Q1 2023 Aclaris Therapeutics Inc. Earnings Call

May 8, 2023

Okay.

Good day, and thank you for standing by and welcome to of Clarus Therapeutics first quarter 2023 conference call. At this time all participants are in a listen only mode.

So there'll be a question and answer session to ask a question you will need to press star one on your telephone you will then hear an automated message advisor in your hand, it's ways to remove yourself from the queue. Please press star. One again, please be advised that today's conference is being recorded I would now like to hand, the conference over to your speaker today, Robert duty Shadow Investor Relations.

Please go ahead.

Thank you I am Robert duty head of Investor Relations for our Claris. Please note that earlier today, we issued a press release, highlighting our first quarter 2023 financial results and other business matters.

For those of you who have not yet seen it you will find the press release posted under the press releases page of the investors section of our website www of Claris, TX Dot com.

In addition, we will be referring to a slide deck entitled Q1, 2023, Investor Conference call, which can be found on the investor page of our corporate website and furnished as an exhibit to our form 8-K that we filed with the SEC earlier this morning.

Joining me today for the call are Doug Martin, our Chief Executive Officer, Gail Cockwell, Our Chief Medical Officer, Joe Monahan, Our Chief Scientific Officer, and Kevin <unk>, Our Chief Financial Officer.

Before we begin our prepared remarks, I would like to remind you that various statements. We make during this call about the company's future results of operations and financial position.

Business strategy and plans and objectives for our claris future operation.

Are considered forward looking statements within the meaning of federal Securities laws.

Our forward looking statements are based upon current expectations that involve risks changes in circumstances assumptions and uncertainties that could cause actual results to differ materially from those reflected in such statements.

These risks are described in the risk factors section of <unk> Form 10-K for the year ended December 31, 2022, and other filings of Claris makes with the SEC from time to time.

These documents are available under the SEC filings page of the investors section of <unk> Web site Www of Claris, TX Dot com.

All the information we provide on this conference call is provided as of today and we undertake no obligation to update any forward looking statements. We may make on this call on account of new information future events or otherwise.

Please be advised that today's call is being recorded and webcast.

A link to the webcast can be accessed under the events page of the investors section of our website.

I'll now turn the call over to Doug.

Thanks, Bob and good morning, everyone.

I Hope you had a great weekend. It is my distinct honor to be speaking with you today following not only my first quarter as CEO , but also the first quarter of operations for our new leadership team.

For those who may be newer to the Cara Therapeutics story, we were originally founded as a specialty pharma company focused on clinical logic condition.

It was a great credit to my predecessors, but a few years ago. The company made the decision to acquire concept life Sciences based in St. Louis.

The addition of this world Class Discovery group focused on the human kind of a lot of claris to pivot its focus on research and development efforts towards addressing areas of serious unmet need in immuno inflammatory diseases with oral or tissue specific agents.

As evidenced by a number of recent significant transactions in the resi space, including Pfizer's acquisition of Arena Takeda is acquisition of the Nimbus pick two program and Merck's acquisition of Prometheus, There is tremendous opportunity for significant creation of shareholder value in this space.

Find ourselves in the enviable position of having several key clinical stage asset targeting these potential diseases.

Led by our potential first in class MK, two inhibitors met to nib or ATI 450.

If you could direct your attention to slide three in the slide presentation, we can discuss the agenda for our call today.

We're very pleased to be speaking with you today to provide an overview of our first quarter financial results as well as an update.

Our timing and plans for the remainder of the year.

I'll begin by providing a few opening remarks on the company's performance to date for the year and then we'll turn the call over to Gail will provide updates on all of our progress across our clinical development programs.

Following that update Galen, Joe will provide an overview of the final results from the trial in hidradenitis Suppurativa or Hs.

For which we reported topline results back in March.

Kevin will then provide an overview of our financial results for the period and finally ill provide some closing comments prior to opening up the call to address your questions.

Overall I am very pleased with performance of our company through this first quarter of 2023, our team is making tremendous progress advancing all of our various clinical development program, which is a testament to our team as we are a relatively small company in terms of size and overhead.

I also remain impressed with our team's ability to continue to execute global clinical trials in a challenging macro environment that is continually tact by economic downturn took supply chain and global conflicts.

Despite all these headwinds our team is continuing to prosecute these studies and demonstrating creativity and flexibility in the face of hurdles when they arise and for that I could not be more proud.

During the first quarter of this year, we completed and reported the topline results of our phase Iia trial of ATI 450 NHS.

Although we were disappointed that the <unk> results were not what we had hoped for in this challenging and so relatively misunderstood disease. Our team delivered on time, a well executed trial.

Importantly, this trial further expanded our experience and understanding of ATI 450.

The completion of this study is further demonstrated the foundation for the program from both the safety and Pharmacodynamic perspective going into our next data readouts in rheumatoid arthritis and Psoriatic.

Sorry attic arthritis.

As a reminder, our company already had positive proof of concept data in our rate from our prior phase Iia trial.

Shortly Galen, Joe will be providing more details of the final results of the trial with a focus on how they inform our continued execution of the rest of the ATI 450 program.

With that I'm, not going to turn the call over to Gail to begin the discussion on clinical development progress.

Thank you, Doug and good morning, everybody.

I wanted to take a moment to commended claris team on the execution of the hydrogen that is to breakeven.

Also on the tremendous work they've done in recent weeks to fully analyze the results from this study.

Thus, enabling us to provide you with today's.

Directing you to slide four the summary of our development pipeline, let's start with our phase one stage clinical asset HCI <unk> and <unk>.

K JAK <unk> inhibitor.

Building on the successes of the API 21, 38, Sealy sending dose study.

A lot of delay ascending dose study in healthy volunteers continues to progress well.

We are very much on track pharmacokinetic Pharmacodynamic and safety results in the second half of this year.

As we previously announced our first clinical trial of ATI 2138, and a patient population is planned to be a phase Iia proof of concept study in ulcerative colitis.

The planning is well underway. So that we can be in position to initiate quickly upon completion of the ongoing multiple ascending dose study.

Later this year, we will provide you with more details on the ulcerative colitis study. After we have the phase one results and is fully finalized the design of this proof of concept study.

Moving on to HCI 22, 31, our next generation MTO to inhibit <unk>.

Moving closer with our prospective epidemic.

Getting to the ultimate objective of setting Hei <unk> 31 in metastatic breast cancer and in pancreatic cancer.

Now shifting to slide six.

For ATI 17, 77, our topical JAK <unk> inhibitors.

Inhibitors, which was designed for skin efficacy and minimize systemic exposure. We are conducting a phase <unk> study in atopic dermatitis as a follow up to our successful phase Iia study.

The objectives of the Chile, I, just further evaluate the efficacy and safety of ATI 777, and validate the limited systemic exposure.

In the Phase Iia study.

We are also studying several dose strengths, including the 2% twice daily dose studied in the phase Iia trial in several lower dose strength as well as assessing once and twice daily applications. So that we know which formulation regimen will be best for progression into phase III development.

Yeah.

We also extended our study population in this study to include children down to age 12, given the importance of this disease in children.

The primary endpoint of the trial is percentage change from baseline in the eczema area and severity index score for easy score at week four.

The target enrollment of 240 patients.

We've been very encouraged by the success seen recently with other topical therapies in a broader array of patients and then meaningful medical need in some milder patients.

As such we recently extended the protocol to include not just moderate and severe atopic dermatitis, but some mild patients as well.

And we want to ensure we can enroll adequate mild patients to meaningfully evaluate them.

This protocol modification is also important because as some of you may have seen reported from other companies conducting trials in atopic dermatitis enrollment. This past winter season has encountered some challenges, particularly driven by the mild winter in many locations, particularly in the southern and <unk>.

Eastern portions of the U S.

Since the Chinese associated with cold winter weather and Keybank can exacerbate atopic dermatitis.

And the first few weeks of this protocol amendment, which just went into effect, we've already seen a meaningful increase in screening.

We are updating our guidance in terms of timing of topline results to move from our prior guidance of mid to second half of this year.

And we will tighten up that guidance as we continue to learn more about the impact of the amended protocol.

Moving to slide seven as a reminder, in our phase Iia trial Hei 17, 77 achieved statistically significant results in the primary efficacy endpoint at week four.

And positive trends were observed.

Secondary endpoints, including improvements at each percent of modified easy 50 responders.

Responder analysis and reduction of body surface area impacted by the disease.

Shifting to slide eight importantly, ATI 777 with observed to have a favorable safety and tolerability profile.

And because of the SaaS tactical approach very low plasma levels of Hei 17, 77 was seen following the tactical application.

With the average concentrations in patients never greater than 5% as the IC 50 of Jacquin, three and only three patients have concentrations greater than 110th the IC.

Now moving on to Hei for 15, we will begin with a more comprehensive overview of the Hs trial now that we have the full dataset.

As you all know from the topline results that we reported in March <unk> did NASA.

Primary or secondary efficacy endpoints in Hs.

As shown on slide 10, we randomize 95 patients into the study with 47 on placebo and 48 and <unk>.

Overall with 32 patients on the placebo arm complete the study in 2006 on active treatment.

As previously noted the study did not demonstrate efficacy for ATI 450 in the treatment of Hs <unk>.

A modest effect, which was overshadowed by an unusually large placebo effect.

I do want to spend the majority of our time today on the elements from this trial that can be applied to our understanding at ATI 450 overall.

These elements primarily fall into two buckets.

50 and pharmacodynamics.

I will discuss the safety elements in detail and then Joe will discuss the pharmacodynamics.

Slide 11 shows the steady demographics and baseline characteristics.

We are quite proud that we enroll the trial that was very representative of real world Hs patient populations with more inclusion of historically underrepresented people.

From a safety perspective on slide 12, we had no serious adverse events on Hei's with 15, New series, and Oregon, Toxicities, and no serious or opportunistic infections.

What we did see unsurprisingly given the lack of efficacy is a meaningful number of early discontinuation from treatment shown on slide 15.

Overall, we had 15 patients in the placebo arm.

<unk> active arm discontinue from steady treatment.

And we saw high discontinuation starting in the early days of the trial.

And this observation was the primary reason we made the decision to increase the enrollment last fall.

Withdrawals due to loss to follow up withdrawal of consent and investigator stated lack of efficacy were relatively balanced between the <unk> and the placebo treated arm.

The divergence in discontinuation with notice fluids trials between the adverse event with four with strengths in the placebo arm and 11 from Hei for Visteon.

When we dug deeper however, we noted that the majority of patients in the active arm, who was due to an adverse event.

Seven of the 11, we're not seeing treatment related efficacy.

They are an at least either worse or no better started study.

While most of the adverse events, leading to discontinuation of treatment with only moderate in intensity. It is not surprising that patients who were not seeing the benefit has little incentive to continue treatment.

Further the adverse events that led to discontinuation when most commonly related to worsening Hs.

New coin absence.

Titanium abscess are worsening estimate which is closely related to Hs.

We also had a few subjects with dry Utica headache, or dizziness, which is a known phenomenon that occurs in some patients early in the treatment period and typically in Lasalle, even when patients continue treatments.

And with further investigator education on this topic, we saw no further discontinuation is for this reason.

And of course, we also provided this education to investigators for the ongoing rheumatoid arthritis psoriatic arthritis trials.

It's important to note pertaining to a carrier take arthritis trial, well into an advanced stage of our enrollment process and we are seeing a discontinuation rate in the trial that is quite stable and below our model projections when we initiated the trial.

Now, let's move on to the other topic that captures the attention from the top line results.

<unk> and creating phosphor kinase or CDK, which is shown on slide 14.

When we issued our press release, we noted that there were 10, 4% or five patients that had reported treatment emergent adverse events.

Elevated slide CK levels.

Subsequent to top line as we finalized our data.

And that one of these patients had their elevated teekay prior to receiving study drug. So this was not a treatment emergent events and as such that patient has been removed from that category, which brings the percentage booked down below the 10% threshold that we reported.

Overall, though CK elevation work habit in patients both on ATI 450 and on placebo.

With 19 patients with reported elevations of CK levels and laboratory dryers during some points in the study.

Six of these were on placebo and 13 on Epi for 50.

The majority of these were modest elevations. However, as you can see unsteady trials. We also had three great too.

Two grade three and one grade four CK elevation.

However, moving to slide 15.

And then imagine CK elevation that were great too and above where most typically trends in analyst typically returned to baseline even when patients continued on treatment.

Many of them were associated with a history of exercise.

More importantly is what the CK elevation, we're not associated with there were no associated adverse events that would suggest something more severe was going on for example, no we're putting muscle pain.

Ms kidney abnormalities or CK elevation that were not from the skeletal muscles.

We do know that benign CK elevation has been seen with other effective anti inflammatory treatments like TNF inhibitors and JAK inhibitors.

Moving to slide 16 overall to date, we are very pleased with the safety profile, we see with <unk> through the current stage of clinical development.

Adverse event profile has continued to be as expected we've.

We've seen transient CK elevation in some patients at generally disappear with continued treatment and you.

Do not have any muscle related symptoms.

We've seen no meaningful effects on kidney or liver or cytopenia is no serious or opportunistic infections.

Lastly, it is important to note that in preparation for phase III, we've completed our chronic toxicology studies and with all of the POS allergy results now available there are no issues of concern identified.

With that I'd like to turn the call over to Joe to discuss a pharmacokinetic and Pharmacodynamic findings from the Hs study Joe.

Thanks Gail.

Good morning, everyone. Let me start by saying that at the outset, we believe Mechanistically ATI 450 had a chance of demonstrating efficacy in the Hs study.

However, we believe it is likely that the disease is perhaps driven more locally in the skin than through systemic pathways.

I would now like to share what we've learned from the Hs study pharmacokinetic and Pharmacodynamic analysis.

Briefly the PK for ATI 450, behaved as expected with a modest accumulation across the first week of dosing and peak and trough drug levels similar to those observed in the phase <unk> study and the phase <unk> study.

For PD, we took two approaches to understand ATI 450, pharmacodynamics in Hs patient blood as shown on slide 18.

First we conducted an analysis of cytokines and ex vivo stimulated patient blood on a small sample subset of five patients from two sites.

We compared samples from both placebo and ATI 450 treated hs patients with healthy donor controls analyzed in parallel.

We looked at for pro inflammatory cytokines TNF Alpha IL, one beta IL six and IL <unk>. After the first dose and then again at the end of the study.

If you direct your attention to slide 19, you can see we provide side by side comparisons across three of the ATI 450 studies completed to date.

The seven day Mad study in volunteers to 12 week already Phase Iia study and the 12 week Hs study.

ATI 450 inhibited all four cytokines analyzed while the data shown focuses on inhibition of TNF Alpha and IL one beta.

On day, one near complete inhibition of these two pro inflammatory cytokines is observed across all three studies, suggesting that their production healthy subjects already patients and Hs patients is similarly dependant on the MK, two pathway and sensitive to ATI $4.

<unk>.

Also important to note here is that ATI 450, Potently inhibits these cytokines at the end of each dosing period, either seven days or 12 weeks consistent with a lack of pathway reprogramming and tachyphylaxis across all of these studies and continued dependence of inflammatory cytokine production.

On MK too.

Our second analysis consisted of evaluating the impact of ATI 450 on endogenous plasma cytokines in Hs patients.

We carried out this analysis on all 95 patients at time points, where it was confirmed that subjects were dosed along with healthy donor controls evaluating samples a day one pre dose.

In the fourth.

The leasing at trough.

If you turn your attention to slide 20, you can see that endogenous plasma pro inflammatory cytokines and CRP at baseline were lower in the HFC Phase Iia study compared with the <unk> Phase Iia study, which appears consistent with a lower level of systemic inflammation in these hs patients.

The next slide provides a comparison between the <unk> and Hs phase II studies analyzing the impact of ATI 450 on endogenous plasma levels of TNF Alpha IL, six IL eight and Midland data.

While pre dose levels of cytokines will lower in Hs patients compared to <unk> patients in the phase Iia studies are similar persistent decrease in cytokine levels near two or below healthy donor levels was observed in both studies.

Directing your attention to slide 22, you can see the comparison between both studies evaluating the anti inflammatory cytokines IL one receptor antagonist, which is elevated in both HSN RA patients and has not inhibited in either study by ATI 450.

These data demonstrate a pro inflammatory selective modulation of endogenous plasma cytokines and both already in Hs patients.

Lastly, I would like to direct your attention to slide 23, which shows sustained inhibition of.

The plasma acute phase systemic inflammation marker CRP and Hs patients following ATI 450 treatment.

This inhibition of CRP is similar to that observed in the ATI 450 phase Iia <unk> study.

CRP levels are reduced to the upper limit of normal after seven days of dosing and this inhibition was retained through study completion at 12 weeks in both the Hs and <unk> studies.

To summarize on slide 24.

The ATI 450 dependent ex vivo stimulated cytokine inhibition in whole blood demonstrated consistent results across three studies with Mark and sustained inhibition of pro inflammatory cytokines and clear evidence of MK, two dependence and durability of response.

In terms of the endogenous pharmacodynamic plasma biomarker analysis, we saw a subset of cytokines are elevated and Hs blood relative to healthy donors, but to a lesser extent than observed in the <unk> study, which suggests that Hs is perhaps less systemically driven than other diseases such as <unk>.

ATI 450 inhibition trends with pro inflammatory cytokines was similar in both Hs and RA Phase Iia studies, we reducing level near two or below healthy donor levels.

The elevated anti inflammatory cytokines IL, one RA was not modulate by ATI 415, either study suggestive of a pro inflammatory cytokines specific effect.

The acute phase systemic inflammation marker CRP demonstrated persistent inhibition patients administered ATI 450 in both the Hs and RA studies in contrast to the effect previously observed with global P 38 inhibitors.

These data are consistent with ATI 450, demonstrating a similar systemic anti inflammatory effect on both HRS and <unk> patients and we believe correspond to positive efficacy readouts from our completed <unk> trial, however, not hs.

I'll turn it back over to Gail.

Thanks, Jim before I turn the call over to Kevin to touch on our financials I'd like to finish up with the ATI 450 clinical program.

I'm pleased to let you know that we are in the later stages in terms of enrolment for the rheumatoid arthritis phase two b trial and everything is very much on track.

Expect that topline results from the 240 patients international trial in the fourth quarter of this year.

It is also worth noting that we have an independent data safety monitoring committee that meets regularly and to date that committee has not raised any issues related to safety from this trial.

Lastly, touching on the phase Iia Psoriatic arthritis trial.

Since this trial is the last of the 450 trials to get started.

There's also going to be running a bit behind the rheumatoid arthritis and Hs trials.

This study is also heavily dependent on recruitment numerous Polish clinical trial sites.

Based on some of the tensions in the region surrounding Ukraine, It took a little bit longer than anticipated for site. Activations. However, we've recently seen good momentum in screening and enrollment from our published sites.

And as a result, we are adjusting our guidance for top line results of this trial from end of 2023 into the first half of 2024.

This assumes we fully complete the enrollment towards the end of this year.

Overall, despite various hurdles I am very pleased with the professionalism of our development team as well as all of our various partners and trial sites and the commitment of so many physicians and patients.

I look forward to reporting the results to you.

Let me now turn the call over to Kevin to discuss our first quarter results.

Thank you Gail and good morning, everyone.

Our financial highlights our projected on slide 25.

Let us begin with our cash position.

We ended Q1 with cash cash equivalents and marketable securities of $204 million, which was compared to $230 million at yearend.

Additionally, near the end of Q1, we sold three 4 million shares under our ATM facility for aggregate net proceeds of $26 7 million.

This transaction closed in April after the close of the first quarter. So those funds will be recognized as part of our second quarter results.

With the addition of those funds, we believe that our current cash cash equivalents and marketable securities will continue to be sufficient.

And our operations through the end of 2025.

We do like to note that our cash runway protection does not contemplate the costs associated with conducting the phase III development program for ATI 450.

Regarding our financial performance for the quarter, our net loss was $28 2 million for the first quarter of 2023 compared to $18 8 million during the first quarter of 2022.

This difference is primarily driven by the advancement of our ongoing clinical programs.

Total revenue for the quarter was $2 5 million compared to $1 5 million in the prior year's quarter.

This increase was driven by higher licensing revenue primarily from royalties earned on out licensed intellectual property during the first quarter of 2023.

R&D expenses were $22 6 million for the first quarter of this year compared to $14 3 million in the first quarter of 2022.

As previously mentioned this increase has been driven by the advancement of ATI 450, API $17 77.

$21 38.

General and administrative expenses were $8 8 million during Q1 of 2023 versus $6 1 million during the same period in 2022.

This increase was primarily driven due to increased compensation expenses related to increased head count to support our growing development initiatives.

With that I will now turn the call back over to Doug for closing remarks, Doug.

Thanks to you Gael joined Kevin for those comprehensive overview before we ship the call to addressing your questions I'd like to make a few final comments.

I am very pleased with the quality and execution of our entire team here at Claris, we're blessed to have a world class large pharma quality research engine that is very atypical for a biotech company of our size.

The conference team continues to deliver unique and novel potential medicines against targets addressing significant unmet medical needs.

The fruits of that labor include ATI 450, ACI 17, 77, <unk> hundred 21, 38, along with ATI 20 to 31 with more to come.

We're very optimistic about the broad potential of ATI 450, and very eager to complete and report on the current clinical trials.

We took a shot at a very difficult disease and they just knowing that we already had positive already data in hand, we are now laser focused on the completion and timely reporting of results of our ongoing trials in RA and Psoriatic arthritis.

Planning for Phase III studies for those indications and the continued exploration of the MK two mechanism in other indications.

Importantly, we continued to execute on these programs in a fiscally prudent and conservative manner.

It is also gratifying to see that several top tier investors have either taken or increase their positions in our stock recently.

These are very exciting times for clarity in the next several quarters with no exception.

A lot of work in front of us, but we have the right team in place to execute and we look forward to apprise you of our progress as we continue forward.

Operator, we'd now we'd like to open the line for questions.

Thank you.

At this time as a reminder to ask a question you will need to press star one on your telephone.

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The Q&A roster. Please wait for your name to be announced.

One moment for your first question.

And our first question comes from the line of Louise Chen with Cantor. Your line is now open.

Hi, congratulations on all the progress this quarter and thanks for taking my questions.

Wanted to ask you first on the read through from H as tier or a study in a lot of people are anticipating results from that at the end of this year.

And I'm wondering how you think about that elevated level. If you might see that in the <unk> study and then second question I wanted to ask you was on the atopic dermatitis enrollment and did any of that has to do with more drugs being available or really just the winter season, and if you move into a mild.

Their patients how well do you think that drug will do a milder patients and what kind of efficacy have you seen in that patient population and the last question is just on U C.

Did you come to choose this is your first indication and how quickly can you get to proof of concept.

It says this market is rapidly evolving thank you.

Okay.

Luis Doug here so.

Regarding the read through from Hs.

Sorry.

Focusing unica CDK and we see nothing but positive so we have significantly more confidence in the safety profile of the drug and Theres really no red flags.

Develop dozens of drugs.

A real luxury to have one that is looking as this one is obviously we have to complete the program, but so far it's tracking to be an extremely attractive and we think competitive safety profile.

And the drug works systemically exactly as we thought it would NHS and as it did in the early phase Iia. So we're very bullish in terms of what all that means in terms of.

Alright.

It's going to read out in the fourth quarter of this year regarding <unk> I mean, I think Gail did a great job of kind of elaborating what we didn't didn't see in the study, but we just need to just be cognizant elevations with CDK are clinically irrelevant I mean, most people would not even follow these in regular clinical practice, they go up and down based on exercise and an overall level.

Activity the concern would be if there was any associated symptoms with it muscle weakness muscle pain, none of which we saw or if in fact, it looked like it was a cardiac origin and we've looked at.

CK fractionation on many of these patients and Theres been no elevations of CK MB. So so we don't think that we have a CDK issue as we mentioned that there is a data safety monitoring board that is overseeing the <unk> study they have not.

Raised any red flags at all in terms of the prosecution of the study. So I think we're in good shape.

Moving onto the atopic dermatitis enrollment question.

We've been following this space and lots of other companies have experienced the same things that we have it's a little ironic for people who live in the west part of the country because it essentially at a very very snowy winter, but in the areas of the U S that we're doing the phase <unk> study, which is mostly in the northeast and the southeast in fact, it was a very mild winter and we and everybody else we're seeing.

Slowed enrollment, we do think that expanding the enrollment criteria to mild is going to certainly enhance.

The uptick in terms of recruitment and we're confident in terms of the timelines that we issued today.

We don't have data on the phase Iia study was done in moderate to severe atopic dermatitis.

We believe the drug is going to work very effectively in those mild patients and we'll look forward to see the results in the second half of this year.

And then lastly regarding ulcerative colitis.

A very nice deal for Merck and Prometheus.

They have some interesting data in UC, but my experience is.

You don't never kind of throwing the towel just because there are other folks that are kind of hunting in the same in the same area, we think that Mechanistically ATI 2038.

It looks very attractive in the indications that we're seeking UC initially and a whole bunch of other T cell diseases subsequently.

And we'll see how the market evolves, but if you look at the permits this deal in the arena deal with Pfizer Theres, an awful lot of people investing in in IBD, and we think that we're going to be very.

They live in that space.

Okay. Thank you.

Thank you.

One moment for our next question.

And our next question comes from the line of Corinne Jenkins with Goldman Sachs. Your line is now open.

Yes. Good morning, everyone you alluded to this a little bit on the prepared remarks, but could you further contextualize how do you CK elevation compare relative to other oral therapies that are approved and in development for the similar indications, including like the jacks TIK twos and TNF Alphas and then have you thought or received any feedback from kols regarding whats.

Tolerable there.

And then I have a follow up.

Yes, So let me first nice to hear your voice current so.

Gail can you elaborate in terms of the impact of <unk> <unk> of other mechanisms in the in the resi space, but.

The CPA.

Issue collect for a better word in our total Charles has been a bit of a nothing burger for investigators, so dermatologists and Rheumatologists understand.

Asymptomatic CPT elevations are really nothing to worry about.

Have you been asked is why it is that we're measuring them, but it's kind of standard procedure to do so so we've seen we've heard zero concerns from clinicians that this is a clinically significant findings Gail.

Gail do you want to elaborate about the calibrations with other mechanisms sure. So I think one of the things to recognize is well not necessarily covered in the label because it doesn't seem to be a safety concern at all if you look through the literature, particularly TNF and JAK inhibitors, and particularly in rheumatoid arthritis juvenile arthritis.

<unk> and inflammatory bowel disease, but also in skin diseases, you see these what's sort of been benign CK elevation, where the CK seems to be.

Going up as a way of showing muscle regeneration and improvement in.

Muscle bulk in muscle function as you decrease inflammation, there's been some basic science research as well with JAK inhibitors that supports that.

As a differentiation is an important element of what may be going on here.

I think pretty typical of.

What we would expect to see and what we have seen to date with really no evidence of anything pathologic happening.

Thanks, and then you noted but didn't.

Sure.

Valuation of other endogenous cytokines, such as just among others IL 17, IL 12 in 'twenty three and maybe could you just speak qualitatively qualitatively to what you saw there and comment on whether youre seeing an emerging profile with respect to the cytokine knockdowns that can inform future development decisions.

I'll, let Joe take that yes.

Yes, so with the two cytokines that you mentioned.

With IL 17, there was a subset of patients where IL 17 was measurable and was elevated and in those patients.

450 resulted in a reduction in the level of IL 17.

With IL 12.

IL 12 was elevated.

In Hs patients an endogenous and ATI 450 did result in a reduction in IL 12, as well so in both of those cytokines. There was a reduction in measurable levels of those by ATI 400.

Okay, great. Thanks, Thanks for that.

Thanks Brent.

One moment for our next question please.

Yes.

And then the question comes from the line of Tom Smith with SBB Securities. Your line is now open.

Hey, guys. Good morning, Thanks for taking the questions.

I guess first of all on the <unk>.

<unk> study and the CNS adverse events dizziness headache tremor.

Do you have a sense of the etiology really signals and can you clarify if there were any discontinuation due to the CNS events.

Yeah, Hey, Tom Doug here so.

In animal studies at least we do not believe our drug crosses the blood brain barrier, so theres a little bit of a.

The dignitas that there'd be any such symptoms, but I'll, let gail speak on on reputation.

So I'd start by saying that that signal.

Some headaches some dizziness, we've seen also we see we've seen throughout our program we've seen in our phase one unit studies, where patients have very carefully monitoring because they stay in the units for several days or even a few weeks and in those cases it tends to be.

But it's not unusual but also transient.

So in most of the cases.

When they've been looking at this there hasnt been any real rationale for why patients may feel this way.

As Doug already said, we don't have evidence that ATI 450 crosses into the CNS other things that might cause headache, and dizziness like changes in blood pressure has really not been seen in any of our studies, including those where patients were very closely monitoring those phase one unit settings. I think the good news is when patients know that it's going to.

To be something that may occur and is likely to resolve what we found is patients are willing to stay on the treatment.

Okay understood that's helpful and then.

On the <unk> study you provided some color on the discontinuation rate can you just elaborate on that at all and if you can provide an exact number can you maybe characterize it relative to the Hs discontinuation rate is it roughly.

In line or half or a third or like how should we think about that discontinuation rate.

Yes, so we can't elaborate the blinded study, but suffice it to say, we based our power calculations on precedent phase to be in phase III studies, and we're tracking at or below the discontinuation rates that have been seen in competitive study and I would only just add Doug that rate has been very stable over time.

Okay.

Okay, Great got it I appreciate it thanks for taking the questions guys.

Thanks, Tom.

Do you.

One moment for our next question.

And our next question will come from the line of Alex Thomson with Stifel. Your line is now open.

Hey, Thanks for taking my questions.

Just one more quick one on the CK elevation I Wonder if you could sort of comment on where the four treatment emerging adverse events sort of fit in that table on slide 14 in terms of what great CK elevation, whether reserves and then maybe Joe can comment a little bit on PK, and what kind of target coverage youre seeing in this.

Study and the prior space as well and the consistency there. Thanks.

Yes, So let me start so.

It's always been a clinician that ran lots of clinical studies its always strange to me that some people. Some investigators will choose to take off as a clinical adverse event in asymptomatic laboratory adverse event and so we really don't have an explanation as to why those four events, where toggled with such there were elevations of CDK and patients on placebo.

Where it just by luck they happen not to have them be adverse events I'll, let gabe elaborate regarding the magnitude of the of the.

The elevations.

And what I can what I can say is youre obsessed looking at slide 15 in our deck in the graph on the right. You'll notice there we have one CK elevation in gratefully that appeared at baseline and did not occur on treatment at all that was one of our originally reported one that is no longer being <unk>.

Todays treatment emergent adverse event because it was not mentioned and you can see that one which didn't happen on treatment was almost the highest CK elevation that we saw in the study.

The second highest when we saw the study and these were both higher grade elevation is that yellow one and again. This was a a single increase in CK patient had a history of exercise.

And I had no symptoms whatsoever and when it came back on lab. She came back in it was already down and buy the next follow up visit it was entirely down to normal.

This CK elevation that were appointed as adverse events are in that graphic to the right.

Excluding the blueline, which turned out to of course not be treating in merchant.

I think you can see that there is a range there of.

Moderate to higher elevations and then of course interestingly enough. This is one patient in purple with the CK elevation.

On treatment with no hi, Eric in terms of greater toxicity and the CK elevation before treatment. So that was considered sort of a grade zero change.

And to address the question about the <unk>.

<unk> four PK and PD with this study so we have targeted a 50 milligram dose to.

Generate PD inhibition of greater than 80% of <unk>.

And the.

Pharmacokinetics in the Hs study demonstrated that and I think if you look at the.

The data that we had on the ex vivo cytokine production Youre seeing that at day 85 at trough and peak, we're seeing greater than 90% inhibition of.

TNF alpha and greater than 80, some percent inhibition of IL, one beta so I think achieve that.

And just to close I'm happy to take questions.

Now have chronic tox are there through 'twenty six to 39 weeks.

And we didn't see any any muscle toxicity in any of the preclinical toxicology studies have been run to date, we've had zero symptomatic cubic elevations in any humans to date.

And you see the data on slide 15 that visa transient they go away wallet while on drug.

We don't believe that we.

So we'll continue to monitor in the rest of the program of course.

Great. Thanks.

Thank you one moment for our next question. Please.

And our next question comes from the line of Roger song with Jefferies. Your line is now open.

Great. Thanks for taking the question.

And I appreciate all the details for the Hs data, maybe just one quick one I know a lot of question about the CP can just adding one hopefully that's not too much for you.

And.

In terms of the I understand this.

<unk> elevation trends in and kind of a self resolved.

The Medicare you don't have the same tenor associated just curious how long usually takes patients develop anything tenants, while they have some on and off for the CP calibration and how concern we should be if you will.

Taken them longer.

Longer term.

Therapy and that they may have this kind of episodic elevation events. Thank you.

And so today, we only have safety data in humans through week 12 in our in our program. We now with the chronic Tox studies haven't been completed we will be able to dose beyond beyond 12 weeks, but there is nothing in the profile of <unk> that we're seeing to date that would suggest that theres going to be any long term issues with it it would be different if there was smoldering elevations of <unk>.

<unk> K through 12 weeks than you might think that there is something something chronic going on but that isn't the profile that you're seeing at all here. So I think the likelihood is relatively low but of course, let's do the studies and do longer term follow up anything you want to implement the only thing I'd add is measuring CK is not like measuring blood pressure and you know if your blood pressure goes.

And stays at that that can cause harm and of course, we haven't seen any blood pressure changes in our studies that are meaningful of course, but with CK. It's a normal biologic thing it's something that sits in your muscle cells and when you do things day today that may impact your muscles, you get increased turnover of that.

Muscle cells and <unk> can go up and that's not associated with any higher.

Unless theres something underlying going on or something else going on in your body and we have no evidence of that so even transient CK elevation.

Over a long period of time such as these.

Something I would expect to see and you are in me in the course of Hydrogel daily life in any case.

Okay.

Alright, great.

Yes, that's comforting.

Of the saddle came maybe.

Can you just let us know where you are a phase two study.

Anything you can make a comment related to the baseline <unk> consistent with prior art that disease background or have you ever seen those.

Kind of our federal team data yet.

Yes.

So this is a blinded study so we have not looked yet and we wouldn't look anyways.

Until we look at the topline results with Joe anything you want to add about what we're actually going to be looking at in terms of cytokines in the phase <unk> study yeah. So on the phase II B study, we will be looking at endogenous cytokine levels, we won't be doing the ex vivo analysis and that we've already demonstrated in the <unk> study the dependence of these.

Ex vivo cytokines on MK too and the sensitivity of the ATI 450.

Excellent. Thank you.

Thank you. Thank you. Thank you one moment for our next question. Please.

And our next question comes from the line of <unk>.

Hotel with H C. Wainwright your line is now open.

Thank you guys just coming in for a rug Rumsfeld Roger HC Wainwright.

Several questions how do you see the competitive landscape shaping up in a tomo atopic dermatitis and what do you consider to be the key differentiators for ATI $17 77.

It's a great question. Thanks.

The landscape in fact is getting more attractive I think we've all been pleasantly surprised with the successful launch of the insight topical JAK and by the way that topical JAK is basically just the oral JAK that's been applied on the skin. So not surprisingly with it you do see a fairly high level.

Systemic exposure, which I think is why the FDA opted to give them the class labeling with the black box. So the number one area of differentiation that were seeking with our soft topical JAK program is to have similar if not better efficacy to <unk>, but with minimal systemic exposure and thus a significant decrease.

Likely hood of us getting the class labeling we don't know whats going to be in the label until we have the labeling discussions with the U S FDA and there'll be based on finalized phase III data, but just if you look at what we have from our phase Iia study the minimal de minimis exposure seen in patients, which I think is tracking well to the asset profile that we're that we're trying to achieve.

Great and then just switching gears to Psoriatic arthritis.

Might be possible to reaccelerate enrollment in the Psoriatic.

Psoriatic arthritis trial.

Yes.

And just to point out.

It is a difficult part of the world to be doing.

Doing these types of studies, we've seen quite an uptick in enrollment just in the last few months as we've been able to get through.

Inventory hurdles with the Polish government. So I think we are on track to achieve what we set out to do but give anything you want to add in terms of enrollment I would always say that I would like all of our studies, we track them very closely in terms of enrollment and take actions as it makes sense in this particular study.

As I said earlier.

Started this a bit later there was a challenge its in the part of the World with Ukraine, and then with with many many companies switching over to having more studies in Poland, but at this point. The study is going well we're tracking the enrolment we expected we're seeing screening continue to improve.

I think we're on track at present.

We have a high level of investor enthusiasm for it so.

It isn't for a lack of enthusiasm, but there are some headwinds in that part of the world that we're dealing with.

Great. Thank you so much for the color there.

Okay.

Thank you one moment for our next question.

Our next question comes from the line of Julian Harrison with BTG. Your line is now open.

Hi, Good morning. Thank you for taking my questions first on the Hs data while it wasn't the primary endpoint I'm curious if you could comment on what the placebo rates of high score $50 75, and 104 and then on the topical JAK.

$17 77.

Curious if you could talk more about the specific changes to the inclusion criteria, but behind that protocol and then how much would you expect this to affect client characteristics for the overall study population.

Yes, so we're not going into a lot more details regarding the EFT results for Hs suffice it to say that placebo had a very good day on basically every endpoint in fact placebo did better in this study then active did in some of the more successful phase II studies that have already been.

Been published.

Atopic dermatitis is you want to comment on that sure. So on the atopic dermatitis study first I'd start by saying, we carefully look through the literature and where there was available data on response rates in mild patients.

And the feeling was that we did not need to Repower. The study certainly having absolute clinical trial data helped us come to those kind of decisions.

What we did do is we kept the upper range as it was with the mob the moderate and severe but.

That included the Iga class two which is mild in this study. We also dropped body surface area from greater than equal to five to greater than equal to three and easy inclusion. We also track this from greater than or equal to 5% greater than or equal to three.

Cross the board lean, we simply move to including a somewhat milder population as well and as we said screening is going great. There.

Great. Thank you.

Thanks Julien.

Thank you one moment for our next question.

Yes.

Our next question comes from the line of Tim Lugo with William Blair. Your line is now open.

Hey, this is lachlan on for Tim Thanks for taking my questions.

Quick follow up on the enrollment for atopic dermatitis you limiting.

A portion of patients in the trial.

It could fall into that.

Milder.

Cohort.

Maybe just talk about that and then.

Dale on the CCAR elevations, you've mentioned a lot of them seem to be.

<unk> added with exercise so I'm wondering.

Alright.

Bodies.

Are there any.

Sort of limitations or restrictions.

Things like patient exercising before.

And the product yes.

Gail will take both of US sure. So in terms of the new packaging.

In terms of the atopic dermatitis study.

The.

Okay, and what was the question on HIV Davis I don't remind me.

Yes.

Okay.

You limit the number of yes.

Yes, sorry.

Yes in terms of that no not at all the study enrollment study was well enrolled at the point, where we're at we certainly still have room to enroll but we want to make sure we get adequate number of mild patients, we're not giving any kind of stratification for mild moderate or severe.

At this point that my hope would be that we see plenty of matter of mild patients enrolling.

In terms of the <unk>.

CK question.

Sure.

The.

The reality is that if you look at the Hs study. It is a much younger population I mean age is in the mid Thirty's. Most <unk> studies, including <unk> study is anywhere from mid fifties to mid <unk> as a <unk>.

As a mean age also are a as a disease where people are entering with.

Moderate to severe muscular skeletal disease with significant arthritis.

Unusual for it to have quite the same type of problem with people just deciding to go out and do a really intensive exercise regime that said you always want to keep things as real world as possible in these studies and.

CK elevation is likely sign the Hs study with <unk>.

<unk> increases that resolve and treatment are really not indicative and indicative of a concern or reason to restrict anything in the study.

Okay.

Operator any more questions.

Yes.

No that's it for me thanks.

I will turn the call back over to Mr. <unk> for closing remarks.

Alright, there is no further questions I just want to thank everyone again for their time interest and continued support of our company continues to make strides of growth for the future have a great day.

Okay.

Concludes today's conference call. Thank you for your participation you may now disconnect everyone have a wonderful day.

Okay.

Yes.

[music].

Okay.

[music].

Yes.

[music].

Good day, and thank you for standing by and welcome to Clarus Therapeutics first quarter 2023 conference call. At this time all participants are in a listen only mode.

To ask there'll be a question and answer session to ask a question you will need to press star one on your telephone you will then hear an automated message advisor in your hand, it's ways to remove yourself from the queue. Please press star. One again, please be advised that today's conference is being recorded I would now.

Now like to hand, the conference over to your Speaker today, Robert duty Setups Investor Relations. Please go ahead.

Yeah.

Thank you I am Robert duty head of Investor Relations for a class.

Please note that earlier today, we issued a press release, highlighting our first quarter of 2023 financial results and other business matters.

For those of you who have not yet seen it you will find the press release posted under the press releases page of the investors section of our website www of Claris, TX Dot com.

Joining me today for the call are Doug <unk>, our Chief Executive Officer, Gail Cockwell, our Chief Medical Officer, Joe Monahan, Our Chief Scientific Officer, and Kevin <unk>, Our Chief Financial Officer.

Before we begin our prepared remarks, I would like to remind you that various statements. We make during this call about the company's future results of operations and financial position.

Business strategy and plans and objectives for our claris future operations.

Are considered forward looking statements within the meaning of federal Securities laws.

These risks are described in the risk factors section of our Claris with Form 10-K for the year ended December 31, 2022, and other filings of Claris makes with the SEC from time to time.

These documents are available under the SEC filings page of the investors section of our classes website www of Claris, TX Dot com.

Please be advised that today's call is being recorded and webcast.

A link to the webcast can be accessed under the events page of the investors section of our website.

I'll now turn the call over to Doug.

Thanks, Bob and good morning, everyone.

I Hope you had a great weekend. It is my distinct honor to be speaking with you today following not only my first quarter as CEO , but also in the first quarter of operations for our new leadership team.

For those who may be newer to the Cara Therapeutics story, we were originally founded as a specialty pharma company focused on gynecologic conditions.

It was a great credit to my predecessors did a few years ago. The company made the decision to acquire concept life Sciences based in St. Louis.

As evidenced by a number of recent significant transactions in the ini space, including Pfizer's acquisition of Arena Takeda is the acquisition of the Nimbus TIK two program and Merck's acquisition of Prometheus, There is tremendous opportunity for significant creation of shareholder value in this space and we find ourselves in the enviable position of having several key clinic.

So stage assets targeting these potential diseases led by our potential first in class NK two inhibitors <unk> Mehta nib, our ATI 450.

If you could direct your attention to slide three in the slide presentation, we can discuss the agenda for our call today.

We're very pleased to be speaking with you today to provide an overview of our first quarter financial results as well as an update of our timing and plans for the remainder of the year.

I'll begin by providing a few opening remarks on the company's performance to date for the year and then we'll turn the call over to Gail who will provide updates on all of our progress across our clinical development programs.

Following that update Galen, Joe will provide an overview of the final results from the trial in hidradenitis, Suppurativa or Hs for which we reported topline results back in March.

Kevin will then provide an overview of our financial results for the period and finally I'll provide some closing comments prior to opening up the call to address your questions.

Overall I am very pleased with performance of our company through this first quarter of 2023, our team is making tremendous progress advancing all of our various clinical development programs, which is a testament to our team as we are a relatively small company in terms of size and overhead.

I also remain impressed with our team's ability to continue to execute global clinical trials in a challenging macro environment that is continually tact by economic downturn chokes supply chain and global conflicts.

All of these headwinds our team is continuing to prosecute these studies and demonstrating creativity and flexibility in the face of hurdles when they arise and for that I could not be more proud.

During the first quarter of this year, we completed and reported the topline results of our phase Iia trial of ATI 450 NHS.

Although we were disappointed that the <unk> results were not what we had hoped for in this challenging and so relatively misunderstood disease. Our team delivered on time, a well executed trial.

Importantly, this trial further expanded our experience and understanding of ATI 450.

As a reminder, our company already had positive proof of concept data in our rate from our prior phase Iia trial.

Shortly Gail and Joel will be providing more details of the final results of the trial with a focus on how they inform our continued execution of the rest of the ATI 450 program.

With that I'm now going to turn the call over to Gail to begin the discussion on clinical development progress.

Thank you, Doug and good morning, everybody.

Also wanted to take a moment commended claris team on execution as a hydrogen magnitude breakeven Cheyenne.

Also on the tremendous work they've done in recent weeks to fully analyze the results from this study.

That's enabling us to provide you with today is over.

Directing you to slide four the summary of our development pipeline, let's start with our phase one stage clinical asset HCI <unk> and <unk>.

K JAK inhibitor.

Building on the successes of the API 21, 38 senior ascending dose study the multiple ascending dose study in healthy volunteers continues to progress well.

We are very much on track task pharmacokinetic Pharmacodynamic and safety results in the second half of this year.

As we previously announced our first clinical trial of ATI 2138 in a patient population with plan to the phase Iia proof of concept study in ulcerative colitis.

The planning is well underway. So that we can be in position to initiate quickly upon completion of the ongoing multiple ascending dose study.

Later this year, we will provide you with more details on the ulcerative colitis study. After we have the phase one results and is fully finalized the design of this proof of concept study.

Moving on to API 22, 31, our next generation MTT inhibitors, we're moving closer with our prospective epidemic.

Getting to the ultimate objective of setting API 22, 31 in metastatic breast cancer and in pancreatic cancer.

Now shifting to slide six.

For Agi 17, 77, a topical JAK inhibitor, which was designed for skin efficacy and minimize systemic exposure.

We are conducting a phase <unk> study in atopic dermatitis.

A follow up to our successful phase Iia study.

The objectives of the China I'd, just further evaluate the efficacy and safety at ATI 17, 77, and validate the limited systemic exposure.

In the Phase Iia study.

<unk> III development.

We also extended our study population in this study to include children down to age 12, given the importance of this disease in children.

The primary endpoint of the trial is percentage change from baseline in the eczema area and severity index score for easy score at week four.

The target enrollment of 240 patients.

We think it's very encouraged by the success here recently with other capital therapies in a broader array of patients and a meaningful medical need is some milder patients.

As such we recently extended the protocol to include not just moderate and severe atopic dermatitis, but some mild patients as well.

We want to ensure we can enroll adequate mild patients to meaningfully evaluate them.

This protocol modification is also important because as some of you may have seen reported from other companies conducting trials in atopic dermatitis enrollment. This past winter season have encountered some challenges, particularly driven by the mild winter in many locations, particularly in the settlement.

Eastern portions of the U S.

Since the Chinese associated with cold winter weather.

Can exacerbate atopic dermatitis.

And the first few weeks of this protocol amendment, which just went into effect, we have already seen a meaningful increase in screening.

We are updating our guidance in terms of timing of top line results to move from our prior guidance of mid to second half of this year.

And we will tighten up that guidance as we continue to learn more about the impact of the amended protocol.

Moving to slide seven as a reminder, in our phase Iia trial Hei 17, 77 achieved statistically significant results in the primary efficacy endpoint at week four.

And positive trends web sales.

Secondary endpoints, including improvements at X percent of modified easy 50 responders.

Responder analysis and reduction of body surface area impacted by the disease.

Shifting to slide eight importantly, ATI 777 with observed to have a favorable safety and tolerability profile.

And because of the SaaS tactical approach very low plasma levels of Hei 17, 77% was seen following the topical application.

With the average concentrations in patients never greater than 5% as the IC 50 is Jacqueline three and only three patients had concentrations greater than one turn in the ICU.

Now moving on to HCI for 15, we will begin with a more comprehensive overview of the Hs trial now that we have the full dataset.

As you all know from the topline results that we reported in March <unk> did not take either a primary.

Larry or secondary efficacy endpoints in Hs.

As shown on slide 10, we randomize 95 patients into the study with 47, nine placebo and 48 on HCI persists.

Overall, we had 32 patients on the placebo arm complete the study in 2006 on active treatment.

As previously noted the study did not demonstrate efficacy for ATI 450 in the treatment of Hs <unk>.

A modest effect, which was overshadowed by an unusually large placebo.

I do want to spend the majority of our time today on the elements from this trial that can be applied to our understanding at ATI 450 overall.

These elements, primarily fall into two buckets safety and pharmacodynamics.

I will discuss the safety elements in detail and then Joe will discuss the pharmacodynamics.

Slide 11 shows the steady demographics and baseline characteristics.

We are quite proud that we enroll the trial that was very representative of real world Hs patient populations with more inclusion has historically underrepresented people.

From a safety perspective on slide 12, we had no serious adverse events on <unk> 15.

Serious end organ toxicity, and no serious or opportunistic infections.

What we did see unsurprisingly given the lack of efficacy is a meaningful number of early discontinuation from treatment shown on slide 18.

Overall, we had 15 patients in the placebo arm and 28 active arm discontinue from steady treatment.

And we saw high discontinuation starting in the early days of the trial.

And this observation was the primary reason we made the decision to increase the enrollment last fall.

Withdrawals due to loss to follow up with travelers consent and investigator stated lack of efficacy were relatively balanced between the API <unk> and the placebo treated arm.

The divergence in discontinuation with noted fluids trials due to an adverse event with four with strength in the placebo arm hand, and 11 from the API for <unk>.

When we dug deeper however, we noted that the majority of patients in the active arm, who was due to an adverse events seven of the 11, we're not seeing treatment related efficacy.

Theyre, an <unk> with either worse or no better started study.

While most of the adverse events, leading to discontinuation of treatment with only moderate in intensity. It is not surprising that patients who are not seeing a benefit has little incentive to continue treatment.

Further the adverse events that led to discontinuation when most commonly related to worsening Hs.

New coin absence.

Titanium abscess worsening estimate which is closely related to Hs.

We also had a few subjects withdrew due to headache, or dizziness, which is a known phenomenon that occurs in some patients early in the treatment period and typically.

Even when patients continue treatments.

And with further investigator education on this topic, we saw no further discontinuation is for this reason.

And of course, we also provided this education to investigators for the ongoing rheumatoid arthritis psoriatic arthritis trials.

It is important to note pertaining to a correct and let me check arthritis trial, well into an advanced stage of our enrollment process and we are seeing a discontinuation rate in the trial that is quite stable and the low end model projections when we initiated the trial.

Now, let's move on to the other topic that captured the attention from the top line results.

Operations in creatine phosphate kinase or CDK, which is shown on slide 14.

When we issued our press release, we noted that there were 10, 4% or five patients that had reported treatment emergent adverse events.

Elevated slide CK levels.

Subsequent to top line as we finalized our data.

And that one of these patients have elevated teekay prior to receiving study drug.

It was not a treatment emergent events and as such that patient has been removed from that category, which brings the percentage booked down below the 10% threshold that we reported.

Overall, though CK elevation work habit in patients both on ATI 450 and on placebo.

With 19 patients with reported elevations of CK levels and laboratory drivers during some points in the study.

Six of these were on placebo and 13 on ATI 450.

The majority of these were modest elevations. However, as you can see unsteady trials. We also had three grade to <unk> grade three and one grade four CK elevation.

However, moving to slide 15.

And an amazing CK elevation that was great to enterprise when most typically trends in and was typically with change of baseline even when patients continued on treatment.

Many of them were associated with a history of exercise.

More importantly is what the CK elevation, we're not associated with there were no associated adverse events that would suggest something more severe with going on for example, no reported muscle pain.

Mis kidney abnormalities.

Hey, elevations that were not from the skeletal muscles.

We do know that benign CK elevation has been seen with other effective anti inflammatory treatments like TNF inhibitors and JAK inhibitors.

Moving to slide 16 overall to date, we are very pleased with the safety profile, we see with <unk> through the current stage of clinical development.

The adverse event profile has continued to be as expected we.

We have seen transient CK elevation in some patients at generally disappear with continued treatment and you do not have any muscle related symptoms.

We've seen no meaningful effects on kidney or liver or cytopenia is no serious or opportunistic infections.

With that I'd like to turn the call over to Joe to discuss a pharmacokinetic and Pharmacodynamic findings from the Hs study Joe.

Thanks Gail.

Good morning, everyone. Let me start by saying that at the outset, we believe Mechanistically ATI 450 had a chance of demonstrating efficacy in the Hs study.

However, we believe it is likely that the disease is perhaps driven more locally in the skin than through systemic pathways.

I would now like to share what we've learned from the Hs study pharmacokinetic and Pharmacodynamic analysis.

For PD, we took two approaches to understand ATI 450, pharmacodynamics in Hs patient blood as shown on slide 18.

First we conducted an analysis of cytokines and ex vivo stimulated patient blood on a small sample subset of five patients from two sites.

We compared samples from both placebo and ATI 450 treated hs patients with healthy donor controls analyzed in parallel.

We looked at for pro inflammatory cytokines, TNF Alpha IL, one beta IL six and Iot.

After the first dose and then again at the end of the study.

If you direct your attention to slide 19, you can see we provide side by side comparisons across three of the ATI 450 studies completed to date.

The seven day Mad study in volunteers to 12 week already Phase Iia study and the 12 week Hs study.

ATI 450 inhibited all four cytokines analyzed while the data shown focuses on inhibition of TNF Alpha and IL one beta.

On day, one near complete inhibition of these two pro inflammatory cytokines is observed across all three studies, suggesting that their production healthy subjects.

<unk> patients and Hs patients is similarly, dependant on the MK, two pathway and sensitive to ATI 450.

On MK too.

Our second analysis consisted of evaluating the impact of ATI 450 on endogenous plasma cytokines in Hs patients.

We carried out this analysis on all 95 patients at time points, where it was confirmed that subjects were dosed along with healthy donor controls.

Valuation samples that day, one pre dose and in the fourth.

The leasing at trough.

If you turn your attention to slide 20, you can see that endogenous plasma pro inflammatory cytokines and CRP at baseline were lower in the HFC Phase Iia study compared with the already phase Iia study, which appears consistent with a lower level of systemic inflammation in these hs patients.

The next slide provides comparisons between the <unk> and Hs phase II studies analyzing the impact of ATI 450 on endogenous plasma levels of TNF Alpha IL, six IL eight and Nick one data.

While pre dose levels of cytokines will lower in Hs patients compared to <unk> patients in the phase Iia studies are similar persistent decreases cytokine levels near two or below healthy donor levels was observed in both studies.

These data demonstrate a pro inflammatory selective modulation of endogenous plasma cytokines and both already in Hs patients.

Lastly, I would like to direct your attention to slide 23, which shows sustained inhibition.

The plasma acute phase systemic inflammation marker CRP and Hs patients following ATI 450 treatment.

This inhibition of CRP is similar to that observed in the ATI 450 phase Iia <unk> study.

CRP levels were reduced to the upper limit of normal after seven days of dosing and this inhibition was retained through study completion at 12 weeks in both the Hs and <unk> studies.

To summarize on slide 24.

The ATI 450 dependent ex vivo stimulated cytokine inhibition in whole blood demonstrated consistent results across three studies with margin sustained inhibition of pro inflammatory cytokines and clear evidence of MK, two dependence and durability of response.

In terms of the endogenous pharmacodynamic plasma biomarker analysis, we saw a subset of cytokines are elevated in Hs blood relative to healthy donors, but to a lesser extent than observed in the <unk> study, which suggests that Hs is perhaps less systemically driven than other diseases such as <unk>.

ATI 450 inhibition trends with pro inflammatory cytokines was similar in both Hs and re phase Iia studies, we reducing level near two or below healthy donor levels.

The elevated anti inflammatory cytokines IL, one already with not modulate by API for 2015, either study suggestive of a pro inflammatory cytokines specific effect.

I'll turn it back over to Gail.

Thanks, Jim before I turn the call over to Kevin to touch on our financials I'd like to finish up with the ATI 450 clinical program.

I'm pleased to let you know that we are in the later stages in terms of enrolment for the rheumatoid arthritis phase <unk> trial and everything is very much on track.

Expect that topline results from this 240 patients international trial in the fourth quarter of this year.

It is also worth noting that we have an independent data safety monitoring committee that meets regularly and to date that committee has not raised any issues related to safety from this trial.

Lastly, touching on the phase Iia Psoriatic arthritis trial.

Since this trial was the last of the $4 50 trials to get started.

There's also going to be running at <unk>, the rheumatoid arthritis and Hs trials.

This study is also heavily dependent on recruitment numerous Polish clinical trial sites.

And as a result, we are adjusting our guidance for top line results of this trial from end of 2023 into the first half of 2024.

This assumes we fully complete the enrollment towards the end of this year.

Look forward to reporting the results to you.

Let me now turn the call over to Kevin to discuss our first quarter results.

Thank you Gail and good morning, everyone.

Our financial highlights our projected on slide 25.

Let us begin with our cash position.

We ended Q1 with cash cash equivalents and marketable securities of $204 million, which was compared to $230 million at yearend.

Additionally, near the end of Q1, we sold three 4 million shares under our ATM facility for aggregate net proceeds of $26 7 million.

This transaction closed in April after the close of the first quarter. So those funds will be recognized as part of our second quarter results.

With the addition of those funds, we believe that our current cash cash equivalents and marketable securities will continue to be sufficient.

And our operations through the end of 2025.

We do like to note that our cash runway protection does not contemplate the costs associated with conducting the phase III development program for ATI 450.

Regarding our financial performance for the quarter, our net loss was $28 2 million for the first quarter of 2023 compared to $18 8 million during the first quarter of 2022.

This difference is primarily driven by the advancement of our ongoing clinical programs.

Total revenue for the quarter was $2 5 million compared to $1 5 million in the prior year's quarter.

This increase was driven by higher licensing revenue primarily from royalties earned on out licensed intellectual property during the first quarter of 2023.

R&D expenses were $22 6 million for the first quarter of this year compared to $14 3 million in the first quarter of 2022.

As previously mentioned this increase has been driven by the advancement of ATI 450, API $17 77.

$21 38.

General and administrative expenses were $8 8 million during Q1 of 2023 versus $6 1 million during the same period in 2022.

This increase was primarily driven due to increased compensation expenses related to increased head count to support our growing development initiatives.

With that I will now turn the call back over to Doug for closing remarks, Doug.

Thanks to you Gael joined Kevin for those comprehensive overview before we ship the call to addressing your questions I'd like to make a few final comments.

The conference team continues to deliver unique and novel potential medicines against targets addressing significant unmet medical needs.

The fruits of that labor include ATI 450, ACI 17, 77, <unk> hundred 21, 38, along with ATI 20 to 31 with more to come.

We're very optimistic about the broad potential of ATI 450, and very eager to complete and report on the current clinical trials.

We took a shot at a very difficult disease in Hs knowing that we already had positive already data in hand, we're now laser focused on the completion and timely reporting of results of our ongoing trials in RA and Psoriatic arthritis.

Planning for Phase III studies for those indications and the continued exploration of the MK two mechanism in other indications.

Importantly, we continued to execute on these programs in a fiscally prudent and conservative manner.

It is also gratifying to see that several top tier investors have either taken or increase their positions in our stock recently.

These are very exciting times for clarity in the next several quarters with no exception.

A lot of work in front of us, but we have the right team in place to execute and we look forward to apprise you of our progress as we continue forward.

Operator, we'd now like to open the line for questions.

Okay.

Thank you.

At this time as a reminder to ask a question you will need to press star one on your telephone.

To withdraw your question. Please press star one again.

Please standby.

The Q&A roster. Please wait for your name to be announced.

One moment for your first question.

And our first question comes from the line of Louise Chen with Cantor. Your line is now open.

Hi, congratulations on all the progress this quarter and thanks for taking my questions.

I want to ask you first on the read through from H as tier are studying a lot of people are anticipating results from that at the end of this year.

And wondering how you think about that elevated level, if you might see that in the <unk> study and then second question I wanted to ask you was on the atopic dermatitis enrollment and did any of that has to do with more drugs being available or really just the winter season, and if you move into a mild.

Their patients how well do you think that drug will do a milder patients and what kind of efficacy have you seen in that patient population and the last question is just on U C.

Did you come to choose this is your first indication and how quickly can you get to proof of concept.

It says this market is rapidly evolving thank you.

Okay.

Luis Doug here so.

Regarding the read through from a chest.

Sorry.

Focusing Utica CDK, and we see nothing but positive so we have significantly more confidence in the safety profile of the drug and Theres really no red flags.

Developed dozens of drugs.

A real luxury to have one that is looking as this one is obviously we have to complete the program, but so far it's tracking to be an extremely attractive and we think competitive safety profile.

And the drug works systemically exactly as we thought it would NHS and as it did in the early phase Iia. So we're very bullish in terms of what all that means in terms of.

Alright.

It's going to read out in the fourth quarter of this year, regardless of the PK I think Gail did a great job of kind of elaborating what we didn't didn't see in the study, but we just need to just be cognizant elevations of CDK are clinically irrelevant I mean, most people would not even follow these in regular clinical practice, they go up and down based on exercise.

Overall level of activity the concern would be if there was any associated symptoms with it muscle weakness muscle pain, none of which we saw or if in fact, it looked like it was a cardiac origin and we've looked at that.

CK fractionation on many of these patients and Theres been no elevations of <unk>. So we do not think that we have a CDK issue as we mentioned that there is a data safety monitoring board that is overseeing the <unk> study they have not.

Raised any red flags at all in terms of the prosecution of the study. So I think we're in good shape.

Moving onto the atopic dermatitis enrollment question.

We've been following this space and lots of other companies have experienced the same things that we have it's a little ironic or people who live in the west part of the country. Because it has got a very very snowy winter, but in the areas of the U S that we're doing the phase <unk> study, which is mostly in the northeast and the southeast in fact, it was a very mild winter and we and everybody else we're seeing.

Slowed enrollment, we do think that expanding the enrollment criteria to mild is going to certainly enhance.

The uptick in terms of recruitment and we're confident in terms of the timelines that we issued today.

We don't have data on the phase Iia study was done in moderate to severe atopic dermatitis.

We believe the drug is going to work very effectively in those mild patients.

And we'll look forward to see the results in the second half of this year.

And then lastly regarding ulcerative colitis.

A very nice deal for Merck and Prometheus.

I think they have some interesting data in UC, but my experience is.

It will never come to throw in the towel just because there are other folks that are kind of hunting in the same in the same area, we think that Mechanistically ATI 2038.

It looks very attractive in the indications that we're seeking UC initially and a whole bunch of other T cell diseases subsequently.

They live in that space.

Great. Thank you.

Thank you.

One moment for our next question.

And our next question comes from the line of Corinne Jenkins with Goldman Sachs. Your line is now open.

Yes. Good morning, everyone you alluded to this a little bit on the prepared remarks, but could you further contextualize how do you CK elevation compare relative to other oral therapies that are approved and in development for the similar indications, including like the Jack <unk> and TNF Alphas and then have you thought or received any feedback from kols regarding what's.

Tolerable there.

And then I have a follow up.

Yes, So let me first nice to hear your voice current so.

Gail can you elaborate in terms of the impact of <unk> of other mechanisms in the in the <unk> space, but.

The CPA.

Issue collect for a better word in our clinical trials has been a bit of a nothing burger for investigators, so dermatologists and rheumatologists understand.

Asymptomatic CPT elevations are really nothing to worry about.

Have you been asked is why it is that we're measuring them, but it's kind of standard procedure to do so so we're seeing deeper zero concerns from clinicians that this is a clinically significant findings Gail.

Gail joined elaborate about deeply calibrations with other mechanisms sure. So I think one of the things to recognize is well not necessarily covered in the label because it doesn't seem to be a safety concern at all if you look through the literature, particularly TNF and JAK inhibitors, and particularly in rheumatoid arthritis juvenile arthritis.

<unk> and inflammatory bowel disease, but also in skin diseases, you see these what's sort of been benign CK elevation, where the CK seems to be.

Going up as a way of showing muscle regeneration and improvement in.

Muscle bulk in muscle function as you decrease inflammation, there's been some basic science research as well with JAK inhibitors that support that.

It's a differentiation is an important element of what may be going on.

I think pretty typical of.

What we would expect to see and what we have seen to date with really no evidence of anything pathologic happening.

Thanks, and then you noted but.

Sure.

I'll, let Joe take that yes.

Yes, so with the two cytokines that you mentioned.

With IL 17, there was a subset of patients where IL 17 was measurable and was elevated and in those patients.

450 resulted in a reduction in the level of IL 17.

With IL 12.

IL 12 was elevated.

In Hs patients endogenous and ATI 450 did result in a reduction in IL 12, as well so in both of those cytokines. There was a reduction in the measurable levels of those by ATI 400.

Okay, great well, thanks, thanks for that.

Thanks, Greg.

One moment for our next question please.

And then question comes from the line of Tom Smith with SBB Securities. Your line is now open.

Hey, guys. Good morning, Thanks for taking the questions.

I guess first of all on the Hs study and the CNS adverse events dizziness headache tremor.

Do you have a sense of the etiology really signals and can you clarify if there were any discontinuation due to the CNS events.

Yeah, Hey, Tom Doug here so.

In animal studies at least we do not believe our drug crosses the blood brain barrier, so theres a little bit of a.

The dignitas that there'll be any such symptoms, but ill, let gil speak on on reputation.

So I'd start by saying that that that signal.

Some headaches some dizziness, we've seen also we see we've seen throughout our program we've seen in our phase one unit studies, where patients have very carefully monitoring because they stay in the E&S for several days or even a few weeks and in those cases it tends to be.

But not unusual but also transient.

So in most of the cases.

When they've been looking at this there hasnt been any real rationale for why patients may feel this way.

To be something that may occur and is likely to resolve what we found is patients are willing to stay on the treatment.

Okay understood that's helpful and then.

In line or half or like how should we think about that discontinuation rate.

Yes, so we can't elaborate the blinded study, but suffice it to say, we based our power calculations on precedent phase to be in phase III studies, and we're tracking at or below the discontinuation rates that have been seen in competitive studies and I would only just add Doug that rate has been very stable over time.

Yes.

Okay, Great got it I appreciate it thanks for taking the questions guys.

Thanks Al.

Thank you.

One moment for our next question.

And our next question will come from the line of Alex Thomson with Stifel. Your line is now open.

Hey, Thanks for taking my questions.

Just one more quick one on the CK elevation I Wonder if you could sort of comment on where the four treatment emergent adverse events sort of fit in that table on slide 14 in terms of what great CK elevation, whether reserves and then maybe Joe can comment a little bit on PK, and what kind of target coverage youre seeing in this.

Study and the prior space as well and the consistency there. Thanks.

Yes, So let me start so.

It's always been a clinician that ran lots of clinical studies is always strange to me that some people. Some investigators will choose to take off as a clinical adverse event in asymptomatic laboratory adverse event and so we really don't have an explanation as to why those four events, where toggled with touch there were elevations of CDK and patients on placebo.

Where it just by luck they happen not to have them be adverse events I'll, let gail elaborate regarding the magnitude of the.

The elevations.

And what I can what I can say is youre obsessed looking at slide 15 in our deck in the graph on the right. You'll notice there we have one CK elevation in gratefully dedicated at baseline and did not occur on treatment at all that was one of our originally reported one that is no longer being <unk>.

Today, a treatment emergent adverse event because it was that you mentioned and you can see that one which didn't happen on treatment was almost the highest CK elevation that we saw in the study.

The second highest when we saw in the study and these were both higher grade elevation is that yellow one and again. This was a single increase in CK patient had a history of exercise.

And I had no symptoms whatsoever and when it came back on lab. She came back in it was already down and buy the next follow up visit it was entirely down to normal.

This CK elevation that were appointed as adverse events are in that graphic to the right.

Excluding the blueline, which turned out to of course not be treated in merchant.

I think you can see that there is a range there.

Moderate to higher elevations and then of course interestingly enough. This is one patient in purple with the CK elevation.

At on treatment with no hi, Eric in terms of grade of toxicity and the CK elevation before treatment. So that was considered sort of a grade zero change.

And to address the question about the <unk>.

<unk> four PK and PD with this study so we have targeted a 50 milligram dose to.

Generate PD inhibition of greater than 80% of <unk>.

And the.

Pharmacokinetics in the Hs study demonstrated that and I think if you look at the.

The data that we had on the ex vivo cytokine production Youre seeing that at day 85 at trough and peak, we're seeing greater than 90% inhibition of.

TNF alpha and greater than 80, some percent inhibition of IL, one beta so I think achieve that.

And just to close I'm happy to take questions.

Now have chronic tox are there through 'twenty six to 39 weeks.

And we didn't see any any muscle toxicity in any of the preclinical toxicology studies have been run to date, we've had zero symptomatic cubic elevations in any humans to date.

And you see the data on slide 15 that visa transient they go away wallet while on drug.

We don't believe that we will continue to monitor in the rest of the program of course.

Great. Thanks.

Thank you one moment for our next question. Please.

And our next question comes from the line of Roger song with Jefferies. Your line is now open.

Great. Thanks for taking the question.

And I appreciate all the details for the Hs data, maybe just one quick one I know a lot of question about the CP can just adding one hopefully that's not too much for you.

And.

In terms of the I understand this.

<unk> elevation trends in and kind of a self resolved.

And Medicare you don't have the same tenant associated just curious how long usually takes patients develop anything tenants, while they have some on and off for the CP Chem automation and how concern we should be for you.

<unk> taken them longer term <unk>.

And that they may have this kind of a episodic elevation events. Thank you.

And so today, we only have <unk>.

Safety data in humans through week 12 in our in our program, we now with the <unk>.

Ronit Cox studies haven't been completed we'll be able to dose beyond beyond 12 weeks, but there is nothing in the profile of <unk> that we're seeing to date that would suggest that theres going to be any long term issues with it it would be different if there was small during elevations of CPE K through 12 weeks and you might think that there's something something chronic going on but that isn't the profile that you're seeing at all here. So.

The likelihood is relatively low but of course with <unk>.

Let's do the studies and new longer term follow up anything you want to add.

The only thing I'd add is measuring CK is not like measuring blood pressure and you know if your blood pressure goes up and stays up that that can cause harm and of course, we haven't seen any blood pressure changes in our studies that are meaningful of course, but with CK. It's a normal biologic thing, it's something that sits in your muscle cells.

And when you do things day today that may impact your muscles, you get increased turnover of those muscle cells and <unk> can go up and that's not associated with any higher.

Lesser something underlying going on or something else going on in your body and we have no evidence of that so even transient CK elevation.

Over a long period of time such as these.

Something I would expect to see and you are in me in the question, but I don't know daily life in any case.

Alright, great.

Yes, that's comforting.

Of the <unk>.

<unk> maybe.

Can you just let us know where you are a phase two study.

Anything you can make a comment related to the baseline paddle king consistent with prior or that disease background.

Have you ever seen dose.

Kind of our federal team data yet.

Yes.

So this is a blinded study so we have not looked yet and we wouldn't look anyways.

Until we look at the topline results with Joe anything you want to add about what we're actually going to be looking at in terms of cytokines in the phase <unk> study the phase II B study, we will be looking at endogenous cytokine levels, we won't be doing the ex vivo analysis and that we've already demonstrated in the <unk> study the dependence of these.

Ex vivo cytokines on MK too and the sensitivity of the ATI 450.

Excellent. Thank you.

Thank you. Thank you. Thank you one moment for our next question. Please.

And our next question comes from the line of protest.

<unk> Patel with H C. Wainwright your line is now open.

Thank you guys just coming in for a rug Rumsfeld Roger HC Wainwright.

Several questions how do you see the competitive landscape shaping up in a tomo atopic dermatitis and what do you consider to be the key differentiators for ATI $17 77.

It's a great question. Thanks.

Great and then just switching gears to Psoriatic arthritis.

Might be possible to re accelerate enrollment in the psoriatic.

Psoriatic arthritis trial.

Yes.

And just to point out.

It is a difficult part of the world could be doing to be doing these types of studies, we've seen quite an uptick in enrollment just in the last few months as we've been able to get through.

Tori hurdles with the Polish government. So I think we are on track to achieve what we what we set out to do but given the thing you want to add in terms of enrollment for it I can only say that I would like all of our studies, we track them very closely in terms of enrollment and take actions as it makes sense in this particular study.

As I said earlier.

I think we're on track at present, and lastly, we have a high level of enthusiasm for it so.

It isn't for a lack of enthusiasm, but there are some headwinds in that part of the world that we're dealing with.

Great. Thank you so much for the color there.

Thank you one moment for our next question.

Our next question comes from the line of Julian Harrison with BTG. Your line is now open.

$17 77.

If you could talk more about the specific changes to the inclusion criteria, but behind that protocol and then how much would you expect this to affect baseline characteristics for the overall study population.

Atopic dermatitis is you want to comment on that sure. So in the atopic dermatitis study first I'd start by saying.

Carefully look through the literature, and where there was available data on response rates in mild patients.

And the feeling was that we did not need to Repower. The study certainly having absolutely.

Clinical trial data helped us come to those kind of decisions.

What we did do is we.

We kept the upper range as it was with the mob the moderate and severe is but.

Included the Iga class, two which is mild in the study.

Also dropped body surface area from greater than equal to five to greater than equal to three.

Easy inclusion, we also track this from greater than or equal to 5% greater than or equal to three so across the board, we simply move to including a somewhat milder population as well and as we said screening is going great. There.

Great. Thank you.

Thanks Julien.

Thank you one moment for our next question.

Our next question comes from the line of Tim Lugo with William Blair. Your line is now open.

Hey, this is lachlan on for Tim Thanks for taking the questions.

Quick follow up on the enrollment for atopic dermatitis, you limiting the proportion of patients in the trial.

Could fall into that.

So can you milder.

Yes.

Maybe just talk about that and then.

Dale on the CCAR elevations, you've mentioned a lot of them seem to be.

Associated with the exercise so I am wondering.

Alright.

<unk>.

Are there any.

Sort of limitations or restrictions.

Things like patient exercising before.

In the product.

Gail will take both of US sure. So in terms of the pathogen.

In terms of the atopic dermatitis study.

The.

Excuse me what was the question on HIV, David Let me remind me.

Yes.

Okay.

Are you limiting the number of.

Yes, sorry.

At this point my hope would be that we see plenty of matter of mild patients enrolling.

In terms of the <unk>.

Teekay question.

Sure.

The.

The mean age.

<unk> as a disease, where people are entering with.

Moderate to severe muscular skeletal disease with significant arthritis.

CK elevation is likely sign the Hs study with <unk>.

<unk> increases that resolve and treatment are really not indicative of an indicative of a concern or reason to restrict anything in this study.

Okay.

Operator any more questions.

Yes.

No that's it for me thanks.

I will turn the call back over to Mr. <unk> for closing remarks.

Okay.

Concludes today's conference call. Thank you for your participation you may now disconnect everyone have a wonderful day.

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