UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 6-K
REPORT OF FOREIGN
PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER
THE SECURITIES EXCHANGE ACT OF 1934
January 22, 2024
Commission File Number: 001-39363
IMMATICS N.V.
Paul-Ehrlich-Straße 15
72076 Tübingen, Federal Republic of Germany
(Address of principal executive office)
Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F:
| Form 20-F |
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Form 40-F |
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INFORMATION CONTAINED IN THIS REPORT ON FORM 6-K
On January 22, 2024, Immatics N.V. (the “Company”) completed an offering of 18,313,750 ordinary shares (the “securities”), pursuant to an underwriting agreement (the “Underwriting Agreement”) with Jefferies LLC, Jefferies GmbH, BofA Securities, Inc. and Leerink Partners LLC, as representatives of the several underwriters. The Underwriting Agreement includes the terms and conditions for the offering and sale of the securities, indemnification and contribution obligations, and other terms and conditions customary in agreements of this type. The foregoing description of the Underwriting Agreement does not purport to be complete and is qualified in its entirety by reference to the Underwriting Agreement, which is attached to this Report on Form 6-K as Exhibit 1.1.
The offer and sale of the securities have been registered under the Securities Act of 1933, as amended, pursuant to a registration statement on Form F-3 (File No. 333-258351) (the “Registration Statement”). The Company has filed with the U.S. Securities and Exchange Commission a prospectus supplement dated January 17, 2024, together with an accompanying prospectus dated August 9, 2021, relating to the offer and sale of the securities. Opinion of counsel regarding the validity of the securities is attached to this Report on Form 6-K as Exhibit 5.1 and the consent of such counsel relating to the incorporation of such opinion into the Registration Statement is attached to this Report on Form 6-K as Exhibit 23.1.
The proceeds from the offer and sale of the securities is approximately $188.4 million, after deducting the underwriting discount and fees and offering expenses payable by the Company. The Company intends to use the net proceeds from the offer and sale of the securities to fund research and development activities and for working capital and other general corporate purposes.
INCORPORATION BY REFERENCE
This Report on Form 6-K (other than Exhibits 99.1, 99.2 and 99.3), including Exhibits 1.1, 5.1 and 23.1, shall be deemed to be incorporated by reference into the registration statement on Form F-3 (Registration No. 333-258351) of Immatics N.V. and to be a part thereof from the date on which this report is filed, to the extent not superseded by documents or reports subsequently filed or furnished.
This Report on Form 6-K (other than Exhibits 1.1, 5.1, 23.1, 99.1, 99.2 and 99.3) shall be deemed to be incorporated by reference into the registration statements on Form F-3 (Registration Nos. 333-240260 and 333-274218) of Immatics N.V. and to be a part thereof from the date on which this report is filed, to the extent not superseded by documents or reports subsequently filed or furnished.
EXHIBIT INDEX
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, thereunto duly authorized.
| IMMATICS N.V. | ||
| Date: January 22, 2024 | ||
| By: | /s/ Harpreet Singh | |
| Name: | Harpreet Singh | |
| Title: | Chief Executive Officer | |
Exhibit 1.1
Immatics N.V.
Ordinary Shares
(Nominal value €0.01 per share)
Underwriting Agreement
January 17, 2024
Jefferies LLC
Jefferies GmbH
BofA Securities, Inc.
Leerink Partners LLC
As representatives (the “Representatives”) of the several Underwriters
named in Schedule I hereto,
c/o Jefferies LLC
520 Madison Avenue
New York, NY 10022
c/o Jefferies GmbH
Bockenheimer Landstr. 24
60323 Frankfurt am Main
c/o BofA Securities, Inc.
One Bryant Park
New York, NY 10036
c/o Leerink Partners LLC
1301 Avenue of the Americas, 12th Floor
New York, NY 10019
Ladies and Gentlemen:
Immatics N.V., a public limited company (naamloze vennootschap) under Dutch law (the “Company”), proposes, subject to the terms and conditions stated in this agreement (this “Agreement”), to issue and sell to the Underwriters named in Schedule I hereto (the “Underwriters”) an aggregate of 15,925,000 (the “Firm Shares”) of the Company’s ordinary shares, nominal value €0.01 per share (“Ordinary Shares”), and, at the election of the Underwriters, up to 2,388,750 additional Ordinary Shares (the “Optional Shares”). The Firm Shares and the Optional Shares that the Underwriters elect to purchase pursuant to Section 2 hereof are collectively referred to as the “Shares.”
1. The Company represents and warrants to, and agrees with, each of the Underwriters that:
(a) A registration statement on Form F-3 (File No. 333-258351) (the “Registration Statement”) in respect of the Shares has been filed with the Securities and Exchange Commission (the “Commission”); the Registration Statement and any post-effective amendment thereto have been declared effective by the Commission and no stop order suspending the effectiveness of the Registration Statement or any post-effective amendment thereto or any part thereof has been issued and no proceeding for that purpose or pursuant to Section 8A of the Securities Act of 1933, as amended (the “Act”) has been initiated or, to the Company’s knowledge, threatened by the Commission (the base prospectus filed as part of the Initial Registration Statement, in the form in which it has most recently been filed with the Commission on or prior to the date of this Agreement relating to the Shares, is hereinafter called the “Basic Prospectus”; any preliminary prospectus (including any preliminary prospectus supplement) relating to the Shares filed with the Commission pursuant to Rule 424(b) under the Act is hereinafter called a “Preliminary Prospectus”; the various parts of the Registration Statement, including all exhibits thereto and including any prospectus supplement relating to the Shares that is filed with the Commission and deemed by virtue of Rule 430B under the Act to be part of the Registration Statement, each as amended at the time such part of the Registration Statement became effective are hereinafter collectively called the “Registration Statement”; the Basic Prospectus, as amended and supplemented immediately prior to the Applicable Time (as defined in Section 1(c) hereof), is hereinafter called the “Pricing Prospectus”; the form of the final prospectus relating to the Shares filed with the Commission pursuant to Rule 424(b) under the Act in accordance with Section 5(a) hereof is hereinafter called the “Prospectus”; any reference herein to the Basic Prospectus, the Pricing Prospectus, any Preliminary Prospectus or the Prospectus shall be deemed to refer to and include the documents incorporated by reference therein pursuant to Item 6 of Form F-3, as of the date of such prospectus; any reference to any amendment or supplement to the Basic Prospectus, any Preliminary Prospectus or the Prospectus shall be deemed to refer to and include any post-effective amendment to the Registration Statement, any prospectus supplement relating to the Shares filed with the Commission pursuant to Rule 424(b) under the Act and any documents filed under the Securities Exchange Act of 1934, as amended (the “Exchange Act”), and incorporated therein, in each case after the date of the Basic Prospectus, such Preliminary Prospectus or the Prospectus, as the case may be; any reference to any amendment to the Registration Statement shall be deemed to refer to and include any annual report of the Company filed pursuant to Section 13(a) or 15(d) of the Exchange Act after the effective date of the Registration Statement that is incorporated by reference in the Registration Statement; any oral or written communication with potential investors undertaken in reliance on Section 5(d) of the Act or Rule 163B under the Act is hereinafter called a “Testing-the-Waters Communication”; and any Testing-the-Waters Communication that is a written communication within the meaning of Rule 405 under the Act is hereinafter called a “Written Testing-the-Waters Communication”; and any “issuer free writing prospectus” as defined in Rule 433 under the Act relating to the Shares is hereinafter called an “Issuer Free Writing Prospectus”);
(b) (A) No order preventing or suspending the use of any Preliminary Prospectus or any Issuer Free Writing Prospectus has been issued by the Commission, and (B) each Preliminary Prospectus, at the time of filing thereof, conformed in all material respects to the requirements of the Act and the rules and regulations of the Commission thereunder, and did not contain an untrue statement of a material fact or omit to state a material fact required to be stated therein or necessary to make the statements therein, in the light of the circumstances under which they were made, not misleading; provided, however, that this representation and warranty shall not apply to any statements or omissions made in reliance upon and in conformity with the Underwriter Information (as defined in Section 9(b) hereof);
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(c) For the purposes of this Agreement, the “Applicable Time” is 7:55 p.m. (Eastern time) on the date of this Agreement. The Pricing Prospectus, as supplemented by the information listed on Schedule II(c) hereto, taken together (collectively, the “Pricing Disclosure Package”), as of the Applicable Time did not, and as of each Time of Delivery (as defined in Section 4(a) hereof) will not, include any untrue statement of a material fact or omit to state any material fact necessary in order to make the statements therein, in the light of the circumstances under which they were made, not misleading; and each Issuer Free Writing Prospectus and each Written Testing-the-Waters Communication does not conflict with the information contained in the Registration Statement, the Pricing Prospectus or the Prospectus and each Issuer Free Writing Prospectus and each Written Testing-the-Waters Communication, as supplemented by and taken together with the Pricing Disclosure Package as of the Applicable Time, did not, and as of each Time of Delivery will not, include any untrue statement of a material fact or omit to state any material fact necessary in order to make the statements therein, in the light of the circumstances under which they were made, not misleading; provided, however, that this representation and warranty shall not apply to statements or omissions made in reliance upon and in conformity with the Underwriter Information;
(d) The documents incorporated by reference in the Pricing Prospectus and Prospectus, when they became effective or were filed with the Commission, as the case may be, conformed in all material respects to the requirements of the Act or the Exchange Act, as applicable, and the rules and regulations of the Commission thereunder, and none of such documents contained an untrue statement of a material fact or omitted to state a material fact required to be stated therein or necessary to make the statements therein not misleading; and any further documents so filed and incorporated by reference in the Pricing Prospectus and the Prospectus or any further amendment or supplement thereto, when such documents become effective or are filed with the Commission, as the case may be, will conform in all material respects to the requirements of the Act or the Exchange Act, as applicable, and the rules and regulations of the Commission thereunder and will not contain an untrue statement of a material fact or omit to state a material fact required to be stated therein or necessary to make the statements therein not misleading; and no such or any other documents were filed with the Commission since the Commission’s close of business on the Business Day (as defined below) immediately prior to the date of this Agreement and prior to the execution of this Agreement, except as set forth on Schedule II(b) hereto;
(e) The Registration Statement conforms, as of its filing date, and the Prospectus and any further amendments or supplements to the Registration Statement and the Prospectus will conform, as of its filing date, in all material respects to the requirements of the Act and the rules and regulations of the Commission thereunder and do not and will not, as of the applicable effective date as to each part of the Registration Statement, as of the applicable filing date as to the Prospectus and any amendment or supplement thereto, and as of each Time of Delivery, contain an untrue statement of a material fact or omit to state a material fact required to be stated therein or necessary to make the statements therein not misleading; provided, however, that this representation and warranty shall not apply to any statements or omissions made in reliance upon and in conformity with the Underwriter Information;
(f) [Reserved];
(g) The interactive data in extensible Business Reporting Language included or incorporated by reference in the Registration Statement, the Pricing Prospectus and the Prospectus fairly presents the information called for in all material respects and has been prepared in accordance with the Commission’s rules and guidelines applicable thereto;
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(h) The Company is subject to and in compliance in all material respects with the reporting requirements of Section 13 or Section 15(d) of the Exchange Act; the Ordinary Shares are registered pursuant to Section 12(b) of the Exchange Act and are listed on The Nasdaq Stock Market (the “Nasdaq”), and the Company has taken no action designed to, or reasonably likely to have the effect of, terminating the registration of the Ordinary Shares under the Exchange Act or delisting the Ordinary Shares from Nasdaq, nor has the Company received any notification that the Commission or Nasdaq is contemplating terminating such registration or listing; the Company is in compliance in all material respects with the current listing standards of Nasdaq; the Company has filed or will file a Notification of Listing of Additional Shares with Nasdaq with respect to the Shares;
(i) Neither the Company nor any of its subsidiaries is a party to any contract, agreement or understanding with any person (other than this Agreement) that would give rise to a valid claim against the Company or any of its subsidiaries or the Underwriters for a brokerage commission, finder’s fee or like payment in connection with the offering and sale of the Shares;
(j) The Company and each of its subsidiaries have been duly incorporated or organized (and are in good standing, to the extent such concept is applicable) under the laws of their respective jurisdictions of organization, are validly existing and are duly qualified to do business (and are in good standing, to the extent such concept is applicable), in each jurisdiction in which their respective ownership or lease of property or the conduct of their respective businesses requires such qualification, and have all power and authority necessary to own or hold their respective properties and to conduct the businesses as described in the Pricing Prospectus, except where the failure to be so qualified (or in good standing, to the extent such concept is applicable) or have such power or authority would not, individually or in the aggregate, reasonably be expected to have a Material Adverse Effect (as defined below); and the Company does not own or control, directly or indirectly, any corporation, association or other entity other than as disclosed in the Pricing Prospectus; as used in this Agreement, “Material Adverse Effect” shall mean a material adverse effect on the business, properties, management, financial position, shareholders’ equity, results of operations or prospects of the Company and its subsidiaries taken as a whole or on the performance by the Company of its obligations under this Agreement;
(k) All of the issued and outstanding share capital or other equity or ownership interests of each subsidiary has been duly authorized and validly issued, is fully paid and non-assessable, has been issued in compliance with federal state and securities laws and is owned by the Company, directly or through other wholly-owned subsidiaries, free and clear of any security interest, mortgage, pledge, lien, encumbrance or adverse claim; no subsidiary of the Company is prohibited or restricted, directly or indirectly, from paying dividends to the Company, from making any other distribution with respect to such subsidiary’s equity securities, from repaying to the Company or any other subsidiary any amounts that may from time to time become due under any loans or advances to such subsidiary from the Company or from transferring any property or assets to the Company or to any other subsidiary;
(l) The Company has an authorized capital as set forth in the Pricing Prospectus and all of the outstanding Ordinary Shares of the Company have been duly authorized and validly issued and are fully paid and non-assessable (meaning that a holder of any such Ordinary Shares shall not by reason of merely being such a holder be subject to assessment or calls by the Company or its creditors for further payment on such Ordinary Shares) and are not subject to any pre-emptive or similar rights that have not been duly waived or satisfied or validly excluded; except as described in or expressly contemplated by the Pricing Prospectus and the Prospectus, there are no outstanding rights (including, without limitation, pre-emptive rights), warrants or options to acquire, or
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instruments convertible into or exchangeable for, any Ordinary Shares or other equity interest in the Company or any of its subsidiaries, or any contract, commitment, agreement, understanding or arrangement of any kind relating to the issuance of any Ordinary Shares or other equity interest of the Company or any such subsidiary, any such convertible or exchangeable securities or any such rights, warrants or options; the Ordinary Shares of the Company conform in all material respects to the description thereof contained in the Pricing Disclosure Package and the Prospectus;
(m) With respect to the share options or performance shares (the “Share Options”) granted pursuant to the share-based compensation plans of the Company and its subsidiaries (the “Company Share Plans”), (i) each grant of a Share Option was duly authorized no later than the date on which the grant of such Share Option was by its terms to be effective by all necessary corporate action, including, as applicable, approval by the board of directors or similar governing body of the Company (or its designee) and any required shareholder approval by the necessary number of votes or written consents, and to the knowledge of the Company (other than with respect to the execution and delivery by the Company), the award agreement governing such grant (if any) was duly executed and delivered by each party thereto, (ii) each such grant was made in accordance with the terms of the applicable Company Share Plans, the Exchange Act and all other applicable laws and regulatory rules or requirements, including the rules of Nasdaq, applicable to the Company on the date the Share Option was granted and (iii) each such grant was properly accounted for in accordance with International Financial Reporting Standards as issued by the International Accounting Standards Board (“IFRS”) in the financial statements (including the related notes) of the Company;
(n) The Shares have been duly authorized by the Company and, when issued and delivered and paid for as provided herein, will be validly issued, fully paid and non-assessable (meaning that a holder of any such Shares shall not by reason of merely being such a holder be subject to assessment or calls by the Company or its creditors for further payment on such Shares) and will conform to the descriptions of the Ordinary Shares contained in the Pricing Prospectus and the Prospectus; neither the issuance nor the sale of the Shares is subject to any pre-emptive or similar rights the exercise and transfer of which have not been validly and irrevocably waived or otherwise validly and irrevocably declined or excluded; the Shares, when delivered against payment therefor, will be freely transferable to or for the account of the Underwriters and the initial purchasers thereof; there are no restrictions on subsequent transfers of the Shares under the laws of the Netherlands that generally restrict subsequent transfers of the Shares.
(o) Except as disclosed in the Registration Statement, the Pricing Prospectus and the Prospectus, neither the Company nor any of its subsidiaries has sent or received any written communication regarding the termination of, or non-renewal or non-performance under, any contract or agreement that is material to the Company and that is described in the Registration Statement, the Pricing Prospectus or the Prospectus, except such termination, non-renewal or non-performance that would not, individually or in the aggregate, reasonably be expected to have a Material Adverse Effect;
(p) This Agreement has been duly authorized, executed and delivered by the Company;
(q) The Company is not and, after giving effect to the offering and sale of the Shares and the application of the proceeds thereof as described in the Pricing Prospectus, will not be required to register as an “investment company” or an entity “controlled” by an “investment company” within the meaning of the Investment Company Act of 1940, as amended, and the rules and regulations of the Commission thereunder (collectively, the “Investment Company Act”);
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(r) No consent, approval, authorization, order, registration or qualification of or with any court or arbitrator or governmental or regulatory authority is required for the execution, delivery and performance by the Company of this Agreement, the issuance of the Shares, the sale of the Shares and the consummation of the transactions contemplated by this Agreement, except for such consents, approvals, authorizations, orders and registrations or qualifications as may be required by Nasdaq, the Financial Industry Regulatory Authority, Inc. (“FINRA”) and under applicable state securities laws in connection with the purchase and distribution of the Shares as contemplated hereunder;
(s) The execution, delivery and performance by the Company of this Agreement, the issuance of the Shares, the sale of the Shares, and the consummation of the transactions contemplated by this Agreement and the Pricing Prospectus will not (i) conflict with or result in a breach or violation of any of the terms or provisions of, or constitute a default under, result in the termination, modification or acceleration of, or result in the creation or imposition of any lien, charge or encumbrance upon any property, right or asset of the Company or any of its subsidiaries pursuant to, any indenture, mortgage, deed of trust, loan agreement or other agreement or instrument to which the Company or any of its subsidiaries is a party or by which the Company or any of its subsidiaries is bound or to which any property, right or asset of the Company or any of its subsidiaries is subject, (ii) result in any violation of the provisions of the articles of association or similar organizational documents of the Company or any of its subsidiaries or (iii) result in the violation of any law or statute or any judgment, order, rule or regulation of any court or arbitrator or governmental or regulatory authority, except, in the case of clauses (i) and (iii) above, for any such conflict, breach, violation, default, lien, charge or encumbrance that would not, individually or in the aggregate, reasonably be expected to have a Material Adverse Effect;
(t) Subsequent to the respective dates as of which information is given in the Registration Statement and the Pricing Prospectus, (i) there has not been any material change in the share capital (other than the sale of Shares hereunder and the issuance of Ordinary Shares upon exercise or settlement of options, awards or warrants described in, and the grant of options and awards under equity incentive plans described in, the Pricing Prospectus and the Prospectus), short-term debt or long-term debt of the Company or any of its subsidiaries, or any dividend or distribution of any kind declared, set aside for payment, paid or made by the Company on any class of share capital, or any material adverse change, or any development involving a prospective material adverse change, in or affecting the business, properties, management, financial position, shareholders’ equity, results of operations or prospects of the Company and its subsidiaries taken as a whole or the performance by the Company of its obligations under this Agreement; (ii) neither the Company nor any of its subsidiaries has entered into any transaction or agreement (whether or not in the ordinary course of business) that is material to the Company and its subsidiaries taken as a whole or incurred any liability or obligation, direct or contingent, that is material to the Company and its subsidiaries taken as a whole; and (iii) neither the Company nor any of its subsidiaries has sustained any loss or interference with its business that is material to the Company and its subsidiaries taken as a whole and that is either from fire, explosion, flood or other calamity, whether or not covered by insurance, or from any labor disturbance or dispute or any action, order or decree of any court or arbitrator or governmental or regulatory authority;
(u) No person has the right to require the Company or any of its subsidiaries to register any securities for sale under the Act by reason of the filing of the Registration Statement with the Commission or the sale of the Shares, except for such rights as have been satisfied or duly waived;
(v) The financial statements (including the related notes thereto) of the Company and its consolidated subsidiaries, which are included or incorporated by reference in the Registration
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Statement, the Pricing Prospectus and the Prospectus, comply in all material respects with the applicable requirements of the Act and the Exchange Act and present fairly in all material respects the financial position of the Company and its consolidated subsidiaries as of the dates indicated and the results of its operations and its changes in cash flows for the periods specified; the financial statements of the Company and its consolidated subsidiaries have been prepared in conformity with IFRS applied on a consistent basis throughout the periods covered thereby, except as may be expressly stated in the related notes thereto, and except in the case of unaudited financial statements, which are subject to normal year-end adjustments and do not contain certain footnotes as permitted by the applicable rules of the Commission, and any supporting schedules included or incorporated by reference in the Registration Statement, the Pricing Prospectus or the Prospectus present fairly in all material respects the information required to be stated therein; the other financial information included or incorporated by reference in the Registration Statement, the Pricing Prospectus and the Prospectus has been derived from the accounting records of the Company and its consolidated subsidiaries or of such other company and presents fairly in all material respects the information shown thereby;
(w) Except as described in the Pricing Prospectus, (i) there are no legal, governmental or regulatory investigations, actions, demands, claims, suits, arbitrations, inquiries or proceedings (“Actions”) pending to which the Company or any of its subsidiaries is a party or to which any property of the Company or any of its subsidiaries is subject that would, individually or in the aggregate, if determined adversely to the Company or any of its subsidiaries, reasonably be expected to have a Material Adverse Effect and (ii) to the knowledge of the Company, no Actions are threatened or contemplated by any governmental or regulatory authority or threatened by others; there are no current or pending Actions that are required under the Act to be described in the Registration Statement or the Pricing Prospectus that are not so described therein;
(x) The Company and its subsidiaries have good and marketable title in fee simple (in the case of real property) to, or have valid rights to lease or otherwise use, all items of real and personal property that are material to the respective businesses of the Company and its subsidiaries, taken as a whole, in each case free and clear of all liens, encumbrances, claims and defects and imperfections of title except those that (i) do not materially interfere with the use made and proposed to be made of such property by the Company and its subsidiaries or (ii) would not reasonably be expected, individually or in the aggregate, to have a Material Adverse Effect;
(y) Neither the Company nor any of its subsidiaries is (i) in violation of its articles of association or similar organizational documents, (ii) in violation of any law or statute or any judgment, order, rule or regulation of any court or arbitrator or governmental or regulatory authority, or (iii) in default, and no event has occurred that, with notice or lapse of time or both would constitute such default, in the due performance or observance of any term, covenant or condition contained in any indenture, mortgage, deed of trust, loan agreement or other agreement or instrument to which the Company or any of its subsidiaries is a party or by which the Company or any of its subsidiaries is bound or to which any property or assets of the Company or any of its subsidiaries is subject, except, in the case of clauses (ii) and (iii) above, for any such default or violation as would not, individually or in the aggregate, reasonably be expected to have a Material Adverse Effect;
(z) PricewaterhouseCoopers GmbH Wirtschaftsprüfungsgesellschaft, whose audit opinion covers the financial statements of the Company and its subsidiaries that are included or incorporated by reference in the Registration Statement and the Prospectus, is an independent registered public accounting firm with respect to the Company and its subsidiaries within the applicable rules and regulations adopted by the Commission and the Public Company Accounting
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Oversight Board (United States) and as required by the Act and the rules and regulations of the Commission thereunder;
(aa) Except as disclosed in each of the Registration Statement, the Pricing Prospectus and the Prospectus, and except for any net income, capital gains or franchise taxes imposed on the Underwriters by the governments of the Netherlands, the United States, or any political subdivision or taxing authority thereof or therein as a result of any present or former connection between the Underwriters and the jurisdiction imposing such tax, no stamp duties or other issuance or transfer taxes (for the avoidance of doubt this does not include any value added tax or similar taxes) are payable by or on behalf of the Underwriters in the Netherlands, the United States or any political subdivision or tax authority thereof solely in connection with (i) the execution, delivery and performance of this Agreement; or (ii) the issuance, sale and delivery of the Shares as contemplated herein and in the Pricing Disclosure Package;
(bb) The Company and its subsidiaries have paid all federal, state, local and foreign taxes and filed all tax returns required to be paid or filed through the date that this representation is made, except as may be being contested in good faith and by appropriate proceedings, or where the failure to pay or file such taxes or tax returns would not reasonably be expected to have a Material Adverse Effect; except as disclosed in each of the Registration Statement, the Pricing Prospectus and the Prospectus, there is no tax deficiency that has been, or would reasonably be expected to be, asserted against the Company or any of its subsidiaries or any of their respective properties or assets that has or would reasonably be expected to have a Material Adverse Effect, except for any tax deficiency being contested in good faith and for which appropriate reserves have been provided in accordance with IFRS;
(cc) No labor disturbance by or dispute with employees of the Company or any of its subsidiaries exists or, to the knowledge of the Company, is contemplated or threatened, and the Company is not aware of any existing or imminent labor disturbance by, or dispute with, the employees of any of its or its subsidiaries’ principal suppliers, contractors or customers, except as would not reasonably be expected to have a Material Adverse Effect; neither the Company nor any of its subsidiaries has received any written notice of cancellation or termination with respect to any collective bargaining agreement that is material to the Company to which it is a party;
(dd) The Company and its subsidiaries have insurance covering their respective properties, operations, personnel and businesses, including business interruption insurance, which insurance is in such amounts and insures against such losses and risks as are generally maintained by similarly situated companies and which the Company believes are adequate to protect the Company and its subsidiaries and their respective businesses; neither the Company nor any of its subsidiaries has (i) received written notice from any insurer or agent of such insurer that capital improvements or other expenditures are required or necessary to be made in order to continue such insurance or (ii) any reason to believe that it will not be able to renew its existing insurance coverage as and when such coverage expires or to obtain comparable coverage from similar insurers as may be necessary to continue its business as now conducted at a cost that would not reasonably be expected to have a Material Adverse Effect;
(ee) The Company and its subsidiaries possess all licenses, sub-licenses, certificates, permits and other authorizations issued by, and have made all declarations and filings with, the appropriate federal, state, local or foreign governmental or regulatory authorities that are necessary for the ownership or lease of their respective properties or the conduct of their respective businesses as described in each of the Registration Statement, the Pricing Prospectus and the Prospectus, except where the failure to possess or make the same would not, individually or in the aggregate,
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reasonably be expected to have a Material Adverse Effect; except as described in each of the Registration Statement, the Pricing Prospectus and the Prospectus, neither the Company nor any of its subsidiaries has received written notice of any revocation or modification of any such license, sub-license, certificate, permit or authorization or has any reason to believe that any such license, sub-license, certificate, permit or authorization will not be renewed in the ordinary course, except where such revocation or modification would not reasonably be expected to have a Material Adverse Effect;
(ff) The Company and its subsidiaries maintain systems of “internal control over financial reporting” (as defined in Rule 13a-15(f) under the Exchange Act) that comply in all material respects with the requirements of the Exchange Act and have been designed by, or under the supervision of, their respective principal executive and principal financial officers, or persons performing similar functions, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with IFRS; the Company and its subsidiaries maintain internal accounting controls that are designed to be sufficient to provide reasonable assurance that (i) transactions are executed in accordance with management’s general or specific authorizations; (ii) transactions are recorded as necessary to permit preparation of financial statements in conformity with IFRS and to maintain asset accountability; (iii) access to assets is permitted only in accordance with management’s general or specific authorization; and (iv) the recorded accountability for assets is compared with the existing assets at reasonable intervals and appropriate action is taken with respect to any differences; except as disclosed in the Pricing Prospectus, there are no material weaknesses in the Company’s internal controls; the Company’s auditors and the Audit Committee of the board of directors of the Company have been advised of: (x) all significant deficiencies and material weaknesses in the design or operation of internal controls over financial reporting which have adversely affected or are reasonably likely to adversely affect the Company’s ability to record, process, summarize and report financial information; and (y) any fraud, whether or not material, that involves management or other employees who have a significant role in the Company’s internal controls over financial reporting;
(gg) The Company maintains an effective system of “disclosure controls and procedures” (as defined in Rule 13a-15(e) under the Exchange Act) that complies in all material respects with the requirements of the Exchange Act and that has been designed to ensure that information required to be disclosed by the Company in reports that it files or submits under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in the Commission’s rules and forms, including controls and procedures designed to ensure that such information is accumulated and communicated to the Company’s management as appropriate to allow timely decisions regarding required disclosure; the Company has carried out an evaluation of its effectiveness of its disclosure controls and procedures to the extent required by Rule 13a-15 of the Exchange Act;
(hh) Except any such matter as would not, individually or in the aggregate, reasonably be expected to have a Material Adverse Effect, (i) the Company and its subsidiaries (1) are in compliance with all applicable federal, state, local and foreign laws (including common law), rules, regulations, requirements, decisions, judgments, decrees, orders and other legally enforceable requirements relating to pollution or the protection of human health or safety, the environment, natural resources, hazardous or toxic substances or wastes, pollutants or contaminants (collectively, “Environmental Laws”); (2) have received and are in compliance with all permits, licenses, certificates or other authorizations or approvals required of them under any Environmental Laws to conduct their respective businesses; and (3) have not received written notice of any actual or potential liability or obligation under or relating to, or any actual or potential violation of, any
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Environmental Laws, including for the investigation or remediation of any disposal or release of hazardous or toxic substances or wastes, pollutants or contaminants, and have no knowledge of any event or condition that would reasonably be expected to result in any such notice, and (ii) there are no costs or liabilities associated with Environmental Laws of or relating to the Company or its subsidiaries; except as described in the Registration Statement, the Pricing Prospectus and the Prospectus, (x) there is no proceeding that is pending, or that is known to be contemplated, against the Company or any of its subsidiaries under any Environmental Laws in which a governmental entity is also a party, other than such proceeding regarding which it is reasonably believed no monetary sanctions of $100,000 or more will be imposed, (y) the Company and its subsidiaries are not aware of any facts or issues regarding compliance with Environmental Laws, or liabilities or other obligations under Environmental Laws or concerning hazardous or toxic substances or wastes, pollutants or contaminants, that would reasonably be expected to have a Material Adverse Effect, and (z) none of the Company or its subsidiaries anticipates material capital expenditures relating to any Environmental Laws;
(ii) Except as disclosed in the Registration Statement, the Pricing Prospectus and the Prospectus, neither the Company nor any of its ERISA Affiliates (as defined hereafter) has any liability (contingent or otherwise) under the Employee Retirement Income Security Act of 1974, as amended (“ERISA”) with respect to any “employee benefit plan”, as defined in Section 3(3) of ERISA; as used in this Agreement, an “ERISA Affiliate” of any person or entity shall mean any other person or entity which, together with that person or entity, could be treated as a single employer under Section 414(b), (c), (m) or (o) of the Internal Revenue Code of 1986 (the “Code”); each “employee benefit plan”, as defined in Section 3(3) of ERISA that is maintained for the benefit of the employees of the Company or its affiliates has been maintained in material compliance with its terms and the requirements of applicable law; the Registration Statement, the Pricing Prospectus and the Prospectus identify each employment, severance or other similar agreement, arrangement or policy and each material plan or arrangement required to be disclosed pursuant to the Act providing for insurance coverage (including any self-insured arrangements), workers’ compensation, disability benefits, severance benefits, supplemental unemployment benefits, vacation benefits or retirement benefits, or deferred compensation, profit-sharing, bonuses, share options, share appreciation rights or other forms of incentive compensation, or post-retirement insurance, compensation or benefits that is entered into, maintained or contributed to, as the case may be, by the Company or any of its affiliates for the benefit of any officer, executive director or non-executive director or former officer or director of the Company or any of its affiliates; these agreements, arrangements, policies or plans are referred to collectively as “Benefit Arrangements”; except as disclosed in the Registration Statement, the Pricing Prospectus and the Prospectus, each Benefit Arrangement has been maintained in material compliance with its terms and with the requirements of applicable law and there is no liability in respect of post-retirement health and medical benefits for retired employees of the Company or any of its affiliates, other than medical benefits required to be continued under applicable law;
(jj) There is and has been no failure on the part of the Company or any of the Company’s executive directors, non-executive directors or officers, in their capacities as such, to comply with any provision of the Sarbanes-Oxley Act of 2002, as amended and the rules and regulations promulgated in connection therewith applicable to the Company as of the date the Company became subject to such provisions, including Section 402 related to loans;
(kk) Neither the Company nor any of its subsidiaries nor any officer, executive director or non-executive director of the Company or its subsidiaries nor, to the knowledge of the Company, any employee of, any agent, affiliate or other person associated with or acting on behalf of, the Company or any of its subsidiaries has (i) made, offered, promised or authorized any unlawful
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contribution, gift, entertainment or other unlawful expense (or taken any act in furtherance thereof); (ii) made or taken an act in furtherance of an offer, promise or authorization of any direct or indirect unlawful payment or benefit to any foreign or domestic government official or employee, including of any government-owned or controlled entity or of a public international organization, or any person acting in an official capacity for or on behalf of any of the foregoing, or any political party or party official or candidate for political office; (iii) violated or is in violation of any provision of the Foreign Corrupt Practices Act of 1977, as amended, or the rules and regulations thereunder, any applicable law or regulation implementing the OECD Convention on Combating Bribery of Foreign Public Officials in International Business Transactions or the Bribery Act 2010 of the United Kingdom or any other applicable anti-bribery, anti-corruption or related law, statute or regulation (collectively, “Anti-Corruption Laws”); or (iv) made, offered, promised, authorized, agreed, requested or taken an act in furtherance of any unlawful bribe or other unlawful benefit, including, without limitation, any rebate, payoff, influence payment, kickback or other direct or indirect unlawful or improper payment or benefit; the Company and its subsidiaries have conducted their businesses in compliance with all Anti-Corruption Laws and each have instituted and maintained, and will continue to maintain and enforce, policies and procedures reasonably designed to promote and ensure compliance with all Anti-Corruption Laws and with the representations and warranties contained in this paragraph; neither the Company nor any of its subsidiaries will use, directly or indirectly, the proceeds of the offering of Shares hereunder in furtherance of an offer, payment, promise to pay, or authorization of the payment or giving of money, or anything else of value, to any person in violation of Anti-Corruption Laws;
(ll) The operations of the Company and its subsidiaries are and have been conducted at all times in compliance with applicable financial recordkeeping and reporting requirements, including those of the Currency and Foreign Transactions Reporting Act of 1970, as amended, the applicable money laundering statutes of all jurisdictions where the Company or any of its subsidiaries conducts business, the rules and regulations thereunder and any related or similar rules, regulations or guidelines issued, administered or enforced by any governmental agency (collectively, the “Anti-Money Laundering Laws”) and no action, suit or proceeding by or before any court or governmental agency, authority or body or any arbitrator involving the Company or any of its subsidiaries with respect to the Anti-Money Laundering Laws is pending or, to the knowledge of the Company, threatened;
(mm) Neither the Company nor any of its subsidiaries nor any executive director, non-executive director or officer of the Company or its subsidiaries nor, to the knowledge of the Company, any employee of, or any agent, affiliate or other person associated with or acting on behalf of, the Company or any of its subsidiaries is (i) currently the subject or the target of any sanctions administered or enforced by the U.S. government (including, without limitation, the Office of Foreign Assets Control of the U.S. Department of the Treasury or the U.S. Department of State and including, without limitation, the designation as a “specially designated national” or “blocked person”), the United Nations Security Council, the European Union, His Majesty’s Treasury or other relevant sanctions authority (collectively, “Sanctions”), (ii) located, organized or resident in a country or territory that is the subject or target of Sanctions, including, without limitation, the Crimea region of Ukraine, the so-called Donetsk People’s Republic, the so-called Luhansk People’s Republic, Cuba, Iran, North Korea and Syria (a “Sanctioned Country”); the Company will not directly or indirectly use the proceeds of the offering of the Shares hereunder, or lend, contribute or otherwise make available such proceeds to any subsidiary, joint venture partner or other person or entity (x) to fund or facilitate any activities of or business with any person that, at the time of such funding or facilitation, is the subject or target of Sanctions, (y) to fund or facilitate any activities of or business in any Sanctioned Country or (z) in any other manner that will result in a violation by any person (including any person participating in the transaction,
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whether as underwriter, advisor, investor or otherwise) of Sanctions; for the past five (5) years, the Company and its subsidiaries have not engaged in and are not now engaged in any dealings or transactions with or involving any person that is, or at the time of the dealing or transaction was, the subject or the target of Sanctions or with any Sanctioned Country; the Company and its subsidiaries have instituted, and maintain, policies and procedures designed to promote and achieve compliance with Sanctions; nothing in this paragraph shall impose any obligations and/or restrictions on the Company or any of its subsidiaries that will cause the Company or any of its subsidiaries to be, and will only apply if and to the extent that it does not cause the Company or any of its subsidiaries to be, in violation of EU Regulation (EC) 2271/96 (EU Blocking Statute) as amended from time to time, or any applicable implementing legislation, including but not limited to the German Foreign Trade Regulations (Außenwirtschaftsverordnung), or any similar anti-boycott law, statute or regulation;
(nn) Except as described in the Pricing Prospectus and the Prospectus, (i) the Company and its subsidiaries own or have a valid and enforceable right to use all patents, patent applications, trademarks, service marks, trade names, Internet domain name registrations (and all applications for, and all goodwill associated with, such trademarks, service marks, trade names and Internet domain name registrations), copyrights, copyright registrations, licenses and trade secret rights, in each case, in any jurisdiction throughout the world (collectively, “Intellectual Property Rights”) and inventions, know-how, software, databases, systems, procedures, and other intellectual property (including trade secrets and proprietary or confidential information) (collectively, “Intellectual Property Assets”) used or held for use in any material respect, or otherwise necessary for, the conduct of their respective businesses as currently conducted and as proposed to be conducted as described in the Pricing Prospectus and the Prospectus; (ii) the Company’s and its subsidiaries’ conduct of their respective businesses does not infringe, misappropriate or otherwise violate, and has not infringed, misappropriated or otherwise violated, any Intellectual Property Rights or Intellectual Property Assets of any third party in any material respect (it being understood that the foregoing representation in this clause (ii) is made to the Company’s knowledge with respect to patents); (iii) the Company and its subsidiaries have not received notice of any pending or threatened action, suit, or proceeding by any third party that would reasonably be expected to have a Material Adverse Effect on the Company’s or any of its subsidiaries’ respective businesses as presently conducted and as proposed to be conducted as described in the Pricing Prospectus and the Prospectus, challenging the Company’s or any of its subsidiaries’ rights in or to any of the Intellectual Property Rights or Intellectual Property Assets owned by or licensed to the Company or any of its subsidiaries, challenging the validity, enforceability or scope of any of the Intellectual Property Rights owned by or licensed to the Company or any of its subsidiaries, or alleging that the Company or any of its subsidiaries has infringed, misappropriated or otherwise violated any Intellectual Property Rights or Intellectual Property Assets of any third party; (iv) to the knowledge of the Company, neither the Intellectual Property Rights nor the Intellectual Property Assets of the Company and its subsidiaries and neither the Intellectual Property Rights nor the Intellectual Property Assets exclusively licensed to the Company and its subsidiaries are being materially infringed, misappropriated or otherwise violated by any third party; (v) other than as would not reasonably be expected to have a Material Adverse Effect, all Intellectual Property Rights and Intellectual Property Assets owned by the Company or any of its subsidiaries are solely and exclusively owned by the Company or such subsidiaries and all other Intellectual Property Rights and Intellectual Property Assets used or held for use by the Company or any of its subsidiaries are licensed to the Company or such subsidiaries, and the Company and its subsidiaries hold all of such ownership and license rights, in each case, free and clear of all liens, encumbrances, defects or other restrictions; (vi) other than as would not reasonably be expected to have a Material Adverse Effect, the Company and its subsidiaries are not aware of any facts that could result in a finding that any of the Intellectual Property Rights owned by or licensed to the Company are invalid or
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unenforceable; (vii) other than as would not reasonably be expected to have a Material Adverse Effect, the Company and its subsidiaries have taken reasonable steps in accordance with customary industry practice to maintain and protect any confidential information and trade secrets of the Company and its subsidiaries and to protect any confidential information provided to them by any third party; (viii) other than as would not reasonably be expected to have a Material Adverse Effect, the Company and its subsidiaries have taken commercially reasonable actions to maintain and to protect all patents and trademark and copyright and Internet domain name registrations (including all applications therefor) owned by the Company or any of its subsidiaries, including payment of applicable maintenance fees, filing of applicable statements of use, timely response office actions, and disclosure of any required information; (ix) other than as would not reasonably be expected to have a Material Adverse Effect, all personnel (including founders, current and former employees, consultants, contractors, representatives, and agents) involved in the development of Intellectual Property Rights or Intellectual Property Assets for or on behalf of the Company or any of its subsidiaries have signed written and enforceable confidentiality and invention assignment agreements with the Company or any of its subsidiaries pursuant to which the Company or any of its subsidiaries either (A) has obtained sole and exclusive ownership of such Intellectual Property Rights or Intellectual Property Assets, or (B) has obtained a valid right to exploit such Intellectual Property Rights or Intellectual Property Assets, sufficient for the conduct of the business as currently conducted and as proposed to be conducted as described in the Pricing Prospectus and the Prospectus; (x) to the Company’s knowledge, the Company and its subsidiaries have complied with the terms of each agreement pursuant to which Intellectual Property Rights or Intellectual Property Assets have been licensed to the Company and its subsidiaries; and (xi) the parties prosecuting such applications have complied with their duty of candor and disclosure to the United States Patent and Trademark Office (“USPTO”) in connection with such applications, and the Company is not aware of any facts required to be disclosed to the USPTO that were not disclosed to the USPTO and which would preclude the grant of a patent in connection with any such application or could form the basis of a finding of invalidity with respect to any patents that have issued with respect to such applications;
(oo) Except as described in the Registration Statement, the Pricing Prospectus and the Prospectus, the Company (collectively with its subsidiaries): (i) has operated and currently operates its business in compliance in all material respects with applicable provisions of the Health Care Laws (as defined below) of the Food and Drug Administration (“FDA”), the Department of Health and Human Services and any comparable foreign or other regulatory authority to which they are subject (collectively, the “Applicable Regulatory Authorities”) applicable to the ownership, testing, development, manufacture, packaging, processing, use, distribution, storage, import, export or disposal of any of the Company’s or its subsidiaries’ product candidates or any product manufactured or distributed by the Company; (ii) has not received any FDA Form 483, written notice of adverse finding, warning letter, untitled letter or other correspondence or written notice from any court or arbitrator or governmental or regulatory authority alleging or asserting non-compliance with (A) any Health Care Laws or (B) any licenses, certificates, approvals, clearances, exemptions, authorizations, permits and supplements or amendments thereto required by any such Health Care Laws (“Regulatory Authorizations”); (iii) possesses all Regulatory Authorizations required to conduct its business as currently conducted, except where the failure to possess the same would not, individually or in the aggregate, have a Material Adverse Effect, and such Regulatory Authorizations are valid and in full force and effect and the Company is not in violation, in any material respect, of any term of any such Regulatory Authorizations; (iv) has not received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from the Applicable Regulatory Authorities or any other third party alleging that any product of the Company is in material violation of any Health Care Laws or Regulatory Authorizations and has no knowledge that the Applicable Regulatory Authorities or any other third
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party is considering any such claim, litigation, arbitration, action, suit, investigation or proceeding; (v) has not received written notice that any of the Applicable Regulatory Authorities has taken, is taking or intends to take action to limit, suspend, modify or revoke any material Regulatory Authorizations and has no knowledge that any of the Applicable Regulatory Authorities is considering such action; (vi) has filed, obtained, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Health Care Laws or Regulatory Authorizations and that all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were materially complete and correct on the date filed (or were materially corrected or supplemented by a subsequent submission); (vii) is not a party to and does not have any ongoing reporting obligations pursuant to any corporate integrity agreements, deferred prosecution agreements, monitoring agreements, consent decrees, settlement orders, plans of correction or similar agreements with or imposed by any Applicable Regulatory Authority; and (viii) along with its employees, officers, executive directors and non-executive directors, has not been excluded, suspended or debarred from participation in any government health care program or human clinical research and, to the knowledge of the Company, is not subject to a governmental inquiry, investigation, proceeding, or other similar action that would reasonably be expected to result in debarment, suspension, or exclusion; as used in this Agreement, the term “Health Care Laws” shall mean Title XVIII of the Social Security Act, 42 U.S.C. §§ 1395-1395hhh (the Medicare statute); Title XIX of the Social Security Act, 42 U.S.C. §§ 1396-1396v (the Medicaid statute); the Federal Anti-Kickback Statute, 42 U.S.C. § 1320a-7b(b); the civil False Claims Act, 31 U.S.C. §§ 3729 et seq.; the criminal False Claims Act, 42 U.S.C. 1320a-7b(a); any criminal laws relating to health care fraud and abuse, including but not limited to 18 U.S.C. Sections 286 and 287; the Civil Monetary Penalties Law, 42 U.S.C. §§ 1320a-7a and 1320a-7b; the Physician Payments Sunshine Act, 42 U.S.C. § 1320a-7h; the Exclusion Statute, 42 U.S.C. § 1320a-7; the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. §§ 301 et seq.; the Public Health Service Act, 42 U.S.C. §§ 201 et seq.; the regulations promulgated pursuant to such laws; and any similar federal, state and local laws and regulations;
(pp) Except as described in the Registration Statement, the Pricing Prospectus and the Prospectus, the pre-clinical studies and clinical trials conducted by or, to the knowledge of the Company, on behalf of or sponsored by the Company, or in which the Company has participated that are described in the Registration Statement, the Pricing Prospectus or the Prospectus or the results of which are referred to in the Registration Statement, the Pricing Prospectus or the Prospectus, as applicable, were, and if still pending are, being conducted in all material respects in accordance with standard medical and scientific research standards and procedures for products or product candidates comparable to those being developed by the Company and all applicable statutes and all applicable rules and regulations of the Applicable Regulatory Authorities and current Good Clinical Practices and Good Laboratory Practices; the descriptions in the Registration Statement, the Pricing Prospectus and the Prospectus of the results of such studies and trials are, to the knowledge of the Company, accurate and complete in all material respects and fairly present the data derived therefrom; the Company has no knowledge of any other studies or trials not described in the Registration Statement, the Pricing Prospectus and the Prospectus the results of which are inconsistent with or which the Company reasonably believes call into question the results described or referred to in the Registration Statement, the Pricing Prospectus and the Prospectus; the Company has not received any written notices or correspondence from the Applicable Regulatory Authorities or any other governmental agency requiring or threatening the termination, modification or suspension of any pre-clinical studies or clinical trials that are described in the Registration Statement, the Pricing Prospectus and the Prospectus or the results of which are referred to in the Registration Statement, the Pricing Prospectus or the Prospectus other than ordinary course communications with respect to modifications in connection with the design and
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implementation of such studies or trials, and, to the Company’s knowledge, there are no reasonable grounds for the same;
(qq) The Company is not required to register as a “broker” or “dealer” in accordance with the provisions of the Exchange Act and does not, directly or indirectly through one or more intermediaries, control or have any other association with (within the meaning of Article I of the By-laws of FINRA) any member firm of FINRA; no relationship, direct or indirect, exists between or among the Company, on the one hand, and the executive directors, non-executive directors, officers or shareholders of the Company, on the other hand, which is required by the rules of FINRA to be described in the Registration Statement, the Pricing Prospectus and the Prospectus, which is not so described;
(rr) Neither the sale and delivery of the Shares nor the application of the proceeds thereof by the Company as described in the Pricing Prospectus and Prospectus will violate Regulation T, U or X of the Board of Governors of the Federal Reserve System or any other regulation of such Board of Governors;
(ss) The board of directors of the Company has determined in good faith that each member of its Audit Committee satisfies the Nasdaq and Commission independence standards applicable to the Company;
(tt) Neither the Company nor, to the Company’s knowledge, any of its affiliates (within the meaning of Rule 144 under the Act) has, prior to the date hereof, made any offer or sale of any securities which could be “integrated” (within the meaning of the Act) with the offer and sale of the Shares hereunder;
(uu) No forward-looking statement (within the meaning of Section 27A of the Act and Section 21E of the Exchange Act) included or incorporated by reference in any of the Registration Statement, the Pricing Prospectus or the Prospectus has been made or reaffirmed without a reasonable basis or has been disclosed other than in good faith;
(vv) Nothing has come to the attention of the Company that has caused the Company to believe that the statistical and market-related data included in each of the Registration Statement, the Pricing Prospectus and the Prospectus is not based on or derived from sources that are reliable and accurate in all material respects;
(ww) Except as described in the Pricing Prospectus and the Prospectus, the information technology assets and equipment, computers, systems, networks, hardware, software, websites, applications and databases owned by, or leased or licensed to, the Company or any of its subsidiaries (collectively, “IT Systems”), to the knowledge of the Company, are adequate for, and operate and perform in all material respects as required in connection with, the operation of the business of the Company and its subsidiaries as currently conducted, and to the Company’s knowledge are free and clear of all material bugs, errors, defects, Trojan horses, time bombs, malware and other corruptants; the Company and its subsidiaries have implemented and maintained commercially reasonable controls, policies, procedures, and safeguards to maintain and protect their material confidential information and the integrity, continuous operation, redundancy and security of all IT Systems and data (including all personal, personally identifiable, sensitive, confidential or regulated data of their respective customers, employees, suppliers, vendors and any third-party data maintained by or on behalf of them (“Personal Data”)) used in connection with their businesses; to the knowledge of the Company, there have been no material breaches, violations, outages, unauthorized uses of, accesses to or other compromise of or relating to any of
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the Company’s or any of its subsidiaries’ Personal Data or IT Systems, except for those that have been remedied without material cost or liability or the duty to notify any third party; there are no material incidents under internal review or investigations relating to any security breach or other compromise of the Company’s or any of its subsidiaries’ Personal Data or IT Systems and the Company and its subsidiaries have not been notified of, and have no knowledge of any event or condition that would reasonably be expected to result in, any security breach or other compromise to their IT Systems or Personal Data; the Company and its subsidiaries have implemented commercially reasonable backup and disaster recovery technology consistent with industry standards and practices; and the Company and its subsidiaries are presently in material compliance with all applicable laws or statutes and all judgments, orders, rules and regulations of any court or arbitrator or governmental or regulatory authority and internal policies, procedures and contractual obligations relating to the security of IT Systems and the privacy, collection, use, transfer, storage, protection, disposal or disclosure of Personal Data and to the protection of such IT Systems and Personal Data from unauthorized use, access, misappropriation or modification;
(xx) There are no debt securities, convertible securities or preferred shares issued or guaranteed by the Company or any of its subsidiaries that are rated by a “nationally recognized statistical rating organization”, as such term is defined in Section 3(a)(62) under the Exchange Act (a “Rating Organization”);
(yy) Neither the Company nor any of its subsidiaries or their respective properties or assets has immunity under Dutch, German, U.S. federal or New York state law from any legal action, suit or proceeding, from the giving of any relief in any such legal action, suit or proceeding, from set-off or counterclaim, from the jurisdiction of any Dutch, German, U.S. federal or New York state court, from service of process, attachment upon or prior to judgment, or attachment in aid of execution of judgment, or from execution of a judgment, or other legal process or proceeding for the giving of any relief or for the enforcement of a judgment, in any such court with respect to their respective obligations, liabilities or any other matter under or arising out of or in connection herewith; and, to the extent that the Company or any of its subsidiaries or any of their respective properties, assets or revenues may have or may hereafter become entitled to any such right of immunity in any such court in which proceedings arising out of, or relating to the transactions contemplated by this Agreement, may at any time be commenced, the Company has, pursuant to Section 18 of this Agreement, waived, and it will waive, or will cause its subsidiaries to waive, such right to the extent permitted by law;
(zz) Any final judgment for a fixed or determined sum of money rendered by any U.S. federal or New York state court located in the State of New York having jurisdiction under its own laws in respect of any suit, action or proceeding against the Company based upon this Agreement would generally be declared enforceable against the Company by the courts of the Netherlands, without reconsideration or reexamination of the merits;
(aaa) The choice of laws of the State of New York as the governing law of this Agreement is a valid choice of law under the laws of the Netherlands and subject to the provisions of Regulation (EC) No 593/2008 of the European Parliament and of the Council of 17 June 2008 relating to the law applicable to contractual obligations (Rome I), will be given effect to by the courts of the Netherlands, subject to the restrictions described under the caption “Enforcement of Judgments” in the Registration Statement, the Pricing Prospectus and the Prospectus; the Company has the power to submit, and pursuant to Section 18 of this Agreement, has legally, validly, effectively and irrevocably submitted, to the personal jurisdiction of each New York state and United States federal court sitting in the City of New York and has validly and irrevocably waived any objection to the laying of venue of any suit, action or proceeding brought in such court;
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(bbb) The indemnification and contribution provisions set forth in Sections 9 and 22 hereof do not contravene Dutch law or public policy;
(ccc) Subject to the qualifications and assumptions described in the Registration Statement and the Prospectus, the Company believes that it was not a “passive foreign investment company” (“PFIC”) as defined in Section 1297 of the Code for its most recently completed taxable year and the Company does not expect to be a PFIC for the current tax year;
(ddd) The legality, validity, enforceability or admissibility into evidence of any of the Registration Statement, the Pricing Disclosure Package, the Prospectus, this Agreement or the Shares in any jurisdiction in which the Company is organized or does business is not dependent upon such document being submitted into, filed or recorded with any court or other authority in any such jurisdiction (other than court filings in the ordinary course of proceedings) on or before the date that this representation is made or that any tax, imposition or charge (other than court fees or similar documentary tax payable in the ordinary course of proceedings) be paid in any such jurisdiction on or in respect of any such document;
(eee) A holder of the Shares and each Underwriter are each entitled to sue as plaintiff in the court of the jurisdiction of formation and domicile of the Company for the enforcement of its respective rights under this Agreement and the Shares and such access to such courts will not be subject to any conditions which are not applicable to residents of such jurisdiction or a company incorporated in such jurisdiction except that plaintiffs not residing in the Netherlands may be required to guarantee payment of a possible order for payment of costs or damages at the request of the defendant; provided, however, that the enforcement in the Netherlands of foreign judgements and arbitral awards is subject to the provisions of the Netherlands Code of Civil Procedure (Wetboek van Burgerlijke Rechtsvordering); and
(fff) The Company is a “foreign private issuer” as defined in Rule 405 under the Act.
2. Subject to the terms and conditions herein set forth, (a) the Company agrees to issue and sell to each of the Underwriters, and each of the Underwriters agrees, severally and not jointly, to purchase from the Company, at a purchase price per Share of $10.34, the number of Firm Shares set forth opposite the name of such Underwriter in Schedule I hereto and (b) in the event and to the extent that the Underwriters shall exercise the election to purchase Optional Shares as provided below, the Company agrees to issue and sell to each of the Underwriters, and each of the Underwriters agrees, severally and not jointly, to purchase from the Company, at the purchase price per share set forth in clause (a) of this Section 2 (provided that the purchase price per Optional Share shall be reduced by an amount per share equal to any dividends or distributions declared by the Company and payable on the Firm Shares but not payable on the Optional Shares), that portion of the number of Optional Shares as to which such election shall have been exercised (to be adjusted by you so as to eliminate fractional shares) determined by multiplying such number of Optional Shares by a fraction, the numerator of which is the maximum number of Optional Shares which such Underwriter is entitled to purchase as set forth opposite the name of such Underwriter in Schedule I hereto and the denominator of which is the maximum number of Optional Shares that all of the Underwriters are entitled to purchase hereunder.
The Company hereby grants to the Underwriters the right to purchase at their election up to 2,388,750 Optional Shares, at the purchase price per share set forth in the paragraph above, provided that the purchase price per Optional Share shall be reduced by an amount per share equal to any dividends or distributions declared by the Company and payable on the Firm Shares but not payable on the Optional Shares. Any such election to purchase Optional Shares may be exercised only by written notice from you to the
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Company, given within a period of 30 calendar days after the date of this Agreement, setting forth the aggregate number of Optional Shares to be purchased and the date on which such Optional Shares are to be delivered, as determined by you but in no event earlier than the First Time of Delivery (as defined in Section 4 hereof) or, unless you and the Company otherwise agree in writing, earlier than two or later than ten business days after the date of such notice.
3. Upon the authorization by you of the release of the Shares, the several Underwriters propose to offer the Shares for sale upon the terms and conditions set forth in the Pricing Prospectus and the Prospectus.
4. (a) The Shares to be purchased by each Underwriter hereunder, in definitive or book-entry form, and in such authorized denominations and registered in such names as the Representatives may request upon at least forty-eight hours’ prior notice to the Company shall be delivered by or on behalf of the Company to the Representatives, through the facilities of the Depository Trust Company (“DTC”), for the account of such Underwriter, against payment by or on behalf of such Underwriter of the purchase price therefor by wire transfer of Federal (same-day) funds to the account specified by the Company to the Representatives at least forty-eight hours in advance. The time and date of such delivery and payment for the Firm Shares shall be 9:30 a.m., New York City time, on January 22, 2024 or such other time and date as the Representatives and the Company may agree upon in writing, and, with respect to the Optional Shares, 9:30 a.m., New York time, on the date specified by the Representatives in the written notice given by the Representatives of the Underwriters’ election to purchase such Optional Shares, or such other time and date as the Representatives and the Company may agree upon in writing. Such time and date for delivery of the Firm Shares is herein called the “First Time of Delivery,” such time and date for delivery of the Optional Shares, if not the First Time of Delivery, is herein called the “Second Time of Delivery”, and each such time and date for delivery is herein called a “Time of Delivery.” Any payment by or on behalf of any Underwriter of a purchase price for any Shares pursuant to this Agreement shall, for Dutch law purposes, be deemed to be, and applied as, a payment on such Shares. Notwithstanding anything to the contrary herein, in no event shall the purchase price of any Share pursuant to this Agreement be less than the nominal value of such Share.
(b) The documents to be delivered at each Time of Delivery by or on behalf of the parties hereto pursuant to Section 8 hereof, including the cross receipt for the Shares and any additional documents requested by the Underwriters pursuant to Section 8(k) hereof, will be delivered at the offices of Covington & Burling LLP, The New York Times Building, 620 Eighth Avenue, New York, NY 10018 (the “Closing Location”), and the Shares will be delivered at the office of DTC or its designated custodian, all at such Time of Delivery. A meeting will be held at the Closing Location on the Business Day next preceding such Time of Delivery, at which meeting the final drafts of the documents to be delivered pursuant to the preceding sentence will be available for review by the parties hereto. “Business Day” shall mean each Monday, Tuesday, Wednesday, Thursday and Friday which is not a day on which banking institutions in New York are generally authorized or obligated by law or executive order to close.
5. The Company agrees with each of the Underwriters:
(a) To prepare the Prospectus in a form approved by you and to file such Prospectus pursuant to Rule 424(b) under the Act not later than the Commission’s close of business on the second Business Day following the date of this Agreement or such earlier time as may be required under the Act; to make no further amendment or any supplement to the Registration Statement, the Basic Prospectus or the Prospectus prior to the last Time of Delivery which shall be disapproved by you promptly after reasonable notice thereof; to advise you, promptly after it receives notice thereof, of the time when any amendment to the Registration Statement has been filed or becomes
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effective or any amendment or supplement to the Prospectus has been filed and to furnish you with copies thereof; to file promptly all material required to be filed by the Company with the Commission pursuant to Rule 433(d) under the Act; within the time required by such Rule; to file promptly all reports and any definitive proxy or information statements required to be filed by the Company with the Commission pursuant to Section 13(a), 13(c), 14 or 15(d) of the Exchange Act subsequent to the date of the Prospectus and for so long as the delivery of a prospectus (or in lieu thereof, the notice referred to in Rule 173(a) under the Act) is required in connection with the offering or sale of the Shares; to advise you, promptly after it receives notice thereof, of the issuance by the Commission of any stop order or of any order preventing or suspending the use of any Preliminary Prospectus or other prospectus in respect of the Shares, of the suspension of the qualification of the Shares for offering or sale in any jurisdiction, of the initiation or threatening of any proceeding for any such purpose, or of any request by the Commission for the amending or supplementing of the Registration Statement or the Prospectus or for additional information; and, in the event of the issuance of any stop order or of any order preventing or suspending the use of any Preliminary Prospectus or other prospectus or suspending any such qualification, to promptly use its best efforts to obtain the withdrawal of such order;
(b) To use its commercially reasonable efforts, in cooperation with the Representatives, to qualify the Shares for offering and sale, or to obtain an exemption for the Shares to be offered and sold, under the applicable securities laws of such states and other jurisdictions (domestic or foreign) as the Representatives may designate and to maintain such qualifications and exemptions in effect for so long as required for the distribution of the Shares (but in no event for less than one year from the date of this Agreement); provided, however, that the Company shall not be obligated to file any general consent to service of process or to qualify as a foreign corporation or as a dealer in securities in any jurisdiction in which it is not so qualified or to subject itself to taxation in respect of doing business in any jurisdiction in which it is not otherwise so subject; in each jurisdiction in which the Shares have been so qualified or exempt, the Company will file such statements and reports as may be required by the laws of such jurisdiction to continue such qualification or exemption, as the case may be, in effect for so long as required for the distribution of the Shares (but in no event for less than one year from the date of this Agreement);
(c) If, immediately prior to the third anniversary of the initial effective date of the Registration Statement (the “Renewal Date”), any of the Shares remain unsold by the Underwriters, the Company will, prior to the Renewal Date, file a new shelf registration statement or, if applicable, an automatic shelf registration statement relating to the Shares, in a form satisfactory to the Representatives and their counsel, and, if such registration statement is not an automatic shelf registration statement, will use its best efforts to cause such registration statement to be declared effective within 180 days after the Renewal Date; the Company will take all other reasonable actions necessary or appropriate to permit the public offer and sale of the Shares to continue as contemplated in the expired registration statement and this Agreement; from and after the effective date thereof, references herein to the “Registration Statement” shall include such new shelf registration statement or such new automatic shelf registration statement, as the case may be;
(d) Prior to 10:00 a.m., New York City time, on the second Business Day next succeeding the date of this Agreement and from time to time, to furnish the Underwriters with written and electronic copies of the Prospectus in New York City in such quantities as you may reasonably request, and, if the delivery of a prospectus (or in lieu thereof, the notice referred to in Rule 173(a) under the Act) is required at any time prior to the expiration of nine months after the time of issue of the Prospectus in connection with the offering or sale of the Shares and if at such time any event shall have occurred as a result of which the Prospectus as then amended or supplemented would include an untrue statement of a material fact or omit to state any material fact
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necessary in order to make the statements therein, in the light of the circumstances under which they were made when such Prospectus (or in lieu thereof, the notice referred to in Rule 173(a) under the Act) is delivered, not misleading, or, if for any other reason it shall be necessary during such same period to amend or supplement the Prospectus or to file under the Exchange Act any document incorporated by reference in the Prospectus in order to comply with the Act or the Exchange Act, to notify you and upon your request to file such document and to prepare and furnish without charge to each Underwriter and to any dealer in securities as many written and electronic copies as you may from time to time reasonably request of an amended Prospectus or a supplement to the Prospectus which will correct such statement or omission or effect such compliance; and in case any Underwriter is required to deliver a prospectus (or in lieu thereof, the notice referred to in Rule 173(a) under the Act) in connection with sales of any of the Shares at any time nine months or more after the time of issue of the Prospectus, upon your request but at the expense of such Underwriter, to prepare and deliver to such Underwriter as many written and electronic copies as you may request of an amended or supplemented Prospectus complying with Section 10(a)(3) of the Act; provided, however, that the Company shall not be required to furnish any document (other than such Prospectus) to the extent such document is available on the Commission’s Electronic Data Gathering Analysis and Retrieval System;
(e) To make generally available to its security holders as soon as practicable, but in any event not later than sixteen months after the effective date of the Registration Statement (as defined in Rule 158(c) under the Act), an earnings statement of the Company and its subsidiaries (which need not be audited) complying with Section 11(a) of the Act and the rules and regulations of the Commission thereunder (including, at the option of the Company, Rule 158);
(f) During the period beginning from the date hereof and continuing to and including the date 90 days after the date of the Prospectus (the “Lock-up Period”), not to (i) offer, sell, contract to sell, pledge, grant any option to purchase, make any short sale or otherwise transfer or dispose of, directly or indirectly, or file with the Commission a registration statement under the Act relating to, any securities of the Company that are substantially similar to the Shares, including but not limited to any options or warrants to purchase Ordinary Shares or any securities that are convertible into or exchangeable for, or that represent the right to receive, Ordinary Shares or any such substantially similar securities, or publicly disclose the intention to make any offer, sale, pledge, disposition or filing or (ii) enter into any swap or other agreement that transfers, in whole or in part, any of the economic consequences of ownership of Ordinary Shares or any such other securities, whether any such transaction described in clause (i) or (ii) above is to be settled by delivery of Ordinary Shares or such other securities, in cash or otherwise (other than the Shares to be sold hereunder or pursuant to employee stock option plans existing on, or upon the conversion or exchange of convertible or exchangeable securities outstanding as of, the date of this Agreement), without your prior written consent; provided, however, that such restrictions will not be required in connection with (s) issuance of the Shares being offered in this offering; (t) issuances of Ordinary Shares upon the exercise of an option or warrant or the conversion of or exchange for a security outstanding as of the date hereof and described in the Prospectus; (u) issuances to a third party or a group of third parties of Ordinary Shares or securities convertible into or exercisable or exchangeable for Ordinary Shares in connection with a merger, acquisition or other strategic or commercial relationship and the filing of a single registration statement, prospectus or prospectus supplement for the registration of the resale of such Ordinary Shares, provided that the aggregate number of Ordinary Shares issued or issuable under this clause (u) shall not exceed 5% of the total number of Ordinary Shares issued and outstanding immediately following the First Time of Delivery; (v) issuances, grants and settlements of Ordinary Shares or options to purchase Ordinary Shares or other securities granted pursuant to employee benefit plans existing as of the date hereof and described in the Prospectus; (w) the filing of any registration statement on Form S-8 in respect
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of any employee benefit plan in effect on the date hereof and described in the Prospectus; (x) facilitating the establishment of a trading plan pursuant to Rule 10b5-1 under the Exchange Act, provided that such plan does not provide for the transfer of Ordinary Shares during the Lock-up Period and no public announcement or filing under the Exchange Act is required or voluntarily made in connection with such plan; (y) the filing of a registration statement, prospectus or prospectus supplement for the registration of Ordinary Shares issuable upon the exercise of warrants outstanding on the date hereof and described in the Prospectus; and (z) the filing of a universal shelf registration statement and any amendments to such registration statement, provided that no sales of securities under such registration statement may be made during the Lock-up Period;
(g) If the Company elects to rely upon Rule 462(b), the Company shall file a Rule 462(b) Registration Statement with the Commission in compliance with Rule 462(b) by 10:00 p.m., Washington, D.C. time, on the date of this Agreement, and the Company shall at the time of filing either pay the Commission the filing fee for the Rule 462(b) Registration Statement or give irrevocable instructions for the payment of such fee pursuant to Rule 111(b) under the Act;
(h) [Reserved];
(i) To use the net proceeds received by it from the sale of the Shares in the manner specified in the Pricing Prospectus under the caption “Use of Proceeds”;
(j) To use its commercially reasonable efforts to cause the Shares, if and when issued, to be listed on Nasdaq;
(k) [Reserved];
(l) To not, directly or indirectly, and cause its officers, executive directors, non-executive directors and subsidiaries not to take any action designed to cause or result in, or that constitutes or might reasonably be expected to constitute, the stabilization or manipulation of the price of any security of the Company in connection with the offering of the Shares;
(m) To use its best efforts to comply with all requirements imposed upon it by the Act and the Exchange Act as from time to time in force, so far as necessary to permit the offer and sale of the Shares as contemplated by the provisions hereof and the Pricing Prospectus and Prospectus; and
(n) To maintain, at its sole expense, a transfer agent and registrar for the Ordinary Shares.
6. (a) The Company represents and agrees that, without the prior consent of the Representatives, it has not made and will not make any offer relating to the Shares that would constitute a “free writing prospectus” as defined in Rule 405 under the Act; each Underwriter represents and agrees that, without the prior consent of the Company and the Representatives, it has not made and will not make any offer relating to the Shares that would constitute a free writing prospectus required to be filed with the Commission; any such free writing prospectus the use of which has been consented to by the Company and the Representatives is listed on Schedule II(a) hereto;
(b) The Company has complied and will comply with the requirements of Rule 433 under the Act applicable to any Issuer Free Writing Prospectus, including timely filing with the Commission or retention where required and legending;
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(c) The Company agrees that if at any time following issuance of an Issuer Free Writing Prospectus or Written Testing-the-Waters Communication any event occurred or occurs as a result of which such Issuer Free Writing Prospectus or Written Testing-the-Waters Communication would conflict with the information in the Registration Statement, the Pricing Prospectus or the Prospectus or would include an untrue statement of a material fact or omit to state any material fact necessary in order to make the statements therein, in the light of the circumstances then prevailing, not misleading, the Company will give prompt notice thereof to the Representatives and, if requested by the Representatives, will prepare and furnish without charge to each Underwriter an Issuer Free Writing Prospectus, Written Testing-the-Waters Communication or other document which will correct such conflict, statement or omission; provided, however, that this representation and warranty shall not apply to any statements or omissions in an Issuer Free Writing Prospectus made in reliance upon and in conformity with the Underwriter Information;
(d) The Company represents and agrees that (i) it has not engaged in, or authorized any other person to engage in, any Testing-the-Waters Communications, other than Testing-the-Waters Communications with the prior consent of the Representatives with entities that the Company reasonably believes are qualified institutional buyers as defined in Rule 144A under the Act or institutions that are accredited investors as defined in Rule 501(a)(1), (a)(2), (a)(3), (a)(7) or (a)(8) under the Act; and (ii) it has not distributed, or authorized any other person to distribute, any Written Testing-the-Waters Communications, other than those distributed with the prior consent of the Representatives that are listed on Schedule II hereto; and the Company reconfirms that the Underwriters have been authorized to act on its behalf in engaging in Testing-the-Waters Communications; and
(e) Each Underwriter represents and agrees that any Written Testing-the-Waters Communications undertaken by it were with entities that are qualified institutional buyers as defined in Rule 144A under the Act or institutions that are accredited investors as defined in Rule 501(a)(1), (a)(2), (a)(3), (a)(7) or (a)(8) under the Act.
7. The Company covenants and agrees with the several Underwriters that the Company will pay or cause to be paid the following: (i) the fees, disbursements and expenses of the Company’s counsel and accountants in connection with the registration of the Shares under the Act and all other expenses in connection with the preparation, printing, reproduction and filing of the Registration Statement, the Basic Prospectus, any Preliminary Prospectus, any Written Testing-the-Waters Communication, any Issuer Free Writing Prospectus and the Prospectus and amendments and supplements thereto and the mailing and delivering of copies thereof to the Underwriters and dealers; (ii) the cost of printing or producing this Agreement, closing documents (including any compilations thereof) and any other documents in connection with the offering, purchase, sale and delivery of the Shares; (iii) reasonable and documented expenses incurred in connection with the qualification of the Shares for offering and sale under state securities laws as provided in Section 5(b) hereof, including the reasonable and documented fees and disbursements of counsel for the Underwriters in connection with such qualification and in connection with the Blue Sky survey(s) up to a maximum of $10,000; (iv) any filing fees incident to, and the fees and disbursements of counsel for the Underwriters in connection with, determining the offering’s compliance with FINRA’s rules and any required reviews by FINRA of the terms of the sale of the Shares up to a maximum of $25,000; (v) the cost of preparing certificates for the Shares; (vi) the cost and charges of any transfer agent or registrar or dividend disbursing agent; (vii) all fees and expenses in connection with listing the Shares on Nasdaq; and (viii) all other costs and expenses incident to the performance of its obligations hereunder which are not otherwise specifically provided for in this Section. It is understood, however, that, except as provided in this Section, and Sections 9 and 12 hereof, the Underwriters will pay all of their own costs and expenses, including the fees of their counsel, transfer taxes on resale of any of the Shares by them, and any advertising expenses connected with any offers they may make.
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8. The obligations of the Underwriters hereunder, as to the Shares to be delivered at each Time of Delivery, shall be subject, in their discretion, to the condition that all representations and warranties and other statements of the Company herein are, at and as of the Applicable Time and such Time of Delivery, true and correct, the condition that the Company shall have performed all of its obligations hereunder theretofore to be performed, and the following additional conditions:
(a) The Prospectus shall have been filed with the Commission pursuant to Rule 424(b) under the Act within the applicable time period prescribed for such filing by the rules and regulations under the Act and in accordance with Section 5(a) hereof; all material required to be filed by the Company pursuant to Rule 433(d) under the Act shall have been filed with the Commission within the applicable time period prescribed for such filings by Rule 433; if the Company has elected to rely upon Rule 462(b) under the Act, the Rule 462(b) Registration Statement shall have become effective by 10:00 p.m., Washington, D.C. time, on the date of this Agreement; no stop order suspending the effectiveness of the Registration Statement or any part thereof shall have been issued and no proceeding for that purpose or pursuant to Section 8A of the Act shall have been initiated or threatened by the Commission; no stop order suspending or preventing the use of the Pricing Prospectus, Prospectus or any Issuer Free Writing Prospectus shall have been initiated or threatened by the Commission; and all requests for additional information on the part of the Commission shall have been complied with to your reasonable satisfaction;
(b) Covington & Burling LLP, counsel for the Underwriters, shall have furnished to you such written opinion and negative assurance letter, dated such Time of Delivery in form and substance satisfactory to you, and such counsel shall have received such papers and information as they may reasonably request to enable them to pass upon such matters;
(c) Davis Polk & Wardwell LLP, counsel for the Company, shall have furnished to you their written opinion and negative assurance letter (a form of such opinion and negative assurance letter is attached as Annex I(a) hereto), dated such Time of Delivery, in form and substance satisfactory to you;
(d) NautaDutilh N.V., Dutch counsel for the Company, shall have furnished to you their written opinion (a form of such opinion is attached as Annex I(b) hereto), dated such Time of Delivery, in form and substance satisfactory to you;
(e) McBee Moore & Vanik IP, LLC, intellectual property counsel for the Company, shall have furnished to you their written opinion (a form of such opinion is attached as Annex I(c) hereto), dated such Time of Delivery, in form and substance satisfactory to you;
(f) On the date of the Prospectus, at 9:30 a.m., New York City time, on the effective date of any post-effective amendment to the Registration Statement filed subsequent to the date of this Agreement and also at each Time of Delivery, PricewaterhouseCoopers GmbH Wirtschaftsprüfungsgesellschaft, shall have furnished to you a letter or letters, dated the respective dates of delivery thereof, in form and substance satisfactory to you;
(g) Except as disclosed or contemplated in the Pricing Prospectus, there shall not have been (x) any material adverse change, on a consolidated basis, in the authorized share capital of the Company; (y) any Material Adverse Effect or any development that would reasonably be expected to result in a Material Adverse Effect, the effect of which, in the case of each of (i) and (ii), in the judgment of the Representatives (without relieving the Company of any obligation or liability it may otherwise have), is so material as to make it impracticable or inadvisable to proceed with the
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offering or delivery of the Shares being delivered at such Time of Delivery on the terms and in the manner contemplated in the Pricing Prospectus and the Prospectus;
(h) On or after the Applicable Time there shall not have occurred any of the following: (i) a suspension or limitation in trading in securities generally on Nasdaq; (ii) a suspension or limitation in trading in the Ordinary Shares on Nasdaq; (iii) a general banking moratorium shall have been declared by either United States federal or New York authorities or a material disruption in commercial banking or securities settlement or clearance services in the United States; (iv) any outbreak or escalation of national or international hostilities or (v) the occurrence of any other crisis or calamity, or any change in the United States or international political, financial or economic condition, if the effect of any such event specified in clause (iv) or (v) in your judgment makes it impracticable or inadvisable to proceed with the public offering or the delivery of the Shares being delivered at such Time of Delivery on the terms and in the manner contemplated in the Pricing Prospectus and the Prospectus;
(i) The Ordinary Shares shall not have been delisted from Nasdaq;
(j) The Company shall have complied with the provisions of Section 5(d) hereof with respect to the furnishing of prospectuses on the second Business Day next succeeding the date of this Agreement;
(k) The Company shall have furnished or caused to be furnished to you at such Time of Delivery certificates of officers of the Company satisfactory to you as to the accuracy of the representations and warranties of the Company herein at and as of such Time of Delivery, as to the performance by the Company of all of its obligations hereunder to be performed at or prior to such Time of Delivery, as to the matters set forth in subsections (a) and (g) of this Section and as to such other matters as you may reasonably request;
(l) The Company shall have furnished to you, on the date hereof and at such Time of Delivery, a certificate of the Chief Financial Officer of the Company in form and substance satisfactory to you; and
(m) The Company shall have obtained and delivered to the Underwriters executed copies of an agreement from each officer, executive director and non-executive director of the Company listed on Schedule III hereto, substantially to the effect set forth in Annex II hereto in form and substance satisfactory to you.
9. (a) The Company will indemnify and hold harmless each Underwriter against any losses, claims, damages or liabilities, joint or several, to which such Underwriter may become subject, under the Act or otherwise, insofar as such losses, claims, damages or liabilities (or actions in respect thereof) arise out of or are based upon an untrue statement or alleged untrue statement of a material fact contained in the Registration Statement, the Basic Prospectus, any Preliminary Prospectus, the Pricing Prospectus or the Prospectus, or any amendment or supplement thereto, any Issuer Free Writing Prospectus, any “roadshow” as defined in Rule 433(h) under the Act (a “roadshow”), any “issuer information” filed or required to be filed pursuant to Rule 433(d) under the Act or any Testing-the-Waters Communication, or arise out of or are based upon the omission or alleged omission to state therein a material fact required to be stated therein or necessary to make the statements therein not misleading, and will reimburse each Underwriter for any legal or other expenses reasonably incurred by such Underwriter in connection with investigating or defending any such action or claim as such expenses are incurred; provided, however, that the Company shall not be liable in any such case to the extent that any such loss, claim, damage or liability arises out of or is based upon an untrue statement or alleged untrue statement or omission or alleged omission made in
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the Registration Statement, the Basic Prospectus, any Preliminary Prospectus, the Pricing Prospectus or the Prospectus, or any amendment or supplement thereto, or any Issuer Free Writing Prospectus or any Testing-the-Waters Communication, in reliance upon and in conformity with the Underwriter Information.
(b) Each Underwriter will indemnify and hold harmless the Company against any losses, claims, damages or liabilities to which the Company may become subject, under the Act or otherwise, insofar as such losses, claims, damages or liabilities (or actions in respect thereof) arise out of or are based upon an untrue statement or alleged untrue statement of a material fact contained in the Registration Statement, the Basic Prospectus, any Preliminary Prospectus, the Pricing Prospectus or the Prospectus, or any amendment or supplement thereto, or any Issuer Free Writing Prospectus, or any roadshow or any Testing-the-Waters Communication, or arise out of or are based upon the omission or alleged omission to state therein a material fact required to be stated therein or necessary to make the statements therein not misleading, in each case to the extent, but only to the extent, that such untrue statement or alleged untrue statement or omission or alleged omission was made in the Registration Statement, the Basic Prospectus, any Preliminary Prospectus, the Pricing Prospectus or the Prospectus, or any amendment or supplement thereto, or any Issuer Free Writing Prospectus, or any roadshow or any Testing-the-Waters Communication, in reliance upon and in conformity with the Underwriter Information; and will reimburse the Company for any legal or other expenses reasonably incurred by the Company in connection with investigating or defending any such action or claim as such expenses are incurred. As used in this Agreement with respect to an Underwriter and an applicable document, “Underwriter Information” shall mean the written information furnished to the Company by such Underwriter through the Representatives expressly for use therein; it being understood and agreed upon that the only such information furnished by any Underwriter consists of the following information in the Prospectus furnished on behalf of each Underwriter: the concession figure appearing in the sixth paragraph under the caption “Underwriting”, and the information contained in the fourteenth, fifteenth and seventeenth paragraphs under the caption “Underwriting”.
(c) Promptly after receipt by an indemnified party under subsection (a) or (b) above of notice of the commencement of any action, such indemnified party shall, if a claim in respect thereof is to be made against the indemnifying party under such subsection, notify the indemnifying party in writing of the commencement thereof; provided that the failure to notify the indemnifying party shall not relieve it from any liability that it may have under the preceding paragraphs of this Section 9 except to the extent that it has been materially prejudiced (through the forfeiture of substantive rights or defenses) by such failure; and provided further that the failure to notify the indemnifying party shall not relieve it from any liability that it may have to an indemnified party otherwise than under the preceding paragraphs of this Section 9. In case any such action shall be brought against any indemnified party and it shall notify the indemnifying party of the commencement thereof, the indemnifying party shall be entitled to participate therein and, to the extent that it shall wish, jointly with any other indemnifying party similarly notified, to assume the defense thereof, with counsel satisfactory to such indemnified party (who shall not, except with the consent of the indemnified party, be counsel to the indemnifying party), and, after notice from the indemnifying party to such indemnified party of its election so to assume the defense thereof, the indemnifying party shall not be liable to such indemnified party under such subsection for any legal expenses of other counsel or any other expenses, in each case subsequently incurred by such indemnified party, in connection with the defense thereof other than reasonable costs of investigation. No indemnifying party shall, without the written consent of the indemnified party, effect the settlement or compromise of, or consent to the entry of any judgment with respect to, any pending or threatened action or claim in respect of which indemnification or contribution may be sought hereunder (whether or not the indemnified party is an actual or potential party to such action or claim) unless such settlement, compromise or judgment (i) includes an unconditional release of
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the indemnified party from all liability arising out of such action or claim and (ii) does not include any statement as to or an admission of fault, culpability or a failure to act, by or on behalf of any indemnified party.
(d) If the indemnification provided for in this Section 9 is unavailable to or insufficient to hold harmless an indemnified party under subsection (a) or (b) above in respect of any losses, claims, damages or liabilities (or actions in respect thereof) referred to therein, then each indemnifying party shall contribute to the amount paid or payable by such indemnified party as a result of such losses, claims, damages or liabilities (or actions in respect thereof) in such proportion as is appropriate to reflect the relative benefits received by the Company on the one hand and the Underwriters on the other from the offering of the Shares. If, however, the allocation provided by the immediately preceding sentence is not permitted by applicable law, then each indemnifying party shall contribute to such amount paid or payable by such indemnified party in such proportion as is appropriate to reflect not only such relative benefits but also the relative fault of the Company on the one hand and the Underwriters on the other in connection with the statements or omissions which resulted in such losses, claims, damages or liabilities (or actions in respect thereof), as well as any other relevant equitable considerations. The relative benefits received by the Company on the one hand and the Underwriters on the other shall be deemed to be in the same proportion as the total net proceeds from the offering (before deducting expenses) received by the Company bear to the total underwriting discounts and commissions received by the Underwriters, in each case as set forth in the table on the cover page of the Prospectus. The relative fault shall be determined by reference to, among other things, whether the untrue or alleged untrue statement of a material fact or the omission or alleged omission to state a material fact relates to information supplied by the Company on the one hand or the Underwriters on the other and the parties’ relative intent, knowledge, access to information and opportunity to correct or prevent such statement or omission. The Company and the Underwriters agree that it would not be just and equitable if contribution pursuant to this subsection (d) were determined by pro rata allocation (even if the Underwriters were treated as one entity for such purpose) or by any other method of allocation which does not take account of the equitable considerations referred to above in this subsection (d). The amount paid or payable by an indemnified party as a result of the losses, claims, damages or liabilities (or actions in respect thereof) referred to above in this subsection (d) shall be deemed to include any legal or other expenses reasonably incurred by such indemnified party in connection with investigating or defending any such action or claim. Notwithstanding the provisions of this subsection (d), no Underwriter shall be required to contribute any amount in excess of the amount by which the total price at which the Shares underwritten by it and distributed to the public were offered to the public exceeds the amount of any damages which such Underwriter has otherwise been required to pay by reason of such untrue or alleged untrue statement or omission or alleged omission. No person guilty of fraudulent misrepresentation (within the meaning of Section 11(f) of the Act) shall be entitled to contribution from any person who was not guilty of such fraudulent misrepresentation. The Underwriters’ obligations in this subsection (d) to contribute are several in proportion to their respective underwriting obligations and not joint.
(e) The obligations of the Company under this Section 9 shall be in addition to any liability which the Company may otherwise have and shall extend, upon the same terms and conditions, to each employee, officer and director of each Underwriter, each person, if any, who controls any Underwriter within the meaning of the Act and each broker-dealer or other affiliate of any Underwriter; and the obligations of the Underwriters under this Section 9 shall be in addition to any liability which the respective Underwriters may otherwise have and shall extend, upon the same terms and conditions, to each employee, officer, executive director and non-executive director of the Company and to each person, if any, who controls the Company within the meaning of the Act.
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10. (a) If any Underwriter shall default in its obligation to purchase the Shares which it has agreed to purchase hereunder at a Time of Delivery, you may in your discretion arrange for you or another party or other parties to purchase such Shares on the terms contained herein. If within thirty six hours after such default by any Underwriter you do not arrange for the purchase of such Shares, then the Company shall be entitled to a further period of thirty six hours within which to procure another party or other parties satisfactory to you to purchase such Shares on such terms. In the event that, within the respective prescribed periods, you notify the Company that you have so arranged for the purchase of such Shares, or the Company notifies you that it has so arranged for the purchase of such Shares, you or the Company shall have the right to postpone such Time of Delivery for a period of not more than seven days, in order to effect whatever changes may thereby be made necessary in the Registration Statement or the Prospectus, or in any other documents or arrangements, and the Company agrees to file promptly any amendments or supplements to the Registration Statement or the Prospectus which in your opinion may thereby be made necessary. The term “Underwriter” as used in this Agreement shall include any person substituted under this Section with like effect as if such person had originally been a party to this Agreement with respect to such Shares.
(b) If, after giving effect to any arrangements for the purchase of the Shares of a defaulting Underwriter or Underwriters by you and the Company as provided in subsection (a) above, the aggregate number of such Shares which remains unpurchased does not exceed one eleventh of the aggregate number of all the Shares to be purchased at such Time of Delivery, then the Company shall have the right to require each non defaulting Underwriter to purchase the number of shares which such Underwriter agreed to purchase hereunder at such Time of Delivery and, in addition, to require each non defaulting Underwriter to purchase its pro rata share (based on the number of Shares which such Underwriter agreed to purchase hereunder) of the Shares of such defaulting Underwriter or Underwriters for which such arrangements have not been made; but nothing herein shall relieve a defaulting Underwriter from liability for its default.
(c) If, after giving effect to any arrangements for the purchase of the Shares of a defaulting Underwriter or Underwriters by you and the Company as provided in subsection (a) above, the aggregate number of such Shares which remains unpurchased exceeds one eleventh of the aggregate number of all the Shares to be purchased at such Time of Delivery, or if the Company shall not exercise the right described in subsection (b) above to require non defaulting Underwriters to purchase Shares of a defaulting Underwriter or Underwriters, then this Agreement (or, with respect to the Second Time of Delivery, the obligations of the Underwriters to purchase and of the Company to sell the Optional Shares) shall thereupon terminate, without liability on the part of any non-defaulting Underwriter or the Company, except for the expenses to be borne by the Company and the Underwriters as provided in Section 7 hereof and the indemnity and contribution agreements in Section 9 hereof; but nothing herein shall relieve a defaulting Underwriter from liability for its default.
11. The respective indemnities, rights of contribution, agreements, representations, warranties and other statements of the Company and the several Underwriters, as set forth in this Agreement or made by or on behalf of them, respectively, pursuant to this Agreement, shall remain in full force and effect, regardless of any investigation (or any statement as to the results thereof) made by or on behalf of any Underwriter or any director, officer, employee, affiliate or controlling person of any Underwriter, or the Company, or any officer, executive director or non-executive director or controlling person of the Company, and shall survive delivery of and payment for the Shares.
12. If this Agreement shall be terminated pursuant to Section 10 hereof, the Company shall not then be under any liability to any Underwriter except as provided in Sections 7 and 9 hereof; but, if for any other reason, any Shares are not delivered by or on behalf of the Company as provided herein, the Company will reimburse the Underwriters through you for all out of pocket expenses approved in writing by you,
| 27 |
including fees and disbursements of counsel, reasonably incurred by the Underwriters in making preparations for the purchase, sale and delivery of the Shares not so delivered, but the Company shall then be under no further liability to any Underwriter except as provided in Sections 7 and 9 hereof.
13. In all dealings hereunder, you shall act on behalf of each of the Underwriters, and the parties hereto shall be entitled to act and rely upon any statement, request, notice or agreement on behalf of any Underwriter made or given by you.
All statements, requests, notices and agreements hereunder shall be in writing, and if to the Underwriters shall be delivered or sent by mail or facsimile transmission to you as the Representatives at Jefferies LLC and Jefferies GmbH, 520 Madison Avenue, New York, NY 10022, Attention: General Counsel, Facsimile: (646) 619-4437; BofA Securities, Inc., One Bryant Park, New York, NY 10036, email: dg.ecm_execution_services@bofa.com, Attention: Syndicate Department, with a copy to dg.ecm_legal@bofa.com, Attention: ECM Legal; Leerink Partners LLC, 1301 Avenue of the Americas, 12th Floor, New York, NY 10019, Attention: Stuart R. Nayman, Esq., Facsimile: (646) 499-7051; with a copy (which shall not constitute notice) to Covington & Burling LLP, The New York Times Building, 620 Eighth Avenue, New York, NY 10018, Attention: Matthew T. Gehl, Facsimile: (646) 441-9111; and if to the Company shall be delivered or sent by mail or facsimile transmission to 72076 Tübingen, Federal Republic of Germany, Attention: Secretary; with copies (which shall not constitute notice) to Davis Polk & Wardwell LLP, 450 Lexington Avenue, New York, NY 10017, Attention: Yasin Keshvargar, Facsimile: (212) 701-5839 and NautaDutilh N.V., Beethovenstraat 400, 1082 PR Amsterdam, Attention: Paul van der Bijl; provided, however, that any notice to an Underwriter pursuant to Section 9(c) hereof shall be delivered or sent by mail or facsimile transmission to such Underwriter at its address set forth in its Underwriters’ Questionnaire, or telex constituting such Questionnaire, which address will be supplied to the Company by you upon request. Any such statements, requests, notices or agreements shall take effect upon receipt thereof.
In accordance with the requirements of the USA Patriot Act (Title III of Pub. L. 107-56 (signed into law October 26, 2001)), the Underwriters are required to obtain, verify and record information that identifies their respective clients, including the Company, which information may include the name and address of their respective clients, as well as other information that will allow the underwriters to properly identify their respective clients.
14. This Agreement shall be binding upon, and inure solely to the benefit of, the Underwriters, the Company and, to the extent provided in Section 9 hereof, the officers and directors of the Company and each person who controls the Company or any Underwriter, or any director, officer, employee, or affiliate of any Underwriter, and their respective heirs, executors, administrators, successors and assigns, and no other person shall acquire or have any right under or by virtue of this Agreement. No purchaser of any of the Shares from any Underwriter shall be deemed a successor or assign by reason merely of such purchase.
15. Time shall be of the essence of this Agreement.
16. The Company acknowledges and agrees that (i) the purchase and sale of the Shares pursuant to this Agreement is an arm’s-length commercial transaction between the Company, on the one hand, and the several Underwriters, on the other, (ii) in connection therewith and with the process leading to such transaction each Underwriter is acting solely as a principal and not the agent or fiduciary of the Company, (iii) no Underwriter has assumed an advisory or fiduciary responsibility in favor of the Company with respect to the offering contemplated hereby or the process leading thereto (irrespective of whether such Underwriter has advised or is currently advising the Company on other matters) or any other obligation to the Company except the obligations expressly set forth in this Agreement, (iv) the Company has consulted its own legal and financial advisors to the extent it deemed appropriate, and (v) none of the
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activities of the Underwriters in connection with the transactions contemplated herein constitutes a recommendation, investment advice, or solicitation of any action by the Underwriters with respect to any entity or natural person. The Company agrees that it will not claim that the Underwriters, or any of them, has rendered advisory services of any nature or respect, or owes a fiduciary or similar duty to the Company, in connection with such transaction or the process leading thereto.
17. This Agreement supersedes all prior agreements and understandings (whether written or oral) between the Company and the Underwriters, or any of them, with respect to the subject matter hereof.
18. Each party hereby irrevocably submits to the exclusive jurisdiction of the state and federal courts sitting in the City of New York, Borough of Manhattan, for the adjudication of any dispute hereunder or in connection with any of the transactions contemplated hereby, and hereby irrevocably waives, and agrees not to assert in any suit, action or proceeding, any claim that it is not personally subject to the jurisdiction of any such court, that such suit, action or proceeding is brought in an inconvenient forum, or that the venue of such suit, action or proceeding is improper. Each party hereby irrevocably waives personal service of process and consents to process being served in any such suit, action or proceeding by mailing a copy (certified or registered mail, return receipt requested) to such party at the address in effect for notices under Section 13 of this Agreement and agrees that such service shall constitute good and sufficient notice of process and notice thereof. Nothing contained herein shall be deemed to limit in any way any right to serve process in any manner permitted by law. The Company hereby irrevocably appoints Edward A. Sturchio of Immatics US, Inc., which currently maintains an office at 2130 W. Holcombe Blvd., Suite 900, Houston, Texas 77030 as its agent to receive service of process or other legal summons for purposes of any such suit, action or proceeding that may be instituted in any state or federal court in the Borough of Manhattan in the City of New York, United States of America. To the extent that the Company has or hereafter may acquire any immunity (sovereign or otherwise) from jurisdiction of any court of (i) the Netherlands, (ii) the United States or the State of New York, (iii) any jurisdiction in which it owns or leases property or assets or from any legal process (whether through service of notice, attachment prior to judgment, attachment in aid of execution, execution, set-off or otherwise) with respect to itself or its respective property and assets or this Agreement, the Company hereby irrevocably waives such immunity in respect of its obligations under this Agreement to the fullest extent permitted by applicable law.
19. The Company and each of the Underwriters hereby irrevocably waives, to the fullest extent permitted by applicable law, any and all right to trial by jury in any legal proceeding arising out of or relating to this Agreement or the transactions contemplated hereby.
20. Notwithstanding anything herein to the contrary, the Company is authorized to disclose to any persons U.S. federal and state tax treatment and tax structure of the potential transaction and all materials of any kind (including tax opinions and other tax analyses) provided to the Company relating to that treatment and structure, without the Underwriters imposing any limitation of any kind. However, any information relating to the tax treatment and tax structure shall remain confidential (and the foregoing sentence shall not apply) to the extent necessary to enable any person to comply with securities laws. For this purpose, “tax structure” is limited to any facts that may be relevant to that treatment.
21. This Agreement may be executed by any one or more of the parties hereto in any number of counterparts, each of which shall be deemed to be an original, but all such counterparts shall together constitute one and the same instrument. Counterparts may be delivered via facsimile, electronic mail (including any electronic signature covered by the U.S. federal ESIGN Act of 2000, Uniform Electronic Transactions Act, the Electronic Signatures and Records Act or other applicable law, e.g., www.docusign.com) or other transmission method and any counterpart so delivered shall be deemed to have been duly and validly delivered and be valid and effective for all purposes.
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22. Currency Provisions.
(a) The Company agrees to indemnify each Underwriter, each employee, officer and director of each Underwriter and each person, if any, who controls any Underwriter within the meaning of the Act and each broker-dealer or other affiliate of any Underwriter, against any loss incurred as a result of any judgment or order being given or made for any amount due hereunder and such judgment or order being expressed and paid in a currency (the “judgment currency”) other than U.S. dollars and as a result of any variation as between (i) the rate of exchange at which the U.S. dollar amount is converted into the judgment currency for the purpose of such judgment or order, and (ii) the rate of exchange at which such indemnified person is able to purchase U.S. dollars with the amount of the judgment currency actually received by the indemnified person. The foregoing indemnity shall constitute a separate and independent obligation of the Company and shall continue in full force and effect notwithstanding any such judgment or order as aforesaid. The term “rate of exchange” shall include any premiums and costs of exchange payable in connection with the purchase of, or conversion into, the relevant currency.
(b) The Company will indemnify and hold harmless the Underwriters against any documentary, stamp or similar issue tax, including any interest and penalties, on the issue and sale of the Shares by the Company to the Underwriters and on the execution and delivery of this Agreement. All payments made by the Company under this Agreement shall be made free and clear of any withholding or deduction for or on account of any present or future taxes, duties, assessments or governmental charges of whatever nature (including any amounts that result from the payment of fees, compensation or reimbursement of costs contemplated by this Agreement) imposed or levied by or on behalf of the Netherlands or by any department, agency or other political subdivision or any taxing authority thereof or therein, and all interest, penalties or similar liabilities with respect thereto (collectively, “Dutch Taxes”), unless such deduction or withholding is required by law. If any Dutch Taxes are required by law to be deducted or withheld by the Company in connection with such payment or repurchase, the Company will increase the amount to be paid to the applicable Underwriter so that the full amount of such payment is received by such Underwriter; provided that the Company will not be required to pay any such additional amounts to the extent that the obligation to withhold or deduct any amounts arises as a result of any present or former connection between such Underwriter and the relevant jurisdiction other than any such connection arising solely as a result of the transaction described in this Agreement.
23. Recognition of the U.S. Special Resolution Regimes.
(a) In the event that any Underwriter that is a Covered Entity becomes subject to a proceeding under a U.S. Special Resolution Regime, the transfer from such Underwriter of this Agreement, and any interest and obligation in or under this Agreement, will be effective to the same extent as the transfer would be effective under the U.S. Special Resolution Regime if this Agreement, and any such interest and obligation, were governed by the laws of the United States or a state of the United States.
(b) In the event that any Underwriter that is a Covered Entity or a BHC Act Affiliate of such Underwriter becomes subject to a proceeding under a U.S. Special Resolution Regime, Default Rights under this Agreement that may be exercised against such Underwriter are permitted to be exercised to no greater extent than such Default Rights could be exercised under the U.S. Special Resolution Regime if this Agreement were governed by the laws of the United States or a state of the United States.
(c) As used in this section:
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“BHC Act Affiliate” has the meaning assigned to the term “affiliate” in, and shall be interpreted in accordance with, 12 U.S.C. § 1841(k).
“Covered Entity” means any of the following:
| (i) | a “covered entity” as that term is defined in, and interpreted in accordance with, 12 C.F.R. § 252.82(b); |
| (ii) | a “covered bank” as that term is defined in, and interpreted in accordance with, 12 C.F.R. § 47.3(b); or |
| (iii) | a “covered FSI” as that term is defined in, and interpreted in accordance with, 12 C.F.R. § 382.2(b). |
“Default Right” has the meaning assigned to that term in, and shall be interpreted in accordance with, 12 C.F.R. §§ 252.81, 47.2 or 382.1, as applicable.
“U.S. Special Resolution Regime” means each of (i) the Federal Deposit Insurance Act and the regulations promulgated thereunder and (ii) Title II of the Dodd-Frank Wall Street Reform and Consumer Protection Act and the regulations promulgated thereunder.
24. Contractual Recognition of EU Bail-in.
(a) Notwithstanding and to the exclusion of any other term of this Agreement or any other agreements, arrangements, or understanding between any of the parties hereto, the Company acknowledges and accepts that a EU BRRD Liability arising under this Agreement may be subject to the exercise of EU Bail-in Powers by the Relevant EU Resolution Authority, and acknowledges, accepts and agrees to be bound by
(i) the effect of the exercise of EU Bail-in Powers by the Relevant EU Resolution Authority in relation to any EU BRRD Liability of any Underwriter to the Company under this Agreement, that (without limitation) may include and result in any of the following, or some combination thereof:
(A) the reduction of all, or a portion, of the EU BRRD Liability or outstanding amounts due thereon;
(B) the conversion of all, or a portion, of the EU BRRD Liability into shares, other securities or other obligations of the Underwriters or another person, and the issue to or conferral on the Company of such shares, securities or obligations;
(C) the cancellation of the EU BRRD Liability; and/or
(D) the amendment or alteration of any interest, if applicable, thereon, the maturity or the dates on which any payments are due, including by suspending payment for a temporary period; and
(ii) the variation of the terms of this Agreement, as deemed necessary by the Relevant EU Resolution Authority, to give effect to the exercise of EU Bail-in Powers by the Relevant EU Resolution Authority.
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(b) For purposes of this Section 24:
“EU Bail-in Legislation” means in relation to a member state of the European Economic Area which has implemented, or which at any time implements, the EU BRRD, the relevant implementing law, regulation, rule or requirement as described in the EU Bail-in Legislation Schedule from time to time.
“EU Bail-in Powers” means any EU Write-down and Conversion Powers in relation to the relevant EU Bail-in Legislation.
“EU BRRD” means Directive 2014/59/EU establishing a framework for the recovery and resolution of credit institutions and investment firms, as amended.
“EU BRRD Liability” means a liability in respect of which the relevant EU Write Down and Conversion Powers in the applicable EU Bail-in Legislation may be exercised.
“EU Bail-in Legislation Schedule” means the document described as such, then in effect, and published by the Loan Market Association (or any successor person) from time to time at https://www.lma.eu.com/documents-guidelines/eu-bail-legislation-schedule (or any such successor webpage).
“EU Write-down and Conversion Powers” has the meaning given to it in the EU Bail-in Legislation Schedule.
“Relevant EU Resolution Authority” means the resolution authority with the ability to exercise any Bail-in Powers in relation to a particular Underwriter.
If the foregoing is in accordance with your understanding, please sign and return to us counterparts hereof, and upon the acceptance hereof by you, on behalf of each of the Underwriters, this letter and such acceptance hereof shall constitute a binding agreement between each of the Underwriters and the Company. It is understood that your acceptance of this letter on behalf of each of the Underwriters is pursuant to the authority set forth in a form of Agreement among Underwriters, the form of which shall be submitted to the Company for examination upon request, but without warranty on your part as to the authority of the signers thereof.
[Signature page follows]
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| Very truly yours, | |
| IMMATICS N.V. | |
| By: /s/ Arnd Christ | |
| Name: Arnd Christ | |
| Title: CFO |
| Accepted as of the date hereof: | |
| JEFFERIES LLC | |
| JEFFERIES GMBH | |
| BOFA SECURITIES, INC. | |
| LEERINK PARTNERS LLC | |
Acting individually and as Representatives of the several Underwriters named in the attached Schedule I. |
| JEFFERIES LLC | |
| By: /s/ Charles Glazer | |
| Name: Charles Glazer | |
| Title: Managing Director |
| JEFFERIES GMBH | JEFFERIES GMBH |
| By: /s/ Gil Bar-Nahum | By: /s/ Oliver Diehl |
| Name: Gil Bar-Nahum | Name: Oliver Diehl |
| Title: Managing Director | Title: Managing Director |
| BOFA SECURITIES, INC. | |
| By: /s/ John Bishai | |
| Name: John Bishai | |
| Title: Managing Director |
| LEERINK PARTNERS LLC | |
| By: /s/ Dan Dubin, M.D. | |
| Name: Dan Dubin, M.D. | |
| Title: Vice Chairman, Global Co-Head of Investment Banking |
SCHEDULE I
| Underwriter | Number of Firm Shares to be Purchased | Maximum Number of Optional Shares Which May be Purchased | ||||||
| Jefferies LLC | 5,414,500 | 812,176 | ||||||
| BofA Securities, Inc. | 5,255,250 | 788,287 | ||||||
| Leerink Partners LLC | 5,255,250 | 788,287 | ||||||
| Total | 15,925,000 | 2,388,750 | ||||||
SCHEDULE II
(a) Issuer Free Writing Prospectuses not included in the Pricing Disclosure Package:
None
(b) Additional Documents Incorporated by Reference:
None
(c) Information other than the Pricing Prospectus that comprise the Pricing Disclosure Package:
The initial public offering price per share for the Shares is $11.00.
The number of Firm Shares purchased by the Underwriters is 15,925,000.
The number of Optional Shares that may be purchased by the Underwriters is 2,388,750.
(d) Written Testing-the-Waters Communications:
Corporate Presentation dated January 2024
Recent Development Disclosure dated January 2024
SCHEDULE III
| 1. | Harpreet Singh, Ph.D. |
| 2. | Arnd Christ |
| 3. | Cedrik Britten, M.D. |
| 4. | Carsten Reinhardt, M.D., Ph.D. |
| 5. | Toni Weinschenk, Ph.D. |
| 6. | Rainer Kramer, Ph.D. |
| 7. | Steffen Walter, Ph.D. |
| 8. | Edward Sturchio |
| 9. | Jordan Silverstein |
| 10. | Peter Chambré |
| 11. | Michael G. Atieh |
| 12. | Paul R. Carter, FCMA |
| 13. | Eliot Forster, Ph.D. |
| 14. | Heather L. Mason |
| 15. | Adam Stone |
| 16. | Mathias Hothum, Ph.D. |
ANNEX I(a)
FORM OF OPINION AND NEGATIVE ASSURANCE LETTER
OF DAVIS POLK & WARDWELL LLP
ANNEX I(b)
FORM OF OPINION OF NAUTA DUTILH N.V.
ANNEX I(c)
FORM OF OPINION OF MCBEE MOORE & VANIK IP, LLC
ANNEX II
FORM OF LOCK-UP AGREEMENT
Lock-Up Agreement
January ___, 2024
Jefferies LLC
520 Madison Avenue
New York, NY 10022
Jefferies GmbH
Bockenheimer Landstr. 24
60323 Frankfurt am Main
BofA Securities, Inc.
One Bryant Park
New York, NY 10036
Leerink Partners LLC
1301 Avenue of the Americas, 12th Floor
New York, NY 10019
Re: Immatics N.V. - Lock-Up Agreement
Ladies and Gentlemen:
The undersigned understands that you, as representatives (the “Representatives”), propose to enter into an Underwriting Agreement (the “Underwriting Agreement”) on behalf of the several Underwriters named in Schedule I to such agreement (collectively, the “Underwriters”), with Immatics N.V., a public limited company (naamloze vennootschap) under Dutch law (the “Company”), providing for a public offering (the “Offering”) of securities of the Company (the “Securities”) pursuant to a Registration Statement on Form F-3 filed with the Securities and Exchange Commission.
In consideration of the agreement by the Underwriters to offer and sell the Securities, and of other good and valuable consideration the receipt and sufficiency of which is hereby acknowledged, the undersigned agrees that, during the period (the “Lock-Up Period”) beginning from the date hereof and continuing to and including the date 90 days after the date of the final prospectus covering the public offering of the Securities (the “Prospectus”), the undersigned shall not, and shall not cause or direct any of its affiliates to, (i) offer, sell, contract to sell, pledge, grant any option to purchase, lend or otherwise dispose of any ordinary shares of the Company, nominal value €0.01 per share (the “Ordinary Shares”), or any options or warrants to purchase any Ordinary Shares, or any securities convertible into, exchangeable for or that represent the right to receive Ordinary Shares (such options, warrants or other securities, collectively, “Derivative Instruments”), including without limitation any such Ordinary Shares or Derivative Instruments now owned or hereafter acquired by the undersigned, (ii) engage in any hedging or other transaction or arrangement (including, without limitation, any short sale or the purchase or sale of, or entry into, any put or call option, or combination thereof, forward, swap or any other derivative transaction or instrument, however described or defined) which is designed to or which reasonably could be expected to lead to or result in a sale, loan, pledge or other disposition (whether by the undersigned or someone other than the undersigned), or transfer of any of the economic consequences of ownership, in whole or in part, directly or indirectly, of any Ordinary Shares or Derivative Instruments, whether any such transaction or arrangement (or instrument provided for thereunder) would be settled by delivery of Ordinary Shares or other securities, in cash or otherwise (any such sale, loan, pledge or other disposition, or transfer of economic consequences, a “Transfer”) or (iii) otherwise publicly announce any intention to engage in or cause any action or activity described in clause (i) above or
transaction or arrangement described in clause (ii) above. The undersigned represents and warrants that the undersigned is not, and has not caused or directed any of its affiliates to be or become, currently a party to any agreement or arrangement that provides for, is designed to or which reasonably could be expected to lead to or result in any Transfer during the Lock-Up Period.
If the undersigned is not a natural person, the undersigned represents and warrants that no single natural person, entity or “group” (within the meaning of Section 13(d)(3) of the Securities Exchange Act of 1934, as amended), other than a natural person, entity or “group” (as described above) that has executed a Lock-Up Agreement in substantially the same form as this Lock-Up Agreement, beneficially owns, directly or indirectly, 50% or more of the common equity interests, or 50% or more of the voting power, in the undersigned.
Notwithstanding the foregoing, the undersigned may transfer the undersigned’s Ordinary Shares or Derivative Instruments:
| (i) | as a bona fide gift or gifts; |
| (ii) | by will or intestacy; |
| (iii) | by operation of law, such as pursuant to a qualified domestic order, divorce settlement, divorce decree or separation agreement or other court or regulatory agency order; |
| (iv) | to any member of the immediate family of the undersigned, any trust for the direct or indirect benefit of the undersigned or the immediate family of the undersigned or any corporation, partnership, limited liability company or other entity of which the undersigned and the immediate family of the undersigned are the legal and beneficial owner of all of the outstanding equity securities or similar interests; |
| (v) | in connection with the establishment of a trading plan pursuant to Rule 10b5-1 under the Securities Exchange Act of 1934, as amended (the “Exchange Act”), provided that such plan does not provide for the transfer of Ordinary Shares or Derivative Instruments during the Lock-Up Period; |
| (vi) | pursuant to any trading plan pursuant to Rule 10b5-1 under the Exchange Act that has been entered into by the undersigned prior to the date of the Underwriting Agreement; |
| (vii) | in connection with the conversion, exercise or exchange of warrants to purchase Ordinary Shares (including transfers to the Company in connection with the “net” or “cashless” exercise of warrants) outstanding as of the date of the Underwriting Agreement and described in the Prospectus, provided that any securities received upon such conversion, exercise or exchange shall remain subject to the restrictions set forth in this Lock-Up Agreement; |
| (viii) | in connection with the exercise of options to purchase Ordinary Shares or other securities (including transfers to the Company in connection with the “net” or “cashless” exercise of options or such other securities) received pursuant to employee benefit or other compensation plans, provided that such plan exists as of the date of the Underwriting Agreement and is described in the Prospectus, and provided further that any Ordinary Shares received upon such exercise shall remain subject to the restrictions set forth in this Lock-Up Agreement; |
| (ix) | if the undersigned is a business entity, (A) to another business entity that is an affiliate (as defined in Rule 405 promulgated under the Securities Act of 1933, as amended) of the undersigned, or to any investment fund or other entity that controls or manages, or is under common control with, the undersigned or (B) to the undersigned’s limited partners, members or shareholders; |
| (x) | pursuant to a bona fide third-party tender offer, merger, consolidation or other similar transaction that is approved by the Board of Directors of the Company and made to all holders of the Company’s capital stock involving a Change of Control (as defined below) of the Company, provided that, in the event that such tender offer, merger, consolidation or other similar transaction is not completed, the |
undersigned’s Ordinary Shares and Derivative Instruments shall remain subject to the provisions of this Lock-Up Agreement;
| (xi) | with the prior written consent of each of the Representatives on behalf of the Underwriters; |
| (xii) | to the Company, if such transfer is required by the Company’s policy with respect to the recoupment of incentive-based compensation; |
provided further that, (a) in cases of clauses (i), (iv) and (ix) above, no public announcement or filing under the Exchange Act shall be made during the Lock-Up Period, (b) in cases of clauses (ii), (iii), (vi), (vii), (viii) and (x) above, no public announcement or filing under the Exchange Act shall be voluntarily made during the Lock-Up Period and any required filings under the Exchange Act during the Lock-Up Period shall clearly indicate the circumstances, nature and conditions of such transfer or disposition, (c) in cases of clauses (i), (ii), (iii), (iv) and (ix) above, such transfer shall not involve a disposition for value, (d) in cases of clauses (i), (iv) and (ix) above, the recipient thereof agrees to be bound in writing by the restrictions set forth herein and (e) in the case of clause (v) above, any public announcement or filing shall indicate that such plan does not provide for the transfer of Ordinary Shares or Derivative Instruments during the Lock-Up Period.
For purposes of this Lock-Up Agreement, “immediate family” shall mean any relationship by blood, marriage or adoption, not more remote than first cousin. For the purposes of this Lock-Up Agreement, “Change of Control” shall mean the transfer (whether by tender offer, merger, consolidation or other similar transaction), in one transaction or a series of related transactions, to a person or group of affiliated persons, of shares of capital stock if, after such transfer, such person or group of affiliated persons would hold at least a majority of the outstanding voting securities of the Company (or the surviving entity).
The undersigned’s Ordinary Shares and Derivative Instruments are held by it free and clear of all liens, encumbrances, and claims whatsoever. The undersigned agrees and consents to the entry of stop transfer instructions with the Company’s transfer agent and registrar against the transfer of the undersigned’s Ordinary Shares except in compliance with the foregoing restrictions.
The undersigned acknowledges and agrees that the Underwriters have not made any recommendation or provided any investment advice to the undersigned with respect to this Lock-Up Agreement or the subject matter hereof, and the undersigned has consulted its own legal, accounting, financial, regulatory and tax advisors with respect to this Lock-Up Agreement and the subject matter hereof to the extent the undersigned has deemed appropriate.
This Lock-Up Agreement shall be of no force or effect if (i) the Representatives or the Company inform the other in writing, prior to the execution of the Underwriting Agreement, that they have determined not to proceed with the Offering, (ii) the Underwriting Agreement does not become effective by February 15, 2024, or (iii) the Underwriting Agreement (other than the provisions thereof which survive termination) shall terminate or be terminated prior to payment for and delivery of the Securities to be sold thereunder.
The undersigned understands that the Company and the Underwriters are relying upon this Lock-Up Agreement in proceeding toward consummation of the Offering. The undersigned further understands that this Lock-Up Agreement is irrevocable and shall be binding upon the undersigned’s heirs, legal representatives, successors, and assigns.
Very truly yours,
Exact Name of Shareholder: ___________________________________
Authorized Signature: _______________________________________
Title: ____________________________________________________
Exhibit 5.1
| ATTORNEYS • CIVIL LAW NOTARIES • TAX ADVISERS |  | |
|
Beethovenstraat 400 1082 PR Amsterdam T +31 20 71 71 000 F +31 20 71 71 111 |
Amsterdam, January 22, 2024.
| |
To the Company:
We have acted as legal counsel as to Dutch law to the Company in connection with the Offering and the filing of the Registration Statement with the SEC. This opinion letter is rendered to you in order to be filed with the SEC as an exhibit to the Registration Statement.
Capitalised terms used in this opinion letter have the meanings set forth in Exhibit A to this opinion letter. The section headings used in this opinion letter are for convenience of reference only and are not to affect its construction or to be taken into consideration in its interpretation.
This opinion letter is strictly limited to the matters stated in it and may not be read as extending by implication to any matters not specifically referred to in it. Nothing in this opinion letter should be taken as expressing an opinion in respect of any representations or warranties, or other information, contained in any document reviewed by us in connection with this opinion letter.
In rendering the opinions expressed in this opinion letter, we have reviewed and relied upon drafts of the Reviewed Documents, a draft of the Registration Statement and pdf copies or drafts, as the case may be, of the Corporate Documents and we have assumed that the Reviewed Documents shall be entered into for bona fide commercial reasons. We have not investigated or verified any factual matter disclosed to us in the course of our review.
This opinion letter sets out our opinion on certain matters of the laws with general applicability of the Netherlands, and, insofar as they are directly applicable in the Netherlands, of the European Union, as at today's date and as presently interpreted under published authoritative case law of the Dutch courts, the General Court and the Court of Justice of the European Union. We do not express any opinion on Dutch or European competition law, data protection law, tax law, securitisation law or regulatory law. No undertaking is assumed on our part to revise, update or amend this opinion letter in connection with, or to notify or inform you of, any developments and/or changes of Dutch law subsequent to today's date. We do not purport to opine on the consequences of amendments to the Reviewed Documents, the Registration Statement or the Corporate Documents subsequent to the date of this opinion letter.
The opinions expressed in this opinion letter are to be construed and interpreted in accordance with Dutch law. The competent courts at Amsterdam, the Netherlands, have exclusive jurisdiction to settle any issues of interpretation or liability arising
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out of or in connection with this opinion letter. Any legal relationship arising out of or in connection with this opinion letter (whether contractual or non-contractual), including the above submission to jurisdiction, is governed by Dutch law and shall be subject to the general terms and conditions of NautaDutilh. Any liability arising out of or in connection with this opinion letter shall be limited to the amount which is paid out under NautaDutilh's insurance policy in the matter concerned. No person other than NautaDutilh may be held liable in connection with this opinion letter.
In this opinion letter, legal concepts are expressed in English terms. The Dutch legal concepts concerned may not be identical in meaning to the concepts described by the English terms as they exist under the law of other jurisdictions. In the event of a conflict or inconsistency, the relevant expression shall be deemed to refer only to the Dutch legal concepts described by the English terms.
For the purposes of this opinion letter, we have assumed that:
| a. | drafts of documents reviewed by us will be signed in the form of those drafts, each copy of a document conforms to the original, each original is authentic, and each signature is the genuine signature of the individual purported to have placed that signature; |
| b. | if any signature under any document is an electronic signature (as opposed to a handwritten ("wet ink") signature) only, the method used for signing is sufficiently reliable; |
| c. | each of the Deed of Incorporation and the Deed of Conversion is a valid notarial deed; |
| d. | the Registration Statement has been declared effective by the SEC in the form reviewed by us; |
| e. | at each Relevant Moment, (i) Ordinary Shares shall have been admitted for trading on a trading system outside the European Economic Area comparable to a regulated market or a multilateral trading facility as referred to in Section 2:86c(1) DCC and (ii) no financial instruments issued by the Company (or depository receipts for or otherwise representing such financial instruments) have been admitted to trading on a regulated market, multilateral trading facility or organised trading facility operating in the European Economic Area (and no request for admission of any such financial instruments to trading on any such trading venue has been made; |
| f. | (i) no internal regulations (reglementen) have been adopted by any |
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corporate body of the Company which would affect the validity of the resolutions recorded in the relevant Resolutions and (ii) the Current Articles are the Articles of Association currently in force and as they will be in force at each Relevant Moment;
| g. | (i) at each Relevant Moment, the resolutions recorded in the Resolutions shall be in full force and effect, (ii) at each Relevant Moment, the factual statements made and the confirmations given in the Resolutions and in each Deed of Issue shall be complete and correct and (iii) the Resolutions correctly reflect the resolutions recorded therein; |
| h. | at each Relevant Moment, the authorised share capital (maatschappelijk kapitaal) of the Company shall allow for the issuance of the Offer Shares and the Option Shares; |
| i. | the Option (i) has been validly granted as a right to subscribe for Ordinary Shares (recht tot het nemen van aandelen), (ii) shall be in full force and effect upon being exercised, and (iii) shall have been validly exercised in accordance with the terms of the Underwriting Agreement prior to the issuance of any Option Shares; |
| j. | at each Relevant Moment, the relevant Deed of Issue shall have been validly signed and executed on behalf of the Company; |
| k. | the Offering, to the extent made in the Netherlands, has been, is and will be made in conformity with the Prospectus Regulation and the rules promulgated thereunder; and |
| l. | at each Relevant Moment, each of the assumptions made in this opinion letter will be correct in all aspects by reference to the facts and circumstances then existing. |
Based upon and subject to the foregoing and subject to the qualifications set forth in this opinion letter and to any matters, documents or events not disclosed to us, we express the following opinions:
Corporate Status
| 1. | The Company has been duly incorporated as a besloten vennootschap met beperkte aansprakelijkheid and is validly existing as a naamloze vennootschap. |
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Offer Shares and Option Shares
| 2. | Subject to receipt by the Company of payment in full for the Offer Shares and the Option Shares as provided for in the Reviewed Documents, and when issued and accepted in accordance with the Resolutions and the Reviewed Documents, the Offer Shares and the Option Shares shall be validly issued, fully paid and non-assessable. |
The opinions expressed above are subject to the following qualifications:
| A. | Opinion 1 must not be read to imply that the Company cannot be dissolved (ontbonden). A company such as the Company may be dissolved, inter alia by the competent court at the request of the company's board of directors, any interested party (belanghebbende) or the public prosecution office in certain circumstances, such as when there are certain defects in the incorporation of the company. Any such dissolution will not have retro-active effect. |
| B. | Pursuant to Section 2:7 DCC, any transaction entered into by a legal entity may be nullified by the legal entity itself or its liquidator in bankruptcy proceedings (curator) if the objects of that entity were transgressed by the transaction and the other party to the transaction knew or should have known this without independent investigation (wist of zonder eigen onderzoek moest weten). The Dutch Supreme Court (Hoge Raad der Nederlanden) has ruled that in determining whether the objects of a legal entity are transgressed, not only the description of the objects in that legal entity's articles of association (statuten) is decisive, but all (relevant) circumstances must be taken into account, in particular whether the interests of the legal entity were served by the transaction. Based on the objects clause contained in the Current Articles, we have no reason to believe that, by entering into the Reviewed Documents, the Company would transgress the description of the objects contained in its Articles of Association. However, we cannot assess whether there are other relevant circumstances that must be taken into account, in particular whether the interests of the Company are served by entering into the Reviewed Documents since this is a matter of fact. |
| C. | Pursuant to Section 2:98c DCC, a company such as the Company may grant loans (leningen verstrekken) only in accordance with the restrictions set out in Section 2:98c DCC, and may not provide security (zekerheid stellen), give a price guarantee (koersgarantie geven) or otherwise bind itself, whether jointly and severally or otherwise with or for third parties |
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(zich op andere wijze sterk maken of zich hoofdelijk of anderszins naast of voor anderen verbinden) with a view to (met het oog op) the subscription or acquisition by third parties of shares in its share capital or depository receipts. This prohibition also applies to its subsidiaries (dochtervennootschappen). It is generally assumed that a transaction entered into in violation of Section 2:98c DCC is null and void (nietig). Based on the content of the Reviewed Documents, we have no reason to believe that the Company or its subsidiaries will violate Section 2:98c DCC in connection with the issue of the Offer Shares or the Option Shares. However, we cannot confirm this definitively, since the determination of whether a company (or a subsidiary) has provided security, has given a price guarantee or has otherwise bound itself, with a view to the subscription or acquisition by third parties of shares in its share capital or depository receipts, as described above, is a matter of fact.
| D. | The opinions expressed in this opinion letter may be limited or affected by: |
| a. | rules relating to Insolvency Proceedings or similar proceedings under a foreign law and other rules affecting creditors' rights generally; |
| b. | the provisions of fraudulent preference and fraudulent conveyance (Actio Pauliana) and similar rights available in other jurisdictions to insolvency practitioners and insolvency office holders in bankruptcy proceedings or creditors; |
| c. | claims based on tort (onrechtmatige daad); |
| d. | sanctions and measures, including but not limited to those concerning export control, pursuant to European Union regulations, under the Dutch Sanctions Act 1977 (Sanctiewet 1977) or other legislation; |
| e. | the Anti-Boycott Regulation, Anti-Money Laundering Laws and related legislation; |
| f. | any intervention, recovery or resolution measure by any regulatory or other authority or governmental body in relation to financial enterprises or their affiliated entities; and |
| g. | the rules of force majeure (niet toerekenbare tekortkoming), reasonableness and fairness (redelijkheid en billijkheid), suspension (opschorting), dissolution (ontbinding), unforeseen |
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circumstances (onvoorziene omstandigheden) and vitiated consent (i.e., duress (bedreiging), fraud (bedrog), abuse of circumstances (misbruik van omstandigheden) and error (dwaling)) or a difference of intention (wil) and declaration (verklaring).
| E. | The term "non-assessable" has no equivalent in the Dutch language and for purposes of this opinion letter such term should be interpreted to mean that a holder of an Ordinary Share shall not by reason of merely being such a holder be subject to assessment or calls by the Company or its creditors for further payment on such Ordinary Share. |
| F. | This opinion letter does not purport to express any opinion or view on the operational rules and procedures of any clearing or settlement system or agency. |
We consent to the filing of this opinion letter as an exhibit to the Registration Statement and also consent to the reference to NautaDutilh in the Registration Statement and the Prospectus Supplement under the caption "Legal Matters". In giving this consent we do not admit or imply that we are a person whose consent is required under Section 7 of the United States Securities Act of 1933, as amended, or any rules and regulations promulgated thereunder.
Sincerely yours,
/s/ NautaDutilh N.V.
NautaDutilh N.V.
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EXHIBIT A
LIST OF DEFINITIONS
|
"Anti-Money Laundering Laws"
|
The European Anti-Money Laundering Directives, as implemented in the Netherlands in the Money Laundering and Terrorist Financing Prevention Act (Wet ter voorkoming van witwassen en financieren van terrorisme) and the Dutch Criminal Code (Wetboek van Strafrecht). |
| "Anti-Boycott Regulation" | Regulation (EC) No 2271/96 on protecting against the effects of the extra-territorial application of legislation adopted by a third country, and actions based thereon or resulting therefrom. |
| "Articles of Association" | The Company's articles of association (statuten) as they read from time to time. |
| "Board" | The Company's board of directors (bestuur). |
| "Commercial Register" | The Dutch Commercial Register (handelsregister). |
| "Company" | Immatics N.V., a public company with limited liability (naamloze vennootschap), registered with the Commercial Register under number 77595726. |
| "Corporate Documents" | The Deed of Incorporation, the Deed of Conversion, the Current Articles, the Resolutions, the Registration Statement and the Prospectus Supplement. |
| "Current Articles" | The Articles of Association as contained in the Deed of Conversion and as they read as of July 1, 2021 pursuant to the transitional provision previously included in the Articles of Association as article 51. |
| "DCC" | The Dutch Civil Code (Burgerlijk Wetboek). |
| "Deed of Conversion" | The deed of conversion and amendment to the |
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| 8 |
| Articles of Association dated July 1, 2020. | |
| "Deed of Incorporation" | The Company's deed of incorporation (akte van oprichting) dated March 10, 2020. |
|
"Deed of Issue"
|
The draft deed of issue of the Offer Shares or Option Shares, as the case may be, prepared by us with references 82045201 M 54284355 and 82045201 M 54284357 respectively. |
| "Dutch Bankruptcy Code" | The Dutch Bankrupcty Code (Faillissementswet). |
| "General Meeting" | The Company's general meeting (algemene vergadering). |
| "Insolvency Proceedings" | Any insolvency proceedings within the meaning of Regulation (EU) 2015/848 on insolvency proceedings (recast), listed in Annex A thereto and any statutory proceedings for the restructuring of debts (akkoordprocedure) pursuant to the Dutch Bankruptcy Code. |
| "NautaDutilh" | NautaDutilh N.V. |
| "the Netherlands" | The European territory of the Kingdom of the Netherlands and "Dutch" is in or from the Netherlands. |
| "Offer Shares" | 15,925,000 Ordinary Shares. |
| "Offering" | The offering of Ordinary Shares as contemplated by the Prospectus Supplement. |
| "Option" |
The option to acquire Option Shares granted to the Underwriters pursuant to the Underwriting Agreement and the Resolutions. |
| "Option Shares" |
Up to 2,388,750 Ordinary Shares or such lesser number of Ordinary Shares in respect of which the Option is exercised. |
| "Ordinary Shares" | Ordinary shares in the Company's capital, with a |
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| nominal value of EUR 0.01 each. | |
| "Prospectus Regulation" | Regulation (EU) 2017/1129 on the prospectus to be published when securities are offered to the public or admitted to trading on a regulated market. |
| "Prospectus Supplement" |
The prospectus supplement to the Registration Statement filed or to be filed with the SEC in the form reviewed by us. |
| "Registration Statement" | The Company's registration statement on Form F-3 under the U.S. Securities Act of 1933, as amended, as filed by the Company with the SEC and effective on August 9, 2021. |
| "Relevant Moment" | Each time when Offer Shares or Option Shares are issued pursuant to the execution of a Deed of Issue. |
| "Resolutions" |
Each of the following:
a. the written resolutions of the General Meeting, dated June 30, 2020;
b. the written resolution of the Board, dated January 14, 2024; and
c. the written resolution of the pricing committee established by the Board, dated January 17, 2024. |
| "Reviewed Documents" | Each Deed of Issue and the Underwriting Agreement. |
| "SEC" | The United States Securities and Exchange Commission. |
| "Underwriters" | The Underwriters, as defined in the Underwriting Agreement. |
| "Underwriting Agreement" | The underwriting agreement between the Company and the Underwriters in connection with the Offering, dated January 17, 2024. |
Exhibit 99.1
P R E S S R E L E A S E
Immatics Announces Proposed Public Offering
Houston, Texas and Tuebingen, Germany, January 17, 2024 – Immatics N.V. (NASDAQ: IMTX, “Immatics”), a clinical-stage biopharmaceutical company active in the discovery and development of T cell-redirecting cancer immunotherapies, announced today the commencement of an underwritten public offering of its ordinary shares. The offering is subject to market conditions and other factors, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.
Jefferies, BofA Securities and Leerink Partners are acting as joint book-running managers for the offering.
A registration statement relating to the securities has been filed with the U.S. Securities and Exchange Commission (the “SEC”) and was declared effective on August 9, 2021. The offering will be made only by means of a prospectus supplement and accompanying prospectus. A preliminary prospectus supplement related to the offering has been filed with the SEC and is available free of charge by visiting EDGAR on the SEC’s website at www.sec.gov. Copies of the preliminary prospectus supplement and the accompanying prospectus relating to the offering may be obtained free of charge from
| · | Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022, telephone: (877) 821-7388, email: Prospectus_Department@Jefferies.com; |
| · | BofA Securities, Attention: Prospectus Department, NC1-022-02-25, 201 North Tryon Street, Charlotte, NC 28255-0001, telephone: (800) 294-1322, email: dg.prospectus_requests@bofa.com; |
| · | Leerink Partners LLC, Attention: Syndicate Department, 53 State Street, 40th Floor, Boston, MA 02109, telephone: (800) 808-7525, ext. 6105, email: syndicate@leerink.com. |
This press release shall not constitute an offer to sell or a solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction. Any offers, solicitations or offers to buy, or any sales of securities will be made in accordance with the registration requirements of the Securities Act of 1933, as amended.
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| Immatics Press Release, January 17, 2024 | 1 | 2 |
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About Immatics
Immatics combines the discovery of true targets for cancer immunotherapies with the development of the right T cell receptors with the goal of enabling a robust and specific T cell response against these targets. This deep know-how is the foundation for our pipeline of Adoptive Cell Therapies and TCR Bispecifics as well as our partnerships with global leaders in the pharmaceutical industry. We are committed to delivering the power of T cells and to unlocking new avenues for patients in their fight against cancer.
Forward-Looking Statements
Certain statements in this press release may be considered forward-looking statements, including statements regarding the proposed securities offering. Such forward-looking statements are subject to risks, uncertainties, and other factors which could cause actual results to differ materially from those expressed or implied by such forward-looking statements. These forward-looking statements are based upon estimates and assumptions that, while considered reasonable by Immatics and its management, are inherently uncertain. New risks and uncertainties may emerge from time to time, and it is not possible to predict all risks and uncertainties. Factors that may cause actual results to differ materially from current expectations include, but are not limited to, various factors beyond management's control including general economic conditions and other risks, uncertainties and factors set forth in filings with the SEC. Nothing in this press release should be regarded as a representation by any person that the forward-looking statements set forth herein will be achieved or that any of the contemplated results of such forward-looking statements will be achieved. You should not place undue reliance on forward-looking statements, which speak only as of the date they are made. Immatics undertakes no duty to update these forward-looking statements.
For more information, please contact:
| Media |
| Trophic Communications |
| Phone: +49 171 3512733 |
| immatics@trophic.eu |
| Investor Relations | |
| Sabrina Schecher, Ph.D. | |
| Senior Director, Investor Relations | |
| Phone: +49 89 262002433 | |
| InvestorRelations@immatics.com |
| Immatics Press Release, January 17, 2024 | 2 | 2 |
Exhibit 99.2
P R E S S R E L E A S E
Immatics Announces Pricing of $175 Million Public Offering
Houston, Texas and Tuebingen, Germany, January 17, 2024 – Immatics N.V. (NASDAQ: IMTX, “Immatics”), a clinical-stage biopharmaceutical company active in the discovery and development of T cell-redirecting cancer immunotherapies, announced today the pricing of an underwritten public offering of 15,925,000 ordinary shares at a public offering price of $11.00 per share. The gross proceeds from the offering, before deducting the underwriting discount and offering expenses, are expected to be approximately $175 million. The offering is expected to close on January 22, 2024, subject to customary closing conditions. In addition, Immatics has granted the underwriters a 30-day option to purchase up to 2,388,750 additional shares at the public offering price, less the underwriting discount.
Jefferies, BofA Securities and Leerink Partners are acting as joint book-running managers for the offering.
A registration statement relating to the securities has been filed with the U.S. Securities and Exchange Commission (the “SEC”) and was declared effective on August 9, 2021. The offering is being made only by means of a prospectus supplement and accompanying prospectus. When available, copies of the final prospectus supplement and the accompanying prospectus relating to the offering may be obtained free of charge from
| · | Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022, telephone: (877) 821-7388, email: Prospectus_Department@Jefferies.com; |
| · | BofA Securities, Attention: Prospectus Department, NC1-022-02-25, 201 North Tryon Street, Charlotte, NC 28255-0001, telephone: (800) 294-1322, email: dg.prospectus_requests@bofa.com; |
| · | Leerink Partners LLC, Attention: Syndicate Department, 53 State Street, 40th Floor, Boston, MA 02109, telephone: (800) 808-7525, ext. 6105, email: syndicate@leerink.com. |
This press release shall not constitute an offer to sell or a solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction. Any offers, solicitations or offers to buy, or any sales of securities will be made in accordance with the registration requirements of the Securities Act of 1933, as amended.
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| Immatics Press Release, January 17, 2024 | 1 | 2 |
| |
About Immatics
Immatics combines the discovery of true targets for cancer immunotherapies with the development of the right T cell receptors with the goal of enabling a robust and specific T cell response against these targets. This deep know-how is the foundation for our pipeline of Adoptive Cell Therapies and TCR Bispecifics as well as our partnerships with global leaders in the pharmaceutical industry. We are committed to delivering the power of T cells and to unlocking new avenues for patients in their fight against cancer.
Forward-Looking Statements
Certain statements in this press release may be considered forward-looking statements, including statements regarding the securities offering. Such forward-looking statements are subject to risks, uncertainties, and other factors which could cause actual results to differ materially from those expressed or implied by such forward-looking statements. These forward-looking statements are based upon estimates and assumptions that, while considered reasonable by Immatics and its management, are inherently uncertain. New risks and uncertainties may emerge from time to time, and it is not possible to predict all risks and uncertainties. Factors that may cause actual results to differ materially from current expectations include, but are not limited to, various factors beyond management's control including general economic conditions and other risks, uncertainties and factors set forth in filings with the SEC. Nothing in this press release should be regarded as a representation by any person that the forward-looking statements set forth herein will be achieved or that any of the contemplated results of such forward-looking statements will be achieved. You should not place undue reliance on forward-looking statements, which speak only as of the date they are made. Immatics undertakes no duty to update these forward-looking statements.
For more information, please contact:
| Media |
| Trophic Communications |
| Phone: +49 171 3512733 |
| immatics@trophic.eu |
| Investor Relations | |
| Sabrina Schecher, Ph.D. | |
| Senior Director, Investor Relations | |
| Phone: +49 89 262002433 | |
| InvestorRelations@immatics.com |
| Immatics Press Release, January 17, 2024 | 2 | 2 |
Exhibit 99.3
© Immatics. Not for further reproduction or distribution. Delivering the Power of T cells to Cancer Patients © Immatics. Not for further reproduction or distribution. Immatics Corporate Presentation January 22, 2024
Forward - Looking Statement This presentation (“Presentation”) is provided by Immatics N . V . (“Immatics” or the “Company”) for informational purposes only . The information contained herein does not purport to be all - inclusive and none of Immatics, any of its affiliates, any of its or their respective control persons, officers, directors, employees or representatives makes any representation or warranty, express or implied, as to the accuracy, completeness or reliability of the information contained in this Presentation . Forward - Looking Statements . Certain statements in this presentation may be considered forward - looking statements . Forward - looking statements generally relate to future events or the Company’s future financial or operating performance . For example, statements concerning timing of data read - outs for product candidates, the timing and outcome of clinical trials, the nature of clinical trials (including whether such clinical trials will be registration - enabling), the timing of IND or CTA filing for pre - clinical stage product candidates, estimated market opportunities of product candidates, the Company’s focus on partnerships to advance its strategy, and other metrics are forward - looking statements . In some cases, you can identify forward - looking statements by terminology such as “may”, “should”, “expect”, “plan”, “target”, “intend”, “will”, “estimate”, “anticipate”, “believe”, “predict”, “potential” or “continue”, or the negatives of these terms or variations of them or similar terminology . Such forward - looking statements are subject to risks, uncertainties, and other factors which could cause actual results to differ materially from those expressed or implied by such forward looking statements . These forward - looking statements are based upon estimates and assumptions that, while considered reasonable, Immatics and its management, are inherently uncertain . New risks and uncertainties may emerge from time to time, and it is not possible to predict all risks and uncertainties . Factors that may cause actual results to differ materially from current expectations include, but are not limited to, various factors beyond management's control including general economic conditions and other risks, uncertainties and factors set forth in the Company’s Annual report on Form 20 - F and other filings with the Securities and Exchange Commission (SEC) . Nothing in this presentation should be regarded as a representation by any person that the forward - looking statements set forth herein will be achieved or that any of the contemplated results of such forward - looking statements will be achieved . You should not place undue reliance on forward - looking statements, which speak only as of the date they are made . The Company undertakes no duty to update these forward - looking statements . No Offer or Solicitation . This communication is for informational purposes only and does not constitute, or form a part of, an offer to sell or the solicitation of an offer to sell or an offer to buy or the solicitation of an offer to buy any securities, and there shall be no sale of securities, in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction . No offer of securities shall be made except by means of a prospectus meeting the requirements of Section 10 of the Securities Act of 1933 , as amended, or in an offering exempt from registration . Certain information contained in this Presentation relates to or is based on studies, publications, surveys and the Company’s own internal estimates and research . In addition, all of the market data included in this presentation involves a number of assumptions and limitations, and there can be no guarantee as to the accuracy or reliability of such assumptions . Finally, while the Company believes its internal research is reliable, such research has not been verified by any independent source . All the scientific and clinical data presented within this presentation are – by definition prior to completion of the clinical trial and a clinical study report – preliminary in nature and subject to further quality checks including customary source data verification . 2
Therapeutic Opportunity Potential for addressing large patient populations with high prevalence targets in solid tumors Two Clinical - Stage Modalities Pipeline of TCR - T and TCR Bispecific product candidates in clinical & preclinical development Building a Leading TCR Therapeutics Company 3 Intro Differentiated Platforms Unique technologies to identify true cancer targets and right TCRs Clinical PoC for Cell Therapy Anti - tumor activity and durability of response across multiple solid tumors in early TCR - T clinical development
Upcoming 2024 Catalysts for ACTengine® and TCER® Clinical Lead Assets Projected Cash Runway into 2027 to Reach Multiple Value Inflections Points 4 IMA203 GEN1 • Update on clinical development plan in 1Q 2024 • Targeted registration - enabling Phase 2 trial for ACTengine® IMA203 GEN1 in melanoma IMA203CD8 GEN2 • Interim data update with longer follow - up planned ACTengine® IMA203 / IMA203CD8 (PRAME) First clinical data update from dose escalation in ongoing Phase 1 trial planned TCER® IMA401 (MAGEA4/8) First clinical data update from dose escalation in ongoing Phase 1/2 trial planned Initial focus indications: Ovarian cancer, uterine cancer, lung cancer, melanoma and others TCER® IMA402 (PRAME) Updates planned across the entire clinical portfolio throughout 2024 Intro
Our TCR - based Approaches Leverage the Full Target Space beyond the Cancer Cell Surface 5 Intro
Two Distinct TCR - based Therapeutic Modalities in Clinical Development 6 Differentiated positioning of ACTengine® vs. TCER® based on patient population and medical need Intro 1 Interim data update from the ACTengine® IMA203/IMA203CD8 monotherapies (published November 08, 2023); 2 Initial manufacturing may provide sufficient quantity for potential repeat dosing. Autologous TCR - T (ACTengine®) TCR Bispecifics (TCER®) • Strong clinical activity in patients with high tumor burden 1 • Single dose 2 • Proprietary manufacturing process for enhanced potency of T cells • Specialized medical centers • Target requirements: stringent tumor selectivity, low, medium, high copy numbers • Off - the - shelf biologic for immediate treatment • Repeat dosing • All hospitals and out - patient, opportunity for larger patient reach • Favorable commercial characteristics • Target requirements: strong tumor association, median to high copy numbers
Modality Product Candidate Target Preclinical Phase 1a 1 Phase 1b 1 Phase 2 Phase 3 Autologous ACT ACTengine® IMA203 PRAME ACTengine® IMA203CD8 PRAME ACTengine® IMA204 COL6A3 Multiple programs Undisclosed Allogeneic ACT γδ T cells ACTallo® IMA30x Undisclosed Multiple programs Undisclosed Bispecifics TCER® IMA401 MAGEA4/8 TCER® IMA402 PRAME TCER® IMA40x Undisclosed TCER® program Undisclosed Multiple programs 3 Undisclosed Our Pipeline of TCR - based Adoptive Cell Therapies and Bispecifics 7 Intro 1 Phase 1a: Dose escalation, Phase 1b: Dose expansion ; 2 I mmatics ’ proprietary ACTallo® platform utilizing Editas’ CRISPR gene editing technology; 3 mRNA - enabled in vivo expressed TCER® molecules ; IMA203 Cohort B (IMA203 in combination with an immune checkpoint inhibitor) has previously been deprioritized 2
Immatics & Moderna – A Strategic Multi - Platform R&D Collaboration Combining Immatics’ Target and TCR Platforms with Moderna’s mRNA Technology 8 TCER® mRNA Approach Development of mRNA - enabled in vivo expressed half - life extended TCER® molecules targeting cancer - specific HLA - presented peptides Option for global P&L sharing for most advanced TCER® program TCR - T + mRNA Vaccine Combo mRNA Cancer Vaccines Development of mRNA cancer vaccines by leveraging Moderna’s mRNA technology and Immatics’ target discovery platform XPRESIDENT® and bioinformatics and AI platform XCUBE Ρ Economics • $ 120 million upfront cash payment plus research funding • >$1.7 billion potential development, regulatory & commercial milestones • Potential for tiered royalties on global net sales of TCER® products and certain cancer vaccine products commercialized under the agreement Evaluation of Immatics’ IMA203 TCR - T therapy targeting PRAME in combination with Moderna’s PRAME mRNA - based cancer vaccine 1 Within the collaboration, preclinical activities conducted by Immatics will be managed by the Immatics Discovery Unit, a rece ntl y created internal division at Immatics integrating its technology platforms into one interdisciplinary team focused on all early - stage preclinical pipeline and collaboration programs.; 1 Each Party will retain full ownership of its investigational compound Intro
Strategic Collaborations Synergistic Expertise that Can Foster Transformative Innovations across Various Modalities Research collaboration to develop bispecific immunotherapies $54 M upfront, up to $550 M aggregated milestone payments per program, up to double - digit tiered royalties; Co - promotion option Research collaboration to develop autologous TCR - T therapies $75 M (2019) + $20 M (2022) upfront , up to $505 M aggregated milestone payments per program, tiered royalties; Co - development/Co - fund option; Opt - in right for 1 st program exercised by BMS in 2Q 2023 for $15 M option exercise fee Research collaboration to develop off - the - shelf allogeneic γδ - based TCR - T/ CAR - T programs $60 M upfront up to $700 M milestone payments per program, low double - digit tiered royalties Clinical co - development collaboration to develop Immatics’ TCR Bispecific program TCER® IMA401 $150 M upfront , up to $770 M aggregated milestone payments, double - digit tiered royalties; Co - promotion option in the US 2022 2021 2018 2019 9 Intro 2023 Multi - platform R&D collaboration t o develop in vivo expressed TCER® molecules, mRNA cancer vaccines and combo of TCR - T + mRNA vaccine $120 M upfront , >$1.7 B potential aggregated milestone payments, tiered royalties; Option for global P&L sharing for most advanced TCER®
Potential for Large Patient Populations across Multiple Solid Cancers 10 Uterine Carcinoma – 97 % Uterine Carcinosarcoma – 100% Sarcoma Subtypes – up to 100% Cut. Melanoma ≥ 95% Uveal Melanoma 1 ≥ 91% Ovarian Carcinoma – 84% Squamous NSCLC – 68% TNBC – 63% Small Cell Lung Cancer – 45% Kidney Carcinoma – up to 40% Cholangiocarcinoma – 33% HNSCC – 27% Esophageal Carcinoma – 27% Breast Carcinoma – 26% Adeno NSCLC – 25% HCC – 18 % Bladder Carcinoma – 18% Squamous NSCLC – 52% Sarcoma Subtypes – up to 60% HNSCC – 36% Bladder Carcinoma – 29 % Uterine Carcinosarcoma – 29% Esophageal Carcinoma – 23% Ovarian Carcinoma – 23% Melanoma – 18 % I MA203 / IMA402 PRAME IMA401 MAGEA4/8 IMA204 COL6A3 Exon 6 Intro ACTengine® and TCER® targets demonstrate high prevalence in m ultiple s olid cancers Target prevalence for selected solid cancer indications are based on TCGA (for SCLC: in - house) RNAseq data combined with a propr ietary mass spec - guided RNA expression threshold ; 1 Uveal melanoma target prevalence is based on IMADetect® qPCR testing of screening biopsies from clinical trial patients (n=33 ) Pancreatic Carcinoma – 76% Breast Carcinoma – 77% Stomach Carcinoma – 67% Sarcoma – 63% Colorectal Carcinoma – 60% Esophageal Carcinoma – 60% Squamous NSCLC – 55% Adeno NSCLC – 57% HNSCC – 56% Uterine Carcinosarcoma – 50% Mesothelioma – 44% Cholangiocarcinoma – 36% Melanoma – 35% Bladder Carcinoma – 34% Ovarian Carcinoma – 31%
Realizing the Full Multi - Cancer Opportunity of PRAME ACTengine® IMA203 (TCR - T) and TCER® IMA402 (TCR Bispecific) 11 ACTengine® IMA203 (TCR - T) Cancer Cell Death PRAME is one of the most promising and most prevalent, clinically validated solid tumor targets known to date Leverage the full potential of targeting PRAME by continued evaluation of the best suited therapeutic modality (ACTengine® vs. TCER® or both) for each cancer type Intro Phase 1b dose expansion ongoing TCER® IMA402 (TCR Bispecific) 1 PRAME target prevalence is based on TCGA (for SCLC: in - house) RNAseq data combined with a proprietary mass spec - guided RNA expre ssion threshold; 2 Uveal melanoma target prevalence is based on IMADetect® qPCR testing of screening biopsies from clinical trial patients (n=33); NSCLC: Non - small cell lung cancer, TNBC: Triple - negative breast cancer, HNSCC: Head and neck squamous cell carcinoma; HCC: Hepatocellular carcinoma Indication % PRAME positive patients 1 Uterine Carcinoma Uterine Carcinosarcoma Sarcoma Subtypes Cut. Melanoma Uveal Melanoma 2 Ovarian Carcinoma Squamous NSCLC TNBC Small Cell Lung Cancer Kidney Carcinoma Cholangiocarcinoma HNSCC Esophageal Carcinoma Breast Carcinoma Adeno NSCLC HCC Bladder Carcinoma 97% 100% up to 100% ≥ 95% ≥ 91% 84% 68% 63% 45% up to 40% 33% 27% 27% 26% 25% 18% 18% Dose escalation of Phase 1/2 trial ongoing
ACTengine® IMA203 – TCR - T Targeting PRAME 12
The Multi - Cancer Opportunity of PRAME One of the Most Promising Solid Tumor Targets for TCR - based Therapies Known To Date 13 High prevalence High target density Homogeneous expression “Clean” expression profile Clinical proof - of - concept s qNSCLC Ovarian Cancer PRAME fulfills all properties of an ideal target for TCR - based therapies PRAME RNA detection in tumor samples (ISH) ISH: in situ hybridization, sqNSCLC : squamous n on - small cell lung cancer IMA203 78025&(// 7&(// ,> Ͳ Ύ ϬϮ ͗ Ϭϭ WZD d Z WZD W Ğ Ɖ ƟĚĞ
ACTengine® IMA203 Targeting PRAME – Mechanism of Action Immatics’ Leading TCR - T Approach 14 IMA203
ACTengine® IMA203/IMA203CD8 TCR - T Monotherapy – Patient Flow 15 HLA - A*02 Testing Blood sample; Central lab Treatment & Observation Phase Long Term Follow - up Screening & Manufacturing Phase Manufacturing by Immatics Infusion of ACTengine® IMA203 TCR - T Product Lymphodepletion * Target Profiling IMADetect® Biopsy or archived tissue Low dose IL - 2 ** Safety and efficacy monitoring for 12 months Leukapheresis x x Expression Antigen 1 3 2 Short process time of 14 days * 30 mg/m 2 Flu darabine and 500 mg/m 2 Cy clophosphamide for 4 days; ** 1m IU daily days 1 - 5 and twice daily days 6 - 10 7 - day manufacturing process applying CD8/CD4 T cell selection 7 - day QC release testing Cut. Melanoma Uveal Melanoma Uterine Carcinoma Ovarian Carcinoma 95% (58/61) 91% (30/33) 89% (8/9) 82% (23/28) Patient screening data from Immatics’ clinical trials: IMA203
IMA203 GEN1 – Melanoma as First Indication for Pivotal Development 16 * Patients with at least one post treatment tumor response assessment Patient characteristics All comers Cohort A Melanoma pts Ph1a & Cohort A at RP2D Ovarian cancer pts Ph1a & Cohort A at RP2D Efficacy population* 18 13 4 Prior lines of treatment Median (min, max) 3 (0, 10) 4 (0, 7) 4.5 (3, 10) LDH at baseline >1 x ULN [% of patients] 50.0 53.9 100.0 Baseline tumor burden Target lesion sum of diameter [mm] (median, min, max) 58.9 (21.0, 207.3) 52.0 (21.0, 178.7) 108.8 (50.6, 207.3) Patient Numbers* ALL Melanoma Ovarian Cancer Synovial Sarcoma H&N Cancer Others Phase 1a RP2D 7 5 0 0 0 2 Cohort A RP2D 18 8 4 3 1 2 All 8 cut. melanoma patients were CPI - refractory and 5 of 8 were BRAF - inhibitor pretreated • Sub - group analysis per tumor type at target dose includes data from Phase 1a plus Cohort A at RP2D • Melanoma patient number (N=13) and characteristics allow such sub - group analysis for initial assessment of anti - tumor activity • For other tumor types, appropriate patient numbers and characteristics have not yet been achieved All ovarian cancer patients were platinum - resistant Data cut - off Sep 30, 2023 IMA203
ACTengine® IMA203 / IMA203CD8 TCR - T Monotherapy Two Assets with Distinct Opportunities and Near - Term Catalysts 17 GEN1: IMA203 in Melanoma at RP2D GEN2: IMA203CD8 in Solid Tumors Initial Clinical Data • Complete dose escalation • Signal finding in non - melanoma indications, such as ovarian cancer, uterine cancer, NSCLC, triple - negative breast cancer and others Development Path Clinical Data Cell Product Manufacturing • 7 - day manufacturing process, plus 7 - day release testing • RP2D defined at 1 - 10x10 9 total TCR - T cells • Manufacturing success rate: >95% • Well tolerated • 50% (6/12) confirmed objective response rate ( cORR ) • Durability with ongoing responses at 15+ months; mDOR not reached at mFU of 14.4 months • Manageable tolerability • 56% (5/9) confirmed objective response rate ( cORR ) • Durable response at 12+ months; mDOR not reached at mFU of 4.8 months • 6 out of 7 responses ongoing at data cut - off • Enhanced pharmacology with differentiated response pattern Development Path • FDA RMAT designation for multiple PRAME+ cancers including cutaneous & uveal melanoma • IMA203 GEN1 in melanoma targeted to enter registration - enabling Phase 2 trial in 2024 • Update on clinical development plan in 1Q 2024 mDOR : median Duration of Response; mFU : median Follow - up ; RP2D: Recommended Phase 2 Dose Data cut - off Sep 30, 2023 IMA203
ACTengine® IMA203 / IMA203CD8 TCR - T Trial in Advanced Solid Tumors Overview D ose Level 1 - 4 ( total N=27): Patients in DL4 (N=7) treated at RP2D Phase 1b Dose Expansion Phase 1a Dose Escalation Efficacy population shown: patients treated with IMA203 (Cohort A) or IMA203CD8 (Cohort C) and with at least one available tu mor response assessment post infusion; RP2D: Recommended Phase 2 Dose of 1 - 10x10 9 total TCR - T cells; IMA203 DL4: 0.2 - 1.2x10 9 TCR - T cells/m 2 BSA, IMA203 DL5: 1.201 x 4.7x10 9 TCR - T cells/m 2 BSA; IMA203CD8 DL3: 0.2 - 0.48x10 9 TCR - T cells/m 2 BSA, IMA203CD8 DL4a: 0.481 - 0.8x10 9 TCR - T cells/m 2 BSA, IMA203CD8 DL4b: 0.801 - 1.2x10 9 TCR - T cells/m 2 Data cut - off Sep 30, 2023 Phase 1a and Cohort A data set in appendix; Cohort B deprioritized GEN1 : IMA203 GEN2 : IMA203CD8 Functional CD8 TCR - T cells only Functional CD8 and CD4 TCR - T cells Today’s update focuses on 13 melanoma patients treated at RP2D with IMA203 GEN1 and 12 all comers patients treated with IMA203CD8 GEN2 Melanoma Patients at RP2D: Total N=13 (5 Ph1a + 8 Cohort A) Cohort C (N=12): Dose Level 3/4a/4b Dose escalation ongoing Cohort A (total N=18) : Dose Level 4/5 All patients treated at RP2D 18 IMA203
Overview of Patient Characteristics and Responses 19 * Patients with at least one available tumor response assessment post infusion; # All patients were PD at data cut - off; Initial ORR: Objective response rate according to RECIST 1.1 at any post infusion scan; Confirmed ORR ( cORR ): Confirmed objective response rate according to RECIST 1.1 for patients with at least two available post infusion scans or patients with progressi ve disease (PD) at any prior timepoint, patients with ongoing unconfirmed PR not included in cORR calculation; Duration of response (DOR) in confirmed responders is defined as time from first documented response until disease progression/death. Pat ien ts with ongoing response will be censored at date of data cut - off. Median DOR is analyzed by using the Kaplan - Meier method; Median Follow - up is analyzed by using the reverse Kaplan - Meier method; DOR: Duration of Response; FU: Follow - up IMA203 GEN1 IMA203CD8 GEN2 All Comers (N=45) Melanoma Subgroup (N=13 of 45) All Comers (N=12) Phase 1a Cohort A Phase 1a + Cohort A Cohort C Efficacy population* N=27 Thereof N=7 at RP2D N=18 at RP2D N=13 at RP2D N=12 Prior lines of systemic treatment ( median, min, max) 4 (1, 8) 3 (0, 10) 4 (0, 7) 3 (1, 5) LDH at baseline >1 x ULN [% of patients] 66.7 50.0 53.8 50.0 Baseline tumor burden Median target lesion sum of diameter [mm] (min, max) 133.0 (29, 219.7) 58.9 (21, 207.3) 52.0 (21.0, 178.7) 79.8 (20.0, 182.0) Dose level DL1 - 4 DL4/5 DL4/5 DL3/DL4a/DL4b ORR 48% (13/27) 50% (9/18) 62% (8/13) 58% (7/12) cORR 19% (5/27) 47% (8/17) 50% (6/12) 56% (5/9) mDOR [months] 4.4 (2.4, 23.0) Not reached Not reached Not reached mFU [months] Not defined # 10.8 14.4 4.8 Data cut - off Sep 30, 2023 Heavily Pretreated Patient Population across Clinical Trial Cohorts IMA203
ACTengine® IMA203 TCR - T Interim Update Delivering a Meaningful Benefit to Patients with an Unmet Medical Need 20 IMA203 GEN1 Monotherapy Phase 1a & Cohort A – Focus on Melanoma at RP2D IMA203CD8 GEN2 Monotherapy Cohort C – First Data Set on 2 nd Generation Summary & Next Development Steps IMA203
21 Data cut - off Sep 30, 2023 IMA203 GEN1 in All Melanoma Patients at RP2D – Most Frequent Adverse Events • Expected cytopenia (Grade 1 - 4) associated with lymphodepletion in all patients • Mostly mild to moderate cytokine release syndrome (CRS) • 63% (10/16) with Grade 1 CRS • 31% (5/16) with Grade 2 CRS • 6% (1/16) with Grade 3 CRS (Phase 1a patient; recovered to Grade 2 after 3 days, no need for vasopressors and/or ventilation) • No dose - dependent increase of CRS • O ne non - serious, mild (Grade 1) ICANS 2 in DL5 • No dose - limiting toxicity • No IMA203 - related deaths • full IMA203 GEN1 monotherapy safety profile (generally consistent with safety in melanoma subset), see next slide 1 Three cutaneous melanoma patients treated with IMA203 and pending post infusion scan included in safety population, but not e ff icacy population; 2 I CANS: Immune Effector Cell - Associated N eurotoxicity S yndrome ; CRS and ICANS graded by CARTOX criteria ( Neelapu et al ., 2018) N=16 Patients in Safety Population 1 IMA203 GEN1 monotherapy continues to be well tolerated at total doses between 1 - 10x10 9 TCR - T cells (RP2D) IMA203
Adverse event ( System organ class , Preferred term ) ≥ Grade 3 No . % Patients with any adverse event 49 100.0 Adverse Events of Special Interest 2 4.1 Cytokine release syndrome 2 4.1 ICANS 2 0 0.0 Blood and lymphatic system disorders 48 98.0 Neutropenia 36 73.5 Lymphopenia 27 55.1 Leukopenia 26 53.1 Anaemia 24 49.0 Thrombocytopenia 17 34.7 Cytopenia 1 2.0 Leukocytosis 1 2.0 Lymphocytosis 1 2.0 Investigations 9 18.4 Neutrophil count decreased 4 8.2 Alanine aminotransferase increased 2 4.1 Aspartate aminotransferase increased 2 4.1 White blood cell count decreased 2 4.1 Blood alkaline phosphatase increased 1 2.0 Blood creatinine increased 1 2.0 Blood fibrinogen decreased 1 2.0 Infections and infestations 7 14.3 Appendicitis 1 2.0 COVID - 19 1 2.0 Enterococcal infection 1 2.0 Infection 1 2.0 Orchitis 1 2.0 Sepsis 4,5 1 2.0 Septic shock 4 1 2.0 Urinary tract infection 1 2.0 Respiratory, thoracic and mediastinal disorders 6 12.2 Hypoxia 3 6.1 Bronchial obstruction 1 2.0 Laryngeal inflammation 1 2.0 Pleural effusion 1 2.0 Respiratory failure 1 2.0 Vascular disorders 6 12.2 Hypertension 4 8.2 Hypotension 2 4.1 Adverse event ( System organ class , Preferred term ) ≥ Grade 3 No . % table continued… General disorders and administration site conditions 4 8.2 Condition aggravated 4 1 2.0 Fatigue 1 2.0 Pyrexia 1 2.0 Swelling face 1 2.0 Metabolism and nutrition disorders 4 8.2 Hypokalaemia 3 6.1 Failure to thrive 1 2.0 Hypophosphataemia 1 2.0 Gastrointestinal disorders 2 4.1 Abdominal pain 1 2.0 Diarrhoea 1 2.0 Vomiting 1 2.0 Injury, poisoning and procedural complications 2 4.1 Humerus fracture 1 2.0 Infusion related reaction 1 2.0 Renal and urinary disorders 2 4.1 Acute kidney injury 1 2.0 Proteinuria 1 2.0 Skin and subcutaneous tissue disorders 2 4.1 Rash maculo - papular 2 4.1 Cardiac disorders 1 2.0 Atrial fibrillation 3 1 2.0 Endocrine disorders 1 2.0 Inappropriate antidiuretic hormone secretion 1 2.0 Eye disorders 1 2.0 Ulcerative keratitis 1 2.0 Hepatobiliary disorders 1 2.0 Cholangitis 1 2.0 Immune system disorders 1 2.0 Contrast media allergy 1 2.0 Musculoskeletal and connective tissue disorders 1 2.0 Muscle spasms 1 2.0 Nervous system disorders 1 2.0 Headache 1 2.0 Reproductive system and breast disorders 1 2.0 Vaginal haemorrhage 1 2.0 IMA203 GEN1 across All Dose Levels – Tolerability Data Phase 1a Dose Escalation and Cohort A – All ≥Grade 3 Adverse Events (N=49) 22 • Well tolerated at doses as high as ~10x10 9 TCR - T cells • No AE ≥Grade 3 was observed with a frequency ≥10% when excluding expected cytopenia associated with lymphodepletion • No IMA203 - related Grade 5 Adverse Events All treatment - emergent adverse events (TEAEs) with ≥ Grade 3 regardless of relatedness to study treatment that occurred in at least 1 patient (except for ICANS, where only Grade 1 - 2 occurred ; listed for completeness due to being an adverse event of special interest) are presented . Adverse events were coded using the Medical Dictionary for Regulatory Activities . Grades were determined according to National Cancer Institute Common Terminology Criteria of Adverse Events, version 5 . 0 . Grades for CRS and ICANS were determined according to CARTOX criteria ( Neelapu et al . , 2018 ) . Patients are counted only once per adverse event and severity classification . Based on interim data extracted from open clinical database ( 30 - Sep - 2023 ) ; 1 Two patients with disease progression after first IMA 203 infusion received exploratory second IMA 203 infusion . They had these ≥ Grade 3 TEAEs only after second infusion, which are included in the table : First patient : Abdominal pain, Cytokine release syndrome, Diarrhoea , Hypokalaemia , Proteinuria ; Second patient : Humerus fracture, Muscle spasms, Neutropenia, Thrombocytopenia ; 2 ICANS : Immune effector cell - associated neurotoxicity syndrome ; 3 DLT : Dose limiting toxicity in phase 1 a at DL 2 reported on March 17 , 2021 ; 4 Fatal Adverse events were not considered related to any study drug ; 5 Patient died from sepsis of unknown origin and did not receive IMA 203 TCR - T cells . TEAEs by maximum severity for all patients in Phase 1a dose escalation and Cohort A dose expansion (N=49) 1 Data cut - off Sep 30, 2023
# # # # # # # # # # IMA203 GEN1 in All Melanoma Patients at RP2D (N=13) – BOR and Response over Time Durable Responses 15+ Months after Treatment 23 Data cut - off Sep 30, 2023 Ongoing ORR 62% (8/13) cORR 50% (6/12) Initial ORR: Objective response rate according to RECIST 1.1 at any post infusion scan; Confirmed ORR ( cORR ): Confirmed objective response rate according to RECIST 1.1 for patients with at least two available post infusion scans or pat ients with progressive disease (PD) at any prior timepoint, patients with ongoing unconfirmed PR not included in cORR calculation; Duration of response (DOR) in confirmed responders is defined as time from first documented response until disease progression/death. Patients with ongoing response will be censored at date of data cut - off. Median DOR is analyzed by using the Kaplan - Meier method; Median Follow - up is analyzed by using the reverse Kaplan - Meier method; PD: Progressive Disease; SD: Stable Disease; PR: Partial Response; cPR : Confirmed Partial Response; BL: Baseline; BOR: Best Overall Response; DOR: Duration of Response; Scans at approximately week 6, month 3 and then every 3 months # Patients in Phase 1a Median DOR, min, max DOR Not reached, 2.2+, 14.7+ months Median Follow - up 14.4 months IMA203
24 High Medical Need in Cutaneous and Uveal Melanoma Clinically and Commercially Attractive Features of IMA203 Cutaneous Melanoma Uveal Melanoma Patient Population 2L+ CPI - refractory, BRAF/MEK inhibitor - refractory if BRAF mutation+ 2L+ Kimmtrak - refractory, CPI/chemotherapy - refractory IMA203 Opportunity ~3,000 HLA - A*02:01 and PRAME - positive cutaneous melanoma patients annually in the US 1 ~300 HLA - A*02:01 and PRAME - positive uveal melanoma patients annually in the US 2 Well tolerated Mostly mild to moderate CRS, infrequent & mild ICANS Promising anti - tumor activity ( cORR , mDOR ) Leukapharesis as source for cell product, no surgery required Short manufacturing time of 7 days plus 7 days of QC release testing Low dose IL - 2 post IMA203 infusion with better tolerability profile than high dose IL - 2 CPI: Checkpoint inhibitor; 1 Based on annual mortality of ~7,700 cutaneous melanoma patients in the US, HLA - A*02:01 prevalence of 41% in the US and PRAME pr evalence of 95% (TCGA RNAseq data combined with proprietary MS - guided RNA expression threshold); 2 Based on annual mortality of ~800 uveal melanoma patients in the US, HLA - A*02:01 prevalence of 41% in the US and PRAME prevalen ce of 91% (IMADetect® qPCR testing of screening biopsies from clinical trial patients (n=33)) ≥95% of cutaneous melanoma patients are PRAME - positive Data cut - off Sep 30, 2023 IMA203 GEN1 in Melanoma Targeted to Enter Registration - Enabling Phase 2 Trial in 2024 IMA203
ACTengine® IMA203 TCR - T Interim Update Delivering a Meaningful Benefit to Patients with an Unmet Medical Need 25 IMA203 GEN1 Monotherapy Phase 1a & Cohort A – Focus on Melanoma at RP2D IMA203CD8 GEN2 Monotherapy Cohort C – First Data Set on 2 nd Generation Summary & Next Development Steps IMA203
IMA203CD8 GEN2 – IMA203 TCR - T Monotherapy Leveraging CD8 and CD4 cells Differentiated Pharmacology Compared to 1 st - Generation TCR - only Approaches • IMA203CD8 GEN2 designed to broaden the clinical potential of IMA203 TCR - T monotherapy by adding functional CD4 T cells via co - transduction of CD8 αβ alongside PRAME TCR • Activated CD4 T cells aid activity of other immune cells by releasing cytokines and acquire cytotoxic functions • Functional CD4 T cells mediate longer anti - tumor activity than CD8 T cells and potentiate the anti - tumor activity of the cell product in preclinical studies 1 • Data from CD19 CAR - T - treated leukaemia patients suggest a relevant role of engineered CD4 T cells in long - term durability 2 TUMOR CELL DEATH CD4 T CELL Cytotoxic Activity CD8 T CELL T cell Help Cytotoxic Activity 26 1 Internal data not shown here, published in Bajwa et al. 2021 Journal for Immunotherapy of Cancer; 2 M elenhorst et al. 2022 Nature , Bai et al. 2022 Science Advances CD8 PRAME TCR IMA203CD8
IMA203CD8 GEN2 – Preclinical Assessment of Anti - Tumor Efficacy Functional CD4 T cells Mediate Longer Anti - Tumor Activity than CD8 T cells in vitro 27 0 50 100 150 200 250 300 350 400 450 0.0 0.5 1.0 1.5 2.0 CD8 Hours after Coculture T u m o r f o l d g r o w t h 0 50 100 150 200 250 300 350 400 450 0.0 0.5 1.0 1.5 2.0 CD4 Hours after Coculture T u m o r f o l d g r o w t h 2 nd addition of tumor cells 3 rd 4 th 5 th 6 th 2 nd addition of tumor cells 3 rd 4 th 5 th 6 th IMA203CD8
IMA203CD8 GEN2 in Cohort C (N=12) – Most Frequent Adverse Events Manageable Tolerability in 12 Patients Treated with IMA203CD8 at 3 Escalating Dose Levels 1 • Expected cytopenia (Grade 1 - 4) associated with lymphodepletion in all patients • Cytokine release syndrome (CRS) in 92% (11/12) of patients: Trend towards more severe CRS at higher doses, in all cases well manageable • 67 % (8/12) with Grade 1 or 2 CRS (4 in DL3, 3 in DL4a, 1 in DL4b) • 17% (2/12) with Grade 3 CRS (2 in DL4b; patient C - DL4b - 04, see also description below) • 8% (1/12) with Grade 4 CRS (1 in DL4b, patient C - DL4b - 01, see also description below ) • One patient with neurotoxicity (see below), no ICANS 2 or neurotoxicity reported for the other patients • Dose - limiting toxicities (DLTs) at Dose Level 4b were observed in 2 of 4 patients 1) In patient C - DL4b - 01 treated with highest possible dose at DL4b, high biological activity ( in vivo T cell expansion) observed; patient developed Grade 4 neurotoxicity and Grade 4 CRS on day 6 after infusion, combined with Grade 3 Hemophagocytic Lymphohistiocytosis (HLH) 2) Patient C - DL4b - 04 treated at DL4b developed Grade 3 CRS with transient Grade 3 liver enzyme (ALT) increase that resolved to Grad e 2 within 10 days; no need for vasopressors or ventilation at any time • No high - grade CRS, no neurotoxicity and no DLTs were reported for 4 patients treated at DL3 and 4 patients treated at DL4a • No IMA203CD8 - related deaths • Expanded DL4a dose cohort ongoing 28 1 N=4 DL3, N=4 DL4a, N=4 DL4b, DL3: 0.2 - 0.48x10 9 TCR - T cells/m 2 BSA, DL4 is split into a DL4a (0.481 - 0.8x10 9 TCR - T cells/m 2 BSA) and DL4b (0.801 - 1.2x10 9 TCR - T cells/m 2 BSA); 2 I CANS: Immune Effector Cell - Associated N eurotoxicity S yndrome ; CRS and ICANS graded by CARTOX criteria ( Neelapu et al ., 2018) IMA203CD8 GEN2 monotherapy shows a manageable tolerability profile Data cut - off Sep 30, 2023 IMA203CD8
Tolerability Data – Cohort C IMA203CD8 GEN2 29 Adverse event ≥ Grade 3 ( System organ class , preferred term) No. % Patients with any adverse event 12 100.0 Adverse events of special interest 3 25.0 Cytokine release syndrome 1 3 25.0 Immune effector cell - associated neurotoxicity syndrome 0 0.0 Blood and lymphatic system disorders 11 91.7 Neutropenia 9 75.0 Anaemia 8 66.7 Lymphopenia 8 66.7 Thrombocytopenia 4 33.3 Leukopenia 2 16.7 Investigations 4 33.3 Aspartate aminotransferase increased 2 16.7 Neutrophil count decreased 2 16.7 Alanine aminotransferase increased 1 8.3 Blood alkaline phosphatase increased 1 8.3 Blood bilirubin increased 1 8.3 Gamma - glutamyltransferase increased 1 8.3 Metabolism and nutrition disorders 2 16.7 Hypermagnesaemia 1 8.3 Hypoalbuminaemia 1 8.3 Hypophosphataemia 1 8.3 Nervous system disorders 2 16.7 Neurotoxicity 2 1 8.3 Syncope 1 8.3 Immune system disorders 1 8.3 Haemophagocytic lymphohistiocytosis 2 1 8.3 Infections and infestations 1 8.3 Infection 1 8.3 All treatment - emergent adverse events (TEAEs) with ≥ Grade 3 regardless of relatedness to study treatment that occurred in at least 1 patient ( except for ICANS, where no event was documented; listed for completeness due to being an adverse event of special interest) are presented. Adverse events were coded using the Medical Dictionary for Regulatory Activities. Grades were determined according to National Cancer Institute Common Terminology Criteria of Adverse Events, version 5.0. Grades for CRS and ICANS were determined according to CARTOX criteria ( Neelapu et al., 2018). Patients are counted only once per adverse event and severity classification. Based on interim data extracted from open clinical database (30 - Sep - 2023) ; 1 DLT: Dose limiting toxicity in patient DL4b - 04. 2 DLTs in patient DL4b - 01; All ≥Grade 3 Adverse Events (N=12) TEAEs by maximum severity for all patients in Cohort C (N= 12 ) • Manageable tolerability • Most frequent ≥Grade 3 AEs were expected cytopenia associated with lymphodepletion • No IMA203CD8 - related Grade 5 Adverse Events • Dose escalation ongoing Data cut - off Sep 30, 2023
IMA203CD8 GEN2 in Cohort C (N=12 # ) – BOR and Response over Time Deepening of Response from SD to PR in 2 Patients, 6 Responses Ongoing 30 • 6 out of 7 responses ongoing • 11/12 patients show tumor shrinkage • Deepening of response from SD to PR in two patients (C - DL4a - 01, C - DL4a - 03) • Ongoing durable response 12+ months after infusion Median DOR, min, max DOR Not reached, 2.0+, 11.5+ months Median Follow - up 4.8 months ORR 58% (7/12) cORR 56% (5/9) Initial ORR: Objective response rate according to RECIST 1.1 at any post infusion scan; Confirmed ORR ( cORR ): Confirmed objective response rate according to RECIST 1.1 for patients with at least two available post infusion scans or pat ients with progressive disease (PD) at any prior timepoint, patients with ongoing unconfirmed PR not included in cORR calculation; Duration of response (DOR) in confirmed responders is defined as time from first documented response until disease progression/death. Patients with ongoing response will be censored at date of data cut - off. Median DOR is analyzed by using the Kaplan - Meier method; Median Follow - up is analyzed by using the reverse Kaplan - Meier method; PD: Progressive Disease; SD: Stable Disease; PR: Partial Response; cPR : Confirmed Partial Response; BL: Baseline; BOR: Best Overall Response; DOR: Duration of Response # Patient C - DL4a - 04 was PD ~6 weeks after infusion, not shown due to non - evaluable target lesions at tumor assessment Scans at approximately week 6, month 3 and then every 3 months Ongoing Data cut - off Sep 30, 2023 * Clinical tumor progress after 4.9 months post infusion, investigator information * IMA203CD8
IMA203CD8 GEN2: Translational Data Shows Enhanced Pharmacology Cohort A IMA203 GEN1 (All Patients at RP2D) vs Cohort C IMA203CD8 GEN2 31 Trend towards responses at lower cell dose and higher tumor burden with IMA203CD8 Higher peak expansion ( C max ) of IMA203CD8 T cells when normalized to infused dose Higher activation levels in IMA203CD8 T cells at week 1… …without exhaustion over time Initial translational data indicates higher biological and clinical activity of IMA203CD8 GEN2 % PD - 1 of specific T cells at week1: for patient A - DL5 - 05 data not available for week 1 0 5×10 5 1×10 6 1.5×10 6 2×10 6 2.5×10 6 V e c t o r c o p i e s / μ g g D N A p=0.0010 PR cPR PD/SD Cohort A IMA203 GEN1 Cohort C IMA203CD8 GEN2 Data cut - off Sep 30, 2023 IMA203CD8
ACTengine® IMA203 TCR - T Interim Update Delivering a Meaningful Benefit to Patients with an Unmet Medical Need 32 IMA203 GEN1 Monotherapy Phase 1a & Cohort A – Focus on Melanoma at RP2D IMA203CD8 GEN2 Monotherapy Cohort C – First Data Set on 2 nd Generation Summary & Next Development Steps IMA203
ACTengine® IMA203 / IMA203CD8 TCR - T Monotherapy Targeting PRAME Summary of GEN1 and GEN2 Clinical Data and Planned Next Steps 33 Next Step Alignment with FDA on patient population, trial design, CMC targeting registration - enabling Phase 2 trial in melanoma • Well tolerated, mostly mild to moderate CRS, infrequent & mild ICANS • 50% (6/12) cORR , mDOR not reached at mFU of 14.4 months • Durability with ongoing responses at 15+ months in some patients • RP2D defined at 1 - 10x10 9 total TCR - T cells • FDA RMAT designation received in multiple PRAME expressing cancers including cutaneous and uveal melanoma • Enhanced primary and secondary pharmacology when compared to GEN1 • Manageable tolerability (2 DLTs at DL4b, dose escalation ongoing) • Initial clinical activity observed with differentiated response pattern • 56% (5/9) cORR • 6 out of 7 responses ongoing at data cut - off, durable response at 12+ months • SD converting to PR over time (N=2) • Enhanced biological efficacy with PRs at lower T cell:tumor cell ratio compared to IMA203 GEN1 IMA203 GEN1 Monotherapy in Melanoma at RP2D IMA203CD8 GEN2 Monotherapy IMA203 GEN1 Monotherapy in Melanoma at RP2D Next Step Complete dose escalation and further dose expansion with focus on non - melanoma patients Data cut - off Sep 30, 2023 IMA203
PRAME mRNA expression in IMA203 GEN1 Phase 1a and Cohort A responders at RP2D (n=13) PRAME mRNA expression in IMA203CD8 GEN2 Cohort C responders (n=7) Potential of IMA203 in Additional Solid Cancer Indications Based on PRAME Expression in IMA203 GEN1 and IMA203CD8 GEN2 Responders 34 % PRAME - positive patients 1 PRAME target expression distribution (blue histogram) based on TCGA RNAseq data, patient data (black dots) based on IMADetect ® q PCR testing of screening biopsies; 1 PRAME target prevalence is based on TCGA RNAseq data combined with a proprietary MS - guided RNA expression threshold; 2 PRAME target prevalence in uveal melanoma based on IMADetect® qPCR testing of screening biopsies from clinical trial patients ( n=33) demonstrates substantial higher prevalence of 91% compared to prevalence based on TCGA data of 50%, TCGA: early & late - stage primary tumor samples, Immatics clinical trials: late - stage/metastatic tumor samples, Role of PRAME in metastasis of uveal melanoma: Field et al. 2016 Clinical Cancer Research; MS: mass spectrometry Data cut - off Sep 30, 2023 ≥ 95% ≥ 91% (50% 2 ) 97% 100% 84% 68% 63% 27% Immatics’ current MS - guided mRNA threshold for patient selection Selected indications Clinical activity shown No clinical activity expected Potential opportunity to see clinical activity IMA203
ACTengine® IMA203 / IMA203CD8 TCR - T Monotherapy Targeting PRAME Leveraging the Full Breath of PRAME in Three Steps 35 Development Strategy Step 1 IMA203 GEN1 in cutaneous melanoma (potentially bundled with uveal melanoma) as first tumor type targeted to enter registration - enabling trial Signal finding in ovarian cancer and uterine cancer in dedicated dose expansion cohorts, preferentially with IMA203CD8 GEN2 Pursue tumor - agnostic label in PRAME+ solid cancers to leverage full breadth of PRAME - including NSCLC, triple - negative breast cancer and others Step 2 Step 3 2024 2024 IMA203
ACTengine® IMA203 TCR - T Product Manufacturing Enhancing Manufacturing Process and Capabilities Leukapheresis 1 - Week Manufacturing Process 1 - Week QC Release Testing Infusion - ready Manufacturing of ACTengine® IMA203 TCR - T & other future autologous /allogeneic candidates Expected to be operational in 2024 Approx. 100,000 sq ft in Houston area, TX – modular and flexible design Early - stage and registration - directed clinical trials as well as initial commercial supply State - of - the - art research & GMP manufacturing facility Short manufacturing turnaround time 36 IMA203
Selected Indications Incidence R/R Incidence PRAME Positive Patient Population Based on R/R Incidence; PRAME and HLA - A*02:01+ Cut. Melanoma 99,800 7,700 95% 2,999 Uveal Melanoma 1,500 800 91% 298 Ovarian Carcinoma 19,900 12,800 84% 4,408 Uterine Carcinoma 62,700 10,700 97% 4,255 Uterine Carcinosarcoma 3,300 1,900 100% 779 Squamous NSCLC 57,000 34,600 68% 9,646 Small Cell Lung Cancer 31,900 19,400 45% 3 ,579 Adeno NSCLC 91,200 55,300 25% 5,668 HNSCC 66,500 15,100 27% 1,672 Breast Carcinoma 290,600 43,800 26% TNBC: 63% 4,669 Synovial Sarcoma 1,000 400 100% 164 Cholangiocarcinoma 8,000 7,000 33% 9 47 IMA203 TCR - T Has the Potential to Reach a Large Patient Population ~39,000 Patients per Year in the US only 37 Incidences based on public estimates and Immatics internal model; Relapsed/refractory (R/R) or last - line patient population approximated by annual mortality; Estimated 41% HLA - A*02:01 positive population in the US; PRAME target prevalence is based on TCGA (for SCLC: in - house) RNAseq data combined with a proprietary mass spec - guided RNA expression threshold ; Uveal melanoma target prevalence is based on IMADetect® qPCR testing of screening biopsies from clinical trial patients (n= 33) Multiple opportunities to broaden patient reach and patient benefit: » Expand beyond US population » Expand into other indications such as kidney, esophageal, bladder, other liver cancers, other sarcoma subtypes through indication - specific or indication - agonistic label expansion » Move into earlier lines of therapy (R/R Incidence Incidence ) » Inclusion of patients with lower PRAME - threshold TOTAL ~ 39 ,000 annually in the US IMA203
ACTengine® IMA204 – TCR - T Targeting COL6A3 Exon 6 38
ACTengine® IMA204 First - in - Class TCR - T Targeting Tumor Stroma Key Features 39 HLA - A*02 - presented peptide derived from COL6A3 exon 6 Naturally and specifically presented on tumors at high target density 1 : 100 - 700 copies/cell Novel tumor stroma target identified and validated by XPRESIDENT® quant. mass spectrometry platform High - affinity, specific TCR targeting COL6A3 exon 6 Affinity - maturated, CD8 - independent TCR High functional avidity 2 : ~0.01ng/ml Identified and characterized by XCEPTOR® TCR discovery and engineering platform CD8 - independent, next - generation TCR engages both, CD8 and CD4 T cells In vitro anti - tumor activity against target - positive cell lines in CD8 and CD4 T cells Complete tumor eradication in in vivo mouse models Pancreatic Carcinoma – 76% Breast Carcinoma – 77% Stomach Carcinoma – 67% Sarcoma – 63% Colorectal Carcinoma – 60% Esophageal Carcinoma – 60% Squamous NSCLC – 55% Adeno NSCLC – 57% HNSCC – 56% Uterine Carcinosarcoma – 50% Mesothelioma – 44% Cholangiocarcinoma – 36% Melanoma – 35% Bladder Carcinoma – 34% Ovarian Carcinoma – 31% 1 Target density: peptide copy number per tumor cell, approximate range representing the majority of tumor samples analyzed; 2 Functional avidity: EC50 half maximal effective concentration; 3 Solid cancer indications with 20% or more target expression, Target prevalence for selected cancer indications based on mRNA expression (TCGA and Immatics inhouse data) TARGET TCR PREC LINICAL DATA PATIENT POPULATION 3 IMA204 provides a promising therapeutic opportunity for a broad patient population as monotherapy or in combination with TCR - T cells directed against tumor targets IMA204
ACTengine® IMA204 – High Affinity, CD8 - independent TCR Complete Tumor Eradication in vitro & in vivo 1 by Affinity - enhanced IMA204 TCR CD8 - independent TCR leads to tumor eradication in all mice treated 40 Control IMA204 TCR D7 D16 D22 D29 Affinity maturated CD8 - independent, next - generation TCR engages both CD4 and CD8 T cells without the need of CD8 co - transduction Stroma cells Tumor cells Stroma Target (COL6A3 exon 6) in Ovarian Cancer sample Example of a Tumor Target in same Ovarian Cancer sample 1 In vivo data in collaboration with Jim Riley, University of Pennsylvania, control: non - transduced T cells. TCR avidity and specificity d ata not shown, available in IMA204 presentation on Immatics website. COL6A3 exon 6 prevalently expressed at high target density in tumor stroma across many solid cancers IMA204
ACTallo® – Our Next - generation Off - the - shelf TCR - T 41
ACTallo® – Immatics’ Allogeneic Cell Therapy Approach • Off - the - shelf cell therapy , no need for personalized manufacturing reduced logistics and time to application • Potential for hundreds of doses from one single donor leukapheresis lower cost of goods • Use of healthy donor material provides standardized quality and quantity of starting material • Strategic collaborations combining Immatics’ proprietary ACTallo ® platform with Bristol Myers Squibb’s next - gen technologies and Editas Medicine’s CRISPR gene editing technology to develop next - gen allogeneic γδ TCR - T/CAR - T programs 42 ACTallo® γδ T cell Cell Engineering (gene editing & armoring ) γδ T cell Collection from Healthy Donor Expansion Off - the - shelf Products Patient Treatment
Why γδ T cells? γδ T cells Are Well Suited for an Off - the - shelf Cell Therapy Approach 43 γδ T cells x are abundant in the peripheral blood x show intrinsic anti - tumor activity x naturally infiltrate solid tumors & correlate with favorable prognosis x are HLA - independent, thus do not cause graft - vs - host disease in allogeneic setting x can be expanded to high numbers in a cGMP - compatible manner x can be effectively redirected using αβ TCR or CAR constructs In vitro a nti - tumor activity γδ T cells (control) + tumor cells tumor cells only αβ T cells (control) + tumor cells γδ T cells TCR + + tumor cells αβ T cells TCR + + tumor cells ACTallo® 0 5 10 15 20 25 0.001 0.01 0.1 1 10 100 1000 10000 100000 1000000 Day F o l d e x p a n s i o n o f T c e l l s Expansion Fold - growth (target - positive tumor cells)
TCER® – TCR Bispecifics 44
TCER® – Immatics ’ Next - generation, Half - Life Extended Bispecifics Proprietary TCER® Format Consisting of Three Distinct Elements 45 High - affinity TCR domains targeting XPRESIDENT® - selected tumor - specific peptide - HLA molecules Low - affinity T cell recruiter against CD3/TCR Fc part for half - life extension, favorable stability and manufacturability Next - gen, half - life extended TCER® format designed to safely apply high drug doses for activity in a broad range of tumors achieve optimized scheduling 2 1 3 Cytotoxic lytic granules T umor cell killing A ctivated T cell TCER®
TCER® – Immatics’ Next - generation, Half - Life Extended Bispecifics 46 pHLA targeting TCR x High - affinity (single digit nM ) TCR targeting XPRESIDENT® - selected tumor - specific peptide - HLA molecules x Broad therapeutic window through XPRESIDENT® - guided affinity maturation (>1000x) 1 x Complete tumor eradication in mouse xenograft models at low doses T cell recruiting antibody x Low - affinity (triple digit nM ) T cell recruiter against both TCR & CD3 x Optimized biodistribution aiming for enrichment at tumor site and prevention of CRS 2 x Superior anti - tumor activity in mouse models as compared to widely used CD3 recruiters Next - generation TCER® format x Off - the - shelf b iologic with antibody - like manufacturability 3 and low cost of goods x Superior anti - tumor activity 4 compared to six alternative bispecific formats x Half - life of several days expected in humans Our TCER® format is designed to maximize efficacy while minimizing toxicities in patients 1 As compared to natural TCR; 2 Based on literature data for other low - affinity recruiters (e.g. Harber et al ., 2021, Nature; Trinklein et al ., 2019, mAbs ) ; 3 Production in mammalian cells (CHO cells); 4 Based on preclinical testing TCER® 1 2 3
Potency of Our Proprietary TCR Bispecific Format TCER® 47 • Seven different TCR Bispecific formats were evaluated with a pHLA targeting TCR and the identical T cell recruiting antibody • TCER® format had higher combination of potency and specificity 1 than six alternative TCR Bispecific format designs evaluated Flexible Plug - and - play platform: TCER® format successfully validated for different TCRs & different T cell recruiting antibodies TCER® TCER® 2+1 TCR bispecific format: High potency was linked to a significantly reduced specificity profile Killing of target - positive cells by different TCR Bispecifics 1 Preclinical data on specificty not shown
TCER® Format Is Designed for Optimized Efficacy and Safety Superior Tumor Control Using a Novel, Low - Affinity Recruiter 48 Widely used T cell recruiting Ab (3 variants) medium to high affinity (single to double digit nM ) n = 6 mice/treatment group, n = 10 mice in vehicle group, 2 donors/group Dose: 0.025 mg/kg Proprietary, low - affinity T cell recruiting region demonstrates superior tumor control compared to analogous TCER® molecules designed with higher - affinity variants of a widely used recruiter Immatics’ T cell recruiting Ab low affinity (triple digit nM ) TCER® Tumor Model in Mice 1 1 Hs695T xenograft model in NOG m ice , tumor volume of group means shown
TCER® Format Is Designed for Optimized Efficacy and Safety Reduced Target - Unrelated Recruiter - Mediated Cytokine Release using a Low - Affinity Recruiter 49 TCER® Whole blood cytokine release assay N= 3 HLA - A*02 - positive donors N=16 cytokines tested, 4 exemplary cytokines shown
Our TCER® Portfolio Broad Pipeline of Next - Gen Half - Life Extended TCR Bispecifics 50 TCER® • PRAME peptide presented by HLA - A*02:01 • Start of clinical trial in Aug 2023, first clinical data expected 2024 IMA402 Potential for addressing different indications and large patient populations with novel, off - the - shelf TCR Bispecifics • MAGEA4/8 peptide presented by HLA - A*02:01 • Dose escalation ongoing, first clinical data expected 2024 IMA401 • Undisclosed peptides presented by HLA - A*02:01 and other HLA - types • TCER® engineering and preclinical testing ongoing IMA40x Several innovative programs CLINICAL PRECLINICAL
TCER® IMA401 Targeting MAGEA4/8 Homogeneous Expression, Broad Prevalence and High Copy Number Target 51 MAGEA4 RNA detection in tumor samples (ISH) Indications Target p revalence [%] Squamous non - small cell lung carcinoma 52% Head and neck squamous cell carcinoma 36% Bladder carcinoma 29% Uterine carcinosarcoma 29% Esophageal carcinoma 23% Ovarian carcincoma 23% Melanoma 18% plus several further indications MAGEA4/8 target prevalence in selected cancer indications MAGEA4/8 target prevalences are based on TCGA data combined with a XPRESIDENT® - determined target individual MS - based mRNA expression threshold; 1 Copy number per tumor cell (CpC) measured on a paired - sample basis by AbsQuant®, i.e. comparing MAGEA4 vs. MAGEA4/A8 peptide presentation on same sample, 2 Students paired T test IMA401 p<0.001 2 MAGEA4/8 target is presented at >5 - fold higher target density 1 than a commonly used MAGEA4 target peptide
TCER® IMA401 (MAGEA4/8) – Assessment of Anti - Tumor Activity in vitro Patient - Derived Tumor Model 52 NSCLC adenocarcinoma : • M ale, Caucasian, age 58, no therapy prior to surgery • Site of origin: lung, differentiation poor • Date of surgery: 1987, Freiburg Medical Center • Volume doubling time: 7.3 day • Histology: • Stroma content, 4% • Vascularization, high • Grading, undifferentiated • TCER® IMA401 shows high anti - tumor activity in Patient - derived xenograft model of non - small cell lung adenocarcinoma • Remission observed in all mice (3 out of 4 mice with complete remission) LXFA 1012 Tumor Xenograft Model in NOG Mice IMA401
53 TCER® IMA401 (MAGEA4/8) – Pharmacokinetics PK Analysis in NOG Mice • Two different PK assays established to ensure functional integrity of protein domains • Terminal half - life in mice: 10 - 11 days pHLA – V L Assay Fc – V L Assay IMA401
Phase 1 Clinical Trial to Evaluate TCER® IMA401 Targeting MAGEA4/8 54 MTD: maximum tolerated dose, RP2D: recommended phase 2 dose; BLRM: Bayesian logistic regression model; 1 P harmacokinetics data assessed throughout the trial might provide an opportunity to optimize scheduling to a less frequent regimen. 2 Conducted in collaboration with BMS Phase 1a: Dose Escalation Phase 1b: Dose Expansion • Weekly i.v. infusions 1 • Dose escalation decisions based on cohorts of 1 - 6 patients in adaptive design (BLRM model) MTD/ RP2D Adaptive design aimed at accelerating dose escalation • Focus on specific indications planned Potential development option for checkpoint inhibitor combination or other combination therapies 2 Monotherapy expansion cohort Primary Objective • Determine MTD and/or RP2D Secondary Objectives • Safety and tolerability • Initial anti - tumor activity • Pharmacokinetics IMA401
TCER® IMA402 Targeting PRAME – Efficacy Assessment in vitro Tumor Cell Killing at Low Physiological PRAME Peptide Levels 55 0 20 40 60 80 100 120 140 10 -1 10 0 10 1 10 2 10 3 10 4 10 5 IMA402 [pM] Cytotoxicity [%] ~50 PRAME CpCs 0 0 20 40 60 80 100 120 140 10 -1 10 0 10 1 10 2 10 3 10 4 10 5 IMA402 [pM] Cytotoxicity [%] Target-negative 0 0 20 40 60 80 100 120 140 10 -1 10 0 10 1 10 2 10 3 10 4 10 5 IMA402 [pM] Cytotoxicity [%] ~110 PRAME CpCs 0 0 20 40 60 80 100 120 140 10 -1 10 0 10 1 10 2 10 3 10 4 10 5 IMA402 [pM] Cytotoxicity [%] ~250 PRAME CpCs 0 • TCER® IMA402 induces killing of tumor cells with PRAME target copies as low as 50 CpCs • Physiological PRAME levels detected in majority of cancer tissues from patients are 100 – 1000 CpCs • Preclinical activity profile enables targeting of a broad variety of tumor indications, such as lung cancer, breast cancer, ovarian cancer, uterine cancer, melanoma and others IMA402 CpC: Target peptide copy numbers per tumor cell
TCER® IMA402 Achieves Durable Tumor Control of Large Tumors in vivo 56 -29 0 500 1000 1500 2000 2500 0 10 20 30 40 50 60 70 Study day M e d i a n t u m o r v o l u m e [ m m 3 ] Vehicle IMA402 [0.01 mg/kg] IMA402 [0.05 mg/kg] IMA402 [0.25 mg/kg] • Dose - dependent efficacy of IMA402 in cell line - derived in vivo mouse model • Durable shrinkage of large tumors including complete responses over prolonged period • Sufficiently high drug doses are key to achieving desired anti - tumor effect IMA402
Half - life Extended Format of IMA402 Confers Terminal Half - life of >1 Week 57 pHLA – aV L Assay pHLA – aFc Assay • IMA402 shows a terminal serum half - life of ≈ 8 days in mice • IMA402 will be initially dosed weekly in the clinical trial • Dosing frequency may be adapted based on clinical data IMA402
Phase 1/2 Clinical Trial to Evaluate TCER® IMA402 Targeting PRAME First Clinical Data Planned in 2024 58 Phase 1: Dose Escalation Phase 2a: Dose Expansion Adaptive design aimed at accelerating dose escalation • Specific indications plus ongoing basket • Combination therapies • Optional dose/application optimization Expansion cohort Expansion cohort Expansion cohort Trial Overview Phase 1/2 clinical trial to evaluate safety, tolerability and anti - tumor activity of IMA402 • HLA - A*02:01 - positive patients with PRAME - expressing recurrent and/or refractory solid tumors • Initially weekly i.v. infusions • Potential for early adjustment of treatment interval based on PK data of half - life extended TCER® format MTD/ RP2D IMA402 • Basket trial in focus indications to accelerate signal finding • Ovarian cancer, lung cancer, uterine cancer, melanoma, others MTD: maximum tolerated dose, RP2D: recommended phase 2 dose;
Immatics’ Proprietary Target and TCR Discovery Platforms 59
True Cancer Targets & Matching Right TCRs Goal to Maximize Anti - Tumor Activity and Minimize Safety Risks of TCR - based Immunotherapies 60 True Targets via XPRESIDENT® technology platform • are naturally presented on tumor tissues as identified by mass - spec • are absent or presented at only low levels on normal tissues • are presented at high copy numbers to trigger a pharmacological response + Technology Right TCRs via XCEPTOR® technology platform • recognize the target peptide with high affinity and specificity • show selective killing of tumor cells • are developed to be suitable for two different therapeutic modalities, Cell Therapies and TCR Bispecifics
Technology Pool of 200 Prioritized Targets as Foundation for Future Value Generation XPRESIDENT® Target Platform 61 200 Prioritized Targets Grouped in 3 Target Classes: 1. Well known and characterized parent protein (20%) e.g. MAGE family cancer testis antigens 2. Unknown or poorly characterized parent protein (60%) e.g. stroma target COL6A3 exon 6 3. Crypto - targets/Neoantigens (20%) Novel target class which includes RNA - edited peptides & non - classical neoantigens ~50% of our prioritized targets are non - HLA - A*02 restricted, substantially broadening the potential patient reach >2,500 cancer & normal tissues a nalyzed by Quantitative, Ultra - Sensitive Mass Spectrometry pHLA Database based on primary tissues >200 prioritized targets This large data set is leveraged by our bioinformatics & AI - platform XCUBE Ρ – „AI is where the data is ®“
Immatics ’ Unique Capability – Identification of the most Relevant Target Example of MAGEA4/8 Peptide Target 62 1 Copy number per tumor cell (CpC) measured on a paired - sample basis by AbsQuant®, i.e. comparing MAGEA4 vs. MAGEA4/A8 peptide pre sentation on same sample, 2 Students paired T test p<0.001 2 Technology MAGEA4/8 target is presented at >5 - fold higher target density 1 than a commonly targeted MAGEA4 target peptide XPRESIDENT® quantitative information on target density 1 between peptides originating from the same source protein Ranking of pHLA targets Commonly targeted
Development of the Right TCR – XCEPTOR® Technology TCR Discovery and Engineering for ACT and TCR Bispecifics 63 TCR Bispecifics T cell engaging receptor (TCER®) Adoptive Cell Therapy ACTengine® ACTallo ® • Fast, efficient and highly sensitive discovery of highly specific, natural TCRs • Protein engineering capabilities to design and maturate TCRs with increased affinity while retaining specificity • Early de - selection of cross - reactive TCRs by the u nique interplay between Immatics’ target and TCR discovery platforms XPRESIDENT® and XCEPTOR® during TCR discovery 1 and TCR maturation 2 (empowered by our bioinformatics & AI - platform XCUBE Ρ ) Micromolar affinity Nanomolar affinity Technology 1 XPRESIDENT® - guided off - target toxicity screening; 2 XPRESIDENT® - guided similar peptide counterselection
Optimal Target Selection & TCR Specificity for Minimizing Safety Risks Unique Interplay between Technology Platforms Allows Early De - risking for Clinical Development 64 Target peptide presented on tumor cells Selective killing of tumor cells Target peptide presented on normal cells Off - target toxicity On - target (off - tumor) toxicity A different HLA is recognized on normal cells Alloreactivity Similar peptide presented on normal cells 1 XPRESIDENT® - guided screening for on - and off - target toxicities of TCRs based on the extensive database of peptides presented on normal tissues Technology 1 Clinical fatalities have occurred in TCR - T trials using a titin cross - reactive TCR (Cameron et al ., Sci Transl Med)
“AI Is Where the Data Is®” Bioinformatics and AI - Platform XCUBE Ρ 65 Data Engineering Development of data warehouses & user interfaces Data Science Development of statistical & machine learning models Data Processing Processing of mass - spec & next - gen sequencing data 1 THERAPEUTIC KNOWLEDGE XPRESIDENT®/ XCEPTOR® DATA Data Engineering Data Science Data Processing 2 3 1 Cell therapies Bispecifics CDx Therapies Targets Lead Molecules Discovery Characterization Discovery Selection Validation 2 3
Robust IP Portfolio Immatics’ Patent Estate – Territorial Coverage 66 Cancer targets, TCRs and technology protected by: • 5,800 applications and patents filed in all major countries and regions • >115 patent families • >2,400 granted patents, thereof >550 granted patents in the US Technology
Corporate Information & Milestones 67
David Leitner Schuldirektor David Leitner Schuldirektor David Leitner Schuldirektor Harpreet Singh Chief Executive Officer Co - Founder >20 yrs biotech experience Arnd Christ Chief Financial Officer >20 yrs biotech experience ( InflaRx , Medigene , NovImmune , Probiodrug ) Carsten Reinhardt Chief Development Officer >20 yrs pharma & biotech experience ( Micromet , Roche, Fresenius) Cedrik Britten Chief Medical Officer 15 yrs pharma & biotech experience (GSK, BioNTech) Rainer Kramer Chief Business Officer 25 yrs pharma & biotech experience (Amgen, MorphoSys , Jerini , Shire, Signature Dx) Steffen Walter Chief Operating Officer Co - Founder Immatics US >15 yrs biotech experience Edward Sturchio General Counsel >15 yrs pharma & biotech experience ( Abeona Therapeutics, AAA, Novartis, Merck, Schering) ) Jordan Silverstein Head of Strategy >10 yrs biotech experience ( InflaRx , AAA) Toni Weinschenk Chief Innovation Officer Co - Founder >15 yrs biotech experience Experienced Global Leadership Team Across Europe and the US Corporate
Strong, Focused and Highly Integrated Trans - Atlantic Organization 69 Houston, Texas ~ 150 FTEs Cell therapy development & manufacturing Munich, Germany ~ 65 FTEs Various operating functions Tübingen, Germany ~ 215 FTEs Target & TCR discovery and TCR Bispecifics developme nt Corporate FTE status as of December 2022
Delivering s the Power of T cells to Cancer Patients © Immatics. Not for further reproduction or distribution. www.immatics.com Appendix
IMA203 GEN1 in Phase 1a Dose Escalation (N=27 # ) – BOR and Response over Time 71 * Maximum change of target lesions and RECIST 1.1 BOR at different timepoints ; # Synovial sarcoma patient (DL3) PD at week 6 not shown as t arget lesions were not evaluable; PD: Progressive disease; SD: Stable disease; PR: Partial response; cPR : Confirmed partial response; BL: Baseline Best overall response (RECIST1.1) Data cut - off Sep 30, 2023 IMA203 GEN1
* IMA203 GEN1 in Cohort A (N=18) – BOR and Response over Time Objective Responses across Multiple Solid Cancer T ypes 72 1 Patient received one dose nivolumab erroneously; 2 Progressive disease at month 6 due to unequivocal progression of non - target lesions, target lesions not evaluable due to externa l assessment ; Initial ORR: Objective response rate according to RECIST 1.1 at any post infusion scan; Confirmed ORR ( cORR ): Confirmed objective response rate according to RECIST 1.1 for patients with at least two available post infusion scans or pat ients with progressive disease (PD) at any prior timepoint, patients with ongoing unconfirmed PR not included in cORR calculation; Duration of response (DOR) in confirmed responders is defined as time from first documented response until disease progressio n/d eath. Patients with ongoing response will be censored at date of data cut - off. Median DOR is analyzed by using the Kaplan - Meier method; Median Follow - up is analyzed by using the reverse Kaplan - Meier method; PD: Progressive Disease; SD: Stable Disease; PR: Partial Response; cPR : Confirmed Partial Response; BL: Baseline; BOR: Best Overall Response; DOR: Duration of Response Data cut - off Sep 30, 2023 Median DOR, min, max DOR Not reached, 2.2+, 14.7+ months Median Follow - up 10.8 months Scans at approximately week 6, month 3 and then every 3 months Ongoing ORR 50% (9/18) cORR 47% (8/17) * Response until 5.7 months post infusion, target lesion response assessment not available (external assessment) IMA203 GEN1
73 Data cut - off Sep 30, 2023 IMA203 GEN1 in Cohort A – Most Frequent Adverse Events N=21 Patients in Safety Population 1 • Expected cytopenia (Grade 1 - 4) associated with lymphodepletion in all patients • Mild - moderate cytokine release syndrome (CRS) in 90% (19/21) of patients • 43% (9/21) with Grade 1 CRS • 48% (10/21) with Grade 2 CRS • No dose - dependent increase of CRS • O ne non - serious, mild (Grade 1) ICANS 2 in DL5 • No dose - limiting toxicity • No IMA203 - related deaths 1 Three cutaneous melanoma patients treated with IMA203, and pending post infusion scan included in safety population, but not ef ficacy population; 2 I CANS: Immune Effector Cell - Associated N eurotoxicity S yndrome ; CRS and ICANS graded by CARTOX criteria ( Neelapu et al ., 2018) IMA203 GEN1 monotherapy continues to be well tolerated at total doses between 1 - 10x10 9 TCR - T cells (RP2D) IMA203 GEN1
IMA203 GEN1 at RP2D – Tolerability Data Phase 1a DL4 and Cohort A – All ≥Grade 3 Adverse Events (N=28) 74 • IMA203 was well tolerated at doses as high as ~10x10 9 TCR - T cells • Most frequent ≥Grade 3 AEs were expected cytopenia associated with lymphodepletion • No IMA203 - related Grade 5 AEs All treatment - emergent adverse events (TEAEs) with ≥ Grade 3 regardless of relatedness to study treatment that occurred in at least 1 patient (except for ICANS, where only Grade 1 - 2 occurred ; listed for completeness due to being an adverse event of special interest) are presented . Adverse events were coded using the Medical Dictionary for Regulatory Activities . Grades were determined according to National Cancer Institute Common Terminology Criteria of Adverse Events, version 5 . 0 . Grades for CRS and ICANS were determined according to CARTOX criteria ( Neelapu et al . , 2018 ) . Patients are counted only once per adverse event and severity classification . Based on interim data extracted from open clinical database ( 30 - Sep - 2023 ) ; 1 One patient in Phase 1 a DL 4 with disease progression after first IMA 203 infusion received exploratory second IMA 203 infusion and had these ≥ Grade 3 TEAEs only after second infusion, which are included in the table : Humerus fracture, Muscle spasms, Neutropenia, Thrombocytopenia ; 2 ICANS : Immune effector cell - associated neurotoxicity syndrome ; 3 Fatal Adverse events were not considered related to any study drug Adverse event ( System organ class , Preferred term ) ≥ Grade 3 No . % Patients with any adverse event 28 100.0 Adverse Events of Special Interest 1 3.6 Cytokine release syndrome 1 3.6 ICANS 2 0 0.0 Blood and lymphatic system disorders 27 96.4 Neutropenia 18 64.3 Anaemia 14 50.0 Leukopenia 13 46.4 Lymphopenia 11 39.3 Thrombocytopenia 9 32.1 Leukocytosis 1 3.6 Lymphocytosis 1 3.6 Investigations 7 25.0 Neutrophil count decreased 4 14.3 Alanine aminotransferase increased 2 7.1 Aspartate aminotransferase increased 2 7.1 White blood cell count decreased 2 7.1 Blood alkaline phosphatase increased 1 3.6 Infections and infestations 3 10.7 Infection 1 3.6 Septic shock 3 1 3.6 Urinary tract infection 1 3.6 Respiratory, thoracic and mediastinal disorders 3 10.7 Hypoxia 2 7.1 Laryngeal inflammation 1 3.6 Vascular disorders 3 10.7 Hypotension 2 7.1 Hypertension 1 3.6 Metabolism and nutrition disorders 2 7.1 Failure to thrive 1 3.6 Hypokalaemia 1 3.6 Hypophosphataemia 1 3.6 Eye disorders 1 3.6 Ulcerative keratitis 1 3.6 Adverse event ( System organ class , Preferred term ) ≥ Grade 3 No . % table continued… General disorders and administration site conditions 1 3.6 Pyrexia 1 3.6 Hepatobiliary disorders 1 3.6 Cholangitis 1 3.6 Injury, poisoning and procedural complications 1 3.6 Humerus fracture 1 3.6 Musculoskeletal and connective tissue disorders 1 3.6 Muscle spasms 1 3.6 Nervous system disorders 1 3.6 Headache 1 3.6 Skin and subcutaneous tissue disorders 1 3.6 Rash maculo - papular 1 3.6 TEAEs by maximum severity for all patients in Ph1a dose escalation DL4 and Ph1b Cohort A dose expansion ( RP2D, N=28) 1 Data cut - off Sep 30, 2023 IMA203 GEN1
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