What changed in this filing

/stocks — the workspaceLOADING

Item 9A. Controls and Procedures

2024-02-22 compared with 2023-02-23 · 158 added, 218 removed, 682 unchanged (36% of the section changed)

50 unchanged sentences

Exhibit Title Form Exhibit Filing Date

3.1 Amended and Restated Articles of Incorporation.

3.1 Amended and Restated Certificate of Incorporation.

8-K 3.1 July 17, 2019

1 unchanged sentence

8-K 3.1 July 17, 2019

4.1 2019 Omnibus Equity Incentive Plan.

S-8 4.1 September 20, 2019

4.1 2019 Omnibus Equity Incentive Plan, as amended ,

S-8 4.2 August 21, 2023

4.2+ Amended and Restated 2021 Employee Stock Purchase Plan.

S-8 10.3 July 28, 2021

4.3* Description of Registrant’s Securities

8-K 4.2 February 26, 2020

4.4 Form of Pre-Funded Warrant

8-K 4.1 January 4, 2024

10.1 Addendum No.

5, dated October 17, 2023, to Employment Agreement, dated April 17, 2020, between Immunic, Inc.

and Duane Nash.

8-K 10.1 October 17, 2023

10.1 Sales Agreement, dated July 17, 2019, between Immunic, Inc.

and SVB Leerink LLC.

8-K 10.1 July 17, 2019

10.2 Option and License Agreement, dated September 27, 2018, between Immunic AG and Daiichi Sankyo Company, Ltd.

8-K 10.2 July 17, 2019

10.3 Asset Purchase Agreement, dated May 13, 2016, between Immunic AG and 4SC AG.

8-K 10.3 July 17, 2019

10.2 Employment Agreement, dated December 18, 2023, between Immunic, Inc.

Andreas Muehler.

8-K 10.3 December 18, 2023

10.3 F ifth Addendum, dated December 18, 2023, to Service Agreement between Immunic AG and Dr.

8-K 10.1 December 18, 2023

10.4 Fifth Addendum, dated December 18, 2023, to Service Agreement between Immunic AG and Dr.

Andreas Muehler.

8-K 10.2 December 18, 2023

10.5 Fifth Addendum, dated December 18, 2023, to Service Agreement between Immunic AG and Dr.

Hella Kohlhof.

8-K 10.4 December 18, 2023

10.6 Securities Purchase Agreement, dated January 4, 2024, by and among the Company and the Investors.

8-K 10.1 January 4, 2024

10.7 Form of Indemnification Agreement.

2 unchanged sentences

Andreas Muehler.

10-K 10.5 February 23, 2023

10.9 Service Agreement, dated September 29, 2016, between Immunic AG and Daniel Vitt.

10-K 10.6 February 23, 2023

10.10 Employment Agreement between Dr.

1 unchanged sentence

8-K 10.5 July 17, 2019

10.8+ Addendum to Service Agreement between Immunic AG and Dr.

8-K 10.1 September 5, 2019

10.11 Employment Agreement, dated September 4, 2019, between Immunic, Inc.

1 unchanged sentence

8-K 99.3 September 5, 2019

10.10+ Addendum, dated September 4, 2019, to Service Agreement between Immunic AG and Dr.

Andreas Muehler.

8-K 99.2 September 5, 2019

10.11+ Addendum, dated September 4, 2019, to Service Agreement between Immunic AG and Dr.

Hella Kohlhof.

8-K 99.4 September 5, 2019

10.12 Employment Agreement dated April 17, 2020, between Immunic, Inc.

1 unchanged sentence

8-K 10.2 April 20, 2020

10.13 Second Addendum to Employment Agreement dated October 15, 2020, between Immunic, Inc.

and Duane Nash.

8-K 10.1 April 19, 2021

10.14 Placement Agency Agreement, dated April 23, 2020, between Immunic, Inc.

and Roth Capital Partners, LLC

8-K 10.1 April 20, 2020

10.15 Form of Securities Purchase Agreement, dated April 23, 2020, between Immunic, Inc.

and the investors party thereto.

8-K 10.2 April 20, 2020

10.16 Placement Agency Agreement, dated June 10, 2020, between Immunic, Inc.

and the Roth Partners, LLC

8-K 10.1 June 12, 2020

10.17 Form of Securities Purchase Agreement, dated June 10, 2020, between Immunic, Inc.

and the investors party thereto

8-K 10.2 June 12, 2020

10.18 Underwriting Agreement, dated August 4, 2020, by and between Immunic, Inc.

and SVB Leerink LLC.

8-K 1.1 August 10, 2020

10.19 Finance Contract, dated October 19, 2020, between Immunic, Inc., Immunic AG and European Investment Bank

8-K 10.1 October 20, 2020

10.20 Form of Guarantee Agreement between Immunic, Inc., Immunic AG and European Investment Bank.

8-K 10.2 October 20, 2020

10.21+ Sales Agreement, dated December 29, 2020 between Immunic, Inc.

and SVB Leerink LLC

8-K 10.1 January 4, 2021

10.22+ Amendment Letter, dated November 11, 2020

8-K 10.1 November 13, 2020

10.23+ Settlement Agreement, dated March 31, 2021, between Immunic AG and 4SC AG.

8-K 10.1 March 31, 2021

10.24+ Addendum No.

2 to Employment Agreement dated April 15, 2021 between Immunic, Inc.

and Duane Nash

8-K 10.1 April 15, 2021

10.25+ Second Addendum to Service Agreement between Immunic AG and Dr.

8-K 10.1 June 10, 2021

10.26+ Second Addendum, dated June 10, 2021 to Service Agreement between Immunic AG and Dr.

Andreas Muehler

8-K 10.2 June 10, 2021

10.13 Employment Agreement, dated June 10, 2021 between Immunic, Inc.

4 unchanged sentences

8-K 10.4 June 10, 2021

10.29+ Second Addendum, dated June 10, 2021, to Service Agreement between Immunic AG and Dr.

Hella Kohlhof

8-K 99.2 June 10, 2021

10.30+ Underwriting Agreement, dated July 15, 2021, by and between Immunic, Inc.

and Piper Sandler & Co

8-K 1.1 July 15, 2021

10.15 Employment Agreement, dated October 14, 2021, between Immunic, Inc.

1 unchanged sentence

8-K 10.1 October 14, 2021

10.32+ Third Addendum, dated January 5, 2022, to Service Agreement between Immunic AG and Dr.

8-K 10.1 January 10, 2022

10.33+ Third Addendum, dated January 5, 2022, to Service Agreement between Immunic AG and Dr.

Andreas Muehler

8-K 10.2 January 10, 2022

10.34+ Third Addendum, dated January 5, 2022, to Service Agreement between Immunic AG and Dr.

Hella Kohlhof

8-K 10.3 January 10, 2022

10.35+ Addendum No.

3 to Employment Agreement, dated March 15, 2022, between Immunic, Inc.

and Duane Nash

8-K 10.1 March 15, 2022

10.36 Sales Agreement dated as of May 2, 2022, between SVB Securities LLC and Immunic, Inc.

8-K 10.1 May 2, 2022

10.37 Securities Purchase Agreement, dated October 10, 2022, by and among the Company and the Purchasers

8-K 10.1 October 11, 2022

10.38+ Addendum No.

4 dated December 28, 2022 to Employment Agreement, between Immunic, Inc.

and Duane Nash

8-K 10.1 December 30, 2022

10.39+ Fourth Addendum dated January 16, 2023 to the Service Agreement, between Immunic AG and Dr.

8-K 10.1 January 16, 2023

10.40+ Fourth Addendum dated January 16, 2023 to the Service Agreement, between Immunic AG and Dr.

Andreas Muehler

8-K 10.2 January 16, 2023

10.41+ Fourth Addendum dated January 16, 2023 to the Service Agreement, between Immunic AG and Dr.

Hella Kohlhof

8-K 10.3 January 16, 2023

19* Immunic, Inc.

Insider Trading Policy.

21.1 List of subsidiaries of the Registrant

8 unchanged sentences

Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.

97* Immunic, Inc.

Clawback Policy.

101.INS* XBRL Instance Document

6 unchanged sentences

+ Indicates a management contract or compensatory plan or arrangement.

* Filed herewith

** In accordance with Item 601(b)(32)(ii) of Regulation S-K and SEC Release No.

33-8238 and 34-47986, Final Rule:

Management’s Reports on Internal Control Over Financial Reporting and Certification of Disclosure in Exchange Act Periodic Reports, the certifications furnished in Exhibits 32.1 and 32.2 hereto are deemed to accompany this Form 10-K and will not be deemed “filed” for purposes of Section 18 of the Exchange Act.

Management’s Reports on Internal Control Over Financial Reporting and Certification of Disclosure in Exchange Act Periodic Reports, the certifications furnished in Exhibits 32.1 and 32.2 hereto are deemed to accompany this Form 10-Q and will not be deemed “filed” for purposes of Section 18 of the Exchange Act.

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.

1 unchanged sentence

INDEX TO CONSOLIDATED FINANCIAL STATEMENTS

Report of Baker Tilly U S LLP, Independent Registered Public Accounting Firm (PCAOB ID 23 )

Report of Baker Tilly US LLP, Independent Registered Public Accounting Firm (PCAOB ID 23 )

Consolidated Balance Sheets

50 unchanged sentences

Investments - other — 9,629

Other current assets and prepaid expenses 9,490 18,125

Prepaid expenses and other current assets 5,860 9,490

Total current assets 52,534 125,864

Property and equipment, net 466 294

Goodwill (note 2) — 32,970

Right of use asset, net 1,299 1,552

18 unchanged sentences

Additional paid-in capital 436,060 427,925

Accumulated other comprehensive income (loss) 3,035 ( 252 )

Accumulated other comprehensive income 3,759 3,035

Accumulated deficit ( 410,892 ) ( 317,280 )

10 unchanged sentences

Goodwill impairment (see Note 2) — 32,970

4SC Royalty Settlement (See Note 4) — 17,250

Total operating expenses 99,223 119,488

2 unchanged sentences

Interest income 3,075 1,041

Other expense, net ( 1,960 ) ( 1,346 )

Total other expense, net ( 919 ) ( 1,280 )

Other income (expense), net 2,536 ( 1,960 )

Total other income (expense), net 5,611 ( 919 )

Net loss $ ( 93,612 ) $ ( 120,407 )

24 unchanged sentences

Stock-based compensation — — 7,929 — — 7,929

Issuance of common stock - July 2021 equity offering net of issuance costs of $ 2,980

Issuance of common stock and Pre-funded Warrants - October 2022 PIPE transaction, net of issuance costs of $ 4,012

8,696,552 1 55,988 — — 55,989

2 unchanged sentences

Shares issued in connection with the Company's employee stock purchase plan 70,351 — 182 — — 182

Issuance of common stock in connection with the 4SC royalty settlement (see note 4) 581,199 — 8,625 — — 8,625

Shares issued in connection with the Company's stock option plan 852 — 5 — — 5

Balance at December 31, 2022 39,307,286 4 $ 427,925 $ 3,035 $ ( 317,280 ) $ 113,684

2 unchanged sentences

Stock-based compensation — — 7,102 — — 7,102

Issuance of common stock and Pre-funded Warrants - October 2022 PIPE transaction, net of issuance costs of $ 4,012

8,696,552 1 55,988 — — 55,989

Shares issued from 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

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

11 unchanged sentences

Foreign currency loss 523 4,757

Common stock issued in connection with the 4SC royalty settlement (see Note 4) — 8,625

Changes in operating assets and liabilities:

Prepaid expenses and other assets 7,493 ( 12,800 )

Prepaid expenses and other current assets 3,858 7,493

Accounts payable 817 799

3 unchanged sentences

Cash flows from investing activities:

Purchases of Investments-other ( 9,629 ) —

(Purchases) sales of Investments-other 9,796 ( 9,629 )

Purchases of property and equipment ( 334 ) ( 112 )

Net cash used in investing activities ( 9,741 ) ( 67 )

Net cash provided by (used in) investing activities 9,462 ( 9,741 )

Cash flows from financing activities:

3 unchanged sentences

Proceeds from the exercise of stock options — 5

Proceeds from July 2021 public equity offering, net of issuance costs of $ 2,980

Proceeds from the exercise of pre-funded warrants 51 —

Net cash provided by financing activities 1,033 95,760

4 unchanged sentences

Supplemental disclosure of noncash investing and financing activities:

Common stock issued in connection with the 4SC royalty settlement (see Note 4) $ — $ 8,625

Operating lease right-of use asset obtained in exchange for lease obligation $ 544 $ 974

4 unchanged sentences

Immunic, Inc.

("Immunic" or the "Company") is a clinical-stage biopharmaceutical company with a pipeline of selective oral immunology therapies focused on treating chronic inflammatory and autoimmune diseases.

("Immunic" or the "Company") is a biotechnology company developing a clinical pipeline of selective oral immunology therapies focused on treating chronic inflammatory and autoimmune diseases.

The Company is headquartered in New York City with its main operations in Gräfelfing near Munich, Germany.

The Company currently has approximately 66 employees.

The Company is currently pursuing clinical development of three 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.

These include the vidofludimus calcium (IMU-838) program, which is in Phase 3 clinical development for patients with multiple sclerosis (“MS”);

the izumerogant (proposed International Nonproprietary Name (“INN”) for IMU-935) program, which is an inverse agonist of retinoic acid receptor-related orphan nuclear receptor gamma truncated (“RORγt”) that inhibits the interleukin-17 (“IL-17”) pathway in diseases such as psoriasis;

and the IMU-856 program, which is targeted to restore intestinal barrier function and regenerate bowel epithelium.

The Company had 77 employees as of February 1, 2024.

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.

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;

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;

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.

3 unchanged sentences

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.

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.

From inception through December 31, 2022, Immunic has raised net cash of approximately $ 355.5 million from private and public offerings of preferred and common stock.

As of December 31, 2022, the Company had cash and cash equivalents of approximately $ 106.7 million and investments - other of $ 9.6 million.

With these funds the Company expects to be able to fund its operations beyond twelve months from the date of the issuance of the accompanying financial statements.

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.

As of December 31, 2023, the Company had cash and cash equivalents of approximately $ 46.7 million.

On January 4, 2024, we raised net cash proceeds in a private placement of approximately $ 75.0 million.

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.

Basis of Presentation and Consolidation

The accompanying consolidated financial statements have been prepared in conformity with United States generally accepted accounting principles, ("U.S.

GAAP") and include the accounts of Immunic and its wholly-owned subsidiaries, Immunic AG (which began operations in 2016) and Immunic Australia Pty Ltd.

(which began operations in 2018).

GAAP") and include the accounts of Immunic and its wholly-owned subsidiaries, Immunic AG and Immunic Australia Pty Ltd.

All intercompany accounts and transactions have been eliminated in consolidation.

4 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.

The most significant estimates in the Company’s financial statements and accompanying notes relate to recoverability of goodwill, clinical trial expenses and share-based compensation.

The most significant estimates in the Company’s financial statements and accompanying notes relate to clinical trial expenses and share-based compensation.

Management believes its estimates to be reasonable under the circumstances.

18 unchanged sentences

Time Deposits with an original maturity greater than three months are classified as Investments - other.

Cash and cash equivalents consist of cash on hand and deposits in banks located in the U.S of approximately $ 85.7 million, Germany of approximately $ 19.1 million and Australia of approximately $ 1.9 million.

Cash and cash equivalents and investments - other consist of cash on hand and deposits in banks located in the U.S.

of approximately $ 34.4 million, Germany of approximately $ 10.4 million and Australia of approximately $ 1.9 million as of December 31, 2023.

The Company maintains cash and cash equivalent balances denominated in Euro and U.S.

1 unchanged sentence

and Germany in excess of the deposit limits insured by the government.

Management periodically reviews the credit standing of these financial institutions and believes that the Company is not exposed to any significant credit risk.

Management periodically reviews the credit standing of these financial institutions.

The Company currently deposits its cash and cash equivalents with two large financial institutions.

Our Cash and Cash equivalents in the U.S.

is primarily held in a U.S.

Government money market fund account and was earning interest at a rate of 4.3 %.

Our cash and cash equivalents in Germany and Australia were earning interest at a rate of — % to 0.87 %

Cash and Cash equivalents in the U.S.

are held at J.P.

Morgan and as of December 31, 2023 are primarily held in a U.S.

Government money market fund account earning interest at a rate of 5.2 %.

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.

Investments - other consists of the following as of (in thousands):

1 unchanged sentence

Time Deposits $ 0 $ 9,629

The time deposit accounts are held in our bank in Germany and are held in Euros and are earning interest at a rate of 0.61 % to 0.87 % and have a remaining maturity 3 - 4 months.

Fair Value Measurement

26 unchanged sentences

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.

On October 20, 2022, the Company announced the outcome of a significant interim analysis of its Phase 1b clinical trial of izumerogant in patients with moderate-to-severe psoriasis that were not deemed positive progress.

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.

On October 21, 2022, the Company experienced a significant decrease in the Company's market capitalization.

2 unchanged sentences

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.

The Company did not have any goodwill impairment during the year ended December 31, 2021.

The changes in the carrying amount of goodwill for the years presented are as follows (amounts in thousands):

Carrying amount of goodwill at December 31, 2021 $ 32,970

Impairment of goodwill during the year ended December 31, 2022 ( 32,970 )

Carrying amount of goodwill at December 31, 2022 $ —

Research and Development Expenses

These costs primarily include external development expenses and internal personnel expenses for the three development programs, vidofludimus calcium, izumerogant 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 RRMS, UC and COVID-19.

These costs primarily include external development expenses and internal personnel expenses for its development programs, vidofludimus calcium, izumerogant 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.

Research and development expenses consist of expenses incurred in research and development activities, which include clinical trials, contract research services, certain milestone payments, salaries and related employee benefits, allocated facility costs and other outsourced services.

6 unchanged sentences

non-refundable or partially refundable upfront or license fees;

development, regulatory and commercial milestone payments;

development, regulatory and commercial milestone

payment for manufacturing supply services;

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On January 5, 2020, the Company exercised its option to obtain the exclusive worldwide right to commercialization of IMU-856.

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 US Patent & Trademark Office in August 2022.

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.

Patent & Trademark Office in August 2022.

In connection with the option exercise, the Company paid a one-time upfront licensing fee to Daiichi Sankyo.

2 unchanged sentences

Government assistance relating to research and development performed by Immunic Australia is recorded as a component of other (income) expense.

Government assistance is recognized at a rate of 43.5 % of the qualified research and development expenditures which are incurred.

We recognized $ 2.3 million and $ 1.7 million of other income related to research activities performed during the years ended December 31, 2022 and 2021, respectively.

This government assistance is recognized at a rate of 43.5 % of the qualified research and development expenditures which are incurred.

We also receive government assistance from the German Government for reimbursement of research and development expenses up to one million Euros per year.

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.

General and Administrative Expenses

6 unchanged sentences

The Company estimates the fair value of stock options using the Black-Scholes-Merton option-pricing model ("BSM"), which requires the use of estimates and subjective assumptions, including the risk-free interest rate, the fair value of the underlying common stock, the expected dividend yield of the Company’s common stock, the expected volatility of the price of the Company’s common stock, and the expected term of the option.

These estimates involve inherent uncertainties and the

application of management’s judgment.

These estimates involve inherent uncertainties and the application of management’s judgment.

If factors change and different assumptions are used, the Company’s stock-based compensation expense could be materially different in the future.

2 unchanged sentences

Leases with terms of 12 months or less at inception are not included in the operating lease right of use asset and operating lease liability.

The Company has two existing leases for office space.

The Company has three existing leases for office and laboratory space.

At inception of a lease agreement, the Company determines whether an agreement represents a lease and at commencement each lease agreement is assessed as to classification as an operating or financing lease.

The Company's two leases have been classified as operating leases and an operating lease right-of-use asset and an operating lease liability have been recorded on the Company’s balance sheet.

The Company's leases have been classified as operating leases and an operating lease right-of-use asset and an operating lease liability have been recorded on the Company’s balance sheet.

A right-of-use lease asset represents the Company’s right to use the underlying asset for the lease term and the lease obligation represents its commitment to make the lease payments arising from the lease.

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The Company is not currently under examination by any tax jurisdictions.

for Derivative Financial Instruments Indexed to, and Potentially Settled in, a Company’s Own Stock (“ASC 815-40”).

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”).

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.

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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.

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 whether the warrants are classified as equity under ASC 815-40 or other applicable GAAP standard.

whether the warrants are classified as equity under ASC 815-40 or other applicable GAAP standard.

Equity-classified warrants are accounted for at fair value on the issuance date with no changes in fair value recognized after the issuance date.

16 unchanged sentences

Australian research and development tax incentive 670 2,361

Research grant 1,104 —

Other 1,069 1,225

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The Company leases certain office space under non-cancelable operating leases.

The leases terminate on July 31, 2025 for the New York City office and June 30, 2025 for the Gräfelfing, Germany office.

The Company formerly leased office space in

Planegg-Martinsried, Germany pursuant to a modified lease that terminated on August 31, 2020.

These leases include both lease (e.g., fixed rent) and non-lease components (e.g., common-area and other maintenance costs).

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.

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.

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Renewal options were not included in calculating the right of use asset and liabilities for this facility.

In February 2023, the Company leased space in Germany for a research laboratory.

The leases do not have concessions, leasehold improvement incentives or other build-out clauses.

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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.

There were net additions to right of use assets of $ 435,000 and $ 642,000 as a result of signing for additional lease space at the Gräfelfing, Germany office in March 2021 and August 2022, respectively.

There were net additions to right of use assets of $ 332,000 as a result of extending the New York City lease in December 2022.

There were net additions of $ 544,000 related to the addition of new laboratory space in Planegg, Germany in February 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.

Therefore, the Company estimated its incremental interest rate to be 6 % for the original leases and 8 % for the New York City extension, considering the quoted rates for the lowest investment-grade debt and the interest rates implicit in recent financing leases.

Therefore, the Company estimated its incremental interest rate to be 6 % for the original leases and 8 % for the New York City extension and German laboratory, considering the quoted rates for the lowest investment-grade debt and the interest rates implicit in recent financing leases.

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.

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Other Commitments and Obligations

In May 2016, the Company entered into a purchase agreement (the “Agreement”) with 4SC AG, whereby the Company acquired certain assets, including the rights to patents and patent applications, trademarks and know-how.

This transaction has been accounted for as an asset acquisition under Accounting Standards Update 2017-01 - Business Combinations (Topic 805):

Clarifying the Definition of a Business.

The Agreement included payments (Tranches III and IV) that were contingent upon the occurrence of certain events and required the Company to pay royalties equal to 4.4 % of the aggregated net sales for a certain period as defined in the Agreement (Tranche III) upon commercialization of the acquired assets.

Effective April 12, 2019, the parties agreed to settle Tranche IV by issuing 120,070 shares of the Company’s common stock, immediately following the Transaction, to 4SC AG while keeping Tranche III in effect.

Approximately $ 1.5 million of expense was recorded as a result of the issuance of these shares on April 12, 2019.

On March 31, 2021, Immunic AG, a wholly-owned subsidiary of the Company, and 4SC AG entered into a Settlement Agreement, pursuant to which Immunic AG settled its remaining obligation of the 4.4 % royalty on net sales for $ 17.25 million

(Tranche III of the Agreement).

The payment was made 50 % in cash and 50 % in shares of Immunic’s common stock (the “Shares”).

Pursuant to the Agreement, the Company filed a resale shelf registration statement on Form S-3 covering the resale of the Shares.

With the execution of the Agreement, no further payment obligations remain between Immunic AG and 4SC AG.

Daiichi Sankyo Agreement

On January 5, 2020, the Company exercised its option to obtain the exclusive worldwide right to commercialization of IMU-856.

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.

Patent & Trademark Office in August 2022.

In connection with the option exercise, the Company paid a one-time upfront licensing fee to Daiichi Sankyo.

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.

Legal Proceedings

20 unchanged sentences

The fair value and book value of the money market funds presented in the table above are the same.

For the assessment of the fair value of goodwill and the related impairment of goodwill we used a level one assessment in our testing of goodwill.

See Note 2, Summary of significant accounting policies "Goodwill".

Shelf Registration Statements

In November 2020, Immunic filed a shelf registration statement on Form S-3.

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.

As of February 17, 2023, there is $ 75.0 million remaining on this shelf registration statement

In December 2020, the Company 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 ("December 2020 ATM") with SVB Leerink as agent.

The Company has used, and intends to continue 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.

The December 2020 ATM will terminate upon the earlier of (i) the issuance and sale of all of the shares through SVB Leerink 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.

The December 2020 ATM may be terminated at any time by either party upon ten days’ prior notice, or by SVB Leerink at any time in certain circumstances, including the occurrence of a material adverse effect on the Company.

As of February 17, 2023, $ 8.4 million in capacity remains under the December 2020 ATM.

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 SVB Leerink as agent.

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;

and (ii) offer and sell additional securities to be registered on the new Form S-3.

In November 2020, we filed a shelf registration statement on Form S-3 (the "2020 Shelf Registration Statement").

The 2020 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.

As of December 31, 2024, there is $ 75.0 million remaining on this shelf registration statement.

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").

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.

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.

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.

As of December 31, 2024, $ 7.5 million in capacity remains under the December 2020 ATM.

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.

The May 2022 ATM will terminate upon the earlier of (i) the issuance and sale of all of the shares through SVB Leerink on the terms and subject to the conditions set forth in the May 2022 ATM or (ii) termination of the May 2022 ATM as otherwise permitted thereby.

The May 2022 ATM may be terminated at any time by either party upon ten days’ prior notice, or by SVB Leerink at any time in certain circumstances, including the occurrence of a material adverse effect on the Company.

As of February 17, 2023, $ 80.0 million in capacity remains under the May 2022 ATM.

The Company has agreed to pay SVB Leerink 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 SVB Leerink with customary indemnification and contribution rights.

The May 2022 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 2022 ATM or (ii) termination of the May 2022 ATM as otherwise permitted thereby.

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.

As of December 31, 2023, $ 80.0 million in capacity remains under the May 2022 ATM.

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.

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 .

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.

The net proceeds from the December 2020 ATM were $ 39.6 million after deducting underwriter commissions of $ 1.2 million.

For the year ended December 31, 2021, the Company raised gross proceeds of $ 0.8 million pursuant to the December 2020 ATM through the sale of 73,221 shares of common stock at a weighted average price of $ 10.27 per share.

The net proceeds from the December 2020 ATM were $ 0.7 million after deducting underwriter commissions of $ 22,555 .

Equity Offerings

Private Placement of up to $ 240 million

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.

The Pre-Funded Warrants are exercisable immediately for $ 0.0001 per share and until exercised in full.

• The first tranche, which closed on January 8, 2024, resulted in the purchase by the Investors of an aggregate of $ 80 million of Common Stock (or Pre-Funded Warrants) from the Company at a price of $ 1.43 per share;

• The second tranche is a conditional mandatory purchase by the Investors of an additional $ 80 million of Common Stock (or Pre-Funded Warrants) from the Company at a price of $ 1.716 per share, equal to 120 % of the price paid in the first tranche and is subject to the satisfaction of three conditions:

◦ release by the Company of topline data from its Phase 2b clinical trial of vidofludimus calcium (IMU-838) in progressive multiple sclerosis, which data is currently expected in or around April 2025;

◦ the 10-day volume-weighted average price of the Common Stock is at least $ 8.00 per share during the 6 months following the data release;

◦ aggregate trading volume during the same 10-day period is at least $ 100 million.

• 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.

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.

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).

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.

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.

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.

Therefore, total gross proceeds from the offering to the Company could actually be between $ 80 million and $ 240 million.

Gross proceeds to the Company will be reduced by fees paid to the placement agents, capital markets advisors and payments of transaction expenses.

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

$ 60 million Private Placement Equity Financing

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The registration statement for these securities was deemed effective by Securities and Exchange Commission on December 20, 2022.

July 2021 Public Equity Offering

On July 15, 2021, the Company entered into an underwriting agreement with Piper Sandler & Co., in connection with the Company’s public offering of 4,500,000 shares of the Company’s common stock, $ 0.0001 par value per share, at a public offering price of $ 10.00 per share.

On July 19, 2021, the Company closed the Offering.

The net proceeds to the Company from the Offering was approximately $ 42.0 million, after deducting underwriting discounts and commissions and estimated offering expenses payable by the Company.

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 .

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Through December 31, 2023, no cash dividends had been declared or paid.

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 ;

the Special Meeting date is set for March 4, 2024 with a record date of January 19, 2024.

Preferred Stock

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2021 Employee stock purchase plan 11

Prefunded stock warrants 5,096,552

Outstanding stock options 6,196,140

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2017 Inducement Equity Incentive Plan 46,250

2019 Omnibus Equity Incentive Plan 188,655

2019 Omnibus Equity Incentive Plan, as amended on June 28, 2023 4,153,689

Total common shares reserved for future issuance 10,439,401

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The maximum number of shares reserved for delivery under the plan is 200,000 shares.

The Company has issued 70,351 and 12,758 shares under the ESPP for the twelve months ended December 31, 2022 and 2021, respectively.

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.

The first enrollment period under the plan commenced on August 1, 2021 and the Company has issued 199,989 shares life-to-date under the ESPP.

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.

Stock Option Programs

In July 2019, the Company’s stockholders approved the 2019 Omnibus Equity Incentive Plan (the “2019 Plan”) which was adopted by the Board with an effective date of June 14, 2019.

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.

The 2019 Plan allows for the grant of equity awards to employees, consultants and non-employee directors.

An initial maximum of 1,500,000 shares of the Company’s common stock were available for grant under the 2019 Plan.

The 2019 Plan includes an evergreen provision that allows for the annual addition of up to 4 % of the Company’s fully-diluted outstanding stock, with a maximum allowable increase of 4,900,000 shares over the term of the 2019 Plan.

The 2019 Plan included an evergreen provision that allowed for the annual addition of up to 4 % of the Company’s fully-diluted outstanding stock, with a maximum allowable increase of 4,900,000 shares over the term of the 2019 Plan.

In accordance with this provision, the shares available for grant were increased in 2020 through 2023 by a total of 4,408,871 shares.

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 restrictions of awards under the 2019 Plan at its discretion.

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.

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

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 .

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All awards granted under these plans have either been forfeited or expired.

There remain 43,311 shares available for grant under the 2014 Plan as of December 31, 2022.

In September 2017, Vital’s Board of Directors approved the Inducement Plan, which was amended and restated in November 2017.

There remains 43,311 shares available for grant under the 2014 Plan as of December 31, 2023.

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.

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Deferred tax liabilities:

Property, plant and equipment — ( 2 )

Total deferred tax liability — —

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As a result, the Company has maintained a full valuation allowance against the entire balance of its net deferred tax assets since the date of inception.

The valuation allowance has increased by $ 14.2 million and $ 22.3 million and for the years ended December 31, 2021 and 20, respectively.

As of December 31, 2022, Immunic had available NOLs of approximately $ 190.2 million in Germany and Australia.

The valuation allowance has increased by $ 26.0 million and $ 14.2 million for the years ended December 31, 2023 and 2022, respectively.

As of December 31, 2023, Immunic had available NOLs of approximately $ 284.5 million in Germany and $ 5.9 million in Australia, respectively.

These NOLs do not expire.

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There were no such interest or penalties for any of the years presented.

Changes in Board of Directors

Appointment of Richard Rudick, M.D.

to Board of Directors

On April 27, 2023, the Company announced the appointment of Dr.

Richard Rudick as a member of the Board of Directors, effective as of April 26, 2023.

As a Class III director, Dr.

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.

Director Resignation

Vincent Ossipow retired from the Board of Directors on June 28, 2023.

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.

Related Party Transactions

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Nash entered into the Executive Chairman Agreement.

The Executive Chairman Agreement establishes an “at will” employment relationship with a base salary of $ 25,417 per month pursuant to which Dr.

Nash serves as Executive Chairman and contemplated a term that ends on October 15, 2020.

On October 15, 2020, the Company and Dr.

Nash entered into an addendum (the “First Addendum”) to extend the term of the Executive Chairman Agreement to April 15, 2021.

In connection with the First Addendum, the Company made a one-time award to Dr.

Nash of an option to purchase 120,000 shares of Company common stock, which vests monthly over six months commencing on November 15, 2020.

On April 15, 2021, the Company and Dr.

Nash entered into Addendum No.

Two (the “Second Addendum”) to extend the term of the Executive Chairman Agreement to April 15, 2022.

In connection with the Second Addendum, the Company made a one-time award to Dr.

Nash of an option to purchase 90,000 shares of Company common stock, which vests monthly over 12 months commencing on May 15, 2021, and to increase Dr.

Nash’s monthly base salary to $ 27,960 from $ 25,417 .

On March 15, 2022, the Company and Dr.

Nash entered into Addendum No.

Three (the “Third Addendum”), which extended the term of employment from April 15, 2022 to December 31, 2022 with a base salary of $ 29,358 per month.

In connection with the Third Addendum, the Company made a one-time award to Dr.

Nash of an option to purchase 75,000 shares of the Company’s common stock, which vests monthly over 12 months commencing on April 10, 2022.

The Executive Chairman Agreement establishes an “at will” employment relationship.

On December 28, 2022, the Company and Dr.

Nash entered into Addendum No.

Four, which extended the term of employment from December 31, 2022 to December 31, 2023 with a base salary of $ 30,250 per month (which includes the cash retainer payable for serving on the Company’s Board or for acting as the Chairman of the Board).

Four, which extended the term of employment from December 31, 2022 to December 31, 2023 with a base salary of $ 30,250 per month.

On October 17, 2023, Immunic, Inc.

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.

Nash’s employment as Executive Chairman of the Board of Directors of the Company to December 31, 2024.

In connection with the Addendum, 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).

All other terms of the Executive Chairman Agreement remain the same.

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Joerg Neermann

/s/ VINCENT OSSIPOW Director February 23, 2023

Vincent Ossipow

/s/ RICHARD RUDICK Director February 22, 2024

Richard Rudick

/s/ BARCLAY A.

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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.

What changed 10-K

Item 9A. Controls and Procedures