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 ...

Immunic, Inc. (NASDAQ:IMUX) Q4 2022 Earnings Conference Call February 23, 2023 8:00 AM ET Company Participants Jessica Breu - Head, IR & Communications Daniel Vitt - CEO, President & Director Glenn Whaley - CFO Conference Call Participants Yasmeen Rahimi - Piper Sandler & Co. Matthew Kaplan - Ladenburg Thalmann & Co. Andreas Argyrides - Wedbush Securities William Wood - B. Riley Securities Jessica Breu Good morning and welcome to Immunic's Fourth Quarter and Year End 2022 Earnings Call. My name is Jessica B ...

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, 2022 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 ...

Immunic, Inc. (NASDAQ:IMUX) Q3 2022 Earnings Conference Call November 3, 2022 8:00 AM ET Company Participants Jessica Breu - Head, IR and Communications Daniel Vitt - CEO and President Glenn Whaley - CFO Andreas Muehler - Chief Medical Officer Conference Call Participants Andreas Argyrides - Wedbush Yasmeen Rahimi - Piper Sandler Matt Kaplan - Ladenburg Operator Jessica Breu Good morning, everyone, and welcome to Immunic's Third Quarter 2022 Earnings Call. My name is Jessica Breu, Head of Investor Relations ...

Immunic, Inc. (NASDAQ:IMUX) Q2 2022 Earnings Conference Call August 4, 2022 8:00 AM ET Company Participants Jessica Breu - Head, Investor Relations and Communications Daniel Vitt - Chief Executive Officer and President Glenn Whaley - Chief Financial Officer Hella Kohlhof - Chief Scientific Officer Conference Call Participants Andreas Argyrides - Wedbush Yasmeen Rahimi - Piper Sandler Matt Kaplan - Ladenburg Michael Kratky - SVB Securities Jessica Breu Good morning, everybody and welcome to Immunic’s Second ...

lmmunic THERAPEUTICS Immunic Therapeutics Second Quarter 2022 Financial Results and Corporate Update NASDAQ: IMUX | August 4, 2022 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' ...

IMMUNIC THERAPEUTICS Immunic Therapeutics First Quarter 2022 Financial Results and Corporate Update NASDAQ: IMUX | May 10, 2022 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 i ...

Immunic Inc. (NASDAQ:IMUX) Q1 2022 Earnings Conference Call May 10, 2022 8:00 AM ET Company Participants Daniel Vitt – Chief Executive officer, President & Director Glenn Whaley – Vice President of Finance and Principal Financial & Accounting Officer Conference Call Participants Thomas Smith – SVB Leerink Yasmeen Rahimi – Piper Sandler Andreas Argyrides – Wedbush Matthew Kaplan – Lautenbach Tallmann Boobalan Pachaiyappan – H.C. Wainwright Zegbeh Jallah – Roth Capital Operator Good morning and welcome to Imm ...

Immunic inc. (NASDAQ:IMUX) Q4 2021 Earnings Conference Call February 24, 2021 8:00 AM ET Company Participants Daniel Vitt – Chief Executive officer, President & Director Glenn Whaley – VP of Finance and Principal Financial & Accounting Officer Andreas Muehler – Chief Medical Officer Conference Call Participants Jessica Vo – Piper Sandler Andreas Argyrides – Wedbush Gobind Singh – JMP Matt Kaplan – lender Zegbeh Jallah – Roth Capital Boobalan Pachaiyappan – H.C. Wainwright Matt Price – SVP Operator Good mor ...