Johann Wolfgang Goethe-Universität Frankfurt am Main

CAMBRIDGE, Mass. & SALISBURY, England--( BUSINESS WIRE )-- KalVista Pharmaceuticals, Inc. (NASDAQ: KALV), today announced that it presented additional analyses of the efficacy and safety of sebetralstat from phase 2 and phase 3 double-blind, placebo-controlled crossover clinical trials as well as interim data from KONFIDENT-S, a phase 3 open-label extension trial, and real-world patient data at the Bradykinin Symposium 2024 taking place in Berlin, Germany, on September 5-6. Sebetralstat is a novel, investigational oral plasma kallikrein inhibitor for the on-demand treatment of hereditary angioedema (HAE) attacks in adult and pediatric patients aged 12 years and older. “ Delay or denial in the treatment of HAE attacks is often related to the administration of the currently approved injectable on-demand treatments which commonly result in injection-site reactions or pain. The data presented today highlight that oral sebetralstat may remove these challenges and has a safety profile no different than placebo,” said Emel Aygören-Pürsün, MD, specialist in internal medicine at the Division of Oncology, Hematology and Hemostaseology at the Department for Children and Adolescents of the University Hospital Frankfurt, and a leading investigator for the phase 2, phase 3 KONFIDENT and KONFIDENT-S trials. “ Sebetralstat also resulted in rapid symptom relief in the clinical trials. If approved, sebetralstat might become a major advance for people living with HAE by addressing critical gaps in the current standard of care for on-demand treatment of attacks.” “ We are encouraged by the observation of exceptional consistency of both safety and efficacy across the entire clinical program for sebetralstat for the on-demand treatment of HAE,” said Paul Audhya, MD, MBA, Chief Medical Officer of KalVista Pharmaceuticals. “ These data reinforce the potential for sebetralstat to transform the management of HAE.” The presentations at Bradykinin Symposium 2024 included: Delayed On-demand Treatment of Hereditary Angioedema Attacks and Associated Barriers Reported by Italian patients: Mauro Cancian, Azienda Ospedaliera, Università degli Studi di Padova, Padova, Italy (Oral presentation) Many patients did not meet guideline recommendations for early on-demand treatment following attack recognition, which resulted in more severe attacks. Pooled Sebetralstat Placebo-controlled Efficacy for On-demand Treatment of Hereditary Angioedema: Emel Aygören-Pürsün, University Hospital Frankfurt, Goethe University Frankfurt, Germany (Poster presentation) Pooled analysis of a larger number of HAE attacks corroborates the efficacy of sebetralstat for on-demand treatment, offering an oral administration route to potentially enable early treatment and rapid symptom relief. Pooled Sebetralstat Placebo-controlled Safety for On-demand Treatment of Hereditary Angioedema: Emel Aygören-Pürsün, University Hospital Frankfurt, Goethe University Frankfurt, Germany (Oral presentation) In the pooled safety analysis in phase 2 and phase 3 double-blind, placebo-controlled crossover trials, sebetralstat was well-tolerated with a safety profile no different than placebo. KONFIDENT-S Interim Analysis: Sebetralstat for Hereditary Angioedema Attacks Including Laryngeal: Henriette Farkas, Hungarian Angioedema Center of Reference and Excellence, Semmelweis University, Budapest, Hungary (Oral presentation) Among 640 attacks treated, median time to treatment was 9 minutes for all attacks and 8 minutes for laryngeal attacks; the median time to beginning of symptom relief was 1.8 hours for all attacks and 1.3 hours for laryngeal attacks. Phase 3 KONFIDENT Trial of Sebetralstat for HAE: European Subgroup: Andrea Zanichelli, Operative Unit of Medicine, Angioedema Center, IRCCS Policlinico San Donato, San Donato Milanese, Milan, Italy; Department of Biomedical Sciences for Health, University of Milan, Milan, Italy (Poster presentation) In the KONFIDENT phase 3 clinical trial, the positive efficacy and safety of sebetralstat as an on-demand treatment for HAE was consistent between European participants and the overall cohort. A specific, sensitivity assay measuring patient sample plasma kallikrein activity : Daniel Lee, KalVista Pharmaceuticals (Oral presentation) Measuring specific plasma kallikrein activity could be useful as a biomarker for normal C1INH, which currently has no standardized diagnostic pathway. Links to all posters and presentations can be found on the KalVista website under Publications . About Sebetralstat Discovered and developed entirely by the scientific team at KalVista, sebetralstat is a novel, investigational oral plasma kallikrein inhibitor for the on-demand treatment of hereditary angioedema (HAE). Sebetralstat received Fast Track and Orphan Drug Designations from the U.S. FDA, as well as Orphan Drug Designation and an approved Pediatric Investigational Plan from the European Medicines Agency (EMA). About Hereditary Angioedema Hereditary angioedema (HAE) is a rare genetic disease resulting in deficiency or dysfunction in the C1 esterase inhibitor (C1INH) protein and subsequent uncontrolled activation of the kallikrein-kinin system. People living with HAE experience painful and debilitating attacks of tissue swelling in various locations of the body that can be life-threatening depending on the location affected. All currently approved on-demand treatment options require either intravenous or subcutaneous administration. About KalVista Pharmaceuticals, Inc. KalVista Pharmaceuticals, Inc. is a global pharmaceutical company focused on the development and delivery of oral medicines for diseases with significant unmet need. KalVista announced positive phase 3 data from the KONFIDENT trial for its oral, on-demand therapy, sebetralstat for HAE in February 2024. The Company’s NDA for sebetralstat has been accepted by the FDA with a PDUFA goal date of June 17, 2025. In addition, KalVista received validation of its MAA from the EMA in August 2024. KalVista expects to file for approval in the UK, Japan, and other countries later in 2024. For more information about KalVista, please visit www.kalvista.com or follow on social media at @KalVista and LinkedIn . Forward-Looking Statements This press release contains "forward-looking" statements within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. Forward-looking statements can be identified by words such as: "anticipate," "intend," "plan," "goal," "seek," "believe," "project," "estimate," "expect," "strategy," "future," "likely," "may," "should," "will" and similar references to future periods. These statements are subject to numerous risks and uncertainties that could cause actual results to differ materially from what we expect. Examples of forward-looking statements include, among others, timing or outcomes of communications with the FDA, our expectations about safety and efficacy of our product candidates and timing of clinical trials and its results, our ability to commence clinical studies or complete ongoing clinical studies, including our KONFIDENT-S and KONFIDENT-KID trials, and to obtain regulatory approvals for sebetralstat and other candidates in development, the success of any efforts to commercialize sebetralstat, the ability of sebetralstat and other candidates in development to treat HAE or other diseases, and the future progress and potential success of our oral Factor XIIa program. Further information on potential risk factors that could affect our business and financial results are detailed in our filings with the Securities and Exchange Commission, including in our annual report on Form 10-K for the year ended April 30, 2024, our quarterly reports on Form 10-Q, and our other reports that we may make from time to time with the Securities and Exchange Commission. We undertake no obligation to publicly update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise.

NEW YORK, Sept. 4, 2024. Immunic, Inc., a biotechnology company developing a clinical pipeline of orally administered, small molecule therapies for chronic inflammatory and autoimmune diseases, today announced enrollment of the first patient in an investigator-sponsored phase 2 clinical trial of its lead asset, nuclear receptor related 1 (Nurr1) activator, vidofludimus calcium (IMU-838), entitled, "Randomized Adaptive Assessment of Post COVID Syndrome Treatments_Reducing Inflammatory Activity in Patients with Post COVID Syndrome (RAPID_REVIVE)." "There remains an urgent need for the treatment of Post COVID Syndrome (PCS) and its related symptoms, including physical function and fatigue," stated Prof. Dr. Maria J.G.T. Vehreschild, Head of the Department of Infectious Diseases at the University Hospital Frankfurt and Principal Investigator for the RAPID_REVIVE trial. "That said, vidofludimus calcium is an ideal candidate for our trial, due to its proven antiviral and anti-inflammatory effects, as well as its potential ability to prevent Epstein-Barr virus (EBV) reactivation and reduce fatigue. We look forward to further enrolling patients in this trial." "We are honored to have vidofludimus calcium chosen for this investigator-sponsored trial, run by such highly regarded investigators at esteemed institutions in Germany," added Daniel Vitt, Ph.D., Chief Executive Officer of Immunic. "We have seen convincing data supporting vidofludimus calcium's antiviral effects in our preclinical and clinical studies and its ability to reduce fatigue in patients from our phase 2 CALVID-1 trial. Importantly, third-party research has identified EBV reactivation as a potential cause for fatigue, one of the most dominating symptoms for both PCS and multiple sclerosis (MS) patients, negatively impacting their quality of life and ability to participate in social activities. We aim to confirm the ability of vidofludimus calcium to influence fatigue and EBV reactivation in our ongoing MS trials and look forward to receiving additional data from the RAPID_REVIVE trial. It is our belief that this may create yet another differentiating feature for this product candidate." In patients with PCS, fatigue is by far the most prevalent symptom. Similarly, fatigue is frequently experienced by MS patients, often to such an extent that it interferes with quality of life. Recent third-party data in PCS patients have identified EBV reactivation as a leading risk factor and potential cause for fatigue in this patient group. Depending on the clinical study, EBV reactivation is observed in 55-95% of PCS patients. A recent study found detectable amounts of EBV DNA, a sign of lytic EBV reactivation, in throat washes of 50% of PCS patients experiencing fatigue compared to 20% of those without fatigue. Vidofludimus calcium is currently in phase 3 and phase 2 clinical trials for the treatment of relapsing and progressive MS, respectively. Preclinical experiments showed a dose-dependent reduction for vidofludimus calcium of lytic EBV reactivation in B cells as well as reduced lytic EBV production in Akata cells. A post-hoc analysis of Immunic's previous phase 2 CALVID-1 trial in COVID-19 patients revealed a lower prevalence of Post COVID fatigue using a patient questionnaire. Notably, 80% of patients who received placebo reported fatigue, compared to 50% who received 45 mg vidofludimus calcium. Fatigue decreased in both treatment groups over the next 9-17 weeks to 33% for placebo and to 17% for vidofludimus calcium. Given the known suppression of EBV reactivation observed for vidofludimus calcium in in vitro experiments, lowering patient's assessment of fatigue as observed in PCS patients may, potentially, also extend to MS patients. Signs of EBV reactivation and prevalence of patient-reported fatigue are also being investigated in the ongoing clinical trials of Immunic in relapsing and progressive MS patients. Study Details The phase 2 RAPID_REVIVE trial (EudraCT number: 2024-511628-16-00) is a randomized, placebo-controlled, double-blind, parallel group trial led by Prof. Dr. Vehreschild and sponsored by the Goethe University Frankfurt, which received trial funding via a grant from the German Federal Ministry of Education and Research (BMBF). The trial, for which Immunic is providing study medication, plans to enroll 376 patients at 11 clinical sites in Germany. Following a 7-day screening period during the initialization phase, patients will be randomized 1:1 to receive either vidofludimus calcium (22.5 mg initiation dose for 7 days, followed by 45 mg for 49 days) or placebo. Thereafter, a response-adaptive randomization procedure will be followed. The trial will also include a 28-day follow-up period. The primary endpoint of the trial is the intra-patient change in physical function as measured by the Short Form-36 Physical Function (SF-36-PF) from baseline to day 56. Secondary endpoints include mental and physical health, intensity of fatigue and incapacitation, severity of mental disorder symptoms, and cognitive function. About Vidofludimus Calcium (IMU-838) Vidofludimus calcium is a small molecule investigational drug in development as an oral next-generation treatment option for patients with multiple sclerosis and other chronic inflammatory and autoimmune diseases. The selective immune modulator activates the neuroprotective transcription factor nuclear receptor related 1 (Nurr1), which is associated with direct neuroprotective properties. Additionally, vidofludimus calcium is a known inhibitor of the enzyme dihydroorotate dehydrogenase (DHODH), which is a key enzyme in the metabolism of overactive immune cells and virus-infected cells. This mechanism is associated with the anti-inflammatory and anti-viral effects of vidofludimus calcium. Vidofludimus calcium has been observed to selectively act on hyperactive T and B cells while leaving other immune cells largely unaffected and enabling normal immune system function, e.g., in fighting infections. To date, vidofludimus calcium has been tested in more than 1,800 individuals and has shown an attractive pharmacokinetic, safety and tolerability profile. Vidofludimus calcium is not yet licensed or approved in any country. About Immunic, Inc. Immunic, Inc. (Nasdaq: IMUX) is a biotechnology company developing a clinical pipeline of orally administered, small molecule therapies for chronic inflammatory and autoimmune diseases. The company's lead development program, vidofludimus calcium (IMU-838), is currently in phase 3 and phase 2 clinical trials for the treatment of relapsing and progressive multiple sclerosis, respectively, and has shown therapeutic activity in phase 2 clinical trials in patients suffering from relapsing-remitting multiple sclerosis, progressive multiple sclerosis and moderate-to-severe ulcerative colitis. Vidofludimus calcium combines neuroprotective effects, through its mechanism as a first-in-class nuclear receptor related 1 (Nurr1) activator, with additional anti-inflammatory and anti-viral effects, by selectively inhibiting the enzyme dihydroorotate dehydrogenase (DHODH). IMU-856, which targets the protein Sirtuin 6 (SIRT6), is intended to restore intestinal barrier function and regenerate bowel epithelium, which could potentially be applicable in numerous gastrointestinal diseases, such as celiac disease, for which it is currently in preparations for a phase 2 clinical trial. IMU-381, which currently is in preclinical testing, is a next generation molecule being developed to specifically address the needs of gastrointestinal diseases. For further information, please visit: www.imux.com. Cautionary Statement Regarding Forward-Looking Statements This press release contains "forward-looking statements" that involve substantial risks and uncertainties for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical facts, included in this press release regarding strategy, future operations, future financial position, future revenue, projected expenses, government grants to fund clinical trials, sufficiency of cash and cash runway, expected timing, development and results of clinical trials, prospects, plans and objectives of management are forward-looking statements. Examples of such statements include, but are not limited to, statements relating to Immunic's development programs and the targeted diseases; the potential for vidofludimus calcium to safely and effectively target diseases; preclinical and clinical data for vidofludimus calcium; the timing of current and future clinical trials and anticipated clinical milestones; the nature, strategy and focus of the company and further updates with respect thereto; and the development and commercial potential of any product candidates of the company. Immunic may not actually achieve the plans, carry out the intentions or meet the expectations or projections disclosed in the forward-looking statements and you should not place undue reliance on these forward-looking statements. Such statements are based on management's current expectations and involve substantial risks and uncertainties. Actual results and performance could differ materially from those projected in the forward-looking statements as a result of many factors, including, without limitation, the COVID-19 pandemic, increasing inflation, impacts of the Ukraine – Russia conflict and the conflict in the Middle East on planned and ongoing clinical trials, risks and uncertainties associated with the ability to project future cash utilization and reserves needed for contingent future liabilities and business operations, the availability of sufficient financial and other resources to meet business objectives and operational requirements, the fact that the results of earlier preclinical studies and clinical trials may not be predictive of future clinical trial results, the protection and market exclusivity provided by Immunic's intellectual property, risks related to the drug development and the regulatory approval process and the impact of competitive products and technological changes. A further list and descriptions of these risks, uncertainties and other factors can be found in the section captioned "Risk Factors," in the company's Annual Report on Form 10-K for the fiscal year ended December 31, 2023, filed with the SEC on February 22, 2024, and in the company's subsequent filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov or ir.imux.com/sec-filings. Any forward-looking statement made in this release speaks only as of the date of this release. Immunic disclaims any intent or obligation to update these forward-looking statements to reflect events or circumstances that exist after the date on which they were made. Immunic expressly disclaims all liability in respect to actions taken or not taken based on any or all the contents of this press release. Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.

– Investigator Study Sponsored by Goethe University Frankfurt (Germany), Funded via a German Government Grant; Study Drug Vidofludimus Calcium Provided by Immunic – – In Addition to Post COVID Readouts, Study Designed to Deliver Important Data on the Activity of Vidofludimus Calcium Suppressing Epstein-Barr Virus Reactivation and Related Fatigue Symptoms; Third-Party Research Identified Epstein-Barr Virus Reactivation as Potential Cause for Post COVID Fatigue – – Severe Fatigue Also a Common and Debilitating Symptom for Multiple Sclerosis Patients with No Effective Therapies Available; Potential Read-Through to Immunic's Multiple Sclerosis Development Program – NEW YORK, Sept. 4, 2024 /PRNewswire/ -- Immunic, Inc. (Nasdaq: IMUX), a biotechnology company developing a clinical pipeline of orally administered, small molecule therapies for chronic inflammatory and autoimmune diseases, today announced enrollment of the first patient in an investigator-sponsored phase 2 clinical trial of its lead asset, nuclear receptor related 1 (Nurr1) activator, vidofludimus calcium (IMU-838), entitled, "Randomized Adaptive Assessment of Post COVID Syndrome Treatments_Reducing Inflammatory Activity in Patients with Post COVID Syndrome (RAPID­­_REVIVE)." "There remains an urgent need for the treatment of Post COVID Syndrome (PCS) and its related symptoms, including physical function and fatigue," stated Prof. Dr. Maria J.G.T. Vehreschild, Head of the Department of Infectious Diseases at the University Hospital Frankfurt and Principal Investigator for the RAPID_REVIVE trial. "That said, vidofludimus calcium is an ideal candidate for our trial, due to its proven antiviral and anti-inflammatory effects, as well as its potential ability to prevent Epstein-Barr virus (EBV) reactivation and reduce fatigue. We look forward to further enrolling patients in this trial." "We are honored to have vidofludimus calcium chosen for this investigator-sponsored trial, run by such highly regarded investigators at esteemed institutions in Germany," added Daniel Vitt, Ph.D., Chief Executive Officer of Immunic. "We have seen convincing data supporting vidofludimus calcium's antiviral effects in our preclinical and clinical studies and its ability to reduce fatigue in patients from our phase 2 CALVID-1 trial. Importantly, third-party research has identified EBV reactivation as a potential cause for fatigue, one of the most dominating symptoms for both PCS and multiple sclerosis (MS) patients, negatively impacting their quality of life and ability to participate in social activities. We aim to confirm the ability of vidofludimus calcium to influence fatigue and EBV reactivation in our ongoing MS trials and look forward to receiving additional data from the RAPID_REVIVE trial. It is our belief that this may create yet another differentiating feature for this product candidate." In patients with PCS, fatigue is by far the most prevalent symptom. Similarly, fatigue is frequently experienced by MS patients, often to such an extent that it interferes with quality of life. Recent third-party data in PCS patients have identified EBV reactivation as a leading risk factor and potential cause for fatigue in this patient group. Depending on the clinical study, EBV reactivation is observed in 55-95% of PCS patients. A recent study found detectable amounts of EBV DNA, a sign of lytic EBV reactivation, in throat washes of 50% of PCS patients experiencing fatigue compared to 20% of those without fatigue. Vidofludimus calcium is currently in phase 3 and phase 2 clinical trials for the treatment of relapsing and progressive MS, respectively. Preclinical experiments showed a dose-dependent reduction for vidofludimus calcium of lytic EBV reactivation in B cells as well as reduced lytic EBV production in Akata cells. A post-hoc analysis of Immunic's previous phase 2 CALVID-1 trial in COVID-19 patients revealed a lower prevalence of Post COVID fatigue using a patient questionnaire. Notably, 80% of patients who received placebo reported fatigue, compared to 50% who received 45 mg vidofludimus calcium. Fatigue decreased in both treatment groups over the next 9-17 weeks to 33% for placebo and to 17% for vidofludimus calcium. Given the known suppression of EBV reactivation observed for vidofludimus calcium in in vitro experiments, lowering patient's assessment of fatigue as observed in PCS patients may, potentially, also extend to MS patients. Signs of EBV reactivation and prevalence of patient-reported fatigue are also being investigated in the ongoing clinical trials of Immunic in relapsing and progressive MS patients. Study Details The phase 2 RAPID_REVIVE trial (EudraCT number: 2024-511628-16-00) is a randomized, placebo-controlled, double-blind, parallel group trial led by Prof. Dr. Vehreschild and sponsored by the Goethe University Frankfurt, which received trial funding via a grant from the German Federal Ministry of Education and Research (BMBF). The trial, for which Immunic is providing study medication, plans to enroll 376 patients at 11 clinical sites in Germany. Following a 7-day screening period during the initialization phase, patients will be randomized 1:1 to receive either vidofludimus calcium (22.5 mg initiation dose for 7 days, followed by 45 mg for 49 days) or placebo. Thereafter, a response-adaptive randomization procedure will be followed. The trial will also include a 28-day follow-up period. The primary endpoint of the trial is the intra-patient change in physical function as measured by the Short Form-36 Physical Function (SF-36-PF) from baseline to day 56. Secondary endpoints include mental and physical health, intensity of fatigue and incapacitation, severity of mental disorder symptoms, and cognitive function. About Vidofludimus Calcium (IMU-838) Vidofludimus calcium is a small molecule investigational drug in development as an oral next-generation treatment option for patients with multiple sclerosis and other chronic inflammatory and autoimmune diseases. The selective immune modulator activates the neuroprotective transcription factor nuclear receptor related 1 (Nurr1), which is associated with direct neuroprotective properties. Additionally, vidofludimus calcium is a known inhibitor of the enzyme dihydroorotate dehydrogenase (DHODH), which is a key enzyme in the metabolism of overactive immune cells and virus-infected cells. This mechanism is associated with the anti-inflammatory and anti-viral effects of vidofludimus calcium. Vidofludimus calcium has been observed to selectively act on hyperactive T and B cells while leaving other immune cells largely unaffected and enabling normal immune system function, e.g., in fighting infections. To date, vidofludimus calcium has been tested in more than 1,800 individuals and has shown an attractive pharmacokinetic, safety and tolerability profile. Vidofludimus calcium is not yet licensed or approved in any country. About Immunic, Inc. Immunic, Inc. (Nasdaq: IMUX) is a biotechnology company developing a clinical pipeline of orally administered, small molecule therapies for chronic inflammatory and autoimmune diseases. The company's lead development program, vidofludimus calcium (IMU-838), is currently in phase 3 and phase 2 clinical trials for the treatment of relapsing and progressive multiple sclerosis, respectively, and has shown therapeutic activity in phase 2 clinical trials in patients suffering from relapsing-remitting multiple sclerosis, progressive multiple sclerosis and moderate-to-severe ulcerative colitis. Vidofludimus calcium combines neuroprotective effects, through its mechanism as a first-in-class nuclear receptor related 1 (Nurr1) activator, with additional anti-inflammatory and anti-viral effects, by selectively inhibiting the enzyme dihydroorotate dehydrogenase (DHODH). IMU-856, which targets the protein Sirtuin 6 (SIRT6), is intended to restore intestinal barrier function and regenerate bowel epithelium, which could potentially be applicable in numerous gastrointestinal diseases, such as celiac disease, for which it is currently in preparations for a phase 2 clinical trial. IMU-381, which currently is in preclinical testing, is a next generation molecule being developed to specifically address the needs of gastrointestinal diseases. For further information, please visit: . Cautionary Statement Regarding Forward-Looking Statements This press release contains "forward-looking statements" that involve substantial risks and uncertainties for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical facts, included in this press release regarding strategy, future operations, future financial position, future revenue, projected expenses, government grants to fund clinical trials, sufficiency of cash and cash runway, expected timing, development and results of clinical trials, prospects, plans and objectives of management are forward-looking statements. Examples of such statements include, but are not limited to, statements relating to Immunic's development programs and the targeted diseases; the potential for vidofludimus calcium to safely and effectively target diseases; preclinical and clinical data for vidofludimus calcium; the timing of current and future clinical trials and anticipated clinical milestones; the nature, strategy and focus of the company and further updates with respect thereto; and the development and commercial potential of any product candidates of the company. Immunic may not actually achieve the plans, carry out the intentions or meet the expectations or projections disclosed in the forward-looking statements and you should not place undue reliance on these forward-looking statements. Such statements are based on management's current expectations and involve substantial risks and uncertainties. Actual results and performance could differ materially from those projected in the forward-looking statements as a result of many factors, including, without limitation, the COVID-19 pandemic, increasing inflation, impacts of the Ukraine – Russia conflict and the conflict in the Middle East on planned and ongoing clinical trials, risks and uncertainties associated with the ability to project future cash utilization and reserves needed for contingent future liabilities and business operations, the availability of sufficient financial and other resources to meet business objectives and operational requirements, the fact that the results of earlier preclinical studies and clinical trials may not be predictive of future clinical trial results, the protection and market exclusivity provided by Immunic's intellectual property, risks related to the drug development and the regulatory approval process and the impact of competitive products and technological changes. A further list and descriptions of these risks, uncertainties and other factors can be found in the section captioned "Risk Factors," in the company's Annual Report on Form 10-K for the fiscal year ended December 31, 2023, filed with the SEC on February 22, 2024, and in the company's subsequent filings with the Securities and Exchange Commission. Copies of these filings are available online at or ir.imux.com/sec-filings. Any forward-looking statement made in this release speaks only as of the date of this release. Immunic disclaims any intent or obligation to update these forward-looking statements to reflect events or circumstances that exist after the date on which they were made. Immunic expressly disclaims all liability in respect to actions taken or not taken based on any or all the contents of this press release. Contact Information Immunic, Inc. Jessica Breu Vice President Investor Relations and Communications +49 89 2080 477 09 [email protected] US IR Contact Rx Communications Group Paula Schwartz +1 917 633 7790 [email protected] US Media Contact KCSA Strategic Communications Caitlin Kasunich +1 212 896 1241 [email protected] SOURCE Immunic, Inc.