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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): February
12, 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
1.01. Entry into a Material Definitive Agreement.
Private Placement
Securities Purchase Agreement
On February 12, 2026, Immunic Inc. (the “Company”)
entered into a securities purchase agreement (the “Securities Purchase Agreement”) with certain accredited investors
(the “Investors”), pursuant to which the Company agreed to issue and sell, in a private placement (the “Offering”),
pre-funded warrants (the “Pre-Funded Warrants”, and the shares of Common Stock (as defined below) issuable upon exercise
of the Pre-Funded Warrants, the “Pre-Funded Warrant Shares”) to purchase up to 0.0001 shares of the Company’s common
stock, par value $0.0001 per share (“Common Stock”), with each Pre-Funded Warrant accompanied by a warrant to purchase
(i) a share of Common Stock or (ii) a pre-funded warrant to purchase a share of Common Stock (collectively, the “Common Warrants”
and together with the Pre-Funded Warrants, the “Warrants”, and the shares of Common Stock issuable upon exercise of
the Common Warrants, the “Common Warrant Shares”, and together with the Pre-Funded Warrant Shares, the “Warrant
Shares”).
The purchase price for each Pre-Funded Warrant and accompanying Common
Warrant is $0.873120. Each Pre-Funded Warrant is immediately exercisable at a price of $0.0001 per share. Each Common Warrant is exercisable
at a price $0.873220 per share (subject to adjustment as set forth therein) following the completion of the Reverse Stock Split (as defined
below) until the earlier of (i) 30 trading days following the date of the Company’s initial public announcement of topline data
from its Phase 3 ENSURE trials (for the avoidance of doubt, the later date of the initial public announcement of topline data from ENSURE-1
or ENSURE-2, if announced separately) (the “Topline Data Announcement”), (ii) immediately upon the exercise of the
Pre-Funded Warrants if such exercise of Pre-Funded Warrants is prior to the Topline Data Announcement, provided that if the Pre-Funded
Warrant is not exercised in full, the Common Warrant expires proportionally only to the extent the Pre-Funded Warrant is exercised, and
(iii) February 17, 2031.
The aggregate gross proceeds to the Company from the issuance and sale
of the Warrants is expected to be approximately $200 million, before deducting fees to be paid to the placement agents and financial
advisors of the Company and other estimated offering expenses payable by the Company. The aggregate exercise price of the Warrants is
approximately $200 million.
Leerink Partners LLC, Stifel, Guggenheim Securities, William Blair,
LifeSci Capital, B. Riley Securities and Brookline Capital Markets, a division of Arcadia Securities, LLC acted as placement agents for
the Offering. As compensation in connection with the Offering, the Company has agreed to pay the placement agents a fee equal to 6% of
the aggregate gross proceeds received by the Company (i) upon the issuance of the Warrants at closing and (ii) upon the cash exercise
of the Common Warrants.
The Offering
The closing of the Offering is expected to occur on or about February
17, 2026 (the “Closing Date”). The Company intends to use the net proceeds from the Offering to fund its clinical
trials and operations and for working capital and other general corporate purposes.
The securities issued in the Offering have not been registered under
the Securities Act of 1933, as amended (the “Securities Act”), and until so registered the securities may not be offered
or sold absent registration or availability of an applicable exemption from registration. There is no established public trading market
for the Warrants, and the Company does not intend to list such securities on any national securities exchange or nationally recognized
trading system.
In connection with the Offering, the Company and each Investor entered
into a registration rights agreement simultaneously with the Securities Purchase Agreement (the “Registration Rights Agreement”).
Pursuant to the Registration Rights Agreement, as promptly as reasonably practicable following the Closing Date but, in any event, not
later than 45 days thereafter (the “Filing Date”) the Company shall file a resale registration statement on Form S-3
(or Form S-1 if Form S-3 is not available) providing for the resale by the Investors of the Registrable Securities (as defined in the
Registration Rights Agreement) and to use reasonable best efforts to cause such resale registration statement to be declared effective
by the staff of the Securities and Exchange Commission (the “Commission”) at the earliest possible date but no later
than the earlier of (a) the 60th calendar day following the Filing Date if the SEC notifies the Company that it will review the registration
statement and (b) the fifth business day after the Company is notified by the SEC that the registration statement will not be “reviewed”
or will not be subject to further review or (ii) the fifth business day following the receipt of Stockholder Approval and the consummation
of the Reverse Stock Split.
The Securities Purchase Agreement and Registration Rights Agreement
contain certain representations and warranties, covenants and indemnities customary for similar transactions. The representations, warranties
and covenants contained in the Securities Purchase Agreement and Registration Rights Agreement were made solely for the benefit of the
parties to the Securities Purchase Agreement and Registration Rights Agreement, respectively, and may be subject to limitations agreed
upon by the contracting parties.
Special Meeting and Reverse Stock Split
The Securities Purchase Agreement provides that no later than three
days following the Closing Date, the Company will file a preliminary proxy statement with the Commission for the purpose of receiving
stockholder approval (“Stockholder Approval”) of an amendment to the Company’s certificate of incorporation to
effect a reverse stock split of the Company’s issued and outstanding Common Stock, at a ratio of not less than 10:1 (the “Reverse
Stock Split”). The Company will then file a definitive proxy statement within three days of being permitted to do so in accordance
with the Securities Exchange Act of 1934, as amended.
The form of Pre-Funded Warrant, form of Common Warrant, Securities
Purchase Agreement, and Registration Rights Agreement, are filed as Exhibits 4.1, 4.2, 10.1, and 10.2, respectively, to this Current Report
on Form 8-K. The foregoing summaries of the terms of the Warrants, Warrant Shares, and Common Stock, and the terms of the Securities Purchase
Agreement, and Registration Rights Agreement are subject to, and qualified in their entirety by, the full text of such documents, where
applicable, which are incorporated herein by reference.
No statement in this report or the attached exhibits is an offer to
sell or a solicitation of an offer to purchase the Company’s securities, and no offer, solicitation or sale will be made in any
jurisdiction in which such offer, solicitation or sale is unlawful.
Royalty Purchase Agreement
As previously disclosed, on June 3, 2025, the Company issued series
B common stock warrants to purchase up to an aggregate of 86,666,667 shares of Common Stock (or prefunded warrants to purchase shares
of Common Stock) in an underwritten public offering (the “Series B Warrants”). On February 12, 2026, the Company entered
into a purchase and sale agreement (the “Royalty Purchase Agreement”) with certain Series B Warrant holders who had
purchased a predetermined number of Series B Warrants (each a “Participating Series B Holder”) and BVF Partners, L.P.
(“BVF”), acting as royalty interest agent (the “Warrant Exchange”). Pursuant to the Royalty Purchase
Agreement, the Participating Series B Holders will exchange an aggregate of 51,087,000 Series B Warrants for a pro rata share of an aggregate
5% synthetic royalty on future sales of the Company’s vidofludimus calcium program in any country (the “Royalty Interests”).
The pro rata share for each Participating Series B Holder is equal to the number of Series B Warrants exchanged by such Participating
Series B Holder divided by the number of Series B Warrants exchanged by all Participating Series B Holders (expressed as a percentage).
Royalty Interests will be due and payable quarterly by the Company to the Participating Series B Holders following the First Commercial
Sale (as defined in the Royalty Purchase Agreement).
Pursuant to the Royalty Purchase Agreement, the Company has agreed
to specified affirmative and negative covenants, including without limitation covenants regarding periodic reporting of information by
the Company to the Participating Series B Holders, and audits of royalties paid under the Royalty Purchase Agreement. The Royalty Purchase
Agreement also contains representations and warranties, other covenants, indemnification obligations, and other provisions customary for
transactions of this nature.
The Company anticipates that on the Closing Date, Series B Warrants
to purchase up to an aggregate of 51,087,000 shares of Common Stock will be surrendered by Participating Series B Holders and cancelled,
and Series B Warrants to purchase up to an aggregate of 35,579,667 shares of Common Stock remain issued and outstanding.
The form of Royalty Purchase Agreement is filed as Exhibit 10.3 to
this Current Report on Form 8-K. The foregoing summary of the terms of the Royalty Purchase Agreement is subject to, and qualified in
its entirety by, the full text of such document, where applicable, which is incorporated herein by reference.
Item 3.02 Unregistered Sales of Equity Securities.
The information contained above in Item 1.01 under the sub-heading
“Private Placement” and below in Item 8.01 below are hereby incorporated by reference into this Item 3.02. The Warrants are
being sold and, upon exercise the securities underlying the Warrants, will be issued without registration under the Securities Act, in
reliance on the exemptions provided by Section 4(a)(2) of the Securities Act as a transaction not involving a public offering and Rule
506 promulgated under the Securities Act as sales to accredited investors, and in reliance on similar exemptions under applicable state
laws.
Item 5.02. Departure of Directors or Principal
Officers; Election of Directors; Appointment of Principal Officers.
Appointment of Director
On February 12, 2026, the board of directors of the Company (the “Board”),
following the recommendation of the Nominating and Corporate Governance Committee of the Board (the “Committee”), appointed
Thor Nagel to the Board until the 2026 annual meeting of stockholders as a Class III director or until his respective successors are duly elected and qualified.
Thorvald “Thor” Nagel has served as an Analyst at BVF,
since July 2023, where he conducts in-depth equity research and contributes to investment analysis across the life sciences sector. From
June 2021 through July 2023, Mr. Nagel was a senior analyst with at Monashee Investment Management LLC. He previously held roles with
Stifel Financial Corp. Mr. Nagel received his Master of Science from the University of Notre Dame and his Bachelor’s degree in
Chemical Engineering from Vanderbilt University.
Other than BVF’s relationship with Mr. Nagel, there is no relationship
or agreement between Mr. Nagel and any other person pursuant to which he was selected as a director of the Company and there is no family
relationship between Mr. Nagel and any of the Company’s directors or executive officers. The Company is not aware of any transaction
involving Mr. Nagel which would require disclosure under Item 404(a) of Regulation S-K promulgated under the Securities Act, other than
as set forth in this Current Report on Form 8-K. The Company will enter into a customary indemnity agreement with Mr. Nagel, consistent
with the form filed as Exhibit 10.7 of the Company’s Annual Report on Form 10-K for the year ended December 31, 2024, filed with
the Commission on March 31, 2025.
Appointment of Chair
On February 12, 2026, the Board, following the recommendation of
the Committee, appointed Simona Skerjanec to serve as Interim Chairperson of the Board. Ms. Skerjanec has been a member of the Board since
July 2024, and information regarding Ms. Skerjanec’s background and qualifications can be found in the Company’s definitive
proxy statement filed with the Commission on April 22, 2025 in connection with the Company’s 2025 annual meeting of stockholders.
Resignation of Director
On February 12, 2026, Maria Törnsén
resigned as a member of the Board in connection with the Offering. The resignation of Ms. Törnsén was not the result of any
disagreement with the Company on any matter relating to the Company’s operations, policies, or practices. The Board and the Company
are deeply grateful for Ms. Törnsén’s service, dedication, and contributions to the Company.
Item 8.01 Other Events.
On February 13, 2026, the Company issued a press
release announcing, among other things, the commencement of the Offering, a copy of which is attached hereto as Exhibit 99.1 and incorporated
by reference herein.
Forward Looking Statements
This Current Report on Form 8-K contains forward-looking statements
within the meaning of The Private Securities Litigation Reform Act of 1995, including without limitation statements regarding the Company’s
intended use of the net proceeds from the Offering, the filing and timing of a resale registration statement. Actual results might differ
materially from those explicit or implicit in the forward-looking statements. Important factors that could cause actual results to differ
materially include: risks associated with market conditions; risks associated with the Company’s cash needs; and risks and uncertainties
associated with the Company’s business and finances in general; and other risks and uncertainties set forth from time to time in
the Company’s filings with the Commission. Any forward-looking statements contained in this Current Report on Form 8-K speak only
as of the date hereof, and the Company expressly disclaims any obligation to update any forward-looking statements, whether because of
new information, future events or otherwise.
Item 9.01. Financial Statements and Exhibits
| Exhibit |
Description |
| |
|
| 4.1 |
Form of Pre-Funded Warrant |
| 4.2 |
Form of Common Warrant |
| 10.1 |
Form of Securities Purchase Agreement, dated February 12, 2026 by and among Immunic, Inc. and the purchasers named therein. |
| 10.2 |
Form of Registration Rights Agreement, dated February 12, 2026 by and among Immunic, Inc. and the holders named therein. |
| 10.3 |
Form of Purchase and Sale Agreement, dated February 12, 2026 by and among Immunic, Inc., the holders named therein, and BVF Partners, L.P. |
| 99.1 |
Press Release dated February 12, 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,
as amended, the Registrant has duly caused this report to be signed on its behalf by the undersigned, hereunto duly authorized.
| Dated: February 13, 2026 |
Immunic, Inc. |
| |
|
|
| |
By: |
/s/ Daniel Vitt |
| |
|
Daniel Vitt |
| |
|
Chief Executive Officer |
Immunic Announces Oversubscribed Private Placement
of up to USD 400 Million to Accelerate Transformation into Commercial-Stage Company
–
Upfront Proceeds of USD 200 Million, with Potential for up to USD 200 Million in Additional Proceeds –
–
Expected to Fund Completion of Phase 3 ENSURE Trials in Relapsing Multiple Sclerosis, Initiation of Phase 3 Trial in Primary Progressive
Multiple Sclerosis, and Transition Into a Commercial Organization –
–
Simona Skerjanec, Former SVP, Global Head of Neuroscience and Rare Diseases at Roche, Elevated to Interim Chairperson of the Board of
Directors –
–
Thor Nagel, Principal at BVF Partners L.P., Joins Board of Directors –
–
Simona Skerjanec and Dr. Daniel Vitt to Lead Search for CEO with Commercial Background –
NEW
YORK, February 13, 2026 – Immunic, Inc.
(Nasdaq: IMUX), a late-stage biotechnology
company pioneering the development of novel oral therapies for neurologic and gastrointestinal diseases, today announced the pricing
of a private placement with gross proceeds of up to USD 400 million priced at the market under Nasdaq rules. The financing was led by
existing investor BVF Partners L.P. and included participation from Aberdeen Investments, Avidity Partners, Coastlands Capital, EcoR1
Capital, Janus Henderson Investors, OrbiMed, RA Capital Management, TCGX, Trails Edge Capital Partners, Vivo Capital, Woodline Partners
LP, and other institutional investors.
Transformation Into
Commercial-Stage Company
The proceeds of this
financing are expected to support Immunic’s strategic transition from a research and development (R&D)-focused company into
a fully integrated commercial entity. In the coming months, the company will prioritize:
| · | Completion of the ongoing phase 3 ENSURE clinical trials of vidofludimus calcium in relapsing multiple
sclerosis (RMS): Top-line data continues to be expected by the end of 2026. Subsequently, Immunic plans to submit a New Drug Application
(NDA) in the United States in mid-2027, with a targeted potential regulatory approval date in 2028. In parallel, Immunic will work on
the preparations for the potential commercialization of vidofludimus calcium, including the pre-commercial ramp-up and expansion of the
medical and commercial teams. |
| · | Initiation of a phase 3 clinical program in primary progressive multiple sclerosis (PPMS): Immunic
is working towards initiation of a phase 3 clinical program, which is expected later this year and estimated to take approximately 3.5
to 4 years to complete. |
With these pivotal programs
underway, Immunic is positioning itself to become a leading innovator in next-generation
oral therapies for relapsing and progressive forms of multiple sclerosis (MS). Vidofludimus calcium is uniquely designed to provide direct
neuroprotective effects by enhancing neuronal survival and function through nuclear receptor-related 1 (Nurr1) activation, while reducing
new inflammatory damage via selective dihydroorotate dehydrogenase (DHODH) inhibition. This first-in-class mechanism has the potential
to address the two key biological drivers of disability progression—relapse-associated worsening (RAW) and progression independent
of relapse activity (PIRA)—potentially offering advantages over currently available therapies that primarily focus on inflammatory
relapses.
Changes in Company
Leadership
Immunic’s Co-Founder
and Chief Executive Officer, Dr. Daniel Vitt, and the Board of Directors will begin a search for a new CEO with deep commercial expertise
in the MS space to lead Immunic through its next stage of growth and into commercialization. Subsequently, Dr. Vitt plans to transition
to a new senior executive role focused on strengthening the company’s scientific strategy and driving portfolio advancement. He
will continue to support the organization in this capacity and as a member of the Board of Directors.
Concurrent with the transaction,
Simona Skerjanec, former SVP, Global Head of Neuroscience and Rare Diseases at Roche, who joined Immunic’s Board of Directors in
July 2024, has been elevated to Interim Chairperson of the Board of Directors. Dr. Duane Nash, former Chairman, will remain a member of
the Board of Directors. Additionally, Thor Nagel, Principal at BVF Partners L.P., has been appointed as a member of the Board of Directors.
The Board of Directors intends to explore and evaluate further refreshment in order to better align its future composition with Immunic’s
strategic goals and objectives. As part of this refreshment, the Board expects that two new directors will replace existing directors
at or prior to Immunic’s upcoming annual meeting with a third director expected to be replaced at or prior to Immunic’s 2027
annual meeting.
“I could not be
prouder of the Immunic team and what we have achieved with vidofludimus calcium. I would like to thank BVF and the other investors in
the consortium for joining our journey towards potential regulatory approval of vidofludimus calcium. The proceeds from the initial closing
are expected to provide sufficient runway through submission of an NDA in the United States in mid-2027 and to start preparations for
the potential launch of vidofludimus calcium in RMS, as well as initiation of a phase 3 clinical program in PPMS,” commented Daniel
Vitt, Ph.D., Chief Executive Officer of Immunic. “We believe that now is the perfect time to prepare Immunic for its transformation
into a highly successful commercial entity. As Immunic evolves from an R&D-driven
organization into a fully-fledged commercial company, I have decided to return to my roots and focus my energy on further strengthening
Immunic’s scientific excellence. Together with our new interim Chairperson Simona and other members of our Board of Directors, I
look forward to welcoming a new CEO with a strong commercial background in the MS space to lead the next phase of Immunic’s growth
and to guide the potential launch of our first pharmaceutical product. I will continue to support this transition process and Immunic’s
success in my current and future executive roles and as a member of the Board of Directors.”
“I want to thank
Daniel for not only helping to invent vidofludimus calcium, but also for his tremendous leadership in getting the molecule and company
to this position,” said Duane Nash, M.D., J.D., M.B.A., member of the Immunic Board of Directors and former Chairman. “I am
also delighted that Simona has agreed to take the position of interim chairperson to steer this evolution. As the former head of Neuroscience
and Rare Diseases at Roche, who personally led one of the most successful launches in MS history, she is well positioned to guide Immunic’s
commercial transformation efforts. In the 18 months she has been on our Board, her contributions, insights and connections have proven
invaluable, and her leadership skills are impeccable. I look forward to helping support Simona and the rest of the Board in any way that
I can.”
“I am honored to
be in a position to help transform Immunic at this critical juncture,” said Simona Skerjanec, newly appointed interim Chairperson
of the Board of Directors of Immunic. “Despite available therapeutic options in MS, it remains a devastating disease for patients
and their families and I am committed to help bring new and meaningful therapies to patients. I believe vidofludimus calcium holds the
potential to address the underlying unmet need for a direct neuroprotective medicine in MS. I very much look forward to continuing to
work with Daniel, Duane and the rest of Immunic’s Board of Directors as we prepare Immunic for a very exciting future.”
Up to USD 400 Million Private Placement
The company has entered into a securities purchase
agreement with select accredited investors for up to USD 400 million in gross proceeds through a private placement. Pursuant to the terms
of the purchase agreement, the company will issue an aggregate of 229,076,000 pre-funded warrants to purchase shares of the company’s
common stock at a price of $0.873 per pre-funded warrant, for upfront gross proceeds of USD 200 million.
In addition, the company will issue warrants to
purchase up to an aggregate of 229,076,000 shares of the company’s common stock (or pre-funded warrants in lieu thereof) at an exercise
price of $0.873 per share, for up to an additional USD 200 million in gross proceeds to Immunic. These warrants will expire upon the earlier
of (a) 30 days after the public announcement of topline data from the phase 3 ENSURE trials or (b) February 17, 2031. The private placement
is expected to close on or about February 17, 2026, subject to customary closing conditions.
The financing was led by existing investor BVF
Partners L.P. and included participation from Aberdeen Investments, Avidity Partners, Coastlands Capital, EcoR1 Capital, Janus Henderson
Investors, OrbiMed, RA Capital Management, TCGX, Trails Edge Capital Partners, Vivo Capital, Woodline Partners LP, and other institutional
investors.
Leerink Partners acted as lead placement agent
in connection with the financing. Stifel, Guggenheim Securities, William Blair, LifeSci Capital, B. Riley Securities and Brookline Capital
Markets, a division of Arcadia Securities, LLC, also acted as placement agents in connection with the financing.
The company intends to use the net proceeds from
the offering to fund its clinical trials and operations and for other general corporate purposes. The proceeds from this private placement,
combined with current cash, cash equivalents and marketable securities, are expected to fund operating and capital expenditures to late
2027.
In addition, on February 12, 2026, Immunic entered
into a purchase and sale agreement with certain holders of warrants to purchase shares of the company’s common stock that were issued
in its May 2025 public offering (the “Series B Warrants”). Pursuant to the terms of the purchase and sale agreement, the company
issued to such holders the right to receive a portion of an aggregate 5% royalty on future net sales of vidofludimus calcium in exchange
for cancellation of the Series B Warrants held by such participants. The purchase and sale agreement is expected to close on or about
February 17, 2026.
Further information regarding the private placement
and the purchase and sale agreement can be found in the company’s filings with the Securities and Exchange Commission, including
a current report on Form 8-K which is expected to be filed on or about February 13, 2026.
About Immunic,
Inc.
Immunic, Inc. (Nasdaq:
IMUX) is a late-stage biotechnology company pioneering the development of novel oral therapies for neurologic and gastrointestinal 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 patients suffering from relapsing-remitting multiple sclerosis and progressive multiple sclerosis.
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 as well as inflammatory bowel disease, Graft-versus-Host-Disease
and weight management. 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
Note 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 consummation of the proposed offering and the exercise of warrants to be issued
in the offering, Immunic's development programs and the targeted diseases; the potential for vidofludimus calcium to safely and effectively
target diseases; preclinical and clinical data for vidofludimus calcium; the feasibility of advancing vidofludimus calcium to a confirmatory
phase 3 clinical trial in progressive multiple sclerosis; 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; and the development and commercial potential of
any product candidates 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, 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, the impact of competitive products and technological changes, the company’s ability
to close the proposed offering, and the risk that warrants issued in this offering will not be exercised for cash in the future. 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, 2024, filed with the SEC on March 31, 2025, 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