SIRT6

– Webcast to be Held at 8:00 am ET on November 7, 2024 – NEW YORK, Oct. 31, 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 that the company will release its financial results for the third quarter ended September 30, 2024, including a corporate update, on Thursday, November 7, 2024, before the opening of the U.S. financial markets. A webcast will follow at 8:00 am ET. To participate in the webcast, please register in advance at: or on the "Events and Presentations" section of Immunic's website at: ir.imux.com/events-and-presentations. Registrants will receive a confirmation email containing a link for online participation or a telephone number for dial in access. An archived replay of the webcast will be available approximately one hour after completion on Immunic's website at: ir.imux.com/events-and-presentations. 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, 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 Immunic's development programs to safely and effectively target diseases; preclinical and clinical data for Immunic's development programs; 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; the development and commercial potential of any product candidates of the company; and the company's expected cash runway. 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, including the ability to satisfy the minimum average price and trading volume conditions required to receive funding in tranche 2 and 3 of the January 2024 private placement, 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. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

NEW YORK, Oct. 29, 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 participation in the following industry, scientific and investor conferences in November: November 4-6: BIO-Europe. Members of Immunic's management, business development and investor relations teams will participate in partnering activities at this conference in Stockholm, Sweden. To schedule a meeting, please use the BIO-Europe partneringONE portal. November 8-9: Symposium 238: Immuno-Mediated Diseases of the GI Tract: Where Do We Stand? Sara Elhag, Ph.D., Associate Manager Translational Pharmacology at Immunic, will present data from the company's phase 1b clinical trial of IMU-856, an orally available and systemically acting small molecule modulator targeting SIRT6 (Sirtuin 6), in patients with celiac disease, in a poster presentation at this symposium in Florence, Italy. The poster will be accessible on the "Events and Presentations" section of Immunic's website at: . November 19-21: Immunic's management, business development and investor relations teams will be hosting one-on-one meetings in London in connection with the Jefferies London Healthcare Conference 2024. To schedule a meeting, please contact Jessica Breu, Vice President Investor Relations and Communications, at: [email protected]. November 21: Virtual Investor Summit. Daniel Vitt, Ph.D., Chief Executive Officer of Immunic, will present a company overview on Thursday, November 21, 2024 and participate in one-on-one investor meetings at this conference. To listen to the company presentation, register for the conference using this link. The presentation and presentation time will be accessible on the "Events and Presentations" section of Immunic's website at: , once they are available. 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, 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 management's and employee's participation in industry, scientific and investor conferences. 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, including the ability to satisfy the minimum average price and trading volume conditions required to receive funding in tranche 2 and 3 of the January 2024 private placement, 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. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

: SP-624 may treat depression in women by modulating the distinct female genetic profile. Credit: Prathankarnpap/Shutterstock Arrivo BioVentures’ SIRT6 activator SP-624 has been found to significantly reduce symptoms of major depressive disorder (MDD), but only in women. Steve Butts, Arrivo CEO, stated that data from a Phase IIa trial (NCT04479852) showed SP-624 elicited a significant reduction in MDD symptoms, as measured by the Montgomery-Asberg Depression Rating Scale (MADRS) score. However, reduction was only evident among female patients; for males, no statistically significant difference could be found. Following this trial, the Morrisville, North Carolina-based biotech announced it enrolled its first subject in a Phase I trial (NCT06570369) of the drug for this indication in a 10 October 2024 release. In parallel, Arrivo is running a Phase IIb trial (NCT06254612) specifically focussed on evaluating the drug’s efficacy in female patients as the primary endpoint, which dosed the first patient in April 2024. To explain the disparity, Butts pointed to  research indicating gene expression profiles associated with MDD differ between the sexes. A 2018 meta-analysis published in Biological Psychiatry found that of 706 and 882 genes differentially expressed in men and women with MDD, respectively, only 21 genes in common changed in the same direction—were either up- or downregulated for both sexes. “Our drug is the first epigenetic mechanism being tested in depression that can really test that theory”, claims Butts, adding, “this is the first time that a SIRT6 activator has ever been used in a patient with depression.” See Also: Novartis’ Scemblix gains FDA approval for leukaemia GSK to acquire Chimagen’s CMG1A46 for autoimmune disease SP-624 is a small molecule developed by Sirtsei Pharmaceuticals, a subsidiary of Arrivo, which targets Sirtuin 6 (SIRT6). An NAD-dependent enzyme, SIRT6 modulates gene expression, metabolism, and repair associated with MDD, the activation of which is thought to alleviate depression. Beyond mechanistic differences, MDD also presents at different incidence rates between sexes. As per GlobalData analysis , the prevalence of MDD among females was double that of men in  across the eight major markets (the US, France, Germany, Italy, Spain, the UK, Japan and Canada) 2023. The MDD market is expected to become $9.6bn in size in 2029 in those same eight markets, as per a GlobalData report. GlobalData is the parent company of Pharmaceutical Technology There are so far no marketed therapies indicated exclusively to treat MDD in women, despite its prevalence and distinct genetic profile, and development in the female-oriented clinical space has met resistance. However, in recent years, drugs like Johnson and & Johnson Innovation Medicines’ (J&J) Spravato (esketamine) and Axsome Therapeutics’ Auvelity (dextromethorphan-bupropion) have been approved to treat MDD. J&J also saw some success in the MDD arena earlier this year when its Phase III study with seltorexant improved depressive symptoms in patients as per the MADRS scale. However, not all have been successful. Sage Therapeutics axed 40% of its staff in September 2023 following the rejection of their drug Zurzuvae (zuranolone) for MDD by the US Food and Drug Administration (FDA). The drug is approved to treat postpartum depression (PPD). Earlier this month (17 October 2024), the company fired 55% of the remaining R&D staff to support the drug’s ongoing launch for PPD.