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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): April 26, 2023
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.
Item 5.02. Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers.
Yes ☐ No ☒ On April 27, 2023, Immunic, Inc. (the “Company”) announced the appointment of Dr. Richard Rudick as a member of the Board of Directors (the “Board”) of the Company, effective as of April 26, 2023. As a Class III director, Dr. Rudick’s term lasts until the Company’s 2023 Annual Meeting of Stockholders (the “Annual Meeting”). Dr. Rudick 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 Dr. Rudick and any other persons pursuant to which he was selected as a director.
In connection with his appointment as director, Dr. Rudick was granted a long-term equity incentive grant in the form of an option (the “Option”) to purchase a total of 32,000 shares of the Company’s common stock on April 26, 2023. The option to purchase 32,000 shares vests in monthly increments over a period of three years from the grant date. The Option will have an exercise price per share equal to the closing price of the Company’s common stock on The Nasdaq Stock Market on the date of grant.
Additionally, Dr. Rudick and the Company entered into the Company’s standard form of indemnification agreement for directors and executive officers.
Dr. Richard Rudick, age 72, has over 35 years of experience in the biopharmaceutical industry and academic medicine. Since January 2023, Dr. Rudick has been the President and CEO of Astoria Biologic, a private biotechnology company developing novel therapies for multiple sclerosis. Previously, Dr. Rudick served as the Vice President of Development Science at Biogen, Inc., a biotechnology company which engages in discovering, developing, and delivering therapies for neurological and neurodegenerative diseases, from May 2014 until September 2020. Dr. Rudick also served as a staff neurologist and director of the Mellen Center for the Cleveland Clinic from January 1987 until May 2014. Dr. Rudick holds an M.D. from Case Western Reserve University School of Medicine. The Nominating and Corporate Governance Committee and the Board believe that Dr. Rudick‘s extensive leadership in clinical research and development of multiple sclerosis treatments provides valuable clinical, strategy and management skills to the Board.
Effective on April 26, 2023, the Board determined that in connection with Dr. Rudick’s appointment, the size of the Board will be increased from seven to eight directors.
Director Not Standing for Re-Election at the 2023 Annual Meeting
Additionally, on April 26, 2023, Dr. Vincent Ossipow notified the Board that he plans to retire from the Board at the end of his current term and will not stand for re-election at the 2023 Annual Meeting. Dr. Ossipow will continue to serve as a member of the Board until the date of the Annual Meeting, and as a member of the Nominating and Corporate Governance Committee until the date of the Annual Meeting. Dr. Ossipow’s decision not to stand for re-election was not the result of any disagreement with the Company or its management on any matter relating to the Company’s operations, policies or practices.
The Company thanks Dr. Ossipow for his years of service and valuable contributions to the Company.
A copy of the press release announcing the foregoing matters is filed with this Form 8-K as Exhibit 99.1.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits.
|
Exhibit No.
|
Description of Exhibit
|
|
| 99.1 | Press release dated April 27, 2023. | |
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: April 27, 2023.
| Immunic, Inc. | ||
| By: | /s/ Daniel Vitt | |
| Daniel Vitt | ||
| President and Chief Executive Officer | ||
Immunic, Inc. Strengthens Its Board of Directors with the Appointment of Richard Rudick, M.D.
– Thought-Leader in Multiple Sclerosis with Decades of Experience in Academic Medicine and the Pharmaceutical Industry –
NEW YORK, April 27, 2023 – 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 Richard Rudick, M.D., a thought-leader in multiple sclerosis with decades of experience in the clinic, academia and industry, to its board of directors, effective April 26, 2023. The company also announced that Vincent Ossipow, Ph.D., will step down from the Board, effective June 28, 2023.
“We are very grateful to have Rick join us,” stated Duane Nash, M.D., J.D., M.B.A., Chairman of the Board of Directors of Immunic. “Rick has an extra-ordinary background spanning decades as a clinical expert in multiple sclerosis, clinical trialist who has overseen multiple successful pivotal studies, innovator and pharmaceutical executive. He has published extensively and been an active participant and leader in developing the current treatment landscape for multiple sclerosis. We look forward to working with him to leverage his extensive knowledge, experience and relationships, in particular, with respect to our ongoing development of vidofludimus calcium in multiple sclerosis, as well as our earlier programs.”
“On behalf of the entire Board of Directors, I would like to thank Vincent for his dedication to Immunic and his thoughtful guidance over the past seven years. We are deeply indebted to him for his invaluable contributions and offer him our best wishes in all future endeavors.”
Dr. Rudick is a Fellow of the American Academy of Neurology and served on the faculty of the Cleveland Clinic Foundation until 2014. While at the Cleveland Clinic, he was Director of the Mellen Center for Multiple Sclerosis Treatment and Research, Inaugural Chief Clinical Research Officer, Vice-Chair of the Cleveland Clinic Neuroscience Institute, and Co-Director of the city-wide Cleveland Clinical and Translational Science Collaborative. Between 2014 and 2020, Dr. Rudick served at Biogen as Director of the Value-Based Medicine Innovation Hub and Director of the Medical Evidence, Research and Innovation Unit. He has authored over 250 peer-reviewed publications in the neurology space, was Chair of the National Multiple Sclerosis Society Research Program Advisory Committee, and was a member of the Advisory Council to the National Center for Research Resources and the Director’s Council of Councils at the National Institutes of Health.
Dr. Rudick earned his medical degree from Case Western Reserve University School of Medicine, and completed clinical and research training at the University of Rochester.
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), currently in phase 3 clinical trials for the treatment of multiple sclerosis and which has shown therapeutic activity in phase 2 clinical trials in patients suffering from relapsing-remitting multiple sclerosis and moderate-to-severe ulcerative colitis, selectively inhibits activated immune cells and shows combined anti-inflammatory, anti-viral and neuroprotective effects. IMU-856 is targeted to restore intestinal barrier function and regenerate bowel epithelium, which would be applicable in numerous gastrointestinal diseases, such as celiac disease, where it is currently being evaluated in a clinical proof-of-concept trial. 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, expected development, 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 Immunic’s development programs to safely and effectively target diseases; the nature, strategy and focus of the company and further updates with respect thereto; expectations regarding the capitalization, resources and ownership structure of the company; 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, 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, 2022, filed with the SEC on February 23, 2023, 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
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