Q4 2019 Earnings Call

Ladies and gentlemen, today's conference is scheduled to begin shortly please continue just standby. Thank you for your patience.

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Good afternoon, and welcome to all can never therapeutics corporate update and full year 2019 financial results Conference call. At this time, all participants are in listen only mode.

Speakers prepared remarks, there will be a question and answer session to ask a question. During the session. You May Press Star then one on your Touchtone telephone.

As a reminder, this call may be recorded at this time I would like to turn the call over to abbey older Senior Vice President of corporate development in General Counsel.

Thank you operator, good afternoon, and welcome to OCC Inovas fourth quarter and full year 2019, corporate update and I know its financial results conference call earlier. This afternoon, we issued a press release.

Our financial results in business progress during the year. If you have not seen this press release is available on the Investor Relations page of our website at Www Dot Onconova dotcom on today's call Dr., Steve Kaufman, President and CEO will discuss the Companys recent highlights and anticipated.

Clinical business milestones.

After Steve completes his opening remarks, marking our CFO.

View, our 2019 financial results. Following Mike's report, we will look to the Q1, a portion of the call, which will be joined by Dr., Rick Woodman, Our Chief Medical Officer.

Lastly, the we'll come back with some final brief comments and a review of upcoming milestones before we begin I remind everyone that statements made today. During this conference call will include forward looking statements under the Safe Harbor provisions of the private Securities Litigation Reform Act of 1995.

Got you bought risks and uncertainties that can cause actual results could differ materially.

Forward looking statements speak only as a good they are made actually underlying facts and circumstances may change, except as required by law Onconova disclaims any obligation to update these forward looking statements to reflect future information events or circumstances.

Please see the forward looking statements disclaimer in the press release issued this afternoon.

And the risk factors and the company's current and future filings with the FCC.

With that I'll turn the call over to Steve.

Thank you Bobby.

Good afternoon, everyone and thank you for joining todays call.

I would like to apologize for the delays and initiating the quality with some technical faxes.

From the operating system that really was out of our control.

We also hope all of you were stage.

Practicing guidelines for hours C D C.

As you know.

As a very serious Derrick.

Obviously, please take good care.

29, King and early this year Rep rejected pureed up significant dance.

Okay no.

Hi, largely by our recently completed enrollment.

The middle Phase three trial in higher risk mile just plastics and girls.

Well, what evidenced by enrollment now complete.

We await the reporting of 288 survival events.

Before releasing topline survival data.

As disclosed earlier this afternoon.

We expect topline survival data.

I'll be available during the second half 2020.

Sure Mark.

In spite trial.

Correct.

The slower rate it should change it's above historical published data.

The reporting a bid Daisy.

It is expected in the second half of this year.

Yes, she was our best estimate at this time.

However.

The impact of de evolving situation was Colbert nine gene.

No.

As you recall inspire trial isn't open label randomized controlled international studies.

Designed to determine the extra capacity.

The total ability.

Single agents intravenous would be groceries in.

In the treatment of patients, which second line I risk Mds.

Patients. This study I left it's easy to use an age I'd have to go that's time relaxed failed to respond to previous tree.

Natural eating aging therapy.

The study randomized patients to receive either legal or sort of the best supportive care.

For the physician's choice there.

Supportive care.

The primary endpoint Oh, sorry, its overall survival.

Randomized patients in the intent to treat population.

There's a second opportunity.

And you have to your true.

Acutely sequence your analysis of the overall survival.

Very high risk.

As defined by the revised international prognostic, scoring system.

Should we go short or long survival is means bharti trial, and they statistically significant gets mad.

We believe renegotiate or it could be first new treatments.

Hi, rich Mds in more than 15 years.

In addition to these five trial.

We are preparing right pivotal phase two slash threed combination trials.

Oh sure it up and they decided.

For the treatment of adult patients age with H. remains I eat high risk Mds.

We received feedback when do you have even 29 G.

I'd also carry these days to slash Threed protocol.

We anticipate this study will begin later this year.

In conjunction with the data readout from these fire study.

At the American Society of Hematology annual meeting in December 29.

If you know presented a number abstracts.

I would develop programs for both intravenous and oral regrow searches.

Did you know my data from the inspired trial identified.

Most common mutations in high risk Mds.

Just I cited the exact.

Quoting knows rats huh.

That are targeted by Google searches.

We believe the phase two day.

Before we go shirt in combination with age decided the forms the foundation.

Future adaptive trial and eat your name Nike Hi.

Yes patients.

We appreciate recognition right ash expert reviews designate this day to be as such.

But it was given an oral presentation at.

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That's presented at Ash.

He said two combination oral rigosertib and they decided they showed an overall response rate of 90% nine up.

And they complete response rate of 34%.

Complete response or C.R.

By definition.

Signifies the patient as a normal appearing bone marrow.

And the bone marrow reduces enormously peripheral blood.

Gosh these patients who are typically transfusion dependent.

Randy transfusion independence.

Which could you walk through great clinical benefit.

The median duration of response is 12.2 months.

The company believes these data supports the design of a planned phase two.

Last three adaptive trial and it your mate naive high risk Mds patients.

We've also made important progress with additional pipeline programs as well.

You are legally their kids focus.

Yes.

Please about other pipeline progress.

In particular, the probably about plans to study we go through the rest driven cancers, including a study in K ration chain lung adenocarcinoma.

We anticipate the first patients to be engine onto the trial once the cold bid 19.

Sorry, I meant.

Sufficiently.

Well checkpoint inhibitors represents a significant advancement.

The standard of care.

Treating lung cancer.

Men this unmet medical need remain.

And our view, making our novel combination approach, which now Todd.

Oh, great interest to pursue.

Oh and once you reach 300.

He was our investigational.

First in class dual inhibitor.

He gave for six and arc five.

Which we believe.

The potential to treat numerous cancers, including refractory metastatic breast cancer were CDK foursixty inhibitors have held.

Already approval.

As a reminder.

Entered into a license agreement.

Our next Biopharmaceuticals Oh in one two or three 300 in December of 27 team under which had that will provide full funding required.

For Chinese I envy, enabling studies performed.

Trying these health authority I N D approval.

Right and how that's also intends to these studies to comply with FCTA standards.

Hi, Andy was approved in January 2020, why did your R&D tells the story.

The manufacturer or in 123 to be Andres has been identified already and qualified.

We plan to fly a U.S. R&D Q Oh in 123 300 into fourth quarter of 2020 after they can be quite manufacturing data for vast filing.

So those who are not familiar with the field CDK inhibitors have emerged as promising compounds targeting very large indication.

Well known receptor positive metastatic breast cancer.

The current generation of commercially approved skewed educated inhibitors as limitation.

Due to its unique targeting the block side as well as she DKK four and six.

We believe Oh in one two or three 300.

Potential.

Overcome many of these limitations, making our drug candidate potentially suitable.

Certain cancers that may not be responsive to the current generation CDK for six inhibitors.

If successful.

We believe Oh in 123 300.

I would address this very large market opportunity.

They potentially better.

Yes.

We maintain global rights.

Or in 123 300 outside of China.

The fourth quarter of 29, TD and early 2021.

We've adopted on the business development rights as well.

We executed a license agreement.

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We executed a license agreement for me go screwed up.

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We we acquired the rights to read goes shrewd in greater China.

Cognex Biopharmaceuticals.

And we entered into a pre approval axis collaboration.

With sexual medicine.

For me go solution select countries outside of United States.

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I couldn't over retains the right.

States.

Europe, and China for rigorous Oh, we look forward.

Further businesses business.

No.

Opportunities.

And now.

I could turn to pull over to mark or in our Chief Financial Officer. So.

Right discussion about financial results fourth quarter on quarter 29 key.

Mark please.

Thanks, Steve and good afternoon, everyone.

Cash and cash equivalents as of December 31st 2019 totaled $22.7 million compared to $17 million as of December 31st 2018.

Besides the $9 million of net proceeds from the financing we closed in early 2020.

On the stock warrant exercises since December 31st 2019 have added $5.7 million to the company's cash balance, resulting in a cash balance at February 29, 2020 of approximately 32.6 million.

Based on our current projections, we expect that our cash and cash equivalents will be sufficient to fund ongoing trials operations into the third quarter of 2021.

Our net loss was $21.5 million for the year ended December 31st 2019, compared to $20.4 million for the comparable period in 2018.

Research and development expenses were 15.5 million for the year ended December 31st 2019, and 16.9 million for the comparable period in 2018.

General and administrative expenses were 8.3 million for the year ended December 31st 2019, and 7.6 million for the comparable period end 2018.

We continue to manage our resources carefully while maintaining our primary focus on completing the aspire trial.

This completes my financial review I'll now turn the call back seat.

Thank you so much mark.

With that.

Back to open the call for questions.

After the culinary I'll finish with some closing comments.

Because of cold midnight.

Okay and over office is close.

To make this as Expedias as possible my question is asked.

Well in our home offices, so I will ask internal experts to answer your question.

So operator, please go forward.

Thank you as a reminder to ask a question you will need to press Star then one on your touched on telephone to withdraw your question press. The pound key please standby will be compiled the Q1 day roster.

First question comes from Dr., Joe Pink and that's what H.C. Wainwright. Your line is now open.

Hey, guys. Good afternoon hope, you're all well and hope you all stay well.

Few questions. If you don't mind first uninspired, Steve I want to merge two of your prepared comments, obviously as you said the you know nothing new in 15 years, especially in the advance population and then you had your comment that you know based on observations for unblinded data you. It appears to have a slower.

Rate of events versus historical controls, so I'd like to approach that from a Devil's advocate perspective, obviously, you know all of us want to a hope that it's due to the presence of Rigosertib. So I guess from a Devil's advocate perspective, what do you believe could also be impacting that obviously beyond the you know placebo group, where the control group.

Acting better than expected.

But no changes in therapy therapeutic regimens et cetera. So just curious what your thoughts might be.

So Joe Thank you for that question.

Yes.

Experts Devil's advocate Dr., Rick would need to answer your question rents.

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Thank you Steve is that that luster, it's not introduction.

Thank you for the question Joe I think we have to keep in mind.

The historical data regarding survival was collected well over 12 years ago and was not really collected in a randomized controlled trial I think one of the potential factors that could be contributing to the event rate not.

Being what we historically anticipated is improves supportive care that's occurred.

Since that time, they do original agents sided being studies were done in survival was captured.

Think that at this point in time, we do not see any impact coal bid on a survival events, but obviously this is something we're monitoring through our safety reporting process.

And we'll continue to go forward with that looking very carefully on a regular basis at the a bench rates.

Very very helpful. Thank you for that and then I'll put two in here at the same time with regard to the news flow around inspire well based on your goal of hitting a medical conference. Later this year I guess, presumably ash if the data where if you hit the events ahead of time would you anticipate just putting out at more simplistic press release.

That the or maybe the primary had been met and then hold the data to Ash and then secondly based on the relatively late addition of additional geographies enrolling sites like in Brazil are you looking at any potential over enrollment.

So I'll take the first one first Joe if I may so regarding.

Lisa information if you.

No.

It looks like it's a line there and ideally we will present the survival data with ash.

But clearly if we have.

Good day to try to gosh, you will be in discussions with ash.

Form them of our knee based on FCC guides that data needs to be released to the street, how he will do that in a timely fashion by a press release of some slots at the same time make sure we formats that.

The data will be released and yet actually will permit us to present.

The day at that Medical conference and I think you had its second question, Joe I'll ask Rick did take.

Yes. Thank you Joe your question relates regarding over enrollment in inspire now that we've reached 360.

The current industry practice for sponsors is that patients who have consented to the study prior to achieving planned enrollment.

Given the opportunity to be screened and considered the study for participation.

We are doing that we are obviously following closely health authority guidelines, such as the F. Da's wash dwellings national guidelines.

None of those guidelines have yet said that over enrollment with screen patients is not possible. So I anticipate there maybe a few patients that would still come into the study.

Got it. Thank you and my last question and thank you for being patient with me. Obviously, you had some BD developments as well with regard to China rights to Rigosertib from haunt X, but you're obviously still dealing with that company for one to three 300, which is a mouthful you've got to get a better name [laughter], but the.

Just curious how things might be going in potentially re licensing in China and beyond thanks.

Thanks, Joe RV can you take that please.

Sure. Thanks for the question, Joe and you're right, we have an existing programmer hynix biopharmaceuticals the program with Rigosertib. It's now.

China rights are available so that means the largest markets in the world outside of Japan, China, Europe, and the United States I couldn't over maintains all those rights and no Weve license.

Right and the fourth quarter as Steve mentioned to.

Partners in Canada, and Australia, New Zealand those territories very much remain available and as we complete enrollment here and as we approach data. We believe it's gonna be an exciting time on Ah for OCC and over on various frogs, including business development.

Got it thank you very much guys and to stay well.

You too.

Thank you. Our next question comes from Dr., I haven't Amir with noble capital airline itself and.

Hello team. Thank you very much for taking my question is nice to hear every month voice and I hope you're safe and you'll see safe Oh. My first question back first of all congratulations you needed. Some good new congrats on the completion of enrollment.

So.

I think they dying to second half.

Like many genome make any any other types of data that will be pets beneath her presented that at home friends prior to.

Topline data.

Rick Please.

Yes, thank you for that question.

We have submitted an update on genomic profiling from aggregated data of the two arms of the study in inspired to E. H a.

That abstract is under review now, but and as some of you may have heard or some conferences are considering their status to date, we have not had any communication for me ha.

Okay. Thank you very much.

And since I always since we know you love Ras I will also.

Yeah, we now we know what UK ration mutations are the different sub types of K rash.

Jason seen an allocation based on the mechanism of action or Riga asserted that she's not matter, which actually okay rash.

The type of mutation is fab, but we will share that data with the medical community as well.

Okay, that's great to hear it seems I went up.

No.

Cash in hand, what would be.

Khakis moving forward deep names to carry any other assets into clinic or any any differences that we did not seeing that past year would we see anything different age when its money.

Hi, if he would you like to talk about new assets.

Thanks very much of those are the question reason, then I'm a really strengthened position as a result to the recent financing. So we do have options our highest priority is completing and spire and during the necessary and be a prep commercialization after that but we are certainly.

Looking for opportunities or a value or in the strongest position we've been in sometime in that that.

Luxury so thanks for the question.

[laughter], thanks for answering <unk>.

Yes, I will make next question for Mark. So you don't feel left that's either mark.

But would be the outstanding.

20, rainy I believe most of them are.

Not that finding anymore, but I was just curious.

That's a good question I havent, thanks for including me in your questions I appreciate it.

So I think if you saw the details and they are in the press release, we said that we have 5.7 million of proceeds from warrant exercises.

See the full story when we file our 10-K, but of those proceeds mostly I guess all those warrants from since 12, 31, 19 or 20% warrants. So if you do the math you would see that were somewhere in the range of 28 or so million that remain outstanding.

Okay. Thank you ma'am much smart I loved your well [laughter], Justin I'll pass it Oh, the TV for <unk> sake, I N D little bit point compared to previous disclosures. So maybe you could main reason in any way that could be.

Faster than expected.

Sure I'll take that the issue.

Simple, one which is not unusual with a.

Problem with it.

Previously identified manufacturer.

That we felt and he asked you felt it was not up to their standards in rather wages rather than waiting for them to do corrective measures.

They decision to identify a new manufacturer, which was done of course at the time for our quality team to make sure.

They are hot topic over standards in Sta Standish once that's I mean, once that was identified and it was.

Ready to move forward, but it did quite a.

They have a delay, but we think it's worth it.

Thank you ma'am makes everybody have a great ending the looking for with the catching up later.

Thank you out.

Thank you and as a reminder to ask a question you will need to press Star then one on your touched on telephone to withdraw your question press the pound key.

Next question comes from Dr., Yale Jen with labeling company airline is now open.

Oh, good afternoon, guys, and Oh with Youre, keeping safe and that keep continues to be safe and thanks for taking the questions.

First thought that.

The your mail me now answer the question, but just curious what the current event <unk> of the inspired study right now.

Then numbers.

Studies, I know and though lucky view the confidence that Ah you will have that result, I mean that BD study be completed by.

A second half of this year.

Sure.

They said.

Yes. Thank you. Thank you for the question.

Currently over 85%.

The required.

That's right.

To proceed to button on the endpoint analysis based on our tracking.

Oh the advance rates.

Over the past years.

We're confident that we will meet the required number events in second half 2020.

Okay, Great. That's that does that's very helpful and my second question is that the oral.

A combination drug.

They suits me study you just mentioned on your prepared remarks that won't be study was started in conjunction with.

What the meet up the inspired study.

Just curious whether you anticipate to start to pick that up phase twos three study.

He fall or maybe or are you on feet that afterward, so data readout.

Well I'll take that actually yeah, but as I mentioned, it's going to based on indeed.

You a complete our protocol submitted to the asked yet.

Have their reviewed there's always going to be given cake guiding a study and optimization, we need to meet with GFT age, we anticipate approximates always hard to tell with precision.

One deal now lung patients, who will do we anticipate that show.

Probably be about simultaneous with the read outs from the inspire survival data. So that's our best estimate but of course could change.

Based on a number of factors.

Of course is determined by how long patients live which is a little bit.

Difficult to precisely say.

Okay. Okay, that's cuts, but didn't know and maybe one more question here, what's the sort of unfortunate effect up be covance 19th.

Actions, mostly vulnerable is older.

Patients so given the age group up the people in this study.

Yeah.

Do you think that could potentially.

I get a thought already you know di di di di time, all read out Ah Ah just based on these Ah Ah so fundamental.

<unk> characteristics that patients.

Correct.

Rick.

We made wash mix, yeah, just succinctly what did you quantify now sorry, yes, okay. Okay.

I'm sorry.

For that.

As you might predict it's hard to predict for event rate.

He actually impact to covert 19 on this patient population in our study.

Somewhat precarious to date, we've not seen any dramatic effects and but we'll continue to monitor the situation.

Okay, Great and again I think for answering all these questions and that keeps safe and though we look forward to see a read out and starting the trials or they don't this year.

Thanks good.

Thank you when we do have a follow up from Dr., Japan candidates with H.C. Wainwright. Your line is now open.

Hey, guys appreciate taking the a follow up here, Steve even part of your prepared comments, you're focused on pipeline development and expansion. Obviously, so I guess I always want to ask some some of your behind the scenes activities. You know not just sitting around waiting for inspired to read out, but what you're doing behind the scenes with regard to say you know.

Pre commercialization activities, what you're looking out for a potential M.D.A. Pratt timing for Andy a prep those sort of things. Thanks.

So I'll I'll take that number questions actually in there Joe right.

One other thing to be doing things, we believe rigo shirt has many older potential indications.

Okay, Ras driven cancers. So as you know based on these remarks and not be prepared Joe I do it off the cost by the way so.

Okay rash mutated lung cancer.

One disease, Arkansas first attack, but there are variety of diseases, we want to look at.

And how do we have the funds we could do it as a variety of approach is most likely investigator initiated trials, but those that are of interest to us a melanoma.

Refractory myeloma.

Oh, right evolve neurofibromatosis Ciscura Cyto Cisco dual.

Rash.

Yeah.

Regarding the N D a threat.

We are in the process of looking at candidates you on regulatory affairs on behalf of block and older.

Looking at expert San Diego.

Oh organizations that all they do you submit and de A's and.

We plan to work with them so.

So we can expedite.

Already working on your part somebody and do you probably know you don't need the clinical data so the preclinical story.

Manufacturing.

Walk in stock we started on already.

When we slipped a card and hopefully I've a positive survival results down because yes.

The clinical data into that report obviously other previous studies also have to be part of the idea and all that work can be done and finally with getting or advice regarding the commercialization.

What needs to be done what our GAAP analysis is so we are in <unk> and discussions with commercial experts getting their advice. So we can move forward on that passion as well I.

I hope that answers your question Josh It certainly does Steve Thanks again for the follow up.

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

[noise]. So thank you all for participating on todays update call.

Neely, we're very excited about the progress we've made with Ivy League asserted.

And our pipeline programs overall.

And I hope you share our enthusiasm.

Important milestones, we look for in the near and medium term include and this lifting is in no particular water.

What.

Initiating enrollment.

The phase one two age trial.

We go search it wasn't a blow them that.

Okay wraps mutated advanced non small cell lung cancer as me Nisshin investigator initiated trial.

Sure.

Beginning a space to slash read combination study.

Oral rigosertib and age decided the.

He's jumei nicely higher risk Mds patients.

Junction inspired data readout.

Three.

You asked I N D submission.

Oh in 1233 and you.

During the fourth quarter 2025.

Followed by clinical trial initiation.

And of course, most significant me.

And the data release for great enthusiasm is number four.

During the second half of this year.

This top line survival data.

It's running inspired trial, following reaching 288 survival events.

That concludes my closing remarks.

Oh.

We truly appreciate your continued interest in the programs that aren't you know.

Should you have any additional questions.

Please feel free to contact us and thanks again.

Operator.

Ladies and gentlemen, thank you for your participation on today's conference call. This concludes today's event you may now disconnect.

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