Exhibit Number |
Description | |
99.1 |
||
99.2 |
||
101.INS |
XBRL Taxonomy Extension Instance Document | |
101.SCH |
XBRL Taxonomy Extension Schema Document | |
101.CAL |
XBRL Taxonomy Extension Calculation Linkbase Document | |
101.DEF |
XBRL Taxonomy Extension Definition Linkbase Document | |
101.LAB |
XBRL Taxonomy Extension Label Linkbase Document | |
101.PRE |
XBRL Taxonomy Extension Presentation Linkbase Document | |
| 104 | Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101). | |
IMMATICS N.V. | ||||||
| Date: August 13, 2024 | by: | /s/ Harpreet Singh | ||||
| Harpreet Singh | ||||||
| Chief Executive Officer | ||||||
Three months ended June 30, |
Six months ended June 30, |
|||||||||||||||||||
Notes |
2024 |
2023 |
2024 |
2023 |
||||||||||||||||
(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 |
( |
) |
( |
) | ||||||||||||||||
Loss before taxes |
( |
) |
( |
) |
( |
) |
( |
) | ||||||||||||
Taxes on income |
7 | ( |
) | ( |
) | |||||||||||||||
Net loss |
( |
) |
( |
) |
( |
) |
( |
) | ||||||||||||
Net loss per share: |
17 | |||||||||||||||||||
Basic |
( |
) | ( |
) | ( |
) | ( |
) | ||||||||||||
Diluted |
( |
) | ( |
) | ( |
) | ( |
) | ||||||||||||
Three months ended June 30, |
Six months ended June 30, |
|||||||||||||||||||
Notes |
2024 |
2023 |
2024 |
2023 |
||||||||||||||||
(Euros in thousands) |
(Euros in thousands) |
|||||||||||||||||||
Net loss |
( |
) |
( |
) |
( |
) |
( |
) | ||||||||||||
Other comprehensive income |
||||||||||||||||||||
Items that may be reclassified subsequently to profit or loss |
||||||||||||||||||||
Currency translation differences from foreign operations |
( |
) | ||||||||||||||||||
Total comprehensive loss for the year |
( |
) |
( |
) |
( |
) |
( |
) | ||||||||||||
As of |
||||||||||||
Notes |
June 30, 2024 |
December 31, 2023 |
||||||||||
(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, |
||||||||
2024 |
2023 |
|||||||
(Euros in thousands) |
||||||||
Cash flows from operating activities |
||||||||
Net loss |
( |
) | ( |
) | ||||
Taxes on income |
||||||||
Loss before tax |
( |
) |
( |
) | ||||
Adjustments for: |
||||||||
Interest income |
( |
) | ( |
) | ||||
Depreciation and amortization |
||||||||
Interest expenses |
||||||||
Equity-settled share-based payment |
||||||||
Loss from disposal of fixed assets |
||||||||
Net foreign exchange differences and expected credit losses |
( |
) | ||||||
Change in fair value of liabilities for warrants |
( |
) | ||||||
Changes in: |
||||||||
Decrease in accounts receivables |
||||||||
Decrease/(increase) in other assets |
( |
) | ||||||
(Decrease) in deferred revenue, accounts payables and other liabilities |
( |
) | ( |
) | ||||
Interest received |
||||||||
Interest paid |
( |
) | ( |
) | ||||
Income tax paid |
||||||||
Net cash used in operating activities |
( |
) |
( |
) | ||||
Cash flows from investing activities |
||||||||
Payments for property, plant and equipment |
( |
) | ( |
) | ||||
Payments for intangible assets |
( |
) | ( |
) | ||||
Payments for investments classified in other financial assets |
( |
) | ( |
) | ||||
Proceeds from maturity of investments classified in other financial assets |
||||||||
Net cash used in investing activities |
( |
) |
( |
) | ||||
Cash flows from financing activities |
||||||||
Proceeds from issuance of shares to equity holders |
||||||||
Transaction costs deducted from equity |
( |
) | ||||||
Repayments related to lease liabilities |
( |
) | ( |
) | ||||
Net cash provided by financing activities |
||||||||
Net decrease 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, 2023 |
( |
) |
( |
) |
||||||||||||||||||||
Other comprehensive income |
— | — | — | |||||||||||||||||||||
Net loss |
— | — | ( |
) | — | ( |
) | |||||||||||||||||
Comprehensive loss for the year |
— |
— |
( |
) |
( |
) | ||||||||||||||||||
Equity-settled share-based compensation |
8 | — | — | — | ||||||||||||||||||||
Share options exercised |
14 | — | — | — | ||||||||||||||||||||
Issue of share capital – net of transaction costs |
14 | — | — | |||||||||||||||||||||
Balance as of June 30, 2023 |
( |
) |
( |
) |
||||||||||||||||||||
Balance as of January 1, 2024 |
( |
) |
( |
) |
||||||||||||||||||||
Other comprehensive income |
— | — | — | |||||||||||||||||||||
Net loss |
— | — | ( |
) | — | ( |
) | |||||||||||||||||
Comprehensive loss for the year |
— |
— |
( |
) |
( |
) | ||||||||||||||||||
Equity-settled share-based compensation |
8 | — | — | — | ||||||||||||||||||||
Share options exercised |
14 | — | — | |||||||||||||||||||||
Issue of share capital – net of transaction costs |
14 | — | — | |||||||||||||||||||||
Balance as of June 30, 2024 |
( |
) |
( |
) |
||||||||||||||||||||
Three months ended June 30, |
Six months ended June 30, |
|||||||||||||||
2024 |
2023 |
2024 |
2023 |
|||||||||||||
(Euros in thousands) |
(Euros in thousands) |
|||||||||||||||
BMS, United States |
||||||||||||||||
Moderna, United States |
||||||||||||||||
Genmab, Denmark |
||||||||||||||||
Total |
||||||||||||||||
As of |
||||||||
June 30, 2024 |
December 31, 2023 |
|||||||
(Euros in thousands) |
||||||||
Current |
||||||||
Non-current |
||||||||
Total |
||||||||
Three months ended June 30, |
Six months ended June 30, |
|||||||||||||||
2024 |
2023 |
2024 |
2023 |
|||||||||||||
(Euros in thousands) |
(Euros in thousands) |
|||||||||||||||
Change in fair value of liabilities for warrants |
( |
) |
( |
) |
( |
) | ||||||||||
Interest income |
||||||||||||||||
Foreign currency gains |
||||||||||||||||
Gain on other financial instruments |
||||||||||||||||
Other financial income |
||||||||||||||||
Interest expenses |
( |
) | ( |
) | ( |
) | ( |
) | ||||||||
Foreign currency losses |
( |
) | ( |
) | ( |
) | ( |
) | ||||||||
Losses on financial instruments |
( |
) | ( |
) | ||||||||||||
Other financial expenses |
( |
) |
( |
) |
( |
) |
( |
) | ||||||||
Financial result |
( |
) |
( |
) | ||||||||||||
2024 |
||||||||
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) |
||||||||
2024 |
||||||||
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 February 7, 2024 |
As of March 6, 2024 |
As of June 25, 2024 |
||||||||||
Exercise price in USD |
$ | $ | $ | |||||||||
Underlying share price in USD |
$ | $ | $ | |||||||||
Volatility |
% | % | % | |||||||||
Time period (years) |
||||||||||||
Risk free rate |
% | % | % | |||||||||
Dividend yield |
% | % | % | |||||||||
2024 |
||||||||
Weighted average exercise price in USD |
Number |
|||||||
Service Options outstanding on January 1 |
||||||||
Service Options granted in 2024 |
||||||||
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) |
||||||||
As of February 7, 2024 |
||||
Exercise price in USD |
$ | |||
Underlying share price in USD |
$ | |||
Volatility |
% | |||
Time period (years) |
||||
Risk-free rate |
% | |||
Dividend yield |
% | |||
2024 |
||||||||
Weighted average exercise price in USD |
Number |
|||||||
PSUs outstanding on January 1 |
||||||||
PSUs granted in 2024 |
||||||||
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, |
|||||||||||||||
2024 |
2023 |
2024 |
2023 |
|||||||||||||
(Euros in thousands) |
(Euros in thousands) |
|||||||||||||||
Research and development expenses |
( |
) | ( |
) | ( |
) | ( |
) | ||||||||
General and administrative expenses |
( |
) | ( |
) | ( |
) | ( |
) | ||||||||
Total |
( |
) |
( |
) |
( |
) |
( |
) | ||||||||
As of |
||||||||
June 30, 2024 |
December 31, 2023 |
|||||||
(Euros in thousands) |
||||||||
Prepaid expenses |
||||||||
Value added tax receivables |
||||||||
Other assets |
||||||||
Total |
||||||||
As of |
||||||||
June 30, 2024 |
December 31, 2023 |
|||||||
(Euros in thousands) |
||||||||
Prepaid expenses |
||||||||
Other assets |
||||||||
Total |
||||||||
As of |
||||||||
June 30, 2024 |
December 31, 2023 |
|||||||
(Euros in thousands) |
||||||||
Provision for bonuses |
||||||||
Total |
||||||||
As of |
||||||||
June 30, 2024 |
December 31, 2023 |
|||||||
(Euros in thousands) |
||||||||
Accounts payables |
||||||||
Accrued liabilities |
||||||||
Total |
||||||||
As of |
||||||||
June 30, 2024 |
December 31, 2023 |
|||||||
(Euros in thousands) |
||||||||
Income tax liability |
||||||||
Accrual for vacation and overtime |
||||||||
Payroll tax |
||||||||
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 |
IFRS 16 |
June 30, 2024 |
||||||||||||||||||
Current/non-current assets |
||||||||||||||||||||||||
Cash and cash equivalents |
— | — | — | — | ||||||||||||||||||||
Short-term deposits* |
— | — | — | — | ||||||||||||||||||||
Accounts receivables |
— | — | — | — | ||||||||||||||||||||
Other current/non-current assets* |
— | — | — | — | ||||||||||||||||||||
Current/non-current liabilities |
||||||||||||||||||||||||
Accounts payables |
— | — | — | — | ||||||||||||||||||||
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 |
IFRS 16 |
December 31, 2023 |
||||||||||||||||||
Current/non-current assets |
||||||||||||||||||||||||
Cash and cash equivalents |
— | — | — | — | ||||||||||||||||||||
Short-term deposits* |
— | — | — | — | ||||||||||||||||||||
Accounts receivables |
— | — | — | — | ||||||||||||||||||||
Other current/non-current assets* |
— | — | — | — | ||||||||||||||||||||
Current/non-current liabilities |
||||||||||||||||||||||||
Accounts payables |
— | — | — | — | ||||||||||||||||||||
Other current liabilities |
— | — | — | — | ||||||||||||||||||||
Liabilities for warrants |
— | — | — | — | ||||||||||||||||||||
Lease liabilities |
— | — | — | |||||||||||||||||||||
Total |
— | |||||||||||||||||||||||
| * | “Short-term deposits” are classified within the balance sheet item “Other financial assets”. Other current/non-current assets comprise mainly of accrued interest and deposits. |
Three months ended June 30, |
Six months ended June 30, |
|||||||||||||||
2024 |
2023 |
2024 |
2023 |
|||||||||||||
(Euros in thousands, except share and per share data) |
(Euros in thousands, except share and per share data) |
|||||||||||||||
Net 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, 2024 and 2023 included in this interim report. You should also read our operating and financial review and prospects and our Consolidated Financial Statements for fiscal year 2023, and the notes thereto, in our Annual Report on Form 20-F for the year ended December 31, 2023, filed with the SEC on March 21, 2024 (the “Annual Report”). The following discussion is based on the financial information of Immatics prepared in accordance with International Financial Reporting Standards (“IFRS”), which may differ in material respects from generally accepted accounting principles in other jurisdictions, including U.S. generally accepted accounting principles.
Overview
We are a clinical-stage biotechnology company dedicated to the development of T cell receptor (“TCR”)-based immunotherapies for the treatment of cancer. Our purpose is to deliver a meaningful impact on the lives of cancer patients by developing novel TCR-based immunotherapies that are designed to achieve effect beyond an incremental clinical benefit. Our focus is the development of product candidates for the treatment of patients with solid tumors, who are inadequately served by existing treatment modalities. We strive to become an industry leading, fully integrated global biopharmaceutical company engaged in developing, manufacturing and commercializing TCR immunotherapies for the benefit of cancer patients, our employees, our shareholders and our partners.
By utilizing TCR-based therapeutics, we are able to direct T cells to intracellular cancer targets that are not accessible through classical antibody-based or CAR-T therapies. We believe that by identifying what we call true cancer targets and the right TCRs, we are well positioned to transform current solid tumor treatment paradigms by delivering cellular and bispecific product candidates that have the potential to substantially improve the lives of cancer patients.
We are developing our targeted immunotherapy product candidates through two distinct treatment modalities: TCR-engineered autologous (“ACTengine”) or allogeneic (“ACTallo”) Adoptive Cell Therapies (“ACT”) and antibody-like Bispecifics, also called T cell Engaging Receptors (“TCER”). Each modality is designed with distinct attributes and mechanisms of action to produce the desired therapeutic effect for multiple cancer patient populations with different unmet medical needs. Our current pipeline comprises several proprietary TCR-based product candidates in clinical and preclinical development. In addition to our proprietary pipeline, we are collaborating with industry-leading partners, including Bristol Myers Squibb (“BMS”), Moderna and Editas Medicine, to develop multiple additional therapeutic programs covering ACT and Bispecifics. In September 2023, we entered into a collaboration with Moderna, which became effective on October 12, 2023. On March 14, 2024, Genmab provided us with a termination notice relating to our collaboration, originally announced in July 2018.
Since our inception, we have focused on developing our technologies and executing our preclinical and clinical research programs with the aim to deliver the power of T cells to cancer patients. We do not have any products approved for sale. We have funded our operations primarily through equity financing and through payments from our collaboration partners.
We have assembled a team of 542 and 482 FTEs as of June 30, 2024 and December 31, 2023, respectively.
Through June 30, 2024 we have raised €1.32 billion through licensing payments from our collaborators and through private and public placements of securities. This includes the net proceeds of €173 million received in January 2024 from our public offering. We are holding Cash and cash equivalents and Other financial assets of €531.1 million as of June 30, 2024. We believe that we have sufficient capital resources to fund our operations through at least the next 12 months.
Since our inception, we have incurred net losses, which have been significant in recent periods. The net profit for the year ended December 31, 2022 was due to a one-time upfront payment. We expect to continue to incur significant expenses and increasing net losses for the foreseeable future as we continue our research and development efforts and seek to obtain regulatory approval for and commercialize our product candidates. Our future profitability will be dependent upon the successful development, approval and commercialization of our product candidates and achieving a level of revenues adequate to support our cost structure. We may never achieve profitability and, unless and until we do, we will continue to need to raise additional capital. Our net losses may fluctuate significantly from period to period and year to year.
Global Developments
Currently, multiple global uncertainties are existing.
The conflicts between Russia and Ukraine and the Palestinian-Israeli conflict have resulted, and may further result, in significant disruption, instability and volatility in global markets, as well as higher energy and other commodity prices. Since the Company is not currently conducting any business or receiving any material services from vendors located in Russia, Ukraine or Israel, it does not expect that the ongoing conflicts will have a direct impact on its operations in the near term. However, the Company may be indirectly affected by price increases or certain policy changes, such as new tax legislation, economic sanctions and comparable measures. While the conflicts are currently not expected to have a direct impact on our Company, this may change especially in case of further expansion of the scale of the conflicts. In addition, other geopolitical instabilities might impact the Group in the future.
Our Strategy
Our mission is to deliver the power of T cells to cancer patients. We seek to execute the following strategy to develop TCR-based immunotherapies for the treatment of cancer, maximizing the value of our technology platforms and the broad portfolio of product candidates:
| • | Advance IMA203 to FDA approval and commercialization. We plan to commence a registration-enabling randomized Phase 2/3 trial for ACTengine IMA203 in second-line or later (2L+) melanoma in 2024. At the same time, we are continuing dose escalation of IMA203CD8 (GEN2) with the goal of defining the optimal dose for further development. The next data update for IMA203CD8 (GEN2) is planned for 2H 2024 with a focus on continued dose escalation data in melanoma patients. In addition to treating melanoma patients, we have also started to expand our clinical footprint outside of melanoma to address a broader patient population with a particular focus on ovarian and uterine cancers. |
| • | Further enhance our cell therapy manufacturing capabilities. Our late-stage clinical cell therapy development is supported by our manufacturing process, timeline, capabilities and facility. IMA203 and IMA203CD8 (GEN2) cell therapy products are manufactured within 7 days followed by a 7-day QC release testing at a success rate of >95% to reach the target dose. We have also completed construction of a ~100,000 square foot R&D and GMP manufacturing facility with a modular design for efficient and cost-effective scalability to serve early-stage and registration-enabling clinical trials, as well as potential initial commercial supply. The new site will start GMP manufacturing of cell therapy products in early 2025. Meanwhile, the existing GMP facility, which is run in collaboration with UT Health, will remain active until YE 2025 and will also initially serve the Phase 2/3 registrational trial. |
| • | Deliver clinical PoC for our next-generation, half-life extended TCR Bispecifics (TCERs) and further clinical development. We seek to deliver clinical PoC for our novel TCER platform as fast as possible and plan to provide first clinical data for our two TCER lead candidates (IMA401 targeting MAGEA4/8 and IMA402 targeting PRAME) in 2H 2024. Specifically, the first clinical data on IMA401 will be presented at the European Society for Medical Oncology (ESMO) Congress 2024. Key objectives are (1) to demonstrate the tolerability of our novel next-generation, half-life extended TCR Bispecifics format, (2) to optimize dosing schedule to a less frequent regimen already during dose escalation based on pharmacokinetic data and (3) to demonstrate initial clinical anti-tumor activity. IMA402 data will be announced later in 2H 2024. |
| • | Advance our preclinical pipeline of next-generation, half-life extended TCR Bispecifics. We continue the development of several innovative preclinical TCER product candidates against so far undisclosed targets for our proprietary and/or partnered pipeline. Our next-generation, half-life extended TCER format used in all our candidates is designed to safely apply high drug doses for activity in a broad range of tumors, even with low target density, and to achieve a patient-convenient dosing schedule. |
| • | Advance our preclinical pipeline of innovative ACTengine candidates. Our pipeline is strengthened by innovative cell therapy programs in development, such as ACTengine IMA204, directed against the novel tumor stroma target COL6A3. We believe IMA204 provides a promising and innovative therapeutic opportunity for a broad patient population as a monotherapy or in combination with TCR-T cells directed against tumor targets. |
| • | Further enhance our cell therapy platform including the development of allogeneic off-the-shelf cell therapies. We continue to actively investigate next-generation enhancement and combination strategies to render ACTengine T cells even more potent to combat solid tumors, enhance tolerability and further boost the usability of our product candidates. Furthermore, we aim to expedite the supply of cell therapy products to patients and lower costs with our off-the-shelf cell therapy approach, ACTallo. |
| • | Leverage the full potential of strategic collaborations. We have entered strategic collaborations with key industry partners to maintain our leadership position in the TCR therapeutics field and are also actively seeking to enter further strategic collaborations with industry-leading partners to strengthen our proprietary pipeline. We intend to generate value from these strategic collaborations by developing transformative, cutting-edge therapeutics through the combination of synergistic capabilities and technologies, and we benefit from upfront payments, potential milestone payments and royalties for product candidates that our partners successfully advance into and through clinical development and towards commercial launch. |
| • | Enhance the competitive edge of our technology platforms. Our target and TCR discovery platforms, XPRESIDENT, XCEPTOR and XCUBE are the foundation for the further strengthening of our product pipeline and our position in the field of TCR-based therapies. Our goal is to maintain and expand our competitive edge with these proprietary and differentiated platform technologies. |
| • | Strengthen our intellectual property portfolio. We intend to continuously build and maintain our intellectual property portfolio to successfully defend and strengthen our position in the field of TCR therapies. |
Components of Operating Results
Revenue from Collaboration Agreements
To date, we have not generated any revenue from the sale of pharmaceutical products. Our revenue has been solely derived from our collaboration agreements, such as with BMS, Genmab and Moderna. Our revenue from collaboration agreements consists of upfront payments as well as reimbursement of research and development expenses.
Upfront payments allocated to the obligation to perform research and development services are initially recorded on our statement of financial position as deferred revenue and are subsequently recognized as revenue on a cost-to-cost measurement basis, in accordance with our accounting policy as described further under “Critical Accounting Estimates.”
As part of the collaboration arrangements, we grant exclusive licensing rights for the development and commercialization of future product candidates, developed for specified targets defined in the respective collaboration agreement. We carry out our research activities using our proprietary technology and know-how, participate in joint steering committees, and prepare data packages. In two of our four current revenue generating collaboration agreements, these commitments represent one combined performance obligation, because the research activities are mutually dependent and the collaborator is unable to derive significant benefit from our access to these targets without our research activities, which are highly specialized and cannot be performed by other organizations. For the collaboration signed with BMS in December 2021, we identified two separate performance obligations, because the license is a distinct obligation and the clinical trial services will not result in a modification of the license. For the collaboration signed with Moderna in September 2023, the Group identified the following distinct performance obligations: initial early pre-clinical targets from the TCER part (“Early TCER Activities”), one initial advanced pre-clinical target from the TCER part (“Advanced TCER Activities”) and four distinct performance obligations which, due to their identical accounting treatment as license accesses, are jointly accounted for as one performance obligation (“Database Activities”).
All collaboration agreements resulted in a total of €525.7 million of upfront payments through June 30, 2024. We received €113.0 million ($120.0 million) in connection with the strategic collaboration agreement with Moderna and a €13.7 million ($15.0 million) Opt-in payment from our collaboration partner BMS in 2023. As part of the agreements, we contribute insights from XPRESIDENT and other technologies, as well as commit to participating in joint research activities. In addition, we agree to license certain target rights and the potential product candidates developed under the collaboration.
Under each of our revenue generating collaboration agreements, we are entitled to receive payments for certain development and commercial milestone events, in addition to royalty payments upon successful commercialization of a product. The uncertainty of achieving these milestones significantly impacts our ability to generate revenue.
Our ability to generate revenue from sales of pharmaceutical products and to become profitable depends on the successful commercialization of product candidates by us and/or by our collaboration partners. In the foreseeable future, we do not expect revenue from product sales. To the extent that existing or potential future collaborations generate revenue, our revenue may vary due to many uncertainties in the development of our product candidates and other factors.
Research and Development Expenses
Research and development expenses consist primarily of personnel-related costs (including share-based compensation) for the various research and development departments, intellectual property (“IP”) expenses, facility-related costs and amortization as well as direct expenses for clinical and preclinical programs.
Our core business is focused on the following initiatives with the goal of providing novel TCR-based immunotherapies to cancer patients:
| • | Advance IMA203 to FDA approval and commercialization; |
| • | Further enhance our cell therapy manufacturing capabilities; |
| • | Deliver clinical PoC for our next-generation, half-life extended TCR Bispecifics (TCERs) and further clinical development; |
| • | Advance our preclinical pipeline of next-generation, half-life extended TCR Bispecifics; |
| • | Advance our preclinical pipeline of innovative ACTengine candidates; |
| • | Further enhance our cell therapy platform including development of allogeneic off-the-shelf cell therapies; |
| • | Leverage the full potential of strategic collaborations; |
| • | Enhance the competitive edge of our technology platforms; and |
| • | Strengthen our intellectual property portfolio. |
Research expenses are defined as costs incurred for current or planned investigations undertaken with the prospect of gaining new scientific or technical knowledge and understanding. All research and development costs are expensed as incurred due to scientific uncertainty.
We expect our research and development expenses to increase substantially in the future as we advance existing and future proprietary product candidates into and through clinical studies and pursue regulatory approval. The process of conducting the necessary clinical studies to obtain regulatory approval is costly and time-consuming. We expect to increase our headcount to support our continued research activities and to advance the development of our product candidates. Clinical studies generally become larger and more costly to conduct as they advance into later stages and, in the future, we will be required to make estimates for expense accruals related to clinical study expenses. At this time, we cannot reasonably estimate or know the nature, timing and estimated costs of the efforts that will be necessary to complete the development of any product candidates that we develop from our programs. We must demonstrate our products’ safety and efficacy through extensive clinical testing. We may experience numerous unforeseen events during, or as a result of, the testing process that could delay or prevent commercialization of our products, including but not limited to the following:
| • | after reviewing trial results, we or our collaborators may abandon projects previously believed to be promising; |
| • | we, our collaborators, or regulators may suspend or terminate clinical trials if the participating subjects or patients are being exposed to unacceptable health risks; |
| • | our potential products may not achieve the desired effects or may include undesirable side effects or other characteristics that preclude regulatory approval or limit their commercial use if approved; |
| • | contract manufacturing may not meet the necessary standards for the production of the product candidates or may not be able to supply the product candidates in a sufficient quantity; |
| • | regulatory authorities may find that our clinical trial design or conduct does not meet the applicable approval requirements; and |
| • | safety and efficacy results in various human clinical trials reported in scientific and medical literature may not be indicative of results we obtain in our clinical trials. |
Clinical testing is very expensive, can take many years, and the outcome is uncertain. The data collected from our clinical trials of our ACT or TCR Bispecifics candidates may not be sufficient to support approval by the FDA, the EMA or comparable regulatory authorities of our ACT or TCR Bispecific product candidates for the treatment of solid tumors. The clinical trials for our products under development may not be completed on schedule and the FDA, EMA or regulatory authorities in other countries may not ultimately approve any of our product candidates for commercial sale. If we fail to adequately demonstrate the safety and effectiveness of any product candidate under development, we may not receive regulatory approval for those product candidates, which would prevent us from generating revenues or achieving profitability.
General and Administrative Expenses
General and administrative expenses consist primarily of personnel-related costs (including share-based compensation) for finance, legal, human resources, business development and other administrative and operational functions, professional fees, accounting and legal services, information technology and facility-related costs. These costs relate to the operation of the business, unrelated to the research and development function or any individual program.
Due to our planned increase in research and development activities as explained above, we also expect that our general and administrative expenses might increase. We might incur increased accounting, audit, legal, regulatory, compliance, director and officer insurance costs. Additionally, if and when a regulatory approval of a product candidate appears likely, we anticipate an increase in payroll and expenses as a result of our preparation for commercial operations.
Financial Result
Financial result consists of income and expenses from changes in fair value of warrant liability as well as both other financial income and other financial expenses. Our warrants are classified as liabilities recorded at fair value through profit and loss. Other financial income results primarily from interest income and foreign exchange gains. Other financial expenses consist of interest expenses related to lease liabilities, foreign exchange losses and expected credit losses.
Results of Operations
Comparison of the Three and Six Months Ended June 30, 2024 and June 30, 2023
The following table summarizes our consolidated statements of operations for each period presented:
| Three months ended June 30, |
Six months ended June 30, |
|||||||||||||||
| 2024 | 2023 | 2024 | 2023 | |||||||||||||
| (Euros in thousands, except per share data) | (Euros in thousands, except per share data) | |||||||||||||||
| Revenue from collaboration agreements |
18,755 | 22,354 | 49,024 | 32,150 | ||||||||||||
| Research and development expenses |
(35,216 | ) | (27,317 | ) | (67,324 | ) | (54,898 | ) | ||||||||
| General and administrative expenses |
(10,128 | ) | (9,358 | ) | (21,770 | ) | (18,944 | ) | ||||||||
| Other income |
25 | 6 | 37 | 948 | ||||||||||||
|
|
|
|
|
|
|
|
|
|||||||||
| Operating result |
(26,564 | ) | (14,315 | ) | (40,033 | ) | (40,744 | ) | ||||||||
| Change in fair value of liabilities for warrants |
(648 | ) | (13,105 | ) | 395 | (5,708 | ) | |||||||||
| Other financial income |
9,665 | 3,954 | 20,580 | 6,748 | ||||||||||||
| Other financial expenses |
(305 | ) | (1,144 | ) | (515 | ) | (4,653 | ) | ||||||||
|
|
|
|
|
|
|
|
|
|||||||||
| Financial result |
8,712 | (10,295 | ) | 20,460 | (3,613 | ) | ||||||||||
|
|
|
|
|
|
|
|
|
|||||||||
| Loss before taxes |
(17,852 | ) | (24,610 | ) | (19,573 | ) | (44,357 | ) | ||||||||
| Taxes on income |
(170 | ) | — | (1,503 | ) | — | ||||||||||
| Net loss |
(18,022 | ) | (24,610 | ) | (21,076 | ) | (44,357 | ) | ||||||||
|
|
|
|
|
|
|
|
|
|||||||||
| Net loss per share: |
||||||||||||||||
| Basic |
(0.17 | ) | (0.32 | ) | (0.21 | ) | (0.58 | ) | ||||||||
| Diluted |
(0.17 | ) | (0.32 | ) | (0.21 | ) | (0.58 | ) | ||||||||
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, |
|||||||||||||||
| 2024 | 2023 | 2024 | 2023 | |||||||||||||
| (Euros in thousands) | (Euros in thousands) | |||||||||||||||
| BMS, United States |
10,035 | 21,439 | 15,770 | 31,935 | ||||||||||||
| Moderna, United States |
8,720 | — | 18,303 | — | ||||||||||||
| Genmab, Denmark |
— | 915 | 14,951 | 215 | ||||||||||||
|
|
|
|
|
|
|
|
|
|||||||||
| Total |
18,755 | 22,354 | 49,024 | 32,150 | ||||||||||||
|
|
|
|
|
|
|
|
|
|||||||||
Our revenue from collaboration agreements decreased from €22.4 million for the three months ended June 30, 2023 to €18.8 million for the three months ended June 30, 2024. The decrease in revenue of €3.6 million is mainly due to an Opt-in payment of €13.7 million by BMS for the three months ended June 30, 2023 compared to the three months ended June 30, 2024, partly offset by revenue recognized under the new collaboration with Moderna, which we entered into in October 2023 and which resulted in revenue of €8.7 million for the three months ended June 30, 2024.
Our Revenue from collaboration agreements increased from €32.2 million for the six months ended June 30, 2023 to €49.0 million for the six months ended June 30, 2024. The increase in revenue of €16.8 million is mainly due to the recognition of the remaining deferred revenue of the Genmab collaboration of €14.9 million as part of the termination of the collaboration as well as revenue from our new collaboration with Moderna, resulting in revenue of €18.3 million for the six months ended June 30, 2024. The increase was partially offset by an Opt-in payment of €13.7 million for the six months ended June 30, 2023 compared to the six months ended June 30, 2024.
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, |
|||||||||||||||
| 2024 | 2023 | 2024 | 2023 | |||||||||||||
| (Euros in thousands) | (Euros in thousands) | |||||||||||||||
| Direct external research and development expenses by program: |
||||||||||||||||
| ACT Programs |
(6,849 | ) | (5,204 | ) | (11,607 | ) | (8,803 | ) | ||||||||
| TCR Bispecifics Programs |
(2,461 | ) | (1,274 | ) | (4,318 | ) | (3,590 | ) | ||||||||
| Other programs |
(1,820 | ) | (1,441 | ) | (3,785 | ) | (3,032 | ) | ||||||||
|
|
|
|
|
|
|
|
|
|||||||||
| Sub-total direct external expenses |
(11,130 | ) | (7,919 | ) | (19,710 | ) | (15,425 | ) | ||||||||
|
|
|
|
|
|
|
|
|
|||||||||
| Indirect research and development expenses: |
||||||||||||||||
| Personnel related (excluding share-based compensation) |
(14,097 | ) | (9,973 | ) | (27,495 | ) | (19,882 | ) | ||||||||
| Share-based compensation expenses |
(2,595 | ) | (3,282 | ) | (4,863 | ) | (6,815 | ) | ||||||||
| IP Expenses |
(994 | ) | (2,213 | ) | (2,799 | ) | (4,563 | ) | ||||||||
| Facility and depreciation |
(2,889 | ) | (1,956 | ) | (5,418 | ) | (3,732 | ) | ||||||||
| Other indirect costs |
(3,511 | ) | (1,974 | ) | (7,039 | ) | (4,481 | ) | ||||||||
|
|
|
|
|
|
|
|
|
|||||||||
| Sub-total indirect expenses |
(24,086 | ) | (19,398 | ) | (47,614 | ) | (39,473 | ) | ||||||||
|
|
|
|
|
|
|
|
|
|||||||||
| Total |
(35,216 | ) | (27,317 | ) | (67,324 | ) | (54,898 | ) | ||||||||
|
|
|
|
|
|
|
|
|
|||||||||
Direct external research and development expenses for our ACT programs increased from €5.2 million for the three months ended June 30, 2023 to €6.8 million for the three months ended June 30, 2024. This increase mainly resulted from increased activities in our clinical trials for IMA203. Direct external research and development expenses for our TCR Bispecifics programs increased from €1.3 million for the three months ended June 30, 2023 to €2.5 million for the three months ended June 30, 2024. This increase mainly resulted from increased activities for IMA402.
Direct external research and development expenses for our other programs such as technology platforms and collaboration agreements increased from €1.4 million for the three months ended June 30, 2023 to €1.8 million for the three months ended June 30, 2024. This increase mainly resulted from higher activities for IMA401, which is being developed in a collaboration with BMS, as well as from increased activities from the Moderna collaboration.
Direct external research and development expenses for our ACT programs increased from €8.8 million for the six months ended June 30, 2023 to €11.6 million for the six months ended June 30, 2024. This increase mainly resulted from increased activities in our clinical trials for IMA203. Direct external research and development expenses for our TCR Bispecifics programs increased from €3.6 million for the six months ended June 30, 2023 to €4.3 million for the six months ended June 30, 2024. This increase mainly resulted from additional activities for IMA402.
Direct external research and development expenses for our other programs such as technology platforms and collaboration agreements increased from €3.0 million for the six months ended June 30, 2023 to €3.8 million for the six months ended June 30, 2024. This increase mainly resulted from increased activities for the BMS collaboration for IMA401 and the Moderna collaborations.
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 €10.0 million for the three months ended June 30, 2023 to €14.1 million for the three months ended June 30, 2024. This increase resulted from our headcount growth due to our increased research and development activities including clinical trials. Share-based compensation expenses decreased from €3.3 million for the three months ended June 30, 2023 to €2.6 million for the three months ended June 30, 2024. Shared-based compensation expenses decrease over time mainly
due to the fact that certain awards granted as part of the ARYA Merger have fully vested. IP expenses decreased from €2.2 million for the three months ended June 30, 2023 to €1.0 million for the three months ended June 30, 2024 and is in range of normal fluctuations. Facility and depreciation expenses increased from €2.0 million for the three months ended June 30, 2023 to €2.9 million for the three months ended June 30, 2024 due to start of depreciation of our GMP facility in Houston. Other indirect expenses increased from €2.0 million for the three months ended June 30, 2023 to €3.5 million for the three months ended June 30, 2024. This increase resulted from our expanded research and development activities.
Personnel-related expenses increased from €19.9 million for the six months ended June 30, 2023 to €27.5 million for the six months ended June 30, 2024. This increase resulted from our headcount growth due to our increased research and development activities including clinical trials. Share-based compensation expenses decreased from €6.8 million for the six months ended June 30, 2023 to €4.9 million for the six months ended June 30, 2024. Shared-based compensation expenses decrease over time mainly due to the fact that certain awards granted as part of the ARYA Merger have fully vested. IP expenses decreased from €4.6 million for the six months ended June 30, 2023 to €2.8 million for the six months ended June 30, 2024 and is in range with normal fluctuations. Facility and depreciation expenses increased from €3.7 million for the six months ended June 30, 2023 to €5.4 million for the six months ended June 30, 2024 due to start of depreciation of our GMP facility in Houston. Other indirect expenses increased from €4.5 million for the six months ended June 30, 2023 to €7.0 million for the six months ended June 30, 2024. This increase resulted from our expanded research and development activities.
General and Administrative Expenses
The following table summarizes our general and administrative expenses for the periods indicated:
| Three Months Ended June 30, |
Six Months Ended June 30, |
|||||||||||||||
| 2024 | 2023 | 2024 | 2023 | |||||||||||||
| (Euros in thousands) | (Euros in thousands) | |||||||||||||||
| Share-based compensation expenses |
(1,713 | ) | (2,231 | ) | (3,742 | ) | (4,800 | ) | ||||||||
| Personnel related (excluding share-based compensation) |
(3,909 | ) | (2,891 | ) | (7,703 | ) | (6,441 | ) | ||||||||
| Professional and consulting fees |
(1,225 | ) | (1,698 | ) | (3,303 | ) | (2,658 | ) | ||||||||
| Other external general and administrative expenses |
(3,281 | ) | (2,538 | ) | (7,022 | ) | (5,045 | ) | ||||||||
|
|
|
|
|
|
|
|
|
|||||||||
| Total |
(10,128 | ) | (9,358 | ) | (21,770 | ) | (18,944 | ) | ||||||||
|
|
|
|
|
|
|
|
|
|||||||||
General and administrative expenses increased from €9.4 million for the three months ended June 30, 2023 to €10.1 million for the three months ended June 30, 2024.
Share-based compensation expenses decreased from €2.2 million for the three months ended June 30, 2023 to €1.7 million for the three months ended June 30, 2024. Shared-based compensation expenses decrease over time mainly due to the fact that certain awards granted as part of the ARYA Merger have fully vested.
Personnel related general and administrative expenses, excluding share-based compensation, increased from €2.9 million for the three months ended June 30, 2023 to €3.9 million for the three months ended June 30, 2024. The increase mainly resulted from an increased headcount in our finance, IT, human resources and communications functions.
Professional and consulting fees decreased from €1.7 million for the three months ended June 30, 2023 to €1.2 million for the three months ended June 30, 2024. The decrease in professional and consulting fees resulted mainly from lower consulting expenses.
Other external expenses increased from €2.5 million for the three months ended June 30, 2023 to €3.3 million for the three months ended June 30, 2024. The increase in other expenses mainly resulted from increased insurance depreciation and facility expenses.
General and administrative expenses increased from €18.9 million for the six months ended June 30, 2023 to €21.8 million for the six months ended June 30, 2024.
Share-based compensation expenses decreased from €4.8 million for the six months ended June 30, 2023 to €3.7 million for the six months ended June 30, 2024. Shared-based compensation expenses decrease over time mainly due to the fact that certain awards granted as part of the ARYA Merger have fully vested.
Personnel related general and administrative expenses, excluding share-based compensation, increased from €6.4 million for the six months ended June 30, 2023 to €7.7 million for the six months ended June 30, 2024. The increase mainly resulted from an increased headcount in our finance, IT, human resources and communications functions.
Professional and consulting fees increased from €2.7 million for the six months ended June 30, 2023 to €3.3 million for the six months ended June 30, 2024. The increase in professional and consulting fees resulted mainly from higher consulting expenses.
Other external expenses increased from €5.0 million for the six months ended June 30, 2023 to €7.0 million for the six months ended June 30, 2024. The increase in other expenses mainly resulted from increased depreciation and facility expenses.
Change in fair value of warrant liabilities
Subsequent to the Business Combination, there were 7,187,500 warrants outstanding, which were classified as financial liabilities through profit and loss. The warrants entitle the holder to purchase one ordinary share at an exercise price of $11.50 per share. The warrants will expire five years after the completion of the Business Combination or earlier upon redemption or liquidation in accordance with their terms.
The fair value of the warrants decreased from €2.64 ($2.92) per warrant as of December 31, 2023 to €2.50 ($2.70) per warrant as of March 31, 2024 and increased to €2.59 ($2.77) as of June 30, 2024. The result is an increase in fair value of liabilities for warrants of €0.6 million and a corresponding expense for the three months ended June 30, 2024 and a decrease in fair value of liabilities for warrants of €0.4 million for the six months ended June 30, 2024
Other Financial Income and Other Financial Expenses
Other financial income increased from €4.0 million for the three months ended June 30, 2023 to €9.7 million for the three months ended June 30, 2024. The increase mainly resulted from interest income and unrealized foreign exchange gains.
Other financial expenses decreased from €1.1 million for the three months ended June 30, 2023 to €0.3 million for the three months ended June 30, 2024. The decrease mainly resulted from lower foreign exchange losses.
Other financial income increased from €6.7 million for the six months ended June 30, 2023 to €20.6 million for the six months ended June 30, 2024. The increase mainly resulted from higher interest income and higher foreign exchange gains.
Other financial expenses decreased from €4.7 million for the six months ended June 30, 2023 to €0.5 million for the six months ended June 30, 2024. The decrease mainly resulted from lower foreign exchange losses.
Taxes on income
Taxes on income increased from €0.0 million for the three months ended June 30, 2023 to €0.2 million for the three months ended June 30, 2024. The increase mainly resulted from a taxable profit of Immatics GmbH due to revenue recognized in conjunction with the collaboration agreements.
Taxes on income increased from €0.0 million for the six months ended June 30, 2023 to €1.5 million for the six months ended June 30, 2024. The increase mainly resulted from a taxable profit of Immatics GmbH due to revenue recognized in conjunction with the collaboration agreements and the termination of the Genmab collaboration.
Liquidity and Capital Resources
Cash and cash equivalents decreased from €218.5 million as of December 31, 2023 to €158.1 million as of June 30, 2024.
We believe our existing Cash, cash equivalents and Other financial assets will be sufficient to fund our operating expenses and capital expenditure requirements through at least the next 12 months. We may consider raising additional capital to pursue strategic investments, to take advantage of financing opportunities or for other reasons.
Sources and Uses of Liquidity
We have incurred losses since inception, with the exception of the year ended December 31, 2022. As of June 30, 2024, we had an accumulated deficit of €618.4 million.
We have funded our operations primarily from public offerings and private placements of our equity securities as well as upfront and other payments from collaboration agreements.
In January 2024, we received €173.4 million net proceeds (after deducting the underwriting discount, fees and offering expenses payable by the company), from an offering of 18,313,750 ordinary shares.
In the year ended December 31, 2023, we received (i) €113.0 million ($120.0 million) in connection with the strategic collaboration agreement with Moderna; (ii) a €13.7 million ($15.0 million) Opt-in payment from our collaboration partner BMS; and (iii) €31.5 million from a private placement of equity securities. Additionally, we have established an at-the-market (“ATM”) offering program pursuant to which we may, from time to time, issue and sell shares that have an aggregate offering price of $100 million. For the year ended December 31, 2023, 5.5 million shares were sold under the ATM agreement with Leerink Partners LLC and we collected a gross amount of €58.8 million. There were no shares sold under the ATM agreement during the six months ended June 30, 2024.
We plan to utilize the existing Cash, cash equivalents and Other financial assets on hand primarily to fund our operating activities associated with our research and development initiatives to continue or commence clinical trials and seek regulatory approval for our product candidates. We also expect to continue investing in laboratory and manufacturing equipment and operations to support our anticipated growth. Cash in excess of immediate requirements is invested in accordance with our investment policy with an emphasis on liquidity and capital preservation and consist primarily of cash in banks and short-term deposits.
Cash Flows
The following table summarizes our cash flows for each period presented:
| Six months ended June 30, | ||||||||
| 2024 | 2023 | |||||||
| (Euros in thousands) | ||||||||
| Net cash provided by / (used in): |
||||||||
| Operating activities |
(65,825 | ) | (30,323 | ) | ||||
| Investing activities |
(171,993 | ) | (20,555 | ) | ||||
| Financing activities |
174,079 | 35,585 | ||||||
|
|
|
|
|
|||||
| Total |
(63,739 | ) | (15,293 | ) | ||||
|
|
|
|
|
|||||
Operating Activities
We primarily derive cash from our collaboration agreements. Our cash used in operating activities is significantly influenced by our use of cash for operating expenses and working capital to support the business. Historically we experienced negative cash flows from operating activities as we have invested in the development of our technologies in our clinical and preclinical development of our product candidates.
Our net cash outflow from operating activities for the six months ended June 30, 2024 was €65.8 million. This was comprised by a loss of €21.1 million, an increase in working capital of €47.0 million, net foreign exchange differences and expected credit losses of €7.7 million, other effects of €4.3 million, and a non-cash income of €0.4 million related to the change in fair value of the warrants, partly offset by depreciation and amortization charge of €6.1 million and non-cash charges from equity-settled share-based compensation expenses for employees of €8.6 million. The increase in working capital mainly resulted from a decrease in deferred revenue, accounts payable and other liabilities of €47.0 million and an increase on in other assets and prepayments of €1.2 million, partly offset by a decrease in accounts receivable of €1.2 million.
Our net cash outflow from operating activities for the six months ended June 30, 2023 was €30.3 million. This was comprised by 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 expense 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.
Investing Activities
Our net outflow of cash from investing activities for the six months ended June, 2024 was €172.0 million. This consisted primarily of cash paid in the amount of €356.6 million for short-term deposit investments that are classified as Other financial assets and held with financial institutions to finance the company, €11.9 million cash paid for new equipment and intangible assets, partially offset by cash received from maturity of bonds and short-term deposits of €196.5 million.
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 cash paid for new equipment and intangible assets, partially offset by cash received from maturity of bonds and short-term deposits of €164.9 million.
Financing Activities
For the six months ended June 30, 2024, net cash received from financing activities amounted to €174.1 million. On January 22, 2024, the Company closed an offering of 18,313,750 ordinary shares with a public offering price of $11.00 per ordinary share. The Company received net proceeds of €173.4 million after deducting the underwriting discount and fees and offering expenses and intends to use the net proceeds from this offering to fund the continued research and development of the Group’s pipeline, the manufacturing and production of product candidates and for working capital. In addition, the Group received €1.1 million from option exercises under the Equity Plans and paid €0.4 million from lease agreements.
For the six months ended June 30, 2023, net cash received 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 collected a net amount of €37.4 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 €618.4 million as of June 30, 2024. We expect our expenses to increase in connection with our ongoing activities, particularly as we continue the research and development of, continue or commence clinical trials including GMP manufacturing of, and seek regulatory approval for, our product candidates. We believe that we have sufficient financial resources available to fund our projected operating requirements for at least the next twelve months. Because the outcome of our current and planned clinical trials is highly uncertain, we cannot reasonably estimate the actual amounts necessary to successfully complete the development and commercialization of our product candidates. For example, our costs will increase if we experience any delays in our current and planned clinical trials. Our future funding requirements will depend on many factors, including, but not limited to:
| 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, 2024 and 2023, respectively, have been prepared in accordance with International Accounting Standard 34 (Interim Financial Reporting), as issued by the International Accounting Standards Board.
The preparation of the consolidated financial statements for the fiscal year ended December 31, 2023 and the three and six months ended June 30, 2024 in accordance with IFRS required the use of estimates and assumptions by the management that affect the value of assets and liabilities – as well as contingent assets and liabilities – as reported on the balance sheet date, and revenues and expenses arising during the year. The main areas in which assumptions, estimates and the exercising of a degree of discretion are appropriate relate to the determination of revenue recognition, research and development expenses, and share-based compensations as well as income taxes.
Our estimates are based on historical experience and other assumptions that are considered appropriate in the circumstances, and parameters available when the consolidated financial statements were prepared. Existing circumstances and assumptions about future developments, however, may change due to market changes or circumstances arising that are beyond our control. Hence, our estimates may vary from the actual values.
While our material accounting policies are more fully discussed in our consolidated financial statements included in our Annual Report, we believe that the following accounting policies are critical to the process of making significant judgments and estimates in the preparation of our unaudited interim condensed consolidated financial statements.
Revenue Recognition for Collaboration Agreements
We recognize revenue through collaboration and license agreements and reimbursement for research and development costs.
Under our collaboration and license agreements, we may receive upfront licensing payments, milestone payments and reimbursement of research and development expenses. Such collaboration agreements also include licenses of certain of our IP to the respective collaborators. As these agreements are comprised of several commitments, it must be assessed whether these commitments are capable of being distinct within the context of the contract. For two of our four revenue generating collaboration agreements, we
determined that the commitments included in each agreement represented single combined performance obligations, with a single measure of progress. The performance obligation is accounted for as a performance obligation satisfied over time on a cost-to-cost basis, as our collaboration partner simultaneously receives and consumes the benefit from our performance. Upfront licensing payments and reimbursement for development expenses are initially deferred on our statement of financial position and subsequently recognized as revenue over time as costs are incurred.
For our collaboration with BMS regarding IMA401 that was signed in December 2021, we concluded that the commitments from the collaboration agreement represented two distinct performance obligations. The granted license is transferred at a point in time at the effective date of the agreement and we recognized the revenue allocated to the license at the effective date. The performance obligation related to promised clinical trial services is satisfied over time. We transfer control of these agreed services over time and therefore recognize revenue over time on a cost-to-cost basis. The transaction price allocated to the commitment for clinical trial services is initially deferred on our statement of financial position and subsequently recognized as revenue as costs are incurred.
For our collaboration with Moderna, the Group identified the following distinct performance obligations: Early TCER Activities, Advanced TCER Activities and Database Activities. The most reasonable estimation method for the Early TCER Activities and the Database Activities is the adjusted market assessment approach, due to the fact that we are able to use insights from prior collaborations as well as information implicit in the contract to estimate the stand-alone selling price. To estimate a stand-alone selling price for the performance obligation related to the Advanced TCER Activities, we concluded to use the residual approach due to the fact that the license is a unique license and there is no available market price for the license and hence no specific stand-alone selling price apart from the residual amount was identified. We evaluated each performance obligation to determine if it can be satisfied at a point in time or over time. The control over all performance obligations is transferred over time. We transfer control of these agreed services over time and will therefore recognize revenue over time as costs are incurred using a cost-to-cost method. For the Database Activities, we will recognize revenue linearly over time, as the performance obligations represent a right to access the database. At inception of the Moderna agreement, the entire upfront payment was initially deferred on our Consolidated Statement of Financial Position.
Milestone payments are generally included in the transaction price at the amount stipulated in the respective agreement and recognized to the extent that it is highly probable that a significant reversal in the amount of cumulative revenue recognized will not occur. To date, no milestone payment has been included in the transaction price and recognized into revenue.
We provide development and manufacturing work to our collaboration partners and recognize revenue over time using an input-based method to measure progress toward complete satisfaction of the service, because the collaboration partner simultaneously receives and consumes the benefits provided. Forecast values are used for the calculation of expected future revenue for the remaining term of the contract. These costs estimated as part of the budgeting process must be reviewed and approved before we can use them for recognition purposes. Significant management judgment is required to determine the level of effort required under an arrangement, and the period over which we expect to complete our performance obligations under the arrangement which includes total internal personnel costs and external costs to be incurred. Changes in these estimates can have a material effect on revenue recognized.
Share-based Compensation
The Company offers a share-based compensation plan that includes Performance-Based Options (“PSUs”) and service options including a conversion of previous share-based compensation arrangements entered into by Immatics GmbH.
The costs of equity-settled transactions are determined by the fair value at grant date, using an appropriate valuation model. Share-based expenses for the respective vesting periods, are recognized in research and development expenses and general and administrative expenses, reflecting a corresponding increase in equity.
Income Taxes
Uncertainties exist with respect to the interpretation of complex tax regulations, changes in tax laws, and the amount and timing of future taxable income. Given the wide range and complexity of existing contractual agreements, differences arising between the actual results and the assumptions made, or future changes to such assumptions, could necessitate future adjustments to tax income and expenses already recorded. Deferred tax assets are recognized for unused tax losses to the extent that it is probable that taxable profit will be available which can be utilized against the losses. Significant management judgement is required to determine the amount of deferred tax assets that can be recognized, based upon the likely timing and the level of future taxable profits together with future tax planning strategies. Due to our history of loss-making over the last several years as well as our expectation for the foreseeable future, we have not recognized any deferred tax assets on tax losses carried forward despite the net income for the year ended December 31, 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, 2024 and 2023 had no material effect on the consolidated financial statements of the Group.
In April 2024, IFRS 18, “Presentation and Disclosure in Financial Statements” was issued to achieve comparability of the financial performance of similar entities. The standard, which replaces IAS 1 “Presentation of Financial Statements”, impacts the presentation of primary financial statements and notes, including the statement of earnings where companies will be required to present separate categories of income and expense for operating, investing, and financing activities with prescribed subtotals for each new category. The standard will also require management-defined performance measures to be explained and included in a separate note within the consolidated financial statements.
The standard is effective for annual reporting periods beginning on or after January 1, 2027, including interim financial statements, and requires retrospective application. The Company is currently assessing the impact of the new standard.
Quantitative and Qualitative Disclosures about Market Risk
We are exposed to various risks in relation to financial instruments. Our principal financial instruments comprise cash and cash equivalents, short-term deposits and accounts receivables. The main purpose of these financial instruments is to invest the proceeds of capital contributions and upfront payments from collaboration agreements. We have various other financial instruments such as other receivables and trade accounts payables, which arise directly from its operations.
The main risks arising from our financial instruments are market risk and liquidity risk. The Board of Management reviews and agrees on policies for managing these risks as summarized below. We also monitor the market price risk arising from all financial instruments.
Interest rate risk
Our exposure to changes in interest rates relates to investments in deposits and to changes in the interest for overnight deposits. Changes in the general level of interest rates may lead to an increase or decrease in the fair value of these investments. Regarding the liabilities shown in the Consolidated Statement of Financial Position, we are currently not subject to major interest rate risks.
Credit risk
Financial instruments that potentially subject us to concentrations of credit and liquidity risk consist primarily of cash and cash equivalents, accounts receivables and short-term deposits. Our cash and cash equivalents and short-term deposits are denominated in Euros and US Dollars and maintained with three financial institutions in Germany and two in the United States. Our accounts receivables are denominated in Euros.
We continually monitor our positions with, and the credit quality of, the financial institutions and corporation, which are counterparts to our financial instruments and we are not anticipating non-performance. The maximum default risk corresponds to the carrying amount of the financial assets shown in the statement of financial position. We monitor the risk of a liquidity shortage. The main factors considered here are the maturities of financial assets, as well as expected cash flows from equity measures.
Currency risk
Currency risk shows the risk that the value of a financial instrument will fluctuate due to changes in foreign exchange rates. In particular it poses a threat if the value of the currency in which liabilities are priced appreciates relative to the currency of the assets. Our business transactions are generally conducted in Euros and U.S. dollars. We aim to match EUR cash inflows with EUR cash outflows and U.S. dollar cash inflows with U.S. Dollar cash outflows where possible. Our objective of currency risk management is to identify, manage and control currency risk exposures within acceptable parameters.
Our cash and cash equivalents were €158.1 million as of June 30, 2024. Approximately 81% of our cash and cash equivalents were held in Germany, of which approximately 76% were denominated in Euros and 24% 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 €116.7 million and U.S. Dollars in the amount of €256.2 million as of June 30, 2024.
Market risk and currency risk of warrants
Our activities expose us to the financial risks of changes in price of the warrants. As the warrants are recognized at fair value on the consolidated statement of financial position of the Group, our exposure to market risks results from the volatility of the warrants price. The Warrants are publicly traded at the NASDAQ Stock Exchange. A reasonable increase (decrease) in the warrant price by 10%, with all other variables held constant, would lead to a (loss) gain before tax of €1.9 million with a corresponding effect in the equity as of June 30, 2024.
OTHER INFORMATION
Legal Proceedings
From time to time, we may be subject to various legal proceedings and claims that arise in the ordinary course of our business activities. TaurX has filed a trademark opposition against our registered Trademark IMTX in the EU. Discovery and preliminary procedural matters remain ongoing and the parties are engaged in settlement discussion. The results of litigation and claims cannot be predicted with certainty. As of the date of this Report, we do not believe that we are party to any claim or litigation, the outcome of which would, individually or in the aggregate, be reasonably expected to have a material adverse effect on our business.
Risk Factors
There have been no material changes from the risk factors described in the section titled “Risk Factors” in our Annual Report.
Exhibit 99.2
PRESS RELEASE
Immatics Announces Second Quarter 2024
Financial Results and Business Update
| • | Clinical data from May 2024 on ACTengine® IMA203 targeting PRAME in 30 heavily pre-treated metastatic melanoma patients at RP2D: 55% confirmed objective response rate, median duration of response of 13.5 months; IMA203 continues to maintain a favorable tolerability profile |
| • | Registration-enabling randomized Phase 2/3 trial for ACTengine® IMA203 in 2L+ melanoma planned to commence in 2024 |
| • | Next data update on IMA203 and IMA203CD8 (GEN2) to be presented at medical conferences in 2H 2024 |
| • | First Phase 1 dose escalation clinical data from Immatics’ next-generation, half-life extended TCR Bispecific, TCER® IMA401 (MAGEA4/8), to be presented as an oral presentation at the European Society for Medical Oncology (ESMO) Congress 2024 |
| • | First next-generation, half-life extended TCER® IMA402 (PRAME) dose escalation data to be announced later in 2H 2024 |
| • | Appointment of Alise Reicin M.D. to Board of Directors |
| • | Cash and cash equivalents as well as other financial assets amount to $568.5 million1 (€531.1 million) as of June 30, 2024, funding company operations into 2027 |
Houston, Texas and Tuebingen, Germany, August 13, 2024 – Immatics N.V. (NASDAQ: IMTX, “Immatics” or the “Company”), 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, 2024.
“It is an exciting time for Immatics as we prepare to reach several major clinical milestones in the second half of the year. Starting with the presentation of the first clinical data on our TCR Bispecific, TCER® IMA401, at ESMO, followed by further data updates from our cell therapy pipeline and the initiation of the IMA203 registration-enabling clinical trial, we look forward to the continued advancement of our product candidates in the coming months,” said Harpreet Singh, Ph.D., CEO and Co-Founder of Immatics. “Patients with advanced solid tumors are in need of transformative therapies that make a meaningful difference in their quality of life. With each clinical milestone we reach, we move one step closer to making an impact in the lives of these patients.”
| 1 | All amounts translated using the exchange rate published by the European Central Bank in effect as of June 30, 2024 (1 EUR = 1.0705 USD). |
| Immatics Press Release August 13, 2024 | 1 | 11 |
Second Quarter 2024 and Subsequent Company Progress
ACTengine® Cell Therapy Program
ACTengine® IMA203 and IMA203CD8 (GEN2) monotherapy
On May 14, 2024, Immatics provided a data update on IMA203 monotherapy targeting PRAME from the ongoing Phase 1 trial at the recommended Phase 2 dose (RP2D, 1 to 10 billion total TCR-T cells) in 30 heavily pretreated metastatic melanoma patients evaluable for efficacy.
As of the data cut-off on April 25, 2024, treatment with IMA203 monotherapy in the efficacy population has demonstrated a confirmed objective response rate (cORR) of 55% (16/29), a disease control rate of 90% (27/30) and tumor shrinkage in 87% (26/30) of patients.
Median duration of response (mDOR) was 13.5 months (min 1.2+, max 21.5+ months) including 11 of 16 confirmed objective responses ongoing at data cut-off and longest duration of response ongoing at >21 months after infusion.
Confirmed response rates are similar across all melanoma subtypes (56% (9/16) in cutaneous melanoma and 54% (7/13) in other melanoma subtypes). IMA203 has exhibited a favorable tolerability profile (N=65 patients across all dose levels and all tumor types).
The next data update, which will include translational and clinical data for IMA203, as well as further details on the clinical trial design for the planned IMA203 Phase 2/3 study, will be presented in 2H 2024 at a medical conference.
Immatics is continuing dose escalation of IMA203CD8 (GEN2) with the goal of defining the optimal dose for further development. The next data update for IMA203CD8 (GEN2) is planned for 2H 2024 with a focus on continued dose escalation data in melanoma patients. In addition to treating melanoma patients, Immatics has also started to expand its clinical footprint outside of melanoma to address a broader patient population with a particular focus on ovarian and uterine cancers.
TCR Bispecifics Programs
Immatics’ T cell engaging receptor (TCER®) candidates are next-generation, half-life extended TCR Bispecific molecules. They are designed to maximize efficacy while minimizing toxicities and provide a patient-convenient dosing schedule through the proprietary format consisting of a high-affinity TCR domain against the tumor target and a low-affinity T cell recruiter binding to the T cell.
| Immatics Press Release August 13, 2024 | 2 | 11 |
Upcoming milestones for Immatics’ clinical TCER® pipeline
Martin Wermke, M.D. will present the first clinical data from Immatics’ IMA401 (MAGEA4/8) at the ESMO Congress during an oral presentation titled, Initial safety, pharmacokinetics, and anti-tumor activity data of TCER IMA401, a MAGEA4/8-directed half-life extended TCR Bispecific, in Phase 1 dose escalation, on September 16, 2024, at 11:25 CEST.
Data from approximately 30 patients from the dose escalation phase will be presented. Key objectives include: (1) Demonstrating tolerability of the novel, next-generation, half-life extended TCR Bispecifics format; (2) optimizing dosing schedule to a less frequent regimen during dose escalation, based on pharmacokinetics data; and (3) demonstrating initial clinical anti-tumor activity.
IMA402 (PRAME) data are planned to be announced later in 2H 2024 and will include data from at least 15 patients in early stages of dose escalation across multiple solid cancers, but initially focused on melanoma.
TCER® IMA401 (MAGEA4/8)
The Phase 1 dose escalation basket trial to evaluate safety, tolerability and initial anti-tumor activity of TCER® IMA401 in patients with recurrent and/or refractory solid tumors is ongoing. IMA401 targets an HLA-A*02:01-presented peptide that occurs identically in two different proteins, MAGEA4 and MAGEA8. This target peptide has been selected based on natural expression in native solid tumors at particularly high target density (peptide copy number per tumor cell identified by Immatics’ proprietary quantitative mass spectrometry engine XPRESIDENT® is >5x higher than for a MAGEA4 peptide target used in other clinical trials). MAGEA4 and MAGEA8 are expressed in multiple solid cancers including lung cancer, head and neck cancer, melanoma, ovarian cancer, sarcoma and others.
IMA401 is being developed in collaboration with Bristol Myers Squibb.
TCER® IMA402 (PRAME)
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 2023. Initial focus indications are ovarian cancer, lung cancer, uterine cancer and cutaneous and uveal melanoma, among others. IMA402 targets an HLA-A*02:01-presented peptide derived from the tumor antigen PRAME. This target peptide has been selected based on natural expression in native solid primary tumors and metastases at particularly high target density (peptide copy number per tumor cell identified by Immatics’ proprietary quantitative mass spectrometry engine XPRESIDENT®).
| Immatics Press Release August 13, 2024 | 3 | 11 |
Corporate Development
In July 2024, Alise Reicin, M.D., was appointed to Immatics’ Board of Directors as the Company is advancing its pipeline of TCR-based cell therapy and bispecific product candidates into the next phase of development. Dr. Reicin brings extensive experience in early- and late-stage clinical development and has led the successful development of multiple important new therapies, including Keytruda®.
Second Quarter 2024 Financial Results
Cash Position: Cash and cash equivalents as well as other financial assets total €531.1 million ($568.5 million1) as of June 30, 2024, compared to €425.9 million ($455.9 million1) as of December 31, 2023. The increase is mainly due to the public offering in January 2024, partly offset by ongoing research and development activities. The Company projects a cash runway into 2027.
Revenue: Total revenue, consisting of revenue from collaboration agreements, was €18.8 million ($20.1 million1) for the three months ended June 30, 2024, compared to €22.4 million ($24.0 million1) for the three months ended June 30, 2023. The decrease is mainly the result of a one-time revenue of €13.7 million associated with an opt-in payment by BMS during the three months ended June 30, 2023.
Research and Development Expenses: R&D expenses were €35.2 million ($37.7 million1) for the three months ended June 30, 2024, compared to €27.3 million ($29.2 million1) for the three months ended June 30, 2023. The increase mainly resulted from costs associated with the advancement of the clinical pipeline candidates.
General and Administrative Expenses: G&A expenses were €10.1 million ($10.8 million1) for the three months ended June 30, 2024, compared to €9.4 million ($10.1 million1) for the three months ended June 30, 2023.
Net Profit and Loss: Net loss was €18.0 million ($19.3 million1) for the three months ended June 30, 2024, compared to a net loss of €24.6 million ($26.3 million1) for the three months ended June 30, 2023. The decrease in net loss despite decreased revenue and increased operating expenses is driven by an increased financial result.
| Immatics Press Release August 13, 2024 | 4 | 11 |
Full financial statements can be found in the 6-K filed with the Securities and Exchange Commission (SEC) on August 13, 2024, and published on the SEC website under www.sec.gov.
Upcoming Investor Conferences
Jefferies London Healthcare Conference, London, United Kingdom – November 19 – 21, 2024
To see the full list of events and presentations, visit www.investors.immatics.com/events-presentations.
- END -
About Immatics
Immatics combines the discovery of true targets for cancer immunotherapies with the development of the right T cell receptors with the goal of enabling a robust and specific T cell response against these targets. This deep know-how is the foundation for our pipeline of Adoptive Cell Therapies and TCR Bispecifics as well as our partnerships with global leaders in the pharmaceutical industry. We are committed to delivering the power of T cells and to unlocking new avenues for patients in their fight against cancer.
Immatics intends to use its website www.immatics.com as a means of disclosing material non-public information. For regular updates you can also follow us on X, Instagram and LinkedIn.
Forward-Looking Statements
Certain statements in this press release may be considered forward-looking statements. Forward-looking statements generally relate to future events or the Company’s future financial or operating performance. For example, statements concerning timing of data read-outs for product candidates, the timing, outcome and design of clinical trials, the nature of clinical trials (including whether such clinical trials will be registration-enabling), the timing of IND or CTA filing for pre-clinical stage product candidates, estimated market opportunities of product candidates, the Company’s focus on partnerships to advance its strategy, and other metrics are forward-looking statements. In some cases, you can identify forward-looking statements by terminology such as “may”, “should”, “expect”, “plan”, “target”, “intend”, “will”, “estimate”, “anticipate”, “believe”, “predict”, “potential” or “continue”, or the negatives of these terms or variations of them or similar terminology. Such forward-looking statements are subject to risks, uncertainties, and other factors which could cause actual results to differ materially from those expressed or
| Immatics Press Release August 13, 2024 | 5 | 11 |
implied by such forward-looking statements. These forward-looking statements are based upon estimates and assumptions that, while considered reasonable by Immatics and its management, are inherently uncertain. New risks and uncertainties may emerge from time to time, and it is not possible to predict all risks and uncertainties. Factors that may cause actual results to differ materially from current expectations include, but are not limited to, various factors beyond management’s control including general economic conditions and other risks, uncertainties and factors set forth in the Company’s Annual Report on Form 20-F and other filings with the Securities and Exchange Commission (SEC). Nothing in this press release should be regarded as a representation by any person that the forward-looking statements set forth herein will be achieved or that any of the contemplated results of such forward-looking statements will be achieved. You should not place undue reliance on forward-looking statements, which speak only as of the date they are made. The Company undertakes no duty to update these forward-looking statements. All the scientific and clinical data presented within this press release are – by definition prior to completion of the clinical trial and a clinical study report – preliminary in nature and subject to further quality checks including customary source data verification.
For more information, please contact:
Media
Trophic Communications
Phone: +49 171 3512733
immatics@trophic.eu
Immatics N.V.
Jordan Silverstein
Head of Strategy
Phone: +1 346 319-3325
InvestorRelations@immatics.com
| Immatics Press Release August 13, 2024 | 6 | 11 |
Immatics N.V. and subsidiaries
Condensed Consolidated Statement of Loss of Immatics N.V.
| Three months ended June 30, | Six months ended June 30, | |||||||||||||||
| 2024 | 2023 | 2024 | 2023 | |||||||||||||
| (Euros in thousands, except per share data) |
(Euros in thousands, except per share data) |
|||||||||||||||
| Revenue from collaboration agreements |
18,755 | 22,354 | 49,024 | 32,150 | ||||||||||||
| Research and development expenses |
(35,216 | ) | (27,317 | ) | (67,324 | ) | (54,898 | ) | ||||||||
| General and administrative expenses |
(10,128 | ) | (9,358 | ) | (21,770 | ) | (18,944 | ) | ||||||||
| Other income |
25 | 6 | 37 | 948 | ||||||||||||
|
|
|
|
|
|
|
|
|
|||||||||
| Operating result |
(26,564 | ) | (14,315 | ) | (40,033 | ) | (40,744 | ) | ||||||||
| Change in fair value of liabilities for warrants |
(648 | ) | (13,105 | ) | 395 | (5,708 | ) | |||||||||
| Other financial income |
9,665 | 3,954 | 20,580 | 6,748 | ||||||||||||
| Other financial expenses |
(305 | ) | (1,144 | ) | (515 | ) | (4,653 | ) | ||||||||
|
|
|
|
|
|
|
|
|
|||||||||
| Financial result |
8,712 | (10,295 | ) | 20,460 | (3,613 | ) | ||||||||||
|
|
|
|
|
|
|
|
|
|||||||||
| Loss before taxes |
(17,852 | ) | (24,610 | ) | (19,573 | ) | (44,357 | ) | ||||||||
| Taxes on income |
(170 | ) | — | (1,503 | ) | — | ||||||||||
| Net loss |
(18,022 | ) | (24,610 | ) | (21,076 | ) | (44,357 | ) | ||||||||
|
|
|
|
|
|
|
|
|
|||||||||
| Net loss per share: |
||||||||||||||||
| Basic |
(0.17 | ) | (0.32 | ) | (0.21 | ) | (0.58 | ) | ||||||||
| Diluted |
(0.17 | ) | (0.32 | ) | (0.21 | ) | (0.58 | ) | ||||||||
| Immatics Press Release August 13, 2024 | 7 | 11 |
Immatics N.V. and subsidiaries
Condensed Consolidated Statement of Comprehensive Loss of Immatics N.V.
| Three months ended June 30, | Six months ended June 30, | |||||||||||||||
| 2024 | 2023 | 2024 | 2023 | |||||||||||||
| (Euros in thousands) | (Euros in thousands) | |||||||||||||||
| Net loss |
(18,022 | ) | (24,610 | ) | (21,076 | ) | (44,357 | ) | ||||||||
| Other comprehensive income |
||||||||||||||||
| Items that may be reclassified subsequently to profit or loss |
||||||||||||||||
| Currency translation differences from foreign operations |
462 | (224 | ) | 798 | 340 | |||||||||||
|
|
|
|
|
|
|
|
|
|||||||||
| Total comprehensive loss for the year |
(17,560 | ) | (24,834 | ) | (20,278 | ) | (44,017 | ) | ||||||||
|
|
|
|
|
|
|
|
|
|||||||||
| Immatics Press Release August 13, 2024 | 8 | 11 |
Immatics N.V. and subsidiaries
Condensed Consolidated Statement of Financial Position of Immatics N.V.
| As of | ||||||||
| June 30, 2024 | December 31, 2023 | |||||||
| (Euros in thousands) | ||||||||
| Assets |
||||||||
| Current assets |
||||||||
| Cash and cash equivalents |
158,143 | 218,472 | ||||||
| Other financial assets |
372,964 | 207,423 | ||||||
| Accounts receivables |
2,811 | 4,093 | ||||||
| Other current assets |
25,200 | 19,382 | ||||||
|
|
|
|
|
|||||
| Total current assets |
559,118 | 449,370 | ||||||
| Non-current assets |
||||||||
| Property, plant and equipment |
50,289 | 43,747 | ||||||
| Intangible assets |
1,608 | 1,523 | ||||||
| Right-of-use assets |
14,616 | 13,308 | ||||||
| Other non-current assets |
1,336 | 2,017 | ||||||
|
|
|
|
|
|||||
| Total non-current assets |
67,849 | 60,595 | ||||||
|
|
|
|
|
|||||
| Total assets |
626,967 | 509,965 | ||||||
|
|
|
|
|
|||||
| Liabilities and shareholders’ equity |
||||||||
| Current liabilities |
||||||||
| Provisions |
3,437 | — | ||||||
| Accounts payables |
18,791 | 25,206 | ||||||
| Deferred revenue |
95,521 | 100,401 | ||||||
| Liabilities for warrants |
18,598 | 18,993 | ||||||
| Lease liabilities |
3,178 | 2,604 | ||||||
| Other current liabilities |
10,021 | 9,348 | ||||||
|
|
|
|
|
|||||
| Total current liabilities |
149,546 | 156,552 | ||||||
| Non-current liabilities |
||||||||
| Deferred revenue |
75,298 | 115,527 | ||||||
| Lease liabilities |
14,235 | 12,798 | ||||||
| Other non-current liabilities |
— | 4 | ||||||
|
|
|
|
|
|||||
| Total non-current liabilities |
89,533 | 128,329 | ||||||
| Shareholders’ equity |
||||||||
| Share capital |
1,031 | 847 | ||||||
| Share premium |
1,006,064 | 823,166 | ||||||
| Accumulated deficit |
(618,369 | ) | (597,293 | ) | ||||
| Other reserves |
(838 | ) | (1,636 | ) | ||||
|
|
|
|
|
|||||
| Total shareholders’ equity |
387,888 | 225,084 | ||||||
|
|
|
|
|
|||||
| Total liabilities and shareholders’ equity |
626,967 | 509,965 | ||||||
|
|
|
|
|
|||||
| Immatics Press Release August 13, 2024 | 9 | 11 |
Immatics N.V. and subsidiaries
Condensed Consolidated Statement of Cash Flows of Immatics N.V.
| Six months ended June 30, | ||||||||
| 2024 | 2023 | |||||||
| (Euros in thousands) | ||||||||
| Cash flows from operating activities |
||||||||
| Net loss |
(21,076 | ) | (44,357 | ) | ||||
| Taxes on income |
1,503 | — | ||||||
| Loss before tax |
(19,573 | ) | (44,357 | ) | ||||
| Adjustments for: |
||||||||
| Interest income |
(12,660 | ) | (4,999 | ) | ||||
| Depreciation and amortization |
6,116 | 3,666 | ||||||
| Interest expenses |
420 | 401 | ||||||
| Equity-settled share-based payment |
8,605 | 11,615 | ||||||
| Loss from disposal of fixed assets |
1 | — | ||||||
| Net foreign exchange differences and expected credit losses |
(7,723 | ) | 4,081 | |||||
| Change in fair value of liabilities for warrants |
(395 | ) | 5,708 | |||||
| Changes in: |
||||||||
| Decrease in accounts receivables |
1,283 | 781 | ||||||
| Decrease/(increase) in other assets |
(1,246 | ) | 765 | |||||
| (Decrease) in deferred revenue, accounts payables and other liabilities |
(48,493 | ) | (9,889 | ) | ||||
| Interest received |
8,260 | 2,051 | ||||||
| Interest paid |
(420 | ) | (146 | ) | ||||
| Income tax paid |
— | — | ||||||
|
|
|
|
|
|||||
| Net cash used in operating activities |
(65,825 | ) | (30,323 | ) | ||||
|
|
|
|
|
|||||
| Cash flows from investing activities |
||||||||
| Payments for property, plant and equipment |
(11,797 | ) | (15,004 | ) | ||||
| Payments for intangible assets |
(148 | ) | (154 | ) | ||||
| Payments for investments classified in other financial assets |
(356,596 | ) | (170,326 | ) | ||||
| Proceeds from maturity of investments classified in other financial assets |
196,548 | 164,929 | ||||||
|
|
|
|
|
|||||
| Net cash used in investing activities |
(171,993 | ) | (20,555 | ) | ||||
|
|
|
|
|
|||||
| Cash flows from financing activities |
||||||||
| Proceeds from issuance of shares to equity holders |
174,476 | 38,608 | ||||||
| Transaction costs deducted from equity |
— | (1,157 | ) | |||||
| Repayments related to lease liabilities |
(397 | ) | (1,866 | ) | ||||
|
|
|
|
|
|||||
| Net cash provided by financing activities |
174,079 | 35,585 | ||||||
|
|
|
|
|
|||||
| Net decrease in cash and cash equivalents |
(63,739 | ) | (15,293 | ) | ||||
|
|
|
|
|
|||||
| Cash and cash equivalents at beginning of the year |
218,472 | 148,519 | ||||||
|
|
|
|
|
|||||
| Effects of exchange rate changes and expected credit losses on cash and cash equivalents |
3,410 | (2,821 | ) | |||||
|
|
|
|
|
|||||
| Cash and cash equivalents at end of the year |
158,143 | 130,405 | ||||||
|
|
|
|
|
|||||
| Immatics Press Release August 13, 2024 | 10 | 11 |
Immatics N.V. and subsidiaries
Condensed Consolidated Statement of Changes in Shareholders’ Equity of Immatics N.V.
| (Euros in thousands) | Share capital |
Share premium |
Accumulated deficit |
Other reserves |
Total share- holders’ equity |
|||||||||||||||
| Balance as of January 1, 2023 |
767 | 714,177 | (500,299 | ) | (1,481 | ) | 213,164 | |||||||||||||
| Other comprehensive income |
— | — | — | 340 | 340 | |||||||||||||||
| Net loss |
— | — | (44,357 | ) | — | (44,357 | ) | |||||||||||||
| Comprehensive loss for the year |
— | — | (44,357 | ) | 340 | (44,017 | ) | |||||||||||||
| Equity-settled share-based compensation |
— | 11,615 | — | — | 11,615 | |||||||||||||||
| Share options exercised |
— | 40 | — | — | 40 | |||||||||||||||
| Issue of share capital – net of transaction costs |
37 | 37,374 | — | — | 37,411 | |||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|||||||||||
| Balance as of June 30, 2023 |
804 | 763,206 | (544,656 | ) | (1,141 | ) | 218,213 | |||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|||||||||||
| Balance as of January 1, 2024 |
847 | 823,166 | (597,293 | ) | (1,636 | ) | 225,084 | |||||||||||||
| Other comprehensive income |
— | — | — | 798 | 798 | |||||||||||||||
| Net loss |
— | — | (21,076 | ) | — | (21,076 | ) | |||||||||||||
| Comprehensive loss for the year |
— | — | (21,076 | ) | 798 | (20,278 | ) | |||||||||||||
| Equity-settled share-based compensation |
— | 8,605 | — | — | 8,605 | |||||||||||||||
| Share options exercised |
1 | 1,036 | — | — | 1,037 | |||||||||||||||
| Issue of share capital – net of transaction costs |
183 | 173,257 | — | — | 173,440 | |||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|||||||||||
| Balance as of June 30, 2024 |
1,031 | 1,006,064 | (618,369 | ) | (838 | ) | 387,888 | |||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|||||||||||
| Immatics Press Release August 13, 2024 | 11 | 11 |