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].

Product Development - Immunic is developing three main product candidates: vidofludimus calcium (IMU-838) for multiple sclerosis, IMU-856 for gastrointestinal diseases, and IMU-381 for gastrointestinal diseases, with ongoing clinical trials for each[119][120][124]. - The Phase 3 ENSURE program for vidofludimus calcium is currently enrolling patients, with interim analysis data expected in late 2024 and top-line data by the end of 2025[120]. - IMU-856 has shown positive results in a Phase 1 clinical trial for celiac disease, demonstrating improvements in gut architecture, patient symptoms, biomarker response, and nutrient absorption[123][131]. - Vidofludimus calcium has been tested in over 1,400 human subjects, showing a consistent pharmacokinetic, safety, and tolerability profile[121]. - Positive data from the maintenance phase of the Phase 2b CALDOSE-1 trial of vidofludimus calcium showed a 33.7% absolute improvement in clinical remission over placebo at week 50, with statistical significance (p=0.0358) for the 30 mg dose[136]. - A dose-linear increase in endoscopic healing was observed, with a 37.8% absolute improvement over placebo for the 30 mg dose, achieving statistical significance (p=0.0259)[136]. - Recent preclinical data indicates that vidofludimus calcium acts as a potent Nurr1 activator, which may enhance its neuroprotective effects in MS[129]. - The company is preparing for a Phase 2 clinical trial of IMU-856 in patients with ongoing active celiac disease[132]. - The company is conducting additional preclinical research to explore antiviral-directed development activities with new antiviral molecules[125]. Financial Performance - Research and development expenses increased by $4.6 million (28%) to $21.2 million for the three months ended June 30, 2023, compared to the same period in 2022[149]. - Total operating expenses for the three months ended June 30, 2023, were $25.0 million, a 21% increase from $20.6 million in the same period in 2022[149]. - The net loss for the three months ended June 30, 2023, was $24.0 million, a 10% increase from $21.9 million in the same period in 2022[149]. - Research and development expenses for the six months ended June 30, 2023, increased by $10.2 million (30%) to $44.1 million compared to the same period in 2022[153]. - The net loss for the six months ended June 30, 2023, was $49.3 million, a 15% increase from $42.7 million in the same period in 2022[153]. - The accumulated deficit reached approximately $366.6 million as of June 30, 2023, up from $317.3 million as of December 31, 2022[157]. - As of June 30, 2023, the company had cash and cash equivalents of approximately $77.3 million, expected to fund operations beyond twelve months[160]. - The company has raised approximately $355.6 million from private and public offerings since inception through June 30, 2023[159]. - During the six months ended June 30, 2023, operating activities used $39.5 million of cash, primarily due to a net loss of $49.3 million[170]. - The company anticipates needing substantial additional funding for ongoing operations, with no committed external source of funds available[168]. Operational Overview - Immunic has approximately 75 employees and is headquartered in New York City, with main operations in Gräfelfing, Germany[118]. - The company is exploring potential strategic collaborations to enhance the commercialization of its product candidates[132]. - Immunic is utilizing its Gräfelfing, Germany location for most R&D activities, aiming for timely and cost-effective execution of development programs[126]. - The company raised gross proceeds of $10.3 million in the three months ended June 30, 2022, through the December 2020 ATM by selling 1,300,000 shares at a weighted average price of $7.90 per share[165]. - As of July 28, 2023, $8.1 million in capacity remains under the December 2020 ATM, and $80.0 million in capacity remains under the May 2022 ATM[162][163]. - The company does not expect to generate any revenue from product sales until regulatory approval is obtained for its product candidates[166]. - The company incurred net cash used in investing activities of $40,000 during the six months ended June 30, 2022, related to the purchase of property and equipment[172]. - The company has non-cancelable contractual obligations totaling approximately $3.4 million related to development programs, expected to be paid in the next twelve months[176]. Currency and Cash Flow - A 10% adverse change in foreign currency exchange rates could result in a decrease of approximately $0.5 million in net current assets as of June 30, 2023[184]. - Net cash provided by financing activities was $147,000 during the six months ended June 30, 2023, primarily from the issuance of common stock[173].

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 ...

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, 2022 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 ...