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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):
March 27, 2026
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 March 31, 2026, Immunic, Inc., a Delaware corporation
(the “Company”), announced the appointment of Jon Congleton as a member of the board of directors (the “Board”)
of the Company, effective as of March 27, 2026. As a Class II director, Mr. Congleton’s term lasts until the Company’s 2028
annual meeting of stockholders (the “Annual Meeting”). Mr. Congleton will also act as Chair of the Compensation Committee
of the Board.
Mr. Congleton, age 62, has served as President
and Chief Executive Officer and as a member of the board of directors of Mineralys Therapeutics, Inc. (“Mineralys”) since
November 2020. Prior to joining Mineralys, Mr. Congleton was the Chief Executive Officer of Impel NeuroPharma, Inc. from September 2017
to May 2020. Prior to that, he served as the Chief Executive Officer and as a director of Nivalis Therapeutics, Inc. from January 2015
to February 2017. Mr. Congleton was previously at Teva Pharmaceutical Industries Ltd. (Teva), where for over 18 years, he held positions
in general management and global strategic marketing, including Senior Vice President of Teva’s Global Central Nervous System Disorders
from April 2013 to December 2014, Senior Vice President of the Global Medicine Group from November 2011 to April 2013, and General Manager
of Teva Neuroscience, Inc. in the United States. Prior to joining Teva, Mr. Congleton spent ten years in a variety of commercial roles
with predecessor companies of Sanofi. Mr. Congleton earned a B.S. in marketing from Kansas State University.
In connection with his appointment as a director,
Mr. Congleton received an inaugural grant of options to purchase up to a total of 500,000 shares of the Company’s common stock,
effective March 27, 2026, which vest on a monthly basis over a three year period. The foregoing options have an exercise price per
share equal to the closing price of the Company’s common stock on The Nasdaq Stock Market on March 27, 2026 (the “Award”).
The Award is subject to the approval by the Company’s shareholders of an increase to the number of shares reserved for issuance
under the Company’s 2019 Omnibus Equity Incentive Plan. Mr. Congleton will also receive cash compensation for his 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, as may be adjusted from time to time as set forth in the Company’s filings and reports made with the Securities
and Exchange Commission.
Mr. Congleton 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.
Mr. Congleton 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 Mr. Congleton and any other persons pursuant to which he was selected as a director of the Company.
Effective on March 27, 2026, the Board determined
that in connection with Mr. Congleton’s appointment to the Board, the size of the Board will be increased from eight to nine directors.
Item 7.01 Regulation FD Disclosure.
On March 31, 2026, the Company issued a press
release, a copy of which is filed herewith as Exhibit 99.1, announcing the appointment of Mr. Congleton. The information set forth in
this Item 7.01 and in Exhibit 99.1 is furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities
Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that Section. The information
in this Item 7.01 and in Exhibit 99.1 shall not be deemed to be incorporated by reference into any filing of the Company under the Securities
Act, or the Exchange Act, whether made before or after the date hereof, except as shall be expressly set forth by specific reference in
such a filing.
Item 9.01. Financial Statements and Exhibits.
| Exhibit No. |
Description of Exhibit |
| 99.1 |
Press release, dated March 31, 2026 |
| 104 |
Cover Page to this Current Report on Form 8-K in Inline XBRL |
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: March 31, 2026 |
Immunic, Inc. |
| |
|
|
| |
By: |
/s/ Daniel Vitt |
| |
|
Daniel Vitt |
| |
|
Chief Executive Officer |
Immunic Strengthens Its Board
of Directors with the Appointment of Seasoned Biopharmaceutical Executive Jon Congleton
–
Nearly 40-Year Biopharmaceutical Professional with Deep CNS and Commercial Leadership Experience in Multiple Sclerosis –
–
Served on Original Team Responsible for the Launch of Copaxone® in the United States –
NEW YORK,
March 31, 2026 – Immunic, Inc. (Nasdaq: IMUX), a late-stage biotechnology
company pioneering the development of novel oral therapies for neurologic diseases, today announced the appointment of Jon Congleton,
a seasoned biopharmaceutical executive with nearly 40 years of experience spanning drug development, commercialization and corporate leadership,
to its Board of Directors, effective March 27, 2026.
Mr. Congleton has a strong track record of building
and leading biopharmaceutical organizations and advancing innovative therapies. During his career, he has worked across cardiovascular,
gastrointestinal, and central nervous system (CNS) organizations, with a focus on delivering solutions for patients and their caregivers.
He played a key role in the U.S. launch of Teva Pharmaceuticals Industries Ltd.’s Copaxone®, a subcutaneous injection treatment
for relapsing forms of multiple sclerosis (MS), and led the U.S. operations when it became the number one prescribed MS treatment.
Mr. Congleton currently serves as Chief Executive
Officer (CEO) and member of the Board of Directors of Mineralys Therapeutics, Inc., focused on aldosterone-driven cardiorenal conditions.
As CEO, he guided the company from an early-stage private entity to the publicly traded, pre-commercial biotechnology firm it
is today. Previously, he served as CEO and Board member of both CNS company Impel NeuroPharma, Inc. and cystic fibrosis company Nivalis
Therapeutics, Inc.. Earlier, Mr. Congleton held several senior leadership roles at Teva Pharmaceuticals, eventually leading its United
States and Canadian neuroscience businesses and global CNS franchise.
“MS remains a devastating disease for the
patients and their families. Jon’s deep CNS expertise and proven track record in late-stage drug development and commercialization
will be invaluable as we advance vidofludimus calcium through its pivotal clinical milestones and toward potential regulatory approval
and commercial launch,” stated Simona Skerjanec, M.Pharm, MBA, Interim Chairperson of the Board of Directors of Immunic. “I
am thrilled that Jon is joining us at this critical moment as we evolve our Board to support Immunic in its transition into a fully integrated
commercial-stage company.”
“I am excited to join Immunic’s Board
at such a pivotal moment for the company’s MS program,” added Mr. Congleton. “Vidofludimus calcium represents a potentially
transformative opportunity for MS patients, offering advantages over currently available therapies, particularly with its unique combination
of neuroprotective, anti-inflammatory and anti-viral effects as well as its favorable safety and tolerability profile shown to date. I
look forward to working with the Board and the leadership team and contributing my experience to support Immunic as it advances toward
the pivotal trial readouts later this year and long-term value creation.”
About Immunic,
Inc.
Immunic, Inc. (Nasdaq:
IMUX) is a late-stage biotechnology company pioneering the development of novel oral therapies for neurologic diseases. The company’s
lead development program, vidofludimus calcium (IMU-838), is currently in phase 3 clinical trials for the treatment of relapsing multiple
sclerosis, for which top-line data is expected to be available by the end of 2026. It has already shown therapeutic activity in phase
2 clinical trials in relapsing-remitting multiple sclerosis, progressive multiple sclerosis and other diseases. 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). The company’s development pipeline
also includes earlier-stage programs, including IMU-856 and IMU-381, aimed at building a broader therapeutics platform addressing neurodegenerative,
chronic inflammatory, and autoimmune-related 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 strategy, future
operations, future financial position, future revenue, projected expenses, sufficiency of cash and cash runway, 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, anticipated clinical milestones and regulatory approvals; 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, tariffs and macroeconomics trends, 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, and the ability to raise sufficient capital to continue as a
going concern, the fact that the results of earlier preclinical studies and clinical trials may not be predictive of future clinical trial
results, any changes to the size of the target markets for the company’s products or product candidates, 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, 2025, filed with the SEC on February 26, 2026, and in the company’s subsequent filings with the SEC. 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 of 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
KCSA Strategic Communications
Caitlin Kasunich
+1 212 896 1241
ckasunich@kcsa.com