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NEW YORK, April 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 that it will host a Multiple Sclerosis (MS) Research and Development (R&D) Day and participate in the following investor conferences in April: April 9: Immunic's MS R&D Day . Management of Immunic, including Daniel Vitt, Ph.D., Chief Executive Officer and President, Andreas Muehler, M.D., M.B.A. Chief Medical Officer and Hella Kohlhof, Ph.D, Chief Scientific Officer, will be joined by renowned key opinion leaders to discuss the latest developments in the MS landscape as well as recent preclinical and clinical data supporting the neuroprotective potential of Immunic's late-stage clinical asset, first-in-class Nurr1 activator, vidofludimus calcium. The MS R&D Day will take place on Tuesday, April 9, 2024, from 10:30 am to 12:30 pm PST in-person at the Hotel Nikko in San Francisco. To register, please RSVP by sending an email to: [email protected]. April 15-17: Accelerating Bio-Innovation 2024 UK. Dr. Vitt will participate in one-on-one meetings at this conference in Cambridge, England. April 17-18: Noble Capital Markets Emerging Growth Virtual Healthcare Equity Conference. Dr. Vitt will participate in a fireside chat and one-on-one investor meetings at this virtual conference. A webcast of the presentation will be available on the "Events and Presentations" section of Immunic's website at: . An archived replay will be available after the conference. 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 corporate events 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, 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 KOGS Communication Edna Kaplan +1 617 974 8659 [email protected] SOURCE Immunic, Inc.

NEW YORK, April 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 that it will host a Multiple Sclerosis (MS) Research and Development (R&D) Day and participate in the following investor conferences in April: April 9: Immunic's MS R&D Day. Management of Immunic, including Daniel Vitt, Ph.D., Chief Executive Officer and President, Andreas Muehler, M.D., M.B.A. Chief Medical Officer and Hella Kohlhof, Ph.D, Chief Scientific Officer, will be joined by renowned key opinion leaders to discuss the latest developments in the MS landscape as well as recent preclinical and clinical data supporting the neuroprotective potential of Immunic's late-stage clinical asset, first-in-class Nurr1 activator, vidofludimus calcium. The MS R&D Day will take place on Tuesday, April 9, 2024, from 10:30 am to 12:30 pm PST in-person at the Hotel Nikko in San Francisco. To register, please RSVP by sending an email to: ir@imux.com. April 15-17: Accelerating Bio-Innovation 2024 UK. Dr. Vitt will participate in one-on-one meetings at this conference in Cambridge, England. April 17-18: Noble Capital Markets Emerging Growth Virtual Healthcare Equity Conference. Dr. Vitt will participate in a fireside chat and one-on-one investor meetings at this virtual conference. A webcast of the presentation will be available on the "Events and Presentations" section of Immunic's website at: . An archived replay will be available after the conference. 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 corporate events 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, 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 jessica.breu@imux.com US IR Contact Rx Communications Group Paula Schwartz +1 917 633 7790 immunic@rxir.com US Media Contact KOGS Communication Edna Kaplan +1 617 974 8659 kaplan@kogspr.com View original content to download multimedia: SOURCE Immunic, Inc. Company Codes: NASDAQ-NMS:IMUX

Full-year 2023 net revenue reaches 135 billion KRW, driven by strong sales growth. R&D momentum persisted with promising developments in anti-FcRn antibodies HL161ANS and batoclimab, positioning them as potentially best-in-class treatments for lgG-mediated autoimmune diseases. Anticipates the initiation of tanfanercept Phase 3 VELOS-4 study in dry eye disease in the first half of 2024 and top-line data results from HL192 Phase 1 study for Parkinson's Disease in the second half of 2024. ROCKVILLE, Md. and SEOUL, South Korea, March 21, 2024 /PRNewswire/ -- HanAll Biopharma Co., Ltd. (KRX: 009420.KS), a global biopharmaceutical company committed to discovering and developing innovative medicines for patients, reported financial results for 2023 and provided business updates. HanAll delivered a strong full-year performance, with a 23 percent increase in sales compared to 2022, demonstrating continued innovation momentum through multiple meaningful data readouts for anti-FcRn assets and the dry eye disease program. Total revenues for 2023 were 135 billion Korean won (KRW), mainly driven by strong sales growth from key products. Operating income for the year recorded 2.2 billion KRW. "2023 marked a significant milestone as we celebrated our 50th anniversary. We have delivered record-high sales performance, with continued advancements in our R&D programs by adding the Parkinson's disease program, completing the VELOS-3 study in dry eye, and securing meaningful outcomes from the Phase 1 study of HL161ANS, our second anti-FcRn asset," said Sean Jeong, M.D., MBA, CEO of HanAll Biopharma. "As we anticipate further advancements in 2024, including the VELOS-4 study in dry eye and additional data readouts from the anti-FcRn assets and Parkinson's program, we will continue to focus our efforts to serve patients," he added. Full-Year 2023 BUSINESS UPDATE Pipeline Development Highlights A comprehensive update of HanAll's pipeline development below includes an overview of research along with lists of compounds, targeted indications, and developmental phases. AUTOIMMUNE DISEASES PROGRAMS Batoclimab (HL161BKN) A novel, fully human, subcutaneously administered antibody targeting FcRn with the potential to address multiple IgG-mediated autoimmune diseases. Batoclimab is designed to selectively bind to FcRn, which plays a role in recycling IgG, thereby reducing levels of harmful IgG antibodies. Immunovant, HanAll's licensed partner in the United States and Europe, has reported positive initial results from a Phase 2 proof-of-concept trial evaluating the safety and efficacy of batoclimab in patients with Graves' disease. The study demonstrated that batoclimab achieved response rates exceeding 50% in patients who are hyperthyroid despite treatment with an anti-thyroid medication (ATD) for more than 12 weeks. Treatment response is defined as normalization of T3 and T4 hormone levels without increasing ATD dose. Consistent with studies of batoclimab in other indications, the subcutaneous administration of 680 mg batoclimab showed an impressive reduction of up to 87% in IgG levels, with a mean IgG reduction of 81% after 12 weeks of treatment. Batoclimab was generally well tolerated with no new safety signals identified from the initial data set. Immunovant plans to assess the development of the second anti-FcRn, 'HL161ANS (IMVT-1402)', for Graves' disease, with details expected to be unveiled later in 2024. Harbour BioMed, a licensed partner in China, provided updates on the progress of the Biologics License Application (BLA) submission for batoclimab, intended for the treatment of generalized myasthenia gravis (gMG). In line with the clinical study protocol, the company is currently in the extension period of the Phase 3 clinical trial to gather additional long-term safety data. Harbour BioMed plans to include the supplementary long-term safety data and aims to re-submit the BLA for batoclimab to the National Medical Products Administration (NMPA) in the first half of 2024. BLA submission for batoclimab for the treatment of gMG was made in June 2023, prompted by a positive topline result obtained from the Phase 3 clinical trial. HanAll and Immunovant are progressing a Phase 3 clinical study of batoclimab in generalized myasthenia gravis (gMG) in Japan. Clinical trial notification (CTN) was approved to initiate a Phase 3 clinical study of batoclimab in thyroid eye disease (TED) in Japan. HL161ANS Another novel, fully human, subcutaneous antibody molecule that inhibits FcRn-mediated recycling of IgG is designed to deliver maximum lgG reductions while minimizing interference with albumin recycling. Immunovant announced positive initial Phase 1 600 mg MAD results for HL161ANS (IMVT-1402) in November 2023. In the study, four once-weekly subcutaneous injections of 600 mg HL161ANS reduced total IgG level by a mean of 74%, demonstrating comparable potency to batoclimab 680 mg, which reduced IgG by 76% after four weekly doses. Overall, HL161ANS consistently demonstrated a significant reduction in IgG levels with potency similar to or greater than that of batoclimab, with no significant decrease in serum albumin or significant increase in LDL-cholesterol levels at day 29 (peak pharmacodynamics impact) from baseline (p-values > 0.05). OPHTHALMIC DISEASE PROGRAM Tanfanercept (HL036) A novel topical protein therapy for ophthalmic diseases, including dry eye disease (DED), which inhibits TNF, a key mediator of ocular inflammation HanAll Biopharma and Daewoong Pharmaceutical successfully concluded discussions with the FDA in the second half of 2023, finalizing the Phase 3 VELOS-4 study design and development plan. The anticipated initiation of the VELOS-4 study is set for the first half of 2024. The concluded Phase 3 VELOS-3 study revealed a significant improvement in the unanesthetized Schirmer test, a secondary efficacy endpoint measuring changes in tear volume from baseline in individuals treated with tanfanercept 0.25% compared to the vehicle. This improvement, assessed at week 8, demonstrated a highly statistically significant outcome (p=0.002). Furthermore, a noteworthy proportion of participants in the tanfanercept group (13%) exhibited a Schirmer test improvement of at least 10 mm from baseline at week 8, which was statistically significant (p=0.011) compared to the vehicle group (4%). It is worth mentioning that, according to the FDA's 2020 Draft Guidance on Dry Eye Drug Development, achieving a statistically significant difference in the percentage of patients with a minimum 10 mm increase in the Schirmer test is considered an acceptable primary efficacy endpoint. The FDA has also outlined an alternative approval pathway, requiring the demonstration of a statistically significant difference in an objective predefined sign of dry eye and, additionally, at least one subjective predefined symptom of dry eye. However, this second pathway often involves increased complexity, necessitating additional studies. NEUROLOGY PROGRAM HL192 (ATH-399A) A pipeline candidate originated from NurrOn Pharmaceuticals that targets Nurr1, a master regulator in dopaminergic neuron development and maintenance, is being developed to treat neurodegenerative diseases, including Parkinson's disease (PD). HanAll Biopharma, Daewoong Pharmaceutical, and NurrOn Pharmaceuticals are progressing with the Phase 1 clinical trial of HL192 in healthy participants. The results from the Phase 1 clinical trial of HL192 are expected in the second half of 2024. ONCOLOGY PROGRAMS HL187/ HL186 HL187 is a monoclonal antibody that targets TIGIT (T cell immunoreceptors with Ig and ITIM domains {Immunoreceptor tyrosine-based inhibitory motif domains}). HL186 is a monoclonal antibody that targets TIM-3 (T cell Ig and mucin domain-3). These antibodies are being developed in collaboration with Daewoong Pharmaceutical as potential oncology treatments. HanAll is currently advancing the pre-clinical examination of HL187 (anti-TIGIT) and concurrently evaluating the prospects of HL186 (anti-TIM-3) as part of the ongoing strategic portfolio review. FINANCIAL HIGHLIGHTS (CONSOLIDATED) Key Highlights Sales generated 135 billion KRW in 2023, a 22.7% increase compared to 2022. Sales remained strong with its major products including Normix, Eligard, and Biotop. R&D expenses, reported as 24 billion KRW, a 45.1% increase compared to 2022. Operating income was 2.2 billion KRW, a 46.9% increase compared to the same period in 2022. Net income was 3.5 billion KRW, compared to 300 million KRW in 2022. About HanAll Biopharma HanAll Biopharma (KRX: 009420.KS) is a global biopharmaceutical company with a presence in Korea, the USA, Japan, and Indonesia with a mission of making meaningful contributions to patients' lives by introducing innovative, impactful medicines to address severe unmet medical needs. HanAll has been operating a portfolio of pharmaceutical products in the areas of endocrine, circulatory, and urologic diseases for over 50 years. HanAll has also expanded its focus to immunology, oncology, neurology, and ophthalmology to discover and develop innovative medicines for patients with diseases for which there are no effective treatments. Its lead pipeline asset, HL161 (INN: batoclimab), an anti-FcRn antibody, is being developed in Phase 3 and Phase 2 trials across the world for the treatment of autoimmune diseases including myasthenia gravis (MG), thyroid eye disease (TED), chronic inflammatory demyelinating polyneuropathy (CIDP), and Graves' disease (GD). Another main asset, HL036 (INN: tanfanercept), a TNF inhibitor protein, is being evaluated in Phase 3 clinical studies in the US and China for the treatment of dry eye disease. For further information, visit our website and connect with us on LinkedIn. For any media inquiries, please contact HanAll PR/IR ([email protected], [email protected]). Disclaimer Statement The contents of this announcement include statements that are, or may be deemed to be, "forward-looking statements." These forward-looking statements can be identified by the use of forward-looking terminology, including the terms "believes," "estimates," "anticipates," "expects," "intends," "may," "will," or "should," and include statements HANALL (the company, we) makes concerning its 2024 business and financial outlook and related plans; the therapeutic potential of its product candidates; the intended results of its strategy and the company, and its collaboration partners', advancement of, and anticipated clinical development, data readouts and regulatory milestones and plans, including the timing of planned clinical trials and expected data readouts; the design of future clinical trials and the timing and outcome of regulatory filings and regulatory approvals. By their nature, forward-looking statements involve risks and uncertainties, and readers are cautioned that any such forward-looking statements are not guarantees of future performance. The company's actual results may differ materially from those predicted by the forward-looking statements. These may include various significant factors, such as our expectations regarding the inherent uncertainties associated with competitive developments, preclinical and clinical trial and product development activities, and regulatory approval requirements. In addition, performance may be affected by our reliance on collaborations with third parties, estimating the commercial potential of our product candidates, our ability to obtain and maintain protection of intellectual property of technologies and drugs, our limited operating history, and our ability to obtain additional funding for operations and to complete the development and commercialization of product candidates. A further list and description of these risks, uncertainties, and other risks can be found in Korea Stock Exchange (KRX) filings and reports, including in our most recent annual report as well as subsequent filings and reports filed by the company with the KRX. Given these uncertainties, the reader is advised not to place any undue reliance on such forward-looking statements. These forward-looking statements speak only as of the date of publication of this document. We undertake no obligation to publicly update or revise the information in this press release, including any forward-looking statements, except as may be required by Korean law and regulations. SOURCE HanAll Biopharma