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
of the Securities Exchange Act of 1934
May 14, 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 Form 20-F or Form 40-F.
Form 20-F ☒ Form
40-F ☐
INFORMATION CONTAINED IN THIS REPORT ON FORM 6-K
On May 14, 2024, Immatics N.V. (the Company) issued an interim report for the three-month period ended March 31, 2024, which is
attached hereto as Exhibit 99.1, and issued a press release announcing the first quarter 2024 financial results for the Company, which is attached hereto as Exhibit 99.2. In addition, the Company made available an updated investor presentation. A
copy of the presentation is attached hereto as Exhibit 99.3. The fact that the presentation is being made available and furnished herewith is not an admission as to the materiality of any information contained in the presentation. The information
contained in the presentation is being provided as of May 14, 2024 and the Company does not undertake any obligation to update the presentation in the future or to update forward-looking statements to reflect subsequent actual results.
INCORPORATION BY REFERENCE
This Report
on Form 6-K (other than Exhibit 99.2 and Exhibit 99.3 hereto) including Exhibit 99.1 hereto, shall be deemed to be incorporated by reference into the registration statements on Form S-8 (Registration Nos. 333-249408 and 333-265820) and the registration statements on Form F-3
(Registration Nos. 333-258351, 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report is filed, to the extent not superseded by documents or reports subsequently filed or furnished.
EXHIBITS
2
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.
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IMMATICS N.V. |
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Date: May 14, 2024 |
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by: |
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/s/ Harpreet Singh |
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Harpreet Singh |
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Chief Executive Officer |
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Exhibit 99.1
PRELIMINARY NOTE
The unaudited
interim condensed Consolidated Financial Statements for the three-month period ended March 31, 2024, included herein, have been prepared in accordance with International Accounting Standard 34 (Interim Financial Reporting), as
issued by the International Accounting Standards Board (IASB). The Consolidated Financial Statements are presented in euros. All references in this interim report to $, and U.S. dollars mean U.S. dollars and all
references to and euros mean euros, unless otherwise noted.
This interim report, including Managements
Discussion and Analysis of Financial Condition and Results of Operations, contains statements that constitute forward-looking statements within the meaning of Section 21E of the Exchange Act and Section 27A of the Securities Act of
1933, as amended (the Securities Act). All statements other than statements of historical facts, including statements regarding our future results of operations and financial position, business and commercial strategy, potential market
opportunities, products and product candidates, research pipeline, ongoing and planned preclinical studies and clinical trials, regulatory submissions and approvals, research and development costs, timing and likelihood of success, as well as plans
and objectives of management for future operations are forward-looking statements. Many of the forward-looking statements contained in this interim report can be identified by the use of forward-looking words such as anticipate,
believe, could, expect, should, plan, intend, estimate, will and potential among others. Forward-looking statements are based on our
managements beliefs and assumptions and on information available to our management at the time such statements are made. Such statements are subject to risks and uncertainties, and actual results may differ materially from those expressed or
implied in the forward-looking statements due to various factors, including, but not limited to the macro-economic environment; inconclusive clinical trial results or clinical trials failing to achieve one or more endpoints, early data not being
repeated in ongoing or future clinical trials, failures to secure required regulatory approvals, disruptions from failures by third-parties on whom we rely in connection with our clinical trials, delays or negative determinations by regulatory
authorities, changes or increases in oversight and regulation; increased competition; manufacturing delays or problems, inability to achieve enrollment targets, disagreements with our collaboration partners or failures of collaboration partners to
pursue product candidates, legal challenges, including product liability claims or intellectual property disputes, commercialization factors, including regulatory approval and pricing determinations, disruptions to access to raw materials or
starting material, proliferation and continuous evolution of new technologies; disruptions to Immatics business; management changes; dislocations in the capital markets; and other important factors described under Risk Factors in
our Annual Report on Form 20-F for the year ended December 31, 2023, filed with the Securities and Exchange Commission on March 21, 2024 and those described in our other filings with the Securities
and Exchange Commission. Forward-looking statements speak only as of the date on which they were made. Because forward-looking statements are inherently subject to risks and uncertainties, some of which cannot be predicted or quantified and some of
which are beyond our control, you should not rely on these forward-looking statements as predictions of future events. Moreover, we operate in an evolving environment. New risk factors and uncertainties may emerge from time to time, and it is not
possible for management to predict all risk factors and uncertainties. Except as required by applicable law, we do not plan to publicly update or revise any forward-looking statements, whether as a result of any new information, future events,
changed circumstances or otherwise.
We own various trademark registrations and applications, and unregistered trademarks, including Immatics®, XPRESIDENT®, ACTengine®,
ACTallo®, ACTolog®, XCEPTOR®, TCER®, AbsQuant®, IMADetect® and our corporate logo. All other trade names,
trademarks and service marks of other companies appearing in this interim report are the property of their respective owners. Solely for convenience, the trademarks and trade names in this interim report may be referred to without the ® and symbols, but such references should not be construed as any indicator that their respective owners will not assert, to the
fullest extent under applicable law, their rights thereto. We do not intend to use or display other companies trademarks and trade names to imply a relationship with, or endorsement or sponsorship of us by, any other companies.
As used in this interim report, the terms Immatics, we, our, us, the Group and the
Company refer to Immatics N.V. and its subsidiaries, taken as a whole, unless the context otherwise requires. The unaudited interim condensed consolidated financial statements and Managements Discussion & Analysis of Financial
Condition and Results of Operations in this interim report are related to Immatics N.V. and its German subsidiary Immatics Biotechnologies GmbH as well as its U.S. subsidiary Immatics US Inc.
Unaudited Interim Condensed Consolidated Statement of Loss of Immatics N.V.
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Three months ended March 31, |
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Notes |
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2024 |
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2023 |
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(Euros in thousands, except
per share data) |
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Revenue from collaboration agreements |
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5 |
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30,269 |
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9,796 |
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Research and development expenses |
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(32,108 |
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(27,581 |
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General and administrative expenses |
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(11,642 |
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(9,586 |
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Other income |
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12 |
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941 |
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Operating result |
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(13,469 |
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(26,430 |
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Change in fair value of liabilities for warrants |
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6 |
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1,043 |
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7,397 |
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Other financial income |
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6 |
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11,381 |
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2,795 |
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Other financial expenses |
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6 |
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(677 |
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(3,509 |
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Financial result |
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11,747 |
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6,683 |
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Loss before taxes |
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(1,722 |
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(19,747 |
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Taxes on income |
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7 |
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(1,332 |
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Net loss |
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(3,054 |
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(19,747 |
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Net loss per share: |
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17 |
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Basic |
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(0.03 |
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(0.26 |
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Diluted |
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(0.04 |
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(0.26 |
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The accompanying notes are an integral part of these unaudited interim condensed consolidated financial
statements.
Unaudited Interim Condensed Consolidated Statement of Comprehensive Loss of Immatics N.V.
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Three months ended March 31, |
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Notes |
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2024 |
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2023 |
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(Euros in thousands) |
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Net loss |
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(3,054 |
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(19,747 |
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Other comprehensive income |
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Items that may be reclassified subsequently to profit or loss |
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Currency translation differences from foreign operations |
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14 |
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336 |
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564 |
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Total comprehensive loss for the year |
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(2,718 |
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(19,183 |
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The accompanying notes are an integral part of these unaudited interim condensed consolidated financial
statements.
Unaudited Interim Condensed Consolidated Statement of Financial Position of Immatics N.V.
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As of |
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Notes |
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March 31, 2024 |
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December 31, 2023 |
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(Euros in thousands) |
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Assets |
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Current assets |
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Cash and cash equivalents |
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16 |
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122,093 |
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218,472 |
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Other financial assets |
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16 |
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441,857 |
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207,423 |
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Accounts receivables |
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16 |
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1,781 |
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4,093 |
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Other current assets |
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9 |
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22,666 |
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19,382 |
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Total current assets |
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588,397 |
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449,370 |
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Non-current assets |
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Property, plant and equipment |
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10 |
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49,968 |
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43,747 |
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Intangible assets |
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10 |
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1,501 |
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1,523 |
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Right-of-use
assets |
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10 |
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11,886 |
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13,308 |
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Other non-current assets |
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9 |
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1,373 |
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2,017 |
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Total non-current assets |
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64,728 |
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60,595 |
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Total assets |
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653,125 |
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509,965 |
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Liabilities and shareholders equity |
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Current liabilities |
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Provisions |
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11 |
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1,740 |
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Accounts payables |
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12 |
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20,537 |
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25,206 |
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Deferred revenue |
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5 |
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96,525 |
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100,401 |
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Liabilities for warrants |
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16 |
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17,950 |
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18,993 |
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Lease liabilities |
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16 |
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2,762 |
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2,604 |
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Other current liabilities |
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13 |
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9,590 |
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9,348 |
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Total current liabilities |
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149,104 |
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156,552 |
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Non-current liabilities |
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Deferred revenue |
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5 |
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91,358 |
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|
115,527 |
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Lease liabilities |
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|
16 |
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11,877 |
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|
|
12,798 |
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Other non-current liabilities |
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4 |
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Total non-current liabilities |
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103,235 |
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128,329 |
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Shareholders equity |
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Share capital |
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|
14 |
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1,031 |
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|
|
847 |
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Share premium |
|
|
14 |
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|
1,001,402 |
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|
|
823,166 |
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Accumulated deficit |
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|
14 |
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|
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(600,347 |
) |
|
|
(597,293 |
) |
Other reserves |
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|
14 |
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(1,300 |
) |
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(1,636 |
) |
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Total shareholders equity |
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400,786 |
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|
225,084 |
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Total liabilities and shareholders equity |
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653,125 |
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509,965 |
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The accompanying notes are an integral part of these unaudited interim condensed consolidated financial
statements.
Unaudited Interim Condensed Consolidated Statement of Cash Flows of Immatics N.V.
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Three months ended March 31, |
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2024 |
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2023 |
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(Euros in thousands) |
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Cash flows from operating activities |
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Net loss |
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(3,054 |
) |
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(19,747 |
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Taxes on income |
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1,332 |
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Loss before tax |
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(1,722 |
) |
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(19,747 |
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Adjustments for: |
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Interest income |
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(6,294 |
) |
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|
(2,254 |
) |
Depreciation and amortization |
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3,014 |
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1,811 |
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Interest expenses |
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|
194 |
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|
195 |
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Equity-settled share-based payment |
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4,297 |
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|
6,103 |
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Net foreign exchange differences and expected credit losses |
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(4,553 |
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|
3,143 |
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Change in fair value of liabilities for warrants |
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(1,043 |
) |
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|
(7,397 |
) |
Changes in: |
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Decrease in accounts receivables |
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2,312 |
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|
880 |
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Decrease in other assets |
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|
574 |
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|
234 |
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(Decrease) in deferred revenue, accounts payables and other liabilities |
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(31,674 |
) |
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|
(7,793 |
) |
Interest received |
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|
2,484 |
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|
|
1,189 |
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Interest paid |
|
|
(194 |
) |
|
|
(79 |
) |
Income tax paid |
|
|
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|
|
|
|
|
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|
|
|
|
|
|
|
|
Net cash used in operating activities |
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|
(32,605 |
) |
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|
(23,715 |
) |
|
|
|
|
|
|
|
|
|
Cash flows from investing activities |
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|
|
|
|
|
|
|
Payments for property, plant and equipment |
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|
(9,174 |
) |
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|
(4,317 |
) |
Payments for intangible assets |
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|
(2 |
) |
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|
(8 |
) |
Proceeds from disposal of property, plant and equipment |
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|
|
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|
|
|
Payments for investments classified in other financial assets |
|
|
(290,599 |
) |
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|
(67,735 |
) |
Proceeds from maturity of investments classified in other financial assets |
|
|
57,957 |
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|
|
68,341 |
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|
|
|
|
|
|
|
|
|
Net cash used in investing activities |
|
|
(241,818 |
) |
|
|
(3,719 |
) |
|
|
|
|
|
|
|
|
|
Cash flows from financing activities |
|
|
|
|
|
|
|
|
Proceeds from issuance of shares to equity holders |
|
|
185,669 |
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|
|
|
|
Transaction costs deducted from equity |
|
|
(11,548 |
) |
|
|
|
|
Payments related to lease liabilities |
|
|
524 |
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|
|
(866 |
) |
|
|
|
|
|
|
|
|
|
Net cash provided by/(used in) financing activities |
|
|
174,645 |
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|
|
(866 |
) |
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|
|
|
|
|
|
|
|
Net decrease in cash and cash equivalents |
|
|
(99,778 |
) |
|
|
(28,300 |
) |
|
|
|
|
|
|
|
|
|
Cash and cash equivalents at beginning of the year |
|
|
218,472 |
|
|
|
148,519 |
|
|
|
|
|
|
|
|
|
|
Effects of exchange rate changes and expected credit losses on cash and cash equivalents |
|
|
3,399 |
|
|
|
(2,300 |
) |
|
|
|
|
|
|
|
|
|
Cash and cash equivalents at end of the year |
|
|
122,093 |
|
|
|
117,919 |
|
|
|
|
|
|
|
|
|
|
The accompanying notes are an integral part of these unaudited interim condensed consolidated financial
statements.
Unaudited Interim Condensed Consolidated Statement of Changes in Shareholders equity of Immatics
N.V.
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|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(Euros in thousands) |
|
Notes |
|
|
Share capital |
|
|
Share premium |
|
|
Accumulated deficit |
|
|
Other reserves |
|
|
Total share- holders equity |
|
Balance as of January 1, 2023 |
|
|
|
|
|
|
767 |
|
|
|
714,177 |
|
|
|
(500,299 |
) |
|
|
(1,481 |
) |
|
|
213,164 |
|
Other comprehensive income |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
564 |
|
|
|
564 |
|
Net loss |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(19,747 |
) |
|
|
|
|
|
|
(19,747 |
) |
Comprehensive loss for the year |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(19,747 |
) |
|
|
564 |
|
|
|
(19,183 |
) |
Equity-settled share-based compensation |
|
|
8 |
|
|
|
|
|
|
|
6,103 |
|
|
|
|
|
|
|
|
|
|
|
6,103 |
|
Share options exercised |
|
|
14 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Issue of share capital net of transaction costs |
|
|
14 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance as of March 31, 2023 |
|
|
|
|
|
|
767 |
|
|
|
720,280 |
|
|
|
(520,046 |
) |
|
|
(917 |
) |
|
|
200,084 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance as of January 1, 2024 |
|
|
|
|
|
|
847 |
|
|
|
823,166 |
|
|
|
(597,293 |
) |
|
|
(1,636 |
) |
|
|
225,084 |
|
Other comprehensive income |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
336 |
|
|
|
336 |
|
Net loss |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(3,054 |
) |
|
|
|
|
|
|
(3,054 |
) |
Comprehensive loss for the year |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(3,054 |
) |
|
|
336 |
|
|
|
(2,718 |
) |
Equity-settled share-based compensation |
|
|
8 |
|
|
|
|
|
|
|
4,297 |
|
|
|
|
|
|
|
|
|
|
|
4,297 |
|
Share options exercised |
|
|
14 |
|
|
|
1 |
|
|
|
682 |
|
|
|
|
|
|
|
|
|
|
|
683 |
|
Issue of share capital net of transaction costs |
|
|
14 |
|
|
|
183 |
|
|
|
173,257 |
|
|
|
|
|
|
|
|
|
|
|
173,440 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance as of March 31, 2024 |
|
|
|
|
|
|
1,031 |
|
|
|
1,001,402 |
|
|
|
(600,347 |
) |
|
|
(1,300 |
) |
|
|
400,786 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The accompanying notes are an integral part of these unaudited interim condensed consolidated financial
statements.
Notes to the Unaudited Interim Condensed Consolidated Financial Statements of Immatics N.V.
1. Group information
Immatics N.V., together with its
German subsidiary Immatics Biotechnologies GmbH and its U.S. subsidiary, Immatics US Inc., (Immatics or the Group) is a biotechnology group that is primarily engaged in the research and development of T cell redirecting
immunotherapies for the treatment of cancer. Immatics N.V., a Dutch public limited liability company, was converted on July 1, 2020 from Immatics B.V., a Dutch company with limited liability. Immatics Biotechnologies GmbH (Immatics
GmbH) and Immatics US Inc. became wholly-owned subsidiaries of Immatics N.V. as part of the ARYA Merger on July 1, 2020.
Immatics N.V. is
registered with the commercial register at the Netherlands Chamber of Commerce under RSIN 861058926 with a corporate seat in Amsterdam and is located at Paul-Ehrlich Str. 15 in 72076 Tübingen, Germany. Prior to July 1, 2020, Immatics N.V.
was a shell company with no active trade or business or subsidiaries and all relevant assets and liabilities as well as income and expenses were borne by Immatics Biotechnologies GmbH and its U.S. subsidiary Immatics US, Inc. Immatics N.V. is the
ultimate parent company of the Group.
These unaudited interim condensed consolidated financial statements of the Group for the three months ended
March 31, 2024, were authorized for issue by the Audit Committee of Immatics N.V. on May 14, 2024.
2. Significant events and changes in the
current reporting period
The following significant events or transactions occurred during the three months ended March 31, 2024.
On January 22, 2024, the Group closed an offering of 18,313,750 ordinary shares with a public offering price of $11.00 per ordinary share. The Group
received gross proceeds of 185.0 million less transaction costs of 11.5 million, resulting in an increase in share capital of 183 thousand and share premium of 173.3 million.
Macroeconomic environment
Currently, multiple global
uncertainties are existing.
The conflict between Russia and Ukraine and the Palestinian-Israeli conflict have resulted, and may further result, in
significant disruption, instability and volatility in global markets, as well as higher energy and other commodity prices. Since the Company is not currently conducting any business or receiving any material services from vendors located in Russia,
Ukraine or Israel, it does not expect that the ongoing conflicts will have a direct impact on its operations in the near term. However, the Company may be indirectly affected by price increases or certain policy changes, such as new tax legislation,
economic sanctions and comparable measures. While the conflicts are currently not expected to have a direct impact on the Company, this may change in case of further expansion of the scale of the conflicts. In addition, other geopolitical
instabilities might impact the Group in the future.
3. Significant accounting policies
Basis of presentation
The unaudited interim condensed
consolidated financial statements of the Group as of March 31, 2024 and for the three months ended March 31, 2024 and 2023 have been prepared on a going concern basis in accordance with International Accounting Standard 34 (Interim
Financial Reporting), as issued by the International Accounting Standards Board (IASB) and have not been audited or reviewed by a statutory auditor.
In accordance with IAS 34, the unaudited interim condensed consolidated financial statements do not include all the information and disclosures required in
the annual financial statements and should be read in conjunction with the Groups annual financial statements for the year ended December 31, 2023, which have been prepared in accordance with IFRS® Accounting Standards as issued by the International Accounting Standards Board (IASB), taking into account the recommendations of the IFRS Interpretations Committee (IFRIC® Interpretations). In these notes to the unaudited condensed consolidated financial statements, information is provided primarily on the items for which there have been significant changes
compared with the consolidated financial statements of the Group for fiscal year 2023.
The unaudited interim condensed consolidated financial statements
are presented in Euros, which is the functional and reporting currency of the parent, Immatics N.V. Assets and liabilities of foreign operations are translated into Euros at the rate of exchange prevailing at the reporting date. The Unaudited
Interim Condensed Consolidated Statement of Loss is translated at average exchange rates. The currency translation differences are recognized in other comprehensive income.
The accounting policies adopted in the preparation of the unaudited interim condensed consolidated financial
statements are consistent with those followed in the preparation of the Groups annual consolidated financial statements for the year ended December 31, 2023. The new and amended standards and interpretations applicable for the first time
as of January 1, 2024, as disclosed in the notes to the consolidated financial statements for the year ended December 31, 2023, had no impact on the unaudited interim condensed consolidated financial statements of the Group for the three
months ended March 31, 2024.
In April 2024, IFRS 18, Presentation and Disclosure in Financial Statements was issued to achieve
comparability of the financial performance of similar entities. The standard, which replaces IAS 1 Presentation of Financial Statements, impacts the presentation of primary financial statements and notes, including the statement of
earnings where companies will be required to present separate categories of income and expense for operating, investing, and financing activities with prescribed subtotals for each new category. The standard will also require management-defined
performance measures to be explained and included in a separate note within the consolidated financial statements.
The standard is effective for annual
reporting periods beginning on or after January 1, 2027, including interim financial statements, and requires retrospective application. The Company is currently assessing the impact of the new standard.
Estimates and assumptions have to be made in the unaudited interim consolidated financial statements as of March 31, 2024. These have an impact on the
amounts and disclosures of the recognized assets and liabilities, income and expenses, and contingent liabilities. The estimates and judgments are essentially unchanged from the circumstances described in the consolidated financial statements of the
Group for the fiscal year 2023. New developments may result in amounts deviating from the original estimates. These possible developments are outside the sphere of influence of the management.
4. Segment information
The Group manages its operations
as a single segment for the purpose of assessing performance and making operating decisions. The Groups focus is on the research and development of T cell redirecting immunotherapies for the treatment of cancer. The Chief Executive Officer is
the chief operating decision maker who regularly reviews the consolidated operating results and makes decisions about the allocation of the Groups resources.
5. Revenue from collaboration agreements
The Group
currently earns revenue through strategic collaboration agreements with third party pharmaceutical and biotechnology companies. As of March 31, 2024, the Group had four revenue-generating strategic collaboration agreements in place, three with
Bristol-Myers-Squibb (BMS) and the agreement with ModernaTX, Inc. (Moderna), effective in October 2023. Three of the four revenue-generating strategic collaboration agreements are in
pre-clinical stage and the BMS IMA401 collaboration agreement is in clinical stage. The collaboration with Genmab A/S, Copenhagen /Denmark (Genmab) was terminated in March 2024 and the Group
recorded the remaining deferred revenue of 14.9 million from the Genmab collaboration during the three months ended March 31, 2024.
Revenue from collaboration agreements was realized with the following partners:
|
|
|
|
|
|
|
|
|
|
|
Three months ended March 31, |
|
|
|
2024 |
|
|
2023 |
|
|
(Euros in thousands) |
|
Genmab, Denmark |
|
|
14,951 |
|
|
|
(700 |
) |
Moderna, United States |
|
|
9,583 |
|
|
|
|
|
BMS, United States |
|
|
5,735 |
|
|
|
10,496 |
|
|
|
|
|
|
|
|
|
|
Total |
|
|
30,269 |
|
|
|
9,796 |
|
|
|
|
|
|
|
|
|
|
As of March 31, 2024, the Group has not recognized any milestone revenue under the collaboration agreements, due to the
scientific uncertainty of achieving the milestones or the successful commercialization of a product. As of March 31, 2024, Immatics had not received any milestone or royalty payments in connection with the collaboration agreements. The Group
plans to recognize the remaining deferred revenue balance into revenue as it performs the related performance obligations under each contract.
The
revenue for the three months ended March 31, 2023 from the collaboration agreement with Genmab was negative, which was a result of changes to the inputs in the
cost-to-cost model due to an increase in the expected cost of the collaboration, resulting in a reduction in calculated percentage of completion.
Deferred revenue related to the collaboration agreements consists of the following:
|
|
|
|
|
|
|
|
|
|
|
As of |
|
|
|
March 31, 2024 |
|
|
December 31, 2023 |
|
|
|
(Euros in thousands) |
|
Current |
|
|
96,525 |
|
|
|
100,401 |
|
Non-current |
|
|
91,358 |
|
|
|
115,527 |
|
|
|
|
|
|
|
|
|
|
Total |
|
|
187,883 |
|
|
|
215,928 |
|
|
|
|
|
|
|
|
|
|
Deferred revenues are contract liabilities within the scope of IFRS 15.
The Group recognized expenses related to the amortization of capitalized cost of obtaining a contract of 0.3 million and 0.0 million for
the three months ended March 31, 2024 and March 31, 2023.
6. Financial result
Financial income and financial expenses consist of the following:
|
|
|
|
|
|
|
|
|
|
|
Three months ended March 31, |
|
|
|
2024 |
|
|
2023 |
|
|
|
(Euros in thousands) |
|
Change in fair value of liabilities for warrants |
|
|
1,043 |
|
|
|
7,397 |
|
|
|
|
|
|
|
|
|
|
Interest income |
|
|
6,294 |
|
|
|
2,254 |
|
Foreign currency gains |
|
|
5,087 |
|
|
|
541 |
|
|
|
|
|
|
|
|
|
|
Other financial income |
|
|
11,381 |
|
|
|
2,795 |
|
|
|
|
|
|
|
|
|
|
Interest expenses |
|
|
(194 |
) |
|
|
(195 |
) |
Foreign currency losses |
|
|
(17 |
) |
|
|
(3,314 |
) |
Losses on financial instruments |
|
|
(466 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Other financial expenses |
|
|
(677 |
) |
|
|
(3,509 |
) |
Financial result |
|
|
11,747 |
|
|
|
6,683 |
|
|
|
|
|
|
|
|
|
|
The fair value of the warrants decreased from 2.64 ($2.92) per warrant as of December 31, 2023 to 2.50
($2.70) per warrant as of March 31, 2024. The result is a decrease in fair value of liabilities for warrants of 1.0 million and a corresponding expense for the three months ended March 31, 2024.
The fair value of the warrants decreased from 2.35 ($2.51) per warrant as of December 31, 2022 to 1.32 ($1.44) per warrant as of
March 31, 2023. The result is a decrease in fair value of liabilities for warrants of 7.4 million for the three months ended March 31, 2023.
Interest income mainly results from short-term deposits as well as cash balances. Interest expenses mainly result from leases.
Foreign currency gains and losses mainly consist of realized and unrealized gains and losses in connection with our USD holdings of cash and cash equivalents
and short-term deposits in Immatics N.V. and Immatics GmbH.
Losses on financial instruments include expected credit losses on cash and cash equivalents
and Other financial assets for the three months ended March 31, 2024 and 2023.
7. Income Tax
During the three months ended March 31, 2024, Immatics N.V. and Immatics US Inc. generated a net loss within the Group. Immatics GmbH generated a net
income due to the recognition of the remaining upfront payment of 14.9 million within revenue, in connection with the termination of the collaboration with Genmab and correspondingly the Group recognized an income tax expense of
1.3 million and an equivalent current tax liability for the three months ended March 31, 2024.
The income tax expense is calculated based on taxable income of Immatics GmbH for the three months ended
March 31, 2024 and does not take into account any potential income or loss of the following quarter. The Group applied the estimated effective tax rate for the financial year 2024 to the taxable income for the three months ended March 31,
2024. Since no deferred tax assets have been recognized as of December 31, 2023, the Group took into account the tax losses carried forward that can be used to offset the taxable income generated in the three months ended March 31, 2024.
In accordance with §10d para 2 EStG (German income tax code), 70% (corporate tax) / 60% (trade tax) of an income of a given year can be offset with tax losses carried forward. Accordingly, 30% / 40% of the income before tax of Immatics GmbH is
subject to income tax.
As the profit generated by Immatics GmbH during the three months ended March 31, 2024 is considered a one-time profit, no deferred tax assets exceeding the deferred tax liability for temporary differences have been recognized in respect of tax losses carried forward. The current assessment regarding the usability of
deferred tax assets may change, depending on the Groups taxable income in future years, which could result in the recognition of deferred tax assets.
The Group generated losses for all entities within the Group during the three months ended March 31, 2023.
During the three months ended March 31, 2024 and 2023, the Groups German operations were subject to a statutory tax rate of 30.4% and the
Groups U.S. operations were subject to a federal corporate income tax rate of 21%.
Due to changes in ownership in prior periods, there are certain
limitations on tax losses carried forward for net operating losses incurred by Immatics US, Inc., under Section 382 of the U.S. Internal Revenue Code.
8. Share-based payments
Immatics N.V. has two
share-based payment plans. In June 2020, Immatics N.V. established an initial equity incentive plan (2020 Equity Plan). At the Annual General Meeting on June 13, 2022, Immatics shareholders approved the Companys 2022 stock
option and incentive plan (2022 Equity Plan). The 2022 Equity Plan allows the company to grant additional options.
Immatics GmbH previously
issued share-based awards to employees under two different plans. Under the GmbH Stock Appreciation Program 2010 (the 2010 Plan), the Company issued stock appreciation rights (SARs), which the Group accounted for as
cash-settled awards. Under the Immatics GmbH 2016 Equity Incentive Plan (2016 Plan), the Company issued tandem awards, which contained the possibility to function as either a SAR or a stock option. The Group accounted for awards issued
under the 2016 Plan, which were redeemable in either cash or equity shares at the Groups discretion, as equity-settled.
As part of the ARYA Merger,
all outstanding awards under the 2010 Plan and 2016 Plan were replaced by a combination of cash payments and share-based awards under the 2020 Equity Plan in Immatics N.V. Under the 2020 Equity Plan, management and employees have been granted
different types of options, all of which are equity-settled transactions. As part of the replacement, active employees and management members received stock options (Matching Stock Options) to acquire shares in Immatics N.V. The Matching
Stock Options have an exercise price of $10.00 and vested in full on July 31, 2021. The awards have a 10-year contract life.
Share-based Awards
The share-based awards, that were
received by employees as part of the conversion, consisted of Re-investment Shares, Matching Stock Options and Converted Stock Options as described below.
In accordance with the employee re-investment elections, employees received 733,598 shares in Immatics N.V. (Re-investment Shares), which had a fair value of 8.5 million based on the ARYA share price of $15.15, as of the merger on July 1, 2020. The
Re-investment Shares issued represented a modification of awards previously granted under the 2010 Plan and the 2016 Plan. For each ordinary Re-investment Share
received, active employees and management members also received two stock options (Matching Stock Options) to acquire shares in Immatics N.V. The Matching Stock Options have an exercise price of $10.00 and vested in full on July 31,
2021. The award recipient must remain employed by Immatics or one of its affiliates through the vesting date, to receive the option. The awards have a 10-year contract life.
Matching Stock Options outstanding as of March 31, 2024:
|
|
|
|
|
|
|
|
|
|
|
2024 |
|
|
|
Weighted average exercise price in USD |
|
|
Number |
|
Matching Stock Options outstanding on January 1, |
|
|
10.00 |
|
|
|
1,342,648 |
|
Matching Stock Options forfeited |
|
|
|
|
|
|
|
|
Matching Stock Options exercised |
|
|
10.00 |
|
|
|
15,410 |
|
Matching Stock Options expired |
|
|
|
|
|
|
|
|
Matching Stock Options outstanding on March 31, |
|
|
10.00 |
|
|
|
1,327,238 |
|
Matching Stock Options exercisable on March 31, |
|
|
10.00 |
|
|
|
1,327,238 |
|
Weighted average remaining contract life (years) |
|
|
6.25 |
|
|
|
|
|
For any outstanding 2016 Plan and 2010 Plan awards scheduled to vest on or after January 1, 2021, employees received
replacement stock options (Converted Options) to acquire shares in Immatics N.V. The Converted Options have comparable terms as the previous awards, with revised exercise prices reflecting the reorganized capital structure of Immatics.
The options granted under the 2020 Equity Plan that gives employees the right to acquire shares in Immatics N.V. are accounted for as a modification under IFRS 2, with the incremental fair value expensed over the remaining vesting period.
The incremental fair value is the difference between the fair value of the options to purchase ordinary shares under the 2020 Equity Plan to acquire shares in
Immatics N.V. and the fair value of the exchanged unvested SAR (both measured at the date on which the replacement award is issued).
Converted Options
outstanding as of March 31, 2024:
|
|
|
|
|
|
|
|
|
|
|
2024 |
|
|
|
Weighted average exercise price in USD |
|
|
Number |
|
Converted Options outstanding on January 1, |
|
|
2.81 |
|
|
|
503,310 |
|
Converted Options forfeited |
|
|
|
|
|
|
|
|
Converted Options exercised |
|
|
1.46 |
|
|
|
8,615 |
|
Converted Options expired |
|
|
|
|
|
|
|
|
Converted Options outstanding on March 31, |
|
|
2.83 |
|
|
|
494,695 |
|
Converted Options exercisable on March 31, |
|
|
2.83 |
|
|
|
494,695 |
|
Weighted average remaining contract life (years) |
|
|
3.76 |
|
|
|
|
|
Additional grants under the 2020 and 2022 Equity Plan
Service Options
Under the 2020 Equity Plan and the 2022
Equity Plan, Immatics also issues employee stock options with a service requirement (Service Options) to acquire shares of Immatics N.V. The service-based options for employees including management will vest on a four-year time-based
vesting schedule. Under the 2022 Equity Plan, annual service options for members of the Board of Directors will vest entirely after one year. Service Options are granted on a recurring basis. The Company granted Service Options, which were accounted
for using the respective grant date fair value.
Immatics applied a Black-Scholes pricing model to estimate the fair value of the Service Options, with a
weighted average fair value of $9.41 for Service Option granted during the three months ended March 31, 2024 and used the following weighted average assumptions:
|
|
|
|
|
|
|
Three months ended March 31, 2024 |
|
Exercise price in USD |
|
$ |
12.24 |
|
Underlying share price in USD |
|
$ |
12.24 |
|
Volatility |
|
|
90.63 |
% |
Time period (years) |
|
|
6.11 |
|
Risk free rate |
|
|
4.08 |
% |
Dividend yield |
|
|
0.00 |
% |
Service Options outstanding as of March 31, 2024:
|
|
|
|
|
|
|
|
|
|
|
2024 |
|
|
|
Weighted average exercise price in USD |
|
|
Number |
|
Service Options outstanding on January 1, |
|
|
9.87 |
|
|
|
7,757,974 |
|
Service Options granted in 2024 |
|
|
12.24 |
|
|
|
995,900 |
|
Service Options forfeited |
|
|
8.98 |
|
|
|
24,447 |
|
Service Options exercised |
|
|
10.02 |
|
|
|
56,124 |
|
Service Options expired |
|
|
12.30 |
|
|
|
2,806 |
|
Service Options outstanding on March 31, |
|
|
10.15 |
|
|
|
8,670,497 |
|
Service Options exercisable on March 31, |
|
|
10.07 |
|
|
|
3,332,299 |
|
Weighted average remaining contract life (years) |
|
|
8.37 |
|
|
|
|
|
Performance-Based Options (PSUs)
In addition, after the closing of the ARYA Merger, certain executive officers and key personnel of the Group received under the 2020 Equity Plan
performance-based options (PSUs), vesting based on both the achievement of market capitalization milestones and satisfaction of a four-year time-based vesting schedule. The PSUs are split into three equal tranches. The performance
criteria for each of the three respective tranches requires Immatics to achieve a market capitalization of at least $1.5 billion, $2 billion and $3 billion, respectively.
The Company granted PSUs on February 7, 2024, which were accounted for by considering a weighted average fair value of $6.37. A Monte-Carlo simulation
model has been used to measure the fair value at grant date of the PSUs. This model incorporates the impact of the performance criteria regarding market capitalization in the calculation of the awards fair value at grant date. In addition to
the probability of achieving the market capitalization performance criteria, the inputs used in the measurements of the fair value at grant date of the PSUs were as follows:
|
|
|
|
|
|
|
As of February 7, 2024 |
|
Exercise price in USD |
|
$ |
11.15 |
|
Underlying share price in USD |
|
$ |
11.15 |
|
Volatility |
|
|
77.62 |
% |
Time period (years) |
|
|
2.07 |
|
Risk-free rate |
|
|
4.12 |
% |
Dividend yield |
|
|
0.00 |
% |
PSUs outstanding as of March 31, 2024:
|
|
|
|
|
|
|
|
|
|
|
2024 |
|
|
|
Weighted average exercise price in USD |
|
|
Number |
|
PSUs outstanding on January 1, |
|
|
10.08 |
|
|
|
3,642,000 |
|
PSUs granted in 2024 |
|
|
11.15 |
|
|
|
50,000 |
|
PSUs forfeited |
|
|
|
|
|
|
|
|
PSUs outstanding on March 31, |
|
|
10.09 |
|
|
|
3,692,000 |
|
PSUs exercisable on March 31, |
|
|
|
|
|
|
|
|
Weighted average remaining contract life (years) |
|
|
6.35 |
|
|
|
|
|
The Group recognized total employee-related share-based compensation expenses from all plans, during the three months ended
March 31, 2024 and 2023 as set out below:
|
|
|
|
|
|
|
|
|
|
|
Three months ended March 31, |
|
|
|
2024 |
|
|
2023 |
|
|
|
(Euros in thousands) |
|
Research and development expenses |
|
|
(2,268 |
) |
|
|
(3,534 |
) |
General and administrative expenses |
|
|
(2,029 |
) |
|
|
(2,569 |
) |
|
|
|
|
|
|
|
|
|
Total |
|
|
(4,297 |
) |
|
|
(6,103 |
) |
|
|
|
|
|
|
|
|
|
9. Other current and non-current assets
Other current assets consist of the following:
|
|
|
|
|
|
|
|
|
|
|
As of |
|
|
|
March 31, 2024 |
|
|
December 31, 2023 |
|
|
|
(Euros in thousands) |
|
Prepaid expenses |
|
|
10,589 |
|
|
|
10,619 |
|
Value added tax receivables |
|
|
1,641 |
|
|
|
1,644 |
|
Other assets |
|
|
10,436 |
|
|
|
7,119 |
|
|
|
|
|
|
|
|
|
|
Total |
|
|
22,666 |
|
|
|
19,382 |
|
|
|
|
|
|
|
|
|
|
Prepaid expenses include expenses for licenses and software of 6.9 million as of March 31, 2024 and
7.0 million as of December 31, 2023 and prepaid insurance expenses of 0.7 million as of March 31, 2024 and 1.1 million as of December 31, 2023. The Group accrued 0.1 million as of
March 31, 2024 and 0.2 million as of December 31, 2023 of incremental cost for the successful arrangement of the BMS collaboration signed in 2019.
Additionally, prepaid expenses include expenses for maintenance of 1.0 million as of March 31, 2024 and 0.9 million as of
December 31, 2023. The remaining amount is mainly related to prepaid expenses for contract research organizations and travel expenses.
Other assets
include receivables from capital gains tax, prepaid deposit expenses and accrued interest income.
Other
non-current assets consist of the following:
|
|
|
|
|
|
|
|
|
|
|
As of |
|
|
|
March 31, 2024 |
|
|
December 31, 2023 |
|
|
|
(Euros in thousands) |
|
Prepaid expenses |
|
|
765 |
|
|
|
1,414 |
|
Other assets |
|
|
608 |
|
|
|
603 |
|
|
|
|
|
|
|
|
|
|
Total |
|
|
1,373 |
|
|
|
2,017 |
|
|
|
|
|
|
|
|
|
|
Prepaid expenses include the non-current portion of prepayments for licensing
agreements of 0.2 million as of March 31, 2024 and 0.5 million as of December 31, 2023, prepaid maintenance expenses of 0.4 million as of March 31, 2024 and 0.5 million as of
December 31, 2023 and accrued incremental cost of the BMS collaboration agreement of 0.2 million as of March 31, 2024 and 0.4 million as of December 31, 2023. Other assets include the non-current portion for prepaid deposit expenses.
10. Property, plant and equipment, intangible assets and Right-of-use assets
During the three months ended March 31, 2024 and
March 31, 2023, the Group acquired property, plant and equipment and intangible assets in the amount of 7.5 million and 4.1 million, respectively.
The Groups additions include leasehold improvements, lab equipment, office equipment and computer equipment for the research and commercial GMP
manufacturing facility construction in Houston, Texas of 4.9 million for the three months ended March 31, 2024.
During the three months
ended March 31, 2024, there was no material addition in right-of-use assets and corresponding lease liability.
11. Provisions
Provisions consist of the following:
|
|
|
|
|
|
|
|
|
|
|
As of |
|
|
|
March 31, 2024 |
|
|
December 31, 2023 |
|
|
|
(Euros in thousands) |
|
Provision for bonuses |
|
|
1,740 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
|
1,740 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
These amounts include provisions for the Groups annual employee bonuses.
Accounts payables consist of the following:
|
|
|
|
|
|
|
|
|
|
|
As of |
|
|
|
March 31, 2024 |
|
|
December 31, 2023 |
|
|
|
(Euros in thousands) |
|
Accounts payables |
|
|
6,081 |
|
|
|
7,666 |
|
Accrued liabilities |
|
|
14,456 |
|
|
|
17,540 |
|
|
|
|
|
|
|
|
|
|
Total |
|
|
20,537 |
|
|
|
25,206 |
|
|
|
|
|
|
|
|
|
|
13. Other current liabilities
Other current liabilities consist of the following:
|
|
|
|
|
|
|
|
|
|
|
As of |
|
|
|
March 31, 2024 |
|
|
December 31, 2023 |
|
|
|
(Euros in thousands) |
|
Income tax liability |
|
|
5,294 |
|
|
|
4,298 |
|
Payroll tax |
|
|
2,097 |
|
|
|
3,560 |
|
Accrual for vacation and overtime |
|
|
1,504 |
|
|
|
1,277 |
|
Other liabilities |
|
|
695 |
|
|
|
213 |
|
|
|
|
|
|
|
|
|
|
Total |
|
|
9,590 |
|
|
|
9,348 |
|
|
|
|
|
|
|
|
|
|
Other current liabilities are non-interest-bearing and are due within one year. The
carrying amounts of other current liabilities represent fair values due to their short-term nature.
14. Shareholders equity
As of March 31, 2024 and December 31, 2023, the total number of ordinary shares of Immatics N.V. outstanding is 103,053,445 and 84,657,789 with a par
value of 0.01, respectively.
On January 22, 2024, the Group closed an offering of 18,313,750 ordinary shares with a public offering price of
$11.00 per ordinary share. The Group received gross proceeds of 185.0 million less transaction costs of 11.5 million, resulting in an increase in share capital of 183 thousand and share premium of
173.3 million.
Additionally, the number of ordinary shares increased during the three months ended March 31, 2024, due to exercised share
options from the Groups equity incentive plan.
Other reserves are related to accumulated foreign currency translation amounts associated with the
Groups U.S. operations.
15. Related party disclosures
During the three months ended March 31, 2024, the Group did not enter into any new related-party transactions with its key management personnel or with
related entities and did not grant new service options to its Board of Directors.
16. Financial Instruments
Set out below are the carrying amounts and fair values of the Groups financial instruments that are carried in the unaudited interim condensed
consolidated financial statements.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Carrying amount per measurement category |
|
|
|
|
|
|
|
|
|
Financial assets |
|
|
Financial liabilities |
|
|
|
|
|
|
|
(Euros in thousands) |
|
At fair value through profit and loss |
|
|
At amortized cost |
|
|
At fair value through profit and loss |
|
|
At amortized cost |
|
|
IFRS 16 |
|
|
March 31, 2024 |
|
Current/non-current assets |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents |
|
|
|
|
|
|
122,093 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
122,093 |
|
Short-term deposits* |
|
|
|
|
|
|
441,857 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
441,857 |
|
Accounts receivables |
|
|
|
|
|
|
1,781 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,781 |
|
Other current/non-current assets* |
|
|
|
|
|
|
7,650 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
7,650 |
|
Current/non-current
liabilities |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accounts payable |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
20,538 |
|
|
|
|
|
|
|
20,538 |
|
Other current liabilities |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
50 |
|
|
|
|
|
|
|
50 |
|
Liabilities for warrants |
|
|
|
|
|
|
|
|
|
|
17,950 |
|
|
|
|
|
|
|
|
|
|
|
17,950 |
|
Lease liabilities |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
14,639 |
|
|
|
14,639 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
|
|
|
|
|
573,381 |
|
|
|
17,950 |
|
|
|
20,588 |
|
|
|
14,639 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Carrying amount per measurement category |
|
|
|
|
|
|
|
|
|
Financial assets |
|
|
Financial liabilities |
|
|
|
|
|
|
|
(Euros in thousands) |
|
At fair value through profit and loss |
|
|
At amortized cost |
|
|
At fair value through profit and loss |
|
|
At amortized cost |
|
|
IFRS 16 |
|
|
December 31, 2023 |
|
Current/non-current assets |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents |
|
|
|
|
|
|
218,472 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
218,472 |
|
Short-term deposits* |
|
|
|
|
|
|
207,423 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
207,423 |
|
Accounts receivables |
|
|
|
|
|
|
4,093 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
4,093 |
|
Other current/non-current assets* |
|
|
|
|
|
|
4,552 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
4,552 |
|
Current/non-current
liabilities |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accounts payable |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
24,280 |
|
|
|
|
|
|
|
24,280 |
|
Other current liabilities |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
50 |
|
|
|
|
|
|
|
50 |
|
Liabilities for warrants |
|
|
|
|
|
|
|
|
|
|
18,993 |
|
|
|
|
|
|
|
|
|
|
|
18,993 |
|
Lease liabilities |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
15,402 |
|
|
|
15,402 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
|
|
|
|
|
434,540 |
|
|
|
18,993 |
|
|
|
24,330 |
|
|
|
15,402 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
* |
Short-term deposits are classified within the balance sheet item Other financial
assets. Other current/non-current assets comprise mainly of accrued interest and deposits. |
The book value of financial assets and liabilities other than lease liabilities and liabilities for warrants represent a reasonable approximation of the fair
value.
Liabilities for warrants are comprised of the Immatics Warrants issued to investors with a cashless exercise mechanism as a current liability
which the Company accounted for according to provisions of IAS 32. The Company measures the warrants at fair value by using the closing price of warrants at Nasdaq. The warrants are measured in each reporting period. Changes in the fair value are
recognized in the Companys Consolidated Statement of Loss as financial income or expenses, as appropriate. The warrants are classified as Level 1 of the fair value hierarchy. The maturity of the liabilities for warrants is dependent on
the development of the share price as well as the decisions by the Immatics Warrants holders.
17. Earnings and Loss per Share
The Group reported basic and diluted loss per share during the three months ended March 31, 2024 and 2023. Basic and diluted loss per share and basic
earnings per share are calculated by dividing the net profit or loss by the weighted-average number of ordinary shares outstanding for the reporting period. Diluted earnings per share, are calculated by adjusting the weighted-average number of
ordinary shares outstanding for any dilutive effects resulting from equity awards granted to the Board and employees of the Group as well as from publicly traded Immatics Warrants. The Groups equity awards and Immatics Warrants for which the
exercise price is exceeding the Groups weighted average share price, are excluded in the calculation of diluted weighted average number of ordinary shares.
The Group was loss-making during the three months ended March 31, 2024 and during the three months ended March 31, 2023, therefore all instruments
under the 2020 and 2022 Plan are anti-dilutive instruments and are excluded in the calculation of diluted weighted average number of ordinary shares outstanding. The 7,187,500 Immatics Warrants issued in 2020 and outstanding as of March 31,
2024 are dilutive for the three months ended March 31, 2024 as the Groups weighted average share price is exceeding the exercise price and the conversion would have increased the loss per share.
|
|
|
|
|
|
|
|
|
|
|
Three months ended March 31, |
|
|
|
2024 |
|
|
2023 |
|
|
|
(Euros in thousands, except
share and per share data) |
|
Net loss |
|
|
(3,054 |
) |
|
|
(19,747 |
) |
Basic |
|
|
(0.03 |
) |
|
|
(0.26 |
) |
Diluted |
|
|
(0.04 |
) |
|
|
(0.26 |
) |
Weighted average shares outstanding: |
|
|
|
|
|
|
|
|
Basic |
|
|
98,740,222 |
|
|
|
76,671,265 |
|
Diluted |
|
|
105,927,722 |
|
|
|
76,671,265 |
|
18. Commitments and contingencies
The statements regarding contingent liabilities and other financial liabilities described in the consolidated financial statements of the Group for the fiscal
year 2023 are essentially unchanged.
19. Events occurring after the interim reporting period
The Company evaluated further subsequent events for recognition or disclosure through May 14, 2024 and did not identify additional material subsequent
events.
MANAGEMENTS DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
The following discussion and analysis is based on the financial information of Immatics N.V, together with its German subsidiary Immatics Biotechnologies
GmbH and its U.S. subsidiary, Immatics US, Inc. (Immatics, the Company, the Group, we, our). You should read the following discussion and analysis of our financial condition and results of
operations together with our unaudited interim condensed consolidated financial statements for the three month-period ended March 31, 2024 and 2023 included in this interim report. You should also read our operating and financial review and
prospects and our Consolidated Financial Statements for fiscal year 2023, and the notes thereto, in our Annual Report on Form 20-F for the year ended December 31, 2023, filed with the SEC on
March 21, 2024 (the Annual Report). The following discussion is based on the financial information of Immatics prepared in accordance with International Financial Reporting Standards (IFRS), which may differ in material
respects from generally accepted accounting principles in other jurisdictions, including U.S. generally accepted accounting principles.
Overview
We are a clinical-stage biotechnology company dedicated to the development of T cell receptor (TCR)-based immunotherapies
for the treatment of cancer. Our purpose is to deliver a meaningful impact on the lives of cancer patients by developing novel TCR-based immunotherapies that are designed to achieve effect beyond an
incremental clinical benefit. Our focus is the development of product candidates for the treatment of patients with solid tumors, who are inadequately served by existing treatment modalities. We strive to become an industry leading, fully integrated
global biopharmaceutical company engaged in developing, manufacturing and commercializing TCR immunotherapies for the benefit of cancer patients, our employees, our shareholders and our partners.
By utilizing TCR-based therapeutics, we are able to direct T cells to intracellular cancer targets
that are not accessible through classical antibody-based or CAR-T therapies. We believe that by identifying what we call true cancer targets and the right TCRs, we are well positioned to
transform current solid tumor treatment paradigms by delivering cellular and bispecific product candidates that have the potential to substantially improve the lives of cancer patients.
We are developing our targeted immunotherapy product candidates through two distinct treatment modalities:
TCR-engineered autologous (ACTengine) or allogeneic (ACTallo) Adoptive Cell Therapies (ACT) and antibody-like Bispecifics, also called T cell Engaging Receptors
(TCER). Each modality is designed with distinct attributes and mechanisms of action to produce the desired therapeutic effect for multiple cancer patient populations with different unmet medical needs. Our current pipeline comprises
several proprietary TCR-based product candidates in clinical and preclinical development. In addition to our proprietary pipeline, we are collaborating with industry-leading partners, including Bristol Myers
Squibb (BMS), Moderna and Editas Medicine, to develop multiple additional therapeutic programs covering ACT and Bispecifics. In September 2023, we entered into a collaboration with Moderna, which became effective on October 12,
2023. On March 14, 2024, Genmab provided us with a termination notice relating to our collaboration, originally announced in July 2018.
Since our inception, we have focused on developing our technologies and executing our preclinical and clinical research programs with the aim
to deliver the power of T cells to cancer patients. We do not have any products approved for sale. We have funded our operations primarily through equity financing and through payments from our collaboration partners.
We have assembled a team of 524 and 482 FTEs as of March 31, 2024 and December 31, 2023, respectively.
Through March 31, 2024 we have raised 1.32 billion through licensing payments from our collaborators and through private and
public placements of securities. This includes the net proceeds of 173 million received in January 2024 from our public offering. We are holding Cash and cash equivalents and Other financial assets of 564.0 million as of
March 31, 2024. We believe that we have sufficient capital resources to fund our operations through at least the next 12 months.
Since our inception, we have incurred net losses, which have been significant in recent periods. The net profit for the year ended
December 31, 2022 was due to a one-time upfront payment. We expect to continue to incur significant expenses and increasing net losses for the foreseeable future as we continue our research and
development efforts and seek to obtain regulatory approval for and commercialize our product candidates. Our future profitability will be dependent upon the successful development, approval and commercialization of our product candidates and
achieving a level of revenues adequate to support our cost structure. We may never achieve profitability and, unless and until we do, we will continue to need to raise additional capital. Our net losses may fluctuate significantly from period to
period and year to year.
Global Developments
Currently, multiple global uncertainties are existing.
The
conflicts between Russia and Ukraine and the Palestinian-Israeli conflict have resulted, and may further result, in significant disruption, instability and volatility in global markets, as well as higher energy and other commodity prices. Since the
Company is not currently conducting any business or receiving any material services from vendors located in Russia, Ukraine or Israel, it does not expect that the ongoing conflicts will have a direct impact on its operations in the near term.
However, the Company may be indirectly affected by price increases or certain policy changes, such as new tax legislation, economic sanctions and comparable measures. While the conflicts are currently not expected to have a direct impact on our
Company, this may change especially in case of further expansion of the scale of the conflicts. In addition, other geopolitical instabilities might impact the Group in the future.
Our Strategy
Our mission is to
deliver the power of T cells to cancer patients. We seek to execute the following strategy to develop TCR-based immunotherapies for the treatment of cancer, maximizing the value of our technology platforms and
the broad portfolio of product candidates:
|
|
|
Advance IMA203 to FDA approval and commercialization. We plan to commence a registration-enabling
randomized Phase 2/3 trial for ACTengine IMA203 in second-line or later (2L+) melanoma in 2024. For IMA203CD8 (GEN2), in addition to treating melanoma patients, we have also started to expand our clinical footprint outside of melanoma to address a
broader patient population, including those with ovarian and uterine cancer, NSCLC and triple-negative breast cancer while continuing dose escalation with the goal to define the optimal dose for further development. |
|
|
|
Further enhance our cell therapy manufacturing capabilities. Our late-stage clinical cell therapy
development is supported by our manufacturing process, timeline, capabilities and facility. IMA203 and IMA203CD8 (GEN2) cell therapy products are manufactured within 7 days followed by a 7-day QC release
testing at a success rate of >95% to reach the target dose. We have also recently completed construction of a ~100,000 square foot R&D and GMP manufacturing facility with a modular design for efficient and cost-effective scalability to serve
early-stage and registration-enabling clinical trials, as well as potential initial commercial supply. The new site will start GMP manufacturing of cell therapy products in early 2025. Meanwhile, the existing GMP facility, which is run in
collaboration with UT Health, will be remain active until YE 2025 and will also initially serve the Phase 2/3 registrational trial. |
|
|
|
Deliver clinical PoC for our next-generation, half-life extended TCR Bispecifics (TCERs) and further clinical
development. We seek to deliver clinical PoC for our novel TCER platform as fast as possible and plan to provide first clinical data for our two TCER lead candidates (IMA401 targeting MAGEA4/8 and IMA402 targeting PRAME) in 2H 2024. Objectives
are (1) to demonstrate the tolerability of our novel next-generation, half-life extended TCR Bispecifics format, (2) to optimize dosing schedule to a less frequent regimen already during dose escalation based on pharmacokinetic data and
(3) to demonstrate initial clinical anti-tumor activity (i.e. confirmed objective responses according to RECIST 1.1). |
|
|
|
Advance our preclinical pipeline of next-generation, half-life extended TCR Bispecifics. We continue the
development of several innovative preclinical TCER product candidates against so far undisclosed targets for our proprietary and/or partnered pipeline. Our next-generation, half-life extended TCER format used in all our candidates is designed to
safely apply high drug doses for activity in a broad range of tumors, even with low target density, and to achieve a patient-convenient dosing schedule. |
|
|
|
Advance our preclinical pipeline of innovative ACTengine candidates. Our pipeline is strengthened by
innovative cell therapy programs in development, such as ACTengine IMA204, directed against the novel tumor stroma target COL6A3. We believe IMA204 provides a promising and innovative therapeutic opportunity for a broad patient population as a
monotherapy or in combination with TCR-T cells directed against tumor targets. |
|
|
|
Further enhance our cell therapy platform including development of allogeneic
off-the-shelf cell therapies. We continue to actively investigate next-generation enhancement and combination strategies to render ACTengine T cells even more potent
to combat solid tumors, enhance tolerability and further boost the usability of our product candidates. Furthermore, we aim to expedite the supply of cell therapy products to patients and lower costs with our off-the-shelf cell therapy approach, ACTallo. |
|
|
|
Leverage the full potential of strategic collaborations. We have entered strategic collaborations with key
industry partners to maintain our leadership position in the TCR therapeutics field and are also actively seeking to enter further strategic collaborations with industry leading partners to strengthen our proprietary pipeline. We intend to generate
value from these strategic collaborations by developing transformative, cutting-edge therapeutics through the combination of synergistic capabilities and technologies, and we benefit from upfront payments, potential milestone payments and royalties
for product candidates that our partners successfully advance into and through clinical development and towards commercial launch. |
|
|
|
Enhance the competitive edge of our technology platforms. Our target and TCR discovery platforms,
XPRESIDENT, XCEPTOR and XCUBE are the foundation for the further strengthening of our product pipeline and our position in the field of TCR-based therapies. Our goal is to maintain and expand our competitive
edge with these proprietary and differentiated platform technologies. |
|
|
|
Strengthen our intellectual property portfolio. We intend to continuously build and maintain our
intellectual property portfolio to successfully defend and strengthen our position in the field of TCR therapies. |
Portfolio Update
On May 14, 2024, Immatics N.V. (the Company or Immatics) provided a data update from its ongoing Phase 1 trial with ACTengine® IMA203 for its melanoma patients at the defined recommended Phase 2 dose (RP2D). The data cut-off was April 25, 2024.
Safety Data:
|
|
|
65 patients were evaluable for safety analysis across all dose levels and all tumor types |
|
|
|
Favorable safety profile at doses as high as ~10x109 TCR-T cells |
|
|
|
Mostly mild to moderate CRS |
|
|
|
Infrequent ICANS (6.2% Gr1, 4.6% Gr2, 4.6% Gr3) |
|
|
|
No IMA203-related Grade 5 Adverse Events |
|
|
|
Full IMA203 monotherapy safety profile is generally consistent with safety in melanoma subset
|
All treatment-emergent adverse events (TEAEs) with ≥ Grade 3 regardless of relatedness to study treatment. 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 Cytokine release syndrome 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 (25-Apr-2024); 1 One additional patient who received IMA203 TCR-T cells shortly
before data cut-off is not included; no grade ≥3 serious adverse events were reported for this patient in the safety database at data cut-off; 2 Two patients with disease progression after first IMA203 infusion received exploratory second IMA203 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; 3
ICANS: Immune effector cell-associated neurotoxicity syndrome; 4 Fatal Adverse events were not considered related to any study drug; 5
Patient died from sepsis of unknown origin and did not receive IMA203 TCR-T cells; 6 One additional case of acute kidney injury without severity grading
entered in eCRF at data cut-off; 7 DLT: Dose limiting toxicity in phase 1a at DL2 reported on March 17, 2021.
Clinical ActivityAs of the data cut-off on April 25, 2024, 30 PRAME-positive and HLA-A*02:01-positive patients with cutaneous, uveal, mucosal, or melanoma of unknown primary infused with IMA203 at the RP2D (1-10x109 total TCR-T cells) across Phase 1a or Phase 1b were evaluable for efficacy analysis
|
|
|
Confirmed objective response rate (cORR) of 55% (16/29) |
|
|
|
Disease control rate of 90% (27/30) |
|
|
|
Tumor shrinkage in 87% (26/30) of patients |
|
|
|
Median duration of response (mDOR) was 13.5 months (min 1.2+, max 21.5+ months) including 11 of 16 confirmed
objective responses ongoing at data cut-off and longest duration of response ongoing at >21 months after infusion |
|
|
|
Confirmed response rates are similar across all melanoma subtypes: (56% (9/16) in cutaneous melanoma; 54% (7/13)
in other melanoma subtypes) |
cPR: Confirmed Partial Response; PR: Partial Response; SD: Stable Disease; PD: Progressive Disease; BL: Baseline
Components of Operating Results
Revenue from Collaboration Agreements
To date, we have not generated any revenue from the sale of pharmaceutical products. Our revenue has been solely derived from our collaboration
agreements, such as with BMS, Genmab and Moderna. Our revenue from collaboration agreements consists of upfront payments as well as reimbursement of research and development expenses.
Upfront payments allocated to the obligation to perform research and development services are initially recorded on our statement of financial
position as deferred revenue and are subsequently recognized as revenue on a cost-to-cost measurement basis, in accordance with our accounting policy as described
further under Critical Accounting Estimates.
As part of the collaboration arrangements, we grant exclusive licensing rights
for the development and commercialization of future product candidates, developed for specified targets defined in the respective collaboration agreement. We carry out our research activities using our proprietary technology and know-how, participate in joint steering committees, and prepare data packages. In two of our four current revenue generating collaboration agreements, these commitments represent one combined performance obligation,
because the research activities are mutually dependent and the collaborator is unable to derive significant benefit from our access to these targets without our research activities, which are highly specialized and cannot be performed by other
organizations. For the collaboration signed with BMS in December 2021, we identified two separate performance obligations, because the license is a distinct obligation and the clinical trial services will not result in a modification of the license.
For the collaboration signed with Moderna in September 2023, the Group identified the following distinct performance obligations: initial early pre-clinical targets from the TCER part (Early TCER
Activities), one initial advanced pre-clinical target from the TCER part (Advanced TCER Activities) and four distinct performance obligations which, due to their identical accounting
treatment as license accesses, are jointly accounted for as one performance obligation (Database Activities).
All
collaboration agreements resulted in a total of 525.7 million of payments through March 31, 2024. We received 113.0 million ($120.0 million) in connection with the strategic collaboration agreement with Moderna and a
13.7 million ($15.0 million) Opt-in payment from our collaboration partner BMS in 2023. As part of the agreements, we contribute insights from XPRESIDENT and other technologies, as well as commit to
participating in joint research activities. In addition, we agree to license certain target rights and the potential product candidates developed under the collaboration.
Under each of our revenue generating collaboration agreements, we are entitled to receive payments for certain development and commercial
milestone events, in addition to royalty payments upon successful commercialization of a product. The uncertainty of achieving these milestones significantly impacts our ability to generate revenue.
Our ability to generate revenue from sales of pharmaceutical products and to become profitable depends on the successful commercialization of
product candidates by us and/or by our collaboration partners. In the foreseeable future, we do not expect revenue from product sales. To the extent that existing or potential future collaborations generate revenue, our revenue may vary due to many
uncertainties in the development of our product candidates and other factors.
Research and Development Expenses
Research and development expenses consist primarily of personnel-related costs (including share-based compensation) for the various research
and development departments, intellectual property (IP) expenses, facility-related costs and amortization as well as direct expenses for clinical and preclinical programs.
Our core business is focused on the following initiatives with the goal of providing novel TCR-based
immunotherapies to cancer patients:
|
|
|
Advance IMA203 to FDA approval and commercialization; |
|
|
|
Further enhance our cell therapy manufacturing capabilities; |
|
|
|
Deliver clinical PoC for our next-generation, half-life extended TCR Bispecifics (TCERs) and further clinical
development; |
|
|
|
Advance our preclinical pipeline of next-generation, half-life extended TCR Bispecifics; |
|
|
|
Advance our preclinical pipeline of innovative ACTengine candidates; |
|
|
|
Further enhance our cell therapy platform including development of allogeneic off-the-shelf cell therapies; |
|
|
|
Leverage the full potential of strategic collaborations; |
|
|
|
Enhance the competitive edge of our technology platforms; and |
|
|
|
Strengthen our intellectual property portfolio. |
Research expenses are defined as costs incurred for current or planned investigations undertaken with the prospect of gaining new scientific
or technical knowledge and understanding. All research and development costs are expensed as incurred due to scientific uncertainty.
We
expect our research and development expenses to increase substantially in the future as we advance existing and future proprietary product candidates into and through clinical studies and pursue regulatory approval. The process of conducting the
necessary clinical studies to obtain regulatory approval is costly and time-consuming. We expect to increase our headcount to support our continued research activities and to advance the development of our product candidates. Clinical studies
generally become larger and more costly to conduct as they advance into later stages and, in the future, we will be required to make estimates for expense accruals related to clinical study expenses. At this time, we cannot reasonably estimate or
know the nature, timing and estimated costs of the efforts that will be necessary to complete the development of any product candidates that we develop from our programs. Our research and development programs are at an early stage. We must
demonstrate our products safety and efficacy through extensive clinical testing. We may experience numerous unforeseen events during, or as a result of, the testing process that could delay or prevent commercialization of our products,
including but not limited to the following:
|
|
|
after reviewing trial results, we or our collaborators may abandon projects previously believed to be promising;
|
|
|
|
we, our collaborators, or regulators may suspend or terminate clinical trials if the participating subjects or
patients are being exposed to unacceptable health risks; |
|
|
|
our potential products may not achieve the desired effects or may include undesirable side effects or other
characteristics that preclude regulatory approval or limit their commercial use if approved; |
|
|
|
contract manufacturing may not meet the necessary standards for the production of the product candidates or may
not be able to supply the product candidates in a sufficient quantity; |
|
|
|
regulatory authorities may find that our clinical trial design or conduct does not meet the applicable approval
requirements; and |
|
|
|
safety and efficacy results in various human clinical trials reported in scientific and medical literature may
not be indicative of results we obtain in our clinical trials. |
Clinical testing is very expensive, can take many years,
and the outcome is uncertain. It could take several years before we learn the results from any clinical trial using ACT or TCR Bispecifics. The data collected from our clinical trials may not be sufficient to support approval by the FDA, the EMA or
comparable regulatory authorities of our ACT or TCR Bispecific product candidates for the treatment of solid tumors. The clinical trials for our products under development may not be completed on schedule and the FDA, EMA or regulatory authorities
in other countries may not ultimately approve any of our product candidates for commercial sale. If we fail to adequately demonstrate the safety and effectiveness of any product candidate under development, we may not receive regulatory approval for
those product candidates, which would prevent us from generating revenues or achieving profitability.
General and Administrative
Expenses
General and administrative expenses consist primarily of personnel-related costs (including share-based compensation) for
finance, legal, human resources, business development and other administrative and operational functions, professional fees, accounting and legal services, information technology and facility-related costs. These costs relate to the operation of the
business, unrelated to the research and development function or any individual program.
Due to our planned increase in research and
development activities as explained above, we also expect that our general and administrative expenses might increase. We might incur increased accounting, audit, legal, regulatory, compliance, director and officer insurance costs. Additionally, if
and when a regulatory approval of a product candidate appears likely, we anticipate an increase in payroll and expenses as a result of our preparation for commercial operations.
Financial Result
Financial result consists of income and expenses from changes in fair value of warrant liability as well as both other financial income and
other financial expenses. Our warrants are classified as liabilities for warrants. The change in fair value of liabilities for warrants consists of the change in fair value of these warrants. Other financial income results primarily from interest
income and foreign exchange gains. Other financial expenses consist of interest expenses related to lease liabilities, foreign exchange losses and expected credit losses.
Results of Operations
Comparison of the Three Months Ended March 31, 2024 and March 31, 2023
The following table summarizes our consolidated statements of operations for each period presented:
|
|
|
|
|
|
|
|
|
|
|
Three months ended March 31, |
|
|
|
2024 |
|
|
2023 |
|
|
|
(Euros in thousands, except
per share data) |
|
Revenue from collaboration agreements |
|
|
30,269 |
|
|
|
9,796 |
|
Research and development expenses |
|
|
(32,108 |
) |
|
|
(27,581 |
) |
General and administrative expenses |
|
|
(11,642 |
) |
|
|
(9,586 |
) |
Other income |
|
|
12 |
|
|
|
941 |
|
|
|
|
|
|
|
|
|
|
Operating result |
|
|
(13,469 |
) |
|
|
(26,430 |
) |
Change in fair value of liabilities for warrants |
|
|
1,043 |
|
|
|
7,397 |
|
Other financial income |
|
|
11,381 |
|
|
|
2,795 |
|
Other financial expenses |
|
|
(677 |
) |
|
|
(3,509 |
) |
|
|
|
|
|
|
|
|
|
Financial result |
|
|
11,747 |
|
|
|
6,683 |
|
|
|
|
|
|
|
|
|
|
Loss before taxes |
|
|
(1,722 |
) |
|
|
(19,747 |
) |
Taxes on income |
|
|
(1,332 |
) |
|
|
|
|
Net loss |
|
|
(3,054 |
) |
|
|
(19,747 |
) |
|
|
|
|
|
|
|
|
|
Net loss per share: |
|
|
|
|
|
|
|
|
Basic |
|
|
(0.03 |
) |
|
|
(0.26 |
) |
Diluted |
|
|
(0.04 |
) |
|
|
(0.26 |
) |
Revenue from Collaboration Agreements
The following table summarizes our collaboration revenue for the periods indicated:
|
|
|
|
|
|
|
|
|
|
|
Three months ended March 31, |
|
|
|
2024 |
|
|
2023 |
|
|
(Euros in thousands) |
|
Genmab, Denmark |
|
|
14,951 |
|
|
|
(700 |
) |
Moderna, United States |
|
|
9,583 |
|
|
|
|
|
BMS, United States |
|
|
5,735 |
|
|
|
10,496 |
|
|
|
|
|
|
|
|
|
|
Total |
|
|
30,269 |
|
|
|
9,796 |
|
|
|
|
|
|
|
|
|
|
Our revenue from collaboration agreements increased from 9.8 million for the three months ended
March 31, 2023 to 30.3 million for the three months ended March 31, 2024. The increase in revenue of 20.5 million is mainly due to the recognition of the remaining deferred revenue for the collaboration with Genmab,
which was terminated in March 2024. In addition, the new collaboration with Moderna, which we entered into in October 2023, resulted in revenue of 5.7 million for the three months ended March 31, 2024.
The revenue for the three months ended March 31, 2023 from the collaboration agreement with Genmab is negative, which was a result of
changes to the inputs in the cost-to-cost model resulting from an increase in the expected cost of the collaboration resulting in a reduction in calculated percentage of
completion.
We did not achieve any milestones or receive any royalty payments in connection with our collaboration agreements during the
presented periods.
Research and Development Expenses
The following table summarizes our research and development expenses for the periods indicated:
|
|
|
|
|
|
|
|
|
|
|
Three months ended March 31, |
|
|
|
2024 |
|
|
2023 |
|
|
|
(Euros in thousands) |
|
Direct external research and development expenses by program: |
|
|
|
|
|
|
|
|
ACT Programs |
|
|
(4,758 |
) |
|
|
(3,599 |
) |
TCR Bispecifics Programs |
|
|
(1,857 |
) |
|
|
(2,316 |
) |
Other programs |
|
|
(1,965 |
) |
|
|
(1,591 |
) |
|
|
|
|
|
|
|
|
|
Sub-total direct external expenses |
|
|
(8,580 |
) |
|
|
(7,506 |
) |
|
|
|
|
|
|
|
|
|
Indirect research and development expenses: |
|
|
|
|
|
|
|
|
Personnel related (excluding share-based compensation) |
|
|
(13,399 |
) |
|
|
(9,909 |
) |
Share-based compensation expenses |
|
|
(2,268 |
) |
|
|
(3,534 |
) |
IP expenses |
|
|
(1,804 |
) |
|
|
(2,350 |
) |
Facility and depreciation |
|
|
(2,528 |
) |
|
|
(1,776 |
) |
Other indirect expenses |
|
|
(3,529 |
) |
|
|
(2,506 |
) |
|
|
|
|
|
|
|
|
|
Sub-total indirect expenses |
|
|
(23,528 |
) |
|
|
(20,075 |
) |
|
|
|
|
|
|
|
|
|
Total |
|
|
(32,108 |
) |
|
|
(27,581 |
) |
|
|
|
|
|
|
|
|
|
Direct external research and development expenses for our ACT programs increased from 3.6 million
for the three months ended March 31, 2023 to 4.8 million for the three months ended March 31, 2024. This increase mainly resulted from increased activities in our clinical trials. Direct external research and development
expenses for our TCR Bispecifics programs decreased from 2.3 million for the three months ended March 31, 2023 to 1.9 million for the three months ended March 31, 2024. This decrease mainly resulted from less
activities in our preclinical studies for IMA402, which was transitioned into clinical development during the year ended December 31, 2023.
Direct external research and development expenses for our other programs such as technology platforms and collaboration agreements increased
from 1.6 million for the three months ended March 31, 2023 to 2.0 million for the three months ended March 31, 2024. This increase mainly resulted from higher activities for IMA401, which is being developed in a
collaboration with BMS, as well as from increased activities from the Moderna collaboration.
We do not allocate indirect research and
development expenses by program, as our research and development personnel work across programs. Our intellectual property expenses are incurred for the protection of cancer antigen targets, T cell receptors, antibodies, bispecific molecules, and
antigen discovery platforms which are beneficial to the whole research and development group rather than for specific programs. Our programs use common research and development facilities and laboratory equipment, and we also incur other costs such
as general laboratory material or maintenance expenses that are incurred for commonly used activities within the whole research and development group.
Personnel-related expenses increased from 9.9 million for the three months ended March 31, 2023 to 13.4 million for
the three months ended March 31, 2024. This increase resulted from our headcount growth due to our increased research and development activities including clinical trials. Share-based compensation expenses decreased from 3.5 million
for the three months ended March 31, 2023 to 2.3 million for the three months ended March 31, 2024. Shared-based compensation expenses decrease over time mainly due to the fact that certain awards granted as part of the ARYA
Merger have fully vested. IP expenses decreased from 2.4 million for the three months ended March 31, 2023 to 1.8 million for the three months ended March 31, 2024. Facility and depreciation expenses increased from
1.8 million for the three months ended March 31, 2023 to 2.5 million for the three months ended March 31, 2024. This increase resulted from the acquisition of laboratory equipment and leasehold improvements. Other
indirect expenses increased from 2.5 million for the three months ended March 31, 2023 to 3.5 million for the three months ended March 31, 2024. This increase resulted from our expanded research and development
activities.
General and Administrative Expenses
The following table summarizes our general and administrative expenses for the periods indicated:
|
|
|
|
|
|
|
|
|
|
|
Three months ended March 31, |
|
|
|
2024 |
|
|
2023 |
|
|
|
(Euros in thousands) |
|
Share-based compensation expenses |
|
|
(2,029 |
) |
|
|
(2,569 |
) |
Personnel related (excluding share-based compensation) |
|
|
(3,794 |
) |
|
|
(3,550 |
) |
Professional and consulting fees |
|
|
(2,078 |
) |
|
|
(960 |
) |
Other external general and administrative expenses |
|
|
(3,741 |
) |
|
|
(2,507 |
) |
|
|
|
|
|
|
|
|
|
Total |
|
|
(11,642 |
) |
|
|
(9,586 |
) |
General and administrative expenses increased from 9.6 million for the three months ended
March 31, 2023 to 11.6 million for the three months ended March 31, 2024.
Share-based compensation expenses
decreased from 2.6 million for the three months ended March 31, 2023 to 2.0 million for the three months ended March 31, 2024. Shared-based compensation expenses decrease over time mainly due to the fact that certain
awards granted as part of the ARYA Merger have fully vested.
Personnel related general and administrative expenses, excluding share-based
compensation, increased from 3.6 million for the three months ended March 31, 2023 to 3.8 million for the three months ended March 31, 2024. The increase mainly resulted from an increased headcount in our finance, IT,
human resources and communications functions.
Professional and consulting fees increased from 1.0 million for the three months
ended March 31, 2023 to 2.1 million for the three months ended March 31, 2024. The increase in professional and consulting fees resulted mainly from higher audit, legal and consulting expenses.
Other external expenses increased from 2.5 million for the three months ended March 31, 2023 to 3.7 million for the
three months ended March 31, 2024. The increase in other expenses mainly resulted from increased insurance payments, depreciation and facility expenses.
Change in fair value of warrant liabilities
Subsequent to the Business Combination, there were 7,187,500 warrants outstanding, which were classified as financial liabilities through
profit and loss. The warrants entitle the holder to purchase one ordinary share at an exercise price of $11.50 per share. The warrants will expire five years after the completion of the Business Combination or earlier upon redemption or liquidation
in accordance with their terms.
The fair value of the warrants decreased from 2.64 ($2.92) per warrant as of December 31, 2023
to 2.50 ($2.70) per warrant as of March 31, 2024. The result is a decrease in fair value of liabilities for warrants of 1.0 million and a corresponding income for the three months ended March 31, 2024.
Other Financial Income and Other Financial Expenses
Other financial income increased from 2.8 million for the three months ended March 31, 2023 to 11.4 million for the
three months ended March 31, 2024. The increase mainly resulted from interest income and unrealized foreign exchange gains.
Other
financial expenses decreased from 3.5 million for the three months ended March 31, 2023 to 0.7 million for the three months ended March 31, 2024. The decrease mainly resulted from lower foreign exchange losses.
Taxes on income
Taxes on
income increased from 0.0 million for the three months ended March 31, 2023 to 1.3 million for the three months ended March 31, 2024. The increase mainly resulted from a taxable profit of Immatics GmbH due to revenue
recognized in conjunction with the termination of the Genmab collaboration.
Liquidity and Capital Resources
Cash and cash equivalents decreased from 218.5 million as of December 31, 2023 to 122.1 million as of March 31,
2024.
We believe our existing Cash, cash equivalents and Other financial assets will be sufficient to fund our operating expenses and
capital expenditure requirements through at least the next 12 months. We may consider raising additional capital to pursue strategic investments, to take advantage of financing opportunities or for other reasons.
Sources and Uses of Liquidity
We have
incurred losses since inception, with the exception of the year ended December 31, 2022. As of March 31, 2024, we had an accumulated deficit of 600.3 million.
We have funded our operations primarily from public offerings and private placements of our equity securities as well as upfront and other
payments from collaboration agreements.
In January 2024, we received 173.4 million net proceeds (after deducting the
underwriting discount, fees and offering expenses payable by the company), from an offering of 18,313,750 ordinary shares.
In the year
ended December 31, 2023, we received (i) 113.0 million ($120.0 million) in connection with the strategic collaboration agreement with Moderna; (ii) a 13.7 million ($15.0 million)
Opt-in payment from our collaboration partner BMS; and (iii) 31.5 million from a private placement of equity securities. Additionally, we have established an at-the-market (ATM) offering program pursuant to which we may, from time to time, issue and sell shares that have an aggregate offering price of $100 million. For the year ended
December 31, 2023, 5.5 million shares were sold under the ATM agreement with Leerink Partners LLC and we collected a gross amount of 58.8 million. There were no shares sold under the ATM agreement during the three months ended
March 31, 2024.
We plan to utilize the existing Cash, cash equivalents and Other financial assets on hand primarily to fund our
operating activities associated with our research and development initiatives to continue or commence clinical trials and seek regulatory approval for our product candidates. We also expect to continue investing in laboratory and manufacturing
equipment and operations to support our anticipated growth. Cash in excess of immediate requirements is invested in accordance with our investment policy with an emphasis on liquidity and capital preservation and consist primarily of cash in banks
and short-term deposits.
Cash Flows
The following table summarizes our cash flows for each period presented:
|
|
|
|
|
|
|
|
|
|
|
Three months ended March 31, |
|
|
|
2024 |
|
|
2023 |
|
|
|
(Euros in thousands) |
|
Net cash provided by / (used in): |
|
|
|
|
|
|
|
|
Operating activities |
|
|
(32,605 |
) |
|
|
(23,715 |
) |
Investing activities |
|
|
(241,818 |
) |
|
|
(3,719 |
) |
Financing activities |
|
|
174,645 |
|
|
|
(866 |
) |
|
|
|
|
|
|
|
|
|
Total |
|
|
(99,778 |
) |
|
|
(28,300 |
) |
|
|
|
|
|
|
|
|
|
Operating Activities
We primarily derive cash from our collaboration agreements. Our cash used in operating activities is significantly influenced by our use of
cash for operating expenses and working capital to support the business. Historically we experienced negative cash flows from operating activities as we have invested in the development of our technologies in our clinical and preclinical development
of our product candidates.
Our net cash outflow from operating activities for the three months ended March 31, 2024 was
32.6 million. This was comprised by a loss of 3.1 million, an increase in working capital of 27.5 million, net foreign exchange differences and expected credit losses of 4.5 million, other effects of
3.8 million, and a non-cash income of 1.0 million related to the change in fair value of the warrants, partly offset by depreciation and amortization charge of 3.0 million and non-cash charges from equity-settled share-based compensation expenses for employees of 4.3 million.
Our net cash outflow from operating activities for the three months ended March 31,
2023 was 23.7 million. This was comprised by a loss of 19.7 million, an increase in working capital of 6.7 million, other effects of 0.9 million, and a non-cash
income of 7.4 million related to the change in fair value of the warrants, partly offset by depreciation and amortization charge of 1.8 million, net foreign exchange differences and expected credit losses of
3.1 million and non-cash charges from equity-settled share-based compensation expenses for employees of 6.1 million.
Investing Activities
Our
net outflow of cash from investing activities for the three months ended March 31, 2024 was 241.8 million. This consisted primarily of cash paid in the amount of 290.6 million for short-term deposit investments that are
classified as Other financial assets and held with financial institutions to finance the company, 9.2 million as payment for new equipment and intangible assets, partially offset by cash received from maturity of bonds and short-term
deposits of 58.0 million.
Our net outflow of cash from investing activities for the three months ended March 31, 2023 was
3.7 million. This consisted primarily of cash paid in the amount of 67.7 million for bond and short-term deposit investments that are classified as Other financial assets and held with financial institutions to finance the
company, 4.3 million as payment for new equipment and intangible assets, partially offset by cash received from maturity of bonds of 68.3 million.
Financing Activities
For
the three months ended March 31, 2024, net cash provided from financing activities amounted to 174.6 million. On January 22, 2024, the Company closed an offering of 18,313,750 ordinary shares with a public offering price of
$11.00 per ordinary share. The Company received net proceeds of 173.4 million after deducting the underwriting discount and fees and offering expenses and intends to use the net proceeds from this offering to fund the continued research
and development of the Groups pipeline, the manufacturing and production of product candidates and for working capital. In addition, the Group received 0.7 million from option exercises under the Equity Plans and
0.5 million from lease agreements..
For the three months ended March 31, 2023, net cash used from financing activities
amounted to 0.9 million. This was mainly driven by the principal portion of payments in connection with lease contracts.
Operation and
Funding Requirements
Historically, we have incurred significant losses due to our substantial research and development expenses. We
have an accumulated deficit of 600.3 million as of March 31, 2024. We expect our expenses to increase in connection with our ongoing activities, particularly as we continue the research and development of, continue or commence
clinical trials including GMP manufacturing of, and seek regulatory approval for, our product candidates. We believe that we have sufficient financial resources available to fund our projected operating requirements for at least the next twelve
months. Because the outcome of our current and planned clinical trials is highly uncertain, we cannot reasonably estimate the actual amounts necessary to successfully complete the development and commercialization of our product candidates. For
example, our costs will increase if we experience any delays in our current and planned clinical trials. Our future funding requirements will depend on many factors, including, but not limited to:
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1. |
progress, timing, scope and costs of our clinical trials, including the ability to timely initiate clinical
sites, enroll patients and manufacture ACT and TCR Bispecific product candidates for our ongoing, planned and potential future clinical trials; |
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time and cost to conduct IND- or
CTA-enabling studies for our preclinical programs; |
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3. |
time and costs required to perform research and development to identify and characterize new product candidates
from our research programs; |
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time and cost necessary to obtain regulatory authorizations and approvals that may be required by regulatory
authorities to execute clinical trials or commercialize our products; |
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our ability to successfully commercialize our product candidates, if approved; |
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6. |
our ability to have clinical and commercial products successfully manufactured consistent with FDA, the EMA and
comparable regulatory authorities regulations; |
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7. |
amount of sales and other revenues from product candidates that we may commercialize, if any, including the
selling prices for such potential products and the availability of adequate third-party coverage and reimbursement for patients; |
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8. |
sales and marketing costs associated with commercializing our products, if approved, including the cost and
timing of building our marketing and sales capabilities; |
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9. |
cost of building, staffing and validating our manufacturing processes, which may include capital expenditure;
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10. |
terms and timing of our current and any potential future collaborations, licensing or other arrangements that
we have established or may establish; |
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11. |
cash requirements of any future acquisitions or the development of other product candidates;
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12. |
costs of operating as a public company; |
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13. |
time and cost necessary to respond to technological, regulatory, political and market developments;
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14. |
costs of filing, prosecuting, defending and enforcing any patent claims and other IP rights; and
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15. |
costs associated with any potential business or product acquisitions, strategic collaborations, licensing
agreements or other arrangements that we may establish. |
Identifying potential product candidates and conducting
preclinical studies and clinical trials is a time-consuming, expensive and uncertain process that takes many years to complete, and we may never generate the necessary data or results required to obtain regulatory approval and commercialize our
product candidates. In addition, our product candidates, if approved, may not achieve commercial success. Our commercial revenues, if any, will be derived from sales of products that we do not expect to be commercially available for many years, if
at all. Accordingly, we will need to continue to rely on additional financing to achieve our business objectives. Adequate additional financing may not be available to us on acceptable terms, or at all.
Unless and until we can generate sufficient revenue to finance our cash requirements, which may never happen, we may seek additional capital
through a variety of means, including through public and private equity offerings and debt financings, credit and loan facilities and additional collaborations. If we raise additional capital through the sale of equity or convertible debt
securities, our existing shareholders ownership interest will be diluted, and the terms of such equity or convertible debt securities may include liquidation or other preferences that are senior to or otherwise adversely affect the rights of
our existing shareholders. If we raise additional capital through the sale of debt securities or through entering into credit or loan facilities, we may be restricted in our ability to take certain actions, such as incurring additional debt, making
capital expenditures, acquiring or licensing IP rights, declaring dividends or encumbering our assets to secure future indebtedness. Such restrictions could adversely impact our ability to conduct our operations and execute our business plan. If we
raise additional capital through collaborations with third parties, we may be required to relinquish valuable rights to our IP or product candidates or we may be required to grant licenses for our IP or product candidates on unfavorable terms. If we
are unable to raise additional capital when needed, we may be required to delay, limit, reduce or terminate our product development efforts or we may be required to grant rights to third parties to develop and market our product candidates that we
would otherwise prefer to develop and market ourselves. For more information as to the risks associated with our future funding needs, see Risk FactorsRisks Related to Our Financial Position in our Annual Report.
Critical Accounting Estimates
Our
unaudited interim condensed consolidated financial statements for the three month-period ended March 31, 2024 and 2023, respectively, have been prepared in accordance with International Accounting Standard 34 (Interim Financial Reporting), as
issued by the International Accounting Standards Board.
The preparation of the consolidated financial statements for the fiscal year
ended December 31, 2023 and the three months ended March 31, 2024 in accordance with IFRS required the use of estimates and assumptions by the management that affect the value of assets and liabilities as well as contingent assets
and liabilities as reported on the balance sheet date, and revenues and expenses arising during the year. The main areas in which assumptions, estimates and the exercising of a degree of discretion are appropriate relate to the determination
of revenue recognition, research and development expenses, and share-based compensations as well as income taxes.
Our estimates are based
on historical experience and other assumptions that are considered appropriate in the circumstances, and parameters available when the consolidated financial statements were prepared. Existing circumstances and assumptions about future developments,
however, may change due to market changes or circumstances arising that are beyond our control. Hence, our estimates may vary from the actual values.
While our material accounting policies are more fully discussed in our consolidated financial statements included in our Annual Report, we
believe that the following accounting policies are critical to the process of making significant judgments and estimates in the preparation of our unaudited interim condensed consolidated financial statements.
Revenue Recognition for Collaboration Agreements
We recognize revenue through collaboration and license agreements and reimbursement for research and development costs.
Under our collaboration and license agreements, we may receive upfront licensing payments, milestone payments and reimbursement of research
and development expenses. Such collaboration agreements also include licenses of certain of our IP to the respective collaborators. As these agreements are comprised of several commitments, it must be assessed whether these commitments are capable
of being distinct within the context of the contract. For two of our four revenue generating collaboration agreements, we determined that the commitments included in each agreement represented single combined performance obligations, with a single
measure of progress. The performance obligation is accounted for as a performance obligation satisfied over time on a cost-to-cost basis, as our collaboration partner
simultaneously receives and consumes the benefit from our performance. Upfront licensing payments and reimbursement for development expenses are initially deferred on our statement of financial position and subsequently recognized as revenue over
time as costs are incurred.
For our collaboration with BMS regarding IMA401 that was signed in December 2021, we concluded that the
commitments from the collaboration agreement represented two distinct performance obligations. The granted license is transferred at a point in time at the effective date of the agreement and we recognized the revenue allocated to the license at the
effective date. The performance obligation related to promised clinical trial services is satisfied over time. We transfer control of these agreed services over time and therefore recognize revenue over time on a cost-to-cost basis. The transaction price allocated to the commitment for clinical trial services is initially deferred on our statement of financial position and subsequently recognized as revenue as costs
are incurred.
For our collaboration with Moderna that was signed in September 2023, the Group identified the following distinct
performance obligations: Early TCER Activities, Advanced TCER Activities and Database Activities. The most reasonable estimation method for the Early TCER Activities and the Database Activities is the adjusted market assessment approach, due to the
fact that we are able to use insights from prior collaborations as well as information implicit in the contract to estimate the stand-alone selling price. To estimate a stand-alone selling price for the performance obligation related to the Advanced
TCER Activities, we concluded to use the residual approach due to the fact that the license is a unique license and there is no available market price for the license and hence no specific stand-alone selling price apart from the residual amount was
identified. We evaluated each performance obligation to determine if it can be satisfied at a point in time or over time. The control over all performance obligations is satisfied over time. We transfer control of these agreed services over time and
will therefore recognize revenue over time as costs are incurred using a cost-to-cost method. For the Database Activities, we will recognize revenue linearly over time,
as the performance obligations represent a right to access the database. At inception of the Moderna agreement, the entire upfront payment was initially deferred on our Consolidated Statement of Financial Position.
Milestone payments are generally included in the transaction price at the amount stipulated in the respective agreement and recognized to the
extent that it is highly probable that a significant reversal in the amount of cumulative revenue recognized will not occur. To date, no milestone payment has been included in the transaction price and recognized into revenue.
We provide development and manufacturing work to our collaboration partners and recognize revenue over time using an input-based method to
measure progress toward complete satisfaction of the service, because the collaboration partner simultaneously receives and consumes the benefits provided. Forecast values are used for the calculation of expected future revenue for the remaining
term of the contract. These costs estimated as part of the budgeting process must be reviewed and approved before we can use them for recognition purposes. Significant management judgment is required to determine the level of effort required under
an arrangement, and the period over which we expect to complete our performance obligations under the arrangement which includes total internal personnel costs and external costs to be incurred. Changes in these estimates can have a material effect
on revenue recognized.
Share-based Compensation
The Company offers a share-based compensation plan that includes Performance-Based Options (PSUs) and service options including a
conversion of previous share-based compensation arrangements entered into by Immatics GmbH.
The costs of equity-settled transactions are
determined by the fair value at grant date, using an appropriate valuation model. Share-based expenses for the respective vesting periods, are recognized in research and development expenses and general and administrative expenses, reflecting a
corresponding increase in equity.
Income Taxes
Uncertainties exist with respect to the interpretation of complex tax regulations, changes in tax laws, and the amount and timing of future
taxable income. Given the wide range and complexity of existing contractual agreements, differences arising between the actual results and the assumptions made, or future changes to such assumptions, could necessitate future adjustments to tax
income and expenses already recorded. Deferred tax assets are recognized for unused tax losses to the extent that it is probable that taxable profit will be available which can be utilized against the losses. Significant management judgement is
required to determine the amount of deferred tax assets that can be recognized, based upon the likely timing and the level of future taxable profits together with future tax planning strategies. Due to our history of loss-making over the last
several years as well as our expectation for the foreseeable future, we have not recognized any deferred tax assets on tax losses carried forward despite the net income for the year ended December 31, 2023. Changes in the estimation of our
potential to use of tax losses carried forward can have a material effect on our net income.
Recently Issued and Adopted Accounting Pronouncement
New standards and interpretations applied for the first time as of January 1, 2024 and 2023 had no material effect on the consolidated
financial statements of the Group.
In April 2024, IFRS 18, Presentation and Disclosure in Financial Statements was issued to
achieve comparability of the financial performance of similar entities. The standard, which replaces IAS 1 Presentation of Financial Statements, impacts the presentation of primary financial statements and notes, including the statement
of earnings where companies will be required to present separate categories of income and expense for operating, investing, and financing activities with prescribed subtotals for each new category. The standard will also require management-defined
performance measures to be explained and included in a separate note within the consolidated financial statements.
The standard is
effective for annual reporting periods beginning on or after January 1, 2027, including interim financial statements, and requires retrospective application. The Company is currently assessing the impact of the new standard.
Quantitative and Qualitative Disclosures about Market Risk
We are exposed to various risks in relation to financial instruments. Our principal financial instruments comprise cash and cash equivalents,
short-term deposits and accounts receivables. The main purpose of these financial instruments is to invest the proceeds of capital contributions and upfront payments from collaboration agreements. We have various other financial instruments such as
other receivables and trade accounts payables, which arise directly from its operations.
The main risks arising from our financial
instruments are market risk and liquidity risk. The Board of Management reviews and agrees on policies for managing these risks as summarized below. We also monitor the market price risk arising from all financial instruments.
Interest rate risk
Our exposure to
changes in interest rates relates to investments in deposits and to changes in the interest for overnight deposits. Changes in the general level of interest rates may lead to an increase or decrease in the fair value of these investments. Regarding
the liabilities shown in the Consolidated Statement of Financial Position, we are currently not subject to major interest rate risks.
Credit risk
Financial instruments that potentially subject us to concentrations of credit and liquidity risk consist primarily of cash and cash
equivalents, accounts receivables and short-term deposits. Our cash and cash equivalents and short-term deposits are denominated in Euros and US Dollars and maintained with three financial institutions in Germany and two in the United States. Our
accounts receivables are denominated in Euros.
We continually monitor our positions with, and the credit quality of, the financial
institutions and corporation, which are counterparts to our financial instruments and we are not anticipating non-performance. The maximum default risk corresponds to the carrying amount of the financial
assets shown in the statement of financial position. We monitor the risk of a liquidity shortage. The main factors considered here are the maturities of financial assets, as well as expected cash flows from equity measures.
Currency risk
Currency risk shows the
risk that the value of a financial instrument will fluctuate due to changes in foreign exchange rates. In particular it poses a threat if the value of the currency in which liabilities are priced appreciates relative to the currency of the assets.
Our business transactions are generally conducted in Euros and U.S. dollars. We aim to match EUR cash inflows with EUR cash outflows and U.S. dollar cash inflows with U.S. Dollar cash outflows where possible. Our objective of currency risk
management is to identify, manage and control currency risk exposures within acceptable parameters.
Our cash and cash equivalents were 122.1 million as of March 31, 2024.
Approximately 78% of our cash and cash equivalents were held in Germany, of which approximately 84% were denominated in Euros and 16% were denominated in U.S. Dollars. The remainder of our cash and cash equivalents are held in the United States and
denominated in U.S. Dollars. Additionally, we have short-term deposits classified as Other financial assets denominated in Euros in the amount of 151.5 million and U.S. Dollars in the amount of 290.4 million as of
March 31, 2024.
Market risk and currency risk of warrants
Our activities expose us to the financial risks of changes in price of the warrants. As the warrants are recognized at fair value on the
consolidated statement of financial position of the Group, our exposure to market risks results from the volatility of the warrants price. The Warrants are publicly traded at the NASDAQ Stock Exchange. A reasonable increase (decrease) in the warrant
price by 10%, with all other variables held constant, would lead to a (loss) gain before tax of 1.8 million with a corresponding effect in the equity as of March 31, 2024.
OTHER INFORMATION
Legal Proceedings
From time to time, we may be subject to various legal proceedings and claims that arise in the ordinary course of our business activities.
TaurX has filed a trademark opposition against our registered Trademark IMTX in the EU. Discovery and preliminary procedural matters remain ongoing and the parties are engaged in settlement discussion. The results of litigation and claims cannot be
predicted with certainty. As of the date of this Report, we do not believe that we are party to any claim or litigation, the outcome of which would, individually or in the aggregate, be reasonably expected to have a material adverse effect on our
business.
Risk Factors
There
have been no material changes from the risk factors described in the section titled Risk Factors in our Annual Report.
Exhibit 99.2
PRESS RELEASE
Immatics Announces First Quarter 2024 Financial Results and Business Update
Company Provides Clinical Data Update from Ongoing Phase 1 Clinical Trial with
ACTengine® IMA203 TCR-T Targeting PRAME
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Updated clinical data on ACTengine® IMA203 targeting
PRAME in 30 heavily pre-treated metastatic melanoma patients at RP2D: 55% confirmed objective response rate, including tumor shrinkage achieved in 87% of patients; median duration of response of 13.5 months
including 11/16 ongoing confirmed responses; IMA203 continues to maintain a favorable safety profile |
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Registration-enabling randomized Phase 2/3 trial for
ACTengine® IMA203 in 2L+ melanoma planned to commence in 2024 following further discussions with FDA |
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Next data update on IMA203 and IMA203CD8 (GEN2) planned for 2H 2024 |
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First clinical data updates for Immatics next-generation, half-life extended TCR Bispecifics, TCER® IMA401 (MAGEA4/8) and TCER® IMA402 (PRAME), from ongoing Phase 1 dose escalation trials planned for 2H 2024; updates to include details on
safety, pharmacokinetics and initial anti-tumor activity |
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$201.5 million public offering completed on January 22, 2024 |
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Cash and cash equivalents as well as other financial assets amount to $609.7 million1 (564.0 million) as of March 31, 2024 funding company operations into 2027 |
Houston, Texas and Tuebingen, Germany, May 14, 2024 Immatics N.V. (NASDAQ: IMTX, Immatics), a
clinical-stage biopharmaceutical company active in the discovery and development of T cell-redirecting cancer immunotherapies, today provided a business update and reported financial results for the quarter ended March 31, 2024.
Our lead cell therapy candidate, IMA203, continues to show deep and durable responses in a significantly expanded data set since our last data readout
in November 2023. This update emphasizes the meaningful impact our novel immunotherapy may have on the lives of metastatic cutaneous, uveal and mucosal melanoma patients and the medical needs that IMA203 has a real opportunity to address. We
continue to plan to move IMA203 into a registration-enabling clinical trial within this year while also continuing to ramp up our commercial manufacturing buildout, said Harpreet Singh, Ph.D., CEO and
Co-Founder of Immatics. In addition to IMA203s progress, we also look forward to presenting the first clinical data on the two lead candidates from our bispecifics pipeline in the second half of
the year.
1 |
All amounts translated using the exchange rate published by the European Central Bank in effect as of
March 31, 2024 (1 EUR = 1.0811 USD). |
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Immatics Press Release May 14, 2024 |
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First Quarter 2024 and Subsequent Company Progress
ACTengine® Cell Therapy Program
ACTengine® IMA203 monotherapy
Today, Immatics is providing a data update on IMA203 monotherapy targeting PRAME from the ongoing Phase 1 trial at the recommended Phase 2 dose (RP2D, 1 to
10 billion total TCR-T cells) in 30 heavily pretreated metastatic melanoma patients evaluable for efficacy. The treated patient population is composed of patients with a median of 3 lines of prior
systemic treatments, consisting of cutaneous melanoma patients (N=17), uveal melanoma patients (N=10), mucosal melanoma patients (N=2) and a patient with melanoma of unknown primary (N=1). The current data represent an update to the previously
communicated interim data readout in the IMA203 melanoma efficacy population of November 8, 2023.
As of the data cut-off on April 25, 2024, treatment with IMA203 monotherapy in the efficacy population has demonstrated:
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Confirmed objective response rate (cORR) of 55% (16/29) |
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Disease control rate of 90% (27/30) |
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Tumor shrinkage in 87% (26/30) of patients |
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Median duration of response (mDOR) was 13.5 months (min 1.2+, max 21.5+ months) including 11 of 16 confirmed
objective responses ongoing at data cut-off and longest duration of response ongoing at >21 months after infusion |
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Confirmed response rates are similar across all melanoma subtypes (56% (9/16) in cutaneous melanoma; 54% (7/13)
in other melanoma subtypes) |
To date, IMA203 has maintained a favorable safety profile with no treatment-related grade 5 events in the
safety population (N=65 patients across all dose levels and all tumor types).
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Immatics Press Release May 14, 2024 |
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Best overall response for IMA203 at RP2D in melanoma
More information and details on the IMA203 clinical data update in melanoma are available in the Immatics corporate
presentation: https://investors.immatics.com/events-presentations
The next data update with translational and clinical data for IMA203 is planned
for 2H 2024 at a medical conference.
Immatics late-stage clinical cell therapy development is supported by its differentiated manufacturing related
to timeline, capabilities and facilities. ACTengine® IMA203 cell therapy products are manufactured within 7 days followed by a 7-day QC release testing
at a success rate of >95% to reach the target dose. The company has also recently completed construction of a ~100,000 square foot R&D and GMP manufacturing facility with a modular design for efficient and cost-effective scalability intended
to serve early-stage and Phase 2/3 clinical trials, as well as initial commercial supply. The new site will start GMP manufacturing of cell therapy products in early 2025. Meanwhile, the existing GMP facility, which is run in collaboration with UT
Health, will remain active until YE 2025 and will also initially serve the Phase 2/3 registrational trial.
Following an RMAT designation in October
2023 and productive interactions with the FDA, Immatics plans to initiate a randomized Phase 2/3 trial in 4Q 2024 for IMA203 in patients with second-line or later (2L+) cutaneous melanoma, potentially also including uveal melanoma patients.
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Immatics Press Release May 14, 2024 |
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The Phase 2/3 trial is expected to assess IMA203 targeting PRAME in HLA-A*02:01-positive cutaneous melanoma patients versus a control arm. This approach is consistent with the FDAs one-trial approach2, i.e., a single randomized controlled trial to support accelerated approval and the verification of clinical benefit to achieve full approval. The high prevalence of PRAME (≥95%) in cutaneous
melanoma may enable the company to enroll patients without PRAME pre-testing. This would enhance trial operations and would remove the need to develop a companion diagnostic for PRAME testing in this
indication. The full trial design is currently being developed and is subject to further alignment with the FDA as part of the ongoing discussions. Further details of the final clinical trial design will be provided in 2H 2024.
IMA203 is being developed to treat patients with metastatic melanoma, a prevalent cancer type with increasing incidence both inside and outside the United
States. Currently, eligible PRAME-positive melanoma patients for the ongoing trials, i.e., 2L+, HLA-A*02:01 positive, include ~3,000 cutaneous melanoma patients and ~300 eligible uveal melanoma patients3 in the US.
ACTengine® IMA203CD8 (GEN2)
monotherapy
As of the previously reported interim clinical update from November 8, 2023, the first data on the companys
second-generation product candidate, IMA203CD8 (consisting of PRAME-specific functional CD8+ and CD4+ cells), demonstrated 56% (5/9) cORR with enhanced pharmacology compared to IMA203. mDOR was not reached (min 2.0+ months, max 11.5+ months) at a
mFU of 4.8 months. As of the reported September 30, 2023 cut-off date, IMA203CD8 (GEN2) exhibited a manageable tolerability profile.
For IMA203CD8 (GEN2), Immatics cleared dose level 4a (DL4a, up to ~1.6x109
TCR-T cells) in December 2023. Immatics plans to continue dose escalation with the goal to define the optimal dose for further development. In addition to treating melanoma patients, Immatics has also started
to expand its clinical footprint outside of melanoma to address a broader patient population with a particular focus on ovarian and uterine cancers.
A
next data update for IMA203CD8 (GEN2) is planned for 2H 2024.
2 |
FDA Draft Guidance Clinical Trial Considerations To Support Accelerated Approval of Oncology Therapeutics
Guidance for Industry, March 2023 |
3 |
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) |
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Immatics Press Release May 14, 2024 |
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TCR Bispecifics Programs
Immatics T cell engaging receptor (TCER®) candidates are next-generation, half-life extended TCR
Bispecific molecules. They are designed to achieve a patient-convenient dosing schedule and to maximize efficacy while minimizing toxicities in patients through the proprietary format using a high-affinity TCR domain against the tumor target and a low-affinity T cell recruiter binding to the T cell.
Upcoming milestones for Immatics clinical TCER® pipeline
Immatics seeks to deliver clinical proof-of-concept for its novel TCER® platform as quickly as possible and plans to provide first clinical data for IMA401 (MAGEA4/8) and IMA402 (PRAME)
in 2H 2024.
Key objectives include:
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Demonstrating tolerability of the novel, next-generation, half-life extended TCR Bispecifics format;
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Optimizing dosing schedule to a less frequent regimen during dose escalation, based on pharmacokinetics data;
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Demonstrating initial clinical anti-tumor activity (i.e., confirmed objective responses according to RECIST 1.1).
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TCER® IMA401 (MAGEA4/8)
The Phase 1 dose escalation basket trial to evaluate safety, tolerability and initial anti-tumor activity of
TCER® IMA401 in patients with recurrent and/or refractory solid tumors is ongoing. IMA401 targets an
HLA-A*02:01-presented peptide that occurs identically in two different proteins, MAGEA4 and MAGEA8. This target peptide has been selected based on natural expression in
native solid tumors at particularly high target density (peptide copy number per tumor cell identified by Immatics proprietary quantitative mass spectrometry engine XPRESIDENT® is >5x
higher than for a MAGEA4 peptide target used in other clinical trials).
MAGEA4 and MAGEA8 are expressed in multiple solid cancers including lung cancer,
head and neck cancer, melanoma, ovarian cancer, sarcoma and others. Tolerability continues to be manageable with transient low-grade CRS, lymphopenia and neutropenia at high doses, all of which are expected
for a bispecific T cell engager. A premedication with low doses of dexamethasone administered prior to the first 4 infusions, as used with other approved bispecific products, has been implemented as a preventative measure for continued dose
escalation. Since the implementation of this premedication, to date, no cases of high-grade neutropenia among the patients treated have been observed. Based on pharmacokinetics data, the treatment schedule for IMA401 was switched from weekly to
bi-weekly dosing. Confirmed objective responses have been observed in multiple patients.
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Immatics Press Release May 14, 2024 |
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IMA401 is being developed in collaboration with Bristol Myers Squibb. First clinical data in at least 25
patients in dose escalation across all doses and multiple solid cancers is expected to be announced in 2H 2024.
TCER® IMA402 (PRAME)
Immatics initiated the Phase 1/2 trial investigating the
companys fully owned TCER® candidate IMA402 in patients with recurrent and/or refractory solid tumors in August 2023 and the first patients have been dosed. Initial focus indications are
ovarian cancer, lung cancer, uterine cancer and cutaneous and uveal melanoma, among others. IMA402 targets an HLA-A*02:01-presented peptide derived from the tumor
antigen PRAME. This target peptide has been selected based on natural expression in native solid primary tumors and metastases at particularly high target density (peptide copy number per tumor cell identified by Immatics proprietary
quantitative mass spectrometry engine XPRESIDENT®).
Immatics has recently engaged Patheon UK
Limited, a subsidiary of ThermoFisher Scientific Inc., for the manufacturing of clinical IMA402 batches for its use within a potential registration-enabling trial. Patient recruitment and dose escalation continue to scale. First clinical data in at
least 15 patients in dose escalation across multiple solid cancers, but initially focused on melanoma, is anticipated to be announced in 2H 2024.
Corporate Development
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On January 22, 2024, Immatics completed an offering of 18,313,750 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, were approximately $201.5 million. |
First Quarter 2024 Financial Results
Cash
Position: Cash and cash equivalents as well as other financial assets total 564.0 million ($609.7 million1) as of March 31, 2024, compared to 425.9 million ($460.4
million1) as of December 31, 2023. The increase is mainly due to the public offering in January 2024, partly offset by ongoing research and development activities. The company projects a cash
runway into 2027.
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Immatics Press Release May 14, 2024 |
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6 | 14 |
Revenue: Total revenue, consisting of revenue from collaboration agreements, was
30.3 million ($32.8 million1) for the three months ended March 31, 2024, compared to 9.8 million ($10.6 million1)
for the three months ended March 31, 2023. The increase is mainly the result of the release of the deferred revenue following the termination of the Genmab collaboration.
Research and Development Expenses: R&D expenses were 32.1 million ($34.7 million1)
for the three months ended March 31, 2024, compared to 27.6 million ($29.8 million1) for the three months ended March 31, 2023. The increase mainly resulted from costs
associated with the advancement of the clinical pipeline candidates.
General and Administrative Expenses: G&A expenses were
11.6 million ($12.5 million1) for the three months ended March 31, 2024, compared to 9.6 million ($10.4 million1)
for the three months ended March 31, 2023.
Net Profit and Loss: Net loss was 3.1 million ($3.4 million1) for the three months ended March 31, 2024, compared to a net loss of 19.7 million ($21.3 million1) for the three months ended
March 31, 2023. The decrease of net loss resulted mainly from the one-time revenue related to the termination of the Genmab collaboration as reported previously.
Full financial statements can be found in the 6-K filed with the Securities and Exchange Commission (SEC) on
May 14, 2024 and published on the SEC website under www.sec.gov.
Upcoming Investor Conferences
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Bank of America Health Care Conference, Las Vegas (NV) May 14 - 16, 2024 |
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Jefferies Global Healthcare Conference, New York (NY) June 5 - 7, 2024 |
To see the full list of events and presentations, visit www.investors.immatics.com/events-presentations.
- END-
About IMA203 and target PRAME
ACTengine® IMA203 T cells are directed against an HLA-A*02-presented peptide derived from preferentially expressed antigen in melanoma (PRAME), a protein frequently expressed in a large variety of solid cancers, thereby supporting the programs
potential to address a broad cancer patient population. Immatics PRAME peptide is present at a high copy number per tumor cell and is homogeneously and specifically expressed in tumor tissue. The peptide has been identified and characterized
by Immatics proprietary mass spectrometry-based target discovery platform, XPRESIDENT®. Through its proprietary TCR discovery and engineering platform XCEPTOR®, Immatics has generated a highly specific T cell receptor (TCR) against this target for its TCR-based cell therapy approach, ACTengine® IMA203.
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Immatics Press Release May 14, 2024 |
|
7 | 14 |
ACTengine® IMA203
TCR-T is currently being evaluated in Phase 1 IMA203 monotherapy, and IMA203CD8 (GEN2) monotherapy, where IMA203 engineered T cells are co-transduced with a CD8ab co-receptor. As previously reported, IMA203 in combination with an immune checkpoint inhibitor has been deprioritized.
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.
Immatics intends to use its website www.immatics.com as a means of disclosing material non-public information. For regular updates you can also follow us on X, Instagram and LinkedIn.
Forward-Looking Statements
Certain statements in this
press release may be considered forward-looking statements. Forward-looking statements generally relate to future events or the Companys future financial or operating performance. For example, statements concerning timing of data read-outs for
product candidates, the timing, outcome and design 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 Companys 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 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 managements control including general economic conditions and other risks, uncertainties and factors set forth in the Companys Annual Report on
Form 20-F and other filings with the
|
|
|
Immatics Press Release May 14, 2024 |
|
8 | 14 |
Securities and Exchange Commission (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. The Company undertakes no duty to update
these forward-looking statements. All the scientific and clinical data presented within this press release 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.
For more information, please contact:
Media
Trophic Communications
Phone: +49 171 3512733
immatics@trophic.eu
Immatics N.V.
Jordan Silverstein
Head of Strategy
Phone: +1 346
319-3325
InvestorRelations@immatics.com
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|
Immatics Press Release May 14, 2024 |
|
9 | 14 |
Immatics N.V. and subsidiaries
Condensed Consolidated Statement of Loss of Immatics N.V.
|
|
|
|
|
|
|
|
|
|
|
Three months ended March 31, |
|
|
|
2024 |
|
|
2023 |
|
|
|
(Euros in thousands, except
per share data) |
|
Revenue from collaboration agreements |
|
|
30,269 |
|
|
|
9,796 |
|
Research and development expenses |
|
|
(32,108 |
) |
|
|
(27,581 |
) |
General and administrative expenses |
|
|
(11,642 |
) |
|
|
(9,586 |
) |
Other income |
|
|
12 |
|
|
|
941 |
|
|
|
|
|
|
|
|
|
|
Operating result |
|
|
(13,469 |
) |
|
|
(26,430 |
) |
Change in fair value of liabilities for warrants |
|
|
1,043 |
|
|
|
7,397 |
|
Other financial income |
|
|
11,381 |
|
|
|
2,795 |
|
Other financial expenses |
|
|
(677 |
) |
|
|
(3,509 |
) |
|
|
|
|
|
|
|
|
|
Financial result |
|
|
11,747 |
|
|
|
6,683 |
|
|
|
|
|
|
|
|
|
|
Loss before taxes |
|
|
(1,722 |
) |
|
|
(19,747 |
) |
Taxes on income |
|
|
(1,332 |
) |
|
|
|
|
Net loss |
|
|
(3,054 |
) |
|
|
(19,747 |
) |
|
|
|
|
|
|
|
|
|
Net loss per share: |
|
|
|
|
|
|
|
|
Basic |
|
|
(0.03 |
) |
|
|
(0.26 |
) |
Diluted |
|
|
(0.04 |
) |
|
|
(0.26 |
) |
|
|
|
Immatics Press Release May 14, 2024 |
|
10 | 14 |
Immatics N.V. and subsidiaries
Condensed Consolidated Statement of Comprehensive Loss of Immatics N.V.
|
|
|
|
|
|
|
|
|
|
|
Three months ended March 31, |
|
|
|
2024 |
|
|
2023 |
|
|
|
(Euros in thousands) |
|
Net loss |
|
|
(3,054 |
) |
|
|
(19,747 |
) |
Other comprehensive income |
|
|
|
|
|
|
|
|
Items that may be reclassified subsequently to profit or loss |
|
|
|
|
|
|
|
|
Currency translation differences from foreign operations |
|
|
336 |
|
|
|
564 |
|
|
|
|
|
|
|
|
|
|
Total comprehensive loss for the year |
|
|
(2,718 |
) |
|
|
(19,183 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
Immatics Press Release May 14, 2024 |
|
11 | 14 |
Immatics N.V. and subsidiaries
Condensed Consolidated Statement of Financial Position of Immatics N.V.
|
|
|
|
|
|
|
|
|
|
|
As of |
|
|
|
March 31, 2024 |
|
|
December 31, 2023 |
|
|
|
(Euros in thousands) |
|
Assets |
|
|
|
|
|
|
|
|
Current assets |
|
|
|
|
|
|
|
|
Cash and cash equivalents |
|
|
122,093 |
|
|
|
218,472 |
|
Other financial assets |
|
|
441,857 |
|
|
|
207,423 |
|
Accounts receivables |
|
|
1,781 |
|
|
|
4,093 |
|
Other current assets |
|
|
22,666 |
|
|
|
19,382 |
|
|
|
|
|
|
|
|
|
|
Total current assets |
|
|
588,397 |
|
|
|
449,370 |
|
Non-current assets |
|
|
|
|
|
|
|
|
Property, plant and equipment |
|
|
49,968 |
|
|
|
43,747 |
|
Intangible assets |
|
|
1,501 |
|
|
|
1,523 |
|
Right-of-use
assets |
|
|
11,886 |
|
|
|
13,308 |
|
Other non-current assets |
|
|
1,373 |
|
|
|
2,017 |
|
|
|
|
|
|
|
|
|
|
Total non-current assets |
|
|
64,728 |
|
|
|
60,595 |
|
|
|
|
|
|
|
|
|
|
Total assets |
|
|
653,125 |
|
|
|
509,965 |
|
|
|
|
|
|
|
|
|
|
Liabilities and shareholders equity |
|
|
|
|
|
|
|
|
Current liabilities |
|
|
|
|
|
|
|
|
Provisions |
|
|
1,740 |
|
|
|
|
|
Accounts payables |
|
|
20,537 |
|
|
|
25,206 |
|
Deferred revenue |
|
|
96,525 |
|
|
|
100,401 |
|
Liabilities for warrants |
|
|
17,950 |
|
|
|
18,993 |
|
Lease liabilities |
|
|
2,762 |
|
|
|
2,604 |
|
Other current liabilities |
|
|
9,590 |
|
|
|
9,348 |
|
|
|
|
|
|
|
|
|
|
Total current liabilities |
|
|
149,104 |
|
|
|
156,552 |
|
Non-current liabilities |
|
|
|
|
|
|
|
|
Deferred revenue |
|
|
91,358 |
|
|
|
115,527 |
|
Lease liabilities |
|
|
11,877 |
|
|
|
12,798 |
|
Other non-current liabilities |
|
|
|
|
|
|
4 |
|
|
|
|
|
|
|
|
|
|
Total non-current liabilities |
|
|
103,235 |
|
|
|
128,329 |
|
Shareholders equity |
|
|
|
|
|
|
|
|
Share capital |
|
|
1,031 |
|
|
|
847 |
|
Share premium |
|
|
1,001,402 |
|
|
|
823,166 |
|
Accumulated deficit |
|
|
(600,347 |
) |
|
|
(597,293 |
) |
Other reserves |
|
|
(1,300 |
) |
|
|
(1,636 |
) |
|
|
|
|
|
|
|
|
|
Total shareholders equity |
|
|
400,768 |
|
|
|
225,084 |
|
|
|
|
|
|
|
|
|
|
Total liabilities and shareholders equity |
|
|
653,125 |
|
|
|
509,965 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Immatics Press Release May 14, 2024 |
|
12 | 14 |
Immatics N.V. and subsidiaries
Condensed Consolidated Statement of Cash Flows of Immatics N.V.
|
|
|
|
|
|
|
|
|
|
|
Three months ended March 31, |
|
|
|
2024 |
|
|
2023 |
|
|
|
(Euros in thousands) |
|
Cash flows from operating activities |
|
|
|
|
|
|
|
|
Net profit/(loss) |
|
|
(3,054 |
) |
|
|
(19,747 |
) |
Taxes on income |
|
|
1,332 |
|
|
|
|
|
Profit/(loss) before tax |
|
|
(1,722 |
) |
|
|
(19,747 |
) |
Adjustments for: |
|
|
|
|
|
|
|
|
Interest income |
|
|
(6,294 |
) |
|
|
(2,254 |
) |
Depreciation and amortization |
|
|
3,014 |
|
|
|
1,811 |
|
Interest expenses |
|
|
194 |
|
|
|
195 |
|
Equity-settled share-based payment |
|
|
4,297 |
|
|
|
6,103 |
|
Net foreign exchange differences and expected credit losses |
|
|
(4,553 |
) |
|
|
3,143 |
|
Change in fair value of liabilities for warrants |
|
|
(1,043 |
) |
|
|
(7,397 |
) |
Changes in: |
|
|
|
|
|
|
|
|
Decrease/(increase) in accounts receivables |
|
|
2,312 |
|
|
|
880 |
|
Decrease/(increase) in other assets |
|
|
574 |
|
|
|
234 |
|
(Decrease)/increase in deferred revenue, accounts payables and other liabilities |
|
|
(31,674 |
) |
|
|
(7,793 |
) |
Interest received |
|
|
2,484 |
|
|
|
1,189 |
|
Interest paid |
|
|
(194 |
) |
|
|
(79 |
) |
Income tax paid |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net cash (used in)/provided by operating activities |
|
|
(32,605 |
) |
|
|
(23,715 |
) |
|
|
|
|
|
|
|
|
|
Cash flows from investing activities |
|
|
|
|
|
|
|
|
Payments for property, plant and equipment |
|
|
(9,174 |
) |
|
|
(4,317 |
) |
Payments for intangible assets |
|
|
(2 |
) |
|
|
(8 |
) |
Proceeds from disposal of property, plant and equipment |
|
|
|
|
|
|
|
|
Payments for investments classified in Other financial assets |
|
|
(290,599 |
) |
|
|
(67,735 |
) |
Proceeds from maturity of investments classified in Other financial assets |
|
|
57,957 |
|
|
|
68,341 |
|
|
|
|
|
|
|
|
|
|
Net cash (used i n)/provided by investing activities |
|
|
(241,818 |
) |
|
|
(3,719 |
) |
|
|
|
|
|
|
|
|
|
Cash flows from financing activities |
|
|
|
|
|
|
|
|
Proceeds from issuance of shares to equity holders |
|
|
185,669 |
|
|
|
|
|
Transaction costs deducted from equity |
|
|
(11,548 |
) |
|
|
|
|
Payments related to lease liabilities |
|
|
524 |
|
|
|
(866 |
) |
|
|
|
|
|
|
|
|
|
Net cash provided by/(used in) financing activities |
|
|
174,645 |
|
|
|
(866 |
) |
|
|
|
|
|
|
|
|
|
Net (decrease)/increase in cash and cash equivalents |
|
|
(99,778 |
) |
|
|
(28,300 |
) |
|
|
|
|
|
|
|
|
|
Cash and cash equivalents at beginning of the year |
|
|
218,472 |
|
|
|
148,519 |
|
|
|
|
|
|
|
|
|
|
Effects of exchange rate changes and expected credit losses on cash and cash equivalents |
|
|
3,399 |
|
|
|
(2,300 |
) |
|
|
|
|
|
|
|
|
|
Cash and cash equivalents at end of the year |
|
|
122,093 |
|
|
|
117,919 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Immatics Press Release May 14, 2024 |
|
13 | 14 |
Immatics N.V. and subsidiaries
Condensed Consolidated Statement of Changes in Shareholders equity of Immatics N.V.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(Euros in thousands) |
|
Share capital |
|
|
Share premium |
|
|
Accumulated deficit |
|
|
Other reserves |
|
|
Total share- holders equity |
|
Balance as of January 1, 2023 |
|
|
767 |
|
|
|
714,177 |
|
|
|
(500,299 |
) |
|
|
(1,481 |
) |
|
|
213,164 |
|
Other comprehensive income |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
564 |
|
|
|
564 |
|
Net loss |
|
|
|
|
|
|
|
|
|
|
(19,747 |
) |
|
|
|
|
|
|
(19,747 |
) |
Comprehensive loss for the year |
|
|
|
|
|
|
|
|
|
|
(19,747 |
) |
|
|
564 |
|
|
|
(19,183 |
) |
Equity-settled share-based compensation |
|
|
|
|
|
|
6,103 |
|
|
|
|
|
|
|
|
|
|
|
6,103 |
|
Share options exercised |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Issue of share capital net of transaction costs |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance as of March 31, 2023 |
|
|
767 |
|
|
|
720,280 |
|
|
|
(520,046 |
) |
|
|
(917 |
) |
|
|
200,084 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance as of January 1, 2024 |
|
|
847 |
|
|
|
823,166 |
|
|
|
(597,293 |
) |
|
|
(1,636 |
) |
|
|
225,084 |
|
Other comprehensive income |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
336 |
|
|
|
336 |
|
Net loss |
|
|
|
|
|
|
|
|
|
|
(3,054 |
) |
|
|
|
|
|
|
(3,054 |
) |
Comprehensive loss for the year |
|
|
|
|
|
|
|
|
|
|
(3,054 |
) |
|
|
336 |
|
|
|
(2,718 |
) |
Equity-settled share-based compensation |
|
|
|
|
|
|
4,297 |
|
|
|
|
|
|
|
|
|
|
|
4,297 |
|
Share options exercised |
|
|
1 |
|
|
|
682 |
|
|
|
|
|
|
|
|
|
|
|
683 |
|
Issue of share capital net of transaction costs |
|
|
183 |
|
|
|
173,257 |
|
|
|
|
|
|
|
|
|
|
|
173,440 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance as of March 31, 2024 |
|
|
1,031 |
|
|
|
1,001,402 |
|
|
|
(600,347 |
) |
|
|
(1,300 |
) |
|
|
400,786 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Immatics Press Release May 14, 2024 |
|
14 | 14 |
Immatics Corporate Presentation May
14, 2024 Exhibit 99.3
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, outcome and design 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 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 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.
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 Intro Differentiated Platforms Unique technologies to identify true cancer targets and right TCRs Clinical PoC for Cell Therapy High confirmed objective response rate and durable responses in melanoma; registration-enabling trial in
preparation
Upcoming 2024 Catalysts for
ACTengine® and TCER® Clinical Lead Assets Projected Cash Runway into 2027 to Reach Multiple Value Inflections Points Targeted randomized Phase 2/3 trial1 for ACTengine® IMA203 in 2L+ melanoma in 2024 Next data updates for IMA203 &
IMA203CD8 (GEN2) planned in 2H 2024 ACTengine® IMA203 / IMA203CD8 (PRAME) First clinical data update from dose escalation in ongoing Phase 1 trial planned in 2H 2024 TCER® IMA401 (MAGEA4/8) First clinical data update from dose escalation
in ongoing Phase 1/2 trial planned in 2H 2024 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 1 This
trial will be designed consistent with the FDA’s “one-trial” approach (FDA Draft Guidance “Clinical Trial Considerations To Support Accelerated Approval of Oncology Therapeutics – Guidance for Industry,” March
2023), i.e., a single randomized controlled trial to support accelerated approval and the verification of clinical benefit to achieve full approval. The high prevalence of PRAME (≥95%) in cutaneous melanoma may enable enrollment of patients
without PRAME pre-testing and could remove the need to develop a companion diagnostic in this indication. The full trial design is currently being developed and is subject to further alignment with the FDA as part of the ongoing discussions.
Two Distinct TCR-based Therapeutic
Modalities in Clinical Development Differentiated positioning of ACTengine® vs. TCER® based on patient population and medical need Intro 1 Interim data update from the ACTengine® IMA203 (published May 14, 2024) and IMA203CD8
monotherapies (published November 08, 2023) Autologous TCR-T (ACTengine®) TCR Bispecifics (TCER®) Strong clinical activity in patients with high tumor burden1 Single dose 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, medium to high copy numbers
Modality Product Candidate Target
Preclinical Phase 1a1 Phase 1b1 Phase 2 Phase 3 Autologous ACT ACTengine® IMA203 PRAME ACTengine® IMA203CD8 PRAME ACTengine® IMA204 COL6A3 Autologous ACT 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 Multiple programs3 Undisclosed Our Pipeline of TCR-based Adoptive Cell Therapies
and Bispecifics Intro 1 Phase 1a: Dose escalation, Phase 1b: Dose expansion; 2 Immatics’ proprietary ACTallo® platform utilizing Editas’ CRISPR gene editing technology; 3 mRNA-enabled in vivo expressed TCER® molecules 2
Realizing the Full Multi-Cancer
Opportunity of PRAME ACTengine® IMA203 (TCR-T) and TCER® IMA402 (TCR Bispecific) 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 Phase 2/3 trial in preparation
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 expression 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
patients1 Uterine Carcinoma Uterine Carcinosarcoma Sarcoma Subtypes Cut. Melanoma Uveal Melanoma2 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
The Multi-Cancer Opportunity of PRAME
One of the Most Promising Solid Tumor Targets for TCR-based Therapies Known To Date High prevalence High target density Homogeneous expression “Clean” expression profile Clinical proof-of-concept sqNSCLC 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 non-small cell lung cancer IMA203
ACTengine® IMA203 Targeting
PRAME – Mechanism of Action Immatics’ Leading TCR-T Approach IMA203 LEUKAPHARESIS
ACTengine® IMA203 TCR-T
Product Manufacturing Differentiated Manufacturing Process and Setup 1-week manufacturing process followed by 1-week QC release testing High manufacturing success rate of >95% to reach IMA203 target dose* Lean and cost-efficient process
Proprietary Manufacturing Process IMA203 SHORT SIMPLE ROBUST *IMA203: RP2D 1-10x109 total TCR-T cells Manufacturing of ACTengine® candidates & other future autologous /allogeneic candidates Construction completed in 2024 ~100,000 sq ft in
Houston area, TX – modular design for efficient and cost-effective scalability Early-stage and registration-directed clinical trials as well as initial commercial supply State-of-the-art Research & GMP Manufacturing Facility
ACTengine® IMA203/IMA203CD8
TCR-T Monotherapy – Patient Flow 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® mRNA assay using Immatics’ MS-guided threshold; Biopsy or archived tissue Low dose IL-2** Safety and efficacy monitoring for 12 months Leukapheresis x x 1 3 2 Short process time of 14 days * 30
mg/m2 Fludarabine and 500 mg/m2 Cyclophosphamide 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
Melanoma Efficacy Population3
(N=30) ACTengine® IMA203 TCR-T Trial in Advanced Solid Tumors Data cut-off Apr 25, 2024 Heavily Pretreated Patient Population IMA203 Phase 1a Dose Escalation Dose Level 1-4 (total Safety Pop. N=281) Total Safety Population (N=651,2) Phase 1b
Dose Expansion Dose Level 4/5 (total Safety Pop. N=372) RP2D defined at 1-10x109 TCR-T cells (DL4/5) Melanoma patients at RP2D Total Safety Population Melanoma Efficacy Population3 All Comers (Phase 1a and Phase 1b) Melanoma (at RP2D)
Number of patients Total: N=651,2 Total: N=30 Cutaneous melanoma: N=17 Uveal melanoma: N=10 Melanoma of unknown primary: N=1 Mucosal melanoma: N=2 Prior lines of systemic treatment (median, min, max) Thereof CPI (melanoma only) (median,
min, max) 3 (0, 10) 2 (0, 4) 3 (0, 7) 2 (0, 4) LDH at baseline >1 x ULN [% of patients] 64.6 63.3 Baseline tumor burden Median Target lesion sum of diameter [mm] (min, max) 117.5 (15.0, 309.8) 107.5 (15.0, 309.8) Liver/Brain Lesions at
Baseline [% of patients] 63.1 70.0 Dose level DL1-5 DL4/5 For comprehensive patient flow chart, see appendix 1 One patient started lymphodepletion but did not receive IMA203 TCR-T cells; 2 One additional patient who received IMA203 TCR-T cells
shortly before data cut-off is not included; 3 Patients with at least one available tumor response assessment post infusion; RP2D: Recommended Phase 2 Dose of 1-10x109 total TCR-T cells; CPI: Checkpoint inhibitors; IMA203 DL4: 0.2-1.2x109 TCR-T
cells/m2 BSA, IMA203 DL5: 1.201 - 4.7x109 TCR-T cells/m2 BSA
Adverse event (System organ class,
Preferred term) ≥ Grade 3 No. % table continued… Nervous system disorders 2 3.1 Headache 1 1.5 Posterior reversible encephalopathy syndrome 1 1.5 Endocrine disorders 1 1.5 Inappropriate antidiuretic hormone secretion 1 1.5 Hepatobiliary
disorders 1 1.5 Cholangitis 1 1.5 Immune system disorders 1 1.5 Haemophagocytic lymphohistiocytosis 1 1.5 Reproductive system and breast disorders 1 1.5 Vaginal haemorrhage 1 1.5 Adverse event (System organ class, Preferred term) ≥ Grade 3 No.
% Patients with any adverse event 65 100.0 Adverse Events of Special Interest 10 15.4 Cytokine release syndrome 9 13.8 ICANS3 3 4.6 Blood and lymphatic system disorders 65 100.0 Neutropenia 57 87.7 Leukopenia 35 53.8 Anaemia 34 52.3 Lymphopenia 33
50.8 Thrombocytopenia 25 38.5 Febrile neutropenia 2 3.1 Cytopenia 1 1.5 Leukocytosis 1 1.5 Infections and infestations 10 15.4 Urinary tract infection 2 3.1 Appendicitis 1 1.5 COVID-19 1 1.5 Cytomegalovirus infection reactivation 1 1.5 Enterococcal
infection 1 1.5 Human herpesvirus 6 encephalitis 1 1.5 Infection 1 1.5 Orchitis 1 1.5 Sepsis4,5 1 1.5 Septic shock4 1 1.5 Investigations 10 15.4 Alanine aminotransferase increased 6 9.2 Aspartate aminotransferase increased 5 7.7 Blood creatinine
increased 2 3.1 Blood alkaline phosphatase increased 1 1.5 Blood bilirubin increased 1 1.5 Blood fibrinogen decreased 1 1.5 Lymphocyte count increased 1 1.5 Respiratory, thoracic and mediastinal disorders 10 15.4 Hypoxia 5 7.7 Pleural effusion 2 3.1
Bronchial obstruction 1 1.5 Dyspnoea 1 1.5 Epistaxis 1 1.5 Laryngeal inflammation 1 1.5 Respiratory failure 1 1.5 Adverse event (System organ class, Preferred term) ≥ Grade 3 No. % table continued… Metabolism and nutrition disorders 7
10.8 Hypokalaemia 3 4.6 Hyponatraemia 3 4.6 Hypophosphataemia 2 3.1 Dehydration 1 1.5 Failure to thrive 1 1.5 Vascular disorders 6 9.2 Hypertension 5 7.7 Hypotension 1 1.5 Gastrointestinal disorders 5 7.7 Abdominal pain 3 4.6 Diarrhoea 1 1.5 Ileus 1
1.5 Vomiting 1 1.5 General disorders and administration site conditions 4 6.2 Fatigue 1 1.5 General physical health deterioration4 1 1.5 Pyrexia 1 1.5 Swelling face 1 1.5 Renal and urinary disorders 4 6.2 Acute kidney injury6 2 3.1 Nephritis 1 1.5
Proteinuria 1 1.5 Skin and subcutaneous tissue disorders 4 6.2 Rash maculo-papular 3 4.6 Eczema 1 1.5 Cardiac disorders 2 3.1 Atrial fibrillation7 2 3.1 Eye disorders 2 3.1 Periorbital oedema 1 1.5 Ulcerative keratitis 1 1.5 Injury, poisoning and
procedural complications 2 3.1 Humerus fracture 1 1.5 Infusion related reaction 1 1.5 Musculoskeletal and connective tissue disorders 2 3.1 Back pain 1 1.5 Muscle spasms 1 1.5 Safety Profile of IMA203 across All Dose Levels in Phase 1a/b All
≥Grade 3 Adverse Events (N=651,2) All treatment-emergent adverse events (TEAEs) with ≥ Grade 3 regardless of relatedness to study treatment. 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 Cytokine release syndrome 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 (25-Apr-2024); 1 One additional patient who received IMA203 TCR-T cells shortly before data cut-off is not included; no
grade ≥3 serious adverse events were reported for this patient in the safety database at data cut-off; 2 Two patients with disease progression after first IMA203 infusion received exploratory second IMA203 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; 3 ICANS: Immune effector cell-associated neurotoxicity syndrome; 4 Fatal Adverse events were not considered related to any study drug; 5 Patient died from sepsis of unknown origin and did not receive IMA203 TCR-T cells; 6 One
additional case of acute kidney injury without severity grading entered in eCRF at data cut-off; 7 DLT: Dose limiting toxicity in phase 1a at DL2 reported on March 17, 2021. TEAEs by maximum severity for all patients in Phase 1a and Phase 1b
(N=651,2) Data cut-off Apr 25, 2024 IMA203 Favorable safety profile at doses as high as ~10x109 TCR-T cells Mostly mild to moderate CRS Infrequent ICANS (6.2% Gr1, 4.6% Gr2, 4.6% Gr3) No IMA203-related Grade 5 Adverse Events Full IMA203 monotherapy
safety profile is generally consistent with safety in melanoma subset
Best Overall Response for IMA203
Objective Responses in Heavily Pretreated Melanoma Patients at RP2D Data cut-off Apr 25, 2024 IMA203 cORR 55% (16/29) median DOR 13.5 months min, max DOR 1.2+, 21.5+ months 11/16 confirmed responses ongoing ORR 67% (20/30) Tumor shrinkage* 87%
(26/30) DCR (at week 6) 90% (27/30) *Tumor shrinkage of target lesions; 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 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; PD: Progressive Disease; SD: Stable Disease; PR: Partial
Response; cPR: Confirmed Partial Response; DCR: Disease control rate; RP2D: Recommended Phase 2 Dose of 1-10x109 total TCR-T cells; BL: Baseline ongoing
Response over Time of IMA203
Durable Responses 20+ Months after Treatment in Heavily Pretreated Melanoma Patients at RP2D Data cut-off Apr 25, 2024 IMA203 Scans at approximately week 6, month 3 and then every 3 months Ongoing cORR 55% (16/29) median DOR 13.5 months min, max DOR
1.2+, 21.5+ months 11/16 confirmed responses ongoing ORR 67% (20/30) Tumor shrinkage* 87% (26/30) DCR (at week 6) 90% (27/30) *Tumor shrinkage of target lesions; 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 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; PD: Progressive Disease; SD: Stable Disease; PR: Partial Response; cPR: Confirmed Partial Response; DCR: Disease control rate; RP2D: Recommended Phase 2 Dose of 1-10x109 total TCR-T cells; BL: Baseline
ACTengine® IMA203 TCR-T
Monotherapy Targeting PRAME in Melanoma Summary of Clinical Data and Planned Next Steps Next Steps Ongoing alignment with FDA on trial design of the randomized Phase 2/3 trial in 2L+ melanoma to start in 2024 Safety Anti-Tumor Activity
Durability RP2D Broad Reach Favorable safety profile: mostly mild to moderate CRS; infrequent ICANS (6.2% Gr1, 4.6% Gr2, 4.6% Gr3); no treatment related deaths 55% (16/29) cORR and 90% (27/30) DCR 13.5 months mDOR and ongoing responses at 20+ months
RP2D defined at 1-10x109 total TCR-T cells FDA RMAT designation received in multiple PRAME expressing cancers including cutaneous and uveal melanoma IMA203 Data cut-off Apr 25, 2024
High Unmet 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 US1 ~300 HLA-A*02:01 and PRAME-positive uveal melanoma patients annually in the US2 Favorable safety profile mostly mild
to moderate CRS, infrequent ICANS (6.2% Gr1, 4.6% Gr2, 4.6% Gr3), no treatment related deaths 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 prevalence 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 prevalence 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 Apr 25, 2024 IMA203 in Melanoma Targeted to Enter Randomized Phase 2/3 Trial
in 2L+ Melanoma in 2024 IMA203
IMA203CD8 GEN2 – IMA203 TCR-T
Monotherapy Leveraging CD8 and CD4 cells Differentiated Pharmacology Compared to 1st-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 CD8αβ 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 studies1 Data from CD19 CAR-T-treated leukaemia patients suggest a relevant role of engineered CD4 T cells in long-term durability2 TUMOR CELL DEATH CD4 T CELL Cytotoxic Activity
CD8 T CELL T cell Help Cytotoxic Activity 1Internal data not shown here, published in Bajwa et al. 2021 Journal for Immunotherapy of Cancer; 2 Melenhorst 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 2nd addition of tumor cells 3rd 4th 5th 6th 2nd addition of tumor cells 3rd 4th 5th 6th IMA203CD8
IMA203CD8 (GEN2) – Overview
of Patient Characteristics * Patients with at least one available tumor response assessment post infusion; IMA203CD8 DL3: 0.2-0.48x109 TCR-T cells/m2 BSA, IMA203CD8 DL4a: 0.481-0.8x109 TCR-T cells/m2 BSA, IMA203CD8 DL4b: 0.801-1.2x109 TCR-T
cells/m2; 1 DL4a cleared in Dec 2023 All Comers Efficacy population* N=12 Prior lines of systemic treatment (median, min, max) 3 (1, 5) LDH at baseline >1 x ULN [% of patients] 50.0 Baseline tumor burden Median target lesion sum of diameter
[mm] (min, max) 79.8 (20.0, 182.0) Dose level DL3/DL4a/DL4b Data cut-off Sep 30, 2023 Data cut-off as of Sep 30, 2023 Phase 1b Dose Expansion (N=12) DL 3/4a/4b DL4a cleared 1 IMA203CD8
Tolerability Data – IMA203CD8
(GEN2) 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 (N=12) Manageable tolerability Most frequent ≥Grade 3 AEs were expected cytopenia
associated with lymphodepletion No IMA203CD8-related Grade 5 Adverse Events1 Dose escalation ongoing Data cut-off Sep 30, 2023 1 Subsequent to data cut-off a Grade 5 event, possibly related to treatment, was observed. The patient’s immediate
cause of death was considered to be fatal sepsis, aggravated by the immunosuppression, a high-grade Immune Effector Cell-Associated Hemophagocytic Lymphohistiocytosis-Like Syndrome (IEC-HS), and the fast-progressing disease. IMA203CD8
IMA203CD8 (GEN2) (N=12#) –
BOR and Response over Time Data cut-off Sep 30, 2023 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 patients 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 IMA203 Phase 1b vs IMA203CD8 (GEN2) Trend towards responses at lower cell dose and higher tumor burden with IMA203CD8 Higher peak expansion (Cmax) 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 week 1: for patient A-DL5-05
data not available for week 1 Data cut-off Sep 30, 2023 IMA203CD8 IMA203CD8 (GEN2) IMA203 IMA203CD8 (GEN2) IMA203CD8 (GEN2) IMA203 IMA203CD8 (GEN2) IMA203 IMA203
ACTengine® IMA203CD8 (GEN2)
TCR-T Monotherapy Targeting PRAME Summary of IMA203CD8 Clinical Data and Planned Next Steps Enhanced primary and secondary pharmacology when compared to IMA203 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 Next Step Clinical footprint expansion outside of melanoma in addition to treating melanoma patients Data cut-off Sep 30, 2023 IMA203CD8
PRAME mRNA expression in IMA203
Phase 1a and Phase 1b responders at RP2D (n=13) PRAME mRNA expression in IMA203CD8 (GEN2) responders (n=7) Potential of IMA203 in Additional Solid Cancer Indications Based on PRAME Expression in IMA203 and IMA203CD8 (GEN2) Responders %
PRAME-positive patients1 PRAME target expression distribution (blue histogram) based on TCGA RNAseq data, patient data (black dots) based on IMADetect® qPCR 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 Development Strategy Step 1 IMA203 in cutaneous melanoma (potentially bundled with uveal melanoma) as first tumor type targeted to enter registration-enabling trial
Further dose escalation and signal finding in ovarian cancer and uterine cancer in dedicated dose expansion cohorts 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
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% 947 IMA203 TCR-T Has the Potential to Reach a Large Patient Population ~39,000 Patients per Year in the US only 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 à Incidence) Inclusion of patients with lower PRAME-threshold TOTAL ~39,000 annually in the US IMA203
TCER® – TCR Bispecifics
TCER® – Immatics’
Next-generation, Half-Life Extended Bispecifics Proprietary TCER® Format Consisting of Three Distinct Elements 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 à safely apply high drug doses for activity in a broad range of tumors à achieve
optimized scheduling 2 1 3 Cytotoxic lytic granules Tumor cell killing Activated T cell TCER®
TCER® – Immatics’
Next-generation, Half-Life Extended Bispecifics pHLA targeting TCR High-affinity (single digit nM) TCR targeting XPRESIDENT®-selected tumor-specific peptide-HLA molecules Broad therapeutic window through XPRESIDENT®-guided affinity
maturation (>1000x)1 Complete tumor eradication in mouse xenograft models at low doses T cell recruiting antibody Low-affinity (triple digit nM) T cell recruiter against both TCR & CD3 Optimized biodistribution aiming for
enrichment at tumor site and prevention of CRS2 Superior anti-tumor activity in mouse models as compared to widely used CD3 recruiters Next-generation TCER® format Off-the-shelf biologic with antibody-like
manufacturability3 and low cost of goods Superior anti-tumor activity4 compared to six alternative bispecific formats 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® 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 specificity1 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 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 Mice1 1 Hs695T xenograft model in NOG mice, 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 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 TCER® PRAME peptide presented by HLA-A*02:01 Start of clinical trial in Aug 2023, first clinical data expected 2H 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 2H 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 The current collaboration with Moderna includes the development of mRNA-enabled in vivo expressed TCER® molecules
TCER® IMA401 Targeting
MAGEA4/8 Homogeneous Expression, Broad Prevalence and High Copy Number Target MAGEA4 RNA detection in tumor samples (ISH) Indications Target prevalence [%] 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<0.0012 MAGEA4/8 target is presented at >5-fold higher target density1 than a commonly used MAGEA4 target peptide
TCER® IMA401 (MAGEA4/8)
– Assessment of Anti-Tumor Activity in vitro Patient-Derived Tumor Model NSCLC adenocarcinoma: Male, 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
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 – VL Assay Fc – VL Assay IMA401
Phase 1 Clinical Trial to Evaluate
TCER® IMA401 Targeting MAGEA4/8 MTD: maximum tolerated dose, RP2D: recommended phase 2 dose; BLRM: Bayesian logistic regression model; 1 Pharmacokinetics 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. infusions1 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 therapies2 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 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 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 pHLA – aVL 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 2H 2024 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
In Vivo Expressed TCER®
Molecules Targeting Cancer-specific pHLA Targets Combining Immatics’ Target and TCR Platforms with Moderna’s mRNA Technology Immatics Moderna Delivery of TCER® biologics through mRNA Proprietary cancer targets & TCR Bispecifics
format mRNA-encoded TCER® molecule XPRESIDENT® targets XCEPTOR® TCRs TCER® format TCER®
Immatics’ Proprietary Target
and TCR Discovery Platforms
Our TCR-based Approaches Leverage
the Full Target Space beyond the Cancer Cell Surface Technology
True Cancer Targets & Matching
Right TCRs Goal to Maximize Anti-Tumor Activity and Minimize Safety Risks of TCR-based Immunotherapies 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 200 Prioritized Targets Grouped in 3 Target Classes: Well known and characterized parent protein (20%) e.g. MAGE family cancer testis antigens Unknown or poorly
characterized parent protein (60%) e.g. stroma target COL6A3 exon 6 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 >500 million MS/MS spectra >25,000 experiments >8,500 peptides >2,500 cancer & normal tissues analyzed 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™ – „AI is where the data is®“
Potential for Large Patient
Populations across Multiple Solid Cancers Uterine Carcinoma – 97% Uterine Carcinosarcoma – 100% Sarcoma Subtypes – up to 100% Cut. Melanoma ≥ 95% Uveal Melanoma1 ≥ 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% IMA203 / IMA402 PRAME IMA401 MAGEA4/8 IMA204 COL6A3 Exon 6 ACTengine® and TCER® targets demonstrate high prevalence in multiple solid cancers Target prevalence for selected solid cancer indications are based on TCGA
(for SCLC: in-house) RNAseq data combined with a proprietary 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% Technology
Immatics’ Unique Capability
– Identification of the most Relevant Target Example of MAGEA4/8 Peptide Target 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 p<0.0012 Technology MAGEA4/8 target is presented at >5-fold higher target density1 than a commonly targeted MAGEA4 target peptide XPRESIDENT® quantitative information on target density1 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 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 unique interplay between Immatics’ target and TCR
discovery platforms XPRESIDENT® and XCEPTOR® during TCR discovery1 and TCR maturation2 (empowered by our bioinformatics & AI-platform XCUBE™) 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 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 cells1 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™ 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 Technology
Immatics’ Robust Intellectual
Property Portfolio Protection Strategy of Key Assets in Major Markets and Beyond Technologies Targets TCRs TCER® Therapeutic Uses Cell Therapy TCRs with high affinity and specificity profile Differentiated technologies, platforms and
assays for Target Research, TCR and TCER® development >200 prioritized pHLA targets Half-life extended Bispecifics with proprietary TCER® format Treatment of indications and patient groups Clinical ACTengine® and
TCER® candidates: IMA203, IMA203CD8, IMA402, IMA401 Clinical Candidates ACTengine® manufacturing & off-the-shelf ACTallo® platform
ACTengine® IMA204 –
TCR-T Targeting COL6A3 Exon 6
ACTengine® IMA204
First-in-Class TCR-T Targeting Tumor Stroma Key Features HLA-A*02-presented peptide derived from COL6A3 exon 6 Naturally and specifically presented on tumors at high target density1: 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 avidity2: ~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 PRECLINICAL DATA PATIENT POPULATION3 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 vivo1 by Affinity-enhanced IMA204 TCR CD8-independent TCR leads to tumor eradication in all mice treated 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 data 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
ACTallo® –
Immatics’ Allogeneic Cell Therapy Approach Off-the-shelf cell therapy, no need for personalized manufacturing à reduced logistics and time to application Potential for hundreds of doses from one single donor leukapheresis à 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 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 γδ T cells are abundant in the peripheral blood show intrinsic anti-tumor activity naturally infiltrate solid tumors & correlate with favorable prognosis
are HLA-independent, thus do not cause graft-vs-host disease in allogeneic setting can be expanded to high numbers in a cGMP-compatible manner can be effectively redirected using αβ TCR or CAR constructs In vitro anti-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® Expansion Fold-growth (target-positive tumor
cells)
Corporate Information &
Milestones
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 Houston, Texas ~190 FTEs Cell therapy development & manufacturing Munich, Germany ~70 FTEs Various operating functions Tübingen, Germany ~225 FTEs Target & TCR discovery and TCR Bispecifics
development Corporate
Appendix
IMA203 Phase 1 Patient Population
Flow Chart Total Safety Population N=65* enrolled patients N=1 patient in Phase 1a started lymphodepletion but did not receive IMA203 N=64 patients treated with IMA203 N=27 patients in Phase 1a Dose Escalation (DL1-4) Melanoma Efficacy Population
N=5 melanoma patients at DL4/RP2D N=22 Non-melanoma or non-RP2D patients N=37 patients in Phase 1b Cohort A (DL4/5, RP2D) Melanoma Efficacy Population N=25 melanoma patients N=12 non-melanoma patients Thereof N=8 melanoma patients with at least one
scan reported at last update in Nov 2023 Data reported previously except N=2 additional non-melanoma patients, thereof n=1 with at least one scan since last update in Nov 2023 Data reported previously in Nov 2023 Data reported previously in Nov 2023
Patient products manufactured using previous manufacturing protocol without monocyte depletion Appendix Data cut-off Apr 25, 2024 * One additional patient who received IMA203 TCR-T cells shortly before data cut-off is not included
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