– Substantially Bolstered Balance Sheet Through a Three-Tranche Private Placement Totaling Up to $240 Million, Extending Cash Runway Into the Third Quarter of 2025, Based on Initial $80 Million Tranche – – Received Fourth U.S. Patent Directed to Use of Vidofludimus Calcium in Multiple Sclerosis; Multilayered Intellectual Property Strategy Provides Protection Into 2041 in the United States – – Twin Phase 3 ENSURE Trials in Relapsing Multiple Sclerosis and Phase 2 CALLIPER Trial in Progressive Multiple Sclero ...

NEW YORK, May 6, 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 investor and scientific conferences in May: May 12-14 and 21-22: Bio€quity Europe 2024. Jessica Breu, Vice President Investor Relations and Communications at Immunic, will attend and host one-on-one investor meetings at this conference taking ...

– Webcast to be Held at 8:00 am ET on May 8, 2024 –NEW YORK, May 1, 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 first quarter ended March 31, 2024, including a corporate update, on Wednesday, May 8, 2024, before the opening of the U.S. financial markets. A webcast will follo ...

About this content About Emily Jarvie Emily began her career as a political journalist for Australian Community Media in Hobart, Tasmania. After she relocated to Toronto, Canada, she reported on business, legal, and scientific developments in the emerging psychedelics sector before joining Proactive in 2022. She brings a strong journalism background with her work featured in newspapers, magazines, and digital publications across Australia, Europe, and North America, including The Examiner, The Advocate, ...

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, 2023 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 ot ...

Financial Performance - The net loss for the year ended December 31, 2023, was approximately $93.6 million, or $2.11 per share, an improvement from a net loss of $120.4 million, or $3.78 per share, for the same period in 2022[8]. - Total operating expenses decreased to $99,223,000 in 2023 from $119,488,000 in 2022, a reduction of approximately 17%[15]. - Net loss narrowed to $93,612,000 in 2023 compared to a net loss of $120,407,000 in 2022, reflecting an improvement of approximately 22%[15]. - Net loss per share improved to $(2.11) in 2023 from $(3.78) in 2022, indicating a reduction of about 44%[15]. Research and Development - Research and Development (R&D) expenses increased to $83.2 million for the year ended December 31, 2023, compared to $71.2 million in 2022, primarily due to increased external development costs[8]. - Research and development expenses increased to $83,215,000 in 2023, up from $71,255,000 in 2022, representing a growth of about 17%[15]. - The top-line data from the Phase 2 CALLIPER trial of vidofludimus calcium in progressive multiple sclerosis (PMS) is expected in April 2025[8]. - An interim futility analysis for the Phase 3 ENSURE program is anticipated in late 2024, with the first trial read-out expected in Q2 2026[8]. - Positive results from the Phase 1b clinical trial of IMU-856 in celiac disease showed meaningful improvements over placebo in key dimensions of the disease[5]. - The company is preparing for Phase 2 testing of IMU-856 in ongoing active celiac disease patients[8]. Financial Position - Cash, cash equivalents, and investments as of December 31, 2023, were $46.7 million, supplemented by approximately $75.0 million from the first tranche of the private placement[8]. - Cash and cash equivalents decreased to $46,674,000 in 2023 from $106,745,000 in 2022, a decline of approximately 56%[17]. - Total assets decreased to $54,299,000 in 2023 from $127,753,000 in 2022, a reduction of about 57%[17]. - Total liabilities increased to $25,368,000 in 2023 from $14,069,000 in 2022, an increase of approximately 80%[17]. - Stockholders' equity decreased significantly to $28,931,000 in 2023 from $113,684,000 in 2022, a decline of about 75%[17]. - Weighted-average common shares outstanding increased to 44,320,050 in 2023 from 31,819,006 in 2022, an increase of approximately 39%[15]. Private Placement - Immunic executed a three-tranche private placement of up to $240 million, with the first tranche of $80 million completed in January 2024, extending the cash runway into Q3 2025[1][6]. Patent and Exclusivity - The patent portfolio for vidofludimus calcium has been expanded, providing exclusivity protection expected to last until 2041 in the United States[2][4]. Interest Income - Interest income rose to $3,075,000 in 2023 from $1,041,000 in 2022, representing an increase of about 195%[15].

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, 2023 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 ...

Financial Data and Key Metrics Changes - For the three months ended June 30, 2023, the net loss was approximately $24 million or $0.54 per share, compared to a net loss of approximately $21.9 million or $0.72 per share for the same period in 2022, reflecting an increase in loss despite a higher number of shares outstanding [9][70]. - General and administrative expenses were $3.8 million for the three months ended June 30, 2023, down from $4.1 million for the same period in 2022, primarily due to a decrease in non-cash stock compensation [43]. - Research and development expenses increased to $21.2 million for the three months ended June 30, 2023, from $16.5 million for the same period in 2022, driven by ongoing clinical trials [42][68]. Business Line Data and Key Metrics Changes - The Phase Ib data for IMU-856 showed effectiveness in improving key aspects of celiac disease, including gut architecture protection and nutrient absorption, indicating a positive trajectory for this program [4][35]. - The maintenance phase data for vidofludimus calcium in ulcerative colitis demonstrated a statistically significant improvement over placebo, confirming its activity in patients [3][39]. Market Data and Key Metrics Changes - The company reported an increase in other income to $3 million for the six months ended June 30, 2023, compared to a loss of $0.7 million for the same period in 2022, attributed to higher interest income and reduced foreign exchange losses [44]. - The company ended the quarter with $77.3 million in cash, expected to fund operations into the fourth quarter of 2024, indicating a stable financial position [67][87]. Company Strategy and Development Direction - The company is preparing for a Phase II clinical trial of IMU-856 in active celiac disease patients, aiming to establish it as a new oral treatment option for gastrointestinal diseases [12][35]. - The design of the Phase III ENSURE program for vidofludimus calcium is believed to provide a straightforward path to potential regulatory approval in relapsing multiple sclerosis [11][30]. Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the ongoing enrollment for the ENSURE trials, indicating that it is on track compared to planned enrollment [53]. - The company anticipates reporting data from the interim analysis of the Phase II CALLIPER trial in progressive MS in the fall of this year, with further updates expected on the Phase II clinical trial of IMU-856 [30][45]. Other Important Information - The company hosted a virtual expert roundtable on celiac disease, highlighting the unmet medical need for therapeutic solutions in this area [36]. - The company is exploring additional molecules that may benefit from the data obtained from the CALDOSE study, indicating potential for further development in gastrointestinal indications [19]. Q&A Session Summary Question: Can you provide insight into patient enrollment for ENSURE? - Management confirmed that enrollment is progressing well and is on track compared to expectations [53]. Question: What data do you expect to report with the interim biomarker analysis from the CALLIPER trial? - Management stated that they cannot quantify expectations but hope for good differentiation between active and placebo groups [51]. Question: What gives you confidence that the Nurr1 activator would work in progressive forms of multiple sclerosis? - Management noted that existing literature and preliminary data suggest potential efficacy, but clinical studies are needed to confirm this [82].

or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 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, 2023 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 i ...

Financial Data and Key Metrics - The company ended Q1 2023 with $97.1 million in cash and investments, expected to fund operations into Q4 2024 [14] - Net loss for Q1 2023 was approximately $25.3 million, or $0.58 per basic and diluted share, compared to a net loss of $20.8 million, or $0.74 per basic and diluted share, in Q1 2022 [15] - Research and development expenses increased to $23 million in Q1 2023 from $17.4 million in Q1 2022, driven by external development costs for ongoing clinical trials [39] - General and administrative expenses rose slightly to $4.3 million in Q1 2023 from $4 million in Q1 2022, primarily due to increased travel expenses [7] Business Line Data and Key Metrics - IMU-856 demonstrated significant clinical improvements in celiac disease patients, including protection of gut architecture, symptom improvement, biomarker response, and enhanced nutrient absorption [37] - Vidofludimus calcium showed neuroprotective potential in progressive MS, with a low rate of confirmed disability worsening over time [11] - The company is exploring additional clinical applications for IMU-856 in other gastrointestinal disorders, such as Crohn's disease and ulcerative colitis [24][42] Market Data and Key Metrics - The company is preparing for a Phase 2b clinical trial of IMU-856 in active celiac disease patients, following positive Phase 1b results [42] - Interim biomarker analysis data from the CALLIPER trial in progressive MS is expected in H2 2023, with top-line data anticipated by the end of 2024 [16] Company Strategy and Industry Competition - The company believes IMU-856 represents a novel therapeutic approach for gastrointestinal disorders, potentially offering a game-changing treatment option [96] - Vidofludimus calcium is positioned as a unique treatment for multiple sclerosis, combining anti-inflammatory, antiviral, and neuroprotective effects [17] - The company is considering partnerships and business development opportunities for its pipeline programs, particularly for IMU-856 and vidofludimus calcium [80] Management Commentary on Operating Environment and Future Outlook - Management expressed excitement about the potential of IMU-856 and vidofludimus calcium, highlighting their unique mechanisms of action and clinical potential [18][96] - The company remains well-funded, with a strong cash position to support ongoing clinical trials and development milestones [89] Other Important Information - The company announced the addition of a new program, IMU-381, targeting gastrointestinal diseases, with preclinical development underway [76][84] - Dr. Richard Rudick joined the Board of Directors, bringing extensive expertise in multiple sclerosis and clinical trials [95] Q&A Session Summary Question: Confidence in IMU-856's mechanism of action and potential for other indications - Management highlighted preclinical and clinical data supporting IMU-856's efficacy, particularly in celiac disease, and its potential for other gastrointestinal disorders like Crohn's disease and ulcerative colitis [21][24] Question: Timeline for FDA meeting and Phase 2b design for IMU-856 - The company is working on finalizing the Phase 2b trial design and plans to submit an IND filing in the US soon, with discussions with regulators expected to follow [50] Question: Potential for IMU-856 in other GI diseases - Management indicated that while the focus is on celiac disease, Crohn's disease and ulcerative colitis are also promising indications for IMU-856 [62] Question: Interim results from the CALLIPER trial and their impact - The interim analysis will focus on biomarkers (NfL and GFAP levels) to assess treatment benefits in different MS patient subgroups, potentially influencing trial prioritization [67] Question: Follow-up on Phase 1b patients and target novelty of IMU-856 - No follow-up is planned for Phase 1b patients, as the trial was designed for proof-of-concept. The SIRT6 target is novel, with only one other company known to be working on it in a different context [71][72] Question: Business development interest and partnership opportunities - Management noted increased interest in IMU-856 following the celiac disease data and remains open to partnerships, with decisions based on value and strategic fit [79][80]