18 unchanged sentences
Other Information.
+Added: During the three months ended December 31, 2024, none of our directors or officers adopted, made certain modifications or terminated a “Rule 10b5-1 trading arrangement” or “non-Rule 10b5-1 trading arrangement,” as each term is defined in Item 408(a) of Regulation S-K.
Disclosure Regarding Foreign Jurisdictions that Prevent Inspections
34 unchanged sentences
8-K 3.1 July 17, 2019
+Added: 3.3 Certificate of Amendment to the Amended and Restated Certificate of Incorporation of Immunic, Inc.
+Added: 8-K 3.1 March 8, 2024
4.1 2019 Omnibus Equity Incentive Plan, as amended ,
6 unchanged sentences
10.1+ Addendum No.
−Removed: 5, dated October 17, 2023, to Employment Agreement, dated April 17, 2020, between Immunic, Inc.
+Added: 6, dated August 29, 2024, to Employment Agreement, dated April 17, 2020, between Immunic, Inc.
and Duane Nash.
−Removed: 8-K 10.1 October 17, 2023
+Added: 8-K 10.1 September 3, 2024
10.2+ Employment Agreement, dated December 18, 2023, between Immunic, Inc.
36 unchanged sentences
8-K 10.1 October 14, 2021
+Added: 10.16+ Employee Agreement, dated July 9, 2024, between Immunic, Inc.
+Added: and Jason Tardio
+Added: 10.17 Employment agreement dated December 13, 2024, between Immunic, Inc.
+Added: 8-K 10.1 December 18, 2024
19.1* Immunic, Inc.
25 unchanged sentences
Such certifications will not be deemed to be incorporated by reference into any filings under the Securities Act or the Exchange Act, except to the extent that the registrant specifically incorporates it by reference.
+Added: Form 10-K Summary
IMMUNIC, INC.
13 unchanged sentences
In our opinion, the consolidated financial statements present fairly, in all material respects, the financial position of the Company as of December 31, 2024 and 2023, and the results of its operations and its cash flows for each of the two years in the period ended December 31, 2024, in conformity with accounting principles generally accepted in the United States of America.
+Added: Going Concern
+Added: The accompanying consolidated financial statements have been prepared assuming the Company will continue as a going concern.
+Added: As discussed in Note 1 of the consolidated financial statements, the Company has recurring losses from operations, expects to incur losses for the foreseeable future and needs additional working capital.
+Added: These factors raise substantial doubt about the Company’s ability to continue as a going concern.
+Added: Management’s plans in regard to these matters are also described in Note 1.
+Added: The consolidated financial statements do not contain any adjustments that might result from the outcome of this uncertainty.
Basis for Opinion
13 unchanged sentences
Critical Audit Matter
−Removed: The critical audit matter communicated below is a matter arising from the current period audit of the financial statements that was communicated or required to be communicated to the audit committee and that:
−Removed: (1) relates to accounts or disclosures that are material to the financial statements and (2) involved our especially challenging, subjective, or complex judgments.
−Removed: The communication of critical audit matters does not alter in any way our opinion on the financial statements, taken as a whole, and we are not, by communicating the critical audit matter below, providing separate opinions on the critical audit matters or on the accounts or disclosures to which it relates.
−Removed: Assessment of accrual for research and development costs related to clinical trial activities
−Removed: Critical Audit Matter Description
−Removed: As described in Note 2 and 3 to the consolidated financial statements, the Company records expenses and accruals for estimated costs of research and development activities, including third party contract services costs for clinical research.
−Removed: Clinical trial activities performed by third parties are expensed based upon estimates of work completed in accordance with agreements with the respective Clinical Research Organization.
−Removed: Billing terms and payments are reviewed by management to ensure estimates of outstanding obligations are appropriate as of period end.
−Removed: Tracking the progress of completion for clinical trial activities performed by third parties allows the Company to record the appropriate expense and accruals under the terms of the agreements.
−Removed: Auditing the accounting for accrued clinical trial expenses is complex because of the high volume of data used in management’s estimates, the assumptions used by management to develop their estimates and the procedures necessary to verify the cost and extent of unbilled work performed during the reporting period.
−Removed: How We Addressed the Matter in Our Audit
−Removed: We obtained an understanding of the Company’s process and evaluated the design and implementation of internal controls related to the completeness and valuation of accrued clinical trial expenses.
−Removed: To test the clinical trial accrual, our audit procedures included, among others, testing the accuracy and completeness of the underlying data used in the estimates and evaluating and testing the significant assumptions used by management to estimate the accruals.
−Removed: To test the significant assumptions, we corroborated the progress of clinical trials and other research and development projects with the Company’s research and development personnel that oversee the clinical trials, and obtained information received directly from third parties, which included the third parties’ estimate of costs incurred to date.
−Removed: We also tested subsequent invoicing received from third parties.
+Added: Critical audit matters are matters arising from the current period audit of the financial statements that were communicated or required to be communicated to the audit committee and that:
+Added: (1) relate to accounts or disclosures that are material to the financial statements and (2) involved our especially challenging, subjective, or complex judgments.
+Added: We determined that there are no critical audit matters.
Baker Tilly US, LLP
1 unchanged sentence
Minneapolis, MN
−Removed: February 22, 2024
+Added: March 31, 2025
IMMUNIC, INC.
3 unchanged sentences
Cash and cash equivalents $ 35,668 $ 46,674
−Removed: Investments - other — 9,629
Prepaid expenses and other current assets 3,664 5,860
2 unchanged sentences
Right of use asset, net 991 1,299
−Removed: Other long-term assets — 43
Total assets $ 40,868 $ 54,299
14 unchanged sentences
Common stock, $ 0.0001 par value;
−Removed: 130,000,000 shares authorized and 45,177,730 and 39,307,286 shares issued and outstanding at December 31, 2023 and 2022, respectively
+Added: 500,000,000 and 130,000,000 shares authorized as of December 31, 2024 and December 31, 2023, respectively, and 90,150,869 and 45,177,730 shares issued and outstanding as of December 31, 2024 and December 31, 2023, respectively.
Additional paid-in capital 525,611 436,060
11 unchanged sentences
General and administrative 18,006 16,008
−Removed: Goodwill impairment (see Note 2) — 32,970
Total operating expenses 98,052 99,223
2 unchanged sentences
Interest income 3,390 3,075
+Added: Change in fair value of the tranche rights ( 4,796 ) —
Other income (expense), net ( 1,049 ) 2,536
10 unchanged sentences
Other comprehensive income:
−Removed: Foreign currency translation income, net of tax 724 3,287
+Added: Foreign currency translation 450 724
Total comprehensive loss $ ( 100,057 ) $ ( 92,888 )
5 unchanged sentences
Comprehensive
−Removed: Income (Loss) Accumulated
+Added: Income Accumulated
Deficit Total
5 unchanged sentences
Stock-based compensation — — 7,102 — — 7,102
−Removed: Issuance of common stock and Pre-funded Warrants - October 2022 PIPE transaction, net of issuance costs of $ 4,012
−Removed: 8,696,552 1 55,988 — — 55,989
+Added: Shares issued from the exercise of pre-funded warrants 5,096,552 — 51 — — 51
Issuance of common stock - At The Market Sales Agreement net of issuance costs of $ 26
1 unchanged sentence
Shares issued in connection with the Company's employee stock purchase plan 116,880 — 129 — — 129
−Removed: Shares issued in connection with the Company's stock option plan 852 — 5 — — 5
Balance at December 31, 2023 45,177,730 4 $ 436,060 $ 3,759 $ ( 410,892 ) $ 28,931
2 unchanged sentences
Stock-based compensation — — 8,527 — — 8,527
−Removed: Shares issued from exercise of pre-funded warrants 5,096,552 — 51 — — 51
+Added: Issuance of common stock and pre-funded warrants - January 2024 Financing, net of issuance costs of $ 4,037
+Added: 44,751,286 4 52,360 — — 52,364
Issuance of common stock - At The Market Sales Agreement net of issuance costs of $ 6
150,000 — 191 — — 191
+Added: Conversion of tranche rights liability to equity — — 28,396 — — 28,396
Shares issued in connection with the Company's employee stock purchase plan 71,853 — 77 — — 77
9 unchanged sentences
Depreciation and amortization 134 111
−Removed: Goodwill impairment (see Note 2) — 32,970
Stock-based compensation 8,527 7,102
+Added: Change in fair value of tranche rights 4,796 —
+Added: Fees expensed as part of January 2024 Financing 1,690 —
Foreign currency loss 30 523
Changes in operating assets and liabilities:
−Removed: Prepaid expenses and other current assets 3,858 7,493
+Added: Other current assets and prepaid expenses 1,863 3,858
Accounts payable 3,145 817
Other liabilities 416 96
−Removed: Accrued expenses and other current liabilities 10,277 1,362
+Added: Accrued expenses ( 4,860 ) 10,277
Net cash used in operating activities ( 84,766 ) ( 70,828 )
Cash flows from investing activities:
−Removed: (Purchases) sales of Investments-other 9,796 ( 9,629 )
+Added: Sales of Investments-other — 9,796
Purchases of property and equipment ( 264 ) ( 334 )
1 unchanged sentence
Cash flows from financing activities:
−Removed: Proceeds from public offering of common stock through At The Market offering, net of issuance costs of $ 26 and $ 1,226 , respectively
+Added: Proceeds from January 2024 Financing, net of issuance costs 74,273 —
+Added: Proceeds from public offering of common stock through At The Market offering, net of issuance costs 191 853
Proceeds from shares issued in connection with the Company's employee stock purchase plan 77 129
−Removed: Issuance of common stock and Pre-funded Warrants - October 2022 PIPE transaction, net of issuance costs of $ 0 and $ 4,012 , respectively
−Removed: Proceeds from the exercise of stock options — 5
Proceeds from the exercise of pre-funded warrants — 51
5 unchanged sentences
Supplemental disclosure of noncash investing and financing activities:
+Added: Conversion of tranche rights liability to equity upon increase in authorized shares $ 28,396 $ —
Operating lease right-of use asset obtained in exchange for lease obligation $ 448 $ 544
6 unchanged sentences
The Company is headquartered in New York City with its main operations in Gräfelfing near Munich, Germany.
−Removed: The Company had 77 employees as of February 1, 2024.
−Removed: Immunic is pursuing clinical development of orally administered, small molecule programs, each of which has unique features intended to directly address the unmet needs of patients with serious chronic inflammatory and autoimmune diseases.
−Removed: These include the vidofludimus calcium (IMU-838) program, which is in Phase 3 clinical development for patients with multiple sclerosis (“MS”) and which has shown therapeutic activity in Phase 2 clinical trials in patients suffering from relapsing-remitting MS, progressive MS and moderate-to-severe ulcerative colitis;
−Removed: the IMU-856 program, which is targeted to regenerate bowel epithelium and restore intestinal barrier function, which could potentially be applicable in numerous gastrointestinal diseases, such as celiac disease, inflammatory bowel disease, short bowel syndrome and irritable bowel syndrome with diarrhea;
+Added: The Company had 91 employees as of March 1, 2025.
+Added: The Company is pursuing clinical development of orally administered, small molecule programs, each of which has unique features intended to directly address the unmet needs of patients with serious chronic inflammatory and autoimmune diseases.
+Added: These include the vidofludimus calcium (IMU-838) program, which is in Phase 3 and Phase 2 clinical development for patients with relapsing and progressive multiple sclerosis (“MS”), respectively, and which has shown therapeutic activity in Phase 2 clinical trials in patients suffering from relapsing-remitting MS ("RRMS"), progressive MS and moderate-to-severe ulcerative colitis (“UC”);
+Added: the IMU-856 program, which is targeted to regenerate bowel epithelium and restore intestinal barrier function, which could potentially be applicable in numerous gastrointestinal diseases, such as celiac disease, inflammatory bowel disease ("IBD"), Graft-versus-Host-Disease ("GvHD") and weight management;
and the IMU-381 program, which is a next generation molecule being developed to specifically address the needs of gastrointestinal diseases.
The Company’s business, operating results, financial condition and growth prospects are subject to significant risks and uncertainties, including the failure of its clinical trials to meet their endpoints, failure to obtain regulatory approval and needing additional funding to complete the development and commercialization of the Company's three development programs.
−Removed: Liquidity and Financial Condition
+Added: Going Concern and Liquidity and Financial Condition
Immunic has no products approved for commercial sale and has not generated any revenue from product sales.
−Removed: Immunic has never been profitable and has incurred operating losses in each year since inception (2016).
−Removed: Immunic has an accumulated deficit of approximately $ 410.9 million as of December 31, 2023 and approximately $ 317.3 million as of December 31, 2022.
+Added: It has never been profitable and has incurred operating losses in each year since inception in 2016.
+Added: The Company has an accumulated deficit of approximately $ 511.4 million as of December 31, 2024 and $ 410.9 million as of December 31, 2023.
+Added: Substantially all of Immunic's operating losses resulted from expenses incurred in connection with its research and development programs and from general and administrative costs associated with its operations.
Immunic expects to incur significant expenses and increasing operating losses for the foreseeable future as it initiates and continues the development of its product candidates and adds personnel necessary to advance its pipeline of product candidates.
Immunic expects that its operating losses will fluctuate significantly from quarter-to-quarter and year-to-year due to timing of development programs.
−Removed: From inception through January 31, 2024, Immunic has raised net cash of approximately $ 431.4 million from private and public offerings of preferred and common stock.
−Removed: As of December 31, 2023, the Company had cash and cash equivalents of approximately $ 46.7 million.
−Removed: On January 4, 2024, we raised net cash proceeds in a private placement of approximately $ 75.0 million.
−Removed: With these funds we expect to be able to fund our operations beyond twelve months from the date of the issuance of the accompanying consolidated financial statements.
+Added: From inception through December 31, 2024, Immunic has raised net cash of approximately $ 430.9 million from private and public offerings of preferred stock, common stock, pre-funded warrants and tranche rights.
+Added: As of December 31, 2024, the Company had cash and cash equivalents of approximately $ 35.7 million.With these funds, the Company does not have adequate liquidity to fund its operations for at least twelve months from the issuance of these consolidated financial statements without raising additional capital, but such actions are not solely within the control of the Company.
+Added: If the Company is unable to obtain additional capital, it would have a material adverse effect on the operations of the Company, its clinical development program, and the Company may have to cease operations altogether.
+Added: These factors raise substantial doubt about the Company’s ability to continue as a going concern.
Basis of Presentation and Consolidation
7 unchanged sentences
GAAP requires the Company to make certain estimates and assumptions that affect the reported amounts of assets, liabilities, expenses and the disclosure of contingent assets and liabilities in the Company’s consolidated financial statements.
−Removed: The most significant estimates in the Company’s financial statements and accompanying notes relate to clinical trial expenses and share-based compensation.
+Added: The most significant estimates in the Company’s financial statements and accompanying notes relate to stock-based compensation and the valuation of the tranche rights.
Management believes its estimates to be reasonable under the circumstances.
17 unchanged sentences
The Company considers all highly liquid investments with an original maturity of three months or less to be cash equivalents.
−Removed: Time Deposits with an original maturity greater than three months are classified as Investments - other.
−Removed: Cash and cash equivalents and investments - other consist of cash on hand and deposits in banks located in the U.S.
+Added: Cash and cash equivalents consist of cash on hand and deposits in banks located in the U.S.
of approximately $ 15.1 million, Germany of approximately $ 20.5 million and Australia of approximately $ 0.1 million as of December 31, 2024.
5 unchanged sentences
Cash and cash equivalents in the U.S.
−Removed: are held at J.P.
−Removed: Morgan and as of December 31, 2023 are primarily held in a U.S.
−Removed: Government money market fund account earning interest at a rate of 5.2 %.
−Removed: Cash and cash equivalents in Germany were earning interest at a rate of 2.00 % to 3.25 % during the period ended December 31, 2023.
−Removed: Investments - other consists of the following as of (in thousands):
−Removed: December 31, 2023 December 31, 2022
−Removed: Time Deposits $ 0 $ 9,629
+Added: are held at JP Morgan and are primarily held in a U.S.
+Added: Government money market fund account earning interest at a rate of 4.3 % as of December 31, 2024.
+Added: Cash and cash equivalents in Germany are earning interest at a rate of 2.75 % to 3.25 % as of December 31, 2024.
Fair Value Measurement
10 unchanged sentences
The Company had no Level 3 assets or liabilities for the periods presented.
+Added: The Company did have tranche rights that were at level 3 during the first quarter of 2024.
The carrying value of cash and cash equivalents, other current assets and prepaid expenses, accounts payable, accrued expenses, and other current liabilities approximates fair value due to the short period of time to maturity.
6 unchanged sentences
Impaired assets are then recorded at their estimated fair value.
−Removed: There were no impairment losses during the years ended December 31, 2023 and 2022 other than goodwill which is described below.
−Removed: Business combinations are accounted for under the acquisition method.
−Removed: The total purchase price of an acquisition is allocated to the underlying identifiable net assets, based on their respective estimated fair values as of the acquisition date.
−Removed: Determining the fair value of assets acquired and liabilities assumed requires management’s judgment and often involves the use of significant estimates and assumptions, including assumptions with respect to future cash inflows and outflows, probabilities of success, discount rates, and asset lives, among other items.
−Removed: Assets acquired and liabilities assumed are recorded at their estimated fair values.
−Removed: The excess of the purchase price over the estimated fair values of the net assets acquired is recorded as goodwill.
−Removed: Goodwill is tested for impairment at the reporting unit level annually in the fourth quarter, or more frequently when events or changes in circumstances indicate that the asset might be impaired.
−Removed: Examples of such events or circumstances include, but are not limited to, an unfavorable clinical trial result, a significant adverse change in legal or business climate, industry market conditions, an adverse regulatory action, sustained decrease in stock price or unanticipated competition.
−Removed: On October 20, 2022, the Company announced the outcome of a significant interim analysis of its Phase 1b clinical trial of izumerogant (IMU-935) in patients with moderate-to-severe psoriasis, which was not deemed positive progress.
−Removed: On October 21, 2022, the Company experienced a significant decrease in the Company's market capitalization.
−Removed: The Company considered this to be a triggering event, indicating that it is more likely than not that goodwill was impaired.
−Removed: The Company performed an analysis of the fair value compared to the Company's book value, utilizing the Company's traded stock price (a level 1 fair value input).
−Removed: As a result of that analysis, the Company recorded an approximately $ 33.0 million non-cash goodwill impairment charge in the fourth quarter of 2022, which represents a full write down of its previous goodwill balance.
+Added: There were no impairment losses during the years ended December 31, 2024 and 2023.
Research and Development Expenses
−Removed: These costs primarily include external development expenses and internal personnel expenses for its development programs, vidofludimus calcium, izumerogant and IMU-856.
+Added: These costs primarily include external development expenses and internal personnel expenses for its development programs, vidofludimus calcium and IMU-856.
Immunic has spent the majority of its research and development resources on vidofludimus calcium, the Company's lead development program, for clinical trials in MS and UC.
7 unchanged sentences
non-refundable or partially refundable upfront or license fees;
−Removed: development, regulatory and commercial milestone
+Added: development, regulatory and commercial milestone payments;
payment for manufacturing supply services;
13 unchanged sentences
In connection with the option exercise, the Company paid a one-time upfront licensing fee to Daiichi Sankyo.
−Removed: Under the Daiichi Sankyo Agreement, Daiichi Sankyo is also eligible to receive future development, regulatory and sales milestone payments, as well as royalties related to IMU-856.
+Added: Under the Daiichi
+Added: Sankyo Agreement, Daiichi Sankyo is also eligible to receive future development, regulatory and sales milestone payments, as well as royalties related to IMU-856.
Government assistance
1 unchanged sentence
This government assistance is recognized at a rate of 43.5 % of the qualified research and development expenditures which are incurred.
−Removed: We also receive government assistance from the German Government for reimbursement of research and development expenses up to one million Euros per year.
−Removed: We recognized $ 3.3 million and $ 2.6 million of other income related to research activities performed during the twelve months ended December 31, 2023 and 2022, respectively.
+Added: We also receive government assistance from the German Government for reimbursement of research and development expenses up to 3.5 million Euros per year.
+Added: We recognized $ 0.7 million and $ 3.3 million of other income related to research activities performed during the years ended December 31, 2024 and 2023, respectively.
General and Administrative Expenses
3 unchanged sentences
The Company measures the cost of employee and non-employee services received in exchange for equity awards based on the grant-date fair value of the award recognized generally as an expense (i) on a straight-line basis over the requisite service period for those awards whose vesting is based upon a service condition, and (ii) on an accelerated method for awards whose vesting is based upon a performance condition, but only to the extent it is probable that the performance condition will be met.
−Removed: Stock-based compensation is (i) estimated at the date of grant based on the award’s fair value for equity classified awards and (ii) final measurement date for liability classified awards.
+Added: Stock-based compensation is (i) estimated at the date of grant based on the award’s fair value for equity classified awards and (ii) based on the final measurement date for liability classified awards.
Forfeitures are recorded in the period in which they occur.
15 unchanged sentences
Variable lease costs such as common area costs and property taxes are expensed as incurred.
−Removed: Leases with an initial term of twelve months or less are not recorded on the balance sheet.
Comprehensive Income (Loss)
Comprehensive income (loss) is defined as the change in equity during a period from transactions and other events and circumstances from non-owner sources.
−Removed: Accumulated other comprehensive income (loss) has been reflected as a separate component of stockholders’ equity in the accompanying Consolidated Balance Sheets and consists of foreign currency translation adjustments (net of tax).
+Added: Accumulated other comprehensive income (loss) has been reflected as a separate component of stockholders’ equity in the accompanying Consolidated Balance Sheets and consists of foreign currency translation adjustments.
The Company is subject to corporate income tax laws and regulations in the U.S., Germany and Australia.
13 unchanged sentences
The Company is not currently under examination by any tax jurisdictions.
−Removed: The Company accounts for issued warrants either as a liability or equity in accordance with ASC 480-10, Accounting for Certain Financial Instruments with Characteristics of both Liabilities and Equity (“ASC 480-10”) or ASC 815-40, Accounting for Derivative Financial Instruments Indexed to, and Potentially Settled in, a Company’s Own Stock (“ASC 815-40”).
−Removed: Under ASC 480-10, warrants are considered a liability if they are mandatorily redeemable and they require settlement in cash, other assets, or a variable number of shares.
−Removed: If warrants do not meet liability classification under ASC 480-10, the Company considers the requirements of ASC 815-40 to determine whether the warrants should be classified as a liability or as equity.
−Removed: Under ASC 815-40, contracts that may require settlement for cash are liabilities, regardless of the probability of the occurrence of the triggering event.
−Removed: Liability-classified warrants are measured at fair value on the issuance date and at the end of each reporting period.
−Removed: Any change in the fair value of the warrants after the issuance date is recorded in the consolidated statements of operations as a gain or loss.
−Removed: If warrants do not require liability classification under ASC 815-40, in order to conclude warrants should be classified as equity, the Company assesses whether the warrants are indexed to its common stock and
−Removed: whether the warrants are classified as equity under ASC 815-40 or other applicable GAAP standard.
−Removed: Equity-classified warrants are accounted for at fair value on the issuance date with no changes in fair value recognized after the issuance date.
+Added: Warrants and Tranche Rights
+Added: The Company accounts for issued financial instruments either as a liability or equity in accordance with ASC 480-10, Accounting for Certain Financial Instruments with Characteristics of both Liabilities and Equity (“ASC 480-10”) or ASC 815-40, Accounting for Derivative Financial Instruments Indexed to, and Potentially Settled in, a Company’s Own Stock (“ASC 815-40”).
+Added: If financial instruments do not meet liability classification under ASC 480-10, the Company considers the requirements of ASC 815-40 to determine whether the financial instruments should be classified as a liability or as equity.
+Added: Liability-classified financial instruments are measured at fair value on the issuance date and at the end of each reporting period.
+Added: Any change in the fair value of the financial instruments after the issuance date is recorded in the consolidated statements of operations as a gain or loss.
+Added: If financial instruments do not require liability classification under ASC 815-40, the instrument is classified in permanent equity.
+Added: Equity-classified financial instruments are accounted for at fair value on the issuance date with no changes in fair value recognized after the issuance date.
Net Loss Per Share
2 unchanged sentences
For all periods presented, there is no difference in the number of shares used to calculate basic and diluted shares outstanding due to the Company’s net loss position.
+Added: The weighted average shares outstanding calculation for basic and diluted earnings per share for the year ended December 31, 2024 includes 11,193,564 pre-funded warrants that remain unexercised as of December 31, 2024.
Potentially dilutive securities, not included in the calculation of diluted net loss per share attributable to common stockholders because to do so would be anti-dilutive, are as follows:
1 unchanged sentence
Options to purchase common stock 16,136,045 6,196,140
−Removed: Prefunded stock warrants — 5,096,552
−Removed: 6,196,140 8,888,240
Recently Adopted Accounting Standards
−Removed: There are no recently issued accounting standards that would have a significant impact on the Company's consolidated financial statements.
+Added: During the year ended December 31, 2024, the Company adopted ASU 2023-07 which requires public companies with a single reportable segment to meet all existing disclosure requirements of Topic 280 and additional disclosures.
+Added: Single reportable segment entities must now provide qualitative disclosures about factors used to identify reportable segments and types of products and services, as well as quantitative disclosures of profit or loss measures and significant expense categories.
+Added: Retrospective application is required to all periods in financial statements unless impracticable, in which case companies must disclose this fact and the reasons why.
+Added: Future Accounting Standards
+Added: In December 2023, the FASB issued ASU No.
+Added: 2023-09, Income Taxes (Topic 740):
+Added: Improvements to Income Tax Disclosures.
+Added: The new guidance is expected to improve income tax disclosures primarily related to the rate reconciliation and income taxes paid information by requiring 1) consistent categories and greater disaggregation of information in the rate reconciliation and 2) income taxes paid disaggregated by jurisdiction.
+Added: The guidance is effective on a prospective basis, although retrospective application and early adoption is permitted.
+Added: The standard will be adopted for the annual period starting January 1, 2025.
Balance Sheet Details
25 unchanged sentences
Total $ 1,416 $ 966
−Removed: Commitments and Contingencies
−Removed: Operating Lease
+Added: Operating Leases
The Company leases certain office space under non-cancelable operating leases.
−Removed: The leases terminate on July 31, 2025 for the New York City office, June 30, 2025 for the Gräfelfing, Germany office and November 30, 2028 related to the new lease of a research laboratory in Planegg, Germany.
+Added: The leases terminate on July 31, 2026 for the New York City office, December 31, 2025 for the Gräfelfing, Germany office and November 30, 2028 for the research laboratory in Planegg, Germany.
These agreements include both lease (e.g., fixed rent) and non-lease components (e.g., common-area and other maintenance costs).
The non-lease components are deemed to be executory costs and are therefore excluded from the minimum lease payments used to determine the present value of the operating lease obligation and related right-of-use asset.
−Removed: The New York City lease was extended on December 22, 2022 for an additional 27 months resulting in the new lease termination date of July 31, 2025.
+Added: The New York City lease was extended on November 8, 2024 for an additional 12 months resulting in the new lease termination date of July 31, 2026.
The New York City lease has a renewal option, but this was not included in calculating the right of use asset and liabilities.
1 unchanged sentence
On March 1, 2021 and August 1, 2022 the Company added additional lease space at the Gräfelfing, Germany office.
+Added: The lease term has expired, however, the Company is currently operating on a one-year monthly rolling lease and the Company needs to provide one-years notice to terminate the lease.
Renewal options were not included in calculating the right of use asset and liabilities for this facility.
2 unchanged sentences
Further, the leases do not contain contingent rent provisions.
−Removed: The New York City lease had a six month rent holiday at the beginning of the lease as well as a three month rent holiday upon the 27 month extension starting May 2023.
−Removed: There were net additions of $ 544,000 related to the addition of new laboratory space in Planegg, Germany in February 2023.
+Added: There were net additions of $ 448,000 related to the extension of the New York City lease and Gräfelfing offices during the year ended December 31, 2024.
+Added: There were net additions of $ 544,000 related to the addition of new laboratory space in Planegg, Germany during the year ended December, 31 2023.
The leases do not provide an implicit rate and, due to the lack of a commercially salable product, the Company is generally considered unable to obtain commercial credit.
1 unchanged sentence
Immunic used its estimated incremental borrowing rate and other information available at the lease commencement date in determining the present value of the lease payments.
−Removed: Immunic’s operating lease costs and variable lease costs were $ 901,000 and $ 727,000 for the years ended December 31, 2023 and 2022, respectively.
+Added: Immunic’s operating lease costs and variable lease costs were $ 1.1 million and $ 0.9 million for the years ended December 31, 2024 and 2023, respectively.
Variable lease costs consist primarily of common area maintenance costs, insurance and taxes which are paid based upon actual costs incurred by the lessor.
+Added: The non-cash lease expense for the years ended December 31, 2024 and 2023 was approximately $0.4 million and $0.7 million respectively.
Maturities of the operating lease obligation are as follows as of December 31, 2024 (in thousands):
3 unchanged sentences
Present value of lease obligation $ 1,004
−Removed: Contractual Obligations
−Removed: As of December 31, 2023, the Company has non-cancelable contractual obligations under certain agreements related to its development programs in vidofludimus calcium, izumerogant and IMU-856 totaling approximately $ 4.2 million, all of which is expected to be paid in 2024.
−Removed: Other Commitments and Obligations
−Removed: Daiichi Sankyo Agreement
−Removed: On January 5, 2020, the Company exercised its option to obtain the exclusive worldwide right to commercialization of IMU-856.
−Removed: Among other things, the option exercise grants Immunic AG the rights to Daiichi Sankyo’s patent application related to IMU-856, for which the Company received a notice of allowance from the U.S.
−Removed: Patent & Trademark Office in August 2022.
−Removed: In connection with the option exercise, the Company paid a one-time upfront licensing fee to Daiichi Sankyo.
−Removed: Under the Daiichi
−Removed: Sankyo Agreement, Daiichi Sankyo is also eligible to receive future development, regulatory and sales milestone payments, as well as royalties related to IMU-856.
−Removed: Legal Proceedings
−Removed: The Company is not currently a party to any litigation, nor is it aware of any pending or threatened litigation, that it believes would materially affect its business, operating results, financial condition or cash flows.
−Removed: However, its industry is characterized by frequent claims and litigation including securities litigation, claims regarding patent and other intellectual property rights and claims for product liability.
−Removed: As a result, in the future, the Company may be involved in various legal proceedings from time to time.
The following fair value hierarchy table present information about each major category of the Company’s financial assets and liabilities measured at fair value on a recurring basis (in thousands):
8 unchanged sentences
There were no transfers between Level 1, Level 2 or Level 3 assets during the periods presented.
−Removed: For the Company’s money market funds which are included as a component of cash and cash equivalents on the consolidated balance sheet, realized gains and losses are included in interest income (expense) on the consolidated statements of operations.
+Added: For the Company’s money market funds which are included as a component of cash and cash equivalents on the consolidated balance sheet, realized gains and losses are included in interest income on the consolidated statements of operations.
Our money market fund account is held in our bank in the U.S.
3 unchanged sentences
The Company has not historically experienced any credit losses with balances in excess of FDIC limits.
+Added: The Company recorded tranche rights of $ 23.6 million at January 8, 2024 as a result of the January 2024 Financing (see note 6).
+Added: The fair value measurement of the tranche rights associated with the January 2024 Financing was classified as Level 3 under the fair value hierarchy.
+Added: The fair value of the tranche rights was determined using a Black Scholes Option Pricing Model.
+Added: The inputs to this model included a risk-free rate range of 3.93 %- 4.36 %, a stock price volatility range of 105 - 115 %, an expected dividend rate of — % and remaining term of 1.81 - 4.81 years.
+Added: This liability was revalued on March 4, 2024, upon stockholder approval to increase its authorized shares of common stock from 130 million to 500 million, which resulted in the reclassification of the tranche rights from a liability to equity.
+Added: This revaluation resulted in an increase in the tranche rights liability of $ 4.8 million using a Black Scholes Option Pricing Model.
+Added: The inputs to this model as of the date of the reclassification included a risk-free rate range of 4.16 %- 4.63 %, a stock price volatility range of 90 - 105 %, an expected dividend rate of — % and remaining term of 1.66 - 4.66 years.
+Added: The inputs used in the determination of fair value of the liability are level 3 inputs.
+Added: A rollforward of the fair value of the tranche rights is as follows (in thousands):
+Added: December 31, 2023 $ —
+Added: Fair value as of January 8, 2024 $ 23,600
+Added: Change in fair value through March 4, 2024 $ 4,796
+Added: Reclassification to equity in March 2024 $ ( 28,396 )
+Added: December 31, 2024 $ —
The carrying amounts of other current assets and prepaid expenses, accounts payable, accrued expenses, and other current liabilities approximate their fair values due to their short-term nature.
1 unchanged sentence
Shelf Registration Statements
−Removed: In November 2023, we filed a shelf registration statement on Form S-3 (the "2023 Shelf Registration Statement").
−Removed: The 2023 Shelf Registration Statement permits the offering, issuance and sale of up to $ 250.0 million of common stock, preferred stock, warrants, debt securities, and/or units in one or more offerings and in any combination of the foregoing.
−Removed: As of January 31, 2024, the 2023 Shelf Registration statement has not been made effective, however, the Company can (i) continue to sell, subject to applicable SEC requirements, unsold securities remaining on the expiring 2020 Shelf Registration Statement;
−Removed: and (ii) offer and sell additional securities to be registered on the new Form S-3.
+Added: In December 2020, the Company filed a Prospectus Supplement to the shelf registration statement on Form S-3 filed on November 13, 2020 and declared effective on November 24, 2020 (the "2020 Shelf Registration Statement") for the offering, issuance and sale of up to a maximum aggregate offering price of $ 50.0 million of common stock that may be issued and sold under an at-the-market sales agreement with SVB Leerink LLC (now Leerink Partners LLC) as agent ("December 2020 ATM").
+Added: The Company used the net proceeds from the December 2020 ATM to fund the ongoing clinical development of our product candidates and for other general corporate purposes, including funding existing and potential new clinical programs and product candidates.
+Added: The December 2020 ATM terminated in May 2024.
+Added: In May 2022, the Company filed a Prospectus Supplement to the 2020 Shelf Registration Statement for the offering, issuance and sale of up to a maximum aggregate offering price of $ 80.0 million of common stock to be issued and sold under another at-the-market sales agreement ("May 2022 ATM") with Leerink Partners LLC (formerly SVB Leerink LLC) as agent.
+Added: The 2020 Shelf Registration Statement expired in November 2023.
In November 2023, we filed a shelf registration statement on Form S-3 (the "2023 Shelf Registration Statement").
The 2023 Shelf Registration Statement permits the offering, issuance and sale of up to $ 250.0 million of common stock, preferred stock, warrants, debt securities, and/or units in one or more offerings and in any combination of the foregoing.
−Removed: As of December 31, 2024, there is $ 75.0 million remaining on this shelf registration statement.
−Removed: In December 2020, we filed a Prospectus Supplement for the offering, issuance and sale of up to a maximum aggregate offering price of $ 50.0 million of common stock that may be issued and sold under an at-the-market sales agreement with SVB Leerink LLC (now Leerink Partners LLC) as agent ("December 2020 ATM").
−Removed: We have used and intend to continue to use the net proceeds from the December 2020 ATM to continue to fund the ongoing clinical development of our product candidates and for other general corporate purposes, including funding existing and potential new clinical programs and product candidates.
−Removed: The December 2020 ATM will terminate upon the earlier of (i) the issuance and sale of all of the shares through Leerink Partners LLC on the terms and subject to the conditions set forth in the December 2020 ATM or (ii) termination of the December 2020 ATM as otherwise permitted thereby.
−Removed: The December 2020 ATM may be terminated at any time by either party upon ten days’ prior notice, or by Leerink Partners LLC at any time in certain circumstances, including the occurrence of a material adverse effect on us.
−Removed: As of December 31, 2024, $ 7.5 million in capacity remains under the December 2020 ATM.
−Removed: In May 2022, the Company filed a Prospectus Supplement for the offering, issuance and sale of up to a maximum aggregate offering price of $ 80.0 million of common stock that may be issued and sold under another at-the-market sales agreement ("May 2022 ATM") with Leerink Partners LLC (formerly SVB Leerink LLC) as agent.
−Removed: The Company intends to use the net proceeds from the offering to continue to fund the ongoing clinical development of its product candidates and for other general corporate purposes, including funding existing and potential new clinical programs and product candidates.
+Added: This registration statement was declared effective on May 31, 2024.
+Added: Unsold securities from the expired 2020 shelf registration statement can continue to be sold under the 2023 Shelf Registration Statement resulting in a total S-3 shelf availability of $ 412.3 million as of December 31, 2024.
+Added: In May 2024, we filed a Prospectus Supplement to the 2023 Shelf Registration Statement for the offering, issuance and sale of up to a maximum aggregate offering price of $ 80.0 million of common stock that may be issued and sold under an at-the-market sales agreement with Leerink Partners LLC as agent ("May 2024 ATM"), which rolls over the $ 80.0 million of unsold common stock from the May 2022 ATM.
+Added: We intend to use the net proceeds from the May 2024 ATM to continue to fund the ongoing clinical development of our product candidates and for other general corporate purposes, including funding existing and potential new clinical programs and product candidates.
The May 2024 ATM will terminate upon the earlier of (i) the issuance and sale of all of the shares through Leerink Partners LLC on the terms and subject to the conditions set forth in the May 2024 ATM or (ii) termination of the May 2024 ATM as otherwise permitted thereby.
−Removed: The May 2022 ATM may be terminated at any time by either party upon ten days’ prior notice, or by Leerink Partners LLC at any time in certain circumstances, including the occurrence of a material adverse effect on the Company.
+Added: The May 2024 ATM may be terminated at any time by either party upon ten days’ prior notice, or by Leerink Partners LLC at any time in certain circumstances, including the occurrence of a material adverse effect on us.
As of December 31, 2024, $ 80.0 million in capacity remains under the May 2024 ATM.
−Removed: The Company has agreed to pay Leerink Partners LLC a commission equal to 3.0 % of the gross proceeds from the sales of common shares pursuant to both ATM's and has agreed to provide Leerink Partners LLC with customary indemnification and contribution rights.
+Added: The Company has agreed to pay Leerink Partners LLC a commission equal to 3.0 % of the gross proceeds from the sales of common stock pursuant to the May 2024 ATM and has agreed to provide Leerink Partners LLC with customary indemnification and contribution rights.
+Added: For the year ended December 31, 2024, the Company raised gross proceeds of $ 0.2 million pursuant to the December 2020 ATM through the sale of 150,000 shares of common stock at a weighted average price of $ 1.31 per share.
+Added: The net proceeds from the December 2020 ATM were $ 0.2 million after deducting sales agent commissions of $ 6,000 .
For the year ended December 31, 2023, we raised gross proceeds of $ 0.9 million pursuant to the December 2020 ATM through the sale of 657,012 shares of common stock at a weighted average price of $ 1.34 per share.
The net proceeds from the December 2020 ATM were $ 0.9 million after deducting underwriter commissions of $ 26,000 .
−Removed: For the year ended December 31, 2022, the Company raised gross proceeds of $ 40.9 million pursuant to the December 2020 ATM through the sale of 4,204,113 shares of common stock at a weighted average price of $ 9.72 per share.
−Removed: The net proceeds from the December 2020 ATM were $ 39.6 million after deducting underwriter commissions of $ 1.2 million.
Equity Offerings
−Removed: Private Placement of up to $ 240 million
+Added: Private Placement of up to $ 240 million (the "January 2024 Financing")
On January 4, 2024, Immunic entered into a Securities Purchase Agreement with select accredited investors, pursuant to which the Company agreed to issue and sell to the Investors in a three -tranche private placement shares of the Company’s common stock, $ 0.0001 par value per share, or in lieu thereof, pre-funded warrants to purchase shares of Common Stock.
6 unchanged sentences
• The third tranche must occur no later than three years after the second tranche and is conditioned on the same volume-weighted average share price and minimum trading volumes as the second tranche.
−Removed: The third tranche provides for the issuance of $ 80 million of shares of common stock (or pre-funded warrants) at the same price per share as the second tranche, but permits investors to fund their purchase obligations on a “cashless” or net settlement basis, which would reduce the cash proceeds to be raised by the Company in the Private Placement.
+Added: The third tranche provides for the issuance of $ 80 million of shares of common stock (or pre-funded warrants) at the same price per share as the second tranche, but permits investors to fund their purchase obligations on a “cashless” or net settlement basis, which would reduce the cash proceeds to be raised by the Company in the January 2024 Financing.
Any of the conditions in the second or third tranches can be waived by holders of a majority of the outstanding securities (including the lead investor).
−Removed: The Private Placement resulted in gross proceeds to the Company of approximately $ 80 million in the first tranche, and an additional $ 80 million if and when the second tranche occurs.
−Removed: Assuming that the second tranche is completed and conditions for the third tranche are satisfied or waived, the Company could receive up to an additional $ 80 million in the third tranche.
−Removed: However, the amount of cash received in the third tranche would depend on the extent to which the Investors elect to fund the third tranche through a “cashless” or net settlement basis.
−Removed: Therefore, total gross proceeds from the offering to the Company could actually be between $ 80 million and $ 240 million.
−Removed: Gross proceeds to the Company will be reduced by fees paid to the placement agents, capital markets advisors and payments of transaction expenses.
−Removed: The Company intends to use the net proceeds from the Private Placement to fund the ongoing clinical development of its three lead product candidates, vidofludimus calcium (IMU-838), IMU-856 and IMU-381, and for other general corporate purposes
−Removed: $ 60 million Private Placement Equity Financing
−Removed: On October 10, 2022, Immunic entered into a Securities Purchase Agreement (the “Purchase Agreement”) for a private placement (the “Private Placement”) with select accredited investors and certain existing investors (each, a “Purchaser” and collectively, the “Purchasers”).
−Removed: Pursuant to the Purchase Agreement, the Company agreed to sell to the Purchasers (i) 8,696,552 shares of the Company’s common stock, par value $ 0.0001 per share (the “Shares”), at a purchase price of $ 4.35 per Share, and (ii) 5,096,552 pre-funded warrants (the “Pre-Funded Warrants”) to purchase Common Stock (the “Warrant Shares” and together with the Shares and the Pre-Funded Warrants, the “Securities”), at a purchase price of $ 4.34 per Pre-Funded Warrant.
−Removed: The Pre-Funded Warrants have an exercise price of $ 0.01 per share of Common Stock, be immediately exercisable and remain exercisable until exercised in full.
−Removed: The holders of Pre-Funded Warrants may not exercise a Pre-Funded Warrant if the holder, together with its affiliates, would beneficially own more than 9.99 % of the number of shares of Common Stock outstanding immediately after giving effect to such exercise.
−Removed: The holders of Pre-Funded Warrants may increase or decrease such percentages not in excess of 19.99 % by providing at least 61 days’ prior notice to the Company.
−Removed: The Pre-Funded Warrants are classified as a component of permanent equity because they are freestanding financial instruments that are legally detachable and separately exercisable from the shares of common stock with which they were issued, are immediately exercisable, do not embody an obligation for the Company to repurchase its shares, and permit the holders to receive a fixed number of shares of common stock upon exercise.
−Removed: In addition, the Pre-Funded Warrants do not provide any guarantee of value or return.
−Removed: All of the pre-funded warrants were exercised in January of 2023.
−Removed: The Private Placement closed on October 12, 2022.
−Removed: The gross proceeds of the Private Placement were approximately $ 60.0 million, before deducting offering expenses payable by the Company of approximately $ 4.0 million.
−Removed: The Company intends to use the net proceeds from the Private Placement to fund the ongoing clinical development of its three lead product candidates, vidofludimus calcium (IMU-838), izumerogant (IMU-935) and IMU-856, and for other general corporate purposes.
−Removed: The registration statement for these securities was deemed effective by Securities and Exchange Commission on December 20, 2022.
−Removed: As of December 31, 2022, the Company’s certificate of incorporation, as amended and restated, authorized the Company to issue 130,000,000 shares of common stock, par value of $ 0.0001 .
+Added: The fair value methodology used by the Company assumed the conditions will be waived if the trading price of the stock exceeds the purchase price.
+Added: The January 2024 Financing resulted in gross proceeds to the Company of approximately $ 80 million in the first tranche, and an additional $ 80 million if and when the second tranche occurs.
+Added: If the second tranche is completed and conditions for the third tranche are satisfied or waived, the Company could receive up to an additional $ 80 million in the third tranche.
+Added: As of the closing date of the transaction of January 8, 2024, the Company did not have enough authorized shares to be able to issue the potential shares for tranche 2 and tranche 3 (collectively referred to hereafter as "the tranche rights").
+Added: Therefore, the Company recorded the value associated to the tranche rights as a liability of $ 23.6 million and allocated the remainder of the $ 80 million received (or $ 56.4 million) with the common stock and pre-funded warrants to equity.
+Added: On March 4, 2024, the stockholders voted to increase the Company's authorized common stock from 130 million to 500 million shares.
+Added: As a result of the ability to issue shares in satisfaction of the tranche rights, the instrument was reclassified to stockholders' equity.
+Added: The Company allocated the transaction costs across the instruments on a relative fair value basis at the grant date.
+Added: As a result $ 4.0 million was netted against the equity proceeds and $ 1.7 million was recorded in other expense in the Consolidated Statements of Operations for year ended December 31, 2024.
+Added: The Company registered for resale by the investors in the January 2024 Financing up to 55,944,850 shares of common stock issued (or issuable upon exercise of pre-funded warrants) in the first tranche.
+Added: The Company will not receive any proceeds from the sale of these shares of common stock.
+Added: These shares are registered on a registration statement on Form S-3 (registration No.
+Added: On March 4, 2024, the stockholders of the Company voted to increase the authorized shares of the Company from 130,000,000 shares of common stock to 500,000,000 shares of common stock, par value of $ 0.0001 per share.
The voting, dividend and liquidation rights of the holders of the Company’s common stock are subject to and qualified by the rights, powers and preferences of any holders of preferred stock.
2 unchanged sentences
Through December 31, 2024, no cash dividends had been declared or paid.
−Removed: In a definitive proxy statement filed on February 5, 2024, for a special meeting of stockholders (the “Special Meeting”), the Company submitted a proposed amendment of Immunic’s amended and restated certificate of incorporation to increase the total number of authorized shares of common stock, $ 0.0001 par value per share, from 130,000,000 shares to 500,000,000 ;
−Removed: the Special Meeting date is set for March 4, 2024 with a record date of January 19, 2024.
+Added: Pre-funded Warrants
+Added: The Company issued 11,193,564 pre-funded warrants in connection with the January 2024 Financing, which all remain outstanding as of December 31, 2024.
Preferred Stock
−Removed: The Company’s certificate of incorporation, as amended and restated, authorizes the Company to issue 20,000,000 shares of $ 0.0001 par value preferred stock, rights and preferences to be set by the board of directors.
+Added: The Company’s certificate of incorporation, as amended and restated, authorizes the Company to issue 20 million shares of $ 0.0001 par value preferred stock, with such voting powers (if any), designations, powers, preferences, and relative, participating, optional or other rights, if any, and any qualifications, limitations or restrictions thereof, as shall be set by the Board of Directors.
No preferred shares were outstanding as of December 31, 2024.
3 unchanged sentences
2021 Employee stock purchase plan 928,158
+Added: Prefunded stock warrants 11,193,564
Outstanding stock options 16,136,045
+Added: Common shares reserved for tranche 2 rights 46,620,046
+Added: Maximum common shares reserved for tranche 3 rights 46,620,046
Common stock options available for future grant:
−Removed: 2014 Equity Incentive Plan 43,311
2017 Inducement Equity Incentive Plan 46,250
7 unchanged sentences
The purchase price of the stock is the lesser of (i) 85 % of the closing market price on the date of purchase and (ii) the closing market price at the beginning of the bi-annual offering period.
−Removed: The maximum number of shares reserved for delivery under the plan is 200,000 shares.
−Removed: This maximum number was increased by 1 million shares in September 2023, subject to approval by stockholders of the Company at the Company's Special Proxy meeting to be held on March 4, 2024.
+Added: The maximum number of shares initially reserved for delivery under the plan was 200,000 shares.
+Added: An increase of 1 million shares to 1.2 million shares was approved by stockholders of the Company at the Company's Special Meeting of stockholders held on March 4, 2024.
The first enrollment period under the plan commenced on August 1, 2021 and the Company has issued 271,842 shares life-to-date under the ESPP.
−Removed: The Company recognized $ 120,000 and $ 96,000 of expense related to the plan in the twelve months ended December 31, 2023 and 2022, respectively.
+Added: The Company recognized $ 50,000 and $ 120,000 of expense related to the plan in the years ended December 31, 2024 and 2023, respectively.
Stock Option Programs
−Removed: In July 2019, the Company’s stockholders approved the 2019 Omnibus Equity Incentive Plan, as amended on June 28, 2023 (the “2019 Plan”), which was adopted by the Board of Directors (the "Board") with an effective date of June 14, 2019.
+Added: In July 2019, the Company’s stockholders approved the 2019 Omnibus Equity Incentive Plan, (as amended, the “2019 Plan”), which was adopted by the Board of Directors (the "Board") with an effective date of June 14, 2019.
The 2019 Plan allows for the grant of equity awards to employees, consultants and non-employee directors.
3 unchanged sentences
At the Company's Annual Stockholders meeting on June 28, 2023, stockholders voted to increase the allowable shares under the 2019 plan by 4,440,000 shares as well as to eliminate the evergreen provision.
−Removed: The 2019 Plan is currently administered by the Board, or, at the discretion of the Board, by a committee of the Board, which determines the exercise prices, vesting schedules and other
−Removed: restrictions of awards under the 2019 Plan at its discretion.
+Added: On March 4, 2024, the stockholders voted at the Company's Special Meeting to increase the allowable shares under the 2019 plan by 9,100,000 .
+Added: The 2019 Plan (as amended on June 28, 2023 and March 4, 2024) is currently administered by the Board, or, at the discretion of the Board, by a committee of the Board, which determines the exercise prices, vesting schedules and other restrictions of awards under the 2019 Plan at its discretion.
Options to purchase stock may not have an exercise price that is less than the fair market value of underlying shares on the date of grant, and may not have a term greater than ten years .
2 unchanged sentences
Shares that are expired, terminated, surrendered or canceled under the 2019 Plan without having been fully exercised will be available for future awards.
+Added: Stock Option Repricing
+Added: On March 4, 2024, the Company's stockholders voted to approve the repricing of outstanding stock options having an exercise price above $ 3.00 per share to $ 1.72 per share.
+Added: All other terms of the grant remained the same.
+Added: There were 3,317,596 stock options that were repriced to $ 1.72 per share.
+Added: The repricing will result in $ 1.2 million of stock compensation being recognized by the Company over the remaining term of the repriced grants and $ 1.1 million of this amount was recognized in the year ended December 31, 2024.
Movements during the year
−Removed: The following table summarizes stock option activity for the twelve months ended December 31, 2023 and 2022 under the 2019 Plan:
+Added: The following table summarizes stock option activity for the year ended December 31, 2024 and 2023 under the 2019 Plan:
Options Weighted-
4 unchanged sentences
Exercised — $ —
+Added: Repricing modification — $ 9.55
Forfeited or expired ( 405,693 ) $ 2.05
40 unchanged sentences
All awards granted under these plans have either been forfeited or expired.
−Removed: There remains 43,311 shares available for grant under the 2014 Plan as of December 31, 2023.
+Added: There are no longer any shares available for grant under the 2014 Plan as of December 31, 2024.
On September 2017, Vital’s board of directors approved the Inducement Plan, which was amended and restated in November 2017.
Under the Inducement Plan 46,250 shares of Vital’s common stock were reserved to be used exclusively for non-qualified grants to individuals who were not previously employees or directors as an inducement material to a grantee's entry into employment within the meaning of Rule 5635(c)(4) of the Nasdaq Listing Rules.
−Removed: No expense was recorded for the plans assumed from Vital during the twelve months ended December 31, 2023 and 2022, respectively.
+Added: No expense was recorded for the plans assumed from Vital during the year ended December 31, 2024 and 2023, respectively.
Net loss before income tax was subject to tax in the following jurisdictions for the following periods (in thousands):
9 unchanged sentences
Stock options ( 1.4 ) % ( 1.2 ) %
−Removed: Tax effect of rate change 0.0 % 0.0 %
−Removed: Goodwill impairment 0.0 % ( 5.7 ) %
+Added: Deferred tax true-up ( 2.5 ) % 0.0 %
+Added: Stock and warrant issuance cost ( 1.4 ) % 0.0 %
Other ( 0.9 ) % 1.2 %
44 unchanged sentences
There were no such interest or penalties for any of the years presented.
−Removed: Changes in Board of Directors
−Removed: Appointment of Richard Rudick, M.D.
−Removed: to Board of Directors
−Removed: On April 27, 2023, the Company announced the appointment of Dr.
−Removed: Richard Rudick as a member of the Board of Directors, effective as of April 26, 2023.
−Removed: As a Class III director, Dr.
−Removed: Rudick’s initial term lasted until the 2023 Annual Meeting of Stockholders held on June 28, 2023, at which meeting he was elected to a three years term expiring at the 2026 Annual Meeting of Stockholders.
−Removed: Director Resignation
−Removed: Vincent Ossipow retired from the Board of Directors on June 28, 2023.
−Removed: Ossipow’s decision not to stand for re-election was not the result of any disagreement with the Company or its management on any matter relating to the Company’s operations, policies or practices.
+Added: Commitments and Contingencies
+Added: Contractual Obligations
+Added: As of December 31, 2024, the Company has non-cancelable contractual obligations under certain agreements related to its development programs in vidofludimus calcium and IMU-856 totaling approximately $ 2.4 million, the majority of which is expected to be paid by the end of 2026.
+Added: Other Commitments and Obligations
+Added: Daiichi Sankyo Agreement
+Added: On January 5, 2020, the Company exercised its option to obtain the exclusive worldwide right to commercialization of IMU-856.
+Added: Among other things, the option exercise grants Immunic AG the rights to Daiichi Sankyo’s patent application related to IMU-856, for which the Company received a notice of allowance from the U.S.
+Added: Patent & Trademark Office in August 2022.
+Added: In connection with the option exercise, the Company paid a one-time upfront licensing fee to Daiichi Sankyo.
+Added: Under the Daiichi Sankyo Agreement, Daiichi Sankyo is also eligible to receive future development, regulatory and sales milestone payments, as well as royalties related to IMU-856.
+Added: Legal Proceedings
+Added: The Company is not currently a party to any litigation, nor is it aware of any pending or threatened litigation, that it believes would materially affect its business, operating results, financial condition or cash flows.
+Added: However, its industry is characterized by frequent claims and litigation including securities litigation, claims regarding patent and other intellectual property rights and claims for product liability.
+Added: As a result, in the future, the Company may be involved in various legal proceedings from time to time.
Related Party Transactions
−Removed: Executive Chairman Agreement with Duane Nash
+Added: Executive Agreement with Duane Nash
On April 15, 2020, the compensation committee of the Board of Directors of the Company independently reviewed and approved entering into an employment agreement with the Executive Chairman of the Board, Duane Nash, MD, JD, MBA (the “Executive Chairman Agreement”) and pursuant to such approval, on April 17, 2020, the Company and Dr.
5 unchanged sentences
On October 17, 2023, Immunic, Inc.
−Removed: Duane Nash entered into Addendum Number 5 to the Employment Agreement dated April 17, 2020, as amended as of October 15, 2020, April 15, 2021, March 15, 2022, and December 28, 2022, to extend the term of Dr.
+Added: Duane Nash entered into Addendum Number 5 to the Executive Chairman Agreement to extend the term of Dr.
Nash’s employment as Executive Chairman of the Board of Directors of the Company to December 31, 2024.
−Removed: In connection with the Addendum, the Company increased Dr.
+Added: In connection with Addendum Number 5, the Company increased Dr.
Nash’s monthly base salary to $ 32,368 from $ 30,250 (which includes the cash retainer payable for serving on the Company’s Board or for acting as the Chairman of the Board).
−Removed: All other terms of the Executive Chairman Agreement remain the same.
+Added: On August 29, 2024, Immunic, Inc.
+Added: Duane Nash entered into Addendum Number 6 to the Executive Chairman Agreement to extend the term of Dr.
+Added: Nash’s employment as Executive Chairman of the Board of Directors of the Company to December 31, 2025.
+Added: In connection with Addendum Number 6, the Company will increase Dr.
+Added: Nash’s monthly base salary in 2025 to $ 33,986 from $ 32,368 (which includes the cash retainer payable for serving on the Company’s Board or for acting as the Chairman of the Board) All other terms of the Executive Chairman Agreement remain the same.
+Added: Segment disclosures
+Added: Operating segments are defined as components of an enterprise about which separate discrete information is available for evaluation by the chief operating decision maker, or decision making group, in deciding how to allocate resources in assessing performance.
+Added: The Company has one reportable segment:
+Added: life science.
+Added: The life science segment consists of the development of clinical and preclinical product candidates for the development of the Company’s proprietary new therapies.
+Added: The Company’s chief operating decision maker (“CODM”) is the chief executive officer.
+Added: The accounting policies of the life science segment are the same as those described in the summary of significant accounting policies.
+Added: The CODM assesses performance for the life science segment based on net loss.
+Added: The measure of segment assets is reported on the balance sheet as total consolidated assets.
+Added: The CODM allocates resources and assesses performance on a consolidated basis, focused on the Company’s cash resources and an assessment of the probability of success of its ongoing research and development activities.
+Added: Resource allocation decisions are informed by forecasted cash expenditures and actual expenses incurred to date.
+Added: To date, the Company has not generated any product revenue.
+Added: The Company expects to continue to incur significant expenses and operating losses for the foreseeable future as it advances product candidates through all stages of development and clinical trials and, ultimately, seek regulatory approval.
+Added: The table below summarizes the significant expense categories regularly reviewed by the CODM for the years ended December 31:
+Added: Years ended December 31
+Added: Operating expenses:
+Added: Clinical product candidates $ 65,285 $ 68,999
+Added: Pre-clinical product candidates 979 1,995
+Added: Employee costs- research and development 7,854 6,917
+Added: Employee costs-general and administrative 5,315 4,478
+Added: Non-cash stock compensation 8,527 7,102
+Added: Depreciation expense 134 111
+Added: Professional fees and other segment expenses 9,958 9,621
+Added: Total operating expenses 98,052 99,223
+Added: Loss from operations ( 98,052 ) ( 99,223 )
+Added: Interest Income 3,390 3,075
+Added: Change in fair value of the tranche rights ( 4,796 ) —
+Added: Other income (expense) ( 1,049 ) 2,536
+Added: Net loss $ ( 100,507 ) $ ( 93,612 )
Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the registrant has duly caused this Annual Report on Form 10-K to be signed on its behalf by the undersigned, thereunto duly authorized.
Immunic, Inc.
−Removed: February 22, 2024 By:
+Added: March 31, 2025 By:
/s/ DANIEL VITT
4 unchanged sentences
Signature Title Date
−Removed: /s/ DANIEL VITT Director, Chief Executive Officer and President February 22, 2024
−Removed: /s/ GLENN WHALEY Chief Financial Officer February 22, 2024
−Removed: NASH Executive Chairman February 22, 2024
−Removed: /s/ TAMAR HOWSON Director February 22, 2024
−Removed: /s/ JOERG NEERMANN Director February 22, 2024
+Added: /s/ DANIEL VITT Director, Chief Executive Officer (principal executive officer) March 31, 2025
+Added: /s/ GLENN WHALEY Chief Financial Officer (principal financial officer and principal accounting officer) March 31, 2025
+Added: NASH Executive Chairman March 31, 2025
+Added: /s/ TAMAR HOWSON Director March 31, 2025
+Added: /s/ JOERG NEERMANN Director March 31, 2025
Joerg Neermann
−Removed: /s/ RICHARD RUDICK Director February 22, 2024
+Added: /s/ RICHARD RUDICK Director March 31, 2025
Richard Rudick
/s/ BARCLAY A.
−Removed: PHILLIPS Director February 22, 2024
−Removed: /s/ MARIA TORNSEN Director February 22, 2024
+Added: PHILLIPS Director March 31, 2025
+Added: /s/ SIMONA SKERJANEC Director March 31, 2025
Maria Tornsen
+Added: /s/ MARIA TORNSEN Director March 31, 2025
+Added: Maria Tornsen
Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.