Immunic Q2 2024 Earnings Report

Immunic EPS Results

• Actual EPS: -$2.10
• Consensus EPS: -$2.30
• Beat/Miss: Beat by +$0.20
• One Year Ago EPS: -$5.40

Immunic Revenue Results

• Actual Revenue: N/A
• Expected Revenue: N/A
• Beat/Miss: N/A
• YoY Revenue Growth: N/A

Immunic Announcement Details

• Quarter: Q2 2024
• Date: 8/8/2024
• Time: Before Market Opens
• Conference Call Date: Thursday, August 8, 2024
• Conference Call Time: 8:00AM ET

Immunic (NASDAQ:IMUX) is a clinical-stage biopharmaceutical company focused on developing novel oral therapies to treat chronic inflammatory and autoimmune diseases as well as certain cancers. The company’s research strategy centers on small-molecule immunology, aiming to offer targeted treatments with improved safety and tolerability profiles. By modulating key signaling pathways within the immune system, Immunic seeks to address underlying disease mechanisms and achieve durable therapeutic benefits for patients.

Immunic’s lead product candidate, vidofludimus calcium (IMU-838), is an oral selective dihydroorotate dehydrogenase (DHODH) inhibitor in Phase 2 clinical development for conditions including ulcerative colitis, Crohn’s disease and relapsing multiple sclerosis. A second program, IMU-935, targets the RORγt pathway, with preclinical and early-stage clinical studies designed to assess its potential in treating psoriasis and other inflammatory disorders. Both programs reflect the company’s commitment to advancing therapies that may offer improved efficacy and convenience compared to existing injections or infusions.

Founded in 2008 and headquartered in New York, Immunic maintains research operations in Germany to leverage its European expertise in medicinal chemistry and translational science. This transatlantic footprint supports robust clinical trial activity and enables collaboration with international academic and clinical partners. Over the years, the company has progressed its pipeline through strategic financing rounds and regulatory engagement, culminating in its NASDAQ listing in early 2020.

Under the leadership of Chief Executive Officer Friederike Bertram, M.D., Immunic continues to expand its pipeline and explore additional indications for its platform of oral immunology agents. Guided by a management team experienced in drug development and regulatory affairs, the company aims to bring new therapeutic options to patients living with immune-mediated diseases and certain oncologic conditions.

Immunic Q2 2024 Earnings Call Transcript

Key Takeaways

• Cash Position and Runway: Ended Q2 with $79.7 M in cash and cash equivalents, which is expected to fund operations into Q3 2025.
• Phase 2 CALIPRE Progress: Top-line data for the progressive MS trial is anticipated in April 2025, targeting non-relapsing secondary progressive MS, an area with no current approved therapies.
• Phase 3 INSURE Milestones: An interim futility analysis is planned for Q4 2024 to inform potential sample size adjustments, with the first and second trial completions expected in mid-2026.
• IMU-856 Advancement: Phase 1b proof-of-concept in celiac disease demonstrated meaningful improvements; Phase 2 planning is underway for celiac disease, ulcerative colitis, or graft-versus-host disease, contingent on funding or partnerships.
• Leadership Enhancements: Strengthened the team by appointing Jason Tardio as COO & President, promoting Werner Gladines to CDO, and adding Simona Skorjanic to the board to support development and commercialization.

Presentation

[Jessica Breu, VP of Investor Relations and Communications at Immunic Therapeutics]

communications at Immunic. I will also be the moderator today. Speaking on the call are Dr. Daniel Vitt, our Chief Executive Officer, Glenn Whaley, our Chief Financial Officer, as well as Jason Tardio, our newly appointed Chief Operating Officer and President. Please note that all participants will be in listen-only mode, and this event is being recorded. After today's 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 of the Zoom portal, or if you would like to speak with us directly, please use the Raise Hand function in the Zoom portal to queue your question. Before we begin, I would like to remind you that this presentation may contain forward-looking statements.

[Jessica Breu, VP of Investor Relations and Communications at Immunic Therapeutics]

Such statements can be identified by words such as may, will, expect, anticipate, estimate, or words with a similar meaning, and such statements involve a number of risks and uncertainties that could cause Immunic's actual results to differ materially from those discussed here. Please note that these forward-looking statements reflect Immunic's opinion only as of the date of this presentation, and it undertakes no obligation to revise or publicly release the result of any revision to these forward-looking statements in light of new information or future events. Please refer to Immunic's SEC filings for a more detailed description of the risk factors that may affect Immunic's results and these forward-looking statements. I would now like to turn the call over to our CEO, Dr. Daniel Vitt, to begin the presentation. Daniel?

[Daniel Vitt, CEO and Director at Immunic Therapeutics]

Thank you, Jessica. I would also like to welcome everybody to today's earnings call. Earlier this morning, we announced our financial results for the second quarter and six months, ended June 30th, 2024. During the call today, we will walk through our second quarter 2024 achievements and subsequent highlights, financial and operating results, as well as our clinical development programs, including 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 second quarter 2024, and subsequent highlights. In April, we hosted a multiple sclerosis R&D Day in San Francisco, highlighting the latest developments in the MS landscape, as well as our development program, vidofludimus calcium.

[Daniel Vitt, CEO and Director at Immunic Therapeutics]

We walked through our highly encouraging preclinical and clinical data generated so far, supporting the neuroprotective potential and reduced disability worsening associated with vidofludimus calcium, which represents unique distinction compared with currently available MS therapies. We also shared our strong belief that vidofludimus calcium could potentially elevate today's standard of care by providing a comprehensive solution for the full spectrum of MS patients, given that it is designed to selectively address all three components of smoldering MS, with its neuroprotective, anti-inflammatory, and antiviral effects, in combination with its favorable safety and tolerability profile. I want to extend our thanks again to everyone who was able to join us for the event, both in person and those who listened to the recordings.

[Daniel Vitt, CEO and Director at Immunic Therapeutics]

Also, in April, we announced that extended data from our phase 2 EMPHASIS trial of vidofludimus calcium in patients with relapsing remitting multiple sclerosis, RRMS, was published in the prestigious peer-reviewed journal, Neurology Neuroimmunology and Neuroinflammation, an official journal of the American Academy of Neurology. The paper, lead authored by Dr. Bob Fox from Cleveland Clinic, who is also the coordinating investigator of our ENSURE and CALIPER programs, included data for both study cohorts with an extended dose range. Inclusion in the publication represents further evidence of the strength of these findings for vidofludimus calcium in RRMS. In May, we had the opportunity to present data from our clinical programs at various scientific conferences.

[Daniel Vitt, CEO and Director at Immunic Therapeutics]

First-in-human data from our phase 1b clinical trial of IMU-856, our orally available and systemically acting small molecule modulator that targets SIRT6 in patients with celiac disease, was presented in an oral presentation at Digestive Disease Week in Washington, D.C. The trial results, gathered during periods of gluten-free diet and gluten challenge, demonstrated meaningful improvements over placebo in four key dimensions of celiac disease pathophysiology, specifically histology, disease symptoms, biomarkers, and nutrient absorption. IMU-856 was also observed to be safe and well-tolerated in this trial. We continue to believe that this data provides initial proof of concept for a potential new oral therapy approach to a range of gastrointestinal disorders through the regeneration of bowel architecture.

[Daniel Vitt, CEO and Director at Immunic Therapeutics]

Additionally, we presented data from our phase II CALIPER trial of vidofludimus calcium in patients with progressive multiple sclerosis, or PMS, at two conferences: the 23rd National Congress of Neurology in Golden Sands, Bulgaria, and Consortium of Multiple Sclerosis Centers 38th Annual Meeting in Nashville. We were pleased to have had the opportunity at both meetings to highlight the clear separation observed in serum neurofilament light chain, NfL, for vidofludimus calcium over placebo in this PMS patient population, as it represents another significant step forward for what could potentially be a first-in-class Nurr1 activator for MS. This strong signal in NfL also makes us believe in a more likely positive outcome of the overall CALIPER trial, as well as clinically relevant endpoints, like prevention of disability worsening.

[Daniel Vitt, CEO and Director at Immunic Therapeutics]

In July, we strengthened our management team with the addition of Jason Tardio in the newly created role of Chief Operating Officer and President. Jason's proven experience in launching and commercializing MS drugs for major biotechnology and pharmaceutical companies will be invaluable, as he will lead internal efforts to prepare for the potential commercialization of vidofludimus calcium. Jason will also work closely with Patrick Walsh, our Chief Business Officer, to prepare the company for a range of potential partnership outcomes for our pipeline assets, where we can leverage his extensive partnering experience. Additionally, Werner Gladdines was promoted to Chief Development Officer. Werner joined Immunic in January 2021, and has held positions of increasing responsibility since then. In his new role, he will take over additional strategic and operational responsibilities for Immunic's overall clinical operational functions.

[Daniel Vitt, CEO and Director at Immunic Therapeutics]

I would like to take a moment to have Jason introduce himself, and to say a few words regarding the recent appointment of Simona Skerjanec as a board member of board of directors, Jason?

[Jason Tardio, COO and President at Immunic Therapeutics]

Thank you so much, Daniel. I'm delighted to be here this morning, and truly excited to have joined the very talented team at Immunic during this pivotal time of the company's growth, as we prepare for a number of important catalyst readouts for vidofludimus calcium over the next six-nine months. Vidofludimus calcium has the potential to address a number of key unmet needs that still exist for the more than two million individuals living with multiple sclerosis worldwide, and I look forward to applying my experiences in launching numerous multiple sclerosis drugs during the course of my career to support Immunic as we begin preparation plans. I was attracted to Immunic because I believe strongly in the potential of vidofludimus calcium, and in the prospect of bringing such a groundbreaking and much-needed oral treatment option to patients with both relapsing and progressive forms of MS.

[Jason Tardio, COO and President at Immunic Therapeutics]

This is a unique medicine with a distinct dual mechanism of action that combines both neuroprotective effects as a first-in-class Nurr1 activator, with additional anti-inflammatory and antiviral effects by selectively inhibiting the enzyme DHODH. The data to date in both relapsing and progressive MS is encouraging, and combined with a favorable safety and tolerability profile, I believe that vidofludimus calcium has the potential to not only meaningfully enhance therapeutic options for individuals living with MS, but to capture significant share in the large global MS market, a market today that accounts for $23 billion in global sales, and is forecasted to grow to $33 billion by the year 2032.

[Jason Tardio, COO and President at Immunic Therapeutics]

In addition to my work on helping to prepare for commercial readiness, I look forward to working closely with our Chief Business Officer, Patrick Walsh, on a range of potential partnership opportunities for both vidofludimus calcium and IMU-856, Immunic's orally available and systemically acting small molecule modulator that targets SIRT6 for celiac disease and other gastrointestinal disorders. As Daniel noted, late last month, we strengthened our board of directors with the appointment of Simona Skerjanec, a thought leader in brain health with decades of experience in drug development and commercialization. Over a nearly 30-year career in the United States and internationally, Simona has led research and development efforts, accumulating in numerous regulatory drug approvals and successful commercial launches, working at companies such as Roche, The Medicines Company, Eli Lilly, Pfizer, and Johnson & Johnson.

[Jason Tardio, COO and President at Immunic Therapeutics]

It is worth pointing out that Simona led business and global corporate strategy for Roche's portfolio of neurological and rare diseases, achieving sustainable double-digit growth in sales, including with Ocrevus, or ocrelizumab, which remains one of the most successful medicines for the treatment of MS. I will now turn the call back over to Daniel.

[Daniel Vitt, CEO and Director at Immunic Therapeutics]

Yeah, thank you, Jason. We are very proud and excited that both you and Simona joined the Immunic team. Simona's track record in drug development and commercialization, combined with Jason's experience in launching and commercializing MS drugs, really strengthens Immunic as we work towards the potential commercial launch of vidofludimus calcium in MS. That concludes our summary of the second quarter 2024, and most recent highlights. We remain pleased with the clinical and operational advancements we are making across our programs. As it relates to our lead asset, vidofludimus calcium, we are advancing both our phase 2 CALIPER trial in patients with progressive MS, and our twin phase 3 ENSURE trials with relapsing MS. Based on the strong clinical evidence to date, we continue to pursue partnering discussions with both global and regional pharmaceutical companies.

[Daniel Vitt, CEO and Director at Immunic Therapeutics]

Our team has also been busy advancing our IMU-856 program, which has the potential to become a game changer for the treatment of a broad range of GI disorders. As mentioned in our previous calls already, we are currently exploring different options to further fund phase II clinical development of IMU-856 in celiac disease, and potentially other GI indications. I would now like to turn the call over to Glenn to provide financial overview. Glenn?

[Glenn Whaley, CFO at Immunic Therapeutics]

... Thank you, Daniel. I will now review the financial and operating results for the second quarter and six months ended June 30, 2024. Let me start with a review of our cash position. We ended the second quarter of 2024 with $79.7 million in cash and cash equivalents, which we expect to be able to fund our operations into the third quarter of 2025. Regarding the operating results, R&D expenses were $18.3 million for the three months ended June 30, 2024, as compared to $21.2 million for the three months ended June 30, 2023. The decrease was mainly driven by reductions in clinical development costs for the IMU-856 and IMU-935 programs. This is partially offset by an increase in external development costs related to the vidofludimus calcium program.

[Glenn Whaley, CFO at Immunic Therapeutics]

For the six months ended June 30, 2024, R&D expenses were $37 million, as compared to $44.1 million for the six months ended June 30, 2023. The decrease was mainly driven by reductions in clinical development costs for the IMU-856 and IMU-935 programs, which was partially offset by an increase in personnel expenses. G&A expenses were $4.5 million for the three months ended June 30, 2024, as compared to $3.8 million for the same period ended June 30, 2023. The increase was primarily related to personnel and legal and consultancy expenses. For the six months ended June 30, 2024, G&A expenses were $9.6 million, as compared to $8.1 million for the same period ended June 30, 2023. The increase was primarily related to personnel, legal, and consultancy expenses.

[Glenn Whaley, CFO at Immunic Therapeutics]

Interest income remained unchanged at $1 million for the three months ended June 30, 2024, as compared to the three months ended June 30, 2023. For the six months ended June 30, 2024, interest income was $2.2 million, as compared to $1.8 million for the same period ended June 30, 2023. The $400,000 increase was due to higher interest rates. We also reported a change in fair value of the tranche rights for the six months ended June 30, 2024. The change of $4.8 million was a non-cash charge related to the change in the value of the tranche rights associated with the future tranches 2 and 3 of the January 2024 private placement.

[Glenn Whaley, CFO at Immunic Therapeutics]

Other income was $0.4 million for the three months ended June 30th, 2024, as compared to $0.1 million for the same period ended June 30th, 2023. The increase was primarily attributable to an increase in foreign exchange gains, which was partially offset by a decrease in other grants received and a decrease in R&D tax incentives for clinical trials in Australia as a result of less spend for clinical trials in that country. For the six months ended June 30th, 2024, other income expense was -$1.7 million, as compared to $1.2 million for the same period ended June 30th, 2023.

[Glenn Whaley, CFO at Immunic Therapeutics]

The decrease was primarily attributable to a $1.7 million expense related to a portion of costs from the January 2024 financing related to the tranche rights that were established at the time of the closing of Tranche One in the timing of recognizing the German Federal Ministry of Finance grant, as well as a decrease in R&D tax incentives for clinical trials in Australia as a result of less spend for clinical trials in that country. The decrease was partially offset by an increase in foreign exchange gains.

[Glenn Whaley, CFO at Immunic Therapeutics]

The net loss for the three months ended June 30, 2024, was approximately $21.4 million, or $0.21 per basic and diluted share, based on 101.3 million weighted average common shares outstanding, compared to a net loss of approximately $24 million, or $0.54 per basic and diluted share, based on approximately 44.4 million weighted average common shares outstanding for the same period ended June 30, 2023.

[Glenn Whaley, CFO at Immunic Therapeutics]

Net loss for the six months ended June 30, 2024, is approximately $51 million, or $0.51 per basic and diluted share, based on approximately 99.6 million weighted average common shares outstanding, compared to a net loss of approximately $49.3 million, or $1.12 per basic and diluted share, based on 44 million weighted average common shares outstanding for the same period ended June 30, 2023. With that, I will turn the call back over to Daniel for a review of our development pipeline and upcoming milestones. Daniel?

[Daniel Vitt, CEO and Director at Immunic Therapeutics]

Yeah, thank you, Glenn. I would now like to provide an update on our clinical development programs and anticipated upcoming milestones. We eagerly anticipate reporting top-line data from our Phase II CALIPER trial of vidofludimus calcium in progressive MS in April of next year. If the top-line data continues to show neuroprotective effects, we may be able to position the drug as the first oral treatment option for non-relapsing secondary progressive MS, the progressive MS subtype with the highest unmet medical need and currently no approved therapeutics available for patients. Additionally, we expect to report an interim futility analysis of our phase III ENSURE program in the fourth quarter of this year, after approximately half of the events have occurred in the double-blind treatment periods. This analysis will allow for a non-binding futility analysis and inform potential sample size adjustments.

[Daniel Vitt, CEO and Director at Immunic Therapeutics]

We further expect to complete the first of our identical twin phase III ENSURE trials in relapsing MS in the second quarter of 2026, and the second ENSURE trial in the second half of 2026. We plan to provide detailed insights on our MS development program at our next MS R&D Day, which we will host in New York City on September 10th. We plan to discuss the unique profile of vidofludimus calcium and its potential to become a groundbreaking treatment of choice for both RMS and PMS patients. As I noted earlier in this call, we believe that vidofludimus calcium could meaningfully improve today's standard of care by providing a holistic solution for the full range of MS patients.

[Daniel Vitt, CEO and Director at Immunic Therapeutics]

The event will also feature two top-notch industry experts: Dr. Francesca Montarolo from University Hospital Turin in Italy, who is one of the leading experts for the Nurr1 target protein, as well as Dr. Amit Bar-Or from University of Pennsylvania, who is one of the leading neuroimmunologists and well-known MS expert. We very much look forward to having such excellent speakers at our MS R&D Day. As it relates to our second clinical stage asset, IMU-856, we remain very enthusiastic about this program and believe that its innovative mode of action is uniquely suited to treat a broad range of serious gastrointestinal disorders, such as celiac disease, inflammatory bowel disease, or graft versus host disease. By targeting the physiological intestinal epithelial regeneration, we believe IMU-856 treatment results in gut wall healing and the absence of broad immunosuppression.

[Daniel Vitt, CEO and Director at Immunic Therapeutics]

It bears repeating that data from our phase Ib clinical proof of concept trial of IMU-856 in patients with celiac disease during periods of gluten-free diet and gluten challenge demonstrated significant improvements over placebo in four key dimensions of clinical outcomes in celiac disease: protection of gut architecture, improvement of patient symptoms, enhancement of nutrient absorption, and strong biomarker response. As previously reported, we have begun preparing for phase II clinical testing of IMU-856, and in addition to celiac disease, we are also exploring a number of other clinical applications for other gastrointestinal disorders, where the renewal of the gut wall is important, contingent on further financing, licensing, or partnering of the asset. This brings us to the end of our formal presentation. Jessica, please open the call for a Q&A session.

[Jessica Breu, VP of Investor Relations and Communications at Immunic Therapeutics]

Yeah, thank you, Daniel, and also Glenn and Jason, for walking us through the second quarter and subsequent highlights, as well as our clinical development pipeline. We will now begin the question and answer session. As a reminder, 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 of the Zoom portal, or if you would like to speak with us directly, please use the Raise Hand function of the Zoom portal to queue your question. Our first guest today is Yasmeen Rahimi from Piper Sandler. Yas, please unmute yourself and go ahead.

[Yasmeen Rahimi, Managing Director and Senior Research Analyst at Piper Sandler]

Good morning, team. Thank you so much for all the great updates. A few questions for you. I guess, one of the questions is, when you designed the, your current phase III studies, ENSURE studies, was there always a futility built in? Is that, is that standard protocol for MS studies? If you could talk about that. And, and also kind of dissect out what are the possible-- what is the likelihood that there will need to be a sample size adjustment? So would love for you to sort of tackle that, and then I have a follow-up in regards to CALIPER.

[Daniel Vitt, CEO and Director at Immunic Therapeutics]

Yeah. Thank you, Yasmeen. And very clearly, yes, it was from the very beginning, the futility was built into that study. One of the main reasons is it's an event-driven study-

[Yasmeen Rahimi, Managing Director and Senior Research Analyst at Piper Sandler]

Mm-hmm.

[Daniel Vitt, CEO and Director at Immunic Therapeutics]

and we just wanted to make sure that not for just random things, we run short on a couple of patients. And as you know, with futility analysis, you need to predefine the questions, and therefore, we have only a limited small number of-

[Yasmeen Rahimi, Managing Director and Senior Research Analyst at Piper Sandler]

Mm-hmm

[Daniel Vitt, CEO and Director at Immunic Therapeutics]

... sample size adjustment options, where-

[Yasmeen Rahimi, Managing Director and Senior Research Analyst at Piper Sandler]

Mm

[Daniel Vitt, CEO and Director at Immunic Therapeutics]

... the committee can say yes or no. So, it's a very straight and important thing, and

[Yasmeen Rahimi, Managing Director and Senior Research Analyst at Piper Sandler]

Mm-hmm

[Daniel Vitt, CEO and Director at Immunic Therapeutics]

... I think it really makes just ensures that the money of those phase III studies is really well invested, and we succeed in the overall program.

[Yasmeen Rahimi, Managing Director and Senior Research Analyst at Piper Sandler]

Okay. Thank you. And then in regards to CALIPER, obviously, you know, the primary endpoint is looking at the brain volume change. I think in the past you have talked about sort of a 15% change would be sort of reflective. I would love for you to kind of go back as we go into April, what do you hope to see in analyzed volume rate? And also, some of the key secondaries, right? Like, what are ones that we should be able to maybe pick up statistical differences, maybe a reminder of what are considered clinically meaningful differences? Obviously, you guys are measuring nicely a number of key secondaries from the EDSS scores to the 25-foot walk tests, et cetera. So would love for you to kind of talk about that as well, and then I'll jump back into the queue.

[Daniel Vitt, CEO and Director at Immunic Therapeutics]

Yeah, I'm very happy that you asked the question because I think CALIPER is really could be a major transformative study for MS patients and also for the company. And as you said, the primary endpoint of the study is brain volume change between placebo and the 45 milligram active dose. But as you said, I think there are secondary endpoints, which are medically also very meaningful. And you mentioned the EDSS change, so confirmed disability worsening so that the official secondary, key secondary endpoint is 24-week confirmed disability worsening, which we'll also report in April. And on top of that, there are other parameters which could help us to understand to what extent vidofludimus calcium has neuroprotective effects, and part of that are, as you mentioned, cognitive functions.

[Daniel Vitt, CEO and Director at Immunic Therapeutics]

We have the nine-hole peg test, we have the 25-foot walk test, and these standard things implemented in the study, and we also will report on those. All of those are meaningful, I think. The study was really designed to give a full picture. We have randomized 467 patients overall in the study. It's a big study, and we have high expectations of what we can see here. What I can't tell you and others right now is what is the exact threshold of activity here? I mean, as you mentioned, a 15% benefit on disability protection would be something medically relevant, I think, but there is no official number what is here meaningful-

[Yasmeen Rahimi, Managing Director and Senior Research Analyst at Piper Sandler]

Mm-hmm

[Daniel Vitt, CEO and Director at Immunic Therapeutics]

... and what not. But in the absence of any treatment, for example, for non-relapsing secondary progressive, every step forward would be perceived as a, as a success, I think.

[Yasmeen Rahimi, Managing Director and Senior Research Analyst at Piper Sandler]

Got it. Thank you so much.

[Daniel Vitt, CEO and Director at Immunic Therapeutics]

Yeah, thank you, Yasmeen.

[Jessica Breu, VP of Investor Relations and Communications at Immunic Therapeutics]

Thank you, Yasmeen. Next one in the queue here is Matt Kaplan from Ladenburg Thalmann. Matt, please unmute yourself, and welcome to the call.

[Matt Kaplan, Managing Director and Head of Healthcare Equity Research at Ladenburg Thalmann & Co]

Hi, good morning, guys, and thanks for taking the questions. This is just a follow-up to Yasmin's question on CALIPER. Just give us a sense in terms of why the interim NfL changes that you observed in the study make you confident or give you confidence in the outcome of the study that we'll see in April?

[Daniel Vitt, CEO and Director at Immunic Therapeutics]

Yeah, thank you, and good morning, Matt. That's a very good question because we, we spent a lot of work on really understanding the role and the relevance of NfL for predicting disability outcome. And I think the most of the, the, the hints why that is believed to be relevant is coming from the newer literature of other studies. I think one of the most important, or maybe the most important in that context, was a very good paper published last year, with the main author, Amit Bar-Or, as I said, who will join us for the MS R&D Day in September, and he was the main author of the paper on ocrelizumab study, the ORATORIO study in primary progressive MS.

[Daniel Vitt, CEO and Director at Immunic Therapeutics]

And they clearly have shown that if you really focus on those patients which don't show relapses and don't show inflammation, and they did it by rebaselining the study population, then a lower NfL level at baseline is predictive of future disability outcome, of a lower rate of disability worsening for the patients at low NfL. So that's why. It's a pretty big data set, and I think it was really nice that they have shown that there is this correlation, which was statistically significant. There are other hints from non-interventional studies, interventional studies, where also this relation was shown. But the point is that we think that NfL is a very good tool, but we need to be very careful on really separating inflammatory from non-inflammatory patients at the evaluation.

[Daniel Vitt, CEO and Director at Immunic Therapeutics]

Therefore, looking back on the interim data we reported last October for CALIPER, with a statistically significant 22% reduction of NFL compared with the active plus between active and placebo, we think that makes us very optimistic on a readout on the disability protection in next April after the full 120-week data.

[Matt Kaplan, Managing Director and Head of Healthcare Equity Research at Ladenburg Thalmann & Co]

Thanks, Daniel. That's very helpful.

[Daniel Vitt, CEO and Director at Immunic Therapeutics]

Yeah. Thank you, Matt.

[Jessica Breu, VP of Investor Relations and Communications at Immunic Therapeutics]

Thank you, Matt. Next one in the queue here is Tom Smith from Leerink Partners. Tom, please unmute yourself, and welcome.

[Tom Smith, Senior Research Analyst at Leerink Partners]

Hey, guys. Good morning.

[Jessica Breu, VP of Investor Relations and Communications at Immunic Therapeutics]

Good morning.

[Tom Smith, Senior Research Analyst at Leerink Partners]

Thanks for taking the questions. Just one on vidofludimus. I mean, you mentioned you continue to explore partnership and other business development opportunities. Can you just elaborate on the level of engagement with pharma now, I guess how that's evolved over the last 12 months, and what you're looking for in a potential partner?

[Daniel Vitt, CEO and Director at Immunic Therapeutics]

Yeah, happy... Maybe Jason, would you like to take over?

[Jason Tardio, COO and President at Immunic Therapeutics]

Sure

[Daniel Vitt, CEO and Director at Immunic Therapeutics]

... that question?

[Jason Tardio, COO and President at Immunic Therapeutics]

Sure. So look, when we think about partnerships, clearly, you know, our goal is, if this medicine is successful, would be to ensure that we can get it to as many patients as quickly as possible, right? And therefore, you know, not only help patients that continue to have unmet need, but also to increase you know, value for the company and for shareholders. And so we're exploring a variety of different potential partnerships that is not limited to, you know, just full out-licensing. It could be regional out-licensing. It could be partnerships around profit share and others. Again, we're building expertise in-house, as Daniel has mentioned. It's a big reason why I've joined the company.

[Jason Tardio, COO and President at Immunic Therapeutics]

We believe that if necessary and if needed, we will go forward ourselves and begin to build commercial plans to launch these drugs ourselves. But, you know, we have a responsibility as well to look at partnerships, and so we are in active discussions with a variety of different companies. I obviously will not mention specifics at this time for both, you know, large global, but also regional potential partnerships, and we look forward to sharing additional information in the future.

[Tom Smith, Senior Research Analyst at Leerink Partners]

... Got it. That makes sense. And then just one on, on eight five six. Yeah, I was just wondering if you could provide a little bit more color on where you stand with the, phase two plans. Have you engaged with or received feedback from the FDA? And then, I guess what are the gating factors to starting the, celiac study?

[Daniel Vitt, CEO and Director at Immunic Therapeutics]

Yeah, I think as I, as I said, the focus of the company is really right now to ensure the full performance and speed of the MS programs. Therefore, we are looking for independent additional financing for 856 programs, and we want to do that in a hopefully broad way to not just bet on one indication, but also hopefully being able to do more than one clinical application here. And the three options we have on the table, and we are working on in the preparation of protocols, discussing with experts, exploring potential sites and so forth, that's actively ongoing. So these are, of course, celiac disease as the indication where we have already received very good proof of concept data, but also in ulcerative colitis and as a third indication, which is interesting.

[Daniel Vitt, CEO and Director at Immunic Therapeutics]

Specifically, it's a smaller niche indication, but the mode of action perfectly fits there: graft versus host disease. So these are the three things we are looking at. In that context, we have some regulatory discussions, and we think we have a clear plan forward. Currently, most work is done in discussions with investors and potential partners to make sure we have the right design and the right concept together to go the next big steps into phase II studies.

[Tom Smith, Senior Research Analyst at Leerink Partners]

Got it. That makes sense. Thanks for taking the questions.

[Daniel Vitt, CEO and Director at Immunic Therapeutics]

Yeah, thank you, Tom.

[Jessica Breu, VP of Investor Relations and Communications at Immunic Therapeutics]

Thank you, Tom. Once again, if you have a question, please use the raise hand function of the Zoom portal or the Q&A tool, and I see some more here in the queue. I would like to welcome next, Tyler Bussian from Brookline. Tyler, please unmute yourself and go ahead.

[Tyler Bussian, Biotechnology Research Analyst at Brookline Capital Markets]

Hi, Jessica and Daniel. Thanks for taking the time. Quick question on the potential data readouts from CALIPER. Obviously, since you designed the trial, you had a large amount of data talking about the neuroprotective effects and kind of secondary mechanisms compared to traditional DHODH inhibition. I just kind of wanted to get a sense of if a lot of those neuroprotective readouts come through, are there any possibilities for, you know, expedited review, fast track designation from the FDA? What, I guess, kind of is that a possibility, and what type of results would you need to see for something like that?

[Daniel Vitt, CEO and Director at Immunic Therapeutics]

Yeah, thank you for the question, Tyler. Of course, that depends on the data. That's the answer you always get with, for such questions, but I think you're right. Given the absence of real treatments for non-relapsing secondary progressive, and also considering that 60% of the 467 patients in the study have a non-relapsing secondary progressive MS, this is an area of huge unmet need, and I think also the regulators are aware of this around the world. So if the data is good, and good means showing a relevant, medically meaningful protective effect, for example, on disability worsening, on brain volume change, and maybe also other cognitive parameters, we of course will try to discuss with the regulators to what extent we are able to expedite the track towards approval.

[Daniel Vitt, CEO and Director at Immunic Therapeutics]

That could... In a positive case, it could really be a very much quicker way to get the drug to the patients, and I think it's something we'd really be happy to do.

[Tyler Bussian, Biotechnology Research Analyst at Brookline Capital Markets]

Great. Thank you for your time.

[Jessica Breu, VP of Investor Relations and Communications at Immunic Therapeutics]

Thank you, Tyler.

[Daniel Vitt, CEO and Director at Immunic Therapeutics]

Thank you.

[Jessica Breu, VP of Investor Relations and Communications at Immunic Therapeutics]

Next one here is Madison El Saadi from B. Riley. Madison, good morning. Please unmute yourself.

[Madison El-Saadi, Healthcare Equity Research Analyst at B. Riley Securities]

Hey, guys.

[Madison El-Saadi, Healthcare Equity Research Analyst at B. Riley Securities]

[audio distortion].

[Jessica Breu, VP of Investor Relations and Communications at Immunic Therapeutics]

Oh, good morning. We can hear you, but we have a feedback.

[Madison El-Saadi, Healthcare Equity Research Analyst at B. Riley Securities]

Yeah, I think, I think it's fixed now. Thanks-

[Jessica Breu, VP of Investor Relations and Communications at Immunic Therapeutics]

Oh, yeah, that's better. Thank you.

[Madison El-Saadi, Healthcare Equity Research Analyst at B. Riley Securities]

Thanks for taking our question. So, a couple from me, kind of starting with my left. So given the missteps we've seen with the BTK class, I'm just kind of wondering your expectations for this class. Do you think we've already seen the ceiling of efficacy and kind of the floor of safety for this class? And maybe if there's a scenario where you become... you're able to kind of leapfrog this drug class and become the oral therapy of choice.

[Daniel Vitt, CEO and Director at Immunic Therapeutics]

Yeah, I think, of course, the ibrutinib data was a disappointment for the patients, and we all need to admit that the industry tried really a lot to develop that class of BTK inhibitors as a next option for RMS and PMS. And there, I think there's still some in development, and I think the market is expecting data, for example, from Sanofi soon, on their tolebrutinib data. I think already my perception is that the ibrutinib data really opened doors for us because they more or less, it's recognized that there is a good alternative and an interesting molecule with a new mode of action, first-in-class Nurr1 activator, which could fill into here, potentially, lower number of other alternative development candidates in the BTK pipeline.

[Daniel Vitt, CEO and Director at Immunic Therapeutics]

So yeah, we clearly think that we see already that the market has that impression. But it's still open, I think, despite the clinical holds in the U.S. for some of the BTK inhibitors, they are still in development, and we will see what's coming out of the studies there.

[Madison El-Saadi, Healthcare Equity Research Analyst at B. Riley Securities]

... Okay, great. Thank you. And then secondly, so assuming the Phase II CALIPER is positive, is it too early to talk about next steps, if you'll go straight to kind of Phase III? And if so, you know, would that be in a PPMS or active or non-active SPMS population, or are you thinking, you know, kind of a wider population, targeting all of PMS?

[Daniel Vitt, CEO and Director at Immunic Therapeutics]

Yeah, sure we're doing that. I think this is our duty. We need to think about it. We already. The clinical team is working on a protocol for phase III in PMS. And regardless if we get expedited approval or not, the phase III will be needed. We know that one phase III should be sufficient for progressive MS. And also, clearly the focus is likely, and also looking on the interim data, the focus will likely be first on non-relapsing secondary progressive MS, given absence of any other treatments there. That makes it medically the quickest and the high-demand indication, and therefore. And the drug seems to work in this difficult-to-treat population, at least based on the biomarker side. So yeah, I think that's the way forward from our point of view.

[Daniel Vitt, CEO and Director at Immunic Therapeutics]

However, as Jason said, this is also need also be seen in the, in the global strategy. It could be a piece of a global partnership. So there are other ways. Let's look at the data. We're doing the homework, we are prepared for different options, but I think the most important piece is to get the data and to see, how strong are they and what options do we have on the table then in the, in the second quarter of next year.

[Madison El-Saadi, Healthcare Equity Research Analyst at B. Riley Securities]

Got it. Thank you.

[Daniel Vitt, CEO and Director at Immunic Therapeutics]

Thank you.

[Jessica Breu, VP of Investor Relations and Communications at Immunic Therapeutics]

Great. Thank you, Madison. All right, this concludes our question and answer session today. I would like to turn the conference back over to Daniel for any closing remarks.

[Daniel Vitt, CEO and Director at Immunic Therapeutics]

Thank you, Jessica, and thanks to all of today's attendees for your always insightful questions. I would like to end the call by reiterating how excited we are about the potential of our advanced clinical pipeline programs. With top-line data from our phase II CALIPER trial expected in April of next year, and the ongoing enrollment of our phase III ENSURE trials, we continue to make tangible progress with our lead program, vidofludimus calcium. Importantly, with $79.7 million balance sheet, which is expected to fund the company into the third quarter of next year, we are capitalized even a couple of months beyond the CALIPER readout.

[Daniel Vitt, CEO and Director at Immunic Therapeutics]

Additionally, as progress is made and contingent on financing, licensing, or partnering, we expect to also provide an update on our preparations for a phase II clinical trial of IMU-856, and its unique potential for the treatment of a broad array of serious gastrointestinal disorders. With that, I would like to close today's call. Thank you again for joining, and we are very happy to answer any additional questions one by one, so please do not hesitate to reach out.

[Jessica Breu, VP of Investor Relations and Communications at Immunic Therapeutics]

Thank you for joining Immunic second quarter 2024 earnings call. The call has now concluded. You may now disconnect.

Participants

Executives

• Daniel Vitt, CEO and Director
• Glenn Whaley, CFO
• Jason Tardio, COO and President
• Jessica Breu, VP of Investor Relations and Communications

Analysts

• Madison El-Saadi, Healthcare Equity Research Analyst at B. Riley Securities
• Matt Kaplan, Managing Director and Head of Healthcare Equity Research at Ladenburg Thalmann & Co
• Tom Smith, Senior Research Analyst at Leerink Partners
• Tyler Bussian, Biotechnology Research Analyst at Brookline Capital Markets
• Yasmeen Rahimi, Managing Director and Senior Research Analyst at Piper Sandler