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-Q (Mark One) Delaware 56-2358443 (State or other jurisdiction of incorporation or organization) (I.R.S. Employer Identification No.) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2024 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 I ...

Immunic, Inc. Reports First Quarter 2024 Financial Results and Provides Corporate Update – 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 ...

– 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].

Financial Position - As of September 30, 2023, Immunic has an accumulated deficit of approximately $389.3 million, up from $317.3 million as of December 31, 2022[131]. - The company has raised net cash of approximately $355.9 million from private and public offerings since inception, with cash and cash equivalents of approximately $59.7 million as of September 30, 2023[133]. - Cash and cash equivalents were approximately $59.7 million, insufficient to fund operations for the next twelve months without raising additional capital[170]. - As of September 30, 2023, total contractual obligations related to operating leases amounted to $1.595 million, with a present value of obligations at $1.451 million[186]. - The company has non-cancelable contractual obligations under development programs totaling approximately $5.1 million, expected to be paid over the next twelve months[186]. - Operating activities used $56.8 million in cash during the nine months ended September 30, 2023, compared to $50.0 million in 2022[180]. - Net cash provided by financing activities was $0.4 million for the nine months ended September 30, 2023, compared to $39.7 million for the same period in 2022[184]. - A hypothetical 10% adverse change in foreign currency exchange rates could decrease net current assets by approximately $1.3 million as of September 30, 2023[193]. - A 10% change in foreign currency exchange rates for the nine months ended September 30, 2023, would have impacted the net loss by approximately $6.3 million, primarily due to the euro[193]. - The company has not entered into any foreign currency hedging transactions or derivative financial transactions to mitigate foreign currency risk[191]. Clinical Development - Vidofludimus calcium (IMU-838) is in Phase 3 clinical development for multiple sclerosis (MS), with positive interim data from the Phase 2 CALLIPER trial showing a 6.7% reduction in serum NfL at 24 weeks compared to a 15.8% increase in placebo[136][137]. - The Phase 2 CALLIPER trial has completed enrollment with 467 patients, and top-line data is expected in April 2025[139]. - IMU-856 has shown positive effects in a Phase 1 clinical trial for celiac disease, demonstrating improvements in gut architecture and patient symptoms[126]. - Positive results from the Phase 1b clinical trial of IMU-856 showed improvements in gut architecture protection, symptom relief, biomarker response, and nutrient absorption in celiac disease patients[143]. - The Phase 3 ENSURE and Phase 2 CALLIPER clinical trial programs for vidofludimus calcium in multiple sclerosis (MS) are ongoing[140]. - Vidofludimus calcium demonstrated a 33.7% absolute improvement over placebo in achieving clinical remission at week 50 in the Phase 2b CALDOSE-1 trial for moderate-to-severe ulcerative colitis (UC)[148]. - The maintenance phase data of CALDOSE-1 confirms vidofludimus calcium's activity without chronic corticosteroid co-administration, indicating safety and tolerability[150]. Financial Performance - The company reported a net loss of $22.8 million for the three months ended September 30, 2023, compared to a net loss of $21.2 million for the same period in 2022, reflecting a 7% increase in losses[162]. - Total operating expenses increased by 17% to $23.6 million for the three months ended September 30, 2023, compared to $20.1 million for the same period in 2022[162]. - Research and development expenses increased by 20% to $19.8 million for the three months ended September 30, 2023, compared to $16.5 million for the same period in 2022[162]. - Total operating expenses for the nine months ended September 30, 2023, increased by 22% to $75.8 million compared to $62.2 million in 2022[165]. - Research and development expenses rose by 27% to $63.9 million, driven by a $10.1 million increase in external development costs for the Phase 3 clinical program of vidofludimus calcium[165]. - The net loss for the nine months ended September 30, 2023, was $72.0 million, a 13% increase from the $63.9 million loss in 2022[165]. Strategic Focus - Immunic has no products approved for commercial sale and has incurred operating losses since its inception in 2016, with significant expenses expected to continue[131][132]. - The company is exploring options to support further development of its antiviral portfolio, including potential spin-offs and licensing transactions[128]. - Immunic's strategy focuses on developing new molecules targeting immunological conditions with high unmet needs, leveraging its research infrastructure in Germany and Australia[134]. - The company is deprioritizing the izumerogant development program to focus resources on the advancing vidofludimus calcium and IMU-856 programs[151]. Other Financial Information - Other income increased by $1.9 million during the three months ended September 30, 2023, primarily due to a decrease in foreign exchange losses and an increase in interest income[164]. - Other income increased by $5.6 million, mainly from a $2.2 million rise in interest income and a $3.2 million decrease in foreign exchange losses[167]. - There were no significant changes in critical accounting policies or estimates during the first nine months of 2023[188]. - The company has not entered into any off-balance sheet arrangements as of September 30, 2023[185]. - Inflation has led to a general increase in costs, but it has not materially impacted the company's results of operations[194].