Full Year 2020 Bio Path Holdings Inc Earnings Call
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Good morning, ladies and gentlemen, welcome to the bio path Holdings full year 2020 earnings conference call. At this time all the 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 on webcast to review the company's full year 2020 financial results and to provide 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. The release is available at bio path Holdings Dot com.
With me today from bio path of our President and CEO, Peter Nielsen and senior Vice President of Finance accounting and administration Anthony price.
Before we 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. Thank you for joining us.
I'm pleased to be addressing you all today to discuss the significant progress we made in 2020.
Which saw important advances across our clinical development pipeline.
Despite headwinds from COVID-19 pandemic the prop.
Yes, we made throughout 2020 form the foundation for us to advance and expand our clinical portfolio toward key inflection points in 2021 and it would be on.
We continue to execute on our clinical development plans.
Across our D enable EIS platform of innovative RNA nanoparticle therapeutics Peter.
Treat patients suffering with a variety of life threatening cancer indications.
Despite some groundbreaking progress with the immune.
You know oncology and combination therapies, there continues to be a large unmet medical need for a great number of cash of cancer patients.
I'll begin with our lead product candidate in parts of your birth of where we continued to make meaningful progress.
Last year, we dosed the first patient in stage two of our phase two of <unk>.
Thank you Bruce for the treatment of acute myeloid leukemia or AML in combination with the frontline therapy decided instead of net of class.
As we have previously reported phase II clinical development of the proxy of your berson and Anvil.
Minutes with stage one of the phase II clinical trial, which was open label untreated de Novo AML patients. So the combination of Brexit your berson and low dose cytarabine or held back.
The combination of practice of your births in the L back was shown to be safe and more efficacious to treat this class of patients than with L. DAC alone.
As many of you know.
There has been an evolving landscape for standard of care in AML.
Despite these new therapies the.
Still patients who are refractory or resistant and those are the patients we aim to help.
As standard of care evolves, we adapted our trial design to reflect these changes.
Feedback from treating physicians pointed to a preference for decided of the.
The approval of frontline therapy, Venetic clacks provided an opportunity for adding Brexit your person to the newly approved frontline two drug combination of genetic lax and decided that for the treatment of previously untreated AML patients.
The amended stage two of this phase II trial in AML is an open label phase two two stage multicenter study of practicing supers and in combination with the side of it and venetic wax in two cohorts of patients with previously untreated AML and relapsed resistant AML.
<unk>.
The third cohort includes treating relapsed resistant AML patients, who are vanilla clacks resistant or intolerant with the two drug combination of proxy of your berson and decided it.
Before the trial design plans have approximately 54 evaluable patients for the cohort treating relapsed refractory AML patients with the triple combination treatment of practice of diverse and decided that of clocks.
And the cohort treating AML patients, who are vanilla clacks resistant or intolerant with the two drug combination of practices, you berson and decided the wood.
The 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 the person decided the banana classics with a preliminary review for the cohort performed after 90.
17, Evaluable patients had a formal interim analysis after 38 evaluable patients.
The higher number of patients in the trial design for the untreated AML patient cohort of students of 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.
And the interim analysis will be performed on each cohort to assess safety and efficacy of the treatment.
The event these results exceed the primary endpoint in a number of patients that meets or exceeds statistically determined the thresholds we plan to seek to convert the trial into a registration trial for accelerated approval.
In February we you know, we announced that the United States patent and trademark office issued a third patent in our family of platform intellectual property that offers expensive defense of our D enable EIS platform technology.
In addition, we were pleased to receive the issuance of a patent related to Brexit your burleson in combination with either a cytokine analogue such as decided or.
Or the PCR able tyrosine kinase inhibitors, the sat in the law and the debt.
This addition, further strengthens our intellectual property portfolio.
Complements our already granted patents.
Our growing patent of state of 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 broad protection in combination with established frontline therapies.
These new patents to protect the unique therapy combination and supports our ongoing investment in this program to bring a new treatment option to patients with AML, who have limited treatment options.
As I have said before we will continue our efforts to build of fortress of protection around our technology.
As it safeguards our platform technology and target specific technology ease of deterrent to wood.
It would be tough competitors and creates value around our core competencies.
Next I'd like to turn to our planned phase <unk> clinical trial of <unk>.
Each of burst in batch a in.
Patients with advanced solid tumors, including ovarian and uterine pancreatic and hormone refractory breast cancer.
The proxy diverse and dash a force bio path drug candidates.
Modified product from Brexit your bursts of sharing the same drug substance.
With enhanced nanoparticle properties.
This trial will be conducted of several leading cancer centers.
And is planned initially to evaluate the safety of Brexit you Burson in solid tumor patients.
Patients diagnosed with recurrent ovarian and endometrial cancer, often have poor outcomes and it is our hope the practice of tuberous in may provide clinical benefit from such patients.
Turning now to <unk> 002, our second therapeutic candidate, which targets Bcl two.
Last year, we filed an IND application for our second pipeline candidate <unk> one 002.
The net of class has also shown activity against the ante up on the topic protein Bcl, two and works by neutralizing the proteins <unk> 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 allo genetic hematopoietic cell transplantation.
Disease relapse invariably incurs oftentimes due to <unk> domain mutation over time.
The <unk> 002 also targets the Bcl two protein however.
However, the P. One 002 activity is based on blocking the Bcl two messenger RNA and not the BH the rebuild Inc.
As a result, we believe the BP one 002 could provide an alternative for <unk> patients, who have relapsed, including AML patients, who previously received net of clocks of treatments.
Finally, let me briefly review the progress we've made on our third drug candidate BP 100, free which targets the stat three protein.
This program has shown promising preclinical data and we are very excited for the future of this program.
We are studying <unk> 003 for the treatment of pancreatic cancer.
On the patient derived tumor model.
Previous models have shown on the drug to successfully penetrate pancreatic tumors and enhance the efficacy of standard frontline treatments.
The potential for our staff III program is compelling.
On a number of reasons.
Signal transduction, and activator of transcription three or step three the.
Typically inactive in normal cells is admirably active in cancer cells.
The abilities of tumor cells to proliferate uncontrollably.
Resist apoptosis or cell death.
Induce vascular formation and invade distant organs are well recognized hallmarks of cancer.
Statutory as the regulator of the genes involved in these cancer processes.
More recently, the capability of tumors to evade immune surveillance and of.
Boyd destruction by the immune system.
He has also 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 edge therapy in an especially challenging cancer indication that has limited treatment options.
We are aiming to file an island the application with this very promising product candidate later this year.
With that.
I'll now turn the program over to Anthony price for a brief review of our full year 2020 financials.
Along with balance sheet highlights Anthony.
Thanks Peter.
The company reported a net loss of $10 9 million or $2 83 per share for the year ended December 31, 2020, compared to a net loss of $8 6 million or $3 24 per share for the year ended December 31 2019.
Research and development expense for the year ended December 31, 2020 increased to $6 6 million compared to $4 6 million for the year ended December 31st 2019.
Primarily due to increased enrollment for our phase II clinical trial of <unk> in AML.
The startup costs related to the phase one clinical trials for BP, One 002 and the farmer.
Prexy giberson, a in solid tumors.
And increased preclinical expenses for BP 100 free.
General and administrative expense for the year ended December 31, 2020 increased to $4 3 million compared to $4 1 million for the year ended December 31, 2019, primarily due to increased franchise tax expense.
As of December 31, 2020, the company had cash of $13 8 million compared to $20 4 million at December 31, 2019.
Net cash used in operating activities for the year ended December 31, 2020 was 11.0 million compared to $8 4 million from the comparable period in 2019.
Net cash provided by financing activities for the year ended December 31 2020.
It was $4 3 million.
With that I'll now turn the call back over to Peter.
Thanks Anthony.
I'd like to leave you today, where the few thoughts on the imperative bio path has bringing our D enable EIS products to market.
According to the American cancer Society more than 600000 people lose their lives the cancer each year.
During the COVID-19 pandemic cancer patients are among our most vulnerable populations.
This is why we of bio path continue to be relentless in our pursuit to bring better treatment options for these patients so desperately need them for whom there are no treatment options.
I'd like to take this opportunity to express my gratitude to the bio path team and the researchers and position supporting our scientific and regulatory advancement.
Because without their collaboration and support we could not have made the progress we have made to date.
We look forward to advancing together to secure our future success.
With that operator, we're ready to open the call for questions.
Okay, ladies and gentlemen, if you have any questions at this time. Please press the star and then the number one key on your Touchtone telephone.
If your question has been answered or you wish to remove yourself from the queue. Please press the pound key.
Yes.
The first question is from the line of E Chen with H C. Wainwright.
Hi, Thank you for taking my question. My first question is could you tell us.
Which arm of the AML trial.
The <unk> patients faster than the others and weather.
This is likely to report into the data before the end of the thank you.
All of my expectation is that the third cohort the one that actually is doing the.
Hum.
The net of clacks intolerant or resistant patients.
Recall that group is being treated with the.
The two drug combination.
Brexit your Burleson and decided but I also think that's the that's a lower bar.
The null hypothesis of smaller.
And that's a very attractive option, it's very similar to what we did previously with the.
The two drug combination held back and we exceeded the L back null hypothesis very nicely. We just couldn't proceed because the oncology community went away from L.
L back so I think that one the.
I believe we have over half of the patients we need for that the interim readout and the.
I would say notwithstanding any kinds of.
Patient interruptions or whatnot with the Covid hopefully the vaccine program is going to work.
Without the Advair.
And so all of that kind of thing, but that would be the first of all of the other one we're competing with the.
Like of the.
The newly diagnosed they're sort of.
There is still competition for those.
Patients as they continue the trials of the things we've been out o'clock. So I would say the two drug combination is the one that is the most.
Most likely for Torrey point.
Got it on the second question is is the phase one trial crux of the person.
Some of the tumors do you were on track to start soon.
Yes.
Recall.
There were just from new some new studies the latest.
Testing that the FCA at least of this division wanted it so.
We had to go formerly tests the entire batch of reconstituted.
Material this was the IV.
Testing the.
The stability of the drug is reconstituted in the hospital before.
Administration of the patient we've completed all of that and then we have a.
Additional test.
But we're doing bits of New award the.
We think we've just about finalized that once that's done.
We should have the I D right away and you know on.
And I'm thinking the second quarter unless there's the.
The second the <unk>.
So the testing still needs more refinement, because he not only do the testing, but you have to.
Develop the.
You know qualify the method of it and whatnot. So we think that'll be the case, we had a good call.
With the FDA on the additional things we wanted and so.
We know the.
The last steps those get completed and we should have our F D. A.
Start treating.
Got it thank you.
Youre very welcome.
Your next question is from the line of Jonathan Aschoff with Roth Capital Partners.
Thank you good morning guidance I was wondering a little more on <unk>.
Should we expect the Craig say development on.
The and ovarian endometrial and also for one out of three only in pancreatic or do you think those two phase one trials would be very much of mixed solid tumor bank yes.
Yes, I think generally Jonathan.
Dash a in one of three we'll have a similar pattern of the phase one of course is.
Dose finding and it can go across several sets of solid tumors.
And once you do that dose escalate establish of safety.
Find the dose then we would proceed let's say on dash eight.
With the.
Phase one BS.
One of the first ones would be of Paclitaxel and.
And the proxy dash eight.
Good.
The advanced ovarian and endometrial the.
Second of.
The target trial would be in.
Stage four metastatic pancreatic.
Jim side of them and.
MD Anderson.
The bio path of also worked on.
The breast cancer and I believe the.
Hormone resistant area of Triple negative.
The 100 of free again similar concept.
<unk> from.
Several.
Of the.
<unk>.
Solid tumor cancers.
<unk> again, we dose the <unk>.
Stablish safety get our dose then we would go on the two candidates.
We've done work on.
Uh huh.
Would be.
Again, the metastatic pancreatic.
And also non small cell lung cancer. So.
You know I suspect once we get into it we would do all the things I think step three is also amenable to.
Oh, hey on milk, but that's the general plan broadly across.
And the one where you dose escalate established safety and then you go into one <unk> bees in the specific areas with your specific combination treatment of drug.
Okay. Thank you Peter.
I don't know if you addressed this in the opening comments, but when do you think we can see the safety results with the practice and the double in the Triple combination and how soon once you get those safety board findings of those affirmation of the safety can you start your cohorts.
Well we.
We're gonna I I expect to be reporting out on that.
As early as the end of this first quarter.
Of the testing that's being done, but we have to have the safety of review and then we'll write it off and put it out okay. So we've completed that stuff and continue the test.
So it's really just the formal reporting part of it.
Okay.
If you assume no additional warrant option or an ATM use how long I guess $25 9 million.
On to operations.
Well, we actually we had.
The $13 million at the end of the December.
And.
We actually raised close to.
Approximately $20 million in February so through a couple of different things, including that registered correct.
Ross and so we actually have more than 25, but that will.
That will.
Probably take us well into 2022.
And the crawling through the end of it. So that's a good that's a good slug of money for us so well.
We will probably do another strategic ways.
Maybe in the third quarter.
The anticipated all of those trials, reaching through their phase ones in.
Being one of these in the following year.
Okay.
Thank you very much.
Thank you Jonathan.
The next question is from the line of Laura Engel with Stonegate capital partners.
Good morning, Hope all is well.
The <unk> question's already been asked but I wondered if maybe you could give us an update if there's been any.
Any progress or anything new to report on with some of the collaborations you have going on to just within in the Anderson or on.
I think Thomas Jefferson University at one point any anything new on that horizon on that you could share with us.
Oh, the Thomas Jefferson.
It doesn't really require our active involvement the.
We supply and develop the drug.
We actually have the electrical property on the being developed so I think they continue to work on that but it doesn't require of our.
The involvement.
I think at MD, Anderson, where really more through the clinical programs with those folks but the.
They continue to have an interest in our technology of course of doing the site from the AML.
The site for the one 002 and.
The Beaumont C O L.
The site when we get going in the net of clocks.
Relapsed AML.
And for solid tumors they were.
Kind of of the lead of.
The group that.
Did the original dash, a solid tumor work, which was done in advanced ovarian.
So in endometrial so.
You know they they continue to we continue the work along with them.
We have some other things that as we gain more notoriety.
We have other.
Collaboration is being discussed.
All of which we May have news on in the near future.
Yeah.
Yeah.
Okay, great well on.
I appreciate the update on <unk> this year have been.
And of the 19 continues to embrace the alcan.
Keep making this progress on AR and the forward with these trials, so again I'll get back into queue, but thanks for the update.
Thank you Laura.
Again to ask the question Press Star one on your Touchtone telephone.
Yeah.
Yes.
Yes.
At this time there are no further questions.
Alright. Thank you again for joining US everyone and for your continued support of bio path have a great day.
Ladies and gentlemen. This concludes today's conference. Thank you for your participation and have a wonderful day you may all disconnect.
Yeah.