Exhibit Number |
Description | |
| 99.1 | Immatics N.V. interim report for the three and six-month periods ended June 30, 2023. | |
| 99.2 | Press release dated August 17, 2023. | |
| 99.3 | Corporate presentation dated August 17, 2023 | |
| 101.INS | Inline XBRL Taxonomy Extension Instance Document | |
| 101.SCH | Inline XBRL Taxonomy Extension Schema Document | |
| 101.CAL | Inline XBRL Taxonomy Extension Calculation Linkbase Document | |
| 101.DEF | Inline XBRL Taxonomy Extension Definition Linkbase Document | |
| 101.LAB | Inline XBRL Taxonomy Extension Label Linkbase Document | |
| 101.PRE | Inline XBRL Taxonomy Extension Presentation Linkbase Document | |
| 104 | Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101). | |
IMMATICS N.V. | ||||||
| Date: August 17, 2023 | by: | /s/ Harpreet Singh | ||||
| Harpreet Singh | ||||||
| Chief Executive Officer | ||||||
Three months ended June 30, |
Six months ended June 30, |
|||||||||||||||||||
Notes |
2023 |
2022 |
2023 |
2022 |
||||||||||||||||
(Euros in thousands, except per share data) |
(Euros in thousands, except per share data) |
|||||||||||||||||||
Revenue from collaboration agreements |
5 | |||||||||||||||||||
Research and development expenses |
( |
) | ( |
) | ( |
) | ( |
) | ||||||||||||
General and administrative expenses |
( |
) | ( |
) | ( |
) | ( |
) | ||||||||||||
Other income |
||||||||||||||||||||
Operating result |
( |
) |
( |
) |
( |
) |
||||||||||||||
Change in fair value of liabilities for warrants |
6 | ( |
) | ( |
) | ( |
) | |||||||||||||
Other financial income |
6 | |||||||||||||||||||
Other financial expenses |
6 | ( |
) | ( |
) | ( |
) | ( |
) | |||||||||||
Financial result |
( |
) |
( |
) |
||||||||||||||||
Profit/(loss) before taxes |
( |
) |
( |
) |
( |
) |
||||||||||||||
Taxes on income |
7 | ( |
) | ( |
) | |||||||||||||||
Net profit/(loss) |
( |
) |
( |
) |
( |
) |
||||||||||||||
Net profit/(loss) per share: |
17 | |||||||||||||||||||
Basic |
( |
) | ( |
) | ( |
) | ||||||||||||||
Diluted |
( |
) | ( |
) | ( |
) | ||||||||||||||
Three months ended June 30, |
Six months ended June 30, |
|||||||||||||||||||
Notes |
2023 |
2022 |
2023 |
2022 |
||||||||||||||||
(Euros in thousands) |
(Euros in thousands) |
|||||||||||||||||||
| Net profit/(loss) |
( |
) |
( |
) |
( |
) |
||||||||||||||
| Other comprehensive income/(loss) |
||||||||||||||||||||
| Items that may be reclassified subsequently to profit or loss |
||||||||||||||||||||
| Currency translation differences from foreign operations |
14 | ( |
) | |||||||||||||||||
| |
|
|
|
|
|
|
|
|||||||||||||
| Total comprehensive income/(loss) for the year |
( |
) |
( |
) |
( |
) |
||||||||||||||
| |
|
|
|
|
|
|
|
|||||||||||||
As of |
||||||||||||
Notes |
June 30, 2023 |
December 31, 2022 |
||||||||||
(Euros in thousands) |
||||||||||||
Assets |
||||||||||||
Current assets |
||||||||||||
Cash and cash equivalents |
16 | |||||||||||
Other financial assets |
16 | |||||||||||
Accounts receivables |
16 | |||||||||||
Other current assets |
9 | |||||||||||
Total current assets |
||||||||||||
Non-current assets |
||||||||||||
Property, plant and equipment |
10 | |||||||||||
Intangible assets |
10 | |||||||||||
Right-of-use |
10 | |||||||||||
Other non-current assets |
9 | |||||||||||
Total non-current assets |
||||||||||||
Total assets |
||||||||||||
Liabilities and shareholders’ equity |
||||||||||||
Current liabilities |
||||||||||||
Provisions |
11 | |||||||||||
Accounts payables |
12 | |||||||||||
Deferred revenue |
5 | |||||||||||
Liabilities for warrants |
16 | |||||||||||
Lease liabilities |
16 | |||||||||||
Other current liabilities |
13 | |||||||||||
Total current liabilities |
||||||||||||
Non-current liabilities |
||||||||||||
Deferred revenue |
5 | |||||||||||
Lease liabilities |
16 | |||||||||||
Other non-current liabilities |
||||||||||||
Total non-current liabilities |
||||||||||||
Shareholders’ equity |
||||||||||||
Share capital |
14 | |||||||||||
Share premium |
14 | |||||||||||
Accumulated deficit |
14 | ( |
) | ( |
) | |||||||
Other reserves |
14 | ( |
) | ( |
) | |||||||
Total shareholders’ equity |
||||||||||||
Total liabilities and shareholders’ equity |
||||||||||||
Six months ended June 30, |
||||||||
2023 |
2022 |
|||||||
(Euros in thousands) |
||||||||
Cash flows from operating activities |
||||||||
Net profit/(loss) |
( |
) | ||||||
Taxes on income |
||||||||
Profit/(loss) before tax |
( |
) |
||||||
Adjustments for: |
||||||||
Interest income |
( |
) | ( |
) | ||||
Depreciation and amortization |
||||||||
Interest expenses |
||||||||
Equity settled share-based payment |
||||||||
Net foreign exchange differences and expected credit losses |
( |
) | ||||||
Change in fair value of liabilities for warrants |
( |
) | ||||||
Changes in: |
||||||||
Decrease/(increase) in accounts receivables |
( |
) | ||||||
Decrease/(increase) in other assets |
( |
) | ||||||
(Decrease)/increase in deferred revenue, accounts payables and other liabilities |
( |
) | ||||||
Interest received |
||||||||
Interest paid |
( |
) | ( |
) | ||||
Income tax paid |
||||||||
Net cash (used in)/provided by operating activities |
( |
) |
||||||
Cash flows from investing activities |
||||||||
Payments for property, plant and equipment |
( |
) | ( |
) | ||||
Payments for intangible assets |
( |
) | ( |
) | ||||
Proceeds from disposal of property, plant and equipment |
||||||||
Payments for investments classified in Other financial assets |
( |
) | ( |
) | ||||
Proceeds from maturity of investments classified in Other financial assets |
||||||||
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 |
( |
) | ( |
) | ||||
Repayment of lease liabilities |
( |
) | ( |
) | ||||
Net cash provided by/(used in) financing activities |
||||||||
Net (decrease)/increase in cash and cash equivalents |
( |
) |
||||||
Cash and cash equivalents at beginning of the year |
||||||||
Effects of exchange rate changes and expected credit losses on cash and cash equivalents |
( |
) | ||||||
Cash and cash equivalents at end of the year |
||||||||
| (Euros in thousands) |
Notes |
Share capital |
Share premium |
Accumulated deficit |
Other reserves |
Total share- holders’ equity |
||||||||||||||||||
| Balance as of January 1, 2022 |
( |
) |
( |
) |
||||||||||||||||||||
| Other comprehensive income |
— | — | — | |||||||||||||||||||||
| Net profit |
— | — | — | |||||||||||||||||||||
| Comprehensive income for the year |
— |
— |
||||||||||||||||||||||
| Equity-settled share-based compensation |
8 | — | — | — | ||||||||||||||||||||
| Share options exercised |
— | — | — | |||||||||||||||||||||
| Issue of share capital – net of transaction costs |
14 | — | — | |||||||||||||||||||||
| |
|
|
|
|
|
|
|
|
|
|||||||||||||||
| Balance as of June 30, 2022 |
( |
) |
( |
) |
||||||||||||||||||||
| |
|
|
|
|
|
|
|
|
|
|||||||||||||||
| Balance as of January 1, 2023 |
( |
) |
( |
) |
||||||||||||||||||||
| Other comprehensive income |
— | — | — | |||||||||||||||||||||
| Net loss |
— | — | ( |
) | — | ( |
) | |||||||||||||||||
| Comprehensive loss for the year |
— |
— |
( |
) |
( |
) | ||||||||||||||||||
| Equity-settled share-based compensation |
8 | — | — | — | ||||||||||||||||||||
| Share options exercised |
— | — | — | |||||||||||||||||||||
| Issue of share capital – net of transaction costs |
14 | — | — | |||||||||||||||||||||
| |
|
|
|
|
|
|
|
|
|
|||||||||||||||
| Balance as of June 30, 2023 |
( |
) |
( |
) |
||||||||||||||||||||
| |
|
|
|
|
|
|
|
|
|
|||||||||||||||
Six months ended June 30, 2022 |
||||||||||||
As reported |
Adjustment |
As revised |
||||||||||
Net foreign exchange differences and expected credit losses |
( |
) | ( |
) | ||||||||
Net cash provided by/(used in) operating activities |
( |
) | ||||||||||
Net cash (used in)/provided by investing activities |
( |
) | ( |
) | ||||||||
Net cash (used in)/provided by 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 |
||||||||||||
Three months ended June 30, |
Six months ended June 30, |
|||||||||||||||
2023 |
2022 |
2023 |
2022 |
|||||||||||||
(Euros in thousands) |
(Euros in thousands) |
|||||||||||||||
| Genmab, Denmark |
||||||||||||||||
| BMS, United States |
||||||||||||||||
| GSK, United Kingdom |
||||||||||||||||
| |
|
|
|
|
|
|
|
|||||||||
| Total |
||||||||||||||||
| |
|
|
|
|
|
|
|
|||||||||
As of |
||||||||
June 30, 2023 |
December 31, 2022 |
|||||||
(Euros in thousands) |
||||||||
| Current |
||||||||
| Non-current |
||||||||
| |
|
|
|
|||||
| Total |
||||||||
| |
|
|
|
|||||
Three months ended June 30, |
Six months ended June 30, |
|||||||||||||||
2023 |
2022 |
2023 |
2022 |
|||||||||||||
(Euros in thousands) |
(Euros in thousands) |
|||||||||||||||
| Interest income |
||||||||||||||||
| Foreign currency gains |
||||||||||||||||
| |
|
|
|
|
|
|
|
|||||||||
| Other financial income |
||||||||||||||||
| |
|
|
|
|
|
|
|
|||||||||
| Interest expenses |
( |
) | ( |
) | ( |
) | ( |
) | ||||||||
| Foreign currency losses |
( |
) | ( |
) | ( |
) | ( |
) | ||||||||
| Losses on financial instruments |
( |
) | ( |
) | ||||||||||||
| |
|
|
|
|
|
|
|
|||||||||
| Other financial expenses |
( |
) |
( |
) |
( |
) |
( |
) | ||||||||
| Change in fair value of liabilities for warrants |
( |
) | ( |
) | ( |
) | ||||||||||
| Financial result |
( |
) |
( |
) |
||||||||||||
| |
|
|
|
|
|
|
|
|||||||||
2023 |
||||||||
Weighted average exercise price in USD |
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) |
||||||||
2023 |
||||||||
Weighted average exercise price in USD |
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) |
||||||||
As of April 3, 2023 |
As of June 27, 2023 |
|||||||
| Exercise price in USD |
$ | $ | ||||||
| Underlying share price in USD |
$ | $ | ||||||
| Volatility |
% | % | ||||||
| Time period (years) |
||||||||
| Risk free rate |
% | % | ||||||
| Dividend yield |
% | % | ||||||
2023 |
||||||||
Weighted average exercise price in USD |
Number |
|||||||
| Service Options outstanding on January 1, |
||||||||
| Service Options granted in 2023 |
||||||||
| 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) |
||||||||
2023 |
||||||||
Weighted average exercise price in USD |
Number |
|||||||
| PSUs outstanding on January 1, |
||||||||
| PSUs granted in 2023 |
||||||||
| PSUs forfeited |
||||||||
| PSUs outstanding on June 30, |
||||||||
| PSUs exercisable on June 30, |
||||||||
| Weighted average remaining contract life (years) |
||||||||
Three months ended June 30, |
Six months ended June 30, |
|||||||||||||||
2023 |
2022 |
2023 |
2022 |
|||||||||||||
(Euros in thousands) |
(Euros in thousands) |
|||||||||||||||
| Research and development expenses |
( |
) | ( |
) | ( |
) | ( |
) | ||||||||
| General and administrative expenses |
( |
) | ( |
) | ( |
) | ( |
) | ||||||||
| |
|
|
|
|
|
|
|
|||||||||
| Total |
( |
) |
( |
) |
( |
) |
( |
) | ||||||||
| |
|
|
|
|
|
|
|
|||||||||
As of |
||||||||
June 30, 2023 |
December 31, 2022 |
|||||||
(Euros in thousands) |
||||||||
| Prepaid expenses |
||||||||
| Value added tax receivables |
||||||||
| Other assets |
||||||||
| |
|
|
|
|||||
| Total |
||||||||
| |
|
|
|
|||||
As of |
||||||||
June 30, 2023 |
December 31, 2022 |
|||||||
(Euros in thousands) |
||||||||
| Prepaid expenses |
||||||||
| Other assets |
||||||||
| |
|
|
|
|||||
| Total |
||||||||
| |
|
|
|
|||||
As of |
||||||||
June 30, 2023 |
December 31, 2022 |
|||||||
(Euros in thousands) |
||||||||
| Provision for bonuses |
||||||||
| |
|
|
|
|||||
| Total |
||||||||
| |
|
|
|
|||||
As of |
||||||||
June 30, 2023 |
December 31, 2022 |
|||||||
(Euros in thousands) |
||||||||
| Accounts payables |
||||||||
| Accrued liabilities |
||||||||
| |
|
|
|
|||||
| Total |
||||||||
| |
|
|
|
|||||
As of |
||||||||
June 30, 2023 |
December 31, 2022 |
|||||||
(Euros in thousands) |
||||||||
| Income tax liability |
||||||||
| Payroll tax |
||||||||
| Accrual for vacation |
||||||||
| Accrued bonuses |
— | |||||||
| Other liabilities |
||||||||
| |
|
|
|
|||||
| Total |
||||||||
| |
|
|
|
|||||
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 |
June 30, 2023 |
|||||||||||||||
Current/non-current assets |
||||||||||||||||||||
Cash and cash equivalents |
— | — | — | |||||||||||||||||
Short-term deposits* |
— | — | — | |||||||||||||||||
Bonds* |
— | — | — | — | — |
|||||||||||||||
Accounts receivables |
— | — | — | |||||||||||||||||
Other current/non-current assets |
— | — | — | |||||||||||||||||
Current/non-current liabilities |
||||||||||||||||||||
Accounts payable |
— | — | — | |||||||||||||||||
Other current liabilities |
— | — | — | |||||||||||||||||
Liabilities for warrants |
— | — | — | |||||||||||||||||
Lease liabilities |
— | — | — | |||||||||||||||||
Total |
— | — |
||||||||||||||||||
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 |
December 31, 2022 |
|||||||||||||||
Current/non-current assets |
||||||||||||||||||||
Cash and cash equivalents |
— | — | — | |||||||||||||||||
Short-term deposits* |
— | — | — | |||||||||||||||||
Bonds* |
— | — | — | |||||||||||||||||
Accounts receivables |
— | — | — | |||||||||||||||||
Other current/non-current assets |
— | — | — | |||||||||||||||||
Current/non-current liabilities |
||||||||||||||||||||
Accounts payable |
— | — | — | |||||||||||||||||
Other current liabilities |
— | — | — | |||||||||||||||||
Liabilities for warrants |
— | — | — | |||||||||||||||||
Lease liabilities |
— | — | — | |||||||||||||||||
Total |
— | — |
||||||||||||||||||
| * | “Short-term deposits” and “Bonds” are classified within the balance sheet item “Other financial assets” |
As of |
||||||||||||||||
June 30, 2023 |
December 31, 2022 |
|||||||||||||||
Euros in thousands |
Carrying amount |
Fair value |
Carrying amount |
Fair value |
||||||||||||
Bonds |
— | — | ||||||||||||||
Total |
— |
— |
||||||||||||||
Three months ended June 30, |
Six months ended June 30, |
|||||||||||||||
2023 |
2022 |
2023 |
2022 |
|||||||||||||
| (Euros in thousands, except share and per share data) |
(Euros in thousands, except share and per share data) |
|||||||||||||||
| Net profit/(loss): |
( |
) |
( |
) |
( |
) |
||||||||||
| Basic |
( |
) | ( |
) | ( |
) | ||||||||||
| Diluted |
( |
) | ( |
) | ( |
) | ||||||||||
| Weighted average shares outstanding: |
||||||||||||||||
| Basic |
||||||||||||||||
| Diluted |
||||||||||||||||
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 month-period ended June 30, 2023 and 2022 included in this interim report. You should also read our operating and financial review and prospects and our Consolidated Financial Statements for fiscal year 2022, and the notes thereto, in our Annual Report on Form 20-F for the year ended December 31, 2022, filed with the SEC on March 22, 2023 (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 a variety of 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”), Editas Medicine and Genmab, to develop multiple 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 payments from our collaboration partners.
We have assembled a team of 418 and 380 FTEs as of June 30, 2023 and December 31, 2022, respectively.
Through June 30, 2023 we have raised approximately €981.7 million 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 €347.6 million as of June 30, 2023. 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 conflict between Russia and Ukraine has resulted, and is expected to 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 or Ukraine, it does not expect that the ongoing war 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 in Germany, such as new tax legislation, economic sanctions and comparable measures. In addition, other geopolitical instabilities might impact the Group in the future.
During the six months ended June 30, 2023, Silicon Valley Bank as well as Credit Suisse, two large banks, as well as other smaller banks, were subject to liquidity problems. The Group does not hold deposits or securities with any of the affected banks. While the banking system remained stable overall, we will continue to closely monitor the situation.
While there is currently no material direct risk identified for the Group from COVID-19, Immatics will continue to closely monitor the effects of the pandemic as well.
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:
| • | Realize the full multi-cancer opportunity of PRAME. We believe PRAME (Preferentially Expressed Antigen in Melanoma) is one of the most promising and most prevalent, clinically validated solid tumor targets known to date. To leverage its full potential and maximize patient reach, we are: (1) focusing and accelerating the development of our ACTengine IMA203 TCR-T towards pivotal trials, (2) expanding the patient population that might benefit from a PRAME-targeting therapy by developing an off-the-shelf biologic TCER IMA402 with a different mechanism of action without the requirement for administration at specialized medical centers and (3) expanding beyond HLA-A*02 by investigating new target-TCR pairs for PRAME epitopes binding to other HLA types. |
| • | Advance our pipeline of innovative ACTengine TCR-T product candidates. In addition to our most advanced TCR-T product candidate ACTengine IMA203, our pipeline is strengthened by innovative cell therapy programs in development. ACTengine IMA204 is directed against the novel tumor stroma target COL6A3 that is highly prevalent across many different solid tumor types and provides a promising and innovate therapeutic opportunity for a broad patient population as monotherapy or in combination with TCR-T cells directed against targets presented on tumor cells. IMA204 uses an affinity maturated CD8-independent, next-generation TCR that engages both CD4 and CD8 T cells without the need of CD8 co-transduction. Moreover, we continue to actively investigate multiple other next-generation enhancement and combination strategies to render ACTengine T cells even more potent to combat solid tumors and enhance tolerability and ease of use of our product candidates. |
| • | Advance our pipeline of next-generation, half-life extended TCR Bispecifics. In addition to PRAME TCER IMA402 which entered clinical development in August 2023, we have a broad portfolio of clinical and preclinical TCR Bispecifics. Phase 1 clinical development commenced in May 2022 for our most advanced TCER program IMA401 targeting MAGEA4/8. IMA401 is being developed in collaboration with BMS and we seek to deliver clinical PoC for IMA401 and thus our TCER platform as fast as possible. We also continue development of several innovative preclinical TCER product candidates against so far undisclosed targets for our proprietary and/or partnered pipeline. IMA403 is in advanced preclinical stage with PoC studies ongoing. Additionally, TCER engineering and preclinical testing is ongoing for further TCER candidates, IMA40x, targeting peptides presented by HLA-A*02:01 and other HLA-types. 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. |
| • | Further enhance our cell therapy manufacturing capabilities. Our proprietary ACTengine manufacturing process is generating TCR-T cells that have been shown to achieve a high rate of objective responses, infiltrate the patient’s tumor and function in the solid tumor microenvironment. With a manufacturing time of approximately one week and an accelerated product release time, we are aiming at shortening the vein-to-vein time and to provide products to patients as fast as possible. We have implemented several manufacturing enhancements in our IMA203 Phase 1b trial (including monocyte depletion) that enhanced key features of the cell product and were focused on robustness, quality, and speed of product release. We continue to implement minor improvements to prepare for pivotal trials and potential commercialization. We are currently expanding our cell therapy manufacturing capabilities with construction of a state-of-the-art GMP manufacturing facility for registration-directed and commercial production of ACTengine TCR-T products, including IMA203. The manufacturing facility is expected to be operational in 2024. |
| • | Develop allogeneic off-the-shelf cell therapies. We aim to increase the commercial opportunity of cell therapies by supplying products to patients more quickly and at lower cost with our off-the-shelf cell therapy approach, ACTallo. ACTallo is our proprietary allogeneic adoptive cell therapy platform based on gamma delta T cells sourced from healthy donors and designed to create hundreds of doses from one single donor leukapheresis. In June 2022, we entered into strategic collaborations with Bristol Myers Squibb and Editas Medicine with the goal to develop transformative next-generation allogeneic gamma delta TCR-T/CAR-T programs with enhanced persistence, safety and potency by combining our proprietary ACTallo platform with Bristol Myers Squibb’s next-gen technologies and Editas Medicine’s CRISPR gene editing technology. |
| • | 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 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 through upfront payments and potential milestone payments and royalties for product candidates that our partners successfully advance into and through clinical development and towards commercial launch. We are in discussions to potentially establish a strategic collaboration that may encompass any, some or all of the following: exclusive development and out-licensing agreement of therapeutics against a limited number of preclinical-stage TCER targets, limited access to our XPRESIDENT technology platform and/or the development of combination therapeutics. |
| • | Strengthen our intellectual property portfolio. We intend to continuously build and maintain our intellectual property portfolio.The protection of our intellectual property assets is a foundational element of our ability to not only strengthen our product pipeline, but also to successfully defend and strengthen our position in the field of TCR therapies. |
| • | Enhance the competitive edge of our technology platforms. Our target and TCR discovery platforms XPRESIDENT and XCEPTOR are the foundation for the further strengthening our product pipeline and our position in the field of TCR-based 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 (in contrast to being in silico predicted or identified from cell line cultures), 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 leverage this unique knowledge to develop a pipeline of transformative TCR-based product candidates. Our goal is to maintain and expand our competitive edge in highly differentiated platform technologies aimed at developing additional, better and highly innovative product candidates within shorter development timelines, for mid- and long-term value generation as part of our own or partnered pipeline. |
Portfolio Update
Adoptive Cell Therapy Programs
ACTengine® IMA203: ACTengine® IMA203 TCR-T against PRAME is currently being evaluated in an ongoing Phase 1b dose expansion trial.
| • | As per the latest data cut-off of April 4, 2023, ACTengine® IMA203 TCR-T monotherapy Cohort A showed a 67% confirmed objective response rate (cORR) in an interim clinical update announced on May 2, 2023. The data covered 11 heavily pre-treated patients; the median duration of response was not reached at a median follow-up time of 8.5 months. Patients were infused with IMA203 TCR-T cells at dose level (DL) 4 or DL5 with a mean total infused dose of 3.67x109 TCR-T cells (range 1.30-8.84x109 TCR-T cells). |
| • | Cohort A IMA203 monotherapy TCR-T treatment continues to show manageable tolerability with no high-grade CRS and no ICANS; all 11 patients experienced expected cytopenia (Grade 1-4) associated with lymphodepletion. 10 patients (91%) had a low to moderate (Grade 1-2) cytokine release syndrome (CRS), of which 5 patients (45%) had Grade 1, and 5 patients (45%) had Grade 2 CRS. |
| • | Objective responses were observed independent of tumor type including checkpoint-refractory and BRAF inhibitor-refractory cutaneous melanoma, platinum-resistant ovarian cancer, uveal melanoma, head and neck cancer and synovial sarcoma. Longest duration of responses were observed in cutaneous and uveal melanoma with ongoing responses at 6, 9 and 10 months post infusion at data cut-off. |
| • | IMA203 in combination with nivolumab (Cohort B) has been de-prioritized in the last-line setting. Such a combination is being considered for the front-line setting. |
| • | IMA203CD8 (Cohort C) is a next-generation monotherapy where IMA203 engineered T cells are co-transduced with a CD8αß co-receptor. IMA203CD8 is currently being explored in DL4a (up to 0.8x109 TCR-T cells/m2 BSA). |
| • | Next update on Immatics’ IMA203 Phase 1b cohorts, including the projected clinical development path for PRAME-targeted TCR-T monotherapy towards registration-directed trials is planned for 4Q 2023. Immatics’ IMA203 development strategy to realize the multi-cancer opportunity of targeting PRAME is based on two pillars aimed at: |
| 1. | maximizing speed to market in one to two last-line solid cancer types focusing on cutaneous melanoma, uveal melanoma and potentially other tumor types with high PRAME prevalence where clinical proof-of-concept has been demonstrated, and |
| 2. | broad development with expansion to other cancer types, such as ovarian cancer, uterine cancer, lung cancer, breast cancer, head and neck cancer and other tumor types having a broad patient reach. |
TCR-T pipeline
| • | Earlier this year, Bristol Myers Squibb exercised its first option and entered into a global license agreement with Immatics for the most advanced TCR-T product candidate. As part of the agreement, Immatics received an option payment of $15 million and is eligible for up to $490 million in milestone payments in addition to tiered royalties on net sales of the product. |
TCR Bispecifics Programs
Immatics’ T cell engaging receptor (TCER®) candidates are next-generation, half-life extended TCR Bispecific molecules designed to maximize efficacy while minimizing toxicities in patients through Immatics’ proprietary format using a low-affinity T cell recruiter and a high-affinity TCR domain.
| • | TCER® IMA401 (MAGEA4/8) – Phase 1 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®). MAGEA4 and MAGEA8 are expressed in multiple solid cancers including lung cancer, head and neck cancer, melanoma, ovarian cancer, sarcoma and others. IMA401 is being developed in collaboration with Bristol Myers Squibb. |
| • | TCER® IMA402 (PRAME) – Immatics submitted a clinical trial application (Clinical Trial Application (CTA) is the European equivalent of an Investigational New Drug (IND) application) to the Paul-Ehrlich-Institute (PEI) in April 2023. Following CTA acceptance, Immatics initiated the Phase 1/2 trial investigating the company’s fully owned TCER® candidate IMA402 in patients with recurrent and/or refractory solid tumors in August. Initial focus indications are cutaneous and uveal melanoma, ovarian cancer, lung cancer, uterine cancer and synovial sarcoma, among others. A first clinical data update is planned for 2024. 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®). |
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 and Genmab.
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 three of our four current 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 running of the clinical trial services will not result in a modification of the license.
The collaboration agreements resulted in €412.7 million of payments through June 30, 2023. We received a €13.7 million Opt-in payment from our collaboration partner BMS in 2023. 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 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:
| • | Realize the full multi-cancer opportunity of PRAME by (1) focusing and accelerating the development of our ACTengine IMA203 TCR-T towards pivotal trials, (2) expanding the patient population that might benefit from a PRAME-targeting therapy by developing an off-the-shelf biologic TCER IMA402 and (3) expanding beyond HLA-A*02 by investigating new target-TCR pairs for PRAME epitopes binding to other HLA types; |
| • | Advance our pipeline of innovative ACTengine TCR-T product candidates; |
| • | Advance our pipeline of next-generation, half-life extended TCR Bispecifics; |
| • | Enhance the commercial opportunities of cell therapies; |
| • | Further enhance our cell therapy manufacturing capabilities; |
| • | Leverage the full potential of strategic collaborations; |
| • | Strengthen our intellectual property portfolio; and |
| • | Enhance the competitive edge of our technology platforms. |
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; |
| • | we or our 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 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 both other financial income and other financial expenses. 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. Additionally, our warrants are classified as liabilities for warrants. 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, 2023 and June 30, 2022
The following table summarizes our consolidated statements of operations for each period presented:
| Three months ended June 30, |
Six months ended June 30, |
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| 2023 | 2022 | 2023 | 2022 | |||||||||||||
| (Euros in thousands, except per share data) | (Euros in thousands, except per share data) | |||||||||||||||
| Revenue from collaboration agreements |
22,354 | 17,215 | 32,150 | 120,123 | ||||||||||||
| Research and development expenses |
(27,317 | ) | (25,216 | ) | (54,898 | ) | (50,360 | ) | ||||||||
| General and administrative expenses |
(9,358 | ) | (8,683 | ) | (18,944 | ) | (17,961 | ) | ||||||||
| Other income |
6 | 27 | 948 | 32 | ||||||||||||
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| Operating result |
(14,315 | ) | (16,657 | ) | (40,744 | ) | 51,834 | |||||||||
| Change in fair value of liabilities for warrants |
(13,105 | ) | (2,786 | ) | (5,708 | ) | 13,743 | |||||||||
| Other financial income |
3,954 | 7,015 | 6,748 | 8,774 | ||||||||||||
| Other financial expenses |
(1,144 | ) | (407 | ) | (4,653 | ) | (1,524 | ) | ||||||||
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| Financial result |
(10,295 | ) | 3,822 | (3,613 | ) | 20,993 | ||||||||||
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| Profit/(loss) before taxes |
(24,610 | ) | (12,835 | ) | (44,357 | ) | 72,827 | |||||||||
| Taxes on income |
— | (1,145 | ) | — | (1,145 | ) | ||||||||||
| Net profit/(loss) |
(24,610 | ) | (13,980 | ) | (44,357 | ) | 71,682 | |||||||||
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| Net profit/(loss) per share: |
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| Basic |
(0.32 | ) | (0.22 | ) | (0.58 | ) | 1.12 | |||||||||
| Diluted |
(0.32 | ) | (0.22 | ) | (0.58 | ) | 1.11 | |||||||||
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, |
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| 2023 | 2022 | 2023 | 2022 | |||||||||||||
| (Euros in thousands) | (Euros in thousands) | |||||||||||||||
| Genmab, Denmark |
915 | 4,125 | 215 | 7,044 | ||||||||||||
| BMS, United States |
21,439 | 12,107 | 31,935 | 110,532 | ||||||||||||
| GSK, United Kingdom |
— | 983 | — | 2,547 | ||||||||||||
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| Total |
22,354 | 17,215 | 32,150 | 120,123 | ||||||||||||
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Our Revenue from collaboration agreements increased from €17.2 million for the three months ended June 30, 2022 to €22.4 million for the three months ended June 30, 2023. The increase in revenue of €5.2 million is mainly due to the revenue recognized regarding the BMS Opt-in payment of €13.7 million for the three months ended June 30, 2023, partially offset by lower revenue from the Genmab collaboration due to lower progress of the collaboration.
Our Revenue from collaboration agreements decreased from €120.1 million for the six months ended June 30, 2022 to €32.2 million for the six months ended June 30, 2023. The decrease in revenue of €87.9 million is mainly due to the recognized revenue regarding the right-to-use license for IMA401 amounting to €91.3 million for the six months ended June 30, 2022, partially offset by revenue recognized regarding the BMS Opt-in payment of €13.7 million for the six months ended June 30, 2023. The revenue for the six months ended June 30, 2023 from the collaboration agreement with Genmab decreased in comparison to the revenue for the three months ended June 30, 2023, due to the negative revenue for the three months ended March 31, 2023, 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. The collaboration with GSK was terminated in 2022, so no further revenue was recognized for the three and six months ended June 30, 2023.
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, |
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| 2023 | 2022 | 2023 | 2022 | |||||||||||||
| (Euros in thousands) | ||||||||||||||||
| Direct external research and development expenses by program: |
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| ACT Programs |
(5,204 | ) | (3,910 | ) | (8,803 | ) | (8,667 | ) | ||||||||
| TCR Bispecifics Programs |
(1,274 | ) | (1,028 | ) | (3,590 | ) | (2,090 | ) | ||||||||
| Other programs |
(1,441 | ) | (2,010 | ) | (3,032 | ) | (3,232 | ) | ||||||||
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| Sub-total direct external expenses |
(7,919 | ) | (6,947 | ) | (15,425 | ) | (13,990 | ) | ||||||||
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| Indirect research and development expenses: |
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| Personnel related (excluding share-based compensation) |
(9,973 | ) | (9,265 | ) | (19,882 | ) | (18,244 | ) | ||||||||
| Share-based compensation expenses |
(3,282 | ) | (3,107 | ) | (6,815 | ) | (6,375 | ) | ||||||||
| IP Expenses |
(2,213 | ) | (2,051 | ) | (4,563 | ) | (4,364 | ) | ||||||||
| Facility and depreciation |
(1,956 | ) | (1,718 | ) | (3,732 | ) | (3,414 | ) | ||||||||
| Other indirect costs |
(1,974 | ) | (2,128 | ) | (4,481 | ) | (3,974 | ) | ||||||||
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| Sub-total indirect expenses |
(19,398 | ) | (18,268 | ) | (39,473 | ) | (36,371 | ) | ||||||||
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| Total |
(27,317 | ) | (25,216 | ) | (54,898 | ) | (50,360 | ) | ||||||||
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Direct external research and development expenses for our ACT programs increased from €3.9 million for the three months ended June 30, 2022 to €5.2 million for the three months ended June 30, 2023. This increase mainly resulted from increased activities in our clinical trials during the second quarter of 2023, which was triggered in part by an increased number of patients recruited. Direct external research and development expenses for our TCR Bispecifics programs increased from €1.0 million for the three months ended June 30, 2022 to €1.3 million for the three months ended June 30, 2023. This increase mainly resulted from additional activities in our preclinical studies for IMA402 for which we applied for clinical trial approval in April 2023 and are preparing the start of the clinical trial.
Direct external research and development expenses for our other programs such as technology platforms and collaboration agreements decreased from €2.0 million for the three months ended June 30, 2022 to €1.4 million for the three months ended June 30, 2023. This decrease mainly resulted from collaboration timeline extensions which resulted in cost shifts as well as the termination of the GSK collaboration which was effective in the fourth quarter of 2022.
Direct external research and development expenses for our ACT programs increased from €8.7 million for the six months ended June 30, 2022 to €8.8 million for the six months ended June 30, 2023. This increase mainly resulted from increased activities in our clinical trials. Direct external research and development expenses for our TCR Bispecifics programs increased from €2.1 million for the six months ended June 30, 2022 to €3.6 million for the six months ended June 30, 2023. This increase mainly resulted from additional activities in our preclinical studies for IMA402 for which we applied for clinical trial approval in April 2023.
Direct external research and development expenses for our other programs such as technology platforms and collaboration agreements decreased from €3.2 million for the six months ended June 30, 2022 to €3.0 million for the six months ended June 30, 2023. This decrease mainly resulted from collaboration timeline extensions which resulted in cost shifts as well as the termination of the GSK collaboration which was effective in the fourth quarter of 2022.
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 €9.3 million for the three months ended June 30, 2022 to €10.0 million for the three months ended June 30, 2023. This increase resulted from our headcount growth due to our increased research and development activities including clinical trials. Share-based compensation expenses increased from €3.1 million for the three months ended June 30, 2022 to €3.3 million for the three months ended June 30, 2023. IP expenses increased from €2.1 million for the three months ended June 30, 2022 to €2.2 million for the three months ended June 30, 2023 due to our ongoing expansion of our IP portfolio. Facility and depreciation expenses increased from €1.7 million for the three months ended June 30, 2022 to €2.0 million for the three months ended June 30, 2023. This increase resulted from the acquisition of laboratory equipment and leasehold improvements. Other indirect expenses decreased from €2.1 million for the three months ended June 30, 2022 to €2.0 million for the three months ended June 30, 2023.
Personnel-related expenses increased from €18.2 million for the six months ended June 30, 2022 to €19.9 million for the six months ended June 30, 2023. This increase resulted from our headcount growth due to our increased research and development activities including clinical trials. Share-based compensation expenses increased from €6.4 million for the six months ended June 30, 2022 to €6.8 million for the six months ended June 30, 2023. IP expenses increased from €4.4 million for the six months ended June 30, 2022 to €4.6 million for the six months ended June 30, 2023 due to our ongoing expansion of our IP portfolio. Facility and depreciation expenses increased from €3.4 million for the six months ended June 30, 2022 to €3.7 million for the six months ended June 30, 2023. This increase resulted from the acquisition of laboratory equipment and leasehold improvements. Other indirect expenses increased from €4.0 million for the six months ended June 30, 2022 to €4.5 million for the six months ended June 30, 2023.
General and Administrative Expenses
The following table summarizes our General and administrative expenses for the periods indicated:
| Three Months Ended June 30, |
Six Months Ended June 30, |
|||||||||||||||
| 2023 | 2022 | 2023 | 2022 | |||||||||||||
| (Euros in thousands) | ||||||||||||||||
| Share-based compensation expenses |
(2,231 | ) | (2,453 | ) | (4,800 | ) | (4,887 | ) | ||||||||
| Personnel related (excluding share-based compensation) |
(2,891 | ) | (2,626 | ) | (6,441 | ) | (5,240 | ) | ||||||||
| Professional and consulting fees |
(1,698 | ) | (1,789 | ) | (2,658 | ) | (3,079 | ) | ||||||||
| Other external general and administrative expenses |
(2,538 | ) | (1,816 | ) | (5,045 | ) | (4,759 | ) | ||||||||
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|
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| Total |
(9,358 | ) | (8,683 | ) | (18,944 | ) | (17,961 | ) | ||||||||
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General and administrative expenses increased from €8.7 million for the three months ended June 30, 2022 to €9.4 million for the three months ended June 30, 2023.
Share-based compensation expenses decreased from €2.5 million for the three months ended June 30, 2022 to €2.2 million for the three months ended June 30, 2023.
Personnel related general and administrative expenses, excluding share-based compensation, increased from €2.6 million for the three months ended June 30, 2022 to €2.9 million for the three months ended June 30, 2023. The increase mainly resulted from an increased headcount in our finance, IT, human resources and communications functions.
Professional and consulting fees decreased from €1.8 million for the three months ended June 30, 2022 to €1.7 million for the three months ended June 30, 2023. The decrease in professional and consulting fees resulted mainly from lower legal expenses and consulting expenses.
Other external expenses increased from €1.8 million for the three months ended June 30, 2022 to €2.5 million for the three months ended June 30, 2023. The increase in other expenses mainly resulted from increased other operating expenses.
General and administrative expenses increased from €18.0 million for the six months ended June 30, 2022 to €18.9 million for the six months ended June 30, 2023.
Share-based compensation expenses decreased from €4.9 million for the six months ended June 30, 2022 to €4.8 million for the six months ended June 30, 2023.
Personnel related general and administrative expenses, excluding share-based compensation, increased from €5.2 million for the six months ended June 30, 2022 to €6.4 million for the six months ended June 30, 2023. The increase mainly resulted from an increased headcount in our finance, IT, human resources and communications functions.
Professional and consulting fees decreased from €3.1 million for the six months ended June 30, 2022 to €2.7 million for the six months ended June 30, 2023. The decrease in professional and consulting fees resulted mainly from lower legal expenses and consulting expenses.
Other external expenses increased from €4.8 million for the six months ended June 30, 2022 to €5.0 million for the six months ended June 30, 2023. The increase in other expenses mainly resulted from increased other operating expenses.
Other Financial Income and Other Financial Expenses
Other financial income decreased from €7.0 million for the three months ended June 30, 2022 to €4.0 million for the three months ended June 30, 2023. The decrease mainly resulted from lower foreign exchange gains.
Other financial expenses increased from €0.4 million for the three months ended June 30, 2022 to €1.1 million for the three months ended June 30, 2023. The increase mainly resulted from higher foreign exchange losses.
Other financial income decreased from €8.8 million for the six months ended June 30, 2022 to €6.7 million for the six months ended June 30, 2023. The decrease mainly resulted from lower foreign exchange gains.
Other financial expenses increased from €1.5 million for the six months ended June 30, 2022 to €4.7 million for the six months ended June 30, 2023. The increase mainly resulted from higher foreign exchange losses.
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 €2.35 ($2.51) per warrant as of December 31, 2022 to €1.32 ($1.44) as of March 31, 2023 and increased to €3.15 ($3.42) as of June 30, 2023. The result is an increase in fair value of warrant liabilities of €13.1 million for the three months ended June 30, 2023 and an increase in fair value of warrant liabilities of €5.7 million for the six months ended June 30, 2023.
The fair value of the warrants decreased from €3.88 ($4.39) per warrant as of December 31, 2021 to €1.58 ($1.75) as of March 31, 2022 and increased to €1.96 ($2.04) 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.
Liquidity and Capital Resources
Sources of Liquidity
We have incurred losses since inception, with the exception of the year ended December 31, 2022. We have negative cash flows from operations for the six months ended June 30, 2023 and positive cash flows from operations for the six months ended June 30, 2022. As of June 30, 2023, we had an accumulated deficit of €544.7 million.
We have funded our operations primarily from public offerings and private placements of our ordinary shares, upfront payments from collaborations agreements, and the net proceeds generated from the ARYA Merger and PIPE Financing that closed on July 1, 2020 and our public offering in October 2022.
Cash and cash equivalents decreased from €148.5 million as of December 31, 2022 to €130.4 million as of June 30, 2023.
We received a €13.7 million Opt-in payment from our collaboration partner BMS during the three months ended June 30, 2023. We received €212.4 million in connection with the strategic collaboration agreements with BMS and €106.2 million from a public offering of 10,905,000 ordinary shares during the year ended December 31, 2022.
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. Additionally, in 2021, we 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 six months ended June 30, 2023, 3.7 million shares had been sold under the ATM agreement with SVB Securities LLC and collected a gross amount of €38.6 million ($41.8 million).
The Company closed a private placement transaction of 2,419,818 ordinary shares with a subscription price of $14.46 per ordinary share with BMS and received gross proceeds of approximately $35 million after the reporting period.
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 make capital expenditures in the near term related to the expansion of our laboratory spaces in Tübingen, Germany and our new GMP manufacturing facility in Houston metropolitan area, Texas and 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, short-term deposits and AAA rated bonds.
Cash Flows
The following table summarizes our cash flows for each period presented:
| Six Months Ended June 30, | ||||||||
| 2023 | 2022 | |||||||
| (Euros in thousands) | ||||||||
| Net cash provided by / (used in): |
||||||||
| Operating activities* |
(30,323 | ) | 155,773 | |||||
| Investing activities |
(20,555 | ) | (48,528 | ) | ||||
| Financing activities |
35,585 | 15,203 | ||||||
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| Total* |
(15,293 | ) | 122,448 | |||||
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| * | See Note 3 of the Notes to the Unaudited Condensed Consolidated Financial Statements of Immatics N.V. for details regarding the revision of prior period numbers as a result of a correction in presentation of net foreign exchange differences and effects of exchange rate changes on cash and cash equivalents |
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. During the six months ended June 30, 2022, our cash flow from operating activities was positive, as we received an upfront payment from our collaboration partner BMS under the BMS IMA401 collaboration agreement.
Our net cash outflow from operating activities for the six months ended June, 2023 was €30.3 million. This was comprised of a loss of €44.4 million, an increase in working capital of €8.3 million and other effects of €2.7 million related to accrued interest income, partly offset by non-cash expense of €5.7 million related to the change in fair value of the warrants, non-cash charges from equity settled share-based compensation expenses for employees of €11.6 million, depreciation and amortization charge of €3.7 million and net foreign exchange differences and expected credit losses of €4.1 million. The increase in working capital mainly resulted from a decrease in deferred revenue, accounts payable and other liabilities of €9.9 million, partly offset by a decrease in accounts receivable of €0.8 million and a decrease in other assets and prepayments of €0.8 million.
Our net cash inflow from operating activities for the six months ended June, 2022 was €155.8 million. This was comprised of a net profit of €71.7 million, a decrease in working capital of €90.9 million, non-cash charges from equity settled share-based compensation expenses for employees of €11.3 million and depreciation and amortization charge of €3.4 million, partly offset by a non-cash income of €13.7 million related to the change in fair value of the warrants and net foreign exchange differences and expected credit losses of €7.8 million. The decrease in working capital mainly resulted from an increase in deferred revenue, accounts payable and other liabilities of €98.1 million, partly offset by an increase in accounts receivable of €0.3 million and a decrease in other assets and prepayments of €6.9 million.
Investing Activities
Our net outflow of cash from investing activities for the six months ended June 30, 2023 was €20.6 million. This consisted primarily of cash paid in the amount of €170.3 million for short-term deposit investments that are classified as Other financial assets and held with financial institutions to finance the company, €15.2 million as payment for new equipment and intangible assets, partially offset by cash received from maturity of bonds and short-term deposits of €164.9 million.
Our net outflow of cash from investing activities for the six months ended June 30, 2022 was €48.5 million. This consisted primarily of cash paid in the amount of €59.2 million for bond investments that are classified as Other financial assets and held with financial institutions to finance the company, €2.0 million as payment for new equipment and intangible assets, partially offset by cash received from maturity of bonds of €12.7 million.
Financing Activities
During the six months ended June 30, 2023, net cash provided from financing activities amounted to €35.6 million. As of June 30, 2023, 3.7 million shares had been sold under the ATM agreement with SVB Securities LLC and resulted in net proceeds of €37.4 million. This was partially offset by the principal portion of payments in connection with lease contracts.
During the six months ended June 30, 2022, net cash provided from financing activities amounted to €15.2 million. As of June 30, 2022, 2.4 million shares had been sold under the ATM agreement with SVB Securities LLC and resulted in net proceeds of €16.6 million. This was partially offset 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 €544.7 million as of June 30, 2023. 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:
| 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; |
| 2. | time and cost to conduct IND- or CTA-enabling studies for our preclinical programs; |
| 3. | time and costs required to perform research and development to identify and characterize new product candidates from our research programs; |
| 4. | 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; |
| 5. | our ability to successfully commercialize our product candidates, if approved; |
| 6. | our ability to have clinical and commercial products successfully manufactured consistent with FDA, the EMA and comparable regulatory authorities’ regulations; |
| 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; |
| 8. | sales and marketing costs associated with commercializing our products, if approved, including the cost and timing of building our marketing and sales capabilities; |
| 9. | cost of building, staffing and validating our manufacturing processes, which may include capital expenditure; |
| 10. | terms and timing of our current and any potential future collaborations, licensing or other arrangements that we have established or may establish; |
| 11. | cash requirements of any future acquisitions or the development of other product candidates; |
| 12. | costs of operating as a public company; |
| 13. | time and cost necessary to respond to technological, regulatory, political and market developments; |
| 14. | costs of filing, prosecuting, defending and enforcing any patent claims and other IP rights; and |
| 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 Factors—Risks Related to Our Financial Position” in our Annual Report.
Critical Accounting Estimates
Our unaudited interim condensed consolidated financial statements for the three and six month-period ended June 30, 2023 and 2022, 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 in accordance with IFRS requires the use of estimates and assumptions, which 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 fiscal year.
The preparation of the consolidated financial statements for the fiscal year ended December 31, 2022 and the three and six months ended June 30, 2023 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 significant 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 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 three of our four 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 IMA-401 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.
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 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, 2022. 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, 2023 and 2022 had no material effect on the consolidated financial statements of the Group.
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, accounts receivables and bonds. 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, bonds 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 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, short-term deposits and bonds. Our cash and cash equivalents, bonds 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 €130.4 million as of June 30, 2023. Approximately 73% of our cash and cash equivalents were held in Germany, of which approximately 52% were denominated in Euros and 48% 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 €111.7 million and U.S. Dollars in the amount of €105.5 million as of June 30, 2023.
Market risk and currency risk of warrants
The Group’s activities expose it 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, the Group’s 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 €2.3 million with a corresponding effect in the equity as of June 30, 2023.
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. For example, in September 2020, we filed an opposition and in October 2020 we commenced a cancellation proceeding against Immunocore Limited which challenges its IMMTAX trademark in various jurisdictions. In November 2020, Immunocore Limited filed counterclaims against our registered trademark IMMATICS and IMTX. This matter has now been amicably resolved.
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 Second Quarter 2023
Financial Results and Business Update
| • | Phase 1/2 clinical trial initiated evaluating Immatics’ second next-generation half-life extended TCR Bispecific program, TCER® IMA402 targeting PRAME |
| • | ACTengine® IMA203 TCR-T monotherapy against PRAME showed 67% confirmed ORR in an interim clinical update on 11 heavily pre-treated patients in Phase 1b dose expansion Cohort A with median duration of response not reached at a median follow-up time of 8.5 months at data cut-off; next update in 4Q 2023 |
| • | Bristol Myers Squibb exercised first opt-in into 2019 cell therapy collaboration ($15 million option fee received) and made a $35 million equity investment |
| • | Cash and cash equivalents as well as other financial assets not including the recent equity investment by Bristol Myers Squibb amount to $377.7 million1 (€347.6) as of June 30, 2023; updated projected cash runway is late 2025 |
Tuebingen, Germany and Houston, TX, August 17, 2023 – 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 June 30, 2023.
“The interim clinical data update for IMA203 monotherapy demonstrated an encouraging initial objective response rate in a range of solid cancer indications including durable responses supporting fast-tracking IMA203 to patients, starting with high-need solid cancers such as checkpoint-refractory melanoma and uveal melanoma,” said Harpreet Singh, Ph.D., CEO and Co-Founder of Immatics. “Beyond our recent IMA203 updates, we are pleased to report that we closed the second quarter with a cash position funding operations into late 2025. With this revised runway, we anticipate reaching our most critical milestones including the initiation of registration-directed trials for IMA203, as well as delivering meaningful data to assess clinical proof of concept for both TCER® programs IMA401 and IMA402.”
| 1 | All amounts translated using the exchange rate published by the European Central Bank in effect as of June 30, 2023 (1 EUR = 1.0866 USD). |
| Immatics Press Release August 17, 2023 | 1 | 11 |
Second Quarter 2023 and Subsequent Company Progress
Adoptive Cell Therapy Programs
ACTengine® IMA203: ACTengine® IMA203 TCR-T against PRAME is currently being evaluated in an ongoing Phase 1b dose expansion trial.
| • | As per the latest data cut-off of April 4, 2023, ACTengine® IMA203 TCR-T monotherapy Cohort A showed a 67% confirmed objective response rate (cORR) in an interim clinical update announced on May 2, 2023. The data covered 11 heavily pre-treated patients; the median duration of response was not reached at a median follow-up time of 8.5 months. Patients were infused with IMA203 TCR-T cells at dose level (DL) 4 or DL5 with a mean total infused dose of 3.67x109 TCR-T cells (range 1.30-8.84x109 TCR-T cells). |
| • | Cohort A IMA203 monotherapy TCR-T treatment continues to show manageable tolerability with no high-grade CRS and no ICANS; all 11 patients experienced expected cytopenia (Grade 1-4) associated with lymphodepletion. 10 patients (91%) had a low to moderate (Grade 1-2) cytokine release syndrome (CRS), of which 5 patients (45%) had Grade 1, and 5 patients (45%) had Grade 2 CRS. |
| • | Objective responses were observed independent of tumor type including checkpoint-refractory and BRAF inhibitor-refractory cutaneous melanoma, platinum-resistant ovarian cancer, uveal melanoma, head and neck cancer and synovial sarcoma. Longest duration of responses were observed in cutaneous and uveal melanoma with ongoing responses at 6, 9 and 10 months post infusion at data cut-off. |
| • | IMA203 in combination with nivolumab (Cohort B) has been de-prioritized in the last-line setting. Such a combination is being considered for the front-line setting. |
| • | IMA203CD8 (Cohort C) is a next-generation monotherapy where IMA203 engineered T cells are co-transduced with a CD8αß co-receptor. IMA203CD8 is currently being explored in DL4a (up to 0.8x109 TCR-T cells/m2 BSA). |
| • | Next update on Immatics’ IMA203 Phase 1b cohorts, including the projected clinical development path for PRAME-targeted TCR-T monotherapy towards registration-directed trials is planned for 4Q 2023. Immatics’ IMA203 development strategy to realize the multi-cancer opportunity of targeting PRAME is based on two pillars aimed at: |
| 1. | maximizing speed to market in one to two last-line solid cancer types focusing on cutaneous melanoma, uveal melanoma and potentially other tumor types with high PRAME prevalence where clinical proof-of-concept has been demonstrated, and |
| 2. | broad development with expansion to other cancer types, such as ovarian cancer, uterine cancer, lung cancer, breast cancer, head and neck cancer and other tumor types having a broad patient reach. |
| Immatics Press Release August 17, 2023 | 2 | 11 |
TCR-T pipeline
| • | Earlier this year, Bristol Myers Squibb exercised its first option and entered into a global license agreement with Immatics for the most advanced TCR-T product candidate. As part of the agreement, Immatics received an option payment of $15 million and is eligible for up to $490 million in milestone payments in addition to tiered royalties on net sales of the product. |
TCR Bispecifics Programs
Immatics’ T cell engaging receptor (TCER®) candidates are next-generation, half-life extended TCR Bispecific molecules designed to maximize efficacy while minimizing toxicities in patients through Immatics’ proprietary format using a low-affinity T cell recruiter and a high-affinity TCR domain.
| • | TCER® IMA401 (MAGEA4/8) – Phase 1 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®). MAGEA4 and MAGEA8 are expressed in multiple solid cancers including lung cancer, head and neck cancer, melanoma, ovarian cancer, sarcoma and others. IMA401 is being developed in collaboration with Bristol Myers Squibb. |
| • | TCER® IMA402 (PRAME) – Immatics submitted a clinical trial application (CTA2) to the Paul-Ehrlich-Institute (PEI) in April 2023. Following CTA acceptance, Immatics initiated the Phase 1/2 trial investigating the company’s fully owned TCER® candidate IMA402 in patients with recurrent and/or refractory solid tumors in August. Initial focus indications are cutaneous and uveal melanoma, ovarian cancer, lung cancer, uterine cancer and synovial sarcoma, among others. A first clinical data update is planned for 2024. 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®). |
| 2 | Clinical Trial Application (CTA) is the European equivalent of an Investigational New Drug (IND) application. |
| Immatics Press Release August 17, 2023 | 3 | 11 |
Corporate Updates
| • | On July 24, 2023, Bristol Myers Squibb purchased 2,419,818 ordinary shares in a private placement transaction at a subscription price per share of $14.463. Additionally, Bristol Myers Squibb will appoint a member to the Immatics Scientific Advisory Board. |
Second Quarter 2023 Financial Results
Equity: The Company raised a total of $64 million in June through August through its ATM facility.
Cash Position: Cash and cash equivalents as well as other financial assets total €347.6 million ($377.7 million1) as of June 30, 2023, compared to €362.2 million ($393.6 million1) as of December 31, 2022. The decrease is mainly due to our ongoing research and development activities, partially offset by the option fee received by Bristol Myers Squibb and funds raised in the period. The Company projects an updated cash runway into late 2025.
Revenue: Total revenue, consisting of revenue from collaboration agreements, was €22.4 million ($24.3 million1) for the three months ended June 30, 2023, compared to €17.2 million ($18.7 million1) for the three months ended June 30, 2022. The increase is mainly related to the recognition of revenue for the opt-in agreement with Bristol Myers Squibb signed during the three months ended June 30, 2023.
Research and Development Expenses: R&D expenses were €27.3&