Q2 2024 Immunic Inc Earnings Call

August 8, 2024

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Jessica Breu: Good morning and welcome to Munich's second quarter 2024 earnings call. My name is Jessica Breu, Vice President of Investor Relations and Communications at Munich. 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.

Unknown Executive: Good morning, and welcome to Munich's second quarter 2020 for earnings calls.

Jessica Brew: Good morning, and welcome to <unk> second quarter 2020, Q4 earnings call. My name is Jessica Brew, Vice President of Investor Relations and communications at Communing I will also be the moderator today.

Jessica Breu: My name is Jessica Breu, Vice President of Investor Relations and Communications at Munich. I will also be the moderator today.

Jessica Breu: Speaking on the call, our Dr. Daniel Vitt, our Chief Executive Officer, Glenn Whaley, our Chief Financial Officer, as well as Jason Tardio, are newly appointed Chief Operating Officer and President.

Operator: 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.

Speaker Change: Speaking on the call our Doctor Danielson, our Chief Executive Officer, Glenn Wailea, our Chief Financial Officer, as well as Jason Cardio, our newly appointed Chief operating Officer and President.

Jessica Breu: Please note that all participants will be listened-only mode, and this event is being recorded. After today's presentation, there will be an opportunity to ask questions. If you join the webcast via the Zoom platform, there are two ways to submit questions.

Speaker Change: Please note that all participants will be in listen only mode and this event is being recorded.

Jessica Breu: 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 questions.

Speaker Change: 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 two of the same product or if you would like to speak with US directly. Please use the right hand function and assumed portal to Twilio question.

Unknown Executive: Good morning and welcome to Munich's second quarter, 2020 for earnings calls.

Jessica Breu: You can either submit your questions and writing via the Q&A tool of the Zoom portal, or if you would like to speak with us directly, please use the raised hand function in the Zoom portal to cure your question.

Jessica Breu: My name is Jessica Breu, Vice President of Investor Relations and Communications at Immunic. I will also be the moderator today. Speaking on the call, our 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.

Jessica Breu: 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 words with a similar meaning. And such statements involve a number of risks and uncertainties that could cause Immunics' actual results to differ materially from those discussed here. Please note that these forward-looking statements reflect Immunics' 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.

Speaker Change: 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 words with similar meaning and such statements involve a number of risks and uncertainties that could cause <unk> actual results to differ materially.

Jessica Breu: Please note that all participants will be listened only most and this event is being recorded. After today's presentation, there will be an opportunity to ask questions. If you join the webcast via the Zoom platform, there are two ways to submit questions. You can either submit your questions and writing via the Q&A tool of the Zoom portal, or if you would like to speak without directly, please use the raised hand function in the Zoom portal to cure your question.

Speaker Change: From those discussed here.

Jessica Breu: Please note that these forward-looking statements reflect, in Munich's opinions only, as a state of this presentation, and it undertakes no obligation to revise or publicly release the results of any revision to these forward-looking statements in light of new information or future events. Please refer to Munich's SEC filing for a more detailed description of the risk factors that may affect Munich's results and these forward-looking statements.

Speaker Change: Please note that these forward looking statements reflect in Unix opinion, only as of the date of this presentation and it undertakes no obligation to revise or publicly release the results of any revision to these forward looking statements in light of new information or future aliens.

Jessica Breu: 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 words with a similar meaning. And such statements involves 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 opinions only as a state of this presentation and it undertakes no obligation to revise or publicly release the results of any revision to these forward-looking statements in light of new information of future events.

Jessica Breu: Please refer to Immunics' SEC filings for a more detailed description of the risk factors that may affect Immunics 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.

Speaker Change: Please refer to <unk> SEC filings for a more detailed description of the risk factors that may affect in Unix results in these forward looking statements.

Speaker Change: I would now like to turn the call over to our CEO, Dr fit and fit to begin the presentation Daniel.

Daniel Vitt: Thank you, Jessica. I would also like to welcome everybody to today's earnings. Earlier this morning, we announced our financial results for the second quarter and six months ended June 30th, 2020. 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 high.

Speaker Change: Thank you Jessica I would also like to welcome everybody to todays earnings call.

Daniel Vitt: Earlier this morning, we announced our financial results for the second quarter in six months and June 30th, 2024. During the call today, we will walk through our second quarter 2020 for achievements and subsequent highlights, financial and operating results, as well as our clinical development programs, including anticipated upcoming milestones. As Jessica noted, out of the presentation, you will have the opportunity to ask questions.

Speaker Change: Earlier this morning, we announced our financial results for the second quarter and six months ended June 32024.

Daniel Vitt: 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 master's. Also in April, we announced that extended data from our Phase II Emphasis Trial of Pedophilimus calcium in patients with relapsing-remitting multiple sclerosis, or RMS, was published in the prestigious peer-reviewed journal Neuroimmunology and Neuroinflammation, an official journal of the American Academy of Neurology.

Speaker Change: During the call today, we will walk through our second quarter 'twenty 'twenty four achievements.

Jessica Breu: Please refer to Immunic's SEC filing for a more detailed description of the risk factors that may affect Immunic's results and these forward-looking statements.

Speaker Change: Subsequent finance financial and operating results, the Suez or clinical development programs, including anticipated upcoming milestones.

Daniel Vitt: I would now like to turn the call over to our CEO, Dr. Dennis Fitz, to begin the presentation, Daniel. 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 in six months and June 30th, 2024. During the call today, we will walk through our second quarter 2020 for achievements and subsequent highlights, financial and operating results, as well as our clinical development programs, including anticipated upcoming milestones.

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

Daniel Vitt: Let's start with a review of our second quarter 2024 and subsequent highlights. In April, we hosted a multiple sclerosis on GD in San Francisco, highlighting the latest developments in the MS landscape, as well as our development program, MediaFlimus calcium. We walked through our high and encouraging proclamical and clinical data generated so far, supporting the neuroprotected potential and reduced disability worsening associated with facial miscalculation, which represents a unique distinction compared with currently available MS therapies. We also shared our strong belief that MediaFlimus 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 small-during MS, with its neuroprotective, anti-inflammatory, and anti-barrel effects.

Speaker Change: Let's start with a review of our second quarter 'twenty 'twenty four and subsequent highlights.

Daniel Vitt: In April, we hosted Multiple Sclerosis IG Day in San Francisco, highlighting the latest developments in the MS landscape, as well as our development program, Media Phlegma Scars. We went through our highly encouraging preclinical and clinical data generated so far, supporting the neuroprotective potential and reduced disability worsening associated with reduced ruminous calcium, which represents a unique distinction compared with currently available MS therapy. We also share our strong belief that metamphetamus 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 recording.

Speaker Change: In April we hosted a microdose girls as Archie today in San Francisco, highlighting the latest developments in the Investor escape as well as our development program recently, Wisconsin.

Speaker Change: Walked through our highly encouraging preclinical and clinical data generated so soares supporting to neuroprotective potential and reduced disability worsening associated with recent Wisconsin, which represent a unique distinction compared with currently available therapies.

Daniel Vitt: As Jessica noted, out of 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 on GD in San Francisco, highlighting the latest developments in the MS landscape, as well as our development program media flumeous calcium. We walked through our high and encouraging proclamical and clinical data generated so far, supporting the neuroprotective potential and reduced disability worsening associated with facial miscalcium, which represents a unique distinction compared with currently available MS therapies.

Speaker Change: We also shared our strong belief that redeployment calcium could potentially elevate the 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 M S with its nerve protectors anti.

Speaker Change: Batori and antiviral with things in combination with its favorable safety and Tolerability profile.

Daniel Vitt: In combination with its favourable safety and tolerability proof.

Daniel Vitt: Fire. I want to extend our thanks again to everyone who has been able to join us for the event, both in person and those who listen to the recordings. Alternately, we announced that extended data from our phase two emphasis trial of the Fudemous Calcium in patients with relapsing, remitting, might of the sclerosis, RMS was published in the prestigious peer-reviewed journalism, Neurology, Neurology, Neuroimmunology and Neuroinflammation, an official journal of the American Academy of Neurology. The paper leads authored by Dr. Bob Fox from Cleveland Clinic, who is also the coordinating investigator of our insurer in Caliber programs, included data for both study cohorts with an extended dose range.

Speaker Change: I want to extend our thanks again to everyone, who is able to join us for the event.

Daniel Vitt: We also shared our strong belief that media flumeous 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 anti-barrel effects. In combination with its favourable safety and tolerability proof. Fire.

Speaker Change: Both in person and those who listen to the recordings.

Daniel Vitt: Also in April, we announced that extended data from our Phase II Emphasis Trial of Pedophilimus Calcium in patients with relapsing-remitting multiple sclerosis, or RMS, was published in the prestigious peer-reviewed journal Neuroimmunology and Neuroinflammation, an official journal of the American Academy of Neurology. The paper, led by Dr. Bob Fox from Cleveland Clinic, who is also the coordinating investigator of our Insure and Calibre programs, included data for both study cohorts with an extended dose range.

Speaker Change: Ultimately appropriate knowledge that extended data from all phase II emphasis trial, if we defer them as calcium in patients with relapsing remitting multiple sclerosis, RMS was published in the prestigious peer reviewed journal neurology neurology, new neuro immunology and euro inflammation.

Speaker Change: An official journal of the American Academy of Neurology.

Daniel Vitt: I want to extend our thanks again to everyone who has able to join us for the event, both in person and those who listen to the recordings. Author April, we announced that extended data from our phase two emphasis trial of the de-photomous calcium in patients with relapsing, remitting, might of the sclerosis, RMS was published in the prestigious peer-reviewed journalism, neurology, neurology, neuroimmunology, and neuroinflammation, an official journal of the American Academy of Neurology.

Speaker Change: The paper lead authored by Dr. Bob Fox from Cleveland Clinic was also the coordinating investigator of our insured and chemical programs included data from both study cohorts with an extended dose range.

Daniel Vitt: Inclusion in the publication represents further evidence of the strength of these findings for the Fudemous Calcium in RMS. In May, we had the opportunity to present data from our clinical programs at various scientific conferences.

Daniel Vitt: Inclusion in the publication represents further evidence of the strength of these findings for VFK in RRMS. In May, we had the opportunity to present data from our clinical programs at various scientific conferences. First, human data from our Phase 1b clinical trial of INU856, our orally available and systemically acting small molecule modulator that targets 136 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 a gluten-free diet and gluten challenge demonstrated meaningful improvements compared to a placebo in four key dimensions of celiac disease pathophysiology, specifically histology, disease symptoms, biomarkers, and nutrient absorption.

Speaker Change: Inclusion in the publication represents further evidence of the strength of these findings for each of whom is calcium in our IMS.

Speaker Change: In May we had the opportunity to present data from our clinical programs at various scientific conferences.

Daniel Vitt: First in human data from our phase one B clinical trial of I-U-856 are already available and systemically acting small molecule modulator. The target 136 in patients with celiac disease was presented in an oral presentation at the Digestive Disease Week in Washington, DC. 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, antneutral absorption. I-U-86 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 R-SARP approach to a range of gastrointestinal disorders through the regeneration of bowel architecture.

Daniel Vitt: The paper, lead authored by Dr. Bob Fox from Cleveland Clinic, who is also the coordinating investigator of our insurer in Calibur program, 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 the de-photomous calcium in RMS. In May, we had the opportunity to present data from our clinical programs at various scientific conferences. First in human data, from our phase one B clinical trial of I-U-856, our already available and systemically acting small molecule modulator, the target 136 in patients with celiac disease was presented in an oral presentation at the ingestive disease week in Washington, DC.

Speaker Change: First in human data from our phase one b clinical trial of <unk> 856 are already available and systemically acting small molecule modulator that target certain six in patients with celiac disease was presented in an oral presentation at digestive disease week in Washington D C.

Speaker Change: The Tri 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 at neutral absorption.

Daniel Vitt: MUHF6 was also observed to be safe and well-tolerated in this study. 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. Additionally, we presented data from our Phase II Caliper trial of B.difluminus calcium in patients with progressive multiple sclerosis, or PMS, at two conferences. The 23rd National Congress of Neurology in Golden Sands, Bulgaria, and the Consortium of Multiple Sclerosis Centers 38th Annual Meeting in Nashville.

Speaker Change: And your H F. Six 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.

Speaker Change: Roche to arrange of gastrointestinal disorders through the regeneration of bone architecture.

Daniel Vitt: 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 paraphecyology. Specifically, histology, disease symptoms, biomarkers, and nutrient absorption. I-U-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 R-SARP approach to a range of gastrointestinal disorders through the regeneration of our architecture.

Daniel Vitt: Additionally, we represent data from our phase two caliper trial of I-U-Mus Calcium in patients with progressive multiple sclerosis or PMS at two conferences. The 23rd National Congress of Neurology in Golden Sands, Bulgaria, and the production of multiple sclerosis centers, 38th Annual Meeting in Nashville. We were pleased to have the opportunity at both meetings to highlight the clear separation observed in serum neurofileminide chain, NFL, Faviter-Mus calcium over placebo in this PMS patient population. As it represents another significant step forward for what could potentially be a first-in-class, no-one 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.

Speaker Change: Additionally, we presented data from our phase II caliper trial of either the luminous calcium in patients with progressive multiple sclerosis, or Pms and two conference.

Speaker Change: The 23rd National Congress of Neurology, and Golden Sands, Bulgaria.

Speaker Change: And consortium of multiple sclerosis centers, 28th annual meeting in Nashville.

Daniel Vitt: We were pleased to have had the opportunity at both meetings to highlight the clear separation observed in serum neurofilament light chain, NFL, for beta-fluid miscalcium over placebo in this PMS patient population, as it represents another significant step forward for what could potentially be a first-in-class NOAA1 activator for MS.

Speaker Change: Europe Middle East has had the opportunity at both meetings to highlight the clear separation observed in serum European Mcglade chain Nf L. Kavita for MS. Johnson over placebo in this P. M S patient population.

Daniel Vitt: Additionally, we represent a data from our phase two caliper trial of I-U-MOS calcium in patients with progressive multiple sclerosis or PMS at two conferences. The 23rd National Congress of Neurology in Golden Sands, Bulgaria, and Cthodotum of Multiple Sclerosis Centers, 38th Annual Meeting in National. We were pleased to have had the opportunity at both meetings to highlight the clear separation of Serum in New York in the mid-July chain, N-F-L, for the different miscalcium over placebo in this PMS patient population.

Speaker Change: As it represents another significant step forward for what could potentially be a first in class <unk> activator for emmis.

Daniel Vitt: This strong signal in the NFL also makes us believe in a more likely positive outcome of the overall Caliber trial, as well as clinically relevant endpoints like prevention of disability worsening. 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 B. different miscarriages.

Speaker Change: Been strong 6 million Nf L. Also makes us believe in more likely positive outcome of the overall caliber trial as well as clinically relevant endpoints like prevention of disability worsening.

Daniel Vitt: In July, we strengthened our management team with edition of Jason Tadio 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 into the efforts to prepare for the potential commercialization of the MS calcium. Jason will also work closely with Patrick Walsh of Achieve 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.

Daniel Vitt: Jason will also work closely with Patrick Walsh, our Chief Business Officer, to prepare the company for a range of potential partnership outcomes for all pipeline assets, where we can leverage his extensive partnering experience. Additionally, Werner Gladiness 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 function. I would like to take a moment to have Jason introduce himself and to say a few words regarding the recent appointment of Simona Skajanic as a board member of the Board of Directors.

Jason Patio: In July we strengthened our management team with the addition of Jason Patio and the newly created role of Chief operating Officer and President.

Daniel Vitt: As it represents another significant step forward for what could potentially be a first-in-class, no-one activator for MS. This strong signal in N-F-L also makes us believe in a more likely positive outcome of the overall caliber trial, as well as clinically relevant endpoints, like prevention of disability worsening.

Speaker Change: <unk> proven experience in launching and commercializing Ms drugs for major biotechnology and pharmaceutical company will be.

Speaker Change: Invaluable as he will lead internal efforts to prepare for the potential commercialization of the different Ms. 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.

Daniel Vitt: Jason will also work closely with Patrick Walsh, our Chief Business Officer, to prepare the company for a range of potential partnership outcomes for all pipeline assets, where we can leverage his extensive partnering experience. Werner joined Immunic in January 2021 and has held positions of increasing responsibility since then. I would like to take a moment to have Jason introduce himself and to say a few words regarding the recent appointment of Simona Skajanic as a board member of the Board of Directors.

Daniel Vitt: In July, we strengthened our management team with addition of Jason Tadio 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 the MS. Jason will also work closely with Patrick Walsh of Achieve 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.

Speaker Change: Where we can leverage his extensive partnering experience.

Daniel Vitt: Additionally, Werner Gladiness 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.

Speaker Change: Additionally, Vernon readiness was promoted to Chief Development Officer Jonathan.

Anthony: So Anthony music in January 2021, and has held positions of increasing responsibility since then.

Vernon: In his new role he will take over additional strategic and operational responsibilities for emulex overall clinical operational functions.

Jason Tardio: I would like to take a moment to Jason introduce himself and to say a few words regarding the reason appointment of St. Mona Skianich as a board member of Board of Directors.

Speaker Change: I would like to take a moment to chase that introduce himself and to say a few words regarding the recent appointment of Simona <unk> as a board member of board of Directors Jason.

Jason Tardio: Jason. 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 catalysts, readouts for Vitofluomas Calcium over the next six to nine months. Vitofluomas Calcium has the potential to address a number of key unmet needs that still exists 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.

Jason Cardio: Thank you so much Danielle I'm delighted to be here. This morning, and truly excited to have joined the very talented team at M&A. During this pivotal time in the company's growth as.

Jason Tardio: Thank you so much, Daniel. I'm delighted to be here this morning and truly excited to have joined a 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 Vitafluvimus calcium over the next six to nine months. Fetal fluid 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.

Jason Tardio: as we prepare for a number of important catalyst readouts for beta-fluidinous calcium over the next six to nine months. Phenobalumines calcium has the potential to address a number of key unmet needs that still exist for the more than 2 million individuals living with multiple sclerosis worldwide. And I look forward to applying my experiences of launching numerous multiple sclerosis drugs during the course of my career to support Immunic as we begin preparation plans.

Speaker Change: As we prepare for a number of important catalysts readouts for beautiful them as calcium over the next six to nine months.

Speaker Change: Lowest calcium has the potential to address a number of key unmet needs that still exist at a more than 2 million individuals living with multiple sclerosis worldwide and I look forward to apply my experiences and marching numerous multiple sclerosis drugs. Then of course of my career to support M&A, because we began preparation plan.

Jason Tardio: I would like to take a moment to Jason introduce himself and to say a few words regarding the reason appointment of St.

Jason Tardio: Mona Skianich as a board member of board of directors, Jason. 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 catalysts readouts for Vittoflumous calcium over the next six to nine months. Vittoflumous calcium has the potential to address a number of key amenities that still exists for the more than two million individuals living with multiple sclerosis worldwide.

Jason Tardio: 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 preparations. I was attracted to Immunic because I believe strongly in the potential of Vita Plutimus 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. This is a unique medicine with a distinct dual mechanism of action that combines both neuroprotective effects as a first-in-class NIR1 activator with additional anti-inflammatory and antiviral effects by selectively inhibiting the enzyme DHODH.

Vernon: <unk>.

Jason Tardio: I was attracted to Immunic because I believe strongly in the potential of Vitofluomas 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. This is a unique medicine with a distinct dual mechanism of action that combines both neuro-productive effects as a first-in-class NUR1 activator with additional anti-inflammatory and anti-viral 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 Vitofluomas 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 of 2032.

Speaker Change: I was attracted to <unk>, because I believe strongly in the potential of beautiful illness calcium and at the prospect of bringing such a groundbreaking and much needed oral treatment option to patients with both relapsing and progressive forms of M. S.

Jason Tardio: This is a unique medicine with a distinct dual mechanism of action that combines both neuroprotective effects as a first-in-class NIR1 activator with additional anti-inflammatory and antiviral effects by selectively inhibiting the enzyme DHODH. 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 Vitafluminemus Calcium and IMU-856, Immunix Orally Available and Systemically Acting Small Molecule Modulator that targets SIRT6 for celiac disease and other gastrointestinal disorders, over a nearly 30-year career in the United States and international, Simona has led research and development efforts accumulating in numerous regulatory drug approvals and successful commercial launches.

Speaker Change: This is a unique medicine with a distinct dual mechanism of action that combines both neuroprotective effects as a first in class neuro, what activator with additional anti inflammatory and anti viral effects by selectively inhibiting the enzyme D. H O D H.

Jason Tardio: 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 Vittoflumous 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. This is a unique medicine with a distinct dual mechanism of action that combines both neuro protective effects as a first in class, neuro one activator, with additional anti-inflammatory and antiviral effects by selectively inhibiting the enzyme D H O D H. The data to date in both relapsing and progressive MS is encouraging and combined with a favorable safety and tolerability profile.

Jason Tardio: The data to date in both relapsing and progressive MS is encouraging. And combined with a favorable safety and tolerability profile, I believe that Vita Woman's Calcium has the potential to meaningfully enhance therapeutic options for individuals living with MS but to capture a 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. In addition to my work on helping to prepare for Commercial Readiness.

Speaker Change: The data today in both relapsing and progressive MF is encouraging and combined with a favorable safety and Tolerability profile I believe that bit of womens calcium has the potential to not only meaningfully enhanced therapeutic options for individuals living with Ms, but to capture significant share in the large global M. S. Mark.

Speaker Change: K.

Speaker Change: 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: In addition to my work on helping to prepare for commercial readiness, I look forward to working closely with our chief business officer, Patrick Gwalsh, on a range of potential partnership opportunities for both Vitofluomas Calcium and IMU-856, a minute's early available and systemically acting small molecule modulator that targets CERT-6 for celiac disease and other gastrointestinal disorders. As Daniel noted, late last month, we strengthened our board of directors with the appointment of Simona Scorjanic, 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.

Speaker Change: In addition to my work on helping to prepare for.

Patrick Walsh: 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 beautiful amiss calcium and iron new eight five secs emanates orally available and systemically acting small molecule modulator that target certain sex for celiac disease.

Jason Tardio: I look forward to working closely with our Chief Business Officer, Patrick Walsh, on a range of potential partnership opportunities for both Vitafluminemus Calcium and IMU856, Immunix'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 Skorjanec, a thought leader in brain health with decades of experience in drug development and commercialization.

Jason Tardio: I believe that Vittoflumous 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 of 2032. In addition to my work on helping to prepare for commercial readiness, I look forward to working closely with our Chief Business Officer, Patch Gwalsh on a range of potential partnership opportunities for both Vittoflumous calcium and IMU 856.

Speaker Change: And other gastrointestinal disorders.

Jason Tardio: Over a nearly 30-year career in the United States and abroad, Simona has led research and development efforts resulting in numerous regulatory drug approvals and successful commercial launches, working at companies such as Roche, The Medicines Company, Eli Lilly, Pfizer, and Johnson & Johnson. 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 Ocolizumab, which remains one of the most successful medicines for the treatment of MS.

Speaker Change: As Daniel noted late last month, we strengthened our board of directors and the appointment of Tomorrow are chatting, a thought leader in brain health with decades of experience in drug development and commercialization.

Speaker Change: Over our nearly 30 year career in the United States and internationally Sonoma Simona has led research and development efforts cumulated in numerous regulatory drug approvals and successful commercial launches working at companies such as rush, the medicines company, Eli Lilly Pfizer and Johnson <unk> Johnson.

Jason Tardio: IMU is an early available and systemically acting small molecule modulator that target CERT-6 for celiac disease and other gastrointestinal disorders. As Daniel noted, late last month, we strengthened our Board of Directors with the appointment of Simona Scrojane, 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.

Daniel Vitt: It is worth pointing out that Simona led business and global corporate strategy for rocious portfolio of neurological and rare diseases, achieving sustainable, double, double digit growth and sales, including with O'Creative's Oracle ISMAP, which remains one of the most successful medicines for the treatment of MS. I will now turn the call back over to Daniel. Thank you, Jason. We are very proud and excited that both you and Simona joined the Munich team.

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

Speaker Change: It is worth pointing out that Simona led business and global corporate strategy for roche's portfolio of neurological in rare diseases.

Speaker Change: Leaving sustainable a double the double digit growth in sales, including without Creatives Oracle is map, which remains one of the most successful medicines for the treatment of M. S.

Daniel Vitt: I will now turn the call back over to Daniel.

Speaker Change: I will now turn the call back over to Dan.

Daniel Vitt: Yeah, thank you, Jason. We are very proud and excited that both you and Simona have 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 renewable calcium in MS. That concludes our summary of the second quarter of 2024 and most recent highlights. We remain pleased with the clinical and operational advancements we are making across our programs.

Daniel Vitt: Yeah, thank you, Jason. We are very proud and excited that both you and Simona are joined with the Immunic team.

Speaker Change: Yeah. Thank you Jason.

Daniel Vitt: We are very proud and excited that both you and Simona have 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 renewable calcium in MS. That concludes our summary of the second quarter of 2024 and most recent highlights. As it relates to our lead asset, videofluvimus calcium, we are advancing both our phase II caliper trial in patients with progressive MS and our twin phase III ensured trials in patients with relapsing MS. Additionally, as mentioned in our previous calls, we are currently exploring different options to further fund phase 2 clinical development of IMU856 in celiac disease and potentially other GI indications.

Speaker Change: We are very proud and excited that both you and Simona joined Munich team Simona track record in drug development and commercialization combined with Jason's experience in launching and commercializing Ms drugs really strengthened in Munich, as we work towards the potential commercial launch I'll be nuclear Wisconsin and M. S.

Daniel Vitt: Simona's track record in drug development and commercialization combined with Jason's experience in launching and commercializing MS drugs, really is Jameson's immunic as we work towards the potential commercial launch of Vittorblumas Cardstone in the 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 Vittorblumas Cardstone, we are advancing both our phase two caliper trials in patients with progressive MS and our twin phase three insured 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.

Speaker Change: Yeah.

Speaker Change: That concludes our summary of our second quarter 2020 report and most recent highlights we remain pleased with it clearly couldn't operationally mountain, we are making across our programs.

Daniel Vitt: As it relates to our lead asset, VDF calcium, we are advancing both our phase 2 Caliper trial in patients with progressive MS and our twin phase 3 Ensure trials in patients with relapsing MS. Based on the strong technical evidence to date, we continue to pursue partnering discussions with both global and regional pharmaceutical companies. Our team has also been busy advancing our IMU-HF6 program, which has the potential to become a game changer for the treatment of a broad range of GI disorders.

Speaker Change: As it relates to our lead asset video for the MS. Calcium we advancing both our phase II clinical trial in patients with progressive Ms and I want to really face reinsurance rides with relapsing Ms.

Daniel Vitt: Simona's track record in drug development and commercialization, combined with Jason's experience in launching and commercializing MS drugs, really shines in unique as we work towards the potential commercial launch of Vittemus Kaplan in MS. That concludes our summary of the second quarter 2024 and most recent highlights. We remain pleased with the clinical and operational advancement we are making across our programs. As it relates to our lead asset Vittemus Kaplan, we are launching both our phase two calipers trial in patients with progressive MS and our twins phase three insured trials with relaxing MS. Based on the strong clinical evidence to date, we continue to pursue partnering discussions with both global and regional pharmaceutical companies.

Speaker Change: Based on the strong clinical evidence to date, we continue to pursue partnering discussions with both global and regional pharmaceutical companies.

Daniel Vitt: Our team has also been busy advancing our HF-6 program, which has the potential to become a game changer for the treatment of a broad range of GI disorders.

Speaker Change: Our team has also been busy advancing our <unk> hundred six program, which has the potential to become a game changer for the treatment of a broad range of Gi disorders.

Daniel Vitt: As mentioned in our previous call already, we are currently exploring different options to further fund phase two clinical development of M2-HF-6 in CLEAC disease and potentially other GI indications.

Daniel Vitt: As mentioned in our previous calls already, we are currently exploring different options to further fund phase 2 clinical development of IMU856 in celiac disease and potentially other GI indications. I would now like to turn the call over to Glenn to provide a financial overview.

Speaker Change: As mentioned in our previous calls already we are currently exploring different options to further fund phase II clinical development of mine to April six in celiac disease and potentially other Gi indications.

Glenn Whaley: I would now like to turn the call over to Glenn to provide a financial overview. Glenn? Thank you, Daniel. I will now review the financial and operating results for the second quarter and six months ended June 30, 2024.

Speaker Change: I would now like to turn the call over to Glenn to provide financial overview Glenn.

Glenn Wailea: Thank you Daniel.

Glenn Whaley: I will now review the financial and operating results for the second quarter and six months ended June 30, 2020. 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. For the six months ended June 30th, 2024, R&D expenses were $37 million, as compared to $44.19 million for the six months ended June 30th, 2024.

Glenn Whaley: I will now review the financial and operating results for the second quarter and six months ended June 30th, 2020. First, I will start with a review of our cash position.

Glenn Wailea: I will now review the financial and operating results for the second quarter and six months ended June 30 of 'twenty 'twenty four.

Daniel Vitt: Our team has also been busy advancing our IMJHF6 program, which has the potential to become a game changer for the treatment of the broad range of GI disorders. As mentioned in our previous call already, we are currently exploring different options to further fund phase two clinical development of IMJHF6 in celiac disease and potentially other GI indications.

Glenn Whaley: Let me start with a review of our cast position. We ended the second quarter of 24, 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 Vita Flutomus calcium program.

Glenn Whaley: 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 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.

Glenn Wailea: Let me start with a review of our cash position. We ended the second quarter of 'twenty four.

Glenn Wailea: 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.

Speaker Change: Regarding the operating results.

Glenn Whaley: I would no like to turn the call over to Glenn to provide financial overview Glenn. Thank you, Daniel. I will now review the financial and operating results for the second quarter and six months ended June 30th, 2024.

Speaker Change: R&D expenses were $18 3 million for the three months ended June 30 of 2024.

Speaker Change: As compared to $21 2 million for the three months ended June 32023.

Speaker Change: The decrease was mainly driven by reductions in clinical development costs for the IME wait five six and I am your 935 programs. This.

Glenn Whaley: Let me start with review of our cast position. We ended the second quarter of 24 with 79.7 million in cash and cash equivalents, which we expect to be able to fund our operations into the third quarter. The third quarter of 2025 regarding the operating results are in the expenses or 18.3 million for the three months ended June 30th, 2024 as compared to 21.2 million for the three months ended June 30th, 2023.

Glenn Whaley: This was partially offset by an increase in external development costs related to the Vitaflutimus calcium program. For the six months ended June 30, 2024, R&D expenses were $37 million, as compared to $44.19 million for the six months ended June 30, 2024. 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.

Speaker Change: This was partially offset by an increase in external development cost related to Nevada fluid unless calcium program.

Glenn Whaley: For the six months ended June 30, 2024, R&D expenses were 37 million, as compared to 44.19 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 is partially offset by an increase in personal expenses.

Speaker Change: For the six months ended June 30th 'twenty 'twenty four R&D expenses were 37 million as compared to 44.19 for the six months ended June 30th trying twenty-three.

Speaker Change: The decrease was mainly driven by reductions in clinical development costs for the IME wait five six and I am your 935 programs, which was partially offset by an increase in personnel expenses.

Glenn Whaley: The decrease was mainly driven by reductions in clinical development costs for the IMU856 and IMU935 programs. This is partially offset by an increase in external development costs related to the Vietnamese calcium program. For the six months ended June 30th, 2024 R&D expenses were 37 million as compared to 44.19 for the six months ended June 30th, 2023. The decrease was mainly driven by reductions in clinical development costs for the IMU856 and IMU935 programs, which is partially offset by an increase in personal expenses. GNA expenses were 4.5 million for the three months ended June 30th, 2024 as compared to 3.8 million for the same period ended June 30th, 2023.

Glenn Whaley: GNA expenses were 4.5 million for the three months ended June 30, 2024, as compared to 3.8 million, the same period ended June 30, Lee. The increase was primarily related to personnel and legal and consultancy expenses. For the six months ended June 30th, 2024, GNA expenses were 9.6 million, as compared to 8.1 million for the same period ended June 30th, 2023. The increase was primarily related to personnel, legal, and consultancy expenses. Interest income remained unchanged at 1 million for the three months ended June 30th, 2024, as compared to the three months ended June 30th, 2023. For the six months ended June 30th, 2024, interest income was 2.2 million, as compared to 1.8 million for the same period ended June 30th, 2023.

Glenn Whaley: GNA 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. 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, 2024. The $400,000 increase was due to higher interest rates, and the change of $4.8 million was a non-cash charge related to the change in the value of the tranche rights associated with future tranches 2 and 3 of the January 2024 private placement. For the six months ended June 30, 2024, other income expense was negative $1.7 million, as compared to $1.2 million for the same period ended June 30, 2020.

Glenn Whaley: GNA 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, 2024. The increase was primarily related to personnel, legal, and consultancy expenses.

Speaker Change: G&A expenses were $4 5 million for the three months ended June 30 of 2024 as compared to 3.8 million. The same period ended June 30th trying to line three.

Speaker Change: The increase was primarily related to personnel and legal and consulting expenses.

Speaker Change: For the six months ended June 30 of 'twenty 'twenty four G&A expenses were $9 6 million as compared to $8 1 million for the same period ended June 32023.

Speaker Change: The increase was primarily related to personnel.

Speaker Change: Personnel legal and consulting expenses.

Glenn Whaley: Interest income remained unchanged at $1 million for the three months ended June 30, 2024, as compared to the three months ended June 30, 2021. 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, 2022. The 400,000 increase was due to higher interest.

Speaker Change: Interest income remained unchanged at 1 million for the three months ended June 32024, as compared to the three months ended June 30th trying twenty-three.

Glenn Whaley: Lee. The increase was primarily related to personnel and legal and consultative expenses. For the six months ended June 30th, 2024, GNA expenses were 9.6 million, as compared to 8.1 million for the same period ended June 30th, 2023. The increase was primarily related to personnel legal and consultative expenses. Interest income remained unchanged at 1 million for the three months ended June 30th, 2024, as compared to the three months ended June 30th, 2023. For the six months ended June 30th, 2024, interest income was 2.2 million, as compared to 1.8 million for the same period ended June 30th, 2023. The 400,000 increase was due to higher interest rates.

Speaker Change: For the six months ended June 30th or attorney for interest income was $2 2 million as compared to $1 8 million from the same period ended June 30th trying time three.

Glenn Whaley: The 400,000 increase was due to higher interest rates.

Speaker Change: The 400000 increase was due to higher interest rates.

Glenn Whaley: We also reported a change in fair value of the trance rights for the six months ended June 30th, 2024. The change of 4.8 million was a non-cash charge related to the change in the value of the trance rights associated with the future trances 2 and 3 of the January 2024 private placement.

Glenn Whaley: We also reported a change in fare value of the Toronto Rights for the six months ended June 30th, 2020. 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. Other income was $0.4 million for the three months ended June 30, 2024, as compared to $0.1 million for the same period ended June 30, 2022.

Speaker Change: We also reported a change in fair value of the tranche rights for the six months ended June 32024.

Speaker Change: The change of 4.8 million was a noncash charge related to the change in the value of the tranche rights associated with the future tranches, two and three of the January 'twenty 'twenty foreign private placement.

Glenn Whaley: 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 negative 1.7 million, as compared to 1.2 million for the same period ended June 30th, 2023.

Speaker Change: Other income for zero point $4 million for the three months ended June 30 of 2024 as compared to 0.19 for the same period ended June 30 of 2023.

Glenn Whaley: 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 spending on clinical trials in that country. For the six months ended June 30, 2024, other income expense was negative $1.7 million as compared to $1.2 million for the same period ended June 30, 2020.

Speaker Change: 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.

Glenn Whaley: We also reported a change in fair value of the trotch rates for the six months ended June 30th, 2024. The change of 4.8 million was a non-cash charge related to the change in the value of the trotch rates associated with the future trotches 2 and 3 of the January 2024 private placement. 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.

Speaker Change: For the six months ended June 32020 for other income expense was negative 1.7 million as compared to $1 2 million for the same period ended June 32023.

Glenn Whaley: The decrease was primarily attributable to a 1.7 million expense related to portion of costs from the January 2024 financing related to the trance rights that were established at the time of the closing of trance 1 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: 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 RMD tax incentives for clinical trials in Australia as a result of less spending for clinical trials in that country. The decrease was partially offset by an increase in foreign exchange gains.

Speaker Change: The decrease was primarily attributable to a 1.7 million expense related to portion of costs from the January January 'twenty 'twenty four financing.

Glenn Whaley: The increase was primarily attributable to an increase in foreign exchange gains, which was partially offset by 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 negative 1.7 million as compared to 1.2 million for the same period ended June 30th, 2023. The decrease was primarily attributable to a 1.7 million expense related to portion of costs from the January 2024 financing related to the trotch rates that were established at the time of the closing of trotch 1 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.

Speaker Change: Related to the tranche rates that were established at the time of the closing of tranche one.

Speaker Change: And 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.

Speaker Change: The decrease was partially offset by an increase in foreign exchange gains.

Glenn Whaley: The net loss for the three months ended June 30th, 2024 was approximately 21.4 million for 21 cents 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 54 cents per basic and diluted share, based on approximately 44.4 million weighted average common shares outstanding for the same period ended June 30th, 2023. Net loss for the six months ended June 30th, 2024, so approximately 51 million or 51 cents 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 a dollar 12 per basic and diluted share based on 44 million weighted average common shares outstanding the same period ended June 30th, 2020.

Glenn Whaley: The net loss for the three months ended June 30, 2024, was approximately $21.4 million, or 21 cents 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 ending June 30, 2020. Net loss for the six months ended June 30, 2024, so approximately $51 million, or $0.51 per basic and diluted share, based on approximately $99.6 million weighted average common share is 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 share is outstanding for the same period ended June 30, 2022. With that, I will turn the call back over to Daniel for a review of our development pipeline and upcoming milestones.

Speaker Change: The net loss for the three months ended June 32024 was approximately 21 4 million or 21 cents per basic and diluted share.

Speaker Change: Based on 101.3 million weighted average common shares outstanding.

Speaker Change: Compare to a net loss of approximately 24 million or 54 cents per basic and diluted share base.

Speaker Change: Based on approximately 44 4 million weighted average common shares outstanding for the same period ended June 30 of 2023.

Glenn Whaley: The decrease was partially offset by an increase in foreign exchange gains. The net loss for the three months ended June 30th, 2024 was approximately 21.4 million for 21 cents per basic and deleted share based on 101.3 million weighted average common shares outstanding compared to a net loss of approximately 24 million are 54 cents per basic and deleted share based on approximately 44.4 million weighted average common shares outstanding for the same period ended June 30th, 2023.

Speaker Change: Net loss for the six months ended June 30 of 'twenty 'twenty four is approximately $51 million or 51 cents per basic and diluted share based on approximately $99 6 million weighted average common shares outstanding.

Speaker Change: Third 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 30th trying twenty-three.

Glenn Whaley: Ray.

Daniel Vitt: With that, I will turn the call back over to Daniel for a review of our development pipeline and upcoming milestones. Daniel?

Speaker Change: With that I will turn the call back over to Daniel for a review of our development pipeline and upcoming milestones Daniel now.

Glenn Whaley: Net loss for the six months ended June 30th, 2024 so approximately 51 million or 51 cents for basic and deleted 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 deleted share based on 44 million weighted average common shares outstanding the same period ended June 30th, 2020.

Daniel Vitt: Now, thank you, Glenn. I would now like to provide an update on our clinical development programs and anticipated upcoming masterclasses. We plan to provide detailed insights into our MS development program at our next MS R&D Day, which we will host in New York City on September 10th. We will discuss the unique profile of ediputimus calcium and its potential to become the groundbreaking treatment of choice for both RMS and PMS patients.

Daniel Vitt: Now, thank you, Glenn. I would now like to provide an update on our clinical development programs and anticipated upcoming masterclasses. We eagerly anticipate reporting top-line data from our Phase 2 Caliper trial of B.diflumus calcium in Progress FMS 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 nonrelapsing secondary progressive MS, the progressive MS subtype with the highest unmet medical need and currently no approved therapeutics available for patients.

Daniel Vitt: Now, thank you, men. I would no like to provide an update on our chemical development programs and anticipated upcoming milestones. We eagerly anticipate reporting top-line data from all of phase two telepatriol of redevelopment's counseling and progressive MS in April of next year. If the top-line data continues to show near-protective effects, we may be able to position the drug as the first oral treatment option for non-relationsum secondary progressive MS. The program methods, the progressive MS sub-tug, with the highest Amit medical needs and currently no approved therapeutics available for patients. Additionally, we expect to report an interim fertility analysis of our phase three Ensure program in the fourth quarter of this year after approximately half of the events have occurred in the double-blind treatment periods.

Daniel: Thank you Lenny I would now like to provide an update on our clinical development programs and anticipated upcoming milestones.

Daniel: We eagerly anticipate recording topline data from our phase II <unk> trial, redeployments calcium and progressive elements in April of next year.

Speaker Change: If the top line data continues to show Neuroprotective effects, they may be able to position the drug as the first oral treatment option for non relapsing secondary progressive Ms. The procurement of the progressive M. S upturn with the highest unmet medical need and currently no approved therapeutics available for patients.

Daniel Vitt: III. With that, I will turn the call back over to Daniel for a review of our development pipeline and upcoming milestones. Daniel, now, thank you, men. I would no like to provide an update on our chemical development programs and anticipated upcoming milestones. We eagerly anticipate reporting top-line data from all of phase two telepatriol of redeveloped miscalculation and progressive MS in April of next year. If the top-line data continues to show near-protective effects, we may be able to position the drug as the first oral treatment option for non-relationsum secondary progressive MS.

Daniel Vitt: Additionally, we expect to report an interim futility analysis of our Phase III insured program in the fourth quarter of this year, after approximately half of the events have occurred in the double-blind treatment period. This analysis will allow for a non-binding fertility analysis and inform potential sample size adjustments.

Daniel: Additionally, we expect to report an interim futility analysis or a pace of three ensure a program in the fourth quarter of this year after approximately half of the events have occurred in the double blind treatment periods.

Daniel Vitt: This analysis will allow for a non-binding fertility analysis and in the form potential sample size adjustments. We further expect to complete the first of our identical twin phase three insured trials in relapsing MS in the second quarter of 2026, and the second insured trial in the second half of 2026.

Speaker Change: This analysis will allow for a nonbinding futility analysis and inform potential sample size adjustment.

Daniel Vitt: The program methods, the progressive MS sub-tug with the highest unmet medical needs and currently no approved therapeutics available for patients. Additionally, we expect to report an interim fertility analysis of our phase three 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 fertility analysis and informed potential sample size adjustments. We further expect to complete the first of our identical twin phase three insured trials in relapsing MS in the second quarter of 2026 and the second insured trial in the second half of 2026.

Daniel Vitt: We further expect to complete the first of our identical twin phase 3 insure trials in relapsing MS in the second quarter of 2026 and the second insure 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 ediputimus calcium and its potential to become the groundbreaking treatment of choice for both RMS and PMS patients.

Speaker Change: We further expect to complete the first of our identical twins phase three ensured thrive in relapsing Ms. In the second quarter of 2026, and the second ensure trial in the second half of 2026.

Daniel Vitt: 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 redevelopment's calcium and its potential to become the groundbreaking treatment of choice for both RMS and PMS patients. As I noted earlier in this call, we believe that redevelopment's calcium could meaningfully improve today's development of care, but providing the holistic solution for the full range of mass patients. The event will also feature two top-notch industry experts, Dr. Francesca Motorola from University of Hospital Turin in Italy, who is one of the leading experts for the new one target protein, as well as Dr. Amin Paor from University of Pennsylvania, who is one of the leading neuroimmunologists and well-known MS experts.

Speaker Change: We plan to provide detailed insights on our M. S development program and our next M. S. R&D day, which we will host in New York City on September 10th.

Speaker Change: We plan to discuss the unique profile opioid overdose calcium and its potential to become a groundbreaking treatment of choice for both RMS and P. M S patients.

Daniel Vitt: As I noted earlier in this call, we believe that videofibromas calcium could meaningfully improve today's standard of care by providing a realistic solution for the full range of mass patients. The event will also feature two top-notch industry experts. As previously reported, we have begun preparing for phase 2 clinical testing of MU856. 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 with the FDA.

Daniel Vitt: As I noted earlier in this call, we believe that videofilm with calcium could meaningfully improve today's standard of care by providing a realistic solution for the full range of mass patients. The event will also feature two top-notch industry experts. Dr. Francesca Mottarolo from University Hospital Turin in Italy, who is one of the leading experts for the NUR1 target protein, as well as Dr. Amit Bhaor from University of Pennsylvania, who is one of the leading neuroimmunologists and well-known MS experts. We very much look forward to having such excellent speakers at our MS R&D Day.

Speaker Change: As I noted earlier in this call. We believe that we do for them is calcium could meaningfully improve today's the little trickier, but providing a holistic solution for the full range of Ms patients.

Daniel Vitt: 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 redeveloped miscalculation 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 redeveloped miscalculation could meaningfully improve today's download of care by providing the holistic solution for the full range of mass patients.

Speaker Change: The rental also featured two top most industry experts Dr. Francesca Motorola from University Hospital to ring in Italy was one of the leading experts for the new one target proteins as well as Doctor Amit power from University of Pennsylvania, who is one of the leading neuro immunologists and one on M. S expert.

Daniel Vitt: We very much look forward to having such excellent speakers at our MS R&D Day.

Speaker Change: We very much look forward to having such excellent speakers at our analyst R&D day.

Daniel Vitt: As it relates to our second clinical stage asset, I knew 8.6. We remain very enthusiastic about this program and believe that its innovative model of action is uniquely suited to treat a broad range of serious gastrointestinal disorders, such as ciliaxylase, inflammatory bowel disease, or graft versus host disease. By targeting the physiological and intestinal epithelial regeneration, we believe I knew 8.6 treatment results in gut wall healing and the absence of broad immunosuppression. It bears repeating the data from our phase 1 B-tinical proof of concept trial of immunatrophysics in patients with ciliaxylase, which appears as gluten-free diet and gluten challenge demonstrated significant improvements over placebo and four key dimensions of clinical outcomes in ciliaxylase: protection of gut architecture, improvement of patient symptoms, enhancement of nutrient absorption, and strong biomarker response.

Daniel Vitt: As 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 physiological intestinal epithelial regeneration, we believe IMU-HF6 treatment results in gut wall healing and the absence of broad immunosup It bears repeating that data from our Phase 1b clinical proof of concept trial of IMU-856 in patients with celiac disease during periods of a 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.

Speaker Change: As it relates to our second clinical stage asset and you're eight six 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.

Daniel Vitt: The event will also feature two top-notch industry experts, Dr. Francesca Motorola from University of Hospital Turin in Italy, who is one of the leading experts for the new one target protein, as well as Dr. Amin Paor from University of Pennsylvania, who is one of the leading neuro-emunologist and well-known MS experts. We very much look forward to having such excellent speakers at our MS R&D day.

Speaker Change: By targeting the physiological intestinal immaterial regeneration, we believe I'm your 806 treatment resolved in capital healing and the absence of broad immunosuppression.

Daniel Vitt: As it relates to our second clinical stage asset, I knew 8.6. 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 CDAXA-lease, inflammatory bowel disease, or graft versus host disease. By targeting the physiological intestinal epithelial regeneration, we believe I'm your 8.6 treatment result in gut wall healing and the absence of broad immune suppression.

Speaker Change: It bears repeating the data from the lower face won't be clinical proof of concept trial of IV <unk> in patients with celiac disease during periods of gluten free diet includes insurance demonstrated significant improvements over placebo in four key dimensions of clinical outcome to the celiac disease protection of <unk>.

Speaker Change: Protector improvement of patient symptoms enhancement of Newton absorption and strong biomarker response.

Daniel Vitt: Williams. As previously reported, we have begun preparing for Faisal Khurshid to clinical testing of MU-8.6, 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 mold is important, contingent on further financing, licensing, or partnering of the acid.

Daniel Vitt: As previously reported, we have begun preparing for phase 2 clinical testing of MU856. 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 with the FDA. This brings us to the end of our formal presentation. Jessica, please open the call for a Q&A session.

Speaker Change: As previously reported we have begun preparing for phase II clinical testing of <unk> six and in addition to celiac disease. We are also exploring a number of other clinical applications.

Daniel Vitt: It bears repeating the data from our face on botanical proof of concept, trial of I'm your 8.6 in patients with CDAXA-lease, your appearance of gluten-free diet and gluten demonstrated significant improvements over placebo and four key dimensions of clinical outcomes of CDAXA-lease, protection of gut architecture, improvement of patient symptoms, enhancement of nutrient absorption, and strong biomarker response. Williams. As previously reported, we have begun preparing for phase two clinical testing of MUA-FVI, and in addition to CDAC disease, we are also exploring a number of other clinical applications for other gastrointestinal disorders, where the renewal of the gut mold is important, contingent on further financing licensing or partnering of the acid.

Speaker Change: Gastrointestinal disorders, where the renewal of the got mall is important.

Speaker Change: Engines on further financing licensing or partnering of the asset.

Unknown Executive: Let's bring them to the end of our format presentation.

Speaker Change: This brings us to the end of the Oklahoma presentation.

Jessica Breu: Jessica, please open the call for a Q&A session. Yes, 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.

Jessica Brew: Jessica Please open the call for Q&A session. Yeah. Thank you Daniela and offer 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 answer session. As a reminder, if you're trying to webcast by Edison platform that two ways to submit questions you can either submit your questions in <unk>.

Jessica Breu: 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 2 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 your 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.

Jessica Breu: 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 right-hand function of the Zoom portal to cure your question.

Speaker Change: Writing via the Q&A to office and portal or if you would like to speak with US directly Keith you with the right hand function of the same quality of care question.

Yasmeen Rahimi: Our first guest today is Yasmin Rahimi from Piper Sandler. Yes, please unmute yourself and go ahead. 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 design the your current phase three studies, ensure studies, was there always a futility built in? Is that standard protocol for MS studies, if you could talk about that? 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?

Jessica Breu: Let's bring this to the end of our former presentation. Jessica, please open the call for Q&A session. Yes, 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 cure your question.

Speaker Change: Our first guest today is yasmin Rahimi from Piper Sandler Yes, please amongst yourselves and go ahead.

Operator: Good morning, team. Thank you so much for all the great updates.

Yasmeen Rahimi: Good morning, team. Thank you so much for all the great updates.

Yasmin Rahimi: Morning, Tim. Thank you so much for all the great updates Hum few questions for you I guess one of the questions is when you design that youre kind of phase III studies, and <unk> studies, which are always a fatality belt and if that is that standard.

Daniel Vitt: I have a few questions for you. I guess one of the questions is, when you design your current phase three studies, the ensure studies, was there always futility built in? Is that a standard protocol for MS studies, if you could talk about that? And also kind of dissect out what are the possible outcomes, what is the likelihood that there will need to be a sample size adjustment? So we'd love for you to sort of tackle that, and then I have a follow-up question in regards to caliber.

Operator: I have a few questions for you. I guess one of the questions is when you design your current phase 3 studies, insurance studies, was there always futility built in? Is that a standard protocol for MS studies, if you could talk about that? And also kind of dissect out what are the possible outcomes, what is the likelihood that there will need to be a sample size adjustment? So, we'd love for you to sort of tackle that, and then I have a follow-up question in regards to caliber.

Speaker Change: Call for advanced studies, if you could talk about that.

Speaker Change: And and also kind of dissect out what are the possible what is the likelihood that there will need to be a sample type adjustments I would love for you to sort of tackle that and then I have a follow up in regards to caliber.

Yasmeen Rahimi: Our first guest today is Yasmin Rahimi from Piper Santa. Yes, please unmute yourself and go ahead. 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 design your current phase three studies, ensure studies, was there always a futility built in? Is that standard protocol for MS studies if you could talk about that and also kind of dissect out what are the possible, what is the likelihood that there will need to be a sample size adjustment?

Yasmeen Rahimi: And then I have a follow-up in regards to caliber.

Daniel Vitt: Yeah, thank you, Yasmeen. And very clearly, yes, from the very beginning, futility was built into that study. One of the main reasons is that it's an event-driven study, and we just wanted to make sure that not for just random things, but 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 sample size adjustment options where the committee can say yes or no. So it's a very straightforward and important thing. And I think it really just ensures that the money of those phase three studies is really well invested, and we succeed in the overall program.

Daniel Vitt: Yeah, thank you, Yasmin.

Jasmine: Yes, Thank you Jasmine.

Speaker Change: Sure.

Daniel Vitt: 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 rather than a study. And we just wanted to make sure that not for just random things. We are unsure on a couple of patients. And, as you know, with futility analysis, you need to pre-define the questions. And therefore we have only a limited small number of sample size adjustment options, where the committee can say yes or no. So it's a very straight and important thing.

Speaker Change: And very clear, yes. It was initially.

Speaker Change: From the very beginning with utility was built into that into that study one of the main reasons is it's an event driven study mhm and we just wanted to make sure that not for just random.

Speaker Change: Things.

Speaker Change: We run short on a couple of patients.

Speaker Change: And as you know the futility analysis, you need to predefined the questions and endeavor, we have only.

Yasmeen Rahimi: So would love for you to sort of tackle that, and then I have a follow-up in regards to Calibur. Yes, thank you Yasmin. 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 eventism study and we just wanted to make sure that not for just random things, we are unsure on a couple of patients. And as you know, the futility analysis, you need to pre-define the questions.

Speaker Change: Only a limited small number often sample size adjustment options, whereas the committee can say, yes or no. So it's a it's the various trades.

Speaker Change: And upon thing and.

Daniel Vitt: And I think it really makes just ensure that the money of those phase three studies is really well invested and we succeed in the overall program. Thank you.

Speaker Change: I think it is.

Speaker Change: It really makes just ensures that the money of those phase III studies really well invested and we succeeded in the overall program.

Daniel Vitt: Okay, thank you. And then, in regards to caliber, obviously, you know, the primary endpoint is looking at brain volume change. I think in the past, you have talked about sort of a 15% change being sort of reflective. I would love for you to kind of go back as we go into April, what do you hope to see and analyze volume rate, and also some of the key secondaries, right? Like, what are the ones that we should be able to maybe pick up statistical differences, maybe a reminder of what are considered clinically meaningful differences.

Speaker Change: Okay. Thank you and then in regards to caliber 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 and reflective I would love for you to kind of go back as we go into April.

Yasmeen Rahimi: And then in regards to caliber, obviously, the primary and point 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.

Yasmeen Rahimi: And therefore we have only a limited small number of sample size adjustment options where the committee can say yes or no. So it's a very straight and important thing. And I think it really makes just ensure that the money of those tests we study is really well invested and we succeed in the overall program. Okay, thank you. And then in regards to Calibur, obviously, you know, the primary endpoint is looking at the brain volume change.

Yasmeen Rahimi: I would love for you to kind of go back as we go into April. What do you hope to see in analytics volume rate? And also some of the key secondaries, right? Like what are the 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, the 25, but walk tests, et cetera.

Speaker Change: What do you hope to see an MLA as volume rate and also some of the key secondaries ride like what are the ones that we should be able to maybe pick up statistical differences, maybe a reminder, what I'll consider clinically meaningful differences. Obviously, you guys have magic nicely in a number of key secondaries.

Daniel Vitt: Obviously, you guys are measuring a number of key secondary outcomes, from the EDSS scores to the 25 foot walk tests, etc. So I would love for you to kind of talk about that as well. Then I'll jump back into the queue. Yeah.

Speaker Change: The E D. S. S course for that 25, but walk tests et cetera. So I'd love for you to kind of talk about that as well and then I'll jump back into the queue.

Yasmeen Rahimi: 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 analytics volume rate? And also some of the key secondaries, right? Like what are the ones that we should be able to maybe pick up statistical differences, maybe a reminder of what are considered clinically meaningful?

Daniel Vitt: So we'd love for you to kind of talk about that as well, and then I'll jump back into the queue. Yeah, I'm very happy that you asked the question because I think Jennifer is really could be a nature transformative study for MS patients and also for the company. And as you said, the primary and final of the study is brain volume change between placebo and the 45-megamactose dose. And, but as you said, I think there are secondary endpoints which are medically also very meaningful, and you mentioned the EDS change, so confront disability worsening. The official secondary or key secondary endpoint is 24; we confirm disability worsening, which will also report in April.

Daniel Vitt: Yeah, I'm very happy that you asked the question, because I think CALIBRA 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. And, 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 or key secondary endpoint is 24. We confirmed disability worsening, which we will also report in April.

Speaker Change: Yeah, I'm very happy that you asked the question because I think caliber is really could be a major transformative study.

Speaker Change: The study for MS patients and also for the company and as I said the primary endpoint of the study is brain volume change.

Speaker Change: Between placebo and the 45 milligram active dose.

Yasmeen Rahimi: Difference is obviously you guys are measuring nicely a number of key secondaries from the EDSS scores to the 25, but walk tests, et cetera. So I would love for you to kind of talk about that as well. And then I'll jump back into the queue. Yeah, I'm very happy that you asked the question because I think caliber is really could be a nature transformative study for MS patients and also for the company.

Speaker Change: And but at the end as you said I think there are secondary endpoints, which are medically also very meaningful and you mentioned.

Speaker Change: The eds S change so confirmed disability worsening sort of the the official secondary key secondary endpoint is 24 week confirmed disability worsening, which will also report in April.

Daniel Vitt: And on top of that, there are other parameters that could help us to understand to what extent videofluidemous calcium has neuroprotective effects, and part of that, as you mentioned, cognitive functions. We have the nine-hole PECT test, we have the 25-foot walk test, and these standard things implemented in the study, and we also will report on those. And all of those are meaningful, I think.

Daniel Vitt: And on top of that, there are other parameters which could help us to understand to what extent video footage was calcium has new protective effects, and part of that are, as you mentioned, cognitive functions. We have the nine hole pectast, we have the 25 foot walk test and these benefit things implemented in the study, and we also will report on those. And all of those, I mean, for 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.

Speaker Change: And on top of that there are other parameters, which could help us to understand to what extend video for the Ms calcium as neuroprotective effects and part of that as you mentioned cognitive functions.

Yasmeen Rahimi: And as you said, the primary and final of the study is brain volume change between placebo and the 45-million-mactose dose. And but as you said, I think there are secondary endpoints which are medically also very meaningful and you mentioned the EDS change, so confirmed disability worsening, so that the the official secondary or key secondary end point is 24, we confirmed disability worsening, which will also report in April. And on top of that, there are other parameters which could help us to understand to what extent the fluid was calcium has new protective effects and part of that are, as you mentioned, cognitive functions.

Speaker Change: We have the nine hole Peg test, we have the 25 foot walk test and he's been at things implemented in the study and we also will report on those and all of those are meaningful I think the study was really designed to them to give them a full picture we have.

Daniel Vitt: 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. But what I can't tell you and others right now is what the acceptable threshold of activity here is. As you mentioned, a 15% benefit on disability protection would be medically relevant, I think, but there is no official number that is meaningful here. But in the absence of any treatment, for example, for nonrelapsing secondary and progressive, every step forward would be perceived as a success, I think.

Speaker Change: Randomized 467 patients overall in the study, it's a big study and we have high expectations.

Daniel Vitt: Got it. Thank you so much.

Speaker Change: What we can see here.

Yasmeen Rahimi: What I can't tell you and others right now is what is the exact threshold of activity here. As you mentioned, a 15% benefit on disability protection would be something medically relevant. And I think, but there is no official number of what is here meaningful. But in the absence of any treatment, for example, for non-relapsing secondary and progresses, every step forward would be perceived as a success, I think. Got it.

Speaker Change: But I can't tell you and others right now is what is the exact threshold of activity here as you mentioned.

Yasmeen Rahimi: We have the nine hole pectast, we have the 25 foot walk test and these benefit things implemented in the study and we also will report on those. And all of those I mean what 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.

Speaker Change: A 15% benefit on disability protection would be something medically relevant.

Speaker Change: And I think but there is no official number one this year meaningfully and whatnot, but in the absence of any treatment for example for non relapsing secondary progresses every step forward would be perceived as a as a success I think.

Speaker Change: Okay.

Yasmeen Rahimi: Thank you so much. Thank you.

Speaker Change: Got it thank you so much.

Daniel Vitt: Yeah, thank you, Yasmeen. Thank you, Yasmeen. Next one in the queue here is Matt Kaplan from Lindenbrook-Tailman. Matt, please unmute yourself, and welcome to the poll. Hi, good morning, guys, and thanks for taking the questions. It's just a follow-up to Yasmeen'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. Yeah.

Yasmeen Rahimi: Yes, me.

Matt Kaplan: And can you help me think he has mean next one in the queue here as Matt Kaplan from Ladenburg Thalmann massive unmet yourself inlet convertible.

Yasmeen Rahimi: Thank you. Yes, me.

Matt Katlin: I mean, the next one in the queue here is Matt Katlin from LandmobTelman. Matt, please come with yourself and welcome to the poll. Hi, good morning, guys, and thanks for taking the questions. It's just a follow-up to you as means question on cattle per just give us a give us a sense in terms of why the interim NFL change that you observed in the study make you confident or give you confidence in the outcome of the study. That will see you in April.

Yasmeen Rahimi: As you mentioned, a 15% benefit on disability protection would be something medically relevant, I think, but there is no official number of what is here, meaning, but in the absence of any treatment, for example, for non-relapsing secondary progresses, every step forward would be perceived as a success. Yes, I think. Got it. Thank you so much. Thank you. Thank you, you have me.

Operator: Hi, good morning guys, and thanks for taking the questions. It's just a follow-up to Yasmeen's question on Caliper.

Matt Kaplan: Hi, Good morning, guys and thanks for taking the questions. So just a follow up to asking his question.

Matt Kaplan: On caliber just give us a give.

Matt Kaplan: Give us a sense in terms of why the interim NFL changes that you observed.

Speaker Change: And the study, making you confident I'll give you a confidence in the outcome of the study that we'll see in April.

Daniel Vitt: Yeah, thank you and good morning, Matt. That's a very good question because we did a lot of work on really understanding the role and the relevance of NFL for predicting disability outcomes. And I think most of the hints why that is believed to be relevant are coming from the newer literature of other studies. I think one of the most important, maybe the most important in that context was a very good paper published last year, with the main author, Amit Bhaor, as I said, who will join us for the MS R&D Day in September.

Daniel Vitt: Yeah, thank you.

Daniel Vitt: Good morning, Matt. That's a very good question because we spent a lot of work on really understanding the roles and the relevance of NSL for predicting disability outcome. And I think the most of the hints why that is believed to be rather than is coming from the new literature of other studies. I think one of the most important, maybe the most important in that context, was a very good paper published last year. But the main author, Amit Bahar, 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 Oakley Summab study, the oratorio study in a primary progressive MS. And they clearly have shown that if you really focus on those patients which don't show relapses and don't show information.

Speaker Change: Thank you and good morning, Matt, but that's a very good question because we spent a lot of work on really understanding the roles and the relevance of Nf L for predicting disability outcome.

Matt Katlin: Next one in the queue here is Matt Katlin from Lennemortelman. Matt, please come with yourself and welcome to the poll. Hi, good morning, guys, and thanks for taking the questions. Just a follow-up to Yasmeen's question on Caliper.

Speaker Change: I think the most of the the the hints why that is believed to be rather then is coming from the newer literature of other studies.

Daniel Vitt: 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. Yeah, thank you. Good morning, Matt. That's a very good question because we spent a lot of work on really understanding the roles and the relevance of NSL for predicting disability outcome. And I think the most of the hints why that is believed to be rather than is coming from the new literature of other studies.

Speaker Change: I think one of the most important maybe the most important in that context was a very good paper published last year.

Speaker Change: But the main author amidst the arm as I said, who will join us for the MSR R&D day in September and he was the main author of the paper on <unk> study.

Daniel Vitt: And he was the main author of the paper on the Eucalyptus map study, the oratorial study in primary progressive MS. And they clearly have shown that if you really focus on those patients who don't show relapses and don't show inflammation, and they did it by re-basing the study population, then a lower NFL level at baseline is predictive of future disability, of a lower rate of disability worsening for So that's why it's a pretty big data set, and I think it was really nice that they had shown that there was this correlation, which was statistically significant.

Matt Kaplan: The oratorio study in primary progressive Ms and they clearly have shown that issue.

Matt Kaplan: You really focus on those patients, which don't show relapses and dosing information.

Daniel Vitt: And they did it by rebase lining the study population. Then the lower NSL level at baseline is predictive of future disability outcome of a lower rate of disability worsening for the patients at low NSL. So that's why it's a pretty big data set, and that thing was really nice that they have shown that there is this correlation, which was statistically significant. There are other hints from non-inventional studies, interventional studies, where also this relation was shown. The point is that we think that NSL is a very good tool, but we need to be very careful on really separating inflammatory from non-inflammatory patients at the evaluation.

Matt Kaplan: And they did it by re baseline in the study population than the Aloha Nf L.

Daniel Vitt: I think one of the most important, maybe the most important in that context was a very good paper published last year. But the main author, Amit Bahar, as I said, who will join us for the MSR and GD in September. And he was the main author of the paper on Oakley's Enough Study, the oratorio study and a primary progressive MS. And they clearly have shown that if you if you really focus on those patients which don't show relapses and don't show information and they did it by rebase lining the study population.

Matt Kaplan: Leather at baseline is predictive of future disability open off of a lower rate of disability worsening for the patients with low NFL. So that's why it's a pretty big data has had enough thing was really nice but they have shown that there is this correlation which was statistically significant there other hands.

Daniel Vitt: There are other hints from non-interventional studies where this relation has also been shown. The point is that we think that NFL is a very good tool, but we need to be very careful when really separating inflammatory from non-inflammatory patients during the evaluation. And therefore, looking back on the interim data we reported last October for CALIFOR, a statistically significant 22% reduction of NFL compared with the active plus between active and placebo, we think that makes us very optimistic about a readout on the disability protection and next April after the full 120 week data.

Speaker Change: Non invention studies Interventional studies, where also this relation was shown the point is that we think that Nf L was a very good too, but we need to be very careful on really separating inflammatory phenomenal inventory patients.

Daniel Vitt: Then the lower NSL level at baseline is predictive of future disability outcome of a lower rate of disability worsening for the patients at low NSL. So that's why it's a pretty big data set and that thing was really nice but they have shown that there is this correlation which was statistically significant. There are other hints from non-inventional studies, intervention studies, where also this relation was shown. The point is that we think that NSL 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: And therefore, looking back on the interest rate that we reported last October for Calibur with... and a statistically significant 22% reduction of NFL compared with the active, 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.

Speaker Change: Thank you your emulation and therefore looking back on the on the interim data we reported last October for caliber with.

Speaker Change: A statistically significant 22% reduction of NFL compared with the active plus.

Matt Kaplan: Between active and placebo with things that makes us very optimistic on a readout.

Matt Kaplan: On the disability protection and next April.

Matt Kaplan: After the full 120, a week data.

Matt Katlin: Thank you, Daniel, that's very helpful. Yeah, thank you, Matt.

Operator: Thanks, Daniel. That's very helpful. Yeah. Thank you, Matt. Thank you, Matt.

Daniel Vitt: Thanks, Daniel. That's very helpful. Yeah. Thank you, Matt. Thank you, Matt.

Matt Kaplan: Yeah. Thanks, Danielle that's very helpful. Yeah. Thank you Matt.

Thomas Smith: Thank you, Matt. The next one in the queue here is Tom Smith from Leering Partners. Tom, please unmute yourself, and welcome.

Daniel Vitt: And therefore looking back on the on the entrance data we reported last October for Calibur with.., and a statistical, significant 22% reduction of NFL compared with the active, between active and placebo. We think that makes us very optimistic on a readout on the disability protection in April, after the full 120-week data. Thank you, Daniel. That's very helpful. Yeah, thank you, Matt. Thank you, Matt.

Matt Katlin: Thank you, Matt.

Matt Kaplan: Thank you Matt next one in the queue here, it's Tom Smith from Leerink partners commonplace unmet yourself and welcome.

Tom Smith: Next one in the queue, here is Tom Smith from Learning Partners. Tom, please unmute yourself and welcome. Hey guys, good morning. Thanks for taking the questions. Just one on the data fluidiness. I mean, you mentioned you continue to explore partnership and other business development opportunities. Can you just elaborate on the level of engagement with Farman now? I guess how that's evolved over the last 12 months and what you're looking for in a potential partner?

Thomas Smith: Hey guys, good morning. Thanks for taking the questions. Just one on beta flutamins. 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?

Tom Smith: Hey, guys. Good morning, Thanks for taking the questions.

Speaker Change: Just one on <unk>.

Speaker Change: <unk> you mentioned you continue to explore partnership and other business development opportunities can.

Tom Smith: 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 Youre looking for in a potential partner.

Jason Tardio: Yeah, happy. Maybe Jason, would you like to take over a good question? Sure. So, look, when we think about partnerships, clearly, our goal is, if this medicine is successful, to ensure that we can get it to as many patients as quickly as possible, right? And therefore, not only help patients that continue to have on that need, but also to increase value for the economy. And so, we're exploring a variety of different potential partnerships that is not limited to just full-out licensing. It could be regional out licensing. It could be partnerships around profit share and others.

Daniel Vitt: Yeah, happy. Maybe Jason would like to take over that question? Sure. So let's

Matt Kaplan: Yeah Happy maybe Jason would you like to take over.

Tom Smith: Next one in the queue here is Tom Smith from Learing Partners, Tom, please unmute yourself and welcome. Hey guys, good morning. Thanks for taking the questions.

Jason: That question sure. So look when we think about partnerships clearly you know our our goal is that this medicine is successful would be to ensure that we can get it to as many patients as quickly as possible right and therefore.

Jason Tardio: So, look, when we think about partnerships, clearly, you know, our goal would be, if this medicine is successful, to ensure that we can get it to as many patients as quickly as possible, right? And therefore, not only help patients that continue to have unmet needs 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 are not limited to, you know, just full out licensing. It could be regional out licensing.

Jason Tardio: Just one on the data fluidiness. 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? Yeah, happy. Maybe Jason, would you like to take over? 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?

Jason Tardio: And therefore, you know, not only help patients that continue to have on that 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.

Speaker Change: You know not only help our patients has continued to have unmet need but also to increase.

Jason Tardio: We believe that if necessary and if needed, we will go forward ourselves and begin to build commercial plans to launch this 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. Got it. That makes sense.

Jason: Value for for the company and for shareholders and so we're exploring a variety of different potential partnerships.

Jason Tardio: 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 joined the company.

Matt Kaplan: That is not limited to just fall out licensing it could be regional out licensing it couldnt be partnerships around our profit share and others again.

Jason Tardio: Again, we're building expertise in-house, as Daniel has mentioned. It's a big reason why I've joined the company. We believe that if necessary and if needed, we will go forward ourselves and begin to build commercial plans to launch this 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. Got it, that makes sense.

Matt Kaplan: We're building expertise in houses as Daniel has mentioned it says it's a big reason why I joined the company.

Matt Kaplan: We believe that if necessary and if needed we will go forward ourselves and begin to build our commercial plans to launch this 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.

Jason Tardio: 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 about both, you know, large global but also regional potential partnerships. And we look forward to sharing additional information in the future.

Matt Kaplan: Not mentioned specifics at this time for both you know large global but also original potential partnerships and we look forward to sharing additional information in the future.

Thomas Smith: Got it. That makes sense. And then, just one on 856. I was just wondering if you could provide a little bit more color on where you stand with the phase two plans to be engaged with or receive feedback from the FDA. And then, I guess, what are the gating factors to starting the celiac study?

Speaker Change: Got it that makes sense.

Matt Katlin: And then just one on 8 5 6.

Speaker Change: And then just one on on eight five sexy I was just wondering if you could provide a little bit more color on where you stand with the phase.

Daniel Vitt: Yeah, I was just wondering if you could provide a little bit more color on where you stand with the phase 2 plans to be engaged with or receive feedback from the FDA. And then, I guess, what are the gating factors to starting the celiac study?

Speaker Change: Phase two plans, Serbia engaged with or receive feedback from the FDA and then.

Speaker Change: I guess what are the gating factors to starting the celiac study.

Daniel Vitt: Yeah, I think, 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 HF6 programs. And we want to do that in a hopefully broad way, 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 that we are working on in the preparation of protocols, discussing with experts, exploring potential sites, and so forth. That's actively ongoing.

Daniel Vitt: Yeah, I think, 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 vision of financing for infrastructure programs. And we want to do that in a hopefully broad way to not just bad on one indication, but also hopefully being able to do more than one clinical application here. And there are three options we have on a table, and we are working on in that preparation of protocols, discussing with experts, exploring potential sites, and so forth. It's actively ongoing.

Speaker Change: Yeah, I think as I said the focus of the company is really right now to ensure the full performance and speed of the EMS programs. Therefore, we we are looking for independent additional financing for it from six programs and we want to do that in a in a hopefully broad way too not just bet on one.

Daniel Vitt: And then just one on on 856. Yeah, I was just wondering if you could provide a little bit more color on where you stand with the phase two plans to be engaged with or receive feedback from the FDA. And then I guess what are the gating factors to starting the Celiac study? Yeah, I think as I said, the focus of the company is really right now to ensure the full performance and speed of the MS programs.

Matt Kaplan: One indication, but also hopefully being able to do more than one clinical application here and there are three options we have on the table and we're working on.

Matt Kaplan: And the preparation of protocols.

Matt Kaplan: Cutting with experts exploring potential signs of that so for instance, actively ongoing saudis are as awkward celiac disease.

Daniel Vitt: Therefore, we are looking for independent vision of financing for infrastructure programs. And we want to do that in a hopefully broad way to not just bat on one indication, but also hopefully being able to do more than one clinical application here. And there are three options we have on a table and we are working on in that preparation of protocols, discussing with experts, exploring potential sites and so forth. It's actively ongoing.

Daniel Vitt: 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, specifically, it's a smaller niche indication, but the mode of action perfectly fits there, is graft-versus-host disease.

Daniel Vitt: So, these are, of course, CDI disease at the indication where we have already received very good proof of concept data. But also in us, the provided and as a certain indication, which is interesting, specifically, it's a smaller niche and occasion, but the mode of action perfectly fits there is ground versus so these are the three things you're looking at. And in that context, we have some regulatory discussions, and we think we have a clear plan forward, and kind of most work is done in discussions with investors and potential partners to make sure we have the right.

Matt Kaplan: The indication we have already.

Speaker Change: <unk> received very good proof of concept data.

Matt Kaplan: But also in of the provider and as a third indication, which is interesting specifically as a smaller niche indication.

Matt Kaplan: The mode of action perfectly fits there this graph versus host disease. So these are the three things we're looking at.

Daniel Vitt: So, these are the three things we are looking at. And in that context, we have had some regulatory discussions, and we think we have a clear plan forward. And currently, most work is done in discussions with investors and potential partners to make sure we have the right design and the right content together to take the next big steps into phase two.

Matt Kaplan: And in that context, we have some regulatory discussions and we think we have a clear plan forward and kind of most work is done in discussions with investors and potential partners to make sure. We have the right design and bill right.

Daniel Vitt: So these are of course, the eye disease at the indication where we have already received very good proof of concept data. But also in us the provided and as a certain indication, which is interesting, specifically, it's a smaller niche and occasion, but the mode of action perfectly fits there is ground versus so these are the three things you're looking at. And in that context, we have some regulatory discussions. And we think we have a clear plan forward and kind of most work is done in discussions with investors and potential partners to make sure we have the right design and the right, to go the next big steps into phase two studies. Yeah, that makes sense. Thanks for taking the questions. You know, thank you, John. Thank you, John.

Daniel Vitt: Design and the Right. Concent together to go the next big steps into phase two studies. Yeah, that makes sense.

Matt Kaplan: Concept together to go the next big steps into Phase II studies.

Speaker Change: Got it that makes sense. Thanks for taking the questions and thank you John Thank you Tom.

Matt Katlin: Thanks for taking the questions. Thank you, John.

Thomas Smith: Got it, that makes sense. Thanks for taking the questions. Yeah, thank you, John. Thank you, John. 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.

Unknown Executive: Once again, if you have a question, please use the raised hand function of the Zoom portal or the Q&A tool, and I see some more here in the queue.

Speaker Change: And once again, if you have a question. Please use the raise hand function opportune product or the Q&A tool and I see some more here in the queue I would like to welcome next Tyler <unk> from Brookline, Tyler and let yourself in go ahead.

Tyler Bussian: I would like to welcome next, Tyler Bussian from Brookline. Tyler, please admit yourself and go ahead. Thank you, Daniel. Thanks for taking the time. What question on the potential beta readouts from Califer? Obviously, since you did mind the trial, you had a large amount of data talking about the neuroprotective sex and secondary mechanisms compared to traditional DHRDH inhibition. I just kind of wanted to get a sense of a lot of those neuroprotective readouts come through. There are any possibilities for expedited review, fast-track that's mentioned from the FDA. What I guess kind of gives that a possibility, and what type of results would you need to see for something like that?

Tyler: Thanks for taking the time up quick question on the potential data Readouts from caliper, obviously since you designed the trial.

Tyler Bussian: 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 DHRDH inhibition. I just kind of wanted to get a sense of whether there are any possibilities for, you know, expedited review, fast track that's made from the FDA? What, I guess, is that a possibility, and what type of results would you need to see for something like that?

Speaker Change: A large amount of data talking about the dark checking.

Speaker Change: Secondary mechanisms.

Tyler: Traditional EHR D H inhibition I just don't know.

Jessica Breu: Once again, if you have a question, please use the right hand function of the Zoom portal or the Q&A tool, and I see some more here in the queue.

Tyler: Wanted to get a sense of a.

Speaker Change: A lot of those Neuroprotective readouts come through is there any possibilities.

Tyler: Expedited review fast track designation from the FDA.

Tyler Bussian: I would like to welcome next Tyler Bussian from Brookline. Tyler, please, I'm not yourself and go ahead. I'm just going to send Daniel thanks for taking the time.

Tyler: I guess is that a possibility.

Tyler: Or something like that.

Daniel Vitt: Yeah, thank you for the question, Tyler. Of course, I depend on the data that's the answer you always get with all sorts of questions, but I think you're right. Given the absence of real treatments for non-renafcing secondary progressive, and also considering that 60% of the 467 patients in the study have a non-renafcing secondary progressive MS. This is an area of huge amit need, and I think also the regulators are aware of this around the world. If the data is good and a good means showing a relevant, medically meaningful protective effect, for example, on disability worsening, on brain viral change, and maybe also other cognitive parameters.

Daniel Vitt: Yeah, thank you for the question, Tyler. Of course, it depends on the data. That's the answer you always get with such questions.

Tyler: Yes. Thank you for the question Tyler.

Daniel Vitt: What question on the potential beta readouts in caliper? Obviously, since you did mind the trial, you had a large amount of data talking about the neuroprotective sex and kind of secondary mechanisms compared to traditional DHRDH inhibition. I just kind of wanted to get a sense of a lot of those neuroprotective readouts come through.

Speaker Change: Of course that depends on the data that's the answer your lowest countries offer such situations, where I think you are right given the absence of real treatments for non relapsing secondary progressive and also considering that 60% of the 467 patients in the study.

Daniel Vitt: But I think you're right. Given the absence of real treatments for non-relapsing secondary progressive MS 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 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.

Daniel Vitt: There are any possibilities for, you know, expedited review, fast-track that's mentioned from the FDA. What I guess kind of give that a possibility and what type of results would you need to see for something like that? Yeah, thank you for the question, Tyler. Of course, I depend on the data that's the answer you always get with all sorts of questions, but I think you're right. Given the absence of real treatments for non-renafcing secondary progressive and also considering that 60% of the 467 patients in the study.

Tyler: Has a non relapsing secondary progressive Ms.

Tyler: This is a.

Tyler: An area of huge unmet need and I think also the regulators are aware of this around the world.

Tyler: So if the data is good.

Tyler: Good means.

Speaker Change: I'm showing irrelevant medically meaningful.

Tyler: Protective effect for example on disability worsening.

Tyler: On brain volume change and maybe also other cognitive parameters.

Daniel Vitt: We, of course, will try to discuss to what extent we are able to expedite the track towards approval. 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 something we'll really be happy to do. Great, thank you very much.

Daniel Vitt: We will, of course, try to discuss with the regulators to what extent we are able to expedite the track towards approval. In a positive case, it could really be a much quicker way to get the drug to the patients, and I think it's something we'd really be happy to do. Great, thank you.

Daniel Vitt: I have a non-renafcing secondary progressive MS. This is an area of huge amount of need and I think also the regulators are aware of this around the world. So if the data is good and a good means showing a relevant medically meaningful protective effect, for example, on disability worsening on brain viral change and maybe also other cognitive parameters. We, of course, will try to discuss the regulars to what extent we are able to expedite the track towards approval. 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 something we'll really be happy to do.

Tyler: We of course will trying to discuss with the regulators to what extent, we are able to expedite.

Speaker Change: The trend towards approval that tuned.

Speaker Change: And in a positive case, it could really be a very much quicker way to get the drug to the patients.

Speaker Change: It's something we'd really be happy to do.

Speaker Change: Great. Thank you for your time.

Tyler Bussian: Thank you, Tyler.

Tyler Bussian: Thank you, Tyler. Thank you. Next one here is Madison Alzadi from the Riley School. Madison, good morning. Please unmute yourself.

Operator: Thank you, Tyler. Thank you. Next one here is Madison Alzadi from the Riley School. Madison, good morning. Please unmute yourself.

Tyler: Thank you Tyler.

Medicine Alzadi: Thank you. Next one here is medicine Alzadi from the Riley Medicine. Good morning.

Operator: Thank you.

Operator: Next one here as medicine.

Speaker Change: <unk> from B Riley Madison, Good morning, Kiss and make yourself.

Medicine Alzadi: Please unmute yourself. Hey guys. Good morning. We can hear you, but we have a feedback. Yeah, I think it's six now. Yeah, that's better. Thank you. Thank you for taking our question. So a couple from me, kind of starting high. So given the missed out we've seen with the BTK class, I'm just kind of wondering your expectations for this class. You think we've already seen the filling of efficacy and kind of the four of 60. This class and maybe if there's a scenario where. You become you're able to kind of leapfrog this class and become the world therapy of choice.

Operator: Okay.

Madison Alzadi: Hey, guys.

Operator: Yeah.

Madison Alzadi: Okay, good morning. We can hear you, but we have a problem.

Operator: Sure.

Speaker Change: Good morning, we can hear you, but we have a feedback.

Madison Alzadi: Yeah, I think I think it's fixed now. Yeah, that's better. Thank you. Thank you for taking our question.

Speaker Change: I think I think it's six now.

Madison Alzadi: Better thank you.

Madison Alzadi: Thanks for taking our question. So a couple from me kind of starting to fight so given the missteps, which seem with the BK class I'm just kind of wondering your expectations for this class and we think we've already seen.

Madison Alzadi: So a couple from me kind of starting. 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 filling 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

Tyler Bussian: Great, thank you. Thank you, Tyler. Thank you.

Madison Alzadi: Next one here is medicine alzadi from the Riley medicine. Good morning. Please unmute yourself. Hey guys. Good morning. We can hear you, but we have a feedback. Yeah, I think I think it's six now. Yeah, that's better. Thank you. Thank you, thank you for our question. So a couple from me kind of starting. So given the missed out we've seen with the BTK class, I'm just kind of wondering your expectations for this class.

Madison Alzadi: Are the filling of efficacy in kind of a floor of safety for this class.

Speaker Change: Maybe if there's a scenario where.

Speaker Change: You become you're able to kind of leapfrog this drug class and they come to oral therapy of choice.

Daniel Vitt: Yeah, I think, um, of course, the. The evolution of data was a disappointment for the patients and we need to all. 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 I think there's still some in development, and I think the market is expecting data, for example, from Sanofi soon. On the internet data. I think already my perception is that the even put in a table data really opened doors for us because they more or less it's recognized that there is a.

Daniel Vitt: Yeah, I think, of course, the Iverbutrinib data was a disappointment for the patients. And we all need to admit that the industry tried really hard to develop that class of PTK inhibitors as a next option for RMS and PMS. And there, I think, are still some in development.

Speaker Change: Yeah, I think of course the.

Madison Alzadi: If you think we've already seen the filling of efficacy and kind of the four of 60. This class and maybe if there's a scenario where you become, you're able to kind of leapfrog this class and become the world therapy of choice. Yeah, I think, of course, the, the evolution of data was a disappointment for the patients. And we need to all, we all need to admit that the industry tried really a lot to develop that.

Speaker Change: <unk> data was a disappointment for the patients and we need to all we all need to admit that the industry tried to really a lot to develop that class a PTK inhibitors as the next option for <unk>.

Speaker Change: <unk> and Pms.

Speaker Change: And there I think there's still some in development and I think the market is expecting data for example from Sanofi soon.

Daniel Vitt: And I think the market is expecting data, for example, from Sanofi soon on Iverbutrinib. But I think already my perception is that the Iverbutrinib data really opened doors for us because they more or less recognized that there was a good alternative, an interesting molecule with a new mode of action. First in class, the one activator, which could fill into a potentially lower number of other alternative development candidates in the BTK pipeline.

Speaker Change: On the atone importantly data.

Speaker Change: I think already my perception is that the <unk> data are really opened doors for us because he's more of an asset to recognize that there is a.

Daniel Vitt: Good alternative, an interesting molecule with a new mode of action. First thing, last but one activity, which could fill into here potentially lower number of other alternative development candidates in the BTK pipeline. 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 US for some of the BTK inhibitors. They are setting development, and we will see what's coming out of the studies there.

Speaker Change: Good alternative and interesting molecule with a new mode of action first in class the monarch, two data rich could fill into here potentially.

Madison Alzadi: 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. And they've totally put in a data. I think already my perception is that the even put in a table data really opened doors for us because they more or less recognize that there is a. Good alternative, an interesting molecule with a new mode of action, first thing class, the one activator, which could fill into here potentially lower number of other alternative development candidates in the BTK pipeline.

Speaker Change: Lower number of other alternative development candidates in the BTG pipeline. So we are yes, we clearly think that we see already that the market has that impression.

Daniel Vitt: So 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 US for some of the BTK inhibitors. They are still in development, and we will see what comes out of the study.

Speaker Change: But it's still open I think despite the the.

Speaker Change: The clinical holds in the U S for some of the EBT case inhibitors. They are still in development and we will see what's coming out of the study is Dan.

Operator: Okay, great. Thank you.

Madison Alzadi: Okay, great. Thank you.

Daniel Vitt: Okay, great, thank you. And then secondly, so assuming the face to Calibur's positive, is it too early to talk about next steps, if you'll go straight to kind of face three. And if so, you know, was that the, you know, PPM or active or not active SPMS population? Are you thinking, you know, kind of a wider population targeting all of PMS? Yeah, actually, should we do that? I think this is our duty. We need to think about it. We already, the clinical team is working on the protocol for phase three in PMS. And regardless, if we get expedited approval or not, the phase three will be needed. We know that one of the phase three should be sufficient for progressive MS. And also clearly the focus is likely, and also looking on the intermediate, the focus will likely be first on non-relapsing, secondary or progressive MS, given absence of any other treatments there, that makes it medically the quickest and the high demand indication, and therefore, and the drugs seem to work in this difficult retreat population, at least based on the biomarker side.

Speaker Change: Okay, great. Thank you and then secondly.

Madison Alzadi: So assuming our phase two calibers positive.

Madison Alzadi: And then secondly, so assuming the phase 2 caliber is positive, is it too early to talk about next steps? If you'll go straight to kind of phase 3, and if so, would that be in a PPM or active or non-active SPMS population? Or are you thinking, you know, kind of a wider population targeting all of PMS?

Operator: And then secondly, so assuming the phase 2 caliber is positive, is it too early to talk about next steps if you'll go straight to kind of phase 3? And if so, you know, would that be in a PPM or active or non-active SPMS population? Or are you thinking, kind of a wider population targeting all of PMS?

Madison Alzadi: Is it too early to talk about Nextel stops yoga strictly phase three.

Madison Alzadi: 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 the development and we will see what's coming up with the studies there. Okay, great. Thank you. And then secondly, so assuming the face to caliber is positive, is it too early to talk about next steps, if you'll go straight to kind of face three?

Operator: And if so would that be <unk> or active or not active as pls population centers decking.

Speaker Change: A wider.

Speaker Change: Population targeting all of Pls.

Daniel Vitt: Yeah, sure we're doing that. I think this is our duty. We need to think about it.

Daniel Vitt: Yeah, sure, we're doing that. I think this is our duty. We need to think about it.

Speaker Change: Yeah sure. We are doing that I think is or our duty we need to think about it we already that the clinical team is working on the protocol floor for phase III in Pms.

Daniel Vitt: The clinical team is working on the protocol for phase 3 in PMS, and regardless if we get expedited approval or not, phase 3 will be needed. We know that one phase three should be sufficient for progressive MS, and also, clearly, the focus will likely be first on non-relapsing secondary progressive MS, given the 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 biomarkers.

Daniel Vitt: We already, the clinical team is working on the protocol for phase three in PMS. And regardless if we get expedited approval or not, phase three will be needed. We know that one phase three should be sufficient for progressive MS. And also, clearly, the focus will likely be first on non-relapsing secondary progressive MS, given the absence of any other treatments there that make it medically.

Daniel Vitt: And regardless, if we get expedited approval or not the phase III will be needed to renew that one phase III should be sufficient for for progressive and mass and also clearly the focus is likely and also looking on the interim the focus will likely be first on non relapsing secondary progressive Ms. Given absence of any other.

Madison Alzadi: And if so, you know, was that the, you know, PPM or active or non-active SPMS population, or you're thinking, you know, kind of a wider population targeting all of PMS? Yeah, should we do that? I think this is our duty. We need to think about it. We already, the clinical team is working on the protocol for phase three in PMS. And regardless, if we get expedited approval or not, the phase three will be needed, we know that one of the phase three should be sufficient for for progressive MS. And also clearly the focus is likely, and also looking on the internet, the focus will likely be first on non-relapsing secondary or progressive MS, given absence of any other treatments there that makes it medically, the quickest and the high demand indication, and therefore, and the drugs need to work in the difficult retreat population, at least based on the biomarker side.

Daniel Vitt: Treatments, there that makes sense medically.

Daniel Vitt: The quickest and the high demand indication and therefore in the drug seems to work.

Daniel Vitt: In this difficult to treat population at least based on the biomarker side. So yeah, I think that that's the way forward and from our point of view however.

Daniel Vitt: So, yeah, I think that that's the way forward from our point of view. However, as Jason said, this is also not to be seen in the global strategy. It could be a piece of a global partnership. 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 they are and what options we have on the table then in the second quarter of next year.

Medicine Alzadi: So, yeah, I think that that's the way forward from our point of view. However, as Jason said, this is also not that we've seen in the global strategy; it could be a piece of a global partnership. So there are other ways. Let's look at the data. When we're doing the homework, we are prepared for different options, but I think the most important pieces to get the data and to see how strong are they and what options do we have on the table than in the second quarter of next year? Got it. Thank you.

Jason Tardio: As Jason said this.

Speaker Change: This is also notably senior leader in the global strategy it could be a piece of a global partnership.

Speaker Change: So there are other ways, let's look at the data.

Daniel Vitt: We're doing the homework, we are prepared for a different options.

Daniel Vitt: But I think the most important pieces to get the data and to see them. How strong are they and what options do we have on the table then.

Daniel Vitt: In the second quarter of next year.

Madison Alzadi: So yeah, I think that's the way forward from our point of view. However, as Jason said, this is also not that we've seen 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 than in the second quarter of next year. Got it. Thank you. Great. Thank you, Madison. All right, this concludes our question and answer session today.

Madison Alzadi: Got it. Thank you. Thank you.

Speaker Change: Got it thank you.

Medicine Alzadi: Great. Thank you, Madison.

Speaker Change: Thank you Greg Thank you Madison.

Unknown Executive: All right, this concludes our question and answer session today.

Daniel Vitt: Thank you. Great. 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: Alright. 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: I would like to turn the conference back over to Daniel for any closing remarks. 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 face to collateral trial expected in April of next year and the ongoing enrollment of our face three insured trials. We continue to make tangible progress with our lead program because of the miscalculation. Importantly, with 79.7 million or 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 calibration.

Daniel Vitt: Okay.

Daniel Vitt: 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, B. leupholomus calc.

Daniel Vitt: Thank you Jessica and thanks to all of today's attendees for your always insightful questions.

Daniel Vitt: 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 clinical trial expected in April of next year and the ongoing enrollment of our phase III insured lives. We continued to make tangible progress with our lead program.

Daniel Vitt: I would like to turn the conference back over to Daniel for any closing remarks. Thank you, Jessica. And thanks to all of today's attendees for your always-insetful 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 face to collateral trial expected in April of next year and the ongoing enrollment of our face pre-insured trials.

Speaker Change: For the most calcium.

Daniel Vitt: Possibly.

Speaker Change: With $79 7 million on our 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 caliber rebound. Additionally, as progress is made in contingent on financing licensing or partnering we expect to also provide an update on our preparations for a phase II clinical <unk>.

Daniel Vitt: Additionally, as progress is made and contingent on financing, licensing, or partnering, we expect to also provide enough data in our preparations for a Phase Two clinical trial of IMUATRA 6 and its unique potential for the treatment of a broad array of serious gastroenteritis or Thomas Smith.

Speaker Change: <unk> of <unk>, six and its unique potential for the treatment of a broad array of serious gastrointestinal disorders.

Daniel Vitt: We continue to make tangible progress with our lead program, beautiful Miss Karschen. Importantly, with 79.7 million dollar 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 delivery route. Additionally, as progress is made and contingent on financing, licensing or partnering, we expect to also provide enough data in our preparations for a face-to-clinical trial of I-NUATRA 6 and its unique potential for the treatment of a broad array of serious With that, I would like to close today's call.

Daniel Vitt: With that, I would like to close today's call.

Daniel Vitt: With a $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 caliber redoubt. 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 INU-HF6 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 us. And We are very happy to answer any additional questions one by one, so please do not hesitate to reach out.

Daniel Vitt: With that I would like to close today's call. Thank you again for joining Andrew.

Jessica Breu: 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.

Daniel Vitt: And we are very happy to answer any additional questions. One by one so please do not hesitate to reach out.

Unknown Executive: And thank you for joining us on your next second quarter 2024 earnings call. The call is now concluded. You may now disconnect.

Unknown Executive: Thank you for joining in the next second quarter 2024 earnings calls.

Speaker Change: For joining <unk> second quarter 2024 earnings call. The call has now concluded you may now disconnect.

Unknown Executive: The call is now concluded. You may now disconnect. Thank you very much.

Unknown Executive: Good bye.

Daniel Vitt: Goodbye.

Unknown Executive: 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.

Q2 2024 Immunic Inc Earnings Call

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