Q3 2023 Immunic Inc Earnings Call

My name is Jessica <unk> head of Investor Relations and communications at the Munich I will also be the moderator on today's call speaking on the call are Dr. Daniel <unk>, Our Chief Executive Officer, and President as well as Glenn Whelan, Our Chief Financial Officer. Please note that all participants where they end up not only mode and this event is being recorded.

After todays presentation, there will be an opportunity to ask questions. If you joined the webcast via the zoom platform. There are two ways to submit questions. You can either submit your questions in writing via the Q&A tool up to student portal or if you would like to speak with US directly please use the red and functions and assume quota carrying a question.

Before we begin I would like to remind you that this presentation may contain forward looking statements such statements can be identified by words, such as May will expect anticipate estimate or.

With a similar meaning and such statements involve a number of risks and uncertainties that could cause immune <unk> actual results to differ materially from those discussed here. Please note that these forward looking statements reflect immunity opinions only as of the date of this presentation and it undertakes no obligation to revise or publicly release the results of any revision.

These forward looking statements in light of new information or future events. Please refer to immune <unk> SEC filings for a more detailed description of the risk factors that may affect the music's resides and peaceful but looking statements.

I would now like to turn the call over to our CEO and president of <unk> to begin the presentation Daniel.

Thank you Jessica.

I would also like to welcome everybody to todays earnings call.

Earlier this morning, we announced our financial results for the third quarter ended September 32023.

Our press release and Form 10-Q.

During the call today, we will walk through our third quarter 2023, and subsequent highlights financial and operating results as well as anticipated upcoming milestones.

As Jessica noted after the presentation, you will have the opportunity to ask questions.

Let's start with a review of our third quarter 2023, and subsequent payments.

I would like to begin with our video <unk> costume development program in multiple sclerosis.

August we completed enrollment of our phase II clinical trial, our video feed them was killed in patients with progressive multiple sclerosis or PFS.

A total of 460000 adult patients with primary <unk>.

S.

Our active or not active secondary PFS were randomized to either 45 milligram daily doses of either produce calcium or placebo.

Patients were enrolled at more than 70 sites in North America restaurant in central and Eastern Europe.

A few months later in October we reported overwhelmingly positive interim data from this phase III clinical trial in total 230 patients were included in this analysis.

The overall population, which includes all subtypes of Pms saw a 22, 4% improvement in zero for the midlife Chan of Nf L for Nf L. For me just with the most calcium over placebo at week 24.

We believe that this is a substantial and meaningful difference in favor of beta for the Ms calcium and this pms population.

A statistically significant difference was found for serum NFL at week 24 between beautiful Moscow, two and placebo with a P value of zero consider one.

If you look at our.

If you look at the sub class a progressive illness to the right. You can appreciate that this difference in NFL at week 24 was consistently strong throughout all subtypes of progressive illness.

I would like to point out that we saw a 20% reduction for video produce calcium versus placebo and S. P. M S, meaning the patients with no focal inflammation activities, but.

Disease progression. This subtype of it's a difficult to treat population with no relevant FDA approved therapies.

This slide puts our caliper interim data into the perspective of historical third party studies and the same progressive from that sometimes on the left we display the data off of P. P. M S.

To the oratorio study for kind of come up with which showed a spread of MF element is between active and placebo at 24 weeks of 12, 4%.

And the kind of a trial, we observed an 18, 8% improvement of active drug overdose Evo in P. P. M S at week 24.

The results of this phase III study led to approval.

Zoom up for treatment of prepayments.

And the Central Slide you see historical data for secondary progressive Ms. Both for non actors and actresses Pms and comparison, we just want them as accounts team was able to show a substantial reduction of Nf L and both the active and inactive populations to our knowledge. This is the first time that such a substantial factor.

Nf L has been shown in non <unk> patients.

Which is the pms subtype with the highest unmet medical need.

The right side of the slide shows comparison between our fish to emphasis data provider for those calcium in RMS versus our historical relapsing Ms Studies.

To complete the picture.

In summary, we believe the clear separation observed for a chairman for me to figure was calcium over placebo and this pms patient population.

Represents another major step forward for what potentially could be a first in class no one activator for emmis.

The strong signal also points to more likely positive outcome of the overall caliber trial also in clinical relevant data points like prevention of disability worsening.

In October Dr. Robert J Fox from Cleveland Clinic, who is also the coordinating investigator of our insured and chemical programs presented data.

From our phase II emphasis.

Buffy diplomas counts in our RMS and the E poster at the joined actors actresses meeting.

As a reminder, beautifully Ms calcium showed an improvement in serum Nf L. In both treatment arms of 30, and 45 milligrams or placebo.

Just recently, we received a notice of allowance from the U S. PTO for patent covering the treatment of relapsing Ms with a specific dose strengths beautiful muscocho.

This includes a daily dose of about 10 milligrams to 45, because your Grandma Pwm's Chaucer and other source as well as the free acid form altra.

<unk> treatment for Lipstick M. S also covering the 30 milligram dosage used in our ongoing two phase III trials.

The claims are expected to provide protection into 2041 and best expenditure.

This patent significantly both to be multilayered proprietary IP position, we have built around our late stage program for patients with Ms.

Moving to <unk> 856 programs.

In July we hosted a virtual celiac disease expert on table to discuss ongoing active celiac disease R. O ACD is serious lifelong autoimmune disorder.

The substantial unmet need for therapeutic solutions.

We were grateful and honored to have been joined by this event by the renowned thought leaders from Harvard Medical School.

You can see the actresses foundation.

During their own tissue, our chief Medical Officer. Andreas also provided an overview of IBM <unk> six program, including our positive phase one trial results in celiac disease patients released earlier SKU in me.

Which I will highlight again in just a moment.

Also in October we presented two abstracts at the United European Gastroenterology week.

<unk> W 2023, Michael.

My colleague Dr. Francisco embryonic senior medical director and Munich presented data from our positive phase one clinical trial of <unk>.

Six in patients with celiac disease during a moderated poster session.

And your 806 is an orally available and just technically acting small molecule modulator of the targets or at six.

China results gathered during periods of gluten free diet and clips and challenge demonstrated positive effects for I'm really trying to fix over placebo in four key dimension of celiac disease pathophysiology protect.

Protection of the gut architecture improvement of patient symptoms biomarker response and enhancement of nutrient absorption.

I'm an ex US six was also observed to be safe and well tolerated in this trial.

We believe that this highly encouraging data provides initial clinical proof of concept for an entirely new therapeutic approach to gastrointestinal disorders, but promoting the regeneration of the whole architecture.

Additionally, Dr <unk> from Amsterdam University Medical Center.

Presented data from our phase II tells us one trial, particularly Ms calcium in ulcerative colitis or UC.

As a reminder, the maintenance phase results from the Carlos one trial demonstrated statistically significant activity offer diplomacy calcium compared to placebo.

And reaffirm the drugs favorable safety and Tolerability profile.

The data validated the potential of diplomacy calcium in your seat and other inflammatory bowel disease indications.

Earlier this month <unk> had another opportunity to percentage of data from our phase one clinical trial of <unk> in patients with celiac disease and the virtual E poster at the association of European Celiac Societies General Assembly Conference in Athens, Greece.

That concludes our summary for the third quarter 'twenty towards history and subsequent highlights.

Very happy at the scientific and clinical advancement and progress made across our different programs has been extremely positive during this year.

<unk> is leveraging this momentum now in discussions with pharmaceutical companies for IH six our goal is to identify a partner was capable of performing several therapeutic phase two clinical trials for either for the most counts through the release of a very good biomarker NFL data that's been an important trigger point for partnering discussions with global and retail.

Okay.

I would now like to hand over the call to.

To Glenn to provide financial overview.

Glen.

Thank you Daniel I will now review the financial and operating results for the third quarter ended September 32023.

Let me start our review of our cash position. We ended the quarter was $59 7 million in cash and cash equivalents.

With these funds, we expect to be able to fund operations into September of 2024.

Regarding the operating results.

R&D expenses were $19 8 million for the three months ended September 32023, as compared to $16 5 million for the three months ended September 30 of 2022.

These costs were mainly driven by external development costs related to the ongoing clinical trials, a beautiful unless calcium and personnel expenses.

This was partially offset by a decrease in external development cost related to the <unk> 93, 5% EMEA 856 programs.

The night.