Q1 2020 Earnings Call

Good morning, ladies and gentlemen, and welcome to the ball pass Holdings first quarter 2020 earnings Conference call. At this time all participants are in 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 bypass Holdings conference call and webcast to review the company's first quarter 2020 earnings 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 todays call releases are available at bio Pepco Holdings dotcom.

With me today from bio path or President and CEO, Peter Nielsen and senior Vice President Finance accounting and administration Anthony price 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 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 has discussed on todays call.

I'll now turn the call over to bypass CEO Peter Nelson.

Thanks will.

Good morning, everyone.

Thank you for joining us today.

Particularly during these challenging and unprecedented times I hope this fives all of you and your families well on sake.

Despite the extensive social impact cobot 19 pandemic.

I'm pleased to report that here at bio path, we have taken every precaution possible.

To safeguard the health and safety of our employees and clinical trial participants and that even in these difficult times.

We remain on track to achieve our clinical milestones this year.

The considerable progress we've made throughout 2019 continues to serve as a foundation for us to advance our clinical pipeline cord important inflection points in 20 twice.

As it stands now we're continuing to advance our innovative R&D I don't particle programs.

Built on our DNA, but the enable EIS platform to treat patients suffering with a variety of life threatening cancer indications.

Let me begin with a review of our DNA viral DNA otherwise platform and its key features.

As you know the de enable EIS platform is our proprietary antisense arent AI nano particle technology, which we use for the creation of nucleic acid therapeutics.

Enable ice therapeutics integrate with the cellular membrane because of their unique structure, allowing the antisense drugs to be delivered to the diseased cells with high uptake ended the sell be the incorporation into lifted layers.

There's been no evidence of toxicities associated with our technology.

We are extremely enthusiastic about the potential of our DNA otherwise platform for developing novel treatments for patients suffering from diseases with high unmet medical need.

Yeah.

Now, let's turn to our lead product candidate proxy giberson.

Where we have made substantial progress in recent months.

Brexit your person is being studied in a phase two clinical trial for the treatment of A.M.L.

As a reminder, this trial is a multi center trial that originally studied Brexit your boroughs in combination with low dose cytarabine or l. that.

And de Novo patients with previously untreated, a mel who were not otherwise eligible for standard or high intensity chemotherapy regimens or who had elected a low intensity regimen.

The trial was open label with a two states designed to assess the safety profile pharmacokinetics, pharmacodynamics and efficacy of Brexit Giberson.

The primary endpoint of that study was complete remission, including patients who achieve incomplete hematologic recovery and complete remission with incomplete platelet recovery.

Secondary endpoints assess the safety and efficacy of Brexit your person, including overall survival time to response duration of response and adverse events as evaluated by physical examination findings vital signs and clinical laboratory tests.

As you May recall last year, we presented compelling interim results from this study.

He's up updated interim results from stage one of our phase two study of productions reverse in the de Novo AML patients only increased our confidence in the safety and efficacy profile affected your person and underscored its potential to treat AML patients.

These data were particularly compelling and encouraged us to prioritize advancement of Brexit giberson in combination with standard of care.

The approval of the frontline therapy, Venetoclax provided an opportunity to add PRX two person to the combination of genetic lacks plus decided than for the treatment of Denovo AML patients.

We view PRX if your Burleson is an ideal combination candidate with frontline therapy.

Our aim is to add Brexit your gross into the leading frontline therapy is to improve treatment options for patients.

As a treatment landscape evolves, we will continue to respond to those advances.

The plans for our registration directed clinical development program for PRX Interboro Sun as a treatment for am Mel reflects these changes.

The amended phase two study evaluated the safety of Brexit Your Burleson in combination with decided than in both cohorts of patients at a dose of 60 milligram per square meter.

The study evaluated patients for a safety assessment or parts of your Burleson and decided and determine the combination to be safe and six a valuable patients.

We are in the process of modifying testing of both cohorts of patients to next add genetic lives to the breadth corrections. Your berson decided been combination treatment and test safety for the Triple combination.

Once we've completed the six patient safety assessment of the tech person to person decided been Veneta KLAX combination.

Efficacy as segment of this trial can commence.

It is anticipated that each cohort will include an interim assessment of 19, a valuable patients that would assess whether the treatment efficacy or the combination of proxies. Your berson decided been venetoclax exceeds the efficacy of current standard of care therapy with statistical significance.

Yes.

Upon such favorable data.

We intend to petition the U.S. food and drug administration the FDA.

For accelerated approval.

The efficacy segment of the trial is expected to be conducted at 10 clinical sites in the United States of which we now have nine sites committed to the phase two program.

[noise] before turning to our other programs I'd also I'd like to briefly touch on our plan to phase one clinical trial of Brexit your person dash eight in patients with advanced solid tumors, including ovarian uterine pancreatic.

At home hormone refractory breast cancer.

Procedure person dash eight a. fourth bio path drug candidate.

There's a modified product from Brexit your berson sharing the same drug substance with enhanced nanoparticle properties.

This trial is expected to be conducted at several leading cancer centers and is planned initially to evaluate the safety of presage berson sachet and solid tumor patients.

Patients diagnosed with recurrent ovarian and endometrial cancer, often have poor outcomes and it's our hope that prices you're berson dash eight may provide clinical benefit for such patients.

We filed an eye investigational new drug application Lyon D and expect to begin the study in 2020.

Turning now to plans for BP, one owed to our second therapeutic candidate, which targets Bcl two.

Last year, we filed an S I and the application for our second pipeline candidate BP one or two.

With that of class has also shown activity against the anti apoptotic protein Bcl, two and works by neutralizes the protein be age three domain.

It is an improved treatment for chronic lymphocytic leukemia leukemia, or CLL patients and untreated AML patients. However, with the exception of some patients treated treated with stem cell transplant plantation disease relapse invariably occurs often times due to be age.

Three domain mutation overtime.

BP one or two also targets the bcl two protein.

However, BP one or two activity is based on blocking the bcl two messenger are in Asia and not to be age Threed domain.

As a result, we believe that BP, one, though too could provide an alternative for genetic KLAX patients, who have relapse, including A.M.L. patients, who previously we see phonetic KLAX treatments.

In November 2019, the FDA granted us I, Andy clearance to study BP, one owed to as a potential treatment for CLL, including banana collects relapses and lymphoma.

We can amend this registration to include A.M.L. relapses, if those occur.

The plan modification of our phase two clinical program in a bell to include Panetta KLAX combination treatment with Brexit hubris and 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 or two in the summer of 2020.

Most recently this April we presented a poster at the American Association of cancer research or a CR annual meeting highlighting the plan to clinical trial design for our first in human Phase one study of DP, one or two in patients with advanced lymphoid.

<unk>.

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, and the Sarah Cannon Research Institute.

Finally.

Let me review, our progress with our third drug candidate BP, One Boe, three which targets the statthree protein.

This program has shown promising preclinical data and we're very excited for the future of this program.

We are studying BP want to O three for the treatment of pancreatic cancer.

Patient derived to tumor model.

Previous models have shown the drug to successfully penetrate pancreatic tumors and enhance the efficacy of standard frontline treatments.

The potential for our Statthree program is compelling for a number of reasons.

Signal transduction, and activator transcription three or 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 distant oregons 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 human.

Immune system surveillance and avoid construction 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 of tumor immune evasion at multiple levels.

[noise] activation of Statthree.

Has been found in many types of cancers, including non small cell lung cancer.

Am Mel and pancreatic cancer.

Activation of Statthree correlates with poor clinical outcome.

Hi, great disease, and metastasis and has been linked with resistance to chemotherapy, including Jim side have been considered a standard of care agent for advanced pancreatic cancer.

Therefore inhibition of Statthree in combination with chemotherapy is expected to produce enhanced clinical benefit.

Our pipeline our preclinical data for this program highlighted for Andy sense over those sequences directed against Statthree.

Messenger are in a identified by buyout path and manufactured using DNA mobilize antisense R&D nano particle technology.

Cell viability tests and western blots were conducted to determine the inhibitory effects of liposome incorporated Statthree antisense oligo on non small cell lung cancer and hang on that'll cells.

An ex vivo life tissue sensitivity asset.

This performance with a panel of 20 pancreatic patient derived xenograft.

To study the overall activity of BP 103 alone and in combination with just jumped side of it.

Using previously defined criteria tissue flies viability inhibition greater than 30% with a P value of less than <unk> 0.05 counted as a response.

For Dallas for validation of ex vivo results pancreatic cancer.

Cancer patient derived xenograft, so tumor bearing mice were administered BP, one Boe three and Jim side of it twice a week for 28 days.

Tumor volumes were monitored for up to 49 days.

In the live tissue assay.

BP 103 at a dose of 10 microcontrollers significantly inhibited the tissue slice viability nine out of 18.

Pancreatic cancer patient derived xenograft by more than 30% with a P value less some 0.05.

The combination of BP, one or three and Jim cited in further enhanced ex vivo efficacy of BP One O three in a subset of patient derived xenograft.

In the Nvvault study with pancreatic cancer patient derived xenograft models, a combination of BP, one O three and jump side of it caused tumor regression during the 28 day drug treatment period.

This anti cancer activity was maintained for another 21 days, even one drug treatment had ceased.

In addition, BP want to O. Three was selected as the most potent liposome incorporated statthree antisense sequence and decreasing non small cell lung cancer cell viability.

Further validation in AML cells demonstrated.

The BP one O three inhibited cell viability and statthree protein expression.

He is very encouraging data that data were well received by the scientific community.

We're particularly excited to launch our first in human validation of this cutting edge therapy.

Special.

Especially.

Challenging cancer indication that has limited treatment options.

Moving forward, we are and undertaking and I Andy.

Enabling studies for BP, one or three this year with a goal to file and I and the application with this very promising product candidate later in the year.

As you can see despite kovacs 19 global pandemic.

We have remained committed to driving forward or clinical development programs. During this challenging time.

We continue to advance our important programs and remain committed to evaluating new opportunities to capitalize on the potential of our DNA belies technology platform in various oncology indications.

With that I'll now turn the program over the Anthony price price for it.

Brief review of our first quarter 2020 financials, along with balance sheet highlights Anthony.

Thanks Peter.

The company refer to the net loss of 3.3 million or 90 cents per share for the three months ended March 30, Onest 2020, compared to a net loss of 1.5 million or 89 cents per share for the three months ended March 30, Onest 2019.

Research and development expenses for the three months ended March 30, Onest 2020 increased to 2.0 million compared to point 4 million for the three months ended March 30, Onest 2019, primarily due to the manufacturer of drug material in preparation for our phase one clinical trial procedure person.

A and advanced solid tumors, an increase in clinical trial expenses related to increased enrollment.

Our phase two clinical trial FC Giberson in AML.

And startup activities for phase one clinical trial of BP 100 true in lymphoma, as well as increased preclinical study expenses.

[noise] general and administrative expenses for the three months ended March 30, Onest 2020 increased to 1.3 million compared to 1.1 million for the three months ended March 30, Onest 2019, primarily due to increased franchise tax expense.

As of March 30, Onest 2020, the company had cash of 17.9 million compared to 20.4 million at December 30, Onest 2019.

Net cash used in operating activities for three months ended March 30, Onest 2020 was 2.5 million compared to 2.0 million for the comparable period in 2019.

With that I'll now turn the call back over to Peter.

Thanks Anthony.

As I've described on this call we are enthusiastically looking forward to advancing each of our preclinical development programs through to value, creating inflection points during this year.

Each of these programs has strong clinical data underlying the potential and each of them addresses an unmet medical need.

Before opening up to your questions I would like I would be remiss, if I didnt acknowledge and a plug those on the frontline fighting the global Cobot 19, and then Nick.

In particular goes nurses and put as physicians, providing direct care for cobot 19 patients.

And as always we greatly appreciate your support as we advance the therapeutic candidates built on our DNA belies platform through clinical trials in preclinical research in a number of important oncology indications that we believe will benefit cancer patients worldwide.

With that operator, we're ready to open the call for questions.

Thank you to ask a question you would need to press star one on your telephone.

To withdraw your question press the pound key again, if he would like to ask a question press star one on your telephone.

And our first question comes from Yi Chen with H.C. Wainwright. Your line is open.

Thank you for taking my question.

My first question is.

Could you provide some color.

Status of the clinical sites for the Triple combination regimen and when do you expect.

The issue when do you expect the initiation of the.

[noise] Brexit your question a triple combo to start is it likely to occur in December and if the afterward, if it does occur.

Do you think the in Rome, and speed could be adversely affected by going Koby 19 situation. Thank you.

Okay. A couple things there evidence we have I'm not sure when we can release it but we have.

Preclinical studies I think we've talked to this a couple of times ago, you and they do affect to indicate a very positive incremental benefit of adding Brexit you burleson to the Moneta Clecs combination. These are in cell line.

So lines in AML cancer cells and in the measurement is on.

You know reducing cell cancer cell viability.

Sure when that comes out but it will have actually put it out as you know it's always.

What's the mechanism that we can do that.

Secondly.

The.

In terms of timing, we're actually on the clock now we've had several.

Nuisance changes that the FDA they wanted us to do but you know the.

So those guys call. The shots. So every time to do that you got to go back and roll through the changes through protocol and investigative brochure etcetera, and then resubmit and you go back on the clock we are we're.

At four.

We'll be within it today.

Early next week on the clock for 30 days and this last change was very minor.

Two would change so I think that we may not even half to two.

[music].

Wait a full 30, so certainly in June we should be.

We should be cleared.

To start.

And of course, we continue to.

To work on.

Hello Amendment 15.1, which is the safety of Brexit your gross in the decided.

And we have patients that are continuing on that to.

Durability.

We have two patients at MD Anderson.

Ones on the seventh cohort and others on the eight cohort and.

Yeah, that's pretty impressive response and durability.

So that's a.

I think that I did I answer all you had three or four components to your question you did I get them all.

Oh.

The last component was once the trial starts to you seem to be in Rome and.

Oh, yes really affected.

Well you know we can't.

You know it's hard to tell you know that the people that go to the hospital for treatment.

[laughter].

That's where we may have some slowdown because remember.

The co that can be devastating and.

[noise] immune compromised.

Patients so oh.

I know we've seen one in New York.

Seem to be on study going well.

We still had three patients down here lumpy Anderson, but it's.

It's hard to predict until we get into it.

So I think we have to anticipate there might be some slowdown in that.

As you know, we're adding we're adding more sites.

And we were at six.

I have three more there I think one's been added already Georgia cancer Center, which two to three more that are in the process.

Okay.

Doing their paperwork and trying to get things finalized so it seems that particularly with.

People working at home and whatnot, the administrative processes can be slower the institutions, but.

We anticipate we could see some slow.

But we we certainly haven't been formally formed.

Okay. Thanks.

So during the rest.

During the rest of 2020 and considering the impact of Koby 19, what are the potential.

In a read outs.

Do you expect to have across a procedure for us and if you want to BP one though.

Sorry, if you want to model to be more.

Well and Inpex comparison in the A.M.L. trial, we would start and.

First real announcing point would be 19 units in each cohort and we can we will do that announcement when we reach it we don't have to have all cohorts hit 19, and then we have announced so.

Whether that happens.

Quickly enough than this year, it's just hard to say, we will keep adding.

Patients the.

The combination treatment as again said and the.

Preclinical work indicated.

Pretty impressive response, so we'll just have to see.

About that the.

BP Oneto too.

That's a three plus three dose escalating so.

We'll have outcomes.

We can report on.

Certainly one maybe two and the.

From from that again, thats in CLL and and.

Lymphoma.

And.

In solid tumors.

So again, we're just on that one.

Waiting on.

Completion of the validation.

Work on one particular asset we've got couple others to do we know how to do all but one of them has got some validation that it takes time to just do those things could get the testing from the has completed so but we should that for sure open that and.

Have ideally that's a three plus three so ideally have.

One of those.

[noise] cohorts at least a completed.

The other thing then that would be good is.

If the if we can hit our goal on the the hi, Andy for Statthree.

If you want to O three so again that depends on completion of the.

Of course preclinical programs, one of which is kind of new since so one of the potential benefits of BP Whoa three.

Is.

You know its effect on the immune system.

And this surveillance.

Because of that of course, we anticipate and we'll probably have a pre FDA call on this.

We anticipate that they're going to want to see.

The safety of that treatment and its potential effect and this would be a in vivo study.

On the immune system. So we have quite a lot of things that can go on this year.

Okay, and lastly up before the patient recruitment stars do you expect operating expenses to remain at a lower level.

Yeah I think.

You know as we've talked about on calls previously our our expenses fluctuate.

Based on.

A lot of with based on drug build up and so we had a lot of that activity in the second quarter or in the first quarter.

And.

We have just about you know.

We'll continue to have some of that but.

No we built some batches for.

You know like BP, one owed to as a new one we've added some more flexi giberson just to make sure we have enough not going.

How fast the enrollment logo so I.

I think right now.

With this patient level, two to 3 million a quarter.

It's quite a number if if we go by the budget plan that we had will eventually all three trials going we've probably got between three and 4 million.

Our financial model predicts that by the end of the first quarter next year, we'll still have.

[noise] more than the quarter's worth.

Funds left so we were.

You've probably seen the balance sheet, we've got a pretty decent balance sheet, almost 80 million in cash.

As a 331.

And.

We have opportunities to raise I'd, just like to be a little further along in milestones for raise it.

Got it that's all for me thank you.

You're welcome.

Thank you and I'm showing no further questions at this time I'd like to turn the call back to Peter for closing remarks.

Thank you again for joining us on for your continued support of bio path have a great day.

Ladies and gentlemen. This concludes today's conference call. Thank you for participating you may now disconnect everyone have a great day.

[music].