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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
20, 2025
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 8.01. Other Events.
On
February 20, 2025, Immunic, Inc. (the “Company” or “Immunic”) issued a press release (the “Press
Release”) and posted an updated corporate presentation on the Company’s website (the “Presentation”)
reporting on a post-hoc analysis of patients from its phase 1b clinical trial of IMU-856 in celiac disease, demonstrating a dose-dependent
increase of glucagon-like peptide-1 (GLP-1) levels. The Company also reported preclinical in vivo data showing a dose-dependent
reduction of body weight gain and food consumption for IMU-856. IMU-856
is an orally available and systemically acting small molecule modulator that targets SIRT6 (Sirtuin 6), a protein which serves as a transcriptional
regulator of intestinal barrier function and regeneration of bowel epithelium. The Company will discuss the data and the Presentation
during a live webinar event at 8:00 a.m. Eastern Time on February 20, 2025, and during a digital oral presentation at the 19th Congress
of European Crohn's and Colitis Organisation at 11:57 a.m. Eastern Time on February 20, 2025.
The Press Release and Presentation are attached
as Exhibits 99.1 and 99.2 to this Current Report on Form 8-K, respectively, and are incorporated herein by reference.
Item 9.01. Financial Statements and Exhibits.
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 20, 2025 |
Immunic, Inc. |
| |
|
|
| |
By: |
/s/ Daniel Vitt |
| |
|
Daniel Vitt |
| |
|
Chief Executive Officer |
Immunic’s Oral IMU-856
Demonstrated Dose-Dependent Increase of GLP-1 in Celiac Disease Patients and Corresponding Effects in Preclinical Testing
– New Data Suggests
that IMU-856 Could Be a Potential Oral Treatment Option for Weight Management; Program Is Phase 2 Ready –
– Dose-Dependent Increase
of Endogenous GLP-1 Levels Observed in Post Hoc Analysis of Patients From Phase 1b Clinical Trial in Celiac Disease –
– Dose-Dependent Reduction
of Body Weight Gain and Food Consumption Observed in Preclinical Study –
– Webcast to be Held
Today, February 20 at 8:00 am ET –
NEW YORK, February 20, 2025 – 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 that IMU-856, an orally available and systemically acting small molecule
modulator that targets SIRT6 (Sirtuin 6), demonstrated a dose-dependent increase of endogenous glucagon-like peptide-1 (GLP-1) levels
in a post hoc analysis of patients from its phase 1b clinical trial in celiac disease. IMU-856 also showed a dose-dependent reduction
of body weight gain and food consumption in preclinical in vivo testing. These effects may indicate the potential for IMU-856 as
an oral treatment option for weight management.
“GLP-1, a hormone that occurs naturally
in the gut, is released after eating and helps the body regulate blood sugar and satiety. It plays several critical roles, including triggering
insulin release from the pancreas and blocking glucagon, a hormone raising blood sugar. Additionally, GLP-1 affects areas of the brain
that process hunger and satiety,” noted Hella Kohlhof, Ph.D., Chief Scientific Officer of Immunic. “IMU-856’s target,
SIRT6, is highly expressed in cells of the bowel wall, including enteroendocrine cells, which produce gastrointestinal hormones such as
GLP-1 and gastric inhibitory peptide (GIP). Our phase 1b clinical trial in celiac disease patients demonstrated IMU-856’s ability
to regenerate epithelial cells, as measured by protection of villous height and improved cellular function. The current observations of
increased GLP-1 in these celiac disease patients and the preclinical signs of reduced body weight gain indicate that IMU-856 may also
have the effect of activating the function of enteroendocrine cells. These findings corroborate the tissue renewal effects already seen
for IMU-856 and warrant continued evaluation, as they may meaningfully expand the potential indications for IMU-856.”
New data is available from a post hoc analysis
of the company’s phase 1b clinical trial of IMU-856 in celiac disease patients, where blood concentrations of GLP-1 were measured,
between baseline and day 28, in a fasting state. A highly statistically significant (day 29: 80 mg p=0.014; 160 mg p=0.003) and dose-dependent
increase of GLP-1 versus placebo control was detectable, even in the small patient population in this phase 1b clinical trial (baseline:
N placebo = 11, N 80 mg IMU-856 = 13, N 160 mg IMU-856 = 13). These clinical findings were corroborated by effects observed in a 6-month
preclinical in vivo study, where IMU-856 was found to reduce body weight gain accompanied by food consumption in a dose-dependent
fashion up to -40 %, compared to the control group, which was found to be linked to reduced food intake.
“This newly released clinical and preclinical
data demonstrating IMU-856’s potential positive effect on GLP-1 and food consumption is an exciting development for Immunic’s
oral small molecule program,” stated Daniel Vitt, Ph.D., Chief Executive Officer of Immunic. “Data from our phase 1b clinical
trial in celiac disease patients showed, under fasting conditions, a dose-dependent increase of naturally occurring GLP-1 levels of up
to 250 % versus placebo. This compares favorably to the typical physiological 2-3 times increase in GLP-1 in healthy humans after a meal,
indicating that IMU-856 may replicate the natural effect after eating. While currently available incretin mimetics delivered via subcutaneous
injection are focused on one or two enteroendocrine hormones, we hypothesize that the SIRT6 modulation approach may result in a broader,
more physiologic activation of enteroendocrine hormones, which we plan to explore further. If the effects reported today can be confirmed
in further clinical trials, our convenient, once-daily small molecule tablet may represent an oral treatment option for obesity –
a market with millions of people affected worldwide and which is expected to reach more than $170 billion globally by 2031. Our IMU-856
program offers the potential for immediate phase 1b or phase 2 clinical testing. As such, we will continue to analyze the findings and
assess any next steps.”
Webcast and Presentation Information
Immunic will host a webcast today at 8:00 am ET.
To participate in the webcast, please register in advance at: https://imux.zoom.us/webinar/register/WN_o9yQAoqtT3yWnjb0049_Dw
or on the “Events and Presentations” section of Immunic’s website at ir.imux.com/events-and-presentations.
Registrants will receive a confirmation email containing a link for online participation or a telephone number for dial in access.
An archived replay of the webcast will be available
approximately one hour after completion on Immunic’s website at ir.imux.com/events-and-presentations.
Today’s update, along with phase 1b biomarker
data for IMU-856, will also be presented as a digital oral presentation at the 19th Congress of ECCO (European Crohn's and Colitis Organisation).
The presentation will be accessible on the “Events and Presentations” section of Immunic’s website at: https://ir.imux.com/events-and-presentations.
| · | Presentation Title: Promising Effects of IMU-856, an Orally Available Epigenetic Modulator of
Barrier Regeneration - Biomarker Findings from a Phase 1 Clinical Study |
| · | Presenting Author: Amelie Schreieck, Ph.D., Senior Manager Biomarker Development, Immunic |
| · | Abstract Number: EC25-1515 |
| · | Presentation Number: DOP012 |
| · | Presentation Time: 5:57 pm – 6:03 pm CET |
| · | Session Name: Digital Oral Presentation (DOP) Session 2: Clinical Trials II |
| · | Session Date: February 20, 2025 |
About IMU-856
IMU-856 is an orally available and systemically
acting small molecule modulator that targets SIRT6 (Sirtuin 6), a protein which serves as a transcriptional regulator of intestinal barrier
function and regeneration of bowel epithelium. Based on preclinical data, the compound may represent a unique treatment approach, as the
mechanism of action targets the restoration of the intestinal barrier function and bowel wall architecture in patients suffering from
gastrointestinal diseases such as celiac disease, inflammatory bowel disease and other intestinal barrier function associated diseases.
Based on preclinical investigations demonstrating no suppression of immune cells, IMU-856 may have the potential to maintain immune surveillance
for patients during therapy, which would be an important advantage versus immunosuppressive medications. IMU-856 demonstrated positive
results in a phase 1b clinical trial in celiac disease patients in four key dimensions of the disease’s pathophysiology: histology,
disease symptoms, biomarkers and nutrient absorption. In a post hoc analysis of patients from the phase 1b clinical trial, IMU-856 demonstrated
a dose-dependent increase of endogenous glucagon-like peptide-1 (GLP-1) levels and, in preclinical testing, showed a dose-dependent reduction
of body weight gain and food consumption, indicating potential as a possible oral treatment option for weight management. The company
is currently preparing for further clinical testing. IMU-856 is an investigational drug product that has not been approved in any jurisdiction.
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 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 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 IMU-856
to safely and effectively target diseases or to reduce body weight gain and food consumption; other preclinical and clinical data for
IMU-856; 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, the COVID-19 pandemic, 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, including the ability
to satisfy the minimum average price and trading volume conditions required to receive funding in tranche 2 and 3 of the January 2024
private placement, 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, 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 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
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