Q2 2021 Bio Path Holdings Inc Earnings Call
[music].
Good morning, ladies and gentlemen, and welcome to the bio path Holdings second quarter 2021 earnings Conference call. At this time, all participants are in a listen only mode.
Following the formal remarks, we'll open the call up for your questions.
I would now like to turn the call over to will O'connor of Stern Investor Relations. Please proceed.
Thank you operator.
Welcome to the bio path Holdings conference call and webcast to review the company's second quarter 2021 financial results and to provide an update on recent pipeline and corporate development.
Earlier, we issued a press release, which outlines the topics that we plan to discuss on today's call.
Leases available at bio path holdings Dot com.
With me today from bio path are president and CEO, Peter Nielsen and senior Vice President of Finance Accounting Administration Anthony price.
We begin the call I'd like to remind you that today's discussion will contain forward looking statements that involve risks and uncertainties.
Risks and uncertainties are outlined in today's press release and in the company's recent filings with the Securities and Exchange Commission, which we urge you to read.
Our actual results may differ materially from what is discussed on today's call.
With that I'll now turn the call over to bio paths CEO Peter Nielsen.
Thanks will and good morning.
Everyone and thank you for joining us.
The first half of 2021 was very productive for bio path and I'm pleased to provide an update on our recent progress.
Over the course of the last six months, we have made meaningful progress in our pursuit of delivering a portfolio of targeted new quake cancer drugs to patients in need.
I'll begin with our lead product candidate practices Jefferson.
We continue to make significant progress advancing stage two of our phase II clinical trial of practices you person for the treatment of acute myeloid leukemia.
Or AML in combination with frontline therapy decided in banana clocks.
As we have previously reported phase II clinical development have pressured your berson and AML commenced with stage one of the phase III clinical trial, which was open label untreated de Novo AML patients with a combination of <unk> and low dose cytarabine or held back.
The combination of practices you person at Outback was shown to be safe and more efficacious to treat this class of patients than with <unk> alone.
As many of you know there has been an evolving landscape for standard of care in AML.
Despite these therapies there are still patients who are refractory or resistant.
And those are the patients we aim to help <unk>.
The standard of care evolves, we adapted our trial design to reflect these changes.
The amendment stage two of this phase II trial in AML is an open label phase two two stage Multicenter study are pressured your person in combination with decitabine and vanilla clacks in two cohorts of patients with previously untreated AML and relapse.
<unk> resistant AML.
A third cohort includes treating relapsed resistant AML patients, who are <unk> resistant or intolerant with the two drug combination of <unk> and decitabine.
The final trial design plans have approximately 54 evaluable patients for the cohort treating relapsed refractory AML patients with the triple combination treatment of Brexit your births and decided that in banana clacks and the cohort treating AML patients who are banana clacks resist.
Or intolerant with the two drug combination of Brexit you Berson and decided then with a review of both cohorts performed after 19 evaluable patients.
The full trial design plans have approximately 98 evaluable patients.
Cohort treating untreated AML patients with the triple combination treatment of <unk> decitabine and vanilla class.
With a preliminary review for the cohort performed after 19 evaluable patients at a formal interim analysis after 38 evaluable patients.
The higher number of patients is a full trial design for the untreated AML patient cohort is due to the higher baseline response of the frontline therapy with previously untreated AML patients.
The primary endpoint for this study will be the number of patients who achieve complete remission, which includes complete remission with incomplete hematologic recovery and complete remission with partial hematology recovery.
And in term analysis will be formed on each cohort to assess the safety and efficacy as a treatment.
In the second quarter, we were excited to announce the successful completion of the safety run in of the stage two of the phase II.
And we look forward to advancing this study as we believe its unique design provides us with several of his definable registration pathways.
Next I'd like to turn to our plan to phase one clinical trial with practice rigorous attach a.
Patients with advanced solid tumors, including ovarian and uterine pancreatic and hormone refractory breast cancer.
<unk> diverse and dash a fourth bio path drug candidate is a modified product from Brexit your gross and sharing the same drug substance with enhanced nanoparticle properties.
This trial will be conducted at several leading cancer centers and is planned initially to evaluate the safety of Brexit your burleson in solid tumor patients.
Patients diagnosed with recurrent ovarian and endometrial cancer, often have poor outcomes and it is our hope that <unk> may provide clinical benefit for such patients.
Turning now to BP 1002, our second therapeutic candidate, which targets Bcl two.
As you know Bcl two is responsible for driving cell survival and up to 60% of all cancers high expression of Bcl two has been correlated with poor prognosis for patients diagnosed with AML.
<unk> has also shown activity against anti tonic protein Bcl, two and works by neutralizing the protein's BH III debate.
It is an improved treatment for chronic lymphocytic leukemia, or CML patients and untreated AML patients. However, with the exception of some patients treated with I looked at the amount of poetic cell transplantation disease relapse invariably occur.
Oftentimes due to BH III domain mutation over time.
<unk> 002 also targets the Bcl two protein.
However, <unk> 002 activity is based on blocking the Bcl two messenger RNA and not the <unk> domain.
As a result, we believe that BP was 002 could provide an alternative for <unk> patients, who have relapsed, including AML patients, who previously received <unk> treatments.
In a phase one trial refractory relapsed CML patients, including those who have failed or relapsed from banana flax based frontline therapy as well as refractory relapsed lymphoma patients are being treated with BP 100 to this trial is being conducted.
With several cancer centers.
We expect to initiate a phase <unk> clinical trial of <unk> 002 in refractory relapsed AML patients to be conducted at several leading cancer centers in the United States, including the Wild Medical College of Cornell University, and the University of Texas.
MD Anderson cancer Center.
And the AML trial initially a total of six evaluable patients are scheduled to be treated with <unk> 002 monotherapy in a standard three plus three design with a starting dose of 20 milligrams per square meter.
The approved treatment cycle.
Two doses per week over four weeks, resulting in eight doses administered over 28 days.
<unk> portion of the study will commence after completion of BP 1002, monotherapy cohorts and we will assess the safety and efficacy of <unk> 002 in combination with decitabine in refractory relapsed AML patients.
Finally, let me briefly review progress we've made with our third drug candidate <unk> 100, free which targets the stat III protein.
This program has shown promising preclinical data and we are very excited for the future of this program.
We are studying <unk> zero three.
For the treatment of pancreatic cancer in a patient derived tumor model.
<unk> models have shown the drug to successfully penetrate pancreatic tumors and enhance the efficacy of standard frontline treatments.
We are particularly excited to launch our first in human validation of this cutting edge therapy in an especially challenging cancer indication that has limited treatment options.
We are aiming to file an IND application with this very promising product candidate later in 2021 or 2022.
In June we announced that the United States patent and trademark office has granted a new patent relating to our BP 1003 program.
The new patents builds on earlier patents that have been granted that protect the platform technology.
<unk>.
As I have said before we continue our efforts to build a fortress of protection around our technology as it safeguards our platform technology and target specific technology as a deterrent to would be competitors and creates value around our core competencies.
With that I'll now turn the program over to Anthony price for a brief review of our second quarter 2021 financials, along with balance sheet highlights Anthony.
Thanks Peter.
The company reported a net loss of $1.8 million or 26 per share for the three months ended June 32021.
Compared to a net loss of 2.0 million or <unk> 55 per share for the three months ended June 32020.
Research and development expense for the three months ended June 32021 decreased two point.
$8 million compared to 1.0 million for the three months ended June 32020.
Primarily due to timing of activities related to our clinical trials for BP 1002 in lymphoma.
Perhaps senior person in AML, and Prexy Giberson dash eight in solid tumors.
General and administrative expense for the three months ended June 30th 2021 were 1.0 million consistent with the comparable period in 2020.
As of June 32021.
The company had cash of $28.1 million compared to $13.8 million at December 31, 2020.
Net cash used in operating activities for the six months ended June 32021 was $4.2 million.
<unk> 6.0 million for the comparable period in 2020.
Net cash provided by financing activities for the six months ended June 32021 was $18.6 million.
I'll now turn the call back over to Peter.
Yeah.
Thanks Anthony.
We entered the back half of 2021, and a stronger position than ever to advance our DNA <unk> platform in a number of important cancer indications.
We have a clear path ahead and are looking forward to generating the data to support our product candidates and to bring new treatment options to cancer patients waiting for breakthroughs.
With that operator, we're ready to open the call for questions.
Thank you Vanessa.
Minder, if you would like to ask a question. Please press Star then the number one on your telephone keypad.
First question comes from the line of E Chan of <unk> H C. Wainwright Your line is open.
Hi, Thank you for taking my questions.
Could you comment on whether the evolving pandemic is affecting the enrollment speed.
Craig senior person.
Trials in AML.
Okay.
<unk>.
Have not.
Pat anything reported to me.
<unk>.
In that context.
Part of our enrollment.
If you recall.
We have.
At the manage the enrollment rate.
Our.
Drug supply.
At the end of last year.
Okay.
We had we lost a double batch due to supplier, having a COVID-19 outbreak.
And then following that the replacement double batch.
Had a plant malfunction, so it's kind of.
Anything is possible in this COVID-19 environment, we're now experiencing and having our.
First batch and recovery.
It'll be delivery delivered in about 30 days and then we have more after that so we should be a.
Ramping up quite a bit we've continued treating an enrollment the whole time.
Im concern as I'm sure everyone is.
About.
What's going on with Covid and.
Our patients as you know are immuno compromised.
Okay.
The Covid variant that's out there is definitely so.
But at this point I mean, we've just had some some patients enroll in AML.
So it's a good question good thinking we watch it.
But so far.
Yes.
Halted R R.
Greatly reduced our goal.
Enrollment okay.
Yeah.
Sir cohort with <unk>.
Relapsed refractory AML patients do you.
Kim.
Reached 19 Evaluable patients for end to end review by the end of this year.
Well previously I felt that was the case.
And that's it.
Okay.
At.
Clamped down on the enrollment rate.
Over half of that COVID-19, which of course, we want to do and we've had good results.
So I just can't.
Predict precisely I know that we think that after September.
We will be able to ramp up some more and have those patients come in I think as you saw in.
April release on six safety.
Patients in the safety review.
Okay.
Although those didn't go over the.
The third cohort, which is the two those two.
Segment.
We've had good results in the feedback I get is that the.
Yes.
Like this particularly drugs so.
It's hard to say.
We're quite a bit of ways, there, we only need about.
Seven more patients six patients.
We will see which would you say that the circle horse to start cohort is enrolling faster than the first and second cohort.
No. It just started earlier so okay.
I guess the feedback for example, the untreated.
The bar is higher with that but we.
Enrollments have added RPI, so like that combination that tripled.
Regarding the.
Phase one trial of <unk>, one or two.
<unk> lymphoma.
Do you still expect to expect the trial to report data in the second half of this year.
I don't.
It's hard.
Enrollment has been slower.
We've enrolled and treated a patient with <unk>.
We have with that and in fact.
Looking at increasing.
The number of sites.
The FDA makes you start out.
At a low dose of 20 milligram per square meter and what we're getting back from P is as it.
It's tough.
And colleges to enroll.
<unk> that needs help.
And a dose that's.
At the low end.
Do a safety escalation. So we're working right now to see how we can increase that enrollment rate adding.
Adding adding side clearly one of the message messages so.
Frankly, I can't say.
With positivity that.
We will be able to report that first level, if we do.
<unk>.
I would not think it was would be anything that really reports on that.
Not at 20 milligrams per square meter.
It would be.
There weren't any kinds of safety related events.
Got it and lastly, the phase one trial in solid tumor with prestige burst in dash eight.
The trial is starting in the current quarter right.
That will start.
That will start in this current quarter that we're in.
And two.
To that we have been.
Finishing up our <unk> deal.
Solid tumors, which is the Brexit tuberous in batch.
And don't forget.
The <unk> zero zero too.
And refractory.
Relapse.
AML patients and that would also and you'll hear something fairly soon on that.
Oh that when they starting to as well okay.
Got it.
You'll hear something we havent put given an update on it but youll see something fairly quickly.
Okay got it thank you.
Youre welcome.
Thank you next question comes from the line of Laura Engel of Stonegate Capital Partners. Your line is open.
Good morning, Hi, Peter how are you.
Find Laura.
Good and thank you for that.
Uh huh.
Your line is.
Our barring anything.
Any problems from Covid.
Any problems from the.
The back issues could you give us just general expectations for levels of R&D expense second half of the year as compared to maybe first half given that first half was.
Fairly low versus you know my personal expectation.
Yeah remember.
As we've talked before R&D expense for US is one of the major drivers.
For us as drug brand drug product being a matter of fact I would expect in the second half that that will start to go up.
I have more batches.
I had one that's going through and I think I've indicated.
<unk> would be expected to be fully released by the end of the.
In September.
That of course will lead.
Release.
Any additional invoicing and expenses that come in.
As well as you'll notice on the balance sheet, we ended at $300000.
The increase in AR.
And drug product for testing and again, that's for our accounting.
We take a GMP related expense.
For the drug.
And accumulated as essentially a prepaid and Brian when we finally, when we finally get it.
Finished completed and released to us.
Then it drops it is expense.
Inventory that has a resale value so which once you take it you need to expense at all so that's a good example of it I've got another.
Drug batch that was got it started in July.
I'll go through its cycle.
Should be released to us.
December so thats, another and that was a double back.
So that's I expect it to go up.
And it would be reflective of.
Our pipeline.
Pipeline getting.
To back up.
Right Okay.
Great. Good first half of the year, great cash balance looking forward to the second half of the year and I'll get back in the queue. Thank you Sir.
Well thank you.
Thank you there are no further question at this time I would like to turn the call back to Peter Nielsen for closing remarks.
Thank you again, everyone for joining us and for your continued support.
<unk> holdings.
Have a great day.
Ladies and gentlemen, this concludes today's conference call. Thank you for participating you may now disconnect.
Good day.
[music].
[music].
[music].
Good morning, ladies and gentlemen, and welcome to the bio path Holdings second quarter 2021 earnings conference call. At this time, all participants are in a listen only mode.
Following the formal remarks, we will open the call up for your questions.
I would now like to turn the call over to will O'connor of Stern Investor Relations. Please proceed.
Thank you operator.
Welcome to the bio path Holdings conference call and webcast to review the company's second quarter 2021 financial results and an update on recent pipeline and corporate developments earlier, we issued a press release, which outlines the topics that we plan to discuss on today's call. It releases available at bio path holdings that cotton.
With me today from bio path are president and CEO, Peter Nielsen and senior Vice President of Finance Accounting Administration Anthony price.
We will begin the call I'd like to remind you that today's discussion will contain forward looking statements that involve risks and uncertainties. These risks and uncertainties are outlined in today's press release and in the company's recent filings with the Securities and Exchange Commission, which we urge you to read.
Our actual results may differ materially from what is discussed on today's call.
With that I'll now turn the call over to bio paths CEO Peter Nielsen.
Thanks will.
Good morning, everyone and thank you for joining us.
The first half of 2021 was very productive for bio path and I'm pleased to provide an update on our recent progress.
Over the course of the last six months, we have made meaningful progress in our pursuit of delivering or a portfolio of targeted new quake cancer drugs to patients in need.
I'll begin with our lead product candidate practices Jefferson.
We continue to make significant progress advancing stage two of our phase II clinical trial of practices you person for the treatment of acute myeloid leukemia.
Or AML in combination with frontline therapy decided in banana plaques.
As we have previously reported phase II clinical development of practices you burst in AML.
With stage one of the phase II clinical trial, which was open label untreated de Novo AML patients with a combination of practices, you berson and low dose cytarabine or <unk> the <unk>.
Combination of fractions of person at <unk> was shown to be safe and more efficacious to treat this class of patients than with <unk> alone.
As many of you know there has been an evolving landscape for standard of care and Annabel.
Despite these therapies there are still patients who are refractory or resistant.
Those are the patients we aim to help our.
Standard of care evolves, we adapted our trial design to reflect these changes.
The amendment stage two of this phase II trial in AML is an open label phase II two stage Multicenter study.
Your person in combination with decitabine in vanilla clacks in two cohorts of patients with previously untreated AML.
And relapsed resistant AML.
A third cohort includes treating relapsed resistant AML patients, who are vanilla clacks resistant or intolerant with the two drug combination practices your berson and decitabine.
The final trial design plans have approximately 54 evaluable patients for the cohort treating relapsed refractory AML patients with the triple combination treatment practices your birth and decided that in banana clacks and the cohort treating AML patients who are banana class resist.
Or intolerant with the two drug combination of practices you Berson and decided then with a review of both cohorts performed after 19 evaluable patients.
The full trial design plans have approximately 98 evaluable patients with it.
Cohort treating untreated AML patients with the triple combination treatment of <unk> decitabine in banana clacks.
With a preliminary review for the cohort performed after 19 evaluable patients at a formal interim analysis after 38 evaluable patients.
The higher number of patients in the full trial design for the untreated AML patient cohort is due to the higher baseline response of the frontline therapy with previously untreated AML patients.
The primary endpoint for this study will be the number of patients who achieved complete remission, which includes complete remission with incomplete hematologic recovery and complete remission with partial hematology recovery.
An interim analysis will be formed on each cohort to assess the safety and efficacy as a treatment.
In the second quarter, we were excited to announce the successful completion of the safety run in of the stage two of the phase two and we look forward to advancing this study as we believe its unique design provides us with several definable registration pathways.
Next I'd like to turn to our plan to phase one clinical trial of practices. The boroughs of dash eight in patients with advanced solid tumors, including ovarian and uterine pancreatic and hormone refractory breast cancer.
Praxis diverse and dash a fourth bio path drug candidate is a modified product complexity growths in sharing the same drug substance with enhanced nanoparticle properties.
This trial will be conducted at several leading cancer centers and is planned initially to evaluate the safety of practices your burleson in solid tumor patients.
Patients diagnosed with recurrent ovarian and endometrial cancer, often have poor outcomes and it is our hope that <unk> may provide clinical benefit for such patients.
Turning now to BP 1002, our second therapeutic candidate, which targets Bcl two.
As you know Bcl two is responsible for driving cell survival and up to 60% of all cancers high expression of Bcl two has been correlated with poor prognosis for patients diagnosed with AML.
<unk> has also shown activity against anti apoptotic protein Bcl, two and works by neutralizing the protein's BH III domain.
It is an improved treatment for chronic lymphocytic leukemia, or CML patients and untreated AML patients. However, with the exception of some patients treated with I looked and edited hematopoietic cell transplantation disease relapse invariably occur.
Oftentimes due to <unk> domain mutation over time.
<unk> 002 also targets the Bcl two protein.
However, P. P 1002 activity is based on blocking the Bcl two messenger RNA and not the big three domain.
As a result, we believe that BP was 002 could provide an alternative for <unk> patients, who have relapsed, including AML patients, who previously received <unk> treatments.
In a phase one trial refractory relapsed CML patients, including those who have failed or relapsed from banana clack spaced frontline therapy as well as refractory relapsed lymphoma patients are being treated with BP 100 to this trial is being conducted.
Several cancer centers.
We expect to initiate a phase <unk> clinical trial of BP 1002 in refractory relapsed AML patients to be conducted at several leading cancer centers in the United States, including the Wild Medical College of Cornell University, and the University of Texas.
M D Anderson cancer Center.
In the AML trial initially a total of six evaluable patients are scheduled to be treated with BP 1002 monotherapy in a standard three plus three design with a starting dose of 20 milligrams per square meter.
The approved treatment cycle is.
There's two doses per week over four weeks, resulting in eight doses administered over 28 days.
The phase I B portion of the study will commence after completion of BP 1002, monotherapy cohorts and we will assess the safety and efficacy of <unk> 002 in combination with decitabine in refractory relapsed AML patients.
Finally, let me briefly review progress we've made with our third drug candidate VB 1003, which targets the stat III protein.
This program has shown promising preclinical data and we are very excited for the future of this program.
We are studying VB 103.
For the treatment of pancreatic cancer in a patient derived tumor model.
Previous models have shown the drug to successfully penetrate pancreatic tumors and enhance the efficacy of standard frontline treatments.
We are particularly excited to launch our first in human validation of this cutting edge therapy in an especially challenging cancer indication that has limited treatment options. We are aiming to file an IND application with this very promising product candidate later in 2021.
Or 2022.
In June we announced that the United States patent and trademark office has granted a new patent relating to our BP 1003 program.
The new patent builds on earlier patents that have been granted that protect the platform technology.
<unk> D enable EIS.
As I have said before we continue our efforts to build a fortress of protection around our technology as it safeguards our platform technology and target specific technology as a deterrent to would be competitors and creates value around our core competencies.
With that I'll now turn the program over to Anthony price for a brief review of our second quarter 2021 financials, along with balance sheet highlights Anthony.
Thanks Peter.
The company reported a net loss of $1.8 million or 26 cents per share for the three months ended June 32021.
Compared to a net loss of 2.0 million or <unk> 55 per share for the three months ended June 30th 2020.
Research and development expense for the three months ended June 30th 2021 decreased two point.
<unk> 8 million compared to 1.0 million for the three months ended June 30th 2020, primarily.
Primarily due to timing of activities related to our clinical trials for BP 1002 in lymphoma.
<unk> senior person in AML and prestige personal dash eight in solid tumors.
General and administrative expense for the three months ended June 30th 2021 were 1.0 million consistent with the comparable period in 2020.
As of June 32021.
The company had cash of $28.1 million compared to $13.8 million at December 31, 2020.
Net cash used in operating activities for the six months ended June 30th 2021 was $4.2 million compared to 6.0 million for the comparable period in 2020.
Net cash provided by financing activities for the six months ended June 32021.
$18.6 million.
I'll now turn the call back over to Peter.
Yeah.
Thanks Anthony.
We entered the back half of 2021, and a stronger position than ever to advance our DNA <unk> platform in a number of important cancer indications.
We have a clear path ahead and are looking forward to generating the data to support our product candidates and to bring new treatment options to cancer patients waiting for breakthroughs.
With that operator, we are ready to open the call for questions.
Thank you and ask you reminder, if he would like has a question. Please press Star then the number one on your telephone keypad. Our first question comes from the line of E. Chan of E. C U E.
T U Wainwright your line is open.
Hi, Thank you for taking my questions.
Could you comment on whether the evolving pandemic is affecting b enrollment speed.
Peck senior person.
Trials in AML.
Aye.
They have not.
Had anything reported to be <unk>.
<unk>.
In that context.
Part of our enrollment if you recall.
We have active.
The manage the enrollment rate.
Our.
Drug supply.
At the end of last year.
We had a we lost a double batch due to a supplier having a COVID-19 outbreak.
And then following that the replacement double batch.
Had a plant malfunction, so it's kind of.
Anything is possible in this COVID-19 environment, we're now experiencing and having our.
First batch and recovery.
It'll be delivery delivered in about 30 days and then we have more after that so we should be.
Ramping up quite a bit we've continued treating an enrollment the whole time.
I am concerned as I'm sure everyone is about.
About.
What's going on with Covid and.
Our patients as you know are immuno compromised.
Uh huh.
The Covid area Thats out there is a deadly so.
But at this point I mean, we've just had some some patients enroll in AML. So it's a good question good thinking we watch it.
But so far.
Yes.
Halted R R.
Greatly reduce dark pool enrolled.
Enrollment okay.
Yeah.
The SEC cohort with Roche.
Relapsed refractory AML patients do you.
Kim.
Reached 19 Evaluable patients for entering a review by the end of this year.
Well previously I felt that was the case.
And.
Okay.
Clamped down on where enrollment way where over half of that.
19, which of course, we want to do and we've had good results. So I just can't.
Predict precisely I know that we think that after September.
We'll be able to ramp up some more and have those patients come in and I think as you saw that.
Accrual release on the six safety pace.
Patients in the safety review.
Although those didn't go over the.
The third cohort, which is the two dose toothbrush.
Segment.
We've had good results and the feedback I get is that the pie.
Like this parts of tourism drugs so.
It's hard to say.
Uh huh.
Quite a bit of ways, there, we only need about.
Seven more patients six patients.
We will see what would you say that the circle the circle, what isn't growing faster than the first and second cohort.
No. It just started earlier so okay.
I get that feedback for example, the untreated.
The bar is higher with that but we get the enrollments have added rpi's liked the combination that triple in untreated.
Regarding the.
Phase one trial of <unk>, one or two.
Promos are do you still expect to expect the trial to report data in the second half of this year.
Yeah.
No I don't.
It's hard.
Roland has been slower.
We've enrolled and treated a patient.
The problem, we have with that and in fact.
Looking at increasing.
The number of sites.
The FDA makes you start out.
At a low dose 20 milligram per square meter and what we're getting back from P eyes.
It's tough for oncologists to enroll.
Patient that needs help.
And a dose that's at the low end you know as you do a safety escalation. So we're working right now to see how we can increase that enrollment rate, adding adding site clearly one of the message messages. So.
Frankly.
Can't say.
With positivity that.
We will be able to report that <unk> level.
Level, if we do.
I would not think it was would be anything that really.
Ports on 'twenty.
<unk> 20 milligrams per square meter.
It would be.
Weren't any kinds of safety related events.
Got it and lastly, the phase one trial in solid tumor with perhaps each person dash eight.
The trial is starting in the current quarter right.
That will start.
That will start in this current quarter that we're in.
And to do that we've been.
Initiating up are ideal.
Solid tumors, which is the Brexit tuberous in batch and don't forget.
The BP 100 too.
And refractory.
Relapse.
AML patients.
And that one also in Europe.
Here's something fairly soon on that.
I hope that when they are starting to as well okay.
Got it.
Yes, you'll hear something we havent put given an update on it but youll see something fairly quickly.
Okay got it thank you.
Youre welcome.
Thank you next question comes from the line of Laura Engel of Stonegate Capital Partners. Your line is open.
Good morning, Hi, Peter how are you.
Fine Laura.
Good and thank you.
Just wanted to.
Your line is.
Barring anything.
Continuing problems from Covid.
Continuing problems from.
The bat issue could you give us just general expectations for levels of R&D expense second half of the year as compared to maybe first half given that first half was fairly low versus you know my personal expectation.
Yes, I remember.
As we've talked before R&D expense for US is one of the major drivers.
For us as a drug brand drug product being a matter of fact I would expect in the second half, but that will start to go up as I have more batches.
I had one that's going through and I think I've indicated would be expected to be fully released by the end of the.
Or.
September.
That of course will lead.
Lee release.
Any additional invoicing and expenses that come in.
As well as you'll notice on the balance sheet, we had the $300000.
The increase in AR.
Drug product for testing and again, that's for our accounting.
We take a GMP related expense.
For the drug.
And accumulated as essentially a prepaid and Brian when we finally, when we finally get it.
Finished completed and released to us.
And then it drops it is expense.
Not inventory that has a resale values. So once once you take it you need to expense at all so that's.
That's a good example of it I've got another.
Drug batch that was got it started in July.
Go through its cycle.
Should be released to us.
December so that's another and that was a double back and.
So that's I expect it to go up.
And it would be reflective of our.
Pipeline getting.
Pushed it back up.
Right, Okay, well, great. Good first half of the year, great cash balance I am looking forward to the second half of the year and I'll get back in the queue. Thank you Sir.
Well thank you.
Thank you Gary No further question at this time I would like to turn the call back to Peter Nielsen for closing remarks.
Thank you again, everyone for joining us and for your continued support.
Bio path holdings.
Have a great day.
Ladies and gentlemen, this concludes today's conference call. Thank you for participating you may now disconnect.
Good day.