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 ...

Immunic, Inc. (NASDAQ:IMUX) Q2 2023 Earnings Conference Call August 3, 2023 8:00 AM ET Company Participants Jessica Breu - Head of IR & Communications Daniel Vitt - CEO and President Glenn Whaley - CFO Conference Call Participants Lauren Timmins - Piper Sandler Andreas Argyrides - Wedbush Matt Kaplan - Ladenberg Operator Good morning, and welcome to Immunic's Second Quarter 2023 Earnings Call. My name is Jessica Breu, Head of Investor Relations and Communications at Immunic. I will also be the moderator o ...

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]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Commission File Number: 001-36201 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 March 31, 2023 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 ...