Form 8-K - Current report

UNITED STATES
SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 8-K

CURRENT REPORT
Pursuant to Section 13 or 15(d) of The Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): July 21, 2024

IMMUNIC, INC.

(Exact name of registrant as specified in its charter)

Delaware	001-36201	56-2358443
(State or other jurisdiction of incorporation)	(Commission File Number)	(IRS Employer Identification No.)

1200 Avenue of the Americas, Suite 200

New York, NY 10036

USA

(Address of principal executive offices)

Registrant’s telephone number, including area code: (332) 255-9818

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

☐	Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
☐	Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
☐	Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
☐	Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

Title of each class	Trading Symbol(s)	Name of exchange on which registered
Common Stock, par value $0.0001	IMUX	The Nasdaq Stock Market LLC

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b2 of this chapter).

Emerging growth company ☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. Yes ☐ No ☐

Item 5.02. Departure of Directors or Principal Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers.

On July 24, 2024, Immunic, Inc. (the “Company”) announced the appointment of Simona Skerjanec, M.Pharm, MBA, as a member of the board of directors (the “Board”) of the Company, effective as of July 22, 2024. As a Class I director, Ms. Skerjanec’s term lasts until the Company’s 2027 annual meeting of stockholders (the “Annual Meeting”).

Ms. Skerjanec, age 60, has nearly thirty years of global experience in the pharmaceutical industry overseeing product commercialization and business strategy initiatives. From March 2015 until December 2023, Ms. Skerjanec held several leadership positions at Roche in Switzerland, where she most recently served as Senior Vice President, Global Head of Neuroscience and Rare Diseases. In this role, Ms. Skerjanec led business and global corporate strategy for Roche’s portfolio of neurological and rare diseases. Previously, Ms. Skerjanec served as General Manager of Roche in Portugal and served as the Neuroimmunology Franchise Head where she was in charge of certain drug commercialization efforts on behalf of the company. Prior to joining Roche, Ms. Skerjanec was Senior Vice President and Cardiovascular Franchise Head at The Medicines Company where she held various roles in development and commercialization from July 2003 to February 2015. Before her employment at The Medicines Company, Ms. Skerjanec held positions at Eli Lilly, Pfizer, and Johnson & Johnson. Since May 2024, Ms. Skerjanec has served on the board of directors of Avidity Biosciences. Ms. Skerjanec received her M.Pharm from the University of Ljubljana School of Pharmacy and her MBA from Fairleigh Dickinson University. The Nominating and Corporate Governance Committee and the Board believe that Ms. Skerjanec’s expertise and decades-long management of research and development and product commercialization efforts in the therapeutic areas of rare diseases, cardiology and neurology provide valuable skills to the Board.

In connection with her appointment as a director, Ms. Skerjanec received an inducement grant of options to purchase up to a total of 100,000 shares of the Company’s common stock, which vest on a monthly basis over a period of three years, effective July 22, 2024. In addition, effective July 22, 2024, Ms. Skerjanec received a grant of options to purchase up to a total of 50,000 shares of the Company’s common stock, which vest on a monthly basis during a period of one year. The foregoing options have an exercise price per share of $1.46, the closing price of the Company’s common stock on The Nasdaq Stock Market on July 22, 2024. Ms. Skerjanec will also receive cash compensation for her service on the Board in accordance with the Company’s non-employee director compensation policy, as described in the Company’s most recent proxy statement.

Ms. Skerjanec and the Company entered into the Company’s standard form of indemnification agreement for directors and executive officers, the form of which has been incorporated by reference in the Company’s most recent annual report on Form 10-K.

Ms. Skerjanec is not a party to, and does not have any direct or indirect material interest in, any transaction requiring disclosure under Item 404(a) of Regulation S-K. There are no arrangements or understandings between Ms. Skerjanec and any other persons pursuant to which she was selected as a director of the Company.

Effective on July 21, 2024, the Board determined that in connection with Ms. Skerjanec’s appointment to the Board, the size of the Board will be increased from seven to eight directors.

A copy of the press release announcing the appointment of Ms. Skerjanec to the Board is filed with this Form 8-K as Exhibit 99.1.

Item 9.01. Financial Statements and Exhibits.

Exhibit No.	Description of Exhibit

99.1	Press release dated July 24, 2024.

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned, hereunto duly authorized.

Dated: July 24, 2024	Immunic, Inc.

	By:	/s/ Daniel Vitt
		Daniel Vitt
		Chief Executive Officer

Immunic, Inc. Strengthens Its Board of Directors with the Appointment of Experienced Pharmaceutical Executive Simona Skerjanec

– Senior Executive and Thought Leader in Brain Health with Nearly Three Decades of Global Pharmaceutical Experience –

– Served as Neuroimmunology Franchise Head Responsible for Roche’s Blockbuster Launch of Multiple Sclerosis Therapy Ocrevus® –

NEW YORK, July 24, 2024 – Immunic, Inc. (Nasdaq: IMUX), a biotechnology company developing a clinical pipeline of orally administered, small molecule therapies for chronic inflammatory and autoimmune diseases, today announced the appointment of Simona Skerjanec, M.Pharm, MBA, a thought-leader in brain health with decades of experience in drug development and commercialization, to its board of directors, effective July 22, 2024.

Over a nearly three-decade career in the United States and internationally, Ms. Skerjanec has led research and development efforts culminating in numerous regulatory drug approvals and successful commercial launches. Most recently, Ms. Skerjanec served as Senior Vice President, Global Head Neuroscience and Rare Diseases at Roche. In this role, she led business and global corporate strategy for Roche's portfolio of neurological and rare diseases, achieving sustainable double digit growth in sales, including with Ocrevus® (ocrelizumab)*, which remains one of the most successful medicines for the treatment of multiple sclerosis (MS). Earlier at Roche, Ms. Skerjanec served as Neuroimmunology Franchise Head, responsible for the commercial launch of Ocrevus®, generating over $1 billion in sales in the first ten months of commercialization. Prior to joining Roche, Ms. Skerjanec held positions of increasing responsibility in development and commercialization at The Medicines Company, Eli Lilly, Pfizer and Johnson & Johnson. Ms. Skerjanec also serves on the Board of Directors of Avidity Biosciences.

“We are thrilled to add someone of Simona’s exceptional caliber and expertise to our Board of Directors,” stated Duane Nash, M.D., J.D., M.B.A., Chairman of the Board of Directors of Immunic. “As the company approaches multiple late-stage readouts for vidofludimus calcium in MS over the next two years, we are determined to continue building a strong foundation for potential success. Earlier this month, we were delighted to bring on Jason Tardio, a former Novartis and Biogen executive with extensive MS drug commercialization experience, as Immunic’s new Chief Operating Officer and President. Now with Simona’s entry onto the board, we are proud to augment the company’s growing strength with a board member with such exceptional global leadership experience and who previously led one of the most successful commercial launches in MS history. Simona’s guidance will be invaluable.”

“I am very excited to join the Board of Directors of Immunic and look forward to working closely with the executive management team and the other board members,” added Ms. Skerjanec. “MS remains a devastating disease for many patients and their families. In my view, vidofludimus calcium is a particularly valuable oral drug candidate, with a highly differentiated profile and the potential to transform the treatment landscape and bring longer lasting independence to people with MS. I look forward to working with the team, and hope to help bring such an important molecule to market and achieve commercial success.”

* OCREVUS® is a trademark of Genentech, Inc.

About Immunic, Inc.

Immunic, Inc. (Nasdaq: IMUX) is a biotechnology company developing a clinical pipeline of orally administered, small molecule therapies for chronic inflammatory and autoimmune diseases. The company's lead development program, vidofludimus calcium (IMU-838), is currently in phase 3 and phase 2 clinical trials for the treatment of relapsing and progressive multiple sclerosis, respectively, and has shown therapeutic activity in phase 2 clinical trials in patients suffering from relapsing-remitting multiple sclerosis, progressive multiple sclerosis and moderate-to-severe ulcerative colitis. Vidofludimus calcium combines neuroprotective effects, through its mechanism as a first-in-class nuclear receptor related 1 (Nurr1) activator, with additional anti-inflammatory and anti-viral effects, by selectively inhibiting the enzyme dihydroorotate dehydrogenase (DHODH). IMU-856, which targets the protein Sirtuin 6 (SIRT6), is intended to restore intestinal barrier function and regenerate bowel epithelium, which could potentially be applicable in numerous gastrointestinal diseases, such as celiac disease, for which it is currently in preparations for a phase 2 clinical trial. IMU-381, which currently is in preclinical testing, is a next generation molecule being developed to specifically address the needs of gastrointestinal diseases. For further information, please visit: www.imux.com.

Cautionary Statement Regarding Forward-Looking Statements

This press release contains “forward-looking statements” that involve substantial risks and uncertainties for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical facts, included in this press release regarding new management hires and promotions, new directors, strategy, future operations, future financial position, future revenue, projected expenses, sufficiency of cash, expected timing, development and results of clinical trials, prospects, plans and objectives of management are forward-looking statements. Examples of such statements include, but are not limited to, statements relating to Immunic's development programs and the targeted diseases; the potential for Immunic's development programs to safely and effectively target diseases; preclinical and clinical data for Immunic's development programs; the timing of current and future clinical trials and anticipated clinical milestones; the nature, strategy and focus of the company and further updates with respect thereto; the development and commercial potential of any product candidates of the company; expectations regarding the capitalization, resources and ownership structure of the company; new appointments to Immunic’s board of directors; and the executive and board structure of the company. Immunic may not actually achieve the plans, carry out the intentions or meet the expectations or projections disclosed in the forward-looking statements and you should not place undue reliance on these forward-looking statements. Such statements are based on management’s current expectations and involve substantial risks and uncertainties. Actual results and performance could differ materially from those projected in the forward-looking statements as a result of many factors, including, without limitation, increasing inflation, impacts of the Ukraine – Russia conflict and the conflict in the Middle East on planned and ongoing clinical trials, risks and uncertainties associated with the ability to project future cash utilization and reserves needed for contingent future liabilities and business operations, the availability of sufficient financial and other resources to meet business objectives and operational requirements, the fact that the results of earlier preclinical studies and clinical trials may not be predictive of future clinical trial results, the protection and market exclusivity provided by Immunic’s intellectual property, risks related to the drug development and the regulatory approval process and the impact of competitive products and technological changes. A further list and descriptions of these risks, uncertainties and other factors can be found in the section captioned “Risk Factors,” in the company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2023, filed with the SEC on February 22, 2024, and in the company’s subsequent filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov or ir.imux.com/sec-filings. Any forward-looking statement made in this release speaks only as of the date of this release. Immunic disclaims any intent or obligation to update these forward-looking statements to reflect events or circumstances that exist after the date on which they were made. Immunic expressly disclaims all liability in respect to actions taken or not taken based on any or all the contents of this press release.

Contact Information

Immunic, Inc.
Jessica Breu
Vice President Investor Relations and Communications
+49 89 2080 477 09
jessica.breu@imux.com

US IR Contact
Rx Communications Group
Paula Schwartz
+1 917 633 7790
immunic@rxir.com

US Media Contact
KOGS Communication
Edna Kaplan
+1 617 974 8659
kaplan@kogspr.com

Cover	Jul. 21, 2024
Cover [Abstract]
Document Type	8-K
Amendment Flag	false
Document Period End Date	Jul. 21, 2024
Entity File Number	001-36201
Entity Registrant Name	IMMUNIC, INC
Entity Central Index Key	0001280776
Entity Tax Identification Number	56-2358443
Entity Incorporation, State or Country Code	DE
Entity Address, Address Line One	1200 Avenue of the Americas
Entity Address, Address Line Two	Suite 200
Entity Address, City or Town	New York
Entity Address, State or Province	NY
Entity Address, Country	US
Entity Address, Postal Zip Code	10036
City Area Code	(332)
Local Phone Number	255-9818
Written Communications	false
Soliciting Material	false
Pre-commencement Tender Offer	false
Pre-commencement Issuer Tender Offer	false
Title of 12(b) Security	Common Stock, par value $0.0001
Trading Symbol	IMUX
Security Exchange Name	NASDAQ
Entity Emerging Growth Company	false