Q1 2021 Bio Path Holdings Inc Earnings Call
Thank you for your patience.
Please stay on the line for the next available operator.
[music].
Thank you for your patience.
Please stay on the line for the next available operator.
Yeah.
[music] zone.
Thank you for calling the to go on for inside of the number please.
In August.
By the zero six for zero of three 7%.
Yeah.
I'm, sorry could you repeat that workpiece, Chris I can barely hear you.
By the 0640 of three seven.
Okay. Thank you and may of the spelling of your first of all of last name.
David Brown.
Okay.
Adjusted the.
Like the color of Brown, who is that correct.
Yes right.
And how about your name doesn't even for a company.
IRA a I E R. A.
Yes.
Okay. Thank you for your line of placed on hold on until the cockpits against.
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.
2021 is off to a terrific start.
Mark by substantial progress across our portfolio of targeted nucleic cancer drugs.
We are excited by the advances we've made but are even more excited by what is to come for bio path.
Let me now turn to discuss these advances on opportunities in greater detail.
I'll begin with our lead product candidate Brexit Your Burson, where we continued to make solid progress.
In April we were delighted to publish an analysis highlighting the potential of Brexit your burleson within the antisense oligonucleotide drug delivery landscape in.
In the peer reviewed journal bio medicines.
In addition stage two of our phase II clinical trial of Brexit you Bruce for the treatment of acute myeloid leukemia or AML in combination with frontline therapy decided of venetic Lax continues.
As we have previously reported phase two clinical development of Brexit you Bruce in the AML commit.
Commenced with stage one of our phase two clinical trial.
Which was open label untreated de Novo AML patients with a combination of Brexit you Bruce in the low dose cytarabine or <unk>.
The combination of Brexit, you Berson and L back 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 new therapies.
Still patients who are refractory or resistant and those of the patients we aim to help.
As standard of care evolved we adapted our trial design to reflect these changes.
The amended stage two of this phase II trial in AML is an open label phase II to stage of Multicenter study of Brexit, you, Bruce and in combination with decitabine, and but that of class 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 class resistant or intolerant with the two drug combination of Brexit, you berson and decided of it.
The full trial design plans of approximately 54 evaluable patients for the cohort treating relapsed refractory AML patients.
For the Triple combination treatment of Brexit, you, Bruce and decided of bin and genetic lax and the cohort treating AML patients who are vanilla clacks resistant or intolerant with the two dose combination of Brexit you're bearish on that side of it with a review of both cohorts performed after 19 evaluable patients.
The full trial design plans have approximately 98 evaluable patients for the cohort treating untreated AML patients with the triple combination treatment of Brexit your bursts of decided on in banana clocks with a per crew.
Preliminary the.
The review of the cohort performed after 19, evaluable patients and a formal interim analysis after 38 evaluable patients.
The higher number of patients on the older 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 hematologic recovery.
An interim analysis will be performed on each cohort to assess the safety and efficacy of the treatment.
In April we were excited to announce the successful completion of the study run in of stage two of the phase two which had a clean side effect profile and the lack of toxicity.
We are also very encouraged by the efficacy signal as shown in this dataset with five of the six evaluable relapsed refractory and newly diagnosed AML patients demonstrating clinical activity.
We look forward to advancing the study as we believe its unique design provides us with several definable registered registration pathways.
As I mentioned on our last call the United States patent and trademark office issued a third patent and our family of platform intellectual property that offers expanded defense of our D enable EIS platform technology.
In addition, we were pleased to receive the issuance of the patent related to Brexit you burst in combination with either.
Decided on the analog such as decided or the PCR able tyrosine kinase inhibitors does that nib and the lot of them.
This addition, further strengthens our intellectual property portfolio and completes our already granted patents.
New patents protect the unique therapy combination and supports our ongoing investment in this program to bring a new treatment option for patients with AML, who have limited treatment options.
As I've said before we will continue our efforts to build the fort for us of protection around our technology.
Is it the safeguards our platform technology and target specific technology, and as a deterrent to would be competitors, who and creates value.
Around our core competencies.
Next I'd like to turn to our planned phase one clinical trial of practices you person dash eight and patients.
With advanced solid tumors, including ovarian and uterine pancreatic and hormone refractory breast cancer.
Parts of your Burleson Dash, a fourth bio path drug candidate is a modified product from Brexit your borrowers from sharing the same drug substance with enhanced nanoparticle properties the.
This trial is expected to be conducted at several leading cancer centers and is planned initially to evaluate the safety of practices of burson in solid tumor patients.
Patients diagnosed with recurrent ovarian and endometrial cancer, often have poor outcomes and it is our hope that practices you Burson may provide clinical benefit for such patients.
Turning now to BP one the zeros are two our second therapeutic candidate, which targets Bcl two.
In April we presented a poster highlighting preclinical BP 1002 data at the 2021 American Association for cancer Research annual meeting.
The <unk> 002 targets the protein Bcl, two which is responsible for driving self survival in up to 60% of all cancers.
Hi expression of Bcl two has been correlated with poor prognosis for patients diagnosed with AML.
The data presented at the ACR poster show that the <unk> resistant cell are sensitive to the inhibitory effects of BP 1002, combined with decided the suggesting that this combination is the potential treatment for patients who have relapsed from frontline in the net aquatics based therapies.
<unk> has also shown activity against anti apoptotic protein Bcl, two and works by neutralizing the proteins ph three domain.
It is an improved treatment for chronic lymphocytic leukemia, or <unk> patients and untreated AML patients. However, with the exception of some patients treated with allo genetic hematopoietic cell transplantation disease relapse invariably occurs oftentimes do the BH III domain.
Mutation over time.
<unk> two also targets the Bcl two protein. However, <unk> 002 activity is based on blocking the Bcl two messenger RNA and not the BH III domain as a result, we believe the DP 1002 could provide an alternative for the.
And that of class patients, who have relapsed, including AML patients, who previously received vanilla clacks treatments.
Finally, let me briefly review the progress we've made with our third drug candidate <unk> 1003, which targets the staff III protein.
This program has shown promising preclinical data and we're very excited.
For the future of this program.
We are studying BP, one zero as of a free for the treatment of pancreatic cancer.
Patient derived tumor model.
Previous models have shown on 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.
Internet, especially on especially challenging cancer indication that has limited treatment options.
We are aiming to file and I and the application with this very promising product candidate later this year.
With that I'll now turn of the program over to Anthony price for a brief review of our first quarter 2021 financials, along with balance sheet highlights Anthony.
No.
Thanks, Peter the company reported a net loss of $2 4 million or <unk> 43 per share for the three months ended March 31, 2021, compared to a net loss of $3 3 million or <unk> 90 per share for the.
The three months ended March 31 2020.
Research and development expense for the three months ended March 31, 2021 decreased to $1 3 million compared to 2.0 million.
For the three months ended March 31, 2020, primarily due to decreased preclinical expense related to timing of activities for BP 100, <unk> III as well as decreased clinical trial expense due to timing of activities for a phase II clinical trial of Prexy giberson in AML and our phase one.
Clinical trial of <unk> zero two in lymphoma.
General and administrative expense for the three months ended March 31, 2021 decreased to $1 2 million compared to $1 3 million for the three months ended March 31, 2020, primarily due to decreased franchise tax expense.
As of March 31, 2021, the company had cash of $30 8 million compared to $13 8 million as of December 31, 2020.
Net cash used in operating activities for the three months ended March 31, 2021 was $1 6 million compared to $2 5 million for the comparable period in 2020.
Net cash provided by financing activities for the three months ended March 31, 2021 was $18 6 million.
With that I'll now turn the call back over to Peter.
Thanks Anthony.
As I hope we've conveyed on the call this morning.
Made great progress on 2021 that leaves us well positioned to achieve value, creating milestones throughout the balance of the year.
With our continued publication and presentation of data we are building of body of scientific and clinical evidence in support of our programs while greatly enhancing the visibility of our platform among relevant audiences.
My hope that with this the expanded knowledge of the potential of our D enable EIS platform.
We are building a groundswell of interest in our technology and the various ways. It can be used this.
This should enhance clinical trial enrollment business development efforts and more this is just the start and I couldnt be more excited about the future of bio path.
With that operator, we are ready to open the call for questions.
Yes.
And ladies and gentlemen, if you would like to ask the question at this time. Please press star followed by the number one on your telephone keypad. Please standby, while we compile the Q&A Ross day again, that's timeline.
And our first question is from the line of Jonathan Aschoff with Roth Capital Partners.
Yeah.
Thank you and congrats on the progress Peter can you give us any kind of update on the clinical data release timing for bricks and a one O O two.
Just particularly over the rest of this year on the first half of next year.
Yes.
Good morning, John.
Okay.
We are now.
You know I've been rebuilding my drug.
<unk> supply, we had of COVID-19 plant occurrence that the.
Pushed off of some of our batches so.
<unk> been managing our enrollment to the supply we have.
That will start ramping up.
Starting early next week.
So the batches plans for the end of the year.
With that being said.
I think that Oh.
Where over half the ways of one of them.
Towards 19.
Evaluable at one of the cohorts and the.
Theres a possibility we will get that readout by the end of the year of.
And certainly buy it.
I think the first half of the ball over the year.
B any remaining.
The remaining two cohorts, but we.
We had had pretty high response of the trading we were at one point of treating.
12% to 15 patients, so, but we needed to manage our supply so.
That's the current view, we've been getting good results.
You'll recall, what we put on the.
Six.
Valuable safety run out of patience.
The safety profile was excellent and.
We had the positive.
The efficacy enhancement over all of the various front.
Frontline treatments in the.
The three cohorts are it's just.
Obviously, it's a small data set.
That's the view I have right now.
Peter what cohort is the most enrolled what's the true.
The 91.
Currently.
The third cohort with the banana clacks intolerant resistant patients.
Okay, and then what's your biggest treatment landscape evolution concern the AML of that could possibly for a few to redesign the clinical path for <unk> again.
I'm not the.
Really the focus in that regard because of.
So whatever the.
The thing that.
The way it's worked with for its a combination treatment. So we always suite of.
Adapt.
If there's a change in the <unk>.
Frontline.
That's typically the way people want us to.
Configure our treatment option and I think.
The net of classes settled in pretty much as.
As for the east treatments.
The main the main drug treatment that with the sad nib.
So I think we're well on the way.
The other thing is every time, we've done of treatment.
The comparison or development.
Pre clinically we always show an incremental efficacy benefit. So it's really just keeping track with the with what's going on on the frontline and I've I view that to be.
On a pretty stable thing right now certainly in our third cohort, where you have the sad nib.
In practice of your boroughs the sat in them alone is.
As the as the.
As the frontline for those patients and I think that's a relatively low bar for us So I'm anxious for us to try to get to that so I mean, that's kind of my view.
Thank you Peter.
Okay.
Our final question comes from the line of <unk> Chen with H C. Wainwright.
Yeah.
Hi, Thank you hi, Peter Thank you for taking my questions.
Could you tell us a current.
Enrollment status of the.
One of the promo and the CIO of trial.
For the what.
For the year.
The P P. The P P. One of them to call the current enrollment status.
That trial has had one evaluable patients enrolled in the.
And we're currently.
You know <unk>.
Looking at the other patients we have good cancer centers.
B D. One of the 002 of starting out slow on the problem is as you well know.
When you do of dose escalating study.
It's hard to get people started at the low end because of the oncologists will say well it's.
The safety trial and.
You can't expect a lot of.
Benefit at the low I mean, we're starting at 20 milligrams per meter squared. So you have to kind of struggled through those those early phases. So we're looking to do that but we have had very.
Positive responses from our.
Sites that the.
Water participate we of M D Anderson, Georgia Cancer Center, and the Sarah Cannon.
We're all good the sites so we have three sites.
To do this dose escalating trial, so I think it'll get more rapid once we get up into the higher doses.
And do you believe this one trial can steal reported data before the end of this year.
Yes.
The cohort B and again the focus on the floor.
First one for example, three patients at 20 milligrams per square meter would be.
The first cohort it would be safety I don't know how much of efficacy.
You can the report on the early dose so it would go from <unk>.
2040, 60, or 90 or are those points.
It may go to 135, but I think those first for the ones that would be the principal focus so.
We certainly ought to be able to get one of those.
One of those the first cohort in.
Okay got it.
For a president of the person dash eight.
How quickly do you think the trial the phase one trial in solid tumor and recruit patients.
In the current environment tough dependent.
Well the there seems to be a lot of Oh.
This is this is gonna be a.
You know of treatment for solid tumors.
Net.
The systemic.
And.
Endometrial and the.
Advanced ovarian or.
One of them they can recruit and pancreatic we've done testing of that.
And so the.
The interest has been very high and you know we.
Ill begin the M D Anderson in that.
I recall, we are of a couple of others that the.
What would be coming in.
We are.
The weighted these extra four months of the FDA had asked us to do two more sets of testing and one of them was the.
<unk> in particular are hard for us.
Because of our product being a little bit different you have to do it on the drug product, which is reconstituted liposomes and so you have to.
For those you have to go through mechanisms to break down all of the liposomes and just get the bare particles on.
And some of them of the things you use.
To do that in the aggregate themselves and the.
And police and make the.
Make it a little more challenging but we in fact of now just got.
Got the word in the last week or two but the we've got that.
Tests successfully done and so on the F D a.
The.
December call, we had with them. The case just gave us the two things we needed to so I think we'll get our I N D here fairly quickly now.
The past is in and then.
There's a real need for this year and the.
We've had.
As you know we've had the.
Two ACR papers that have been well received posters.
At the annual meeting.
So.
I think there's a lot of interest in.
Getting the kind of treatment like this that and the health.
To help manage the obviously.
The first part of again will be.
The safety assessment, Fortunately since practices Burleson is.
It's the same drug so since the the formulation is different to get a better nanoparticle smaller particles.
But since that safety is out there with any of them now and we get the start of the higher dose I think at 60 milligram.
For the meter squared so.
You may not have to go through the hurdle of people not wanting to enroll our patients if they don't think they can get any benefit so.
I think we can maybe be better on that as well, but the.
The thing I know this is of this is of treatment that's really being looked for.
So we can expect this trial to be initiated in the third quarter.
Yes, and the.
I think we will get the R&D pretty quickly because we satisfied everything they want and the.
Once we get that I M D.
You opened up ready to go so certainly we.
We should be of dosing, our first patient on the third quarter for sure.
Got it thank you.
Yeah.
And thank you ladies and gentlemen.
The antibody of Q&A session I'd like to turn the call back over for any closing remarks.
Thank you again, everyone for joining us on for your continued support of bio path.
Of a great day.
Yeah.
[noise].
Ladies and gentlemen, this concludes today's conference call. The ex that you now disconnect your lines.
[music].
True.
[music].
Okay.
[music].