Q3 2020 Bio Path Holdings Inc Earnings Call
Good morning, ladies and gentlemen, welcome to the bio path Holdings third quarter 2020 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 Stern Investor Relations. Please proceed.
Thank you operator welcome to the bypass Holdings conference call on that cast to review the company's third quarter 2020 earnings growth.
Right and update on recent pipeline and corporate developments earlier, we issued a press release, which outlines the topics that we plan to discuss on todays call releases available bio Pedra holdings Dot com.
With me today from bypass, our president and CEO, Peter Nielsen and senior Vice President of Finance and accounting on administration Anthony price from.
Before we begin 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 bypass CEO Peter no.
Thanks will.
Good morning, everyone and thank you for joining us today.
This has been an exceptional year for bio path.
We have achieved several significant milestones.
Most notably the initiation of stage two other.
Our phase two study of Brexit Your person then say on Bell.
And we have done so in an unprecedented environment.
Well, we are still managing the impact of the COVID-19 on our lives on business.
I'm continually impressed by our team and their ability to definitely maneuver around the challenges weve been presented with.
As a result of their hard work.
We're in a very strong corporate position as we close out 2020 and enter 2021.
I'll begin with our lead product candidate flexing your boroughs.
Well, we continue to make meaningful progress.
In the third quarter, we closed we dosed the first patient.
In stage two of our phase two approaches you're burson for the treatment of acute myeloid leukemia.
Hey on Mel Inc.
Combination with front line therapy decided and sensor data class.
As we have previously reported.
Phase two clinical development of Brexit your person that I am now commenced with stage one other phase two clinical trial, which was open label and treated to know A.M.L. patients with a combination of Brexit your burleson and low dose cytarabine or held back.
The combination of park scrubbers on an L. day was shown to be sales and more efficacious to treat this class of patients them with L. DAC alone.
As many of you know.
There has been an evolving landscape for standard of care and Mel.
Despite these new therapies, there are still patients who are refractory or resistant.
Those are the patients we aim to help.
The standard of care evolves, we adapted our trial design to reflect these changes.
Feedback from treating physicians pointed to a preference for decided on.
The recent approval of frontline therapy is inadequate provided an opportunity for adding Brexit your person to the newly approved front line two drug combination of genetic blacks and decided for the treatment of previously untreated AML patients.
Prior to finalizing our plans.
Perform preclinical testing AOL cancer cell lines to assess Brexit your bruce's increased benefit the efficacy.
Preclinical trust testing of Brexit your person with the frontline treatment of decided but other than that of clackson demonstrated the potential to enhance efficacies other frontline treatment combination.
In the studies for A.M.L. cancer cell lines were treated with three different combinations of decided that the net o'clock and Brexit universe.
Decrease in A.M.L. cell viability was the primary measure of Africa. So.
The triple combination of decided on genetic Blackson plexus. Your Bronson showed significant improvement and efficacies in three of the four A.M.L. cell lines.
Based on these cell based on these results.
We believe that adding complexity to burst on to the treatment combination of decided that and phonetic lives could lead to improved efficacy.
AOL patients.
[laughter] excuse me yes.
The amended stage two of this phase two trial and they on though is an open label phase two two stage multi center study.
Next is your person in combination with decided and genetic lax in two cohorts of patients with previously on treated any on bell and relapsed resistance pay about.
The third cohort includes treating relapsed resistant AML patients, who are panetta KLAX resistant or intolerant.
The two drug combination of Brexit, your burleson and decided that.
The full trial design plans have approximately 54 evaluable patients.
For that cohort treating relapsed refractory AML patients with the triple combination treatment of price is your gross have decided that on banana clocks.
And the cohort treating a on meld patients who are banana clocks resistant or intolerant with the two drug combination of Brexit Robertson and decided with a review of both cohorts before after 19 evaluable patients.
The full trial design plans have approximately 98 valuable patients with a cohort treating untreated AML patients with the triple combination treatment of Brexit your burleson decide of and the net acquirer.
With a preliminary review for the cohort for follow on after 19, Evaluable patients and 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 on the front line therapy with previously untreated AML patients [laughter].
The primary endpoint for this study will be number of patients who achieved a complete remission.
Which includes a complete remission with incomplete hematologic recovery.
Complete remission with partial hematology recovery.
An interim analysis will be performed on each cohort to assess the safety and efficacy.
The treatment.
On the event these results exceed the primary endpoint in a number of patients that meets or exceeds statistically determine thresholds. We plan to seek to convert the trial into a registration trial for accelerated approval.
In October we announced that the United States patent and trademark office issued a notice of allowance for claims related to Brexit you Bruce and in combination with either cited died analog such as decided bid or bcr able tyrosine kinase inhibitors. This.
Sat net and Nilotinib.
The addition of further strengthens our intellectual property portfolio.
And complements already granted patient perhaps.
Our growing patent estate continues to be a valuable asset for bio path as it provides protection not only for our core product portfolio and research efforts, but now also offers brought protection Inc.
Combination with established front line therapies.
This new patent protected the unique therapy combination and supports our ongoing investment in this program to bring a new treatment option to patients with AOL, who have limited treatment options.
[noise] that's.
I'd like to turn to our planned phase one clinical trial.
Next is your Burson dash eight in patients with advanced solid tumors, including ovarian uterine pancreatic and the hormone refractory breast cancer.
Luxembourg Giberson Dash eight A. fourth bio path drug candidate.
He is a modified product from Brexit your boroughs and sharing the same drug substance with.
With enhanced nanoparticle properties. This.
This trial is expected to be conducted at several leading cancer centers and is planned initially to evaluate the safety of Brexit hubris on dash eight in solid tumor patients.
Patients diagnosed with recurrent ovarian and endometrial cancer.
Austin have poor outcomes and it is our hope that Brexit your gross index, a may provide clinical benefit for such patients.
We filed an investigational new drug application or I N D and remain on track to open the study by year end.
Turning now to plans for BP, one owed to our second therapeutic candidate, which targets Bcl two.
Last year, we filed an eye on D. application for a second pipeline candidate BP one old too.
The net KLAX has also shown activity against anti Alpha.
Total protein Bcl, two and works fine neutralizing the proteins be age 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 I love genetic share motto poetic.
Cellphones growth trend transplantation disease relapse in Berkeley occurred oftentimes due to be a street domain mutation.
Overtime.
BP 102 also targets Bcl two protein. However, you want to go to activity is based on blocking the bcl two messenger or a day and not to be age three domain.
As a result, we believe that BP one owed to provide an alternative for the net of KLAX patients, who have relapsed, including a on meld patients who previously received the data KLAX treatments.
In 2019, net Diego the FDA granted US line D clearance to study BP Watteau too as a potential treatment for CLL, including banana KLAX relapses and lymphoma.
We plan to file an eye on de to trial to treat am ehealth and other products.
Relapses with VB, one node to the plan modification of our phase two clinical programs and AOL to include than other clients combination treatment with Brexit your burleson well.
Well give us early experience with treating bcl two driven anti apoptosis in these patients.
We expect to begin our first in human study of VB, one or two in loans lymphoma CLL in the coming weeks.
Finally, let me briefly review the progress we've made with other third drug candidate BP 103, which targets the statthree protein.
This program has shown promising preclinical data and we are very excited for the future of this program.
We are studying BP one on three for the treatment of pancreatic cancer the patient.
Patient derived tumor model.
Previous models have shown the drug to successfully penetrate pancreatic tumors and enhance the efficacy of standard for front line treatments.
The potential for our Statthree program is compelling for a number of reasons.
Signal transduction, and activator of transcription free or Statthree.
So typically enacted in normal cells is aberrantly active cancer cells.
The abilities of tumor cells to proliferate uncontrollably resist on top ptosis or cell death.
Induce vasculature formation.
And invade distant organs are well recognized hallmarks of cancer Statthree is a regulator of the genes involved in these cancer processes.
Most recently the book capability of tumors to evade immune surveillance and avoid destruction.
On the immune system has gained significant acceptance in the cancer research field.
Stat free which is a point of convergence for many oncogenic pathways has emerged as a critical mediator of tumor immune evasion at multiple levels.
We are particularly excited to launch our first in human validation.
Of this cutting age their average therapy, and especially challenging cancer indication that has limited treatment options.
Moving forward, we are undertaking I, India, enabling studies for BP y O. Three this year with a goal to file on high and the application work is very promising product candidates.
2021.
With that I'll now turn the program over to Anthony price for a brief review of our third quarter 2020 financials, along with balance sheet highlights Anthony.
Thanks Peter.
The company reported a net loss of 3.0 million per 80 cents per share from the three months ended September Thirtyth 2020 per.
Compared to a net loss of 2.2 million or 78 cents per share from the three months ended September Thirtyth 2019.
Research and development expenses for the three months ended September Thirtyth 2020 increased to 2.0 million compared to 1.4 million for the three months ended September Thirtyth 2019 primary.
Primarily due to increased enrollment for our phase two clinical trial presage embarrassing in AML as well as increased preclinical study expenses.
General and administrative expenses for the three months ended September Thirtyth 2020 increased to 1.0 million compared to point 9 million for the three months ended September Thirtyth 2019.
Primarily due to increased franchise tax expense.
As of September Thirtyth 2020, the company had cash of $12.1 million compared to 20.4 million at December 30, Onest 2019.
Net cash used in operating activities for the nine months ended September Thirtyth 2020 was $8.4 million compared to 6.1 million for the comparable period in 2019.
Subsequent to September Thirtyth 2020.
Bio path issued 850000 shares of its common stock for gross proceeds of approximately 4.6 million.
Through our at the market offering agreement with H.C. Wainwright.
With that I'll now turn the call back over to Peter.
Thanks Anthony.
[noise], despite 2020 being a challenging year.
We've made considerable progress across our programs.
We look forward to continuing to enroll stage two of our phase two clinical trial of products through person to free pay on Mel in combination with the now current standard of care and expect to show significant safety and efficacy.
Moreover.
We think the addition of corrections your burson to this regimen will be particularly important for those patients who have relapsed or recalcitrant kinetic lax will decide on that.
In addition, we look forward to initiating our first in human Phase one program of BP wasn't bow to to treat advanced lymphoid malignancies. Another oncologic indication that continues.
Through a loop current treatments.
Before opening the call up for questions I'd like to take this opportunity to thank our dedicated team who have remained steadfast throughout the pandemic and who have continued to perform under these unique circumstances the.
The advances we have made and will make in the coming months are testament to the perseverance and professionalism Inc.
Importantly, we thank our loyal shareholders for your continued support as we advance these important programs.
With that operator, we're ready to open the call for questions.
Ladies and gentlemen, if you have a question or comment at this time. Please press Star then one on your telephone keypad.
If your question has been answered or you wish to remove yourself from the queue simply press the pound key.
Again, if you have a question or comment at this time. Please press Star then one on your telephone keypad.
We have a question or comment from the line of Yi Chen from H.C. Wainwright. Your line is open.
Hi, This is blue bar on dialing in for each one can you hear me okay.
Yes.
Okay. Thank you I don't know on boarding stated on your prepared remarks can you provide additional color on the enrollment progress for the page to try on especially we are in the midst of the rights and current on minus Capex.
I'm, sorry that last sentence. Please.
Especially in line.
In the middle of the rice, because we are in the right. That's going on on awareness cases are increasing so I was just curious on.
Are you on my tenure and drilling on progress yes.
Yes, yes, well.
COVID-19 issues that.
We look for.
Patient enrollment.
Uh huh.
You know as you know immune compromised patients.
On our very susceptible.
To advance the.
Problems if they go on taxi.
Slide 19.
And in particular, our patience a lot of them you know they they come to the institution traveled to it.
To all.
Received a treatment.
So you.
You know.
The day, our enrollment is actually.
Very good at this phase two.
And.
So.
I know you typically that means that you know I think some people seeing some other some benefits.
However, as we keep the.
I mean as these new cases go up.
It creates a risk your interest environment and so.
You know I can't tell you what it'll be like over the next couple of cases.
Months as we get into the into the winter.
So but for now.
We're not seeing.
That effect on enrollment second criteria you look for is.
As our suppliers and.
Yeah.
Kinds of things that can happen on that is.
Yeah, So you've got a shift.
Plant.
And with one person gets coded loans.
Oh shit hits quarantine, so even though that can be cleared up and in two or three weeks.
Of course it.
Kent effect.
The backlog.
So.
Your your batch.
B.
You know.
Manufactured.
334 weeks or months month, and a half down the line is one thing, but the fact is everybody else does that so you have qt effect, so that's something else.
We're going to have to keep an eye on floor, particularly since.
As you probably know.
Big pickup the cobot cases have now been through the Midwest. So.
But the.
So far so good.
That's clear thank you on I'm just a good from classification on this house patients being enrolled in each of the three cohort on deals on estimated timeframe. Then you will reach the 19 evaluable patients in each cohort. Thank you.
Well, it's just I mean, it's too hard to do that I can tell you that.
One other cohorts, we have over half of the patients and I think yeah I got it.
Cohort.
Hello.
Not far behind that so we are doing well so.
Certainly we don't have any catastrophes out the environment.
Oh, you know we could see.
Mid term valuations or at least.
Reaching on a threshold.
Next year.
So, but we'll have to wait and see if there's just a lot of variables out there that we don't control.
Got it on one final from me so when do you plan to start the phase one study for BP, One Peter too I think on <unk>.
Right.
Excuse me.
Say that again please.
When do you plan to start the phase one study of BP, one Peter get on <unk>.
Well, it's been you know we received dry and de last year.
Provided however, additional.
They wanted to some new testing.
I always want something and so we had to.
Develop some new tests going to validate and whatnot so were sales.
Were cleared on all of that and we're open and we think you'll hear some news on that fairly shortly.
That's it from me. Thank you so much.
Very welcome.
Thank you I'm showing no other questions on this call in the queue at this time I'd like to turn the call back over to management for any closing remarks.
[noise] Oh, thank you.
The [noise].
[noise] [noise]. Thank you again for joining us and for your continued support.
Bio path. We appreciate it very much have a great day.
Ladies and gentlemen, thank you for participating on todays conference. This concludes the program you may now disconnect everyone have a wonderful day.
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