Q2 2020 Bio Path Holdings Inc Earnings Call
Ladies and gentlemen, good morning, and welcome to the bio path Holdings second quarter 2020, <unk> earnings Conference call.
At this time all participants are in a listen only mode.
When the formal remarks, we will open the call for questions to ask questions you will need to press star one on your telephone.
I would now let's turn the call over to Mr. will honor Stern Investor Relations. Please proceed.
Thank you operator welcome to the bypass Holdings conference call in Web cast your media company second quarter 2020 earnings results.
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 releases available.
Holdings Dot com.
With me today from Bob that's our President and CEO, Peter Nielsen and senior Vice President Finance Accounting administration Anthony price.
Before we begin I'd like to remind you that today's discussion will contain forward looking statements involve risks and uncertainties.
Risks and uncertainties are outlined in today's press release and in the company's recent filings with the Securities Exchange Commission, which are due to read our actual results may differ materially from what has discussed on todays call.
With that I'll now turn the call over to buyback CEO Peter Nelson.
Thanks, well.
Good morning, everyone and thank you for joining us today.
I hope this find you all staying safe and healthy.
This past month had been a challenge for us all and I'm proud to say that bottles have rolled up asleep.
And continued making progress advancing our key programs in our clinical development pipeline.
I'll begin with our lead product candidate parts of your berson.
Well, we have made substantial progress in recent weeks.
Yesterday, we were very excited to announce the dosing of our first patient in stage two of our phase two which is worse than for the treatment.
Acute myeloid leukemia or AML in combination with frontline therapy decided then and genetic watch.
As we've previously reported.
I used to clinical development approach to worsen in A.M.L. commenced with stage one of the phase two clinical trial.
Which was open label and treated at <unk> am adult patients with a combination approaches Robertson and logo site terrible held back.
The combination of perks members and held back was shown to be safe and more efficacious to treat this class of patients said with L. back alone.
As many of you know.
There has been evolving landscape.
Standard care and having a bell.
We were delighted with the recent progress that has been made.
But it's not enough.
Despite these new therapies, there are still patients who are refractory or resistant.
Those are the patients we aim to help.
A standard of care evolved we adapted our trial design to reflect these changes.
Feedback from treating physicians pointed to a preference for decided that.
The recent approval of frontline therapy that o'clock provided an opportunity for adding products the person who the newly approved frontline two drug combination of the never Clarkson decided wins for the treatment CML patients.
Prior to finalizing our plans, we performed preclinical testing an A.M.L. cancer cell lines to assess purchasing worsens increased benefit to Africa.
Preclinical testing of Frac scrubbers, and what the frontline treatment of decided that clocks demonstrated the potential to and hence advocacy of the frontline treatment combination.
In the studies for A.M.L. cancer cell lines were treated with three different combinations of decided been banana clocks and Brexit your berson.
Decreasing the M.L. cell viability was a primary measure of efficacy.
The triple combination of decide them in the medical acts and person to person showed significant improvement it efficacy in three or four A.M.L. cell lines.
Based on these results, we believe that adding Brexit your person to the treatment combination of decitabine and Veneta clocks could lead to improved efficacy in A.M.L. patients.
The amended stage two of this phase two trial well.
He is an open label phase two.
Two stage multicenter study of parts diversity in combination with decided that the kinetic wax and two cohorts of patients with previously untreated and AOL.
In relapsed resistant hey about.
The third Cohen.
Excuse me a third cohort includes treating relapse refractory AML patients.
Sure, but another clocks resistant or intolerant with the two drug combination approach to Burleson and decided.
The full trial by design plans have approximately 54 patients for the cohort treating relapse refractory AML patients with with the triple combination treatment or parts of your berson decided that are best in class and the cohort treating AML patients who are veneta clocks resistant and in Colorado.
With the two drug combination of Brexit your burleson inside of it with a review of both cohorts performed after 19 evaluable patients.
The full trial design plans have approximately 98 valuable patients for the cohort treating on.
Treated and meld patients with the triple combination treatment of Brexit Your Burleson decided that it's another KLAX was a primary view review.
For the cohort performed after 19.
The valuable patients and a formal interim analysis after 38 valuable patients.
The higher number of patients.
No problem design for the untreated AML patient cohort is due to the higher baseline response.
Frontline therapy.
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 partial hematology recovery.
And interim analysis will be performed on each cohort to assess safety and efficacy of the treatment.
India events. These results exceed the primary endpoint in a number of patients.
That meets or exceeds stick statistically determined threshold, we plan to seek to convert to trial into a registration trial for accelerated approval.
[laughter].
In May we were delighted to have Dr. Merrell had again.
Partner leukemia at University of Texas, MD Anderson Cancer Center present, a virtual poster presentation discussing this phase two trial design to an audience world leading oncologists.
We believe that this unique trial design provides us with several of the final registration pathways, we believe that Brexit your person with its promising efficacy and safety profile.
Has the potential to be an ideal combination candidate with frontline therapy.
Next I'd like to briefly touch on our planned phase one clinical trial prices Berson dash eight in patients with advanced solid tumors, including ovarian usually in pancreatic and hormone refractory breast cancer.
Brexit your person says Hey, <unk> fourth bio pad drug candidate is a modified product from Brexit your Bruce and sharing the same drug substance with enhanced nanoparticle properties.
Trial is expected to be conducted at several leading cancer centers and as planned initially to evaluate the safety of Brexit hubris in solid tumor patients.
Patients diagnosed with recurrent ovarian and endometrial cancer, often have poor outcomes and it is our hope that person to person may provide clinical benefit for such patients.
We filed an investigational new drug application Warner <unk> D.
And expect to begin the study in Twentytwenty.
Turning now to plans for BP, one owed to our second therapeutic candidate, which targets the bcl two protein.
Last year, we filed an eye in the application for our second pipeline candidate BP, One Oh too.
The net of KLAX has also shown activity against the Andy I'll hop coding.
Protein Bcl, two and works by neutralizing the proteins ph three domain.
It is an approved treatment for chronic lymphocytic leukemia, or CLL patients and untreated AML patients. However, with the exception of some patients treated with stem cell transplantation disease relapse invariably occurs often times due to be age three domain mutation overtime.
BP one or two also targets from C.L. King protein.
However, BP one or two activity is based on Fox the Bcl two messenger or are they adopted ph Street domain.
As a result, we believe that BP, one or two could provide an alternative for banana KLAX patients, who have relapsed, including AML patients, who previously we see veneta clecs treatments.
In November 2019, the F.D.A. granted us I and the clearance to study BP one owed to us it would be tensile three budgets for CLL, including Veneta, KLAX relapses and lymphoma.
We intend to file I knew I indeed.
To include A.M.L. relapses.
The plan to bottom application of our phase two clinical program are they a bell to include the another KLAX combination treatment.
With Brexit the Brooklyn will give us early experience with treating bcl two driven anti apoptosis in these patients we expect to begin our first in human study of BP one owed to in 2020.
In April.
We presented a poster at the American Association for cancer research or a CR.
Annual meeting highlighting the planned clinical trial design for a first in human phase one study.
DP 102 in patients with advanced lymphoid malignancies.
The phase one clinical trial is expected to be conducted at several leading cancer centers, including the University of Texas, MD Anderson Cancer Center, the Georgia Cancer Center.
Sarah Cannon Research Institute.
[laughter].
Finally, let me review our progress with our third drug candidate BP went over three which targets the statthree protein.
This program has shown promising preclinical data.
We're very excited for the future of this program.
We are studying BP, one or three for the treatment of pancreatic cancer patient derived tumor model.
Previous models have shown that the drug to successfully kind of creep pancreatic tumors and enhance the efficacy of standard frontline treatments.
The potential for our Statthree program is compelling for a number reasons.
Signal transduction activator transcription three were statthree.
So typically inactive in normal cells is aberrantly active in cancer cells.
The abilities of tumor cells to proliferate uncontrollably resist apoptosis or cell death.
Induce vascular formation and invade distance organs are well recognize hallmarks of cancer Statthree is a regulator of the genes involved in these cancer processes.
More recently the capability of tumors to evade immune surveillance and aboard destruction by the immune system has also gained significant acceptance in the cancer research field.
Statthree.
Which is a point of convergence for many oncogenic pathways.
Has emerged as a critical mediator tumor.
Evasion at multiple levels.
Activation of Statthree has been.
And in many types of cancers, including non small cell lung cancer and now in pancreatic cancer.
Activation of Statthree correlates with poor clinical outcome.
Hi, great disease, and metastasis and has been linked with resistance to chemotherapy.
Including Gem side, and then considered a standard of care agent for advanced pancreatic cancer.
Therefore inhibition make statthree in combination with seem chemotherapy is expected to produce enhanced clinical benefit.
Our preclinical data for this program highlighted for antisense Olga sequences directly to get Statthree Messenger are an eight identified by bio path and manufactured using DNA. The wise any sense are in AI nano particle technology.
Cell viability tests and western blocks flops were conducted to determine the inhibitory effects of liposome incorporated Statthree antisense oligo on non small cell lung cancer and a AML cells.
And ex vivo alive tissue sensitivity assets was performed with a panel of 20 pancreatic patient derived xenograft.
To study the overall activity of the BP 103 alone and in combination with Jim side of it.
Using previously this defined criteria tissue slice viability inhibition greater than 30% was a P value less than point Obi.
Counted as a response.
For debt validation of ex vivo results pancreatic cancer patient derived xenograft, so tumor bearing mice.
We are administered.
The 103 engine side of it twice a week for 28 days tumor volumes were monitored for up to 49 days.
In alive assay.
In the light tissue Asaib BP one whole three at a dose of 10 micro mower significantly inhibited the tissue slice viability in nine out of 18 pancreatic cancer patient derived xenograft by more than 30% P value less 0.5.
The combination of BP, one all three and Jim side of it further enhanced ex vivo advocacy NBP 103 in a subsidy subset of patient derived xenograft <unk>.
And the Nvvault study with pancreatic cancer patient derived xenograft models, a combination of BP 103, and Jim side of it caused tumor regression during the 28 day drug drug treatment period.
This anti cancer activity was maintained for another 21 days, even one drug treatment had ceased.
In addition, BP Wonho three was selected as the most book Liposome incorporated Statthree antisense sequence and decreasing non small cell cancer cell liability.
Further validation in AML cells demonstrated that BP, one or three inhibited cell viability and statthree protein expression.
He is very encouraging data were well received by the scientific community.
We are particularly excited to launch our first in human validation of these cutting edge therapy.
In especially challenging cancer indication that has limited treatment options moving forward, we are undertaking high India, enabling studies would be one all three this year.
The goal to file the idea application with its very promising product candidate later this year.
As you can see.
Despite the challenge we faced over the last several months Weve remained committed to driving forward our clinical development programs. During this challenging time.
We continue to make meaningful progress across our pipeline.
With that I'll now turn the program over the Anthony price for a brief review of our second quarter 2020 financials, along with balance sheet highlights Anthony.
Thanks, Peter the company reported a net loss of 2.0 million.
[laughter], who care for the three months ended June Thirtyth 2020, compared to a net loss of 2.5 million or 87 cents per share for the three months ended June Thirtyth 2019.
Research and development.
Three months ended June Thirtyth 2020 decreased to 1.0 million compared to 1.5 million for the three months ended June Thirtyth 2019.
Primarily due to timing of activities related to our phase two clinical trial Pepsi giberson in AML.
General and administrative expenses for the three months ended June Thirtyth 2020.
1.0 million consistent with the comparable period in 2019.
As of June Thirtyth 2020, the company had cash of 14.4 million compared to 20.4 million.
December 31st 2019.
Net cash used in operating activities for the six months ended June Thirtyth 2020 was 6.0 million compared to 4.2 million for the comparable period in 2019.
With that I will now turn the call back over to Peter.
Thanks Anthony.
The most ahead should be exciting as we head into the balance of the year.
We look forward to continuing to enroll stage two over phase two clinical trial.
This is your burleson to treat AML in combination with the now current standard of care and expect to show significant safety and efficacy.
Moreover, we think the addition of Brexit your person to this regimen will particularly important to those patients with relapsed or are we crossed front.
Another clecs and decided that.
In tandem with advancing this important program, we look forward to initiating our first human phase one program of CP, one or two.
The tree advance lymphoid malignancies.
Another oncologic indication that continues to lose current treatments.
So as you can see.
We have a number of key drivers as we advance our DNA mobilize technology in both.
Blood borne cancers and solid tumors.
[noise]. Thank you for your time this morning.
And as always we appreciate your continued support.
And encouragement.
With that operator, we're ready to open the call the questions.
Thank you.
Please note that today's conference is being recorded.
As a reminder to ask a question you will need to press star one on your telephone to withdraw your question press the pound or hash key.
Your first question comes from Laura Engel.
Stonegate capital partners.
Good morning, how are you guys.
Good morning, Laura.
So exciting I'm, especially about the doesn't Fran now get information with all of a one you mentioned it was touched on a last call and then you mentioned in the press. So it's just the challenges with.
Because of it and how that affecting clinical trials I wondered if you could just give us an update on that as far as.
Enrollment in a number of site, how it's affecting the patient in the trial.
And then I know you.
I have supply of the drugs for dosing, but how it might be affected not going forward as well.
Oh, several things there but.
We do have a.
Eight sites signed up for the A.M.L. trial going to 10, it's just two more the red the process. So we.
We reached our goal in that area to try to have more spots and rolling I know that.
Keysight Cornell has.
Lined up.
Several patients to start there.
Final stages of their Irve review.
So that seems fine, but the fact of the matter is.
And we've had enrollment so.
That third cohort, which is.
The intolerant genetic clocks and whatnot that's.
Derivative of the.
Previous amended cited.
The Brexit giberson.
Safety combination, which we continue to.
Eligible patient that needed roll the criteria will roll into that so we've had.
Patients and really have a head start on that cohort right now so.
Right now.
<unk>.
I haven't heard that were turned off I think were better than we were back was.
People were concerned about you know these are the income compromise to people.
Well concerned about traveling to the institution, but I think.
To be honest the one thing we have to look forward.
So look forward to be aware of is and I'm sure you've heard the.
CDC come out yesterday and talk about.
The fact that we're going back to school of course concerns about uptick in cases, but the confluence of that we'll see glue season.
He has made some pretty dire.
Projections.
Before Paul and.
I guess, we'll just have to see what happens on that and.
We're teed up.
Our suppliers are rule.
Excuse me.
Are performing.
And.
We had more graph drug batches being matter.
And deliberate.
So.
The hard part is just.
[laughter] predicting the the supply lines that you need.
Based on the right patient enrollments, so but the.
The response has been pretty good theres, a particularly in these relapsed patients.
There's.
Couple of those.
Cohorts I think represent real opportunities for us.
So we'll have we'll have to see but the biggest unknown to look for is.
What the world is going to look like at least in the United States in the September October November.
Right I wish we name.
Yes, I have [laughter].
[laughter] all in as well I appreciate it.
All right appreciate all the information to give us on the calls that uptick so.
He'll stay well and I'll get back into queue.
Thank you Laura.
Again, if he would like to ask a question. Please press star one.
Your next question comes from Yi, Chen with H.C. Wainwright.
Hi, Good morning, Peter Thank you for taking my questions.
My first question Hi, My first question is so among the for CLL cell lines test that preclinical study.
Oh, the Kazumi one cell line is there a particular.
Specific split nation.
Why is this cell line because performed well with the triple combination what percentage of maybe a male patients.
Patients.
So line represent real world.
I'm not sure the reason for the minimal response on that.
And I don't know what percentage. It is we just wanted to take a spectrum of these and they'll cells and Tesla.
As we indicated we had pretty good results and all but that one night in the previous studies I see.
It's not necessarily.
Circumstance that.
You go well across all cell lines and.
I can think of the.
Investigate that was Ana, but you know I ask about that it's just a sole ended the doesn't respond.
Okay.
Got it.
So for the in the final trial design the full trial design.
The there there will be 54 embedded with patients for the cohort of relapse refractory AML patients and the.
The though we need a class resistant patient group.
As a review of cohorts performed after 19, you're better patients does that mean.
About 50% up 19 patients have to come from each cohort or or it doesn't really matter as long as the total reach no no no no no that's.
Yes, that's for each cohort.
Well, that's where each cool, okay, yeah, and that's so.
The four patients for each cohort.
Except for though.
No. That's if you go the pool.
Trial, the ideas, we want to want to make an interim assessment because [noise].
I think back when we did.
When we first started this with L. that combination held back is.
7% to 13% response to complete remission.
And what we did that six patient.
Safety study to dose level, if you recall.
Yep.
The start of the phase two.
We had a 50% response.
See our response.
And then two more out of the six were parcels that had over 50% bone marrow blast reduction and so the point is.
If you get that kind of early on indication.
We would want to waste our time going through all 54.
We thought that would give us enough of a statistical just thinking about.
Amount of improvement versus the baseline CR rate.
To have a PR.
A P value strong enough to go to the FDA to make the case to switch to accelerate a trial. So in every one of those cohorts.
We want to do that assessment and get to the endpoint as quickly as we can.
Likewise.
Just I lose mentioned it [noise].
With the.
Untreated they have mill that frontline baseline is 60% the others are 20%.
So in your 60%.
At the kind of.
Statistical power that you need you would have to go.
Greater number of patients. So that's why but we're still going to look at 19 and see what we look like going up it looks a little we'll go to 38 to get the power D and if it's a it's a signal a meaningful increase will go to the FDA, but we would need 38 on that one just because again.
You're talking about the.
Response relative to 60% baseline so.
Presumably you'll be more for that power.
Yes, so just to confirm the total number of patients that would be rolled for all three cohorts Folly road would be 206 patients.
[noise], whatever rub 50, 454, and 90 to 98, yes, yes, Okay got it got it.
Okay. So this this trial design broadly presents a threed pathway to potential approval right does it yes. It does.
Okay.
Got it.
And my last question is on the financial side. So the second quarter operating expenses is meaningfully lower than the first quarter, but now since you have started those in patients in this.
Phase two trial.
With three cohorts shall we expect the upfront expenses to go higher starting from the sort of quarter.
Well you know a large part of our.
Operating expenses.
We're on.
Putting the infrastructure in place so think about going from six to eight.
Intense those are all those clinical documents.
We have to facilitate our COO does.
Facilitate review negotiation and sign off with all of those sites. So you have a quite a bit of see our own expense in that respect the other thing is.
As I.
Alluded to with Laura.
We've got to build our pipeline on the drug and with Us again.
When we finish our GMP material of those no market for that material. So we don't get sick inventory, we put it in prepaid and then once we get it released us it drops to the expense line.
So a lot of the.
A lot of the expenses that we've had.
First and second quarter had been as a result of gearing up.
I would take when you have your drug in place and you have your your clinical sites set up.
You know the patient costs, Yeah thats.
Something but you are consuming you consuming drug thats already been Expensed and so you know the incremental effects would be.
You know that the cost the patient cost that you have with a site when they.
You know enrolled patients those some and whatnot.
And the CR.
Continuing CRL expense for.
Continuing to monitor work, but.
It's not what you think could be step up from the plot the plateau or level of expenses established in the first and second quarter, because a lot of that startup, but wont be either.
So I think in the cash consumed area, which is the driver of our earnings.
We averaged 3 million this quarter and.
We should be in that three to three and a half.
Maybe if we have another build drug extends quarter its highest for but three to three and a half way because what I think we'd be looking ahead.
Okay got it thank you.
You're welcome.
I'm showing no further questions at this time I would now like to turn the conference back to Mr. Peter Nielsen.
Thank you again, everyone for joining us and for your continued support bio path had a great day.
Ladies and gentlemen, this does conclude today's conference call. Thank you for your participation you may now disconnect.
[music].