Q2 2019 Earnings Call

Good morning, ladies and gentlemen, welcome to the bio path holding second quarter of 2019 earnings Conference call.

At this time, all participants are not listen only mode. Following the formal remarks, we will open the color for your questions.

I mean, I like to turn the call over to Willow counter I've started Investor Relations. Please proceed.

Thank you operator looking to the bio Penn Holdings conference, calling what cats term either company second quarter 2019 earnings results and to provide an update on recent pipelining corporate development.

Earlier, we issued a press release, which outlines the topics that we plan to discuss on today's call. The release is available at bypass holdings Dot com.

With me today from bypass, our president and C.E.O., Peter Nelson, and Vice President of Finance and accounting Anthony price.

Before we begin the call I'd like to remind you of today's discussion will contain forward looking statements involve risks and uncertainties. These risks and uncertainties are outlined in today's press release and in the company's recent filing for the Securities Exchange 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 the E.S. Peter Nelson.

Thanks, well.

Good morning, everyone and thank you for joining us today.

Throughout the second quarter, which continued to build our d. enable lies flat for.

And to execute or clinical development plans for our innovative or are they.

Metal particle therapeutic.

As I'll describe in more detail later in the call.

We have initiated amended cohorts of our phase two study <unk>.

There will be two cohorts of patients the first in untreated acute myeloid leukemia, or A.M.L. and high risk my little bit scholastic syndrome, or M.D.S. patients and the second cohort in <unk> relapse, A.M.L. and high risk M.D.S. patients.

Safety will be evaluated with <unk> decided that a class.

The final step will be to evaluate the efficacy of the triple combination <unk> decide events and Veneta KLAX in both cohorts of patients.

I'll begin by discussion with a review of our platform technology.

As you know.

The D. unable eyes platform is our proprietary handy sense or are they nano particles technology.

Which we use for the creation of new clay acid therapeutic.

D enables therapeutics integrate with a cellular membrane because of their unique structured.

Allowing the anti sense drugs to be delivered to the disease cells with high uptake into the cells the incorporation into the Olympics layers.

There has been no evidence of toxicity associated with our technology.

We're extremely enthusiastic about the potential of R.D. enable wise platform for developing novel treatments for patients suffering from the disease with hi, Annette.

Medical needs.

Excused.

Let's review the progress we've made advancing our lead products he doesn't <unk>.

Cretsinger person is being studied database do clinical trial for the treatment of A.M.L.

As a reminder, this trial is a multi center studies that originally studied <unk> combination with low dose like terror.

For L. back into no patience with previously untreated A.M.L.

Who are not otherwise eligible for standard.

Or high intensity chemotherapy regimens or who have elected a low intensity regiment.

The trial was open label.

With a two stage designed to assess the safety profile pharmacokinetics pharmacodynamics advocacy oppressive your person.

The primary endpoint of the study is complete remission.

Including patients who achieve incomplete hematology recovery.

<unk>.

And complete rubbish and with incomplete.

Platelet recovery.

Secondary endpoints will assess the safety and efficacy of <unk> included overall survival.

Time to response duration of response and adverse events as evaluated by a physical examination findings vital signs and clinical laboratory tests.

In April 2018, we presented exciting interim results from our phase two study.

During the first quarter 2019, we were pleased to record additional analysis from this study.

In our in our original interim analysis from this ongoing phase two study.

Our results showed 47% of the valuable patients showed some form of response to the combination treatments, including for patients with complete remission or 24% for patients with stable disease, including one patient who would achieve the leukemia free status and one patient who had significantly reduced bone marrow.

As you may recall during the first quarter of 2019, we announce updated infirm results from this study.

The updated interim results showed that the advocacy profile had improved to where 11 or 65% of the 17 invaluable patients had a response, including five 429%.

Who achieved C.R., including the C.R.I. and one more pure logic leukemia free state in six stable disease responses, including two patients who had greater than 50 per cent reduction in bone marrow blacks.

Importantly, true investigation by the principal investigators it was observed that 68% of these patients were secondary a. about all patients and extremely difficult class to treat.

These updated interim data from stage one of our phase two study <unk> ended over A.M.L. patients only increase our confidence in the safety and efficacy profile a proxy your person and underscore its potential to treat A.M.L. patients.

A complete response rate for L. back treatment alone.

For the class of patients in this study.

It was benchmark at 7% to 13%.

Whereas proxy to burst of treatment with L. back showed a 29%.

See our rate with a highly favorable safety profile.

The recent approval of the front line therapy Banana KLAX provides an opportunity for combining <unk> with the combination of banana KLAX plus the seidelman for the treatment of the noble A.M.L. patients.

As we upset support we view parks with your <unk> as an ideal combination candidates with frontline therapy.

Our aim is to match or exceed your burst in with the leading front line therapies to improve treatment options for patients.

As a treatment landscape evolves, we will continue to respond to those advances the planes were our registration directed clinical development program for <unk> as a treatment for A.M.L. reflects these changes.

Personally.

We have amended the existing stage to clinical trial.

The key change in the amended phase two study is the inclusion of patients with high risk My love is plastic syndrome, or M.D.S.N. refractory relapsed A.M.L. patients.

The restructured phase two clinical trials now has two cohorts of patients the first being treated A.M.L. patients as existed in the pre amended trial, but with the addition of high risk M.D.S. patients.

And his second cohort comprised of we crack pre relapse A.M.L. patients and high risk A.M.M.D.S. patients.

Yeah amended phase two studies will continue evaluating the same safety approx diversity in combination with decided that it both cohorts of patients at a dose of 60 milligram per square meter in combination with the side of it.

The study will include a total of six you valuable patience for each study assessment of <unk> and decided.

Today. The company is enrolled five patients of which three are a valuable three untreated A.M.L.P. sure patients.

Who received therapy prior to amending the trial.

And to patients who are now being treated under the bed the phase two trial.

Assuming I successful completion of this study's assessment. The study will then modified testing both cohorts of patients.

You had phonetic class to the <unk> decide of in combination treat.

<unk>.

Patient study assessment of the proxy traverse and decided that the medical X. combination yeah advocacy segment of this trial will commence it is anticipated each cohort will include it in <unk> at 19 invaluable patients.

That would assess whether the treatment advocacy or the combination affected your burleson decided that kinetic wax exceeds the advocacy of the current standard of care therapy with statistical significance.

Upon such favorable data.

File path wouldn't petition the U.S. food drug administration for the F.D.A.

For accelerated approval.

Yeah, because he's segment of the trial is expected to be conducted at up to 10 clinical sites in the United States.

Moving forward the company intends to evaluate potential political sites in Europe .

With an emphasis on patient pools.

[noise] overall.

These transformational steps will result in two registration directed cohorts.

Of our phase two clinical trial.

It Ain't belt.

Both cohorts will study proxy two person plus the side of it and plus but that a class.

One four untreated A.M.L.M.B.S.

The other four relapse group Directory A.M.L.M.D.S.

[noise] before turning to our original additional programs.

I'd like to briefly touch on our plan phase one clinical trial <unk> inpatient.

<unk> advanced solid tumors, including the very into.

Uterine pancreatic.

In potentially hormonal, we practically breast cancer.

This trial is expected to be conducted several leading cancer centers. It is planned initially to evaluate the safety <unk> in combination with standard of care for each tumor type.

We expect to file an I.D. by the end of the third quarter into initiate this trial and 2020.

Next let's review the political pre clinical data recently presented.

From our third drug candidate B.P., one o., three which targets at the stat three protein.

We are studying B.P., one o. three for the treatment of pancreatic in a patient drive to model.

Previous models have shown the drug to successfully penetrate pancreatic tumors and enhance the advocacy of standard front line treatments.

The results from our pre clinical studies of B.P.. One O. three were highlighted in a poster presentation at the American Association with cancer Research annual meeting.

Or the A.C.R.

It is Lana in April .

We we are excited it'd be targeting step three for a number of reasons.

Signal transduction inactivated transcription three or staff three.

So typically inactive in normal cells is apparantly active in cancer cells.

The ability of tumor cells to proliferate uncontrollably.

We just pop up kocis or cell death.

Induced vascular formation.

And in base distant organs are well recognized hallmarks of cancer.

<unk> three is a regulator of the genes involved at least cancer process.

More recently the capability of tumors to evade immune surveillance.

Abort destruction by the immune system has also gained significance.

Significant exceptions in the cancer research field.

A free which is a point of convergence.

<unk> oncologic.

Pathways has emerged as a critical mediator puberty immune evasion at multiple levels.

Activation upstairs three.

It's been found in many types of cancers, including non small cell lung cancer.

A.M.L. and pancreatic cancer.

Activation of staff three correlates with poor clinical outcome I agree disease in the past assist and has been living with resistance to chemotherapy, including Jim Seidelman.

Considered.

Standard of care for advanced pancreatic cancer.

Therefore, it had been troops that three.

Combination with chemotherapy.

It is expected to produce enhanced clinical benefit.

The poster at A.A.C.R. highlighted for 80 cents over those sequences directed against that three messenger are a day.

Identified by bio path.

Been manufactured using de stabilize antisense already I dunno particle technology.

[noise] cell viability test at Western blot were conducted to determine the inhibitory effects of liposome incorporated stat, three antisense old ago, well, it's non small cell lung cancer in E.M.L. cells.

And <unk> tissue sensitivity essay.

What is performed with a panel of 20 pancreatic patient derive xenografts.

To study the overall activity of D.B. what else.

Three Oh whoa.

And in combination with Jim side of it.

Using previously defined criteria.

Tissue slice variability inhibition greater than 30%.

With the p. value less than 0.5.

It was a response.

For validation of X. Tivo results pancreatic cancer patient derive xenografts of tumor bearing mice were administered beeping 123.

And Jim side of it twice a week for 28 days tumor volumes were monitored.

Pull up to 49 days.

He's alive tissue S.A.D.C., one o. three at a dose of 10, Michael Moore.

Significantly inhibited the tissue slice variability viability.

Nine out of 18 pancreatic patient derives intergraph's by more than 30% for the P. bag lesson point, though.

The combination of beating one of those pre and Jim side of further enhanced actually will advocacy agreed in one of those three in a subset of patients garage xenografts.

In the.

<unk> pancreatic cancer patient drive xenograft bottles, the combination of beat P., one o., three and Jim Suydam in college tumor regression.

A 28 day treatment period.

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

He's very encouraging data were well received it.

You are where we had a very positive response.

We are particularly excited to lunch with this program has it will be our first and humid validation of this cutting edge therapy is especially challenging cancer indication that his limited treatment options.

In addition be wonderful three was selected as the most potent liposome incorporated stat 380 cents sequence in decreasing non small cell lung cancer cells viability.

Further validation in A.M.L. cells demonstrated that between 103 inhibited cell viability in step three protein expression.

We're excited by these pre political data.

And it'd be tackling solid tumors without proprietary technology platform.

We look forward to continuing R.I.M.D., enabling studies.

<unk> three in 2019.

With a goal to interact personally human trial with this very promising product candidate next year.

Finally, we have also updated our plans for V.P. 102, or second therapeutic candidate, which targets B.C.L. two.

But then the classes also showed activity against the ending up totally protein D.C.L. too.

And it works quite neutralizes the protein speech three double date.

It is an approved treatment for chronic we're proceeding leukemia or C.L.L. patients and untreated A.M.L. patients in combination with the side of it however.

With the exception of some patients.

<unk> with cell transplantation.

Disease relapse invariably curse oftentimes due to be H.C. domain mutation overtime.

V.P. one o. two also targets the B.C.L. two protein however.

P. P. one o. two activity is based on blocking the B.C.L., two messenger, Orange, Hey, and not the B.H.C. domain.

As a result, we believe that the P. one o. two could provide an alternative that KLAX patients whoever relapse.

Further we believe there will be A.M.L. patient relapses from banana plaques treatments, representing an additional opportunity for bio path to treat those patients with G.P.S. 102.

As a result, we believe we'd be able to file for registration of D.B., one or two for the treatment of banana KLAX relapses in both C.L.L. patients a day M.L. patients.

The plan modification of our phase two clinical program than anything else to include bit at a class combination treatments with <unk>.

Will give us early sequence experience.

<unk> B.C.L., two driven <unk> ptosis hidden stations.

And as always we continue to evaluate opportunities to expand or being unable wise technology platform in other college and indications.

Finally, I'd like to briefly highlight that we successfully raised $21 million in the first quarter along with two small awkward.

This is financing enables us to execute on our clinical development plans for three promising therapeutic candidates.

With these additional funds, we don't have the resources to achieve the number key milestones that we believe should significantly enhance shareholder value.

With that I'll now turn the program over to Anthony price for a brief preview.

Of our second quarter financials, along with balance sheet highlights.

Anthony.

[noise] Thanks Peter.

The company reported a net loss of 2.5 million or 87 cents per share for the three months ended June 30th 2019, compared to a net loss of 1.7 million or 296 per share for the three months ended June 30th 2018.

Research and development expenses for the three months ended June 30th 2019.

Increased to 1.5 million compared to point 8 million for the three months ended June 30th 2018, primarily due to the commencement of activities related to stage two of our phase two clinical trial in M.L. to include Banana class combination treatment, the prestige embarrassing and two cohorts of patients.

General and administrative expenses for the three months ended June 30th 2019 increase to 1.0 million.

Compared to point 9 million for the three months ended June 30th 2018.

Primarily due to increased legal fees and insurance costs.

[noise] as of June 30th 2019, the company had cache of 17.1 million compared to 1.0 million.

At December 31st 2018.

Net cash used an operating activities for the six months ended June 30th 2019 was 4.2 million compared to 3.4 million for the comparable period in 2018.

[noise] net cash provided by financing activities for the six months ended June 30th 2019 was 20.3 million.

What that I'll know turn the call back over to Peter.

[noise] examining.

[noise] enclose it throughout the first half of 2019, we've made meaningful progress advancing or political development pipeline.

We are dosing patience is a new cohorts of the phase two study <unk>.

And we are moving are pretty political candidates towards first in human clinical trials.

These are very exciting times at bio path.

And we are enthusiastic about the opportunities ahead throughout the balance of 2000 2019 it'd be on.

We have a number of milestones.

I had that we believe will evaluate creating a collection points and we look forward to achieving things goals.

In the coming months and years.

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

Thank you, ladies and gentlemen, if you'd like to ask a question. Please head star than the number one key on your touch tone telephone.

If your question has been answered or you wish to remove yourself from the queue. You may do so by pressing the pound key.

We ask that you. Please eating lying once you've mastered question to prevent any background noise from coming through.

Again that is star than one if you'd like to queue up to ask a question.

Our first question comes from Laura angle bust don't get capital markets.

Now open.

Good morning, gentlemen, thanks for all that detail information.

I like appreciate that just really just two points of clarification.

Peter on B.P. want their your team.

Could you update or just clarify on that try I mean on the program Lantana N.C.L.L. program filing an I.M.D. application for that what's the timing looking like on that and then.

Just clarify on B.P. <unk> three could you be more specific as far as.

Maybe first half second half 2024.

Maybe not program on just a little bit more about the timing on as everything else.

<unk>.

I appreciate it so.

Okay.

The B.B. one O.O. two.

Yeah that actually in in my comments I dedicated we had that I'd be filed the third quarter and we're pretty close unless there's some additional information requests it comes up but frankly.

That I am d. or the files were prepared and it's in the process of.

[noise] electronic.

Transformation into files, but.

And.

Be filed electronically in the I.D. I think that you know you have to do that now so it's in that process right now.

I believe we have all of the additional C.M.C. information that.

We deal with our experts we work with.

We'll need a these are additional times now that they want to drug substance it'd be incorporated to lift so so that's.

Additional little more complicated things, where we had the whole work that so one process actually doing that.

Now for V.P. 103, my <unk> memories, we have about a five.

I.D.A.

<unk> studies to do one of which we've added an x. two because.

Step three years so.

Really quite interesting though.

Protein you know it's affecting the immune system, we have to had to come up with another you know working with.

Oh, so we're experts P.I.s.

For testing did in fact, we were having a negative effect.

Oh the immune system.

So and so were you know had that study or the latest update I had we wouldn't.

Have all those studies under way by the.

End of the year.

It may be just a month or so overlap on the city shows of one which I think is that.

Sensitivity tests.

And then from there. It's you know it's simply compounding no.

That'll be an all new I.N.D., so it'll be one of those large documents so.

I'd like to have that eye it'd be filed.

By the end of the first half of 2020, maybe fascinating yeah, but we have the template.

<unk> B.P., one oh too so we don't have been better than saying do so it's typically with these things now that some of these complicated indications it's the protocol.

And we have a lot of reviews as you know we have a lot of K.O.L.'s.

And.

They bring new insights yeah, we had one with a solid tumor that came with F.D.A. meetings gave us some some additional direction.

That.

We felt we needed to take.

Aadvantage joke in <unk> help.

So that's that's the thing so we should be testing it in humans.

<unk> the second half of 2020.

Oh, Okay, well, great and my project for T.U.N.

You know something like keep an eye catching escape contracts expected dollar moving along and I just wanted to say good morning, and get this clarification. So I appreciate that and I'll get back in the cave.

Well. Thank you we appreciate your sport.

Thank you weren't next question comes from you chat with H.C. Wainwright airline.

[noise] [noise]. Thank you for taking my question.

My first question is has the company completed at the pre clinical study after triple combination.

Yes, when you have and and it showed I.

That's a good <unk> well I guess I got at least coming but yes, we headset, we've done that and we've showed a significant benefit of combining the two in terms of.

Reducing.

I'll sell viability. So yes, we have that and so we have that ground work to go forward.

With the test and get your butts.

Do you plan to release to briefly makes it a little bit so it's anytime soon.

[noise].

Oh, we'll certainly indicate.

You know that you know the benefit we saw.

We probably I I think we did both the last time when we did this with.

<unk> and some of the others so.

I think we will but I I can't say that I've had that discussion, but we typically want to put the information out there.

Okay.

During the remainder of 2019 do you expect any data where you know such as speedy.

From the cohort <unk>.

Well I think what we would normally do is.

Is.

We'll give a readout from the safety in decide had been in <unk>.

That's six a valuable patients as I indicated in my comments, we have five now and a tree a valuable.

Two in process, so I'm pretty confident.

We'll we'll have that six one and when we do that.

You know again, we follow that.

The template.

What we did when we did our.

<unk> safety in combination with the old Akron proxy the boroughs and we.

We gave up.

Readout on the safety and of course, if we had any yet.

Education so.

You know the advocacy we also put that out so.

If we follow that.

Template.

Which I'm sure we will.

I would expect we'd have.

Some kind of readout information in the fourth quarter earlier than later.

God Oh. My question is do you expect the operating expenses answered and fourth quarter to be comparable to those in the second quarter.

Well as you know you know these things are moving averages and we typically been.

About.

Million 5 million six.

Burn rate, but cash and I think in the fourth quarter, we're probably getting ready now <unk>.

To move up to I think.

Maybe a a two legged late.

Okay.

Alright, thank you.

Alright. Thank you you appreciate your sport.

Thank you and I'm showing up for the questions in the queue. At this time I like to turn to call back to Peter Nielsen for any closing remarks.

Thank you operator.

Thank you again, everyone for joining us and for your continued interest in support of bio Pat.

Have a great day.

Ladies and gentlemen, thank you for your participation on today's conference. Just doesn't include your program in your mail disconnect everyone have a great day.

Yeah.