Workflow
Immatics N.V.(IMTX)
icon
Search documents
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 "$," and "U.S. dollars" mean U.S. dollars and all references to " ...
Immatics N.V.(IMTX) - 2022 Q2 - Quarterly Report
2022-06-02 11:17
Exhibit 99.1 PRELIMINARY NOTE The unaudited condensed Consolidated Financial Statements for the three-month period ended March 31, 2022, included herein, have been prepared in accordance with International Accounting Standard 34 ("Interim Financial Reporting"), as issued by the International Accounting Standards Board ("IASB"). The Consolidated Financial Statements are presented in euros. All references in this interim report to "$," and "U.S. dollars" mean U.S. dollars and all references to "€" and "euros" ...
Immatics N.V.(IMTX) - 2021 Q4 - Annual Report
2022-03-23 13:22
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, 2021 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) - 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( ...