UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
REPORT OF FOREIGN PRIVATE ISSUER
Pursuant to Rule
13a-16
or
15d-16
of the Securities Exchange Act of 1934
August 9, 2022
Commission File Number:
001-39363
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 ☐
Indicate by check mark if the registrant is submitting the Form
6-K
in paper as permitted by Regulation
S-T
Rule 101(b)(1): ☐
Indicate by check mark if the registrant is submitting the Form
6-K
in paper as permitted by Regulation S-T
Rule 101(b)(7): ☐ INFORMATION CONTAINED IN THIS REPORT ON FORM
6-K
On August 9, 2022, Immatics N.V. (the “Company”) issued an interim report for the three and
six-month
periods ended June 30, 2022, which is attached hereto as Exhibit 99.1, and issued a press release announcing the second quarter 2022 financial results for the Company, which is attached hereto as Exhibit 99.2. INCORPORATION BY REFERENCE
This Report on Form
6-K
(other than Exhibit 99.2 hereto), including Exhibit 99.1 hereto, shall be deemed to be incorporated by reference into the registration statements on Form S-8
(333-249408
and 333-265820)
and the registration statements on Form F-3
(Registration Nos. 333-258351
and 333-240260)
of Immatics N.V. and to be a part thereof from the date on which this report is filed, to the extent not superseded by documents or reports subsequently filed or furnished.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
Exhibit Number |
Description | |
99.1 |
||
99.2 |
||
101.INS |
XBRL Taxonomy Extension Instance Document | |
101.SCH |
XBRL Taxonomy Extension Schema Document | |
101.CAL |
XBRL Taxonomy Extension Calculation Linkbase Document | |
101.DEF |
XBRL Taxonomy Extension Definition Linkbase Document | |
101.LAB |
XBRL Taxonomy Extension Label Linkbase Document | |
101.PRE |
XBRL Taxonomy Extension Presentation Linkbase Document | |
1
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
IMMATICS N.V. | ||||||
Date: August 9, 2022 |
by: |
/s/ Harpreet Singh | ||||
Harpreet Singh | ||||||
Chief Executive Officer | ||||||
2
Exhibit 99.1
PRELIMINARY NOTE
The unaudited condensed Consolidated Financial Statements for the three and
six-month
periods ended June 30, 2022, 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 “Management’s 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 management’s 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 severity and duration of the evolving
COVID-19
pandemic and the resulting impact on macro-economic conditions; 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, 2021, filed with the Securities and Exchange Commission on March 23, 2022 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 condensed consolidated financial statements and Management’s 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 U.S. Inc.
1
Unaudited Condensed Consolidated Statement of Financial Position of Immatics N.V.
As of |
||||||||||||
Notes |
June 30, 2022 |
December 31, 2021 |
||||||||||
(Euros in thousands) |
||||||||||||
| Assets |
||||||||||||
| Current assets |
||||||||||||
| Cash and cash equivalents |
||||||||||||
| Other financial assets |
15 | |||||||||||
| Accounts receivable |
||||||||||||
| Other current assets |
5 | |||||||||||
| |
|
|
|
|||||||||
| Total current assets |
||||||||||||
| Non-current assets |
||||||||||||
| Property, plant and equipment |
9 | |||||||||||
| Intangible assets |
9 | |||||||||||
| Right-of-use assets |
9 | |||||||||||
| Other non-current assets |
5 | |||||||||||
| |
|
|
|
|||||||||
| Total non-current assets |
||||||||||||
| |
|
|
|
|||||||||
| Total assets |
||||||||||||
| |
|
|
|
|||||||||
| Liabilities and shareholders’ equity |
||||||||||||
| Current liabilities |
||||||||||||
| Provisions |
10 | |||||||||||
| Accounts payable |
||||||||||||
| Deferred revenue |
6 | |||||||||||
| Other financial liabilities |
15 | |||||||||||
| Lease liabilities |
||||||||||||
| Other current liabilities |
11 | |||||||||||
| |
|
|
|
|||||||||
| Total current liabilities |
||||||||||||
| Non-current liabilities |
||||||||||||
| Deferred revenue |
6 | |||||||||||
| Lease liabilities |
||||||||||||
| Other non-current liabilities |
||||||||||||
| |
|
|
|
|||||||||
| Total non-current liabilities |
||||||||||||
| Shareholders’ equity |
||||||||||||
| Share capital |
||||||||||||
| Share premium |
14 |
|||||||||||
| Accumulated deficit |
14 |
( |
) | ( |
) | |||||||
| Other reserves |
( |
) | ( |
) | ||||||||
| |
|
|
|
|||||||||
| Total shareholders’ equity |
||||||||||||
| |
|
|
|
|||||||||
| Total liabilities and shareholders’ equity |
||||||||||||
| |
|
|
|
|||||||||
The accompanying notes are an integral part of these condensed consolidated financial statements.
2
Unaudited Condensed Consolidated Statement of Profit/(Loss) of Immatics N.V.
Three months ended June 30, |
Six months ended June 30, |
|||||||||||||||||||
Notes |
2022 |
2021 |
2022 |
2021 |
||||||||||||||||
(Euros in thousands, except share and per share data) |
(Euros in thousands, except share and per share data) |
|||||||||||||||||||
Revenue from collaboration agreements |
6 | |||||||||||||||||||
Research and development expenses |
( |
) | ( |
) | ( |
) | ( |
) | ||||||||||||
General and administrative expenses |
( |
) | ( |
) | ( |
) | ( |
) | ||||||||||||
Other income |
||||||||||||||||||||
Operating result |
( |
) |
( |
) |
( |
) | ||||||||||||||
Financial income |
7 | |||||||||||||||||||
Financial expenses |
7 | ( |
) | ( |
) | ( |
) | ( |
) | |||||||||||
Change in fair value of warrant liabilities |
7 | ( |
) | ( |
) | ( |
) | |||||||||||||
Financial result |
( |
) |
( |
) | ||||||||||||||||
Profit/(loss) before taxes |
( |
) |
( |
) |
( |
) | ||||||||||||||
Taxes on income |
8 | ( |
) | ( |
) | |||||||||||||||
Net profit/(loss) |
( |
) |
( |
) |
( |
) | ||||||||||||||
Net profit/(loss) per share: |
||||||||||||||||||||
Basic |
( |
) | ( |
) | ( |
) | ||||||||||||||
Diluted |
( |
) |
( |
) |
( |
) | ||||||||||||||
Weighted average shares outstanding: |
||||||||||||||||||||
Basic |
||||||||||||||||||||
Diluted |
||||||||||||||||||||
The accompanying notes are an integral part of these condensed consolidated financial statements.
3
Unaudited Condensed Consolidated Statement of Comprehensive Income/(Loss) of Immatics N.V.
Three months ended June 30, |
Six months ended June 30, |
|||||||||||||||||||
Notes |
2022 |
2021 |
2022 |
2021 |
||||||||||||||||
(Euros in thousands) |
(Euros in thousands) |
|||||||||||||||||||
| Net profit/(loss) |
( |
) |
( |
) |
( |
) | ||||||||||||||
| Other comprehensive income/(loss) |
||||||||||||||||||||
| Items that may be reclassified subsequently to profit or loss, net of tax |
||||||||||||||||||||
| Currency translation differences from foreign operations |
( |
) | ||||||||||||||||||
| |
|
|
|
|
|
|
|
|||||||||||||
| Total comprehensive income/(loss) for the period |
( |
) |
( |
) |
( |
) | ||||||||||||||
| |
|
|
|
|
|
|
|
|||||||||||||
The accompanying notes are an integral part of these condensed consolidated financial statements.
4
Unaudited Condensed Consolidated Statement of Cash Flows of Immatics N.V.
Six months ended June 30, |
||||||||
2022 |
2021 |
|||||||
(Euros in thousands) |
||||||||
| Cash flows from operating activities |
||||||||
| Net profit/(loss) |
( |
) | ||||||
| Adjustments for: |
||||||||
| Interest income |
( |
) | ( |
) | ||||
| Depreciation and amortization |
||||||||
| Interest expense |
||||||||
| Equity settled share-based payment |
||||||||
| Net foreign exchange differences |
||||||||
| Change in fair value of warrant liabilities |
( |
) | ||||||
| Changes in: |
||||||||
| (Increase)/decrease in accounts receivable |
( |
) | ||||||
| (Increase)/decrease in other assets |
( |
) | ||||||
| Increase/(decrease) in accounts payable and other liabilities |
( |
) | ||||||
| Interest received |
||||||||
| Interest paid |
( |
) | ( |
) | ||||
| |
|
|
|
|||||
| Net cash provided by/(used in) operating activities |
( |
) | ||||||
| |
|
|
|
|||||
| Cash flows from investing activities |
||||||||
| Payments for property, plant and equipment |
( |
) | ( |
) | ||||
| Cash paid for investments classified in Other financial assets |
( |
) | ( |
) | ||||
| Cash received from maturity of investments classified in Other financial assets |
||||||||
| Payments for intangible assets |
( |
) | ( |
) | ||||
| Proceeds from disposal of property, plant and equipment |
||||||||
| |
|
|
|
|||||
| Net cash (used in)/provided by investing activities |
( |
) |
( |
) | ||||
| |
|
|
|
|||||
| Cash flows from financing activities |
||||||||
| Proceeds from issuance of shares to equity holders |
— | |||||||
| Transaction costs deducted from equity |
( |
) | — | |||||
| Payments for leases |
( |
) | ( |
) | ||||
| |
|
|
|
|||||
| Net cash provided by/(used in) financing activities |
( |
) | ||||||
| |
|
|
|
|||||
| Net increase/(decrease) in cash and cash equivalents |
( |
) | ||||||
| |
|
|
|
|||||
| Cash and cash equivalents at beginning of period |
||||||||
| |
|
|
|
|||||
| Effects of exchange rate changes on cash and cash equivalents |
||||||||
| |
|
|
|
|||||
| Cash and cash equivalents at end of period |
||||||||
| |
|
|
|
|||||
The accompanying notes are an integral part of these condensed consolidated financial statements.
5
Unaudited Condensed Consolidated Statement of Changes in Shareholders’ equity of Immatics N.V.
(Euros in thousands) |
Notes |
Share capital |
Share premium |
Accumulated deficit |
Other reserves |
Total share- holders’ equity |
||||||||||||||||||
Balance as of January 1, 2021 |
( |
) |
( |
) |
||||||||||||||||||||
Other comprehensive income |
— | — | — | |||||||||||||||||||||
Net loss |
— | — | ( |
) | — | ( |
) | |||||||||||||||||
Comprehensive income/(loss) for the year |
— |
— |
( |
) |
( |
) | ||||||||||||||||||
Equity-settled share-based compensation |
12 | — | — | — | ||||||||||||||||||||
Balance as of June 30, 2021 |
( |
) |
( |
) |
||||||||||||||||||||
Balance as of January 1, 2022 |
( |
) |
( |
) |
||||||||||||||||||||
Other comprehensive income |
— | — | — | |||||||||||||||||||||
Net profit |
— | — | — | |||||||||||||||||||||
Comprehensive income for the year |
— |
— |
||||||||||||||||||||||
Equity-settled share-based compensation |
12 | — | — | — | ||||||||||||||||||||
Share options exercised |
— | — | — | |||||||||||||||||||||
Issue of share capital – net of transaction costs |
14 | — | — | |||||||||||||||||||||
Balance as of June 30, 2022 |
( |
) |
( |
) |
||||||||||||||||||||
The accompanying notes are an integral part of these condensed consolidated financial statements.
6
Notes to the Unaudited 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 and Immatics US Inc. became 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.
These interim condensed consolidated financial statements of the Group for the three and six months ended June 30, 2022 August 9, 2022 .
2. Significant events and changes in the current reporting period
The following significant events or transactions occurred during the three and six months ended June 30, 2022.
License, Development and Commercialization agreement with BMS
On December 10, 2021, Immatics Biotechnologies GmbH entered into a License, Development and Commercialization agreement (the “BMS agreement”) with Bristol-Myer-Squibb Company (“BMS”). The BMS agreement became effective on January 26, 2022, after the expiration of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976 on January 25, 2022. Pursuant to the BMS agreement, the Group received a €133 million ($150 million) upfront cash payment related to the performance obligations under the contract. The Group identified the transfer of a global exclusive IMA401 license including technology transfer and the contractually agreed clinical trial services including participation in Joint Steering Committee meetings as distinct performance obligations. The Group is eligible to receive up to $770 million development, regulatory and commercial milestone payments, in addition to low double-digit royalty payments on net sales of IMA401. Immatics retains the options to
co-fund
U.S. development in exchange for enhanced U.S. royalty payments and/or to
co-promote
IMA401 in the US. In November 2021, Immatics filed a Clinical Trial Application (CTA) with Paul-Ehrlich-Institute (PEI), the German federal regulatory authority, for the development of IMA401. The clinical trial, which commenced in the second quarter of 2022, will enroll patients across various solid tumor types.
Under IFRS 15, the Group applied significant judgement when evaluating whether the obligations under the BMS agreement represent one performance obligation, combined performance obligations or multiple performance obligations, the allocation of the transaction price to identified performance obligations, and the determination of whether milestone payments should be included in the transaction price.
The Group concluded that BMS is a customer since the BMS agreement does contain elements of a customer relationship even though it is a collaboration agreement, where to some degree both risks and benefits are shared between the Group and BMS. The BMS agreement clearly states deliverables to be delivered by the Group and BMS as mentioned below and creates enforceable rights and obligations.
The Group transferred license rights and is performing clinical trial services. While the clinical trial is a prerequisite for approval of the product, it does not modify the underlying product. The manufacturing of the product for the trial is already completed. The clinical trial will evaluate safety, tolerability, and initial anti-tumor activity of IMA401 in patients with recurrent and/or refractory solid tumors, but there is no modification planned as part of this. With the end of the
pre-clinical
phase, there was no further enhancement of the products planned. We therefore concluded that BMS can benefit from each performance obligation on its own and they are separately identifiable from other promises in the BMS agreement. The Group concluded that there were two distinct performance obligations under the BMS agreement, the granted license and the conduct of clinical trial services.
At inception of the BMS agreement, the Group determined the transaction price. We evaluated inclusion of the milestones as part of the transaction price under the most-likely method. Milestone payments are included at the most likely amount in the transaction price. However, variable consideration is only included in the transaction price to the extent that it is highly probable that a significant reversal in the amount of cumulative revenue recognized will not occur. The contractual agreed milestone payments with BMS relate to the license. It is not highly probable that the Group will receive any of these milestone payments. Based on that the Group concludes that no variable consideration is considered as transaction price at contract inception. At the end of each reporting period, the Group
re-evaluates
the probability of achievement of milestones and, if necessary, adjusts its estimate of the overall transaction price. Sales-based royalties will only be recognized as sales occur since the license is the predominant item to which the royalty relates.
7
The Group is required to allocate the determined transaction price of €133 million ($150 million) to the two separate identified performance obligations of the BMS agreement, based on the standalone selling price of each performance obligation as the upfront payment of €133 million ($150 million) covers the cost of clinical trial services as well as an initial payment for the license.
Since the BMS agreement consist of two performance obligations, the Group determined the underlying stand-alone selling price for each performance obligation, to allocate the transaction price to the performance obligations. The estimation of the stand-alone selling price included estimates regarding forecasted cost for future services, profit margins and development timelines.
The most reasonable estimation method for the performance obligation related to clinical trial services is the expected cost method, due to the fact that the Group is able to use expected costs including a profit margin to estimate the stand-alone selling price. On top of the forecast of expected costs, the Group added an appropriate profit margin based on average company profit margins for clinical trial services.
To estimate a stand-alone selling price for the performance obligation related to the IMA401 license, the Group 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. The Group concluded following transaction price allocation of the €133 million ($150 million) upfront payment as of March 31, 2022:
1. |
Stand-alone selling price for clinical trial services: € |
2. |
Stand-alone selling price for the license grant: € |
The Group evaluated each performance obligation to determine if it can be satisfied at a point in time or over time. The control over the granted license is transferred at a point in time, after BMS obtains the rights to use the license at the effective date of the agreement. The performance obligation related to promised clinical trial services is satisfied over time. The Group transfers control of these agreed services over time and will therefore recognize revenue over time as costs are incurred using a
cost-to-cost
method.
At inception of the BMS agreement, €42 million were initially deferred on the Groups Consolidated Statement of Financial Position. For the three months ended June 30, 2022, €2.8 million revenue is recognized based on the cost-to-cost method. For the six months ended June 30, 2022, €4.3 million revenue is recognized based on the cost-to-cost method and €91 million revenue is recognized related to the license for IMA 401.
License
, Development and Commercialization agreement with Bristol-Myers-Squibb to develop Gamma Delta Allogeneic Cell Therapy program
On June 1, 2022, Immatics US, Inc. entered into a License, Development and Commercialization agreement (the “Allogeneic ACT agreement”) with Bristol-Myer-Squibb Company (“BMS”). Pursuant to the Allogeneic ACT agreement, the Group received a €57.7 million ($60 million) upfront cash payment plus an additional payment of €4.8 million ($5 million) related to the performance obligations under the contract. The Group identified the transfer of an exclusive right and license with the right to grant sublicenses under the Immatics Licensed IP, technology transfer, contractually agreed research and development services including participation in Joint Steering Committee meetings and the delivery of research progress reports to BMS as a combined performance obligation. The Group is eligible to receive up to $700 million development, regulatory and commercial milestone payments, in addition to tiered royalty payments of up to low double-digit percentages on net product sales.
Under IFRS 15, the Group applied significant judgement when evaluating whether the obligations under the Allogeneic ACT agreement represent one combined performance obligation or multiple performance obligations and the determination of whether milestone payments should be included in the transaction price.
The Group concluded that BMS is a customer since BMS obtains through the Allogeneic ACT agreement the output of Immatics’ ordinary activities in exchange for a consideration. The Allogeneic ACT agreement clearly states the deliverables to the Group and BMS as mentioned below and creates enforceable rights and obligations.
The Group granted to BMS exclusive access to licensed products and is performing research and development services. The research and development services performed by the Group will cover preclinical development of the initial two Bristol Myers Squibb-owned programs and are not distinct from the licensed IP, since the preclinical platform does not have a standalone value without further development. Based on the facts and circumstances, the collaboration agreement contains multiple promises, which aggregate to one combined performance obligation.
At inception of the Allogeneic ACT agreement, the Group determined the transaction price. The Group evaluated inclusion of the milestones as well as potential cost reimbursements as part of the transaction price under the most-likely method. Milestone payments are included at the most likely amount in the transaction price. However, variable consideration is only included in the transaction price to
8
the extent that it is highly probable that a significant reversal in the amount of cumulative revenue recognized will not occur. For the contractual agreed milestone payments with BMS, the license is predominant. Based on that the Group concludes that no variable consideration is considered as transaction price at contract inception. At the end of each reporting period, the Group
re-evaluates
the probability of achievement of milestones and, if necessary, adjusts its estimate of the overall transaction price. Sales-based royalties will only be recognized as sales occur since the license is the predominant item to which the royalty relates.
The Group allocated the determined total transaction price consisting of the received payments as well as
cost
reimbursements to the single combined performance obligation of the Allogeneic ACT agreement. Based
on the facts mentioned above the Group determined that the combined performance obligation related to promised research and development services is satisfied over time and therefore revenue will be recognized over time as costs for the research and development services incurred using a cost-to-cost method.
At inception of the Allogeneic ACT agreement, €60.7 million were initially deferred on the Groups Consolidated Statement of Financial Position. For the three months ended June 30, 2022, €0.6 million revenue is recognized based on the cost-to-cost method.
Amendment to Strategic Collaboration Agreement with Bristol-Myers-Squibb on novel adoptive cell therapies
On June 1, 2022, Immatics Biotechnologies GmbH entered into an Amendment to the Strategic Collaboration Agreement
originally signed in 2019
(the “amendment”) with Bristol-Myer-Squibb Company (“BMS”). Pursuant to the amendment, the Group received a €18.7 million ($20 million) upfront cash payment related to the performance obligations under the contract. Under the amendment, Immatics will
undertake
an additional T Cell Receptor Engineered T cell Therapy (TCR-T) program against a
solid tumor target discovered with Immatics’ XPRESIDENT technology. The program will utilize proprietary T Cell Receptors (TCRs) identified by Immatics’ XCEPTOR TCR discovery and engineering platform.
The increased consideration reflects
the stand-alone selling price at contract inception and the amendment contains performance obligations that are distinct from the original performance obligation under the contract. Therefore, the Group determined to account for the modification of the Allogeneic ACT agreement signed in 2019, triggered by the amendment as a separate contract.
Immatics will be responsible for the development and validation of these programs through lead candidate stage, at which time BMS may exercise
opt-in
rights and assume sole responsibility for further worldwide development, manufacturing and commercialization of the TCR-T
cell therapies. Immatics would have certain early-stage co-development
rights or co-funding
rights for selected TCR-T
cell therapies arising from the collaboration. With respect to this amendment, Immatics may be eligible to receive regulatory and sales milestones as well as royalties in line with the BMS collaboration agreement signed in 2019.The Group identified the transfer of an exclusive right and license to patents on one additional target and respective therapeutic treatments, including technology transfer, the contractually agreed research and development services by the Group and the participation in Joint Steering Committee meetings as combined performance
obligation as they are not distinct from each other.
At inception of the amendment, the Group determined the transaction price. The Group evaluated inclusion of the milestones as part of the transaction price under the most-likely method. Milestone payments are included at the most likely amount in the transaction price. However, variable consideration is only included in the transaction price to the extent that it is highly probable that a significant reversal in the amount of cumulative revenue recognized will not occur. The contractual agreed milestone payments with BMS relate to the license. Based on that the Group concludes that no variable consideration is considered as transaction price at contract inception. At the end of each reporting period, the Group re-evaluates the probability of achievement of milestones and, if necessary, adjusts its estimate of the overall transaction price. Sales-based royalties will only be recognized as sales occur since the license is the predominant item to which the royalty relates.
The Group concluded to allocate the determined transaction price of €18.7 million ($20 million) to the performance obligation from the amendment - the research and development services and the license for the targets. The Group determined that the performance obligation is satisfied over time and therefore revenue will be recognized over time as costs incurred using a cost-to-cost method.
9
At inception of the agreement, €18.7 million were initially deferred on the Groups Consolidated Statement of Financial Position. For the three months ended June 30, 2022, no revenue is recognized based on the cost-to-cost method, due to the fact that no research and development work was
performed.
Research collaboration and License agreement with Editas Medicine, Inc.
On May 27, 2022, Immatics US, Inc. entered into a Research collaboration and License agreement (the “Editas agreement”) with Editas Medicine, Inc. (“Editas”). The Editas agreement became effective on May 27, 2022. Pursuant to the Editas agreement, the Group paid upfront a
one-time
and non-refundable
fee related to the Groups access to a non-exclusive
right to Editas Medicine’s CRISPR technology and intellectual property as well as for services provided by Editas. The Group will together with Editas combine gamma-delta T cell adoptive cell therapies and gene editing to develop medicines for the treatment of cancer. The Group determined to account for the upfront payment as prepaid research and development expenses. The prepaid expense will be consumed over the term of the research and development activities.
COVID-19
In December 2019, a novel strain of coronavirus (“COVID-19”) emerged. In response, many countries and businesses still institute travel restrictions, quarantines, and office closures. The extent of the pandemic and governmental responses may impact our ability to obtain raw materials and equipment used for research and development, obtain sufficient additional funds to finance our operations, and conduct clinical trials, any of which could materially and adversely affect our business.
Management enacted significant measures to protect the Group’s supply chain, employees, and the execution of clinical trials and continues to monitor the situation. To date, the pandemic has not significantly impacted the Group. The ongoing spread of COVID-19 may in the future negatively impact the Group’s ability to conduct clinical trials, including potential delays and restrictions on the Group’s ability to recruit and retain patients, and the availability of principal investigators and healthcare employees. COVID-19 could also affect the operations of contract research organizations, which may also result in delays or disruptions in the supply of product candidates. Given the current situation we do not expect significant negative impacts on the Group’s activities in the future, but variants of COVID-19 could limit the impact of vaccines and lead to negative impacts on the Group’s activities.
3. Significant accounting policies
Basis of presentation
The interim condensed consolidated financial statements of the Group as of June 30, 2022 and for the three and six months ended June 30, 2022 and 2021 have been prepared in accordance with International Accounting Standard 34 (“Interim Financial Reporting”), as issued by the International Accounting Standards Board (“IASB”).
The 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 Group’s annual financial statements for the year ended December 31, 2021, which have been prepared in accordance with International Financial Reporting Standards (“IFRS”) as issued by the IASB, taking into account the recommendations of the International Financial Reporting Standards Interpretations Committee (“IFRS IC”).
The interim condensed consolidated financial statements are presented in Euros. Amounts are stated in thousands of Euros, unless otherwise indicated.
The accounting policies adopted in the preparation of the interim condensed consolidated financial statements are consistent with those followed in the preparation of the Group’s annual consolidated financial statements for the year ended December 31, 2021. The new and amended standards and interpretations
applicable
for the first time as of January 1, 2022, as disclosed in the notes to the consolidated financial statements for the year ended December 31, 2021, had no impact on the interim condensed consolidated financial statements of the Group for the three and six months ended June 30, 2022.
The Group reported basic and diluted earnings per share. 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 for the six months ended June 30, 2022, 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 Group’s equity awards and Immatics Warrants for which the exercise price is exceeding the Groups weighted average share price for the six months ended June 30, 2022, are anti-dilutive instruments and are excluded in the calculation of diluted weighted average number of ordinary shares. The Group was loss-making during the three months ended June 30, 2022 as well as during the three and six months ended June 30, 2021, therefore all instruments are anti-dilutive instruments and are excluded in the calculation of diluted weighted average number of ordinary shares outstanding, including the outstanding equity awards and the 7,187,500
2022.
10
The
Group determined its revenue recognition policies related to the new collaboration agreements signed during the
six
months ended June 30, 2022. Refer to section within the Note 2 for further details regarding the accounting treatment and significant estimates by the Group applied in connection with the determination of the accounting treatment of the collaboration agreements.4. Segment information
The Group manages its operations as a single segment for the purposes of assessing performance and making operating decisions. The Group’s 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 Group’s resources.
5. Other current and
non-current
assets As of |
||||||||
June 30, 2022 |
December 31, 2021 |
|||||||
(Euros in thousands) |
||||||||
| Prepaid expenses |
||||||||
| Value added tax receivable |
||||||||
| Grant receivable |
||||||||
| Other assets |
||||||||
| |
|
|
|
|||||
| Other current assets |
||||||||
| |
|
|
|
|||||
The Group recognizes receivables for government grants, when it is reasonably assured that the grant will be received, and all contractual conditions have been complied with. As of June 30, 2022, and December 31, 2021, no receivables were considered impaired.
Prepaid expenses include expenses for licenses and software of €4.5 million as of June 30, 2022 and €0.5 million as of December 31, 2021 and prepaid insurance expenses of €0.2 million as of June 30, 2022 and €1.3 million as of December 31, 2021. The Group accrued €0.5 million as of June 30, 2022 and €0.7 million as of December 31, 2021 of incremental cost for the successful arrangement of the BMS collaboration signed in 2019 and the Genmab collaboration agreement.
Additionally, prepaid expenses include expenses for maintenance of €0.5 million as of June 30, 2022 and €0.8 million as of December 31, 2021. The remaining amount is mainly related to CRO expenses and prepaid rent.
Other assets include receivables from capital gains tax of €0.3 million as of June 30, 2022 and €0.3 million as of December 31, 2021. Furthermore, other assets include receivables from lease incentive of €1.1 million as of June 30, 2022. The remaining amount is mainly related to prepaid deposit expenses.
As of |
||||||||
June 30, 2022 |
December 31, 2021 |
|||||||
(Euros in thousands) |
||||||||
| Prepaid expenses |
||||||||
| |
|
|
|
|||||
| Other non-current assets |
||||||||
| |
|
|
|
|||||
Other non-current assets include the non-current portion of prepayments for licensing agreements of €4.2 million, prepaid maintenance expenses of €0.3 million and accrued incremental cost of the BMS and Genmab collaboration agreement of €0.2 million as of June 30,
2022.
11
6. Revenue from collaboration agreements
The Group earns revenue through strategic collaboration agreements with third party pharmaceutical and biotechnology companies. As of June 30, 2022, the Group had five strategic collaboration agreements in place. During the six months ended June 30, 2022, the Group entered into new collaboration agreements with BMS. Refer to Note 2 “License, Development and Commercialization agreement with BMS”, “License, Development and Commercialization agreement with Bristol-Myers-Squibb to develop Gamma Delta Allogeneic Cell Therapy program” and “Amendment to Strategic Collaboration Agreement with Bristol-Myers-Squibb on novel adoptive cell therapies” for further details. Four of the five collaboration agreements are still at
pre-clinical
stage and the BMS IMA401 collaboration agreement is at clinical stage. As the Amgen collaboration agreement was terminated in October 2021, the Group did not recognize any revenue for this collaboration for the three and six months ended June 30, 2022. The
Group earned revenue from collaboration agreements from the following collaborators during the three and six months ended June 30, 2022 and 2021:
Three months ended June 30, |
Six months ended June 30, |
|||||||||||||||
2022 |
2021 |
2022 |
2021 |
|||||||||||||
(Euros in thousands) |
(Euros in thousands) |
|||||||||||||||
| Amgen |
||||||||||||||||
| Genmab |
||||||||||||||||
| BMS |
||||||||||||||||
| GSK |
||||||||||||||||
| |
|
|
|
|
|
|
|
|||||||||
| Total |
||||||||||||||||
| |
|
|
|
|
|
|
|
|||||||||
The revenue from collaboration agreements with BMS includes the revenue regarding the right-to-use license for IMA401 amounting to €91.3 million for the six months ended June 30, 2022. The Group recognized €19.2 million revenue based on the cost-to-cost method regarding the four collaboration agreements with BMS for the six months ended June 30, 2022.
As of June 30, 2022, 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 June 30, 2022, Immatics had no t received any milestone or royalty payments in connection with the collaboration agreements.
The Group expects to recognize the remaining deferred revenue balance into revenue as it performs the related performance obligations under each contract. Deferred revenue related to the collaboration agreements consists of the following as of June 30, 2022 and December 31, 2021:
As of |
||||||||
June 30, 2022 |
December 31, 2021 |
|||||||
(Euros in thousands) |
||||||||
| Current |
||||||||
| Non-current |
||||||||
| |
|
|
|
|||||
| Total |
||||||||
| |
|
|
|
|||||
The Group recognized expenses related to the amortization of capitalized cost of obtaining a contract of €0.2 million and €0.1 million for the three months ended June 30, 2022 and June 30, 2021.
The Group recognized expenses related to the amortization of capitalized cost of obtaining a contract of €0.3 million and €0.1 million for the six months ended June 30, 2022 and June 30, 2021.
1
2
7. Financial result
Financial income and financial expenses consist of the following:
Three months ended June 30, |
Six months ended June 30, |
|||||||||||||||
2022 |
2021 |
2022 |
2021 |
|||||||||||||
(Euros in thousands) |
(Euros in thousands) |
|||||||||||||||
| Interest income |
||||||||||||||||
| Foreign currency gains |
||||||||||||||||
| Gain on other financial instruments |
||||||||||||||||
| |
|
|
|
|
|
|
|
|||||||||
| Financial income |
||||||||||||||||
| |
|
|
|
|
|
|
|
|||||||||
| Interest expenses |
( |
) | ( |
) | ( |
) | ( |
) | ||||||||
| Foreign currency losses |
( |
) | ( |
) | ( |
) | ( |
) | ||||||||
| Losses on other financial instruments |
( |
) | ||||||||||||||
| |
|
|
|
|
|
|
|
|||||||||
| Financial expenses |
( |
) |
( |
) |
( |
) |
( |
) | ||||||||
| Change in fair value of warrant liabilities |
( |
) | ( |
) | ( |
) | ||||||||||
| |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Financial result |
( |
) |
( |
) | ||||||||||||
| |
|
|
|
|
|
|
|
|||||||||
Foreign currency gains and losses mainly consist of unrealized gains and losses in connection with our USD holdings of both cash and cash equivalents as well as bonds.
The fair value of the warrants decreased from €3.88 per warrant as of December 31, 2021 to €1.58 as of March 31, 2022 and increased to €1.96 as of June 30, 2022. The result is an increase in fair value of warrant liabilities of €2.8 million for the three months ended June 30, 2022 and a decrease in fair value of warrant liabilities of €13.7 million for the six months ended June 30, 2022.
Losses on other financial instruments consist of losses from unrealized currency forward contracts.
8. Income Tax
During the three months ended March 31, 2022, the Group generated a net income due to the recognition of revenue in connection with the license component of the BMS agreement. This one-time revenue is not accounted for under German GAAP and consequently under German tax accounting. Instead, the Group recognizes revenue for the BMS agreement over the 28.5
period
of the clinical trial service. The deferred tax liability arising from the temporary difference related to delayed revenue recognition under German tax accounting is offset by deferred tax assets on tax losses carried forward that were previously not capitalized due to the Groups expectation of generating taxable losses in the foreseeable future. During the three and six months ended June 30, 2022 and 2021, the Group’s German operations were subject to a statutory tax rate of %.
For Immatics Biotechnologies GmbH, the Group recognized an income tax expense and an equivalent current tax liability in the amount of €1.2 million for the three months ended June 30, 2022. The income tax expense is calculated based on taxable income of Immatics Biotechnologies GmbH for the 60 % of an income of a given year can be offset with tax losses carried forward. Accordingly, 40 % of the income before tax of Immatics Biotechnologies GmbH are subject to income tax.
six
months ended June 30, 2022. The Group applied the estimated effective tax rate of the financial year 2022 to the taxable income for the six
months ended June 30, 2022. Since no deferred tax assets have been recognized as of December 31, 2021, 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 June 30, 2022. In accordance with §10d para 2 EStG (G
erman income tax code), As the profit 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 Group’s taxable income in future years, which could result in the recognition of deferred tax assets.
The Group continued to generate losses for all other entities within the Group during the three and six months ended June 30, 2022 as well as for all entities during the three and six months ended June 30, 2021.
Due to the ARYA Merger described in Note 3 of the Group’s annual financial statements for the year ended December 31, 2020, 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.
1
3
9. Intangible assets, Property, plant and equipment and Right-of-use assets
During the three months ended June 30, 2022 and June 30, 2021, the Group acquired property, plant and equipment and intangible assets in the amount of €1.1 million and €1.8 million, respectively.
During the six months ended June 30, 2022 and June 30, 2021, the Group acquired property, plant and equipment and intangible assets in the amount of €2.2 million and €2.4 million, respectively.
During the six months ended June 30, 2022, extensions to existing lease agreements as well as the lease of a new facility in Houston resulted in an addition in right-of-use assets and corresponding lease liability in the amount of €6.7 million.
The
Group used an incremental borrowing rate (“IBR”) for each respective lease to calculate the initial lease liability.
10. Provisions
Provisions consisted of the following as of June 30, 2022 and December 31, 2021:
As of |
||||||||
June 30, 2022 |
December 31, 2021 |
|||||||
(Euros in thousands) |
||||||||
| Other provision |
||||||||
| Provision for bonuses |
||||||||
| |
|
|
|
|||||
| Total provisions |
||||||||
| |
|
|
|
|||||
These amounts include provisions for the Group’s annual employee bonuses. These amounts are classified as a provision as of June 30, 2022, because the amount to be paid is uncertain.
11. Other current liabilities
Other current liabilities consisted of the following as of June 30, 2022 and December 31, 2021.
As of |
||||||||
June 30, 2022 |
December 31, 2021 |
|||||||
(Euros in thousands) |
||||||||
| Income tax liability |
||||||||
| Payroll tax |
||||||||
| Accrual for vacation |
||||||||
| Other |
||||||||
| |
|
|
|
|||||
| Total |
||||||||
| |
|
|
|
|||||
Other current liabilities are non-interest-bearing and are due within one year . The carrying amounts of other current liabilities represents fair value due to their short-term nature.
12. 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´ s shareholders approved the Company’s 2022 stock option and incentive plan (“2022 Equity Plan”). The 2022 Equity Plan allows the company to grant additional options, other than that, it does not materially differ from the 2020 Equity Plan.
Immatics Biotechnologies GmbH previously issued share-based awards to employees under two different plans. Under the Immatics Biotechnologies 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 Biotechnologies 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 Group’s discretion, as equity
settled.
14
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 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
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 fully on
July 31, 2021
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 ten-year contract life.
Matching Stock Options outstanding as of June 30, 2022:
2022 |
||||||||
Weighted average exercise price |
Number |
|||||||
| Matching Stock Options outstanding on January 1, |
||||||||
| Matching Stock Options forfeited |
||||||||
| Matching Stock Options exercised |
||||||||
| Matching Stock Options expired |
||||||||
| Matching Stock Options outstanding on June 30, |
||||||||
| Matching Stock Options exercisable on June 30, |
||||||||
| Weighted average remaining contract life (years) |
||||||||
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 to 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).
Based on the terms of the Converted Options award agreements, the awards had a service commencement date in June 2020. However, the grant date criteria for these awards, as specified in IFRS 2 and the underlying award agreements, were not met until July 1, 2020.
Converted Options outstanding as of June 30, 2022:
2022 |
||||||||
Weighted average exercise price in |
Number |
|||||||
| Converted Options outstanding on January 1, |
||||||||
| Converted Options forfeited |
||||||||
| Converted Options exercised |
||||||||
| Converted Options expired |
||||||||
| Converted Options outstanding on June 30, |
||||||||
| Converted Options exercisable on June 30, |
||||||||
| Weighted average remaining contract life (years) |
||||||||
Under the 2020 Plan and the 2022 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 solely on a four-year time-based vesting schedule. Under the 2022 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.
1
5
The Company granted Service Options on March 22, 2022, on March 29, 2022, on June 14, 2022, and on June 30, 2022, 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 $5.84
As of March 22, 2022 |
As of March 29, 2022 |
As of June 14, 2022 |
As of June 30, 2022 |
|||||||||||||
| Exercise price in USD |
$ | $ | $ | $ | ||||||||||||
| Underlying share price in USD |
$ | $ | $ | $ | ||||||||||||
| Volatility |
% | % | % | % | ||||||||||||
| Time period (years) |
||||||||||||||||
| Risk free rate |
% | % | % | % | ||||||||||||
| Dividend yield |
% | % | % | % | ||||||||||||
Service Options outstanding as of June 30, 2022:
2022 |
||||||||
Weighted average exercise price in USD |
Number |
|||||||
| Service Options outstanding on January 1, |
||||||||
| Service Options granted in March, |
||||||||
| Service Options granted in June, |
||||||||
| Service Options forfeited |
||||||||
| Service Options exercised |
||||||||
| Service Options expired |
||||||||
| Service Options outstanding on June 30, |
||||||||
| Service Options exercisable on June 30, |
||||||||
| Weighted average remaining contract life (years) |
||||||||
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.
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 described above in the calculation of the award’s 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:
PSUs outstanding as of June 30, 2022:
2022 |
||||||||
Weighted average exercise price in USD |
Number |
|||||||
| PSUs outstanding on January 1, |
||||||||
| PSUs granted |
||||||||
| PSUs forfeited |
||||||||
| PSUs outstanding on June 30, |
||||||||
| PSUs exercisable on June 30, |
||||||||
| Weighted average remaining contract life (years) |
||||||||
1
6
The Group recognized total employee-related share-based compensation expense, during the three and six months ended June 30, 2022 and 2021 as set out below:
Three months ended June 30, |
Six months ended June 30, |
|||||||||||||||
2022 |
2021 |
2022 |
2021 |
|||||||||||||
(Euros in thousands) |
(Euros in thousands) |
|||||||||||||||
| Research and development expenses |
||||||||||||||||
| General and administrative expenses |
||||||||||||||||
| |
|
|
|
|
|
|
|
|||||||||
| Total share-based compensation |
||||||||||||||||
| |
|
|
|
|
|
|
|
|||||||||
The share-based compensation expense for the three and six months ended June 30, 2022 decreased, since the matching stock options issued under 2020 Equity Plan vested fully on July 31, 2021.
13. Related party disclosures
During the three and six months ended June 30, 2022 the Group did not enter into any new related-party transactions with its key management personnel or with related
entities other than the granting of a total of 340,000 Service options to its key management personnel and Board of Directors for the six months ended June 30, 2022.
14. Shareholders’ equity
During the three months ended June 30, 2022, the
Group issued 2.4 million shares under the ATM agreement with SVB Securities LLC and collected a
gross amount of €17.1 million less transaction costs of €0.5 million, resulting in a24 thousand and share premium of
€16.6 million.
gross amount of €
n
increase in share capital of €€
15. Financial Instruments
Set out below are the carrying amounts and fair values of the Group’s financial instruments that are carried in the interim condensed consolidated financial statements.
Euros in thousands |
Carrying amount |
Fair value |
||||||||||||||||
IFRS 9 |
June 30, 2022 |
December 31, 2021 |
June 30, 2022 |
December 31, 2021 |
||||||||||||||
| Financial assets |
||||||||||||||||||
| Bonds* |
other financial assets at amortized cost | |||||||||||||||||
| Accounts receivable |
other financial assets at amortized cost | |||||||||||||||||
| Other current/non-current assets |
other financial assets at amortized cost | |||||||||||||||||
| |
|
|
|
|
|
|
|
|||||||||||
| Total financial assets** |
||||||||||||||||||
| |
|
|
|
|
|
|
|
|||||||||||
| Financial liabilities |
||||||||||||||||||
| Accounts payable |
other financial liabilities at amortized cost | |||||||||||||||||
| Other current liabilities |
other financial liabilities at amortized cost | |||||||||||||||||
| Other financial liabilities |
At fair value through profit or loss |
|||||||||||||||||
| |
|
|
|
|
|
|
|
|||||||||||
| Total financial liabilities |
||||||||||||||||||
| |
|
|
|
|
|
|
|
|||||||||||
| * | Bonds are classified within Other financial assets. |
| ** | Financial assets, other than cash and cash equivalents. |
The carrying value of financial instruments, such as cash and cash equivalents, deposits, accounts receivable and accounts payable approximate their fair value based on the short-term maturities of these instruments. The fair values of the financial assets and liabilities are included at the amount at which the instrument could be exchanged in a current transaction between willing parties, other than in a forced or liquidation sale.
The following methods and assumptions were used to estimate the fair values: All financial assets, except for derivatives, which are categorized Level 2, are categorized Level 1 and therefore are valued using quoted (unadjusted) market prices. All financial liabilities are also categorized Level 1.
1
7
Other financial
liabilities is 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 measured the warrants at fair value
by
using the closing price of warrants at NASDAQ. The warrants were measured in each reporting period. Changes in the fair value were recognized in the Company’s consolidated statement of profit or loss as financial income or expense, as appropriate. The warrants were classified as level 1. Refer to note 7 for further details.16. Events occurring after the reporting period
The Company evaluated subsequent events for recognition or disclosure through August 9, 2022.
After the reporting period, the Group issued 0.4 million shares under the ATM agreement with SVB Securities LLC and collected a gross amount of €3.7 million ($3.8 million).
18
MANAGEMENT’S 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 and
six-months
period ended June 30, 2022 and 2021 included in this interim report. You should also read our operating and financial review and prospect and our Consolidated Financial Statements for fiscal year 2021, and the notes thereto, in our Annual Report on Form 20-F
for the year ended December 31, 2021, filed with the SEC on March 23, 2022 (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 focus is the generation of novel therapeutic options for solid tumor patients. Solid tumors constitute the majority of all cancers. Relapsed and/or refractory solid tumor patients have a significant unmet medical need. We believe that by identifying true cancer targets and the right TCRs, we will be well positioned to transform current solid tumor treatment paradigms by delivering cellular and bispecific product candidates that have the potential to improve the lives of cancer patients.
One of the challenges of effectively treating solid tumors is the lack of cancer-specific targets. By utilizing
TCR-based
therapeutics, we are capable of directing T cells not only to targets on the surface of the cancer cell, but also to intracellular cancer targets that are not accessible through classical antibody-based or CAR-T
therapies. We have developed a suite of proprietary technologies to identify what we refer to as “true targets” and “right TCRs.” True targets are (i) naturally occurring at significant levels on native tumor tissue, and (ii) highly specific to cancer cells. Right TCRs are (i) high-affinity TCRs, and (ii) highly specific to the respective cancer target, with no or minimized cross-reactivities to healthy tissues. We believe that the elucidation of these targets provides us the opportunity to develop a pipeline of
novel TCR-based product
candidates that can generate a meaningful therapeutic impact on the lives of cancer patients by going beyond an incremental clinical benefit. We are developing our targeted immunotherapy product candidates through two distinct treatment modalities: Adoptive Cell Therapies (“ACT”) and antibody-like Bispecifics. Each is designed with distinct attributes to produce the desired therapeutic effect for patients at different disease stages and with different types of tumors. Our current proprietary pipeline comprises seven therapeutic programs, three of which are being evaluated in clinical trials. In addition, we are collaborating with world-leading partners, including Genmab, Bristol-Myers Squibb and GlaxoSmithKline, to develop ten additional therapeutic programs covering ACT and Bispecifics. 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 upfront payments from our collaboration partners.
We have assembled a team of 388 FTEs as of June 30, 2022.
Through June 30, 2022 we have raised approximately €820 million in total through licensing payments from our collaborators and through private and public placements of securities. We are holding Cash and cash equivalents and Other financial assets of €324.4 million as of June 30, 2022. 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. Despite the net income that we generated in the six months ended June 30, 2022, 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.
Recent Developments
Business Impact of the
COVID-19
Pandemic In December 2019, a novel strain of coronavirus
(“COVID-19”)
emerged. In response, many countries and businesses still institute travel restrictions, quarantines, and office closures. The extent of the pandemic and governmental responses may impact our ability to obtain raw materials and equipment used for research and development, obtain sufficient additional funds to finance our operations, and conduct clinical trials, any of which could materially and adversely affect our business. Management enacted significant measures to protect the Group’s supply chain, employees, and the execution of clinical trials and continues to monitor the situation. To date, the pandemic has not significantly impacted the Group. The ongoing spread of
COVID-19
may in the future negatively impact the Group’s ability to conduct clinical trials, including potential delays and restrictions on the Group’s ability to recruit and retain patients, and the availability of principal investigators and healthcare employees. COVID-19
could also affect the operations of contract research organizations, which may also result in delays or disruptions in the supply of product candidates. Given the current situation we do not expect significant negative impacts on the Group’s activities in the future, but variants of COVID-19
could limit the impact of vaccines and lead to negative impacts on the Group’s activities. Initiation of Phase 1 Clinical Trial to Evaluate Lead TCR Bispecific IMA401 in Patients with Advanced Solid Tumors
Patient enrolment for IMA401 Phase 1 trial started at the first clinical site in Germany. The study will evaluate safety, tolerability, and initial anti-tumor activity of IMA401 in patients with recurrent and/or refractory solid tumors. IMA401 targets MAGEA4/8 and will be developed in collaboration with Bristol Myers Squibb.
First Patient Treated with ACTengine
®
IMA203 TCR-T
in Combination with Checkpoint Inhibitor Opdivo®
(nivolumab) in Patients with Advanced Solid Tumors In May 2022, Immatics dosed the first patient in IMA203 and nivolumab combination Phase 1b dose expansion cohort. The Phase 1b dose expansion cohort will evaluate safety, biological activity and initial anti-tumor activity of IMA203
TCR-T
targeting PRAME in combination with nivolumab1, a PD-1
immune checkpoint inhibitor, in patients with multiple solid tumors. Initiation of the combination treatment followed positive interim results from the IMA203 monotherapy Phase 1a dose escalation cohort and determination of the provisional recommended phase 2 dose. Expansion of Strategic Alliance to Develop Gamma Delta Allogeneic Cell Therapy Programs with Bristol Myers Squibb
On June 1, 2022, Immatics entered into a multi-program collaboration with Bristol Myers Squibb to develop allogeneic programs. Immatics received an upfront payment of $60 million and is eligible for up to $700 million per Bristol Myers Squibb program through milestone payments as well as additional tiered royalties. Under the collaboration agreement, Bristol Myers Squibb receives access to Immatics’ proprietary gamma delta T cell-derived allogeneic Adoptive Cell Therapy (ACT) platform, ACTallo programs. Both companies have an option to develop up to four additional programs each under the collaboration. Immatics may also develop additional allogeneic programs based on its ACTallo
TCR-T/CAR-T
®
, for application with either up to 4 TCR-T
targets based on the 2019 collaboration agreement or CAR-T
targets. Immatics receives access to Bristol Myers Squibb’s next-generation technologies. The companies will work together to develop and commercialize two allogeneic Bristol Myers Squibb TCR-T/CAR-T
®
platform outside of the collaboration. Also, Immatics and Bristol Myers Squibb expanded their autologous T cell receptor-based therapy
(TCR-T)
collaboration signed in 2019 by including one additional TCR-T
target discovered by Immatics. Immatics received a payment of $20 million and is eligible for milestone payments as well as royalties. Strategic Research Collaboration and Licensing Agreement to Combine Gamma-Delta T Cell Adoptive Cell Therapies and Gene Editing for the Treatment of Cancer
Immatics entered a strategic research collaboration and licensing agreement with Editas Medicine, Inc., combining gamma delta T cell adoptive cell therapies and gene editing to develop medicines for the treatment of cancer. As part of the agreement, Immatics gains
non-exclusive
rights to Editas Medicine’s CRISPR technology and intellectual property. 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, including with BMS, Genmab and GSK.
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 measurement basis, in accordance with our accounting policy as described further under “—Critical Accounting Policies and Significant Judgments and Estimates.”
cost-to-cost
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 four of our five 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. The collaboration agreements resulted in €399.2 million of upfront cash payments through June 30, 2022. As part of the agreements, we contribute our 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 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 on 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 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 immuno-oncology therapies to cancer patients:
| • | advancing the proprietary pipeline of product candidates focusing on ACTengine and TCR Bispecifics; |
| • | enhancing ACT manufacturing capabilities; |
| • | disrupting the tumor microenvironment through combination therapies, next-generation technologies and novel target classes; |
| • | developing novel personalized multi-TCR-T |
| • | maintaining and enhancing the competitive edge of our target and TCR technology platforms; |
| • | leveraging existing collaborations with Genmab, BMS and GSK and establish additional value-maximizing strategic collaborations and |
| • | expanding 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 in humans 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; |
| • | manufacturers 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 Bispecifics-based 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 both Financial income and Financial expense. Financial income results primarily from foreign exchange gains. Our financial expense consists of interest expense related to lease liabilities and foreign exchange losses. Additionally, our warrants are classified as Other financial liabilities. The change in fair value of warrant liabilities consists of the change in fair value of these warrants.
Results of Operations
Comparison of the Three and Six Months Ended June 30, 2022 and June 30, 2021
The following table summarizes our consolidated statements of operations for each period presented:
Three months ended June 30, |
Six months ended June 30, |
|||||||||||||||
2022 |
2021 |
2022 |
2021 |
|||||||||||||
(euros in thousands, except share and per share data) |
||||||||||||||||
| Revenue from collaboration agreements |
€ | 17,215 | € | 5,189 | € | 120,123 | € | 12,592 | ||||||||
| Research and development expenses |
(25,216 | ) | (20,340 | ) | (50,360 | ) | (43,389 | ) | ||||||||
| General and administrative expenses |
(8,683 | ) | (8,271 | ) | (17,961 | ) | (16,702 | ) | ||||||||
| Other income |
27 | 26 | 32 | 265 | ||||||||||||
| |
|
|
|
|
|
|
|
|||||||||
| Operating result |
(16,657 |
) |
(23,396 |
) |
51,834 |
(47,234 |
) | |||||||||
| Financial income |
7,015 | 213 | 8,774 | 3,101 | ||||||||||||
| Financial expenses |
(407 | ) | (629 | ) | (1,524 | ) | (1,277 | ) | ||||||||
| Change in fair value of warrant liabilities |
(2,786 | ) | (2,722 | ) | 13,743 | (3,936 | ) | |||||||||
| |
|
|
|
|
|
|
|
|||||||||
| Financial result |
3,822 |
(3,138 |
) |
20,993 |
(2,112 |
) | ||||||||||
| |
|
|
|
|
|
|
|
|||||||||
| Profit/(loss) before taxes |
(12,835 |
) |
(26,534 |
) |
72,827 |
(49,346 |
) | |||||||||
| Taxes on income |
(1,145 | ) | — | (1,145 | ) | — | ||||||||||
| |
|
|
|
|
|
|
|
|||||||||
| Net profit/(loss) |
€ |
(13,980 |
) |
€ |
(26,534 |
) |
€ |
71,682 |
€ |
(49,346 |
) | |||||
| |
|
|
|
|
|
|
|
|||||||||
| Net profit/(loss) per share: |
||||||||||||||||
| Basic |
(0.22 | ) | (0.42 | ) | 1.12 | (0.78 | ) | |||||||||
| Diluted |
(0.22 | ) | (0.42 | ) | 1.11 | (0.78 | ) | |||||||||
| Weighted average shares outstanding: |
||||||||||||||||
| Basic |
64,915,600 | 62,909,095 | 63,932,449 | 62,908,945 | ||||||||||||
| Diluted |
64,915,600 | 62,909,095 | 64,477,256 | 62,908,945 | ||||||||||||
Revenue from Collaboration Agreements
The following table summarizes our collaboration revenue for the periods indicated:
Three Months Ended June 30, |
Six Months Ended June 30, |
|||||||||||||||
2022 |
2021 |
2022 |
2021 |
|||||||||||||
(Euros in thousands) |
||||||||||||||||
| Revenue from collaboration agreements: |
||||||||||||||||
| Amgen |
€ | — | € | 260 | € | — | € | 517 | ||||||||
| Genmab |
4,125 | 2,105 | 7,044 | 4,341 | ||||||||||||
| BMS |
12,107 | 1,297 | 110,532 | 4,590 | ||||||||||||
| GSK |
983 | 1,527 | 2,547 | 3,144 | ||||||||||||
| |
|
|
|
|
|
|
|
|||||||||
Total revenue from collaboration agreements |
€ 17,215 |
€ 5,189 |
€ 120,123 |
€ 12,592 |
||||||||||||
| |
|
|
|
|
|
|
|
|||||||||
Our Revenue from collaboration agreements increased from €5.2 million for the three months ended June 30, 2021 to €17.2 million for the three months ended June 30, 2022. The increase in revenue of €12.0 million mainly resulted from the collaborations with BMS and Genmab. The Amgen collaboration agreement was terminated in October 2021. As a result, we did not recognize any revenue for this collaboration for the three months ended June 30, 2022.
Our Revenue from collaboration agreements increased from €12.6 million for the six months ended June 30, 2021 to €120.1 million for the six months ended June 30, 2022. The increase in revenue of €107.5 million mainly resulted from the collaborations with BMS. The Revenue from collaboration agreements with BMS includes the revenue related to the license for IMA401 amounting to €91.3 million and €19.2 million revenue recognized on a method. The Amgen collaboration agreement was terminated in October 2021. As a result, we did not recognize any revenue for this collaboration for the six months ended June 30, 2022.
right-to-use
cost-to-cost
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 June 30, |
Six Months Ended June 30, |
|||||||||||||||
2022 |
2021 |
2022 |
2021 |
|||||||||||||
(Euros in thousands) |
||||||||||||||||
| Direct external research and development expenses by program: |
||||||||||||||||
| ACT Programs |
€ | 3,910 | € | 3,338 | € | 8,667 | € | 7,393 | ||||||||
| TCR Bispecifics Programs |
1,028 | 1,027 | 2,090 | 3,380 | ||||||||||||
| Other programs |
2,010 | 723 | 3,232 | 1,521 | ||||||||||||
| |
|
|
|
|
|
|
|
|||||||||
| Sub-total direct external expenses |
€ |
6,947 |
€ |
5,088 |
€ |
13,990 |
€ |
12,294 |
||||||||
| |
|
|
|
|
|
|
|
|||||||||
| Indirect research and development expenses: |
||||||||||||||||