# EDGAR Filing Document

**Accession Number:** 0001280776
**File Stem:** 0001193805-23-000100
**Filing Date:** 2023-2
**Character Count:** 15761
**Document Hash:** da4720e21b7aa61e099ca52ef1eb831c
**Contains OCR:** False
**Source Format:** 

## Filing Content

## Filing Summary
**0001193805-23-000100.hdr.sgml**: 20230209

**ACCESSION NUMBER**: 0001193805-23-000100

**CONFORMED SUBMISSION TYPE**: 8-K

**PUBLIC DOCUMENT COUNT**: 88

**CONFORMED PERIOD OF REPORT**: 20230209

**ITEM INFORMATION**: Other Events

**ITEM INFORMATION**: Financial Statements and Exhibits

**FILED AS OF DATE**: 20230209

**DATE AS OF CHANGE**: 20230209

**FILER**: 

**COMPANY DATA:**
- **COMPANY CONFORMED NAME:** IMMUNIC, INC.
- **CENTRAL INDEX KEY:** 0001280776
- **STANDARD INDUSTRIAL CLASSIFICATION:** PHARMACEUTICAL PREPARATIONS [2834]
- **IRS NUMBER:** 562358443
- **STATE OF INCORPORATION:** DE
- **FISCAL YEAR END:** 1231

**FILING VALUES:**
- **FORM TYPE:** 8-K
- **SEC ACT:** 1934 Act
- **SEC FILE NUMBER:** 001-36201
- **FILM NUMBER:** 23601050

**BUSINESS ADDRESS:**
- **STREET 1:** 1200 AVENUE OF THE AMERICAS
- **STREET 2:** SUITE 200
- **CITY:** NEW YORK
- **STATE:** X1
- **ZIP:** 10036
- **BUSINESS PHONE:** (332) 255-9818

**MAIL ADDRESS:**
- **STREET 1:** 1200 AVENUE OF THE AMERICAS
- **STREET 2:** SUITE 200
- **CITY:** NEW YORK
- **STATE:** X1
- **ZIP:** 10036

**FORMER COMPANY:**
- **FORMER CONFORMED NAME:** VITAL THERAPIES INC
- **DATE OF NAME CHANGE:** 20040219

?xml version="1.0" encoding="utf-8"?

**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 9, 2023**

**IMMUNIC, INC.**

**(Exact name of registrant as specified in its charter)**

---

| | | |
|:---|:---|:---|
| **Delaware** | **001-36201** | **56-2358443** |
| **(State or other jurisdiction<br> 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 9, 2023, Immunic, Inc. (the "Company") issued a press release and presentation announcing a virtual celiac disease R&D webcast to highlight the current pathways for drug development, the current and potential treatment options and the unmet medical need for effective therapeutics. The company announced that initial results from the Part C portion of the ongoing phase 1 clinical trial of IMU-856 in celiac disease patients are expected to be available in mid-2023. The press release and presentation are attached as Exhibits 99.1 and 99.2 to this Current Report on Form 8-K and are incorporated herein by reference.

**Item 9.01. Financial Statements and Exhibits**

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| | |
|:---|:---|
| **Exhibit** | **Description** |
| 99.1 | [Press Release, dated February 9, 2023.](e618255_ex99-1.htm) |
| 99.2 | [Presentation, dated February 9, 2023.](e618255_ex99-2.htm) |
| 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: February 9, 2023 | **Immunic, Inc.** | **Immunic, Inc.** |
|  | By: | /s/ Daniel Vitt |
|  |  | Daniel Vitt |
|  |  | Chief Executive Officer |

---

## Exhibit 99.1

![](image_001.jpg)

**Immunic to Host Virtual Celiac Disease R&D Day to Highlight Current Pathways for Drug Development and Unmet Medical Need**

*– Conference Call and Webcast to be Held Today, February 9, 2023, at 11:00 am ET –*

**NEW YORK, February 9, 2023 – Immunic, Inc. (Nasdaq: IMUX),** a clinical-stage biopharmaceutical company developing a pipeline of selective oral immunology therapies focused on treating chronic inflammatory and autoimmune diseases, announced that its Celiac Disease R&D Webcast will take place today, February 9, 2023 from 11:00 am to 1:00 pm ET.

Management of Immunic, including Daniel Vitt, Ph.D., Chief Executive Officer and President; Andreas Muehler, M.D., M.B.A., Chief Medical Officer; and Hella Kohlhof, Ph.D., Chief Scientific Officer, will be joined by renowned key opinion leaders to discuss the dynamics of this multifactorial, complex autoimmune disease, immune stimulation and its connection to clinical symptoms, the role of the epithelial barrier in the pathogenesis of the disease, current and potential treatment options, and the continued unmet medical need for effective therapeutics, which is driving an increased focus within the industry.

Featured key opinion leaders will be:

· Joseph A. Murray, M.D., Professor of Medicine,
Director, Celiac Disease Research, John and Shirley Berry Professor of Gastrointestinal Sciences, Division of Gastroenterology and Hepatology,
Department of Internal Medicine, Mayo Clinic, Rochester, MN

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;o Joseph A. Murray will discuss the role of the innate and adaptive immune system in celiac disease. He
will focus on the relevance of the pro-inflammatory cytokine interleukin-2 (IL-2) as objective biomarker that correlates with onset and
severity of symptoms after gluten exposure and its relevance for clinical celiac disease trials.

· Michael Schumann, M.D., Attending Physician in Internal Medicine and Gastroenterology, Department of Gastroenterology,
Infectious Diseases and Rheumatology, Campus Benjamin Franklin, Charité – Universitätsmedizin Berlin

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;o Michael Schumann will discuss the role of the intestinal barrier function in the pathophysiology of celiac
disease by dissecting paracellular and transcellular mechanisms. He will present research results from preclinical models investigating
tight junction assembly defects impacting paracellular transport and will provide insights into altered transcellular passage of gliadin
fragments.

"We look forward to hosting this deep-dive discussion, focused on the current challenges of treating celiac disease with two, such renowned thought leaders as Drs. Murray and Schumann," stated Daniel Vitt, Ph.D., Chief Executive Officer and President of Immunic. "The only current treatment option for celiac patients is life-long, strict adherence to a gluten-free diet, yet many of those who follow such a protocol still experience persistent disease activity, leading to a significant unmet need for this patient population. With the participation of these two key opinion leaders, this event will help to illuminate the most important issues being considered by the industry, today. Immunic, itself, remains committed to its research in this area and we currently expect to provide initial results from the Part C portion of our ongoing phase 1 clinical trial of IMU-856 in celiac disease patients, in mid-2023."

![](image_001.jpg)

**Webcast Information**

The Celiac Disease R&D Day webcast will be held virtually via Zoom. To participate, please register in advance at: https://imux.zoom.us/webinar/register/WN_wI-01YeJSbe4XRTFO1PLQw.

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.

**About Celiac Disease**

Celiac disease is a multifactorial, complex autoimmune disease caused by an inappropriate immune reaction against a degradation product of gluten in genetically susceptible individuals. It is characterized by small intestinal epithelial injury, elevated intestinal permeability, and nutrient malabsorption. Celiac disease causes debilitating signs and symptoms of malabsorption such as diarrhea, steatorrhea, fatigue, weight loss, anemia, osteopenia, and can lead to serious complications such as enteropathy-associated T-cell lymphoma. In children, nutrient malabsorption can affect growth and development, in addition to causing the symptoms seen in adults. There is currently no known cure or treatment for celiac disease and patients must adhere to a strict, life-long gluten-free diet which can help manage symptoms and avoid disease flareups. Celiac disease is estimated to affect 1 in 100 people, worldwide. In the U.S., alone, it is estimated that 2.5 million people are undiagnosed and are, therefore, at risk for long-term health complications.

**About Immunic, Inc.**

Immunic, Inc. (Nasdaq: IMUX) is a clinical-stage biopharmaceutical company with a pipeline of selective oral immunology therapies focused on treating chronic inflammatory and autoimmune diseases. The company is developing three small molecule products: its lead development program, vidofludimus calcium (IMU-838), a selective immune modulator that inhibits the intracellular metabolism of activated immune cells by blocking the enzyme DHODH and exhibits a host-based antiviral effect, is currently being developed as a treatment option for multiple sclerosis. IMU-935, a selective inverse agonist of the transcription factor RORγ/RORγt, is targeted for development in psoriasis, and castration-resistant prostate cancer. IMU-856, which targets the restoration of the intestinal barrier function, is targeted for development in diseases involving bowel barrier dysfunction and regeneration of bowel epithelium. For further information, please visit: www.imux.com.

![](image_001.jpg)

**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, expected timing 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 three development programs and the targeted diseases; the potential for IMU-856 to safely and effectively target diseases; interpretation of preclinical and clinical data for IMU-856 and potential effects; 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 on 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, 2021, filed with the SEC on February 24, 2022, 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**

<br> **Immunic, Inc.**

Jessica Breu

Head of 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

## Exhibit 99.2

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