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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):
March 31, 2021
IMMUNIC, INC.
(Exact name of registrant as specified in its
charter)
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Delaware
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001-36201
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56-2358443
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(State or other jurisdiction
of incorporation)
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(Commission File Number)
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(IRS Employer Identification No.)
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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:
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☐
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Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
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☐
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Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
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☐
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Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
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☐
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Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
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Securities registered pursuant to Section 12(b) of the Act:
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Title of each class
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Trading Symbol(s)
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Name of exchange on which registered
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Common Stock, par value $0.0001
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IMUX
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The Nasdaq Stock Market LLC
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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.
On March 31, 2021, Immunic AG, a wholly-owned subsidiary
of Immunic, Inc. (the “Company”), and 4SC AG (“4SC”) entered into a Settlement Agreement (the “Agreement”),
pursuant to which Immunic AG will settle its remaining obligation of a 4.4% royalty for $17.25 million. The payment
will be made 50% in cash and 50% in shares of Immunic’s common stock (the “Shares”). Pursuant to the Agreement,
the Company will use commercially reasonable efforts to file and have declared effective a resale shelf registration statement on Form
S-3 covering the resale of the Shares.
Immunic AG acquired IMU-838 from 4SC AG pursuant
to an Asset Purchase Agreement dated May 13, 2016. With the execution of the Agreement, no further payment obligations remain between
Immunic AG and 4SC.
On March 31, 2021, the Company issued a press release
announcing the execution of the Agreement. The Agreement and the press release are attached as Exhibits 10.1 and 99.1 to this Current
Report on Form 8-K and are incorporated herein by reference.
Item 3.02. Unregistered Sales of Equity Securities.
The information set forth in Item 1.01 of this Current
Report on Form 8-K is hereby incorporated by reference into this Item 3.02 in its entirety.
The issuance and sale of the Shares has not been
registered under the Securities Act. The Shares have been sold and issued in reliance on an exemption from the registration requirements
of the Securities Act afforded by Section 4(a)(2) thereof and Rule 506 of Regulation D thereunder.
None of the Shares may be offered or sold in the
United States absent registration under or exemption from the Securities Act and any applicable state securities laws. This Current Report
on Form 8-K is not an offer to sell or the solicitation of an offer to buy any such Shares.
Item 9.01. Financial Statements and Exhibits
* Certain confidential portions of this exhibit have been redacted
from the publicly filed document because such portions are (i) not material and (ii) would be competitively harmful if publicly disclosed.
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.
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Dated: March 31, 2021
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Immunic, Inc.
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By:
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/s/ Daniel Vitt
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Daniel Vitt
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Chief Executive Officer
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Exhibit 10.1
CERTAIN INFORMATION IDENTIFIED BY BRACKETED
ASTERISKS ([* * *]) HAS BEEN OMITTED FROM THIS EXHIBIT BECAUSE IT IS BOTH NOT MATERIAL AND WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY
DISCLOSED.
Settlement Agreement
by and between
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1.
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4SC AG, with registered seat at Fraunhoferstr. 22, 82152 Planegg-Martinsried, Germany and registered
with the commercial register of the local court of Munich under HRB 132917
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the “Seller“ -
and
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2.
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Immunic AG, with registered seat at Lochhamer Schlag 21, 82166 Gräfelfing, Germany and registered
with the commercial register of the local court of Munich under HRB 223333
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the “Buyer“ –
and
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3.
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Immunic, Inc. with registered seat at 1200 Avenue of the Americas, Suite 200, 2 New York, NY 10036,
United States
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“IMUX“ –
- the Seller, the Buyer and IMUX
jointly also “Parties” and individually “Party” -
Preamble
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A.
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On 13 May 2016 the Seller and the Buyer entered into an asset purchase agreement (“APA”)
pursuant to which Seller sold and transferred certain assets to the Buyer such as, inter alia, the rights to patent applications
and patents, the right to apply for and register trademarks on the sold assets and know-how pertaining to the sold assets (“Sold
Assets”). Unless otherwise stated herein, capitalized terms used in this Agreement shall have the meanings given to them in
the APA, a copy of which is attached to this Agreement as Annex A.
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B.
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Pursuant to Section 5 para. 1 of the APA, the aggregate purchase price for the Sold Assets was, or will
become, due for payment to the Seller in four (4) tranches. Tranche 1 equaling EUR 2 million was paid to Seller and got fully satisfied
by the Buyer on 28 September 2016 and Tranche 2 amounting to EUR 1 million was paid to Seller and was fully satisfied by Buyer on
15 December 2017. Tranche 4 was settled in April 2019 in accordance with a settlement agreement between the Seller and the Buyer dated
11 April 2019.
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C.
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According to the APA, Tranche 3 amounts to 4.4% of the aggregate Net Sales generated for a certain period,
as specified in Section 5 para. 1 lit. (c) of the APA, and is payable on a quarterly basis within 30 days after the end of each calendar
quarter, as specified in Section 5 para. 4 lit. (c) of the APA. The Seller and the Buyer are in agreement that the conditions for
payment of Tranche 3 pursuant to the APA have not been fulfilled yet, but the Seller and the Buyer now intend to finally settle Tranche
3 as set out in this settlement agreement (“Agreement”).
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Now therefore, the Parties enter into this Agreement:
§ 1
Settlement of Tranche 3
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1.
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The Seller shall receive from the Buyer
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a.
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USD 8,625,000 in cash (the “Cash Component”); and
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b.
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a number of shares of common stock of IMUX par value USD 0.0001 per share (“Common Stock”),
with a value equal to USD 8,625,000 (the “Settlement Shares”).
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as compensation for the final settlement
of the payment obligation of the Buyer with respect to Tranche 3 under the APA (“Settlement Compensation”).
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2.
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The Settlement Compensation shall become due two (2) trading days after the execution of this Agreement
(“Due Date”). Section 5 no. 13 of the APA shall apply mutatis mutandis for the payment of the Settlement Compensation.
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3.
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The board of directors of IMUX, the sole shareholder of the Buyer, has consented to the execution of the
Buyer of this Agreement and the distribution of the Settlement Compensation; the consent is attached hereto as Annex 1.3.
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4.
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The Seller’s supervisory board has consented to the execution of the Seller of this Agreement; the
consent is attached hereto as Annex 1.4.
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§ 2
Cash Component
The payment regarding the Cash Component shall
be paid on the Due Date by wire transfer in immediately available funds, free of any costs and charges, to the following bank account
of the Seller:
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Account owner:
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[***]
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Account number:
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[***]
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Bank:
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[***]
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SWIFT (BIC):
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[***]
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IBAN:
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[***]
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§ 3
Settlement Shares
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1.
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The number of Settlement Shares shall be calculated and based on the average closing price of the Common
Stock of IMUX on the Nasdaq Global Market over the 10 trading days prior to the execution of this Agreement, which amounts to 581,199.
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2.
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The Settlement Shares shall be delivered on the Due Date to the Seller:
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Account owner:
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[***]
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Account number:
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[***]
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Bank
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[***]
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SWIFT (BIC)
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[***]
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IBAN
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[***]
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3.
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The Settlement Shares will be issued in book-entry form to the Seller in a private placement on the Due
Date and the Seller understands that, until such time as the Settlement Shares have been sold pursuant to a Registration Statement (as
such term is defined in below) or the Settlement Shares may be sold pursuant to Rule 144 (promulgated under the under the Securities Act
of 1933, as amended) without any restriction as to the number of securities as of a particular date that can then be immediately sold,
the book entry notations evidencing the Shares Settlement Shares will include customary legends, including the following:
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“THE SECURITIES REPRESENTED HEREBY HAVE
NOT BEEN REGISTERED UNDER THE SECURITIES ACT OF 1933, AS AMENDED (THE “ACT”), OR UNDER THE SECURITIES LAWS OF CERTAIN STATES.
THESE SECURITIES ARE SUBJECT TO RESTRICTIONS ON TRANSFERABILITY AND RESALE AND MAY NOT BE TRANSFERRED OR RESOLD EXCEPT (1) AS PERMITTED
UNDER THE ACT AND ANY APPLICABLE STATE SECURITIES LAWS, PURSUANT TO REGISTRATION OR EXEMPTION THEREFROM, (2) UNLESS IMMUNIC, INC. HAS
RECEIVED AN OPINION OF COUNSEL SATISFACTORY TO IMMUNIC, INC. AND ITS COUNSEL THAT SUCH REGISTRATION IS NOT REQUIRED OR (3) UNLESS SOLD
PURSUANT TO RULE 144 OF THE ACT OR OTHER EXEMPTION FROM REGISTRATION.”
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4.
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The Parties agree that
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a.
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they will execute and deliver without undue delay after the Signing of this Agreement a customary U.S.
law governed Registration Rights Agreement substantially in the form as set out in Annex 3.4 pursuant to which IMUX will
agree to use its commercially reasonable efforts to file a resale shelf registration statement on Form S-3 (“S-3 Statement”)
and to have such registration statement declared effective by the U.S. Securities Exchange Commission; and
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b.
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the sale of the Settlement Shares will be made strictly in compliance with applicable U.S. Securities
laws, whereby the Buyer hereby assures that the sale of the Settlement Shares can effectively take place in compliance with such laws.
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§ 4
Settlement
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1.
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With receipt of the full Settlement Compensation, all claims of any kind of the Seller relating to Tranche
3 and under and in connection with the APA, including but not limited to, equitable adjustments, interest and other remedies requested
in the APA in connection with Tranche 3 shall be deemed as irrevocably settled in full.
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2.
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Subject to the condition precedent (aufschiebende Bedingung) of the transfer of the Settlement
Shares and the payment of the Cash Component to the Seller, the Seller hereby waives any rights to enforce its rights under Section 5
para. 1 lit. (c) of the APA in connection with Tranche 3. The Buyer hereby already accepts such waiver in its own name as well as on behalf
of its shareholders.
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§ 5
Date of Effect
This Agreement comes into force and effect on
the day the Parties sign this Agreement. Signing will be effective if several identical copies of this Agreement are produced and each
Party signs the versions determined for the respective other Parties (Sec. 126 para. 2 sentence 2 BGB) and such signed copies are delivered
(zugehen) to the other Parties (possibly via facsimile or as a pdf-copy).
§ 6
Non-Assignment
The rights of the Parties under this Agreement
may not be assigned without the express written consent of the other Party, which consent may be given only in accordance with applicable
law and regulation, but not to be unreasonably withheld.
§ 7
Confidentiality / Public Disclosure / Fees
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1.
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Neither this Agreement itself nor its substance shall be disclosed to any third person except those who
are in a confidential relationship to a Party (such as legal counsel), or where the same is required by law and then only on a basis that
it not be further disclosed.
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2.
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No Party shall issue any statement or communication to any third party (other than their respective agents
who shall be subject to the confidentiality obligations described above) regarding this Agreement and the Settlement Compensation, without
the consent of the other Party, except that this restriction shall be subject to any obligations to comply with applicable securities
laws and the rules of any stock market or exchange where their shares are listed for trading, and except for an ad-hoc disclosure by the
Seller as on the date of this Agreement a draft of which will be attached hereto as Annex 7.
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3.
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Each Party shall bear its own costs incurred by it and the costs and fees of its advisors in connection
with the preparation, negotiation and execution of this Agreement.
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§ 8
Miscellaneous
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1.
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The failure of any Party to exercise any of its rights under this Agreement shall not constitute a waiver
of its rights unless such Party has explicitly waived its right in writing.
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2.
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Changes or amendments to this Agreement must be made in writing. The same shall apply to a dispensing
of the requirement of written form. The written form shall be deemed fulfilled if the declaring Party provides a personally signed document
via facsimile or as a pdf-copy to the recipient.
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3.
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This Agreement is subject to the law of the Federal Republic of Germany under exclusion of the conflict
of law provisions and the CISG.
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4.
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All claims and disputes arising out of this Agreement shall be governed, as far as legally permissible,
by the courts of Munich (Landgericht München I).
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5.
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Should any individual terms of this Agreement are or should become inoperative, the other terms shall
remain operative nonetheless. By mutual agreement, inoperative terms are to be replaced by such provisions which come as close as possible
to a successful commercial outcome. The same shall apply mutatis mutandis with regard to the filling of any loopholes.
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[Signature page to follow]
/s/ Jason Loveridge
4SC AG,
represented by Jason Loveridge
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/s/ Hella Kohlhof
Immunic AG,
represented by Hella Kohlhof
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/s/ Daniel Vitt
Immunic Inc,
represented by Daniel Vitt
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Immunic and 4SC AG Sign Agreement Regarding
the Settlement of Royalty Obligations for Immunic’s Lead Program, IMU-838
NEW YORK
and PLANEGG-MARTINSRIED, Germany, March 31, 2021 – Immunic, Inc. (Nasdaq: IMUX), a clinical-stage biopharmaceutical
company developing a pipeline of selective oral immunology therapies aimed at treating chronic inflammatory and autoimmune diseases, and
4SC AG (FSE Prime Standard: VSC), today announced the signing of an agreement under which Immunic will settle its remaining obligation
of a 4.4% royalty on net sales of selective oral DHODH inhibitor, IMU-838, for $17.25 million. The transaction will be payable 50% in
cash and 50% in shares of Immunic’s common stock.
Immunic acquired lead program IMU-838 in September
2016 from 4SC AG through an asset acquisition, in exchange for a one-time upfront cash payment, future milestone payments and a royalty
on net sales for a certain period. With completion of this transaction, no further payment obligations remain between Immunic and 4SC.
“Execution of this agreement with 4SC is
key, as it provides us with 100% of the future sales potential of our lead asset, IMU-838,” stated Daniel Vitt, Ph.D., Chief Executive
Officer and President of Immunic. “Backed by exceptionally strong data generated by our phase 2 EMPhASIS trial in relapsing-remitting
multiple sclerosis (RRMS), we are now planning to initiate a phase 3 trial during the second half of this year. We are excited to move
our pipeline forward and the acquisition of the royalties will enable us to realize the full market potential of IMU-838, not only as
a treatment for RRMS but also as a potential new therapeutic option for ulcerative colitis, Crohn’s disease, COVID-19, and primary
sclerosing cholangitis, thereby driving significant future value for our shareholders.”
Jason Loveridge, Ph.D., Chief Executive Officer
of 4SC, added, “4SC is very pleased to conclude this transaction as it provides non-dilutive financing for our own oncology programs,
extending our cash reach well into the second half of 2022. We are expecting exciting data from some key domatinostat programs, such as
DONIMI in the neoadjuvant space, in 2021 and this transaction will help us move this and other key studies in Merkel cell carcinoma forward.”
About Immunic,
Inc.
Immunic, Inc.
(Nasdaq: IMUX) is a clinical-stage biopharmaceutical company with a pipeline of selective oral immunology therapies aimed at treating
chronic inflammatory and autoimmune diseases. The company is developing three small molecule products: its lead development program, 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, ulcerative colitis, Crohn’s
disease, COVID-19, and primary sclerosing cholangitis. IMU-935, a selective inverse agonist of the transcription factor RORγt, is
targeted for development in psoriasis and Guillain-Barré syndrome. IMU-856, which targets the restoration of the intestinal barrier
function, is targeted for development in diseases involving bowel barrier dysfunction. For further information, please visit: www.imux.com.
About 4SC
4SC
AG is a clinical-stage biopharmaceutical company developing small-molecule drugs that can target key indications in cancer with
high unmet medical needs. 4SC’s pipeline is protected by a comprehensive portfolio of patents and currently comprises two drug candidates
in clinical development: resminostat and domatinostat.
4SC aims to generate
future growth and enhance its enterprise value by entering into partnerships with pharmaceutical and biotech companies and/or the eventual
marketing and sales of approved drugs in select territories by 4SC itself.
4SC is headquartered
in Planegg-Martinsried near Munich, Germany. The Company had 48 employees as of 31 December 2020 and is listed on the Prime Standard of
the Frankfurt Stock Exchange (FSE Prime Standard: VSC; ISIN: DE000A14KL72).
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, 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-838 to safely and effectively target diseases; clinical data for IMU-838; the timing
of current and future clinical trials; the nature, strategy and focus of the company; and the development and commercial potential of
IMU-838 and other 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 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, 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 resources to meet business objectives
and operational requirements, the fact that the results of earlier studies and 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, 2020, filed with the SEC on February 26, 2021, 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
Immunic, Inc. US IR Contact
Rx Communications Group
Paula Schwartz
+1 917 322 2216
immunic@rxir.com
Immunic, Inc. US Media Contact
KOGS Communication
Edna Kaplan
+1 781 639 1910
kaplan@kogspr.com
4SC AG
+49 89 700763 0
ir-pr@4sc.com
