 71.
As a reminder, the phase one two trial is being conducted in tumors known to be responsive to seek the L. A for treatment and we are continuing to evaluate safety and tolerability of three zero 71 in monotherapy and in combination with of all of that.
The trial is progressing as planned.
Last quarter, we shared that we started treating patients in the fifth cohort of 350 milligrams or five megs for Chegg as monotherapy and in combination with three megs per kick the ball on that.
As part of today's update I'm happy to report that the D. L. T observation period was cleared for the fifth cohort and the O D. L Cheeseboard reported.
We are currently enrolling patients in the cyclical heart at 700 milligrams or 10 makes for Chegg as the monotherapy or in combination with three mix per kg in the roadmap and remain on track for phase one data readout anticipated in the second half of this year.
Okay.
We also remain on track to initiate the a 371 phase two study also in the second half of this year.
We believe there are significant unmet medical needs with a sizeable commercial opportunity. It is across multiple tumor types, where she till a ford can deliver efficacy with a manageable safety and tolerability profile that allows patients to stay on therapy for longer and thus achieve the full benefit of this important therapy.
Next onto our potentially first in class dual cab bi specific T cell engaging antibody.
Cab Camden Cab C D three or D. A three 182.
As mentioned during last quarters call, we received FDA clearance for a variety for the treatment of advanced adenocarcinoma.
We are now actively enrolling patients in this phase one study with the full data readout remaining on track for next year.
Similar to our other three clinical stage cab assets. This antibody has shown significant promise and in vivo preclinical studies demonstrating in over 100 fold improvement in the therapeutic index relative to the non cat areas due to the combined selectivity of the dual cab design.
We believe that our dual cab design has the potential to address the tremendous suddenly that need across several of the most common subtypes of adenocarcinoma, including colon lung breast pancreatic and prostate.
Finally, we continue to pursue opportunities to share our progress with the medical and scientific communities with an additional two trial and progress abstract one for B, a three zero level and another for D. A three zero 21, which were accepted for poster presentations at the upcoming World conference on lung cancer.
September .
This brings the total confirmed medical meeting presentation talent to 11 since the beginning of the year.
Additional abstracts have been submitted for several upcoming meetings as well.
With that I would now like to turn the call over to Rick to review the second quarter 'twenty to 'twenty three financials right.
Thank you Jan as of June 30, 2023 we had $168.7 million in cash and cash equivalents compared to $215.5 million as of December 31, 2022.
We expect current cash and cash equivalents will be sufficient to fund planned operations, including all ongoing cab product development programs into 'twenty 'twenty five.
As a reminder, we control all cab product market rights in the U S Europe and Japan.
Our business strategy includes.
Advancing commercial preparations in key global markets, while exploring opportunities to extend our cash runway by generating upfront cash who the collective licensing of product rights in certain territories all collaborations with other biopharmaceutical companies that could also prove.
<unk> to us.
Element and milestones and royalties upon regulatory approval and commercialization and create additional value for stockholders.
But the second quarter ended June 30, 'twenty 'twenty tree, we reported a net loss of $35 8 million compared to a net loss of $28 9 million in the same period of 2022.
Research and development expenses were $31 million for the second quarter ended June 32023, compared to $27 million at the same period in 2022.
The increase of $10.3 million was primarily driven by our preclinical and 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 our clinical programs.
General and administrative expenses were $6 $2 million for the quarter ended June 32023.
Two 8.3 million for the same quarter in 2022.
The $2 1 million dollar change was attributable to a decrease in various administrative expenses well the 'twenty to 'twenty three period.
We expect our G&A expenses to moderately increase to support development of our product candidates.
Our intellectual property portfolio.
CT focused pre commercialization activity for our asset B, a three zero 11, and satisfy requirements as a public company.
Net cash used in operating activities for the six months ended June 32023 was $46.7 million compared to net cash used in operating activities of $42 1 million for the same period in 2022.
The increase in net cash used in operating activities for the first six months of 2023 is primarily due to an increase in research and development expenses.
Related to our program development efforts as compared to the first six months of 'twenty to 'twenty two.
And now back to Jay.
Thank you Rick we are pleased with the progress we have made to date and cumulative results that continue to support both the preliminary efficacy and safety from our differentiated proprietary cab platform.
We are encouraged with the compelling clinical profile that is emerging at treatment refractory U P. S. At non small cell lung cancer and are eager to start evaluating data from our phase two studies with the addition of the more frequent dosing regiments.
We also are excited by the continued clinical execution of our other promising cap assets in particular, our E. Three zero 71 cab see till he for clearing the fifth cohort with no D. L cheese observed and are well positioned to reach several value, creating milestones in key inflection points by year end.
While we remain confident about the future with the goal of pursuing indications of high unmet medical needs that we feel will have significant impact for patients and our shareholders worldwide.
With that we will turn it back to the operator to take your questions.
Thank you we will now be conducting a question and answer session.
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One moment, please while we poll for questions.
Okay.
Sure.
Thank you and our first question is from Kelly <unk> with Jefferies. Please proceed with your question.
Hi, This is Dan.
On from a debt placement.
Thank you for taking our questions I have a question on the on them.
Is it clear that just don't make it too can you talk a little bit more what kind of.
Data have you provided to the FDA and does it include.
And the data to make a decision on active duty.
Yeah, I mean, I think what we've really approached the F D a workers.
<unk> related to a study design.
And basically both.
With respect to whether it's a randomized trial single arm trial, and we've provided a basic update of the things that we have to date and maybe Eric you want to add.
A little bit more.
Sure. Your question was about whether we've provided data regarding our recommended phase two dose I believe.
And presently are we've we've submitted questions to the agency just as Jay had mentioned about the overall study design.
Randomization some of those features we anticipate preparing a more information regarding our dosing regimens in the briefing book.
Alright and.
One more thing how many.
Patient data do you expect to include and and and and upon launch and do you have any internal bar to move forward for multiple on iron ore.
Yeah.
Yeah.
Eric you wanted to start with that one.
Sure we are evaluating patients as shown in our corporate deck I'm at multiple dose levels.
More dose intensive regimens and I anticipate we'll have a fulsome analysis of those data by the end of the year that we can provide to the agency as a part of the project Optimists.
And I would add that you know, we're a testing basically three different.
Doses the every other week.
The Q3 W as well as a three Q4.
Well, we will have a little bit more data on the Q2 W.
We believe we will have sufficient data for all of the all of the doses for a go forward decision, how we're going to approach it.
Okay. Thank you for taking my question.
Thank you.
And our next question is from Brian Cheng with J P. Morgan. Please proceed with your question.
Hey, guys. Thanks for taking my question. This morning, how does that then just a couple from me maybe first on <unk> 'twenty one.
Given the number of potential opportunities here for the molecule. How do you think are the factors to consider when making a prioritization decision. What is your latest thought on collaboration or partnership.
That could potentially built in desktop consideration.
Yep.
We're making these kinds of decisions, Brian I think we're gonna be looking across the entire portfolio, we have to weigh the app.
OXXO indications, where you know the fact that we're in a learn the axle and also.
Were too low.
How many lung indications should we take forward at the same time, we'll be evaluating that that's going to be related to data.
Also where things are.
Safety Wise I think were across the board feels very comfortable across all the indications so.
Thank God I know personally I'm very interested to see how they're heading that reads out we're still accumulating data.
Likewise, along the course on both of those actually I have more to say, we expect to see are on track to see ovarian cancer data as well and by the way just as a footnote at the time of our right up on the script, we haven't dosed a melanoma patient yet, but at least we crossed that line today.
I think that's truly going.
That's gonna give us a nice picture of that as well, which we expected, but it's nice to see it maybe a little ahead.
So overall I think we have more indications or more drug opportunities that most companies have so you've got an opportunity to really pick the best ones to advance and that also gives us some freedom for partnering as well.
So I don't know that's a maybe a high level of response and maybe I don't know if share you want to add anything else to it but you don't don't feel obligated.
No I think you've covered it John .
Yeah, maybe just one more on a 30 71 any color on a clinical activity so far west fifth cohort dosing and just how should we think about the potential indications.
For the phase two dose expansion cohort.
Yeah, I mean, that's the safety wise.
We're very happy with that we're also very encouraged without getting into any specifics, but with the data readouts that we're seeing already and.
So I would say.
As we said in the script, we're excited about that asset and we continue to be and I think.
You'll recall that we're testing this across eight different.
Indications all known to have some responsiveness to see till it for.
And so where we've done a fair bit of analysis on which ones, we are likely to take forward but.
You know I think we're going to see how the next cohort.
And tightened that tightened that view.
But I think at this point I certainly wouldn't be ruling out any indications. However, there would be some better I think.
Is that a have a great opportunity and.
I would prefer not to list them now because this is an evolving asset and.
I really like the data, we're seeing with the combination with PD one PD one of three legs of a caregiver clearly with the five extra kick in we're already.
Oh dose the patients out there at this next level so it's ongoing.
Great. Thanks for taking my question.
You know I should have added Brian the one nice thing about seats L. A four is that it also opens up the door for future combination therapies.
Just like in.
An analogous way that are PD, one has done with so many different other therapies. So.
One can't help but sit back and think about that those possibilities. In addition to.
You know just combine it with PD one.
Okay.
Thank you.
Our next question is from Caveri Polman with B T. I G. Please proceed with your question.
Yeah, good evening everything.
Yeah.
Phase two trial, it's a relatively small sample size any color on when do you think you'll be able to complete the frequent dosing study and.
I'm well.
We are reporting efficacy data from these cohorts for selection of the right schedule on that.
One would be allowed I think some.
Some patients will be part of the pivotal trial.
Well, if we're talking about lung.
We do anticipate a well we'll have the data.
Enough data for the more frequent dosing to make.
The plan for going forward or to a Registrational study. This this half.
This year.
We are and have identified a medical meeting where we intend to provide an.
An update on our data both for the every other week dosing as well as the more frequent that we're saying we're going to report on that day, they have to be formally get accepted.
At that meeting so we we believe that's on track for communication this year, that's with Axel and lungs.
Yes of course, as a registration or potentially registrational now.
It will not be reporting on that until later next year once we get further down the line on that.
And then the ovarian studies, we intend to report out on those both for the outdoor low to where.
Certainly we are hopeful that we will have sufficient data well it would be wrong to asset to allow us to.
In fact, the prioritization across our portfolio are.
Both from the standpoint of what we want to pay for what we might want a partner et cetera.
I'm not sure that we're gonna report out about efficacy data or two this year, but certainly.
Have some sense of the prioritization.
And of course see till way for I think also we're gonna be truck will be giving updates.
Routine updates on as we progress through phase.
Things one are about I think is a little.
We will also guide a little bit of where we're going ahead with the phase two study as well.
Actual readout on that is probably most of our plan.
As we reported earlier in the year is to align with medical meetings for us.
I'll read outs, but we're trying to break into as many of those as we can into this year.
Got it.
And then I believe for ovarian cancer with Al you mentioned that you have completed the enrollment but can you tell us how long. These patients have been on treatment and will you be able to provide and even though on durability.
Well you know they used to have started some time ago that maybe allow Eric to give some better feedback on the timeline, but I'll just remind everyone. These are I T studies, so the actual where we're waiting on the data ourselves.
So what I hope are we know it is not too far off in the future. We've been told by ice two studies, we know they're fully enrolled so we should have a nice snapshot, but Eric maybe you want to get a sense when things started keeping in mind all of the patients have oh come on board at different times. So it's hard to give a specific number but Eric do you want to add some more.
Color to it.
Jay I think you've characterized that really well you know we started working with the Canadian clinical trials group back in in 2020 about this.
And then we had a mature protocol and started enrolling patients at different times in the two different protocols I mean, the two different regimens one for the Aurora two asset and the other for Axel.
We're looking forward to seeing these data as well.
So I think we'll get there.
Got some inside on the durability, obviously, the latter patients in that study will have a little less than the earlier ones, but that's the way it works.
Got it and maybe a last one.
Besides exploring the dosing schedule do you also plan to continue to explore <unk> expression score for each tumor type to confirm the patient population that response to the treatment.
Any changes you expect or need to make in terms of your companion diagnostic tests.
I think.
The companion diagnostics.
Path forward. It you know it was in good shape I would just say, though we are you know I think we reported out earlier.
Our end of the year that we had at least one tier 1% T. M. P. S score level at logs. So we are we are exploring a bit further and without getting into too. Many details at this point, but yes, that's certainly on our mind and we're evaluating.
Thanks for taking my question.
Thank you and our next question is from Arthur He with H C. Wainwright. Please proceed with your question.
Hi, good afternoon, Eric and as Sherri, Thanks for taking my question.
I had a so far the.
30, 71 data update so.
Could you just tell us the current the <unk> makes it.
<unk> combo.
What's the average HEICO was up.
Oh, Yeah 30 70.
He won't be dosed.
It can be very long because I think we reported out that are we were just those things down.
Sure.
Kind of a may time frame.
Something like that and I made you that I think it also at some of the conferences, we may or June .
So you know you can only expect that to be.
A couple of a few months, but you know I think in general we're encouraged.
With what we're seeing.
Okay.
Thanks for that and Oh by the way.
Arthur I should add though but we have earlier.
Earlier it does those levels that just happened to be earlier that several of those have gone on for quite some time as well over the three to four cycles that are normally attainable.
I see I see yeah.
Therefore, they can make a kilo.
No.
In the monotherapy dosing stage or it has already reached a combo dosing.
I think it's Oh, yeah, we don't have a precise I know why that's made it but I don't have much more information.
But so that's about all I've got.
<unk> right now.
Just see how it plays out.
And my second question is on the S. Cam program. So congrats on the progress and.
So far the data update a week.
Next year.
Could you.
Give some update on the enrollment status for the study and.
Regarding the updated what kinds of data we could expect.
Well, they're realm, it's active active cross many centers, which we had to roll out across and so where we're happy that that's rolling and I think it fits our timeline and we should be able to I don't know, where we're going to get the first update on that.
It will certainly be.
We're just basically would be a little bit similar to how we're handling see till a four but I don't think we would give too much insight on the early doses.
Because they're probably.
Less relevant but as we start to March up towards I would say you see 50, where we start to see efficacy expectations that I think looks a little bit.
But clearly.
Clearly we're on track for next year, I would say everything looks right now so that's an exciting.
Asset no question.
Awesome. Thank you. Thank you for taking my question and congrats on the progress.
Thank you.
Thank you and our next question is from Tony Butler with E. F. Hutton. Please proceed with your question.
Thanks, very much Jay two questions 130 71 please.
Is.
At 700, Migs Q3 W. Do you will you have enough.
Durability.
In the three to six patients that actually tells you that you need to move forward with.
Whatever.
Two ish or three ish cohorts you wish to move forward with question one number two is.
Though you said you've done a lot of work on each of those seven cohorts.
The notion that any one may be better than another I guess.
Yeah.
Would you would you are you limited to two is really what I'm, saying, which is what you stated in your in your corporate presentation.
What do you mean limited to two two combo select up to two for potential.
No no.
And so for example, the north Sea C or whatever okay.
Yeah, Yeah, I think we have a a lively discussion around that exact point, Tony I'm kind of glad you asked it I think the reason we set up that two well, it's because we're confident we're doing too I don't mean that and I don't mean that to say, we're not gonna couldn't do more than two but for now I think two looks pretty.
Solid and theirs.
There could be a decent argument to consider more I think with respect to.
What dose we end up with an N durability I think that remains to be seen but you know the one's got to love. The fact that you were at five mix per Kid with a plus three on the PD. One sided you haven't got a D. L T at all.
But to at least dosed the people or we'll just see where patients are where it goes at the 10 day per kid with three legs kicked on PD one.
This is.
It's <unk>.
The Unchartered territory, you know he'll just for PK and adjust for a few of the things we really liked where this asset is going and I think.
I'm hopeful it'll highlight.
What I think is the powerful advantage of cap technology.
Within that statement and thank you for it.
But the real notion is.
Is there added is there any reason to assume even though you've made for the sake of discussion we don't know.
Any any notion to say that two X 30, 71 dose about 350 to 700, let's say really gives you added efficacy. Despite the fact that the side effect profile.
Well I think we know from other pretty manageable.
Yeah, I think you know from past studies with other seats away for US. If you can two things if you could potentially increase the dose or and or if you can keep patients on more cycles, you do translate to a better outcomes. If you can manage the safety.
And I think there's a there's a fair bit of literature around that that's not quite as much the case with PD, one and that was CTO before there is a there is support for that and that actually was the original objective.
Could we number one get to a higher dose in combination with PD. One that's one question.
The second question was could we.
Get beyond three to four cycles in the combination therapy with <unk> four PD one.
And the third question is could we do both.
And that's what we're on the precipice of answering it I think we've already answered a portion of it.
With the five <unk> plus three names that we've cleared and that of course, we'd like to see a readout for a few more months or so all of this thing is going forward here attitude that way at all.
The right timeframe to look at and I think we're going to have a great and encourage your answer I'm hopeful later this year.
It's been very helpful. Thanks, so much.
Yeah.
Thank you and our next question is from Reni Benjamin with JMP Securities. Please proceed with your question.
Hey, guys. Thanks for taking the questions you.
You mentioned that you identified the war two positive tumors using liquid biopsy can you talk a little bit about how many patients were identified and what does this kind of telling you about the proportion of <unk> patients in the real world versus kind of epidemiological studies and in the numbers we get from that.
Yeah, it's kind of interesting.
In melanoma, you know youll recall that we source approximately 7% positivity rate for war to melanoma, usually and I see us.
Histochemical assay.
As we transition to the liquid biopsy, we haven't given a definitive number but I can tell you. It's certainly double digit positivity rate. So it's clear that the liquid biopsy because we've done a lot of validation around this assay has a you know it seems to be more sensors being able to pick up.
Patients are that are wrong too positive, but at a lower.
Probably a more associated wobble, so were seeing more patients. So that's an advantage that goes beyond the fact that it's much easier to perform that assay. So I think the lesson. Here is is that every assay has a certain sensitivity and and of course, the only patients that we had studies we had.
One patient and are Evaluable patient if there's one we had one valuable patient.
Come across them to her.
These are two study.
Partly only one and one that were valuable because of the low AR positivity rate well. If you can start to move the positivity rate up then youre going to get a lot more patients wanting to come on board to do the study, it's a lot easier to take a blood draw that it has to go and get a tumor biopsy from the patient.
Question remaining is what is that threshold that allows you to see that activity, but you know with adcs.
A lot of history to say that that could be a wide range of reaction and so like in our head and neck. We saw something in the teens you know it was T. M. P. F score the tiers that we saw a P. R right out of the first dose. So long story short this liquid biopsy is allowing us to see a lot of.
The number of paid shows Oh from AR positivity standpoint. The next question, we're hoping to answer those.
Do we maintain a strong.
Response rate in this group.
And we should be able to answer that in the near future.
Got it and I I think I've asked you this before but now that you're dosing into the melanoma patients do you kind of wait to see how this reads out before.
You know testing the the other indications with this liquid biopsy or do you kind of.
I think in the past you may have said that all with these other indications you have quite a robust four two expression and so we don't really need to use the assay.
Well.
We are yeah I think.
Rolling It out we definitely are working at the research level to make sure. We have it covered in these other areas, including absolute if we need it however to roll it out.
With the expense that you might want to put behind the companion or need to put behind the companion diagnostic no. We wouldn't do that until we got more confirmation.
Beyond.
While we have at the moment because we're keep in mind. We're also wanting to manage our capital or we're forecasting to get into 2020 five or that makes you gotta be you got to be prudent in how you do things.
Got it.
One final one for me the the phase two investigator sponsored ovarian study and platinum resistant ovarian cancer you are getting the 10 patients what kind of data do you need to see you know a bogey would still like to have.
So that I don't know it would be kind of brought back in house and developed under our corporate <unk> versus you know do you think it is in Iowa.
It is and I S T or is this something is this an indication that you would really just like to be seen developed by somebody somebody else, even if it's an academic partner.
Well, we've had we've had corporate with Oh.
Companies ask us about the ovarian cancer so.
There's interest out there.
And what the exact cutoff is interesting because it you know it depends on how that whole field is emerging at a little bit, but I think the bar is fairly low at the moment in terms of what you need to see.
To advance this but I think how we'll take that forward is gonna be linked to the data what that exact cut off will be.
It's still being debated but yeah.
That's hard to answer at this particular second we have our own.
So I mean, I would say I'll just throw out I think 20% still quite viable if you see responses and then keeping in mind, though.
All of these drugs get approved on PFS and not or are so I just have to keep all of it as well as overall survival. So we have to keep all of these various aspects of mine but.
We're keeping an eye on it and we are we look at it as an upside that's a study that we wouldn't have been able to fund ourselves at that time.
And.
In combination with PD L. One so it's going to be an interesting read out one way or the other.
Got it perfect. Thanks for taking the questions.
Thank you.
We have reached the end of our question and answer session and with that I would like to turn the floor back over to CEO , Dr. J sharp for closing comments.
Well I just appreciate everyone's attendance and though we've got a very a very active fall here coming up and that we really look forward to speaking with everyone.
At meetings and other venues.
Go for it but thank you for your attention today.
Thank you. This concludes today's teleconference. You may disconnect your lines at this time.
Thank you for your participation.
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