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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): July 9, 2024
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.
Appointment of Jason Tardio as Chief Operating Officer and President
On July 9, 2024, Immunic, Inc. (the “Company”) announced the appointment of Jason Tardio as Chief Operating Officer and President, effective July 12, 2024. In this newly created position at the Company, Mr. Tardio will be responsible for directing corporate efforts to prepare for the potential launch of vidofludimus calcium (IMU-838), the Company’s orally available nuclear receptor related 1 (Nurr1) activator. In fulfilling his several duties and responsibilities, Mr. Tardio is expected to collaborate with Mr. Patrick Walsh, Chief Business Officer, among other officers of the Company, to prepare the Company for a range of potential partnership outcomes.
In connection with his appointment as Chief Operating Officer and President, Mr. Tardio will receive a yearly base salary of $500,000, subject to periodic review and adjustments made by the Company, and be eligible for a yearly bonus amount of up to 40 percent of the yearly base salary upon achievement of certain individual and company goals. In addition, the Company will pay Mr. Tardio a signing bonus in the amount of $120,000, 50 percent payable in the first month and 50 percent payable after six months of employment.
Mr. Tardio is also entitled to a severance payment equivalent to twelve months of Mr. Tardio’s yearly base salary if (i) Mr. Tardio were to be terminated without “cause” (as such term is defined in the employment agreement to be entered into with Mr. Tardio), or (ii) the Company were to elect not to renew the term of Mr. Tardio’s employment with the Company.
The Company will recommend that the Company’s board of directors grant to Mr. Tardio an initial equity option to purchase a maximum of 500,000 shares of common stock of the Company (the “Options”), the provisions of which will be set forth in a separate agreement by and between the Company and Mr. Tardio. The Options will be time vested, with 25 percent of the Options vesting on the one-year anniversary of the grant and the remaining 75 percent vesting in equal monthly installments over a period of three years from the first anniversary of the grant date.
Previously, Mr. Tardio, age 47, was Chief Operating Officer of Ovid Therapeutics Inc. since June 2021, after joining the firm as Chief Commercial Officer in November 2019. Prior to his role at Ovid Therapeutics, Inc., Mr. Tardio served as Vice President, Head of the Multiple Sclerosis Franchise at Novartis AG from September 2018 to November 2019. Before his employment at Novartis, Mr. Tardio worked for nine years in several capacities at Biogen Inc., where he most recently served as General Manager, Managing Director for the firm’s Latin America South affiliate. Mr. Tardio commenced his career in the biopharmaceutical industry at Wyeth Pharmaceuticals Inc. and Sepracor, Inc., respectively, in various sales, sales training, and marketing roles.
Mr. Tardio holds a Bachelor of Science from The College of New Jersey and an MBA in Pharmaceutical Marketing from St. Joseph’s University.
There are no arrangements or understandings between Mr. Tardio and any other persons pursuant to which he was appointed as Chief Operating Officer and President. There are also no family relationships between Mr. Tardio and any director or executive officer of the Company, and except as previously disclosed, he has no direct or indirect material interest in any transaction required to be disclosed pursuant to Item 404(a) of Regulation S-K.
Promotion of Werner Gladdines to Chief Development Officer
On July 9, 2024, the Company announced the promotion of Werner Gladdines from Vice President, Program Management & Clinical Development Operations to Chief Development Officer of the Company. In his new role as Chief Development Officer, Mr. Gladdines is expected to oversee the Company’s overall clinical operations functions.
In January 2021, Mr. Gladdines joined the Company as Head of the IMU-838 Program and has held various roles at the Company with significant responsibilities.
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.
| Exhibit No. | Description of Exhibit |
| 99.1 | Press release dated July 9, 2024. |
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: July 9, 2024 |
Immunic, Inc. | |
| By: | /s/ Daniel Vitt | |
| Daniel Vitt | ||
| Chief Executive Officer | ||
Immunic Appoints Jason Tardio as Chief Operating Officer and President
– Former Novartis and Biogen Executive Brings Extensive Multiple Sclerosis Drug Commercialization Experience to Immunic –
– Werner Gladdines, Current Vice President, Program Management & Clinical Development Operations, Promoted to Chief Development Officer –
NEW YORK, July 9, 2024 – 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 seasoned biopharmaceutical executive, Jason Tardio, will be joining the company as Chief Operating Officer and President, effective July 12, 2024. In the newly created role, Mr. Tardio will lead internal efforts to prepare for the potential launch of vidofludimus calcium (IMU-838), the company’s orally available nuclear receptor related 1 (Nurr1) activator. Jason will also work closely with Patrick Walsh, Chief Business Officer, to prepare the company for a range of potential partnership outcomes for vidofludimus calcium, as well as Immunic’s other drug candidates.
“Jason’s extensive experience, most notably related to the launch and commercialization of successful multiple sclerosis (MS) drugs for both Novartis and Biogen, as well as his history of significant out-licensing transactions provide Immunic with an invaluable and proven skill as we draw closer to completion of vidofludimus calcium’s phase 3 ENSURE program,” stated Daniel Vitt, Ph.D., Chief Executive Officer of Immunic. “Jason’s appointment reflects our commitment to both commercial and partnership preparedness and comes at a particularly important and exciting time with the upcoming read-out of our phase 2 CALLIPER trial in progressive MS expected in April 2025 and the completion of our twin phase 3 ENSURE trials in relapsing MS expected in the second quarter and the second half of 2026, respectively. We warmly welcome him to Immunic.”
Mr. Tardio added, “I am thrilled to join Immunic’s very talented team and am particularly enthusiastic about the potential to bring such a groundbreaking and much-needed oral treatment option to patients with relapsing and also progressive forms of MS, where patients have few options and there continues to be a huge unmet need. With its compelling dual mechanism of action, as well as its combined neuroprotective, anti-inflammatory, and antiviral effects, vidofludimus calcium has the potential to meaningfully enhance therapeutic options and also tap enormous markets. I look forward to applying my years of experience in this indication to support the drug’s ultimate commercial success, assuming future regulatory approval.”
Mr. Tardio most recently served as Chief Operating Officer of Ovid Therapeutics Inc. since June 2021, after joining the company as Chief Commercial Officer in November 2019. While there, he led all functions of Ovid’s commercial business, with an emphasis in transitioning the company from a pre-commercial entity into a fully integrated and program-oriented commercial enterprise. Previously, Mr. Tardio served as Vice President, Head of the Multiple Sclerosis Franchise at Novartis AG from September 2018 to November 2019, a business unit with annual revenues of more than $3 billion, where he successfully launched MAYZENT® (siponimod)* and was responsible for developing and managing all aspects of the U.S. commercial plan, brand P&L, strategy development and go-to-market modeling for the Novartis MS franchise. Before Novartis, Mr. Tardio spent nine years in positions of increasing responsibility at Biogen Inc., where he most recently served as General Manager, Managing Director for Biogen’s Latin America South affiliate. Earlier at Biogen, Mr. Tardio held a wide range of sales and marketing roles, including positions in global commercial strategy, the U.S. business unit and the international affiliates, where he played a key role in launching both the AVONEX® PEN (interferon beta-1a)* and PLEGRIDY® (peginterferon beta-1a)* for relapsing forms of MS. Mr. Tardio’s more than two decades of experience in the biopharmaceutical industry began at Wyeth Pharmaceuticals Inc. and Sepracor, Inc., with various roles in sales, sales training and marketing. He holds a Bachelor of Science from The College of New Jersey and an MBA in Pharmaceutical Marketing from St. Joseph’s University.
The company also reported that Werner Gladdines, current Vice President, Program Management & Clinical Development Operations, has been promoted to Chief Development Officer. Mr. Gladdines joined Immunic in January 2021 as Head of the IMU-838 Program. Since then, he has held positions of increasing responsibility and was appointed Vice President, Program Management & Clinical Development Operations in February 2023. In his new role as Chief Development Officer, Mr. Gladdines will take over additional strategic and operational responsibility for Immunic’s overall clinical operations functions.
* MAYZENT® is a registered trademark of Novartis AG; AVONEX® and PLEGRIDY® are registered trademarks of Biogen
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, for which it is currently in preparations for a phase 2 clinical trial. 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 new management hires and promotions, strategy, future operations, future financial position, future revenue, projected expenses, sufficiency of cash, 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 and anticipated clinical milestones; 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; 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 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, 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 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
KOGS Communication
Edna Kaplan
+1 617 974 8659
kaplan@kogspr.com