IMMUNIC THERAPEUTICS Immunic Therapeutics Developing Selective Oral Drugs in Immunology NASDAQ: IMUX | March 2021 Cautionary Note Regarding Forward-Looking Statements This presentation contains "forward-looking statements" that involve substantial risks and uncertainties for purposes of the safe harbor within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These include statements regarding management's intentions, pla ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2020 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-36201 Immunic, Inc. (Exact name of registrant as specified in its charter) Delaware 56-2358443 (State or other jurisdiction of incor ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2020 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-36201 Immunic, Inc. (Exact name of registrant as specified in its charter) Delaware 56-2358443 (State or other jurisdiction ...

IMMUNIC THERAPEUTICS Immunic Therapeutics Developing Selective Oral Drugs in Immunology NASDAQ: IMUX | October 2020 Cautionary Note Regarding Forward-Looking Statements This presentation contains "forward-looking statements" that involve substantial risks and uncertainties for purposes of the safe harbor within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These include statements regarding management's intentions, p ...

Financial Data and Key Metrics Changes - Immunic reported positive top-line data from the Phase 2 EMPhASIS trial of IMU-838 for relapsing-remitting multiple sclerosis, indicating a significant clinical advancement for the company [6][10] - The primary endpoint analysis showed that treatment with 45 mg of IMU-838 suppressed an average of 62% of cumulative unique active (CUA) MRI lesions compared to placebo, with a p-value of 0.0002 [21] - The 30 mg dose of IMU-838 demonstrated a 70% suppression of CUA MRI lesions over 24 weeks compared to placebo, with a p-value of less than 0.0001 [22] Business Line Data and Key Metrics Changes - IMU-838 is currently being tested in multiple clinical trials, including those for ulcerative colitis and COVID-19, showcasing its broad therapeutic potential [11] - The trial included a total of 209 patients, with 197 completing the 24-week blinded treatment period, indicating strong patient retention [18] Market Data and Key Metrics Changes - The global market for multiple sclerosis treatments was approximately $22 billion in 2016, with a significant need for effective oral therapies [13] - The company aims to address the unmet medical need for oral medications that balance safety, tolerability, and convenience for MS patients [14] Company Strategy and Development Direction - Immunic is focusing on developing IMU-838 as a once-daily oral medication for relapsing-remitting MS, emphasizing its favorable safety profile and potential for high patient compliance [14][42] - The company is preparing for a potential Phase 3 program based on the positive Phase 2 data, with plans to engage with regulatory authorities for guidance [41][90] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the compelling clinical activity of IMU-838 and its unique safety properties compared to current treatment options [42] - The company is accelerating preparations for Phase 3 testing, indicating confidence in the drug's potential [41] Other Important Information - The trial reported low rates of treatment-emergent adverse events, with only three serious adverse events noted, highlighting the favorable safety profile of IMU-838 [28][39] - No signals for hepatotoxicity were observed in the IMU-838 development program, differentiating it from other MS treatments [32][39] Q&A Session Summary Question: Expected relapse data with two years of treatment based on 24-week results - Management anticipates a more than 30% relapse reduction rate based on the correlation from meta-analysis, pending confirmation in a larger Phase 3 program [46] Question: Initial thoughts on Phase 3 program design - The company plans to follow regulatory guidance and may include a head-to-head trial with an active comparator [49][50] Question: Additional data expected at the September presentation - More detailed safety data and potential signals on EDSS disability progression and brain atrophy data are anticipated [51] Question: Incidence of diarrhea and alopecia rates in the trial - Initial monitoring indicates extremely low incidence rates for these adverse events, with no significant safety concerns expected [56] Question: PML risk with Aubagio and its relevance to IMU-838 - Current understanding suggests that teriflunomide (Aubagio) carries low PML risk, and similar expectations are held for IMU-838 based on its antiviral properties [60] Question: Typical MS patient population in clinical trials - The patient population reflects a shift towards regions with fewer medical resources, which is common in MS clinical trials [61] Question: Effects on total lesion or MRI activity if assessed at 36 weeks - Management believes that longer durations may help with data variability but does not expect a significant change in lesion suppression proportions [66] Question: Additional data needed to prevent a potential black box warning - More patient data showing no acute liver failure cases would be beneficial to alleviate regulatory concerns [68] Question: Curve separation in the study - Separation of treatment arms versus placebo was observed as early as week 6, consistent with other drugs in the category [77] Question: Decision on which dose to carry forward into Phase 3 - No final decision has been made yet, but both doses showed equal efficacy and safety [79] Question: Potential comparators for Phase 3 trials - Comparators will likely include established oral options, but specific details are not yet available [80] Question: Plans for Phase 3 development with potential partners - The company is open to various options, including partnerships, based on the positive data [82] Question: Efficacy at 12 weeks and consistency with previous data - A numerical difference between treatment arms was observed at 12 weeks, but formal statistical analysis was not conducted [100]

Commission File Number: 001-36201 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2020 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Immunic, Inc. (Exact name of registrant as specified in its charter) Delaware 56-2358443 (State or other jurisdiction of i ...

Immunic Therapeutics Developing Selective Oral Drugs in Immunology NASDAQ: IMUX | June 2020 Cautionary Note Regarding Forward-Looking Statements Certain statements contained in this presentation regarding matters that are not historical facts are forward-looking statements within the meaning of Section 21E of the Securities and Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995, known as the PSLRA. These include statements regarding management's intentions, plans, bel ...

[PART I - FINANCIAL INFORMATION](index=4&type=section&id=PART%20I%20-%20FINANCIAL%20INFORMATION) [Item 1. Condensed Consolidated Financial Statements (Unaudited)](index=4&type=section&id=Item%201.%20Condensed%20Consolidated%20Financial%20Statements%20(Unaudited)) For the three months ended March 31, 2020, Immunic, Inc. reported a net loss of $8.5 million, an increase from a $4.3 million loss in the prior-year period, driven by higher research and development and general administrative expenses [Condensed Consolidated Balance Sheets](index=4&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) As of March 31, 2020, the company's total assets were $57.3 million, a decrease from $66.0 million at December 31, 2019, primarily due to a reduction in cash and cash equivalents from $29.4 million to $18.6 million Condensed Consolidated Balance Sheet Highlights (in thousands) | Account | March 31, 2020 (Unaudited) | December 31, 2019 | | :--- | :--- | :--- | | Cash and cash equivalents | $18,578 | $29,369 | | Total current assets | $23,599 | $32,230 | | Total assets | $57,292 | $65,955 | | Total current liabilities | $6,333 | $7,072 | | Total liabilities | $6,804 | $7,592 | | Accumulated deficit | $(68,398) | $(59,911) | | Total stockholders' equity | $50,488 | $58,363 | [Condensed Consolidated Statements of Operations](index=5&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) For the first quarter of 2020, the company reported a net loss of $8.5 million, or ($0.79) per share, compared to a net loss of $4.3 million, or ($5.09) per share, for the same period in 2019 Condensed Consolidated Statements of Operations (in thousands, except per share data) | Metric | Three Months Ended March 31, 2020 | Three Months Ended March 31, 2019 | | :--- | :--- | :--- | | Research and development | $6,434 | $3,355 | | General and administrative | $2,580 | $1,307 | | Total operating expenses | $9,014 | $4,662 | | Loss from operations | $(9,014) | $(4,662) | | Net loss | $(8,487) | $(4,313) | | Net loss per share, basic and diluted | $(0.79) | $(5.09) | [Condensed Consolidated Statements of Cash Flows](index=8&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Net cash used in operating activities for the first quarter of 2020 was $11.0 million, a significant increase from $5.3 million in the prior-year period, reflecting higher operating losses Summary of Cash Flows (in thousands) | Activity | Three Months Ended March 31, 2020 | Three Months Ended March 31, 2019 | | :--- | :--- | :--- | | Net cash used in operating activities | $(11,029) | $(5,317) | | Net cash used in investing activities | $(4) | $(7) | | Net cash provided by financing activities | $568 | $20,531 | | Net change in cash | $(10,791) | $14,947 | [Notes to Condensed Consolidated Financial Statements](index=9&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) The notes detail the company's business as a clinical-stage biopharmaceutical firm with three main product candidates (IMU-838, IMU-935, IMU-856) and key events including a reverse acquisition, an option exercise, and subsequent equity financings and a COVID-19 development program - The company is a clinical-stage biopharmaceutical company developing three small molecule products: IMU-838 (DHODH inhibitor), IMU-935 (RORγt inverse agonist), and IMU-856 (intestinal barrier function restorer)[27](index=27&type=chunk) - The company exercised its option with Daiichi Sankyo on January 5, 2020, to obtain exclusive worldwide commercialization rights for IMU-856, paying a one-time upfront licensing fee[59](index=59&type=chunk)[160](index=160&type=chunk) - In April 2020, the company raised approximately **$13.9 million** in net proceeds from a registered direct offering and an additional **$2.3 million** from its ATM facility[133](index=133&type=chunk)[134](index=134&type=chunk) - In April 2020, the company announced plans for a Phase 2 clinical trial of IMU-838 in COVID-19 patients after it demonstrated preclinical activity against SARS-CoV-2[135](index=135&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=27&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses the increase in operating expenses for Q1 2020, attributing it to the advancement of its clinical programs, particularly the Phase 2 trials for IMU-838 and the initiation of a Phase 1 trial for IMU-935 [Results of Operations](index=31&type=section&id=Results%20of%20Operations) Comparing Q1 2020 to Q1 2019, R&D expenses increased by $3.1 million (92%) due to advancing Phase 2 trials for IMU-838, costs related to IMU-856, and the start of the Phase 1 trial for IMU-935 Operating Expense Comparison (in thousands) | Expense Category | Q1 2020 | Q1 2019 | Change ($) | Change (%) | | :--- | :--- | :--- | :--- | :--- | | Research and development | $6,434 | $3,355 | $3,079 | 92% | | General and administrative | $2,580 | $1,307 | $1,273 | 97% | | **Total operating expenses** | **$9,014** | **$4,662** | **$4,352** | **93%** | - The increase in R&D expenses was driven by a **$1.3 million** increase for IMU-838 Phase 2 trials, **$1.0 million** for IMU-856 license fees and preclinical costs, and **$0.3 million** for the IMU-935 Phase 1 trial[172](index=172&type=chunk) - The increase in G&A expenses was primarily due to a **$0.7 million** increase in personnel expenses and a **$0.3 million** increase in insurance and facility costs after becoming a public company and expanding in the U.S[173](index=173&type=chunk) [Liquidity and Capital Resources](index=33&type=section&id=Liquidity%20and%20Capital%20Resources) The company ended Q1 2020 with $18.6 million in cash and cash equivalents, and with additional equity offerings in April 2020, management expects to fund operations for more than twelve months - As of March 31, 2020, the company had cash and cash equivalents of approximately **$18.6 million**[177](index=177&type=chunk)[184](index=184&type=chunk) - From inception through April 27, 2020, the company has raised net cash of approximately **$89.1 million** from private and public offerings[177](index=177&type=chunk) - The company expects its current cash, including proceeds from April 2020 financings, to fund operations beyond twelve months from the report's issuance date[177](index=177&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=38&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company's primary market risks are interest rate sensitivity and foreign currency exchange risk, with a significant portion of cash held in German bank accounts subject to negative interest rates and exposure to euro fluctuations - The company is exposed to interest rate risk, with **$9.2 million** of its cash held in German bank accounts earning negative interest of **0.5%** as of March 31, 2020[197](index=197&type=chunk) - The company is exposed to foreign currency risk, primarily from the euro, as its main R&D operations are in Germany; a hypothetical **10%** adverse change in exchange rates would have resulted in a **$1.1 million** decrease in net current assets as of March 31, 2020[198](index=198&type=chunk)[200](index=200&type=chunk) [Item 4. Controls and Procedures](index=39&type=section&id=Item%204.%20Controls%20and%20Procedures) Management, including the CEO and Principal Financial Officer, evaluated the company's disclosure controls and procedures and concluded they were effective as of March 31, 2020, with no material changes to internal control over financial reporting during the quarter - The Chief Executive Officer and Principal Financial Officer concluded that the company's disclosure controls and procedures are effective[202](index=202&type=chunk) - There were no changes in internal control over financial reporting during the quarter that materially affected, or are reasonably likely to materially affect, internal controls[203](index=203&type=chunk) [PART II - OTHER INFORMATION](index=39&type=section&id=PART%20II%20-%20OTHER%20INFORMATION) [Item 1. Legal Proceedings](index=39&type=section&id=Item%201.%20Legal%20Proceedings) The company is not currently a party to any material litigation and is not aware of any pending or threatened litigation that would materially affect its business - The company is not currently a party to any litigation, nor is it aware of any pending or threatened litigation, that it believes would materially affect its business[204](index=204&type=chunk) [Item 1A. Risk Factors](index=39&type=section&id=Item%201A.%20Risk%20Factors) The company has identified new risk factors related to the COVID-19 pandemic, including the inherent uncertainty and resource diversion of pursuing a COVID-19 drug candidate, and potential interruptions or delays to ongoing clinical trials for its other product candidates - A new risk factor highlights that the pursuit of a COVID-19 drug candidate is at an early stage and may not be successful, while committing financial and personnel resources could negatively impact other development programs[206](index=206&type=chunk)[208](index=208&type=chunk) - The COVID-19 pandemic may cause interruptions or delays in clinical trials, including for IMU-838, due to hospitals shifting resources, patient enrollment difficulties, and potential clinical site closures[210](index=210&type=chunk) - The pandemic could have a material adverse effect on business operations, including supply chain disruptions, hampering the ability to raise funds, and a general slowdown of the global economy[211](index=211&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=41&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) The company reported no sales of unregistered securities during the three months ended March 31, 2020 - During the three months ended March 31, 2020, we did not have any sales of unregistered securities[212](index=212&type=chunk) [Item 3. Defaults Upon Senior Securities](index=41&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) Not applicable [Item 4. Mine Safety Disclosures](index=42&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) Not applicable [Item 5. Other Information](index=42&type=section&id=Item%205.%20Other%20Information) None [Item 6. Exhibits](index=43&type=section&id=Item%206.%20Exhibits) This section lists the exhibits filed with the Form 10-Q, including corporate governance documents, material agreements, and certifications required by the Sarbanes-Oxley Act

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2019 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-36201 Immunic, Inc. (Exact name of registrant as specified in its charter) Delaware 56-2358443 (State or other jurisdiction of incor ...

Company Overview - Immunic Therapeutics is developing oral therapies for chronic inflammatory and autoimmune diseases [1, 5] - The company's cash position was $305 million as of September 30, 2019, expected to last into Q1 2021 [8] - Immunic completed a reverse takeover with Vital Therapies, supported by a committed investor base investing approximately $30 million in April 2019 [62] IMU-838 (DHODH Inhibitor) - IMU-838 is currently being tested in three Phase 2 studies [8, 63] - A Phase 2 trial in RRMS enrolled 210 patients across 36 centers in Europe, with top-line data expected in Q3 2020 [23] - Aubagio, another DHODH inhibitor for MS, reached sales of around $18 billion in 2018 [17] - In an investigator-sponsored trial (ENTRANCE) using IMU-838 active moiety, 885% of patients had a total response [33] - The global market for IBD in 2023 is estimated to be approximately $76 billion [67] IMU-935 (Oral IL-17 Inhibitor) - Phase 1 of IMU-935 started in September 2019, with initial data expected in Q1 2020 [63] - IMU-935 inhibits cytokines in the low nanomolar range, with IC50 values of 0005 µM for IL-17A, 0004 µM for IL-17F, and 0003 µM for IFNg [53] IMU-856 (Intestinal Barrier Function) - IMU-856 could be a disruptive technology for treating GI diseases like IBS-D and IBD by restoring intestinal barrier function [63] - Phase 1 single and multiple ascending dose studies for IMU-856 are expected to start in H1 2020 [60]