Q1 2022 Bioatla Inc Earnings Call
Okay.
Ladies and gentlemen, thank you for standing by your conference will begin momentarily. Thank you for your patience and please continue to standby.
[music].
Good day, and thank you for standing by welcome to the bio at La <unk> first quarter 2022 financial results and business Conference call. At this time, all participants are in a listen only mode.
After the speaker's presentation, there will be a question and answer session to ask a question. During the session you will need to press star one on your telephone. Please be advised that today's conference is being recorded.
If you require any further assistance. Please press star zero I would now like to hand, the conference over to Chris Bruce Mike Michael Lifestyle Advisors. Please go ahead.
Okay.
Okay.
Yeah.
Thank you operator, and good afternoon, everyone with me today on the phone.
Doctor J shorts, Chairman CEO and co founder.
Scott Smith President <unk>.
Felipe margin chief of clinical development and operations.
Gary <unk>.
A new Vice President commercial strategy, and Richard Waldron, Chief Financial Officer.
Earlier today, <unk> released financial results and a business update for the quarter ended March 31, 2022, a copy of the press release is available on the company's website.
Before we begin I'd like to remind you that statements made during this conference call that are not historical facts are forward looking statements within the meaning of the federal securities laws, including but not limited to statements regarding our business plans and prospects.
Excellent operating performance and expectations operating costs and expenses.
<unk> pipeline clinical trial, and regulatory timing and associated resource requirements are program and potential partnerships and the advancement of our cab technology and product candidates.
These forward looking statements are based upon <unk> current expectations.
<unk> and involve assumptions that may never materialize or may prove to be incorrect.
Actual results could differ materially from those anticipated in such forward looking statements as a result of various risks and uncertainties.
Scribes and bio Atlas annual report on Form 10-K filed February 28, 2022, and subsequent filings with the Securities and Exchange Commission.
Accordingly, you should not place undue reliance on these statements.
All forward looking statements made during this conference call are based on management's assumptions and estimates as of today may four 2022.
Outlet undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after today.
As required by law.
With that I'd like to turn the call over to Jay short.
Chairman CEO and co founder of bio Atlanta, Okay.
Thank you Bruce Thanks to everyone for joining us for our first quarter 2022, and first ever Biola earnings call.
This is a clinical stage biotechnology company focused on transforming cancer therapy with the development of our novel class of highly specific and selective antibody based therapeutics for the treatment of solid tumor cancer.
Our conditionally active biologics or cabs target known and widely validated tumor antigens that have previously been difficult or impossible to target by exploiting characteristic ph differences between cancer cells and.
Normal healthy cells.
Since our IPO in December of 2020, the broad applicability of our cap technology has allowed us to continue advancing the development of our innovative clinical and preclinical programs. We have five potentially registration, enabling ongoing phase II trials for our two latest stage cab ADC prop.
<unk> candidates.
Mike.
Matt the delta or be a 3011.
And as you look the mab the dozen.
Or be a zero to one across multiple solid tumor types for these first in class therapeutic candidates bottler is also supporting a multicenter investigator initiated.
Trial for both our lead assets in platinum resistant ovarian cancer. Additionally, a phase <unk> basket trial for our tabs until a four antibody <unk> zero one.
It has been initiated and is currently ongoing.
Finally, <unk> has several candidates and our IND, enabling preclinical pipeline that include cab by specific next generation ADC antibodies targeting unmet medical needs in multiple types of solid tumors.
We are pleased with our continued progress during the first quarter across our many clinical programs and believe we are well poised for another strong year of execution in 2022. Most importantly, we are excited to share the updates on our ongoing clinical programs with you today in particular interim clinical data from our phase III <unk>.
This study with our lead asset.
<unk> 011.
With that I would now like to turn the call over to Felipe Martine Chief clinical development and operations to provide the topline interim clinical data update from our phase III start combo studies.
Thank you Jay and good afternoon, everyone before providing a top line interim update on our phase III sarcoma study.
I would point out that we have posted slide topline interim clinical data on the investors section of our company website.
In some presentations.
Our ongoing potentially registration, enabling open label phase II trial of <unk> one one.
Designed to evaluate the efficacy and safety of <unk>, one one ultimate Malaysian patients with refractory soft tissue Lindbloom sarcoma.
Yes, two parts to the phase two portion of the trial.
We handle approximately 70 patients across seven different sarcoma subtypes.
<unk> <unk> hundred one monotherapy.
And across all sarcoma subtype to receive <unk> hundred one in combination with <unk>.
Equally between CB <unk> positive and <unk> negative tumors question.
Patients with selected based on actual question.
Each sarcoma subtype.
These subtypes in soft tissue sarcoma can be Leo MEO sarcoma, synovial sarcoma depots sarcoma or the soft tissue sarcoma, including undifferentiated pleomorphic sarcoma with UBS.
While bone sarcoma subtypes, including <unk> Ewing sarcoma, and other bone sarcoma subtypes chordoma.
And for Continental sarcoma.
The purpose of part one.
The phase II study was to identify sarcoma subtypes.
That do not respond to <unk> treatment and eliminate these subtypes, we're moving forward into part two of the study.
Predefined go no go criteria for the interim analysis determines which subtype may advance to part two of the study the threshold for a go decision either at least one partial response or complete response or subtype or progression free survival or PFS rate of at least 40% at three months.
Our preliminary interim analysis of part one of the phase II study that we will share today based on efficacy data cutoff date of April 28 2022.
Achieved and even exceeded pre defined criteria and multiple sarcoma cohort, including <unk> sarcoma.
Specifically in EPS in the monotherapy cohort in the observed <unk> out of five patients, which satisfied our predefined go criteria on part two more phase two.
We observed an additional PR ups's patients in the combination cohort, resulting in a total of two prs <unk> patients treated with an objective response rate of 33%.
Consistent with what was observed in phase, one and when combining phase one and phase two data at the recommended phase II dose of $1 eight kilogram per kilogram.
<unk> were observed for <unk> patients with no or 50% in PFS of three months of 50%.
Importantly, we are observing durable responses and partial responders are able to remain on treatment for extended periods of time some of the mountain study for over two years.
In the phase II osteosarcoma cohort, we enrolled a total of six patients and observe the PFS rate of 67%.
To date, our predefined go criteria to part two of phase two.
When combining phase one and phase III data at the recommended phase II dose of one milligram per kilogram, we enrolled a total of seven patients for the PFS rate at three months a 57%.
For context, we since studies have shown that the placebo PFS rate for first and second line metastatic sarcoma patients.
Eight weeks is at or around zero percent.
When combining all stage, one and two bone sarcoma patients we enrolled a total of 17 17 patients and observe the PFS rate at three months or 56%.
We're encouraged by these interim results and <unk> sarcoma in view of the significant unmet need we believe we have an opportunity for potential accelerated regulatory approval for <unk> in this document.
We intend.
Advance these two Stockholm as two separate cohorts and are working toward a meeting with the FDA by July of this year and anticipate enrollment in $2 two to begin shortly thereafter.
Consistent with the purpose of things one we also identified a cohort that will not advancing two part to that cohort is naomi recycle them.
The PFS rate observed in the Ohio sarcoma cohort was 27% that's below.
Below the threshold established by the predefined criteria.
This way the spending confirmation of some patient is seen on treatment they have not yet reached.
Three months.
Based on the data. So far we are approved that are the cohorts will be moving forward into part two of phase two soon as more patients get to the three month Mark.
We are continuing to enroll and dose patients.
Across four additional cohorts to mobile promo nipple sarcoma, Ewing sarcoma and other bone sarcoma.
And with that we'll be providing that as soon as we go no go decision is reached for each of these scores.
With regards to the safety <unk> was generally well tolerated with a phase III safety profile consistent with the profile observed in phase one.
As of the safety data cutoff of March 31, 2022, there were no treatment related deaths and we observed a few treatment related serious adverse events and adverse events leading to discontinuation.
Treatment related Aes were generally consistent with their meaning the CCD relate.
Related Aes generally did not lead to treatment discontinuation.
Two patients out of the 68 discontinued treatment due to treatment related Aes <unk>.
Both were great too painful neuropathy.
With that I'd like to thank you for your attention and would now like to turn the call over to Sharon <unk> Senior Vice President commercial strategy, we will highlight the significant unmet need and commercial opportunity in sarcoma.
Sorry.
Thank you Fermi and good afternoon, everyone as you all know.
Robert Kwan.
Hi.
And limited therapeutic options and the five year survival rate for advanced refractory.
Sarcoma.
Approximately 20%.
As a consequence, the high unmet need.
Regular train crash timeframe.
Great.
Thanks, Tony.
Thank you.
Well below 15%.
Yes.
Okay.
Brian .
Ashok so it'd be a welcome addition.
The limited treatment options for these refractory sarcoma patients.
UBS.
Just back on that.
Nearly 15%.
That concludes our comments.
So one of the most aggressive.
With one of the highest.
Thanks.
Hey, thanks for the cash back to EPS.
Very rapidly.
Andrew achievements cash.
No.
<unk> treatment.
Thank you.
Yes.
Thanks, Tim.
This afternoon diagnosed in children and young adults.
<unk> sarcoma much comments Nathan.
Hey, Brian .
<unk> myeloma targeting 30%.
Alright.
And frequently occurring.
Right.
Nearly 20% of osteosarcoma patients.
Yeah.
The remainder 50% events.
Any progress.
Okay.
Serge.
Please go ahead Sir.
Chemotherapy and radiotherapy.
With suboptimal success.
In addition to the high end.
<unk> comments.
A significant commercial opportunity.
There are approximately five seven.
Our EPS.
<unk> sarcoma patients per year.
With the potential to generate upwards.
There is dollars in royalty revenue.
The FDA has granted orphan drug designation.
Thank you Matt.
Tissue sarcoma.
<unk> sarcoma patient population.
Josh could treat that can be served by a highly change relatively small marketing professionals and commercial infrastructure.
High volume centers.
Sure.
Based on the encouraging interim data.
Thank you <unk>.
One line of sarcoma study.
We're excited that our lead CAD ADC.
Hi, Carlos.
Sorry twice, our transition to a commercial stage company.
A significant part.
Okay.
Now I would like to turn the call over to Scott Smith President of dilemma.
And over to you and other ongoing clinical programs.
Bob.
Thank you Sherry and good afternoon, everyone.
I'm going to take a few minutes to run through some key operational updates and upcoming milestones before thank you I wanted to reiterate my excitement about the interim phase two sarcoma data from part one of the study.
Significant unmet medical need and commercial opportunity is that we have.
Thrilled to move one step closer toward a potential first in class accelerated regulatory approval path.
3011, multiple sarcoma subtypes.
And also we have a phase III trial ongoing with 3011 in refractory non small cell lung cancer.
Over 40 sites are active in this trial and we're actively enrolling and dosing patients.
Anticipate the preliminary cohort of 20 patients to be fully enrolled by the end of this quarter with an interim update anticipated at or around our second quarter earnings call.
Now turning to our secondly have any C product.
Gross reserve to one <unk>.
As a reminder, there are no other therapies targeting work too in the clinic.
So we have the potential to have a first in class treatment for solid tumors.
And so that's why we saw impressive responses of working positive patients refractory to PD one therapy.
To confirm <unk> in non small cell lung one PR in head and neck cancer and a complete response to the melanoma patients who remains a complete remission off treatment over two years.
We have initiated three phase II trials with three there are two one 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 trial in refractory patients is currently dosing.
Anticipate preliminary cohort of up to 20 patients to be enrolled in the second half of 2022.
Our updated plan. After these patients have received at least three versus therapy likely in the second half of this year.
Turning to the melanoma trial, which is being conducted in patients refractory to PD one therapy.
We have run into challenges with trial recruitment and having only one patient to date.
The overarching positivity rate has been lower than anticipated at around 10%. So it's been a challenge obtaining and invasive tissue biopsies of these patients, which we believe is significantly impacted our ability to recruit the trial.
We are working diligently on liquid biopsy with our part.
We're sorry.
We are currently in the validation phase and anticipate this motivations assay will be available to us in the melanoma trial soon.
We believe there will be a significant acceleration.
With the availability of this liquid biopsy.
We only have one melanoma patient enroll in phase two.
I am very happy to report the anticipation is also achieved a complete response.
When you take into account the complete responses were observed in phase one we now have two out of two watching positive PD, one refractory patients with a complete response, which is quite remarkable.
Well, we're not sure at this point, we remain very excited about the potential of <unk> to one in melanoma patients who are working towards providing an interim update in the second half of this year.
The third phase III study that we've initiated with research one is in refractory patients with head and neck cancer, we anticipate the first patient to be dosed in the second quarter of this year.
To round out our cabin key programs, we are supporting a multicenter investigator initiated phase two clinical trial of <unk>, one one or <unk> two one in patients with platinum resistant ovarian cancer.
This trial was initiated in currently screening patients in Canada, and the United States.
I'd now like to talk briefly about updates for our <unk> four antibody <unk>.
<unk> 71.
The phase one two trials ongoing and will examine the safety and Tolerability of 3071 at doses ranging from seven milligrams every three weeks to 700 milligrams every three weeks as monotherapy and in combination with <unk>.
We are very excited to have this asset back and biologics portfolio and believe there is a tremendous unmet need and commercial opportunity for safer and better tolerated generally four we anticipate the first patient dosed the second quarter of this year.
Turning to our preclinical pipeline.
Several candidates and IND, enabling phase that include tab.
Specific to the second generation ADC antibody.
We remain on track for an IND submission for a cab.
Tab CD three bispecific antibody this year.
As well as for additional R&D filings for multiple preclinical cab by specific and next generation CAD ADC candidates in 2023.
On the BD front, we announced early in Q1, we entered into a clinical collaboration with BMS to investigate our two lead cabinet is used in combination with BMS level.
With that I'd like to hand, it over to Rick to review, the first quarter 2022, and the financials.
Thank you Scott.
<unk> financing is integral part integral parts are allowing part handles overall.
On the corporate strategy, our primary objectives Gulf of Mexico.
Upland operating current product.
The commercialization of page four other major development inflection points, while expanding our product candidate pipeline.
This is intended to optimize our opportunities for future financing and enhanced value for the stockholders.
As of March 31, 2022, we had $219 $4 million in cash and cash equivalents compared to $245 million as of December 31, 2021.
We expect current cash and cash equivalents will be sufficient to fund planned operations, including all ongoing product development programs into the second half of 2024.
We control all cab product in market rates in the U S Europe and Japan.
Selective licensing of product price in certain territories collaborations with other biopharmaceutical companies.
Generate for us upfront cash development milestones and royalties upon regulatory approval and commercialization that could extend our cash runway and create additional value for stockholders.
For the first quarter of 2022, we reported a net loss of $24 $3 million compared to a net loss of $18 7 million in the first quarter of 2021.
All of the $5 $6 million increase is attributable to the increase in research and development expenses from $10 4 million in 2021 to $16 9 million in the first quarter of 2022.
Primarily driven by expansion of our product development efforts, including clinical development for CAD till April .
3071, and preclinical development of additional cab candidate.
We expect our R&D expenses to increase as we continue to invest in R&D activities to advance our product candidates and clinical program and to expand our product candidate pipeline.
Sure.
General and administrative expenses were $7 4 million for the first quarter of 2022 compared to $8 4 million for the first quarter of 2021.
<unk> million dollars decrease was attributable to a decrease in stock based compensation for the 2022 period.
We expect G&A expenses to increase to support development of our product candidates expander intellectual products property portfolio.
Support pre commercialization activities for our lead product candidates.
<unk> 011, and meet all requirements as a public company.
Net cash used in operating activities for the three months ended March 31, 2022 was $25 1 million.
Net cash used in operating activities of 50.
8 million.
For the same period in 2021.
The increase in net cash used in operating activities for the first quarter of 2022.
Primarily derived from the $5 6 million increase in net loss.
$1 million deal.
A decrease in stock based compensation and $3 5 million greater change in certain working capital accounts compared to the 2021 first quarter results and now back to Scott.
Thank you Rick.
As of our IPO in December of 2020, we have continued to advance the development of our innovative clinical and preclinical programs and has achieved a number of value, creating clinical milestones with our kind of assets.
<unk> continues to build our medical affairs commercial capability.
The strength of our balance sheet, we will continue to make efficient use of our capital resources to continue to focus on solid tumors with the greatest therapeutic and market potential.
In addition, we will strategically prioritize our resources in order to execute our efficient.
Can you just clinical trial designed thereby achieving key value inflection points for our company and for our shareholders.
Very excited about the potential range of opportunities for <unk> antibodies to create long term sustainable value trade.
<unk> cancer therapy can have a meaningful impact on patients' lives across multiple solid tumor types.
Thank you for your attention.
With that we will turn it back to the operator to take your questions.
Thank you as a reminder to ask a question you will need to press star one on your telephone.
Your question. Please press the pound key please standby, while we compile the Q&A roster.
Yeah.
Our first question comes from the line of <unk> Rama with Jpmorgan. Your line is now open.
Hey, guys. Thanks, so much for taking the question Mike.
My first question is can.
Can you give us a sense of for the Lymphosarcoma snowmobile.
Ewing sarcoma.
We'll have some of the data in hand, when you go meet with regulators I think you said in July and.
Then.
On the safety side, the two patients with peripheral neuropathy anything in the baseline characteristics worth noting there for those two patients. Thanks, so much.
Thank you for your question.
Afternoon, and hope all is well I'm going to leave more time to directly.
Answer the two questions that you put forward there.
Thank you and thank you for your question, yes, so by July .
We anticipate we will have.
Yes.
Data from the remaining cards that are still that we're still recruiting at the time, we will be meeting with the agency again I'd like to point out that we.
We are working with the agency right now scheduled a meeting.
Yes.
Tentative date that should work based on general timelines, but.
It's based on the agency <unk>.
So I just wanted to make that tier.
And then further peripheral neuropathy.
Baseline for these two patients.
I believe one of the two patients.
Our history of peripheral neuropathy before joining the trial.
We've seen a few of those patients coming in with grade one peso neuropathy, we are allowing that.
And the patients progressed to great too.
So, but I mean two two.
These concentration out of <unk>.
The rate that is perfectly acceptable.
Acceptable going forward, particularly in this multi a refractory patient population that we're studying managers many of whom are coming in with a history of peripheral neuropathy. So again I think it shows a little bit of the cab technology playing out in the clinic because the rates are quite low relative to other adcs studies.
Multi refractory patient population.
Will you have closed some of the data from the other cohorts like doing in synovial sarcoma.
When you have them or how should we be thinking about the disclosure around those cohorts.
Yes.
We didn't want to disclose cohorts, where we are we're continuing to enroll right now and we haven't made a decision on and we don't have enough information.
It's important to note that in phase one we saw responses in UBS, we saw responses in bone and hearings and we saw one in leiomyosarcoma and in those areas we have confirmed.
Fees for at least for about for sure.
UBS, we've confirmed what we saw in phase one we wanted to run that biomarker cohort quite large because we did see responses in phase one and we didn't see a response and we didn't see the breakout of PFS to move it forward into phase two once we have the right information and we will talk to you about this cohorts, we'll certainly update you on the next conference call.
We should have.
A good amount of information to take to the agency to make a decision going forward, but obviously.
I'm really pleased that we are moving forward right now and UBS and Osteo tune the larger sarcoma subtypes and the data that we're seeing is really compelling and very.
Sort of validates what we saw in phase one.
Got it thanks, so much for taking my question.
Thank you.
Our next question comes from Thiago <unk> with credit Suisse. Your line is open.
Alright, Thanks for taking my question. So just one quick.
The market itself.
A few different charts had different values for the tumor membrane for sensor score for the sarcoma. So just to confirm the phase II data that you presented today those are all in patients with 70% plus correct.
That's correct.
We allowed 50% or more but the patients you are seeing for <unk>, we're all 70%.
Laura.
Got it and perhaps the follow up is it basically given the responses that you've seen so far is there any specific underlying biologic rationale on why the drug would be active solely on those barrels.
Subtypes from the phase one as soon as possible is likely more correlated with just acts of expression.
And if you look anyway, even had a Leo made sarcoma response that you would not see on the phase two.
You basically had one response across 45%.
Five stations on the monotherapy arm.
So how confident argue that there is a strong signal here and thats not perhaps just.
False positive tail accident, perhaps going forward.
I am curious if there is a rationale on why you could see.
Such different results.
Yes, so I don't think the results are very different.
I think the results we saw in phase two are.
In line with what we saw in phase, one and we saw a signal and UBS and we reproduced that signal in phase III.
And then my other sarcoma patients.
Patients we are seeing we saw in phase two we're very advanced patients that had failed.
Three or more prior lines of therapy.
We saw a number of patients progressing extremely rapidly.
And.
Because these patients were programmed to advance to be able to see a response.
The PFS.
We are quoting.
27% that number will probably change as we are having a number of new Mayo sarcoma patients that are still growing.
Still on treatment and will reach.
And I have not reached to 12.
Three months time point, yet but.
But that number is still too low for us to move forward do you think that will be competitive in that <unk>.
Bio Psycho minor environment, and then for steel sarcoma.
I think it's been clearly established as a progression free survival endpoint is the most relevant measure.
Anti tumor activity.
Advanced Osteosarcoma.
Rather than objective response, because tumor shrinkage in the calcified lesions of advances to sarcoma may not accurately reflect the true anti tumor activity of the molecule.
So the parent to the external steel sarcoma community sooner and to use a progression free survival.
A more efficient and reliable endpoint in phase III.
When you see the type of response, we are seeing in those two sarcoma in terms of PFS at three months of 67%.
That is highly encouraging for us moving into the space.
Two study in light of the fact that these patients were.
Advanced patients they had an average three prior lines of therapy.
With patients that are meant to study can have one to two prior lines of treatment studies have shown that these patients.
Generally progress within eight weeks.
You see our rate of formation of a 100% of these patients are not treated.
Are there.
Chemotherapy is.
Quite a no PFS rate at 12 months around 14%. So it's a striking difference.
Here.
And that's why we believe we have a strong rationale to move forward in osteosarcoma I want to add.
One other thing to win such a leap was saying and that is for UBS, where we saw a very strong signal in phase one.
We saw two responses one our model as you say one in combination, but we saw two responses in a very small number of patients we could.
And Rob.
10 patients fully and UBS and another five are talent and in combination in EPS, but we saw a signal both in mono and combination very quickly. So we decided not to fill that up and move quickly to phase two.
Given the fact between between phase one and two in EPS, We've got a 50% response rate. It's likely we would have seen other responses. How do we continue to fill up that cohort, but we had enough security to move forward.
Through the Registrational or part two of phase III Registrational part of this cohort. So we were very pleased with what we saw there and very valid over what we saw in phase one.
Got it I appreciate the confidence and the extra information.
For taking my question.
Thank you.
Our next question comes from Kelly <unk> with Jefferies. Your line is now open.
Thank you for taking my questions first.
Could you share what is the enrollment status and medium follow up.
A follow up time for the fall cohort, which are yet to report clinical results.
So it's a good question just let me repeat Kelly. Thank you for the question, but let me just make sure I have it right you want to know the timing for filling up the cohorts, which we did not report on because they weren't fall at this point in time, where we could make a decision.
Yeah, and then specifically I think I am just curious about a medium follow up for that you Radha.
Patients in Datacom fall cohort clearly disclosed.
I'm, sorry, I didn't understand the part two of the question Kelly.
So the median follow up time.
So you have not present, a clinical outcome.
Median follow up time.
Yes median follow up time.
The enrollment of patients in that cohort.
Today's call.
No we havent disclose that now.
Okay.
<unk>.
We will update these other cohorts as we get to the Q2 call and let you know where we are with them I will say just.
Yes.
Sure.
From where we are even though we can't be definitive certainly we see a couple of cohorts here that we're very encouraged by that we're.
We are preparing to move forward as well, but we want to.
You'll get some more enrollment there because they are not.
We're not a sarcoma types that we saw in phase one so we want to we want to get a few more patients in there to make a fulsome decision, but I do believe that based on what we see today and it's highly likely that there'll be other cohorts moving forward into part two of phase two.
Okay. Great. Thanks also have follow after.
Yes.
There is no correlation between actual expression level and the depth of response.
Yes.
For their part.
Ah patients we have enrolled was in fact, one in phase one and phase two.
We're.
How does <unk> sub 70% or more and so we've seen these patients responding.
Treatment.
2% of them responded.
I had a PR.
So it's.
The correlation is that.
Patients that have a GMP of 70% are responding.
More broadly in sarcoma, we've seen that correlation that.
The response comes at around 70% Gnps now we did not in phase one if you recall enrolled patients between 60% and 70%.
<unk> is part of the phase II part one we wanted to explore.
Those patients. Unfortunately, we were unable to enroll too.
Of these patients so far all the rest has a <unk> percent alone.
I will say to add to.
Felipe comments one of the.
Three positive things for us about UBS is not only are the patients who are actual positive. They usually generally have a very high level of OXXO positivity of actual expression, but also most GPS patient, 70% to 80% of them are actually high and so it's a very good population for us to be spending further.
Great. Thanks.
Thank you.
Next question comes from Caveri Polman with BTG. Your line is open.
Good afternoon, and thank you for taking my question.
First question is regarding the PD one combination.
Can you.
Provide any color on your development strategy, there because I believe to be.
A combination of a PD one therapy monotherapy itself is not really approved for glaucoma.
Sure.
Thank you for the questions and good.
Afternoon.
So in general I'll hand, this over to Felipe far more substantial answer, but the general color I believe that we saw is we saw very little if any benefit from the PD one in the sarcoma population.
So I believe unless things changed our development strategy will be to move forward in monotherapy and certainly into two cohorts of our moving forward.
Yes, I don't have much more to add to that I think.
We didn't see a benefit in having their PD one to two.
<unk> won one in sarcoma.
And I think that we were generally we were expecting that but wanted to confirm it.
And so going forward, we'll focus on the monotherapy in sarcoma, let me stress that because.
It might be a different.
May be different than we expected to be somewhat different in non small cell lung cancer, and then I don't know.
Got it.
Regarding the <unk>.
Sure.
Hi.
One of them.
Yes.
So Jacky Lo Archie NPS score for Jack why is it that <unk> with the same payload allows you to 30 months.
Hello.
Yes, so it's not just about the payload until about the level of expression.
Excellent or two on the membrane of the tumors, where we are testing.
And right now what we are doing for <unk>, because we have less information than we have for Axel.
Where we went with a broad <unk>, 1% or more.
Couple of reason one is the fact that we've seen a PR.
Didn't think piece.
Patient in phase.
One that was at 18% tier NPS score.
Therefore, we could have chosen 10% threshold, but we might as well go up 1% and see if we can derive benefit for those patients.
I think it's important for the part one of the studies to really define what the cutoff is going to be.
For <unk> going forward into registration studies.
I also think tasiast deferred stock and important for us to be able to characterize the response relative to actual or more two expression with the regulatory agencies are very important for us to do that it was more definitive in OXXO seem very much more clear to us that high excellent compression.
<unk> responded low actual expression as.
So you've alluded to the head and neck patients, 18% worked your positivity I can't guess at 18%.
They responded very very well so we're trying to characterize the relationship between <unk> expression and response I'll add something else switch.
I think he is not disclosed.
So far the patient that Scott mentioned no matter more to that just had a complete response.
<unk> was 30% three zero right. So it's below that 50% threshold that we have seen <unk> sarcoma.
And so on.
<unk> It makes sense for us to go broad and then narrow it down.
Should we need to do that.
Makes sense. Thank you.
Thank you.
And our next question comes from Tony Butler with Roth Capital. Your line is open.
Thanks, very much I have actually a few questions, perhaps I could just ask them all upfront.
Maybe help.
A little bit so one of the questions.
Is there any evidence that.
Other markers for example, MD.
MDM, two amplification or CDK four applications correlated with response rate that's question one.
Number two is the spider plots.
Joe.
Really quite impressive.
I wanted to make sure that all of the patients.
Who or observed on those Spider plot did they receive at least two scans or were there patients, which only have had one scan with a second to follow.
Question two.
Question, three and I apologize my apologies you stated it I just didn't capture it again or the number of patients in phase one.
On UBS.
Did respond or was that just one patient.
Is it too.
And thank you for taking those questions.
Thank you Tony and I'll answer your last question first and then kick it over to Phil lead to get into more detail on the first two questions in phase one we saw too.
Actual positive EPS patients both of whom responded.
Two two.
That's great. Thank you.
The <unk> one milligram per kilo.
Yes.
<unk>.
So what was your question.
Alright.
Sorry, sorry, sorry, sorry, it's on other markers. So for example.
<unk> amplification or it's going to take for amplification and I'm just trying to see if in fact, there was any correlation to other.
Sure.
Genetic let's just call it genetic abnormalities.
Yes. This is data we'll be able to report once we have the full cohorts.
<unk>.
We've gathered.
Gathering the information and we haven't analyzed it just yet.
I'll be waiting for their food cohorts to do that and then we'll report on it.
And if we see any correlation we would make sure to.
To highlight them for you.
And the second question was relative to scans in the Spider plots. So scans in the Spider plots Ken's Youre seeing are.
You will note for instance that.
It was still a sarcoma.
You have seven patients for the progression free survival for phase, one and two but you only have six patients shown.
The reason is this.
Seventh patient.
That had 12 weeks, yet and have not had a firsthand yet either so but it is captured in the PFS patient being censored.
And but it's obviously not shown on the Spider plot because we.
We have not depreciating.
Undergoing treatment and we don't have a first scan yet.
Yes Felipe also.
That's great but also.
We're all patients.
They have other than the ones you mentioned.
One scan or do some have to scan.
Yes, so most times two scans, but if you don't see us for instance in the sarcoma part as a one line thats overlapping.
And that between two patients.
One of these two patient only has one scan so far additions ongoing waiting for the second scan.
And the other finished at this point.
So all the way from one scan <unk> patient population.
Did I answer your question. Thank you.
Yes, absolutely. Thanks, thanks very much.
Okay. Thank you and again, we'll update this as these patients continue.
Just on the Q2 call.
With with how these patients are progressing and lost for the scans.
Further information at that time as well, but what we see here is very very encouraging and a very.
Walt to treat patient population.
I understand it's preliminary and very early but.
I'd have to ask.
Thanks for the follow up.
Of course thank.
Thank you. Thank you. Thank you as a reminder, ladies and gentlemen, Thats star one to ask a question. Our next question comes from Arthur He with H C. Wainwright. Your line is open.
Hey, good afternoon, everyone does the author from HC Wainwright.
Most of my question has been answered I just wanted to follow up on the LMS.
LMS cohorts for those 17 patients.
Is there any patients get the dose reduction.
Or seven patient received.
The phase II redemption level.
So all patients starting with the phase two dose.
Of one milligram per kilogram and some patient had to have dose reduction I don't have the exact number in front of me, but I can follow up and let you know what that number is but some patients had to have dose reduction.
Because.
Some aes that sometimes were related or not related to treatment.
Yes.
We have a few patients that required a dose reduction yes.
Thanks for that color and switch gear to the $30 21.
In the myeloma.
Could you give us more color on the out too.
Core patient enrolling the phase two study how that compared to.
Score for the patient has a complete response in the phase one.
Yes, so if you recall.
Yes, just mentioned.
<unk> core fundamental of Neuromodulation as a complete response in phase III is 30% three zero 30.
In phase one we were not able to determine what the score that patient was because there were some millennium staining that precluded us from seeing the entire.
Surface of the cell we saw raw too.
To stay.
Training, but we Couldnt give you the score.
And so right now what we know is that went up to two <unk>.
<unk> of 30% the other one we don't have to score.
She'd like to add.
As we talked about when we were in our prepared remarks.
Excited about this program. This is really highly unusual to see two more two positive patients. Both hasnt complete responses there had been some operational difficulties and.
Around the idea that requires an invasive biopsy to get in and out.
Positive 80, right at 10%.
And the sites, we are seeing many more negative biopsies to positive, which led to tourism. So moving towards liquid biopsy I think will help us operationalize. This.
Very very good way and we're really excited about the potential.
Awesome I am looking forward to looking for the liquid biopsy assay.
Okay.
Thank you and I'm currently showing no further questions at this time I'd like to hand, the conference back over to management for any closing remarks.
Thank you and thanks, everyone for your questions Joseph essentially today, we're very excited about the year ahead.
Where.
Okay.
I think.
I don't know if.
I think we might have lost J there, but just thank you very much for your attention and we look forward to continuing to update everybody as we move through the quarters and we are at a very very exciting times with our clinical programs with lots of inflection points coming up and we're very very excited about the future and look forward to continue to update you on our progress.
Thanks Scott.
Ladies and gentlemen off for a second.
Thank you for thanks, everyone. Thank.
Thank you for participating in today's conference you May now disconnect everyone have a wonderful day.
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