Q2 2023 Quoin Pharmaceuticals Ltd Earnings Call

Good morning.

Welcome to coin Pharmaceuticals limited second quarter physical.

Salt and business update conference call.

All participants will be and listen only mode.

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Today's presentation, there will begin opportunity to ask questions to ask a question you May Press Star then one on your telephone keypad to withdraw your question. Please press Star then too. Please note. This event is being recorded I would now like to turn the conference over to Gordon done.

C F L.

Go ahead.

Thank you and good morning.

Joining us in two days.

What's it called.

Are you going to call a doctor local diners C E O N Denise Carter.

We used to provide an update on our progress for the second quarter.

As well as discussing are two 220 23 financial results. Please.

Please note that our operational and financial results press releases now available and coins website.

It keeps you more than a normal procedure.

Michael.

Clinical and operational update following what would you.

So.

Well done hadn't called up to Michael Some closing comments there'll also be pleased to answer any questions at the end of the call.

Before we begin I'd like to remind everyone that statements made during this conference call them.

Eating at the private security litigation before or after the 1995, which is all risks and uncertainties.

Ask the results.

And the information expressed or implied by these forward looking.

Statements.

For more information regarding such risks and uncertainties, what do you see the risk factors.

The company's filings with the F C C.

Any forward looking statements are made only goes up today and we describe any obligations update you scored a few statements other than as required by law.

Please see the forward looking statements financial.

This morning for more information.

None of my pleasure to turn the call over to our C E O.

Likewise Michael.

Thank you and good morning, everyone.

On our last call I reported on the very strong start calling has had 220 23 today.

Today I'm very pleased to announce this morning.

Some card into.

The second quarter.

May 24th we announced that are open label [laughter].

Syndrome clinical trial had achieved 50 per cent were coupland.

Additional subjects have been enrolled since Scott.

I recall that we only dose the first subject in this study in March of this year. So we are very pleased with the pace of recruitment overall.

Our other than African syndrome clinical study is on track to have recruited majority of subjects. This month.

Is extremely encouraging how high the interest level continues to be our participation in both studies.

Today, the availability of data.

Patients to complete our open labor clinical study and I will provide more commentary on this later in the call.

Also during the quarter, we make substantial progress.

It is to initiate additional lesson her syndrome clinical studies.

Kooning, one and a pre identified cohort of approximately 2010 patients in the middle East.

Wireless and X U S study in pediatric subjects.

We believe these additional clinical trials with supplement.

The data package that is currently being generated by our ongoing studies here in the U S.

Either leading company in this space, we are fully committed to generating comparing body of clinical evidence to support global regulatory approval for cure X as you ever two or three.

Safe and effective treatment for NASA considerable.

During the quarter. We also continued to engage actively with Queensland University of technology I'll kill you T in Australia.

All he has to ongoing research programs.

Q U T. One for flower Dharma and the other hurting after 10 syndrome.

The active ingredient in the lack of cold weather gear perfect mechanism of action to our own cure X 003, and we believe this product potentially is complementary features to cure extra Jersey directory.

That's crazy outside why both of these programs are still at an early stage of development. We continue to believe that they are Parker crew corners of our product portfolio and we look forward to their advancement input clinical testing.

Both research programs are being conducted in Australia.

Coin is amber could take advantage of a 43.5 per cent tax rebate from the Australian government as well as a more rapidly than I. That's my opinion too human clinical testing tennis hospital here in the U S are in Europe .

Also during the quarter, we made kinds of those progress on our plans to initiate clinical testing of pure rack 003.

An additional indications beyond nethercutt syndrome.

[noise] vacationers into peeling skin syndrome.

See I'm syndrome, I'm, Pamela Panther correct that there are none.

None of which there are any approved pretty much fall, we'd hold to provide further updates on our progress in the near future, including timing of initiation a proof of concept clinical testing and patients.

During our last call I also updated everyone on our M.

M. A next Saturday.

Discuss given our strong bother street.

Potential access to additional cockatoo, we are acutely focused on expanding our product portfolio via acquisition licensing or other means.

We are primarily interested in late stage outfits and the rare and often cause he's space that are underpinned by strong clinical data.

Highly favorable commercial opportunities based on readily identifiable competitive strength.

While there can be no guarantees that kind of action would it be consummated I can tell you that a number of discussions continued to advance.

African plea throughout the quarter, we are optimistic that coin with enter into at least one such a transaction by the end of the year, we look forward to keeping you updated.

Progress during this very exciting time for coin.

Also on our last call I know, who that another company had filed at 90 with the F D. A.

And received a study may proceed ladder to initiate the clinical development of their product as a protective treatment for <unk> syndrome.

This morning father in the overview of the clinical trials Dot Gov website. It appears that this study has not yet been initiated at coin remains the only pharmaceutical company could be actively conducting clinical studies unnecessarily syndrome.

And openness.

[noise] vacation, a new drug application.

R I N D.

We need a global commercial partners continued to be exercises by the extent of the commercial opportunity got up painting. The first regulatory approval for a treatment for this disease represents.

Turning now to our ongoing clinical studies in syndrome patients today.

We had the privilege of announcing the availability of clinical data from the far subject to complete testing and open the neighbors Scott.

I'm very pleased to be able to tell you that this day that is hard to tape across all measured and.

You may recall that in this open label study.

Subjects are currently receiving off labor systemic treatment and will continue to do so in conjunction with cure at 003 40 duration of the study.

It is worth noting that all subjects in the study have been treated with all flavor systemic therapy for at least one year and then the number of cases there multiple years.

Notwithstanding this ongoing longtime systemic therapy treatment all patients with Crusade into this study.

Straight to your symptom of Medicine syndrome.

Including compromise scale and pool rises R H.

As a result of this longtime systemic therapy subjects were crusade into the study.

Not for a baseline for us to assess if treatment with cure at 003 over a duration of 12 weeks would lead to any therapeutic.

Improvement across a number of assess clinical egg.

And so it was for the first subject who conclusive testing in this study.

Despite the longtime systemic therapy.

Subject exhibited classic symptoms of an African syndrome on entry into this study. However, I'm very pleased to say on completion of this study for this subject cure.

There are three Cleveland area.

Speak fully clear.

Both side of clinical investigator as well as by a widely recognized visuals scoring system.

Furthermore, the subject also expressed a very favorable impression of cure.

There are three o'clock, a number of important metrics.

And cartoons and you also on completion of this study.

That's cool, alright, which I secure.

Two or three Cleveland area was deemed to be negligible.

Her mind or one of the primary reasons for people with Naprosyn syndrome, Tiguan systemic therapy as far as symptomatic relief from their correct yes.

So does this particular subject despite haven't been honest with stomach therapy for well over a year. It was only after 12 weeks of treatment with cure like 003.

Their prices have decreased Jordan diabetes adult level.

Although this data represents.

An important milestone for coin.

The first clinical evidence of the potential efficacy of cure that cause the jurors zero three and that's in the city room I do want to strongly caution that it is from the patient only.

Care should be taken not to read too much into this state.

Other patients in this study reached the same point.

To provide additional updates in due course.

As mentioned earlier are ongoing double blind study is now on track to have a majority of subjects recruiters, they're smart we are.

Frequently asked if the open labor study cannibalizing subjects from the double Blind study and I can tell you.

This is not the case at all both studies are recruiting independently of each other and feedback from the community is that the availability of two such distinct clinical call options.

Patience effects ability to enroll in a study that is best suited to their own ongoing treatment regimen.

I also want to highlight in that that in both studies to date and across all subjects tested you are at 003.

Australia and exemplary safety profile.

Given the highly compromised skin.

Patients have.

This is very encouraging news.

Florida bolsters, our confidence in the potential cure at 003 to become the forest products.

To safely and effectively treat this disease.

Without.

Our operational progress, let me turn it over to Gordon now to discuss our second quarter financial results.

Thank you Michael.

As of June 30, or cash and marketable securities was approximately fortunately $15.4 million compared to $17 million as of March 31.

Which we continue to expect will be sufficient to fund our operations in debate 2024.

Or not lost for the second quarter was 2.1 million compared to 2.7 billion for the second quarter of 2022.

Decrease was primarily due to exceptionally high legal and professional speeds in the second quarter and 22.

Oh now I'll turn the call back to Michael to make some closing remarks beginner Q&A Mike.

Michael.

[noise]. Thank garden today marks an important milestone for coin.

Hold for nurses and patients syndrome.

That's a syndrome patients everywhere, we are extremely excited to announce the results of the very first clinical data.

Sure extra zero, three and that's S N patients.

[noise] outlined we strongly caution and I do want to emphasize this point.

The data is just from a single subject only and may not be representative of findings from additional subjects.

Right.

That being said the positive nature of the data across all measure clinical endpoints, it's certainly encouraging with both of our studies continuing to recruit subjects. We look forward to releasing additional data in due course.

We remain.

Italy focused on pursuing M&A activities and are targeting executing at least one such transaction by year end.

We've got operator, we are now ready for questions.

We will now begin the question and answer session.

To ask a question you May press Star then one on your telephone keypad. If you were using a speaker phone. Please pick up your handset before pressing the keys.

To withdraw your question. Please pass Star then too at this time, we will pause momentarily to assemble our roster.

The first question comes from Nos Ramen with Maxim Group. Please go ahead.

Hi, everyone. Congratulations on the date on the progress I'm Gonna talk a little more about the dead. He saw from the single patient I'm just gonna start on can you talk a little more about the onset the Kansas and I get the timing of the benefits did you like see most of the benefits early in the trial.

Or did you see more of the benefits towards the end of the trial and what is the timing of the different benefits for eye gets improvements on a different point consistent.

For the different appointment or did your friend pinpoint sort of reach.

I guess like positive static or.

A part of the result at different time points.

Good morning, Thanks for the call and thanks as always for participating so really good questions.

The benefits really star kids to become evident far this particular subject in the second half of this study. So as you know with the 12 weight dosing period. So it was really from six weeks on now we're not assessing the patient every week. So it it's hard.

To pinpoint exactly when but certainly it was in the in the second half of this study and the timing of onset of benefit was consistent across all he had point so she'll watch the benefits start to the kicking it became.

Evident across each of the four and points that were being measured.

[laughter] Gotcha sounds awful I know, it's only been so long since you evaluated that first patient but.

The patient has been off therapy, you guys conduct like a follow up and hesitation seen any recurrence of symptoms or have you found durability.

So.

That's information that I I don't have now.

The latest study was set up is that the patient was.

Enrolled in the study freeze it for 12 weeks.

And then you know they're they're gone so there there really isn't follow up now we are looking to see.

If we we can continue to treat patients farther he you know in an extended open label part of this study, but I I don't have any information as to what the current situation with that with that patient is I I I I will tell you though.

The product cure like 003 is a competitive searing protease inhibitor. So once you discontinue treatment with it then you know if targets the collar crimes and the skiing are responsible for a lot of the the issues of patients suffer from once you've just continued treatment.

Collar crimes go back to being out of control. So I was strongly suspect that's the the treatment areas of the patient have now.

Reverse back to the the previous message syndrome symptoms that they that they had an entry into the study.

Got it and my last question is somewhat of a two parter. Once again acknowledging this is data from a single patient has these findings someone impacted your thinking on how you might refiner. Just later studies and also Sir.

<unk> 10 syndrome.

Is really like a full body disease are you considering potentially.

Having larger application or more application areas for later studies.

Yeah. These are really good questions and you know [noise].

We we started this we went into completely uncharted territory nobody had ever been there before and you know neither Austin or the F. D. A had any precedents. So our thinking is starting to laws now as data starts to be generated first of all it and importantly, we were not seen.

Any safety signals. So so that's that's really good news. So that allows us to think you know holistically should we increase the dose should we may be looked cheap dose twice a day. So so these are discussions about where Halloween because now we feel like these options come into play and wished.

Regards to full body dosing that is something that we are talking about it mentions a potential study in the middle East.

On pre identified nurses and patients and that's something that we're considering for for that particular study and I don't feel like we we will deviate too far from what we have agreed with the F. D. A for U S. A U S approval, but certainly for these other stuff.

Is there there's a lot more scope to eat or increase the dose increase the frequency and increase the surface area that's been tested.

Once again, congratulations on the data and looking forward to your future read outs.

That's bad.

The next question.

Again, if you have a question. Please press Star then one and the next question is from Jim Malloy Alliance Global Partners. Please go ahead.

Hello. This is Laura <unk>. Thank you for taking my questions. So what's the enrollment for both suck Your X 003, child's moving along what's the potential tiny here for top line data and you know subsequent basically program as well.

[noise] so [noise].

We certainly will have a top line data from the open label study by the end of the year.

And believe for the double blind this study.

Really.

Early in next year. So we were continuing to target you know regulatory approval.

In the early part of 2025. So you know we we we are in a position to move pretty quickly here and as you know the number of patients stuff. We need for approval is quite limited. So I I I think those targets were Maine.

Got it and then also you mention the 20 patient study to be conducted in the middle East. So just what are some of the other updates you have on the potential expansion of you know cure accident, Oh, sorry outside the U S and maybe some other time lines here as well.

Yeah. So you know I I think we we have established eight commercial partnerships outside of the U S. Now span 60 countries. So our our focus here is not a U S. In Europe . We are looking at this as it is.

Rover opportunity.

So.

The data that we're starting to general right now from these ongoing studies could be used by some of our partners to.

Obtain approval earlier in their respective jurisdictions done say in the U S and Europe and also allow for entry into compassionate use our early access programs. So the generation of data now starts to open up a lot of opportunities for us and as we.

We continue to assess and you know how do we build.

Strongest possible database farthest product you know we were looking at these these additional studies. So so we're taking a very broad based milk at this we're in very close communication with our commercial partners watered what are their needs to obtain approval.

In their countries. So a lot of a lot of behind the scenes discussions happening Laura and stay tuned we will have further updates.

Got it thank you for taking the questions and congratulations on the private system. This corner.

This concludes our question and answer session I would like to turn the conference back over to Michael Myers for any closing remarks.

Thank you just to say appreciate everybody's turning up this morning, and as always if you have any further questions.

Or need any additional information please feel free to reach out to us that we remain a readily accessible so have a great day and thank you very much.

The conference has now concluded. Thank you for attending today's presentation you may now disconnect.