Q1 2020 Earnings Call

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Ladies and gentlemen, thank you for standing by welcome to the copper concert Pharmaceuticals first quarter 2025 to results call.

At this time all participants are in a listen only mode. After the speakers presentation. There will be a questionnaire. So session to ask a question during the special needed a press star one on your telephone if you require any further assistance. Please press star one zero I would now like to use recipes couples clubs Justine koenigsberg getting one about it.

Good morning, and welcome to concert Pharmaceuticals, first quarter 20 Twond.

On the Investor update.

Joining me. This morning, we prepared remarks that Roger Tom I, President and CEO, Jim could sell out our Chief development Officer, and Mark Becker our CFO.

He will also be joined by Nancy Stuart Our Chief operating officer for the Q in a portion of the call.

As a reminder, today's discussion will.

Well include forward looking statements about our future expectations plans and prospects. These statements are subject to risks and I'm sorry.

Certainties that may cause actual results to differ materially from those projected a description of these risk factors can be found in our most recent 10-Q filed with the FCC any forward looking state.

And then speak only as of today's date and we assume no obligation to update any forward looking statements made on today's call with that I would now like to turn the call over to Roger.

Thank you Justine.

During the past quarter throughout 2019, we've achieved positive developments that position concert for important clinical milestones and value creation in the months.

And your head.

For teams worked diligently to advance or two proprietary programs both of which at the potential to be in late stage clinical testing next year.

It's impossible not to look beyond our business is global citizens Americans neighbors friends and family.

Consider held.

Colby 19 endemic has impacted so much in award.

First we're proud to be part of an industry that takes as its mission.

The development positively life impacting medicines, and we salute to companies that have stepped forward to develop therapeutics and vaccines for Colby. Thanks.

We've also we also have to acknowledge that Genvec will have brought impact on companies conducting clinical trials.

Also in other indications.

In our remarks today will provide an update on the development status of our two clinical candidates in light of Colby 19.

We've been in close touch with our clinical sites and kill well advisors and our monitoring the situation in real time.

Todays update is subject to reassessment as coconut.

Hi, Jane runs its course throughout the U.S and other territories in which we have ongoing or planned clinical operations.

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First let me cover CTP 543.

We are highly focused on addressing the need for an effective treatment for all Piceance Harry auto for the favorable safety profile, we're continuing to advance 543 to meet this product profile and bring it to be.

Dave any control trial.

Based on these results, we feel as possible for CGP 543 to be in.

Fully entrant in the LP Sherry auto market.

The potential to have a very favorable product profile.

We remain on track to initiate a phase III clinical trial in fourth quarter. This year.

Now turning to CTP 692, our candidate for schizophrenia, we believe that CTP 692 has potential to improve on the primary symptom domains in schizophrenia.

Including positive and negative symptoms and cognitive function when added to existing antipsychotic treatments.

The dose ranging phase two study got off to a great start enrolling patients, but you did Colby 19, we now project completing enrollment for the year end, Jim will describe status of activities with our clinical trial sites and how we are working to support completion of this trial.

As is.

Stated earlier, the company's accomplishments over the past year have enabled us to reach the starting point with both of our proprietary clinical programs.

Although we are well aware of the challenging times were facing in our communities and with our programs we're focused on the future.

With the longer term view our belief is.

The potential value of our drug candidates for two important diseases, which affects millions of people alopecia areata in schizophrenia is unchanged.

Good morning.

Of our financial results before we open the call to questions.

Thanks Roger.

Let me start with CTP 692, and some further discussion about our phase two clinical study.

This is our ongoing clinical study that like many other clinical trial has been impacted by Koby 19 and policies put in place to control it spread.

Here's where we are today.

We were on track to enroll patients in time to complete read out the phase two study this year up until the koby 19 virus and related policies pretty significant toll on recruitment activities and conduct of all clinical programs across the country.

With the overshadowing of restrictions related to cope with 19. Our study sites have continued to work within all the federal and state guidelines to complete this study visits in person or remotely for patients already enrolled in this study.

However, as you might expect screening activities for the enrollment of new patients have slowed or been temporarily suspended at our centers.

With this temporary disruption in the screening and enrollment of patients we expect to complete enrollment of the phase two study by year end.

Looking at the bigger picture with CTP 692, we believe we have a drug candidate with very compelling potential for treating schizophrenia, a major disease that affects millions of patients.

We are hopeful.

On that by amplifying or extending the effects of the current antipsychotic agents with CTP 692, we can more comprehensively treats get your fenia and provide greater benefit to these patients.

As we turn to the clinical program for CTP 543, I'd like to spend a few minutes. This morning to provide an overview of our plan CTP 543 phase three program and Alipay share Yada and make a few comments on the data we've generated thus far.

As a reminder, we are developing CTP 543, as a treatment for moderate to severe allergies shariati.

We're very excited about the prospect of this program.

Based on our discussions at an end of phase two meeting with FDA, We're planning to conduct two randomized double blind placebo controlled phase III trials in adults to support our end da.

Patients will be randomized to receive one of two doses of CTP 543 or placebo.

In our phase two dose ranging trial that was completed last year patients treated with either eight milligrams twice daily for 12 milligrams twice daily of CTP 543 met the primary efficacy endpoint more specifically the primary endpoint showed statistically significant differences relative to placebo.

In the percentage of patients, achieving a 50% or greater relative change from baseline at 24 weeks using the severity of allocation tool or salt. We also saw significant at more stringent response threshold as we look more closely at all the salt generated data.

With that backdrop, let me highlight several key aspects of our planned phase three program.

Given the effects observed with both doses in phase two.

Intend is this study both the eight milligram and 12 milligram twice daily doses and ultimately seek approval of these doses to that patients and clinicians will have dosing options in real world views.

We intend to randomize about 700 adult patients with moderate to severe alipay shariati per trial at sites in the US Canada in Europe.

The primary outcome measure for the phase three program will be the percent of patients who achieve an absolute salt score of 20 or less following 24 weeks of treatment.

Since salt is a measure of scalp hearing loss a salt score of 20 means that patients has regrown sufficient hair such that they have at least 80% scalp here presence.

Our analyses of the salt data from our phase two study showed that patients receiving either the eight milligram or 12 milligram twice daily dose of CTP 543 were statistically superior to placebo patients in terms of achieving a salt score of 20 or less.

We have worked for several years to advance CTP 543, and the team here is very excited about this.

Okay candidate moving to pivotal testing.

We have a solid understanding of CTP 540, threes activity and Alipay Sherry Ita and believe we are well equipped to deliver in phase three and ultimately offer patients a safe and effective treatment for Alipay shariati.

The pause here and turn the discussion over to Mark.

Thank you Jim as I review, our first quarter 2020 financial results. Please reference the financial tables found in today's press release.

Research and development expenses were $14 million during Q1 2020 compared to 15.8 million during the same period in 2019, a decrease of 1.8 million.

The decrease in research and development expenses relate.

It's primarily to the completion of the phase two dose ranging study and related pharmaceutical development for CTP 543.

As we move through 2020, we expect that R&D expenses will increase as we continue to develop CTP 692.

And prepare to advance CTP 543 into phase III testing in the fourth quarter this year.

General and administrative expenses were 4.7 million during Q1 20 compared to 5.6 million for the same period in 2019 decrease is primarily attributable to decreases in legal expenses.

Our net loss for Q1, 2020 was 20.5 million or 70 cents per share compared to a net loss of 21.8 million or 93 cents per share during the same time period in 2019.

Finally, we ended the first quarter of 2020 with 159.6 million in cash cash equivalents and investments at the end of January we completed a follow on offering of common stock and pre funded warrants with net proceeds of approximately 70 million.

As a result under our current operating plan, we continue to expect our cash to fund the company into the second half of 2021.

Despite the challenges we are all facing as a result, this coded 19th the ongoing execution of our business makes us optimistic for 2020, which we see as a year of significant milestones for our company.

This concludes our prepared remarks, and we would be happy to address any questions.

Ladies and gentlemen, if you have a question or comment at this time. Please press Star then.

And the one key on your touched on telephone. If your question has been answered or you are seeing what yourself from the Q. Please first the balance sheet. Our first question comes from Maury Raycroft Jefferies.

Yes, Hi, this is off net on formulary. So just a couple of questions. One is regarding 543 phase three.

In Fourq you out of that any gating factors described the side, but as of August.

Okay, then you'll get to though.

Jim could you take that.

Sure Hi, good morning, yes. So.

We had we had great meeting with the FDA we have.

Clarity on our phase three protocol at this point in time is going to be the logistics of getting the trial going.

The Cobiz 19 is clearly one of the influences in in getting the trial up and running so as we see greater clarity around the the other pandemic, we'll be able to make our very firm plans to start.

Trial in Q4, but we don't expect any any difficulties in doing that.

Okay, Okay thats it.

And one quick.

Yes.

Our our guidance now is that we'll be able to complete enrollment by year end and so our our data readout will will occur in.

More than likely in 2021.

We we have.

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Our sites are.

Our.

I have been operational we've done as much as we could to really help them out.

During the pandemic. So as you can imagine some sites were slowed and some sites had too.

Really.

Slowdown on enrollment so I think we are anticipating a.

The completion of enrollment at the end of this year and then we'll be able to wrap up the trial I think as we talked before we.

With positive results here, we will plan on having a and the phase two meeting with the FDA. We think this is the only trial, we need to do for phase two dose ranging trial and we would anticipate.

Starting the phase three trial after discussions with the FDA in the phase two meaning.

Okay. Thank you.

Hi.

Certain comes from Joon Lee with Suntrust Robinson.

Hey, guys and thanks for taking my question is on congrats on the progress so far when will you know if you definitely channel turn our proceed with the phase three outpatient study in the fourth quarter and what.

Sure breakdown.

Yes, Hi, John.

I'm sorry go ahead Roger.

No go on Jim.

Yes, Hi June so.

I think I think were.

We're in good shape to start in the queue in Q4, given the current status of things.

In the World you know our phase III trial will be.

Run in.

US Canada and Europe.

And as we look forward.

Into the later part of this year I think the anticipation is unless things get worse again with Koby 19, we are in.

Good shape from a planning perspective too to start in Q4, so again unless there is.

Downward trend again with the virus I think we are in really good shape.

I think the FDA has put out.

On Guidances for current trials are ongoing right now in terms of flexibility and providing as much guidance as eight can right now in terms of what's going on with.

Okay.

I don't know, what's going to happen once we get beyond vis vis crunch period with coated in terms of regulatory expectations, but yeah. We have a fully developed program. We have a lot of data we are continuing to track the trials that we need.

To do in relationship to NGL approval so.

We have a good we have a good plan here and.

And we will be able to execute that plan as things open up a little bit more.

We are.

We have a number of sites that we've been working with for our phase two program. We obviously will be expanding the number of sites for phase three.

We are.

Feeling very confident that the sites we are selecting.

Both here and abroad are going to be sites that will be able to.

Due to this study and I think Thats really were emphasis is right now and preparing for the start of the phase three.

Soon I would not guide you to expect of a a change in the regulatory approval pathway, though I think.

Our expectation is that this will be.

In the eight milligram VIP and 36% in the 12 milligram be I'd would have had so score offline.

So 10 compared to 2% into placebo as that is at a fair way to understand.

The outcome because I'm just trying to.

Freemium swinging it this way because the endpoint interface means less than 20.

Yes, so im sorry, I don't have grab so yes go ahead Jim.

Yes, So June the.

Our average in the phase II.

So our average baseline score was about 88 ill give or take and yes, you're right. So so that that's a fair amount of hair loss.

Coming into into the trial and I think the way that you could look at this is we have this all assessment tool.

Well, which allows us to cut the data in lots of different ways. So when you look at the folks.

Who have had based on the data that we have shown previously in terms of percent change from baseline.

We did have 36% of the 12 milligram group have.

90% or greater change from baseline so looking at an absolute score score likes all 20 of course, we were able to to look at that.

We did say that we had.

Significance at this all 20, and we were going to be presenting that data.

At the meeting that meeting is now going to be a virtual meeting so we'll be able to present, our new data analyses.

Had a diesel you'd be able to see those data, but we will.

We powered our phase three study based on the analysis that we were able to conduct.

From our phase two trial using this all 20, specifically so so the powering for the trial is really based on what we know about.

Achieving this endpoint and and I think the data that we presented so far doesn't quite show you that but it will those data will be presented.

At the.

The meeting.

Has that has a date.

Question comes from Adam Walsh with Stifel.

Hi, Thanks for taking the questions on the.

Adam.

I understand you have a fix to extension study for CTP back all three.

We expect any data from study this year what is the dosing regimen you. This.

Extension trial of these patients switching to the VIP dosing Thats you plan to using increased three.

Hi, I have a follow.

Yes, Hi, this is Jim So we do have an extension trial ongoing it's.

The patients from the 12 milligram cohort as well as our other phase II studies were eligible to rollover into the extension study. This is a long term extension study that we had been running now and the the subjects were.

Were rolled over into it either onto the eight milligram VIP or 12 milligram.

Dose.

Seeing regimen.

So there are two doses actually there are two doses in that study.

We expect any data readouts of victory with you.

Yes.

We haven't discussed when we're going to be talking about data from that study. It is a long term study.

So we havent decided when we would or if we would.

Start showing any of that data, but I think it's fair to say that you would not anticipate releasing any of that data this year.

Okay. My second question.

Second lump on non handset Pete.

Can you help us understand the timeline here.

And we expect.

The decision from the panel of judges have jobs.

Q.

Yes, Im sorry, say that we can't provide very much guidance on that this is.

As you as you understand and unprecedented situation with having the so.

Remains going back to feature.

We expect that so they'll probably try to act on it.

Hi, relatively soon but we have no basis to give any specific guidance.

Okay. Thank you.

Thanks for the questions.

Our next question comes from Liisa Bayko with JMP Securities.

Hi, guys O'neill on for Lisa.

Further CTP six when to that.

Safe to say can you say the data will be first half of 21 or not sure yet.

And then second question. The good news I think is that dermatologists psychiatrists relative to other specialties.

More likely to be able to do the kind of job virtually.

Any reason to think differently in terms of a clinical trial setting.

Thanks.

Jim.

Yes, so I think that down.

I think that the SEC.

Hi interest in that ended dermatologists that we're using for our studies are well equipped to.

To do the work that we're doing right now I think the.

The virus has had some impact on in terms of overall logistics and things, but I think we've been able to really maintain things in terms of the 672.

Trial, which is.

Which is really the active trial that we're running right now we've had to work with all the sites to see what they needed and I think.

They are mostly psychiatry centers are very well experienced and were able to really.

Make sure that they they had what they needed to maintain their activities.

I'm, sorry could you repeat the first part of the question.

Just the timeline 2021 should we say first half are not sure yes, yes, so for down yes, yes, so I think.

I think if we're on track to have enrollment completed.

By the end of the year I think the first half is a reasonable expectation I think it's still depends on.

The impact of the virus, but if you if we can complete the enrollment by the end the year I think first half is reasonable expectation.

Got it thank you.

Again, ladies and gentlemen, we have a question or comment at this time. Please press the star than the one key on your Touchtone telephone.

Our next question comes from Aster Hong journey.

Hi, Good morning, Sean CTP six nine to ask for schizophrenia is there to potential for any missing data because of.

Yes.

I cover 19 pandemic and maybe follow up Paul.

Thats around the trials does this impact any powering assumptions.

And then on CGP aside for three for ALN Pcs.

Any developments in other cases that have been similarly romantic thanks.

Hi, I'm sure I'll talk about the 62.

Look.

I can't get into logistics in the actual details of of the trial, but let me just say that we've done everything we possibly could.

To maintain the integrity of the trial.

With the.

The guidance is issued by the FDA.

It did allow for flexibility around remote assessments.

And I think it's fair to say that we've done everything possible.

Within the scope of all the guidance is to maintaining integrity truck.

Our secondary adjudication or reduce indication of of all of those studies so for the trial so.

We're in a wait and see kind of mode I just want to really emphasize that so.

Regarding the conduct of the CTP 692 study Jews group has done a tremendous job of keeping things moving forward under leach very challenging conditions and.

Well, it's difficult to assess the future I think we're feeling really good about where the trial is right now relative to.

Our initial concerns so it is continuing to move forward, we are continuing to.

Well, new patients and if things move in.

The.

Trajectory that they had to date I think that.

It's a study will.

Move forward.

Quite well.

Great. Thank you.

Our next question comes.

Eric.

Okay.

Okay. Thank you my question.

Just a quick one based on available clinical data from the serving scale clean year.

Correct assumption now, we should be equating to Sac and an active side I think.

Okay.

Yes.

Okay.

Well.

Yes, hi defect.

I think the literature, showing a very nice.

It sounds Theres also been being a very.

Positive symptoms and in some cases on on the cognitive functioning I think that has really.

Really reinforced.

Sure, which is to look at the total Pan score, which captures all three of those things of course.

As we've discussed in the past, we will be able to go in there and look at the effects on negative symptoms in positive symptoms, specifically by the way that the Panza design and will also be able to look at those questions that are related or those items that are related to to cognitive functioning. So.

I think you're right. The assessment of the literature is that there's been a very favorable effect on negative symptoms I think thats, one or the hallmarks of these hearing. It's also one of the things that were very much interested in.

But because of the nature of the de Syrian mechanism and its ability to really impact all the symptom domains.

Thats why we looked at the total score.

We will.

Welcome SEC.

I really think that each of the products and each of the patent is a case by case situation with different facts around.

Funding them is your were with respect to.

CTP 692 were not pursuing a composition to better patent on it so that that the comp.

Position was.

As has been known as the literature, what we're relying on in that case is the unexpected properties of the comp on talks logically.

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We're not aware that theres ever been a case, where a jury modified compound is head.

Strongly positive toxicological characteristics, particularly renal chalks relative to a non deuterated compounds that.

Some.

Singular observation, we think provides a very strong basis for.

The odds of use in a variety of different conditions as well as potentially pharmaceutical compositions.

So it's very different kind of of legal situation.

And with respect to 49.

Nice should also note that with respect to 249 that we do have the subsequent issuance of the 659.

Patent which was.

In light of.

Knowing that there was the ongoing litigation around 149, so we think that the us.

Subsequent patent on CTP 543, which.

Projects pharmaceutical compositions methods of Houston specific dosages of it is.

Is an important patent that provides independent protection.

That really reduces the.

Impact in importance of the 149 litigation.

Thank you I guess, let me add further clarification.

Sure. Thanks Steven.

And im not showing any further questions as long as I turn the call back over to Justin.

Thanks, Kevin we'd like to thank everyone for Jim.

Joining us this morning, and look forward to continue to provide.

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