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Immatics N.V.(IMTX) - 2023 Q4 - Annual Report
2024-03-21 11:23
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 20-F (Mark One) ☐ REGISTRATION STATEMENT PURSUANT TO SECTION 12(b) OR (g) OF THE SECURITIES EXCHANGE ACT OF 1934 OR ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 OR ☐ SHELL COMPANY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES ...
Immatics N.V.(IMTX) - 2023 Q2 - Quarterly Report
2023-08-17 11:05
Exhibit 99.1 PRELIMINARY NOTE The unaudited condensed Consolidated Financial Statements for the three and six-month periods ended June 30, 2023, included herein, have been prepared in accordance with International Accounting Standard 34 ("Interim Financial Reporting"), as issued by the International Accounting Standards Board ("IASB"). The Consolidated Financial Statements are presented in euros. All references in this interim report to "$," and "U.S. dollars" mean U.S. dollars and all references to "€" and ...
Immatics N.V.(IMTX) - 2023 Q1 - Quarterly Report
2023-05-16 11:05
Exhibit 99.1 PRELIMINARY NOTE The unaudited condensed Consolidated Financial Statements for the three-month period ended March 31, 2023, included herein, have been prepared in accordance with International Accounting Standard 34 ("Interim Financial Reporting"), as issued by the International Accounting Standards Board ("IASB"). The Consolidated Financial Statements are presented in euros. All references in this interim report to "$," and "U.S. dollars" mean U.S. dollars and all references to "€" and "euros" ...
Immatics N.V.(IMTX) - 2022 Q4 - Annual Report
2023-03-22 10:54
Financial Position - As of December 31, 2022, the company had accumulated consolidated losses of €500.3 million and expects to continue incurring significant operating losses in the future[30]. - The company had €362.2 million in cash and cash equivalents and other financial assets as of December 31, 2022, which is projected to fund operating requirements for at least the next twelve months[37]. - The company has German federal net operating loss carryforwards of €210.4 million and U.S. federal net operating loss carryforwards of €146.8 million as of December 31, 2022[42]. - The company has no products approved for commercial sale and has not generated revenue from operations, indicating a reliance on additional capital to fund operations and product development[30]. Clinical Trials and Product Development - The company is conducting clinical trials for IMA201, IMA203, and IMA401, with no assurance that any of these product candidates will prove to be safe, effective, or commercially viable[47]. - The regulatory approval processes for the company's product candidates are lengthy and uncertain, which may delay or prevent commercialization[32]. - The company faces substantial competition in the biotechnology sector, which may impact its ability to successfully develop and commercialize its product candidates[32]. - The company relies on third parties for conducting preclinical studies and clinical trials, which poses risks if these parties do not fulfill their obligations[32]. - The company expects to incur substantial expenses related to research and development, regulatory approvals, and commercialization activities in the foreseeable future[36]. Regulatory Challenges - The company is exposed to risks related to currency exchange rates, particularly between the euro and the U.S. dollar, which could adversely affect its financial condition[41]. - Delays in clinical trials may arise from negative preclinical data, regulatory clearance issues, and difficulties in patient enrollment, potentially impacting research and development efforts[6]. - The company anticipates that chemistry, manufacturing, and control topics will be a focus during IND reviews, which may delay IND approvals by the FDA[54]. - Patient enrollment challenges could significantly delay the receipt of necessary regulatory approvals, with various factors contributing to these difficulties[55]. - The prevalence of specific genetic markers, such as HLA-A*02, limits the eligible patient population for clinical trials, affecting recruitment efforts[58]. - Competition from other clinical trials for similar therapies may reduce the number of available patients, complicating enrollment processes[59]. - Clinical trial costs are expected to be significantly higher than conventional therapies due to the complexity of trial designs and regulatory requirements[60]. - The company faces potential delays in clinical trials due to undesirable side effects or adverse events associated with product candidates, which could impact regulatory approval[64]. - Preliminary interim data from clinical trials may change as more data becomes available, highlighting the uncertainty in predicting final outcomes[74]. - The company is responsible for manufacturing costs associated with patients who do not receive the product due to various reasons, potentially increasing overall clinical trial expenses[63]. - The development of companion diagnostics is crucial for supporting larger clinical trials, and any delays in this area could hinder the progress of product candidates[62]. - The company is conducting Phase 1 clinical trials with significant discretion over patient selection, which may lead to selection bias and affect interim and final efficacy data[75]. - Preliminary results from ongoing clinical trials may not predict outcomes in completed trials, and final data could materially differ from preliminary data[76]. - The company has developed new processes for more efficient manufacturing of ACT, but these changes may require additional testing and increase costs and timelines[78]. - Regulatory authorities may require additional non-clinical studies or trials for TCR Bispecific product candidates, potentially increasing development costs and timelines[79]. - The regulatory approval process is lengthy and uncertain, with no assurance that product candidates will receive approval from the FDA, EMA, or other authorities[80]. - The company may face challenges in obtaining regulatory approval due to the novel nature of its product candidates and potential additional requirements from regulatory authorities[81]. - The regulatory landscape for gene therapy and cell therapy products is evolving, which may lead to unexpected costs and delays in obtaining approvals[87]. - The company is evaluating its ACT and TCR Bispecifics product candidates in combination with other therapies, which may complicate clinical trial designs and regulatory requirements[91]. - Certain clinical trials are being conducted outside the United States, and the FDA may not accept data from these trials, potentially leading to additional trials and costs[95]. - If the FDA does not accept data from foreign trials, it could delay or halt the development of product candidates[96]. - The company may seek accelerated approval for some product candidates, but this does not guarantee a faster development or regulatory review process[97]. - The FDA requires confirmatory clinical trials for treatments granted accelerated approval, and failure to complete these trials may lead to withdrawal of approval[98]. - Orphan drug designation can provide financial incentives, including grant funding and tax advantages, but obtaining and maintaining this designation can be challenging[100]. - In the U.S., orphan drug exclusivity lasts for seven years for the first approved indication, while in the EU, it provides ten years of market exclusivity[102]. - The company does not currently hold Breakthrough Therapy Designation, Fast Track Designation, or Priority Review Designation for its product candidates[104]. - The EMA's PRIME status allows for accelerated assessment of marketing authorization applications, reducing the review period from 210 days to 150 days[106]. Manufacturing and Supply Chain Risks - Manufacturing of cellular product candidates is complex and may lead to delays due to logistical issues or contamination risks[113]. - The company must maintain a chain of identity for patient-specific cellular materials, which is critical for regulatory compliance[114]. - Scaling manufacturing processes for advanced clinical trials poses risks, including cost overruns and potential issues with process reproducibility[116]. - Regulatory authorities may impose ongoing requirements for post-approval studies, and failure to comply could result in withdrawal of approval[109]. - The manufacturing capabilities for the allogenic cellular therapy product candidate IMA30x are still under development, with no assurance of establishing a robust production process that meets FDA and EMA requirements[117]. - Manufacturing of TCR Bispecifics (TCER) is at risk of product loss due to contamination and equipment issues, which could lead to significant delays and increased costs in the development program[118]. - Any failure to comply with cGMP and cGTP requirements could significantly impair the ability to develop and commercialize product candidates, potentially leading to delays in clinical trials[119]. - TCR Bispecific product candidates may degrade or become contaminated, causing delays in development programs if replacements cannot be made in a timely manner[120]. - The company is constructing its own manufacturing facility, which is expected to be time-consuming and expensive, with no prior experience in large-scale manufacturing[121]. - The manufacturing process for biopharmaceutical products is complex and requires significant expertise, which may lead to difficulties in scaling production and quality control[123]. Commercialization Challenges - The company has never commercialized a product and lacks an active sales force or commercial infrastructure, which may hinder successful commercialization of product candidates[126]. - Market acceptance of product candidates is heavily dependent on perceptions of safety and effectiveness, which could be influenced by competitors' products[132]. - Coverage and reimbursement for product candidates may be limited, affecting the ability to sell products profitably and recoup investments[139]. - Changes in healthcare spending and policies could adversely affect the company's business model and revenue prospects[144]. - The company is facing potential adverse impacts on product revenues due to federal and state initiatives aimed at reducing healthcare costs, particularly affecting Medicare and Medicaid programs[145]. Collaboration and Intellectual Property Risks - The reliance on third-party clinical research organizations (CROs) for preclinical studies and clinical trials may lead to delays or failures in obtaining regulatory approvals if these parties do not perform their obligations effectively[146]. - The company is constructing a state-of-the-art GMP manufacturing facility in the Houston metropolitan area to scale cell therapies for pivotal trials and initial commercial manufacturing[154]. - The company has contractual agreements with GMP suppliers for lentiviral vectors, which are critical raw materials for manufacturing genetically modified T cell products[154]. - The company’s dependence on third-party manufacturers exposes it to risks related to compliance with regulatory requirements, which could impact the ability to secure or maintain regulatory approvals for product candidates[157]. - The termination of collaboration agreements, such as the one with GlaxoSmithKline in 2022, may result in the loss of future milestone or royalty payments, affecting the company's financial position[165]. - The company plans to develop companion diagnostics for its product candidates, which may require significant resources and time, and relies on third parties for successful development and commercialization[160]. - The company may face challenges in establishing and maintaining collaborations with third parties, which are essential for the development and commercialization of its product candidates[164]. - The limited number of manufacturers capable of producing cellular therapy products under cGMP and cGTP regulations may hinder the company's ability to find suitable replacement manufacturers if needed[158]. - The company’s financial position may be adversely affected if collaborators fail to meet their obligations or prioritize resources for the company's product candidates[167]. - The company relies on third-party licensed intellectual property, and termination of these licenses could significantly harm its business[170]. - The company faces competition in obtaining strategic collaborations and licenses, which may increase costs and disrupt operations[169]. Patent and Legal Risks - The patent protection landscape is uncertain, and the company may not be able to secure adequate patent rights for its product candidates[173]. - The company may incur substantial costs related to litigation over intellectual property rights, which could impact its financial stability[184]. - If the company fails to comply with patent agency requirements, it risks losing patent rights, allowing competitors to enter the market[183]. - The company may need to participate in interference proceedings to determine priority of invention, which could result in unfavorable outcomes[185]. - The company’s ability to commercialize products may be adversely affected if it cannot maintain its licensing arrangements on acceptable terms[171]. - The company may face challenges in enforcing its patents, which could lead to loss of exclusivity and competitive advantage[180]. - The complexity and time-consuming nature of the patent application process may hinder the company’s ability to protect its innovations[174]. - The company may be required to pay substantial damages if found to infringe on third-party intellectual property rights, impacting its operations[178]. - The company faces risks of patent invalidation or unenforceability if challenged in court, which could materially impact its business[187]. - There are potential claims regarding the inventorship or ownership of patents, which may arise from former employees or collaborators[188]. - Under the German Employee Invention Act, employees may retain rights to patents, which could lead to increased compensation demands and affect the company's operations[189]. - Litigation may be necessary to defend against claims challenging inventorship or ownership, potentially resulting in substantial costs and loss of valuable intellectual property rights[190]. - The company relies on trade secret protection and confidentiality agreements, but there is no guarantee that these will prevent unauthorized disclosure of proprietary information[192]. - Claims may arise that the company or its employees have wrongfully used or disclosed third-party confidential information, leading to potential litigation and loss of intellectual property rights[193]. - Changes in patent law could diminish the value of patents, impacting the company's ability to protect its products[194]. - The company may struggle to protect its intellectual property rights globally, as legal protections vary significantly by country[196]. - Patent applications may be challenged or fail to result in issued patents, limiting the company's competitive advantages[197]. - The limited lifespan of patents may expose the company to competition from similar products once patents expire, adversely affecting its business[200]. - The company faces significant risks related to intellectual property rights, which may not adequately protect its competitive advantage[204]. Human Resources and Industry Competition - The company is highly dependent on key personnel, and the loss of any executive officers or key employees could delay product development and harm the business[207]. - The biotechnology industry is characterized by intense competition, with larger competitors having significantly greater financial resources and capabilities[217]. - The company may encounter difficulties in managing growth and expanding operations, which could disrupt its ability to achieve research and commercialization goals[210]. - Increased costs associated with being a public company may divert management's attention from research and development activities[215]. - The company anticipates facing increased competition as additional companies enter the market and scientific developments accelerate[218]. - If the company does not achieve projected development and commercialization goals within announced timeframes, it may harm the business[219]. - Health epidemics could adversely affect the company's operations and disrupt clinical trials and product supply[206]. - The company relies on independent organizations and consultants for services, and any inability to manage these relationships could delay clinical trials[213]. - The company may not be able to attract and retain highly qualified personnel due to intense competition in the biotechnology industry[209].
Immatics N.V.(IMTX) - 2022 Q3 - Quarterly Report
2022-11-17 12:13
Exhibit 99.1 PRELIMINARY NOTE The unaudited condensed Consolidated Financial Statements for the three and nine-month periods ended September 30, 2022, included herein, have been prepared in accordance with International Accounting Standard 34 ("Interim Financial Reporting"), as issued by the International Accounting Standards Board ("IASB"). The Consolidated Financial Statements are presented in euros. All references in this interim report to "$," and "U.S. dollars" mean U.S. dollars and all references to " ...
Immatics N.V.(IMTX) - 2022 Q2 - Quarterly Report
2022-06-02 11:17
[Unaudited Condensed Consolidated Financial Statements](index=2&type=section&id=Unaudited%20Condensed%20Consolidated%20Financial%20Statements) [Unaudited Condensed Consolidated Statement of Financial Position](index=2&type=section&id=Unaudited%20Condensed%20Consolidated%20Statement%20of%20Financial%20Position) As of March 31, 2022, total assets significantly increased to €282.2 million, primarily due to a rise in cash and cash equivalents, leading to a substantial increase in shareholders' equity to €116.0 million Consolidated Statement of Financial Position Highlights (in thousands of Euros) | Metric | March 31, 2022 | December 31, 2021 | | :--- | :--- | :--- | | **Cash and cash equivalents** | 247,316 | 132,994 | | **Total assets** | 282,182 | 174,646 | | **Total liabilities** | 166,195 | 150,583 | | **Total shareholders' equity** | 115,987 | 24,063 | [Unaudited Condensed Consolidated Statement of Profit/(Loss)](index=3&type=section&id=Unaudited%20Condensed%20Consolidated%20Statement%20of%20Profit%2F%28Loss%29) For Q1 2022, the company reported a net profit of €85.7 million, a significant reversal from a prior-year loss, driven by a massive increase in collaboration revenue to €102.9 million Statement of Profit/(Loss) Summary (in thousands of Euros) | Metric | Three months ended March 31, 2022 | Three months ended March 31, 2021 | | :--- | :--- | :--- | | **Revenue from collaboration agreements** | 102,907 | 7,403 | | **Research and development expenses** | (25,144) | (23,049) | | **General and administrative expenses** | (9,278) | (8,431) | | **Operating result** | 68,492 | (23,838) | | **Net profit/(loss)** | 85,662 | (22,813) | | **Basic EPS (€)** | 1.36 | (0.36) | [Unaudited Condensed Consolidated Statement of Cash Flows](index=5&type=section&id=Unaudited%20Condensed%20Consolidated%20Statement%20of%20Cash%20Flows) Net cash from operating activities significantly improved to a €109.1 million inflow in Q1 2022, primarily driven by net profit and a large upfront payment, increasing cash to €247.3 million Cash Flow Summary (in thousands of Euros) | Metric | Three months ended March 31, 2022 | Three months ended March 31, 2021 | | :--- | :--- | :--- | | **Net cash from operating activities** | 109,102 | (16,657) | | **Net cash from investing activities** | 5,836 | 2,559 | | **Net cash from financing activities** | (689) | (482) | | **Net increase/(decrease) in cash** | 114,249 | (14,580) | | **Cash and cash equivalents at end of period** | 247,316 | 195,333 | [Unaudited Condensed Consolidated Statement of Changes in Shareholders' Equity](index=6&type=section&id=Unaudited%20Condensed%20Consolidated%20Statement%20of%20Changes%20in%20Shareholders'%20equity) Shareholders' equity substantially increased to €116.0 million as of March 31, 2022, primarily driven by the €85.7 million net profit and share-based compensation Changes in Shareholders' Equity (in thousands of Euros) | Metric | As of March 31, 2022 | As of January 1, 2022 | | :--- | :--- | :--- | | **Total shareholders' equity** | 115,987 | 24,063 | | **Key Changes in Q1 2022** | | | | Net profit | +85,662 | | | Equity-settled share-based compensation | +5,702 | | [Notes to the Unaudited Condensed Consolidated Financial Statements](index=7&type=section&id=Notes%20to%20the%20Unaudited%20Condensed%20Consolidated%20Financial%20Statements) [Significant Events and Changes](index=7&type=section&id=2.%20Significant%20events%20and%20changes%20in%20the%20current%20reporting%20period) The quarter's significant event was the BMS agreement, effective January 26, 2022, yielding a €133 million upfront payment and €91 million in license revenue, with no significant COVID-19 impact - The company entered into a collaboration agreement with Bristol-Myers-Squibb (BMS) which became effective on January 26, 2022, receiving a **€133 million ($150 million)** upfront cash payment[16](index=16&type=chunk) - For the BMS agreement, the company recognized **€91 million** of revenue related to the IMA401 license and deferred **€42 million** for clinical trial services. An additional **€1.5 million** in service revenue was recognized in the quarter[25](index=25&type=chunk) - Management stated that to date, the COVID-19 pandemic has not significantly impacted the Group's operations, though it continues to monitor potential future risks[27](index=27&type=chunk) [Revenue from Collaboration Agreements](index=9&type=section&id=6.%20Revenue%20from%20collaboration%20agreements) Collaboration revenue surged to €102.9 million in Q1 2022, primarily driven by the new BMS agreement contributing €98.4 million, including €91.3 million from the IMA401 license Revenue by Collaborator (in thousands of Euros) | Collaborator | Three months ended March 31, 2022 | Three months ended March 31, 2021 | | :--- | :--- | :--- | | Amgen | — | 257 | | Genmab | 2,920 | 2,236 | | BMS | 98,425 | 3,293 | | GSK | 1,562 | 1,617 | | **Total** | **102,907** | **7,403** | - The company has not recognized any milestone revenue or received any royalty payments under its collaboration agreements as of March 31, 2022[41](index=41&type=chunk) [Financial Result](index=11&type=section&id=7.%20Financial%20result) The financial result was a positive €17.2 million in Q1 2022, primarily due to a **€16.5 million** gain from the change in fair value of warrant liabilities as the warrant price decreased Financial Result Breakdown (in thousands of Euros) | Metric | Three months ended March 31, 2022 | Three months ended March 31, 2021 | | :--- | :--- | :--- | | Financial income | 1,759 | 3,464 | | Financial expenses | (1,117) | (1,224) | | Change in fair value of warrant liabilities | 16,528 | (1,215) | | **Financial result** | **17,170** | **1,025** | - The fair value of warrants decreased from **€3.88** per warrant at year-end 2021 to **€1.58** as of March 31, 2022, resulting in a **€16.5 million** non-cash gain[44](index=44&type=chunk) [Share-Based Payments](index=12&type=section&id=12.%20Share-based%20payments) Total share-based compensation expense decreased to **€5.7 million** in Q1 2022, primarily due to Matching Stock Options becoming fully vested in July 2021 Share-Based Compensation Expense (in thousands of Euros) | Expense Category | Three months ended March 31, 2022 | Three months ended March 31, 2021 | | :--- | :--- | :--- | | Research and development expenses | 3,268 | 4,898 | | General and administrative expenses | 2,434 | 3,406 | | **Total share-based compensation** | **5,702** | **8,304** | - The decrease in share-based compensation expense was mainly because Matching Stock Options fully vested on July 31, 2021[64](index=64&type=chunk) [Events Occurring After the Reporting Period](index=16&type=section&id=15.%20Events%20occurring%20after%20the%20reporting%20period) After quarter-end, Immatics issued **2.4 million** shares for **€16.8 million** and entered a new strategic collaboration with BMS for allogeneic therapies, receiving an **$80 million** total upfront payment - After March 31, 2022, the company issued **2.4 million** shares under its ATM agreement, collecting gross proceeds of **€16.8 million ($18.5 million)**[71](index=71&type=chunk) - A new strategic collaboration was initiated with Bristol Myers Squibb for allogeneic therapies, with Immatics receiving a **$60 million** upfront payment. An existing collaboration was also expanded for an additional **$20 million**[72](index=72&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=17&type=section&id=MANAGEMENT'S%20DISCUSSION%20AND%20ANALYSIS%20OF%20FINANCIAL%20CONDITION%20AND%20RESULTS%20OF%20OPERATIONS) [Overview](index=17&type=section&id=Overview) Immatics is a clinical-stage biotechnology company developing TCR-based immunotherapies, with **€252.7 million** in cash as of March 31, 2022, sufficient to fund operations for at least the next 12 months - The company is a clinical-stage biotech focused on developing TCR-based immunotherapies for cancer, with a proprietary pipeline of seven therapeutic programs and nine partnered programs[74](index=74&type=chunk)[76](index=76&type=chunk) - As of March 31, 2022, the company held **€252.7 million** in cash, cash equivalents, and other financial assets and believes it has sufficient capital for at least the next 12 months[78](index=78&type=chunk) [Results of Operations](index=20&type=section&id=Results%20of%20Operations) Q1 2022 operating results were dominated by a **€95.5 million** increase in collaboration revenue from the BMS agreement, with moderate increases in R&D and G&A expenses [Revenue from Collaboration Agreements](index=20&type=section&id=Revenue%20from%20Collaboration%20Agreements_MD%26A) Collaboration revenue increased to **€102.9 million** in Q1 2022, primarily due to the new BMS agreement, which included **€91.3 million** from the IMA401 license Revenue by Collaborator (in thousands of Euros) | Collaborator | Q1 2022 | Q1 2021 | | :--- | :--- | :--- | | Amgen | € — | € 257 | | Genmab | 2,920 | 2,236 | | BMS | 98,425 | 3,293 | | GSK | 1,562 | 1,617 | | **Total** | **€102,907** | **€7,403** | [Research and Development Expenses](index=21&type=section&id=Research%20and%20Development%20Expenses_MD%26A) Total R&D expenses rose to **€25.1 million** in Q1 2022, driven by higher personnel costs, partially offset by decreased share-based compensation due to vested options R&D Expense Breakdown (in thousands of Euros) | Category | Q1 2022 | Q1 2021 | | :--- | :--- | :--- | | **Direct external expenses** | | | | ACT Programs | € 4,756 | € 4,055 | | TCR Bispecifics Programs | 1,063 | 2,354 | | **Indirect R&D expenses** | | | | Personnel related | € 8,979 | € 5,359 | | Share-based compensation | 3,268 | 4,898 | | **Total R&D expenses** | **€25,144** | **€23,049** | [General and Administrative Expenses](index=22&type=section&id=General%20and%20Administrative%20Expenses_MD%26A) G&A expenses increased to **€9.3 million** in Q1 2022, primarily due to higher personnel and other external expenses, partially offset by lower share-based compensation G&A Expense Breakdown (in thousands of Euros) | Category | Q1 2022 | Q1 2021 | | :--- | :--- | :--- | | Share-based compensation | € 2,434 | € 3,406 | | Personnel related | 2,614 | 2,042 | | Professional and consulting fees | 1,290 | 1,508 | | Other external expenses | 2,940 | 1,475 | | **Total G&A expenses** | **€ 9,278** | **€ 8,431** | [Liquidity and Capital Resources](index=23&type=section&id=Liquidity%20and%20Capital%20Resources) Liquidity significantly strengthened in Q1 2022, with cash rising to **€247.3 million** due to the BMS upfront payment, and the company generated positive operating cash flow for the first time [Sources of Liquidity](index=23&type=section&id=Sources%20of%20Liquidity) The company's cash increased to **€247.3 million** in Q1 2022 due to a **€133.0 million** BMS payment, and it has an active ATM program for future funding - Cash and cash equivalents increased from **€133.0 million** as of December 31, 2021 to **€247.3 million** as of March 31, 2022, following the receipt of a **€133.0 million** upfront payment from BMS[116](index=116&type=chunk) - The company believes its existing cash will be sufficient to fund operating expenses and capital expenditure requirements for at least the next 12 months[117](index=117&type=chunk) [Cash Flows](index=23&type=section&id=Cash%20Flows) Net cash from operating activities was a **€109.1 million** inflow in Q1 2022, driven by net income from the BMS collaboration, with positive investing and minor financing outflows Cash Flow Summary (in thousands of Euros) | Activity | Q1 2022 | Q1 2021 | | :--- | :--- | :--- | | Operating activities | € 109,102 | € (16,657) | | Investing activities | 5,836 | 2,559 | | Financing activities | (689) | (482) | | **Total cash flow** | **€ 114,249** | **€ (14,580)** | [Critical Accounting Estimates](index=25&type=section&id=Critical%20Accounting%20Estimates) Critical accounting estimates involve significant judgment, particularly in revenue recognition for collaboration agreements like the BMS deal, share-based compensation, and deferred tax asset assessment - Main areas requiring significant estimates are revenue recognition, research and development expenses, share-based compensation, and income taxes[131](index=131&type=chunk) - For the latest BMS collaboration, the company concluded there were two distinct performance obligations: the license (revenue recognized at a point in time) and clinical trial services (revenue recognized over time)[135](index=135&type=chunk) - Due to a history of losses, the company has not recognized any deferred tax assets on tax losses carried forward, despite the one-time net income in Q1 2022[140](index=140&type=chunk) [Quantitative and Qualitative Disclosures about Market Risk](index=26&type=section&id=Quantitative%20and%20Qualitative%20Disclosures%20about%20Market%20Risk) The company is exposed to market risks including interest rate, credit, and significant currency risk, with **37%** of cash in USD, and market price risk from fair-valued warrant liabilities - The main financial risks are interest rate risk, liquidity risk, and currency exchange risk[142](index=142&type=chunk) - The company is exposed to currency risk, as approximately **37%** of its cash and cash equivalents held in Germany as of March 31, 2022, were denominated in U.S. Dollars[147](index=147&type=chunk) - The company is exposed to market risk from its warrants, which are fair-valued each period. A **10%** change in the warrant price would result in a **€1.1 million** gain or loss before tax[149](index=149&type=chunk) [Other Information](index=27&type=section&id=OTHER%20INFORMATION) [Legal Proceedings](index=27&type=section&id=Legal%20Proceedings) The company is not currently a party to any legal proceedings expected to have a material adverse effect on its business - As of the report date, the company is not a party to any legal proceedings that management believes would likely have a material adverse effect on the business[150](index=150&type=chunk) [Risk Factors](index=27&type=section&id=Risk%20Factors) No material changes have occurred from the risk factors described in the company's Annual Report on Form 20-F - No material changes have occurred from the risk factors described in the company's Annual Report[151](index=151&type=chunk)
Immatics N.V.(IMTX) - 2021 Q4 - Annual Report
2022-03-23 13:22
PART I [ITEM 3. KEY INFORMATION](index=7&type=section&id=ITEM%203.%20KEY%20INFORMATION) The company faces significant financial, developmental, regulatory, manufacturing, and intellectual property risks [Risks Related to Our Financial Position and Need for Additional Capital](index=8&type=section&id=Risks%20Related%20to%20Our%20Financial%20Position%20and%20Need%20for%20Additional%20Capital) The company has a history of significant operating losses, requires additional capital, and faces currency exchange risks Historical Net Losses | Year Ended December 31 | Net Loss (€ millions) | | :--- | :--- | | 2021 | 93.3 | | 2020 | 211.8 | | 2019 | 32.5 | | **Accumulated Losses (as of Dec 31, 2021)** | **537.8** | - The company anticipates needing additional capital for operations, with cash and financial assets of **€145.1 million** as of December 31, 2021, deemed sufficient for at least the next twelve months[43](index=43&type=chunk)[45](index=45&type=chunk) - The company has significant net operating loss carryforwards of **€219.8 million in Germany** and **€135.6 million in the U.S.**, but their usability is subject to limitations[51](index=51&type=chunk) - The company operates internationally and is exposed to **currency exchange rate fluctuations**, particularly between the Euro and the U.S. dollar[50](index=50&type=chunk) [Risks Related to the Development of Our Product Candidates](index=12&type=section&id=Risks%20Related%20to%20the%20Development%20of%20Our%20Product%20Candidates) Novel immunotherapy products face uncertainties in clinical trials, manufacturing complexity, and potential adverse side effects - The company's novel human immunotherapy products face significant uncertainties regarding clinical trial requirements and regulatory acceptance[54](index=54&type=chunk) - Clinical trials for **ACT and TCR Bispecifics** are expensive and difficult to design, with costs likely to be significantly higher than for conventional therapies[73](index=73&type=chunk)[74](index=74&type=chunk) - Product candidates may cause undesirable side effects, with **Grade ≥3 treatment-emergent adverse events** and a dose-limiting toxicity observed in trials[75](index=75&type=chunk)[76](index=76&type=chunk) - Demonstrating comparability between products from old and new manufacturing processes may require additional clinical testing, increasing costs and timelines[90](index=90&type=chunk) [Risks Related to Regulatory Approval of Our Product Candidates](index=20&type=section&id=Risks%20Related%20to%20Regulatory%20Approval%20of%20Our%20Product%20Candidates) The regulatory approval process for novel therapies is lengthy and uncertain, with evolving requirements and post-marketing obligations - Obtaining regulatory approval from the FDA and EMA is a lengthy and uncertain process, with additional challenges due to the novelty of T cell directed therapies[93](index=93&type=chunk)[94](index=94&type=chunk)[95](index=95&type=chunk) - The **evolving regulatory landscape** for gene and cell therapies could lengthen the review process and increase development costs[100](index=100&type=chunk)[102](index=102&type=chunk)[104](index=104&type=chunk) - Seeking **accelerated approval** does not guarantee a faster review and requires post-marketing confirmatory trials[114](index=114&type=chunk)[115](index=115&type=chunk) - Ongoing compliance with comprehensive regulations is required post-approval, and failure can result in significant penalties, including withdrawal of approval[126](index=126&type=chunk)[127](index=127&type=chunk)[129](index=129&type=chunk) [Risk Related to the Manufacturing of Our Product Candidates](index=27&type=section&id=Risk%20Related%20to%20the%20Manufacturing%20of%20Our%20Product%20Candidates) Complex, patient-specific manufacturing processes are susceptible to failures, and scaling up production presents significant challenges - Manufacturing of **ACTengine products** is a complex, patient-specific process susceptible to product loss, contamination, and logistical failures[132](index=132&type=chunk)[133](index=133&type=chunk) - Scaling the second-generation manufacturing process carries risks of **cost overruns, stability issues, and lot inconsistency**[134](index=134&type=chunk) - Manufacturing of **TCR Bispecifics (TCER)** is also complex and prone to product loss from contamination, equipment failure, and scaling difficulties[137](index=137&type=chunk) - The company has no experience operating a large-scale manufacturing site and currently relies on a leased facility, which requires significant resources to expand[140](index=140&type=chunk)[147](index=147&type=chunk) [Risks Related to the Commercialization of Our Product Candidates](index=32&type=section&id=Risks%20Related%20to%20the%20Commercialization%20of%20Our%20Product%20Candidates) The company lacks commercial infrastructure and faces challenges in market acceptance, reimbursement, and healthcare reform - The company has **no sales force or commercial infrastructure** and will incur significant costs and risks to build these capabilities[156](index=156&type=chunk)[157](index=157&type=chunk) - Commercial success is highly dependent on **market acceptance** by physicians, patients, and payors[161](index=161&type=chunk)[162](index=162&type=chunk) - The market opportunities for product candidates may be **smaller than estimated** based on current projections[163](index=163&type=chunk) - Obtaining **adequate coverage and reimbursement** from payors is essential but uncertain due to pricing pressures and cost-containment initiatives[168](index=168&type=chunk)[172](index=172&type=chunk) [Risks Related to Our Relationships with Third Parties](index=35&type=section&id=Risks%20Related%20to%20Our%20Relationships%20with%20Third%20Parties) The company's heavy reliance on third-party CROs, CMOs, and strategic collaborators introduces significant operational risks - The company relies on third-party CROs to conduct clinical trials, reducing direct control over trial conduct and data quality[175](index=175&type=chunk)[177](index=177&type=chunk) - Manufacturing depends on third-party CMOs and suppliers, with **potential for supply chain disruption** from single-source providers[180](index=180&type=chunk)[183](index=183&type=chunk) - The termination of key collaboration agreements could result in the **loss of future funding, milestones, and royalty payments**[192](index=192&type=chunk)[194](index=194&type=chunk) - Development of required companion diagnostics is outsourced, and failure by partners could harm the commercialization of therapeutic products[189](index=189&type=chunk) [Risks Related to Our Intellectual Property](index=40&type=section&id=Risks%20Related%20to%20Our%20Intellectual%20Property) Success depends on maintaining patent protection in a highly uncertain biotech landscape with risks of infringement claims - The company's success depends on obtaining and maintaining patent protection, but patents may be **challenged, invalidated, or held unenforceable**[200](index=200&type=chunk)[203](index=203&type=chunk) - The company may face **infringement lawsuits** from third parties, which could be expensive and result in damages or injunctions[205](index=205&type=chunk)[208](index=208&type=chunk) - There is a risk of claims **challenging the inventorship or ownership** of the company's patents, which could lead to loss of valuable IP rights[216](index=216&type=chunk)[217](index=217&type=chunk) - Protecting intellectual property rights globally is challenging, as laws in foreign jurisdictions may not be as protective as in the U.S[224](index=224&type=chunk)[226](index=226&type=chunk) [Risks Related to Our Business and Industry](index=48&type=section&id=Risks%20Related%20to%20Our%20Business%20and%20Industry) The business is subject to pandemic disruptions, dependency on key personnel, intense competition, and complex regulations - The **COVID-19 pandemic** could adversely affect business operations by delaying clinical trials and disrupting supply chains[235](index=235&type=chunk)[238](index=238&type=chunk) - The company is **highly dependent on key management and scientific personnel**, and competition for talent is intense[241](index=241&type=chunk)[244](index=244&type=chunk) - The biotechnology industry is **intensely competitive**, with rivals possessing greater financial and R&D resources[251](index=251&type=chunk) - Non-compliance with complex healthcare, data protection (e.g., GDPR, HIPAA), and anti-corruption laws could result in significant penalties[256](index=256&type=chunk)[260](index=260&type=chunk)[277](index=277&type=chunk) [Risks Related to Ownership of Our Securities](index=63&type=section&id=Risks%20Related%20to%20Ownership%20of%20Our%20Securities) Security prices are volatile, warrants may expire worthless, and shareholder rights are governed by Dutch law - The market price of the company's securities (IMTX, IMTXW) is subject to **high volatility**[302](index=302&type=chunk) - The company's warrants have an exercise price of **$11.50 per share** and may expire worthless if the share price does not surpass this level[303](index=303&type=chunk) - As a Dutch company, shareholder rights are governed by **Dutch law**, which may make it difficult for U.S. investors to enforce judgments[312](index=312&type=chunk)[317](index=317&type=chunk) - The company's status as a **foreign private issuer** and emerging growth company exempts it from certain U.S. reporting standards[327](index=327&type=chunk)[330](index=330&type=chunk)[331](index=331&type=chunk) [Risks Related to Taxation](index=70&type=section&id=Risks%20Related%20to%20Taxation) The company faces tax risks including potential PFIC classification, uncertainty of its German tax residency, and dividend withholding tax - The company may be classified as a **Passive Foreign Investment Company (PFIC)**, which could lead to adverse U.S. tax consequences for shareholders[334](index=334&type=chunk) - A change in the company's tax residency from Germany could result in **different and potentially higher tax liabilities**[335](index=335&type=chunk)[337](index=337&type=chunk) - Future dividends may be subject to **withholding tax in both Germany and the Netherlands**[338](index=338&type=chunk)[339](index=339&type=chunk) [ITEM 4. INFORMATION ON THE COMPANY](index=72&type=section&id=ITEM%204.%20INFORMATION%20ON%20THE%20COMPANY) The company develops TCR-based immunotherapies for solid tumors using its ACT and TCER therapeutic modalities [A. History and Development of the Company](index=72&type=section&id=A.%20History%20and%20Development%20of%20the%20Company) The company went public in July 2020 through a business combination, with its primary operations held in a German subsidiary - Immatics N.V. became a public company on **July 1, 2020**, following a business combination with ARYA Sciences Acquisition Corp[342](index=342&type=chunk) [B. Business Overview](index=72&type=section&id=B.%20Business%20Overview) The company is advancing a pipeline of proprietary and partnered TCR-based therapies driven by its discovery platforms - The company's pipeline includes **eight proprietary programs and nine partnered programs** utilizing its ACT and TCER platforms[347](index=347&type=chunk) IMA203 Phase 1 Interim Clinical Trial Data (as of Oct 5, 2021) | Metric | Result | | :--- | :--- | | Patients Treated | 18 | | Evaluable Patients | 16 | | Disease Control Rate | 94% (15/16) | | Objective Response Rate (RECIST 1.1) | 50% (8/16) | | Objective Response Rate (Doses > DL1) | 62% (8/13) | - The lead TCR Bispecific candidate, IMA401, is being developed with Bristol Myers Squibb under a collaboration including a **$150 million upfront payment**[357](index=357&type=chunk) - The proprietary **XPRESIDENT and XCEPTOR** technology platforms are central to the company's strategy for discovering novel cancer targets and TCRs[362](index=362&type=chunk) [C. Organizational Structure](index=120&type=section&id=C.%20Organizational%20Structure) The company consists of a Dutch parent with wholly-owned operating subsidiaries in Germany and the United States Principal Subsidiaries | Company | Jurisdiction of Incorporation | Ownership Interest | | :--- | :--- | :--- | | Immatics Biotechnologies GmbH | Germany | 100% | | Immatics US, Inc. | Delaware, United States | 100% | [D. Property, Plant and Equipment](index=120&type=section&id=D.%20Property%2C%20Plant%20and%20Equipment) The company operates from facilities in Germany and the US, with T cell manufacturing conducted at a leased cGMP facility in Houston - The company's main facilities are located in **Tübingen and Munich, Germany, and Houston, Texas, USA**[618](index=618&type=chunk)[619](index=619&type=chunk) - Clinical T cell products are manufactured at a leased **cGMP facility at UTHealth** in Houston, Texas[619](index=619&type=chunk) [ITEM 5. OPERATING AND FINANCIAL REVIEW AND PROSPECTS](index=121&type=section&id=ITEM%205.%20OPERATING%20AND%20FINANCIAL%20REVIEW%20AND%20PROSPECTS) The company's 2021 revenue increased while its net loss narrowed, ending the year with sufficient cash to fund near-term operations [A. Operating Results](index=122&type=section&id=A.%20Operating%20Results) In 2021, revenue grew to €34.8 million, R&D expenses rose, and the net loss decreased significantly to €93.3 million Consolidated Statement of Operations Summary (Years ended Dec 31) | (in € thousands) | 2021 | 2020 | | :--- | :--- | :--- | | Revenue from collaboration agreements | 34,763 | 31,253 | | Research and development expenses | (87,574) | (67,085) | | General and administrative expenses | (33,808) | (34,186) | | **Operating result** | **(86,294)** | **(69,715)** | | Share listing expense | — | (152,787) | | **Net loss** | **(93,335)** | **(211,841)** | - Revenue increased by **€3.5 million** year-over-year, mainly due to recognizing deferred revenue from the discontinued Amgen collaboration[655](index=655&type=chunk) - R&D expenses increased by **€20.5 million** year-over-year, driven by higher clinical trial activity and increased headcount[657](index=657&type=chunk)[660](index=660&type=chunk) [B. Liquidity and Capital Resources](index=129&type=section&id=B.%20Liquidity%20and%20Capital%20Resources) The company holds sufficient cash and financial assets, supplemented by a recent upfront payment, to fund operations for at least 12 months - As of December 31, 2021, the company held **€133.0 million in cash and cash equivalents** and €12.1 million in other financial assets[674](index=674&type=chunk)[982](index=982&type=chunk) Cash Flow Summary (Years ended Dec 31) | (in € thousands) | 2021 | 2020 | | :--- | :--- | :--- | | Net cash used in operating activities | (81,784) | (85,610) | | Net cash provided by / (used in) investing activities | 7,493 | (15,949) | | Net cash (used in) / provided by financing activities | (2,613) | 207,883 | - The company believes its existing cash, along with a **$150 million upfront payment from BMS** received in February 2022, will fund operations for at least the next 12 months[675](index=675&type=chunk) [E. Critical Accounting Estimates](index=133&type=section&id=E.%20Critical%20Accounting%20Estimates) Key accounting estimates involve revenue recognition from collaborations, share-based compensation valuation, and deferred tax asset assessment - Revenue from collaboration agreements is recognized over time on a **cost-to-cost basis**, requiring significant management judgment[702](index=702&type=chunk)[705](index=705&type=chunk) - The fair value of **share-based compensation** is determined using valuation models that require assumptions about volatility and exercise patterns[706](index=706&type=chunk)[707](index=707&type=chunk)[712](index=712&type=chunk) - Recognition of **deferred tax assets** is based on judgment of future taxable profits, and none have been recognized to date due to a history of losses[708](index=708&type=chunk) [ITEM 6. DIRECTORS, SENIOR MANAGEMENT AND EMPLOYEES](index=134&type=section&id=ITEM%206.%20DIRECTORS%2C%20SENIOR%20MANAGEMENT%20AND%20EMPLOYEES) The company is led by an experienced executive team and board, overseeing a highly educated workforce focused on R&D 2021 Compensation Summary (€ thousands) | Group | Periodically-paid remuneration | Bonuses | Share-based compensation expense | Total compensation | | :--- | :--- | :--- | :--- | :--- | | **CEO (Harpreet Singh)** | 484 | 285 | 7,946 | 8,715 | | **All other executives** | 1,997 | 1,032 | 9,070 | 12,099 | | **Non-Executive Directors** | 348 | - | 1,751 | 2,099 | - As of December 31, 2021, the company had **381 full-time employees**, with a large portion dedicated to R&D and 144 holding doctorate degrees[770](index=770&type=chunk)[771](index=771&type=chunk) - The Board of Directors has three standing committees: **Audit, Compensation, and Nominating and Corporate Governance**[763](index=763&type=chunk) [ITEM 7. MAJOR SHAREHOLDERS AND RELATED PARTY TRANSACTIONS](index=154&type=section&id=ITEM%207.%20MAJOR%20SHAREHOLDERS%20AND%20RELATED%20PARTY%20TRANSACTIONS) A few major shareholders hold significant voting power, and related party transactions include an Investor Rights Agreement 5% or Greater Shareholders (as of Jan 31, 2022) | Shareholder | Percentage of Ordinary Shares | | :--- | :--- | | dievini Hopp BioTech holding GmbH & Co. KG | 27.3% | | Baker Bros. Advisors LP | 7.0% | | Nantahala Capital Management, LLC | 6.3% | | ARYA Sciences Holdings | 5.6% | - An **Investor Rights Agreement** provides certain shareholders with the right to designate individuals for election to the Board of Directors[782](index=782&type=chunk) [ITEM 8. FINANCIAL INFORMATION](index=157&type=section&id=ITEM%208.%20FINANCIAL%20INFORMATION) This section contains the IFRS financial statements and notes the company's dividend policy and a legal proceeding - The company is involved in a legal proceeding with Immunocore Limited regarding an opposition to the **IMMTAX trademark**[787](index=787&type=chunk) - The company has **never declared or paid cash dividends** and does not plan to in the foreseeable future[789](index=789&type=chunk) [ITEM 11. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK](index=180&type=section&id=ITEM%2011.%20QUANTITATIVE%20AND%20QUALITATIVE%20DISCLOSURES%20ABOUT%20MARKET%20RISK) The company is primarily exposed to interest rate, credit, and currency risks from its financial assets and international operations - The main financial risks are identified as **interest rate risk, credit risk, and currency exchange risk**[927](index=927&type=chunk) - The company has significant **currency risk exposure** due to holding U.S. dollar-denominated assets while its functional currency is the Euro[931](index=931&type=chunk)[932](index=932&type=chunk) [ITEM 15. CONTROLS AND PROCEDURES](index=182&type=section&id=ITEM%2015.%20CONTROLS%20AND%20PROCEDURES) Management concluded that disclosure controls were effective and that two previously identified material weaknesses have been remediated - Management concluded that **disclosure controls and procedures were effective** as of December 31, 2021[941](index=941&type=chunk) - The company successfully **remediated two material weaknesses** in internal control over financial reporting that were identified as of December 31, 2020[948](index=948&type=chunk)[950](index=950&type=chunk) [ITEM 16. CORPORATE GOVERNANCE AND OTHER DISCLOSURES](index=183&type=section&id=ITEM%2016.%20CORPORATE%20GOVERNANCE%20AND%20OTHER%20DISCLOSURES) The company follows Dutch corporate governance practices and discloses details on its audit committee and accountant fees - The Audit Committee includes two members who qualify as **"audit committee financial experts"**[951](index=951&type=chunk) Principal Accountant Fees (€ thousands) | Fee Type | 2021 | 2020 | | :--- | :--- | :--- | | Audit Fees | 1,298 | 1,042 | | Audit-Related Fees | — | — | | Tax Fees | — | — | | All Other Fees | — | — | | **Total Fees** | **1,298** | **1,042** | - As a foreign private issuer, the company follows its **home country (Netherlands) corporate governance practices**, which differ from certain Nasdaq standards[961](index=961&type=chunk)[965](index=965&type=chunk) PART III [ITEM 18. FINANCIAL STATEMENTS](index=186&type=section&id=ITEM%2018.%20FINANCIAL%20STATEMENTS) This section presents the company's audited consolidated financial statements prepared in accordance with IFRS Consolidated Statement of Financial Position Highlights (as of Dec 31) | (in € thousands) | 2021 | 2020 | | :--- | :--- | :--- | | **Total Assets** | **174,646** | **254,646** | | Cash and cash equivalents | 132,994 | 207,530 | | **Total Liabilities** | **150,583** | **167,259** | | Deferred revenue | 98,627 | 132,075 | | **Total Shareholders' Equity** | **24,063** | **87,387** | - The financial statements were prepared in conformity with **International Financial Reporting Standards (IFRS)** as issued by the IASB[976](index=976&type=chunk) [ITEM 19. EXHIBITS](index=186&type=section&id=ITEM%2019.%20EXHIBITS) This section lists all exhibits filed with the annual report, including articles of association and material contracts - Key filed exhibits include the company's **Articles of Association, material contracts**, and collaboration agreements with partners like Bristol-Myers Squibb[969](index=969&type=chunk)[972](index=972&type=chunk)
Immatics N.V.(IMTX) - 2021 Q4 - Annual Report
2022-03-23 11:08
Exhibit 99.1 PRESS RELEASE Immatics Announces Full Year 2021 Financial Results and Corporate Update Tuebingen, Germany and Houston, TX, March 23, 2022 – Immatics N.V. (NASDAQ: IMTX; "Immatics"), a clinical-stage biopharmaceutical company active in the discovery and development of T cell redirecting cancer immunotherapies, today provided an update on its corporate progress and reported financial results for the quarter and full year ended December 31, 2021. Harpreet Singh, Ph.D., CEO and Co-Founder of Immati ...
Immatics (IMTX) Investor Presentation - Slideshow
2021-12-07 21:35
Unlocking Immunotherapies for Solid Cancer Patients Immatics Corporate Presentation, November 2021 © Immatics. Not for further reproduction or distribution. Forward-Looking Statements This presentation ("Presentation") is provided by Immatics N.V. ("Immatics" or the "Company") for informational purposes only. The information contained herein does not purport to be all-inclusive and Immatics nor any of its affiliates nor any of its or their control persons, officers, directors, employees or representatives m ...
Immatics N.V.(IMTX) - 2020 Q4 - Annual Report
2021-03-30 11:51
☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Table of Contents For the fiscal year ended December 31, 2020 OR (Mark One) ☐ REGISTRATION STATEMENT PURSUANT TO SECTION 12(b) OR (g) OF THE SECURITIES EXCHANGE ACT OF 1934 OR ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 20-F Securities for which there is a reporting obligation pursuant to Section 15( ...